Medical implant device

Abstract

An improved implant device is deployed a vessel, or passageway, in a body with an attachment mechanism that permits stable and secure positioning of an implant device while also permitting easy removal without damaging the vessel. In particular, clip-like structures are used to engage the wall of the passageway. A tether that works in cooperation with the attachment mechanism may be used to facilitate removal of the implant device after an indicated period. The tether is removable from the implant device to convert the implant device into another configuration, which can remain permanently or be removed at a later time. Moreover, a centering mechanism may be employed to ensure that the implant device is properly oriented within the passageway when deployed.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an implant device that employs tissue clips to removably attach the implant device to the wall of a blood vessel according to an aspect of the present invention.

FIG. 2 illustrates a contact portion and a tissue clip that can be employed by the implant device of FIG. 1.

FIG. 3 illustrates an embodiment of a control mechanism that can be employed to affix the position of the implant device of FIG. 1 during deployment.

FIG. 4 illustrates another embodiment of a tissue clip of the present invention.

FIG. 5 illustrates yet another embodiment of a tissue clip of the present invention.

FIG. 6 illustrates a further embodiment of a tissue clip of the present invention.

FIG. 7 illustrates another embodiment of an implant device that employs tissue clips according to an aspect of the present invention.

FIG. 8 illustrates an embodiment of an implant device that employs tissue clips and a centering mechanism according to aspects of the present invention.

FIG. 9 illustrates a further embodiment of an implant device that employs tissue clips and a centering mechanism according to aspects of the present invention.

FIG. 10 illustrates an embodiment of an implant device that employs a tether in addition to tissue clips according to aspects of the present invention.

FIG. 11 illustrates an embodiment of an extension wire which is attachable to the tether of the implant device of FIG. 10.

FIG. 12 illustrates an embodiment of an release mechanism that can removably attach the tether to the implant device of FIG. 10.

Claims

1. An implant device, comprising: a clip for removably attaching the implant device to a wall of a body passageway, the clip comprising: a contact portion for contacting the wall of the passageway; anda clip leg with a sharp tip for engaging the wall of the passageway, the clip leg being positioned on the contact portion and extending away from the contact portion at an angle, the contact portion and the clip leg defining a space for receiving at least apart of the wall of the body passageway,wherein the contact portion and the clip leg resist an increase in the space between the contact portion and the clip leg.

2. The implant device according to claim 1, wherein the clip leg is substantially straight and substantially rigid.

3. The implant device according to claim 1, further comprising a plurality of elongate legs extending away from a longitudinal axis of the implant device at an angle, each of the plurality of elongate legs having a contact portion, wherein a clip leg is positioned at the contact portion of each of the plurality of elongate legs and extends at an angle from the contact portion.

4. The implant device according to claim 3, further comprising an apex, wherein each of the plurality of elongate legs has a connecting end connected at the apex.

5. The implant device according to claim 4, wherein each of the plurality of legs has a curved end opposite the connecting end, the curved end curving inwardly toward the longitudinal axis.

6. The implant device according to claim 5, wherein the plurality of elongate legs is collapsible for guiding the implant device to a position in the passageway and expandable for removable attachment to the wall of the passageway.

7. The implant device according to claim 6, wherein each of the plurality of elongate legs is flexibly bendable toward the longitudinal axis to make the plurality of elongate legs collapsible.

8. The implant device according to claim 3, wherein the implant device is a blood clot filter with a clot-capturing basket formed by the plurality of elongate legs.

9. The implant device according to claim 8, wherein the clot-capturing basket is formed by adjacent capturing ends of the plurality of elongate legs, the capturing ends not being joined to one another.

10. The implant device according to claim 9, wherein the clot-capturing basket is formed by overlapping of the elongate legs.

11. The implant device according to claim 9, further comprising a centering mechanism to keep the clot-capturing basket centered in the passageway.

12. The implant device according to claim 11, wherein the plurality of elongate legs are connected together at connected ends opposite the capturing ends, and wherein the centering mechanism is attached proximate to the connected ends and comprises a plurality of centering legs extending at an angle from the longitudinal axis of the implant device.

13. The implant device according to claim 12, wherein each centering leg has a centering clip for receiving at least a part of the wall of the body passageway, each centering clip being defined by each centering leg and a centering clip leg positioned on the centering leg, the centering clip leg extending at an angle from the centering leg, wherein the centering leg and the centering clip leg resist movement of the centering clip leg away from the centering leg.

14. The implant device according to claim 1, further comprising an aperture with an aperture width adapted to receive a control mechanism.

15. A system for attaching the implant device according to claim 14 to a wall of a body passageway, wherein the control mechanism comprises: an elongate tube with a proximal end, and a distal end having a plurality of longitudinal slits;a control wire that passes through the elongate tube; anda nodule connected to the control wire at the distal end of the tube, the nodule being movable with operation of the control wire to engage the longitudinal slits of the tube,wherein the control mechanism engages the implant device when the longitudinal slits at the distal end of the tube are passed through the aperture and the nodule engages the longitudinal slits, causing the tube, to expand outwardly at the longitudinal slits to an expanded width greater than the aperture width, and the control mechanism is releasable from the implant device when the longitudinal slits of the tube are free from engagement by the nodule and the tube has a non-expanded width less than the aperture width, allowing the tube section to pass through the aperture.

16. The system according to claim 15, further comprising a stopping mechanism with a width greater than the aperture width, the stopping mechanism being positioned on the elongate tube and spaced from the distal end of the tube so that the aperture is held between the distal end and the stopping mechanism when the control mechanism engages the implant device.

17. A system for controlling the implant device according to claim 1, the system comprising: a tether with a distal end and a proximal end, the tether being removably attached to the implant device at the distal end.

18. The system according to claim 17, further comprising an extension wire attached to the proximal end of the tether to extend the tether and to guide the sheath over the implant device.

19. The system according to claim 18, wherein the extension wire has a protrusion at the end of the extension wire that engages a slot at the proximal end of the tether.

20. A method for attaching the implant device according to claim 3 to a wall of a body passageway, the method comprising moving the implant device along the passageway in a first direction, thereby causing movement of the clip legs on the plurality of elongate legs into engagement with the wall of the passageway so that at least a part of the wall is received in the space between the elongate legs and the clip legs.

21. The method according to claim 20, wherein the implant device is a blood-clot filter and moving the implant device along the passageway in a first direction comprises moving the implant device along a blood vessel in a blood flow direction.

22. A method for removing the implant device according to claim 20 from attachment from the wall of a body passageway, the method comprising moving the implant device along the passageway in a second direction opposite the first direction, thereby causing movement of the clip legs on the plurality of elongate legs from engagement with the wall and removal of the wall from the space between the elongate legs and the clip legs.

23. The method according to claim 21, wherein the implant device is a blood-clot filter and moving the implant device along the passageway in the first direction comprises moving the implant device along the blood vessel against the blood flow direction.

24. A method for positioning the implant device according to claim 6 at a location in the passageway, the method comprising: positioning the implant within a retractable sheath;guiding the retractable sheath containing the implant device, the sheath keeping the implant device collapsed during movement through the passageway; andretracting the sheath from the implant device to allow the implant device to expand into attachment with the wall of the passageway at the location.

25. A method for removably attaching the implant device to a wall of a body passageway, comprising: providing a clip on the implant device, the clip comprising: a contact portion for contacting the Wall of the passageway; anda clip leg with a sharp tip for engaging the wall of the passageway, the contact portion and the clip leg defining a space therebetween;positioning the implant device at a location in the passageway; andmoving the implant device in a first direction to cause the clip leg to engage the wall, and a part of the wall to be clamped in the space between the contact portion and the clip leg.

26. The method according to claim 25, wherein positioning the implant device in the passageway further comprises: positioning the implant device within a retractable sheath;guiding the retractable sheath containing the implant device to the location in the passageway, the sheath keeping the clip from engaging the wall of the passageway; andretracting the sheath from the implant device to position the clip leg against the wall of the passageway at the location.

27. The method according to claim 25, further comprising moving the implant device along the passageway in a second direction opposite the first direction to cause the clip leg to disengage the wall, and the part of the wall to be removed from the space between the contact portion and the clip leg.

28. A system for deploying an implant device to be attached to a wall of a body passageway, the system comprising: an implant device with an attachment mechanism to attach the implant device to a wall in the passageway, the implant device having an aperture with an aperture width;a tether with a distal end and a proximal end, the proximal end being operable to control the body; anda release mechanism adapted to releasably connect the tether to the attachment portion of the implant device.

29. The system of claim 28, wherein the release mechanism comprises: a tube section extending from the distal end of the tether and having a plurality of longitudinal slits at an extended end of the tube section; anda control wire, operable from the proximal end of the tether, extending from the distal end of the tether and passing through the tube section, the control wire having a nodule movable to engage the extended end of the tube section, causing the tube section to expand outwardly to an expanded width greater than the aperture width due to the plurality of slits,wherein the tether is connected to the implant device when the tube section is passed through the aperture and the nodule engages the extended end of the tube section, and the tether is released from the implant device when the extended end of the tube section is free from engagement with the nodule and the tube section has a non-expanded width less than the aperture width, thereby allowing the tube section to pass through the aperture.

30. The system according to claim 29, further comprising a stopping mechanism with a width greater than the aperture width, the stopping mechanism being positioned on the tube section and spaced from the extended end of the tube section so that the aperture is held between the distal end and the stopping mechanism when the tether is connected to the implant device.

31. The system according to claim 28, wherein the attachment mechanism comprises a clip on the implant device including a contact portion for contacting the wall of the passageway, and a clip leg with a sharp tip for engaging the wall of the passageway, the contact portion and the clip leg defining a space therebetween.

32. The system according to claim 28, wherein the attachment mechanism comprises a hook.

33. A method for connecting the tether to the implant device in the system according to claim 29, the method comprising: passing the tube section through the aperture; andmoving, with the control wire, the nodule into engagement with the extended end of the tube section to cause the tube section to expand outwardly to the expanded width.

34. A method for releasing the tether from the implant device in the system according to claim 29, the method comprising: moving, with the control wire, the nodule from engagement with the extended end of the tube section to cause the tube section to shrink to the non-expanded width; andwithdrawing the tube section from the aperture.

35. A method for deploying an implant device in a body passageway, the implant device being collapsible for positioning in the passageway and expandable for removable attachment to a wall of the passageway, the method comprising: attaching a tether to the implant device, the tether having a distal end and a proximal end and being attached to the implant device at the distal end;guiding the implant device in a retractable sheath to a location in the passageway, the sheath keeping the implant device collapsed during movement through the passageway; andretracting the sheath from the implant device along the tether, thereby allowing the implant device to expand into attachment with the wall of the passageway at the location.

36. The method according to claim 35, further comprising: detaching the tether from the implant device by operating the proximal end of the tether and activating a release mechanism to release the implant device from the tether; andwithdrawing the tether from the passageway.

37. The method according to claim 36, further comprising removing the implant device, after detaching the tether, with a snare or capturing cone.

38. The method according to claim 37, further comprising removing the implant device from the passageway, removing the implant device comprising: guiding the sheath over the tether to the location of the implant device in the passageway and over the implant device to collapse the implant device; andwithdrawing the sheath, implant device, and tether from the passageway.

39. The method according to claim 38, further comprising removing the implant device from the passageway by extending the tether with an extension wire to the tether in order to guide the sheath over the tether and the implant device, whereby the implant device is collapsed and removable from the passageway.

40. The method according to claim 39, wherein extending the tether with an extension wire comprises guiding a protrusion at an end of the extension wire into contact with the tether and into engagement with a slot at the proximal end of the tether.

41. The method of claim 36, further comprising storing the proximal end of the tether subcutaneously.

42. The method according to claim 35, wherein guiding the implant device further comprises centering a part of the implant device near the center of the passageway with a centering mechanism attached to the tether proximate to the implant device.

43. The method according to claim 42, further comprising: guiding the retractable sheath containing the centering mechanism with the implant device, the sheath keeping the centering mechanism collapsed during movement through the passageway, andretracting the sheath from the centering mechanism to allow the centering mechanism to expand into centering contact with the wall of the passageway at the location,wherein the centering mechanism is collapsible for deployment and expandable to engage the wall of the passageway.

44. A system for deploying an implant device in a body passageway, the implant device being collapsible for positioning in the passageway and expandable for removable attachment to a wall of the passageway, the system comprising: a tether attachable to the implant device, the tether having a distal end and a proximal end, and being attached to the implant device at the distal end; anda flexible, retractable sheath with an elongate channel, the tether extending through the sheath, the implant device being collapsible within the channel and expandable when the sheath is retracted along the tether from the implant device.

45. The system according to claim 44, wherein the proximal end of the tether is operable to activate a release mechanism to detach the tether from the implant device.

46. The system according to claim 44, further comprising a snare or capturing cone for removing the implant device.

47. The system according to claim 44, wherein the sheath is guidable over the tether and over the implant device to collapse the implant device.

48. The system according to claim 44, further comprising an extension wire attachable to the tether, the sheath being guidable over the extension wire and tether to collapse the implant device.

49. The system according to claim 48, further comprising: a slot at the proximal end of the tether; anda protrusion at an end of the extension wire adapted to engage the slot of the tether in order to attach the extension wire to the tether.

50. The system according to claim 44, further comprising a centering mechanism attachable to the tether proximate to the implant device to center a part of the implant device.

51. The system according to claim 50, wherein the centering mechanism is collapsible within the channel of the retractable sheath and expandable when the sheath is retracted along the tether from the implant device.

52. The system according to claim 44, wherein the centering mechanism comprises a longitudinal axis and a plurality of centering legs, each of the plurality of centering legs extending along the longitudinal axis and away from the longitudinal axis.

53. A method for deploying an implant device in a body passageway, the implant device having an attachment mechanism to attach the implant device to a wall in the passageway, the method comprising: attaching a centering mechanism to the implant device proximate to a centered part of the implant device to be kept near the center of the passageway, the centering mechanism comprising at least one extension extending outwardly from the centered part of the implant device for spacing the wall from the centered part;guiding the implant device with the centering mechanism to a location in the passageway; andattaching the implant device to the wall with the attachment mechanism while the centering mechanism keeps the centered part of the implant device near the center of the passageway.

54. The method according to claim 53, wherein the centering mechanism comprises a plurality of legs, each of the plurality of legs having an end extending outwardly in a plurality of directions from the centered part of the implant device, into contact against the interior surface of the wall of the passageway.

55. The method according to claim 53, wherein the plurality of legs are evenly spaced in a circular arrangement.

56. The method according to claim 53, wherein the centering mechanism is a part of a tether attached to the implant device.

57. The method according to claim 53, wherein the centering mechanism is collapsible for deployment and expandable to engage the wall of the passageway.

58. The method according to claim 53, wherein the implant device is collapsible for positioning in the passageway and expandable for attachment to a wall of the passageway, and wherein guiding the implant device with the centering mechanism comprises moving the retractable sheath containing the implant device with the centering mechanism, the sheath keeping the implant device and the centering mechanism collapsed during movement through the passageway, and wherein attaching the implant device to the wall with the attachment mechanism comprises retracting the sheath from the implant device to permit the implant device and the centering mechanism to expand into contact with the wall of the passageway.