BACKGROUND 1. Technical Field
The present disclosure relates to cooling pumps and systems and, more particularly, to peristaltic cooling pumps and/or systems typically used to circulate sterile fluids and the like to a target surgical site and/or through a surgical instrument for cooling and the like.
2. Background of Related Art
A wide variety of pump types have been used in the past for pumping any number of a variety of different liquids for any of a number of different functions and applications. Typically, a peristaltic-type pump is used in connection with many medical applications and is applied externally of the fluid delivery tube. Thus, the peristaltic pump does not interfere with the sterile state which must be maintained for the infusion fluid within the fluid delivery tube.
Many peristaltic pumps are typically used in medical, biomedical and laboratory applications, including and not limited to, irrigation devices and/or systems, suction devices and/or systems, circulation devices and/or systems, and the like. One example of a peristaltic pump is shown schematically inFIG. 1 and is described in commonly assigned U.S. Pat. No. 6,575,969, the entire contents of which are incorporated herein by reference. This so-called “cool-tip” radiofrequency thermosurgery electrode system includes an example of a pump for circulating cooling fluid.
More particularly and as seen inFIG. 1, an insulatedelectrode shaft104 with exposedtip103 is provided for insertion into a patient's body so thattip103 achieves a target volume to be ablated. A high frequency generator such as aradiofrequency generator107 is provided for supplying RF power toelectrode shaft104, as shown by the RF power P line. At the same time,electrode shaft104, is provided with a temperature sensor, provides feed back to the RF generator orcontroller circuit109 relating to a temperature reading To or multiple temperature readings of a similar nature of the tissue coolant fluid or tip arrangement. Depending upon the temperature reading, the RF output power P may be modified bycontroller109 by modulating the RF voltage, current, and/or power level, accordingly, to stabilize the ablation volume or process. If temperature rises to boiling, as indicated by temperature measurement To, the power could be either shut off or severely cut back bygenerator107 orcontroller109. Thus a feedback loop between power and temperature (or any other set of parameters associated with the lesion process) can be implemented to make the process safer or to simply monitor the process as a whole.
As further seen inFIG. 1,element108 represents the coolant fluid supply and pump system which can be configured to measure pressure and/or flow. Input flow fromelement108 toelectrode shaft104 and output flow are indicated by the arrows to and from theelectrode shaft104 andelement108, respectively. Accordingly, thecontroller109 monitors the procedure and regulates the fluid flow of the coolant betweencontroller109 andelement108 which, in turn, prevents the electrode from over heating. In conjugation, the combined mediation of flow, power, temperature, or other lesioning parameters could be integrated incontroller109, and the entire system ofgenerator107,element108, andcontroller109 can be one large feedback control network and system.Fluid bath110 may also be included with the system as a reservoir of coolant fluid which may also be regulated bycontroller109.
Typically,element108, including the pump, is an integral part ofcontrol system100. Accordingly, should the pump fail, break down, become contaminated or the like, theentire control system100 needs to be replaced or extensive work performed oncontrol system100 in order to replace, remove, sterilize, dispose and/or otherwise treat the pump ofelement108.
SUMMARY Accordingly, a need exists for improved pumps and/or systems for use with sterile fluids which overcome at least some of the deficiencies and/or drawbacks of existing pumps and/or systems. A need thus exists for improved pumps and/or pump systems that can be or are sterilized and that are used in connection with the transmission of sterile fluids.
A further need also exists for improved pumps and/or pump systems that can be selectively coupled and un-coupled to and from an ablation generator as needed and/or desired. Yet another need exists for improved pumps and/or pump systems having interchangeable components, which components may be each individually sterilizable, replaceable and/or disposable. A still further need exists for improved pumps and/or pump systems for use with cool-tip radiofrequency thermosurgery electrode system and improved pumps and/or pump systems having improved fluid management characteristics.
According to an aspect of the present disclosure, a peristaltic cooling pump system is provided and includes an actuation housing rotatably supporting a rotor assembly. The rotor assembly includes a plurality of rollers each having an axis of rotation parallel to an axis of rotation of the rotor assembly. The peristaltic cooling pump system further includes a cartridge selectively operably connectable to the actuation housing. The cartridge is configured to operatively support a tube. The tube is made of a resilient and selectively compressible material. Accordingly, when the cartridge is connected to the actuation housing the tube is in operative association with at least one roller of the rotor assembly.
The cartridge may include a supporting body having a pair of spaced apart arms, wherein a first arm defines a lumen formed near a free end thereof and a second arm defines a passage formed near a free end thereof, wherein the tube is extendable across the pair of arms when the tube is operatively associated with the cartridge.
The lumen formed near the free end of the first arm may be configured and dimensioned to slidably engage the tube when the tube is positioned therein. The passage formed near the free end of the second arm may be configured and dimensioned to fixedly engage the tube when the tube is positioned therein.
The peristaltic cooling pump system may further include a plurality of dividing walls spaced along a length of the rollers. The dividing walls define pumping regions therebetween. A plurality of cartridges may be provided for operative engagement, one each, into a respective pumping region. Each pumping region may be sized to accommodate a different sized tube. Accordingly, each cartridge may have an occlusion surface having a different diameter.
The actuation housing may be configured to support a plurality of cartridges thereon. Each cartridge may accommodate a tube having a different cross-sectional dimension.
The peristaltic cooling pump system may further include a fluid reservoir management system containing a quantity of fluid therein. The fluid reservoir management system is fluidly connected to an inlet and an outlet of the tube. The fluid reservoir management system may include a first reservoir fluidly connectable to an inlet of the tube; a second reservoir fluidly connectable to an outlet of the tube; and a diaphragm separating the first and second reservoirs. In use, prior to the operation of the peristaltic cooling pump system the first reservoir may contain all of the fluid and the second reservoir contains no fluid. Further, during operation of the peristaltic cooling pump system the fluid may travel from the first reservoir, through the tube, to the second reservoir. The diaphragm may be configured to move to contract the first reservoir and expand the second reservoir as fluid is flowing therebetween.
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 is a schematic diagram of a prior art cool-tip control system for RF heating ablation showing an RF generator, coolant system, fluid bath source and control system that monitors and regulates critical parameters relating to temperature, power and fluid flow;
FIG. 2 is a schematic plan view of a cartridge according to an embodiment of the present disclosure;
FIG. 3 is a partially broken away side elevational view illustrating an installation of the cartridge ofFIG. 2 into an actuation housing according to an embodiment of the present disclosure;
FIGS. 4-6 are perspective schematic views of a peristaltic cooling pump system according to an embodiment of the present disclosure, shown at various stages of loading and operation;
FIG. 7 is a schematic plan view of a fluid reservoir management system for use with the peristaltic pump system ofFIGS. 4-6;
FIG. 8 is a cross-sectional view of the fluid reservoir management system ofFIG. 7, as taken through line8-8 ofFIG. 7;
FIG. 9 is a schematic perspective view of a peristaltic pump system according to an alternate embodiment of the present disclosure;
FIG. 10 is an elevational view of a cartridge for use with the peristaltic pump system ofFIG. 9; and
FIG. 11 is side, elevational view of the peristaltic pump system ofFIG. 9 illustrating the operative engagement of the cartridge ofFIGS. 9 and 10 thereto.
DETAILED DESCRIPTION The presently disclosed sterilizable pumps and systems, together with attendant advantages, are best understood by reference to the following detailed description in conjunction with the figures.
Referring again toFIG. 1, a prior art control system for RF heating ablation is shown generally as100.Control system100 includes aninsulated electrode shaft104 having an exposedtip103 for insertion into a patient's body such that exposedtip103 can achieve a target volume to be ablated.Electrode shaft104 extends from ahub106 and includes at least one mechanical interface (not shown) for connectingelectrode shaft104 toRF generator107 and coolant supply and pump108.
RF generator107 supplies RF power toelectrode shaft104, as shown by the RF power connection “P”. At the same time,electrode shaft104 which includes a temperature sensor (not shown), feeds temperature information back toRF generator107 and/or acontroller circuit109 relating to a temperature reading To or multiple temperature readings of the tissue coolant fluid or tip arrangement. According to the temperature reading, any modulation of the RF output power “P” is accorded bycontroller109. More particularly,controller109 modulates the RF voltage, current, and/or power level to stabilize the ablation volume or process. If temperature reading To rises to a boiling point, the power is either shut off or severely cut back togenerator107 bycontroller109. Thus a feedback loop between power and temperature (or any other set of parameters associated with the lesion process) can be implemented to monitor the overall process.
In addition, as seen inFIG. 1,control system100 further includes power measurement connections fromRF generator107 tocontroller109 and a feedback power control signal fromcontroller109 toRF generator107. The entire heating process may be preconfigured by the operator before the procedure based on the imaging and preplanned calculations of ablation volume verses the tip geometry and other ablation parameters. Thus,controller109 is capable of regulating the entire heating process by controlling the RF power “P” fromgenerator107.
With continued reference toFIG. 1,control system100 further includes a coolant fluid supply andpump system108 with potential thermo-monitoring, pressure monitoring, flow monitoring, etc. Input flow from coolant fluid supply andpump system108 toelectrode shaft104 and output flow from the electrode shaft are indicated by the arrows which connecthub106 and the coolant fluid supply andpump system108. Such input and output flow can be monitored by appropriate pressure or flow monitoring elements or detection devices (not shown). These are well known in the fluid control industry. Accordingly, the fluid flow and the temperature of the coolant can be fed back betweencontroller109 andcoolant supply108 so thecontroller109 can regulate the input and output flow. Combined regulation mediation of flow, power, temperature, and/or other lesioning parameters may also be integrated incontroller109, thegenerator107, and thecoolant supply108. Thecontroller109 may also be configured as one large feedback control network and system.
Control system100 may also include a reservoir ofcoolant fluid110 which may have possible interior temperature regulation within the fluid bath. Bath temperatures and control signals are fed back and forth tocontroller system109. These parameters also could be integrated in the overall control of the ablation process. Indwelling controllers, electronics, microprocessors, or software may be included to govern the entire process or allow preplanned parameters to be configured by the operator based on the selection of a tip geometry and overall ablation volume which are typically selected according to a tumor or pathological volume to be destroyed. Many variants or interconnections of the block diagram shown inFIG. 1 or additions of the diagram could be devised by those skilled in the art of fluid control power and regulation systems.
Turning now toFIGS. 2 and 3, acartridge300, according to an embodiment of the present disclosure, is shown and described.Cartridge300 is configured and adapted for use with aperistaltic pump system200, as will be described in greater detail below.Cartridge300 includes a clevis-like supportingbody302 having a pair of upstanding spaced apartarms304,306.First arm304 includes alumen308 formed in afree end304athereof.Lumen308 is configured and dimensioned to permit tube “T” to slide therewithin.Second arm306 includes apassage310 formed in afree end306athereof.Passage310 is configured and dimensioned to engage tube “T” when tube “T” is properly positioned therewithin such that tube “T” is fixed in position. Tube “T” may be fixed withinpassage310 in any suitable manner, such as with a suitable adhesive.
As seen inFIG. 3, in one embodiment,arms304,306 have an ovular cross-sectional profile. As such,arms304,306 are inserted into anopening310aof anactuation housing202. Once a particular arm is inserted intopassage310a,thecartridge300 is rotated approximately 90° such that the long axis of the arm cross-sectional profile is substantially aligned with a longitudinal axis of apouch310b.In so doing, an arm is thus substantially fixed in position withinpouch310b.
Cartridge300 functions to hold tube “T” in position during connection with the remainder ofperistaltic pump system200, such that a user does not have to hold tube “T”.
Turning now toFIGS. 4-6, aperistaltic pump system200 is shown, in accordance with an embodiment of the present disclosure, for use incontrol system100 and withcoolant supply108.Pump system200 includes arotor assembly220 rotatably supported on anactuation housing202.Actuation housing202 may include a drive mechanism (e.g., a drive motor or the like) which is adapted for delivering either forward or reverse rotation torotor assembly220. As will be described in greater detail below,rotor assembly220 functions to repetitively compress tube “T” in order to squeeze fluid contained within tube “T” therefrom and to create or produce a volumetric pumping effect through tube “T”.
As seen inFIGS. 4-6,rotor assembly220 includes a plurality ofrollers222 rotatably supported at the free ends of a frame (not shown). The axis of rotation of eachroller222 is parallel to an axis of rotation “X” ofrotor assembly220. For example, eachroller222 may be supported near a free end of a spoke, which spoke is secured or otherwise operatively connected to a rotational drive shaft of the drive mechanism (not shown). Accordingly, in use, as the shaft of the drive mechanism is rotated, therollers222 rotate in a planetary orbit around rotational axis “X” ofrotor assembly220.
While only tworollers222 are shown inFIGS. 4-6, three, evenly spaced apart rollers may be provided.Rotor assembly220 may be provided with any number ofrollers222 or may be provided with any other appropriate structure for accomplishing the volumetric pumping effect desired.
As seen inFIGS. 4-6,pump system200 further includescartridge300, as described above, operatively supported byactuation housing202 and operatively engagable withrollers222 ofrotor assembly220.Actuation housing202 includes aframe330 that defines anannular recess332 defining anocclusion surface334 formed in a surface thereof.Occlusion surface334 offrame330 is configured and dimensioned for operative association withrollers222 ofrotor assembly220 and with a section of tube “T” (i.e., the section of tube “T” disposed betweenarms304,306 of cartridge300).Occlusion surface334 offrame330 may include agroove334aextending along the length thereof which is configured and dimensioned to at least partially receive the portion of tube “T” therein.Occlusion surface334 may extend for approximated1800.
As seen inFIGS. 4-6 and described above inFIG. 3,cartridge300 is mounted toactuation housing202 such that tube “T” is placed into operative engagement betweenrollers222 ofrotor assembly220 andocclusion surface334 offrame330. Tube “T” may be fabricated from an elastomeric material that allows for tube “T” to be compressed betweenrollers222 andocclusion surface332 and that returns to its un-compressed condition when not betweenrollers222 andocclusion surface332.
With continued reference toFIGS. 4-6,pump system200 is further provided with an engagingmechanism240 configured and adapted to moveactuation housing202 toward and away fromrotor assembly220 to thereby secure tube “T” therebetween and to vary the flow rate of fluid through tube “T”. As seen throughFIGS. 4-6, rotation of engagingmechanism240, in the direction of arrow “A” about the rotational axis “X”, results in the movement ofactuation housing202 towardrotor assembly220. Likewise, rotation of engagingmechanism240, in the direction opposite to arrow “A” about the rotational axis “X”, results in the movement ofactuation housing202 away fromrotor assembly220.
As seen inFIG. 4, with tube “T” operatively supported incartridge300,cartridge300 is mounted toactuation housing202 such thatcartridge300 is spaced a distance away fromrotor assembly220. Withcartridge300 mounted to actuationhousing202 and tube “T” positioned betweenframe330 androtor assembly220, engagingmechanism240 is rotated, in the direction of arrow “A”, to approximateactuation housing202 towardrotor assembly220.Engaging mechanism240 is rotated an amount sufficient to securely clamp tube “T” betweenframe330 androtor assembly220, as seen inFIG. 5.
With reference now toFIGS. 5 and 6, the use of engagingmechanism240 to control of the rate of fluid flow through tube “T” is shown.Engaging mechanism240 includes anindicator242 which illustrates the degree of the rate of fluid flow through tube “T”. In use, the greater the amount ofindicator242 that is visible the greater the rate of fluid flow through tube “T”. Accordingly, as seen inFIG. 5, a relatively small amount ofindicator242 is visible and thus a relatively small rate of fluid will flow through tube “T”. As seen inFIG. 6, a relatively larger amount ofindicator242 is visible and thus a relatively greater rate of fluid will flow through tube “T”.
Adjustment of the rate of fluid flow through tube “T” is accomplished by further rotation ofengagement mechanism240 about the rotational axis “X”, in the direction of arrow “A”. The greater the degree of rotation ofengagement mechanism240 about the rotational axis “X”, the moreactuation housing202 is approximated towardrollers222 ofrotor assembly220 and the greater the degree of compression of tube “T” byrollers222 ofrotor assembly220 againstocclusion surface334 offrame330. In operation, the greater the degree of compression of tube “T” betweenrollers222 ofrotor assembly220 againstocclusion surface334 offrame330 the greater the rate of fluid flow through tube “T”.
In operation, when fluid “F” is pumped through tube “T”, fluid “F” is pumped to the operative site (i.e., to electrode shaft104) to thereby maintain the operative site at a substantially constant temperature during the surgical procedure.Engagement mechanism240 may be provided with tactile feedback structure (not shown), which provides the user with sensory feedback during the rotation ofengagement mechanism240 about the rotational “X” axis.
Turning now toFIGS. 7 and 8, a fluid reservoir management system for use with the peristaltic pump system ofFIGS. 2-6 (or any of the pump systems disclosed herein), is shown and is generally designated as400.Fluid management reservoir400 includes a pair ofbladders410 and420 each defining a chamber orreservoir412 and422, respectively. Arespective nozzle414,424 is operatively connected to eachbladder410,420 for providing access to each chamber orreservoir412,422. Valves430a,430bare fluidly connected to eachnozzle414,424, respectively, and provide selective opening and closing ofbladders410,420.
Chambers orreservoirs412,422 are fluidly separated from one another.Bladders410,420 may be fabricated from any material known by one having skill in the art, including and not limited to pliable, flexible and/or elastomeric materials; rigid, non-flexible materials or any combinations thereof.
A first end of tube “T” is connectable tonozzle414 offirst reservoir412, through valve430a,while a second end of tube “T is connectable tosecond reservoir422, through valve430b.Prior to operation or use of fluidreservoir management system200first reservoir412 offirst bladder410 is filled with a fluid, such as distilled or sterile water, whilesecond reservoir422 ofsecond bladder420 is empty. In use, aspump system200 is in operation, fluid “Fout” is drawn out offirst reservoir412 and communicated through tube “T” passing throughpump system200, and fluid “Fin” is deposited intosecond reservoir422.Pump system200 also delivers fluid to the target surgical site before returning the fluid to thesecond reservoir422.
Effectively,fluid management reservoir400 is a single use-type reservoir. Once the initial fluid contained withinfirst reservoir412 is completely used and deposited withinsecond reservoir422,fluid management reservoir400 is replaced with a new fluid management reservoir.
Fluid management reservoir400 includes adiaphragm450 separatingfirst reservoir410 fromsecond reservoir420. In operation, as fluid flows fromfirst reservoir412 tosecond reservoir422, thereby emptyingfirst reservoir412 and fillingsecond reservoir422,diaphragm450 moves fromsecond reservoir422 towardfirst reservoir412 thereby constrictingfirst reservoir412 and expandingsecond reservoir422.
Turning now toFIGS. 9-11, a peristaltic pump system in accordance with another embodiment of the present disclosure, for use incontrol system100 and withcoolant supply108, is shown generally as500.Pump system500 includes arotor assembly520 rotatably supported on anactuation housing202.Actuation housing202 may include a drive mechanism (e.g., a drive motor or the like) which is adapted for delivering either forward or reverse rotation torotor assembly220. As will be described in greater detail below,rotor assembly220 functions to repetitively compress at least one tube “T” in order to squeeze fluid contained within the tube(s) “T” therefrom and create or produce a volumetric pumping effect through tube(s) “T”.
As seen inFIGS. 9 and 11,rotor assembly520 includes a plurality ofrollers522 extending fromactuation housing202.Rollers522 are rotatably connected to actuationhousing202 in such a manner so as to rotate about a central axis of rotation “X” forrotor assembly520. Eachroller522 may define an axis “Xn” of rotation which is parallel to axis of rotation “X” ofrotor assembly520. For example, eachroller522 may be operatively supported inactuation housing202 in such a manner thatrollers522 are rotatable about the central rotational “X” axis, and eachroller522 is rotatable about their respective longitudinal axes “Xn”.
While only threerollers522 are shown inFIG. 9,rotor assembly520 may include any suitable number ofrollers522 or may include any other appropriate structure.
As seen inFIGS. 9 and 11,pump system500 includes a plurality of dividingwalls526 disposed along the length ofrollers522. Each dividingwall526 is provided with anaperture526athrough whichrollers522 extend. In this manner, a plurality of pumpingregions528 are defined between dividingwalls526. Dividingwalls526 are supported onactuation housing202 by a beam, arm or the like204 extending fromactuation housing202.
As seen inFIGS. 9-11,pump system500 further includes at least onecartridge530 which is selectively, and operatively positionable in pumpingregions528.Cartridge530, when positioned in pumpingregion528 resides in operative engagement withrollers522 ofrotor assembly520.Cartridge530 includes anannular recess532 which defines anocclusion surface534 formed in a surface thereof.Occlusion surface534 ofcartridge530 is configured and dimensioned for operative association withrollers522 ofrotor assembly520 and with a section of tube “T”.Occlusion surface534 may extend for approximated 180°.
Eachcartridge530 is configured and adapted for engagement in any of pumpingregions528. In particular, eachcartridge530 includes alocking element536b(seeFIGS. 10 and 11) that is configured and adapted for selective snap-fit engagement in acomplementary locking feature526b(seeFIG. 11) provided in dividingwalls526.Cartridge530 may be pivotally connected to dividingwalls526 by way of apivot pin536a(seeFIG. 10) or the like.Cartridge530 may also be provided with a finger tab536cfor facilitating movement ofcartridge530 between a position in whichocclusion surface534 is in close cooperative arrangement withrollers522 and a second position in whichocclusion surface534 is in spaced non-cooperative arrangement withrollers522.
In operation, when tube “T” is positioned in apumping region528 and arespective cartridge530 is moved to a close cooperative arrangement withrollers522, fluid may be pumped through tube “T” and to the operative site (i.e., to electrode shaft104) to thereby maintain the operative site at a substantially constant temperature during the surgical procedure.
In accordance with the present embodiment, a plurality of tubes “T” may be placed inrespective pumping regions528 andrespective cartridges530 may be used to operatively engage tubes “T” and create a pumping action through the tubes “T” as therotor assembly520 is rotated. In this manner, a plurality of different cooling paths or circuits are defined, more particularly, a plurality of discrete fluid paths are defined. In other words, the fluid from one cooling path does not mix with the fluid from another fluid path.
Tubes “T” of varying diameters may be placed intovarious pumping regions528 in order to pump varying volumes of fluid at varying rates. Dividingwalls526 may be spaced by varying amounts in order to define pumpingregion528 of varying sizes which in turn can accommodate tubes “T” of various sizes. Accordingly, it is envisioned thatcartridges530 must be provided in varying sizes to cooperate and complement the sizes of thepumping regions528.
Additionally,occlusion surface534 ofcartridge530 may have a relatively larger or smaller diameter depending on the size of tube “T” which is being used. For example, if a relatively larger diameter tube “T” is being used, acartridge530 having anocclusion surface534 with a relatively larger diameter will be used. Likewise, if a relatively smaller diameter tube “T” is being used, acartridge530 having anocclusion surface534 with a relatively smaller diameter will be used.
Cartridges530 may be provided with tactile feedback structure (not shown) which provides the user with sensory feedback during the connection and/or placement ofcartridges530 into pumpingregions528.
As seen inFIG. 10,pump system500 may include alatch structure540 or the like for locking and maintainingcartridge530 into position betweenwalls526 and against tube “T”.
Although illustrative embodiments of the present disclosure are described herein, the disclosure is not limited to those embodiments, and various other changes and modifications may be affected therein by one skilled in the art without departing from the scope or spirit of the disclosure. All such changes and modifications are intended to be included within the scope of the present disclosure.