专利摘要:
SURGICAL INSTRUMENT AND REINFORCEMENT MATERIAL. The present invention relates to an apparatus that includes a surgical instrument and that can be used to cut and staple a portion of tissue. In some versions, the device comprises a retaining cover. The retaining cap is in communication with the surgical instrument. The apparatus also comprises a reinforcement material operable to be coupled to a portion of the surgical instrument. In some versions, the reinforcement material may comprise a plurality of flaps or other similar structures for coupling the reinforcement material to the surgical instrument. In some versions, a cutter may be operable to uncouple the reinforcement material from the surgical instrument.
公开号:BR112014006247B1
申请号:R112014006247-1
申请日:2012-09-10
公开日:2021-02-02
发明作者:Venkataramanan Mandakolathur Vasudevan;John V. Hunt;Geoffrey C. Huiel;Israel Nur;Gregory J. Fanuele;Joseph B. Kraimer
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, 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 energy application 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.
[002] 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, in US Patent No. 5,415,334, entitled "Surgical Stapler and Staple Cartridge", granted on May 16, 1995, in US patent No. 5,465,895, entitled "Surgical Stapler Instrument", granted on November 14, 1995, in US patent No. 5,597,107, entitled "Surgical Stapler Instrument", granted in January 28, 1997, in US Patent No. 5,632,432, entitled "Surgical Instrument", granted on May 27, 1997, in US Patent No. 5,673,840, entitled "Surgical Instrument", granted on October 7, 1997 1997, in US Patent No. 5,704,534, entitled "Articulation Assembly for Surgical Instruments", granted on January 6, 1998, in US Patent No. 5,814,055, entitled "Surgical Clamping Mechanism", granted on September 29, 1998, in US Patent No. 6,978,921, entitled "Surgical Stapling Inst Incorporating an E-Beam Firing Mechanism ", issued December 27, 2005, in US patent No. 7,000,818, entitled" Surgical Stapling Instrument Having Separate Distinct Closing and Firing Systems ", granted on February 21, 2006, in the patent US No. 7,143,923, entitled "Surgical Stapling Instrument Having a Firing Lockout for an Unclosed Anvil", issued on December 5, 2006, in US Patent No. 7,303,108, entitled "Surgical Stapling Instrument Incorporating a Multi-Stroke Firing Mechanism with a Flexible Rack ", granted on December 4, 2007, in US patent No. 7,367,485, entitled" Surgical Stapling Instrument Incorporating a Multistroke Firing Mechanism Having a Rotary Transmission ", published on May 6, 2008, in the patent US No. 7,380,695, entitled "Surgical Stapling Instrument Having a Single Lockout Mechanism for Prevention of Firing", granted on June 3, 2008, in US Patent No. 7,380,696, entitled "Articulating Surgical Stapling Instrument I ncorporating the Two-Piece E-Beam Firing Mechanism ", granted on June 3, 2008, in US patent No. 7,404,508, entitled" Surgical Stapling and Cutting Device ", granted on July 29, 2008, in US patent no. ° 7,434,715, entitled "Surgical Stapling Instrument Having Multiple Shooting Courses with Opening Lock", granted on October 14, 2008, and in US Patent No. 7,721,930, entitled "Disposable Cartridge with Adhesive for Use with a Stapling Device ", granted May 25, 2010. The description of each of the aforementioned US patents is incorporated by reference into the present invention. 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.
[003] 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
[004] 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.
[005] Figure 1A represents a perspective view of a surgical instrument articulating 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 one articulated position, Figure 2 represents a perspective view of an open end actuator of the surgical instrument of Figures 1A to 1B, Figure 3A represents a side cross-sectional view of the end actuator of Figure 2, taken along the 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 distal position, Figure 4 represents a top cross-sectional view of the end actuator of Figure 2, taken along line 4-4 of Figure 2, Figure 5 represents a perspective view exploded view of the end actuator of Figure 2, Figure 6 represents a perspective view of the end actuator of Figure 2, positioned on the fabric and having been actuated once on said fabric, Figure 7 represents a perspective view of a cover retainer with the end actuator of Figure 2, Figure 8 represents a bottom perspective view of the retainer cover of Figure 7, Figure 9 represents a side view of the retainer cover with the end actuator of Figure 7, Figure 10 represents a top perspective view of an exemplary retainer cover with a reinforcement material, Figure 11A represents a side view of the retainer cover with the reinforcement material of Figure 10 being loaded onto an end actuator, Figure 11B represents a side view of the cover retainer with the reinforcement material of Figure 10, with the retainer cover being removed from the end actuator, leaving the reinforcement material loaded in the said end actuator, Figure 12A represents a cross-sectional view of an anvil of the end actuator with the reinforcement material of Figure 10, the reinforcement material being coupled to the anvil by means of a flap that engages with a anvil slit, Figure 12B represents a cross-sectional view of an anvil of the end actuator with the reinforcement material of Figure 10, the flap and fabric being cut by a cutter, Figure 12C represents a view in Serial cross section of an anvil of the end actuator with the reinforcement material of Figure 10, with the anvil being removed from the cut fabric, leaving the reinforcement material behind. Figure 13 represents a front cross-sectional view of an alternative exemplary version of an anvil, and an alternative exemplary version of T-shaped flaps. Figure 14 represents a front cross-sectional view of another alternative version. example of an anvil that has notches, and of another alternative version of example of flaps, and Figure 15 represents a perspective view of the reinforcement material of Figure 10, having been applied to the tissue during the use of a surgical instrument.
[006] The drawings are not intended to limit in any way, and it is envisaged that various modalities of the invention may be carried out in a variety of other ways, including those not necessarily represented in the drawings. The attached 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
[007] 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. Exemplary surgical stapler
[008] Figures 1 to 6 represent an exemplary surgical cutting and stapling instrument 10 that is sized for insertion, in a non-articulated state as shown in Figure 1A, through the passage of a trocar cannula and up to a surgical site in a patient, to perform a surgical procedure. The surgical cutting and stapling instrument 10 includes a cable portion 20 connected to an implement portion 22, the latter additionally comprising a rod 23 distally terminating in a hinge mechanism 11 and an end actuator 12 connected distally. Once the hinge mechanism 11 and the end actuator 12 are inserted through the passage of the trocar cannula, the hinge mechanism 11 can be remotely articulated, as shown in Figure 1B, through the hinge control 13. Thus , the end actuator 12 can reach behind an organ or approach a 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.
[009] 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 pivotally pressed 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 supported indirectly by the structure 34 of the implement portion 22. In the articulation mechanism 11, a proximal closing tube 35 the closure sleeve 32 communicates with the distal closing ring 33. The structure 34 is flexibly connected to the lower jaw 16 via the articulation mechanism 11, allowing articulation in a single plane. The structure 34 also supports, in a longitudinal and sliding way, a firing guiding 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 away 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, the release button 30 is released to release the tissue from the end actuator 12.
[0010] Figures 2 to 5 represent the end actuator 12 employing an electron beam firing bar 14 to perform a number of 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 jaw16, cooperating with the trigger bar cover 44. Likewise, 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 ev preventing the malformation of staples when an excessive amount of tissue is clamped.
[0011] Figure 2 shows the firing bar 14 located proximally and the anvil 18 pivoted to an open position, allowing an unexhausted staple cartridge 37 to be installed removably within a lower jaw channel 16. As best 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. As can also be seen in Figure 2, three rows of staple openings 51 are formed through the upper platform 72 on one side of the vertical slot 49, with a another set of three rows of openings for clamp 51 being formed through the upper platform 72 on the other side of the vertical slot 49. Returning to Figures 3 to 5, a sliding wedge-shaped support 41 and a plurality of clamp actuators 43 are captured between the body of the cartridge 70 and the tray 74, with the wedge-shaped sliding support 41 proximal to the clamp drivers 43. The wedge-shaped sliding support 41 is movable longitudinally in the inside the staple cartridge 37, while 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 clamp 47 is propelled vertically inside the cartridge body 70 by a clamp actuator 43, in order to impel 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 staple cartridge 37.
[0012] 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 the wedge-shaped sliding bracket 41 so that the wedge-shaped sliding bracket 41 is pushed distally by the propeller 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 pinched 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 actuate the staple cartridge 37 together by entering the slot 49, inside the staple cartridge 37, inserting the wedge sliding part 41 of mod which enters an eccentric contact upwards with the clamp actuators 43 which, in turn, guide the clamps 47 out through the clamp openings 51 and so that they enter into a forming contact with the clamp forming recesses 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] Figure 6 shows the end actuator 12 having been actuated by means of a single touch through the fabric 90. The cutting edge 48 cut through the fabric 90, while the staple actuators 43 drove three alternating rows of staples 47 through of the fabric 90, on each side of the cutting line produced by the cutting edge 48. The staples 47 are all oriented substantially parallel to the cutting line in this example, although it should be understood that the staples 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 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 anvil 18 may need to be opened to facilitate replacement of the staple cartridge 37.
[0014] 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 be 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 fabric 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] It should be understood that instrument 10 can be configured and function in accordance with any other teachings of US patents No. 4,805,823, US No. 5,415,334, US No. 5,465,895, US No. 5,597. 107, US No. 5,632,432, US No. 5,673,840, US No. 5,704,534, US No. 5,814,055, US No. 6,978,921, US No. 7,000,818, US No. 7,143,923 , US No. 7,303,108, US No. 7,367,485, US No. 7,380,695, US No. 7,380,696, US No. 7,404,508, US No. 7,434,715 and / or US No. 7,721. 930.
[0016] 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. Exemplary cover
[0017] Figures 7 to 9 show an exemplary staple cartridge retainer 180, which can be attached to staple cartridge 37. It should be understood that retainer cover 180 can be configured and functional according to any the teachings of the patent application with serial number US 12 / 894,369, entitled "Implantable Fastener Cartridge Comprising a Support Retainer" and filed on September 30, 2010, and / or of the patent application with serial number US 13 / 097,924, entitled "Staple Cartridge Comprising a Tissue Thickness Compensator" and filed on April 29, 2011, the descriptions of which are incorporated herein, by reference, in their entirety. The retaining cap 180 works to prevent, or at least prevent, a doctor's thumb, for example, from contacting the tips of the staples 47 positioned inside the staple cartridge 37, when the staple cartridge 37 is inserted into the lower jaw 16 of the end actuator 12. In addition, or as an alternative, it can prevent the clamps 47 from inadvertently falling out of the cartridge. Now with reference to Figures 7 and 8, the retaining cap 180 of the present example includes a lower surface 181 and an upper surface 182, which can provide a pushing surface so that, for example, the physician applies downward force to them. In a purely exemplary use, the physician may hold the cable portion 184 of the retaining cap 180, align the support portion 110 of the clamp cartridge 37 with the lower jaw 16 of the end actuator 12, and insert at least partially the clamps 37 in the lower jaw 16 of the end actuator 12. Then, the doctor can fully engage the staple cartridge 37 in the lower jaw 16 of the end actuator 12, by applying downward force to the upper surface 182 of the retaining cover 180, which can transmit the downward force directly to the support portion 110. In the present example, the retaining cap 180 comprises proximal supports 187 that extend downwards and come into contact with the surface of the platform 111 of the support portion. The retaining cap 180 additionally comprises a distal support portion 183, which is contiguous with the nose 103. When a downward force is applied to the retaining cap 180, said downward force can be transmitted through proximal supports 187 and / or of the distal support portion 183. In some exemplary versions, at least some of the supports may not be in contact with the top of the support portion 110 before the downward force is applied to the retaining cap 180 but, in some versions, the retaining cap 180 can function to flex or move downward, until the retainer cover 180 touches the top of the support portion 110. At that point, the flexion or downward movement of the retainer cover 180 can be prevented, or at least less substantially impeded, from any further progression.
[0018] As described above, the retainer cover 180 can be attached to the staple cartridge 37 and can be used to manipulate the position of the staple cartridge 37. In some versions, the retainer cover 180 can comprise any suitable number of gripping elements which can function to releasably secure the retaining cap 180 of the support portion 110 of the staple cartridge 37, for example. For example, in the present example, the retaining cap 180 comprises locking arms 188 and 189. Locking arms 189 extend around the sides of the nose 103 and engage with the lower surface 109 Figure 7 of the nose 103. Similarly, the locking arms 188 extend around the sides of the locking projections 108 extending from the support portion 110, and engage with the lower surfaces of the locking projections 108. These locking arms 188 work in order to position the retainer cover 180 over the zone or region in which the clamps 47 are stored within the support portion 110. In any case, once the clamp cartridge 37 has been properly positioned, the retainer cover 180 can be separated from the clamp cartridge. staples 37. Of course, any other suitable components or features can be used to provide releasable coupling from retaining cap 180 to the staple cartridge 37. In some versions, the physician it can apply an upward lifting force to the cable 184 so as to separate the distal end of the retaining cap 180 and the distal end 102 of the staple cartridge 37. In at least one such embodiment, the locking arms 188 and 189 can flex outward, as the cable 184 is lifted upwards, so that the locking arms 188 and 189 can flex around the lock projections 108 and the nose 103, respectively. Then, the proximal end of the retaining cap 180 can be lifted away from the proximal end 101 of the staple cartridge 37, and the retaining cap 180 can be moved away from the staple cartridge 37. With the cap retainer 180 removed, and with the staple cartridge 37 properly seated in the lower jaw 16 of end actuator 12, instrument 10 can then be used in a surgical procedure. Exemplary reinforcement material
[0019] In some exemplary versions, the retaining cap 180 can be used in conjunction with a reinforcement material 200 as shown, for example, in Figures 10 to 12C. It may be desirable to use reinforcement material 200 when cutting and / or stapling tissues, to assist in supporting and healing the cut area. In the present example, reinforcement material 200 comprises a coagulant that works to reinforce a surgical site when it is cut and stapled. For example, reinforcement material 200 may comprise fibrin and thrombin, but any suitable coagulant can be used, as would be apparent to the person skilled in the art in view of the teachings contained herein. Furthermore, reinforcement material 200 may comprise a hemostatic agent, any suitable adhesive material, for example acellular tissue, allogeneic or xenogenic, collagen, gelatin, oxidized regenerated cellulose ORC, degradable synthetic and non-woven synthetic materials, such as polylactate, polyglycol, polyguproic acid or any other suitable material, as would be evident to the person skilled in the art in view of the teachings contained herein. In some exemplary versions, reinforcement material 200 may comprise a fibrin pad. In addition, reinforcement material 200 may comprise any combination of a variety of suitable materials.
[0020] As shown in the exemplary version, the reinforcement material 200 can be placed on the upper surface of the retaining cover 180, as well as on the lower surface of the retaining cover 180, to extend over substantially the entire length of the retaining cover. 180. In some exemplary versions, the reinforcement material 200 placed on the upper surface of the retainer cover 180 has a different material composition than that of the reinforcement material 200 placed on the lower surface of the retainer cover 180. For example, a portion of the material reinforcement 200 may comprise fibrin, while the other portion of reinforcement material 200 may comprise thrombin. However, various materials suitable for reinforcement material 200 may be used, as would be evident to the person skilled in the art in view of the teachings contained herein. In the illustrated version, the reinforcement material 200 is generally evenly spread over the entire upper surface and the lower surface of the retaining cover 180, but it should be understood that the reinforcement material 200 can be distributed in different portions on the upper surface and on the lower surface of the retainer cover 180. For example, a greater amount of reinforcement material 200 can be placed on the upper surface of the retainer cover 180, or a greater amount of reinforcement material 200 can be placed on the lower surface of the retainer cover 180. Furthermore, the reinforcement material 200 can be placed only on the upper surface of the retaining cover 180, or the lower surface of the retaining cover 180. Any suitable distribution of reinforcement material 200 can be used along the retaining cover 180. , as would be evident to the person skilled in the art in view of the teachings contained The reinforcement material 200 comprises a semi-rigid and / or rigid structure, so that when separated from the retaining cover 180, as will be described below, the reinforcement material 200 is able to maintain, in general, its flat configuration and rectangular.
[0021] As shown in Figure 10, a plurality of resilient flaps 210 are positioned along the upper surface of the reinforcement material 200. The flaps 210 are spaced and aligned in a generally longitudinal manner along the center of the reinforcement material 200. The flaps 210 are additionally arranged to face alternating lateral directions along the length of the reinforcement material 200. It should be understood that the lower portion of the reinforcement material 200 may also comprise flaps 210 extending similarly in a opposite direction from the flaps 210 positioned on the reinforcement material 200.
[0022] Each of the flaps 210 comprises a head portion 212 and a body portion 214. The flaps 210 are generally aligned so that they fit under pressure within the longitudinal slot of the anvil 42, shown in Figures 12A to 12C, from so that the reinforcement 200 is mechanically coupled to the anvil 18 when the retaining cap 180 is pressed against the anvil 18. The head portion 212 of the flaps 210 is shaped like a wedge, so that the head portion 212 can be easily forced into the longitudinal slit of the anvil 42, without it being able to be removed from it once it is in place. The flaps 210 are coupled to the reinforcement material 200 so that the reinforcement material 200 can be coupled to the anvil 18 by means of flaps 210 coupling to the longitudinal slot of the anvil 42. Although the illustrated version represents flaps 210 as having a shape wedge-like, any suitable shape can be used, including a T-shape or a bulb-like shape. Various other formats suitable for the flaps 210 and / or for the head portion 212 will be evident to those skilled in the art, in view of the teachings contained herein.
[0023] Figure 11A shows the reinforcement material 200 and the retaining cap 180 being loaded in the lower jaw 16. The anvil 18 is not yet coupled to the reinforcement material 200, and remains open. In this way, a user may be able to observe whether the reinforcement material 200 and the retaining cap 180 are properly aligned within the lower jaw 16, before closing the anvil 18 to engage the reinforcement material 200.
[0024] As can be seen in Figure 11B, the anvil 18 and the lower jaw 16 closed on the retainer cover 180, which is covered with the reinforcement material 200, thus making the flaps 210 fit by pressure inside of the longitudinal slot of the anvil 42. A portion of the reinforcement 200 can also be coupled to the lower jaw 16 by fixing it to a staple cartridge (not shown) positioned inside the lower jaw 16. Furthermore, the lower jaw 16 comprises a longitudinal slit in the lower jaw 43, similar in shape to the longitudinal slit in the anvil 42, to engage the flaps 210 of the reinforcement 200. Then, the anvil 18 and the lower jaw 16 can be opened, leaving an upper portion of the material reinforcement 216 coupled to the anvil 18 and a lower portion of the reinforcement material 218 coupled to the lower jaw 16. It should be understood that the retaining cap 180 can be maintained between the anvil 18 and the lower jaw 16 to until instrument 10 is ready for use. It should also be understood that other suitable configurations can be used. For example, the reinforcement material 200 can be coupled only to the anvil 18. In other merely exemplary versions, the reinforcement material 200 can be coupled only to the lower jaw 16. In still other exemplary versions, the reinforcement material 200 can be directly coupled to the lower jaw 16 and / or the anvil 18, without the use of the retainer cover 180. In some versions, the reinforcement material 200 and the retainer cover 180 can be preloaded on the anvil 18 and the lower jaw 16, so that the user only needs to remove the retaining cap 180 before use.
[0025] Figures 12A to 12C show a series of cross-sectional views of anvil 18 coupled to the reinforcement material 200 with flaps 210 fitted inside the longitudinal slot of the anvil 42, and with the fabric 90 pressed against the reinforcement 200. A Figure 12A shows the reinforcement 200 loaded on the anvil 18, with the flaps 210 pressed into the groove of the anvil 42. The head portion 212 works to prevent the reinforcement 200 from inadvertently loosening from the anvil 18.
[0026] Figure 12B shows the cutting edge 48, which is shown in Figures 1 to 6, as it travels along the length of the longitudinal slit of the anvil 42. The cutting edge 48 cuts through the head portion 212 of the flaps 210, thus decoupling the flaps 210 from the longitudinal slot of the anvil 42. As can be seen in Figure 12B, the body portion 214 of each of the flaps 210 is slightly off-center, so that only the head portion 212 is cut as the cutting edge 48 advances through the longitudinal slit of the anvil 42. As it advances, the cutting edge 48 cuts the fabric 90, so that the fabric 90 and the flaps 210 are cut substantially simultaneously. In addition, as the cutting edge 48 advances, an upper pin, which is shown for example in Figure 3A, moves with the cutting edge 48 and forces the head portion 212 out of the anvil slot 42. The flaps 210 comprise a material biodegradable, so that the portions of the flaps 210 released inside the fabric 90 finally dissolve or otherwise remain biologically inert, without exposing the fabric 90 to any danger.
[0027] As can be seen in Figure 12C, as the cutting edge 48 cuts through the fabric 90, the reinforcement material 200 is stapled to the fabric 90 with staples 47 and, in addition, supports and / or heals the surrounding fabric 90 , and / or reinforces the staple line 47. In the exemplary version, the body portion 214 of the flaps 210 can remain attached to the reinforcement material 200, and / or can simply dissolve as the cut tissue heals. Furthermore, as the material of the tissue 90 heals, the reinforcement material 200 may dissolve. In some alternative versions, the reinforcement material 200 can be removed once the tissue 90 is sufficiently healed.
[0028] Figure 13 shows another merely illustrative version of the flaps 310, having a split T shape and continuously extending along the length of the reinforcement material 300. Instead of fitting inside the longitudinal slot of the anvil 342 with complementary shape, the flaps 310 in communication with the reinforcement material 300 can be slid longitudinally into the longitudinal slot of the anvil 342 with complementary shape. In other exemplary versions, tabs 310 may have a split mushroom shape. It should be understood that the divided mushroom shape can work in order to offer easier insertion of the flaps 310 into the anvil slot 342, as it has a slightly rounded portion. Whether in the split-T-shaped or split-mushroom configuration, it should be understood that, as you proceed to cut fabrics 90, as described for example in Figures 1 to 6, the cutting edge 48 can deflect and / or deform the flaps 310, so that they can be easily removed from the anvil slit 342 as a result of the deformation of the flaps 310. In still other exemplary versions, as you proceed to cut the fabric 90, the cutting edge 48 can tear off a portion and / or the entire flaps 310, enough to cause them to disengage from the groove of the anvil 342.
[0029] In yet another exemplary version, shown in Figure 14, the reinforcement material 400 can be in communication with the clips 410 that work in order to engage a series of corresponding external notches 442 on the anvil 418, to couple the reinforcement material 400 to anvil 418. Once the fabric 90 has been cut and stapled, the user can disengage the clips 410 to decouple the reinforcement material 400 from the anvil 418. Other exemplary configurations for coupling the reinforcement material 400 to the anvil 418 will be evident to those skilled in the art, in view of the teachings contained herein.
[0030] Figure 15 shows the instrument for surgical cutting and stapling 10, after being used to cut and staple 90 fabrics. As can be seen in the present example, reinforcement 200 was stapled to fabric 90 and then can help in recovery even by stabilizing staples 47 on fabric 90.
[0031] 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.
[0032] 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.
[0033] The versions described above can be designed to be discarded after a single use, or they can be designed to be used 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.
[0034] 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 exterminate 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.
[0035] In view of the presentation and description of various versions in the present disclosure, 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 in the drawings.
权利要求:
Claims (8)
[0001]
1. An apparatus comprising: (a) a surgical instrument (10) comprising an anvil (18), in which the anvil (18) comprises a longitudinal slit in the anvil (42), in which the surgical instrument (10) is configured to cut and staple a portion of tissue, and comprises a cutter (14) that advances distally, with the surgical instrument (10) defining a longitudinal center, with the cutter (14) advancing along the longitudinal center of the surgical instrument (10), and the surgical instrument (10) comprises a proximal end and a distal end; (b) a retaining cap (180) connected to the distal end of the surgical instrument (10), the retaining cap (180) being operable to cover at least a portion of the distal end of the surgical instrument (10); and (c) a reinforcement material (200) disposed in the retaining cap (180), the reinforcement material (200) being configured to be coupled to a portion of the distal end of the surgical instrument (10), with the retaining cap (180) is configured to be removed from the distal end of the surgical instrument (10) without uncoupling the reinforcement material (200) from the distal end portion of the surgical instrument (10), with the reinforcement material (200) being additionally configured to disengage from the distal end portion of the surgical instrument (10), characterized by the fact that the reinforcement material (200) is configured to couple with the longitudinal slit of the anvil (18), and the reinforcement material (200) further comprises a plurality of flaps (210) configured to press fit into the longitudinal slit of the anvil (18), the plurality of flaps (210) being arranged so as to be slightly displaced from the longitudinal center of the instrument the surgical (10), and each of the plurality of flaps (210) comprises a body portion (214) and a head portion (212), with the cutter (14) being configured to cut the portion of head (212) as the cutter (14) advances distally.
[0002]
2. Apparatus according to claim 1, characterized by the fact that the plurality of flaps (210) comprise soluble flaps (210).
[0003]
Apparatus according to claim 1, characterized by the fact that the plurality of flaps (210) are arranged so that the flaps (210) face alternating lateral directions along the length of the reinforcement material (200) .
[0004]
4. Apparatus according to claim 1, characterized by the fact that the reinforcement material (200) comprises a hemostatic agent.
[0005]
Apparatus according to claim 1, characterized by the fact that the reinforcement material (200) comprises a fibrin pad.
[0006]
6. Apparatus according to claim 1, characterized by the fact that the distal end of the surgical instrument (10) comprises the anvil (18) and a lower jaw (16), the anvil (18) and the lower jaw (16) are configured to clamp the reinforcement material (200) around a fabric to be cut and stapled, so that the reinforcement material (200) presses the fabric to be cut and stapled.
[0007]
Apparatus according to claim 1, characterized in that at least a portion of the reinforcement material (200) comprises a soluble material.
[0008]
8. Apparatus according to claim 1, characterized by the fact that the retaining cover (180) comprises an upper surface and a lower surface, with the reinforcement material (200) covering the upper surface of the retaining cover (180) , the reinforcement material (200) additionally covering the lower surface of the retaining cover (180).
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同族专利:
公开号 | 公开日
EP2755571A1|2014-07-23|
CN103930047A|2014-07-16|
MX2014003174A|2014-09-22|
US20130068816A1|2013-03-21|
JP2014533122A|2014-12-11|
WO2013039825A1|2013-03-21|
EP3689263A1|2020-08-05|
RU2619379C2|2017-05-15|
EP2755571B1|2020-01-01|
JP6133299B2|2017-05-24|
CN103930047B|2016-12-28|
BR112014006247A2|2017-04-11|
RU2014114834A|2015-10-20|
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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]|
2019-10-29| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
2020-11-24| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
2021-02-02| 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 10/09/2012, OBSERVADAS AS CONDICOES LEGAIS. |
优先权:
申请号 | 申请日 | 专利标题
US13/233,664|US20130068816A1|2011-09-15|2011-09-15|Surgical instrument and buttress material|
US13/233,664|2011-09-15|
PCT/US2012/054412|WO2013039825A1|2011-09-15|2012-09-10|Surgical instrument and buttress material|
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