Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-09-16
2001-12-04
Nguyen, Anhtuan T. (Department: 3734)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S540000, C604S541000, C604S543000, C604S500000, C604S027000, C604S030000, C604S120000
Reexamination Certificate
active
06325788
ABSTRACT:
TECHNICAL FIELD
The present invention relates to the treatment of a wound or joint, with particular applicability to post operative closed muscular skeletal wounds. The invention provides alleviation of pain, while promoting healing of the wound and early rehabilitation.
BACKGROUND OF THE INVENTION
Of major concern in the care of wounds such as incurred in joint surgery are relief of post-operative pain, avoidance of infection, hastening of healing and early joint motion, and decrease in the length of the patient hospital stay. Traditional post-operative management of orthopaedic wounds or traumatic wounds have varied in approach whereby wounds are left open or closed, with or without drains to drain out the debris and blood. Debris and blood are an excellent culture medium which is easily contaminated in dependence upon the wound environment. Accumulation of fluid in the wound causes swelling, pain and delayed healing.
Treatment of pain relief by means of narcotics has drawbacks such as constipation, drowsiness, stasis pneumonitis, itching, vomiting, confusion and ataxia. Problems associated with epidural analgesia include itching, constipation, increased blood loss, severe ataxia and very expensive multiple injections. Thus, the need has existed for new and improved means for management of pain relief and maintenance of a sterile environment.
U.S. Pat. No. 5,616,121, issued to McKay on Apr. 1, 1997, discloses a treatment for alleviating pain in joint wounds through use of irrigation with a medicinal solution. Irrigation lessens the risk of infection and scar tissue that would otherwise occur from accumulated debris and fluid. The patented treatment provides an infusion tubing for infusing a prepared solution into the wound, and a suction tubing for suctioning fluids from the wound. The infusion tubing and suction tubing are joined to communicate with a single tube that is inserted in the wound. Through the use of valves and controlled pump operation, successive timed intervals of infusion and suction, separated by interruption intervals, bathing of the wound is achieved.
Important criteria for use of medical devices in post operative care management are the following. The risk to the health or well being of the patient should be insignificant. Any device that is connected internally to the patient to infuse or subtract fluid should be a closed, sterile system to prevent invasion of environmental contaminants. As patients should be ambulatory as early as possible to prevent deep vein thrombosis, the device should be portable, thereby permitting patient mobility. Mobility also enhances the prospects of early rehabilitation and shortened hospital stay.
While the above described McKay patent meets these criteria, it has been found through the present invention that significant additional improvement is obtainable. The use of separate infusion tubes and suction tubes in the patented method avoids the mixing of the infusion solution and the joint fluids in either of the tubes. The separation of infusion periods and suction periods by interrupted intervals, minimizes such mixing in the single insertion tube. The single insertion tube, however, does have the disadvantage that debris or bacteria remaining therein from a previous suction period may be readministered to the joint during the following infusion period. A further disadvantage is that the pressure in the joint is subject to relatively wide variation over the repeated processes of infusion, interruption and suction. Negative pressure is to be avoided as bacteria can be drawn into the wound along the drain and through the skin.
A desirable practice during surgery and its immediate aftermath is to collect patient blood loss for reinfusion into the body if necessary. Reinfusion of the patient's blood is a preferable alternative to transfusion of blood from an unknown donor. Apparatus for autotransfusion are disclosed, for example, in U.S. Pat. No. 4,443,220, issued to Hauer et al. on Apr. 17, 1984, and in U.S. Pat. No. 5,279,550, issued to Habib et al. on Jan. 18, 1994. For post-operative treatment of joint wounds, patient bleeding occurring during an initial period would be collected, to be followed by an extended period of irrigation treatment, such as the McKay patent approach, or other care management. The entire procedure would involve set up and application of a blood collection device exemplified by the above identified patents, removal of this device, and subsequent application of the McKay patent irrigation system. This procedure has the disadvantages of subjecting the patient to added discomfort in the exchange of medical devices, increased time required to administer the exchange while maintaining a sterile environment, and the expense of the two medical devices necessary to perform both functions.
The need therefore exists for a single medical device, such as that of the McKay patent, that can perform both a blood saving function and a wound irrigation function. Such an apparatus should assure that the collection and saving of blood is accomplished without damage to blood cells.
SUMMARY OF THE INVENTION
The present invention overcomes the aforementioned disadvantages in part by its ability to mimic the normal defense of the human body to invasion by foreign material. The body has a normal tissue tension of 10-15 mm/Hg. A break in the skin will lead to swelling and increased tissue pressure. All wounds leak extra cellular fluid after bleeding has stopped due to the tissue tension, or pressure, that increases with inflammation and swelling. The leaking of cellular fluid in a wound relieves inflammation, swelling and pain in all layers through to the skin, while tending to prevent foreign materials from entering the wound.
An advantage of the present invention is that post-operative joint wound care can be provided with the maintenance of a positive physiological pressure in the wound automatically by appropriate infusion and suction of medicinal fluid to alleviate pain and promote healing.
An additional advantage of the present invention is that a closed wound irrigation system is provided wherein all infusion tubing will transport only infusion solution so that there is no mixing with body fluid or residue removed from the wound. A highly sterile environment thus can be provided and maintained at the wound. A concomitant advantage is that, without the possibility of such mixing, medicated solution can be infused throughout the irrigation period, during which time suction can be intermittently applied. This feature adds the advantage of more a simplified control of the irrigation process than the earlier prior art method.
Yet another advantage of the present invention is that a single device is provided that is capable of performing both a blood collection and saving function and a wound irrigation function following surgery with a minimum of invasive administration.
Another advantage of the present invention is that the system is portable, allowing early mobility, of particular importance to patients recovering from surgery at leg joints.
These and other advantages are satisfied, at least in part, by the provision of an apparatus for treating a body joint wound subsequent to surgical intervention. An infusion tube is insertable into the wound for transporting a prepared solution to the joint. The prepared solution may contain prescribed amounts of local anesthetic, anti-inflammatory, anti-coagulant and antibiotics. A second tube is insertable into the wound for transport of fluid removed from the joint. The latter tube has perforations along the portion that is to be inserted in the wound to aid entry of the body fluids. A vacuum device is coupled to the second tube. Suction is automatically turned on to evacuate the wound for a prescribed period of time and then stopped for another prescribed period of time. The on and off cycle can be repeated, for example, over a twenty four to seventy two hour period. During the entire period, the prepared solution is constantly infused. The infusion tube and evacuation tu
Maynard Jennifer
McDermott & Will & Emery
Nguyen Anhtuan T.
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