巴西专利BR112014022894B1 FIXING DEVICES TO DISPENSING SURGICAL FASTENERS

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专利摘要:
fixtures for dispensing surgical fasteners into soft media. The present invention relates to a fixation device for dispensing surgical fasteners which includes a lower arm having a proximal end, a distal end and a longitudinal axis extending between the distal and proximal ends, and an upper arm which is so connected. articulated with the lower arm. an actuator is coupled to the upper and lower arms to move the distal ends of the arms relative to one another in order to close the clamping device. a surgical clamp dispenser is attached to the distal end of the lower arm. the dispenser includes a cartridge body having a top surface with the surgical clamp dispenser opening. a block is hingedly connected to the distal end of the upper arm. when the clamping device is closed, a bottom surface of the block applies clamping force on the top surface of the cartridge body to dispense one of the surgical clamps at an angle that is perpendicular to the longitudinal axis.
公开号:BR112014022894B1
申请号:R112014022894-9
申请日:2013-03-14
公开日:2021-08-24
发明作者:Doug Souls；Michael Cardinale；Brian Auer；Simon Cohn；Jens-Peter Straehnz
申请人:Ethicon, Inc；
IPC主号:

专利说明:

CROSS REFERENCE TO RELATED DEPOSIT REQUESTS
[001] This application refers to the patent application assigned to the same applicant, US Serial No., filed on the same date as this application, entitled "DEVICES FOR DISPENSING SURGICAL FASTENERS INTO TISSUE WHILE SIMULTANEOUSLY GENERATING EXTERNAL MARKS THAT MIRROR THE NUMBER AND LOCATION OF THE DISPENSED SURGICAL FASTENERS", (Attorney Reference No.: ETH5640USNP) and its description is incorporated herein by reference to the present invention. BACKGROUND OF THE INVENTION field of invention
[002] The present invention relates to medical devices, and more specifically relates to fixation devices used to dispense surgical fasteners within a soft medium. Description of Related Art
[003] Hernia is a condition in which a small loop of bowel protrudes through a weak site or a defect within a patient's abdominal muscle wall or groin. Hernias can result from a birth defect or can be caused by straining or lifting heavy objects. A hernia can leave the patient with an unpleasant-looking bulge of intestinal tissue that protrudes through the defect and can cause pain, reduced lifting capacities, bowel impaction, or possibly other complications if blood flow is cut off to the bulging tissue.
[004] Surgery may be required to correct a hernia. During a hernia repair procedure, the defect is carefully evaluated and examined through an open incision or endoscopically through a trocar. In either case, careful examination is required because of the delicate network of vessels and nerves that surround the defect area. As such, surgeons must conduct hernia repair procedures with great skill and attention.
[005] Correction of a hernia may involve closing the defect with sutures or fasteners. The hernia repair procedure may also involve placing a surgical prosthetic device such as a mesh patch over the open defect, and attaching the mesh patch to the abdominal wall or inguinal floor with conventional sutures or surgical fasteners. The mesh patch acts as a barrier and prevents the bowels from being expelled through the defect.
[006] A common type of hernia is a ventral hernia. This type of hernia typically occurs in the abdominal wall and can be caused by an anterior puncture or incision, or by an area of tissue weakness that is stressed. There are several correction procedures that can be used by the surgeon, depending on the individual characteristics of the patient and the nature of the hernia. In an onlay-type intraperitoneal mesh correction technique (IPOM), a specific mesh is used with a flat correction layer fused to a fixation layer around the perimeter. The securing layer has an opening to facilitate insertion of an anchoring device between the layers. During an IPOM repair, an incision is made directly over the ventral hernia site. The mesh is laminated and inserted through the incision and hernia into the preperitoneal space. The mesh is then placed centrally below the hernia with the patch layer down, facing the viscera. Fixation sutures can be placed to position the mesh. Then, a fixation device is used to secure the fixation layer to the abdominal wall. Fixing the top fixing layer will also fix the bottom fixing layer. After the mesh is secured and is flat against the abdominal wall, the hernia defect and skin incision can be closed using sutures.
[007] At present, there are a variety of surgical instruments and fasteners used to attach patches of mesh to tissue. One of the earliest types of surgical instruments used is a surgical stapler, whereby a stack of staples is contained within a fixation cartridge, and are sequentially advanced into the instrument by a spring mechanism. A secondary mechanism is employed to separate the most distal staple of the stack from the stack, to retain the remainder of the staples from the stack, and to feed the most distal staple of the stack into the staple forming mechanism. Feeding mechanisms of this type are found in US patents 5,470,010 and 5,582,616 by Rothfuss et al.
[008] Another instrument for securing the hernia mesh uses a helical wire fastener that resembles a small section of a spring. Multiple helical wire fasteners are stored serially within a 5mm shank, and are threaded into the fabric. A load spring is used to feed the plurality of helical fasteners distally into the rod. A protrusion extends into the stem to prevent the stack of fasteners from being ejected by the load spring to allow passage of a swivel fastener. Instruments and fasteners of these types are found in US Patent Nos. 5,582,616 and 5,810,882 to Bolduc et al., and US Patent No. 5,830,221 to Stein et al.
[009] Other surgical fasteners used for hernia mesh fixation utilize a refillable single-shot instrument or a swivel cartridge that retains a small number of fasteners. These types of surgical fixation instruments are disclosed in US Patent Nos. 5,203,864 and 5,290,297 to Edward Phillips. These instruments have not been well accepted by the surgeon community, possibly due to their single-shot capabilities and the large size of the rotating cartridge, which may restrict the use of such an instrument for an open procedure.
[0010] US patents 5,601,573; 5,833,700; and 5,921,997 by Fogelberg et al. teach a cleat applicator with a feed mechanism that uses a reciprocating feed bar to feed a stack of cleats. A feeder shoe operatively engages with and moves with the feed bar in distal movement and slidingly engages with the feed bar in proximal movement. The feeder shoe pushes the clip stack distally with the feed bar moving distally and remains stationary relative to the feed bar moving proximally. A valve mechanism separates the most distal clip from the stack and holds the stack stationary as the most distal clip can be dispensed into a vessel.
U.S. Patent No. 4,325,376 to Klieman et al teaches a clip applier that stores a stack of clips in a serial fashion within a clip cartridge. The most proximal clip is pushed distally by a claw that is ratcheted distally by a reciprocating member with each actuation of the instrument. As the jaw ratchets distally, it pushes the clip stack distally.
The commonly assigned patent application publication U.S. 2002/0068947, the disclosure of which is incorporated herein by reference, teaches a device for releasing a plurality of individual surgical fasteners. In one embodiment, the delivery device includes a drive mechanism that has both distal and proximal ends. The drive mechanism has a moving element and a fixed opposite element, so that the moving element can be moved proximally and distally with respect to the delivery device. The moving element has a sharpened distal end for piercing tissue. The device includes at least one surgical fastener located between the first and second elements. Each of the surgical fasteners has a proximal end and a distal end. The device also has an actuator that has at least two sequential positions. A first position for advancing the moving member distally and piercing the tissue, and a second position for moving the moving member proximally, thus deploying the distal end of the fastener.
[0013] The instruments described thus dispense surgical fasteners along an axis that is parallel to the longitudinal axis of the instrument. In some cases, this angle of application makes it difficult for medical personnel to insert surgical fasteners along axes that are normal {to the surface of the tissue receiving the fasteners. In addition, conventional instruments require the operator to use their hand as a support to provide an opposing force on the fabric receiving the fasteners. This often results in medical personnel being bitten by the sharp edges of surgical fasteners.
[0014] In view of the deficiencies noted above, there is a need for improved systems, devices and methods to more economically and effectively secure prosthetic devices with the use of surgical fasteners. In particular, there is a need for instruments that easily dispense surgical fasteners at angles that are perpendicular to the surface of the tissue receiving the fasteners. There is still a need for instruments that do not require medical personnel to use a second hand as an anvil for tissue receiving the surgical fastener. There is still a need for an instrument that does not require a surgical clamp when sufficient compression has been applied and that provides an indication that a predetermined level of compression has been achieved. There is still a need for a device that provides a clear map of the patient's outer skin surface that indicates the location where the surgical fasteners were inserted, as well as the total number of surgical fasteners that were dispensed into the tissue. SUMMARY OF THE INVENTION
[0015] In one embodiment of the present invention, a fixation device includes a surgical fastener dispenser adapted to dispense surgical fasteners within a soft medium for securing prosthetic devices, such as surgical mesh implants, to the soft medium. Specifically, the modality can be used to secure layered mesh implants during an IPOM correction procedure. The securing device preferably includes a pair of opposing arms that are adapted to be positioned on opposite sides of the target soft medium. A first arm of the arms can be positioned within a surgical opening to oppose an inner surface of the soft middle (eg, the peritoneum of the inner abdominal wall) and the second arm of the arms can be positioned outside the surgical cavity to oppose a outer surface of the soft middle (eg, a patient's outer skin surface).
[0016] In one embodiment, the securing device preferably includes a fixed lower arm that has a pistol grip handle, and a slide trigger coupled to an actuation assembly used to close the distal ends of the upper and lower arms. and to generate a clamping force on opposing surfaces of the target medium. During a fixation operation, the fixation device desirably performs three functions, namely, to secure the soft medium, deliver the surgical fasteners one at a time into the soft medium at an angle that is normal for the soft medium surface to in order to secure a prosthetic device to the soft medium, and prepare the fixation device to dispense another surgical fastener during the next fastener discharge cycle. In one embodiment, the fixation device can deliver surgical fasteners into the soft medium at an angle that is not normal or perpendicular to the surface of the soft medium.
[0017] In one embodiment, the surgical fastener dispenser preferably includes a sterile cartridge body containing a predetermined number of surgical fasteners (e.g. 20), preloaded into the cartridge body to provide the fixation device with multiple discharge capacities. In one embodiment, the cartridge body can be sterilized as a separate component before being loaded onto the lower arm, such as the distal end of the lower arm.
[0018] The fixation device disclosed herein desirably dispenses surgical fasteners in a consistent, controlled and repeatable manner from the distal end of the fixation device. It is preferred that all surgical fasteners are inserted into the soft medium with the same force and at the same angle. In one embodiment, the distal end of the surgical fastener dispenser preferably has a spacer or alignment element that is first positioned against the seam or edge of a mesh patch (e.g., the seam of a layered mesh pocket ) to ensure that the surgical clamp dispensed from the surgical clamp dispenser is delivered to a location that is a fixed distance away from the joint. The spacer enables surgical personnel to repeatedly and reliably deliver surgical fasteners at the fixed distance away from the joint.
[0019] In one embodiment, during initial insertion and positioning of the surgical fastener dispenser within a surgical opening, the spacer at the distal end of the cartridge body preferably hides the surgical fasteners and an insertion fork used to insert surgical fasteners. The surgical fasteners and insertion fork are preferably exposed only after the lower arm and the surgical fastener dispenser are properly inserted and positioned. In one embodiment, the cartridge body is pivotally connected with a surgical clamp dispenser support tray, and the distal end of the cartridge body deflects or pivots downward during compression of the clamp to expose a loaded surgical clamp on the insertion fork.
[0020] In one embodiment, a force limiting system prevents a user from exerting excessive compressive forces and undue stress on the surrounding tissue. In one embodiment, the clamping device preferably includes a preloaded extension spring that connects two ends of one of the clamping arms. In one embodiment, the extension spring is desirably fixed at an angle, thereby creating torque between the two components. The spring allows the clamping device to close until the torque value is reached. At that point, the compression force exceeds the preload level on the extension spring and the spring begins to absorb any remaining compression forces, thereby preventing further displacement of the distal end of the arm while enabling the proximal end of the arm to continue to move.
[0021] In one embodiment, the fixture jaws provide a scalable opening and may include adjustable features that compensate for a range of patient tissue and mesh thicknesses that have different sizes, shapes, and dimensions. Furthermore, the fastening device disclosed in the present invention can be used with laminated flat meshes and layered skirt meshes.
[0022] In one embodiment, the fixation device preferably includes a weight block to a distal end of one of the arms. The block self-adjusts to provide an opposing force to the surgical clamp dispenser. The self-adjusting block also facilitates one-handed use as there is no need to provide back pressure with the user's second hand. In one embodiment, the block is a pivoting block attached to the distal end of one of the arms. In one embodiment, the block is attached to one of the arms using a linear mechanism.
[0023] In one embodiment, the fixture has a slide-grip handle that preferably provides secure control and allows one-handed use. The slide-grip handle also preferably allows the user's hand to be free of obstructions and provides a clear line of sight for inserting the distal end of the device into a cavity. In one embodiment, the clamping device is actuated, preferably transferring linear force to the driver through a rack and pinion system to generate a rotating torque.
[0024] In one embodiment, the fixture may include a pivot-style cable that is offset from the arms for ergonomic one-handed use. The arms pivot preferably around a main pivot point, which results in the delivery of torque to the clamping ends of the arms.
[0025] In one embodiment, the pivot block desirably includes a marker that enables a surgeon to determine and see on the skin where the surgical fasteners have been positioned internally. Since the marker lines up with the dispenser opening when a surgical fastener is dispensed, the marker produces an exact copy or image of the location of the surgical fastener that has been inserted into the abdominal wall. In addition, the marker system also preferably provides an indication of the total number of surgical fasteners that have been dispensed within the abdominal wall.
[0026] In one embodiment, the fixture for dispensing surgical fasteners preferably includes a lower arm having a proximal end, a distal end, and a longitudinal axis extending between the distal and proximal ends, and an arm upper arm pivotally connected with the lower arm and having a distal end that is opposite the distal end of the lower arm. The upper arm is preferably curved and has a concave surface which is opposite the lower arm. The clamping device desirably includes an actuator coupled to the upper and lower arms to move the distal ends of the upper and lower arms towards each other in order to close the clamping device.
[0027] In one embodiment, a surgical fastener dispenser is preferably attached to the distal end of the lower arm for dispensing surgical fasteners. The surgical clamp dispenser desirably includes a cartridge body having a top surface with a surgical clamp dispenser opening formed therein. A plurality of surgical fasteners are desirably preloaded into the cartridge body to be dispensed one at a time through the dispenser opening. The securing device preferably includes a block pivotally connected to the distal end of the upper arm, the block having a bottom surface that is opposite the dispenser opening. In one embodiment, when the fixture is closed, the block pivots to self-adjust so that the bottom surface of the block applies an anchoring force to the top surface of the cartridge body to dispense one of the surgical fasteners from the dispenser opening.
[0028] In one embodiment, the actuator preferably includes a hand grip attached to the lower arm and an actuator mounted on the lower arm and attached to the upper arm. The actuator is adapted to be pulled towards the handgrip to close the clamping device to generate clamping force and dispense a surgical clamp. The actuator is adapted to move away from the hand grip to open the clamping device to release clamping force. In one embodiment, the actuator desirably includes an actuator return spring coupled to the actuator to normally urge the actuator to move away from the handgrip.
[0029] The actuator may also include a rack and pinion system that connects the actuator with the upper arm. In one embodiment, the rack and pinion system desirably includes a rack that has teeth. The rack slides along the longitudinal axis of the lower arm. The proximal end of the upper arm includes a pinion which has teeth that intermingle with the teeth on the rack.
[0030] In one embodiment, the surgical clamp dispenser preferably includes a support tray that has a proximal end connected with the distal end of the lower arm, and a distal end that includes an insertion fork that extends along. of an axis that is perpendicular to the longitudinal axis of the lower arm, whereby the cartridge body overlaps the support tray. In one embodiment, the insertion fork extends along an axis that defines a constant or predetermined angle with respect to the longitudinal axis of the lower arm. In one embodiment, the cartridge body preferably has a proximal end pivotally connected with the proximal end of the support tray, and a distal end freely movable relative to the distal end of the support tray, the top surface of the cartridge body extending between the distal and proximal ends of the cartridge body and the dispenser opening is in alignment with the insertion yoke. The surgical clamp dispenser also preferably includes a cartridge body return spring in contact with the cartridge body and the support tray to normally urge the distal end of the cartridge body away from the support tray, from so that the surgical fasteners are arrayed in a series to be dispensed one at a time from the dispenser opening and so that each of the surgical fasteners has an insertion end oriented towards the top surface of the cartridge body . In one embodiment, the cartridge body return spring preferably engages the cartridge body and the support tray to normally urge the top surface of the cartridge body in a plane that is parallel to the longitudinal axis of the lower arm. In one embodiment, the cartridge body is not hingedly connected to the support tray and the cartridge body is adapted to move up and down in relation to the support tray.
[0031] In one embodiment, the surgical fastener dispenser may include a surgical fastener advance spring in communication with the surgical fasteners to urge the surgical fasteners toward the distal end of the cartridge body. The surgical fastener advance spring is preferably adapted to urge a first surgical fastener to move into engagement with the insertion fork at the distal end of the support tray to be dispensed through the dispenser opening of the cartridge body. The surgical fasteners preferably extend along planes that are parallel to each other and perpendicular to the longitudinal axis of the lower arm. In one embodiment, the insertion fork is desirably adapted to retain and dispense surgical fasteners along an axis that is perpendicular to the longitudinal axis of the lower arm.
[0032] In one embodiment, the cartridge body is preferably pivotable between an extended position in which the top surface of the cartridge body is parallel to the longitudinal axis of the lower arm and a compressed position in which the top surface of the cartridge body is angled with respect to the longitudinal axis of the lower arm. In one embodiment, the cartridge body is under compression by the block when it is in the compressed position. The cartridge body return spring is preferably compressed when the cartridge body is in the compressed position.
[0033] In one embodiment, the first surgical fastener in the series of surgical fasteners and the insertion fork are covered by the cartridge body when the cartridge body is in the extended position. When the cartridge body is in the compressed position, the first surgical fastener and the insertion fork are at least partially exposed through the dispenser opening for inserting the surgical fastener into the soft medium.
[0034] In one embodiment, the cartridge body preferably has a spacer that protrudes from a distal end thereof that extends beyond the distal end of the support tray to space the dispenser opening from a further end. distal part of the surgical clamp dispenser. The spacer facilitates alignment of the surgical clamp dispenser with respect to an edge or seam of a surgical mesh to ensure that they are inserted a proper distance away from the edge or seam.
[0035] In one embodiment, the block on the upper arm desirably includes a marker accessible on the bottom surface thereof that is aligned with the dispenser opening when the fixture is closed. The marker is desirably adapted to produce a visual indicator on a patient's outer skin surface that mirrors the location of one of the surgical fasteners inserted into the patient's inner surface.
[0036] In one embodiment, the block desirably includes a bevel washer adapted to generate an audible snap when the clamping force between the block and the cartridge body reaches a predetermined level. The snap provides an indication that sufficient compressive force has been applied to the soft medium to dispense one of the surgical fasteners within the soft medium.
[0037] In one embodiment, an attachment device for dispensing surgical fasteners preferably includes a lower arm having a proximal end, a distal end and a longitudinal axis extending between the distal and proximal ends, and an upper arm hingedly connected with the lower arm and having a distal end opposite the distal end of the lower arm. The clamping device desirably has an actuator coupled with the upper and lower arms to move the distal ends of the upper and lower arms towards each other to close the clamping device to generate a clamping force therebetween.
[0038] A surgical clamp dispenser can be attached to the distal end of the lower arm. The surgical fastener dispenser desirably has a plurality of surgical fasteners loaded onto it. The surgical clamp dispenser preferably includes a dispenser opening adapted to dispense the surgical clamps one at a time.
[0039] The fixture desirably includes a block pivotally connected to the distal end of the upper arm, the block having a bottom surface opposite the dispenser opening, through which when the fixture is closed, the surface The bottom of the block applies an opposing clamping force on the top surface of the surgical clamp dispenser to dispense one of the surgical clamps along an axis that is perpendicular to the longitudinal axis of the lower arm.
[0040] In one embodiment, the surgical clamp dispenser desirably includes a support tray that has a proximal end connected to the distal end of the lower arm, and a distal end that includes an insertion fork that extends along a axis that is perpendicular to the longitudinal axis of the lower arm. The dispenser preferably includes a cartridge body overlying the support tray, the cartridge body having a proximal end pivotally connected with the proximal end of the support tray, a distal end freely movable with respect to the distal end of the tray. of support, a top surface that extends between the distal and proximal ends of the cartridge body, and the surgical fastener dispenser opening formed in the top surface and that is in alignment with the insertion fork. The surgical clamp dispenser also desirably includes a cartridge body return spring in contact with the cartridge body and the support tray to normally urge the distal end of the cartridge body away from the support tray.
[0041] In one embodiment, a plurality of surgical fasteners may be disposed within the cartridge body, wherein the surgical fasteners are arrayed in a series to be dispensed one at a time from the dispenser opening. Each of the surgical fasteners preferably has an insertion end oriented towards the top surface of the cartridge body. In one embodiment, when the clamping device is closed, the bottom surface of the block applies a clamping force to the top surface of the cartridge body. The cartridge body is pivotable between an extended position in which the top surface of the cartridge body is parallel to the longitudinal axis of the lower arm and a compressed position in which the top surface of the cartridge body is angled with respect to the longitudinal axis of the lower arm.
[0042] These and other preferred embodiments of the present invention will be as described in detail below. BRIEF DESCRIPTION OF THE DRAWINGS
[0043] Figure 1 shows a right side view of a fixation device that includes a lower arm, a surgical clamp dispenser attached to a distal end of the lower arm, and an upper arm opposite the surgical clamp dispenser, in accordance with an embodiment of the present invention.
[0044] Figure 2 shows a cross-sectional view of a left side of the fixture shown in Figure 1.
[0045] Figure 3A shows a left side view of the surgical clamp dispenser shown in Figures 1 and 2.
[0046] Figure 3B shows a cross-sectional view of the surgical clamp dispenser shown in Figure 3A.
[0047] Figure 4A shows a perspective view of a surgical fastener loaded into the surgical fastener dispenser of Figures 3A and 3B, in accordance with an embodiment of the present invention.
[0048] Figure 4B shows a top plan view of the surgical fastener shown in Figure 4A.
[0049] Figure 4C shows a right side elevation view of the surgical clamp shown in Figure 4A.
[0050] Figure 4D shows a left side elevation view of the surgical clamp shown in Figure 4A.
[0051] Figure 5 shows an insertion fork of the surgical clamp dispenser of Figures 3A to 3B aligned with the surgical clamp shown in Figures 4A to 4C.
[0052] Figures 6A to 6C show a method of using the surgical fastener dispenser of Figures 3A and 3B to position a surgical fastener within a soft medium.
[0053] Figure 7 shows a cross-sectional view of a block adapted to be pivotally connected to a distal end of the upper arm of the fixture shown in Figure 1.
[0054] Figure 8 shows the fixation device of Figure 1 in a fixation position for dispensing a surgical clamp to secure a surgical mesh to the soft medium, according to an embodiment of the present invention.
[0055] Figure 9 shows the fastening device of Figure 1 in a fastening position for fastening a mesh with skirt to the soft medium, according to an embodiment of the present invention.
[0056] Figure 10 shows the fixation device of Figure 1 in a position ready for open discharge during a surgical procedure to secure a flat surgical mesh to the soft medium, in accordance with an embodiment of the present invention.
[0057] Figures 11A to 11C show a block having a marker, the block being pivotally connectable to a distal end of the upper arm of the fixture shown in Figure 1, in accordance with an embodiment of the present invention.
[0058] Figures 12A to 12C show a block having a marker, the block being pivotally connectable to a distal end of the upper arm of the fixture shown in Figure 1, in accordance with another embodiment of the present invention.
[0059] Figure 13 shows a fixation device for dispensing surgical fasteners that includes a lower arm and an upper arm, according to another embodiment of the present invention.
[0060] Figure 14A shows the fixation device of Figure 13 with a surgical clamp dispenser attached to a distal end of the lower arm and a force-limiting mechanism installed on the lower cable that is engaged with the upper arm, according to a modality of the present invention.
[0061] Figure 14B shows the fixture of Figure 14A in a closed position for dispensing a surgical fastener within a soft medium, according to an embodiment of the present invention.
[0062] Figure 15 shows a schematic view of a fixture that includes a lower arm and an upper arm joined by a scissors jack mechanism and having in-line cables, according to an embodiment of the present invention.
[0063] Figure 16 shows a schematic view of a fixture that includes a lower arm and an upper arm joined by a scissors jack mechanism and having deflection cables, according to an embodiment of the present invention.
[0064] Figure 17 shows a schematic view of a fastening device that includes a lower arm and an upper arm joined by a parallel connecting mechanism, according to an embodiment of the present invention.
[0065] Figure 18 shows a schematic view of a fastening device that includes a lower arm and an upper arm joined by a rack and pinion gear mechanism, according to an embodiment of the present invention. DETAILED DESCRIPTION
[0066] Referring to Figure 1, in one embodiment, a fixture 20 for dispensing surgical fasteners within soft media preferably includes a lower arm 22 having a proximal end 24 and a distal end 26, and a surgical clamp dispenser 28 secured to the distal end 26 of the lower arm 22. The surgical clamp dispenser has a distal end 30 which is adapted to dispense a single surgical clamp during each clamp discharge cycle, as will be described in more detail in present invention. Lower arm 22 desirably extends along a longitudinal axis A1-A1. The securing device 20 preferably includes a handle 32 provided at the proximal end 24 of the lower arm 22 and a driver 34 which is adapted to slide relative to the lower arm, preferably along the longitudinal axis A1-A1, to operate. the fixing device. The handle 32 preferably has a forward tilt angle towards the distal end 26 of the lower arm 22, which ensures that the user's wrist and hand can be in a more favorable ergonomic position during operation of the fixation device. 20.
[0067] In one embodiment, the securing device 20 preferably includes an upper arm 36 having the proximal end 38 and the distal end 40. The proximal end 38 of the upper arm 36 is pivotally secured to the lower arm 22 , preferably by means of a rack and pinion system. In one embodiment, the upper arm 36 defines an arc or curve. The fixture 20 desirably includes a block 42 pivotally connected to the distal end 40 of the upper arm 36. The block 42 preferably pivots so that the block can self-adjust to oppose the top surface of the dispenser. surgical fastener 28 when the distal end 40 of the upper arm 36 is pivoted toward the cartridge assembly 28 to be moved to a closed lock position.
[0068] Referring to Figure 2, in one embodiment, the lower arm 22 preferably includes the handle 32 and the slideable actuator 34 coupled thereto. Slide actuator 34 desirably includes a lower end 50 that is secured to a rack 52 of a rack and pinion system by means of a fastener 54. Rack 52 preferably includes rack teeth 56 that engage the teeth of pinion 58 on a pinion 60, which is preferably secured to the proximal end 38 of the upper arm 36. The securing device 20 desirably includes an actuator return spring 62 extending between a proximal end of the rack 52 and a spring tensioner 64 insertable into an opening in a proximal end 24 of the lower arm 22.
[0069] In operation, as the actuator 34 is pulled towards the proximal end 24 of the lower arm 22, the actuator 34 and rack 52 move along the axis A1-A1 towards the proximal end 24 of the lower arm 22 Rack 52 rotates pinion 60 in a counterclockwise direction, which swings distal end 40 of upper arm 36 and block 42 toward distal end 30 of surgical clamp dispenser 28. Conform to distal end 40 of arm The upper 36 moves toward the cartridge assembly 28, the block 42 preferably moves in alignment opposite the distal end 30 of the surgical clamp dispenser 28. As the driver 34 moves toward the handle 32, the spring Actuator return 62 is preferably compressed between the rack 52 and the spring tensioner 64. When the actuator 34 is released, the energy stored in the actuator return spring 62 urges the actuator 34 to slide along the axis A1- A1 towards connection to the distal end 26 of the lower arm 22.
[0070] Referring to Figures 3A and 3B, in one embodiment, the surgical clamp dispenser 28 preferably includes a clamping arm 66 which is attachable to the distal end 26 of the lower arm 22 of the clamping device 20 (Figure 2). The surgical clamp dispenser 28 desirably has a support tray 68 that projects distally from the fixation arm 66. The support tray 68 preferably has a proximal end 70 adjacent to the fixation arm 66, an end distal end 72 spaced apart from the proximal end 70, and an insertion fork 74 projecting upwards from the distal end 72 of the support tray 68. In one embodiment, the clamping arm 66 and the support tray 68 extend, from preferably, along the longitudinal axis A1-A1 of the lower arm 22 (Figure 2), and the fork 74 preferably extends along a vertical axis Y1-Y1 that is perpendicular to the axis A1-A1. As will be described in more detail in the present invention, the insertion fork 74 is adapted to engage a surgical fastener for inserting the surgical fastener into a soft medium such as tissue.
[0071] In one embodiment, the surgical fastener dispenser 28 desirably includes a cartridge body 76 having a plurality of surgical fasteners 78 loaded therein. Cartridge body 76 preferably has a proximal end 80 that is pivotally secured to the proximal end 70 of the support tray 68 by means of pivot pin 81, and a distal end 82 that is free to pivot toward and in the opposite direction from the distal end 72 of the support tray 68. The cartridge body 76 preferably has a dispenser opening 84 adjacent the distal end 82 thereof through which the fork 74 and surgical fasteners 78 can pass. In one embodiment, as the distal end 82 of the cartridge body 76 moves downwardly toward the distal end 72 of the support tray 68, the insertion fork 74 and a first surgical fastener loaded into the insertion fork pass through the opening of dispenser 84 in cartridge body 76. Distal end 82 of cartridge body 78 desirably includes a spacer 86 that projects a distance D1 beyond distal end 72 of support tray 68. As will be described in more detail in the present invention , the spacer 86 preferably ensures that the dispenser opening 84 in the cartridge body 78 is positioned within a junction or peripheral edge of a prosthetic device, such as the junction or peripheral edge of a surgical mesh, so that a fastener surgical procedure is not secured over the joint or edge of the prosthetic device.
[0072] In open IPOM procedures, the placement of surgical fasteners or tacks used for fixation is absolutely critical. Surgical fasteners must be placed the correct distance from the mesh edge. If an excessive gap (>5 mm) occurs, the risk of tissue entrapment between the abdominal wall and the prosthetic mesh will increase. This can have an impact on inner growth behavior and possibly lead to serious complications. In open IPOM procedures, it is difficult to control the correct placement of surgical fasteners as visual control is much more difficult compared to laparoscopic procedures in which surgical personnel have a clear view and control of the medical devices. The present invention provides a fixation device that overcomes the deficiencies found in prior art devices.
[0073] In one embodiment, the surgical fastener dispenser 28 preferably includes a cartridge body return spring 88 that extends between the support tray 68 and the cartridge body 76 to normally urge the cartridge body 76 to move to the initial extended position shown in Figures 3A and 3B. When a downward force (generally along the Y1-Y1 axis) is applied to the top surface 83 of the cartridge body 76, the cartridge return spring 88 is compressed between the cartridge body 76 and the support tray 68. When the force is removed, cartridge return spring 88 urges cartridge body 76 to revolve back to the starting position shown in Figures 3A and 3B, whereby the top surface 83 of the cartridge body is parallel to axis A1- TO 1.
[0074] In one embodiment, the surgical fastener dispenser 28 preferably includes a surgical fastener advance 90 that is adapted to urge the surgical fasteners 78 toward the distal end 82 of the cartridge body 76 to be engaged by the fork of insert 74. The surgical fastener dispenser 30 desirably also includes a surgical fastener advance spring 92 which extends between the advancer 90 and a spring lock 94.
[0075] In one embodiment, surgical fasteners 78 are loaded in series in the cartridge body 76 of the surgical fastener dispenser 28. The surgical fastener reload spring 92 desirably urges the series of surgical fasteners 78 toward the distal end 82 of the cartridge body 28. After the insertion fork 74 has dispensed a first surgical fastener into the soft medium, the next surgical fastener is distally advanced towards the distal end 82 of the cartridge body 76 to be aligned with the insertion fork. 74 so that another fixation and dispensing cycle can begin. The dispensing process may be repeated until all surgical fasteners 78 in cartridge body 76 have been dispensed from surgical fastener dispenser 28. A single fastener is dispensed each time the device is stapled to the soft medium.
[0076] Referring to Figures 4A to 4D, in one embodiment, the claw device preferably dispenses surgical fasteners 78 adapted for insertion into a soft medium such as tissue. Surgical fasteners 78 are preferably designed to secure the surgical mesh to tissue. The surgical fasteners and the fixation device for inserting the surgical fasteners may incorporate one or more of the features disclosed in Patent Application No. US 12/464,143, filed May 12, 2009, Patent Application No. US 12/ 464,151, filed May 12, 2009, Patent Application No. US 12/464,165, filed May 12, 2009, and Patent Application No. US 12/464,177, filed May 12, 2009, which of which descriptions are incorporated herein by reference to the present invention.
[0077] In one embodiment, surgical fastener 78 desirably includes a distal end 100 and a proximal end 102, a first leg 104 having a first tip 106 provided at a distal end of the first leg, and a second leg 108 that it has a second tip 110 provided at a distal end of the second leg. In one embodiment, the cross-sectional dimensions of the first and second legs 104, 108 decrease as they move from the proximal ends to the distal ends of the legs. Surgical clamp 78 preferably includes a bridge 112 adjacent to the proximal end 102 of the surgical clamp that connects the proximal ends of the first and second legs 104, 108. In one embodiment, the bridge may be positioned anywhere between the ends. proximal and distal of the surgical clamp as long as it interconnects the first and second legs. Surgical fastener 78 preferably includes at least one first barb 114 projecting rearwardly from the first tip 106 and at least one second barb 116 projecting rearwardly from the second tip 110. Although only one barb is shown on each leg, other surgical fasteners may have multiple barbs on each leg or tip. In one embodiment, the first and second prongs 106, 110 may have a conical shape. The tips can be formed with sharp driving tips or they can be more obtuse.
[0078] In one embodiment, the first and second tips 106, 110 have distal piercing tips that are slanted relative to the longitudinal axes of the respective first and second legs 104, 108. In one embodiment, the distal piercing tips are slanted outward from the longitudinal axes of the first and second legs. The distance between the tips is preferably greater than the distance between the legs to increase the probability of capturing the fibers of a prosthetic device being the legs. In one embodiment, the first and second tips 106, 110 have blunt distal piercing tips, which enable the surgical fastener to penetrate tissue while minimizing unwanted penetration into an operator's hand.
[0079] Referring to Figure 4B, in one embodiment, the bridge 112 preferably includes a concave inner surface 118 facing the distal end 100 of the surgical clamp 78 and a convex outer surface 120 facing the proximal end 102 of the clamp surgical. The first leg 104 has an outer wall that has a first rib 122 that extends along a longitudinal axis A2-A2 of the first leg, and the second leg 108 includes an outer wall that has a second rib 124 that extends along. of the longitudinal axis A3-A3 of the second leg 108. In one embodiment, the distance D2 between the piercing tips at the distal ends of the first and second tips 106, 110 is preferably greater than the distance D3 between the inner surfaces opposing first and second legs 104, 108. The wider relative distance between the distal piercing tips of the first and second tips 106, 110 preferably ensures that the surgical fastener 78 will engage the filaments on a porous prosthetic device, like the surgical mesh filaments used to perform the hernia procedure. In one embodiment, the outwardly angled distal piercing tips provide increased ability to capture surgical mesh fibers when the mesh fibers are separated from one another without the need to increase the gap between each leg.
[0080] Referring to Figure 4C, in one embodiment, the first leg 104 has the first rib 122 that extends along the longitudinal axis A2 of the first leg. When viewed from the side, as shown in Figure 4C, the first rib 122 is preferably in substantial alignment with a distal point of the first piercing tip 106. Referring to Figure 4D, in one embodiment, the second leg 108 it has a second rib 124 that extends along the longitudinal axis A3 of the second leg 108. When viewed from the side, as shown in Figure 4D, the second rib 124 is preferably aligned with a distal point of the second prong 110. .
[0081] Referring to Figure 5, in one embodiment, the surgical fastener 78 is preferably advanced into alignment with the insertion fork 76 located at the distal end 72 of the support tray 68 (Figures 3A and 3B). In one embodiment, insertion fork 76 preferably includes an upper end 130 adapted to engage one or more surfaces of surgical fastener 78 to guide insertion of the surgical fastener within the soft medium. In one embodiment, the upper end 130 of insertion yoke 76 includes a first tooth 132 having a first inner lip 134 formed therein, and a second tooth 136 having a second inner lip 138 formed therein. In one embodiment, the inner edges 134, 138 preferably oppose each other and extend along the Y1-Y1 axis which is perpendicular to the longitudinal axis A1-A1 of the lower arm 22 of the fixture 20 (Figures 1 and two). In operation, the opposing inner lips 134, 138 of the first and second teeth 132, 136 are preferably adapted to engage the ribs on the respective first and second legs 104, 108 of the surgical fastener 78. The engagement of the inner lips 134, 138 with the ribs preferably aligns the surgical fastener 86 to the distal end 130 of the fork 76 and stabilizes the surgical fastener during implantation into tissue. The surgical fastener 78 is brought into contact with the inner lips 134, 138 by the surgical fastener advance spring 92. The surgical fasteners 78 are carried along the axis A1-A1 until they contact the lips 134, 138. 90° angle between insertion fork and axis A1-A1 ensures that surgical fasteners are inserted into the soft medium at an angle that is normal for the surface of the soft medium. In one embodiment, the most distal ends of the first and second teeth 132, 136 are advanced until they abut convex seating surfaces provided near the distal ends of the first and second legs 104, 108.
[0082] Although the present invention is not limited by any particular theory of operation, it is believed that providing an insertion fork 76 with grooved teeth that engage ribs on the outer surfaces of the legs of the surgical fastener 78 will enhance fastener stability and control. surgical clamp when dispensing the surgical clamp from the surgical clamp dispenser 28 (Figures 3A and 3B) of the fixture. Furthermore, at least a portion of the insertion force is provided closer to the distal ends of the legs 104, 108 of the surgical clamp 78 and not just the proximal end of the surgical clamp as is the case with prior art clamps. Providing insertion force over the surgical fastener near the distal end of the clasp can enable smaller and/or lower profile surgical fasteners to be used because, among others, the surgical fastener can be inserted using less force.
[0083] Referring to Figures 6A to 6C, in one embodiment, the surgical fastener dispenser 28 is adapted to deliver surgical fasteners 78 within a soft medium such as tissue. Referring to Figure 6A, cartridge return spring 88 normally urges cartridge body 76 to an initial undeflected position whereby top surface 83 of cartridge body 76 is parallel to the longitudinal axis A1-A1 of the lower arm. 22 (Figure 1). In the initial non-deflected position, none of the surgical fasteners 78 are exposed outside of the cartridge body 76. In addition, the spacer 86 at the distal end 82 of the cartridge body 76 covers the first surgical fastener 78A mounted on the insertion yoke 74. cartridge 76 is in the home position, spacer 86 has a driving surface that is preferably spaced a distance D1 from insertion fork 74, which ensures that surgical fasteners 78, when dispensed, are spaced inwardly. a junction or peripheral edge of a prosthetic device, such as a surgical mesh used to correct a hernia.
[0084] Referring to Figure 6B, in one embodiment, when the fixture is closed, a downward force F1 is exerted on the top surface 83 of the cartridge body 76, when then the distal end 82 of the cartridge body 76 pivots about pivot pin 81 to move the cartridge body to a deflected position. In the deflected position, the top surface 83 of the cartridge body 76 defines an angle with the longitudinal axis A1-A1. As distal end 82 of cartridge body 76 pivots toward distal end 72 of support tray 68, first surgical fastener 78A and top of insertion fork 74 passes through dispenser opening 84 in cartridge body 76 and stops. the soft medium. The fork 74 preferably stabilizes the exposed surgical fastener 78A to control the angle and orientation of the surgical fastener as it is inserted into the soft medium. As cartridge body 76 pivots, cartridge return spring 88 is compressed to store energy therein. In one embodiment, at the end of a fastener discharge cycle, when the downward force F1 is removed, the cartridge return spring 88 returns the cartridge body to the initial undeflected position shown in Figure 6A, whereupon the surface of top 83 of cartridge body 76 is parallel to axis A1-A1.
[0085] Referring to Figure 6C, after the first surgical fastener has been dispensed from the fork 74, the fixture 20 (Figure 1) opens to remove the downward force F1 on the cartridge body 76. When the force descending is removed, cartridge return spring 88 releases the energy stored therein to return cartridge body 76 to the initial undeflected position shown in Figure 6A. As cartridge body 76 returns to the undeflected position shown in Figure 6A, reload spring 92 urges advancer 90 to move toward distal end 82 of cartridge body 76 to advance second surgical fastener 78B into engagement with the insertion fork 74. As the second surgical fastener 78B is loaded onto the insertion fork 74, the cartridge body 76 returns to the initial undeflected position shown in Figure 6A. At this stage, the fixation device is ready for another fastener discharge and fixation cycle to insert the second surgical fastener 78B into tissue.
[0086] Referring to Figures 1 and 7, in one embodiment, the block 42 is pivotally connected to the distal end 40 of the upper arm 36 of the fixture 20 by means of a retaining flange 150 having an opening 152 adapted to receive a pivot pin (not shown). Block 42 desirably includes a bottom surface 154 adapted to oppose the surgical clamp dispenser 28 and a top surface 156 that faces away from the bottom surface. Block 42 preferably includes an internal cavity 158 adapted to receive a bevel washer 160 that provides tactile feedback (e.g., a snap) when sufficient compressive force has been applied by the fixture 20 to properly apply a surgical fastener. In one embodiment, the bevel washer 160 desirably makes a click when compressed, which provides an audible signal to surgical personnel that sufficient compressive force has been applied by the fixation device to properly apply a surgical fastener to tissue. Block 42 may include an opening 162 formed in top surface 156 thereof to enable the click generated by washer 160 to pass therethrough.
[0087] Referring to Figure 8, in one embodiment, the fixation device 20 can be used to secure a prosthetic device, such as a surgical mesh implant 160, to the abdominal tissue 162. In one embodiment, a surgical opening 164 is formed in soft medium 162 to access a patient's inner body region. The surgical mesh 161 is positioned against an inner surface of the abdominal tissue 162. The fixation device 20 can then be used to dispense surgical fasteners 78 from the surgical fastener dispenser 28 secured to the distal end of the lower arm 22. The fasteners Surgical ties 78 are used to secure the surgical mesh 160 to the soft medium 162.
[0088] In one embodiment, the lower arm 22 carrying the surgical clamp dispenser 28 is inserted through the surgical opening 164 and into the patient. The upper arm 36 of the fixation device remains outside the patient with the block 42 opposite the distal end 30 of the surgical clamp dispenser 28. The driver 34 can be pulled towards the hand grip 32 to slide the rack 52 towards the proximal end. 24 of the lower arm 22. As rack 52 moves proximally, rack teeth 56 engage pinion teeth 58 to rotate pinion 60 in a counterclockwise direction, which in turn rotates the distal end. 40 of the upper arm 36 toward the distal end 30 of the surgical clamp dispenser 28. As the actuator 34 is pulled, the bottom surface 154 of the block 42 pivots and self-adjusts to engage the outer surface of the soft means 162. The pivotal connection of block 42 with distal end 40 of upper arm 36 ensures that bottom surface 154 of block 42 remains substantially perpendicular to the vertical orientation of insertion fork 74 and fastener. surgical device 78. The actuator 34 is pulled until sufficient downward force is applied to the cartridge body 76 to deflect the cartridge body toward the support tray 68 so that the first surgical fastener 78 can be inserted by the insertion fork. 74 through surgical mesh 161 and into soft means 162. Bevel washer 160 within block 42 preferably provides an audible click when sufficient compressive force has been applied across the distal ends of lower arm 22 and upper arm 36 .
[0089] After the first surgical clamp 78 on the surgical clamp dispenser has been dispensed, the trigger 34 can be released. Energy stored in actuator return spring 62 slides rack 52 toward the distal end of lower arm 22, which pivots distal end 40 of upper arm 36 away from distal end 30 of cartridge assembly 28. cartridge 76 is then free to pivot away from support tray 68 so that the next surgical fastener 78 can be advanced into engagement with insertion fork 74. The cycle described above can be repeated to dispense additional surgical fasteners from the surgical fastener dispenser 28 of the fixture 20.
[0090] Referring to Figure 9, in one embodiment, the fixation device 20 can be used to secure a surgical mesh with skirt 161' to the soft medium 162'. In Figure 9, the lower arm 22 and the surgical clamp dispenser 28 are passed through a surgical opening 164'. Spacer 86 at the distal end of surgical fastener dispenser 28 is advanced through layers of surgical mesh with skirt 161' until spacer 86 abuts the outer peripheral junction of mesh 161'. Spacer 86 ensures that opening 84 at distal end 82 of surgical clamp dispenser 28 is positioned within outer perimeter 166' of surgical mesh 161'. The actuator of the clamping device 20 can be pulled to pivot the distal end 40 of the upper arm 36 towards the distal end 82 of the surgical clamp dispenser 28. The upper and lower arms 36, 22 are closed towards each other until sufficient clamping force is applied across the distal ends of the respective arms to compress the cartridge body into the surgical clamp dispenser to dispense a surgical clamp. An audible click may be produced by a chamfered washer located within the pivot block 42 to indicate that sufficient compressive force has been applied by the fixture.
[0091] The dispensing cycle described above is repeated until the surgical fasteners are dispensed around the entire outer perimeter 166' of the surgical mesh 161'. In one embodiment, the surgical fasteners are spaced no more than two centimeters apart to ensure that no gap develops between the surgical mesh 161' and the soft medium 162'.
[0092] Referring to Figure 10, in one embodiment, the fixation device 20 is worn over a surgical mesh 161'' that has a folded edge 168''. The cartridge assembly is preferably advanced between surgical mesh 161'' and folded edge 168'' until spacer 86 abuts outer peripheral edge 166'' of surgical mesh 161''. The fixation device 20 can be closed so that the distal end 40 of the upper arm 36 pivots towards the surgical clamp dispenser 28 attached to the distal end of the lower arm 22. Compressive forces are applied through the distal ends of the respective arms. lower and upper 22, 36 until a surgical fastener is dispensed from the surgical fastener dispenser 28. Surgical personnel can discern when sufficient compressive forces have been applied to dispense a surgical fastener when an audible click is produced by an disposed bevel washer inside the pivotally connected block 42. The process described above is preferably repeated around the outer periphery 166'' of the surgical mesh 161'' to dispense a plurality of fasteners around the outer periphery of the mesh.
[0093] Referring to Figures 11A to 11C, in one embodiment, a block 142 is adapted to be pivotally connected to the distal end 40 of the upper arm 36 of the fixture 20 shown in Figures 1 and 2. The block 142 desirably includes a pair of flanges 150A, 150B having aligned openings 152A, 152B therethrough which are adapted to receive a pivot pin for pivotally connecting block 142 to distal end 40 of upper arm 36 ( Figure 1).
[0094] Referring to Figure 11B, block 142 preferably includes a bottom surface 154 adapted to abut an outer surface of the soft medium, such as the outer skin surface of the patient. Referring to Figure 11C, in one embodiment, block 142 preferably includes an inner portion 180 secured to flange 150A, 150B. Inner portion 180 includes a marker 182 provided on a lower end thereof. Marker 182 may be an ink marker adapted to form an ink mark on the surface of the patient's skin. Block 142 preferably includes a lower portion 184 that extends around the upper portion 180. The lower portion 184 includes the bottom surface 154 of the block 142. The bottom surface 154 preferably includes an aperture 185 formed. on it, which enables marker 182 to pass through it. When compressive forces are applied to the bottom surface 154 of the lower member 184, the bottom surface 154 of the lower member 184 preferably slides toward the top surface 156 of the upper member 180 so that the marker 182 projects through the opening 185 in the bottom surface 154 for marking a surface. Block 142 preferably includes a lock 186 and prevents further sliding movement of bottom surface 154 toward top surface 156.
[0095] When a surgical fastener is applied using the fixture disclosed in the present invention, the bottom surface 154 of block 142 desirably opposes the distal end of the cartridge body from which the surgical fastener is dispensed. Marker 182 is preferably aligned with opening 84 provided at distal end 82 of cartridge body 76. Marker areas provided on the patient's skin surface by marker 182 provide an exact mirror image of the location where the surgical clamp was inserted into the soft medium. Therefore, surgical personnel are provided with a precise methodology for tracking how many surgical fasteners were dispensed and the exact location of each surgical fastener.
[0096] Figures 12A to 12C show another block 242 that has a marker 282 that can be used to mark a patient's skin surface to indicate the location where a surgical fastener has been inserted into the patient's tissue. Referring to Figures 12A and 12B, block 242 preferably includes a pair of retaining flanges 250A, 250B which have aligned openings 252A, 252B, respectively, which are adapted to receive a pivot pin for securing block 242 to a distal end of the upper arm of the fixture shown in Figures 1 and 2. Block 242 preferably includes a tube 255 that is adapted to receive a marker 282.
[0097] Figure 12C shows marker 282 inserted into tube 255 of block 242. Block 242 has a bottom surface 254, a top surface 256 and an opening 285 that extends between the bottom and top surfaces 254 , 256. The lower end of marker 282 preferably extends into opening 285 to mark a patient's skin surface when block 242 is pressed against the patient's skin surface. As noted above, marker 282 provides an effective and highly accurate methodology for identifying the location where a surgical fastener has been inserted into a patient's tissue, and for indicating the total number of surgical fasteners inserted into the patient's tissue.
[0098] Referring to Figure 13, in one embodiment, a fixture 320 for dispensing surgical fasteners preferably includes a lower arm 322 extending along a longitudinal axis A4-A4 and a surgical fastener dispenser 328 secured to the distal end of the lower arm 322. The surgical fastener dispenser 328 includes a support tray 368 that has a distal end 372 that includes a fork 374 adapted to insert surgical fasteners into soft media. Insertion fork 374 preferably extends along an axis Y1-Y1 that is substantially perpendicular to the longitudinal axis A4-A4 of lower arm 322 and support tray 368. Lower arm 322 is preferably coupled to a hand grip. 332.
[0099] The fixture 320 preferably includes an upper arm 336 that is pivotally connected to the lower arm 322. The upper arm 336 has a proximal end 338 pivotally coupled to the lower arm 322 and a distal end 340 remote from it. A block 342 is pivotally connected to the distal end 340 of the upper arm 336. The upper arm 336 is desirably connected to a driver 334.
[00100] In operation, the actuator 334 can be pulled toward the handle 332 to move the distal end 340 of the upper arm 336 toward the distal end 372 of the support tray 368. The actuator 334 preferably includes a spring for internal extension 362 which is installed under a load which is applied by means of a cable system through the arms until sufficient compression of the arms is obtained. At that point, further pulling the actuator 334 toward the handle 332 will not result in the exertion of compressive forces through the distal ends of the upper and lower arms. Instead, internal extension spring 362 continues to extend.
[00101] Referring to Figure 14A, in one embodiment, surgical fastener dispenser 328 preferably includes a cartridge body 376 that is pivotally coupled to support tray 368. Cartridge body 376 preferably has a spacer 386 at a distal end thereof, which projects beyond distal end 372 of support tray 368. Cartridge body 376 preferably has a plurality of surgical fasteners (not shown) loaded thereon. During a fastener discharge cycle, when the driver 334 is pulled toward the hand grip 332, compressive forces are applied between the block 342 and the surgical fastener dispenser 328 until one of the surgical fasteners is dispensed from a dispenser opening at distal end 382 of cartridge body 376.
[00102] Figure 14B shows the fixture 320 in a closed position with the block hingedly connected 342 opposite the dispenser opening 384 at the distal end 382 of the cartridge body 376. As the soft medium is compressed between the block 342 and cartridge body 376, distal end 382 of cartridge body 376 pivots in a downward direction toward support tray 368 until the insertion fork at the distal end of support tray 368 pushes a first surgical fastener through the opening. of dispenser 384 for insertion into soft medium.
[00103] Other embodiments of the present invention may include connections that vary from the mechanism shown in Figures 1 and 2 of the present application. In these alternative embodiments, the cable elements pivot relative to one another while the upper and lower arms move towards and away from each other in a parallel or linear fashion. Figures 15 to 18 are schematic drawings that only show the connections that couple the upper and lower arms and the pivoting cables. Although not shown, it is contemplated that the embodiments shown in Figures 15 to 18 may include one or more of the features shown and described above for Figures 1 to 10.
[00104] Referring to Figure 15, in one embodiment, a fixture 420 for dispensing surgical fasteners within soft media preferably includes a lower arm 422 and an upper arm 436 that are joined with a jack connector scissors 455. Clamping device 420 has first and second cables 432, 434 that are in line with respective lower and upper arms 422, 436. As first and second cables 432, 434 pivot toward each other to closing the clamping device 420, the scissor jack connection moves the lower and upper arms 422, 436 towards each other in a parallel or linear fashion to dispense a first surgical clamp (for example, see Figure 6B).
[00105] Referring to Figure 16, in one embodiment, a fixture 520 for dispensing surgical fasteners within soft media preferably includes a lower arm 522 and an upper arm 536 that are joined with a jack connector scissors 555. The clamping device 520 has first and second handles 532, 534 that are offset from the lower and upper arms 522, 536, respectively. As the first and second cables 532, 534 pivot toward each other to close the fixture 520, the scissor jack linkage moves the lower and upper arms 522, 536 toward each other in a linear fashion (i.e. , parallel) to dispense a first surgical clamp (for example, see Figure 6B).
[00106] Referring to Figure 17, in one embodiment, a fixture 620 for dispensing surgical fasteners within soft media preferably includes a lower arm 622 and an upper arm 636 that are joined with a connecting arrangement parallel 655. The fixture 620 has first and second cables 632, 634 that are adapted to pivot relative to one another. As the first and second cables 632, 634 pivot towards each other to close the fixture 620, the parallel connecting arrangement 655t moves the lower and upper arms 622, 636 towards each other in a parallel or parallel fashion. dispense a first surgical clamp (for example, see Figure 6B).
[00107] Referring to Figure 18, in one embodiment, a fixture 720 for dispensing surgical fasteners within soft media preferably includes a lower arm 722 and an upper arm 736 that are joined with a gear mechanism of rack and pinion 755. The fixture 720 has first and second cables 732, 734 that are adapted to pivot relative to one another. As the first and second cables 732, 734 pivot toward each other to close the fastener 720, the rack and pinion gear mechanism 755 moves the lower and upper arms 722, 736 toward each other in a manner. parallel or to dispense a first surgical clamp (for example, see Figure 6B).
[00108] The connections shown and described in the present invention are not the only types of mechanisms that can be used to provide linear movement between the upper and lower arms of the fixture. Other embodiments may have a jack-scissor mechanism with a plurality of connections similar to an accordion-shaped system. In one embodiment, a worm gear mechanism can be employed. In these embodiments, the cable elements desirably pivot towards one another and one against the other as the upper and lower arms move in a linear/parallel fashion.
[00109] In one embodiment, the slide guides can be used to move an upper arm and an upper cable connected thereto towards a lower arm and a lower cable connected thereto, while maintaining linear/parallel movement between the arms Superior and inferior. In this mode, the upper arm/upper cable component moves in a linear/parallel fashion with respect to the lower arm/lower cable.
[00110] Although the foregoing is directed to embodiments of the present invention, other additional embodiments of the invention can be invented without deviating from the basic scope of the same, which is limited only by the scope of the following claims. For example, the present invention contemplates that any of the features shown in any of the embodiments described herein, or incorporated herein by reference, may be incorporated with any of the features shown in any other of the embodiments described herein, or incorporated herein by reference, and still fall within the scope of the present invention.

权利要求:
Claims (15)
[0001]
1. A fixation device (20) for dispensing surgical fasteners, comprising: a lower arm (22) having a proximal end (24), a distal end (26) and a longitudinal axis extending between the distal and proximal ends an upper arm (36) connected with said lower arm and having a distal end (40) opposite the distal end of the lower arm; an actuator coupled to the upper and lower arms for moving the distal ends of the upper and lower arms one at a time. towards each other in order to close the clamping device; and a surgical clamp dispenser (28) secured to the distal end of the lower arm, the surgical clamp dispenser including a cartridge body (76) having a top surface (83) with a surgical clamp dispenser opening (84); wherein the surgical fastener dispenser is adapted to dispense surgical fasteners (78) from the cartridge body; characterized in that a block (42) pivotally connected to the distal end of the upper arm, the block has a bottom surface ( 154) which opposes opening the dispenser, wherein when the fixture is closed, the bottom surface of the block applies a locking force through tissue onto the top surface of the cartridge body to dispense one of the surgical clips to from the dispenser opening.
[0002]
2. Fixing device (20), according to claim 1, characterized in that the actuator comprises: a manual handle (32) attached to the lower arm; a trigger (34) mounted on the lower arm and connected to the upper arm, the trigger being adapted to be pulled towards the hand grip to close the clamping device and move in the opposite direction to the hand grip to open the hand grip. attachment, wherein the actuator further comprises an actuator return spring (62) coupled to the actuator to normally urge the actuator to move in the opposite direction to the manual grip, the actuator further comprises a rack and pinion system connecting the actuator to the upper arm, the rack and pinion system including a rack (52) having teeth (56) that slide along the longitudinal axis of the lower arm and a pinion (60) at the proximal end of the upper arm, the pinion having teeth (58 ) which merge with the teeth on the rack.
[0003]
3. Fixing device (20) according to claim 1, characterized in that the surgical clamp dispenser comprises: a support tray (68) having a proximal end (70) connected to the distal end of the lower arm , and a distal end (72) that includes an insertion fork (74) that extends along an axis that is perpendicular to the longitudinal axis of the lower arm; the cartridge body overlying the support tray, the cartridge body having a proximal end (80) pivotally connected to the proximal end of the support tray, and a distal end (82) freely movable relative to the distal end of the support tray, the top surface of the cartridge body extending between the ends distal and proximal of the cartridge body and the dispenser opening being in alignment with the insertion fork; and a cartridge body return spring (88) in contact with the cartridge body and the support tray to normally urge the distal end of the cartridge body in the opposite direction from the support tray, wherein the surgical fasteners are arrayed in a series to be dispensed one at a time from the dispenser opening, and wherein each of the surgical fasteners has an insertion end oriented towards the top surface of the cartridge body.
[0004]
4. Attachment device (20) according to claim 3, characterized in that the cartridge body return spring engages the cartridge body and the support tray to normally urge the top surface of the cartridge body in a plane that is parallel to the longitudinal axis of the lower arm.
[0005]
5. Fixing device (20) according to claim 3, characterized in that the surgical fasteners extend along planes that are parallel to each other and perpendicular to the longitudinal axis of the lower arm, in which the fastener dispenser surgical fastener further comprises a surgical fastener advance spring (92) coupled to the surgical fasteners to urge the surgical fasteners toward the distal end of the cartridge body, wherein the surgical fastener advance spring is adapted to advance a first fastener among the surgical fasteners (78A) for engagement with the insertion fork at the distal end of the support tray to be dispensed through the dispenser opening of the cartridge body.
[0006]
6. Fixing device (20) according to claim 5, characterized in that the insertion fork is adapted to retain and dispense the surgical fasteners along a fixed angle to the longitudinal axis of the lower arm.
[0007]
7. Attachment device (20) according to claim 6, characterized in that the cartridge body is pivotable between an extended position in which the top surface of the cartridge body is parallel to the longitudinal axis of the lower arm and a compressed position in which the top surface of the cartridge body is angled with respect to the longitudinal axis of the lower arm, and in which the cartridge body return spring is compressed when the cartridge body is in the compressed position.
[0008]
8. Fixing device (20) according to claim 7, characterized in that the first surgical clamp and the insertion fork are covered by the cartridge body when the cartridge body is in the extended position, and the first clamp The surgical insert and the insertion fork are at least partially exposed through the dispenser opening when the cartridge body is in the compressed position, wherein the cartridge body comprises a spacer (86) projecting from a distal end ( 82) therefrom that extends beyond the distal end of the support tray to space the dispenser opening from a more distal end of the surgical clamp dispenser.
[0009]
9. Fixing device (20) according to claim 1, characterized in that the upper arm is curved and has a concave surface that is opposite the lower arm.
[0010]
10. Attachment device according to claim 1, characterized in that the block comprises a marker (182) accessible to said bottom surface thereof that is aligned to the dispenser opening when the attachment device is closed, wherein the marker is adapted to produce a visual indicator on a patient's outer skin surface that mirrors the location of one of the surgical fasteners inserted into the patient's inner surface.
[0011]
11. Clamping device according to claim 1, characterized in that the block comprises a bevelled washer (160) adapted to generate an audible clicking sound when the clamping force between the block and the cartridge body reaches a predetermined level.
[0012]
12. Attachment device for dispensing surgical fasteners, characterized in that it comprises: an upper arm hingedly connected with the lower arm; an actuator coupled to the upper and lower arms to move the distal ends of the upper and lower arms towards the other to close the clamping device to generate clamping force therebetween; a surgical clamp dispenser adapted to dispense the surgical clamps one at a time; and when the clamping device is closed the bottom surface of the block applies clamping force onto the top surface of the surgical clamp dispenser to dispense one of the surgical clamps along an axis which is perpendicular to the longitudinal axis of the lower arm.
[0013]
13. Clamping device (20) according to claim 12, characterized in that the block comprises a marker (182) accessible on the bottom surface thereof which is aligned to the dispenser opening when the clamping device is closed and which is adapted to produce a visual indicator on an outer surface that matches the location of one of the surgical fasteners inserted into an inner surface.
[0014]
14. Fixing device (20) according to claim 12, characterized in that the surgical clamp dispenser comprises: a support tray (68) having a proximal end (70) connected to the distal end of the lower arm , and a distal end (72) including an insertion fork (74) that extends along an axis that is perpendicular to the longitudinal axis of the lower arm, a cartridge body (76) overlying the support tray, the body. cartridge having a proximal end (70) pivotally connected to the proximal end of the support tray, a distal end (82) freely movable relative to the distal end of the support tray, a top surface (83) extending between the distal and proximal ends of the cartridge body, and the surgical clamp dispenser opening (84) formed in the top surface and is in alignment with the insertion fork, and a body return spring of cartridge (88) in contact with the cartridge body and support tray to normally urge the distal end of the cartridge body away from the support tray.
[0015]
15. Fixing device (20) according to claim 14, characterized in that it further comprises the plurality of surgical fasteners disposed within the cartridge body, wherein the surgical fasteners are arrayed in a series to be dispensed one at a time from the dispenser opening, and wherein each of the surgical fasteners has an insertion end oriented towards the top surface of the cartridge body, wherein when the fixture is closed, the bottom surface of the block applies clamping force on the top surface of the cartridge body, and wherein the cartridge body is pivotable between an extended position in which the top surface of the cartridge body is parallel to the longitudinal axis of the lower arm and a compressed position in which the top surface of the cartridge body is angled with respect to the longitudinal axis of the lower arm.

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同族专利:

公开号 | 公开日

RU2014141640A|2016-05-10|

CN104168841B|2017-06-09|

MX353895B|2018-02-01|

RU2627149C2|2017-08-03|

US9119617B2|2015-09-01|

CA2867497A1|2013-09-19|

JP6141401B2|2017-06-07|

JP2015512276A|2015-04-27|

BR112014022894A2|2017-06-20|

EP2825102A1|2015-01-21|

NZ629201A|2015-05-29|

MX2014011102A|2014-12-05|

WO2013138629A1|2013-09-19|

AU2013232039A1|2014-10-23|

AU2013232039B2|2017-02-16|

CN104168841A|2014-11-26|

CA2867497C|2020-04-21|

EP2825102B1|2018-04-25|

US20130245642A1|2013-09-19|

IN2014DN07759A|2015-05-15|

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法律状态:
2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

2019-12-31| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2021-07-13| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2021-08-24| 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 14/03/2013, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

US13/421,975|2012-03-16|

US13/421,975|US9119617B2|2012-03-16|2012-03-16|Clamping devices for dispensing surgical fasteners into soft media|

PCT/US2013/031532|WO2013138629A1|2012-03-16|2013-03-14|Clamping devices for dispensing surgical fasteners into soft media|

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