Kit assembly for complete wound treatment

Surgery – Means for introducing or removing material from body for... – Treating material applied to or removed from external...

Reexamination Certificate

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C604S289000, C604S023000, C128S202120

Reexamination Certificate

active

06562013

ABSTRACT:

PRIOR ART
Wound management is a significant portion of all medical practice today. Wounds typically occur from a bum, a contaminated trauma (blunt trauma), chronic ulceration, tendon laceration, abscess cavity to be drained, cellulitus (skin irritation), open bone fracture (compound fracture), and pressure sores. Such wounds and their treatment constitute a large percentage of the treatment provided to medical patients. The best treatment or these wounds is complete as possible a cleansing and sterile treatment of them, as close to the time and site of injury, as possible.
The number of methods for wound cleansing and debridement have been developed over the past years. Those methods have been included wound cleansers such as povidone-iodine, hydrogen-peroxide, acetic acid, and chlorinated solutions, which however, have a cytotoxic effect on cells. Other types of wound cleaning and debridement include piston type syringe irrigation, whirlpool treatments, wet to dry saline gauze dressings, surgical/mechanical debridement, enzymatic debridement, absorbent dextranomor microbeads, and pulsed lavage.
Syringe irrigation is sufficient for cleaning most simple wounds. Large complicated wounds, however, require large quantities of irrigant for effective cleansing and debridement. Whirlpool treatments are often utilized for cleansing larger wounds and appear to be common in physical therapy departments. However, with certain deep wounds flushing and debridement is difficult to achieve. The patient must often be uncomfortably positioned in order to direct jets at the wound. If a patient is incontinent, or if multiple wounds are present, cross contamination between those multiple wounds may occur. Wet to dry saline gauze dressings are simple to use and are inexpensive for the patient, but in removal of that dressing they may also damage healthy tissue and may be painful. Such dressing changes may also be a labor intensive procedure. Also, wound care products which are applied as a viscous gel or alginate will require mechanical debridement of the gel between treatments. A complete system to minimize associated risk, to provide such tissue debridement and cleansing treatment at a hospital, field site or home, to a wound of a patient, is badly needed.
A relatively new procedure in wound management is includes pulsed lavage wherein a pulsating water jet is directed toward the wound site, which method is fairly effective in removing debris, bacteria or viscous gel type dressings from those wounds.
Pulse lavage irrigation devices typically utilize a cone shaped shield, having an open base which is placed over the wound. The shield is utilized to minimize splashing to protect the health care worker and to prevent aerosolization of body fluid. Typically a pan would be held against a lower portion of the skin of a patient being treated. A suction tube may be hung into the pan so as to drain out fluid. The fluid is typically saline or saline with an antibiotic added for wound debridement and sterilization.
A number of such physical devices are shown in the prior art to isolate and permit treatment of certain wound sites. One such device is shown in U.S. Pat. No. 5,447,504 to Baker et al. showing a misting apparatus which comprises a container secured to a limb of a patient at each end, by a rigid cuff. The cuff is held onto the limb by a securement strap and each cuff has an opening to permit an elongated listing tool to be fixedly arranged thereto. This apparatus may be satisfactory for applying a mist to a limb, for the prevention of that limb from drying out, but it has rigid conduits which puts limitations on the manipulability of the device which prevents it from applying a wide range of debriding and cleansing actions. U.S. Pat. No. 3,867,929 to Joyner et al. shows an ultrasonic treatment device in which an acoustically transparent container is wrapped around the limb containing a wound site. The container had ultrasonic transducers spaced therearound for generating acoustic vibrations through a fluid within the container and onto the wound site. This however does not provide the flushing necessary of many wound examples.
A further means for treating surface wounds is shown in U.S. Pat. No. 3,228,140 to McCarthy. This device includes cup-like housings which are placed against the wound site to permit containment of the spray from a nozzle and drainage therefrom as well.
Other interesting limb treatment devices are shown in U.S. Pat. Nos. 3,094,983 to Macleod, 2,113,253 to Gray, and 1,105,365 to McQuhae each showing an unusual containment for a limb to permit bathing or improve blood circulation therewithin. Each of these devices, however, are unduly complicated and are not conducive to efficient personalized and adaptive treatment either at hospital bedside without transportation to the physical therapy department, or at home or in the field on the wound of the patient. The prior art requires that the patients wound's conform to the apparatus, and not vice-versa. None of these teach the ability of a treatment kit for wound treatment to effect a complete “whirlpool-bath” type wound treatment, either in a patient's home or in a hospital, so as to otherwise eliminate the risk of transporting a patient to physical therapy or risk lifting the patient into a whirlpool bath, and certainly no provision for use in the field with similar treatment therapies.
It is thus an object of the present invention, to overcome the shortcomings of the prior art.
It is further object of the present invention to provide a complete, portable wound treatment kit apparatus which may be utilized in a medical facility, in a home, or in a field environment which kit apparatus is adaptable to a broad array of wound sites, and, which kit apparatus also permits the protection the operator as well as the patient being treated.
It is yet further object of the present invention, to provide a wound treatment kit apparatus which prevents cross contamination of a wound site from outside the environment or from other wound sites on that patient, and minimizes the likelihood of contamination from that patient to a further patient.
BRIEF SUMMARY OF THE INVENTION
The present invention comprises a kit apparatus for the washing and debridement of wounds on limbs and body portions of patients. Such a kit arrangement is anticipated to be used both in and outside a formal medical facility, such as for the use in a home or the field. This kit permits the replacement or minimization of the risk associated with the use of a whirlpool bath, to eliminate cross-contamination of body fluids, and to minimize the spread of bacteria, hepatitis, and other strep and pathogenic organisms. The kit arrangement of the present invention includes a plurality of bag-like flexible envelopes of transparent plastic material having a first primary opening for the receipt of a body limb or for the attachment to a body portion having a wound site thereon. The envelope will include at least one secondary opening having a flexible annular support collar therearound for insertion of a fluid delivery device. The flexible envelope will have at least one tertiary port for the drainage and withdrawal of fluid, washed away tissue, and for the release of pressurized gas which has been delivered into the envelope.
The kit arrangement includes a hand-held, reusable, manipulable gun for the delivery of a pressurized fluid. The fluid may be a gas and or a liquid mixture. The hand manipulable gun has a trigger mechanism to permit the regulation of the flow of fluid and of gas therefrom.
The kit also preferably contains a plurality of hollow, elongated tube-like wands, having a first end and a second end. The first end of each wand is insertable into a receiving orifice on the hand manipulable gun, and the second end of each wand having a nozzle attachment thereon. The nozzle attachment may include various angled nozzles, a brush, a sponge, or a medicament applicator. The kit also preferably includes a plurality of lengths of tubing to conduct gas or fluid from a res

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