DEVICES, METHODS, AND KITS FOR FORMING TRACTS IN TISSUE

• US 20100016786A1
• Filed: 07/21/2009
• Published: 01/21/2010
• Est. Priority Date: 07/21/2008
• Status: Active Grant

• Current Assignee: Arstasis, Inc.
• Original Assignee: Arstasis, Inc.
• Inventors: MODESITT, D. Bruce, DREWS, Michael
• Granted Patent: US 8,979,882 B2
• Time in Patent Office: Days
• US Class Current: 604/22
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61M 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32

Abstract

Described here are methods and devices for forming tracts in tissue. Some of the devices comprise an elongate member, a suction member coupled to a distal portion of the elongate member, and a tissue-piercing member slidably housed within the elongate member for forming a tract in tissue. Other devices comprise more than one suction member. Methods for forming tracts in tissue are also described here. In some methods, a device is advanced adjacent tissue, where the device comprises one or more suction members and a tissue-piercing member. Suction is applied so that the tissue is drawn against the one or more suction members, and a tissue-piercing member is advanced in a first direction through the drawn tissue to form a tract in or through the tissue. Kits incorporating one or more of the devices described here, in conjunction with one or more tools or the like, are also described here.

Claims

1. A device for forming a tract in tissue comprising:

an elongate member;

a suction member coupled to a distal portion of the elongate member; and

a tissue-piercing member slidably housed within the elongate member for forming a tract in tissue.

2. The device of claim 1, wherein the elongate member is flexible.

3. The device of claim 1, wherein the suction member is coupled to the elongate member via a flexible portion.

4. The device of claim 3, wherein the flexible portion is a hinge.

5. The device of claim 1, wherein the elongate member is articulatable.

6. The device of claim 1, wherein the tissue-piercing member is articulatable.

7. The device of claim 1, wherein the suction member is articulatable.

8. The device of claim 1, wherein the suction member has one or more tissue apposition members thereon.

9. The device of claim 8, wherein the tissue apposition member is a rib.

10. The device of claim 1, further comprising one or more sensors.

11. The device of claim 1, wherein the tissue-piercing member is a needle.

12. The device of claim 11, wherein the needle is hollow.

13. The device of claim 1, wherein the suction member is connected to a vacuum source.

14. The device of claim 1, wherein the elongate member has one or more lumens therethrough.

15. A device for forming a tract in tissue comprising:

an elongate member;

a first suction member coupled to a distal portion of the elongate member, and positionable against tissue;

a second suction member opposed to the first suction member; and

a tissue-piercing member for forming a tract in tissue.

16. The device of claim 15, wherein the tissue-piercing member is slidably housed within the elongate member.

17. The device of claim 15, wherein the first and second suction members are coupled together.

18. The device of claim 17, wherein the first and second suction members are coupled together via a flexible portion.

19. The device of claim 18, wherein the flexible portion is a hinge.

20. The device of claim 15, wherein the first and second suction members are movable relative to one another.

21. The device of claim 15, wherein the tissue-piercing member is a needle.

22. A method for forming a tract in tissue comprising:

advancing a device adjacent tissue, wherein the device comprises one or more suction members and a tissue-piercing member;

applying suction so that the tissue is drawn against the one or more suction members; and

advancing the tissue-piercing member in a first direction through the drawn tissue, to form a tract in the tissue.

23. The method of claim 22, further comprising articulating the tissue-piercing member.

24. The method of claim 23, further comprising advancing the tissue-piercing member in a second direction.

25. The method of claim 22, wherein the device further comprises one or more sensors and the method further comprises sensing at least one useful parameter.

26. The method of claim 25, wherein the parameter is selected from the group consisting of temperature, pressure, blood flow within a vessel, and combinations thereof.

27. The method of claim 22, wherein the tissue comprises an organ.

28. The method of claim 27, wherein the organ is selected from the group consisting of an organ of the cardiovascular system, an organ of the digestive system, an organ of the respiratory system, an organ of the excretory system, an organ of the reproductive system, and an organ of the nervous system.

29. The method of claim 28, wherein the organ is an organ of the cardiovascular system.

30. The method of claim 29, wherein the organ is an artery.

33. The method of claim 22, further comprising advancing one or more tools through the tract.

34. The method of claim 22, wherein the tissue-piercing member enters the tissue at a first location, and exits the tissue at a second location, wherein the length between the first location and the second location is greater than the thickness of the tissue.

35. The method of claim 22, wherein the length of the tract is greater than the thickness of the tissue.

36. The method of claim 22, wherein the tract self-seals.

37. The method of claim 36, wherein the tract seals within 15 minutes or less.

38. The method of claim 36, wherein the tract seals within 5 minutes or less.

39. The method of claim 36, wherein the tract seals within 1 minute or less.

31. The method of 22, further comprising withdrawing the tissue-piercing member from the tissue, wherein the tract seals after the tissue-piercing member has been withdrawn.

32. The method of claim 31, wherein the tract seals within 12 minutes or less.

40. A method comprising:

forming a tract in tissue by advancing a first tissue-piercing member in a first direction through the tissue,

wherein formation of the tract requires advancement of only the first tissue-piercing member through the tissue, and wherein the tract is self-sealing.

41. The method of claim 40, wherein the first tissue-piercing member comprises a needle.

42. The method of claim 40, further comprising advancing a device comprising the first tissue-piercing member adjacent to the tissue prior to advancing the first tissue-piercing member through the tissue.

43. The method of claim 42, wherein the device further comprises one or more suction members.

44. The method of claim 43, further comprising applying suction to the tissue to draw the tissue against the one or more suction members.

45. The method of claim 44, wherein the first tissue-piercing member is advanced in the first direction through the drawn tissue.

46. The method of claim 40, further comprising applying suction to the tissue to position the tissue.

47. The method of claim 46, wherein the tract is formed in the tissue after the tissue has been positioned by the application of suction.

48. The method of claim 40, wherein the tissue comprises an organ.

49. The method of claim 48, wherein the organ is selected from the group consisting of an organ of the cardiovascular system, an organ of the digestive system, an organ of the respiratory system, an organ of the excretory system, an organ of the reproductive system, and an organ of the nervous system.

50. The method of claim 40, wherein the tissue comprises a vessel.

51. The method of claim 50, wherein the tissue comprises an artery, and the tract is an arteriotomy.

52. The method of claim 40, further comprising rotating the tissue.

53. The method of claim 52, further comprising advancing the first tissue-piercing member through the rotated tissue.

54. The method of claim 40, further comprising withdrawing the first tissue-piercing member from the tissue, wherein the tract seals after the first tissue-piercing member has been withdrawn.

55. The method of claim 54, wherein the tract seals within 15 minutes or less.

56. The method of claim 54, wherein the tract seals within 5 minutes or less.

57. The method of claim 54, wherein the tract seals within 1 minute or less.

58. The method of claim 40, further comprising advancing one or more tools through the tract.

59. A method for forming a tract in tissue comprising:

advancing a tissue-piercing member in a first direction through the tissue to form a single tract in the tissue,

wherein the single tract is self-sealing.

60. The method of claim 59, wherein the tissue comprises a vessel.

61. The method of claim 60, wherein the tissue comprises an artery, and the tract is an arteriotomy.

62. The method of claim 59, further comprising withdrawing the tissue-piercing member from the tissue, wherein the tract seals after the tissue-piercing member has been withdrawn.

63. The method of claim 62, wherein the tract seals within 15 minutes or less.

64. The method of claim 62, wherein the tract seals within 5 minutes or less.

65. The method of claim 62, wherein the tract seals within 1 minute or less.

66. A method for forming a tract in tissue comprising:

advancing a device adjacent tissue, wherein the device comprises at least one tissue-piercing member; and

forming a tract in the tissue by advancing the at least one tissue-piercing member through the tissue,

wherein formation of the tract requires advancement only of the at least one tissue-piercing member through the tissue, and wherein the tract is self-sealing.

67. The method of claim 66, wherein the tissue comprises a vessel.

68. The method of claim 67, wherein the tissue comprises an artery, and the tract is an arteriotomy.

69. The method of claim 66, further comprising withdrawing the at least one tissue-piercing member from the tissue, wherein the tract seals after the at least one tissue-piercing member has been withdrawn.

70. The method of claim 69, wherein the tract seals within 15 minutes or less.

71. The method of claim 69, wherein the tract seals within 5 minutes or less.

72. The method of claim 69, wherein the tract seals within 1 minute or less.