Surgery: kinesitherapy – Kinesitherapy – Device with applicator having specific movement
Reexamination Certificate
1999-09-10
2001-07-03
Brown, Michael A. (Department: 3764)
Surgery: kinesitherapy
Kinesitherapy
Device with applicator having specific movement
C602S075000, C606S201000, C606S204000
Reexamination Certificate
active
06254554
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a sleeve apparatus for applying compressive pressure to a person's arm or leg to facilitate the drainage of lymph fluid. An excessive amount of lymphatic fluid can accumulate in one's limb due to trauma to the lymphatic system, creating a condition called lymphedema. This is often seen, for instance, in the case of post-mastectomy patients who have had the lymph system compromised around the treated area. The result is swelling, discomfort, loss of range of motion and activities of daily living. Additionally, the lymph in the affected limb has a very high protein count and can be a potential breeding area for bacteria if the patient's skin is punctured.
There is no viable surgical or pharmacological intervention available to cure lymphedema. The only effective treatment is called Complete Decongestive Physical Therapy (“CDP”). This treatment protocol involves manual lymph massage, bandaging, exercise and education in self-care. The bandaging is intended to create gradient pressure that is highest at the distal area of the limb and which steadily decreases up the limb towards the body. Because it is a goal to drain the limb of all excessive lymph fluid, it is important in the bandaging process to make sure that pockets in the bandages are avoided so that no pools of trapped lymph can be created along the surface of the person's arm.
Self bandaging is time consuming and difficult for the patient to accomplish on his own. There have been several attempts to manufacture a product as a substitute for, or as an adjunct to, self bandaging. Some sleeves comprise an elastic outer shell which snuggly fits against the limb. However, the lymph engorged limb will stretch the outer fabric of the sleeve, therefore defeating its purpose as an effective source of compression. There also exist certain compression sleeves which comprise an inelastic outer sleeve which constrains the swelling of the limb, thus forcing the lymph to drain from the limb back towards the body. Many of these types of devices are intended to be used in conjunction with bandaging wraps and themselves do not provide padding. Needless to say, these types of sleeves can be quite uncomfortable for the patient. There further exists a compression sleeve which provides internal padding having several raised projections. This padding is of a low density type foam and is designed to apply pressure mainly along the points of the projections. The low density foam used in this sleeve is thick and bulky. When worn, it can inhibit flexion of the limb which can lead to discomfort. Further, with this type of sleeve, pooling of lymph fluid can occur at those points in the interstitial area between the raised projections. Accordingly, while lymph flow may be improved, maximum drainage of lymphatic fluid may be precluded. This type of sleeve is useful for prolonged wear, but is not consistent for use with complete decongestive physical therapy where the goal is maximum lymph drainage.
Therefore, there exists the need for a compression sleeve having padding for patient comfort yet having a construction that will aid in providing complete compression to the limb by gradient pressure for maximum drainage of the lymphatic fluid. There further exists the need to provide a compression sleeve that is light in weight and not bulky.
SUMMARY OF THE INVENTION
It is an object of this invention, therefore, to provide a compression sleeve for applying gradient pressure for application to a person's limb in connection with complete decongestive physical therapy to facilitate the drainage of excessive lymphatic fluid from the limb. The compression sleeve of the instant invention is comprised of an inner flexible sheet padding layer and an outer inelastic fabric layer. The inelastic outer layer constricts swelling of the limb which helps promote the flow of lymph out of the limb. A plurality of tightening straps are laterally disposed in vertical succession along an exterior side of the sleeve to independently apply circumferential pressure along the length of the sleeve. This allows the application of a consistent, gradient pressure from a distal part of the limb to its proximal end to help squeeze the excess lymph out of the limb. The inner padding layer is comprised of a high density foam material provided in a thin, continuous surface, flat sheet. The high density foam material comprising the inner padding layer has a high degree of firmness and has a compression factor sufficient to evenly distribute the pressure generated by the circumferential tightening straps. The tightening straps are aligned adjacently in close proximity to each other along the sleeve so that upon application of circumferential pressure by the straps, the padding will not bulge out from between the straps. The inner padding layer is held in place within a pocket formed by a lightweight mesh fabric connected to said inelastic outer layer.
The compression sleeves may be configured for either an arm or a leg. The thin, flat inner foam layer provides less material within the sleeve, thus allowing for a sufficient degree of limb flexion. Further, the sleeve can be formed with a slight angulation approximating the normal degree of limb flexion at rest. As an alternate inner padding layer, a gel sheet may be used. This type of material, while also providing good support, has a high heat flux factor, enabling the patient's limb to remain cool while wearing it on the limb. The gel sheet, with its high heat flux, draws heat from the patient's skin. When the high density foam material is used as an inner padding layer, holes can optionally be placed in the foam so that the patient's skin can breathe and to allow for the release of excess heat.
The leg compression sleeve can be provided with differing density foams bonded or sewn together to help reduce the weight of the sleeve so that it is less likely to slip from the patient's leg due to gravity. Further, one of the foam pads may have a higher degree of rigidity to maintain the elongated sleeve shape.
It is therefore an object of this invention to provide a compression sleeve to facilitate drainage of excessive lymph fluid from a person's limb. It is further an object of this invention to provide such a compression sleeve with a firm, high density foam inner padding layer to evenly distribute the circumferential pressure placed on the limb by the tightening straps. It is still further an object of this invention to provide a compression sleeve having increased breatheability of the inner padding layer as well as a high heat flux factor to increase the patient's comfort.
The above features are objects of this invention. Further objects will appear in the detailed description which follows and will be otherwise apparent to those skilled in the art. For purposes of illustration of this invention, a preferred embodiment is shown and described herein below in the accompanying drawing. It is to be understood that this is for the purpose of example only and that the invention is not limited thereto.
REFERENCES:
patent: 4027666 (1977-06-01), Marx
patent: 4469095 (1984-09-01), Herrera
patent: 4657003 (1987-04-01), Wirtz
patent: 4832010 (1989-05-01), Lerman
patent: 5257956 (1993-11-01), Ewen
patent: 5437621 (1995-08-01), Andrews et al.
patent: 5449341 (1995-09-01), Harris
patent: 5695452 (1997-12-01), Grim et al.
patent: 5735807 (1998-04-01), Cropper
patent: 5743866 (1998-04-01), Bauerfeind et al.
patent: 5916183 (1999-06-01), Reid
Legacy Compression Systems, Aug. 1, 1998 press release.
Brown Michael A.
Greensfelder Hemker & Gale, P.C.
Hamilton Lalita M.
Medassist-OP, Inc.
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