Patent Description:
Wound closure, for example closing lacerations or surgical incisions in skin of a patient, is often accomplished through use of sutures, surgical staples, or medical adhesives. Sutures can be both slow to apply and cause wound inversion, in which dead tissue along a top surface of skin is pushed inward toward the wound, which can slow down healing time and can cause greater scarring. Sutures and staples can lead to scarring and infection, and they can be painful during application. Medical adhesives generally can be ineffective in permanently or substantively closing a wound and are often used as dressing rather than any type of permanent closure mechanism.

<CIT> describes surgical fasteners for use with a handheld device in which the fastener is made up of a filament member terminated at each end by identical rod-shaped anchoring heads. <CIT> describes a fastener having an anchor at each end of a connecting portion and at least one of the anchors is expandable. However, the disclosures fail to describe successful wound eversion closures.

Therefore, improved wound closure techniques are needed.

Methods, devices, and systems are provided herein for implanting a wound closure tag for closing a wound. The invention itself is disclosed in the appended claims.

In one aspect, a system for closing a wound is provided that has at least one wound closure member with a first anchor, a second anchor, and a body extending between and coupling the first anchor and the second anchor. The wound closure member is configured to provide an eversion closure force to a wound when the first anchor is positioned on a first side of the wound, the second anchor is positioned on a second side of the wound, and the body extends through tissue of the wound. The system also has a curved delivery needle with a proximal open end, a distal end that has an ejection port thereon and that terminates in a distal point, and a channel that extends between the proximal open end and the ejection port. The channel is configured to slidably receive the first anchor. The system also has a pushrod that is slidably coupled to the curved delivery needle and configured to translate the first anchor of the wound closure member along the channel from the proximal open end to the ejection port of the delivery needle.

The system can have numerous variations. For example, the first anchor can be a crossbar, and the second anchor can be a spring member selected from a group consisting of a plurality of flat or non-flat arms, a plurality of convex or concave arms, a semi-spherical structure, a semi-circular panel extending toward the anchor, and a spiral. The second anchor can also be configured to apply an adjustable eversion closure force based on movement of the wound and the selected second anchor. In some examples, at least one wound closure member can include a plurality of wound closure members frangibly coupled to one another. The plurality of wound closure members can also be frangibly coupled to by a spine. The system can also include a handle that is coupled to a proximal end of the delivery needle and is configured to receive the push rod therethrough to guide the pushrod into the needle. The handle can have a trigger configured to slidably move the pushrod. In one example, the system can include 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 such that the at least one wound closure member is translatable out of the cartridge and along the channel of the delivery needle upon actuation of the pushrod. The channel of the delivery needle can also have an upward slope terminating at the ejection port. In another example, the distal point of the delivery needle can include a trocar tip.

In another aspect, a method of closing a wound in tissue is provided that includes passing a curved delivery needle through tissue on first and second sides of a wound. It also includes passing a first anchor of a wound closure member through a channel in 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 on the second side and engages an exterior surface of the tissue on the second side. The method further includes retracting the deliver 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. A body coupled between the first anchor and the second anchor extends through the tissue and 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.

The method can have a variety of different embodiments. For example, passing the first anchor can include advancing a pushrod along the channel of the needle to advance the first anchor through the needle. The method can also include, prior to passing the first anchor, advancing the first anchor into a proximal end of the channel in the delivery needle such that the body extends through a slot formed in a sidewall of the needle and the second anchor is positioned external to the needle. Passing the first anchor can also include actuating a trigger coupled to a handle on a proximal end of the delivery needle to advance a pushrod along the channel of the needle from a proximal open end to the ejection port to thereby pass and eject the first anchor. In one example, the method can also include rotating a cartridge to align a third anchor of a second wound closure member with the channel in the needle. In some examples, the first anchor can be a crossbar, and the second anchor can be a spring member selected from a group consisting of a plurality of flat or non-flat arms, convex or concave arms, a semi-spherical structure, a semi-circular panel extending toward the anchor, and a spiral. Furthermore, retracting the deliver needle to release the second anchor can include the wound closure member applying an adjustable eversion closure force based on movement of the wound and the selected second anchor.

The embodiments described above will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings. The drawings are not intended to be drawn to scale. In the drawings:.

Certain exemplary embodiments will now be described to provide an overall 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 understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention as defined by the claims.

Various exemplary methods, devices, and systems are provided for closing wounds, such as lacerations or surgical incisions, using one or more wound closure members. For example, a wound closure member is provided that has an anchor on a distal end thereof, a spring member on a proximal end thereof, and a body extending between the two. The anchor can be configured to be delivered through tissue using a needle delivery device having a curved needle that is penetrated through tissue on first and second sides of a wound. The anchor can engage tissue on the second side of the wound, and the body can trail the anchor during delivery such that it extends between the two sides of the wound. The spring member can remain on the first side of the wound and secure itself against tissue on the first side. It can provide flexibility to the wound closure member such that effective tensile or compressive force is applied to tissue on both sides of the wound to close the wound. As tissue around the wound flexes and moves, the spring member can adjust the applied tensile force to maintain generally corresponding closure force to close the wound that increases or decreases based on movement of the tissue. Additionally, the anchor and body are implanted using a curved needle such that, after implantation, the anchor and the spring member rest against outer surfaces of tissue while the body extends down into tissue in a generally semi-circular shape to connect the anchor and spring member. This generally semi-circular pathway through the wound applies an upward force on tissue along the wound while the wound closure member applies a constantly adjusting closure force, which causes wound eversion or upward puckering of the skin at the wound site. Wound eversion can promote faster healing, better blood flow, and less scarring along the wound, and the wound closure member can also avoid or decrease wound inversion, or strangulation of tissue at the wound site that leads to poor closure and scarring. The wound closure member can also allow for a more rapid closure process.

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

The needle can be incorporated into a variety of different delivery devices, and various activators can be used to pass the anchor of the wound closure member through the channel of the needle and out the ejection port. Various delivery devices can also be used that incorporate one or more wound closure members therein, either loaded manually into the device or configured to be deployed automatically through various cartridge delivery systems discussed below.

<FIG> illustrates one embodiment of a wound closure member in the form of a wound closure tag <NUM>. The wound closure tag <NUM> has an anchor <NUM>, an anchor or spring member <NUM>, and a body <NUM> extending therebetween. The anchor <NUM> is shaped and sized to allow delivery through a curved needle, as discussed below, and across tissue from a first side <NUM> to a second side <NUM> of a wound <NUM> such that it engages and rests against an external tissue surface <NUM> on the second side <NUM> of the wound <NUM>, as illustrated in <FIG>. The body <NUM> trails behind the anchor <NUM> during delivery. Once implanted, it stretches between the first and second sides <NUM>, <NUM> of the wound <NUM> to connect the anchor <NUM> on the second side <NUM> to the spring member <NUM> on the first side <NUM> and forms a generally semi-circular path through tissue. The spring member <NUM> is coupled to the anchor <NUM> through the body <NUM> and is designed to remain on the first side <NUM> of the wound such that it does not pass through tissue. Instead, it engages an external tissue surface <NUM> on the first side <NUM> of the wound <NUM> after delivery and acts to secure the external tissue surface <NUM> on the first side <NUM>. The spring member <NUM> is a flexible, elastic body that flexes and bends as tissue around the wound move, thus allowing the tag <NUM> to apply a constantly adjusting closure force as a patient moves or shifts by allowing the spring member <NUM> to bend or resist movement depending on an amount of patient movement. The anchor <NUM>, the body <NUM>, and the spring member <NUM> thus operate together to apply an effective tensile closing force between the first and second sides <NUM>, <NUM> of the wound <NUM> while not causing significant displacement of the tag <NUM> or significant tearing of tissue. As illustrated by the arrows in <FIG>, the constantly adjusting tensile closing force of the tag <NUM> can be applied to the wound <NUM> along the semi-circular implant path of the body <NUM> that extends below a surface of the wound. As such, it can thus apply closure force that draws the first and seconds sides of the wound together while also applying an upward or pulling force, illustrated by arrows in <FIG>, that can result in wound eversion and better healing results.

In the illustrated embodiment in <FIG>, the wound closure tag <NUM> has an anchor <NUM> in the form of a cross-bar, a body <NUM> in the form of an elongate shaft or strand, and a spring member <NUM> in the form of a crossbar similar to anchor <NUM>, in effect representing a second anchor. As such, anchors and spring members can represent a similar component, and a variety of other second anchors or spring members are possible, as discussed below. The body <NUM> extends perpendicularly between the anchor <NUM> and the spring member <NUM>. The wound closure tag <NUM> is generally I shaped, however a variety of different shapes and orientations are possible for the spring member and/or the anchor, as discussed below. The tag <NUM> can be sized and shaped based on an intended surgical site to create different amounts of tensile closing force applied to the wound. For example, the tensile closing force can be varied by using a different length for the body <NUM> and/or using a different design or different flexibility for the spring member <NUM>. The illustrated body <NUM> has a fixed length, however some bodies can have flexible or adjustable lengths that can be altered during use to allow a customized closure length and/or customized tensile closure force.

The wound closure tag <NUM> can be composed of a variety of materials, such as plastics, metals, medical elastomers, polymers, hydrogels, nitinol, biological tissue, absorbable, non-absorbable, etc., and various parts of the tag <NUM> can be comprised of different materials, such as the spring member <NUM> as discussed below. The tag <NUM> can have a variety of dimensions based on the desired application of the tag <NUM>. However, the body <NUM> can have dimensions of a length of approximately <NUM> to <NUM>, and more preferably approximately <NUM> to <NUM>, and a diameter of approximately <NUM> to <NUM>, and more preferably approximately <NUM> to <NUM>. Additionally, the anchor <NUM> can have a length of approximately <NUM> to <NUM>, and more preferably approximately <NUM> to <NUM>, and a diameter of approximately <NUM> to <NUM>, and more preferably approximately <NUM> to <NUM>. The illustrated spring member <NUM> of <FIG> can have similar dimensions as anchor <NUM>, however the spring member can have a variety of different configurations in different embodiments, as discussed below. The wound closure tag <NUM> can be arranged in the skin of the patient at a variety of depths and distances from the wound <NUM>, for example the anchor <NUM> and the spring member <NUM> can extend through skin of the patient and be positioned approximately <NUM> to <NUM> away from the wound <NUM> on opposite sides thereof.

As noted, numerous different configurations of spring members can be used depending on a desired wound closure application and a desired tensile closing force. <FIG> illustrates another embodiment of a wound closure tag <NUM> similar to tag <NUM>. Wound closure tag <NUM> has an anchor <NUM> in the form of a crossbar, a body <NUM> that is an elongate shaft or a strand, and a spring member <NUM>. The spring member <NUM> is in the shape of a semi-circle that is coplanar with the anchor <NUM> and is curved toward the anchor <NUM>. The spring member <NUM> has two arms 232a, 232b that each extend radially outward from the body <NUM> to form the semi-circular shape of the spring member <NUM>. The terminal end of each arm has a sphere <NUM> that can rest against an outer tissue surface on a first side of a wound upon deployment, and the arms 232a, 232b can extend above the outer tissue surface, compressing toward the outer tissue surface when tensile closing force is required to close the wound. The curved shape of the arms 232a, 232b that form the spring member <NUM> can thus provide additional flex or tensile resistance to movement of the tag <NUM> when the tag <NUM> extends across first and second sides of a wound, which can also increase tensile closing force applied to tissue on both sides of the wound to more securely close the wound.

<FIG> illustrates a wound closure tag <NUM> similar to tag <NUM> with an anchor <NUM>, a spring member <NUM>, and a body <NUM> extending therebetween. The spring member <NUM> is a semi-circular member like the spring member <NUM>, however it is in a plane perpendicular to a plane of the anchor <NUM>, rather than being coplanar with the anchor.

While the spring members <NUM>, <NUM> each have two arms, various numbers of arms can be used and in numerous different configurations. For example, <FIG> illustrates another embodiment of a wound closure tag <NUM> similar to tags <NUM> and <NUM>. The wound closure tag <NUM> has an anchor <NUM>, a spring member <NUM>, and a body <NUM> extending therebetween. In this embodiment, the spring member <NUM> has three arms 332a, 332b, 332c that each has a first end that engages the body and a second end positioned closer to the anchor <NUM> having a sphere <NUM> thereon. The spheres <NUM> can rest against an outer tissue surface on a first side of a wound upon deployment, and the semi-spherical shape of the spring member <NUM> can provide additional flex or tensile resistance to movement of the tag <NUM> when the tag <NUM>, which can also create additional tensile closing force applied to both sides of the wound.

<FIG> illustrates a wound closure tag <NUM> similar to tag <NUM> with an anchor <NUM>, a spring member <NUM>, and a body <NUM> extending therebetween. The spring member <NUM> is a semi-spherical member similar to spring member <NUM>, however it has four arms 382a, 382b, 382c, 382d curving toward the anchor <NUM> and defining a generally semi-spherical shape. Two arms 382b, 382d are coplanar with the anchor <NUM> while the other two arms 382a, 382c are in a plane perpendicular to a plane of the anchor <NUM>. However, various other alignments of the arms are possible, such as having the arms aligned at various non-right angles with the anchor.

<FIG> illustrates another embodiment of a wound closure tag <NUM> similar to tags <NUM> and <NUM>. The wound closure tag <NUM> has an anchor <NUM>, a spring member <NUM>, and a body <NUM> extending therebetween. The spring member <NUM> has four arms 432a, 432b, 432c, 432d that each has a first end that engages the body <NUM> and a second or terminal end that engages a ring <NUM> thereon. The ring <NUM> extends co-radially around the body <NUM> and engages all of the arms 432a, 432b, 432c, 432d so that the ring <NUM> and the arms 432a, 432b, 432c, 432d define a semi-spherical shape that encompasses part of the body <NUM> within the defined semi-sphere. When the tag <NUM> has been delivered from a first side <NUM> to a second side <NUM> of a wound <NUM>, the ring <NUM> contacts an outer tissue surface <NUM> of the first side <NUM> to provide a large and stable contact surface for the spring member <NUM> against the outer tissue surface <NUM>, as illustrated in <FIG>. The arms 432a, 432b, 432c, 432d can flex and bend to help the tag <NUM> apply tensile closing force between the two sides <NUM>, <NUM> of the wound <NUM> by applying an upward pulling force on the body <NUM> when they are in a compressed state upon initial delivery. For example, the arms 432a, 432b, 432c, 432d can be compressed toward the outer tissue surface <NUM> upon initial delivery as the tag <NUM> acts to close the wound <NUM>, as illustrated in <FIG>. The semi-spherical shape of the spring member <NUM> can thus be flattened and distorted toward the outer tissue surface <NUM> upon delivery such that a radius R1 of the semi-spherical shape is smaller than when the spring member <NUM> is in a resting or pre-deployed state. As the wound <NUM> closes, the arms 432a, 432b, 432c, 432d can revert to a less distorted semi-spherical orientation as less tensile closing force is needed to help the tag <NUM> draw the two sides <NUM>, <NUM> of the wound together, as illustrated in <FIG>, allowing the radius R1 of the semi-spherical shape to increase to a value more equivalent to the radius when the spring member <NUM> is in a resting state.

<FIG> illustrate another embodiment of a wound closure tag <NUM> similar to tags <NUM> and <NUM>. The wound closure tag <NUM> has an anchor <NUM>, a spring member <NUM>, and a body <NUM> extending therebetween. The spring member <NUM> is in the shape of a semi-circular plate that extends toward the anchor <NUM>. It has two plate arms or sides 532a, 532b that each engage the body <NUM> on one end and extend toward the anchor <NUM> on an opposite end. The arms 532a, 532b extend away from the body <NUM> to create the broad, semi-circular plate shape of the spring member <NUM>, forming a generally partial cylindrical shape with the body <NUM> extending from an inner surface within the semi-circular curve of the partial cylinder. Each of the arms 532a, 532b terminates in a cylindrical bar <NUM> that extends along the edge of each arm 532a, 532b positioned closer to the anchor <NUM>. The plate arms 532a, 532b extend away from the body <NUM> in a coplanar fashion to anchor <NUM>. However, various other alignments of the plate arms 532a, 532b are possible, such as arms 532a, 532b being perpendicular to anchor <NUM> and/or having the arms 532a, 532b aligned at various non-right angles to the anchor. When the tag <NUM> is delivered to a wound and extends from a first side to a second side of the wound, the cylindrical bars <NUM> contact an outer tissue surface of the first side of the wound to provide a stable contact surface between the spring member <NUM> and the tissue, similar to ring <NUM> of tag <NUM>. As the tag <NUM> applies tensile closing force to the wound, the arms 532a, 532b can flex and bend to help apply an increased force, similar to arms 432a, 432b, 432c, 432d. Because the spring member <NUM> has wide arms 532a, 532b, the force applied will be greater than a force applied by thinner arms, such as the arms on tag <NUM>. In other embodiments, the force applied by the spring member <NUM> can be adjusted by varying a thickness of the plate arms 532a, 532b and/or by varying manufacturing materials and thus varying mechanical properties of the spring member <NUM>, such as varying an elastic modulus of the spring member <NUM>, etc. In still other embodiments, a force of spring member <NUM> can be adjusted by varying a geometry of spring member <NUM>, such as by forming the spring member <NUM> into a semi-oval or a flexible flat plane, and thereby varying a depth and adjustable length of the body <NUM> and/or the spring member <NUM> between the cylinders <NUM> and the anchor <NUM>.

<FIG> illustrates another embodiment of a wound closure tag <NUM> similar to tags <NUM> and <NUM>. The wound closure tag <NUM> has an anchor <NUM>, a spring member <NUM>, and a body <NUM> extending therebetween. The spring member <NUM> is generally shaped like a heart or spade, forming a point <NUM> on an end opposite the anchor <NUM> and having two lobes 632a, 632b that each extend toward the anchor <NUM>. However, the spring member <NUM> can also be rounded on the end opposite the anchor <NUM>. Ends of the lobes 632a, 632b closest to the anchor <NUM> can rest against an outer tissue surface on a first side of a wound upon deployment, and the lobes 632a, 632b can each provide additional flex or tensile closing force to the anchor <NUM>.

Numerous other designs can be used for the spring members, as well. For example, <FIG> illustrate a variety of additional wound closure tags with a variety of different spring members. <FIG> illustrate each wound closure tag when viewed from the corresponding spring member toward the corresponding anchor, and <FIG> illustrate each wound closure tag when viewed from the side. For example, <FIG> illustrate a wound closure tag <NUM> with an anchor <NUM>, a body <NUM>, and a spring member <NUM> shaped like a coiled spring or spiral that is coiled around an end of the body <NUM> opposite the anchor <NUM> and bulges along a central portion. <FIG> illustrate a wound closure tag <NUM> with an anchor <NUM>, a body <NUM>, and a spring member <NUM> shaped like a coiled or spiraled cone with a point of the cone facing away from the anchor <NUM> and a wider base facing the anchor <NUM>. <FIG> illustrate a wound closure tag <NUM> with an anchor <NUM>, a body <NUM>, and a spring member <NUM> shaped like a wire frame of a cone with a spiraled point of the cone facing away from the anchor <NUM> and a wider base facing the anchor <NUM>. <FIG> illustrate a wound closure tag <NUM> with an anchor <NUM>, a body <NUM>, and a spring member <NUM> shaped like a cone with solid panels on the side and a point of the cone facing away from the anchor <NUM> with a wider base facing the anchor <NUM>. <FIG> illustrate a wound closure tag <NUM> with an anchor <NUM>, a body <NUM>, and a spring member <NUM> with arms similar to tag <NUM>, but that are angularly offset from the anchor <NUM>. <FIG> illustrate a wound closure tag <NUM> with an anchor <NUM>, a body <NUM>, and a spring member <NUM> that is a cylinder, made from various materials such as hydrogels, elastomers, thermoplastics, partially resorbable materials, foam, nitinol, various polymers, etc. The spring member <NUM> can also be expandable during use. <FIG> illustrate a wound closure tag <NUM> with an anchor <NUM>, a body <NUM>, and a spring member <NUM> that is an amorphous or expandable material, such as a biological tissue, a hydrogel, an alginate, etc. <FIG> illustrate a wound closure tag <NUM> with an anchor <NUM>, a body <NUM>, and a spring member <NUM> that comprises a plurality of disordered arms that project from an end of the body <NUM> opposite the anchor <NUM>, which results in a mop or feather duster appearance. <FIG> illustrate a wound closure tag <NUM> with an anchor <NUM>, a body <NUM>, and a spring member <NUM> in the shape of a cylinder arranged perpendicularly to the body <NUM>. The body <NUM> can slidably translate perpendicular to the centerline of the spring member <NUM>. The cylinder of spring member <NUM> can be collapsible and attached to the body <NUM> on an external or internal face of the spring member <NUM> away from the anchor <NUM>. All of these spring members can be collapsible during deployment, for example having expandable foam, frills, memory-retaining material such as nitinol kept in a compressed state of tension until deployment, etc., and they can be freeze-dried to allow deployment before they begin to expand, such as being a frozen hydrogel that begins to expand once in contact with heat and/or moisture.

The anchor can also be collapsible during deployment and expandable once delivered. For example, <FIG> illustrate a wound closure tag <NUM> with an anchor <NUM>, a body <NUM>, and a spring member <NUM> with arms similar to tag <NUM>. The anchor <NUM> has a freeze-dried hydrogel 792a attached thereto. During deployment as illustrated in <FIG>, the anchor <NUM> is in an unexpanded state because the hydrogel 792a does not have sufficient time to react to heat and/or moisture. However, after deployment, the anchor <NUM> expands as the hydrogel 792a interacts with heat and/or moisture in the body, as illustrated in <FIG>.

The various anchors on the wound closure tags discussed above are sized and shaped to be deployed through a delivery needle. The delivery needle passes through first and second sides of a wound and, while still puncturing both sides of the wound, passes an anchor of a wound closure tag therethrough to allow the anchor to move through the first and second sides and exit the tissue on the second side to secure itself thereto. The needle also assists in guiding the body of the wound closure tag during anchor placement so that the body can extend through the first and seconds sides of the wound between the anchor and a spring member of the wound closure tag positioned on the first side of the wound.

<FIG> illustrate an embodiment of a delivery needle <NUM> having a curved distal portion 800d, a channel <NUM> extending at least partially therealong, an ejection port <NUM> positioned at a distal end of the channel <NUM>, a sharp distal point <NUM>, and an open proximal end <NUM>. The channel <NUM> is sized to receive anchors of the various wound closure tags therein such that the anchors can slide along the channel <NUM> during delivery, and it has a slot <NUM> that forms an opening or passage from the channel <NUM> external to the needle <NUM> along which the bodies can slide during delivery. The ejection port <NUM> at the distal end of the channel <NUM> allows the anchors to be ejected from the delivery device. In some embodiments, the channel <NUM> can have an upward slope 802a at its distal end approaching the ejection port <NUM> to force the anchor to exit therefrom, as illustrated in <FIG> with a black bar showing a general path of a bottom of the channel <NUM> including the upward slope 802a. The distal point <NUM> can be formed from a variety of types of needle tips, such as a cutting and/or trocar tip needle having broad, solid penetrating sides. An exemplary loading process is illustrated using the wound closure tag <NUM> in <FIG>, with internal interactions illustrated by broken lines, however any wound closure tag can be used. The needle <NUM> can allow anchors to be loaded therein by passing the anchor <NUM> into the ejection port <NUM> and sliding the anchor <NUM> proximally along the channel <NUM> with the body <NUM> extending from the anchor <NUM> through the slot <NUM> and the spring member <NUM> coupled to the body <NUM> and positioned external to the needle <NUM>. The open proximal end <NUM> of the needle <NUM> can accept a flexible pushrod <NUM> therein so that, during delivery of the anchor to a wound site, the pushrod can push the anchor distally toward the distal tip <NUM> and the ejection port <NUM>. As the flexible pushrod <NUM> extends through the channel <NUM>, the needle <NUM> can force the anchor <NUM> out of the ejection port <NUM> as the anchor <NUM> slides along the slope 802a of the channel <NUM>.

The needle <NUM> can be made from a variety of materials, such as medical grade metal such as steel, various rigid plastics or polymers, etc., and a variety of pushrods can be used in the form of elongate shafts and made from various materials as well, such as inconel, spring steel, polymers, nitinol, polymer braided and woven steel composites, thermoplastics, elastomers, etc..

In use, once the anchor <NUM> has been loaded proximally into the needle <NUM>, the needle can be passed through tissue at a wound. As illustrated in <FIG>, a surgeon can grip a first side <NUM> of a wound <NUM> in tissue <NUM> of a patient using a variety of tools, such as forceps <NUM>. The distal point <NUM> of the needle <NUM> can then be passed through tissue on the first side <NUM> of the wound <NUM>. The needle <NUM> illustrated in <FIG> is placed on a handle <NUM>, however the needle <NUM> can be placed on or incorporated into a variety of devices, as discussed below. A second side <NUM> of the wound <NUM> can then be grasped, as illustrated in <FIG>, and the distal point <NUM> of the needle <NUM> can be passed therethrough, as illustrated in <FIG>. Thus, the needle <NUM> can extend across the wound <NUM> with a proximal side of the needle <NUM> in the first side <NUM> of the wound <NUM> and a distal side of the needle <NUM> in the second side <NUM> of the wound <NUM>. The distal point <NUM> can extend out of the second side <NUM>, and the channel <NUM> can thus form a passage or path through the wound <NUM>. Since the distal portion of the needle is curved, the path will be semi-circular.

The open proximal end <NUM> of the needle <NUM> can accept a flexible pushrod <NUM> therein, and the anchor <NUM> can be pushed distally toward the distal tip <NUM> and the ejection port <NUM> upon distal advancement of the pushrod <NUM>. The pushrod <NUM> can either be manually inserted and advanced by a surgeon or can be actuated through a variety of mechanisms discussed below. As the flexible pushrod <NUM> extends through the channel <NUM>, the needle <NUM> can force the anchor out the ejection port <NUM> as the anchor <NUM> slides along the slope 802a of the channel <NUM>, thus placing the anchor <NUM> on the second side <NUM> of the wound <NUM> with the body <NUM> extending through the two sides of the wound <NUM>. The spring member <NUM> will remain on the first side <NUM>, as illustrated in <FIG>. In various other embodiments, the needle can be passed through both sides of the wound simultaneously and/or forceps or other grasping instruments may not be needed depending on a comfort level of the surgeon and/or how severe or open a wound is.

Loading of one or more anchors into needles and mechanisms to actuate pushrods to pass the anchors therethrough can vary, as explained below. However, the basic process of passing a needle through each side of a wound and advancing a pushrod distally along a channel of the needle to deliver an anchor of a wound closure tag through the channel and across the wound will be used to provide delivery of the anchor and placement of the wound closure tag across the wound in the embodiments that follow.

While the needle <NUM> is loaded manually through the ejection port <NUM>, different loading mechanisms are possible. For example, <FIG> illustrate an embodiment of a delivery needle <NUM> that can be loaded from a proximal end to allow delivery of multiple anchors without having to interact with a distal end of the needle. Proximal loading can allow easier loading, including automatic loading discussed below, and can avoid hassle and accidental user needle sticks caused by loading through the ejection port. The needle <NUM> is a curved needle that is similar to needle <NUM>, with a channel <NUM> that has a slot <NUM> extending therealong, an ejection port <NUM> positioned at a distal end of the channel <NUM>, a sharp distal point <NUM>, and an open proximal end <NUM>. The channel <NUM> extends from the open proximal end <NUM> to the ejection port <NUM>. As such, the needle <NUM> can be loaded from the proximal open end <NUM>.

An exemplary loading process is illustrated using the wound closure tag <NUM> in <FIG>, however any wound closure tag can be used. As illustrated, the needle <NUM> can accept the anchor <NUM> through the proximal open end <NUM> and into the channel <NUM> while the body <NUM> extends through the channel <NUM> and will slide therealong with movement of the anchor <NUM>. The spring member <NUM> extends from the body <NUM> and will remain external to the needle. After the distal point <NUM> has been passed through two sides of a wound, the proximal open end <NUM> of the needle <NUM> can accept a flexible pushrod <NUM> that extends distally along the channel <NUM> to force the anchor <NUM> distally through the channel <NUM>, as illustrated in <FIG> with broken lines representing internal engagements. The needle <NUM> can force the anchor <NUM> out the ejection port <NUM>. As with channel <NUM> of needle <NUM>, the channel <NUM> provides a path along which the anchor <NUM> can travel to move the anchor from a first side of a wound to a second side with the body <NUM> extending through the slot <NUM> and trailing behind the anchor <NUM> and the spring member <NUM> remaining on the first side. The anchor <NUM> is described as being loaded into the proximal open end <NUM> of the needle <NUM>. However, the anchor <NUM> can be loaded through the ejection port <NUM> if desired, similar to needle <NUM>.

As indicated above, the needle <NUM> can either be manually loaded by a surgeon inserting the anchor into the needle <NUM> or can be loaded automatically through use of a variety of delivery devices, as discussed below. <FIG> illustrate one embodiment of a delivery device <NUM> for delivering wound closure tags. The delivery device <NUM> can allow rapid automatic loading of one or more wound closure tags during use, allowing a surgeon to quickly deliver wound closure tags to close a wound. It can also have a removable and replaceable wound closure tag cartridge that can allow a surgeon to deliver multiple wound closure tags during one operation and/or allow a surgeon to easily use different types of wound closure tags during a single operation by simply changing out the cartridge. In general, the device <NUM> has a housing <NUM>, a curved needle <NUM>, an actuation mechanism with a trigger <NUM>, and a cartridge <NUM>.

The housing <NUM> is an approximately rectangular body that slopes or curves downward from a proximal end 1002p to a distal end 1002d to provide increased visibility when operating the device <NUM>. The housing <NUM> has a cartridge opening <NUM> in the form of a cavity configured to removably receive the cartridge <NUM> therein and hold the cartridge <NUM> in rotatable engagement through a variety of mechanisms, such as clips, protrusion and detent combinations, etc. The housing <NUM> also has a body slot <NUM> extending between the cartridge <NUM> and a channel <NUM> of the needle <NUM>, discussed below, to allow a body and a spring member of a wound closure tag to exit the cartridge <NUM> and advance along the needle <NUM> during delivery of an anchor, as discussed below. <FIG> show the device <NUM> used with wound closure tag <NUM>, however any wound closure tag can be used. The housing <NUM> can be designed and shaped to be held similar to a needle driver to help surgeons quickly understand how to use the device, for example by being held in a supination orientation illustrated in <FIG>, a neutral orientation as shown in <FIG>, or a pronation orientation as shown in <FIG>.

The needle <NUM> is similar to needle <NUM> discussed above and extends distally from the distal end 1002d of the housing <NUM>. It has a sharp distal point <NUM>, an ejection port <NUM>, an open proximal end <NUM>, and a channel <NUM> extending between the two. The needle <NUM> can be advanced through first and second sides of a wound and can deliver the anchor <NUM> of the wound closure tag <NUM> across the wound. The anchor <NUM> can be loaded from the open proximal end <NUM> of the needle <NUM>, which is aligned with the cartridge <NUM>.

The cartridge <NUM> contains a plurality of wound closure tags <NUM> therein. The cartridge <NUM> can automatically load a wound closure tag <NUM> into the needle <NUM> upon actuation of the device <NUM> during use and can be rotated to align another wound closure tag <NUM> after delivery of the first. The illustrated cartridge <NUM> is a circular-shaped body that can be received in and can rotate relative to the cartridge opening <NUM>, similar to the rotatable bullet cylinder in a revolver firearm, however other configurations are possible as discussed below, such as top-loading or side-loading cartridges. The cartridge <NUM> has a distal side 1040d, a proximal side 1040p, and a plurality of tag openings <NUM> in the form of cavities extending from the distal side 1040d to the proximal side 1040p. The tag openings <NUM> are each sized and shaped to removably receive a select wound closure tag, such as the illustrated tag <NUM>. Each tag opening <NUM> receives the anchor <NUM> in an anchor cavity 1042a that is offset from and adjacent to a central longitudinal axis A1 of the cartridge <NUM>. Each anchor cavity 1042a is positioned to align with the open proximal end <NUM> of the needle <NUM> upon rotation of the cartridge <NUM>. Each opening <NUM> also has a body cavity 1042b that extends radially out from the anchor cavity 1042a away from the central longitudinal axis A1 of the cartridge <NUM> for receiving the body <NUM> of the tag <NUM>. The body cavity 1042b terminates in a spring member cavity 1042c placed radially farthest away from the central longitudinal axis A1 of the cartridge <NUM> that receives the spring member <NUM> therein, resulting in the cartridge <NUM> being configured to receive a plurality of tags <NUM> that fan out from the central longitudinal axis A1. The cartridge <NUM> can align one of the anchor cavities 1042a with the open proximal end <NUM> of the needle <NUM> and can receive a pushrod <NUM> through the anchor cavity 1042a from the proximal side 1040p so that any anchor <NUM> contained therein is forced distally into the open proximal end <NUM> of the needle <NUM>, thus loading the anchor <NUM> into the needle <NUM> and causing the associated wound closure tag <NUM> to move distally out of the cartridge <NUM> perpendicular to the central longitudinal axis A1. The anchor cavity 1042a can receive the pushrod <NUM> therethrough as the tag <NUM> is delivered to a wound, discussed below. Once delivery is successful, the pushrod <NUM> is retracted proximally out of the anchor cavity 1042a, and the cartridge <NUM> can be rotated about its central longitudinal axis A1 to align the next anchor cavity 1042a with the open proximal end <NUM> of the needle <NUM> for optional delivery of another tag <NUM>. In some embodiments, the cartridge <NUM> can be disposable after use.

The pushrod <NUM> can be part of the actuation mechanism that is used to deliver one or more wound closure tags <NUM> from the cartridge <NUM> along the needle <NUM> and across a wound. The illustrated actuation mechanism includes a trigger <NUM>, a lever <NUM>, first and second gears <NUM>, <NUM>, the pushrod <NUM>, a rack <NUM>, and an alignment member <NUM>. The trigger <NUM> is biased to extend away from the housing <NUM> and is pivotably coupled thereto at a pivot point 1020p. The trigger <NUM> is coupled to the lever <NUM> by a slot 1020a formed in the trigger that allows the lever <NUM> to slide therealong upon actuation of the trigger <NUM> by pivoting the trigger <NUM> toward the housing <NUM>. The trigger <NUM> has a stop member 1020b that contacts the housing <NUM> and stops movement of the trigger <NUM> upon full actuation. The lever <NUM> is pivotably coupled to the first and second gears <NUM>, <NUM> on a side opposite to the trigger <NUM> at pivot point 1022p. The first and second gears <NUM>, <NUM> are coupled to the housing <NUM> at pivot points 1024p, 1026p. Actuation of the trigger <NUM> causes the lever <NUM> to move toward the housing <NUM> and slightly proximally, causing the lever <NUM> to rotate the gears <NUM>, <NUM> about the pivot points 1024p, 1026p, thereby causing the gears <NUM>, <NUM> to rotate toward the distal end 1002d of the housing <NUM>. The gears <NUM>, <NUM> have teeth extending therefrom that engage corresponding openings in the rack <NUM>, which is an elongate member that extends in a slot from the proximal end 1002p of the housing <NUM> toward the distal end 1002d and is distally slidable therein. The rack <NUM> has the pushrod <NUM> fixed to and extending from a distal end thereof, and it has an alignment member <NUM> at the distal end. As the gears <NUM>, <NUM> rotate toward the distal end 1002d of the housing <NUM>, the teeth thereon force the rack <NUM> distally, which in turn forces the pushrod <NUM> distally. If the cartridge <NUM> is aligned with the pushrod <NUM> and the needle <NUM>, the pushrod <NUM> passes through the aligned anchor cavity 1042a of the cartridge <NUM>, through the open proximal end <NUM> of the needle <NUM>, and into the channel <NUM>. Upon release of the trigger <NUM>, the process is reversed, moving the lever <NUM> away from the housing <NUM> and causing proximal rotation of the gears <NUM>, <NUM>. Upon proximal rotation, the teeth of the gears <NUM>, <NUM> push the rack <NUM> proximally in the housing <NUM>, which causes the pushrod <NUM> to move proximally and retract proximally out of the needle <NUM> and the cartridge <NUM>. The alignment member <NUM> is configured to slide distally and proximally in the housing <NUM> with distal and proximal movement of the rack <NUM>, and it sits in an alignment slot <NUM> inside the housing <NUM> that terminates at a distal point of full actuation to keep the rack <NUM> and the pushrod <NUM> aligned during movement and to prevent over-actuation. The pushrod <NUM> can also be of a singular flexible construction or can have a flexible portion 1030a that moves slidably through a friction reducing guide 1030b, as illustrated in <FIG>. Furthermore, one or more springs can be provided in the housing to provide tactile feedback upon actuation and/or to slow movements of mechanisms therein. For example, a spring can be provided on the lever <NUM> to provide tactile feedback and bias the device <NUM> to a non-actuation state. A spring can also be provided around the alignment member <NUM> to slow return of the rack <NUM> after actuation.

Thus, in use, a surgeon can load the cartridge <NUM> into the housing <NUM> and align the cartridge <NUM> with the needle <NUM>. The needle <NUM> can be passed through two sides of a wound such that the needle <NUM> extends thereacross and the distal point <NUM> protrudes from the second side. The trigger <NUM> can be actuated, causing rotation of the gears <NUM>, <NUM> and subsequent distal motion of the rack <NUM> and the pushrod <NUM>. The pushrod <NUM> can extend distally through the cartridge <NUM> to move an anchor <NUM> of a tag <NUM> through the open proximal end <NUM> of the needle <NUM> and into the channel <NUM>. The pushrod <NUM> can continue to advance distally through the channel <NUM> until the anchor <NUM> of the tag <NUM> is moved out of the ejection port <NUM> and delivered to the second side of the wound, thus causing delivery of the tag <NUM> similar to the process discussed above. During movement of the anchor <NUM>, the body <NUM> and the spring member <NUM> are distally advanced out of the cartridge <NUM>. The body <NUM> trails the anchor <NUM> along the channel <NUM> of the needle <NUM> and through the body slot <NUM> of the housing <NUM>. As the anchor <NUM> is passed through the channel <NUM> and out of the ejection port <NUM> to be placed on the second side of the wound, the body <NUM> trails the anchor <NUM> through the wound to extend from the second side to the first side, and the spring member <NUM> will rest against the first side of the wound after being pulled free from the cartridge <NUM>.

The cartridge <NUM> is configured to be rotated automatically and is automatically aligned with the needle <NUM>. However, in various other embodiments, the cartridge can be manually rotated and/or aligned, and a variety of mechanisms can be incorporated into the cartridge, the housing <NUM>, or some combination of the two to assist 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. can all be used. For example, <FIG> illustrates a cartridge <NUM> similar to cartridge <NUM>, however it has a plurality of angled notches <NUM> along a proximal side 2040p thereof. The angled notches <NUM> receive a pin <NUM> disposed in a housing (not shown) similar to housing <NUM>, and the pin <NUM> is biased into engagement with the cartridge <NUM> by a spring <NUM>. The angled notches <NUM> are angled such that counterclockwise rotation of the cartridge <NUM> (as viewed when facing the proximal side 2040p) causes the pin <NUM> to pop out of engagement with a first notch <NUM> and run along the proximal side 2040p until a second notch <NUM> is reached, at which point the pin <NUM> pops into engagement with the second notch <NUM>. This action can ensure alignment of the cartridge <NUM> while also providing an audible click or pop upon alignment. The pin <NUM> can also resist clockwise rotation to ensure the surgeon continues to rotate to alignment positions that have wound closure tags loaded therein until every wound closure tag has been delivered. However, other engagements are possible, and mechanisms can be incorporated into the device <NUM> to automatically advance the cartridge <NUM>. For example, one or more pawls can be attached to the trigger <NUM>, the lever <NUM>, the gears <NUM>, <NUM>, etc. to engage a ratchet to rotate the cartridge to the next, not-yet-delivered tag <NUM>, and another pawl can lodge in a small depression on the cartridge <NUM> to stop the cartridge <NUM> in a particular position so it is lined up with the needle <NUM> and the pushrod <NUM>, similar to the rotatable bullet cylinder in a revolver firearm.

While the delivery device <NUM> was described above with a rotating cartridge <NUM>, a variety of different delivery devices and loading mechanisms are possible, such as side or top loading and loading parallel to the pushrod. <FIG> illustrate another embodiment of a delivery device <NUM> that is similar to delivery device <NUM>, but that has top-loaded wound closure tags. The device <NUM> has a housing <NUM>, a curved needle <NUM>, an actuation mechanism with a trigger <NUM>, and a receiving port <NUM> for seating a plurality of wound closure tags. The housing <NUM> is in the shape of a handgun with a pistol grip 3002a, and the needle <NUM> protrudes distally therefrom. The housing <NUM> has a body slot <NUM> (similar to body slot <NUM>) through a side surface thereof and along which bodies of wound closure tags pass while the corresponding anchor is being delivered through the needle <NUM>. <FIG> illustrate a plurality of wound closure tags <NUM>, however any wound closure tag can be used. The needle <NUM> is structured similarly to needle <NUM> and is loaded through a proximal open end (not shown) in the housing <NUM>, and it has a channel aligned with the receiving port <NUM>. The trigger <NUM> of the actuation mechanism is similar to trigger <NUM> and is engaged with the pistol grip 3002a of the housing <NUM> so that actuation of the trigger <NUM> by pivoting the trigger <NUM> toward the pistol grip 3002a can be achieved while holding the device <NUM> by the pistol grip 3002a. Similar to the actuation mechanism of the device <NUM>, actuation of the trigger <NUM> causes rotation of one or more gears (not shown) in the housing <NUM> to drive a rack (not shown) distally to advance a pushrod (not shown) distally along a slot aligned with a bottom of the receiving port <NUM> and the proximal open end of the needle <NUM>.

The receiving port <NUM> is shaped to receive a plurality of wound closure tags <NUM> that are all arranged in series along a tag spine <NUM> such that each anchor <NUM> of each tag <NUM> is frangibly connected to the tag spine <NUM>. A bottom of the receiving port in the housing <NUM> is aligned at its distal end with the proximal open end of the needle <NUM>, and at its proximal end with the pushrod. It thus acts as an alignment surface that receives a next anchor <NUM> to be delivered. The receiving port <NUM> has an anchor receiving channel 3040a that receives the plurality of anchors <NUM> connected to the spine <NUM> vertically through the top of the housing <NUM> so that the anchors <NUM> are all aligned to be loaded distally into the proximal open end of the needle <NUM> when each anchor <NUM> reaches the bottom of the receiving port <NUM>. The receiving port <NUM> also has a body channel 3040b that extends between the anchor receiving channel 3040a and the body slot <NUM> on the housing <NUM> such that the plurality of bodies <NUM> connected to the corresponding plurality of anchors <NUM> loaded into the device <NUM> can move vertically downward along the body channel 3040b with downward movement of the anchors <NUM> and spine <NUM>, and then each body <NUM> can move distally along the body slot <NUM> with its corresponding anchor <NUM> upon delivery through the needle <NUM>. The corresponding plurality of spring members <NUM> extend along a side of the housing <NUM> and are not received therein. A spinal channel 3040c is formed vertically adjacent to the anchor receiving channel 3040a in the housing and can optionally extend entirely therethrough. The spinal channel 3040c receives the spine <NUM> therealong and extends below the bottom of the anchor receiving channel 3040a. As such, a bottom portion of the spine <NUM> that contained anchors <NUM> that have already been delivered has room to continue to move downward so that the next anchor <NUM> to be delivered can be kept correctly aligned with the pushrod and the needle <NUM> on the bottom of the receiving port <NUM> without interference from the spine <NUM>.

In use, the spine <NUM> with the plurality of wound closure tags <NUM> frangibly attached thereto can be loaded into the receiving port <NUM> with the anchors <NUM> vertically aligned in the anchor channel 3040a and the bodies <NUM> vertically aligned in the body channel 3040b. A wound closure tag <NUM> that is first in line along the spine <NUM> can come to rest at the bottom of the receiving port <NUM>. The tag <NUM> can be seated in alignment with the pushrod aligned proximally behind the anchor <NUM> and the open end of the needle <NUM> aligned distally in front of the anchor <NUM>. After passing the needle <NUM> through both sides of a wound, as discussed above, the trigger <NUM> can be actuated to cause delivery of the tag <NUM>. Upon actuation of the trigger <NUM>, gears and a rack inside the housing drive the pushrod distally, similar to device <NUM>, to pass the pushrod through the bottom of the receiving port <NUM>. As the pushrod passes through the receiving port, the pushrod contacts a proximal end of the first anchor <NUM> along the spine <NUM> and forces it distally into the proximal open end of the needle <NUM>. The distal force of the pushrod snaps, cuts, or breaks the first anchor <NUM> free of the spine <NUM>, and the first anchor <NUM> is pushed distally through the needle <NUM> and delivered to the second side of the wound, similar to device <NUM>. As the first anchor <NUM> is pushed distally, the first body <NUM> trails the anchor <NUM> along the body slot <NUM> in the housing <NUM>, and the first spring member <NUM> is pulled distally with the body <NUM> but remains on the first side of the wound. Upon release of the trigger <NUM>, the actuation process is reversed to cause the pushrod to retract proximally out of the needle <NUM> and the receiving port <NUM>. Once the pushrod is retracted proximally out of the receiving port <NUM>, a second anchor <NUM> of a second tag <NUM> in line along the spine <NUM> can fall into place at the bottom of the receiving port <NUM> in preparation for the actuation process to be repeated and the pushrod to break or snap off the second anchor <NUM> from the spine <NUM> during delivery. However, in other embodiments, a variety of other tag advancement mechanisms are possible to move the next tag <NUM> into alignment for delivery, for example a spring member in the housing can apply downward pressure on the spine or can be engaged from underneath the spine to pull the spine down, a ratchet and/or gear mechanism can be located in the housing that is actuated upon each pull of the trigger to move the spine down a corresponding distance to align the next anchor, the plurality of tags <NUM> and the spine <NUM> could be loaded into a top-loading vertical cartridge that contains a spring member in an upper portion thereof and provides downward force on the spine <NUM>, the spine <NUM> can be manually moved, etc..

A plurality of wound closure tags can also be loaded from a side of the device in various embodiments. For example, <FIG> illustrates another embodiment of a delivery device <NUM> for wound closure tags similar to delivery device <NUM>. The device <NUM> has a housing <NUM>, a curved needle <NUM>, an actuation mechanism with a trigger <NUM>, and a receiving port <NUM> for receiving a plurality of wound closure tags. The housing <NUM> is in the shape of a handgun with a proximally-angled pistol grip 4002a, and the needle <NUM> protrudes distally therefrom. The housing <NUM> has a body slot <NUM> similar to body slot <NUM> and along which bodies of wound closure tags pass while the corresponding anchor is being delivered through the needle <NUM>. However, the body slot <NUM> is in a top surface of the housing <NUM> rather than a side surface. <FIG> illustrate a plurality of wound closure tags <NUM>, however any wound closure tag can be used. The needle <NUM> is structured similarly to needle <NUM> and is loaded through a proximal open end (not shown) in the housing <NUM>, and it has a channel aligned with the receiving port <NUM>. The trigger <NUM> of the actuation mechanism is similar to trigger <NUM> and is engaged with the pistol grip 4002a of the housing <NUM> so that actuation of the trigger <NUM> by pivoting the trigger <NUM> toward the pistol grip 4002a can be achieved while holding the device <NUM> by the pistol grip 4002a. Similar to the actuation mechanism of the device <NUM>, actuation of the trigger <NUM> causes rotation of one or more gears (not shown) in the housing <NUM> to drive a rack (not shown) distally to advance a pushrod (not shown) distally along a slot aligned with a bottom of the receiving port <NUM> and the proximal open end of the needle <NUM>.

The receiving port <NUM> is shaped to receive a plurality of wound closure tags <NUM> that are all arranged in series along a tag spine <NUM> such that each anchor <NUM> of each tag <NUM> is frangibly connected to the tag spine <NUM>, as illustrated in <FIG>. A terminal end of the receiving port <NUM> along a central axis of the housing <NUM> acts similarly to the bottom of the receiving port <NUM> in the housing <NUM> as an alignment and stopping surface for a next anchor <NUM> to be delivered, and it is aligned on its distal end with the proximal open end of the needle <NUM> and on its proximal end with the pushrod. The receiving port <NUM> also has an anchor receiving channel (not shown) that receives the plurality of anchors <NUM> connected to the spine <NUM> horizontally through the side of the housing <NUM> so that the anchors <NUM> are all each aligned to be loaded distally into the proximal open end of the needle <NUM> when each anchor <NUM> reaches the terminal end of the receiving port <NUM>. The receiving port <NUM> also has a body channel (not shown) that extends between the anchor receiving channel and the body slot <NUM> on the housing <NUM> such that the plurality of bodies <NUM> connected to the corresponding plurality of anchors <NUM> loaded into the device <NUM> can move horizontally along the body channel and then distally along the body slot <NUM> with its corresponding anchor <NUM> upon delivery through the needle <NUM>. The corresponding plurality of spring members <NUM> extend vertically above the housing <NUM> and are not received therein. A spinal channel (not shown) is formed horizontally below the anchor receiving channel in the housing and can optionally extend entirely therethrough. The spinal channel receives the spine <NUM> therealong and extends horizontally beyond the terminal end of the receiving port <NUM>. As such, a first portion of the spine <NUM> that contained anchors <NUM> that have already been delivered has room to continue to move horizontally so that the next anchor <NUM> to be delivered can be kept correctly aligned with the pushrod and the needle <NUM> at the terminal end of the receiving port <NUM> without interference from the spine <NUM>.

The receiving port <NUM> aligns with a tab housing <NUM> with a holding portion 4042a and a coupling member 4042b. The coupling member 4042b extends around the housing <NUM> to couple the holding portion 4042a to a side of the housing aligned with the receiving port <NUM>. The holding portion 4042a is a generally rectangular body that receives the plurality of tags <NUM> and the spine <NUM> therein to provide protection to the plurality of anchors <NUM> and the spine <NUM> during use. The holding portion 4042a can also have one or more anchor advancement mechanisms therein, such as a spring or rotatable knob at an end opposite the receiving port <NUM> that can apply horizontal force onto the spine <NUM> to keep a next tag <NUM> to be delivered in alignment with the needle <NUM> and the pushrod.

In use, the device <NUM> works similarly to device <NUM>. The spine <NUM> with the plurality of wound closure tags <NUM> frangibly attached thereto can be loaded into the receiving port <NUM>, and the tab housing <NUM> can be affixed to the device housing <NUM>. A first wound closure tag <NUM> that is first in line along the spine <NUM> can come to rest at the terminal end of the receiving port <NUM> in alignment with the pushrod proximally behind a first anchor <NUM> in line and in alignment with the proximal open end of the needle <NUM> distally in front of the first anchor <NUM>. After passing the needle <NUM> through both sides of a wound, the trigger <NUM> can be actuated to cause delivery of the tag <NUM>. Upon actuation of the trigger <NUM>, gears and a rack inside the housing drive the pushrod distally to pass the pushrod through the terminal end of the receiving port <NUM>. The pushrod thus breaks off the first anchor <NUM> from the spine <NUM> and forces it distally into the proximal open end of the needle <NUM>. The anchor <NUM> is forced distally through the channel of the needle <NUM> and delivered to the second side of the wound with the body <NUM> extending across the wound and the spring member <NUM> remaining on the first side. Upon release of the trigger <NUM>, the actuation process is reversed to cause the pushrod to retract proximally out of the needle <NUM> and the receiving port <NUM>. Once the pushrod is retracted proximally out of the receiving port <NUM>, a second anchor <NUM> of a second tag <NUM> in line along the spine <NUM> can move horizontally into place. As referenced above, such movement can be caused by a spring or rotatable knob in the holding portion 4042a that applies horizontal force to the spine <NUM>. However, other mechanisms are possible in other embodiments, such as a spring member in the housing, a ratchet and/or gear mechanism can be located in the housing that is actuated upon each pull of the trigger, the spine <NUM> can be manually moved, etc..

<FIG> illustrates another embodiment of a delivery device <NUM> similar to device <NUM> with a side loading mechanism. The device <NUM> has a housing <NUM>, a curved needle <NUM>, an actuation mechanism with a trigger (not illustrated), a receiving port <NUM> for a plurality of wound closure tags, and a body slot <NUM>. However, the device <NUM> does not have a tab housing <NUM> thereon. A spinal channel 5040c similar to spinal channel of the device <NUM> extends entirely horizontally through the device <NUM> such that it is open on a side opposite to the receiving port <NUM>. The spinal channel 5040c receives the spine <NUM> coupled to the plurality of tags <NUM> therethrough so that a first portion of the spine <NUM> that has already had its anchors <NUM> removed therefrom can extend horizontally away from the device <NUM> during use.

The devices <NUM>, <NUM>, <NUM> have wound closure tags loaded in a perpendicular direction to movement of the corresponding pushrod. However, a plurality of wound closure tags can be loaded in a direction parallel with a pushrod of a device. <FIG> illustrate a loading and delivery portion of another embodiment of a delivery device for wound closure tags similar to devices <NUM>, <NUM>, and <NUM> discussed above. However, instead of having a side or top loading mechanism, the loading and delivery portion illustrated in <FIG> has two channels extending parallel to each other, namely a pushrod channel <NUM> and a wound closure tag channel <NUM>. The pushrod channel <NUM> receives a pushrod <NUM> therethrough upon actuation of the device, and the wound closure tag channel <NUM> receives a plurality of wound closure tags <NUM> therethrough frangibly connected linearly onto a geared spine <NUM>. While tags <NUM> are illustrated in <FIG>, any wound closure tag can be used, such as the wound closure tag <NUM> on a spine <NUM> in <FIG>. The wound closure tag channel <NUM> has a spine channel portion 6002a, an anchor channel portion 6002b, a body channel portion 6002c, and a spring member channel portion 6002d that each receive the corresponding spine <NUM>, anchors <NUM>, bodies <NUM>, and spring members <NUM> therein, respectively, when the spine <NUM> and the plurality of tags <NUM> are loaded into the device. The spine <NUM> and the plurality of tags <NUM> can be inserted into the wound closure tag channel <NUM> from a proximal end of the device by sliding them in a distal direction. The pushrod channel <NUM> and the wound closure tag channel <NUM> initially extend in a direction parallel with each other and side-by-side in the housing of the device from a proximal portion of the device toward a distal end, as illustrated in <FIG> and <FIG>. However, as highlighted by black bars in <FIG>, the wound closure tag channel <NUM> shifts into alignment with and merges into the pushrod channel <NUM> at a point that is proximal to a needle of the device but distal to the pushrod <NUM> itself. As such, the wound closure tag channel <NUM> effectively terminates into the pushrod channel <NUM>. At the point where the wound closure tag channel <NUM> merges into the pushrod channel <NUM>, the spine <NUM> is advanced distally so that the anchor <NUM> of the next tag <NUM> to be delivered in series is advanced into the merged portion of the pushrod channel <NUM> proximal to the needle and distal to the pushrod <NUM> while any subsequent tags <NUM> remain slightly proximal to the point of merger in the wound closure tag channel <NUM>. As such, the anchor <NUM> of the next tag <NUM> to be delivered rests alone in the merged portion of the pushrod channel <NUM> with the body <NUM> and the spring member <NUM> extending vertically above the merged portion of the pushrod channel <NUM>. Upon actuation of the device using any of the mechanisms discussed above, such as by distal advancement of a rack <NUM> coupled to the pushrod <NUM>, the pushrod <NUM> advances distally through the pushrod channel <NUM>, including the merged portion of the channel in which the next tag <NUM> is positioned. The anchor <NUM> of the to-be-delivered tag <NUM> is snapped, cut, or broken from the spine <NUM>, and the pushrod <NUM> forces the anchor <NUM> distally into a channel of the needle and out a distal side for delivery to a second side of a wound. The pushrod <NUM> is then retracted proximally out of the merged portion of the pushrod channel <NUM>, and the spine <NUM> is advanced again to load the next tag <NUM> into the merged portion of the pushrod channel <NUM>. While a merged portion of the pushrod channel <NUM> has been discussed herein, the merged portion can also be the proximal open end of the needle such that the needle couples directly to the pushrod channel <NUM> and the wound closure tag channel <NUM> at the point of merger. The spine <NUM> is advanced distally in a controlled manner through engagement of gear(s) with teeth arranged along a bottom surface of the spine <NUM>. The gear(s) can be rotated automatically upon actuation of the device. However, a variety of other advancement mechanisms can be used, such as manual advancement, spring mechanisms, rotation and/or actuation of various levers, knobs, buttons, release switches, etc..

In other embodiments, a spine can be excluded and the anchors of the plurality of wound closure tags can be frangibly coupled or individually arranged directly thereto. For example, <FIG> illustrates a delivery device <NUM> similar to the devices discussed above. The device <NUM> has a housing <NUM>, a curved needle <NUM>, a receiving port <NUM> that extends from a proximal end to a distal end of the housing <NUM>, and an actuation mechanism having a pushrod <NUM>. A plurality of wound closure tags <NUM> are provided that are frangibly coupled to each other through their anchors <NUM> being engaged end-to-end in a linear series. While tags <NUM> are illustrated herein, any wound closure tags could be used. The plurality of wound closure tags <NUM> are loaded into the receiving port <NUM> on a proximal end thereof, and they are arranged distally in series through the housing <NUM> while waiting to be deployed. The anchors <NUM> are held in the housing <NUM> with the bodies <NUM> extending through the housing <NUM> along the receiving port <NUM> and the spring members <NUM> extend vertically above the housing <NUM>. An initial tag <NUM> to be delivered is forced horizontally out of the receiving port <NUM>, breaking or separating the corresponding anchor <NUM> from the remaining anchors <NUM>, and into a delivery channel <NUM>. As such, the anchor <NUM> of the corresponding tag <NUM> is aligned in the delivery channel <NUM> distally to the pushrod <NUM> and proximally to a proximal open end of the needle <NUM>. Upon actuation of the device <NUM>, similar to the actuation mechanisms discussed above, the pushrod <NUM> is driven distally forward through the delivery channel <NUM>, through the proximal open end, and along a channel of the needle <NUM>. The pushrod <NUM> encounters and forces the anchor <NUM> of the tag <NUM> distally for delivery, and the anchor <NUM> of the tag is subsequently delivered across a wound to a second side. The body <NUM> of the delivered tag <NUM> passes through the delivery channel <NUM> and trails the anchor <NUM> across the wound, and the spring member <NUM> of the delivered tag <NUM> moves distally with movement of the anchor <NUM> but remains on a first side of the wound. A variety of different mechanisms can be used to break and move the to-be-delivered tag <NUM> horizontally into the delivery channel <NUM>, such as gear and push member interactions triggered by actuation of the device, spring mechanisms, manual force, etc..

Some delivery devices can also use a mechanical actuation mechanism similar to the devices discussed above while using manual loading. For example, <FIG> illustrate a delivery device <NUM> similar to device <NUM> for delivering wound closure tags. The device <NUM> has a housing <NUM>, a curved needle <NUM>, an actuation mechanism with a trigger <NUM>, a tag loading port <NUM>, and a body slot <NUM> in the housing <NUM>. An anchor of a wound closure tag, such as one of the wound closure tags discussed above, is inserted into the tag loading port <NUM>. Inside the tag loading port <NUM>, the anchor is aligned in a position proximal to the open end of the needle <NUM> and in a position distal to a pushrod. After the needle <NUM> has been passed through two sides of a wound, the trigger <NUM> can be actuated to cause distal advancement of the pushrod through similar mechanisms to those discussed above. The pushrod can force the anchor distally into and through the needle <NUM>, resulting in delivery of the anchor on a second side of the wound. A corresponding body of the tag slides along the body slot <NUM> as it trails the anchor being delivered, and a corresponding spring member is moved distally with delivery of the anchor but remains on the first side of the wound. A second tag can be loaded into the device <NUM>. Tags can also optionally be loaded through an ejection port on the needle <NUM>, as discussed above in detail.

While triggers have been illustrated for actuation and various manual, gravity-fed, or spring or rotational mechanisms have been discussed for wound closure tag advancement, a variety of different actuation and advancement mechanisms can be used in other embodiments, such as slider releases and/or push button(s) on the housing. Removable cartridges containing a plurality of wound closure tags connected, stacked, and/or arranged in series can also be used that can clip into and be subsequently released from the device using various clips, slider releases, push buttons, etc. Furthermore, while various spines are shown, other mechanisms to index and deploy wound closure tags can be used, such as frangibly connecting anchors directly together, frangibly connecting spring members directly together, or some combination of the two, etc. Various device embodiments discussed herein can also generally mimic needle drivers in ergonomic shape, manner of use, and overall design to allow surgeons to feel comfortable when first using the various delivery devices.

In practice, the wound closure tags discussed herein have been shown to provide faster and more effective healing and better stress displacement than sutures or staples. For example, <FIG> illustrate a wound <NUM> closed using the wound closure tag <NUM> discussed above at Day <NUM>, at Day <NUM>, and at Day <NUM>, respectively. The wound <NUM> shows significant healing to the point of the line of incision being almost entirely gone by Day <NUM>. A similar wound <NUM> was closed using sutures, and <FIG> illustrate healing at Day <NUM>, at Day <NUM>, and at Day <NUM>, respectively. The wound <NUM> has closed by Day <NUM>, but the incision line is still visible. Finally, another similar wound <NUM> was closed using staples, and <FIG> illustrate healing at Day <NUM>, at Day <NUM>, and at Day <NUM>, respectively. The wound <NUM> still shows indications that the incision is in the process of fully closing at Day <NUM>. Accordingly, the wound closure tag provides improved healing as compared to sutures and staples.

Furthermore, <FIG> illustrate a tensile stress or pull test applied to a suture <NUM> used to close a wound in tissue. The suture <NUM> caused tearing and splitting of the skin caused by uneven distribution of force through and across the wound, as can be seen in <FIG>. A second tensile stress or pull test was conducted on a wound closure tag <NUM>, similar to tag <NUM> discussed herein, as illustrated in <FIG>. The tag <NUM> caused significantly less tearing and splitting of the skin caused by the greater distribution of force through the wound, as can be seen in <FIG>.

All of the devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the devices can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the devices, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the devices can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the devices can be reassembled for subsequent use either 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 can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly.

It is preferred that devices disclosed herein be sterilized before use. This can be done by any number of ways known to those skilled in the art including beta or gamma radiation, ethylene oxide, steam, and a liquid bath (e.g., cold soak). It is preferred that device, if implanted, is hermetically sealed. This can be done by any number of ways known to those skilled in the art.

Claim 1:
A system for closing a wound, comprising:
at least one wound closure member (<NUM>) having a first anchor (<NUM>), a spring member (<NUM>), and a body (<NUM>) extending between and coupling the first anchor (<NUM>) and the spring member (<NUM>);
a curved delivery needle (<NUM>) having a proximal open end (<NUM>), a distal end having an ejection port (<NUM>) thereon and terminating in a distal point (<NUM>), and a channel (<NUM>) extending between the proximal open end (<NUM>) and the ejection port (<NUM>), the channel (<NUM>) being configured to slidably receive the anchor (<NUM>); and
a pushrod (<NUM>) slidably coupled to the curved delivery needle (<NUM>) and configured to translate the first anchor (<NUM>) of the wound closure member (<NUM>) along the channel (<NUM>) from the proximal open end (<NUM>) to the ejection port (<NUM>) of the delivery needle (<NUM>);
characterised in that the spring member (<NUM>) is a flexible elastic body co-operable with the first anchor (<NUM>) and the body (<NUM>) to apply an effective tensile closing force between a first and second side (<NUM>,<NUM>) of the wound (<NUM>) and is configured to apply an adjustable eversion closure force to the wound (<NUM>) based on movement of the wound (<NUM>) and a shape of the spring member (<NUM>) when the spring member (<NUM>) is positioned on the second side (<NUM>) of the wound (<NUM>), the first anchor (<NUM>) is positioned on the first side (<NUM>) of the wound (<NUM>), and the body (<NUM>) extends through tissue of the wound (<NUM>).