Fabric having improved elasticity, modules and...

Textiles: weaving – Fabrics – Drier felts

Reexamination Certificate

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C066S195000

Reexamination Certificate

active

06223782

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to postoperative wound site and injury recovery garments and more particularly to garments made of a polyester fiber material and an elastic fiber material, using a fabric structure having improved elasticity, compression, breathability and thermoregulation characteristics. These characteristics of the fabric, in addition to the high degree of comfort that may also be provided by garments made of the fabric, make it well suited for many other garment applications such as a variety of types of athletic garments.
BACKGROUND OF THE ART
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 of the key factors in the reduction of the time for a wound or injury to heal without complications. Such complications can be life-threatening as well as inhibiting proper wound healing and include edema, seroma, hematoma, and infection, to name a few. Medical professionals address several of these factors with current procedures, but the current art neglects the simultaneous interaction of the previous 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, remains 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 0 mm Hg while the venous resistance and the effect of hydrostatic pressure can vary the venous pressure up to 90-100 mm Hg. 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 significantly 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 have been prescribed as an aid to a reduction in venous flows such as varicose veins and it is a known treatment.
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% 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. Note that 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 is no additional external factors to increase lymphatic flow during a time that the body most likely has need of such (edema, seroma, hematoma and other complications). An externally applied compression would be helpful and advantageous.
Although mentioned briefly above, the removal of proteins from the interstitial fluid spaces is 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.
Some common postoperative complications directly relating to interstitial fluid spaces are edema, seroma and hematoma. Many factors can cause the interstitial pressures to increase and without a similar increase in fluid flows, then 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 that 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. However, it is possible to proactively address the possibility of edemas, seromas, and hematomas by applying external pressure immediately postoperatively with the intent of increasing capillary pressures and lymphatic flows possibly with a target of 17 mm Hg above the normal capillary pressure. This can be done with a properly designed compression garment.
It should 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. Elastic bandaging has been used for many years as an indication in some of these cases, but not widely so as there are well-known cases of the application of conventional elastic bandages or other dressings that due to their design, material composition or application actually worsened the patient condition and caused complications. The correct application of compression is critical and should be able to perform within the intricate requirements of the body's systems. A fabric that could perform as good or better than skin, in stretch, compression, and thermoregulation, would be a great asset to the patient's postoperative regime.
Blood flows are directly affected by the body's autonomic response to maintain the body's core temperature of 37° C. within about 0.6° C. Core body temperature varies depending on external and internal influences, but is much more stable than the body's surface temperature. Heat is produced continually by the body during its metabolic processes and this heat is naturally lost to the surroundings through various mechanisms, principally radiation, conduction, evaporation and air convection. These processes are dynamic and inter-related. The skin is the key organ that is used by the body to maintain temperature and blood flow to the skin's venous plexus and can be up to 30% of cardiac output. Circulation of the skin has two main (and sometimes conflicting functions): 1) nutrition of the skin and 2) conduction of body heat. The rate of blood flow through the skin is the

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