Patent ID: 12226092

DETAILED DESCRIPTION

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 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.

FIGS.1-11and12A-12Dillustrate one embodiment of a surgical system100that includes a driver device or driver102having a proximal handle104and a driver shaft106extending therefrom, a distal awl shaft108, a proximal awl shaft110that is separate from the distal awl108, a suture anchor112, and a dilator feature114that can be implantable. The system100also includes an awl handle120coupled to the proximal awl shaft110and extending at least partially proximally from the proximal handle104, as shown inFIG.1. The driver shaft106can have a lumen116extending longitudinally therethrough, as shown inFIG.5. The lumen116of the driver shaft106is configured to receive at least partially therethrough the distal awl shaft108such that a portion of the distal awl shaft108extends distally from a distal end of the driver shaft106and the proximal awl shaft110is disposed within the lumen116proximal to the distal awl shaft108, as also shown inFIG.5.

The proximal handle104has a lumen118extending along a length thereof and communicating with the lumen116of the driver shaft106. The lumen116of the driver shaft106and the lumen118of the proximal handle104provide a lumen that is configured to receive the proximal awl shaft110therethrough, as shown inFIGS.1,4,6A, and6B. A proximal end110pof the proximal awl shaft110can protrude proximally from the proximal end of the awl handle120. However, in other embodiments, the proximal end110pmay not protrude from the proximal end of the awl handle120. As shown inFIG.1, the surgical system100has a suture holding feature109coupled to an outer wall of the driver shaft106.

The suture anchor112, which can have external threads115formed thereon, has a lumen113extending therethrough that removably receives the distal awl shaft108. A distal driver feature of the driver shaft106is operably coupled to the suture anchor, as discussed in more detail below. The dilator feature114, which is distal to the suture anchor112, has a distal portion of the distal awl shaft108at least partially extending therethrough such that at least a portion of a distal tip108dof the distal awl108shaft extends distally from a distal end114dof the dilator feature114, as shown, for example, inFIGS.1,4and5. It should be appreciated that a dilator feature may not be present in some implementations.

As shown inFIG.4, the proximal awl shaft110has the awl handle120coupled to a proximal portion thereof such as, for example, the portion of the proximal awl shaft110extends through a bore in the awl handle120. The proximal awl shaft110is non-movably coupled to the awl handle120that is configured to be activated to cause the proximal awl shaft110to be retracted proximally away from the distal awl shaft108. In the illustrated embodiment, the awl handle120is disposed at least partially within the proximal handle104of the driver102, and the awl handle120and the proximal handle104of the driver102can be independently movable, as discussed in more detail below. The proximal awl shaft110can be coupled to the awl handle120in many various ways, for example, by press-fit, by adhesive, glue, by ultrasonic welding, etc.

The components of the system100can have various configurations. Thus, the distal and proximal awl shafts108,110can have many variations. As shown inFIGS.2,4, and5, the distal awl shaft108is a generally cylindrical elongate member having a central portion122and a distal portion124extending distally from the central portion122. At least a portion of the distal awl shaft108can have a suture retaining feature126extending longitudinally through a sidewall thereof. For example, in the illustrated embodiment, the suture retaining feature126extends from (and through) a portion of a proximal end124pof the distal portion124to a proximal end122pof the central portion122, which coincides with a proximal end108pof the distal awl shaft108. As shown inFIG.2, the suture retaining feature126has a proximal opening at the proximal end108pof the distal awl shaft108. As also shown inFIG.2, in the illustrated embodiment, a distal end126dof the suture retaining feature126is disposed just distal to the proximal end124pof the distal awl shaft's distal portion124.

In some embodiments, the proximal end of the distal awl shaft108can have a larger diameter than a distal end of the proximal awl shaft110. In the illustrated embodiment, the proximal end108pof the distal awl shaft108includes a mating feature128having 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 inFIG.2, the diameter of the mating feature128is greater than the diameter of the rest of the central portion122of the distal awl shaft108. As also shown inFIG.2, the distal portion124of the distal awl shaft108has a diameter that is less than the diameter of the central portion122.

As shown inFIGS.3-5, the proximal awl shaft110can be a generally cylindrical elongate member. The proximal awl shaft110extends through the lumen116of the driver102such that a proximal end110pthe proximal awl shaft110extends from a proximal end120pof the awl handle120. The system100is 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 inFIGS.4and5, a distal end110dof the proximal awl shaft110abuts the proximal end108pof the distal awl shaft108in a configuration in which the system100is used to form a hole in a bone. The system100can be configured such that, in the bone hole forming configuration, the proximal awl shaft110is biased against the distal awl shaft108such that the driver shaft106is prevented from being moved distally relative to the distal awl shaft108.

When load is applied to the proximal awl shaft110during initiation of the hole, the proximal awl shaft110applies load to the distal awl shaft108the distal end108dof which is inserted into the bone. Thus, the distal and proximal awl shafts108,110act together to allow the system100to 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 end108dof the distal awl shaft108can be driven further distally into the hole by further applying load to the proximal awl shaft110. The dilator feature114, 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 shaft110is retracted proximally from the distal awl shaft108, for example, by activating the awl handle120coupled to the proximal awl shaft110as shown inFIGS.6A and6Bwhich are discussed in more detail below. The distal end108dof the distal awl shaft108remains in the bone hole and the suture anchor112can be driven over the distal awl shaft108without being hindered by the proximal awl shaft110. Also, moving the proximal awl shaft110such that its distal end110dis spaced apart from the proximal end108pof the distal awl shaft108allows the proximal awl shaft110to be out of the way of the suture when the suture anchor112, 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 driver102that is configured to drive the suture anchor112into bone can have various configurations. The driver shaft106can be coupled to the proximal handle104in various ways. As shown inFIG.7, the driver shaft106has a central portion107having a shoulder130at a distal surface thereof. The shoulder130is proximal to a distal driver member132that extends from the shoulder130to a distal end132dof the distal driver member132. The distal end132dis also a distal end106dof the driver shaft106of the driver102. The distal driver member132has the suture anchor112mounted thereon. In the illustrated embodiment, the driver shaft106has a neck feature131disposed between the shoulder130and the distal driver member132such that the neck feature131abuts a proximal end112pof the suture anchor112. In use, the neck feature131facilitates driving the suture anchor112distally. It should be appreciated that the driver shaft106can have other suitable configurations, including the configurations in which the shoulder130and/or the neck feature131are not included.

The lumen116of the driver shaft106receives the distal awl shaft108such that a proximal portion of the distal awl shaft108is seated within the lumen116. For example, as shown inFIG.5, the distal awl shaft108is received within the driver shaft's lumen116such that the mating feature128of the distal awl shaft108is seated proximal to the distal driver feature132of the driver shaft106. A distal surface128dof the mating feature128abuts a proximal surface134pof an inner shoulder134disposed within the driver shaft's lumen116proximal to the shoulder130of the driver102.

Further, in the illustrated embodiment, the driver shaft106of the driver102has a suture retaining feature136extending longitudinally through a sidewall thereof. The suture retaining feature136, which can be in the form of a slot, communicates with the suture retaining feature126of the distal awl shaft108, as shown, for example, inFIG.5. In the illustrated embodiment, the suture retaining feature136of the driver shaft106can be in the form of a longitudinal slot that opens into the lumen116of the driver shaft106. As shown inFIG.7, the suture retaining feature136extends along the length of the driver shaft106between its distal and proximal ends136d,136p. In this example, the distal end136dof the suture retaining feature136is proximal to the shoulder130and the proximal end136pis distal to the proximal end106pof the driver shaft106. It should be appreciated that the suture retaining feature136can be formed in other ways in the driver shaft106.

As shown inFIG.5, a suture140(which can be in the form of two or more suture strands) can be passed as shown by arrow117—such that suture's terminal end portion142is passed through the suture retaining feature126of the distal awl shaft108, through the lumen113of the suture anchor112(which has the distal awl shaft108extending therethrough) and through at least a portion of the suture retaining feature136of the driver shaft106. The terminal end portion142of the suture140extends from the driver shaft106as shown inFIG.5. As also shown, the terminal end portion142extends from the driver shaft106proximally to the suture holding feature109coupled to the outer wall of the driver shaft106proximal to the distal end136dof the suture retaining feature136of the driver shaft106. The suture holding feature109which can, for example, extend at least partially radially about the outer wall of the driver shaft106, allows, in use, maintaining a position of the suture140while preventing suture wrapping within the driver shaft106. Also, in an arthroscopic procedure, the suture holding feature109facilitates directing the terminal end142of the suture140out of a cannula through which the system100(and other instruments) can be inserted to access a surgical site.

The suture holding feature109can have various configurations and it be coupled to the driver shaft106in a variety of ways. For example, the suture holding feature109can be in the form of a ring, or it can have a semi-circular shape. It can be non-movably attached to the driver shaft106. In some embodiments, however, the suture holding feature109can be movable with respect to the driver shaft106, though it is coupled to the driver shaft106such that its position with respect to the shaft106can be adjustable. For example, the suture holding feature109can be configured to be slidably attached to the driver shaft106, e.g., via friction fit or in other ways, such as a position of the suture holding feature109with respect to the driver shaft106can be adjusted and, once adjusted, maintained. The suture holding feature109can be attached to the driver shaft106removably or, in some implementations, it can be permanently fixed to the shaft driver shaft. In at least one embodiment, the suture holding feature109can have an opening on a side thereof such that the feature109can be snapped on or otherwise removably coupled to the driver shaft106.

The suture holding feature109can be coupled to the driver shaft106such that the suture holding feature109seats above a cannula which can be used in a surgical procedure. For example, in use, the system300can be inserted to a surgical site through the cannula, and the suture holding feature109can then be slidably or otherwise attached to the driver shaft106.

The suture anchor112can have various configurations. In the illustrated embodiment, as mentioned above, the suture anchor112has at least one external thread115formed thereon that is configured to engage the suture anchor112with the bone. However, the suture anchor112can 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 inFIG.9, the suture anchor112has the lumen113extending therethrough such that at least a portion of the lumen113can receive therein the distal driver member132. In an assembled configuration, as shown inFIGS.5and9, the distal driver member132extends through the lumen113of the suture anchor112such that the distal end132dof the distal driver member132is disposed proximal to a distal end112dof the suture anchor112. However, in other embodiments, the distal end132dof the distal driver member132can be aligned with or can extend beyond the distal end112dof the suture anchor112. As shown inFIG.9, the lumen113of the suture anchor112also receives therethrough the distal awl shaft108that extends through the distal driver member132.

The distal driver member132of the driver102is configured to releasably mate with the suture anchor112and to thereby drive the suture anchor112mated thereto distally into bone (over the distal awl shaft108), as discussed in more detail below. In some embodiments, as illustrated herein, the distal driver member132can 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 anchor112.

In the illustrated embodiment, as shown inFIG.9, the distal driver member132can be in the form of a male feature that is hexagonal-shaped, and the corresponding female drive feature of the suture anchor112can be a corresponding hexagonal-shaped female drive feature formed in at least a portion of an interior wall defining the lumen113of the suture anchor112.FIG.9shows that at least a portion of the interior wall defining the lumen113of the suture anchor112is hexagonal in cross-section. In the illustrated embodiment, a distal portion144(FIGS.5and8) of the interior wall defining the suture anchor's lumen113may be circular in cross-section such that it does not have the hexagonal feature. In this embodiment, the distal driver member132of the driver102extends through the lumen113of the suture anchor112such that the distal end132dof the distal driver member132is disposed proximal to the distal end112dof the suture anchor112. The distal portion144of the interior wall defining the lumen113of the suture anchor112is circular in cross-section, which facilitates passage of a suture through a distal end of the lumen113of the suture anchor112. The circular cross-sectional shape of the distal portion144of the lumen113also helps prevent suture tangling around the distal end of the suture anchor112.

In the illustrated embodiment, as shown inFIGS.1,4,5,6A,6B, and8, the surgical system100includes the dilator feature114that is distal to the suture anchor112. The distal awl shaft108is configured to extend through a lumen of the dilator feature114such that the distal end108dof the distal awl shaft108extends distally from the dilator feature114, as shown, for example, inFIG.8. The dilator feature114is configured to facilitate insertion of the distal awl shaft108into bone by widening a hole in bone once the hole is initiated, such as by the distal end108dof the distal awl shaft108. The dilator feature114can be distally tapered and it can be in the form of a truncated cone or pyramid. In the illustrated example, as shown inFIG.4, the dilator feature114can have a proximal neck portion146that has substantially the same diameter along its length, and a distal portion148that extends distally from the proximal neck portion146and that is distally tapered. An outer wall of the distal portion148of the dilator feature114can 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 feature114can have any suitable configurations.

The dilator feature114can be press-fit onto or otherwise releasably coupled with the distal awl shaft108and it can have any suitable dimensions. Furthermore, in some embodiments, the dilator feature114can 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 system100. Moreover, while it is sufficiently rigid to assist in forming a bone hole, the dilator feature114can be bioabsorbable and/or biodegradable. However, in other embodiments, the dilator feature114can be made from a metal.

The proximal handle104of the driver102can have a variety of configurations. In the illustrated embodiment, as shown inFIGS.4and6B, the lumen118of the proximal handle104receives a proximal portion of the driver shaft106such that the lumen118communicates with the lumen116of the driver shaft106. In this way, the lumens116and118receive the proximal awl shaft110therethrough. The driver shaft106is coupled to the proximal handle104in any suitable manner, such that rotation of the proximal handle104causes the driver shaft106to be rotated. The proximal handle104of the driver102can be configured to have surface features that facilitate grip during use of the system100. For example, as shown inFIG.10, the proximal handle104has one or more grooves145formed along its length. It should be appreciated, however, that the proximal handle104can have any suitable surface features, as the described embodiments are not limited in this respect.

The proximal handle104of the driver102can be coupled to the awl handle120, which is coupled to the proximal awl shaft110. For example, as shown inFIGS.4and6B, the lumen118of the proximal handle104is configured to receive the awl handle120at least partially therein. Thus, the lumen118of the proximal handle104has a distal portion148configured to receive the proximal portion of the driver shaft106, and a proximal portion150configured to receive at least part of the awl handle120therein. As shown inFIGS.4and6B, the proximal portion150of the proximal handle's lumen118can have a larger diameter than the distal portion148of the lumen118and the proximal portion150has a configuration corresponding to a configuration of the awl handle120. The proximal portion150of the lumen118communicates with openings105in the proximal handle104. As shown inFIGS.4and6B, the proximal portion150of the proximal handle's lumen118includes pins111or other features configured to retain a position of the awl handle120(e.g., its tabs158).

As shown inFIG.11, the awl handle120has a distal portion152, a central portion154, and a proximal portion156. The distal, central, and proximal portions152,154,156of the awl handle120are generally cylindrical, with the distal portion152having a diameter smaller than that of the central portion154, and the central portion154having a diameter smaller than a diameter of the proximal portion156. The distal and central portions152,154of the awl handle120are received in the proximal portion150of the lumen118of the proximal handle104, and the proximal portion156of the awl handle120protrudes beyond the proximal end104pof the proximal handle104, as shown inFIGS.4and6B. As also shown inFIGS.4and6A, the proximal portion150of the lumen118can be shaped similarly to the distal and central portions152,154of the awl handle120seated therein. Thus, in this example, the proximal portion150of the lumen118of the proximal handle104has a distal part having a diameter that is less than a diameter of a proximal part.

In the illustrated embodiment, the central portion154of the awl handle120has tabs158extending therefrom, as shown inFIGS.1,6B,10,11, and12A-12C. The tabs158can be in the form of ribs, wings, or they can be any other features. In the bone hole forming configuration of the system100, the tabs158of the of the awl handle120protrude from the slots105of the proximal handle104and thereby prevent the awl handle120(and thus the proximal awl shaft110coupled there) from moving with respect to the proximal handle104. In the illustrated embodiment, the proximal portion150of the lumen118of the proximal handle104includes a spring160(shown inFIG.11) configured to bias the awl handle120proximally when the awl handle120is released from engagement with the proximal handle104, such as the tabs158disengage from the openings105in the proximal handle as shown inFIG.6B. Thus, in the bone hole forming configuration of the system100, the spring160, which can extend along a length of the proximal portion150of the lumen118, can be in at least partially compressed configuration.

The proximal portion156of the awl handle120, which is positioned proximal to the proximal end104pof the proximal handle104, is configured to be grasped by a user (e.g., a surgeon) to cause the proximal awl shaft110to be retracted proximally. The proximal portion156can have any suitable surface features that facilitate gripping.

In use, in the configuration in which the system100is used to form a hole in bone, the proximal awl shaft110is disposed such that its distal end110dabuts the proximal end108pof the distal awl shaft108. In such a configuration, the driver102is prevented from being driven distally relative to the distal awl shaft, because of the engagement between the driver's proximal handle104and the awl handle120. To move the system100into the configuration in which it can be used to drive the suture anchor into the bone hole, the awl handle120can be activated. For example, in the illustrated example, the awl handle120can be rotated by grasping and rotating the proximal portion156to cause the tabs158of the awl handle120to rotate and enter the lumen118of the proximal handle104via the slots105. In this way, as shown inFIGS.6A and6B, once the tabs158no longer engage the slots105of the proximal handle104, the awl handle120, with assistance of the biasing spring160disposed in the proximal portion150lumen118of the proximal handle104, is caused to move proximally such that the central portion154of the awl handle120is protruded proximally beyond the proximal end104pof the proximal handle104.

As shown inFIG.6B, the tabs158of the awl handle120can abut distally the pins111in the proximal portion150of the proximal handle's lumen118, thereby the awl handle120is prevented from moving further proximally. In this way, the position of the pins111within the lumen118can determine a distance to which the awl handle120is 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 handle120is disengaged from the proximal handle104, the spring160can move from the at least partially compressed configuration to the less compressed configuration such that it helps bias the awl handle120proximally and to maintain the awl handle120in such position.

The proximal movement of the awl handle120causes the proximal awl shaft110, which is coupled thereto, to move proximally away from the distal awl shaft108. Thus,FIG.6Billustrates that the distal end110dof the proximal awl shaft110is spaced from the proximal end108pof the distal awl shaft108. It should be appreciated that, althoughFIG.6Bshows the distal end110dof the proximal awl shaft110disposed distal to the suture holding feature109, in some implementations, the proximal awl shaft110can be retracted proximally such that its distal end110dis disposed proximally to the suture holding feature109. Also, although not shown inFIGS.1,4,6A, and6B, in use, the system100has a suture coupled thereto, such as shown, for example, inFIG.5. After the proximal awl shaft110is retracted proximally, the proximal handle104can be rotated to drive the suture anchor112into the bone hole.

FIGS.12A-12Eillustrate a method of performing a surgical repair involving use of a surgical system, such as the surgical system100(shown by way of example only), to attach soft tissue202(e.g., tendon) to bone200. 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 system100.

FIG.12Aillustrates schematically (arrow205) that terminal end portions240a,240bof a suture240(which is similar to suture140ofFIG.5) are coupled to the system100which is in the bone hole forming configuration.FIG.12Aillustrates that the suture240can be coupled to the tissue202. For example, the suture240can be passed through or otherwise coupled to the tissue202such that the terminal end portions240a,240bof the suture240are free to engage with the system100. It should be appreciated that in some embodiments the suture240may be pre-loaded onto the system, or the suture240may be passed through or otherwise coupled to the tissue202after being anchored in the bone using the system100.

As discussed above in connection with suture140shown by way of example inFIG.5, the terminal end portions240a,240bof the suture240can be passed (arrow205) through the suture retaining feature126of the distal awl shaft108and through the lumen113of the suture anchor112, and along the suture retaining feature136of the driver shaft106. The terminal end portions240a,240bof the suture240are passed along a portion of the suture retaining feature136(e.g., slot) of the driver shaft106such that the terminal end portions240a,240bare passed under the suture holding feature109, as shown inFIG.12Billustrating the surgical system100with the suture240loaded thereon. In this way, the terminal end portions240a,240bof the suture240extend from the shaft106, as also shown inFIG.12B.

After the surgical system100with the suture240as shown inFIG.12B, the distal end108dof the distal awl shaft108is inserted into the bone200to initiate a hole in the bone200at a desired location, as shown inFIG.12C. Tension is applied to the suture240after the distal end108dof the distal awl shaft108is inserted into the bone200to form the hole201. In the illustrated embodiments, the distal awl shaft108, which has the proximal awl shaft110abutting 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 shaft108is driven further distally into the bone200to form a bole hole201. In particular, as shown inFIG.12Cby arrow207, a suitable instrument211, such as mallet, hammer, or other instrument, is used to apply force to the proximal end110pof the proximal awl shaft110that, in turn, applies load to the distal awl shaft108to thereby cause the distal awl shaft108to drive distally into the bone200. As the distal awl shaft108is driven distally into the bone200, the dilator feature114widens the hole201. Tension can be applied to the terminal end portions240a,240bof the suture240after the distal end108dof the distal awl shaft108is inserted into the bone200, as shown by arrow213inFIG.12C. The tensioning of the terminal suture portions240a,240ballows bringing the tissue202closer to the location of the bone hole201, as shown schematically inFIG.12Cwhere the tissue202is disposed closer to the bone hole201than inFIG.12Bin which the location of the bone hole201to be formed is shown.

The distal end108dof the distal awl shaft108is driven into bone200such that the dilator feature114coupled thereto is inserted into the hole201in the bone200, as shown inFIG.12C. A portion of the distal awl shaft108is also inserted into the hole201, whereas the suture anchor112is positioned at a desired position relative to the bone hole201. In the illustrated embodiment, as shown inFIG.12C, before being driven into the bone, the distal end of the suture anchor112is positioned at the proximal edge of the bone hole201. In other embodiments, the suture anchor112can be partially inserted into the bone hole.

Once the distal end108dof the distal awl shaft108with the dilator feature114is driven into the bone200to a desired depth, the proximal awl shaft110is moved proximally away from the distal awl shaft108. Accordingly,FIG.12Dshows that the awl handle120is actuated (i.e., rotated) grasping and rotating its proximal portion156(as shown by arrow215) to thereby release the awl handle120from its engagement with the proximal handle104of the driver102as discussed above. For example, the tabs158of the awl handle120, which act as stop surfaces, are disengaged from the openings105of the proximal handle104, which causes the awl handle120to move proximally, as shown by arrow217inFIG.12D. The proximal awl shaft110coupled to the awl handle120thus moves proximally to become spaced apart from the distal awl shaft108(as shown, for example, inFIG.6B). Once the proximal awl shaft110no longer abuts the distal awl shaft108, distal movement of the driver shaft106relative to the distal awl shaft108is no longer prevented. Also, because the proximal awl shaft110is moved proximally such that there is clearance between its distal end and the distal awl shaft, the proximal awl shaft110is thus positioned out of the way of the suture240so as to reduce the potential for suture entanglement during distal advancement of the driver102.

Once the system100is moved from the bone hole forming configuration to the suture anchor driving configuration, the suture anchor112can be driven into the bone hole201. Thus, the proximal handle104is rotated, as shown by arrow219inFIG.12D, to cause the driver shaft106to rotate and to drive the suture anchor112, coupled to the distal driver member132of the driver shaft106, distally to the bone hole201. In the illustrated embodiments, as the suture anchor112is advanced distally, the proximal end108pof the distal awl shaft108does not extend proximally beyond the distal end136dof the suture retaining feature136(e.g., slot) of the driver shaft106.

In the illustrated embodiment, the awl handle120and the proximal handle104are shown (by arrows215and219, 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 anchor112is advanced into the hole201in the bone200, the threads115of the suture anchor112engage the bone200. As the driver102is rotated, the distal awl shaft108, which extends through the lumen116of the driver shaft106and through the dilator feature114, remains stationary. The rotation of the driver102causes the suture anchor112to move distally towards the distal dilator feature114and into the bone200, which causes the suture240to be secured between an interior wall of the bone hole201and an outer surface of the suture anchor112.

Once the suture anchor112has been driven into the hole201in the bone200, the driver102, as well as the distal awl shaft108seated therein, can be separated from the suture anchor112. The dilator feature114and the suture anchor112with the suture240coupled thereto remain implanted in the bone hole201, thereby attaching the tissue202to the bone200, as shown inFIG.12E. As shown inFIG.12E, after the suture anchor112has been driven distally towards the dilator feature114and into the bone, the suture240extends proximally through at least a portion of the lumen in the suture anchor112. If desired, the terminal end portions240a,240bof the suture240can be trimmed using a suitable cutting instrument, such as scissors221, as shown schematically inFIG.12E. Also, in some embodiments, the terminal end portions240a,240bof the suture240can be passed through the tissue202, or the terminal end portions240a,240bcan 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.FIGS.13A-16Billustrate another embodiment of a system300which 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 system300has a driver302having a proximal handle304and a driver shaft306extending distally from the handle304. The driver302can have a configuration similar to that of driver102(FIGS.1and4-11) and is therefore not described in detail. Similarly, the system300can have a distal awl shaft (not shown) and a proximal awl shaft310that are similar to distal and proximal awl shafts108,110ofFIGS.2and3and are therefore not described in detail. In this embodiment, an awl handle320coupled proximally to the proximal awl shaft310can have a trigger feature configured to be activated to cause the proximal awl shaft310to 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 inFIGS.14,16A, and16B, the proximal handle304of the system300has a lumen318extending therethrough. As shown inFIGS.16A and16B, the lumen318has a closed end within the proximal handle304such that the lumen318has one distal opening. The lumen318of the proximal handle304is configured to receive therein the awl handle320having tabs327, a spring360, and a driver shaft holder321.

As shown inFIG.14, the proximal handle304also has a slot323in a side wall thereof that is configured to receive therethrough a trigger feature configured to activate the awl handle320, such as a sliding button325. The button325can be coupled to the awl handle320in any suitable manner. For example, the button325can be a separate component. The slot323, communicating with the lumen318of the proximal handle304, is configured to receive at least a portion of the sliding button325. In this embodiment, as shown inFIG.14, the button325can be a generally cylindrical member having an opening345therethrough. The opening345of the button325can receive a portion of the awl handle320therethrough, as shown inFIG.16Adiscussed in more detail below. The awl handle320can be inserted through the opening345of the button325such that a portion of the button325protrudes beyond the surface of the proximal handle304and that portion of the button325can be activated (e.g., pushed towards the surface of the proximal handle304) to thereby move the button325deeper into the proximal handle304.

As shown inFIGS.13A,13B, and14, the proximal handle304can have a surface feature329disposed approximately in the middle of the handle304. The slot323can be formed in relation to the feature329as shown inFIG.14, and, in this example, the slot323is approximately centered with, and wider than feature329.

The proximal handle304can have various configurations. In this embodiment, a proximal part331pof the proximal handle304extending proximally from feature329is generally cylindrical, and a distal part331dof the proximal handle304extending distally from feature329is generally conical (e.g., in the form of a truncated cone) and distally tapered. The proximal and distal parts331p,331dof the proximal handle304can have surface features, such as plates or ribs333extending along a length of the proximal and distal parts331p,331d, as shown inFIG.14. The ribs333can have the same width, or, as in this example, some of the ribs333, such as one or more ribs333aextending along one or both sides of the proximal handle304, can be wider (e.g., for reinforcement purposes). It should be appreciated that the specific shape and features of the proximal handle304are 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 handle320can also have various configurations. In this embodiment, as shown inFIG.14, the awl handle320is generally cylindrical, with the tabs327extending from opposed sides of an outer wall thereof. As shown inFIG.14, the awl handle320has a circumferential lumen335formed from its distal end320dthrough at least a portion of the awl handle320. The circumferential lumen335is formed such that the lumen335is formed around a solid internal portion337of the awl handle320. The circumferential lumen335is configured to receive a spring360, shown inFIG.16B(not shown inFIG.16A, although present), and the solid internal portion337has a lumen349configured to receive therein the proximal awl shaft310. In the illustrated embodiment, the distal end of the internal portion337can 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 lumen316of the driver shaft306receives the proximal awl shaft310therethrough, the proximal awl shaft310being coupled to the awl handle320. As shown inFIGS.14and15B, the driver shaft holder321has a lumen341that is configured to receive a proximal end306pof the driver shaft306such that at least a portion of the driver shaft306is coupled thereto. The lumen341extends between a distal-facing surface321dand the proximal-facing surface321pof the driver shaft holder321. As shown inFIGS.14and15A, the driver shaft holder321is configured to mate with a corresponding female mating feature at the distal end of the lumen318of the handle304.

The system300can be used in a surgical procedure similar to the way in which system100is used, as shown inFIGS.12A to12E. In a bone hole forming configuration of the system300, the sliding button325is configured to protrude beyond the outer wall of the proximal handle304, as shown inFIG.13A. In such a configuration, as shown inFIG.16A, the tabs327of the awl handle320abut the sliding button325distally such that the awl handle320is prevented from being moved proximally. The spring360(not shown inFIG.16A) can be disposed within the circumferential lumen335of the awl handle320in at least partially compressed configuration.

To move the system300from the bone hole forming configuration to a suture anchor insertion configuration, the button325can be activated, such as pressed or pushed towards the outer surface of the proximal handle304, as shown inFIG.13B. This causes the button325to be moved deeper into the slot323of the proximal handle304and thereby release the tabs327of the awl handle320from engagement with the button325.FIG.13Bshows that, for activation, the button325can be pushed until it is disposed substantially flush with the surface of the proximal handle304. However, in other implementations, the button325can be otherwise disposed after its activation.

FIGS.16C and16Dadditionally illustrate the button325of the proximal handle304, while not all components are shown for ease of illustration purposes only. Thus,FIG.16Cshows the proximal handle304having the button325in the bone hole forming configuration of the system300, i.e. the button325is not activated, and the tabs327of the awl handle320are engaged with the button.FIG.16Dshows the proximal handle304with the button325in the suture anchor insertion configuration of the system, i.e. the button325is activated, such as depressed, and the tabs327of the awl handle320have been released from engagement with the button325.

As shown inFIG.16B, the activation of the button325allows the awl handle320to move proximally within the proximal handle's lumen318, thus the proximal awl shaft310, coupled to the awl handle320, is also caused to move proximally. The spring360within the circumferential lumen335of the awl handle320can move from the least partially compressed configuration to a less compressed configuration and thereby biases the awl handle320proximally and maintains the awl handle320in such position. In this way, the proximal awl shaft310is spaced proximally apart from the distal awl shaft and the system's driver302can be used (e.g., by rotating the proximal handle304) to drive a suture anchor (not shown) into a bone hole. In this example, the awl handle320is moved proximally so as to abut a proximal end318pof the proximal handle's lumen318. Thus, the lumen318of the proximal handle304can be configured such that the awl handle320is moved to a predetermined distance to thereby move the proximal awl shaft310proximally 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.

FIGS.17-21Billustrate another embodiment of a surgical system400having a driver device or driver402that includes a proximal handle404and a driver shaft406. Similar to system100(FIG.1), the system400includes a suture anchor412coupled to a distal driver member of the driver shaft406, a proximal awl shaft (not shown) having an awl handle420coupled proximally thereto, and a distal awl shaft408extending at least partially through the driver shaft406. As shown inFIG.17, also similar to system100, the system400can include a dilator feature414which is distal to the suture anchor412and has a distal portion of the distal awl shaft408at least partially extending therethrough such that at least a portion of a distal tip408dof the distal awl408shaft extends distally from a distal end of the dilator feature414. The dilator feature414can be implantable.

The proximal handle404can receive in a lumen418thereof the awl handle420that includes a generally cylindrical body419and a button or knob425that extends from the outer surface of the body419, as shown inFIGS.17,18, and20. The lumen418of the proximal handle404communicates with a slot429formed in the outer wall of the proximal handle404along a portion of the length of the handle404. In this way, the awl handle420is movably (e.g., slidably) seated within the lumen418and the slot429such that the knob425thereof protrudes at least partially beyond the outer surface of the proximal handle404, as shown inFIG.17. The knob425is configured to be activated to move the awl handle420along the slot429. The distal end404dof the proximal handle404receives therein a proximal portion of the driver shaft106.

The inner walls of the slot429and at least a portion of the lumen418of the proximal handle404can be configured to conform at least partially to the configuration of the awl handle420. For example, at least a portion of the lumen418is generally cylindrical to movably seat therein the body419of the awl handle420. Further, in the illustrated example, the inner side walls of the slot429can be configured to seat the knob425of the awl handle420that has corresponding surfaces437at opposed sides thereof. As shown inFIG.20, the knob425has a top surface438that can be substantially flat and that has the surfaces427on opposed sides thereof that are slanted towards each other and sit on top of the body419of the awl handle420. In this example, a bore in the knob425can be formed between the slanted surfaces427, though it should be appreciated that the knob425can have any other configurations. It should be appreciated that the awl handle420, including the knob425thereof, 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 system400can be used in a surgical procedure similar to the way in which system100is used, as shown in FIGS.-12E. In a bone hole forming configuration of the system400, the awl handle420is seated in the lumen418of the proximal handle404and in the slot429such that the knob425protrudes beyond the outer surface of the proximal handle404, as shown inFIG.21A. 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 shaft408.

Once the bone hole has been formed, to move the system400from the bone hole forming configuration to a suture anchor insertion configuration, the handle420can be activated—(e.g., pushing on the knob425to move the handle420toward 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 driver402(as shown schematically by arrow435inFIG.21B). In this way, the awl handle420moves proximally so as to abut distally the inner surface of a portion431of the proximal handle404, as shown inFIG.21B. The portion431can have any suitable configuration. A spring460(FIG.19), which can be disposed in the lumen418of the proximal handle404, can move from at least partially compressed to a less compressed configuration to thereby bias the awl handle420proximally. Similar to spring360of system300shown inFIGS.14and16B, the spring460can be disposed, for example, in a circumferential lumen of the awl handle420. However, the spring460can otherwise be associated with the awl handle420. The proximal movement of the awl handle420causes the proximal awl shaft coupled thereto to also move proximally and thus become spaced apart from the distal awl shaft408. In this configuration, the driver402of the system400can be used (e.g., by rotating the proximal handle404) to drive the suture anchor412into the bone hole.

It should be appreciated that the proximal handle404can have various surface features. For example, similar to the proximal handle304(FIGS.13A,13B, and14), the proximal handle404can have ribs. For example, in the illustrated embodiment, the proximal handle404can have ribs433formed along at least a portion of a length thereof. As shown inFIGS.17and18, a portion of the proximal handle404adjacent to the distal end404dof the handle404is free of the ribs. Also, similar to proximal handle304, the proximal handle404ofFIG.17can include a feature439formed on the outer wall thereof around at least a portion of its circumference. The Feature439can be disposed between a substantially cylindrical proximal portion of the proximal handle404and a distally tapered distal portion of the proximal handle404. However, again, the proximal handle404can have any other suitable shapes, configurations, and features that facilitate grip and operation of the proximal handle404.

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. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

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).

One skilled in the art will appreciate further features and advantages of the described subject matter based on the above-described embodiments. Accordingly, the present disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.