Unidirectional delivery system

• US 7,691,139 B2
• Filed: 12/27/2005
• Issued: 04/06/2010
• Est. Priority Date: 12/28/2004
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Baker, Deborah A., Purdy, James D., Parker, Fred T.
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): Severson; Ryan J
• Application Number:
  US11/318,690
• Publication Number:
  US 20060190069A1
• Time in Patent Office: 1,561 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.16, 623/1.25, 623/1.27, 623/2.11, 606/108, 606/194, 604/164.01, 604/164.12, 604/264
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod

Abstract

A tubular prosthesis delivery system has an inner tubular member having a distal end including a prosthesis-carrying portion and a proximal end intended to remain outside the patient. An outer tubular member has a distal end spaced from the prosthesis-carrying portion of the inner member. A coupling member couples the inner and outer tubular members to each other in fixed relationship generally at a location intended to remain outside the patient. An intermediate tubular member located between the inner and outer tubular members has a distal end adapted to cover the tubular prosthesis and a proximal end that projects proximally beyond the proximal ends of both the inner and outer tubular members. The proximally projecting end of the intermediate tubular member is longitudinally movable with respect to the coupled inner and outer tubular members by a distance sufficient to retract the intermediate tubular member distal end from any position covering the prosthesis carried by the inner member.

Claims

1. A delivery system for placement of a tubular prosthesis at a selected location within a lumen of a patient, the delivery system comprising:

an inner tubular member having a proximal end and a distal end,

an outer tubular member having a proximal end and having a distal end spaced longitudinally some distance from the inner tubular member distal end so that a projecting portion of the inner tubular member projects distally beyond the outer tubular member distal end, the projecting portion being adapted to carry a tubular prosthesis,

an intermediate tubular member having a proximal end projecting proximally beyond the proximal end of both the inner and outer tubular members, having a distal end adapted to cover at least the tubular prosthesis carrying portion of the inner tubular member, the intermediate tubular member having a longitudinal slot, and

a coupling member comprising a protection extending outwardly from proximal end of the inner tubular member and extending through the longitudinal slot coupling the inner and outer tubular members to each other in permanent fixed relationship, the outwardly extending projection having an outer end coupled to the interior of the outer tubular member,

the coupling member being longitudinally shorter than the longitudinal slot so that the intermediate tubular member is longitudinally movable with respect to the inner and outer tubular members, the longitudinal slot being sufficiently long to permit movement of the intermediate tubular member by a distance sufficient to retract the intermediate tubular member distal end from any position covering the tubular prosthesis carrying portion of the inner tubular member.

2. The delivery system of claim 1 wherein the longitudinal slot is situated in a proximal portion of the intermediate tubular member intended to remain outside the patient.

3. The delivery system of claim 1, wherein the intermediate tubular member includes a pair of said longitudinal slots and the coupling member comprises a pair of outwardly extending projections, wherein the outwardly extending projections are sufficiently flexible to permit inward radial collapse of the outer ends during initial assembly.

4. The delivery system of claim 3 wherein the outer tubular member further comprises a plurality of recesses sized to receive the outer ends of the outwardly extending projections.

5. The delivery system of claim 4 wherein the outer ends of the outwardly extending projections are secured in the recesses of the outer tubular member.

6. The delivery system of claim 1 wherein the outer tubular member comprises a proximal portion in the form of a handle including at least one port for admitting fluids into the interior of one or more of the tubular members.

7. The delivery system of claim 6 further comprising at least one release mechanism movably located at the proximal end of the outer tubular member to regulate the release of any tubular prosthesis.

8. The delivery system of claim 1, wherein the proximal end of the intermediate tubular member is enlarged to form a handle defining the most proximal portion of the system, wherein the handle is adapted to move proximally from the proximal end of the outer tubular member by a distance sufficient to retract the intermediate tubular member distal end from any position covering the tubular prosthesis carrying portion of the inner tubular member.

17. The delivery system of claims 1 or 15, wherein the outer tubular member is coaxially disposed around the intermediate tubular member, surrounding the longitudinal slot of the intermediate tubular member so that the proximal end of the inner tubular member is located distally beyond the proximal end of both the intermediate and outer tubular members.

9. A method of placement of a tubular prosthesis at a selected location within a lumen of a patient, the method comprising the steps of:

providing a tubular prosthesis on a distal portion of an inner tubular member having a proximal end intended to remain outside said patient and a distal end,

locating coaxially an outer tubular member having a proximal end and a distal end so that the outer tubular member distal end is spaced longitudinally some distance from the inner tubular member distal end so that a projecting portion of the inner tubular member and the tubular prosthesis projects distally beyond the outer tubular member distal end,

locating an intermediate tubular member having a longitudinal slot between the inner and outer tubular members so that a distal end of the intermediate tubular member covers the prosthesis carried by the inner tubular member projecting portion and so that a proximal end of the intermediate tubular member projects proximally beyond the proximal end of both the inner and outer tubular members,

coupling the inner and outer tubular members to each other in permanent fixed relationship by a coupling member extending through the longitudinal slot in the intermediate tubular member, the coupling member comprising a projecting end extending outwardly from the proximal end of the inner tubular member through the longitudinal slot, wherein the outwardly project end is coupled to the interior of the outer tubular member,

positioning the prosthesis at a desired location within a patient, and

moving the proximal end of the intermediate tubular member with respect to the coupled inner and outer tubular members by a distance sufficient to retract the intermediate tubular member distal end from any position covering the prosthesis.

10. The method of claim 9 wherein the coupling of the inner and outer tubular members comprises the steps of:

providing a flexible portion of the inner tubular member with the outwardly projecting end,

displacing the flexible portion inward to permit the outwardly projecting end to pass within the intermediate tubular member until the outwardly projecting end is aligned with the longitudinal slot, and

allowing the flexible portion to flex outward through the longitudinal slot until the outwardly projecting end is received in a recess in the outer tubular member.

11. The method of claim 9 further comprising the steps of:

providing a latch to couple a proximal portion of the intermediate tubular member to the proximal end of the outer tubular member, and

releasing the latch prior to said step of moving the proximal end of the intermediate tubular member with respect to the coupled inner and outer tubular members.

12. The method of claim 9 or 11 further comprising the steps of:

providing at least one trigger wire extending from the prosthesis to the proximal end of the outer tubular member,

providing a trigger wire puller between the proximal end of the outer tubular member and the proximal end of the intermediate tubular member, and

moving the trigger wire puller proximally only after said step of moving the proximal end of the intermediate tubular member with respect to the coupled inner and outer tubular members.

13. The method of claim 12 further comprising the steps of:

providing a latch to couple the trigger wire puller to the proximal end of the outer tubular member, and

releasing the trigger wire latch only after said step of moving the proximal end of the intermediate tubular member with respect to the coupled inner and outer tubular members.

14. The method of claim 9 further comprising the steps of:

providing at least one port adjacent the proximal end of the outer tubular member,

coupling the at least one port to a source of fluid, and

causing a volume of fluid to flow from the source into one of the tubular members to assist in radial distension of the prosthesis.

15. A delivery system for placement of a tubular prosthesis at a selected location within a lumen of a patient, the delivery system comprising:

an inner tubular member having a proximal end and a distal end;

an outer tubular member having a proximal end spaced proximally beyond the inner tubular member proximal end and having a distal end spaced longitudinally some distance from the inner tubular member distal end so that a projecting portion of the inner tubular member projects distally beyond the outer tubular member distal end, the projecting portion being adapted to carry a tubular prosthesis;

an intermediate tubular member having an enlarged proximal end projecting proximally beyond the proximal end of both the inner and outer tubular members, and having a distal end adapted to cover at least the tubular prosthesis carrying portion of the inner tubular member, the intermediate tubular member having a longitudinal slot located distal to the proximal end of the outer tubular member, each of the tubular members having a coaxial relationship with one another; and

a coupling member extending from the proximal end of the inner tubular member and through the longitudinal slot, to the interior of the outer tubular member, coupling the inner and outer tubular members in a permanent fixed relationship,

the coupling member being longitudinally shorter than the longitudinal slot so that the enlarged proximal end of the intermediate tubular member is longitudinally movable with respect to the inner and outer tubular members, the longitudinal slot being dimensioned to permit movement of the intermediate tubular member by a distance sufficient to retract the intermediate tubular member distal end from any position covering the tubular prosthesis carrying portion of the inner tubular member.

16. The delivery system of claim 15, wherein the enlarged proximal end of the intermediate tubular member is movable between a first position and a second position relative to the coupled outer and inner tubular members, wherein at the first position the enlarged proximal end is adjacent the distal end of the outer tubular member, and at the second position the enlarged proximal end is longitudinally spaced from the distal end of the outer tubular member by a distance at least the length of the longitudinal slot.

18. The delivery system of claim 15, wherein the enlarged proximal end of the intermediate tubular member further comprises a latch adapted to releasably couple said enlarged proximal end to a portion of the outer tubular member, the latch being releasable to permit movement of said enlarged proximal end relative to the coupled inner and outer tubular members.

19. The delivery system of claim 15 further comprising a handle on the outer tubular member proximal end including at least one seal contacting the intermediate tubular member to inhibit fluid leakage, and at least one port leading to the interior of the handle providing fluid access to the interior of at least one of the tubular members.

20. The delivery system of claim 6 or 19 wherein the handle further comprises a port leading to the interior of the handle to provide fluid access to the interior of the intermediate tubular member through said longitudinal slot.

21. The delivery system of claim 15 further comprising one or more pullers situated between the enlarged proximal end of the intermediate tubular member and the distal end of the outer tubular member, and one or more trigger wires corresponding to and coupled to the one or more pullers and extending through the longitudinal slot of the intermediate tubular member in order to releasably couple to one or more portions of said tubular prosthesis, the one or more pullers adapted to move proximally from the distal end of the outer tubular member after movement of the enlarged proximal end such that the one or more trigger wires is released from the tubular prosthesis, wherein the one or more pullers comprises a latch adapted to prevent premature release of the corresponding one or more trigger wires.