Device for deploying tissue fasteners

Abstract

The present invention relates to a handheld surgical device operable by a single user for deploying fasteners to close a wound or incision in tissue. The device includes tissue clamping and folding members operably controlled by a user during actuation of a trigger of the device, which may temporarily fasten and expose inner surfaces of both edges of an incision or wound, where one of a plurality of fasteners may be inserted upon further actuation of the trigger, and the other of the plurality of fasteners may be inserted upon further actuation of the trigger. And the tissue cannot be crushed or inappropriate trauma cannot be caused to the tissue.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 318,967, filed on March 11, 2022, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] The present invention relates generally to medical devices and, more particularly, to medical devices that deploy bioabsorbable fasteners into tissue to fasten two sides of an incision or wound in the skin of a patient. Background Art

[0004] There are many examples of surgical staplers that deliver staples into tissue to hold closed incisions or cuts for healing. Most surgical staplers deliver traditional metal staples that rely on the strength of the staples to pierce tissue and hold tissue surfaces together. One of the shortcomings of metal staples is that it must have a portion that remains exposed through the skin surface to allow medical professionals to remove the fasteners when biological healing is complete. This exposed portion is unsightly, and the puncture point where the fastener enters the skin has a risk of infection.

[0005] In order to solve the shortcomings of metal staples, different inventors have proposed fasteners made of bioabsorbable materials, which can be placed under the skin surface. This subcutaneous skin closure avoids puncturing the epidermis and does not require the subsequent removal of staples. For example, the U.S. Patent No. 6,726,705 entitled "Mechanical Method and Apparatus for Bilateral Tissue Fastening" granted to Peterson et al. ("Peterson") describes this solution. The device proposed by Peterson uses a drive head, which is positioned at least partially below the outer surface in the incision. The tissue manipulator compresses the two sides of the tissue into the concave area of ​​the drive head so that the piercing member can cut a hole in the target tissue area to insert the fastener. After the fastener is deployed, the drive head is removed so that the fastener is engaged in the tissue on both sides.

[0006] The cross section of the fastener embodying Peterson's invention is much thicker than the cross section of metal staples. It is necessary to make the bioabsorbable fastener strong enough to maintain the traditional U-shape of staples during the healing process. This increased volume is undesirable, and it is necessary to cut holes in the target tissue area to insert the piercing member of the fastener. This cutting of tissue can cause trauma and bleeding, which may affect the healing process. In addition, the stapler embodying Peterson's invention needs to partially insert the driver head into the incision, and compress the tissue into the concave area of ​​the driver head. For short incisions (such as those adopted in minimally invasive surgery), it is inappropriate to use a device based on Peterson, because once the fastener is deployed to hold the closed incision, the driver head may be captured inside the incision. Therefore, the stapler embodying Peterson has shortcomings and limitations.

[0007] More recently, U.S. Pat. No. 8,506,591, entitled “Tissue Fasteners and Related Insertion Devices, Mechanisms, and Methods,” issued to Danielson et al. (“Danielson”), describes a handheld stapler that deploys bioabsorbable fasteners without placing a driver head inside an incision. Additionally, Danielson teaches a surgical needle extending through the legs of the fastener with a sharp tip exposed distally, which aids in the fastener entering the tissue with minimal cutting and bleeding. However, this insertion mechanism has not gained acceptance in the surgical community, perhaps because it requires two people to operate the device, including a first person using forceps in each hand to evert the sides of the incision, and a second person is required to operate the stapler. Summary of the invention

[0008] The present invention addresses the shortcomings of current staplers. In particular, the surgical device of the present invention can be operated by a single user and is capable of deploying bioabsorbable fasteners of the type described by Danielson that are very small and low mass to minimize foreign material in the wound, and the surgical device is also capable of closing incisions or wounds as short as 10 mm. In addition, in some embodiments, the device includes a surgical needle extending through the legs of the fastener, wherein the sharp tip is exposed distally, which helps when used to insert the bioabsorbable fastener to secure the two sides of the incision or wound, allowing the fastener to enter the tissue with minimal cutting, bleeding, or trauma to the tissue.

[0009] In particular, the surgical device of the present invention can be everted and hold tissue from each side of an incision or wound, and one or more bioabsorbable fasteners are inserted into the subcutaneous tissue to hold two edges together. For example, the device includes a housing that directs and constrains other elements of the device. The housing includes a body having a handle element and a barrel element. The barrel of the housing has a proximal end and a distal end and an axis extending from the proximal end through the center of the barrel to the distal end. The barrel element and the handle element are connected at an angle that facilitates the user to hold the handle with one hand and position the barrel so that the axis is substantially perpendicular to the skin surface and points to the incision. The handle element includes a trigger that extends from the housing at the barrel and handle junction, and the trigger can be moved toward the handle by the squeezing action of the user's hand, and is used as an actuator for the moving element of the device. The distal element of the trigger is contained in the housing, and the barrel element and the handle element are connected at the housing.

[0010] The cartridge element includes a fastener delivery mechanism that includes a plurality of fasteners contained within a cartridge. The cartridge includes a cover for forming an outer cover that includes a plurality of fasteners and other components (e.g., a pusher, a pusher spring, a fastener support, and a fastener support spring). The fastener delivery mechanism includes mechanical components (e.g., a plunger needle assembly, a timing lever, a timing lever spring, and an insertion device) to release the fasteners one by one when a user operates a trigger.

[0011] The distal end of the barrel element includes an introducer with a shaped feature that helps the user manipulate tissue while holding the device in one hand and holding the forceps in the other hand. The introducer includes a retractor finger that can engage an apex of the incision and can be pulled to produce traction on the tissue held at the other apex by the forceps. When the tissue is placed in a traction state, the two edges of the incision are aligned and can be lifted above the plane of the skin surface. Once the tissue is lifted to cover the introducer, the removable tissue holder on each side of the barrel is operated by squeezing the trigger. These tissue holders each include forceps to help tighten the tissue. If the user wishes to reposition the tissue, the user can alternately squeeze and release the pressure on the trigger. Once the user is satisfied with the position of the tissue, continue squeezing the trigger to move the tissue holder so that the forceps tighten the two edges of the incision, and the legs make the tissue eversion and position it to insert the fastener.

[0012] In order to place the fastener in a short incision (including an incision less than 10mm long), the barrel element and the handle element are connected at an angle that helps the user to position the barrel substantially perpendicular to the skin surface and pointing to the incision. The introducer and tissue retainer are configured so that the short incision can be fastened and the fastener is fully deployed on the far side of the tissue retaining device. This novel combination of elements of the present invention allows the user to deploy the fastener straight down into the short incision, and then simply lift the device from the position. This creative configuration avoids the risk of the device being trapped in the closed incision, which has occurred in devices including tissue retaining elements that must be positioned in the incision, away from the fastener.

[0013] When only holding tissue from the proximal side of the insertion force, there is a risk that the tissue stretches away from the holding component and is not pierced. The present invention teaches a shaped end for forceps that reduces stretching and fastens tissue with minimal trauma. The width of the forceps is 4mm to 8mm, and the forceps include sharp protrusions on either side of the fastener path with space between these protrusions. Compared with single-point traditional tweezers, the separation of the sharp protrusions reduces the stretching of the tissue. The forceps arms also contribute to the atraumatic holding of the tissue, and the forceps arms allow movement in multiple dimensions. The movement of the forceps arms works in conjunction with the surface (called clamping rail) against which the clamped tissue of the introducer abuts to have the following effect: as the fastener piercing force attempts to pull the tissue away, the engagement of the forceps on the tissue is enhanced. As a result, compared with competitive tissue manipulators, the stretching of the tissue is reduced and the adaptive holding force is smaller, and the force per unit area is smaller.

[0014] In the present invention, the sequential steps of clamping tissue and deploying fasteners are all controlled by squeezing a single trigger. To achieve this, the present invention includes a novel slider-crank assembly of interrupted motion, which is used to transfer force from the trigger to the tissue retainer and the insertion device. During the initial movement, a slider-crank mechanism similar to a slider-crank mechanism known in the art transfers force from the trigger to the tissue retainer. During the second stage, the downward force on the proximal end of the slider is transferred as a lateral force, which moves the proximal end of the slider along the angled surface. This movement produces a downward force on the slider, and due to the mechanical advantage of the two mating angled surfaces (inclined surfaces), a significant distal force is generated. This mechanical advantage allows the user who is squeezing the trigger to securely fasten the tissue between the forceps and the guide. During the third stage, the movement of the slider is "interrupted" by converting the proximal end of the slider into a latch, so that the slider and the tissue retainer stop moving, and the user continues to squeeze the handle, thereby operating on the insertion device to deliver the fastener to the tissue.

[0015] In one embodiment of the present invention, a ratchet mechanism may be included that allows the user to reopen the forceps to reposition on tissue, but then requires the user to complete fastener placement before allowing the trigger to return to its starting position. The ratchet mechanism is preferably designed to be overcome by the user in the event of a jam of the mechanism. Types of ratchets include a spring-loaded pawl on serrations, a flexible metal sheet that slides on a cam or serrations, or other ratchet mechanisms known to those skilled in the art.

[0016] In an alternative embodiment of the present invention, the risk of tissue stretching is mitigated by increasing the speed of the insertion mechanism. A speed of about 6m / s to 7m / s and a kinetic energy of about 0.15Nm to 0.2Nm yield good penetration with minimal stretching. Needle insertion products (such as insulin pumps and automatic injection delivery devices) are known in the prior art. These devices require separate actions to preload the spring and then trigger / excite the device. Other mechanisms (such as those described in U.S. Patent No. 10,918,381) directly impact fasteners with high-speed drivers. In order to deploy bioabsorbable fasteners of the type described by Danielson, each fastener must be installed on the insertion needle in the first step. Attempting to install the fastener on the needle at high speed has the risk of jamming the mechanism. Therefore, the first step must be performed at a moderate speed before acting on the insertion device with a high-speed delivery system. To achieve this, the alternative embodiment includes a multi-speed spring-loaded delivery mechanism.

[0017] At the beginning of the deployment of the fastener, the driver head is moved forward at a moderate speed by squeezing the trigger by the user. The driver head acts indirectly on the plunger needle assembly through the compression spring. As the plunger needle assembly moves distally, the plunger needle assembly inserts the needle into the frontmost fastener in the fastener stack. Once the fastener is installed on the needle, the trigger-stop mechanism stops the movement of the plunger needle assembly. Continued squeezing of the trigger causes the spring to be compressed, thereby storing energy for use when inserting the fastener. The release element releases the spring to deliver its stored energy to the insertion device, thereby pushing the fastener to quickly contact the dermal tissue at a speed of more than 6m / s. After insertion, the user releases the trigger and pulls the driver head upward, thereby returning all elements to their starting positions.

[0018] Thus, the device of the present invention can be operated by a single user to assist in inserting one or more bioabsorbable fasteners of the type described by Danielson for closing incisions and wounds (including small incisions, such as incisions less than 10 mm long). For example, the device includes a shaped distal member configured to engage one vertex of the incision to provide traction to resist the force from the force of the forceps applied at the other vertex and operated by the user's other hand, thereby providing an improved means of achieving the ultimate goal of closing the incision or wound without the assistance of another person. The device further includes tissue clamping and folding members that are operably controlled by the user during actuation of the trigger of the device, which tissue clamping and folding members can temporarily fasten and expose the inner surfaces of both edges of the incision or wound, wherein one of the multiple fasteners can be inserted upon further actuation of the trigger without crushing the tissue or causing undue trauma to the tissue, and further assisting a single user in accurately deploying the fastener to the intended target.

[0019] In one aspect, the present invention provides a handheld surgical device for deploying bioabsorbable fasteners to close a wound or incision in a tissue. The device includes a body, the body including a handle element and a barrel element, the handle element including a user-actuable trigger, the barrel element including a distal end for positioning one or more fasteners relative to the wound or incision in the tissue. The device further includes a tissue clamping and folding assembly, the tissue clamping and folding assembly is positioned adjacent to the distal end of the barrel element and operably connected to the trigger, wherein, when the distal end of the barrel element is placed relative to the wound or incision and in response to the user's actuation of the trigger, the tissue clamping and folding assembly is configured to temporarily fasten the relative edges of the wound or incision relative to the distal end of the barrel element and physically evert the relative edges of the wound or incision to prepare for the deployment of one or more fasteners in a plurality of fasteners. The device further includes a fastener delivery mechanism, the fastener delivery mechanism is operably connected to the trigger and is configured to deploy one or more bioabsorbable fasteners in a plurality of bioabsorbable fasteners from the distal end of the barrel element in response to the user's actuation of the trigger.

[0020] In some embodiments, the fastener delivery mechanism is configured so that a given fastener extends outward and away from the distal-most end of the tissue clamping and folding assembly and the distal-most end of the barrel and subsequently penetrates the opposing edges of the wound or incision so that the fastener is fully deployed distally of the device and delivered beneath the surface of the tissue.

[0021] The tissue clamping and folding assembly can generally include: 1) an introducer positioned at and extending from the distal end of a barrel element, the introducer comprising an elongated body configured to directly contact opposing edges of a wound or incision; and 2) a pair of opposing tissue retainer elements positioned at the distal end of the barrel element and on opposite sides of the elongated body of the guide, each tissue retainer comprising a jaw member and a foot member configured to move cooperatively relative to the guide in response to actuation of a trigger by a user.

[0022] The elongated body of the introducer may include a pair of clamping rails extending along opposite sides of the elongated body. Each tissue retainer element may include a clamp element and a leg element, wherein, in response to actuation of the trigger by the user, the clamp element is adapted to clamp and fasten a portion of a corresponding edge of the wound or incision against the corresponding clamping rail, and the leg element is adapted to evert a portion of the corresponding edge of the wound or incision, thereby positioning the inner surface of the corresponding edge for subsequently receiving a portion of the fastener. For example, each clamp may include one or more sharp protrusions.

[0023] The introducer may include an exit port through which at least the fastener passes in response to actuation of the trigger by a user during operation of the fastener delivery system. The leg elements of each tissue retainer element are generally adapted to expose the inner surface of a corresponding edge of the wound or incision relative to the exit port of the introducer so that a deployed fastener passing through the exit port can bilaterally engage the opposite edges of the wound or incision and thereby retain the edges together.

[0024] The trigger is operably coupled to the pair of tissue retainer elements and the fastener delivery mechanism by independent connections, thereby allowing sequential operation thereof.

[0025] Like this, the user actuates the trigger to the initial first position and can make the jaws of each tissue retainer element rotate inwardly toward the introducer and further clamp and fasten a part of the corresponding edge of the wound or incision against the corresponding side of the introducer. In addition, the user actuates the trigger to the subsequent second position and can make the leg members of each tissue retainer element rotate inwardly toward the introducer and further evert a part of the corresponding edge of the wound or incision, thereby positioning the inner surface of the corresponding edge for subsequently receiving a part of the fastener. Finally, the user actuates the trigger to the subsequent third position and can make the fastener delivery mechanism operate, thereby causing the deployment fastener to engage the relative edges of the wound or incision bilaterally, and thus the edges are held together.

[0026] In some embodiments, each tissue retainer element can be injection molded from a single material.For example, in some embodiments, the jaw member and the foot member of each tissue retainer element are integrally formed with each other.

[0027] In some embodiments, the jaw members and foot members of each tissue retainer element may be formed of different materials and assembled to cooperatively form a given tissue retainer element.

[0028] The jaw member and the foot member may be generally movable relative to each other.

[0029] In some embodiments, the device further includes a pair of slider elements, each slider element having a proximal end operably connected to the trigger and a distal end operably connected to a corresponding one of a pair of tissue retainer elements, such that actuation of the trigger causes movement of the pair of slider elements, which action in turn causes corresponding movement of a pair of opposing tissue retainer elements.

[0030] In some embodiments, the introducer may further include a retraction finger positioned at one end of the elongated body and adapted to engage a first apex of the wound or incision, thereby providing an opposing traction force applied at a second apex of the wound or incision.

[0031] The fastener delivery mechanism can be generally configured to retain a plurality of fasteners and further include one or more insertion needles configured to releasably engage and deploy each of the plurality of fasteners in a one-by-one manner in response to repeated actuation of a trigger by a user.

[0032] It should be noted that in some embodiments, each of the plurality of fasteners comprises a first leg, a second leg, and a flexible bridging member connecting the first leg and the second leg. In some embodiments, each leg can be completely cannulated, so that the fastener delivery mechanism is configured to releasably engage and deploy the corresponding insertion needle of each of the plurality of fasteners can pass through each corresponding leg, so that the sharp end of the insertion needle is exposed to the distal side. For example, the trigger can be operably connected to the plunger-needle assembly, which includes two insertion needles, which are parallel to each other and are configured to pass through the corresponding legs of the fastener. In this way, in response to the user's actuation of the trigger, the plunger-needle assembly can engage the insertion needle with the fastener and simultaneously penetrate the opposite edges of the wound or incision to insert the fastener, and in response to the user releasing the trigger, the plunger-needle assembly completely moves the insertion needle away from the fastener at the distal end of the device and below the tissue surface.

[0033] In other embodiments, each leg can be partially cannulated in that the passageway in each leg does not extend completely through each leg but only partially within each leg. Thus, in such embodiments, the corresponding insertion needle of the fastener delivery mechanism passes within a portion of the corresponding partially cannulated leg of the fastener, and the sharp end is not exposed distally but remains within the passageway of the corresponding leg. For example, the trigger can be operably coupled to a plunger-needle assembly, which includes two insertion needles that are parallel to each other and are configured to pass within a portion of the corresponding partially cannulated leg of the fastener, and in response to the user's actuation of the trigger, the plunger-needle assembly causes the insertion needles to engage the fastener, thereby causing each leg of the fastener to penetrate the opposite edge of the wound or incision, thereby inserting the fastener, and in response to the user releasing the trigger, the plunger-needle assembly causes the insertion needles to completely move away from the fastener at the distal end of the device and below the tissue surface.

[0034] The fastener delivery mechanism may be generally configured to receive and hold a magazine including a plurality of stacked fasteners, and the plunger-needle assembly is configured to releasably engage a forward-most fastener disposed in the fastener stack via a pair of insertion needles for subsequent deployment.

[0035] In some embodiments, the fastener delivery mechanism may include a spring-driven delivery assembly. The spring-driven delivery assembly may include a plunger-needle assembly configured to releasably engage a frontmost fastener in a stack of fasteners disposed in a cartridge; a drive head operatively coupled to a trigger and the plunger-needle assembly, wherein the drive head is configured to indirectly move the plunger-needle assembly by action on a drive spring; a stop mechanism including a trigger configured to engage a corresponding stop and thereby prevent movement of the plunger-needle assembly when the drive head moves to a first drive head position; and a release element adapted to disengage the trigger from the corresponding stop when the drive head moves to a second drive head position.

[0036] Accordingly, in such an embodiment, the user actuates the trigger to an initial first position causing the drive head to move to a first drive head position and the plunger-needle assembly to engage the forward-most fastener. Next, the user actuates the trigger to a subsequent second position causing the drive spring to compress and causing the drive head to move to a second drive head position, causing the plunger-needle assembly to be driven via the force applied from the compressed drive spring when the trigger is disengaged from the corresponding stop, thereby deploying the fastener and delivering the fastener into the tissue at a significantly faster speed than the movement of the trigger. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] In the drawings, like reference numerals generally refer to like parts throughout the different views. Where components are symmetrical, numbered features will be labeled with "a" for the left side and "b" for the right side, but in the text, these symmetrical elements will be identified as "a, b" even if only one component is visible in a particular drawing. Also, the drawings are not necessarily drawn to scale, with emphasis instead generally being placed upon illustrating the principles of the invention.

[0038] Figure 1 A perspective view of an embodiment of the assembly apparatus of the present invention is shown.

[0039] Figure 2 The present invention Figure 1 A partially exploded perspective view of an embodiment of the present invention shows the major subassemblies.

[0040] Figure 3 Shown in exploded view Figure 2 Elements of an embodiment of a fastener delivery mechanism.

[0041] Figure 4 is a close-up view of an embodiment of an introducer.

[0042] Figure 5 A typical skin incision is shown with an embodiment of the present invention positioned for closure.

[0043] Figure 6 yes Figure 1 A perspective view of an embodiment of a tissue retainer of a device.

[0044] Fig. 7A yes Figure 1 A front view of the distal end of the barrel of the device and a partial cross-section of tissue showing the position of the tissue retainer when the user squeezes the trigger to the first position.

[0045] Figure 7B The display shows the state of the trigger after the user squeezes the trigger to the second position. Fig. 7A Embodiment of a front view of the device and tissue.

[0046] Figure 7C The display shows the state after the user squeezes the trigger to the third position. Figure 7B An embodiment of a front view of a device and tissue showing a cross-section of the fastener and tissue after the fastener is deployed into the tissue.

[0047] Figure 8 Shown assembled with selected components Figure 1 An embodiment of a left housing shell of a device.

[0048] Fig. 9A , Fig. 9B , Fig. 9Cand Fig.9D Shows Figure 8 A view of a portion of the device outlined in FIG. 1 and a partial cross-section of the trigger to illustrate the movement of the components when the trigger is squeezed by a user.

[0049] Fig. 10A , Fig. 10B and Fig. 10C Selected components are shown removed from an embodiment of the device to illustrate the movement of the components when a user squeezes the trigger.

[0050] Fig.11 Alternative embodiments of the invention are shown that include additional components.

[0051] Fig. 12A , Fig. 12B , Fig. 12C , Fig.12D and Fig.12E A series of steps are shown in Fig.11 0026] An embodiment of an additional component highlighted in FIG. 1 to illustrate the movement of the components when a user squeezes the trigger.

[0052] For a thorough understanding of the present disclosure, reference should be made to the following detailed description including the appended claims in conjunction with the above-mentioned drawings. Although the present disclosure is described in conjunction with exemplary embodiments, the present disclosure is not intended to be limited to the specific forms listed herein. It should be understood that various omissions and equivalents can be envisioned as these circumstances may indicate or appear to be advantageous. DETAILED DESCRIPTION

[0053] By way of overview, the present invention relates to a medical device for deploying fasteners into tissue to fasten two sides of an incision or wound in the skin of a patient. In particular, the present invention provides a handheld surgical device that can be operated by a single user for delivering fasteners for closing a wound or incision. The device provides tissue clamping and folding members integrated into the device and controlled by the user, which can temporarily fasten and expose the inner surfaces of two edges of an incision or wound to be inserted with fasteners without crushing the tissue or causing undue trauma to the tissue.

[0054] It should be noted that the device of the present disclosure is configured to deploy and insert fasteners of the type having two cannulated legs into tissue using a similar tissue insertion procedure / step as set forth in Danielson, but further includes a novel and innovative delivery mechanism that provides many advantages and addresses the shortcomings of current stapler devices similar to Peterson and Danielson. It should be further noted that other types of bioabsorbable fasteners may also be used with the disclosed device and deployed by the disclosed device. The present invention further includes certain mechanical elements for deploying a given fastener, similar to those described in the commonly assigned U.S. Patent No. 9,232,943 entitled "Delivering Bioabsorbable Fasteners" to Rogers and Milea ("Rogers"), the contents of which are incorporated herein by reference in their entirety.

[0055] Figure 1 A perspective view of an embodiment of a device 100 for inserting a bioabsorbable fastener to fasten two sides of an incision in tissue is shown. The device includes a housing 110 having a handle 115 and a barrel 117 connected at an angle. A trigger 119 extends from the housing, which can be moved toward the handle 115 by a squeezing action of the user's hand and serves as an actuator for the moving element of the device.

[0056] The barrel of the housing has a proximal end and a distal end and an axis extending from the proximal end through the center of the barrel to the distal end. For the purpose of this specification, the proximal end is at the upper left of the figure and the distal end (the end farthest from the user) is at the lower left of the figure. The barrel element and the handle element are connected at an angle that facilitates the user to hold the handle with one hand and position the barrel 117 so that the axis is substantially perpendicular to the skin surface and points to the incision. The user operates the device by manually squeezing the trigger 119 so that the trigger is pulled back toward the handle.

[0057] The trigger is operably connected to the sliders 125a, 125b on each side of the barrel 117. The tissue retainers 130a, 130b described in detail below include tissue retainer pivot pins, which are rotatably attached to the housing 110 by positioning the pins in the recesses in the housing shell. The tissue retainers 130a, 130b also include tissue retainer push rods, which are rotatably connected to the distal ends of the sliders 125a, 125b. The movement of the slider transmits force from the trigger 119 to the tissue retainers 130a, 130b. At the distal end of the barrel, the device includes an introducer element 135 that is usually in the form of a projection. The introducer 135 acts together with the tissue retainers 130a, 130b to position and retain tissue for inserting fasteners.

[0058] Figure 2 The invention is shown in an exploded view. Figure 1 The device 100 includes a left housing shell 112 and a right housing shell 113 that are assembled together to form a housing that orients and constrains the other elements of the device.

[0059] The device includes a fastener delivery mechanism 140, which includes a plurality of fasteners contained within a cartridge. As described in detail below, the fastener delivery mechanism includes mechanical elements to release the fasteners one by one when the user operates the trigger 119. In some embodiments, the mechanical elements of the fastener delivery mechanism are similar to those described in Rogers and interact with the fasteners in a substantially similar manner. A plunger-lever 143 transfers force from the trigger 119 to a plunger-needle assembly 145 of the fastener delivery mechanism 140. A spring 141 provides a restoring force to return the trigger to its starting position when the squeezing pressure is released.

[0060] As described in detail below, the tissue retainers 130a, 130b also include a tissue retainer push rod that can be rotatably connected to the distal end of the sliders 125a, 125b.

[0061] Figure 3 Shown in exploded view Figure 2 140. The components of the fastener delivery mechanism are contained in two housings: a delivery mechanism left housing 147 and a delivery mechanism right housing 149. When the two housings are assembled, they guide the plunger needle assembly 145 so that it can move in response to the plunger lever 143 (not shown) and cooperate with the other components of the assembly to deliver fasteners one at a time. Figure 3 The parts shown in Figure 3 , Figure 4 and Figure 5 Like parts in Rogers have like reference numerals and are generally of the same form, fit and function as described in Rogers. In the present invention, the plunger 40 with the needle 65 described by Rogers is replaced by a plunger needle assembly 145 and is modified to replace the manually actuated thumb pad with a connection to a plunger lever 143. The guide tube support 73 and needle guide tube 67 described in Rogers are renamed as insertion device 146, but the same function is maintained.

[0062] As described in detail in Rogers, the fastener delivery system 140 includes a cassette cover 215 that is assembled with the cassette 200 to form a housing containing a plurality of fasteners. The fasteners are positioned on a reciprocating fastener support 270 that is connected to a pusher 275, a pusher spring 277, and a fastener support spring 287 to advance the fasteners shown as first fasteners 50a and second fasteners 50b. The needle guide tube and the leg of the front-most fastener are in slidable contact with at least one alignment surface that is configured to axially align with the needle guide tube and the leg of the front-most fastener. The two needles in the needle guide tube are actuated to insert each needle into the cannulated leg. The timing lever 150 connected to the lever support spring 155 acts on the fastener support 270 in unison with the actuator movement to remove support for the front-most (also referred to herein as "front-most") fastener after needle insertion. The needle guide tube transmits force to the fastener to push it out of the magazine to insert the fastener into the tissue.

[0063] The fastener may be of the type described in, for example, Danielson, wherein the fastener comprises a bridging section and two cannulated leg sections. The bridging section comprises a first portion and a second portion. The first leg section is integral with the bridging section and extends from the first portion of the bridging section. At least a portion of the first leg section defines a first lumen extending therethrough, such that the first leg section is cannulated. The second leg section is also integral with the bridging section, and the second leg section extends from the second portion of the bridging section. At least a portion of the second leg section defines a second lumen extending therethrough, such that the second leg section is also cannulated. The bridging section and the first and second leg sections comprise a single piece of material.

[0064] Figure 4Features of an embodiment of an introducer 135 are shown, which is located at the distal end of the fastener delivery mechanism 140. The introducer includes an outlet 290, which is a specially shaped opening that guides the distal end of the plunger-needle assembly 145 as it leaves the fastener delivery mechanism 140 carrying the fastener. The introducer 135 also has features that help manipulate and position tissue. The elongated body of the introducer includes a retractor 292 or retractor finger at one end and a point 293 at the opposite end. The retractor can engage one vertex of the incision and be pulled by the force applied by the user when positioning the device to create traction on the tissue held at the other vertex by the forceps. When the tissue is placed in traction, the two edges of the incision are aligned and can be lifted above the plane of the skin surface. When in use, the longer dimension of the introducer 135 is aligned with the incision. Clamping rails 295a, 295b extend along each side of the introducer 135 from point 293 to the retractor 292. As described in detail below, when the sides of the incision are lifted, the inner surface of the tissue contacts the introducer 135 and folds around the clamping rails to hold the tissue in place.

[0065] Figure 5 An embodiment of the present invention is shown in contact with an opening 305 in skin tissue 303, which may represent the present invention in use. The introducer 135 is covered by the lifted tissue, the retractor 292 (not visible) is engaged at the vertex of the incision on the right side of the figure, and the forceps 320 pull at the other vertex to create traction on the tissue edges 310a, 310b. When the tissue is placed in traction, the two edges 310a, 310b of the opening or incision are aligned and can be lifted above the plane of the surface of the skin tissue 303. When the two sides of the incision are as shown Figure 5 When lifted as shown, the inner surface of the tissue contacts the introducer 135 and folds around the clamping rails 295a, 295b (not visible).

[0066] Figure 6 An embodiment of one of the tissue retainers 130a, 130b is shown, and for the purpose of this specification, the tissue retainer is displaced with its position of being movably attached to the side of the barrel 117. Each tissue retainer includes a tissue retainer pivot pin 350a, 350b, which is rotatably attached to the housing 110 by positioning the pin in the recess of the housing shell. Each tissue retainer 130a, 130b also includes a tissue retainer push rod 355, which can be rotatably connected to the distal end of the slider 125a, 125b. Each tissue retainer 130a, 130b further includes a forceps 330a, 330b and a leg 340a, 340b.

[0067] Each forceps 330a, 330b includes a sharp protrusion or tooth 335 at the distal end, which is generally directed toward the introducer (not shown). Two rows of teeth 335 are advantageously positioned at the distal end of the forceps, with spaces between the teeth. The space between the teeth 335 is aligned with the path (N) of the fastener, and has the effect of enhancing the engagement of the teeth when the fastener penetration force pulls into the area between the teeth. The width (W) of the forceps exceeds 2 mm, preferably between 4 mm and 8 mm. The width (W) combined with the separated teeth reduces the stretching of the tissue compared to single-point conventional forceps. The forceps 330a, 330b are positioned at the ends of forceps arms 345a, 345b, which are attached to the tissue retainers 130a, 130b in a manner that allows the forceps to move relative to the tissue retainers. One direction of movement (a) allows the forceps 330a, 330b to move toward and away from the introducers 135a, 135b. The other direction of movement (b) allows the jaws 330a, 330b to move toward and away from the legs 340a, 340b. Fig. 7A and Figure 7B As shown, these two movements combine to capture tissue.

[0068] Fig. 7A 1 is a front view of the distal end of an embodiment of a barrel and a partial cross-section of tissue, showing the position of the tissue retainer when engaging the two tissue edges 310a, 310b of an opening in the skin tissue. In this figure, the tissue edges 310a, 310b have been positioned by a user such as Figure 5 The device is shown lifted, wherein the guide is covered by the lifted tissue, the retractor engages at one vertex of the incision (not shown), and the forceps pull at the other vertex (not shown) to create traction on the tissue edges 310a, 310b. The user squeezes the trigger to a first position, causing the sliders 125a, 125b to move distally. As the sliders move, the distal end of each slider pushes against the tissue retainer push rods 355a, 355b, causing the tissue retainers to rotate about the tissue retainer pivot pins 350a, 350b. The rotation of the tissue retainers 130a, 130b delivers force to the forceps 330a, 330b to engage the tissue, as shown. During the initial squeezing of the trigger, the user can release and reapply pressure to reposition the tissue, as shown in FIG. Fig. 9A Once the user is satisfied with the position of the tissue, continue squeezing the trigger to move the tissue retainer to Figure 7B Position shown.

[0069] Figure 7B The display shows the state of the trigger after the user squeezes the trigger to the second position. Fig. 7A295a, 295b and the legs 340a, 340b. The unique action of the forceps (capable of being used as a tool to hold the tissue) Figure 6 Movement in direction "b" as shown) increases the ability of the jaws to hold tissue as it is pulled distally by the insertion force of the fastener.

[0070] Figure 7C The display shows the state after the user squeezes the trigger to the third position. Figure 7B 1. A front view of the device shown in FIG. 1. In this position, the force applied distally by the plunger-needle assembly is applied to the insertion device 146 to fully deploy the fastener 50 into the two tissue edges 310a, 310b of the opening. After the fastener is deployed, the user immediately releases the pressure on the trigger and the needles 65a, 65b are retracted into the insertion device 146, causing the fastener 50 to engage in the tissue. At this point, the fastener 50 is completely away from all parts of the device, allowing the user to fully release the tissue retainers 130a, 130b and lift the device out of contact with the skin tissue 303 without the risk of being caught in the opening.

[0071] Figure 8 Shows Figure 1 1. The present invention provides an embodiment of a left housing shell 112 of a device that is assembled with only four (4) components: a trigger 119; a spring 141; a slider 125a; and a tissue retainer 130a. For the purposes of this specification, the other components of the device are removed. The trigger 119 rotates about a trigger pivot hole 360 ​​in response to a user squeezing the trigger. The trigger includes a bifurcated distal end within the housing, wherein each distal element has a curved cam track 370a, 370b. Each cam track acts on a slider pin 375 to transfer force from the trigger to the slider. Figure 8 The dotted line above indicates 9A to 9C Part of the apparatus further described in.

[0072] Fig. 9AA close-up view of a portion of an embodiment of the device in its initial position prior to user operation is shown. The trigger 119 is shown in partial cross-section to view only the components on the left side of the device, but the reader will understand that similar actions and component configurations occur with the elements on the right side of the device. In this figure, the distal element of the trigger 119 is shown as having a curved cam track 370a. The cam track 370a engages a slider pin 375a at the proximal end of the slider 125a. In response to the user squeezing the trigger, the distal element including the cam track 370a acts on the slider pin 375a to move the slider distally along the slider track 377.

[0073] Fig. 9B shows the trigger after it has moved to the first position Fig. 9A In this first position, if the user releases pressure on the trigger, the spring 141 reverses the rotation of the trigger and the cam track pulls the slider pin 375a toward its initial position, as shown in FIG. Fig. 9A As shown. The user can alternately squeeze and release pressure on the trigger, which causes the slider 125a to reversibly move back and forth along the slider track 377 to change the force of clamping the tissue. Once the user is satisfied with the position of the tissue, continue squeezing the trigger to move the component to Fig. 9C Configuration shown.

[0074] Fig. 9C shows the trigger after the user has moved it to the second position. Fig. 9B As the components move from the first position to the second position, the angled surface 380 at the proximal end of the slider 125a enters the latch 385, which is an angled recessed area in the housing shell. Contact with the cam track forces the slider 125a to slide against the angled surface of the latch to further move the slider distally. This sliding action transfers force to the slider with a significant mechanical advantage, allowing the user to squeeze the handle to have significant leverage to force the slider to its maximum distal position.

[0075] Fig.9D shows the trigger after it is fully squeezed. Fig. 9C The trigger has rotated but the slider remains stationary because the curves of the cam tracks 370a, 370b are configured so that they maintain a holding force to hold the slider 125a in a fixed position in the latch 385. This interrupted movement allows the slider to remain stationary while the trigger continues to rotate. Continued rotation of the trigger deploys the fastener, as will be explained with reference to FIG. 10.

[0076] The present invention will be better understood from the description of the components involved in deploying the fastener. FIG. 10A to FIG. 10C , these components are removed from the device for the purposes of this description. Fig. 10A , the trigger 119, the plunger lever 143 and the fastener delivery mechanism 140 are shown in their initial positions before the user operates the device. The plunger retainer 405 contacts the plunger lever pin 407 to maintain the plunger lever 143 in the shown position, for example during transportation and storage. The distal end of the plunger lever (referred to as the plunger driver 410) is operably connected to the plunger needle assembly 145 by a tab-in-slot arrangement or other slidable connection known in the art. Therefore, the restraining force provided by the plunger retainer 405 is shared with the plunger needle assembly 145, which maintains the internal components of the fastener delivery mechanism 140 in their initial positions. At this time, the plunger lifter 430 is not engaged. The action of the plunger lifter 430 is described below.

[0077] Fig. 10B The trigger 119 is shown after the user has squeezed it to move it to the first position. Fig. 10A The first position corresponds to Fig. 7A and Fig. 9B It is important to note that the plunger lever 143 and the plunger needle assembly 145 remain in their initial positions, as shown in FIG. Fig. 10A . This movement of the trigger 119 to the first position brings the plunger lever pin 407 into contact with the trigger platform 420, but until this point, the plunger lever 143 has not moved. This initial rotation to the first position allows the user to release the trigger to reposition the tissue as previously described without having to start deploying fasteners from the fastener delivery mechanism 140. The action of the plunger lifter 430 is described below.

[0078] Fig. 10C The following figure shows the state after the user fully squeezes the trigger 119 to deploy the fastener. Fig. 10B The position of the component corresponds to Figure 7C and Fig.9D . Movement of the trigger 119 to the position shown transfers force from the trigger station 420 to the plunger lever pin 407, thereby causing the plunger lever 143 to rotate about the plunger lever pivot 425. The rotational movement of the plunger lever transfers force from the plunger driver 410 to the plunger needle assembly 145, which acts on the internal components of the fastener delivery mechanism 140 (as described in Rogers). As a result of these actions, the insertion device 146 moves through the outlet 290, carrying a single fastener 50 for insertion into the tissue. After the fastener is deployed, the user releases pressure on the trigger and the spring 141 (as described in Rogers) is released. Figure 8 ) returns the trigger to Fig. 10AWhen the trigger is rotated about the trigger pivot hole 360 ​​to its initial position, the plunger lifter 430 acts on the plunger lever pin 407 to rotate the plunger lever 143 about the plunger lever pivot 425. This rotation of the plunger lever in the opposite direction of its previous action raises the plunger needle assembly 145 in accordance with the teachings in Rogers, thereby restoring the internal components of the fastener delivery mechanism and preparing for the next deployment.

[0079] Another embodiment of the present invention comprises a Fig.11 Additional components within the fastener delivery mechanism shown. Plunger needle assembly 545 replaces plunger needle assembly 145 to provide an interface with the spring driven delivery mechanism 500. The insertion device 146, other components of the fastener delivery mechanism, sliders 125a, 125b and tissue retainers 130a, 130b (not shown) remain the same as previously described. The additional components of the alternative embodiment allow the drive spring 505 to be compressed during the first stage of fastener deployment and then released during the second stage to accelerate the insertion device 146 carrying the fastener. Included in Fig.11 The components within the dashed line will refer to FIG. 12A to FIG. 12E Further description.

[0080] Fig. 12A The positions of the components of the spring driven delivery mechanism 500 are shown at the beginning of deployment before the user operates the device. The drive head 510 is held at the proximal limit of its travel by the drive spring 505, which applies a force to the retaining ring 512 to hold it against the top member 515 at the proximal end of the plunger needle assembly 545. The stops 507a, 507b are described in detail below.

[0081] Fig. 12B The components are shown moving distally relative to the stops 507a, 507b. The stops are molded features where the stop 507a is located in the fastener delivery mechanism 140 ( Figure 3 ) on the inner side of the left housing 147 of the delivery mechanism (see Figure 3 ), and the stopper 507b is on the inner side of the delivery mechanism right housing 149 (see Figure 3 ). When the drive head 510 moves distally in response to the user squeezing the trigger (not shown), the drive spring 505 of the spring-driven delivery mechanism 500 is preloaded with a small force between the retaining ring 512 and the plunger seat 517 and forces the plunger needle assembly 545 to move so that all components move distally relative to the stops 507a, 507b. Fig. 12B The position shown in allows the plunger needle assembly 545 to pick up one of the multiple fasteners in the fastener delivery mechanism, as described in Rogers. Fig. 12CAs further shown, sear-like barbed extensions on the plunger needle assembly (referred to herein as sears 520a, 520b) engage the stops 507a, 507b.

[0082] exist Fig. 12C 507a, 507b to temporarily stop the movement of the plunger needle assembly 545. As the user continues to squeeze the trigger, the drive head 510 of the spring-driven delivery mechanism 500 moves distally, thereby compressing the drive spring 505. The drive head 510 includes an inclined surface (shown here as a release cone 525) that interacts with the triggers 520a, 520b to disengage them from the stops 507a, 507b. The mechanism for releasing the trigger can be a conical surface or simply an inclined tab protruding from the drive head or other shapes known in the art that can interact with the triggers to bend them toward the middle and release them from the stops.

[0083] Fig.12D The following diagram shows the state of the latch 520a, 520b after it has disengaged from the stopper 507a, 507b. Fig. 12C The spring driven delivery mechanism 500 is a component of the invention. The triggers 520a, 520b have released the energy stored in the drive spring 505, and the plunger needle assembly 545 has accelerated distally. In this rapid motion, the plunger needle assembly acts on the insertion device 146 to drive the fastener into the tissue, such as Figure 7C When the fastener deployment is complete, the user releases pressure on the trigger and Fig.12E Pull the drive head proximally as shown.

[0084] Fig.12E Shown Fig.12D 500 as they move toward their starting position. The top member 515 engages the retaining ring 512, which transmits the proximal pulling force of the drive head 510 to move the plunger needle assembly 545 proximally. As the triggers 520a, 520b pass the stops 507a, 507b, the inclined surfaces cause the triggers to bend toward the middle to facilitate their movement past the stops. The final proximal movement of the drive head 510 returns all of the components of the spring-driven delivery mechanism to their original positions. Fig. 12A Starting position shown.

[0085] References throughout this specification to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. In addition, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0086] Although the present invention has been described with respect to one or more specific embodiments, it should be understood that the present invention disclosed herein can be modified or changed into other configurations.Except those shown and described herein, various modifications of the present invention and many other embodiments thereof will become apparent to those skilled in the art from the full content of this document (including reference to the science and patent documents cited herein).The subject matter of this article comprises important information, examples and guidance that can be applicable to the practice of the present invention in its various embodiments and its equivalents.Therefore, the present invention is not limited only to disclosed details.

[0087] The terms and expressions which have been employed herein have been used as terms of description and not of limitation, and in the use of such terms and expressions, there is no intention to exclude any equivalents of the features described and illustrated (or portions thereof), and it is recognized that various modifications are possible within the scope of the claims. Accordingly, the claims are intended to cover all such equivalents.

[0088] Incorporation by reference

[0089] Other documents, such as patents, patent applications, patent publications, journals, books, papers, web page content, have been referenced and cited throughout this disclosure. All of these documents are hereby incorporated herein by reference in their entirety for all purposes.

[0090] Equivalent

[0091] Various modifications of the invention and many other embodiments thereof, in addition to those shown and described herein, will become apparent to those skilled in the art from the entire contents of this document, including references to scientific and patent documents cited herein. The subject matter herein contains important information, examples, and guidance that can be applicable to the practice of the invention in its various embodiments and their equivalents.

Claims

1. A handheld surgical device for deploying a bioabsorbable fastener to close a wound or incision in tissue, the device comprising: a body including a handle element including a user-actuatable trigger and a barrel element including a distal end for positioning one or more fasteners relative to a wound or incision in tissue; a tissue clamping and folding assembly positioned adjacent the distal end of the barrel element and operably coupled to the trigger, wherein, when the distal end of the barrel element is positioned relative to the wound or incision and in response to actuation of the trigger by a user, the tissue clamping and folding assembly is configured to temporarily fasten and physically evert opposing edges of the wound or incision relative to the distal end of the barrel element in preparation for deployment of one or more of the plurality of fasteners; as well as A fastener delivery mechanism is operably coupled to the trigger and is configured to deploy one or more of a plurality of bioabsorbable fasteners from the distal end of the barrel member in response to actuation of the trigger by a user.

2. The device according to claim 1, wherein: Each fastener of the plurality of fasteners includes a first leg, a second leg, and a flexible bridging member connecting the first leg and the second leg.

3. The device according to claim 1, wherein: The fastener delivery mechanism is configured such that a given fastener extends outwardly and away from the distal-most end of the tissue clamping and folding assembly and the distal-most end of the barrel and subsequently penetrates the opposing edges of the wound or incision such that the fastener is fully deployed distally of the device and delivered beneath the surface of the tissue.

4. The device according to claim 1, wherein: The tissue clamping and folding assembly comprises: an introducer positioned at and extending from the distal end of the barrel element, the introducer comprising an elongated body configured to directly contact opposing edges of the wound or incision; and A pair of opposing tissue retainer elements are positioned at the distal end of the barrel element and on opposite sides of the elongated body of the introducer, each tissue retainer including a jaw member and a foot member, the jaw member and the foot member being configured to move cooperatively relative to the introducer in response to user actuation of the trigger.

5. The device according to claim 4, wherein: The elongated body of the introducer includes a pair of clamping rails extending along opposite sides of the elongated body.

6. The device according to claim 5, wherein: Each tissue retainer element includes a jaw element and a foot element, wherein, in response to the user's actuation of the trigger, the jaw element is adapted to clamp and fasten a portion of the corresponding edge of the wound or incision against the corresponding clamping guide, and the foot element is adapted to evert a portion of the corresponding edge of the wound or incision, thereby positioning the inner surface of the corresponding edge for subsequently receiving a portion of a fastener.

7. The device according to claim 6, wherein: The introducer includes an outlet through which at least a fastener passes in response to actuation of the trigger by a user during operation of the fastener delivery system.

8. The device according to claim 7, wherein: The leg elements of each tissue retainer element are adapted to expose the inner surfaces of the corresponding edges of the wound or incision relative to the outlet of the guide so that the deployment fasteners passing through the outlet can bilaterally engage the opposite edges of the wound or incision and thereby retain the edges together.

9. The device of claim 4, wherein: The trigger is coupled to the pair of tissue retainer elements and the fastener delivery mechanism by independent connections, thereby allowing sequential operation thereof.

10. The device of claim 9, wherein: A user actuating the trigger to an initial first position causes the jaw members of each tissue retainer element to rotate inwardly toward the introducer and further clamp and tighten a portion of a corresponding edge of the wound or incision against a corresponding side of the introducer; Actuation of the trigger by the user to a subsequent second position rotates the leg member of each tissue retainer element inwardly toward the introducer and further everts a portion of a corresponding edge of the wound or incision, thereby positioning an inner surface of the corresponding edge for subsequent receipt of a portion of a fastener; and Actuation of the trigger by the user to a subsequent third position operates the fastener delivery mechanism, thereby causing deployment of fasteners to bilaterally engage opposing edges of the wound or incision and thereby hold the edges together.

11. The device of claim 4, wherein: Each jaw element includes one or more sharp projections.

12. The device of claim 4, wherein: Each tissue retainer element is injection molded from a single material.

13. The device of claim 12, wherein: The jaw member and the foot member of each tissue retainer element are integrally formed with one another.

14. The device of claim 4, wherein: The jaw members and foot members of each tissue retainer element are formed of different materials and are assembled to cooperatively form a given tissue retainer element.

15. The device of claim 4, wherein: The jaw member and the foot member are movable relative to each other.

16. The device as described in claim 4 further includes a pair of slider elements, each slider element having a proximal end operably connected to the trigger and a distal end operably connected to a corresponding one of the pair of tissue retainer elements, so that actuation of the trigger causes movement of the pair of slider elements, which action in turn causes corresponding movement of the pair of relative tissue retainer elements.

17. The device of claim 4, wherein: The introducer includes a retraction finger positioned at one end of the elongated body and adapted to engage a first apex of the wound or incision to provide an opposing traction force applied at a second apex of the wound or incision.

18. The device of claim 1, wherein: The fastener delivery mechanism is configured to retain a plurality of fasteners and further includes one or more insertion needles configured to releasably engage and deploy each of the plurality of fasteners in a one-by-one manner in response to repeated actuation of the trigger by a user.

19. The device of claim 18, wherein: Each of the plurality of fasteners includes a first partially cannulated leg, a second partially cannulated leg, and a flexible bridging member connecting the first partially cannulated leg and the second partially cannulated leg, wherein the first partially cannulated leg and the second partially cannulated leg are each configured to allow a corresponding insertion needle to pass through a portion of the partially cannulated leg.

20. The device of claim 19, wherein: The trigger is operably connected to a plunger-needle assembly, which includes two insertion needles, which are parallel to each other and are configured to pass within a portion of the cannulated legs of corresponding portions of the fastener, and in response to the user's actuation of the trigger, the plunger-needle assembly causes the insertion needles to engage the fastener, thereby causing each leg of the fastener to penetrate the opposite edge of the wound or incision to insert the fastener, and in response to the user releasing the trigger, the plunger-needle assembly causes the insertion needles to be completely away from the fastener at the distal side of the device and below the tissue surface.

21. The apparatus of claim 18, wherein: Each of the plurality of fasteners includes a first cannulated leg, a second cannulated leg, and a flexible bridging member connecting the first cannulated leg and the second cannulated leg, wherein the first cannulated leg and the second cannulated leg are each configured to allow a corresponding insertion needle to pass therethrough, the insertion needle extending through the cannulated leg with a sharp end exposed distally.

22. The device of claim 21, wherein: The trigger is operably coupled to a plunger-needle assembly that includes two insertion needles that are parallel to each other and configured to pass through corresponding legs of the fastener.

23. The device of claim 22, wherein: In response to actuation of the trigger by the user, the plunger-needle assembly engages the insertion needle with the fastener and simultaneously penetrates the opposing edges of the wound or incision to insert the fastener, and in response to the user releasing the trigger, the plunger-needle assembly moves the insertion needle completely away from the fastener at the distal side of the device and below the tissue surface.

24. The device of claim 22, wherein: The fastener delivery mechanism is configured to receive and hold a magazine including a plurality of stacked fasteners, and the plunger-needle assembly is configured to releasably engage a forward-most fastener disposed in the fastener stack via the pair of insertion needles for subsequent deployment.

25. The device of claim 1, wherein: The fastener delivery mechanism includes a spring-driven delivery assembly, the spring-driven delivery assembly including: a plunger-needle assembly configured to releasably engage a forward-most fastener in a stack of fasteners disposed in the magazine; a drive head operatively coupled to the trigger and the plunger-needle assembly, wherein the drive head is configured to indirectly move the plunger-needle assembly by acting on a drive spring; a stop mechanism including a trigger configured to engage a corresponding stop and thereby prevent movement of the plunger-needle assembly when the drive head moves to a first drive head position; and A release element is adapted to disengage the trigger from the corresponding stop when the drive head is moved to the second drive head position.

26. The device of claim 25, wherein: A user actuating the trigger to an initial first position causes the drive head to move to the first drive head position and the plunger-needle assembly to engage the forward-most fastener; and The user actuates the trigger to a subsequent second position causing the drive spring to compress and causing the drive head to move to the second drive head position such that when the trigger is disengaged from the corresponding stop, the plunger-needle assembly is driven via the force applied from the compressed drive spring to deploy the fastener and deliver the fastener into tissue at a speed significantly faster than movement of the trigger.

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