KR20240032823A - Expandable sheath for introducing intravascular delivery devices into the body - Google Patents

Abstract

Embodiments of the expandable sheath may be used with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient's body. This embodiment can minimize trauma to the blood vessel by temporarily dilating a portion of the introducer canal to accommodate the delivery device after passage of the prosthetic device and then returning it to its original diameter. Some embodiments may include a sheath having a tubular inner liner wound in a helical scroll sliding capable configuration. The disclosed sheath is configured to expand from a predetermined resting diameter (dT) to an expanded diameter (de) during application of a radially outward force by passage of the medical device through the sheath.

Description

Expandable sheath for introducing intravascular delivery devices into the body

Cross-reference to related applications

This application is related to U.S. Provisional Patent Application No. 63/209,337, filed on June 10, 2021, U.S. Provisional Patent Application No. 63/214,605, filed on June 24, 2021, and U.S. Patent Application No. 63/214,605, filed on June 24, 2021 Claims the benefit of Provisional Application No. 63/214,349, and U.S. Provisional Patent Application No. 63/323,429, filed March 24, 2022, the contents of which are hereby incorporated by reference in their entirety.

Technology field

This application relates to sheaths for use in catheter-based techniques for the repair and/or replacement of heart valves, as well as sheaths for delivering prosthetic devices, such as prosthetic valves, through a patient's vascular system to the heart.

Intravascular delivery catheter assemblies are used to implant prosthetic devices, such as prosthetic valves, into locations within the body that are not readily accessible surgically or where access without invasive surgery is desirable. For example, aortic, mitral, tricuspid and/or pulmonary prosthetic valves can be delivered to the treatment site using minimally invasive surgical techniques.

The introducer sheath can be used to safely introduce the delivery device into the patient's vascular system (e.g., femoral artery). The introducer sheath generally has a housing that includes an elongated sleeve that is inserted into the vasculature and one or more sealing valves that allow the delivery device to be placed in fluid communication with the vasculature with minimal blood loss. Conventional introducer sheaths typically require a tubular loader to be inserted through a seal within the housing to provide an unobstructed path through the housing for the valve mounted on the balloon catheter. Conventional loaders extend from the proximal end of the introducer sheath, thereby reducing the available working length of the delivery device that can be inserted into the body through the sheath.

Prior to introducing a delivery system, conventional methods for accessing a blood vessel, such as the femoral artery, involve dilating the vessel using a number of dilators or sheaths of progressively increasing diameter. This repeated insertion and vasodilation may increase the risk of vascular damage, as well as the time required for the procedure.

Radial expansion of the intravascular sheath has been disclosed. These sheaths tend to have complex mechanisms, such as shafts or ratchet mechanisms, that hold the sheath in an extended configuration once a device with a larger diameter than the original diameter of the sheath is introduced.

However, delivering and/or removing prosthetic devices and other materials to or from patients still poses significant risks to patients. Additionally, access to the vessel remains a challenge due to the relatively large profile of the delivery system, which can cause longitudinal and radial tearing of the vessel during insertion. The delivery system may additionally remove calcified plaque within the blood vessels, creating an additional risk of blood clots caused by the removed plaque.

Accordingly, there is a need in the art for improved introducer sheaths for endovascular systems used to implant valves and other prosthetic devices.

In certain embodiments, provided herein is an expandable sheath that can minimize trauma to the blood vessel by temporarily dilating a portion of the introducer sheath to accommodate the delivery system once the delivery system has passed through it and then returning it to its original diameter. It begins. Aspects of the present invention relate to a sheath having a profile that is smaller than the profile of prior art introducer sheaths. In certain embodiments, use of the sheaths described herein may not only reduce the time required for the procedure, but also allow for the treatment of longitudinal or radial blood vessels by requiring only one sheath rather than multiple differently sized sheaths. It can reduce the risk of rupture or plaque dislodgement. In a further aspect, introduction of the expandable sheath disclosed herein requires only a single vessel insertion, as opposed to requiring multiple insertions for expansion of the vessel.

Aspects of the invention relate to a sheath for introduction of an artificial device, wherein the sheath can include an inner liner and an outer layer. At least a portion of the sheath expands locally from a first diameter (resting diameter) to a second diameter (expanding diameter) when the prosthetic device is pushed through the lumen of the sheath and then expands at least to the first diameter as the prosthetic device passes through. It may be designed or configured to partially revert.

Also disclosed herein is a sheath for delivering a medical device, the sheath having a proximal end and a distal end: a tubular inner liner, the longitudinal portion extending along the length of the tubular inner liner such that the tubular liner is wound in a helical scroll configuration. comprising a tubular inner liner having a slit; wherein the longitudinal slits define a first longitudinal edge and a second longitudinal edge of the tubular inner liner; In a helical scroll configuration, at least a portion of the inner surface of the inner liner helically overlaps at least a portion of the outer surface of the inner liner, and a first longitudinal edge of the inner liner extends along at least a portion of the inner surface of the inner liner. slidable, the second longitudinal edge being slidable along at least a portion of the outer surface of the inner liner; The inner surface of the tubular inner liner defines the lumen of the sheath; The tubular inner liner is configured to helically slide a first edge of the inner liner along at least a portion of the inner surface while applying a radial outward force by passing a medical device through a lumen of the inner liner and It is configured to expand from a resting diameter d _r to an expanded diameter d _e by helically sliding a second edge of the inner liner along at least a portion.

In a further aspect, the tubular liner of the disclosed sheath is configured to extend without substantially forming a gap between the first longitudinal edge and the second longitudinal edge of the tubular inner liner. In a further aspect, the tubular inner liner of the disclosed sheath is further configured to bend while passing through the patient's native anatomy without forming a gap between the first and second longitudinal edges of the tubular inner liner. .

Furthermore, in a further aspect, the longitudinal slit of the tubular inner liner extends from the proximal end of the tubular inner liner to the distal end of the tubular inner liner in a direction offset from the longitudinal axis of the tubular inner liner. In yet a further aspect, the helical configuration of the tubular inner liner can have a predetermined pitch.

In another aspect, the sheath disclosed herein may further include an outer layer. In this exemplary, non-limiting aspect, the outer layer may include one or more layers.

Also provided herein is a method of making a sheath having a proximal end and a distal end, the method comprising: i) offset from the longitudinal axis of the elongated single lumen tube such that a first longitudinal edge and a second longitudinal edge are formed; forming a longitudinal slit by cutting the circumference of the elongated single lumen tube between the proximal and distal ends of the elongated single lumen tube in a direction; ii) at least a portion of the inner surface of the inner liner helically overlaps with at least a portion of the outer surface of the inner liner, wherein the first longitudinal edge of the inner liner slides along at least a portion of the inner surface of the inner liner. rolling the elongated single lumen tube with longitudinal slits into a tubular inner liner having a helical scroll configuration, wherein the second longitudinal edge is slidable along at least a portion of the outer surface of the inner liner, The inner surface of the inner liner includes defining a lumen of the sheath, thereby forming a tubular inner liner; wherein the tubular inner liner is configured to helically slide a first edge of the inner liner along at least a portion of the inner surface while applying a radial outward force by passing a medical device through the lumen of the inner liner and an outer portion of the inner liner. It is configured to expand from a resting diameter d _r to an expanded diameter d _e by helically sliding a second edge of the inner liner along at least a portion of the surface.

In another aspect, rolling includes positioning an elongated single lumen tube having a longitudinal slit on a mandrel having a predetermined diameter to form a helical configuration, wherein the predetermined diameter of the mandrel is an internal It is substantially equal to the resting diameter (d _r ) of the liner. In a further aspect, the formed tubular inner liner is configured to expand substantially without a gap being formed between the first longitudinal edge and the second longitudinal edge of the tubular inner liner. Yet in yet a further aspect, the formed tubular inner liner is configured to bend while passing through the patient's native anatomy without forming a gap between the first and second longitudinal edges of the tubular inner liner.

In another aspect, the method disclosed herein further includes disposing an outer layer over at least a portion of the outer surface of the inner liner. Meanwhile, in another exemplary embodiment, the method disclosed herein may include disposing a braided layer on at least a portion of the outer surface of the tubular inner layer prior to disposing the outer layer. In another aspect, the method may also include disposing an outer layer over the braided layer and at least partially embedding the braided layer within the outer layer. In another aspect, the method may also include disposing a lubricant on at least a portion of the outer surface of the inner liner prior to disposing the outer layer. In this exemplary aspect, the method may include disposing a lubricant on at least a portion of the outer surface of the inner liner before or after disposing the braided layer.

Also disclosed herein is a method of delivering a prosthetic device to a surgical site, the method comprising: inserting an expandable sheath, the expandable sheath of any one of the embodiments herein, at least partially into the patient's vascular system; Locally expanding the tubular liner by sliding the first and second longitudinal edges during passage of the artificial device, and locally folding the sheath at least partially back from a locally expanded state to an unexpanded state after passage of the artificial device. Includes steps.

Additionally or alternatively, the medical device may be an artificial heart valve mounted in a radially compressed condition on the delivery device, wherein advancing the medical device through the sheath advances the delivery device and the artificial heart valve into the patient's vascular system. Includes ordering.

The foregoing and other features and advantages of the present disclosure will become more apparent from the following detailed description taken with reference to the accompanying drawings.

1 is an elevational view of a sheath according to the present disclosure, with an intravascular delivery device for implanting a prosthetic valve.
Figures 2A and 2B are cross-sectional views of aspects of a sheath for introducing a prosthetic device into a patient, and Figure 2C is a perspective view of one component of such a sheath.
Figures 3a, 3b and 3c are elevation views of three versions of the sheath according to the invention, with uniform and variable resting ( d _r ) diameters.
4A -4D illustrate partial elevation views of various example embodiments of braided structures with various PICs in accordance with the present disclosure.
Figures 5A and 5B show cross-sectional views of one aspect of an exemplary inner liner. Figure 5A shows a non-expanded configuration, while Figure 5B shows an expanded configuration.
6A -6E and 6H show cross-sectional views of various aspects of an exemplary sheath. Figures 6F, 6G and 6I show perspective views of various aspects of an exemplary sheath.
7 shows a block diagram of one aspect of a method of making a sheath according to the present disclosure.
8 shows a block diagram of another aspect of a method of making a sheath according to the present disclosure.
Figures 9A-9K show cross-sectional or side views of various method steps of the method shown in Figures 7-8 .
Figure 10 is an elevation view of an expandable sheath and representative housing according to the present invention.
Figure 11 is an enlarged cross-sectional view of the distal end of the sheath of Figure 10 .
Figures 12A-12D are cross-sectional views of the distal end of the exemplary sheath of Figure 14 taken along line 37-37 of Figure 11 .
Figures 13A-13D are cross-sectional views of the proximal section of the sheath of Figure 10 taken along line 38-38 of Figure 11 .
Figure 14 is a cross-sectional view of the sheath of Figure 10 in a resting (non-expanded) configuration, taken along line 39-39 in Figure 11 .
Figure 15 shows a cross-sectional view of the sheath of Figure 14 in an expanded configuration.
Figure 16 shows experimental data for an exemplary sheath in one aspect.
Figure 17 shows experimental data for an exemplary sheath in another aspect.
Figure 18 shows the inner liner of one aspect of an exemplary sheath in a collapsed and unexpanded configuration.
FIG. 19 shows a cross-sectional view of an exemplary sheath in one aspect showing the inner liner and outer layer as shown in FIG. 18 .
Figures 20A-20C illustrate exemplary manufacturing steps for an inner liner as shown in Figure 18 .
Figures 21A-21B show an exemplary sheath in one aspect showing the inner liner and outer layer in a folded and unexpanded configuration. Figure 21A shows a cross-sectional schematic view of the sheath, and Figure 21B shows a side schematic view of the sheath.
Figures 22A-22B depict an exemplary sheath in one aspect. Figure 22a shows a cross-sectional schematic of the sheath in the folded configuration (left) and expanded configuration (right); FIG. 22B shows a snapshot of an example sheath expanding during passage of a medical device.
Figure 23 shows a cross-sectional schematic diagram of an exemplary sheath in one aspect.
Figures 24A-24B show cross-sectional schematics of an exemplary sheath in one aspect.
Figures 25A-25H illustrate various inner liner combinations for example sheaths. Figures 25A-25D show cross-sectional views of various liners prior to forming an exemplary inner liner; 25E-25H show various cross-sectional views of an exemplary inner liner in a helical configuration.
Figure 26 shows a side view of an example lubricant pattern disposed on an example inner liner in one aspect.
Figures 27A-27B show cross-sectional views of an exemplary sheath in a collapsed configuration ( Figure 27A ) and an expanded configuration ( Figure 27B ), with a joint between the inner and outer liners.
Figures 28A-28C illustrate various methods of forming a bond between the inner liner and outer layer of an exemplary sheath.
Figures 29A-29F show schematics of the reinforcement jacket effect ( Figures 25A-25D ) and the balloon guard effect on patient anatomy ( Figures 25A-25B and 25E-25F ).
Figures 30A-30B show schematic diagrams of reinforcement jackets present in an exemplary sheath in one aspect.
Figure 31 shows a method of making an exemplary sheath in one aspect.
Figure 32 shows an exemplary sheath in one aspect.
Figure 33 shows an exemplary sheath in one aspect.
Figure 34 shows an exemplary sheath in one aspect.
Figure 35 is a cross-sectional view of an exemplary sheath according to another aspect.
Figure 36 is a cross-sectional view of an exemplary sheath according to another aspect.
Figure 37 is an elevation view of an exemplary outer layer according to another aspect.
Figure 38 is a cross-sectional view of an exemplary elongated tube taken along line AA in Figure 37 .
Figure 39 is a cross-sectional view of an exemplary outer layer in a resting (non-expanded) configuration, taken along section line BB in Figure 37 .
Figure 40 is a partial cross-sectional view of an exemplary outer layer in one aspect.
FIG. 41 is a cross-sectional view of another exemplary outer layer in a resting (non-expanded) configuration, including a single reinforcing member, taken along section line BB in FIG. 37 .
Figures 42A-42C show an exemplary sheath with a two-layer configuration in one aspect .
Figures 43A-43B show an exemplary sheath with at least one bonding site on the inner surface of the outer layer in one aspect.
Figure 44 is a side elevation view of an exemplary sheath with a proximal section and a tip section in an unexpanded configuration.
Figure 45 is a perspective view of the tip section of the sheath of Figure 44 in an unexpanded configuration.
Figure 46 is another perspective view of the exemplary sheath of Figure 44 with the tip section in an expanded configuration.
Figure 47 is a side elevation view of the tip section of the sheath of Figure 44 in a split configuration.
Figure 48 is a perspective view of the tip section of the sheath of Figure 44 in a split configuration.
Figure 49 is a top view of the inner liner layer with cuts to form a tip section.
Figure 50 is a perspective view of the inner liner layer of Figure 49 in a rolled configuration.
Figure 51 is a top plan view of the inner liner layer of Figure 50 .
Figure 52 is an enlarged view of a portion of the inner liner layer of Figure 51 .
Figure 53 is a top view of the inner liner layer with additional sections removed for shaping of the tip section.
Figure 54 is a side elevation view of a rolled inner liner layer in another aspect with a partially molded distal tip section.
Figure 55 is a perspective view of the distal tip section of Figure 54 .
Figure 56 is a top plan view of the distal tip section of Figure 54 .
Figure 57 is an enlarged view of a portion of Figure 56 .
Figure 58 is a side elevation view of the distal tip section of Figure 54 , receiving an intermediate layer for further shaping the distal tip section.
Figure 59 is a side elevation view of the distal tip section of Figure 58 further assembled.
Figure 60 is a perspective view of the distal tip section of Figure 59 with an intermediate layer formed, for example, by flow melting.
Figure 61 is a side elevation view of the distal tip section of Figure 60 .
Figure 62 is a top plan view of the distal tip section of Figure 60 .
Figure 63 is a schematic diagram of a method of assembly for a distal tip section of an expandable delivery sheath in another aspect of the invention, including the steps of rolling and scoring an inner liner layer.
Figure 64 is a schematic diagram of a method of assembly including placing an intermediate tie layer on a molded inner liner and incorporating a radiopaque marker in the distal tip section.
Figure 65 is a schematic diagram of an assembly method including additional shaping steps of the middle layer of the distal tip section.
Figure 66 is a side elevation view of the distal tip section of an expandable delivery sheath in another aspect.
Figure 67 is a side elevation view of an inner layer with a middle layer at least partially molded into the distal tip section.
Figure 68 is a cross-sectional view of a tube for forming an intermediate layer in another embodiment.
Figure 69 is a cross-sectional view of a tube for forming an intermediate layer with three sub-layers in another embodiment.

The present disclosure may be more readily understood by reference to the following detailed description, examples, drawings, and claims, and their preceding and subsequent descriptions. However, before the articles, systems and/or methods are disclosed and described, it should be noted that the present disclosure is not limited to specific or exemplary embodiments of the disclosed articles, systems and/or methods, unless otherwise specified, and of course, modifications may be made therefrom. You must understand that you can. Additionally, it should be understood that the terminology used herein is merely to describe the embodiments and is not intended to be limiting.

The following description of the disclosure is provided as a possible teaching of the disclosure in its best known form. To this end, those skilled in the art will recognize and understand that many changes may be made to the various aspects of the disclosure described herein while still obtaining beneficial results thereof. Additionally, it will be apparent that some of the desirable advantages of the present disclosure may be obtained by selecting some of the features of the present disclosure without using other features. Accordingly, those skilled in the art will recognize that many modifications and applications of the present disclosure are possible and may even be desirable in certain circumstances, and are part of this disclosure. Accordingly, the following description is provided as illustrative of the principles of the disclosure and not as limiting.

Justice

As used in this application and the claims, the singular forms include the plural unless the context clearly dictates otherwise. Thus, for example, reference to a “polymer” includes embodiments having two or more such polymers unless the context clearly indicates otherwise.

Additionally, it should be understood that the terminology used herein is merely to describe the embodiments and is not intended to be limiting. As used in this specification and claims, the term “comprising” may include “consisting of” and “consisting essentially of” aspects. Additionally, the term “comprising” means “including.”

The terms “for example” and “for example” and their grammatical equivalents should be understood to be followed by the phrase “and without limitation” unless explicitly stated otherwise.

References herein and conclusive claims regarding the weight of a particular element or component within a composition or article refer to the weight relationship between the element or component and any other element or component within the composition or article for which that weight is expressed. indicates. Accordingly, in the composition or selected portion of the composition, a composition containing X and Y with 2 parts by weight of component It exists in this ratio.

Conversely, unless specifically stated, weight percentages of ingredients are based on the total weight of the formulation or composition in which they are included.

Ranges can be expressed herein as “about” one particular value and/or from “about” another particular value. When such ranges are expressed, different aspects include one particular value and/or the other particular value. Similarly, when a value is expressed as an approximation, it will be understood by the preceding use of “about” that that particular value forms another aspect. It should be further understood that the endpoint of each range is significant both in relation to and independently of the other endpoints.

Throughout this disclosure, various aspects of the invention may be presented in range format. It is to be understood that descriptions in range format are for convenience and brevity only and should not be construed as inflexible limitations on the scope of the invention. Accordingly, a description of a range should be considered to specifically disclose all possible subranges as well as individual values within that range. For example, a description of a range such as 1 to 6 describes subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., as well as the individual numbers within that range, e.g. For example, 1, 2, 2.7, 3, 4, 5, 5.3, 6 and any full or partial increments therebetween shall be considered as specifically disclosed. This applies regardless of the width of the scope.

As used herein, the term "substantially" when used in reference to a composition means at least about 80% by weight, at least about 85% by weight, at least about 90% by weight, based on the total weight of the composition of the particular feature or component. At least about 91% by weight, at least about 92% by weight, at least about 93% by weight, at least about 94% by weight, at least about 95% by weight, at least about 96% by weight, at least about 97% by weight, at least about 98% by weight, at least about Refers to 99% by weight, or about 100% by weight.

As used herein, the term “substantially”, e.g., “substantially” in the context “substantially free,” means less than about 1% by weight of the referenced material, e.g., about refers to less than 0.5 weight percent, less than about 0.1 weight percent, less than about 0.05 weight percent, or less than about 0.01 weight percent of the composition.

As used herein, the term “substantially identical reference composition” or “substantially identical reference article” refers to a reference composition or article comprising substantially the same ingredients in the absence of the ingredients of the invention. In another exemplary embodiment, the term “substantially”, e.g., “substantially” in the context “substantially identical reference composition” refers to a reference composition comprising substantially the same ingredients, including components of the present invention. is replaced with a common ingredient in the art.

Additionally, the terms “coupled” and “associated” generally mean coupled or connected electrically, electromagnetically, and/or physically (e.g., mechanically or chemically), coupled or associated. The existence of intermediate elements between items is not excluded.

As used herein, the term “atraumatic” is generally known in the art and refers to a device or procedure that minimizes tissue damage.

As used herein, the term or phrase "effective", "effective amount", or "conditions effective for" refers to the amount or condition under which the effective amount or condition is capable of performing the function or characteristic for which it is expressed. As noted below, the precise amounts or specific conditions required will vary from one embodiment to another depending on recognized variables such as the materials used and the treatment conditions observed. Therefore, it is not always possible to specify the exact “effective amount” or “conditions effective for”. However, an appropriate effective amount will be readily determined by one of ordinary skill in the art using no more than routine experimentation.

Although the operation of example aspects of the disclosed methods may be described in a specific sequential order for convenient presentation, it should be understood that the disclosed aspects may include orders of operation other than the specific sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed simultaneously. Additionally, descriptions and disclosures provided with respect to one particular embodiment are not limited to that embodiment and may apply to any embodiment disclosed.

Additionally, for simplicity, the accompanying drawings do not represent the various ways in which the disclosed systems, methods and devices may be used in combination with other systems, methods and devices, as will be readily discernible to those skilled in the art based on this disclosure. You can. Additionally, the description sometimes uses terms such as “produce” or “provide” to describe the disclosed methods. These terms can be a high-level idea of the actual operation being performed. The actual operations corresponding to these terms may vary depending on the specific embodiment and can be easily discerned by a person skilled in the art, based on this disclosure.

Sis

Disclosed herein is one aspect of a sheath for delivering a medical device, the sheath having a proximal and distal end, and a) an interior defining a lumen having a first resting diameter ( d _r ) and a second expanded diameter ( d _e ). A liner, wherein the lumen is configured to receive and pass a medical device, the inner liner comprising a sheet comprising a first portion having a first surface and an opposing second surface, the first end of the first portion having: divided into a first segment having a first surface and an opposing second surface, and a third segment having a first surface and an opposing second surface, wherein the second end of the first portion is divided into a first segment and an opposing second surface. extending into a second segment having a surface, wherein the sheet is rolled in a helical configuration such that at least a portion of the first surface of the second segment overlaps at least a portion of the second surface of the first segment, At least a portion of the surface overlaps with at least a portion of the second surface of the second segment, at least a portion of the first surface of the third segment overlaps with at least a portion of the second surface of the first segment, and the first The first surface of the portion extends into the first surfaces of the first segment, the second segment and the third segment, and the second surface of the first portion extends into the second surfaces of the second and third segments; wherein each segment is configured to slide along one another as the medical device passes through the lumen; The sheet includes an inner liner comprising a polymer layer; and an outer layer.

In certain embodiments, the resting diameter d _r can be substantially uniform along the longitudinal axis of the lumen. In another aspect, the resting diameter ( d _r ) varies along the longitudinal axis of the lumen, where the resting diameter ( d _r ) at the proximal end is greater than the resting diameter ( d _r" ) at the distal end. One disclosed aspect In another embodiment, the expanded diameter ( d _e ) is configured to receive a medical device passing through the lumen. In another aspect, the sheath may be retracted to a predetermined resting diameter ( d _r ) after passage of the medical device through the lumen.

In one disclosed aspect, the sheet of sheath comprises high density polyethylene, polypropylene, polyamide, fluoropolymer, copolymers thereof, or combinations thereof. In another aspect, the sheet may have a multilayer structure. In another aspect, the interior surface of the sheet is at least partially ribbed.

In one exemplary aspect, the sheet is lubricious and has a coefficient of friction of less than about 0.5.

In another aspect, an amount of first lubricant is disposed between at least a portion of the inner liner and at least a portion of the outer layer. In another disclosed aspect, an amount of second lubricant can be disposed between at least a portion of the overlying portion of the seat and at least a portion of the sliding portion of the seat.

In another disclosed aspect, the outer surface of the elastomeric polymer layer can define at least a portion of the outer surface of the outer layer. In some of the disclosed aspects, at least a portion of the interior surface of the layer of elastomeric polymer is at least partially bonded to at least a portion of the exterior surface of the sheet of the inner liner. In another aspect, at least a portion of the interior surface of the layer of elastomeric polymer may define at least a portion of the interior surface of the outer layer. In another aspect, at least a portion of the braid or coil may define at least a portion of the interior surface of the outer layer.

In one aspect, the sheath comprises a first sheath of elastomeric polymer disposed along at least a portion of the longitudinal axis of the lumen between at least a portion of the outer surface of the sheet, not including the overlapping portion of the sheet, and the inner surface of the outer layer. Additional strips may be included. In another aspect, the sheath can further include a second strip of elastomeric polymer disposed between at least a portion of the outer surface of the sheet and the inner surface of the outer layer at the proximal end of the sheath. In another aspect, the sheath can further include a third strip of elastomeric polymer disposed between at least a portion of the outer surface of the sheet and the inner surface of the outer layer at the distal end of the sheath.

In another aspect, the braid or coil is an expandable braid or coil. In another aspect, the braid or coil may include at least one filament comprising stainless steel, nitinol, polymeric material, or composite material. In certain aspects, the at least one filament may be a round filament or a flat filament. In embodiments where at least one filament includes a polymeric material, the polymeric material may be polyester or nylon. In embodiments where at least one filament is round, the filaments may have a diameter of less than about 0.015". In embodiments where at least one filament is flat, the flat filaments may have a height of less than about 0.006" and a height of about 0.003" to greater than about 0.015". It can have width. In another aspect, the braid can have a coefficient of intersection per inch (PIC) of less than 50. In another aspect, the PIC of the braid may vary along the longitudinal axis of the lumen.

In another embodiment where the at least one filament is nitinol, the nitinol is heat set at d _e . In another embodiment where the at least one filament comprises stainless steel or nitinol, the filament can be configured to be atraumatic at least at the distal end of the sheath.

In another embodiment, the elastomeric polymer present in the outer layer includes styrenic elastomers, polyurethanes, latex, copolymers thereof, blends thereof, or coextrudates thereof. In one aspect, the elastomeric polymer exhibits a Shore A hardness of less than 90. In certain embodiments, the braid or coil may be at least partially embedded within at least a portion of the layer of elastomeric polymer. Additionally, in another aspect, the hydrophilic coating layer can be disposed on the outer surface of the outer layer.

Also disclosed herein are aspects including methods of making a sheath having proximal and distal ends. In certain aspects, a method of making such a sheath includes rolling a sheet having a first edge and a second edge to form a variable diameter inner liner, wherein at least a portion of the inner surface of the sheet has defined by an inner surface and an outer surface in a helical configuration so as to overlap at least a portion of the outer surface to form an overlapping portion, a first edge of the sheet being slidable along at least a portion of the inner surface of the sheet, and a second edge is capable of sliding along at least a portion of the outer surface of the sheet, the inner surface of the sheet defining a lumen of the sheath having a longitudinal axis; forming an outer layer having an inner surface and an outer surface and extending around at least a portion of the variable diameter inner liner such that the inner surface of the outer layer is positioned adjacent the outer surface of the inner liner, wherein the outer layer has: a braid or coil; and comprising an elastomeric layer having a predetermined thickness and having an inner surface and an outer surface; wherein the variable diameter inner liner is configured to slide onto a first edge of the sheet along at least a portion of the inner surface and at least a portion of the outer surface during application of a radially outward force by passage of the medical device through the lumen of the inner liner. It is configured to expand from a predetermined resting diameter d _r to an expanded diameter d _e by sliding along the second edge of the sheet.

In some exemplary embodiments, forming the variable inner liner includes wrapping the sheet over a mandrel having a predetermined diameter to form a helical configuration, wherein the predetermined diameter of the mandrel is equal to the predetermined diameter of the inner liner ( d _r ). is substantially the same as In another aspect, the resting diameter ( d _r ) is substantially uniform along the longitudinal axis of the lumen. In another aspect, the rest diameter ( d _r ) varies along the longitudinal axis of the lumen, where the rest diameter ( d _r ) at the proximal end is greater than the rest diameter (d r") at the distal end. In another aspect, the rest diameter ( d _r ) varies along the longitudinal axis of the lumen. , the expanded diameter ( d _e ) of the sheath is configured to receive a medical device passing through the lumen. In another aspect, the sheath formed by the method disclosed herein has a predetermined resting diameter ( d _r) after passage of the medical device through the lumen. ) can be contracted.

In another aspect, forming the outer layer includes mounting a braid or coil on the inner liner. In another aspect, forming the outer layer further includes mounting the elastomeric polymer onto the braid or coil. In some exemplary embodiments, the methods disclosed herein may further include at least partially embedding the braid or coil within at least a portion of the layer of elastomeric polymer. In another exemplary embodiment, forming the outer layer includes mounting a layer of elastomeric polymer on a braid or coil, and then mounting the layer of elastomeric polymer and braid or coil on an inner liner positioned on a mandrel. It may include a mounting step. In this exemplary aspect, the method may further include at least partially embedding the braid or coil within at least a portion of the layer of elastomeric polymer prior to mounting on the inner liner. Meanwhile, in another aspect, the method may further include, after mounting on the inner liner, at least partially embedding the braid or coil within at least a portion of the layer of elastomeric polymer. In another aspect, the sheath is removed from the mandrel after the outer layer is mounted on the inner liner and bonding is complete.

In another aspect of the method disclosed herein, the outer surface of the elastomeric polymer layer can define at least a portion of the outer surface of the outer layer. However, in other aspects of the methods disclosed herein, at least a portion of the interior surface of the elastomeric polymer layer may define at least a portion of the interior surface of the outer layer. Further disclosed herein are aspects in which at least a portion of the braid or coil may define at least a portion of the interior surface of the outer layer.

In some of certain aspects, the methods disclosed herein further include bonding at least a portion of the interior surface of the layer of elastomeric polymer to at least a portion of the exterior surface of the sheet of the inner liner. In one aspect, the bonding step is performed by heating at a temperature of about 350°F to about 550°F for a time effective to form a bond between at least a portion of the outer layer and at least a portion of the inner liner.

One aspect of the method described herein includes forming a sheet that does not include an overlapping portion prior to or during the step of bonding at least a portion of the inner surface of the elastomeric polymer layer to at least a portion of the outer surface of the sheet of the inner liner. and a first strip of elastomeric polymer applied along at least a portion of the longitudinal axis of the lumen to at least a portion of the exterior surface. In another aspect, before or during the step of bonding at least a portion of the inner surface of the elastomeric polymer layer to at least a portion of the outer surface of the sheet of the inner liner, a second strip of elastomeric polymer is formed at the proximal end of the sheath. It may be applied to at least a portion of the outer surface of the sheet. In another aspect, prior to or during the step of bonding at least a portion of the inner surface of the elastomeric polymer layer to at least a portion of the outer surface of the sheet of inner liner, a third strip of elastomeric polymer is formed at the distal end of the sheath. It may be applied to at least a portion of the outer surface of the sheet.

In another aspect and as described herein, an amount of the first lubricant prior to forming the outer layer such that the amount of the first lubricant is disposed between at least a portion of the outer liner and at least a portion of the inner liner within the sheath. This can be applied to at least a portion of the inner liner. In another aspect, an amount of the second lubricant is applied to at least a portion of the sliding portion and the overlapping portion of the sheet prior to forming the outer layer.

In other aspects of the methods described herein, the sheet may comprise high density polyethylene, polypropylene, polyamide, fluoropolymer, copolymers thereof, or combinations thereof. In another aspect, the sheet may have a multilayer structure. In another aspect, the interior surface of the sheet may be at least partially ribbed. In another aspect, the sheet may be lubricious and have a coefficient of friction of less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, or less than about 0.1.

In another aspect, the method disclosed herein includes a braid or coil, wherein the braid or coil is an expandable braid or coil. In another aspect, the braid or coil of the disclosed method may include at least one filament comprising stainless steel, nitinol, polymeric material, or composite material. In certain aspects, at least one of the filaments may be a round filament or a flat filament. In certain embodiments, the polymeric material present within the braid may be polyester or nylon. In embodiments where the at least one filament is a round filament, such filaments may have a diameter of less than about 0.015". In yet another embodiment where the at least one filament is a flat filament, such filaments may have a height of less than about 0.006" and a length of about Including example values of 0.004", about 0.005", about 0.006", about 0.007", about 0.008", about 0.009", about 0.010", about 0.011", about 0.012", about 0.013", and about 0.014". , may have a width of greater than about 0.003" to about 0.015". In aspects of the methods disclosed herein, the braid may have a coefficient of intersection per inch (PIC) of less than 50, less than 45, less than 40, or even less than 35. In another exemplary aspect, the PIC may vary along the longitudinal axis of the lumen.

In embodiments where at least one filament includes nitinol, the nitinol is heat set at d _e . In aspects where the at least one filament comprises stainless steel or nitinol, the filament is configured to be atraumatic at least at the distal end of the sheath.

In yet a further aspect, the methods disclosed herein include elastomeric polymers, including styrenic elastomers, polyurethanes, latex, copolymers thereof, blends thereof, or coextrudates thereof. In yet a further aspect, the elastomeric polymer may exhibit a Shore A hardness of less than 90. In another aspect, the method may further include disposing a hydrophilic coating layer on the outer surface of the elastomeric polymer layer.

In some methods, the soft tip portion may be coupled to the distal end of the expandable sheath to facilitate passage of the expandable sheath through the patient's vascular system.

Disclosed aspects of the expandable sheath can minimize trauma to the blood vessel by temporarily expanding a portion of the introducer sheath to accommodate the delivery system after passage of the device and then returning it to its original diameter. Some embodiments may include a sheath having a smaller profile (eg, smaller diameter in the resting configuration) than the profile of the prior art introducer sheath. Additionally, this embodiment may not only reduce the time required for the procedure, but also reduce the risk of longitudinal or radial vessel rupture, or plaque dislodgement, since only one sheath is needed, rather than several differently sized sheaths. You can. Embodiments of the present expandable sheath may avoid the need for multiple inserts to expand blood vessels. Such expandable sheaths may be useful for many types of minimally invasive surgery, such as any surgery that requires introduction of a device into a subject's blood vessels. For example, sheaths can be used to transport various types of intraluminal devices (e.g., stents, prosthetic heart valves, stent grafts, etc.) into many types of vascular and non-vascular body cavities (e.g., veins, arteries, esophagus, biliary tract, etc.). It can be used to introduce other types of delivery devices for placement in the biliary tract, intestines, urethral tract, fallopian tubes, other endocrine or exocrine ducts, etc.

Figure 1 shows a sheath 8 according to the invention when used with a representative delivery device 10 for delivering a prosthetic device 12 , such as a tissue heart valve, to a patient. The delivery device 10 includes a steerable guide catheter 14 (also called a flex catheter), a balloon catheter 16 extending through the guide catheter 14 , and a nose catheter 18 extending through the balloon catheter 16 . It can be included. The guide catheter 14 , balloon catheter 16 , and nose catheter 18 in the depicted embodiment facilitate delivery and positioning of the valve 12 at the implantation site within the patient's body, as described in detail below. They are configured to slide longitudinally relative to each other in order to do so. Typically, the sheath 8 is inserted into a blood vessel, such as a transfemoral vessel passing through the patient's skin, such that the distal end of the sheath 8 is inserted into the blood vessel. The sheath 8 may include a hemostat at the opposing proximal end of the sheath. Delivery device 10 can be inserted into sheath 8 and then prosthetic device 12 can be delivered and implanted within the patient.

Figures 2A and 2B show cross-sectional side views of two exemplary sheaths disclosed herein for use with a delivery device such as that shown in Figure 1 . Figure 2C shows a perspective view of one aspect of an inner liner 202 for use with the disclosed sheath. 2A-2C , in some aspects, the disclosed sheath includes an inner liner 202 rolled into a helical configuration such that at least a portion of the interior surface of the sheet overlaps at least a portion of the exterior surface of the sheet, Forming an overlapping portion 202c , wherein a first edge 202a of the sheet is slidable along at least a portion of the interior surface of the sheet and a second edge 202b is slidable along at least a portion of the exterior surface of the sheet. You can slide along. As shown in Figures 2A and 2B , the sheath may further include an outer layer comprising braids (or coils) 204 and a layer of elastomeric polymer 206 . In one aspect, and as shown in Figure 2A , the outer layer may include braids (or coils) 204 that are not embedded in a layer of elastomeric polymer 206 . Meanwhile, in another aspect, and as shown in Figure 2B , the outer layer may include braids (or coils) 204 embedded in a layer of elastomeric polymer 206 .

The inner liner 202 defines a lumen 201 through which the delivery device can be moved into the patient's blood vessel to deliver, remove, repair and/or replace the prosthetic device. The disclosed sheath may also be useful in other types of minimally invasive surgery, such as any surgery that requires introduction of a device into a subject's blood vessel. For example, the disclosed sheath may also be used to provide various types of intraluminal devices (e.g., stents, stent grafts, etc.) to many types of vascular and non-vascular body cavities (e.g., veins, arteries, esophagus, bile ducts of the biliary system, It can be used to introduce other types of delivery devices for placement in the intestines, ureteral tract, fallopian tubes, other endocrine or exocrine tracts, etc.

In another aspect, the sheet used to make inner liner 202 may include high density polyethylene, polypropylene, polyamide, fluoropolymer, copolymers thereof, or blends thereof. In another aspect, the sheet may include one or more layers. In some embodiments, when more than one layer is present, each layer may comprise the same or a different polymer. In another aspect, the sheet may have a predetermined thickness, which may be defined by one of ordinary skill in the art depending on the particular application. In certain embodiments, the predetermined thickness of the inner liner includes exemplary values of about 0.003, about 0.004, about 0.005, about 0.006, about 0.007, about 0.008, about 0.009, about 0.01, about 0.015, and about 0.02 inches. , may be about 0.002 inches to about 0.025 inches. It will further be appreciated that the predetermined thickness of the sheet forming inner liner 202 may vary depending on the strength required as well as the amount of radial expansion desired.

In another aspect, the interior surface of the sheet may be at least partially ribbed. In another aspect, the sheet may also be lubricant. In some exemplary embodiments, the sheet forming the inner liner may have a coefficient of friction of less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, less than about 0.1, or less than about 0.05, or even less than about 0.01. . It will be further understood that the sheet may have a coefficient of friction having any value between any two of the foregoing values. Such a liner can facilitate passage of the delivery device through the lumen 201 of the disclosed sheath. In some further exemplary embodiments, materials that may be used to form a suitable circular inner liner may reduce the coefficient of friction of the inner liner 202 , such as PTFE, polyethylene, polyvinylidine fluoride, and combinations thereof. Contains ingredients that are present. Materials suitable for lubricating liners also preferably have a coefficient of friction of less than about 0.1, less than about 0.09, less than about 0.08, less than about 0.07, less than about 0.05, less than about 0.04, less than about 0.03, less than about 0.02, or less than about 0.01. Includes other materials that have

In another aspect, the outer layer comprising the braid or coil and the layer of elastomeric polymer can have any predetermined thickness. It will be appreciated that the predetermined thickness of the outer layer may vary depending on the particular application of the sheath. For example, and without limitation, inner liner ( 202 ) and the thickness of the outer layer comprising braids (or coils) 204 and a layer of elastomeric material 206 may also vary depending on the particular application of the disclosed sheath. In some embodiments, the thickness of the internal liner 202 is about 0.0006, about 0.0007, about 0.0008, about 0.0009, about 0.001, about 0.002, about 0.003, about 0.004, about 0.005, about 0.007, about 0.008, about 0.009 It ranges from about 0.0005 inches to about 0.010 inches, including example values for inches, and in one particular aspect, the thickness may be about 0.002 inches. The outer layer comprising the braid (or coil) 204 and the layer of elastomeric material 206 may have a thickness of about 0.003, about 0.004, about 0.005, about 0.006, about 0.007, about 0.008, about 0.009, and about 0.01 inches. It may have a thickness from about 0.002 inches to about 0.015 inches, including exemplary values.

It is understood that the inner liner can have any shape or configuration depending on the desired application and size of the delivery device and prosthetic device. It will be further understood that the inner liner is not limited to a particular shape or configuration. In another aspect, the outer layer comprising braids or coils and the layer of elastomeric polymer can conform to the shape or configuration of the inner liner. In certain embodiments, the sheath disclosed herein is defined by a resting diameter ( d _r ) and an outer diameter ( d _o ). As disclosed herein, the resting diameter ( d _r ) may be defined by the inner liner, while the outer diameter may be defined by the inner liner and the outer layer, where the outer layer is a layer of braids or coils and an elastomeric polymer. Includes.

The resting diameter ( d _r ) of the inner liner 202 may vary depending on the application and size of the delivery device and prosthetic device. Figures 3A-3C show various configurations and shapes of inner liners. In some embodiments, and as shown in FIG. 3B , the resting diameter d _r does not vary from the proximal end 308 to the distal end 306 and is substantially uniform along the longitudinal axis of the lumen. In another aspect, and as shown in Figures 3A and 3C , the resting diameter ( d _r ) can vary along the longitudinal axis of the lumen (e.g., d _r1 , as shown in Figure 3 A , and d _r2 , or, as shown in FIG. 3C , d _r1 , d _r2 , d _r3 , and d _r4 ). In certain embodiments, the resting diameter ( dr1 ) at the proximal end ( 304 or 312 ) is the resting diameter ( dr2 ) as shown in Figure 3A , or _the resting diameter ( _{dr )} at the distal end ( 302 or 310 ). , larger than d _r4 as shown in Figure 3c . In another embodiment where the outer layer conforms to the shape of the inner liner, the outer diameter d _o (not shown) includes the overall diameter of the inner liner and outer layer. In this embodiment, the outer diameter ( d _o ) is defined by the specific application of the sheath. Similar to the resting diameter ( d _r ), the non-expanded sheaths disclosed herein The outer diameter d _o may be substantially uniform (invariant) along the longitudinal axis of the lumen without varying from the proximal end to the distal end (not shown). In an alternative embodiment, the original unexpanded outer diameter ( d _o ) of the disclosed sheath may decrease from the proximal end to the distal end, similar to the resting diameter ( d _r ). In some aspects, and similar to the resting diameter ( d _r ), the original unexpanded outer diameter may be reduced along a gradient from the proximal end to the distal end; This can be progressively stepped down along the length of the sheath, where the largest original unexpanded outer diameter ( d _o ) is near the proximal end and the smallest original unexpanded outer diameter ( d _o ) is near the distal end. there is.

In some embodiments, the resting diameter ( d _r ) is about 0.01, about 0.02, about 0.03, about 0.04, about 0.05, about 0.06, about 0.07, about 0.08, about 0.09, about 0.1, about 0.2, and about 0.3 inches. It may range from about 0.005 inches to about 0.400 inches, including example values. As noted above, in certain embodiments, the sheath may include an inner liner having varying d _r . In this aspect, d _r may have any value between any two of the preceding values and may vary depending on the specific application and size and shape of the delivery device and prosthetic device. Depending on the size requirements of the delivery device for various applications, different sheaths may be provided with different expanded and unexpanded rest diameters ( d _r ) and outer diameters ( d _o ). Additionally, some aspects may be provided with greater or lesser extensions depending on the specific design parameters, materials, and/or configurations used.

As disclosed herein, the outer layer of the sheath has an inner surface and an outer surface. The outer layer of the disclosed sheath extends around at least a portion of the variable diameter inner liner such that the inner surface of the outer layer is positioned adjacent the outer surface of the inner liner. As disclosed herein, the outer layer is a braid (or coil) 204 (as shown in FIGS. 2A and 2B ) of an elastomeric polymer 206 having a predetermined thickness and having an inner surface and an outer surface. Includes layers. In certain aspects, the braid or coil may be an expandable braid or coil. In yet a further aspect, the braid or coil may include at least one filament comprising stainless steel, nitinol, polymeric material, or composite material. In certain non-limiting aspects, the braid or coil includes filaments comprising nitinol and/or other shape memory alloys. In another non-limiting aspect, the braid may have filaments comprising polyester or nylon. In another exemplary embodiment, the braid may include filaments comprising spectral fibers, polyethylene fibers, aramid fibers, or combinations thereof.

It is understood that the braid or coil may have any configuration known in the art. In certain embodiments, the braid (or coil) 204 is generally a thin, hollow, substantially cylindrical tube comprising an arrangement, pattern, structure or configuration of filaments or struts, although other geometries may also be used. there is. Suitable filaments are circular, having a diameter of less than about 0.015", less than about 0.01", less than about 0.008", less than about 0.005", less than about 0.002", less than about 0.001", less than about 0.0008", or less than about 0.0005". It can be. In another aspect, a suitable filament may be circular and have a shape of about 0.0006", about 0.0007", about 0.0008", about 0.0009", about 0.001", about 0.002", about 0.003", about 0.004", about 0.005", about From about 0.0005" inch thick to about 0.015" thick, including example values of 0.006", about 0.007", about 0.008", about 0.009", about 0.01", about 0.012", about 0.013", and about 0.014". In another embodiment, suitable filaments may have diameters of less than about 0.006", less than about 0.005", less than about 0.004", less than about 0.003", less than about 0.001", less than about 0.0009", less than about 0.0008". , less than about 0.0007", less than about 0.0006", and about 0.0005". In another aspect, the flat filaments may have a height of about 0.004", about 0.005", about 0.006", about 0.007", about may have a width greater than about 0.003" to about 0.015", including exemplary values of 0.008", about 0.009", about 0.01", about 0.012", about 0.013", and about 0.014". However, other geometries The structure and dimensions are also suitable for specific embodiments.

In further aspects, the braid may have a coefficient of intersection per inch (PIC) of less than 50, less than 40, less than 30, less than 20, or less than 10. In another aspect, the braid may have a PIC coefficient of 10 to 2, with example values of 9, 8, 7, 6, 5, 4, and 3. In yet a further aspect, the PIC may vary along the longitudinal axis of the lumen. In another aspect, the braid pattern can vary along the longitudinal axis of the lumen. In embodiments where the braid or coil includes filaments that are nitinol, the nitinol is heat set at the expanded diameter ( d _e ). In another embodiment where the filament comprises stainless steel or nitinol, the filament is configured to be atraumatic at least at the distal end of the sheath. Figures 4a-4d show partial elevation views of various structures for the braid 28 . It is understood that the structure of the braid 28 varies along the length of the sheath and may vary from section to section. 4A-4D are not necessarily drawn to scale and represent illustrative and non-limiting embodiments only. It is further understood that the braid is configured to provide torque of the sheath during insertion of the prosthetic device.

The outer layer includes a layer of elastomeric polymer 206 , as shown in FIGS. 2A and 2B . In certain embodiments, the elastomeric polymer may include styrenic elastomers, polyurethanes, latex, copolymers thereof, blends thereof, or coextrudates thereof. In certain and non-limiting embodiments, the elastomeric polymer may include polyether block ester copolymers, polyesters, polyvinyl chloride, thermoset silicones, poly-isoprene rubber, polyolefins, other medical grade polymers, or combinations thereof. there is. In another aspect, the elastomeric polymers described herein can have any useful additives. In certain aspects, the elastomeric polymer may include at least one friction reducing additive. In some exemplary embodiments, friction reducing additives may include, for example, BaSO ₄ , ProPell ^™ , PTFE, any combinations thereof, etc. This list of friction reducing additives is not limiting, and it will be understood that any friction reducing additive known in the art may be used.

It will be appreciated that the hardness of each layer of the disclosed sheath may also vary depending on the particular application and desired properties of the sheath. In some embodiments, the layer of elastomeric polymer 206 has a Shore hardness of less than 90 hardness, less than 80 hardness, less than 70 hardness, less than 60 hardness, less than 50 hardness, less than 40 hardness, less than 30 hardness, or less than 20 hardness. . In another exemplary embodiment, the layer of elastomeric polymer 206 has a hardness of about 30 hardness, about 35 hardness, about 40 hardness, about 45 hardness, about 50 hardness, about 55 hardness, about 60 hardness, about 65 hardness, and about It has a Shore hardness of about 25 hardness to about 75 hardness, including an exemplary value of 70 hardness.

Alternative embodiments of the sheath for introducing prosthetic devices are also described. For example, Figures 5A-5B show cross-sectional views of the inner liners 500A and 500B of the disclosed sheath in non-expanded and expanded configurations ( Figures 5A and 5B , respectively). When introducing the prosthetic device into the inner liner, the first edge 502 and the second edge 504 slide along the inner liner to expand it from the resting diameter d _r to the expanded diameter d _e , thereby forming the inner liner. Shorten the overlapping part ( 506 ) of . The expanded diameter d _e is understood to be configured to receive a medical device passing through the lumen. In a further aspect, the sheath retracts to a predetermined resting diameter ( d _r ) following passage of the medical device through the lumen.

In certain embodiments, an amount of first lubricant is disposed between at least a portion of the inner liner and at least a portion of the outer layer. In another aspect, the amount of second lubricant is disposed between at least a portion of the overlying portion of the seat and at least a portion of the sliding portion of the seat. It will be appreciated that the first lubricant and the second lubricant may be the same or different. In certain, and non-limiting, aspects, the first and/or second lubricant may include Christo Lube supplied by ECL or MED10/6670 supplied by Nusil. In another aspect, it will be appreciated that the amount of first and/or second lubricant may be determined as appropriate by one of ordinary skill in the art.

In another aspect, the outer surface of the elastomeric polymer layer defines at least a portion of the outer surface of the outer layer. In another aspect, at least a portion of the interior surface of the layer of elastomeric polymer is at least partially bonded to at least a portion of the exterior surface of the sheet of the inner liner. In one aspect, at least a portion of the interior surface of the layer of elastomeric polymer defines at least a portion of the interior surface of the outer layer. Meanwhile, in another aspect, at least a portion of the braid defines at least a portion of the interior surface of the outer layer. It is understood that the outer layer of the disclosed sheath is configured to provide hemostasis and prevent the patient from bleeding during the procedure.

Figures 6A-6D show another alternative embodiment of a sheath for introducing an artificial device. 6A shows a sheath 600A comprising an inner liner 602 having a first edge 602a and a second edge 602b and an overlapping portion 602c where the inner and outer surfaces of the inner liner overlap each other. do. Sheath 600A further includes a quantity of a second lubricant 608 as disclosed herein disposed between the sliding and overlapping portions of the inner sheath. The sheath further comprises a braid ( 604 ) and a layer of elastomeric polymer ( 606 ). In this exemplary embodiment, braid 604 is not embedded in a layer of elastomeric polymer 606 . Figure 6B shows an alternative embodiment of sheath 600B in which an amount of first lubricant 610 is applied between the inner liner and the outer layer comprising a braid 604 and a layer of elastomeric polymer 606 . Figure 6C shows a further aspect of sheath ( 600C ). In this aspect, sheath 600C includes an inner liner 602 having a first edge 602a and a second edge 602b and an overlapping portion 602c where the inner and outer surfaces of the inner liner overlap each other. . The sheath has braids ( 604 ) that together form the outer layer of the sheath. and a layer of elastomeric polymer ( 606 ). Sheath 600C further comprises a quantity of first lubricant 610 as disclosed herein disposed between the inner liner and the outer layer of the inner sheath. In this exemplary embodiment, braid 604 is not embedded in a layer of elastomeric polymer 606 . In the exemplary embodiment shown in Figure 6D , the exemplary sheath 600D includes a braid 604 embedded within a layer of elastomeric polymer 606 .

In another aspect, the sheath of the present disclosure may include a hemostatic valve within the lumen of the sheath, at or near the proximal end of the sheath. Additionally, exemplary sheaths disclosed herein can include a soft tip at the distal end of the sheath. These soft tips may be provided with lower hardness than other parts of the sheath. In some embodiments, the soft tip is about 26 D, about 27 D, about 28 D, about 29 D, about 30 D, about 31 D, about 32 D, about 33 D, about 34 D, about 35 D, about 36 D. , may have a Shore hardness of about 25 D to about 40 D, including exemplary values of about 37 D, about 38 D, and about 39 D. In another aspect, the soft tip has a length of about 26 A, about 27 A, about 28 A, about 29 A, about 30 A, about 31 A, about 32 A, about 33 A, about 34 A, about 35 A, about 36 A. Shore hardness may be from about 25 A to about 40 A, including exemplary values of A, about 37 A, about 38 A, and about 39 A.

In certain embodiments, the outer layer and inner liner may be bonded together or otherwise physically associated with each other. It will be appreciated that the amount of adhesion between the inner liner 602 and the outer polymer layer comprising the braid 604 and the layer of elastomeric polymer 606 may vary across the surface of the layer. Bonding between layers can be created, for example, by thermal bonding. In certain embodiments, bonding may be facilitated by the presence of additional moieties of the elastomeric polymer. For example, in certain embodiments, a sheath as described herein and shown in Figures 6H-6I comprises at least a portion of the outer surface of the sheet, not including the overlapping portion 602c of the sheet, and the inner surface of the outer layer. and a first strip 611 of elastomeric polymer disposed along at least a portion of the longitudinal axis of the lumen. In this embodiment, bonding between the outer layer and the inner liner may be facilitated by a first strip of elastomeric polymer. In another aspect, the sheath further comprises a second strip 611 of elastomeric polymer ( FIGS. 6E-6F ) disposed between the inner surface of the outer layer and at least a portion of the outer surface of the sheet at the proximal end of the sheath. can do. In another aspect, the sheath may further comprise a third strip 611 of elastomeric polymer disposed between the inner surface of the outer layer and at least a portion of the outer surface of the sheet at the distal end of the sheath ( Figure 6E and 6g ). Again, in this embodiment, bonding between the outer layer and the inner liner may be facilitated by second and/or third strips of elastomeric polymer.

Example applications include about 3 Fr, including exemplary values of about 5 Fr, about 8 Fr, about 10 Fr, about 12 Fr, about 15 Fr, about 18 Fr, about 20 Fr, about 22 Fr, and about 25 Fr. A sheath of the present disclosure can be used having a resting diameter ( d _r ) of the lumen formed by the inner liner ( 602 ) expandable to an expanded diameter ( d _e ) of from about 26 Fr. The expanded diameter may vary along the length of the disclosed sheath. For example, the expanded outer diameter at the proximal end of the sheath is about 5 Fr, about 8 Fr, about 10 Fr, about 12 Fr, about 15 Fr, about 18 Fr, about 20 Fr, about 22 Fr, about 25 Fr. The expanded outer diameter at the distal end of the sheath can range from about 3 Fr to about 28 Fr, inclusive, while the expanded outer diameter at the distal end of the sheath can be about 8 Fr, about 10 Fr, about 12 Fr, about 15 Fr, about 18 Fr, about 20 Fr. Fr, and may range from about 3 Fr to about 25 Fr, including exemplary values of about 22 Fr. The disclosed sheath embodiments include about 15% or more, about 20% or more, about 25% or more, about 30% or more, about 35% or more, about 40% or more, about 45% or more, and about 50% of the original unexpanded outer diameter. greater than about 55%, greater than about 60%, greater than about 65%, greater than about 70%, greater than about 75%, greater than about 80%, greater than about 85%, greater than about 90%, and greater than about 95%. It can be expanded from an expanded outer diameter that is about 10% larger than the original unexpanded outer diameter, including an expanded outer diameter, to an expanded outer diameter that is about 100% larger than the original unexpanded outer diameter.

As mentioned above, it is understood that the disclosed sheath can be extended from its resting position. The expansion of the initiated sheath can result in an expansion of the resting diameter ( d _r ) of about 10% or less to about 430% or more. In certain embodiments, the expansion of the sheath reduces the resting diameter ( d _r ) by less than about 10%, less than about 9%, less than about 8%, less than about 7%, less than about 6%, less than about 5%, less than about 4%. , can be expanded to about 3% or less, about 2% or less, and about 1% or less. In another embodiment, the disclosed expansion of the sheath increases the resting diameter ( d _r ) by at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, and about 70%. or more, about 80% or more, about 90% or more, about 100% or more, about 125% or more, about 150% or more, about 175% or more, about 200% or more, about 225% or more, or about 250% or more. You can.

As with previously disclosed embodiments, the embodiments illustrated in FIGS. 6A-6D can be applied to sheaths with a wide variety of rest diameters ( d _r ) and outer diameters ( d- _o ). In some embodiments, the outer diameter of the sheath gradually decreases from the proximal end of the sheath to the distal end of the sheath. For example, in one aspect, the outer diameter ( d- _o ) may gradually decrease from about 26 Fr at the proximal end to about 18 Fr at the distal end. The diameter ( d _o ) of the sheath may be gradually varied over substantially the entire length of the sheath. In other embodiments, the transition or decrease in the diameter of the sheath may occur only along a portion of the length of the sheath. For example, the transition may occur along the length from the proximal end to the distal end, where the length ranges from about 0.5 inches to about the entire length of the sheath, including any value between any two of the preceding values. It can be. In another aspect, d _o is minimal and constant along the section of the sheath passing through the vasculature. In this aspect, the tapered section is about 4" or less on the proximal side of the sheath.

In some embodiments, the outer layer comprising the braid and the layer of elastomeric polymer may comprise the same material or combination of materials along the entire length. In alternative embodiments, the material composition of the outer layer may vary along the length of the sheath. For example, the outer layer may have one or more segments, where the composition varies from segment to segment. For example, in one segment, the braid may include nitinol with a different PIC coefficient than the other segments. In another exemplary aspect, the layer of elastomeric material within one segment can be different from the layer of elastomeric material within another segment. In another exemplary embodiment, one segment of the sheath may include a braid or coil embedded within a layer of elastomeric polymer material, while the other segment may include a braid or coil that is not embedded within a layer of elastomeric polymer material. may include. It is understood that the exemplary sheaths disclosed herein are not limiting. In certain example embodiments, a sheath may include n segments, where each segment may be the same or different. In another exemplary embodiment, the hardness grade of the composition of the outer layer may also vary along the length of the sheath, such that segments near the proximal end comprise a stiffer material or combination of materials, while segments near the distal end includes softer materials or combinations of materials. This may allow the sheath to have a relatively rigid proximal end at the point of introduction of the delivery device, while still having a relatively soft distal tip at the point of entry into the patient's blood vessel.

10 and 11 illustrate an expandable sheath 100 according to the present invention, which can be used in conjunction with a delivery device to deliver a prosthetic device, such as a tissue heart valve, to a patient. Alternatively, the delivery device may include a steerable guide catheter (also called a flex catheter) and a balloon catheter extending through the guide catheter (e.g., as shown in Figure 1 ). The guide catheter, balloon catheter, and nose catheter may be configured to slide longitudinally relative to each other to facilitate delivery and positioning of the valve at the implantation site within the patient's body. However, it should be noted that sheath 100 can be used with any type of elongated delivery device used to implant balloon-expandable prosthetic valves, self-expandable prosthetic valves, and other prosthetic devices. Alternatively, sheath 100 can be inserted into a blood vessel (e.g., femoral or iliac artery) by passing through the patient's skin, thereby attaching the soft tip portion ( 104 ) at the distal end 104 of sheath 100 102 ) is inserted into the blood vessel. The sheath 100 may also include a proximal flared end portion 114 to facilitate mating with the introducer housing 101 and the catheter described above (e.g., the proximal flared end portion 114 may be positioned in the housing 101 ). A compression fitting may be provided for the tip and/or the proximal flared end portion 114 may be secured to the housing 101 via a nut or other fastening device or by coupling the proximal end of the sheath to the housing. Introducer housing 101 can accommodate one or more valves that, once inserted through the housing, form a seal around the exterior surface of the delivery device, as is known in the art. A delivery device may be inserted within and through sheath 100 , thereby allowing the prosthetic device to be advanced through the patient's vasculature and implanted within the patient.

In an exemplary embodiment, sheath 100 includes an inner liner 108 and an outer layer 110 disposed around inner liner 108 . The outer layer 110 includes a braid (or coil) 111 and a layer of elastomeric polymer 113 . Figure 11 shows one non-limiting embodiment in which the braid (or coil) 111 is embedded in a layer of elastomeric polymer 113 . The inner liner 108 has a resting diameter ( d _r ) that allows the delivery device to be moved within the patient's blood vessel to deliver, remove, repair and/or replace the prosthetic device while moving along the longitudinal axis (X). Define a lumen with . When an artificial device passes through the sheath 100 , the sheath expands locally from a resting diameter ( dr ) to an expanded diameter ( d _e ) to accommodate the artificial device. After the prosthetic device has passed a particular location of sheath 100 , each successively expanded portion or segment of sheath 100 returns at least partially to its resting diameter d _r . In this way, the sheath 100 can be considered self-expanding in that it does not require the use of a balloon, expander, and/or obturator for expansion.

The inner and outer layers 108 , 110 may include any of the materials described above, as indicated herein.

Additionally, in some embodiments, sheath 100 may include an external hydrophilic coating on the outer surface portion of outer layer 110 . This hydrophilic coating can facilitate insertion of the sheath 100 into a patient's blood vessel. Examples of suitable hydrophilic coatings include Harmony ^™ Advanced Lubricity Coating and other Advanced Hydrophilic Coatings available from SurModics, Inc. (Eden Prairie, MN). DSM medical coatings (available from Koninklijke DSM NV, Heerlen, the Netherlands) and other hydrophilic coatings (e.g. PTFE, polyethylene, polyvinylidine fluoride) are also suitable for use in the sheath ( 100 ).

As best visualized in Figure 11 , the soft tip portion 102 may, in some embodiments, comprise low-density polyethylene (LDPE) and protect against trauma or damage to the patient's blood vessels as the sheath is navigated through the vascular system. It can be configured to minimize. For example, in some aspects, the soft tip portion 102 may be slightly tapered to facilitate passage through blood vessels. The soft tip portion 102 may be secured to the distal end 104 of the sheath 100 , such as by thermally bonding the soft tip portion 102 to the inner and outer layers of the sheath 100 . These soft tips 102 may be provided with lower hardness than other parts of the sheath 100 . In some embodiments, the soft tip 102 may have a Shore hardness of about 25 A to about 40 A, including exemplary values of about 28 A, about 30 A, about 32 A, about 35 A, and about 38 A. You can. It will also be understood that Shore hardness can have any value between any two of the preceding values. In another aspect, the soft tip 102 has a Shore hardness of about 25 D to about 40 D, including exemplary values of about 28 D, about 30 D, about 32 D, about 35 D, and about 38 D. You can have it. The tip portion 102 is configured to be radially expandable to allow the prosthetic device to pass through the distal opening of the sheath 100 .

As shown in Figure 11 , sheath 100 optionally has at least one radiopaque filler or marker, such as a discontinuous or C-shaped band 112 positioned near the distal end 104 of sheath 100. It can be included. Marker 112 may be associated with the inner liner and/or outer layer 108, 110 of sheath 100 . Such radiopaque tip markers may include materials such as suitable radiopaque fillers, platinum, iridium, platinum/iridium alloys, stainless steel, other biocompatible metals, or combinations thereof. Materials suitable for use as radiopaque fillers or markers include, for example, barium sulfate, bismuth trioxide, titanium dioxide, bismuth subcarbonate, or combinations thereof. The radiopaque filler may be mixed with or embedded within the layer of elastomeric polymer used to form the outer layer, and may be about 10%, about 15%, about 20%, about 25% by weight of the outer polymer tubular layer. It may comprise from about 5% to about 45% by weight of the outer layer, including exemplary values of weight%, about 30% by weight, about 35% by weight, and about 40% by weight. Depending on the particular application, more or less radiopaque materials may be used in some embodiments.

12A-12B show a cross-sectional view of sheath 100 taken near the distal end 104 of sheath 100 .

FIG. 12A shows a cross-sectional view of an exemplary sheath with lubricant disposed between the sliding and overlapping portions of the sheet and the braid not embedded in the elastomeric polymer layer. More specifically, FIG . 12A shows a sheath ( 1200A ) is shown. Sheath 1200A further includes a quantity of a second lubricant 1208 as disclosed herein disposed between the sliding and overlapping portions of the inner sheath. The sheath further comprises a braid (or coil) 1204 and a layer of elastomeric polymer 1206 . In this exemplary embodiment, the braid (or coil) 1204 is not embedded in a layer of elastomeric polymer 1206 .

FIG. 12B shows a cross-sectional view of an exemplary sheath with a lubricant disposed between the sliding and overlapping portions of the sheet and a lubricant disposed between the inner liner and the outer layer where the braided portion is not embedded in the elastomeric polymer layer. More specifically, FIG. 12B shows a sheath 1200B in which an amount of first lubricant 1210 is applied between the inner liner and the outer layer comprising a braid (or coil) 1204 and a layer of elastomeric polymer 1206 . Shows an alternative form of .

Figure 12C shows a further aspect of sheath 1200C . 12C shows a cross-sectional view of an exemplary sheath with a lubricant disposed between the lubricant disposed between the inner liner and the outer layer of the sheet, wherein the braid is not embedded in the elastomeric polymer layer, with or without lubricant. . More specifically, in this aspect, sheath 1200C includes an inner liner 1202 having a first edge 1202a and a second edge 1202b and an overlapping portion 1202c where the inner and outer surfaces of the inner liner overlap each other. ) includes. The sheath has braids (or coils) that together form the outer layer of the sheath ( 1204 ). and a layer of elastomeric polymer ( 1206 ). Sheath 1200C further comprises a quantity of first lubricant 1210 as disclosed herein disposed between the outer layer and inner liner of the inner sheath. In this exemplary embodiment, the braid (or coil) 1204 is not embedded in a layer of elastomeric polymer 1206 . 12D shows a cross-sectional view of an exemplary sheath with a lubricant disposed between the sliding and overlapping portions of the sheet and a lubricant disposed between the outer layer and the inner liner with the braided portion at least partially embedded in the elastomeric polymer layer. More specifically, in the exemplary embodiment shown in Figure 12D , the exemplary sheath 1200D includes a braid (or coil) 1204 embedded within a layer of elastomeric polymer 1206 .

Figures 13A-D show cross-sectional views of the proximal section of the sheath of Figure 10 , taken along line 38-38.

FIG. 13A shows a cross-sectional view of an exemplary sheath with lubricant disposed between the sliding and overlapping portions of the sheet and the braid not embedded in the elastomeric polymer layer. More specifically, FIG. 13A shows a sheath ( 1300A ) is shown. Sheath 1300A further includes a quantity of second lubricant 1308 as disclosed herein disposed between the sliding and overlapping portions of the inner sheath. The sheath further comprises a braid (or coil) 1304 and a layer of elastomeric polymer 1306 . In this exemplary embodiment, the braid (or coil) 1304 is not embedded in a layer of elastomeric polymer 1306 .

FIG. 13B shows a cross-sectional view of an exemplary sheath with a lubricant disposed between the sliding and overlapping portions of the sheet and a lubricant disposed between the outer layer and the inner liner where the braided portion is not embedded in the elastomeric polymer layer. More specifically, FIG. 13B shows a sheath 1300B in which an amount of first lubricant 1310 is applied between the inner liner and the outer layer comprising a braid (or coil) 1304 and a layer of elastomeric polymer 1306 . Shows an alternative form of . Figure 13C shows a further aspect of sheath 1300C . 13C shows a cross-sectional view of an exemplary sheath with a lubricant disposed between the lubricant disposed between the inner liner and the outer layer of the sheet, wherein the braid is not embedded in the elastomeric polymer layer, with or without lubricant. . More specifically, in this aspect, sheath 1300C includes an inner liner 1302 having a first edge 1302a and a second edge 1302b and an overlapping portion 1302c where the inner and outer surfaces of the inner liner overlap each other. ) includes. The sheath is made up of braids (or coils) that together form the outer layer of the sheath ( 1304 ). and a layer of elastomeric polymer ( 1306 ). Sheath 1300C further comprises a quantity of first lubricant 1310 as disclosed herein disposed between the outer layer and inner liner of the inner sheath. In this exemplary embodiment, the braid (or coil) 1304 is not embedded in a layer of elastomeric polymer 1306 .

13D shows a cross-sectional view of an exemplary sheath with a lubricant disposed between the sliding and overlapping portions of the sheet and a lubricant disposed between the outer layer and the inner liner with the braided portion at least partially embedded in the elastomeric polymer layer. In this exemplary embodiment, sheath 1300D includes a braid (or coil) 1304 embedded within a layer of elastomeric polymer 1306 .

In another embodiment, as shown in Figure 14 , the braid or coil has a braid or coil embedded within a layer of elastomeric polymer (as shown in Figure 14 ) or a braid that is not embedded within a layer of elastomeric polymer. Sheath 1400 with coils is configured to expand from a resting configuration to an expanded configuration shown in FIG. 15 . In this aspect, the first and second edges 1502a and 1502b of the inner liner slide to shorten the length of the overlapping portion. In some example embodiments, such movement may be facilitated by the presence of a first and/or second lubricant, as described above.

The sheath disclosed herein may be configured to expand locally at specific locations corresponding to the location of the medical device along the length of the lumen and then locally retract once the medical device passes that specific location. Accordingly, a bulge may be visible as a medical device is introduced through the sheath and moves longitudinally along the length of the sheath, exhibiting continuous localized expansion and contraction as the device moves the length of the sheath. In some embodiments, each segment of the sheath can locally retract and return to the original resting diameter ( d _r ) of the lumen after removal of any radial outward (insertion) force.

In some embodiments, each segment of the sheath can locally retract after removal of any radial outward force to at least partially return to the original resting diameter ( d _r ) of the lumen.

As shown in FIG. 1 for the delivery of prosthetic device 12 , additional sheath 8 configurations that can be used with delivery device 10 are further disclosed.

For example, and not by way of limitation, Figures 21A-21B illustrate one exemplary aspect of the sheath disclosed herein. In this aspect, the sheath includes a proximal end and a distal end. Sheath 2100 may include a variable diameter inner liner 2102 comprising a sheet having a first edge 2104 and a second edge 2106 and defined by an inner surface 2102a and an outer surface 2102b . is defined. When the sheet is wound in a spiral configuration, at least a portion of the inner surface 2102a of the sheet overlaps at least a portion of the outer surface 2102b of the sheet. As shown in Figures 21A-B , a first edge 2104 of the sheet can slide along at least a portion of the interior surface 2102a of the sheet and a second edge 2106 is slidable along the exterior surface 2102b of the sheet. ) can slide along at least a portion of the. The sheath further includes an outer layer 2108 having an inner surface 2108a and an outer surface 2108b .

The interior surface 2102a of the sheet further defines the lumen of the sheath through which the delivery device can be moved into the patient's blood vessel to deliver, remove, repair, and/or replace the prosthetic device. The disclosed sheath may also be useful in other types of minimally invasive surgery, such as any surgery that requires introduction of a device into a subject's blood vessel. For example, the disclosed sheath may also be used to provide various types of intraluminal devices (e.g., stents, stent grafts, etc.) to many types of vascular and non-vascular body cavities (e.g., veins, arteries, esophagus, bile ducts of the biliary system, It can be used to introduce other types of delivery devices for placement in the intestines, ureteral tract, fallopian tubes, other endocrine or exocrine tracts, etc.

It will be further understood that the sheath may also include additional layers. Some of these additional layers are disclosed in detail below or above. For example, as disclosed in some of the exemplary embodiments described above, the sheath may also include a braid or coil disposed between the inner liner and the outer layer and/or a braid or coil embedded in the outer layer.

In the exemplary embodiment shown in Figures 21A-21B , the sheath does not include braids or coils disposed along the length of the sheath between the inner liner and the outer layer or embedded in the outer layer.

Similar to other aspects of the sheath, the exemplary sheath of FIGS. 21A-21B can have a variety of inner liners depending on the desired application and size of the delivery device and prosthetic device. It will be further understood that the inner liner is not limited to a particular shape or configuration. In certain embodiments, the sheath disclosed herein is defined by a resting diameter ( d _r ) and an outer diameter ( d _o ). As disclosed herein, the resting diameter d _r may be defined by the inner liner, while the outer diameter may be defined by the inner liner and the outer layer.

The resting diameter ( d _r ) of the inner liner 2102 may vary depending on the application and size of the delivery device and prosthetic device. The sheath disclosed herein can have configurations similar to those shown in FIGS . 3A-3C and those described above. In some embodiments, and as shown in Figure 3B , the resting diameter d _r1 does not vary from the proximal end 308 to the distal end 306 and is substantially uniform along the longitudinal axis of the lumen. In another aspect, and as shown in Figures 3A and 3C , the resting diameter ( d _r ) can vary along the longitudinal axis of the lumen (e.g., d _r1 , as shown in Figure 3 A , and d _r2 , or, as shown in FIG. 3C , d _r1 , d _r2 , d _r3 , and d _r4 ). In certain embodiments, the resting diameter ( dr1 ) at the proximal end ( 304 or 312 ) is the resting diameter ( dr2 ) as shown in Figure 3A , or _the resting diameter ( _{dr )} at the distal end ( 302 or 310 ). , larger than d _r4 as shown in Figure 3c . In another embodiment where the outer layer conforms to the shape of the inner liner, the outer diameter d _o (not shown) includes the overall diameter of the inner liner and outer layer. In this embodiment, the outer diameter ( d _o ) is defined by the specific application of the sheath. Similar to the resting diameter ( d _r ), the non-expanded sheaths disclosed herein The outer diameter d _o may be substantially uniform (invariant) along the longitudinal axis of the lumen without varying from the proximal end to the distal end. In an alternative embodiment, the original unexpanded outer diameter ( d _o ) of the disclosed sheath may decrease from the proximal end to the distal end, similar to the resting diameter ( d _r ). In some aspects, and similar to the resting diameter ( d _r ), the original unexpanded outer diameter may be reduced along a gradient from the proximal end to the distal end; This can be progressively stepped down along the length of the sheath, where the largest original unexpanded outer diameter ( d _o ) is near the proximal end and the smallest original unexpanded outer diameter ( d _o ) is near the distal end. there is.

In some embodiments, and similar to other sheath configurations described herein, the resting diameter ( d _r ) of the sheath as shown in Figures 21A-21B can also be about 0.01, about 0.02, about 0.03, about 0.04, about 0.05. , including exemplary values of about 0.06, about 0.07, about 0.08, about 0.09, about 0.1, about 0.2, and about 0.3 inches. As described above, in certain embodiments, the sheath may include an inner liner having various d _r . In this aspect, d _r may have any value between any two of the preceding values and may vary depending on the specific application and size and shape of the delivery device and prosthetic device. Depending on the size requirements of the delivery device for various applications, different sheaths may be provided with different expanded and unexpanded rest diameters ( d _r ) and outer diameters ( d _o ). Additionally, some aspects may be provided with greater or lesser extensions depending on the specific design parameters, materials, and/or configurations used.

Figures 22A-22B illustrate an exemplary method of expanding a sheath, for example as shown in Figures 21A-21B . As shown in FIG. 22A , sheath 2202 changes from a collapsed configuration to an extended configuration 2204 during passage of the medical device by sliding the first and second longitudinal edges along each other and reducing the overlap of the helical configuration. It can be expanded. Again, the expanded diameter d _e may vary depending on the diameter of the medical device passing through it. In another aspect, and as discussed in detail below, the outer layer is configured to impart an inward radial force on the inner liner to retract the sheath to a diameter substantially equal to d _r after the medical device has passed through the lumen. do. It will be further understood that any of the sheath configurations described herein may expand and collapse locally upon passage of a medical device. 22B shows images of sequential moments of sheath expansion during passage of an exemplary medical device.

Additional embodiments of the cis are disclosed in Figures 24A-24B . For example, Figure 24A shows the inner liner of a sheath having a similar configuration to the sheath disclosed in Figure 22 , wherein the first end 2404 and the second end 2406 are oriented along a vertical axis passing through the thickness of the sheath. 2420 ) are substantially aligned in a spaced relationship. In this configuration, a portion of sheet 2403 is positioned between a first edge and a second edge along the vertical axis. As shown in Figure 24A , when inner liner 2402 is in its unexpanded rest state, the inner liner includes at least two layers of sheets overlapping one another along at least a portion of the circumference of the sheath. Additionally, as shown in Figure 24 , the inner liner may include at least two layers of sheets overlapping one another along the entire circumference of the sheath.

Figure 24b shows a different configuration of the liner in the expanded state. For example, when liner 2402 is in an unexpanded resting state, the inner liner may include a portion along the circumference of the sheath, which may have three layers of sheet 2430 .

Returning to FIG. 22A , for example, an inner liner wherein a first edge 2204 is substantially aligned with a vertical axis 2420 passing through the thickness of the sheath and a second edge 2406 is circumferentially offset from the vertical axis. The composition also exists. In this aspect, along at least a portion of the circumference of the sheath, the inner liner comprises one layer of sheeting without any overlapping portions.

Additional configurations of the sheath are also shown in Figures 31-32 . Some of the sheath configurations described above are formed by providing an elongated tube and cutting the tube along its length to form a sheet having a first longitudinal edge and a second longitudinal edge. The sheet is formed by the formation of slits. In various configurations, specific types of slits can be formed depending on the final desired application. For example, for the various sheath configurations disclosed above, as shown in Figure 9A , for example, the slit 905 is substantially straight along the length of the tube forming the inner liner. In this exemplary embodiment, the slit formed during cutting is substantially straight from the proximal end of the inner liner to the distal end of the inner liner. In this aspect, the helical configuration formed when the sheet is wound into a scroll is substantially straight along the length of the sheath.

However, aspects in which the inner liner is wound in a helical scroll configuration are also disclosed herein. Figure 32 shows an example diagram of this configuration. In this aspect, an elongated tube to form the inner liner 915 is provided and cut ( FIG. 31 ) such that a longitudinal slit 911 is formed between the proximal and distal ends of the tube, and the tubular inner liner 915 forming a first longitudinal edge and a second longitudinal edge. As shown in FIG. 31 , for example, the slits in these embodiments are not formed along the longitudinal axis of the liner, but have at least some offset therefrom. The slits are formed such that the inner liner is wound in a helical scroll configuration such that, in the helical scroll configuration, at least a portion of the inner surface of the inner liner 915b helically overlaps with at least a portion of the outer surface 915a of the inner liner. (Overlap is not shown in Figure 31 ). Figure 32 shows overlapping portion 913 . In another aspect, in this helical sheath configuration, a first longitudinal edge of the inner liner can slide along at least a portion of the inner surface of the inner liner and a second longitudinal edge can slide along at least a portion of the outer surface of the inner liner. You can slide along the part.

In this exemplary embodiment, the tubular inner liner further includes helically sliding a first edge of the inner liner along at least a portion of the inner surface while applying a radial outward force by passing a medical device through a lumen of the inner liner. and extending from the resting diameter d _r to the expanded diameter d _e by helically sliding the second edge of the inner liner along at least a portion of the outer surface of the inner liner.

When the sheath is inserted into a patient, for example via the femoral artery, and is passed along the arterial path, which can often be a twisted and tortuous path, the sheath is forced to assume a curved configuration along it. Additionally, when a larger diameter prosthetic valve (or any other prosthetic device that can be advanced through the sheath) is passed through the sheath, the combination of the bending configuration of the sheath and the expansion force creates an undesirable gap between the two longitudinal edges. This can create a layer of sheath that potentially splits the longitudinal edge, which can cause the formation. A sheath with a helical configuration may avoid these potentially undesirable effects. In some aspects, the exemplary helical configuration of the sheath may enable expansion of the inner liner without a substantial gap being formed between the longitudinal edges of the inner liner defined by the slits. In this exemplary aspect, the tubular inner liner of the disclosed sheath is also configured to bend while passing through the patient's native anatomy without forming a gap between the first and second longitudinal edges of the tubular inner liner. .

It is understood that the divisions can be formed in any orientation allowing for a helical configuration of the scroll. For example, and without limitation, in some aspects, the longitudinal slit may extend from a proximal end of the tubular inner liner to a distal end of the tubular inner liner in a direction offset from the longitudinal axis of the tubular inner liner. In another aspect, the direction is diagonal from the proximal end of the tubular inner liner to the distal end of the tubular interior. In another aspect, the longitudinal slit has an angle greater than about 90 degrees, such as about 100 degrees, about 110 degrees, about 120 degrees, about 130 degrees, about 140 degrees, about 150 degrees, about 160 degrees, and about 170 degrees, or tubular at angles less than about 90 degrees, such as about 80 degrees, about 70 degrees, about 60 degrees, about 50 degrees, about 40 degrees, about 30 degrees, about 20 degrees, and about 10 degrees. It extends over the length of the tubular inner liner, from the proximal end of the inner liner to the distal end of the tubular interior.

In another aspect, longitudinal slits may be formed between the proximal end of the tubular inner liner and the distal end of the tubular inner liner in a pattern other than straight. For example, and without limitation, slits may be formed to allow a particular pattern of the sheet to be formed. For example, in this aspect, the first and second longitudinal edges are not substantially straight. In some aspects, the slit can be formed such that each of the first and second longitudinal edges can have a zigzag shape or have an angle greater or less than 180 degrees or 0 degrees. For example, each edge may be protruding and have a corresponding concave shape, or be concave and have a corresponding convex shape, curved shape, etc., depending on the orientation of the slit. Again, it is understood that any orientation of the slits that can form a helical scroll configuration of the inner liner is contemplated and described.

In another aspect, the slits may be formed such that the helical configuration of the inner liner has a predetermined pitch. In certain embodiments, the pitch may be at least about 2, at least about 3, at least about 4, at least about 5, or at least about 6 turns for every 10 cm of sheath.

In another aspect, the resting diameter (d _r ) and expanded diameter (d _e ) of this exemplary sheath can be similar to any of those described in the preceding aspects.

In another aspect, and similar to other sheath configurations, the tubular inner liner having a helical scroll configuration may include high density polyethylene, polypropylene, polyamide, fluoropolymer, copolymers thereof, or blends thereof. In a further aspect, and as disclosed in other configurations, the inner liner can have a multilayer structure. In some aspects, the interior surface of the inner liner can be substantially smooth. In another aspect, the interior surface of the tubular inner liner can be at least partially ribbed. In yet a further aspect, the tubular inner liner can be lubricious and have a coefficient of friction of less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, less than about 0.1.

A further configuration of the sheath is also shown in Figure 33 . In this aspect, variable diameter inner liner 3300 includes a sheet 3302 having a first longitudinal edge 3302a and a second longitudinal edge 3302b . The sheet is wound in a helical configuration, as shown in Figure 33 , such that at least a portion of the inner surface of the sheet overlies at least a portion of the outer surface of the sheet forming an overlap; wherein at least a portion of the outer surface of the sheet adjoining the first longitudinal edge 3302a includes a first plurality of protrusions 3320 . In another aspect, at least a portion of the first plurality of protrusions is disposed within the overlapping portion, thereby reducing the contact area between the inner surface and the outer surface of the sheet within the overlapping portion.

In another aspect, in the disclosed helical configuration of the inner liner, a first longitudinal edge 3302a of the sheet can slide along at least a portion of the interior surface of the sheet, and a second longitudinal edge 3302b can slide along at least a portion of the interior surface of the sheet. It can slide along at least a portion of the outer surface.

However, it is understood that the plurality of protrusions may be present on the inner surface of the sheet in addition to or alternatively to the outer surface. In this aspect (not shown), the second plurality of protrusions 3320 may also be disposed on the interior surface at least abutting the second longitudinal edge 3302b . Additionally, it will be appreciated that the first and second pluralities of protrusions may be the same or different. In this exemplary embodiment, for example, the first and second pluralities of protrusions may have the same composition but different shapes. Other exemplary embodiments including a first and second plurality of protrusions that are different in both composition and shape or that are different in composition and shape are also contemplated.

In another aspect, the interior surface of the sheet defines a lumen of the sheath having a longitudinal axis.

In yet a further aspect, the variable diameter inner liner is configured to slide a first edge of the sheet along at least a portion of the inner surface and the outer surface while applying a radial outward force by passing a medical device through a lumen of the inner liner. and is configured to expand from the first resting diameter d _r to the second expanded diameter d _e by sliding the second edge of the sheet along at least a portion of .

In another aspect, the sheet is rolled to form a spiral with no sections having no more than three predetermined thicknesses in the radial direction and small portions having only one predetermined thickness in the radial direction. In certain embodiments, when the medical device passes through an expandable variable diameter inner liner, the applied radial force is high, and any friction or adhesion between the sliding portions undesirably increases the pressing force.

In another aspect, the sheet has a predetermined thickness. In this aspect, the sheet has a thickness of from about 0.002 inches to about 0.002 inches, including exemplary values of about 0.003, about 0.004, about 0.005, about 0.006, about 0.007, about 0.008, about 0.009, about 0.01, about 0.015, and about 0.02 inches. It can have any thickness from 0.025 inches. It will be further appreciated that the predetermined thickness of the sheet forming the inner liner of any of the configurations described herein may vary depending on the strength required as well as the amount of radial expansion desired.

In another aspect, the first and/or second plurality of protrusions may be disposed on the interior and/or exterior surfaces of the sheet in any possible arrangement or pattern suitable for the desired application. In some aspects, the first and/or second plurality of protrusions can be arranged in a predetermined pattern to reduce the contact area between the inner and outer surfaces of the sheet within the overlapping portion. It is understood that the reduction of contact may be useful during dilatation procedures, as the two parts do not stick together and thus reduce the pressing force required to pass the medical device through the sheath.

In another aspect, the first and/or second plurality of protrusions can have any shape that allows to achieve the desired result. In certain embodiments, the first and/or second plurality of protrusions are of a regular shape, such as continuous stripes along the length of the inner liner, or in a discontinuous pattern, such as discrete circular shaped protrusions, rectangular, diamond-shaped, trapezoidal, etc. may include. In another aspect, the shape may be irregular, for example a star shape or any other shape. In another aspect, the plurality of protrusions may have various combinations of shapes.

In another aspect, the first and/or second plurality of protrusions have an average height of up to about 1%, about 5%, about 10%, about 15%, or up to about 20% of a predetermined thickness of the sheet itself. You can. It will be appreciated that in some aspects, each of the first and/or second plurality of protrusions need not have the same height. In another aspect, the first and/or second plurality of protrusions can have substantially the same height.

In another aspect, the sheet includes a first polymer composition. In this aspect, the first polymer composition may include high density polyethylene, polypropylene, polyamide, fluoropolymer, copolymers thereof, or blends thereof. Meanwhile, in yet a further aspect, the sheet may have a multilayer structure. In embodiments where there is more than one layer, each layer may include the same material or a different material.

In another aspect, the first and/or second plurality of protrusions can comprise a second polymer composition. Again, it will be appreciated that the second polymer composition may be the same or different from the first polymer composition depending on the particular application. Again, it will be appreciated that the first and/or second plurality of protrusions may be disposed on the outer surface and/or the inner surface of the sheet, respectively. In aspects where there are first and second pluralities of protrusions, the second plurality of protrusions present on the interior surface may be the same or different from the first plurality of protrusions present on the exterior surface of the sheet. In embodiments where the second polymer composition differs from the first polymer composition, it is understood that these two compositions are compatible with each other and can be combined together.

In another aspect, it will be appreciated that the portion of the sheet comprising the first and/or second plurality of protrusions is not limited to an overlapping portion.

In some aspects, at least a portion of the sheet having the first and/or second plurality of protrusions can be larger than the overlapping portion. In another aspect, at least a portion having the first and/or second plurality of protrusions is substantially equal to the circumference of the sheet in a helical configuration. In this aspect, it is understood that the first and/or second plurality of protrusions are respectively disposed over the entire outer and/or inner surface of the sheet.

In another aspect, the first and/or second plurality of protrusions may each be disposed on an outer surface and/or an inner surface of the sheet along at least a portion of the length of the sheath. In another aspect, the first and/or second plurality of protrusions may be disposed on the outer surface and/or inner surface of the sheet, respectively, in contact with the distal end of the sheath. In another aspect, the first and/or second plurality of protrusions may be disposed on the outer surface and/or inner surface of the sheet, respectively, in contact with a proximal end of the sheath. In another aspect, the first and/or second plurality of protrusions may be disposed respectively on the outer surface and/or inner surface of the sheet along the entire length of the sheath.

In some example embodiments, the first and/or second plurality of protrusions may have various shapes as described above, and such shapes may be continuous along at least a portion of the length of the internal member or may be completely discontinuous. You will understand further. The size of each of the first and/or second plurality of protrusions may vary depending on the desired application. In another aspect, the average size of the first and/or second plurality of protrusions is less than about 50%, less than about 40%, less than about 30%, less than about 20%, less than about 10%, Or it may even be less than about 5%.

Similar to other sheath configurations, in this sheath configuration, the resting diameter d _r may be substantially uniform along the longitudinal axis of the lumen, or may vary along the longitudinal axis of the lumen.

In some aspects, the interior surface of the inner liner can be substantially smooth. In another aspect, the interior surface of the tubular inner liner can be at least partially ribbed. In yet a further aspect, the tubular inner liner can be lubricant and have a coefficient of friction of less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, less than about 0.1.

A further configuration of the sheath is also shown in Figure 34 . In this aspect, variable diameter inner liner 3400 includes a sheet 3402 having a first longitudinal edge 3402a and a second longitudinal edge 3402b . The sheath inner liner 3400 has an inner surface 3403a and an outer surface 3405a . As shown in Figure 34 , the sheet is wound in a spiral configuration such that at least a portion of the inner surface 3403a of the sheet overlaps over at least a portion of the outer surface 3405b of the sheet to form an overlap portion. As further shown in FIG. 34 , at least a portion of the outer surface 3405a of the sheet may include a plurality of bonding portions 3420 at least partially embedded within the sheet. As illustrated in FIG. 34 , these plurality of bonded portions 3420 are disposed such that the outer surface 3405b of the sheet within the overlap portion is substantially free of these bonded portions.

In another aspect, in the disclosed helical configuration of the inner liner, a first longitudinal edge 3402a of the sheet can slide along at least a portion of the interior surface of the sheet and a second longitudinal edge 3402b is capable of sliding along at least a portion of the interior surface of the sheet. It can slide along at least a portion of the outer surface.

In another aspect, the sheet has a predetermined thickness. In this aspect, the sheet has a thickness of from about 0.002 inches to about 0.002 inches, including exemplary values of about 0.003, about 0.004, about 0.005, about 0.006, about 0.007, about 0.008, about 0.009, about 0.01, about 0.015, and about 0.02 inches. It can have any thickness from 0.025 inches. It will be further appreciated that the predetermined thickness of the sheet forming the inner liner of any of the configurations described herein may vary depending on the strength required as well as the amount of radial expansion desired. In this aspect, the plurality of bond sites shown in the exemplary sheath of FIG. 34 may have a depth (the depth of the bond sites embedded within the sheet itself) of less than or equal to about 50% of any of the predetermined values of the sheet thickness described above. there is. For example, the depth of the plurality of bonded portions may be about 50% or less, about 45% or less, about 40% or less, about 35% or less, about 30% or less, about 25% or less, about 20% or less of the predetermined thickness. It may be less than or equal to about 15%, less than or equal to about 15%, less than or equal to about 10%, or less than or equal to about 5%.

In another aspect, the bonding area is disposed on the exterior surface and is not or is only partially embedded within the sheet. In this aspect, the plurality of bonding portions may also extend at least partially from the outer surface of the sheet. In this exemplary embodiment, the extended portions of the plurality of bonded portions have a thickness of no more than about 50%, no more than about 45%, no more than about 40%, no more than about 35%, no more than about 30%, no more than about 25% of the predetermined thickness described above. , may have a height of about 20% or less, about 15% or less, about 15% or less, about 10% or less, or about 5% or less. In this exemplary embodiment, the plurality of bonded portions both extend from the outer surface of the sheet and are at least partially embedded within the sheet, and the height and depth of the plurality of bonded portions are less than or equal to about 50% of the predetermined thickness described above, and about 45% or less, about 40% or less, about 35% or less, about 30% or less, about 25% or less, about 20% or less, about 15% or less, about 15% or less, about 10% or less, or about 5% or less. .

In another aspect, the plurality of bonded portions have a thickness of up to about 1%, up to about 5%, up to about 10%, up to about 15%, up to about 20%, up to about 25%, up to about 30% of the predetermined thickness of the sheet itself. %, up to about 35%, up to about 40%, up to about 45%, or up to about 50%. In another embodiment, at least a portion of such bonded area may be at most about 1%, at most about 5%, at most about 10%, at most about 15%, at most about 20%, at most about 25%, When extending up to about 30%, up to about 35%, up to about 40%, up to about 45%, or up to about 50% above the outer surface, the plurality of bonded portions may have an average depth and an average height.

In embodiments where there are a plurality of bonded regions both embedded in the sheet and extending over the exterior surface, the depth and height of these bonded regions may be the same or different from one another depending on the particular application. In another aspect, the depth and/or height of each bonding site in the plurality of bonding sites may also be the same or different.

In another aspect, the sheet includes a first polymer composition. In this aspect, the first polymer composition may include high density polyethylene, polypropylene, polyamide, fluoropolymer, copolymers thereof, or blends thereof. Meanwhile, in yet a further aspect, the sheet may have a multilayer structure. In embodiments where there is more than one layer, each layer may include the same or different materials.

In another aspect, the plurality of bonding sites can include a second polymer composition. In this aspect, the second polymer composition is different from the first polymer composition. However, it is understood that the first and second polymer compositions may also be substantially the same, depending on the need and specific application. In another aspect, the second polymer composition comprises polyethylene, polypropylene, graft modified polyethylene or polypropylene, or combinations thereof. In some exemplary embodiments, the second polymer composition is grafted low-density polyethylene (LDPE), grafted medium-density polyethylene, grafted ultra-low-density polyethylene (ULDPE), grafted high-density polyethylene (HDPE), grafted heterogeneously branched linear low-density polyethylene (LLDPE), grafted Homogeneously branched linear ethylene polymers and substantially linear ethylene polymers, grafted polypropylene, or ethylene-vinyl acetate (EVA), or any combination thereof.

For example, and without limitation, the sheet may comprise HDPE, while the bonding site may comprise LDPE, or a trimer such as maleic anhydride modified polyolefin, such as, but not limited to, Orevac® (commercially available from Arkema). , ethylene acrylic acid copolymers such as DOW Chemical Primacor®, ethylene acrylate copolymers such as Lotryl® (commercially available from Arkema), ethylene glycidyl methacrylate copolymer, ethylene acrylic ester glycidyl methacrylate. terpolymers such as Lotader® (commercially available from Arkema), ethylene acrylic ester maleic anhydride trimers such as Lotader® or Orevac® (commercially available from Arkema), or combinations thereof.

In another aspect, the first polymer composition and the second polymer composition can be coextruded together to form an inner liner. In embodiments where the second polymer composition differs from the first polymer composition, it is understood that the two compositions are compatible with each other and do not cause delamination.

In another aspect, a plurality of bonding sites may be disposed along at least a portion of the length of the inner liner. In another aspect, a plurality of bonding sites may be disposed along the entire length of the inner liner. In another aspect, the plurality of bonding sites may be disposed on the outer surface of the sheet adjacent the distal end of the sheath (i.e., not in an overlapping portion). In another aspect, the plurality of bonding sites may be disposed on the outer surface of the sheet adjacent the proximal end of the sheath (i.e., not in an overlapping portion).

In an aspect, the plurality of bonding sites are arranged in a predetermined pattern to allow coupling with the outer layer and prevent axial movement of the outer layer during passage of the medical device through the lumen of the inner liner. In another aspect, the pattern can be any pattern desired for a particular application and allows bonding to the outer layer.

In some embodiments, the plurality of bonding sites are arranged in a predetermined pattern to bond the inner liner to the outer layer without compromising expansion of the inner liner upon passage of the medical device. Since the expansion can be achieved by sliding the first and second longitudinal edges and reducing the overlap, it is understood that no joint sites are placed within the overlap to avoid undesirable coupling and restrictions in sliding.

In another aspect, the plurality of bonding sites can have any desired shape. For example, and without limitation, the plurality of bonding portions may have a regular shape, an irregular shape, or any combination thereof. In certain embodiments, the plurality of bonding portions may comprise a regular shape, such as a continuous stripe along the length of the inner liner, or a discontinuous formation, such as a discrete circular shape, rectangular, diamond, trapezoidal shape, etc. Again, it is understood that the plurality of bonding portions may be at least partially embedded within the sheet, may be completely embedded within the sheet, or may extend at least partially over the outer surface of the sheet. In any of these aspects, the shape of each of the plurality of bonding portions may be the same, different, or may be any variation of that shape.

In another embodiment, each of the plurality of bonded portions has a thickness of less than about 50%, less than about 45%, less than about 40%, less than about 35%, less than about 30%, less than about 25%, less than about 20% of the predetermined thickness described above. % or less, about 15% or less, about 15% or less, about 10% or less, or about 5% or less. Meanwhile, in another embodiment, each of the plurality of bonded portions has a thickness of at most about 1%, at most about 5%, at most about 10%, at most about 15%, at most about 20%, at most about 25%, at most. It has a width of about 30%, up to about 35%, up to about 40%, up to about 45%, or up to about 50%.

In another aspect, each of the plurality of bonding sites comprises a plurality of bonding sites, including exemplary values of about 2X, about 3X, about 4X, about 5X, about 6X, about 7X, about 8X, and about 9X the thickness of the plurality of bonding sites. It has a width of about 1X to about 10X the thickness of the joint area.

In another embodiment, each of the plurality of bonding regions has a length of about 0.015'', about 0.02'', about 0.025'', about 0.03'', about 0.035'', about 0.04'', about 0.045'', about 0.05'' , about 0.055'', about 0.06'', about 0.065'', about 0.07'', about 0.075'', about 0.08'', about 0.085'', about 0.09'', about 0.095'', about 0.1'' , and has a width of about 0.01'' to about 0.15'', including exemplary values of about 0.11'', about 0.12'', about 0.13'', and about 0.14''.

In another aspect, the plurality of splice sites may comprise one splice site. In another aspect, the plurality of junction sites includes at least two junction sites. It will be appreciated that the number of bonding sites may be specifically selected depending on the desired application. It will be further understood that each of the plurality of bonding sites may be disposed at a predetermined distance from one another, wherein such predetermined distance may be selected depending on the desired application. In another embodiment, the number and location of the abutment sites allow sections of the outer jacket to expand as the inner member expands, but the outer jacket has an outer sheath relative to the inner member during insertion and withdrawal of the sheath into the body and when passing a medical device. It may be selected to provide adequate anchoring strength to substantially prevent axial movement of the jacket (elastomeric outer component).

In another aspect, instead of being disposed on the outer surface (liner) of the inner layer of the sheath, any one of the plurality of bonding sites disclosed may be disposed on the inner surface (outer jacket) of the outer layer of the sheath. In this exemplary embodiment, as shown, for example, in FIGS. 43A-43B , the inner liner may not include any bonding sites, while the inner surface of the outer layer may include one or more bonding sites. For example, the inner liner in this aspect can have any of the thicknesses described above. As described below, the outer layer may also have a predetermined thickness. For example, the predetermined thickness of the outer layer can vary along the length of the sheath. In another aspect, the predetermined thickness of the outer layer is the same along the length of the sheath. However, in a further aspect, the predetermined thickness of the outer layer is greater at the proximal end. In another aspect, the predetermined thickness of the outer layer is about 0.0015'', about 0.002'', about 0.0025'', about 0.003'', about 0.0035'', about 0.004'', about 0.0045'', about 0.005''. '', about 0.0055'', about 0.006'', 0.0065'', about 0.007'', about 0.0075'', about 0.008'', about 0.0085'', about 0.009'', 0.0095'', about 0.01'' , about 0.0105'', about 0.011'', about 0.01105'', about 0.012'', about 0.01205'', about 0.013'', about 0.01305'', about 0.014'', and about 0.01405''. up to 0.015'', for example and without limitation, from about 0.001'' to about 0.015''.

Figure 43B shows an enlarged view 4300 of the joint site. It can be seen that the outer layer may have one or more bonding sites with a width w. In this aspect, the width may be about 0.015'', about 0.02'', about 0.025'', about 0.03'', 0.035'', about 0.04'', 0.045'', about 0.05'', about 0.055'', About 0.06'', about 0.065'', about 0.07'', about 0.075'', about 0.08'', about 0.085'', about 0.09'', about 0.095'', about 0.1'', about 0.11'', It can have a value anywhere from about 0.01'' to about 0.15'', including exemplary values of about 0.12'', about 0.13'', and about 0.14''.

In another embodiment, the bonding area is about 0.0002'', about 0.0003'', about 0.0004'', about 0.0005'', about 0.0006'', about 0.0007'', about 0.0008'', about 0.0009'', about 0.0001'', including example values of 0.001'', about 0.0015'', about 0.002'', about 0.0025'', about 0.003'', about 0.0035'', about 0.004'', and about 0.0045''. It may have a thickness ranging from about 0.005''.

Any of the materials used to form the inner liner, outer layer (outer jacket), and bonding area disclosed herein may be used without limitation. It will be further understood that the plurality of bonding sites disposed on the inner surface of the outer layer (outer jacket) may have the same shape as the plurality of bonding sites disposed on the outer surface of the inner liner as described above. Any property or characteristic of a bond site disposed on the outer surface of the inner liner is applicable to a plurality of bond sites disposed on the inner surface of the outer jacket.

For example, and without limitation, the bonding portion may not be disposed on the inner surface of the outer jacket or may be only partially embedded within the outer jacket. It is understood that where the outer jacket consists of more than one polymer layer, the bonding site may be embedded in any or all of the polymer layers present in the outer jacket. In another aspect, the plurality of bonding sites can include a polymer capable of displacing at least a portion of at least one polymer layer at a predetermined location.

In embodiments where there is a plurality of bonding regions both embedded in the outer jacket and extending over the interior surface, the depth and height of these bonding regions may be the same or different depending on the particular application. In another aspect, the depth and/or height of each bonding site in the plurality of bonding sites may also be the same or different.

In another aspect, the interior surface of the sheet defines a lumen of the sheath with a longitudinal axis.

In yet a further aspect, the variable diameter inner liner is configured to slide a first edge of the sheet along at least a portion of the inner surface while applying a radial outward force by passing a medical device through a lumen of the inner liner and It is configured to expand from a first resting diameter d _r to a second expanded diameter d _e by sliding a second edge of the sheet along at least a portion of the surface.

In another aspect, the sheet is rolled to form a spiral with no sections having no more than three predetermined thicknesses in the radial direction and small portions having only one predetermined thickness in the radial direction. In certain embodiments, when the medical device passes through an expandable variable diameter inner liner, the applied radial force is high, and any friction or adhesion between the sliding portions undesirably increases the pressing force.

Similar to other sheath configurations, in this sheath configuration, the resting diameter d _r may be substantially uniform along the longitudinal axis of the lumen, or may vary along the longitudinal axis of the lumen.

In some aspects, the interior surface of the inner liner can be substantially smooth. In another aspect, the interior surface of the tubular inner liner can be at least partially ribbed. In yet a further aspect, the tubular inner liner can be lubricant and have a coefficient of friction of less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, less than about 0.1.

In another aspect, sheaths having inner liner examples disclosed herein may further include any of the outer layers, braids, tie layers, lubricants, etc. disclosed herein.

A further configuration of the inner liner is also shown in Figure 18 . 18 shows an inner liner 1800 comprising a sheet rolled in a helical configuration, where the sheet includes a first portion 1802 having a first surface 1802a and an opposing second surface 1802 . and the first end 1804 of the first portion 1802 has a first segment 1806 having a first surface 1806a and an opposing second surface 1806b and a first segment 1806 having a first surface 1808a and an opposing second surface. divided into a third segment 1808 having two surfaces 1808b , the second end of the first portion extending into a second segment 1810 having a first surface 1810a and an opposing second surface 1810b . do.

18 , in the helical configuration, at least a portion of the first surface 1810a of the second segment 1810 overlaps with at least a portion of the second surface 1806b of the first segment 1806 ; wherein at least a portion of the first surface 1808a of the third segment 1808 overlaps with at least a portion of the second surface 1810b of the second segment 1810 , and the first surface 1808a of the third segment ) overlaps at least a portion of the second surface 1806b of the first segment 1806 . Additionally, the first surface 1804a of the first portion 1804 is the first surface 1806a of the first segment 1806 , the first surface 1810a of the second segment 1810 , and the third segment 1808 . ) can be seen to extend into the first surface 1808a . It can also be seen that the second surface 1804b of the first portion 1804 extends into the second surface 1810b of the second segment 1810 and the second surface 1808b of the third segment 1808 . . Each of these segments can slide along one another and expand the sheath during passage of the medical device.

FIG. 19 shows an example sheath with an inner liner 1800 and an outer layer 1900 as shown in FIG. 18 .

Referring back to FIG. 18 , when at least a portion of the first surface 1810a of the second segment 1810 overlaps at least a portion of the second surface 1806b of the first segment 1806 , a first gap ( 1812 ) is formed between at least a portion of the first surface 1810a of the second segment 1810 and at least a portion of the second surface 1804b of the first segment 1806 .

Additionally, when at least a portion of the first surface 1808a of the third segment 1808 overlaps with at least a portion of the second surface 1810b of the second segment 1810 , a second gap 1814 is formed. It can be. Additionally, when at least a portion of the first surface 1808a of the third segment 1808 overlaps at least a portion of the second surface 1806b of the first segment 1806 , a third gap 1816 ) can be formed.

It will be appreciated that the first gap may have a substantially uniform width along the overlapping portion, or that this width may vary. Similarly, the second gap may have a substantially uniform width along the overlapping portion, or the width of the second gap may vary along the overlapping portion. Still further, the third gap may have a width that is substantially uniform or variable along the overlapping portion. In another aspect, the width between the gaps can be any desired width. For example, it will be appreciated that the width of each of the three gaps may be the same or may be different. In certain embodiments, some gaps have the same width while other gaps have different widths.

When a sheath as disclosed in FIGS. 18 and 19 is used, the first segment 1806 , second segment 1810 , and third segment 1808 slide along one another as the medical device passes through the lumen. and is configured to move, whereby the overlap between the first and second segments and between the second and third segments decreases, while the overlap between the first and third segments increases.

Similar to any of the sheath configurations disclosed herein, the diameter of the lumen of the sheath shown in Figure 19 increases from a first resting diameter ( d _r ) to a second expanded diameter ( d _e ). After the medical device has passed through the lumen, the first segment 1806 , the second segment 1808 , and the third segment 1810 are configured to slideably move in opposition to each other, such that the first segment and the third segment 1810 The overlap between the two segments, the second segment and the third segment, and the first segment and the third segment increases. After passage of the device, the diameter of the lumen decreases from the second expanded diameter d _e to a diameter substantially equal to the first resting diameter d _r .

As mentioned above , d _r can be uniform along the length of the sheath, or can vary from the proximal end of the sheath to the distal end of the sheath, as shown in FIGS. 3A-3C . It will be further understood that any of the d _r values disclosed herein are also applicable to sheath configurations as shown in Figures 18 and 19 .

During transcatheter aortic valve replacement (TAVR) procedures, sheaths as disclosed herein are used to provide access to the vasculature without trauma to the patient, which serves to maintain hemostasis and facilitate delivery of interventional devices. In order for the sheath to be as minimally invasive as possible, it must have a low profile at entry, or low outer diameter (OD). However, the sheath must be expanded once inside the body to a larger diameter to allow passage of catheters larger than the initial diameter of the sheath. The force that advances these devices through the sheath is generally referred to as the pressing force. For larger devices such as crimped valves on delivery systems (DS), as well as challenging vascular anatomy such as small, tortuous or constricted vessels, the pressing force during the procedure is very important. High pressing forces can cause procedural delays, physician dissatisfaction, and even the inability to complete the procedure.

An important function of the sheath is to have a clinically acceptable pressing force to advance the delivery system and valves throughout the sheath for all patient anatomy. In some aspects, lubrication is used to help reduce these pressing forces. Lubrication is placed between the layers sliding upward against each other, reducing the frictional forces that must be overcome to expand the sheath, allowing the DS to pass through the sheath more easily. Recent studies have shown that lubrication is necessary to reduce pressing forces to acceptable levels.

Additionally, the sheath configuration as disclosed herein may include a lubricant. Figure 23 shows an exemplary aspect of sheath 2300 . In this configuration, for example, a lubricant 2306 may be disposed between the inner liner 2302 and the outer layer 2304 .

For sheaths configured as shown in Figures 18 and 19 , lubricants may be disposed between any portion and segment in any amount and in any combination. In certain exemplary, non-limiting aspects, the lubricant may be disposed between the first and second segments, or between the second and third segments, or between the first and third segments, or any combination thereof. In another aspect, the lubricant may be disposed to be located on the innermost surface of the sheath, or the outermost surface of the sheath, or a combination thereof.

In another aspect, the lubricant may be disposed along the entire circumference of the inner liner or between at least a portion of the overlying portion of the seat and at least a portion of the sliding portion of the seat.

Additionally, the lubricant may be disposed along at least a portion of the interior surface of the seat or at least a portion of the exterior surface of the seat or a combination thereof.

Any lubricant known in the art may be used. In another aspect, the lubricant may include a PTFE-based lubricant or a silicone-based lubricant. In certain, and non-limiting, embodiments, the lubricant may include Christo Lube supplied by ECL, or MED10/6670 or PRO-3499 supplied by Nusil, or PRO-3595 supplied by Nusil. In another aspect, it will be appreciated that the amount of first and/or second lubricant may be determined as appropriate by one of ordinary skill in the art.

In another certain aspect, the lubricant may be disposed in a predetermined pattern, for example as shown in Figure 26 . In this aspect, the lubricant is disposed in a pattern 2609 , for example on the inner liner 2602 . It will be appreciated that pattern 2609 is exemplary only and that any desired pattern for any particular application may be applied.

Lubricants may be applied in any manner. For example, it can be applied manually. Because the lubricant is brushed onto the sheath by hand, it is difficult to precisely control how much lubricant is added to the sheath and exactly where the lubricant is applied to the sheath.

Accordingly, as disclosed herein, lubricants can also be applied by pad printing or spraying, making them suitable for large-scale manufacturing because the materials are applied in a precisely controlled and repeatable manner. Detailed methods of lubricant application are discussed below.

However, in embodiments where the lubricant is applied by pad printing, the lubricant has a temperature of about 650 cP, about 700 cP, about 750 cP, about 800 cP, about 850 cP, about 900 cP, about 950 cP, about 1,000 cP, about 1,050 cP. is understood to have a viscosity of about 600 to about 1,200 cP, including exemplary values of cP, about 1,100 cP, and about 1150 cP.

In embodiments where the lubricant is sprayed, the lubricant may have a viscosity of less than about 600 cP, or less than about 550 cP, less than about 500 cP, less than about 450 cP, less than about 400 cP, less than about 350 cP, or less than about 350 cP. there is.

In another embodiment, if the lubricant is cured prior to placing the outer layer on the inner liner of the sheath.

Lubricants can also form films. If a film of lubricant is formed, this film may have a thickness of less than about 20 μm, about 15 μm, about 10 μm, about 5 μm, about 1 μm, or even about 0.5 μm.

In another aspect, the inner liner of any of the constructions disclosed herein may include polyolefins, polyamides, fluoropolymers, copolymers thereof, or blends thereof. In another aspect, the polyolefin may include high density polyethylene, polypropylene, or combinations thereof.

In another aspect, the sheet may include one or more layers. In yet a further aspect, the sheet may have a multilayer structure. In some embodiments, when more than one layer is present, each layer may comprise the same or a different polymer. In another aspect, the sheet may have a predetermined thickness, which may be defined by one of ordinary skill in the art depending on the particular application. In certain embodiments, the predetermined thickness of the inner liner includes exemplary values of about 0.003, about 0.004, about 0.005, about 0.006, about 0.007, about 0.008, about 0.009, about 0.01, about 0.015, and about 0.02 inches. , may be about 0.002 inches to about 0.025 inches. It will be further appreciated that the predetermined thickness of the sheet forming the inner liner of any of the configurations described herein may vary depending on the strength required as well as the amount of radial expansion desired.

In certain embodiments, the inner liner of any of the sheath configurations described herein may comprise a compound material. For example, the polymer layer of the sheet used to form the inner liner may include compound materials including polyolefin and lubricating fillers. It is understood that any of the polyolefins described above may be used. In some exemplary embodiments, the polyolefin used in the compound material is high density polyethylene. In another aspect, the lubricating filler can be any filler that can improve the lubricity of the polymer layer and reduce the overall coefficient of friction of the liner. In some exemplary, non-limiting aspects, the lubricating filler may include any additive known to reduce friction and behave as a lubricant. In this exemplary, non-limiting embodiment, the lubricating filler may include one or more of graphene, reduced graphene oxide, carbon black, boron nitride, silicon, talc, polytetrafluoroethylene (PTFE), ethylene propylene fluoride, etc. there is. In another aspect, the lubricating filler includes PTFE filler. In another aspect, the PTFE filler is a powder.

In another aspect, the lubricating filler may be present in any amount. In some exemplary, non-limiting embodiments, the lubricating filler may be present in an amount from about 5% to about 20% by weight of the total weight of the compound material used to prepare the polymeric layer of the inner liner. In another embodiment, the lubricating filler is present in an amount of about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13% by weight. % by weight, about 14% by weight, about 15% by weight, about 16% by weight, about 17% by weight, about 18% by weight, about 19% by weight, or about 20% by weight.

In another aspect, sheets comprising such compound materials are lubricant and have a coefficient of friction of less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, less than about 0.1, or less than about 0.05, or even less than about 0.01. You can have it. It will be further understood that the sheet may have a coefficient of friction having any value between any two of the foregoing values.

Additionally, it will be appreciated that when the polymer layer of the sheet used to form the inner liner comprises the compound material disclosed herein, the sheath may be substantially free of separately disposed lubricant. For example, a lubricant as described above applied between overlapping portions of the inner liner or between the outermost surface of the inner liner and the innermost surface of the outer layer may not be necessary if the inner liner itself includes a lubricating filler. . However, embodiments of the sheath in which the inner liner includes a lubricating compound in its composition are also disclosed herein, and a separate lubricant as described above is still applied between the various parts of the sheath. In this exemplary embodiment, this additional lubricant, whether manually applied, pad printed, or sprayed, may be applied between a portion of the inner liner and the outer layer or all portions of the inner liner and outer layer as described above. It will also be appreciated that these additional lubricants may be applied in any desired pattern. It may also be applied along the entire length of the sheath, or only along some portions of the sheath. Lubricants may also be applied in different patterns on different parts of the sheath. However, in other embodiments, the lubricant may be applied in the same pattern along various portions of the sheath.

In another aspect, the interior surface of the sheet may be at least partially ribbed. In this exemplary aspect, the interior surface of the sheet may be at least partially wrapped prior to rolling the sheet into a helical configuration to form the inner liner.

In some embodiments, the sheath described herein comprising a lubricating material within the inner liner can exhibit a pressing force required to move an artificial device through the sheath that is similar to or even smaller than the pressing force of a substantially identical reference sheath rolled in a helical configuration. wherein the inner liner of a substantially identical reference sheath comprises a polymer layer substantially free of lubricating filler and includes an amount of lubricant disposed between the overlapping portions of the helical configuration and/or the outermost surface of the inner liner. That is, in some embodiments when comparing the performance of any of the disclosed herein, sheath configurations are compared, and in these exemplary, non-limiting embodiments, a sheath having a lubricating material within the inner liner and no additional lubricant present is an inner liner. It can perform similar or even better than a similar sheath that has no lubricating material present within it but has additional lubricant distributed between the various parts of the sheath.

In another aspect and as described herein, the sheath may also include a tie layer. In this aspect, for example, referring to Figures 25A-B , the tie layer may be disposed on the inner surface of the inner liner or the outer surface of the inner liner. Figures 25A-B show example coextruded tubes that can be used to form sheets rolled into a helical configuration. The specifics of how to form the inner liner are discussed in greater detail below. Here, Figures 25A-B show a coextruded tube 2502 comprising a polymer layer 2505 and a tie layer 2503 . Figure 25A shows that tie layer 2503 is coextruded with polymer layer 2505 such that the tie layer is located on the outer surface of the polymer layer. It will be understood that the outer surface of the polymer layer will define at least a portion of the outer surface of the inner liner when the outer surface of the polymer layer is helical in structure. FIG. 25B shows tie layer 2503 being coextruded with polymer layer 2505 such that tie layer 2503 is positioned on the interior surface of the polymer layer. It will be understood that the interior surface of the polymer layer will define at least a portion of the interior surface of the inner liner when the interior surface of the polymer layer is helical in structure.

It will be appreciated that polymer layer 2505 may be any of the polymer layers described above and may be used to make the sheet. In certain aspects, the polymer layer may be high density polyethylene.

In another aspect, tie layer 2503 may include any material suitable for the desired application. It is understood that the tie layer may have adhesive or bonding properties. In certain embodiments, the tie layer may be a polyurethane material, such as Tecoflex, or a polymer, copolymer, or terpolymer, such as a terpolymer such as, for example, maleic anhydride modified polyolefin, and, without limitation, Orevac® (from Arkema). commercially available), ethylene acrylic acid copolymers such as DOW Chemical Primacor®, ethylene acrylate copolymers such as Lotryl® (commercially available from Arkema), ethylene glycidyl methacrylate copolymers, ethylene acrylic ester glycol sidyl methacrylate terpolymers such as Lotader® (commercially available from Arkema), ethylene acrylic ester maleic anhydride trimers such as Lotader® or Orevac® (commercially available from Arkema).

In certain embodiments, the polymer layer and the tie layer have a total sheet thickness of about 0.003, about 0.004, about 0.005, about 0.006, about 0.007, about 0.008, about 0.009, about 0.01, about 0.015, and about 0.02 inches. It may be from about 0.002 inches to about 0.025 inches, inclusive. It will be further appreciated that the total thickness of the sheets forming the inner liner of any of the configurations described herein may vary depending on the strength required as well as the amount of radial expansion desired.

In another embodiment, the tie layer has a thickness of about 0.0011'', about 0.0012'', about 0.0013'', about 0.0014'', about 0.0015'', about 0.0016'', about 0.0017'', about 0.0018'', about 0.0019''. ', about 0.0020'', about 0.0021'', about 0.0022'', about 0.0023'', about 0.0024'', about 0.0025'', about 0.0026'', about 0.0027'', about 0.0028'', and about 0.0029 It may have a thickness of about 0.001'' to about 0.003'', including exemplary values of ''.

In another aspect, any one of the sheath configurations disclosed herein can have at least one lubricating liner, for example as shown in Figures 25C-D .

Figures 25C-D show an exemplary coextruded tube comprising a tie layer 2503 and a polymer layer 2505 , and the lubricating liner 2507 described above. These tubes can be used to form sheets that are rolled into a helical configuration. The specifics of how to form the inner liner are discussed in greater detail below. As can be seen herein, lubricating liner 2507 is disposed on tie layer 2503 . In one configuration, the tie layer and lubricating liner are understood to be disposed on the outer surface of the polymer layer ( Figure 25C ) or on the inner surface of the polymer layer ( Figure 25D ). In another aspect, the lubricating liner is bonded to the polymer layer of the sheet with a tie layer.

25E-H show various configurations of a helical configuration of sheet 2502 where the sheet includes a polymer layer 2505 , a tie layer 2503 , and a lubricating liner 2507 .

The lubricating liner can include any material that can reduce the coefficient of friction of the sheath. In some exemplary, non-limiting embodiments, the lubricant liner may include PTFE, polyether block amide, silicone-based liner, perfluoroalkoxy alkane-based liner, e-PTFE, ethylene tetrafluoroethylene, etc. In another aspect, the lubricating liner includes PTFE.

In another aspect, the total thickness of the sheath may be any of the thicknesses described above.

In another aspect, the at least one lubricating liner has a liner of about 0.0011'', about 0.0012'', about 0.0013'', about 0.0014'', about 0.0015'', about 0.0016'', about 0.0017'', about 0.0018''. ', 0.0019'', about 0.0020'', about 0.0021'', about 0.0022'', about 0.0023'', about 0.0024'', about 0.0025'', about 0.0026'', about 0.0027'', about 0.0028'' , about 0.0029'', about 0.0030'', about 0.0031'', about 0.0032'', about 0.0033'', about 0.0034'', about 0.0035'', about 0.0036'', about 0.0037'', about 0.0038'', 0.0039'', about 0.0040'', about 0.0041'', about 0.0042'', about 0.0043'', about 0.0044'', about 0.0045'', about 0.0046'', about 0.0047'', about 0.0048'', and It has a thickness of about 0.001'' to about 0.005'', including an exemplary value of about 0.0049''.

In another aspect, the lubricating liner can be further ribbed. It is also understood that embodiments comprising additional lubricants added separately from the lubricating liner are also disclosed. In this aspect, the additional lubricant can be disposed of by any of the methods disclosed herein. This can be placed manually, pad printed, or sprayed. It will be further understood that such additional lubricants, if present, may be disposed along a portion of the sheath length or along the entire length of the sheath in any of the predetermined patterns disclosed herein. In another embodiment, no additional lubricant is present when the lubricant layer as described herein is present.

In another aspect, the outer layer of either sheath configuration may comprise styrenic elastomers, polyurethanes, latex, copolymers thereof, blends thereof, or coextrudates thereof. In certain and non-limiting embodiments, the polymer may include polyether block ester copolymers, polyesters, polyvinyl chloride, thermoset silicones, poly-isoprene rubber, polyolefins, other medical grade polymers, or combinations thereof.

In another aspect, the outer layer may include one or more layers. In some embodiments, at least one layer includes a styrenic elastomer. In another aspect, at least one layer can include polyurethane. In another aspect, at least one layer includes a blend of styrenic elastomer and polyurethane.

It will be appreciated that the hardness of each layer of the disclosed sheath may also vary depending on the particular application and desired properties of the sheath. In some embodiments, the layer of the outer layer has a Shore A hardness of 20A to 50A, including exemplary values of about 25A, about 30A, about 35A, about 40A, and about 45A. have

In another embodiment, the polymer layer of the outer layer has a Shore hardness of less than 90 hardness, less than 80 hardness, less than 70 hardness, less than 60 hardness, less than 50 hardness, less than 40 hardness, less than 30 hardness, or less than 20 hardness. In another exemplary embodiment, the polymer layer of the outer layer has a hardness of about 30 hardness, about 35 hardness, about 40 hardness, about 45 hardness, about 50 hardness, about 55 hardness, about 60 hardness, about 65 hardness, and about 70 hardness. It has a Shore hardness of from about 25 hardness to about 75 hardness, including exemplary values.

The sheath as shown in any of the preceding configurations may also include an outer layer comprising a first polymer layer, wherein the first polymer layer is greater than 0% but less than 100% by weight of a polyether block. polymers containing amides, polyurethanes, or combinations thereof; less than about 65% inorganic filler based on the total weight of the first compound composition; and a first compound composition comprising up to about 20% solid lubricating filler based on the total weight of the first compound composition. However, it should be understood that there are also embodiments in which the disclosed sheath may include additional elements. These exemplary embodiments are disclosed herein as detailed below.

In certain embodiments, the outer layer includes a first polymer layer. In this exemplary embodiment, the first polymer layer has about 0.01%, about 1%, about 5%, about 10%, about 15%, about 20%, about 25%, about 30% by weight. %, about 35% by weight, about 40% by weight, about 45% by weight, about 50% by weight, about 55% by weight, about 60% by weight, about 65% by weight, about 70% by weight, about 75% by weight, about 80% by weight greater than 0% to less than 100% by weight of polyether block amide, polyurethane, or thereof, including exemplary values of about 85%, about 90%, about 95%, and about 99.9% by weight. A first compound composition comprising polymers comprising any combination.

In another embodiment, the first compound composition is 40% by weight, about 45% by weight, about 50% by weight, about 55% by weight, about 60% by weight, about 65% by weight, about 70% by weight, and about 75% by weight. from greater than about 35% to less than about 80% by weight of a polymer comprising polyether block amide, polyurethane, or any combination thereof, including exemplary values of

In certain embodiments, the polymer in the first compound composition comprises a polyether block amide. In this exemplary embodiment, the polyether block amide may include PEBAX® from Arkema. In another aspect, the polymer may include a polyurethane, such as NEUSoft®. In another aspect, the polymer may include a combination of polyether block amides, such as PEBAX® and polyurethane. It will be further understood that when mixtures of polymers are present, such mixtures may include each component in any amount relative to the other components to provide the desired polymer within the previously disclosed ranges.

In another embodiment, the first compound composition has less than about 60% by weight, less than about 55% by weight, less than about 50% by weight, less than about 45% by weight, less than about 40% by weight, less than about 35% by weight, less than about 30% by weight. % by weight, less than about 25% by weight, less than about 20% by weight, less than about 15% by weight, less than about 10% by weight, less than about 5% by weight, and less than about 1% by weight of inorganic filler. It may contain less than about 65% by weight of inorganic filler based on the total weight of the first compound composition.

In another embodiment, the inorganic filler is present in an amount of at least about 1%, at least about 2%, at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, It may be present in an amount of at least about 30% by weight, at least about 35% by weight, at least about 40% by weight, at least about 45% by weight, at least about 50% by weight, or at least about 55% by weight.

In another aspect, inorganic fillers may be used as fillers and may include any inorganic material acceptable for the desired application. In certain exemplary, non-limiting embodiments, the inorganic filler may include bismuth oxychloride, barium sulfate, bismuth subcarbonate, calcium carbonate, aluminum trihydrate, barite, kaolin clay, limestone, or any combination thereof. . Again, it is understood that inorganic fillers may include combinations of various fillers. In this exemplary embodiment, the amount of each filler in the combination can be in any range to provide a final combination that falls within the foregoing ranges disclosed.

In another embodiment, the first compound composition comprises about 0.01%, about 0.1%, about 0.5%, about 1%, about 2%, or about 3% by weight, based on the total weight of the first compound composition. %, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, about 10% by weight, about 11% by weight, about 12% by weight, about 13% by weight %, up to about 20% by weight, including exemplary values of about 14% by weight, about 15% by weight, about 16% by weight, about 17% by weight, about 18% by weight, about 19% by weight, and about 19.9% by weight. It may include a solid lubricating filler. In another embodiment, the solid lubricating filler may be present in up to about 20%, up to about 15%, or up to about 10% by weight based on the total weight of the first compound composition.

In another aspect, the solid lubricating filler may include any additive known to reduce friction and behave as a lubricant. In this exemplary, non-limiting embodiment, the solid lubricating filler may include one or more of graphene, reduced graphene oxide, carbon black, boron nitride, silicon, talc, polytetrafluoroethylene (PTFE), ethylene propylene fluoride, etc. You can. In another aspect, the solid lubricating filler includes PTFE filler. In another aspect, the PTFE filler is a powder.

In another aspect, the first compound composition may further include at least one adhesion reducing compound. Any compound known in the art that can reduce the stickiness of polymer compositions can be considered and used for the purposes of this disclosure. In another exemplary, non-limiting embodiment, the at least one adhesion reducing compound comprises ProPell ^™ from Foster Corporation.

In certain embodiments, the at least one adhesion reducing compound is present in an amount of 0.01%, about 0.05%, about 0.1%, about 0.5%, about 1%, or about 2% by weight, based on the total weight of the first compound composition. %, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, about 10% by weight, about 11% by weight, about 12% by weight % by weight, including exemplary values of about 13% by weight, about 14% by weight, about 15% by weight, about 16% by weight, about 17% by weight, about 18% by weight, and about 19% by weight. It may be present in an amount of 20% by weight. In another aspect, the at least one adhesion reducing compound is present in any amount having a value between any two of the preceding values. For example, and without limitation, the at least one adhesion reducing compound may be present in an amount of from about 1% to about 5% by weight, or from about 5% to about 10% by weight, based on the total weight of the first compound composition. there is.

In another aspect and as disclosed herein, the polymer in the first polymer layer composition has substantially the same hardness along the total length of the outer layer. However, it will be appreciated that the hardness of the polymer within the composition of the first polymer layer of the outer layer may also vary along the length of the outer layer. For example, and without limitation, disclosed herein are embodiments where the hardness of the polymer in the first polymer layer composition at the proximal end of the outer layer is different than the hardness of the polymer in the first polymer layer composition at the distal end of the outer layer.

In another aspect, the polymer in the first polymer layer composition comprises exemplary values of about 25D, about 30D, about 35D, about 40D, about 45D, about 50D, about 55D, about 60D, about 65D, and about 70D. , has a Shore D of about 20D to about 72D. In another embodiment, the polymer in the first polymer layer composition has a Shore D of about 20D to about 35D. In another embodiment, the polymer in the first polymer layer composition has a Shore D of about 30D. However, in another embodiment, the polymer in the first polymer layer composition has a Shore D of about 25D.

As disclosed herein, it will be appreciated that the outer layer may include embodiments where there is only one polymer layer. However, in other embodiments, two or more polymer layers may be present in the outer layer. In this exemplary embodiment, the outer layer may include a second polymer layer comprising a second compound composition comprising greater than 0% to 100% by weight of a polyether block amide, polyurethane, or compositions thereof. Similar to the first compound composition, the second polymer can be present in any amount falling within the disclosed ranges. For example, the second polymer layer may comprise greater than 0 weight percent, about 0.01 weight percent, about 1 weight percent, about 5 weight percent, about 10 weight percent, about 15% by weight, about 20% by weight, about 25% by weight, about 30% by weight, about 35% by weight, about 40% by weight, about 45% by weight, about 50% by weight, about 55% by weight, about 60% by weight, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, and about 99.9% by weight. In another aspect, the second polymer comprises exemplary values of about 95.5% by weight, about 96% by weight, 96.5% by weight, about 97% by weight, about 97.5% by weight, about 98% by weight, and about 98.5% by weight. , may be present in the second compound composition in an amount greater than about 95% by weight and less than about 99% by weight.

In another embodiment, the second compound composition comprises 0.01%, about 0.05%, about 0.1%, about 0.5%, about 1%, about 2% by weight, based on the total weight of the second compound composition. , about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, about 10% by weight, about 11% by weight, about 12% by weight. , up to 20% by weight, including exemplary values of about 13% by weight, about 14% by weight, about 15% by weight, about 16% by weight, about 17% by weight, about 18% by weight, and about 19% by weight. A reducing compound may additionally be included. In another aspect, the at least one adhesion reducing compound is present in any amount having a value between any two of the preceding values. For example, and without limitation, the at least one adhesion reducing compound may be present in an amount of from about 1% to about 5% by weight, or from about 5% to about 10% by weight, based on the total weight of the second compound composition. there is. In another aspect and as disclosed herein, the second compound composition can be substantially free of solid lubricating fillers.

It will be further understood that, in certain embodiments, the first polymer in the first compound composition may be the same as the second polymer in the second compound composition. However, in other embodiments, the first polymer in the first compound composition is different from the second polymer in the second compound composition. In another aspect, the second polymer layer composition includes PEBAX®. In a further aspect, the second polymer layer composition may comprise a polyurethane, such as NEUSoft® from PolyOne.

In another embodiment, the second polymer has a Shore D of about 20D to about 35D. However, in another embodiment, the second polymer has a Shore D of about 25D or about 35D.

In another aspect, the second compound composition may be substantially free of inorganic fillers. In certain embodiments, the inorganic filler is present in an amount of about 0.01% by weight, about 0.05% by weight, about 0.1% by weight, about 0.5% by weight, about 1% by weight, about 5% by weight, about 10% by weight, about 20% by weight, about 30% by weight. % by weight, including exemplary values of about 40 wt.%, about 50 wt.%, about 60 wt.%, about 70 wt.%, about 80 wt.%, about 90 wt.%, and about 95 wt.%. The second compound may be present in the composition in any amount from less than 100% by weight. In embodiments where an inorganic filler is present in the second compound composition, such inorganic filler may include any of the fillers described above.

In another aspect, and as disclosed herein, the outer layer has a predetermined thickness, wherein at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50% of the predetermined thickness. %, at least about 60%, at least about 70%, at least about 80%, at least about 90%, or 100% of the first and/or second polymers having a Shore D of less than or equal to about 30D. and a second compound composition.

In another aspect, the predetermined thickness of the outer layer can vary along the length of the sheath. In another aspect, the predetermined thickness of the outer layer is the same along the length of the sheath. However, in a further aspect, the predetermined thickness of the outer layer is greater at the proximal end. In another aspect, the predetermined thickness of the outer layer is up to 0.006'', for example and without limitation, about 0.0015'', about 0.002'', about 0.0025'', about 0.003'', about 0.0035'', from about 0.001'' to about 0.006'', including exemplary values of about 0.004'', about 0.0045'', about 0.005'', about 0.0055'', and about 0.006''.

In another aspect, the first polymer layer and the second polymer layer can have the same thickness. In another aspect, the first polymer layer and the second polymer layer have different thicknesses. For example, in some embodiments, the first polymer layer has a thickness of about 0.0011'', about 0.0012'', about 0.0013'', about 0.0014'', about 0.0015'', about 0.0016'', about 0.0017'', about 0.0018''. '', about 0.0019'', about 0.0020'', about 0.0021'', about 0.0022'', about 0.0023'', about 0.0024'', about 0.0025'', about 0.0026'', about 0.0027'', about 0.0028 It has a thickness of about .001'' to about 0.003'', including exemplary values of '', and about 0.0029''. Also, in a further embodiment, the second polymer layer has a thickness of about 0.0011'', about 0.0012'', about 0.0013'', about 0.0014'', about 0.0015'', about 0.0016'', about 0.0017'', about 0.0018''. ', about 0.0019'', about 0.0020'', about 0.0021'', about 0.0022'', about 0.0023'', about 0.0024'', about 0.0025'', about 0.0026'', about 0.0027'', about 0.0028' ', about 0.0029'', 0.0030'', about 0.0031'', about 0.0032'', about 0.0033'', about 0.0034'', about 0.0035'', about 0.0036'', about 0.0037'', about 0.0038'' , and may have a thickness of about 0.002'' to 0.004'', including exemplary values of 0.0039''.

In another aspect, the predetermined thickness of the outer layer is greater at the proximal end. In another aspect, the predetermined thickness of the outer layer is less at the distal end compared to the predetermined thickness of the outer layer at the proximal end.

In another embodiment where two or more layers are present in the outer layer, a first polymeric layer can define the inner surface of the outer layer, while a second polymeric layer can define the outer surface of the outer layer. However, there are also embodiments where the first polymer layer defines the outer surface of the outer layer, while the second polymer layer defines the inner surface of the outer layer. It is also understood that other embodiments in which one or more additional polymer layers are disposed between the first polymer layer and the second polymer layer are also encompassed.

In another aspect, the outer layer is extruded as a tube that can be slid on the inner liner of the sheath. In embodiments where there are first and second polymer layers, these polymer layers may be coextruded. In another aspect, the first polymer layer can be substantially bonded to the second polymer layer. In this exemplary embodiment, the first polymer layer does not substantially delaminate from the second polymer layer. It will be understood that in some embodiments the bonding may be physical or chemical or any other type known in the art.

In another aspect, any one of the sheaths comprising an outer layer disclosed herein has less than about 55 N, less than about 50 N, less than about 45 N, less than about 40 N, less than about 35 N when a medical device is pushed through the sheath. It may exhibit an insertion force of less than, or less than about 35 N.

In another embodiment, the outer layer further comprises at least one of polytetrafluoroethylene, fluorinated ethylene propylene, or high-density polyethylene having a diameter of about 0.300'' in the dry state, or about It may exhibit a frictional force of less than 9 N, or less than about 8 N, or less than about 7 N, or less than about 6 N, or even less than about 5 N.

In another embodiment, the outer layer extruded as a tube has a force of less than about 10 N, or less than about 9 N, or less than about 8 N, or less than about 7 N, or about 6 N at a 10 mm extension (about 85% strain). It may exhibit a hoop force of less than, or even about 5 N. In this exemplary embodiment, the extruded tube forming the outer layer of the sheath may have a diameter and wall thickness of about 0.290'' (7.4 mm) as disclosed herein. In embodiments where the outer layer has a diameter of about 0.290'' (7.4 mm) and a total wall thickness of about 0.0045'', the hoop orientation at a 10 mm extension for a sample length of about 0.25'' (6.4 mm) The force may be less than about 8 N. It will be appreciated that in some exemplary, non-limiting embodiments, lower forces at 10 mm extension are desirable for lower sheath extension forces.

In another aspect, the outer layer can exhibit an elongation at break ranging from about 650% to about 800%, including exemplary values of about 680%, about 700%, about 710%, about 750%, and about 780%. there is. It will be appreciated that in some exemplary, non-limiting embodiments, high elongation rates are desirable in order for the outer layer to expand to a larger diameter before rupturing.

In certain embodiments, the outer layer extends along a portion of the length of the sheath. In this exemplary embodiment, the outer layer may be located at the proximal end of the sheath, or in the middle of the sheath, or at the distal portion of the sheath. In other embodiments, the outer layer extends along the entire length of the sheath. In this exemplary embodiment, the outer layer can be positioned at the proximal end of the sheath and extend to the distal end of the sheath.

In another aspect, the outer layer of any of the cis configurations disclosed herein can include one or more polymeric layers. In some aspects, the first polymer layer can be the first polymer layer described above. However, in other embodiments, the outer layer can also include a second polymer layer, where the second polymer layer can be any of the second polymer layers described above. In some exemplary, non-limiting aspects, the second polymer layer can include polyurethane. In some exemplary, non-limiting embodiments, the first polymer layer may include PEBAX, alone or in combination with inorganic fillers and solid lubricating fillers, as described above. In another exemplary, non-limiting aspect, the second polymer layer can include a polyurethane, such as Neusoft.

In certain embodiments, the first polymer layer and the second polymer as described above may be coextruded to form a bump tube. Bumped tubes or tapered tubes are understood to be commonly used in a variety of applications.

It will be appreciated that in some aspects, bumped tubes or tapered tubes may be particularly useful for certain catheter applications. Neurovascular and microcatheters generally rely on larger proximal diameters to increase the pressurability of the device, while smaller distal ends provide improved performance and deliverability.

In some aspects disclosed herein, the bump tube forming the outer layer of the sheath can have a predetermined length that is substantially similar to the length of the sheath. However, in other embodiments, the bump tubes that form the outer layer of the sheath may have a predetermined length that is shorter than the length of the sheath.

In certain embodiments, the first polymer layer may define the inner surface of the outer layer (bump tube). In this embodiment, the second polymer layer will define the outer surface of the outer layer.

However, in other embodiments, this may define the outer surface of the outer layer (bump tube). In this embodiment, the second polymer layer will define the inner surface of the outer layer.

In another embodiment where the outer layer has the configuration described above, the first polymer layer has a thickness of about 0.002'', about 0.0025'', about 0.003'', about 0.0035'', about 0.004'', about 0.0045'', about 0.005'' '', about 0.0055'', about 0.006'', 0.0065'', about 0.007'', about 0.0075'', about 0.008'', about 0.0085'', about 0.009'', and about 0.0095''. It may have a thickness of about 0.001'' to about 0.010'', inclusive. It is understood that the thickness of the first polymer layer within the outer layer may be uniform along the length of the sheath. However, in other embodiments, the thickness of the first polymer layer within the outer layer can vary along the length of the sheath. In some embodiments, the thickness of the first polymer layer is greater at the proximal end of the sheath compared to the thickness of the first polymer layer along other portions of the sheath. However, in other embodiments, the thickness of the first polymer layer may be less at the distal end of the sheath compared to the thickness of the first polymer layer at the proximal end of the sheath.

In some embodiments, the second polymer layer, when present in the outer layer, has a thickness of about 0.002'', about 0.0025'', about 0.003'', about 0.0035'', about 0.004'', about 0.0045'', about 0.005''. Exemplary values of ', about 0.0055'', about 0.006'', 0.0065'', about 0.007'', about 0.0075'', about 0.008'', about 0.0085'', about 0.009'', and about 0.0095''. It may have a thickness of about 0.001'' to about 0.010'', including. It is understood that the thickness of the second polymer layer within the outer layer may be uniform along the length of the sheath. However, in other embodiments, the thickness of the outer polymer layer within the outer layer can vary along the length of the sheath. In some embodiments, the thickness of the second polymer layer is greater at the proximal end of the sheath compared to the thickness of the second polymer layer along other portions of the sheath. However, in other embodiments, the thickness of the second polymer layer may be less at the distal end of the sheath compared to the thickness of the second polymer layer at the proximal end of the sheath.

In another aspect, the first polymer layer has a thickness of about 20D, including exemplary values of about 25D, about 30D, about 35D, about 40D, about 45D, about 50D, about 55D, about 60D, about 65D, and about 70D. It may have a Shore D of from about 72D. In another embodiment, the polymer in the first polymer layer composition has a Shore D of about 20D to about 35D. In another embodiment, the polymer in the first polymer layer composition has a Shore D of about 30D. However, in another embodiment, the polymer in the first polymer layer composition has a Shore D of about 25D.

However, in other embodiments, the second polymer layer has an electrical current of about 30A to about 80A, including exemplary values of about 40A, about 45A, about 50A, about 55A, about 60A, about 65A, about 70A, and about 75A. You can have Shore A.

In another aspect, and as disclosed herein, the outer layer has a predetermined total thickness, wherein at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least About 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, or 100% comprises a first compound composition comprising a first polymer having a Shore D of about 20D to about 35D. do. In another aspect, the predetermined total thickness of the outer layer is at most about 0.02'', or at most about 0.015'', or at most about 0.01'', or at most about 0.009'', or at most about 0.008'', or at most about 0.008''. 0.007'', or up to about 0.006''.

In another aspect, the predetermined total thickness of the outer layer may be uniform along the length of the sheath, or may vary along the length of the sheath. In some exemplary, non-limiting embodiments, the predetermined total thickness of the outer layer is greater at the proximal end of the sheath. However, in other embodiments, the total predetermined thickness of the outer layer is less at the distal end of the sheath compared to the total predetermined thickness of the outer layer at the proximal end of the sheath.

Also disclosed herein are aspects of the sheath where the outer layer has more than one layer and these layers are formed separately. For example, as described above, the first and second polymer layers are formed separately instead of being coextruded. In this embodiment, the outer layer is formed by placing one of the polymer layers on top of the other.

In some exemplary, non-limiting aspects, the second polymer layer can be at least partially disposed over the first polymer layer. Also disclosed are embodiments where the first polymer layer at least partially overlies the second polymer layer.

In certain embodiments, when two polymers are formed separately and placed relative to each other, each polymer layer can have a different length.

In some exemplary, non-limiting aspects, the first polymer layer can have a length that is shorter than the length of the second polymer layer. In some embodiments, the first polymer layer can be disposed on the inner liner at the proximal end of the sheath, about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm. It can have a length of about 5 cm to about 15 cm, including exemplary values of about 13 cm, and about 14 cm. In another aspect, the second polymer layer is then disposed on the first polymer layer. In this aspect, the second polymer layer can have any length suitable for the desired application. In certain embodiments, the second polymer layer can have a length substantially equal to the length of the sheath.

However, it is understood that opposing configurations of the outer layer are also disclosed. In this embodiment, the second polymer layer may be disposed first on the inner liner and may have a length shorter than that of the sheath. Additionally, the second polymer layer can be disposed on the second polymer layer. In this exemplary embodiment, the first polymer layer can have any length. In some aspects, the length of the first polymer layer can be substantially the same as the length of the sheath.

Additionally, as disclosed in these embodiments, the first polymer layer may have a uniform thickness along the length of the first polymer layer, or may vary along the length of the first polymer layer. For example, the thickness of the first polymer layer (d2, e.g., shown in Figure 42B ) 4200 can be any thickness as described above. In some embodiments, the thickness has exemplary values of about 0.002'', about 0.0025'', about 0.003'', about 0.0035'', about 0.004'', about 0.0045'', about 0.005'', and about 0.0055''. It can be any value from about 0.001'' to about 0.006'', including.

Additionally, as disclosed in these embodiments, the second polymer layer may have a uniform thickness along the length of the second polymer layer, or may vary along the length of the second polymer layer. The thickness of the second polymer layer may be any of the thicknesses described above. In some embodiments, the thickness (d1) of the second polymer is about 0.002'', about 0.0025'', about 0.003'', about 0.0035'', for example, as shown in Figure 42C ( 4200 ). 0.004'', about 0.0045'', about 0.005'', about 0.0055'', about 0.006'', 0.0065'', about 0.007'', about 0.0075'', about 0.008'', about 0.0085'', about 0.009 ', and can have any value from about 0.001'' to about 0.010'', including exemplary values of about 0.0095''.

In another embodiment, the total thickness of the outer layer is about 0.0015'', about 0.002'', about 0.0025'', about 0.003'', about 0.0035'', about 0.004'', about 0.0045'', about 0.005''. ', about 0.0055'', about 0.006'', 0.0065'', about 0.007'', about 0.0075'', about 0.008'', about 0.0085'', about 0.009'', 0.0095'', about 0.01'', Example values include about 0.0105'', about 0.011'', about 0.01105'', about 0.012'', about 0.01205'', about 0.013'', about 0.01305'', about 0.014'', and about 0.01405''. It can have any value from about 0.001'' to about 0.015''.

In another aspect, the outer layer disclosed herein can include at least two polymer layers. In another aspect, the outer layer disclosed herein can include at least one intermediate reinforcement layer disposed between the first polymer layer and the second polymer layer. In another aspect, the at least one intermediate reinforcing layer is a polymeric layer.

In some embodiments, at least one middle layer can extend along the entire circumference of the outer layer. In another embodiment, wherein the first polymer layer forms the inner surface of the outer layer and the second polymer layer forms the outer surface of the outer layer, the middle layer is disposed between the outer surface of the first polymer and the inner surface of the second polymer layer. do. In another aspect, and as described above, where the second polymer layer forms the inner surface of the outer layer and the first polymer layer forms the outer surface of the outer layer, the middle layer is formed with the outer surface of the second polymer layer and the second polymer layer. 1 is placed between the inner surfaces of the polymer layers. In another aspect, the intermediate reinforcing layer can bond the first and second polymer layers and can also assist in bonding the outer layer generally to the inner members of the sheath.

In another aspect, at least one middle layer has a finite width that is less than the circumference of the outer layer. In this embodiment, the at least one intermediate layer may be inserted as a strip between the first and second polymer layers. In some exemplary, non-limiting embodiments, when the outer layer has a distal outer diameter of about 0.200'', the strip has a distal outer diameter of about 0.03'', about 0.035'', about 0.04'', about 0.045'', about 0.05'' , about 0.055'', about 0.06'', about 0.065'', about 0.07'', about 0.075'', about 0.08'', about 0.085'', about 0.09'', about 0.095'', about 0.10'' , about 0.105'', about 0.110'', about 0.115'', about 0.120'', about 0.125'', about 0.130'', about 0.135'', about 0.140'', and about 0.145''. It may have a width (e.g., shown in FIG. 42 ) 4200 of about 0.010'' to about 0.150'', including. It will be appreciated that the above-described widths are exemplary and that if the distal outer diameter of the outer layer has a size different from 0.200'', the strip width may be adjusted to the same or different ratios.

In another aspect, at least one middle layer has a finite width that is less than the circumference of the outer layer. In this embodiment, the at least one intermediate layer may be inserted as a strip between the first and second polymer layers. In some exemplary, non-limiting embodiments, when the outer layer has a distal outer diameter of about 0.200'', the strip may have a width of about 5% to about 50% of the circumference of the outer layer. In another embodiment, the total combined width of the strips is about 5%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, or about It is 50%. It will be appreciated that the foregoing widths are exemplary and that if the distal outer diameter of the elongate sheath has a size different from 0.200'', the strip widths may be adjusted to the same or different ratios.

In another aspect, the outer layer may include two or more middle layers. In this embodiment, the two or more intermediate layers may be disposed circumferentially between the first and second polymer layers at a distance from each other as individual strips. In embodiments where two or more intermediate layers are disposed between the first and second polymer layers of the outer layer, the total combined width of all strips is from about 5% to about 50% of the circumference of the outer layer. In another embodiment, the total combined width of the strips is about 5%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, or about It is 50%.

In another aspect, the at least one intermediate layer is configured to provide axial reinforcement to the outer layer and, in turn, to provide axial reinforcement to the sheath in which the outer layer may be used. In this exemplary embodiment, the at least one intermediate layer may be disposed along the length of the outer layer or along a portion of the length of the outer layer.

In some embodiments, the portion of the length of the outer layer over which the at least one middle layer is disposed is located at the distal end and/or proximal end of the outer layer. In another aspect, the at least one intermediate layer may also be located anywhere along the length of the outer layer.

It will be further understood that in embodiments where the intermediate layer is present as one or more strips disposed circumferentially along the length of the sheath, the width of the strips may be the same along the length, or may vary along the length. In embodiments where the width of the strip varies along the length of the outer layer, such strip may have any of the previously disclosed width values.

In another aspect, the first polymer layer used in this exemplary outer layer can be any of the first polymer layers described above. In a further exemplary, non-limiting embodiment, the first polymer layer forms the inner surface of the outer layer and comprises greater than 0% to less than 100% by weight of a polyether block amide, poly, based on the total weight of the first compound composition. polymers comprising urethane or combinations thereof; less than about 65% inorganic filler based on the total weight of the first compound composition; and a first compound composition comprising up to about 20% solid lubricating filler based on the total weight of the first compound composition.

Either of the inorganic fillers and solid lubricating fillers described above may be present in any amount as disclosed. For example, the inorganic filler may include bismuth oxychloride, barium sulfate, bismuth subcarbonate, calcium carbonate, aluminum trihydrate, barite, kaolin clay, limestone, or any combination thereof. In another aspect, the inorganic filler may be present at at least 10% by weight. In another embodiment, the inorganic filler may be present in an amount of less than about 50% by weight based on the total weight of the first compound composition.

In another aspect, the solid lubricating filler may include PTFE filler.

The first compound may also include any of the disclosed additives. For example, the compound may include at least one adhesion reducing compound in an amount from about 1% to about 20% by weight.

In another exemplary embodiment, the polymer present in the first compound can have a Shore D of about 20D to 35D, including exemplary values of about 22D, about 25D, about 27D, about 30D, and about 32D. .

In another aspect, the hardness of the polymer in the first polymer layer composition at the proximal end of the outer layer can be different than the hardness of the polymer in the first polymer layer composition at the distal end of the outer layer.

In another aspect, the polymer in the first compound may comprise a polyether block amide, such as PEBAX®. In another aspect, the polymer in the first compound may include polyurethane. In another aspect, the first compound may include a polyamide.

In another embodiment, the thickness of the first polymer layer is about 1.1 millimeters, about 1.2 millimeters, about 1.3 millimeters, about 1.4 millimeters, about 1.5 millimeters, about 1.6 millimeters, about 1.7 millimeters, about 1.8 millimeters, about 1.9 millimeters, about 2.0 millimeters, 2.1 millimeters, about 2.2 millimeters, about 2.3 millimeters, about 2.4 millimeters, about 2.5 millimeters, about 2.6 millimeters, about 2.7 millimeters, about 2.8 millimeters, about 2.9 millimeters, about 3.0 millimeters, about 3.1 millimeters, about 3.2 millimeters, About 3.3 millimeters, about 3.4 millimeters, about 3.5 millimeters, about 3.6 millimeters, about 3.7 millimeters, about 3.8 millimeters, about 3.9 millimeters, about 4.1 millimeters, about 4.2 millimeters, about 4.3 millimeters, about 4.4 millimeters, about 4.5 millimeters, about 4.6 may be from about 1 millimeter to about 5 millimeters, including example values of millimeters, about 4.7 millimeters, about 4.8 millimeters, and about 4.9 millimeters.

In another aspect, the second polymer layer can include any of the polymers described above. In some embodiments, the second polymer layer can include a second compound composition comprising greater than 0% to 100% by weight of a polyether block amide, polyurethane, or compositions thereof. In another aspect, the second polymer layer can include polyamide. In some other embodiments, the second compound may also include any of the fillers or additives described above. In some embodiments, the second compound does not include a solid lubricant filler disclosed herein. In another aspect, the second compound may include a stickiness reducing additive described in this disclosure. In some aspects, the second polymer can be polyurethane. In another aspect, the polyurethane is a thermoplastic polyurethane.

In another aspect, the second polymer may be a blend comprising polyurethane with a styrene block copolymer. In another aspect, the blend may further include additional polymers and copolymers. For example, ether-based polymers may be present in the formulation. In some exemplary, non-limiting embodiments, the second polymer may be selected from commercially available polymers sold under the Neusoft ^™ trade name. In another aspect, the second polymer has an electrical current of about 20A, including exemplary values of about 25A, about 30A, about 35A, about 40A, about 45A, about 50A, about 55A, about 60A, about 65A, and about 70A. It may have a Shore A of from about 75A. In another aspect, the second polymer can have a Shore A hardness of less than 60A. In some exemplary embodiments, the second polymer can be Neusoft ^TM 597-50A.

In another embodiment, the thickness of the second polymer layer is about 1.1 millimeters, about 1.2 millimeters, about 1.3 millimeters, about 1.4 millimeters, about 1.5 millimeters, about 1.6 millimeters, about 1.7 millimeters, about 1.8 millimeters, about 1.9 millimeters, about 2.0 millimeters, 2.1 millimeters, about 2.2 millimeters, about 2.3 millimeters, about 2.4 millimeters, about 2.5 millimeters, about 2.6 millimeters, about 2.7 millimeters, about 2.8 millimeters, about 2.9 millimeters, about 3.0 millimeters, about 3.1 millimeters, about 3.2 millimeters, About 3.3 millimeters, about 3.4 millimeters, about 3.5 millimeters, about 3.6 millimeters, about 3.7 millimeters, about 3.8 millimeters, about 3.9 millimeters, about 4.1 millimeters, about 4.2 millimeters, about 4.3 millimeters, about 4.4 millimeters, about 4.5 millimeters, about 4.6 millimeter, about 4.7 millimeters, about 4.8 millimeters, about 4.9 millimeters, about 5.1 millimeters, about 5.2 millimeters, about 5.3 millimeters, about 5.4 millimeters, about 5.5 millimeters, about 5.6 millimeters, about 5.7 millimeters, about 5.8 millimeters, and about 5.9 millimeters It can be from about 1 millimeter to about 6 millimeters, including exemplary values of . In another embodiment, the thickness of the at least one intermediate reinforcing layer is about 1.1 millimeters, about 1.2 millimeters, about 1.3 millimeters, about 1.4 millimeters, about 1.5 millimeters, about 1.6 millimeters, about 1.7 millimeters, about 1.8 millimeters, about 1.9 millimeters, About 2.0 millimeters, 2.1 millimeters, about 2.2 millimeters, about 2.3 millimeters, about 2.4 millimeters, about 2.5 millimeters, about 2.6 millimeters, about 2.7 millimeters, about 2.8 millimeters, about 2.9 millimeters, about 3.0 millimeters, about 3.1 millimeters, about 3.2 millimeters , about 3.3 millimeters, about 3.4 millimeters, about 3.5 millimeters, about 3.6 millimeters, about 3.7 millimeters, about 3.8 millimeters, about 3.9 millimeters, about 4.1 millimeters, about 4.2 millimeters, about 4.3 millimeters, about 4.4 millimeters, about 4.5 millimeters, about 4.6 millimeters, about 4.7 millimeters, about 4.8 millimeters, about 4.9 millimeters, about 5.1 millimeters, about 5.2 millimeters, about 5.3 millimeters, about 5.4 millimeters, about 5.5 millimeters, about 5.6 millimeters, about 5.7 millimeters, about 5.8 millimeters, and about 5.9 millimeters It can be any value from about 1 millimeter to about 6 millimeters, including example values of millimeters.

In another aspect, at least one intermediate layer can include any one of the polymers disclosed herein. In some embodiments, at least one intermediate layer may include the first compound described above. In another aspect, at least one intermediate layer may include the second compound described above. In another aspect, at least one intermediate layer can include the first compound. However, in another aspect, the at least one intermediate layer can comprise any polymer known in the art and suitable for the desired application. In some embodiments, at least one intermediate layer can include polyether block amide, polyurethane, or combinations thereof. In another embodiment, the at least one intermediate layer is a polyether block amide, such as PEBAX®. In another aspect, the middle layer is polyurethane. In this exemplary embodiment, the at least one intermediate layer does not include a solid lubricating filler, such as PTFE. In another embodiment, the at least one intermediate layer does not include an inorganic filler. In another aspect, at least one intermediate layer has about 45D (85A), including exemplary values of about 50D, about 55D, about 60D, about 65D, about 70D, about 72D, about 75D, about 80D, and about 85D. ) to about 90D of Shore D (or Shore A) hardness.

In another aspect, the at least one intermediate reinforcing layer can include polyolefin. In another aspect, the at least one intermediate reinforcing layer may include polyethylene, polypropylene, graft modified polyethylene, or polypropylene. In a further embodiment, the at least one intermediate reinforcing layer is grafted low-density polyethylene (LDPE), grafted medium-density polyethylene, grafted ultra-low-density polyethylene (ULDPE), grafted high-density polyethylene (HDPE), grafted heterogeneously branched linear low-density polyethylene (LLDPE), grafted Homogeneously branched linear and substantially linear ethylene polymers, grafted polypropylene, or ethylene-vinyl acetate (EVA), or any combination thereof. In this exemplary embodiment, maleic anhydride or acrylic acid may be used to graft the polymers described above. In another aspect, the at least one intermediate reinforcing layer may include maleic anhydride or acrylic acid grafted low density polyethylene. In another aspect, the at least one intermediate reinforcement layer may comprise maleic anhydride or acrylic acid grafted polypropylene. In another aspect, the at least one intermediate reinforcing layer may include maleic anhydride or acrylic acid grafted ethylene vinyl acetate. In another embodiment, the at least one intermediate reinforcing layer may comprise maleic anhydride grafted polyolefin sold under the trade name OREVAC®.

In another aspect, any one of the at least one intermediate reinforcing layers disclosed above may thermally couple the outer layer to the variable inner liner of the sheath. In another aspect, the intermediate reinforcement layer can be extruded to be positioned between the first and second polymer layers. In another aspect, the at least one intermediate reinforcement layer can be fused with the first and second polymer layers by at least one of heat or compression.

In another aspect, the outer layer as disclosed herein comprising at least one intermediate reinforcing layer has a thickness of less than about 50N, less than about 49N, less than about 48N, less than about 47N, less than about 46N, less than about 45N, less than about 44N, about It may exhibit an extension force of less than 43 N, less than about 42 N, less than about 41 N, or even less than about 40 N. However, the expansion force is further understood to be dependent on the size of the medical device passing through the sheath. The exemplary values described above are suitable for a medical heart implant of approximately 26 mm. It is understood that the value of the force is not limited to the above-mentioned value but is adjusted depending on the device size.

In another aspect, the outer layer as disclosed herein comprising at least one intermediate reinforcing layer has a pressure greater than about 4.5 psi, greater than about 5 psi, greater than about 5.5 psi, greater than about 6 psi, greater than about 6.5 psi, greater than about 7 psi. Above, about 7.5 psi, above about 8 psi, above about 8.5 psi, above about 9 psi, above about 9.5 psi, above about 10 psi, above about 10.5 psi, above about 11 psi, about 11.5 psi, above about 12 psi , greater than about 12.5 psi, greater than about 13 psi, greater than about 13.5 psi, greater than about 14 psi, greater than about 14.5 psi, or greater than about 15 psi.

35-36 , outer layer 140 may include one or more axial reinforcement members 145 extending longitudinally along all or a portion of outer layer 140 . The stiffening elements 145 help prevent axial crowding of the outer layer 140 during insertion into the patient's vasculature, without sacrificing the low radial extensibility of the outer layer 140 .

As shown in FIG. 10 , sheath 100 may include a tapered portion adjacent a flared end portion 114 at the proximal end of sheath 100 . The tapered segments and flared end portions 114 , referred to as strain relief sections, help facilitate the transition between the smaller diameter portion of the sheath 100 and the housing 101 . If an outer layer 140 is present, its thickness and/or composition may be adjusted to improve performance of the strain relief section and reduce pressing forces as described above.

For example, in certain aspects, outer layer 140 may be bonded to the proximal end and/or distal end of the inner liner. At the proximal and distal ends, outer layer 140 may be bonded to the inner liner around the entire circumference of the outer layer.

As disclosed herein, the outer layer may have the same diameter across the length of the sheath, or may have varying diameters across the length of the sheath. Figure 37 is an elevation view of outer layer 140 showing the tapered portion adjacent the flared end portion at the proximal end of the sheath. Figure 38 is a cross-sectional view of an exemplary elongated tube taken along line AA in Figure 37 . Figure 39 is a cross-sectional view of the outer layer 140 , taken along section BB in Figure 37 . As mentioned above, the tapered portion is referred to as the strain relief section, and the tapered segments and flared proximal ends help facilitate the transition between the smaller diameter portion of the sheath 100 and the housing 101 . The length (L1) of the proximal end may range from 1.600 inches to 2.400 inches. In some embodiments, the proximal end is about 2.000 inches long. The length (L2) of the tapered segment may range from 2.000 inches to 3.000 inches. In some embodiments, the length (L2) of the tapered segment is about 2.500 inches. The overall length (L3) of the outer layer 140 /sheath 100 may range from 17.600 inches to 26.400 inches. In some embodiments, the overall length (L3) of the outer layer ( 140 )/sheath ( 100 ) is about 22.000 inches.

As provided in Figure 38 , the diameter of outer layer 140 at the proximal end is greater than the diameter of outer layer 140 at the distal end. This allows the outer layer 140 to slide over the inner liner 108 without the need for expansion. For example, the diameter D1 of outer liner 140 at the proximal end may range from 0.264 inches to 0.396 inches. In some embodiments, the diameter D1 of outer liner 140 at the proximal end is about 0.330 inches. The diameter D2 of outer layer 140 at the distal end may range from 0.176 inches to 0.264 inches. In some embodiments, the diameter (D2) of the outer layer at the distal end is about 0.220 inches.

In another aspect, the outer layer 140 may include two or more reinforcing members 145 . In this embodiment, the two or more reinforcing members 145 may be disposed as individual strips and positioned circumferentially between the first polymer layer, the second polymer layer, or the first and second layers at a predetermined distance from each other. It can be placed as . Figure 39 is a detailed view of the outer layer 140 , taken along section line BB in Figure 37 . As provided in Figure 39 , the outer layer 140 includes three reinforcing members 145 . In some embodiments, outer layer 140 includes only one reinforcing member 145 ( FIG. 40 ). In another embodiment, the outer layer includes up to eight reinforcing members 145 . If more than one reinforcing member 145 is used, the reinforcing members are evenly spaced around the circumference of the outer layer 140 . As further shown in FIG. 39 , reinforcement member 145 may have a straight shape (eg, rectangular) in cross-section. However, any other regular or irregular shape is also contemplated. For example, the reinforcing member may also be round in cross-section.

In a further aspect, the reinforcement member 145 has a finite width that is less than the circumference of the outer layer 140 . The total combined width (w) of the reinforcing members 145 may range from 5% to 50% of the circumference of the outer layer 140 . In another embodiment, the total combined width of the strips is about 5%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, or about It is 50%.

Figure 40 shows a partial view of the outer layer 140 of Figure 39 . As provided in Figure 40 , the circumferential width of reinforcement member 145 may range from 0.010 inches to 0.150 inches. In some embodiments, the distal end of outer layer 140 has a diameter of 0.200 inches, and the circumferential width of reinforcement member 145 may range from 0.010 inches to 0.150 inches. In some exemplary, non-limiting embodiments, the diameter of the outer layer at the distal end is about 0.200'' and the reinforcing member has a diameter of about 0.03'', about 0.035'', about 0.04'', about 0.045'', about 0.05''. '', about 0.055'', about 0.06'', about 0.065'', about 0.07'', about 0.075'', about 0.08'', about 0.085'', about 0.09'', about 0.095'', about 0.10 Examples of '', about 0.105'', about 0.110'', about 0.115'', about 0.120'', about 0.125'', about 0.130'', about 0.135'', about 0.140'', and about 0.145'' It may have a width of about 0.010'' to about 0.150'', inclusive. It will be appreciated that the foregoing widths are exemplary and that if the distal outer diameter of the elongated sheath has a size different from 0.200'', the strip widths may be adjusted to the same or different ratios. In another aspect, as described above, the width of the reinforcing member may be measured as a percentage of the outer layer circumference.

In embodiments where the reinforcing members 145 are present as one or more strips disposed circumferentially along the length of the outer layer 140 , the width of the reinforcing members 145 may be the same along the length, or may vary along the length. You will further understand that you can. In embodiments where the width of the reinforcing member 145 varies along the length of the outer layer 140 , such reinforcing member 145 may have any of the previously disclosed width values.

In another aspect, at least one reinforcement member 145 is configured to provide axial reinforcement to the outer layer 140 . In this exemplary embodiment, at least one reinforcing member 145 may be disposed along the length of outer layer 140 or along a portion of the length of outer layer 140 . In some embodiments, at least that portion of the length of outer layer 140 over which reinforcement member 145 is disposed is located at the distal end and/or proximal end of outer layer 140 . In another aspect, reinforcement members 145 may also be located anywhere along the length of outer layer 140 .

As previously discussed, and as shown in Figure 39 , the outer layer of sheath 140 is comprised of a first polymer layer 146 (disposed adjacent to the inner liner of the sheath) and a second polymer layer 147 (disposed on the interior of the sheath). disposed further from the liner and forming the outer layer of the outer layer of the sheath. However, it will be further understood that the outer layer may have both two-layer and three-layer configurations depending on location. In some embodiments, the layer formed by the second polymer may provide better abrasion resistance (e.g., between sheaths and calcified lesions) and better resistance to hydrophilic coating processes, while the layer formed by the first polymer is ( It contains more lubricant materials (e.g., to prevent the outer layer from sticking to the inner liner of the sheath during expansion), provides higher pressure resistance or resistance to ballooning, and hemostatic properties. In some embodiments, the layer formed by the first polymer ( 146 ) forms the inner surface of the outer layer ( 140 ), the layer formed by the second polymer ( 147 ) forms the outer layer of the sheath, and the reinforcing member ( 145) ) is disposed between the outer surface of the first polymer layer ( 146 ) and the inner surface of the second polymer layer ( 147 ).

In some embodiments, first polymer layer 146 may be comprised of Pebax or polyurethane with Shore 25D to 35D. In some embodiments, the first polymer layer 146 includes PTFE powder, an optional mineral filler, and an optional inorganic filler to reduce friction as the inner member 108 of the sheath expands by sliding against the outer layer 140 . Contains adhesion reducing additives. In some embodiments, the second polymer layer 147 of the outer layer 140 is a polyurethane or polyurethane/styrene block copolymer (SBC) having a Shore A hardness of less than about 60, such as a Shore A of about 55A. It consists of Neusoft 597-50A hardness. In certain embodiments, the first polymer layer 146 is comprised of a polyether block amide, such as Pebax, which has a Shore D hardness of less than about 35.

As provided in FIGS. 39 and 40 , reinforcement member 145 is at least partially embedded in first polymer layer 1 46 . In some embodiments, the thickness of reinforcement member 145 is less than the thickness of first polymer layer 146 . For example, as shown in Figure 40 , reinforcement member 145 has a thickness ranging from 0.0005 inches to 0.00155 inches. In some embodiments, reinforcement member 145 has a thickness of approximately 0.001 inches. In the exemplary configuration, reinforcement member 145 has a thickness of 0.001 inches and the first polymer layer has a thickness of 0.00154 inches. In another embodiment, not shown, the reinforcing member 145 has a thickness corresponding to the thickness of the first polymer layer 146 . In a further embodiment, the reinforcement member 145 has a thickness greater than the thickness of the first polymer layer 146 . In some embodiments, first polymer layer 146 and reinforcement member 145 are coextruded. Similarly, the first polymer layer 146 , the reinforcement member 145 , and the second polymer layer 147 are coextruded with the reinforcement member 145 positioned between the first and second polymer layers 146, 147. do. In another embodiment, the first polymer layer 146 is a reinforcing member 145 Provided above, the two components are bonded or fused together by at least one of heat or compression.

FIG. 41 shows a cross-sectional view of another exemplary outer layer in a resting (unexpanded) configuration, including one reinforcing member, taken along section line BB in FIG. 35 ;

As mentioned above, the reinforcement member 145 is made of a material that is stiffer than the main body portion of the outer layer 140 (first polymer layer 146 , second polymer layer 147 ) and also a material with a low coefficient of friction ( For example, high-density polyethylene). In some embodiments, reinforcement member 145 is comprised of a polymer that is compatible with the first and second polymer layers, including, for example, high hardness Pebax or polyurethane. Reinforcement member 145 may also be comprised of a material having a Shore D hardness ranging from 45D to 76D.

Additional examples of sheaths that can be used with the outer layers disclosed herein can be found in US Application No. 63/021,945, the contents of which are incorporated herein in their entirety.

Additional exemplary two-layer configurations are shown in Figures 42A-42C . In this configuration, for example, the reinforcing member may be part of an inner layer, wherein the reinforcing member has substantially the same thickness as the inner layer (see 4200 in FIGS. 42A and 42B ).

In some exemplary, non-limiting embodiments, if the two polymer layers of the outer layer are formed separately, a tie layer may be disposed between the two layers. It will be further understood that any of the disclosed tie layers may be used.

As discussed in detail above, an important function of the sheath is to have a clinically acceptable pressing force against all of the patient's anatomy.

To reduce pressing forces, various types of lubricants can be used. Some of the various lubrication types and methods are disclosed above. As disclosed, any of the disclosed lubricants (lubricating material, lubricating filler, lubricating liner) can reduce the frictional forces between the various layers of the sheath sliding against each other, thereby allowing the delivery system to open the sheath more easily. do. However, lubrication between the inner liner and the outer layer allows the outer layer to slide easily over the sheath shaft. When large portions of the outer layer slide together, the outer layer may bunch up at one point, thereby raising the outer diameter (OD), which is called agglomeration. This can result in difficulty inserting or retrieving the sheath and a more traumatic interaction with the blood vessels.

In certain embodiments, to avoid this problem, the outer layer can be bonded to the inner liner of the expandable sheath to prevent movement of the outer layer along the sheath shaft.

In certain embodiments, bonding of the inner liner and the outer layer may occur anywhere. In another aspect, such bonding may occur in areas of the sheath cross-section that are configured such that minimal elongation of the outer layer occurs during expansion. Joining is also performed in non-lubricated locations.

Accordingly, disclosed herein are aspects in which at least a portion of the innermost surface of the outer layer is bonded to at least a portion of the outermost surface of the inner liner. This exemplary embodiment is also shown in Figures 27A and 27B . It will be appreciated that such junctions may optionally exist in any of the disclosed cis configurations described above. Conjugation may be performed by any method known in the art. In some aspects, joining is performed by laser welding, compression joining, and/or optional ultrasonic welding.

In certain embodiments, bonding of the outer layer to the inner liner may occur on a cross-section of the sheath cross-section where the outer layer is not expected to overextend or move relative to the inner liner during expansion. In another exemplary, non-limiting aspect, the portion of the inner member immediately adjacent to the end of its outer layer meets these criteria. As shown in FIGS. 27A-27B , joint 2790 occurs between inner liner 2702 and outer layer 2708 at a portion that is not expected to overstretch or move relative to the inner liner. In this embodiment, lubricant 2707 is not applied to these locations on the inner liner to ensure good bonding between the two components. In this position, the outer layer can be bonded in place along the length of the sheath shaft to prevent longitudinal movement across the inner member. In another aspect, the outer layer can be bonded to the inner liner at a portion of the sheath. Because the joints as disclosed herein do not impede movement of the inner liner relative to the outer layer or stretching of the outer layer itself, the force required to expand the sheath is not adversely affected by the joints.

In another aspect, it will be appreciated that the joint location may be important in minimizing pressing forces. However, in other embodiments, the junction covers a relatively small portion of the sheath circumference. In another aspect, the method of manufacturing the joint needs to be accurately controlled and repeatability of the method needs to be ensured. Specific methods for manufacturing the joint are described in detail below.

In another aspect, two or more portions of the inner liner and outer layer may be bonded together. In this exemplary aspect, the junction may be formed in a predetermined pattern. In another aspect, the bonding pattern can be aligned to the lubricant pattern. In this aspect, bonding can be performed on any part of the sheath in the absence of lubricant.

It will be appreciated that when a sheath is used to deliver a prosthetic device into a patient's blood vessel, hemostasis may be impaired if blood from the patient's arteriotomy penetrates between the inner liner and the outer layer. In this scenario, the outer layer is the only cis element that resists blood pressure and maintains hemostasis.

The outer layer is typically formed of a material that allows for easy expansion of the inner liner, while an inward force can be applied to the inner liner to retract it to its original, non-expanded configuration. However, sufficiently high blood pressure can cause the outer layer to "balloon", which at some point may even rupture, compromising hemostasis. A schematic diagram of this phenomenon is shown in Figures 29a-b . An exemplary sheath 2900 with an inner liner 2902 and an outer layer 2908 is connected to the hub 2911 and inserted within the patient's anatomy 2913 . If hemostasis is not maintained, the outer layer has the potential to undesirably affect the patient by "ballooning" ( 2915 ).

For portions of the sheath below the level of the patient's skin, potential ballooning may be inhibited by tissue surrounding the sheath and resisting blood pressure, but for portions of the sheath outside the patient, this undesirable phenomenon may still occur. It can happen. The portion of the sheath that stays outside the patient's body varies and depends on the patient's size and anatomy as well as the doctor's preference.

Making the material of the outer layer sufficiently rigid to resist blood pressure and prevent ballooning increases the force required to expand the inner liner and thereby increase the force required to advance the delivery system through the sheath, creating unwanted stress. This can lead to trade-offs.

The embodiments described herein solve this problem and have minimal impact on the forces that expand the sheath while helping to prevent excessive outer layer ballooning of the portion of the sheath that remains outside the patient's body.

Embodiments described herein aim to reinforce the outer layer of the sheath along its proximal section without significantly affecting its ability to expand while the delivery system is pressed through the sheath. It is understood that in some embodiments described herein, the reinforcing portion of the outer layer may remain completely external to the patient's arteriotomy. However, in other embodiments, at least a portion of the reinforcement portion may be inserted into a blood vessel of a patient. Some example schematics of the disclosed embodiments are shown in Figures 29C-D , where reinforcement layer 3025 is disposed on outer layer 2908 and substantially prevents the “ballooning” effect. As shown in FIG. 29D , the reinforcing portion of the sheath may be long enough such that at least a portion of the reinforcing portion is inserted within the patient's anatomy 2913 .

In this aspect, reinforcement of the outer layer in the proximal portion of the sheath may be accomplished by disposing a reinforcing jacket having a proximal end and a distal end on at least a portion of the outer layer. As disclosed herein, a reinforcing jacket can include elastomeric materials and reinforcing elements. This reinforcing jacket is then placed on the proximal portion of the outer layer. In this aspect, the ends of the reinforcing jacket are substantially seamlessly joined to at least a portion of the outer surface of the outer layer. This smooth transition between the outer layer and the reinforcing jacket allows the sheath to be inserted into the patient's body.

In another aspect, the proximal end of the reinforcement jacket can be bonded to the proximal end of the outer layer. However, aspects in which the proximal end of the reinforcing jacket is not bonded to the proximal end of the outer layer are also disclosed.

In certain embodiments, the reinforced jacket has exemplary values of about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, and about 14 cm. It may have a length ranging from about 5 cm to about 15 cm.

In another aspect, the elastomeric material present in the reinforcement jacket can be any elastomer known in the art. In some embodiments, the elastomeric material includes polyether block amides, styrenic elastomers, polyurethanes, latex, copolymers thereof, blends thereof, or coextrudates thereof. In another aspect, the elastomer may include a silicone-based elastomer.

In another aspect, the elastomeric material has exemplary values of about 20A, about 25A, about 30A, about 35A, about 40A, about 45A, about 50A, about 55A, about 60A, about 65A, about 70A, and about 75A. It may have a Shore hardness of about 10A to about 80A, including.

In another aspect, the reinforcement jacket includes reinforcement elements. Some example schematics of various reinforcement jackets are shown in Figures 30A-B . The reinforcement jacket 3025 is seamlessly joined to the outer layer 3008 disposed on the inner liner 3002 at the distal end of the reinforcement jacket. The proximal end of the reinforcement jacket may or may not be bonded to the inner liner and/or hub 3011 . Reinforcing filaments 3027 are disposed within the elastomer. The reinforcing elements, which have a minimal effect on the resistance of the outer layer, expand to a certain diameter, at which point their resistance increases sharply.

When the delivery system is pushed through the sheath, it requires only a limited amount of expansion to accommodate the OD of the crimped valve. This limited expansion will not engage the reinforcing elements and will have minimal effect on the forces that expand the sheath to this point will be derived only from the low durometer elastomer. When ballooning begins, the diameters of the outer and reinforcing layers will increase only until the reinforcing elements become effective and excessive ballooning is prevented.

In certain aspects, the reinforcing element may include a plurality of filaments arranged in a braided configuration. In this aspect, the plurality of filaments may be disposed in a plurality of circumferential rows within the reinforcement jacket, where each of the plurality of filaments has a sinusoidal shape or any irregular shape, or any combination thereof. In certain aspects, the braid or coil may be an expandable braid or coil.

In yet a further aspect, the plurality of filaments may include stainless steel, nitinol, polymeric materials, or composite materials. In certain non-limiting aspects, the filament may include nitinol and/or other shape memory alloys. In another non-limiting aspect, the filament may include polyester or nylon. In another exemplary embodiment, the filaments may include spectra fibers, polyethylene fibers, aramid fibers, or combinations thereof.

Some example embodiments of braid or coil configurations are shown in Figures 4A-4D . In certain aspects, the braid or coil may generally be a thin, hollow, substantially cylindrical tube comprising an arrangement, pattern, structure or configuration of filaments or struts, although other geometries may also be used. Suitable filaments are circular, having a diameter of less than about 0.015", less than about 0.01", less than about 0.008", less than about 0.005", less than about 0.002", less than about 0.001", less than about 0.0008", or less than about 0.0005". It can be. In another aspect, a suitable filament may be circular and have a shape of about 0.0006", about 0.0007", about 0.0008", about 0.0009", about 0.001", about 0.002", about 0.003", about 0.004", about 0.005", about From about 0.0005" inch thick to about 0.015" thick, including example values of 0.006", about 0.007", about 0.008", about 0.009", about 0.01", about 0.012", about 0.013", and about 0.014". In another embodiment, suitable filaments may have diameters of less than about 0.006", less than about 0.005", less than about 0.004", less than about 0.003", less than about 0.001", less than about 0.0009", less than about 0.0008". , less than about 0.0007", less than about 0.0006", and about 0.0005". In another aspect, the flat filaments may have a height of about 0.004", about 0.005", about 0.006", about 0.007", about may have a width greater than about 0.003" to about 0.015", including exemplary values of 0.008", about 0.009", about 0.01", about 0.012", about 0.013", and about 0.014". However, other geometries The structure and dimensions are also suitable for specific embodiments.

In further aspects, the braid may have a coefficient of intersection per inch (PIC) of less than 50, less than 40, less than 30, less than 20, or less than 10. In another aspect, the braid may have a PIC coefficient of 10 to 2, with example values of 9, 8, 7, 6, 5, 4, and 3. In yet a further aspect, the PIC may vary along the longitudinal axis of the lumen. In another aspect, the braid pattern can vary along the longitudinal axis of the lumen. In embodiments where the braid or coil includes filaments that are nitinol, the nitinol is heat set at the expanded diameter ( d _e ). In another embodiment where the filament comprises stainless steel or nitinol, the filament is configured to be atraumatic at least at the distal end of the sheath. 4A-4D show partial elevation views of various structures for the braid or coil 28 . It is understood that the structure of the braid or coil 28 varies along the length of the sheath and may vary from section to section. 4A-4D are not necessarily drawn to scale and represent illustrative and non-limiting embodiments only. It is further understood that the braid or coil is configured to provide torque properties of the sheath during insertion of the prosthetic device.

However, in other embodiments, the reinforcing element may include wires disposed in a plurality of circumferential rows embedded within an elastomeric material. In this aspect, the wire can have any shape configured to expand or contract. For example, the wire may have a sinusoidal or wavy shape. The phase and amplitude of the wire can vary depending on the desired application. Additionally, it will be appreciated that the frequency and total number of circumferential rows present in the elastomeric material may also vary depending on the desired application. The expansion of the wire continues to expand the outer layer of the sheath until the reinforcing elements present in the elastomeric material are tightened. In this configuration, the reinforcing jacket arrests further expansion and thus maintains hemostasis.

In another aspect, a tie layer may be disposed between the reinforcement jacket and the outer layer of the sheath.

Additional configurations of the reinforcement jacket are also disclosed. In this embodiment, the outer layer does not extend to the proximal end of the sheath, and at least a portion of the inner liner at the proximal end of the sheath is substantially free of the outer layer. This proximal portion of the sheath not covered by the outer layer may be of any length. In some embodiments, the proximal portion includes exemplary values of about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, and about 14 cm. It may be about 5 cm to about 15 cm.

The proximal portion of this outer layer can be bonded to the inner liner to ensure that no space exists between the inner liner and the outer layer when the sheath is inserted into the patient's body. This bonding can also prevent the outer layer from sliding when the sheath is inserted into the patient's body. In this aspect, a reinforcing jacket having a proximal end and a distal end is then positioned over at least a portion of the outer surface of the inner liner at the proximal end of the sheath substantially free of the outer layer. In this configuration, it is understood that the proximal end of the reinforcement jacket abuts the proximal end of the sheath and is at least partially bonded to at least a portion of the proximal end of the outer surface of the inner liner.

Again, the reinforcing jacket can have a length substantially similar to the length of the proximal portion of the sheath without the outer layer. In some exemplary, non-limiting embodiments, the length of the reinforcement jacket is about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, and about 14 cm. It may be from about 5 cm to about 15 cm, including exemplary values of cm.

In another aspect, the distal end of the reinforcement jacket abuts or at least partially overlaps the proximal portion of the outer layer. It is further understood that the distal end of the reinforcement jacket is seamlessly joined to at least a portion of the proximal portion of the outer surface of the outer layer. As described in this aspect, it will be appreciated that the reinforcing jacket may include all of the components of the previously disclosed reinforcing jacket.

In another aspect, a sheath having any of the above-described configurations and comprising a balloon guard is also disclosed. Similar to the reinforcing jacket described above, the balloon guard is configured to accommodate different insertion depths of the sheath while preventing excessive outer layer ballooning on portions of the sheath that remain outside the patient's body and without affecting the forces that expand the sheath. The balloon guard is configured to remain outside the patient's body and not be inserted into the patient's anatomy.

In aspects disclosed herein, the balloon guard has a proximal end and a distal end, is disposed over at least a portion of the outer layer, and the balloon guard is configured to remain external to the subject's blood vessel and substantially maintain hemostasis.

As described in this disclosure, the balloon guard can be collapsed. In another aspect, the balloon guard can be configured such that its length can be adjusted based on the insertion depth of the sheath.

In some embodiments, the inner diameter of the balloon guard can be sufficiently large or have minimal resistance to expansion up to a certain diameter so as not to affect the forces expanding the sheath or advancing the delivery system through the sheath. When the balloon guard reaches a certain diameter, the force to expand the balloon guard increases significantly, which can resist blood pressure and stop ballooning. It is understood that the balloon guard may not prevent the initiation of ballooning, but may contain the outer layer to prevent overinflation, rupture, and impair hemostasis. Some example schematics of balloon guards are shown in Figures 29E-29F . The balloon guard 3125 has an outer layer 2908 such that blood 2915 can enter the portion between the outer layer 2908 and the inner layer 2902 , but without causing rupture of the sheath and assists in maintaining hemostasis. placed above.

In another aspect, the proximal end of the balloon guard is connected to the hub and/or the most proximal portion of the outer layer of the sheath. The distal end of the balloon guard radially surrounds at least a portion of the outer layer, but the distal end is not bonded to the outer layer. As described herein, it is understood that the balloon guard seals against the subject's skin and does not insert into the subject's anatomy ( 2913 ).

In another aspect, the balloon guard may include a braid or coiled sleeve containing a plurality of filaments. Any one of the plurality of filaments disclosed above may be used. In some embodiments where a braided or twisted sleeve is present, at least a portion of the plurality of filaments at the distal end of the balloon guard are coupled together to allow shortening of the braided or twisted sleeve, relative to the outer layer and relative to the skin of the patient. Provides sealing.

In another aspect, the braid or coiled sleeve may also include a polymer. Any of the disclosed elastomers described above may be used. In certain embodiments, the braid or coil may be embedded with a polymer. It will be appreciated that the braid or coil material may be any material known in the art. In certain aspects, the braid or coil material may include a metal or metal alloy. In certain aspects, any known metal or metal alloy used in medical devices can be used to make the braid or coil. In some aspects, the braid or coil may be made from a shape memory material. In another aspect, the braid or coil can be any of the braids or coils as disclosed herein.

In another aspect, the braid material can include a polymer. It will be appreciated that any polymer known in the art may be used to form the braid. In this exemplary, non-limiting embodiment, the polymer may comprise any known polyolefin, any known polyamide, or any known polyester. In another aspect, the braid material can include a fabric. In another aspect, the braided sleeve can include fabric. However, in yet a further aspect, the balloon guard may comprise an e-PTFE tube, and the balloon guard comprises an e-PTFE tube, a corrugated tube, or any polymer tube having a shape configured to be compressed. In certain aspects, the balloon guard may include e-PTFE tubing. In this exemplary, non-limiting aspect, the e-PTFE tube can be compressed without losing its shape. In another aspect, the balloon guard may include a corrugated tube. The corrugated tube allows the guard to be compressed and its length adjusted.

In this exemplary, non-limiting aspect, the balloon guard may be made of any polymeric material that can be shaped to allow such material to be compressed. For example, the tube may be formed from any polymer known in the art. The walls of these tubes can be cut in patterns that allow them to be compressed without losing their initial shape.

Additionally, some aspects of any of the sheath configurations disclosed herein may include an external hydrophilic coating on the external surface of the outer layer. This hydrophilic coating may facilitate insertion of any of the sheaths disclosed herein into a patient's blood vessel. Examples of suitable hydrophilic coatings include Harmony ^™ Advanced Lubricity Coating and other Advanced Hydrophilic Coatings available from SurModics, Inc. (Eden Prairie, MN). DSM medical coatings (available from Koninklijke DSM NV, Heerlen, the Netherlands) and other coatings (e.g. PTFE, polyethylene, polyvinylidine fluoride) are also suitable for use in sheaths.

Additionally, as shown in Figure 11 , soft tip 102 may be used with any of the sheath configurations disclosed herein. In certain embodiments, the tip may comprise low density polyethylene (LDPE) and may be configured to minimize trauma or damage to the patient's blood vessels as the sheath is navigated through the vascular system. For example, in some aspects, the soft tip portion 102 may be slightly tapered to facilitate passage through blood vessels. The soft tip portion 102 may be secured to the distal end 104 of the sheath 100 , such as by thermally bonding the soft tip portion 102 to the inner and outer layers of the sheath 100 . These soft tips 102 may be provided with lower hardness than other parts of the sheath 100 . In some embodiments, the soft tip 102 may have a Shore hardness of about 25 A to about 40 A, including exemplary values of about 28 A, about 30 A, about 32 A, about 35 A, and about 38 A. You can. It will also be understood that Shore hardness can have any value between any two of the preceding values. In another aspect, the soft tip 102 has a Shore hardness of about 25 D to about 40 D, including exemplary values of about 28 D, about 30 D, about 32 D, about 35 D, and about 38 D. You can have it. The tip portion 102 is configured to be radially expandable to allow the prosthetic device to pass through the distal opening of the sheath 100 .

As shown in Figure 11 , sheath 100 optionally has at least one radiopaque filler or marker, such as a discontinuous or C-shaped band 112 positioned near the distal end 104 of sheath 100. It can be included. Marker 112 may be associated with the inner liner and/or outer layer 108, 110 of sheath 100 . Such radiopaque tip markers may include materials such as suitable radiopaque fillers, platinum, iridium, platinum/iridium alloys, stainless steel, other biocompatible metals, or combinations thereof. Materials suitable for use as radiopaque fillers or markers include, for example, barium sulfate, bismuth trioxide, titanium dioxide, bismuth subcarbonate, or combinations thereof. The radiopaque filler may be mixed with or embedded within the layer of elastomeric polymer used to form the outer layer, and may be about 10%, about 15%, about 20%, about 25% by weight of the outer polymer tubular layer. It may comprise from about 5% to about 45% by weight of the outer layer, including exemplary values of weight%, about 30% by weight, about 35% by weight, and about 40% by weight. Depending on the particular application, more or less radiopaque materials may be used in some embodiments.

The sheath disclosed herein may be configured to expand locally at specific locations corresponding to the location of the medical device along the length of the lumen and then locally retract once the medical device passes that specific location. Accordingly, a bulge may be visible as a medical device is introduced through the sheath and moves longitudinally along the length of the sheath, exhibiting continuous localized expansion and contraction as the device moves the length of the sheath. In some embodiments, each segment of the sheath can locally retract and return to the original resting diameter ( d _r ) of the lumen after removal of any radial outward (insertion) force.

In some embodiments, each segment of the sheath can locally retract after removal of any radial outward force to at least partially return to the original resting diameter ( d _r ) of the lumen.

44-66 disclose an example of an expandable sheath 4400 and a method of making the same, including a proximal section 4402 and a distal tip section 4404 that can be permanently divided to facilitate retrieval of the medical device. do. Sheath 4400 defines a lumen 4406 extending therethrough for passage of medical devices such as those described above. For example, the proximal section 4402 may include a scrolled or helically expanded inner liner layer 4408 with slits therebetween, allowing its edges to overlap. Under bias from the surrounding elastomeric jacket or outer layer 4410, the inner liner layer 4408 expands and folds locally as the medical device passes through it. The tip section 4404 extends from the distal end 4416 of the proximal section 4402 and, in some cases, defines a slit 4412 extending most of the length of the tip section except for the distal end 4422 of the tip section. do. Slit 4412 also extends through most or all layers of tip portion 4404. In this way, the portion of lumen 4402 defined by tip section 4404 may be expanded by passage of a medical device therethrough.

Advantageously, the slit 4412 in the tip section 4404 provides a low pressing force for opening, less than about 25 newtons (5.6 pound-force), or in another aspect, less than about 15 newtons (3.4 pound-force); It remains open to facilitate recovery of part or all of the medical device, if necessary. The elastomeric outer layer 4410 extends over all or a portion of the tip section, smoothes the surface, and contributes to maintaining the hemostatic and atraumatic properties of the tip section 4404. Additionally, the expandable sheath 4400 may include a radiopaque marker 4428 embedded in the tip section 4404 to improve positioning of the expandable sheath, as shown in FIG. 66 .

44-46 , for example, proximal section 4402 includes an elongated body 4418 extending between proximal end 4414 and distal end 4416. Elongated body 4418 defines the proximal portion of lumen 4406 extending through expandable sheath 4400. Tip section 4404 extends distally from distal end 4416 of proximal section 4402. Tip section 4404 includes a proximal end 4420, a distal end 4422, and a generally tapered tip body 4424 extending between the proximal end 4420 and the distal end 4422. Tip body 4424 defines a distal portion of lumen 4406 that extends through expandable sheath 4400.

The tip section 4404 extends and/or coats at least the inner liner layer 4408 and the inner liner layer, defining a slit 4412, to form a tip section such as the outer (jacket) layer 4410 and/or the middle layer 4426. It contains several relatively soft structures that make the section atraumatic. In general, in some embodiments, the outer layer 4410 prevents blood loss through the inner liner layer 4408 and extends over the proximal portion 4402, thereby forming the scroll inner liner layer 4408 as described in more detail above. Deflects towards compressed composition. In another aspect, middle layer 4426 can be used to bond inner liner layer 4408 to outer layer 4410. (Middle layer 4426 may be the only thing holding tip section 4404 together.) Middle layer 4426 may also mediate blood loss through inner liner layer 4408. The middle layer 4426 may include two or three layers, including its own sub-layers, such as tie layers. Unlike numbered layers, most or all layers of tip section 4404 can be completely slatted for reduced pressing forces and cleaner, better-defined expansion or splitting conditions, as shown in Figures 47-48. can be sealed (and easily sealed by thermal reflow).

The atraumatic tip section 4404 has a lubricating liner, such as a high-density polyethylene (HDPE) inner liner layer 4408, and an intermediate jacket comprised of a copolyamide, such as, for example, polyether block amide (Pebax) outer layer 4410. (4426) can be used in any catheter that benefits from thermal bonding with good adhesion. In some cases, the middle layer is the atraumatic portion of the tip because it extends most distally as a single layer.

The inner liner layer 4408 may be an extension of the same layer in the proximal section 4402 that performs a “scroll” function with the free edge defined by a spiral elongated slit that expands and contracts during passage of the medical device. The inner liner layer 4408 may have a generally stiffer composition than the other layers, for example, polyethylene such as high-density polyethylene (HDPE) or low-density polyethylene (LDPE) and other relatively rigid and/or lubricant materials described herein. It may be composed of a phosphorus polymer.

The inner liner layer 4408 in the tip section 4404 can be produced by modifying the distal end of the scrolled inner liner layer in the proximal section 4402. For example, as shown in Figure 49 , the manufacturer cuts the inner liner layer 4408 into two separate cuts. The first cut 4444 extends proximally from the distal edge 4432 of the inner liner layer 4408. The second cut 4434 extends from the proximal end of the first cut 4444 perpendicular to one of the pair of lateral edges 4436 of the inner liner layer 4408. These two cuts form a flap 4438 that is rolled back into a scrolled configuration, as shown in FIGS. 50-52 . Cuts 4444, 4434 are positioned to define a portion of slit 12 through inner liner layer 4408. In particular, the first cut 4444 is positioned to align with the lateral edge 4436 opposite the flap 4438 in the radially inner portion of the scrolled configuration. Accordingly, the inner liner layer 4408, even in the folded state, does not block the slit 12 from extending into the lumen 4406, as shown in FIGS. 51 and 52 .

Flap 4438 can have different sizes and shapes depending on the size and shape of expandable sheath 4400, which in turn is related to the size, shape and nature of the medical device being passed through. However, for stented heart valves and similar devices, first cut 4444 may extend proximally about .157 inches (4 mm) and medially about .5 inches (12.7 mm) from lateral edge 36. ) can be located. The second cut 4434 extends .485 inches (12.3 mm) toward the lateral edge, leaving about 0.015 inches (.38 mm) so that it can be connected to the remainder of the inner liner layer 4408 without cutting the flap. there is. Accordingly, the flap has rectangular dimensions of approximately 4 mm and 12 mm. The width of the inner liner layer 4408 between the lateral edges 4436 is about 1.068 inches (27.1 mm), so the flap is about 40% to 50% of the width of the inner liner layer. The first cut 4444 will generally extend about 4 mm to 6 mm, or about two-thirds of the final length of the tip section 4404 when fully formed.

In some cases, additional or excess portions of inner liner layer 4410 may be trimmed as part of forming tip section 4404. For example, additional small (2 mm to 3 mm or about 2.5 mm) rectangular pieces can be removed from distal edge 4432 as shown in FIG. 53 to facilitate conical or tapered shaping. As described above for other aspects, the inner liner layer 4410 comprising the proximal section 4402 may include a lubricant to facilitate relative movement of the layers during expansion and contraction. However, tip section 4404 typically will not contain lubricant as it will be reflowed to form a unitary structure.

As shown in Figures 54-57 , the inner liner layer 4408 configuration of Figures 50-52 can be mounted on a mandrel or heated die, reflowed (with the application of heat) into a tapered cone shape, and then ( It can be trimmed to provide a relatively flat distal end (as shown in Figure 67 ). In this intermediate configuration shown in FIG. 54 , tip section 4404 extends about 4 mm beyond the distal end 4416 of proximal section 4402. Additionally, the slit 4412 extends the entire length of the tapered cone shape. Additionally, it should be noted that the proximal section 4402 still maintains a scroll configuration with the elongated edge 4440 for free expansion and retraction as described above. The two slits 4412 and 4440 are circumferentially offset from each other by about 44 degrees to 120 degrees, or in some embodiments by 70 degrees to 120 degrees. The wider range reflects, for example, the aspect of a sheath with a greater overlap of the rolled inner liner. Greater overlap facilitates passage of larger medical devices, such as larger heart valves. However, as shown in FIG. 56 , at the portion of the inner liner layer 4408 that overlaps at the distal tip section 4404, the scrolled inner liner layer reflows to form a unitary wall structure. In particular, the wall structure is thicker when the reflowed inner liner layer 4408 has the overlapping configuration in Figures 50-52 and thinner at the end of the flap 4438 when there is only a single layer of thickness. The wall thickness of the distal end of inner liner layer 4408 is reduced by heating at its thinnest point to less than .005 inch (.13 mm) over a circumferential length of approximately .080 inch (2 mm).

As shown in the plan view of FIGS. 56-57 , slit 4412 narrows somewhat due to reflow, and adjacent overlapping layers of inner liner layer 4408 reflow together to form a single wall thickness. However, because the inner liner layer 4408 does not reflow proximal to the tip section 4404, the overlapping scroll configuration in the proximal section 4402 remains visible. In this way, the ability of the inner liner layer 4408 to expand and contract in the proximal portion 4402 of the expandable sheath 4400 is preserved.

58-62 and 67 , in one aspect, the next step in manufacturing the tip section 4404 is applying the intermediate layer 4426 to the shaped and trimmed inner liner layer 4408 of FIGS. 54-57 . It's a step. Middle layer 4426 facilitates connection of inner liner layer 4408 and outer layer 4410 and is formed of a relatively soft thermoplastic material that is atraumatic. (In other embodiments, middle layer 4426 is not needed, and layers 4408, 4410 can be coupled to each other through reflow, adhesives, mechanical fasteners, etc.) Middle layer 4426 can also be used at lower temperatures. By reflowing and providing a larger bond area to the elastomeric outer layer 4410, bond strength is improved. Another advantage is that the middle layer 4426 can provide a more lubricant inner diameter to the tip section 4404 for easier placement and retrieval of the medical device. The intermediate layer 4426 may also impart some structural rigidity to the distal end 4422 and may allow the distal end to undergo deformations such as ovulation or “fish mouth formation.”

In one aspect, middle layer 4426 extends distally beyond inner liner layer 4408 and outer layer 4410 by about 0.040 inch (or 2 mm to 3 mm). In another aspect, middle layer 4426 extends up to about 0.080 inches distal to layers 4408, 4410. Because middle layer 4426 is less rigid than inner liner layer 4408, middle layer 4426 can bend more easily due to axial forces than inner liner layer 4408.

Middle layer 4426 may be a cylindrical single layer, such as with a tie layer of about .012 inches (.3 mm) and an internal diameter of about .199 inches (5 mm), as shown in Figure 68 . The middle layer 4426 may have several sub-layers, such as a double or triple layer, as shown in FIG. 69 . For sub-layers, the tube formed from the middle layer 4426 can be coextruded. The material for the middle layer 4426 and its (optional) sublayers is a thin polymer tube in a heat-sealable tie layer, such as Orevac 18440M (maleic anhydride modified LLDPE), Orevac 9318, or Orevac 9444 (maleic anhydride modified EVA), or Includes membrane. These can be the middle sub-layer within a three-layer or the outer layer in a two-layer configuration.

Referring again to Figures 58-59 , middle layer 4426 is disposed over the distal end of cone-shaped inner liner layer 4408. The middle layer 4426 is then heated and flowed downward, coating the molded inner liner layer 4408 to form the structures shown in FIGS. 60-62 and 67 . Additionally, or alternatively, middle layer 4426 may be heat-shrinked onto inner liner layer 4408. Advantageously, reflowing the middle layer 4426 does not require the use of a mandrel - it flows over the already shaped surface of the inner liner layer 4408.

In another aspect, as shown in FIG. 67 , middle layer 4426 is not completely melted over inner liner layer 4408. Instead, it extends beyond inner liner layer 4408. For example, the heat sealable tip tube is cut to about .250 inch (6.35 mm) long, and about .160 inch (4 mm) of the heat sealable tip tube is cut into a .160 inch (4 mm) long thinned HDPE inner liner layer. Overlapping with 4408 leaves several millimeters of middle layer 4426 extending beyond inner liner layer 4408. This extension can then be trimmed past the inner liner layer 4408 to a 1 mm to 2 mm tip. Additionally, this extended length of the tip section 4404 can be cut or measured again to refresh and extend the slit 4412 through the intermediate layer 4408, approximately at the distal end 4402 of the tip section 4404. It can be extended to within .040 inch (1 mm) or .080 inch (2 mm) as needed. (In particular, this additional 1 mm to 2 mm remains uncovered by the outer layer 4410 when this outer layer is used.)

In another aspect, middle layer 4426 may include two sub-layers. For example, the thermally bondable tie sublayer can be formed by coextrusion with an HDPE or LDPE inner sublayer. In one embodiment, the inner sublayer may have an internal diameter of approximately .199 inches and a thickness of .010 +/- .001 inches, and may be comprised of LDPE or HDPE. The outer sublayer is .002 +/- .0005 inches and is comprised of tie layer material.

In another aspect, the middle layer 4426 may include two sub-layers, such as an Orevac 18440M outer sub-layer to be bonded to the elastomeric outer layer 4410 and an LDPE inner sub-layer to be bonded to the inner liner layer 4408. You can. The Orevac layer may have a thickness of approximately .002 inches, while the LDPE layer may have a greater thickness, such as .010 inches. For example, joining the middle layer to FEP heat shrink tubing can be done at 450 degrees Fahrenheit for about 1 minute.

In another aspect, the outer sub-layer may include Pebax 45D (Shore D) and an inner sub-layer of Orevac. The Orevac internal sub-layer may have an inner diameter of approximately .200 inches and a thickness of .006 inches. The Pebax 45D outer sub-layer may also have a wall thickness of approximately .006 inches. The outer sub-layer can be thermally bonded to an outer elastomeric layer 4410, such as the outer layer of Pebax 25D. The inner sub-layer may be thermally bonded to an inner liner layer 4408, such as an inner layer of HDPE.

As shown in FIG. 69 , in another aspect, the middle layer 4426 may include three sub-layers: an outer sub-layer 4442, a middle sub-layer 4444, and an inner sub-layer 4446. The inner sub-layer may have a larger diameter than the middle and outer sub-layers 4444 and 4442. For example, inner sublayer 4446 can have a thickness of about .006 to .008 inches, middle sublayer 4444 can have a thickness of about .002 to .003 inches, and outer sublayer ( 4442) may have a thickness of approximately .002 to .003 inches. The inner sublayer 4446 may be comprised of a lubricant or relatively rigid polymer, such as HDPE or LDPE. Middle sublayer 4444 may be comprised of a tie layer material. The outer sublayer 4442 may be comprised of approximately Pebax 25D to 45D.

In another aspect, inner sub-layer 4446 can have a thickness of about .005 inches with an inner diameter of .200 inches, middle sub-layer 4444 can have a thickness of about .002 inches, and outer sub-layer 4444 can have a thickness of about .002 inches. Layer 4442 may have a thickness of approximately .005 inches. The inner sublayer 4446 may include LDPE, for example. The middle sublayer 4444 may include Orevac and the outer sublayer 42 may include Pebax 45D. Although the various layers disclosed herein for the middle layer 4426 can be mixed to form different combinations of thicknesses and materials, the LDPE of the inner sublayer 4446 bonds well to the HDPE inner liner layer 4408, and Pebax 45D The outer sublayer 4442 is well bonded to the Pebax 25D outer layer 4410. Additionally, the LDPE inner sublayer 4446 allows the tip section 4404 to be easily removed from the stainless steel shaped mandrel.

In another embodiment, middle layer 4408 includes an LDPE inner sublayer 4446 having an internal diameter of .200 inches and a wall thickness of .006 inches, an Orevac middle sublayer 4444 having a wall thickness of .003 inches, and a wall thickness of .006 inches. and a Pebax 25D outer sublayer 4442 that is .003 inches. In particular, for this embodiment, the inner sublayer has twice the thickness of the other sublayers.

In another aspect, the middle layer 4426 can be formed from a multi-layer coextrusion of an HDPE or LDPE inner sublayer 4446, a middle thermally bondable tie sublayer 4444, and a Pebax 25D or 35D outer sublayer 4442.

The tie sublayer between the Pebax and LDPE sublayers may be Orevac. Alone and in combination, other tie layers such as functionalized olefins, such as maleic anhydride grafted ethylene vinyl acetate, polyolefins modified with acrylic acid, and other polar functional groups can also be used.

As a further aspect, the tip section 4404 of the expandable sheath 4400 may also include a radiopaque marker 4428. As shown in FIG. 66 , tip section 4404 supports marker 4428 very close to the tip, within a 6 mm length of the marker, for example, in an embodiment for delivering a stented heart valve. Having a marker in the tip section 4404 facilitates more accurate positioning of the medical device.

63-65 schematically depict one embodiment incorporating a radiopaque marker 4428 into the tip section 4404. In particular, a marker may be incorporated into the inner liner layer 4410 beneath the flap 4438. As shown in FIG. 63 , when the inner layer is cut to the shape of FIG. 48 , markers may be placed before flaps 4438 are folded back over the inner turns of inner liner layer 4410. 54-57 , for example, a reflow process and/or a heat shrink process (with an intermediate layer 4426) may encapsulate the radiopaque marker 4428 into the inner liner layer. . This also contributes to the thick wall portion of inner liner layer 4408 shown in FIG. 56 . Advantageously, the additional step of heat shrinking middle layer 4426 and outer layer 4410 can further secure radiopaque marker 4428. 64-65 show , in another embodiment, heat shrinking and trimming the middle layer 4426 to form another 1 to 2 mm tip and applying an outer jacket layer 4410 to form the distal end of the tip section 4408. shows that The radiopaque marker is shown in Figures 63-64 not yet folded into the inner liner layer 4408, illustrating its relative positioning during the assembly process.

In another aspect, a radiopaque marker may be bonded between middle layer 4426 and inner liner layer 4408 or between outer layer 4410 and middle layer 4426. In any case, having a radiopaque marker in the tip section 4404 facilitates positioning of the expandable sheath 4400 by allowing more accurate visualization.

Generally, radiopaque marker 4428 has a rectangular shape and bends into a C shape when folded into tip section 4404. In one aspect, as shown in FIG. 63 , the radiopaque marker has an axial length of about 2.5 mm and is axially centered below flap 4438, e.g., on the inner liner layer of tip section 4404. (4408) leaving .75 mm on each side for a 4 mm length, or 1.25 mm on each side for a 5 mm length. As shown in FIG. 64 , middle layer 4426 overlaps trimmed and shaped inner liner layer 4408 by about 1-2 mm and extends distally about 2-3 mm. As shown in FIG. 65 , an outer layer 4410 is applied to cover about 1 mm of the middle layer 4426, with the distal portion of the middle layer trimmed to about 1-2 mm.

44-46 , in one aspect, the outer elastomeric layer 4410 is the inner liner layer 4408 and the middle layer of both the proximal section 4402 and the distal section 4404 of the expandable sheath 4400. (4426) extends upward. For example, as shown in Figure 65 , outer layer 4410 is rolled, leaving about .040 inch to .080 inch (1-2 mm) of the tip uncovered at the distal end of sheath 4400. The inner liner layer 4408 is slid over the entire length of the tip section. Typically, the thickness of outer layer 4410 is about .005 inches. The outer layer may also have a taper to adapt to the shape of the proximal and tip sections 4402, 4404. A taper can be formed into FEP HS tubing via heat shrink, for example over a tapered mandrel.

The outer elastomeric layer 4410 may be a single layer, such as a polyurethane layer, or may include multiple sublayers. For example, the elastomeric layer may include two sublayers, such as an inner layer of low durometer PEBA, such as Pebax from Arkema, with a Shore D hardness of about 25 to less than 35. In another aspect, outer layer 4410 may have a Shore D hardness of 35 to 65. The outer layer may include a low durometer polyurethane having a Shore A hardness of about 65 to less than 75. One example of this is Neusoft 597-50 from NEU Specialty Engineered Materials.

In another aspect, outer elastomeric layer 4410 may be Neusoft 55A that slides across the entire length of rolled inner liner layer 4408 leaving the distal tip of middle layer 4426 exposed. The layers are then heat-shrinked for bonding. In one aspect, outer layer 4410 may be bonded directly to inner liner layer 4408, such as when the outer layer is comprised of Neusoft and the inner liner layer is comprised of HDPE. Additionally, the outer layer 4410 can be pulled over the middle layer 4426 at the tip section 4404, and the FEP shrink tube can be slid over the outer layer to thermally bond the outer layer to the middle layer.

In another aspect, elastomeric layer 4410 may be comprised of Pebax 25D and may be slid over middle layer 4426 to facilitate thermal bonding of the tip section layer. As described above, an optional lubricant, such as Nusil, may be applied to the outer surface of the inner liner layer 4408 to facilitate expansion and contraction of the inner liner layer 4408. However, in general, tip section 4404 will have no lubricant due to thermal bonding of the layers.

In another aspect, elastomeric layer 4410 may include a radiopaque filler, such as barium sulfate, for one layer or multiple sublayers.

As described above for expandable sheath 4403 for cardiovascular applications, such as delivery of stent-loaded heart valves, slit 4412 has a length of approximately 3.8 mm to 4 mm and is located at the distal end of tip section 4404. It has a short stop of 1 to 3 mm, in one embodiment 2 mm, from the end. Accordingly, slit 4412 is approximately 60% to 80% of the length of tip section 4404. (The unslitted length is 20% to 40% of the length of tip section 4404.) As shown in FIGS. 45-46 and 65-66 , for example, the slits may be linear in shape and have gaps. Alternatively, it can be partially sealed by reflow at various stages of construction, depending on how the manufacturer wishes to control the pressing force needed to tear open the tip section 4404. In other aspects, outer layer 4410 and middle layer 4426 may be split together in a single step, such as at the end of a manufacturing process.

The depicted embodiment has only a single linear slit 4412, but the shape and number of slit(s) can vary depending on how much or little pressing force is required. In general, more slits will reduce the pressing force. The slit can also have a shape that is wider at some points and narrower at other points, for example if less pressing force is needed at the proximal end 4420, and the slit can be wider or bifurcated into two slits. . Alternatively, two shorter slits may be used. Additionally, the pressing force can be further increased by reducing the width or length of the slit, such as tapering or reflowing the distal end of the slit 4412. The slits also do not have to be linear, but can be helical, branched, contain a series of extended gaps, etc. However, overall, the purpose is to facilitate retrieval of the medical device by passing the end of the expandable sheath 4400 and/or rupturing the tip section 4404.

Tip section 4401 is permanently altered during expansion by elongation of slit 4412 by rupturing open distal end 4422 through intermediate layer 4426. For example, tip section 4404 may transition from a tapered shape with a smaller first diameter to a more expanded diameter after passage of the medical device. The first inner diameter may be, for example, about 4.7 mm or 0.184 inches. The expanded second inner diameter may be from about 5.5 mm or .216 inches to about 9.0 mm or 0.354 inches, depending on the outer diameter of the valve mounted and disposed on the valve delivery system, for example, if the medical device is a heart valve. .

As shown in FIG. 47 , the slit 4412 may have a U-shape, where the rounded portion is on the proximal end and then the arms extend distally, and these arms are extensions of the tip section 4404. separated while In particular, the U shape has a relatively smooth and clean perimeter to facilitate placement and retrieval of the medical device. 48 illustrates how removal of the expanding force of the medical device causes the slit 4412 to contract somewhat due to the elasticity of the layers of the tip section 4404. However, the tip section remains substantially more receptive to retrieval due to the rupture and also some remaining open opening of the distal end 4422. FIG. 48 also illustrates how, in one aspect, a layer of interest can shrink by a different amount, such as inner liner layer 4408 shrinking more than outer layer 4410 or vice versa.

A method of delivering a medical device includes disposing at least a distal end of the expandable sheath 4400 within a blood vessel of a patient. As described above, radiopaque marker 4428 is adjacent distal end 4422 of tip section 4404. The marker allows the medical technician to approximate the location of the distal end 4422 by observing the location of the radiopaque marker 4428. Radiopaque markers can be viewed by medical technicians through devices such as x-ray devices. A radiopaque marker is advanced axially and aligned at a desired location within a blood vessel, such as a calcified aortic valve. The medical device is advanced distally through sheath 4400, expanding lumen 4406 to accommodate the size of the medical device.

As the medical device passes through the tip section 4404, the tip expands radially by expanding the slit 4412 and rupturing the distalmost end of the tip section, as shown, for example, in Figure 47 . Once the medical device has passed the distal end 4416 of the tip section 4404 and the slit 4412 extends axially through the distal end 4422 of the tip section 4404, the distal end of the sheath 4400 The diameter in is partially contracted to a diameter that is smaller than the expanded configuration but larger than the non-expanded configuration, as shown in Figure 48 . If desired, a medical device, such as a prosthetic heart valve, may be partially or fully withdrawn through the still somewhat expanded (and generally looser or more flexible) tip section 4404. The medical device can also be repositioned by expanding the tip section 4404 to its maximum diameter.

In certain aspects, the distal tip section 4404 of the expandable sheath 4400 may be manufactured according to the methods described below. The distal tip section 4404 disclosed herein may be combined with any of the other aspects of the sheath disclosed herein. In some embodiments, an elongated sheet as shown in Figure 47 of inner liner layer material (as described above) is spirally or helically rolled, resulting in an inner liner layer (as shown in Figures 50-52) . 4408) to form an elongated tube. The first cut 4444 is made to extend proximally from the distal edge 4432 of the inner liner layer 4408. The second cut 4434 is made to extend from the proximal end of the first cut 4444 perpendicular to one of the pair of lateral edges 4436 of the inner liner layer 4408.

As shown in Figure 63 , the flaps 4438 formed by the first and second cuts extend outwardly when the sheet is rolled into the elongated tubular inner liner layer 4408. In one aspect, the flap 4438 is retained in the remaining uncut portion between the second cut 4434 forming the tab and the adjacent lateral edge 4436. Accordingly, the flap is an extension of the sheet that is rolled into the inner liner layer 4408. A radiopaque marker 4428 may be placed between the extended flap 4438 and the underlying layer prior to a subsequent heat treatment step, thereby encapsulating the radiopaque marker 4428. In some embodiments, the radiopaque marker is preformed into a C-shape, but in other embodiments, the radiopaque marker is any other shape suitable for positioning between the flap 4438 and the underlying layer. Additionally, the flap composition itself may include a radiopaque compound. Note that cuts 4444 and 4434 can also be made after rolling the sheet into inner liner layer 4408.

The end of flap 4438 is aligned with the inner longitudinally extending end of rolled inner liner layer 4408 and will ultimately become part of slit 4412. Flap 4438 is wrapped around a rolled elongate tube of inner liner layer 4408 at a slight angle such that the (partially assembled) tip section 4404 tapers toward the distal end 4422 of sheath 4400. all. The distal end 4422 of flap 4438 is trimmed perpendicular to the longitudinal axis. The distal tip section 4404 is wrapped with heat shrink separately from the proximal section 4402 of the expandable sheath 4400. The heat shrink wrap forms and sets the tapered shape, such as by thinning the wall structure of the inner liner layer 4408.

The proximal portion 4402 and tip section 4404 of the rolled elongated inner liner layer 4408 are disposed on the mandrel. Heat is then applied to the distal tip section 4404 during the first reflow step, melting the flap 4438 to the remaining inner liner layer 4408 of the tip section. 50-52 , the area of the first cut 4444 remains visible after melting and reopening to form part of the slit 4412. As shown in FIG. 63 , the tab between the end of the second cut 4434 and the adjacent side edge 4436 is cut to cause the proximal section 4402 of the inner liner layer 4408 to expand and contract helically or helically. It is cut as much as possible.

In one aspect, as described above, prior to the first reflow step, a radiopaque marker 4428 may be positioned between the flap 4438 and the uncut portion of the rolled inner liner layer 4408. 63 and 66 , the flap reflows over the radiopaque marker 4428, encapsulating the radiopaque marker within the inner liner layer 4408. Thinning and tapering of portions of the material may also occur in these steps (and other heating and reflow steps), for example, as shown in Figure 56 .

Next, as shown in FIG. 64 , middle layer 4426 is attached to the distal end of distal tip section 4404 of inner liner layer 4408 such that middle layer 4426 overlaps a portion of inner liner layer 4408. is located. In a second reflow step, middle layer 4426 reflows (melts) with inner liner layer 4408, such that the middle layer extends proximally over the outer surface of the inner liner layer. As shown in FIG. 61 , it may also be possible at this stage for some of the soft middle layer 4426 (and other layers) to be thinned.

As shown in FIG. 65 , outer layer 4410 is then positioned partially over inner liner layer 4408 and a portion of middle layer 4426 such that a portion of middle layer extends distally of outer layer 4410. do. The outer layer is heat treated to couple with the middle layer 4426 by a third reflow/heat treatment step. As such, middle layer 4408 couples outer layer 4410 to inner liner layer 4408. In some embodiments, an intermediate layer may be sandwiched between the inner liner layer 4408 and the outer layer 4410 prior to the second reflow step, thereby forming the inner liner layer 4408, the middle layer 4426, and the outer layer ( 4410) are simultaneously coupled to each other during the second reflow step.

Once outer layer 4410 is bonded to distal tip section 4404, slit 4412 cuts through at least a portion of inner liner layer 4408, outer layer 4410, and middle layer 4426 of the tip section. do. As shown in FIG. 65 , the slit 4412 stops near the distal end of the intermediate layer 4426 to keep the distal end 4422 of the distal tip section 4404 circumferentially continuous.

Advantages of the aforementioned tip section 4404 include ease of manufacture, lower forces to split the tip without stretching, and cleaner splitting, there is no distal or proximal shoulder formed by the layer, and the marker 4428 is sheathed. Embedded in a secure location near the most distal end of 4400, the spit tip has some dynamic recovery after device retry, the middle layer 4426 provides good adhesion of the outer layer (jacket) to the inner liner layer, and the body It is non-traumatic to the lumen. Additionally, the tip section 4404 avoids premature opening during sheath insertion, and the alignment of the slit 4412 with the edge of the inner liner layer 4408 avoids delamination. The outer edge of the scrolled inner liner layer 4408 of the proximal section 4402 is coplanar behind the tip section 4404, eliminating the distal or proximal opposing edge.

method

Aspects of the disclosure also relate to a method of making a sheath having a proximal end and a distal end, the method comprising: rolling a sheet having a first edge and a second edge to form a variable diameter inner liner, the sheet comprising: is defined as an inner surface and an outer surface in a spiral configuration such that at least a portion of the inner surface of the sheet overlaps with at least a portion of the outer surface of the sheet to form an overlapping portion, and the first edge of the sheet is sliding along at least a portion, the second edge being slidable along at least a portion of an outer surface of the sheet, the inner surface of the sheet defining a lumen of the sheath having a longitudinal axis; forming an outer layer having an inner surface and an outer surface and extending around at least a portion of the variable diameter inner liner such that the inner surface of the outer layer is positioned adjacent the outer surface of the inner liner, wherein the outer layer has: a braid or coil; and comprising an elastomeric layer having a predetermined thickness and having an inner surface and an outer surface; wherein the variable diameter inner liner is configured to slide onto a first edge of the sheet along at least a portion of the inner surface and at least a portion of the outer surface during application of a radially outward force by passage of the medical device through the lumen of the inner liner. It is configured to expand from a predetermined resting diameter d _r to an expanded diameter d _e by sliding along the second edge of the sheet.

A variety of methods can be used to make the sheaths described above and below throughout this disclosure. For example, Figures 7 and 8 illustrate block diagrams of exemplary methods of making sheaths in various aspects. Various method steps are also shown in Figures 9A-9K and Figure 31 . In certain embodiments, as shown in Figure 9A , the inner liner may be formed from an extruded tube 903 having an inner surface and an outer surface and any of the thicknesses described above. This extruded tube can be cut 905 along its length to form a sheet. In certain embodiments, the inner surface and/or outer surface of the tube may be surface treated, for example, by plasma etching, chemical etching, or other suitable surface treatment methods. In some example embodiments where the outer surface of the inner liner is treated, the treatment may provide better bonding with the outer layer as it is formed. In another aspect, the inner surface of the inner liner can be deflected. In this exemplary aspect, the ribbed surface may facilitate reduction of points of contact with the prosthetic device and reduce friction. In another aspect, the initial extruded tube 903 can be made by coextrusion with multiple layers of the same or different polymers as described herein. Those skilled in the art will understand that the composition of the inner liner can be selected depending on the desired application. In certain aspects, the decision to use a particular material for the inner liner may depend on desired stiffness, wall thickness, and lubrication optimization. In another aspect, and as discussed above, the tube may also be cut to form longitudinal slits 911 (shown in FIG. 31 ) so that when the formed sheet is wound, as shown in FIG. 32 It forms a spiral scroll configuration as shown.

In another aspect, an elongated single lumen tube used to form an inner liner has an inner surface and an outer surface, wherein at least a portion of the outer surface of the elongated single lumen tube includes a first plurality of protrusions. and/or at least a portion of the interior surface of the elongated single lumen tube includes a second plurality of protrusions. When the helical configuration of the inner member is formed, this tube is cut longitudinally on at least a portion of its circumference to form a sheet having a first longitudinal edge and an opposing second longitudinal edge. In this aspect, the cutting is such that at least a portion of the first plurality of protrusions is disposed abutting a first longitudinal edge of the sheet and/or at least a portion of the second plurality of protrusions is disposed abutting a second longitudinal edge of the sheet. It is carried out. In another exemplary embodiment, when the sheet is rolled into a helical configuration, at least a portion of the inner surface of the sheet overlaps with at least a portion of the outer surface of the sheet to form a portion, wherein the first and/or second plurality of At least a portion of the protrusion of is disposed within the overlap thereby reducing the contact area between the inner surface and the outer surface of the sheet within the overlap. In another aspect, a tube having a first plurality of protrusions disposed on its outer surface and/or a second plurality of protrusions disposed on its inner surface may be manufactured by any method known in the art. . In some embodiments, the tube is formed by coextrusion when the first and/or second plurality of protrusions are coextruded with the remainder of the sheath. In another aspect, the first and/or second plurality of protrusions may be formed by molding using a mold having a desired shape.

It is also understood that embodiments are disclosed herein wherein the second plurality of protrusions are formed on the inner surface of the tube in addition to or instead of the first plurality of protrusions on the outer surface. In this aspect, for example, when a second plurality of protrusions are formed on the interior surface, the tube is cut such that the second plurality of protrusions abut the second longitudinal edge, such that the sheath will be in a scroll configuration. When doing so, the second plurality of protrusions are also disposed in the overlapping portion. It will be further understood that where a second plurality of protrusions are present on the interior surface of the sheet, such second plurality of protrusions may include any one of the disclosed protrusions. Similarly, in aspects where the second plurality of protrusions are disposed on the interior surface, such second plurality of protrusions may be disposed along at least a portion of the length of the inner liner or the entire length of the inner liner. Similar to the aspect in which the first plurality of protrusions are present on the outer surface, when the second plurality of protrusions are present on the inner surface, they may be outside of the overlapping portion when in a scroll configuration or even along the entire circumference of the inner liner. You can.

In another aspect, the elongated single lumen tube used to form the inner liner has an inner surface and an outer surface, wherein at least a portion of the outer surface of the elongated single lumen tube is at least partially within a wall of the elongated single lumen tube. It includes a plurality of junction sites buried in . When the helical configuration of the inner member is formed, this tube is cut longitudinally along at least a portion of its circumference to form a sheet having a first longitudinal edge and an opposing second longitudinal edge. In another exemplary embodiment, when the sheet is rolled into a helical configuration, at least a portion of the inner surface of the sheet overlies at least a portion of the outer surface of the sheet to form an overlapping portion. In this aspect, the outer surface of the sheet within the overlap is substantially free of the plurality of bonding sites, while at least a portion of the outer surface of the sheet outside the overlap includes the plurality of bonding sites.

In another aspect, a tube having multiple joint sites can be manufactured by any method known in the art. In some embodiments, the tube is formed by coextrusion when a plurality of bonded portions are coextruded with the remainder of the sheet. In another aspect, the plurality of bonded portions may be formed by molding using a mold having a desired shape.

In another aspect, a method is also disclosed where one or more bonding sites are located on the interior surface of the outer layer. It will be appreciated that such bonding sites are also known in the art and may be prepared by any method suitable for the desired application. In certain aspects, these exemplary bonding sites may be formed by coextrusion or molding.

In another aspect, more than one mandrel may be provided (step 700 or step 800 of FIGS. 7 and 8 , respectively). The mandrel can be equipped with an external coating, such as a ^Teflon® coating, and the diameter of the mandrel can be predetermined based on the desired resting diameter ( d _r ) of the resulting sheath. As shown in Figure 9B , the sheet formed by cutting ( 905 ) the extruded tube ( 903 ) can be rolled in a helical configuration around the mandrel ( 901 ) to form the inner liner ( 902 ) ( Figures 7 and 8 , respectively). Steps 702 and 802 ), whereby at least a portion of the inner surface of the sheet overlaps at least a portion of the outer surface of the sheet to form an overlap portion 902c , wherein the first edge of the sheet (not shown) ) can slide along at least a portion of the inner surface of the sheet and the second edge 902b can slide along at least a portion of the outer surface of the sheet. If the slit is formed similarly to sult 911 of Figure 31 , the steps for rolling the sheet around the mandrel are similar, but provide a helical configuration rather than a spiral configuration.

In another exemplary embodiment, in steps 705 and 805 ( FIGS. 7 and 8 , respectively), a first lubricant 910 ( FIGS. 9C-9E ) may be selectively applied on the outer surface of the inner liner. The presence of this lubricant material can reduce friction between the inner liner and the outer layer of the final sheath. In another aspect, in steps 703 and 803 , an amount of a second lubricant 908 may be applied between the sliding portion and the overlapping portion of the inner liner to further improve sliding potential and reduce friction. ( FIG. 9D shows the inner liner with two optional lubricants present with the mandrel hidden from view). In another aspect, it is understood that the inner liner formed through the use of a mandrel may have any rest diameter as described above. In certain embodiments, the resting diameter d _r can be substantially uniform along the longitudinal axis of the lumen. Meanwhile, in another embodiment, the resting diameter d _r varies along the longitudinal axis of the lumen, where the resting diameter d _r at the proximal end is greater than the resting diameter d _r" at the distal end. Also, It is understood that what is described herein is an embodiment in which there is no lubricant material between the inner liner and the outer layer.

In another aspect, the method may further include providing a braid or coil (steps 704 and 804 ). It will be appreciated that either the braid or coil described above may be used in this step. In another aspect, and as shown in step 706 of Figure 7 , the braid or coil is mounted on the inner liner. In some example embodiments, and as shown in Figure 9F , the braid or coil 904 may be mounted on a first lubricant 910 , which may be present on the outer surface of the inner liner. It will be appreciated that in some embodiments, the second lubricant may be present on only a portion of the outer surface of the inner liner. In another aspect, the disclosed sheath can have an area where a first lubricant is present and a braid or coil is mounted thereon, while having another area where a second lubricant is not present, wherein the braid or coil is It is mounted directly on the outer surface of the inner liner. It will be appreciated that the location of these specific segments may be determined by those skilled in the art depending on the desired application. It will be appreciated that mounting the braid or coil may be performed by methods known in the art. In some non-limiting aspects, the braid or coil may be provided as a cylindrical tube, upon which an inner liner or first lubricant may be slid if present.

In another aspect and as shown in step 708 , the method may further include providing a layer of elastomeric polymer. In this exemplary embodiment, this layer of elastomeric polymer may be used as the outer layer of the sheath. It will be appreciated that any of the disclosed elastomers described above may be used. Particular polymers may be selected based on desired properties of the disclosed sheath, such as, for example, level of stiffness, hemostasis, etc. The layer of elastomeric polymer may be provided in any form known in the art. In certain and non-limiting aspects, the elastomeric polymer may be provided as a cylindrical tube 906 ( FIG. 9G ). In another aspect, the elastomeric polymer may be mounted on the inner liner and braid or coil (step 710 ). 9G shows, for example, an embodiment in which a cylindrical tube of elastomeric polymer 906 is used to slide on an inner liner with a first lubricant 910 overlying the outer surface of the inner liner and the braid or coil 904 . shows.

In another aspect, the disclosed method may include embedding the braid or coil into a layer of elastomeric polymer that acts as an outer layer (step 711 , Figure 7 ). It is understood that a cis may contain a variety of segments. In some embodiments, some segments may include a braid or coil embedded within a layer of elastomeric polymer, while in other segments the braid or coil and the layer of elastomeric polymer are separate. In some embodiments, the sheath can have a braid or coil embedded in the elastomeric polymer over the entire length of the sheath, while in other embodiments the braid or coil is not embedded in the elastomeric polymer over the entire length of the sheath. It is further understood that It will be further understood that any method known in the art may be used to embed the braid or coil within the elastomeric polymer. In some aspects, application of heat may be used. In certain embodiments, the use of heat shrink tubing may be utilized to embed the braid or coil within the elastomeric polymer. It is understood that after the embedding step is completed, the heat shrink tubing is removed. In another aspect, the braid or coil can be embedded within a layer of elastomeric polymer by placing the assembly in an oven or otherwise heating it.

In another aspect, the method further includes thermally bonding the elastomeric polymer used as the outer layer to the inner liner through at least a portion of the plurality of bonding sites.

In another aspect, a soft atraumatic tip may be provided at the distal end of the created sheath (step 712 ). In another aspect, the outer layer comprising braids or coils and the layer of elastomeric polymer are at least partially bonded to the inner liner. It is understood that such bonding may also be accomplished by any method known in the art. In certain embodiments, and as shown in step 714 , heat shrink is applied to the joined and heated portions to form a bond between the inner liner and the outer layer. In another aspect, bonding between the inner liner and the outer layer may be accomplished by placing the assembly in an oven or otherwise heating it. In another aspect, the bonding step is performed by heating at a temperature of about 350 ^o F to about 550 ^o F for a time effective to form a bond between at least a portion of the outer layer and at least a portion of the inner liner. In another aspect, the heating step may be performed at a temperature of about 375 ^o F, about 400 ^o F, about 425 ^o F, about 450 ^o F, about 475 ^o F, about 500 ^o F, or about 525 ^o F. . In another embodiment, the effective time to form a junction is about 5 seconds, about 10 seconds, about 15 seconds, about 20 seconds, about 25 seconds, about 30 seconds, about 35 seconds, about 40 seconds, about 45 seconds, It can range from about 1 second to about 60 seconds, including exemplary values of about 50 seconds, and about 55 seconds. However, it will be further understood that such time is not limiting and may have any value necessary to provide effective bonding, for example within the range of about 1 second to about 5 hours. It is further understood that if heat shrink tubing is used to achieve the desired joint, the heat shrink tubing is removed (step 716 , Figure 7 ).

In a still further aspect, and as shown in Figure 9I , the bonding step also includes bonding at least a portion of the inner surface of the elastomeric polymer layer to at least a portion of the outer surface of the sheet of the inner liner ( 902c ) a first strip 920 of elastomeric polymer applied along at least a portion of the longitudinal axis of the lumen to at least a portion of the outer surface of the sheet not previously or during an overlapping portion. In some example embodiments, and as shown in Figure 9I , this first strip may be applied prior to mounting the braid or coil. In another aspect, the location where the first strip is applied does not include the first lubricant. However, it is understood that in this aspect, the first lubricant may be present in other locations.

In another exemplary embodiment, the method may include a second strip 922a of elastomeric polymer, which covers at least a portion of the interior surface of the elastomeric polymer layer to at least a portion of the exterior surface of the sheet of the inner liner. It may be applied to at least a portion of the outer surface of the sheet at the proximal end of the sheath before or during the bonding step. In some example embodiments, and as shown in Figure 9J , this second strip may be applied prior to mounting the braid or coil. In another aspect, the location where the second strip is applied does not include the first lubricant. However, it is understood that in this aspect, the first lubricant may be present in other locations. In another aspect, the method may include a third strip 922b of elastomeric polymer, bonding at least a portion of the interior surface of the elastomeric polymer layer to at least a portion of the exterior surface of the sheet of the inner liner. Before or during the step, a third strip of elastomeric polymer may be applied to at least a portion of the outer surface of the sheet at the distal end of the sheath. In some example embodiments, and as shown in Figure 9J , this second strip may be applied prior to mounting the braid or coil. In another aspect, the location where the third strip is applied does not include the first lubricant. However, it is understood that in this aspect, the first lubricant may be present in other locations. In another embodiment, both second and third elastomeric polymers are present. Meanwhile, in other embodiments, only either the second or third elastomer is present. Additionally, it will be appreciated that the first, second and third elastomeric polymers may be the same or different. It will also be appreciated that the first, second and third elastomeric polymers may be the same as the layers of elastomeric polymer present in the outer layer and may include any of the elastomeric polymers described herein.

Figure 9K shows a cross-sectional view of the sheath at step 718 of Figure 7 . Sheath 900 made according to the described methods and processes may be attached or joined to housing 101 , such as by bonding the proximal end of sheath 900 to polycarbonate housing 101 .

Some alternative embodiments are shown in FIGS . 8 and 9H . In this alternative embodiment, the outer layer is preformed and then mounted on an inner liner positioned on a mandrel. In this embodiment, the provided layer of elastomeric polymer is first mounted on the braid or coil prior to mounting on the inner liner (step 808 ). In another aspect, the method may also include partially embedding the braid or coil within a layer of elastomeric polymer prior to mounting both on an inner liner (step 809 ). However, the step of partially embedding the braid or coil with the layer of elastomeric polymer may be performed after the braid or coil, where the layer of elastomeric polymer is mounted on the inner liner (step 811 ). Steps 812-818 may be performed similarly to steps 712-718 .

In another aspect, and as shown in FIG. 9I , the bonding step also includes bonding at least a portion of the inner surface of the elastomeric polymer layer to at least a portion of the outer surface of the sheet of the inner liner ( 902c ). or a first strip 920 of an elastomeric polymer applied along at least a portion of the longitudinal axis of the lumen to at least a portion of the outer surface of the sheet, not including the overlapping portion. In some example embodiments, and as shown in Figure 9I , this first strip may be applied prior to mounting the preformed outer layer comprising the braid or coil and the elastomeric polymer. In another aspect, the location where the first strip is applied does not include the first lubricant. However, it is understood that in this aspect, the first lubricant may be present in other locations.

This alternative embodiment also provides that, prior to or during the step of bonding at least a portion of the inner surface of the elastomeric polymer layer to at least a portion of the outer surface of the sheet of the inner liner, the second strip 922a of elastomeric polymer is It is understood to include steps that can be applied to at least a portion of the outer surface of the sheet at the distal end of the sheath. In some example embodiments, and as shown in Figure 9J , this second strip may be applied prior to mounting the preformed outer layer comprising the braid or coil and the elastomeric polymer. In another aspect, the location where the second strip is applied does not include the first lubricant. However, it is understood that in this aspect, the first lubricant may be present in other locations. In another aspect, the method may also include a third strip 922b of elastomeric polymer, which includes at least a portion of the interior surface of the elastomeric polymer layer and at least a portion of the exterior surface of the sheet of the inner liner. Prior to or during the bonding step, a third strip of elastomeric polymer may be applied to at least a portion of the outer surface of the sheet at the distal end of the sheath. In some example embodiments, and as shown in Figure 9J , this third strip may be applied prior to mounting the preformed outer layer comprising the braid or coil and the elastomeric polymer. In another aspect, the location where the third strip is applied does not include the first lubricant. However, it is understood that in this aspect, the first lubricant may be present in other locations. In another embodiment, both second and third elastomeric polymers are present.

It will be appreciated that in embodiments where a plurality of bonding sites are present, bonding between the inner liner and the outer layer (or elastomeric polymer) may be effected via the plurality of bonding sites.

Also disclosed herein are methods of making additional configurations of the sheath. For example, disclosed herein is a method of making a sheath having proximal and distal ends. This method includes forming a variable diameter inner liner by providing an elongated single lumen tube comprising at least one polymer layer; longitudinally cutting at least a portion of the circumference of the elongated single lumen tube to form a sheet having a first longitudinal edge and an opposing second longitudinal edge and having an inner surface and an outer surface; and subsequently forming a variable diameter inner liner by rolling the sheet in a spiral configuration such that at least a portion of the inner surface of the sheet overlies at least a portion of the outer surface of the sheet, thereby forming an overlapping portion. and wherein a first edge of the sheet is slidable along at least a portion of an interior surface of the sheet and a second edge is slidable along at least a portion of an exterior surface of the sheet, wherein the interior surface of the sheet is: Defines the lumen of the sheath with its longitudinal axis.

It is understood that the elongated single lumen tubes may be extruded or co-extruded from any of the polymers or compounds described above. For example, and without limitation, the elongated single lumen tube may include at least one polymer including polyolefin, polyamide, fluoropolymer, copolymers thereof, coextrudates thereof, or blends thereof. However, in other embodiments, the compound material may include polyolefin and lubricating filler. In this exemplary embodiment, the polyolefin may be high density polyethylene. However, in another aspect, the lubricating filler may include polytetrafluoroethylene (PTFE) filler. In this embodiment, the lubricating filler may be present in an amount from about 5% to about 20% by weight of the total weight of the compound material.

For example, and without limitation, the tubular body can be extruded to form an elongated tube containing the compound material. These compound materials include a polyolefin present in an amount of greater than 0% to less than 100% by weight based on the total weight of the compound, and a lubricating filler present in an amount of from about 5% to about 20% by weight of the total weight of the compound material. may include.

Extruded or coextruded elongated single lumen tubes can have a coefficient of friction of less than about 0.5.

In another aspect, a single lumen tube can be made by coextrusion with multiple layers of the same or different polymers as described herein. In another aspect and as described above, such tubes may be coextruded with any of the tie layers described above. In this exemplary embodiment, the elongated tube may comprise any of the polymers described above, for example, if a tie layer is present, and the tie layer is disposed on the inner surface of the tube and/or the outer surface of the tube. .

It will be appreciated that such an elongated tube is used to form an inner liner, in which any of the materials described above may be used. Before cutting the tube to form the helical configuration of the inner liner, a lubricating liner may be placed on the inner surface of the tube and/or the outer surface of the tube. It is understood that such lubricating liners, if present, may be disposed on the tie layer. In certain embodiments, a tie layer is used to join a lubricating liner with a polymer layer forming an elongated tube. In another aspect, at least a portion of the interior surface of the elongated tube may be ribbed. In this exemplary aspect, the ribbed surface may facilitate reduction of points of contact with the prosthetic device and reduce friction.

However, in other embodiments where a tie layer and/or lubricating liner are present, at least a portion of the lubricating liner may also be ribbed. Additionally, in this embodiment, the tube comprising any of the polymer, tie layer, and lubricating liner described above has a coefficient of friction of less than about 0.5.

The elongated tube is then placed on the mandrel and at least a portion of the tube's circumference is cut as described above. In another aspect, the method of forming the inner liner is similar to the method shown in Figure 9A . The inner liner has an inner surface and an outer surface and may be formed from a single lumen extruded tube 903 having any of the thicknesses described above. This extruded tube can be cut 905 along its length to form a sheet.

Additionally, in certain embodiments, the interior surface and/or exterior surface of any of the single lumen tubes described above may be further surface treated, such as by plasma etching, chemical etching, or other suitable surface treatment methods. In some example embodiments where the outer surface of the inner liner is treated, the treatment may provide better bonding with the outer layer as it is formed. Those skilled in the art will understand that the composition of the inner liner can be selected depending on the desired application. In certain aspects, the decision to use a particular material for the inner liner may depend on desired stiffness, wall thickness, and lubrication optimization.

The formed sheet can then be placed on a further mandrel. These mandrels can be equipped with an external coating, such as a Teflon ^® coating, and the diameter of the mandrel can be predetermined based on the desired resting diameter ( d _r ) of the resulting sheath. As shown in FIG. 9B , the sheet formed by cutting 905 the extruded tube 903 can be rolled in a helical configuration around the mandrel 901 to form the inner liner 902 , thereby forming the inner liner 902 of the sheet. At least a portion of the surface overlaps at least a portion of the outer surface of the sheet to form an overlap portion 902c , where a first edge of the sheet (not shown) slides along at least a portion of the inner surface of the sheet. and the second edge 902b can slide along at least a portion of the outer surface of the sheet. It will be appreciated that any of the above-described helical configurations may be obtained.

For example, the sheet is rolled such that the first and second edges of the sheath are substantially aligned in spaced apart relationship along a vertical axis passing through the thickness of the sheath. In this aspect, the spaced relationship may include a portion of the sheet positioned between the first edge and the second edge along the vertical axis. In certain embodiments, the sheet is rolled such that when the sheath is at rest in an unexpanded state, the inner liner comprises at least two layers of the sheet overlapping each other along at least a portion of the sheath circumference. In yet another embodiment, when the sheath is in its non-expanded resting state, at least a portion of the sheath circumference comprises each of three layers of sheets overlapping one another. Also disclosed are aspects in which, when the sheath is rolled in a helical configuration, a first edge of the sheet may be substantially aligned with a vertical axis passing through the thickness of the sheath and a second edge may be circumferentially offset from the vertical axis. . In this configuration, in some embodiments, along at least a portion of the circumference of the sheath, the inner liner will comprise one layer of sheet without any overlapping portions.

However, in certain embodiments, the inner liner may be formed from an extruded double lumen tube. The extruded double lumen tube may include any of the polymers or compounds described above. Exemplary schematics of a method of manufacturing an inner liner from such a double lumen tube are shown in FIGS. 20A-20C . The dual lumen 2000 may include a first channel 2002 having an inner surface 2002a and an outer surface 2002b and a second channel 2004 having an inner surface 2004a and an outer surface 2004b . . The second channel 2004 is located within the first channel 2002 such that at least a portion of the circumference of the first channel and at least a portion of the circumference of the second channel have at least one shared inner surface and at least one have a shared external surface ( 2006 ). In this configuration, the outer surface 2002b of the first channel 2002 defines the outer surface of the double lumen tube.

It will be appreciated that such a dual lumen tube may include any one of the disclosed layers.

For example, dual lumen tubes can be coextruded from the compound materials described above. In this exemplary embodiment, the first channel may comprise a compound material, or the second channel may comprise a compound material as described above.

In another aspect, the dual lumen tube may be coextruded with any of the tie layers described above, where the tie layer may be coextruded with the first channel or the second channel, or both. In another aspect, any one of the lubricating liners described above may be disposed in a tie layer. This may be placed, for example, in the first channel, the second channel, or both.

In another aspect, as shown in FIG. 20B , the first channel may be cut longitudinally along at least a portion of the first channel circumference 2008 that is not shared with the circumference of the second channel to form a first sheet. You can. The first sheet 2010 has a first edge 2012 and a second edge 2014 , and the second channel is disposed longitudinally along at least a portion of the first sheet 2004 , so that the second channel At least a portion of the circumference of has at least a portion having a surface 2016 shared with the first sheet along the length of the sheet and along the length of the second channel.

The second channel is then cut longitudinally at a portion of the circumference of the second channel 2018 that abuts the shared surface 2016 with the first sheet to create a first edge 2022 and a second edge 2024 . forming a second sheet 2020 , where the second edge is defined by a portion of a shared surface with the first sheet 2016 .

In another aspect, the first and second sheets are rolled into a helical configuration, as shown in FIG. 20C , such that: the shared surface 2016 between the second sheet and the first sheet is formed between the first surface and the second opposing sheet. to form a first portion ( 1802 ) ( 2016 ) of the inner liner having a surface. At least a portion of second sheet 1806 forms a first segment of the inner liner having a first surface and an opposing second surface. A portion 1810 of the first sheet adjacent the second end of the second sheet and extending to the first end of the first sheet includes a second segment 1810 of the inner liner having a first surface and an opposing second surface. form A portion of the first sheet adjacent the second end 1808 of the second sheet and extending to the second end of the first sheet includes a third segment 1808 of the inner liner having a first surface and an opposing second surface. forms. In this helical configuration, and as shown in FIGS. 20C and 18 , at least a portion of the first surface of the second segment overlaps with at least a portion of the second surface of the first segment, wherein the at least a portion of the first surface overlaps with at least a portion of the second surface of the second segment, and at least a portion of the first surface of the third segment overlaps with at least a portion of the second surface of the first segment; wherein the first surface of the first portion extends into the first surfaces of the first segment, the second segment and the third segment, and the second surface of the first portion extends into the second surfaces of the second and third segments. .

In certain aspects, the method may include discarding an amount of lubricant prior to the cutting step, regardless of whether the inner liner is formed from a single lumen tube or a double lumen tube. It is understood that the lubricant may be disposed on any surface of any channel.

In another aspect, the lubricant can be placed manually. Meanwhile, in another aspect, the lubricant may be disposed by pad printing. Additionally, in another aspect, the lubricant can be deployed by spraying.

It will be appreciated that any of the lubricants described above may be used.

If the lubricant is placed manually, any technique known in the art may be used. For example, without limitation, the lubricant can be disposed of with a brush, cloth, pad, etc.

In some embodiments, the lubricant is disposed by pad printing. During pad printing, a quantity of lubricant is placed into concave channels on the plate. The length and width of the channel can be predetermined as desired. For example, the length and width of the channel can correspond to the desired area on the surface of the inner liner where the lubricant is disposed. The volume of the channel can also be defined, which partly determines the total amount of lubricant to be transported. In this aspect, a soft pad can be dipped into the channel to pick up lubricant and moved over a desired portion of the inner liner. The pad can then be stamped onto a predetermined portion of the liner to deliver the lubricant onto the surface of the inner liner.

In aspects disclosed herein, it is understood that a predetermined amount of lubricant is applied to set locations (predetermined portions) of the inner liner surface. In this aspect, the methods disclosed herein allow for substantial control of both the application area and volume of the lubricant used. As discussed above, because the depth of the channel can be controlled, the amount of lubricant disposed on the surface of the inner liner can also be substantially controlled.

In embodiments where pad printing is used to transfer a lubricant onto the surface of the inner liner, any of the lubricants described above may be used. In certain embodiments, the lubricant used in the pad printing method is substantially viscous. In certain exemplary, non-limiting embodiments, the lubricant may have a viscosity of about 600 cP to about 1,200 cP. It will be appreciated that in another aspect, the viscosity of a lubricant can be adjusted by adding more solids or more solvent to the lubricant composition. For example, and without limitation, a lubricant such as MED10-6670 (or similar) may have a viscosity exceeding its standard viscosity.

It is understood that the use of pad printing allows the lubricant to be applied to very specific parts of the inner liner with tight tolerances. In certain aspects, the lubricant may include a fluorescent material or any other material that allows determination of a specific location on the device. In this aspect, for example, specific lubricant locations can be determined under UV light. This allows for easy quality control to determine whether the lubricant has been applied to the desired portion of the sheath.

However, in other aspects, substantially accurate pad printing can help reduce pressing forces by reducing friction in the most relevant areas of the sheath while simultaneously preventing unwanted migration of lubricant.

In certain embodiments, the lubricant may be applied around a portion of the circumference of the inner liner. However, in other embodiments, the lubricant may be applied around the entire circumference of the outer surface of the inner liner.

In another aspect, the lubricant may be delivered in a predetermined pattern. For example, this could be passed in a "strip" pattern. However, it is understood that these patterns are illustrative only. The pattern may have any regular or irregular shape. For example, if the pattern is a stripe pattern, the lubricant may be disposed in a plurality of stripes along the entire length of the inner liner or along a portion of the inner liner. In another aspect, the pattern can have a triangular shape, a tapered shape, an oval shape, a circular shape, a rectangular shape, or any irregular shape. The pattern can be determined based on the desired application and/or desired location on the outer surface of the inner liner.

In another aspect, the inner liner can be rotated by the pad printing machine between runs to allow the printer to create lines of lubricant (or any other desired shape) at new locations along the surface of the inner liner. In addition to accurately controlling the amount of lubricant added to the inner liner and lubricant locations, these methods reduce the amount of lubricant and increase the number of sheaths that can be discarded due to inaccurate application of lubricant, which can affect overall sheath performance. By reducing , it makes the manufacture of sheaths more cost-effective.

In another aspect, the lubricant may be applied by spray coating. In this method, lubricant is loaded into a spray bottle. The sheath, or more specifically the inner liner, is mounted on a mandrel that can rotate about the long axis of the sheath. The lubricant is then sprayed onto the rotating sheath and converted to the desired portion of the inner liner length, ensuring substantially uniform coverage. The amount of lubricant to be sprayed on the inner liner, the speed at which the nozzle moves along the sheath, and the sheath rotation speed can all be specified to optimize this application process.

In certain embodiments, any of the lubricants described above may be used. In embodiments where spray coating is used, the viscosity of the lubricant is less than or equal to 600 cP. Spray coating uses equipment to spray a liquid solution input into a spray coating machine. The resulting spray can be used to coat a variety of devices. For expandable sheath devices, the lubricant is mixed and fully prepared and then loaded into the machine.

In order to apply the lubricant on the inner liner in a substantially uniform manner, the inner liner is mounted on a mandrel configured to rotate along the long axis of the sheath at a certain speed. The nozzle of the coating machine then sprays atomized droplets of lubricating solution onto the inner liner. The nozzle translates, rotates and moves horizontally along the length of the sheath. The speed can be adjusted to optimize the amount of lubricant sprayed on the inner liner. It is understood that if more lubricant is required, the speed may be slower, so that the nozzle remains in a given position along the surface of the inner liner for a longer period of time, and vice versa. As in pad printing, the lubricant may consist of a fluorescent component so that, under black light, the areas of the sheath coated with the lubricant are clearly visible.

In another aspect, after applying the lubricant on the surface of the inner liner, the lubricant is cured. It is understood that curing may be carried out under any conditions effective to provide the desired results. In certain exemplary, non-limiting embodiments, curing is performed in an oven. Curing temperature and time may be defined by the specific lubricant used in the method described above.

In yet a further aspect, the method comprises disposing the outer layer over at least a portion of the outer layer of the inner liner, thereby forming a predetermined resting diameter ( d) by sliding the first longitudinal edge of the sheet along at least a portion of the inner surface. forming a sheath configured to extend from _r to an expanded diameter d _e, while applying a radial outward force by passage of a medical device through the lumen of the inner liner, the sheet along at least a portion of the outer surface. It may further include the step of sliding the second longitudinal edge of .

In certain embodiments, the outer layer may be prepared by extruding a tubular body to form an elongated tube comprising a first polymer layer, wherein the first polymer layer is greater than 0% to 100% by weight. polymers comprising less than or equal to polyether block amides, polyurethanes, or combinations thereof; less than about 65% by weight of inorganic filler based on the total weight of the first compound composition; and up to about 20% by weight of a solid lubricating filler, based on the total weight of the first compound composition. These elongated tubes can then be placed on any of the inner liners disclosed above to form the outer layer of the sheath. It will be appreciated that any of the additional layers described above may also be present between the inner liner and the outer layer.

In another aspect, an outer layer as presented herein can be made by coextruding an elongated bump tube comprising a first polymer layer and a second polymer layer; wherein the first polymer layer comprises: a first compound composition comprising greater than 0% to less than 100% by total weight of the first compound composition of a polymer comprising polyether block amide, polyurethane, or a combination thereof; Less than about 65% of inorganic filler based on the total weight of the first compound composition; and up to about 20% solid lubricating filler by total weight of the first compound composition; The second polymer layer comprises polyurethane, wherein the first polymer layer defines the interior surface of the tube and the second polymer layer defines the exterior surface of the tube; This tube is then placed on the surface of one of the inner liners disclosed herein. It will be appreciated that any of the additional layers described above may also be present between the inner liner and the outer layer.

In another aspect, the method also includes the steps of a) forming an inner liner by any of the disclosed methods described above, followed by b) disposing a first polymer layer comprising a first compound composition, This includes, by total weight of the first compound composition, greater than 0% and less than 100% of a polymer comprising polyether block amide, polyurethane, or a combination thereof; Less than about 65% of inorganic filler based on the total weight of the first compound composition; and up to about 20% solid lubricating filler by total weight of the first compound composition; wherein the first polymer layer is disposed over the proximal portion of the inner liner and has a length of about 5 cm to about 15 cm; c) disposing a second polymer layer comprising polyurethane over the first polymer layer, wherein the second polymer layer extends along the length of the sheath; and wherein the first polymer layer and the second polymer layer together form the outer layer of the sheath.

It will be appreciated that any method known in the art may be used to form any of the compositions disclosed herein. In certain embodiments, ingredients present in any of the elongated tubes disclosed herein are provided to form a compound. The compounds are then mixed to form a substantially homogeneous mixture. However, in other embodiments, the mixture is homogeneous. In another aspect, the mixture is extruded to form an elongated tube with the first polymer layer. The first polymer layer formed may include any of the compositions and properties described above (and in any combination).

In another aspect, the method also includes forming an elongated tube comprising two or more layers, as described above. In this embodiment, for example, when the elongated tube comprises either the first polymer layer or the second polymer layer described above, these layers can be coextruded to form the elongate tube as disclosed. Any of the extrusion devices known in the art can be used to obtain any of the desired elongated tubes.

Also disclosed herein are methods for bonding the outer layer and inner liner, if desired. It will be appreciated that any method known in the art may be used to form the joint. In certain aspects, heat treatment may be used. For example, the sheath can be inserted into a heat shrink tube and heated together to a temperature that allows at least partial bonding between the inner liner and the outer layer.

Some additional example embodiments may include laser welding, compression head welding, or ultrasonic welding, as shown in Figures 28A-C .

In another aspect, laser welding may be used. In this aspect, the inner liner may be formed by any of the methods described above. An outer layer comprising any one of the disclosed compositions and formed by any of the methods described above is then disposed over the inner liner to form a sheath. Additionally, it will be appreciated that any one of the disclosed layers may also be present between the inner liner and the outer surface. The sheath is then positioned on a mandrel configured to rotate. Laser welding uses a focused laser to heat a part at a selected location. The mandrel is aligned with a laser beam configured to travel along the longitudinal axis of the sheath at a predetermined distance under conditions effective to form a joint ( FIG. 28A ). In this aspect, the head of the laser jointer is positioned directly over the center of the sheath, and the sheath can be rotated to align the laser with any desired point on the diameter of the sheath. The laser joint then moves horizontally across the sheath.

The joint may be formed in a predetermined portion of the sheath between at least a portion of the outermost surface of the inner liner and at least a portion of the innermost surface of the outer layer. However, it is understood that the predetermined locations where the joint is formed are substantially free of lubricant and/or tie layers, although other additional layers, such as lubricant or tie layers, may be present.

It will be appreciated that settings for a laser welder can be changed to optimize both the heating and bonding areas on the device. In terms of power, the laser power converts the heat imparted onto the sheath, while the feed rate adjusts the length of time the laser is focused on a given portion of the sheath. The focus position, weld start angle, and weld distance can be used to control the area of the laser and fine-tuned to create an accurately sized joint.

Settings for a laser welder can be varied in terms of power, while feed rate is understood to adjust the length of time the laser is focused on a given part of the sheath. The focus position, weld start angle, and weld distance can be used to control the area of the laser and fine-tuned to create an accurately sized joint. Additionally, additional methods of forming joints are disclosed herein. For example, a compression head jointer can be used ( Figure 28b ). In this method, the inner and outer layers are formed and assembled by any of the methods disclosed above to form a sheath. The sheath is then placed on the mandrel into a radial compression head jointer.

Any compression head jointer known in the art may be used. In certain aspects, the compression head joint may include an extrusion aperture configured to compress the sheath to a predetermined diameter. The radial compression head joint includes a plurality of dies, where at least one of the plurality of dies can be heated to form a joint at a pre-end portion of the sheath.

An exemplary, non-limiting jointer may include a total of 9 separate dies, 8 made of PEEK plastic, for example, and 1 metal die, as shown in FIG. 28B . The metal die may be heated prior to use. The machine sets the jaws of the aperture together to a smaller diameter and then compresses them around the device inserted through the block. The heated die then melts the portion of the inserted component that comes into contact with it. For use with expandable sheaths, a mandrel is inserted into the lumen of the device to prevent compression of the sheath shaft while under the load of the adapter. In certain embodiments, fluorinated ethylene propylene can be placed over the desired bonding area of the sheath to transfer heat evenly, preventing the metal from directly combusting the outer layer. The sheath can be supported on the machine using separate channels for the sides. In certain embodiments, the width of the bonding die may be less than the length of the sheath, thus extending the bonding area, and the sheath can be moved horizontally after each run and the bonding can be repeated for a desired length along the sheath. there is.

It will be appreciated that the specific junction and its location can be controlled as desired. For example, the temperature of the metal die can be determined to ensure that it is set at a temperature effective to at least partially melt both the outer layer and the inner liner components. In another aspect, the compressive force applied on the part can also be adjusted to achieve at least partial melting without any substantial damage to the remaining components of the sheath. The aperture reaches its final diameter while the joint is also predetermined. It is understood that the larger the diameter and the more the metal die is exposed to the component, the larger the bonding area can be. Additionally, the length of time the die is compressed against the sheath can also affect the degree of melting of the components and the strength of the joint.

In another aspect, the method may include ultrasonic welding. In this aspect, the sheath component to be joined is placed on a welder and a load is then applied from a mobile horn. The horn moves at very high speeds, imparting high amounts of vibrational energy. This energy is absorbed by the material, which may melt at a predetermined location. Molten materials can flow together and thus form a bond when cooled. In some aspects, ultrasonic welding may be used prior to forming the fully assembled sheath. For example, in this aspect, ultrasonic welding may be used to join any desired part at any stage during manufacturing.

Additionally, a method of manufacturing a sheath comprising a reinforcing jacket is disclosed. In this method, the sheath components, such as the inner liner and outer layer, are formed by any of the above disclosed methods and assembled together to form the sheath. A reinforcing jacket having a proximal end and a distal end is then placed overlying at least a portion of the outer layer. The method further includes substantially seamlessly joining the distal end of the reinforcement jacket to at least a portion of the outer layer. It will be appreciated that the disclosed methods or any conjugation method generally known in the art may be used.

The reinforcing jacket may include any of the components described above, and the reinforcing jacket may include any of the elastomers described above and any of the reinforcing elements described above.

In another aspect, the reinforcement jacket may be formed by any method known in the art. For example, the reinforcement jacket can be formed by injection molding, extrusion, or reflow processes. In another aspect, any of the reinforcing members disclosed herein can be embedded in a soft polymer to form a reinforcing jacket. For example, and without limitation, during the reflow process, reinforcing elements can be placed on top of the polymer layer and exposed to heat to cause the reinforcing elements and polymer to fuse together. In another exemplary aspect, the reinforcement jacket may be formed by injection molding. In this embodiment, the reinforcing elements can be placed within a mold and the polymer is injected thereon. However, in another exemplary, non-limiting aspect, the reinforcement jacket may be formed by an extrusion process. In this exemplary embodiment, the heated polymer may be extruded into a tube during parallel feeding of the reinforcing elements to allow the polymer and reinforcing elements to combine.

Additionally, a method of manufacturing a sheath comprising a balloon guard is provided. In this method, the sheath components, such as the inner liner and outer layer, are formed by any of the above disclosed methods and assembled together to form the sheath. A balloon guard having a proximal end and a distal end is then positioned to overlie at least a portion of the outer layer, wherein the balloon guard is configured to remain external to the subject's blood vessel and maintain hemostasis. The method further includes connecting the proximal end of the balloon guard to the proximal portion of the outer layer and/or the hub of the sheath, wherein the distal end of the balloon guard radially surrounds at least a portion of the outer layer. , the distal end is not joined to the outer layer. The balloon guard is configured to adjust the length of the guard as a function of the depth of insertion of the inner liner and outer layer of the sheath into a blood vessel of a subject, as described herein.

In another aspect, the methods disclosed herein can include disposing a hydrophilic coating layer on the outer surface of the elastomeric polymer layer. Any of the hydrophilic coatings disclosed herein may be used.

The sheath of the present disclosure can be used with a variety of methods for introducing an artificial device into a patient's vascular system. One such method includes placing an expandable sheath within a blood vessel of a patient, passing the device through an introducer tube that allows a portion of the sheath surrounding the device to expand and accommodate the profile of the device, and and automatically retracting the expanded portion of the sheath to its original size after passing through the portion. In some methods, the expandable sheath can be sutured to the patient's skin at the insertion site such that once the sheath is inserted at an appropriate distance within the patient's vasculature, it does not move once the implantable device begins to move through the sheath.

The disclosed embodiments of the expandable sheath can be used with other delivery elements such as introducers and loaders and minimally invasive surgical components. The introducer sheath can be inserted within the expandable sheath, and the introducer sheath/sheath combination can be fully inserted into the vasculature through a guiding device, such as a 0.35'' guidewire. Once the sheath and introducer sheath are fully inserted into the patient's vasculature, in some embodiments, the expandable sheath can be sutured in place at the insertion site. In this way, the expandable sheath can be substantially prevented from moving once placed within the patient.

The introducer sheath can then be removed, and a medical device, such as a transcatheter heart valve, can be inserted into the sheath, in some cases using a loader. The method may further include placing a tissue heart valve in a crimped condition on the distal end portion of the elongated delivery device and inserting the elongated delivery device with the crimped valve into and through the expandable sheath. there is. Next, the delivery device can be advanced through the patient's vascular system to the treatment site where the valve can be implanted.

Typically, the medical device has an outer diameter that is greater than the diameter of the sheath in its original configuration. The medical device can be advanced through the expandable sheath toward the implantation site, and the expandable sheath can be locally expanded to receive the medical device as it passes through. The radial force applied by the medical device may be sufficient to locally expand the sheath to an expanded diameter (e.g., expanded configuration) in the area where the medical device is currently located. Once the medical device has passed a particular location in the sheath, the sheath may at least partially retract to the smaller diameter of its original configuration. Accordingly, the expandable sheath can be expanded without using an inflatable balloon or other expander. Once the medical device is implanted, the sheath and any sutures holding it in place can be removed. In some exemplary embodiments, the sheath is removed without being rotated.

Example

The following examples are presented to those skilled in the art to provide a complete disclosure and explanation of how the compounds, compositions, articles, devices and/or methods claimed herein may be made and evaluated, and are intended to be purely illustrative and present. It is not intended to limit disclosure. Efforts have been made to ensure accuracy of numbers (e.g. amounts, temperatures, etc.), but some errors and deviations must be accounted for.

Unless otherwise specified, parts are by weight, temperatures are in degrees Celsius (C) or at ambient temperature, and pressures are at or near atmospheric or full vacuum.

Figure 16 shows exemplary experimental data measured for the insertion force required to insert a medical device into one of the sheaths ( 3 ) disclosed herein compared to commercially available sheaths ( 1 and 2 ). Force was measured using a conventional transmission system on a Zwick pressure test machine. It can be seen that the required insertion force measured at the tapered section of the sheath is lower than that required for commercially available sheaths ( 1 and 2 ). Similarly, the insertion force measured at the contracted body peak shows better results for the disclosed sheath ( 3 ) compared to the commercially available sheaths ( 1 and 2 ).

Figure 17 shows experimental data of measured load as a function of extension of the sheath 3 disclosed herein and one of the commercially available sheaths 1 and 2 . It can be seen that the disclosed sheath shows similar results to clinically acceptable commercial sheaths.

In light of the methods and components described, certain more specifically described aspects of the disclosure are described below. However, these specifically recited aspects may have any limiting effect on any different claims containing different or more general teachings set forth herein, or the "specific" aspects may be referred to in the language used literally therein and It should not be construed as limiting in any way other than the inherent meaning of the chemical formula.

Exemplary Embodiments:

Example 1: A sheath for delivering a medical device, the sheath having a proximal end and a distal end: a tubular inner liner, a length extending along the length of the tubular inner liner such that the tubular liner is wound in a helical scroll configuration. comprising a tubular inner liner having directional slits; wherein the longitudinal slits define a first longitudinal edge and a second longitudinal edge of the tubular inner liner; In the helical scroll configuration, at least a portion of an inner surface of the inner liner helically overlaps at least a portion of an outer surface of the inner liner, and a first longitudinal edge of the inner liner extends from at least a portion of the inner surface of the inner liner. slidable along a portion, the second longitudinal edge being slidable along at least a portion of the outer surface of the inner liner; The inner surface of the tubular inner liner defines the lumen of the sheath; The tubular inner liner is configured to helically slide a first edge of the inner liner along at least a portion of the inner surface while applying a radial outward force by passing the medical device through a lumen of the inner liner. A sheath configured to expand from a resting diameter ( d _r ) to an expanded diameter ( d _e ) by helically sliding a second edge of the inner liner along at least a portion of the outer surface of the inner liner.

Example 2: The method of any of the embodiments herein, particularly Example 1, wherein the tubular inner liner is configured to expand substantially without a gap being formed between the first longitudinal edge and the second longitudinal edge of the tubular inner liner. Being, sis.

Example 3: The method of any of the embodiments herein, particularly Examples 1 or 2, wherein the tubular inner liner is positioned on the patient's body without forming a gap between the first and second longitudinal edges of the tubular inner liner. A sheath that is configured to bend while passing through native anatomy.

Example 4: The method of any of the embodiments herein, particularly Examples 1 to 3, wherein the longitudinal slit extends from the proximal end of the tubular inner liner to the distal end of the tubular inner liner in a direction offset from the longitudinal axis of the tubular inner liner. Extending to sis.

Example 5: The sheath of any of the examples herein, particularly Example 4, wherein the direction is diagonal from the proximal end of the tubular inner liner to the distal end of the tubular interior.

Example 6: The method of any of the embodiments herein, particularly Examples 4 or 5, wherein the longitudinal slit is located at the proximal end of the tubular inner liner at an angle greater than about 90 degrees or less than about 90 degrees across the length of the tubular inner liner. A sheath extending from the tubular interior to the distal end.

Example 7: The sheath of any of the embodiments herein, particularly Examples 1-3, wherein the longitudinal slits are formed between the proximal end of the tubular inner liner and the distal end of the tubular inner liner in a pattern other than a straight line.

Example 8: The sheath of any of the examples herein, particularly Examples 1 to 7, wherein the helical configuration has a predetermined pitch.

Example 9: The sheath of any of the examples herein, particularly Example 8, wherein the pitch is at least 4 turns per 10 cm of the sheath.

Example 10: The sheath of any of the examples herein, particularly examples 1 to 9, wherein the resting diameter ( d _r ) is substantially uniform along the longitudinal axis of the lumen.

Example 11: According to any of the examples herein, especially Examples 1 to 10, the resting diameter ( d _r ) varies along the longitudinal axis of the lumen, wherein the resting diameter ( d _r ) at the proximal end is at the distal end. Sheath, larger than the resting diameter ( d _r" ) at the end.

Example 12: According to any of the embodiments herein, especially examples 1 to 11, the expanded diameter d _e is configured to receive a medical device passing through the lumen while maintaining the helical configuration of the tubular inner liner. , sis.

Example 13: The method of any of the embodiments herein, particularly Examples 1-12, wherein the sheath maintains the helical configuration of the tubular inner liner, while maintaining the resting diameter ( d _r ) and substantially cis, which contracts to the same diameter.

Example 14: The sheath of any of the examples herein, particularly Examples 1 to 13, wherein the tubular inner liner comprises high density polyethylene, polypropylene, polyamide, fluoropolymer, copolymer thereof, or combinations thereof. .

Example 15: The sheath of any of the examples herein, particularly example 14, wherein the tubular inner liner has a multilayer structure.

Example 16: The sheath of any of the examples herein, particularly examples 1 to 15, wherein the inner surface of the tubular inner liner is at least partially ribbed.

Example 17: The sheath of any of the examples herein, particularly Examples 1-16, wherein the tubular inner liner is lubricious and has a coefficient of friction of less than about 0.5.

Example 18: The sheath of any of the examples herein, particularly Examples 1-17, wherein the sheath further comprises an outer layer.

Example 19: In any of the examples herein, particularly Example 18, the outer layer is a polyether block amide, a styrenic elastomer, a polyurethane, a latex, a copolymer thereof, a blend thereof, or an extrusion thereof. cis, containing water.

Example 20: The sheath of any of the examples herein, particularly Example 19, wherein the outer layer comprises one or more layers.

Example 21: The cis according to any of the examples herein, particularly Example 20, wherein at least one layer comprises a polyether block amide.

Example 22: The sheath of any of the examples herein, particularly Example 21, wherein at least one layer comprises a styrenic elastomer.

Example 23: The sheath of any of the examples herein, particularly Examples 20-22, wherein at least one layer comprises polyurethane.

Example 24: The sheath of any of the examples herein, particularly examples 22 or 23, wherein at least one layer comprises a blend of a styrenic elastomer and a polyurethane.

Example 25: The sheath of any of the examples herein, particularly Examples 22 to 24, wherein the styrenic elastomer has a Shore A hardness of 20A to 50A.

Example 26: The method of any of the examples herein, particularly Examples 18-20, wherein the outer layer comprises a first polymer layer, wherein the first polymer layer comprises a first compound composition, wherein: 1 A first polymer comprising greater than 0% to less than 100% by weight of a polyether block amide, polyurethane, or a combination thereof based on the total weight of the compound composition; Less than about 65% of inorganic filler based on the total weight of the first compound composition; and up to about 20% solid lubricating filler by total weight of the first compound composition; wherein the sheath exhibits at least a 10% reduction in insertion force when compared to a substantially identical reference sheath not comprising the first polymer layer; wherein the outer layer is substantially kink resistant, sheath.

Example 27: The method of any of the examples herein, particularly Example 26, wherein the hardness of the first polymer at the proximal end of the outer layer is different than the hardness of the first polymer at the distal end of the outer layer, and is about 20D. cis, with a Shore D of from about 35D.

Example 28: The cis of any of the examples herein, particularly examples 26 or 27, wherein the first polymer comprises a polyether block amide elastomer.

Example 29: The cis of any of the examples herein, particularly examples 26 or 27, wherein the first polymer comprises polyurethane.

Example 30: For any of the examples herein, particularly Examples 26 to 29, the inorganic filler is selected from the group consisting of bismuth oxychloride, barium sulfate, bismuth subcarbonate, calcium carbonate, aluminum trihydrate, barite, kaolin clay, limestone, or any combination thereof, and is present in an amount of at least about 10% based on the total weight of the first compound composition.

Example 31: The cis of any of the examples herein, particularly Examples 26-30, wherein the inorganic filler is present in an amount of less than about 50% based on the total weight of the first compound composition.

Example 32: The sheath of any of the examples herein, particularly Examples 26-31, wherein the solid lubricant comprises a PTFE filler.

Example 33: The method of any of the examples herein, particularly Examples 26 to 32, wherein the first compound composition is present in at least one compound in an amount of about 1% to about 20% based on the total weight of the first compound composition. cis, further comprising a sticky reducing compound of

Example 34: The sheath of any of the examples herein, particularly Examples 26 to 33, wherein the outer layer comprises two or more polymer layers.

Example 35: The method of any of the examples herein, particularly Example 34, wherein the outer layer contains greater than 0% to 100% by weight of a second polymer comprising at least a polyether block amide, polyurethane, or compositions thereof. comprising a second polymer layer comprising a second compound composition comprising; wherein the second polymer has a Shore A hardness of about 20A to about 65A.

Example 36: The cis of any of the examples herein, particularly Example 35, wherein the second compound composition further comprises up to 20% of a tack reducing additive by total weight of the second compound composition.

Example 37: The cis of any of the examples herein, particularly examples 35 or 36, wherein the second polymer comprises polyurethane.

Example 38: The method of any of the examples herein, particularly Examples 35-37, wherein the outer layer has a predetermined thickness, wherein at least about 50% of the predetermined thickness is comprised of the first and/or second compound composition. Including, cis.

Example 39: The sheath according to any of the examples herein, especially Examples 35 to 38, wherein the one or more additional polymer layers are disposed between the first polymer layer and the second polymer layer.

Example 40: The sheath of any of the examples herein, particularly Example 39, wherein the one or more additional polymeric layers comprise at least one intermediate reinforcing layer extending axially over at least a portion of the length of the outer layer.

Example 41: The sheath of any of the examples herein, particularly Example 40, wherein at least one intermediate reinforcement layer comprises a first polymer, a second polymer, a polyolefin-based polymer, or a combination thereof.

Example 42: The sheath of any of the examples herein, particularly examples 40 or 41, wherein the at least one intermediate reinforcing layer comprises a material having a Shore D hardness of about 45D to about 76D.

Example 43: The sheath of any of the examples herein, particularly Examples 40-42, wherein at least one intermediate reinforcing layer is configured to be thermally bonded to the first polymer layer, the second polymer layer, or a combination thereof. .

Example 44: The sheath of any of the examples herein, particularly Examples 18-43, wherein the sheath further comprises a braided layer disposed between the tubular inner layer and the outer layer.

Example 45: The sheath of any of the examples herein, particularly Example 44, wherein the braided layer is at least partially embedded within the outer layer.

Example 46: The sheath of any of the examples herein, particularly Examples 18-45, wherein the sheath comprises a lubricant at least partially disposed between the tubular inner liner and the outer layer.

Example 47: A method of making a sheath having a proximal end and a distal end, said method comprising: i) an offset direction from the longitudinal axis of an elongated single lumen tube such that a first longitudinal edge and a second longitudinal edge are formed; forming a longitudinal slit by cutting the circumference of the elongated single lumen tube between a proximal end and a distal end of the elongated single lumen tube; ii) at least a portion of the inner surface of the inner liner helically overlaps with at least a portion of the outer surface of the inner liner, wherein the first longitudinal edge of the inner liner is at least a portion of the inner surface of the inner liner and wherein the second longitudinal edge is slidable along at least a portion of an outer surface of the inner liner. forming a tubular inner liner by rolling, wherein the inner surface of the tubular inner liner defines a lumen of the sheath; wherein the tubular inner liner helically slides a first edge of the inner liner along at least a portion of the inner surface while applying a radial outward force by passing the medical device through a lumen of the inner liner. and configured to expand from a resting diameter ( d _r ) to an expanded diameter ( d _e ) by helically sliding a second edge of the inner liner along at least a portion of the outer surface of the inner liner.

Example 48: The method of any of the examples herein, particularly Example 47, wherein the rolling step comprises positioning an elongated single lumen tube with a longitudinal slit on a mandrel having a predetermined diameter to form a helical configuration. A method comprising: wherein the predetermined diameter of the mandrel is substantially equal to the resting diameter (d _r ) of the inner liner.

Example 49: The method of any of the embodiments herein, particularly Examples 47 or 48, wherein the formed tubular inner liner has substantially no gap formed between the first longitudinal edge and the second longitudinal edge of the tubular inner liner. A method configured to be extended.

Example 50: The method of any of the embodiments herein, particularly Examples 47-49, wherein the formed tubular inner liner is capable of supporting the patient without forming a gap between the first and second longitudinal edges of the tubular inner liner. A method configured to bend while passing through the native anatomy of.

Example 51: The method of any of the examples herein, particularly Examples 47-50, wherein the offset direction is diagonal from the proximal end of the tubular inner liner to the distal end of the tubular interior.

Example 52: The method of any of the embodiments herein, particularly Examples 47-51, wherein the longitudinal slit is located at the proximal end of the tubular inner liner at an angle greater than about 90 degrees or less than about 90 degrees across the length of the tubular inner liner. extending from the tubular interior to the distal end.

Example 53: The method of any of the examples herein, particularly Examples 47-50, wherein the longitudinal slits are formed between the proximal end of the tubular inner liner and the distal end of the tubular inner liner in a pattern other than a straight line.

Example 54: The method of any of the examples herein, particularly Examples 47-53, wherein the helical configuration has a predetermined pitch.

Example 55: The method of any of the examples herein, particularly Example 54, wherein the pitch is at least 4 turns per 10 cm of sheath.

Example 56: The method of any one of clauses 47-55, wherein the resting diameter ( d _r ) is substantially uniform along the longitudinal axis of the lumen.

Example 57: The method of any of the examples herein, particularly Examples 47-56, wherein the resting diameter ( d _r ) varies along the longitudinal axis of the lumen, wherein the resting diameter ( d _r ) at the proximal end is at the distal end. greater than the resting diameter ( d _r" ) at the end, method.

Example 58: The method of any of the embodiments herein, particularly examples 47 to 57, wherein the expanded diameter d _e is configured to receive a medical device passing through the lumen while maintaining the helical configuration of the tubular inner liner. , method.

Example 59: The method of any of the embodiments herein, particularly Examples 47-58, wherein the sheath maintains the helical configuration of the tubular inner liner, while maintaining the resting diameter ( d _r ) and substantially How to shrink to the same diameter.

Example 60: The method of any of the examples herein, particularly Examples 47-59, wherein the tubular inner liner comprises high density polyethylene, polypropylene, polyamide, fluoropolymer, copolymer thereof, or combinations thereof. .

Example 61: The method of any of the examples herein, particularly Example 60, wherein the tubular inner liner has a multilayer structure.

Example 62: The method according to any one of the examples herein, particularly Examples 47 to 61, wherein the inner surface of the tubular inner liner is at least partially ribbed.

Example 63: The method of any of the examples herein, particularly Examples 47-62, wherein the tubular inner liner is lubricious and has a coefficient of friction of less than about 0.5.

Example 64: The method of any of the examples herein, particularly Examples 47-63, further comprising disposing an outer layer over at least a portion of the outer surface of the inner liner .

Example 65: In any of the examples herein, particularly Example 64, the outer layer is a polyether block amide, a styrenic elastomer, a polyurethane, a latex, a copolymer thereof, a blend thereof, or an extrusion thereof. Method containing water.

Example 66: The method of any of the examples herein, particularly Example 65, wherein the outer layer comprises one or more layers.

Example 67: The method of any of the examples herein, particularly Example 66, wherein at least one layer comprises a polyether block amide.

Example 68: The method of any of the examples herein, particularly Example 67, wherein at least one layer comprises a styrenic elastomer.

Example 69: The method of any of the examples herein, particularly Examples 66-68, wherein at least one layer comprises polyurethane.

Example 70: The method of any of the examples herein, particularly examples 68 or 69, wherein at least one layer comprises a blend of a styrenic elastomer and a polyurethane.

Example 71: The method of any of the examples herein, particularly Examples 68-70, wherein the styrenic elastomer has a Shore A hardness of 20A to 50A.

Example 72: The method of any of the examples herein, particularly Examples 64-66, wherein the outer layer comprises a first polymer layer, wherein the first polymer layer comprises a first compound composition, wherein: 1 A first polymer comprising greater than 0% to less than 100% by weight of a polyether block amide, polyurethane, or a combination thereof based on the total weight of the compound composition; Less than about 65% of inorganic filler based on the total weight of the first compound composition; and up to about 20% of a solid lubricating filler by total weight of the first compound composition; wherein the sheath exhibits at least a 10% reduction in insertion force when compared to a substantially identical reference sheath not comprising the first polymer layer; wherein the outer layer is substantially kink resistant.

Example 73: The method of any of the examples herein, particularly Example 72, wherein the hardness of the first polymer at the proximal end of the outer layer is different than the hardness of the first polymer at the distal end of the outer layer, and is about 20D. A method having a Shore D of from about 35D.

Example 74: The method of any of the examples herein, particularly examples 72 or 73, wherein the first polymer comprises a polyether block amide elastomer.

Example 75: The method of any of the examples herein, particularly Examples 72-74, wherein the first polymer comprises polyurethane.

Example 76: For any of the examples herein, especially Examples 72 to 75, the inorganic filler is selected from the group consisting of bismuth oxychloride, barium sulfate, bismuth subcarbonate, calcium carbonate, aluminum trihydrate, barite, kaolin clay, limestone, or any combination thereof, and is present in an amount of at least about 10% based on the total weight of the first compound composition.

Example 77: The method of any of the examples herein, particularly Examples 72-76, wherein the inorganic filler is present in an amount less than about 50% based on the total weight of the first compound composition.

Example 78: The method of any of the examples herein, particularly Examples 72-77, wherein the solid lubricant comprises a PTFE filler.

Example 79: The method of any of the examples herein, particularly Examples 72 to 78, wherein the first compound composition is present in an amount of about 1% to about 20% based on the total weight of the first compound composition. A method further comprising a stickiness reducing compound.

Example 80: The method of any of the examples herein, particularly Examples 72-79, wherein the outer layer comprises two or more polymer layers.

Example 81: The method of any of the examples herein, particularly Example 80, wherein the outer layer contains greater than 0% to 100% by weight of a second polymer comprising at least a polyether block amide, polyurethane, or compositions thereof. comprising a second polymer layer comprising a second compound composition comprising; wherein the second polymer has a Shore A hardness of about 20A to about 65A.

Example 82: The method of any of the examples herein, particularly Example 81, wherein the second compound composition further comprises up to 20% of a tack reducing additive by total weight of the second compound composition.

Example 83: The method of any of the examples herein, particularly examples 81 or 82, wherein the second polymer comprises polyurethane.

Example 84: The method of any of the examples herein, particularly Examples 81-83, wherein the outer layer has a predetermined thickness, wherein at least about 50% of the predetermined thickness is comprised of the first and/or second compound composition. Including, method.

Example 85: The method of any of the examples herein, particularly examples 81 to 84, wherein the one or more additional polymer layers are disposed between the first polymer layer and the second polymer layer.

Example 86: The method of any of the examples herein, particularly Example 85, wherein the one or more additional polymer layers comprise at least one intermediate reinforcing layer extending axially over at least a portion of the length of the outer layer.

Example 87: The method of any of the examples herein, particularly Example 86, wherein the at least one intermediate reinforcement layer comprises a first polymer, a second polymer, a polyolefin-based polymer, or a combination thereof.

Example 88: The method of any of the examples herein, particularly examples 86 or 87, wherein the at least one intermediate reinforcing layer comprises a material having a Shore D hardness of about 45D to about 76D.

Example 89: The method of any of the examples herein, particularly Examples 86 to 88, wherein the at least one intermediate reinforcement layer is configured to be thermally bonded to the first polymer layer, the second polymer layer, or a combination thereof. .

Example 90: The method of any of the examples herein, particularly Examples 64-89, further comprising disposing the braided layer on at least a portion of the outer surface of the tubular inner liner prior to disposing the outer layer. Including, method.

Example 91: The method of any of the examples herein, particularly Example 90, further comprising disposing an outer layer over the braided layer and at least partially embedding the braided layer within the outer layer. .

Example 92: The method of any of the examples herein, particularly Examples 64-90, wherein the method comprises disposing a lubricant on at least a portion of the outer surface of the inner liner prior to disposing the outer layer. , method.

Example 93: The method of any of the examples herein, particularly Examples 90-92, wherein the method comprises: at least a portion of the outer surface of the inner liner prior to disposing the braided layer or after disposing the braided layer; A method comprising disposing a lubricant on the bed.

Example 94: A method of delivering a prosthetic device to a surgical site, comprising: inserting the expandable sheath, at least partially, into the patient's vasculature, the expandable sheath of any of the embodiments herein, particularly Examples 1-46. steps; Locally expanding the tubular liner by sliding the first and second longitudinal edges during passage of the artificial device, and locally folding the sheath at least partially back from a locally expanded state to an unexpanded state after passage of the artificial device. A method comprising steps.

Example 95: The method of any of the examples herein, particularly Example 94, wherein during the step of locally expanding the tubular liner, substantially no gap is formed between the first and second longitudinal edges.

Example 96: The method of any of the examples herein, particularly Examples 94 or 95, wherein advancing the prosthetic device comprises advancing the prosthetic heart valve through the inner lumen of the inner liner of the sheath. How to deliver.

Example 97: The prosthetic device of any of the embodiments herein, particularly Example 96, further comprising introducing the prosthetic heart valve into the treatment site and expanding the prosthetic heart valve within the treatment site. How to deliver.

Claims (36)

1. A sheath for delivering a medical device, the sheath having a proximal end and a distal end,
a tubular inner liner comprising a tubular inner liner having a longitudinal slit extending along a length of the tubular inner liner such that the tubular liner is wound in a helical scroll configuration;
wherein the longitudinal slits define a first longitudinal edge and a second longitudinal edge of the tubular inner liner;
In the helical scroll configuration, at least a portion of an inner surface of the inner liner helically overlaps at least a portion of an outer surface of the inner liner, and a first longitudinal edge of the inner liner extends from at least a portion of the inner surface of the inner liner. slidable along a portion, the second longitudinal edge being slidable along at least a portion of the outer surface of the inner liner;
The inner surface of the tubular inner liner defines the lumen of the sheath;
The tubular inner liner is configured to helically slide a first edge of the inner liner along at least a portion of the inner surface while applying a radial outward force by passing the medical device through a lumen of the inner liner. A sheath configured to expand from a resting diameter ( d _r ) to an expanded diameter ( d _e ) by helically sliding a second edge of the inner liner along at least a portion of the outer surface of the inner liner. The sheath of claim 1 , wherein the tubular inner liner is configured to expand substantially without a gap being formed between the first longitudinal edge and the second longitudinal edge of the tubular inner liner. 3. The method of claim 1 or 2, wherein the tubular inner liner is configured to bend while passing through the patient's native anatomy without forming a gap between the first and second longitudinal edges of the tubular inner liner. , sis. The sheath of any preceding claim, wherein the longitudinal slit extends from the proximal end of the tubular inner liner to the distal end of the tubular inner liner in a direction offset from the longitudinal axis of the tubular inner liner. The sheath of claim 4, wherein the direction is diagonal from the proximal end of the tubular inner liner to the distal end of the tubular interior. 6. The method of claim 4 or 5, wherein the longitudinal slit extends from the proximal end of the tubular inner liner to the distal end of the tubular inner liner at an angle greater than about 90 degrees or less than about 90 degrees across the length of the tubular inner liner. Being, sis. The sheath according to claim 1 , wherein the longitudinal slits are formed between the proximal end of the tubular inner liner and the distal end of the tubular inner liner in a pattern other than a straight line. The sheath according to any one of claims 1 to 7, wherein the helical configuration has a predetermined pitch. The sheath of claim 8, wherein the pitch is at least 4 turns per 10 cm of the sheath. The sheath of any one of claims 1 to 9, wherein the tubular inner liner comprises high density polyethylene, polypropylene, polyamide, fluoropolymer, copolymers thereof, or combinations thereof. 11. Sheath according to any one of claims 1 to 10, wherein the inner surface of the tubular inner liner is at least partially ribbed. 12. The sheath of any preceding claim, wherein the tubular inner liner is lubricious and has a coefficient of friction of less than about 0.5. 13. The sheath according to any one of claims 1 to 12, wherein the sheath further comprises an outer layer. 14. The sheath of claim 13, wherein the outer layer comprises polyether block amide, styrenic elastomer, polyurethane, latex, copolymers thereof, blends thereof, or extrudates thereof. 15. The sheath of claim 14, wherein the outer layer comprises one or more layers. 16. The cis of claim 15, wherein at least one layer comprises a polyether block amide. 17. The sheath of claim 16, wherein at least one layer comprises a styrenic elastomer. 18. Sheath according to any one of claims 15 to 17, wherein at least one layer comprises polyurethane. 19. The sheath of claim 17 or 18, wherein at least one layer comprises a blend of a styrenic elastomer and a polyurethane. 16. The method of any one of claims 13 to 15, wherein the outer layer comprises a first polymer layer, wherein the first polymer layer comprises a first compound composition, wherein the first compound composition comprises:
A first polymer comprising greater than 0% to less than 100% by weight of polyether block amide, polyurethane, or a combination thereof based on the total weight of the first compound composition;
less than about 65% of inorganic filler based on the total weight of the first compound composition; and
comprising up to about 20% solid lubricant filler based on the total weight of the first compound composition;
wherein the sheath exhibits at least a 10% reduction in insertion force when compared to a substantially identical reference sheath not comprising the first polymer layer; wherein the outer layer is substantially kink resistant, sheath. 21. The cis of claim 20, wherein the first polymer comprises a polyether block amide elastomer or a polyurethane. 22. The method of claim 20 or 21, wherein the inorganic filler is bismuth oxychloride, barium sulfate, bismuth subcarbonate, calcium carbonate, aluminum trihydrate, barite, kaolin clay, limestone, or any combination thereof. cis, comprising and present in an amount of at least about 10% based on the total weight of the first compound composition. 23. The sheath of any one of claims 20-22, wherein the solid lubricant comprises PTFE filler. 24. The method of any one of claims 20 to 23, wherein the first compound composition further comprises at least one tackiness reducing compound present in an amount of about 1% to about 20% based on the total weight of the first compound composition. Including, cis. 25. The sheath according to any one of claims 20 to 24, wherein the outer layer comprises two or more polymer layers. 26. The second polymer of claim 25, wherein the outer layer comprises a second compound composition comprising greater than 0% to 100% by weight of a second polymer comprising at least a polyether block amide, a polyurethane, or a composition thereof. Contains layers; wherein the second polymer has a Shore A hardness of about 20A to about 65A. 27. The sheath of claim 26, wherein the second compound composition further comprises up to 20% of a tack reducing additive by total weight of the second compound composition. 28. The cis of any one of claims 26 or 27, wherein the second polymer comprises polyurethane. 29. The sheath of any one of claims 26-28, wherein the outer layer has a predetermined thickness, wherein at least about 50% of the predetermined thickness comprises the first and/or second compound composition. 30. The sheath according to any one of claims 26 to 29, wherein at least one additional polymer layer is disposed between the first polymer layer and the second polymer layer. 31. The sheath of claim 30, wherein the one or more additional polymeric layers comprise at least one intermediate reinforcing layer extending axially over at least a portion of the length of the outer layer. 32. The sheath of claim 31, wherein at least one intermediate reinforcement layer comprises a first polymer, a second polymer, a polyolefin-based polymer, or a combination thereof. The sheath of claim 31 , wherein the at least one intermediate reinforcement layer is configured to be thermally bonded to the first polymer layer, the second polymer layer, or a combination thereof. 34. The sheath of any one of claims 13 to 33, wherein the sheath further comprises a braided layer disposed between the tubular inner layer and the outer layer. 35. The sheath of claim 34, wherein the braided layer is at least partially embedded within the outer layer. 36. The sheath of any one of claims 13-35, wherein the sheath comprises a lubricant at least partially disposed between the tubular inner liner and the outer layer.