Patent Publication Number: US-2010127041-A1

Title: Surgical Stapling Instruments Structured for Delivery of Medical Agents

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of and claims priority to U.S. Ser. No. 11/267,811 filed on Nov. 4, 2005. 
    
    
     FIELD OF THE INVENTION 
     The present invention generally relates to surgical instruments. The invention more particularly relates to delivery and application of medical agents in association with the use of surgical instruments to promote closure and healing of severed and stapled tissue. 
     BACKGROUND 
     Conventional surgical staplers that can be used to simultaneously make longitudinal incisions in tissue and apply lines of staples on opposing sides of the incisions are known in the art. Such instruments commonly include a pair of cooperating jaw members that, when employed in endoscopic or laparoscopic applications, are capable of passing through a cannula passageway. One of the jaw members typically receives a staple cartridge having at least two laterally spaced rows of staples. The other jaw member defines an anvil having staple-forming pockets correspondingly aligned with the rows of staples in the cartridge. Such stapling instruments may also include a plurality of reciprocating wedges that pass through openings in the staple cartridge when driven and engage drivers supporting the staples to effect the firing of the staples toward the anvil and through tissue. 
     Examples of surgical staplers suitable for use with endoscopic applications are described in U.S. Patent Application No. US 2004/0232196 A1. In operation of the surgical stapler, a clinician closes or clamps the jaw members of the stapler on tissue to position the tissue prior to firing or activation of the stapler. Once the clinician has determined that the jaw members are clamping the tissue in a desired position, then the surgical stapler can be fired by the clinician to create an incision in the tissue and at the same time staple tissue surrounding the incision. This simultaneous action of the stapler avoids complications that often arise when the severing and stapling operations are performed sequentially (or at different times) with different surgical tools (i.e., one device is used to sever the tissue, and then another device is used to staple the tissue). 
     In general, application of certain medical agents to tissue incisions can promote healing, reduce the possibility of infection, and/or promote proper sealing of the incisions. If assisted by the action of such medical agents, many surgical staplers could achieve better surgical results with respect to enhanced healing, improved infection resistance, and improved sealing of tissue incisions. However, the structure of many conventional surgical staplers, and the procedures in which such staplers are employed, do not leverage the benefits of medical agents or systems that dispense medical agents. 
     In view of the foregoing, there is a need for improved surgical instruments and medical agent dispensing systems than can more effectively and efficiently promote closure, treatment, and healing of tissue incisions severed and stapled during operations involving surgical staplers. 
     SUMMARY 
     In accordance with the present invention, various embodiments of a medical agent dispensing system can be provided. The medical agent dispensing system may be structured for use with a surgical severing/stapling instrument structured for severing and stapling tissue. The dispensing system may include: at least one storage reservoir structured for storing at least a component of a medical agent; a gear pump casing in communication with the storage reservoir; a screw pump auger positioned within the gear pump casing capable of rotational manipulation to move the medical agent through the gear pump casing; and, at least one agent tube in communication with the gear pump casing. The agent tube may be structured for communication with a least one agent port formed in a staple cartridge of the surgical instrument for dispensing the medical agent therethrough. 
     In accordance with the invention, various embodiments of a surgical severing/stapling instrument including a medical agent dispensing system can be provided. The surgical instrument may include a handle portion including at least one storage reservoir structured for storing at least a component of a medical agent, and a shaft portion connected to the handle portion. The shaft portion may include a gear pump casing in communication with the storage reservoir, wherein the gear pump casing includes a screw pump auger extending therethrough capable of rotational manipulation to move the medical agent through the gear pump casing. The surgical instrument may also include an end effector portion operatively associated with the shaft portion that has a staple cartridge positioned removably therein. At least one agent tube may be provided in communication with the gear pump casing; and the agent tube may extend from the shaft portion to communicate with a least one agent port formed in the staple cartridge of the surgical instrument. The agent port may be structured to permit the medical agent to be dispensed therethrough. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       The accompanying drawings, which are incorporated into and constitute a part of this specification, illustrate embodiments of the invention. Together with the description of the embodiments provided herein, the drawings serve to explain the principles of the present invention for those skilled in the art. 
         FIG. 1  depicts an three-dimensional, partially cut-away, partially schematic view of a surgical instrument that may be provided in association with embodiments of a medical agent dispensing system in accordance with the present invention; 
         FIG. 2  illustrates a disassembled, three-dimensional view of the end effector and a shaft portion of the surgical instrument of  FIG. 1 ; 
         FIG. 3  includes schematic depictions of handle, shaft and end effector portions of the surgical instrument of  FIG. 1 ; 
         FIG. 4  includes an enlarged view of the shaft and end effector portions of the surgical instrument of  FIG. 3 ; 
         FIG. 5  includes a enlarged view of the shaft and handle portions of the surgical instrument of  FIG. 3 ; 
         FIG. 6  includes an enlarged, three-dimensional view of a screw pump auger that may be employed in accordance with various embodiments of the invention; 
         FIG. 7  includes an enlarged, partially cut-away, three-dimensional view of a portion of the instrument of  FIG. 1 ; 
         FIG. 8  includes an end view of the channel of the surgical instrument of  FIG. 2 ; and, 
         FIG. 9  includes a process flow diagram illustrating various aspects of an example of a method for using embodiments of the medical agent dispensing system of the present invention. 
     
    
    
     DESCRIPTION 
     As applied herein, the term “tissue” may include a variety of human or animal tissues, membranes, or other organic substrates. The term “tissue” may also include any substance, substrate, or composition of matter capable of being severed and stapled by the various embodiments of surgical stapling/severing instruments described herein. 
     As applied herein, the term “medical agent” may include a variety of chemicals, liquids, high viscosity fluids, powders or other compositions of matter that may be applied to tissues. Examples of “medical agents” include, without limitation, hemostatic agents, healing agents, adhesives, sealants, antibacterial agents, infection-resistant agents, analgesics, and various other kinds of medicinal or beneficial substances. 
     With general reference to the figures, and in association with various embodiments of the invention, a surgical severing/stapling instrument  10  may be structured with a handle portion  20  that is connected to an implement portion  22 . The implement portion  22  may include a shaft  24  which extends distally from the handle portion  20  and terminates in an end effector  26 . The end effector  26  may include an actuator or E-beam firing mechanism (“firing bar”)  28  that controls spacing between an elongated channel  30  and a pivotally translatable anvil  32  included within the end effector  26 . It can be seen that the spacing between the channel  30  and the anvil  32  may be configured to promote effective stapling and severing of tissue during use of the surgical instrument  10  by a clinician, for example. 
     The handle portion  20  of the instrument  10  may include a pistol grip  34  toward which a closure trigger  36  may be pivotally drawn by the clinician, for example, to cause clamping or closing of the anvil  32  toward the channel  30  of the end effector  26 . In operation, the tissue of a patient, for example, may be clamped by the closing of the anvil  32  toward the channel  30 . A firing trigger  38  positioned adjacent to the closure trigger  36  can be pivotally drawn in the direction of the pistol grip  34  to substantially simultaneously staple and sever tissue clamped in the end effector  26  of the instrument  10 . In a surgical operation, the clinician first activates the closure trigger  36  to clamp the tissue of a patient, for example. Once the clinician is satisfied with the positioning of the end effector  26 , the closure trigger  36  may be drawn back to a fully closed and locked position proximate to the pistol grip  34 . The firing trigger  38  of the instrument  10  may then be actuated to sever and staple the clamped tissue. The firing trigger  38  may springedly return to a normal, inactivated state when the clinician removes pressure applied to the firing trigger  38 . A release button  40  positioned on the proximal end of the handle portion  20  may be pressed by the clinician to release the locked closure trigger  36  to its normally open position (as shown in  FIG. 1 ). 
     In various embodiments, the distal end of the shaft  24  may include a closure tube  52  structured to receive and contain portions of the components of the end effector  26 , such as the anvil  32  and the channel  30 . The closure tube  52  may also be structured to receive a spine  54  extending therethrough that supports a knife shaft  56  having a distally positioned severing edge  58 . The knife shaft  56  may operatively interact with the firing bar  28  at the severing edge  58  of the knife shaft  56 . A knife spring  60  may be inserted within the spine  54  and structured with a resilient downward bias that promotes proper and secure positioning of the knife shaft  56  within the spine  54 . In operation, when the instrument  10  is fired, the knife shaft  56  and its severing edge  58  are moved through the channel  30  by a knife rod  61  to sever tissue clamped between the anvil  32  and the channel  30 . The channel  30  may be structured to receive a removable staple cartridge  62  therein. The staple cartridge  62  may have multiple staple holes (such as illustratively representative staple holes  64 ,  66 ,  68 ) formed therein and through which multiple staples (not shown) may be driven that staple severed tissue when the instrument  10  is fired. In certain embodiments, the staple cartridge  62  may be an “ETS45” or “ETS60” six-row cartridge, for example, marketed by Ethicon Endo-Surgery, Inc., of Cincinnati, Ohio. 
     Examples of the structure and operation of typical surgical stapling instruments that may be provided in association with embodiments of the present invention are disclosed in a United States published patent application to Shelton et al. entitled, “Surgical Stapling Instrument having Separate Distinct Closing and Firing Systems” (U.S. Pub. No. 2004/0232196, Ser. No. 10/441,632, filed on May 20, 2003), the entirety of which is hereby incorporated by reference. 
     With regard to embodiments of a medical agent dispensing system that may be provided in conjunction with the surgical instrument  10 , a gear pump casing  72  may be positioned to extend longitudinally through the spine  54 , and may extend from the handle portion  20  of the instrument  10  to a lateral manifold  74 . The gear pump casing  72  may be structured to receive therethrough a screw pump auger  76  that is capable of rotational manipulation when positioned within the gear pump casing  72 .  FIG. 6  shows an example of a screw pump auger  76  that may be used in accordance with various embodiments of the invention. One or more agent tubes  78 ,  80  may be positioned to communicate both with the lateral manifold  74  and with a plurality of agent ports (such as illustratively representative agent ports  82 ,  84 ,  86 ) formed in the staple cartridge  62  generally adjacent to the staple holes  64 ,  66 ,  68  of the cartridge  62 . The agent tubes  78 ,  80  may be structured for communication with the agent ports  82 ,  84 ,  86  in the staple cartridge  62  as shown in the end view of the cartridge  62  of  FIG. 8 . While a row of agent ports  82 ,  84 ,  86  is shown positioned next to both sides of a longitudinal center line of the channel  30 , it can be appreciated that more or less such agent ports  82 ,  84 ,  86  may be provided in the cartridge  62 . For example, more agent ports  82 ,  84 ,  86  may be provided in place of one or more of the staple holes  64 ,  66 ,  68  formed in the cartridge  62  as shown. With particular reference to  FIGS. 3 and 5 , one or more structures such as mounting blocks  79 ,  81  may be included within the channel  30  to facilitate securement and stability of the agent tubes  78 ,  80  (respectively) within the instrument  10 . Also, it can be seen that the agent tubes  78 ,  80  (such as the left-hand side agent tube  78 , as shown in  FIG. 4 , for example) may be positioned generally adjacent to the knife shaft  56  as the agent tubes  78 ,  80  extend longitudinally through the shaft  24 . 
     In various embodiments, the handle portion  20  may include one or more medical agent storage reservoirs  92 ,  94  mounted on the handle portion  20  and in communication with the casing  72 . The storage reservoirs  92 ,  94  may contain a variety of medical agents, or components thereof, that can be beneficially applied to severed and stapled tissue by action of the dispensing system in connection with use of the surgical instrument  10 . While multiple storage reservoirs  92 ,  94  are depicted with the instrument  10  for convenience of disclosure, certain embodiments of the invention may employ only a single storage reservoir or more than two storage reservoirs. It can be seen that employing multiple storage reservoirs  92 ,  94  can facilitate real-time mixing of multiple-component medical agents during operation of the medical agent dispensing system. For example, one storage reservoir  92  may contain a powder and the other storage reservoir  94  may contain a liquid. The powder and the liquid in the storage reservoirs  92 ,  94  may be mixed during operation of the instrument  10 , such as by directing the substances through the Y-manifold  96  (as shown in  FIGS. 3 and 5 , for example). It can be appreciated that storing and deploying components of a medical agent separately may preserve the shelf life and thus the effectiveness of the individual components. In another example, the use of multiple storage reservoirs  92 ,  94  permits the use of two-part adhesives, for example, in connection with operation of the dispensing system within the instrument  10 . 
     Also, in various embodiments of the medical agent dispensing system of the present invention, an electric motor  98  may be included within the handle portion  20  with a mechanical linkage structured to drive rotation of the screw pump auger  76  within the gear pump casing  72  upon activation of the motor  98 . Those skilled in the art will appreciate that the electric motor  98  may be any conventional battery-driven or AC-powered motor provided with specifications (e.g., a motor rating) suitable for safe and effective use of the motor  98  in association with operation of the surgical instrument  10 . In certain embodiments, the electric motor  98  may be activated through conventional electrical circuitry or components  100  that can be operatively associated with the firing trigger  38 , the release button  40 , and/or an independent manual activation switch  102  of the instrument  10 . The electrical circuitry  100  may be configured to activate the motor  98  automatically in association with the firing operation of the instrument  10 , for example; and/or to activate the motor  98  manually through use of the switch  102  which may be pressed by the clinician, for example, when using the instrument  10 . In certain embodiments, a mechanically driven rotary trigger, for example, may be configured to interact with the mechanical linkage operatively associated with the casing  72  to drive rotation of the screw pump auger  76  within the casing  72 . 
     With reference to  FIG. 9 , a process flow diagram illustrates a method of applying the instrument  10  with the medical agent dispensing system in a surgical procedure performed on tissue, in accordance with various embodiments of the invention. At step  202 , the instrument  10  may be fired as described above to sever tissue and to apply staples to areas on both sides of an incision made in the tissue. At step  204 , in connection with retraction of the knife shaft  56  from the severed/stapled tissue, the electric motor  98  may be activated to initiate rotation of the screw pump auger  76  within the gear pump casing  72  at step  206 . At step  208  (which may occur substantially in parallel with step  206 ), the gear pump casing  72  receives a quantity of a medical agent, or components combined to create a quantity of the medical agent, from the Y-manifold  96 . At step  210 , the medical agent is delivered by rotational action of the screw pump auger  76  to the lateral manifold  74 . At step  212 , the medical agent may be driven through the agent tubes  78 ,  80  to be dispensed at step  214  through the plurality of agent ports  82 ,  84 ,  86  in the staple cartridge  62 . Once dispensed through the plurality of agent ports  82 ,  84 ,  86 , the medical agent may then cover or deluge at least a portion of tissue areas severed and stapled by action of the instrument  10  at step  202 . 
     It will be appreciated that the terms “proximal” and “distal” may be used herein as convenient terms of relative orientation, such as with reference to a clinician gripping a handle of an instrument. For example, the end effector  26  may be considered “distal” with respect to the “proximal” handle portion  20  (see, e.g.,  FIG. 1 ). It will be further appreciated that, for convenience and clarity of disclosure, spatial terms of relative orientation such as “vertical” and “horizontal” or “downward” and “upward” may be used herein with respect to the drawings. Those skilled in the art will appreciate, however, that surgical instruments may be used in many orientations and positions, and such terms are not intended to be limiting and absolute. 
     Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is done so only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in the present disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material. 
     The examples presented herein are intended to illustrate potential and specific implementations of the present invention for those skilled in the art. No particular aspect or aspects of the examples included herein are necessarily intended to limit the scope of the present invention. 
     It is to be understood that the figures and descriptions of the present invention have been simplified to illustrate elements that are relevant for a clear understanding of the present invention, while eliminating, for purposes of clarity, other elements. Those of ordinary skill in the art will recognize, however, that these and other elements may be desirable in a typical computer system or database system. However, because such elements are well known in the art and because they do not facilitate a better understanding of the present invention, a discussion of such elements may not be provided herein. 
     Any element expressed herein as a means for performing a specified function is intended to encompass any way of performing that function including, for example, a combination of elements that perform that function. Furthermore the invention, as defined by such means-plus-function claims, resides in the fact that the functionalities provided by the various recited means are combined and brought together in a manner as defined by the appended claims. Therefore, any means that can provide such functionalities may be considered equivalents to the means shown herein. 
     In various embodiments of the present invention disclosed herein, a single component may be replaced by multiple components, and multiple components may be replaced by a single component, to perform a given function or functions. Except where such substitution would not be operative to practice embodiments of the present invention, such substitution is within the scope of the present invention. 
     While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art. The present invention has been discussed in terms of endoscopic procedures and apparatus. However, use herein of terms such as “endoscopic” should not be construed to limit the present invention to a surgical stapling and severing instrument for use only in conjunction with an endoscopic tube (i.e., trocar). On the contrary, it is believed that surgical instruments structured in accordance with the present invention may find use in many surgical procedures, including but not limited to laparoscopic procedures and open procedures. Moreover, the unique and novel aspects of the embodiments of the present invention may find utility when used in connection with other forms of stapling apparatuses without departing from the spirit and scope of the present invention.