MXPA97008299A - Rap infusion system - Google Patents

Abstract

A rapid infusion system for rapidly supplying blood and / or volume expander fluid to a patient, including a permanent portion and a removable portion, wherein the permanent portion includes adjustable directional means, and the removable portion includes subcomponents that are placed in contact with the sang

Description

FAST INFUSION SYSTEM FIELD OF THE INVENTION This invention relates to an apparatus for the rapid infusion of circulatory support fluids such as blood in patients. The system comprises permanent components. The various components that physically come into contact with the fluid that has been infused can be easily removed and sterilized. The main advantage of this arrangement lies in the fact that it is very small, light and portable. The system can be of a size that fits well in the person's hand and is ideal for use by emergency personnel. BACKGROUND OF THE INVENTION During surgery in the emergency room, it is often necessary to infuse blood or fluid that rapidly expands the volume in a patient, particularly when massive blood loss has occurred. Patients with an inadequate volume of blood can suffer serious consequences. There are many situations where large amounts of blood can be lost in a very short period of time, for example, in the case of serious car accidents, gunshot wounds in critical areas of the body and a variety of major surgeries that include surgeries. cancer and heart and in liver transplants. In the past, replacing large amounts of lost blood has been a major problem for surgical teams that treat a patient's suffering. A common infusion method includes the use of a plurality of simultaneous infusion sites. The infusion bags or bags of the stored blood bank are interconnected by means of an intravenous tube. Frequently, a plurality of medical personnel are required to examine the various infusion sites and to personally ensure the flow of blood from the blood bag. Anesthetists are regularly involved with cardiopulmonary resuscitation, trauma and organ transplant procedures, and with maintaining the patient's bodily functions during trauma and organ transplant operations. During the trauma and operations of organ transplants, the patient can not lose blood, practically speaking, it will be contained by the operating surgeon and must be replaced by the anesthesiologist established in service. This is not very common for four or five anesthetists or technicians to establish a service during transplant operations that last more than twenty-four hours trying to infuse massive amounts of blood through five or six venous catheters. Clinical records obtained from current operations involving trauma and liver transplants reveal estimated blood losses that are in excess of two hundred and fifty liters, a volume approximately fifty times the total blood volume of an adult. Although it is not very common for an anesthesiologist or a trauma surgeon to find massive exsanguination (ten liters and more) in a major trauma and transplant center, this is however unusual to successfully resuscitate a patient with a loss. of massive blood volume with traditional methods. The patent of Stephens, Jr. and cois. US patent No. 5,061,241, discloses a rapid infusion device capable of pumping a high volume, composed of two units. A permanent unit comprising a base portion housing an AC / DC motor, a roller pump and other associated gauges and switches. A disposable unit includes a filter reservoir, a heat exchanger component, and a directed tubing that is conducted to the roller pump. The roller pump increases the volume of the fluid that is pumped by increasing the r.p.m. of the pumping unit and includes a pressure control valve. US Patent No. 4,747,826 to Sessano, discloses a portable infusion apparatus consisting of a supply source, a housing and associated tubes and valves leading to an infusion pump which can be either a roller head centrifugal pump. SUMMARY OF THE INVENTION With the background of the drawbacks of current blood infusion apparatuses, indicated above, the applicant has developed the rapid infusion system disclosed and claimed in the present application. An objective of the present invention is to provide an apparatus that could meet the various rapid infusion requirements while at the same time reducing the number of medical and / or technical personnel required to monitor the equipment, desiring further improvement on the practices and known systems currently used in critical life treatment situations. A further objective of the present invention is to provide an adjustable system which is capable of infusing high volume blood and / or volume expander fluids in a patient. BRIEF DESCRIPTION OF THE DRAWINGS Referring to the drawings: Figure 1 is a front elevation view of the rapid infusion system. Figure 2 is a sectional view of an embodiment of the present invention with a cover or a cover wall removed. Figure 3 is a sectional view of another embodiment of the present invention with a cover or a cover wall removed. Figure 4 is a sectional view of a pump mechanism used in an embodiment of the present invention. Figure 5 is a sectional view of a pump mechanism used in another embodiment of the present invention. Figure 65 is a side view of a pumping mechanism that connects to the rapid infusion unit. Figure 7 is a front view showing an IV pole, a fluid bag and the rapid infusion system of the present invention. Figure 8 is a sectional view of the present invention showing the monitoring apparatus of the P.V.C. optional. DESCRIPTION OF THE PREFERRED MODALITIES Rapid infusion of IV fluid has been proven to save lives in patients suffering from blood loss. All currently available rapid infusion devices are large, heavy, prohibitively expensive and extremely expensive to operate, due to the extremely expensive special equipment that must be discarded after each use. All these devices include fluid heaters that add to the weight and size of the unit and all operate using the same large, heavy, non-portable roller pumping mechanism. Rapid infusion devices of the state of the art can not be used with the typical peripheral IV cannulas but require central line catheters of large internal diameter or venous cut that can be inserted only by doctors. Although rapid infusion or hyperinfusion is proven to save lives, this technology is not commonly available to the public in most hospitals due to the aforementioned reasons. The rapid infusion device of the present invention solves many of the current problems of the devices of the state of the art. It is small and portable and if desired, can be built to fit the palm of your hand. It is not cato and may be potentially available to patients, even in rural hospitals. It can be used with any IV line or other hospital equipment commonly available and that can generate flows equivalent to or superior to those of the existing rapid infusion devices. The present invented device can be used with central lines, vein cutting catheters or peripheral IVs that nurses and paramedics can insert, therefore, it has potential application for use in ambulances, in the field, in emergency rooms, military applications, battlefield situations and the like. The present inventive device is cost effective and environmentally friendly since the current pumping mechanism can be removed and sterilized, so that no waste or replenishment is needed. The device can be used for blood transfusions by imparting movement through a pressure change, ie, it can add fluid to the pipe that already contains the same or a different fluid and thereby imparts greater movement to the fluid that is already in the pipe without said fluid coming into contact with any portion of the device, so it can be used any pump mechanism. The present invention also has excellent potential for military applications. The current hyperinfusion devices do not take place in the military or battlefield areas. Its cost, size, lack of efficiency and lack of qualified personnel in the field exclude the use of hyperinfusion devices of the state of the art in such medium. Therefore, the militia does not have access to hyperinfusion technology due to the size, cost and complexity of current devices. The present invention is small and portable. It can be sized to fit the size of a person's hand and can be energized with current C.A. or C.D. If energized by DC current, standard batteries, including rechargeable batteries, can be used. Preferably, when the infuser of the present invention is used in the field or in military applications, it may be less than about 5 inches, about 2.75 inches or about 2 inches, however, the size depends on the components employed. The patient who suffers blood loss by measuring the pressure in the larger central veins (central venous pressure P.V.C.) is the best method to assess the effectiveness of volume replacement. If the P.V.C. it is low, the patient does not have adequate intravascular volume and thus the resuscitation fluid is also necessary. A high P.V.C. it is indicative of a volume overload and can result in heart failure and pulmonary (or fluid) edema in the lungs. Today to measure P.V.C. A larger catheter is placed in the patient's neck and connected to a pressure transconductor that converts pressure changes into an electrical signal deployed on an oscilloscope-type monitor. Intensive care units and operating rooms are usually the only areas of the hospital capable of measuring P.V.C. In ER placement, fluid administration is empirically measured using only the patient's blood pressure and pulse to assess the adequacy of volume replacement. Hyperinfusion devices are best used while simultaneously monitoring the P.V.C. The volume and flow rate in the patient can then be adjusted quickly and accurately to maintain adequate P.V.C., but the complications of heart failure and pulmonary edema due to fluid overload due to human adjustment error are not eliminated. The hyperinfusion of the present invention could optionally infuse fluids and measure P.V.C. simultaneously through a single central venous catheter. The small device not only hyperinfuses fluid and monitors the P.V.C., but can adjust the flow rate automatically to achieve any P.V.C. what the doctor wants. The present invention not only ensures the ideal infusion rate for any particular patient, but is a cheap alternative to the P.V.C. large and catos and obviates the need to put a second venous catheter dedicated just to read the P.V.C. The present invention may include a selector to establish the P.V.C. desired, a screen that displays the P.V.C. real and a mechanism that stops the pump at previously established time intervals in order to safely measure the P.V.C. The operator only needs to select how many times per minute the pump must be stopped, read the P.V.C. and adjust the flow rate accordingly. A manual mode is provided to infuse at a simple fixed rate with a switch that will stop the pump and give the operator a reading of P.V.C. snapshot. Control media that maintain P.V.C. may optionally be employed. within a previously established range. The adjustable pump means respond to signals from the control means and increase or decrease the fluid pressure and / or the flow rate in response thereto. Advantageously, the device of the invention has an alarm indicating when the IV fluid bag is about to be emptied. The rapid infusion system is composed of two larger portions. A portion includes permanent equipment, i.e. equipment that does not need to be sterilized and can be used again and again, such as the pump motor and its related controls and optional equipment such as a P.V.C. and the related controls, optionally a heating element and related controls and attached means. The other portion includes the removable system components such as the pump, pump accessories or rollers, fluid or blood container, valves and tubing. The described rapid infusion system is an adjustable mechanical pumping system for rapidly administering blood and / or volume expander fluids to a patient suffering from acute hypovolemia. The operating principle of the invention described is of a resistance mechanically overcome. The term "blood" is used herein to describe or refer to the blood and / or volume expander fluids supplied by the system since not only blood, but any other desired fluid, may be delivered through the system. "Container" as used herein, includes one or more standard IV bags or separate container (s) when it is more practical than an IV bag. The object of the invention pertains to a novel system for rapid venous infusion of a physiological fluid, such as blood, which includes in combination a container for the physiological fluid, which has an inlet port to receive the physiological fluid and a port of exit to supply the same, an infusion pump to drive the physiological fluid through the system, optional means to control the temperature of the physiological fluid, optional means to filter the occlusion materials of the physiological fluid, optional means to detect the pressure of the physiological fluid , means for infusing the physiological fluid into a venous system and means for transporting the physiological fluid to and from each of the components of the system. In a preferred embodiment, the adjustable rapid infusion system comprises a container having a capacity that can exceed a few liters to maintain a supply of physiological fluid, the inventive infusion pump being selected from the group consisting of a gear pump, a pump turbine, an occlusive pump with roller head, a non-occlusive centrifugal pump and the like; optional portions such as means for controlling the pressure, means for controlling the temperature, a filter for removing any occlusive material from the physiological fluid; a detector for detecting the presence of air bubbles in the physiological fluid in conjunction with means for cutting the flow in the conduit in response to a detected air bubble. Advantageously, the pump infinitely adjusts and can provide fluid flow rates from less than about 10 cc / min to more than about 2000 cc / min.

Optionally, the system could also include a temperature detector at the output of the temperature control means for measuring and adjusting the physiological temperature, to keep the temperature within acceptable limits. The system may also include reading means that display the fluid temperature, pressure line, fluid flow rate and total volume of the infused fluid. The inventive system has a variable speed pump motor such that the amount of volume that is pumped inside can be increased, merely by the increase of the r.p.m. the motor. The container can contain plural stages of filters and be provided with a plurality of entries so that the volume of the multiple sources can be fed into the container to meet any high demand requirement of a patient. As stated above, the system comprises a permanent portion and a removable and sterilizable portion. The removable portion includes a gear pump and other components with which the volume is brought into direct contact. The removable aspect of the invention provides an extra measure of protection against contamination to a subsequent patient. Referring now in detail to FIG. 1, the rapid infusion device 10 comprises an on / off switch 11, an on / off switch of the feedback mode of P.V.C. a variable flow rate control 13 to be used when the P.V.C. is not being monitored. and a liquid crystal display 14 for reading the P.V.C. The pumping mechanism 15 is directed by the device 10 and is removably connected to it, by joining it to the arrow 16. Optionally, the pumping mechanism 15 can be embedded within the device 10 such that it does not extend outside it. The device 10 also includes an input support of P.V.C. 17, a fluid flow meter 18, an AC / DC selector switch 19, a regulator of P.V.C. 20, for use in a feedback mode and an external charge / supply port. Figure 2 is a sectional view of an embodiment of the present invention wherein the device 40 has a battery pack 41 connected to a central venous pressure feedback regulator 42. A steered gearbox 43, for directing a mechanism of pump (not shown) connected to an arrow 44, is directed by a motor 45. Means for varying the resistance 46 connected to the battery pack 41 and to the motor 45 and which can vary the speed of the motor 44 and thus the speed input rotational to the gearbox 43 and to the pumping mechanism.

Figure 3 is a sectional view of another embodiment of the present invention wherein the device 60 has a battery pack 61, a regulator of P.C. 62, a motor 63 with an arrow 64, and a motor 65 with an arrow 67. A means for varying the resistance 66 is connected to the battery pack 61, to the regulator of P.V.C. 62, the motor 65 and the motor 63, being able to vary the speed of the motors 63 and 65, so that the rotational speed input varies to the single or multiple pump mechanism (s) (not shown) which are attached to arrows 64 and 67. Figure 4 is a sectional view of a type of pump usable in an embodiment of the present invention. The pump 80 is attached to the device 10, which directs the pump means 82 and 83, thereby imparting movement to the fluid received from a container through the opening 81 and exiting through the opening 84. As can be seen , the fluid goes through the channels around the circumference of the means of the gear pump 82 and 83. Figure 5 is a sectional view of a type of pump usable in another embodiment of the present invention, wherein the mechanism 100 is attached to the arrow 16 of the device 10 which directs the pump means 103 and 102, thereby imparting movement to the fluid from a container received through the opening 101 and exiting through the opening 104. As it can be seen the fluid goes between the pump means 102 and 103. Figure 6, is a side view of a pumping mechanism usable with the present invention whereby the arrow 122 is connected to the arrow 16 of the unit 10, whereby the steering gear 123 imparts movement to the fluid received from a container through of the opening 121 and exiting through the opening 124. The projecting shoulders 125 provide security to the connection with the pipe or the like. Figure 7 is a typical IV array 140 for securing an IV bag 141 containing fluid which flows through line 143 to the rapid infusion device of the present invention 142. The device 142 is attached to a pole 147 through the connecting means 146 and imparts movement to the fluid from the bag 141 and directs it directs through the pipe 144. The device 14 can be mechanically driven by an external power source through a cord 145. Figure 8 is a Sections view showing an optional IV monitoring system for the present invention. The pumping mechanism 160 contains a pressure probe 161 connected by a conduit 162 to the ou 165 of the pumping mechanism. The fluid input of the pumping mechanism from a container through the inlet 164 so that the movement is imparted to the fluid by the gears of the pumping mechanism 163. The fluid pressure as it exits the pump is directed through the ou 165 and line 162 that communicates with pressure probe 161. Traditional methods or different standards of intravenous fluid administration, the rapid infusion system can provide continuous total replacement of the blood volume of an adult human through any type of bleeding, for an indefinite period of time and can quickly regulate the temperature of the fluid with a minimum increase in resistance to flow, easily and quickly administer massive amounts of blood to a single patient during a simple operation, administer the physiological fluid maintaining at a predetermined temperature in the flow rate in excess of 2000 ce per minute, and simultaneous neously it allows deploying and controlling fluid temperature, flow rate, pressure line and the total volume administered physiological fluid. The system is also portable and capable of being quickly and easily used in an emergency situation or by emergency personnel in the field. The blood supply through the system can include coagulation factors and an infinite amount of blood can be infused in an indefinite period of time based on the pumping mechanism, the size of the tubing, etc. , employees . If desired the present invention may consist of multiple pumps for infusing blood or the like, to a patient through catheters, whereby it provides the fluids in volumes to the patient that are far in excess of those possible by the current infusers. While the invention has been described in its preferred embodiment, it should be understood that the words that have been used are descriptive words rather than limitation and that changes may be made within the substance of the appended claims without departing from the spirit and scope of the invention.

Claims (27)

1. NOVELTY OF THE INVENTION Having described the present invention, it is considered as novelty and therefore the content of the following CLAIMS is claimed as property 1. A rapid infusion system for rapidly administering blood and / or volume expander fluid to a patient, the rapid infusion device comprising a combination: a) a permanent portion; and b) a removable portion; wherein the permanent portion includes steering means and control means related thereto; and? where the removable portion includes its -components that come into contact with the fluid infused to the patient; and wherein the steering means is provided to adjust the fluid flow rate. The system according to claim 1, characterized in that the removable portion includes pumping means operatively connected to the steering means. The system according to claim 2, characterized in that the pumping means is selected from the group consisting of a gear mechanism, a turbine mechanism, a centrifuge mechanism and a roller mechanism. The system according to claim 3, characterized in that the pumping means is a roller mechanism and includes a pipe of flexible and disposable length that serves as a pumping chamber. The system according to claim 1, characterized in that the removable portion is sterilizable and reusable. The system according to claim 2, characterized in that the fluid flow rate can provide from less than about 10 cc / min to more than about 2000 cc / min. The system according to claim 1, characterized in that the flow rate is infinitely adjustable. 8. A system for the venous infusion of a physiological fluid to a patient with an adjustable flow rate comprising in combination: a) a container for the physiological fluid to administer it; (b) a container for physiological fluid not directly obtained from the patient to be delivered to the container; (c) an adjustable flow rate pumping means for propelling the physiological fluid through the system; wherein the pumping means comprises a steering means and a contact portion of the removable fluid. The system according to claim 8, characterized in that it can provide the flow rate from less than 10 cc / min to more- about 2000 cc / min. The system according to claim 8, characterized in that the flow rate is infinitely adjustable. The system according to claim 10, characterized in that the removable portion is sterilizable and reusable. 12. A method for rapid infusion of a physiological fluid into the venous system of a patient, comprising the steps of: (a) providing a container for a physiological fluid to be infused into a patient; (b) propelling the physiological fluid from the container by means of a portable infusion mechanism of adjustable flow rate having removable pumping means and direction in the venous system of the patient. The method according to claim 12, characterized in that it can provide the flow rate from less than 10 cc / min to more than about 2000 cc / min. The method according to claim 12, characterized in that the flow rate is infinitely adjustable. 15. A power infuser comprising at least one fluid container, fluid conduit means communicating with the container, propellant means downstream of the container, means for controlling the fluid pressure, the fluid conduit means including tubing in communication with the fluid with the container and separate means in communication with the tubing means near the container to selectively discharge the fluid to the patient, wherein the thruster means comprises a steering means that does not contact the fluid and the medium of pumping connected removably in the same, and that puts in contact and imparts movement to the fluid. 16. The power infuser according to claim 15, characterized in that it can provide the flow rate from less than 10 cc / min to more than about 2000 cc / min. 17. The power infuser according to claim 15, characterized in that the flow rate is infinitely adjustable. The power infuser according to claim 15, characterized in that it includes a connector Y in the fluid conduit to the patient to provide branched conduits to the patient, including the branched conduits means to provide communication with the separate intravenous infusion system and means for accessing with a syringe. 19. The power infuser according to claim 15, characterized in that the fluid container is of sufficient capacity to transfuse the entire blood volume of an adult patient. 20. The power infuser according to claim 15, characterized in that it is of such a size and weight that it can be easily held while being used by a person. 21. The power infuser according to claim 15, characterized in that the pumping means is energized by direct current (DC). 22. The power infuser according to claim 15, characterized in that the pumping means is energized by alternating current (AC). 23. The power infuser according to claim 15, characterized in that it has more than one pumping means and the ability to infuse fluids in a person in multiple points and for infusions of multiple type of fluids in a person. 24. The power infuser according to claim 15, characterized in that it includes means for measuring central venous pressure during infusion using a simple venous catheter. 25. The power infuser according to claim 24, characterized in that it includes pumping control means in response to the measurement of central venous pressure. 26. The rapid infusion system according to claim 1, characterized in that it is portable. 27. The power infuser according to claim 21, characterized in that the pumping means is energized by a battery selected from the group consisting of standard and rechargeable batteries.