Endoscopic tissue apposition device with multiple suction ports

• US 20030208209A1
• Filed: 03/24/2003
• Published: 11/06/2003
• Est. Priority Date: 03/03/2000
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton Dickinson & Co)
• Inventors: Weiser, Michael F., Gambale, Richard A., Lukin, Peter J., Page, Edward C.
• Granted Patent: US 7,399,304 B2
• Time in Patent Office: Days
• US Class Current: 606/144
• 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 17/0401 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 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• 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 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/061 hollow or tubular
• 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
• CPC Class Codes: A61B 2018/00291 using suction

Abstract

An improved endoscopic tissue apposition device (50) having multiple suction ports (86) permits multiple folds of tissue to be captured in the suction ports (86) with a single positioning of the device (50) and attached together by a tissue securement mechanism such as a suture (14), staple or other form of tissue bonding. The improvement reduces the number of intubations required during an endoscopic procedure to suture tissue or join areas of tissue together. The suction ports (86) may be arranged in a variety of configurations on the apposition device (50) to best suit the desired resulting tissue orientation. The tissue apposition device (50) may also incorporate tissue abrasion means (852) to activate the healing process on surfaces of tissue areas that are to be joined by operation of the device to promote a more secure attachment by permanent tissue bonding.

Claims

1. An endoscopic tissue apposition device comprising:

a capsule body having a plurality of suction ports and at least one vacuum chamber in communication with a suction port and having an air passage, the chamber configured to capture a plurality of tissue sections through the plurality of suction ports when vacuum is applied in the vacuum chamber through the air passage;

at least one needle longitudinally advanceable through the capsule body and configured to deliver a tissue securement device to secure the captured tissue.

2. An endoscopic tissue apposition device as defined in claim 1 wherein the capsule body comprises an injection molded polymer.

3. An endoscopic tissue apposition device as defined in claim 1 further comprising at least one hinge incorporated in the capsule body permitting longitudinal flexure of the body in at least one direction to permit passage of the capsule body through a natural body lumen.

4. An endoscopic tissue apposition device as defined in claim 3 further comprising:

selectively engageable locking rods operable to prevent the capsule body from flexing about the hinge.

5. An endoscopic tissue apposition device as defined in claim 1 further wherein:

the tissue securement mechanism comprises a suture tag and the capsule is configured to have an ejection ramp oriented to guide the suture tag up and away from the capsule as it is ejected from the needle.

6. An endoscopic tissue apposition device as defined in claim 1 where in the tissue apposition device further comprises:

a magazine configured to hold a plurality of sutures in readiness for sequential and automatic loading into the needle.

7. An endoscopic tissue apposition device as defined in claim 1 further comprising independent vacuum chambers each in dedicated communication with a suction port and configured to be independently activated to capture tissue sequentially into the suction ports.

8. An endoscopic tissue apposition device as defined in claim 1 further comprising:

a circumferential ridge surrounding and protruding from the suction port to engage and form a seal with surrounding tissue during tissue suction.

9. An endoscopic tissue apposition device as defined in claim 1 further comprising:

a capture recess formed in surfaces that define the vacuum chambers to help mechanically retain tissue captured into the chamber under vacuum.

48. An endoscopic tissue apposition device as defined in claim 1 wherein the suction ports are arranged longitudinally in-line and the needle advances along a pathway that traverses both suction ports to penetrate captured tissue portions.

49. An endoscopic tissue apposition device as defined in claim 1 wherein two suction ports are arranged side by side and the needle is forked and arranged in the capsule such that each fork of the needle traverses a suction port during longitudinal advancement to penetrate captured tissue portions.

50. An endoscopic tissue apposition device as defined in claim 49 wherein the tissue securement device comprises sutures joined to suture tags that are releasably carried at the distal ends of the forks and are configured to be ejected from the needle after tissue penetration by the needle.

51. An endoscopic tissue apposition device as defined in claim 50 wherein the suture tags have sharp distal tips that serve to pierce the tissue during needle advancement.

52. An endoscopic tissue apposition device as defined in claim 50 wherein the tissue securement device additionally comprises a tag lock releasably securable to the capsule and comprising a lock block having at least one tag receptacle for receiving and capturing a suture tag that is being advanced through tissue at the distal end of a needle.

53. An endoscopic tissue apposition device as defined in claim 52 wherein the lock block of a tag lock aligned with one fork of the needle is joined to a tag carried by the opposing fork of the needle by a suture.

54. An endoscopic tissue apposition device as defined in claim 52 wherein the lock block further comprises a passage sized to permit suture material to slide through.

55. An endoscopic tissue apposition device as defined in claim 1 wherein two suction ports are arranged side by side and a plurality of independently advanceable needles are provided and arranged so that each needle may be advanced to traverse a single dedicated suction port to penetrate captured tissue portions.

56. An endoscopic tissue apposition device as defined in claim 55 wherein the capsule is configured to provide a needle pathway having a diverter that causes the needles to divert from a path along the longitudinal axis of the capsule to a path away from the longitudinal axis but directed to the suction port to which the given needle is dedicated.

57. An endoscopic tissue apposition device as defined in claim 55 wherein each suction port is in communication with a dedicated vacuum chamber.

58. An endoscopic tissue apposition device as defined in claim 56 wherein four suction supports are provided arranged in two sets of two on the top and bottom of the capsule.

59. An endoscopic tissue apposition device as defined in claim 55 wherein the tissue securement device comprises sutures joined to suture tags that are releasably carried at the distal ends of the needles and are configured to be ejected from the needles after tissue penetration by the needles.

60. An endoscopic tissue apposition device as defined in claim 55 wherein the suture tags have sharp distal tips that serve to pierce the tissue during needle advancement.

61. An endoscopic tissue apposition device as defined in claim 55 wherein the tissue securement device additionally comprises a tag lock releasably securable to the capsule and comprising a lock block having at least one tag receptacle for receiving and capturing a suture tag that is being advanced through tissue at the distal end of a needle.

62. An endoscopic tissue apposition device as defined in claim 61 wherein the lock block of a tag lock aligned with one fork of the needle is joined to a tag carried by the needle dedicated to the other suction port.

63. An endoscopic tissue apposition device as defined in claim 61 wherein the lock block further comprises a passage sized to permit suture material to slide through.

64. An endoscopic tissue apposition device as defined in claim 1 wherein two suction ports are arranged on the capsule to be angularly and longitudinally offset from each other and a plurality of independently advanceable needles are provided and arranged so that each needle may be advanced to traverse a single dedicated suction port to penetrate captured tissue portions.

10. An endoscopic tissue apposition device comprising:

a suturing capsule body having at least one suction port and at least one vacuum chamber in communication with a suction port to receive tissue and having an air passage, the chamber configured to capture a section of tissue within the chamber when vacuum is applied through the air passage;

at least one needle longitudinally advanceablele through the capsule body and configured to carry suture material through the captured tissue;

means to eject the suture from the needle after it has passed through the captured tissue;

a magazine configured to hold a plurality of sutures in readiness for sequential and automatic loading into the needle with each full length stroke of the needle through the suture body.

11. An endoscopic tissue apposition device comprising:

a sewing capsule body having at least one suction port and at least vacuum chamber to receive tissue having a plurality of surfaces and an air passage, the vaccum chamber configured to capture tissue within the chamber when vacuum is applied through the air passage;

a needle longitudinally advanceable through the capsule body and configured to carry suture material through the captured tissue;

a suture ejection mechanism operably associated with the needle to eject the suture from the needle after it has passed through the captured tissue;

a hinge incorporated in the capsule body permitting longitudinal flexure of the body in at least one direction to permit passage of the body through a natural body lumen.

12. A method of fabricating an endoscopic tissue apposition device comprising:

injection molding a polymer material into a configuration of a sewing capsule body having at least one suction port in communication with at least one vacuum chamber defined by at least one surface and having an air passage for communication with a source of vacuum, each port configured to receive a section of tissue into the chamber when vacuum is applied through the air passage

the capsule also configured to guide at least one needle in longitudinal movement along a path that traverses a suction port.

13. A method of joining internal body tissue endoscopically comprising:

providing an endoscopic tissue apposition device having multiple suction ports attached to a distal end of an endoscope;

navigating the distal end of the endoscope and tissue apposition device to the treatment site;

applying vacuum to the tissue apposition device to capture at least two portions of tissue through the suction ports;

advancing a tissue securement mechanism to secure the tissue portions together.

14. A method of joining internal body tissue endoscopically as defined in claim 13 where in the step of advancing a tissue securement mechanism further comprises:

passing a needle carrying a suture through at least one section of tissue to a through side of the tissue;

ejecting one end of the suture from the needle on the through side of the tissue;

withdrawing the needle from the tissue;

discontinuing vacuum to release the tissue from the apposition device;

tightening and securing the suture in the tissue.

15. A method of joining internal body tissue endoscopically as defined in claim 14 further comprising:

providing in the tissue apposition device a magazine capable of holding multiple sutures that is operatively associated with the needle to reload the needle with a suture after each complete stroke of the needle through the tissue apposition device;

advancing the needle to deliver a suture through the portions of tissue;

withdrawing the needle from the tissue;

releasing the tissue from the tissue apposition device;

relocating the tissue apposition device to a new area of tissue and capturing that tissue in the sewing device by reapplying a vacuum;

reloading the needle with a suture from the magazine;

repeating the method of claim 13 to place a plurality of sutures in a plurality of tissue locations.

16. A method as defined in claim 14 wherein one end of the suture remains anchored against the through side of the tissue and the free end of the suture is secured against the tissue in a secondary step.

68. A method of joining internal body tissue endoscopically as defined in claim 13 wherein the step of advancing a tissue securement mechanism further comprises:

passing a forked needle carrying a sutures at its forks through a plurality of sections of tissue to a through side of the tissues;

ejecting one end of each suture from the forks of the needle on the through side of the tissue;

withdrawing the needle from the tissue;

discontinuing vacuum to release the tissue from the apposition device;

tightening and securing the suture in the tissue.

69. A method of joining internal body tissue endoscopically as defined in claim 13 where in the step of advancing a tissue securement mechanism further comprises:

independently advancing a plurality of needles each carrying a sutures at through a plurality of sections of tissue to a through side of the tissues;

ejecting one end of each suture from the forks of the needle on the through side of the tissue;

withdrawing the needle from the tissue;

discontinuing vacuum to release the tissue from the apposition device;

tightening and securing the suture in the tissue.

70. A method of joining internal body tissue endoscopically as defined in claim 13 wherein four tissue sections are captured through four suction ports and secured together with one intubation of the endoscope.

17. An endoscopic tissue apposition device comprising a capsule body having a plurality of suction ports, each having a vacuum chamber to receive tissue having an air passage, each chamber configured to capture a section tissue within the chamber when vacuum is applied through the air passage;

a tissue securement device;

and a tissue securement device advancement mechanism configured to place the tissue securement device through the portions captured tissue and release from the securement device after advancement.

18. An endoscopic tissue apposition device comprising:

a capsule body having a plurality of suction ports to receive tissue;

at least one vacuum chamber in communication with at least two suction ports;

a tissue securement device; and

a tissue securement device advancement mechanism configured to place a tissue securement device through a section of captured tissue and release from the securement device after advancement.

19. An endoscopic tissue apposition device comprising:

a tissue capture mechanism;

a tissue securement device for securing captured tissue; and

tissue abrasion means.

20. An endoscopic tissue apposition device as defined in claim 19 wherein the tissue abrasion mechanism comprises an electrically activated element.

21. An endoscopic tissue apposition device as defined in claim 19 wherein the tissue abrasion mechanism further comprises a transmitter of radio frequency energy.

22. An endoscopic tissue apposition device as defined in claim 19 wherein the tissue abrasion mechanism further comprises a transmitter of laser energy to abrade tissue.

23. An endoscopic tissue apposition device as defined in claim 19 wherein the tissue abrasion mechanism further comprises a transmitter of ultrasonic energy to abrade tissue.

24. An endoscopic tissue apposition device as defined in claim 19 wherein the tissue abrasion mechanism comprises means for releasing a chemically abrasive substance.

25. A tissue apposition device as defined in claim 19 wherein the tissue abrasion mechanism includes means for releasing a biomedical substance to cause tissue abrasion.

26. An endoscopic tissue apposition device as defined in claim 19 wherein the tissue abrasion mechanism abrades tissue mechanically by causing frictional contact with the tissue.

27. An endoscopic tissue apposition device as defined in claim 26 wherein mechanical abrasion is achieved by delivering through the abrasion mechanism a biocompatible mechanically abrasive substance to the tissue.

28. An endoscopic tissue apposition device as defined in claim 26 wherein the tissue abrasion mechanism further comprises a mechanical element configured to frictionally engage tissue.

29. An endoscopic tissue apposition device as defined in claim 19 wherein the capture mechanism comprises at least one vacuum chamber adapted to receive a double fold of tissue.

30. An endoscopic tissue apposition device as defined in claim 19 wherein the tissue securement device comprises a staple.

31. An endoscopic tissue apposition device as defined in claim 19 wherein the tissue securement mechanism comprises a suture.

44. A method of adjoining adjacent areas of internal tissue as defined in claim 25 further comprising:

the step of increasing the amount of captured tissue after the abrasion step and prior to applying the tissue securement device.

32. An endoscopic suturing device comprising:

a sewing capsule body having a plurality of suction ports, an opening to receive tissue and at least one vacuum chamber in communication with the suction ports and in communication with a source of vacuum, each chamber configured to hold a double layer of tissue within the chamber when vacuum is applied through the suction ports;

a needle longitudinally slidable through the capsule body and configured to carry suture materials through the captured tissue;

means to eject the suture from the needle after it has passed through the captured tissue;

at least one tissue abrasion mechanism on the sewing capsule body adjacent to the opening of at least suction port.

33. An endoscopic suturing device as defined in claim 32 wherein the abrasion mechanism is positioned centrally between adjacent suction port on the capsule body.

34. An endoscopic suturing device as defined in claim 32 wherein the tissue abrasion mechanism comprises an electrically activated element.

35. An endoscopic tissue device as defined in claim 32 wherein the tissue abrasion mechanism comprises a transmitter of radio frequency energy.

36. An endoscopic suturing device as defined in claim 32 wherein the tissue abrasion mechanism comprises a transmitter of laser energy to abrade tissue.

37. An endoscopic suturing device as defined in claim 32 wherein the tissue abrasion mechanism comprises a transmitter of ultrasonic energy to abrade tissue.

38. An endoscopic suturing device as defined in claim 32 wherein the tissue abrasion mechanism comprises means for releasing a chemically abrasive substance.

39. A tissue suturing device as defined in claim 32 wherein the tissue abrasion mechanism includes means for releasing a biomedical substance to cause tissue abrasion.

40. An endoscopic tissue apposition device as defined in claim 32 wherein the tissue abrasion mechanism abrades tissue mechanically by causing frictional contact with the tissue.

41. An endoscopic tissue apposition device as defined in claim 40 wherein mechanical abrasion is achieved by delivering through the abrasion mechanism a biocompatible mechanically abrasive substance to the tissue.

42. An endoscopic tissue apposition device as defined in claim 40 wherein the tissue abrasion mechanism further comprises a mechanical element configured to frictionally engage tissue.

43. A method of adjoining adjacent areas of internal tissue comprising:

providing an endoscopic tissue apposition device configured to temporarily capture at least one area of internal tissue, abrade an area of the tissue and apply a tissue securement device to hold captured areas of tissue in apposition, at least temporarily;

capturing at least one area of tissue;

abrading an area of the tissue;

applying a securement device through the captured tissue;

releasing the tissue;

repositioning the apposition device to an adjacent area of tissue;

capturing a portion of the adjacent tissue;

abrading an area of the adjacent tissue;

applying a tissue securement device through the tissue;

releasing the tissue and withdrawing the apposition device from the patient;

joining the tissue securement devices together to bring the subject tissue areas into contact, at least in the areas that have been abraded.

45. A method of adjoining adjacent areas of internal tissue comprising:

providing a tissue apposition device configured to capture a plurality of tissue areas in a single positioning, having a tissue abrasion mechanism and configured to deliver at least one tissue securement device through the areas of captured tissue;

capturing a plurality of tissue areas;

abrading an area of tissue at least between the areas of captured tissue;

applying a tissue securement device through the captured areas of tissue and releasing the captured areas of tissue.

46. A method of adjoining adjacent areas of internal tissue as defined in claim 45 further comprising:

the step of increasing the amount of captured tissue after the step of abrading the tissue and prior to the step of applying a tissue securement device through the areas of tissue.

47. An endoscopic tissue apposition device comprising:

a capsule body having a plurality of suction ports and at least one vacuum chamber in communication with a suction port and having an air passage, the chamber configured to capture a plurality of tissue sections through the plurality of suction ports when vacuum is applied in the vacuum chamber;

at least one needle longitudinally advanceable through the capsule body and configured to deliver a suture through the captured tissue to a though side of the tissue;

means to maintain one end of the suture on the through side of the tissue after the needle is withdrawn form the captured tissue.

65. An endoscopic tissue apposition device comprising:

a capsule body having a plurality of suction ports and at least one vacuum chamber in communication with a suction port and the chamber having an air passage, the chamber configured to capture a plurality of tissue sections through the plurality of suction ports when vacuum is applied in the vacuum chamber through the air passage;

at least one tissue implant longitudinally advanceable through the capsule body and configured to penetrate tissue during advancement and configured to be released from the capsule to hold the plurality of tissue portions together after advancement completed.

66. An endoscopic tissue apposition device as defined in claim 65 wherein the implant comprises a helical coil.

67. An endoscopic tissue apposition device as defined in claim 66 wherein the coil is coated with a bulking agent.