Deployment device, system and method for medical implantation

• US 20030125790A1
• Filed: 08/27/2002
• Published: 07/03/2003
• Est. Priority Date: 12/27/2001
• Status: Abandoned Application

• Current Assignee: Remon Medical Technologies Ltd. (Boston Scientific Corporation)
• Original Assignee: Remon Medical Technologies Ltd. (Boston Scientific Corporation)
• Inventors: Burstein, Yehiel, Rozenman, Yoseph, Yarden, Orit, Fastovsky, Vitaly
• Application Number:
  US10/228,268
• Publication Number:
  US 20030125790A1
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/413 Monitoring transplanted tissue or organ, e.g. for possible rejection reactions after a transplant
• CPC Class Codes: A61B 5/6862 Stents
• CPC Class Codes: A61B 5/6876 Blood vessel
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61B 5/6886 Monitoring or controlling distance between sensor and tissue
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61N 1/05 : for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/057 : Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 2001/0585 : Coronary sinus electrodes

Abstract

A deployment device for deploying a self-expansible medical implant at a target location in a body cavity, is provided. While generally, the expansion of self-expansible structures tends to be abrupt, and the impact of expansion may cause injury, a two-stage expansion process of the present invention minimizes the impact of exapnsion. Additionally, an ability to manuever the medical imlant into position, after the first stage of expansion, provides for accurate positioning.

Thus the present invention is of a deployment device for precise and well-controlled manner of deployment, so as to minimize damage to the cavity wall and to position the implant accurately at the target location.

The deployment device includes: an inner tube; an outer tube; and an implant received on the inner tube and enclosed by the outer tube. The implant has a self-expansible anchoring element which is in a contracted condition when enclosed by the outer tube, expands to a partially-expanded condition when the outer tube is retracted, and expands to a fully-expanded condition when the inner tube is removed.. The implant is deployed by introducing the deployment device to the target location in the body cavity; retracting the outer tube with respect to the implant such that the anchoring element self-expands from its contracted condition to its partially-expanded condition; and withdrawing the inner tube from the implant such that the anchoring element self-expands from its partially-expanded condition to its fully-expanded condition to firmly fix the implant at the target location within the body cavity.

Claims

1. A deployment device for deploying an implant, said implant being or having a self-expansible anchoring element, at a target location in a body cavity, comprising:

an outer tube;

an inner tube being translatably accepted in said outer tube and being designed for receiving the implant thereon,

such that said self-expansible anchoring element is in a contracted condition when enclosed by said outer tube, expansible to a partially-expanded condition when received on said inner tube and the outer tube is retracted, and further expansible to a fully-expanded condition when the inner tube is removed.

2. The device according to claim 1, wherein said inner tube is designed to translatably accept a guide wire therethrough.

3. The device according to claim 1, wherein said device further includes a retainer, to prevent the implant from sliding along the inner tube, together with the retracting outer tube.

4. The device according to claim 3, wherein said retainer is an intermediate tube located between said inner and outer tubes.

5. The device according to claim 1, wherein receiving the implant on the inner tube is effectable by fixing at least a portion of said anchoring element around said inner tube, so as to restrict the implant to the partially-expanded condition of the anchoring element when the implant is free of other restraining forces.

6. The device according to claim 5, wherein fixing is selected from the group consisting of wrapping, coiling, hooking, inserting into slots, and a combination thereof.

7. The device according to claim 1, further comprising a guide wire to be passed through said inner tube for guiding said implant, inner tube, and outer, tube, to the target location in the body cavity.

8. The device according to claim 1, further comprising a balloon which is inflatable to a size corresponding to the size of the body cavity at said target location to thereby facilitate locating the implant, inner tube, and outer tube, at said target location.

9. The device according to claim 1, wherein said lumen is a blood vessel, and said device further includes a balloon which is inflatable to propel the implant, inner tube, and outer tube, by blood flow to the target location within the blood vessel.

10. The device according to claim 9, wherein said balloon is fixed to the distal end of said outer tube.

11. The device of claim 1, wherein said implant comprises a power source.

12. The device of claim 1, wherein said implant comprises an extracorporeally energizeable power source.

13. The device of claim 1, wherein said implant is capable of telemetric communication with an extracorporeal device.

14. The device of claim 1, wherein said implant being or having a self-expansible anchoring element is a stent.

34. The method according to claim 31, wherein said deployment device is located at said target location by a balloon which is inflated to a size corresponding to the size of the body cavity at said target location.

40. The method according to claim 34, wherein said anchoring element is or includes an elastic spring wire.

41. The method according to claim 34, wherein said anchoring element is or includes an elastic spring leaf.

15. A deployment system for deploying an implant at a target location in a body cavity, comprising:

an outer tube;

an inner tube being translatably accepted in said outer tube; and

an implant received on said inner tube and enclosed by said outer tube;

said implant being or having a self-expansible anchoring element which is in a contracted condition when enclosed by said outer tube, expands to a partially-expanded condition when the outer tube is retracted, and expands to a fully-expanded condition when the inner tube is removed.

16. The system according to claim 15, wherein said inner tube is designed to translatably accept a guide wire therethrough.

17. The system according to claim 15, wherein said device further includes a retainer, to prevent the implant from sliding along the inner tube, together with the retracting outer tube.

18. The system according to claim 17, wherein said retainer is an intermediate tube located between said inner and outer tubes.

19. The system according to claim 15, wherein at least a portion of said anchoring element is fixed to said inner tube, so as to restrict the implant to the partially-expanded condition of the anchoring element when the implant is free of other restraining forces.

20. The system according to claim 19, wherein the manner by which said anchoring element is fixed to said inner tube is selected from the group consisting of wrapping, coiling, hooking, inserting into slots, and a combination thereof.

21. The system according to claim 19, wherein said anchoring element is or includes an elastic spring wire.

22. The system according to claim 19, wherein said anchoring element is or includes an elastic spring leaf.

23. The system according to claim 15, further comprising a guide wire to be passed through said inner tube for guiding said implant, inner tube, and outer tube, to the target location in the body cavity.

24. The system according to claim 15, further comprising a balloon which is inflatable to a size corresponding to the size of the body cavity at said target location to thereby facilitate locating the implant, inner tube, and outer tube, at said target location.

25. The system according to claim 15, wherein said lumen is a blood vessel, and said device further includes a balloon which is inflatable to propel the implant, inner tube, and outer tube, by blood flow to the target location within the blood vessel.

26. The system according to claim 25, wherein said balloon is fixed to the distal end of said outer tube.

27. The system of claim 15, wherein said implant comprises a power source.

28. The system of claim 15, wherein said implant comprises an extracorporeally energizeable power source.

29. The system of claim 15, wherein said implant is capable of telemetric communication with an extracorporeal device.

30. The system of claim 15, wherein said implant being or having a self-expansible anchoring element is a stent.

31. A method of deploying an implant at a target location in a body cavity, comprising:

introducing a deployment system according to claim 15 into the body cavity and maneuvering said deployment system to said target location in the body cavity;

retracting said outer tube with respect to said implant such that the anchoring element of the implant self-expands from its contracted condition to its partially-expanded condition; and

withdrawing said inner tube from the implant such that the anchoring element of the implant self-expands from its partially-expanded condition to its fully-expanded condition and becomes deployed at said target location within said body cavity.

32. The method according to claim 31, wherein, after retracting said outer tube to self-expand the anchoring element from its contracted condition to its partially-expanded condition, said inner tube is manipulated to adjust the position or orientation of the implant within the body cavity before withdrawing said inner tube to fully-expand the anchoring element.

33. The method according to claim 31, wherein said deployment device is guided to said target location in the body cavity by a guide wire passed through said inner tube.

35. The method according to claim 31, wherein said balloon is located at the distal end of said outer tube.

36. The method according to claim 31, wherein said lumen is a blood vessel, and said method further includes a balloon which is inflated to propel the implant, inner tube, and outer tube, by the blood flow to the target location within the blood vessel.

37. The method according to claim 31, wherein said implant is retained on the inner tube, upon retraction of the outer tube, by a retainer.

38. The method according to claim 31, wherein a portion of said anchoring element is fixed to said inner tube in the partially-expanded condition of the anchoring element when the implant is enclosed by said outer tube.

39. The method according to claim 38, wherein the manner by which said anchoring element is fixed to said inner tube is selected from the group consisting of wrapping, coiling, hooking, inserting into slots, and a combination thereof.

42. The method of claim 31, wherein said implant comprises a power source.

43. The method of claim 31, wherein said implant comprises an extracorporeally energizeable power source.

44. The method of claim 31, wherein said implant is capable of telemetric communication with an extracorporeal device.

45. The method of claim 31, wherein said implant being or having a self-expansible anchoring element is a stent.