US20120029272A1 - Apparatus and methods for protecting adjacent structures during the insertion of a surgical instrument into a tubular organ - Google Patents

Abstract

A device for protecting tissues and structures adjacent to a tubular organ during performance of a surgical procedure on a portion of the tubular organ. Various embodiments may comprise a member that may be deployed through a surgical instrument in a first configuration and expanded to a second configuration such that when in the second configuration, the protective member may extend substantially around an outer circumference of the portion of the tubular organ.

Description

FIELD OF THE INVENTION
• The present invention generally relates to surgical staplers, and more particularly, to devices and methods for holding and/or protecting tissue adjacent to the stapler head of a circular stapler.
BACKGROUND
• In certain types of surgical procedures, the use of surgical staples has become the preferred method of joining tissue and, as such, specially configured surgical staplers have been developed for these applications. For example, intra-luminal or circular staplers have been developed for use in surgical procedures involving the lower colon wherein sections of the lower colon are joined together after a diseased portion has been excised. Circular staplers useful for performing such procedures are disclosed, for example, in U.S. Pat. Nos. 5,104,025; 5,205,459; 5,285,945; and 5,309,927 which are each herein incorporated by reference in their respective entireties.
• In general, a conventional circular stapler typically consists of an elongated shaft that has a proximal actuating mechanism and a distal stapler head mounted to the elongated shaft. The distal stapler head commonly consists of a fixed stapling cartridge that contains a plurality of staples configured in a concentric circular array. A round cutting knife is concentrically mounted in the cartridge interior to the staples for axial travel therein. Extending axially from the center of the cartridge is a movable trocar shaft that is adapted to have a staple anvil removably coupled thereto. The anvil is configured to form the ends of the staples as they are driven into it. The distance between a distal face of the staple cartridge and the staple anvil is commonly controlled by an adjustment mechanism that is mounted to the proximal end of the stapler shaft for controlling the axial movement of the trocar. Tissue that is clamped between the staple cartridge and the staple anvil is simultaneously stapled and cut when the actuating mechanism is activated by the surgeon.
• When performing a lower colon procedure using a circular stapler, a portion of the intestine may be laproscopically stapled using a conventional surgical stapler that is inserted through a trocar. The conventional surgical stapler serves to place multiple rows of staples on either side of the diseased portion of colon to be removed. The target or diseased section is simultaneously cut as the adjoining end of the colon is stapled. After removing the diseased portion, the surgeon typically inserts the anvil of the circular stapling instrument into the distal end of the lumen, distal of the staple line. This may be done by inserting the anvil head into an entry port cut into the distal lumen by the surgeon. The lower staple line is utilized to hold the tissue of the colon over the circular cartridge. This method seals both ends of the colon only to have the sealed portions cut through and removed. These intermediate step staple lines are only temporary and facilitate the next step in the procedure.
• On occasion, the anvil can be placed transanally, by placing the anvil head on the distal end of the stapler and inserting the instrument through the rectum. Once the anvil has been installed in the distal portion of the intestine, the intestine is secured around the anvil shaft by what is known as a “purse string” suture. The proximal portion of intestine is similarly secured around the stapler head by a purse string suture.
• Once the ends of the intestine have been secured around their respective components, the surgeon, through an appropriate trocar sleeve, may employ a grasping device to grasp the anvil shaft and attach it to the portion of the trocar protruding within the stapler head. The surgeon then closes the gap between the anvil and cartridge, thereby clamping the proximal and distal ends of the intestine in the gap. The surgeon next actuates the stapler causing several rows of staples to be driven through both ends of the intestine and formed, thereby joining the ends and forming a tubular pathway. Simultaneously, as the staples are driven and formed, the concentric annular knife blade is driven through the intestinal tissue ends, cutting the ends adjacent to the inner row of staples. The surgeon then withdraws the stapler from the intestine and the procedure is complete.
• Such procedures and devices require the surgeon to install two purse string sutures which lengthens the time required to complete the surgical procedure. In addition, such procedures may at times cause tissue “bunching” during the tissue cutting/stapling process.
• Various attempts have been made to retain colon and other tissues around the stapling device. For example, U.S. Pat. Nos. 5,309,927; 6,117,148; and 7,094,247 disclose various arrangements that, in general, employ fasteners, ligation members, rings, springs, etc. that are apart from the stapling device itself in an effort to retain the tissue in position. U.S. Pat. No. 5,669,918 discloses a mechanism that employs a grasper like arm to frictionally pin the tissue against the trocar shank. While such device is essentially self contained, the grasper arms may ultimately be unable to effectively retain the tissue in position in practice.
• Thus, the need exists for devices and methods for reducing the time required to complete the surgical procedure as well as addressing other shortcomings and challenges associated with retaining tissue in position when employing circular stapler arrangements.
• The foregoing discussion is intended only to illustrate some of the shortcomings present in the field of the invention at the time, and should not be taken as a disavowal of claim scope.
BRIEF SUMMARY
• In accordance with a general aspect of various non-limiting embodiments of the present invention, there is provided a surgical instrument comprising a protective member for protecting tissues and structures adjacent to a tubular organ during performance of a surgical procedure on a portion of the tubular organ. In various embodiments, the protective member comprises a member that may be deployed through a surgical instrument in a first configuration and expanded to a second configuration such that when in the second configuration, the protective member may extend substantially around an outer circumference of the portion of the tubular organ.
• In accordance with another general aspect of various embodiments of the present invention, there is provided a procedure for protecting tissues and structures adjacent to a tubular organ within an abdominal cavity during the manipulation and operation of surgical instruments within a target portion of the tubular organ. Various embodiments comprise introducing a protective sheath into the abdominal cavity adjacent to the target portion and surrounding the target portion of the tubular organ with the protective sheath. The procedure further comprises retaining the protective sheath in position surrounding the target portion.
• In accordance with yet another general aspect of the present invention, there is provided a surgical procedure for treating a target portion of a patient's colon. In various embodiments, the procedure includes inserting a hollow cannula of a trocar through an abdominal wall into an abdominal cavity adjacent to a target portion of the colon. The procedure further includes coiling a protective sheath, passing the coiled sheath through the hollow cannula into the abdominal cavity and uncoiling the sheath. The procedure further comprises positioning the uncoiled sheath around the target portion of the colon such that a natural coiling tendency of the protective sheath retains the protective sheath in a position around an outer circumference of the target portion of the colon.
BRIEF DESCRIPTION OF THE FIGURES
• The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.
• FIG. 1 is a perspective view of a surgical circular stapling instrument of various non-limiting embodiments of the present invention;
• FIG. 1A is a cross-sectional view of the handle portion of various embodiments of the surgical stapling instrument of the present invention;
• FIG. 2 is a cross-sectional view of a distal end portion of the elongated shaft of the circular stapling instrument ofFIG. 1;
• FIG. 2A is a partial cross-sectional view of the distal end of the elongated shaft with an anvil coupled thereto;
• FIG. 2B is a partial cross-sectional view of the distal end of the elongated shaft taken alongline2B-2B inFIG. 2A;
• FIG. 2C is a cross-sectional view of a portion of the handle assembly of an embodiment of the present invention;
• FIG. 2D is a cross-sectional view of another portion of the elongated shaft of various embodiments of the present invention;
• FIG. 3 is an end view of the elongated shaft ofFIG. 2;
• FIG. 4 is a partial perspective view of the distal end portion of the elongated shaft ofFIGS. 2 and 3 with the tissue acquisition members and the knife members thereof in their radially deployed positions;
• FIG. 5 is a partial cross-sectional view of the distal end of the elongated shaft with an anvil coupled thereto and inserted into a portion of a patient's tubular organ such as a colon;
• FIG. 6 is another cross-sectional view of the distal end of the elongated shaft ofFIG. 5 with the anvil removed therefrom;
• FIG. 7 is another cross-sectional view of the distal end of the elongated shaft ofFIGS. 5 and 6 with the distal end portion of the cutter housing being axially advanced beyond the distal face of the staple cartridge supported in the distal end of the elongated shaft;
• FIG. 8 is another cross-sectional view of the distal end of the elongated shaft ofFIG. 7 with tissue acquisition members being radially deployed out of the tissue acquisition housing and piercing through a portion of the colon;
• FIG. 9 is another cross-sectional view of the distal end of the elongated shaft ofFIG. 8 with the tissue acquisition members thereof being withdrawn back into the tissue acquisition housing to position the punctured portion of the colon adjacent to the distal face of the staple cartridge;
• FIG. 10 is another cross-sectional view of the distal end of the elongated shaft ofFIG. 9 with the knife members radially deployed out of the cutter housing and puncturing through another portion of the colon;
• FIG. 11 is another cross-sectional view of the distal end of the elongated shaft ofFIG. 10 after the knife members have been rotated to sever the retained punctured portion of colon from a diseased portion of the colon;
• FIG. 12 is another cross-sectional view of the distal end of the elongated shaft ofFIG. 11 with the knife members withdrawn back into their respective lumens in the cutter housing;
• FIG. 13 is another cross-sectional view of the distal end of the elongated shaft ofFIG. 12 after an anvil has been secured to a distal portion of the colon and the anvil stem thereof has been coupled to the anvil assembly portion of the circular stapling instrument;
• FIG. 14 is another cross-sectional view of the distal end of the elongated shaft ofFIG. 13 after the anvil has been drawn adjacent to the distal face of the staple cartridge;
• FIG. 15 is another cross-sectional view of the distal end of the elongated shaft ofFIG. 14 after the staples have been deployed and annular knife has been axially advanced through the adjacent portions of colon;
• FIG. 16 is another cross-sectional view of the distal end of the elongated shaft ofFIG. 15 after the colon sections have been stapled together, but prior to being withdrawn from the colon;
• FIG. 17 is a perspective view of a surgical circular stapling instrument of various non-limiting embodiments of the present invention;
• FIG. 18 is a cross-sectional view of a distal end portion of the elongated shaft of the circular stapling instrument ofFIG. 17;
• FIG. 19 is an exploded assembly view of the acquisition and deployment shafts of various non-limiting embodiments of the present invention;
• FIG. 20 is a partial perspective view of the acquisition shaft ofFIG. 19 with the tissue arms thereof in a retracted position;
• FIG. 21 is a partial cross-sectional view of the acquisition shaft ofFIGS. 19 and 20, with the tissue arms thereof in a deployed position;
• FIG. 22 is a perspective view of the acquisition shaft ofFIG. 21;
• FIG. 23 is a cross-sectional view of the elongated shaft of various non-limiting embodiments of the present invention, with an anvil attached thereto and inserted into a portion of a patient's colon;
• FIG. 24 is another cross-sectional view of the elongated shaft ofFIG. 23, with the anvil removed and the acquisition arms deployed through a proximal portion of the colon that is adjacent to a target or diseased portion of the colon;
• FIG. 25 is a top cross-sectional view of the elongated shaft ofFIG. 24 taken along line25-25 inFIG. 24 with the tissue acquisition arms extended through the proximal portion of the colon;
• FIG. 26 is a partial cross-sectional view of the elongated shaft ofFIGS. 24 and 25 with the targeted or diseased portion of the colon being removed with a grasping instrument;
• FIG. 27 is a top cross-sectional view of the elongated shaft ofFIG. 26 taken along line27-27 inFIG. 26;
• FIG. 28 is a partial cross-sectional view of the elongated shaft after the anvil has been inserted into a distal portion of the colon and secured thereto by a purse-string suture arrangement;
• FIG. 29 is a cross-sectional view of the elongated shaft ofFIG. 28 after the anvil has been coupled to the anvil assembly thereof and drawn into confronting relationship with the stapling cartridge therein;
• FIG. 30 is a cross-sectional view of the elongated shaft ofFIG. 29 after the staple cartridge had been fired and the annular cutting member advanced through the stapled tissue portions;
• FIG. 31 is a cross-sectional view of the elongated shaft ofFIG. 30 being withdrawn from the colon after completion of the stapling procedure;
• FIG. 32 is a perspective view of another a surgical circular stapling instrument of various non-limiting embodiments of the present invention;
• FIG. 33 is a cross-sectional view of a distal end portion of the elongated shaft of the circular stapling instrument ofFIG. 32;
• FIG. 34 is a partial perspective view of a hook and detection housing portion of the elongated shaft ofFIG. 33 with the detection members thereof in a retracted position;
• FIG. 35 is another partial perspective view of the hook and detection housing ofFIG. 34 with the detection members thereof in a deployed orientation;
• FIG. 36 is a partial cross-sectional view of the distal end of the elongated shaft with the detection members thereof in a deployed orientation within a colon;
• FIG. 37 is a top cross-sectional view of the elongated shaft and colon ofFIG. 36 taken along line37-37 inFIG. 36;
• FIG. 38 is a perspective view of another circular stapling instrument of various non-limiting embodiments of the present invention;
• FIG. 39 is a cross-sectional view of a distal end portion of the elongated shaft of the circular stapling instrument ofFIG. 38 inserted into the proximal portion of a tubular organ such as a colon;
• FIG. 40 is an exploded assembly view of distal end portions of a tissue acquisition shaft, a deployment shaft and a knife shaft of various non-limiting embodiments of the present invention;
• FIG. 41 is a partial perspective view of the tissue acquisition shaft ofFIG. 40 with the tissue arms thereof in a retracted position;
• FIG. 42 is a perspective view of the acquisition shaft ofFIG. 41 with the tissue arms thereof in deployed positions;
• FIG. 43 is a partial cross-sectional view of a distal end portion of the elongated shaft of the surgical instrument ofFIG. 38 inserted into a proximal portion of the colon with the anvil assembly removed therefrom;
• FIG. 44 is a partial cross-sectional view of the distal end portion of the elongated shaft with the tissue acquisition arms deployed through a proximal portion of the colon;
• FIG. 45 is a top cross-sectional view of the distal end portion of the elongated shaft take along line45-45 inFIG. 44;
• FIG. 46 is another partial cross-sectional view of the distal end portion of the elongated shaft after the tissue acquisition arms have been deployed through the proximal portion of the colon and then moved to a retracted position wherein the pierced proximal portion is trapped between the tissue acquisition arms and the tissue acquisition shaft;
• FIG. 47 is a top cross-sectional view of the distal end portion of the elongated shaft ofFIG. 46 taken along line47-47 inFIG. 46;
• FIG. 48 is a partial cross-sectional view of the distal end portion of the elongated shaft with the diseased portion of the colon being severed from the proximal portion and distal portion and being removed from the colon by conventional graspers;
• FIG. 49 is a partial cross-sectional view of the elongated shaft after the anvil has been inserted into a distal portion of the colon and secured thereto by a purse-string suture arrangement;
• FIG. 50 is a cross-sectional view of the elongated shaft ofFIG. 49 after the anvil has been coupled to the anvil assembly thereof and drawn into confronting relationship with the staple cartridge therein;
• FIG. 51 is a cross-sectional view of the elongated shaft ofFIG. 50 after the staple cartridge had been fired and the annular cutting member advanced through the stapled tissue portions;
• FIG. 52 is a cross-sectional view of the elongated shaft ofFIG. 51 being withdrawn from the colon after completion of the stapling procedure;
• FIG. 53 is a view of a portion of a patient's opened abdominal cavity illustrating various tissues and structures adjacent a portion of the colon;
• FIG. 54 is another partial view of the open abdominal cavity ofFIG. 53;
• FIG. 55 is another view of the abdominal cavity ofFIG. 53 illustrating the insertion of a trocar into the abdominal cavity to deliver a protective sheath embodiment of the present invention therein;
• FIG. 56 is another view of the abdominal cavity ofFIG. 55 with the protective sheath embodiment being withdrawn from the trocar sleeve by a conventional grasping device;
• FIG. 57 is another view of the abdominal cavity ofFIG. 56 illustrating one method of positioning the protective sheath around the circumference of a portion of the colon to be treated; and
• FIG. 58 is another view of the abdominal cavity ofFIG. 57 after the protective sheath embodiment has been positioned around the outer circumference of the portion of colon to be treated.
DETAILED DESCRIPTION
• The Applicant of the present application also owns the U.S. patent applications identified below which were filed on even date herewith and which are each herein incorporated by reference in their respective entirety:
• U.S. patent application Ser. No. ______, entitled “Surgical Circular Stapler With Tissue Retention Arrangements”, Attorney Docket No. END6741USNP/100065;
• U.S. patent application Ser. No. ______, entitled “Tissue Acquisition Arrangements and Methods For Surgical Stapling Devices”, Attorney Docket No. END6739USNP/100063;
• U.S. patent application Ser. No. ______, entitled “Transwall Visualization Arrangements and Methods For Surgical Circular Staplers”, Attorney Docket No. END6738USNP/100062; and
• U.S. patent application Ser. No. ______, entitled “Circular Stapling Instruments With Secondary Cutting Arrangements and Methods of Using Same”, Attorney Docket No. END6740USNP/100064.
• Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the various embodiments of the present invention is defined solely by the claims.
• Reference throughout the specification to “various embodiments,” “some embodiments,” “one embodiment,” or “an embodiment”, or the like, means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in various embodiments,” “in some embodiments,” “in one embodiment”, or “in an embodiment”, or the like, in places throughout the specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features structures, or characteristics of one or more other embodiments without limitation. Such modifications and variations are intended to be included within the scope of the present invention.
• The terms “proximal” and “distal” are used herein with reference to a clinician manipulating the handle portion of the surgical instrument. The term “proximal” referring to the portion closest to the clinician and the term “distal” referring to the portion located away from the clinician. It will be further appreciated that, for convenience and clarity, spatial terms such as “vertical”, “horizontal”, “up”, and “down” may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.
• FIG. 1 illustrates acircular stapler10 according to various non-limiting embodiments of the invention. In various embodiments, thecircular stapler10 includes ahandle assembly12 that has an elongatedshaft assembly14 protruding therefrom that defines a central axis A-A. Theelongate shaft assembly14 includes a rigidouter sheath16 that has adistal end portion17 that forms astapler head20. In various non-limiting embodiments, thestapler head20 is configured to operably support acircular staple cartridge30 therein. Suchcircular staple cartridges30 are known in the art and may generally support one, two, or more circumferentially spaced and staggered rows ofstaples36 therein. SeeFIGS. 2 and 3. The embodiment depicted inFIG. 3, for example, has tworows32,34, ofstaples36. A conventionalannular knife40 is coaxially and movably supported within thestapler head20.
• In certain implementations, thecircular stapler10 further includes a firingshaft assembly50 that is supported within theouter sheath16 for selective axial travel therein. SeeFIG. 2. Adistal end portion52 of the firingshaft assembly50 has an outerstaple driver portion54 thereon for engagement with each of thestaples36 in theouter row32 ofstaples36 in thestaple cartridge30. In addition, thedistal end portion52 of the firingshaft assembly50 has an innerstaple driver portion56 that is configured for engagement with each of thestaples36 in theinner row34 ofstaples36 within thestaple cartridge30. As can also be seen inFIG. 2, for example, thedistal end portion52 of the firingshaft assembly50 further has aledge58 that is configured to engage theannular knife40. Thus, as will be discussed in further detail below, axial advancement of the firingshaft assembly50 in a distal direction “DD”, will cause thestaples36 to be driven out of thestaple cartridge30 as well as theannular knife40 to be advanced distally. As can be seen inFIG. 2A, the firingshaft assembly50 has abase portion51 that is coupled to a firingrod53.
• In various non-limiting embodiments, the firingrod53 operably interfaces with a firingtrigger60 that is operably coupled to thehandle assembly12. SeeFIGS. 1 and 1A. As can be seen inFIGS. 1 and 1A, the firingtrigger60 is pivotally coupled to thehandle assembly12 such that when the firingtrigger60 is pivoted toward thehandle assembly12, the firingshaft assembly50 is moved in the distal direction DD. Such firing trigger arrangements are known in the art and therefore will not be discussed in detail herein. For example, an exemplary firing trigger arrangement is disclosed in U.S. Patent Application Publication No. US 2008/0078806 A1, entitled “Surgical Stapling Instrument With Mechanical Indicator to Show Levels of Tissue Compression”, the disclosure of which is herein incorporated by reference in its entirety.
• As shown inFIGS. 2 and 2A, various non-limiting embodiments include anacquisition housing70 that is coaxially supported within the firingshaft assembly50 and is axially movable relative thereto. Theacquisition housing70 has a plurality ofacquisition lumens72 therein that each movably support an acquisition orhook member80. As can be seen inFIG. 3, for example, the plurality of three-sided acquisition lumens72 may be equally spaced around the circumference of theacquisition housing70. In the non-limiting embodiment depicted inFIG. 3, a total of eight (8)acquisition lumens72 are equally spaced around the circumference of theacquisition housing70.
• Each acquisition orhook member80 may be fabricated from, for example, Nitinol, 300 or 400 series stainless steel (fully or three-fourths hardened) and have adistal end portion82 that, when advanced out of itsrespective acquisition lumen72, bends radially outward as shown inFIG. 4. As can also be seen inFIG. 4, eachhook member80 has atissue barb84 formed on thedistal end portion82 thereof. As can be seen inFIGS. 2 and 3, in various non-limiting embodiments, asleeve78 is employed to facilitate installation of thehook members80 into theirrespective lumens72.
• As can be seen inFIG. 2A, each of thehook members80 are coupled to or protrude from anacquisition ring81 that has a pair ofacquisition rods83 attached thereto. Theacquisition rods83 are attached to ahook switch90 that is operably supported on thehandle assembly12. SeeFIGS. 1 and 2C. As the surgeon moves thehook switch90 in a distal direction (arrow92 inFIGS. 1 and 2C), theacquisition housing70 moves distally. Such movement of theacquisition housing70 causes thedistal end portion84 of eachhook member80 to be advanced distally out of itsrespective acquisition lumen72. As thedistal end portion84 of eachhook member80 is advanced out of theacquisition lumen72, the natural bending action of thehook member80 causes theend portion84 to bend radially away from the central axis A-A as illustrated inFIG. 4. The surgeon may retract theacquisition housing70 and thehook members80 into their starting positions (FIG. 2), by moving thehook switch90 in a proximal direction (arrow94 inFIGS. 1 and 2C).
• As can be further seen inFIGS. 2,2A,2D,3 and4, in various non-limiting embodiments, acutter housing100 is coaxially supported within theacquisition housing70. Thecutter housing100 is supported for selective axial travel relative to theacquisition housing70 and for selective axial travel along central axis A-A. In various embodiments, a pair ofhousing actuation rods101 protrude from thecutter housing100 to interface with aknife knob110 that is movably supported on thehandle assembly12. SeeFIGS. 1 and 2D. In various non-limiting embodiments, theknife knob110 is supported on thehandle assembly12 such that it can move axially (represented byarrows112,114 inFIGS. 1 and 2D) and also be rotated relative to the handle assembly12 (represented byarrow116 inFIG. 1). Thehousing actuator rods101 are attached to theknife knob110 such that movement of theknife knob110 in an axial direction moves thecutter housing100 axially within theacquisition housing70 and rotation of theknife knob110 also rotates thecutter housing100 about the central axis A-A as will be discussed in further detail below.
• In various non-limiting embodiments, thecutter housing100 includes at least one, and preferably a plurality of,knife lumens102 that extend axially through the wall of thecutter housing100. As can be seen inFIG. 3, for example, the plurality ofknife lumens102 may be spaced equally around the circumference of thecutter housing100. In the non-limiting embodiment depicted inFIG. 3, a total of eight (8)knife lumens102 are equally spaced around the circumference of thecutter housing100. As can be seen inFIGS. 2 and 4, eachknife lumen102 has a curveddistal end portion104 that opens radially outward.
• In various non-limiting embodiments, aflexible knife member120 is slidably received within eachknife lumen102. Eachflexible knife member120 has a sharpeneddistal end122 and is attached to or protrudes from aknife ring123. A pair ofknife actuator rods125 are attached to theknife ring123 by a slipjoint arrangement127 that permits theknife ring123 to rotate relative to theactuator rods125. SeeFIG. 2A. As can be seen inFIG. 2C, the knife actuator rods125 (only oneknife actuator rod125 is shown in that view) are attached to aknife switch130 that is operably mounted to thehandle12. Thedistal end122 of eachknife member120 is substantially pointed to enable it to pierce through tissue and it may have at least onecutting edge124 formed thereon. When theknife switch130 is moved in the distal direction (arrow132), theknife members120 are moved distally within theknife lumens102 such that the sharpeneddistal end122 “naturally” flexes or bends radially out of the curveddistal end portion104 of thelumen102 as shown inFIG. 4. As used in this context, the term “naturally” means that the material may be prestressed or otherwise formed such that the distal end thereof flexes or bends as it exits the lumen. Likewise, movement of theknife switch130 in the proximal direction (represented byarrow134 inFIGS. 1 and 2C) causes eachknife member120 to be retracted back into itsknife lumen102. In various non-limiting embodiments, theknife members120 may be fabricated from, for example, Nitinol, 300 or 400 series stainless steel (fully or three-fourths hardened).
• As can also be seen inFIG. 2A, the firingshaft assembly50 has adistal end post140 that protrudes from thebase portion51 and coaxially extends within thecutter housing100 for selective axial travel therein. Various embodiments also include abulkhead member141 that is mounted within theouter sheath116. To facilitate easy assembly, theouter sheath16 may comprise a distalouter sheath segment16 and a proximalouter sheath segment16′ as shown inFIG. 2A. In addition, adistal end post142 extends from thebulkhead51 and supports adistal anvil connector150. Thedistal anvil connector150 is coupled to adistal band assembly151. Thedistal band assembly151 is coupled to acontrol rod assembly153 that interfaces with anadjustment knob160 that is rotatably supported on thehandle assembly12. Such anvil shaft assemblies and control knob arrangements are generally known. For example, the control rod assembly and control knob may be configured as disclosed in published U.S. Patent Application No. US 2008/0078806 A1, entitled “Surgical Stapling Instrument With Mechanical Indicator To Show Levels of Tissue Compression, which has been herein incorporated by reference.
• As can be seen inFIG. 2B, each of thehousing actuator rods101 protrude through a correspondingarcuate slot145 in thebulkhead141. Theslots145 may be sized to define/limit the amount that thecutter housing100 may be rotated relative to the central axis A-A. For example, in one embodiment wherein a total of eight (8)knife members120 are employed, theslots145 may be sized to facilitate at least approximately 45°-50° of arcuate or rotational travel of thecutter housing100 about the central axis A-A. Thebulkhead141 may further have anaperture146 for permitting thedistal band assembly151 to protrude therethrough. In addition, each of theknife actuator rods125 extends through acorresponding opening147 in thebulkhead141. Similarly, each of theacquisition rods83 extend through acorresponding aperture148 in thebulkhead141. SeeFIG. 2B.
• Thecircular stapler10 further includes ananvil170 as shown inFIG. 5. In various non-limiting embodiments, theanvil170 includes ananvil base171 that has a series ofstaple forming pockets172 therein and ananvil shaft174 that is removably attachable to thedistal anvil connector150. In particular, acoupling stem176 protrudes from theproximal end175 of theanvil shaft174 and is sized to be slidably received in apassage152 in thedistal anvil connector150. Theanvil170 further has ananvil cap178 thereon as illustrated inFIGS. 5 and 13 that defines atissue cavity179 therein.
• One exemplary method of using thecircular stapler10 will be described with reference toFIGS. 5-16. The various embodiments of thecircular stapler10 are particularly well-suited for performing a circular anastomosis of a tubular organ such as, for example, the colon. Turning first toFIG. 5, thestapler head20 is inserted into aproximal portion201 of thecolon200 through the patient'sanus199. In applications wherein a diseased or targetedportion202 of colon is to be removed, thestapler head20 is positioned adjacent to thediseased portion202. SeeFIG. 6.
• Once thestapler head20 has been inserted to the appropriate position relative to thediseased portion202, thecutter housing100 is advanced distally by axially advancing theknife knob110 in a distal direction (represented byarrows112 inFIGS. 1 and 7). At this stage in the procedure, theknife members120 have not been advanced out of theirrespective knife lumens102. Thereafter, the surgeon advances theacquisition housing70 distally by moving thehook switch90 in the distal direction (arrow92 inFIG. 1). Movement of theacquisition housing70 in the distal direction causes thehook members80 to move axially out of theirrespective acquisition lumens72. As the distal ends of thehook members80 exit theirrespective acquisition lumens72, they naturally flex radially outward to engage and pierce through theproximal portion201 of thecolon200. SeeFIG. 8. Once thehook members80 have pierced and engaged theproximal portion201 of thecolon200, the surgeon moves thehook switch90 in the proximal direction (represented byarrow94 in FIG.1) to retract thehook members80 into theirrespective acquisition lumens72 as well as to retract theacquisition housing100 back to its starting position. Thebarbs84 on the distal ends of thehook members80 draw the engaged theproximal portion201 into the position illustrated inFIG. 9. Thus, the engagedproximal portion201 of thecolon200 is drawn over adistal face31 of thestaple cartridge30 and partially into theinterior space33 between thestaple cartridge30 and thecutter housing100.
• Once the engagedproximal portion201 of thecolon200 has been drawn into the position illustrated inFIG. 9, the surgeon then extends theknife members120 out of theirrespective knife lumens102 by axially advancing theknife knob110 on thehandle assembly12 in the distal direction (represented byarrow112 inFIG. 1). By moving theknife knob110 distally, theknife members120 are advanced out of theirknife lumens102 and thecurved portion104 of eachknife lumen102 causes theknife member120 therein to move radially outward as illustrated inFIG. 10. Theknife members120 protrude through theproximal portion201 of thecolon200 that is proximal to thediseased colon portion202. SeeFIG. 10. Thereafter, thediseased colon portion202 may be severed from theproximal colon portion201 by rotating theknife knob110 on the handle assembly12 (represented byarrow116 inFIG. 1). Rotation/actuation of theknife knob110 will cause thecutter housing100 and theknife members120 to rotate about the central axis A-A and cut through the colon tissue. After thediseased portion202 has been cut away from the proximal colon portion201 (FIG. 11), the surgeon may retract theknife members120 back into theirrespective knife lumens102 by moving theknife knob110 in a proximal direction (represented byarrow114 inFIG. 1). SeeFIG. 12.
• Thediseased portion202 may be severed from the distal colon portion208 (FIG. 13), by means of, for example, a conventional laparoscopic tissue severing device (not shown) that has been inserted through a trocar sleeve that extends into theabdominal cavity601 that is adjacent to thediseased portion202. Thediseased colon portion202 may then be removed through the trocar sleeve. The surgeon then orients theanvil170 within thedistal colon portion206 such that theanvil shaft174 protrudes out of thedistal colon portion206 as shown inFIG. 13. The surgeon then ties the end of thedistal colon portion206 around theanvil shaft174 using what is known in the art as a “purse string suture”220. Once thedistal colon portion206 has been sutured around theanvil shaft174, thecoupling stem176 of theanvil shaft174 is inserted into thepassage152 in theanvil shaft assembly150. Thecoupling stem176 may be sized relative to thepassage152 to establish a frictional fit therebetween to retain thecoupling stem176 therein, yet permit thecoupling stem176 to be removed therefrom at a later time.
• The surgeon then draws theanvil170 toward the stapler head20 (in the proximal direction “PD”) by rotating theanvil control knob160 in the appropriate direction untilcolon portions205,210 are clamped between theanvil170 and thestaple cartridge30 as shown inFIG. 14. Thereafter, the surgeon actuates the firingtrigger60 to axially advance the firingshaft assembly50 in the distal direction “DD”. As firingshaft assembly50 is advanced distally, the outerstaple driver portion54 and the innerstaple driver portion56 serve to drive thestaples36 located in theouter row32 andinner row34, respectively, through thecolon portions205,210 into theanvil forming pockets172 in theanvil base171. The firingshaft assembly50 also advances theannular knife40 through thecolon portion205 to cut theportion201 therefrom. SeeFIG. 15. Further advancement of theannular knife40 severscolon portion207 fromcolon portion208. The surgeon then moves theanvil170 in the distal direction “DD” to release the stapledcolon portions205,210 from between theanvil base171 and theface31 of thestaple cartridge30. SeeFIG. 16. Theinstrument10 may then be removed from thecolon200. Thecut portion201 remains in thestapler head20 and thecut portion207 remains in thetissue cavity179 in theanvil170 as the surgeon withdraws theinstrument10 out through the patient'sanus199. Thus, thecut portions201,207 of thecolon200 are removed from the repaired colon when the instrument is withdrawn therefrom.
• FIG. 17 illustrates anothercircular stapler300 according to various non-limiting embodiments of the invention. Thecircular stapler300 generally includes ahandle assembly312 that has an elongatedshaft314 protruding therefrom. Theelongated shaft314 may define a central axis A-A. As can be seen inFIG. 17, theelongate shaft314 includes a rigidouter sheath316 that supports astapler head320 thereon. In various non-limiting embodiments, thestapler head320 is configured to support acircular staple cartridge330 therein. Such circularstaple cartridges330 are known in the art and generally support one or two or more circumferentially spaced and staggered rows ofstaples36 therein as was described hereinabove. A conventionalannular knife340 is coaxially and movably supported within thestaple cartridge330. SeeFIG. 18.
• In certain implementations, thecircular stapler300 further includes a firingshaft350 that is operably supported within the rigidouter sheath316 for selective axial travel therein as was discussed above. SeeFIG. 18. Adistal end portion352 of the firingshaft350 has an outerstaple driver portion354 thereon for engagement with each of thestaples36 in theouter row32 ofstaples36 in thestaple cartridge330. In addition, thedistal end portion352 of the firingshaft350 has an innerstaple driver portion356 configured for engagement with each of thestaples36 in theinner row34 ofstaples36 within thestaple cartridge330. As can also be seen inFIG. 18, for example, thedistal end portion352 of the firingshaft350 further has a flanged portion358 that is configured to engage theannular knife340. Thus, as will be discussed in further detail below, axial advancement of the firingshaft350 in a distal direction “DD”, will cause thestaples36 to be driven out of thestaple cartridge330 as well as theannular knife340 to advanced distally.
• In various non-limiting embodiments, the firingshaft350 interfaces with a firingtrigger360 that is operably coupled to thehandle assembly312. As can be seen inFIG. 17, the firingtrigger360 is pivotally coupled to thehandle assembly312 such that when the firingtrigger360 is pivoted toward thehandle assembly312, the firingshaft350 is moved in the distal direction DD. As was discussed above, such firing trigger arrangements are known in the art and therefore will not be discussed in detail herein.
• As shown inFIG. 18, various non-limiting embodiments also include adeployment shaft370 that is coaxially and rotatably supported within atissue acquisition shaft380 that is non-rotatably supported within theelongated shaft316. The proximal end of thedeployment shaft370 operably interfaces with atissue acquisition knob310 that is rotatably supported on thehandle assembly312. Thedeployment shaft370 interfaces with thetissue acquisition knob310 in the manner described above with respect toknife knob110. Thus, rotation/actuation of thetissue acquisition knob310 on thehandle assembly312 will result in the rotation of thedeployment shaft370 within thetissue acquisition shaft380 about the central axis A-A. More specifically and with reference toFIG. 19, in various embodiments, adistal end372 of thedeployment shaft370 protrudes through a hole382 in theacquisition shaft380 and has adrive gear374 attached thereto. Adistal end384 of theacquisition shaft380 is configured to operably support at least two tissue acquisition members ortissue arms400 thereon. In the non-limiting embodiment depicted inFIG. 19, a total of fourtissue arms400 are pivotally pinned to thedistal end384 of thetissue acquisition shaft380 by correspondingpins386 such that eachtissue arm400 pivots about a corresponding “acquisition” axis B-B that is substantially parallel to the central axis A-A. SeeFIGS. 21 and 23.
• As can be seen inFIGS. 19 and 22, eachtissue arm400 has abody portion402 that may be fabricated from, for example, stainless steel (300 or 400 series), or titanium-steel composite or ceramic, etc. and have a drivengear404 attached thereto or formed thereon. The drivengear404 of eachtissue arm400 is movably supported within acorresponding arm cavity388 formed in thedistal end384 of thetissue acquisition shaft380. Each drivengear404 is in meshing engagement with thedrive gear374 on thedeployment shaft370. Thus, rotation of thedeployment shaft370 will result in the pivotal deployment of thetissue arms400 from the retracted position depicted inFIG. 20 to the deployed position depicted inFIG. 22. As can be seen inFIGS. 20 and 22, in various embodiments, eachtissue arm400 has an arcuate shape such that when thetissue arms400 are in a retracted position as shown inFIG. 20, they cooperate to create a round disc-like assembly401 at the distal end of thetissue acquisition shaft380.
• In various embodiments, thebody portion402 of eachtissue arm400 further has atissue piercing tip406 formed thereon or otherwise attached thereto. In addition, anarm knife408 that has acutting edge410 formed thereon is attached to or is otherwise formed on thebody portion402 of eachtissue arm400. In various embodiments, thearm knife408 may be fabricated from, for example, stainless steel (300 or 400 series), or titanium-steel composite or ceramic, etc. and be attached to thebody portion402 of thecorresponding tissue arm400 by, depending upon the material, welding or other suitable attachment method. In the preferred embodiments, if thearm knife408 is fabricated from any of the metal materials identified above, it may be desirable for such material to be hardened. For example, a Rockwell hardness value of 38-52 may be desirable. In alternative embodiments, the arm may be fabricated with a thin feature that could be ground to a sharp edge. As will be appreciated as the present Detailed Description proceeds, the blade works more like a scissors rather than a knife as it cuts when closed such that it shears the tissue when408 closes against421. As can also be seen inFIG. 19, ashear plate420 is attached to the distal end382 of thearm shaft380 by threadedfasteners422 that extend into threaded fastener bores424 in thearm shaft380. Also in various embodiments, a plurality of tissue acquisition pins426 are equally spaced around the circumference of thetissue acquisition shaft380 and protrude radially therefrom. Theouter edge421 of theshear plate420 cooperates with the cutting edges410 on thetissue arms400 to shear off tissue that is drawn between thoseedges410,421 as thetissue arms400 are moved to their retracted position.
• In certain implementations, adistal end post442 protrudes from a portion of the firingshaft350 that coaxially extends within thedeployment shaft370 for selective axial travel therein. Thedistal end post442 supports adistal anvil connector450 therein that is coupled to anadjustment knob460 that is rotatably supported on thehandle assembly312 in the various manners discussed above.
• Thecircular stapler300 further includes ananvil470 as shown inFIG. 18. In various non-limiting embodiments, theanvil470 includes ananvil base471 that has a series ofstaple forming pockets472 therein. Theanvil base471 may further define ashear edge473 for facilitating the shearing of tissue by theannular knife340. Theanvil470 further includes ananvil shaft474 that is removably attachable to thedistal anvil connector450. In particular, acoupling stem476 protrudes from theproximal end475 of theanvil shaft474 and is sized to be slidably received in apassage452 in theanvil shaft assembly450. SeeFIG. 23. Theanvil assembly470 further has ananvil cap478 thereon that serves to define atissue cavity479 therein as illustrated inFIGS. 18 and 23. As can also be seen inFIG. 18, the disc-like assembly401 is sized to extend into anopening475 in theanvil base471.
• One exemplary method of using thecircular stapler300 will be described with reference toFIGS. 23-31. The various embodiments of thecircular stapler300 are particularly well-suited for performing a circular anastomosis of a tubular organ such as, for example, acolon200. Turning first toFIG. 23, thestapler head320 is inserted through the patient'sanus199 into aproximal portion201 of thecolon200. When a diseased or otherwise targetedportion202 ofcolon200 is to be removed, thestapler head320 is positioned in an area wherein thediseased portion202 is to be severed from theproximal portion201.
• Once thestapler head320 has been properly positioned within the colon, thetissue arms400 may be radially deployed by rotating thetissue acquisition knob310 in a first direction (represented byarrow311 inFIG. 17) which also rotates thedeployment shaft370. Rotation of thedeployment shaft370 in the first direction also rotates thedrive gear374 which is in meshing engagement with the drivengear portions404 of eachtissue arm400. Thus, rotation of thedrive gear374 in the first direction causes thetissue arms400 to be radially deployed. As thetissue arms400 are radially deployed, the tissue-piercingtips406 thereof pierce through theproximal portion201 ofcolon200. SeeFIGS. 24 and 25. Once thetissue arms400 have been deployed such that the tissue-piercingtips406 thereof have pierced through theproximal portion201 ofcolon200, the surgeon may then rotate thetissue acquisition knob310 in a second direction (represented byarrow313 inFIG. 17) to move thetissue arms400 to the retracted position. As thetissue arms400 are retracted, they gather the piercedproximal portion201 ofcolon200 and draw it inward toward thetissue acquisition shaft380. As the gatheredcolon201 is drawn between theshear plate420 and the tissue arms, theportion201 of thecolon200 that is captured between theouter edge421 of theshear plate420 and the cutting edges410 on thetissue arms400 is severed from thediseased portion202 of thecolon200. Retraction of thetissue arms400 causes theportion201 of thecolon200 to be impaled onto the tissue retention pins426 and retained thereon as shown inFIG. 26. Thereafter, thediseased portion202 of thecolon200 may be transected from thedistal colon portion208 using a conventional laparoscopic tissue severing instrument (not shown) inserted through a trocar sleeve inserted into theabdominal cavity601. After thediseased portion202 has been cut away from thedistal colon portion208, thediseased portion202 may be removed through the trocar sleeve (not shown) with a conventionalgrasping instrument600. SeeFIG. 26.
• The surgeon then orients theanvil170 within thedistal portion208 of thecolon200 such that the anvilshaft coupling stem476 of theanvil shaft474 protrudes out of thedistal portion208 of thecolon200 as shown inFIG. 28. The surgeon then ties the end of thedistal colon portion208 around theanvil shaft474 using what is known in the art as a “purse string suture”220. Once thedistal colon portion208 has been sutured around theanvil shaft474, thecoupling stem476 of theanvil shaft474 is inserted into thepassage452 in theanvil shaft assembly450. Thecoupling stem476 is sized relative to thepassage152 to establish a frictional fit therebetween to retain thecoupling stem176 therein, yet permit thecoupling stem176 to be removed therefrom at a later time. SeeFIG. 28.
• The surgeon then draws theanvil470 toward the stapler head420 (in the proximal direction “PD”) by rotating theanvil control knob460 in the appropriate direction untilportions205,210 of thecolon200 are clamped between theanvil470 and thestaple cartridge330 as shown inFIG. 29. Thereafter, the surgeon actuates the firingtrigger360 to axially advance the firingshaft350 in the distal direction “DD”. As firingshaft350 is advanced distally, thestaple driver portions354,356 serve to drive thestaples36 through theportions205,210 ofcolon200 into theanvil forming pockets472 in theanvil470. The firingshaft350 also advances theannular knife340 through thecolon portions205,210 to severportions201,207, respectively therefrom. The surgeon may then move theanvil470 in the distal direction “DD” to release the stapledcolon portions205,210 from between theanvil470 and thestapler head320. Theinstrument300 may then be removed from thecolon200. SeeFIG. 31. The severedportions201,207 of thecolon200 remain in thestapler head320 and theanvil470, respectively as the surgeon withdraws theinstrument300 out through the patient's anus. Thus, the severedportions201,207 of thecolon200 are removed from the repaired colon when theinstrument300 is withdrawn therefrom.
• Circular stapling instruments are generally introduced through the anus and not from the abdomen side of the pelvis. Such method of entry complicates the ability of the surgeon to visualize the tumor, the tumor's necessary margins and those margin edges with respect to the distal transection location to ensure that the stapler head has been properly positioned in the colon before commencing the transection.FIGS. 32-37 illustrate acircular stapler700 according to various non-limiting embodiments of the invention that may provide feedback to the surgeon during the insertion process. Thecircular stapler700 generally includes ahandle assembly712 that has an elongatedshaft assembly714 protruding therefrom. Theelongated shaft assembly714 may define a central axis A-A. As can be seen inFIG. 32, theelongate shaft assembly714 includes a rigidouter sheath716 that has a distal end portion that supports astapler head720 thereon. In various non-limiting embodiments, thestapler head720 is configured to operably support acircular staple cartridge730 therein. Such circularstaple cartridges730 are known in the art and generally may support one, two or more than two circumferentially spaced and staggered rows of staples therein. In the non-limiting embodiment depicted inFIG. 33, thestaple cartridge730 supports tworows732,734 ofstaples36 therein. A conventionalannular knife740 is coaxially and movably supported within thestapler head720.
• Thecircular stapler700 further includes a firingshaft750 that is operably supported within the rigidouter sheath716 for selective axial travel therein. SeeFIG. 33. Adistal end portion752 of the firingshaft750 has an outerstaple driver portion754 thereon for engagement with each of thestaples36 in theouter row732 ofstaples36 in thestaple cartridge730. In addition, thedistal end portion752 of the firingshaft assembly750 has an innerstaple driver portion756 that is configured for engagement with each of thestaples36 in theinner row734 ofstaples36 within thestaple cartridge730. As can also be seen inFIG. 33, for example, thedistal end portion752 of the firingshaft750 further has aflanged portion758 that is configured to engage theannular knife740. Thus, as will be discussed in further detail below, axial advancement of the firingshaft750 in a distal direction “DD”, will cause thestaples36 to be driven out of thestaple cartridge730 as well as theannular knife740 to advanced distally.
• In various non-limiting embodiments, the firingshaft750 interfaces with a firingtrigger760 that is operably coupled to thehandle assembly712. As can be seen inFIG. 32, the firingtrigger760 is pivotally coupled to thehandle assembly712 such that when the firingtrigger760 is pivoted toward thehandle assembly712, the firingshaft750 is moved in the distal direction DD as was discussed above.
• As shown inFIG. 33, various non-limiting embodiments include a hook anddetection housing770 that is coaxially supported within the firingshaft750 and axially movable therein. The hook anddetection housing770 has a plurality ofhook lumens772 therein that each movably supports anacquisition hook member780 therein. As can be seen inFIG. 34, for example, the plurality of three-sided hook lumens772 may be equally spaced around the circumference of the hook anddetection housing770. For example, in the non-limiting embodiment depicted inFIG. 34, a total of eight (8)hook lumens772 are equally spaced around the circumference of the hook anddetection housing770. Eachhook member780 may be fabricated from, for example, Nitinol, 300 or 400 series stainless steel (fully or three-fourths hardened), etc. and have adistal end portion782 that, when advanced out of itsrespective hook lumen772, naturally flexes or bends radially outward in the manners described above. As with other embodiments, eachacquisition hook member780 may have atissue barb784 formed on thedistal end portion782 thereof. As can be seen inFIGS. 33 and 34, in various non-limiting embodiments, the hook anddetection housing770 includes ahook sleeve778 that facilitates installation of theacquisition hook members780 into theirrespective lumens772.
• In various non-limiting embodiments, a proximal end portion of the hook anddetection housing770 may operably interface with ahook switch790 that is operably supported on thehandle712. SeeFIG. 32. As the surgeon moves thehook switch790 in a distal direction (arrow792 inFIG. 32), the hook anddetection housing770 moves distally. In addition, eachacquisition hook member780 is advanced distally out of itsrespective hook lumen772 as was described above. The surgeon may retract thehook members780 into their starting positions by moving thehook switch790 in a proximal direction (arrow794 inFIG. 32).
• Also supported within the hook anddetection housing770 are a plurality offlexible detection members781. In particular, aplurality detection lumens774 are also provided in the hook anddetection housing770. For example, in the non-limiting embodiment depicted inFIG. 34, a total of eight (8)detection lumens774 are equally spaced around the circumference of the hook anddetection housing770. In one non-limiting embodiment, eachdetection member781 may be fabricated from, for example, polyethylene, Nylon, Nitinol, titanium etc. and have adistal end portion783 that, when deployed out of itsrespective detection lumen774, naturally flexes or bends radially outward as illustrated inFIG. 35. In addition, a substantially blunt orrounded bumper785 may be provided on the distal end of eachdetection member781. In one embodiment, the bumper may be fabricated from, for example, Sanoprene, Isoprene, natural rubber, polypropylene, polyethylene, Nylon, etc. In other embodiments, thebumper785 may comprise a light or light emitting diode (LED). In those embodiments, a conductor may extend from a battery in thehandle assembly712 or other energy source through a lumen in thedetection member781 to the light785.
• In various non-limiting embodiments, a proximal end portion of eachdetection member770 may interface with adetection knob791 that is operably supported on thehandle assembly712. SeeFIG. 32. As the surgeon rotates thedetection knob791 in a first direction (arrow793 inFIG. 32), thedetection members781 deploy distally out of their respective lumens in a radial direction away from central axis A-A to deployed positions (FIG. 36). In various embodiments, for example, all of thedetection members781 may be attached to a round sleeve (not shown) that is slidably supported within theouter sheath716. The round sleeve may further have a gear rack attached thereto that is received in meshing engagement with a gear (not shown) on the underside of thedetection knob791. Rotation of thedetection knob791 in one direction moves the sleeve distally and therefore extends all of thedetection members781. When the surgeon rotates thedetection knob791 in a second direction (arrow795 inFIG. 32), thedetection members781 are drawn back into theirrespective detection lumens774 to the retracted position. SeeFIG. 34. Other switches and drive arrangements could also be employed to selectively extend and retract the detection members without departing from the spirit and scope of the present invention.
• As can be further seen inFIG. 33, in various non-limiting embodiments, acutter housing800 is coaxially supported within the hook anddetection housing770. Thecutter housing800 is supported for selective axial travel relative to the hook anddetection housing770 and for selective axial travel along central axis A-A. Thecutter housing800 interfaces with aknife knob810 that is movably supported on thehandle assembly712. SeeFIG. 32. In various non-limited embodiments, theknife knob810 is supported on thehandle assembly712 such that it can move axially (represented byarrows812,814 inFIG. 32) and also be rotated relative to the handle assembly712 (represented byarrow816 inFIG. 32). Thecutter housing800 may be attached to theknife knob810 in the various manners described above such that movement of theknife knob810 in an axial direction moves thecutter housing800 axially within the hook anddetection housing770 and rotation of theknife knob810 also rotates thecutter housing800 about the central axis A-A.
• In various non-limiting embodiments, thecutter housing800 includes a plurality ofknife lumens802 that extend axially through the wall of thecutter housing800. As was discussed above with respect to other embodiments, the plurality ofknife lumens802 may be spaced equally around the circumference of thecutter housing800. For example, in a non-limiting embodiment, a total of eight (8)knife lumens802 may be equally spaced around the circumference of thecutter housing800. As can be seen inFIG. 33, eachknife lumen802 has a curveddistal end portion804 that opens radially outward.
• In various non-limiting embodiments, aflexible knife member820 is slidably received within eachknife lumen802. Eachflexible knife member820 has a sharpeneddistal end822 and a proximal end (not shown) that interfaces with aknife switch830 that is operably mounted to thehandle712 in the various manners described above. SeeFIG. 32. Thedistal end822 may be substantially pointed to enable it to pierce through tissue and it may have at least one cutting edge formed thereon. When theknife switch830 is moved in the distal direction (arrow832), theknife members820 are moved distally within theknife lumens802 such that the sharpeneddistal end822 naturally flexes or bends radially out of the curveddistal end portion804 of thelumen802 as was described above. Likewise, movement of theknife switch830 in the proximal direction (represented byarrow834 inFIG. 32), causes theknife members820 to be retracted back into theirrespective knife lumen802. In various non-limiting embodiments, theknife members820 may be fabricated from, for example, Nitinol, 300 or 400 series stainless steel (fully of three-fourths hardened).
• As can also be seen inFIG. 33, various non-limiting embodiments may further include ananvil shaft assembly840 that is coaxially supported within thecutter housing800 for selective axial travel therein. Theanvil shaft assembly840 may comprise adistal end post842 that protrudes from a portion of the firingshaft firing shaft750. Thedistal end post842 supports adistal anvil connector850 therein that that protrudes distally from thedistal end post842. Theanvil shaft assembly840 has a proximal end portion that interfaces with anadjustment knob760 that is rotatably supported on thehandle assembly712 as was discussed above with respect to other non-limiting embodiments. Thecircular stapler700 further includes ananvil170 as shown inFIG. 32.
• One exemplary method of using thecircular stapler700 will now be described. To commence the procedure, the surgeon inserts theelongated shaft714 through the patient'sanus199 into aproximal portion201 of thecolon200. Thereafter, the surgeon may extend thedetection members781 as illustrated inFIGS. 36 and 37 to “fine tune” the positioning of thestapler head720. This may be accomplished by rotating thedetection knob791 in the appropriate direction. As thebumpers785 are forced radially into the wall ofcolon portion201, they create identifiable bumps ordeflections203 or irregular areas that protrude outward and provide means for the surgeon to visually observe where thestapler head720 is located. Such identifiable features are distinct from the actual anatomy of the colon wall. The substantially blunted or rounded bumpers do not penetrate or damage the colon wall.Such bumps203 allow the surgeon to position thestapler head720 relative to the tumor ordiseased portion202 of the colon. If one or more of thebumpers785 comprise lights, the surgeon may view the lights through the colon wall as indicated inFIG. 37.
• Once the surgeon has located thestapler head720 in the desired location within theproximal portion201 of thecolon200, the surgeon may then retract thedetection members781 into the hook anddetection housing770 by rotating thedetection knob791 in a direction that is opposite to the direction in which thedetection members781 were caused to be extended. Theacquisition hook members780 may then be extended to pierce through and acquire the adjacent portions of theproximal colon wall201. In alternative embodiments, however, the surgeon may elect to maintain thedetection members781 in their extended positions as shown inFIG. 37. In doing so, thedetection members781 may produce some “hoop stress” in the colon wall which may assist in the acquisition and piercing of theproximal colon wall201 by theacquisition hook members780.
• To cause the acquisition hooks780 to engage and penetrate theproximal colon portion201, the surgeon advances the hook anddetection housing770 distally by moving thehook switch790 in the distal direction (arrow792 inFIG. 32). Movement of the hook anddetection housing770 in the distal direction causes theacquisition hook members780 to move axially out of theirrespective hook lumens772. As the distal ends of theacquisition hook members780 exit theirrespective hook lumens772, they move radially outward to engage and pierce through adjacent portions of theproximal colon wall201. SeeFIG. 37. Once thehook members780 have pierced and engaged the adjacent portions of theproximal colon wall201, the surgeon moves thehook switch790 in the proximal direction (represented byarrow794 inFIG. 32) to retract theacquisition hook members780 into theirrespective hook lumens772 as well as retract the hook anddetection housing770 back to its starting position. Thebarbs784 on the distal ends of theacquisition hook members780 draw the engaged portions of theproximal colon wall201 into a position similar to the position illustrated inFIG. 9. Once the portions of theproximal colon portion201 have been drawn into the position illustrated inFIG. 9, the surgeon may then complete the procedure by performing the same actions described above with respect to thecircular stapler10.
• FIG. 38 illustrates anothercircular stapler900 according to various non-limiting embodiments of the invention. Thecircular stapler900 generally includes ahandle assembly912 that has an elongatedshaft914 protruding therefrom. Theelongated shaft914 may define a central axis A-A. As can be seen inFIG. 38, theelongate shaft914 includes a rigidouter sheath916 that has astapler head920 located at thedistal end917 thereof. In various non-limiting embodiments, thestapler head920 is configured to operably support acircular staple cartridge930 therein. Such circularstaple cartridges930 are known in the art and may generally support one, two, or more than two circumferentially spaced and staggered rows ofstaples36 therein as was described hereinabove. A conventionalannular knife940 is coaxially and movably supported within thestapler head920. SeeFIG. 39.
• Thecircular stapler900 further includes a firingshaft950 that is supported within the rigidouter sheath916 for selective axial travel therein. SeeFIG. 39. Adistal end portion952 of the firingshaft950 has an outerstaple driver portion954 thereon for engagement with each of thestaples36 in theouter row32 ofstaples36 in thestaple cartridge930. In addition, thedistal end portion952 of the firingshaft950 has an innerstaple driver portion956 configured for engagement with each of thestaples36 in theinner row34 ofstaples36 within thestaple cartridge930. As can also be seen inFIG. 39, for example, thedistal end portion952 of the firingshaft assembly950 further has aflanged portion958 that is configured to engage theannular knife940. Thus, as will be discussed in further detail below, axial advancement of the firingshaft950 in a distal direction “DD”, will cause thestaples36 to be driven out of thestaple cartridge930 as well as theannular knife940 to advanced distally.
• In various non-limiting embodiments, the firingshaft950 may interface with a firingtrigger960 that is operably coupled to thehandle assembly912. SeeFIG. 38. As can be seen inFIG. 38, the firingtrigger960 may be pivotally coupled to thehandle assembly912 such that when the firingtrigger960 is pivoted toward thehandle assembly912, the firingshaft950 is moved in the distal direction DD. As was discussed above, such firing trigger arrangements are known in the art and therefore will not be discussed in detail herein.
• As shown inFIG. 39, various non-limiting embodiments may also include ahollow deployment shaft970 that is coaxially supported within a hollowtissue acquisition shaft980. The proximal end of thedeployment shaft970 is operably attached to anarm deployment knob910 that is rotatably supported on thehandle assembly912 in the various manners described above. Thus, rotation of thearm deployment knob910 on thehandle assembly912 will result in the rotation of thedeployment shaft970 about the central axis A-A. More specifically and with reference toFIG. 40, in various embodiments, adistal end972 of thedeployment shaft970 protrudes through ahole982 in thetissue acquisition shaft980 and has adrive gear974 attached thereto. Adistal end984 of thetissue acquisition shaft980 is configured to operably support at least one tissue acquisition member orarm1000 thereon. Two ormore tissue arms1000 are preferable. In the non-limiting embodiment depicted inFIG. 40, a total of fourtissue arms1000 are pivotally pinned to thedistal end984 of thetissue acquisition shaft980 by correspondingpins986.
• Eachtissue arm1000 may have abody portion1002 that may be fabricated from, for example, stainless steel (300 or 400 series), titanium, titanium-steel composite, ceramic, etc. and have a drivengear1004 attached thereto or formed thereon. The drivengear1004 of eachtissue arm1000 is movably supported within acorresponding arm cavity988 formed in thedistal end984 of thetissue acquisition shaft980. Each drivengear1004 is in meshing engagement with thedrive gear974 on thedeployment shaft970. Thus, rotation of thedeployment shaft970 will result in the pivotal deployment of thetissue arms1000 from the retracted position depicted inFIG. 41 to the deployed position depicted inFIG. 42. In various embodiments, thebody portion1002 of eachtissue arm1000 may further have atissue piercing tip1006 formed thereon or otherwise attached thereto.
• In various embodiments, aknife shaft1010 is coaxially received within thedeployment shaft970 and interfaces with a knife knob1020 (FIG. 38) rotatably supported on thehandle assembly912 such that rotation of theknife knob1020 results in the rotation of theknife shaft1010. Theknife shaft1010 further has adistal end1012 that protrudes out of the distal ends972,984 of thedeployment shaft970 and thetissue acquisition shaft980, respectively. SeeFIG. 40. Aknife1030 may be removably attached to thedistal end1012 of theknife shaft1010 by, for example, pins1032 or other suitable fasteners. In various embodiments, theknife1030 may be substantially planar and have diametrically opposed tissue-piercingpoints1031,1033 formed thereon as shown inFIG. 40.
• As can also be seen inFIG. 39, various non-limiting embodiments may further include ananvil shaft assembly440 that includes adistal end post442 that protrudes from a portion of the firingshaft950 that coaxially extends within thedeployment shaft970 for selective axial travel therein. Thedistal end post442 supports adistal anvil connector450 therein that is coupled to anadjustment knob460 that is rotatably supported on thehandle assembly312 in the various manners discussed above.
• Thecircular stapler900 further includes ananvil470 as shown inFIG. 39. In various non-limiting embodiments, theanvil470 includes ananvil base471 that has a series ofstaple forming pockets472 therein. Theanvil base471 may further define ashear edge473 for facilitating the shearing of tissue by theannular knife940. Theanvil470 may further include ananvil shaft474 that is removably attachable to thedistal anvil connector450. In particular, acoupling stem476 protrudes from theproximal end475 of theanvil shaft474 and is sized to be slidably received in apassage452 in theanvil shaft assembly450. Theanvil470 may further have ananvil cap478 thereon that serves to define atissue cavity479 therein as illustrated inFIG. 39.
• One exemplary method of using thecircular stapler900 will be described with reference to FIGS.39 and43-51. Turning first toFIG. 39, thestapler head920 is inserted into a tubular organ such as thecolon200 through the patient'sanus199. Thestapler head920 is located in theproximal portion201 of thecolon200 that is adjacent to adiseased portion202. Thereafter, thetissue arms1000 are radially deployed by rotating thearm deployment knob910 in a first direction (represented byarrow911 inFIG. 38) which also rotates thedeployment shaft970. Rotation of thedeployment shaft970 in the first direction also rotates thedrive gear974 which is in meshing engagement with the drivengear portions1004 of eachtissue arm1000. Thus, rotation of thedrive gear974 in the first direction causes thetissue arms1000 to be radially deployed. As thetissue arms1000 are radially deployed, thetissue piercing tips1006 thereof pierce throughproximal portion201 of thecolon200. SeeFIGS. 44 and 45. The surgeon may then rotate thearm deployment knob910 in the opposite or second direction (represented byarrow913 inFIG. 38) to retract thetissue arms1000 into their retracted position (FIG. 20). As thetissue arms1000 are retracted, the piercedproximal portion201 of thecolon200 is carried by thetissue arms1000 such that theportion201 is gathered between thetissue arms1000 and thearm shaft980 in a confronting position adjacent thestaple cartridge930. Thereafter, the surgeon may rotate theknife knob1020 to cause theknife1030 to rotate and sever thediseased portion202 of thecolon200 from the proximal portion of thecolon201. Thediseased portion202 may be transected from adistal portion208 of the colon using a conventional laparoscopic tissue severing instrument (not shown) inserted through a trocar sleeve (not shown) positioned in theabdominal cavity601. After thediseased portion202 has been cut away from theproximal portion201 of thecolon200 and thedistal portion208, thediseased portion202 may be removed through the trocar sleeve with a conventionalgrasping instrument600. SeeFIG. 48.
• The surgeon may then orient theanvil470 within thedistal portion208 of thecolon200 such that the anvilshaft coupling stem476 of theanvil shaft474 protrudes out of thedistal portion208 of thecolon200 as shown inFIG. 49. The surgeon may then tie the end of thedistal colon portion208 around theanvil shaft474 using what is known in the art as a “purse string suture”220. Once thedistal colon portion208 has been sutured around the anvil shaft,474, thecoupling stem476 of theanvil shaft474 is inserted into thepassage452 in theanvil shaft assembly450. Thecoupling stem476 may be sized relative to thepassage452 to establish a frictional fit therebetween to retain thecoupling stem476 therein, yet permit thecoupling stem476 to be removed therefrom at a later time. SeeFIG. 49.
• The surgeon then draws theanvil470 toward the stapler head920 (in the proximal direction “PD”) by rotating theanvil control knob460 in the appropriate direction untilportions205,210 of thecolon200 are clamped between theanvil470 and thestaple cartridge930 as shown inFIG. 50. Thereafter, the surgeon actuates the firingtrigger960 to axially advance the firingshaft950 in the distal direction “DD”. As firingshaft950 is advanced distally, thestaple driver portion954 serves to drive thestaples36 through theportions205,210 ofcolon200 into theanvil forming pockets472 in theanvil base471. The firingshaft950 also advances theannular knife940 to sever thecolon portions201,207 fromcolon portions205,210 respectively. The surgeon may then move theanvil470 in the distal direction “DD” to release the stapledcolon portions205,210 from between theanvil470 and thestapler head920. Theinstrument900 may then be removed from thecolon200. SeeFIG. 51. The severedportion207 is captured in theanvil cavity479 and the severedportion201 is retained between thetissue arms1000 and thearm shaft980. Thus, thecut portions201,207 of thecolon200 are removed from the repaired colon when theinstrument900 is withdrawn therefrom.
• As the surgeon performs the above described procedures or other related procedures in that region of the body, care has to be taken to avoid inadvertently damaging adjacent soft tissues and bone structures.FIGS. 52 and 53 illustrate some of the adjacent tissue and bone structures that are adjacent to thecolon200. InFIG. 52, theperitoneum1100 has been dissected to illustrate, for example, thesphincter ani1101, thesacrotuberous ligament1102, theischtal tuberosity1104, theischiorectal fossa1106,levator ani1108, and the thirdsacral vertebra1110.FIG. 53 further illustrates the pararectal fossa1112, thesacrogenital fold1114, theureter1116, the ductus diferens1118, thebladder1120, theparavesical fossa1122, and the transvesical folds1124. The surgeon must also be careful not to damage the muscles, nerves, vessels and arteries along the inter wall of theperitoneum1100 when accessing the portion of thecolon200 to be transected.
• FIGS. 54-57 illustrate use of aprotective sheath1200 of a non-limiting embodiment of the present invention. In various embodiments, thesheath1200 may be fabricated from, for example, Kevlar, polyethylene, Nylon, etc. and be stressed in a fashion that naturally makes it want to coil. SeeFIG. 55. In various embodiments, measurement orreference indicia1202 may be provided on thesheath1200 to assist the surgeon in locating the operable portion of a surgical instrument (e.g., the stapler head of a circular stapler) and to prevent accidental damage of adjacent nerves, vessels and tissue. In still other embodiments, thesheath1200 may be fabricated from a magnetic sensitive film that would enable it to be magnetically attracted to the operable portion of the instrument to protect the adjacent anatomical structures and tissues from, for example, portions of the instrument that might damage adjacent tissues, muscles, bones, nerves, etc. if the instrument portions were brought into inadvertent contact therewith. In further alternative embodiments, thesheath1200 may have a magnetic interaction ring or portion that is attracted to the stapler head. Thus, at least a portion of thesheath1200 may be magnetic or otherwise have magnetic material attached thereto.
• Thesheath1200 may be installed through acannula1252 of aconventional trocar1250 that is laparoscopically inserted through the abdominal wall into the abdominal cavity as shown inFIG. 54. A conventional laparoscopicgrasping instrument600 may be used as shown inFIGS. 54 and 55 to remove thesheath1200 from thetrocar cannula1252. Thereafter, the surgeon may wrap the unrolledsheath1200 around thecolon200 using conventionalgrasping devices600 as shown inFIG. 56.FIG. 57 illustrates thesheath1200 after it has been wrapped around thecolon200 and prior to commencing insertion of the circular stapling instrument into the colon. The natural coiling nature of the sheath serves to retain it in a coiled orientation about thecolon200.
• Thesheath1200 of the present invention may be effectively employed to protect adjacent tissues and organs during use of any of the above-mentioned embodiments. See, for example,FIGS. 5-16,23-31,36,39, and43-51, wherein thesheath1200 has been installed around thecolon200 in the above-described manner. In addition, the non-limiting embodiments of thesheath1200 may be effectively used in connection with conventional circular stapling devices and the like without departing from the spirit and scope of the present invention. For those instrument embodiments that employ lights on the detection members or the like, thesheath1200 may be fabricated from, for example, light sensitive film that would cause portions of thesheath1200 to change color in those areas adjacent to the lighted detection members. See For example, the non-limiting embodiment depicted inFIG. 36.
• The various embodiments of the present invention represent a vast improvement over prior circular staple arrangements and procedures associated therewith. While several embodiments of the invention have been described, it should be apparent, however, that various modifications, alterations and adaptations to those embodiments may occur to persons skilled in the art with the attainment of some or all of the advantages of the invention. For example, according to various embodiments, 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. This application is therefore intended to cover all such modifications, alterations and adaptations without departing from the scope and spirit of the disclosed invention as defined by the appended claims.
• Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this 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 invention which is intended to be protected is not to be construed as limited to the particular embodiments disclosed. The embodiments are therefore to be regarded as illustrative rather than restrictive. Variations and changes may be made by others without departing from the spirit of the present invention. Accordingly, it is expressly intended that all such equivalents, variations and changes which fall within the spirit and scope of the present invention as defined in the claims be embraced thereby.

Claims (20)

1. A device for protecting tissues and structures adjacent to a tubular organ during performance of a surgical procedure on a portion of the tubular organ, said device comprising a member that may be deployed through a surgical instrument in a first configuration and expanded to a second configuration such that when in said second configuration, said protective member may extend substantially around an outer circumference of the portion of the tubular organ.

2. The protective member ofclaim 1 wherein said protective member comprises a sheath fabricated from material selected from the group of materials consisting of polyisoprene, polyethylene, polypropylene and Kevlar.

3. The protective member ofclaim 2 wherein said material is prestressed to make it naturally assume a coiled shape.

4. The protective member ofclaim 1 further comprising a magnetic attractive portion that is magnetically attracted to a portion of a surgical instrument.

5. The protective member ofclaim 1 wherein said protective member has reference indicia thereon.

6. The protective member ofclaim 1 wherein at least a portion thereof is fabricated from light-sensitive material that will change color when adjacent to a lighted portion of a surgical instrument.

7. A procedure for protecting tissues and structures adjacent to a tubular organ within an abdominal cavity during the manipulation and operation of surgical instruments within a target portion of the tubular organ, the procedure comprising:

introducing a protective sheath into the abdominal cavity adjacent to the target portion;

surrounding the target portion of the tubular organ with the protective sheath; and

retaining the protective sheath in position surrounding the target portion.

8. The procedure ofclaim 7 wherein said introducing comprises:

inserting a hollow cannula into the abdominal cavity; and

passing the protective sheath through the hollow cannula into the abdominal cavity.

9. The procedure ofclaim 8 wherein said protective sheath is prestressed to make it naturally assume a coiled shape.

10. The procedure ofclaim 7 further comprising:

inserting a surgical instrument into the target portion of the tubular organ; and

magnetically affixing the protective sheath to a portion of the surgical instrument.

11. A surgical procedure for treating a tubular organ, said surgical procedure comprising:

introducing a protective sheath into a portion of an abdominal cavity adjacent to a target portion of the tubular organ;

surrounding the target portion of the tubular organ with the protective sheath;

retaining the protective sheath in position surrounding the target portion;

inserting a circular stapler head of a surgical instrument into the target portion of the tubular organ; and

deploying at least one lighted detection member operably supported by the surgical instrument from a retracted position to a deployed position adjacent a wall of the target portion of the tubular organ adjacent the protective sheath such that the adjacent portion of the protective sheath changes its observable color to indicate the position of the circular stapler head within the target portion of the tubular organ.

12. The procedure ofclaim 11 wherein said introducing comprises:

inserting a hollow cannula into the abdominal cavity; and

passing the protective sheath through the hollow cannula into the abdominal cavity.

13. The procedure ofclaim 11 wherein said protective sheath is prestressed to make it naturally assume a coiled shape.

14. A surgical procedure for treating a target portion of a patient's colon, said surgical procedure comprising:

inserting a hollow cannula of a trocar through an abdominal wall into an abdominal cavity adjacent to a target portion of the colon;

coiling a protective sheath;

passing the coiled sheath through the hollow cannula into the abdominal cavity;

uncoiling the sheath; and

positioning the uncoiled sheath around the target portion of the colon such that a natural coiling tendency of the protective sheath retains the protective sheath in a position around an outer circumference of the target portion of the colon.

15. The surgical procedure ofclaim 14 further comprising inserting a portion of surgical instrument into the target portion of the colon through the patient's anus.

16. The surgical procedure ofclaim 15 further comprising assessing a position of the surgical instrument portion within the target portion of the colon.

17. The surgical procedure ofclaim 16 wherein said assessing comprises:

activating at least one light on the portion of the surgical instrument within the target portion; and

observing the at least one light through the protective sheath.

18. The surgical procedure ofclaim 17 wherein at least a portion of the protective sheath changes color when exposed to light and wherein said observing comprises observing a portion of the protective sheath that has changed color in response to the activation of the at least one light on the portion of the surgical instrument within the target portion.

19. The surgical procedure ofclaim 15 further comprising deploying a tissue cutting portion of the portion of surgical instrument within the target portion.

20. The surgical procedure ofclaim 15 further comprising:

completing a surgical procedure on the target portion with the surgical instrument;

withdrawing the surgical instrument portion from the target portion of the colon through the patient's anus; and

withdrawing the protective sheath out of the abdominal cavity through the hollow trocar cannula.

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