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    • 专利摘要:
    SET OF SURGICAL CLAMPS WITH HEMOSTATIC RESOURCE. The present invention relates to a surgical instrument including a handle portion, a rod housing a trigger bar, an end actuator comprising an anvil, a lower jaw, and a clamping and separating assembly responsive to a movement of longitudinal closure produced by the cable portion and the rod. The lower jaw is configured to receive a removable cartridge. The cartridge includes a housing, a plurality of clips disposed in the housing, a holder disposed on the plurality of clips, and a fastener insert tip including a plurality of clips. The bracket defines the opening, with each opening being substantially disposed in each clip. The instrument includes a clamping insert which includes hooks, and the clamping insert is removably received on the anvil. A buttress is attached to one or both of the anvil and cartridge via hooks.
    公开号:BR112014007021B1
    申请号:R112014007021-0
    申请日:2012-09-19
    公开日:2021-05-04
    发明作者:Yi-Lan Wang；Matthew C. Miller；Aron O. Zingman
    申请人:Ethicon Endo-Surgery, Inc；
    IPC主号:
    专利说明:

    BACKGROUND
    [001] In some contexts, endoscopic surgical instruments may be preferred over devices for traditional open surgery, as a smaller incision can reduce recovery time and complications in the postoperative period. Consequently, some endoscopic surgical instruments may be suitable for placing a distal end actuator at a desired surgical site via the cannula of a trocar. These distal end actuators can secure tissue in a variety of ways to achieve a diagnostic or therapeutic effect (eg, endocutter, gripper, cutter, stapler, clip applicator, access device, drug delivery device/gene therapy device, and device for application of energy using ultrasound, RF, laser, etc.). Endoscopic surgical instruments may comprise a rod between the end actuator and a handle portion, which is manipulated by the physician. This rod can allow insertion to the desired depth and rotation around the longitudinal axis of the rod itself, thus facilitating the positioning of the end actuator on the patient. Positioning an end actuator can also be facilitated by the inclusion of one or more swivel joints or features, allowing the end actuator to be selectively swiveled or even offset with respect to the longitudinal axis of the stem.
    [002] Examples of endoscopic surgical instruments include surgical staplers. Some of these staplers can be operated to staple fabric layers, cut through stapled fabric layers, and push the staples through fabric layers to securely join the separate fabric layers close to the separated ends of the fabric layers. Merely exemplary surgical staplers are revealed; US Patent No. 4,805,823 entitled "Pocket Configuration for Internal Organ Staplers", issued February 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. 6,964,363 entitled "Surgical Stapling Instrument having Articulation Joint Support Plates for Supporting a Firing Bar", granted on November 15, 2005; US Patent No. 6,978,921 entitled "Surgical Stapling Instrument Incorporating an E-Beam Firing Mechanism", issued December 27, 2005; US Patent No. 6,988,649 entitled "Surgical Stapling Instrument Having a Spent Cartridge Lockout", issued January 24, 2006; U.S. Patent No. 7,000,818 entitled "Surgical Stapling Instrument Having Separate Distinct Closing and Firing Systems", issued February 21, 2006; US Patent No. 7,111,769 entitled "Surgical Instrument Incorporating an Articulation Mechanism having Rotation about the Longitudinal Axis", issued September 26, 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; US Patent No. 7,721,930 entitled "Disposable Cartridge with Adhesive for Use with a Stapling Device", issued May 25, 2010; and US Patent No. 7,455,208 entitled "Surgical Instrument with Articulating Shaft with Rigid Firing Bar Supports", issued November 25, 2008. The description of each of the above-cited US patents is incorporated by reference into the present invention. 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.
    [003] Although various types of surgical stapling instruments and associated components have been manufactured and used, it is believed that no one prior to the inventor(s) has manufactured or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS
    [004] The attached drawings, which are incorporated into and form part of this descriptive report, illustrate embodiments of the invention and, together with the general description provided above and the detailed description of the embodiments provided below, serve to explain the principles of present invention.
    [005] FIG. 1A is a perspective view of an articulated surgical instrument with an end actuator in an unhinged position;
    [006] FIG. 1B is a perspective view of the surgical instrument of FIG. 1A with one end actuator in pivoted position;
    [007] FIG. 2 is a perspective view of the open-end actuator of the surgical instrument of FIGS. 1A and 1B;
    [008] FIG. 3A is a side cross-sectional view of the end actuator of FIG. 2, taken along line 3-3 of FIG. 2, with the trigger bar in a proximal position;
    [009] FIG. 3B is a side cross-sectional view of the end actuator of FIG. 2, taken along line 3-3 of FIG. 2, but showing the trigger bar in a distal position;
    [010] FIG. 4 is an end cross-sectional view of the end actuator of FIG. 2, taken along line 4-4 of FIG. two;
    [011] FIG. 5 is an exploded perspective view of the end actuator of FIG. two;
    [012] FIG. 6 is a perspective view of the end actuator of FIG. 2, positioned on the fabric and being actuated once on the fabric;
    [013] FIG. 7 is a fragmentary perspective view of an anvil version of the end actuator of FIG. 2, and a gripper insert configured for receipt at the anvil opening;
    [014] FIG. 8 is a fragmentary perspective view of a cartridge version of the end actuator of FIG. two;
    [015] FIG. 9 is a partial side elevation view of a version of the end actuator of FIG. 2 including the anvil of FIG. 7 and the cartridge of FIG. 8, and a support attached to the end actuator; and
    [016] FIG. 10 is a perspective view of an end actuator with a cradle attached, the end actuator being positioned and actuated on tissue to release a tissue repair composition from cradle on the tissue.
    [017] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily represented in the drawings. The accompanying drawings incorporated and forming a part of the descriptive report illustrate various aspects of the present invention, and together with the description serve to explain the principles of the invention; it is understood, however, that this invention is not limited to the arrangements shown. DETAILED DESCRIPTION
    [018] The following description of specific examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, modalities and advantages of the invention will become apparent to those skilled in the art from the following description, which uses illustrations, one of the best contemplated modes for carrying out the invention. As will be understood, the invention may have other different and obvious aspects, all without departing from the invention. Consequently, the drawings and descriptions are to be regarded as illustrative in nature and not restrictive. Exemplary surgical stapler
    [019] FIGS. 1-6 depict an exemplary surgical stapling and separating instrument (10) that is sized for insertion in a non-articulated state, as depicted in FIG. 1A, through the passage of a trocar cannula to a surgical site in a patient undergoing a surgical procedure. The surgical stapling and separating instrument (10) includes a handle portion (20) connected to an implementation portion (22), the latter further comprising a rod (23) terminating distally in a hinge mechanism (11) and a distally attached end actuator (12). When the pivot mechanism (11) and end actuator (12) are inserted through a passage of the cannula of a trocar, the pivot mechanism (11) can be remotely pivoted as shown in FIG. 1B, by the articulation control (13). Thus, the end actuator (12) can reach behind an organ or approach tissue at a desired angle or for other reasons. It should be understood that terms such as "proximal" and "distal" are used in the present invention with reference to the handle portion (20) of the instrument (10) manipulated by the physician. In this way, the end actuator (12) is distal with respect to the most proximal cable portion (20). It will further be recognized that, for convenience and clarity, spatial terms such as "vertical" and "horizontal" are used in the present invention in relation to the drawings. However, surgical instruments can be used in many orientations and positions, and these terms are not intended to be limiting and absolute.
    [020] End actuator (12) of the present example includes a lower jaw (16) and a hinged anvil (18). The handle portion (20) includes a pistol grip (24), against which a closing trigger (26) is pivotally pressed by the physician in order to pinch or close the anvil (18) against the lower jaw ( 16) of the end actuator (12). This closing of the anvil (18) is achieved by means of an external closing sleeve (32), which translates longitudinally with respect to the handle portion (20) in response to the articulated actuation of the closing trigger (26) against the handle of pistol (24). A distal closure ring (33) of the closure sleeve (32) is indirectly supported by the frame (34) of the implement portion (22). In the hinge mechanism (11), a proximal closure tube (35) of the closure sleeve (32) communicates with the distal closure ring (33). The frame (34) is flexibly connected to the lower jaw (16) via the articulation mechanism (11), allowing articulation in a single plane. The frame (34) also longitudinally and slidingly supports a firing guiding member (not shown), which extends through the rod (23) and transmits firing motion from the firing trigger (28) to the firing bar. shot (14). The firing trigger (28) is furthest away from the closing trigger (26), being pivotally pressed by the physician to staple and separate the tissue clamped on the end actuator (12), as will be described in more detail below. Then, the release button (30) is released to release the tissue from the end actuator (12).
    [021] FIGS. 2 to 5 depict the end actuator (12) employing an E-beam trigger bar (14) to perform various functions. As best seen in FIGS. 3A and 3B, the trigger bar (14) includes a transversely oriented top pin (38), a trigger bar cap (44), a transversely oriented middle pin (46) and a distally oriented cutting edge (48). The top pin (38) is located and is translatable within an anvil pocket (40) of the anvil (18). The trigger bar cap (44) slidingly engages the lower surface of the lower jaw (16), causing the trigger bar (14) to extend along the slot of the channel (45) (shown in FIG. 3B) which is formed along the lower jaw (16). The middle pin (46) slidingly engages the top surface of the lower jaw (16), cooperating with the trigger bar cap (44). In this way, the firing bar (14) affirmatively spaces the end actuator (12) during firing, avoiding mechanical pinching that can occur between the anvil (18) and the lower jaw (16) with a minimal amount of pinched tissue and preventing bad staple formation when an excessive amount of tissue is clamped.
    [022] FIG. 2 shows the trigger bar (14) positioned proximally and the anvil (18) hinged in an open position, allowing a non-biased staple cartridge (37) to be removably installed in the lower jaw channel (16). As best seen in FIGS. 4 and 5, the staple cartridge (37) of this example includes the cartridge body (70), which contains an upper platform (72), and is coupled to a lower cartridge tray (74). As best seen in FIG. 2, a vertical slit (49) is formed through part of the staple cartridge (37). Furthermore, as is best seen in FIG. 2, three rows of staple openings (51) are formed through the upper platform (72) on one side of the vertical slot (49), with another set of three rows of staple openings (51) formed through the upper platform (72). ) on the other side of the vertical slot (49). Returning to FIGS. 3-5, a wedge-shaped slider support (41) and a plurality of clamp drivers (43) are captured between the cartridge body (70) and the tray (74), with the wedge-shaped slider support ( 41) located proximal to the staple drivers (43). The wedge-shaped slide holder (41) is movable longitudinally within the staple cartridge (37); while the staple drivers (43) are movable vertically within the staple cartridge (37). The staples (47) are also positioned within the cartridge body (70), above the corresponding staple drivers (43). In particular, each clamp (47) is urged vertically into the cartridge body (70) by a staple driver (43) so as to urge the clamp (47) through an associated clamp opening (51). As best seen in FIGS. 3A and 3B and 5, the wedge-shaped slider support (41) has slanted cam surfaces that push the staple drivers (43) upward as the wedge slider support (41) is pushed distally through the cartridge. of staples (37).
    [023] With the end actuator (12) closed, as shown in FIG. 3A, the trigger bar (14) is advanced in engagement with the anvil (18) by entering the top pin (38) into a longitudinal slot of the anvil (42). A drive block (80) is located at the distal end of the trigger bar (14) and is configured to engage the wedge slide support (41) so that the wedge slide support (41) is pushed. distally by the drive block (80) as the trigger bar (14) is advanced distally through a staple cartridge (37). During this firing, the cutting edge (48) of the firing bar (14) enters the vertical slot (49) of the staple cartridge (37), separating the clamped tissue between the staple cartridge (37) and the anvil (18) . As shown in FIGS. 3A-3B, the middle pin (46) and the drive block (80) together drive the staple cartridge (37) into a firing slot (49) within the staple cartridge (37), which drives the wedge-shaped sliding support (41) into upward cam contact with the clamp drivers (43) which, in turn, drive the clamps (47) through the clamp openings (51) and into the forming contact with the staple forming cavities (53) on the inner surface of the anvil (18). FIG. 3B depicts the trigger bar (14) completely distally translated after tissue separation and stapling is complete.
    [024] FIG. 6 shows an end actuator (12) that has been actuated by a single stroke through fabric (90). The cutting edge (48) cuts through the fabric (90), while the staple drivers (43) drive three alternating rows of staples (47) through the fabric (90) on each side of the cut line produced by the cutting edge (48 ). The clamps (47) are all oriented substantially parallel to the cut line in this example, although it should be understood that the clamps (47) can be positioned in any suitable orientations. In the present example, the end actuator (12) is removed from the trocar after the first stroke is completed, the staple cartridge sent (37) is replaced with a new staple cartridge, and the end actuator (12) is again inserted through the trocar to reach the stapling site for additional cutting and stapling. This process can be repeated until the desired amount of cuts and staples (47) has been applied. The incus (18) may need to be closed to facilitate insertion and removal through the trocar; and the anvil (18) may need to be opened to facilitate replacement of the staple cartridge (37).
    [025] It should be understood that the cutting edge (48) can separate tissue substantially at the same time as the clamps (47) are pushed through the tissue during each stroke of actuation. In the present example, the cutting edge (48) closely follows the insertion of the staples (47), so that a staple (47) is pushed through the tissue just before the cutting edge (48) passes through the same region of the tissue, although it should be understood that this order can be reversed, or that the cutting edge (48) can be directly synchronized with the adjacent clamps. Although FIG. 6 show the end actuator (12) being actuated in two layers (92, 94) of fabric (90), it should be understood that the end actuator (12) can be actuated through a single layer of fabric (90) or more than two layers (92, 94) of fabric. It should also be understood that the formation and positioning of the clips (47) adjacent to the cut line produced by the cutting edge (48) can substantially join the tissue at the cut line, thus reducing or preventing bleeding and/or leakage of other bodily fluids in the cut line. Various suitable configurations and procedures in which instrument 10 can be used will be apparent to those skilled in the art in view of the teachings contained herein.
    [026] It should be understood that the instrument (10) is configurable and operable in accordance with any other teachings of US Patent No. 4,805,823; US Patent No. 5,415,334; US Patent No. 5,465,895; US Patent No. 5,597,107; US Patent No. 5,632,432; US Patent No. 5,673,840; US Patent No. 5,704,534; US Patent No. 5,814,055; US Patent No. 6,978,921; US Patent No. 7,000,818; US Patent No. 7,143,923; US Patent No. 7,303,108; US Patent No. 7,367,485; US Patent No. 7,380,695; US Patent No. 7,380,696; US Patent No. 7,404,508; US Patent No. 7,434,715; and/or US patent No. 7,721,930
    [027] As noted above, the descriptions of each of these patents are incorporated by reference to the present invention. Additional exemplary modifications that can be made to the instrument (10) will be described in more detail below. Various suitable ways in which the teachings below can be incorporated into instrument (10) will be apparent to those skilled in the art. Similarly, various ways in which the teachings below can be combined with the various teachings of the patents cited herein will be apparent to those skilled in the art. It is also to be understood that the teachings below are not limited to the instrument (10) or devices taught in the patents cited herein. The teachings below can be readily applied to many other types of instruments, including instruments that would not be classified as surgical staplers. Various other suitable devices and configurations in which the teachings below can be applied will be apparent to those skilled in the art in view of the teachings contained herein. Alternative anvil and cartridge with exemplifying support
    [028] FIGS. 7-10 show an exemplary reciprocating end actuator (121) that includes an anvil (99) and a cartridge (101), each of which can be coupled to an exemplary mount (142). The end actuator (121) is similar to the end actuator (12) described above, except as shown below. The anvil (99) is similar to the anvil (18) described above, except as shown below. Additionally, the cartridge (101) is similar to the cartridge (101) described above, except as shown below. In this way, the anvil (99) and cartridge (101) can be driven using an instrument (10), in a manner similar to that described with respect to driving the anvil (18) and cartridge (37). Exemplary anvil clamping insert
    [029] FIG. 7 shows an anvil (99) configured to receive a clamping insert (100) in the direction of arrow (A). Particularly, the anvil (99) includes an opening (102) at the distal end (103) of an anvil slit (42). The opening (102) is configured to receive and secure the clamping insert (100). The opening (102) includes an upper portion (104) and a lower portion (106), which are disposed below and narrower in width than the upper portion (104). The upper portion (104) is defined by an inner top surface (108) of the anvil (99), the opposing protrusion surfaces (110), and the first inner sidewall (112) positioned therebetween. The lower portion (106) is defined by secondary inner side walls (114) projecting from the protrusion surfaces below (110), and rear wall (116) disposed between the secondary inner side walls (114).
    [030] Fastener insert (100) includes a top surface (118), a distal wall (120), and a proximal wall (122). The proximal wall (122) is first received in the opening (102) in the direction of arrow (A). Both the distal wall (120) and the proximal wall (122) include oppositely positioned upper and lower portions. The first longitudinal walls (124) are positioned between the upper portions of the distal wall (120) and the proximal wall (122). The secondary longitudinal walls (126) are positioned between the lower portions of the distal wall (120) and the proximal wall (122). The transverse walls (128) are positioned between the ends of the first and second longitudinal walls (124, 126) to define a demarcation area between the upper and lower portions of the distal wall (120) and proximal wall (122). The base surface (130) is disposed between the lower ends of the secondary longitudinal walls (126) and is separated from the top surface (118) by the distal wall (120) and the proximal wall (122). Hooks (132) project downwardly from the base surface (130) in a direction substantially perpendicular to the base surface (130).
    [031] fastener insert (100) may comprise a molded unitary part inserted into the opening (102) at a manufacturing site, a surgical site, or elsewhere. When the fastener insert (100) is received in the opening (102), the top surface (118) of the fastener insert (100) is configured to be in a position abutting the inner top surface (108) of the opening (102). The first longitudinal walls (124) of the fastener insert (100) are configured to be received by the side support as opposed to the first inner side walls (112) of the upper portion (104) of the opening (102). The transverse walls (128) of the fastener insert (100) are configured to be received by the side support against the protrusion surfaces (110) of the upper portion (104) of the opening (102). At the same time, secondary longitudinal walls (126) of the fastener insert (100) are configured to be slidably received in a boundary position opposite the secondary side walls (114) of the lower portion (106) until the proximal wall (122) of the fastener insert (100) abuts against the rear wall (116) of the opening (102).
    [032] When the fastener insert (100) is received into the opening 102), as described above, hooks (132) are automatically positioned so that in use, further described below, they can hook into loop-type formations on a fixed support (142) without causing trauma to the tissue on which the backing material will be deposited. In particular, hooks (132), and hooks (140, 148) described below, will only connect to the small fibers that form the loop-like formations within a fixed support (142) and not to any clamped fabric (90). B. Lower jaw sample cartridges
    [033] FIG. 8 shows a version of a removable cartridge (101) manufactured with a fastener insert (134) so that the fastener insert (134) is molded as a tip to the distal end (136) of the removable cartridge (101) prior to use in one place. surgical. The gripper insert (134) includes a top surface (138) for facing toward the anvil (99) when the cartridge (101) is received within the lower jaw (16). The hooks (140) protrude from the top surface (138) of the fastener insert (134) in a direction substantially perpendicular to the top surface (138). Similar to hooks (132), hooks (140) connect (to the small fibers that form the loop-like formations within a fixed support (142) and not to any fabric (90) stapled by an end actuator (121). C. End Actuator and Exemplary Belt Mount
    [034] As shown in FIG. 9, the bearing (142) of the present example includes an anvil portion (144) and a cartridge portion (146) for attaching to the anvil (99) and the cartridge (101) respectively. The anvil portion (144) and cartridge portion (146) may alternatively form two separate bearings instead of a single bearing (142). With a single mount (142), the cartridge (101) may additionally include hooks (148) on a proximal portion of the cartridge (101) to provide additional mechanical attachment of the mount (142) to the end actuator (121). Similar to hooks (132, 140), hooks (148) connect (to the small fibers that form the loop-like formations within a fixed support (142) and not to any staples (90). FIG. 9 shows the support (142) attached to both the anvil (99) and the cartridge (101). Alternatively, the support (142) can only attach to the anvil (99) or the cartridge (101).
    [035] In use, as shown in FIG. 9, the support (142) can be secured to the anvil (99) through the hooks (132) described above in relation to the fastener insert (100). The support (142) is secured at an opposite end to the hooks (140) of the fastener insert (136) described above with respect to the cartridge (101). The support (142) is also secured to hooks (148) at a proximal portion (150) intermediate the respective proximal ends (152, 154) of the anvil (99) and the cartridge (101). The attachment between the support (142) and the hooks (132, 140, 148) is a hook-and-loop fastening or fastening. That is, the hooks (132, 140, 148) attach to loop-like formations in the material comprising the support (142). Other types of apparent attachment to those skilled in the art in view of the teachings in the present application are within the scope of this disclosure.
    [036] The hooks (132, 140, 148) act as detent features to hold the support (142) firmly against the anvil (99) and cartridge (101) when the fire bar (14) is driven through. of the support (142) to release the support portions (142) onto the fabric (90) as described below. When the clamps (47) are inserted toward the anvil (99) and through the support (142), the clamps (47) will provide sufficient force to remove a substantial amount of support (142) from the end actuator (121) and substantially evenly distributing the removed amount of backing material around a separate and stapled area of fabric (90). Without the retaining aspect provided by the hooks (132, 140, 148), the amount of material removed may otherwise be less evenly distributed. Additionally, unremoved backing material on one side of the end actuator (12), such as the anvil side (99), may be more likely to adhere to unremoved backing material on the other side, such as the side of the anvil (99). cartridge (101), if force is not provided through the hooks (132, 140, 148) to hold the backing material to the respective sides of the end actuator (121) before the end actuator (121) is stapled onto the fabric ( 90).
    [037] The firing bar (14) can be fired through the anvil slot (42) as described above to slice through the bearing (142) and release from the bearing (142) onto the fabric (90) when the anvil (99) staples the layers (92, 94) of fabric (90) together with the lower jaw (161) of the end actuator (121). Simultaneously, as described above, the clips (47) of the cartridge (101) can be inserted upwardly towards the clip pockets on the anvil (99) and through the support (142) to be formed in the clips that secure and secure the layers (92, 94) of tissue (90) to each other to prevent further blood loss from cutting and stapling the tissue (90).
    [038] Thus, when the surgical clip (47) is inserted into (90) tissue by a surgical instrument, such as by the instrument (10) in the manner shown above, the surgical clip (47) will compress, connect and support this tissue as shown in FIG. 10. The abutment material (142) will contact the compacted tissue and be released over the tissue to aid tissue repair by reducing the volume of bleeding at the surgical site. The support (142) can be composed of a material including, for example, a hemostatic agent to aid in blood clotting and reduce bleeding at the separate surgical site and/or stapled along the tissue (90). Additionally or as an alternative, backing (142) may comprise a biodegradable polymer that is operable to aid tissue repair as described below. Also in addition or as an alternative, the backing material (142) can provide reinforcement to the integrity of the mechanical fixation of tissue (90) by staples (47). The surgical clip (47) may comprise a material selected from iron, nickel-titanium alloy, stainless steel and/or titanium. Of course, any other material can be used. D. Exemplifier support
    [039] support (142) may comprise a fibrous dressing, a foam (e.g., open or closed cell), a matrix, a mesh or other structure, in accordance with the teachings, by way of example, of the publication of the application for US Patent No. 2009/0120994 entitled "Surgical Fastening Device with Initiator Impregnation of a Matrix or Buttress to Improve Adhesive Application", published May 14, 2009, the disclosure of which is incorporated herein by reference. The material can include porosities that induce capillary absorption upon addition of adhesive to the material and ensure that the openings remain free of adhesive allowing tissue growth through the material. openings after application to tissue. Other suitable structures that can be used to form the support (142) will be apparent to those skilled in the art in view of the teachings of the present invention.
    [040] material that forms the support (142) can comprise, for example, auxiliary compounds or hemostatic agents such as fibrin or thrombin that help in blood clotting and reduce the volume of bleeding at the surgical site. The hemostatic capabilities of these auxiliary compounds may also contribute to the use of these auxiliary compounds as adhesives and sealants. Agents can help to clot blood at the surgical site, which allows tissue surrounding the blood to remain together and can prevent leakage along the stapled tissue site, for example.
    [041] Auxiliary compounds or reagents may additionally include, but are not limited to, medicinal fluids and/or supporting components such as platelet-poor plasma (PPP), platelet-rich plasma (PRP), starch, chitosan, alginate, fibrin , polysaccharide, cellulose, bovine collagen, gelatin-resorcin-formalin adhesive, oxidized cellulose, mussel-based adhesive, poly(amino acid), agarose, amylose, hyaluronan, polyhydroxybutyrate (PHB), hyaluronic acid, poly(vinylpyrrolidone) ( PVP), poly(vinyl alcohol) (PVA), polylactide (PLA), polyglycolate (PGA), polycaprolactone (PCL), and their copolymers, VICRYL® (Ethicon, Inc., Somerville, NJ, USA), MONOCRYL material, PANACRYL (Ethicon, Inc., Somerville, NJ, USA), and/or any other material suitable to be mixed with biological material and introduced into a wound or problem site, including combinations of materials. Additional exemplary materials include are natural or genetically modified absorbable polymers or synthetic absorbable polymers, or mixtures thereof. Examples of natural or genetically modified polymers are proteins, polysaccharides and combinations thereof. Proteins include prothrombin, thrombin, fibrinogen, fibrin, fibronectin, heparinase, factor X/Xa, factor VII/VIla, factor IX/IXa, factor XI/XIa, factor XII/XIIa, tissue factor, batroxobin, ancrod, ecarine, factor of von Willebrand, collagen, elastin, albumin, gelatin, platelet surface glycoproteins, vasopressin and vasopressin analogues, epinephrine, selectin, procoagulant poison, plasminogen activator inhibitor, platelet activating agents, peptides that have hemostatic activity, and/or combination thereof. Polysaccharides include, but are not limited to, cellulose, alkyl cellulose, for example, methyl cellulose, alkyl hydroxy alkyl cellulose, hydroxy alkyl cellulose, cellulose sulfate, carboxy methyl cellulose salts, carboxy methyl cellulose, carboxy ethyl cellulose, chitin, carboxy methyl chitin, hyaluronic acid, hyaluronic acid salts, alginate, alginic acid, propylene glycol alginate, glycogen, dextran, dextran sulfate, curdlan, pectin, pullulan, xanthan, chondroitin, chondroitin sulfates, carboxy methyl dextran, carboxy methyl chitans chitosan, heparin, heparin sulfate, heparan, heparan sulfate, dermatan sulfate, keratan sulfate, carrageenans, chitosan, starch, amylose, amylopectin, poly-N-glucosamine, polymanuronic acid, polyglucuronic acid, polyguluronic acid, and derivatives of any of these. Examples of synthetic absorbable polymers are aliphatic polyester polymers, copolymers, and/or combinations thereof. Aliphatic polyesters are typically synthesized in a ring opening polymerization of monomers that include, but are not limited to, lactic acid, lactide (L-, D-, meso and mixtures of D and L), glycolic acid, glycolide, ε - caprolactone, p-dioxanone (1,4-dioxan-2-one) and trimethylene carbonate (1,3-dioxan-2-one).
    [042] In some versions, the support (142) may comprise a biocompatible carrier to contain a medical fluid. Suitable vehicles can include, for example, a physiological buffer solution, a high-flow gel solution, saline solution, and water. In the case of gel solutions, the tissue repair composition can be in a high-flow gel form prior to delivery to the target site, or it can form a gel and remain in place after delivery to the target site. High flow gel solutions can comprise one or more gelling materials with or without the addition of water, saline, or physiological buffer solution. Suitable gelling materials include biological and synthetic materials. Exemplary gelling materials include proteins, polysaccharides, polynucleotides, and other materials such as alginate, cross-linked alginate, poly(N-isopropyl acrylamide), poly(oxyalkylene), poly(ethylene oxide)-poly(propylene oxide), poly( vinyl alcohol), polyacrylate, or monostearoyl glycerol co-succinate/polyethylene glycol (MGSA/PEG) copolymers, and combinations of any of the aforementioned.
    [043] FIG. 10 shows an example of using an end actuator (12) to apply exemplary support (142), described herein, onto fabric (90) to deposit support portions (142) as a fabric repair composition onto fabric ( 90). After such application, as described above, the back (142) deposited on the fabric (90) may substantially surround and/or coat the clips (47) that secure the layers (92, 94) of fabric (90).
    [044] 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. The teachings, expressions, modalities, examples, etc. described below 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.
    [045] 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 medical treatments and procedures assisted by robotics.
    [046] Versions of the 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, in 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.
    [047] Just as an example, 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.
    [048] In view of the presentation and description of various versions in this disclosure, additional adaptations of the methods and systems described in this document can be made through suitable modifications made by an expert 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, versions, geometry, materials, dimensions, proportions, steps and the like discussed above are illustrative only and are not required. 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. A surgical instrument apparatus (10), comprising: (a) a handle portion (20); (b) a rod (23) housing a firing bar (14); (c) an end actuator (121) comprising an anvil (99), a lower jaw (161), and a clamping and separating assembly responsive to a longitudinal closing movement produced by the handle portion (20) and the rod (23); (d) a removable cartridge (101), the lower jaw (161) being configured to receive the cartridge (101) when the end actuator (121) is in an open position, the cartridge (101) comprising: (i) a housing, (ii) a plurality of clamps disposed in the housing, and (iii) a platform disposed in the plurality of clamps, the platform defining openings, each opening being disposed in each clamp; and characterized by (e) a removable fastener insert (100) comprising fasteners (132), wherein the fastener insert (100) is configured to be received on the anvil (99), and wherein the fasteners (132) are atraumatic and configured to attach to a biocompatible backing material (142) having a tissue-facing side and an anvil-facing side, and wherein the fasteners (132) are configured to attach to the anvil-facing side of the material. support (142) without extending through the support material (142).
    [0002]
    2. Apparatus according to claim 1, characterized in that the support material (142) is selected from the group consisting of at least one of the following materials: epsilon-caprolactone, glycolide, bovine pericardium, polylactic acid, polyglycolic acid, polyglactin, polydioxanone, polyglyconate, whey protein, cellulose gum, starch, gelatin, silk, nylon, polypropylene, woven polyester, polybutester, polyethylene, and polyetheretherketones.
    [0003]
    3. Apparatus according to claim 1, characterized in that the support material (142) comprises one of fibirin or thrombin.
    [0004]
    4. Apparatus according to claim 1, characterized in that the support material (142) comprises at least one of a hemostatic agent, a sealant, or an adhesive.
    [0005]
    5. Apparatus according to claim 1, characterized in that the fasteners (132) comprise hooks.
    [0006]
    6. Apparatus according to claim 5, characterized in that the hooks are configured to attach to loop formations on a backing material (142) to retain the backing material (142) on the anvil (99).
    [0007]
    7. Apparatus according to claim 1, characterized in that the cartridge (101) comprises a fastener insert at a distal end, wherein the fastener insert comprises fasteners (140).
    [0008]
    8. Apparatus according to claim 7, characterized in that the fasteners (140) are configured to attach to a biocompatible backing material (142) having a tissue-facing side and a cartridge-facing side, and wherein the fasteners (140) are configured to attach to the side facing the bearing material cartridge (142) without extending through the bearing material (142) to retain the bearing material (142) to the cartridge (101 ).
    [0009]
    9. Apparatus according to claim 7, characterized in that the fasteners (140) comprise hooks that are configured to attach to loop formations on a backing material (142) to retain the backing material (142) to the cartridge (101).
    [0010]
    10. Apparatus according to claim 1, characterized in that the proximal end of the cartridge (101) comprises fasteners (148).
    [0011]
    11. Apparatus according to claim 10, characterized in that the fasteners (148) comprise hooks that are configured to attach to loop formations in a biocompatible backing material (142) having a tissue-facing side and a cartridge-facing side, and wherein the fasteners (148) are configured to attach to the cartridge-facing side of the backing material (142) without extending through the backing material (142) to retain the backing material. (142) to the cartridge (101)
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    同族专利:
    公开号 | 公开日
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    法律状态:
    2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-11-19| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-11-24| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|
    2021-03-23| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-05-04| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 19/09/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US13/240,074|US9393018B2|2011-09-22|2011-09-22|Surgical staple assembly with hemostatic feature|
    US13/240,074|2011-09-22|
    PCT/US2012/056033|WO2013043674A1|2011-09-22|2012-09-19|Surgical staple assembly with hemostatic feature|
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