Method and device for use in tissue approximation and fixation

• US 20040006351A1
• Filed: 07/02/2002
• Published: 01/08/2004
• Est. Priority Date: 07/02/2002
• Status: Active Grant

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Satiety, Inc.
• Inventors: Sutton, Douglas S., Gerbi, Craig, Mata, Gilbert Jr., Weller, Gary, Gannoe, Jamy, Scott, J. Stephen
• Granted Patent: US 6,773,440 B2
• Time in Patent Office: Days
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• 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 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 2017/00561 creating a vacuum
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2017/2929 with a head rotatable about the longitudinal axis of the shaft
• CPC Class Codes: A61B 2017/2944 Translation of jaw members
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61F 5/0086 using clamps, folding means or the like

Abstract

Methods and devices for use in tissue approximation and fixation are described herein. The present invention provides, in part, methods and devices for acquiring tissue folds from the anterior and posterior portions of a hollow body organ, e.g., a stomach, positioning the tissue folds for affixing within a fixation zone of the stomach, preferably to create a pouch or partition below the esophagus, and fastening the tissue folds such that a tissue bridge forms excluding the pouch from the greater stomach cavity. The present invention further provides devices for performing a transoral, endoscopic hollow organ division, including a tissue acquisition device capable of acquiring the desired tissue, a tensioning device for positioning the acquired tissue, and a fastening element to secure the outer layers of the acquired tissue such that the desired healing response is achieved.

Claims

1. A method of partitioning a hollow body organ from within, said method comprising:

positioning a tissue acquisition device into the hollow body organ, said tissue acquisition device having a proximal end and a distal end and a lumen therebetween with a tissue acquiring mechanism at the distal end thereof;

acquiring a first tissue region and a second tissue region within at least one opening defined in said tissue acquiring mechanism such that said acquired tissue is in juxtaposition with each other;

advancing a tissue fastening assembly to the juxtaposed tissue, said tissue fastening assembly device having a clamping distal portion; and

actuating the clamping distal portion to engage said tissue folds with a fastening element such that said tissue folds remain affixed to one another.

2. The method of claim 1 wherein positioning the tissue acquisition device comprises transorally advancing the tissue acquisition device into the hollow body organ.

3. The method of claim 1 wherein positioning the tissue acquisition device comprises percutaneously advancing the tissue acquisition device into the hollow body organ.

4. The method of claim 1 wherein acquiring the first tissue region and the second tissue region comprises drawing the tissue within the opening via a vacuum force.

5. The method of claim 1 further comprising translationally moving the first tissue region and the second tissue region relative to each other from a first configuration to a second configuration in which the tissue regions are positioned into apposition with each other prior to actuating the clamping distal portion.

6. The method of claim 5 further comprising tensioning the juxtaposed tissue while translationally moving the first tissue region and the second tissue region.

7. The method of claim 1 wherein the tissue acquiring mechanism comprises at least one fenestration defined along the tissue acquiring mechanism.

8. The method of claim 1 wherein advancing the tissue fastening assembly comprises advancing a stapler to the juxtaposed tissue.

9. The method of claim 1 wherein actuating the clamping distal portion comprises engaging the tissue folds to create a tissue bridge such that a pouch is created within the hollow body organ.

10. The method of claim 9 wherein the tissue bridge is angled relative to an interior wall of the hollow body organ such that a narrow channel is maintained in communication between the pouch and the hollow body organ.

11. The method of claim 9 further comprising engaging tissue folds in multiple areas within the hollow body organ.

12. The method of claim 1 wherein the first tissue region comprises a posterior wall of the hollow body organ and the second tissue region comprises the anterior wall of the of hollow body organ.

13. The method of claim 1 wherein the fastening element is selected from the group consisting of staples, clamps, and rivets.

14. The method of claim 10 wherein the fastening element is bioabsorbable or biofragmentable.

15. A method of partitioning a hollow body organ from within, said method comprising:

positioning a tissue acquisition device into the hollow body organ, said tissue acquisition device having a proximal end and a distal end and a lumen therebetween with a tissue acquiring mechanism at the distal end thereof;

acquiring a first tissue region and a second tissue region within at least one opening defined in said tissue acquiring mechanism such that said acquired tissue is in juxtaposition with each other;

translationally moving the first tissue region and the second tissue region relative to each other from a first configuration to a second configuration in which the tissue regions are positioned into apposition with each other;

advancing a tissue fastening assembly to the juxtaposed tissue, said tissue fastening assembly device having a clamping distal portion; and

actuating the clamping distal portion to engage said tissue folds with a fastening element such that said tissue folds remain affixed to one another.

16. The method of claim 15 wherein positioning the tissue acquisition device comprises transorally advancing the tissue acquisition device into the hollow body organ.

17. The method of claim 15 wherein positioning the tissue acquisition device comprises percutaneously advancing the tissue acquisition device into the hollow body organ.

18. The method of claim 15 wherein acquiring the first tissue region and the second tissue region comprises drawing the tissue within the opening via a vacuum force.

19. The method of claim 15 further comprising tensioning the juxtaposed tissue while translationally moving the first tissue region and the second tissue region.

20. A method of partitioning a hollow body organ from within, said method comprising:

positioning a tissue acquisition device into the hollow body organ, said tissue acquisition device having a proximal end and a distal end and a lumen therebetween with a tissue acquiring mechanism at the distal end thereof;

acquiring a first tissue region within at least one opening defined in said tissue acquiring mechanism;

advancing a tissue fastening assembly to the first tissue region, said tissue fastening assembly device having a clamping distal portion; and

actuating the clamping distal portion to engage said first tissue region with a fastening element such that said tissue folds remain affixed to one another.

21. The method of claim 20 further comprising acquiring a second tissue region within the at least one opening such that the second tissue region is in juxtaposition with the first tissue region prior to actuating the clamping distal portion.

22. The method of claim 21 further comprising tensioning the juxtaposed tissue while translationally moving the first tissue region and the second tissue region.

23. The method of claim 20 further comprising advancing a post distally within the tissue acquisition device to secure the first tissue region prior to actuating the clamping distal portion.

24. The method of claim 20 wherein positioning the tissue acquisition device comprises transorally advancing the tissue acquisition device into the hollow body organ.

25. The method of claim 20 wherein positioning the tissue acquisition device comprises percutaneously advancing the tissue acquisition device into the hollow body organ.

26. The method of claim 20 wherein acquiring the first tissue region comprises drawing the tissue within the opening via a vacuum force.

27. A tissue acquisition device, comprising:

an elongate main body having a proximal end, a distal end, and a length therebetween;

a first jaw member and a second jaw member each pivotally connected to the distal end of the main body,

wherein the first and the second jaw members are adapted to move from a first configuration to a second expanded configuration in which the jaw members are translationally positioned into apposition with each other, and

wherein the first and the second jaw members each define an opening for acquiring tissue therewithin, each opening being in fluid communication with at least one lumen defined in the main body.

28. The device of claim 27 wherein the main body defines additional lumens within the length.

29. The device of claim 27 further comprising at least one wire disposed within the main body for reinforcing the main body.

30. The device of claim 27 further comprising at least one pull wire disposed within the main body and attached along the length for selectively articulating the device.

31. The device of claim 27 further comprising at least one push rod disposed within the main body and attached along the length for selectively articulating the device.

32. The device of claim 27 further comprising a handle attached to the proximal end of the main body, the handle defining a main port therethrough which is in communication with the at least one lumen defined in the main body.

33. The device of claim 32 wherein the handle further comprises a lever for actuating the first and the second jaw member in a scissoring motion.

34. The device of claim 27 wherein the first and the second jaw members are connected to the main body via first and second hinging members, respectively.

35. The device of claim 34 wherein each hinging member comprises two crescent-shaped cutaways spaced longitudinally along the length of the main body at 180°

from one another.

36. The device of claim 27 wherein each opening on the first and the second jaw members are each defined at 180°

from one another.

37. The device of claim 27 wherein each opening has a length of about 1 in. longitudinally along each jaw member.

38. The device of claim 27 wherein each opening extends about 0-5 cm. into each jaw member.

39. The device of claim 27 further comprising at least one guide rod affixed to at least the first or the second jaw member, wherein the guide rod is adapted to tension the tissue when acquired within the opening.

40. The device of claim 39 wherein the guide rod comprises a rigid bar member affixed to the first and the second jaw member.

41. The device of claim 39 wherein the guide rod is curved to extend longitudinally adjacent to the first or the second jaw member.

42. The device of claim 27 further comprising a mechanical post adapted to be inserted down the lumen of the main body for securing the tissue.

43. The device of claim 27 further comprising a fastening assembly having a handle, a delivery body, and a clamping portion with clamping jaws attached to a distal end of the delivery body, the fastening assembly being adapted to be inserted through the main body.

44. The device of claim 43 further comprising at least one fastening element releasably disposed within the clamping jaws.

45. The device of claim 44 wherein the fastening element comprises a staple.

46. The device of claim 44 wherein the fastening element comprises a rivet and a receiving rivet portion for attachably receiving the rivet.

47. The device of claim 44 wherein the fastening element comprises an implantable clamp having a penetrating clamp portion for interfacing with a receiving clamp portion.

48. The device of claim 47 wherein the penetrating clamp portion comprises a patterned or textured tissue engagement surface.

49. The device of claim 47 wherein the receiving clamp portion comprises a patterned or textured tissue engagement surface.

50. The device of claim 47 wherein the implantable clamp has a curved configuration.

51. The device of claim 47 wherein the implantable clamp further comprises a hinge pivotally connecting the penetrating clamp portion to the receiving clamp portion.

52. The device of claim 44 wherein the fastening element is comprised of a material adapted to assist in tissue ingrowth and healing.

53. The device of claim 52 wherein the material is selected from the group consisting of meshes, grafts, microporous membranes, and biomaterials, collagen, and porcine biointestinal submucosa.

54. The device of claim 27 wherein the opening in the first and the second jaw members comprise a plurality of fenestrations defined along each of the jaw members.

55. The device of claim 27 wherein the opening in the first and the second jaw members comprise at least one fenestration.

56. An implantable clamp for affixing a region of tissue within a hollow body organ, comprising:

a penetrating clamp portion having a first tissue engagement surface which is patterned or textured; and

a receiving clamp portion having a second tissue engagement surface which is patterned or textured and is in apposition to the first tissue engagement surface;

wherein the penetrating clamp portion has at least one post for piercing through the region of tissue and engaging with the receiving clamp portion.

57. The device of claim 56 wherein the implantable clamp has a curved configuration.

58. The device of claim 56 wherein the implantable clamp further comprises a hinge pivotally connecting the penetrating clamp portion to the receiving clamp portion.