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    • 专利摘要:
    DEVICE FOR THE APPLICATION OF AUXILIARY COMPOUND IN ENDOSCOPIC PROCEDURE. The present invention relates to a modular end actuator that applies a therapeutic agent to the tissue that has been separated and / or stapled. The end actuator is removably connected to a device. The device applies force to an end actuator piston. The force causes a distal movement of the piston along a wall arranged inside the end actuator. The piston engages the agents stored on opposite sides of the wall, moving the agents distally to a mixing chamber. The agents are mixed in the mixing chamber and expelled through the tip. The staples can be inserted or arranged below a foam block, which is arranged inside a staple cartridge. By means of an endoscopic stapling device, the coated staples are pushed through the fabric while interacting with another agent in the device or the cartridge. The interaction forms the tissue repair material that is applied to the tissue.
    公开号:BR112014003068B1
    申请号:R112014003068-5
    申请日:2012-08-10
    公开日:2021-01-12
    发明作者:Brian W. Bear；Thu Anh Le；Thomas W. Lytle Iv；Mark D. Overmyer；Michael Setser；Bret W. Smith；Joseph Zavatsky；Kreena Modi
    申请人:Ethicon Endo-Surgery, Inc.；
    IPC主号:
    专利说明:

    [0001] [0001] In some contexts, endoscopic surgical instruments may be preferred over traditional open surgery devices, since 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 in a desired surgical site through the trocar cannula. These distal end actuators can hold the tissue in various ways to achieve a diagnostic or therapeutic effect (for example, cutter, claw, cutter, stapler, clamp applicator, access device, drug delivery / gene therapy device and device for application of energy using ultrasound, RF, laser, etc.). Endoscopic surgical instruments can comprise a rod between the end actuator and a cable portion, which is handled 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. The positioning of an end actuator can also be facilitated by the inclusion of one or more articulated joints or features, allowing the end actuator to be selectively articulated or even offset in relation to the longitudinal axis of the stem.
    [0002] [0002] Examples of endoscopic surgical instruments include surgical staplers. Some of these staplers can be operated to staple layers of fabric, cut through stapled fabric layers, and urge staples through fabric layers to securely join separate layers of fabric near the separate ends of the fabric layers. Merely exemplary surgical staplers are presented in US Patent No. 4,805,823, entitled "Pocket Configuration for Internal Organ Staplers", issued on February 21, 1989; US Patent No. 5,415,334, entitled "Surgical Stapler and Staple Cartridge", issued May 16, 1995; US 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", issued 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; US 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; US 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 on December 4, 2007; US Patent No. 7,367,485, entitled "Surgical Stapling Instrument Incorporating a Multistroke Firing Mechanism Having a Rotary Transmission", published on May 6, 2008; US Patent No. 7,380,695, entitled "Surgical Stapling Instrument Having a Single Lockout Mechanism for Prevention of Firing", issued on June 3, 2008; US Patent No. 7,380,696, entitled "Articulating Surgical Stapling Instrument Incorporating a Two-Piece E-Beam Firing Mechanism", issued on June 3, 2008; US Patent No. 7,404,508, entitled "Surgical Stapling and Cutting Device", issued July 29, 2008; US Patent No. 7,434,715, entitled "Surgical Stapling Instrument having Multistroke Firing with Opening Lockout", issued 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 aforementioned US patents is incorporated into the present invention by reference. Although the aforementioned surgical staplers are described as 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.
    [0003] [0003] Although various types of surgical stapling instruments and associated components have been manufactured and used, it is believed that no one before the inventor (s) has manufactured or used the invention described in the embodiments. BRIEF DESCRIPTION OF THE DRAWINGS
    [0004] [0004] The attached drawings, which are incorporated into this specification and form part of it, illustrate modalities of the invention and, together with the general description provided above and the detailed description of the modalities provided below, serve to explain the principles of present invention.
    [0005] [0005] Figure 1A represents a perspective view of an articulated surgical instrument with an end actuator in a non-articulated position; Figure 1B represents a perspective view of the surgical instrument of Figure 1A with an end actuator in an articulated position; Figure 2 represents a perspective view of the open end actuator of the surgical instrument of Figures 1A and 1B; Figure 3A represents a side cross-sectional view of the end actuator of Figure 2, taken along line 3-3 of Figure 2, with the firing bar in a proximal position; Figure 3B represents a side cross-sectional view of the end actuator of Figure 2, taken along line 3-3 of Figure 2, but showing the firing bar in a distal position; Figure 4 represents a cross-sectional view of the end of the end actuator of Figure 2, taken along line 4-4 of Figure 2; Figure 5 represents an exploded perspective view of the end actuator of Figure 2; Figure 6 represents a perspective view of the end actuator of Figure 2, positioned on a fabric and having been activated once on the fabric; Figure 7 represents an exemplary end actuator with therapeutic agent and the associated dedicated device; Figure 8 represents a side cross-sectional view of the end actuator of Figure 7; Figure 9 represents an exploded perspective view of an alternative example cartridge assembly for an end actuator; and Figure 10 represents a perspective view of an end actuator with the cartridge set of Figure 9, the end actuator positioned and actuated on the fabric.
    [0006] [0006] The drawings are not intended to limit in any way, and it is envisaged 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 specification 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 provisions shown. DETAILED DESCRIPTION
    [0007] [0007] The following description of specific examples of the invention should not be used to limit the scope of the present invention. Other examples, characteristics, aspects, modalities and advantages of the invention will become evident to those skilled in the art from the following description, which uses illustrations, one of the best ways contemplated for carrying out the invention. As will be understood, the invention can have other different and obvious aspects, all without departing from the invention. Consequently, drawings and descriptions should be considered as illustrative rather than restrictive. I. Exemplary surgical stapler
    [0008] [0008] Figures 1 to 6 represent an exemplary surgical stapling and separation instrument 10 that is sized for insertion in a non-articulated state, as shown in Figure 1A, through the canal of the trocar cannula, to a surgical site in a patient undergoing a surgical procedure. The stapling and separation surgical instrument 10 includes a cable portion 20 connected to an implement portion 22, the latter further comprising a stem 23 that ends distally in a hinge mechanism 11 connected distally to the end actuator 12. When the hinge 11 and the distal end actuator 12 are inserted through the trocar cannula conduit, the hinge mechanism 11 can be hinged remotely, as shown in Figure 1B, by hinge control 13. Thus, the end actuator 12 it 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 cable 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 portion of cable 20. It will also be recognized that, for convenience and clarity, spatial terms such as "vertical" and "horizontal" are used in the present invention in connection with the drawings. However, surgical instruments can be used in many orientations and positions, and these terms are not intended to be limiting and absolute.
    [0009] [0009] The end actuator 12 of the present example includes a lower jaw 16 and an articulated anvil 18. The handle portion 20 includes a pistol grip 24, against which a closing trigger 26 is pivoted by the physician to in order to cause clamping or closing of 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 travels longitudinally in relation to the cable portion 20 in response to the articulated actuation of the closing trigger 26 against the pistol grip 24. A distal closing ring (33 of the closing sleeve 32 is indirectly supported by the structure (34 of the implement portion 22. In the articulation mechanism 11, a closing tube proximal 35 of the closing sleeve 32 communicates with the distal portion (closing ring) 33. The structure 34 is flexibly connected to the lower jaw 16 via the articulation 11, allowing articulation in a single plane. The structure 34 also supports, in a longitudinal and sliding way, a firing steering member (not shown), which extends through the rod 23 and transmits a firing movement from the firing trigger 28 to the firing bar 14. The firing trigger firing 28 is further from the closing trigger 26, being pressed jointly by the doctor to staple and separate the tissue clamped on the end actuator 12, as will be described in more detail below. Then, release button 30 is released to release tissue from end actuator 12.
    [0010] [00010] Figures 2 to 5 represent the end actuator 12 employing an E-beam firing bar 14 to perform various functions. As can best be seen in Figures 3A and 3B, the firing bar 14 includes a transverse-oriented upper pin 38, a firing-cap 44, a transverse-oriented middle pin 46 and a cutting edge in distal position 48. The upper pin 38 is located and translatable inside an anvil pocket 40 of the anvil 18. The firing bar cover 44 slidably engages the lower surface of the lower jaw 16, causing the firing bar 14 to extend along the groove in the groove 45 (shown in Figure 3B) that is formed along the lower jaw 16. The middle pin 46 slidably engages the top surface of the lower jaw 16, cooperating with the trigger bar cover 44. Thus, the firing bar 14 positively spaces the end actuator 12 during firing, avoiding mechanical tightening that can occur between the anvil 18 and the lower jaw 16 with a minimum amount of pinched tissue and e avoiding the malformation of staples when an excessive amount of tissue is clamped.
    [0011] [00011] Figure 2 shows the firing bar 14 positioned proximally and the anvil 18 hinged in the open position, allowing a cartridge of staples 37 not to be installed in the channel of the lower jaw 16 removably. As can best be seen in Figures 4 and 5, the staple cartridge 37 in this example includes the cartridge body 70, which contains an upper platform 72, and is coupled to a lower cartridge tray 74. As can best be seen in Figure 2, a vertical slot 49 is formed through part of the staple cartridge 37. Also, as can be seen better in Figure 2, three lines of staple openings 51 are formed through the upper platform 70 on one side of the vertical slot 49, with another set of three rows of clamp openings 51 formed through the upper platform 70 on the other side of the vertical slot 49. Returning to Figures 3 to 5, a wedge-shaped sliding support 41 and a plurality of clamp drivers 43 are captured between the cartridge body 70 and tray 74, with the wedge-shaped sliding support 41 located proximal to the clamp drivers 43. The wedge-shaped sliding support 41 is movable longitudinally inside staple cartridge 37; whereas the staple actuators 43 are movable vertically inside the staple cartridge 37. The staples 47 are also positioned inside the cartridge body 70, above the corresponding staple actuators 43. In particular, each staple 47 is propelled vertically inside the cartridge body 70 by a clamp actuator 43, in order to urge the clamp 47 through an associated clamp opening 51. As can best be seen in Figures 3A and 3B and 5, the wedge-shaped sliding support 41 has angled cam surfaces that push the clamp actuators 43 upward as the wedge-shaped sliding support 41 is propelled distally through the clamp cartridge 37.
    [0012] [00012] With the end actuator 12 closed, as shown in Figure 3A, the firing bar 14 is advanced engaged with the anvil 18, through the entrance of the upper pin 38 in a longitudinal slot of the anvil 42. A propeller block 80 is located at the distal end of the firing bar 14 and is configured to engage with the wedge-shaped sliding bracket 41 so that the wedge-shaped sliding bracket 41 is pushed distally by the drive block 80 as the firing 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 fabric between the staple cartridge 37 and the anvil 18. As shown in Figures 3A and 3B, the middle pin 46 and the propeller block 80, together, activate the staple cartridge 37 by entering a firing slot inside the staple cartridge 37, which takes the sliding form holder the wedge 41 to the upward contact of the cams with the clamp actuators 43, which, in turn, impels the clamps 47, through the clamp openings 51 and to the forming contact with the clamp-forming cavities 53 on the inner surface of the anvil 18. Figure 3B represents the firing bar 14 completely translated distally after the separation and stapling of the fabric are completed.
    [0013] [00013] Figure 6 shows end actuator 12 driven by a single stroke through fabric 90. As shown, the cutting edge 48 cut through fabric 90, while staple actuators 43 urged three alternating rows of staples 47 through fabric 90 on both sides of the cutting line produced by the cutting edge 48. The clamps 47 are all oriented substantially parallel to the cutting line in this example, although it should be understood that the clamps 47 can be positioned in any suitable orientations. In the present example, 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 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 number of cuts and staples 47 has been applied. Anvil 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.
    [0014] [00014] It should be understood that the cutting edge 48 can separate fabrics substantially at the same time that the clamps 47 are pushed through the fabric during each stroke of actuation. In the present example, the cutting edge 48 closely follows the insertion of the clips 47, so that a clip 47 is pushed through the fabric just before the cutting edge 48 passes through the same region of the fabric, although it should be understood that this order can reversed, or that the cutting edge 48 can be directly synchronized with the adjacent clips. Although Figure 6 shows the end actuator 12 being driven in two layers 92, 94 of fabric 90, it should be understood that end actuator 12 can be driven 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 staples 47 adjacent to the cut line produced by the cutting edge 48 can substantially join the tissue at the cut line, thereby reducing or preventing bleeding and / or leakage of other body fluids in the cut-line. Various suitable configurations and procedures in which the instrument 10 can be used will be apparent to those skilled in the art in view of the teachings contained herein.
    [0015] [00015] It should be understood that instrument 10 can be configured and is 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. 6,964,363; US patent No. 6,978,921; US patent No. 6,988,649; US patent No. 7,000,818; US patent No. 7,111,769; US patent No. 7,143,923; US patent No. 7,303,108; US patent 7,367,485; US patent 7,380,695; US patent No. 7,380,696; US patent No. 7,404,508; US patent No. 7,434,715; US patent No. 7,721,930; and / or US patent No. 7,455,208. 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 instrument 10 will be described in more detail below. Several 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 various teachings of the patents cited herein will be apparent to those skilled in the art. It should also be understood that the teachings below are not limited to the instrument 10 or the devices taught in the patents cited here. The teachings below can be readily applied to several other types of instruments, including instruments that would not be classified with 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. II. Exemplary modular end actuator
    [0016] [00016] Figures 7 and 8 show an exemplary modular end actuator 100 for applying a therapeutic agent to the tissue after using a stapling device, such as instrument 10. As shown in Figure 8, end actuator 100 includes the outer walls 102 that delimit the proximal portion 104 and the distal portion 106, the distal portion 106, including the mixing chamber 108 and the tip 110. Only by way of example, the tip 110 and the outer walls 102 can be constructed and operated in accordance with the teachings of the publication of US patent application No. 2008/0121657, entitled "Adhesive Dispenser for Surgery", published on May 29, 2008, the description of which is incorporated herein by reference.
    [0017] [00017] The end actuator 100 also includes separate reagent reservoirs or caps on separate sides of the inner wall 112, along the proximal portion 104 of the end actuator 100, to prevent premature mixing of the reagents. For example, the first agent 114 is disposed in the first guard chamber 116, on one side of the wall 112, and a second agent 118 is disposed in the second guard chamber 120 on the other side of the wall 112. As will be described below, the application of force with distal direction against the piston 122 will allow the reagents to mix in the distal portion 106 of the end actuator 100 and be applied to the tissue at the desired location by expelling through a hole formed at the tip 110.
    [0018] [00018] These reagents may include, but are not limited to, components of medicinal fluids, such as thrombin, low platelet plasma (PPP), platelet rich plasma (PRP), starch, chitosan, alginate, fibrin, polysaccharide, cellulose, collagen, gelatin-resorcinate-formalin adhesive, oxidized cellulose, mussel-based adhesive, poly (amino acid), agarose, amylose, hyaluronan, polyhydroxybutyrate (PHB), hyaluronic acid, poly (vinylpyrrolidone) (PVP), poly (alcohol vinyl) (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. Other components, materials, suitable substances, etc., that can be used in a medicinal fluid will be apparent to those skilled in the art, in view of the teachings of the present invention.
    [0019] [00019] In some versions, a medical fluid can be suspended in a biocompatible vehicle. Suitable vehicles may include, for example, a physiological buffer solution, a high flow gel solution, saline, and water. In the case of gel solutions, the tissue repair composition may be in a high flow gel form prior to release to the target site, or it may form a gel and remain in place after release to the target site. High-flow gel solutions may 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. Exemplifying gelling materials include the following: proteins such as collagen, collagen gel, elastin, thrombin, fibronectin, gelatin, fibrin, tropoelastine, polypeptides, laminin, proteoglycans, fibrin glue, fibrin clot, platelet-rich plasma clot (PRP) , platelet-poor plasma clot (PPP), self-assembled peptide hydrogels, Matrigel or atelocolagen; polysaccharides such as pectin, cellulose, oxidized regenerated cellulose, chitin, chitosan, agarose, or hyaluronic acid; polynucleotides such as ribonucleic acids or deoxyribonucleic acids; other materials include alginate, cross-linked alginate, poly (N-isopropylacrylamide), poly (oxyalkylene), copolymers of poly (ethylene oxide) -poly (propylene oxide), poly (vinyl alcohol), polyacrylate, or mono-stearoyl glycerol cossuccinate copolymers / polyethylene glycol (MGSA / PEG); and combinations of any of the previously mentioned. In addition to providing a high flow vehicle solution for tissue fragments, a gelling agent (s) can also act as an adhesive that anchors the tissue repair composition to a target site. In some versions, an additional adhesive anchoring agent may be included in the medical tissue or fluid repair composition. Also, one or more crosslinking agents can be used in conjunction with one or more gelling agents to crosslink the gelling agent.
    [0020] [00020] The modular end actuator 100 can be used as a replaceable and removable end actuator 100, with a device like instrument 10, or it can be used with a dedicated device, like device 124 shown in Figure 7. The end actuator 100 it can be sized for receiving by means of conventional trocars with various internal diameters. Returning to Figure 7, the end actuator 100 is positioned at the distal end of the stem 134, which is configured to receive the end actuator 100, removably, through the ring 126. The end actuator 100 is inserted in the ring 126 in the direction of the arrow (A) shown in Figure 7. The end actuator 100 is removably connected to the ring 126 at the distal end of the device 124, with extended ends or protrusions 136, for example, which can be received in the corresponding notches (not shown) of ring 126. Conversely, ring 126 may include protrusions received in the corresponding notches of end actuator 100 to connect ring 126 to end actuator 100. Certainly, ring 126 and end actuator 100 may include a variety of other components or features that can be operated to fix the end actuator 100 removably to the rod 134 of the device 124.
    [0021] [00021] The device 124 of the present example includes a trigger 128 for applying force against the piston 122, disposed at the proximal end of the end actuator 100, as shown in Figure 8, in order to move the piston 122 in the distal direction. In addition, a button 130 is disposed in the upper proximal portion of the device 124, in the handle 125. The button 130 is connected to a hinge segment 132 at the distal end of the stem 134, so that the hinge or actuation of the button 130 provides the corresponding articulation of the articulated segment 132, allowing the ring 126 and the connected end actuator 100 to be moved to the desired position above the clamps (47. The articulated segment 132 can articulate in the horizontal plane, along which the longitudinal axis of the rod 134 of the device 124 extends and / or in the vertical plane perpendicular to the horizontal plane.The horizontal or vertical articulation of the button 130 (for example, by means of the user's thumb) makes the corresponding horizontal or vertical articulation of the articulated segment 132. Alternatively, turning knob 130 clockwise or counterclockwise can make the corresponding articulation in the selected plane (in the horizontal or vertically, for example). The end actuator 100 and / or the stem 134 of the device 124 can also be rotated, with respect to the handle 125, about the longitudinal axis defined by the stem 124.
    [0022] [00022] Applying force to trigger 128 results in applying force in the direction of the arrow (B) in Figure 8 to apply it to piston 122 of end actuator 100. Various suitable components and configurations that can be used to convert the actuation of trigger 128 in actuation of piston 122 will be apparent to those skilled in the art in view of the teachings contained herein. Although the handle 125 is formed by a pistol grip with an articulated trigger, 128, it should be understood that the handle 125 and the trigger 128 can have any other suitable configuration.
    [0023] [00023] Piston 122 may comprise a single plunger with opening 138 to receive wall 112 of end actuator 100, or may include a formation with two plungers, each side moving along one side of wall 112. The piston 122 moves distally along the wall 112 to apply force against the proximal ends of the reservoirs or agents 114, 118 on one side of the wall 112, to move the agents 114, 118 distally towards the tip 110. The distal portion 106 of the end actuator 100 includes a tip 110, which has an opening through which a spray or other liquid form can be expelled, for example. Tip 110 also includes mixing chamber 108, bounded by end 140 of wall 112 and outer walls 102 of end actuator 100. Agents 114, 118, one of which may be fibrin and the other, thrombin, for example, are moved towards the rear end 140 of the wall 112, to mix in the mixing chamber 108 before being expelled by opening the tip 110 in the clips (47 of tissue (90, for example, as shown in Figure 10, as a therapeutic agent) or fabric repair composition 142.
    [0024] [00024] The use of end actuator 100 with an instrument, such as the instrument 10 described above, or with a dedicated device 124 can prevent the loss of reagents during application, which can occur in cases where the material reservoirs are located near the cable portion of the instrument or associated device. In these locations, the reagents can travel longer paths along the lumen inside the stem of the respective instrument or device, and portions of them can be deposited in the lumen, as a loss during the course. Along with reducing the amount lost, the use of end actuator 100 may allow the amount of reagent used inside reservoirs or capsules to be less than that which would be used if the reagent was positioned close to the handle portion of an instrument or device used to expel this reagent into the tissue. III. Foam block integrated into the end actuator cartridge
    [0025] [00025] In another version, shown in Figure 9, the 37A cartridge, as described above, can include an integrated foam block 144, containing an agent, such as a hemostatic agent, to assist in reducing the bleeding associated with separating and stapling the tissue via end actuator 12, as described above. Figure 9 shows an exploded view of the cartridge 37A for a removable installation in a channel of the lower jaw 16 of the instrument 10, which operates to separate and / or staple the fabric as described above. The bottom of the cartridge 146 includes a chamber 148, bounded by the peripheral walls of the bottom of the cartridge 146, into which the foam block 144 is inserted. The clamps (47 can be pre-installed on the foam block 144. Alternatively, the block 144 can be positioned between the clamps (47 and the underside of the cartridge platform, as cover 150. The clamps (47 can comprise a material selected from iron, nickel-titanium alloy, stainless steel and / or titanium, certainly any other suitable material (s) can be used in forming the clamps (47.
    [0026] [00026] The material for the foam block 144 may comprise, for example, auxiliary compound or hemostatic agents, such as fibrin or thrombin, or the materials described above which help to clot the blood and reduce the volume of bleeding at the surgical site. The hemostatic capabilities of these auxiliary compounds can also contribute to the use of these auxiliary compounds as adhesives and sealants. The agents can help to clot blood at the surgical site, which allows the tissue surrounding the blood to remain joined and can prevent leaks along the stapled tissue site, for example.
    [0027] [00027] Although a foam block is described in the example contained herein, the material may alternatively comprise a fibrous dressing, a matrix, a mesh or other structure, according to the teachings, by way of example, of the publication of the patent application US No. 2009/0120994, entitled "Surgical Fastening Device with Initiator Impregnation of a Matrix or Buttress to Improve Adhesive Application", published on May 14, 2009, the description of which is hereby incorporated by reference. The material can comprise, for example, a biocompatible material that is a surgical plate, a matrix with a plurality of openings, an open cell foam, a closed cell foam and / or a tissue dressing. The material can have a plurality of openings and can be a foam material containing those openings, or a mesh, or a filamentary structure, and can include porosities that induce capillary absorption to the addition of the adhesive to the material and ensure that the openings remain free of the adhesive, allowing tissue growth through the openings after application to the fabric.
    [0028] [00028] The cartridge 37A may have, with the integrated foam block 144, a height greater than that it would have without the said foam block, allowing staples with longer leg length to be used. The cap 150 includes openings 152, through which the clamps 47 can be pushed, and an elongated slot, through which the firing bar 14 can be fired, as described above. The cover 150 is arranged on the foam block 144 and can fit to the bottom of cartridge 146 of cartridge 37A, for example. Alternatively, the cap 150 can be molded to the bottom of the cartridge 146 of the cartridge 37A. Other suitable relationships between the lid 150 and the bottom of the cartridge 146 will be apparent to those skilled in the art in view of the teachings contained herein.
    [0029] [00029] As shown in Figure 10, when the end actuator 12 including the 37A cartridge is used, the reagent is applied to the fabric 90 during the activation of the clips (47 in the fabric 90, as the clips (47 are advanced through the block) foam 144 for receiving against anvil 18 and forming in closed staples 47, holding the tissue (90. The cartridge 37A and / or the anvil 18 may also include a separate layer of auxiliary compound or agent, which can be activated upon receiving the foamed coated clamps to allow the auxiliary compound to spread to tissue 90 together with receipt of clamps 47 to tissue 90. For example, thrombin or fibrin may be included and lyophilized with saline in foam block 144, they can be activated when mixed with each other when the clamps 47 inside the foam block 144 are pushed upwards towards the anvil 18, which can be coated with the other reagent.
    [0030] [00030] As the clamps (47 are pushed upward towards the anvil 18, the clamps 47 can be held in a substantially vertical orientation by initial placement in that direction when they are introduced into the foam block 144. Alternatively, if the clamps (47 are arranged below the foam block 144, in the chamber 148 at the bottom of the cartridge 146, the clamps 47 can be held in a substantially vertical orientation as the clamps 47 are pushed upwards towards the anvil 18, in a manner similar to that described above for the clamps 47 in the cartridge 37. The chamber 148 of the bottom of the cartridge 146 may include internal vertical walls, similar to those shown in Figure 4, defining vertical slots configured to receive the clamps 47 and to keep the clamps 47 in substantially vertical orientation before and during the thrust of the clamps 47 towards the anvil 18. In particular, each clamp 47 is propelled vertically inside the cartridge body 37A by a clamp driver 43, in order to urge the clamp 47 through an associated clamp opening 152. The wedge-shaped sliding support 41 has angled cam surfaces that push the clamp drivers 43 upwards as the sliding support in wedge shape 41 is propelled distally through the staple cartridge 37A.
    [0031] [00031] To adapt to the presence of foam block 144 in cartridge 37A, the wedge-shaped sliding support 41 and / or the clip drivers (43 can be modified to be larger or more resistant in the material used to manufacture the wedge-shaped sliding support 41 and / or the clamp actuators 43. Modifications can be made to provide sufficient additional force to drive the clamps 47 through the foam block 144, through the clamp openings 152 of the cover 150 and up to the conforming contact with the staple forming cavities (53 on the anvil 18. The increases in the size and / or strength properties of the material would be compared to the respective quantities used for the wedge-shaped sliding support 41 and / or staple drivers 43 push the staples 47 into the cartridge (37 through the staple openings 51 and up to the forming contact with the staple forming cavities 53 on the anvil 18, as described above.
    [0032] [00032] It must be understood that any one or more of the teachings, expressions, modalities, examples, etc. described here can be combined with any one or more of the other teachings, expressions, modalities, examples, etc. that are described here. The teachings, expressions, modalities, examples, etc. described below should not be seen in isolation from each other. Various suitable ways in which the teachings of the present invention can 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 in the scope of the embodiments.
    [0033] [00033] 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.
    [0034] [00034] Versions of the above can be designed to be discarded after a single use, or they can be designed for use multiple times. The versions can, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning can include any combination of steps to disassemble 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 the 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 before a surgical procedure. Those skilled in the art will understand that the reconditioning of a device can use 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 the present application.
    [0035] [00035] 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 and sealed container, such as a plastic or TYVEK bag. The container and the 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 on the device and the container. The sterile device can then be stored in a sterile container for later use. The device can also be sterilized using any other known technique, including, but not limited to, beta or gamma radiation, ethylene oxide or water vapor.
    [0036] [00036] In view of the presentation and description of several versions in this description, additional adaptations of the methods and systems described in this document can be made through appropriate modifications made by an element 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 the elements versed in the technique. For example, the examples, versions, geometry, materials, dimensions, proportions, steps and the like discussed above are illustrative only and are not mandatory. Consequently, the scope of the present invention must be considered in accordance with the terms of the embodiments and it is understood that it is not limited to the details of the structure and operation shown and described in the specification and drawings.
    权利要求:
    Claims (14)
    [0001]
    Surgical instrument comprising a cable portion, a rod that houses a firing bar, an end actuator comprising an anvil, a lower jaw and a clipping and separation mechanism responsive to a longitudinal closing movement produced by the cable portion and by the stem, the instrument further comprising a cartridge (37A), the lower jaw being configured to receive the cartridge (37A) when in an open position, comprising the cartridge (37A): (a) a cartridge bottom (146) including walls that delimit a chamber; (b) a plurality of clips (47) arranged in the chamber; (c) a foam block (144) arranged in the chamber; characterized by the fact that the cartridge (37A) still comprises: (d) a cover (150) disposed on the foam block and the chamber; the lid (150) comprising a plurality of openings (152) configured to receive the clips (47) upon activation of the separation and stapling mechanism in response to the longitudinal closing movement.
    [0002]
    Surgical instrument, according to claim 1, characterized by the fact that the lid (150) comprises a slot configured to receive the firing bar when activating the stapling and separation mechanism in response to the longitudinal closing movement.
    [0003]
    Surgical instrument according to claim 1, characterized by the fact that the plurality of clips (47) is inserted in the foam block.
    [0004]
    Surgical instrument according to claim 1, characterized by the fact that the plurality of clips (47) is arranged below the foam block.
    [0005]
    Surgical instrument according to claim 1, characterized by the fact that the lid (150) is fitted to the bottom of the cartridge (37A).
    [0006]
    Surgical instrument according to claim 1, characterized by the fact that the lid (150) is molded to the bottom of the cartridge (37A).
    [0007]
    Surgical instrument, according to claim 1, characterized by the fact that one of the plurality of clips (47) comprises a material selected from at least one of the following materials: iron, nickel alloy — titanium, stainless steel and titanium.
    [0008]
    Surgical instrument, according to claim 1, characterized by the fact that a plurality of clamps (47) are arranged in vertical slits delimited by the internal walls inside the chamber.
    [0009]
    Surgical instrument according to claim 1, characterized by the fact that a clamp driver is aligned with a respective clamp (47) of the plurality of clamps (47) and is configured to urge the clamp (47) through the foam block when activating the stapling and separation mechanism in response to the longitudinal closing movement.
    [0010]
    Surgical instrument according to claim 9, characterized by the fact that the instrument comprises a wedge-shaped sliding support configured to urge a staple actuator towards the anvil when activating the stapling and separation mechanism in response to longitudinal movement closing.
    [0011]
    Surgical instrument according to claim 1, characterized by the fact that the foam block comprises thrombin.
    [0012]
    Surgical instrument according to claim 1, characterized by the fact that the foam block comprises fibrin.
    [0013]
    Surgical instrument, according to claim 1, characterized by the fact that the foam block comprises one among thrombin or fibrin and the anvil is coated with the other among thrombin and fibrin.
    [0014]
    Surgical instrument, according to claim 1, characterized by the fact that one of the thrombin or fibrin is lyophilized with saline solution in the foam block.
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    同族专利:
    公开号 | 公开日
    CN103764045A|2014-04-30|
    PL2741687T3|2017-04-28|
    WO2013023114A1|2013-02-14|
    US9492170B2|2016-11-15|
    JP6104910B2|2017-03-29|
    EP2741687A1|2014-06-18|
    BR112014003068A2|2017-02-21|
    EP2741687B1|2016-09-21|
    CN103764045B|2016-10-05|
    JP2014529422A|2014-11-13|
    WO2013023114A8|2014-03-13|
    US20130037596A1|2013-02-14|
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    法律状态:
    2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-10-29| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-11-03| B09A| Decision: intention to grant|
    2021-01-12| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 10/08/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US13/206,752|2011-08-10|
    US13/206,752|US9492170B2|2011-08-10|2011-08-10|Device for applying adjunct in endoscopic procedure|
    PCT/US2012/050232|WO2013023114A1|2011-08-10|2012-08-10|Device for applying adjunct in endoscopic procedure|
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