Methods and devices for deployment into a lumen

Abstract

The invention described is directed to an intracorporeal occluding device having elements with non-traumatic ends and devices, systems and methods for occluding the lumens of anatomical passageways and/or for delivering drugs or other substances to the bodies of human or animal subjects.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevational view of a prior art occluding device.

FIG. 2 is an elevational view of an occluding device having a single spider segment.

FIG. 3 is an end view of the occluding device shown in FIG. 1.

FIG. 4 is an elevational view of an occluding device having a plurality of interconnected spider segments in expanded configurations.

FIG. 4A is an elevational view of the occluding device shown in FIG. 4 compressed into a contracted configuration, which is typically the configuration that is used when delivering the device to a location such as a fallopian tube.

FIGS. 5A-5D are elevational views of various occluding devices illustrating various non-traumatic ends.

FIG. 6 is an elevational view of the occluding device having a single spider segment.

FIG. 7 is an elevational view of the occluding device having a single spider segment.

FIGS. 8A-8D are elevational views of occluding devices having a plurality of interconnected spider segments in expanded configurations.

FIGS. 9A-9B are elevational views of occluding devices having a single spider segment.

FIGS. 10A-10B are elevational views of occluding devices having a single spider segment.

FIGS. 11, 11A and 11B are elevational views of an occluding device having a single spider segment with various non-traumatic ends.

FIGS. 11C-11D are an isometric and end view respectively of an occluding device having a single spider segment.

FIG. 11E is an elevational view of an occluding device having a single spider segment.

FIG. 11F is an elevational view of an occluding device having a single spider segment.

FIG. 11G is a close-up cross-sectional view of a non-traumatic end of FIG. 11F.

FIGS. 11H-11I are close up top-views of alternate non-traumatic ends of FIG. 11F.

FIGS. 12A-12B are isometric and elevational views of an occluding device having a single spider segment with a membrane.

FIG. 13A is an elevational view of an occluding device having a single brush element.

FIG. 13B is an elevational view of an occluding device having a plurality of brush elements.

FIG. 14A is an elevational view, partially in sectional view, of a rapid exchange-type delivery catheter illustrating the advancement of an occluding device embodying features of the invention.

FIGS. 14B and 14C are transverse cross-sectional views of the delivery catheter and guide wire shown in FIG. 14A taken along the lines 6-6 and 7-7 respectively.

FIG. 14D is an elevational view of an over-the-wire type delivery catheter.

FIG. 14E is a transverse cross-section of the over-the-wire delivery catheter shown in FIG. 14D, taken along the lines 9-9.

FIG. 14F is an elevational view, partially in section, of the distal section of the over-the-wire delivery catheter shown in FIG. 14D illustrating the advancement of an occluding device embodying features of the invention within the inner lumen of the delivery catheter by a pusher element after the guidewire has been withdrawn.

FIG. 14G is an elevational view, partially in section, of an over-the-wire delivery catheter with a combined guide wire-pusher element advancing an occluding member embodying features of the invention through the inner lumen of the catheter.

FIG. 14H is a transverse cross-sectional view of the delivery catheter shown in FIG. 14I taken along the lines 12-12.

FIG. 15A is an elevational view of an occlusion device embodying features of the invention disposed within a body lumen such as a female's fallopian tube.

FIG. 15B is a partial elevational view of the occluding device shown in FIG. 14A with fibrous material disposed about the expansive elements and a connecting member.

FIG. 15C is an elevational view of an occluding device having a plurality of interconnected and opposing spider segments in expanded configurations.

FIG. 16A is an elevational view of an occluding device contained with a delivery catheter.

FIG. 16B is an elevational view of the released occluding device shown in FIG. 16A.

FIG. 16C is an elevational view of an expanded occluding device with flower petals elements.

FIG. 16D is a side view of an expanded occluding device with flower petals elements and unexpanded hydrogel center.

FIG. 16E is a side view of an expanded occluding device with flower petals elements and expanded hydrogel center.

FIG. 17A is a side view of one embodiment of a lumen occluding and/or substance delivery device according to the present invention, disposed in a collapsed configuration (as it may exist when being delivered in a delivery device).

FIG. 17B is a side view of the device of FIG. 17A, disposed in an expanded configuration.

FIG. 17C is a side view of the device of FIGS. 17A and 17B, disposed in an expanded configuration and having an optional substance delivery and/or ingrowth supporting matrix thereon.

FIG. 18A is an exploded perspective view of one embodiment of system of the present invention comprising a lumen occluding/substance delivery device as shown in FIGS. 17A and 17B, in combination with a delivery cannula and a pusher device.

FIG. 18B is a perspective view of the system of FIG. 18A wherein the pusher has been used to expel the lumen occluding/substance delivery device out of the distal end of the delivery catheter.

FIG. 19A is a partial longitudinal sectional view of another embodiment of system of the present invention designed for over-the-wire delivery of the implantable device.

FIG. 19B is a showing of the system of FIG. 19A with the guidewire protruding from the distal end of the delivery catheter.

FIG. 20 is a sectional showing of the uterus and left fallopian tube of a human patient having the over-the-wire system of FIGS. 19A and 19B inserted into the left fallopian tube.

FIGS. 20A-20C show three steps in a procedure wherein the system shown in FIG. 20 is used to implant a lumen occluding/substance delivery device in the patient's left fallopian tube; the implant includes an exemplary embodiment of non-traumatic ends on the implant.

FIG. 21 is an enlarged perspective view of a lumen occluding/substance delivery device of the present invention having an optional substance delivery and/or ingrowth supporting matrix thereon.

FIG. 21A is an enlarged, cut away view of a portion of the substance delivery and/or ingrowth supporting matrix of the device of FIG. 21 illustrating one way in which the substance delivery and/or ingrowth supporting matrix may be constructed to deliver a substance following its implantation within the body of a patient.

FIG. 21B is an enlarged view of a portion of the substance delivery and/or ingrowth supporting matrix of the device of FIG. 21 illustrating another way in which the substance delivery and/or ingrowth supporting matrix may be constructed to deliver a substance following its implantation within the body of a patient.

FIG. 22 is an enlarged perspective view of a lumen occluding/substance delivery device (with non-traumatic ends) of the present invention having an optional substance delivery and/or ingrowth supporting matrix thereon and wherein portions of the device are constructed to carry out controlled delivery of a substance following its implantation within the body of a patient.

FIG. 22A is an enlarged view of a portion of the device of FIG. 22 illustrating one way in which the device may be constructed to deliver a substance following its implantation within the body of a patient.

FIG. 22B is an enlarged view of a portion of the device of FIG. 22 illustrating another way in which the device may be constructed to deliver a substance following its implantation within the body of a patient.

FIG. 22C is an enlarged view of a portion of the device of FIG. 22 illustrating yet another way in which the device may be constructed to deliver a substance following its implantation within the body of a patient.

FIG. 23 is a side view of a lumen occluding/substance delivery device (with non-traumatic ends) according to the present invention, disposed in a collapsed configuration and having a substance delivery reservoir thereon.

FIG. 23A is a side view of the device of FIG. 23 disposed in an expanded configuration.

FIG. 23B is an enlarged perspective view of the substance delivery reservoir of the device of FIGS. 23 and 23A.

FIG. 24 is a perspective view of another embodiment of a lumen occluding/substance delivery device according to the present invention having an optional visualization member thereon.

FIG. 24A is an enlarged view of a portion of the device of FIG. 24.

FIG. 25 is a sectional showing of the uterus and left fallopian tube of a human patient having a hysteroscope and a delivery system according to the present invention inserted into the left fallopian tube.

FIG. 25A is an enlarged view of the distal end of the hysteroscope and adjacent portion of segment 25A of FIG. 25, showing advancement of the delivery catheter out of a working channel of the hysteroscope.

FIG. 26A is a sectional view of a vessel showing the manner in which implantation of a lumen occluding/substance delivery device of the present invention may block the flow and/or to deliver an antineoplastic or antitumor substance to a tumor shown in FIG. 26.

FIG. 27 is a view of the lungs of a patient into which an occlusive delivery device of the invention has been inserted.

FIG. 27A is an expanded, partially cut-away view of the portion of FIG. 27 indicated by the dashed circle.

FIG. 27B is a cut-away view of a portion of a patient's lung showing the delivery catheter and the occlusive device in place.

Claims

1. An occluding member for a patient's reproductive lumen having at least one segment with a first contracted configuration and a second expanded configuration, comprising: a. a first expansive element having a first end secured to a central location in the occluding member and a non-traumatic end radially spaced from the first end when in an expanded configuration; andb. at least one additional expansive element having a first end secured to the central location in the occluding member and a non-traumatic end radially spaced from the central location in the expanded configuration.

2. The device of claim 1 wherein at least one of the expansive elements has a first section extending from the first end of the element which is oriented toward a first end of the occluding device and a second section extending to the second end of the expansive element which is oriented toward a second end of the occluding device.

3. The device of claim 2 wherein at least one of the first and second expansive sections of the expansive elements are straight.

4. The device of claim 2 wherein at least one of the first and second expansive sections of the expansive elements are curved.

5. The device of claim 2 wherein a least the first section of the first expansive member is oriented toward a first end of the occluding member and the first section of the second expansive element is oriented toward a second end of the occluding member.

6. The device of claim 2 wherein the first and additional expansive elements are configured into a spider segment.

7. The device of claim 6 having a plurality of axially aligned spider segments.

8. The device of claim 1 wherein the expansive elements are self expansive from a constricted configuration to an expanded configuration.

9. The device of claim 8 wherein the expansive elements are formed at least in part of superelastic NiTi alloy which has a stable austenite phase at less than 40.degree. C. and which is in a martensite phase when in a constricted configuration.

10. The device of claim 1 wherein at least one non-traumatic end is ball-shaped.

11. The device of claim 1 wherein at least one non-traumatic end comprises contoured wire.

12. The device of claim 11 wherein the contoured wire forms a sharp bend.

13. The device of claim 11 wherein the contoured wire forms a rounded bend.

14. The device of claim 11 wherein the contoured wire forms a coil.

15. The device of claim 11 wherein the contoured wire is flat.

16. The device of claim 1 wherein at least one non-traumatic end is textured.

17. The device of claim 1 wherein at least one non-traumatic end comprises a pad.

18. The device of claim 17 wherein the pad is molded.

19. The device of claim 17 wherein the pad is a mesh.

20. The device of claim 1 wherein at least one non-traumatic end is gripped.

21. The device of claim 1 wherein at least one expansive element is resilient.

22. The device of claim 1 additionally comprising a therapeutic substance on at least one expansive element.

23. The device of claim 22 wherein the therapeutic substance delivered by the device comprises a contraceptive.

24. The device of claim 22 wherein the therapeutic substance delivered by the device comprises a spermicidal agent.

25. The device of claim 22 wherein the therapeutic substance delivered by the device comprises an antimicrobial agent.

26. The device of claim 22 additionally comprising fibers on the expansive elements.

27. An occluding member for a patient's reproductive lumen, comprising: a. a first spider segment having a first expansive element having a first end secured to a central location in the occluding member and a non-traumatic end radially spaced from the first end when in an expanded configuration and, at least one additional expansive element having a first end secured to the central location in the occluding member and a non-traumatic end radially spaced from the central location in the expanded configuration; andb. a second spider segment axially spaced from the first spider segment, having a first expansive element having a first end secured to a central location in the occluding member and a non-traumatic end radially spaced from the first end when in an expanded configuration and at least one additional expansive element having a first end secured to the central location in the occluding member and a non-traumatic end radially spaced from the central location in the expanded configuration.

28. The occluding device of claim 27 wherein a connecting member extends interconnects the first spider segment with an adjacent spider segment.

29. The occluding device of claim 28 wherein the adjacent spider segment is the second spider segment.

30. The occluding device of claim 28 wherein the connecting member is straight.

31. The occluding device of claim 28 wherein the connecting member is curved.

32. The occluding device of claim 27 including at least one intermediate spider segment which is axially disposed between the first and second spider segments and which has: a first expansive element having a first end secured to a central location in the occluding member and a non-traumatic end radially spaced from the first end when in an expanded configuration and at least one additional expansive element having a first end secured to the central location in the occluding member and a non-traumatic end radially spaced from the first end when in the expanded configuration.

33. The occluding device of claim 30 wherein at least one connecting member extends between each spider segment and an adjacent spider segment.

34. The device of claim 30 wherein the first, second and intermediate spider segments are axially aligned.

35. The device of claim 30 wherein the spider segments are connected to adjacent spider segments by a connecting member which extends axially along a central location within the occluding member.

36. The device of claim 27 additionally comprising at least one extension member having a first extension member end and a free end, the first extension member end secured to the central location.

37. The device of claim 36 wherein the extension member comprises a coil.

38. The device of claim 36 wherein the free end is non-traumatic.

39. The device of claim 27 additionally comprising fibers inter-disposed between the spiders.

40. The device of claim 27 additionally comprising a therapeutic substance on at least one expansive element.

41. The device of claim 27 wherein at least one non-traumatic end is ball-shaped.

42. The device of claim 27 wherein at least one non-traumatic end comprises contoured wire.

43. A minimally invasive system for occluding a patient's reproductive body lumen, comprising: a. an elongated delivery catheter having a proximal end, a port in the proximal end, a distal end, a port in the distal end and an inner lumen extending between and in fluid communication with the ports in the proximal and distal ends of the guiding catheter; andb. an occluding member which is disposed within the inner lumen of the elongated guiding catheter and which is configured to expand when released within the patient's reproductive body lumen, wherein the occluding member has at least one spider segment having a first expansive element having a first end secured to a central location in the occluding member and a non-traumatic end radially spaced from the first end when in an expanded configuration and, at least one additional expansive element having a first end secured to the central location in the occluding member and a non-traumatic end radially spaced from the central location in the expanded configuration.

44. The occluding member of claim 43 wherein a connecting member extends interconnects the first spider segment with an adjacent spider segment.

45. The occluding member of claim 44 wherein the adjacent spider segment is the second spider segment.

46. The occluding member of claim 43 including at least one intermediate spider segment which is axially disposed between the first and second spider segments and which has: a first expansive element having a first end secured to a central location in the occluding member and a second end radially spaced from the first end when in an expanded configuration and at least one additional expansive element having a first end secured to the central location in the occluding member and a second end radially spaced from the first end when in the expanded configuration;

47. The system of claim 46 wherein the occluding device has at least one connecting member extending between each spider segment and an adjacent spider segment.

48. The system of claim 47 wherein the connecting member of the occluding member is straight.

49. The system of claim 47 wherein the connecting member of the occluding member is curved.

50. An occluding member for a patient's reproductive lumen, comprising: a brush element having a plurality of members with first ends and second ends, the first ends secured in a central location, the second ends radiating from the central location, wherein the second ends form a contour having at least one substantially circular cross section; andat least one non-traumatic element secured to at least one of the second ends

51. The device of claim 50 additionally comprising at least one additional brush element secured to an elongated connecting member, the elongated connecting member secured to the brush elements at the central locations.

52. The device of claim 50 wherein the second ends form a cylindrical contour.

53. The device of claim 51 wherein the elongated connecting member comprises a plurality of coiled wires.

54. The device of claim 51 additionally comprising an extension member having a first extension member end and a free end, the first extension member end secured to the central location.

55. An occluding member for a patient's reproductive lumen, comprising: a first member with a first end and a second end of the first member, the first end of the first member secured to a spring element;a second member with a first end and a second end of the second member, the first end of the second member secured to the spring element; andat least one non-traumatic element secured to at least one second end.

56. An occluding member for a patient's reproductive lumen, comprising: a plurality of inner-members with first inner-member ends and non-traumatic ends, the first inner-members ends being secured at a central location, the second inner-member ends extending axially and radially away from the central location, the second inner-member ends forming an expansive diameter.

57. The device of claim 56 additionally comprising a plurality of outer-members with first outer-member ends and non-traumatic ends, the first outer-member ends being secured to the second-inner member ends, the non-traumatic ends extending axially and radially towards the central location, the non-traumatic ends forming a second expansive diameter.

58. The device of claim 57 wherein the second expansive diameter is greater than the first expansive diameter.

59. An occluding member for a patient's reproductive lumen having at least one segment with a first contracted configuration and a second expanded configuration, comprising: a. a first expansive element having a first end and a non-traumatic end radially spaced from the first end when in an expanded configuration;b. at least one additional expansive element having a first end and a non-traumatic end radially spaced from the central location in the expanded configuration; andc. a means of connecting the first expansive element to an additional expansive element.

60. A method of expanding an occluding member in a patient's reproductive lumen, comprising: inserting an elongated delivery catheter containing the occluding member, the occluding member comprising a plurality of inner-members with first inner-member ends and second inner-member ends, the first inner-members ends being secured at a central location, the second inner-member ends extending axially and radially away from the central location, the second inner-member ends forming a first expansive diameter, anda plurality of outer-members with first outer-member ends and non-traumatic ends, the first outer-member ends being secured to the second-inner member ends, the non-traumatic ends extending axially and radially towards the central location, the non-traumatic ends forming a second expansive diameter into the patient's reproductive lumen, the reproductive lumen having a longitudinal axis, the reproductive lumen having an inner diameter; andreleasing the occluding member in the patient's reproductive lumen where the central location is substantially aligned with the longitudinal axis of the reproductive lumen and the second expansive diameter is substantially uniform to the inner diameter of the reproductive lumen.

61. A method of expanding an occluding member in a patient's reproductive lumen, comprising: inserting an elongated delivery catheter containing an occluding member, the occluding member comprising a means for occluding; andreleasing the occluding member in the patient's reproductive lumen.

62. The device of claim 27 additionally comprising a membrane inter-disposed between at least one of the spider segments.

63. The device of claim 1 wherein the first and additional expansive elements are configured into a flower petal segment.

64. The device of claim 1 additionally comprising at least one hydrogel element, which upon insertion in to the patient expands to block the lumen.

65. The device of claim 64 wherein the hydrogel element is porus to allow tissue ingrowth.

66. The device of claim 64 wherein the hydrogel element carries a contraceptive drug.

67. The device of claim 1, additionally comprising a marker string coupled to the central location.

68. The device of claim 1, additionally comprising a hydrophobic coating coupled to at least one of the expansive elements.

69. A method of delivering at least one occluding member to a patient's reproductive lumen without the use of a placement catheter, comprising: inserting a hysteroscope into the uterus, wherein the occluding member is disposed inside of the working channel of the hysteroscope; andpushing the occluding member into the reproductive lumen with a plunger device.

70. The method of claim 69, wherein the occluding member is at least partially coated with a hydrophilic coating.