Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Thermal applicators
Reexamination Certificate
1997-08-13
2001-01-23
Graham, Mark S. (Department: 3711)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Thermal applicators
Reexamination Certificate
active
06176870
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to inflatable thermal blankets used in a medical setting to deliver a bath of a thermally-controlled gaseous medium, such as warmed air, to a patient in order to control the patient's body temperature. More particularly, the invention pertains to inflatable thermal blankets to control patient body temperature during a medical procedure while providing access through the inflated blanket for medical personnel. Still more particularly, the invention is directed to inflatable thermal blankets for use with patients receiving medical care in the lithotomy position.
2. Description of the Related Art
The inflatable thermal blanket prior art is best expressed in prior U.S. Pat. No. 4,572,188 entitled “AIRFLOW COVER FOR CONTROLLING BODY TEMPERATURE,” and prior U.S. Pat. No. 5,405,371 entitled “THERMAL BLANKET”. In these patents, an inflatable airflow cover (i.e., inflatable thermal blanket) is inflated by the introduction into the cover of a thermally-controlled inflating medium, such as warmed air. Holes on the underside of the inflatable thermal blanket exhaust the thermally-controlled inflating medium from inside the blanket when the blanket is placed over a patient and inflated, thereby creating an ambient environment about the patient, the thermal characteristics of which are determined by the temperature of the inflating medium. These holes open through the lower blanket surface into the blanket. The inflatable thermal blanket is intended, among other things, for the treatment of hypothermia, as might occur operatively or postoperatively.
Evaluation of inflatable thermal blankets by skilled practitioners has resulted in general approbation: the opinion is that the inflatable thermal blanket efficiently and effectively accomplishes its purpose of giving a thermally-controlled bath, and is highly effective in treating hypothermic patients. However, while the prior art inflatable thermal blanket achieves its objectives, certain improvements to it are necessary in order to realize additional clinical objectives and to enjoy further advantages in its use.
For example, one use for an inflatable thermal blanket is patient temperature control during a medical procedure, such as surgery. The patient's temperature is controlled by distributing the temperature controlled air over the patient's body. But the typical inflatable thermal blanket covers the patient's entire body and it is not possible to simultaneously access the patient, for medical purposes, while the blanket lays upon the patient and is providing temperature regulation.
The difficulty in providing patient access through an inflatable thermal blanket utilizing super atmospheric temperature controlled air is that the openings formed in the blanket necessary to provide patient access permit the temperature regulated air to escape, and such access interferes with the thermal regulation desired to be achieved by the blanket. Contamination of the procedure site because of the escaping air is also a concern.
In some medical procedures, a patient is placed in a lithotomy position. In the lithotomy position, the patient is laying on his or her back while the patient's legs are bent at the knees and extend beyond the end of the operating table. The legs are supported by “stirrups” which provide support at the knees and feet. The lithotomy position is commonly used for procedures or surgery involving the genitals or rectum, such as, for example, vaginal delivery, vaginal hysterectomy, cystoscopy (viewing the bladder with a scope), TURP—transurethral resection of the prostate, hemorrhoid and rectal surgery, nephrolithotomy (kidney stone removal) and ureteral stint placement. In the lithotomy position, the doctor is positioned between the patient's legs, having convenient access to the patient's perineal region, genitals and rectum.
Patients lose a great amount of body heat in the lithotomy position because their legs are suspended in the air and are minimally insulated. Further, some of the procedures done in this position, e.g., TURP, require the use of large volumes of irrigating fluids which also cool the patient. Moreover, many patients needing prostate surgery are older, and are therefore quite susceptible to hypothermia. It is well known in the inflatable thermal blanket art that the efficiency of heat transfer to the patient is proportional to the amount of body surface area covered by the blanket or warm air bath.
Accordingly, a need exits for an inflatable thermal blanket which is capable of delivering a temperature controlled airflow to a patient in order to maintain the patient's body temperature at a desired level while simultaneously allowing access to the patient during a medical procedure. A particular need exists for an inflatable thermal blanket that can be used with patients undergoing medical procedures while in the lithotomy position. What is required is a blanket which allows unimpaired medical access to a patient in the lithotomy position, without jeopardizing the patient's health or comfort as a result of inability to effectively control the patient's body temperature.
SUMMARY OF THE INVENTION
The invention is an inflatable thermal blanket for controlling a patient's temperature, while the patient is in the lithotomy position. The inflatable thermal blanket is formed as an inflatable covering with top and bottom surfaces, and having apertures that pass through the bottom surface to allow air within the inflatable covering to flow out of the covering. An air inlet is placed in the blanket, preferably toward an end closest to the head of the patient. The end of the inflatable thermal blanket that covers and warms the legs of the patient has two elongate inflatable portions. These elongate inflatable portions of the blanket define an elongate recess having a longitudinal dimension extending between the elongate inflatable portions which allows a care giver to have convenient access to the patient's perineal region, genitals and rectum. A pair of uninflatable drape sections may be provided on the inner sides of the elongate inflatable portions to maintain the temperature controlled medium proximate to the legs and lower body of the patient and away from the care site. A pair of uninflatable drape sections may be provided on the end of the blanket closest to the head of the patient to retain the temperature controlled medium near the neck and upper body of the patient.
In a related aspect of the invention, alcoves may be provided along the edges of the elongate inflatable portions and the uninflatable drapes to allow the inflatable thermal blanket to be more easily shaped to the contour of the underside of the patient's legs, when the patient is placed in the lithotomy position. Ideally, the alcoves are wedge shaped. Attachment devices positioned on the elongate inflatable portions and the uninflatable drape sections allow the blanket to be semi-permanently secured in a contoured position to the patient's legs.
In a further related aspect of the invention, the recess may have a transverse dimension at one end of the elongate inflatable portions of the blanket to facilitate maximum surgical access, and to allow for the blanket to be temporarily sealed to the patient by an attachment device, in order to prevent the temperature controlled medium flowing from the blanket into the perineal region, or onto a medical practitioner, during a medical procedure.
In a still further aspect of the invention, a bottom surface of the inflatable thermal blanket is an undersheet of flexible fibrous material, woven or non-woven, that is bonded to a sheet of non-fibrous material, such as plastic. The fibrous material of the undersheet provides greater comfort to the patient because it comes into contact with the patient's skin.
In the operation of preferred embodiments of the invention, a heater/blower that includes a compressor and a heater supplies heated air, under pressure, t
Augustine Medical, Inc.
Graham Mark S.
Gray Cary Ware & Freidenrich
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