This application is a U.S. National Stage Application filed under 35 U.S.C. § 371(a) which claims the benefit of and priority of International Patent Application Serial No. PCT/CN2016/073471, filed Feb. 4, 2016, the entire disclosure of which is incorporated by reference herein.
The present disclosure relates to surgical stapling devices, and more particularly, to circular stapling devices that include visual indicator mechanisms for indicating when the surgical stapling device is in a fire-ready zone.
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 stapling device that 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 supported at a proximal end of the shaft and a staple cartridge supported at a distal end of the shaft. An anvil assembly including an anvil rod and an anvil head is also mounted to the distal end of the device. The anvil head is approximated in relation to the staple cartridge to clamp tissue between the staple cartridge and the anvil head of the anvil assembly.
Known surgical stapling devices include an indicator mechanism that provides an indication to a clinician that the anvil head of the anvil assembly has been moved into a firing zone in close approximation with a staple cartridge of the cartridge assembly. The firing zone is the zone of approximation in which the anvil head is positioned in close enough approximation with the staple cartridge to facilitate the proper formation of staples. Due to the small size of the staples being fired and, thus, the limited size of the firing zone, it can be difficult for a clinician to accurately identify using known visual indicator mechanisms exactly where the anvil head is in relation to the staple cartridge in the firing zone.
It would be advantageous to provide a surgical stapling device including a visual indicator mechanism capable of accurately identifying to a clinician the location of the anvil head within the firing zone during approximation of the anvil head and the staple cartridge.
The presently disclosed visual indicator mechanism and surgical stapling device including such a visual indicator mechanism is provided to afford a clinician greater visualization of the movement of an anvil assembly in relation to a cartridge assembly after the anvil and cartridge assemblies have been approximated to within a firing zone, i.e., the zone of approximation in which the anvil head and staple cartridge are in close enough approximation to allow for the proper formation of staples against the anvil assembly. The visual indicator mechanism improves visualization of the different degrees of approximation within the firing zone by providing an indicator cover having spaced slots that allow indicia formed on an indicator member to sequentially appear within the spaced slots to identify the different degrees of approximation within the firing zone. Improving visualization of the position of the anvil head in relation to the staple cartridge of the cartridge assembly during approximation of the anvil head and staple cartridge within the firing zone allows the clinician to better control the degree of approximation to compensate for different tissue thicknesses.
In one aspect of the present disclosure, a surgical stapling device includes a handle assembly having a stationary handle defining a window and a firing trigger. A central body extends distally from the handle assembly. A cartridge assembly is supported on a distal end of the central body and an anvil assembly is supported on the distal end of the stapling device. 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 between advanced and retracted positions effects movement of the anvil assembly in relation to the cartridge assembly between spaced and approximated positions. The drive screw supports an abutment. A visual indicator mechanism includes an indicator cover, an indicator and an indicator plate. The indicator cover is supported on the stationary handle above the window and defines a plurality of spaced slots. The indicator is positioned beneath the indicator cover adjacent the window and supports indicia. An indicator plate is movable from an advanced position to a retracted position within the stationary handle. The indicator plate supports a stop member and has a distal end connected to the indicator. The stop member is positioned to engage the abutment such that movement of the drive screw between the advanced and retracted positions effects movement of the indicator within the indicator cover between first and second positions, wherein the indicia are dimensioned and configured such that movement of the indicator within the indicator cover as the indicator plate is moved from the advanced position to the retracted position causes the indicia to become sequentially visible within the plurality of slots.
In embodiments, the visual indicator mechanism includes a biasing member supported within the stationary handle and positioned to urge the indicator plate towards the advanced position.
In embodiments, the indicia include a plurality of spaced colored bands.
In some embodiments, the plurality of slots includes first, second and third slots, and the plurality of spaced colored bands includes first, second, and third colored bands.
In certain embodiments, when the indicator is in the first position, the first colored band is spaced from the first slot a first distance, the second colored band is spaced from the second slot a second distance, and the third colored band is spaced from the third slot a third distance, wherein the first distance is greater than the second and third distances and the second distance is greater than the third distance.
In embodiments, the first colored band has a first width, the second colored band has a second width and the third colored band has a third width, the first width being less than the second and third widths and the second width being less than the third width.
In some embodiments, the indicator is pivotally supported beneath the indicator cover within the stationary handle.
In certain embodiments, the indicator plate includes a coupling member defining an elongated slot and the indicator includes an engagement member, the engagement member being received within the elongated slot to couple the indicator to the indicator plate.
In embodiments, the indicator plate includes a proximally extending portion and the stationary handle includes a bracket defining a cutout. The proximally extending portion extends through the cutout to guide movement of the indicator plate within the stationary handle.
In some embodiments, the biasing member is positioned in compression about the proximally extending portion between the bracket and a central portion of the indicator plate to urge the indicator plate in a distal direction.
In certain embodiments, the indicia include a stepped colored band and the plurality of slots includes first, second and third slots that are laterally and longitudinally spaced from each other.
In embodiments, the plurality of slots includes first, second and third slots, and the stepped colored band includes first, second, and third steps.
In some embodiments, when the indicator is in the first position, the first step of the colored band is spaced from the first slot a first distance, the second step of the colored band is spaced from the second slot a second distance, and the third step of the colored band is spaced from the third slot a third distance, wherein the first distance is greater than the first and second distances and the second distance is greater than the third distance.
Various embodiments of a surgical stapling device including the presently disclosed visual indicator mechanism are described herein below with reference to the drawings, wherein:
A surgical stapling device including embodiments of the presently disclosed visual indicator mechanism 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 device that is closer to a clinician, while the term “distal” is used generally to refer to the portion of the device that is farther from the clinician. In addition, the term “endoscopic” is used generally to refer to procedures including endoscopic, laparoscopic, and arthroscopic 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 visual indicator mechanism is provided to afford a clinician greater visualization of the movement of an anvil assembly in relation to a cartridge assembly after the anvil and firing assemblies have been approximated to within a firing zone, i.e., the zone of approximation in which the anvil head and staple cartridge are in close enough approximation to allow for the proper formation of staples against the anvil assembly. Improving visualization of the position of the anvil head in relation to the staple cartridge of the cartridge assembly during approximation of the anvil head and staple cartridge within the firing zone allows the clinician to better control the degree of approximation to compensate for different tissue thicknesses.
Except where otherwise noted, the components of stapling device 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 assembly 18 may be formed from metal such as stainless steel, whereas portions of handle assembly 12 may be formed from thermoplastics 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 stapling device 10.
Handle assembly 12 includes a stationary handle 22, a firing trigger 24, an approximation knob 26, a visual indictor mechanism or 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 except for the indicator assembly 28 which is described in detail below, is substantially as described in U.S. Pat. No. 7,303,106 (“the '106 Patent”) which is incorporated herein by reference in its entirety. Only those components of the handle assembly 12 that interact with the presently disclosed indicator assembly 28 will be described in further detail herein.
The anvil assembly 18 includes an anvil shaft or center rod 32 and an anvil head 34. In embodiments, the anvil head 34 is pivotally mounted to the distal end of anvil shaft 32 such that the anvil head 34 can move between an operative non-tilted position and a tilted reduced profile position (not shown). Such an anvil assembly 18 is described in detail in the '106 Patent. Alternately, the anvil assembly 18 may include an anvil head 34 that is fixedly secured to the anvil center rod 32. The anvil head 34 supports an anvil plate 34a that includes a plurality of staple forming depressions (not shown) and is movable into close approximation with the cartridge assembly 16 to deform staples ejected from the cartridge assembly 16.
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 back (not shown), a knife (not shown), and a staple cartridge 38a (
Referring also to
The rotation knob 26 is manually rotated to approximate the anvil assembly 18 and the cartridge assembly 16. More specifically, when the rotation knob 26 is manually rotated in a first direction, the drive screw 40 is moved proximally within the stationary handle 22 from an advanced position towards a retracted position. As discussed above, the lockout mechanism 30 prevents actuation of the firing trigger 24 through an actuation stroke until the anvil assembly 18 is closely approximated with the cartridge assembly 16 to within the firing zone. After the cartridge assembly 16 and the anvil assembly 18 are approximated to within the firing zone, the tissue gap defined between the anvil assembly 18 and the cartridge assembly 16 is further adjustable to accommodate tissues of different thicknesses as described in further detail below.
Referring to
The indicator 60 has a shape that corresponds to the shape of the indicator cover 62 and is pivotally supported within the window 68 of the stationary handle 22 (
In embodiments, the indicator plate 64 includes a body 90 having a distal end defining a coupling member 92, a central portion 94 defining a stop surface 94a, and a proximal end including a proximally extending finger 96. The stop surface 94a is positioned to engage the abutment 52 on the screw stop 50 when the drive screw 40 is retracted within the stationary handle 22 to approximate the cartridge and anvil assemblies 16, 18. The indicator plate 64 is slidably supported within the stationary handle 22, e.g., along grooves defined along inner walls of the stationary handle 22. The coupling member 92 defines a vertically extending elongated slot 98 that receives the engagement member 88 of the indicator 60 and the finger 96 of the indicator plate 64 extends through a bracket 100 defining a cutout 100a defined within the stationary housing 22 to guide movement of the indicator plate 64 between advanced and retracted positions. The biasing member 66, which may be a coil spring, is positioned about the finger 96 between the distal end of the bracket 100 and the proximal end of the central portion 94 of the indicator plate 64 to urge the indicator plate 64 towards the advanced position.
In use, when the rotation knob 26 (
Referring to
When the drive screw 40 is retracted further in the direction indicated by arrow “A” in
When the drive screw 40 is retracted further in the direction indicated by arrow “A” in
As discussed above, the colored bands 84a-c may have different thicknesses. More specifically, to ensure that the colored band 84c remains visible under slot 76c and that the colored band 84b remains visible under slot 76b as the indicator 60 is pivoted through the firing zone, the colored band 84c may have a thickness greater than colored bands 84b and 84a, and the colored band 84b may have a thickness greater than the thickness of colored band 84a.
As shown in
Operation of the indicator assembly 128 is substantially as described above in regard to indicator assembly 28. As such, no further description of the indicator assembly 128 is provided herein.
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/CN2016/073471 | 2/4/2016 | WO | 00 |
Publishing Document | Publishing Date | Country | Kind |
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WO2017/132932 | 8/10/2017 | WO | A |
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