WO2016123503A1 - Reconstrainable stent delivery system with a slider and knob for actuation and method - Google Patents

Reconstrainable stent delivery system with a slider and knob for actuation and method

Info

Publication number
WO2016123503A1
WO2016123503A1 PCT/US2016/015696 US2016015696W WO2016123503A1 WO 2016123503 A1 WO2016123503 A1 WO 2016123503A1 US 2016015696 W US2016015696 W US 2016015696W WO 2016123503 A1 WO2016123503 A1 WO 2016123503A1
Authority
WO
Grant status
Application
Patent type
Prior art keywords
member
tubular
stent
elongated
housing
Prior art date
Application number
PCT/US2016/015696
Other languages
French (fr)
Inventor
Thomas J. MOCK
Carolyn G. RICE
William D. Kelly
Eric Bielefeld
Adwait KUMAR
Original Assignee
Flexible Stent Solutions, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9534Instruments specially adapted for placement or removal of stents or stent-grafts for repositioning of stents

Abstract

Devices, systems and methods are described and involve deploying and reconstraining a stent. An intravascular device with first and second elongated tubular members capable of axial motion relative to a housing having an annular lock configured to secure in first state and release the intraluminal device in second state, the intraluminal device being coaxially disposed over the second elongated tubular member proximal of a distal stop. Actuators on the housing may withdraw or advance the first and second tubular members. The first tubular member is withdrawn to deploy the stent and is advanced to reconstrain the s tent. The second tubular member is withdrawn to engage the distal stop with the annular lock prior to reconstraining. The device may have a directional control that is engaged by an actuator to allow only proximal motion of the first elongated tubular member relative to the housing and allows only distal motion of the first elongated tubular member when disengaged.

Description

SLIDER AND KN OB FOR ACTUATION AND METHOD

Thomas MOCK

Carolyn RICE

William KELLY

Eric BIELEFELD

Adwait KUMAR

issigsiee: Flexible Stentine Solutions, Inc.

Large

Atty. Docket No,: FFS5014USPCT CROSS REFERENCE TO RELATED APPLICATIONS

[001 ] This application claims priority under 35 USC §119 or the Paris Convention from U.S. Provisional Patent Application 62/110,527 (Attorney Docket No.

FSS5013USPSP) filed Januar ' 31 , 2015 and U.S. Provisional Patent Apphcatio No, 62/197,515 (Attorney Docket No, FSS5014USPSP) filed July 27, 2015, the entire contents of which are incorporated herein by reference as if set forth in full herein.

FIELD OF THE PRESENT DISCLOSURE

1002] This disclosure relates to the field of medical devices, and more particularly medical devices or delivery systems for and methods of control! ably deploying stents and reconstraining partially deployed stents. In some applications, the disclosure relates to systems for delivering a self-expandable intraluminal graft ("stent") for use within a body passageway or duct which are particularly useful for repairing blood vessels narrowed or occluded by disease,

BACKGROUND

[003] Transluminal prostheses have been widely used in the medical arts for implantation in blood vessels, biliary ducts, or other similar lumens of the living body. These prostheses are commonly known as stents and are used to maintain, open, or dilate tubular structures. An example of a commonly used stent is given in U.S. Patent 4,733,665 filed by Palmaz on November 7, 1985, which is hereby incorporated in its entirety herein by reference. Such stents are often referred to as balloon expandable stents. Typically the stent is made from a solid tube of stainless steel . Thereafter, a series of cuts are made in the wall of the stent. The stent has a first smaller diameter which permits the stent to be delivered through the human vasculature by being crimped onto a balloon catheter. The stent also has a second, expanded diameter, upon the application, by the balloon catheter, from the interior of the tubular shaped member of a radially, outwardly extending force.

[0041 However, such stents are often impractical for use in some vessels such as the carotid artery or the superficial femoral artery. The carotid artery is easily accessible from the exterior of the human body, and is often visible by looking at one's neck. A patient having a balloon expandable stent made from stainless steel, or the like, placed in his or her carotid artery might be susceptible to severe injury through day-to-day activity. A sufficient force placed on the patient's neck, such as by falling, could cause the stent to collapse resulting in injury to the patient. In order to prevent this and to address other shortcomings of balloon expandable stents, self-expanding stents were developed. Self-expanding stents act like springs and will recover to their expanded or implanted configuration after being crushed.

[005] One type of self-expanding stent is disclosed in U.S. Patent 4,665,771, which stent has a radially and axialiy flexible, elastic tubular body with a predetermined diameter that is variable under axial movement of ends of the body relative to each other and which is composed of a plurality of individually rigid but flexible and elastic thread elements defining a radially self-expanding helix. This type of stent is known in the art as a "braided stent" and is so designated herein.

[006 J Other types of self-expanding stents use alloys such as Nitinol (Ni-Ti alloy) which have shape memon' and/or superelastic characteristics in medical devices that are designed to be inserted into a patient's body. The shape memory characteristics allow the devices to be deformed to facilitate their insertion into a body lumen or cavity and then be heated within the body so that the device returns to its "memorized" shape. Superelastic characteristics on the other hand generally allow the metal to be deformed and restrained in the deformed condition to facilitate the insertion of the medical device containing the metal into a patient's body , with such deformation causing the phase transformation. Once within the body lumen the restraint on the superelastic member can be removed, thereby reducing the stress therein so that the superelastic member can return to its original un-deformed shape by the transformation back to the original phase, or close to it (as the implanted shape is designed to have some deformation to provide a force to prop open the vessel in which it is implanted).

[007] Alloys having shape memory /'superelastic characteristics generally have at least two phases. These phases are a martensitic phase, which has a relatively low tensile strength and which is stable at relatively low temperatures, and an austenitic phase, which has a relatively high tensile strength and which is stable at temperatures higher than the martensitic phase. [008] When stress is applied to a specimen of a metal such as Nitinol exhibiting superelastic characteristics at a temperature above which the austenite is stable (i.e. the temperature at which the transformation of martensitic phase to the austenite phase is complete), the specimen deforms elasticaliy until it reaches a particular stress level where the alloy then undergoes a stress-induced phase transformation from the austenitic phase to the martensiie phase. As the phase transformation proceeds, the alloy undergoes significant increases in strain but with little or no corresponding increases in stress. The strain increases while the stress remains essentially constant until the transformation of the austenite phase to the martensiie phase is complete. Thereafter, further increase in stress is necessary to cause further deformation. The martensitic metal first deforms elasticaliy upon the application of additional stress and then plastically with permanent residual deformation.

[009] If the load on the specimen is removed before any permanent deformation has occurred, the martensitic specimen will elasticaliy recover and transform back to the austenite phase. The reduction in stress first causes a decrease in strain. As stress reduction reaches the level at which the martensitic phase transforms back into the austenite phase, the stress level in the specimen will remain essentially constant (but substantially less than the constant stress level at which the austenite transforms to the martensite) until the transformation back to the austenite phase is complete, i.e. there is significant recovery in strain with only negligible corresponding stress reduction. After the transformation back to austenite is complete, further stress reduction results in elastic strain reduction. This ability to incur significant strain at relatively constant stress upon the application of a load and to recover from the deformation upon the removal of the load is commonly referred to as superelasticity or pseudoelasticity. It is this property of the material which makes it useful in manufacturing tube cut self- expanding stents. The prior art makes reference to the use of metal alloys having superelastic characteristics in medical devices which are intended to be inserted or otherwise used within a patient's body . See for example, U.S. Pat. No. 4,665,905 (Jervis) and U.S. Pat. No. 4,925,445 (Sakamoto et al.).

[0010] A now conventional deliveiy system for a self-expanding stent is a so-called "pin and pull" system. The following is an example of a "pin and pull" system. The deliveiy system includes an outer sheath, which is an elongated tubular member having a distal end and a proximal end and a lumen therethrough. A typical outer sheath is made from an outer polymeric lay er, an inner polymeric layer, and a braided reinforcing layer between the inner and outer layers. The reinforcing layer is more rigid than the inner and outer layers. It is this outer sheath which is "pulled" in the "pin & pull" system. The "pin & pull" system further includes an inner shaft located coaxially within the outer sheath. The shaft has a distal end, extending distal of the distal end of the sheath, and a proximal end, extending proximal of th e proximal end of the sh eath. It is this shaft which is "pinned" in the "pm & pull" system.

10011] A "pin & pull" system further has a structure to limit the proximal motion of the self-expanding stent relative to the shaft, such as a ring fixedly attached to the inner shaft to serve as a stationary proximal stop against which the crimped stent can load in the proximal direction as the outer sheath is withdrawn proximally during deployment. This "stent stopping" structure is located proximal to the distal end of the sheath. A tapered distal tip at the end of the inner shaft may be sized to contact the inner diameter of the outer sheath and may also be referred to as a nose cone or a dilator.

[0012] Lastly, a "pin & pull" system includes a self-expanding stent located within the sheath. The stent in its reduced diameter state for delivery makes frictional contact with the inner diameter of the outer sheath, more specifically, with the inner diameter of the inner layer of the outer sheath. The stent is located between the stop structure and the distal end of the sheath, with a portion of the sh aft disposed coaxially within a lumen of the stent. The stent makes contact with the stop structure during deployment as the sheath is withdrawn and moves the stent with it (due to the frictional contact between the stent and the inner diameter of the sheath). The proximal motion of the proximal end of the stent is stopped as it comes into contact with the stop structure and the stop structure provides a counteracting force on the stent, equal and opposite to the frictional force from the sheath on the stent.

[0013] To deploy a stent from a "pin & pull" system, the system is navigated to the treatment location. Then the inner shaft, which extends proximal of the proximal end of the outer sheath is held fixed against the patient with one hand of the operator (medical professional). This action fixes the location of the inner shaft along a longitudinal axis of the patient's lumen being stented. This action is the "pin" step in the "pin & pull" system. The physician takes his or her other hand and pulls the outer sheath proximally (drawing some of it out of the patient toward the "pinning'* hand) to unconstrain, expose, and deploy the stent. This action is the ''pull" step in the "pin & pull" system.

10014] An early example of another "pin & pull" system is the Gianturco stent deliver}' system as described in U.S. Patent 4,580,568 issued April 8, 1986. In this prior art delivery system, the outer sheath is a tube of a single material, which does not have a reinforcing structure within it. A cylindrical flat end pusher, having a diameter almost equal to the inside diameter of the sheath is inserted into the sheath behind the stent. The pusher or inner shaft is then used to push the stent from the proximal end of the sheath to the distal end of the sheath. Deployment of the stent is accomplished by holding the inner shaft fixed with respect to the patient's body and pulling back on the sheath to expose the stent, which expands upon removal of the radially restraining force, as illustrated in FIGS. 4 & 5 of U.S. Patent 4,580,568, which are incorporated herein by reference.

[0015] Another early self-expanding stent on the market was the Walistent. It was braided and changed both length, which shortened, and diameter, which increased, when it was deployed, and the change to its length was appreciable. U.S. Patent 4,655,771 to Walisten, herein after "Wallsten", describes a couple of deliver}' systems for a braided stent, called a "tubular body" in the patent. One of the delivery systems is illustrated in FIG. 11 of Wallsten, which is described as follows, "[i]n FIG. 1 1 there is shown another embodiment of the assembly for use in expanding the tubular body. This assembly constitutes a flexible instrument intended to introduce the tubular body in contracted state into for example a blood vessel and then to expand the body when located therein. The parts of the instrument consist of an outer fl exible tube 61 and a concentric also flexible inner tube 62. At one end of the outer tube an operational member 63 is arranged. Another operational member 64 is attached to the free end of inner tube 62, In this manner the inner tube 62 is axially displaceable in relation to the outer tube 61. At the other end of inner tube 62 a piston 65 is attached which when moving runs along the inner wall of outer tube 61. When the instrument is to be used the tubular expansible body 69 in contracted state is first placed inside tube 61, the inner tube 62 with the piston 65 being located in the rear part 66 of outer tube 61. The starting position of piston 65 is shown by dashed lines at 67 in FIG. 11. In this manner part of tube 61 is filled with the contracted tubular body 69 in the starting position. During implantation the flexible tubular part of the device is inserted to the location of a blood vessel intended for implantation. Member 64 is then moved in the direction of arrow 68, the contracted body 69 being pushed out through end 70 of lube 61 , the part of the tubular body 69 leaving tube end 70 expanding until in its expanded position 71 it is brought to engagement with the interior of vascular wail 72. The tubular body 69, 71 is for sake of simplicity shown in FIG. 11 as two sinus-shaped lines. To the extent that the expanded body 21 comes into engagement with vascular wall 72 tube end 70 is moved by moving member 63 in the direction of arrow 73. The contracted body 69 is moved by the piston 65 pushing against one end of the body. Thus, the implantation takes place by simultaneous oppositely directed movements of members 64 and 63, the displacement of member 64 being larger than that of member 63." Like the deliver}' system for the Gianturco stent, its sheath was not reinforced, but was a single material tube, and its inner shaft did not extend through the stent, but terminated at the proximal end of the stent constrained at the distal end of the outer sheath. The inner shaft was coaxial with the outer sheath, and had an outer diameter that was larger than the inner diameter of the reduced diameter "constrained" or crimped stent.

| 0016] When a self-expanding stent transitions from its configuration as constrained for delivery to its deployed, expanded state within the lumen of a patient's vessel, the overall length may decrease due to an effect known as foreshortening. The amount of foreshortening that occurs depends upon the design of the stent as well as the amount of radial expansion experienced during deployment. The exact geometry of the patient's vessel may not be known and may be subject to variances and irregularities, including differing degrees of vessel calcification. Percent foreshortening is typically defined as the change in stent length between the deliver ' catheter loaded condition (crimped) and the nominal deployed diameter (i.e., the labeled diameter which the stent is intended to have when deployed, i.e., a "10 mm stent" has a nominal deployed diameter of 10 mm.) divided by the length of the stent in the delivery catheter loaded condition (crimped), multiplied by 100. Some self-expanding stents are designed to limit the stent foreshortening to an amount that is not appreciable (e.g., less than 10%). Nevertheless, due to design, deployment environment and other factors, a self-expanding stent may foreshorten an appreciable amount (e.g., more than 10%). [0017] When appreciable foreshortening occurs, it may be more difficult to deploy the stent at its intended axial location within a body lumen or cavity, such as a vessel, artery, vein, or duct. Hie foreshortening effect raay be manifest at the distal end of the stent, which may move proximally as the stent is being deployed in the body lumen or cavity, at the proximal end, such as when the distal end of the stent expands and engages the inner vessel wall, or both. Due to these movements caused by

foreshortening, the stent may be displaced from its intended position, resulting in deployment in an incorrect or suboptimal location.

10018] Deployment of a self-expanding stent at an unintended location may not address the condition being treated, such as when the stent does not cover the full length of the diseased portion of the vessel or does not bridge the aneurysm. Conventional strategies employed in these situations may involve placing an additional stent in an overlapping position. Nevertheless, this increases the length and difficulty of the procedure. Further, deployment at an unintended location may undesirably interfere with the vasculature anatomy, such as by blocking connection with another vessel. As such, it may be desirable to reposition the misplaced stent rather than deploying an additional stent.

[0019] To facilitate repositioning a stent, techniques exist for reconstraining a stent within the outer sheath of the delivery system before the stent is fully deployed and the proximal end of the stent remains within the outer sheath. The stent may be

reconstrained by advancing the outer sheath distally to slide over the stent and radially compress it back to its crimped diameter. To resist the axial force of the sheath on the stent due to friction as the sheath is advanced over the stent, the proximal end of the stent may be restrained from distal motion relative to the sheath and inner member. A number of delivery system designs provide features to restrain the proximal end of the stent from distal motion, see, e.g., co-pending, commonly-assigned U.S. Patent Application Serial No, 12/573,527, Attorney docket number FSS5004USNP, filed October 5, 2009 and Serial No. 13/494,567, Attorney docket number FSS5004USCIP, filed June 12, 2012, both of which are incorporated by reference herein, as well as European Patent Publication No. 0696442 A2, and U.S. Patent Publication No.

2007/0233224 Al . . One less than optimal performance of the existing device is the need to take up a slack between an annular lock member and a proximal stop member for the stent when an elongated catheter member 14 is pulled back towards the operator (i.e., proximally) for deployment of the stent.

SUMMARY

[0020] Accordingly, we have recognized that it would be desirable for users in the art to provide self-expanding stent deliver}' systems and methods that facilitate

reconstraining a partially deployed stent to allow for repositioning. Likewise, it would be desirable to provide self-expanding stent deliver)'- systems and methods that compensate for stent foreshortening. The techniques of this disclosure as described in the following materials satisfy these and other goals.

[0021 ] This disclosure includes an intravascular device for deploying and reconstraining an expandable intraluminal device having a housing that extends along a longitudinal axis, a first elongated tubular member extending from the housing and capable of axial motion relative to the housing, a second elongated tubular member extending from the housing and capable of axial motion relative to the housing having a distal end with a radially projecting distal stop, wherein the second elongated tubular member is coaxially disposed within the first elongated tubular member, an annular lock configured to secure an expandable intraluminal device in first state and release the intraluminal device in second state, wherein the annular lock is coaxially disposed over the second elongated tubular member and is coaxially disposed within the first tubular member and wherein the annular lock has an inner diameter that is less tha an effective outer diameter of the distal stop, a rotary knob on the housing coupled to the first elongated tubular member by a flexible loop member such that manipulation of the rotary knob axially moves the first elongated tubular member relative to the housing and a slider on the housing coupled to the flexible loop member.

[0022] In one aspect, the rotary knob provides a mechanical advantage such that the corresponding axial movement of the first elongated tubular member relative to the housing is less than the input movement. 10023 ] In one aspect, the annular lock may have a plurality of recesses configured to capture elements of the expandable intraluminal device.

[0024] In one aspect, the device may include a factional actuator coaxialiy disposed over the first elongated tubular member distal of the housing,

[0025] In one aspect, the device may include an inner elongated tubular member coaxialiy disposed within the second elongated tubular member and extending from the housing past the distal stop, wherein the inner elongated tubular member comprises a lumen, a proximal port in fluid communication with the lumen and a distal portion having a plurality of perforations in fluid communication with the lumen. The intravascular device may also have a tapered distal tip with a plurality of flutes configured to allow egress of fluid supplied from the perforations of the inner elongated tubular member when the distal tip abuts a distal end of the first elongated tubular member.

[0026] This disclosure also includes a reconstrainable stent delivery system having a housing that extends along a longitudinal axis, a first elongated tubular member extending from the housing and capable of axial motion relative to the housing, a second elongated tubular member extending from the housing and capable of axial motion relative to the housing having a distal end with a radially projecting distal stop, wherein the second elongated tubular member is coaxialiy disposed within the first elongated tubular member, an annular lock coaxialiy disposed over the second elongated tubular member and coaxialiy disposed within the first tubular member, wherein the annular lock has an inner diameter that is less than an effective outer diameter of the distal stop, a self-expanding stent releasably secured to the annular lock, a rotary knob on the housing coupled to the first elongated tubular member by a flexible loop member such that manipulation of the rotary knob axially moves the first elongated tubular member relative to the housing and a slider on the housing coupled to the flexible loop member,

[0027] Tills disclosure also includes a method for deploying and reconstraining an expandable intraluminal device. The method may involve providing an intravascular device having a housing that extends along a longitudinal axis, a first elongated tubular member extending from the housing and capable of axial motion relative to the housing, a second elongated tubular member extending from the housing and capable of axial motion relative to the housing having a distal end with a radially projecting distal stop, wherein the second elongated tubular member is coaxially disposed within the first elongated tubular member, an annular lock releasably securing an expandable intraluminal device, wherein the annular lock is coaxially disposed over the second elongated tubular member and is coaxially disposed within the first tubular member and wherein the annular lock has an inner diameter that is less than an effective outer diameter of the distal stop, a rotary knob on the housing coupled to the first elongated tubular member by a flexible loop member and a slider on the housing coupled to the flexible loop member; positioning a distal end of the intravascular device at a desired location within a patient's vasculature; and manipulating the rotary knob to axial K move the first elongated tubular member relative to the housing so that a portion of the expandable intraluminal device is exposed.

[0028] In one aspect, the method may also involve manipulating a slider on the housing coupled to the flexible loop member to axially move the first elongated tubular member proximally relative to the housing.

10029] In one aspect, a second actuator on the housing that is coupled to the second elongated tubular member may be manipulated to axially move the second elongated tubular member proximally relative to the housing until the distal stop engages the annular lock. Further, the first elongated tubular member may be moved distal ly relative to the housing to reconstrain the expandable intraluminal device. Force may be applied to the second actuator while axially moving the first elongated tubular member distally to keep the distal stop engaged with the annular lock.

[0030] In one aspect, accessing the second actuator may include removing a cover disposed over the second actuator so that the second actuator is visible when the cover is removed.

[ 0031 ] In one aspect, a friciionai actuator coaxially disposed over the first elongated tubular member distal of the housing may be manipulated when axially moving the first elongated tubular member distally relative to the housing. 10032] In one aspect, the intravascular device may have an inner elongated tubular member coaxially disposed within the second elongated tubular member and extending from the housing past the distal stop, wherein the inner elongated tubular member includes a lumen, a proximal port in fluid communication with the lumen and a distal portion having a plurality of perforations in fluid communication with the lumen.

Irrigation fluid may be supplied to the proximal port prior to positioning the distal end of the intravascular device at the desired l ocation to cause the irrigation fluid to flow from the perforations. The intravascular device may have a tapered distal tip with a plurality of flutes so that supplying the irrigation fluid to the proximal port causes the irrigation fluid to be communicated through the perforations of the third elongated tubular member and flow out the flutes when the distal tip abuts a distal end of the first elongated tubular member.

BRIEF DESCRIPTION OF THE DRAWINGS

[0033 J Further features and advantages will become apparent from the following and more particular description of the preferred embodiments of the disclosure, as illustrated in the accompanying drawings, and in which like referenced characters generally refer to the same parts or elements throughout the views, and in which:

10034] FIG. 1 illustrates a reconstrainabie stent delivery system in an initial configuration, according to an embodiment;

[0035] FIG. 2 illustrates a reconstrainabie stent delivery system with a stent partially deployed, according to an embodiment;

[0036] FIG. 3 illustrates a reconstrainabie stent delivery system in preparation for reconstraining, according to an embodiment;

[0037] FIG. 4 illustrates a reconstrainabie stent delivery system during

reconstraining, according to an embodiment;

[0038] FIG. 5 illustrates a reconstrainabie stent deliver ' system following reconstraining, according to an embodiment;

[0039] FIG. 6 illustrates a reconstrainabie stent deliver}' system being returned to a deployment configuration, according to an embodiment; 10040] FIG. 7 illustrates an interior view of the housing of a reconstrainable stent delivery system, according to an embodiment;

[0041 ] FIG. 8 A illustrates actuator elements of a reconstrainable stent delivery system, according to an embodiment;

[0042] FIG. 8B illustrates an alternative embodiment for the actuator of the system shown in Fig. 8A;

[0043] FIG. 8C illustrates in perspective view the relevant components of the actuator in Fig. 8B;

[0044] FIG. 8D illustrates in a perspective and exploded view of the components at the proximal end of the handle;

[0045] FIG. 9 illustrates a directional control assembly of a reconstrainable stent delivery system, according to an embodiment;

[0046] FIG. 10 illustrates a directional control assembly of a reconstrainable stent deliver}' system in a stent deployment configuration, according to an embodiment;

[0047] FIG. 1 1 illustrates a directional control assembly of a reconstrainable stent deliver}' system in a stent reconstraining configuration, according to an embodiment;

[0048] FIG. 12 illustrates a reconstrainable stent delivery system, according to another embodiment;

[0049] FIG. 13 illustrates a reconstrainable stent deliver}' system with a proximal stop, according to an embodiment;

[0050] FIG. 14A illustrates a reconstrainable stent delivery system with a single port flushing, according to an embodiment;

[0051] FIG. I4B illustrates a perspective view of the underside or internal surface of a removable cover;

[0052] FIG. 15 illustrates an end view of a reconstrainable stent delivery system with a single port flushing, according to an embodiment; [0053 ] FIG. 16 illustrates a self-expanding stent in a constrained configuration, according to an embodiment; and

[0054] FIG. 17 illustrates a self-expanding stent in a deployed configuration, according to an embodiment.

DETAILED DESCRIPTION

[0055] At the outset, it is to be understood that this disclosure is not limited to particularly exemplified materials, architectures, routines, methods or structures as such may vary. Thus, although a number of such options, similar or equivalent to those described herein, can be used in the practice or embodiments of this disclosure, the preferred materials and methods are described herein.

[0056] It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments of this disclosure only and is not intended to be limiting.

[0057] The detailed description set forth below in connection with the appended drawings is intended as a description of exemplary embodiments of the present disclosure and is not intended to represent the only exemplary embodiments in which the present disclosure can be practiced. The term "exemplary" used throughout this description means '"serving as an example, instance, or illustration," and should not necessarily be construed as preferred or advantageous over other exemplary

embodiments. The detailed description includes specific details for the purpose of providing a thorough understanding of the exemplary embodiments of the specification. It will be apparent to those skilled in the art that the exemplary embodiments of the specification may be practiced without these specific details. In some instances, well known structures and devices are shown in block diagram form in order to avoid obscuring the novelty of the exemplary embodiments presented herein.

[0058] For purposes of convenience and clarity only, directional terms, such as top, bottom, left, right, up, down, over, above, below, beneath, rear, back, and front, may be used with respect to the accompanying drawings. These and similar directional terms should not be construed to limit the scope of th e disclosure in any manner. [0059] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one skilled in the art to which the disclosure pertains.

[0060] As used herein, the term "expandable intraluminal device" includes not only devices that are expandable by another device, e.g., a balloon, but also those that are self-expandable without requiring another device for expansion into its operational configuration. Finally, as used in this specification and the appended claims, the singular forms "a, "an" and "the" include plural referents unless the content clearly dictates otherwise.

[0061 ] In stent delivery systems where the self-expanding stent is in factional contact with the inner diameter of the elongated tubular member, such as those including self-expanding stents made from nitinol, the friction may be quite high. Without a proximal stop or some other mechanism to counteract the proximal forces on the stent, withdrawing the outer elongated tubular member proximally may not succeed in exposing, and thereby releasing, the stent. Instead the stent may be pulled proximally with the tubular member. Thus, most self-expanding stent delivery systems have a structure called a proximal stop that applies equal and opposite forces to the proximal end of the stent when the outer tubular member is proximally translated to expose and deploy the stent. Depending on the design of the stent, this may spring load the stent against the stop, and the distal end may spring distally when the distal end is no longer constrained by the outer tubular member. This motion, along with foreshortening of a stent upon expansion, can result in the stent being deployed longitudinally in the axis of the vessel at a location other than the desired one. To address these and other situations when a partially deployed stent is determined to be in a suboptimal location, the techniques of this disclosure provide a stent delivery system with the ability to reconstrain a partially deployed stent to repositioning the stent for deployment at a more desired location.

[0062] Reconstraining invol ves advancing the outer tubular member distally so that it slides over and compresses the expanded stent until the entire length of the stent is constrained and is no longer in contact with the vessel wall. When returned to this configuration, the stent may be repositioned without risk of stretching or otherwise traumatizing the vessel. Thus, a stent delivery system of this disclosure may include a proximal stop to apply counteracting distal forces on the proximal end of the stent to counteract the proximal friction forces along the o uter diameter of the stent in contact with the outer tubular member to allow the tubular member to be withdrawn to expose the stent during deployment. At the same time, a stent delivery system of this disclosure may feature a distal stop structure to exert proximaliy acting forces that counteract the distally acting friction forces associated with advancing the tubular member over the outer diameter of the stent during reconstraining.

[0063] Failure to provide sufficient counteracting force when the tubular member is advanced distally may have undesirable consequences. For example, the distal end of the stent may be in contact with the vessel wall after being partially deploy ed, such that distal motion of the stent due to the friction with the outer tubular member may cause the portion of the stent immediately distal to the distal end of the constraining tubular member to invert into the released portion of the (partially) deployed stent as one portion of the stent at a smaller diameter is ad vanced toward a relati vely stationary- expanded diameter distal end of the stent. As another example, the expanded portion of the stent that is in contact with the vessel wall may be slid distally, causing trauma. Systems are known in the art for providing structures to provide suitable counteracting proximal force as discussed above. However, a stent that exhibits appreciable foreshortening may have a substantial increase in length upon reconstraining.

Accordingly, the techniques of this disclosure provide counteracting proximaliy oriented force on the stent as it is being reconstrained in a manner that compensates for this length increase.

[0064] One reconstrainable stent delivery system embodiment includes

intravascular device 10 as schematically illustrated in FIG. 1, and may generally feature a housing 12 that extends along a longitudinal axis L-L, a first elongated tubular member 14 (which also may be termed a sheath or outer member) extending from housing 12 and capabl e of axial motion with respect to housing 12 and a second elongated tubular member 16, also extending from housing 12 and capable of axial motion with respect to housing 14. First elongated tubular member 14 may have any suitable construction, such as a composite construction of an extruded polymer and a reinforcing layer, such a metal braid, encased in polymers, as is known by one skilled in the art. Second elongated tubular member 16 is coaxiaily disposed within first elongated tubular member 14. Housing 12 carries a plurality of actuators that may be manipulated to effect movement of first elongated tubular member 14 and second elongated tubular member 16 relative to housing 12.

10065] As shown, a first actuator is configured as a rotary knob 18. For example, rotary knob 18 may be a thumbwheel formed form a short cylinder that may have a knurled or otherwise textured outer diameter to assist in transferring the force from the operator to the thumbwheel without slipping. Depending on the direction knob 18 is rotated, first elongated tubular member 14 may be advanced or withdrawn with respect to housing 12. A second actuator is configured as a slider 20 in this embodiment (e.g., tab, button, or knob). Slider 20 may be coupled to second elongated tubular member 16 so that movement of slider 20 in a proximal direction withdraws second elongated tubular member 16 relative to housing 12 and movement of slider 20 in a distal direction advances second elongated tubular member 16 relative to housing 12.

[0066] Generally, slider 20 may be coupled to second elongated tubular member 16 so that linear motion of slider 20 is translated into linear motion of second elongated tubular member 6 in a 1 : 1 ratio. Slider 20 has a range of travel from a most distal position to a most proximal position. As will be described below for some

embodiments, slider 20 engages a directional control associated with rotary knob 18 (not shown in FIG. 1) when in its most distal position, such that knob 18 may only be rotated in the direction that withdraws first elongated tubular member 14 relative to housing 12. Correspondingly, movement of first elongated tubular member 14 is restricted to proximal motion. When slider 20 is moved proximally from its most distal position, it disengages the directional control, so that knob 18 may only be rotated in the direction that advances first elongated tubular member 14, restricting first elongated tubular member 14 to only distal motion.

10067] An inner tubular member 22 may also extend from housing 12 and have a fixed relation to the housing, terminating at its distal end in enlarged, tapered tip 24, which may be integral or separate and may also be termed a nose cone or dilator. Inner tubular member 22 has a lumen 26 extending between its proximal and distal ends. The inner tubular member may be made from polyimide or other combinations of polymers known to those skilled in the art for guide wire tubes. In one aspect, distal tip 24 maybe radiopaque. Lumen 26 may be sized to closely track over a guide wire 28. As shown, guide wire 28 may extend proximally from housing 12 through a suitable valve 30, such as a luer lock, that is in fluid communication with lumen 26 and guide wire 28 may also extend distaily beyond tip 24. In embodiments for use without a guide wire, the inner member may be a solid elongated cylindrical member, without a lumen.

[0068] A stent 32 may be disposed within the distal end of first elongated tubular member 14, such that the inner diameter of first elongated tubular member 14 constrains stent 32 in its crimped configuration. When crimped, stent 32 engages annular lock 34, restricting longitudinal movement of stent 32 relative to annular lock 34, and when stent 32 expands during deployment, it is released from annular lock 34. Annular lock 34 may hav e a maximum outer dimension less than the inner diameter of first elongated tubular member 14 to reduce friction during deployment or reconstraining of stent 32 by- withdrawing or advancing first elongated tubular member 14, respectively.

[0069] The distal end of second elongated tubular member 16 extends beyond annular lock 34 and includes a radially projecting distal stop 36 having an effective outer diameter that is greater than the inner diameter of annular lock 34, so that proximal movement of second elongated tubular member 16 may cause distal stop 36 to engage annular lock 34. The outer dimension of the distal stop 36 is less than the inner diameter of stent 32 when the stent is crimped so that distal stop 36 may be moved distaily of annular lock 34 without interference from stent 32. Any suitable construction may be employed for second elongated tubular member 16, including braid-reinforced polyimide for example. When slider 20 is at its most distal position with respect to housing 12, distal stop 36 may be at a predetermined location that is spaced a desired distance from the initial position of annular lock 34 to accommodate distal movement of annular lock 34 due to foreshortening as stent 32 is expanded during deployment.

[0070] A third elongated tubular member 38 may also extend in fixed relation from housing 12, having a distal end with a diameter that is configured to engage annular lock 34 from the proximal direction, such that the end of third elongated tubular member 38 functions as a proximal stop 40. Third elongated tubular member 38 may be coaxially disposed within first elongated tubular member 14 and coaxially disposed over second elongated tubular member 16. Since third elongated tubular member 38 has a fixed relation to housing 12, proximal stop 40 also maintains a fixed position, while first elongated tubular member 14 and second elongated tubular member 16, along with distal stop 36, may be advanced or withdrawn relative to it upon appropriate manipulation of knob 18 and slider 20, respectively. Third elongated tubular member 38 may have varying physical properties over the length, such as by having a relatively flexible distal length formed from polymeric materials and a relatively rigid proximal length formed from a stainless steel hypotube, for example. In alternative constructions, third elongated tubular member 38 may have substantially constant physical properties of flexibility over the overall length. An example of a suitable polymeric material that may be used in the construction of third elongated tubular member 38 is poly ether ether ketone (PEEK).

10071 ] In the embodiment shown, housing 12 features another actuator in the form of a fast deploy slider 42. As will be described in detail below, slider 42 may be fixed to first elongated tubular member 14 within housing 12 so that an operator may manipulate slider 42 to achieve a 1 : 1 relative movement of first elongated tubular member 14 to either deploy or reconstrain stent 32. Fast deploy slider 42 may have a range of travel on housing 12 sufficient to allow first elongated tubular member 14 to be fully withdrawn to completely expose stent 32 for deployment. There may be a proximal limit to the range of travel beyond this length. In the illustrated embodiment, the profile of fast deploy slider 42 does not extend beyond the outermost surface of housing 12 to reduce the possibility of unintended translation of the slider due to a projecting structure catching on something.

[0072] In another aspect, intravascular device 10 may also have a frictional actuator to facilitate direct manipulation of first elongated tubular member 14 in the form of gripper 44. In one embodiment, gripper 44 may formed from a resilient polymeric material coaxialiy disposed over first elongated tubular member 14. Generally, gripper 44 is positioned distal to housing 12, but remains proximal to the point of entry to the patient. Although gripper 44 may be slid coaxialiy along first elongated tubular member 14, when inward pressure is applied it may exhibit a greater degree of fri ction with first elongated tubular member 14 and allow manual advancement or withdrawal of the tubular member. For example, the length of first elongated tubular member 14 outside the patient's body may be such that the tubular portions of intravascular device 10 would tend to buckle if the actuators on housing 12 alone were manipulated to achieve the desired movement of first elongated tubular member 14 or other tubular members. Correspondingly, gripper 44 allows force to be exerted to first elongated tubular member 14 at a location much closer to the patient's body to reduce any buckling tendency.

[0073] As an example only, and without limitation, an operator may initiate deployment of stent 32 by manipulating knob 18, which may provide a mechanical advantage to allow a greater degree of control over movement of first elongated tubular member 14. Once the operator is satisfied with placement of stent 32, it may be desirable to manipulate fast deploy slider 42 to complete the withdrawal of first elongated tubular member 14 and release stent 32. However, if it becomes desirable to reconstrain stent 32 before complete deployment, the operator may manipulate knob 18 in the opposite direction and/or use gripper 44 to advance first elongated tubular member 14 back over stent 32.

[0074] To facilitate placement of stent 32 at a desired location within the patient's vasculature, one or more radiopaque markers may be affixed to location(s) of the tubular members of intravascular device 10. For example, marker 46 is illustrated on inner tubular member 22. Although shown as being located distal to distal stop 36 for ease of illustration purposes only, marker 46 may be positioned as desired to provide feedback as to the placement of stent 32 and/or to indicate a limit of the amount first elongated tubular member 14 may be withdrawn before reconstraining stent 32 may no longer be practical or safe.

[0075] As will be appreciated, marker 46 may be configured as a proximal placement marker for initial positioning of the delivery system and during retraction of first elongated tubular member 14 to deploy stent 32, The proximal placement marker may be used as an indication of the axial location where the proximal end of the stent will land on the vessel wall if deployed to its nominal diameter. Since inner tubular member 22 remains fixed with respect to housing 12, marker 46 may remain constant during the procedure. Where the proximal end of the stent is estimated to land is useful information for an operator, and having the proximal placement marker move axially at times during the procedure could lead to error in placing the stent, or unnecessary reconstraining and redeployment, if such movement is not accounted for by the operator. 10076] In another aspect, marker 46 may be positioned to function as a

reconstraining limit marker as noted. This is useful information for an operator by indicating the furthest retraction of first elongated tubular member 14 after which stent 32 may still be reliably reconstrained, and could be viewed while looking at the fluoroscope (showing all radiopaque structures in the target area). As will be discussed below, a reconstraining limit marker may alternatively or additionally located on housing 12 with respect to a position of fast deploy slider 42.

[0077] The configuration of FIG, 1 illustrates intravascular device 10 as ready to be advanced over guide wire 28 to a desired location in a patient's vasculature for deployment of stent 32, such as within a bodily lumen defined by vessel walls 48. As shown, annular lock 34 is engaged by proximal stop 40 to resist proximal movement of stent 32 when first elongated tubular member 14 is withdrawn. Exemplar}' operations and manipulations of actuators including knob 18 and slider 20 and the resulting effects at the distal end of intrav ascular device 10 to deploy and reconstrain stent 32 are schematically shown in Figs 2-6, A benefit of having annular lock 34 abutting proximal stop 36 in an initial configuration in the body is that the operator may immediately begin retracting first elongated tubular member 14 when the distal radiopaque stent markers are disposed at the target location, without having to close a gap between the proximal stop and the annular lock prior to deployment. This simplifies and reduces the time associated with the procedure, and provides an attendant reduction in the amount of radiation to which the patient may be exposed.

[0078] Beginning with FIG. 2, once intravascular device 10 has been advanced to the desired location within the patient's vasculature, the operator may rotate knob 18 (and/or manipulate fast deploy slider 42) as shown to withdraw first elongated tubular member 14. As first elongated tubular member 14 is withdrawn from stent 32, the portion of stent 32 that is freed from constraint expands within the vessel to come in contact with the vessel wall 48 of the body lumen. As this is an appreciably

foreshortening stent, the overall length of the stent 32 has shortened, and at least some of that shortening has occurred within first elongated tubular member 14. The distal end of stent 32 that has been expanded into contact with vessel wall 48 may keep it relatively stationary within the vessel. Accordingly, the proximal end of stent 32 and releasabiv secured annular lock 34 have axialiy translated distaily within first elongated tubular member 14 as shown by the space between proximal stop 40, which may be fixed with respect to housing 12 and the patient, and annular lock 34.

[0079] The position of second elongated tubular member 16, and correspondingly distal stop 36, have remained relatively stationary, with distal stop 36 positioned sufficiently distal to the distal end of the pusher tube proximal stop 40 that

foreshortening of stent 32 may not pull annular lock 34 into contact with it or otherwise limit distal motion of stent 32 due to foreshortening. If the operator is satisfied with the location of the deployed stent, first elongated tubular member 14 may be fully retracted the proximal end of stent 32, allowing it to expand into contact with vessel 48 along its entire length and release from annular lock 34 due to the radial expansion. As can be seen, fast deploy slider 42 has also been translated proximailv with respect to housing 12 as first elongated tubular member 14 is withdrawn. Deployment of stent 32 may be accomplished by either or both rotary knob 18 and slider 42 as desired.

[0080] Alternatively, if repositioning stent 32 is desired, and first elongated tubular member 14 has not been withdrawn past a suitable reconstraining limit mark (such as mark 46), reconstraining of stent 32 may be performed as described with respect to Figs 3-5. To begin the reconstraining operation as schematically depicted in FIG. 3, slider 20 may be manipulated to move proximailv from its distal most position on housing 12. As slider 20 moves proximailv, it causes a corresponding proximal movement of second elongated tubular member 16 until distal stop 36 engages annular lock 34. Resistance may be felt when distal stop 36 contacts annular lock 34. Due to foreshortening, relatively less proximal movement of slider 20 may be associated with engaging distal stop 36 and annular lock 34 when a greater portion of stent 32 has been deployed. As will be described in further detail below, displacing slider 20 proximailv may disengage a directional control associated with knob 18, allowing first elongated tubular member 14 to be advanced while preventing further withdrawal.

[0081 ] Next, FIG. 4 schematically depicts advancement of first elongated tubular member 14 to reconstrain stent 32. Advancement of first elongated tubular member 14 may be performed by manipulation of knob 18 and/or slider 42. However, due to friction that may occur at the hemostasis valve of an introducer that interfaces with the patient or other sources, it may be desirable to manipulate gripper 44 to push first elongated tubular member 14 into the patient's body, causing it to advance over and reconstrain stent 32. As described above, gripper 44 may be positioned relatively close to the introducer to reduce the tendency of first elongated tubular member 14 to buckle as the pushing force is exerted.

10082] The operator may use tactile feedback to maintain a desired level of tension on slider 20 to maintain engagement of distal stop 36 with annular lock 34 and compensate for any relative proximal movement of stent 32 as its length increases due to being reconstrained. Keeping distal stop 36 in contact with annular lock 34 with a desired amount of proximal force may keep stent 32 in tension and assists the advancement of first elongated tubular member 14 over stent 32 rather than pushing the constrained portion of stent 32 distally, which might result in unintended movement of the stent in the vasculature. The proximal force applied to distal stop 36 is not intended to pull stent 32 proximally. Due to the coupling between first elongated tubular member 14 with knob 18 and slider 42, advancement of first elongated tubular member 14 causes rotation of knob 18 and movement of slider 42 in the indicated directions, regardless of whether the operator is manipulating the actuators or using gripper 44 to achieve the advancement. Slider 20 ma}'- also move proximally as the operator applies force to keep distal stop 36 in engagement with annular lock 34 and stent 32 lengthens as it is reconstrained.

10083] When first elongated tubular member 14 has been advanced over the entire length of stent 32, intravascular device 10 may be in the configuration schematically illustrated in FIG. 5. Distal stop 36 may still be engaged with annular lock 34 and slider 20 may be positioned proximally from its distal most location relative to housing 12. However, first elongated tubular member 14 along with fast deploy member 42 have retumed to their initial positions, with stent 32 fully radially constrained. Subsequently, as schematically shown in FIG. 6, the operator may manipulate slider 20 to return it to its distal most position relative to housing 12. This causes second elongated tubular member 16 to advance distally relative to proximal stop 40, returning intravascular device 10 to the configuration shown in FIG. 1, so that stent 32 may be repositioned as desired. In embodiments with directional control, returning slider 20 to its distal most position re-engages the directional control so that first elongated tubular member 14 may be withdrawn and not advanced. [0084] Further details regarding a suitable implementation of housing 12 and its actuators are shown in Figs 7-11 for one embodiment. Beginning with FIG. 7, a schematic cut away view of housing 12 is shown. Knob 18 (removed for clarity in this view) is associated with a directional control assembly 50, which in turn is coupled as described below to the proximal end 52 of first elongated tubular member 14. Proximal end 52 is also directly coupled to fast deploy slider 42. Slider 20 is coupled by- connecting rod 54 to the proximal end 56 of second elongated tubular member 16. The proximal end 58 of third elongated tubular member 38 is affixed to housing 12 at a location between the proximal ends of first elongated tubular member 14 and second elongated tubular member 16. The proximal end 60 of inner tubular member 22 is affixed to housing 12 proximal to the proximal end 56 of second elongated tubular member 16.

[0085] As described above, this configuration allows both first elongated tubular member 14 and second elongated tubular member 16 to be advanced or withdrawn independently with respect to housing 12, while third elongated tubular member 38 and inner tubular member 22 have fixed relative positions. First elongated tubular member 14 is coaxially disposed over third elongated tubular member 38, which is coaxially disposed over second elongated tubular member 16, which is in turn coaxially disposed over inner tubular member 22. Directional control assembly 50 includes a drive gear 62 that shares an axle with and is secured to knob 18, so that knob 18 and drive gear 62 rotate in unison. The teeth of drive gear 62 mesh with dri ve pulley 64 to translate rotational movement of knob 18 to drive pulley 64. A flexible loop member (not shown in this view) is disposed around drive pulley 64 and around idler pulley 66. Slider 42 is carried by the flexible loop member and is secured to proximal end 52 of first elongated tubular member 14 as noted. If desired, gear ratios and/or pulley diameters may be adjusted to provide a mechanical advantage to facilitate withdrawal and/or advancement of first elongated tubular member 14 as described above. For example, rotational input from knob 18 may be decreased to output reduced linear output and impart greater control over the movement of first elongated tubular member 14. Alternatively, a given rotational input may be increased to achieve more rapid withdrawal or advancement as desired. 10086] Elements of the flexible loop drive train are schematically shown in FIG. 8A, with the flexible loop member implemented as belt 68 in this embodiment. As will be appreciated, the flexible loop member may also be a V-belt, a toothed belt, a chain, a tendon, or any other suitable configuration. Belt 68 travels around drive pulley 64 and idler pulley 66. Further, belt 68 is secured to slider 42, which in turn is secured to proximal end 52 of first elongated tubular member 14. Accordingly, rotational movement of knob 18 is translated into linear motion to either advance or withdraw first elongated tubular member 14 depending on the direction of rotation. The flexible loop member may be under sufficient tension as to impart the desired degree of friction with drive pulley axle 70.

[0087] Flexible loop member may be configured to exhibit relatively low elongation under the highest expected operating loads, such as approximately 3%, since any stretch in the tension member could be perceived as input lag or error to the operator.

Additionally, a spring element may be inserted into the flexible loop member path to provide a constant tension and increase friction with drive pulley 64. Alternative or additional techniques may be employed to increase friction, such as through the use of multiple wraps of the flexible loop member around the drive pulley axle. Further, a V- shaped groove may be used with a single wrap or a spiral groove for multiple wraps, to increase the engagement with the flexible loop member.

[0088] As described above, drive gear 62 may be coaxial with and secured to knob 18, so that both element turn in unison. Similarly, a ratchet wheel 70 may also be coaxial with and secured to knob 18. In the view of FIG. 8A, knob 18 and drive gear 62 are partially cut away to show ratchet wheel 70. If desired, knob 18, drive gear 62 and/or ratchet wheel 72 may be formed integrally. Connecting rod 54 may be secured to the proximal end 56 of second elongated tubular member 16 by junction 72 to offset slider 20 from the longitudinal axis of the coaxially disposed tubular members to avoid interference with slider 42, allowing them to be moved with respect to each other. For example, junction 72 may be a single integral part shaped as necessary to directly connect through fixed attachment to connecting rod 54 and the proximal end 56 of second el ongated tubular member 16, or through a number of parts , such that j unction 72 directly translates linear movement of slider 20 into linear movement of second elongated tubular member 16 in a 1 : 1 ratio. 10089] Referring to Fig. 8B, an alternative embodiment is shown of the attachment of a proximal end 58a of third elongated tubular member 38 is affixed to housing 12 via a male tab 59a (of member 58a) inserted into an opening 59b. The proximal end 58a is coupled to a slotted tubular member 57 that all ows the proximal end or shuttle 56 of the member 16 to translate in a substantially linear path along the longitudinal axis L-L with little or no buckling to the connecting rod 54 due to actuation by the slider 20. The proximal end 60 of inner tubular member 22 is affixed to housing 12 proximal to the shuttle 56 of second elongated tubular member 16.

[0090] As shown in Fig. 8C, the shuttle 56 has a portion of its outer surface captured in the slot 57a of the slotted member 57 to ensure that there is little or no deviation as the shuttle 56 is translated along axis L-L due to the external guide rail afforded by the slot 57a. As well, the shuttle 56 is provided w ith a through opening 56a in which the member 38 (not shown) acts as an internal guide rail for shuttle 56, shown here in greater details in Fig. 8D.

[0091 J Further details of one embodiment of directional control assembly 50 are shown schematically in FIG. 9, in which one or more elastically deflectable elements function as pawls that may engage teeth of ratchet wheel 70. Directional control assembly may include a first elastically deflectable element 74, having one end 76 mounted in housing 12 and an opposing free end 78 that selectively engages teeth 80 on ratchet wheel 70 to allow counterclockwise rotation and restrict clockwise rotation as indicated. Slider 20 includes a first cam 82 that engages first elastically deflectable element 74 to bring free end 78 into engagement with ratchet w heel 70 when slider 20 is in its distal most position relative to housing 12. As will be appreciated, this configuration allows rotation of ratchet wheel 70 in a counterclockwise direction (in the perspecti ve shown) as teeth 80 may deflect free end 78 of first elastically deflectable element 74 and allow rotation. However, rotation of ratchet wheel 70 in the clockwise direction does not deflect the engaged free end 78, substantially preventing rotation of ratchet wheel in this direction. Since ratchet wheel 70 is coupled to first elongated tubular member 14 as described above, first elongated tubular member 14 may be withdrawn but not advanced when slider 20 is in its distal most position and engaged with directional control assembly 50. [0092] Directional control assembly 50 may also include a second elastically deflectable element 84 having one end 86 mounted in housing 12 and an opposing free end 88 that selectively engages teeth 80 on ratchet wheel 70 to allow clockwise rotation and restrict counterclockwise rotation, A second cam 90 on slider engages second elastically deflectable element 84, disengaging free end 88 from teeth 80 of ratchet wheel 70 when slider 20 is in its distal most position relative to housing 12. In the configuration shown, second elastically deflectable element 84 is disengaged, so first elastically deflectable element 74 controls the direction of rotation of ratchet wheel 70 as described above. However, when slider 20 is moved proximally, second cam 90 disengages second elastically deflectable element 84 so that free end 88 recoils to its unbiased position, which is in engagement with teeth 80.

[0093] Similarly, first cam 82 is also disengaged from first elastically deflectable element 74 when slider 20 is moved proximally, allowing it to assume its unbiased position with free end 78 disengaged from teeth 80. Thus, proximal movement of slider 20 from its distal most position allows rotation of ratchet wheel 70 in a clockwise direction as teeth 80 may deflect free end 88 of second elastically deflectable element 84 to allow clockwise rotation. Counterclockwise rotation of ratchet wheel 70 is restricted, as this motion does not deflect the engaged free end 88. Again, since ratchet wheel 70 is coupled to first elongated tubular member 14, it may be advanced but not withdrawn when slider 20 is moved proximally from its distal most position and is disengaged with directional control assembly 50.

[0094] Illustrations of directional control assembly 50 in deploy ment and reconstraining configurations are schematically shown in Figs 10 and 11, respectively. In the deployment configuration shown in FIG. 10, slider 20 is in its distal most position relative to housing 12, so that first cam 82 engages first elastically deflectable element 74 and second cam 90 engages second elastically deflectable element 84. Engagement by first cam 82 biases first elastically deflectable element 74 from a nominally disengaged position into engagement with ratchet wheel 70 and engagement by second cam 90 biases second elastically deflectable element 84 away from its nominal engagement of ratchet wheel 70. Accordingly, ratchet wheel 70 is allowed to turn, counterclockwise and restricted from turning clockwise by first elastically deflectable element 74. Slider 20 may also have a catch 92 that latches with a projection 94 of housing 12 when in its distal most position. Accordingly, a relatively larger force may be required to deflect catch 92 than the force required to linearly translate slider 20 once released. This arrangement resists unintentional linear translation of slider 20, for example, during shipping or handling during use, and stays in the most distal position until slider 20 is intentionally moved proximaily. Also, the interaction of catch 92 and projection 94 provides positive feedback that slider 20 has been returned to its distal most position following a reconstraining operation, signaling the directional control assembly 50 has been engaged by slider 20 and first elongated tubular member 14 may now be withdrawn following repositioning of stent 32.

10095] Correspondingly, FIG. 11 depicts a reconstraining configuration in which slider 20 has been moved proximal to its distal most position as indicated. In this configuration, first cam 82 is disengaged from first elastically deflectable element 74 and second cam 90 is disengaged from second elastically deflectable element 84. First elastically deflectable element 74 returns to its unbiased position and does not engage ratchet wheel 70 and second elastically deflectable element 84 returns to its unbiased position into engagement of ratchet wheel 70. Accordingly, ratchet wheel 70 is allowed to turn clockwise and restricted from turning counterclockwise by second elastically deflectable element 84.

[0096] An alternate intravascular device 100 embodying techniques of this disclosure is schematically depicted in FIG. 12. Rather than employing a separate inner tubular member in addition to the second tubular member, features associated with the inner tubular member may be incorporated into the second tubular member. Unless otherwise noted, similar elements have corresponding reference numerals (e.g., housing 112 of intravascular device 110 corresponds to housing 12 of intravascular device 10). As such, intravascular device 100 may generally include a housing 112, a first elongated tubular member 1 14 extending from housing 1 12 and capable of axial motion with respect to housing 112 and a second elongated tubular member 116, also extending from housing 112 and capable of axial motion with respect to housing 114. A first actuator on housing 1 12 is configured as a rotary knob 118 and may advance or withdraw first elongated tubular member 1 14. A second actuator configured slider 120 is coupled to second elongated tubular member 116 so that movement of slider 120 advances and withdraws second elongated tubular member 1 16. Knob 1 18 may also have a directional control assembly as described above to restrict the direction of movement allowed to first elongated tubular member 114 depending on whether slider 120 is engaged with the directional control, i.e., in its most distal position with respect to housing 1 12. In this embodiment, second elongated tubular member 1 16 terminates at its distal end in enlarged, tapered tip 124 and has a lumen 126 extending between its proximal and distal ends. Guide wire 128 may extend proximally from housing 112 though a suitable valve 130, such as a luer lock, that is in fluid communication with lumen 126 and guide wire 128 may also extend distally beyond tip 124.

10097] In embodiments for use without a guide wire, second elongated tubular member 116 may be a solid elongated cylindrical member, without a lumen. A stent 132 may be disposed within the distal end of first elongated tubular member 1 14, constrained in crimped configuration with a releasably secured annular lock 134. The distal end of second elongated tubular member 116 extends beyond annular lock 134 and has a radially projecting distal stop 136 that may engage annular lock 134. A third elongated tubular member 138 may also extend in fixed relation from housing 1 12, having a distal end with a diameter that is configured to engage annular lock 134 from the proximal direction, forming a proximal stop 140. Third elongated tubular member 38 may have a fixed relation to housing 1 12 to maintain proximal stop 140 in a corresponding fixed position. Housing 112 may also include fast deploy slider 142 that is operative!}' connected to first elongated tubular member 114 as described above. Intravascular device 110 may have a gripper 144, also similar to the embodiments described above. Further, second elongated tubular member 1 16 may have one or more radiopaque markers, such as marker 146 to indicate proximal placement of stent 132, a reconstraining limit, or other suitable indications related to procedures to be performed with intravascular device 100.

[0098] Another embodiment of this disclosure is schematically depicted in FIG. 13, which is similar to the intravascular device of FIG. 1. Unless otherwise noted, similar elements have corresponding reference numerals (e.g., housing 212 of intravascular device 210 corresponds to housing 12 of intravascular device 10). As such, intravascular device 200 may generally include a housing 212, a first elongated tubular member 214 extending from housing 212 and capable of axial motion with respect to housing 212 and a second elongated tubular member 216, also extending from housing 212 and capable of axial motion with respect to housing 214. A first actuator on housing 212 is configured as a rotary knob 218 and may advance or withdraw first elongated tubular member 214. A second actuator configured slider 220 is coupled to second elongated tubular member 216 so that movement of slider 220 advances and withdraws second elongated tubular member 216. Knob 218 may also have a directional control assembly as described above to restrict the direction of mo v ement allowed to first elongated tubular member 214 depending on whether slider 220 is engaged with the directional control, i.e., in its most distal position with respect to housing 212. In this embodiment, inner tubular member 222 extends from, and may be in fixed relation to, housing 212. Inner tubular member 222 terminates at its distal end in enlarged, tapered tip 224 and has a lumen 226 extending between its proximal and distal ends.

[0099] Guide wire 228 may extend proximally from housing 212 though a suitable valve 230, such as a luer lock, that is in fluid communication with lumen 226 and guide wire 228 may also extend dis tally beyond tip 224. A stent 232 may be disposed within the distal end of first elongated tubular member 214, constrained in crimped configuration with a releasably secured annular lock 234. The distal end of second elongated tubular member 216 extends beyond annular lock 234 and has a radially projecting distal stop 236 that may engage annular lock 234. A third elongated tubular member 238 may also extend in fixed relation from housing 212, having a distal end with proximal stop 240 having an increased diameter with respect to third elongated tubular member 238 to engage annular lock 234 from the proximal direction. In this embodiment, proximal stop 240 may be a separate element affixed to third elongated tubular member 238 or may be integral. Third elongated tubular member 238 may have a fixed relation to housing 212 to maintain proximal stop 240 in a corresponding fixed position.

[00100] Housing 212 may also include fast deploy slider 242 that is operatively connected to first elongated tubular member 214 as described above. Intravascular device 210 may have a gripper 244, also similar to the embodiments described abo ve. Further, second elongated tubular member 216 may have one or more radiopaque markers, such as marker 246 to indicate proximal placement of stent 232, a reconstraining limit, or other suitable indications related to procedures to be performed with intravascular device 200.

[00101 ] Yet another embodiment of this disclosure is schematically depicted in FIG, 14 A, which is also similar to the intravascular device of FIG, 1, and similar elements have corresponding reference numerals (e.g., housing 312 of intravascular device 310 corresponds to housing 12 of intravascular device 10) unless otherwise noted. Here, intravascular device 300 may generally include a housing 312, a first elongated tubular member 314 extending from housing 312 and capable of axial motion with respect to housing 312 and a second elongated tubular member 316, also extending from housing 312 and capable of axial motion with respect to housing 314. A first actuator on housing 312 is configured as a rotary knob 318 may advance or withdraw first elongated tubular member 314. A second actuator configured slider 320 is coupled to second elongated tubular member 316 so that movement of slider 320 advances and withdraws second elongated tubular member 316. Knob 318 may also have a directional control assembly as described above to restrict the direction of movement allowed to first elongated tubular member 314 depending on whether slider 320 is engaged with the directional control, i.e., in its most distal position with respect to housing 312. In this embodiment, inner tubular member 322 extends from, and may be in fixed relation to, housing 312. Inner tubular member 322 terminates at its distal end in enlarged, tapered tip 324 and has a lumen 326 extending between its proximal and distal ends.

[00102 j Guide wire 328 may extend proxi mal i> from housing 312 though a suitable valve 330, such as a luer lock, that is in fluid communication with lumen 326 and guide wire 328 may also extend distally beyond tip 324. A stent 332 may be disposed within the distal end of first elongated tubular member 314, constrained in crimped configuration with a releasably secured annular lock 334. The distal end of second elongated tubular member 316 extends beyond annular lock 334 and has a radially projecting distal stop 336 that may engage annular lock 334. A third elongated tubular member 338 may also extend in fixed relation from housing 312, having a distal end with an increased diameter proximal stop 340 to engage annular lock 334 from the proximal direction. Third elongated tubular member 338 may have a fixed relation to housing 312 to maintain proximal stop 340 in a corresponding fixed position. [00103] As shown, annular lock 334 in this embodiment may be free floating and have a proximal portion sized to fit within the inner diameter of third elongated tubular member 338, In one aspect, the proximal portion of annular lock 334 may have sufficient distance so that some amount of annular lock 334 remains within the inner diameter of third elongated tubular member 338 when stent 332 undergoes a maximum amount of foreshortening to maintain a relationship between annular lock 334 and third elongated tubular member 338, Annular lock 334 may have an intermediate portion with an increased diameter that may be engaged by proximal stop 340, A distal portion of annular lock 334 may have sufficient diameter to engage stent 332 to secure the stent when the stent is crimped. Annular lock 334 may be monolithic or may be formed from as many separate elements as desired. Housing 312 may also include fast deploy slider 342 that is operativeiy connected to first elongated tubular member 314 as described above. Intravascular device 310 may have a gripper 344, also similar to the embodiments described above. Further, second elongated tubular member 316 may have one or more radiopaque markers, such as marker 346 to indicate proximal placement of stent 332, a reconstraining limit, or other suitable indications related to procedures to be performed with intravascular device 300.

100104] In the embodiment shown, housing 312 may include a reconstraining limit marker 350 at a suitable position adjacent the range of travel of fast deploy slider 342. This denotes the furthest retraction of first elongated tubular member 314 member that will still enable stent 332 to be reliably reconstrained. Reconstraining limit marker 350 may be provided as an alternative or a supplement to suitable radiopaque markers at the distal end of intravascular device 300, such as 346. Housing 312 may also feature a removable cover 352 to shield slider 320 and help prevent unintended manipulation during stent deployment. Tf repositioning stent 332 is desired, the operator first removes cover 352 to access slider 320 before commencing the reconstraining procedure. Slider 352 has an external surface 352a that is visible to the operator when cover 352 is mounted to housing 312.

[00105 J It should be noted that the slider (in various permutations as element 20, 120, 220 or 320), is preferably placed rearward of the knob 18, 118, 218, or 318 to induce the user (e.g., physician) to take the user's thumb off the knob (18, 118, 218, or 318) m order to use the slider (20, 120, 220 or 320). By inducing the user to use a sliding motion with slider (20, 120, 220 or 320), this encourages the user to use a similar sliding motion for the gnpper (44, 144, 244, 344) in order to control any buckling of the outer shaft (14, 114, 214, or 314). By virtue of how the slider is placed in relation to the knob and the gripper, this configurati on ensured correct usage of the reconstrainabiiity feature of the device. As well, the cover 352 is a safety feature in that it prevents accidental engagement of the slider (20, 120, 220 or 320). Although not shown, a geometric surface configuration in the form of a boss (positive or negative surface geometry) formed in the underside of the cover 352 can act as a stop member to prevent movement of the slider along the axis when the cover 352 is in place. While the preferred embodiment provides for a slider rearward of the knob, it is also within the scope of the claims that the slider can be positioned frontw ard of the knob.

[00106] Prior to performing a procedure with an intravascular device, a flushing step may be performed to expel air from the system in order to minimize the amount of air that may be introduced during the procedure. To facilitate this flushing step, the design of this disclosure permits flushing through a single port. As shown in FIG. 14 A, a distal portion of the inner tubular member 322 may have a plurality of perforations in fluid communication with lumen 326. Before intravascular device 310 is advanced over guide wire 328, a source of irrigation fluid, such as saline, may be connected to valve 330 to deliver the fluid into the proximal end of lumen 326. When the lumen is filled, air in the system will be displaced until fluid flows out of perforations 354 and flushes any voids between first elongated tubular member 314, stent 332 and inner tubular member 322, The operator may temporarily block the distal opening of lumen 326 to force the fluid through perforations 354. Further, as shown schematically in the end view of FIG. 15, the outer diameter of co ical distal tip 324 may correspond closely to the inner diameter of first elongated tubular member 314 so that a plurality of flutes 356 facilitate egress of fluid and air during the flushing step.

[00107] As discussed above, stents that may be deployed using intravascular deliver}' systems embodying the techniques of this disclosure may be self-expanding. An example of stent 32 employing a fully connected, helical geometry is schematically depicted in the side view of FIG. 16 in a crimped configuration with a length when the stent is crimped of Lc and an outer diameter when the stent is crimped of Dc. The configuration shown in FIG. 16 corresponds to a fully constrained state when disposed withm the distal portion of first elongated tubular member 14, for example. As shown, suitable features, such as eyelets or the like, may interface with corresponding recesses on annular lock 34 to secure in first state and release in second state stent 32. When first elongated tubular member 14 is fully withdrawn to deploy stent 32, it may expand within the patient's vessel, depending on the geometry of the vessel, up to the maximum non-constrained length, Lnc, and diameter, Dnc, according to its design parameters as schematically shown in the side view of FIG. 17. Upon expansion, the features of stent 32 are freed from annular lock 34, releasing it. The difference between the crimped length and the nominal deployed length is considered appreciable when greater than 10%. When deployed, if the distal end of the stent contacts the vessel wall when it expands, it may be stationary with respect to the vessel. Therefore, the proximal end of the stent may move distally to permit the stent to expand as it deploys.

[00108] As will be appreciated, any suitable design may be employed for annular locks to be used with the intravascular devices of this disclosure. The annular lock may interfaces with the stent in its crimped diameter, such that while the stent is crimped in the outer sheath, the stent and the annular lock move together or stay stationary together in a fixed relationship. The stent lock may be shorter, axiaily, than the stent. Generally, a stent lock may interface with a relatively short length (up to four or five mm) of the crimped stent. When the stent is not elastically deformed (constrained) in a reduced diameter that permits interfacing with the stent lock, and the temperature is above the transition temperature, the stent self-expands to its "memorized" form, and no longer interfaces with the stent lock and is released. A stent lock may be configured to mechanically interfere with a third elongated tubular member or proximal stop, to resist movement of the stent and annular lock assembly in the proximal direction.

100109] Similarly, the stent lock may be configured to mechanically interfere with the distal stop to resist distal movement of the stent and annular lock assembly. At l east a portion of the annular lock may be formed of a rigid material that maintains a generally cylindrical form while the designed torques and axial forces are applied to it. Some embodiments of an annular lock passively release the stent radially (i.e., the stent is not constrained in a reduced diameter by the annular lock). Some embodiments of a stent lock actively release the stent radially (i.e., without actuation, the stent lock also constrains a part of the stent in a reduced diameter). In some embodiments, the interface between the stent and the annular lock may be achieved through structural elements of the stent. For example, stent struts may extend radially some distance inwards and may contact a deformable material of the annular lock that conforms around the struts or other structural members to secure in first state and release in second state of the stent. In some embodiments of the deliver}' system, the annular lock is free to axially translate and rotate around the longitudinal axis of the tubular member on which it is earned, such as the second elongated tubular member 16.

[00110] In some embodiments of a delivery system, the length between the proximal stop and the distal stop may be variable and determined by the operator, but initially, as ready for use, the distance of possible axial travel of the annular lock may be greater than twenty (20) percent of the length of the stent when the entire stent is radially constrained in the outer member, to accommodate foreshortening, and in other embodiments is greater than twent -five (25) percent of the length. In some embodiments, the distance of possible axial travel of the annular lock between the two stops is variable and determined by the operator, but initially, as ready for use, may be greater than a pre-determined length corresponding to maximum expected

foreshortening.

1001 11 ] The preceding description has been presented with reference to presently disclosed embodiments of the invention. Workers skilled in the art and technology to which this invention pertains will appreciate that alterations and changes in the described structure may be practiced without meaningfully departing from the principal, spirit and scope of this invention. As understood by one skilled in the art, the drawings are not necessarily to scale. Accordingly, the foregoing description should not be read as pertaining only to the precise structures described and illustrated in the

accompanying drawings, but rather should be read consistent with and as support to the following claims which are to have their fullest and fair scope.

Claims

CLAIMS What is claimed is:
1. An intravascular device for deploying and reconstraining an expandable intraluminal device comprising:
a housing that extends along a longitudinal axis;
a first elongated tubular member extending from the housing and capable of axial motion relative to the housing:
a second elongated tubular member extending from the housing and capable of axial motion relative to the housing having a distal end with a radially projecting distal stop, wherein the second elongated tubular member is coaxially disposed within the first elongated tubular member;
an annular lock configured to secure in first state and release the intraluminal device in second state, wherein the annular lock is coaxially disposed over the second elongated tubular member and is coaxially disposed within the first tubular member and wherein the annular lock has an inner diameter that is less than an effective outer diameter of the distal stop;
a rotary knob on the housing coupled to the first elongated tubular member by a flexible loop member such that manipulation of the rotaiy knob axiallv moves the first elongated tubular member relative to the housing; and
a slider on the housing coupled to the flexible loop member.
2. The intrav ascular device of claim 1 , wherein the rotary knob provides a mechanical advantage such that the corresponding axial movement of the first elongated tubular member relative to the housing is less than the input movement.
3. The intravascular device of claim 1, wherein the annular lock comprises a plurality of recesses configured to capture elements of the expandable intraluminal device.
4. The intravascular device of claim 1 , further comprising a frictional actuator coaxially disposed over the first elongated tubular member distal of the housing.
5. The intravascular device of claim 1, further comprising an inner elongated tubular member coaxially disposed within the second elongated tubular member and extending from the housing past the distal stop, wherein the inner elongated tubular member comprises a lumen, a proximal port in fluid communication with the lumen and a distal portion having a plurality of perforations in fluid communication with the lumen.
6. The intravascular device of claim 5, wherein the intravascular device comprises a tapered distal tip having a plurality of flutes configured to allow egress of fluid supplied from the perforations of the inner elongated tubular member when the distal tip abuts a distal end of the first elongated tubular member.
7. The intravascular device of claim 1 , wherein the slider is disposed rearward of the first actuator closer to a user of the device.
8. The intravascular device of claim 1, further comprising a cover configured to hide the appearance of the slider when the cover is mounted to the housing in one mode and in another mode, being removable from the housing to allow" the slider to be visible.
9. The intravascular device of cl aim 8, wherein the cover comprises an external surface and an internal surface provided with a geometric configuration that prevents movement of the slider when the cover is mounted to the housing.
10. A reconstrainable stent deliver}7 system comprising:
a housing that extends along a longitudinal axis;
a first elongated tubular member extending from the housing and capable of axial motion relative to the housing;
a second elongated tubular member extending from the housing and capable of axial motion relative to the housing having a distal end with a radially projecting distal stop, wherein the second elongated tubular member is coaxially disposed withm the first elongated tubular member; an annular lock coaxially disposed over the second elongated tubular member and coaxially disposed within the first tubular member, wherein the annular lock has an inner diameter that is less than an effective outer diameter of the distal stop;
a self-expanding stent releasably secured to the annular lock;
a rotary knob on the housing coupled to the first elongated tubular member by a flexible loop member such that manipulation of the rotary knob axialiy moves the first elongated tubular member relative to the housing; and
a slider on the housing coupled to the flexible loop member.
1 1. A method for deploying and reconstraining an expandable intraluminal device comprising:
providing an intravascular device having a housing that extends along a longitudinal axis, a first elongated tubular member extending from the housing and capable of axial motion relative to the housing, a second elongated tubular member extending from the housing and capable of axial motion relative to the housing having a distal end with a radially projecting distal stop, wherein the second elongated tubular member is coaxially disposed within the first elongated tubular member, an anniilar lock releasably securing an expandable intraluminal device, wherein the annular lock is coaxially disposed over the second elongated tubular member and is coaxially disposed within the first tubular member and wherein the annular lock has an inner diameter that is less than an effective outer diameter of the distal stop, a rotary knob on the housing coupled to the first elongated tubular member by a flexible loop member and a slider on the housing coupled to the flexible loop member;
positioning a distal end of the intravascular device at a desired location within a patient's vasculature; and
manipulating the rotary knob to axialiy move the first elongated tubular member relative to the housing so that a portion of the expandable intraluminal device is exposed.
12. The method of claim 11, further comprising manipulating a slider on the housing coupled to the flexible loop member to axialiy move the first elongated tubular member proximally relative to the housing.
13. The method of claim 11 , further comprising manipulating a second actuator on the housing that is coupled to the second elongated tubular member to axially move the second elongated tubular member proximally relative to the housing until the distal stop engages the annular lock,
14. The method of claim 13, further comprising axially moving the first elongated tubular member distally relative to the housing to reconstrain the expandable intraluminal device.
15. The method of claim 13, further comprising applying force to the second actuator while axially moving the first elongated tubular member distally to keep the distal stop engaged with the annular lock.
16. The method of claim 15, further comprising accessing the second actuator by removing a cover disposed over the second actuator so that the second actuator is visible when the cover is removed.
17. The method of claim 13 , further comprising manipulating a frictional actuator coaxiaily disposed over the first elongated tubular member distal of the housing when axially moving the first elongated tubular member distally relative to the housing.
18. The method of claim 11, wherein the intravascular device further comprises an inner elongated tubular member coaxiaily disposed within the second elongated tubular member and extending from the housing past the distal stop, wherein the inner elongated tubular member comprises a lumen, a proximal port in fluid communication with the lumen and a distal portion having a plurality of perforations in fluid communication with the lumen, further comprising supplying irrigation fluid to the proximal port prior to positioning the distal end of the intravascular device at the desired location to cause the irrigation fluid to flow from the plurality of perforations.
19. The method of claim 18, wherein the intravascular device comprises a tapered distal tip having a plurality of flutes and wherein supplying irrigation fluid to the proximal port causes the irrigation fluid to be communicated through the perforations of the third elongated tubular member and flow out the flutes when the distal tip abuts a distal end of the first elongated tubular member.
PCT/US2016/015696 2015-01-31 2016-01-29 Reconstrainable stent delivery system with a slider and knob for actuation and method WO2016123503A1 (en)

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CN105832453A (en) 2016-08-10 application
CN105832452A (en) 2016-08-10 application
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CN205729576U (en) 2016-11-30 grant
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CN105832451A (en) 2016-08-10 application
WO2016123509A1 (en) 2016-08-04 application

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