Method and assembly for lung volume reduction

• US 6,599,311 B1
• Filed: 05/23/2000
• Issued: 07/29/2003
• Est. Priority Date: 06/05/1998
• Status: Expired due to Term

• Current Assignee: EKOS Corporation (Boston Scientific Corporation)
• Original Assignee: Broncus Technologies, Inc
• Inventors: Biggs, Michael, Masterson, Steven, Burger, Keith M., Ross, John Arthur, Loomas, Bryan, Davenport, James M., Haugaard, Dave
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/576,786
• Time in Patent Office: 1,162 Days
• Field of Search: 606/232, 606/149, 606/104, 623/23.64, 623/23.65
• US Class Current: 606/232
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00809 Lung operations
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0451 Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/1205 Introduction devices

Abstract

Methods and assemblies for reducing the volume of a lung. A plurality of anchors are anchored at different positions in the lung. A cord is attached to each of the anchors. The anchors are drawn towards one another via the cords to cause the lung to collapse, thus compressing the tissue in the lung and establishing a reduction in lung volume.

Claims

1. A lung volume reduction device comprising:

a) at least one anchor having a reduced profile and being configured to assume an expanded profile wherein in said reduced profile said anchor is capable of being advanced into an airway of the lung and in said expanded profile said anchor secures to lung tissue;

b) at least one connector;

c) at least one cord having a proximal end and a distal end, said proximal end being attached to at least one of said connectors which is adapted to be self-locking about said cord and said distal end being attached to at least one of said anchors; and

d) a delivery device being configured to removably seat at least one of said anchors on a distal end.

2. The lung volume reduction device of claim 1, wherein said connector comprises:

a) a body having at least one passageway sized to permit passage of the cord; and

b) a stop having at least a portion connected to each of said passageways said stop configured to prevent movement of the cord after the cord is fed through said passageway to a desired location.

3. The lung volume reduction device of claim 2 wherein said body is plastically deformable such that deformation of said body reduces a diameter of said passageway to create said stop.

4. The lung volume reduction device of claim 2 wherein said stop comprises at least one tapered plug having a first and second diameters and at least one ring having an inner diameter sized between said first and second diameters of said plug, said ring located co-axially with each of said passageways, wherein movement of the at least one cord may be prevented by passing the at least one cord through said ring and inserting said tapered plug into said ring.

5. The lung volume reduction device of claim 2 wherein said connector further comprises a tube slidably located within said passageway, said tube having a lumen sized to permit passage of the at least one cord, and wherein said stop comprises a plurality of stops, wherein upon removal of said tube from said passageway causes said stops to frictionally hold the cord.

6. The lung volume reduction device of claim 2 wherein said stop comprises a moveable section within said body, said moveable section having a hole sized to permit passage of the cord, said moveable section having an aligned position such that said hole is in alignment with said passageway which allows movement of the cord, and a non-aligned position such that said hole is not in alignment with said passageway which prevents movement of the cord.

7. The lung volume reduction device of claim 6 wherein said moveable section is biased to assume said non-aligned position.

8. The lung volume reduction device of claim 6 wherein said moveable section is retained in said aligned position by a removable tube extending through said passageway and said hole.

9. The lung volume reduction device of claim 2 wherein said stop comprises a section of reduced diameter in said passageway.

10. The lung volume reduction device of claim 9 further comprising a flange within said passageway, said flange having a plurality of slots radially extending from a central opening, wherein said center opening comprises said section of reduced diameter and is sized to permit movement of the cord and said slots are sized to prevent movement of the cord.

11. The lung volume reduction device of claim 9 wherein said stop further comprises a plug which seats in said section of reduced diameter to provide frictional resistance against the cord to prevent movement of the cord.

12. The lung volume reduction device of claim 11 wherein said plug is directionally biased towards said section of reduced diameter by a spring.

13. The lung volume reduction device of claim 11 wherein said plug comprises a spherical stop.

14. The lung volume reduction device of claim 13 wherein said connector comprises six passageways and said stop comprises six spherical stops.

15. The lung volume reduction device of claim 2 wherein said passageway further comprises a plurality of prongs extending away from said body towards a center of said passageway, said prongs configured to retain the proximal end of the cord or to interfere with the cord and hold it in place by frictional forces.

16. The lung volume reduction device of claim 2 for use with the lung reduction device additionally having a cord with a segment of increased diameter, wherein said stop of said connector comprises a stopper slidably located within said passageway and attached to said body by a spring element such that said stopper maintained in said passageway and is temporarily moveable out of a proximal end of said body, said stopper having a proximal diameter less than a diameter of said passageway, wherein after the segment of increased diameter of the cord is pulled from a distal end of said body through said proximal end of said body and past said stopper, said stopper prevents substantial movement of the cord in a distal direction.

17. The lung volume reduction device of claim 16 wherein a base of said distal end of said body comprises said spring element.

18. The lung volume reduction device of claim 16 wherein said stopper has a plug extending out of said proximal end of said body, wherein said plug is configured allow said stopper to be temporarily pulled out of said passageway to release the cord.

68. A lung volume reduction device kit comprising:

a) the lung volume reduction device of claim 1; and

b) a bronchoscope.

69. The lung volume reduction device kit of claim 68 further comprising a fibrosing agent.

70. The lung volume reduction kit of claim 68 further comprising a sclerosant.

71. The lung volume reduction device kit of claim 68 in which each instrument in the kit has been rendered sterile and been packaged to maintain sterility of the instruments.

72. A method for preparing the lung volume reduction device of claim 1 for use in a medical procedure comprising the steps of:

sterilizing the lung volume reduction device; and

packaging the lung volume reduction device.

19. An anchor for use with a lung volume reduction device having a connector joining said anchor to a second anchor, wherein said anchor comprises:

a central portion and an attachment portion connected to said central portion, said attachment portion being moveable between a reduced profile and an expanded profile, wherein when in said reduced profile said anchor is capable of being advanced into a passageway of the lung and when in said expanded profile said attachment portion attaches to lung tissue; and

at least one cord having a distal end and a proximal end, said distal end being attached to said central portion of said anchor and said proximal end secured to the connector which is adapted to be self-locking about said cord.

20. The anchor of claim 19 wherein said central portion comprises a wire having at least one loop, and said attachment portion comprises a first end and second end of said wire, where rotation of said anchor in the lung passageway permits said ends of said wire to contact the lung causing said anchor to assume said expanded profile.

21. The anchor of claim 19 wherein said anchor comprises a segment having a first and second end, wherein said central portion of said anchor is located between said first and second ends, said first end is configured to be atraumatic and said second end is configured to penetrate lung tissue, wherein rotation of said anchor in the lung passageway permits said ends to contact lung tissue causing said anchor to assume said expanded profile.

22. The anchor of claim 19 wherein said anchor comprises a flat spring, said ends of said spring comprising said attachment portion, said spring folded about a center point, said fold forming said central portion of said anchor, said spring further comprising barbs along a surface of said spring.

23. The anchor of claim 19 wherein said attachment portion comprises at least one tine, each said tine having a first end and a second end, said first end being attached to said central portion, wherein when said second ends of said tine move away from said central portion said anchor assumes said expanded profile.

24. The anchor of claim 23 further comprising a fibrosing agent on at least a surface of said anchor.

25. The anchor of claim 24 wherein said fibrosing agent is located adjacent to said tine of said anchor.

26. The anchor of claim 23 wherein each of said attachment portion is sized to enter an airway of less than 3 mm in approximate diameter.

27. The anchor of claim 23 wherein said attachment portion comprises three tines.

28. The anchor of claim 23 wherein said attachment portion comprises four tines.

29. The anchor of claim 23 wherein said second end of each said tine is configured to prevent movement of the anchor relative to the airway when said anchor is in said expanded profile.

30. The anchor of claim 23 wherein said anchor is configured to be atraumatic to the lung.

31. The anchor of claim 23 wherein each said tine is plastically deformable such that said anchor retains said expanded profile upon deformation of said tine.

32. The anchor of claim 23 wherein said anchor is mechanically deformable to assume said expanded profile.

33. The anchor of claim 23 wherein at least said tines comprises a shape-memory alloy and said anchor is thermally deformable to assume said expanded profile.

34. The anchor of claim 23 wherein said anchor is spring biased to assume said expanded profile.

35. The anchor of claim 23 wherein said cord further comprises a wedge attached to a distal end of said cord, said at least one tine comprises at least two of said tines, and said wedge being slidably attached to said anchor between at least two of said tines, when said wedge is proximate to said second end of said tines said anchor is in said reduced profile, and when said wedge slides towards said central portion of said anchor, said wedge displaces said tines so that said anchor assumes said expanded profile.

36. The anchor of claim 35 wherein said anchor further comprises at least one stop attached to at least one of said tines to fixedly attach said wedge adjacent to said central portion.

37. The anchor of claim 23 wherein said anchor further comprises at least one covering having a wall, said wall having a plurality of openings, said covering being placed over said central portion, said second end of said tine extending through said openings of said covering, wherein movement of said central portion within said covering advances or retracts said second end of said tine through said openings.

38. The anchor of claim 23 wherein said cord further includes a hook attached to said proximal end of said cord.

39. The anchor of claim 23 wherein said cord is elastic.

40. The anchor of claim 39 wherein said cord comprises a tube having a lumen.

41. The anchor of claim 23 wherein said cord comprises at least two segments each having different diameters.

42. The anchor of claim 41 wherein at least one of said segments comprises a ball-bearing fixedly attached to said cord.

43. A delivery device for use with a lung volume reduction device, wherein said delivery device comprises:

an elongate member having a distal and a proximal end, said elongate member being adapted to be advanced within airways of at least one lung, said elongated member being configured to removably seat the anchor on a distal end of the elongated member wherein said lung volume reduction device has at least one cord having a proximal end and a distal end, the distal end of the cord being attached to said anchor and the proximal end of the cord being attached to at least one connector which is adapted to be self-locking bout said cord.

44. The delivery device of claim 43 wherein said elongated member further comprises a fluid delivery port at a proximal end of said elongated member, a lumen extending between said proximal and distal ends of said elongated member, and a seal in said lumen at said proximal end, said seal configured to allow the cord to exit from said proximal end while keeping said lumen fluidly sealed at said proximal end.

45. The delivery device of claim 43 wherein at least said distal end of said elongated member is hollow and sized to seat the anchor.

46. The delivery device of claim 45 wherein said elongated member has at least two slots located at said distal end, each said slot being sized to allow a portion of the anchor to expand through said slot.

47. The delivery device of claim 43 wherein said distal end of said elongated member further comprises a tapered section, said distal end being configured so that retracting the anchor in a proximal direction over said tapered section causes the anchor to expand to assume the expanded profile.

48. The delivery device of claim 43 wherein said distal end comprises a compressible sleeve located between the anchor and the elongate member, compressing said sleeve in a lengthwise direction causes said sleeve to expand to an increased diameter, expansion of said sleeve to said increased diameter mechanically deforms the anchor to assume the expanded profile.

49. The delivery device of claim 43 further comprising a cutter configured to sever the cord.

50. The delivery device of claim 49 wherein said cutter is a suture cutter.

51. The delivery device of claim 49 wherein said cutter is a blade within said elongate member.

52. The delivery device of claim 49 wherein said cutter is a flexible rod having a sharpened end for cutting the cord.

53. The delivery device of claim 49 wherein said cutter comprises a first shearing surface and a second shearing surface.

54. The delivery device of claim 53 wherein said elongate member comprises said first shearing surface, and said second shearing surface is moveable within said elongate member such that the section of the cord between said first and second shearing surfaces is cut as said first and second shearing surfaces join.

55. The delivery device of claim 54 wherein said second shearing surface is configured to move at least axially within said elongate member.

56. The delivery device of claim 54 wherein said second shearing surface is configured to move at least torsionally within said elongate member.

57. The delivery device of claim 49 wherein said cutter comprises a heating element configured to melt the cord.

58. A method for minimally invasively or non-invasively treating a lung having at least an emphysematous portion comprising the step of improving a pulmonary function of at least a first portion of the lung by reducing a volume of a second portion of the lung while maintaining communication between the first portion and the second portion.

59. The method of claim 58 wherein the step of improving a pulmonary function of at least the first portion of the lung comprises reducing hyperinflation of the second portion of the lung.

60. The method of claim 58 wherein the step of improving a pulmonary function of at least the first portion of the lung comprises increasing the range of motion of the diaphragm.

61. The method of claim 58 wherein the step of improving a pulmonary function of at least the first portion of the lung comprises redirecting airflow to a healthier portion of the lung.

62. The method of claim 58 wherein the step of reducing the volume of the second portion of the lung comprises removing non-functional residual air from the lung.

63. The method of claim 58 wherein the step of improving a pulmonary function of at least the first portion of the lung comprises the steps of

attaching a first anchor to the lung;

attaching a second anchor to lung,

connecting a cord between the second anchor and the first anchor; and

shortening the length of the cord between the first and second anchors to compress the second portion of the lung.

64. The method of claim 63 further comprising the step of deflating at least a portion of the lung prior to said shortening step.

65. The method of claim 63 further comprising the step of injecting a sclerosant agent in the second portion of the lung to maintain the compression of the second portion.

66. The method of claim 63 wherein the first anchor and the second anchor each have separate cords, and said connecting step uses a connector to connect the cords of each anchor.

67. The method of claim 63 further comprising the step of placing at least one support member in the lung to create an area of improved anchor support for increasing the anchoring ability of at least one of the anchors.