System and method of facilitating connection between cannulae and a blood pump

• US 10,449,274 B2
• Filed: 06/24/2014
• Issued: 10/22/2019
• Est. Priority Date: 06/26/2013
• Status: Active Grant

• Current Assignee: Circulite Inc. (Medtronic Plc)
• Original Assignee: Circulite Inc. (Medtronic Plc)
• Inventors: Fritz, Bryan P., Farnan, Robert C., Dusbabek, Andrew J., Marseille, Oliver, Camkiran, Murat, Thompson, Grant, Olson, Scott A.
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US14/313,270
• Publication Number:
  US 20150005570A1
• Time in Patent Office: 1,946 Days
• Field of Search: 600 16
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 2017/320056 Tunnelers
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 60/109 incorporated within extracorporeal blood circuits or systems
• CPC Class Codes: A61M 60/122 Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/226 the blood flow through the rotating member having mainly radial components
• CPC Class Codes: A61M 60/237 the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
• CPC Class Codes: A61M 60/857 Implantable blood tubes
• CPC Class Codes: A61M 60/865 Devices for guiding or inserting pumps or pumping devices into the patient's body

Abstract

A system for facilitating fluid connection between cannulae and a blood pump. The system includes a cannula having proximal and distal ends. The distal end of the cannula adapted to be in fluid communication with the circulatory system. The proximal end of the cannula configured to couple to an inlet of the blood pump. The system further includes a tunneling device configured to be inserted into a body of a patient to direct the proximal end of the cannula adjacent to the inlet for connection thereto. The cannula further includes a first connecting structure. The tunneling device further includes a second connecting structure. The first and second connecting structures are selectively engageable to allow connection and disconnection between the cannula and tunneling device.

Claims

1. A system for facilitating fluid connection between a blood pump and a circulatory system of a patient, comprising:

a cannula having proximal and distal ends, the distal end of the cannula adapted to be in fluid communication with the circulatory system, the proximal end of the cannula configured to couple to an inlet of the blood pump; and

a tunneling device configured to be inserted into a body of a patient to direct the proximal end of the cannula adjacent to the inlet for connection thereto;

wherein the cannula further comprises a first connecting structure; and

the tunneling device further comprises a second connecting structure, the first and second connecting structures being selectively engageable to allow in situ connection and disconnection between the cannula and tunneling device.

2. The system of claim 1, further comprising:

a plug configured to be inserted in the proximal end of the cannula, the plug including at least a portion of the first connecting structure.

3. The system of claim 2, wherein:

the second connecting structure further comprises a groove on the tunneling device; and

the first connecting structure further comprises;

a cavity in the plug for receiving a distal portion of the tunneling device, and

a rib on the plug, the rib engageable with the groove for securing the tunneling device relative to the plug.

4. The system of claim 3, wherein the tunneling device further includes a removable tip, and wherein the groove of the second connecting structure is positioned on the removable tip.

5. The system of claim 2, wherein the plug further comprises proximal and distal ends and a body therebetween, at least a portion of the body being tapered for dilating tissue.

6. The system of claim 2, wherein:

the second connecting structure is defined at least in part by threads;

the tunneling device further includes a detachable tip having threads for mating with the threads of the second connecting structure; and

the first connecting structure further includes;

an anchor positioned substantially within the plug;

a peg affixed to the anchor such that at least a portion of the peg protrudes from an end of the plug; and

a sleeve defined at least in part by threads for mating with the threads of the second connecting structure, the sleeve being positioned over the peg and attached thereto such that the sleeve may be rotated independent of the plug.

7. The system of claim 2, wherein:

the second connecting structure is defined at least in part by a clip comprising a sleeve having a plurality of expandable flanges;

the tunneling device further includes a detachable tip having a pin for frictionally engaging the clip of the second connecting structure; and

the first connecting structure further includes an anchor positioned substantially within the plug and a pin affixed to the anchor, such that the pin may frictionally engage the clip of the second connecting structure.

8. The system of claim 1, wherein at least one of the first or second connecting structures is defined at least in part by an aperture for accepting a loop of material for connection to the other of the first and second connecting structures.

9. The system of claim 8, wherein the loop further comprises one of the following:

a suture, wire, or medical tape.

10. The system of claim 1, wherein the first and second connecting structures are configured to frictionally engage one another.

11. The system of claim 10, wherein the first and second connecting structures are configured to allow a snap fit therebetween.

12. The system of claim 10, wherein the second connecting structure is defined at least in part by a clip comprising a sleeve having a plurality of expandable flanges and the first connecting structure is defined at least in part by a pin for frictionally engaging the clip of the second connecting structure, and wherein the tunneling device further includes a detachable tip having a pin for frictionally engaging the clip of the second connecting structure.

13. The system of claim 12, wherein at least one of the pin of the first connecting structure and the pin of the detachable tip has a relief channel, and wherein the clip further includes at least one tooth positioned on at least one of the plurality of flanges such that the at least one tooth is engageable with the relief channel for securing the pin relative to the clip.

14. The system of claim 12, wherein at least one of the pin of the first connecting structure and the pin of the detachable tip is tapered to provide smooth expansion of the flanges.

15. The system of claim 12, wherein the second connecting structure further comprises a retention sleeve for securing the plurality of flanges over at least one of the pin of the first connecting structure and the pin of the detachable tip.

16. The system of claim 15, wherein at least one of the clip and the retention sleeve comprises a taper.

17. The system of claim 1, wherein at least one of the first or second connecting structures further comprises a hook.

18. The system of claim 1, wherein the tunneling device further comprises:

a first elongate dilator; and

a second elongate dilator proximal of the first elongate dilator, wherein at least a portion of the second elongate dilator has a larger diameter than that of the first elongate dilator in order to dilate tissue a greater amount than the first elongate dilator.

19. The system of claim 18, wherein at least one of the first or second elongate dilators includes a portion having a constant diameter.

20. The system of claim 18, wherein the first and second elongate dilators are separate components, the second elongate dilator including a lumen for receiving at least part of the first elongate dilator.

21. The system of claim 19, further comprising a taper between the constant diameter portions of the first and second elongate dilators.

22. The system of claim 20, further comprising a locking mechanism on at least one of the first or second dilators configured to prevent relative movement therebetween.

23. The system of claim 1, wherein the first and second connecting structures are configured to magnetically couple.

24. The system of claim 1, wherein the second connecting structure is defined at least in part by threads and the first connecting structure is defined at least in part by threads for mating with the threads of the second connecting structure, and wherein the tunneling device further includes a detachable tip having threads for mating with the threads of the second connecting structure.

25. The system of claim 24, wherein the tunneling device further includes an elongate member coupled with the second connecting structure for providing selective rotation of the threads of the second connecting structure.

26. The system of claim 24, wherein the first connecting structure further includes an independently rotatable sleeve defined at least in part by the threads of the first connecting structure for mating with the threads of the second connecting structure.

27. A system for facilitating fluid connection between a blood pump and a circulatory system of a patient, comprising:

a cannula having proximal and distal ends, the distal end of the cannula adapted to be in fluid communication with the circulatory system, the proximal end of the cannula configured to couple to an inlet of the blood pump;

a plug configured to be inserted into the proximal end of the cannula; and

a tunneling device configured to be inserted into a body of a patient;

wherein the plug further comprises a first connecting structure; and

wherein the tunneling device further comprises a second connecting structure, wherein the first and second connecting structures are selectively engageable to allow in situ connection and disconnection between the cannula and tunneling device.

28. A method of facilitating fluid connection between a blood pump and a circulatory system of a patient, comprising:

directing a distal end of a cannula into fluid communication with the circulatory system;

inserting the blood pump into a body of the patient;

inserting a tunneling device into the body of the patient;

selectively engaging a first connecting structure of the cannula in situ with a second connecting structure of the tunneling device;

directing a proximal end of the cannula adjacent to an inlet of the blood pump; and

connecting the proximal end of the cannula to the inlet.

29. The method of claim 28, wherein directing the proximal end of the cannula step further comprises:

retracting at least a portion of the tunneling device such that a distal end thereof moves towards the pump.

30. The method of claim 29, wherein the retracting step further comprises dilating an intercostal space with a cannula plug inserted into the proximal end of the cannula.

31. The method of claim 28, wherein the tunneling device further comprises a first elongate dilator, and a second elongate dilator proximal of the first elongate dilator, wherein at least a portion of the second elongate dilator has a larger diameter than that of the first elongate dilator, and directing the tunneling device step further comprises:

dilating an intercostal space by a first amount with the first elongate dilator; and

dilating the intercostal space by a second amount with the second elongate dilator.

32. The method of claim 28, wherein before selectively engaging the connecting structures the method further includes removing a detachable tip of the tunneling device.

33. The method of claim 32, wherein the second connecting structure includes threads and wherein the first connecting structure and the detachable tip include threads for mating with the threads of the second connecting structure, and the method further includes:

disengaging the threads of the detachable tip from the threads of the second connecting structure; and

engaging the threads of the first connecting structure with the threads of the second connecting structure.

34. The method of claim 33, wherein the first connecting structure further includes an independently rotatable sleeve defined at least in part by the threads of the first connecting structure for mating with the threads of the second connecting structure, and engaging the threads of the first connecting structure with the threads of the second connecting structure includes rotating the sleeve independent of the cannula plug.

35. The method of claim 32, wherein the second connecting structure includes a clip comprising a sleeve having a plurality of expandable flanges and wherein the first connecting structure and the detachable tip each include a pin for frictionally engaging the clip, and the method further includes:

disengaging the pin of the detachable tip from the clip of the second connecting structure; and

engaging the pin of the first connecting structure with the clip of the second connecting structure.

36. The method of claim 35, wherein engaging the pin of the first connecting structure with the clip of the second connecting structure includes allowing the plurality of flanges to expand around the pin such that the plurality of flanges may frictionally engage the pin.

37. The method of claim 35, wherein the pin of the first connecting structure has a relief channel, and wherein the clip further includes at least one tooth positioned on at least one of the plurality of flanges such that the at least one tooth is engageable with the relief channel for securing the pin relative to the clip, and engaging the pin of the first connecting structure with the clip includes allowing the at least one tooth to engage with the relief channel.

38. The method of claim 35, wherein selectively engaging the connecting structures further comprises positioning a retention sleeve over the clip for securing the plurality of flanges over the pin of the first connecting structure.

39. The method of claim 28, wherein:

the second connecting structure includes a groove on the tunneling device;

the first connecting structure includes a cavity for receiving a distal portion of the tunneling device and a rib engageable with the groove for securing the tunneling device relative to the cannula; and

selectively engaging the connecting structures includes inserting the distal portion of the tunneling device into the cavity of the first connecting structure and allowing the rib of the first connecting structure to engage with the groove of the second connecting structure.

40. The method of claim 28, further comprising disengaging the connecting structures.