CROSS REFERENCES TO RELATED APPLICATIONS

This application claims priority to commonly owned U.S. Provisional Patent Application Serial No. 62/675,178, entitled: Coiled Tendon Connector, filed on May 23, 2018, the disclosure of which is incorporated by reference in its entirety herein.

FIELD OF THE INVENTION

The present invention relates to connectors for body tissues, in particular to connectors for tendons.

BACKGROUND OF THE INVENTION

A tendon is a band of fibrous connective tissue that usually connects muscle to bone and is capable of withstanding tension. A normal tendon is shown, for example, in FIG. 1A. When tendons tear, either fully or partially (a full tear shown, for example in FIG. 1B), they need to be repaired surgically.

In a conventional tendon repair operation, the surgeon makes at least one cut through the skin in the area above the injured tendon so they can see the tendon and look for injuries. The surgeon then removes any damaged tendon tissue. Next, the torn ends of the tendon are sewn back together. The connection of the tendon ends is made with conventional sutures by conventional suturing techniques. With the tendon reconnected, the surgeon sews the cut skin back together with medical stitches, and the wound is covered. Additionally, a splint or similar dressing may be applied to the body outside and proximate to the tendon repair site, in order to reduce tension on the tendon while it heals.

SUMMARY OF THE INVENTION

The present invention is directed to a coiled connector and system of these coiled connectors, for connecting tissues such as tom, severed, or mptured tendons. Typically, two connectors are coupled, for example, by being joined together, to connect severed or torn ends of the tendon. With the connectors with tendon ends joined or conjugated together, a net is placed over the connected tendon, e.g., the conjugated ends thereof, to provide additional securement of the tendon ends together and allow for reconnection, for example, by providing a compression force on the conjugated tendon ends.

Embodiments of the invention are directed to a tissue connection system. The tissue connection system comprises: a first connector comprising a coiled body for receiving tissue, and terminating in an attachment member for attaching to a corresponding attachment member of a second connector; and, a second connector comprising a coiled body for receiving tissue and terminating in an attachment member for attaching to the attachment member of the first connector.

Optionally, the tissue connection system is such that the attachment member of the first connector and the attachment member of the second connector are configured to attach in a connection such that the first connector and the second connector join in a substantially straight alignment.

Optionally, the tissue connection system is such that the attachment member of the first connector and the attachment member of the second connector include correspondingly configured hook portions.

Optionally, the tissue connection system is such that for each of the first connector and the second connector, the attachment member is at one end of the coiled body and a sharpened portion is at the other end of the body, oppositely disposed from the end including the attachment member.

Optionally, the tissue connection system is such that the sharpened portion includes a barb.

Optionally, the tissue connection system is such that the coiled body of the first connector and the second connector is in at least one of a helical or corkscrew shape.

Optionally, the tissue connection system is such that it additionally comprises: a net for placement over the connection between the first connector and the second connector to secure the connection between the first connector and the second connector. Optionally, the tissue connection system is such that the net is movable from an open position, for placement over the connection, to a closed position for the reinforcement of the connection.

Optionally, the tissue connection system is such that the net includes a flexible mesh.

Optionally, the tissue connection system is such that the flexible mesh includes a shape memory retaining material, for example, Nitinol®.

Optionally, the tissue connection system is such that the flexible mesh includes at least one of metal or plastic.

Optionally, the tissue connection system is such that the first connector and the second connector include a shape memory material, for example, Nitinol®.

Optionally, the tissue connection system is such that the first connector and the second connector include at least one of metal or plastic.

Embodiments of the invention are directed to a method for connecting tissue. The method comprises: providing a tissue connector apparatus comprising: a first connector comprising a coiled body for receiving tissue, and terminating in an attachment member for attaching to a corresponding attachment member of a second connector; and, a second connector comprising a coiled body for receiving tissue and terminating in an attachment member for attaching to the attachment member of the first connector. Tissue is then attached to the first connector and the second connector. The first connector is joined or coupled to the second connector at the respective attachment members, the location of the joining or coupling of the first connector to the second connector defining a junction.

Optionally, the method is such that it additionally comprises: placing a net over the junction such that the net provides a compression force to the tissue.

Optionally, the method is such that the tissue includes a tendon.

Embodiments of the invention are directed to another method for connecting tissue. The method comprises: providing a tissue connector apparatus comprising: a first connector comprising a coiled body for receiving tissue, and terminating in an attachment member for attaching to a corresponding attachment member of a second connector; and, a second connector comprising a coiled body for receiving tissue and terminating in an attachment member for attaching to the attachment member of the first connector. Next, the method includes joining the first connector to the second connector at the respective attachment members, the location of the joining of the first connector to the second connector defining a junction; and, attaching tissue to the first connector and the second connector.

Optionally, this other method is such that it additionally comprises: placing a net over the junction such that the net provides a compression force to the tissue.

Optionally, this other method is such that the tissue includes a tendon.

Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments of the present invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

Attention is now directed to the drawings, where like reference numerals or characters indicate corresponding or like components. In the drawings:

FIG. 1 A is a photograph of a healthy and normal tendon;

FIG. 1B is a photograph of a completely torn or severed tendon;

FIG. 2 A is a perspective view of a connector in accordance with embodiments of the invention; FIGs. 2B-1 and 2B-2 are side views of the connector of FIG. 2A;

FIG. 2C is a detailed view of the proximal end of Section AA of FIG. 2B-1 ;

FIG. 2D is a front view of the proximal end of the connector;

FIG. 2E is a detailed view of the distal end of Section BB of FIG. 2B-2;

FIG. 3A is a perspective view of two connectors joined in accordance with embodiments of the invention;

FIGs. 3B-1 and 3B-2 are side views of the connectors of FIG. 3 A;

FIG. 3C is a detailed view of an a Section CC, a joined area or junction of the proximal portions of the joined connectors of FIG. 3B-2;

FIG. 4 is a perspective view of a net of the connection system;

FIG. 5 A is a diagram of an initial portion of a process performed using the connection system in accordance with an example embodiment of the invention;

FIG. 5B is a diagram of a portion of a process connecting tissue in accordance with the embodiment of the invention; and,

FIG. 5C is a diagram of a portion of a process connecting tissue and securing the connection in accordance with the embodiment of the invention.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 2A shows a perspective view and side views (FIGs. 2B-1 and 2B-2) of a connector 100 in accordance with embodiments of the invention. The connector 100 is, for example, a coil, such as a wire coil, with a body 104. The body 104 terminates in a proximal end 110, and an oppositely disposed distal end 112. A longitudinal axis (LA) extends through the connector 100. The body 104 is, for example, coiled in a corkscrew or helical shape, in either a left or right (clockwise or counterclockwise) coil orientation.

Turning also to FIG. 2B-1, FIG. 2C, and FIG. 2D, the proximal end 110 is formed of a hook portion 114. This hook portion 114 is, for example, in a“C” shape, and includes an area H4a, designed to receive a correspondingly shaped and dimensioned hook portion 114, on another connector 100, as shown, for example, in FIG. 3A. Alternately, the hook portion H4a may be a circular or other rounded or angled portion, provided it can receive a corresponding hook portion 114 or the like on another connector 100, to join (couple) the connectors 100 in an engaged manner, as shown, for example, in FIG. 3A. The hook portions 114 are, for example, of a tolerance that there is a frictional engagement between the hook portions 114, such that the engagement results in the joined connectors 100 being at least in a straight or substantially straight alignment, with respect to each other.

Turning to FIGs. 2B-2 and 2E the distal end 112 is formed of a barb or sharpened portion 116. The barb 116 receives a tissue end, such as a tendon end and allows for the tendon portion to be moved proximally, (for receipt) along the coiled body 104, toward the hook portion 114 (where advancement typically terminates). This proximal movement includes, for example, twisting the tendon portion on the connector 100 (while moving the tendon portion (e.g., tendon end) proximally).

The connector 100 is, for example, of a metal wire or plastic member, which is a surgical grade material. Metals include shape memory retaining metals, such as Nitnol®, or stainless steel, or other inert metals, such as Titanium. The material of the connector 100, may be flexible or rigid, but when two connectors 100 are joined or otherwise coupled to form a connector apparatus 120 (FIG. 3A), the joined connectors 100 maintain a straight or substantially straight alignment, which may also, but does not have to, be in a coaxial or substantially coaxial alignment.

FIGs. 3A-3C, to which attention is also directed, shows two connectors 100 joined together by an engagement of their respective hook portions 114 at the respective proximal ends 110. The joined connectors 100 form a connector apparatus (or apparatus) 120 of a system (when alone or combined with the net 200 of FIG. 4). The connectors 100 are for example, coiled in right or left handed coils. The joinder is such that the connectors 100 are oriented and maintain a straight or substantially straight alignment, which may be, a coaxial or substantially coaxial alignment, with respect to each other. As shown in FIG. 3C, in Section CC of FIG. 3B-2, the respective hook portions 114 engage each other in a perpendicular or a substantially perpendicular orientation, at a junction 130 between connectors 100 of the apparatus 120. FIG. 4 shows a net or sleeve 200, which secures the joined connectors 100. The net 200 is shown in an open position, prior to its being closed around tissue, e.g., tendon, ends joined together by joined connectors 100. The net 200 is, for example, a cylinder or tube, of a circular or rounded cross section, although other cross sectional shapes, such as rectangular, triangular, rounded, or combinations thereof are also permissible. The net 200 is formed of a wire mesh frame 202, to be, for example, flexible. The frame 202 of the net 200 is, for example, is formed of segments 204, connected at joints 206. The ends of the segments 204 may be brought together, to close the net 200 or sleeve around the connected tissue ends held by the connectors 100, as a rod end 210 engages a recessed end 211 (formed by a C-shaped recess), to close the segments 204. Other segment 204 ends are aperture ends 214. When the apertures 2l4a of the respective aperture ends 214 of a segment 204 are aligned, the ends 214 may be joined by pins or the like (not shown), which extend through the apertures 2l4a, to close the respective segments 204.

The net 200 may also include aperture protmsions 220, with apparatus 220a for accommodating pins and the like, to further secure the net 200 to the tissue it surrounds. There may also be spikes 222 protruding from the net 200 for gripping the tissue and further securing the connection of the connectors 100. Additional members for gripping tissue include hooks, barbs and the like. The spikes 222, hooks and barbs may be positioned on the net 200 in any desired orientation, so as to grip tissue, and maintain the tissue in a secured manner.

The net 200 is, for example, an integral member, but may be made of segments 204 joined together by welds at joints 206. The net 200 is formed, for example, of a flexible and elastically deformable metal, such as Nitinol® or other medical grade metal or plastic.

The connectors 100 and/or the net 200 may be coated with dmgs, compounds, lubrication agents, and combinations thereof. The connectors 100 and the net 200 define a system (apparatus) for connecting tissues, such as tendons, ligaments, vessels (blood, lymph and the like), nervous tissue, organs, and the like. In optional embodiments, only the connectors 100 need to be used. The system of the connectors 100 and the net 200 may be applied for both human, veterinary, including equine, or other animal use. FIGs. 5A-5C detail an exemplary operation for the system of the invention to join or conjugate ends of a severed or otherwise ruptured or torn tendon. In FIG. 5A two ends of a severed tendon

300, 301 are about to be attached to a respective connector 100.

The tendon ends 300, 301 are attached to the respective connector 100 by being advanced from the distal end 112 to the proximal end 110 by twisting the tendon end 300, 301, along the coiled body 104 of the respective connector 100. The advancement is such that each tendon end 300, 301 is received by the respective coiled body 104 (of each connector 100) and moved along the body 104 proximally, to at least to the hook portion 114 of the connector 100. The hooked portions 114 are then engaged, such that the connectors 100 (with their tendon ends 300, 301) are joined to form a connector apparatus 120, as shown in FIG. 5B. The hooked portions 114 engage at the junction 130 of the apparatus 120 (FIG. 3B-2). Alternately, the tendon ends 300, 301 may be attached to the respective connector 100, as detailed immediately above, after the connectors have been joined (engaged), to form the connector apparatus 120, as shown in FIG. 5B. The connectors 100 are inside of the respective tendons 300, 301. The tendon ends 300, 301 are, for example, in physical contact with each other so as to be joined or conjugated.

A net 200, in an open position, as shown in FIG. 4, is brought over the joined tendon ends 300,

301, for example, with at least a portion of the net 200 over the junction 130. The segment ends 210, 211, 214 are brought together, so that the net 200 has moved from the open position, to a closed position, as shown in FIG. 5C. The net 200 provides further securement to the conjugated tendon ends 300, 301 and the joined connectors 100. The net 200 may serve to provide a radially inward compression force or clamping force on the tendon ends 300, 301. This compression or clamping force augments contact of the tendon ends 300, 301 with each other, for joining and conjugating the tendon ends 300, 301. Optionally, when the tendon is considered to be healed by a medical professional or the like, the net 200 may be removed.

While a tendon was shown in operation with the connectors 100 and the system, other tissues, including, for example, ligaments, vessels (blood, lymph, and the like), nervous tissue, organs, and the like, may also be used with the disclosed system in accordance with the above methods.

Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.