Patent Publication Number: US-2022226627-A1

Title: Surgical stapling device with therapeutic suppository

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63/137,836, filed Jan. 15, 2021, the entire contents of which is incorporated by reference herein. 
    
    
     FIELD 
     This disclosure generally relates to a surgical stapling device and, more particularly, to a circular stapling device that includes a suppository to inhibit pathogens at an anastomotic site. 
     BACKGROUND 
     Circular stapling devices for performing surgical procedures such as anastomoses are well known. In an anastomosis procedure, two ends of organ sections are joined with the circular stapling device. Typically, circular stapling devices include a handle assembly, an elongated shaft or adapter assembly, a shell assembly including a staple cartridge, and an anvil assembly that is mountable to the adapter assembly in movable relation to the shell assembly. In use, opposed tissue end margins of the organ sections are clamped between an anvil head of the anvil assembly and the staple cartridge and the device is fired to drive an annular array of staples from the staple cartridge through the tissue end margins of the organ sections for deformation against the anvil head. An annular knife positioned within the shell assembly is advanced to core or remove organ tissue interior of the staples to clear an internal tubular passage of the organ sections. 
     Complications during anastomoses procedures may result in a need for further operation, permanent ostomy, and even death. One complication is anastomotic leakage. The risk of anastomotic leakage is multi-factorial and may be affected by patient comorbidities, chemotherapy, the presence of microbiome pathogens, and stapling technique. The presence of microbiomes increases the likelihood of anastomotic leakage. More particularly, microbiome pathogens including  Serratia marcescens  and  Pseudomonas aeruginosa  produce collagenase, an enzyme that breaks down peptide bonds of collagen which may prevent wound remodeling at the anastomotic site and result in anastomotic leakage. 
     A continuing need exists for a circular stapling device that can minimize the existence of microbiome pathogens at an anastomotic site. 
     SUMMARY 
     This disclosure is directed to a circular stapling device for performing anastomoses. The stapling device includes an end effector that supports one or more suppositories. 
     One aspect of the disclosure is directed to an end effector including an anvil assembly, a shell assembly, a first suppository, and a second suppository. The anvil assembly includes an anvil shaft and an anvil head. The anvil shaft has a proximal portion and a distal portion. The anvil head is supported on the distal portion of the anvil shaft and includes an annular staple forming surface. The shell assembly includes a shell housing and a staple cartridge. The staple cartridge is supported on the shell housing and includes an annular body and staples. The annular body defines staple slots and includes a tissue engaging surface. The staples are received within the staple slots. The first suppository is supported on the staple forming surface of the anvil head and includes an annular body having a therapeutic agent. The second suppository is supported on the tissue engaging surface of the annular body of the staple cartridge and includes the therapeutic agent. 
     Another aspect of the disclosure is directed to a circular stapling device including a handle assembly, an adapter assembly, and an end effector. The adapter assembly has a proximal portion coupled to the handle assembly and a distal portion including an anvil retainer. The end effector is supported on the distal portion of the adapter assembly and includes an anvil assembly, a shell assembly, a first suppository, and a second suppository. The anvil assembly includes an anvil shaft and an anvil head. The anvil shaft has a proximal portion coupled to the anvil retainer and a distal portion. The anvil head includes an annular staple forming surface. The shell assembly is supported on the distal portion of the adapter assembly and includes a shell housing and a staple cartridge. The staple cartridge is supported on the shell housing and includes an annular body and staples. The annular body defines staple slots and includes a tissue engaging surface. The staples are received within the staple slots. The first suppository is supported on the staple forming surface of the anvil head and has an annular body including a therapeutic agent. The second suppository is supported on the tissue engaging surface of the annular body of the staple cartridge and includes the therapeutic agent. 
     Another aspect of the disclosure is directed to a suppository that includes a waxy base and a therapeutic agent. The waxy base defines an annular body and is formed of a material that is solid at room temperature and melts at body temperature. The therapeutic agent is included in the waxy base. 
     In aspects of the disclosure, the first and second suppositories each include a waxy base having the therapeutic agent. 
     In some aspects of the disclosure, the first suppository is press-fit onto the staple forming surface of the anvil head of the anvil assembly, and the second suppository is press-fit onto the tissue engaging surface of the staple cartridge. 
     In certain aspects of the disclosure, the therapeutic agent is an antibiotic. 
     In aspects of the disclosure, the therapeutic agent is a polyphosphate. 
     In some aspects of the disclosure, the staple forming surface of the anvil head includes staple forming pockets. 
     In certain aspects of the disclosure, the first and second suppositories are formed of a material that is solid at room temperature and melts at body temperature. 
     In aspects of the disclosure, the waxy base of the first and second suppositories is formed from glycerin. 
     Other features of the disclosure will be appreciated from the following description. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Various aspects of a circular stapling device are described herein below with reference to the drawings, wherein: 
         FIG. 1  is a perspective view of a circular stapling device including a manually powered handle assembly according to aspects of the disclosure with the stapling device in an open position; 
         FIG. 2  is a perspective view of a circular stapling device including an electrically powered handle assembly according to aspects of the disclosure with the stapling device in an open position; 
         FIG. 3  is an enlarged view of the indicated area of detail shown in  FIG. 1 ; 
         FIG. 4  is an enlarged view of the indicated area of detail shown in  FIG. 2 ; 
         FIG. 5  is a side perspective view of an anvil assembly of the circular stapling devices shown in  FIGS. 1 and 2  with a suppository separated from the anvil assembly; 
         FIG. 6  is a perspective view of the distal portion of the circular stapling devices shown in  FIGS. 1 and 2  with an anvil assembly of the circular stapling devices removed and a suppository separated from a staple cartridge of the circular stapling device; 
         FIG. 7  is a view of a portion of a digestive system of a patient after a diseased portion of the colon of the digestive system is resected and two end portions of the resected colon are spaced from each other; 
         FIG. 8  is a side perspective view of the circular stapling device shown in  FIG. 1  positioned within the colon of a patient with the anvil assembly received within one end portion of the colon and a distal portion of the circular stapling device positioned in the other end portion of the colon with the circular stapling device in an open position; 
         FIG. 9  is a cross-sectional view taken along section line  9 - 9  of  FIG. 8 ; 
         FIG. 10  is a side perspective view of the circular stapling device shown in  FIG. 1  positioned within the colon of a patient with the anvil assembly received within one end portion of the colon and the distal portion of the circular stapling device positioned in the other end portion of the colon with the circular stapling device in a clamped position; 
         FIG. 11  is a side cross-sectional view taken through the anastomosed end portions of the colon shown in  FIG. 9  with the suppositories coupled to the end portion at the site of the anastomosis; and 
         FIG. 12  is a side cross-sectional view taken through the anastomosed end portions of the colon shown in  FIG. 9  at the site of the anastomosis after the suppositories have melted. 
     
    
    
     DETAILED DESCRIPTION 
     Aspects of the disclosure are now described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein, the term “clinician” refers to a doctor, a nurse, or any other care provider and may include support personnel. Throughout this description, the term “proximal” refers to that portion of the device or component thereof that is closest to the clinician during use of the device in its customary manner and the term “distal” refers to that portion of the device or component thereof that is farthest from the clinician. 
     This disclosure is directed to a circular stapling device that includes one or more suppositories that include a therapeutic agent. The suppositories are secured to an anastomotic site during an anastomotic procedure to minimize the level of bacterial collagenase at the anastomotic site and minimize the likelihood of anastomotic leakage. 
       FIG. 1  illustrates a circular stapling device  10  shown generally as stapling device  10  that includes a handle assembly  12 , an elongate body or adapter assembly  14  that extends from the handle assembly  12 , and an end effector  16  that is coupled to the adapter assembly  14 . The handle assembly  12  may be electrically powered and include a motor and associated gears and linkages to control operation of the stapling device  10 . The handle assembly  12  includes a stationary grip portion  18  and a plurality of actuation buttons  20  which may be activated to control various functions of the stapling device  10  including, e.g., approximation of the end effector  16  and firing of staples. The stationary grip  18  may support a battery pack (not shown) which powers the handle assembly  12 . U.S. Pat. No. 10,327,779 discloses an exemplary powered circular stapling device. 
     It is also envisioned that the stapling device  10 ′ ( FIG. 2 ) can include a manually powered handle assembly  12 ′ having a stationary grip portion  18 ′, a firing trigger  20 ′, and an approximation knob  22 ′. U.S. Pat. No. 10,022,126 (“the &#39;126 patent”) discloses an exemplary manually actuated circular stapling device. 
       FIGS. 3-6  illustrate the end effector  16  of the stapling devices  10  and  10 ′ which includes an anvil assembly  30  and a shell assembly  32 . The anvil assembly  30  includes an anvil shaft  34  and an anvil head  36 . The anvil shaft  34  includes a proximal portion  38  and a distal portion  40 . The distal portion  40  supports the anvil head  36 . In aspects of the disclosure, the anvil head  30  is pivotably coupled to the anvil shaft  34  and is movable from an operative position ( FIG. 5 ) to a pivoted or tilted position (not shown). In the tilted position, the profile of the anvil head  36  is minimized to facilitate insertion and/or removal of the anvil assembly  30  to and from an organ section “OS”. ( FIG. 7 ). The proximal portion  38  of the anvil shaft  34  is adapted to releasably engage an anvil retainer  42  ( FIG. 6 ) of the stapling device  10  ( FIG. 1 ). In aspects of the disclosure, the proximal portion  38  of the anvil shaft  34  includes resilient fingers  44  that define a longitudinal bore  46  ( FIG. 5 ) that receive the anvil retainer  42  ( FIG. 6 ) of the stapling device  10  to couple the anvil assembly  30  to the anvil retainer  42 . For a detailed description of an anvil shaft and anvil retainer suitable for use with the stapling device  10 , see the &#39;126 patent. 
     The anvil head  36  of the anvil assembly  30  includes an annular staple forming surface  50  ( FIG. 5 ) that defines a plurality of staple forming pockets  52 . In aspects of the disclosure, the staple forming pockets  52  are formed in annular rows about the staple forming surface  50 . The staple forming surface  50  supports an annular suppository  54 . In aspects of the disclosure, the annular suppository  54  is formed of a material having a waxy base, e.g., glycerin or similar material, that includes a therapeutic agent, e.g., an antibiotic or polyphosphate. In aspects of the disclosure, the waxy base is formed of a material that is solid at room temperature and melts at body temperature such that when secured within an organ section “OS” ( FIG. 7 ) of a patient, the waxy base melts to deliver the therapeutic agent to the tissue within the organ section “OS”. In aspects of the disclosure, the annular suppository  54  is press-fit onto the staple forming surface  50  of the anvil head  36  of the anvil assembly  30 . Alternately, it is envisioned that the annular suppository  54  can be secured to the staple forming surface  50  of the anvil head  36  of the anvil assembly  30  using other known techniques or devices including adhesives. 
     The shell assembly  32  includes a shell housing  60  that supports a staple cartridge  62 . The staple cartridge  62  is supported within a distal portion of the shell housing  60  and includes an annular body  64  that defines staple slots  66  ( FIG. 6 ) and includes a tissue contact surface  68  ( FIG. 6 ). Each of the staple slots  66  receives a staple  70  ( FIG. 11 ). In aspects of the disclosure, the staple slots  66  are arranged in annular rows that are positioned about the annular body  64  of the staple cartridge  62 . When the stapling device  10  is approximated by retracting the anvil retainer  42  ( FIG. 6 ) into the shell assembly  32 , the staple forming surface  50  of the anvil head  36  is moved into juxtaposed alignment with the tissue contact surface  68  of the staple cartridge  62  to a clamped position. In the clamped position, the staple slots  66  of the staple cartridge  62  are aligned with the staple forming pockets  52  of the anvil head  36 . 
     The staple cartridge  62  of the shell assembly  32  supports an annular suppository  72 . In aspects of the disclosure, the annular suppository  72  is like the annular suppository  54  and is formed of a material having a waxy base, e.g., glycerin or similar material, that includes a therapeutic agent, e.g., an antibiotic or polyphosphate. In aspects of the disclosure, the waxy base is formed of a material that is solid at room temperature and melts at body temperature such that when secured within an organ section “OS” ( FIG. 7 ) of a patient, the waxy base melts to deliver the therapeutic agent to the tissue within the organ section “OS”. In aspects of the disclosure, the annular suppository  72  is press-fit onto the tissue contact surface  68  of the staple cartridge  50  of the shell assembly  32 . Alternately, it is envisioned that the annular suppository  72  can be secured to the tissue contact surface  68  of the staple cartridge  50  of the shell assembly  32  using other known techniques or devices including adhesives. 
       FIG. 7  illustrates a portion of a digestive system “DS” of a patient in which a portion “RP” of a colon “C” of the digestive system “DS” has been resected such that end portions  80  and  82  of the colon “C” to be anastomosed are positioned in spaced relation to each other. 
       FIGS. 8-11  illustrate an anastomosis procedure using the stapling device  10 . During the anastomosis procedure, the anvil head  36  of the anvil assembly  30  is positioned within the end portion  80  of the colon “C” and a purse-string suture  90  is applied to the end portion  80  to secure the end portion  80  about the anvil shaft  34 . Next, the shell assembly  32  of the stapling device  10  is positioned within the end portion  82  of the colon “C” and the anvil assembly  30  is coupled to the anvil retainer  42  of the stapling device  10 . The end portion  82  of the colon “C” is secured about the anvil retainer  42  using a second purse string suture  92  ( FIG. 9 ). Once the end portions  80  and  82  of the colon “C” are secured to the anvil shaft  34  and the anvil retainer  42 , respectively, the stapling device  10  is approximated by retracting the anvil retainer  42  into the shell assembly  32  to move the anvil head  36  of the anvil assembly  30  into juxtaposed opposition with the staple cartridge  62  of the shell assembly  32  to clamp the end portions  80  and  82  between the anvil head  36  and the staple cartridge  62  ( FIG. 10 ). 
     Once the end portions  80  and  82  of the colon “C” are clamped between the anvil head  36  and the staple cartridge  62 , the stapling device  10  can be fired to eject the staples  70  from the staple cartridge  62  through the suppositories  54  and  72  and through the end portions  80  and  82  of the colon “C” to join the end portions  80  and  82  together ( FIG. 11 ) and secure the suppositories  54  and  72  to the end portions  80  and  82  of the colon “C”. As shown in  FIG. 11 , when the staples  70  are fired into the suppositories, the staples  70  move through the suppositories  54  and  72  to hold the end portions  80  and  82  tightly together. 
     When the suppositories  54  and  72  enter the patient&#39;s body, the suppositories  54  and  72  begin to melt and the therapeutic agent within the suppositories  54  and  72  is eluted and absorbed into the mucosa within the anastomosed colon “C” ( FIG. 11 ). Eventually, the suppositories  54  and  72  will melt completely such that only the staples  70  remain at the site of the anastomosis ( FIG. 12 ). The therapeutic agent, e.g., antibiotic, delivered to the location of the anastomotic site will combat pathogen bacteria to minimize the level of bacterial collagenase and minimize the likelihood of anastomotic leakage. 
     Although the circular stapling device  10  is described to include a suppository on both the anvil assembly and the shell assembly, it is envisioned that only one suppository may be provided on one or the other of the anvil and shell assemblies. 
     Persons skilled in the art will understand that the instruments 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 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.