Patent Application
20220287716
This technology is generally related to surgical stapling devices and, more particularly, to a surgical stapling device for performing end-to-end anastomosis that has structure on an anvil assembly to indicate to a clinician if tissue was gripped consistently about the anastomotic site during an anastomosis procedure.
Circular stapling devices are commonly used to perform anastomoses during surgical procedures. Anastomosis is the surgical connection of two body lumens, e.g., blood vessels, intestine, etc. Leaks in an anastomosis can lead to bleeding and result in infection which may result in life-threatening complications. As such, it is common practice for a clinician to examine an anastomotic donut formed during the anastomosis procedure after the anastomosis procedure is completed to verify that there are no leaks or bleeding. Examination of the anastomotic donut typically requires an endoscopy procedure which is performed after the anastomosis procedure has been performed. This adds cost and time to the anastomosis procedure.
During a colectomy procedure, a portion of the gastrointestinal (GI) tract is resected and GI tract sections on opposite sides of the resected tract section are rejoined to form the anastomotic donut. This procedure is conducted within the GI tract and is performed without visualization of the anastomotic site. As such, a clinician, e.g., a surgeon, typically inspects the anastomotic donut after the anastomosis procedure is completed. This inspection requires preparing a colonoscope and visualization capabilities and poking an end of the colonoscope into the freshly resected and stapled tract sections to determine if the anastomotic donut is properly formed and free from leaks. If the anastomotic donut is not properly formed, the inspection risks perforation of the anastomosis. In addition to the risk of perforation, the inspection increases operating time and requires significant surgical skill and staff coordination to complete.
A continuing need exists in the art for a safer, less time-consuming way to evaluate the effectiveness of the anastomosis after an anastomosis procedure has been performed.
This disclosure is directed to a circular stapling device for performing anastomosis procedures that includes an anvil assembly and a reload assembly that supports a staple cartridge. The anvil assembly has an anvil head that includes an anvil surface with staple forming pockets that are coated with a plurality of layers of materials having different colors. The colors that are exposed after the stapling device is fired provides an indication to a clinician of whether tissue clamped between the anvil assembly and the reload assembly was clamped in an optimal fashion or in a sub-optimal fashion.
Aspects of this disclosure are directed to an anvil assembly including an anvil shaft, an anvil head, and a plurality of layers of coating material. The anvil shaft has a proximal portion and a distal portion. The anvil head has an anvil surface that defines staple forming pockets. The plurality of layers of coating material is positioned on the anvil surface within the staple forming pockets and includes an inner layer having a first color and an outer layer having a second color that is different from the first color. The outer layer is positioned over the inner layer.
Another aspect of the disclosure is directed to an anvil assembly that includes an anvil shaft, an anvil head, and a plurality of layers of coating material. The anvil shaft has a proximal portion and a distal portion. The anvil head has an anvil surface that defines staple forming pockets. The plurality of layers of coating material is positioned on the anvil surface within the staple forming pockets. Each of the plurality of layers of coating material is formed of color coated metal. The plurality of layers of coating material includes an inner layer having a first color, a middle layer having a second color, and an outer layer having a third color. Each of the first, second, and third colors is different from the others.
In aspects of the disclosure, the plurality of layers of coating material includes a middle layer that has third color that is different than the first and second colors and is positioned between the inner and outer layers.
In some aspects of the disclosure, the plurality of layers of coating material are formed from color coated metals.
In certain aspects of the disclosure, the anvil head includes a central post that is secured to the proximal portion of the anvil shaft by a pivot member.
In aspects of the disclosure, the proximal portion of the anvil shaft is configured to be releasably coupled to a surgical stapling device.
In some aspects of the disclosure, the plurality of layers of coating material is applied to the anvil surface within the staple forming pockets by vapor deposition.
In certain aspects of the disclosure, inner layer has a thickness of from about 0.3 mm to about 0.5 mm, the middle layer has a thickness of from about 0.3 mm to about 0.5 mm, and outer layer has a thickness of from about 0.3 mm to about 0.5 mm.
In aspects of the disclosure, each of the staple forming pockets includes first and second pocket portions and a linear portion, and the linear portion extends between and interconnects the first and second pocket portions.
Other aspects of the disclosure are directed to a surgical stapling device that includes an elongate body, a reload assembly, and an anvil assembly. The elongate body has a proximal portion and a distal portion. The reload assembly is supported on the distal portion of the elongate body and includes a shell housing, a staple cartridge, staples supported within the staple cartridge, and a pusher. The pusher is movable within the shell housing from a retracted position to an advanced position to eject the staples from the staple cartridge. The anvil assembly includes an anvil shaft, an anvil head, and a plurality of layers of coating material. The anvil shaft has a proximal portion and a distal portion. The anvil head has an anvil surface that defines staple forming pockets. The plurality of layers of coating material are positioned on the anvil surface within the staple forming pockets and includes an inner layer having a first color and an outer layer having a second color that is different from the first color. The outer layer is positioned over the inner layer.
In aspects of the disclosure, the reload assembly includes a cutting blade that is supported on the pusher.
In some aspects of the disclosure, a handle assembly is coupled to the proximal portion of the elongate body.
Other features of the disclosure will be appreciated from the following description.
Various aspects of the disclosure are described herein below with reference to the drawings, wherein:
The disclosed circular stapling device 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. However, it is to be understood that the aspects of the disclosure are merely exemplary of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the disclosure in virtually any appropriately detailed structure.
In this description, the term “proximal” is used generally to refer to that portion of the device that is closer to a clinician, while the term “distal” is used generally to refer to that portion of the device that is farther from the clinician. In addition, the term “clinician” is used generally to refer to medical personnel including surgeons, doctors, nurses, and support personnel. In addition, directional terms such as front, rear, upper, lower, top, bottom, and similar terms are used to assist in understanding the description and are not intended to limit the disclosure.
This disclosure is directed to a circular stapling device for performing anastomosis procedures that includes an anvil assembly and a shell assembly that supports a staple cartridge. The anvil assembly has an anvil head that includes an anvil surface with staple forming pockets that are coated with a plurality of layers of materials having different colors. The staple cartridge supports a plurality of staples. When the stapling device is fired, legs of staples are received and formed within the staple forming pockets of the anvil surface and penetrate one or more of the layers of materials. The trajectory of the staple legs as the staple legs are formed is affected by a resistance of tissue clamped between the staple cartridge and the anvil plate. More specifically, the amount of tissue and the type of tissue clamped between the staple cartridge and the anvil plate will affect the trajectory of the staple legs as the staple legs are advanced through the tissue and are formed within the staple forming pockets. If a large amount of tissue and/or tissue having a high tensile strength is clamped between the staple cartridge and the anvil plate, the staple legs will take a shallow trajectory through the layer or layers of materials coating the staple forming pockets as the staple legs are formed. Conversely, if a lesser amount of tissue and/or tissue having a low tensile strength is clamped between the staple cartridge and the anvil plate, the staple legs will take a deep trajectory through the layers of materials coating the staple forming pockets. After a surgical procedure, a clinician can inspect the exposed colored layers of coating within the staple forming pockets of the anvil plate to determine whether an adequate amount of tissue and/or the correct type of tissue was clamped between the staple cartridge and the anvil plate to form an anastomosis. Based on the results of this inspection, a need for inspection of the anastomosis using a colonoscope may be obviated.
The stapling device 10 is illustrated as a powered stapling device and includes an electrically powered handle assembly 12 that may support one or more batteries (not shown). The elongate body 14 is in the form of an adaptor assembly that translates power from the handle assembly 12 to the reload and anvil assemblies 16 and 18, respectively. Examples of electrically powered stapling devices can be found in U.S. Pat. Nos. 9,055,943, 9,023,014, and U.S. Publication Nos. 2018/0125495, and 2017/0340351. Alternately, it is envisioned that the stapling device 10 could also be a manually powered stapling device such as disclosed in U.S. Pat. No. 7,303,106 (the '106 patent) or a stapling device that is configured for use with a robotic system such as disclosed in U.S. Pat. No. 9,962,159 that does not include a handle assembly.
The anvil head 32 includes a central post 32a and an annular anvil surface 42 that faces the reload assembly 16 (
The colored materials forming the layers 70, 72, and 74 are applied to the walls defining the staple forming pockets 44 in a manner to facilitate removal of one or more of the layers 70, 72, and 74 from the staple forming pockets 44 upon engagement with the distal ends of the staple legs 50a of the staples 50. The colored materials of each of the layers 70, 72, and 74 can be applied to the walls defining the staple forming pockets 44 using a variety of different techniques including brushing, vapor deposition, or the like. In aspects of the disclosure, layer 70 has a thickness of from about 0.3 mm to about 0.5 mm, layer 72 has a thickness of from about 0.3 mm to about 0.5 mm, and layer 74 has a thickness of from about 0.3 mm to about 0.5 mm. In some aspects of the disclosure, one or more of the layers 70, 72, and 74 can be scratched off the walls defining the staple forming pockets 44 by engagement with the distal ends of the staple legs 50a upon firing of the stapling device 10 (
In aspects of the disclosure, the anvil surface 42 of the anvil head 32 defines a plane “P” and each of the layers 70, 72, and 74 of colored material is positioned within the staple forming pocket 44 at a different distance from the plane “P”. The first layer 70 has a proximal-most surface that has the shallowest depth “dmin” within the staple forming pocket 44, the anvil surface 42 upon which the third layer 74 of colored material is applied defines the deepest depth “dmax” within each of the staple forming pockets 44, and the second and third layers 72 and 74 of colored materials have proximal-most surfaces that are positioned at different depths within the staple forming pocket 44 between “dmax” and “dmin”.
The resistance exerted on the staple legs 50a by the tissue clamped between the staple cartridge 61 and the anvil surface 42 will affect the trajectory of formation of the staple legs 50a within each of the staple forming pockets 44 of the anvil head 32 of the anvil assembly 18. More specifically, the amount of tissue and the type of tissue clamped between the staple cartridge 61 and the anvil surface 42 of the anvil head 32 will affect the trajectory of formation of the staple legs 50a as the staple legs 50a are advanced through the tissue and formed within the staple forming pockets 44. If a large amount of tissue and/or tissue having a high tensile strength is clamped between the staple cartridge 61 and the anvil surface 42, the staple legs 50a will take a shallow trajectory through the layer or layers of materials 70, 72, and 74 coating the staple forming pockets 44 as the staple legs 50a are formed. Conversely, if a lesser amount of tissue and/or tissue having a low tensile strength is clamped between the staple cartridge 61 and the anvil surface 42, the staple legs 50a will take a deep trajectory through the layers of materials 70, 72, and 74 coating the staple forming pockets 44.
During an anastomosis procedure, first and second tracts 80 and 82 of a vessel “V”, e.g., the colon, are reconnected after a diseased portion (not shown) of the vessel “V” has been resected. As shown, the stapling device 10 is inserted into a lumen “L” defined by the two tracts 80 and 82 with the anvil head 32 of the anvil assembly 18 positioned in the first tract vessel 80 and the reload assembly 16 positioned in the second tract 82 of the vessel “V”. The anvil head 32 is approximated towards the shell assembly 16 to clamp ends 80a and 82a of the two tracts 80 and 82 between the anvil surface 42 of the anvil head 32 and the staple cartridge 61 of the reload assembly 16. When the anvil head 32 of the anvil assembly 18 and the staple cartridge 61 of the reload assembly 16 are in a clamped position, each of the staple forming pockets 44 of the anvil head 32 is aligned with a respective one of the staple receiving slots 62 of the staple cartridge 61 such that the staples 50 ejected from the staple cartridge 61 are formed into a substantially B-shape through both ends 80a and 80b of the first and second vessel tracts 80 and 82, respectively.
The colon is comprised of four types of tissue including mucosa, submucosa, muscularis, and serosa. For optimal anastomotic integrity, the muscularis and submucosal tissue of both first and second vessel tracts 80 and 82 must be clamped or gripped between the staple cartridge 61 of the reload assembly 16 and the anvil surface 42 such that the staples 50 are forced through these tissues. This is necessary because the muscularis and submucosa have the greatest tensile strength and are less resistant to tearing. Where only mucosal tissue is clamped between the staple cartridge 61 of the reload assembly 16 and the anvil surface 42, an anastomotic donut 90 (
After the anastomosis procedure, a clinician can remove the stapling device 10 from the vessel “V” of the patient and inspect the anvil surface 42. If the exposed portions of the anvil pockets 44 within the staple forming pockets 44 are a uniform color, e.g., yellow or green, this provides an indication to a clinician that the ends 80a and 80b of the first and second vessel sections 80 and 82 were clamped in optimal fashion and that there is a high probability the anastomotic donut 90 is sound and no leakage exists at the anastomotic site. In such an instance, a clinician may decide that further inspection of the anastomotic donut 90 is not warranted.
After the anastomosis procedure, a clinician can remove the stapling device 10 from the vessel “V” of the patient and inspect the anvil surface 42. If the anvil pockets 44 show the color of the third layer 74 of the colored coating material or the color of the anvil surface of the anvil head 32, this provides an indication to a clinician that the ends 80a and 80b of the first and second vessel sections 80 and 82 were clamped in sub-optimal fashion and the there is a probability that the anastomotic donut 98 (
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 aspects of the disclosure. 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 aspects of the disclosure. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.
This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63/159,529, filed Mar. 11, 2021, the entire contents of which is incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 63159529 | Mar 2021 | US |
