Measuring article and method for sizing compression garments

Geometrical instruments – Distance measuring – By flexible tape

Reexamination Certificate

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C033S512000, C033S679100, C033S759000

Reexamination Certificate

active

06415525

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to the patient sizing of compression garments for wound sites used during postoperative recovery, and more particularly, to a measuring strip article and method for sizing such garments on patients.
BACKGROUND OF THE INVENTION
Medical procedures such as plastic, aesthetic, reconstructive, and like surgeries, and injuries such as burns, generally result in one or more wound areas on the operated upon or injured body part or parts. Wound and injury healing is a complex science affected by many inter-related body functions. Arterial and venous blood flows, lymphatic drainage and body temperature are three key factors in the reduction of the time for a wound or injury to heal without complications. Such complications can include edema, seroma, hematoma, and infection, to name a few, which inhibit proper wound healing and are sometimes life-threatening. Current post-operative procedures and devices used by medical professionals do not consider the simultaneous interaction of the above-mentioned blood flows, lymphatic drainage and maintenance of body temperature with wound or injury healing.
Arterial and venous blood flows are intricately related and regulated by the body. Flow pressure ranges are important and remain within certain parameters; changes to them can greatly affect body function as well as wound healing. Arterial pressures normally remain with 120 mm Hg (systolic) and 80 mm Hg (diastolic) and, due to the muscular nature and structure of the body's arterial delivery system, remain relatively constant. On the other hand, venous pressures are more variable because veins are oftentimes compressed and consequently impede blood flow back to the heart. The central venous pressure is normally about 0 mm Hg while the venous resistance and the effect of hydrostatic pressure can vary the venous pressure up to about 100 mm Hg or more.
Key then to the continuous flow of arterial and venous blood flows is the venous pump. The veins are constantly being squeezed and compressed by the body's muscles and other external pressures. It is important to note that the function of the venous system is extremely important to the circulatory filling pressure, an important determinant of cardiac output. The slightest improvement of venous tone and venous filling ultimately will positively affect cardiac output, which can be correlated to as an important factor to improved wound healing. External compression garments are commonly prescribed as an aid to a reduction in venous flows such as varicose veins.
The lymph system is an accessory route used by the body to maintain fluid balance between the interstitial spaces and the blood. Most of the fluid escaping from the capillaries is reabsorbed into the venous capillaries but the remaining 10%, or so, is key both to life function and wound healing. The lymph system, with this small amount of fluid, can also carry proteins and particulate matter away from tissue spaces (i.e., a wound site) that would not normally be removed by capillary action. The action of this function of the large vessel lymph system is called the lymphatic pump and is an intricate, fine functioning system of major lymph vessels and valves. Key to this is that the large lymph vessels can be compressed by the walls of the lymphatics themselves or by additional pressures from the surrounding surfaces. This same function in the large vessels occurs in the lymph capillaries.
During the normal postoperative period, the patient is restricted from activity, and is sometimes confined to a bed. This quiet period is contraindicated for the lymphatic pump action as there are no external factors to increase lymphatic flow during a time that the body most likely has need of such flow, for example, to reduce the occurrence of edema, seroma, hematoma and other complications. An externally applied compression would be helpful and advantageous to promote the beneficial lymphatic flow.
As mentioned above, the removal of proteins from the interstitial fluid has an important balancing effect. Proteins, in other than proper amounts, can affect tissue colloid osmotic pressures, which can affect capillary fluid absorption and interstitial fluid volumes and pressures. Interstitial fluid pressures are normally negative and are maintained this way by a proper functioning lymphatic pump but even more so by the removal of excess proteins. The area around the postoperative wound site has been most likely traumatized by a number of factors and thus the proper functioning if the wound site has been reduced. External compression can aid the body and more specifically lymphatic flows to maintain protein balances by maintaining the normal “dry” state of the interstitial spaces.
Common postoperative complications directly relating to interstitial fluid spaces include edema, seroma and hematoma, as noted hereinabove. Many factors can cause the interstitial pressures to increase and without a similar increase in fluid flows, there is a fluid buildup or edema. A stretch of the tissue spaces occurs with edemas of more than a few days, sometimes even a few hours, so proper and immediate treatment is important. Further to the stretch of the tissue is the fact that this excess fluid disrupts the normal absorption and use of tissue nutrients as the cells are now further from the capillaries. In the case of a wound site, this will slow the recuperative capacities of the body to heal the wound. Seromas can also affect the wound or injury site as does edema but, additionally, the danger of infection is increased. A hematoma similarly affects the wound site.
It should also be noted that arterial, venous and lymphatic pressures and flows are intricately balanced and interrelated. Additionally, the interstitial fluid volume and pressures are also balanced with these systems. The skin acts as the body's normal enclosure and it has its own elastic characteristics. Injury or wounds may disrupt the normal fluid and pressure balances causing fluids to build up and the skin stretches or contracts depending on the time from injury.
It is possible to proactively address the possibility of complications by applying external pressure immediately postoperatively with the intent of increasing capillary pressures and lymphatic flows, with a target range of about 17 to 32 mm Hg above the normal capillary pressure. This can be done with a properly designed, sized and applied compression garment.
Compression garments such as elastic bandages, dressings, girdles, vests, facial bandages, arm bandages, surgical bras, briefs, body suits, gloves, leg bandages, and trunk bandages are commonly used in the treatment of these cases with generally favorable results. However, there are well-known cases of the use of such articles that due to their design, material composition, sizing or application actually worsened the patient condition and caused complications. The correct application of compression is critical to enable the garment to perform within the intricate requirements of the body's systems as described hereinabove. A garment that is properly sized and applied performs as good or better than skin in stretch, compression, and thermoregulation, and is greatly beneficial in promoting proper and rapid healing in the patient's postoperative regime.
Compression garments are typically made and sold in a fixed range of sizes, unless custom-made garments are required. Accurately fitting the user with a garment that is the correct size, to thereby provide the desired compression, elasticity, and moisture absorption, is problematic when exact measurements are requested. Typically, to size a compression garment, an attendant must precisely measure a body part in inches or centimeters, make a notation of the measurement, look up the measurement in a conversion chart to determine the appropriate garment size such as small, medium, large, etc., and finally, order the proper size garment from an inventory.
The possibility of human error is thus introduced into the process

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