Patent Application
20110054627
This invention generally relates to implants for surgical treatment of joints, particularly implants for surgical treatment of symptomatic trapezio metacarpal joint arthritis and symptomatic arthritis of the scapho trapezial trapezoid (STT) joint.
Trapeziometacarpal arthritis is common condition affecting a large number of adults. Trapezium excision with and without anterior oblique ligament reconstruction/soft tissue interposition are common surgical treatment options for symptomatic trapezio metacarpal arthritis. Proximal migration of the thumb metacarpal with subsequent first metacarpal scaphoid impingement, clinically significant scapho trapezoid arthritis, and first/second metacarpal impingement are known causes of persistent pain after primary and revision trapeziometacarpal joint arthroplasty where the entire trapezium or a portion of the trapezium is resected. Loss of thumb length with and without first metacarpal scaphoid impingement is thought to be a cause of pain and weakness in failed trapezium excision surgery. There are currently no known biologic commercially available implants designed exclusively for treatment of primary or revision trapeziometacarpal arthritis with or without scapho trapezial trapezoid arthritis.
Arthritis of the scapho trapezial trapezoid (STT) joint is a known condition that can cause significant wrist and hand pain. Current treatment options for STT arthritis include STT joint fusion, partial or complete trapezial resection with partial trapezoid resection, partial or complete trapezial resection with partial trapezoid resection with autograft soft tissue interposition, distal pole scaphoid excision with and without soft tissue interposition. There is currently no known consensus on an optimal surgical treatment modality. STT fusion is technically difficult and significantly reduces wrist motion. There is significant morbidity concerns and complications associated with STT fusion in published peer reviewed medical journals. Trapezial resection with partial trapezoid resection is indicated if concomitant symptomatic trapeziometacarpal arthritis is present. It is not indicated for isolated symptomatic STT arthritis without trapeziometacarpal arthritis. Distal pole scaphoid excision with and without allograft interposition is an option for symptomatic STT arthritis. There are concerns that volar flexion of the scaphoid may occur with distal pole scaphoid excision and that this may be a risk factor for carpal instability and arthritis and secondary to carpal instability. There are currently no known biologic or synthetic commercially available implants designed for the treatment of isolated STT arthritis.
The invention provides novel implants and methods for surgical treatment of symptomatic trapezio metacarpal joint arthritis and isolated STT arthritis. These and other advantages of the invention, as well as additional inventive features, will be apparent from the description of the invention provided herein.
One inventive aspect is direct toward an arthroplasty spacer. The arthroplasty spacer is formed of a biologic soft tissue and includes a body configured to fit in an arthroplasty space.
According to one embodiment, the arthroplasty spacer has the body, which is configured to replace a resected trapezium for a trapezio metacarpal joint arthroplasty. In this embodiment the body is configured to be slightly larger than the resected trapezium. The body can have a rectangular box like shape and can also include a radial extension extending generally vertically upward from a first side of the body. The body is placed in the arthroplasty space created from the resected trapezium, and the radial extension is placed adjacent a thumb radial metacarpal base to prevent lateral subluxation of the thumb metacarpal.
According to another embodiment, the arthroplasty spacer can further include a scaphotrapezoid extension extending generally horizontally from a second side of the body, the first side and the second side being on opposite ends of the body, such that the radial extension, the body, and the scaphotrapezoid extension form a stair-like shape. In this embodiment, the scaphotrapezoid extension is configured to cover an approximate area of a scapho trapezoid joint and interposed into the scapho trapezoid joint in an arthroplasty space created from a partial resection of a trapezoid to resurface an arthritic scapho trapezoid joint.
According to yet another embodiment, the arthroplasty spacer can also include a first/second metacarpal extension extending generally vertically upward from the second side of the body, such that the first/second metacarpal extension and the second side of the body and the scaphotrapezoid extension generally form L-like shape, and the radial extension and a third side of the body and the first/second metacarpal extension generally form a U-like shape. The first/second metacarpal extension is place between first and second metacarpals to provide a soft tissue interposition.
According to another embodiment, the body of the arthroplasty spacer is configured to fit the arthroplasty space created from a partial resection of a distal scaphoid to resurface an arthritic scapho trapezial trapezoid (STT) joint.
The arthroplasty spacer according to various embodiments of the present invention can be formed of human allograft, autograft or xenograft tissues, which can be selected from a group consisting of tendon, dermal, fibro cartilage, labral, meniscal tissues and a mixture thereof. Further, the body of the arthroplasty spacer can be a compact block of biologic soft tissue formed by folding or manipulating the biologic soft tissue onto itself or sectioning, which is sewn together using a suture.
Another inventive aspect is directed toward a method for surgically treating symptomatic trapezio metacarpal joint arthritis. The method includes steps of removing a trapezium; preparing an arthroplasty space created from the removed trapezium, such that the arthroplasty space is mobile and free of scar tissue; measuring a size of the arthroplasty space; selecting a biologic soft tissue spacer according to the size of the arthroplasty space; placing the biologic soft tissue spacer in the arthroplasty space; and securing the biologic soft tissue spacer to a scaphoid. In some embodiments, the biologic soft tissue spacer is formed of human allograft, autograft or xenograft tissues and configured to replace the trapezium. In such embodiments, the biologic soft tissue spacer includes a body, which is configured to be slightly larger than the trapezium.
According to one embodiment, the biologic soft tissue spacer further includes a radial extension. In such embodiment, placing the biologic soft tissue spacer includes arranging the body in the arthroplasty space created from the removed trapezium, and placing the radial extension adjacent a thumb radial metacarpal base to prevent lateral subluxation of the thumb metacarpal. The method can further include securing the radial extension to the thumb radial metacarpal base by suturing to local soft tissue at the thumb radial metacarpal base or via a bone tunnel or a suture anchor placed in the thumb radial metacarpal base.
According another embodiment, the method further includes a step of resecting about 2-3 mm of a proximal trapezoid, and preparing a scapho trapezoid arthroplasty space created therein. In this embodiment the biologic soft tissue spacer is selected to include a scaphotrapezoid extension extending from the body. The step of placing the biologic soft tissue spacer includes arranging the body in the arthroplasty space created from the removed trapezium and placing the scaphotrapezoid extension in the scapho trapezoid arthroplasty space to also treat a symptomatic scapho trapezial arthritis.
According to yet another embodiment, the biologic soft tissue spacer further includes a first/second metacarpal extension. In this embodiment, the step of placing the biologic soft tissue spacer includes arranging the body in the arthroplasty space created from the removed trapezium and placing the first/second metacarpal extension between a first metacarpal and a second metacarpal to provide a soft tissue interposition to treat a symptomatic first/second metacarpal arthritis or impingement.
In one embodiment, securing the biologic soft tissue spacer includes placing a suture anchor into around the center of a distal pole of the scaphoid, securing a suture having limbs to the suture anchor, passing the limbs through the biologic soft tissue spacer, and tying the limbs together on a radial side of the biologic soft tissue spacer, such that the biologic soft tissue spacer is secured to the scaphoid.
When a volar approach is used, the method further includes a step of repairing a thenar musculature and a remaining capsule over the biologic soft tissue spacer. When a dorsal approach is used, the method includes a step of repairing capsule over the biologic tissue spacer using non-absorbable sutures.
Yet another inventive aspect is directed toward a method for surgically treating symptomatic arthritis of scapho trapezial trapezoid (STT) joint. The method includes steps of resecting about 2-3 mm of a distal scaphoid to create an arthroplasty space; measuring a surface area of the distal scaphoid in the STT joint; selecting a biologic soft tissue spacer according to the surface area of the distal scaphoid; placing the biologic soft tissue spacer in the arthroplasty space; and securing the biologic soft tissue spacer to the distal scaphoid.
According to one embodiment, the step of placing the biologic soft tissue spacer includes deviating a wrist ulnarly and setting the biologic soft tissue spacer in the STT joint such that the biologic soft tissue spacer generally covers the entire distal scaphoid. The step of securing the biologic soft tissue spacer includes placing a suture anchor into the distal scaphoid before setting the biologic soft tissue spacer in the STT joint, and passing limbs of a suture anchor suture through the biologic soft tissue spacer, and tying the limbs together on a radial side of the biologic soft tissue spacer, such that the biologic soft tissue spacer is secured to the scaphoid.
The method can further include steps of placing a non-absorbable suture through the dorsal half of the biologic soft tissue spacer in a mattress fashion, and passing the suture through a dorsal STT joint capsule and through a overlaying extensor carpi radialis longus tendon. The method can also include steps of confirming that a scapholunate angle is 60° or less using a flouroscopic imaging, and placing a smooth 0.045″, 0.055″ or 0.065″ K-wire through a distal third of the scapohid in a radial to ulnar direction and driving the K-wire into a capitate using a power drill to stabilize the scaphoid. Then the suture is tied to stabilize a distal pole of the scaphoid to the dorsal capsule and the overlaying extensor carpi radialis brevis tendon to prevent volar flexion of the scaphoid.
Other aspects, objectives and advantages of the invention will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings.
The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention and, together with the description, serve to explain the principles of the invention. In the drawings:
While the invention will be described in connection with certain preferred embodiments, there is no intent to limit it to those embodiments. On the contrary, the intent is to cover all alternatives, modifications and equivalents as included within the spirit and scope of the invention as defined by the appended claims.
Implants according to various embodiments of the present invention are designed to be simple to use, effective and time efficient. It obviates the need for autograft graft harvesting therefore reducing anesthesia and operating room time. It is more durable than auto graft tendon and will create a more durable resurfacing and arthroplasty spacer. The material properties of the implant are such that it is easy to use and stable after suture fixation. Traditional tendon interposition arthroplasty can be difficult to reliably secure to bone and maintain position in the arthroplasty space without extrusion with loading of the joint.
The implants according to embodiments of the present invention are designed to be utilized in primary and/or revision trapezio metacarpal joint arthroplasty procedures. It is designed as a xenograft , allograft or autograft soft tissue spacer to maintain first carpometacarpal joint arthroplasty space and overall thumb length status post trapezium excision for first carpometacarpal joint arthritis. The implants can also be used in treatment of symptomatic trapeziometacarpal arthritis with concomitant symptomatic scaphotrapezoid arthritis, andin treatment of failed first carpometacarpal arthroplasty surgery when first metacarpal scaphoid impingement or first metacarpal second metacarpal impingement occurs. Further, the implants can be used in revision and/or primary trapezio metacarpal joint arthroplasty procedures in the treatment of symptomatic arthritis of the trapezio metacarpal joint with concomitant symptomatic scaphotrapezoid arthritis. It also can be utilized in younger higher demand patients with symptomatic arthritis of the trapezio metacarpal joint with or without symptomatic scaphotrapezoid arthritis where preservation of thumb length and first carpo metacarpal arthroplasty space is thought to be important.
There are right and left implants for each design. The implants can be configured according to the size of the trapeziometacarpal joint that is being reconstructed. For example, it is contemplated that up to three standard sizes of each design can be made available to fit various sized trapeziometacarpal joints. The implants 100, 200, 300 can be fabricated by folding or manipulating the allograft, xenograft or auto graft tissue onto itself or sectioning it to the appropriated size and machine sewn together with suture to create a compact block of tissue approximating the size of the trapezium.
Now that the implants according to various embodiments of the present invention have been described, methods of using the implants for surgical treatment of symptomatic trapezio metacarpal join arthritis will be discussed.
An implant according to an embodiment of the present invention is designed as a soft tissue arthroplasty spacer that resurfaces the arthritic STT joint with a durable biologic material. It is also designed to stabilize the distal scaphoid to prevent volar flexion and carpal instability. It is designed to be simple to use, effective and time efficient. It obviates the need for autograft harvesting therefore reducing anesthesia and operating room time. It is more durable than auto graft tendon and will create a more durable resurfacing and arthroplasty spacer. The material properties of the implant are such that is easy to use and stable after suture fixation. Traditional tendon interposition arthroplasty can be difficult to reliably secure to bone and maintain position in the arthroplasty space without extrusion with loading of the joint.
This implant is designed as a durable biologic soft tissue spacer that resurfaces the arthritic STT joint resulting is significant symptomatic pain relief for patient with symptomatic STT arthritis that has not responded to conservative treatment. It is also designed to stabilize the distal pole of the scaphoid to prevent volar flexion and carpal instability.
The implant 400 is designed to be placed through a volar or dorsoradial approach. According to one embodiment, approximately 2-3 mm 423 of distal scaphoid 422 is resected creating an arthroplasty space 425 as shown in
The patient is placed into a thumb spica forearm based splint with the wrist slightly ulnarly deviated. At eight weeks status post surgery the “K” wire is removed and the wrist is mobilized. Strengthening is begun at ten weeks s/p surgery.
All references, including publications, patent applications, and patents cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.
The use of the terms “a” and “an” and “the” and similar referents in the context of describing the invention (especially in the context of the following claims) is to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.
Preferred embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Variations of those preferred embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.
CROSS-REFERENCE TO RELATED PATENT APPLICATION This patent application claims the benefit of U.S. Provisional Patent Application No. 61/238,745, filed Sep. 1, 2009, the entire teachings and disclosure of which are incorporated herein by reference thereto.
| Number | Date | Country | |
|---|---|---|---|
| 61238745 | Sep 2009 | US |
