US20130310765A1 - Valve for dilator and sheath assembly - Google Patents
Valve for dilator and sheath assembly Download PDFInfo
- Publication number
- US20130310765A1 US20130310765A1 US13/832,294 US201313832294A US2013310765A1 US 20130310765 A1 US20130310765 A1 US 20130310765A1 US 201313832294 A US201313832294 A US 201313832294A US 2013310765 A1 US2013310765 A1 US 2013310765A1
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- United States
- Prior art keywords
- valve
- hub
- sheath
- dilator
- proximal
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
- A61M25/0668—Guide tubes splittable, tear apart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0097—Catheters; Hollow probes characterised by the hub
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M39/0606—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof without means for adjusting the seal opening or pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
- A61M2025/0681—Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
- A61M2039/064—Slit-valve
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
- A61M2039/066—Septum-like element
Definitions
- FIG. 11 is a cross-sectional view along the line 11 - 11 in FIG. 10 .
- FIG. 16 is a side elevation view of the exemplary valve of FIG. 13 .
- FIG. 22 is a cross-sectional view along the line 22 - 22 in FIG. 20 .
- distal and proximal refer to the directions “away from” and “closer to,” respectively, the body of the physician inserting the dilator and sheath assembly into a patient.
- slot refers to a separation of material of a body which extends only partially through the body and does not exit out an opposite surface of the body and the term “slit” refers to a separation of material of a body which passes through the body from one surface out the other surface.
- the terminology includes the words above specifically mentioned, derivatives thereof, and words of similar import. The following describes a preferred embodiment of the present invention. However, it should be understood, based on this disclosure, that the invention is not limited by the preferred embodiment described herein.
- the sheath assembly 40 extends between a proximal end 41 and a distal end 43 and includes a sheath body 44 , a sheath hub 50 , a valve 80 and cap members 100 .
- a through passage 42 extends through the sheath body 44 and sheath hub 50 from the distal end 43 to the proximal end 41 .
- the through passage 42 is sealed by the valve 80 as described in more detail hereinafter.
- the slot 83 terminates prior to the distal surface 94 such that the body halves 82 a and 82 b are joined by a bridging portion 84 along the distal surface 94 .
- the bridging portion 84 has a reduced thickness t relative to the total thickness T of the valve body 82 .
- the thickness t of the bridging portion is between approximately 0.002 to 0.006 inches and more preferably between approximately 0.003 to 0.004 inches.
- the valve body thickness may be about 0.1 inches.
- the proximal surface 86 defines an outer annular planar portion 87 that is substantially perpendicular to the longitudinal axis L when the valve is assembled within the sheath hub 50 (see FIGS. 29 and 30 ).
- An annular groove 88 is defined along the planar portion 87 and is configured to receive a retaining ridge 116 of the cap members 100 and also facilitates hinging of a center portion of the valve body 82 as an item is passed through the valve 80 , as described in more detail below.
- a plurality of alignment holes 98 extend from the distal surface 94 to the proximal surface 86 are defined circumferentially spaced about the planar portion 87 . While the alignment holes 98 are illustrated extending completely through the body 82 , such is not required. Alternatively, the alignment holes 98 may be formed as blind holes opening at the distal surface 94 .
- the proximal surface 86 defines a conical portion 89 which tapers to a central blind bore 90 .
- the bore 90 terminates in a bottom surface 91 that is spaced from the body distal surface 94 such that the bore 90 does not pass completely through the valve body 82 .
- the bore 90 may be formed with a narrowing taper from the entrance at the conical portion 89 to the bottom surface 91 .
- the conical portion 89 and the bore 90 serve to guide a guidewire (not shown), the dilator distal tip 37 , the catheter tip (not shown), or any other instrument as they are respectively passed through the valve 80 .
- the dilator 20 may be inserted therein and locked in place by engagement of the locking portions 39 , 129 as described with reference to FIGS. 31-33 .
- the dilator stem 36 is passed through the opening 111 defined by the cap members 100 and then through the valve 80 (not shown in FIG. 31 ) and into the sheath body 44 .
- the dilator 20 is oriented such that the dilator hub platform 32 is transverse to the direction of the flanges 114 of the cap members 100 . With this orientation, the dilator stem 36 may be fully inserted with the cap member walls 110 received between the engagement portions 34 of the dilator hub 22 as shown in FIG. 32 .
- the engagement portions 34 contact the cap member platforms 102 upon full insertion.
Abstract
Description
- This application claims the benefit of U.S. Provisional Appln. No. 61/648,132 filed on May 17, 2012 and U.S. Provisional Appln. No. 61/725,509 filed on Nov. 13, 2012, both of which are incorporated herein by reference.
- This invention relates to invasive medical devices which aid in the catheterization of human blood vessels. In particular, this invention relates to a releasably locking dilator and tear away sheath assembly, which is used to enlarge an opening in a patient's blood vessel during insertion of a catheter into the blood vessel and then guide the catheter into the blood vessel to be catheterized.
- Catheters are used in numerous medical procedures. In particular, catheters are used for the introduction or removal of fluids from various venous regions and vessels throughout the body, such as for hemodialysis. The procedure by which these catheters are introduced to the body is delicate and complex. One particularly intricate challenge to catheterization is enlarging a hole in the flesh and vessel to be catheterized while minimizing blood loss and trauma to the patient.
- Generally, to insert any catheter in a blood vessel, the vessel is identified by aspiration with a long hollow needle in accordance with the Seldinger technique. When blood enters a syringe attached to the needle, indicating that the vessel has been found, a thin guide wire is then introduced, typically through the syringe needle or other introducer device, into the interior of the vessel. The introducer device is then removed, leaving the guide wire within the vessel. The guide wire projects beyond the surface of the skin.
- At this point, several options are available to a physician for catheter placement. The simplest option is to pass a catheter into the vessel directly over the guide wire. The guide wire is then removed. However, use of this technique is only possible in cases where the catheter is of a relatively small diameter, made of a stiff material and not significantly larger than the guide wire. If, however, the catheter is of a relatively large diameter and/or made of a soft material, one preferable method of inserting the catheter into the vessel is through an introducer sheath. The introducer sheath is simply a large, stiff, thin-walled tube, which serves as a temporary conduit for the catheter that is being placed. The sheath is positioned by placing a dilator, which has a hollow passageway along its longitudinal axis, inside of the sheath and passing both the dilator and the sheath together into the vessel over the guide wire. The dilator expands the opening in the blood vessel to allow for catheter insertion into the vessel. The guide wire and dilator are then removed, leaving the thin-walled sheath in place. The catheter is then inserted into the vessel through the sheath.
- In a setting where a catheter with a hub or other attachment at the proximal end of the catheter has a feature which is larger than that of the inner diameter of the sheath, it is necessary to have a tear-away sheath that can be split away from the catheter as the sheath is being removed from the patient. By splitting the sheath along its longitudinal axis as the sheath is being removed from the patient, the inserting physician will be able to pull out the sheath in such a way that the portion removed from the patient is split, thereby not interfering with any encumbrances on the catheter. Generally, tear away sheaths are manufactured in a way that aids in the tearing of the sheath at two opposing points on the circumference of the sheath, thereby splitting the sheath into two halves separated longitudinally through the center of the sheath.
- A sheath is generally constructed with a hub at its proximal end. This hub serves as a handle, a mating point for a dilator, and a flat surface to aid in the prevention of blood loss or contamination. When a sheath needs to be split apart in order to be successfully withdrawn from the body while leaving the catheter in place, the hub will also have to be split apart in order to clear the catheter. Preferably, the hub will split along the same lines as the sheath. To accomplish this, the hub must be designed with reveals or other weaknesses along two longitudinal lines aligned with the weaknesses in the sheath. Some previous examples of these weaknesses are tabs or webs which connect two halves of the hub, or recesses in the material comprising the hub. The weaknesses in the hub will help the inserting physician to break apart the hub in line with the tear seams on the sheath.
- Another important facet of the hub is a set of tabs that protrude from the center. These tabs not only help the inserting physician to align, insert and withdraw the sheath, but also to pull the sheath so that the sheath can be removed from around a catheter while still leaving the catheter in place. There are a number of different tab configurations, but it is important to have one which allows for easy maneuverability, control, and leverage. One design includes a hub wherein the tabs protrude from the hub perpendicular to a plane which includes the tear seams in the sheath and the longitudinal axis of the sheath. In this design, the tabs are diametrically opposed from each other and are spaced in such a way that when the tabs are grasped and pulled apart from each other, the sheath and its hub will split down the middle. Another desirable feature of the tabs is that the tabs provide leverage for breaking apart the hub in a manner that does not cause trauma to the incision in the body.
- During insertion, especially in the time between the removal of the dilator from the sheath and the insertion of the catheter through the sheath, it is possible for blood loss through the sheath, or the introduction of contaminants or air through the sheath and into the vessel. For this reason, it is desirable that measures be taken to prevent blood, air or contaminants from traveling through the sheath. In the past, inserting physicians have simply held their thumb over the opening in the proximal end of the sheath; however, a more permanent and reliable means for preventing blood, air or contaminants from traveling through the sheath is desirable. It is therefore desirable for the hub to include a valve located in the sheath. Such a valve would facilitate the insertion of objects such as a catheter or dilator through the sheath while restricting blood loss and reducing the chance of contaminants entering the patient's bloodstream when the sheath is not engaged with a dilator or a catheter.
- The dilator has a long tubular section, the outside diameter of which is slightly smaller than the inside diameter of the sheath. The dilator also has a pointed tip on its distal end and a hollow center, which runs along the entire length of the dilator. The dilator is inserted into the body with the guidewire running through its center, thereby allowing the tip of the dilator to follow the guidewire to the place that is to be catheterized. On its proximal end, the dilator may have a hub. Like the hub of the sheath, this hub can also serve a number of purposes, such as providing a stable handle to aid in guiding the dilator into the vein, and as a mechanism which can mate with the sheath hub to form a locked connection.
- Some dilator and sheath assemblies that include a connection between the dilator and sheath are known. U.S. Pat. No. 5,885,217 to Gisselberg et al. discloses a dilator and sheath assembly, wherein the dilator and sheath are held together by locking tabs which provide a stop to hold the dilator in place during insertion. However, in this configuration, the dilator may rotate about its longitudinal axis in relation to the sheath, thereby inadvertently and prematurely disengaging the dilator from the sheath. U.S. Pat. No. 5,098,392 to Fleischhacker et al. discloses a dilator and sheath assembly, wherein the dilator is attached to the sheath through a clamp wherein the clamp is part of the dilator hub. However, this design presents the ability to come unclamped leading to the dilator backing out of the sheath. U.S. Pat. No. 4,772,266 to Groshong discloses a dilator and sheath assembly, wherein the hubs of the dilator and the sheath lock together by means of compression. However, it would be possible for the dilator to back out of the sheath in this configuration if excessive force is exerted on the tip of the dilator.
- It would be beneficial to provide a dilator and sheath assembly that incorporates a stable releasably locking mechanism to prevent the dilator from backing out of the sheath longitudinally during insertion which is not prone to coming unlocked or releasing during use. It would also be beneficial for the sheath of the dilator and sheath assembly to have a means for sealing the passageway to the patient's vessel, thereby restricting blood loss and reducing the introduction of contaminants into the bloodstream.
- Briefly, the present invention provides a releasably locking dilator and sheath assembly and methods for releasing the dilator from the sheath and longitudinally splitting the sheath in the course of inserting a catheter into a desired vessel to be catheterized.
- In one aspect, the invention provides a valve for sealing the hub of a sheath assembly, the valve comprising a valve body with a bisecting slot extending into a proximal surface of the valve body and terminating at a depth less than the thickness of the valve body such that the remaining portion of the valve body distally of the slot defines a bridge extending between opposed halves of the valve body such that a distal surface of the valve body is substantially continuous.
- In another aspect, the invention provides a sheath assembly including an elongated hollow sheath body having a proximal body end, a distal body end, and a longitudinal axis extending between the proximal body end and the distal body end. A sheath hub is fixedly connected to the proximal body end and includes a hub proximal end and a hub distal end with a through passage extending from the hub distal end to the hub proximal end and in communication with the hollow sheath body. The sheath hub further defining a valve seat proximate the hub proximal end. A valve is seated in the valve seat and includes a valve body with a bisecting slot extending into a proximal surface of the valve body and terminating at a depth less than the thickness of the valve body such that the remaining portion of the valve body distally of the slot defines a bridge extending between opposed halves of the valve body such that a distal surface of the valve body is substantially continuous, the valve extending across and sealing the through passage.
- In a further aspect, the sheath body of the sheath assembly includes at least one tear seam extending in a plane between the proximal body end and the distal body end and the sheath hub includes at least one longitudinal notch, and the at least one tear seam, the at least one longitudinal notch and the bisecting slot are co-planar.
- In another aspect, the invention provides a dilator and sheath assembly. The dilator includes an elongated dilator stem having a proximal dilator end and a dilator hub fixedly connected to the proximal dilator end, wherein the dilator hub includes a locking portion at a distal portion thereof. The sheath assembly includes an elongated tubular portion having a proximal sheath end, a distal sheath end, and a longitudinal axis extending between the proximal sheath end and the distal sheath end, wherein the tubular portion is sized to receive the dilator stem and includes at least one tear seam extending in a plane between the proximal sheath end and the distal sheath end. A sheath hub is fixedly connected to the proximal sheath end. A valve is assembled to the sheath hub proximal of the proximal sheath end and at least one cap member is secured to the sheath hub proximal portion. The at least one cap member defines a mating locking portion wherein the locking portion of the dilator hub and the mating locking portion of the cap provide a releasably locking engagement between the dilator and the sheath.
- The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings:
-
FIG. 1 is a perspective view of a releasably locking dilator and sheath assembly in a locked state in accordance with an embodiment of the present invention. -
FIG. 2 is an exploded perspective view of the assembly ofFIG. 1 . -
FIG. 3 is a perspective view of an exemplary dilator hub in accordance with an embodiment of the invention. -
FIG. 4 is a cross-sectional view along the line 4-4 inFIG. 3 . -
FIG. 5 is a top perspective view of an exemplary sheath hub in accordance with an embodiment of the invention. -
FIG. 6 is a bottom perspective view of the exemplary sheath hub ofFIG. 5 . -
FIG. 7 is a cross-sectional view along the line 7-7 inFIG. 5 . -
FIG. 8 is a top perspective view of an exemplary valve in accordance with an embodiment of the invention. -
FIG. 9 is a bottom perspective view of the exemplary valve ofFIG. 8 . -
FIG. 10 is a top plan view of the exemplary valve ofFIG. 8 . -
FIG. 11 is a cross-sectional view along the line 11-11 inFIG. 10 . -
FIG. 12 is a cross-sectional view along the line 12-12 inFIG. 10 . -
FIG. 13 is a perspective view of another exemplary valve in accordance with an embodiment of the invention. -
FIG. 14 is a top perspective view of the exemplary valve ofFIG. 13 . -
FIG. 15 is a bottom perspective view of the exemplary valve ofFIG. 13 . -
FIG. 16 is a side elevation view of the exemplary valve ofFIG. 13 . -
FIG. 17 is a cross-sectional view along the line 17-17 inFIG. 13 . -
FIG. 18 is a cross-sectional view along the line 18-18 inFIG. 13 . -
FIG. 19 is an expanded view of a portion of the valve ofFIG. 18 . -
FIG. 20 is a top perspective view of another exemplary valve in accordance with an embodiment of the invention. -
FIG. 21 is a side elevation view of the exemplary valve ofFIG. 20 . -
FIG. 22 is a cross-sectional view along the line 22-22 inFIG. 20 . -
FIG. 23 is a bottom perspective view of the exemplary valve ofFIG. 20 . -
FIG. 24 is a cross-sectional view along the line 24-24 inFIG. 23 . -
FIG. 25 is a front perspective view of an exemplary cap member in accordance with an embodiment of the invention. -
FIG. 26 is a rear perspective view of the exemplary cap member ofFIG. 25 . -
FIG. 27 is a perspective view of the exemplary hub assembly in an assembled condition with the sheath omitted. -
FIG. 28 is a perspective cross-sectional view along the line 28-28 inFIG. 27 . -
FIG. 29 is a planar view of the cross-sectional view ofFIG. 28 . -
FIG. 30 is a cross-sectional view along the line 30-30 inFIG. 27 . -
FIGS. 31-33 are perspective views of the releasably locking dilator and the sheath assembly sequentially illustrating positioning and locking of the dilator relative to the sheath assembly. - In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The terms “distal” and “proximal” refer to the directions “away from” and “closer to,” respectively, the body of the physician inserting the dilator and sheath assembly into a patient. As used herein, the term “slot” refers to a separation of material of a body which extends only partially through the body and does not exit out an opposite surface of the body and the term “slit” refers to a separation of material of a body which passes through the body from one surface out the other surface. The terminology includes the words above specifically mentioned, derivatives thereof, and words of similar import. The following describes a preferred embodiment of the present invention. However, it should be understood, based on this disclosure, that the invention is not limited by the preferred embodiment described herein.
- Referring to
FIGS. 1 and 2 , an exemplary embodiment of a releasably locking dilator andsheath assembly 10 is shown. Theassembly 10 generally includes adilator 20 and asheath assembly 40, which are releasably lockable to each other. Thedilator 20 is longer than thesheath assembly 40 so that thedilator 20, in the releasably locked position as shown inFIG. 1 , passes through thesheath assembly 40 so that adistal tip 37 of thedilator 20 extends beyond thedistal end 46 of thesheath assembly 40. - Referring to
FIGS. 1-4 , thedilator 20 is an elongated device that includes aproximal end 21, adistal end 35 with astem 36 anddilator hub 22 extending between theproximal end 21 and thedistal end 35. At thedistal end 35 of thedilator stem 36, atransition portion 38 reduces in diameter to a conically shaped, opendistal tip 37. When in a releasably connected state with thedilator 20 inside of thesheath assembly 40, thedilator 20 andsheath assembly 40 share the same longitudinal axis “L”. The exterior diameter of thestem 36 of thedilator 20 is sized to allow a slight frictional engagement between the inside of thedistal end 46 of thesheath body 44 and the outside of thedilator stem 36. This frictional engagement serves to form a seal between thedilator 20 and thesheath assembly 40 and reduce or prevent blood seepage through thesheath assembly 40 while thedilator 20 is releasably connected thereto. Preferably, thedilator 20 includes ahollow passageway 30 along the length of thedilator 20 from thedistal tip 37 to the proximal end of thedilator hub 22. Thehollow passageway 30 allows thedilator 20 to be inserted over a guidewire (not shown) and follow the guidewire to the desired position inside the vessel to be catheterized. - The
proximal end 21 of thedilator 20 comprises adilator hub 22 fixedly connected to the dilator stem 36 such as by an adhesive, ultrasonic bonding, insert molding or another method known to those skilled in the art. Thedilator hub 22 includes abody 24 extending between aproximal end 26 and adistal end 28. Theproximal end 26 includes aconnector 27, for example, the male portion of a luer connector. Theconnector 27 may be used as a temporary fitting for any apparatus (not shown) that may be required to be attached to thedilator 20. Thedistal end 28 of thedilator hub 22 includes aconnector ring 29 configured to receive a proximal end of thestem 36 whereat thestem 36 is fixedly connected to thehub 22. Alternatively, thering 29 may be received within thestem 36 and fixedly connected. - A locking
portion 39 extends from thehub body 24 adjacent to thedistal end 28 of thehub 22. The lockingportion 39 of the present embodiment includes anelongate platform 32 extending radially from thehub body 24. Theplatform 32 preferably has a length larger than its width such that theplatform 32 extends from opposed sides of thehub body 24. Anextension portion 33 extends from each end of theplatform 32, extending substantially parallel to the axis L.An engagement portion 34 extends perpendicularly from eachextension portion 33 substantially parallel to theplatform 32 such that lockinggrooves 45 are defined on opposite sides of thehub body 24. The inside surfaces of theextension portions 33 are spaced from one another a distance F while theengagement portions 34 are spaced from one another by a distance E. Preferably, astop member 25 depends from each side edge of theplatform 32. The lockingportion 39 is configured to engage a portion of thesheath assembly 40 to lock thedilator 20 relative thereto, as will be described in more detail hereinafter. - Referring to
FIGS. 1 and 2 , thesheath assembly 40 is used to aid in the insertion of a catheter (not shown) into a vessel (not shown) to be catheterized, as is well known in the art. Since thesheath assembly 40 includes asheath body 44 which is generally more rigid than a catheter, thesheath assembly 40 can be maneuvered into place with less effort and trauma to the patient than a catheter. The catheter is then inserted into the vessel through thesheath assembly 40. Once the catheter is in place, thesheath assembly 40 may be removed, thereby leaving the catheter in its desired position. If thesheath assembly 40 has any encumbrance, such as a hub, on its proximal end, thesheath assembly 40 will have to be split in order to remove it from the patient's body while leaving the catheter in place. - In the present embodiment, the
sheath assembly 40 extends between a proximal end 41 and adistal end 43 and includes asheath body 44, asheath hub 50, avalve 80 andcap members 100. A throughpassage 42 extends through thesheath body 44 andsheath hub 50 from thedistal end 43 to the proximal end 41. The throughpassage 42 is sealed by thevalve 80 as described in more detail hereinafter. - The
sheath body 44 is a hollow tubular member which preferably has a tapereddistal end 46. At least onetear seam 48 is longitudinally disposed along the entire length of thesheath body 44. In this preferred embodiment, twotear seams 48 are present. The tear seams 48 are located on opposite sides of thesheath body 44 such that a plane extending through the twotear seams 48 bisects thesheath body 44 longitudinally. Preferably, the plane contains the longitudinal axis L. The proximal end of thesheath body 44 is fixedly connected to the distal end of thesheath hub 50. - Referring to
FIGS. 5-7 , thesheath hub 50 includes aconical body 52 which tapers from a wider proximal end 51 to a narrowerdistal end 53. Two diametricallyopposed notches 54 are defined longitudinally along thehub body 52 from thedistal end 53 to the proximal end 51. At the radial inner end of eachnotch 54, abridge 55 extends between the twoopposed halves body 52. Thehub body 52 is preferably molded as a unitary component with thebridges 55 extending between thehalves notches 54 preformed, however, thehub body 52 may be otherwise formed. For example, the body halves 52 a, 52 b may be formed as separate components which are joined by thebridges 55 after formation. Alternatively, thebody 52 may be formed as a unitary structure without any notches and the notches are formed through a post molding process, leaving just thebridges 55 extending between thehalves continuous bridges 55 are illustrated, the invention is not limited to such and other structures, including those described in U.S. Pat. Nos. 6,796,991, 7,422,571 and 8,052,646, each of which is incorporated herein by reference, may be utilized to join the opposed halves 52 a, 52 b with a weakened tear line defined therebetween. Eachnotch 54 is preferably aligned with one of the tear seams 48 of thesheath body 44 such that thenotches 54 and the tear seams 48 of thesheath body 44 are coplanar. - Referring to
FIG. 7 , the interior surface of thehub body 52 at the distal end defines aconical surface 56 configured to receive and fixedly connect thesheath body 44 proximal end. Thesheath hub 50 is fixedly connected to the proximal end of thesheath body 44 such as by an adhesive, ultrasonic bonding, insert molding or any other method known to those skilled in the art. The diameter of thisconical surface 56 may be manufactured to different sizes to allow thehub 50 to be used with larger or smallersize sheath bodies 44. Alternatively, theconical surface 56 may be manufactured to a standard size and a spacer ring (not shown) may be positioned between thesheath body 44 and theconical surface 56 to sealingly close the distal end of thehub body 52. - The interior surface of the
hub body 52 tapers outwardly from theconical surface 56 to anannular valve seat 60 which extends about the throughpassage 42. The proximal end 51 of thehub body 52 defines anannular wall 58 about thevalve seat 60. Thevalve seat 60 includes aplanar surface 62 extending about the throughpassage 42. Theplanar surface 62 is preferably continuous about the entire circumference of the throughpassage 42 such that it defines a continuous sealing surface. Anannular groove 63 is defined between theplanar surface 62 and theannular wall 58. A plurality ofalignment posts 64 extend proximally from within thegroove 63 and are configured properly align thevalve 80 received within thevalve seat 60 as described in more detail below. - A plurality of retaining
tabs 57 extend radially outward from the outer surface of thewall 58 for securing thecap members 100 as described below. Each retainingtab 57 preferably tapers outwardly moving from the proximal end to the distal end. - First and second diametrically opposed
winged tabs 70 extend from thesheath hub body 52 adjacent its proximal end 51. Thetabs 70 are circumferentially offset 90° relative to thenotches 54. In the illustrated embodiment, the first andsecond tabs 70 each include aperpendicular portion 72, perpendicular to the longitudinal axis L and anangled portion 74. Abrace member 76 may extend between eachperpendicular portion 72 and a distal portion of thehub body 52. In addition to supporting theperpendicular portions 72, thebraces 76 also help to concentrate the forces as thesheath hub 50 is torn away in a known manner. As shown inFIG. 6 , an angle α extends between the proximal surface of theperpendicular portion 72 and theangled portion 74 of each of thewings 42. The angle α ranges from approximately 90° to approximately 179°. Preferably, the angle α is between approximately 130° to approximately 140°; however, those skilled in the art will recognize that the angle α can have other ranges as well. Theangled portions 74 of thewinged tabs 70 include raisedridges 75 on their proximal and distal surfaces to aid in gripping thetabs 70. Alternatively, other raised features on thewinged tabs 70, such as bumps or a crosshatched pattern (not shown) may also assist the gripping thewinged tabs 70. - The
sheath body 44 is preferably constructed of high-density polyethylene, low-density polyethylene or polytetrafluoroethylene. Thesheath hub 50 is preferably constructed of high-density polyethylene or polypropylene. The dilator stem 26 is preferably constructed of high-density polyethylene, low-density polyethylene or polypropylene. Thedilator hub 22 is preferably constructed of high-density polyethylene or polypropylene. - Referring to
FIGS. 8-12 , anexemplary valve 80 will be described. Thevalve 80 has acylindrical body 82 with a diameter substantially equal to or slightly larger than the inside diameter of the hub bodyannular wall 58. While thevalve body 82 is shown as cylindrical, it may have any other shape which complements the shape of thevalve seat 60 andannular wall 58. Thebody 82 extends between aproximal surface 86 and adistal surface 94. A bisectingslot 83 extends into theproximal surface 86 across thebody 82 through the center thereof such that thebody 82 includes opposed body halves 82 a and 82 b. Theslot 83 terminates prior to thedistal surface 94 such that the body halves 82 a and 82 b are joined by a bridgingportion 84 along thedistal surface 94. The bridgingportion 84 has a reduced thickness t relative to the total thickness T of thevalve body 82. Preferably, the thickness t of the bridging portion is between approximately 0.002 to 0.006 inches and more preferably between approximately 0.003 to 0.004 inches. For relative comparison, the valve body thickness may be about 0.1 inches. With this configuration, the bridgingportion 84 retains the body halves 82 a, 82 b together prior to assembly and acts to seal the throughpassage 42, but remains easily split as an instrument is passed through thevalve 80 and easily separated when thesheath assembly 40 is split. - The
valve body 82 is preferably molded as a unitary component with thebridge portion 84 extending between thehalves 82 a, 82 b and theslot 83 preformed, however, thevalve body 82 may be otherwise formed. For example, the body halves 82 a, 82 b may be formed as separate components which are joined by thebridge portion 84 after formation. Alternatively, thebody 82 may be formed as a unitary structure and the slot is formed through a post molding process, for example, cutting, leaving just thebridge portion 84 extending between thehalves 82 a, 82 b. Preferably, thevalve 80 is constructed of silicone, however, those skilled in the art will recognize that thevalve 80 may be constructed out of any material that is sufficiently resilient to accommodate the objects inserted therethrough and return to a closed position. The material preferably has a durometer between 10 A to 40 A. The width G of theslot 83 is preferably minimal and is generally dictated by the method of manufacture. In the present embodiment, the width G is preferably about 0.005 inches, however, the width G may approach zero, as in simple separation of material, or may be larger than 0.005 inches. For example, if theslot 83 is formed through a post molding cutting operation, the width G may approach zero. Alternatively, thehalves 82 a, 82 b may be molded at an angle to one another with thebridge portion 84 extending therebween and the width G relatively large. As thehalves 82 a, 82 b are pivoted toward one another into a common plane, the width G may approach zero. - The
proximal surface 86 defines an outer annularplanar portion 87 that is substantially perpendicular to the longitudinal axis L when the valve is assembled within the sheath hub 50 (seeFIGS. 29 and 30 ). Anannular groove 88 is defined along theplanar portion 87 and is configured to receive a retainingridge 116 of thecap members 100 and also facilitates hinging of a center portion of thevalve body 82 as an item is passed through thevalve 80, as described in more detail below. A plurality of alignment holes 98 extend from thedistal surface 94 to theproximal surface 86 are defined circumferentially spaced about theplanar portion 87. While the alignment holes 98 are illustrated extending completely through thebody 82, such is not required. Alternatively, the alignment holes 98 may be formed as blind holes opening at thedistal surface 94. - The alignment holes 98 are configured to receive respective ones of the alignment posts 64 of the
valve seat 60. As seen inFIG. 10 , the alignment holes 98 are positioned in a non-symmetrical configuration. The alignment posts 64 are arranged in a corresponding configuration. As such, thevalve 80 can only be positioned in thesheath hub 50 in a proper orientation with theproximal surface 86 facing proximally and theslot 83 co-planar with thenotches 54. - Radially inward of the
planar portion 87, theproximal surface 86 defines aconical portion 89 which tapers to a central blind bore 90. Thebore 90 terminates in abottom surface 91 that is spaced from the bodydistal surface 94 such that thebore 90 does not pass completely through thevalve body 82. Thebore 90 may be formed with a narrowing taper from the entrance at theconical portion 89 to thebottom surface 91. Theconical portion 89 and thebore 90 serve to guide a guidewire (not shown), the dilatordistal tip 37, the catheter tip (not shown), or any other instrument as they are respectively passed through thevalve 80. Thebore 90 has a diameter d which is relatively small compared to the diameter D of thevalve body 82. The bore diameter d is generally related to the diameter of an intended guide wire and may be in the range of approximately 0.03 to 0.2 inches. For relative comparison, the diameter of the valve body D may be in the range of approximately 0.4 to 0.8 inches. As shown inFIG. 12 , theslot 83 may extend deeper than thebore 90 such that thebottom surface 91 is proximally spaced from the proximal surface of thebridge portion 84. - Optionally, a
pilot hole 92 extends through thebridge portion 84 and exits out the bodydistal surface 94. Thepilot hole 92 is preferably co-axial with thebore 90. Theguide hole 92 has a minimal diameter, for example, about or smaller than the diameter of a guidewire, and serves to provide a propagation point to split thebridge portion 84 and allow passage of an instrument through thevalve 80. In normal assembly as described below, thedilator 20 will be the first instrument passed through thevalve 80. The dilatordistal tip 37 will be guided to thepilot hole 92 by theconical surface 89 and thebore 90. As thedistal tip 37 reaches thepilot hole 92, it will pierce thebridge portion 84, with thebridge portion 84 splitting outwardly from thepilot hole 92. As the dilator stem 20 passes, the resiliency of thevalve 80 will cause thevalve 80 to seal against thestem 20 as it extends therethrough. Thevalve 80 will function in a similar manner as a catheter or other instrument is passed through thevalve 80. In each case, which ever instrument is passed through thevalve 80, thebridge 84 will slit only enough to pass the particular device and will effectively create a custom passage sized just to the device passing through. As thedilator 20 or other instrument is removed, the resiliency of thevalve 80 will cause thevalve 80 to substantially seal upon itself. - Referring to
FIGS. 9 and 12 , thedistal surface 94 of thevalve body 82 includes a pair of opposedarcuate grooves 96. Eachgroove 96 extends slightly less than 180° such that thegrooves 96 are separated by opposednon-grooved portions 95 of thedistal surface 94. Thenon-grooved portions 95 are preferably co-planar with theslot 83. Thegrooves 96 in conjunction with thenon-grooved portions 95 provide a resilient hinge effect for thevalve 80. As an instrument or the like is passed through thevalve 80, the central portion of thevalve body 82 will begin to deflect distally over an arcuate path as indicated by arrows A inFIG. 12 . Thegrooves 96 provide space for theproximate portions 97 of thedistal surface 94 to move during such deflection to allow easier passage, while thenon-grooved portions 95 provide some rigidity and assist in restoring the valve central portion to it original position as the instrument is removed. - Referring to
FIGS. 13-19 , anotherexemplary valve 80′ will be described. Thevalve 80′ is similar to the prior embodiment and has acylindrical body 82′ with a diameter substantially equal to or slightly larger than the inside diameter of the hub bodyannular wall 58. While thevalve body 82′ is shown as cylindrical, it may have any other shape which complements the shape of thevalve seat 60 andannular wall 58. Thebody 82′ extends between aproximal surface 86′ and adistal surface 94′. A bisectingslot 83′ extends into theproximal surface 86′ across thebody 82′ through the center thereof such that thebody 82′ includes opposed body halves 82 a′ and 82 b′. Theslot 83′ terminates prior to thedistal surface 94′ such that the body halves 82 a′ and 82 b′ are joined by a bridgingportion 84′ along thedistal surface 94′. The bridgingportion 84′ has a reduced thickness t1 and t2 relative to the total thickness T of theprimary valve body 82′, i.e. excluding the thickness of theconvex portion 99′. In the present embodiment, thebridge portion 84′ has varying thicknesses t1 and t2, with the central thickness t1 being larger than the thickness t2, however, thebridge portion 84′ may have a constant thickness, for example, equal to t2. Preferably, the thickness t2 of the outer bridging portion is between approximately 0.003 to 0.012 inches and more preferably between approximately 0.005 to 0.009 inches. Preferably, the thickness t1 of the central bridging portion is between approximately 0.003 to 0.012 inches and more preferably is between approximately 0.005 to 0.009 inches. For relative comparison, the valve body thickness may be about 0.1 inches. With this configuration, the bridgingportion 84′ retains the body halves 82 a′, 82 b′ together prior to assembly and acts to seal the throughpassage 42. - In the present embodiment, the
valve body 82′ is preferably molded as a unitary component and theslot 83′ is formed through a post molding process, for example, cutting, leaving just thebridge portion 84′ extending between thehalves 82 a′, 82 b′, however, thevalve body 82′ may be otherwise formed. For example, the body halves 82 a′, 82 b′ may be formed as separate components which are joined by thebridge portion 84′ after formation or thehalves 82 a′ and 82 b′ may be molded with a slot therebetween and just thebridge 84′ extending therebetween. Preferably, thevalve 80′ is constructed of silicone, however, those skilled in the art will recognize that thevalve 80′ may be constructed out of any material that is sufficiently resilient to accommodate the objects inserted therethrough and return to a closed position. The material preferably has a durometer between 10 A to 40 A. In the presently illustrated embodiment wherein theslot 83′ is created by post mold scoring, the width G of theslot 83′ approaches zero as the material of thehalves 82 a′, 82 b′ comes back together. - The
proximal surface 86′ defines an outer annularplanar portion 87′ that is substantially perpendicular to the longitudinal axis L when the valve is assembled within thesheath hub 50. Anannular groove 88′ is defined along theplanar portion 87′ and is configured to receive a retainingridge 116 of thecap members 100 and also facilitates hinging of a center portion of thevalve body 82′ as an item is passed through thevalve 80′. A plurality of alignment holes 98′ extend from thedistal surface 94′ to theproximal surface 86′ and are defined circumferentially spaced about theplanar portion 87′. While the alignment holes 98′ are illustrated extending completely through thebody 82′, such is not required. Alternatively, the alignment holes 98′ may be formed as blind holes opening at thedistal surface 94′. - The alignment holes 98′ are configured to receive respective ones of the alignment posts 64 of the
valve seat 60. In the present embodiment, the alignment holes 98′ are illustrated in a symmetrical configuration about one of the axis of the valve, however, the alignment holes 98′ may be positioned in a non-symmetrical configuration about all axis as in the previous embodiment. In either event, the alignment posts 64 are arranged in a corresponding configuration. - Radially inward of the
planar portion 87′, theproximal surface 86′ defines a conical,concave portion 89′ extending distally. As seen inFIG. 18 , thedistal surface 94′ defines aconvex area 99′ below the conical,concave portion 89′. Thebridge 84′ extends across theconvex area 99′. Theconcave portion 89′ on theproximal surface 86′ and theconvex area 99′ on thedistal surface 94′ allow the two sealing faces of the body halves 82 a′ and 82 b′ to come back together as the dilator or other medical device is removed. - The present embodiment does not include a bore as in the previous embodiment, but instead includes a
bisecting slit 150 that extends through thevalve body 82′ from theproximal surface 86′ and out thedistal surface 94′. The bisecting slit 150 is not co-planar with theslot 83′ but instead is at an angle Ω, seeFIG. 15 , relative to theslot 83′. The angle Ω is preferably in a range of approximately 45° to 135° and is most preferably equal to about 90°. In this manner, the sealing function of theslit 150 and the splitting function of theslot 83′ are separated. While asingle slit 150 is illustrated, multiple splits at different angles relative to theslot 83′ may be provided. - Referring to
FIGS. 18 and 19 , it is preferable that theslit 150 is at an angle δ relative to the longitudinal axis L. The angle δ is preferably in a range of approximately 20° to 70° and is most preferably equal to about 45°. Preferably theslit 150 is positioned such that theproximal opening 151 of theslit 150 is on one side of the axis L while thedistal exit 153 is on the opposite side of the axis L. - In normal assembly, the
dilator 20 will be the first instrument passed through thevalve 80′. The dilatordistal tip 37 will enter theslit 150 and will thereby bypass thebridge portion 84′, without necessitating splitting of thebridge portion 84. As the dilator stem 20 passes, the resiliency of thevalve 80′ will cause thevalve 80′ to seal against thestem 20 as it extends therethrough. Thevalve 80′ will function in a similar manner as a catheter or other instrument is passed through thevalve 80′. In each case, which ever instrument is passed through thevalve 80′, theslit 150 will open only enough to pass the particular device and will effectively create a general seal about the device passing through. As thedilator 20 or other instrument is removed, the resiliency of thevalve 80′ will cause thevalve 80′ to substantially seal upon itself, with the convex configuration of theconical portion 89′ assisting in such sealing. - Referring to
FIGS. 20-24 , anotherexemplary valve 80″ will be described. Thevalve 80″ is similar to the prior embodiments and has acylindrical body 82″ with a diameter substantially equal to or slightly larger than the inside diameter of the hub bodyannular wall 58. While thevalve body 82″ is shown as cylindrical, it may have any other shape which complements the shape of thevalve seat 60 andannular wall 58. Thebody 82″ extends between aproximal surface 86″ and adistal surface 94″. A bisectingslot 83″ extends into theproximal surface 86″ across thebody 82″ through the center thereof such that thebody 82″ includes opposed body halves 82 a″ and 82 b″. Theslot 83″ terminates prior to thedistal surface 94″ such that the body halves 82 a″ and 82 b″ are joined by a bridgingportion 84″ along thedistal surface 94″. The bridgingportion 84″ has a reduced thickness t relative to the total thickness T of thevalve body 82″. Preferably, the thickness t of the bridging portion is between approximately 0.002 to 0.006 inches and more preferably between approximately 0.003 to 0.004 inches. For relative comparison, the valve body thickness may be about 0.1 inches. With this configuration, the bridgingportion 84″ retains the body halves 82 a″, 82 b″ together prior to assembly and acts to seal the throughpassage 42, but remains easily split as an instrument is passed through thevalve 80″ and easily separated when thesheath assembly 40 is split. - The
valve body 82″ is preferably molded as a unitary component with thebridge portion 84″ extending between thehalves 82 a″, 82 b″ and theslot 83″ preformed, however, thevalve body 82″ may be otherwise formed. For example, the body halves 82 a″, 82 b″ may be formed as separate components which are joined by thebridge portion 84″ after formation. Alternatively, thebody 82″ may be formed as a unitary structure and the slot is formed through a post molding process, for example, cutting, leaving just thebridge portion 84″ extending between thehalves 82 a″, 82 b″. Preferably, thevalve 80″ is constructed of silicone, however, those skilled in the art will recognize that thevalve 80″ may be constructed out of any material that is sufficiently resilient to accommodate the objects inserted therethrough and return to a closed position. The material preferably has a durometer between 10 A to 40 A. The width G of theslot 83″ is preferably minimal and is generally dictated by the method of manufacture. In the present embodiment, the width G is preferably about 0.005 inches, however, the width G may approach zero, as explained above, or may be larger than 0.005 inches. - The
proximal surface 86″ defines an outer annularplanar portion 87″ that is substantially perpendicular to the longitudinal axis L when the valve is assembled within thesheath hub 50. Anannular groove 88″ is defined along theplanar portion 87″ and is configured to receive a retainingridge 116 of thecap members 100 and also facilitates hinging of a center portion of thevalve body 82″ as an item is passed through thevalve 80″. A plurality of alignment holes 98″ extend from thedistal surface 94″ to theproximal surface 86″ are defined circumferentially spaced about theplanar portion 87″. While the alignment holes 98″ are illustrated extending completely through thebody 82″, such is not required. Alternatively, the alignment holes 98″ may be formed as blind holes opening at thedistal surface 94″. - The alignment holes 98″ are configured to receive respective ones of the alignment posts 64 of the
valve seat 60. In the present embodiment, the alignment holes 98″ are illustrated in a symmetrical configuration about one of the axis of the valve, however, the alignment holes 98″ may be positioned in a non-symmetrical configuration about all axis as in the previous embodiment. In either event, the alignment posts 64 are arranged in a corresponding configuration. - Radially inward of the
planar portion 87″, theproximal surface 86″ defines a conical,convex portion 89″ extending proximally. As seen inFIG. 22 , thedistal surface 94″ defines aconcave area 99″ below the conical,convex portion 89″. Thebridge 84″ extends across theconcave area 99″. Theconvex portion 89″ on theproximal surface 86″ and theconcave area 99″ on thedistal surface 94″ allow the two sealing faces of the body halves 82 a″ and 82 b″ to come back together as the dilator or other medical device is removed. - The present embodiment does not include a bore as in the first embodiment, but optionally may include a
pilot hole 92″ co-axial with thevalve body 82″. In normal assembly, thedilator 20 will be the first instrument passed through thevalve 80″. The dilatordistal tip 37 will enter theslot 83″ and will pierce thebridge portion 84″, with thebridge portion 84 splitting outwardly from thepilot hole 92″. As the dilator stem 20 passes, the resiliency of thevalve 80″ will cause thevalve 80″ to seal against thestem 20 as it extends therethrough. Thevalve 80″ will function in a similar manner as a catheter or other instrument is passed through thevalve 80″. In each case, which ever instrument is passed through thevalve 80″, thebridge 84″ will slit only enough to pass the particular device and will effectively create a custom passage sized just to the device passing through. As thedilator 20 or other instrument is removed, the resiliency of thevalve 80″ will cause thevalve 80″ to substantially seal upon itself, with the concave configuration of theconical portion 89″ assisting in such sealing. - Referring to
FIGS. 22-24 , thedistal surface 94″ of thevalve body 82″ includes a pair of opposedarcuate grooves 96″. Eachgroove 96″ extends slightly less than 180° such that thegrooves 96″ are separated by opposednon-grooved portions 95″ of thedistal surface 94″. Thenon-grooved portions 95″ are preferably co-planar with theslot 83″. Thegrooves 96″ in conjunction with thenon-grooved portions 95″ provide a resilient hinge effect for thevalve 80″. As an instrument or the like is passed through thevalve 80″, the central portion of thevalve body 82″ will begin to deflect distally over an arcuate path as indicated by arrows A inFIG. 22 . Thegrooves 96″ provide space for theproximate portions 97″ of thedistal surface 94″ to move during such deflection to allow easier passage, while thenon-grooved portions 95″ provide some rigidity and assist in restoring the valve central portion to it original position as the instrument is removed. - Referring to
FIGS. 25 and 26 , anexemplary cap member 100 will be described. Thesheath assembly 40 preferably uses twocap members 100 which are identical, however, paired cap members having different but complimentary configurations may be utilized. Eachcap member 100 of the exemplary embodiment includes asemi-circular platform 102 with a dependingsemi-circular wall 104 along its outer circumference. The inside diameter of thewall 104 is approximately equal to our slightly larger than the outside diameter of thesheath hub wall 58. A pair of retainingopenings 106 are defined through thecircular wall 104, with each retainingopening 106 positioned and configured to receive and retain arespective retaining tab 57 of thesheath hub 50. While twoopenings 106 and twocorresponding tabs 57 are described herein, more or fewer connections may be utilized. A portion of thewall 104 opposite theflat side 101 of theplatform 102 defines arecess 105 which is configured to align with and receive a portion of a respectivewinged tab 70 when thecap member 100 is connected to thehub body 52. Each end of thesemi-circular wall 104 has a returningwall portion 108 which extends radially inward and is configured to be received in arespective notch 54 of thehub body 52 when thecap member 100 is secured to thehub body 52. Asemi-circular retaining ridge 116 depends from the distal surface of theplatform 102 and is co-axial with theplatform 102. The function of theridge 116 will be described below. - A
semi-circular opening 103 is defined through and co-axially with theplatform 102 such that the open side of theopening 103 is along theflat side 101 of the platform. A proximally extendingsemi-circular wall 110 extends from the proximal side of theplatform 102 about theopening 103, and defines anopen passage 111. In the illustrated embodiment, theplatform 101 extends radially inward of thewall 110 such that a diameter of theopen passage 111 is slightly larger than theopening 103. However, theplatform 101 may terminate at thewall 110 such that theopen passage 111 and theopening 103 have substantially the same diameter. The outside surface of thewall 110 has a diameter WD. The diameter WD is approximately equal to or slightly smaller than the distance E between theengagement portions 34 of thedilator hub 22. - As seen in
FIGS. 27-29 , when thecap members 100 are secured to thehub body 52 opposite one another, the twosemi-circular openings 103 and the twosemi-circular walls 110 define a substantially circular opening which forms a part of the throughpassage 42. The diameter of theopening 103 and theopen passage 111 may be sized to correspond to a particular sheath or dilator size or a group of sizes within a given range. The ends of thewall 110 preferably havenotches 112 on the proximal surface which when assembled define astop receptacle 120 as will be described below. - The portion of the
wall 110 opposite theflat side 101 of theplatform 102 defines a radially outwardly extendingproximal flange 114 which is longitudinally spaced from theplatform 102 and extends beyond alongitudinal portion 117 of thewall 110 such that a receivingopening 115 is defined between theflange 114 and theplatform 102. The distance from theflat side 101 of theplatform 102 to thelongitudinal portion 117 of thewall 110 is approximately one-half the diameter WD and the distance from theflat side 101 to the radial edge of theflange 114 is approximately one-half the distance F that thedilator hub extensions 33 are spaced. As such, when thecap members 100 are connected to thehub body 52, thewall 110 andportions 117 will define a diameter equal to WD which is approximately equal to or slightly smaller than the distance E between theengagement portions 34 of thedilator hub 22 and theflanges 114 will define a distance approximately equal to or slightly larger than the distance F that thedilator hub extensions 33 are spaced. Thewall 110 andflanges 114 thereby define the lockingportion 129 of thesheath assembly 40. - Having described the components of the
sheath hub 50, assembly thereof will be described with reference to FIGS. 2 and 27-30. While assembly is described with reference to thevalve 80, it is appreciated that thevalve 80′ may be utilized in the same manner. It is noted that thesheath body 44 is not illustrated inFIGS. 27-30 , but typically thesheath body 44 will be attached to thehub body 52 prior to final assembly of thesheath hub 50. Thevalve 80 is positioned on thevalve seat 60 within thehub body wall 58. As thevalve 80 is positioned, the alignment posts 64 are received within the alignment openings 98 (seeFIG. 30 ) and thesheath hub wall 58 radially compresses thevalve body 82 such that the width of theslot 83 is reduced. As explained above, theposts 64 andopenings 98 are arranged such that thevalve 80 can only be properly positioned in the desired orientation, i.e. with theproximal surface 86 facing proximally and theslot 83 aligned with the space between the twocap members 100 and with thehub notches 54. With thevalve 80 positioned on theseat 60, thedistal surface 94 of thevalve body 82 seats upon the seatplanar surface 62. Thedistal surface 94 is spaced from the surface ofgroove 63. This space allows for compression of thevalve body 82 when thecap members 100 are secured, thereby enhancing the seal between thedistal surface 94 and theplanar surface 62. Thedistal grooves 96 are positioned radially inward from theplanar surface 62, aligned with the throughpassage 42, to facilitate hinging of the central portion of thevalve body 82. - Once the
valve 80 is positioned, eachcap member 100 is connected to a respective valve body halve 52 a, 52 b. Thecap member 100 is snapped onto thevalve body 52, withrespective retaining tabs 57 received in the retainingopenings 106 as thewall 104 extends about thehub wall 58. Theplatforms 102 preferably slightly compress thevalve body 82 when thecap members 100 are connected. Eachcap member 100 is preferably separably connectable such that interconnection between the twocap members 100 is not required to maintain thecap members 100 in position. Thecap members 100 are separated from one another by a slot which aligns with thenotches 54. With thecap members 100 in place, theopenings portion 89 and bore 90 of thevalve 80. The retainingridges 116 are received in thecorresponding grooves 88 on theproximal surface 86 of thevalve body 82. Theridges 116 retain the out perimeter of thevalve body 82 secure and enhance the seal on seatplanar surface 62 while allowing the central portion of thevalve body 82, radially inward of thegrooves 88, to hingedly flex during insertion of an instrument. As shown inFIG. 29 , theopposed notches 112 ofadjacent cap members 100 define astop receptacle 120. - With the
sheath hub 50 assembled, thedilator 20 may be inserted therein and locked in place by engagement of the lockingportions FIGS. 31-33 . Referring toFIG. 31 , the dilator stem 36 is passed through theopening 111 defined by thecap members 100 and then through the valve 80 (not shown inFIG. 31 ) and into thesheath body 44. During insertion, thedilator 20 is oriented such that thedilator hub platform 32 is transverse to the direction of theflanges 114 of thecap members 100. With this orientation, the dilator stem 36 may be fully inserted with thecap member walls 110 received between theengagement portions 34 of thedilator hub 22 as shown inFIG. 32 . Theengagement portions 34 contact thecap member platforms 102 upon full insertion. - After the
dilator 20 has been fully inserted relative to thesheath assembly 40, thedilator hub 22 is rotated, as indicated by arrow B inFIG. 33 , to the locking position. As thedilator hub 22 is rotated, thecap member flanges 114 are received in the lockinggrooves 45 of thedilator hub 22 and theengagement portions 34 are received in the receivingopenings 115. The capmember wall portions 117 are each tapered at one end to facilitate passage of theengagement portions 34 into the receivingopenings 115 while the opposite ends of thewall portions 117 define astop 121 which prevent over rotation of thedilator hub 22 relative to thesheath hub 50. Rotation from the initial fully inserted position to the locked position illustrated inFIG. 33 is preferably over approximately 90°. As thedilator hub 22 reaches the locked position, thestop members 25 are received in thestop receptacle 120 such that a disengaging rotation force is necessary to unlock thedilator hub 22 relative to thesheath hub 50. Engagement of the lockingportions dilator 20 and thesheath assembly 40. The dilator andsheath assembly 10 is now ready for use as illustrated inFIG. 1 . - These and other advantages of the present invention will be apparent to those skilled in the art from the foregoing specification. Accordingly, it will be recognized by those skilled in the art that changes or modifications may be made to the above-described embodiments without departing from the broad inventive concepts of the invention. It should therefore be understood that this invention is not limited to the particular embodiments described herein, but is intended to include all changes and modifications that are within the scope and spirit of the invention as defined in the claims.
Claims (20)
Priority Applications (15)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/832,294 US20130310765A1 (en) | 2012-05-17 | 2013-03-15 | Valve for dilator and sheath assembly |
MX2014014029A MX2014014029A (en) | 2012-05-17 | 2013-05-15 | Valve for dilator and sheath assembly. |
AU2013262916A AU2013262916B2 (en) | 2012-05-17 | 2013-05-15 | Valve for dilator and sheath assembly |
PCT/US2013/041109 WO2013173438A1 (en) | 2012-05-17 | 2013-05-15 | Valve for dilator and sheath assembly |
EP18000792.4A EP3446739A1 (en) | 2012-05-17 | 2013-05-15 | Valve for dilator and sheath assembly |
ES13733097T ES2705012T3 (en) | 2012-05-17 | 2013-05-15 | Valve for dilator and sheath assembly |
CA2873988A CA2873988C (en) | 2012-05-17 | 2013-05-15 | Valve for dilator and sheath assembly |
EP13733097.3A EP2849833B1 (en) | 2012-05-17 | 2013-05-15 | Valve for dilator and sheath assembly |
PL13733097T PL2849833T3 (en) | 2012-05-17 | 2013-05-15 | Valve for dilator and sheath assembly |
MX2020011003A MX2020011003A (en) | 2012-05-17 | 2014-11-18 | Valve for dilator and sheath assembly. |
US15/718,722 US11565101B2 (en) | 2012-05-17 | 2017-09-28 | Valve for dilator and sheath assembly |
US17/072,864 US11850393B2 (en) | 2012-05-17 | 2020-10-16 | Valve for dilator and sheath assembly |
US17/072,421 US11850392B2 (en) | 2012-05-17 | 2020-10-16 | Valve for dilator and sheath assembly |
US17/659,237 US20220233838A1 (en) | 2012-05-17 | 2022-04-14 | Valve for dilator and sheath assembly |
US18/147,436 US20230181891A1 (en) | 2012-05-17 | 2022-12-28 | Valve for dilator and sheath assembly |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US201261648132P | 2012-05-17 | 2012-05-17 | |
US201261725509P | 2012-11-13 | 2012-11-13 | |
US13/832,294 US20130310765A1 (en) | 2012-05-17 | 2013-03-15 | Valve for dilator and sheath assembly |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US15/718,722 Continuation US11565101B2 (en) | 2012-05-17 | 2017-09-28 | Valve for dilator and sheath assembly |
Publications (1)
Publication Number | Publication Date |
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US20130310765A1 true US20130310765A1 (en) | 2013-11-21 |
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US13/832,294 Abandoned US20130310765A1 (en) | 2012-05-17 | 2013-03-15 | Valve for dilator and sheath assembly |
US15/718,722 Active US11565101B2 (en) | 2012-05-17 | 2017-09-28 | Valve for dilator and sheath assembly |
US17/072,421 Active 2034-04-18 US11850392B2 (en) | 2012-05-17 | 2020-10-16 | Valve for dilator and sheath assembly |
US17/072,864 Active 2034-05-01 US11850393B2 (en) | 2012-05-17 | 2020-10-16 | Valve for dilator and sheath assembly |
US17/659,237 Pending US20220233838A1 (en) | 2012-05-17 | 2022-04-14 | Valve for dilator and sheath assembly |
US18/147,436 Pending US20230181891A1 (en) | 2012-05-17 | 2022-12-28 | Valve for dilator and sheath assembly |
Family Applications After (5)
Application Number | Title | Priority Date | Filing Date |
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US15/718,722 Active US11565101B2 (en) | 2012-05-17 | 2017-09-28 | Valve for dilator and sheath assembly |
US17/072,421 Active 2034-04-18 US11850392B2 (en) | 2012-05-17 | 2020-10-16 | Valve for dilator and sheath assembly |
US17/072,864 Active 2034-05-01 US11850393B2 (en) | 2012-05-17 | 2020-10-16 | Valve for dilator and sheath assembly |
US17/659,237 Pending US20220233838A1 (en) | 2012-05-17 | 2022-04-14 | Valve for dilator and sheath assembly |
US18/147,436 Pending US20230181891A1 (en) | 2012-05-17 | 2022-12-28 | Valve for dilator and sheath assembly |
Country Status (8)
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US (6) | US20130310765A1 (en) |
EP (2) | EP2849833B1 (en) |
AU (1) | AU2013262916B2 (en) |
CA (1) | CA2873988C (en) |
ES (1) | ES2705012T3 (en) |
MX (2) | MX2014014029A (en) |
PL (1) | PL2849833T3 (en) |
WO (1) | WO2013173438A1 (en) |
Cited By (11)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2015085123A1 (en) * | 2013-12-05 | 2015-06-11 | Cardiac Pacemakers, Inc. | Cuttable catheter hub with integrated hemostasis valve |
WO2017147103A1 (en) * | 2016-02-22 | 2017-08-31 | Abiomed, Inc. | Introducer sheath having a multi-layer hub |
US20180126142A1 (en) * | 2016-11-09 | 2018-05-10 | Boston Scientific Limited | Hemostasis valve design for introducer sheath |
US20180256849A1 (en) * | 2013-11-21 | 2018-09-13 | Jet Medical, Inc. | System for facilitating intranasal guidance |
WO2019090351A3 (en) * | 2017-11-06 | 2019-06-13 | Abiomed, Inc. | Peel away hemostasis valve |
US10557552B2 (en) | 2016-11-21 | 2020-02-11 | Cardiac Pacemakers, Inc. | Trough seal |
US10709875B2 (en) | 2015-01-07 | 2020-07-14 | Abiomed Europe Gmbh | Introducer sheath |
CN112206397A (en) * | 2016-09-12 | 2021-01-12 | C·R·巴德股份有限公司 | Blood control for catheter insertion devices |
WO2022265961A1 (en) * | 2021-06-17 | 2022-12-22 | Edwards Lifesciences Corporation | Removable sheath assembly |
WO2023055703A1 (en) * | 2021-09-28 | 2023-04-06 | Medical Components, Inc. | Introducer sheath assembly and method of making the same |
CN117257423A (en) * | 2023-11-23 | 2023-12-22 | 安徽通灵仿生科技有限公司 | Anti-countercurrent tearable sheath tube |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20130310765A1 (en) * | 2012-05-17 | 2013-11-21 | Medical Components, Inc. | Valve for dilator and sheath assembly |
CN211884905U (en) | 2019-08-22 | 2020-11-10 | 贝克顿·迪金森公司 | Balloon dilatation catheter and balloon thereof |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5006113A (en) * | 1990-02-08 | 1991-04-09 | Cook Incorporated | Hemostasis cannula |
US20060030817A1 (en) * | 2004-08-05 | 2006-02-09 | Kraus Mark C | Valved introducer assembly and method therefor |
US20090143739A1 (en) * | 2007-09-18 | 2009-06-04 | Medical Components, Inc | Tearaway sheath assembly with split hemostasis valve |
US20100100044A1 (en) * | 2008-10-22 | 2010-04-22 | Greatbatch Medical | Splittable Valved Introducer Apparatus |
US20100101069A1 (en) * | 2004-04-30 | 2010-04-29 | C.R. Bard, Inc. | Valved sheath introducer for venous cannulation |
US20100241083A1 (en) * | 2007-06-22 | 2010-09-23 | Medical Components, Inc. | Hub for tearaway sheath assembly |
Family Cites Families (17)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4772266A (en) | 1987-05-04 | 1988-09-20 | Catheter Technology Corp. | Catheter dilator/sheath assembly and method |
JPH04170966A (en) * | 1990-11-01 | 1992-06-18 | Nippon Sherwood Kk | Valvular body for catheter introducer blood stop valve |
US5199948A (en) * | 1991-05-02 | 1993-04-06 | Mcgaw, Inc. | Needleless valve |
US5098392A (en) | 1991-06-28 | 1992-03-24 | Fleischhacker John J | Locking dilator for peel away introducer sheath |
US5273546A (en) * | 1991-08-01 | 1993-12-28 | Medtronic, Inc. | Hemostasis valve |
US8753317B2 (en) * | 1992-05-06 | 2014-06-17 | Cook Medical Technologies Llc | Hemostasis cannula |
EP0631793A1 (en) * | 1993-06-30 | 1995-01-04 | Cook Incorporated | Splittable hemostatic valve and method of use with a splittable introducer sheath |
US5885217A (en) | 1995-01-20 | 1999-03-23 | Tyco Group S.A.R.L. | Catheter introducer |
JP3941022B2 (en) * | 1997-10-31 | 2007-07-04 | 日本シャーウッド株式会社 | Catheter introducer |
US7422571B2 (en) | 2002-08-29 | 2008-09-09 | Medical Components, Inc. | Releasably locking dilator and sheath assembly |
US6796991B2 (en) | 2002-08-29 | 2004-09-28 | Medical Components, Inc. | Releasably locking dilator and sheath assembly |
US20040267202A1 (en) * | 2003-06-26 | 2004-12-30 | Potter Daniel J. | Tearable hemostasis valve and splittable sheath |
US7985232B2 (en) * | 2003-07-08 | 2011-07-26 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Detachable hemostasis valve and splittable sheath assembly |
US6951295B1 (en) * | 2005-01-18 | 2005-10-04 | Seaquist Closures Foreign, Inc. | Flow control element and dispensing structure incorporating same |
WO2009041523A1 (en) * | 2007-09-27 | 2009-04-02 | Terumo Kabushiki Kaisha | Valve element and medical instrument |
US8974420B2 (en) * | 2011-09-16 | 2015-03-10 | Oscor Inc. | Large french size hemostatic valve configuration |
US20130310765A1 (en) * | 2012-05-17 | 2013-11-21 | Medical Components, Inc. | Valve for dilator and sheath assembly |
-
2013
- 2013-03-15 US US13/832,294 patent/US20130310765A1/en not_active Abandoned
- 2013-05-15 WO PCT/US2013/041109 patent/WO2013173438A1/en active Application Filing
- 2013-05-15 ES ES13733097T patent/ES2705012T3/en active Active
- 2013-05-15 PL PL13733097T patent/PL2849833T3/en unknown
- 2013-05-15 EP EP13733097.3A patent/EP2849833B1/en active Active
- 2013-05-15 CA CA2873988A patent/CA2873988C/en active Active
- 2013-05-15 MX MX2014014029A patent/MX2014014029A/en active IP Right Grant
- 2013-05-15 AU AU2013262916A patent/AU2013262916B2/en active Active
- 2013-05-15 EP EP18000792.4A patent/EP3446739A1/en not_active Withdrawn
-
2014
- 2014-11-18 MX MX2020011003A patent/MX2020011003A/en unknown
-
2017
- 2017-09-28 US US15/718,722 patent/US11565101B2/en active Active
-
2020
- 2020-10-16 US US17/072,421 patent/US11850392B2/en active Active
- 2020-10-16 US US17/072,864 patent/US11850393B2/en active Active
-
2022
- 2022-04-14 US US17/659,237 patent/US20220233838A1/en active Pending
- 2022-12-28 US US18/147,436 patent/US20230181891A1/en active Pending
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5006113A (en) * | 1990-02-08 | 1991-04-09 | Cook Incorporated | Hemostasis cannula |
US20100101069A1 (en) * | 2004-04-30 | 2010-04-29 | C.R. Bard, Inc. | Valved sheath introducer for venous cannulation |
US20060030817A1 (en) * | 2004-08-05 | 2006-02-09 | Kraus Mark C | Valved introducer assembly and method therefor |
US20100241083A1 (en) * | 2007-06-22 | 2010-09-23 | Medical Components, Inc. | Hub for tearaway sheath assembly |
US20090143739A1 (en) * | 2007-09-18 | 2009-06-04 | Medical Components, Inc | Tearaway sheath assembly with split hemostasis valve |
US20100100044A1 (en) * | 2008-10-22 | 2010-04-22 | Greatbatch Medical | Splittable Valved Introducer Apparatus |
Cited By (25)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10518065B2 (en) | 2013-11-21 | 2019-12-31 | Jet Medical Inc. | Method for facilitating intranasal guidance |
US20180256849A1 (en) * | 2013-11-21 | 2018-09-13 | Jet Medical, Inc. | System for facilitating intranasal guidance |
US9974938B2 (en) | 2013-12-05 | 2018-05-22 | Cardiac Pacemakers, Inc. | Cuttable catheter hub with integrated hemostasis valve |
CN105792881A (en) * | 2013-12-05 | 2016-07-20 | 心脏起搏器股份公司 | Cuttable catheter hub with integrated hemostasis valve |
JP2016538924A (en) * | 2013-12-05 | 2016-12-15 | カーディアック ペースメイカーズ, インコーポレイテッド | Cutable catheter hub with integrated hemostasis valve |
WO2015085123A1 (en) * | 2013-12-05 | 2015-06-11 | Cardiac Pacemakers, Inc. | Cuttable catheter hub with integrated hemostasis valve |
US11865275B2 (en) | 2015-01-07 | 2024-01-09 | Abiomed Europe Gmbh | Introducer sheath |
US10709875B2 (en) | 2015-01-07 | 2020-07-14 | Abiomed Europe Gmbh | Introducer sheath |
US11369413B2 (en) | 2016-02-22 | 2022-06-28 | Abiomed, Inc. | Introducer sheath having a multi-layer hub |
WO2017147103A1 (en) * | 2016-02-22 | 2017-08-31 | Abiomed, Inc. | Introducer sheath having a multi-layer hub |
US10709476B2 (en) | 2016-02-22 | 2020-07-14 | Abiomed, Inc. | Introducer sheath having a multi-layer hub |
CN112206397A (en) * | 2016-09-12 | 2021-01-12 | C·R·巴德股份有限公司 | Blood control for catheter insertion devices |
WO2018089390A1 (en) * | 2016-11-09 | 2018-05-17 | Boston Scientific Scimed, Inc | Hemostasis valve design for introducer sheath |
CN110430912A (en) * | 2016-11-09 | 2019-11-08 | 波士顿科学有限公司 | Haemostatic valve for guide sheath designs |
JP2019534133A (en) * | 2016-11-09 | 2019-11-28 | ボストン サイエンティフィック リミテッド | Hemostatic valve structure for introducer sheath |
US20180126142A1 (en) * | 2016-11-09 | 2018-05-10 | Boston Scientific Limited | Hemostasis valve design for introducer sheath |
US10835729B2 (en) * | 2016-11-09 | 2020-11-17 | Boston Scientific Limited | Hemostasis valve design for introducer sheath |
US20210023358A1 (en) * | 2016-11-09 | 2021-01-28 | Boston Scientific Limited | Hemostasis valve design for introducer sheath |
US11779743B2 (en) * | 2016-11-09 | 2023-10-10 | Boston Scientific Limited | Hemostasis valve design for introducer sheath |
US10557552B2 (en) | 2016-11-21 | 2020-02-11 | Cardiac Pacemakers, Inc. | Trough seal |
US11045634B2 (en) | 2017-11-06 | 2021-06-29 | Abiomed, Inc. | Peel away hemostasis valve |
WO2019090351A3 (en) * | 2017-11-06 | 2019-06-13 | Abiomed, Inc. | Peel away hemostasis valve |
WO2022265961A1 (en) * | 2021-06-17 | 2022-12-22 | Edwards Lifesciences Corporation | Removable sheath assembly |
WO2023055703A1 (en) * | 2021-09-28 | 2023-04-06 | Medical Components, Inc. | Introducer sheath assembly and method of making the same |
CN117257423A (en) * | 2023-11-23 | 2023-12-22 | 安徽通灵仿生科技有限公司 | Anti-countercurrent tearable sheath tube |
Also Published As
Publication number | Publication date |
---|---|
US20210031024A1 (en) | 2021-02-04 |
WO2013173438A1 (en) | 2013-11-21 |
EP2849833A1 (en) | 2015-03-25 |
US11565101B2 (en) | 2023-01-31 |
US11850393B2 (en) | 2023-12-26 |
US20210031023A1 (en) | 2021-02-04 |
MX2014014029A (en) | 2015-08-14 |
CA2873988C (en) | 2019-02-19 |
AU2013262916B2 (en) | 2016-12-22 |
US20180015277A1 (en) | 2018-01-18 |
EP3446739A1 (en) | 2019-02-27 |
EP2849833B1 (en) | 2018-10-10 |
AU2013262916A1 (en) | 2014-12-11 |
ES2705012T3 (en) | 2019-03-21 |
PL2849833T3 (en) | 2019-05-31 |
CA2873988A1 (en) | 2013-11-21 |
US20220233838A1 (en) | 2022-07-28 |
US20230181891A1 (en) | 2023-06-15 |
MX2020011003A (en) | 2020-11-09 |
US11850392B2 (en) | 2023-12-26 |
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