Patent Description:
Tearing of, or complete or partial detachment of ligaments, tendons and/or other soft tissues from their associated bones within the body are commonplace injuries. Such injuries can 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 suture 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. In <CIT>, there are described implants and instruments for surgical transosseous attachment to a bone. In <CIT>, there is described an anchor system including an anchor including a threaded outer portion and a non-threaded outer portion and a plug disposed within the anchor, the plug comprising a distal portion, a proximal portion, the proximal portion comprising a threaded portion and a coupling portion, and a through hole. In <CIT>, there is described an anchor assembly including an anchor including a distal portion and a proximal portion, the anchor defining a cavity and an opening to the cavity; an insertion member disposed within the cavity of the anchor; and a sleeve coupled to the anchor, the sleeve disposed over the proximal portion of the anchor. <CIT> relates to endoscopic surgery and powered surgical instruments for use therein. It describes, in one embodiment depicted in Figures <NUM> to <NUM>, an endoscopic percussive driver for producing indentations in bony surfaces. Rotational motion of a device such as an arthroscopy shaver handpiece is converted into percussive energy usable for surgical applications.

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

Embodiments of the invention are defined by the appended dependent claims.

The system can vary in numerous ways. For example, the driver shaft can have a suture retaining feature extending longitudinally through a sidewall thereof and communicating with a suture retaining feature of the distal awl shaft extending longitudinally through a sidewall of the distal awl shaft. In some embodiments, the suture retaining feature of the distal awl shaft can be configured to receive at least one suture therethrough such that the suture received therethrough extends proximally through the suture anchor and through at least a portion of the suture retaining feature of the driver shaft.

In at least some embodiments, the proximal awl shaft can be a solid elongate member. In some embodiments, the system can further include a suture holding feature coupled to an outer wall of the driver shaft proximal to a distal end of the suture retaining feature of the driver shaft. In at least some embodiments, the suture holding feature can extend at least partially radially about the outer wall of the driver shaft.

In some embodiments, a distal end of the proximal awl shaft abuts a proximal end of the distal awl shaft in a configuration in which the system is used to form a hole in a bone. The distal end of the proximal awl shaft can be spaced apart from the proximal end of the distal awl shaft in a configuration in which the system is used to drive the suture anchor into the hole. In some embodiments, the proximal end of the distal awl shaft has a mating feature having a diameter that is greater than a diameter of a portion of the distal awl shaft extending from the mating feature. The distal end of the proximal awl shaft can abut the proximal end of the distal awl shaft such that, in the configuration in which the system is used to form the hole in the bone, the driver shaft is prevented from being driven distally relative to the distal awl shaft.

In some embodiments, the proximal awl shaft can have an awl handle coupled to a proximal portion thereof, the awl handle being configured to be activated to cause the proximal awl shaft to be retracted proximally away from the distal awl shaft. The awl handle can vary in many ways. For example, the awl handle can be disposed at least partially within the proximal handle of the driver, and the awl handle and the proximal handle of the driver can be independently movable. In some embodiments, the awl handle can have a trigger feature configured to be activated to cause the proximal awl shaft to be retracted proximally away from the distal awl shaft.

The driver can have various configurations. For example, the distal drive feature of the driver can have a hexagonal cross section.

In some embodiments, the surgical system can include a dilator feature that is distal to the suture anchor. The dilator feature can have a distal portion of the distal awl shaft at least partially extending therethrough such that at least a portion of a distal tip of the distal awl shaft extends distally from a distal end of the dilator feature.

A method of performing a surgical repair, not part of the present invention, but which can be performed with the system of the present invention, includes advancing a distal end of a distal awl shaft into a bone to form a bone hole, a proximal end of the distal awl shaft abutting a distal end of a proximal awl shaft such that the proximal awl shaft applies a load to the proximal end of the distal awl shaft. The method further includes, after the bone hole has been formed, moving the proximal awl shaft to a retracted configuration such that the distal end of the proximal awl shaft is spaced apart from the proximal end of the distal awl shaft. With the proximal awl shaft in the retracted configuration, the method can further include driving a suture anchor having a suture coupled thereto distally into the bone hole and thereby securing the suture between an inner wall of the bone hole and an outer surface of the suture anchor.

The method can have a number of variations. For example, moving the proximal awl shaft to the retracted configuration can include activating a handle coupled to a proximal portion of the proximal awl shaft. As another example, the distal awl shaft can extend through an implantable dilator feature, through the suture anchor positioned proximal to the dilator feature, and through a portion of a driver shaft, wherein driving the suture anchor distally into the bone hole comprises driving the suture anchor distally towards the dilator feature. As a further example, the method can include applying tension on a terminal end portion of the suture while the proximal awl shaft is moved to the retracted configuration.

The terminal end portion of the suture can be passed through a suture retaining feature of the distal awl shaft, through a lumen of the suture anchor, and through at least a portion of a suture retaining feature of the driver shaft, the terminal end portion extending from the driver 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, which is defined by claim <NUM>.

Various methods and devices are provided for securing tissue to bone. In at least some of the described embodiments, a surgical system is provided that can include a driver device or driver, a distal awl shaft, a proximal awl shaft, and a suture anchor. The driver can have a proximal handle and a driver shaft extending therefrom, the driver shaft having a lumen extending therethrough. The proximal awl shaft is separate from the distal awl shaft and is movable proximally with respect to the distal awl shaft. The distal and proximal awl shafts can be receivable in the lumen of the driver such that a portion of the distal awl shaft extends distally from a distal end of the driver shaft and the proximal awl shaft is disposed within the lumen of the driver. The suture anchor has a lumen extending therethrough that removably receives the distal awl shaft. A distal driver feature of the driver shaft is operably coupled to the suture anchor such that the driver shaft can be rotated to cause the suture anchor to be driven distally into a bone. In some embodiments, the surgical system can also include a dilator feature distal to the suture anchor. The dilator feature can have a distal portion of the distal awl shaft at least partially extending therethrough such that at least a portion of a distal tip of the distal awl shaft extends distally from a distal end of the dilator feature.

In the illustrated embodiments, the surgical system can have a first configuration in which the system is used to form a bone hole and a second configuration in which the system is used to drive a suture anchor into the bone hole. In the first, bone hole forming configuration, a distal end of the proximal awl shaft abuts a proximal end of the distal awl shaft. In this way, when the surgical system is driven into a bone by applying a load to its proximal end (e.g., by using a mallet or other suitable instrument), the proximal awl shaft applies a load to the distal awl shaft. Also, in this configuration, the driver shaft can be prevented from moving distally relative to the distal awl shaft. After the system has been used to form a bone hole, as discussed in more detail below, the proximal awl shaft can be retracted proximally such that the distal end of the proximal awl shaft becomes spaced apart from the proximal end of the distal awl shaft. For example, an awl handle coupled to a proximal portion of the proximal awl shaft can be operated to cause the proximal awl shaft to be moved proximally. Once the proximal awl shaft has been moved proximally, the surgical system can be used to drive the suture anchor into the bone.

<FIG> and <FIG> illustrate one embodiment of a surgical system <NUM> that includes a driver device or driver <NUM> having a proximal handle <NUM> and a driver shaft <NUM> extending therefrom, a distal awl shaft <NUM>, a proximal awl shaft <NUM> that is separate from the distal awl <NUM>, a suture anchor <NUM>, and a dilator feature <NUM> that can be implantable. The system <NUM> also includes an awl handle <NUM> coupled to the proximal awl shaft <NUM> and extending at least partially proximally from the proximal handle <NUM>, as shown in <FIG>. The driver shaft <NUM> can have a lumen <NUM> extending longitudinally therethrough, as shown in <FIG>. The lumen <NUM> of the driver shaft <NUM> is configured to receive at least partially therethrough the distal awl shaft <NUM> such that a portion of the distal awl shaft <NUM> extends distally from a distal end of the driver shaft <NUM> and the proximal awl shaft <NUM> is disposed within the lumen <NUM> proximal to the distal awl shaft <NUM>, as also shown in <FIG>.

The proximal handle <NUM> has a lumen <NUM> extending along a length thereof and communicating with the lumen <NUM> of the driver shaft <NUM>. The lumen <NUM> of the driver shaft <NUM> and the lumen <NUM> of the proximal handle <NUM> provide a lumen that is configured to receive the proximal awl shaft <NUM> therethrough, as shown in <FIG>, <FIG>, <FIG>. A proximal end 110p of the proximal awl shaft <NUM> can protrude proximally from the proximal end of the awl handle <NUM>. However, in other embodiments, the proximal end 110p may not protrude from the proximal end of the awl handle <NUM>. As shown in <FIG>, the surgical system <NUM> has a suture holding feature <NUM> coupled to an outer wall of the driver shaft <NUM>.

The suture anchor <NUM>, which can have external threads <NUM> formed thereon, has a lumen <NUM> extending therethrough that removably receives the distal awl shaft <NUM>. A distal driver feature of the driver shaft <NUM> is operably coupled to the suture anchor, as discussed in more detail below. The dilator feature <NUM>, which is distal to the suture anchor <NUM>, has a distal portion of the distal awl shaft <NUM> at least partially extending therethrough such that at least a portion of a distal tip 108d of the distal awl <NUM> shaft extends distally from a distal end 114d of the dilator feature <NUM>, as shown, for example, in <FIG>, <FIG> and <FIG>. It should be appreciated that a dilator feature may not be present in some implementations.

As shown in <FIG>, the proximal awl shaft <NUM> has the awl handle <NUM> coupled to a proximal portion thereof such as, for example, the portion of the proximal awl shaft <NUM> extends through a bore in the awl handle <NUM>. The proximal awl shaft <NUM> is non-movably coupled to the awl handle <NUM> that is configured to be activated to cause the proximal awl shaft <NUM> to be retracted proximally away from the distal awl shaft <NUM>. In the illustrated embodiment, the awl handle <NUM> is disposed at least partially within the proximal handle <NUM> of the driver <NUM>, and the awl handle <NUM> and the proximal handle <NUM> of the driver <NUM> can be independently movable, as discussed in more detail below. The proximal awl shaft <NUM> can be coupled to the awl handle <NUM> in many various ways, for example, by press-fit, by adhesive, glue, by ultrasonic welding, etc..

The components of the system <NUM> can have various configurations. Thus, the distal and proximal awl shafts <NUM>, <NUM> can have many variations. As shown in <FIG>, <FIG>, and <FIG>, the distal awl shaft <NUM> is a generally cylindrical elongate member having a central portion <NUM> and a distal portion <NUM> extending distally from the central portion <NUM>. At least a portion of the distal awl shaft <NUM> can have a suture retaining feature <NUM> extending longitudinally through a sidewall thereof. For example, in the illustrated embodiment, the suture retaining feature <NUM> extends from (and through) a portion of a proximal end 124p of the distal portion <NUM> to a proximal end 122p of the central portion <NUM>, which coincides with a proximal end 108p of the distal awl shaft <NUM>. As shown in <FIG>, the suture retaining feature <NUM> has a proximal opening at the proximal end 108p of the distal awl shaft <NUM>. As also shown in <FIG>, in the illustrated embodiment, a distal end 126d of the suture retaining feature <NUM> is disposed just distal to the proximal end 124p of the distal awl shaft's distal portion <NUM>.

In some embodiments, the proximal end of the distal awl shaft <NUM> can have a larger diameter than a distal end of the proximal awl shaft <NUM>. In the illustrated embodiment, the proximal end 108p of the distal awl shaft <NUM> includes a mating feature <NUM> having a diameter that is greater than a diameter of a portion of the distal awl shaft extending from the mating feature. In particular, as shown in <FIG>, the diameter of the mating feature <NUM> is greater than the diameter of the rest of the central portion <NUM> of the distal awl shaft <NUM>. As also shown in <FIG>, the distal portion <NUM> of the distal awl shaft <NUM> has a diameter that is less than the diameter of the central portion <NUM>.

As shown in <FIG>, the proximal awl shaft <NUM> can be a generally cylindrical elongate member. The proximal awl shaft <NUM> extends through the lumen <NUM> of the driver <NUM> such that a proximal end 110p the proximal awl shaft <NUM> extends from a proximal end 120p of the awl handle <NUM>. The system <NUM> is used to initiate a hole in bone and, once the bone hole is formed, to drive the suture anchor into the hole. In the illustrated embodiments, as shown in <FIG> and <FIG>, a distal end 110d of the proximal awl shaft <NUM> abuts the proximal end 108p of the distal awl shaft <NUM> in a configuration in which the system <NUM> is used to form a hole in a bone. The system <NUM> can be configured such that, in the bone hole forming configuration, the proximal awl shaft <NUM> is biased against the distal awl shaft <NUM> such that the driver shaft <NUM> is prevented from being moved distally relative to the distal awl shaft <NUM>.

When load is applied to the proximal awl shaft <NUM> during initiation of the hole, the proximal awl shaft <NUM> applies load to the distal awl shaft <NUM> the distal end 108d of which is inserted into the bone. Thus, the distal and proximal awl shafts <NUM>, <NUM> act together to allow the system <NUM> to operate as a self-punching shaft used to initiate a hole in the bone. Thus, no additional instruments may be required to initiate the hole. Once the hole in the bone is initiated, the distal end 108d of the distal awl shaft <NUM> can be driven further distally into the hole by further applying load to the proximal awl shaft <NUM>. The dilator feature <NUM>, which can be implantable, can assist in widening the hole in the bone as the hole is being formed.

Once the bone hole is formed, the proximal awl shaft <NUM> is retracted proximally from the distal awl shaft <NUM>, for example, by activating the awl handle <NUM> coupled to the proximal awl shaft <NUM> as shown in <FIG> which are discussed in more detail below. The distal end 108d of the distal awl shaft <NUM> remains in the bone hole and the suture anchor <NUM> can be driven over the distal awl shaft <NUM> without being hindered by the proximal awl shaft <NUM>. Also, moving the proximal awl shaft <NUM> such that its distal end 110d is spaced apart from the proximal end 108p of the distal awl shaft <NUM> allows the proximal awl shaft <NUM> to be out of the way of the suture when the suture anchor <NUM>, having the suture coupled thereto, is driven into the bone. This configuration avoids a possibility of the suture wrapping around the proximal awl shaft during insertion of the suture anchor, which could occur when a one-piece awl shaft is used instead of the distal and proximal awl shafts described herein.

The driver <NUM> that is configured to drive the suture anchor <NUM> into bone can have various configurations. The driver shaft <NUM> can be coupled to the proximal handle <NUM> in various ways. As shown in <FIG>, the driver shaft <NUM> has a central portion <NUM> having a shoulder <NUM> at a distal surface thereof. The shoulder <NUM> is proximal to a distal driver member <NUM> that extends from the shoulder <NUM> to a distal end 132d of the distal driver member <NUM>. The distal end 132d is also a distal end 106d of the driver shaft <NUM> of the driver <NUM>. The distal driver member <NUM> has the suture anchor <NUM> mounted thereon. In the illustrated embodiment, the driver shaft <NUM> has a neck feature <NUM> disposed between the shoulder <NUM> and the distal driver member <NUM> such that the neck feature <NUM> abuts a proximal end 112p 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 lumen <NUM> of the driver shaft <NUM> receives the distal awl shaft <NUM> such that a proximal portion of the distal awl shaft <NUM> is seated within the lumen <NUM>. For example, as shown in <FIG>, the distal awl shaft <NUM> is received within the driver shaft's lumen <NUM> such that the mating feature <NUM> of the distal awl shaft <NUM> is seated proximal to the distal driver feature <NUM> of the driver shaft <NUM>. A distal surface 128d of the mating feature <NUM> abuts a proximal surface 134p of an inner shoulder <NUM> disposed within the driver shaft's lumen <NUM> proximal to the shoulder <NUM> of the driver <NUM>.

Further, in the illustrated embodiment, the driver shaft <NUM> of the driver <NUM> has a suture retaining feature <NUM> extending longitudinally through a sidewall thereof. The suture retaining feature <NUM>, which can be in the form of a slot, communicates with the suture retaining feature <NUM> of the distal awl shaft <NUM>, as shown, for example, in <FIG>. In the illustrated embodiment, the suture retaining feature <NUM> of the driver shaft <NUM> can be in the form of a longitudinal slot that opens into the lumen <NUM> of the driver shaft <NUM>. As shown in <FIG>, the suture retaining feature <NUM> extends along the length of the driver shaft <NUM> between its distal and proximal ends 136d, 136p. In this example, the distal end 136d of the suture retaining feature <NUM> is proximal to the shoulder <NUM> and the proximal end 136p is distal to the proximal end 106p of the driver shaft <NUM>. It should be appreciated that the suture retaining feature <NUM> can be formed in other ways in the driver shaft <NUM>.

As shown in <FIG>, a suture <NUM> (which can be in the form of two or more suture strands) can be passed as shown by arrow <NUM> - such that suture's terminal end portion <NUM> is passed through the suture retaining feature <NUM> of the distal awl shaft <NUM>, through the lumen <NUM> of the suture anchor <NUM> (which has the distal awl shaft <NUM> extending therethrough) and through at least a portion of the suture retaining feature <NUM> of the driver shaft <NUM>. The terminal end portion <NUM> of the suture <NUM> extends from the driver shaft <NUM> as shown in <FIG>. As also shown, the terminal end portion <NUM> extends from the driver shaft <NUM> proximally to the suture holding feature <NUM> coupled to the outer wall of the driver shaft <NUM> proximal to the distal end 136d of the suture retaining feature <NUM> of the driver shaft <NUM>. The suture holding feature <NUM> which can, for example, extend at least partially radially about the outer wall of the driver shaft <NUM>, allows, in use, maintaining a position of the suture <NUM> while preventing suture wrapping within the driver shaft <NUM>. Also, in an arthroscopic procedure, the suture holding feature <NUM> facilitates directing the terminal end <NUM> of the suture <NUM> out of a cannula through which the system <NUM> (and other instruments) can be inserted to access a surgical site.

The suture holding feature <NUM> can have various configurations and it be coupled to the driver shaft <NUM> in a variety of ways. For example, the suture holding feature <NUM> can be in the form of a ring, or it can have a semi-circular shape. It can be non-movably attached to the driver shaft <NUM>. In some embodiments, however, the suture holding feature <NUM> can be movable with respect to the driver shaft <NUM>, though it is coupled to the driver shaft <NUM> such that its position with respect to the shaft <NUM> can be adjustable. For example, the suture holding feature <NUM> can be configured to be slidably attached to the driver shaft <NUM>, e.g., via friction fit or in other ways, such as a position of the suture holding feature <NUM> with respect to the driver shaft <NUM> can be adjusted and, once adjusted, maintained. The suture holding feature <NUM> can be attached to the driver shaft <NUM> removably or, in some implementations, it can be permanently fixed to the shaft driver shaft. In at least one embodiment, the suture holding feature <NUM> can have an opening on a side thereof such that the feature <NUM> can be snapped on or otherwise removably coupled to the driver shaft <NUM>.

The suture holding feature <NUM> can be coupled to the driver shaft <NUM> such that the suture holding feature <NUM> seats above a cannula which can be used in a surgical procedure. For example, in use, the system <NUM> can be inserted to a surgical site through the cannula, and the suture holding feature <NUM> can then be slidably or otherwise attached to the driver shaft <NUM>.

The suture anchor <NUM> can have various configurations. In the illustrated embodiment, as mentioned above, the suture anchor <NUM> has at least one external thread <NUM> formed thereon that is configured to engage the suture anchor <NUM> with the bone. However, the suture anchor <NUM> can have any suitable configuration and can have other bone-engaging features. For example, in some embodiments, the suture anchor can be a screw-in anchor. In some embodiments, the suture anchor can be a push-in style suture anchor.

As shown in <FIG>, the suture anchor <NUM> has the lumen <NUM> extending therethrough such that at least a portion of the lumen <NUM> can receive therein the distal driver member <NUM>. In an assembled configuration, as shown in <FIG> and <FIG>, the distal driver member <NUM> extends through the lumen <NUM> of the suture anchor <NUM> such that the distal end 132d of the distal driver member <NUM> is disposed proximal to a distal end 112d of the suture anchor <NUM>. However, in other embodiments, the distal end 132d of the distal driver member <NUM> can be aligned with or can extend beyond the distal end 112d of the suture anchor <NUM>. As shown in <FIG>, the lumen <NUM> of the suture anchor <NUM> also receives therethrough the distal awl shaft <NUM> that extends through the distal driver member <NUM>.

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 (over the distal awl shaft <NUM>), 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 formed on at least a portion of an interior wall defining the lumen of the suture anchor <NUM>.

In the illustrated embodiment, as shown in <FIG>, the distal driver member <NUM> can be in the form of a male feature that 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> and <FIG>) of the interior wall defining the suture anchor's lumen <NUM> may be circular in cross-section such that it does not have the hexagonal feature. In this embodiment, the distal driver member <NUM> of the driver <NUM> extends through the lumen <NUM> of the suture anchor <NUM> such that the distal end 132d of the distal driver member <NUM> is disposed proximal to the distal end 112d of the suture anchor <NUM>. The distal portion <NUM> of the interior wall defining the lumen <NUM> of the suture anchor <NUM> is circular in cross-section, which facilitates passage of a suture through a distal end of the lumen <NUM> of the suture anchor <NUM>. The circular cross-sectional shape of the distal portion <NUM> of the lumen <NUM> also helps prevent suture tangling around the distal end of the suture anchor <NUM>.

In the illustrated embodiment, as shown in <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG>, the surgical system <NUM> includes the dilator feature <NUM> that is distal to the suture anchor <NUM>. The distal awl shaft <NUM> is configured to extend through a lumen of the dilator feature <NUM> such that the distal end 108d of the distal awl shaft <NUM> extends distally from the dilator feature <NUM>, as shown, for example, in <FIG>. The dilator feature <NUM> is configured to facilitate insertion of the distal awl shaft <NUM> into bone by widening a hole in bone once the hole is initiated, such as by the distal end 108d of the distal awl shaft <NUM>. The dilator feature <NUM> can be distally tapered and it can be in the form of a truncated cone or pyramid. In the illustrated example, as shown in <FIG>, the dilator feature <NUM> can have a proximal neck portion <NUM> that has substantially the same diameter along its length, and a distal portion <NUM> that extends distally from the proximal neck portion <NUM> and that is distally tapered. An outer wall of the distal portion <NUM> of the dilator feature <NUM> can be conical without any surface features. In some embodiments, however, at least a portion of the dilator feature can have two or more faces, which can be, for example, triangular. For example, in one embodiment, the dilator feature can have three faces. The faces can be substantially flat or they can have other configurations and features that facilitate insertion of the dilator feature into bone. It should be appreciated that the dilator feature <NUM> can have any suitable configurations.

The dilator feature <NUM> can be press-fit onto or otherwise releasably coupled with the distal awl shaft <NUM> and it can have any suitable dimensions. Furthermore, 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 non-metallic materials are such that they would not interfere with post-implantation imaging of the repair done using 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.

The proximal handle <NUM> of the driver <NUM> can have a variety of configurations. In the illustrated embodiment, as shown in <FIG> and <FIG>, the lumen <NUM> of the proximal handle <NUM> receives a proximal portion of the driver shaft <NUM> such that the lumen <NUM> communicates with the lumen <NUM> of the driver shaft <NUM>. In this way, the lumens <NUM> and <NUM> receive the proximal awl shaft <NUM> therethrough. The driver shaft <NUM> is coupled to the proximal handle <NUM> in any 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 <NUM> can be configured to have surface features that facilitate grip during use of the system <NUM>. For example, as shown in <FIG>, the proximal handle <NUM> has one or more grooves <NUM> formed along its length. It should be appreciated, however, that the proximal handle <NUM> can have any suitable surface features, as the described embodiments are not limited in this respect.

The proximal handle <NUM> of the driver <NUM> can be coupled to the awl handle <NUM>, which is coupled to the proximal awl shaft <NUM>. For example, as shown in <FIG> and <FIG>, the lumen <NUM> of the proximal handle <NUM> is configured to receive the awl handle <NUM> at least partially therein. Thus, the lumen <NUM> of the proximal handle <NUM> has a distal portion <NUM> configured to receive the proximal portion of the driver shaft <NUM>, and a proximal portion <NUM> configured to receive at least part of the awl handle <NUM> therein. As shown in <FIG> and <FIG>, the proximal portion <NUM> of the proximal handle's lumen <NUM> can have a larger diameter than the distal portion <NUM> of the lumen <NUM> and the proximal portion <NUM> has a configuration corresponding to a configuration of the awl handle <NUM>. The proximal portion <NUM> of the lumen <NUM> communicates with openings <NUM> in the proximal handle <NUM>. As shown in <FIG> and <FIG>, the proximal portion <NUM> of the proximal handle's lumen <NUM> includes pins <NUM> or other features configured to retain a position of the awl handle <NUM> (e.g., its tabs <NUM>).

As shown in <FIG>, the awl handle <NUM> has a distal portion <NUM>, a central portion <NUM>, and a proximal portion <NUM>. The distal, central, and proximal portions <NUM>, <NUM>, <NUM> of the awl handle <NUM> are generally cylindrical, with the distal portion <NUM> having a diameter smaller than that of the central portion <NUM>, and the central portion <NUM> having a diameter smaller than a diameter of the proximal portion <NUM>. The distal and central portions <NUM>, <NUM> of the awl handle <NUM> are received in the proximal portion <NUM> of the lumen <NUM> of the proximal handle <NUM>, and the proximal portion <NUM> of the awl handle <NUM> protrudes beyond the proximal end 104p of the proximal handle <NUM>, as shown in <FIG> and <FIG>. As also shown in <FIG> and <FIG>, the proximal portion <NUM> of the lumen <NUM> can be shaped similarly to the distal and central portions <NUM>, <NUM> of the awl handle <NUM> seated therein. Thus, in this example, the proximal portion <NUM> of the lumen <NUM> of the proximal handle <NUM> has a distal part having a diameter that is less than a diameter of a proximal part.

In the illustrated embodiment, the central portion <NUM> of the awl handle <NUM> has tabs <NUM> extending therefrom, as shown in <FIG>, <FIG>, <FIG>, and <FIG>. The tabs <NUM> can be in the form of ribs, wings, or they can be any other features. In the bone hole forming configuration of the system <NUM>, the tabs <NUM> of the of the awl handle <NUM> protrude from the slots <NUM> of the proximal handle <NUM> and thereby prevent the awl handle <NUM> (and thus the proximal awl shaft <NUM> coupled there) from moving with respect to the proximal handle <NUM>. In the illustrated embodiment, the proximal portion <NUM> of the lumen <NUM> of the proximal handle <NUM> includes a spring <NUM> (shown in <FIG>) configured to bias the awl handle <NUM> proximally when the awl handle <NUM> is released from engagement with the proximal handle <NUM>, such as the tabs <NUM> disengage from the openings <NUM> in the proximal handle as shown in <FIG>. Thus, in the bone hole forming configuration of the system <NUM>, the spring <NUM>, which can extend along a length of the proximal portion <NUM> of the lumen <NUM>, can be in at least partially compressed configuration.

The proximal portion <NUM> of the awl handle <NUM>, which is positioned proximal to the proximal end 104p of the proximal handle <NUM>, is configured to be grasped by a user (e.g., a surgeon) to cause the proximal awl shaft <NUM> to be retracted proximally. The proximal portion <NUM> can have any suitable surface features that facilitate gripping.

In use, in the configuration in which the system <NUM> is used to form a hole in bone, the proximal awl shaft <NUM> is disposed such that its distal end 110d abuts the proximal end 108p of the distal awl shaft <NUM>. In such a configuration, the driver <NUM> is prevented from being driven distally relative to the distal awl shaft, because of the engagement between the driver's proximal handle <NUM> and the awl handle <NUM>. To move the system <NUM> into the configuration in which it can be used to drive the suture anchor into the bone hole, the awl handle <NUM> can be activated. For example, in the illustrated example, the awl handle <NUM> can be rotated by grasping and rotating the proximal portion <NUM> to cause the tabs <NUM> of the awl handle <NUM> to rotate and enter the lumen <NUM> of the proximal handle <NUM> via the slots <NUM>. In this way, as shown in <FIG>, once the tabs <NUM> no longer engage the slots <NUM> of the proximal handle <NUM>, the awl handle <NUM>, with assistance of the biasing spring <NUM> disposed in the proximal portion <NUM> lumen <NUM> of the proximal handle <NUM>, is caused to move proximally such that the central portion <NUM> of the awl handle <NUM> is protruded proximally beyond the proximal end 104p of the proximal handle <NUM>.

As shown in <FIG>, the tabs <NUM> of the awl handle <NUM> can abut distally the pins <NUM> in the proximal portion <NUM> of the proximal handle's lumen <NUM>, thereby the awl handle <NUM> is prevented from moving further proximally. In this way, the position of the pins <NUM> within the lumen <NUM> can determine a distance to which the awl handle <NUM> is allowed to move proximally. It should be appreciated that in this, as well as in other embodiments described herein, the surgical system can be configured such that a proximal awl shaft can be moved proximally with respect to a distal awl shaft to a predetermined distance. In other words, once the awl handle of the proximal awl shaft is activated, the proximal awl shaft is automatically moved to a desired distance, and no additional action (e.g., by the surgeon) may be required to control how far the proximal awl shaft moves.

When the awl handle <NUM> is disengaged from the proximal handle <NUM>, the spring <NUM> can move from the at least partially compressed configuration to the less compressed configuration such that it helps bias the awl handle <NUM> proximally and to maintain the awl handle <NUM> in such position.

The proximal movement of the awl handle <NUM> causes the proximal awl shaft <NUM>, which is coupled thereto, to move proximally away from the distal awl shaft <NUM>. Thus, <FIG> illustrates that the distal end 110d of the proximal awl shaft <NUM> is spaced from the proximal end 108p of the distal awl shaft <NUM>. It should be appreciated that, although <FIG> shows the distal end 110d of the proximal awl shaft <NUM> disposed distal to the suture holding feature <NUM>, in some implementations, the proximal awl shaft <NUM> can be retracted proximally such that its distal end 110d is disposed proximally to the suture holding feature <NUM>. Also, although not shown in <FIG>, <FIG>, <FIG>, in use, the system <NUM> has a suture coupled thereto, such as shown, for example, in <FIG>. After the proximal awl shaft <NUM> is retracted proximally, the proximal handle <NUM> can be rotated to drive the suture anchor <NUM> into the bone hole.

<FIG> illustrate a method of performing a surgical repair involving use of a surgical system, such as the surgical system <NUM> (shown by way of example only), to attach soft tissue <NUM> (e.g., tendon) to bone <NUM>. It should be appreciated that the surgical repair method in accordance with the described embodiments 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 terminal end portions 240a, 240b of a suture <NUM> (which is similar to suture <NUM> of <FIG>) are coupled to the system <NUM> which is in the bone hole forming configuration. <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 240a, 240b of the suture <NUM> are free to engage with the system <NUM>. It should be appreciated that in some embodiments the suture <NUM> may be pre-loaded onto the system, or the suture <NUM> may be passed through or otherwise coupled to the tissue <NUM> after being anchored in the bone using the system <NUM>.

As discussed above in connection with suture <NUM> shown by way of example in <FIG>, the terminal end portions 240a, 240b of the suture <NUM> can be passed (arrow <NUM>) through the suture retaining feature <NUM> of the distal awl shaft <NUM> and through the lumen <NUM> of the suture anchor <NUM>, and along the suture retaining feature <NUM> of the driver shaft <NUM>. The terminal end portions 240a, 240b of the suture <NUM> are passed along a portion of the suture retaining feature <NUM> (e.g., slot) of the driver shaft <NUM> such that the terminal end portions 240a, 240b are passed under the suture holding feature <NUM>, as shown in <FIG> illustrating the surgical system <NUM> with the suture <NUM> loaded thereon. In this way, the terminal end portions 240a, 240b of the suture <NUM> extend from the shaft <NUM>, as also shown in <FIG>.

After the surgical system <NUM> with the suture <NUM> as shown in <FIG>, the distal end 108d of the distal awl shaft <NUM> is inserted into the bone <NUM> to initiate a hole in the bone <NUM> at a desired location, as shown in <FIG>. Tension is applied to the suture <NUM> after the distal end 108d of the distal awl shaft <NUM> is inserted into the bone <NUM> to form the hole <NUM>. In the illustrated embodiments, the distal awl shaft <NUM>, which has the proximal awl shaft <NUM> abutting thereto as discussed above, is a self-punching shaft configured to initiate and create the hole in the bone such that no additional instrument is required. Once the hole in the bone is initiated, the distal awl shaft <NUM> is driven further distally into the bone <NUM> to form a bole hole <NUM>. In particular, as shown in <FIG> by arrow <NUM>, a suitable instrument <NUM>, such as mallet, hammer, or other instrument, is used to apply force to the proximal end 110p of the proximal awl shaft <NUM> that, in turn, applies load to the distal awl shaft <NUM> to thereby cause the distal awl shaft <NUM> to drive distally into the bone <NUM>. As the distal awl shaft <NUM> is driven distally into the bone <NUM>, the dilator feature <NUM> widens the hole <NUM>. Tension can be applied to the terminal end portions 240a, 240b of the suture <NUM> after the distal end 108d of the distal awl shaft <NUM> is inserted into the bone <NUM>, as shown by arrow <NUM> in <FIG>. The tensioning of the terminal suture portions 240a, 240b allows bringing the tissue <NUM> closer to the location of the bone hole <NUM>, as shown schematically in <FIG> where the tissue <NUM> is disposed closer to the bone hole <NUM> than in <FIG> in which the location of the bone hole <NUM> to be formed is shown.

The distal end 108d of the distal awl shaft <NUM> is driven into bone <NUM> such that the dilator feature <NUM> coupled thereto is inserted into the hole <NUM> in the bone <NUM>, as shown in <FIG>. A portion of the distal awl 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>. In the illustrated embodiment, as shown in <FIG>, before being driven into the bone, the distal end of the suture anchor <NUM> is positioned at the proximal edge of the bone hole <NUM>. In other embodiments, the suture anchor <NUM> can be partially inserted into the bone hole.

Once the distal end 108d of the distal awl shaft <NUM> with the dilator feature <NUM> is driven into the bone <NUM> to a desired depth, the proximal awl shaft <NUM> is moved proximally away from the distal awl shaft <NUM>. Accordingly, <FIG> shows that the awl handle <NUM> is actuated (i.e., rotated) grasping and rotating its proximal portion <NUM> (as shown by arrow <NUM>) to thereby release the awl handle <NUM> from its engagement with the proximal handle <NUM> of the driver <NUM> as discussed above. For example, the tabs <NUM> of the awl handle <NUM>, which act as stop surfaces, are disengaged from the openings <NUM> of the proximal handle <NUM>, which causes the awl handle <NUM> to move proximally, as shown by arrow <NUM> in <FIG>. The proximal awl shaft <NUM> coupled to the awl handle <NUM> thus moves proximally to become spaced apart from the distal awl shaft <NUM> (as shown, for example, in <FIG>). Once the proximal awl shaft <NUM> no longer abuts the distal awl shaft <NUM>, distal movement of the driver shaft <NUM> relative to the distal awl shaft <NUM> is no longer prevented. Also, because the proximal awl shaft <NUM> is moved proximally such that there is clearance between its distal end and the distal awl shaft, the proximal awl shaft <NUM> is thus positioned out of the way of the suture <NUM> so as to reduce the potential for suture entanglement during distal advancement of the driver <NUM>.

Once the system <NUM> is moved from the bone hole forming configuration to the suture anchor driving configuration, the suture anchor <NUM> can be driven into the bone hole <NUM>. Thus, the proximal handle <NUM> is rotated, as shown by arrow <NUM> in <FIG>, to cause the driver shaft <NUM> to rotate and to drive the suture anchor <NUM>, coupled to the distal driver member <NUM> of the driver shaft <NUM>, distally to the bone hole <NUM>. In the illustrated embodiments, as the suture anchor <NUM> is advanced distally, the proximal end 108p of the distal awl shaft <NUM> does not extend proximally beyond the distal end 136d of the suture retaining feature <NUM> (e.g., slot) of the driver shaft <NUM>.

In the illustrated embodiment, the awl handle <NUM> and the proximal handle <NUM> are shown (by arrows <NUM> and <NUM>, respectively) to be rotated in opposite directions by way of example. It should be appreciated that, in other implementations, a handle coupled to a proximal awl shaft and a handle coupled to a driver shaft of a driver can be configured to be rotated in the same direction.

As the suture anchor <NUM> is advanced into the hole <NUM> in the bone <NUM>, the threads <NUM> of the suture anchor <NUM> engage the bone <NUM>. As the driver <NUM> is rotated, the distal awl shaft <NUM>, which extends through the lumen <NUM> of the driver shaft <NUM> and through the dilator feature <NUM>, remains stationary. The rotation of the driver <NUM> causes the suture anchor <NUM> to move distally towards the distal dilator 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 driver <NUM>, as well as the distal awl shaft <NUM> seated therein, can be separated from the suture anchor <NUM>. 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>. As shown in <FIG>, after the suture anchor <NUM> has been driven distally towards the dilator feature <NUM> and into the bone, the suture <NUM> extends proximally through at least a portion of the lumen in the suture anchor <NUM>. If desired, the terminal end portions 240a, 240b of the suture <NUM> can be trimmed using a suitable cutting instrument, such as scissors <NUM>, as shown schematically in <FIG>. Also, in some embodiments, the terminal end portions 240a, 240b of the suture <NUM> can be passed through the tissue <NUM>, or the terminal end portions 240a, 240b can be coupled to another suture anchor, or tied to other sutures, as desired.

A system having distal and proximal awl shafts in accordance with the described techniques can have a variety of configurations. A proximal handle of the system's driver can also vary in many ways. <FIG> illustrate another embodiment of a system <NUM> which can have a distal awl shaft and a proximal awl shaft that can be moved proximally away from the distal awl shaft in an anchor insertion configuration of the system. The system <NUM> has a driver <NUM> having a proximal handle <NUM> and a driver shaft <NUM> extending distally from the handle <NUM>. The driver <NUM> can have a configuration similar to that of driver <NUM> (<FIG> and <FIG>) and is therefore not described in detail. Similarly, the system <NUM> can have a distal awl shaft (not shown) and a proximal awl shaft <NUM> that are similar to distal and proximal awl shafts <NUM>, <NUM> of <FIG> and are therefore not described in detail. In this embodiment, an awl handle <NUM> coupled proximally to the proximal awl shaft <NUM> can have a trigger feature configured to be activated to cause the proximal awl shaft <NUM> to be retracted proximally away from the distal awl shaft, as discussed in more detail below. The trigger feature can be coupled to the awl handle or the trigger feature can be a separate component configured to be activated to cause the awl handle to move proximally to thereby cause the proximal awl shaft to move proximally.

As shown in <FIG>, <FIG>, the proximal handle <NUM> of the system <NUM> has a lumen <NUM> extending therethrough. As shown in <FIG>, the lumen <NUM> has a closed end within the proximal handle <NUM> such that the lumen <NUM> has one distal opening. The lumen <NUM> of the proximal handle <NUM> is configured to receive therein the awl handle <NUM> having tabs <NUM>, a spring <NUM>, and a driver shaft holder <NUM>.

As shown in <FIG>, the proximal handle <NUM> also has a slot <NUM> in a side wall thereof that is configured to receive therethrough a trigger feature configured to activate the awl handle <NUM>, such as a sliding button <NUM>. The button <NUM> can be coupled to the awl handle <NUM> in any suitable manner. For example, the button <NUM> can be a separate component. The slot <NUM>, communicating with the lumen <NUM> of the proximal handle <NUM>, is configured to receive at least a portion of the sliding button <NUM>. In this embodiment, as shown in <FIG>, the button <NUM> can be a generally cylindrical member having an opening <NUM> therethrough. The opening <NUM> of the button <NUM> can receive a portion of the awl handle <NUM> therethrough, as shown in <FIG> discussed in more detail below. The awl handle <NUM> can be inserted through the opening <NUM> of the button <NUM> such that a portion of the button <NUM> protrudes beyond the surface of the proximal handle <NUM> and that portion of the button <NUM> can be activated (e.g., pushed towards the surface of the proximal handle <NUM>) to thereby move the button <NUM> deeper into the proximal handle <NUM>.

As shown in <FIG>, and <FIG>, the proximal handle <NUM> can have a surface feature <NUM> disposed approximately in the middle of the handle <NUM>. The slot <NUM> can be formed in relation to the feature <NUM> as shown in <FIG>, and, in this example, the slot <NUM> is approximately centered with, and wider than feature <NUM>.

The proximal handle <NUM> can have various configurations. In this embodiment, a proximal part 331p of the proximal handle <NUM> extending proximally from feature <NUM> is generally cylindrical, and a distal part 331d of the proximal handle <NUM> extending distally from feature <NUM> is generally conical (e.g., in the form of a truncated cone) and distally tapered. The proximal and distal parts 331p, 331d of the proximal handle <NUM> can have surface features, such as plates or ribs <NUM> extending along a length of the proximal and distal parts 331p, 331d, as shown in <FIG>. The ribs <NUM> can have the same width, or, as in this example, some of the ribs <NUM>, such as one or more ribs 333a extending along one or both sides of the proximal handle <NUM>, can be wider (e.g., for reinforcement purposes). It should be appreciated that the specific shape and features of the proximal handle <NUM> are shown by way of example only, as the proximal handle of the driver of the system having a button-activated awl handle can have any suitable configuration, and may or may not have surface features.

The awl handle <NUM> can also have various configurations. In this embodiment, as shown in <FIG>, the awl handle <NUM> is generally cylindrical, with the tabs <NUM> extending from opposed sides of an outer wall thereof. As shown in <FIG>, the awl handle <NUM> has a circumferential lumen <NUM> formed from its distal end 320d through at least a portion of the awl handle <NUM>. The circumferential lumen <NUM> is formed such that the lumen <NUM> is formed around a solid internal portion <NUM> of the awl handle <NUM>. The circumferential lumen <NUM> is configured to receive a spring <NUM>, shown in <FIG> (not shown in <FIG>, although present), and the solid internal portion <NUM> has a lumen <NUM> configured to receive therein the proximal awl shaft <NUM>. In the illustrated embodiment, the distal end of the internal portion <NUM> can be in the form of a mating feature, such as a female mating feature, although other forms of a mating feature can be used.

A lumen <NUM> of the driver shaft <NUM> receives the proximal awl shaft <NUM> therethrough, the proximal awl shaft <NUM> being coupled to the awl handle <NUM>. As shown in <FIG>, the driver shaft holder <NUM> has a lumen <NUM> that is configured to receive a proximal end 306p of the driver shaft <NUM> such that at least a portion of the driver shaft <NUM> is coupled thereto. The lumen <NUM> extends between a distal-facing surface 321d and the proximal-facing surface 321p of the driver shaft holder <NUM>. As shown in <FIG>, the driver shaft holder <NUM> is configured to mate with a corresponding female mating feature at the distal end of the lumen <NUM> of the handle <NUM>.

The system <NUM> can be used in a surgical procedure similar to the way in which system <NUM> is used, as shown in <FIG>. In a bone hole forming configuration of the system <NUM>, the sliding button <NUM> is configured to protrude beyond the outer wall of the proximal handle <NUM>, as shown in <FIG>. In such a configuration, as shown in <FIG>, the tabs <NUM> of the awl handle <NUM> abut the sliding button <NUM> distally such that the awl handle <NUM> is prevented from being moved proximally. The spring <NUM> (not shown in <FIG>) can be disposed within the circumferential lumen <NUM> of the awl handle <NUM> in at least partially compressed configuration.

To move the system <NUM> from the bone hole forming configuration to a suture anchor insertion configuration, the button <NUM> can be activated, such as pressed or pushed towards the outer surface of the proximal handle <NUM>, as shown in <FIG>. This causes the button <NUM> to be moved deeper into the slot <NUM> of the proximal handle <NUM> and thereby release the tabs <NUM> of the awl handle <NUM> from engagement with the button <NUM>. <FIG> shows that, for activation, the button <NUM> can be pushed until it is disposed substantially flush with the surface of the proximal handle <NUM>. However, in other implementations, the button <NUM> can be otherwise disposed after its activation.

<FIG> additionally illustrate the button <NUM> of the proximal handle <NUM>, while not all components are shown for ease of illustration purposes only. Thus, <FIG> shows the proximal handle <NUM> having the button <NUM> in the bone hole forming configuration of the system <NUM>, i.e. the button <NUM> is not activated, and the tabs <NUM> of the awl handle <NUM> are engaged with the button. <FIG> shows the proximal handle <NUM> with the button <NUM> in the suture anchor insertion configuration of the system, i.e. the button <NUM> is activated, such as depressed, and the tabs <NUM> of the awl handle <NUM> have been released from engagement with the button <NUM>.

As shown in <FIG>, the activation of the button <NUM> allows the awl handle <NUM> to move proximally within the proximal handle's lumen <NUM>, thus the proximal awl shaft <NUM>, coupled to the awl handle <NUM>, is also caused to move proximally. The spring <NUM> within the circumferential lumen <NUM> of the awl handle <NUM> can move from the least partially compressed configuration to a less compressed configuration and thereby biases the awl handle <NUM> proximally and maintains the awl handle <NUM> in such position. In this way, the proximal awl shaft <NUM> is spaced proximally apart from the distal awl shaft and the system's driver <NUM> can be used (e.g., by rotating the proximal handle <NUM>) to drive a suture anchor (not shown) into a bone hole. In this example, the awl handle <NUM> is moved proximally so as to abut a proximal end 318p of the proximal handle's lumen <NUM>. Thus, the lumen <NUM> of the proximal handle <NUM> can be configured such that the awl handle <NUM> is moved to a predetermined distance to thereby move the proximal awl shaft <NUM> proximally to that distance.

A surgical system can have any other configurations of a proximal handle and an awl handle. Also, the awl handle can have various trigger features configured to be activated to cause a proximal awl shaft coupled to the awl handle to move proximally. Also, the trigger feature can be configured such that the proximal awl shaft is retracted proximally, away from a distal awl shaft, without being rotated.

<FIG> illustrate another embodiment of a surgical system <NUM> having a driver device or driver <NUM> that includes a proximal handle <NUM> and a driver shaft <NUM>. Similar to system <NUM> (<FIG>), the system <NUM> includes a suture anchor <NUM> coupled to a distal driver member of the driver shaft <NUM>, a proximal awl shaft (not shown) having an awl handle <NUM> coupled proximally thereto, and a distal awl shaft <NUM> extending at least partially through the driver shaft <NUM>. As shown in <FIG>, also similar to system <NUM>, the system <NUM> can include a dilator feature <NUM> which is distal to the suture anchor <NUM> and has a distal portion of the distal awl shaft <NUM> at least partially extending therethrough such that at least a portion of a distal tip 408d of the distal awl <NUM> shaft extends distally from a distal end of the dilator feature <NUM>. The dilator feature <NUM> can be implantable.

The proximal handle <NUM> can receive in a lumen <NUM> thereof the awl handle <NUM> that includes a generally cylindrical body <NUM> and a button or knob <NUM> that extends from the outer surface of the body <NUM>, as shown in <FIG>, <FIG>. The lumen <NUM> of the proximal handle <NUM> communicates with a slot <NUM> formed in the outer wall of the proximal handle <NUM> along a portion of the length of the handle <NUM>. In this way, the awl handle <NUM> is movably (e.g., slidably) seated within the lumen <NUM> and the slot <NUM> such that the knob <NUM> thereof protrudes at least partially beyond the outer surface of the proximal handle <NUM>, as shown in <FIG>. The knob <NUM> is configured to be activated to move the awl handle <NUM> along the slot <NUM>. The distal end 404d of the proximal handle <NUM> receives therein a proximal portion of the driver shaft <NUM>.

The inner walls of the slot <NUM> and at least a portion of the lumen <NUM> of the proximal handle <NUM> can be configured to conform at least partially to the configuration of the awl handle <NUM>. For example, at least a portion of the lumen <NUM> is generally cylindrical to movably seat therein the body <NUM> of the awl handle <NUM>. Further, in the illustrated example, the inner side walls of the slot <NUM> can be configured to seat the knob <NUM> of the awl handle <NUM> that has corresponding surfaces <NUM> at opposed sides thereof. As shown in <FIG>, the knob <NUM> has a top surface <NUM> that can be substantially flat and that has the surfaces <NUM> on opposed sides thereof that are slanted towards each other and sit on top of the body <NUM> of the awl handle <NUM>. In this example, a bore in the knob <NUM> can be formed between the slanted surfaces <NUM>, though it should be appreciated that the knob <NUM> can have any other configurations. It should be appreciated that the awl handle <NUM>, including the knob <NUM> thereof, are shown by way of example only, and that the awl handle can have any suitable configurations and can have other trigger features configured to be grasped or otherwise activated to move the awl handle.

The system <NUM> can be used in a surgical procedure similar to the way in which system <NUM> is used, as shown in FIGS. In a bone hole forming configuration of the system <NUM>, the awl handle <NUM> is seated in the lumen <NUM> of the proximal handle <NUM> and in the slot <NUM> such that the knob <NUM> protrudes beyond the outer surface of the proximal handle <NUM>, as shown in <FIG>. In such a configuration, as in other embodiments described herein, a distal end of the proximal awl shaft abuts a proximal end of the distal awl shaft <NUM>.

Once the bone hole has been formed, to move the system <NUM> from the bone hole forming configuration to a suture anchor insertion configuration, the handle <NUM> can be activated - (e.g., pushing on the knob <NUM> to move the handle <NUM> toward the central axis of the driver), resulting in motion of the knob (and the attached proximal awl shaft) proximally relative to the rest of the driver <NUM> (as shown schematically by arrow <NUM> in <FIG>). In this way, the awl handle <NUM> moves proximally so as to abut distally the inner surface of a portion <NUM> of the proximal handle <NUM>, as shown in <FIG>. The portion <NUM> can have any suitable configuration. A spring <NUM> (<FIG>), which can be disposed in the lumen <NUM> of the proximal handle <NUM>, can move from at least partially compressed to a less compressed configuration to thereby bias the awl handle <NUM> proximally. Similar to spring <NUM> of system <NUM> shown in <FIG> and <FIG>, the spring <NUM> can be disposed, for example, in a circumferential lumen of the awl handle <NUM>. However, the spring <NUM> can otherwise be associated with the awl handle <NUM>. The proximal movement of the awl handle <NUM> causes the proximal awl shaft coupled thereto to also move proximally and thus become spaced apart from the distal awl shaft <NUM>. In this configuration, the driver <NUM> of the system <NUM> can be used (e.g., by rotating the proximal handle <NUM>) to drive the suture anchor <NUM> into the bone hole.

It should be appreciated that the proximal handle <NUM> can have various surface features. For example, similar to the proximal handle <NUM> (<FIG>, and <FIG>), the proximal handle <NUM> can have ribs. For example, in the illustrated embodiment, the proximal handle <NUM> can have ribs <NUM> formed along at least a portion of a length thereof. As shown in <FIG> and <FIG>, a portion of the proximal handle <NUM> adjacent to the distal end 404d of the handle <NUM> is free of the ribs. Also, similar to proximal handle <NUM>, the proximal handle <NUM> of <FIG> can include a feature <NUM> formed on the outer wall thereof around at least a portion of its circumference. The Feature <NUM> can be disposed between a substantially cylindrical proximal portion of the proximal handle <NUM> and a distally tapered distal portion of the proximal handle <NUM>. However, again, the proximal handle <NUM> can have any other suitable shapes, configurations, and features that facilitate grip and operation of the proximal handle <NUM>.

The methods and systems described herein can have different variations. For example, in each of the embodiments, 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. For example, in some embodiments, a surgical system can have at least one suture pre-loaded thereto such that the surgical system in the assembled configuration includes the suture. Furthermore, in some embodiments, the dilator feature may not be used. As another variation, another feature can be used to dilate a hole in bone.

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 (<NUM>) having a proximal handle (<NUM>) and a driver shaft (<NUM>) extending therefrom, the driver having a lumen (<NUM>) extending therethrough;
a distal awl shaft (<NUM>) and a proximal awl shaft (<NUM>) separate from the distal awl shaft and movable proximally with respect to the distal awl shaft, the distal and proximal awl shafts being receivable in the lumen of the driver such that a portion of the distal awl shaft extends distally from a distal end of the driver shaft and the proximal awl shaft is disposed proximally to the distal awl shaft, wherein a distal end (108d) of the distal awl shaft is configured to initiate a hole in bone; and characterized in that the system further comprises
a suture anchor (<NUM>) having a lumen (<NUM>) extending therethrough that removably receives the distal awl shaft, wherein a distal driver feature (<NUM>) of the driver shaft is operably coupled to the suture anchor.