Surgical stapling and cutting device with dual actuating control knob Number:7,419,080 from the United States Patent and Trademark Office (PTO) owispatent A medical device includes a surgical end effector, an end effector control handle, and a control shaft having a longitudinal axis and a handle portion connecting the control shaft to the control handle rotatably about the longitudinal axis. A passive articulation joint connects the end effector to the control shaft. An articulation joint release unlocks the articulation joint when actuated and locks the articulation joint when unactuated. An end effector control device is rotationally fixedly connected to at least a portion of the control shaft to correspondingly rotate the control shaft about the longitudinal axis when the control device is rotated and is longitudinally connected to the joint release to selectively unlock the articulation joint when actuated.<H actuating, stapling, Surgical, stapli, 7419080.html, Patent, pto, 7419080

Title: Surgical stapling and cutting device with dual actuating control knob

Abstract: A medical device includes a surgical end effector, an end effector control handle, and a control shaft having a longitudinal axis and a handle portion connecting the control shaft to the control handle rotatably about the longitudinal axis. A passive articulation joint connects the end effector to the control shaft. An articulation joint release unlocks the articulation joint when actuated and locks the articulation joint when unactuated. An end effector control device is rotationally fixedly connected to at least a portion of the control shaft to correspondingly rotate the control shaft about the longitudinal axis when the control device is rotated and is longitudinally connected to the joint release to selectively unlock the articulation joint when actuated.

Patent Number: 7,419,080 Issued on 09/02/2008 to Smith, et al.

Inventors: Smith; Kevin W. (Coral Gables, FL), Palmer; Matthew A. (Miami, FL), Kline; Korey Robert (Miami, FL), Deville; Derek Dee (Miami, FL)
Assignee: Ethicon Endo-Surgery, Inc. (Cincinnati, OH)

Appl. No.: 11/844,406

Filed: August 24, 2007

Related U.S. Patent Documents


Application Number	Filing Date	Patent Number	Issue Date
11491626	Jul., 2006
60811950	Jun., 2006
60760000	Jan., 2006
60702643	Jul., 2005

Current U.S. Class: 227/175.1 ; 227/175.2; 227/180.1; 227/19; 606/139; 606/219

Current International Class: A61B 17/068 (20060101)

Field of Search: 227/19,176.1,175.1,178.1,180.1 606/139,153,219

References Cited [Referenced By]

U.S. Patent Documents


5465895	November 1995	Knodel et al.
5673840	October 1997	Schulze et al.
5797537	August 1998	Oberlin et al.
6250532	June 2001	Green et al.
6330965	December 2001	Milliman et al.
6644532	November 2003	Green et al.
7059508	June 2006	Shelton et al.

Primary Examiner: Smith; Scott A.
Attorney, Agent or Firm: Mayback & Hoffman, P.A. Mayback; Gregory L. Smiley; Scott D.

Parent Case Text

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional of U.S. patent application Ser. No. 11/491,626, filed Jul. 24, 2006, which parent application claims the priority of U.S. Provisional Patent Application No. 60/702,643 filed Jul. 26, 2005, 60/760,000 filed Jan. 18, 2006, and 60/811,950 filed Jun. 8, 2006, and is related to U.S. patent application Ser. Nos. 11/540,255 and 11/541,105, both filed Sep. 29, 2006, and the entire disclosures of which are hereby incorporated herein by reference in their entireties.

Claims

We claim:

1. A medical device end effector control assembly for connecting an end effector to a control handle, the control assembly comprising: a control shaft having: a longitudinal axis; and a handle portion operable to connect said control shaft to a control handle rotatably about said longitudinal axis; a passive articulation joint operable to connect an end effector to said control shaft; and a rotatable control device: rotationally fixedly connected to at least part of said control shaft to correspondingly rotate said control shaft about said longitudinal axis when said control device is rotated; and longitudinally connected to said articulation joint to selectively unlock said articulation joint when actuated.

2. The device according to claim 1, wherein said control device is longitudinally fixedly connected to said articulation joint to selectively unlock said articulation joint when moved longitudinally along said longitudinal axis.

3. A medical device, comprising: a control handle having a control shaft with a longitudinal axis, said control shaft connected to said control handle rotatably about said longitudinal axis; a surgical end effector connected to said control handle with a passive articulating connection; and a control device: rotationally fixedly connected to at least part of said control shaft to correspondingly rotate said control shaft about said longitudinal axis when said control device is rotated; and longitudinally connected to said passive articulating connection to selectively unlock articulation of said end effector.

4. The device according to claim 3, wherein said surgical end effector is connected to said control shaft with said articulating connection.

5. The device according to claim 3, wherein said control device is longitudinally fixedly connected to said articulating connection to selectively unlock articulation of said end effector when moved longitudinally along said longitudinal axis.

6. The device according to claim 3, wherein: said end effector is rotationally fixedly connected to said control shaft with said articulating connection; and said control device is operable to correspondingly rotate said control shaft and said end effector when said control device is rotated.

7. A medical device, comprising: a control handle having a control shaft with a longitudinal axis, said control shaft connected to said control handle rotatably about said longitudinal axis; a surgical end effector passively articulated with respect to said control shaft and connected through said control shaft to said control handle; and a control device: rotationally fixedly connected to a part of said control shaft to correspondingly rotate said control shaft about said longitudinal axis when said control device is rotated; and operable to selectively unlock passive articulation of said end effector when actuated.

8. The device according to claim 7, wherein said control device is operable to selectively unlock passive articulation of said end effector when moved longitudinally with respect to said control shaft.

9. The device according to claim 7, wherein said control device is operable to correspondingly rotate said control shaft and said end effector when said control device is rotated.

10. A medical device, comprising: a control handle having a first portion of a passive articulation joint with a longitudinal axis, said first portion being rotatable about said longitudinal axis with respect to said control handle; a surgical end effector having a second portion of said passive articulation joint and being connected through said first portion to said control handle for actuation thereby, said first and second portions of said passive articulation joint connecting said end effector to said control handle in a passive articulation; and a control device: rotationally fixedly connected to at least part of said first portion to correspondingly rotate said first portion about said longitudinal axis when said control device is rotated; and longitudinally connected to at least a part of said passive articulating joint to selectively unlock passive articulation of said end effector.

11. The device according to claim 10, wherein said control device is operable to selectively unlock passive articulation of said end effector when moved longitudinally with respect to said first portion.

12. The device according to claim 10, wherein: said end effector is rotationally fixedly connected to said first portion with said passive articulation joint; and said control device is operable to correspondingly rotate said first portion and said end effector when said control device is rotated.

13. A medical device, comprising: an end effector control handle; a control shaft having: a longitudinal axis; and a handle portion connecting said control shaft to said control handle rotatably about said longitudinal axis; a surgical end effector; a passive articulation joint connecting said end effector to said control shaft; an articulation joint release unlocking said articulation joint when actuated and locking said articulation joint when unactuated; and an end effector control device: rotationally fixedly connected to at least a portion of said control shaft to correspondingly rotate said control shaft about said longitudinal axis when said control device is rotated; and longitudinally connected to said joint release to selectively unlock said articulation joint when actuated.

14. The device according to claim 13, wherein: said control shaft has: a distal end; a proximal end; and a handle portion connecting said proximal end of said control shaft to said control handle rotatably about said longitudinal axis; said passive articulation joint connects said end effector to said distal end of said control shaft; and said control device is longitudinally fixedly connected to said joint release to selectively unlock said articulation joint when moved longitudinally along said longitudinal axis.

15. The device according to claim 13, wherein said control shaft is hollow and said joint release passes through said control shaft.

16. The device according to claim 13, wherein said control device is operable to correspondingly rotate said control shaft and said end effector about said longitudinal axis when said control device is rotated.

17. The medical device according to claim 13, wherein said passive articulation joint: articulatingly holds said end effector in position when said articulation joint release is unactuated; and articulatingly releases said end effector when said articulation joint release is actuated.

18. The medical device according to claim 17, wherein said articulation joint release, when actuated, articulatingly releases said end effector to articulate freely.

19. The medical device according to claim 13, wherein: said articulation joint release has an unactuated state and an actuated state; said articulation joint has a locked articulation state and an unlocked articulation state; and said articulation joint release: changes said articulation joint from said locked articulation state to said unlocked articulation state when changed from said unactuated state to said actuated state; and changes said articulation joint from said unlocked articulation state to said locked articulation state when changed from said actuated state to said unactuated state.

20. The medical device according to claim 13, wherein said articulation joint release has an unactuated state and an actuated state and articulatingly releases said passive articulation joint when in said actuated state.

21. The medical device according to claim 20, wherein said end effector articulates when: said articulation joint release is actuated; and an external force is applied to said end effector.

22. The medical device according to claim 13, wherein, when said articulation joint is unlocked, said end effector freely articulates dependent upon external forces acting upon said end effector.

23. The medical device according to claim 13, wherein: said end effector is a surgical stapling end effector having a stapling device with staples and a cutting device with a blade; and said control handle has: a stapler closing actuator closing said stapling device when actuated; and a firing actuator that, when actuated: staples with said stapling device; and cuts with said cutting device; and said stapler closing actuator and said staple firing actuator are different from said articulation joint release.

24. The medical device according to claim 23, further comprising: at least one first flexing device connecting said control handle to said staple firing actuator through said passive articulation joint; at least one second flexing device connecting said end effector to said control handle through said passive articulation joint; and said at least one first flexing device and said at least one second flexing device flexing in a corresponding way to an articulation of said passive articulation joint.

25. The medical device according to claim 13, wherein: said control shaft has a first longitudinal axis; said end effector has a second longitudinal axis; at least one of said control shaft, said end effector, and said passive articulating joint has an alignment device; and said alignment device is operable to bias said end effector to substantially align said first and said longitudinal axes when said articulation joint release is actuated.

26. The medical device according to claim 25, wherein said alignment device is a center-biasing device.

27. The medical device according to claim 13, wherein: said articulation joint release has release teeth; said passive articulation joint has joint teeth interlocked with said release teeth when said articulation joint release is unactuated; and said joint teeth disengage from said release teeth to unlock said passive articulation joint when said articulation joint release is actuated.

28. The medical device according to claim 13, wherein said articulation joint release is a pull-to-release and release-to-relock trigger assembly.

29. The medical device according to claim 13, wherein: said joint release is said portion of said control shaft; and said end effector control device is rotationally fixedly and longitudinally connected to said joint release: to correspondingly rotate said control shaft about said longitudinal axis when said control device is rotated; and to selectively unlock said articulation joint when longitudinally actuated.

30. In a medical device having an end effector coupled to a control handle, an end effector control assembly comprising: a control shaft having: a longitudinal axis; and a handle portion connecting said control shaft to the control handle rotatably about said longitudinal axis; a passive articulation joint connecting an end effector to said control shaft; and an end effector control device: rotationally fixedly connected to at least part of said control shaft to correspondingly rotate said control shaft about said longitudinal axis when said control device is rotated; and longitudinally connected to said articulation joint to selectively unlock said articulation joint when actuated.

31. A medical device, comprising: an end effector control handle having a distal portion; a control shaft having: a longitudinal axis; and a handle portion connecting said control shaft to said control handle rotatably about said longitudinal axis; a surgical stapling end effector having a stapling device with staples and a cutting device with a blade; said control handle having: a stapler closing actuator operable to close said stapling device when actuated; and a staple firing actuator operable to staple said staples with said stapling device and cut with said cutting device when actuated; a passive articulation joint connecting said end effector to said control shaft; an articulation joint release unlocking said articulation joint when actuated and locking said articulation joint when unactuated, said stapler closing actuator and said staple firing actuator being different from said articulation joint release; and a bell-shaped end effector control device: rotationally fixedly connected to at least a portion of said control shaft to correspondingly rotate said control shaft about said longitudinal axis when said control device is rotated; defining an interior disposed about said distal portion of said end effector control handle; and longitudinally connected to said joint release to selectively unlock said articulation joint when actuated.

Description

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

n/a

FIELD OF THE INVENTION

The present invention lies in the field of medical devices, in particular, in the field of surgical stapling instruments that are capable of applying lines of staples to tissue while cutting the tissue between those staple lines and, more particularly, to improvements relating to stapler instruments and improvements in processes for forming various components of such stapler instruments that include an articulating shaft. The device can be used, particularly, for stapling and cutting tissue during endoscopic or laparoscopic surgical procedures.

BACKGROUND OF THE INVENTION

Endoscopic surgical instruments are often preferred over traditional open surgical devices because a smaller incision tends to reduce the post-operative recovery time and complications. Consequently, significant development has gone into a range of endoscopic surgical instruments that are suitable for precise placement of a distal end effector at a desired surgical site through a cannula of a trocar. These distal end effectors engage the tissue in a number of ways to achieve a diagnostic or therapeutic effect (e.g., endocutter, grasper, cutter, staplers, clip applier, access device, drug/gene therapy delivery device, and energy device using ultrasound, RF, laser, etc.).

Positioning the end effector is constrained by the trocar. Generally, these endoscopic surgical instruments include a long shaft between the end effector and a handle portion manipulated by the clinician. This long shaft enables insertion to a desired depth and rotation about the longitudinal axis of the shaft, thereby positioning the end effector to a degree. With judicious placement of the trocar and use of graspers, for instance, through another trocar, often this amount of positioning is sufficient. Surgical stapling and severing instruments, such as described in U.S. Pat. No. 5,465,895 to Knodel et al., are an example of an endoscopic surgical instrument that successfully positions an end effector by insertion and rotation.

One stapler manufactured by United States Surgical Corporation and described in U.S. Pat. Nos. 6,644,532 and 6,250,532 to Green et al. have an end effector that pivotally moves along a single plane in steps dependent upon activation of a lever that correspondingly moves along a single plane in similar steps. See FIGS. 31 and 32 therein. The U.S. Surgical Corp. stapler, however, is limited by the predetermined angles that it can achieve and by the limited side to side pivoting (-45 degrees to +45 degrees) that requires two hands for operation.

Depending upon the nature of the operation, it may be desirable to further adjust the positioning of the end effector of an endoscopic surgical instrument rather than being limited to insertion and rotation. In particular, it is often desirable to orient the end effector at an axis transverse to the longitudinal axis of the shaft of the instrument. The transverse movement of the end effector relative to the instrument shaft is conventionally referred to as "articulation". This articulated positioning permits the clinician to more easily engage tissue in some instances. In addition, articulated positioning advantageously allows an endoscope to be positioned behind the end effector without being blocked by the instrument shaft.

While the aforementioned non-articulating stapling and severing instruments have great utility and may be successfully employed in many surgical procedures, it is desirable to enhance their operation with the ability to articulate the end effector, thereby giving greater clinical flexibility in their use. Articulating surgical instruments generally use one or more firing bars that move longitudinally within the instrument shaft and through the articulation joint to fire the staples from the cartridge and to cut the tissue between the innermost staple lines. One common problem with these surgical instruments is control of the firing bar through the articulation joint. At the articulation joint, the end effector is longitudinally spaced away from the shaft so that the edges of the shaft and end effector do not collide during articulation. This gap must be filled with support material or structure to prevent the firing bar from buckling out of the joint when the single or multiple firing bars is subjected to longitudinal firing loads. What is needed is a support structure that guides and supports the single or multiple firing bars through the articulation joint and bends or curves as the end effector is articulated.

U.S. Pat. No. 5,673,840 to Schulze et al. describes a flexible articulation joint that is formed from an elastomeric or plastic material that bends at the flexible joint or "flex neck". The firing bars are supported and guided through a hollow tube within the flex neck. The flex neck is a portion of the jaw closure mechanism and moves longitudinally relative to the end effector, shaft, and firing bars when the jaws are closed on tissue. The firing bars then move longitudinally within the flex neck as the staples are fired and tissue is cut.

U.S. Pat. No. 5,797,537 to Oberlin et al. (owned by Richard-Allan Medical Industries, Inc.) describes an articulation joint that pivots around a pin, rather than bends around a flex joint. In this instrument, firing bars are supported between a pair of spaced support plates connected at one end to the shaft and at another end to the end effector. At least one of those connections is a slidable connection. The support plates extend through the articulation joint adjacent to the flexible drive member in the plane of articulation such that the support plates bend through the gap in the plane of articulation and the flexible firing bar bends against the support when the tip is articulated in one direction from its aligned position. U.S. Pat. No. 6,330,965 to Milliman et al. from U.S. Surgical teaches the use of support plates that are fixedly attached to the shaft and slidably attached to the end effector.

Although these known support plates guide a firing bar through an articulation joint, it is believed that performance may be enhanced. For instance, it is often desirable for the firing bar to be rapidly accelerated during firing to ensure sufficient momentum for severing tissue effectively. Rigidly attached support plates may tend to dislodge in response, allowing the firing bar to blow out from the articulation joint. As a further example, it is desirable for the instrument to operate in the same manner whether articulated or not. Increased friction when articulated would be inconvenient and distracting to the clinician if required to exert a varying amount of firing force.

Consequently, a significant need exists for an improved articulation mechanism for a surgical instrument mechanism that provides enhanced support to a firing bar through the articulation joint.

BRIEF SUMMARY OF THE INVENTION

It is accordingly an object of the invention to provide a method for operating a surgical stapling and cutting device that overcomes the hereinafore-mentioned disadvantages of the heretofore-known devices and method of this general type.

With the foregoing and other objects in view, there is provided, in accordance with the invention, a medical device end effector control assembly for connecting an end effector to a control handle, the control assembly including a control shaft having a longitudinal axis and a handle portion operable to connect the control shaft to a control handle rotatably about the longitudinal axis, a passive articulation joint operable to connect an end effector to the control shaft and a rotatable control device rotationally fixedly connected to at least part of the control shaft to correspondingly rotate the control shaft about the longitudinal axis when the control device is rotated and longitudinally connected to the articulation joint to selectively unlock the articulation joint when actuated.

With the objects of the invention in view, there is also provided a medical device, including a control handle having a control shaft with a longitudinal axis, the control shaft connected to the control handle rotatably about the longitudinal axis, a surgical end effector connected to the control handle with a passive articulating connection, and a control device rotationally fixedly connected to at least part of the control shaft to correspondingly rotate the control shaft about the longitudinal axis when the control device is rotated and longitudinally connected to the passive articulating connection to selectively unlock articulation of the end effector.

With the objects of the invention in view, there is also provided a medical device, including a control handle having a control shaft with a longitudinal axis, the control shaft connected to the control handle rotatably about the longitudinal axis, a surgical end effector passively articulated with respect to the control shaft and connected through the control shaft to the control handle and a control device rotationally fixedly connected to a part of the control shaft to correspondingly rotate the control shaft about the longitudinal axis when the control device is rotated and operable to selectively unlock passive articulation of the end effector when actuated.

With the objects of the invention in view, there is also provided a medical device, including a control handle having a first portion of a passive articulation joint with a longitudinal axis, the first portion being rotatable about the longitudinal axis with respect to the control handle, a surgical end effector having a second portion of the passive articulation joint and being connected through the first portion to the control handle for actuation thereby, the first and second portions of the passive articulation joint connecting the end effector to the control handle in a passive articulation, and a control device rotationally fixedly connected to at least part of the first portion to correspondingly rotate the first portion about the longitudinal axis when the control device is rotated and longitudinally connected to at least a part of the passive articulating joint to selectively unlock passive articulation of the end effector.

With the objects of the invention in view, there is also provided a medical device, including an end effector control handle, a control shaft having a longitudinal axis and a handle portion connecting the control shaft to the control handle rotatably about the longitudinal axis, a surgical end effector, a passive articulation joint connecting the end effector to the control shaft, an articulation joint release unlocking the articulation joint when actuated and locking the articulation joint when unactuated, and an end effector control device rotationally fixedly connected to at least a portion of the control shaft to correspondingly rotate the control shaft about the longitudinal axis when the control device is rotated and longitudinally connected to the joint release to selectively unlock the articulation joint when actuated.

With the objects of the invention in view, in a medical device having an end effector coupled to a control handle, there is also provided an end effector control assembly including a control shaft having a longitudinal axis and a handle portion connecting the control shaft to the control handle rotatably about the longitudinal axis, a passive articulation joint connecting an end effector to the control shaft, and an end effector control device rotationally fixedly connected to at least part of the control shaft to correspondingly rotate the control shaft about the longitudinal axis when the control device is rotated and longitudinally connected to the articulation joint to selectively unlock the articulation joint when actuated.

With the objects of the invention in view, there is also provided a medical device, including an end effector control handle having a distal portion, a control shaft having a longitudinal axis and a handle portion connecting the control shaft to the control handle rotatably about the longitudinal axis, a surgical stapling end effector having a stapling device with staples and a cutting device with a blade. The control handle has a stapler closing actuator operable to close the stapling device when actuated and a staple firing actuator operable to staple the staples with the stapling device and cut with the cutting device when actuated. A passive articulation joint connects the end effector to the control shaft. An articulation joint release unlocks the articulation joint when actuated and locks the articulation joint when unactuated, the stapler closing actuator and the staple firing actuator being different from the articulation joint release. A bell-shaped end effector control device is rotationally fixedly connected to at least a portion of the control shaft to correspondingly rotate the control shaft about the longitudinal axis when the control device is rotated, defines an interior disposed about the distal portion of the end effector control handle, and is longitudinally connected to the joint release to selectively unlock the articulation joint when actuated.

As used in the art and as used herein, transverse movement of a medical end effector relative to an instrument shaft is conventionally referred to as "articulation." In prior art medical devices having articulation control, the articulation movement is directed actively from the device handle. This active control can be mechanical and/or electrical. For example, some prior art devices have levers at the top of the control handle and, when pivoted left the end effector articulates left and when pivoted right the end effector articulates right. Some operate with opposite movement. To effect this active articulation, it is very difficult for the operator to use only one hand. Thus, often, the operator must hold the handle with one hand and pivot The articulation lever with the other hand. As is known, the trend for laparoscopic and other similar medical devices is to make them operable with a single hand because surgeons often lose control of the device held in the second hand when it is necessary to remove their second hand from that device in order to operate The articulation lever. Loss of device control is undesirable and extends the surgical procedure if the device falls outside the view of the operating surgeon. One prior art device uses electrical measures to actively control articulation. In U.S. Pat. No. 7,213,736 to Wales et al., electrical power is supplied to an electrically actuated polymer to articulate the end effector actively in the desired direction. These prior art devices can be characterized by referring to them as "active articulation" devices, in which an articulation control device is present on the handle and extends though the articulation joint to force the articulation in either articulation direction. In other words, the forces required to perform articulation are generated internally in the device.

The articulation assembly of the present invention has no mechanical control device in the handle to effect direct control of articulating movement of the end effector. There is no articulation control device present on the handle that extends through the articulation joint to force the end effector to articulate in a direction. Instead, articulation of the end effector is dependent upon pressure between a surface of the environment in which the end effector exists and an exterior surface of the end effector, for example, at a location distal of the articulation joint. A torque to pivot the inventive end effector about the articulation axis arises from forces external to the device. One force is present by the user holding the handle. The other force acts distal of the articulation joint and is imparted by the environment in which the end effector is present and against which the end effector is being held. In other words, the forces required to perform articulation are external to the device. This motion can be and is referred to herein as "passive articulation" and the "articulation joint" of the present invention operates with passive articulation--it requires a torque external to the device to articulate the end effector about the axis of the passive articulation joint.

In accordance with another feature of the invention, the control device is longitudinally fixedly connected to the articulation joint to selectively unlock the articulation joint when moved longitudinally along the longitudinal axis.

In accordance with a further feature of the invention, the surgical end effector is connected to the control shaft with the articulating connection.

In accordance with an added feature of the invention, the end effector is rotationally fixedly connected to the control shaft with the articulating connection and the control device is operable to correspondingly rotate the control shaft and the end effector when the control device is rotated.

In accordance with an additional feature of the invention, the control device is operable to selectively unlock passive articulation of the end effector when moved longitudinally with respect to the control shaft.

In accordance with yet another feature of the invention, the control device is operable to correspondingly rotate the control shaft and the end effector when the control device is rotated.

In accordance with yet a further feature of the invention, the end effector is rotationally fixedly connected to the first portion with the passive articulation joint and the control device is operable to correspondingly rotate the first portion and the end effector when the control device is rotated.

In accordance with yet an added feature of the invention, the control shaft has a distal end, a proximal end; and a handle portion connecting the proximal end of the control shaft to the control handle rotatably about the longitudinal axis, the passive articulation joint connects the end effector to the distal end of the control shaft, and the control device is longitudinally fixedly connected to the joint release to selectively unlock the articulation joint when moved longitudinally along the longitudinal axis.

In accordance with yet an additional feature of the invention, the control shaft is hollow and the joint release passes through the control shaft.

In accordance with again another feature of the invention, the passive articulation joint articulatingly holds the end effector in position when the articulation joint release is unactuated and articulatingly releases the end effector when the articulation joint release is actuated.

In accordance with again a further feature of the invention, the articulation joint release, when actuated, articulatingly releases the end effector to articulate freely.

In accordance with again an added feature of the invention, the articulation joint release has an unactuated state and an actuated state, the articulation joint has a locked articulation state and an unlocked articulation state, and the articulation joint release changes the articulation joint from the locked articulation state to the unlocked articulation state when changed from the unactuated state to the actuated state and changes the articulation joint from the unlocked articulation state to the locked articulation state when changed from the actuated state to the unactuated state.

In accordance with again an additional feature of the invention, the articulation joint release has an unactuated state and an actuated state and articulatingly releases the passive articulation joint when in the actuated state.

In accordance with still another feature of the invention, the end effector articulates when the articulation joint release is actuated and an external force is applied to the end effector.

In accordance with still a further feature of the invention, when the articulation joint is unlocked, the end effector freely articulates dependent upon external forces acting upon the end effector.

In accordance with still an added feature of the invention, the end effector is a surgical stapling end effector having a stapling device with staples and a cutting device with a blade and the control handle has a stapler closing actuator closing the stapling device when actuated and a firing actuator that, when actuated, staples with the stapling device and cuts with the cutting device, and the stapler closing actuator and the staple firing actuator are different from the articulation joint release.

In accordance with still an additional feature of the invention, there is also provided at least one first flexing device connecting the control handle to the staple firing actuator through the passive articulation joint, at least one second flexing device connecting the end effector to the control handle through the passive articulation joint, and the at least one first flexing device and the at least one second flexing device flexing in a corresponding way to an articulation of the passive articulation joint.

In accordance with another feature of the invention, the control shaft has a first longitudinal axis, the end effector has a second longitudinal axis, at least one of the control shaft, the end effector, and the passive articulating joint has an alignment device, and the alignment device is operable to bias the end effector to substantially align the first and the longitudinal axes when the articulation joint release is actuated.

In accordance with a further feature of the invention, the alignment device is a center-biasing device.

In accordance with an added feature of the invention, the articulation joint release has release teeth, the passive articulation joint has joint teeth interlocked with the release teeth when the articulation joint release is unactuated, and the joint teeth disengage from the release teeth to unlock the passive articulation joint when the articulation joint release is actuated.

In accordance with an additional feature of the invention, the articulation joint release is a pull-to-release and release-to-relock trigger assembly.

In accordance with a concomitant feature of the invention, the joint release is the portion of the control shaft and the end effector control device is rotationally fixedly and longitudinally connected to the joint release to correspondingly rotate the control shaft about the longitudinal axis when the control device is rotated and to selectively unlock the articulation joint when longitudinally actuated.

In one aspect of the invention, the surgical instrument has a handle portion that releases a lock to allow articulation of the end effector and firing while articulated. The release and firing mechanisms are transferred through a shaft to the articulation mechanism. The articulation mechanism responds to forces that the user imparts to the end effector and allows articulation of the end effector out of line with the longitudinal axis of the shaft. A firing mechanism responds to the firing motion and is coupled for movement through the articulation mechanism and the end effector. A firing support device allows the firing mechanism to support and keep in place the firing mechanism as articulation occurs.

Another advantage of the present invention is that the movable distal end effector is center-biased. This means that the distal end is, first, freed from a stable position and is, then, passively moved into its new position by pressing the end effector against a feature of the environment, such as surrounding tissue. When the actuator that frees the end effector from the stable position is released, the distal end effector returns to its center position under the urging of a center-biasing device, preferably, at least one biasing spring, in particular, two biasing springs imparting a biasing force in opposing and, therefore, centering directions. Alternatively, the center-biasing device can be a set of spring-loaded plungers disposed on either side of the end effector at the clevis to urge the end effector independently towards a center position.

The trigger that controls the passive movement is normally locked. This lock is released by pulling in the trigger. Once the distal end effector is in a desired position, the user releases the trigger, thereby locking distal end effector in the new position.

The device according to the invention is a surgical stapler and cutter or other endoscopic device that can be used, in particular, to staple sections of tissue together and cut tissue when desired. In one embodiment of the end effector, measures for carrying out both the stapling and cutting functions can be entirely contained within the distal end effector of the device.

Again, another advantage of the present invention is that the handle is electronically controlled, universal, and motorized. The handle includes a microprocessor that is programmed for multiple product configurations. For example, in the case of a stapler, the handle is programmed for a 30 mm, a 45 mm, or a 60 mm staple cartridge. The distal shaft of the stapler has a proximal end that plugs into the universal handle. The distal shaft includes an array of electrical contacts that make corresponding contact with a mating array in the handle at the connection location. The contacts are unique for each of the different distal shafts and the handle "recognizes" the shaft and runs the appropriate program for it. The handle is programmed to include logic for safety lockouts, speed of stapler delivery, distance of stroke, and the like. Such modularity allows manufacture of one handle with multiple end effectors to mate thereto.

Actuation of the device is accomplished using an electric motor. The device may also be actuated by multiple electric motors, by hydraulics or pneumatics, or by the transmission of energy through a flexible drive shaft in any way such that the actuation assembly can be contained primarily or entirely in the distal portion of the device.

The work accomplished by any of these measures can be converted into desirable motions through any single or combination of screw drive, gear drive, wedge, toggle, cam, belt, pulley, cable, bearing, or the like push rod. In particular, a screw drive is used to transmit the work of the electric motor into linear motion. In one embodiment, the motor for the screw drive resides in the handle. A flexible rotating cable is connected from the motor to a threaded shaft. Thus, when the motor turns in either direction, the rotation of the flexible cable is transmitted to the threaded drive shaft and, because the stapling actuator and cutting slide is disposed on the drive shaft, both functions are carried out by distal movement of the slide. In a second embodiment, the motor resides entirely in the end effector and has a shaft connected to the slide drive shaft, either directly or through transmission gears. In such a case, all that is needed in the handle is the on/off and drive shaft direction actuators, the former for turning the motor on and off and the latter determining which direction the motor will spin.

The device has a carriage driven by the screw drive to accomplish multiple functions, including closing the stapler jaw, advancing the cutting blade, and firing the staples. The carriage is not the only way to accomplish these tasks. Secondary or multiple work sources may provide the work necessary to accomplish any of these functions.

In the second embodiment of the end effector, the entire stapling and cutting actuation device is self-contained and located distal of a movement joint.

The entire actuation device may be inserted and manipulated by a multi-axis "ball" or "universal" joint that will allow any movement and constraint as desired by the operator. Additionally the entire actuation device may be freed completely from the handle and re-grasped from a different angle to allow greater positional flexibility.

In one aspect of the invention, the instrument actuates an end effector with a longitudinally translating firing mechanism that is supported advantageously through an articulation mechanism by either flanking support plates or a rigid support channel. In the former embodiment, to better respond to firing loads on the firing mechanism, one or more ends of each support plate are resiliently or springedly engaged to one side of the articulation mechanism, and thus are better able to avoid buckling of the firing mechanism. For example, the pair of support plates flanks the firing mechanism across the articulation mechanism, each support plate including an end springedly engaged to a frame recess formed in the articulation mechanism to assist in preventing buckling of the firing mechanism within or out of the articulation mechanism.

In the channel embodiment, the channel floats in the articulation mechanism and has surfaces that support either side of the firing mechanism as articulation occurs in either direction and, thus, avoid buckling of the firing mechanism. The channel has a floor and two sides. The support channel rests freely in a cavity inside the articulation mechanism. Ends of the channel are curved to match curves of the cavity. The support channel has various internal surfaces to contact and support the firing mechanism as it is bent within the articulation mechanism and, thereby, assists in preventing buckling of the firing mechanism within or out of the articulation mechanism.

Thus, various types of actuated diagnostic or therapeutic end effectors may be incorporated into the articulating surgical instrument of the present invention without buckling at the articulation mechanism, even with high firing forces and reduces component dimensions for endoscopic use.

In still a further aspect of the invention, a surgical instrument has a handle portion that produces a closing motion, a firing motion, an articulation mechanism unlocking motion, and an articulation motion, each transferred through a shaft. The end effector includes an elongate channel coupled to the shaft for receiving staples or a staple cartridge therein and an anvil that is pivotally coupled to the elongate channel and that is responsive to the closing motion from the shaft. A firing device has a distally presented cutting edge longitudinally received between the elongate channel and the anvil. The firing device is connected from the handle to the end effector through the shaft and the articulation mechanism. The firing device employs the stapling and carries out a cutting with the firing motion. The articulation mechanism allows movement of the end effector with respect to the shaft. The articulation mechanism is distally coupled to the shaft and permits articulation of the end effector after an articulation lock is removed (i.e., unlocked) and in response to forces that act upon the end effector to cause articulation motion thereof. In other words, when the articulation lock is unlocked, pressure of the end effector against the environment will cause articulation of the end effector with respect to the shaft. To support the firing mechanism, a pair of support plates can flank the firing mechanism across the articulation mechanism, each support plate including an end springedly engaged to a frame recess formed in the articulation mechanism, or a rigid channel can surround the firing mechanism across the articulation mechanism. Thereby, an improved stapling and severing instrument may incorporate a firing device that withstands high firing loads yet does not introduce significantly increased firing forces when articulated.

The actuation device may be manufactured in different lengths and/or manufactured in diameters appropriate for either laparoscopic or endoscopic use, or both. A replaceable staple cartridge can be used. Also, the actuation device can be constructed to attach to a distal end of a flexible endoscope.

A significant advantage of the present invention is that the movement of the end effector is passive and lockable. In other words, the end effector can be unlocked, subsequently moved into a desired position, and, then, caused be retained in the new position--all with a one-handed operation. Endoscopic and laparoscopic surgery requires that the physician be able to use both hands independently. Elimination of this requirement makes such surgeries extremely difficult or not possible. The handle of the present invention has a movement release/lock that can be actuated without the use of a second other hand, enabling a true one-handed operation of the device.

A further advantage of the present invention is that the axial movement of the end effector is discrete and manual. For example, the user can set the axial movement by rotating the distal end effector about the longitudinal axis of the device prior to insertion. This pre-set positioning occurs by pulling the end effector away from the shaft and, then, twisting the distal end effector in the desired direction. This axial movement, in combination with the off-axis movement (side to side) creates a compound angle at the distal end to aid in accurate positioning of the end effector (or even a plurality of end effectors). In another variant, the user can dynamically rotate the distal end effector about the longitudinal axis of the device at any time by providing a rotation device that axially fixedly but rotationally freely connects the handle to the distal components including the shaft, the articulation mechanism, and the end effector. Rotation of the distal components occurs by pulling the bell-shaped rotation device in a direction away from the end effector and, then, rotating the rotation device about the longitudinal axis of the shaft in the desired direction. This rotating movement, in combination with the off-axis movement of the end effector creates a compound angle at the distal end of the device to aid in accurate positioning of the end effector (or even a plurality of end effectors).

Still another advantage of the present invention is that the stapler/cutter can be configured to mount to an end of a standard, flexible endoscope. The controls are back fed through the working channel of the encloseope and mated to the control handle or a control module.

Advantageously, all of the above steps are performed with one-hand.

Other features that are considered as characteristic for the invention are set forth in the appended claims.

Although the invention is illustrated and described herein as embodied in surgical stapling and cutting device with dual actuating control knob, it is, nevertheless, not intended to be limited to the details shown because various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope and range of equivalents of the claims.

The construction and method of operation of the invention, however, together with additional objects and advantages thereof will be best understood from the following description of specific embodiments when read in connection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Advantages of embodiments the present invention will be apparent from the following detailed description of the preferred embodiments thereof, which description should be considered in conjunction with the accompanying drawings in which:

FIG. 1 is an enlarged, fragmentary, perspective view of a first embodiment of a distal stapling and cutting end effector and a portion of a shaft connected thereto according to the invention viewed from a distal end thereof with a staple cartridge approximately pulled out half-way from a staple cartridge jaw of the end effector and with an anvil of the stapler separated from a staple-actuating and tissue-cutting slide;

FIG. 2 is an enlarged, fragmentary, side elevational view of the end effector of FIG. 1 with the distal cowling, the proximal castellation axial movement part, and the cartridge removed for clarity, and with the anvil of the stapler connected to the slide;

FIG. 3 is an enlarged, fragmentary, perspective view of the end effector of FIG. 1 with the staple-actuating and tissue-cutting slide in a distal position but with the anvil of the stapler separated from the slide;

FIG. 4 is an enlarged, fragmentary, perspective view of the end effector of FIG. 1 with the staple cartridge removed from the lower jaw/staple cartridge holder and with the clevis rotated in an approximately 45 degree angle with respect to center;

FIG. 5 is an enlarged, fragmentary, wireframe side elevational view of a distal portion of the end effector of FIG. 1;

FIG. 6 is an enlarged, fragmentary, wireframe perspective view of a castellation axial movement assembly of the end effector of FIG. 1 rotated approximately 90 degrees and with an end effector lateral movement locking pin and a proximal screw removed for clarity;

FIG. 7 is an enlarged, fragmentary, wireframe perspective view of the end effector of FIG. 6 viewed from a bottom thereof with an end effector lateral movement locking pin engaging a tooth of the lateral movement sprocket, and with springs and the proximal screw removed for clarity;

FIG. 8 is an enlarged, fragmentary, wireframe bottom plan view of the end effector of FIG. 7 with an end effector lateral movement locking pin engaging a tooth of the lateral movement sprocket;

FIG. 9 is an enlarged, fragmentary, longitudinal cross-sectional view of the end effector of FIG. 8 viewed from a bottom thereof with the end effector lateral movement locking pin engaging a tooth of the lateral movement sprocket and with the springs removed for clarity;

FIG. 10 is an enlarged, fragmentary, perspective view of the end effector of FIG. 2 rotated about the longitudinal axis with the clevis, the screw, and the distal castellation sleeve axial movement and spring parts removed for clarity;

FIG. 11 is an enlarged, fragmentary, bottom plan view of a distal portion of the end effector of FIG. 1 with the staple-actuating and tissue-cutting slide in a proximal position;

FIG. 12 is an enlarged, fragmentary, bottom plan view of the distal portion of the end effector of FIG. 11 with the staple-actuating and tissue-cutting slide in an intermediate position;

FIG. 13 is an enlarged, fragmentary, radially cross-sectional view through the stapling actuating and tissue-cutting slide of the end effector of FIG. 2;

FIG. 14 is an enlarged, fragmentary, horizontal longitudinal cross-sectional view through a lower half of the end effector of FIG. 1;

FIG. 15 is an enlarged, fragmentary, horizontal longitudinal cross-sectional view through an upper half of a proximal portion of the end effector of FIG. 1;

FIG. 16 is an enlarged, fragmentary, vertical longitudinal cross-sectional view approximately through a longitudinal axis of a proximal portion of the end effector of FIG. 1;

FIG. 17 is an enlarged, fragmentary, vertical longitudinal cross-sectional view through a right half of the proximal portion of the end effector of FIG. 1;

FIG. 18 is an illustration of a left side of the surgical stapler according to the invention with the jaws of the end effector open in an at-rest position of an actuator handle;

FIG. 19 is an illustration of a left side of the surgical stapler of FIG. 18 with the jaws of the end effector closed in an actuated position of a thumb trigger of the actuator handle;

FIG. 20 is an illustration of a left side from above the surgical stapler of FIG. 18 with the lateral movement trigger depressed, with the distal end effector in a laterally free movement state position-dependent upon contact with the environment, such as a surface, and with the jaws of the end effector open in the at-rest position of the actuator handle and laterally positioned at an approximately 45 degree angle;

FIG. 21 is an illustration of a left side from above the surgical stapler of FIG. 18 with the lateral movement trigger in an at-rest state, with the distal end effector in a laterally captured movement state, and with the jaws of the end effector open in the at-rest position of the actuator handle and laterally positioned at an approximately 30 degree angle;

FIG. 22 is a fragmentary illustration of a left side of the end effector of FIG. 18 with the jaws open in the at-rest position and laterally positioned at an approximately 75 degree angle;

FIG. 23 is a fragmentary illustration of a left side of the end effector of the stapler of FIG. 18 with the jaws open in the at-rest position and in a rotated first axial position;

FIG. 24 is a fragmentary illustration of a left side of the end effector of FIG. 23 with the jaws open in the at-rest position and in a normal position rotated counter-clockwise with respect to FIG. 23;

FIG. 25 is a perspective view from a distal end of a second embodiment of a surgical stapling device according to the invention with a removable end effector having a self-contained stapling motor, with the stapling jaws in an at-rest open position and at a right lateral position of approximately 45 degrees, with the ball release lever in an at-rest ball-capture position, and with the motor actuator button in an at-rest motor-off position;

FIG. 26 is an enlarged, perspective view of the removable end effector of FIG. 25 with the jaws in an at-rest open position and with the slide removed for clarity;

FIG. 27 is a perspective view from a distal end of a third embodiment of a surgical stapling device according to the invention with a removable end effector having two ball-connection ends and a self-contained stapling motor, with the stapling jaws in an at-rest open position and at a right lateral position of approximately 45 degrees with staple jaws reversed and facing proximally, with the ball release lever in an actuated ball-released position, and with the motor actuator button in an at-rest motor-off position;

FIG. 28 is an enlarged, perspective view of the removable end effector of FIG. 27 viewed from a right side and a distal end thereof with the jaws in an at-rest open position and with the slide removed for clarity;

FIG. 29 is a fragmentary, enlarged side cross-sectional wireframe view of a distal-most end of an actuating handle of the surgical stapling and cutting device of FIGS. 25 and 26 and of a ball-joint of the removable stapling end effector of FIGS. 25 and 26 in a captured and aligned state;

FIG. 30 is a fragmentary, enlarged side cross-sectional view of a distal-most end of opposite side of the actuating of FIG. 29 with the ball-joint in an un-aligned and released state but still captured in between clamps of the actuating handle;

FIG. 31 is a perspective view from a proximal end of the stapling and cutting device according to the invention with an anvil removed;

FIG. 32 is a fragmentary, perspective view from a proximal end of the device of FIG. 31 with the handle removed to show a proximal portion of an articulation release device with a pushrod therein;

FIG. 33 is an illustration an enlarged, exploded view of parts of the proximal end of an inner tube of the device of FIG. 31;

FIG. 34 is a fragmentary, perspective view from a distal end of interior parts connecting the articulation release device to the articulation joint of the end effector with an outer tube removed;

FIG. 35 is a fragmentary, enlarged, vertically longitudinal cross-sectional view of the parts of FIG. 34;

FIG. 36 is a fragmentary, enlarged, perspective view of a knife guide assembly of the device of FIG. 31 from proximal of a knife guide to distal of a knife blade with outer and inner tubes removed;

FIG. 37 is a fragmentary, enlarged, vertically longitudinal cross-sectional view of a portion of the parts of FIG. 35 at a proximal end of a pullband;

FIG. 38 is a fragmentary, enlarged, vertically longitudinal cross-sectional view of a portion of the parts of FIG. 35 at a distal end of the pullband;

FIG. 39 is a fragmentary, enlarged, side elevational view of a stapler assembly, a drum sleeve, the articulation joint, and a clevis of the device of FIG. 31 with an anvil in an open position;

FIG. 40 is a fragmentary, enlarged, side elevational view of the stapler assembly, the drum sleeve, the articulation joint, and the clevis of the device of FIG. 31 moved distally with respect to FIG. 39 and with the anvil in a closed, firing position;

FIG. 41 is a fragmentary, enlarged, perspective view of a knife guide sub-assembly from proximal of the knife guide to the knife blade with the knife guide,