Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace
Reexamination Certificate
2000-05-10
2001-03-06
Brown, Michael A. (Department: 3764)
Surgery: splint, brace, or bandage
Orthopedic bandage
Splint or brace
C602S022000, C128S880000
Reexamination Certificate
active
06196985
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed to orthopedic products, and more particularly to a splint which is secured around the wrist with an extension portion for the thumb, often identified as a “wrist splint with thumb spica” or a “wrist splint with abducted thumb”.
BACKGROUND OF THE INVENTION
Orthopedic supplies for addressing problems with the thumb are known. A “thumb guide” published by the Assignee of the subject Application is exemplary of the prior art. This “thumb guide” (Brochure B5-025161) is made of record in this Application through the concurrent filing of an Information Disclosure Statement and PTO Form-1449. More specifically it is the Applicant's product, as exemplified by Models No. 25-160 Series; 25-170002 and 25-120003.
The subject products are known as sewn orthopedic soft appliances and braces. The only means to obtain the rigidity necessary to stabilize the injured joint is by using metal or plastic straps referred to as “stays”. The stays are actually sewn into the product identified in
FIG. 1
of the drawings as Prior Art
1
. To be noted is the abducted hand piece at the top portion which is shown in reverse appearance as in Prior Art
2
. In Prior Art
1
it will be seen that there is a stay which is positioned, curved and secured by webbing.
More particularly, as shown in Prior Art
2
, internal binding and internal seams are positioned around a thumb engaging portion of the splint. While the stay as shown is acceptable, it leaves something to be desired since the subject stay does not easily conform to the patient to give all the necessary support and immobilization. Moreover, some stays may be too rigid, and are too uncomfortable, or even worse will “dig” into the skin.
While low temperature formable plastic closed-cell polyolefin are known and have been used as splinting materials in a number of orthopedic products, they have not been readily used in sewn orthopedic soft appliances of the type discussed. The particular material involved is known by the Trademark VOLARA®. VOLARA® foam is formable through a variety of techniques at temperatures normally not exceeding 200° F. In addition, the product can be stitched or sewn with traditional yarns or threads.
In addressing the problem of the patient, the best immobilization of the wrist is obtained by immobilizing both the wrist and the thumb. By stabilizing the dorsal and palmar aspects of the wrist, flexion, extension, and rotation of the radius and ulnar is prevented. This type of stabilization is typically achieved with traditional wrist splints with palmar and dorsal stays. By immobilizing the Metacarpophalangeal (MCP) and basal joints of the thumb, the carpal bones of the wrist are held stable and radial/ulnar deviations are limited. This type of stabilization is typically achieved with traditional thumb spicas. The best and complete immobilization of the wrist can be obtained by combining a wrist splint with a thumb spica. This type of product is especially beneficial in post-surgical treatment of wrist and thumb injuries. However, and in addition, the same can be used to address treatment of the Basal Joint Arthritis; DeQuervain's Tenosynovitis; tendonitis; cumulative trauma disorders of the thumb and wrist; severe wrist sprains; strains/sprains of the thumb joint (MCP); wrist sprains in the Carpal region; advanced Carpal Tunnel Syndrome; or after cast removal for severe wrist fractures. Historically, wrist splints with abducted thumb pieces have been employed in these applications. To be noted, again referencing both Prior Art drawings, the abducted thumb piece is constructed with metal stays and does not conform comfortably to provide adequate immobilization with a cradle like effect on the thumb.
SUMMARY OF THE INVENTION
The present thumb wrist splint begins with the formation of the main body portion which includes a plurality of straps for encircling the wrist and securing the same firmly to the wrist with desirable palmar and dorsal stays. Thereafter, the sewn thumb spica/splint is fabricated, and finished by normal binding around the periphery. The thumb strap loop is fixed to the splint and a removable securable anchor is also applied to the spica/splint. The spica/splint is a VOLARA® grade polyolefin closed foam material which is desirably laminated to nylon cloth on one side. Thereafter, the sewn thumb spica is secured to the main body portion. At this point the product is flat and has no particular configuration. Thereafter, the entire blank, as just described, is positioned over an anvil intended to form a curvilinear pattern to the thus encapsulated VOLARA® so that it will conform to the lower forearm, wrist and thumb. Once secured in place on the wrist by means of the straps around the wrist portion, the thumb strap is secured. All of the above are desirably assisted by a web applied for assistance to convert the entire splint into a sock like configuration into which the wrist and hand are inserted. Thereafter, as suggested, the wrist straps are snugly secured and desirably reversely folded and removably secured to anchor portions, followed by wrapping elastic loop thumb strap. The elastic web, and the elastic loop thumb strap, are normally expandable by at least 20% to 40%. The method of the product further contemplates heating the blank as formed and recited above, and thereafter positioning the same over an Anvil or male mold, and thereatop pressure engaging the upper portion with a mating female mold which will cause the VOLARA® to take on the shape of the male/female mold relationship and reshape to a new form. In this process, that portion of the removed end of the thumb spica is provided with pinch points which assist in further cradling the thumb when the entire splint has been secured to the wrist and the thumb of the patient.
In view of the foregoing it is a principle object of the present invention to provide a combination of a wrist splint with a contoured thumb spica piece which ensures the practical immobilization of the wrist and thumb without interior seams and other obstructions that can irritate the skin and which are assisted by a formed angled splint.
Yet another object of the present invention is to provide such a thumb wrist splint in which the injured thumb MCP joint and/or Carpal joint of the wrist are shielded from further impact or shock. The cushioning of the VOLARA® foam provides a much better shield from such shock than a metal or plastic stay along the medial side of the wrist and hand. This results in a more comforting fit, provides a layer of foam protection, and eliminates the use of rigid metal around the sensitive MCP and Carpal joints.
Moreover, the subject product is simple and easy to sew because of the size and shape of the thumb opening. Internal stitch seams, joints and bindings, such as shown in the prior art drawing, are unavoidable due to the difficult construction of the prior art splints. Such stitch seams, as in the prior art, form pressure points that can be uncomfortable and cause aggravating pain to the sensitive joints. With the present invention such internal seams are eliminated. The entire spica portion is secured to the main body portion without seams, binding, or joints around the thumb. That renders the thumb completely and comfortably immobilized and affords protection in an unabrasive environment.
Yet another object of the present invention is to provide a thumb wrist splint which is easy to put on without third party assistance to the patient; the same result being achieved by the wrist web which gives a sock like appearance to the product when the hand of the patient is inserted therein.
Yet another object of the present invention is to achieve all of the above objects and advantages with a construction method that is inherently economical to manufacture, and in which the hand stitching and other steps are minimized.
REFERENCES:
patent: 4716892 (1988-01-01), Brunswick
patent: 5350418 (1994-09-01), Janevski
patent: 5356371 (1994-10-01), Hubbard
patent: 5513657 (1996-05-01), Nelson
Brown Michael A.
Fla Orthopedics, Inc.
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