WO2016033647A1

WO2016033647A1 - A device and method for tendon surgery

Info

Publication number: WO2016033647A1
Application number: PCT/AU2015/050511
Authority: WO
Inventors: Nicholas Smith
Original assignee: Allegra Orthopaedics Limited
Priority date: 2014-09-02
Filing date: 2015-09-01
Publication date: 2016-03-10

Abstract

Devices and methods for separating a tendon are disclosed. A device has an elongate body, a locator member which forms a protrusion relative to the elongate body and attachment means to attach a separating member thereto. The device is inserted through a tendon sheath from a first incision to a second, spaced incision, to cause the separating member to separate the tendon.

Description

A Device and Method for Tendon Surgery

Priority Details

The present application claims priority from Australian provisional application number 2014903505, the contents of which are herein incorporated by reference.

Technical Field

The present disclosure relates to a device and a method for use in separating a tendon of a patient.

Background

Surgical reconstructions using tendon transfers are aimed to restore function in the upper or lower extremities. This loss of function may be caused by nerve damage, traumatic injury, neurological disorders and/or surgical removal of bony tissues.

During a tendon transfer, a tendon either located sufficiently close to the site of damage or from another site is partially split into two sections, one of which is then cut near its insertion point. This detached tendon section is then rerouted through surrounding soft tissues around or between the bones and attached to another tendon or bone while still connected to its parent muscle.

As tendons transfer and passively modulate forces by redirecting muscular force, movement of the previously dysfunctional body part is restored. In certain cases where a sufficiently long section of resected tendon is available, it can be threaded through tunnels created in the bones and/or surrounding tissue and re-attached to itself in either an arthroscopic or open surgical procedure.

Tendons typically used in tendon transfer in the extremities include the flexor carpi radialis (FCR), flexor carpi ulnaris (FCU), flexor digitorum profundus (FDP), flexor digitorum superficialis (FDS), posterior tibial tendon (PTT), flexor hallicus longus (FHL), flexor digitorum longus (FDL) and the Achilles tendon. A traditional method of resecting the tendon for tendon transfer involves using a tendon passer or pituitary rongeur. First, an incision is created in a patient's skin and the required tendon identified and sheath opened. A skin mark is made identifying the length of tendon required for the procedure. The pituitary rongeur is passed along the tendon, within the tendon sheath, from the first incision until the tip of the rongeur is felt beneath the skin marking. This identifies where the second incision is made. The pituitary rongeur is passed through this second incision and used to grasp a first fine wire which is drawn back through the tendon sheath exiting at the first incision. A split is made in the tendon at the first incision site and another fine wire passed through this split. This second wire is then joined to the first wire and pulled back through the second incision. As the second wire is pulled through, the tendon is split

longitudinally.

A clear disadvantage of this method is that the surgical tools are passed back and forth several times through the sheath during a number of steps of the procedure. In order to preserve functionality of the tendon and minimise healing time, minimal damage should be caused to the tendon and surrounding tissues during tendon resection. There is, therefore, a need for a minimally invasive method and device to separate a tendon.

Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present disclosure as it existed before the priority date of each claim of this application.

Summary

In one aspect of the present disclosure, there is provided a device for use in separating a tendon comprising an elongate body extending from a first end to a second end along a main axis and a locator member at or adjacent to the second end of the elongate body, the locator member forming a protrusion relative to the main axis of the elongate body said elongate body further including attachment means to attach to a tendon separating member wherein the elongate body and the locator member are configured to pass through a tendon sheath of a patient from a first incision to a second incision and to be removed from a patient through said second incision such that a tendon separating member attached to the attachment means is passed through said tendon sheath from the first incision to said second incision.

The term "separating a tendon" is intended to include cutting, splitting, dividing or partially or fully removing a tendon of a subject.

In a further aspect of the present disclosure, there is provided a device for use in cutting a tendon comprising an elongate body extending from a first end to a second end along a main axis and a locator member at or adjacent to the second end of the elongate body, the locator member forming a protrusion relative to the main axis of the elongate body said elongate body further including attachment means to attach to a tendon cutting member wherein the elongate body and the locator member are configured to pass through a tendon sheath of a patient from a first incision to a second incision and to be removed from a patient through said second incision such that a tendon cutting member attached to the attachment means is passed through said tendon sheath from the first incision to said second incision.

In another aspect of the present disclosure, there is provided a method of separating a tendon including:

making a first incision in the skin of a patient to expose a tendon to be separated;

incising the tendon to create an opening therein to receive a tendon separating member;

providing a device comprising an elongate body extending from a first end to a second end along a main axis and a locator member at or adjacent to the second end of the elongate body, the elongate body further including attachment means to attach to the tendon separating member;

inserting the second end of the elongate body through the first incision and into a tendon sheath surrounding the tendon;

passing the elongate body through the tendon sheath and away from the first incision;

identifying a desired location of the second end of the elongate body by identifying the position of the locator member;

threading the separating member through the opening in the tendon and attaching said separating member to the attachment means of the elongate body;

making a second incision in the skin of the patient at a location relative to the locator member;

passing the elongate body and separating member through the second incision; applying a force to the elongate body and/or the separating member to cause the tendon to be separated.

In another aspect of the present disclosure, there is provided a method of cutting a tendon including:

making a first incision in the skin of a patient to expose a tendon to be cut; incising the tendon to create an opening therein to receive a tendon cutting member;

providing a device comprising an elongate body extending from a first end to a second end along a main axis and a locator member at or adjacent to the second end of the elongate body, the elongate body further including attachment means to attach to the tendon cutting member;

threading the cutting member through the opening in the tendon and attaching said cutting member to the attachment means of the elongate body;

passing the elongate body and cutting member through the second incision; applying a force to the elongate body and/or the cutting member to cause the tendon to be cut.

In a further aspect of the present disclosure, there is provided a tendon delivery device, the tendon delivery device comprising an elongate body extending from a first end to a second end along a main axis and including attachment means to attach the tendon thereto wherein the elongate body is configured to pass through a region of a patient such part of the tendon is positioned for resection to part of the patient's body.

The tendon may be attached to the device by way of any suitable means. For example, the tendon may be sewn to the device by suture thread. The suture thread may loop through apertures in the tendon delivery device, details of which are provided below.

Alternatively, a connector may be connected to the tendon delivery device. The connector may comprise a mesh member, a portion of which connects to part of the tendon delivery device. A spaced portion of the mesh structure may connect to the tendon. The mesh structure may grip the tendon. In one embodiment, as a length of the mesh structure is extended, the portion of the mesh connecting the tendon, tightens around the tendon to grip the tendon. In this embodiment, the connector member may comprise a cylindrical, helically wound braid which decreases in circumference as it is stretched, to thereby tighten and grip around the tendon.

The tendon delivery device of this aspect may further include a locator member at or adjacent to the second end of the elongate body, the locator member forming a protrusion relative to the main axis of the elongate body.

The tendon may comprise a tendon or part of a tendon taken from another part of the body using the device for separating or cutting a tendon described above.

Alternatively, the tendon may include an artificial tendon or a tendon taken from another animal or human. The tendon may be passed through any part of the body of a patient when attached to the device including through an incision, or a skin portal during an arthroscopic procedure, through a bone tunnel formed during a surgical procedure, soft tissue or other anatomical structure, including the pulley mechanism of the flexor tendons in a hand of a patient.

The following description relates to features of the devices of any of the above aspects. The term "device" is used to cover both devices for separating or cutting a tendon and the tendon delivery device.

A majority of the elongate body of the abovementioned devices may be substantially straight along its length. Such a configuration allows for a relatively streamlined passing of the device through the tendon sheath. Alternatively, the elongate body may be curved along its length.

In one embodiment, the entire elongate body including the first end comprising the attachment means is substantially cylindrical, having a circular cross section.

In another embodiment, the cross section of the elongate body of the device of any of the above aspects may be square, triangular, rectangular or ovoid.

Alternatively a region of the first end comprising the attachment means may have a different shape to that of the remainder of the elongate body. In one

embodiment, the region comprising the attachment means may be substantially flattened relative to the remainder of the elongate body. Such flattening of this region may aid in gripping the first end of the elongate body during use and during attachment of the cutting member to the attachment means.

The diameter of the elongate body may be uniform along its length.

Alternatively, the diameter of the elongate body may vary along its length. In one embodiment, the elongate body may taper towards either or both the first and/or second end. Alternatively, the elongate body may flare outwardly at one or both of the first and/or second ends.

The diameter of the elongate body is selected depending upon the tendon to be separated and in some embodiments this will depend upon the size of the patient. In one embodiment, the diameter of the elongate body is approximately 4mm. In other embodiments, the diameter may be approximately 2mm, 3mm, 5mm or 6mm.

In one embodiment, an outer surface of the elongate body may be configured to provide a reduced friction surface area for contact with the surrounding tendon sheath. For example, the material from which the elongate body is made may have a relatively low friction coefficient. Example of suitable materials include stainless steel, titanium, Nitinol, high density polyethylene, a polyphenylsulfone such as marketed under the trade name "Radel", nylon, polypropylene, acrylic or polycarbonate.

In another embodiment, a reduced friction coefficient and/or improved wettability of an outer surface may be achieved by a coating over at least a region of the elongate body outer surface. For example, at least a region of an outer surface adjacent the second end of the elongate body may be coated with a suitable coating to reduce friction as the elongate body is advanced through the tendon sheath.

Alternatively, a majority or all of the elongate body may be coated with a suitable coating having a low friction coefficient. Examples of coatings include but are not limited to metallic coatings, such as Chrome, polymeric hydrophilic or hydrogel coatings or ceramic physical vapour deposition coatings such as TiN.

A coating material may be applied to the outer surface of the elongate body by a number of means including spraying, dipping, polymerisation, painting or

electroplating.

The elongate body may include one or more radio-opaque markers. In this embodiment, the material of the elongate body may be doped or coated with radio- opaque materials including, but not limited to gold or platinum. Alternatively, the elongate body may be made entirely or at least partially from a radio-opaque material. Examples of suitable materials for the latter embodiment include a metal or metal alloy including but not limited to stainless steel, titanium or Nitinol.

In one embodiment, the separating/cutting member comprises an elongate cutting member which is fed through the incision made in the tendon and looped back on itself to form a cutting apex through the tendon and two legs extending away from the tendon to free ends.

The cutting member may be of sufficient length such that the legs extend the desired length of the tendon to be cut. Preferably the length of the legs is sufficient to extend from the first incision to the second incision as described in the above method.

The length of the cutting member may be between 15cm and 20cm. In one embodiment, the length of the cutting member may be approximately 20cm, 21cm, 22cm, 23cm, 24cm, 25cm, 26cm, 27cm, 28cm, 29cm or 30cm. The length of the cutting member may be approximately double the length of a tendon to be cut.

The attachment means may be located at either end or at any point along its length. The attachment means may comprise one or more engagement regions for retaining the cutting member during use.

Preferably, the attachment means provides a guide for the legs of the cutting member such that as the elongate body is passed through the tendon sheath, the legs of the cutting member travel with the elongate body along the tendon sheath.

In one embodiment, the attachment means may comprise one or more apertures, slots or cut-away through the elongate body.

In another embodiment, the attachment comprises two apertures in the elongate body adjacent the first end. The apertures may be positioned along the same axis of the elongate body and spaced relative to each other. Alternatively, the apertures may be offset relative to one another or may be positioned at either end of the elongate body or at any point along its length. The apertures are typically suitably sized to receive the ends of a cutting member. The diameter of the apertures may be approximately 1.5mm; 1.6mm 1.7mm, 1.8mm 1.9mm, or 2.00mm. The diameter of each aperture may be less than 1.5mm in embodiments wherein the cutting member is relatively thin. For example, the diameter of the apertures may be from approximately 1.0mm to approximately 1.5mm. Still further, the apertures may have a diameter of less than 1mm, for example 0.5mm, 0.6mm, 0.7mm, 0.8mm, or 0.9mm.

The legs of the cutting member may be threaded through a single aperture or alternatively each leg may be passed through a separate aperture. Typically, a user pulls the free ends of the cutting wire through the one or more apertures until they are relatively taut. When the elongate body is moved through the tendon sheath and away from the cutting apex in the incised tendon, the legs essentially travel through the aperture(s) and are pulled through the tendon sheath until a region of each leg adjacent the free ends is exposed at the second incision of the above method. Preferably the legs are pulled from the second incision of the above described method and thus allow a user to grip the cutting member by the legs.

In another embodiment, the attachment means may comprise fingers defining slots therebetween. In this embodiment, the fingers may be spaced to define one or more slots to receive the legs of the cutting member. In an embodiment wherein the attachment means comprises two fingers defining a single slot, the fingers may be spaced to receive the cutting member and may engage the legs of the cutting member. The engagement of the fingers and the legs of the cutting member may be a frictional engagement sufficient to prevent disengagement of the cutting member from the elongate body while allowing travel of the legs between the fingers as the cutting member is guided through the tendon sheath by passage of the elongate body therethrough.

Alternatively, the attachment means may comprise multiple fingers defining multiple slots therebetween. In this embodiment, each leg of the cutting member may be woven over and under the fingers. The engagement in this embodiment is also sufficient to prevent disengagement of the cutting member from the elongate body while still allowing travel of the legs through the fingers as the cutting member is guided through the tendon sheath by passage of the elongate body therethrough. The attachment means may comprise a clip to frictionally engage the legs of the cutting member. The clip may extend from one end of the elongate body or alternatively from any part of the elongate body along its length. The clip extends along a clip length which is substantially parallel to the elongate body. The clip may be spring-loaded or otherwise biased relative to elongate body. The spacing of the clip relative to the elongate body is such as to allow a separating member to pass therethrough. In one embodiment, the engagement between the clip and the legs of the cutting member may be sufficient to prevent disengagement of the cutting member from the elongate body while still allowing travel of the legs through the clip as the cutting member is guided through the tendon sheath by passage of the elongate body therethrough.

The apertures or slots described may further comprise a friction flange to engage the separating member/cutting member. Such an engagement while still allowing travel of the legs of the separating/cutting member through the aperture or slots further prevents disengagement of the separating/cutting member from the elongate body as they are passed through the tendon sheath.

The attachment means may further comprise a flap in the outer wall of the elongate body. The flap typically defines a slotted space to receive the legs of the separating/cutting member and allow the legs to travel across the slot as the elongate body is moved through the tendon sheath.

The separating/cutting member may comprise a length of surgical thread or wire suture. The separating/cutting member may be made from a number of nonabsorbable materials such as polypropylenes, polyamides, polyesters and silk. In another embodiment, the separating/cutting member may be made from an absorbable materials including polyglycolic acid sutures, polyglactin 910, catgut, and

polydioxanone. Alternatively, the wire suture may be made of biocompatible metal. An example includes stainless steel. The separating/cutting member may also comprise a Nitinol wire. The separating/cutting member is typically sufficiently strong under tension such that the tendon is cut without the separating/cutting member breaking.

In a further embodiment, the separating/cutting member may be secured to the attachment means and extend therefrom to provide a cutting surface. In this embodiment, the separating/cutting member may comprise a hook member having a cutting surface. The hook member may extend substantially perpendicularly from the attachment means of the device and relative to the main axis of the elongate body. The hook member typically extends from an attachment end, which is secured to the attachment means, to a free anchoring end, said cutting surface extending

therebetween. Other structures are envisaged to provide a cutting surface which may be moved with the elongate body of the device to cut the tendon.

The hook member or other structure may be formed from a biocompatible material e.g. medical grade stainless steel or a polymeric material with a suitably sharp cutting surface. Additionally, all parts of the hook member that do not comprise the cutting portion may be substantially blunt or rounded to prevent damaging other parts of the tendon and/or sheath during passage of the elongate body through the tendon sheath.

In a further embodiment, the attachment means may comprise a length of thread or wire attached to a portion of the elongate body, the length of wire or thread extending from a fixed end which is fixed to the elongate body, to a free end. The wire or thread may then be looped through an incision in a tendon and secured either to itself adjacent the fixed end or to a region of the elongate body. In this embodiment, a "cutting loop" is formed which cuts the tendon when the elongate body is pulled from the second incision.

The locator member, as described, provides a protrusion relative to the main axis of the elongate body. The locator member may comprise a locator tip extending from the second end of the elongate body at an angle relative to the main axis of the elongate body. In use, the locator member typically provides a visual or manual marker of its location beneath the skin of the patient. Typically, the locator member is uniform with the elongate body and forms an angled locator tip extending from the second end of the elongate body.

In another embodiment, the locator member may comprise a protrusion extending from an outer wall of the elongate shaft, typically spaced from but adjacent to the second end of the elongate body. The protrusion may take a variety of shapes e.g. a rounded protrusion, a frusto-conical protrusion or a cuboid protrusion.

The locator member is typically sized and shaped such that its profile is viewable or palpable through the skin of a patient when the device is moved through a tendon sheath and such that a medical practitioner can track the positioning of the device.

In one embodiment, the locator tip may be a substantially curved structure. Alternatively, the locator tip may be substantially straight and extend at an angle to the elongate body from the second end.

The locator tip may be continuous with the elongate body. Further, the locator tip may have the same cross-section as the elongate body. In one embodiment the locator tip and the elongate body may be of unitary construction. Hence, the locator tip and elongate body may be formed using the same manufacturing process.

The locator tip typically has smoothed edges in order to prevent rupturing of the tendon sheath and to minimise other damage to surrounding tissues. Furthermore, a height of the locator tip relative to the remainder of the elongate body may be sized such as to fit within the tendon sheath without causing damage to or rupture of the tendon sheath.

In another aspect, there is provided a device for use in separating a tendon comprising an elongate body extending from a first end to a second end along a main axis and a locator member at or adjacent to the second end of the elongate body, the locator member forming a protrusion relative to the main axis of the elongate body said elongate body further including attachment means to attach to a tendon separating member wherein the elongate body and the locator member are configured to pass through a tendon sheath of a patient from a first incision;

wherein said locator member includes a tendon separating member to separate the tendon as the elongate body is moved through the tendon sheath

In a further aspect of the present disclosure, there is provided a device for use in cutting a tendon comprising an elongate body extending from a first end to a second end along a main axis and a locator member at or adjacent to the second end of the elongate body, the locator member forming a protrusion relative to the main axis of the elongate body said elongate body further including attachment means to attach to a tendon cutting member wherein the elongate body and the locator member are configured to pass through a tendon sheath of a patient from a first incision wherein said locator member includes a tendon cutting member to cut the tendon as the elongate body is moved through the tendon sheath.

The separating or cutting members of the above aspect may also cut the skin of a patient at a second incision spaced from said first incision so that the elongate body may be removed through the second incision.

The elongate body typically has sufficient stiffness insertion into the tendon sheath and to substantially withstand bending when a force is applied to pass it through the tendon sheath.

The device may be manufactured from a range of biocompatible materials, which can be sterilized using a variety of sterilization methods. Medical grade stainless steel, medical grade aluminium or titanium alloy are suitable metallic materials for use in construction of the elongate body. Medical grade plastics such as Radel, nylon, high density polyethylene, polypropylene, acrylic or polycarbonate may be used. The elongate body and the locator tip may be made of the same or a different material.

The locator member may protrude from an upper surface of the elongate body by up to approximately 12mm. Particularly, the height of the locator member may be in the range of from 4mm to 12mm, or 6mm to 10mm, or 8mm to 10mm from the upper surface of the elongate body. The protrusion may extend approximately 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm or 12 mm from the upper surface of the elongate body.

The elongate body may comprise a solid structure. Alternatively, the elongate body may be substantially tubular. The elongate body may be partially tubular and partially solid.

The length of the elongate body may be adjustable. In one embodiment, the elongate body may comprise a plurality of telescopically arranged tubular segments to allow for such length adjustment.

Further, it is envisaged that the length of the elongate body of the device may be increased by adding another segment or decreased by removing a segment.

The tubular body may include a lumen extending from the first end to the second end. The lumen may receive a wire or other member therethrough. In one embodiment, such a wire or other member may cut the skin at a desired location to form the second incision. It is further envisaged that a wire or other member passed through the lumen of the elongate body may cut the tendon as the elongate body is passed through the tendon sheath.

The total length of the device may be 10 cm, 11cm, 12cm, 13cm, 14cm, 15 cm, 16cm, 17cm, 18cm, 19cm or 20 cm.

Embodiments of the Invention.

Embodiments of the invention are provided in the following numbered paragraphs:

1. A device for use in separating a tendon comprising:

an elongate body extending from a first end to a second end along a main axis; and

a locator member at or adjacent to the second end of the elongate body, the locator member forming a protrusion relative to the main axis of the elongate body; said elongate body further including attachment means to attach a tendon separating member ;

wherein the elongate body and the locator member are configured to pass through a tendon sheath of a patient from a first incision to a second incision and to be removed from a patient through said second incision such that a tendon separating member attached to the attachment means is passed through said tendon sheath from the first incision to said second incision.

2. The device of paragraph number 1, wherein the elongate body is substantially straight along its length.

3. The device of paragraph number 1 or paragraph number 2, wherein the elongate body comprises an upper surface and an opposed lower surface each of which extends from the first end to the second end, the upper and lower surfaces spaced relative to each other by connecting sidewalls, the sidewalls defining a height of the elongate body.

4. The device of paragraph number 3, wherein the attachment means is located adjacent to the first end of the elongate body.

5. The device of paragraph number 4, wherein an attachment length of the elongate body comprising the attachment means has a relatively reduced height and/or width in relation to the remainder of the elongate body.

6. The device of any one of the preceding paragraphs wherein the elongate body is made from any one of the materials including stainless steel, titanium, Nitinol, high density polyethylene, a polyphenylsulfone, nylon, polypropylene, acrylic or polycarbonate.

7. The device of any one of the preceding paragraphs wherein at least part of the elongate body and/or the locator member includes a coating. 8. The device of paragraph number 7, wherein the coating is selected from one or more of metallic coatings, polymeric hydrophilic or hydrogel coatings or ceramic physical vapour deposition coatings.

9. The device of any one of the preceding paragraphs, further including one or more radio-opaque markers.

10. The device of any one of paragraph numbers 3 to 9, wherein the attachment means comprises one or more apertures extending from an opening formed in the upper surface of the elongate body to an opening formed in the lower surface of the elongate body.

11. The device of paragraph number 10, wherein at least part of the circumference of the opening in or adjacent to the upper and/or lower surfaces of the elongate body may include an inwardly extending flexible flange to frictionally engage at least part of the separating member as it passes through the aperture.

12. The device of paragraph number 10 or paragraph number 11 wherein the one or more apertures are spacedly aligned relative to each other along the main axis of the elongate body.

13. The device of any one of paragraph numbers 1 to 11, wherein the attachment means comprises a plurality of fingers which define slots therebetween, the slots dimensioned to receive at least part of the separating member.

14. The device of any one of the preceding paragraphs, wherein the separating member includes an elongate cutting thread or suture which is suitably flexible to be threaded through or onto the attachment means of the device.

15. The device of paragraph number 14, wherein the separating member is selected from any one or more of non-absorbable materials such as polypropylenes, polyamides, polyesters and silk; absorbable materials including polyglycolic acid sutures, polyglactin 910, catgut, and polydioxanone or a biocompatible metal including stainless steel or Nitinol wire. 16. The device of paragraph number 14 or paragraph number 15, wherein the attachment means comprises first and a second apertures and wherein one end of the cutting thread or suture is threadable through the first aperture and the second end is threadable through the second aperture.

17. The device of any one of the preceding paragraphs, wherein the elongate body extends along the main axis and the locator member comprises a locator tip extending from the second end of the elongate body along a second axis which is different to the main axis.

18. The device of paragraph number 17, wherein the second axis is at an angle relative to the main axis, said angle being between 20° and 70°.

19. The device of paragraph number 18, wherein the angle is between 20° and 40°.

20. The device of any one of paragraph numbers 3 to 16, wherein the locator member is spaced from the second end of the elongate body and extends outwardly from the upper surface of the elongate body.

21. The device of paragraph number 20, wherein the locator member comprises a protrusion extending along an axis which is substantially perpendicular to the main axis of the elongate body.

22. The device of paragraph number 20, wherein the locator member comprises a protrusion extending along an axis which is at an angle of between 20° and 70° relative to the main axis of the elongate body.

23. The device of paragraph number 20, wherein the locator member comprises a protrusion extending along an axis which is at an angle of approximately 30°.

24. A method of separating a tendon including:

25. The method of paragraph number 24, wherein the separating member comprises a cutting thread or suture extending from one end to a second end.

26. The method of paragraph number 25, comprising threading the one end of the cutting thread or suture through the opening incised in the tendon and feeding the thread or suture through the opening and around an edge of the tendon.

27. The method of paragraph number 26, wherein the attachment means comprises two apertures formed in the elongate body, said apertures extending from an opening in an upper surface of the elongate body to an opening in the lower surface of the elongate body and the method comprises threading the one end of the thread or suture through one aperture and the second end of the thread or suture through the second aperture. 28. A device for use in separating a tendon comprising:

a locator member positioned at or adjacent to the second end of the elongate body, the locator member forming a protrusion relative to the main axis of the elongate body;

said elongate body further including a tendon separating member ;

wherein the elongate body and the locator member are configured to pass through a tendon sheath of a patient from a first incision to a second incision and to be removed from a patient through said second incision such that the tendon separating member separates at least part of the tendon as the elongate body is moved through the tendon sheath.

29. The device of paragraph number 28, wherein the separating member comprises a hook extension from the first end of the elongate body, said hook extension including a cutting surface.

30. The device of paragraph number 29, wherein the hook extension is formed from a biocompatible material selected from any one of medical grade stainless steel or a polymeric material with a suitably sharp cutting surface.

31. A device for introducing a tendon or part of a tendon for resection in another location of the patient, the device comprising an elongate body extending from a first end to a second end along a main axis and including attachment means to attach the tendon or part of the tendon to the device.

32. The device of paragraph number 31, further comprising a locator member, said locator member positioned at or spaced from the second end of the elongate body.

33. The device of paragraph number 32, wherein the elongate body extends along the main axis and the locator member comprises a locator tip extending from the second end of the elongate body along a second axis which is different to the main axis. 34. The device of paragraph number 33, wherein the second axis is at an angle relative to the main axis, said angle being between 20° and 70°.

35. The device of paragraph number 32, wherein the locator member is spaced from the second end of the elongate body and extends outwardly from the upper surface of the elongate body.

36. The device of paragraph number 35, wherein the locator member comprises a protrusion extending along an axis which is substantially perpendicular to the main axis of the elongate body.

37. The device of paragraph number 35, wherein the locator member comprises a protrusion extending along an axis which is between 20° and 70 degrees relative to the main axis.

38. The device of any one of paragraph numbers 31 to 37, wherein the attachment means comprises one or more apertures extending from an opening formed in an upper surface of the elongate body and to an opening formed in an opposed lower surface of the elongate body.

39. The device of paragraph number 38, wherein the tendon or part of the tendon is attached to the device by sutures through the one or more apertures.

Throughout this specification the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps. Brief Description of Drawings

Figures 1A to 1C are side views of embodiment of the device of the present disclosure;

Figure ID is a top plan view of the embodiment of Figure 1 A;

Figure IE is a side view of another embodiment of a segmented device;

Figures 2A to 2F are partial side views of the device of further embodiments of the disclosure;

Figure 3A to 3C are partial side views of the device showing the attachment means of further embodiments of the disclosure;

Figure 3D is a partial top plan view of the device of a further embodiment of the attachment means;

Figure 4 is a schematic representation of an embodiment of the device of Figure 1C;

Figure 5 is a schematic view of a further embodiment having a cylindrical body of the disclosure;

Figure 6 is a schematic representation showing the threading of part of a cutting member through a tendon of a patient;

Figure 7 is a schematic representation showing the positioning of part of the cutting member through the attachment means of one embodiment;

Figure 8 is a schematic representation showing the positioning of part of the cutting member through the attachment means of another embodiment; Figure 9 is a schematic representation of another embodiment of an attachment means of the disclosure;

Figure 10 is a side view of the attachment means of a further embodiment;

Figure 11 is a top view depicting the positioning of part of a cutting member relative to the attachment means of the embodiment depicted in Figure 10; and

Figures 12A to 12F show the steps of cutting a tendon using the device of the present disclosure

Description of Embodiments

A device for separating a tendon is generally depicted as 10 in the

accompanying drawings. The device 10 assists in the separating of the tendon and in one particular embodiment, allows the passage of a cutting wire or thread 100 through a tendon sheath of a patient.

The device has an elongate body 11 which extends from a first end 12 to a second end 13 along a main axis (x).

The device further includes a locator member 14 at or adjacent to second end 13 of elongate body 11. The locator member 14 forms a protrusion relative to the main axis (x) such that a surgeon can see or feel it through the tendon sheath and skin during a procedure.

The elongate body of some embodiments is substantially straight as shown in, for example, Figure ID.

In Figure IE, the elongate body 11 comprises a series of segmented parts 1 la, 1 lb and 1 lc to allow the overall length to be telescopically increased or decreased.

As shown in Figure 1C, elongate body 11 may include a tapered or narrower region at its first end 12. In Figure 4, this narrowed portion may also be substantially flattened. The remainder of the elongate body also presents a more flattened profile in this embodiment having a relatively flat upper surface 16 and sidewalls 17.

The elongate body may, however, be substantially cylindrical in shape as shown in Figure 5.

Included at, or adjacent to, the first end 12 are attachment means 15 which are configured to attach the cutting wire or thread 100 to the device 10.

The cutting wire or thread 100 is, in use, threaded through an incision 51 made in a tendon 50. The wire or thread 100 is partially fed through incision 51 to form a cutting apex 101 through tendon 50 with legs 102a and 102b of the wire or thread 100 extending away from the tendon 50 to free ends.

The cutting wire or thread 100 is of sufficient length to extend the desired length of the tendon 50 to be cut.

The cutting wire or thread 100 is then attached to attachment means 15 of device 10.

As shown in the embodiment in Figure 7, the attachment means 15 comprises two apertures 18a and 18b. The legs 102a and 102b of thread or suture 100 are guided through respective apertures and pulled in direction (A) by a user to bring device 10 and tendon 50 into close approximation.

Device 10 is then manipulated through the tendon sheath of tendon 50 causing legs 102a and 102b to travel through apertures 18a and 18b respectively and thus be fed through the tendon sheath with device 10.

In the embodiment shown in Figure 8, the attachment means 15 comprises fingers 103a, 103b and 103c. The fingers together define slots 104a and 104b. Legs 102a and 102b are woven through the slots as shown and pulled in direction (B). To aid in retaining the thread or wire 100 between fingers 103a 103b and 103c, each finger may also comprise a flexible flange 104 extending from a sidewall 105. Opposed flanges 104 extending from sidewalls 105 provide a gripping interface for the thread or wire 100 while still allowing passage therethrough to allow the wire or thread 100 to be fed through attachment means 15 and through the sheath of tendon 50.

Apertures 18a and 18b may also include a circular flange 106 to better grip the wire or thread 100.

The attachment means 15 in Figure 10 comprises a flap or clip 19 in outer wall 21 of elongate body 11. Flap or clip 19 defines a space relative to the elongate body 11 to receive the legs 102a and 102b of wire or thread 100. A gripping flange 22 extends from an underside of flap or clip 19 to provide a better friction fit with legs 102a and 102b while still enabling movement of the legs between flap/clip 19 and outer wall 21.

The locator member 14 provides a protrusion relative to the main axis (x) of the elongate body 11.

In Figures 1A to ID for example, the locator member is a locator tip 23 extending from the second end 13 of elongate body 11 along an axis (y). Axis (y) is angled relative to main axis (x). The angle θ^ζ may vary depending upon the degree of protrusion required and may be somewhere between 20° and 90°, typically between 20° and 70°; or between 20° and 50°; or between 20° and 40°. In one embodiment, angle θ^ζ is approximately 30°.

As the device 10 is passed through a tendon sheath of tendon 50, the angled locator tip 23 pushes against the tendon sheath and the surrounding skin which shows as a bulge in the skin. The surgeon can then identify the position of the second end 12 of the device and make an incision accordingly.

Broadly, the steps of a procedure to separate a tendon are shown in Figures 12A to 12F.

A first incision 30 is made in the skin of a patient to expose tendon 50. A surgical tool 51 is used to raise tendon 50 and an incision 52 is made through the tendon. An end of leg 102a or 102b of the cutting wire or thread is passed through the incision and doubled back on itself as shown in Figure 12B. The result is as shown in Figure 6, the cutting wire or thread having a cutting apex 101 looped through the incision of tendon 50, with the legs trailing therefrom.

The second end 13 of device 10 is then fed through the incision and between tendon 50 and its tendon sheath. The device is advanced as shown in Figure 12D until a portion of the first end 12 of elongate body 11 is located adjacent to the portion of tendon 50 incised. The trailing legs 102a and 102b are fed into respective apertures 18a and 18b and the legs pulled relatively taut in a direction as shown by arrow (C). The surgeon optionally pushes the device 10 still further in a proximal direction until the bulge in the skin, representing the locator member, is at a desired location 53. At this stage, the surgeon makes a second incision 31 and pulls the device towards and through second incision 31.

As the elongate body 11 is moved through the tendon sheath, the legs of the wire or thread 102a and 102b travel through the apertures 18a and 18b and are fed through the sheath until they are exposed at the second incision 31 at location 53.

Once, the legs 102a and 102b extend through the second incision, the surgeon can grasp them (with or without them being attached to the elongate body), and pull in direction (D). Cutting apex 101 is then brought into forceful engagement with the edge of the incision in the tendon 50 and slices through the tendon 50 to separate the tendon 50 along its longitudinal axis.

The tendon 50 may be split longitudinally in half or separated unevenly, i.e. further towards the lateral or medial edges of the tendon 50 depending upon where the surgeon makes the incision 52.

As shown in Figure 13 A, tendon 50 may be separated into two equal or unequal lengths 50a and 50b. 50b may then be used to insert into another part of the patient's body, for example into the hand of the patient to repair a damaged tendon. In this regard, tendon part 50b may be attached to the device 10 as shown in Figure 13B by way of suturing tendon end 50c through apertures 15 in device 10. Device 10 may then be used to tunnel through tissue or a prepared bone tunnel towards another site whereupon a surgeon may attach tendon end 50c to a muscle or other part of the body as required.

It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the above-described embodiments, without departing from the broad general scope of the present disclosure. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.

Claims

CLAIMS:

1. A device for use in separating a tendon comprising:

2. The device of claim 1, wherein the elongate body is substantially straight along its length.

3. The device of claim 1 or claim 2, wherein the elongate body comprises an upper surface and an opposed lower surface each of which extends from the first end to the second end, the upper and lower surfaces spaced relative to each other by connecting sidewalls, the sidewalls defining a height of the elongate body.

4. The device of claim 3, wherein the attachment means is located adjacent to the first end of the elongate body.

5. The device of claim 4, wherein an attachment length of the elongate body comprising the attachment means has a relatively reduced height and/or width in relation to the remainder of the elongate body.

6. The device of any one of the preceding claims wherein the elongate body is made from any one of the materials including stainless steel, titanium, Nitinol, high density polyethylene, a polyphenylsulfone, nylon, polypropylene, acrylic or

polycarbonate.

7. The device of any one of the preceding claims wherein at least part of the elongate body and/or the locator member includes a coating.

8. The device of claim 7, wherein the coating is selected from one or more of metallic coatings, polymeric hydrophilic or hydrogel coatings or ceramic physical vapour deposition coatings.

9. The device of any one of the preceding claims, further including one or more radio-opaque markers.

10. The device of any one of claims 3 to 9, wherein the attachment means comprises one or more apertures extending from an opening formed in the upper surface of the elongate body to an opening formed in the lower surface of the elongate body.

11. The device of claim 10, wherein at least part of the circumference of the opening in or adjacent to the upper and/or lower surfaces of the elongate body may include an inwardly extending flexible flange to frictionally engage at least part of the separating member as it passes through the aperture.

12. The device of claim 10 or claim 11 wherein the one or more apertures are spacedly aligned relative to each other along the main axis of the elongate body.

13. The device of any one of claims 1 to 11, wherein the attachment means comprises a plurality of fingers which define slots therebetween, the slots dimensioned to receive at least part of the separating member.

14. The device of any one of the preceding claims, wherein the separating member includes an elongate cutting thread or suture which is suitably flexible to be threaded through or onto the attachment means of the device.

15. The device of claim 14, wherein the separating member is selected from any one or more of non-absorbable materials such as polypropylenes, polyamides, polyesters and silk; absorbable materials including polyglycolic acid sutures, polyglactin 910, catgut, and polydioxanone or a biocompatible metal including stainless steel or Nitinol wire.

16. The device of claim 14 or claim 15, wherein the attachment means comprises first and a second apertures and wherein one end of the cutting thread or suture is threadable through the first aperture and the second end is threadable through the second aperture.

17. The device of any one of the preceding claims, wherein the elongate body extends along the main axis and the locator member comprises a locator tip extending from the second end of the elongate body along a second axis which is different to the main axis.

18. The device of claim 17, wherein the second axis is at an angle relative to the main axis, said angle being between 20° and 70°.

19. The device of claim 18, wherein the angle is between 20° and 40°.

20. The device of any one of claims 3 to 16, wherein the locator member is spaced from the second end of the elongate body and extends outwardly from the upper surface of the elongate body.

21. The device of claim 20, wherein the locator member comprises a protrusion extending along an axis which is substantially perpendicular to the main axis of the elongate body.

22. The device of claim 20, wherein the locator member comprises a protrusion extending along an axis which is at an angle of between 20° and 70° relative to the main axis of the elongate body.

23. The device of claim 20, wherein the locator member comprises a protrusion extending along an axis which is at an angle of approximately 30°.

24. A method of separating a tendon including:

25. The method of claim 24, wherein the separating member comprises a cutting thread or suture extending from one end to a second end.

26. The method of claim 25, comprising threading the one end of the cutting thread or suture through the opening incised in the tendon and feeding the thread or suture through the opening and around an edge of the tendon.

27. The method of claim 26, wherein the attachment means comprises two apertures formed in the elongate body, said apertures extending from an opening in an upper surface of the elongate body to an opening in the lower surface of the elongate body and the method comprises threading the one end of the thread or suture through one aperture and the second end of the thread or suture through the second aperture.

28. A device for use in separating a tendon comprising:

said elongate body further including a tendon separating member ; wherein the elongate body and the locator member are configured to pass through a tendon sheath of a patient from a first incision to a second incision and to be removed from a patient through said second incision such that the tendon separating member separates at least part of the tendon as the elongate body is moved through the tendon sheath.

29. The device of claim 28, wherein the separating member comprises a hook extension from the first end of the elongate body, said hook extension including a cutting surface.

30. The device of claim 29, wherein the hook extension is formed from a biocompatible material selected from any one of medical grade stainless steel or a polymeric material with a suitably sharp cutting surface.

32. The device of claim 31, further comprising a locator member, said locator member positioned at or spaced from the second end of the elongate body.

33. The device of claim 32, wherein the elongate body extends along the main axis and the locator member comprises a locator tip extending from the second end of the elongate body along a second axis which is different to the main axis.

34. The device of claim 33, wherein the second axis is at an angle relative to the main axis, said angle being between 20° and 70°.

35. The device of claim 32, wherein the locator member is spaced from the second end of the elongate body and extends outwardly from the upper surface of the elongate body.

36. The device of claim 35, wherein the locator member comprises a protrusion extending along an axis which is substantially perpendicular to the main axis of the elongate body.

37. The device of claim 35, wherein the locator member comprises a protrusion extending along an axis which is between 20° and 70 degrees relative to the main axis.

38. The device of any one of claims 31 to 37, wherein the attachment means comprises one or more apertures extending from an opening formed in an upper surface of the elongate body and to an opening formed in an opposed lower surface of the elongate body.

39. The device of claim 38, wherein the tendon or part of the tendon is attached to the device by sutures through the one or more apertures.