Method and device for full thickness resectioning of an organ

• US 6,126,058 A
• Filed: 06/19/1998
• Issued: 10/03/2000
• Est. Priority Date: 06/19/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Limited (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Adams, Ronald D., Kratsch, Peter K., Sullivan, Roy H. III, Nunez, George A., Main, Lauren O., Buess, Gerhard F., Kortenbach, Jurgen A., Schurr, Marc O., Solar, Matt
• Primary Examiner(s): Vo, Peter
• Assistant Examiner(s): CALVE, JAMES P
• Application Number:
  US09/100,393
• Time in Patent Office: 837 Days
• Field of Search: 227/19, 227/175.1, 227/179.1, 227/180.1, 227/178.1, 227/176.1, 227/76, 606/153, 600/139, 600/140, 600/119
• US Class Current: 227/180.1
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00353 one mechanical instrument performing multiple functions, e.g. cutting and grasping channel for multiple instruments A61B2017/3445; instrument channel A61B2017/22072; replaceable heads A61B2017/2931; suction A61M1/00
• CPC Class Codes: A61B 2017/07214 Stapler heads
• CPC Class Codes: A61B 2017/07221 curved
• CPC Class Codes: A61B 2017/0725 with settable gap between anvil and cartridge, e.g. for different staple heights at different shots
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2090/038 during shipment
• CPC Class Codes: A61B 2090/306 using optical fibres

Abstract

A full-thickness resection system comprises a flexible endoscope and a stapling mechanism, wherein the endoscope is slidably received through at least a portion of the stapling mechanism. The stapling mechanism comprises an anvil and a stapling head mounted to the anvil so that the anvil and the stapling head are moveable with respect to one another between a tissue receiving position and a stapling position and wherein a gap formed between the stapling head and the anvil is larger in the tissue receiving position than it is in the stapling position. A position adjusting mechanism is provided for moving the anvil and the stapling head between the tissue receiving and stapling positions and a staple firing mechanism sequentially fires a plurality of staples from the stapling head across the gap against the anvil and through any tissue received in the gap and a knife cuts a portion of tissue received within the gap. A control unit which remains outside the body is coupled to the stapling mechanism for controlling operation of the position adjusting mechanism and the staple firing mechanism.

Claims

1. A full-thickness resection system for removing a full-thickness portion of a body organ using a flexible endoscope, the system comprising:

a stapling mechanism which, in an operative position is located within a body of a patient, wherein the endoscope is slidably received through at least a portion of the stapling mechanism, the stapling mechanism comprising;

an anvil;

a stapling head rotatably coupled to the anvil so that the anvil and the stapling head may rotate with respect to one another between a tissue receiving position and a stapling position, wherein a gap formed between the stapling head and the anvil is larger in the tissue receiving position than it is in the stapling position;

a position adjusting mechanism for rotating at least one of the anvil and the stapling head relative to the other of the anvil and the stapling head between the tissue receiving and stapling positions;

a staple firing mechanism for sequentially firing, when the stapling head and the anvil are in the stapling position, staples received in the stapling head from the stapling head across the gap against the anvil and through any tissue received in the gap, and

a knife for cutting a portion of tissue received within the gap;

a blade shield attached to said anvil or said stapling head and adapted to define a blade gap through which said blade travels, said blade gap having a width corresponding to a width of said knife, said blade shield disposed to resist movement of a portion of the tissue encountered by said knife, and

a control unit which, when the stapling head is in the operative position, remains outside the body, the control unit being coupled to the stapling mechanism for controlling operation of the position adjusting mechanism and the staple firing mechanism.

2. The full-thickness resectioning system according to claim 1, wherein the control unit includes a rotatable control member coupled to the stapling mechanism by at least one longitudinally flexible drive shaft.

3. The full-thickness resectioning system according to claim 2, wherein, in a first cutting configuration, the knife is coupled to the drive shaft so that rotation of the drive shaft moves the knife from an initial position to a final position severing the portion of tissue received within the gap and wherein in a second non-cutting configuration, the knife is decoupled from the drive shaft so that rotation of the drive shaft does not move the knife between the initial and final positions.

4. The full-thickness resectioning system according to claim 1, wherein the staple firing mechanism includes a plurality of staple firing members, each staple firing member being slidably received in a respective one of a plurality of staple slits.

5. The full-thickness resectioning system according to claim 1, wherein the stapling mechanism includes at least one lumen therethrough for receiving a grasper device.

6. The full-thickness resectioning system according to claim 1, wherein said blade shield is flexible.

7. The full-thickness resectioning system according to claim 1, wherein, when moved from a initial position to a final position, the knife severs the blade shield.

8. The full-thickness resectioning system according to claim 1, wherein the blade shield includes a first portion and a second portion, and wherein the knife passes between the first portion and the second portion.

9. The full-thickness resection system according to claim 1, wherein said plurality of staple slits is formed in at least two parallel rows, wherein the anvil includes a plurality of staple-forming grooves positioned so that, when the anvil and the stapling head are in the stapling position, each of the staple slits is substantially aligned with a respective one of the staple-forming grooves.

10. The full-thickness resection system according to claim 9, wherein the control unit further includes a rotatable control member coupled to a proximal end of the drive shaft.

11. The full-thickness resection system according to claim 10, wherein the knife is selectively coupleable to the drive shaft so that, in a first mode of operation, operation of the knife is independent of the firing of the staples.

12. The full-thickness resection system according to claim 1, wherein the stapling head includes a blade slit extending therethrough and wherein the blade slit and the staple slits extend substantially parallel to the longitudinal axis of the endoscope.

13. The full-thickness resection system according to claim 1, wherein the anvil is coupled to the stapling head via a hinge-pin, and wherein the anvil and the stapling head are moved between the tissue receiving position and the stapling position by rotating about the hinge-pin.

14. A method of performing a full-thickness resection of tissue within a substantially tubular body organ comprising the steps of:

inserting a stapling mechanism slidably coupled to an endoscope into a tubular body organ via a body orifice, wherein the stapling mechanism includes a stapling head and an anvil rotatably coupled to one another for rotation between a stapling position and a tissue receiving position, wherein a gap formed between the stapling head and the anvil is smaller in the stapling position than in the tissue receiving position;

rotating the stapling mechanism into the tissue receiving position,

drawing a section of wall tissue of the body organ to be resectioned into the gap;

rotating the stapling mechanism into the stapling position;

firing a plurality of staples through the tissue received in the gap;

after the staples have been fired cutting away from the wall of the body organ a portion of the section of wall tissue to be resectioned; and

resisting movement of all wall tissue extending inwardly from said plurality of staples during said cutting step, whereby said portion of said wall tissue is completely severed.

15. The method according to claim 14, wherein the stapling mechanism is coupled to a controller by at least one torsionally rigid, longitudinally flexible drive shaft, wherein the controller remains outside the body.

16. The method according to claim 15, wherein a longitudinally flexible sheath surrounds the endoscope and the drive shaft.

17. The method according to claim 14, wherein the entire resectioning procedure is performed endoluminally.

18. The method according to claim 17, wherein the stapling mechanism is maneuvered into a desired position adjacent to the tissue to be resectioned by steering the flexible endoscope through the body organ to locate the tissue to be resectioned visually and then sliding the stapling mechanism along the endoscope to the desired position.