• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    SURGICAL CLAMP CARTRIDGES AND EXTREMITY ACTUATORS WITH VESSEL MEASUREMENT PROVISIONS. The present invention relates to surgical staple cartridges and end actuators for assessing a size of tissue stapled by the staple cartridge or otherwise manipulated by the end actuator. In various forms, the staple cartridge has, at the base of the holder, at least a series of measurement signals that can be seen from a position above the surface of the holder, when the anvil is pinching the fabric over the staple cartridge. Other embodiments include a structure for forming a marking on the cartridge holder that corresponds to a size of the fabric supported on it. Methods for cutting and stapling fabrics are also presented.
    公开号:BR112013023486B1
    申请号:R112013023486-5
    申请日:2012-03-13
    公开日:2020-11-24
    发明作者:Megan A. O'connor；Robert P. Kruth；Jeffrey S. Swayze
    申请人:Ethicon Endo-Surgery, Inc；
    IPC主号:
    专利说明:

    BACKGROUND Technical Field
    [0001] The present invention relates to a surgical instrument and, in various modalities, to surgical end actuators used to manipulate and / or treat tissues, as well as instruments for surgical stapling, end actuators and staple cartridges for them, that are designed to cut and staple fabrics. Background
    [0002] Instruments for surgical cutting and stapling have been used to make a longitudinal incision in the tissue and simultaneously apply staple lines on opposite sides of the incision. Such instruments commonly include a pair of cooperating claw elements which, if the instrument is intended for endoscopic or laparoscopic applications, are capable of passing through a cannula passage. One of the jaw elements commonly supports a staple cartridge that operationally supports at least two laterally spaced rows of unformed staples. The other jaw element defines an anvil that has staple-forming pockets that, when the anvil is closed, are aligned with rows of unformed staples supported on the cartridge.
    [0003] During use, a doctor is able to close the jaw elements of the cutting and stapling instrument on the tissue, to position the tissue before activating the instrument. Once the doctor has determined that the jaw elements are clamping the target tissue correctly, the doctor can then trigger or "fire" the instrument, thus cutting and stapling the tissue. Simultaneous positioning and stapling prevent complications that may arise during the sequential execution of these actions with different surgical instruments that only section or staple the tissue, respectively.
    [0004] Various instruments for surgical cutting and stapling are known that can be used laparoscopically and / or in conjunction with various "open" surgical procedures. Some surgical cutting and stapling instruments are configured to drive replaceable cartridges that hold unformed staples inside. These devices commonly employ a retractable cutting element, which remains with the instrument for stapling and can be reused with several cartridges. Once the clips are fired on a cartridge, the cutting element is retracted and the spent cartridge is removed to allow a new cartridge to be installed, if desired. As the cutting element is guided distally through the cartridge, the unformed clips are fired out of their respective pockets on the cartridge, entering a forming contact with the underside of the anvil. Examples of such devices are presented in US Patent No. 7,000,818, entitled "Surgical Stapling Instrument Having Separate Distinct Closing and Firing Systems", issued on February 21, 2006, the description of which is incorporated herein in its entirety, for reference.
    [0005] Other instruments for surgical cutting and stapling employ what is commonly called "disposable loading unit" or "UDC". These devices support a staple cartridge and a scalpel without prior use in the form of a "unit" that is configured to be operationally attached to the cutting and stapling instrument. The units are designed to be discarded after the clips are fired. Examples of these instruments are presented in US Patent No. 5,865,361, entitled "Surgical Stapling Apparatus", issued on February 2, 1999, the description of which is incorporated herein by way of reference, in its entirety.
    [0006] In many surgical procedures and, in particular, in many surgical procedures related to the vascular system, it may be advantageous for the surgeon to know the size (that is, the diameter) of the blood vessel being transected and stapled, for hemostatic purposes. Some of the existing surgical devices for cutting and stapling offer measurement lines on the sides of a channel that supports the surgical staple cartridge. However, these measurement lines are typically visible only from the sides of the end actuator and thus can be obscured by the blood vessel being cut and stapled. If the surgeon looks at the end actuator from a position above, these measurement lines are not visible and may be of little use in determining the size of the blood vessel being stapled. Consequently, there is a need for surgical staple cartridge and end actuator arrangements that provide feedback regarding the size of the tissue being transected and stapled.
    [0007] A variety of other end actuator arrangements are also used by surgeons to manipulate tissues. Such devices, for example surgical clamping devices, include movable jaws to clamp tissues between them. It would also be advantageous if these and other devices used to treat / manipulate vascular tissue and the like provided the user with feedback regarding the size of the tissue being treated / manipulated.
    [0008] The aforementioned discussion is only intended to illustrate some of the disadvantages present in the field of the invention at the moment, and should not be taken as a denial of the scope of the embodiments. SUMMARY
    [0009] According to the general aspects of at least one form, a surgical staple cartridge is presented that includes a cartridge body, which operationally supports a plurality of surgical staples inside. The cartridge body has a proximal end and a distal end, and a support extending between them. The tissue measurement means are arranged on the support to determine the size of a tissue placed on it.
    [0010] According to other general aspects of at least one form, a surgical end actuator is presented for use with a surgical instrument. In various forms, the end actuator includes an elongated channel that is operably attachable to the surgical instrument. A staple cartridge having a cartridge body is operatively supported on the elongated groove. The cartridge body has a support surface that is substantially divided into a first portion of the support and a second portion of the support by means of a longitudinal slot extending between them. The cartridge body operationally supports, inside, a first plurality of unformed clips that correspond to the first portion of the support. The cartridge body additionally operationally supports a second plurality of unformed clips corresponding to the second portion of the support. A tissue cutter element is operationally supported on the cartridge body for axial advancement in the longitudinal slot by applying a cutting drive movement by the surgical instrument. An anvil is supported in order to follow a path that approaches and moves away from the surface of the support, in response to the opening and closing movements applied to it by the surgical instrument. The measuring medium is arranged on at least one of the support surface and the anvil, to determine a size of the tissue placed on it.
    [0011] According to yet other general aspects of at least one shape, a method for cutting and stapling fabrics is presented. In various forms, the method comprises clamping a piece of tissue between a surgical staple cartridge and an anvil, and forming a marking on a portion of the surgical staple cartridge holder that corresponds to a size of the clamped tissue. The method further comprises cutting the pinched fabric to form two cut end portions, and stapling each cut end portion. BRIEF DESCRIPTION OF THE DRAWINGS
    [0012] The characteristics mentioned above and other characteristics and advantages of this invention, and the way of obtaining them, will become more apparent and the invention itself will be better understood by reference to the following description of modalities of the invention, taken in conjunction with the attached drawings, in which: FIG. 1 is a perspective view of a form of an instrument for surgical cutting and stapling with which various forms of cartridges and end actuators of a form of the present invention can be used; FIG. 2 is an exploded view of an end actuator embodiment of the present invention; FIG. 3 is a perspective view of a staple cartridge embodiment of a form of the present invention; FIG. 4 is a partial perspective view of the end actuator portion of the instrument of FIG. 1 in an open position and before clamping a piece of fabric inside; FIG. 5 is a plan view of a portion of an end actuator modality pinching a blood vessel between the anvil and the staple cartridge thereof; FIG. 6 is a plan view of a portion of another type of end actuator pinching a blood vessel between the anvil and the staple cartridge thereof; FIG. 7 is a perspective view of another embodiment of a surgical staple cartridge in a form of the present invention; FIG. 8 is a plan view of a portion of another embodiment of the end actuator pinching a blood vessel inside; and FIG. 9 is a partial perspective view of the end actuator of FIG. 8, after the anvil has been moved to an open position and the pieces of fabric have been removed from it. DETAILED DESCRIPTION
    [0013] Certain exemplary modalities will now be described to provide a general understanding of the principles of structure, function, manufacture and use of the instruments and methods described here. One or more examples of these modalities are illustrated in the attached drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are exemplary non-limiting modalities, and that the scope of the various modalities of the present invention is defined only by the embodiments. The reference from the beginning to the end of the description of "various modalities", "some modalities", "a modality", or "the modality", or similar, means that an attribute, structure, or characteristics described in conjunction with the modality is included in at least one modality. Therefore, the appearance of the phrases "in various modalities", "in some modalities", "in one modality", or "in modality", or similar, in places from beginning to end of the specification are not necessarily all referring to the same modality. In addition, the particular attributes, structures, or characteristics can be combined in any suitable way in one or more modalities. Therefore, the particular attributes, structures, or features illustrated or described in conjunction with a modality can be combined, in whole or in part, with the structures of the attributes, or features of one or more other modalities without limitation. These modifications and variations are intended to be included in the scope of the various modalities presented in the present invention, and their respective equivalents.
    [0014] The terms "proximal" and "distal" are used in the present invention with reference to the manipulation that a physician makes of the handle portion of the surgical instrument. The term "proximal" refers to the portion closest to the physician, and the term "distal" refers to the portion situated furthest from the physician. It will also be understood that, for the sake of convenience and clarity, spatial terms such as "vertical", "horizontal", "up" and "down" can be used in the present invention with respect to the drawings. However, surgical instruments can be used in many orientations and positions, and these terms are not intended to be limiting and / or absolute.
    [0015] Various instruments and exemplifying methods for performing minimally invasive laparoscopic surgical procedures are presented. However, the person skilled in the art will readily understand that the various methods and instruments presented herein can be used in numerous surgical procedures and applications including, for example, in conjunction with "open" surgical procedures. As this Detailed Description continues, those skilled in the art will additionally appreciate that the various instruments presented here can be inserted into a body in any way, such as through a natural orifice, through an incision or perforation formed in the tissues, etc. The functional portions or end actuator portions of the instruments can be inserted directly into a patient's body, or they can be inserted through an access device, such as a trocar that has a working channel through which the actuator can be advanced. end and the elongated stem of a surgical instrument.
    [0016] Moving on to the Drawings, in which similar numbers denote similar components in all the various views, FIG. 1 represents a modality of a surgical cutting and stapling instrument 10, which is capable of practicing several exclusive benefits of at least one form of the present invention. Various forms of the surgical instrument 10 are presented in US Patent No. 7,753,904, entitled "Endoscopic Surgical Instrument With a Handle That Can Articulate With Respect to the Shaft", the description of which is incorporated herein, by reference, in its entirety. Thus, details regarding the construction and operation of this instrument that are not necessary to understand the various modalities and forms of the present invention will not be specifically repeated in this document. The surgical instrument shown in FIG. 1 is a motor-driven, or "engine-equipped instrument". As the present Detailed Description continues, the person skilled in the art will understand that several exclusive and innovative aspects of at least some modalities of the invention can also be effectively employed in connection with surgical cutting and stapling instruments that employ mechanical (non-motorized) systems for firing staples and tissue cutting, without departing from the spirit and scope of the present invention. In addition, although various types of instruments have been represented in the present invention with a hand held "cable", the instruments presented in the present invention can be adapted to receive clamping and / or firing movements from a robot or similar device to apply to them , drive movements. Thus, the scope of protection granted to various types of end actuators and cartridges presented in the present invention should not be limited, in any way, to use only with hand-held surgical instruments.
    [0017] As can be seen in FIG. 1, a form of a surgical instrument 10 comprises a cable 6 that has an elongated tube assembly 30 that is operably attached to it, and that is configured to transmit drive movements to an end actuator 12 that is attached to a portion of distal end of the elongated tube assembly 30. End actuator 12 includes a groove 22 that is coupled to support various forms of staple cartridges of the present invention, as will be discussed in more detail below. An anvil 24 is movably supported in relation to the channel 22, in response to opening and closing movements applied to it by various portions of the elongated tube assembly 30.
    [0018] The handle 6 includes a pistol grip 26 towards which a closing trigger 18 can be pivotedly pulled by the doctor, to cause clamping or closing of the anvil 24 towards the clamp channel 22 of the end actuator 12. A trigger trigger 20 is further away from the center, in relation to the closing trigger 18. As shown in FIG. 2, the end actuator 12 may include, in addition to the aforementioned channel 22 and anvil 24, a scalpel actuating element and sliding part 32, a staple cartridge 50 that supports a plurality of unformed staples 90 therein, a helical threaded rod 36 and a bearing 38 which is attached to the structure of the channel 22. The anvil 24 can be pivotally connected to the channel 22 in an adjacent pivot location. In one embodiment, for example, the anvil 24 includes pivot pins 25 projecting laterally at its proximal end, which pivotally engages pivot openings 23 formed near the proximal end of channel 22. When the closing trigger 18 it is actuated, that is, it is pulled by a user of the instrument 10, the rotating pins 25 of the anvil 24 can pivot inside the pivot openings 23 in the channel 22, around the pivot location and to the clamped or closed position. If the clamping of the end actuator 12 is satisfactory, the operator can activate the trigger trigger 20, which activates a motor / transmission (not shown) on the cable 6, which applies rotary movement to the helical thread rod 36 in order to make with the scalpel triggering element / sliding part 32 traveling a path along the channel 22, thus cutting the tissue clamped inside the end actuator 12, and leading the unformed clamps 90 to make formation contact with the bottom side of the anvil 24. For use in the present invention, the term "firing", in relation to the staples, refers to the actions involved in guiding the unformed staples 90 out of their respective staple pockets 92, inside the staple cartridge, and to contact formation with a corresponding portion of the anvil. As this Detailed Description proceeds, however, the reader will understand that at least some of the unique and innovative aspects of the various modalities of the invention can be advantageously employed in connection with a variety of other surgical staplers and surgical stapling instruments including those surgical stapling units configured for use with so-called disposable loading units, such as those devices featured in US patent application publication No. 2006/0011699 A1, entitled "Surgical Stapler With Universal Articulation and Tissue Pre-Clamp", the description of which is here incorporated in its entirety, as a reference. Consequently, the scope of protection granted to the various modalities of the present invention should not be limited to use with a specific type of surgical instrument and / or end actuator.
    [0019] After the scalpel actuator / sliding part 32 has been driven to the distal end of the staple cartridge 50, the physician releases the trigger trigger 20 to allow it to return to an open position, which will result in application of a rotating retraction movement to the scalpel / sliding part actuating element 32 to cause it to move proximally to an initial position. Once the scalpel actuator / sliding part 32 has been moved to an initial position outside the staple cartridge 50, the clinician can unlock the closing trigger 18 by means of a release button 30 on the handle, to allow the closing trigger 18 moves to the open position and thus causes the anvil 24 to rotate to open and release the cut and stapled fabric.
    [0020] In the modalities represented in FIGS. 3 and 4, the staple cartridge 50 includes a cartridge body 51 that supports a plurality of unformed staples 90 therein. The cartridge body 51 has a holder 53 which has, in its interior, a centrally arranged slot 56 that divides the holder 53 into a first portion of the holder 54 and a second portion of the holder 55. The slot 56 accommodates the scalpel-triggering element / sliding piece 32 (FIG. 2) as it is driven longitudinally inside the cartridge body 51. In general, the slot 56 extends from a proximal end 57 to a distal end 58 of the cartridge body 51.
    [0021] In various modalities the measuring means, generally represented as 60, are in at least one of the staple cartridge 50 and the anvil 24. In the embodiment shown in FIGS. 3 and 4, for example, measuring means 60 comprise a first series of measurement signals 62 on the first portion of the support 54, adjacent to a first side edge 59 thereof. In various embodiments, the first series of measurement signals 62 comprises a series of graduated measurement signals 63 that are separated by a predetermined distance. The predetermined distance can correspond to a mark 64 that has a color that differs from the color of the holder 53. For example, for a staple cartridge 50 with a staple line length of 30 mm, the first series of measurement signals can be extend, for example, from 0 mm to 30 mm or 32.5 mm, as shown. That is, each black mark and each white space between them can be approximately 2.5 mm long. Other forms of graduated measurement signals (for example, a segment of a measurement scale, etc.) can be used.
    [0022] Furthermore, in the embodiment shown in FIG. 3, the measurement means 60 further comprises a second series of measurement signals 66 on the second portion of the support 55 adjacent to a second side edge 59 'thereof. In various embodiments, the second series of measurement signals 66 comprises a series of graduated measurement signals 67 that are separated by a predetermined distance. The predetermined distance may correspond to a mark 68 that has a color that differs from the color of the holder 53. The color of mark 68 may or may not correspond to the color of mark 64. The length of each mark 68 may correspond to the length of each marking 64. Other forms of graduated measurement signals (for example, a segment of a measurement scale in millimeters and / or inches, etc.) can be used. In other embodiments, only a series of measurement signals is provided. In at least one mode, the series of measurement signals only performs one measurement function. That is, the measurement signals in at least one mode comprise signals that do not perform any other function on the staple cartridge and / or the anvil, other than offering the user a means to assess the size of a blood vessel 80 clamped between the support 53 and the underside of the anvil 24. See, for example, FIGS. 4 and 5. Those skilled in the art will understand that these provisions of measurement signals 62 and 66 allow the physician to assess the diameter or other dimension of the tissue that is clamped on the end actuator 12, by observing said end actuator 12 from above position (as shown, for example, in FIGS. 5 and 6). In the embodiment shown in FIG. 6, the series of measurement signals 62 and 66 are arranged on the anvil 24. As in the embodiment described above, only one of the series of measurement signals on the anvil 24 can be used. The series of measurement signals can substantially cover the the entire upper surface of the anvil 24, or only portions thereof.
    [0023] FIG. 7 depicts another embodiment of the staple cartridge 150 that is substantially identical to the staple cartridge 50 described above, except for the differences discussed below. Staple cartridge 150 includes a cartridge body 151 that supports a plurality of non-formed staples in the staple pockets 192 therein. The cartridge body 151 has a holder 153 which has, in its interior, a centrally arranged slot 156 that divides the holder 153 into a first portion of the holder 154 and a second portion of the holder 155. In this embodiment, the measuring means 60 comprise a marking forming material 190 on support 153. During use, after blood vessel 80 has been clamped between anvil 24 and cartridge 150, as shown in FIG. 9, the portion 191 of the marking-forming material 190 that has been compressed by the fabric changes color, hue or tone (e.g., a darker shade of color) so that the portion of the marking-forming material 190 that has been compressed or that it merely came into contact with the fabric can be distinguished from portions of the marking forming material 190 that have not been compressed or otherwise touched by the pinched fabric. This provision thus provides the physician with feedback that could be used to assess the transected blood vessel for hemostatic purposes. In addition, this provision provides an indication of where the tissue was in the cartridge holder, for production research investigations. In addition, this arrangement also provides the user with an indication of where the clips were fired directly at the anvil, without penetrating through the fabric.
    [0024] In various embodiments, the marking-forming material 190 can be applied as a coating on the cartridge holder. In other embodiments, the marking-forming material 190 may comprise a substrate that is attached to the cartridge holder or to the jaw portion of the shape of the end actuator that has no stapler function. The marking-forming material may comprise, for example, a material containing an indicator that identifies the tissue based on its pH or chemical composition. For example, the marking-forming material 190 may comprise a material that changes color, or that changes tone or hue of the same color, when merely touched by the fabric, without requiring that said fabric be compressed on it.
    [0025] The devices described here can be designed to be discarded after a single use, or they can be designed for use multiple times. In either case, however, the device can 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, the device can be disassembled, and any number of particular parts or parts of the device can be selectively exchanged or removed, in any combination. After cleaning and / or changing private parts, the device can be reassembled for subsequent use in a reconditioning facility or by a surgical team immediately before a surgical procedure. Those skilled in the art will appreciate that the reconditioning of a device can use a variety of techniques for disassembly, cleaning or replacement, and reassembly. The use of such techniques, and the resulting refurbished device are all within the scope of the present application.
    [0026] Preferably, the invention described here will be processed before surgery. First, a new or used instrument is obtained and, if necessary, cleaned. The instrument can then be sterilized. In a sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK pouch. The container and the instrument are then placed in the field of radiation that can penetrate the container, such as gamma radiation, X-rays or high-energy electrons. The radiation kills bacteria on the instrument and the container. The sterile instrument can then be stored in a sterile container. The sterile container keeps the instrument sterile until it is opened at the medical facility.
    [0027] Any patent, publication or other description material, in whole or in part, which is said to be incorporated into the present invention as a reference, is incorporated into the present invention only to the extent that the incorporated materials do not come into effect. conflict with existing definitions, statements or other description material presented in this description. Accordingly, and to the extent necessary, the description as explicitly stated herein replaces any conflicting material incorporated herein by reference. Any material, or portion thereof, that is deemed to be incorporated by reference into the present invention, but which conflicts with definitions, statements, or other description materials existing herein will be incorporated here only to the extent that no conflict will appear between the embedded material and the existing description material.
    [0028] Although this invention has been described as having exemplary designs, the present invention can be further modified within the spirit and scope of the description. It is therefore intended that this application will cover any variations, uses or adaptations of the invention using its general principles. In addition, this application is intended to cover such changes to the present description, as is known or customary practice in the technique to which this invention belongs.
    权利要求:
    Claims (5)
    [0001]
    1. Surgical staple cartridge (50), comprising: a cartridge body (151) operationally supporting within it a plurality of surgical staples, the cartridge body (151) having a proximal end and a distal end, and a support (153) extending between them; and measuring means (60) on the support (153) to determine a size of fabric placed thereon; characterized by the fact that the measuring means (60) comprise means (190) for forming a marking on the support (153) which corresponds to the size of the fabric placed on it when it comes in contact with the fabric.
    [0002]
    2. Surgical staple cartridge (50) according to claim 1, characterized in that the means (190) for forming a marking comprise pressure sensitive material (190) on the support (153).
    [0003]
    3. Surgical staple cartridge (50), according to claim 2, characterized by the fact that the material comprises a pressure sensitive substrate fixed to the support (153).
    [0004]
    4. Surgical staple cartridge (50) according to claim 2 or 3, characterized in that the pressure sensitive material changes color, tone or hue when compressed by the fabric, so that a portion of the material sensitive to pressure that has been compressed by the fabric can be distinguished from portions of the pressure sensitive material that have not been compressed.
    [0005]
    5.-Surgical staple cartridge (50), according to claim 1, characterized by the fact that the means (190) for forming a marking comprise a material that changes color, tone or hue when it comes in contact with without requiring that said fabric be compressed therein.
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    同族专利:
    公开号 | 公开日
    RU2013145918A|2015-04-20|
    WO2012125624A2|2012-09-20|
    CA2829981A1|2012-09-20|
    CN103415262A|2013-11-27|
    AU2012230048A1|2013-09-12|
    AU2012230048B2|2016-08-25|
    BR112013023486A2|2016-12-06|
    WO2012125624A3|2013-05-16|
    JP2014515638A|2014-07-03|
    US20120234895A1|2012-09-20|
    EP2685910A2|2014-01-22|
    CN103415262B|2016-04-06|
    JP6009473B2|2016-10-19|
    RU2607530C2|2017-01-10|
    EP2685910B1|2018-05-30|
    CA2829981C|2019-09-10|
    EP3388000A1|2018-10-17|
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    法律状态:
    2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-10-08| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-09-01| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-11-24| 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 13/03/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US13/048,590|2011-03-15|
    US13/048,590|US20120234895A1|2011-03-15|2011-03-15|Surgical staple cartridges and end effectors with vessel measurement arrangements|
    PCT/US2012/028905|WO2012125624A2|2011-03-15|2012-03-13|Surgical staple cartridges and end effectors with vessel measurement arrangements|
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