Devices and methods for fastening tissue layers

• US 7,083,630 B2
• Filed: 08/29/2002
• Issued: 08/01/2006
• Est. Priority Date: 08/29/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: DiMatteo, Kristian, DiCesare, Paul, Shaw, William J., Gutelius, Patrick, Sullivan, Roy H., Buess, Gerhard F., Kalanovic, Daniel, Griego, John, Schurr, Marc O., Tassy, Marc Jr., DeVries, Robert
• Primary Examiner(s): Woo, Julian W.
• Application Number:
  US10/230,682
• Publication Number:
  US 20040087976A1
• Time in Patent Office: 1,433 Days
• Field of Search: 606/153, 606205-209, 606/219, 606/220, 606/157, 606/158, 606/144, 606/148, 606/149, 606/139, 227/175.1, 128/898, 600/104, 600/201, 600/203, 600/205, 600/206, 600/210, 600/217
• US Class Current: 606/153
• CPC Class Codes: A61B 1/2736 Gastroscopes
• 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 17/06109 Big needles, either gripped by hand or connectable to a handle
• 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 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0461 with features cooperating with special features on the suture, e.g. protrusions on the suture
• CPC Class Codes: A61B 2017/0462 One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• 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 2017/081 : Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2017/306 : holding by means of suction

Abstract

Endoscopic devices and methods used for fastening multiple tissue layers, such as, for example, an endoscopic fundoplication procedure, are disclosed. The device may include, for example, an elongated tubular member having a proximal end for extending outside of the body and a distal end for positioning proximate the multiple tissue layers, a grasper configured for positioning proximate the distal end of the tubular member and for grasping at least one of the multiple tissue layers, a device coupled to the distal end of the tubular member for folding the multiple tissue layers together, a tissue fastener configured to be inserted into the tissue layers to hold the tissue layers together, and a fastener head for inserting the tissue fastener into the tissue layers.

Claims

1. A system for fastening multiple tissue layers of a body, comprising:

an elongated tubular member having a proximal end for extending outside of the body and a distal end for positioning proximate the multiple tissue layers;

a grasper configured for positioning proximate the distal end of the tubular member and for grasping at least one of the multiple tissue layers;

a device coupled to the distal end of the tubular member for folding the multiple tissue layers together, the device comprising;

a main body; and

a folding arm pivotally connected to the main body,

wherein the folding arm is configured to pivotally move with respect to the main body and to receive the multiple tissue layers between the main body and the folding arm;

a tissue fastener configured to be inserted into the tissue layers to hold the tissue layers together; and

a fastener delivery system for deploying the tissue fastener into the tissue layers.

2. The system of claim 1, wherein the folding arm is configured to be substantially flush with an outer surface of the main body when the folding arm is in a closed position.

3. The system of claim 1, wherein the folding arm includes an opening configured to allow passage of the tissue fastener.

4. The system of claim 3, wherein the opening extends along substantially the entire length of the folding arm, and the opening has an open end on one end.

5. The system of claim 1, wherein the folding arm includes at least one friction-enhancing member on a surface facing the main body.

6. The system of claim 1, further comprising an actuation member configured to control operation of the device, the actuation member comprising:

a handle proximate the proximal end of the tubular member; and

at least one elongate member for coupling the handle to the device.

7. The system of claim 6, wherein the at least one elongate member extends from the handle, along a length of the main body, and along a portion of the folding arm, wherein axial movement of the at least one elongate member causes pivotal movement of the folding arm relative to the main body.

8. The system of claim 7, wherein the main body includes two paths formed along the length of the main body, wherein the at least one elongate member passes through the two paths and is freely slidable relative to the main body within the paths.

9. The system of claim 6, wherein the handle includes a driving mechanism for slidably moving the at least one elongate member.

10. The system of claim 9, wherein the handle includes a rotatable member associated with the driving mechanism, wherein rotational movement of the rotatable member causes axial movement of the elongate member.

11. The system of claim 1, wherein the tubular member is substantially flexible to traverse through a tortuous path within the body.

12. The system of claim 1, wherein the grasper is one selected from the group consisting of clamps, forceps, hooks, suction cups, and suction tubes.

13. The system of claim 1, wherein the tissue fastener comprises a first member, a second member, and a connecting member connecting between the first member and the second member.

14. The system of claim 13, wherein the connecting member is selected from a group consisting of a suture, a bar, a coil, and a spring.

15. A method of fastening multiple tissue layers together, comprising:

inserting an elongated tubular member into a body passage so that a distal end of the tubular member is proximate the tissue layers;

positioning a grasper proximate the distal end of the tubular member;

grasping at least one of the multiple tissue layers by the grasper;

folding the multiple tissue layers together by a distal body of the tubular member; and

inserting a tissue fastener into the tissue layers to hold the tissue layers together,

wherein the tubular member includes a distal body having a main body and a foldable arm rotatably coupled to the main body, and

wherein folding the multiple tissue layers includes rotating the foldable arm to an open position to receive the multiple tissue layers between the main body and the foldable arm.

16. The method of claim 15, further comprising inserting an endoscope into the body passage proximate the tissue layers.

17. The method of claim 15, wherein folding the multiple tissue layers includes extending the distal body distally before rotating the foldable arm.

18. The method of claim 15, wherein folding the multiple tissue layers further comprises rotating the foldable arm to a closed position to fold the multiple tissue layers.

19. The method of claim 15, further comprising inserting the grasper through a lumen of the tubular member proximate the tissue layers.

20. The method of claim 15, further comprising holding the at least one of the multiple tissue layers grasped by the grasper.

21. The method of claim 15, wherein the multiple tissue layers include an esophageal wall and a fundus wall, and the step of inserting an elongated tubular member includes inserting the tubular member transorally into a gastro-esophageal junction site through an esophagus.

24. The system of claim 20, further comprising a holding member disposed proximate the suction opening for holding the tissue layer grasped by the suction.

25. The system of claim 24, wherein the holding member includes a jaw assembly.

26. The system of claim 25, wherein the jaw assembly includes a pair of jaws attached to a flexible member such that the pair of jaws move toward each other when the flexible member is deformed for enabling the holding of the tissue layer grasped by the suction.

27. The system of claim 26, further comprising an actuation device configured to deform the flexible member.

22. A system for fastening multiple tissue layers of a body, comprising:

an elongated tubular member having a proximal end for extending outside of the body and a distal end for positioning proximate the multiple tissue layers;

a grasper configured for positioning proximate the distal end of the tubular member and for grasping at least one of the multiple tissue layers;

a device coupled to the distal end of the tubular member for folding the multiple tissue layers together;

a tissue fastener configured to be inserted into the tissue layers to hold the tissue layers together; and

a fastener delivery system for deploying the tissue fastener into the tissue layers,

wherein the grasper is configured to use suction to grasp the at least one of the multiple tissue layers.

23. The system of claim 22, wherein the grasper comprises:

a proximal member having a connection to a source of suction;

an elongated conduit having a proximal end extending to the proximal member and a distal end for extending proximate the distal end of the tubular member, the conduit having a lumen in fluid communication with the connection; and

a distal member connected to a distal end of the conduit and configured to grasp the at least one of the multiple tissue layers when the suction is applied.

28. The system of claim 23, wherein the distal member comprises an elongate head and a concave insert, the head and the insert being engaged with each other to form a space therebetween.

29. The system of claim 28, wherein the concave insert is translucent.

30. A system for fastening multiple tissue layers of a body, comprising:

an elongated tubular member having a proximal end for extending outside of the body and a distal end for positioning proximate the multiple tissue layers;

a grasper configured for positioning proximate the distal end of the tubular member and for grasping at least one of the multiple tissue layers;

a device coupled to the distal end of the tubular member for folding the multiple tissue layers together;

a tissue fastener configured to be inserted into the tissue layers to hold the tissue layers together;

a fastener delivery system for deploying the tissue fastener into the tissue layers; and

a removable protection device to cover at least a portion of the device during insertion of the device into the body.

31. The system of claim 30, wherein the removable protection device includes a protective sleeve and a handle having a length sufficient to extend through a lumen of the tubular member and outside of the body.

32. The system of claim 31, wherein the sleeve is configured to be pulled through the lumen of the tubular member by pulling the handle.

33. The system of claim 31, wherein at least a portion of the sleeve includes a mesh.

34. The system of claim 31, wherein the sleeve has an opening on its distal end portion.

35. The system of claim 30, wherein the protection device includes an inflatable balloon.

36. The system of claim 35, further comprising a tube in fluid communication with the balloon for supplying an inflation fluid from a fluid source.

37. The system of claim 35, wherein the balloon forms a substantially hollow cylindrical body with a tapered end.

38. The system of claim 37, wherein an opening formed by the hollow cylindrical body is configured to allow passage of an endoscope.

39. The system of claim 38, wherein, when the balloon is inflated, the balloon seals against the endoscope.

40. A system for fastening multiple tissue layers of a body, comprising:

an elongated tubular member having a proximal end for extending outside of the body and a distal end for positioning proximate the multiple tissue layers;

a grasper configured for positioning proximate the distal end of the tubular member and for grasping at least one of the multiple tissue layers;

a device coupled to the distal end of the tubular member for folding the multiple tissue layers together;

a tissue fastener configured to be inserted into the tissue layers to hold the tissue layers together; and

a fastener delivery system for deploying the tissue fastener into the tissue layers, the fastener delivery system comprising;

an elongated tube having a proximal end for extending outside of the body and a distal end for positioning proximate the multiple tissue layers;

a driver head coupled to the distal end of the tube, the driver head having a slot configured to hold the tissue fastener; and

a needle configured to extend from the proximal end of the tube to the slot in the driver head via a lumen of the tube.

41. The system of claim 40, wherein the driver head includes a groove for guiding the needle to the slot.

42. The system of claim 40, wherein the tissue fastener includes a proximal member and a distal member connected to the proximal member via a connecting member.

43. The system of claim 42, wherein the proximal member of the fastener is configured to be placed in the slot of the driver head for deployment.

44. The system of claim 42, further comprising a cutting member configured to cut excess connecting member of the tissue fastener after the fastener is deployed.

45. The system of claim 42, wherein the driver head includes a second slot for receiving the cutting member.

46. The system of claim 40, wherein the needle includes a needle driver coupled to the proximal end of the needle.

47. The system of claim 46, further comprising a drive handle coupled to the proximal end of the tube, wherein the drive handle is configured to control the operation of the needle.

48. The system of claim 47, wherein the needle driver and the driver handle are configured to limit at least one of axial and rotational movements of the needle.

49. The system of claim 48, further comprising a pusher configured to be slidably inserted into a conduit of the needle.

50. The system of claim 49, wherein the pusher includes a grasping member configured to grasp at least a portion of the tissue fastener.

51. A system for fastening multiple tissue layers of a body, comprising:

an elongated tubular member having a proximal end for extending outside of the body and a distal end for positioning proximate the multiple tissue layers;

a grasper configured for positioning proximate the distal end of the tubular member and for grasping at least one of the multiple tissue layers;

a device coupled to the distal end of the tubular member for folding the multiple tissue layers together;

a tissue fastener configured to be inserted into the tissue layers to hold the tissue layers together; and

a fastener delivery system for deploying the tissue fastener into the tissue layers,

wherein the tissue fastener comprises a first member, a second member, and a connecting member connecting between the first member and the second member, and

wherein one of the first and second members has a greater footprint than the other of the first and second members.

52. A system for fastening multiple tissue layers of a body, comprising:

an elongated tubular member having a proximal end for extending outside of the body and a distal end for positioning proximate the multiple tissue layers;

a grasper configured for positioning proximate the distal end of the tubular member and for grasping at least one of the multiple tissue layers;

a device coupled to the distal end of the tubular member for folding the multiple tissue layers together;

a tissue fastener configured to be inserted into the tissue layers to hold the tissue layers together; and

a fastener delivery system for deploying the tissue fastener into the tissue layers,

wherein the tissue fastener comprises a first member, a second member, and a connecting member connecting between the first member and the second member, and

wherein at least one of the first and second members is dome-shaped.

53. A system for fastening multiple tissue layers of a body, comprising:

an elongated tubular member having a proximal end for extending outside of the body and a distal end for positioning proximate the multiple tissue layers;

a grasper configured for positioning proximate the distal end of the tubular member and for grasping at least one of the multiple tissue layers;

a device coupled to the distal end of the tubular member for folding the multiple tissue layers together;

a tissue fastener configured to be inserted into the tissue layers to hold the tissue layers together; and

a fastener delivery system for deploying the tissue fastener into the tissue layers,

wherein the tissue fastener comprises a first member, a second member, and a connecting member connecting between the first member and the second member, and

wherein the first member is fixedly attached to the connecting member and the second member is movable along the connecting member.

54. The system of claim 53, further comprising a tension-adjusting member to adjust the tension of the connecting member between the first and second members.

55. The system of claim 54, wherein the second member includes an opening through which the connecting member passes, the tension-adjusting member including a friction member attached to the second member and configured to selectively allow movement of the connecting member relative to the second member.

56. The system of claim 55, wherein the tension-adjusting member is configured to allow movement of the connecting member in only one direction relative to the second member.

57. The system of claim 53, wherein:

the second member includes a first opening and a second opening with a slot communicating between the first and second openings;

the connecting member includes a plurality of stopping members;

the first opening is larger than the cross-sectional area of the stopping members so as to allow passage of the stopping members through the first opening;

the second opening is smaller than the cross-sectional area of the stopping members so as not to allow passage of the stopping members through the second opening; and

the slot is large enough to allow passage of the connecting member other than the stopping members.

58. A method of fastening multiple tissue layers together, comprising:

inserting an elongated tubular member into a body passage so that a distal end of the tubular member is proximate the tissue layers;

positioning a grasper proximate the distal end of the tubular member;

grasping at least one of the multiple tissue layers by the grasper;

folding the multiple tissue layers together by a distal body of the tubular member;

inserting a tissue fastener into the tissue layers to hold the tissue layers together; and

covering at least the distal end of the tubular member with a protective sleeve.

59. The method of claim 58, further comprising removing the protective sleeve after inserting the tubular member into the body passage.

60. The method of claim 59, wherein removing the protective sleeve includes retracting the protective sleeve proximally through a lumen of the tubular member.

61. A method of fastening multiple tissue layers together, comprising:

inserting an elongated tubular member into a body passage so that a distal end of the tubular member is proximate the tissue layers;

positioning a grasper proximate the distal end of the tubular member;

grasping at least one of the multiple tissue layers by the grasper;

folding the multiple tissue layers together by a distal body of the tubular member; and

inserting a tissue fastener into the tissue layers to hold the tissue layers together,

wherein the grasping step is performed by a suction grasper that uses a suction mechanism to grasp the at least one of the multiple tissue layers.

62. A method of fastening multiple tissue layers together, comprising:

inserting an elongated tubular member into a body passage so that a distal end of the tubular member is proximate the tissue layers;

positioning a grasper proximate the distal end of the tubular member;

grasping at least one of the multiple tissue layers by the grasper;

folding the multiple tissue layers together by a distal body of the tubular member;

inserting a tissue fastener into the tissue layers to hold the tissue layers together, and

pushing the grasped tissue layer distally before folding the multiple tissue layers.

63. A method of fastening multiple tissue layers together, comprising:

inserting an elongated tubular member into a body passage so that a distal end of the tubular member is proximate the tissue layers;

positioning a grasper proximate the distal end of the tubular member;

grasping at least one of the multiple tissue layers by the grasper;

folding the multiple tissue layers together by a distal body of the tubular member;

inserting a tissue fastener into the tissue layers to hold the tissue layers together; and

delivering the tissue fastener through a lumen of the tubular member.

64. The method of claim 63, wherein:

the tissue fastener includes a first member, a second member, and a connecting member connecting the first and second members; and

wherein a needle holds the first member and a fastener receiving member receives the second member.

65. The method of claim 64, wherein the needle has a sharp distal edge and a lumen for holding the first member.

66. The method of claim 65, wherein the step of delivering the tissue fastener further comprises holding the first member with a pusher, the pusher configured to reciprocally move in and out of the lumen of the needle.

67. The method of claim 65, further comprising passing the needle holding the first member through the folded multiple tissue layers and releasing the first member so as to anchor the first member against a first surface of the multiple tissue layers.

68. The method of claim 67, further comprising contacting the second member against the multiple tissue layers on a second surface opposite to the first surface.

69. The method of claim 68, further comprising adjusting the tension of the fastener by moving at least one of the first and second members relative to each other along the connecting member.