Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace
Reexamination Certificate
1999-12-10
2001-02-20
Smith, Jeffrey A. (Department: 3732)
Surgery: splint, brace, or bandage
Orthopedic bandage
Splint or brace
Reexamination Certificate
active
06190343
ABSTRACT:
TECHNICAL FIELD
The invention relates to orthotic devices used in the treatment of spinal disorders and/or used subsequent to surgery where forward flexing of the torso is to be minimized. More particularly, the invention relates to orthotic devices employed for partial or substantial immobilization of portions of the torso and having multiple modes of adjustment facilitating both rapid donning and doffing and individualized adjustment to custom fit the user of the device.
BACKGROUND ART
A common method of alleviating pain in people suffering from back injuries and promoting healing in post-operative back surgery patients is to stabilize the spine by means of an orthosis, such as a brace. Such braces include a multitude of materials and designs which can be snugly fitted around the patient's trunk. In certain applications, the back portion of the orthosis may be provided with pockets into which are inserted lordotic pads for treating spinal lordosis.
Such braces are effective in achieving spinal stability if worn properly and consistently; however, most patients have difficulty in manually adjusting the brace to fit tightly enough to provide adequate support. This is especially true in the case of post-operative and older patients who are generally in pain and frequently lack sufficient strength to make the necessary adjustments. For many patients suffering spinal ailments, these braces are also difficult to don and doff, appropriately position and fasten and subsequently remove. In addition, because of the structures of many of these devices and/or the choice of materials used in their construction, the orthoses are quite uncomfortable, in many instances inducing extensive perspiring and/or chafing. Without being consistently worn and properly adjusted, such patient non-compliance obviously reduces the effectiveness of the device.
Another frequently encountered problem with these types of orthoses is their inability to conform to the torso as the patient moves from a standing to a sitting position or vice versa. Thus, although such a device may have been initially properly adjusted, once the patient has changed position, it may be necessary to make additional adjustments manually to vary the tension, depending on whether the patient is standing or sifting. Similar situations and corresponding adjustments may be required as, or shortly after, a meal is consumed or digested.
Advances have been made in recent years to provide orthotic devices which can be more easily adjusted to the individual patient and readjusted when their physical position changes. Thus, in U.S. Pat. No. Re 35,940 an electromechanical back brace apparatus is described which is provided with an electromechanical mechanism for tightening the brace around the trunk of the patient to a desired tension. A cable and pulley arrangement is tightened by a small motor to provide the desired tension in the brace. A microprocessor is also provided to control the motor to obtain desired repeatable tension settings. While such a device facilitates rapid and repeatable adjustment of such a brace, the inclusion of an electromechanical mechanism and a microprocessor increases the cost of such a device to a patient or to their medical insurance program. In addition, there is the need to periodically replace batteries to power the electrically operated components.
In the treatment of certain specific abnormalities of the spine and some postoperative conditions, a cruciform anterior spinal hyperextension orthosis is well known and has been widely used with success. For example, in many instances, the condition of a patient requires that their torso be immobilized so that they do not bend the upper torso forward. With such devices used heretofore, a common type of cruciform anterior spinal hyperextension system applies pressure to the front or anterior of the thoracic and pubic areas of the human body in combination with a back pad and straps or similar arrangement in order to tension the front and back structures to cause hyperextension of the posterior lumbar region of the body. Typical devices include a front structure having upper and lower arms and right and left arms, the upper and lower arms including an appropriate pad to be placed in contact on the sternal and pubic areas of the human body. The front structure is combined with a back or lumbar pad, the latter being adjustably connected to the left and right arms by straps or similar arrangement. The device may be suitably tensioned to apply the necessary forces to hyperextend the patient's back. Frequently, the problems associated with such devices are that they are generally difficult and time consuming to adjust and readjust.
Accordingly, it is an object of the present invention to provide orthotic devices which result in greater patient compliance since the key to successful orthotic treatment is patient compliance. The attributes of an effective orthotic device which induces patient compliance includes ease of donning an doffing the device, ease of adjusting the device, comfort to the wearer of the device, and effective heat dissipation. More specifically, it is a primary object of this invention to provide orthoses which may be tightened around the torso of a patient to provide the necessary support and immobilization of the spine with the minimal physical effort required on the part of the patient.
It is a further object of the present invention to include individual controls for adjustment and custom fitting of different parts of the orthotic device.
It is another object of the present invention to provide multiple modes of adjustment to achieve individualized adjustment of various portions of orthosis. It is still another object of the present invention to provide multiple and independent means of adjustment of various portions of an orthotic device.
It is yet another object of the present invention to provide a rigid orthotic apparatus having a significant mechanical advantage that may be individually adjusted to a desired tension. It is yet another object of the present invention to provide a cruciform anterior spinal hyperextension which includes multiple means of adjustment for individually fitting the orthosis to a patient.
It is another object of the invention to provide an orthotic device which is capable of being rapidly adjusted and, where appropriate, readjusted to an appropriate tension. It is another object of the present invention to allow the orthotic device to be easily dissembled to clean component parts of the device. It is another object of the invention to provide orthoses which are easily donning and doffed. It is also an object of the invention to provide orthoses which are comfortable and which have minimal points of contact with a patient's body, thereby minimizing chafing.
It is a further object of the present invention to provide a cruciform anterior spinal hyperextension orthosis which contacts the human body at three points, the lumbar region of the back, the sternum and the pubic area.
It is still another object of the invention to provide a cruciform anterior spinal hyperextension system having a rear portion which serves as both as a paraspinal support which also incorporates a means for adjusting the orthosis.
DISCLOSURE OF INVENTION
The present invention is directed to braces and orthotic devices which result in significantly increased patient compliance. This is attributable to orthoses that are both easily donned and doffed as well as being easily and rapidly adjustable to accommodate changes in the position of a wearer of the device. The orthotic devices of the invention include multiple modes of adjustment which are independently adjustable to accommodate and conform to varying physical profiles of a user of the device as well as to accommodate a change in the position of the torso about which the devices are secured. The devices of the invention provide greater patient comfort and adjustability and result, therefore, in greater patient compliance. Preferably, component parts of the devices may be easily disse
Heinz Thomas J.
Park Dae Shik
Arent Fox Kintner & Plotkin & Kahn, PLLC
Bio Cybernetics International
Smith Jeffrey A.
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