This application is a U.S. National Stage Application filed under 35 U.S.C. § 371(a) which claims the benefit of and priority to International Patent Application Serial No. PCT/CN2015/092271, filed Oct. 20, 2015, the entire disclosure of which is incorporated by reference herein.
The present disclosure relates to surgical staplers, and more particularly, to circular staplers including tissue gap indicator assemblies.
Anastomosis is the surgical joining of separate hollow organ sections. In known circular anastomosis procedures, two ends of organ sections are joined by means of a surgical stapler which drives a circular array of staples through each organ section and simultaneously cores any tissue interior of the driven circular array of staples to free a tubular passage. Examples of such devices are described in U.S. Pat. Nos. 7,234,624, 6,945,444, 6,053,390, 5,568,579, 5,119,983, 4,646,745, 4,576,167, and 4,473,077, the content of each of which is incorporated herein by reference in its entirety.
Typically, a circular stapling device has an elongated shaft having a handle portion at a proximal end and a staple cartridge at a distal end. An anvil assembly including an anvil rod with an attached anvil head is mounted to the distal end of the device. The anvil is approximated to clamp tissue between a staple holding component of the staple cartridge and an anvil plate of the anvil assembly. The clamped tissue is stapled by actuation of the handle portion to drive circular arrays of staples through the clamped tissue. Concurrently, an annular knife is advanced by actuation of the handle portion to core tissue inboard of the staple arrays.
Circular stapling devices that have tissue gap indicator assemblies for providing a visual indication of the size of the gap defined between the staple holding component of the staple cartridge and the anvil plate of the anvil assembly are conventional. In such devices, the indicator assembly typically identifies to a clinician when the staple cartridge and the anvil assembly have been approximated within a fire-ready zone, i.e., the zone in which the cartridge assembly and anvil assembly have been approximated sufficiently to allow for the proper formation of staples. Because of the small size of the staples being ejected and thus, the small range of tissue gaps that allow for proper staple formation, visualization of the degree of approximation within the fire-ready zone by a clinician is limited.
It would be advantageous to provide an improved tissue indicator assembly that allows for better visualization of the tissue gap size as the anvil and cartridge assemblies are approximated within the fire-ready zone.
The present disclosure in one aspect is directed to a surgical stapler including a handle assembly having a stationary handle defining a window and a firing trigger. A central body extends distally from the handle assembly and a cartridge assembly is supported on a distal end of the central body. An anvil assembly is supported adjacent the distal end of the central body and is movable in relation to the cartridge assembly between spaced and approximated positions. An approximation mechanism includes a longitudinally movable drive screw that is operatively connected to the anvil assembly such that longitudinal movement of the drive screw effects movement of the anvil assembly in relation to the cartridge assembly between the spaced and approximated positions. The drive screw supports an abutment. An indicator assembly includes a slide and a lever. The slide has indicia visible through the window in the stationary handle. The lever is operatively engaged with the slide and positioned to engage the abutment on the drive screw when the drive screw is moved proximally within the stationary handle to translate longitudinal movement of the drive screw into longitudinal movement of the slide and to effect longitudinal movement of the indicia within the window. The lever is engaged with the abutment and the slide and is configured to translate movement of the abutment over a distance of X1 into movement of the slide over a distance of X2, wherein X2 is greater than X1.
In embodiments, the indicator assembly further includes a biasing member positioned to urge the slide distally within the stationary handle.
In some embodiments, the lever is pivotally mounted within the stationary housing about a post defining a pivot axis and includes an engagement surface positioned to engage the abutment that is spaced from the pivot axis of the post by a distance of R1.
In certain embodiments, the lever includes a protrusion that is operatively engaged with the slide and is spaced from the pivot axis defined by the post by a distance of R2, wherein R2 is greater than R1.
In embodiments, the engagement surface of the lever includes a first engagement member and a second engagement member. The first engagement member is spaced from the pivot axis defined by the post the distance R1 and the second engagement member is spaced from the pivot axis defined by the post a distance R1′, wherein the R1′ is greater than R1 but less than R2.
In some embodiments, the abutment defines a curved abutment surface.
In certain embodiments, the slide has a proximal portion, a central portion, and a distal portion and the central portion defines a channel that receives the lever.
In embodiments, the central portion of the slide defines a vertical groove and the lever includes a protrusion received within the vertical groove. The protrusion is movable within the vertical groove to facilitate longitudinal movement of the slide when the lever is pivoted.
In some embodiments, the biasing member is positioned about the proximal portion of the slide.
In certain embodiments, the indicia is formed on the distal portion of the slide.
In embodiments, the indicia includes a colored line.
In embodiments, the stationary handle defines second indicia positioned about the window, the second indicia being associated with the indicia on the slide to identify to a clinician when the cartridge and anvil assemblies are approximated into a fire-ready zone.
In some embodiments, the approximation mechanism includes a rotation knob that is rotatable in relation to the stationary handle to effect longitudinal movement of the drive screw within the stationary handle.
In certain embodiments, the indicator assembly includes a non-rigid link having a first end attached to a distal end of the lever and a second end attached to a proximal end of the slide.
In embodiments, the link is supported on a support post positioned between the distal end of the lever and the proximal end of the slide.
In some embodiments, the lever is pivotally mounted within the stationary handle about a post defining a pivot axis and includes a proximal end defining an engagement surface. The post is positioned between the proximal and distal ends of the lever. The engagement surface is positioned a distance of R1 from the pivot axis of the post and the distal end of the lever that is attached to the non-rigid link is positioned a distance of R2 from the pivot axis of the post, wherein R2 is greater than R1.
Various embodiments of a surgical stapler including the presently disclosed tissue gap indicator assembly are described herein below with reference to the drawings, wherein:
The presently disclosed surgical stapler will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. In this description, the term “proximal” is used generally to refer to the portion of the apparatus that is closer to a clinician, while the term “distal” is used generally to refer to the portion of the apparatus that is farther from the clinician. In addition, the term “endoscopic” is used generally to refer to endoscopic, laparoscopic, arthroscopic, and any other surgical procedure performed through a small incision or a cannula inserted into a patient's body. Finally, the term clinician is used generally to refer to medical personnel including doctors, nurses, and support personnel.
The presently disclosed surgical stapler includes a handle assembly supporting an indicator assembly that includes an indicator slide and an indicator lever. The handle assembly defines a window that allows for visualization of the indicator slide. The indicator slide has indicia that is visible through the window in the handle assembly. The indicator lever is operatively engaged with the indicator slide to effect movement of the indicator slide from a non-actuated position within the handle assembly to an actuated position within the handle assembly. As the indicator slide moves between the non-actuated position and the actuated position, the indicia on the indicator slide moves beneath the window and provides an indication to a clinician as to the existing tissue gap defined between an anvil assembly and a cartridge assembly and whether the anvil and cartridge assemblies are in a fire-ready zone. In the presently disclosed indicator assembly, the indictor lever interconnects the indicator lever and a drive screw and amplifies to provide movement of the indicator slide to allow a clinician to more easily visualize approximation of the anvil and cartridge assemblies within the firing zone.
Except where otherwise noted, the components of stapler 10 are generally formed from thermoplastics including polycarbonates, and metals including stainless steel and aluminum. The particular material selected to form a particular component will depend upon the strength requirements of the particular component and upon whether the component is a reusable or disposable component. For example, the anvil may be formed from a metal such as stainless steel, whereas portions of handle assembly 12 may be formed from thermoplastic such as a polycarbonate. In addition, the handle assembly 12 may be formed of an autoclavable material to allow for reuse whereas portions of the cartridge assembly may be formed of thermoplastics to allow for disposal. It is envisioned that other materials having the requisite strength requirements which are suitable for surgical use may be used to form the components of surgical stapler 10.
Handle assembly 12 includes a stationary handle 22, a firing trigger 24, an approximation knob 26, an indicator assembly 28, and a lockout mechanism 30. The approximation knob 26 functions to retract and advance a drive screw 40 (
Each of the components of handle assembly 12 identified above are substantially as described in U.S. Pat. No. 7,303,106 (“'106 patent”) entitled “Surgical Stapling Device With Visual Indicator” which issued on Dec. 4, 2007. The '106 patent is incorporated herein by reference in its entirety. Accordingly, only those components of the handle assembly 12 that interact with the presently disclosed indicator assembly will be described in further detail herein. The remaining components and assemblies will not be described in further detail herein.
Referring to
The cartridge assembly 16 is secured to the distal end of central body portion 14 of the surgical stapler 10 and includes a shell or housing 38. The housing 38 supports a pusher (not shown), a knife (not shown), and a staple guide 43 housing one or more rows of staples. Details of the components of the cartridge assembly 16 are provided in the '106 patent which is incorporated herein by reference in its entirety.
Referring to
As discussed above, the lever 54 is supported in the channel 70 of the central portion 62 of the slide 52. The lower portion of the lever 54 is pivotally supported within the housing 44 of the stationary handle 22 by a post 82. The upper portion of the lever 54 supports a pair of radially extending protrusions 84 that are received within the vertical grooves 72 defined in the outer walls defining the channel 70 and spaced from the post 82. The vertical grooves 72 allow for rotatable or pivotal movement of the lever 54 to facilitate longitudinal movement of the slide 52. The lever 54 also defines an engagement surface 86 that is positioned near to the post 82. In embodiments, the engagement surface 86 includes two engagement members 86a and 86b which are described in detail below.
As described above, the approximation knob 26 functions to retract and advance a drive screw 40 to advance or retract the anvil assembly 18 in relation to the cartridge assembly 16 between spaced and approximated positions. A screw stop 90 is fixedly supported on the drive screw 40. The screw stop 90 includes an abutment 92 that is positioned to engage the engagement surface 86 of the lever 54 when the drive screw 40 is moved from an advanced position towards a retracted position to move the anvil assembly 18 and the cartridge assembly 16 from the spaced position towards the approximated position. The abutment 92 has a curved engagement surface 92a that allows the abutment 92 to transition between the first and second engagement members 86a and 86b of the lever 54 as the abutment 92 pivots the lever 54 about the post 82.
Referring also to
As shown in
Referring to
Referring to
Referring to
Referring to
In use, when the drive screw 40 is retracted to approximate the cartridge and anvil assemblies 16, 18 (
Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. It is envisioned that the elements and features illustrated or described in connection with one exemplary embodiment may be combined with the elements and features of another without departing from the scope of the present disclosure. As well, one skilled in the art will appreciate further features and advantages of the disclosure based on the above-described embodiments. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.
Filing Document | Filing Date | Country | Kind |
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PCT/CN2015/092271 | 10/20/2015 | WO | 00 |
Publishing Document | Publishing Date | Country | Kind |
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WO2017/066918 | 4/27/2017 | WO | A |
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