The present invention relates generally to suture anchors, and more particularly suture anchors that are capable of being used in both a knotted and knotless configuration.
Suture anchors are used to attach tendons, ligaments, soft tissue and implants such as synthetic grafts, to bone. The surgeon proceeds by fashioning a tunnel in the bone and inserting an anchor into the tunnel which will secure a suture to the bone. The suture anchor can have external threads in the manner of a screw such that when rotated the suture anchor will advance securely into the tunnel and resist removal.
The suture anchor is mounted to an anchor insertion device having a handle and a drive shaft with structure for engaging and retaining the suture anchor. The suture anchor has a socket for engaging a mating head portion of the drive shaft so as to secure the suture anchor to the drive shaft and allow for the rotation of the suture anchor by manipulation of the insertion device so as to thread the suture anchor into the tunnel. The insertion device is used to position the suture anchor at the tunnel formed in the bone, and then the drive shaft is rotated so as to thread the suture anchor into the bone tunnel. Any knotless sutures required for the repair are passed thought the distal eyelet in the anchor tip and are then passed through the tissue prior to anchor insertion. The sutures are tensioned to approximate the tissue to the bone and become locked in place between the threads of the anchor and the bone tunnel after the anchor is inserted. Any sliding sutures are passed through the tissue after insertion, tensioned and knots are tied to secure the tissue in place. The drive shaft is removed from the socket of the suture anchor, the repair is completed, and the incision is closed.
The strength and integrity of the suture anchor is of paramount importance to ensure an efficient and long-lasting repair. In the past, such suture anchors were made from implantable metals or alloys which had high strength and durability, but were difficult and costly to fashion. More recently, polymer, ceramic, or composite materials have been developed. These include biodegradable and nonbiodegradable materials. Such materials are less expensive and easier to manufacture than their metal counterparts.
The suture anchor must be able to withstand the forces and particularly the torque that is necessary to properly insert the suture anchor into the tunnel. Failure of the suture anchor in this regard can result in stripping of the socket or even shearing of a portion of the suture anchor. There is a need for suture anchors that are easily manufactured, are capable of withstanding necessary torque forces during insertion, and will also provide a durable and long-lasting repair.
A suture anchoring system includes an anchor insertion device comprising a handle and a drive shaft with a long axis. The suture anchor has an elongated anchor body having proximal and distal ends and a long axis, with an elongated axial drive opening extending along the long axis. The axial drive opening defines an inside surface of the anchor body. The anchor body has an outside surface radially outward from the inside surface. A plurality of axial drive grooves have a long axis parallel to the long axis of the elongated anchor body. The drive grooves have a radially inward and axially extending groove opening communicating with the axial drive opening, and a contact surface radially outward from the groove opening. The radially outward contact surface has a greater width than the groove opening. The axial drive grooves further include side surfaces extending between the contact surface and the axially extending opening of the axial drive grooves. The side surfaces can be oriented at an acute angle to the radially outward contact surface. Threads are provided on the outside surface of the anchor body for engaging the bone. The drive shaft of the anchor insertion device comprises radially outwardly extending axial drive projections configured to mate with the axial drive grooves.
The axial drive grooves can be circumferentially spaced apart and equidistant from adjacent axial drive grooves. The axial drive projections can be similarly circumferentially spaced apart and equidistant from adjacent axial drive projections, such that the drive shaft and the axial drive projections can be axially inserted into the elongated axial drive opening and the axial drive grooves.
The threads are provided as a double helix or other multi-start thread configuration. The threads can be buttress style threads or have a thread profile which has a sloping leading edge angle to easily displace the bone during insertion and a trailing edge angle that is less sloping to better resist the tensile forces of the sutures pulling on the anchor and prevent loss of fixation in the bone
The axial drive grooves in a lateral cross section orthogonal to the long axis of the anchor body can be isosceles trapezoidal in shape. The axial drive projections of the drive shaft of the anchor insertion device can, in a lateral cross section orthogonal to the long axis of the drive shaft, also be isosceles trapezoidal in shape so as to mate with and engage the axial drive grooves. The contact surface can be at least one selected from the group consisting of planar and curved. The contact surface can be concave.
The axial drive opening and the axial drive grooves can extend from the proximal end to the distal end of the elongated anchor body. Friction projections can be provided on the inside surface of the axial drive opening to assist in retaining the suture anchor in position prior to deployment.
The anchor body can further comprise of a plurality of flow passages for permitting ingress of biological material from a patient into the axial drive opening. The anchor body can include elongated radially inwardly extending braces between the axial drive grooves. The plurality of flow passages can be positioned so as to pass through the braces.
The anchor body can comprise biocompatible plastic, the biocompatible plastics comprising at least one selected from the group of biocomposite and nonbiocomposite materials. One such biocomposite material is poly(L-lactide-co-glycolide) and β-TCP in a 70:30 ratio, and one such nonbiocomposite plastic material is polyether ether ketone (PEEK).
The suture anchor can include a suture retention tip comprising at least one eyelet for receiving a suture. The suture retention tip further can have an open interior and a retention post in the open interior for engaging a retention suture. The suture retention tip can be detachable from the anchor body.
A suture anchor includes an elongated anchor body having proximal and distal ends and a long axis, with an elongated axial drive opening extending along the long axis. The axial drive opening defines an inside surface of the anchor body. The anchor body has an outside surface radially outward from the inside surface. A plurality of axial drive grooves has a long axis parallel to the long axis of the elongated anchor body. The drive grooves have a radially inward and axially extending groove opening communicating with the axial drive opening, and a contact surface radially outward from the groove opening. The radially outward contact surface has a greater width than the groove opening. The axial drive grooves further comprise side surfaces extending between the contact surface and the axially extending opening of the axial drive grooves. The side surfaces are oriented at an acute angle to the radially outward contact surface. Threads are provided on the outside surface of the anchor body.
The axial drive grooves can be circumferentially spaced apart and equidistant from adjacent axial drive grooves. The axial drive grooves, in a lateral cross section orthogonal to the long axis, can be isosceles trapezoidal in shape.
The threads can be provided as a double helix. The threads can be buttress threads.
A suture anchor having a suture anchor body having an external surface, can have a double helix thread on the external surface. The double helix thread can be a buttress thread. The suture anchor can be made from a plastic material. The suture anchor can comprise an open interior, and plurality of flow passages in the suture anchor body communicating with the open interior.
There are shown in the drawings embodiments that are presently preferred it being understood that the invention is not limited to the arrangements and instrumentalities shown, wherein:
A suture anchoring system includes a suture anchor and an anchor insertion device comprising a handle and a drive shaft with a long axis. The suture anchor has an elongated anchor body having proximal and distal ends and a long axis, with an elongated axial drive opening extending along the long axis. The axial drive opening defines an inside surface of the anchor body, and the anchor body has an outside surface radially outward from the inside surface. A plurality of axial drive grooves has a long axis parallel to the long axis of the elongated anchor body. The drive grooves have a radially inward and axially extending groove opening communicating with the axial drive opening, and a contact surface radially outward from the groove opening. The radially outward contact surface has a greater width than that of the groove opening. The axial drive grooves further include side surfaces extending between the contact surface and the axially extending opening of the axial drive grooves. The side surfaces are oriented at an acute angle to the radially outward contact surface and can have the same dimension. Threads are provided on the outside surface of the anchor body. The drive shaft of the anchor insertion device has radially outwardly extending axial drive projections configured to mate with the axial drive grooves.
The axial drive grooves can be circumferentially spaced apart and equidistant from adjacent axial drive grooves. The axial drive projections on the drive shaft are similarly circumferentially spaced apart and equidistant from adjacent axial drive projections, such that the drive shaft and the axial drive projections can be axially inserted into the elongated axial drive opening and the axial drive grooves. Four such drive groves can be provided and circumferentially spaced apart, however more or fewer of such drive grooves are possible.
The threads of the suture anchor can have differing thread characteristics such as dimensions, thread shape and pitch. The threads can be provided as a double helix or in another multi-start thread configuration. Double helix threads advance the suture anchor further with each rotation, such that fewer rotations will be necessary to advance the suture anchor into position. The threads can be buttress threads. Buttress threads present an asymmetric thread profile, with the distal face being slanted and the proximal face perpendicular to the long axis, or less slanted than the distal face. The more perpendicular proximal face will resist pull out upon the application of an axial load. A suture anchor with such double helix or other multi-start helical threads can have differing configurations, and can be made with a drive opening that extends axially through the anchor body, or only partially extends into the anchor body in the form of a socket for the drive head of a drive shaft.
The precise shape of the axial drive grooves can vary. For example, in a lateral cross section orthogonal to the long axis of the anchor body, the axial drive grooves can be isosceles trapezoidal in shape, and in a lateral cross section orthogonal to the long axis of the drive shaft, the axial drive projections can be isosceles trapezoidal in shape. As used herein the term isosceles trapezoidal is intended to include sides that may be slightly nonplanar so long as imaginary lines connecting the endpoints of the sides result in a configuration of an isosceles trapezoid. For example, the contact surface can be either planar or curved. The contact surface can be concave and the drive projections on the drive shaft can have a matching convex surface.
The axial drive opening and the drive grooves form a socket to engage the projections of the anchor insertion device. The axial drive grooves can extend from the proximal end to the distal end of the elongated anchor body. In this manner, the suture anchor can slide onto the projections of the drive shaft of the anchor insertion device and will be retained on the drive shaft until it is discharged by operation of the anchor insertion device. The suture anchor can further include friction projections on the inside surface of the axial drive opening to help to retain the anchor until it is ready to be released from the anchor insertion device. It is also possible that the drive opening and the drive grooves extend only partially from the proximal end of the anchor body, forming a socket for the drive shaft and projections at the distal end of the anchor insertion device.
The anchor body can have a plurality of flow passages. The flow passages can allow for egress of certain materials, such as Tactoset® (Anika Therapeutics, Inc., Bedford, MA) bone void substitute that can be injected through the anchor to encourage bone ingrowth and augment the fixation of the suture anchor. The anchor body can have elongated radially inwardly extending braces between the axial drive grooves. The flow passages can pass through the braces such that the anchor body will be reinforced at the location where the flow passages are present.
The suture anchor can be made from a variety of different materials. The anchor body can comprise biocompatible plastic. The biocompatible plastics can include at least one selected from the group of biocomposite and non-biocomposite plastics. One such biocomposite material is poly(L-lactide-co-glycolide) and β-TCP in a 70:30 ratio, and one such non-biocomposite material is polyether ether ketone (PEEK). Other materials are possible.
The suture anchor can further include a suture anchor tip that has a pointed end for displacing biological material as it is inserted into position. The suture anchor tip can be detachable from the anchor body. The suture anchor tip can have structure such as a lateral eyelet or axial opening for passing a suture through the suture anchor tip. The suture anchor tip can have an open interior and a retention post in the open interior for engaging the suture. The suture can be part of the repair, or can be a retention suture that is used to retain the detachable suture anchor tip until it is ready to be deployed.
A method for securing a suture includes the step of providing the suture anchor system including a suture anchor as described and an anchor insertion device with a drive shaft for engaging the suture anchor. The suture anchor can be pre-loaded onto the drive shaft and the assembly packaged in a sterile packaging for ready use. The method includes the step of engaging the drive shaft to the suture anchor with the axial drive projections positioned in and engaging the axial drive grooves. The suture anchor engaged to the drive shaft is positioned in a target location. The drive shaft is rotated and the suture anchor will also rotate. A force is applied by the anchor insertion device while advancing the suture anchor such that the threads engage the bone or tissue surrounding the target location. The suture anchor system can further include a suture anchor tip, and the method can include the step of positioning the suture anchor tip on the shaft and securing it with a tip retention suture. The threads on the suture anchor can be provided as a double helix, and the double helix will advance the suture anchor more rapidly with turns of the handle.
There is shown in
The anchor body 21 has an interior drive opening 27 with a long axis 15 which forms a socket for receiving the distal end drive head of a drive shaft for purposes of rotating the anchor 20 such that the helical threads 25 and 26 of the anchor 20 will engage the bone tunnel and advance the suture anchor 20 into the bone tunnel. A plurality of axial drive grooves 28 have a long axis 17 parallel to the long axis 15 of the elongated anchor body (
The suture anchor 20 can also include a plurality of flow passages 29 which are openings in the anchor body 21 communicating between the exterior and the interior opening 27. The flow passages 29 are positioned between the helical threads 25 and 26 and after implantation permit the ingress of bodily fluid and tissue into the interior drive opening 27 so as to integrate the suture anchor 20 with surrounding soft tissue and bone. Braces 59 can be provided between the axial drive grooves 28 and are thicker wall portions of the anchor body 21 than the wall portions radially outward from the drive grooves 28, as shown particularly in
The helical threads 25 and 26 can take differing forms, including dimensions, thread shape and pitch. There is shown in
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The operation of the suture anchoring system is shown in
The handle 33 is then rotated in the manner shown by arrow 140 in
In some procedures it will be desirable that the retention suture 78 is used for the repair. This is shown in
The invention as shown in the drawings and described in detail herein disclose arrangements of elements of particular construction and configuration for illustrating preferred embodiments of structure and method of operation of the present invention. It is to be understood however, that elements of different construction and configuration and other arrangements thereof, other than those illustrated and described may be employed in accordance with the spirit of the invention, and such changes, alternations and modifications as would occur to those skilled in the art are considered to be within the scope of this invention as broadly defined in the appended claims. In addition, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.