Prosthesis delivery

• US 6,656,212 B2
• Filed: 12/29/2000
• Issued: 12/02/2003
• Est. Priority Date: 05/20/1993
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Ravenscroft, Adrian C., Roberts, George T.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): STEWART, ALVIN J
• Application Number:
  US09/751,084
• Publication Number:
  US 20010001833A1
• Time in Patent Office: 1,068 Days
• Field of Search: 623/1.11, 606/194, 606/198, 606/108, 606/195, 606/193, 606/192, 606/191, 604/93.01, 604/96.01
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

This invention provides smooth delivery and accurate positioning of prostheses in the body. In embodiments, systems are provided that include elongate members extending generally along the axis of a supporting catheter to a free ends. The elongate members extend through openings in the prosthesis to maintain the position of the prosthesis on the catheter. The prosthesis can be released from the catheter by relative axial motion of the catheter and the elongate members such that the free ends are removed from the openings in the prosthesis. In embodiments, the elongate members hold the distal end of a self-expanding stent at a desired axial location and in radial compaction as a restraining sheath is withdrawn. The friction between the sheath and stent puts the stent under tension, which reduces the radial force on the sheath wall, allowing smoother retraction. Proximal portions of the stent radially expand and axially shorten. The distal end, however, is maintained at the desired axial location and released from the catheter to contact the body lumen wall without substantial axial shortening.

Claims

1. A catheter for deploying a prosthesis in a distal deployment location inside a body lumen from a proximal access location outside the body lumen, the prosthesis having a proximal end, a distal end, and a radially compressed configuration, the catheter comprising a portion having a longitudinal axis and adapted to be positioned coaxially with the compressed prosthesis, the portion having a first section disposed radially within an envelope defined by the compressed prosthesis and having at least one elongated member extending from the first section at a non-perpendicular angle to the longitudinal axis of the catheter, the elongated member extending along a straight, unbent path between the catheter and an end of the member, the member adapted to releasably engage a distal portion of the compressed prosthesis at or near the distal end of the prosthesis and to maintain engagement of the distal portion during deployment of the proximal end of the prosthesis.

2. A prosthesis delivery system comprising the catheter of claim 1 and the prosthesis in the compressed configuration coaxially mounted on the catheter.

3. The prosthesis delivery system of claim 2 wherein the member is adapted to maintain engagement the prosthesis distal portion in one of:

a predetermined axial location, the compressed configuration, or a combination thereof, during deployment of the proximal end of the prosthesis.

4. The prosthesis delivery system of claim 2 wherein the distal portion of the prosthesis engaged by the member is releasable from the catheter by relative axial motion between the member and the prosthesis.

5. The prosthesis delivery system of claim 2 further comprising an axially retractable sheath for maintaining the proximal end of the prosthesis in the compressed configuration during introduction of the prosthesis into the body lumen.

6. The catheter of claim 1, wherein the at least one member is adapted to exert a force comprising at least one non-frictional axial force component on the distal portion of the compressed prosthesis.

7. A prosthesis delivery system comprising the catheter of claim 6 and the prosthesis in the compressed configuration coaxially mounted on the catheter.

8. The prosthesis delivery system of claim 7 wherein the distal portion of the prosthesis engaged by the member is releasable from the catheter by relative axial motion between the member and the prosthesis.

9. The prosthesis delivery system of claim 7 further comprising an axially retractable sheath for maintaining the proximal end of the prosthesis in the compressed configuration during introduction of the prosthesis into the body lumen.

10. The catheter of claim 6, wherein the at least one non-rictional axial force component is a distally-directed force.

11. A prosthesis delivery system for deploying a prosthesis in a distal cation inside a body lumen from a proximal location outside the body lumen, the system comprising:

a catheter having a longitudinal axis and comprising at least one elongated member extended from the catheter at a non-perpendicular angle to the axis along a straight, unbent path between the catheter and an end of the member;

a prosthesis having a distal end, a proximal end, and a radially compressed configuration, the prosthesis mounted on the catheter in the compressed configuration.

12. The catheter of claim 11 wherein the at least one elongated member comprises a plurality of elongated members and the plurality of elongated members are distributed along a circumference of the catheter in a single axial location.

13. The catheter of claim 11 wherein the at least one elongated member is attached to the catheter by one of:

an epoxy, a radiopaque band, a heat shrink tube, or a combination thereof.

14. The prosthesis delivery system of claim 11 wherein the at least one elongated member is adapted to releasably engage a distal portion of the compressed prosthesis near the distal end of the prosthesis and to maintain engagement of the distal portion during deployment of the proximal end of the prosthesis.

15. The prosthesis delivery system of claim 11 wherein the at least one elongated member is adapted to maintain engagement of the prosthesis distal portion in one of:

a predetermined axial location, the compressed configuration, or a combination thereof, during deployment of the proximal end of the prosthesis.

16. The prosthesis delivery system of claim 11 wherein the distal portion of the prosthesis engaged by the member is releasable from the catheter by relative axial motion between the member and the prosthesis.

17. The prosthesis delivery system of claim 11 further comprising a axially retractable sheath for maintaining the proximal end of the prosthesis is in the compressed configuration during introduction of the prosthesis into the body lumen.

18. A prosthesis delivery system for deploying a prosthesis in a distal location within a body lumen from a proximal location outside the body lumen, the system comprising:

the prosthesis having a proximal end, a distal end, and a radially compressed configuration; and

a catheter having a longitudinal axis and comprising at least one elongated member extended from the catheter at a non-perpendicular angle to the axis along a straight, unbent path between the catheter and an end of the member and adapted to engage the distal end of the prosthesis.

19. The prosthesis delivery system of claim 18 wherein the at least one elongated member comprises a plurality of elongated members and the plurality of elongated members are distributed along a circumference of the catheter in a single axial location.

20. The prosthesis delivery system of claim 18 wherein the at least one elongated member is adapted to maintain engagement of the prosthesis distal portion in one of:

a predetermined axial location, the radial compact state, or a combination thereof, during deployment of the proximal end of the prosthesis.

21. The prosthesis delivery system of claim 18 wherein the distal portion of the prosthesis engaged by the at least one elongated member is releasable from the catheter by relative axial motion between the member and the prosthesis.

22. The prosthesis delivery system of claim 18 further comprising an axially retractable sheath for maintaining the proximal end of the prosthesis in the compressed configuration during introduction of the prosthesis into the body lumen.

23. A prosthesis delivery system for deploying a prosthesis in a distal location within a body lumen from a proximal location outside the body lumen, the system comprising:

the prosthesis having a proximal end, a distal end, and a radially compressed configuration; and

a catheter having a longitudinal axis and comprising at least one elongated member extended from the catheter at an angle to the axis along a straight, unbent oath between the catheter and an end of the member and adapted to engage the distal end of the prosthesis, the at least one elongated member attached to the catheter by one of;

an epoxy, a radiopaque band, a heat shrink tube, or a combination thereof.

24. A method for loading a prosthesis delivery system comprising a compressed prosthesis having a proximal end and a distal end, a catheter on which the prosthesis is mounted coaxially on a first portion thereof, and an outer sheath overlying the compressed prosthesis and the catheter, the catheter having at least one member that releasably engages a distal portion of the prosthesis at or near the prosthesis distal end, the member (i) extending from a section of the first portion located radially within an envelope defined by the prosthesis, (ii) extending from the catheter at a non-perpendicular angle to the axis along a straight, unbent path between the catheter and an end of the member, or (iii) a combination thereof, the method comprising:

positioning a portion of the catheter coaxially within the compressed prosthesis, including releasably engaging a portion of the prosthesis distal end with the at least one member, and

loading the compressed prosthesis and the catheter within the outer sheath.

25. A method for deploying a prosthesis in a distal deployment location inside a body lumen from a proximal access location outside the body lumen, the method comprising:

a) introducing a pre-loaded prosthesis delivery system into the body lumen, the prosthesis delivery system comprising a compressed prosthesis having a proximal end and a distal end, a catheter on which the prosthesis is mounted coaxially on a first portion thereof, and an outer sheath overlying the compressed prosthesis and the catheter, the catheter having at least one elongated member that releasably engages a distal portion of the prosthesis at or near the prosthesis distal end, the member (i) extending from a section of the first portion located radially within an envelope defined by the prosthesis, (ii) extending from the catheter at a non-perpendicular angle to the axis along a straight, unbent path between the catheter and an end of the member, or (iii) a combination thereof; and

b) navigating the prosthesis delivery system to a desired location for deploying the prosthesis;

c) retracting the outer sheath to deploy a proximal portion of the prosthesis into the desired location while the catheter member maintains the distal end of the prosthesis (i) compressed, (ii) in a predetermined axial position, or (iii) a combination thereof; and

d) releasing and deploying the distal end of the prosthesis.

26. The method of claim 25 wherein step (d) comprises moving the catheter member proximally relative to the prosthesis.

27. A method for deploying a prosthesis in a distal deployment location inside a body lumen from a proximal access location outside the body lumen, the method comprising:

a) introducing a pre-loaded prosthesis delivery system into the body lumen, the prosthesis delivery system comprising a compressed prosthesis having a proximal end and a distal end, a catheter on which the prosthesis is mounted coaxially on a first portion thereof, and an outer sheath overlying the compressed prosthesis and the catheter, the catheter having at least one elongated member that releasably engages a distal portion of the prosthesis at or near the prosthesis distal end, the member (i) extending from a section of the first portion located radially within an envelope defined by the prosthesis, (ii) extending from the catheter at an angle to the axis along a straight, unbent path between the catheter and an end of the member, or (iii) a combination thereof; and

b) navigating the prosthesis delivery system to a desired location for deploying the prosthesis;

c) retracting the outer sheath to deploy a proximal portion of the prosthesis into the desired location while the catheter member maintains the distal end of the prosthesis (i) compressed, (ii) in a predetermined axial position, or (iii) a combination thereof; and

d) releasing and deploying the distal end of the prosthesis in a first lumen in a position near an intersection of the first lumen with a second lumen wherein maintaining engagement of the distal end during deployment of the proximal end prevents the proximal end from being deployed in a position in which the proximal end protrudes from the first lumen into the second lumen.

28. The method of claim 27 wherein the first lumen is a bile duct and the second lumen is a duodenum.