Polymeric implant delivery system

• US 9,198,783 B2
• Filed: 09/07/2012
• Issued: 12/01/2015
• Est. Priority Date: 10/05/2009
• Status: Active Grant

• Current Assignee: Lyra Therapeutics, Inc.
• Original Assignee: 480 Biomedical, Inc.
• Inventors: Douk, Nareak, Busold, Rany, Core, Lee, Ho, Kicherl, Le, My, Robinson, Timothy Walter, Kostanski, Sarah, Shia, Benedict, Brightbill, Jerry
• Primary Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US13/606,962
• Publication Number:
  US 20130066295A1
• Time in Patent Office: 1,180 Days
• Field of Search: 606/108, 606/194, 606/200, 623/1.11, 623/1.12
• US Class Current: 1/1
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• 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 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

Delivery systems for a polymeric tubular implant, kits that include such delivery systems, and methods of treating patients by implanting tubular implants using the delivery systems. The delivery systems include an inner shaft, an expandable member slidably disposed about the inner shaft and configured to receive the tubular implant, and a tubular outer shaft disposed about the inner shaft.

Claims

1. A method of treating a patient, comprising:

engaging a tubular implant with a delivery catheter, said tubular implant moveable between an unstressed configuration characterized by a first diameter and a compressed configuration characterized by a second diameter less than the first diameter, and said delivery catheter comprising;

an inner shaft comprising a distal end configured for insertion into a patient and a proximal end configured to remain outside of the patient when the distal end is inserted into the patient, at least a portion of said inner shaft having a diameter less than said first diameter of said tubular implant;

a first expandable member slidably disposed about said inner shaft, said first expandable member comprising an open distal end having a first cross-sectional dimension greater than said first diameter of said tubular implant, said open distal end of said first expandable member configured for placement therein of at least a portion of the tubular implant when in said unstressed configuration, said first expandable member comprising a proximal end having a second cross-sectional dimension than less than said first diameter of said tubular implant;

a second expandable member affixed to said inner shaft, wherein said second expandable member is configured to be at least partially placed inside of the tubular implant and wherein said second expandable member is not a balloon; and

a tubular outer shaft slidably disposed about said inner shaft, said tubular outer shaft having a distal end and a proximal end, wherein a diameter of said tubular outer shaft at its distal end is less than said first cross-sectional dimension and greater than said second cross-sectional dimension;

wherein engaging the tubular implant with the delivery catheter includes moving the tubular implant from the unstressed configuration to the compressed configuration such that the tubular implant is removably disposed between the inner shaft and the tubular outer shaft and between the first and second expandable members, wherein each of the first and second expandable members is formed from a material selected from the group consisting of mesh material and woven material;

inserting at least a portion of the delivery catheter into a body of the patient; and

disengaging the tubular implant and the delivery catheter, thereby implanting the tubular implant within the body of the patient.

2. The method of claim 1, wherein engaging the tubular implant and the delivery catheter includes:

advancing the tubular implant over the inner shaft;

positioning at least a portion of the tubular implant within the open distal end of the first expandable member; and

compressing the first expandable member, thereby moving at least a portion of the tubular implant from the unstressed configuration to the compressed configuration.

3. The method of claim 2, wherein compressing the first expandable member includes advancing the tubular outer shaft in a distal direction over the first expandable member and the tubular implant.

4. The method of claim 3, further comprising retracting the first expandable member in a proximal direction away from the tubular implant after advancing the tubular outer shaft in a distal direction over the tubular implant.

5. The method of claim 2, further comprising a tubular middle shaft slidably disposed about said inner shaft and located between said inner shaft and said tubular outer shaft.

6. The method of claim 5, wherein the proximal end of said first expandable member is connected to said tubular middle shaft.

7. The method of claim 6, wherein said first expandable member is connected to said tubular middle shaft with an adhesive.

8. The method of claim 2, wherein said second expandable member comprises an open distal end having a cross-sectional dimension greater than a diameter of the tubular implant when the tubular implant is in an unstressed configuration, and wherein a proximal end of said second expandable member has a cross-sectional dimension less than a diameter of the tubular implant when the tubular implant is in an unstressed configuration.

9. The delivery system of claim 2, wherein (a) the inner shaft comprises an enlarged diameter portion located proximal to the distal end of the inner shaft;

and (b) advancing the tubular implant over the inner shaft includes positioning at least a portion of the tubular implant over the enlarged diameter portion.

10. The delivery system of claim 2, wherein (a) the inner shaft comprises a rententive cushion;

and (b) advancing the tubular implant over the inner shaft includes positioning at least a portion of the tubular implant over the retentive cushion.

11. The method of claim 10, wherein the cushion has a length, as measured along a long axis of the inner shaft, that is slightly less than a length of the tubular implant.

12. The method of claim 1, wherein a loading aid containing the tubular implant in an unstressed configuration is employed in the process of engaging the tubular implant with the delivery catheter.

13. The method of claim 12, wherein the loading aid comprises a generally elongate body having a lumen, which comprises a feature to limit migration of the tubular implant.

14. The method of claim 13, wherein the lumen comprises a portion having an inner diameter that is less than an outer diameter of the tubular implant contained within the loading aid.

15. The method of claim 1, wherein the implant is disengaged after fewer than 24 hours have elapsed from the engagement of the tubular implant with the catheter.

16. A method of treating a patient, comprising the steps of:

compressing a tubular implant within a delivery device, said tubular implant having a first diameter when in an unstressed configuration and a second diameter less than the first diameter when in a compressed configuration and said delivery device comprising;

an inner shaft comprising a distal end and a proximal end, wherein at least a portion of said inner shaft has a diameter less than the first diameter of the tubular implant and wherein the portion of the inner shaft of the delivery device having a diameter less than the first diameter of the tubular implant includes a compressible cushion;

a first expandable member slidably disposed about said inner shaft, said first expandable member comprising an open distal end having a cross-sectional dimension greater than the first diameter of the tubular implant and a proximal end having a cross-sectional dimension less than the first diameter of the tubular implant, wherein the first expandable members is formed from a material selected from the group consisting of mesh material and woven material;

a second expandable member affixed to said inner shaft, wherein said second expandable member is configured to be at least partially placed inside of the tubular implant and wherein said second expandable member is not a balloon; and

a tubular outer shaft slidably disposed about said inner shaft, said tubular outer shaft having a distal end and a proximal end and an inner diameter less than the first diameter of the tubular implant;

advancing the tubular implant over the distal end of the inner shaft, the second expandable member and the compressible cushion;

advancing first expandable member distally so that at least a portion of the tubular implant is located within the distal end of the first expandable member;

advancing the distal end of the tubular outer shaft over the first and second expandable members and the tubular implant, thereby compressing the tubular implant and loading it between the inner shaft and the outer shaft;

withdrawing the first expandable member such that no portion of the tubular implant is located within the first expandable member;

inserting the distal end of the inner shaft including the first expandable member and the tubular implant into a patient; and

withdrawing the distal end of the outer shaft to expose the tubular implant, thereby permitting the tubular implant to relax away from the inner tubular member.

17. The method of claim 16, wherein a loading aid containing the tubular implant in an unstressed configuration is employed in the process of compressing the tubular implant within the delivery device.

18. The method of claim 17, wherein the loading aid comprises a generally elongate body having a lumen, which comprises a feature to limit migration of the tubular implant.

19. The method of claim 18, wherein the lumen comprises a portion having an inner diameter that is less than an outer diameter of the tubular implant contained within the loading aid.

20. The method of claim 16, wherein the cushion has a length, as measured along a long axis of the inner shaft, that is slightly less than a length of the tubular implant.

21. A method of treating a patient, comprising:

engaging a tubular implant with a delivery catheter, said tubular implant moveable between an unstressed configuration characterized by a first diameter and a compressed configuration characterized by a second diameter less than the first diameter, and said delivery catheter comprising;

an inner shaft comprising a distal end configured for insertion into a patient and a proximal end configured to remain outside of the patient when the distal end is inserted into the patient, at least a portion of said inner shaft having a diameter less than said first diameter of said tubular implant;

a first expandable member slidably disposed about said inner shaft, said first expandable member comprising an open distal end having a first cross-sectional dimension greater than said first diameter of said tubular implant, said open distal end of said first expandable member configured for placement therein of at least a portion of the tubular implant when in said unstressed configuration, said first expandable member comprising a proximal end having a second cross-sectional dimension than less than said first diameter of said tubular implant;

a second expandable member affixed to said inner shaft, wherein said second expandable member is configured to be at least partially placed inside of the tubular implant and wherein said second expandable member is not a balloon; and

a tubular outer shaft slidably disposed about said inner shaft, said tubular outer shaft having a distal end and a proximal end, wherein a diameter of said tubular outer shaft at its distal end is less than said first cross-sectional dimension and greater than said second cross-sectional dimension;

wherein engaging the tubular implant with the delivery device includes moving the tubular implant from the unstressed configuration to the compressed configuration such that the tubular implant is removably disposed between the inner shaft and the tubular outer shaft and between the first and second expandable members, wherein each of the first and second expandable members is formed from a material selected from the group consisting of at least one of a mesh material and woven material;

inserting at least a portion of the delivery catheter into a body of the patient; and

disengaging the tubular implant and the delivery catheter, thereby implanting the tubular implant within the body of the patient.