Patent Description:
Tearing of, or the complete or partial detachment of ligaments, tendons and/or other soft tissues from their associated bones within the body are commonplace injuries, particularly among athletes. Such injuries generally result from excessive stresses being placed on these tissues. By way of example, tissue tearing or detachment may occur as the result of an accident such as a fall, over-exertion during a work-related activity, or during the course of an athletic event. In the case of tearing or a partial or complete detachment of soft tissue from a bone, surgery is typically required to reattach the soft tissue (or a graft tissue) to the bone.

Numerous devices have been used to secure soft tissue to bone. Examples of such devices include screws, tacks, staples, suture anchors, and suture alone. In soft tissue repair or re-attachment procedures utilizing suture anchors, an anchor-receiving hole is drilled into bone at the desired point of fixation or tissue re-attachment, and a suture anchor is deployed into the hole using an appropriate installation tool. A suture, coupled to the anchor and passed through or around the soft tissue, thus becomes effectively locked to the bone, which secures the soft tissue to the bone.

During a suture anchoring procedure, it can be challenging to deploy the suture anchor into the anchor-receiving hole. Further, existing suture anchors and inserter devices used to insert the anchors into bone may have certain disadvantages that complicate their use and/or impose certain undesirable limits. Also, procedures that require the suture to be tied into a knot can be time-consuming and cumbersome due to inherent space constraints, which can complicate a surgery. <CIT> discloses an apparatus for securing a first object to a second object, the apparatus comprises: an elongated body having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end, the lumen comprising a distal section and a proximal section, the distal section of the lumen having a wider diameter than the proximal section of the lumen; a window extending through the side wall of the elongated body and communicating with the lumen, the window being disposed in the vicinity of the intersection between the distal section of the lumen and the proximal section of the lumen and being sized to receive a first object therein; an elongated element extending through the lumen of the elongated body, the elongated element comprising a proximal end and a distal end; and a locking element mounted to the distal end of the elongated element and disposed in the distal section of the lumen; whereby, when the elongated body is disposed in a second object, and the first object extends through the window, and the locking element is thereafter moved proximally, proximal movement of the locking element causes the locking element to capture the first object to the elongated body, whereby to secure the first object to the second object; wherein the elongated element comprises a pull line terminating in a loop; and wherein the locking element comprises at least one filament extending through the loop. <CIT> discloses a suture anchor which includes an outer sleeve having a longitudinal throughbore and defining leading and trailing ends and an insert positionable within the longitudinal throughbore of the outer sleeve. The insert defines at least one suture track for slidably supporting a suture whereby opposed free ends of the suture extend from the at least one suture track through the longitudinal throughbore to extend beyond the trailing end of the outer sleeve to be tensioned and secured relative to the tissue. The outer sleeve may include an external thread for threaded rotation and advancement into the tissue. <CIT> discloses a placement system and method for a tissue graft anchor by which a surgeon may introduce one or more sutures into a hole in a boney tissue, apply tension to the sutures to advance a soft tissue graft to a desired location, and then advance the anchor into the bone while maintaining suture tension and without introducing spin to the suture. <CIT> discloses a driver (<NUM>) for mounting a suture anchor (<NUM>) with a connected suture (<NUM>). The driver includes a cylindrical solid body (<NUM>), and has an anchor mount (<NUM>) formed as its distal end that is for receiving a coupling end of the anchor (<NUM>). A first curved passage (<NUM>) is formed in the driver body distal end and intersects a center longitudinal passage (<NUM>) through the anchor mount, and extends to the driver body surface where it intersects a straight longitudinal groove (<NUM>). The groove intersects, on its proximal end, an inlet end (<NUM>) of a second curved passage (<NUM>) that exits the driver body surface on the opposite side to the longitudinal groove. <CIT> discloses a bone anchor system including an anchor driver having an outer shaft a middle shaft, and an inner shaft; an anchor body slidably coupled to the outer shaft; a tip configured to releasably mate with a distal end of the middle shaft; and an eyelet including a proximal end configured to releasably mate with an interference coupling element of the inner shaft, and a distal end configured to mechanically couple with the tip. <CIT> discloses a soft tissue repair system comprising: at least one anchor, the at least one anchor comprising a body, a bone-engaging element attached to the body for securing the body in bone, and a suture- attaching element attached to the body for attaching suture to the anchor, the suture-attaching element being configured so as to permit suture to be snared by the suture-attaching element after the anchor has been deployed in the bone.

Accordingly, there is a need for improved methods and systems for attaching tissue to bone.

The present invention provides a surgical system comprising a driver device having a distal driver member; an elongate shaft having a central shaft portion and a distal shaft portion, a capture suture, and an implantable dilator. The central shaft portion has a suture retaining feature extending therethrough proximal to a distal shoulder of the central shaft portion, the suture retaining feature communicating with an opening extending through a side of the central shaft portion proximal to the distal shoulder of the central shaft portion. The distal shaft portion extends from the distal shoulder of the central shaft portion to a distal end of the elongate shaft. The capture suture extends through the suture retaining feature of the central shaft portion and the opening such that terminal end portions of the capture suture extend from a proximal end of the driver device and the capture suture forms a loop that extends through the opening. The suture anchor is removably disposed on a distal driver member of a driver device having the elongate shaft extending therethrough. The implantable dilator feature is removably disposed on the distal shaft portion distal to the suture anchor such that the distal end of the elongate shaft extends distally from a distal end of the dilator feature.

In one aspect, a surgical system is provided according to the claims that in some embodiments includes a driver device, an elongate shaft having a central shaft portion and a distal shaft portion, a capture suture, a suture anchor, and a dilator feature disposed distal to the suture anchor. The driver device has a proximal handle and a driver shaft extending therefrom, the driver shaft having a distal driver member and a lumen extending therethrough. The elongate shaft has a central shaft portion and a distal shaft portion, the elongate shaft being receivable within the lumen of the driver device such that a distal end and at least part of the central shaft portion extend distally from the distal driver member, the central shaft portion having a suture retaining feature that extends therethrough from the distal end of the central shaft portion and that communicates with an opening extending through a side of the central shaft portion. The capture suture extends through the suture retaining feature and the opening such that terminal end portions of the capture suture extend from the driver device and the capture suture forms a loop that extends through the opening. The suture anchor has external threads formed thereon, the suture anchor being removably mountable on the distal driver member. The dilator feature is disposed distal to the suture anchor and has the distal shaft portion at least partially extending therethrough such that a distal end of the elongate shaft extends distally from the dilator feature.

The surgical system can vary in many different ways. For example, the loop of the capture suture can be configured to receive at least one retention suture therethrough, the loop having the retention suture received therethrough being configured to be tightened by pulling the terminal end portions of the capture suture, thereby coupling the retention suture with the suture anchor. In the present invention, the terminal end portions of the capture suture extend from a proximal end of the driver device.

In at least some embodiments, the suture retaining feature can be a groove. In at least some embodiments, the distal driver member can be a male feature configured to be received within a corresponding female feature of the suture anchor. In at least some embodiments, the central shaft portion of the elongate shaft has an outer diameter that is greater than an outer diameter of the distal shaft portion of the elongate shaft.

In at least some embodiments, the dilator feature can be made from a non-metallic material. In at least some embodiments, the system further includes a proximal end feature configured to be disposed at a proximal end of the central shaft portion and having at least one retaining feature configured to engage the terminal end portions of the capture suture. The at least one retaining feature can be configured to engage the terminal end portions of the capture suture to tension the capture suture.

The system of the present invention can be used in a method of performing a surgical repair, which is not part of the invention, including inserting a distal end of an elongate shaft into a bone, the shaft extending through an implantable dilator feature and a distal driver member of a driver device having a suture anchor releasably coupled thereto that is positioned proximal to the dilator feature, and the elongate shaft having a capture suture extending through a suture retaining feature formed through the elongate shaft and exiting at an opening extending through a side of the elongate shaft such that the capture suture forms a loop that extends through the opening. The method further includes passing a retaining suture coupled to tissue through the loop, closing the loop having the retaining suture passed therethrough by applying tension to the terminal end portions of the capture suture such that the loop retains the retaining suture against a sidewall of the elongate shaft, and driving the suture anchor distally towards the dilator feature and into the bone and thereby secure the retaining suture between the bone and an outer surface of the suture anchor.

The method can vary in many different ways. For example, the capture suture can form the loop such that terminal end portions of the capture suture are adjacent a proximal end of the elongate shaft. As another example, the method can further include closing of the loop prior to inserting the distal end of the elongate shaft into the bone. As another example, the method can further include tensioning the terminal end portions of the capture suture while the distal end of the elongate shaft is inserted into the bone. As yet another example, the method can further include removing the capture suture after the suture anchor has been driven into the bone. In at least some embodiments, the method further includes driving the suture anchor distally towards the dilator feature and into the bone using a driver device removably coupled to the suture anchor.

The surgical system can vary in many different ways. For example, the dilator feature can have a shape of a truncated cone. As another example, the central shaft portion of the elongate shaft can have an outer diameter that is greater than an outer diameter of the distal shaft portion of the elongate shaft.

The present disclosure will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:.

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.

Various devices are provided for securing tissue to bone as described in the claims. In general, the devices can facilitate securing suture to tissue. In the present invention, a surgical system for attaching tissue to bone includes a driver device, an elongate shaft having a central shaft portion and a distal shaft portion, a capture suture, and a suture anchor as described in the claims. The surgical system also includes a dilator feature, which is implantable. The suture anchor and the dilator feature can be cannulated.

The driver device may have a proximal handle and a driver shaft extending from the handle. The driver shaft can have a shoulder proximal to a distal driver member, and a lumen extending through the driver shaft. The elongate shaft is receivable within the driver device such that a distal end and at least part of the central shaft portion extend distally from the distal driver member.

The central shaft portion of the elongate shaft has a suture retaining feature that extends therethrough from the distal end of the central shaft portion and that communicates with an opening extending through a side of the central shaft portion. In some embodiments, the suture retaining feature extends to a termination point within the central shaft portion that is proximal to a distal shoulder of the central shaft portion. The suture retaining feature can be, for example, a groove, channel, lumen, or other suitable feature. The distal shaft portion of the elongate shaft extending from the distal shoulder of the central shaft portion can have an outer diameter that is less that an outer diameter of the central shaft portion of the elongate shaft. The distal end of the distal shaft portion is configured to initiate a hole in bone.

The capture suture extends through the suture retaining feature of the central shaft portion of the elongate shaft and the opening of the elongate shaft such that terminal end portions of the capture suture extend from a more proximal position along the driver device. For example, in some embodiments, the terminal end portions of the capture suture extends from a proximal end of the driver device. The capture suture forms a loop that extends through the opening of the central shaft portion of the elongate shaft. The loop formed by the capture suture is configured to receive at least one retention suture therethrough, and the capture suture loop is configured to be tightened or closed by pulling the terminal end portions of the capture suture. The size of the capture suture loop can be such that the capture suture loop can receive therethrough multiple retention sutures, which can improve the strength of attachment of tissue to bone.

The suture anchor, which can have one or more external threads formed thereon, is removably mountable on the distal driver member of the driver device.

The system of the present invention can be used in a method for performing a surgical repair to attach or reattach soft tissue to bone, said method is not included in the invention. This method includes creating a hole in bone by inserting a distal end of an elongate shaft into a bone. The elongate shaft can extend through an implantable dilator feature configured to dilate the hole, and through a suture anchor loaded on the driver device proximal to the dilator feature. The elongate shaft has a capture suture extending through a suture retaining feature formed therethrough and exiting at an opening extending through a side of the elongate shaft and disposed proximal to the dilator feature. The capture suture forms a loop that extends through the opening of the elongate shaft, and the terminal end portions of the capture suture extend proximally, for example, the terminal end portions can extend from the proximal end of the driver device. The method also includes passing a retaining suture coupled to tissue through the loop, closing the loop by applying tension to the terminal ends of the capture suture such that the loop retains the retaining suture against a sidewall of the elongate shaft, and driving the suture anchor distally towards the distal feature and into the bone and thereby secure the retaining suture between the bone and an outer surface of the suture anchor.

<FIG> illustrate one embodiment of a surgical system <NUM> that includes an elongate shaft <NUM>, a driver or driver device <NUM> that receives the elongate shaft <NUM> therethrough, a capture suture <NUM> forming a loop <NUM> as discussed below, and a suture anchor <NUM>. The system <NUM> also includes a dilator feature <NUM>, which is implantable.

The components of the system <NUM> can have various configurations. As shown in <FIG>, the driver device <NUM> that is configured to drive the suture anchor <NUM> into bone has a proximal handle <NUM> and a driver shaft <NUM> extending therefrom. The driver shaft <NUM> can be coupled to the handle <NUM> in various ways, and it can extend through the handle <NUM>. As shown in <FIG>, the driver shaft <NUM> has a shoulder <NUM> proximal to a distal driver member <NUM>, and a lumen <NUM> extending therethrough. The driver shaft <NUM> can have dimensions that are appropriate for a given surgical procedure. For example, the driver shaft can have a diameter in the range of about <NUM> to about <NUM> and a length in the range of about <NUM> to about <NUM>. The driver member <NUM> likewise can have dimensions that are appropriate for a given surgical procedure. For example, the distal driver member <NUM> can have a diameter in the range of about <NUM> to about <NUM>, and a length in the range of about <NUM> to about <NUM>.

The proximal handle <NUM> of the driver device <NUM> can have a variety of configurations. In the illustrated embodiments, the lumen <NUM> extends through the driver shaft <NUM> of the driver device <NUM> as well as through the length of the proximal handle <NUM>. In other embodiments, the driver shaft <NUM> can be coupled to the proximal handle <NUM> in a suitable manner, and a lumen extending through the proximal handle <NUM> can communicate with a lumen extending through the driver shaft <NUM>.

The proximal handle <NUM> of the driver device <NUM> can be configured to have surface features that facilitate grip during use of the driver device <NUM>. For example, as shown in <FIG> and <FIG>, the proximal handle <NUM> can have grooves <NUM> formed along its length. It should be appreciated, however, that the proximal handle <NUM> can have any suitable features, as the described embodiments are not limited in this respect. The dimensions and configuration of the handle <NUM> can be such that they allow for a convenient grip and efficacy during a surgical procedure.

The suture anchor <NUM> can have various configurations. In the illustrated embodiments, the suture anchor <NUM> has external threads <NUM> formed thereon configured to engage the suture anchor <NUM> with the bone. The suture anchor <NUM> can have any suitable configuration and can have other bone-engaging features. The suture anchor <NUM> can have a lumen <NUM> extending therethrough such that at least in a portion of the lumen <NUM> can receive therein the distal driver member <NUM> of the driver shaft <NUM> of the driver device <NUM>. The lumen <NUM> of the driver shaft <NUM> receives the elongate shaft <NUM> therethrough. In an assembled configuration, as shown in <FIG>, the distal driver member <NUM> extends through the suture anchor <NUM> such that a distal end 120d of the distal driver member <NUM> (which is also a distal end of the driver shaft <NUM>) is disposed proximal to a distal end 110d of the suture anchor <NUM>. However, in other embodiments, the distal end 120d of the distal driver member <NUM> can be aligned with or can extend beyond the distal end <NUM>10d of the suture anchor <NUM>. In the assembled configuration, as illustrated in <FIG> and <FIG>, the suture anchor <NUM> is mounted on the driver shaft <NUM> of the driver device <NUM> such that the suture anchor <NUM> is proximal to and spaced apart from the dilator feature <NUM>.

The dimensions of the suture anchor <NUM> can vary depending on the requirements of a given surgical procedure. For example, the suture anchor can have a diameter in the range of from about <NUM> to about <NUM>, and a length in the range of from about <NUM> to about <NUM>. The suture anchor <NUM> can be made from any suitable materials. For example, it can be made from a polymer, examples of which include polyether ether ketone (PEEK), polylactic pcid (PLA), poly(L-lactic acid) (PLLA), etc. Additionally, the polymer can be radiolucent and / or bioabsorbable or biodegradable.

The distal driver member <NUM> is configured to releasably mate with the suture anchor <NUM> and to drive the suture anchor <NUM> mated thereto distally into bone, as discussed in more detail below. In some embodiments, as illustrated herein, the distal driver member <NUM> can be in the form of a male feature configured to be received within a corresponding female drive feature of the suture anchor <NUM>. In the illustrated embodiment, as shown in <FIG>, the male feature is hexagonal-shaped, and the corresponding female drive feature of the suture anchor <NUM> can be a corresponding hexagonal-shaped female drive feature formed in at least a portion of the lumen <NUM> of the suture anchor <NUM>.

In the illustrated embodiment, as shown in <FIG>, the elongate shaft <NUM> has a central shaft portion <NUM> and a distal shaft portion <NUM> extending distally from a distal shoulder <NUM> of the central shaft portion <NUM> and terminating at the distal end <NUM> of the elongate shaft <NUM>. It should be appreciated that in other embodiments, the distal shoulder <NUM> may not be formed. As also shown in <FIG>, the distal shaft portion <NUM> can include a distal awl tip portion <NUM>, which is, in this example, distally tapered.

The dimensions of the central shaft portion <NUM> and the distal shaft portion <NUM> can vary depending on the requirements of a given surgical procedure. In the illustrated embodiment, the central shaft portion <NUM> of the elongate shaft <NUM> can have an outer diameter that is greater than an outer diameter of the distal shaft portion <NUM> of the elongate shaft <NUM>. For example, in at least some embodiments, the central shaft portion <NUM> can have a length in a range of from about <NUM> to about <NUM>, and an outer diameter in a range from about <NUM> to about <NUM>. For another example, in at least some embodiments, the distal shaft portion <NUM> can have a length in a range of from about <NUM> to about <NUM>, and an outer diameter in a range from about <NUM> to about <NUM>.

The elongate shaft <NUM> can be received within the driver device <NUM> such that a distal shaft portion <NUM> terminating with the distal end 102d, and at least a part of the central shaft portion <NUM> of the elongate shaft <NUM> extend distally from the distal driver member <NUM>. In the illustrated embodiments, the elongate shaft <NUM> is configured to be inserted into bone to initiate a hole. Thus, there is no need to initiate a hole in the bone using other instruments.

In the illustrated embodiment, the central shaft portion <NUM> of the elongate shaft <NUM> has a suture retaining feature <NUM> extending therethrough that is configured to seat the capture suture. As shown in <FIG>, the suture retaining feature <NUM> can extend from the opening <NUM> extending through a side of the central shaft portion <NUM> of the elongate shaft <NUM>. The suture retaining feature <NUM> can extend to a termination point within the central shaft portion <NUM> that is proximal to the opening <NUM> formed in the central shaft portion <NUM>.

The suture retaining feature <NUM> can have any suitable configuration and can be formed in any suitable manner in the elongate shaft <NUM> so as to seat the capture suture <NUM>. In the illustrated embodiment, as shown in <FIG>, the suture retaining feature <NUM> can be in the form of a groove formed along or parallel to a longitudinal axis L of the elongate shaft <NUM>. The groove can be formed in the outer surface of the central shaft portion <NUM>. However, in other embodiments, the suture retaining feature <NUM> can be in the form of a lumen or other feature.

In the illustrated embodiment, the surgical system <NUM> includes the dilator feature <NUM> that is distal to the suture anchor <NUM>. The distal shaft portion <NUM> of the elongate shaft <NUM> is configured to extend through the dilator feature <NUM> (shown separately in <FIG>) such that the distal end 102d of the elongate shaft <NUM> extends distally from a distal end 112d of the dilator feature <NUM>. The dilator feature <NUM> is configured to facilitate insertion of the elongate shaft <NUM> into bone by enlarging the dimensions of a hole in bone initially formed by the distal end 102d of the elongate shaft <NUM>. In this example, the dilator feature <NUM> is distally tapered and is in the form of a truncated cone, though it can have other configurations. The dilator feature <NUM> can be press-fit onto or otherwise coupled with the elongate shaft <NUM> (e.g., via a threaded connection or via other suitable mating feature(s)). The dilator feature <NUM> may lack surface features, as in the illustrated example. However, in some embodiments, the dilator feature <NUM> can have one or more surface features that facilitate its engagement with the bone. The dilator feature <NUM> can have any suitable dimensions. For example, in at least some embodiments, the dilator feature <NUM> can have an outer diameter of about or less than <NUM> and a length of about or less than <NUM>.

In some embodiments, the dilator feature <NUM> can be implantable and it can be made from a non-metallic material. This can be beneficial since the properties of the dilator feature <NUM> are such that they do not interfere with imaging of the system <NUM>. Moreover, while it is sufficiently rigid to assist in forming a bone hole, the dilator feature <NUM> can be bioabsorbable and/or biodegradable. However, in other embodiments, the dilator feature <NUM> can be made from a metal.

In the illustrated embodiments, a soft tissue (e.g., a torn ligament, a graft tissue, etc.) can be attached to associated bone using one or more retaining sutures and the suture anchor. The retaining sutures can be coupled to the central shaft portion of the elongate shaft via the capture suture coupled to the surgical system, as discussed in more detail below.

As shown in <FIG> and <FIG>, the capture suture <NUM> included in the surgical system <NUM> extends along the suture retaining feature <NUM> of the central shaft portion <NUM> of the elongate shaft <NUM> and out of the opening <NUM> such that terminal end portions 138a, 138b of the capture suture <NUM> extend to a more proximal point within the of the driver device <NUM>. The capture suture <NUM> forms the loop <NUM> that extends through the opening <NUM>. The capture suture <NUM> is seated along the suture retaining feature <NUM> of the elongate shaft <NUM> from the proximal end of the suture retaining feature <NUM> towards the opening <NUM> and back from the opening <NUM> towards the proximal end of the suture retaining feature <NUM>. The loop <NUM> is configured to receive at least one retention suture therethrough, as discussed in more detail below. The size of the loop <NUM> can vary depending on a particular surgical procedure. For example, in some embodiments, the loop <NUM> can be as sufficiently large to allow a surgeon to pass his or her hand therethrough. Also, the size of the loop <NUM> is adjustable such that the loop <NUM> is configured to be tightened or closed by pulling the terminal end portions 138a, 138b of the capture suture <NUM>, thereby bringing the retention suture against the side wall the central shaft portion <NUM> of the elongate shaft <NUM>.

The surgical system <NUM> can have other various features that assist in operation of the system <NUM> to attach soft tissue to bone. For example, the surgical system <NUM> can include a proximal end feature <NUM> attached at or near the proximal end of the central shaft portion <NUM> of elongate shaft <NUM>, e.g., by press-fit, threaded coupling, or by other type of connection. In the illustrated embodiment, the proximal end feature <NUM> is positioned proximal to the proximal handle <NUM> of the driver device <NUM>. The proximal end feature <NUM> can have at least one retaining feature, such as, for example, notches <NUM> that are configured to engage the terminal end portions 138a, 138b of the capture suture <NUM>. It should be appreciated that the retaining feature can be in any other suitable form - e.g., grooves, ridges, hooks, clamps etc. The retaining feature <NUM> is configured to engage the terminal end portions 138a, 138b of the capture suture <NUM> to tension the terminal end portions 138a, 138b, as discussed in more detail below.

In the assembled configuration of the surgical system <NUM> shown in <FIG> and <FIG>, the elongate shaft <NUM> extends through a lumen in the cannulated driver device <NUM>, in particular, through the central lumen <NUM> extending through the proximal handle <NUM> and the driver shaft <NUM>. The distal end 102d and a portion of the central shaft portion <NUM> of the elongate shaft <NUM> extend distally from the distal driver member <NUM>. The capture suture <NUM> extends through the suture retaining feature <NUM> of the central shaft portion <NUM> of the shaft <NUM>, between the proximal end of the suture retaining feature <NUM> and the opening <NUM>, such that a mid-portion of the capture suture <NUM> forms the loop <NUM> extending from the opening <NUM>. In this configuration the terminal end portions 138a, 138b extend from the proximal end of the driver device <NUM>. The suture anchor <NUM> is removably mountable on the driver member <NUM> such that the proximal end of the suture anchor <NUM> abuts the shoulder <NUM>. Also, at least a portion of the driver shaft <NUM> extends into the lumen <NUM> in the suture anchor <NUM> such that the distal driver member <NUM> is mated with at least a portion of the lumen <NUM>. In addition, the proximal end feature <NUM> is proximal to a proximal end 114p of the proximal handle <NUM>. The elongate shaft <NUM>, driver device <NUM>, the suture anchor <NUM>, and the dilator feature <NUM> are axially aligned such that longitudinal axes of these components coincide. In the assembled configuration, the system <NUM> can include the driver device <NUM>, which receives the elongate shaft <NUM>, and the suture anchor <NUM> that is pre-loaded onto the distal driver member <NUM> of driver shaft <NUM>. However, in some embodiments, the driver device <NUM> may not be part of the assembly, and various device drivers can be separately coupled to other components of the system before a surgical procedure.

The surgical system <NUM>, or a similar system in accordance with the described techniques, can be used to perform a surgical repair method involving reattachment of soft tissue to bone or attaching a graft tissue to bone. For example, the system can be used in reattaching a tendon (e.g., the supraspinatus tendon) to bone (e.g., the humeral head) in a rotator cuff repair procedure. The described techniques can also be used for other shoulder repair procedures, as well as for knee and other joint repair procedures requiring soft tissue attachment to associated bone.

The surgical repair method includes inserting a distal end of an elongate shaft into a bone. The shaft may extend through an implantable, cannulated dilator feature and a suture anchor proximal to and, at least initially, spaced apart from the dilator feature. The elongate shaft has a capture suture extending through a lumen formed therethrough and exiting at an opening extending through a side of the shaft and disposed proximal to the dilator feature such that the capture suture forms a loop that extends through the opening and terminal end portions of the capture suture extend to a more proximal position on the shaft. The distal end of the elongate shaft with the dilator feature can be inserted into the bone until it reaches a depth sufficient to fully seat the suture anchor at the completion of the procedure.

The method also includes passing at least one retaining suture coupled to tissue through the capture suture loop, and closing the capture suture loop upon the retaining suture by applying tension to the terminal end portions of the capture suture such that the capture suture causes the retaining suture to be brought closer to a sidewall of the shaft. In this way, the retaining suture is held against the elongate shaft in a manner that allows the suture anchor to subsequently engage the retaining suture and secure it (and thus the tissue coupled thereto) to bone.

The retaining suture may be passed through the capture suture and the capture suture's loop is closed or constricted prior to inserting the distal end of the elongate shaft into the bone. The elongate shaft may be inserted into the bone while tension is applied to the capture suture to maintain the retaining suture(s) relative to the elongate shaft.

Regardless of whether the retaining suture is coupled to and engaged by the capture suture loop before or after the shaft is inserted into bone, the surgical method further involves driving the suture anchor distally towards the distal feature and into the bone and thereby secure the retaining suture between the bone and an outer surface of the suture anchor.

<FIG> illustrate a surgical repair method performed with the system of the present invention. By way of example, the surgical repair method is illustrated using the surgical system <NUM> shown in <FIG>. It should be appreciated, however, that the surgical repair method can be performed using other surgical systems, including surgical systems in which one or more components can be different from those included in the surgical system <NUM>.

<FIG> illustrates schematically bone <NUM> and soft tissue <NUM> (e.g., a tendon) that is to be reattached to the bone <NUM> using the surgical system <NUM>. The elongate shaft <NUM> of the surgical system <NUM> has the capture suture <NUM> extending therethrough such that it forms the loop <NUM> extending through the opening <NUM>. At least one retaining suture <NUM> is coupled to the tissue <NUM>, such as by being passed through or wrapped around tissue <NUM>. As shown in <FIG>, terminal end portions 206a, 206b of the retaining suture <NUM> are passed through the loop <NUM>, as schematically shown by arrows 207a, 207b. It should be appreciated that the single retaining suture <NUM> is shown by way of example only, as multiple retaining sutures can be used to couple the tissue <NUM> to the bone <NUM>. The relatively large size of the capture suture loop <NUM> and its adjustabity enable the use of multiple retaining sutures to join soft tissue to bone.

After the retaining suture <NUM> is passed through the loop <NUM>, the capture suture can be closed by applying tension to its terminal end portions 138a, 138b. As shown in <FIG>, the surgical system <NUM> includes the proximal end feature <NUM> configured to be non-removably or removably disposed at or near the proximal end of the shaft <NUM> such that the proximal end feature <NUM> is disposed proximal to the driver device's handle <NUM>. The proximal end feature <NUM> has notches <NUM> or other retaining features formed thereon (e.g., grooves) configured to engage the terminal end portions of the capture suture. Thus, as shown in <FIG>, the terminal end portions 138a, 138b are wrapped around the proximal end feature <NUM> by engaging the notches <NUM>, which facilitates maintaining tension on the terminal end portions of the capture suture <NUM> while pulling them away from the elongate shaft <NUM> (as shown schematically by an arrow <NUM>) to close the capture loop <NUM>. In this way, the retaining suture <NUM> is held against the elongate shaft <NUM> until the retaining suture <NUM> is wedged between the suture anchor <NUM> and bone, as described below. Among the advantages of the illustrated method is the ease with which the repair technique can be performed to securely reattach soft tissue to bone without the need to tie knots.

While tension is maintained on the terminal end portions 138a, 138b of the capture loop <NUM>, the distal end 102d of the elongate shaft <NUM> is inserted into the bone <NUM> to initiate a hole in the bone <NUM> at a desired location in the bone <NUM>, as shown in <FIG>. The elongate shaft <NUM> is a self-punching shaft configured to initiate the hole such that no additional instrument is required. <FIG> also illustrates that, once the bone hole is initiated, a suitable instrument <NUM>, such as mallet, hammer, or other instrument, is used to drive the elongate shaft <NUM> further distally into the bone <NUM>. In this example, the instrument <NUM> can be used to apply force to the proximal end 102p of the elongate shaft <NUM> to drive the distal end 102d of the elongate shaft <NUM> into bone <NUM> to form a hole <NUM>, as shown schematically by an arrow <NUM>. The distal end 102d of the elongate shaft <NUM> can be driven into bone <NUM> such that the distal shaft portion <NUM> of the elongate shaft <NUM> with the dilator feature <NUM> coupled thereto is inserted into the hole <NUM> in the bone <NUM>, as shown in <FIG> and <FIG>. A portion of the central shaft portion <NUM> of the elongate shaft <NUM> is also inserted into the hole <NUM>, whereas the suture anchor <NUM> is positioned at a desired position relative to the bone hole <NUM>. As shown in <FIG>, before being driven into the bone, the suture anchor <NUM> is disposed just proximal to the bone hole <NUM>. Alternatively, the suture anchor <NUM> can be disposed differently with respect to the hole <NUM> - for example, the suture anchor <NUM> can be at least partially inserted into the bone hole. The diameter of the hole <NUM> can be created such that the hole <NUM> can snugly fit the suture anchor <NUM> therein.

As shown in <FIG>, the terminal end portions 206a 206b of the retaining suture <NUM> are disposed outside the bone hole <NUM>, and tension applied thereto ensures that the suture <NUM> is positioned and temporarily held in the bone hole <NUM> in a taut state, as shown schematically by arrows 215a, 215b in <FIG>. The tension applied to the terminal end portions 206a 206b of the retaining suture <NUM> can cause the tissue <NUM> to be positioned as desired with respect to the bone hole <NUM>. For example, the tissue <NUM> can be moved closer to the bone hole <NUM>, as shown in <FIG> where the tissue <NUM> is closer to the bone hole <NUM> than the tissue <NUM> as shown in <FIG>.

Once the elongate shaft <NUM> with the dilator feature <NUM> is inserted into the bone <NUM> so as to form the bone hole <NUM> in the desired location, the suture anchor <NUM> can be driven distally towards the dilator feature <NUM> and into the bone hole <NUM> to secure the retaining suture <NUM> between the inner surface of the bone hole <NUM> and an outer surface of the suture anchor <NUM>, as shown in <FIG> and <FIG>. The driver device <NUM>, having its distal driver member <NUM> releasably coupled to the suture anchor <NUM>, is operated to drive the suture anchor <NUM> into the bone hole <NUM>. For example, the driver device <NUM> can be rotated, as schematically shown by an arrow <NUM> in <FIG>, to cause the suture anchor <NUM> coupled thereto to advance distally into bone as the threads <NUM> of the suture anchor1 <NUM> engage an interior wall of the bone hole <NUM>. As the driver device <NUM> is rotated, the elongate shaft <NUM>, which extends through the lumen <NUM> of the driver device <NUM>, remains stationary. Thus, as shown in <FIG>, after the device driver <NUM> has been driven distally, the proximal handle <NUM> of the driver device <NUM> is disposed offset from and more distal with respect to the proximal end feature <NUM> coupled to the proximal end of the elongate shaft <NUM>. The driver device <NUM> is rotated to thereby cause the suture anchor <NUM> to move distally towards the distal feature <NUM> and into the bone <NUM>, which causes the retaining suture <NUM> to be retained between the side wall of the suture anchor <NUM> and the bone hole <NUM>.

Once the suture anchor <NUM> has been driven into the hole <NUM> in the bone <NUM>, the elongate shaft <NUM> can be separated from the dilator feature <NUM>, and the driver device <NUM> can be separated from the suture anchor <NUM>, as shown schematically by an arrow <NUM> in <FIG>. In some embodiments, the elongate shaft <NUM> may not be coupled to the driver device <NUM>, and the elongate shaft <NUM> may be separated from the dilator feature <NUM> and removed from the lumen <NUM> of the driver device <NUM> before the driver device <NUM> is separated from the suture anchor <NUM>. In other embodiments, the elongate shaft <NUM> and the driver device <NUM> can be coupled to one another, and they can be separated from the dilator feature <NUM> and the suture anchor <NUM> substantially simultaneously. Regardless of the manner in which the elongate shaft <NUM> and the driver device <NUM> are removed, the dilator feature <NUM> and the suture anchor <NUM> remain implanted in the bone hole <NUM>, as shown in <FIG> and <FIG>. As shown in <FIG>, the terminal end portions 138a, 138b of the capture suture <NUM>, which are coupled to the proximal end feature <NUM> which helps tension the suture <NUM>, can be unwrapped from the proximal end feature <NUM> and thereby become separated from the proximal end feature <NUM>.

<FIG> shows the dilator feature <NUM> and the suture anchor <NUM> implanted in the bone hole <NUM>. After the elongate shaft <NUM> and the driver device <NUM> are removed, the capture suture <NUM> can remain associated with the suture anchor <NUM>, as shown in <FIG>. After the suture anchor <NUM> has been driven into the bone <NUM>, and prior to, simultaneously with, or after the elongate shaft <NUM> and the driver device <NUM> are removed, the capture suture <NUM> can be removed, as shown schematically by an arrow <NUM> in <FIG>. The terminal end portions 206a, 206b of the retaining suture <NUM> can be trimmed, e.g., by using scissors <NUM>. As a result, the suture anchor <NUM>, without the capture suture <NUM> coupled thereto, secures the retaining suture <NUM> to the bone <NUM> thereby securing the tissue <NUM> to the bone <NUM>, as shown in <FIG>. The terminal end portions 206a, 206b of the retaining suture <NUM> can be trimmed, as also shown in <FIG>.

In the surgical methods described above, the elongate shaft of the surgical system is inserted into bone after the retaining suture has been coupled to the capture suture loop and after the loop has been closed to hold the retaining suture relative to the shaft. Alternatively, as discussed above, the elongate shaft having the capture suture coupled thereto can first be inserted into the bone, and one or more retaining sutures can then be passed through the capture suture loop and the loop is tightened or closed to thereby bring the retaining suture(s) towards the elongate shaft against. Regardless of which of the above approaches are used, once the elongate shaft of the surgical system is driven into the bone to form a bone hole and the capture suture loop is closed over the retaining suture(s) passed therethrough, the suture anchor is driven distally into the bone hole. Once positioned properly in the bone hole, the suture anchor secures the retaining suture in the bone, thereby securing the tissue coupled to the retaining suture to the bone.

In some embodiments, a surgical system can include a driver device or driver, an elongate shaft, a suture anchor having external threads formed thereon, and a dilator feature distal to the suture anchor. The driver can have a proximal handle and a driver shaft extending therefrom, the driver shaft having a distal driver feature and a lumen extending therethrough, the driver having an opening extending through a side thereof. The elongate shaft is receivable in the lumen of the driver such that a distal portion of the elongate shaft extends distally from the distal driver feature, a central shaft portion of the elongate shaft having a suture retaining feature extending therethrough that communicates with the opening of the driver. The suture anchor can have a lumen extending therethrough that removably receives the central shaft portion therein, wherein the distal driver feature is operably coupled to the suture anchor. The dilator feature distal can have the distal portion of the elongate shaft at least partially extending therethrough such that at least a portion of a distal tip of the elongate shaft extends distally from a distal end of the dilator feature.

<FIG> illustrate a surgical system <NUM> which is not covered by the claims and includes an elongate shaft <NUM>, a driver <NUM> that receives the elongate shaft <NUM> therethrough, a suture anchor <NUM>, and a dilator feature <NUM> that can be implantable. The driver <NUM> can have a proximal handle <NUM>. The elongate shaft <NUM> also has a handle <NUM> coupled to a proximal end thereof. As shown in <FIG>, the handle <NUM> of the elongate shaft <NUM> is disposed proximally to the proximal handle <NUM> of the driver <NUM>. The handle <NUM> of the elongate shaft <NUM> and the proximal handle <NUM> of the driver <NUM> can be independently movable, as discussed in more detail below.

The components of the system <NUM> can have various configurations. As shown in <FIG>, the driver device <NUM> that is configured to drive the suture anchor <NUM> into bone has the proximal handle <NUM> and a driver shaft <NUM> extending therefrom. The driver shaft <NUM> can be coupled to the handle <NUM> in various ways. As shown in <FIG>, the driver shaft <NUM> has a shoulder <NUM> proximal to a distal driver member <NUM> that extends from the shoulder <NUM> to a distal end 320d of the distal driver member <NUM>, which is also a distal end of the driver shaft <NUM> of the driver device <NUM>. The distal driver member <NUM> has the suture anchor <NUM> mounted thereon, as shown in <FIG>. The driver shaft <NUM> has a neck feature <NUM> configured to seat between the shoulder <NUM> and the distal driver member <NUM> such that the neck feature <NUM> abuts a proximal end 310p of the suture anchor <NUM>. In use, the neck feature <NUM> facilitates driving the suture anchor <NUM> distally. It should be appreciated that the driver shaft <NUM> can have other suitable configurations, including the configurations in which the shoulder <NUM> and/or the neck feature <NUM> are not included.

The driver shaft <NUM> has a lumen <NUM> extending therethrough, as shown in <FIG>. The lumen <NUM> of the driver shaft <NUM> receives the elongate shaft <NUM> therethrough. Further, the driver shaft <NUM> of the driver device <NUM> has an opening <NUM> extending through a side thereof, as shown in <FIG> and <FIG>.

The proximal handle <NUM> of the driver device <NUM> can have a variety of configurations. The lumen <NUM> of the driver device <NUM> extends through the driver shaft <NUM> as well as through a length of the proximal handle <NUM>. In this way, the lumen <NUM> of the driver device <NUM> receives the elongate shaft <NUM> therethrough. The driver shaft <NUM> is coupled to the proximal handle <NUM> in a suitable manner, such that rotation of the proximal handle <NUM> causes the driver shaft <NUM> to be rotated. The proximal handle <NUM> of the driver device <NUM> can be configured to have surface features that facilitate grip during use of the driver device <NUM>. For example, as shown in <FIG>, the proximal handle <NUM> can have one or more grooves <NUM> formed along its length. It should be appreciated, however, that the proximal handle <NUM> can have any suitable features.

The suture anchor <NUM> can have various configurations. The suture anchor <NUM> has external threads <NUM> formed thereon configured to engage the suture anchor <NUM> with the bone. The threads <NUM> can be in the form of one or more threads. The suture anchor <NUM> can have any suitable configuration and can have other bone-engaging features. As shown in <FIG>, the suture anchor <NUM> can have a lumen <NUM> extending therethrough such that at least in a portion of the lumen <NUM> can receive therein the distal driver member <NUM>. In an assembled configuration, as shown in <FIG>, the distal driver member <NUM> extends through the lumen <NUM> of the suture anchor <NUM> such that the distal end 320d of the distal driver member <NUM> is disposed proximal to a distal end 310d of the suture anchor <NUM>. Alternatively, the distal end 320d of the distal driver member <NUM> can be aligned with or can extend beyond the distal end 310d of the suture anchor <NUM>.

The distal driver member <NUM> of the driver device <NUM> is configured to releasably mate with the suture anchor <NUM> and to thereby drive the suture anchor <NUM> mated thereto distally into bone, as discussed in more detail below. The distal driver member <NUM> can be in the form of a male feature configured to be received within a corresponding female drive feature formed on at least a portion of an interior wall defining the lumen of the suture anchor <NUM>.

As shown in <FIG>, the male feature is hexagonal-shaped, and the corresponding female drive feature of the suture anchor <NUM> can be a corresponding hexagonal-shaped female drive feature formed in at least a portion of an interior wall defining the lumen <NUM> of the suture anchor <NUM>. <FIG> shows that at least a portion of the interior wall defining the lumen <NUM> of the suture anchor <NUM> is hexagonal in cross-section. In the illustrated embodiment, a distal portion <NUM> (<FIG>) of an interior wall defining the lumen <NUM> may not have a female feature (e.g., a hexagonal-shaped female feature), configured to mate with the distal driver member <NUM>, formed therein. The distal driver member <NUM> of the driver device <NUM> extends through the lumen <NUM> of the suture anchor <NUM> such that the distal end 320d of the distal driver member <NUM> is disposed proximal to the distal end 310d of the suture anchor <NUM>. The distal portion <NUM> of the interior wall defining the lumen <NUM> of the suture anchor <NUM> can be circular in cross-section, which facilitates passage of a suture through a distal end of the lumen <NUM> of the suture anchor <NUM>.

As shown in <FIG>, the elongate shaft <NUM> has a central shaft portion <NUM> and a distal shaft portion <NUM> extending distally from a distal shoulder <NUM> and terminating at the distal end <NUM> of the elongate shaft <NUM>. However, it should be appreciated, the distal shoulder <NUM> may not be formed. The distal shaft portion <NUM> includes a distal awl tip portion <NUM>, which is distally tapered. The distal shaft portion <NUM> can have an outer diameter that is less than an outer diameter of the central shaft portion <NUM>.

In an assembled configuration, the elongate shaft <NUM> can be received within the lumen <NUM> of the driver device <NUM> such that a distal shaft portion <NUM> of the elongate shaft <NUM> and at least a part of the central shaft portion <NUM> of the elongate shaft <NUM> extend distally from the distal driver member <NUM>. The elongate shaft <NUM> can be removable from the lumen <NUM> of the driver device <NUM>. The distal end 302d of the elongate shaft <NUM> is configured to be inserted into bone to initiate a hole in the bone. Thus, there is no need to initiate a hole in the bone using other instruments.

As shown in <FIG>, the central shaft portion <NUM> of the elongate shaft <NUM> has a suture retaining feature <NUM> extending therethrough that is configured to seat at least one suture. As shown in <FIG>, the suture retaining feature <NUM> can extend from a distal end 326d of the central shaft portion <NUM>. In this example, the distal end 326d of the central shaft portion <NUM> coincides with the distal shoulder <NUM> of the central shaft portion <NUM>, though the central shaft portion <NUM> may not have such a distal shoulder. The suture retaining feature <NUM> can extend to a termination point within the central shaft portion <NUM> such that the suture retaining feature <NUM> communicates with the opening <NUM> extending through the side of the driver device <NUM>. As shown in <FIG>, the suture retaining feature <NUM> terminates approximately at a proximal end 317p of the opening <NUM> of the driver device <NUM>. However, the suture retaining feature <NUM> can terminate distally or proximally to the proximal end 317p of the opening <NUM>.

The suture retaining feature <NUM> of the central shaft portion <NUM> of the elongate shaft <NUM> can have any suitable configuration and can be formed in any suitable manner in the elongate shaft <NUM> so as to seat at least one suture therealong. The suture retaining feature <NUM> can be in the form of a groove formed along or parallel to a longitudinal axis of the elongate shaft <NUM> in an outer surface of the central shaft portion <NUM>. Alternatively, the suture retaining feature <NUM> can be in the form of a lumen or other feature.

The surgical system <NUM> includes the dilator feature <NUM> that is distal to the suture anchor <NUM>. The distal shaft portion <NUM> of the elongate shaft <NUM> is configured to extend through the dilator feature <NUM> such that the distal end 302d of the elongate shaft <NUM> extends distally from the dilator feature <NUM>. The dilator feature <NUM> is configured to facilitate insertion of the elongate shaft <NUM> into bone by widening a hole in bone once the hole is initiated, such as by the distal end 302d of the elongate shaft <NUM>. The dilator feature <NUM> is distally tapered. As shown in <FIG>, the dilator feature <NUM> can be in the form of a truncated pyramid shape with two or more triangular faces <NUM>. The faces <NUM> can be substantially flat, or they can be configured otherwise. The dilator feature <NUM> has three faces <NUM>, with each of the faces <NUM> having a groove <NUM> at a distal end of the face. Such a shape of the dilator feature <NUM> may facilitate its insertion into bone. It should be appreciated that the dilator feature <NUM> can have two or more than three faces. Also, the dilator feature <NUM> can be in form of a truncated cone, though the dilator feature <NUM> can have other suitable configurations.

The dilator feature <NUM> can be press-fit onto or otherwise releasably coupled with the elongate shaft <NUM>. The dilator feature <NUM> may lack surface features. Alternatively, the dilator feature <NUM> can have one or more surface features that facilitate its engagement with the bone. The dilator feature <NUM> can have any suitable dimensions. Furthermore, the dilator feature <NUM> can be implantable and it can be made from a non-metallic material. This can be beneficial since the properties of the dilator feature <NUM> are such that they do not interfere with imaging of the system <NUM>. Moreover, while it is sufficiently rigid to assist in forming a bone hole, the dilator feature <NUM> can be bioabsorbable and/or biodegradable. Alternatively, the dilator feature <NUM> can be made from a metal.

As shown in <FIG>, the surgical system <NUM> can have at least one suture <NUM> associated therewith that is used to attach tissue to bone. The suture <NUM> can be retained by the surgical system <NUM> such that terminal end portions 406a, 406b of the suture <NUM>, which can be coupled to issue, are passed through the lumen <NUM> of the suture anchor <NUM>, along the suture retaining feature <NUM> of the central shaft portion <NUM> of the elongate shaft <NUM>, and through the opening <NUM> extending through the side of the driver device <NUM>. As shown in <FIG>, the terminal end portions 406a, 406b of the suture <NUM> extend out of the opening <NUM>.

<FIG> illustrate the surgical system <NUM> used for a surgical repair method to attach soft tissue <NUM> (e.g., tendon) to bone <NUM>. It should be appreciated that the surgical repair method can be performed using other surgical systems, including surgical systems in which one or more components can be different from those included in the surgical system <NUM>.

<FIG> illustrates schematically (arrow <NUM>) that the terminal end portions 406a, 406b of the suture <NUM> are coupled to the system <NUM>. As discussed above, the terminal end portions 406a, 406b of the suture <NUM> can be passed through the lumen <NUM> of the suture anchor <NUM>, along the suture retaining feature <NUM> of the central shaft portion <NUM> of the elongate shaft <NUM>, and through the opening <NUM> extending through the side of the driver device <NUM>, as shown in <FIG>. <FIG> illustrates that the suture <NUM> can be coupled to the tissue <NUM>. For example, the suture <NUM> can be passed through or otherwise coupled to the tissue <NUM> such that the terminal end portions 406a, 406b of the suture <NUM> are free to engage with the system <NUM>.

<FIG> illustrates the surgical system <NUM> with the suture <NUM> loaded thereon. Tension can be applied to the suture <NUM>, as shown by an arrow <NUM>. While tension is maintained on the terminal end portions 406a, 406b of the suture <NUM>, the distal end 302d of the elongate shaft <NUM> is inserted into the bone <NUM> to initiate a hole in the bone <NUM> at a desired location in the bone <NUM>, as shown in <FIG>. The elongate shaft <NUM> is a self-punching shaft configured to initiate the hole such that no additional instrument is required. <FIG> also illustrates that, once the hole in the bone is initiated, a suitable instrument <NUM>, such as mallet, hammer, or other instrument, is used to drive the elongate shaft <NUM> further distally into the bone <NUM>. In this example, the instrument <NUM> can be used to apply force to a proximal end 340p of the proximal handle <NUM> coupled proximally to the elongate shaft <NUM> to thereby drive the distal end 302d of the elongate shaft <NUM> further into the bone <NUM>, as shown by an arrow <NUM>.

As the elongate shaft <NUM> is driven distally into the bone <NUM>, the dilator feature <NUM> widens the hole. Tension can be maintained on the terminal end portions 406a, 406b of the suture <NUM> as the distal end 302d of the elongate shaft <NUM> is inserted into the bone <NUM>, as shown by an arrow <NUM> in <FIG>. The distal end 302d of the elongate shaft <NUM> can be driven into bone <NUM> such that the distal shaft portion <NUM> of the elongate shaft <NUM> with the dilator feature <NUM> coupled thereto is inserted into the hole <NUM> in the bone <NUM>, as shown in <FIG> and <FIG>. A portion of the central shaft portion <NUM> of the elongate shaft <NUM> is also inserted into the hole <NUM>, whereas the suture anchor <NUM> is positioned at a desired position relative to the bone hole <NUM>. As shown in <FIG>, before being driven into the bone, the suture anchor <NUM> is positioned just proximal to the bone hole <NUM>. Alternatively, the suture anchor <NUM> can be at least partially inserted into the bone hole.

Once the distal end 302d of the elongate shaft <NUM> with the dilator feature <NUM> is driven into the bone <NUM> to a desired depth, the suture anchor <NUM> can be driven distally towards the dilator feature <NUM> and into the bone hole <NUM>. The driver device <NUM>, with the distal driver member <NUM> thereof releasably coupled to the suture anchor <NUM>, is activated to drive the suture anchor <NUM> distally into the bone hole <NUM>. As shown in <FIG>, the driver device <NUM> can be rotated, such as by rotating the proximal handle <NUM> of the driver device <NUM>, as shown by an arrow <NUM>. The rotation causes the suture anchor <NUM> to advance distally towards the dilator feature <NUM> and into the bone <NUM>, as shown in <FIG> and <FIG>. The threads <NUM> of the suture anchor <NUM> engage the bone <NUM>. As the driver device <NUM> is rotated, the elongate shaft <NUM>, which extends through the lumen <NUM> of the driver device <NUM> and the dilator feature <NUM>, remains stationary. For example, <FIG> illustrates that, after the device driver <NUM> has been driven distally, the proximal handle <NUM> of the driver device <NUM> is disposed offset from and more distal to the proximal handle <NUM> of the elongate shaft <NUM> than before the device driver <NUM> has been driven distally (e.g., <FIG>). The rotation of the device driver <NUM> causes the suture anchor <NUM> to move distally towards the distal feature <NUM> and into the bone <NUM>, which causes the suture <NUM> to be secured between an interior wall of the bone hole <NUM> and an outer surface of the suture anchor <NUM>.

Once the suture anchor <NUM> has been driven into the hole <NUM> in the bone <NUM>, the elongate shaft <NUM> can be separated from the dilator feature <NUM>, and the driver device <NUM> can be separated from the suture anchor <NUM>, as shown schematically by an arrow <NUM> in <FIG>. The elongate shaft <NUM> may not be coupled to the driver device <NUM>, and the elongate shaft <NUM> may be separated from the dilator feature <NUM> and removed from the lumen <NUM> of the driver device <NUM> before the driver device <NUM> is separated from the suture anchor <NUM>. In other embodiments, the elongate shaft <NUM> and the driver device <NUM> can be coupled to one another, and they can be separated from the dilator feature <NUM> and the suture anchor <NUM> substantially simultaneously. Regardless of the manner in which the elongate shaft <NUM> and the driver device <NUM> are removed, the dilator feature <NUM> and the suture anchor <NUM> with the suture <NUM> coupled thereto remain implanted in the bone hole <NUM>, thereby attaching the tissue <NUM> to the bone <NUM>, as shown in <FIG>. If desired, the terminal end portions 406a, 406b of the suture <NUM> can be trimmed using a suitable cutting instrument, and <FIG> illustrates by way of example the terminal end portions 406a, 406b trimmed. The terminal end portions 406a, 406b of the suture <NUM> can be passed through the tissue <NUM>, or the terminal end portions 406a, 406b can be coupled to another suture anchor.

Also disclosed but not covered by the claims is a surgical system that includes a pusher device, a driver device or driver, an elongate shaft, a suture anchor, and an implantable dilator feature. The pusher device has a proximal handle and a shaft extending therefrom, the shaft having a first lumen extending therethrough, and the pusher device having a first opening extending through a side thereof. The driver has a proximal handle and a shaft extending therefrom and having a second lumen extending therethrough, the shaft of the driver extending at least partially through the first lumen of the pusher device, and the driver having a second opening extending through a side thereof, the second opening communicating with the first opening. The elongate shaft can be proximally retractably disposed within the second lumen such that the elongate shaft can move between retracted and advanced configurations. At least one suture can be coupled to the surgical system when the elongate shaft is in the retracted configuration. The suture anchor having external threads formed thereon has a third lumen extending therethrough that removably receives therein a distal driver member of a driver shaft of the driver. The dilator feature can be removably disposed on the distal driver member distal to the suture anchor.

<FIG> illustrate a surgical system <NUM> that includes an overtube or pusher device <NUM>, an elongate shaft <NUM>, a driver device or driver <NUM> that receives the elongate shaft <NUM> at least partially therethrough, a suture anchor <NUM>, and a dilator feature <NUM> that can be implantable. The driver device <NUM> can have a proximal handle <NUM>. The pusher device <NUM> also can have a proximal handle <NUM> coupled to a proximal end thereof. As shown in <FIG>, the proximal handle <NUM> of the driver device <NUM> is disposed proximally to the handle <NUM> of the pusher device <NUM>. The elongate shaft <NUM> is coupled to a retraction mechanism <NUM> that is disposed in the proximal handle <NUM> of the driver <NUM>, the retraction mechanism <NUM> being configured to be activated to cause the elongate shaft <NUM> to move between a retracted configuration and an extended configuration, as discussed in more detail below.

The components of the system <NUM> can have various configurations. The pusher device <NUM>, configured to apply force to the suture anchor <NUM> as discussed below, can have various configurations. As shown in <FIG>, <FIG>, the pusher device <NUM> has a shaft <NUM> extending distally from the proximal handle <NUM> of the pusher device <NUM>. The shaft <NUM> of the pusher device <NUM> has a lumen <NUM> extending therethrough that receives the driver <NUM> therethrough. The pusher device <NUM> has an opening <NUM> extending through a side thereof.

The driver <NUM>, configured to drive the suture anchor <NUM> into bone, also can have various configurations. The driver <NUM> has a driver shaft <NUM> extending distally from the proximal handle <NUM> of the driver <NUM> and having a lumen <NUM> extending therethrough. As shown in <FIG>, the driver shaft <NUM> has a distal driver member <NUM> that extends from a point or feature within the drive shaft <NUM> to a distal end 520d of the distal driver member <NUM>, which is also a distal end of the driver shaft <NUM> of the driver <NUM>. For example, as shown in <FIG>, the driver shaft <NUM> can have a shoulder <NUM> proximal to the distal driver member <NUM> that extends from the shoulder <NUM> to the distal end 520d of the distal driver member <NUM>. The distal driver member <NUM> is configured to extend through the dilator feature <NUM> and through the suture anchor <NUM>, as shown in <FIG>.

The driver shaft <NUM> of the driver <NUM> extends at least partially through the lumen <NUM> of the pusher device <NUM>. Further, the driver <NUM> has in the driver shaft <NUM> thereof an opening <NUM> extending through a side of the driver shaft <NUM>. In an assembled configuration, as shown in <FIG>, <FIG>, <FIG>, and <FIG>, the opening <NUM> extending through the driver shaft <NUM> communicates with the opening <NUM> extending through the pusher device <NUM>.

The lumen <NUM> of the driver shaft <NUM> is configured to receive the elongate shaft <NUM> therethrough such that the elongate shaft <NUM> can be proximally retractably disposed within the lumen <NUM>. The elongate shaft <NUM> is configured to move between a retracted configuration in which a distal end 502d of the elongate shaft <NUM> is disposed proximally to the opening <NUM> of the driver shaft <NUM>, as shown in <FIG>, and an advanced configuration in which the distal end 502d of the elongate shaft <NUM> extends distally from a distal end 512d of the dilator feature <NUM>, as shown in <FIG>. In the retracted configuration, the elongate shaft <NUM> can be disposed proximally to at least a distal end 517d of a wall of the driver shaft <NUM> defining the opening <NUM> that extends between the distal end 517d of the wall and a proximal end 517p of the wall of the driver shaft <NUM>. As shown in <FIG>, the elongate shaft <NUM> can be disposed proximally to the proximal end 517p of the wall of the driver shaft <NUM> defining the opening <NUM>. The opening <NUM> of the pusher device <NUM> can have substantially the same length as a length of the opening <NUM> of the driver shaft <NUM>, or the opening <NUM> of the pusher device <NUM> can have a greater length than a length of the opening <NUM> of the driver shaft <NUM>. Regardless of the specific sizes of the opening <NUM> of the pusher device <NUM> and the opening <NUM> of the driver shaft <NUM>, the openings <NUM>, <NUM> are formed such that at least portions thereof are aligned to thereby allow a suture to pass from the lumen <NUM> of the driver shaft <NUM> and through both of the openings <NUM>, <NUM>.

The elongate shaft <NUM> can have a reduced outer diameter, which, for example, can be smaller than an outer diameter of elongate shaft <NUM> of <FIG>. In this way, the elongate shaft <NUM> can fit within the lumen <NUM> of the driver shaft <NUM> and allow one or more sutures to be passed along at least a portion of the elongate shaft <NUM> through the lumen <NUM> without a suture retaining feature being formed in the elongate shaft <NUM>. However, in some embodiments, a suture retaining feature in the form of a groove, channel, or other feature can be formed in the elongate shaft <NUM>.

The proximal handle <NUM> of the driver device <NUM> can have a variety of configurations. The proximal handle <NUM> includes the retraction mechanism <NUM> configured to be activated to cause the elongate shaft <NUM> to move between a retracted configuration and an advanced configuration. The retraction mechanism <NUM> can have various configurations. For example, as shown in <FIG>, the retraction mechanism <NUM> can include retaining first and second slots 521a, 521b communicating via a channel <NUM> in which a handle or lever <NUM> coupled to the elongate shaft <NUM> can be moved between the first, more distal slot 521a and between the more proximal slot 521b to thereby cause the elongate shaft <NUM> to move between advanced and retracted configurations, respectively. The lever <NUM>, which can have a knob or any other feature that facilitates grip, can be operably coupled to the elongate shaft <NUM> in any suitable manner. Furthermore, the elongate shaft <NUM> and the lever <NUM> can be integrally formed. It should be appreciated that the retraction mechanism <NUM> is shown by way of example only, as any suitable mechanism can be used additionally or alternatively to enable the elongate shaft <NUM> to move between the advanced and retracted configurations.

When the elongate shaft <NUM> is in the retracted configuration, as shown in <FIG>, the distal end 502d thereof can be disposed proximal to the distal end 517d of the wall of the driver shaft <NUM> defining the opening <NUM> of the driver shaft <NUM>. The distal end 502d of the elongate shaft <NUM> can be disposed proximal at least a portion of each of the openings <NUM>, <NUM> in the pusher tube <NUM> and the driver shaft <NUM> so as to allow at least one suture to be passed through a portion of the lumen <NUM> of the driver shaft <NUM>. With reference to <FIG>, when the elongate shaft <NUM> is absent from the portion of the lumen <NUM>, such portion, extending between the distal end 520d of the lumen <NUM> of the driver shaft <NUM> and a point within the lumen <NUM> where the distal end <NUM> of the elongate shaft <NUM> is disposed, can receive at least one suture <NUM> to therethrough. <FIG> illustrates the elongate shaft <NUM> in the retracted configuration and the suture <NUM> passed through the lumen <NUM> of the driver shaft <NUM> such that the suture <NUM> enters the lumen <NUM> from a distal end 512d of the dilator feature <NUM>, extends through a lumen <NUM> of the dilator feature <NUM>, through the lumen <NUM>, and exits the lumen <NUM> through the openings <NUM>, <NUM> of the pusher tube <NUM> and the driver shaft <NUM>, respectively. As shown, terminal end portions 606a, 606b of the suture <NUM> extends out of the opening <NUM> of the pusher tube <NUM>. Once the suture <NUM> is coupled to the system <NUM> as shown in <FIG>, the retraction mechanism <NUM> can be activated, such as by moving the lever <NUM> distally, to thereby cause the elongate shaft <NUM> to move distally. <FIG> shows the elongate shaft <NUM> in the advanced configuration in which the distal end 502d of the elongate shaft <NUM> extends distally from the distal end 512d of the dilator feature <NUM>.

The suture anchor <NUM> can have various configurations. The suture anchor <NUM> has one or more external threads <NUM> formed thereon configured to engage the suture anchor <NUM> with the bone. The suture anchor <NUM> can have any suitable configuration and can have other bone-engaging features. The suture anchor <NUM> can have a lumen <NUM> extending therethrough such that at least in a portion of the lumen <NUM> can receive therein the distal driver member <NUM> of the driver <NUM>. In an assembled configuration, as shown in <FIG>, the distal driver member <NUM> extends through the lumen <NUM> of the suture anchor <NUM> and further distally into the lumen <NUM> of the dilator feature <NUM> that is mounted on the distal driver member <NUM> distally to the suture anchor <NUM>. As shown in <FIG>, in an assembled configuration, a distal end of the pusher device <NUM> abuts a proximal end 510p of the suture anchor <NUM>. In this way, the pusher device <NUM> can be used to apply force to the suture anchor <NUM> when the suture anchor <NUM> is driven into bone, as discussed in more detail below.

The dilator feature <NUM> can also have various configurations. The dilator feature <NUM> is configured to facilitate insertion of the elongate shaft <NUM> into bone by widening a hole in the bone once the hole is initiated, such as by the distal end 502d of the elongate shaft <NUM>. The dilator feature <NUM> can be distally tapered and it can be in the form of a truncated cone, truncated pyramid having any suitable number of faces, etc. Similar to dilator feature <NUM> (FIGS. <NUM>- 10B) and dilator feature <NUM> (<FIG>), the dilator feature <NUM> can be implantable and it can be made from a non-metallic material, and the dilator feature <NUM> can be bioabsorbable and/or biodegradable. Alternatively, the dilator feature <NUM> can be made from a metal.

The distal driver member <NUM> of the driver <NUM> is configured to releasably mate with the suture anchor <NUM> and to thereby drive the suture anchor <NUM> mated thereto distally into bone. As shown in <FIG>, the distal driver member <NUM> also releasably mates with the dilator feature <NUM>. The distal driver member <NUM> can be in the form of a male feature configured to be received within a corresponding female feature formed on at least a portion of an interior wall defining the lumen of the suture anchor <NUM>. For example, the male feature can be hexagonal-shaped, and the corresponding female drive feature of the suture anchor <NUM> can be a corresponding hexagonal-shaped female feature formed in at least a portion of an interior wall defining the lumen <NUM> of the suture anchor <NUM>. In the illustrated embodiment, the distal driver member <NUM> extends through the entirety of the lumen <NUM> of the suture anchor <NUM>, and the entirety of the interior wall of the suture anchor <NUM> defining the lumen <NUM> can be configured to releasably mate with the distal driver member <NUM>. At least a portion of an interior wall defining the lumen <NUM> of the dilator feature <NUM> releasably mounted on the distal driver member <NUM> of the driver shaft <NUM> of the driver <NUM> can also be in the form of a female feature configured to releasably mate with the male drive feature of the distal driver member <NUM>. For example, at least a portion of the interior wall defining the lumen <NUM> of the dilator feature <NUM> can be hexagonal-shaped. It should be appreciated that the male feature of the distal driver member <NUM> and the corresponding female features of the suture anchor <NUM> and the dilator feature <NUM> can have any other configurations (e.g., square).

A distal portion <NUM> of the interior wall defining the lumen <NUM> adjacent to the distal end 512d of the dilator feature <NUM> may not have a female feature, such as a hexagonal, square, or other feature configured to mate with the distal driver member <NUM>. The distal portion <NUM> of the interior wall defining the lumen <NUM> of the of the dilator feature <NUM> can be circular in cross-section, which facilitates passage of a suture through the distal end 512d of the dilator feature <NUM>.

<FIG> illustrate the surgical system <NUM> used in a surgical repair method to attach soft tissue <NUM> (e.g., tendon) to bone <NUM>. It should be appreciated that the surgical repair method can be performed using other surgical systems, including surgical systems in which one or more components can be different from those included in the surgical system <NUM>.

<FIG> illustrates schematically (arrows <NUM>) that the terminal end portions 606a, 606b of the suture <NUM> are coupled to the system <NUM>. In <FIG>, the elongate shaft <NUM> is in the retracted configuration, as shown in <FIG>. The lever <NUM> of the retraction mechanism <NUM> of the proximal handle <NUM> of the driver <NUM> is disposed in the proximal slot 521b. In such a configuration, the suture <NUM> can be passed through the dilator feature <NUM>, through the lumen <NUM> of the distal driver member <NUM> extending through at least a portion of the dilator feature <NUM> and through the suture anchor <NUM>, and through the opening <NUM> of the driver <NUM> and the opening <NUM> of the pusher tube <NUM>, the openings <NUM>, <NUM> being at least partially aligned with one another. As shown in <FIG>, the suture <NUM> can be passed through or otherwise coupled to tissue <NUM> such that the terminal end portions 606a, 606b of the suture <NUM> can engage with the system <NUM>. It should be appreciated that in some embodiments the suture <NUM> can be coupled to tissue after the suture <NUM> has been coupled to the system <NUM>.

Once the suture <NUM> is associated with the system <NUM> as shown, for example, in <FIG>, the elongate shaft <NUM> can be moved to an advanced configuration. For example, the lever <NUM> of the retraction mechanism <NUM> can be moved distally, as shown in <FIG>, to thereby cause the elongate shaft <NUM> to advance distally. In this way, the elongate shaft <NUM> is positioned such that its distal end 502d extends distally beyond the dilator feature <NUM>, as shown in <FIG>. <FIG> illustrates the suture <NUM> being coupled to the system <NUM> and the elongate shaft <NUM> moved to the advanced configuration.

<FIG> illustrates the distal end 502d of the elongate shaft <NUM> inserted the bone <NUM> to initiate a hole at a desired location in the bone <NUM>. Tension can be applied to the suture <NUM> while the distal end 502d of the elongate shaft <NUM> is used to initiate a hole in the bone <NUM>. <FIG> also illustrates that, once the hole in the bone <NUM> is initiated, a suitable instrument <NUM>, such as mallet, hammer, or other instrument, is used to drive the elongate shaft <NUM> further distally into the bone <NUM>, as shown by an arrow <NUM>.

As the elongate shaft <NUM> is driven distally into the bone <NUM>, the dilator feature <NUM> widens the hole. Tension can be maintained on the terminal end portions 606a, 606b of the suture <NUM> as the distal end 502d of the elongate shaft <NUM> is inserted into the bone <NUM>. The elongate shaft <NUM> with the dilator feature <NUM> is driven into the bone <NUM> such that a hole <NUM> in the bone is formed and the dilator feature <NUM> releasably mounted on the distal driver member <NUM> of the driver shaft <NUM>, and at least a portion of the distal driver member <NUM>, are positioned in the hole <NUM>, as shown in <FIG>. The suture anchor <NUM> can sit above the surface of the bone <NUM>, just proximal to the bone hole <NUM>. The suture anchor <NUM> can be positioned partially within the hole <NUM> in the bone <NUM>.

After the elongate shaft <NUM> is driven into the bone <NUM> to a desired depth to form the hole <NUM>, the retraction mechanism <NUM> can be activated, such as by moving the lever <NUM> to from the distal slot 521a to the proximal slot 521b (as shown by an arrow <NUM> in <FIG>), which causes the elongate shaft <NUM> to be retracted, as also shown in <FIG>. <FIG> shows a distal portion of the system <NUM> with the elongate shaft <NUM> in the retracted configuration.

Once the elongate shaft <NUM> is in the retracted configuration, the suture anchor <NUM> can be driven distally towards the dilator feature <NUM> and into the bone hole <NUM>. The driver <NUM>, with the distal driver member <NUM> thereof releasably coupled to the suture anchor <NUM>, is activated to drive the suture anchor <NUM> distally into the bone hole <NUM>. As shown in <FIG>, the driver shaft <NUM> of device <NUM>, and therefore the distal driver member <NUM> of the shaft <NUM>, can be rotated, such as by rotating the proximal handle <NUM> of the driver <NUM>, as shown by an arrow <NUM>. During at least some of the rotation of the driver shaft <NUM> of the driver device <NUM>, force can be applied to the proximal handle <NUM> of the pusher device <NUM>, as shown by an arrow <NUM> in <FIG>. The system <NUM> can be configured such that a surgeon can use one hand to both rotate the driver <NUM> and apply force to the proximal handle <NUM> of the pusher device <NUM>. In this way, the suture anchor <NUM> is caused to rotatable move distally towards the dilator feature <NUM> and into the bone <NUM>, as threads <NUM> formed on the suture anchor <NUM> engage an interior wall of the hole <NUM> in the bone <NUM>. <FIG> illustrates the suture anchor <NUM> driven distally towards the dilator feature <NUM> and into the bone <NUM>. The suture <NUM> is secured between an interior wall of the bone hole <NUM> and an outer surface of the suture anchor <NUM>.

Once the suture anchor <NUM> has been positioned as desired within the hole <NUM> in the bone <NUM>, the driver <NUM> having the elongate shaft <NUM> coupled to the proximal handle <NUM> thereof can be separated from the dilator feature <NUM> and the suture anchor <NUM>, as shown by an arrow <NUM> in <FIG>. The pusher device <NUM> is also removed. As shown in <FIG>, the dilator feature <NUM> and the suture anchor <NUM> remain implanted in the bone hole <NUM>, thereby attaching the tissue <NUM> to the bone <NUM>, as shown in <FIG>. If desired, the terminal end portions 606a, 606b of the suture <NUM> can be trimmed using a suitable cutting instrument, and <FIG> illustrates by way of example the terminal end portions 606a, 606b trimmed.

The methods and systems described herein can have different variations. For example, multiple sutures can be used to couple tissue to bone. Also, one or more sutures can be loaded on a surgical system before or during a surgical procedure.

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 device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device, e.g., the shafts, can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device 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.

Preferably, the components of the system described herein will be processed before surgery. First, a new or used instrument is obtained and if necessary cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.

It is preferred the components are sterilized. 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).

Claim 1:
A surgical system (<NUM>), comprising:
a driver device (<NUM>) having a distal driver member (<NUM>);
an elongate shaft (<NUM>) having
a central shaft portion (<NUM>) having a suture retaining feature (<NUM>) extending therethrough proximal to a distal shoulder (<NUM>) of the central shaft portion (<NUM>), the suture retaining feature (<NUM>) communicating with an opening (<NUM>) extending through a side of the central shaft portion (<NUM>) proximal to the distal shoulder (<NUM>) of the central shaft portion (<NUM>);
a capture suture (<NUM>) extending through the suture retaining feature (<NUM>) of the central shaft portion (<NUM>) and the opening (<NUM>) such that terminal end portions (138a, 138b) of the capture suture (<NUM>) extend from a proximal end of the driver device (<NUM>) and the capture suture (<NUM>) forms a loop that extends through the opening (<NUM>);
a suture anchor (<NUM>) removably disposed on the distal driver member (<NUM>) of the driver device (<NUM>) having the elongate shaft (<NUM>) extending therethrough;
characterized in that the elongate shaft has a distal shaft portion (<NUM>) extending from the distal shoulder (<NUM>) of the central shaft portion (<NUM>) to a distal end of the elongate shaft (<NUM>); and
the surgical system comprises an implantable dilator feature (<NUM>) removably disposed on the distal shaft portion (<NUM>) distal to the suture anchor (<NUM>) such that the distal end of the elongate shaft (102d) extends distally from a distal end of the dilator feature (<NUM>).