Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1997-04-24
2001-02-13
Mendez, Manual (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S030000
Reexamination Certificate
active
06186977
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the field of medical devices and procedures, and, more particularly, to an apparatus and related methods for administering anesthesia.
BACKGROUND OF THE INVENTION
There is a continuing trend in health care to significantly reduce and replace in-patient hospital care with ambulatory care. For example, ambulatory surgery now accounts for over 60% of all operations performed in the United States, and is expected to increase to 80% of all procedures by the year 2000. This trend is likely to continue as surgeons embrace the ongoing development of minimally invasive surgical techniques, as third party payers reduce or restrict payments for health care, and as the acceptance by patients and society grows for ambulatory care.
The traditional delivery of anesthesia for in-patient hospital care typically relies heavily on the use of inhalation anesthesia agents. For example, the Excel series anesthesia systems from Ohmeda include a hypoxic guard, sophisticated electronic ventilation, flow management systems, vaporization and breathing circuits. The systems offer a choice of monitors, vaporizers, ventilators, and offer drawers or shelves for storage. Unfortunately, the bulkiness of even advanced conventional inhalation equipment severely hinders the portability of the equipment and thereby limits the possible locations where the equipment may be used.
Another significant shortcoming for traditional inhalation anesthesia systems is that scavenging or ventilation systems are required by various governmental regulations, such as OSHA regulations in the United States. In other terms, complicated and expensive room ventilation as in a traditional operating theater is needed for conventional inhalation systems to comply with various regulations.
As reported in the March 1997 issue of Anesthesiology News, “[t]he transition from the hospital to the free-standing surgical center to the office surgical suite continues to escalate.” Accordingly, the ambulatory trend in health care creates new geographic sites that may be desirably served by an unburdened anesthesia delivery system.
There are several anesthesia techniques which do not necessarily require the use of vaporized inhalants. Total intravenous infusion anesthesia (TIVA) uses liquid intravenous agents in place of the conventional vaporized inhalants. Along these lines, target controlled infusion (TCI) is a way of administering an intravenous anesthesia agent using a computer to monitor the patient and control an infusion pump. Using a computer with a pharmacokinetic program permits control of a desired plasma concentration of an agent, such as propofol, without overshooting the desired level.
Unfortunately, conventional intravenous agents for TIVA or TCI may have relatively long offset times, that is, relatively long times before the anesthesia and other effects wear off in the patient. Some agents may result in active metabolites that additionally remain for a relatively long time after stopping delivery of the anesthesia. Moreover, a quick onset and quick offset analgesia agent has not been previously available. In view of the prior shortcomings of conventional TIVA agents, there has been no incentive to develop efficient integrated platforms for using TIVA or TCI in an ambulatory setting.
SUMMARY OF THE INVENTION
In view of the foregoing background, it is therefore an object of the present invention to provide an apparatus and associated methods for delivering total intravenous anesthesia to a patient, such as in an ambulatory setting.
It is another object of the present invention to provide a compact and efficient integrated apparatus and associated methods for delivering total intravenous anesthesia to a patient and while providing monitoring of important patient characteristics.
These and other objects, advantages, and features of the present invention are provided by an apparatus for total intravenous anesthesia which comprises at least one supply and delivery means for an intravenous anesthesia agent carried by the apparatus housing, and at least one monitor for monitoring a characteristic of the patient. Moreover, the at least one intravenous anesthesia agent preferably includes a first intravenous anesthesia agent having a relatively quick offset so that the effects thereof wear off relatively quickly upon stopping the intravenous infusion. Intravenous infusion of the at least one anesthetic agent results in total intravenous anesthesia in the patient and without using an inhaled anesthesia agent.
For monitoring the patient, the apparatus preferably includes one or more monitors carried by the apparatus housing for monitoring patient characteristics. The monitors may include one or more of an electrocardiogram, a blood oxygen monitor, a blood carbon dioxide monitor, an inspiration oxygen monitor, an expiration oxygen monitor, an inspiration carbon dioxide monitor, an expiration carbon dioxide monitor, a blood pressure monitor, a pulse rate monitor, a respiration rate monitor, and a patient temperature monitor, for example. Any of these monitors, or combinations of monitors may be included in the relatively compact housing of the apparatus. In addition, the apparatus may also include at least one recorder cooperating with the monitors to provide a record of a respective monitored patient characteristics.
Also relating in part to monitoring, the apparatus may also preferably include telecommunication means carried by the housing to be available for providing a telemetry and/or voice communications channel to another site. The telecommunications means may include a wireless transceiver, such as a transceiver for cellular telephone communications.
The apparatus also preferably includes a back-up battery power supply carried by the housing so that the apparatus is operable in the event of a power outage. The housing also desirably has an upper surface defining a horizontal work surface. In addition, wheels or castors may be provided on the housing of the apparatus to increase its portability. A storage cabinet may also be associated with the housing of the apparatus for storing consumables used for total intravenous anesthesia.
Returning again to the first anesthesia agent, the first relatively quick offset anesthesia agent is preferably a quick onset and quick offset analgesia agent. The relatively quick offset is preferably defined by a relatively short biological half-life not greater than about 10 minutes. For example, the first intravenous anesthesia agent may comprises an esterase metabolized opioid, such as remifentanil. A second supply of a second intravenous anesthesia agent carried by the housing may also be included. The second supply may be another anesthesia agent, such as the amnestic propofol, for example.
A method aspect of the invention is for administering total intravenous anesthesia to a patient. The method preferably comprises the step of providing a housing carrying at least one supply of an intravenous anesthesia agent, at least one infusion pump for delivering the intravenous anesthesia agent, and at least one patient characteristic monitor. The method also preferably includes the step of controllably intravenously delivering the intravenous anesthesia agent to the patient from the supply carried by the housing and using the infusion pump also carried by the housing so that total intravenous anesthesia is achieved in the patient.
Moreover, the at least one intravenous anesthesia agent is preferably provided by a first intravenous analgesic having a relatively quick offset so that effects wear off relatively quickly upon stopping intravenous infusion. The method also preferably includes the step of monitoring at least one patient characteristic using the associated patient characteristic monitor carried by the housing during administration of total intravenous anesthesia. For example, the step of monitoring may include monitoring one or more of the patient's heart activity, blood oxygen level, carbon dioxide blood level, blood pressure, pulse
Andrews Thomas W.
Guzzi Louis M.
Hartson David P.
Riley James L.
Allen Dyer Doppelt Milbrath & Gilchrist, P.A.
Joseph L. Riley Anesthesia Associates
Mendez Manual
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