The present invention relates generally to a surgical fluid management system and more particularly to a surgical fluid management system of the type used in endoscopic procedures.
Surgical fluid management systems typically deliver a fluid, such as saline, to a targeted working space or body cavity to provide access and visibility to the physician performing a procedure in the working space or body cavity. The fluid usually provides a pressure sufficient to “open” the space (i.e. create a working space for the procedure) as well as flushing blood and debris from the space. Typically, the surgical fluid management system includes a control system for maintaining a preset fluid pressure in a working space.
Surgical fluid management systems are often inconvenient to use and difficult to monitor. Further, the control systems of such fluid management systems are often unable to accurately measure pressure in a working space when the patient and the fluid management console are at different elevations.
It would therefore be beneficial to provide improved surgical fluid management systems that overcome at least some of these shortcomings. In particular, it would be desirable to provide surgical fluid management systems with an improved ability to measure pressure in a patient working space and to utilize the improved pressure measurements for determining changes in elevation of a surgical tool delivering a surgical fluid to the working space. At least some of these objectives will be met by the inventions described below.
US20160242844; US20180326144; and US20190030235 have common inventorship and describing surgical fluid management systems.
In general, the fluid management system includes a disposable cassette carrying inflow and/or outflow tubing sections that are configured for releasably mating with a control unit and roller pump head(s). The fluid management system can be adapted to automatically recognize the type of disposable cassette and the volume of fluid in an inflow source. During operation, the system can calculate pressure in the working space based on fluid pressure in the cassette tubing set, and provide for inflow and outflow control to maintain a desired pressure in the working space or adjust other operating parameters. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims.
The present invention provides improved fluid management systems and methods for their use. In particular, the present invention provides a disposable tubing cassette, a consoles for detachably receiving the disposable tubing cassette, and methods for mounting and replacing the tubing cassette on the console. The disposable tubing cassette will usually include a first flexible tubing loop, where the tube is used for delivering fluid from a fluid source to a patient. A second tube may be used for removing fluid from the patient and delivering the fluid to a disposal receptacle. The fluid management systems may also be configured to alert the user when the cassette has been successfully loaded or, conversely, when the cassette has not been successfully loaded. Further capabilities include sensing conditions of the fluid, in particular, positive and negative pressures in a fluid in an inflow pathway of the cassette. Automatic locking capabilities may also be provided by a motor and control mechanism carried by the console.
In a first specific aspect, the present invention provides a disposable cassette for use with a surgical fluid management system having a console with a peristaltic pump rotor. The cassette comprises a housing, a flexible tube located in the housing configured to engage the peristaltic pump rotor when the cassette is mounted on the console.
In other specific embodiments, the disposable cassette may further comprise a flexible membrane on a sensing window on at least one of the first and second flexible tubes. The at least one sensing window will usually be positioned to align with a pressure or force sensor on the console when the cassette is mounted on the console. In an exemplary embodiment, the membrane of the sensing window comprises a thin resilient element overlying an interior chamber in a housing that communicates with a fluid flow path in inflow tubing carried by the cassette. In a specific embodiment, the pressure sensor in the console is mounted on a sliding base plate that carries the cassette.
In another specific embodiment, the cassette membrane and cooperating flexible membrane of the pressure sensor in the console are adapted to maintain contact with one another to thus allow measuring both positive and negative pressures in a fluid column in the cassette. The ability to measure negative pressures in the cassette is relevant when the treatment tool in the console are different elevations which then allows for more precise calculation of the actual fluid pressure in the working space. In one specific embodiment, the cassette membrane and the sensor membrane carry magnets or magnetic response material to allow for detachable coupling of the services of the membranes.
In one particular aspect of the present invention, a cassette for use in a surgical fluid management system comprises a cassette housing, a flexible tube in the housing, and a pressure-transmitting membrane in a wall of the cassette housing. The cassette is intended for use in a surgical fluid management system which typically includes a console with a pump rotor and a pressure-sensing membrane. The flexible tubing in the cassette housing has a lumen configured to interface with the pump rotor of the console and to carry a fluid from a fluid source, typically to a surgical tool being used in a patient working space. The pressure-transmitting membrane in the cassette housing is in fluid communication with the lumen of the flexible tubing, and typically the pressure-transmitting membrane is configured to flex outwardly in response to a positive pressure in the flexible tube lumen and to flex inwardly in response to a negative pressure in the flexible tube lumen. To help assure that the pressure of the surgical fluid in the fluid tubing is accurately transmitted to the console of the surgical fluid management system, the pressure transmitting membrane will be configured to detachably adhere to or to press against and deform the pressure-sensing membrane when the cassette is received on the pump rotor.
Configuring the pressure-transmitting membrane to detachably adhere to and/or to press against and deform the pressure-sensing membrane is advantageous in that such enhanced proximity will improve the accuracy of pressure transmission across the adjacent membranes and can be achieved in a number of specific ways. For example, the pressure-transmitting membrane may comprise a magnetic material configured to magnetically couple to a magnetic material in the pressure-sensing membrane. The phrase “magnetic material” includes both permanently magnetic materials, e.g. permanent magnets, and magnetizable materials, i.e. those which are magnetized and attracted to a permanent magnet. At least one of the magnetic materials in the pressure-transmitting membrane and the pressure-sensing membrane will usually be a permanent magnet, while the other of the membranes may possess either a permanent magnet or a magnetizable material.
Alternatively, the pressure-transmitting and/or the pressure-sensing membrane may be modified to include an adhesive coating on the surface that interfaces with the surface of the adjacent membrane. Suitable adhesive coatings include synthetic setai of the type which adhere to an adjacent surface via van der Waals forces. Low tack adhesives, such as the type used on sticky notes, may also be used. Either or both membranes may be coated with an adhesive lubricant, typically an oil-based lubricant of the type which has an inherent adhesive quality.
As a further alternative to magnetic materials and adherent materials, the pressure-sensing and/o pressure-transmitting membrane may comprise a suction adhesion element, such as a suction cup, configured to couple to the adjacent membrane surface.
As a still further alternative to coatings and mechanical attachment elements, the pressure-transmitting membrane in the cassette and/or the pressure-sensing membrane in the console may be deformed to bow or otherwise extend outwardly from a flat configuration. In this way, the deformed membrane will engage and deform the adjacent membrane such that an elastic recoil of the adjacent membrane will act to more closely conform to the adjacent membrane to enhance coupling and pressure/force transmission.
In preferred instances, the cassette housing will have a chamber therein which is in fluid communication with the lumen of the flexible tubing. The chamber will act as a reservoir for the fluid being delivered through the flexible tubing, and the pressure-transmitting membrane may comprise a wall of the chamber.
In an additional particular aspect of the present invention, a surgical fluid management system comprises a cassette as generally described above, in combination with a console having a pump rotor and a pressure-sensing membrane. The console may comprise a force-sensing element or pressure sensor, and one or more elements may be provided which project inwardly from a back surface of the pressure-sensing membrane to engage the force-sensing element. Such elements both transmit the force from the pressure-sensing membrane to the force or pressure-sensing element, and further act to deform a front surface of the pressure-sensing membrane outwardly. The outwardly extending (bowed) front surface of the pressure-sensing membrane may act to deform the pressure-transmitting membrane on the cassette inwardly to enhance contact between the membranes.
In a further particular aspect, the present invention provides a surgical fluid management system including a console and a cassette housing. A flexible tube is disposed in the cassette housing and has a lumen configured to interface with the pump rotor to carry a flow fluid from a fluid source. A pressure-transmitting membrane is formed in a wall of the cassette housing and is in fluid communication with the lumen of the flexible tubing. The pressure-transmitting membrane is configured to flex outwardly in response to a positive pressure in the lumen and to flex inwardly in response to a negative pressure in the lumen. A force sensing element in the console has one or more elements which project inwardly from a back surface of the pressure-sensing membrane to engage a force-sensing element, where one or more elements which project inwardly from a back surface of the pressure-sensing element deform a front surface of the pressure-sensing membrane outwardly to enhance contact between the adjacent surfaces of the two membranes.
In another particular aspect of the present invention, a surgical fluid management console is provided for use with a cassette having flexible tubing configured to interface with a pump rotor and a pressure-transmitting membrane. The surgical fluid management console includes a pump rotor configured to receive the flexible tubing of the cassette, a pressure-sensing membrane, and a force-sensing element. The pressure-sensing membrane is configured to engage the pressure-transmitting membrane when the flexible tubing is mounted on the pump rotor. One or more elements project inwardly from a back surface of the pressure-sensing membrane to engage the force-sensing element, where the one or more elements deform a front surface of the pressure-sensing membrane outwardly to engage and deform the pressure-transmitting membrane inwardly to enhance contact without said membranes.
In yet another particular aspect, the present invention provides a method for managing fluids during a medical procedure. The method comprises providing a fluid management console having a pump rotor, a pressure-sensing membrane, and a pressure sensor coupled to the pressure-sensing membrane. A cassette is also provided, where the cassette has a pressure-transmitting membrane and a flexible tube configured to receive fluid from a fluid source and to interface with the pump rotor. The cassette is removably mounted on the fluid management console in such a way that the pump rotor rotatably engages the flexible tubing, and the pressure-sensing membrane on the console engages the pressure-transmitting membrane on the cassette. Sufficient contact force between the two membranes is provided to enhance the transmission of pressure from the flexible tubing through the two membranes, to the pressure sensor in the console. The pump rotor may then be rotated to pressurize and deliver fluid from a fluid source through the flexible tubing, and the pressure sensor will be able to accurately generate a signal representative of a pressure in the flexible tubing.
In specific instances, the pressure sensor will be able to detect and measure both positive and negative pressure in the flexible tubing of the cassette, where positive and negative are conveniently measured relative to an initial pressure often set at the outset of a procedure. In more specific instances, the pressure-transmitting membrane and the pressure-sensing membrane may be adapted to flex outwardly and inwardly, when engaged against each other, in response to positive pressure and negative pressure, respectively, in the flexible tubing. In further specific instances, the console may be adapted to calculate a change in elevation of a treatment device delivering a fluid from the flexible tubing to a patient working space receiving fluid from the flexible tubing. Such calculations will typically be based upon a positive and/or negative pressure signal from the pressure sensor in the console. Conveniently, the positive and negative pressure signals may be based on a value zeroed at the beginning of the procedure when the membranes are in a neutral, un-stressed configuration.
Referring to
In
Referring to
Referring to
From
It can be understood that after inserting the cassette 105 and tubing loop over the pump head 115A, it is necessary to compress the tubing loop portion 148 between the pump head 115A and the eyebrow 152 which is be accomplished by the downwards sliding movement of the sliding base plate 155 which carries eyebrows 152 and the cassette 105. The pump head 115 and motor 116 are attached to the fixed base plate 160 which is coupled to the front panel 121 of the control unit 102 (
A locking motor (not visible) with a gear reduction mechanism rotates a gear 168 that is adapted to move the sliding base plate 155 the locking distance LD to thereby move the cassette 105 from a pre-locked position to a locked position. The locking motor can be activated by microswitch (not shown) in the console 102 or sliding base plate 155 that is activated when the cassette 105 is pushed inwardly against the sliding base plate 155.
Still referring to
By measuring fluid pressure with such a sensor mechanism in the control unit 102, the fluid pressure in the working space can be calculated, which is known in the prior art. Of particular interest in the present invention, the pressure sensing mechanism corresponding to the invention is configured to allow the pressure sensor 170 carried by the sliding base plate 155 to sense positive pressure in the fluid inflows as well as negative pressure. Prior art systems were designed only for sensing positive pressure in a fluid inflow.
In some surgical procedures such as gynecology, it is important to regulate or maintain “actual” fluid pressure in a working space WS within a narrow predetermined range or a not-to-exceed pressure. Further, it can be understood that the elevation of pump head 115A relative to the patient and the working space WS can make the fluid pressure in a working space different from the measured pressure in the cassette 105. In other words, the “actual” fluid pressure in a working space WS will differ from the pressure sensed at the control unit 102 simply based on the elevation difference between the control unit 102 and the working space WS. For example, in a gynecology procedure, the variance in the height of the control unit 102 relative to the working space WS can result in a sensed pressure at the control unit 102 that varies by up to 10% or more from the actual pressure in the working space WS. Over the time of a surgical procedure, such an inaccurate pressure measurement can be problematic and potentially cause injury to the patient by such overpressure in the working space WS.
Thus, in a typical procedure after the patient is prepared for surgery and the working space WS is filled with fluid and the tubing sets have been purged of air, a difference in elevation of the treatment device 118 or working space WS relative to the console 102 can be calculated by a positive or negative pressure reading the pressure sensor 170 which interfaces with the cassette membrane 180.
In order for the sensor membrane 180 to measure negative pressures, or flex inwardly relative to the cassette, a mechanism is provided to detachably adhere the cassette membrane 180 to the sensor membrane 175. Now referring to
Now turning to
The console 102 carries a controller 108 with a microprocesser that operates in accordance with algorithms to control inflows and outflows of a fluid to a working space to maintain a pre-set pressure level within the space. The console 102 can further include an RF generator or other energy source for coupling to a surgical instrument. The system optionally can monitor pressure in a space directly with a pressure sensor in a fluid communication with the space through an open channel in a device which then will allow the controller 108 to vary inflows and/or outflows to maintain the targeted pressure.
Although particular embodiments of the present invention have been described above in detail, it will be understood that this description is merely for purposes of illustration and the above description of the invention is not exhaustive. Specific features of the invention are shown in some drawings and not in others, and this is for convenience only and any feature may be combined with another in accordance with the invention. A number of variations and alternatives will be apparent to one having ordinary skills in the art. Such alternatives and variations are intended to be included within the scope of the claims. Particular features that are presented in dependent claims can be combined and fall within the scope of the invention. The invention also encompasses embodiments as if dependent claims were alternatively written in a multiple dependent claim format with reference to other independent claims.
This application claims the benefit of Provisional Application No. 62/684,672 (Attorney Docket No. 37644-716.101), filed on Jun. 13, 2018, the full disclosure of which is incorporated herein by reference.
Number | Date | Country | |
---|---|---|---|
62684672 | Jun 2018 | US |