Patent Application
20170120039
The present invention relates generally to methods and devices for performing arthroscopic surgery, and in particular for preventing or removing clogs in an arthroscopic fluid management system.
Minimally invasive surgery, also referred to herein as endoscopic surgery, often utilizes an irrigation system to force suitable biocompatible fluid into the area surrounding the surgical work site within a patient. The term “irrigation” is used broadly to mean any type of pressurized fluid flow whether it be for irrigation in particular or for other uses. Flexible plastic tubing is often used to transfer the fluid from a source to the work site and from the work site to a drain or other receptacle. Flexible tubing is also sometimes used as a pressure monitoring line to convey fluid pressure information to a control mechanism. Depending upon the procedure, the irrigating fluid is useful for various purposes such as tissue lavage, hydro-dissection, joint distension, uterine distension, etc. Known irrigation systems include electrically driven pump systems, in which a suitable fluid is pumped through flexible tubes from a source to the work site. Aspiration systems are also used and include a separate flexible tube that is connected to a vacuum source for aspirating the work site. Aspiration of the fluid can serve to either simply remove fluid to improve visibility, prevent undesirable fluid accumulation or high pressure at the work site, or to regulate the flow rate to maintain a predetermined fluid pressure at the work site.
Because the irrigation and aspiration functions are commonly used together, many combination irrigation/aspiration systems have been developed that perform both functions, often combined in one console which provides power and control. The irrigation system is generally used in conjunction with an aspiration system which removes the fluid pumped into the work site at a controlled rate depending on the flow rate selected by the surgeon. Each system utilizes a flexible tube to connect the fluid and vacuum sources to appropriate instruments inserted into the body.
While current systems can be effective to both irrigate and aspirate, the tubing can be prone to clogging. The flexible nature of the tubing can result in deformation of the tubing at a pinch point where flow through the tubing is controlled, and clogs can more readily occur due to such deformation. Large debris can also cause clogging to occur. Techniques are not readily available to clear clogs, and as a result the procedure can be prolonged increasing costs and resulting in user dissatisfaction.
Accordingly, there remains a need for improved methods and devices for performing arthroscopic surgery, and in particular for prevent or removing clogs in an arthroscopic fluid management system.
The present invention relates generally to methods and devices for performing arthroscopic surgery. In one aspect, a fluid management system is provided that includes a housing with an irrigation pump configured to couple to irrigation tubing for delivering fluid to a tissue site. The housing also includes an aspiration pump configured to couple to aspiration tubing for aspirating fluid from a tissue site. A coupling adjacent to the aspiration pump has first and second pathways formed therein that are configured to seat a first tubing portion and a second tubing portion of an aspiration tubing coupled to the aspiration pump. A valve assembly is disposed on the housing and is configured to selectively pinch closed tubing disposed within the first pathway and the second pathway. The valve assembly is configured to bias tubing disposed within the first and second pathways to an open position after the tubing is pinched closed by the valve assembly.
The fluid management system can vary in any number of ways. For example, the valve assembly can be slidably coupled to the coupling and can be slidable in a first direction to pinch closed tubing disposed within the first pathway and a second opposite direction to pinch closed tubing disposed within the second pathway. In another example, the valve assembly can include a tube guide configured to bias tubing disposed within one of the first and second pathways to an open position. As another example, the valve assembly can include first and second substantially concave cavities configured to seat tubing disposed within the first and second pathways, respectively, when the tubing is being biased to the open position. For another example, the valve assembly can include a cam loaded mechanism configured to provide a force on tubing seated in the first and second pathways to restore an original shape of the tubing when the tubing is in the open position. As yet another example, first and second biasing mechanisms can be coupled to the valve assembly with the first biasing mechanism being configured to bias tubing disposed within the first pathway to an open position and the second biasing mechanism being configured to bias tubing disposed within the second pathway to an open position.
In another aspect, a surgical method is provided that includes activating a fluid management device to deliver fluid through an irrigation tube to a tissue site and to aspirate fluid from the tissue site through a first aspiration tube. The method also includes activating a tool to cause a valve on the fluid management device to move from a first position, in which the first aspiration tube is open and a second aspiration tube is pinched closed, to a second position, in which the first aspiration tube is pinch closed and the second aspiration tube is open such that fluid is aspirated from the irrigation site through the second aspiration tube. In this method, the valve applies a force to the second aspiration tube to deform the second aspiration tube open when the valve moves from the first position to the second position.
The surgical method can vary in any number of ways. For example, the valve can slide to move from the first position to the second position. As another example, the valve can include a cam loaded mechanism that applies the force to the second aspiration tube to restore the second aspiration tube to an original shape of the second aspiration tube when the tube is in the open position. As another example, the valve can include a substantially concave cavity that seats the second aspiration tube when the tube is being deformed open.
In another aspect, a fluid management system is provided that includes a housing with an irrigation pump configured to couple to an irrigation tubing set. The housing also includes an aspiration pump configured to couple to an aspiration tubing set, a first tubing pathway for seating a first aspiration tube of an aspirating tubing set, and a second tubing pathway for seating a second aspiration tube of an aspiration tubing set. A selector valve is disposed on the housing and movable between a first position, a second position, and a neutral position. In the first position, the selector valve is configured to pinch a first aspiration tubing seated within the first tubing pathway to prevent the fluid flow therethrough while allowing the fluid flow through a second aspirating tubing seated within the second tubing pathway. In the second position, the selector valve is configured to pinch a second aspiration tubing seating within the second tubing pathway to prevent the fluid flow therethrough while allowing the fluid flow through a first aspirating tubing seating within the first tubing pathway. In the neutral position, the selector valve is configured to allow fluid flow through both a first aspiration tube seated within the first tubing pathway and a second aspiration tube seated within the second tubing pathway.
The fluid management system can vary in any number of ways. For example, the selector valve can be configured to rotate and pinch closed a length of tubing disposed within each of the first and second pathways. As another example, the selector valve can be rotatable 360° relative to the housing and the selector valve can be configured to sequentially squeeze a first tubing seated in the first tubing pathway and a second tubing seated within a second tubing pathway during a 360° rotation stroke. As yet another example, the housing can include an actuator for mechanically moving the selector valve between the first, second, and neutral positions. For another example, the system can include an irrigation tubing set having a tube with a first end portion coupled to the irrigation pump and a second end portion configured to couple to a tool, and an aspiration tubing set having a first tube coupled to the aspiration pump and second and third tubes each coupled to the first tube and seated within the first and second tubing pathways, respectively, with the second and third tubes each having an end configured to couple to a tool.
In another aspect, a surgical method is provided that includes activating a fluid management device to deliver fluid through an irrigation tube to a tissue site and to aspirate fluid from the tissue site through a first aspiration tube. The method also includes activating a tool to cause a valve on the fluid management device to pinch closed the first aspiration tube such that a second aspiration tube is opened and fluid is aspirated from the irrigation site through the second aspiration tube. The fluid management device rotates the valve along a length of at least one of the first and second aspirations tubes when a clog is detected.
The surgical method can vary in any number of ways. For example, prior to activating the fluid management device, the valve can be positioned in a neutral position such that the first and second aspiration tubes are open to allow fluid flow therethrough. As another example, the valve can rotate 360° when a clog is detected.
In another aspect, a fluid management system is provided that includes a housing with an irrigation pump configured to couple to irrigation tubing for delivering fluid to a tissue site. The housing also includes an aspiration pump configured to couple to aspiration tubing for aspirating fluid from a tissue site, a first tubing pathway for seating a first aspiration tube of an aspirating tubing set, and a second tubing pathway for seating a second aspiration tube of an aspiration tubing set. A valve is disposed on the housing and is configured to selectively occlude tubing disposed in one of the first and second tubing pathways while allowing fluid to flow through tubing disposed in the other one of the first and second tubing pathways. A vibratory mechanism is coupled to the valve and is configured to vibrate the valve so as to facilitate the flow of debris through tubing disposed within the first and second tubing pathways.
The fluid management system can vary in any number of ways. For example, the valve can be slidably coupled to the first tubing pathway and the second tubing pathway and can be slidable in a first direction to pinch closed tubing disposed within the first tubing pathway and a second opposite direction to pinch closed tubing disposed within the second tubing pathway. As another example, the valve can include a tube guide configured to bias tubing disposed within one of the first and second tubing pathways to an open position. In another example, the housing can have a self-cleaning mode that includes vibration of the vibratory mechanism. In another embodiment, the valve can include a cam loaded mechanism configured to provide a force on tubing seated in the first and second tubing pathways to restore an original shape of the tubing when the tubing is in the open position.
In another aspect, a surgical method is provided that includes activating a fluid management device to deliver fluid through an irrigation tube to a tissue site and to aspirate fluid from the tissue site through a first aspiration tube. The method also includes activating a tool to cause a valve on the fluid management device to move from a first position, in which the first aspiration tube is open and a second aspiration tube is closed, to a second position, in which the first aspiration tube is pinch closed and the second aspiration tube is open such that fluid is aspirated from the irrigation site through the second aspiration tube. In the method, at least one of a user or the fluid management devices activates a vibratory mechanism coupled to the valve to cause the valve to vibrate and thereby aid in the passage of debris through the first and second aspirations tubes.
The surgical method can vary in any number of ways. For example, prior to activating the vibratory mechanism, the valve can be positioned in a neutral position such that the first and second aspiration tubes are open to allow fluid flow therethrough. The method can include the step of, prior to activating the vibratory mechanism, activating a self-cleaning mode such that the valve moves between the first position and the second position.
This invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
Further, in the present disclosure, like-named components of the embodiments generally have similar features, and thus within a particular embodiment each feature of each like-named component is not necessarily fully elaborated upon. Additionally, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. A person skilled in the art will recognize that an equivalent to such linear and circular dimensions can easily be determined for any geometric shape. Sizes and shapes of the systems and devices, and the components thereof, can depend at least on the anatomy of the subject in which the systems and devices will be used, the size and shape of components with which the systems and devices will be used, and the methods and procedures in which the systems and devices will be used.
Various methods and devices for performing arthroscopic surgery are provided. In particular, methods and devices are provided for reshaping, unclogging, and vibrating tubing of an aspiration pump in a fluid management system.
Fluid management systems are used during minimally invasive surgery to irrigate and aspirate an area surrounding a surgical work site within a patient. As seen in
A fluid management system can thus be provided with a housing that includes an aspiration pump configured to couple to aspiration tubing for aspirating fluid from a tissue site. The aspiration pump can be adjacent to a coupling that has first and second pathways formed therein that are configured to seat a first tubing portion and a second tubing portion of an aspiration tubing coupled to the aspiration pump. The housing can also include a valve assembly that is configured to selectively pinch closed tubing disposed within one of the first pathway and the second pathway while also being configured to bias tubing disposed within the other one of the first and second pathways to an open position after the tubing is pinch closed by the valve assembly. Biasing the tubing to an open position can cause the tubing to re-conform to an open position after the tubing has been pinched to a closed position, and may prevent deformation and clogging of the tubing during use and over time.
As the pincher 232 slides in a right direction, the left side portion 232l contacts and pinches closed the second suction tube 224 as the second suction tube 224 is pinched between the anvil 234 and the left side portion 232l. At the same time, the second plunger 230 is forced to retract out of the second pathway 225 into the groove 232g and out of contact with the second suction tube 224. The first plunger 228 advances into the first pathway 223. As can be seen in
The plungers 228, 230 can be moved in a variety of ways. For example, the plungers 228, 230 can be mechanically moved through operation of a motor. A system processor can control movement of the plungers. A mechanical design controlled by software can be used.
In another embodiment, the device can include a self-cleaning mode, in which the valve assembly 200 is activated and cycles through opening and closing each of the tubes in the first and second pathways. The mode can be user activated and can use a mechanical design controlled by software.
As the cam mechanism 334 rotates about axis L, the cam mechanism 334 moves to an orientation where the cam mechanism 334 is horizontal with respect to the tubes 322, 324 and the concave side 334a and the convex side 334b each engage a tube. As seen in
As explained above with respect to the previous embodiment, the device can also have a self-cleaning mode. The mode can be user activated and can use a mechanical design controlled by software.
As the cam mechanism 434 moves linearly back and forth along axis L3 due to action of the motor 436, the triangular top 434t of the cam mechanism 434 engages each of the angled ends 406a, 408a of the plungers 406, 408 in turn to drive the plungers 406, 408 towards the pathways 423, 425, respectively. For example, as the cam mechanism 434 moves towards the second plunger 408 as seen in
As explained above with respect to the previous embodiments, the device can also have a self-cleaning mode. The mode can be user activated and can use a mechanical design controlled by software.
A selector valve may alternatively be used to prevent deformation and clogging of a tube that is pinched closed. For example, a housing can have an aspiration pump configured to couple to an aspiration tubing set, a first tubing pathway for seating a first aspiration tube of an aspirating tubing set, and a second tubing pathway for seating a second aspiration tube of an aspiration tubing set. A selector valve can be disposed on the housing and movable between multiple positions. The selector valve can have a neutral position in which the selector valve is configured to allow fluid flow through both the first aspiration tube seated within the first tubing pathway and the second aspiration tube seated within the second tubing pathway. The selector valve can also have a first position, in which the selector valve is configured to pinch the first aspiration tubing seated within the first tubing pathway to prevent the fluid flow therethrough while allowing the fluid flow through the second aspirating tubing seated within the second tubing pathway. The selector valve can further have a second position, in which the selector valve is configured to pinch the second aspiration tubing seating within the second tubing pathway to prevent the fluid flow therethrough while allowing the fluid flow through the first aspirating tubing seating within the first tubing pathway.
As the rotating arm 504 rotates the roller 506 about the central point 505, the roller 506 can be disposed at a neutral position between the tubes 522, 524, as shown in
The roller 506 can be stopped at each position, or the rotating arm 504 can rotate the roller 506 around in 360° motions for one or more cycles. A user can activate a predetermined number of cycles, causing a peristaltic effect in the tubes 522, 524 and forcing any clogged material or fluids through the tubes 522, 524. Both the roller 506 and the rotating arm 504 can rotate in either direction.
As explained above with respect to the previous embodiments, the device can also have a self-cleaning mode. A direction of the roller can be selected to push any trapped tissue up toward a waste collection bag. The mode can be user activated and can use a mechanical design controlled by software.
In another embodiment, a vibratory mechanism can be coupled to a valve configured to selectively pinch tubing closed to prevent deformation and clogging of the tubing. A housing can include an aspiration pump configured to couple to aspiration tubing, a first tubing pathway for seating a first aspiration tube of an aspirating tubing set, and a second tubing pathway for seating a second aspiration tube of the aspiration tubing set. The housing can also include the valve disposed on the housing and configured to selectively pinch tubing disposed in one of the first and second tubing pathways while allowing fluid to flow through tubing disposed in the other one of the first and second tubing pathways. The valve can include any of the valves from
The pincher can also slide to a neutral position, as shown in
While the vibrating mechanism 600 in
The devices disclosed herein can also be designed to be disposed of after a single use, or they can be designed to be used multiple times, particularly the tubing. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination, especially the tubing. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
Preferably, components of the invention described herein will be processed before use. First, a new or used instrument is obtained and if necessary cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.
Typically, the device is sterilized, particularly the tubing. This can be done by any number of ways known to those skilled in the art including beta or gamma radiation, ethylene oxide, steam, and a liquid bath (e.g., cold soak). An exemplary embodiment of sterilizing a device including internal circuitry is described in more detail in U.S. Pat. Pub. No. 2009/0202387 filed Feb. 8, 2008 and entitled “System And Method Of Sterilizing An Implantable Medical Device.” It is preferred that device, if implanted, is hermetically sealed. This can be done by any number of ways known to those skilled in the art.
One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.
