Endoscopic tissue apposition device with multiple suction ports

• US 7,399,304 B2
• Filed: 03/02/2001
• Issued: 07/15/2008
• Est. Priority Date: 03/03/2000
• Status: Expired due to Term

• 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.
• Primary Examiner(s): Woo; Julian W.
• Application Number:
  US10/220,379
• Publication Number:
  US 20030208209A1
• Time in Patent Office: 2,692 Days
• Field of Search: 606/139, 606/144, 606148-150, 606/153, 606/159, 606/213, 606/215, 606/216, 606/219, 606/221, 606/142, 606/32, 606/41, 606/44, 606/27, 606 50- 52, 606/75, 112/169, 227/175.1, 227/67, 227/68
• 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 17/0401 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 for applying suture clamps, clips or locks A61B2017/0488
• 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 J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• 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
• 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 by drawing the 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; and

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

2. 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 advanceable 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.

3. 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, and 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;

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 through the tissue to secure the tissue portions together, wherein the step of advancing a tissue securement mechanism 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; and

tightening and securing the suture in the tissue

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; and

repeating the aforementioned steps to place a plurality of sutures in a plurality of tissue locations.

4. 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 one suction port, wherein the tissue abrasion mechanism comprises an electrically activated element.

5. An endoscopic suturing device as defined in claim 4 wherein the abrasion mechanism is positioned centrally between adjacent suction port on the capsule body.

6. 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 one suction port, wherein the tissue abrasion mechanism comprises a transmitter of radio frequency energy.

7. 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 one suction port, wherein the tissue abrasion mechanism comprises a transmitter of laser energy to abrade tissue.

8. 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 one suction port, wherein the tissue abrasion mechanism comprises a transmitter of ultrasonic energy to abrade tissue.

9. 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 one suction port, wherein the tissue abrasion mechanism comprises means for releasing a chemically abrasive substance.

10. 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 one suction port, wherein the tissue abrasion mechanism includes means for releasing a biomedical substance to cause tissue abrasion.

11. 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;

increasing the amount of captured tissue after abrading the area of the tissue and prior to applying the tissue securement device;

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.

12. 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;

increasing the amount of captured tissue after abrading the area of tissue and prior to applying the tissue securement device.

13. 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 by drawing the tissue sections through the plurality of suction ports when vacuum is applied in the vacuum chamber through the air passage; and

at least one needle advanceable in a longitudinal direction through the capsule body and configured to deliver a tissue securement device to secure the captured tissue;

wherein the suction ports are arranged in-line in the longitudinal direction and the needle advances along a pathway that traverses the suction ports to penetrate captured tissue portions.

14. 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; and

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

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.

15. An endoscopic tissue apposition device as defined in claim 14 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.

16. An endoscopic tissue apposition device as defined in claim 15 wherein the suture tags have sharp distal tips that serve to pierce the tissue during needle advancement.

17. An endoscopic tissue apposition device as defined in claim 15 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.

18. An endoscopic tissue apposition device as defined in claim 17 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.

19. An endoscopic tissue apposition device as defined in claim 17 wherein the lock block further comprises a passage sized to permit suture material to slide through.

20. 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; and

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

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;

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;

wherein four suction ports are provided and arranged in two sets of two on the top and bottom of the capsule.

21. 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; and

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

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;

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.

22. An endoscopic tissue apposition device as defined in claim 21 wherein each suction port is in communication with a dedicated vacuum chamber.

23. An endoscopic tissue apposition device as defined in claim 21 wherein the suture tags have sharp distal tips that serve to pierce the tissue during needle advancement.

24. 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; and

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

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;

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.

25. An endoscopic tissue apposition device as defined in claim 24 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.

26. An endoscopic tissue apposition device as defined in claim 24 wherein the lock block further comprises a passage sized to permit suture material to slide through.

27. 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; and

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

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.

28. 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 through the tissue to secure the tissue portions together, 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.

29. 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 through the tissue to secure the tissue portions together, wherein 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.