Wound closure

Abstract

[0006] Surgical devices and systems for performing wound closure are provided. For example, a wound closure member includes an anchor, a spring member, and a body extending therebetween. The wound closure member is configured to apply an adjustable closure force to tissue to close the wound. A delivery instrument is further provided.

Description

Disclosed Content

[0001] [Cross - Reference to Related Applications] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 827,590, filed on April 1, 2019, entitled "Wound Closure", which is hereby incorporated by reference in its entirety.

[0002] [Field] Surgical devices, systems, and methods for closing wounds are provided.

[0003] [Background] Wound closure, e.g., closing a laceration or surgical incision in a patient's skin, is often accomplished by the use of sutures, surgical staples, or medical adhesives. Sutures are time - consuming to apply and can cause wound inversion, in which case necrotic tissue along the top surface of the skin is pushed inward toward the wound, which can delay the healing time and increase scarring. Sutures and staples can cause scarring and infection and can be painful during application. Medical adhesives generally may not be effective in permanently or substantially closing a wound and are often used as a dressing rather than as any type of permanent closure mechanism.

[0004] Accordingly, improved wound closure techniques are needed.

[0005] [Summary] Methods, devices, and systems for embedding wound closure tags for closing wounds are provided herein.

[0006] In one aspect, a system for closing a wound is provided, which includes at least one wound closure member having a first anchor, a second anchor, and a body extending between the first anchor and the second anchor and connecting the first anchor and the second anchor. The wound closure member is configured to provide an eversion closing force to the wound when the first anchor is positioned on a first side of the wound, the second anchor is positioned on a second side of the wound, and the body extends through the tissue of the wound. The system also has a curved delivery needle having a proximal opening end, a distal end terminating in a discharge port, and a channel extending between the proximal opening end and the discharge port. The channel is configured to slidably receive the first anchor. The system also has a push rod, which is slidably coupled to the curved delivery needle and configured to translate the first anchor of the wound closure member along the channel from the proximal opening end of the delivery needle to the discharge port.

[0007] The system can have many variations. For example, the first anchor can be a crossbar, and the second anchor can be a spring member selected from the group consisting of a plurality of flat or non-flat arms, a plurality of convex or concave arms, a hemispherical structure, a semi-circular panel extending towards the anchor, and a helix. The second anchor can also be configured to apply an abduction closing force that is adjustable based on the wound and the movement of the selected second anchor. In some embodiments, at least one wound closure member can include a plurality of wound closure members that are loosely connected to each other. Also, the plurality of wound closure members can be loosely connected by a spine. The system can also include a handle, which is connected to the proximal end of the delivery needle, configured to receive a push rod through the handle, and guide the push rod into the needle. The handle can have a trigger configured to slidably move the push rod. In one embodiment, the system can include a removable and replaceable cartridge configured to receive at least one wound closure member therein and removably fit onto the handle, and at least one wound closure member is translatable along the channel of the delivery needle from the cartridge during actuation of the push rod. The channel of the delivery needle can also have an upward slope that terminates at a discharge port. In another embodiment, the distal tip of the delivery needle can include a trocar tip.

[0008] In another aspect, a method of closing a wound within tissue is provided that includes passing a delivery needle that is curved to the tissue on the first and second sides of the wound. The method also includes passing a first anchor of a wound closure member through the needle channel from the first side of the wound to the second side such that the first anchor exits the delivery port at the distal end of the needle on the second side and engages the outer surface of the tissue on the second side. The method further includes retracting the delivery needle to release a second anchor of the wound closure member such that the second anchor engages the outer surface of the tissue on the first side of the wound. A body connected between the first anchor and the second anchor extends across the wound through the tissue. Further, the wound closure member applies an eversion closure force to the tissue, moving the first and second sides of the tissue toward each other, thereby closing the wound.

[0009] The method can have various different embodiments. For example, passing the first anchor can include advancing a push rod along the needle channel to advance the first anchor through the needle. The method also can include, prior to passing the first anchor, advancing the first anchor into the proximal end of the delivery needle channel such that the body extends through a slot formed in the side wall of the needle and the second anchor is positioned external to the needle. Passing the first anchor also can include actuating a trigger coupled to a handle on the proximal end of the delivery needle to advance the push rod along the needle channel from the proximal opening end to the delivery port, thereby passing through and releasing the first anchor. In one embodiment, the method also can include rotating a cartridge to align a third anchor of a second wound closure member with the needle channel. In some embodiments, the first anchor can be a crossbar and the second anchor can be a spring member selected from the group consisting of a plurality of flat or non-flat arms, convex or concave arms, a hemispherical structure, a semi-circular panel extending toward the anchor, and a helix. Further, retracting the delivery needle to release the second anchor can include the wound closure member applying an adjustable eversion closure force based on the movement of the wound and the selected second anchor.

[0010] The above embodiments will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings. The drawings are not intended to be drawn to scale. For clarity, not all components are labeled in all the drawings.

Brief Description of the Drawings

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[0012] 〔Detailed Description〕 Next, to provide an overall understanding of the structure, function, manufacture, and principles of use of the devices and methods disclosed in this specification, specific exemplary embodiments will be described. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and that the scope of the present invention is defined only by the claims. Features illustrated or described in connection with one exemplary embodiment can be combined with the features of other embodiments. Such changes and modifications are intended to be included within the scope of the present invention.

[0013] Furthermore, in the present disclosure, components named the same as those of the embodiments generally have similar characteristics, and thus, within a particular embodiment, each characteristic of each component named the same is not necessarily described in sufficient detail. Further, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used with such systems, devices, and methods. One of ordinary skill in the art will understand that for any geometric shape, the equivalents of such linear and circular dimensions can be readily determined. The size and shape of the systems and devices, as well as their components, can depend at least on the anatomical structure of the subject for which the systems and devices are used, the size and shape of the components used in the systems and devices, and the methods and procedures for which the systems and devices are used.

[0014] Various exemplary methods, devices, and systems are provided for closing a wound, such as a laceration or surgical incision, using one or more wound closure members. For example, a wound closure member is provided that has an anchor at its distal end, a spring member at its proximal end, and a body extending therebetween. The anchor can be configured to be delivered through tissue using a needle delivery device having a curved needle that penetrates tissue on the first and second sides of the wound. The anchor can engage tissue on the second side of the wound, and the body can follow behind the anchor during delivery so as to extend between the two sides of the wound. The spring member remains on the first side of the wound and can secure itself to the tissue on the first side. This can impart flexibility to the wound closure member, and an effective tensile or compressive force can be applied to the tissue on both sides of the wound to close the wound. As the tissue around the wound flexes and moves, the spring member can adjust the applied tensile force to maintain a generally corresponding closing force for closing the wound that increases or decreases based on the movement of the tissue. Further, the anchor and body are implanted using a curved needle, and thus, after implantation, the anchor and spring member are supported on the outer surface of the tissue, and the body extends generally semi-circularly and downwardly into the tissue to connect the anchor and spring member. This generally semi-circular path through the wound applies an upward force to the tissue along the wound, while the wound closure member always applies an adjustable closing force, thereby causing the wound to evert or the skin at the wound site to wrinkle upwardly. Eversion of the wound can promote faster healing, better blood flow, and less scarring along the wound, and the wound closure member can also avoid or reduce wound inversion, or strangulation of tissue at the wound site that results in poor closure and scarring. The wound closure member can also enable a more rapid closure process.

[0015] The wound closure member can be delivered to tissue using a delivery device. In one embodiment, the wound closure member can be delivered across the tissue of the wound using a needle having a curved distal portion, a channel extending at least partially therethrough, and a discharge port at the distal end. The needle can be passed through the first and second sides of the wound, and the anchor of the wound closure member can be passed through the channel of the needle from the first side of the wound to the second side and can exit from the discharge port at the distal end of the needle on the second side of the wound. The needle can assist in guiding the body of the wound closure member through the tissue such that the body extends between the first and second sides of the wound, and a spring member can be left on the first side of the wound by the needle to provide secure and flexible engagement on the first side, thereby closing the wound.

[0016] The needle can be incorporated into a variety of different delivery devices and various actuators can be used to pass the anchor of the wound closure member through the channel of the needle and out of the discharge port. A variety of delivery devices can also be used that incorporate one or more wound closure members configured to be manually loaded into the device or automatically deployed through various cartridge delivery systems described below.

[0017] Figure 1 shows one embodiment of a wound closure member in the form of a wound closure tag 100. The wound closure tag 100 has an anchor 110, an anchor or spring member 130, and a body 120 extending therebetween. The anchor 110 is shaped and sized to be delivered through a curved needle, as described below, across tissue from a first side 152 of a wound 150 to a second side 154 thereof, such that the anchor engages and is supported by an external tissue surface 156 on the second side 154 of the wound 150, as shown in FIG. 2. The body 120 follows behind the anchor 110 during delivery. Once implanted, the body extends between the first side 152 and the second side 154 of the wound 150, connecting the anchor 110 on the second side 154 to the spring member 130 on the first side 152 and forming a generally semi-circular path through the tissue. The spring member 130 is connected to the anchor 110 through the body 120 and is designed to remain on the first side 152 of the wound without passing through the tissue. Instead, the spring member engages the external tissue surface 158 on the first side 152 of the wound 150 after delivery and acts to secure the external tissue surface 158 on the first side 152. The spring member 130 is a flexible elastomer that bends and flexes as the tissue around the wound moves, such that the tag 100 can apply a closing force that is constantly adjusted as the patient moves or changes position by allowing the spring member 130 to bend or resist movement according to the amount the patient moves. Thus, the anchor 110, body 120, and spring member 130 operate together to apply an effective tensile closing force between the first side 152 and the second side 154 of the wound 150 without causing significant displacement of the tag 100 or significant tearing of the tissue. As indicated by the arrows in FIG. 3, the constantly adjusted tensile closing force of the tag 100 can be applied to the wound 150 along the semi-circular implantation path of the body 120 that extends beneath the surface of the wound. Thus, this applies a closing force that draws the first and second sides of the wound together, as indicated by the arrows in FIG. 3, and can also apply an upward or pulling force, thereby resulting in eversion of the wound and better healing results.

[0018] In the embodiment shown in FIG. 1, the wound closure tag 100 has an anchor 110 in the form of a crossbar, a body 120 in the form of an elongated shaft or strand, and a spring member 130 in the form of a crossbar similar to the anchor 110, which substantially represents a second anchor. Thus, the anchor and the spring member can represent similar components, and as will be described below, various other second anchors or spring members are possible. The body 120 extends vertically between the anchor 110 and the spring member 130. The wound closure tag 100 is generally in the shape of an "I", but as will be described below, various different shapes and orientations are possible for the spring member and / or the anchor. The tag 100 can be sized and shaped based on the intended surgical site to create different amounts of tensile closure force applied to the wound. For example, the tensile closure force can be varied by using different lengths for the body 120 and / or by using different designs or different flexibilities for the spring member 130. The illustrated body 120 has a constant length, but some bodies can have a flexible or adjustable length that can be changed during use to allow for a customized closure length and / or a customized tensile closure force.

[0019] The wound closure tag 100 can be composed of various materials such as plastic, metal, medical elastomer, polymer, hydrogel, nitinol, biological tissue, absorbable materials, non-absorbable materials, etc. Various parts of the tag 100, such as the spring member 130 as described below, can be composed of various materials. The tag 100 can have various dimensions based on the desired use of the tag 100. However, the body 120 can have a length of about 4.0 to 12.0 mm, more preferably about 6.0 to 9.0 mm, and a diameter of about 0.05 to 0.40 mm, more preferably about 0.10 to 0.35 mm. Further, the anchor 110 can have a length of about 3.0 mm to 7.0 mm, more preferably about 4.0 mm to 6.0 mm, and a diameter of about 0.2 mm to 0.6 mm, more preferably about 0.3 mm to 0.5 mm. The illustrated spring member 130 in FIG. 1 can have dimensions similar to those of the anchor 100, but the spring member can have various different configurations in different embodiments as described below. The wound closure tag 100 can be placed in the patient's skin at various depths and distances from the wound 150. For example, the anchor 110 and the spring member 130 can extend through the patient's skin and be positioned on both sides thereof about 3 to 4 mm away from the wound 150.

[0020] As described above, depending on the desired wound closure application and the desired tensile closure force, many different configurations of the spring member can be used. FIG. 4 shows another embodiment of a wound closure tag 200 similar to tag 100. The wound closure tag 200 has an anchor 210 in the form of a crossbar, a body 220 that is an elongated shaft or strand, and a spring member 230. The spring member 230 is in the same plane as the anchor 210 and is in the shape of a semi-circle that curves towards the anchor 210. The spring member 230 has two arms 232a, 232b, and the arms each extend radially outward from the body 220 to form the semi-circular shape of the spring member 230. The end of each arm has a sphere 234 that can be supported on the outer tissue surface on the first side of the wound during deployment, and the arms 232a, 232b extend over the outer tissue surface and can be compressed towards the outer tissue surface when a tensile closure force is required to close the wound. Thus, the curved shape of the arms 232a, 232b that form the spring member 230 can provide additional bending or tensile resistance to the movement of the tag 200 when the tag 200 extends across the first and second sides of the wound, which can also increase the tensile closure force applied to the tissue on both sides of the wound to more securely close the wound.

[0021] FIG. 5 shows a wound closure tag 250 similar to tag 200, comprising an anchor 260, a spring member 280, and a body 270 extending therebetween. The spring member 280 is a semi-circular member similar to the spring member 230, but is in a plane perpendicular to the plane of the anchor rather than in the same plane as the anchor 260.

[0022] The spring members 230, 280 each have two arms, but various numbers of arms can be used in many different configurations. For example, FIG. 6 shows another embodiment of a wound closure tag 300 similar to tags 200 and 250. The wound closure tag 300 has an anchor 310, a spring member 330, and a body 320 extending therebetween. In this embodiment, the spring member 330 has three arms 332a, 332b, 332c, each arm having a first end engaging the body and a second end having a sphere 334 positioned proximate the anchor 310. The sphere 334 can be supported on the outer tissue surface on the first side of the wound during deployment, and the hemispherical shape of the spring member 330 can provide additional bending or tensile resistance to the movement of the tag 300, which can also generate additional tensile closing forces applied to both sides of the wound.

[0023] FIG. 7 shows a wound closure tag 350 similar to tag 300, comprising an anchor 360, a spring member 380, and a body 370 extending therebetween. The spring member 380 is a hemispherical member similar to the spring member 330, but has four arms 382a, 382b, 382c, 382d that curve toward the anchor 360 and define a generally hemispherical shape. Two of the arms 382b, 382d are in the same plane as the anchor 360, and the other two arms 382a, 382c are in a plane perpendicular to the plane of the anchor 360. However, various other alignments of the arms are possible, such as aligning the arms with the anchor at various non-right angles.

[0024] Figure 8 shows another embodiment of a wound closure tag 400 similar to tags 300 and 350. The wound closure tag 400 has an anchor 410, a spring member 430, and a body 420 extending therebetween. The spring member 430 has four arms 432a, 432b, 432c, 432d, each of which has a first end engaging the body 420 and a second end or distal end engaging a ring 440. The ring 440 extends co - radially around the body 420 and engages all of the arms 432a, 432b, 432c, 432d such that the ring 440 and the arms 432a, 432b, 432c, 432d define a hemispherical shape that surrounds a portion of the body 420 within the defined hemisphere. When the tag 400 is delivered from a first side 452 to a second side 454 of a wound 450, the ring 440 contacts the outer tissue surface 458 on the first side 452 and provides a large and stable contact surface for the spring member 430 against the outer tissue surface 458, as shown in FIGS. 9 and 10. The arms 432a, 432b, 432c, 432d can bend and flex to help the tag 400 apply a tensile closing force between the two sides 452, 454 of the wound 450 by applying an upward tensile force on the body 420 when in a compressed state during initial delivery. For example, as shown in FIG. 9, the arms 432a, 432b, 432c, 432d can be compressed toward the outer tissue surface 458 during initial delivery when the tag 400 acts to close the wound 450. In this way, the hemispherical shape of the spring member 430 can be flattened and distorted toward the outer tissue surface 458 during delivery such that the radius R1 of the hemispherical shape is smaller than when the spring member 430 is in a rest or pre - deployed state. When the wound 150 is closed, the arms 432a, 432b, 432c, 432d can return to a less distorted hemispherical orientation with less tension, as shown in FIG. 10, since the tensile closing force required to help the tag 400 pull the two sides 452, 454 of the wound together is reduced, and the radius R1 of the hemispherical shape can be increased to a value more equivalent to the radius when the spring member 430 is in a rest state.

[0025] Figures 11A - 11C show another embodiment of a wound closure tag 500 similar to tags 200 and 250. The wound closure tag 500 has an anchor 510, a spring member 530, and a body 520 extending therebetween. The spring member 530 is in the shape of a semi - circular plate extending towards the anchor 510. It has two plate arms or sides 532a, 532b, each having one end engaged with the body 520 and the opposite end extending towards the anchor 510. The arms 532a, 532b extend away from the body 520 to form the wide semi - circular plate shape of the spring member 530, generally forming a partial cylindrical shape, and the body 520 extends from the inner surface within the semi - circular curve of the partial cylinder. Each of the arms 532a, 532b terminates in a cylindrical bar 534 that extends along the edge of each arm 532a, 532b, positioned near the anchor 510. The plate arms 532a, 532b extend on the same plane away from the body 520 and towards the anchor 510. However, various other alignments of the plate arms 532a, 532b are possible, for example, the arms 532a, 532b can be perpendicular to the anchor 510 and / or the arms 532a, 532b can be aligned at various non - right - angle angles to the anchor. When the tag 500 is delivered to a wound and extends from the first side to the second side of the wound, the cylindrical bar 534, similar to the ring 440 of tag 400, contacts the outer tissue surface on the first side of the wound, providing a stable contact surface between the spring member 530 and the tissue. When the tag 500 applies a tensile closing force to the wound, the arms 532a, 532b can bend and curve, similar to the arms 432a, 432b, 432c, 432d, to help apply a greater force. Since the spring member 530 has wide arms 532a, 532b, the force applied is greater than the force applied by thin arms such as those on tag 200. In other embodiments, the force applied by the spring member 530 can be adjusted by changing the thickness of the plate arms 532a, 532b and / or by changing the manufacturing material and thus the modulus of elasticity of the spring member 530.In yet other embodiments, the force of the spring member 530 can be adjusted by changing the outer shape of the spring member 530, for example, by forming the spring member 530 into a semi-elliptical or flexible flat plate, thereby changing the depth and adjustable length of the body 520 and / or the spring member 530 between the cylindrical body 534 and the anchor 510.

[0026] FIG. 12 shows another embodiment of a wound closure tag 600 similar to tags 200 and 250. The wound closure tag 600 has an anchor 610, a spring member 630, and a body 620 extending therebetween. The spring member 630 is generally shaped like a heart or a shovel, forms a tip 634 at the end opposite the anchor 610, and has two lobes 632a, 632b that each extend toward the anchor 610. However, the end of the spring member 630 opposite the anchor 610 may be rounded. The ends of the lobes 632a, 632b closest to the anchor 510 are supported on the outer tissue surface on the first side of the wound during deployment, and the lobes 632a, 632b can each provide additional bending or tensile closure force to the anchor 600.

[0027] Many other designs can also be used for the spring member. For example, FIGS. 13A - 13I and FIGS. 14A - 14I show various additional wound closure tags having various different spring members. FIGS. 13A - 13I show each wound closure tag when viewed from the corresponding spring member towards the corresponding anchor, and FIGS. 14A - 14I show each wound closure tag when viewed from the side. For example, FIGS. 13A and 14A show a wound closure tag 700, which includes an anchor 702, a body 704, and a spring member 706 shaped like a coil spring or helix that is wound around an end of the body 704 opposite the anchor 702 and bulges along the central portion. FIGS. 13B and 14B show a wound closure tag 710, which includes an anchor 712, a body 714, and a spring member 716 shaped like a conical coil or helix with a conical tip facing away from the anchor 712 and a wider base facing the anchor 712. FIGS. 13C and 14C show a wound closure tag 720, which includes an anchor 722, a body 724, and a spring member 726 shaped like a conical wireframe with a helical conical tip facing away from the anchor 722 and a wider base facing the anchor 722. FIGS. 13D and 14D show a wound closure tag 730, which includes an anchor 732, a body 734, and a spring member 736 shaped like a cone with a solid panel on the side and a conical tip facing away from the anchor 732, and a wider base facing the anchor 732. FIGS. 13E and 14E show a wound closure tag 740, which includes an anchor 742, a body 744, and a spring member 746 having an arm similar to tag 350 but angularly offset from the anchor 742. FIGS. 13F and 14F show a wound closure tag 750, which includes an anchor 752, a body 754, and a spring member 756 that is a cylinder made of various materials such as hydrogel, elastomer, thermoplastic, partially resorbable material, foam, nitinol, various polymers, etc. The spring member 756 can also be made expandable during use.Figures 13G and 14G show a wound closure tag 760, which comprises an anchor 762, a body 764, and a spring member 766 made of an amorphous or expandable material such as biological tissue, hydrogel, alginate, etc. Figures 13H and 14H show a wound closure tag 770, which comprises an anchor 772, a body 774, and a spring member 776 including a plurality of disordered arms protruding from an end of the body 774 opposite to the anchor 772, which gives the appearance of a mop or a feather duster. Figures 13I and 14I show a wound closure tag 780, which comprises an anchor 782, a body 784, and a spring member 786 in the shape of a cylinder arranged perpendicular to the body 784. The body 784 can translate in a slidable manner perpendicular to the center line of the spring member 786. The cylinder of the spring member 786 can be folded, and the outer or inner surface of the spring member 786 can be attached to the body 784 away from the anchor 782. All of these spring members can be folded during deployment and have, for example, an expandable foam, frill, a shape memory material such as nitinol, etc., which are held in a tensioned state compressed until deployment, and they can be lyophilized to enable deployment before starting to expand, for example, a cryogel that starts to expand once in contact with heat and / or moisture.

[0028] The anchor can also be foldable during deployment and expandable once delivered. For example, Figures 15A and 15B show a wound closure tag 790, which comprises an anchor 792, a body 794, and a spring member 796 with arms similar to the tag 200. A lyophilized hydrogel 792a is attached to the anchor 792. During deployment as shown in Figure 15A, the anchor 792 is in a non-expanded state because there is not enough time for the hydrogel 792a to react to heat and / or moisture. However, after deployment, as shown in Figure 15B, the anchor 792 expands as the hydrogel 792a interacts with the heat and / or moisture in the body.

[0029] The various anchors on the above-described wound closure tag are sized and shaped to be deployed through a delivery needle. The delivery needle passes through the first and second sides of the wound and, while still piercing both sides of the wound, passes the anchor of the wound closure tag therethrough such that the anchor moves through the first and second sides and exits the tissue on the second side, enabling it to secure itself there. The needle also assists in guiding the body of the wound closure tag during placement of the anchor, such that the body can extend through the first and second sides of the wound between the spring member and the anchor of the wound closure tag located on the first side of the wound.

[0030] Figures 16A - 16C illustrate an embodiment of a delivery needle 800, which has a curved distal portion 800d, a channel 802 that extends at least partially along the delivery needle, a discharge port 804 positioned at the distal end of the channel 802, a sharp distal tip 806, and an open proximal end 808. The channel 802 is sized to receive anchors of various wound closure tags within the channel such that an anchor can slide along the channel 802 during delivery, and has a slot 803 that forms an opening or passage from the channel 802 external to the needle 800, along which the body can slide during delivery. The discharge port 804 at the distal end of the channel 802 enables the anchor to be released from the delivery device. In some embodiments, the channel 802 has an upward inclination 802a at its distal end that approaches the discharge port 804, through which the anchor can exit, and the black bar indicates the general path of the bottom of the channel 802 including the upward inclination 802a. The distal tip 806 can be formed from various types of needle tips such as a cutting and / or trocar tip needle having a wide solid through - side. In FIG. 16C, an exemplary loading process is shown using a wound closure tag 100 with internal interactions indicated by dashed lines, although any wound closure tag can be used. The needle 800 can load an anchor into the needle by passing the anchor 110 through the discharge port 804, with the body 120 extending from the anchor 110 through the slot 803, a spring member 130 connected to the body 120 and positioned external to the needle 800, and sliding the anchor 110 proximally along the channel 802. The open proximal end 808 of the needle 800 can receive a flexible push rod 810 therein, such that during delivery of the anchor to a wound site, the push rod can push the anchor distally towards the distal tip 806 and the discharge port 804. Since the flexible push rod 810 extends through the channel 802, the needle 800 can push the anchor 110 out of the discharge port 804 when the anchor 110 slides along the inclination 802a of the channel 802.

[0031] The needle 800 can be made from a variety of materials such as medical grade metals, e.g., steel, various rigid plastics or polymers, etc., and various push rods can be used in the form of an elongated shaft, and similarly, can be made from a variety of materials such as Inconel, spring steel, polymers, nitinol, polymer braided and woven steel composites, thermoplastics, elastomers, etc.

[0032] In use, when the anchor 110 is loaded proximally within the needle 800, the needle can pass through the tissue at the wound. As shown in FIG. 17A, a surgeon can use various tools such as forceps 914 to grasp the first side 902 of the wound 900 within the patient's tissue 910. Then, the distal tip 806 of the needle 800 can pass through the tissue on the first side 902 of the wound 900. The needle 800 shown in FIGS. 17A - 17C is disposed on the handle 916, but the needle 800 can be disposed on or incorporated into various devices as described below. Then, as shown in FIG. 17B, the second side 904 of the wound 900 can be grasped, and as shown in FIG. 17C, the distal tip 806 of the needle 800 can pass through the second side. Thus, the needle 800 can extend across the wound 900 with the proximal side of the needle 800 on the first side 902 of the wound 900 and the distal side of the needle 800 on the second side 904 of the wound 900. The distal tip 806 can extend out of the second side 904, and thus, the channel 802 can form a passageway or path through the wound 900. Since the distal portion of the needle is curved, the path is semi - circular.

[0033] The proximal end 808 of the opening of the needle 800 can receive the flexible push rod 810 therein, and the anchor 110 can be pushed distally toward the distal tip 806 and the release port 804 as the push rod 810 advances distally. The push rod 810 can be manually inserted and advanced by a surgeon or can be actuated through various mechanisms described below. When the flexible push rod 810 extends through the channel 802, the needle 800 can push the anchor out of the release port 804 as the anchor 110 slides along the incline 802a of the channel 802, thus positioning the anchor 110 on the second side 904 of the wound 900 with the body 120 extending through both sides of the wound 900. The spring member 130 remains on the first side 902 as shown in FIG. 17D. In various other embodiments, the needle can pass through both sides of the wound simultaneously and / or forceps or other grasping instruments may not be required depending on the level of comfort of the surgeon and / or how severe or open the wound is.

[0034] The mechanism for loading one or more anchors into the needle and actuating the push rod to pass the anchor therethrough can vary as described below. However, in the embodiments below, a basic process is used of passing the needle through each side of the wound and advancing the push rod distally along the channel of the needle to deliver the anchor of the wound closure tag across the wound through the channel, providing for the delivery of the anchor and the placement of the wound closure tag across the wound.

[0035] The needle 800 is manually loaded through the discharge port 804, although different loading mechanisms are possible. For example, FIGS. 18A and 18B illustrate an embodiment of a delivery needle 850 that can be loaded from the proximal end and enable the delivery of multiple anchors without interacting with the distal end of the needle. Proximal loading can enable easier loading, including the automatic loading described below, and avoid the hassle and accidental user needle sticks caused by loading through the discharge port. The needle 850 is a curved needle similar to the needle 800 and includes a channel 852 along which a slot 853 extends, a discharge port 854 positioned at the distal end of the channel 852, a sharp distal tip 856, and an open proximal end 858. The channel 852 extends from the open proximal end 858 to the discharge port 854. Thus, the needle 850 can be loaded from the proximal open end 858.

[0036] The exemplary loading process is shown using the wound closure tag 500 in FIG. 18A, although any wound closure tag can be used. As shown, the needle 850 can receive the anchor 510 into the channel 852 through the proximal opening end 858, and the body 520 extends through the channel 852 and slides along the channel with the movement of the anchor 510. The spring member 530 extends from the body 510 and remains outside the needle. After the distal tip 856 has passed through the two sides of the wound, the proximal opening end 858 of the needle 850 can receive a flexible push rod 860 that extends distally along the channel 852 and pushes the anchor 510 distally through the channel 852, as shown in FIG. 18B by the dashed line representing internal engagement. The needle 850 can push the anchor 510 out of the release port 854. Similar to the channel 802 of the needle 800, the channel 852 provides a path along which the anchor 510 can move to move the anchor from the first side of the wound to the second side, the body 520 extends through the slot 853 and follows behind the anchor 510, and the spring member 530 remains on the first side. The anchor 510 is described as being loaded into the proximal opening end 858 of the needle 850. However, the anchor 510 can be loaded through the release port 854 as needed, similar to the needle 800.

[0037] As described above, the needle 850 can be manually loaded by a surgeon inserting an anchor into the needle 850, or automatically loaded by using various delivery devices as described below. FIGS. 19A-19J illustrate one embodiment of a delivery device 1000 for delivering wound closure tags. The delivery device 1000 can enable rapid automatic loading of one or more wound closure tags during use, allowing the surgeon to rapidly deliver wound closure tags to close a wound. The delivery device can also have a removable and replaceable wound closure tag cartridge, which enables the surgeon to deliver multiple wound closure tags during a single procedure and / or easily use various types of wound closure tags during a single procedure by simply replacing the cartridge. Generally, the device 1000 includes a housing 1002, a curved needle 1010, an actuating mechanism including a trigger 1020, and a cartridge 1040.

[0038] The housing 1002 is a generally rectangular object that slopes or curves downward from the proximal end 1002p toward the distal end 1002d to enhance visibility when operating the device 1000. The housing 1002 has a cartridge opening 1004 in the form of a cavity configured to removably receive a cartridge 1040 therein and hold the cartridge 1040 in a rotatable engagement through various mechanisms such as a combination of clips, protrusions, and detents. The housing 1002 also has a body slot 1006 that extends between the channel 1018 of the needle 1010 and the cartridge 1040 to allow the body and spring member of the wound closure tag to exit the cartridge 1040 and advance along the needle 1010 during delivery of the anchor as described below. In FIGS. 19A - 19J, the device 1000 is used with a wound closure tag 500, but any wound closure tag can be used. The housing 1002 can be designed and shaped to be held in a similar manner to a needle driver, such as in an external orientation as shown in FIG. 19H, a neutral orientation as shown in FIG. 19I, or an internal orientation as shown in FIG. 19J, to assist the surgeon in quickly understanding how to use the device.

[0039] The needle 1010 is similar to the needle 850 described above and extends distally from the distal end 1002d of the housing 1002. The needle has a sharp distal tip 1012, a discharge port 1014, an opening proximal end 1016, and a channel 1018 that extends between these two. The needle 1010 can be advanced through the first and second sides of the wound and deliver the anchor 510 of the wound closure tag 500 across the wound. The anchor 510 can be loaded from the opening proximal end 1016 of the needle 1010 that is aligned with the cartridge 1040.

[0040] Cartridge 1040 houses a plurality of wound closure tags 500 therein. Cartridge 1040 can automatically load wound closure tags 500 onto needle 1010 when device 1000 is actuated during use and can be rotated to align another wound closure tag 500 after delivery of the first wound closure tag. The illustrated cartridge 1040 is a circular object that can be received within cartridge opening 1004 and rotated relative to the cartridge opening, similar to the rotatable bullet cylinder of a revolver pistol, although other configurations such as top-loading or side-loading cartridges are possible as discussed below. Cartridge 1040 has a distal side 1040d, a proximal side 1040p, and a plurality of tag openings 1042 in the form of cavities extending from distal side 1040d to proximal side 1040p. Each tag opening 1042 is sized and shaped to removably receive a selected wound closure tag such as the illustrated tag 500. Each tag opening 1042 is offset from and adjacent to longitudinal central axis A1 of cartridge 1040 and receives an anchor 510 within an adjacent anchor cavity 1042a. Each anchor cavity 1042a is positioned to align with the opening proximal end 1016 of needle 1010 when cartridge 1040 is rotated. Each opening 1042 also has a body cavity 1042b that extends radially outward from anchor cavity 1042a away from longitudinal central axis A1 of cartridge 1040 to receive body 520 of tag 500. Body cavity 1042b terminates at spring member cavity 1042c that is radially farthest from longitudinal central axis A1 of cartridge 1040, which receives spring member 530 therein such that cartridge 1040 is configured to receive a plurality of tags 500 that fan out from longitudinal central axis A1.The cartridge 1040 can align one of the anchor cavities 1042a with the proximal end 1016 of the opening of the needle 1010, and can receive the push rod 1030 through the anchor cavity 1042a from the proximal side surface 1040p such that any anchor 510 contained therein is pushed distally into the proximal end 1016 of the opening of the needle 1010, thus loading the anchor 510 into the needle 1010 and moving the associated wound closure tag 500 distally from the cartridge 1040 perpendicular to the longitudinal central axis A1. The anchor cavity 1042a can receive the push rod 1030 through the anchor cavity when the tag 500 is delivered to the wound, as described below. Upon successful delivery, the push rod 1030 is retracted proximally from the anchor cavity 1042a, and the cartridge 1040 is rotated about its longitudinal central axis A1 to align the next anchor cavity 1042a with the proximal end 1016 of the opening of the needle 1010 and allow for optional delivery of another tag 500. In some embodiments, the cartridge 1040 can be disposable after use.

[0041] The push rod 1030 can be part of an actuating mechanism used to deliver one or more wound closure tags 500 across a wound along the needle 1010 from the cartridge 1040. The illustrated actuating mechanism includes a trigger 1020, a lever 1022, a first gear 1024 and a second gear 1026, a push rod 1030, a rack 1032, and an alignment member 1034. The trigger 1020 is biased to extend away from the housing 1002 and is pivotally connected to the housing at a pivot point 1020p. The trigger 1020 is connected to the lever 1022 by a slot 1020a formed in the trigger, which allows the lever 1022 to slide along the slot when the trigger 1020 is actuated by pivoting the trigger 1020 towards the housing 1002. The trigger 1020 has a stop member 1020b that contacts the housing 1002 when fully actuated to stop the movement of the trigger 1020. The lever 1022 is pivotally connected to the first gear 1024 and the second gear 1026 on the side opposite the trigger 1020 at a pivot point 1022p. The first gear 1024 and the second gear 1026 are connected to the housing 1002 at pivot points 1024p, 1026p. When the trigger 1020 is actuated, the lever 1022 moves slightly proximally towards the housing 1002, causing the lever 1022 to rotate the gears 1024, 1026 about the pivot points 1024p, 1026p, thereby rotating the gears 1024, 1026 towards the distal end 1002d of the housing 1002. The gears 1024, 1026 have teeth extending therefrom, and the teeth engage corresponding openings in the rack 1032, which is an elongated member that extends within a slot from the proximal end 1002p to the distal end 1002d of the housing 1002 and is slidable distally therein. The rack 1032 has a push rod 1030 fixed to and extending from its distal end and an alignment member 1034 at its distal end. When the gears 1024, 1026 rotate towards the distal end 1002d of the housing 1002, the teeth of the gears push the rack 1032 distally, which in turn pushes the push rod 1030 distally.When the cartridge 1040 is aligned with the push rod 1030 and the needle 1010, the push rod 1030 passes through the aligned anchor cavity 1042a of the cartridge 1040, through the opening proximal end 1016 of the needle 1010, and enters the channel 1018. When the trigger 1020 is released, the process is reversed, moving the lever 1022 away from the housing 1002 and causing proximal rotation of the gears 1024, 1026. During proximal rotation, the teeth of the gears 1024, 1026 push the rack 1032 proximally within the housing 1002, thereby moving the push rod 1030 proximally and retracting it proximally from the needle 1010 and the cartridge 1040. The alignment member 1034 is configured to slide distally and proximally within the housing 1002 with the distal and proximal movement of the rack 1032, keeping the rack 1032 and the push rod 1030 aligned during movement and being located within the alignment slot 1008 in the housing 1002 that terminates at the distal point of full actuation to prevent excessive actuation. The push rod 1030 may also be a single flexible structure or, as shown in FIG. 19D, may have a flexible portion 1030a that slides movably through a friction reduction guide 1030b. Further, one or more springs can be provided within the housing to provide tactile feedback during actuation and / or slow down the movement of the mechanism within the housing. For example, a spring can be provided on the lever 1022 to provide tactile feedback and bias the device 1000 to an inoperative state. A spring can also be provided around the alignment member 1034 to slow down the return of the rack 1032 after actuation.

[0042] Accordingly, during use, the surgeon can load the cartridge 1040 into the housing 1002 and align the cartridge 1040 with the needle 1010. The needle 1010 can pass through two sides of the wound such that the needle 1010 extends across the wound and the distal tip 1012 protrudes from the second side. The trigger 1020 can be actuated to cause rotation of the gears 1024, 1026 and subsequent distal movement of the rack 1032 and the push rod 1030. The push rod 1030 extends distally through the cartridge 1040 and can move the anchor 510 of the tag 500 into the channel 1018 through the proximal end 1016 of the opening of the needle 1010. The push rod 1030 can continue to advance distally through the channel 1018 until the anchor 510 of the tag 500 exits the release port 1014 and is delivered to the second side of the wound, whereby the tag 500 is delivered in the same manner as the process described above. During movement of the anchor 510, the body 520 and the spring member 530 advance distally from the cartridge 1040. The body 520 follows behind the anchor 510 along the channel 1018 of the needle 1010 through the body slot 1006 of the housing 1002. When the anchor 510 passes through the channel 1018, exits the release port 1014 and is disposed on the second side of the wound, the body 520 follows behind the anchor 510 through the wound, extends from the second side to the first side, and the spring member 530 is supported on the first side of the wound after being separated from the cartridge 1040.

[0043] Cartridge 1040 is configured to rotate automatically and aligns automatically with the needle 1010. However, in various other embodiments, the cartridge can be rotated and / or aligned manually, and various mechanisms can be incorporated into the cartridge, housing 1002, or some combination of the two to assist with automatic and / or manual alignment and rotation. For example, markings on the cartridge and / or housing, ratchet mechanisms, pairs of springs and pins, protrusions, detents, notches, holes, etc. can all be used. For example, FIG. 19K shows a cartridge 2040 similar to cartridge 1040, which has a plurality of angled notches 2042 along its proximal face 2040p. The angled notches 2042 receive pins 2044 disposed within a housing (not shown) similar to housing 1002, and the pins 2044 are biased by springs 2046 to engage the cartridge 2040. The angled notches 2042 are angled such that as the cartridge 2040 rotates counterclockwise (as viewed when facing the proximal face 2040p), the pin 2044 travels along the proximal face 2040p until it pops out of engagement with the first notch 2042 and reaches the second notch 2042, at which point the pin 2044 engages the second notch 2042. This operation ensures alignment of the cartridge 2040 and can also provide an audible click or thump sound upon alignment. The pin 2044 also resists clockwise rotation, ensuring that the surgeon can continue to rotate the cartridge into the aligned position loaded with the wound closure tags until all wound closure tags have been delivered. However, other engagements are possible, and mechanisms can be incorporated into the device 1000 to automatically advance the cartridge 1040. For example, one or more detents can be attached to the trigger 10220, lever 1022, gears 1024, 1026, etc. to engage a ratchet and rotate the cartridge to the next undelivered tag 500, and another detent can be placed in a small depression on the cartridge 1040 to stop the cartridge 1040 at a specific position, aligning it with the needle 1010 and push rod 1030, which is similar to the rotatable bullet cylinder of a revolver pistol.

[0044] Delivery device 10000 has been described above in conjunction with the rotary cartridge 1040, although various different delivery devices and loading mechanisms are possible, such as side or top loading, and loading parallel to the push rod. FIGS. 20A and 20B are similar to delivery device 1000, but show another embodiment of delivery device 3000 having a top-loading wound closure tag. Device 3000 includes a housing 3002, a curved needle 3010, an actuating mechanism with a trigger 3020, and a receiving port 3040 for seating a plurality of wound closure tags. Housing 3002 is in the shape of a pistol with a pistol grip 3002a, from which needle 3010 projects distally. Housing 3002 has a body slot 3006 (similar to body slot 1006) that passes through its side, and the body of the wound closure tag passes along the body slot while the corresponding anchor is being delivered through needle 3010. FIGS. 20A and 20B show a plurality of wound closure tags 100, although any wound closure tag can be used. Needle 3010 is configured similarly to needle 1010 and is loaded through a proximal opening end (not shown) within housing 3002, and the needle has a channel aligned with receiving port 3040. Trigger 3020 of the actuating mechanism is similar to trigger 1020 and engages pistol grip 3002a of housing 3002, and actuation of trigger 3020 by pivoting trigger 3020 towards pistol grip 3002a can be achieved while holding device 3000 by pistol grip 3002a. Similar to the actuating mechanism of device 1000, actuation of trigger 3020 causes rotation of one or more gears (not shown) within housing 3002, drives a rack (not shown) distally, and advances a push rod (not shown) distally along a slot aligned with the bottom of receiving port 3040 and the proximal opening end of needle 3010.

[0045] The receiving port 3040 is shaped to receive a plurality of wound closure tags 100 arranged in series along all of the tag spine 3045 such that each anchor 110 of each tag 100 is vulnerably connected to the tag spine 3045. The bottom of the receiving port within the housing 3002 has its distal end aligned with the proximal open end of the needle 3010 and its proximal end aligned with the push rod. Thus, this serves as an alignment surface for receiving the next anchor 110 to be delivered. The receiving port 3040 has an anchor receiving channel 3040a which receives a plurality of anchors 110 connected vertically to the spine 3045 through the upper portion of the housing 3002, and all of the anchors 110 are aligned such that each anchor is loaded distally into the proximal open end of the needle 3010 when it reaches the bottom of the receiving port 3040. Also, the receiving port 3040 has a body channel 3040b which extends between the anchor receiving channel 3040a and the body slot 1006 on the housing 3002, and a plurality of bodies 120 connected to the corresponding plurality of anchors 110 loaded into the device 3000 can move vertically downward along the body channel 3040b as the anchors 110 and the spine 3045 move downward, and then each body 120 can move distally along the body slot 3006 together with the corresponding anchor 110 when delivered through the needle 3010. A corresponding plurality of spring members 130 extend along the side of the housing 3002 and are not received within the housing. The spine channel 3040c is formed vertically adjacent to the anchor receiving channel 3040a within the housing and can optionally extend through its entirety. The spine channel 3040c receives the spine 3045 along it and extends below the bottom of the anchor receiving channel 3040a. Thus, the bottom of the spine 3045 which had accommodated the already delivered anchors 110 has room to continue moving downward, and the next anchor 110 to be delivered can maintain an accurately aligned state with the push rod and the needle 3010 on the bottom of the receiving port 3040 without interference from the spine 3045.

[0046] In use, the spine 3045 with a plurality of wound closure tags 100 attached thereto in a fragile manner can be loaded into the receiving port 3040 with the anchor 110 vertically aligned within the anchor channel 3040a and the body 120 vertically aligned within the body channel 3040b. The wound closure tag 100 at the leading end along the spine 3045 can rest at the bottom of the receiving port 3040. The tag 100 can be aligned with a push rod proximally aligned behind the anchor 110 and with the open end of the needle 3010 distally aligned in front of the anchor 110. As described above, after passing the needle 3010 through both sides of the wound, the trigger 3020 can be actuated to deliver the tag 100. When the trigger 3020 is actuated, the gears and racks within the housing drive the push rod distally, similar to the device 1000, to pass the push rod through the bottom of the receiving port 3040. When the push rod passes through the receiving port, the push rod contacts the proximal end of the first anchor 110 along the spine 3045 and pushes it distally into the proximal opening end of the needle 3010. The distal force of the push rod disengages the first anchor 110 from the spine 3045 with a pop, breaks it, or fractures it, and the first anchor 110 is pushed distally through the needle 3010 and delivered to the second side of the wound, similar to the device 1000. When the first anchor 110 is pushed distally, the first body 120 follows behind the anchor 110 along the body slot 3006 within the housing 3002, and the first spring member 130 is pulled distally with the body 120 but remains on the first side of the wound. When the trigger 3020 is released, the actuation process is reversed to retract the push rod proximally from the needle 3010 and the receiving port 3040. When the push rod is retracted proximally from the receiving port 3040, the second anchor 110 of the second tag 100 arranged along the spine 3045 can fall to a predetermined position at the bottom of the receiving port 3040 in preparation for the repeated actuation process, and the push rod can break or snap off the second anchor 110 from the spine 3045 during delivery.However, in other embodiments, various other tag advancement mechanisms can move the next tag 100 to align it for delivery. For example, a spring member within the housing can apply a downward pressure to the spine, or can be engaged from below the spine to pull the spine downward. A ratchet and / or gear mechanism can be disposed within the housing and can be actuated upon each withdrawal of the trigger to move the spine downward by a corresponding distance to align the next anchor. A plurality of tags 100 and spines 3045 can be loaded into a top-loading vertical cartridge that houses a spring member in an upper portion and provides a downward force to the spine 3045. The spine 3045 can be moved manually, etc.

[0047] In various embodiments, a plurality of wound closure tags can also be loaded from the side of the device. For example, FIG. 21 shows another embodiment of a delivery device 4000 for wound closure tags, similar to the delivery device 3000. The device 4000 has a housing 4002, a curved needle 4010, an actuating mechanism with a trigger 4020, and a receiving port 4040 for receiving a plurality of wound closure tags. The housing 4002 is in the shape of a pistol with a proximally angled pistol grip 4002a, from which the needle 4010 projects distally. The housing 4002 has a body slot 4006 similar to the body slot 4006, and the body of the wound closure tag passes along the body slot while the corresponding anchor is being delivered through the needle 4010. However, the body slot 4006 is on the upper surface of the housing 4002 rather than on the side. FIGS. 21 - 23 show a plurality of wound closure tags 350, but any wound closure tag can be used. The needle 4010 is configured similarly to the needle 3010, is loaded through a proximal opening end (not shown) within the housing 4002, and has a channel aligned with the receiving port 4040. The trigger 4020 of the actuating mechanism is similar to the trigger 3020, engages with the pistol grip 4002a of the housing 4002, and actuation of the trigger 4020 by pivoting the trigger 4020 towards the pistol grip 4002a can be achieved while the device 4000 is held by the pistol grip 4002a. Similar to the actuating mechanism of the device 3000, actuation of the trigger 4020 causes rotation of one or more gears (not shown) within the housing 4002, drives a rack (not shown) distally, and advances a push rod (not shown) distally along a slot aligned with the bottom of the receiving port 4040 and the proximal opening end of the needle 4010.

[0048] The receiving port 4040 is shaped to receive a plurality of wound closure tags 350 arranged continuously along the tag spine 4045 such that each anchor 360 of each tag 350 is vulnerable to connection to the tag spine 4045 as shown in FIG. 23. The distal end of the receiving port 4040 along the central axis of the housing 4002 acts as an alignment and stop surface for the next anchor 360 to be delivered, similar to the bottom of the receiving port 3040 in the housing 3002, which has its distal end aligned with the proximal opening end of the needle 4010 and its proximal end aligned with the push rod. The receiving port 4040 also has an anchor receiving channel (not shown) which is aligned such that each anchor 360 is loaded distally into the proximal opening end of the needle 4010 when it reaches the distal end of the receiving port 4040, receiving a plurality of anchors 360 connected horizontally through the side of the housing 4002 to the spine 4045. Also, the receiving port 4040 has a body channel (not shown) extending between the anchor receiving channel and the body slot 4006 on the housing 4002, such that a plurality of bodies 370 connected to the corresponding plurality of anchors 360 loaded into the device 4000 can move horizontally along the body channel and then distally along the body slot 4006 with their corresponding anchors 360 when delivered through the needle 4010. A corresponding plurality of spring members 380 extend vertically above the housing 4002 and are not received within the housing. A spine channel (not shown) is formed horizontally below the anchor receiving channel within the housing and can optionally extend completely through it. The spine channel receives the spine 4045 along it and extends horizontally beyond the distal end of the receiving port 4040. Thus, the first portion of the spine 4045 that had accommodated the already delivered anchors 360 has room to continue moving horizontally, such that the next anchor 360 to be delivered can maintain an accurately aligned state with the push rod and the needle 4010 at the distal end of the receiving port 4040 without interference from the spine 4045.

[0049] The receiving port 4040 is aligned with a tab housing 4042 having a retaining portion 4042a and a connecting member 4042b. The connecting member 4042b extends around the housing 4002 and connects the retaining portion 4042a to the side that aligns with the receiving port 4040 of the housing. The retaining portion 4042a is a generally rectangular object that receives a plurality of tags 350 and spines 4045 therein during use and provides protection to the plurality of anchors 350 and spines 4045. Further, the retaining portion 4042a may have one or more anchor advancement mechanisms, such as a spring or a rotatable knob, at the end opposite the receiving port 4040, which can apply a horizontal force to the spine 4045 to align and maintain the next tag 350 to be delivered with the needle 4010 and the push rod.

[0050] In use, device 4000 operates similarly to device 3000. A spine 4045 with a plurality of wound closure tags 350 attached thereto in a fragile manner can be loaded into a receiving port 4040, and a tab housing 4042 can be secured to a device housing 4002. A first wound closure tag 350 at the head along the spine 4045 aligns with a push rod behind a first anchor 360 that forms a column proximally and with a proximal opening end of a needle 4010 in front of the first anchor 360 distally, and can stop at the distal end of the receiving port 4040. After passing the needle 4010 through both sides of the wound, a trigger 4020 can be actuated to deliver the tag 350. When the trigger 4020 is actuated, gears and racks within the housing drive the push rod distally to pass the push rod through the distal end of the receiving port 4040. In this way, the push rod breaks off the first anchor 360 from the spine 4045 and pushes it distally into the proximal opening end of the needle 4010. The anchor 360 is biased distally through a channel of the needle 4010, and the body 370 extends across the wound and is delivered to the second side of the wound with the spring member 380 remaining on the first side. When the trigger 4020 is released, the actuation process is reversed to retract the push rod proximally from the needle 4010 and the receiving port 4040. When the push rod is retracted proximally from the receiving port 4040, a second anchor 360 of a second tag 350 that forms a column along the spine 4045 can be moved horizontally to a predetermined position. As described above, such movement can be caused by a spring or a rotatable knob within a retaining portion 4042a that applies a horizontal force to the spine 4045. However, in other embodiments, other mechanisms are possible, such as a spring member within the housing, and a ratchet and / or gear mechanism can be disposed within the housing, which is actuated upon each withdrawal of the trigger and the spine 4045 can be manually moved, and so on.

[0051] FIG. 22 shows another embodiment of a delivery device 5000 similar to the device 4000 having a side loading mechanism. The device 5000 has a housing 5002, a curved needle 5010, an actuating mechanism with a trigger (not shown), a receiving port 5040 for a plurality of wound closure tags, and a body slot 5006. However, the device 5000 does not have a tab housing 4042 thereon. A spine channel 5040c similar to the spine channel of the device 4000 extends generally horizontally through the device 5000 and opens on the side opposite the receiving port 5040. The spine channel 5040c receives a spine 4045 connected to a plurality of tags 350 therethrough, such that a first portion of the spine 4045, whose anchor 360 has already been removed, can extend horizontally away from the device 5000 during use.

[0052] Devices 3000, 4000, and 5000 have wound closure tags loaded in a direction perpendicular to the movement of the corresponding push rod. However, a plurality of wound closure tags can be loaded in a direction parallel to the push rod of the device. FIGS. 24A-24C show the loading and delivery portions of another embodiment of a delivery device for wound closure tags, similar to the above-described devices 3000, 4000, and 5000. However, the loading and delivery portions shown in FIGS. 24A-24C have two channels extending parallel to each other, namely, a push rod channel 6002 and a wound closure tag channel 6004, instead of having a side or top loading mechanism. The push rod channel 6002 receives a push rod 6010 therethrough during operation of the device, and the wound closure tag channel 6004 receives a plurality of wound closure tags 500 linearly and fragilely connected on a toothed spine 6020 therethrough. Although tags 500 are shown in FIGS. 24A-24D, any wound closure tag can be used, such as wound closure tag 600 on spine 6030 of FIG. 25. The wound closure tag channel 6004 has a spine channel portion 6002a, an anchor channel portion 6002b, a body channel portion 6002c, and a spring member channel portion 6002d, which respectively receive the corresponding spine 6020, anchor 510, body 520, and spring member 530 therein when the spine 6020 and the plurality of tags 500 are loaded into the device. The spine 6020 and the plurality of tags 500 can be inserted into the wound closure tag channel 6004 from the proximal end of the device by sliding them distally. The push rod channel 6002 and the wound closure tag channel 6004 initially extend side by side in the housing of the device from the proximal portion to the distal end in a direction parallel to each other, as shown in FIGS. 24B and 24C. However, as emphasized by the black bar in FIG. 24C, the wound closure tag channel 6004 transitions into alignment with the push rod channel 6002 and merges with the push rod channel 6002 at a point that is proximal to the needle of the device but distal to the push rod 6010 itself.Accordingly, the wound closure tag channel 6004 effectively terminates within the push rod channel 6002. At the point where the wound closure tag channel 6004 merges with the push rod channel 6002, the spine 6020 advances distally, and the anchor 510 of the next tag 500 to be continuously delivered advances to the merging portion of the push rod channel 6002, which is proximal to the needle and distal to the push rod 6010, while any subsequent tag 500 remains slightly proximal to the merging point in the wound closure tag channel 6004. Thus, the anchor 510 of the next tag 500 to be delivered remains stationary alone within the merging portion of the push rod channel 6002 with the body 520 and the spring member 530 extending vertically above the merging portion of the push rod channel 6002. When the device is actuated using any of the mechanisms described above, such as by the distal advancement of the rack 6012 connected to the push rod 6010, the push rod 6010 advances distally through the push rod channel 6002, including the merging portion of the channel where the next tag 500 is positioned. The anchor 510 of the tag 500 to be delivered is snapped, cut, or broken off from the spine 6020, and the push rod 6010 pushes the anchor 510 distally into the channel of the needle and extrudes it from the distal side to deliver it to the second side of the wound. Then, the push rod 6010 is retracted proximally from the merging portion of the push rod channel 6002, and the spine 6020 is advanced again to load the next tag 500 into the merging portion of the push rod channel 6002. Here, the merging portion of the push rod channel 6002 has been described, but the merging portion may be the proximal open end of the needle, and as a result, the needle is directly connected to the push rod channel 6002 and the wound closure tag channel 6004 at the merging point. The spine 6020 advances distally in a controlled manner by the engagement of teeth and gears arranged along the bottom surface of the spine 6020. The gears can be automatically rotated during the operation of the device. However, various other advancement mechanisms can be used, such as manual advancement, spring mechanisms, rotation and / or actuation of various levers, knobs, buttons, release switches, etc.

[0053] In other embodiments, the spine can be eliminated and the anchors of the plurality of wound closure tags can be either frangibly connected to one another or placed individually directly. For example, FIG. 26 shows a delivery device 7000 similar to the above-described device. The device 7000 has a housing 7002, a curved needle 7010, a receiving port 7040 extending from the proximal end to the distal end of the housing 7002, and an actuating mechanism having a push rod 7030. A plurality of wound closure tags 430 are provided, and these tags are frangibly connected to one another by the anchors 410 being linearly and continuously engaged end to end. Tags 400 are shown here, but any wound closure tag can be used. The plurality of wound closure tags 400 are loaded into the receiving port 7040 on their proximal ends and are continuously placed distally through the housing 7002 while waiting to be deployed. The anchor 410 is held within the housing 7002 with the body 420 extending through the housing 7002 along the receiving port 7040, and the spring member 430 extends vertically above the housing 7002. The first tag 400 to be delivered is pushed horizontally out of the receiving port 7040, breaking or separating the corresponding anchor 410 from the remaining anchors 410 and entering the delivery channel 7042. Thus, the anchor 410 of the corresponding tag 400 is aligned within the delivery channel 7042 with the push rod 7030 distally and the proximal opening end of the needle 7010 proximally. Similar to the above-described actuating mechanism, when the device 7000 is actuated, the push rod 7030 is driven distally forward through the delivery channel 7042, through the proximal opening end, and along the channel of the needle 7010. The push rod 7030 encounters the anchor 410 of the tag 400 and biases it distally for delivery, and then the anchor 410 of the tag is delivered to the second side across the wound. The body 420 of the delivered tag 400 passes through the delivery channel 7042 and follows behind the anchor 410 across the wound, and the spring member 430 of the delivered tag 400 moves distally with the movement of the anchor 410 but remains on the first side of the wound.Using various different mechanisms such as the interaction between the gear and the push member, the spring mechanism, and the manual force caused by the operation of the device, the delivered tag 400 can be destroyed and moved horizontally into the delivery channel 7042.

[0054] Some delivery devices can also use a mechanical operating mechanism similar to the above-described device while using manual loading. For example, FIGS. 27A and 27B show a delivery device 8000 similar to the device 1000 for delivering a wound closure tag. The device 8000 includes a housing 8002, a curved needle 8010, an operating mechanism with a trigger 8020, a tag loading port 8040, and a body slot 8006 within the housing 8002. An anchor of a wound closure tag, such as one of the wound closure tags described above, is inserted into the tag loading port 8040. Within the tag loading port 8040, the anchor is aligned at a position proximal to the open end of the needle 8010 and at a position distal to the push rod. After the needle 8010 passes through the two sides of the wound, the trigger 8020 can be actuated to cause distal advancement of the push rod through a mechanism similar to that described above. The push rod can push the anchor distally into and through the needle 8010, such that the anchor is delivered to the second side of the wound. The corresponding body of the tag follows behind the delivered anchor, slides along the body slot 8006, and the corresponding spring member moves distally with the delivery of the anchor but remains on the first side of the wound. A second tag can be loaded into the device 8000. The tag can optionally also be loaded through a discharge port on the needle 8010 as described in detail above.

[0055] A trigger for actuation is shown, and various manual, gravity feed, or spring or rotational mechanisms for advancement of the wound closure tags are discussed, although various different actuation and advancement mechanisms such as slider releases and / or push buttons on the housing can be used in other embodiments. A removable cartridge can also be used that houses a plurality of wound closure tags that are serially connected, stacked, and / or arranged, and these can be clipped into the device using various clips, slider releases, push buttons, etc. and then released from the device. Further, while various spines are shown, other mechanisms can be used for indexing and deploying the wound closure tags, such as, for example, weakly connecting the anchors directly together, weakly connecting the spring members directly together, or some combination of these two. The various device embodiments described herein can also generally mimic a needle driver in ergonomic shape, method of use, and overall design to enable a surgeon to feel comfortable when first using the various delivery devices.

[0056] In fact, the wound closure tags described herein have been shown to provide faster, more effective healing, and better stress displacement compared to sutures or staples. For example, FIGS. 28A - 28C show a wound 9000 at day 0, day 14, and day 28, respectively, closed using the wound closure tag 100 described above. The wound 9000 shows significant healing such that the incision line almost completely disappears by day 28. A similar wound 9002 is closed using sutures, and FIGS. 29A - 29C show the healing at day 0, day 14, and day 28, respectively. The wound 9002 is closed by day 28, but the incision line is still visible. Finally, another similar wound 9004 is closed using staples, and FIGS. 30A - 30C show the healing at day 0, day 14, and day 28, respectively. The wound 9004 still shows signs that the incision is in the process of fully closing at day 28. Thus, the wound closure tags provide improved healing compared to sutures and staples.

[0057] Further, FIGS. 31A and 31B show a tensile stress or tension test applied to suture 9010 used to close a wound within tissue. As seen in FIG. 31B, suture 9010 caused skin lacerations and tears through the wound due to a non-uniform distribution of the transverse force. As shown in FIGS. 32A and 32B, a second tensile stress or tension test was performed on wound closure tag 9012, similar to tag 100 described herein. Tag 9012 significantly reduced skin lacerations and tears caused by a greater distribution of force through the wound, as seen in FIG. 32B.

[0058] All of the devices disclosed herein can be designed to be discarded after a single use, or they can be designed to be used multiple times. However, in either case, the devices can be reconditioned for reuse after at least one use. Reconditioning can include any combination of a device disassembly step, subsequent cleaning or replacement steps of specific components, and subsequent reassembly steps. In particular, the device can be disassembled and any number of specific components or parts of the device can be selectively replaced or removed in any combination. When specific components are cleaned and / or replaced, the device can be reassembled for subsequent use in a reconditioning facility or by the surgical team immediately prior to a surgical procedure. One of ordinary skill in the art will understand that various techniques for disassembly, cleaning / replacement, and reassembly can be utilized for reconditioning the device. The use of such techniques, and the resulting reconditioned devices, are all within the scope of this application.

[0059] The devices disclosed herein are preferably sterilized prior to use. This can be done by any number of methods known to those of skill in the art, including beta or gamma radiation, ethylene oxide, steam, and liquid baths (e.g., cold pervasion). The device is preferably sealed when implanted. This can be done by any number of methods known to those of skill in the art.

[0060] Furthermore, in the present disclosure, components named in a similar manner in the embodiments generally have similar features. Thus, within a particular embodiment, each feature of each similarly named component is not necessarily described in sufficient detail. Additionally, in the description of the disclosed systems, devices, and methods, to the extent that linear or circular dimensions are used, such dimensions are not intended to limit the types of shapes that can be used with such systems, devices, and methods. Those skilled in the art will understand that for any geometric shape, what corresponds to such linear and circular dimensions can be readily determined. The size and shape of the systems and devices, as well as their components, can depend at least on the anatomical structure of the subject to which the systems and devices are applied, the size and shape of the components used in the systems and devices, and the methods and procedures in which the systems and devices are used.

[0061] Those skilled in the art will understand further features and advantages of the described devices and methods based on the above-described embodiments. Accordingly, the present disclosure is not limited by what is specifically shown and described except as indicated by the appended claims. All publications and references cited herein are hereby expressly incorporated by reference in their entirety.

[0062] 〔Embodiments〕 (1) A system for closing a wound, comprising: at least one wound closure member having a first anchor, a second anchor, and a body extending between the first anchor and the second anchor and connecting the first anchor and the second anchor, wherein the second anchor is positioned on a second side of the wound, the first anchor is positioned on a first side of the wound, and the body is configured to close the wound by applying an eversion force when extending through the tissue of the wound; A curved delivery needle having a proximal opening end, a distal end having a discharge port and terminating at a distal tip, and a channel extending between the proximal opening end and the discharge port, wherein the channel is configured to slidably receive the anchor, the curved delivery needle. A push rod slidably coupled to the curved delivery needle and configured to translate the anchor of the wound closure member along the channel from the proximal opening end of the delivery needle to the discharge port. A system comprising. (2) The system according to embodiment 1, wherein the first anchor is a crossbar and the second anchor is a spring member selected from the group consisting of a plurality of flat or non-flat arms, a plurality of convex or concave arms, a hemispherical structure, a semi-circular panel extending towards the anchor, and a helix. (3) The system according to embodiment 2, wherein the second anchor is configured to apply an adjustable eversion closing force based on the wound and the movement of the selected second anchor. (4) The system according to embodiment 1, wherein the at least one wound closure member comprises a plurality of wound closure members that are fragilely connected to each other. (5) The system according to embodiment 4, wherein the plurality of wound closure members are fragilely connected by a spine.

[0063] (6) The system according to embodiment 1, further comprising a handle, wherein the handle is coupled to the proximal end of the delivery needle, configured to receive the push rod through the handle and guide the push rod into the needle, and the handle has a trigger configured to slidably move the push rod. (7) The system according to embodiment 6, further comprising a removable and replaceable cartridge configured to receive the at least one wound closure member therein and configured to be removably fitted to the handle, wherein the at least one wound closure member is translatable along the channel of the delivery needle from the cartridge when the push rod is actuated. (8) The system according to embodiment 1, wherein the channel of the delivery needle has an upward slope terminating at the discharge port. (9) The system according to embodiment 1, wherein the distal tip of the delivery needle includes a cutting tip. (10) A method of closing a wound in tissue, comprising: passing a curved delivery needle through tissue on a first side and a second side of the wound; passing a first anchor of a wound closure member through the channel of the needle from the first side to the second side of the wound, the first anchor exiting through a discharge port at a distal end of the needle on the second side and engaging an outer surface of the tissue on the second side; retracting the delivery needle to release a second anchor of the wound closure member, the second anchor engaging an outer surface of the tissue on the first side of the wound; wherein a body connected between the first anchor and the second anchor passes through the tissue and extends through the wound; and wherein the wound closure member applies an eversion force to the tissue, moving the first side and the second side of the tissue towards each other, thereby closing the wound.

[0064] (11) The method according to embodiment 10, wherein passing the anchor includes advancing a push rod along the channel of the needle to advance the anchor through the needle. (12) Before passing the anchor, further comprising advancing the first anchor into the proximal end of the channel of the delivery needle such that the body extends through a slot formed in the side wall of the needle and the second anchor is positioned outside the needle, the method according to embodiment 10. (13) Passing the first anchor includes actuating a trigger coupled to a handle on the proximal end of the delivery needle to advance a push rod along the channel of the needle from the proximal opening end to the discharge port, thereby passing and discharging the first anchor, the method according to embodiment 10. (14) Further comprising rotating the cartridge to align a third anchor of a second wound closure member with the channel of the needle, the method according to embodiment 13. (15) The first anchor is a crossbar, and the second anchor is a spring member selected from the group consisting of a plurality of flat or non-flat arms, convex or concave arms, hemispherical structures, a semi-circular panel extending towards the anchor, and a helix. Retracting the delivery needle to release the second anchor includes the wound closure member applying an adjustable eversion closing force based on the movement of the wound and the selected second anchor, the method according to embodiment 10.

[0065] (16) A system for closing a wound, At least one wound closure member having a rigid first anchor, a spring member, and a body extending between the first anchor and the spring member and connecting the first anchor and the spring member, wherein the spring member is configured to apply an adjustable eversion closing force to the wound based on the movement of the wound and the shape of the spring member when the spring member is positioned on a second side of the wound, the rigid first anchor member is positioned on a first side of the wound, and the body extends through the tissue of the wound. A curved delivery needle having a proximal opening end, a distal end having a discharge port and terminating at a distal tip, and a channel extending between the proximal opening end and the discharge port, wherein the channel is configured to slidably receive the anchor, the curved delivery needle; A push rod slidably coupled to the curved delivery needle and configured to translate the anchor of the wound closure member along the channel from the proximal opening end of the delivery needle to the discharge port; A system comprising. (17) The system of embodiment 16, wherein the rigid first anchor is a crossbar and the shape of the spring member is selected from the group consisting of a plurality of non-planar arms, a plurality of convex or concave arms, a hemispherical structure, a semi-circular panel extending towards the anchor, and a helix. (18) The system of embodiment 17, wherein each selected shape of the spring member is configured to apply a different adjustable eversion closing force to the wound. (19) The system of embodiment 16, wherein the at least one wound closure member includes a plurality of wound closure members that are fragilely connected to each other. (20) The system of embodiment 19, wherein the plurality of wound closure members are fragilely connected by a spine.

[0066] (21) The system of embodiment 16, further comprising a handle, the handle being coupled to the proximal end of the delivery needle, configured to receive the push rod through the handle and guide the push rod within the needle, the handle having a trigger configured to slidably move the push rod. (22) Further comprising a removable and replaceable cartridge configured to receive the at least one wound closure member therein and configured to be removably fitted to the handle, wherein the at least one wound closure member is translatable from the cartridge along the channel of the delivery needle upon actuation of the push rod, the system of embodiment 21. (23) The system of embodiment 16, wherein the channel of the delivery needle has an upward slope terminating at the discharge port. (24) The system of embodiment 16, wherein the distal tip of the delivery needle includes a cutting tip. (25) A method of closing a wound in tissue, passing a curved delivery needle through tissue on a first side and a second side of the wound, passing a rigid first anchor of a wound closure member through the channel of the needle from the first side to the second side of the wound, the rigid first anchor exiting through a discharge port at the distal end of the needle on the second side and engaging the outer surface of the tissue on the second side, retracting the delivery needle to release a spring member of the wound closure member, the spring member engaging the outer surface of the tissue on the first side of the wound, comprising, a body connected between the rigid first anchor and the spring member passes through the tissue and extends through the wound, the spring member applies an adjustable eversion closing force to the tissue, moving the first side and the second side of the tissue towards each other to close the wound, the adjustable eversion closing force is adjustable based on the movement of the wound and the shape of the spring member, the method.

[0067] (26) The method of embodiment 25, wherein passing the anchor includes advancing a push rod along the channel of the needle to advance the anchor through the needle. (27) Before passing the anchor, further comprising advancing the rigid first anchor into the proximal end of the channel of the delivery needle, such that the body extends through a slot formed in the sidewall of the needle and the spring member is positioned external to the needle, the method of embodiment 25. (28) Passing the rigid first anchor includes actuating a trigger coupled to a handle on the proximal end of the delivery needle to advance a push rod along the channel of the needle from the proximal opening end to the discharge port, thereby passing and discharging the rigid first anchor, the method of embodiment 25. (29) The method of embodiment 28, further comprising rotating the cartridge to align a second anchor of a second wound closure member with the channel of the needle. (30) The rigid first anchor is a crossbar, and the shape of the spring member is selected from the group consisting of a plurality of non-flat arms, convex or concave arms, a hemispherical structure, and a semi-circular panel extending towards the anchor, and a helix. Each selected shape of the spring member applies a different adjustable eversion closing force to the wound, the method of embodiment 25.

Claims

1. A system for closing a wound, comprising: at least one wound closure member having a first anchor, a spring member, and a body extending between the first anchor and the spring member and connecting the first anchor and the spring member, wherein the first anchor and the spring member are of different shapes, and the spring member is configured to apply an adjustable eversion closing force to the wound based on movement of the wound and the shape of the spring member when the spring member is positioned on a second side of the wound, the first anchor is positioned on a first side of the wound, and the body extends through the tissue of the wound; a curved delivery needle having a proximal opening end, a distal end terminating in a discharge port, and a channel extending between the proximal opening end and the discharge port, the channel being configured to slidably receive the first anchor; a push rod slidably coupled to the curved delivery needle and configured to translate the first anchor of the wound closure member along the channel from the proximal opening end of the curved delivery needle to the discharge port; comprising; wherein the spring member includes at least two arms, each arm having first and second ends, the first ends being connected to the body, each arm curving toward the first anchor from the first end to the second end, each arm having a rest state and a compressed state, and each arm being configured to return from the compressed state to the rest state in which the arm is more curved than in the compressed state.

2. The system of claim 1, wherein the first anchor is a crossbar.

3. The system of claim 1, wherein the spring member comprises three of the arms.

4. The system of claim 1, wherein the second end of each arm has a sphere.

5. The system of claim 1, wherein the spring member includes four of the arms and one ring, and the second ends of the arms are connected to the ring.

6. The spring member includes the two arms, the two arms being the first and second arms, the spring member further including third and fourth arms, the third and fourth arms each having first and second ends, the first end of the third arm and the first end of the fourth arm being connected to each other to form a tip, the second end of the third arm being connected to the second end of the first arm, and the second end of the fourth arm being connected to the second end of the second arm, the system according to claim 1.

7. The system according to claim 1, wherein the arm is a plate arm.

8. The system according to claim 7, wherein the plate arm terminates in a cylindrical bar, the cylindrical bar defining the second end.

9. The system according to claim 1, wherein the arm is a panel having a shape that widens from the first end towards the second end.

10. The system according to claim 1, wherein the at least one wound closure member includes a plurality of wound closure members that are weakly connected to each other.

11. The system according to claim 10, wherein the plurality of wound closure members are weakly connected by a spine.

12. The system according to claim 1, further including a handle, the handle being connected to the proximal end of the curved delivery needle, configured to receive the push rod through the handle and guide the push rod into the curved delivery needle, the handle having a trigger configured to slidably move the push rod.

13. The system according to claim 12, further including a removable and replaceable cartridge configured to receive the at least one wound closure member therein and removably fit to the handle, the at least one wound closure member being translatable along the channel of the curved delivery needle from the cartridge upon actuation of the push rod.

14. The system according to claim 1, wherein the channel of the curved delivery needle has an upward slope terminating at the discharge port.

15. The system according to claim 1, wherein the distal tip of the curved delivery needle includes a cutting tip.

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