Surgery – Blood drawn and replaced or treated and returned to body
Reexamination Certificate
2000-01-14
2003-08-26
Sykes, Angela D. (Department: 3762)
Surgery
Blood drawn and replaced or treated and returned to body
C604S006090, C604S019000
Reexamination Certificate
active
06610024
ABSTRACT:
This application claims priority to Italian Application Ser. No. M099A000259 filed Nov. 16, 1999, the disclosure of which is incorporated herein by reference. The disclosure of Italian Application Ser. No. M098A000162 is also incorporated herein by reference.
BACKGROUND OF THE INVENTION
The present invention relates to a multipurpose machine for monitoring and control of locoregional therapies in oncology.
Locoregional therapies currently applied in oncology use techniques which provide for the surgical or radiological insertion of special vascular catheters with two or three passages, in order to reach and directly perfuse the tumor or the body region invaded by the neoplasia.
It has in fact been demonstrated that the locoregional administration of antiblastic medicines leads to increased local concentration thereof, with exposure of the carcinogenic cells to more effective pharmacological levels.
In particular, perfusion methods have been recently developed which provide for simultaneous arterial and venous blockage and allow to artificially create localized metabolic situations such as hypoxia, hyperoxia or hyperthermia, all of which are harmful for the tumor and instead extremely useful for boosting the effectiveness of the antineoplastic medicines used.
The best-known and most widely used techniques are the hypoxic perfusion (so-called stop-flow) with subsequent filtration, and the intraperitoneal hyperthermal chemoperfusion (known as IPHC).
Hypoxic perfusion requires, throughout its execution, constant and attentive monitoring and control of the parameters during its main steps, which can be summarized as follows:
perfusion of the organ, after isolating it, with a flow of medicine which can vary between 80 and 120 ml/min according to the systemic pressure of the patient;
infusion of the chemotherapeutic agents according to predefined patterns, sequences and timings, but most of all according to the state of oxygenation of the tissues or of the blood in locoregional circulation;
time-controlled circulation of the chemotherapeutic agent;
filtration of the chemotherapeutic agent in locoregional circulation by using the hemofiltration and/or hemodialysis technique;
filtration of the chemotherapeutic agent in systemic circulation by means of the hemofiltration or hemodialysis technique, with associated control of the fluid balance of the patient.
Intraperitoneal hyperthermal perfusion instead consists in perfusing the peritoneal cavity with a solution which contains chemotherapeutic medicines at a controlled temperature of 42.5° C.
Both the flow of the solution and the duration of the perfusion are established according to preset patterns.
Hyperthermal perfusion can be performed with the abdomen open or closed, after inserting and adequately placing heat sensors, usually at least five, in the intraperitoneal cavity and four catheters which are connected to the perfusion/circulation circuit, in which the flow is controlled by means of a pump of the peristaltic type.
Execution of these therapies has always been entrusted exclusively to the professional experience of physicians and health workers, who have used devices assembled in a makeshift fashion and under their direct responsibility. A further risk exists of forced interruption of the therapy due to interruptions in the public electric main powering these devices at a moment when the chemotherapeutic agents are already perfused into the patient's body at their highest concentration and they cannot be removed any more, which seriously threatens the safety of the patient.
Moreover, in the current state of the art there is no device which allows to perform the above-described intraperitoneal hyperthermal therapy.
Furthermore, conventional devices used by medical staff rely on the constancy of the delivery of mains electric power for their operation.
SUMMARY OF THE INVENTION
The aim of the present invention is to solve the above-described problems of the prior art by providing a multipurpose machine for monitoring and control of locoregional therapies in oncology which allows medical and paramedic staff to perform both hypoxic perfusion and intraperitoneal hyperthermal perfusion therapies with a fully automated procedure and with maximum safety for the patient, with constant control of every physiological parameter involved and which further allows, if necessary, any direct corrective action by medical and paramedic staff.
An object of the present invention is to provide medical and paramedical staff with a multipurpose machine for monitoring and control of locoregional therapies in oncology which has an extremely compact structure, is easy to carry and absolutely reliable in operation even in case of an interruption of the mains electric power supply or in case of technical failure of the pumping means employed, particularly the main one located along the first loop.
This aim, this object and others are all achieved by a multipurpose is machine for monitoring and control of locoregional therapies in oncology, characterized in that it is constituted by a head which has a box-like structure and is supported by a stand which has means for modifying its dimensions, this head being in turn provided with elements for supporting packages of adsorbent means and/or for regulating chemotherapy and chemofiltration.
Conveniently, the multipurpose machine for monitoring and control of locoregional therapies in oncology is characterized in that the head accommodates a first set of duct circuits which forms at least two interactive or separable main loops, a first one for infusing the chemotherapeutic agents and a second one for filtering the chemotherapeutic agents.
Advantageously, the multipurpose machine is also characterized in that the head accommodates a second set of duct circuits which can be activated as an alternative to the first set of duct circuits in order to perform intraperitoneal hyperthermal perfusion therapy.
REFERENCES:
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patent: 5277820 (1994-01-01), Ash
patent: 5494822 (1996-02-01), Sadri
patent: 5722947 (1998-03-01), Jeppsson et al.
patent: 5910252 (1999-06-01), Truitt et al.
Deak Leslie R.
Sykes Angela D.
Wolf Greenfield & Sacks P.C.
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