ASSEMBLY AND METHOD OF IMPLANTING A HEART ASSIST SYSTEM

• US 20120296151A1
• Filed: 05/17/2012
• Published: 11/22/2012
• Est. Priority Date: 05/18/2011
• Status: Active Grant

• Current Assignee: Thoratec LLC
• Original Assignee: Thoratec LLC
• Inventors: Curtis, Donald, Hoarau, Carine, Baumberger, Alicia, Di Paola, John Mark, Harold, Nathan, Franco, Fabian
• Granted Patent: US 8,827,887 B2
• Time in Patent Office: Days
• US Class Current: 600/16
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1125 Forceps, specially adapted for performing or assisting anastomosis
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/3443 with means for adjusting the length of a cannula
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• 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 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• CPC Class Codes: A61M 60/232 Centrifugal pumps
• 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 60/508 : Electronic control means, e.g. for feedback regulation
• CPC Class Codes: A61M 60/857 : Implantable blood tubes
• CPC Class Codes: A61M 60/861 : Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
• CPC Class Codes: A61M 60/863 : Apex rings
• CPC Class Codes: A61M 60/865 : Devices for guiding or inserting pumps or pumping devices into the patient's body
• CPC Class Codes: A61M 60/88 : Percutaneous cables

Abstract

A needle guard is used when suturing the cuff of an attachment ring to the heart. The needle guard is disposed in the attachment ring to prevent other parts of the attachment ring from being punctured by a suturing needle. The needle guard can include one or more grooves to inhibit relative movement between the needle guard and the attachment ring during suturing. The needle guard is removed upon completion of suturing and to allow insertion into attachment ring of an inflow conduit of a heart assist device. An articulated clamp is used to compress the attachment ring into engagement with the inflow conduit. The attachment include an annular rib that grabs the inflow conduit.

Claims

1. A needle guard for use with a cardiac attachment ring of a heart assist system, the needle guard comprising:

a cylinder including a top end, a bottom end surface, and cylindrical side surface defining an outer diameter; and

a stop member at the top end of the cylinder, the stop member having a maximum width greater than the outer diameter of the cylindrical side surface.

2. The needle guard of claim 1, further comprising a handle at the top end of cylinder.

3. The needle guard of claim 2, wherein the handle comprises a stem and a pull member wider than the stem, the stem disposed between the pull member and the cylinder.

4. The needle guard of claim 1, wherein the cylindrical side surface includes a first groove that extends circumferentially around the cylinder.

5. The needle guard of claim 4, wherein the cylindrical side surface includes a second groove that extends circumferentially around the cylinder, the first groove located axially between the second groove and the bottom end surface.

6. The needle guard of claim 5, wherein the second groove is adjacent the stop member.

7. An assembly for attaching a heart assist device to the heart, the assembly comprising:

an attachment ring having a ring channel extending through the attachment ring, the attachment ring including a cylindrical ring wall and a cuff extending radially outward from the cylindrical ring wall, the cylindrical ring wall extending circumferentially around the ring channel; and

a needle guard including a cylinder shaped and sized to pass through the ring channel.

8. The assembly of claim 7, wherein the cylinder has a maximum outer diameter that is the same or about the same as an inner diameter of the cylindrical ring wall.

9. The assembly of claim 7, wherein an axial length of the cylinder is the same or about the same as a maximum axial length of the ring channel.

10. The assembly of claim 7, wherein an axial length of the cylinder is greater than a maximum axial length of the ring channel.

11. The assembly of claim 7, wherein the cylindrical ring wall includes a protrusion that extends radially inward into the ring channel, the protrusion located on a central segment of the cylindrical ring wall.

12. The assembly of claim 7, wherein the cylinder of the needle guard includes a groove that extends circumferentially around the cylinder.

13. The assembly of claim 12, wherein the attachment ring includes a ring seal configured to engage the groove.

14. The assembly of claim 12, wherein the cylinder of the needle guard includes another groove that extends circumferentially around the cylinder.

15. A method of attaching an attachment ring of a heart assist system to the heart, the method comprising:

inserting a needle guard into an attachment ring; and

inserting a suture through heart tissue and a cuff of the attachment ring while the needle guard is temporarily disposed within the attachment ring, the suture connecting the attachment ring to the heart tissue.

16. The method of claim 15, wherein the inserting of the needle guard includes abutting a stop member of the needle guard against a top end of the attachment ring.

17. The method of claim 15, wherein the inserting of the needle guard includes aligning a groove on a cylindrical side surface of the needle guard with a ring seal of the attachment ring.

18. The method of claim 15, wherein the inserting of the suture is performed while a bottom tip of the needle guard is located below an outer surface of the heart tissue.

19. The method of claim 15, further comprising removing the needle guard out of the attachment ring after the inserting of the suture.

20. The method of claim 15, wherein the inserting of the suture includes:

passing a needle into the heart tissue at a point located radially outward from the cuff, the needle connected to the suture;

followed by

passing the needle out from the heart tissue at a point located directly beneath the cuff;

followed by

passing the needle up through the cuff so that the suture is pulled through the heart tissue and the cuff.

21. A ring clamp for securing an inflow conduit to an attachment ring, the ring clamp comprising:

a first curved piece including a first end, a second end, and a first engagement member at the second end;

a second curved piece including a first end and a second end, the first end of the second curved piece pivotally connected to the first end of the first curved piece;

a third curved piece including a first end, a second end, and a second engagement member at the second end, the second engagement member configured to selectively engage and disengage the first engagement member; and

a lever including a first lever end, a second lever end, and a medial segment, the first lever end pivotally connected to the first end of the third curved piece, the medial segment pivotally connected to the second end of the second curved piece.

22. The ring clamp of claim 21, wherein the first engagement member is a hook and the second engagement member is a catch.

23. The ring clamp of claim 21, wherein the first curved piece, the second curved piece, or the third curved piece includes a compliance feature configured to circumferentially expand under tension and autonomously contract after expansion.

24. The ring clamp of claim 23, wherein the compliance feature includes a series of curved segments configured to bend when tension is applied to opposite ends of the compliance feature.

25. The ring clamp of claim 23, wherein the compliance feature includes an undulating wall having a wall thickness less than that of adjacent portions of the curved piece including the compliance feature.

26. The ring clamp of claim 23, wherein the compliance feature is formed of a material having an elasticity that differs from the material of adjacent portions of the curved piece including the compliance feature.

27. The ring clamp of claim 21, wherein the third curved piece includes a groove.

28. The ring clamp of claim 27, wherein the lever fits within the groove.

29. The ring clamp of claim 27, wherein the ring clamp has a closed orientation in which the lever is disposed in the groove, the second engagement member is engaged to the first engagement member, and the first curved piece, the second curved piece, and the third curved piece complete a circular ring having an inner diameter.

30. The ring clamp of claim 21, wherein the ring clamp has a closed orientation in which the second lever end is disposed adjacent the first engagement member, the second engagement member is engaged to the first engagement member, and the first curved piece, the second curved piece, and the third curved piece complete a circular ring having an inner diameter.

31. The ring clamp of claim 21, wherein the second curved piece includes two leg members attached to the medial segment of the lever, and the lever is sized to fit between the two leg members.

32. The ring clamp of claim 21, wherein the lever and the third curved piece include detent features configured to engaged each other.

33. The ring clamp of claim 32, wherein at least one of the detent features is disposed on a cantilevered member on the third curved piece.

34. A ring clamp for securing an inflow conduit to an attachment ring, the ring clamp comprising:

a lever; and

a plurality of curved pieces, the lever and the curved pieces pivotally connected to each other, at least one of the curve pieces including a compliance feature configured to expand under tension and autonomously contract after expansion,

wherein the lever is pivotally attached to two of the curved pieces, the plurality of curved pieces includes a first curved piece, a second curved piece, and a third curved piece, and wherein the first curved piece is configured to selectively engage and disengage the third curved piece.

35. The ring clamp of claim 34, wherein the lever is pivotally attached to the second curved piece and to the third curved piece.

36. The ring clamp of claim 34, wherein the third curved piece includes a groove configured to receive the lever.

37. The ring clamp of claim 34, wherein the compliance feature includes a series of curved segments configured to bend when tension is applied to opposite ends of the compliance feature.

38. The ring clamp of claim 34, wherein the compliance feature includes an undulating wall having a wall thickness less than that of adjacent portions of the curved piece including the compliance feature.

39. The ring clamp of claim 34, wherein the compliance feature is formed of a material having an elasticity that differs from the material of adjacent portions of the curved piece including the compliance feature.