Systems and methods for delivering stent grafts

• US 10,278,851 B2
• Filed: 10/03/2017
• Issued: 05/07/2019
• Est. Priority Date: 10/07/2016
• Status: Active Grant

• Current Assignee: PQ Bypass, Inc.
• Original Assignee: PQ Bypass, Inc.
• Inventors: Reis, Gene, Jambunathan, Kumar, Tyler, Steven
• Primary Examiner(s): Severson, Ryan J.
• Assistant Examiner(s): Knauss, Christian D
• Application Number:
  US15/723,933
• Publication Number:
  US 20180098869A1
• Time in Patent Office: 581 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/962 having an outer sleeve
• 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 2002/9623 the sleeve being reinforced

Abstract

A delivery catheter comprises an inner shaft and an outer sheath. A stent-graft is held on a region of the inner shaft. An enlarged diameter distal region of the outer sheath constrains the stent-graft. Its retraction allows the stent-graft to deploy. A finger wheel on a handle is used to retract the outer sheath and is coupled to a sliding block with cable(s). The sliding block is coupled to the outer sheath and is held within a sliding track. The wheel can be actuated to tension the cable(s) and deform latch(es) coupled to sliding block, freeing them from slot(s) in the sliding track and allowing retraction of the sliding block and the outer sheath. A reinforcement sleeve is coupled to a smaller diameter proximal region of the outer sheath. A gap between the outer sheath distal region and the reinforcement sleeve allows the distal outer shaft region to be retracted.

Claims

1. A catheter apparatus for delivering an implant, the catheter apparatus comprising:

an inner shaft having a proximal portion, a distal portion, and an implant holding region at the distal portion;

an outer sheath disposed at least over the implant holding region of the inner shaft, the outer sheath being configured to be proximally retracted to expose an implant placed in the implant holding region to allow the implant to be deployed, and the retractable outer sheath having a proximal end and a distal end;

at least one retractable latch coupled to the proximal end of the outer sheath and configured to resist retraction of the outer sheath;

at least one cable coupled to the at least one retractable latch; and

a handle body enclosing the proximal portion of the inner shaft and the proximal end of the outer shaft,

wherein the latch mechanism is configured to be released upon tensioning of the at least one cable over a threshold force so that the proximal retraction of the at least one cable over the threshold force proximally retracts the at least one retractable latch and the outer sheath, and

wherein the handle body comprises an inner track, wherein the at least one retractable latch is configured to releasably couple to the inner track of the handle body to resist proximal retraction, and wherein the tensioning of the at least one cable over the threshold force releases the at least one retractable latch from the inner track of the handle body.

2. The catheter apparatus of claim 1, wherein the at least one retractable latch is biased to push outwardly against the inner track of the handle body to provide friction to resist proximal retraction, and wherein the tensioning of the at least one cable over the threshold force changes a configuration of the at least one retractable latch to release from the inner track of the handle body.

3. The catheter apparatus of claim 1, wherein the inner track of the handle body comprises one or more slots, wherein the at least one retractable latch is biased to push outwardly into the one or more slots to resist proximal retraction, and wherein the tensioning of the at least one cable over the threshold force retracts the at least one retractable latch from the one or more slots thereby allowing proximal retraction of the outer sheath.

4. The catheter apparatus of claim 3, wherein the one or more slots comprises a plurality of slots.

5. The catheter apparatus of claim 1, further comprising a sliding block coupling the proximal end of the outer sheath to the at least one retractable latch, wherein the sliding block is configured to slide along the inner track of the handle body.

6. The catheter apparatus of claim 1, further comprising a pulley operatively coupled to the at least one cable, wherein the pulley is configured to be actuated to proximally retract the at least one cable, and wherein the pulley is housed at least partially within the handle body.

7. The catheter apparatus of claim 6, wherein the pulley comprises a rotatable spool.

8. The catheter apparatus of claim 7, further comprising a finger wheel coupled to handle body and the rotatable spool, wherein the finger wheel is configured to be spun to actuate the pulley.

9. The catheter apparatus of claim 1, wherein the at least one latch comprises a plurality of latches.

10. The catheter apparatus of claim 9, wherein the at least one cable comprises a plurality of cables, each cable of the plurality being coupled to a corresponding latch of the plurality of latches.

11. The catheter apparatus of claim 1, further comprising a distal nose coupled to the distal portion of the inner shaft, the distal nose having a proximal end disposed distal to the implant holding region.

12. The catheter apparatus of claim 1, further comprising a stop block coupled to the distal portion of the inner shaft and disposed proximal to the implant holding region.

13. The catheter apparatus of claim 12, wherein the stop block is fixedly coupled to the distal portion of the inner shaft.

14. The catheter apparatus of claim 1, wherein the inner shaft comprises a hypotube having an inner lumen.

15. The catheter apparatus of claim 14, wherein the inner lumen of the hypotube comprises a guidewire lumen.

16. The catheter apparatus of claim 1, further comprising an anti-compression coil disposed between the inner shaft and the outer sheath to provide support for the inner shaft.

17. The catheter apparatus of claim 16, wherein the anti-compression coil comprises a proximal end and a distal end.

18. The catheter apparatus of claim 17, wherein the proximal end of the anti-compression coil is disposed distal to the at least one latch.

19. The catheter apparatus of claim 17, wherein the distal end of the anti-compression coil is disposed proximal of the implant holding region of the inner shaft.

20. The catheter apparatus of claim 1, wherein the outer sheath has a larger diameter distal region configured to enclose the implant holding region and a smaller diameter proximal region, and wherein proximal retraction of the larger diameter distal region exposes the implant holding region to allow the implant to be deployed.

21. The catheter apparatus of claim 20, further comprising a protective sleeve disposed over the smaller diameter proximal region.

22. The catheter apparatus of claim 21, wherein the protective sleeve has a distal end, and wherein a gap is defined between the larger diameter distal region of the outer sheath and the distal end of the protective sleeve to allow the larger diameter distal region to be proximally retracted.

23. The catheter apparatus of claim 1, wherein the implant comprises a stent-graft.

24. The catheter apparatus of claim 1, wherein the implant is self-expanding.

25. A method of delivering an implant, the method comprising:

advancing a catheter apparatus through a blood vessel to a target site; and

retracting an outer sheath of the catheter apparatus to expose the implant and allow the implant to be deployed, the implant having been disposed on an implant holding region of an inner shaft of the catheter apparatus,

wherein a proximal end of the outer sheath is coupled to at least one latch configured to resist retraction of the outer sheath,

wherein retracting the outer sheath of the catheter apparatus comprises tensioning at least one cable of the catheter apparatus over a threshold force, thereby releasing at least one latch to allow the at least one latch and the outer sheath to be proximally retracted, and

wherein the at least one retractable latch is biased to push outwardly against an inner track of a handle body of the catheter apparatus to provide friction to resist proximal retraction, and wherein the at least one latch is released by changing a configuration of the at least one retractable latch to release from the inner track of the handle body.

26. The method of claim 25, wherein the blood vessel comprises one or more of an aorta, a carotid artery, an external carotid artery, an internal carotid artery, a subclavian artery, an axillary artery, a brachial artery, a radial artery, an ulnar artery, a thoracic aorta, an abdominal aorta, a hypogastric artery, an external iliac artery, an internal iliac artery, a superior mesenteric artery, a renal artery, a femoral artery, a popliteal fossa, a popliteal artery, an anterior tibial artery, a dorsalis pedis artery, a posterior tibial artery, an arch of foot artery, a pulmonary vein, a vena cava, a superior vena cava, an inferior vena cava, a superior mesenteric vein, a jugular vein, an internal jugular vein, a subclavian vein, an axillary vein, a pulmonary artery, a cephalic vein, a basillic vein, a renal vein, a femoral vein, or a great saphenous vein.

27. The method of claim 25, wherein the catheter apparatus is advanced over a guidewire placed in the blood vessel.

28. The method of claim 25, wherein the implant comprises a stent-graft.

29. The method of claim 28, wherein the stent-graft comprises a femoral-popliteal stent-graft.

30. The method of claim 25, wherein the implant is self-expanding.

31. The method of claim 25, wherein tensioning the at least one cable comprises actuating a pulley within a handle body of the catheter apparatus.

32. The method of claim 31, wherein the pulley comprises a rotatable spool, and wherein actuating the pulley comprises spinning the rotatable spool with a finger wheel on the handle body.

33. The method of claim 25, wherein retracting the outer sheath of the catheter apparatus comprises narrowing a gap between a larger diameter distal region of the outer sheath and a distal end of a protective sleeve disposed at least partially over a smaller diameter proximal region of the outer sheath.

34. The method of claim 33, wherein the larger diameter distal region is configured to enclose the implant holding region of the inner shaft.

35. A method of delivering an implant, the method comprising:

advancing a catheter apparatus through a blood vessel to a target site; and

retracting an outer sheath of the catheter apparatus to expose the implant and allow the implant to be deployed, the implant having been disposed on an implant holding region of an inner shaft of the catheter apparatus,

wherein a proximal end of the outer sheath is coupled to at least one latch configured to resist retraction of the outer sheath,

wherein retracting the outer sheath of the catheter apparatus comprises tensioning at least one cable of the catheter apparatus over a threshold force, thereby releasing at least one latch to allow the at least one latch and the outer sheath to be proximally retracted, and

wherein the at least one retractable latch is biased to push outwardly into one or more slots in an inner track of a handle body of the catheter apparatus to resist proximal retraction, and wherein the tensioning of the at least one cable over the threshold force retracts the at least one retractable latch from the one or more slots thereby allowing proximal retraction of the outer sheath.

36. The method of claim 35, wherein the blood vessel comprises one or more of an aorta, a carotid artery, an external carotid artery, an internal carotid artery, a subclavian artery, an axillary artery, a brachial artery, a radial artery, an ulnar artery, a thoracic aorta, an abdominal aorta, a hypogastric artery, an external iliac artery, an internal iliac artery, a superior mesenteric artery, a renal artery, a femoral artery, a popliteal fossa, a popliteal artery, an anterior tibial artery, a dorsalis pedis artery, a posterior tibial artery, an arch of foot artery, a pulmonary vein, a vena cava, a superior vena cava, an inferior vena cava, a superior mesenteric vein, a jugular vein, an internal jugular vein, a subclavian vein, an axillary vein, a pulmonary artery, a cephalic vein, a basillic vein, a renal vein, a femoral vein, or a great saphenous vein.

37. The method of claim 35, wherein the catheter apparatus is advanced over a guidewire placed in the blood vessel.

38. The method of claim 35, wherein the implant comprises a stent-graft.

39. The method of claim 38, wherein the stent-graft comprises a femoral-popliteal stent-graft.

40. The method of claim 35, wherein the implant is self-expanding.

41. The method of claim 35, wherein tensioning the at least one cable comprises actuating a pulley within a handle body of the catheter apparatus.

42. The method of claim 41, wherein the pulley comprises a rotatable spool, and wherein actuating the pulley comprises spinning the rotatable spool with a finger wheel on the handle body.

43. The method of claim 35, wherein the at least one retractable latch is biased to push outwardly against an inner track of a handle body of the catheter apparatus to provide friction to resist proximal retraction, and wherein the at least one latch is released by changing a configuration of the at least one retractable latch to release from the inner track of the handle body.

44. The method of claim 35, wherein retracting the outer sheath of the catheter apparatus comprises narrowing a gap between a larger diameter distal region of the outer sheath and a distal end of a protective sleeve disposed at least partially over a smaller diameter proximal region of the outer sheath.

45. The method of claim 44, wherein the larger diameter distal region is configured to enclose the implant holding region of the inner shaft.