Single-use plantar plate graft augmentation kit and method of repairing plantar plate tears through graft augmentation

Abstract

A plantar plate augmentation kit assembly and method of repairing plantar plate tears through augmentation provides an assembly of tools used to augment a plantar plate with a soft tissue graft, and specifically an Artelon Graft. The kit assembly includes a plantar plate drill guide for aligning a drill bit and K-wires over a damaged area of a plantar plate. The assembly also includes a plantar plate joint distractor for separating tissue, at least two K-wires that serve as anchors to the tissue, a drill bit for driving the graft into the tissue. The assembly also includes a graft passer for retaining and manipulating the graft. Further included are at least two interference-type screws and a screw driver for manipulating the interference-type screws. These components are stored in a storage container that includes an outer housing and multiple inner recesses shaped and sized to frictionally fit the tools.

Claims

1. A single-use plantar plate augmentation kit assembly, the assembly comprising: a plantar plate joint distractor configured to separate tissue, the plantar plate joint distractor operational between a closed position and an open position along a spreader opening path, the plantar plate joint distractor defined by a distal end forming two apertures configured to receive at least two K-wires; a plantar plate drill guide comprising a main body, a support member coupled to the main body, and a drill receiving platform, the main body of the plantar plate guide being defined by a plurality of channels, the channels being sloped at multiple angles; a drill insertion member defined by a proximal opening and a distal opening adapted to retain a drill bit, the drill insertion member sized and dimensioned to fit in the channels, whereby the drill bit is capable of being selectively oriented towards at least one of the angles of the channels; a graft passer defined by a handle end and a loop, wherein the loop is capable of retaining a graft; at least two interference screws, the interference screws defined by screw threads configured to engage and compress the graft for fixation; and a screw driver defined by a proximal end and a distal end, the distal end detachably attachable to the interference type screws, Whereby the screw driver, in use, manipulates the interference-type screws into the graft.

2. The single-use plantar plate augmentation kit assembly according to claim 1, wherein the support member is disposed at an orthogonal orientation with respect to the main body.

3. The single-use plantar plate augmentation kit assembly according to claim 1, wherein the support member, in use, couples to the main body through a fastener.

4. The single-use plantar plate augmentation kit assembly according to claim 3, wherein the fastener includes at least one of the following: a screw, a bolt, an adhesive, and a compression fitting.

5. The single-use plantar plate augmentation kit assembly according to claim 1, wherein the drill insertion member is removably couplable through the channels in a friction fit relationship.

6. The single-use plantar plate augmentation kit assembly according to claim 1, wherein the K-wires have a diameter of about 0.45 inches.

7. The single-use plantar plate augmentation kit assembly according to claim 1, wherein the plantar plate joint distractor comprises: a bolt-thread mechanism.

8. The single-use plantar plate augmentation kit assembly according to claim 1, wherein the drill bit comprises a chuck end and the drill bit is shaped and sized for insertion in the drill insertion member.

9. The single-use plantar plate augmentation kit assembly according to claim 1, wherein the drill bit is defined by a drill head and a body portion having a diameter of about 2.7 millimeters.

10. The single-use plantar plate augmentation kit assembly according to claim 1, wherein the K-wires comprise: a sterilized, sharpened, smooth stainless-steel pin.

11. The single-use plantar plate augmentation kit assembly according to claim 1, further comprising: a container defined by an outer housing and multiple inner recesses, the recesses being shaped and sized to frictionally fit at least one of the following: the plantar plate drill guide, the plantar plate joint distractor, the K-wires, the drill bit, the graft passer, the interference-type screws, and the screw driver.

12. A single-use plantar plate augmentation kit assembly, the assembly comprising: a plantar plate joint distractor configured to separate tissue, the plantar plate joint distractor comprising a bolt-thread mechanism configured to operate the plantar plate joint distractor between a closed position and an open position along a spreader opening path, the plantar plate joint distractor defined by a distal end forming two apertures configured to receive at least two K-wires having a diameter of about 0.45 inches; a plantar plate drill guide comprising a main body, a support member coupled to the main body at an orthogonal orientation, and a drill receiving platform, the main body of the plantar plate guide being defined by a plurality of channels, the channels being sloped at multiple angles; a drill insertion member defined by a proximal opening and a distal opening adapted to retain a drill bit the drill bit being defined by a chuck end shaped and sized for insertion in the drill insertion member, the drill insertion member being sized and dimensioned to fit in the channels, whereby the drill bit is capable of being selectively oriented towards at least one of the angles of the channels; a graft passer defined by a handle end and a loop, wherein the loop is capable of retaining a graft; at least two interference screws, the interference screws defined by screw threads configured to engage and compress the graft for fixation; a screw driver defined by a proximal end and a distal end, the distal end detachably attachable to the interference type screws, whereby the screw driver, in use, manipulates the interference-type screws into the graft; and a container defined by an outer housing and multiple inner recesses, the recesses being shaped and sized to frictionally fit at least one of the following: the plantar plate drill guide, the plantar plate joint distractor, the K-wires, the drill hit, the graft passer, the interference-type screws, and the screw driver.

13. The single-use plantar plate augmentation kit assembly according to claim 12, wherein the support member, in use, couples to the main body through a fastener.

14. The single-use plantar plate augmentation kit assembly according to claim 13, wherein the fastener includes at least one of the following: a screw, a bolt, an adhesive, and a compression fitting.

15. The single-use plantar plate augmentation kit assembly according to claim 12, wherein the drill insertion member is removably couplable through the channels in a friction fit relationship.

16. The single-use plantar plate augmentation kit assembly according to claim 12, wherein the drill bit has a diameter of about 2.7 millimeters.

17. The single-use plantar plate augmentation kit assembly according to claim 12, wherein the K-wires comprise: a sterilized, sharpened, smooth stainless-steel pin.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The accompanying figures, where like reference numerals refer to identical or functionally similar elements throughout the separate views and which together with the detailed description below are incorporated in and form part of the specification, serve to further illustrate various embodiments and explain various principles and advantages all in accordance with the present invention.

(2) FIG. 1 is a top view of an exemplary plantar plate augmentation assembly, showing individual close-up views of the tools and/or components used in the assembly, in accordance with the present invention;

(3) FIG. 2 is a top view of an exemplary plantar plate augmentation kit, in accordance with the present invention;

(4) FIG. 3 is a perspective view of an exemplary plantar plate drill guide, in accordance with the present invention;

(5) FIG. 4 is an elevated side view of the plantar plate drill guide, shown in FIG. 3, in accordance with the present invention;

(6) FIG. 5 is a perspective view of the plantar plate drill guide, showing the removable drill insertion member pivoting at different angles, in accordance with the present invention;

(7) FIG. 6 is a perspective view of an exemplary plantar plate joint distractor, in accordance with the present invention;

(8) FIG. 7 is a perspective view of the plantar plate joint distractor, shown in FIG. 6 in a closed position, in accordance with the present invention;

(9) FIG. 8 is a perspective view of the plantar plate joint distractor, shown in FIG. 6 in an open position, in accordance with the present invention;

(10) FIG. 9 is a perspective view of an exemplary drill bit, in accordance with the present invention;

(11) FIG. 10 is a view of the plantar plate joint distractor, in accordance with the present invention;

(12) FIG. 11 is a top view of an exemplary graft passer, in accordance with the present invention;

(13) FIG. 12 is a perspective view of the graft passer, shown in FIG. 11, in accordance with the present invention;

(14) FIG. 13 is a perspective view of a K-wire, in accordance with the present invention;

(15) FIG. 14 is an elevated side view of an exemplary interference type screw, in accordance with the present invention;

(16) FIG. 15 is a perspective view of an interference type screw, in accordance with the present invention;

(17) FIG. 16 is an elevated side view of an exemplary screw driver manipulating the interference type screw, in accordance with the present invention;

(18) FIG. 17 is a perspective view of an exemplary screw driver manipulating the interference type screw, in accordance with the present invention;

(19) FIG. 18 is an elevated side view of an exemplary soft tissue graft, in accordance with the present invention;

(20) FIG. 19 is a perspective view of the soft tissue graft shown in FIG. 18, in accordance with the present invention;

(21) FIG. 20 is a perspective view of a foot, showing the plantar fascia, plantar plate, and tendons, in accordance with the present invention;

(22) FIG. 21 is a perspective view of one step of the augmentation procedure, showing the plantar plate joint distractor separating skin to access the damaged area of the plantar plate, in accordance with the present invention;

(23) FIG. 22 is a side perspective view of a step of the augmentation procedure, showing the plantar plate drill guide positioned over the plantar plate, in accordance with the present invention;

(24) FIG. 23 is a top perspective view of a step of the augmentation procedure, showing the plantar plate drill guide positioned over the plantar plate, in accordance with the present invention;

(25) FIG. 24 is a perspective view of a step of the augmentation procedure, showing a graft being augmented across the damaged area of the plantar plate, in accordance with the present invention;

(26) FIG. 25 is a perspective view of a step of the augmentation procedure, showing the graft being manipulated across the plantar plate, in accordance with the present invention;

(27) FIG. 26 is a perspective view of a step of the augmentation procedure, showing a K-wire pulling the graft across the plantar plate, in accordance with the present invention;

(28) FIG. 27 is a perspective view of a step of the augmentation procedure, showing a drill driving the graft into the plantar plate, in accordance with the present invention; and

(29) FIG. 28 illustrates a flowchart of an exemplary method of repairing plantar plate tears through augmentation, in accordance with the present invention.

DETAILED DESCRIPTION

(30) While the specification concludes with claims defining the features of the invention that are regarded as novel, it is believed that the invention will be better understood from a consideration of the following description in conjunction with the drawing figures, in which like reference numerals are carried forward. It is to be understood that the disclosed embodiments are merely exemplary of the invention, which can be embodied in various forms.

(31) The present invention provides a novel and efficient single-use assembly kit and method of use for planter plate graft augmentation. Referring now to FIG. 1, one embodiment of the present invention is shown in a perspective top angle view. FIG. 1, along with the other figures herein, shows several advantageous features of the present invention, but, as will be described below, the invention can be provided in several shapes, sizes, combinations of features and components, and varying numbers and functions of the components. The first example of a plantar plate graft augmentation assembly, as shown in FIG. 1, includes a plantar plate drill guide, a plantar plate joint distractor, at least two K-wires, a drill bit, a graft passer, at least two interference-type screws, a screw driver, and a soft tissue graft. These tools and components are stored in a storage container 200 that effectively houses and store the tools necessary to provide the planter plate graft surgical procedure.

(32) The present invention provides a novel and efficient single-use assembly kit 100 and method 2800 of use for planter plate graft augmentation. Specifically, with reference to FIGS. 1 and 2, the assembly kit 100 provides a container, which may be designed for single use, provide instruments to perform the planter plate graft augmentation. The storage container 200 effectively houses and stores the tools necessary to provide the planter plate graft surgical procedure. In one embodiment, the container may have an outer housing 202 and multiple inner recesses 204a-n that are shaped and sized to frictionally fit the tools to prevent inadvertent dislodging of the same while in transport or in the operating room. The inner recesses 204a-n may be configured from a foam or resilient material.

(33) The assembly kit 100 may contain a plantar plate drill guide 300 (shown in more detail in FIGS. 3-5), a plantar plate joint distractor 600 (shown in more detail in FIGS. 6-8), at least two K-wires 1300a-b (shown in more detail in FIG. 13), a drill bit 900 approximately 2.7 mm in diameter (shown in more detail in FIGS. 9-10), a graft passer 1100 (shown in more detail in FIGS. 11-12), two interference type screws 1400a-b operable with a screw driver 1600 (shown in more detail in FIGS. 14-17). The above tools are used to augment a soft tissue graft 1800 (shown in more detail in FIGS. 18-19). It is the intent of the present invention to provide a cost-effective assembly kit that is easy to use and to allow the surgeon to achieve consistent operative results.

(34) FIG. 1 references a collection of components used for the plantar plate augmentation. FIG. 2 shows a storage container 200 that store the tools. FIGS. 3-19 depict individual close-up views of the tools and/or components used in the assembly kit 100 as discussed herein. FIG. 20 references an exemplary method 2800 of use for planter plate graft augmentation.

(35) Looking ahead to FIG. 20, it is recognized that the plantar plate 2002 is a fibrocartilaginous tissue that is the direct insertion of the plantar fascia 2000 into the base of the phalanges of the lesser toes. The plantar plate 2002 is situated on the underside of the metatarsal phalangeal joints at the ball of the feet, below the second cuneiform 2010 and the second metatarsal 2008. The plantar plate 2002 comprises an FDB tendon 2006 and an FDL tendon 2004. These tendons can tear or be strained when heavy use or loads are applied to the foot. Plantar plate 2002 injuries are a common foot condition that has been a challenging procedure for physicians to master. Traditionally, there are complicated suture based repair techniques that are difficult to perform and are based on a suture repair, and not graft augmentation.

(36) To aid in overcoming surgical challenges associated with plantar plate injuries, the present invention provides a planter plate graft augmentation kit 100 and method 2800 of use. Specifically, in one embodiment, the kit described below, which may be designed for single use by a physician, is designed to provide a surgeon a fast, easy, and effective way to repair the plantar plate tear. This technique uses an FDA approved soft tissue graft that augments the plantar plate structure, and specifically for reinforcement and augmentation of tissue repair, e.g. ligaments, tendons, general soft tissues.

(37) Those skilled in the art will recognize that tendons are tough, fibrous bands of tissue that attach muscles to bones. Tendons can become torn or frayed because of overuse or injury. The graft tissue used in the present invention is efficacious for protecting and reinforcing a damaged tendon in the plantar plate, helping it heal. In one non-limiting embodiment, the graft used is an FDA approved Artelon graft. The Artelon graft may be of a porous polyurethane material and acts as a scaffold which promotes ingrowth of native human tissue. Typically, the Artelon graft degrades over a period of around 5-7 years during which time most of the material is replaced by native human tissue.

(38) With reference specifically to FIG. 3, an exemplary and unique plantar plate drill guide 300 is shown. The plantar plate drill guide 300 is used to position over a damaged area of a plantar plate 2002, so as to align a drill for drilling therein. The plantar plate drill guide 300 comprises a main body 302 that is flat and linear. The main body 302 is defined by multiple channels 308a-n. The channels may have a circular shape to accommodate a circular drill, as described below.

(39) The plantar plate drill guide 300 also includes a support member 304 is disposed at a substantially orthogonal orientation with respect to the main body 302 (FIG. 4). The support member 304 holds the main body 302 and channels 308a-n over a damaged area of the plantar plate 2002. In this manner, the channel, and the drill therein is oriented to a desired angle. The support member 304 is coupled to the main body 302 using a fastener 314, adhesive, or compression fitting.

(40) Looking now at FIG. 5, the plantar plate drill guide 300 further provides a support member 304 that includes a drill receiving platform 306. The channels 308a-n may be beneficially canted at various angles to provide various insertion angles of a removable drill insertion member 310 and/or a drill bit 900. This allows drilling into the plantar plate 2002 at incremental angles.

(41) The drill insertion member 310 is a hollow cylindrical piece that may be removably couplable to the channels in the main body 302 using friction fitting and/or a fastener. The drill insertion member 310 can be seen defining the channel that accommodates a drill used in connection with the surgical procedure. The drill insertion member 310 may include a hollow body having a proximal opening 312a and distal opening 312b.

(42) The orientation of the drill insertion member 310, particularly the distal opening 312b, provides an inlet for a drill bit 900 or other drilling device to be aligned with the receiving drill receiving platform 306. Once the drill bit passes through, a drill can then rotate the drill bit at the desired angle of the selected channel 308a. This allows for drilling at or near the damaged area of the plantar plate in a precise manner.

(43) With reference specifically to FIG. 6, an exemplary plantar plate joint distractor 600 can be seen. As will be appreciated by those of skill in the art, the plantar plate joint distractor 600 can be utilized to spread muscle or other human tissue. The plantar plate joint distractor 600 is configured to expand and retract sections of tissue at or near the plantar plate. FIG. 7 depicts the plantar plate joint distractor 600 in a closed configuration 700 along a spreader opening path 702, while FIG. 8 depicts the plantar plate joint distractor 600 in an open configuration 800 along the spreader opening path 702.

(44) In some embodiments, the plantar plate joint distractor 600 may be mechanically or electro-mechanically placed in the spreader opening path 702 using, for example, a bolt-thread mechanism 602. The bolt-thread mechanism 602 may include a threaded lever that moves a pair of clamps distally and proximally relative to each other. The plantar plate joint distractor 600 can also be seen having two apertures 604a, 604b disposed toward the distal ends 606 of the plantar plate joint distractor 600, which are configured to receive at least two K-wire, described below.

(45) With reference specifically to FIGS. 9-10, the kit assembly 100 also includes a drill bit 900. The drill bit 900 is used to drive the graft into position at the damaged area of the plantar plate 2002 (See FIG. 27). The drill bit 900 may also be used to remove tissue material and form a hole at or near the damaged area of the plantar plate. The drill bit 900 is defined by a body portion 902 that terminates at a drill head 906. The body portion 902 is approximately 2.7 mm in diameter. However in other embodiments, larger or smaller diameters, however, may be utilized. The chuck end 904 of the drill bit 900 may be shaped and sized for insertion within the drill insertion member 310. A power drill then couples to the check end 904 of the drill bit 900 for driving into the plantar plate.

(46) With reference specifically to FIGS. 11-12, a graft passer 1100 is employed to facilitate in the handling of a soft tissue graft 1800, e.g., an Artelon Graft (shown in FIGS. 18-19). The graft passer 1100 has a handle end 1102 for controlling the graft passer 1100, and a loop 1104 that retains the graft 1800 during manipulation. The loop shape of the graft passer 1100 encircles the graft 1800 for alignment across the damaged area of the plantar plate during augmentation thereof.

(47) With reference specifically to FIG. 13, the kit assembly 100 provides at least two K-wires 1300a, 1300b that attach to the graft, so as to help manipulate the graft to the desired position across the damaged plantar plate 2002. The K-wires 1300a-b may also be driven into the tissue of the plantar plate for retaining the augmented tissue in the desired position; serving as anchors therein. The K-wires 1300a-b are anchored from one end to the apertures 604a-b in the distal end 606 of the plantar plate joint distractor 600. In this manner, moving the plantar plate joint distractor 600 between the open and closed configurations 800, 700 works to adjust the position of the K-wires 1300a-b.

(48) The K-wires 1300a-b may also include Kirschner wires. The two K-wire 1300a-b may be each approximately 0.45″ in diameter. Though in alternative embodiments, greater or smaller diameters may be used. K-wires 1300a-b can also be considered to be a pin. In one non-limiting embodiment, the K-wire 1300a-b is a section of sterilized, sharpened, smooth stainless steel pin.

(49) With reference specifically to FIGS. 14-15, the kit assembly also provides two interference type screws 1400a, 1400b. The interference type screws 1400a, 1400b provide a direct tendon-to-bone interference fixation device for securing the K-wires 1300a-b and graft 1800 into place. The interference type screws 1400a, 1400b are defined by screw threads 1402 that engage and compress the graft 1800 for fixation.

(50) As FIGS. 16-17 show, the kit assembly 100 also provides a screw driver 1600 defined by a proximal end 1602 and a distal end 1604. The interference type screws 1400a, 1400b detachably attach to the distal end 1604 of the screw driver 1600, such that the screw driver manipulates and inserts the interference type screws 1400a, 1400b through the graft 1800 and K-wire ends during the surgical procedure.

(51) FIGS. 1-27 are described in conjunction with the process flow chart of FIG. 28. Although FIG. 28 shows a specific order of executing the process steps, the order of executing the steps may be changed relative to the order shown in certain embodiments. Also, two or more blocks shown in succession may be executed concurrently or with partial concurrence in some embodiments. Certain steps may also be omitted in FIG. 28 for the sake of brevity. In some embodiments, some or all of the process steps included in FIG. 28 can be combined into a single process.

(52) In some embodiments, a method 2800 of repairing plantar plate tears through augmentation includes an initial Step 2802 of cutting an incision above a damaged area of a plantar plate. The area is marked prior to cutting in order to determine the appropriate incision location. The method 2800 may further comprise a Step 2804 of spreading the tissue at or near the plantar plate with a plantar plate joint distractor 600, whereby the plantar plate joint distractor is selectively expanded to an open configuration 800 along a spreader opening path 702. FIG. 21 illustrates the plantar plate joint distractor 600 separating the skin to expose the damaged tendons at or near the plantar plate 2002. A bolt mechanism 602 can be manually turned to urge the plantar plate joint distractor 600 between the open and closed positions.

(53) As illustrated in FIG. 22, a Step 2806 includes positioning a plantar drill guide over the plantar plate, the plantar drill guide comprising a main body, a support member, and a drill receiving platform, the main body being defined by a plurality of channels sloped at multiple angles. The plantar plate drill guide 300 is used to position over a damaged area of a plantar plate, so as to align a drill for drilling therein. The drill insertion member fits into the appropriate channel to guide the drill bit into the tissue (FIG. 23).

(54) In some embodiments, a Step 2808 comprises inserting a drill insertion member into one of the channels, the selected channel being dependent on a drilling angle over the tissue. The drill insertion member is a cylindrical component that helps guide the drill to the appropriate location above the plantar plate 2002. A Step 2810 includes attaching at least two K-wires to a graft (FIG. 24). The graft is an FDA approved soft tissue graft, including an Artelon graft. The K-wire is used to pull and manipulate the graft to the desired position across the damaged area pf the plantar plate 2002. FIG. 25 shows the graft positioned across the plantar plate, serving as an augmentation thereof. At this stage of the procedure, the plantar plate drill guide has been removed to provide space to manipulate the graft.

(55) Turning now to FIG. 26, a Step 2812 may include pulling, with the K-wire, the graft across a damaged area of the plantar plate, whereby the graft augments the damaged area of the plantar plate. As shown in FIG. 27, a Step 2814 comprises passing a drill bit through the graft. The drill bit drives the graft across the damaged area of the plantar plate. The method may further comprise a Step 2816 of drilling, with the drill bit, the tissue at or near the damaged area of the plantar plate. Once manipulated to the desired position for augmentation, the ends of the K-wires can be drilled into the tissue, serving as an anchor thereto.

(56) In some embodiments, the method 2800 further includes a Step 2818 includes manipulating, with a screw driver, at least two interference-type screws through the K-wires, the graft, and the plantar plate. A final Step 2820 includes removing, after a duration, the K-wires from the graft, whereby the damaged area of the plantar plate is healed.

(57) Although the process-flow diagrams show a specific order of executing the process steps, the order of executing the steps may be changed relative to the order shown in certain embodiments. Also, two or more blocks shown in succession may be executed concurrently or with partial concurrence in some embodiments. Certain steps may also be omitted from the process-flow diagrams for the sake of brevity. In some embodiments, some or all the process steps shown in the process-flow diagrams can be combined into a single process.

(58) These and other advantages of the invention will be further understood and appreciated by those skilled in the art by reference to the following written specification, claims and appended drawings. Because many modifications, variations, and changes in detail can be made to the described preferred embodiments of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalence.