Surgery – Miscellaneous – Methods
Reexamination Certificate
1999-01-14
2001-03-06
Nguyen, Dinh X. (Department: 3738)
Surgery
Miscellaneous
Methods
C606S201000
Reexamination Certificate
active
06196231
ABSTRACT:
BACKGROUND OF THE INVENTION
Lymphedema is the accumulation of excessive lymph fluid and swelling of subcutaneous tissues due to the obstruction or destruction of lymph vessels. In breast cancer patients, lymphedema occurs in the arm and results in painful swelling. Excessive fluid accumulation, referred to as edema, can also arise in the arms, legs and, trunk from a variety of other causes, including infection, radiation therapy, and other conditions which result in damage to or destruction of portions of the lymphatic and/or venous system.
Sleeve devices have been previously used to apply pressure at various locations along the length of an arm, for example, to relieve swelling due to lymphedema and other causes. Such sleeves have a plurality of laterally extending strap elements which can be tightened to exert pressure points or lines against the skin to permit the release and flow back of fluid to the remaining healthy lymph nodes. Such a device and method of use are disclosed in co-pending application U.S. application Ser. No. 08/390,866. While such devices are effective, they incur some difficulty in use because they provide no way to measure the hardness or softness of the arm, and they provide no way of determining how much pressure should be or is applied to the limb being treated. One of the problems in this area of medicine is to measure how soft or hard the arm is. Is there a lot of fluid that is easily displaced, or is the tissue hard and fibrotic? Understanding this helps us guide therapy. Different treatments are used if the tissue is soft or hard. The soft, fluid filled edema is called pitting edema. In pitting edema, application of pressure with a finger, for example, will cause the fluid to move away from the area where the pressure is applied and will leave an impression of the finger, or a pit. After the pressure is removed, the impression of the finger will remain for some time. In other conditions there is no pitting, the tissue is hard and fibrotic and no pit is left in the skin after the application of pressure with a finger.
It is therefore a principal object of this invention to provide a method of determining the hardness or softness of the limb being treated.
A further object of the invention is to provide a method of determining the amount of pressure to be applied to the limb being treated.
A still further object of this invention is to provide a sleeve apparatus that will permit predetermined pressure to be applied to spaced apart areas of the limb being treated.
These and other objects will be apparent to those skilled in the art.
SUMMARY OF THE INVENTION
A limb sleeve is provided which has an elongated open seam with a plurality of laterally extending pressure straps extending therearound. The sleeve has a girth that will encircle the limb being treated. Such a sleeve is disclosed in said co-pending U.S. application 08/390,866. The pressure straps have removable indicia patches thereon to permit the operator to tighten each strap sufficiently to exert a predetermined amount of pressure on the arm as permitted by the method of this invention.
The method of this invention is employed after the attending physician decides the magnitude of the pressure to be applied to limb based upon several factors including the limb tissue of a specific patient, the degree of swelling, and possibly other factors. Typically, the applied pressure is within the range of 15-45 mm of mercury. The physician will then take a device very similar to a conventional blood pressure measuring device which includes an elongated flexible hollow inflatable bladder, an elongated flexible tube having one end in communication with the interior of the bladder, and an opposite end secured to an air pump bladder and a pressure recording device having a visible pressure indicia dial.
The bladder is placed within the space between a pair of stationary platens, and the bladder is precharged with a quantity of air to measure, for example, 10 mm of mercury. The bladder is then removed from the platens, whereupon the pressure indicia dial will return to a zero reading.
The limb of the patient is then inserted in the pressure sleeve, and the pressure straps are randomly affixed. Then, one by one, the pressure straps are released, and the bladder is inserted through the partially opened seam under the released strap. The released strap is then closed and tightened against the bladder to compress the bladder sufficiently to the desired pressure against the limb. Thus, if it was desired to exert pressure in the amount of 30 mm of mercury against the arm, the strap would be tightened until the needle on the pressure recording device moved to the numeral “30”. A detachable indicia marker would then be attached to the strap adjacent the tightening buckle to let the operator know the degree to which the strap should be tightened to achieve 30 mm of pressure against the arm. With the indicia marker in place, the strap is loosened, the bladder is removed from the sleeve, and the strap is then again tightened to its previous position indicated by the indicia marker. These steps are then repeated for each pressure strap on the sleeve.
The knowledge of the hardness or softness of the patient's limb is helpful in guiding the therapy of the patient, either in conjunction with the foregoing process or in other therapeutic procedures. To determine the hardness or softness of the limb tissues, the bladder is filled with a fixed, small amount of air and placed on the arm and then compressed. If the pressure of the bladder causes fluid to move, the bladder will expand, and the pressure in the bladder will fall. The rate and degree of pressure change in the bladder is determined by the gauge connected to the bladder. As in the case of the finger causing pitting, the bladder will cause pitting in the edematous arm. The pressure in the bladder is then monitored at intervals to assess tissue changes.
REFERENCES:
patent: 1629108 (1927-05-01), Lake
patent: 3856008 (1974-12-01), Fowler et al.
patent: 3888242 (1975-06-01), Harris et al.
patent: 4150442 (1979-04-01), Boone
patent: 4186738 (1980-02-01), Schleicher et al.
patent: 4338923 (1982-07-01), Gelfer et al.
patent: 4369588 (1983-01-01), Berguer
patent: 4383342 (1983-05-01), Forster
patent: 4421110 (1983-12-01), DeLisle et al.
patent: 4573456 (1986-03-01), Spann
patent: 4971041 (1990-11-01), Millikan et al.
patent: 5007411 (1991-04-01), Dye
patent: 5179941 (1993-01-01), Siemssen et al.
patent: 5218954 (1993-06-01), Van Bemmelen
patent: 5383842 (1995-01-01), Bertini
patent: 5383894 (1995-01-01), Dye
patent: 5591200 (1997-01-01), Cone et al.
Nguyen Dinh X.
Zarley McKee Thomte Voorhees & Sease
LandOfFree
Method for treating limb swelling disorders and the like does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Method for treating limb swelling disorders and the like, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Method for treating limb swelling disorders and the like will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2496640