Biological tissue closure device and method

• US 20060009802A1
• Filed: 07/10/2004
• Published: 01/12/2006
• Est. Priority Date: 07/10/2004
• Status: Active Grant

• Current Assignee: Arstasis, Inc.
• Original Assignee: Arstasis, Inc.
• Inventors: Modesitt, D. Bruce
• Granted Patent: US 7,678,133 B2
• Time in Patent Office: Days
• US Class Current: 606/215
• 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 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2018/0063 Sealing
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

Devices and methods for biological tissue closure are disclosed. Arteriotomy closure and hemostasis devices and methods are disclosed. A device that can provide a lateral tension across an opening in the tissue and apply energy to seal the tissue is disclosed. Methods for using the device are also disclosed.

Claims

27. A vascular closure device using energy to create a hemostatic seal, wherein the device is configured to deliver energy to an arteriotomy, and wherein the device is configured to precisely aim the energy at the arteriotomy.

28. A device for closing an opening in biological tissue, wherein the opening has an internal wall, comprising:

a wall manipulator, wherein the wall manipulator is configured to bring a first part of the wall adjacent to a second part of the wall; and

a seal applier.

29. A device for closing an opening in biological tissue, comprising:

a delivery guide having a longitudinal axis with a distal direction and a proximal direction;

two expander wires having distal ends, wherein the expander wires have a retracted configuration and an expanded configuration; and

a pressure check port;

wherein the pressure check port is distal to, or aligned with, the distal ends when the expander wires are in a retracted configuration.

30. A device for closing an opening in biological tissue, comprising:

A first elongated member; and

A second elongated member, wherein the first elongated member and the second elongated members are configured to laterally expand the opening.

1. A device for closing an opening in biological tissue, comprising:

a tensioner, wherein the tensioner is configured to tension the opening; and

a seal applier.

2. The device of claim 1, wherein the tensioner comprises a first elongated member and a second elongated member.

3. The device of claim 2, wherein the first elongated member is configured to bias away from the second elongated member.

4. The device of claim 3, wherein the second elongated member is configured to bias away from the first elongated member.

5. The device of claim 2, wherein the elongated members comprise wires.

6. The device of claim 2, wherein one or more elongated members comprise the seal applier.

7. The device of claim 6, wherein the seal applier comprises an energy transducer.

8. The device of claim 6, wherein the energy transducer comprises one or more RF transducers.

9. The device of claim 1, wherein the seal applier comprises an RF transducer.

10. The device of claim 1, wherein the seal applier comprises an acoustic transducer.

11. The device of claim 1, wherein the seal applier comprises an microwave transducer.

12. The device of claim 1, wherein the seal applier comprises a heater.

13. The device of claim 12, wherein the heater comprises an inductive heater.

14. The device of claim 12, wherein the heater comprises a resistive heater.

15. The device of claim 12, wherein the heater comprises a microwave heater.

16. The device of claim 1, wherein the seal applier comprises a hole.

17. The device of claim 16, wherein the hole comprises a microscopic pore.

18. The device of claim 1, wherein the seal applier comprises a web.

19. The device of claim 18, wherein the web comprises a first fiber and a second fiber.

20. The device of claim 19, wherein the first fiber crosses the second fiber.

21. The device of claim 18, wherein the web comprises a bioabsorbable material.

22. The device of claim 18, wherein the web comprises a conductive material.

23. The device of claim 18, wherein the web comprises a conductive polymer.

24. The device of claim 18, wherein the web comprises an inductively heated material.

25. The device of claim 18, wherein the web is removably attached to the device.

26. The device of claim 1, wherein the opening comprises an arteriotomy in a biological vessel.

31. The device of claim 30, wherein the first elongated member is configured to apply a first force in a first direction against the opening, and wherein the second elongated member is configured to apply a second force in a second direction against the opening, and wherein the first direction is substantially opposite to the second direction.

31-1. The device of claim 30, wherein the opening is an arteriotomy.

32. A method for closing an opening in a biological tissue, wherein the opening has an internal wall, comprising:

tensioning the opening; and

applying a sealer to the opening.

33. The method of claim 33, wherein tensioning comprises bringing a first part of the wall adjacent to a second part of the wall.

38. The method of claim 33, wherein the sealer comprises energy.

39. The method of claim 38, wherein the energy comprises acoustic energy.

40. The method of claim 39, wherein the energy further comprises RF energy.

41. The method of claim 38, wherein the energy comprises RF energy.

42. The method of claim 38, wherein the energy comprises conductive heat energy.

43. The method of claim 38, wherein the energy comprises inductive heat energy.

44. The method of claim 38, wherein the energy comprises microwave heat energy.

45. The method of claim 33, wherein the sealer comprises an adhesive.

46. The method of claim 33, wherein the sealer comprises a filler.

47. The method of claim 33, wherein the sealer comprises a liquid.

48. The method of claim 45, wherein the adhesive comprises a liquid adhesive.

49. The method of claim 33, further comprising aiming the sealer at the opening.

50. The method of claim 49, wherein aiming comprises deploying an aiming device into the opening.

51. The method of claim 33, further comprising deploying a web into the opening.

52. The method of claim 51, wherein deploying comprises leaving the web in the opening at least for an extended period following closing the opening.

53. The method of claim 52, wherein deploying comprises leaving the web in the opening at least until the web is entirely bioabsorbed.

54. The method of claim 33, wherein the opening is an arteriotomy.

55. The method of claim 33, further comprising inserting a hollow member into the opening, and further performing a first surgical procedure through the hollow member, and wherein tensioning then is performed with the hollow member.

35. The method of claim 34, wherein the first part of the wall is brought to less than about 0.51 mm away from the second part of the wall.

36. The method of claim 35, wherein the first part of the wall is brought to less than about 0.38 mm away from the second part of the wall.

37. The method of claim 36, wherein the first part of the wall is brought to more than about 0.25 mm away from the second part of the wall.

56. A method for closing an opening in a biological tissue, wherein the opening has an internal wall, comprising:

bringing a first part of the wall adjacent to a second part of the wall; and

applying a sealer to the opening.

57. The method of claim 56, wherein the first part of the wall is brought to less than about 0.51 mm away from the second part of the wall.

58. The method of claim 57, wherein the first part of the wall is brought to less than about 0.38 mm away from the second part of the wall.

59. The method of claim 58, wherein the first part of the wall is brought to more than about 0.25 mm away from the second part of the wall.

60. A method for closing a subcutaneous opening in a biological tissue, comprising:

locating the opening; and

transmitting a first energy to the opening, wherein transmitting the first energy comprises transmitting from outside of the surface of the skin.

61. The method of claim 60, wherein the first energy comprises acoustic energy.

62. The method of claim 60, wherein transmitting comprises delivering the first energy from more than one source.

63. The method of claim 62, wherein transmitting comprises transmitting from a phased array source.

64. The method of claim 60, further comprising applying a sealer to the opening, wherein the sealer is applied from a closure device located subcutaneously.

65. The method of claim 64, wherein the sealer comprises a second energy.

66. The method of claim 65, wherein the second energy comprises RF energy.

67. The method of claim 65, wherein the second energy comprises acoustic energy.

68. The method of claim 65, wherein the second energy comprises conductive heat.

69. The method of claim 65, wherein the second energy comprises microwave energy.

70. A method for closing a subcutaneous opening in a biological vessel, comprising:

inserting in a first direction a closure device into the vessel, wherein the closure device comprises a pressure check port;

detecting fluid pressure across the pressure check port;

removing in a second direction the closure device from the vessel, wherein the second direction is substantially opposite to the first direction;

steadying the closure device after not detecting fluid pressure.

71. The method of claim 70, further comprising expanding the opening.

72. The method of claim 71, wherein expanding the opening comprises laterally expanding the opening.

73. The method of claim 70, wherein detecting comprises visually detecting fluid flow.

74. The method of claim 70, wherein fluid flow comprises fluid flow outside of proximal end of the closure device.

75. A method for closing an opening in biological tissue, comprising:

inserting a first elongated member into the opening;

inserting a second elongated member into the opening;

expanding the opening, wherein expanding comprises applying a force on the opening with the first and second elongated members to expand the opening.

76. The method of claim 75, wherein expanding comprises laterally expanding the opening.

77. The method of claim 75, wherein the first elongated member applies a first force in a first direction against the opening, and wherein the second elongated member applies a second force in a second direction against the opening, and wherein the first direction is substantially opposite to the second direction.

78. The method of claim 75, wherein the opening is an arteriotomy.