Method and device for full thickness resectioning of an organ

• US 6,179,195 B1
• Filed: 05/21/1999
• Issued: 01/30/2001
• Est. Priority Date: 06/19/1998
• Status: Expired due to Term

• Current Assignee: Scimed Life Systems Incorporated (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:
  US09/316,674
• Time in Patent Office: 620 Days
• Field of Search: 227/19, 227/180.1, 227/179.1, 227/176.1, 227/178.1, 606/139, 606/153
• 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, the system comprising:

a flexible endoscope;

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 coupled to the anvil so that the anvil and the stapling head are moveable with respect to one another along an axis substantially parallel to a longitudinal axis of the stapling mechanism 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 in the stapling position;

a position adjusting mechanism for moving 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 operable independently of the staple firing mechanism to cut a portion of tissue received within the gap; 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, wherein the control unit is selectively coupled to the knife to operate the knife independently of the stapling 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, torsionally stiff drive shaft.

3. The full-thickness resectioning system according to claim 1, wherein the stapling head is formed in a proximal housing and includes a plurality of staple slits formed on a distal face thereof and wherein the anvil includes a plurality of staple forming grooves formed on a proximal surface thereof and wherein, when in the stapling position, the staple forming grooves face the staple slits across the gap.

4. The full-thickness resectioning system according to claim 3, wherein the anvil is permanently coupled to the staple head.

5. The full-thickness resectioning system according to claim 3, wherein the staple firing mechanism includes a plurality of staple firing members, each staple firing member being slidably received in a respective one of the staple slits.

6. The full-thickness resectioning system according to claim 5, wherein the control unit further includes a rotatable control member coupled to the stapling mechanism by at least one longitudinally flexible, torsionally stiff drive shaft, the staple slits and the staple forming grooves extending around a portion of a first circle and wherein the staple firing mechanism includes a wedge non-rotatably coupled to the drive shaft for rotation with the drive shaft in a plane adjacent to proximal ends of the staple firing members.

7. The full-thickness resectioning system according to claim 6, wherein the knife cuts tissue along a portion of a second circle concentric with the first circle, a radius of the second circle being smaller than a radius of the first circle.

8. The full-thickness resectioning system according to claim 7, wherein the wedge is rigidly coupled to the knife.

9. The full-thickness resectioning system according to claim 3, wherein at least a portion of the proximal housing is composed of a substantially clear rigid material.

10. The full-thickness resectioning system according to claim 6, wherein the staple slits extend around a portion of the first circle less than 360°

.

11. The full-thickness resectioning system according to claim 6, wherein the staple slits extend around a portion of the first circle less than 270°

.

12. The full-thickness resectioning system according to claim 6, wherein the first circle extends in a plane substantially perpendicular to the longitudinal axis of the stapling mechanism.

13. The full-thickness resectioning system according to claim 6, wherein the knife cuts tissue along a portion of a second circle concentric with the first circle, a radius of the second circle being smaller than a radius of the first circle.

14. The full-thickness resectioning system according to claim 7, wherein the knife is rotatably coupled to the drive shaft so that the drive shaft may rotate independently of the knife and wherein the wedge is selectively coupleable to the knife so that, when coupled to the wedge, the knife is rigidly coupled to the wedge for rotation with the drive shaft and the wedge.

15. The full-thickness resectioning system according to claim 1, wherein a distal surface of the anvil forms a distal most end of the stapling mechanism which, on insertion into the body organ, forms a leading surface thereof and wherein the distal surface of the anvil is tapered.

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

17. The full-thickness resectioning system according to claim 1, wherein the anvil is pivotably coupled to the staple head.

18. The full-thickness resectioning system according to claim 1, further comprising a flexible blade shield cooperating with the knife to cut through the portion of the tissue received within the gap.

19. The full-thickness resectioning system according to claim 18, wherein, when moving between an initial pre-cutting position and a final post-cutting position, the knife cuts the flexible blade shield.

20. The full-thickness resectioning system according to claim 18, wherein the flexible blade shield includes a first portion and a second portion, and wherein, when moving between an initial pre-cutting position and a final post-cutting position, the knife passes between the first and second portions of the flexible blade shield.

26. The method according to claim 20, the stapling mechanism being coupled to a controller which, during operation of the stapling mechanism, remains outside the body of the patient, wherein step of cutting away the portion of tissue to be resectioned includes the sub-steps of:

confirming that the staples have been properly fired into desired locations in the tissue of the body organ;

engaging the knife with the controller; and

operating the controller to draw the knife through the tissue of the body organ to sever the tissue to be resectioned.

21. 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 received around a flexible endoscope into a tubular body organ via a body orifice, wherein the stapling mechanism includes a stapling head and an anvil coupled to one another for movement along an axis substantially parallel to a longitudinal axis of the stapling mechanism 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, the stapling mechanism further includes a knife movably mounted therein;

advancing the stapling mechanism along the endoscope to a portion of wall tissue of the body organ to be resectioned;

moving the stapling mechanism into the tissue receiving position;

drawing the portion of the wall tissue into the gap;

moving the stapling mechanism into the stapling position;

firing a plurality of staples through the tissue received in the gap, wherein the portion of wall tissue into which the staples are fired extends around a longitudinal axis of the body organ by an angle of less than 360°

;

after staple firing has been completed, coupling the knife to the stapling mechanism and operating the knife to cut away from the wall of the body organ the portion of tissue to be resectioned.

22. The method according to claim 21, 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.

23. The method according to claim 22, wherein a longitudinally flexible sheath surrounds the endoscope and the drive shaft.

24. The method according to claim 21, wherein the entire resectioning procedure is performed endoluminally.

25. The method according to claim 24, 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.

27. The method according to claim 25, the controller and the stapling mechanism being coupled together by a torsionally rigid, longitudinally flexible drive shaft wherein, in a first configuration, the knife is disengaged from the drive shaft so that rotation of the drive shaft does not move the knife from an initial position and wherein in a second configuration, the knife is engaged with the drive shaft so that rotation of the drive shaft moves the knife between the initial position and a final position severing the portion of tissue received within the gap.

28. The method according to claim 25, wherein the tissue to be resectioned is drawn into the gap by a grasper device inserted into the gap via a first lumen extending through the stapling mechanism.

29. The method according to claim 28, wherein the grasper device is inserted into the gap via a second lumen extending through a flexible endoscope received within the first lumen.

30. A full-thickness resection device comprising:

a stapling mechanism having an endoscope receiving lumen extending therethrough, wherein, in an operative position, the stapling mechanism is entirely received within a body of a patient, the stapling mechanism comprising;

an anvil;

a stapling head coupled to the anvil so that the anvil and the stapling head are moveable with respect to one another along an axis substantially parallel to a longitudinal axis of the stapling mechanism 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 in the stapling position;

a position adjusting mechanism for moving 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 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 control unit which, when the stapling mechanism is in the operative position, remains outside the body, the control unit being coupled to the stapling mechanism via at least one flexible drive shaft for controlling operation of the position adjusting mechanism and the staple firing mechanism, wherein the drive shaft is selectively coupleable to the knife so that, in a first mode, rotation of the drive shaft does not move the knife and, in a second mode, rotation of the drive shaft moves the knife along a predetermined path.

31. A full-thickness resection device comprising:

a stapling mechanism having an endoscope receiving lumen extending therethrough, wherein, in an operative position, the stapling mechanism is entirely received within a body of a patient, the stapling mechanism comprising;

an anvil;

a stapling head coupled to the anvil so that the anvil and the stapling head are moveable with respect to one another along an axis substantially parallel to a longitudinal axis of the stapling mechanism 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 in the stapling position;

a gear drive for moving 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 moveable cam, motion of which past a plurality of firing pins sequentially fires staples, received in the stapling head adjacent to the firing pins, 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 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 via at least one flexible drive shaft for controlling operation of the position adjusting mechanism, the staple firing mechanism and the knife wherein, in a cutting configuration, the knife is non-rotatably coupled to the drive shaft so that rotation of the drive shaft moves the knife through the gap and in a non-cutting configuration.