Patent ID: 12232715

DETAILED DESCRIPTION FOR CARRYING OUT THE INVENTION

Generally stated, disclosed herein are devices, implants, instrumentation, systems and related methods for retaining or coupling soft tissue to bones. The systems, instruments and related methods may facilitate preparation of a bone to accept the devices, implants, and systems therein/therethrough, implantation/insertion of the devices, implants, and systems into the prepared bone, and/or selection of properly sized devices, implants, and systems for a particular bone.

In this detailed description and the following claims, the words proximal, distal, anterior or plantar, posterior or dorsal, medial, lateral, superior and inferior are defined by their standard usage for indicating a particular part or portion of a bone (or any other anatomical structure) or device/implant/system/instrument according to the relative disposition of the natural bone (or any other anatomical structure) or directional terms of reference. For example, “proximal” means the portion of a device/implant/system/instrument nearest the torso, while “distal” indicates the portion of the device or instrument farthest from the torso. As for directional terms, “anterior” is a direction towards the front side of the body, “posterior” means a direction towards the back side of the body, “medial” means towards the midline of the body, “lateral” is a direction towards the sides or away from the midline of the body, “superior” means a direction above and “inferior” means a direction below another object or structure. Further, specifically in regards to the foot and/or ankle, the term “dorsal” refers to the top of the foot and the term “plantar” refers the bottom of the foot.

In some embodiments, the soft tissue retention devices, implants, instrumentation, systems and related methods of the present disclosure may comprise, or include one or more component, portion, aspect, function or the like that is similar to, or the same as, that disclosed in International PCT Patent Appl. No. PCT/US2017/048780 (hereinafter the '780 application), filed on Aug. 26, 2017, and entitled Tendon Retention Device, U.S. patent application Ser. No. 15/687,450 (hereinafter the '450 application), filed on Aug. 26, 2017, entitled Tendon Retention Device, U.S. Provisional Patent Appl. No. 62/379,789 (hereinafter the '789 application), filed on Aug. 26, 2016, U.S. Provisional Patent Appl. No. 62/454,100 (hereinafter the '100 application), filed on Aug. Feb. 3, 2017, and/or U.S. Provisional Patent Appl. No. 62/500,574 (hereinafter the '574 application), filed on May 3, 2017, which are hereby expressly incorporated herein by reference in their entireties. In some embodiments, the soft tissue retention device instrumentation, systems and related methods of the present disclosure may be utilized to implant a soft tissue retention device of the '780 application, the '450 application, the '789 application, the '100 application and/or the '574 application to attach or fix soft tissue to a bone.

Approximating language, as used herein throughout disclosure, may be applied to modify any quantitative representation that could permissibly vary without resulting in a change in the basic function to which it is related. Accordingly, a value modified by a term or terms, such as “about” or “substantially,” is not limited to the precise value specified. For example, these terms can refer to less than or equal to ±5%, such as less than or equal to ±2%, such as less than or equal to ±1%, such as less than or equal to ±0.5%, such as less than or equal to ±0.2%, such as less than or equal to ±0.1%, such as less than or equal to ±0.05%. In some instances, the approximating language may correspond to the precision of an instrument for measuring the value.

Referring to the drawings, wherein like reference numerals are used to indicate like or analogous components throughout the several views, and with particular reference toFIGS.1-7, there is illustrated an exemplary embodiment of a soft tissue (such as, but not limited to, tendon or ligament) retention, coupling, fixation or securement device, implant or system10configured to couple, retain, fix, and/or secure soft tissue to an associated or desired bone (such as, but not limited to, a relatively small bone (e.g., a bone of the foot or hand)). In some embodiments, the soft tissue retention device10may be particularly configured and/or advantageous for retention of a flexor digitorum longus tendon and an associated bone, such as, but not limited to, the plantar aspect of a proximal phalangeal base (bone) particularly, but not necessarily, for the correction of a toe contracture. However, the soft tissue retention device10may be configured and/or effectively utilized to retain, couple or fix any soft tissue (e.g., a tendon, ligament or the like) to any bone (e.g., any relatively small bone, such as a phalange, metatarsal or metacarpal bone) of a patient (e.g., a human patient).

The soft tissue retention device10is preferably, but not necessarily, made of a biocompatible metal such as titanium, stainless steel, an alloy, or the like, or other biocompatible material such as plastic, ceramic or the like.

The soft tissue retention device (or system or implant)10may comprise a first component12and a second component14, the nomenclature first and second being arbitrary. The first component12, without being restrictive, may be configured as a soft tissue tack member, portion or component, while the second component14, without being restrictive, may be may be configured as bone anchor member, portion or component12. When implanted, the soft tissue tack member12and the bone anchor member14are configured to nest and removably or fixedly couple together. As explained further below, one of the soft tissue tack member12and the bone anchor member14may be configured as an externally threaded male portion, and the other of the soft tissue tack member12and the bone anchor member14may be configured as an internally threaded female portion (for threadably mating with the externally threaded male portion).

In some embodiments, the soft tissue retention device10may be a two-piece device comprised of only the soft tissue tack member12and the bone anchor member14. In some other embodiments, the soft tissue retention device10may comprise additional components over the soft tissue tack member12and the bone anchor member14. In some embodiments, the soft tissue tack member12may be a one-piece or integral (e.g., monolithic) component. In some other embodiments, the soft tissue tack member12may be comprised of two or more separate and distinct components. In some embodiments, the bone anchor member14may be a one-piece or integral (e.g., monolithic) component. In some other embodiments, the bone anchor member14may be comprised of two or more separate and distinct components.

As shown inFIGS.1-13, the soft tissue tack member12incudes a head or base portion16and a threaded shaft portion18extending from the head portion16. The shaft portion18may be externally threaded (i.e., configured as a male portion or component) as shown inFIGS.1-13, or alternatively the shaft portion18may be internally threaded (i.e., configured as a female portion or component) (not shown). The head portion16may be generally disc-shaped (i.e., substantially flat, thin and curricular shaped) (although other shapes may be used). As also shown inFIGS.1-13, the head portion16may have a generally planar outer or upper side, face or surface20and an inner or under side, face or surface22. The shaft portion18extends from a central or center portion of the inner side22of the head portion16. The shaft portion18may extend generally transverse from the inner side22of the head portion16. The shaft portion18may define a first diameter, and the head portion16may define a second diameter that is larger than the first diameter.

As shown inFIGS.2,4,7,9,11and13, the head portion16includes a drive or torque aperture, indentation, cavity or slot24in the outer side20thereof that is configured to mate with an instrument, tool or guide member for rotating (or preventing rotation), inserting or aiding in the insertion, guiding, installation or implantation of the soft tissue tack member12into/through soft tissue and a bone, as explained further below. The drive aperture24is of a non-circular cross-sectional shape so that that a torque device can mate therein and an apply a rotational force to the soft tissue tack member12.

As shown inFIGS.2-4,7-11and13, the head portion16and the shaft portion18may include a cannulated opening40extending therethrough about an axis (e.g., a longitudinal axis and/or an axis of rotation) of the tack member12. The tack member12, as a whole, may thereby be cannulated. The drive aperture24may be aligned with, or formed as part as, the outer portion of the cannulated opening40of the tack member12. If the shaft portion18is internally threaded as opposed to being externally threaded as shown inFIGS.1-13, the cannulated opening40thereof may include the internal threads.

As shown inFIGS.1,3,5-8,10,12and13, the inner side22of the head portion16may include an annular sloped (e.g., arcuately concave) or angled transition surface portion26that extends or transitions to/from the threaded shaft portion18. As shown inFIGS.1,2and4-13, the head portion16may include a plurality of through holes28extending therethrough that are circumferentially spaced about the periphery or outer sides of the drive aperture24and shaft portion18. The through holes28may extend from the (planar) outer side surface20of the head portion16to the outer peripheral portion of the transition portion26of the inner side22of the head portion16. The through holes28are configured to allow soft tissue to extend therein/therethrough when the soft tissue retention device10is tightened/compressed onto the soft tissue and adjacent bone to exsanguinate and securely grip/couple the soft tissue.

As shown inFIG.13, the inner side22of the head portion16may also include an annular arcuately concave groove or depression portion30that extends between an inner or back side of an outer peripheral row of teeth or projections32and the transition portion28. The annular depression30may be configured to contain or filled by the soft tissue when the soft tissue retention device10is tightened/compressed onto the soft tissue and adjacent bone. As also shown inFIG.13, the row of teeth32may define the outer periphery of the head portion16. In some embodiments, the inner side22of the head portion16may only comprise a single row of the teeth32at the periphery thereof. The inner or back side of the teeth32may be arcuate (e.g., arcuately concave) and/or planar. The outer side of the teeth32may planar and/or arcuate (e.g., arcuately convex or concave). The lateral sides of the teeth32(and the gullets extending therebetween) be arcuate (e.g., arcuately concave), and the teeth32may narrow as they extend longitudinally away from the inner side22of the head portion16, as shown inFIGS.1,2,5,6,8,9and12. In some other embodiments, the lateral sides of the teeth32be planar and/or arcuate. The tips of the teeth32may be linear/flat or planar. In some other embodiments, the tips of the teeth32may be arcuate. The teeth32may define an axis that is aligned with the axis of the tack member12. Stated differently, the teeth32may extend along a direction that is aligned or parallel to the axis of the tack member12in all directions (and thereby perpendicular or normal to the head portion16).

As explained above, the threaded shaft portion18of the soft tissue tack member12is configured to threadably couple with a corresponding or mating threaded shaft portion48of the bone anchor member14, as shown inFIGS.1-13. As shown inFIGS.1-7and14-18, the bone anchor member14includes a head or base portion46and the threaded shaft portion48extending from the head portion46. The shaft portion48may be internally threaded (i.e., configured as a tubular hollow female portion or component) as shown inFIGS.1-7and14-18, or alternatively the shaft portion48may be externally threaded (i.e., configured as a male portion or component) (not shown).

The head portion46may be generally disc-shaped (i.e., substantially flat, thin and curricular shaped) (although other shapes may be used). As also shown inFIGS.1-7and14-18, the head portion46may have a generally planar outer or upper side, face or surface50and an inner or under side, face or surface52. The shaft portion48extends from a central or center portion of the inner side52of the head portion46. The shaft portion48may extend generally transverse from the inner side52of the head portion46. The shaft portion48may define a first diameter, and the head portion46may define a second diameter that is larger than the first diameter.

As shown inFIGS.1,3,7,14and16, the head portion46of the bone anchor member14includes a drive or torque aperture, indentation, cavity or slot54in the outer side50thereof that is configured to mate with an instrument, tool or guide member for rotating (or preventing rotation), inserting or aiding in the insertion, guiding, installation or implantation of the bone anchor member14into/through a bone, as explained further below. The drive aperture54is of a non-circular cross-sectional shape so that that a torque device can mate therein and an apply a rotational force to the bone anchor member14.

As shown inFIGS.1,3,7and14-17, the head portion46and the shaft portion48may include a cannulated opening40extending therethrough about an axis (e.g., a longitudinal axis and/or an axis of rotation) of the bone anchor member14. The bone anchor member14, as a whole, may thereby be cannulated. The drive aperture54may be aligned with, or formed as part as, the outer portion of the cannulated opening40of the bone anchor member14. If the shaft portion48is externally threaded as opposed to being internally threaded as shown inFIGS.1-7and14-18, the cannulated opening40may be void of the threads.

As shown inFIGS.2,7,15and17, the inner side52of the head portion46may include an annular sloped (e.g., arcuately concave) or angled transition surface portion that extends or transitions to/from the threaded shaft portion48. As also shown inFIGS.2,7,15and17, the inner side52of the head portion46may also include an annular groove or depression portion60that extends between an inner or back side of an outer peripheral row of teeth or projections62and the transition portion. The annular depression60may include an annular planar or flat bottom surface, and arcuately concave side portions formed by the transition surface portion and the inner sides of peripheral teeth62. The annular depression60may be configured to contain or be filled by bone material when the retention device10is tightened/compressed onto the adjacent bone.

As also shown inFIGS.1,2,5-7,14,15,17and18, the peripheral row of teeth62may define the circular outer periphery of the head portion46. In some embodiments, the inner side52of the head portion46may only comprise a single row of the teeth62at the periphery thereof. The inner or back side of the teeth62may be arcuate (e.g., arcuately concave) and/or planar. The outer side of the teeth62may planar and/or arcuate (e.g., arcuately convex or concave). The teeth32may define an axis that is aligned with the axis of the bone anchor member14. Stated differently, the teeth32may extend along a direction that is aligned or parallel to the axis of the bone anchor member14(and thereby perpendicular or normal to the head portion46).

As also shown inFIGS.1,2,5,6,14and18, the peripheral row of teeth62may be angled laterally or annularly/circumferentially. The teeth62may be “aggressive” such that the teeth62(e.g., the front faces thereof) are oriented at an acute angle. The teeth62may be oriented (e.g., angled) annularly/circumferentially in a direction that opposes the direction of the thread of the shaft portion48. In this way, the teeth62may be configured to dig into bone and resist rotation of the bone anchor member14in a direction that would unscrew or threadably de-couple from the threaded shaft18of the tack member12(when coupled therewith and implanted/installed in/on a bone).

An exemplary soft tissue retention drill bit180as shown inFIG.25may be utilized to form a soft tissue retention aperture101in a bone100as shown inFIG.26. As shown inFIGS.25and26, the drill bit180may include an aperture or through hole cutting portion182configured to form the aperture or through hole101that extends through the bone100via rotation of the cutting portion182. As also shown inFIGS.25and26, the drill bit180may include a countersink portion184that is configured to form a countersink102in through hole101on the side of the bone100that opposes soft tissue104via rotation of the countersink portion184.

The cannulated opening40and drive aperture24of the soft tissue tack member12, and the cannulated opening40and drive aperture54of the bone anchor member14, may facilitate assembly and implantation of the soft tissue retention device10via instrumentation, as shown inFIGS.19-31. An exemplary tack member drive and guide instrument170configured to facilitate assembly and implantation of the soft tissue retention device10, and the selection of a properly sized bone anchor member14for a specific bone100, is shown inFIGS.19-21and29-31.

As shown inFIGS.19-21and29-31, the tack member drive and guide instrument170includes a guide and sizing wire, post, member or portion171extending from a drive or torque projection172at an end of a handle portion173. As shown inFIGS.19,20,29,30, the handle portion173of the instrument170includes an aperture, annulus, ring, loop, band, or the like that allows a user to hold and manipulate the installation instrument170, potentially with one hand. For example, the aperture of the instrument170may be configured (e.g., sized and shaped) to allow a user to extend a digit therethrough, such as a user's thumb. In this way, a user can extend their thumb (for example) through the aperture of the instrument170and use at least a portion of the rest of their hand/fingers to engage the patient (e.g., engage a portion of the patient's foot or other body portion on an opposing side of the portion engaged (indirectly or directly) by the instrument170).

The guide and sizing wire171is configured to extend through the cannulated openings40of the soft tissue tack member12and the bone anchor member14(i.e., the cannulated opening40of the soft tissue retention device10). The guide and sizing wire171is of a fixed pre-determined length such that the free end or tip of the wire171is at a fixed pre-defined distance from the drive projection172. The drive projection172is configured to mate or extend within the drive aperture24of the soft tissue tack member12. As such, the drive projection172may be of the same non-circular cross-sectional shape and size as the drive aperture24of the soft tissue tack member12. The handle portion173may be fixed to the drive projection172such that torque/rotation (e.g., manual rotation) of the handle portion173rotates the drive projection172(or that prevention of rotation of the handle portion173prevents rotation of the drive projection172). In this way, as shown inFIGS.29-31, the tack member drive and guide instrument170may be manipulated such that the guide and sizing wire171is passed/positioned into and through the cannulated opening40of the soft tissue tack member12(from the head portion16thereof) and the drive projection172is positioned/mated within the drive aperture24. The handle portion173can then be utilized to support and manipulate the soft tissue tack member12to position the soft tissue tack member12through soft tissue and into the aperture101of the bone100with the guide wire portion171extending through the aperture101, and to ultimately rotate/apply torque to the soft tissue tack member12(or prevent rotation thereof), as shown inFIGS.29-31.

An exemplary bone anchor member drive and guide instrument175configured to facilitate assembly and implantation of the soft tissue retention device10is shown inFIGS.22-24,30and31. As shown inFIGS.22-24,30and31, the anchor member drive and guide instrument175includes a drive or torque projection176provided at an end of a handle portion178. As shown inFIGS.22-24, the anchor member drive and guide instrument175also includes a cavity or opening177extending from and into the drive projection176that is configured to accept or house the guide and sizing wire171of the tack member drive and guide instrument170therein. In this way, the cavity177of the anchor member drive and guide instrument175is configured to allow the guide and sizing wire171of the tack member drive and guide instrument170to extend therein.

The drive projection176is configured to mate or extend within the drive aperture54of the bone anchor member14. As such, the drive projection176may be of the same non-circular cross-sectional shape and size as the drive aperture54of the bone anchor member14. The handle portion178may be fixed to the drive projection176such that torque/rotation (e.g., manual rotation) of the handle portion178rotates the drive projection176(or that prevention of rotation of the handle portion178prevents rotation of the drive projection176). In this way, as shown inFIGS.30and31, the bone anchor member drive and guide instrument175(and the tack member drive and guide instrument170) may be manipulated such that the drive projection176is positioned/mated within the drive aperture54of the bone anchor member14. The handle portion178can then be utilized to support and manipulate the bone anchor member14to position the guide and sizing wire171of the tack member drive and guide instrument170into the cavity177of the bone anchor member drive and guide instrument175to align the soft tissue tack member12and the bone anchor member14(and align the bone anchor member14with the aperture101), position the bone anchor member14into the aperture101of the bone100, and to ultimately rotate/apply torque to the bone anchor member14(or prevent rotation thereof) to threadably couple the shaft portion18of the soft tissue tack member12and the shaft portion48of the bone anchor member14and compress the soft tissue retention device on the bone100, as shown inFIGS.30and31.

As noted above, the tack member drive and guide instrument170may be utilized to facilitate the selection/determination of a properly sized bone anchor member14for the specific bone100. As shown inFIGS.27-29, a bone anchor member sizing guide190may be configured to be utilized with the tack member drive and guide instrument170to facilitate the selection/determination of a properly sized bone anchor member14for the specific bone100. The bone anchor member sizing guide190may include an opening or through hole/aperture192at an end or tip of the bone anchor member sizing guide190that is configured to accept the wire portion171of the tack member drive and guide instrument170therein/therethrough (seeFIG.29). The bone anchor member sizing guide190may also include a groove, indentation and/or marking194that aligns with and accepts the portion of the wire portion171of the tack member drive and guide instrument170that passes through the opening192, as shown inFIG.29. As shown inFIG.29, the bone anchor member sizing guide190also includes a plurality of sizing markings196proximate to the groove194that correspond to differently sized bone anchor members14. For example, the plurality of sizing markings196of the bone anchor member sizing guide190may correspond to bone anchor members14with differing axial/longitudally sized shaft portions48(with the head portions46being of the same size or different sizes).

As shown inFIG.29, the bone anchor member sizing guide190may thereby be utilized to determine a properly sized bone anchor member14for a bone100which includes the soft tissue tack member12positioned in the through aperture101thereof (and through soft tissue) (such as on/in abutment with the countersink102in the bone100) via the tack member drive and guide instrument170. The tip or end of the bone anchor member sizing guide190may be positioned on/in abutment with the opposing side of the bone100as the soft tissue and soft tissue tack member12with the wire portion171of the tack member drive and guide instrument170extending through the opening192and along the groove194, as shown inFIG.29. The end of the wire portion171of the tack member drive and guide instrument170may substantially align (or most closely align) with one of the size indications196. The size indications196thereby indicate how thick the bone100is (or how thick/long the through aperture101is), and a correspondingly sized bone anchor member14that is configured to extend through the aperture101and to the soft tissue tack member12(to threadably mate with the soft tissue tack member12, as discussed above), as shown inFIGS.29-31.

As shown inFIGS.32-35, with a properly sized bone anchor member14selected/determined, the bone anchor member14may be threadably coupled to the soft tissue tack member12and the torqued/drawn together (via rotation) to compress the head portion16of the soft tissue tack member12against the soft tissue104(seeFIGS.34and35) and bone100and the head portion46of the bone anchor member14against the bone100. As noted above, the teeth32of the head portion16of the soft tissue tack member12may engage (and potentially penetrate into) the soft tissue104(and potentially the bone100) to retain the soft tissue104(seeFIGS.34and35), and the teeth62of the bone anchor member14may engage (and potentially penetrate into) the bone100, when the bone anchor member14and the soft tissue tack member12are torqued/drawn together as shown inFIGS.32-35. As also discussed above, the through holes28in the head portion16of the soft tissue tack member12may allow the soft tissue104(seeFIGS.34and35) to extend therein to securely retain the soft tissue104when the bone anchor member14and the soft tissue tack member12are torqued/drawn together, as shown inFIGS.32-35.

Another exemplary drive and guide instrument205configured to facilitate assembly and implantation of a soft tissue retention device is shown inFIGS.36-42. The instrument205is configured for installing or implanting a soft tissue retention device into soft tissue (e.g., a tendon or ligament) and bone, such as into at least one tendon and a bone of the extremities during a tendon to bone attachment procedure. The installation instrument (instrument)205is depicted in inFIGS.36-42and described herein in conjunction with the attachment of a flexor digitorum longus tendon and an associated bone, such as, but not limited to, the plantar aspect of a proximal phalangeal base (bone). However, it is noted that the instrument205may be utilized with other soft tissue (e.g., ligament or tendon) and bones (i.e., other soft tissue-to-bone attachment procedures). In some embodiments, the instrument205is made from one or more suitable surgical grade materials such as, but not limited to, stainless steel. Scaled instruments, for scaled soft tissue retention devices/implants (or portions or members thereof) and/or patient for example, are contemplated. Such scaled instruments and scaled soft tissue retention devices/implants (or portions or members thereof) may form at least part of an installation/implantation set or kit (not shown).

The drive and guide instrument205may be particularly advantageous in facilitating assembly and implantation of a non-cannulated or partially-cannulated soft tissue retention device, such as a partially-cannulated soft tissue retention device disclosed in the '780 application, the '450 application, the '789 application, the '100 application and/or the '574 application. In some such embodiments, the drive and guide instrument205may be configured to facilitate assembly and implantation of a soft tissue retention device that includes a cannulated soft tissue tack member or portion and a non-cannulated or partially-cannulated bone anchor member or portion. However, the drive and guide instrument205may be configured to facilitate assembly and implantation of a fully cannulated soft tissue retention device10ofFIGS.1-7, such as the fully cannulated soft tissue retention device10ofFIGS.1-7for example.

As shown inFIGS.36-42, the instrument205includes a handle section206configured to allow a user to hold and manipulate the installation instrument205with one hand, a gauging portion208extending from one side of the handle section206, and an insertion and fixation portion210extending from another side of the handle section206. The gauging portion208is configured to aid in determining (e.g., gauging) the size of a soft tissue retention device/implant to use with a particular soft tissue and bone complex. The insertion and fixation portion210is configured to temporarily hold at least a portion of the retention implant during the insertion and attachment procedure. The handle section206may also include more implements for more functions extending therefrom.

The installation instrument205allows for one-handed fixation and compression of the retention implant. As shown inFIGS.36-42, the handle section206comprises an aperture, annulus, ring, loop, band, or the like212configured (e.g., sized and shaped) to allow a user to extend a digit therethrough, such as a user's thumb. In this way, a user can extend their thumb (for example) through the aperture212and use at least a portion of the rest of their hand/fingers to engage the patient (e.g., engage a portion of the patient's foot or other body portion on an opposing side of the portion engaged (indirectly or directly) by the instrument205), as explained further below and shown inFIG.42.

As shown inFIGS.37and38, the gauging portion208includes a base portion215that extends radially from a neck portion218situated at one side of the handle section206. As also shown inFIGS.37and38, a rod portion214extends radially from the base portion215and defines a free end or tip224of the gauging portion208. When inserted into a through hole (e.g. drilled) of a bone, the rod portion214aids in gauging (e.g., visually determining) an implant size to use with the particular soft tissue and bone complex, while the base215provides a stop/seat surface to seat against or interface with the soft tissue and/or bone. In some embodiments, as shown inFIGS.36and37, the gauge rod portion214has a smooth outer texture. In one exemplary embodiment, the gauge rod portion214is cylindrical and includes a cross-sectional diameter of about 2 mm. However, other embodiments may include other configurations and/or sizes of the gauge rod portion214.

The insertion and fixation portion210comprises a head portion216extending radially from another neck portion219situated at another side of the handle portion206, as shown inFIGS.36-42. In some embodiments, the neck portion219and the head portion216are arranged about 180° from the neck portion218, base portion215and gauge rod214. However, the instrument215may include other arrangements/orientations thereof. As shown inFIGS.36and39-42, the head portion216includes a drive projection or tip217configured to temporarily engage a threaded and/or non-circular drive aperture of the implant, such as a soft tissue retaining portion or member thereof, for implantation and fixation (e.g., via application of a torque) of the implant. In one embodiment, the tip217and the aperture of the implant (e.g., the soft tissue retaining member) are threaded for threaded engagement therebetween (e.g., with a M1.25-0.3 thread). Other threads and/or connection configurations between the tip217and the aperture of the implant (e.g., the soft tissue retaining member) may be employed. The head portion216also provides another stop/seat surface to seat against or interface with the implant (e.g., the soft tissue retaining member thereof) and/or soft tissue and/or bone. When received on a user's digit (e.g., thumb as shown inFIG.42), the handle portion206of the instrument205can easily rotate about the thumb for easy manual manipulation of the instrument205and selective usage of the gauge rod214or the tip217.

FIGS.37-42illustrate an exemplary assembly and soft tissue retention device implantation procedure to fixedly attach, couple or retain soft tissue to a bone via a soft tissue retention device. By way of example,FIGS.37-42illustrate a method of use of the instrument205with respect to a non-cannulated (or partially-cannulated) soft tissue retention device and the attachment of a flexor digitorum longus tendon204to a plantar aspect of a proximal phalangeal base (bone)200. However, use of the instrument205is applicable to other soft tissue (e.g., tendon or ligament) to bone attachment procedures, as well as other surgical procedures. The non- or partially-cannulated soft tissue retention device may comprise a soft tissue retention device disclosed in the '780 application, the '450 application, the '789 application, the '100 application and/or the '574 application. The exemplary assembly and soft tissue retention device implantation procedure may equally or similarly be employed to a fully cannulated soft tissue retention device, such as the soft tissue retention device10ofFIGS.1-7described above.

FIG.42illustrates an exemplary manner of holding the instrument205during the procedure by placing one's thumb into/through the aperture212of the handle portion206. Rotation of the instrument205about the user's thumb thereby allows one handed fixation and compression of the soft tissue retention implant.

Generally, as shown inFIGS.37-42, the instrument205and the soft tissue retention implant can be utilized to affix, fix, secure, or otherwise hold soft tissue204(such as, but not limited to, a tendon) onto bone200. In preparation of securing the soft tissue204to the bone200via the soft tissue retention implant, an aperture may be made in the soft tissue (e.g., pierced by a scalpel or other instrument) and a through hole or bore201formed (e.g., drilled) in the bone200. A first member/portion of the soft tissue retention implant may be engaged with the head portion216of the instrument205. A portion of the first member/portion may be translated through the aperture in the soft tissue204and into the bone through hole201, and the soft tissue204appropriately tensioned (if desired). The first member/portion of the soft tissue retention implant may be compressed/forced against the soft tissue204to retain the relative position/orientation of the soft tissue204and the bone200, such as via the instrument205and the user's hand (potentially the same hand that engages the instrument205). A second member/portion of the soft tissue retention implant may be positioned within the bone through hole201from an opposing side thereof as compared to the first member/portion, and engaged with a torque tool. The second member/portion may be rotated with the torque tool, and the first member/portion prevented from rotating via the instrument205, to threadably couple the first and second members/portions and fixedly retain the soft tissue204to the bone200.

FIG.37illustrates determining a size of a soft tissue retention implant size (e.g., size of the soft tissue anchor member and/or size of the bone anchor member thereof) to use with the particular soft tissue/tendon204and bone200, which may comprise gauging the height or thickness of the combined bone200and tendon204. As shown inFIG.37, after a through hole201has been formed (e.g., drilled) through the bone200, the gauge rod portion214may be manually inserted through the tendon204and the through hole201until the bone200engages or comes into contact with the base portion215of the instrument205, and the tendon204is slightly compressed. For example, the user may insert a digit (e.g., a thumb) through the aperture212of the handle portion206and wrap one or more other finger on the opposing side of the bone (e.g., the dorsal side).

As shown inFIG.38, with the gauge rod portion214extending through the tendon204and the through hole201, and the base portion215abutting, and potential compressing, the tendon204and/or bone200, a gauge220may be received onto the exposed portion of the gauge rod portion214. A lower sleeve portion221of the gauge220may include an aperture of the like such that the lower sleeve portion221is received over the rod portion214and contacts a top or opposing side or surface of the bone200, as shown inFIG.38. As also shown inFIG.38, the gauge220may include a recess, opening or surface area223along within the rod portion214of the gauge220extends. The area223may include a plurality of visual and/or tactile indications222that form a size chart or otherwise indicate differing sized soft tissue retention devices/implants (or a component thereof). The position of the gauge rod tip224relative to the markings222of the gauge220(e.g., the marking222positioned closest to the tip224) can thereby be utilized by the user to indicate the size of the tissue retention device/implant that corresponds to the size of the patient's bone200and/or tendon204.

With the size of the soft tissue retention device/implant determined/gauged, the instrument205may then be utilized to install/implant the soft tissue retention device/implant by rotating the instrument205about the user's digit/finger (e.g., thumb) and removably coupled the drive tip217with a drive aperture or opening of a soft tissue retention tack member or portion230of the soft tissue retention device/implant. For example, the tip217may be threadably coupled with the drive aperture/opening of the soft tissue retention tack member230. As shown inFIG.39, the instrument205may then be utilized to insert the soft tissue retention tack member or portion230into the through hole201of the bone200and against the soft tissue/tendon204. Thereafter, with the soft tissue retention tack member230removably coupled with the drive tip217of the head portion216of the instrument205, a threaded stem portion232of the soft tissue retention tack member230may be held or maintained within the through hole201of the bone200(and/or a head portion of the soft tissue retention tack member230engaged/in abutment against the soft tissue/tendon204) via one handed manipulation of the instrument205by the user (e.g., via a user's digit/finger (e.g., a thumb) extending through the aperture212of the handle portion206of the instrument205).

With the soft tissue retention tack member230extending within the through hole201of the bone200and/or against the soft tissue/tendon204, the soft tissue/tendon204may be compressed against the bone200, as shown inFIG.40. In some embodiments, the bone200and soft tissue/tendon204may be relatively arranged into a particular anatomical arrangement/configuration, and the instrument205used to force the soft tissue retention tack member230against the soft tissue/tendon204, and thereby compress the soft tissue/tendon204between the soft tissue retention tack member230and the bone200. For example, in some embodiments, the user may manually straighten the toe bone200of the patient's foot, and then force the soft tissue retention tack member230against the tendon204, and thereby compress the tendon204between the soft tissue retention tack member230and the bone200, to maintain the relative orientation of the toe bone200(after letting go of the toe bone200), as shown inFIGS.40and42. In such a configuration, the tendon204can be held in its desired location by compression of the instrument205via the user's hand and the hand of the user that engages the instrument205being wrapped around the patient's foot/toe bone200(i.e., a one-handed technique or method). Alternatively, the tendon204can be held in its desired location by compression of the instrument205via a user's hand and the other hand of the user engaging/forcing an opposing side of the patient's foot/toe bone200(i.e., a two-handed technique or method), as shown inFIG.42.

FIG.41shows the compression of the soft tissue/tendon204against the bone200maintained by the user via the instrument205and the soft tissue retention tack member230, a bone anchor member or portion233of the soft tissue retention device/implant may be positioned into the bone through hole201from an opposing side thereof relative to the soft tissue/tendon204and soft tissue retention tack member230. As shown inFIG.41, a threaded stem portion234of the bone anchor member233may be positioned within the through hole201of the bone200, and a torque device or tool250may be engaged with a drive aperture or opening of a head portion235of the bone anchor member233. The bone anchor member233may be rotated/torqued via the torque device250such that the threaded stem portion234of the bone anchor member233threadably engages, mates or couples with the threaded stem portion232of the soft tissue retention tack member230within the through hole201of the bone200. Rotation of the soft tissue retention tack member230may be manually prevented (e.g., torque applied thereto) by the user via the engagement of the drive tip231of the instrument205with the drive aperture/opening of the head portion of the soft tissue retention tack member. Rotation of the bone anchor member233can thereby provide compression onto the soft tissue retention tack member to compress/force the soft tissue/tendon204onto the bone200.

As may be recognized by those of ordinary skill in the art based on the teachings herein, numerous changes and modifications may be made to the above-described and other embodiments of the present disclosure without departing from the scope of the disclosure. The components of the instruments, guides, systems and related methods as disclosed in the specification, including the accompanying abstract and drawings, may be replaced by alternative component(s) or feature(s), such as those disclosed in another embodiment, which serve the same, equivalent or similar purpose as known by those skilled in the art to achieve the same, equivalent or similar results by such alternative component(s) or feature(s) to provide a similar function for the intended purpose. In addition, the instruments, guides, systems and related methods (and components thereof) may include more or fewer components or features than the embodiments as described and illustrated herein. Accordingly, this detailed description of the currently-preferred embodiments is to be taken in an illustrative, as opposed to limiting of the disclosure.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has”, and “having”), “include” (and any form of include, such as “includes” and “including”), and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises,” “has,” “includes,” or “contains” one or more steps or elements possesses those one or more steps or elements, but is not limited to possessing only those one or more steps or elements. Likewise, a step of a method or an element of a device that “comprises,” “has,” “includes,” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.

The disclosure has been described with reference to the preferred embodiments. It will be understood that the architectural and operational embodiments described herein are exemplary of a plurality of possible arrangements to provide the same general features, characteristics, and general system operation. Modifications and alterations will occur to others upon a reading and understanding of the preceding detailed description. It is intended that the disclosure be construed as including all such modifications and alterations.