• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
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    • 专利摘要:
    Transoral circular anvil introduction system with dilatation feature. The invention relates to an anvil delivery system that is operable to provide smooth insertion of an anvil (240) from a surgical stapling device (10) through a lumen of the body, such as the esophagus. the anvil introduction system is coupled to the anvil (240) and includes an expansion feature (210). the expansion feature (210) has a retracted position and an expanded position. the dilator feature (210) can cover the staple pockets (252) and an outer edge of the anvil (240) with the dilator feature (210) in the expanded position. the anvil (240) can be inserted through the lumen of the body with the dilatation feature (210) in the expanded position. the dilatation feature (210) can then be retracted to complete an anastomosis across the lumen of the body.
    公开号:BR112015013062B1
    申请号:R112015013062-3
    申请日:2013-12-04
    公开日:2021-08-31
    发明作者:Frederick E. Shelton Iv；Charles J. Scheib；John P. Measamer
    申请人:Ethicon Endo-Surgery, Inc.；
    IPC主号:
    专利说明:

    BACKGROUND
    [001] In some configurations, a surgeon may wish to position a surgical instrument through a patient's orifice and use the instrument to adjust, position, secure and/or otherwise interact with tissues within the patient. For example, in some surgical procedures, portions of the gastrointestinal tract may be cut and removed to eliminate unwanted tissue, or for other reasons. Once the desired tissue has been removed, it may be necessary to re-attach the remaining portions. One of the tools for performing these anastomotic procedures is a circular stapler that is inserted through a patient's orifice.
    [002] Examples of surgical circular staplers are described in US Patent No. 5,205,459 entitled "Surgical Anastomosis Stapling Instrument", issued April 27, 1993; US Patent No. 5,271,544 entitled "Surgical Anastomosis Stapling Instrument", issued December 21, 1993; US Patent No. 5,275,322, entitled "Surgical Anastomosis Stapling Instrument", issued January 4, 1994; US Patent No. 5,285,945 entitled "Surgical Anastomosis Stapling Instrument", issued February 15, 1994; US Patent No. 5,292,053 entitled "Surgical Anastomosis Stapling Instrument", issued March 8, 1994; US Patent No. 5,333,773 entitled "Surgical Anastomosis Stapling Instrument", issued August 2, 1994; US Patent No. 5,350,104 entitled "Surgical Anastomosis Stapling Instrument", issued September 27, 1994; and US Patent No. 5,533,661 entitled "Surgical Anastomosis Stapling Instrument", issued July 9, 1996. The description of each of the above-cited US patents is incorporated herein by reference. Some such staplers are operable to staple tissue layers, cut through the tissue layers stapled together, and push the staples through the tissue layers to substantially seal the separate tissue layers near the separate ends of the tissue layers, joining , thus, two separate ends of an anatomical lumen.
    Merely additional examples of surgical staplers are set forth in US Patent No. 4,805,823 entitled "Pocket Configuration for Internal Organ Staplers", issued January 21, 1989; U.S. Patent No. 5,415,334 entitled "Surgical Stapler and Staple Cartridge", issued May 16, 1995; U.S. Patent No. 5,465,895 entitled "Surgical Stapler Instrument", issued November 14, 1995; US Patent No. 5,597,107 entitled "Surgical Stapler Instrument", issued January 28, 1997; US Patent No. 5,632,432 entitled "Surgical Instrument", issued May 27, 1997; US Patent No. 5,673,840 entitled "Surgical Instrument", issued October 7, 1997; US Patent No. 5,704,534 entitled "Articulation Assembly for Surgical Instruments", issued January 6, 1998; US Patent No. 5,814,055 entitled "Surgical Clamping Mechanism", issued September 29, 1998; US Patent No. 6,978,921 entitled "Surgical Stapling Instrument Incorporating an E-Beam Firing Mechanism", issued December 27, 2005; U.S. Patent No. 7,000,818 entitled "Surgical Stapling Instrument Having Separate Distinct Closing and Firing Systems", issued February 21, 2006; U.S. Patent No. 7,143,923 entitled "Surgical Stapling Instrument Having a Firing Lockout for an Unclosed Anvil", issued December 5, 2006; US Patent No. 7,303,108 entitled "Surgical Stapling Instrument Incorporating a Multi-Stroke Firing Mechanism with a Flexible Rack", issued December 4, 2007; US Patent No. 7,367,485 entitled "Surgical Stapling Instrument Incorporating a Multistroke Firing Mechanism Having a Rotary Transmission", issued May 6, 2008; US Patent No. 7,380,695 entitled "Surgical Stapling Instrument Having a Single Lockout Mechanism for Prevention of Firing", granted June 3, 2008; US Patent No. 7,380,696 entitled "Articulating Surgical Stapling Instrument Incorporating a Two-Piece E-Beam Firing Mechanism", granted June 3, 2008; US Patent No. 7,404,508 entitled "Surgical Stapling and Cutting Device", issued July 29, 2008; U.S. Patent No. 7,434,715 entitled "Surgical Stapling Instrument Having Multiple Strokes of Firing with Aperture Lock", granted on October 14, 2008; and US Patent No. 7,721,930 entitled "Disposable Cartridge with Adhesive for Use with a Stapling Device", issued May 25, 2010. The description of each of the above-cited US patents is incorporated herein by way of reference. Although the aforementioned surgical staplers are described as being used in endoscopic procedures, it should be understood that these surgical staplers can also be used in open procedures and/or other non-endoscopic procedures.
    [004] Although various types of surgical stapling instruments and associated components have been manufactured and used, it is believed that no one prior to the inventors has manufactured or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS
    [005] Although the specification concludes with claims that specifically indicate and distinctly claim this technology, it is believed that this technology will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which they reference numbers identify the same elements and where:
    [006] Figure 1 represents a side elevation view of an example of a surgical instrument for circular stapling;
    [007] Figure 2A represents an enlarged longitudinal cross-sectional view of an exemplary stapling head assembly of the instrument of Figure 1, showing an exemplary anvil in an open position,
    [008] Figure 2B represents an enlarged longitudinal cross-sectional view of the clamping head assembly of Figure 2A, showing the anvil in a closed position,
    [009] Figure 2C represents an enlarged longitudinal cross-sectional view of the stapling head assembly of Figure 2A, showing a staple driver and an exemplary blade in a fired position;
    [0010] Figure 3 represents an enlarged partial cross-sectional view of an exemplary clamp formed against the anvil,
    [0011] Figure 4A is an enlarged side elevation view of an exemplary actuator cable assembly of the surgical instrument of Figure 1, with a portion of the body removed, showing a trigger in an unfired position and a locking feature in a locked position,
    [0012] Figure 4B represents an enlarged side elevation view of the actuator cable assembly of Figure 4A, showing the trigger in a fired position and the locking feature in an unlocked position,
    [0013] Figure 5 represents an enlarged partial perspective view of an exemplary indicator assembly of the surgical instrument of Figure 1, showing an indicator window and an indicator lever,
    [0014] Figure 6 represents a diagrammatic view of the indicator window of Figure 5, showing an exemplary indicator bar and corresponding exemplary clamp representations,
    [0015] Figure 7 illustrates a schematic view of an exemplary circular stapler system being used in an esophagectomy procedure;
    [0016] Figure 8 illustrates an enlarged partial perspective view of a transoral circular anvil delivery system showing an expansion feature in a deflated state;
    [0017] Figure 9A illustrates a cross-sectional view of the anvil introduction system of Figure 7, showing the expansion feature in the deflated state;
    [0018] Figure 9B illustrates a cross-sectional view of the anvil delivery system of Figure 7 showing the expansion feature in an inflated state;
    [0019] Figure 10 illustrates an enlarged partial perspective view of the anvil delivery system of Figure 7 showing the dilation feature in the inflated state passing through a lumen;
    [0020] Figure 11 illustrates an enlarged partial perspective view of another exemplary transoral circular anvil delivery system showing an expansion feature in an expanded state;
    [0021] Figure 12 illustrates a cross-sectional view of the anvil delivery system of Figure 11 taken along line 12-12 of Figure 11;
    [0022] Figure 13 illustrates an enlarged partial perspective view of the anvil introduction system of Figure 11 showing the expansion feature in the expanded state with a meshed cover;
    [0023] Figure 14 illustrates a cross-sectional view of the anvil introduction system of Figure 13;
    [0024] Figure 15 illustrates an enlarged partial perspective view of the anvil introduction system of Figure 11 showing the expansion feature in a retracted state with a meshed cover;
    [0025] Figure 16 illustrates a cross-sectional view of the anvil introduction system of Figure 15;
    [0026] Figure 17A illustrates an enlarged partial perspective view of the anvil delivery system of Figure 11 passing through a lumen;
    [0027] Figure 17B illustrates an enlarged partial perspective view of the anvil delivery system of Figure 11, showing the anvil delivery system removed from the anvil;
    [0028] Figure 18 illustrates an enlarged bottom perspective view of an exemplary anvil with a grip feature;
    [0029] Figure 19A illustrates an enlarged partial perspective view of the anvil of Figure 18, showing the anvil in an inserted position into a lumen;
    [0030] Figure 19B illustrates an enlarged partial perspective view of the anvil of Figure 18, showing the rotation of the anvil within the lumen;
    [0031] Figure 19C illustrates an enlarged partial perspective view of the anvil of Figure 18, showing the anvil approaching a clamping position within the lumen;
    [0032] Figure 20 illustrates an enlarged top perspective view of another exemplary anvil with a gripping feature;
    [0033] Figure 21A illustrates a cross-sectional view of the anvil of Figure 20, showing an anvil locking feature in a retracted state;
    [0034] Figure 21B illustrates a cross-sectional view of the anvil of Figure 20, showing the anvil locking feature in an expanded state;
    [0035] Figure 22A illustrates an enlarged partial perspective view of an exemplary anvil attachment feature within a lumen, showing the lumen being sutured in a purse-string configuration; and
    [0036] Figure 22B illustrates an enlarged partial perspective view of the anvil fixation feature of Figure 22A showing the lumen in an adjusted position and secured to the anvil by suture.
    [0037] The drawings are not intended to be limiting in any way, and it is contemplated that various modalities of the technology may be performed in a variety of other ways, including those not necessarily represented in the drawings. The drawings incorporated in the annex and forming a part of the descriptive report illustrate various aspects of the present technology, and together with the description they serve to explain the principles of the technology; it is understood, however, that this technology is not limited precisely to the provisions shown. DETAILED DESCRIPTION
    [0038] The following description of some examples of the technology should not be used to limit its scope. Other examples, elements, aspects, modalities and advantages of the technology will become evident to those skilled in the art with the following description, which is through illustrations, one of the best ways contemplated for carrying out the technology. As will be understood, the technology described here is capable of other different and obvious aspects, all without departing from the technology. Consequently, the drawings and descriptions are to be regarded as illustrative in nature and not restrictive. I. Overview of the exemplary surgical instrument for circular stapling
    [0039] Figures 1 to 6 represent an example of circular surgical stapling instrument 10, having a stapling head assembly 20, a rod assembly 60 and an actuator cable assembly 70, each of which will be described in detail below. Stem assembly 60 extends distally from actuator cable assembly 70, and clamping head assembly 20 is coupled to a distal end of stem assembly 60. In summary, actuator cable assembly 70 functions in such a way as to activating a staple driver 24 of the staple head assembly 20 to drive a plurality of staples 66 out of the staple head assembly 20. To form finished staples, staples 66 are bent by an anvil 40 that is secured to the distal end. of instrument 10. Consequently, tissue 2 shown in Figures 2A to 2C can be stapled using instrument 10.
    [0040] In the present example, the instrument 10 comprises a closing system and a triggering system. The closure system comprises a trocar 38, a trocar actuator 39 and a rotary knob 98. An anvil 40 can be coupled to a distal end of the trocar 38. The rotary knob 98 is intended to longitudinally translate the trocar 38 with respect to the assembly of clamping head 20, thus translating the anvil 40 when it 40 is coupled to the trocar 38, to clamp the tissue between the anvil 40 and the clamping head assembly 20. The firing system comprises a trigger 74, a drive assembly of trigger 84, a trigger actuator 64, and a staple trigger 24. The staple trigger 24 includes a knife 36 configured to cut tissue when the staple trigger 24 is actuated longitudinally. In addition, clips 66 are positioned distally to a plurality of clip drive elements 30 of clip driver 24, so that clip driver 24 also drives clips 66 distally when clip driver 24 is actuated longitudinally. Thus, when trigger 74 is actuated and trigger drive assembly 84 actuates clamp driver 24 via drive actuator 64, knife 36 and elements 30 substantially simultaneously cut tissue 2 and drive the staples 66 distally to the staple head assembly 20 and into tissue. The components and functionalities of the closing system and the triggering system will now be described in more detail. A. Anvil example
    [0041] As shown in Figures 1 to 2C, the anvil 40 is selectively attachable to the instrument 10 to provide a surface against which the clips 66 can be folded to staple the material contained between the clipping head assembly 20 and the anvil 40. The anvil 40 of the present example is selectively attachable to a trocar or sharpened rod 38, which extends distally to the clamping head assembly 20. Referring to Figures 2A through 2C, the anvil 40 is selectively attachable upon attachment from a proximal shaft 42 of the incus 40 to a distal tip of the trocar 38. The incus 40 comprises a generally circular anvil head 48 and a proximal shaft 42 extending proximally from the head of the incus 48. In the example shown, the proximal shaft 42 comprises a tubular member 44 having resiliently slanted retaining tabs 46 to selectively couple the anvil 40 to the trocar 38, although this is It is only optional, and it should be understood that other retention features for attaching the anvil 40 to the trocar 38 may also be used. For example, C-clips, staples, threads, pins, stickers, etc. may be employed to couple the incus 40 to the trocar 38. Furthermore, although the incus 40 is described as selectively attachable to the trocar 38, in some versions the proximal rod 42 may include a one-way coupling feature so that, once fixed, the anvil 40 cannot be removed from the trocar 38. Merely exemplary unidirectional elements include barbs, unidirectional snap buttons, tweezers, collars, flaps, bands, etc. Of course still other configurations for coupling anvil 40 to trocar 38 will be apparent to one of skill in the art in view of the teachings of the present invention. For example, trocar 38 may instead be a hollow shaft, and proximal shaft 42 may comprise a sharpened shaft that can be inserted into the hollow shaft.
    [0042] The anvil head 48 of the present example comprises a plurality of clip-forming pockets 52 formed on a proximal face 50 of the anvil head 48. Consequently, when the anvil 40 is in the closed position and the clips 66 are driven to outside the staple head assembly 20 and into the staple forming pockets 52, as shown in Figure 2C, legs 68 of staples 66 are bent to form finished staples.
    [0043] With the anvil 40 as a separate component, it should be understood that the anvil 40 can be inserted and secured to a portion of tissue 2 before being coupled to the stapling head assembly 20. By way of example only, the anvil 40 can be inserted and secured to a first tubular tissue portion 2, while the instrument 10 is inserted and secured to a second tubular tissue portion 2. For example, the first tubular tissue portion 2 can be sutured to or around a portion of the incus 40, and the second tubular tissue portion 2 may be sutured in or around the trocar 38.
    [0044] As shown in Figure 2A, the incus 40 is then coupled to the trocar 38. The trocar 38 of the present example is shown in a more distal actuated position. This extended position of the trocar 38 can provide a larger area to which tissue 2 can be attached, prior to attachment of the incus 40. In addition, the extended position of the trocar 38 can also provide easier attachment of the incus 40 to the trocar. 38. Trocar 38 additionally includes a tapered distal tip. This tip may be capable of piercing through tissue, and/or assisting in the insertion of incus 40 into trocar 38, although the tapered distal tip is merely optional. For example, in other versions the trocar 38 may have a non-piercing tip. Additionally, or alternatively, the trocar 38 may include a magnetic portion not shown that can attract the incus 40 towards the trocar 38. Of course, other configurations and arrangements for the incus 40 and the trocar 38 will be apparent to those skilled in the art, in view of the teachings contained herein.
    [0045] When the anvil 40 is coupled to the trocar 38, the distance between a proximal face of the anvil 40 and a distal face of the clamping head assembly 20 defines a span distance d. The trocar 38 of the present example is translatable longitudinally with respect to the clamping head assembly 20 by means of an adjustment knob 98 located at a proximal end of the actuator cable assembly 70, as will be described in more detail below. Consequently, when the anvil 40 is coupled to the trocar 38, rotation of the adjustment knob 98 extends or reduces the span distance d by actuating the anvil 40 relative to the clamping head assembly 20. For example, as shown sequentially in Figures 2A to 2B, the anvil 40 is shown acting proximally to the actuator cable assembly 70, from an initial open position to a closed position, thus reducing the gap distance between the two portions of 2 fabric to be joined. When the gap distance is placed within a predetermined range, the stapling head assembly 20 can be heated, as shown in Figure 2C, to staple and cut the fabric 2 between the anvil 40 and the stapling head assembly 20. stapling head assembly 20 is intended to staple and cut fabric 2 by a user turning a trigger 74 of actuator cable assembly 70, as will be described in more detail below. In some other versions, the clamping head assembly 20 is actuated via a motor or is otherwise driven.
    [0046] As noted above, the span distance d corresponds to the distance between the anvil 40 and the stapling head assembly 20. When instrument 10 is inserted into a patient, this span distance d may not be easily visible. Accordingly, a movable indicator bar 110, shown in Figures 5 to 6, is arranged to be visible through an indicator window 120 positioned opposite the trigger 74. The indicator bar 110 is intended to move in response to rotation of the knob. setting 98 so that the position of the indicator bar 110 is representative of the span distance d. As shown in Figure 6, the indicator window 120 further comprises a scale 130 which indicates that the anvil span is in a desired operating range e.g. a green colored region or "green zone" and a representation of compression of corresponding staple at each full scale 130. By way of example only, as shown in Figure 6, a first staple image 132 represents a large staple height, while a second staple image 134 represents a small staple height. Consequently, a user can view the position of the coupled anvil 40 relative to the clamping head assembly 20 via the indicator bar 110 and the scale 130. The user can then adjust the positioning of the anvil 40 via the adjustment knob 98 as needed.
    [0047] Referring again to Figures 2A to 2C, a user sutures a portion of the fabric 2 around the tubular element 44 so that the head of the anvil 48 is situated on a portion of the fabric 2 to be stapled. When tissue 2 is secured to anvil 40, retaining tabs 46 and a portion of tubular member 44 protrude from tissue 2 so that the user can attach anvil 40 to trocar 38. With tissue 2 attached to tissue 2 trocar 38 and/or the other portion of the stapling head assembly 20, the user attaches the anvil 40 to the trocar 38 and drives the anvil 40 proximally toward the stapling head assembly 20 to reduce the gap distance d. When the instrument 10 is within the operating range, the user then staples the ends of the fabric 2, thus forming a substantially contiguous tubular portion of the fabric 2.
    The anvil 40 may further be constructed in accordance with at least some of the teachings of US Patent No. 5,205,459; US Patent No. 5,271,544; US Patent No. 5,275,322; US Patent No. 5,285,945; US Patent No. 5,292,053; US Patent No. 5,333,773; US Patent No. 5,350,104; U.S. Patent No. 5,533,661, the disclosures of which are incorporated herein by reference; and/or in other embodiments, as will be apparent to one skilled in the art in view of the teachings of the present invention. B. Example Stapling Head Assembly
    [0049] The clamping head assembly 20 of the present example is coupled to a distal end of the rod assembly 60 and comprises a tubular housing 22 housing a sliding clamp driver 24 and a plurality of clamps 66 contained in the clamp pockets 32. Clamps 66 and staple pockets 32 are disposed in a circular array around tubular housing 22. In the present example, staples 66 and staple pockets 32 are arranged in a pair of concentric annular rows of staples 66 and staple pockets 32. clamp driver 24 is intended to actuate longitudinally within tubular housing 22 in response to rotation of trigger 74 of actuator cable assembly 70. As shown in Figures 2A to 2C, clamp driver 24 comprises a flared cylindrical element having a trocar opening 26, a central recess 28 and a plurality of elements 30 circumferentially disposed around the central recess 28 and extending distally. and with respect to rod assembly 60. Each element 30 is configured to contact, and engage with, a corresponding clip 66 of the plurality of clips 66 in clip pockets 32. Consequently, when clip actuator 24 is actuated distal to the actuator cable assembly 70, each element 30 drives a corresponding clip 66 out of its clip pocket 32 through a clip opening 34 formed in a distal end of the tubular housing 22. extends from the staple driver 24, the plurality of staples 66 are driven out of the staple head assembly 20 at substantially the same time. When the anvil 40 is in the closed position, the staples 66 are driven into staple-forming pockets 52 for flexing the legs 68 of the staples 66, thereby staple the material located between the anvil 40 and the staple head assembly 20. Figure 3 depicts a merely exemplary staple 66 carried by an element 30 in a staple-forming pocket 32 of the anvil 40 for flexing the legs 68.
    [0050] The staple driver 24 additionally includes a cylindrical knife 36 that is coaxial to the opening of the trocar 26 and insertion of the staple pockets 32. In the present example, the cylindrical knife 36 is disposed within the central recess 28 to translate distally with the staple driver 24. When the anvil 40 is secured to the trocar 38, as described above, the head of the anvil 48 provides a surface against which the cylindrical knife 36 cuts the material contained between the anvil 40 and the clamping head assembly 20 In some versions, the anvil head 48 may include a recess not shown for the cylindrical knife 36 to help cut material, for example, by providing a cooperative cutting edge. Additionally, or alternatively, the anvil head 48 may include one or more opposing cylindrical knife knives not shown offsetting the cylindrical knife 36 so that it can provide a scissor-like cutting action. Still other configurations will be evident to those skilled in the art in view of the teachings contained herein. The stapling head assembly 20 thus functions both to staple and to cut the fabric 2 substantially simultaneously in response to actuation by the actuator cable assembly 70.
    [0051] Logically, the clamping head assembly 20 can be further constructed in accordance with at least some of the teachings of US Patent No. 5,205,459; US Patent No. 5,271,544; US Patent No. 5,275,322; US Patent No. 5,285,945; US Patent No. 5,292,053; US Patent No. 5,333,773; US Patent No. 5,350,104; U.S. Patent No. 5,533,661, the disclosures of which are incorporated herein by reference; and/or in other embodiments, as will be apparent to one skilled in the art in view of the teachings of the present invention.
    [0052] As noted earlier, the staple driver 24 includes a trocar opening 26. The trocar opening 26 is configured to allow the trocar 38 to slide longitudinally with respect to the clamping head assembly 20 and/or stem assembly 60 As shown in Figures 2A to 2C, the trocar 38 is coupled to a trocar actuator 39 so that the trocar 38 can be actuated longitudinally by rotating the rotary knob 98, as will be described in more detail below with reference to the assembly. of actuator cable 70. In the present example, the trocar actuator 39 comprises an elongated, relatively rigid rod coupled to the trocar 38, although this is merely optional. In some versions, actuator 39 can comprise a longitudinally rigid material while allowing lateral flexion so that portions of instrument 10 can be selectively flexed or curved during use; or instrument 10 may include a previously prepared bent rod assembly 60. A merely exemplary material is nitinol. When the anvil 40 is coupled to the trocar 38, the trocar 38 and the anvil 40 are translatable via the actuator 39 to adjust the gap distance d between the anvil 40 and the clamping head assembly 20. Yet other additional configurations for that the actuator 39 longitudinally actuating the trocar 38 will be evident to the person skilled in the art, in view of the teachings contained herein. C. Rod Assembly Example
    [0053] The stapling head assembly 20 and the trocar 38 are positioned at a distal end of the stem assembly 60, as shown in Figures 2A through 2C. The rod assembly 60 of the present example comprises an outer tubular member 62 and a drive actuator 64. The outer tubular member 62 is coupled to the tubular sheath 22 of the clamping head assembly 20 and to a body 72 of the actuator cable assembly 70 , thus offering mechanical support for the actuating components contained therein. The proximal end of the trigger actuator 64 is coupled to a trigger trigger assembly 84 of the actuator cable assembly 70, described below. The distal end of actuating actuator 64 is coupled to clamp actuator 24 so that rotation of trigger 74 longitudinally actuates clamp actuator 24. As shown in Figures 2A to 2C, actuating actuator 64 comprises a tubular member having a longitudinal axis open so that the actuator 39 coupled to the trocar 38 can actuate longitudinally and in relation to the actuating actuator 64. It should be understood, of course, that other components may be disposed within the actuating actuator 64, as will become evident to the person versed in the technique, in view of the teachings contained herein.
    The rod assembly 60 may be further constructed in accordance with at least some of the teachings of US Patent No. 5,205,459; US Patent No. 5,271,544; US Patent No. 5,275,322; US Patent No. 5,285,945; US Patent No. 5,292,053; US Patent No. 5,333,773; US Patent No. 5,350,104; U.S. Patent No. 5,533,661, the disclosures of which are incorporated herein by reference; and/or in other embodiments, as will be apparent to one skilled in the art in view of the teachings of the present invention. D. Example of Actuator Cable Assembly
    [0055] Now referring to Figures 4A to 5, the actuator handle assembly 70 comprises a body 72, a trigger 74, a lockout feature 82, a trigger drive assembly 84 and a trocar drive assembly 90. The trigger 74 of the present example is pivotally mounted to the body 72 and is coupled to the trigger drive assembly 84 so that the trigger drive 74 rotates from an unfired position shown in Figure 4A to a fired position shown in Figure 4B drive the drive actuator 64 described above. A spring 78 is coupled to the body 72 and the trigger 74 to bias the trigger 74 toward the unfired position. The locking feature 82 is a pivoting element that is coupled to the body 72. In a first, locked position, the locking feature 82 is pivoted up and away from the body 72 so that the locking feature 82 engages the trigger. 74 and mechanically resists triggering of trigger 74 by a user. In a second unlocked position, as shown in Figures 1 and 4B, the locking feature 82 is rotated downward so that the trigger 74 can be actuated by the user. Consequently, with the locking feature 82 in the second position, the trigger 74 can engage a trigger drive assembly 84 to trigger the instrument 10.
    [0056] As shown in Figures 4A and 4B, the trigger drive assembly 84 of the present example comprises a sliding trigger carriage 86 engaged with a proximal end of the trigger actuator 64. The carriage 86 includes a set of tabs 88 on a proximal end of carriage 86 to retain and engage a pair of trigger arms 76 extending from trigger 74. Consequently, when trigger 74 is rotated, carriage 86 is longitudinally actuated and transfers longitudinal movement to the actuating actuator. 64. In the example shown, carriage 86 is fixedly coupled to the proximal end of drive actuator 64, although this is merely optional. Indeed, in a merely alternative example, carriage 86 may simply be in a position abutting drive actuator 64, while a distal spring not shown biases drive actuator 64 proximally with respect to actuator cable assembly 70.
    [0057] Trigger actuation assembly 84 may be further constructed in accordance with at least some of the teachings of US Patent No. 5,205,459; US Patent No. 5,271,544; US Patent No. 5,275,322; US Patent No. 5,285,945; US Patent No. 5,292,053; US Patent No. 5,333,773; US Patent No. 5,350,104; U.S. Patent No. 5,533,661, the disclosures of which are incorporated herein by reference; and/or in other embodiments, as will be apparent to one skilled in the art in view of the teachings of the present invention.
    [0058] The body 72 also houses a trocar drive assembly 90 configured to drive the trocar 38 longitudinally in response to rotation of the adjustment knob 98. As best shown in Figures 4A through 5, the trocar drive assembly 90 of the present example comprises the adjustment knob 98, a splined stem 94 and a sleeve 92. The splined stem 94 of the present example is situated at a distal end of the trocar actuator 39, although it should be understood that the splined stem 94 and the actuator The trocar 39 may alternatively be separate components that engage to impart longitudinal movement. Adjustment knob 98 is pivotally supported by the proximal end of body 72, and functions to rotate sleeve 92 which is engaged with splined rod 94 by means of an inner tab not shown. The splined rod 94 of the present example comprises a continuous groove 96 formed in the outer surface of the splined rod 94. Consequently, when the adjustment knob 98 is rotated, the inner tab moves within the groove 96 and the splined rod 94 is actuated longitudinally with respect to sleeve 92. As the splined rod 94 is situated at the distal end of the trocar actuator 39, turning the adjustment knob 98 in a first direction advances the trocar actuator 39 distally with respect to the actuator handle assembly 70. Consequently , the gap distance d between the anvil 40 and the clamping head assembly 20 is increased. By turning the adjustment knob 98 in the opposite direction, the trocar actuator 39 is actuated proximally to the actuator cable assembly 70 to reduce the span distance d between the anvil 40 and the clamping head assembly 20. Thus, the trocar driving assembly 90 is intended to drive the trocar 38 in response to the b Rotary Adjustment Knob 98. Of course, other configurations for the Trocar Drive Assembly 90 will be apparent to the person skilled in the art in view of the teachings contained herein.
    The groove 96 of the present example comprises a plurality of different portions 96A, 96B, 96C having a different range or number of grooves per axial distance. The present groove 96 is divided into a distal portion 96A, a middle portion 96B and a proximal portion 96C. As shown in Figure 5, a distal portion 96A comprises a fine pitch or a high number of grooves along a short axial distance from the splined rod 94 so that a large number of rotations of adjustment knob 98 are required to travel the short axial distance. The middle portion 96B comprises a section with comparably thicker gap or with fewer grooves per axial distance so that relatively few rotations are needed to traverse a long axial distance. Consequently, the span distance d can be quickly reduced by relatively few rotations of the adjustment knob 98. The proximal portion 96C of the present example is substantially similar to the distal portion 96A and comprises a thin gap or a high number of grooves for a short axial distance from the splined rod 94 so that a large number of rotations is needed to traverse the short axial distance. The proximal portion 96C of the present example is positioned on the sleeve 92 when the anvil 40 is substantially close to the clamping head assembly 20 so that an indicator bar 110 moves within the indicator window 120 along the scale 130 to indicate the span. the anvil is within a desired operating range as will be described in detail below. Consequently, when the tab is within the proximal portion 96C of the groove 96, each rotation of the adjustment knob 98 can reduce the gap distance d to a small amount to provide fine tuning.
    The trocar actuation assembly 90 can be further constructed in accordance with at least some of the teachings of US Patent No. 5,205,459; US Patent No. 5,271,544; US Patent No. 5,275,322; US Patent No. 5,285,945; US Patent No. 5,292,053; US Patent No. 5,333,773; US Patent No. 5,350,104; U.S. Patent No. 5,533,661, the disclosures of which are incorporated herein by reference; and/or in other embodiments, as will be apparent to one skilled in the art in view of the teachings of the present invention.
    [0061] In the example shown in Figures 4A to 4B, a U-shaped loop 100 is secured to an intermediate portion of the trocar actuator 39 located distally from the splined rod 94. In the present example, an extension of the trocar actuator 39 engages a slot in cable assembly housing 70 to prevent trocar 39 actuator from rotating about its axis when adjustment knob 98 is rotated. In some other versions, the U-shaped clip 100 engages with a body portion 72 to substantially prevent the trocar actuator 39 from rotating about its axis when the adjustment knob 98 is rotated. The U-shaped tab 100 of the present example further includes an elongated slot 102 on each of its opposite sides for receiving a fastener, such as a screw, bolt, pin, clip, etc., to selectively adjust the longitudinal position of the elongated slit 102 of the U-shaped loop 100 with respect to the trocar actuator 39, for the purpose of calibrating the indicator bar 110 with respect to the scale 130.
    [0062] As shown in Figure 5, the actuator cable assembly 70 further includes an indicator bracket 140 configured to engage and rotate an indicator 104. The indicator bracket 140 of the present example is slidable relative to the body 72 along a pair of slots formed in body 72. Indicator bracket 140 comprises a rectangular plate 144, indicator arm 146, and angled flange 142. Angle flange 142 is formed at the proximal end of rectangular plate 144, and includes an opening (not shown) to be slidably mounted on the trocar actuator 39 and/or the splined rod 94. A coil spring 150 is interposed between the flange 142 and a protrusion 152 to bias the flange 142 against the U-shaped clip 100. Consequently, when the u-shaped cleat 100 acts distally with the trocar actuator 39 and/or the splined rod 94, the coil spring 150 forces the indicator bracket 140 to move distally with the u-shaped cleat 100. In this, the U-shaped clamp 100 forces the indicator bracket 140 proximally to the protrusion 152 as the trocar actuator 39 and/or the splined rod 94 are moved proximally, thus compressing the coil spring 150. you should understand that, in some versions, indicator bracket 140 may be fixedly attached to trocar actuator 39 and/or grooved rod 94.
    [0063] In the present example, a portion of the locking feature 82 abuts a surface 141 of the indicator bracket 140 when said indicator bracket 140 is in a longitudinal position that does not correspond to when the anvil span is within a desired operating range (for example, a green colored region or "green zone"). When the anvil span is within a desired operating range (eg, a green colored region or "green zone"), the indicator bracket 140 thins to provide a pair of spans 145 on either side of an indicator arm 146 which allows the locking feature 82 to rotate, thereby releasing the trigger 74. Consequently, the locking feature 82 and the indicator bracket 140 can substantially prevent a user from releasing and operating the trigger 74 until the anvil 40 is in a range of default operation. It should be understood, of course, that lockout feature 82 may be omitted entirely in some versions.
    [0064] This operating range may be visually communicated to the user by means of an indicator bar 110 of an indicator 104 shown against a scale 130, described briefly above. At the distal end of the index bracket 140 is a distally extending index arm 146 that terminates in a laterally extending finger 148 to control movement of the index 104. The index arm 146 and finger 148, best shown in Figure 5, are configured to engage the a tab 106 of indicator 104 so that indicator 104 is rotated when indicator bracket 140 is actuated longitudinally. In the present example, indicator 104 is pivotally coupled to body 72 at a first end of indicator 104, although this is merely optional, and other pivot points of indicator 104 will be apparent to one of ordinary skill in the art in view of the teachings contained herein. . An indicator bar 110 is positioned at the second end of indicator 104 such that indicator bar 110 moves in response to actuation of indicator bracket 140. Consequently, as discussed above, indicator bar 110 is displayed through an indicator window 120 against a scale 130 (shown in Figure 6) to show the relative span distance d between the anvil 40 and the clamping head assembly 20.
    [0065] Logically, the indicator bracket 140, the indicator 104, and/or the actuator cable assembly 70 can be further constructed in accordance with at least some of the teachings of US patent No. 5,205,459; US Patent No. 5,271,544; US Patent No. 5,275,322; US Patent No. 5,285,945; US Patent No. 5,292,053; US Patent No. 5,333,773; US Patent No. 5,350,104; U.S. Patent No. 5,533,661, the disclosures of which are incorporated herein by reference; and/or in other embodiments, as will be apparent to one skilled in the art in view of the teachings of the present invention. II. Exemplary transoral circular anvil introduction system
    [0066] As described above, the anvil 40 can be provided as a separate component so that the anvil 40 can be inserted and secured to a portion of tissue 2 before being coupled to the stapling head assembly 20. For example, it can It would be desirable to introduce the incus 40 transorally for procedures into a patient's gastrointestinal tract eg, an esophagectomy. Figure 7 illustrates an early stage of an anastomosis procedure to attach separate sections of the esophagus 2, 4 following an esophagectomy. Anvil 40 is inserted transorally permeable from the esophagus with the use of an endoscope 6 and is positioned within a separate first section 2 of the esophagus. The instrument 10 is inserted through the stomach and is positioned within a separate second section 4 of the esophagus. Anvil 40 is then coupled to trocar 38 of instrument 10 to staple and seal separate sections 2, 4 of the esophagus at an anastomosis. Anvil 40 may also be inserted into other body lumens or regions of the gastrointestinal tract to perform an anastomosis, as will be apparent to one skilled in the art in view of the teachings of the present invention. As improper introduction of incus 40 can irritate the esophagus, it may be desirable to provide a transoral circular incus delivery system to gently insert incus 40 through the body lumen. An anvil delivery system may comprise dilating features to cover at least the proximal side of the anvil 40 during insertion, if not the entire anvil 40 during insertion; or the system may comprise anvil gripping features for inserting the anvil 40 upside down so that the proximal side of the anvil 40 faces away from the tissue. Several examples of such features will be described in greater detail below, while other examples will be apparent to one of skill in the art in view of the teachings of the present invention. A. Exemplary expansion features
    [0067] An anvil delivery system may comprise anvil dilating features that inflate or expand to cover the proximal side of the anvil 40 during insertion. Such dilation features can prevent an outer perimeter edge on the proximal side of the incus 40 from dragging along the inner wall of the esophagus as the incus 40 is transported across the esophagus to reach the desired anastomotic site. Several examples of such features will be described in more detail below, while other examples will be apparent to one skilled in the art in view of the teachings of the present invention. 1. Exemplary inflatable resource
    [0068] An exemplary transoral circular anvil delivery system 200 is shown in Figures 8 to 10. The anvil delivery system 200 of the present example comprises an expansion feature, such as an inflatable bladder 210, that is expandable around the anvil. 240 to cover any sharp edge of anvil 240 when introducing anvil 240 through a naturally occurring body lumen (eg, the esophagus). For example, the anvil delivery system 200 comprises an anvil 240, an inflatable bladder 210, and a flexible tube 222, as shown in Figure 8. The anvil 240 is similar to the anvil 40 described above. Anvil 240 comprises clip pockets 252 aligned on the proximal surface 250 of anvil 240. Anvil 240 also comprises a proximally extending rod 244. Rod 244 is coupled to inflatable bladder 210. Inflatable bladder 210 comprises a flexible membrane which encircles the stem 244 and inflates to cover the staple pockets 252 and the edge of the proximal surface 250 of the anvil 240, as shown in Figure 9B. In the inflated state, bladder 210 defines a tapered shape from anvil 240. Openings 211 are provided in rod 244 to allow air, saline, or other fluid to pass through rod 244 to inflate bladder 210. Tubular member 212 extends from bladder 210 to selectively couple bladder 210 to flexible tube 222. A shaft 244 is similar to proximal shaft 42 of anvil 40 such that shaft 244 is configured to engage trocar 38 once anvil 240 is positioned for stapling.
    Flexible tube 222 comprises a snap fit feature 220 and an inflation tube 224. Push fit feature 220 extends from the distal end of flexible tube 222. Push fit feature 220 comprises a diameter smaller than the tubular member 212 so that the snap fit feature 220 slides or snaps on the tubular member 212 to couple the flexible tube 222 to the tubular member 212, as shown in Figure 9A. The push-fit feature 220 may also have a larger diameter than the tubular member 212 so that the push-fit feature 220 slides around the tubular member 212. The push-fit feature 220 may also be sutured to the member. tubular 212. Other suitable methods for coupling flexible tube 222 to tubular member 212 will be apparent to those of skill in the art based on the teachings of the present invention. Inflation tube 224 is positioned within flexible tube 222. Inflation tube can be used to inject fluid into bladder 210 to inflate bladder 210. However, inflation tube 224 is merely optional and flexible tube 222 can be used to inject fluid into bladder 210. Flexible tube 222 may comprise a conventional naso-gastric NG tube or any other suitable structure.
    [0070] As shown in Figure 9A, the snap fit feature 200 is inserted into tubular member 212 to couple flexible tube 222 to tubular member 212. Once coupled, inflation tube 224 introduces fluid into bladder 210 to inflate the bladder 210, as shown in Figure 9B. With the inflated bladder 210, the bladder 210 covers the clip pockets 252. The bladder 210 also extends beyond the anvil 240 to form an annular bulge 214 to cover the edge of the proximal surface 250 of the anvil 240. In the inflated state, the tube flexible 222 is used to gently pull the anvil 240 through the naturally occurring body lumen (eg, the esophagus) as shown in Figure 10. Once the anvil 240 is positioned by the anvil delivery system 200, the bladder 210 is deflated by passing fluid back through inflation tube 224. Flexible tube 222 is then removed from anvil 240, and anvil 240 is coupled to trocar 38 of circular surgical stapling instrument 10 for operation. 2. Exemplary expandable network resource
    [0071] Another exemplary transoral circular anvil delivery system 300 comprising an expansion feature is shown in Figures 11 to 17B. The anvil introducing system 300 comprises an anvil 340, a flexible tube 322, a slider feature 360, and an expansion feature 361. The anvil 340 is similar to the anvil 40 described above. Anvil 340 comprises clip pockets 352 aligned on proximal surface 350 of anvil 340, as shown in Figure 15. Anvil 340 also comprises a shank 344 extending from proximal surface 350 of anvil 340. Shank 344 is similar to anvil 340. proximal rod 42 of anvil 40 such that rod 344 is configured to mate with trocar 38 once anvil 340 is positioned for clamping. Stem 344 is coupled to flexible tube 322 as anvil 340 is moved into a position for clamping. Rod 344 comprises a smaller diameter than flexible tube 322 so that rod 344 slides into flexible tube 322 to couple flexible tube 322 to anvil 340. Rod 344 may also have a larger diameter than flexible tube 322 so that rod 344 can slide around flexible tube 322. Rod 344 may also be sutured to flexible tube 322 through corresponding openings 312, 320 in rod 344 and flexible tube 322. Other suitable methods of coupling the tube flexible 322 to axis 344 will be apparent to those skilled in the art based on the teachings of the present invention. Flexible tube 322 may comprise a conventional NG (naso-gastric) tube or any other suitable structure.
    [0072] Slide feature 360 is coupled to flexible tube 322. Slide feature 360 comprises a slide collar 368, connecting elements 367, and a cam collar 366, as shown in Figure 11. Slide collar 368 wraps around the flexible tube 322 such that slide collar 368 slides proximally and/or distally along flexible tube 322. A cam collar 366 is positioned distally to slide collar 368 and cam collar 366 is also wrapped around the flex tube 322 such that cam collar 366 slides proximally and/or distally along flexible tube 322. Cam collar 366 defines a tapered configuration. One or more connecting elements 367 extend between sliding collar 368 and cam collar 366 to connect sliding collar 368 to cam collar 366.
    [0073] The expansion feature 361 is also coupled to the flexible tube 322, as shown in Figures 13 and 14. The expansion feature 361 comprises expansion elements 362 and a washer 363. The washer 363 surrounds the flexible tube 322 so that the washer 363 is positioned between the cam collar 366 and the sliding collar 368. The washer 363 is secured relative to the flexible tube 322 so that the sliding feature 360 also slides relative to the washer 363. A plurality of expansion elements 362 extends distally from washer 363 to anvil 340. Expansion members 362 are positioned to extend from under sliding collar 368 and over cam collar 366, as shown in Figure 11. A mesh 364 is applied to the feature. of expansion members 361 to cover expansion members 362. Mesh 364 is configured to taper from anvil 340 to washer 363. Mesh 364 expands and contracts with expansion members 362. In the present example, mesh 364 extends to the underside of the anvil head 340. In some other versions, the mesh 364 completely surrounds the anvil head 340. Additionally or alternatively, the mesh 364 may completely surround the anvil shank 340.
    [0074] As shown in Figures 15 and 16, the flexible tube 322 is coupled to the anvil 340 through the shank 344, with the expansion feature 361 in a retracted state. Expansion members 362 and/or mesh 364 may be resiliently biased to assume the retracted configuration of Figures 15 and 16. In the retracted state, slider feature 360 is in the distal position so that cam collar 366 is distal to washer 363. A user holds the sliding collar 368 to move the sliding collar 360 to a proximal position, as shown in Figures 13 and 14. A conventional gripper or any other device can be used to translate the sliding collar 368. 368 proximally translated, cam collar 366 also proximally translated to engage washer 363. The tapered configuration of cam collar 366 below expansion members 362 acts as a cam, pushing expansion members 362 outward to an expanded state. In the expanded state, expansion members 362 contact the edge of proximal surface 350 of anvil 340. Mesh 364 also expands with expansion members 362. In the expanded state, expansion feature 361 covers the edge and pockets. of clamps 352 of anvil 340. With proximal surface 350 of anvil 340 covered by dilation feature 361, anvil 240 is introduced transorally by pulling flexible tube 322 of anvil delivery system 300 through the esophagus as shown in Figure 17A. When the dilation feature 362 is in the expanded position, the dilation feature 362 prevents the edge of the anvil 340 from dragging along the inner wall of the esophagus. Once anvil 340 is in a desired position within the esophagus, suture 380 connecting flexible tube 322 and anvil shaft 344 is cut. The sliding collar 368 is then advanced distally to allow the dilating feature 361 to retract. As shown in Figure 17B, flexible tube 322 is then pulled to remove flexible tube 322, slider feature 360, and dilation feature 361 from anvil 340. Anvil 340 is then coupled to trocar 38 of the circular surgical stapling instrument. 10 for operation. B. Exemplary anvil grip features
    An anvil 40 may comprise anvil gripping features to facilitate pulling the anvil 40 upside down through the esophagus so that the proximal side of the anvil 40 faces away from the tissue. This can allow a tapered or curved upper surface of anvil 40 to engage tissue as anvil 40 is pulled through the esophagus. Either a flexible or rigid anvil grip feature can be used. Several examples of such features will be described in more detail below, while other examples will be apparent to one skilled in the art in view of the teachings of the present invention. 1. Exemplary flexible grip feature
    [0076] Figures 18 to 19C show an exemplary anvil assembly 400 comprising an anvil grip feature 448. The grip feature 448 is used to grip the anvil 440 in an orientation with the top surface 442 leading through. a naturally occurring body lumen (eg, the esophagus). Anvil assembly 400 comprises an anvil 440, an anvil gripping feature 448, and an anvil shank 444, as shown in Figure 18. Anvil 440 is similar to anvil 40 described above. Anvil 440 comprises clip pockets 452 on the lower surface 450 of the anvil 440. The shaft 444 extends from the lower surface 450 of the anvil 440. The shaft 444 can be coupled to the trocar 38. The anvil 440 defines a tapered configuration so that it the top surface 442 comprises a smaller diameter than the bottom surface 450. The grip feature 448 extends from the top surface 442 of the anvil 440. The grip feature 448 may be flexible. As shown in Figure 18, the grip feature 448 is configured as a rounded tab. The grip feature 448 can also be configured as a long round cylindrical flap or as a flat flap-shaped flap. Other suitable gripping configurations will be apparent to one of skill in the art in view of the teachings of the present invention.
    [0077] In an example usage, as shown in Figures 19A to 19C, the anvil 440 is introduced by the advancing top surface 442 transorally across the esophagus. The tapered configuration defined by the anvil 440 provides smooth transit for the anvil 440 through the esophagus. esophagus. A suture 450 is attached around shank 444 of anvil 440. A conventional surgical gripper 460 is used to grasp the grip feature 448 with end actuating grippers 462, as shown in Figure 19A. Then, claw 460 is pulled through the esophagus to transorally introduce anvil 440 to the intended anastomotic site. Once the incus 440 is close to a desired position within the esophagus, the claw 460 releases the grip feature 448. As shown in Figure 19B, the claw 460 then captures the suture 450 to pull the anvil shaft 444 to, in this way, turn the anvil 440 to align the lower surface 450 with the fabric to be stapled. After the anvil 440 is rotated, the gripper 460 continues to pull the anvil 440 into position, as shown in Figure 19C. Suture 350 is then cut and claw 460 is removed. Anvil 440 is then coupled to trocar 38 of circular surgical stapling instrument 10 for operation. 2. Exemplary rigid grip feature
    [0078] Figures 20 through 21B show another exemplary anvil assembly 700 comprising an anvil grip feature 748. Anvil assembly 700 comprises an anvil 740 and an anvil grip feature 748, as shown in Figure 20. Anvil 740 is similar to anvil 40 described above. The anvil 740 comprises clip pockets 752 in the lower surface 750 of the anvil 740. A shank 746 extends from the top surface 742 of the anvil 740 to connect the anvil grip feature 748 to the anvil 740. The anvil grip feature 748 comprises a convex-shaped upper part. An opening 744 is formed in the lower surface 750 of the anvil 740 to receive the trocar 738, as shown in Figure 21A. Aperture 744 comprises an inwardly extending annular projection 743.
    [0079] The trocar 738 is similar to the trocar 38. The trocar 738 comprises a sharpened distal end 730, a cam portion 732, a rod 733, and expansion members 736, as shown in Figure 21A. The distal portion of the rod 733 is angled to form a cam portion 732. The sharpened distal end 730 is positioned distally to the cam portion 732. An axle 733 extends through the expansion members 736. The expansion members 736 comprise recesses extending inwardly 734 that correspond to projection 743.
    [0080] In an example usage, the anvil 740 is introduced by the advancing top surface 742 through a naturally occurring body lumen eg the esophagus. A claw is used to capture the 748 grip feature with claws to pull the 740 anvil transorally across the esophagus. Anvil 740 is rotated to align bottom surface 750 with fabric 2 to be stapled. Once the incus 740 is positioned within the esophagus, the incus 740 is coupled to the trocar 738 for operation. In particular, trocar 738 is inserted into opening 744 of incus 740 until recesses 734 align with projection 743, as shown in Figure 21A. Stem 733 is pulled proximally to slide stem 733 through expansion members 736. As stem 733 is moved proximally, cam portion 732 pushes expansion members 736 outward, as shown in Figure 21B. This causes the recesses 734 to engage the protrusion 743. The longitudinal position of the rod 733 relative to the expansion members 736 is maintained so as to cause the recesses 734 of the trocar 738 to lock the anvil 740 into the trocar 738 during operation of the circular surgical stapling instrument 10. After instrument 10 has been operated, rod 733 can be moved distally to allow expansion members 736 to bend inwardly. This removes indentations 734 from protrusion 743 to unlock incus 740 from trocar 738. Instrument 10 and incus 740 can then be removed separately from the anastomotic site. Alternatively, instrument 10 can be removed from the anastomotic site with incus 740 still attached to trocar 738. C. Exemplary Anvil Attachment Feature
    [0081] An anvil clamping feature 848 can be applied to a variety of anvils, including those described above, to hold the anvil 840 in place with respect to tissue while attaching the anvil 840 to a trocar 38. An exemplary anvil assembly 800 which comprises an anvil clamping feature 848 is shown in Figures 22A through 22B. Anvil assembly 800 comprises an anvil 840 and an anvil grip feature 820. Anvil 840 is similar to anvil 40 described above. The anvil 840 comprises pockets of staples 852 in the lower surface 850 of the anvil 840. A shank 844 extends from the lower surface 850 of the anvil 840. The clamping feature of the anvil 848 is fixedly coupled to the shank 844. Anvil 848 comprises a collar 822 and a flange 820 extending from the collar 822, as shown in Figure 22A. Collar 822 is configured to engage rod 844 to couple the anvil 848 fastening feature to anvil 840. An opening 824 is formed in flange 820 so that a suture can pass through opening 824. Alternatively, flange 820 can be formed of a pliable material to allow needle 832 to pierce flange 820 at any desired location on flange 820.
    [0082] Once the incus 840 is positioned within the esophagus, using any of the features described above, the incus 848 clamping feature allows for the retention of the incus 840 in relation to tissue after a claw is removed from the anvil 840 . As shown in Figures 22A to 22B, tissue 2 is sutured in a pocket configuration. Then, suture 830 passes through opening 824 of anvil fastening feature 848 by needle 832. A loop is formed through opening 824 around flange 820 with suture 830. As suture 830 is withdrawn from tissue 2 and flange 820, anvil 840 is held in position by suture 830. With anvil 840 secured to tissue 2, anvil 840 is held in place when anvil 840 is attached to a trocar 38. Other suitable suturing methods for securing anvil 840 , will be apparent to one skilled in the art in view of the teachings of the present invention. III. Other considerations
    [0083] It should be understood that any one or more of the teachings, expressions, modalities, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, modalities, examples, etc. which are described here. Therefore, the teachings, expressions, modalities, examples, etc. described above should not be viewed in isolation from one another. Various suitable ways in which the teachings of the present invention may be combined will be readily apparent to those skilled in the art in view of the teachings of the present invention. These modifications and variations are intended to be included within the scope of the appended claims.
    [0084] It is understood that any patent, publication, or other disclosure material, in whole or in part, which is incorporated herein by reference, is incorporated in the present invention only if the incorporated material does not enter into conflict with existing definitions, statements, or other disclosure material presented in this disclosure. Accordingly, and to the extent necessary, the description as explicitly stated herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, which is hereby incorporated by reference into the present invention, but which conflicts with existing definitions, statements, or other descriptive materials set forth herein will be incorporated herein only to the extent that no conflict. will appear between the embodied material and the existing descriptive material.
    [0085] Versions of the devices described above may have application in conventional medical treatments and procedures conducted by a medical professional, as well as application in robotic-assisted medical treatments and procedures. By way of example only, various teachings of the present invention can be readily incorporated into a robotic surgical system such as the DAVINCI™ system by Intuitive Surgical, Inc., of Sunnyvale, California, USA. Similarly, those skilled in the art will recognize that the various teachings of the present invention can be easily combined with the various teachings of US Patent No. 6,783,524 entitled "Robotic Surgical Tool with Ultrasound Cauterizing and Cutting Instrument", issued August 31 of 2004, the description of which is incorporated herein by reference.
    [0086] The versions described above may be designed to be discarded after a single use, or they may be designed to be used multiple times. Versions can, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning can include any combination of steps of disassembling the device, followed by cleaning or replacing particular parts, and subsequent reassembly. In particular, some versions of the device can be disassembled, any number of particular parts or parts of the device can be selectively replaced or removed in any combination. With cleaning and/or replacement of particular parts, some versions of the device can be reassembled for subsequent use in a reconditioning facility, or by a user immediately prior to a surgical procedure. Those skilled in the art will understand that reconditioning a device can utilize a variety of techniques for disassembly, cleaning/replacement and reassembly. The use of such techniques and the resulting refurbished device are all within the scope of this order.
    [0087] By way of example only, the versions described here can be sterilized before and/or after a procedure. In a sterilization technique, the device is placed in a closed, sealed container such as a plastic or TYVEK bag. The container and device can then be placed in a radiation field, such as gamma radiation, X-rays or high energy electrons, which can penetrate the container. Radiation can kill bacteria in the device and container. The sterilized device can then be stored in a sterile container for later use. The device may also be sterilized using any other known technique, including, but not limited to, beta or gamma radiation, ethylene oxide, or water vapor.
    [0088] Having shown and described various embodiments of the present invention, other adaptations of the methods and systems described in the present invention can be carried out by means of suitable modifications by a person skilled in the art without departing from the scope of the present invention. Several of these possible modifications have been mentioned, and others will be evident to those skilled in the art. For example, the examples, modalities, geometry, materials, dimensions, proportions, steps and the like discussed above are illustrative and not necessary. Accordingly, the scope of the present invention is to be considered in accordance with the terms of the following claims and it is understood that it is not limited to the details of structure and operation shown and described in the specification and drawings.
    权利要求:
    Claims (11)
    [0001]
    1. Apparatus for stapling tissue, the apparatus comprising: (a) an anvil (240; 340), wherein the anvil comprises: (i) a distal surface, (ii) a proximal surface (250; 350), and (iii) ) a plurality of staple pockets (252; 352), wherein the plurality of staple pockets are formed on the proximal surface (250; 350) of the anvil (240; 340); wherein the anvil (240; 340) is configured to be inserted through a body lumen; and (b) an anvil introducing system (200; 300) coupled to the anvil (240; 340), wherein the anvil introducing system (200; 300) comprises an expansion feature, wherein the expansion feature is configured to transition between: (i) a collapsed state, and (ii) an expanded state, wherein the expansion feature covers the clamp pockets (252; 352) of the anvil (240; 340) in the expanded state; wherein the dilation feature is configured to be in the expanded state when the anvil (240; 340) is inserted through the body lumen; characterized by the fact that: (i) the dilation feature comprises a bladder (210); or, (ii) the expansion feature comprises a plurality of expandable members (362) and a mesh wrapped around the plurality of expandable members (362), and the anvil introduction system (300) further comprises a sliding feature (360). ), wherein the slider feature (360) is operable to transition the dilation feature from the collapsed state to the expanded state in response to the translation of the slider feature (360).
    [0002]
    2. Apparatus according to claim 1, characterized in that the anvil (240; 340) is configured to be inserted orally.
    [0003]
    3. Apparatus according to claim 1, characterized in that the anvil introduction system (200; 300) is detachably coupled to the anvil (240; 340).
    [0004]
    4. Apparatus according to claim 1, characterized in that the anvil (240; 340) further comprises a shaft (244; 344).
    [0005]
    5. Apparatus according to claim 4, characterized in that it further comprises an anvil clamping feature (848) coupled to the anvil shaft (244; 344) (240; 340), wherein the anvil clamping feature anvil (848) is operable to secure the anvil (240; 340) to the body lumen.
    [0006]
    6. Apparatus according to claim 5, characterized in that the anvil fastening feature (848) comprises a collar (822) wrapped around at least a portion of the shaft (244; 344) of the anvil (240 ;340) and a flange (820) protruding from the collar (822).
    [0007]
    7. Apparatus according to claim 4, characterized in that the anvil introduction system (200; 300) further comprises a tube (222; 322) coupled to the anvil shaft (244; 344), wherein the tube (222; 322) is configured to pull the anvil (240; 340) through the body lumen.
    [0008]
    8. Apparatus according to claim 1, characterized in that the dilation feature defines a conical configuration.
    [0009]
    9. Apparatus according to claim 1, characterized in that the bladder (210) is configured to receive a fluid to transition the bladder (210) from the collapsed state to the expanded state.
    [0010]
    10. Apparatus according to claim 9, characterized in that the fluid is air or saline solution.
    [0011]
    11. Apparatus according to claim 1, characterized in that the sliding feature (360) comprises a sliding collar (368), a cam collar (366) positioned distally to the sliding collar (368) and at least one member connection (367) coupling the sliding collar (368) to the cam collar (366).
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    BR112014016620B1|2021-10-26|SURGICAL STAPLER
    同族专利:
    公开号 | 公开日
    IN2015DN03982A|2015-10-02|
    CN104837415A|2015-08-12|
    US9572573B2|2017-02-21|
    CN104837415B|2017-09-12|
    JP6373859B2|2018-08-15|
    RU2655117C2|2018-05-23|
    WO2014089197A1|2014-06-12|
    BR112015013062A2|2017-07-11|
    JP2015536224A|2015-12-21|
    MX357428B|2018-07-09|
    US20160324525A1|2016-11-10|
    RU2015126850A|2017-01-11|
    US20140151429A1|2014-06-05|
    MX2015007040A|2015-09-28|
    EP2928387A1|2015-10-14|
    US10743866B2|2020-08-18|
    EP2928387B1|2017-11-22|
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    法律状态:
    2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-12-17| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-06-29| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-08-31| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 04/12/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US13/693,430|2012-12-04|
    US13/693,430|US9572573B2|2012-12-04|2012-12-04|Trans-oral circular anvil introduction system with dilation feature|
    PCT/US2013/073097|WO2014089197A1|2012-12-04|2013-12-04|Trans-oral circular anvil introduction system with dilation feature|
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