SURGICAL SYSTEM AND SURGICAL METHOD FOR NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY (NOTES)

• US 20110095067A1
• Filed: 04/28/2009
• Published: 04/28/2011
• Est. Priority Date: 04/30/2008
• Status: Active Grant

• Current Assignee: Puequ Co. Ltd.
• Original Assignee: Jichi Medical University
• Inventors: Ohdaira, Takeshi
• Granted Patent: US 8,640,940 B2
• Time in Patent Office: Days
• US Class Current: 227/175.2
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation

Abstract

A system and method for use in NOTES is provided for reducing surgical invasiveness. An insertion body that is connected by an anvil assembly and joined to a thin wire guide or electric guide wire, is inserted via a natural orifice into a hollow organ so as to incise and remove a diseased or defective site from the hollow organ by using a pair of or front-end/rear-end linear cutters of a linear cutting/stapling device or linear stapler, after which the two cut ends of the tract are anastomosed and recovered by a circular anastomosis surgical stapler that is provided with the system.

Claims

1-31. -31. (canceled)

32. A system for use in Natural Orifice Transluminal Endoscopic Surgery, with said system including a circular anastomotic surgical stapler that comprises:

an anvil assembly that has an anvil shaft from which a trocar protrudes rearward along the main axis or X-axis at the rear end of the anvil assembly so that the anvil assembly is used as the front end of the circular anastomotic surgical stapler;

an insertion body that is positioned opposite to the anvil assembly and that includes

(1) a head assembly that has (a) a circular cutter or annular blade for cutting off, in the cylindrical direction, a specified section of a hollow or tubular organ, and (b) one or more annular rows of anastomotic staples for use in circular anastomosis of the two cut-end sections of the remainder of the hollow organ, and

(2) a long, flexible support shaft that is connected to the head assembly;

an operating assembly that is connected to the insertion body and that controls the driving of the circular cutter or annular blade and the anastomotic staples;

a thin guide wire that is inserted via the insertion body and that is connected to the acute or rear end of the trocar so as to be capable of being taken up and released; and

a coupling or engaging mechanism that includes a locked portion and a locking portion that are engageable with each other, with the locked portion provided at the anvil shaft and the locking portion provided at the main axis of the head assembly, and that releasably mounts the anvil assembly to the head assembly, with the insertion body to which the anvil assembly is connected being inserted into the diseased or defective hollow organ via a natural orifice of a living body;

said anvil assembly is detached or removed from the head assembly and is temporarily left at the front-end section of the diseased or defective site of the hollow organ, and the head-assembly-side insertion body retracts to the rear-end section of the diseased or defective site, so as to create a space between the anvil assembly and the head assembly of the insertion body;

after said space has been created between the anvil assembly and the head assembly of the insertion body, there is inserted into the body—

via an endoscopic hole to near the diseased or defective site of the hollow organ, a linear cutting/stapling device or linear stapler that has one or more linear cutters that have a noninterference concave notched structure and that are used to cut off, straight in the transverse direction, only a specified section of the hollow organ without cutting off said thin guide wire, and one or more linear rows of suture staples that are used to staple the respective cut-end sections of the remainder of the hollow organ straight in the transverse direction;

said diseased or defective site of the hollow organ is cut off straight in the transverse direction and removed from the remainder of the hollow organ, and the respective cut-end sections of the remainder of the hollow organ are at the same time closed by purse-string-like linear-stapling suturing straight in the transverse direction by a procedure outside the hollow organ by using the linear stapler; and

then the circular anastomotic surgical stapler performs circular anastomosis of the two cut-end sections of the remainder of the hollow organ, and at the same time cuts off, by a procedure inside the hollow organ, the two cut-end sections that had been closed by purse-string-like linear-stapling suturing of the remainder of the hollow organ, so that the sections are again interconnected;

the thin wire guide is an electric guide wire consisting of an electric conductor, with the front end of the electric guide wire being connected to the acute or rear end of the trocar via a monopolar electrode, with the trocar either consisting of an insulator or being releasably connected to the rear end of the anvil shaft via an insulator, and with the respective purse-string-like linear-stapling suturing sites of the remainder of the hollow organ on the anvil-assembly side and the head-assembly side being (1) cauterized successively by conducting a monopolar current to the monopolar electrode via the electric guide wire that has been taken up, and (2) inserted by the trocar via both of said suturing sites so that said suturing sites will be opened.

34. A system according to claim 32 for use in NOTES, and wherein there are accommodated near the connection between the head assembly and the support shaft:

(a) a push-tube drive mechanism that moves a push tube forward or backward, with the push tube being provided to allow the anvil assembly to connect with or detach from the head assembly, (b) a staple/cutter driver mechanism that drives the anastomotic staples and the circular cutter or annular blade, and (c) a take-up unit that takes up the thin guide wire;

with the operations of the mechanisms and take-up unit being remotely controlled via the operating assembly.

35. A system according to claim 34, for use in NOTES, and wherein a wireless transmitter/receiver and a battery are further provided near the connection between the head assembly and the support shaft, with the push-tube drive mechanism, the staple/cutter driver mechanism, and the take-up unit being controlled by wireless remote control.

36. A system according to claim 32, for use in NOTES, and wherein the coupling or engaging mechanism includes

(1) a locked portion of a convex-shaped anvil shaft that is provided near the trocar;

(2) a split-capture part that is mounted on the center of the head assembly and that is divided circumferentially into a plurality of pieces so as to form a concave shape, and that engageably fits on the locked portion so as to capture the locked portion;

(3) a locking portion, which is provided at the front end of the push tube and is able to move forward and backward so as to allow the anvil assembly to connect with or detach from the head assembly, and that has a plurality of resilient support members that flexurally and elastically support the split-capture part so as to open, without restraint in the diameter-expanding direction, the respective pieces of the split-capture part from the main axis or X0-axis of the head assembly; and

(4) a lock-adjustment tube that fits on the push tube so as to be able to move forward and backward, that acts so that the front end moves forward to the rear end of the locking portion, so as to press the resilient support member from the outside and to close the split-capture part in the diameter-reducing direction, and so that the front end moves backward from the resilient support member so as to open the split-capture part in the diameter-expanding direction.

37. A system according to claim 32, for use in NOTES, and wherein are accommodated near the connection between the head assembly and the support shaft:

(1) a push-tube drive mechanism that moves a push tube forward or backward, with said push tube being provided to allow the anvil assembly to connect with or detach from the head assembly,

(2) a lock-adjustment tube mechanism that moves the lock-adjustment tube forward and backward so as to allow the locking portion to become engaged with and disengaged from the locked portion, and

(3) a staple/cutter driver mechanism that allows the anastomotic staples and the circular cutter or annular blade to be driven or pushed out or retracted;

with the operations of said mechanisms remotely controlled via the operating assembly.

38. A system according to claim 37, for use in NOTES, and wherein a wireless transmitter/receiver and a battery are further provided near the connection between the head assembly and the support shaft, with the push-tube drive mechanism, the lock-adjustment tube mechanism, and the staple/cutter driver mechanism being controlled by wireless remote control.

39. A system according to claim 32, for use in NOTES, and wherein the monopolar electrode is buried in the rear end of the trocar, with a small area of the monopolar electrode being exposed at the outer surface of the rear end of the trocar.

40. A system according to claim 32, for use in NOTES, and wherein the monopolar electrode is exposed in a narrow band-like manner of appropriate length in the axial direction at the outer surface of the rear end of the trocar.

41. A system according to claim 32, for use in NOTES, and wherein the anvil shaft to which the trocar is coupled is also coupled to a rotary means by being rotatably supported by the anvil-shaft support, and is rotated by the rotary means when a monopolar current is conducted to the monopolar electrode.

42. A system according to claim 32, for use in NOTES, and wherein the acute part penetrates both of the purse-string-like linear-stapling suturing sites or on the anvil-assembly side and head-assembly side that are successively cauterized via the trocar, and then is detached or removed from the anvil shaft so as to be pulled into the head assembly.

43. A system according to claim 32, for use in NOTES, and wherein when the anvil assembly is reconnected with the head assembly, the acute part is separated from the rear end of the anvil shaft by pulling the thin guide wire, and after the acute part is withdrawn from the rear-end opening where the push tube is extended to the rearward face of the operating assembly, and wherein there is provided an anvil-assembly connecting aid that (a) is inserted so as to be able to be withdrawn from the rear end of the operating assembly to the front end of the head assembly via the inside of the support shaft, (b) consists of a trocar-like acute part, with the front end thereof being formed like a trocar, penetrating via the split-capture portion of the locking part, (c) has a long flexible shaft that is connected to the trocar-like acute part and that aids the anvil assembly in again being coupled with the head assembly, and (d) assists said connection by inserting the trocar-like acute part that is at the front end of said shaft into the inside of the rear end of the anvil shaft from the acute part of the anvil shaft side has been separated.

44. A system according to claim 32, for use in NOTES, and wherein the anvil assembly contains an anvil-assembly-attitude control mechanism that supports the anvil shaft and that automatically controls the attitude of the anvil assembly in relation to the anvil shaft so that the central or main axis of the anvil shaft substantially corresponds to the main axis of the head assembly or X0-axis.

45. A system according to claim 44, for use in NOTES, and wherein the anvil-assembly-attitude control mechanism includes (a) a biaxial oscillating mechanism that can oscillate along the two axes or Y-axis and Z-axis that meet at right angles with the main axis of the anvil shaft or X-axis, (b) angle sensors, mounted on the connection of the anvil shaft, for the Y-axis and Z-axis, and (c) a drive means that drives the biaxial oscillating mechanism along the Y-axis and Z-axis, respectively.

46. A system according to claim 45, for use in NOTES, and wherein the biaxial oscillating mechanism consists of a gimbal mechanism in which a second frame able to oscillate along the Y-axis is provided on a first frame that is fixed inside the anvil assembly, and an anvil-shaft support able to oscillate along the Z-axis and supporting the anvil shaft is provided on the second frame.

50. A system according to claim 32 for use in NOTES, and wherein there is provided a wireless endoscope device or capsule endoscope device, with the front-end assembly of the endoscope arranged in the vicinity of the front end of the head assembly.

33. A system for use in NOTES, with said system including a circular anastomotic surgical stapler that comprises:

an anvil assembly to whose rear end is connected an anvil shaft whose rear end connects releasably to an acute part that includes a trocar, so that said anvil shaft protrude rearward along the main axis or X-axis so that the anvil assembly is used as the front end of the circular anastomotic surgical stapler;

an insertion body that is positioned opposite to the anvil assembly and that includes (a) a head assembly that has (1) a circular cutter or annular blade for cutting off in the cylindrical direction a specified section of the hollow or tubular organ, (2) one or more annular rows of anastomotic staples that are used in circular anastomosis of the two cut-end sections of the remainder of the hollow organ, and (b) a long, flexible support shaft that is connected to the head assembly;

an operating assembly that is connected to the insertion body and that controls the driving of the circular cutter or annular blade and one or more rows of anastomotic staples;

a thin guide wire that is inserted via the insertion body and that is connected to the acute or rear end of the trocar so as to be capable of being taken up and released; and

a coupling or engaging mechanism that includes a locked portion and a locking portion that are engageable with each other, with the locked portion provided at the anvil shaft and the locking portion provided at the main axis of the head assembly, and that releasably mounts the anvil assembly to the head assembly;

and wherein said system the insertion body to which the anvil assembly is connected is inserted via a natural orifice of the body into the hollow organ that has a diseased or defective site;

said anvil assembly is detached or removed from the head assembly and is temporarily left at the front end of the diseased or defective site of the hollow organ, and the head-assembly-side insertion body retracts to the rear-end portion of the diseased or defective site, so as to create a space between the anvil assembly and the insertion body;

after said space has been created between the anvil assembly and the insertion body, there are inserted into the body at the diseased or defective site of the hollow organ via an endoscopic hole, a linear stapler that has one or more linear cutters that have a noninterference concave notched structure and that are used to cut off, straight in the transverse direction, only a specified section of the hollow organ without cutting off said thin guide wire, and one or more linear rows of suture staples that are used to staple the respective cut-end sections of the remainder of the hollow organ straight in the transverse direction;

said diseased or defective site of the hollow organ is cut off straight in the transverse direction and removed from the remainder of the hollow organ, and at the same time the respective cut-end sections of the remainder of the hollow organ are closed by purse-string-like linear-stapling suturing straight in the transverse direction by a procedure outside the hollow organ using the linear stapler; and

then

said circular anastomotic surgical stapler performs circular anastomosis of the two cut-end sections of the remainder of the hollow organ, and at the same time cuts off the two cut-end sections that have been closed by purse-string-like linear-stapling suturing of the remainder of the hollow organ by a procedure inside the hollow organ, so that the sections are again interconnected;

the thin wire guide is an electric guide wire consisting of an electric conductor, with the front end of the electric guide wire being connected to the acute or rear end of the trocar via a monopolar electrode,

with the trocar either consisting of an insulator or being releasably connected to the rear end of the anvil shaft via an insulator,

and with the respective purse-string-like linear-stapling suturing sites of the remainder of the hollow organ on the anvil-assembly side and the head-assembly side being (1) cauterized successively by conducting a monopolar current to the monopolar electrode via the electric guide wire that has been taken up, and (2) said respective purse-string-like linear-stapling suturing sites inserted by the trocar via both of said suturing sites so that said suturing sites will be opened.

51. A system for use in NOTES, with said system including a circular anastomosis surgical stapler that comprises:

an anvil assembly that has an anvil shaft from which a trocar protrudes rearward along the main axis or X-axis at the rear end of the anvil assembly so that the anvil assembly is used as the front end of the circular anastomotic surgical stapler;

an insertion body that is positioned opposite to the anvil assembly and that includes

(1) a head assembly that has (a) a circular cutter or annular blade for cutting off, in the cylindrical direction, a specified section of a hollow or tubular organ, and (b) one or more annular rows of anastomotic staples for use in circular anastomosis of the two cut-end sections of the remainder of the hollow organ, and

(2) a long, flexible support shaft that is connected to the head assembly;

an operating assembly that is connected to the insertion body and that controls the driving of the circular cutter or annular blade and the anastomotic staples;

a thin guide wire that is inserted via the insertion body and that is connected to the acute or rear end of the trocar so as to be capable of being taken up and released; and

a coupling or engaging mechanism that includes a locked portion and a locking portion that are engageable with each other, with the locked portion provided at the anvil shaft and the locking portion provided at the main axis of the head assembly, and that releasably mounts the anvil assembly to the head assembly, with the insertion body to which the anvil assembly is connected being inserted into the diseased or defective hollow organ via a natural orifice of a body;

and wherein there is further provided (1) an anvil-assembly connecting aid that consists of a long, flexible, hollow shaft whose two ends are open and via which the rear end of the anvil shaft and the trocar portion can be inserted, and (2) a holding part that is provided at the rear end of the hollow shaft and that is inserted into the hollow organ under the condition that the rear end of the anvil shaft and the trocar portion are inserted into the front end of the hollow shaft so that the anvil assembly is coupled to the anvil-assembly connecting aid;

said anvil assembly inserting aid to which said anvil assembly is connected is inserted into the hollow organ having a diseased or defective site through a natural orifice of the body;

said anvil assembly is detached or removed from said anvil-assembly inserting aid and is temporarily left near the front-end section of the diseased or defective site of the hollow organ, and said anvil-assembly inserting aid retracts to the rear-end section of said diseased or defective site, so as to create a space between the anvil assembly and said insertion body;

after said space has been created between said anvil assembly and said anvil-assembly inserting aid, a linear-cutting/stapling device or linear stapler that has one or more linear cutters that have a noninterference concave notched structure, and that are used to cut off, straight in the transverse direction, only a specified section of the hollow organ without cutting off said thin guide wire, and one or more linear rows of suture staples that are used to staple the respective cut-end sections of the remainder of the hollow organ straight in the transverse direction;

said diseased or defective site of the hollow organ is cut off, straight in the transverse direction, and is then removed from the remainder of the hollow organ, and, at the same time, the respective cut-end sections of the remainder of the hollow organ are closed by purse-string-like linear-stapling suturing straight in the transverse direction by a procedure outside the hollow organ by using said linear stapler; and

then,

said anvil-assembly inserting aid retracts from the remainder of the intestinal tract on the head assembly side, and is withdrawn from the natural orifice of the body;

said insertion body on the head assembly side is inserted from a natural orifice of the body to near the site of the purse-string-like linear-stapling suturing of the remainder of the hollow organ on the head assembly side,

said circular anastomosis surgical stapler performs circular anastomosis of said two cut-end section of the remainder of the hollow organ, and at the same time cuts off said two cut-end sections that had been closed by purse-string-like linear-stapling suturing of said remainder of the hollow organ so that said sections are rehabilitated again in a normal interconnected condition;

the thin wire guide is an electric guide wire consisting of an electric conductor, with the front end of the electric guide wire being connected to the acute (rear) end of the trocar via a monopolar electrode,

with the trocar consisting of an insulator or formed separately on the anvil shaft via an insulator,

and with both of the purse-string-like linear-stapling suturing sites of the remainder of the hollow organ on the anvil-assembly side and the head-assembly side being (1) cauterized successively by conducting a monopolar current to the monopolar electrode via the electric guide wire that has been taken up, and (2) inserted by the trocar via both of said suturing sites so that said suturing sites will be opened.

52. A system for use in NOTES that includes a linear cutting/stapling device that comprises:

(1) an insertion body to be inserted into a body via an endoscopic hole so that endoscopic instruments can be inserted into said body, with the insertion body including (a) an end effector that has one or more linear rows of suture staples that are positioned opposite to one jaw of the end effector that opens and closes, linearly stapling in the straight transverse direction on the outside of the hollow organ a specified section of the hollow organ, and the other jaw of said end effector provided with a pair of linear cutters for cutting off in the transverse direction a specified section of the hollow organ, with the cutters capable of respectively moving back and forth from the respective sides of the front end and rear end of sad other jaw to an intermediate area thereof, and (b) a long, flexible support shaft that is connected to the end effector; and

(2) an operating assembly that controls the driving of the linear rows of suture staples and the linear cutters;

and wherein the circular anastomotic surgical stapler includes

(a) an anvil assembly that has an anvil shaft on which a trocar protrudes rearward along the main axis or X-axis at the rear end of the anvil assembly so that the anvil assembly is used as the front end of the circular anastomosis surgical stapler;

(b) an insertion body, positioned opposite to the anvil assembly and including a head assembly that has [1] a circular cutter or annular blade for cutting off, in the cylindrical direction, a specified section of a hollow or tubular organ, and [2] one or more annular rows of anastomotic staples for use in circular anastomosis of the two cut-end sections of the remainder of the hollow organ, and a long, flexible support shaft that is connected to the head assembly;

(c) an operating assembly that is connected to the insertion body and that controls the driving of the circular cutter or annular blade and anastomotic staples,

(d) a coupling or engaging mechanism that includes a locked portion and a locking portion that are engageable with each other, with the locked portion provided at the anvil shaft and the locking portion provided at the central (main) axis of the head assembly, and that releasably mounts the anvil assembly to the head assembly, and

(e) an insertion body, to which the anvil assembly is connected, which is inserted into the hollow organ that has a diseased or defective site, via a natural orifice of the body under the condition that the anvil assembly is detached from the head assembly and temporarily remains near the front end of the diseased or defective site, and the head-assembly-side insertion body retracts to near the rear end of the diseased or defective site, so as to create a space between the anvil assembly and the head assembly;

after said space has been created between the anvil assembly and the head assembly, the linear stapler is inserted into the body via an endoscopic hole near the diseased or defective site of the hollow organ, and the front-end and rear-end sections of the diseased or defective site are successively cut off straight in the transverse direction and removed from the remainder of the hollow organ by using a pair of linear cutters, and at the same time the two cut-end sections of the remainder of the hollow organ are closed by purse-string-like linear-stapling suturing straight in the transverse direction by a procedure outside of the hollow organ using the linear stapler.

53. A system according to claims 52, for use in NOTES, and wherein the pair of linear cutters of the end effector move back and forth in the direction opposite to each other due to the linear-staple/cutter-driving mechanism provided inside the other jaw.

54. A system according to claim 53, for use in NOTES, and wherein the linear-staple/cutter-driving mechanism includes a linear staple/cutter driver shaft that (1) is rotatably provided inside a channel dug facing the rear of the staple cartridge in which one or more linear rows of suture staples are accommodated, (2) is removably fit inside the other jaw or unmovable jaw facing the one jaw or opening/closing jaw, and (3) has a male screw on which reverse screws in the right and left directions are formed on either the anterior half and or the posterior half of the male screw;

and

front-end and rear-end staple-driving mechanisms, both of which (1) have a wedge mechanism that is threadedly engaged with the respective left and right reverse screws of the linear-staple/cutter-driving mechanism, and (2) move back and forth in the direction opposite to each other inside the channel accompanying the reversible rotation of the linear staple/cutter driver shaft, so as to drive the one or more linear rows of suture staples; and

wherein

the pair of linear cutters are mounted on the respective front-end and rear-end staple-driving mechanisms in such a way that the pair of linear cutters are driven or disposed so that the blade edges thereof are positioned opposite to each other and standing in the direction of the staple cartridge.