Apparatus and methods for deployment of multiple custom-length prostheses (III)

• US 10,219,923 B2
• Filed: 11/29/2007
• Issued: 03/05/2019
• Est. Priority Date: 06/08/2005
• Status: Active Grant

• Current Assignee: JW Medical Systems Ltd
• Original Assignee: JW Medical Systems Ltd
• Inventors: Hammersmark, Dan Jeffery, Kao, Stephen, Welk, Craig, Acosta, Pablo, Karatt, Joseph
• Primary Examiner(s): Stransky, Katrina M
• Assistant Examiner(s): Mendoza, Michael G
• Application Number:
  US11/947,677
• Publication Number:
  US 20080071345A1
• Time in Patent Office: 4,114 Days
• Field of Search: 606200, 623 111, 604507
• CPC Class Codes: A61B 2017/00309 Cut-outs or slits
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2250/0007 for adjusting length
• CPC Class Codes: A61F 2250/0032 differing in radiographic density
• CPC Class Codes: A61F 2250/007 O-rings
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

Apparatus for delivering stents to body lumens include one or more tubular prostheses carried at the distal end of a catheter shaft, a sheath slidably disposed over the prostheses, and a guidewire tube extending from within the sheath to the exterior of the sheath through an exit port in a sidewall thereof. A guidewire extends slidably through the guidewire tube. The sheath can be moved relative to the catheter shaft and the guidewire tube to expose the prostheses for deployment. Methods of delivering stents are also provided.

Claims

1. An apparatus for constraining a portion of an expandable member within a target vessel of a patient, comprising:

a flexible catheter having an outer sheath slidably disposed over an inner shaft;

an expandable member coupled to the inner shaft;

a cylindrical constraining member positioned near or at a distal end of the outer sheath, wherein the cylindrical constraining member comprises;

a distal member section having no cut-outs such that a radial strength of the distal member section is sufficient to restrain the expandable member from expanding;

a first set of cut-outs adjacent and proximal to the distal member section;

a central member section, adjacent and proximal to the first set of cut-outs, having a second set of cut-outs with a repeating set of cut-out pairs, wherein a first cut-out pair comprises two connecting struts positioned along a first transverse axis and a second adjacent cut-out pair comprises two additional connecting struts positioned along a second transverse axis, wherein the second transverse axis is offset from the first transverse axis, and wherein the cylindrical constraining member is most axially flexible about the first and second transverse axes relative to a remainder of the cylindrical constraining member;

a third and fourth set of cut-outs adjacent and proximal to the central member section; and

a proximal member section, adjacent and proximal to the fourth set of cut-outs, comprising a proximal end connected to the central member section via axially-aligned struts forming a fifth set of cut-outs that are circumferentially aligned, wherein a valve member is connected to the proximal member section at the axially-aligned struts; and

a plurality of tubular prostheses releasably carried over the expandable member, wherein the outer sheath is disposed over the prostheses such that retraction of the outer sheath relative to the inner shaft exposes a distal portion of the expandable member for expansion while a proximal portion of the expandable member is restrained from expanding by the constraining member, wherein the constraining member has a length at least as long as one of the tubular prostheses.

2. The apparatus of claim 1 wherein a selected number of the plurality of tubular prostheses are expandable by the expandable member when exposed distally of the constraining member.

3. The apparatus of claim 1 wherein the expandable member comprises an inflatable balloon.

4. The apparatus of claim 1 wherein the constraining member is comprised of a metallic, polymeric, or super-elastic alloy.

5. The apparatus of claim 1 wherein the constraining member comprises a covering upon its exterior surface.

6. The apparatus of claim 1 wherein the first set of cut-outs have a linear or slot-like shape.

7. The apparatus of claim 6 wherein the third set of cut-outs are circumferentially staggered from the first set of cut-outs.

8. The apparatus of claim 7 wherein the fourth set of cut-outs are rectangular or oval-shaped and are relatively narrower and shorter than the third set of cut-outs and wherein the fourth set is proximal to the third set of cut-outs.

9. The apparatus of claim 6, wherein the cylindrical constraining member has a length equal to a length of one tubular prosthesis.

10. The apparatus of claim 1 wherein the axially-aligned struts are hourglass-shaped such that the fifth set of cut-outs are hexagonally-shaped.

11. The apparatus of claim 1 wherein the constraining member is cut or stamped from a sheet of material.

12. An apparatus for constraining a portion of an expandable member within a target vessel of a patient, comprising:

a constraining member positioned near or at a distal end of an outer sheath slidably disposed over an expandable member which is coupled to an inner shaft of a catheter; and

,

a plurality of tubular prostheses releasably carried over the expandable member, wherein the outer sheath is disposed over the prostheses and is axially movable relative thereto,

wherein the constraining member comprises;

a first set of cut-outs;

a central member section, adjacent and proximal to the first set of cut-outs, having a second set of cut-outs with a repeating set of cut-out pairs, wherein a first cut-out pair comprises two transverse slot-like cut-outs circumferentially aligned and separated by two connecting struts along a first transverse axis, wherein two adjacent connecting struts separate an adjacent cut-out pair along a second transverse axis, wherein the second transverse axis is offset from the first transverse axis, and wherein the cylindrical constraining member is most axially flexible about the first and second transverse axes relative to a remainder of the cylindrical constraining member;

a third and fourth set of cut-outs adjacent and proximal to the central member section;

a proximal member section, adjacent and proximal to the fourth set of cut-outs, comprising a proximal end connected to the central member section via axially-aligned struts forming a fifth set of cut-outs that are circumferentially aligned, wherein a valve member is connected to the proximal member section at the axially-aligned struts, and

wherein the valve member is configured to engage at least one of the tubular prostheses when disposed within the constraining member.

13. The apparatus of claim 12 wherein a selected number of the plurality of tubular prostheses are expandable by the expandable member when exposed distally of the constraining member.

14. The apparatus of claim 12 wherein the expandable member comprises an inflatable balloon.

15. The apparatus of claim 12 wherein the constraining member is comprised of a metallic, polymeric, or super-elastic alloy.

16. The apparatus of claim 12 wherein the constraining member is cut or stamped from a sheet of material.

17. An apparatus for deploying at least one tubular prosthesis within a vessel, comprising:

a flexible catheter having an outer sheath slidably disposed over an inner shaft;

a plurality of tubular prostheses slidably positioned upon the inner shaft and deployable therefrom prostheses; and

a valve member positioned within a garage member mounted to the outer sheath and configured to engage at least one of the tubular prosthesis such that the valve member restricts sliding movement of the tubular prosthesis distally relative to the outer sheath,

wherein the garage member comprises a cylindrical constraining member comprises;

a distal member section having no cut-outs such that a radial strength of the distal member section is sufficient to restrain the expandable member from expanding;

a first set of cut-outs adjacent and proximal to the distal member section;

a central member section, adjacent and proximal to the first set of cut-outs, having a second set of cut-outs with a repeating set of cut-out pairs, wherein one cut-out pair comprises two transverse slot-like cut-outs circumferentially aligned and separated by two connecting struts along a first transverse axis, wherein two adjacent connecting struts separating an adjacent cut-out pair a second transverse axis, wherein the second transverse axis is offset from the first transverse axis, and wherein the cylindrical constraining member is most axially flexible about the first and second transverse axes relative to a remainder of the cylindrical constraining member;

a third and fourth set of cut-outs adjacent and proximal to the central member section; and

a proximal member section, adjacent and proximal to the fourth set of cut-outs, comprising a proximal end connected to the central member section via axially-aligned struts forming a fifth set of cut-outs that are circumferentially aligned, wherein a valve member is connected to the proximal member section at the axially-aligned struts.

18. The apparatus of claim 17 wherein engagement of the valve member to the at least one of the tubular prosthesis separates a selected number of tubular prostheses to be deployed from a remainder of the tubular prostheses remaining within the outer sheath to be retracted proximally with the outer sheath.

19. The apparatus of claim 17 wherein the axially-aligned struts are hourglass-shaped such that the fifth set of cut-outs are hexagonally-shaped.

20. The apparatus of claim 17 wherein the valve member comprises an inwardly extending ring-shaped flange configured to frictionally engage the at least one of the tubular prosthesis.

21. The apparatus of claim 17 wherein the valve member exerts an engagement force of between 0.5 to 5 lbs on the at least one of the tubular prosthesis.

22. The apparatus of claim 17 wherein the valve member comprises a polymeric or metallic material.

23. The apparatus of claim 17 wherein the valve member comprises a cross-sectional shape selected from the group consisting of circles, triangles, and trapezoids.

24. The apparatus of claim 17 wherein the constraining member is cut or stamped from a sheet of material.

25. A method of deploying at least one tubular prosthesis within a vessel, comprising:

sliding a plurality of tubular prostheses upon an inner shaft of a catheter;

exposing a selected number of prostheses for deployment into the vessel;

engaging at least one of the tubular prosthesis proximal to the selected number via a valve member positioned within a garage member mounted to the outer sheath along a length of the tubular prosthesis, wherein the garage member comprises a cylindrical constraining member comprises;

a distal member section having no cut-outs such that a radial strength of the distal member section is sufficient to restrain the expandable member from expanding;

a first set of cut-outs adjacent and proximal to the distal member section;

a central member section, adjacent and proximal to the first set of cut-outs, having a second set of cut-outs with a repeating set of cut-out pairs, wherein one cut-out pair comprises two transverse slot-like cut-outs circumferentially aligned and separated by two connecting struts along a first transverse axis, wherein two adjacent connecting struts separate an adjacent cut-out pair along a second transverse axis, wherein the second transverse axis is offset from the first transverse axis, and wherein the cylindrical constraining member is most axially flexible about the first and second transverse axes relative to a remainder of the cylindrical constraining member;

a third and fourth set of cut-outs adjacent and proximal to the central member section; and

a proximal member section, adjacent and proximal to the fourth set of cut-outs, comprising a proximal end connected to the central member section via axially-aligned struts forming a fifth set of cut-outs that are circumferentially aligned, wherein a valve member is connected to the proximal member section at the axially-aligned struts; and

retracting the outer sheath while engaging the at least one of the tubular prosthesis with the valve member such that a remainder of the tubular prosthesis within the outer sheath is spaced apart from the selected number for deployment.

26. The method of claim 25 wherein the valve member engages the tubular prosthesis along ¼

to ¾

of a length of the tubular prosthesis.

27. The method of claim 25 wherein the valve member engages the at least one of the tubular prosthesis with an engagement force of between 0.5 to 5 lbs.

28. The method of claim 25 further comprising inflating an expandable member attached to the inner shaft to deploy the selected number of tubular prosthesis.

29. The method of claim 25 wherein the constraining member is cut or stamped from a sheet of material.