Methods and devices for tissue reconfiguration

• US 6,663,639 B1
• Filed: 03/07/2000
• Issued: 12/16/2003
• Est. Priority Date: 06/22/1999
• Status: Expired due to Term

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: NDO Surgical, Inc.
• Inventors: Cerier, Jeffrey C., Laufer, Michael D., Cruz, Amos G.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/520,273
• Time in Patent Office: 1,379 Days
• Field of Search: 606/139, 128/898, 227/175.1
• US Class Current: 606/139
• 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 17/0057 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 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 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• 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 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/0475 : using sutures having a slip knot
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/061 : hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/0647 : having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 : Coils or spirals
• CPC Class Codes: A61B 2017/2905 : flexible
• CPC Class Codes: A61B 2017/2915 : arcuate shaped guiding means
• CPC Class Codes: A61B 2017/2916 : pins in guiding slots
• CPC Class Codes: A61B 2017/2917 : with flexible part
• CPC Class Codes: A61B 2017/2927 : the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61M 25/0133 : Tip steering devices

Abstract

Methods and devices are provided for reconfiguring a tissue within a hollow body organ using an entirely endoscopic approach in order to effectively reduce flow of fluid contents into a second hollow body organ in fluid communication with the first.

Claims

1. An endoscopic method of reconfiguring tissue within a first hollow organ of a subject, wherein the first hollow organ has an inner surface, an outer surface, a lumen defined by the inner surface, and at least one junction connecting the first hollow organ in fluid communication with a second hollow organ, the method comprising:

simultaneously engaging at least two portions of at least the inner surface of the first hollow organ;

manipulating at least one of the engaged portions of the first hollow organ to create a reconfigured portion of the first hollow organ from within; and

permanently securing the reconfigured portion of the first hollow organ with at least one tissue fixation device so as to substantially retain the shape of the reconfigured portion;

wherein securing the reconfigured portion of the first hollow organ does not involve securing the reconfigured portion of the first hollow organ to tissue of the second hollow organ.

2. The method of claim 1 wherein any one or combination of the engaging, manipulating and securing steps is repeated at least once.

3. The method of claim 1 further comprising endoscopic visualization of at least a portion of at least one of the steps of engaging, manipulating, and securing.

4. The method of claim 1 wherein the permanently secured reconfigured portion comprises a conformation selected from the group consisting of a bulge, a mound, a plication, a ridge, a jellyroll, a tube, a cone, and a horn.

5. The method of claim 1 wherein the permanently secured reconfigured portion comprises a tissue fold.

6. The method of claim 1 wherein the permanently secured reconfigured portion comprises a tissue bulge.

7. The method of claim 1 wherein the engaging is reversible and essentially atraumatic.

8. The method of claim 1 wherein the engaging comprises clamping.

9. The method of claim 1 wherein the engaging comprises applying a corkscrew-like retractor to at least the inner surface of the first hollow organ.

10. The method of claim 1 wherein the securing comprises application of a biocompatible tissue fixation device selected from the group consisting of a staple, a clip, a tack, a rivet, a two-part fastener, a helical fastener, a suture, and a T-bar suture.

11. The method of claim 1 wherein the securing involves only tissue of the first hollow organ.

12. The method of claim 1 wherein the securing comprises stapling.

13. The method of claim 1 wherein the securing comprises application of a two-part fastener.

14. The method of claim 1 wherein the engaging and the securing are performed using a single instrument.

15. The method of claim 1 wherein the first hollow organ is selected from the group consisting of esophagus, stomach, intestine, bladder, ureter, urethra, uterus, vagina, heart, and vein.

16. The method of claim 1 wherein the permanently secured reconfigured portion is effective to reduce flow of contents of the first hollow organ into the second hollow organ.

17. An endoscopic method for treating gastroesophageal reflux in a subject comprising:

simultaneously engaging at least two independent points of at least the inner surface of the stomach of a subject, near an opening of the esophagus of the subject into the stomach;

manipulating at least one of the engaged points of the stomach to create a reconfigured portion of the stomach from within; and

permanently securing the reconfigured portion of the stomach with at least one tissue fixation device so that the shape of the reconfigured portion is retained,

wherein the steps of engaging, manipulating, and securing are all performed endoluminally.

18. The method of claim 17 wherein any one or combination of the engaging, manipulating, and securing is repeated at least once.

19. The method of claim 17 wherein the engaging, manipulating, and securing are performed at a time of making an endoscopic diagnosis of GERD.

20. The method of claim 17 wherein the permanently secured reconfigured portion comprises a conformation selected from the group consisting of a bulge, a mound, a plication, a ridge, a jellyroll, a tube, a cone, and a horn.

21. The method of claim 17 wherein the permanently secured reconfigured portion comprises a tissue fold.

22. The method of claim 17 wherein the permanently secured reconfigured portion comprises a tissue bulge.

23. The method of claim 17 wherein the engaging is reversible and essentially atraumatic.

24. The method of claim 17 wherein the engaging comprises clamping.

25. The method of claim 17 wherein the engaging comprises applying a corkscrew-like retractor to at least the inner surface of the stomach.

26. The method of claim 17 wherein the securing comprises application of a biocompatible tissue fixation device selected from the group consisting of a staple, a clip, a tack, a rivet, a two-part fastener, a helical fastener, a suture, and a T-bar suture.

27. The method of claim 17 wherein the securing comprises stapling.

28. The method of claim 17 wherein the securing comprises application of a two-part fastener.

29. The method of claim 17 wherein the engaging and the securing are performed using a single instrument.

30. The method of claim 17 further comprising measuring tissue pressure at the GEJ in association with at least one of the steps of engaging, manipulating, and securing.

31. The method of claim 17 further comprising measuring yield pressure in association with at least one of the steps of engaging, manipulating, and securing.

32. The method of claim 17 wherein the permanently secured reconfigured portion is effective to increase yield pressure by an amount effective to reduce passage of gastric contents from the stomach to the esophagus.

33. The method of claim 17 wherein the permanently secured reconfigured portion is effective to reduce reflux of gastric contents into the subject'"'"'s esophagus.

34. The method of claim 17 wherein the permanently secured reconfigured portion is effective to reduce symptoms related to gastroesophageal reflux.

35. The method of claim 17 wherein said manipulating step comprises moving the points toward each other to create the tissue bulge.

36. The method of claim 17 wherein said engaging step comprises the step of engaging the two points adjacent to a flap portion of an existing flap valve, the two points straddling the flap portion of the flap valve and on the same side of the opening.

37. The method of claim 36 wherein said manipulating step comprises moving the two points toward one another to create a bulge that displaces the flap portion toward the opening of the esophagus into the stomach.

94. The method of claim 17 wherein the manipulating is effective to bring sealing surfaces of an existing flap valve into a closer approximation.

38. An endoscopic method for treating gastroesophageal reflux in a subject comprising:

engaging at least the inner surface of the stomach at at least one portion near an opening of the esophagus of the subject into the stomach on one side of the opening of the esophagus into the stomach;

manipulating the at least one engaged portion of the stomach to create a reconfigured portion of the stomach comprising a flap portion of a flap valve including moving tissue of the inner surface of the stomach that is engaged at the at least one portion on one side of the opening of the esophagus into the stomach in said engaging step toward an opposite side of the opening of the esophagus into the stomach to form a flap; and

permanently securing the reconfigured portion of the stomach with at least one tissue fixation device so that the shape of the reconfigured portion is retained,

wherein the steps of engaging, manipulating, and securing are all performed endoscopically.

39. The method of claim 38 wherein any one or combination of the engaging, manipulating, and securing is repeated at least once.

40. The method of claim 38 wherein the reconfigured portion comprises an augmented gastroesophageal flap valve.

41. The method of claim 38 wherein the reconfigured portion comprises a new gastroesophageal flap valve.

42. The method of claim 38 wherein the engaging is reversible and essentially atraumatic.

43. The method of claim 38 wherein the engaging comprises clamping.

44. The method of claim 38 wherein the engaging comprises applying a corkscrew-like retractor to at least the inner surface of the stomach.

45. The method of claim 38 wherein the securing comprises application of a biocompatible tissue fixation device selected from the group consisting of a staple, a clip, a tack, a rivet, a two-part fastener, a helical fastener, a suture, and a T-bar suture.

46. The method of claim 38 wherein the securing comprises stapling.

47. The method of claim 38 wherein the securing comprises application of a two-part fastener.

48. The method of claim 38 wherein the engaging and the securing are performed using a single instrument.

49. The method of claim 38 further comprising measuring tissue pressure at the GEJ in association with at least one of the steps of engaging, manipulating, and securing.

50. The method of claim 38 further comprising measuring yield pressure in association with at least one of the steps of engaging, manipulating, and securing.

51. The method of claim 38 wherein the securing does not involve tissue of the subject'"'"'s esophagus.

52. The method of claim 38 wherein the flap valve is effective to increase competence of the GEJ by an amount effective to reduce passage of gastric contents from the stomach to the esophagus.

53. The method of claim 38 wherein the flap valve is effective to reduce symptoms related to gastroesophageal reflux.

54. The method of claim 38 wherein said permanently securing step comprises the step of applying at least one tissue fixation device to the flap formed by said manipulating step at a point on the side of the opening of the esophagus into the stomach opposite the side of tissue engagement.

55. An endoscopic method for treating gastroesophageal reflux in a subject comprising:

engaging at least one portion of at least the inner surface of the stomach of a subject, near an opening of the esophagus of the subject into the stomach;

manipulating at least one engaged portion of the stomach to create a reconfigured portion of the stomach comprising a flap portion of a flap valve and bringing sealing surfaces of the flap valve into closer approximation; and

permanently securing the reconfigured portion of the stomach with at least one tissue fixation device so that the shape of the reconfigured portion is retained and is effective for reducing gastroesophageal reflux,

wherein the steps of engaging, manipulating, and securing are all performed endoluminally.

56. The method of claim 55 wherein any one or combination of the engaging, reconfiguring, and securing is repeated at least once.

57. The method of claim 55 further comprising endoscopic visualization of at least a portion of at least one of the steps of engaging, reconfiguring, and securing.

58. The method of claim 55 wherein the engaging, reconfiguring, and securing are performed at the time of making an endoscopic diagnosis of GERD.

59. The method of claim 55 wherein the engaging is reversible and essentially atraumatic.

60. The method of claim 55 wherein the engaging comprises clamping.

61. The method of claim 55 wherein the engaging comprises applying a corkscrew-like retractor to at least the inner surface of the stomach.

62. The method of claim 55 wherein the securing comprises application of a biocompatible tissue fixation device selected from the group consisting of a staple, a clip, a tack, a rivet, a two-part fastener, a helical fastener, a suture, and a T-bar suture.

63. The method of claim 55 wherein the securing comprises stapling.

64. The method of claim 55 wherein the securing comprises application of a two-part fastener.

65. The method of claim 55 wherein the engaging and the securing are performed using a single instrument.

66. The method of claim 55 further comprising measuring tissue pressure at the GEJ in association with at least one of the steps of engaging, manipulating, and securing.

67. The method of claim 55 further comprising measuring yield pressure in association with at least one of the steps of engaging, manipulating, and securing.

68. The method of claim 55 wherein the securing involves only tissue of the stomach.

69. The method of claim 55 wherein the permanently secured reconfigured portion is effective to increase yield pressure of the GEJ of the subject by an amount effective to reduce flow of contents of the stomach into the esophagus of the subject.

70. The method of claim 55 wherein the permanently secured reconfigured portion is effective to reduce symptoms related to reflux of contents of the stomach into the esophagus of the subject.

71. The method of claim 70 wherein the symptoms related to reflux are reduced by at least 50 percent compared to the symptoms in the absence of the permanently secured reconfigured portion.

72. The method of claim 55 wherein said engaging step comprises the steps of:

deploying into the stomach of a subject at least two spaced, tissue engaging elements;

positioning the tissue engaging elements adjacent to and on one side of the opening of the esophagus into the stomach; and

engaging stomach tissue with the tissue engaging elements.

73. The method of claim 72 wherein said reconfiguring step comprises the steps of:

while the tissue engaging elements are engaging tissue in the stomach, moving at least two-spaced tissue engaging elements toward an opposite side of the opening of the esophagus into the stomach to create a pair of evaginations straddling the opening of the esophagus into the stomach.

74. The method of claim 73 wherein said permanently securing step comprises the step of securing the two evaginations to one another by passing a fixation device from the inside of one evagination into a wall of the other evagination.

75. The method of claim 74 further comprising the step of capturing an aspect of an extrinsic tissue structure between the two evaginations.

76. The method of claim 75 wherein the extrinsic tissue structure comprises a median arcuate ligament of a diaphragm.

77. A method for treating gastroesophageal reflux in a subject comprising:

engaging at least two portions of at least the inner surface of the stomach of a subject, the two portions being spaced from one another and disposed near an opening of the esophagus of the subject into the stomach;

reconfiguring at least a portion of the stomach to assume a new shape by bringing the engaged portions toward one another; and

permanently securing the reconfigured portion of the stomach with at least one tissue fixation device so as to retain the shape of the reconfigured portion.

78. The method of claim 77 wherein the steps of engaging, reconfiguring, and securing are performed endoscopically.

79. The method of claim 77 wherein the at least two portions spaced from one another are engaged by at least two distinct tissue engaging devices.

80. The method of claim 77 wherein the engaging is reversible and essentially atraumatic.

81. The method of claim 77 wherein the engaging comprises clamping.

82. The method of claim 77 wherein the engaging comprises application of a corkscrew-like retractor.

83. The method of claim 77 wherein the shape assumed by the reconfigured portion comprises a plication.

84. The method of claim 77 wherein the shape assumed by the reconfigured portion comprises a bulge.

85. The method of claim 77 wherein the shape assumed by the reconfigured portion is effective for bringing sealing surfaces at an opening of the esophagus into the stomach into closer apposition.

86. The method of claim 77 wherein the securing comprises stapling.

87. The method of claim 77 wherein the securing comprises application of a two-part fastener.

88. The method of claim 77 further comprising measuring tissue pressure at the GEJ in association with at least one of the steps of engaging, reconfiguring, and securing.

89. The method of claim 77 further comprising measuring yield pressure in association with at least one of the steps of engaging, reconfiguring, and securing.

90. An endoscopic method for treating gastroesophageal reflux in a subject comprising:

engaging first and second points on a side of an opening of the esophagus of a subject into the stomach, wherein the first point is disposed adjacent to a flap portion of the existing flap valve and the second point is disposed on a side of the opening of the esophagus into the stomach opposite the flap portion;

manipulating at least one engaged portion of the stomach to create a reconfigured portion effective to bring sealing surfaces of the existing flap valve into a closer approximation; and

permanently securing the reconfigured portion of the stomach with at least one tissue fixation device so that the shape of the reconfigured portion is retained,

wherein the steps of engaging, manipulating, and securing are all performed endoscopically.

91. The method of claim 90 wherein said manipulating step comprises moving the two points toward one another to create a bulge that displaces the flap portion towed the opening of the esophagus into the stomach.

92. An endoscopic method for treating gastroesophageal reflux in a subject comprising:

engaging at least the inner surface of the stomach at first and second points near an opening of the esophagus of the subject into the stomach on a first side of the opening of the esophagus into the stomach, wherein the first point is disposed adjacent to a flap portion of the existing flap valve and the second point is disposed on a side of the opening of the esophagus into the stomach opposite the flap portion;

engaging at least the inner surface of the stomach at first and second additional points on a second side of the opening of the esophagus into the stomach, wherein the first additional point is disposed adjacent to the flap portion of the existing flap valve and the second additional point is disposed on a side of the opening of the esophagus into the stomach opposite the flap portion;

manipulating at least one engaged portion of the stomach to create a reconfigured portion effective to bring sealing surfaces of an existing flap valve into a closer approximation; and

permanently securing the reconfigured portion of the stomach with at least one tissue fixation device so that the shape of the reconfigured portion is retained,

wherein the steps of engaging, manipulating, and securing are all performed endoscopically.

93. The method of claim 92 wherein said manipulating step comprises the steps of:

moving together the first and second points on the first side of the opening of the esophagus into the stomach; and

moving together the first and second additional points on the second side of the opening of the esophagus into the stomach.