Staged implantation of ventricular assist devices

• US 20040147802A1
• Filed: 02/10/2004
• Published: 07/29/2004
• Est. Priority Date: 05/21/2001
• Status: Abandoned Application

• Current Assignee: Heartware,Inc. (Medtronic Plc), HeartWare Pty Ltd. (Medtronic Plc)
• Original Assignee: Heartware,Inc. (Medtronic Plc), HeartWare Pty Ltd. (Medtronic Plc)
• Inventors: Woodard, John Campbell, Tansley, Geoffrey Douglas
• Application Number:
  US10/478,410
• Publication Number:
  US 20040147802A1
• Time in Patent Office: Days
• US Class Current: 600/16
• CPC Class Codes: A61M 2039/0291 method or device for implanting it in the body
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• 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 60/216 including a rotating member acting on the blood, e.g. impeller
• CPC Class Codes: A61M 60/859 Connections therefor

Abstract

An implantation regime for a ventricular assist device (VAD) comprising implanting a first VAD (13) intended for short term use for a predetermined period of time and then determining whether the heart can operate without further assistance after this period of time. A second VAD (30) intended for long term use may then be implanted if necessary. Also disclosed are percutaneous leads (40) that have surface treatments (45, 47) to enable tissue ingrowth in certain areas and prevent tissue ingrowth in other areas, and an embolisation device (21, 22) carrying a coagulating material (27) for sealing an implanted cannula (15, 16) between the use of the first and second VADs.

Claims

1. A method of mechanically assisting a heart to pump blood;

said method comprising releasably, sealingly connecting a first ventricular assist device via a first cannula and a second cannula so as to at least assist said heart to pump said blood during a first predetermined period of time, ascertaining if mechanical assistance continues to be required and, if so, substituting a second ventricular assist device at the end of said first predetermined period of time and wherein said first and said second ventricular assist devices are implantable into a patient'"'"'s body and are both pumping devices and wherein said first ventricular assist device is adapted for short term use and wherein said second ventricular assist device is adapted for long term use.

2. The method of claim 1 wherein said cannulae are capable of being reused for connection of said first ventricular assist device or said second ventricular assist device.

3. The method of claim 2 wherein said first ventricular assist device incorporates short term life features which renders said first ventricular assist device suited to operation over a short life span.

4. The method of claim 3 wherein said short term life features include use of plastic material in one or more of the pump casing and pump rotor of said first ventricular assist device.

5. The method according to any one of the preceding claims wherein said cannulae are capable of being either permanently or temporarily scaled so as to allow permanent implantation of the cannulae without need to be connected to either said first ventricular assist device or said second ventricular assist device.

6. The method of claim 5 wherein said first cannula includes an end for connection to the aorta and a distal end connecting to either an inlet of a first ventricular assist device or an inlet of a second ventricular assist device, in use;

and said second cannula includes an end for connection to a ventricle and a distal end connecting to either an outlet of said first ventricular assist device or an outlet of said second ventricular assist device, in use.

7. The method of claim 6 wherein said second ventricular assist device is adapted for substitution of said first ventricular assist device following a first predetermined period of operation of said first ventricular assist device.

8. The method of claim 7 wherein the first cannula or the second cannula are adapted to receive the insertion of an embolisation device.

9. The method of claim 8 wherein said first ventricular assist device is made by an injection moulding process.

10. The method of claim 8 wherein said first ventricular assist device is made by a vacuum casting process.

11. The method of claim 8 wherein said first ventricular assist device includes a pump rotor made from a plastic material.

12. The method of claim 8 wherein said second ventricular assist device includes a pump casing made from a metallic material.

13. The method of claim 8 wherein said second ventricular assist device includes a pump casing made from a ceramic material.

14. The method of claim 8 wherein said second ventricular assist device includes a rotor made from ceramic material.

15. The method of claim 8 wherein said short term use is a period of time between 3 to 6 months.

16. The method of claim 8 wherein said long term use is a period of time between 1 to 10 years.

17. The method of claim 5 wherein said method includes a test procedure to determine whether heart can operate without the further assistance of said first ventricular assist device.

18. The method of claim 17 wherein said test procedure includes a monitoring operation of said heart over said predetermined period of time.

19. The method of either claims 1 or 5 wherein said method includes the use of an insulated percutaneous lead for supplying power to either a first or second ventricular assist device.

20. The method of claim 19 wherein a portion of an outer surface of said lead prevents incorporation of surrounding tissue.

22. The method of claim 19 wherein said surface comprises one surface texture.

23. The method of claim 19 wherein said lead includes at least two surface textures on predetermined portions of the surface of said lead, wherein a first surface texture allows incorporation of said lead into tissue and wherein a surface texture prevents incorporation of said lead into tissue.

24. The method of claim 23 wherein an amount of tissue incorporation of said lead can be varied to suit needs by arrangement of the surface textures.

25. The method of claim 24 wherein each of said surface textures comprises at least one application of a surface treatment to said lead.

26. The method of claim 25 wherein said surface texture is modified as to the degree to which said incorporation of portions of said lead into tissue surrounding said lead is promoted therein.

27. The method of claim 25 wherein said surface treatment includes an application of velour to the surface of said lead.

28. The method of claim 25 wherein said first surface texture has a labyrinth arrangement.

29. The method of claim 25 wherein said incorporation of portions of said lead into tissue surrounding is promoted controlled by selection of depth and shape of said surface textures.

30. The method of claim 29 wherein the portion allowing incorporation may extend to a length sufficient to anchor said lead to a site where said lead exits the body or proximal to said site.

31. The method of claim 30 wherein the second surface texture prevents incorporation so as to facilitate easy removal of the lead.

32. The method of claim 5 wherein the said method includes an embolisation device for insertably sealing a cannula, wherein said embolisation device comprises a scaling cap at a first end, a carrier surface at a second end and an elongate stem adapted to be inserted within the cannula.

33. The method of claim 32 wherein the carrier surface is adapted to carry a coagulating material.

34. The method of claim 33 wherein said embolisation device seals a cannula at a scaling point close to the heart.

35. The method of claim 34 wherein said sealing cap is adapted to be sealingly connected to a corresponding connector on the cannula.

36. The method of claim 35 wherein the elongated stem is of a length so that when the device is entirely inserted within said cannula, the carrier surface is positioned to deliver coagulating material to the sealing point.

37. The method of claim 36 wherein said embolisation device is connected removably and releasably to the cannula, in use.

21. The method of claim 21 wherein a portion of an outer surface of said lead allows incorporation of surrounding tissue.

38. An embolisation device for insertably sealing a cannula, wherein said embolisation device comprises a sealing cap at a first end, a carrier surface at a second end;

wherein the carrier surface is adapted to carry a coagulating material and induces an embolism at a position proximal to said second end and an elongate stem adapted to be inserted within the cannula.

39. The embolisation device of claim 38 wherein said embolisation device seals a cannula at a sealing point proximal to a heart of a patient, in use.

40. The emolisation device of claim 39 wherein said scaling cap is adapted to be sealingly connected to a corresponding connector of the cannula.

41. The emolisation device of claim 40 wherein the elongated stem is of a length so that when the device is entirely inserted within said cannula, the carrier surface is positioned to deliver coagulating material to a sealing point at some point proximal to a heart of a patient, in use.

42. The embolisation device of claim 40 wherein said scaling point is sufficiently close to the heart so that there is no requirement to remove the cannula from the body.

43. The embolisation device of claim 40 wherein said embolisation device is connected removably and releasably to the cannula, in use.