Patent Application
20050234377
The present invention relates to the field of orthotics, and, more particularly, to an orthotic device including a vacuum feature to effectively prevent the loss of firm contact between the treatment site and the device.
Bracing is a technique used with great frequency in the management of a large variety of medical conditions, that is, traumatic, developmental, degenerative and congenital. Braces are used as stabilizing or corrective devices in patients of all ages. Braces are also used to lessen pain and disability as in the case of the painful back, or for the prevention and/or correction of progressive deformities, as in the case of scoliosis. Similarly, they are used for the prevention and control of progression in the case of the osteoporotic spine or the spine affected with neoplasms of various types.
Another area where braces are widely used is in the treatment of fractures. They are used either as initial stabilizers or as devices to prevent deformity at the fracture site, while permitting the functional use of the injured extremity or area.
For example, U.S. Pat. No. 6,066,107 to Habermeyer discloses a double-walled cuff-forming cushion which can be deformed into a sleeve. A plurality of loose particulate filling bodies is provided in the inner space of the cuff-forming cushion between the two walls and the cushion can be consolidated by evacuation into a stiff structure. An outer plastic shell is secured to the sleeve with hook and loop fasteners.
Typically, when using an orthosis it is important to maintain close contact between the treatment area and the orthotic device. Otherwise, the inevitable reduction in the degree of swelling that necessarily follows an injury, produces a loss of “fit” of the brace, resulting in the creation of deformities at the fracture site. With traditional braces, frequent tightening of the fit of the appliance is strongly urged. However, compliance with such a request is frequently ignored, or the value of the advice is not truly understood.
Accordingly, there is still a need for an orthotic device to effectively prevent the loss of firm contact between the treatment site and the device.
The present invention includes a vacuum system and orthotic device used in the treatment of fractures to effectively prevent the loss of firm contact between the injured limb and the brace, therefore minimizing and/or eliminating the traditional adverse changes.
The invention applies to orthotic devices used in the treatment of other conditions such as spine pain or fractures, post-operative conditions such as spine fusion or laminectomies. The invention equally applies to braces used after joint surgery or various types, such as arthroscopy, internal fixation of fractures of the upper and lower extremities, foot and hand.
The present invention is directed to a vacuum orthotic device and method including the use of an inner sleeve, a single or multi-piece shell, and an outer sleeve. The shell is positioned between the sleeves and typically includes a fabric liner or other porous material to act as a wick. A valve is preferably provided in the outer sleeve for drawing air from between the inner and outer sleeves, i.e. to create a vacuum. The sleeves overlap and sealingly contact each other at the proximal and distal ends of the orthotic device.
The sleeves are preferably made of polyurethane, and may be tubular and slidable onto the patient's arm or leg, or the sleeves may be wrap-around type sleeves with a sealing edge, e.g. sealing tape, to ease the installation of the sleeves and brace. The shell may be a multi-piece unit including anterior and posterior shell portions which are fit to provide some overlap with each other at the edges. Alternatively, the shell may be a single piece unit with an opening, and flexible enough to allow opening of the shell for installation on the patient's arm or leg, for example. Such a single piece unit may also include an integrated hinge, such as a thinned wall portion opposite the opening to ease the opening of the shell.
A disconnectable hand-pump or otherwise actuated pump may be used to connect to the valve and draw the vacuum between the sleeves. Furthermore, an external, internal or integrated tank or rigid reservoir may be included to hold a vacuum.
A method aspect of the present invention includes treating a body portion with the orthotic device. The method includes surrounding the body portion with an inner sleeve, positioning an outer sleeve over the inner sleeve and sealingly contacting the inner sleeve at proximal and distal ends thereof and defining a vacuum chamber therebetween. A hard shell is positioned between the inner and outer sleeves and includes a porous shell liner adjacent the inner sleeve. The vacuum chamber is evacuated via a valve in the outer sleeve.
The present invention will now be described more fully below with reference to the accompanying drawings, in which preferred embodiments of the invention are shown. This invention may include different embodiments and should not be construed as limited to the embodiments set forth below. These embodiments are provided so that the disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Like numbers refer to like elements throughout the description.
The present invention includes a vacuum system and orthotic device or brace used in the treatment of a body portion, such as a fractured extremity, to effectively prevent the loss of firm contact between the body portion and the device, therefore minimizing, if not eliminating the traditional adverse changes resulting in a loss of fit, for example. The following embodiment is described with respect to a fractured leg; however, the invention applies to various body portions including the trunk, neck and extremities.
The invention applies to orthotic devices used in the treatment of other conditions such as spine pain or fractures, post-operative conditions such as spine fusion or laminectomies. The invention equally applies to braces used after joint surgery or various types, such as arthroscopy, internal fixation of fractures of the upper and lower extremities, foot and hand.
Referring now to
The sleeves are preferably made of polyurethane, and may be tubular and slidable onto the patient's arm or leg, or the sleeves may be wrap-around type sleeves 20′/24′ (e.g. as shown in
A disconnectable hand-pump 30 or otherwise actuated pump may be used to connect to the valve 26 and draw the vacuum between the sleeves. Furthermore, an external 32, internal 34 or integrated tank or rigid reservoir may be included to hold a vacuum.
A method aspect of the present invention includes treating a body portion with the orthotic device 15. The method includes surrounding the body portion with an inner sleeve 20, positioning an outer sleeve 24 over the inner sleeve and sealingly contacting the inner sleeve at proximal B and distal C ends thereof and defining a vacuum chamber 27 therebetween. A hard shell 21/22 or 23 is positioned between the inner and outer sleeves and includes a porous shell liner 25 adjacent the inner sleeve. The vacuum chamber 27 is evacuated via a valve 26 in the outer sleeve.
Advantages of the orthotic device of the present invention include, but are not limited to: volume control; wound healing; maintaining intimate fit of brace and improving patient compliance with fracture orthosis due to the importance of total contact and an intimate fit with the fracture orthosis over the effected site. In the past as the patient's affected area would lose contact due to volume loss and the squeezing effect of the brace at the site, the patient would have to tighten the brace up by hand which resulted in patient compliance issues and only a certain amount of tightening could be accomplished by the patient or practitioner.
With the orthotic device of the present invention, i.e. the Sarmiento Vacuum Orthosis, the tissue rehydration is being accomplished by the vacuum effect being placed on the effected site keeping loss of fluid to that area to a minimum. This in turn improves healing and provides another option to surgery.
The above presents a description of the best mode contemplated for a vacuum orthotic device according to the present invention, and of the manner and process of assembling and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains to make and use this device. The embodiments described herein are, however, susceptible to modifications and alternate constructions which are fully equivalent. Consequently, it is not the intention to limit this invention to the particular embodiments disclosed. On the contrary, the intention is to cover all modifications and alternate constructions coming within the spirit and scope of the invention as generally expressed by the following claims, which particularly point out and distinctly claim the subject matter of the present invention.
This application claims the benefit of U.S. Provisional Application No. 60/532,255 filed on Dec. 23, 2003.
| Number | Date | Country | |
|---|---|---|---|
| 60532255 | Dec 2003 | US |
