专利摘要:
surgical stapler with different staple widths along different circumferences. The present invention relates to an apparatus for stapling fabric which includes a head assembly, an actuator cable in communication with the head assembly, and a staple cartridge. the head assembly is intended to drive a plurality of clamps in response to actuation of the actuator cable. the staple cartridge is in communication with the head assembly. the staple cartridge comprises a first annular apertured ring and a second apertured ring. the first annular apertured ring includes apertures that are a different size than the second annular apertured ring, so that the apertures accommodate clips having different crown lengths. staples can include pads that are configured to provide a larger staple projection area.
公开号:BR112015013158B1
申请号:R112015013158-1
申请日:2013-12-04
公开日:2021-08-03
发明作者:Frederick E. Shelton Iv;John P. Measamer;Johnny H. Alexander Iii;Christopher C. Miller;Jason R. Lesko;James S. Merritt;Tamara S. Vetro Widenhouse
申请人:Ethicon Endo-Surgery, Inc;
IPC主号:
专利说明:

BACKGROUND
[001] In some cases, a surgeon may want to position a surgical instrument through a patient's orifice and use the instrument to adjust, position, secure, and/or interact with tissues within the patient. For example, in some surgical procedures, portions of the gastrointestinal tract may be cut and removed to eliminate unwanted tissue, or for other reasons. Once the desired tissue is removed, the remaining portions may need to be joined. One of the tools for performing these anastomotic procedures is a circular stapler that is inserted through a patient's orifice.
[002] Examples of surgical circular staplers are described in US Patent No. 5,205,459 entitled "Surgical Anastomosis Stapling Instrument", issued April 27, 1993; US Patent No. 5,271,544 entitled "Surgical Anastomosis Stapling Instrument", issued December 21, 1993; US Patent No. 5,275,322, entitled "Surgical Anastomosis Stapling Instrument", issued January 4, 1994; US Patent No. 5,285,945 entitled "Surgical Anastomosis Stapling Instrument", issued February 15, 1994; US Patent No. 5,292,053 entitled "Surgical Anastomosis Stapling Instrument", issued March 8, 1994; US Patent No. 5,333,773 entitled "Surgical Anastomosis Stapling Instrument", issued August 2, 1994; US Patent No. 5,350,104 entitled "Surgical Anastomosis Stapling Instrument", issued September 27, 1994; and US Patent No. 5,533,661 entitled "Surgical Anastomosis Stapling Instrument", issued July 9, 1996. The description of each of the above-cited US patents is incorporated by reference into the present invention. Some of these staplers work to secure layers of fabric, cut through the attached layers of fabric and cause the staples to go through the layers of fabric to substantially join the cut layers of fabric together, close to their cut ends, joining, thus, two ends cut off from an anatomical lumen.
Merely additional examples of surgical staplers are set forth in US Patent No. 4,805,823 entitled "Pocket Configuration for Internal Organ Staplers", issued January 21, 1989; U.S. Patent No. 5,415,334 entitled "Surgical Stapler and Staple Cartridge", issued May 16, 1995; U.S. Patent No. 5,465,895 entitled "Surgical Stapler Instrument", issued November 14, 1995; US Patent No. 5,597,107 entitled "Surgical Stapler Instrument", issued January 28, 1997; US Patent No. 5,632,432 entitled "Surgical Instrument", issued May 27, 1997; US Patent No. 5,673,840 entitled "Surgical Instrument", issued October 7, 1997; US Patent No. 5,704,534 entitled "Articulation Assembly for Surgical Instruments", issued January 6, 1998; U.S. Patent No. 5,814,055 entitled "Surgical Clamping Mechanism", issued September 29, 1998; US Patent No. 6,978,921 entitled "Surgical Stapling Instrument Incorporating an E-Beam Firing Mechanism", issued December 27, 2005; U.S. Patent No. 7,000,818 entitled "Surgical Stapling Instrument Having Separate Distinct Closing and Firing Systems", issued February 21, 2006; U.S. Patent No. 7,143,923 entitled "Surgical Stapling Instrument Having a Firing Lockout for an Unclosed Anvil", issued December 5, 2006; US Patent No. 7,303,108 entitled "Surgical Stapling Instrument Incorporating a Multi-Stroke Firing Mechanism with a Flexible Rack", issued December 4, 2007; US Patent No. 7,367,485 entitled "Surgical Stapling Instrument Incorporating a Multistroke Firing Mechanism Having a Rotary Transmission", granted May 6, 2008; US Patent No. 7,380,695 entitled "Surgical Stapling Instrument Having a Single Lockout Mechanism for Prevention of Firing", granted June 3, 2008; US Patent No. 7,380,696 entitled "Articulating Surgical Stapling Instrument Incorporating a Two-Piece E-Beam Firing Mechanism", granted June 3, 2008; US Patent No. 7,404,508 entitled "Surgical Stapling and Cutting Device", issued July 29, 2008; U.S. Patent No. 7,434,715 entitled "Surgical Stapling Instrument Having Multistroke Firing with Opening Lockout", issued October 14, 2008; and US Patent No. 7,721,930 entitled "Disposable Cartridge with Adhesive for Use with a Stapling Device", issued May 25, 2010. The description of each of the above-cited US patents is incorporated herein by reference. Although the aforementioned surgical staplers are described as being used in endoscopic procedures, it should be understood that these surgical staplers can also be used in open procedures and/or other non-endoscopic procedures.
[004] Although various types of surgical stapling instruments and associated components have been manufactured and used, it is believed that no one prior to the inventor(s) has manufactured or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS
[005] Although the specification concludes with claims that specifically indicate and distinctly claim this technology, it is believed that this technology will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which the same numbers of reference identify the same elements and where:
[006] Figure 1 represents a side elevation view of an example of a surgical instrument for circular stapling;
[007] Figure 2A represents an enlarged longitudinal cross-sectional view of an example of a clamping head assembly of the instrument of Figure 1, showing an exemplary anvil in an open position;
[008] Figure 2B represents an enlarged longitudinal cross-sectional view of the stapling head assembly of Figure 2A, showing the anvil in a closed position;
[009] Figure 2C represents an enlarged longitudinal cross-sectional view of the stapling head assembly of Figure 2A, showing an example of a staple and blade driver in a fired position;
[0010] Figure 3 represents an enlarged partial cross-sectional view of an exemplary clamp formed against the anvil;
[0011] Figure 4A represents an enlarged side elevation view of an exemplary actuator cable assembly, of the surgical instrument of Figure 1, with a portion of the body removed, showing a trigger in an unfired position and a locking feature in a locked position;
[0012] Figure 4B represents an enlarged side elevation view of the actuator cable assembly of Figure 4A, showing the trigger in a fired position and the locking feature in an unlocked position;
[0013] Figure 5 represents an enlarged partial perspective view of an exemplary indicator assembly of the surgical instrument of Figure 1, showing an indicator window and an indicator lever;
[0014] Figure 6 represents a diagrammatic view of the indicator window of Figure 5, showing an exemplary indicator bar and corresponding exemplary clip representations;
[0015] Figure 7 is an enlarged perspective view of an exemplary staple cartridge for use with the staple head assembly of Figure 2A;
[0016] Figure 8 is a side elevation view of a large exemplary staple for use with the staple cartridge of Figure 7;
[0017] Figure 9 is a side elevation view of an exemplary medium staple for use with the staple cartridge of Figure 7;
[0018] Figure 10 is a side elevation view of a small exemplary staple for use with the staple cartridge of Figure 7;
[0019] Figure 11 represents an enlarged top view of the staple cartridge of Figure 7 with large staples, medium staples and small staples loaded in the staple cartridge;
[0020] Figure 12 represents an enlarged perspective view of an exemplary clamp support element;
[0021] Figure 13 represents a side elevation view of an exemplary external clamp equipped with the clamp support element of Figure 12;
[0022] Figure 14 represents a side elevation view of an exemplary medium clamp equipped with a medium clamp support element;
[0023] Figure 15 represents a side elevation view of an exemplary internal clamp equipped with a small clamp support element;
[0024] Figure 16 represents an enlarged top view of an exemplary staple cartridge loaded with large staples, medium staples and small staples, equipped with a staple support element;
[0025] Figure 17 is an enlarged top view of an alternative exemplary clamp support member with longitudinally extending tabs;
[0026] Figure 18 represents an enlarged top view of an alternative exemplary clamp support member with transversely extending tabs;
[0027] Figure 19 represents an enlarged top view of an alternative exemplary clamp support element with longitudinally and transversely extending tabs; and
[0028] Figure 20 represents a perspective view of the staple support element of Figure 19 in an exemplary staple cartridge.
[0029] The drawings are not intended to be limiting in any way, and it is contemplated that various modalities of the technology may be carried out in a variety of other ways, including those not necessarily represented in the drawings. The attached drawings which form a part of the descriptive report illustrate various aspects of the present technology, and together with the description serve to explain the principles of the technology. It is understood, however, that this technology is not limited precisely to the provisions shown. DETAILED DESCRIPTION
[0030] The following description of some examples of the technology should not be used to limit its scope. Other examples, elements, aspects, modalities and advantages of the technology will become evident to those skilled in the art with the following description, which is through illustrations, one of the best ways contemplated for carrying out the technology. As will be understood, the technology described here is capable of other different and obvious aspects, all without departing from the technology. Consequently, the drawings and descriptions are to be considered as illustrative in nature and not restrictive.I. Overview of the exemplary surgical instrument for circular stapling
[0031] Figures 1 to 6 represent an example of circular surgical stapling instrument 10, having a stapling head assembly 20, a rod assembly 60 and an actuator cable assembly 70, each of which will be described in detail below. Stem assembly 60 extends distally from actuator cable assembly 70, and clamping head assembly 20 is coupled to a distal end of stem assembly 60. In summary, actuator cable assembly 70 functions in such a way as to activating a staple driver 24 of the staple head assembly 20 to drive a plurality of staples 66 out of the staple head assembly 20. To form finished staples, staples 66 are bent by an anvil 40 which is secured to the distal end of instrument 10. Consequently, tissue 2 shown in Figures 2A to 2C can be stapled using instrument 10.
[0032] In the present example, the instrument 10 comprises a closing system and a triggering system. The closure system comprises a trocar 38, a trocar actuator 39 and a rotary knob 98. An anvil 40 can be coupled to a distal end of the trocar 38. The rotary knob 98 is intended to longitudinally translate the trocar 38 with respect to the assembly of clipping head 20, thus translating the anvil 40 when it is coupled to the trocar 38, to clip the tissue between the anvil 40 and the clipping head assembly 20. The firing system comprises a trigger 74, a trigger assembly of trigger 84, a drive actuator 64, and a staple driver 24. The staple trigger 24 includes a knife 36 configured to cut tissue when the staple trigger 24 is actuated longitudinally. In addition, clips 66 are positioned distally to a plurality of clip drive elements 30 of clip driver 24 so that clip driver 24 also drives clips 66 distally when clip driver 24 is actuated longitudinally. . Thus, when the trigger 74 is actuated and the trigger drive assembly 84 actuates the clamp driver 24 via the drive actuator 64, the knife 36 and elements 30 substantially simultaneously cut tissue 2 and drive the staples 66 distally to the staple head assembly 20 and into tissue. The components and functionalities of the closing system and the triggering system will now be described in more detail. A. Anvil Example
[0033] As shown in Figures 1 to 2C, the anvil 40 is selectively attachable to the instrument 10 to provide a surface against which the clips 66 can be folded to staple the material contained between the clipping head assembly 20 and the anvil 40. The anvil 40 of the present example is selectively attachable to a trocar or sharpened rod 38, which extends distally to the stapling head assembly 20. Referring to Figures 2A through 2C, the anvil 40 is selectively attachable by coupling a proximal shaft 42 of anvil 40 to a distal tip of trocar 38. Anvil 40 comprises a generally circular anvil head 48 and a proximal shaft 42 extending proximally from the incus head 48. In the example shown, the proximal shaft 42 comprises a tubular member 44 having resiliently slanted retaining tabs 46 to selectively couple the anvil 40 to the trocar 38, although this is is merely optional, and it should be understood that other retention features for attaching anvil 40 to trocar 38 may also be used. For example, C-clips, staples, threads, pins, stickers, etc. may be employed to couple the incus 40 to the trocar 38. Furthermore, although the incus 40 is described as selectively attachable to the trocar 38, in some versions the proximal rod 42 may include a one-way coupling feature so that, once fixed, the anvil 40 cannot be removed from the trocar 38. Merely exemplary unidirectional elements include barbs, unidirectional snap buttons, tweezers, collars, flaps, bands, etc. Of course still other configurations for coupling anvil 40 to trocar 38 will be apparent to one of skill in the art in view of the teachings of the present invention. For example, trocar 38 may instead be a hollow shaft, and proximal shaft 42 may comprise a sharpened shaft that can be inserted into the hollow shaft.
[0034] The anvil head 48 of the present example comprises a plurality of clip-forming pockets 52 formed on a proximal face 50 of the anvil head 48. Consequently, when the anvil 40 is in the closed position and the clips 66 are driven outward from the staple head assembly 20 and into the staple forming pockets 52, as shown in Figure 2C, the legs 68 of the staples 66 are bent to form finished staples. It should be understood that the staple forming pockets 52 are merely optional, and may be omitted in some versions.
[0035] With the anvil 40 as a separate component, it should be understood that the anvil 40 can be inserted and secured to a portion of tissue 2 prior to being coupled to the stapling head assembly 20. By way of example only, the anvil 40 may be inserted and secured to a first tubular tissue portion 2, while the instrument 10 is inserted and secured to a second tubular tissue portion 2. For example, the first tubular tissue portion 2 may be sutured to or around a incus portion 40, and the second tubular tissue portion 2 can be sutured to or around trocar 38.
[0036] As shown in Figure 2A, the incus 40 is then coupled to the trocar 38. The trocar 38 of the present example is shown in a more actuated distal position. This extended position of the trocar 38 can provide a larger area to which tissue 2 can be attached prior to attachment of the incus 40. In addition, the extended position of the trocar 38 can also provide easier attachment of the incus 40 to the trocar 38 The trocar 38 additionally includes a tapered distal tip. This tip may be capable of piercing through tissue and/or assisting in the insertion of the incus 40 into the trocar 38, although the tapered distal tip is merely optional. For example, in other versions the trocar 38 may have a non-piercing tip. Additionally, or alternatively, the trocar 38 may include a magnetic portion (not shown) that can attract the incus 40 toward the trocar 38. Of course, other configurations and arrangements for the incus 40 and the trocar 38 will be apparent to those skilled in the art. technique, in view of the teachings contained herein.
[0037] When the incus 40 is coupled to the trocar 38, the distance between a proximal face of the incus 40 and a distal face of the clamping head assembly 20 defines a span distance d. The trocar 38 of the present example is translatable longitudinally with respect to the clamping head assembly 20 by means of an adjustment knob 98 located at a proximal end of the actuator cable assembly 70, as will be described in more detail below. Consequently, when the anvil 40 is coupled to the trotter 38, the rotation of the adjusting knob 98 extends or reduces the span distance d by driving the anvil 40 relative to the clamping head assembly 20. For example As shown sequentially in Figures 2A to 2B, the anvil 40 is shown acting proximally to the actuator cable assembly 70, from an initial open position to a closed position, thus reducing the span distance between the two pieces of fabric 2 to be joined. When the span distance d is placed within a predetermined range, the stapling head assembly 20 can be fired, as shown in Figure 2C, to staple and cut the fabric 2 between the anvil 40 and the stapling head assembly 20. Stapling head assembly 20 staples and cuts fabric 2 when a user turns a trigger 74 of actuator cable assembly 70, as will be described in more detail below.
[0038] As noted above, the span distance d corresponds to the distance between the anvil 40 and the stapling head assembly 20. When instrument 10 is inserted into a patient, this span distance d may not be easily visible. Accordingly, a movable indicator bar 110, shown in Figures 5 to 6, is arranged to be visible through an indicator window 120 positioned opposite the trigger 74. The indicator bar 110 is intended to move in response to rotation of the knob. setting 98 so that the position of the indicator bar 110 is representative of the span distance d. As shown in Figure 6, the indicator window 120 further comprises a scale 130 indicating that the anvil span is in a desired operating range (e.g., a green colored region or "green zone") and a representation of corresponding staple compression at each end of scale 130. By way of example only, as shown in Figure 6, a first staple image 132 represents a large staple height, while a second staple image 134 represents a small staple height. Consequently, a user can view the position of the coupled anvil 40 relative to the clamping head assembly 20 via the indicator bar 110 and the scale 130. The user can then adjust the positioning of the anvil 40 via the adjustment knob 98 as needed.
[0039] Referring again to Figures 2A to 2C, a user sutures a portion of the fabric 2 around the tubular element 44 so that the head of the anvil 48 is situated on a portion of the fabric 2 to be stapled. When tissue 2 is secured to anvil 40, retaining tabs 46 and a portion of tubular member 44 protrude from tissue 2 so that the user can attach anvil 40 to trocar 38. With tissue 2 attached to tissue 2 trocar 38 and/or the other portion of the stapling head assembly 20, the user attaches the anvil 40 to the trocar 38 and drives the anvil 40 proximally toward the stapling head assembly 20 to reduce the gap distance d. When the instrument 10 is within the operating range, the user then staples the ends of the fabric 2, thus forming a substantially contiguous tubular portion of the fabric 2.
The anvil 40 may be further constructed in accordance with at least some of the teachings of US Patent No. 5,205,459; US Patent No. 5,271,544; US Patent No. 5,275,322; US Patent No. 5,285,945; US Patent No. 5,292,053; US Patent No. 5,333,773; US Patent No. 5,350,104; U.S. Patent No. 5,533,661, the disclosures of which are incorporated herein by reference; and/or in other embodiments, as will be apparent to one skilled in the art in view of the teachings of the present invention. B. Example Stapling Head Assembly
[0041] The clamping head assembly 20 of the present example is coupled to a distal end of the rod assembly 60 and comprises a tubular housing 22 housing a sliding clamp driver 24 and a plurality of clamps 66 contained in the clamp pockets 32. Clamps 66 and clip pockets 32 are disposed in a circular array around tubular housing 22. In the present example, clips 66 and clip pockets 32 are disposed in a pair of concentric annular rows of clips 66 and clip pockets 32. The driver clamp 24 is intended to act longitudinally within tubular housing 22 in response to rotation of trigger 74 of actuator handle assembly 70. As shown in Figures 2A to 2C, clamp actuator 24 comprises a flared cylindrical member having a trocar opening 26, a central recess 28 and a plurality of elements 30 circumferentially disposed around the central recess 28 and extending distally. with respect to rod assembly 60. Each element 30 is configured to contact, and engage with, a corresponding clip 66 of the plurality of clips 66 in clip pockets 32. Consequently, when clip actuator 24 is actuated distal to the actuator cable assembly 70, each element 30 drives a corresponding clip 66 out of its clip pocket 32 through a clip opening 34 formed in a distal end of the tubular housing 22. extends from the staple driver 24, the plurality of staples 66 are driven out of the staple head assembly 20 at substantially the same time. When the anvil 40 is in the closed position, the staples 66 are guided into staple-forming pockets 52 to bend the legs 68 of the staples 66, thereby stapling the material located between the anvil 40 and the staple head assembly 20. Figure 3 represents a merely exemplary staple 66 carried by an element 30 in a staple-forming pocket 32 of the anvil 40 for flexing the legs 68.
[0042] The clip driver 24 additionally includes a cylindrical knife 36 that is coaxial to the opening of the trocar 26 and insertion of the clip pockets 32. In the present example, the cylindrical knife 36 is disposed within the central recess 28 to translate distally with the driver. of clamp 24. When anvil 40 is secured to trocar 38, as described above, anvil head 48 provides a surface against which cylindrical knife 36 cuts material contained between anvil 40 and clamping head assembly 20. In some versions, the anvil head 48 may include a recess (not shown) for the cylindrical knife 36 to help cut material (e.g., by providing a cooperative cutting edge). Additionally, or alternatively, the anvil head 48 may include one or more opposing cylindrical knives (not shown) offsetting the cylindrical knife 36 so that it can provide a scissor-like cutting action. Still other configurations will be evident to those skilled in the art in view of the teachings contained herein. The stapling head assembly 20 thus functions both to staple and to cut the fabric 2 substantially simultaneously in response to actuation by the actuator cable assembly 70.
[0043] Logically, the clamping head assembly 20 can be further constructed in accordance with at least some of the teachings of US Patent No. 5,205,459; US Patent No. 5,271,544; US Patent No. 5,275,322; US Patent No. 5,285,945; US Patent No. 5,292,053; US Patent No. 5,333,773; US Patent No. 5,350,104; U.S. Patent No. 5,533,661, the disclosures of which are incorporated herein by reference; and/or in other embodiments, as will be apparent to one skilled in the art in view of the teachings of the present invention.
[0044] As noted earlier, the staple driver 24 includes a trocar opening 26. The trocar opening 26 is configured to allow the trocar 38 to slide longitudinally with respect to the clamping head assembly 20 and/or stem assembly 60 As shown in Figures 2A to 2C, the trocar 38 is coupled to a trocar actuator 39 so that the trocar 38 can be actuated longitudinally by rotating the rotary knob 98, as will be described in more detail below with reference to the assembly. of actuator cable 70. In the present example, the trocar actuator 39 comprises an elongated, relatively rigid rod coupled to the trocar 38, although this is merely optional. In some versions, actuator 39 may comprise a longitudinally rigid material while allowing lateral flexion so that portions of instrument 10 can be selectively flexed or curved during use; or instrument 10 may include a previously prepared bent rod assembly 60. A merely exemplary material is nitinol. When the anvil 40 is coupled to the trocar 38, the trocar 38 and the anvil 40 are translatable via the actuator 39 to adjust the gap distance d between the anvil 40 and the clamping head assembly 20. Yet other additional configurations for the actuator 39 to actuate the trotter 38 longitudinally will be evident to the person skilled in the art, in view of the teachings contained herein. C. Rod Assembly Example
[0045] Stapling head assembly 20 and trocar 38 are positioned at a distal end of stem assembly 60, as shown in Figures 2A through 2C. The rod assembly 60 of the present example comprises an outer tubular member 62 and a drive actuator 64. The outer tubular member 62 is coupled to the tubular sheath 22 of the clamping head assembly 20 and to a body 72 of the actuator cable assembly 70 , thus offering mechanical support for the actuating components contained therein. The proximal end of the trigger actuator 64 is coupled to a trigger trigger assembly 84 of the actuator cable assembly 70, described below. The distal end of actuating actuator 64 is coupled to clamp actuator 24 so that rotation of trigger 74 longitudinally actuates clamp actuator 24. As shown in Figures 2A to 2C, actuating actuator 64 comprises a tubular member having a longitudinal axis open so that the actuator 39 coupled to the trocar 38 can actuate longitudinally within and relative to the actuating actuator 64. It should, of course, be understood that other components may be disposed within the actuating actuator 64, as will be evident to the person skilled in the art in view of the teachings contained herein.
The rod assembly 60 may be further constructed in accordance with at least some of the teachings of US Patent No. 5,205,459; US Patent No. 5,271,544; US Patent No. 5,275,322; US Patent No. 5,285,945; US Patent No. 5,292,053; US Patent No. 5,333,773; US Patent No. 5,350,104; U.S. Patent No. 5,533,661, the disclosures of which are incorporated herein by reference; and/or in other embodiments, as will be apparent to one skilled in the art in view of the teachings of the present invention. D. Example of Actuator Cable Assembly
[0047] Now, referring to Figures 4A to 5, the cabo-actuator assembly 70 comprises a body 72, a trigger 74, a lockout feature 82, a trigger drive assembly 84 and a trocar drive assembly 90. The trigger 74 of the present example is pivotally mounted to the body 72 and is coupled to the trigger drive assembly 84 so that the trigger drive 74 rotates from an unfired position (shown in Figure 4A) to a fired position (shown in Figure 4B) actuate the drive actuator 64 described above. A spring 78 is coupled to the body 72 and the trigger 74 to bias the trigger 74 toward the unfired position. The locking feature 82 is a pivoting element that is coupled to the body 72. In a first, locked position, the locking feature 82 is pivoted up and away from the body 72 so that the locking feature 82 engages the trigger. 74 and mechanically resists triggering of trigger 74 by a user. In a second unlocked position, as shown in Figures 1 and 4B, the locking feature 82 is rotated downward so that the trigger 74 can be actuated by the user. Consequently, with the locking feature 82 in the second position, the trigger 74 can engage a trigger drive assembly 84 to trigger the instrument 10.
[0048] As shown in Figures 4A and 4B, the trigger drive assembly 84 of the present example comprises a sliding trigger carriage 86 engaged with a proximal end of the drive actuator 64. The carriage 86 includes a set of tabs 88 at one end proximal of carriage 86 to retain and engage a pair of trigger arms 76 extending from trigger 74. Consequently, when trigger 74 is rotated, carriage 86 is longitudinally driven and transfers longitudinal movement to drive actuator 64 In the example shown, carriage 86 is fixedly coupled to the proximal end of drive actuator 64, although this is merely optional. Indeed, in a merely alternative example, carriage 86 may simply be in a position abutting drive actuator 64, while a distal spring (not shown) tilts drive actuator 64 proximally with respect to actuator cable assembly 70.
[0049] Trigger actuation assembly 84 may be additionally constructed in accordance with at least some of the teachings of US Patent No. 5,205,459; US Patent No. 5,271,544; US Patent No. 5,275,322; US Patent No. 5,285,945; US Patent No. 5,292,053; US Patent No. 5,333,773; US Patent No. 5,350,104; U.S. Patent No. 5,533,661, the disclosures of which are incorporated herein by reference; and/or in other embodiments, as will be apparent to one skilled in the art in view of the teachings of the present invention.
[0050] The body 72 also houses a trocar drive assembly 90 configured to drive the trocar 38 longitudinally in response to the rotation of the adjustment knob 98. As best shown in Figures 4A to 5, the trocar drive assembly 90 of the The present example comprises the adjustment knob 98, a splined stem 94 and a sleeve 92. The splined stem 94 of the present example is located at a distal end of the trocar actuator 39, although it should be understood that the splined stem 94 and the actuator of Trocar 39 may alternatively be separate components that engage to impart longitudinal movement. Adjustment knob 98 is pivotally supported by the proximal end of body 72 and functions to rotate sleeve 92 which is engaged with splined rod 94 by means of an inner tab (not shown). The splined rod 94 of the present example comprises a continuous groove 96 formed in the outer surface of the splined rod 94. Consequently, when the adjustment knob 98 is rotated, the inner tab moves within the groove 96 and the splined rod 94 is actuated longitudinally with respect to sleeve 92. As the splined rod 94 is situated at the distal end of the trocar actuator 39, turning the adjustment knob 98 in a first direction advances the trocar actuator 39 distally with respect to the actuator handle assembly 70. Consequently , the gap distance d between the anvil 40 and the clamping head assembly 20 is increased. By turning the adjustment knob 98 in the opposite direction, the trocar actuator 39 is actuated proximally to the actuator cable assembly 70 to reduce the span distance d between the anvil 40 and the clamping head assembly 20. Thus, the trocar driving assembly 90 is intended to drive the trocar 38 in response to the b swivel adjustment knob 98. Of course, other configurations for the shift drive assembly 90 will be apparent to one of skill in the art in view of the teachings contained herein.
The groove 96 of the present example comprises a plurality of different portions 96A, 96B, 96C having a different range or number of grooves per axial distance. The present groove 96 is divided into a distal portion 96A, a middle portion 96B and a proximal portion 96C. As shown in Figure 5, a distal portion 96A comprises a fine pitch or a high number of grooves along a short axial distance from the splined rod 94 so that a large number of rotations of adjustment knob 98 are required to travel the short axial distance. The middle portion 96B comprises a section with comparably thicker gaps or with fewer grooves per axial distance so that relatively few rotations are needed to traverse a long axial distance. Consequently, the span distance d can be quickly reduced by relatively few rotations of the adjustment knob 98. The proximal portion 96C of the present example is substantially similar to the distal portion 96A and comprises a thin gap or a high number of grooves per a short axial distance from the splined rod 94 so that a large number of rotations are required to traverse the short axial distance. The proximal portion 96C of the present example is positioned on the sleeve 92 when the anvil 40 is substantially close to the clamping head assembly 20 so that an indicator bar 110 moves within the indicator window 120 along the scale 130 to indicate the span. the anvil is within a desired operating range as will be described in detail below. Consequently, when the tab is within the proximal portion 96C of the groove 96, each rotation of the adjustment knob 98 can reduce the gap distance d to a small amount to provide a fine adjustment.
[0052] The operating assembly of the trocar 90 can be further constructed in accordance with at least some of the teachings of US Patent No. 5,205,459; US Patent No. 5,271,544; US Patent No. 5,275,322; US Patent No. 5,285,945; US Patent No. 5,292,053; US Patent No. 5,333,773; US Patent No. 5,350,104; U.S. Patent No. 5,533,661, the disclosures of which are incorporated herein by reference; and/or in other embodiments, as will be apparent to one skilled in the art in view of the teachings of the present invention.
[0053] In the example shown in Figures 4A to 4B, a U-shaped cleat 100 is attached to an intermediate portion of the trocar actuator 39 located distally from the splined rod 94. The U-shaped cleat 100 engages with a body portion 72 to substantially prevent the trocar actuator 39 from rotating about its axis when the adjustment knob 98 is rotated. The U-shaped cleat 100 further includes an elongated slot 102 on each of its opposite sides for receiving a fastening element, such as a screw, bolt, pin, cleat, etc., to selectively adjust the longitudinal position of the elongated slot 102 of the U-shaped loop 100 with respect to the trocar actuator 39, for the purpose of calibrating the indicator bar 110 with respect to the scale 130.
[0054] As shown in Figure 5, the actuator cable assembly 70 further includes an indicator bracket 140 configured to engage and rotate an indicator 104. The indicator bracket 140 of the present example is slidable relative to the body 72 along a pair of slits formed in body 72. Indicator bracket 140 comprises a rectangular plate 144, indicator arm 146, and angled flange 142. Angle flange 142 is formed at the proximal end of rectangular plate 144, and includes an aperture (not shown) to be slidably mounted on the trocar actuator 39 and/or the splined rod 94. A coil spring 150 is interposed between the flange 142 and a protrusion 152 to bias the flange 142 against the U-shaped loop 100. Consequently , when the U-shaped clip 100 acts distally with the Trocar Actuator 39 and/or the splined rod 94, the coil spring 150 forces the indicator bracket 140 to move distally with the U-shaped clip 100. In addition d this, the U-shaped clamp 100 forces the indicator bracket 140 proximally to the protrusion 152, when the trocar actuator 39 and/or the splined rod 94 move proximally, thus compressing the coil spring 150. Of course It should be understood that, in some versions, the indicator bracket 140 may be fixedly attached to the trocar actuator 39 and/or the splined rod 94.
[0055] In the present example, a portion of the locking feature 82 is in a boundary position with respect to a surface 141 of the indicator bracket 140, when said indicator bracket 140 is in a longitudinal position that does not correspond to when the anvil span is within a desired operating range (eg a green colored region or "green zone"). When the anvil span is within a desired operating range (eg, a green colored region or "green zone"), the indicator bracket 140 thins to provide a pair of spans 145 on either side of an indicator arm 146 which allows the locking feature 82 to rotate, thereby releasing the trigger 74. Consequently, the locking feature 82 and the indicator bracket 140 can substantially prevent a user from releasing and operating the trigger 74 until the anvil 40 is in a range of default operation. It should be understood, of course, that lockout feature 82 may be omitted entirely in some versions.
[0056] This operating range may be visually communicated to the user by means of an indicator bar 110 of an indicator 104 shown against a scale 130, described briefly above. At the distal end of index bracket 140 is a distally extending index arm 146 that terminates in a laterally extending finger 148 to control movement of index 104. Index arm 146 and finger 148, best shown in Figure 5, are configured to engage. to a tab 106 of indicator 104 so that indicator 104 is rotated when indicator bracket 140 is actuated longitudinally. In the present example, indicator 104 is pivotally coupled to body 72 at a first end of indicator 104, although this is merely optional, and other pivot points of indicator 104 will be apparent to one of ordinary skill in the art in view of the teachings contained herein. . An indicator bar 110 is positioned at the second end of the indicator 104 so that the indicator bar 110 moves in response to the actuation of the indicator bracket 140. Consequently, as discussed above, the indicator bar 110 is displayed through an indicator window 120 against a scale 130 (shown in Figure 6) to show the relative span distance d between the anvil 40 and the clamping head assembly 20.
[0057] Logically, the indicator bracket 140, the indicator 104, and/or the actuator cable assembly 70 can be further constructed in accordance with at least some of the teachings of US patent No. 5,205,459; US Patent No. 5,271,544; US Patent No. 5,275,322; US Patent No. 5,285,945; US Patent No. 5,292,053; US Patent No. 5,333,773; US Patent No. 5,350,104; U.S. Patent No. 5,533,661, the disclosures of which are incorporated herein by reference; and/or in other embodiments, as will be apparent to one skilled in the art in view of the teachings of the present invention. II. Exemplary staple cartridge
[0058] During operation of instrument 10, a staple cartridge 200 may be used to hold staples 66 in preparation for firing a plurality of concentrically arranged rings. In some cases, each ring of staples 66 within the staple cartridge 200 may have an equal number of staples 66, even when the rings vary in radius, by varying the total width of each staple within a ring of staples. It will be appreciated that varying the widths of clamps 66 can enable an inner ring of concentric rings of clamps 66 to be more compacted than an outer ring. It will also be appreciated that providing an equal number of clips 66 with each concentric ring may allow for better hemostasis as the clips 66 are driven into tissue. Other desirable traits can also be brought about. Figure 7 shows an exemplary staple cartridge 200 operable for use with instrument 10, in which three rings of staples include the same number of staples in each ring. Generally speaking, the staple cartridge 200 is intended to hold a plurality of staples 250, 252, 254 (shown in Figures 8 to 10) of different shapes and sizes, as will be described in more detail below. In some cases, staples 250, 252, 254 may also be positioned within staple cartridge 200 with other supplements and/or components that can be configured to fire with staples 250, which will be discussed further below. Of course, it will be understood that staples 250, 252, 254 can be loaded into staple cartridge 200 without additional components.
[0059] The staple cartridge 200 comprises an upper ring204 and a lower body 202. In the exemplary version, the staple cartridge 200 has an elongated ring shape, but it will be understood that the staple cartridge 200 may have any suitable shape as it would be. evident to one skilled in the art in view of the teachings of the present invention. The top ring 204 defines a plurality of clamp openings 210 that surround the top ring 204. The clamp openings 210 have an elongated hexagonal shape that has rounded ends, as seen in Figure 7 and Figure 11. It should be understood that the openings of clip 210 may have other shapes such as an elongated rectangle, elliptical, circular, square, slit shape, or any other shape suitable for receiving one or more clips as would be apparent to one of skill in the art in view of the teachings of the present invention.
[0060] As also seen in Figures 7 and 11, three rings with clamp openings 210 surround the top ring 204. An outer ring 214, a center ring 216 and an inner ring 218 make up the annular rows of the clamp openings 210. The ring The outer ring 214 of the clamp openings 210 has the largest clamp openings 210 and, as a result, it is to be understood that the outer ring 214 has the least density of or the least number of clamp openings 210. The inner ring 218 has the smallest openings 210, so that inner ring 218 has the highest density of clip openings 210. Center ring 216 is positioned between outer ring 214 and inner ring 218. Center ring 216 includes clip openings 210 sized between the openings. of clamp 210 of outer ring 214 and inner ring 218. As a result, center ring 216 has a clamp opening density 210 between outer ring 214 and inner ring 218. Outer ring 214, center ring 216 and inner ring 218 are positioned concentrically around an opening 212 defined by the staple cartridge 200. In some versions, the number of clamp openings 210 of the inner ring 218 is equal to the number of clamp openings 210 of the center ring 216 and is equal to the number of openings of clamp openings 210 from outer ring 214. However, it should be understood that the number of clamp openings 210 may also be varied between rings 214, 216, 218 in some versions. In addition, outer ring 214, center ring 216 and inner ring 218 are positioned so that clamp openings 210 of center ring 216 are interlocked between clamp openings 210 of outer ring 214 and inner ring 218. It is understood that other suitable configurations of positioning the outer ring 214, the center ring 216 and the inner ring 218 may be used as would be apparent to one of skill in the art. For example, although center ring 216 roughly divides the distance between inner ring 218 and outer ring 214, it should be understood that center ring 216 can be positioned closer to inner ring 218 or closer to outer ring 214. It will be further understood that although outer ring 214, center ring 216 and inner ring 218 comprise clip openings 210 arranged in a circular fashion around top ring 204 in the exemplary version, other arrangements for clip openings 210 may be used. . For example, the clamp openings 210 may be arranged elliptically or squarely around the top ring 204. In fact, the clamp openings 210 may be arranged in any suitable manner around the top ring 204, as would be evident skilled in the art in view of the teachings of the present invention.
[0061] The staple cartridge 200 fits the tubular housing 22 of the staple head assembly 20. In particular, the lower body 202 provides a friction fit to the tubular housing 22. It will be understood that other suitable ways of connecting the cartridge clamps 200 and the clamping head assembly 20 may be used, as would be apparent to one of skill in the art in view of the teachings of the present invention. For example, the staple cartridge 200 may be secured, snap-fitted, threaded, or otherwise selectively connected to the staple head assembly 20 in any other suitable manner. The lower body 202 of the staple cartridge 200 also defines channels 206 operable to receive complementary features of the staple driver 24. The channels 206 are in communication with the staple apertures 210 so that the complementary features of the staple driver 24 can advance through of the channels 206 to drive the clips 250, 252, 254. The opening 212 is sized to receive a cylindrical knife 36, which is driven through the opening 212 to cut the fabric in the manner described above when the fabric is held between the head assembly. of clipping 20 and the anvil 40.
[0062] Figure 8 shows the large clamp 250, which can be positioned within the clamp openings 210 of the outer ring 214. The large clamp 250 comprises a crown 262 and legs 260 extending from the crown 262. As seen in In the illustrated version, legs 260 erupt outward to define a distance, "A," between them, where "A" is wider than crown 262. Each leg 260 ends in an angled tip 264 that functions to assist leg 260 of large clamp 250 to be pushed through tissue. It will be understood that the width of the legs 260 at the distance "A" corresponds to the size of the clamp openings 210 in the outer ring 214. In some cases, "A" is slightly larger than the width of the clamp openings 210 of the outer ring 214, of so that the large clamp 250 is releasably secured to the clamp openings 210 by a slight interference fit.
[0063] Figure 9 shows the middle clip 252, which can be positioned within the clip openings 210 of the center ring 216. The middle clip 252 comprises a crown 268 and legs 266 extending from the crown 268. As seen in In the illustrated version, legs 266 erupt outward so that they define a distance, "B", from each other, where "B" is wider than crown 268. Legs 266 terminate in an angled tip 270 that functions so as to assist the middle staple 252 to be pushed through the tissue. It will be understood that the width of the legs 266 at the distance "B" corresponds to the size of the clamp openings 210 in the center ring 216. In some cases, "B" is slightly greater than the width of the clamp openings 210 of the center ring 216, of so that the middle clamp 252 is releasably secured to the clamp openings 210 by a slight interference fit.
[0064] Figure 10 shows the small clip 254, which can be positioned within the clip openings 210 of the inner ring 218. The small clip 254 comprises a crown 274 and legs 272 extending from the crown 274. As seen in the version As illustrated, legs 272 erupt outward so that they define a distance, "C", from each other, where "C" is wider than crown 274. Legs 272 terminate in an angled tip 276 which functions to assist the small staple 254 to be pushed through the fabric. It will be understood that the width of the legs 272 at the distance "C" corresponds to the size of the clip openings 210 in the inner ring 218. In some cases, "C" is slightly larger than the width of the clip openings 210 of the inner ring 218, of so that the small clip 254 is releasably secured to the clip openings 210 by a slight interference fit.
[0065] As seen in Figures 8 through 10, the large clamp 250 has a crown 262 which is longer than the crown 268 of the medium clamp 252 and the crown 274 of the small clamp 254, where the crown of the medium clamp 252 is longer than the crown 274 of the small clip 254. It should be understood that the relative widths of the clips (250, 252, 254) are such that the small clips 254 can be disposed within the clip openings 210, so that the small clips 254 have a relatively high staple density around the staple cartridge 200. Consequently, the medium staples 252 and the large staples 250 can be arranged around the staple cartridge so that the medium staples 252 are spaced less densely and the large staples 250 are even less densely spaced. As a result of the progressive reduction in crown lengths 262, 268, 274 described above, the number of clamps 250, 252, 254 in each ring 214, 216, 218 can be equal in number.
[0066] Although legs 260, 266, 272 are shown as bursting outward, it will be understood that legs 260, 266, 272 may be perpendicular to crown 262, 268, 274, sharply angled to crown 262, 268, 274 or oriented at any other suitable angle relative to crown 262, 268, 274 as would be apparent to one of skill in the art in view of the teachings of the present invention. Furthermore, it will be understood that the legs 260, 266, 272 need not necessarily have a straight shape. For example, legs 260, 266, 272 can be curved, slanted, or any other suitable shape that functions to help staples 250, 252, 254 to be guided through fabric. Furthermore, although Figures 8 to 10 show the clamps 250, 252, 254 having legs 260, 266, 272 of generally equal thickness, it will be appreciated that the legs 260, 266, 272 may have different thicknesses. For example, large clamp 250 may have legs 260 thicker or thinner than legs 272, 266 of small clamp 254 or medium clamp 252. In still other versions, instead of having a uniform thickness, legs 260, 266 , 272 may have different thicknesses. For example, legs 260, 266, 272 may be thicker or thinner near crown 262, 268, 274 or tip 264, 270, 276 or any other suitable variation as would be evident to one of skill in the art in view of the teachings of present invention. Although the exemplary version shows the staple cartridge 200 having three rings 214, 216, 218 of staples 250, 252, 254, it will be understood that two rings or more than three rings of staples may be used.
[0067] Figure 11 shows staples 250, 252, 254 placed within staple openings 210 of staple cartridge 200. It will be appreciated that staples 250, 252, 254 may come preloaded, but in other versions it will be understood that staples 250, 252, 254 can be loaded into staple cartridge 200 at any suitable time prior to using the stapling instrument 10.
[0068] In an exemplary use of the staple cartridge 200, the staple cartridge 200 can be loaded as seen in Figure 11. The lower body 202 can be inserted into the tubular housing 22. The tubular element 44 is positioned through the opening 212 of the cartridge. of staples 200. In addition, circular knife 36 is intended to move through opening 212 of staple cartridge 200. Staple driver 24 is positioned relative to staple cartridge 200 so that as staple driver 24 if it travels distally, the clamp driver 24 advances through the channel 206 to drive the clamps 250, 252, 254 distally. As a result, when the driver 74 is rotated, the clip driver 24 acts longitudinally, which drives the clips 250, 252, 254 distally into the tissue. The legs 260, 266, 272 of the staples 250, 252, 254 contact the staple-forming pockets 52 of the anvil head 48, thereby flexing the legs 260, 266, 272 towards their respective crowns 262, 268 , 274. The circular knife 36 also moves to cut the fabric. Circular knife 36 retracts and then staple driver 24 retracts. Clamps 250, 252, 254 remain in tissue where they secure an anastomosis between two body lumens in a patient (eg, securing two ends of an esophagus, colon, or other portion of the GI tract together, etc.). It will be appreciated that when driven into tissue, the clamp ring formed by the outer large clamps 250 can function to structurally secure the anastomosis, while the clamp ring formed by the medium clamps 252 or the small clamps 254 will function. in order to avoid anastomotic leakage. In other words, large clip 250 can primarily serve a structurally reinforcing function, while medium clip 252 and/or small clip 254 can primarily serve a function to provide a fluid-tight seal. Clamps 250, 252, 254 may function to dissolve at a later point in time. III. Exemplary Clamp Support Element
[0069] It will be understood that as the staples 250, 252,254 are driven into the tissue, in some cases, given the thickness of the staples 250, 252, 254, the staples 250, 252, 254 may have a tendency to fail or fail to remain anchored in the fabric. Figure 12 shows an exemplary staple pad or support element 300 that can be used to effectively increase the size of the area occupied by a staple crown, thus reducing the possible risk of the crown otherwise penetrating tissue . The support element 300 of this example comprises a support element body 302 that defines a pair of apertures 304 that function to receive legs 260, 266, 272 of clamps 250, 252, 254. Body 302 further defines an aperture. of body 310 which extends through the body of the staple support element 300. It will be appreciated that the staple support element 300 can be used to prevent the staples 250, 252, 254 from tearing through tissue. In addition, the staple support element 300 can function to reduce leak paths in the area where the staples 250, 252, 254 are inserted into tissue and can further absorb leaks should they occur. The clamp support element 300 is dimensioned such that the clamp support element 300 can be placed in the clamps 250, 252, 254 such that the clamps 250, 252, 254 can still be placed within the clamp openings 210, shown, for example, in Figure 11. Furthermore, it will be appreciated that the clip support element 300 may be sized differently to fit different sizes of clips 250, 252, 254. The clip support element 300 may be constructed to from any suitable material that functions to prevent leakage or to absorb fluid seeping from the tissue around the clip application 250, 252, 254. For example, the clip support member 300 may be constructed of a polymeric material or in addition to it or it may be constructed of an absorptive material. Other materials suitable for a clamp support element 300 may be included, as would be apparent to one of ordinary skill in the art in view of the teachings contained herein.
[0070] Apertures 304 are positioned to align with legs 260, 266, 272 of clamps 250, 252, 254 as shown when adjusted in Figures 13 to 15. Apertures 304 are circular in shape, but will be understood that they can be in any suitable format. For example, openings 304 may be square, elliptical, or any other shape suitable for receiving legs 260, 266, 272. When legs 260, 266, 272 are inserted into openings 304, openings 304 are shaped to be snug. enough or spaced apart so that a friction fit retains the body 302 over the clamps 250, 252, 254. The opening of the body 310 is positioned to approximately align with the crowns 262, 268, 274 of clamps 250, 252, 254 In the exemplary version, the body opening 310 has an enlarged transverse shape. In other versions, it will be understood that the body opening 310 can be of any suitable shape. For example, body opening 310 can be circular, square, or any suitable shape. In some versions, it will be understood that the opening of the body 310 may be omitted.
[0071] Clamp support element 300 additionally includes tabs 306 that extend outwardly from body 302. Although tabs 306 in the exemplary version have a block-like shape, other suitable shapes can be used. By way of example only, tabs 306 may have a rounded or triangular shape. The exemplary version shows tabs 306 on opposite sides of body opening 310, but it will be appreciated that tabs 306 can be positioned in any suitable area around clip support member 300. In addition, tabs 306 can be so constructed. that more than two tabs 306 can be positioned around clamp support member 300. Other suitable variations will be apparent to those skilled in the art in view of the teachings of the present invention.
[0072] The clamp support element 300 further comprises a plurality of ridges 308 positioned close to the openings 304. The ridges 308 are positioned equidistantly around the openings 304, but it will be understood that the ridges 308 may be positioned anyway fit around openings 304. In some versions, ridges 308 can be excluded entirely.
[0073] Figure 13 shows clip support element 300 fitted over large clip 250. Figure 14 shows a medium clip support element 350, which is essentially identical to clip support element 300, but reduced to fit to the medium clamp 252. The medium clamp support element 350 may be fitted over the medium clamp 252 as seen in Figure 14. Figure 15 shows a small clamp support element 352, which is essentially identical to the medium clamp support element. clip 300, but reduced to fit the small clip 254. The small clip support element 352 may be fitted over the small clip 254, as seen in Figure 15. It will be understood that the clip support elements 300, 350, 352 they may also have other sizes not shown in the illustrated version to accommodate larger or smaller clamps. Furthermore, in some versions, only one set of clamps (eg large clamps 250) is equipped with support elements 300, while the other clamps (eg clamps 252, 254) are not. Other variations suitable for providing only a few clips with support elements 300 will be apparent to one skilled in the art in view of the teachings of the present invention.
[0074] Figure 16 shows an exemplary staple cartridge 400 with staples 250, 252, 254 loaded into the staple openings 410 of the staple cartridge 400. It will be appreciated that the staple openings 410 may be the same size as the openings of staples 210 shown in Figure 7, but it will also be understood that staple apertures 410 may be shaped to complement staples 250, 252, 254 equipped with staple support elements 300. In addition, staple cartridge 400 may be configured with another mode and function in essentially the same manner as described above for the staple cartridge 200. It will be understood that the staple support members 300 with the staples 250, 252, 254 may function to provide greater structural integrity of an anastomosis and may It also reduces leakage risks by minimizing the number and size of potential leakage paths in the anastomosis. IV. Clamp support element with exemplifying tabs
[0075] Figure 17 shows an exemplary alternative version of a clamp support member 500 having a body 502, apertures 504 and longitudinally oriented tabs 506. The longitudinally oriented tabs 506 extend outwardly from the body 502 along a longitudinal axis defined by the body 502. The tabs 506 function to increase the projection area of the staple support element 500 to further reduce the possible risk of the staples 250, 252, 254 inadvertently slipping through the fabric. As can be seen in Figure 17, due to the inclusion of tabs 506, the clamp support element 500 has an extended projection area. Tabs 506 can function to provide greater structural integrity of an anastomosis in conjunction with support element 500 and clips 250, 252, 254 and can further reduce leakage risks by minimizing the number and size of potential pathways of leakage in the anastomosis.
[0076] Figure 18 shows an exemplary alternative version of a clamp support element 600 having a body 602, apertures 604 and transversely oriented tabs 606. It will be understood that the transversely oriented tabs 606 may function to provide a projection area enlarged for clip support element 600. Although the exemplary version shows clip support element 600 having four transversely oriented tabs 606, it will be appreciated that any suitable number of tabs 606 can be used. Figure 19 shows an exemplary alternative version of a clamp support member 700 having a body 702, apertures 704 and a combination of transversely oriented tabs 706 and longitudinally oriented tabs 708. Due to transversely oriented tabs 706 and longitudinally oriented tabs 708 , it will be appreciated that the clamp support element 700 has a wider and longer projection area. As discussed above, tabs 606 with support element 600 can function to provide greater structural integrity of an anastomosis in conjunction with clips 250, 252, 254 and can further reduce leakage risks by minimizing number and size of potential anastomotic leakage trajectories.
[0077] Figure 20 shows the staple holder element 700 placed within an opening 710 of a staple cartridge 750. The horizontal tabs 706 and vertical tabs 708 function to fit outside the opening 710 so that the tabs 706 (706, 708) do not fall through the opening 710. The clip support element 700 can be loaded with a clip (not shown) by passing it through the openings 704. staple 700, both staple and support member 700 exit opening 710 of staple cartridge 750 to engage tissue.
[0078] It should be understood that any teachings, expressions, modalities, examples, etc. described herein may be combined with any other teachings, expressions, modalities, examples, etc. which are described here. Therefore, the teachings, expressions, modalities, examples, etc. described above should not be viewed in isolation from one another. Various suitable ways in which the teachings of the present invention may be combined will be readily apparent to those skilled in the art in view of the teachings of the present invention. These modifications and variations are intended to be included within the scope of the appended claims.
[0079] It is understood that any patent, publication or other descriptive material, in whole or in part, which is said to be incorporated into the present invention by way of reference, is incorporated into the present invention only if the incorporated material does not enter into conflict with existing definitions, statements, or other disclosure material presented in this description. Accordingly, and to the extent necessary, the description as explicitly stated herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, incorporated by reference into the present invention but which conflicts with the definitions, statements, or other descriptive materials set forth herein will be incorporated herein only if none appear among the material. incorporated and the existing description material.
[0080] Versions of the devices described above may have application in conventional medical treatments and procedures conducted by a medical professional, as well as application in robotic-assisted medical treatments and procedures. By way of example only, various teachings of the present invention can be readily incorporated into a robotic surgical system, such as the DAVINCI™ system by Intuitive Surgical, Inc., of Sunnyvale, California, USA. Similarly, those skilled in the art will recognize that the various teachings of the present invention can be easily combined with the various teachings of US Patent No. 6,783,524 entitled "Robotic Surgical Tool with Ultrasound Cauterizing and Cutting Instrument", which issued on August 31, 2004, the description of which is incorporated herein by reference.
[0081] The versions described above can be designed to be discarded after a single use or to be used multiple times. Versions can, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning can include any combination of steps of disassembling the device, followed by cleaning or replacing particular parts, and subsequent reassembly. In particular, some versions of the device can be disassembled, and any number of particular parts or parts of the device can be selectively replaced or removed in any combination. With cleaning and/or replacement of particular parts, some versions of the device can be reassembled for subsequent use in a reconditioning facility or by a user immediately prior to a surgical procedure. Those skilled in the art will understand that reconditioning a device can utilize a variety of techniques for disassembly, cleaning/replacement and reassembly. The use of such techniques, and the resulting refurbished device, are all within the scope of this order.
[0082] Just as an example, the versions described here can be sterilized before and/or after a procedure. In a sterilization technique, the device is placed in a closed, sealed container such as a plastic bag or TYVEK. The container and device can then be placed in a radiation field, such as gamma radiation, X-rays or high energy electrons, which can penetrate the container. Radiation can kill bacteria in the device and container. The sterilized device can then be stored in a sterile container for later use. The device may also be sterilized using any other known technique, including, but not limited to, beta or gamma radiation, ethylene oxide, or water vapor.
[0083] Having shown and described various embodiments of the present invention, other adaptations of the methods and systems described in the present invention can be carried out by means of suitable modifications by a person skilled in the art without departing from the scope of the present invention. Several of these possible modifications have been mentioned and others will be evident to those skilled in the art. For example, the examples, modalities, geometry, materials, dimensions, proportions, steps and the like discussed above are illustrative and not necessary. Accordingly, the scope of the present invention is to be considered in accordance with the terms of the following claims and it is understood that it is not limited to the details of structure and operation shown and described in the specification and drawings.
权利要求:
Claims (4)
[0001]
1. Apparatus, comprising: (a) a staple cartridge (750) having a plurality of staple openings (710); (b) a plurality of staples, each staple configured to fit within a respective opening (710) of the staple cartridge (750), the plurality of staples disposed in an annular arrangement around the staple cartridge (750), wherein the plurality of staples are configured to be inserted into tissue, wherein each of the plurality of staples comprises a crown and legs extending from the crown in a first direction, the crown having a length defining a longitudinal direction and a width defining a transverse direction; (c) at least one pad, each pad configured to engage the legs of a respective clamp of the plurality of clamps, wherein the at least one pad is configured to slide along the legs of the respective clamp towards the crown, wherein the at least one pad has a width greater than the crown; and (d) at least one tab (706, 708) in communication with the at least one pad, wherein the at least one tab (706, 708) extends outwardly from the at least one pad, wherein the at least one at least one tab (706, 708) is oriented longitudinally or transversely with respect to at least one pad, characterized in that: at least one pad is configured to fit within a respective clip opening (710), and at least one tab (706, 708) is configured to be positioned outside the clamp opening (710) so that the at least one tab (706, 708) does not fall through the clamp opening (710).
[0002]
2. Apparatus according to claim 1, characterized in that at least one pad comprises at least a first pad and a second pad, wherein the first pad has a larger cross-section than the second pad.
[0003]
3. Apparatus according to claim 1, characterized in that at least one pad defines a pair of openings (704) that are intended to receive the legs of the respective clip.
[0004]
4. Apparatus according to claim 1, characterized in that at least one tab (706, 708) includes a combination of transversely oriented and longitudinally oriented tabs (706, 708).
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同族专利:
公开号 | 公开日
EP2931138A2|2015-10-21|
CN104822330B|2017-08-29|
IN2015DN03986A|2015-10-02|
WO2014089200A3|2014-08-21|
MX2015007179A|2015-10-14|
JP6297585B2|2018-03-20|
RU2015126876A|2017-01-12|
JP2015536737A|2015-12-24|
WO2014089200A2|2014-06-12|
BR112015013158A2|2017-07-11|
EP2931138B1|2019-05-15|
CN104822330A|2015-08-05|
RU2668700C2|2018-10-02|
MX364130B|2019-04-12|
US20140158747A1|2014-06-12|
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法律状态:
2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
2019-12-17| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
2021-06-01| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
2021-08-03| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 04/12/2013, OBSERVADAS AS CONDICOES LEGAIS. |
优先权:
申请号 | 申请日 | 专利标题
US13/706,827|2012-12-06|
US13/706,827|US20140158747A1|2012-12-06|2012-12-06|Surgical stapler with varying staple widths along different circumferences|
PCT/US2013/073100|WO2014089200A2|2012-12-06|2013-12-04|Surgical stapler with varying staple widths along different circumferences|
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