Wound closure
Patent Information
- Application Number
- JP2024224001
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2019-04-01
- Filing Date
- 2024-12-19
- Publication Date
- 2025-03-07
- Estimated Expiration
- Not applicable · inactive patent
Smart Images

Figure 2025031812000001_ABST
Abstract
Description
Content of disclosure
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 827,590, filed April 1, 2019, entitled "Wound Closure," which is hereby incorporated by reference in its entirety.
[0002] [Field] SUMMARY OF THE DISCLOSURE Surgical devices, systems and methods for closing a wound are provided.
[0003] 〔background〕 Wound closure, for example, closure of 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, where necrotic tissue along the top surface of the skin is pushed inward toward the wound, which can slow healing time and can lead to increased scarring. Sutures and staples can cause scarring and infection, and can be painful during application. Medical adhesives generally can be ineffective in permanently or substantially closing a wound, and are often used as a dressing rather than any type of permanent closure mechanism.
[0004] Therefore, there is a need for improved wound closure techniques.
[0005] 〔overview〕 Provided herein are methods, devices and systems for implanting a wound closure tag for closing a wound.
[0006] In one aspect, a system for closing a wound is provided having at least one wound closure member comprising a first anchor, a second anchor, and a body extending between and connecting the first anchor and the second anchor. The wound closure member is configured to provide an eversion closure force to the wound when the first anchor is positioned on a first side of the wound and the second anchor is positioned on a second side of the wound and the body extends through tissue of the wound. The system also has a curved delivery needle comprising a proximal open end, a distal end having an ejection port and terminating in a distal tip, and a channel extending between the proximal open end and the ejection port. The channel is configured to slidably receive the first anchor. The system also has 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 open end of the delivery needle to the ejection port.
[0007] The system may have many variations. For example, the first anchor may be a crossbar and the second anchor may 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 semicircular panel extending toward the anchor, and a helix. The second anchor may also be configured to apply an adjustable eversion closure force based on the movement of the wound and the selected second anchor. In some examples, the at least one wound closure member may include a plurality of wound closure members frangibly connected to each other. Also, the plurality of wound closure members may be frangibly connected by a spine. The system may also include a handle, which is coupled to the proximal end of the delivery needle and configured to receive a push rod through the handle and guide the push rod into the needle. The handle may have a trigger configured to slidably move the push rod. In one example, the system can include a removable and replaceable cartridge configured to receive at least one wound closure member therein and configured to be removably mated to the handle, where the at least one wound closure member is translatable from the cartridge along the delivery needle channel upon actuation of the push rod. The delivery needle channel can also have an upward slope terminating in an ejection port. In another example, the distal tip of the delivery needle can include a trocar tip.
[0008] In another aspect, a method of closing a wound in tissue is provided, which includes passing a curved delivery needle through tissue on a first and second side of the wound. The method also includes passing a first anchor of the wound closure member through a channel of the needle from the first side to the second side of the wound such that the first anchor exits an ejection port at the distal end of the needle on the second side and engages an 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 an outer surface of the tissue on the first side of the wound. A body coupled between the first anchor and the second anchor extends through the tissue across the wound. The wound closure member also 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 a variety of different embodiments. For example, threading the first anchor can include advancing a push rod along the channel of the needle to advance the first anchor through the needle. The method can also include advancing the first anchor into the proximal end of the channel of the delivery needle before threading the first anchor, such that the body extends through a slot formed in a sidewall of the needle and the second anchor is positioned outside of the needle. Threading the first anchor can also include activating 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 open end to the ejection port, thereby threading and ejecting the first anchor. In one example, the method can also include rotating the cartridge to align a third anchor of the second wound closure member with the channel of the needle. In some examples, the first anchor may be a crossbar and the second anchor may 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 semicircular panel extending toward the anchor, and a spiral. Further, retracting the delivery needle to release the second anchor may 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-described embodiments will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which: The drawings are not intended to be drawn to scale, and for purposes of clarity, not every component has been labeled in every drawing. [Brief description of the drawings]
[0011] [Figure 1] 1 is a perspective view of one embodiment of a wound closure tag. [Diagram 2] 2 is a cross-sectional side view of the wound closure tag of FIG. 1 implanted in tissue to close an incision. [Diagram 3] 3 is a cross-sectional perspective view of the wound closure tag and incision of FIG. 2. [Figure 4] 13 is a perspective view of another embodiment of a wound closure tag. FIG. [Diagram 5] 13 is a perspective view of another embodiment of a wound closure tag. FIG. [Figure 6] 13 is a perspective view of another embodiment of a wound closure tag. FIG. [Figure 7] 13 is a perspective view of another embodiment of a wound closure tag. FIG. [Figure 8] 13 is a perspective view of another embodiment of a wound closure tag. FIG. [Figure 9] 9 is a cross-sectional side view of the wound closure tag of FIG. 8 implanted in tissue to close an incision. [Figure 10] FIG. 10 is a cross-sectional side view of the wound closure tag and incision of FIG. [Figure 11A] 13 is a perspective view of another embodiment of a wound closure tag. FIG. [Figure 11B] FIG. 11B is a side view of the wound closure tag of FIG. [Figure 11C] FIG. 11B is a perspective view of the wound closure tag of FIG. [Figure 12] 13 is a perspective view of another embodiment of a wound closure tag. FIG. [Figure 13A] 13 is an end view of another embodiment of a wound closure tag looking from the spring member towards the anchor. FIG. [Figure 13B]13 is an end view of another embodiment of a wound closure tag looking from the spring member towards the anchor. FIG. [Figure 13C] 13 is an end view of another embodiment of a wound closure tag looking from the spring member towards the anchor. FIG. [Figure 13D] 13 is an end view of another embodiment of a wound closure tag looking from the spring member towards the anchor. FIG. [Figure 13E] 13 is an end view of another embodiment of a wound closure tag looking from the spring member towards the anchor. FIG. [Figure 13F] 13 is an end view of another embodiment of a wound closure tag looking from the spring member towards the anchor. FIG. [Figure 13G] 13 is an end view of another embodiment of a wound closure tag looking from the spring member towards the anchor. FIG. [Figure 13H] 13 is an end view of another embodiment of a wound closure tag looking from the spring member towards the anchor. FIG. [Figure 13I] 13 is an end view of another embodiment of a wound closure tag looking from the spring member towards the anchor. FIG. [Figure 14A] FIG. 13B is a side view of the wound closure tag of FIG. 13A. [Figure 14B] FIG. 13C is a side view of the wound closure tag of FIG. 13B. [Figure 14C] FIG. 13D is a side view of the wound closure tag of FIG. 13C. [Figure 14D] FIG. 13E is a side view of the wound closure tag of FIG. 13D. [Figure 14E] FIG. 13F is a side view of the wound closure tag of FIG. 13E. [Figure 14F] FIG. 13F is a side view of the wound closure tag of FIG. 13F. [Figure 14G] FIG. 13H is a side view of the wound closure tag of FIG. 13G. [Figure 14H] FIG. 13C is a side view of the wound closure tag of FIG. 13H. [Figure 14I] FIG. 13I is a side view of the wound closure tag of FIG. 13I. [Figure 15A] 13 is a perspective view of another embodiment of a wound closure tag. FIG. [Figure 15B] FIG. 15B is a perspective view of the wound closure tag of FIG. 15A. [Figure 16A] FIG. 1 is a perspective view of one embodiment of a delivery needle. [Figure 16B] FIG. 16B is a perspective view of the delivery needle of FIG. 16A. [Figure 16C] FIG. 16B is a perspective view of the delivery needle of FIG. 16A having a wound closure tag therein. [Figure 17A] 2 is a cross-sectional side view of one embodiment of implanting the wound closure tag of FIG. 1 into tissue to close an incision. [Figure 17B] FIG. 17B is a cross-sectional side view of the wound closure tag and incision of FIG. 17A. [Figure 17C] FIG. 17B is a cross-sectional side view of the wound closure tag and incision of FIG. 17A. [Figure 17D] 17B is a cross-sectional side view of the wound closure tag of FIG. 1 after successful delivery to the wound of FIG. 17A. [Figure 18A] FIG. 11C is a perspective view of another embodiment of a delivery needle having a wound closure tag of FIGS. [Figure 18B] FIG. 16B is a perspective view of the delivery needle of FIG. 16A. [Figure 19A] FIG. 13 is a perspective view of one embodiment of a delivery device for delivering a wound closure tag. [Figure 19B] FIG. 19B is a cross-sectional side view of the delivery device of FIG. 19A. [Figure 19C] FIG. 19B is a front-to-back view of the delivery device of FIG. 19A. [Figure 19D] FIG. 19B is an exploded perspective view of the delivery device of FIG. 19A. [Figure 19E] FIG. 19B is a perspective view of the internal components of the delivery device of FIG. 19A. [Figure 19F] FIG. 19B is a perspective view of a wound closure tag cartridge that can be used with the delivery device of FIG. 19A. [Figure 19G] FIG. 19F is a perspective view of the proximal side of the cartridge of FIG. 19F. [Figure 19H] FIG. 19 is a side view of the housing of delivery device 19A held in a supination orientation. [Figure 19I] FIG. 19 is a perspective view of the housing of a delivery device 19A held in a neutral orientation. [Figure 19J]FIG. 19 is a side view of the housing of delivery device 19A held in a pronated orientation. [Figure 19K] FIG. 13 is a cross-sectional side view of another embodiment of a cartridge. [Figure 20A] 11 is a perspective view of another embodiment of a delivery device for a wound closure tag, such as the illustrated wound closure tag of FIG. 1. [Figure 20B] FIG. 20B is a perspective view of the delivery device of FIG. [Figure 21] 13 is a perspective view of another embodiment of a delivery device for delivering a wound closure tag. FIG. [Figure 22] 13 is a perspective view of a distal end of another embodiment of a delivery device for delivering a wound closure tag. FIG. [Figure 23] 8 is a perspective view of a plurality of wound closure tags of FIG. 7 connected to a spine. [Figure 24A] 13 is a perspective view of the internal components of another embodiment of a delivery device for delivering a wound closure tag. [Figure 24B] FIG. 24B is a side view of the internal components of the delivery device of FIG. 24A. [Figure 24C] FIG. 24B is a top view of the internal components of the delivery device of FIG. 24A. [Figure 24D] FIG. 11C is a perspective view of a plurality of wound closure tags of FIGS. 11A-11C on a spine. [Diagram 25] 13 is a perspective view of a plurality of wound closure tags of FIG. 12 connected to a spine. [Figure 26] 13 is a perspective view of a distal end of another embodiment of a delivery device for delivering a wound closure tag. FIG. [Figure 27A] 13 is a perspective view of another embodiment of a delivery device for a wound closure tag. FIG. [Figure 27B] FIG. 27B is a perspective view of the delivery device of FIG. 27A. [Figure 28A] 2 is a photograph of an incision closed with multiple wound closure tags, such as the wound closure tag of FIG. 1, at day 0. [Figure 28B] 28B is a photograph of the incision of FIG. 28A on day 14. [Figure 28C] 28B is a photograph of the incision of FIG. 28A on the 28th day. [Figure 29A] Photograph of the incision closed with sutures on day 0. [Figure 29B] 29B is a photograph of the incision of FIG. 29A on day 14. [Figure 29C] 29B is a photograph of the incision of FIG. 29A on day 28. [Figure 30A] Photograph of incision closed with staples on day 0. [Figure 30B] 30B is a photograph of the incision of FIG. 30A on day 14. [Figure 30C] 30B is a photograph of the incision of FIG. 30A on day 28. [Figure 31A] 1 is a photograph of a stress test on the sutures used to close the incision. [Figure 31B] 31B is a photograph of the incision of FIG. 31A after stress testing. [Figure 32A] 2 is a photograph of a stress test on the wound closure tag of FIG. 1 used to close an incision. [Figure 32B] 32B is a photograph of the incision of FIG. 32A after stress testing.
[0012] Detailed Description Certain exemplary embodiments will now be described to provide a general understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will appreciate 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 invention is defined only by the claims. Features illustrated or described in connection with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
[0013] Furthermore, in this disclosure, similarly named components of an embodiment generally have similar characteristics, and therefore, within a particular embodiment, each feature of each similarly named component is not necessarily described in full detail. Furthermore, to the extent that linear or circular dimensions are used in describing the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that may be used with such systems, devices, and methods. Those skilled in the art will understand that the equivalent of such linear and circular dimensions for any geometric shape may be readily determined. The size and shape of the systems and devices, and their components, may 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 for which the systems and devices are used, 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, with one or more wound closure members. For example, a wound closure member is provided having an anchor at its distal end, a spring member at its proximal end, and a body extending between the two. The anchor can be configured to be delivered through tissue with a needle delivery device having a curved needle that penetrates the tissue on a first and second side 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 to extend between the two sides of the wound. The spring member can remain on the first side of the wound and anchor itself against the tissue on the first side. This can provide 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 surrounding the wound flexes and moves, the spring member can adjust the applied tensile force to maintain a generally corresponding closing force to close the wound, which increases or decreases based on the movement of the tissue. Furthermore, the anchor and body are implanted using a curved needle, so that after implantation, the anchor and spring member rest against the outer surface of the tissue, and the body extends downward into the tissue in a generally semicircular shape to connect the anchor and spring member. This generally semicircular path through the wound exerts an upward force on the tissue along the wound, while the wound closure member exerts a constantly modulated closure force, which causes the wound to evert or wrinkle the skin at the wound site upward. Wound eversion can promote faster healing, better blood flow, and less scarring along the wound, and the wound closure member can also avoid or reduce tissue strangulation at the wound site that leads to wound inversion or poor closure and scarring. The wound closure member can also enable a more rapid closure process.
[0015] The wound closure member may be delivered to tissue with a delivery device. In one embodiment, the wound closure member may be delivered across the tissue of the wound using a needle having a curved distal portion, a channel extending at least partially therethrough, and an ejection port at a distal end. The needle may be threaded through a first and second side of the wound, and an anchor of the wound closure member may be threaded through the channel of the needle from the first side to the second side of the wound and exit from an ejection port at the distal end of the needle at the second side of the wound. The needle may 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 may be left by the needle on the first side of the wound to provide a secure and flexible engagement at the first side, thereby closing the wound.
[0016] The needles can be incorporated into a variety of different delivery devices, and a variety of activators can be used to drive the anchors of the wound closure member through the channels of the needles and out the ejection ports. A variety of delivery devices can also be used that incorporate one or more wound closure members therein, configured to be manually loaded into the device or automatically deployed through a variety of cartridge delivery systems described below.
[0017] FIG. 1 illustrates 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 across tissue from a first side 152 to a second side 154 of a wound 150 through a curved needle, as described below, so that the anchor engages and rests against an exterior tissue surface 156 of 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 semicircular path through the tissue. The spring member 130 is coupled to the anchor 110 through the body 120 and is designed to remain on the first side 152 of the wound so as not to pass through tissue. Instead, the spring member engages with and acts to secure the external tissue surface 158 of the first side 152 of the wound 150 after delivery. The spring member 130 is a flexible elastic body that flexes and bends as the tissue surrounding the wound moves, so that the tag 100 can apply a closure force that is constantly adjusted as the patient moves or repositions by allowing the spring member 130 to bend or resist movement depending on the amount the patient moves. Thus, the anchor 110, body 120, and spring member 130 work together to apply an effective tensile closure 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 shown by the arrows in Figure 3, a constantly adjusted tensile closure force of the tag 100 can be applied to the wound 150 along the semi-circular embedding path of the body 120 that extends below the surface of the wound. This therefore applies a closure force that draws the first and second sides of the wound together as shown by the arrows in Figure 3, as well as applying an upward or pulling force, which results in eversion of the wound and a better healing outcome.
[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 represents a substantially second anchor. Thus, the anchor and the spring member may represent similar components, and various other second anchors or spring members are possible, as described below. The body 120 extends perpendicularly between the anchor 110 and the spring member 130. The wound closure tag 100 is generally I-shaped, although various different shapes and orientations are possible for the spring member and / or anchor, as described below. 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 using different designs or different flexibilities for the spring member 130. While the illustrated body 120 has a fixed length, 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 constructed of a variety of materials, such as plastics, metals, medical elastomers, polymers, hydrogels, nitinol, biological tissue, absorbable, non-absorbable, and the like, and various portions of the tag 100, such as the spring member 130, as described below, can be constructed of a variety of materials. The tag 100 can have a variety of dimensions based on the desired use of the tag 100. However, the body 120 can have dimensions of about 4.0-12.0 mm, more preferably about 6.0-9.0 mm in length, and about 0.05-0.40 mm, more preferably about 0.10-0.35 mm in diameter. Additionally, the anchor 110 can have dimensions of about 3.0 mm-7.0 mm, more preferably about 4.0 mm-6.0 mm in length, and about 0.2 mm-0.6 mm, more preferably about 0.3 mm-0.5 mm in diameter. 1 can have similar dimensions as the anchor 100, although the spring member can have a variety of different configurations in different embodiments, as described below. The wound closure tag 100 can be positioned within the patient's skin at various depths and distances from the wound 150, for example, the anchor 110 and spring member 130 can extend through the patient's skin and be positioned about 3-4 mm away from the wound 150 on either side thereof.
[0020] As mentioned above, many different configurations of the spring member can be used depending on the desired wound closure application and the desired tensile closure force. Figure 4 shows another embodiment of a wound closure tag 200 similar to the tag 100. The wound closure tag 200 has an anchor 210 in the form of a crossbar, a body 220 which is an elongated shaft or strand, and a spring member 230. The spring member 230 is coplanar with the anchor 210 and is in the shape of a semicircle curved toward the anchor 210. The spring member 230 has two arms 232a, 232b, each of which extends radially outward from the body 220 to form the semicircular shape of the spring member 230. The distal end of each arm has a sphere 234 which can rest against an outer tissue surface on a first side of the wound when deployed, and the arms 232a, 232b extend above the outer tissue surface and can be compressed toward the outer tissue surface when a tensile closure force is required to close the wound. Thus, the curved shape of the arms 232a, 232b forming the spring member 230 can provide additional bending or tensile resistance to movement of the tag 200 as it 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] 5 shows a wound closure tag 250, similar to tag 200, including an anchor 260, a spring member 280, and a body 270 extending therebetween. The spring member 280 is a semi-circular member, similar to spring member 230, but lies in a plane perpendicular to the plane of the anchor 260 rather than in the same plane.
[0022] Each of the spring members 230, 280 has two arms, although 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 of which has a first end that engages the body and a second end that has a sphere 334 and is positioned proximate to the anchor 310. The sphere 334 can rest against an outer tissue surface on a first side of the wound upon deployment, and the hemispherical shape of the spring member 330 can provide additional bending or tension resistance to movement of the tag 300, which can also generate additional tension closure forces applied to both sides of the wound.
[0023] 7 shows a wound closure tag 350 similar to tag 300, including an anchor 360, a spring member 380, and a body 370 extending therebetween. The spring member 380 is a hemispherical member similar to spring member 330, but has four arms 382a, 382b, 382c, 382d that curve toward the anchor 360 and define a generally hemispherical shape. Two arms 382b, 382d are coplanar with 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, including aligning the arms with the anchor at various non-perpendicular angles.
[0024] 8 shows another embodiment of a wound closure tag 400 similar to tags 300 and 350. Wound closure tag 400 has an anchor 410, a spring member 430, and a body 420 extending therebetween. Spring member 430 has four arms 432a, 432b, 432c, 432d, each having a first end that engages body 420 and a second or distal end that engages ring 440. Ring 440 extends co-radially around body 420 and engages all of arms 432a, 432b, 432c, 432d such that ring 440 and arms 432a, 432b, 432c, 432d define a hemispherical shape that surrounds a portion of body 420 within the defined hemisphere. When the tag 400 is delivered from the first side 452 to the second side 454 of the wound 450, the ring 440 contacts the outer tissue surface 458 of the first side 452, providing a large and stable contact surface for the spring member 430 against the outer tissue surface 458, as shown in Figures 9 and 10. The arms 432a, 432b, 432c, 432d, when in a compressed state upon initial delivery, can flex and bend to help the tag 400 apply a tensile closure force between the two sides 452, 454 of the wound 450 by exerting an upward pulling force on the body 420. For example, the arms 432a, 432b, 432c, 432d can be compressed toward the outer tissue surface 458 upon initial delivery as the tag 400 acts to close the wound 450, as shown in Figure 9. In this manner, the hemispherical shape of the spring member 430 may be flattened and distorted toward the outer tissue surface 458 upon delivery such that the radius R1 of the hemispherical shape is smaller than when the spring member 430 is in a resting or pre-deployed state. Once the wound 150 is closed, the arms 432a, 432b, 432c, 432d may return to a less distorted hemispherical orientation and the radius R1 of the hemispherical shape may be increased to a value more equivalent to the radius when the spring member 430 is in a resting state as less tensile closure force is required to help the tag 400 draw the two sides 452, 454 of the wound together, as shown in FIG.
[0025] 11A-11C show another embodiment of a wound closure tag 500 similar to tags 200 and 250. Wound closure tag 500 has an anchor 510, a spring member 530, and a body 520 extending therebetween. Spring member 530 is in the shape of a semicircular plate extending towards anchor 510. It has two plate arms or sides 532a, 532b, each of which has one end engaging body 520 and an opposite end extending towards anchor 510. Arms 532a, 532b extend away from body 520 to form the wide semicircular plate shape of spring member 530, generally forming a partial cylindrical shape, with body 520 extending from an inner surface within a semicircular curve of the partial cylinder. Each arm 532a, 532b terminates in a cylindrical bar 534 that extends along an edge of each arm 532a, 532b positioned near the anchor 510. The plate arms 532a, 532b extend flush with the anchor 510 away from the body 520. However, various other alignments of the plate arms 532a, 532b are possible, e.g., the arms 532a, 532b being perpendicular to the anchor 510 and / or the arms 532a, 532b being aligned at various non-perpendicular angles with respect to the anchor. When the tag 500 is delivered to the wound and extends from the first side to the second side of the wound, the cylindrical bar 534, similar to the ring 440 of the tag 400, contacts the outer tissue surface of the first side of the wound to provide a stable contact surface between the spring member 530 and the tissue. As the tag 500 applies a tensile closure force to the wound, the arms 532a, 532b can flex and bend to help apply a greater force, similar to arms 432a, 432b, 432c, 432d. Because the spring member 530 has wide arms 532a, 532b, the force applied is greater than that applied by thin arms, such as those on the 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 therefore the mechanical properties of the spring member 530, such as changing the elastic modulus of the spring member 530.In yet other embodiments, the force of spring member 530 can be adjusted by changing the geometry of spring member 530, for example, by forming spring member 530 into a semi-elliptical shape or a flexible flat plate, thereby varying the depth and adjustable length of body 520 and / or spring member 530 between cylinder 534 and anchor 510.
[0026] 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 shovel and has two lobes 632a, 632b each extending toward the anchor 610, forming a point 634 at the opposite end of the anchor 610. However, the spring member 630 may be rounded at the opposite end of the anchor 610. The ends of the lobes 632a, 632b closest to the anchor 510 rest against the outer tissue surface on the first side of the wound upon deployment, and the lobes 632a, 632b may each provide an additional bending or tensile closure force to the anchor 600.
[0027] Many other designs for the spring members can also be used. For example, Figures 13A-13I and 14A-14I show various additional wound closure tags having a variety of different spring members. Figures 13A-13I show each wound closure tag as viewed from the corresponding spring member toward the corresponding anchor, and Figures 14A-14I show each wound closure tag as viewed from the side. For example, Figures 13A and 14A show a wound closure tag 700 that includes an anchor 702, a body 704, and a spring member 706 shaped like a coil spring or helix that is wrapped around the end of the body 704 opposite the anchor 702 and bulges along a central portion. 13B and 14B show wound closure tag 710 comprising an anchor 712, a body 714, and a spring member 716 shaped like a coiled or spiral cone with the tip of the cone facing away from the anchor 712 and a wider base facing the anchor 712. Figures 13C and 14C show wound closure tag 720 comprising an anchor 722, a body 724, and a spring member 726 shaped like the wire frame of a cone with the spiral tip of the cone facing away from the anchor 722 and a wider base facing the anchor 722. 13D and 14D show wound closure tag 730, which includes anchor 732, body 734, and spring member 736 shaped like a cone with solid panels on the sides and the tip of the cone pointing away from anchor 732 with a wider base facing anchor 732. FIGs. 13E and 14E show wound closure tag 740, which includes anchor 742, body 744, and spring member 746 similar to tag 350 but with arms that are angularly offset from anchor 742. FIGs. 13F and 14F show wound closure tag 750, which includes anchor 752, body 754, and spring member 756, which is a cylinder made from a variety of materials such as hydrogels, elastomers, thermoplastics, partially resorbable materials, foams, nitinol, various polymers, etc. Spring member 756 may also be expandable during use.13G and 14G show a wound closure tag 760 comprising an anchor 762, a body 764, and a spring member 766 that is an amorphous or expandable material such as biological tissue, hydrogel, alginate, etc. FIGs. 13H and 14H show a wound closure tag 770 comprising an anchor 772, a body 774, and a spring member 776 that includes a plurality of unordered arms protruding from an end of the body 774 opposite the anchor 772, resulting in the appearance of a mop or feather duster. FIGs. 13I and 14I show a wound closure tag 780 comprising an anchor 782, a body 784, and a spring member 786 in the shape of a cylinder disposed perpendicular to the body 784. The body 784 is capable of slidable translation perpendicular to the centerline of the spring member 786. The cylindrical body of spring member 786 may be folded, away from anchor 782, with the exterior or interior surface of spring member 786 attached to body 784. All of these spring members may be folded during deployment, for example, with expandable foam, frills, memory retaining materials such as Nitinol, etc. that are held in a compressed tension state until deployment, they may be freeze-dried to allow for deployment before beginning to expand, for example, frozen hydrogels that begin to expand once in contact with heat and / or moisture.
[0028] The anchors can also be collapsible during deployment and expandable once delivered. For example, Figures 15A and 15B show a wound closure tag 790 that includes an anchor 792, a body 794, and a spring member 796 with arms similar to the tag 200. The anchor 792 has a freeze-dried hydrogel 792a attached to it. During deployment as shown in Figure 15A, the anchor 792 is in an unexpanded state because the hydrogel 792a does not have enough time 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 heat and / or moisture in the body.
[0029] The various anchors on the wound closure tags described above 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 puncturing both sides of the wound, threads the anchors of the wound closure tag therethrough, allowing the anchors to travel through the first and second sides and exit the tissue on the second side to anchor themselves therein. The needle also helps guide the body of the wound closure tag during anchor placement, so that the body can extend through the first and second sides of the wound between the spring member of the wound closure tag located on the first side of the wound and the anchor.
[0030] 16A-16C show an embodiment of a delivery needle 800 having a curved distal portion 800d, a channel 802 extending at least partially along the delivery needle, an ejection port 804 positioned at the distal end of the channel 802, a sharpened 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 the anchors may slide along the channel 802 during delivery, and has a slot 803 on the exterior of the needle 800 that forms an opening or passageway from the channel 802 along which the body may slide during delivery. An ejection port 804 at the distal end of the channel 802 allows the anchors to be ejected from the delivery device. In some embodiments, the channel 802 has an upward slope 802a at its distal end approaching the ejection port 804, as shown in FIG. 16C, from which the anchor can exit, with the black bar showing the general path of the bottom of the channel 802 including the upward slope 802a. The distal tip 806 can be formed from various types of needle tips, such as cutting and / or trocar-tip needles with wide solid penetrating sides. In FIG. 16C, an exemplary loading process is shown using a wound closure tag 100, with the internal interactions shown by dashed lines, although any wound closure tag can be used. The needle 800 can load the anchor into the needle by threading the anchor 110 into the ejection port 804 and sliding the anchor 110 proximally along the channel 802, with the body 120 extending from the anchor 110 through the slot 803, and the spring member 130 coupled to the body 120 and positioned outside the needle 800. An open proximal end 808 of needle 800 can receive a flexible push rod 810 therein such that the push rod can push the anchor distally toward distal tip 806 and ejection port 804 during delivery of the anchor to a wound site. As flexible push rod 810 extends through channel 802, needle 800 can push anchor 110 out of ejection port 804 as anchor 110 slides along slope 802a of channel 802.
[0031] The needle 800 can be made from a variety of materials such as medical grade metals, e.g., steel, various hard plastics or polymers, etc., and a variety of push rods can be used in the form of an elongated shaft, as well as 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, once the anchor 110 is proximally loaded into the needle 800, the needle can be passed through tissue at the wound. As shown in FIG. 17A, a surgeon can grasp a first side 902 of the wound 900 in the patient's tissue 910 using various tools, such as forceps 914. The distal tip 806 of the needle 800 can then be passed through the tissue of the first side 902 of the wound 900. The needle 800 shown in FIGS. 17A-17C is disposed on a handle 916, however, the needle 800 can be disposed on or incorporated into various devices, as described below. The second side 904 of the wound 900 can then be grasped, as shown in FIG. 17B, and the distal tip 806 of the needle 800 can be passed through the second side, as shown in FIG. 17C. Thus, the needle 800 can extend across the wound 900 with a proximal side of the needle 800 on a first side 902 of the wound 900 and a distal side of the needle 800 on a second side 904 of the wound 900. The distal tip 806 can extend out of the second side 904 such that the channel 802 can form a passage or pathway through the wound 900. The distal portion of the needle is curved so that the pathway is semicircular.
[0033] The open proximal end 808 of the needle 800 can receive a flexible push rod 810 therein, and the anchor 110 can be pushed distally toward the distal tip 806 and the ejection port 804 as the push rod 810 advances distally. The push rod 810 can be manually inserted and advanced by the surgeon or actuated through various mechanisms described below. Once the flexible push rod 810 extends through the channel 802, the needle 800 can push the anchor 110 out of the ejection port 804 as the anchor slides along the slope 802a of the channel 802, thus placing the anchor 110 on the second side 904 of the wound 900, with the body 120 extending through two 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 may be passed through both sides of the wound simultaneously and / or forceps or other grasping instruments may not be required, depending on the surgeon's comfort level and / or how severe or open the wound is.
[0034] The loading of one or more anchors into the needle and the mechanism for actuating the push rod to pass the anchors therethrough may vary as described below, however, in the following embodiments, the basic process of passing a needle through each side of the wound and advancing a push rod distally along the needle's channel to deliver an anchor of the wound closure tag through the channel and across the wound is used to provide for delivery of the anchor and placement of the wound closure tag across the wound.
[0035] Needle 800 is manually loaded through ejection port 804, although different loading mechanisms are possible. For example, FIGS. 18A and 18B show an embodiment of a delivery needle 850 that can be loaded from the proximal end to allow for delivery of multiple anchors without the need to interact with the distal end of the needle. Proximal loading can allow for easier loading, including automatic loading as described below, and can avoid the hassle and accidental user sticks caused by loading through the ejection port. Needle 850 is a curved needle similar to needle 800, which includes a channel 852 along which a slot 853 extends, an ejection port 854 positioned at the distal end of channel 852, a sharp distal tip 856, and an open proximal end 858. Channel 852 extends from open proximal end 858 to ejection port 854. Thus, needle 850 can be loaded from proximal open end 858.
[0036] An exemplary loading process is shown in FIG. 18A using wound closure tag 500, although any wound closure tag can be used. As shown, needle 850 can receive anchor 510 in channel 852 through proximal open end 858, with body 520 extending through channel 852 and sliding along the channel as anchor 510 moves. Spring member 530 extends from body 510 and remains external to the needle. After distal tip 856 passes through the two sides of the wound, proximal open end 858 of needle 850 can receive flexible push rod 860 that extends distally along channel 852 to push anchor 510 distally through channel 852, as shown in FIG. 18B with dashed lines representing internal engagement. Needle 850 can push anchor 510 out of ejection port 854. Similar to channel 802 of needle 800, channel 852 provides a path along which anchor 510 can travel to move the anchor from a first side to a second side of a wound, with body 520 extending through slot 853 and following behind anchor 510 and spring member 530 remaining on the first side. Anchor 510 is described as being loaded into proximal open end 858 of needle 850. However, anchor 510, similar to needle 800, can be loaded through ejection port 854 if desired.
[0037] As mentioned above, the needle 850 may be manually loaded by the surgeon inserting an anchor into the needle 850, or may be automatically loaded by using various delivery devices, as described below. FIGS. 19A-19J show one embodiment of a delivery device 1000 for delivering wound closure tags. The delivery device 1000 may 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 may also have a removable and replaceable wound closure tag cartridge, which allows the surgeon to deliver multiple wound closure tags during a single procedure and / or allows the surgeon to easily use different types of wound closure tags during a single procedure by simply changing the cartridge. In general, the device 1000 has a housing 1002, a curved needle 1010, an actuation mechanism with a trigger 1020, and a cartridge 1040.
[0038] The housing 1002 is a generally rectangular body that slopes or curves downward from a proximal end 1002p to a 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 the cartridge 1040 therein and hold the cartridge 1040 in rotatable engagement through various mechanisms such as a combination of clips, protrusions and detents, etc. The housing 1002 also has a body slot 1006, described below, 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, although any wound closure tag can be used. The housing 1002 may be designed and shaped to be held similarly to a needle driver to help the surgeon quickly understand how to use the device, for example, by being held in a supination orientation as shown in FIG. 19H, a neutral orientation as shown in FIG. 191, or a pronation orientation as shown in FIG. 19J.
[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 sharpened distal point 1012, an ejection port 1014, an open proximal end 1016, and a channel 1018 extending between the two. The needle 1010 can be advanced through first and second sides of a wound to deliver an anchor 510 of the wound closure tag 500 across the wound. The anchor 510 can be loaded from the open proximal end 1016 of the needle 1010, which is aligned with the cartridge 1040.
[0040] The cartridge 1040 houses a plurality of wound closure tags 500 therein. The cartridge 1040 can automatically load the wound closure tags 500 into the needle 1010 upon actuation of the device 1000 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 and rotated relative to the cartridge opening 1004, similar to the rotatable bullet cylinder of a revolver gun, although other configurations are possible, such as top-loading or side-loading cartridges, as discussed below. The 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 the distal side 1040d to the proximal side 1040p. Each of the tag openings 1042 is sized and shaped to removably receive a selected wound closure tag, such as the illustrated tag 500. Each tag opening 1042 receives an anchor 510 in an anchor cavity 1042a that is offset from and adjacent to the central longitudinal axis A1 of the cartridge 1040. Each anchor cavity 1042a is positioned to align with the open proximal end 1016 of the needle 1010 upon rotation of the cartridge 1040. Each opening 1042 also has a body cavity 1042b that extends radially outward from the anchor cavity 1042a, away from the central longitudinal axis A1 of the cartridge 1040, for receiving a body 520 of a tag 500. The body cavity 1042b terminates in a spring member cavity 1042c disposed radially furthest from the central longitudinal axis A1 of the cartridge 1040, which receives a spring member 530 therein, such that the cartridge 1040 is configured to receive a plurality of tags 500 that fan out from the central longitudinal axis A1.The cartridge 1040 can align one of the anchor cavities 1042a with the open proximal end 1016 of the needle 1010 and can receive a push rod 1030 from the proximal side 1040p and through the anchor cavity 1042a such that any anchors 510 contained therein are urged distally into the open proximal end 1016 of the needle 1010, thus loading the anchors 510 into the needle 1010 and moving the associated wound closure tag 500 distally from the cartridge 1040 perpendicular to the central longitudinal axis A1. The anchor cavities 1042a can receive the push rod 1030 therethrough when the tag 500 is delivered to a 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 central longitudinal axis A1 to align the next anchor cavity 1042a with the open proximal end 1016 of the needle 1010 for the 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 actuation mechanism used to deliver one or more wound closure tags 500 from the cartridge 1040 along the needle 1010 and across the wound. The illustrated actuation 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 coupled to the housing at a pivot point 1020p. The trigger 1020 is coupled to the lever 1022 by a slot 1020a formed in the trigger that allows the lever 1022 to slide along the slot upon actuation of the trigger 1020 by pivoting the trigger 1020 toward the housing 1002. The trigger 1020 has a stop member 1020b that contacts the housing 1002 upon full actuation, stopping the movement of the trigger 1020. The lever 1022 is pivotally coupled to a first gear 1024 and a second gear 1026 on the opposite side of the trigger 1020 at a pivot point 1022p. The first gear 1024 and the second gear 1026 are coupled to the housing 1002 at pivot points 1024p, 1026p. When the trigger 1020 is actuated, the lever 1022 moves slightly proximally toward the housing 1002, causing the lever 1022 to rotate the gears 1024, 1026 about the pivot points 1024p, 1026p, which in turn rotate the gears 1024, 1026 toward the distal end 1002d of the housing 1002. The gears 1024, 1026 have teeth extending therefrom which engage corresponding openings in a rack 1032, which is an elongated member that extends within a slot from the proximal end 1002p toward the distal end 1002d of the housing 1002 and is distally slidable therein. The rack 1032 has a push rod 1030 secured to and extending therefrom at its distal end and has an alignment member 1034 at its distal end. As the gears 1024, 1026 rotate toward the distal end 1002d of the housing 1002, the gear teeth urge the rack 1032 distally, which in turn urges the push rod 1030 distally.When the cartridge 1040 is aligned with the push rod 1030 and needle 1010, the push rod 1030 passes through the aligned anchor cavity 1042a of the cartridge 1040, through the open proximal end 1016 of the needle 1010, and into 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. Upon 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 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 and sits within an alignment slot 1008 within the housing 1002 that terminates at a distal point of full actuation to keep the rack 1032 and the push rod 1030 aligned during movement and to prevent over-actuation. The push rod 1030 may also be a single flexible structure or may have a flexible portion 1030a that slidably moves through a friction reducing guide 1030b as shown in FIG. 19D. Additionally, one or more springs may be provided within the housing to provide tactile feedback upon actuation and / or to slow the movement of the mechanism within the housing. For example, a spring may be provided on the lever 1022 to provide tactile feedback and bias the device 1000 to a non-actuated state. A spring may also be provided around the alignment member 1034 to slow the return of the rack 1032 after actuation.
[0042] Thus, in use, a 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 with the distal tip 1012 protruding 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 push rod 1030. The push rod 1030 can extend distally through the cartridge 1040 and move the anchor 510 of the tag 500 through the open proximal end 1016 of the needle 1010 and into the channel 1018. The push rod 1030 can continue to advance distally through the channel 1018 until the anchor 510 of the tag 500 exits the ejection port 1014 and is delivered to the second side of the wound, thereby delivering the tag 500 similar to the process described above. During the movement of the anchor 510, the body 520 and the spring member 530 advance distally from the cartridge 1040. The body 520 follows the anchor 510 through the body slot 1006 of the housing 1002 and along the channel 1018 of the needle 1010. Once the anchor 510 has passed through the channel 1018 and exited the ejection port 1014 and is positioned on the second side of the wound, the body 520 follows the anchor 510 through the wound and extends from the second side to the first side, with the spring member 530 resting against the first side of the wound after being pulled away from the cartridge 1040.
[0043] The cartridge 1040 is configured to rotate automatically and is automatically aligned with the needle 1010. However, in various other embodiments, the cartridge may be rotated and / or aligned manually, and various mechanisms may be incorporated into the cartridge, the housing 1002, or some combination of the two to aid in automatic and / or manual alignment and rotation. For example, markings on the cartridge and / or housing, ratchet mechanisms, spring and pin pairs, protrusions, detents, notches, holes, etc. may all be used. For example, FIG. 19K shows a cartridge 2040 similar to cartridge 1040, but having a number of angled notches 2042 along its proximal side 2040p. The angled notches 2042 receive pins 2044 disposed in a housing (not shown) similar to housing 1002, and the pins 2044 are biased into engagement with the cartridge 2040 by springs 2046. The angled notch 2042 is angled such that counterclockwise rotation of the cartridge 2040 (as viewed facing the proximal side 2040p) causes the pin 2044 to pop out of engagement with the first notch 2042 and travel along the proximal side 2040p until it reaches the second notch 2042, at which point the pin 2044 engages the second notch 2042. This action ensures alignment of the cartridge 2040 and may also provide an audible click or pop upon alignment. The pin 2044 may also resist clockwise rotation to ensure that the surgeon continues to rotate into the aligned position with the wound closure tags loaded until all wound closure tags have been delivered. However, other engagements are possible and mechanisms may be incorporated into the device 1000 to automatically advance the cartridge 1040. For example, one or more pawls may be attached to the trigger 10220, lever 1022, gears 1024, 1026, etc. to engage a ratchet to rotate the cartridge to the next undelivered tag 500, and another pawl may be placed in a small recess on the cartridge 1040 to stop the cartridge 1040 in a particular position, aligning with the needle 1010 and push rod 1030, similar to the rotatable bullet cylinder of a revolver firearm.
[0044] Although the delivery device 10000 is described above with a rotating cartridge 1040, a variety of 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 show another embodiment of a delivery device 3000 similar to the delivery device 1000, but with a top loading wound closure tag. The device 3000 has a housing 3002, a curved needle 3010, an actuation mechanism with a trigger 3020, and a receiving port 3040 for seating multiple wound closure tags. The housing 3002 is in the shape of a handgun with a pistol grip 3002a, with the needle 3010 protruding distally therefrom. The housing 3002 has a body slot 3006 (similar to the body slot 1006) through its side, along which the body of the wound closure tag passes while a corresponding anchor is delivered through the needle 3010. 20A and 20B show multiple wound closure tags 100, however any wound closure tag can be used. The needle 3010 is configured similar to needle 1010 and is loaded through a proximal open end (not shown) in the housing 3002, the needle having a channel aligned with the receiving port 3040. The trigger 3020 of the actuation mechanism is similar to trigger 1020 and engages a pistol grip 3002a of the housing 3002, and actuation of the trigger 3020 by pivoting the trigger 3020 towards the pistol grip 3002a can be accomplished while holding the device 3000 with the pistol grip 3002a. Similar to the actuation mechanism of device 1000, actuation of trigger 3020 causes rotation of one or more gears (not shown) within housing 3002, driving a rack (not shown) distally and advancing a push rod (not shown) distally along a slot aligned with the bottom of receiving port 3040 and the proximal open end of needle 3010.
[0045] The receiving port 3040 is shaped to receive multiple wound closure tags 100 all arranged in series along the tag spine 3045 such that each anchor 110 of each tag 100 is frangibly connected to the tag spine 3045. The bottom of the receiving port in 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. It therefore acts as an alignment surface to receive the next anchor 110 to be delivered. The receiving port 3040 has an anchor receiving channel 3040a which receives multiple anchors 110 connected to the spine 3045 vertically through the top of the housing 3002 such that the anchors 110 are all aligned to be loaded distally into the proximal open end of the needle 3010 as each anchor reaches the bottom of the receiving port 3040. The receiving port 3040 also has a body channel 3040b that extends between the anchor receiving channel 3040a and the body slot 1006 on the housing 3002, and the plurality of bodies 120 connected to the corresponding plurality of anchors 110 loaded on the device 3000 can move vertically downward along the body channel 3040b as the anchors 110 and spines 3045 move downward, and then each body 120 can move distally along the body slot 3006 with the corresponding anchor 110 as it is delivered through the needle 3010. The 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 within the housing adjacent to the anchor receiving channel 3040a and can optionally extend entirely therethrough. 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 was housing the anchor 110 that had already been delivered, has room to continue moving downward, allowing the next anchor 110 to be delivered to remain precisely aligned with the push rod and needle 3010 on the bottom of the receiving port 3040 without interference from the spine 3045.
[0046] In use, the spine 3045 with multiple wound closure tags 100 frangibly attached thereto can be loaded into the receiving port 3040 with the anchor 110 vertically aligned in the anchor channel 3040a and the body 120 vertically aligned in the body channel 3040b. The wound closure tag 100 leading along the spine 3045 can rest at the bottom of the receiving port 3040. The tag 100 can be aligned with a push rod aligned proximally behind the anchor 110 and aligned with an open end of the needle 3010 aligned distally in front of the anchor 110. As described above, after the needle 3010 has been threaded through both sides of the wound, the trigger 3020 can be actuated to deliver the tag 100. When the trigger 3020 is actuated, gears and racks within the housing drive the push rod distally, similar to the device 1000, causing the push rod to thread through the bottom of the receiving port 3040. As the push rod passes through the receiving port, it contacts the proximal end of the first anchor 110 along the spine 3045 and pushes it distally into the proximal open end of the needle 3010. The distal force of the push rod snaps, severs or breaks the first anchor 110 away from the spine 3045 and the first anchor 110 is pushed distally through the needle 3010 and delivered to the second side of the wound, similar to device 1000. As the first anchor 110 is pushed distally, the first body 120 follows behind the anchor 110 along the body slot 3006 in the housing 3002 and the first spring member 130 is pulled distally along with the body 120 but remains on the first side of the wound. When the trigger 3020 is released, the actuation process is reversed, retracting the push rod proximally from the needle 3010 and receiving port 3040. As the push rod is retracted proximally from the receiving port 3040, the second anchor 110 of the second tag 100 lined up along the spine 3045 can drop into place at the bottom of the receiving port 3040 in preparation for a repeated actuation process, with the push rod destroying or snapping off the second anchor 110 from the spine 3045 during delivery.However, in other embodiments, various other tag advancement mechanisms are capable of moving the next tag 100 into alignment for delivery, for example, a spring member within the housing can apply downward pressure to the spine or can be engaged from below the spine to pull the spine downward, a ratchet and / or gear mechanism is disposed within the housing that is actuated upon each pull of the trigger to move the spine downward a corresponding distance to align the next anchor, multiple tags 100 and spines 3045 can be loaded into a top-loading vertical cartridge that contains 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, multiple 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 delivery device 3000. Device 4000 has a housing 4002, a curved needle 4010, an actuation mechanism with a trigger 4020, and a receiving port 4040 for receiving multiple wound closure tags. Housing 4002 is in the shape of a handgun with a proximally angled pistol grip 4002a, and needle 4010 protruding distally therefrom. Housing 4002 has a body slot 4006 similar to body slot 4006, along which the body of the wound closure tag passes while a corresponding anchor is delivered through needle 4010. However, body slot 4006 is on the top surface of housing 4002 instead of the side. Although FIGS. 21-23 show multiple wound closure tags 350, any wound closure tag can be used. The needle 4010 is configured similarly to the needle 3010 and is loaded through a proximal open end (not shown) in the housing 4002 and has a channel aligned with the receiving port 4040. The trigger 4020 of the actuation mechanism is similar to the trigger 3020 and engages the pistol grip 4002a of the housing 4002, such that actuation of the trigger 4020 by pivoting the trigger 4020 towards the pistol grip 4002a can be accomplished while holding the device 4000 with the pistol grip 4002a. Similar to the actuation mechanism of the device 3000, actuation of the trigger 4020 causes rotation of one or more gears (not shown) within the housing 4002, driving a rack (not shown) distally to advance a push rod (not shown) distally along a slot aligned with the bottom of the receiving port 4040 and the proximal open end of the needle 4010.
[0048] The receiving port 4040 is shaped to receive multiple wound closure tags 350 all arranged in series along the tag spine 4045 such that each anchor 360 of each tag 350 is frangibly connected 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, as does the bottom of the receiving port 3040 in the housing 3002, which is aligned at its distal end with the proximal open end of the needle 4010 and at its proximal end with the push rod. The receiving port 4040 also has an anchor receiving channel (not shown) which receives multiple anchors 360 connected to the spine 4045 horizontally through the side of the housing 4002 such that when each anchor 360 reaches the distal end of the receiving port 4040, the anchors 360 are all aligned to be distally loaded into the proximal open end of the needle 4010. The receiving port 4040 also 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 a 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 along with their corresponding anchors 360 as they are 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 in the housing and can optionally extend completely through it. The spine channel receives the spine 4045 therealong and extends horizontally beyond the distal end of the receiving port 4040. Thus, the first portion of the spine 4045, which contained the already delivered anchor 360, has room to continue moving horizontally, allowing the next anchor 360 to be delivered to remain precisely aligned with the push rod and needle 4010 at the end of the receiving port 4040 without interference from the spine 4045.
[0049] The receiving port 4040 is aligned with a tab housing 4042 that includes 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 of the housing that is aligned with the receiving port 4040. The retaining portion 4042a is a generally rectangular object that receives the multiple tags 350 and spines 4045 therein during use and provides protection to the multiple anchors 350 and spines 4045. The retaining portion 4042a may also have one or more anchor advancement mechanisms therein, such as a spring or rotatable knob at the end opposite the receiving port 4040, that can apply a horizontal force to the spine 4045 to maintain the next tag 350 to be delivered in alignment with the needle 4010 and push rod.
[0050] In use, the device 4000 operates similarly to the device 3000. A spine 4045 having multiple wound closure tags 350 frangibly attached thereto can be loaded into the receiving port 4040, and the tab housing 4042 can be secured to the device housing 4002. A first wound closure tag 350 leading along the spine 4045 can be stopped at the distal end of the receiving port 4040 in alignment with the push rod proximally behind the first anchor 360 in the row, and distally in alignment with the proximal open end of the needle 4010 in front of the first anchor 360. After the needle 4010 has been threaded through both sides of the wound, the 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, threading it through the distal end of the receiving port 4040. In this manner, the push rod breaks off the first anchor 360 from the spine 4045 and pushes it distally into the proximal open end of the needle 4010. The anchor 360 is urged distally through the channel of the needle 4010 and delivered to the second side of the wound with the body 370 extending across the wound and the spring member 380 remaining on the first side. When the trigger 4020 is released, the actuation process is reversed, causing the push rod to retract proximally from the needle 4010 and the receiving port 4040. As the push rod is retracted proximally from the receiving port 4040, the second anchors 360 of the second tags 350 aligned along the spine 4045 can move horizontally into position. As described above, such movement can occur by a spring or a rotatable knob in the retaining portion 4042a exerting a horizontal force on the spine 4045. However, in other embodiments, other mechanisms are possible, such as a spring member within the housing, a ratchet and / or gear mechanism can be disposed within the housing that is actuated upon each pull of the trigger, the spine 4045 can be moved manually, etc.
[0051] 22 shows another embodiment of a delivery device 5000 similar to device 4000, but with a side-loading mechanism. Device 5000 has a housing 5002, a curved needle 5010, an actuation mechanism with a trigger (not shown), a receiving port 5040 for a plurality of wound closure tags, and a body slot 5006. However, device 5000 does not have a tab housing 4042 thereon. A spine channel 5040c, similar to the spine channel of device 4000, extends generally horizontally through device 5000 and opens on the opposite side to the receiving port 5040. Spine channel 5040c receives a spine 4045 coupled to a plurality of tags 350 therethrough, such that a first portion of spine 4045, whose anchor 360 has already been detached, can extend horizontally away from device 5000 during use.
[0052] Devices 3000, 4000, 5000 have wound closure tags loaded perpendicular to the movement of the corresponding push rod. However, multiple 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 portion of another embodiment of a delivery device for wound closure tags similar to devices 3000, 4000, and 5000 described above. However, instead of having a side or top loading mechanism, the loading and delivery portion shown in FIGS. 24A-24C has two channels running parallel to each other: a push rod channel 6002 and a wound closure tag channel 6004. The push rod channel 6002 receives a push rod 6010 therethrough upon actuation of the device, and the wound closure tag channel 6004 receives multiple wound closure tags 500 frangibly connected in a straight line on a geared spine 6020 therethrough. Although the tag 500 is shown in Figures 24A-24D, any wound closure tag can be used, such as the wound closure tag 600 on the spine 6030 of Figure 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 therein a corresponding spine 6020, anchor 510, body 520, and spring member 530 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 run side-by-side within the housing of the device from the proximal portion of the device to the distal end, in parallel directions, as shown in Figures 24B and 24C. However, as highlighted by the black bar in Figure 24C, the wound closure tag channel 6004 transitions into alignment with and merges with the push rod channel 6002 at a point proximal to the needle of the device but distal to the push rod 6010 itself.Thus, the wound closure tag channel 6004 effectively terminates within the push rod channel 6002. At the point where the wound closure tag channel 6004 joins the push rod channel 6002, the spine 6020 advances distally and the anchor 510 of the next tag 500 delivered in sequence advances into the joining portion of the push rod channel 6002 proximal to the needle and distal to the push rod 6010, while any subsequent tag 500 remains slightly proximal to the joining point at the wound closure tag channel 6004. Thus, the anchor 510 of the next tag 500 delivered rests solely within the joining portion of the push rod channel 6002, with the body 520 and spring member 530 extending vertically above the joining portion of the push rod channel 6002. Upon actuating the device using any of the mechanisms described above, such as by distal advancement of a rack 6012 coupled to the push rod 6010, the push rod 6010 advances distally through the push rod channel 6002, including the converging portion of the channel where the next tag 500 is positioned. The anchor 510 of the tag 500 to be delivered is snapped, severed, or broken from the spine 6020, and the push rod 6010 pushes the anchor 510 distally into the needle channel and out the distal side for delivery to the second side of the wound. The push rod 6010 is then retracted proximally from the converging portion of the push rod channel 6002, and the spine 6020 is advanced again to load the next tag 500 into the converging portion of the push rod channel 6002. Although the confluence of the push rod channel 6002 has been described herein, the confluence may be the proximal open end of the needle, such that the needle directly couples to the push rod channel 6002 and the wound closure tag channel 6004 at the confluence. The spine 6020 advances distally in a controlled manner by engagement of teeth and gears located along the bottom surface of the spine 6020. The gears may rotate automatically upon actuation of the device. However, various other advancement mechanisms may 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 multiple wound closure tags can be frangibly coupled thereto or directly deployed individually. For example, FIG. 26 shows a delivery device 7000 similar to that described above. 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 actuation mechanism having a push rod 7030. A multiple wound closure tags 430 are provided, which are frangibly coupled to each other by the anchors 410 engaged end-to-end in linear succession. Although a tag 400 is shown here, any wound closure tag can be used. The multiple wound closure tags 400 are loaded into the receiving port 7040 on their proximal ends and deployed distally in succession through the housing 7002 awaiting deployment. The anchors 410 are held within the housing 7002 with the body 420 extending through the housing 7002 and along the receiving port 7040, and the spring member 430 extending 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 into the delivery channel 7042. Thus, the anchor 410 of the corresponding tag 400 is aligned within the delivery channel 7042 distally to the push rod 7030 and proximally to the proximal open end of the needle 7010. Similar to the actuation mechanism described above, when the device 7000 is actuated, the push rod 7030 is driven distally forward through the delivery channel 7042, through the proximal open end, and along the channel of the needle 7010. The push rod 7030 encounters and urges the anchor 410 of the tag 400 distally for delivery, after which the tag's anchor 410 is delivered across the wound to the second side. 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.A variety of different mechanisms can be used to break the delivered tag 400 and move it horizontally into the delivery channel 7042, such as the interaction of a gear and a push member caused by actuation of the device, a spring mechanism, or manual force.
[0054] Some delivery devices may use a mechanical actuation mechanism similar to the devices described above while using manual loading. For example, Figures 27A and 27B show a delivery device 8000 similar to device 1000 for delivering a wound closure tag. Device 8000 has a housing 8002, a curved needle 8010, an actuation mechanism with a trigger 8020, a tag loading port 8040, and a body slot 8006 in housing 8002. An anchor of a wound closure tag, such as one of the wound closure tags described above, is inserted into tag loading port 8040. Within tag loading port 8040, the anchor is aligned at a position proximal to the open end of needle 8010 and distal to the push rod. After needle 8010 passes through two sides of the wound, 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, resulting in delivery of the anchor to the second side of the wound. The corresponding body of the tag follows behind the anchor being delivered, sliding 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 also optionally be loaded through an ejection port on the needle 8010, as described in detail above.
[0055] Although a trigger for actuation is shown and various manual, gravity feed, or spring or rotation mechanisms for the advancement of the wound closure tag are discussed, a variety of different actuation and advancement mechanisms can be used in other embodiments, such as a slider release and / or push button on the housing. A removable cartridge can also be used that contains multiple wound closure tags connected, stacked, and / or arranged in series, which can be clipped into and subsequently released from the device using various clips, slider releases, push buttons, and the like. Additionally, while various spines are shown, other mechanisms for indexing and deploying the wound closure tag can be used, such as frangibly connecting anchors directly together, frangibly connecting spring members directly together, or some combination of the two. The various device embodiments described herein can also generally mimic a needle driver in ergonomic shape, method of use, and overall design to allow the 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-C show a wound 9000 closed using the wound closure tag 100 described above at days 0, 14, and 28, respectively. The wound 9000 shows significant healing with the incision line nearly completely disappearing by day 28. A similar wound 9002 was closed using sutures and FIGS. 29A-C show healing at days 0, 14, and 28, respectively. The wound 9002 has closed by day 28, but the incision line is still visible. Finally, another similar wound 9004 was closed using staples and FIGS. 30A-C show healing at days 0, 14, and 28, respectively. Wound 9004 still shows signs that the incision is in the process of completely closing at day 28. Thus, the wound closure tag provides improved healing compared to sutures and staples.
[0057] Additionally, Figures 31A and 31B show a tensile stress or pull test applied to a suture 9010 used to close a wound in tissue. The suture 9010 caused tears and tears in the skin caused by uneven distribution of force through and across the wound, as seen in Figure 31B. A second tensile stress or pull test was performed on a wound closure tag 9012, similar to the tag 100 described herein, as shown in Figures 32A and 32B. The tag 9012 caused significantly less skin tears and tears caused by a greater distribution of force through the wound, as seen in Figure 32B.
[0058] All of the devices disclosed herein may be designed to be disposed of after a single use, or they may be designed to be used multiple times. In either case, however, the devices may be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular parts, and subsequent reassembly. In particular, the device may be disassembled, and any number of the particular parts or portions of the device may be selectively replaced or removed in any combination. Once particular parts have been cleaned and / or replaced, the device may be reassembled for subsequent use at a reconditioning facility or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device may utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques, and the resulting reconditioned device, are all within the scope of the present 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 soak). The devices, when implanted, are preferably sealed. This can be done by any number of methods known to those of skill in the art.
[0060] Furthermore, in this disclosure, similarly named components of an embodiment generally have similar characteristics, and therefore, within a particular embodiment, each feature of each similarly named component is not necessarily described in full detail. Furthermore, to the extent that linear or circular dimensions are used in describing the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that may be used with such systems, devices, and methods. Those skilled in the art will understand that the equivalent of such linear and circular dimensions for any geometric shape may be readily determined. The size and shape of the systems and devices, and their components, may 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 for which the systems and devices are used, and the methods and procedures for which the systems and devices are used.
[0061] Those skilled in the art will appreciate additional features and advantages of the described apparatus and methods based on the above-described embodiments. Accordingly, the present disclosure is not limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.
[0062] [Embodiment] (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 and connecting the first anchor and the second anchor member, the second anchor being positioned on a second side of the wound and the first anchor member being positioned on a first side of the wound, the wound closure member being configured to close the wound upon application of an eversion force when the body extends through tissue of the wound; a curved delivery needle having a proximal open end, a distal end having an ejection port and terminating in a distal tip, and a channel extending between the proximal open end and the ejection port, the channel configured to slidably receive the anchor; 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 open end of the delivery needle to the ejection port; Including, the system. (2) The system of 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 semicircular panel extending toward the anchor, and a spiral. (3) The system of embodiment 2, wherein the second anchor is configured to apply an adjustable abduction closure force based on the wound and selected movement of the second anchor. (4) The system of embodiment 1, wherein the at least one wound closure member comprises a plurality of wound closure members frangibly connected to one another. (5) The system of embodiment 4, wherein the multiple wound closure members are frangibly connected by spines.
[0063] (6) The system of embodiment 1, further comprising a handle coupled to a proximal end of the delivery needle and configured to receive the push rod therethrough and guide the push rod into the needle, the handle having a trigger configured to slidably move the push rod. (7) The system of 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 from the cartridge along the channel of the delivery needle upon actuation of the push rod. (8) The system of embodiment 1, wherein the channel of the delivery needle has an upward slope terminating at the ejection port. (9) The system of 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; threading a first anchor of a wound closure member through a channel of the needle from the first side to the second side of the wound such that the first anchor exits an ejection port at a distal end of the needle at the second side and engages an exterior surface of the tissue at the second side; retracting the delivery needle to release a second anchor of the wound closure member such that the second anchor engages an exterior surface of the tissue on the first side of the wound; Including, a body coupled between the first anchor and the second anchor extends through the tissue and through the wound; The wound closure member applies an eversion force to the tissue, causing the first and second sides of the tissue to move toward one another, thereby closing the wound.
[0064] 11. The method of claim 10, wherein passing the anchor comprises advancing a push rod along the channel of the needle to advance the anchor through the needle. (12) The method of embodiment 10, further comprising, prior to threading the anchor, advancing the first anchor into a proximal end of the channel of the delivery needle such that the body extends through a slot formed in a sidewall of the needle and the second anchor is positioned exterior to the needle. (13) The method of embodiment 10, wherein threading the first anchor comprises 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 open end to the ejection port, thereby threading and ejecting the first anchor. (14) The method of embodiment 13, further comprising rotating the cartridge to align a third anchor of a second wound closure member with the channel of the needle. (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, a hemispherical structure, a semicircular panel extending toward the anchor, and a spiral; 11. The method of claim 10, wherein retracting the delivery needle to release the second anchor includes the wound closure member applying an adjustable abduction closure force based on movement of the wound and the selected second anchor.
[0065] (16) A system for closing a wound, comprising: at least one wound closure member having a rigid first anchor, a spring member, and a body extending between and connecting the first anchor and the spring member, the spring member configured to apply an adjustable eversion closure force to the wound based on movement of the wound and a shape of the spring member when the spring member is positioned on a second side of the wound and the rigid first anchor member is positioned on a first side of the wound and when the body extends through tissue of the wound; a curved delivery needle having a proximal open end, a distal end having an ejection port and terminating in a distal tip, and a channel extending between the proximal open end and the ejection port, the channel configured to slidably receive the anchor; 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 open end of the delivery needle to the ejection port; Including, the system. (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-flat arms, a plurality of convex or concave arms, a hemispherical structure, a semicircular panel extending toward the anchor, and a spiral. (18) The system of embodiment 17, wherein each selected shape of the spring member is configured to apply a different, adjustable abduction closure force to the wound. (19) The system of embodiment 16, wherein the at least one wound closure member comprises a plurality of wound closure members frangibly connected to one another. (20) The system of embodiment 19, wherein the multiple wound closure members are frangibly connected by spines.
[0066] (21) The system of embodiment 16, further comprising a handle coupled to a proximal end of the delivery needle and configured to receive the push rod therethrough and guide the push rod into the needle, the handle having a trigger configured to slidably move the push rod. (22) The system of embodiment 21, further comprising a removable and replaceable cartridge configured to receive the at least one wound closure member therein and configured to be removably mated 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. (23) The system of embodiment 16, wherein the channel of the delivery needle has an upward slope terminating at the ejection 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, comprising: passing a curved delivery needle through tissue on a first side and a second side of the wound; threading a rigid first anchor of a wound closure member through a channel of the needle from the first side to the second side of the wound such that the rigid first anchor exits an ejection port at a distal end of the needle at the second side and engages an exterior surface of the tissue at the second side; retracting the delivery needle to release a spring member of the wound closure member such that the spring member engages an exterior surface of the tissue on the first side of the wound; Including, a body coupled between the rigid first anchor and the spring member extending through the tissue and through the wound; the spring member applies an adjustable eversion closure force to the tissue to move the first and second sides of the tissue toward one another to close the wound; The adjustable eversion closure force is adjustable based on the movement of the wound and a geometry of the spring member.
[0067] 26. The method of claim 25, wherein passing the anchor comprises advancing a push rod along the channel of the needle to advance the anchor through the needle. (27) The method of embodiment 25, further comprising, prior to threading the anchor, advancing the rigid first anchor into a proximal end of the channel of the delivery needle such that the body extends through a slot formed in a sidewall of the needle and the spring member is positioned exterior to the needle. (28) The method of embodiment 25, wherein threading the rigid first anchor comprises 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 open end to the ejection port, thereby threading and ejecting the rigid first anchor. (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, a convex or concave arm, a hemispherical structure, and a semicircular panel extending toward the anchor, and a spiral; 26. The method of claim 25, wherein each selected shape of the spring member applies a different, adjustable abduction closure force to the wound.
Claims
1. 1. A system for closing a wound, comprising: at least one wound closure member having a rigid first anchor, a spring member, and a body extending between and connecting the rigid first anchor and the spring member, the spring member including a flexible elastomer cooperable with the rigid first anchor and the body to apply an effective tensile closure force between a first side and a second side of the wound, the wound closure member being configured to apply an adjustable eversion closure force to the wound based on movement of the wound and a shape of the spring member when the spring member is positioned on the second side of the wound and the rigid first anchor is positioned on the first side of the wound and the body extends through tissue of the wound; a curved delivery needle having a proximal open end, a distal end having an ejection port and terminating in a distal tip, and a channel extending between the proximal open end and the ejection port, the channel configured to slidably receive the rigid first anchor; a push rod slidably coupled to the curved delivery needle and configured to translate the rigid first anchor of the wound closure member along the channel from the proximal open end of the curved delivery needle to the ejection port; Including, the system.
2. The system of claim 1 , wherein the rigid first anchor is a crossbar.
3. 2. The system of claim 1, wherein the spring member includes at least two arms, each arm having a first and a second end, the first end coupled to the body, and each arm curved from the first end to the second end toward the rigid first anchor.
4. The system of claim 3 , wherein the spring member comprises three of the arms.
5. The system of claim 3 , wherein the second end of each of the arms comprises a sphere.
6. The system of claim 3 , wherein the spring member includes four of the arms and a ring, the second ends of the arms being connected to the ring.
7. 4. The system of claim 3, wherein the spring member includes two of the arms, the two arms being first and second arms, the spring member further including a third and a fourth arm, the third and fourth arms each having a first and second end, the first end of the third arm and the first end of the fourth arm being connected to one another 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.
8. The system of claim 3 , wherein the arm is a plate arm.
9. The system of claim 8 , wherein the plate arm terminates in a cylindrical bar, the cylindrical bar defining the second end.
10. The system of claim 3 , wherein the arm is a panel having a shape that diverges from the first end toward the second end.
11. The system of claim 1 , wherein the at least one wound closure member comprises a plurality of wound closure members frangibly connected to one another.
12. The system of claim 11 , wherein the plurality of wound closure members are frangibly connected by a spine.
13. 10. The system of claim 1, further comprising a handle coupled to a proximal end of the curved delivery needle and configured to receive the push rod therethrough and guide the push rod into the curved delivery needle, the handle having a trigger configured to slidably move the push rod.
14. 14. The system of claim 13, further comprising a removable and replaceable cartridge configured to receive the at least one wound closure member therein and configured to be removably mated to the handle, the at least one wound closure member being translatable from the cartridge along the channel of the curved delivery needle upon actuation of the push rod.
15. The system of claim 1 , wherein the channel of the curved delivery needle has an upward slope that terminates at the ejection port.
16. The system of claim 1 , wherein the distal tip of the curved delivery needle includes a cutting tip.
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