Patent Application
20240180323
The present invention relates generally to a plantar plate augmentation kits and assemblies and method of repairing plantar plate tears through augmentation, and, more particularly, relates to a kit assembly and method that repairs plantar plate tears through use of an FDA approved soft tissue graft that augments the plantar plate structure through use of 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.
It is known in the art that the plantar fascia is the flat band of tissue (ligament) that connects the heel bone to the toes. The plantar fascia supports the arch of your foot. If a person strains the plantar fascia, it gets weak, swollen, and irritated. Consequently, the heel or the bottom of the foot hurts when standing or walking.
Generally, the plantar plate is a ligament that is situated on the underside of the metatarsal phalangeal joints at the ball of the feet. A plantar plate tear is a common injury of the forefoot which is caused by repetitive overload.
The plantar plate is a fibrocartilaginous tissue that is the direct insertion of the plantar fascia into the base of the phalanges of the lesser toes. Plantar plate 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.
To aid in overcoming surgical challenges associated with plantar plate injuries, the present invention provides a planter plate graft augmentation kit, assembly, and method 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.
Therefore, a need exists to overcome the problems with the prior art as discussed above.
The invention provides a single-use plantar plate augmentation kit assembly and method of repairing plantar plate tears through augmentation that overcomes the hereinafore-mentioned disadvantages of the heretofore-known devices and methods of this general type and that provides an assembly of tools used to augment a plantar plate with a soft tissue graft, and specifically an Artelon graft.
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.
The present invention provides a novel and efficient plantar plate augmentation kit assembly and method of repairing plantar plate tears through augmentation. More specifically, a single-use plantar plate augmentation kit assembly is disclosed that includes a plantar plate joint distractor with two members operably configured to move with respect to one another to have an open position configured to separate tissue and a closed position along a spreader opening path, a graft material, two wires configured to attach to the graft material, a graft passer having a handle portion and a portion of the graft passer configured to facilitate in the handling of the graft material, at least two interference screws with screw threads for securing the two wires and graft material into place, and a drill bit.
In further embodiments, the present invention includes a screw driver is utilized with a proximal end and a distal end detachably attachable to the at least two interference screws, whereby the screw driver is configured to manipulate the at least two interference screws.
In additional embodiments, the wires are K-wires and may have a diameter of about 0.45 inches. Further, the plantar plate joint distractor may include a distal end forming two apertures thereon configured to receive the at least two wires and a bolt-thread mechanism.
In an exemplary embodiment, the drill bit has a drill head and a body portion having a diameter of about 2.7 millimeters.
In further embodiment, the wires include a sterilized, sharpened, and smooth stainless-steel pin and the graft material is an elongated polyurethane material.
In a further embodiment of the present invention, a plantar plate drill guide is utilized that includes a main body, a support member coupled to the main body, and a drill receiving platform and that also includes a drill insertion member defining a proximal opening and a distal opening, adapted to retain the drill bit, and coupled to the plantar plate drill guide.
Additionally, the invention may include the main body of the plantar plate guide defining a plurality of channels sloped at multiple angles, the drill insertion member is sized and dimensioned to fit in the plurality of channels, whereby the drill bit is configured to be selectively oriented at least one of the multiple angles.
Further, the drill insertion member may be removably couplable to the plantar plate drill guide through one of the plurality of channels in a friction fit relationship and the drill bit may include a chuck end shaped and sized for insertion in the drill insertion member.
Additionally, the present invention may include a container defined by an outer housing and multiple inner 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 wires, the drill bit, the graft passer, the interference-type screws, and a screw driver.
Additionally, the support member is disposed at an orthogonal orientation with respect to the main body and the support member is configured to couple to the main body through a fastener. The fastener may include at least one of the following: a screw, a bolt, an adhesive, and a compression fitting.
Further, the graft passer may include a loop shaped and sized to retain the graft material, the drill bit is approximately 2.7 mm in diameter, and the drill bit is shaped and sized for insertion within the drill insertion member.
In accordance with a further feature of the present invention, the graft passer has a handle end for controlling the graft passer, and a loop that retains the graft during manipulation.
In accordance with a further feature of the present invention, an embodiment of the present invention includes at least two K-wires, each approximately 0.45 inches in diameter.
In accordance with a further feature of the present invention, an embodiment of the present invention includes two interference type screws with a screw driver used in the surgical procedure.
In accordance with the present invention, a method of repairing plantar plate tears through augmentation includes an initial Step of cutting an incision above a damaged area of a plantar plate. The method may further comprise a Step of spreading the tissue at or near the plantar plate with a plantar plate joint distractor, whereby the plantar plate joint distractor is selectively expanded to an open configuration along a spreader opening path.
Another Step 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. In some embodiments, a Step comprises inserting a drill insertion member into one of the channels, the selected channel being dependent on a drilling angle over the tissue. A Step includes passing a drill bit through the drill insertion member. A Step may include drilling, with the drill bit, the tissue at or near the damaged area of the plantar plate.
In some embodiments, a Step comprises positioning a graft over a damaged area of the plantar plate, whereby the graft augments the damaged area of the plantar plate. The method may further comprise a Step of passing, with a graft passer, at least two K-wires through the graft and the plantar plate. A Step includes manipulating, with a screw driver, at least two interference-type screws through the graft and the plantar plate. A final Step includes removing, after a duration, the K-wires from the plantar plate, whereby the damaged area of the plantar plate is healed.
Although the invention is illustrated and described herein as embodied in a plantar plate augmentation kit assembly and method of repairing plantar plate tears through augmentation, it is, nevertheless, not intended to be limited to the details shown because various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope and range of equivalents of the claims. Additionally, well-known elements of exemplary embodiments of the invention will not be described in detail or will be omitted so as not to obscure the relevant details of the invention.
Other features that are considered as characteristic for the invention are set forth in the appended claims. As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which can be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one of ordinary skill in the art to variously employ the present invention in virtually any appropriately detailed structure. Further, the terms and phrases used herein are not intended to be limiting; but rather, to provide an understandable description of the invention. 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. The figures of the drawings are not drawn to scale.
Before the present invention is disclosed and described, it is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. The terms “a” or “an,” as used herein, are defined as one or more than one. The term “plurality,” as used herein, is defined as two or more than two. The term “another,” as used herein, is defined as at least a second or more. The terms “including” and/or “having,” as used herein, are defined as comprising (i.e., open language). The term “coupled,” as used herein, is defined as connected, although not necessarily directly, and not necessarily mechanically. The term “providing” is defined herein in its broadest sense, e.g., bringing/coming into physical existence, making available, and/or supplying to someone or something, in whole or in multiple parts at once or over a period of time.
As used herein, the terms “about” or “approximately” apply to all numeric values, whether or not explicitly indicated. These terms generally refer to a range of numbers that one of skill in the art would consider equivalent to the recited values (i.e., having the same function or result). In many instances these terms may include numbers that are rounded to the nearest significant figure. In this document, the term “longitudinal” should be understood to mean in a direction corresponding to an elongated direction of the assembly kit.
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.
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.
The present invention provides a novel and efficient single-use assembly kit and method of use for planter plate graft augmentation. Referring now to
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
The assembly kit 100 may contain a plantar plate drill guide 300 (shown in more detail in
Looking ahead to
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.
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.
With reference specifically to
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 (
Looking now at
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.
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.
With reference specifically to
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.
With reference specifically to
With reference specifically to
With reference specifically to
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.
With reference specifically to
As
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.
As illustrated in
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 (
Turning now to
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.
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.
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.
This application is a continuation patent application which claims priority to divisional patent application Ser. No. 17/397,624 filed Aug. 9, 2021, which claims priority to nonprovisional application Ser. No. 16/357,295, filed Mar. 18, 2019, which claims priority to provisional patent application No. 62/644,401 filed Mar. 17, 2018, the entirety of which is incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11896244 | Aug 2007 | US |
| Child | 18440663 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11083472 | Mar 2005 | US |
| Child | 18440663 | US |
