Patent Application
20130267919
The present invention relates to the art of suction regulators or vacuum flow control devices.
Not applicable.
Suction regulators have been used in hospitals since the 1950s. Dedicated devices or modern regulators designed for specific applications were introduced in the 1960s. The intermittent vacuum regulator was introduced in the 1970s and the combined regulator followed. No significant technological changes have happened since.
Accordingly, hospital and clinic facilities-management systems include vacuum pumps that maintain a negative pressure of −760 millimeters mercury (−1 atmosphere; −14.7 pounds per square inch negative pressure) below atmospheric. Vacuum is defined as the difference between atmospheric pressure and subatmospheric pressure, created by a vacuum-producing device such as a vacuum pump. Suction is defined as the flow of air or fluid, and in some cases solids such as clots and tissue, through suction tubing. Flow rate refers to how fast vacuum pressures draw fluids and air into collection vessel systems during suctioning procedures. Flow is created by lowering the pressure at one end of the tube. Resistance causes reduction in flow rates and prevents maximum flow potential from being achieved.
This “vacuum” is delivered to each bedside via a complex of conduits within the clinic wall structure typically found throughout a hospital or surgery center. At the patient bedside a standard fitting is mounted to the wall or head-board, thereby allowing a regulator to “plug in” to the available vacuum. As different fluids and clinical situations call for different vacuum pressure, a regulator is mounted on the wall to allow for manual adjustment of the vacuum delivered to the patient.
All these devices have relied on the hospital vacuum source as the main power generating engine to control the several mechanical valves to deliver the vacuum either intermittent or continuous. A few manufacturers have made compact, lightweight regulators enclosed in a protective plastic housing; however, some of these devices, are still dependent on the “mechanical” calibration and parts to generate the vacuum pulse.
The main purpose of modern suction regulators is to control suction. Types of suction regulators include:
General-purpose suction regulators used in recovery rooms; in the intensive care and coronary care units; and at the patient's bedside. All of them rely on mechanical control.
Surgical suction regulators are used to control the removal of secretions such as vomitus, mucus, or blood during surgical procedures, as well as secretions in wound cavities after surgery.
Tracheal suction regulators control suctioning that is performed directly or through an endotracheal or tracheostomy tube to clear excess secretions from the trachea or tracheobronchial tree; they are commonly used postoperatively for thoracic surgical patients, postanesthesia patients, and certain intensive care unit patients.
Regulated oral, nasal, and pharyngeal suctioning may be needed to remove excessive secretions from unconscious and/or critically ill patients, as well as from patients recovering from anesthesia. In suctioning, semisolids, liquids, and gases are removed from the stomach and intestinal tract to prevent the buildup of gastric contents and swallowed air.
Intermittent or controlled suctioning is often needed with all the aforementioned regulators to minimize damage to the mucosal lining and blockage of the catheter tip if the tip entraps solids. Too much resistance may compromise the functional efficacy of a suction collection system to the point where potentially life-threatening situations in a clinical setting could occur.
In Thoracic suction regulators produce the vacuum levels and high airflows needed to remove blood, exudate, and air from the pleural cavity, thereby counteracting pneumothorax and allowing the lung to reexpand.
Most human fluids are viscous, thereby requiring significant negative pressure “vacuum” to affect adequate flow. However, the suction catheter has a preset and is specific for the anatomic site. This “fixed mode” does not balance the flow and vacuum requirements. The flexible tube, referred to as a suction catheter, has one or several holes at the end thereby allowing flow of fluid to a container outside the body. For example, too many holes will provide adequate flow, but the pressure differential “vacuum” may not be maintained; too few holes will maintain adequate vacuum but may not allow sufficient fluid flow.
Not having accurate control of the vacuum source can pull tissue into the hole leading to injury and or damage to the tissue. Bleeding, perforation, and death of tissue may ensue along with serious clinical harm. Accordingly, there is a need in the industry to mitigate tissue damage.
Prior inventions have approached the issue by limiting the time that the vacuum is applied to the suction catheter. Clinical standards call for 16 seconds of applied vacuum followed by an 8 second “off” period whereby the tissue is allowed to float away from the suction catheter. This “off” period has been determined to be necessary to avoid tissue damage.
Until now, timing of the on-off cycle has been accomplished using the available negative pressure from the vacuum source. A diaphragm-bellows is allowed to collapse under the negative pressure, and atmospheric pressure is bled into the bellows at a specified rate. Mechanical work is performed by the bellows, which opens and closes the regulated pressure to the patient. Timing of the on-off cycle is performed by varying the cross sectional area of the orifice that fills and empties the bellows. This leads to a rather inaccurate timing cycle, and one that either cannot be adjusted by the clinician, or if adjusted, is subject to large variation of timing as it tends to drift over time. Similar problems can also be found in a modular approach that uses a sandwich of plastic plates, air channels, springs and gaskets to achieve the same function as the bellows.
There is also need within the industry to create an alternative to the prior suction regulator, allowing for a low cost, accurate, electronic device that avoids the timing variations associated with traditional vacuum-timed regulators.
The foregoing summary, as well as the following detailed description of the invention, will be better understood when read in conjunction with the appended drawings. For illustrating the invention, the figures are shown in the embodiments that are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown. In the drawings:
The present invention depicts an inventive solution to the fore mentioned issues related to suction regulators.
Unless otherwise defined, all terms of art, notations and other scientific terms or terminology used herein are intended to have the meanings commonly understood by those of skill in the art to which this invention pertains. In some cases, terms with commonly understood meanings are defined herein for clarity and/or for ready reference, and the inclusion of such definitions herein should not necessarily be construed to represent a substantial difference over what is generally understood in the art. Many of the techniques and procedures described, or referenced herein, are well understood and commonly employed using conventional methodology by those skilled in the art.
The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.”
The phrase “and/or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Other elements may optionally be present other than the elements specifically identified by the “and/or” clause, whether related or unrelated to those elements specifically identified unless clearly indicated to the contrary. Thus, as a non-limiting example, a reference to “A and/or B,” when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A without B (optionally including elements other than B); in another embodiment, to B without A (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.
As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and/or” as defined above. For example, when separating items in a list, “or” or “and/or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of” or “exactly one of,” or, when used in the claims, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e. “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.” “Consisting essentially of,” when used in the claims, shall have its ordinary meaning as used in the field of patent law.
As used herein in the specification and in the claims, “Vacuum” refers to the difference between atmospheric pressure and sub-atmospheric pressure, created by a vacuum-producing device such as a vacuum pump.
As used herein in the specification and in the claims, “gas,” or “air” means a compressible fluid such as oxygen, nitrogen, hydrogen, air (a mixture of dry air contains roughly (by volume) 78.09% nitrogen, 20.95% oxygen, 0.93% argon, 0.039% carbon dioxide, and small amounts of other gases. Air also contains a variable amount of water vapor, on average around 1%.), carbon dioxide, nitrous oxide, anesthetic and other similar gases or any combination thereof.
As used herein in the specification and in the claims, the term “commands” refers to; direct, instruct, call on, require, and control of an element over another.
As used herein in the specification and in the claims, the term “link” or “linked” refers to a connection, connector, coupling, joint or a relationship between two things or elements where one thing affects the other, both wireless, wired or in combination of both.
As used herein in the specification and in the claims, the term “transmit” or “transmits” refers to pass on at least one signal or information, in both digital or analog form, from one place or element to another both wireless, and wired or in combination of both.
The invention herein applies generally to General-purpose, Surgical and Tracheal suction regulators. In one embodiment of the invention, at least one micro-latching valve 401 is opened and closed by at least one solenoid electromechanical actuator. The micro-latching solenoid valve in turns opens and closes at least one main valve 402 that is connected the hospital vacuum or gas intake conduit. The latching nature of the solenoid, along with its low power activation allows for a battery powered, long-life device. Timing and control of the electromechanical actuator is performed by a low power micro-controller 304. This provides opportunity for highly accurate timing cycles, user adjustable timing intervals and feedback loop control operations.
Referring now to the drawings in detail, in at least one embodiment of the invention, in
In another embodiment of the invention,
In a side view of one embodiment of the invention,
On a front view of one embodiment of the invention, after removing the vacuum gauge 102 from the gauge connector 305,
While some self-contained micro-controller systems 304 are very sophisticated, many have minimal requirements for memory and program length, with no operating system, and low software complexity. Typical input and output devices include; switches, relays, solenoids, LEDs, small or custom LCD displays, radio frequency devices, and sensors for data such as flow, pressure, temperature, humidity, light level, etc. A self-contained system micro-controller 304 can be used in the same way for the same purpose to achieve the same result as a non-embedded system.
The micro-controller 304 should provide real time (predictable, though not necessarily fast) response to events in the flow system it is controlling. In the invention herein, response to the pressures to control the micro-latching solenoid valve 401 which in turn controls the main valve 402. The micro-controller 304 for this application, usually contains several to dozens of general purpose input/output pins (GPIO). GPIO pins are software configurable to either an input or an output state. When GPIO pins are configured to an input state, they are often used to read sensors such as or external signals (such as flow and pressure). Configured to the output state, GPIO pins can drive external devices such as the vacuum gauge 102 or the micro-latching solenoid valve 401.
The wireless transmitter 504 as used in this invention comprises wireless communications which can be via: radio frequency communication, microwave communication, short-range communication, infrared (IR) short-range communication with at least one of the purposes being point-to-point communication, point-to-multipoint communication, broadcasting, cellular networks and other wireless networks. The wireless transmitter 504 for this suction regulator 100 is embodied in a wireless local area network (WLAN) which links two or more suction regulators 100 over a short distance using a wireless distribution method, usually providing a connection through an access point for Internet access. The use of spread-spectrum or OFDM technologies allows the suction regulators 100 to move around within a local coverage perimeter, and still remain connected to the network. Products using the IEEE 802.11 WLAN standards are marketed under the Wi-Fi brand name. In another embodiment, the wireless transmitter 504 is a fixed wireless technology that implements point-to-point links between suction regulators 100 or networks at two distant locations, often using dedicated microwave or BLUETOOTH® signals.
In one embodiment of this invention, the power source 303, is at least one lithium-ion battery. Although a DC or AC cable attached to the device 100, would work in the same way to achieve the same function and give the same result as a battery powered suction regulator 100. In this embodiment, a (lithium-manganese dioxide) LiMnO2 was used. This type of battery was chosen because the suction regulator 100 requires long shelf life and the selected battery has a very low rate of self discharge, usually around 10 years. A lithium-ion battery (sometimes Li-ion battery or LIB) is a family of rechargeable battery types in which lithium ions move from the negative electrode to the positive electrode during discharge, and back when charging. Any other type of chemistry in the power source 303 can be used in the same way to accomplish the same result, which is to move a micro-latching solenoid valve 401 typically around 5 milliwatts per actuation.
In another embodiment of the invention,
In yet another embodiment of the invention,
The at least one micro-controller 304 commands said at least one solenoid electromechanical actuator 1107, and at least on power source 303, said at least one power source 303 provides power to said at least one electromechanical actuator 1107 and said at least one micro-controller 304, wherein the at least one micro-latching solenoid valve 401 controls the flow of vacuum through the at least one main valve 402. The suction regulator 100, further comprises, a vacuum gauge 102, a mode switch 302, a manual air regulator 301, a patient vacuum port 201, and at least one flow sensor 1201.
In one embodiment of the invention,
The sliding seal body 1003 as used herein comprises embodiments in a variety of valve types, such as the ones used in the automatic control of air, gases and other industrial compressible fluids. These include valve types which have linear and rotary spindle movement. Linear types include globe valves, sliding membrane seal, slide valves and bellows. Rotary types include ball valves, butterfly valves, plug valves and their variants. All of them can be used in the same way, for the same function to achieve the result of opening and closing the vacuum source port to vacuum 202 from the patient at the port to patient 201.
In one embodiment of the invention,
The solenoid electromechanical actuator 1107 is drawn in by the vacuum though the normally closed conduit connector 801. It is normally closed because the source vacuum forces the micro-latching solenoid valve 1103 to close against the micro-latching solenoid valve conduit 1102. When a pulse of electricity is fed into micro-latching valve connector 503 and goes to the solenoid actuator coil 1106, the end of the solenoid electromechanical actuator 1107 is magnetized negative, thereby attracting to permanent magnet 1108. The micro-latching solenoid valve is moved in direction 1105, thereby opening the micro-latching solenoid valve conduit 1102 normally closed by the source vacuum, or micro-latching solenoid valve spring 1104.
The latching nature of the solenoid valve 401 avoids the power requirements of a standard solenoid. A 10 millisecond pulse of current moves the solenoid 1107 to one extreme of displacement where it stays in the location without additional power. In an alternative embodiment, a similar pulse of opposite polarity will actuate the solenoid 1107 to its alternative position, again without the need of continuous power.
The solenoid such as the one depicted in
In detail, a pulse of electricity is generated by the micro-controller 304. This pulse, is received by micro-latching valve connector 503, which in turn passes electricity to the solenoid actuator coil 1106, which in turn magnetizes the solenoid electromechanical actuator 1107 negative, thereby attracting to permanent magnet 1108. This electromagnetically induced movement overcomes the source vacuum from normally closed conduit 701. Hence, this attraction causes a movement that opens micro-latching solenoid valve 1103 to allow the flow of vacuum to pass from common conduit 702 linked to the main valve 402 to the normally closed conduit 701. By opening micro-latching solenoid valve conduit 1102 vacuum forces sliding seal body 1003 to move against a position set by main valve spring 1002 widening the valve chamber 1004 allowing atmospheric air 1011 to enter through valve atmospheric entrance port 901. Atmospheric pressure 1011 on the right side of the valve body overcomes the spring pressure 1002, and the valve body slides to the left.
The ‘O’ rings 1012 illustrated in the
In one embodiment of the invention,
Atmospheric pressure 1011 on the right side of the valve body overcomes the spring pressure 1002, and the valve body slides to the left. A person skilled in the art can calculate the forces needed to open and close the main valve 402 by measuring the diameter of the main valve 402, and the spring constant, 1002, and the pressure applied to both sides of the sliding valve body 1003.
When the sliding valve body 1003 opens or closes the port to source vacuum 202 and the port to patient 201, flow of vacuum from the vacuum direction from patient 1009 vacuum direction to source vacuum 1010 is controlled. This control is attributed to the flow sensors 1201 and 1202 who in turn sends a signal of the amount of flow in both the source vacuum intake port 202 and the patient vacuum port 201. This information is transformed, stored analyzed or compared to pre-set ranges in the micro-controller 304 which in turns send more or less electrical pulses via feed back loop 1204 to the micro-latching solenoid valve 401 to open or close the flow of vacuum to the main valve 402. This “off” period has been determined by the micro-controller 304 to be necessary to avoid any tissue damage.
At least one of the purposes of the mesh network 1702 is to provide a visual landscape to persons responsible for the proper function and maintenance of medical devices within a health care setting using a wireless device or monitoring station 1704 or be monitored at a manufacturing facility via an internet connection 1703. The wireless mesh network 1702 can display device specific information or provide information on device movement/location.
The visual landscape example is depicted in
The device specific information that can be provided wirelessly from the device 100 to the user at at least one monitoring station 1704 might include; vacuum source pressure, battery life, location in relation to other devices, date when maintenance was last performed, next maintenance due date, repair history, ambient temperature, location in relation to other devices etc. All this information can be fed wirelessly 1703 by the router 1701 to the internet 1705 were the information can be stored in servers 1705 for later retrieval, analysis and monitoring.
Each wall suction regulator 100 is equipped with and utilizes appropriate control circuitry such that each unit is part of a mesh network 1702, providing communication either via wire, fiber optic, radio signal, or light signal 1702 between units 100. Such mesh network enables all of the units (an array) either within a physical plant (local area network) or outside of a physical plant (wide area network) to communicate with each other.
Software revisions can be sent via wire, light, or radio to a single unit 100, and this unit 100 can pass the software revision to each successive unit within the array, be it in a local area network within a structure or outside of the structure in a wide area network. Battery status, working status, temperature, time of operation, out of range alarm, wall suction pressure, hospital infrastructure pressure, etc., may be sent along the mesh network to a plurality of central monitoring stations 1704 within a local area network 1702 or wide area network 1703, such that all of these parameters can be monitored even though the unit 100 of interest within the array of units is outside of the radio range 1708 of the monitoring station 1704.
In yet another embodiment of the invention, the mesh network 1708 can be built upon an array connected via wire, radio signal, light signal, fiber optic signal, etc. Each unit 100 within the array has a unique electronic address. There is may or may not be a master unit, and each unit 100 is identical. Hence, each unit in the array may assume a control function if deemed necessary by the programmer, although a master unit is not necessary for the mesh network to function properly.
While the foregoing written description of the invention enables one of ordinary skill to make and use what is considered presently to be the best mode thereof, those of ordinary skill will understand and appreciate the existence of variations, combinations, and equivalents of the specific embodiment, method, and examples herein. The invention should therefore not be limited by the above described embodiment, method, and examples, but by all embodiments and methods within the scope and spirit of the invention.
It is to be appreciated that the Detailed Description section, and not the Abstract section, is intended to be used to interpret the claims. The Abstract section may set forth one or more but not all exemplary embodiments of the present invention as contemplated by the inventor(s), and thus, are not intended to limit the present invention and the appended claims in any way.
The present invention has been described above with the aid of functional building blocks illustrating the implementation of specified functions and relationships thereof. The boundaries of these functional building blocks have been arbitrarily defined herein for the convenience of the description. Alternate boundaries can be defined so long as the specified functions and relationships thereof are appropriately performed.
The foregoing description of the specific embodiments will so fully reveal the general nature of the invention that others can, by applying knowledge within the skill of the art, readily modify and/or adapt for various applications such specific embodiments, without undue experimentation, without departing from the general concept of the present invention. Therefore, such adaptations and modifications are intended to be within the meaning and range of equivalents of the disclosed embodiments, based on the teaching and guidance presented herein. It is to be understood that the phraseology or terminology herein is for the purpose of description and not of limitation, such that the terminology or phraseology of the present specification is to be interpreted by the skilled artisan in light of the teachings and guidance. The breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.
