1111111111111111 IIIIII IIIII 11111 1111111111 11111 lllll 111111111111111 11111 1111111111 11111111
`US 20050054995Al
`
`(19) United States
`(12) Patent Application Publication
`Barzell et al.
`
`(10) Pub. No.: US 2005/0054995 Al
`Mar. 10, 2005
`(43) Pub. Date:
`
`(54) SYSTEM AND METHOD FOR IRRIGATION
`AND TISSUE EVACUATION AND
`COLLECTION
`
`(76)
`
`Inventors: Winston E. Barzell, Sarasota, FL (US);
`Willet F. Whitmore, Sarasota, FL (US)
`
`Correspondence Address:
`PAUL D. BIANCO: FLEIT, KAIN, GIBBONS,
`GUTMAN, BONGINI, & BIANCO P.L.
`601 BRICKELL KEY DRIVE, SUITE 404
`MIAMI, FL 33131 (US)
`
`(21)
`
`Appl. No.:
`
`10/841,074
`
`(22)
`
`Filed:
`
`May 7, 2004
`
`Related U.S. Application Data
`
`(60)
`
`Provisional application No. 60/501,263, filed on Sep.
`9, 2003. Provisional application No. 60/555,067, filed
`on Mar. 22, 2004.
`
`Publication Classification
`
`Int. Cl.7
`(51)
`(52) U.S. Cl .
`
`...................................................... A61M 1/00
`.............................................................. 604/317
`
`(57)
`
`ABSTRACT
`
`The present invention provides a system and method for
`irrigating and collecting tissue from a body cavity in a
`patient. The system includes an irrigation and collection
`device for injecting an irrigation fluid into the body cavity.
`The irrigation device injects fluid into the body cavity by
`creating a positive pressure within the device to expel the
`irrigation fluid from the device into the body cavity. The
`irrigation fluid is evacuated from the body cavity by the
`resulting negative pressure within the device, drawing the
`irrigation fluid and any loose tissue or particulate material
`into the device. The irrigation fluid is filtered, collecting the
`evacuated tissue and particulate material in a collection
`receptacle thereby isolating the evacuated tissue and par(cid:173)
`ticulate material within the irrigation fluid.
`
`20
`
`14
`
`Imperative Care v. Inari Medical
`U.S. Patent 11,974,910
`Imperative Care Ex. 1033
`
`-1-
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`

`

`Patent Application Publication Mar. 10, 2005 Sheet 1 of 7
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`US 2005/0054995 Al
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`20
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`14
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`FIG. 1
`
`20
`
`18
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`10
`~
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`r----i-22
`
`FIG. 2
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`28
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`12
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`Patent Application Publication Mar. 10, 2005 Sheet 2 of 7
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`US 2005/0054995 Al
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`t t I
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`00000000
`00000000
`00000000
`
`28
`
`24
`
`II
`
`\
`
`28
`
`00000000
`00000000
`_.-0" 00000000 ""':::J..._
`
`I I
`........
`........
`
`00000000
`00000000
`_.-0" 0 0 0 0 0 0 0 0 ""'1-_
`00000000
`00000000
`
`_.-0" 0 0 0 0 0 0 0 0 ""':::J..._
`00000000
`
`FIG. 3
`
`00000000
`00000000
`00000000
`00000000
`00000000
`00000000
`00000000
`00000000
`00000000
`00000000
`00000000
`00000000
`
`28
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`22
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`25
`
`FIG. 4
`
`FIG. 5
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`-3-
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`Patent Application Publication Mar. 10, 2005 Sheet 3 of 7
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`US 2005/0054995 Al
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`FIG. 6
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`34
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`~ 3 0
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`40
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`45
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`32
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`FIG. 7
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`Patent Application Publication Mar. 10, 2005 Sheet 4 of 7
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`US 2005/0054995 Al
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`FIG. 8
`
`0 0 0 0 0 0 0
`0 0 0 0 0 0 0
`0 0 0 0 0 0 0
`0 0 0 0 0 0 0
`0 000000
`0 0 0 0 0 0 0
`0 0 0 0 0 0 0
`0 0 00000
`0 0 0 0 0 0 0
`0 0 0 0 0 0 0
`
`50
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`FIG. 9
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`Patent Application Publication Mar. 10, 2005 Sheet 5 of 7
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`US 2005/0054995 Al
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`P---- 60
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`80
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`73
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`72
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`82
`FIG. 10
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`FIG. 11
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`Patent Application Publication Mar. 10, 2005 Sheet 6 of 7
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`US 2005/0054995 Al
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`/ 9 0
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`102 FIG. 12
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`120
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`FIG. 13
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`Patent Application Publication Mar. 10, 2005 Sheet 7 of 7
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`/120
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`144
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`126
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`142
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`FIG. 14
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`FIG. 15
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`US 2005/0054995 Al
`
`Mar. 10, 2005
`
`1
`
`SYSTEM AND METHOD FOR IRRIGATION AND
`TISSUE EVACUATION AND COLLECTION
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`[0001] This application claims the benefit under 35 U.S.C
`§119 (e) of U.S. Provisional Patent Application No. 60/501,
`263, filed Sep. 9, 2003 and entitled SYSTEM FOR IRRI(cid:173)
`GATION AND TISSUE EVACUATION AND COLLEC(cid:173)
`TION, and U.S. Provisional Patent Application No. 60/555,
`067, filed Mar. 15, 2004 and also entitled SYSTEM FOR
`IRRIGATION AND TISSUE EVACUATION AND COL(cid:173)
`LECTION, the entirety of which are incorporated herein by
`reference.
`
`FIELD OF THE INVENTION
`
`[0002] The present invention relates to an irrigation and
`tissue evacuation and collection system and method for use
`in medical procedures.
`
`BACKGROUND OF THE INVENTION
`
`[0003] A number of medical procedures involve the irri(cid:173)
`gation of a body cavity. For example, it is necessary to
`irrigate the urinary bladder during many endoscopic urn(cid:173)
`logic procedures to flush out (and in some cases collect)
`blood clots, pieces of tissue, and the like. The general
`approach to accomplish this is to introduce a sterile saline
`solution or water into the bladder and then withdraw the
`fluid which has mixed and suspended material to be
`removed. This process needs to be repeated until the with(cid:173)
`drawn fluid becomes clear and satisfactorily free of particu(cid:173)
`late material.
`[0004] Presently, the most common device used for blad(cid:173)
`der irrigation is the Ellik evacuator. The Ellik evacuator
`consists of a clear hourglass-shaped bowl with rubber bulb
`and nozzle fitted to the upper bowl for circulating solution
`through the urethra and the bladder. The bulb is opaque and
`oriented at a right angle to the axis of the hourglass. Because
`of this, one problem with the Ellik evacuator-is the difficulty
`in fluid filling and air purging. Tissue found in the return
`flow of solution ideally is collected in the lower chamber.
`Tissue collects there due to the effects of gravity. Thus,
`another limitation of the Ellik evacuator is that the entrained
`tissue must settle by gravity into the lower chamber. As a
`result, only the particulate and tissue of a specific gravity
`greater than that of the sterile solution will settle into the
`lower chamber. The particulate in suspension in the upper
`chamber tends to be reintroduced into the bladder when the
`bulb is again compressed. Also, tissue or particulate matter
`is often sucked into the bulb regardless of specific gravity
`and because of the opacity of the bulb, tissue caught there
`cannot be visualized and may become lost. In order to
`prevent the recirculation of contaminated solution created by
`the initial irrigation with the Ellik evacuator, the surgeon
`must empty and refill the Ellik repeatedly until the final
`irrigation remains clear. In addition to this repetitive exer(cid:173)
`cise, each time the Ellik evacuator is emptied and refilled,
`the tissue that has accumulated in the irrigant must be
`filtered and removed from the basin by hand at the conclu(cid:173)
`sion of the irrigation. During this step, tissue is occasionally
`lost on the table or floor and there are significant blood and
`tissue exposure risks to operating room personnel. A final
`
`problem with the Ellik is that the rubber bulb is plugged like
`a stopper into a smooth glass tubular port. Since the neck of
`the bulb is smooth and cylindrical, there is only friction
`without mechanical advantage to hold them together. Con(cid:173)
`sequently, the bulb may easily detach from the glass con(cid:173)
`tainer inadvertently during handling with the result that the
`glass container can crash to the floor and shatter.
`
`[0005] A number of attempts have been made to improve
`upon the Ellik evacuator. These efforts include the devices
`described in U.S. Pat. Nos. 3,892,226; 4,282,873; 4,729,764,
`4,801,292; 5,338,294; and 5,421,824. In addition to their
`own unique limitations, all of the devices taught by these
`patents fail to duplicate the ideal degree and velocity of fluid
`turbulence that is generated with the Ellik evacuator. Fur(cid:173)
`thermore, none of these devices have a readily transferable
`tissue collecting mechanism. For example, in U.S. Pat. No.
`5,421,824, a squeezable portion of the container forces fluid
`from the container into the body cavity and by releasing the
`compressional forces allows the squeezable portion to
`expand and withdraw the fluid. Unfortunately, the fluid
`turbulence generated by this squeezable portion, and spe(cid:173)
`cifically the negative pressure generated when releasing the
`compressional forces, is inadequate and does not match
`those of the Ellik evacuator. Moreover, there is often leakage
`of fluid at the juncture of the container and its cap. Addi(cid:173)
`tionally, while this patent prevents particulate tissue from
`reentering the body cavity, it does not have a readily
`transferable tissue collecting mechanism and thus suffers
`from the same limitation as the Ellik evacuator in that the
`tissue collected by the device must be filtered and removed
`from the basin by hand at the conclusion of the irrigation.
`During this step, tissue is occasionally lost on the table and
`floor and there is significant blood and tissue exposure risk
`to operating room personnel in this maneuver.
`
`[0006] Thus, there remains a need for an improved irri(cid:173)
`gation and tissue evacuation and collection system.
`
`SUMMARY OF THE INVENTION
`[0007] The present invention relates to a medical irrigation
`and tissue collection system for introducing fluid into and
`withdrawing fluid from a body cavity via a fluid line. The
`system includes a container having an interior for holding
`fluid; a pump bulb in fluid communication with the container
`that may be securely attached using means other than pure
`friction; a tube having a first end portion connected with the
`fluid line and a second end portion in fluid communication
`with the interior of the container; and a collection receptacle
`for collecting particulate material. The collection receptacle
`is located within the interior of the container and removably
`connected to the second end portion of the fluid line. The
`collection receptacle is provided with a plurality of openings
`allowing the passage of fluid and particulate material smaller
`than a predetermined size.
`
`[0008]
`In one embodiment, the second end portion has a
`perforated section with a plurality of pores allowing the
`passage of fluid and particulate material of a given size. The
`relative sizes of the pores and opening can be selected as
`desired. For example, the size of the opening, on average,
`can be larger than the size of the pores, on average. Thus,
`smaller and intermediate sized particles can more readily
`move freely in and out of collection receptacle than through
`the second end portion of the tube, allowing for the collec(cid:173)
`tion of the larger size particles in the collection receptacle.
`
`-9-
`
`

`

`US 2005/0054995 Al
`
`Mar. 10, 2005
`
`2
`
`[0009] A one-way valve can be operatively associated
`with the tube allowing fluid and particulate material to flow
`through the tube and pass into the collection receptacle. The
`one-way valve can be coupled to the second end portion of
`the tube and include a length of tubing collapsible under a
`pressure differential generated by the pump bulb.
`
`[0010] The collection receptacle can be a basket made of
`a rigid polymeric material. Alternatively, the collection
`receptacle can be a mesh bag. As an alternative to the use of
`a one-way valve or as a supplement thereto, the mesh bag
`can be collapsible under a pressure differential generated by
`the pump bulb.
`
`[0011] A cap can be removably coupled to the container
`with a pump conduit having a first end portion extending
`from the cap and a second end portion coupled to the pump
`bulb. The pump conduit can extend from the cap at a right
`angle or downwardly from the cap at a non-orthogonal
`angle. In an exemplary embodiment, the container has upper
`and lower portions with the cap removably coupled to the
`upper portion and the collection receptacle located within
`the lower portion of the container.
`
`[0012] The upper and lower portions of the container can
`be configured and dimensioned such that turbulent flow
`resulting from the pressure generated by compressing the
`pump bulb is greater in the upper portion of the container
`compared to the lower portion of the container. Furthermore,
`the basket can be positioned to experience substantially no
`turbulent flow from the pressure generated by compressing
`the pump bulb. The cap can define a cap interior such that
`turbulent flow resulting from the pressure generated by
`compressing the pump bulb is substantially limited to the
`cap interior.
`
`[0013] A flow restrictor can be located between the cap
`interior and the upper portion of the container. In one
`embodiment, the flow restrictor is a lipped portion of the
`cap. In a second embodiment the flow restrictor is an
`external flange attached to the interior tube.
`
`[0014] The present invention also relates to a method of
`collecting tissue and particulate material from a body cavity
`in a patient. The method comprises positioning a medical
`irrigation and tissue collection device in fluid communica(cid:173)
`tion with the body cavity; injecting an irrigation fluid from
`the medical irrigation and tissue collection device into the
`body cavity and evacuating the irrigation fluid from the body
`cavity into the medical irrigation and tissue collection
`device. As the evacuated irrigation fluid includes tissue and
`particulate material from the body cavity, the evacuated
`irrigation fluid is filtered to isolate the tissue and particulate
`material within the irrigation fluid. The filtering is performed
`such that the tissue and particulate material of a minimum
`chosen size is collected in a collection receptacle within the
`medical irrigation and tissue collection device.
`
`[0015] The injection of the irrigation fluid from the medi(cid:173)
`cal irrigation and tissue collection device into the body
`cavity can include creating a positive pressure within the
`irrigation and tissue collection device into the body cavity.
`This creates a turbulent flow in an upper portion of the
`medical irrigation and tissue collection device while main(cid:173)
`taining a substantially turbulent free flow in a lower portion
`of the medical irrigation and tissue collection device. The
`filtering of the evacuated irrigation fluid to isolate the tissue
`
`and particulate material within the irrigation fluid can
`include collecting the tissue and particulate material in the
`lower portion of the medical irrigation and tissue collection
`device. The steps can be repeated as desired.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0016] A more complete understanding of the present
`invention, and the attendant advantages and features thereof,
`will be more readily understood by reference to the follow(cid:173)
`ing detailed description when considered in conjunction
`with the accompanying drawings wherein:
`[0017] FIG. 1 is a perspective view of an embodiment of
`the system according to the present invention;
`
`[0018] FIG. 2 is a side view of the system of FIG. 1 with
`the cap disconnected from the fluid vessel and the pump bulb
`removed;
`[0019] FIG. 3 is a sectional view of a flow limiter of the
`present invention;
`[0020] FIG. 4 is a schematic representation of the con(cid:173)
`figuration of the mesh bag during fluid in flow;
`[0021] FIG. 5 is a schematic representation of the con(cid:173)
`figuration of the mesh bag during fluid out flow;
`
`[0022] FIG. 6 is a perspective view of another embodi(cid:173)
`ment of the system according to the present invention;
`
`[0023] FIG. 7 is first exploded view of the system of FIG.
`6;
`
`[0024] FIG. 8 is a second exploded view of the system of
`FIG. 6;
`
`[0025] FIG. 9 is a cross-sectional view of the system of
`FIG. 6 showing fluid flow patterns;
`
`[0026] FIG. 10 is a perspective view of another embodi(cid:173)
`ment of the system according to the present invention;
`
`[0027] FIG. 11 is an alternative embodiment of the system
`of FIG. 10;
`
`[0028] FIG. 12 is a perspective view of another embodi(cid:173)
`ment of the system according to the present invention;
`
`[0029] FIG. 13 is a perspective view of another embodi(cid:173)
`ment of the system according to the present invention;
`
`[0030] FIG. 14 is an alternative embodiment of the system
`of FIG. 13; and
`
`[0031] FIG.15 is an exploded view showing a pump bulb
`threadably coupled to a pump conduit.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`[0032] The present invention provides a system and
`method for irrigating and collecting tissue from a body
`cavity in a patient. The system includes an irrigation and
`collection device for injecting an irrigation fluid into the
`body cavity. The irrigation device injects fluid into the body
`cavity by creating a positive pressure within the device to
`expel the irrigation fluid from the device into the body
`cavity. The irrigation fluid is evacuated from the body cavity
`by the resulting negative pressure within the device, drawing
`the irrigation fluid and any loose tissue or particulate mate-
`
`-10-
`
`

`

`US 2005/0054995 Al
`
`Mar. 10, 2005
`
`3
`
`rial into the device. The irrigation fluid is filtered to collect
`the evacuated tissue and particulate material in a collection
`receptacle.
`[0033] To repeat the process, the positive pressure is
`created within the device, expelling the irrigation fluid from
`the device into the body cavity. During the expulsion of the
`irrigation fluid, the previously collected tissue and particu(cid:173)
`late material are retained within the collection receptacle,
`such that they do not re-enter the body cavity with the
`expelled irrigation fluid. The irrigation fluid is again evacu(cid:173)
`ated from the body cavity by the resulting negative pressure
`within the device, drawing the irrigation fluid and any loose
`tissue or particulate material into the device. The irrigation
`fluid is filtered to collect the additional evacuated tissue and
`particulate material in the collection receptacle. The process
`can be repeated as desired to remove substantially all of the
`loose tissue and particulate material from the body cavity.
`[0034] Referring now to the drawing figures in which like
`reference numerals refer to like elements, there is shown in
`FIGS. 1 and 2 an irrigation and tissue evacuation and
`collection system 10 of the present invention. The irrigation
`and tissue evacuation and collection system 10 includes a
`container 12 for holding irrigation fluid. The irrigation fluid
`can be any fluid used for irrigation or lavage, such as a sterile
`normal saline solution or a sterile water solution. A pump
`bulb 14 is coupled to container 12 via a pump conduit 16.
`Although pump conduit 16 is shown as attached to container
`12, pump conduit 16 could be connected to a removable cap
`18. Cap 18 is shown as connected to container 12 by threads,
`but other coupling mechanisms could be used.
`[0035] Pump bulb 14 is made of a resilient material such
`that as pump bulb 14 is squeezed, positive pressure is
`created to force irrigation fluid from container 12. When the
`squeezing force is removed, pump bulb 14 returns to its
`non-compressed state, thereby creating negative pressure to
`draw irrigation fluid into container 12. Although pump bulb
`14 is shown frictionally connected to the pump conduit 16,
`other coupling mechanism could be used. For example, the
`pump conduit 16 can be internally (or externally) threaded,
`for threadably receiving the pump bulb 14, which would
`have corresponding threads. The mating threads may pro(cid:173)
`vide a more secure connection than a simple friction fit. This
`is beneficial since the pump bulb may be the only portion of
`the device held by the clinician. It should be noted that any
`suitable pump member could be used as an alternative to
`pump bulb 14.
`[0036] A tube 20 provides the pathway for the irrigation
`fluid into and out of container 12. Tube 20 has a first end
`coupled to a fluid line (not shown) that is insertable into the
`patient body cavity that is being treated (for example
`through the working channel of an endoscope), e.g. a
`bladder to remove prostatic tissue chips after a transurethral
`resectioning (TUR) procedure. The second end of tube 20 is
`in fluid communication with the interior of container 12. In
`this embodiment, the second end is coupled to a collection
`bag 22 via a releasable connector 24 ( e.g. an a-ring) so that
`collection bag 22 can be removed.
`
`In use, collection bag 22 is located within the
`[0037]
`interior of container 12 and is used to obtain samples of
`particulate materials. Collection bag 22 is provided with a
`plurality of openings allowing the passage of fluid and
`particulate material of a given size. The openings in the
`
`collection bag 22 have a size to restrict throughflow of
`particulate material of a predetermined size. As collection
`bag 22 can be made of a mesh type material, such as a mesh
`fabric bag, different bags having a range of mesh size
`openings can be used to suit a particular application. For
`example, if large tissue particles are desired to be collected,
`a collection bag having relatively large mesh size openings
`would be used. Also, a series of collection bags 22 could be
`used so that samples containing particles of different sizes
`could be obtained.
`[0038]
`In the manufacture of collection bag 22, the size
`and shape of the openings may not necessarily be uniform.
`This may result in a variety of shapes of the openings and a
`range of sizes of the openings (for example the cross
`sectional opening areas). Accordingly and as is customary in
`the art, the openings in collection bag 22 can be referred to
`as having an average size.
`[0039] Tube 20 also includes a filter 28 such as a fenes(cid:173)
`trated portion that allows fluid, but not particulate material,
`to circulate in and out of container 12. Filter 28 is provided
`with a plurality of pores allowing the passage of fluid and
`particulate material of a given size. The pores in filter 28
`have a size to restrict throughflow of particulate material of
`a predetermined size. Similar to collection bag 22, in the
`manufacture of filter 28, the size and shape of the pores may
`not necessarily be uniform. This may result in a variety of
`shapes of the pores and a range of sizes of the pores (for
`example the cross sectional pore area). Accordingly and as
`is customary in the art, the pores of filter 28 can be referred
`to as having an average size.
`[0040] The relative sizes of the openings (in collection bag
`22) and the pores (in filter 28) can be adjusted as desired to
`a particular clinical situation. For example, the pores on
`filter 28 can be made to have an average size that is smaller
`than the average size of the openings on collection bag 22.
`Thus, smaller and intermediate sized particles can move
`more freely in and out of collection bag 22 than through
`filter 28, allowing for the collection of the larger size
`particles in collection bag 22.
`[0041] The second end of tube 20 terminates in a flow
`limiter 26 that allows fluid (including any particulate mate(cid:173)
`rial) to pass into collection bag 22, but not back out into tube
`20. One example of a flow limiter 26 that can be used is a
`valve such as a check valve. Another flow limiter that can be
`used is a Penrose drain or other type of pliable length of
`tubing. Although a check valve may be more restrictive in
`preventing flow out of collection bag 22, the use of a pliable
`length of tubing may be beneficial in that the tubing would
`have no moving parts and is more cost efficient.
`[0042] Referring to FIG. 3, tube 20 includes a pliable
`tubing 29. When positive pressure is created within con(cid:173)
`tainer 12 to force irrigation fluid from container 12 (for
`example, by squeezing pump bulb 14), a pressure differen(cid:173)
`tial is created between the irrigation fluid within pliable
`tubing 29 and the irrigation fluid surrounding pliable tubing
`29. The irrigation fluid surrounding pliable tubing 29 has
`greater pressure then the irrigation fluid within pliable
`tubing 29, causing pliable tubing 29 to collapse within,
`effectively sealing off collection bag 22 and preventing the
`collected tissue and particulate material from re-entering the
`body cavity with the re-circulated irrigation fluid. Pliable
`tubing 29 can be provided with slits to facilitate the opening
`and closing of its lumen.
`
`-11-
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`

`

`US 2005/0054995 Al
`
`Mar. 10, 2005
`
`4
`
`[0043] When the squeezing force is removed from pump
`bulb 14, creating negative pressure, the fluid is drawn from
`the body cavity into container 12 through tube 20. The
`drawing of the irrigation fluid through tube 20 into container
`12 creates a pressure differential between the irrigation fluid
`within pliable tubing 29 and the irrigation fluid surrounding
`pliable tubing 29. The irrigation fluid within pliable tubing
`29 has a greater pressure then the irrigation fluid surround(cid:173)
`ing pliable tubing 29 causing pliable tubing 29 to expand,
`providing access to collection bag 22 to collect and isolate
`the evacuated tissue and particulate material from the irri(cid:173)
`gation fluid.
`[0044] Collection bag 22 of the present invention can also
`be made of a pliable material ( or as an alternate to pliable
`tubing). When the positive pressure is created to force
`irrigation fluid from container 12 as shown by the arrows of
`FIG. 5, a pressure differential is created between the irri(cid:173)
`gation fluid within collection bag 22 and the irrigation fluid
`surrounding collection bag 22. The irrigation fluid surround(cid:173)
`ing collection bag 22 has a greater pressure then the irriga(cid:173)
`tion fluid within collection bag 22 causing collection bag 22
`to collapse in on itself, preventing the collected tissue and
`particulate material 25 from re-entering the body cavity.
`[0045] When the squeezing force is removed from pump
`bulb 14, creating negative pressure, the fluid is drawn into
`collection bag 22 through tube 20 as shown by the arrows of
`FIG. 4. The drawing of the irrigation fluid into collection
`bag 22 creates a pressure differential between the irrigation
`fluid within collection bag 22 and the irrigation fluid sur(cid:173)
`rounding pliable collection bag 22. The irrigation fluid
`within collection bag 22 has a greater pressure then the
`irrigation fluid surrounding collection bag 22 causing col(cid:173)
`lection bag 22 to expand, providing access to collection bag
`22 to collect and isolate the evacuated tissue and particulate
`material 25 from the irrigation fluid.
`[0046]
`In use, system 10 provides a system for irrigation
`and tissue evacuation and collection for any body cavity,
`such as the bladder. Container 12 can be filled with irrigation
`fluid and the entire system can be purged of air. As is well
`known in the art, purging can be accomplished, for example,
`by submerging the opened device in a fluid filled basin and
`repeatedly compressing the bulb, or by repeatedly dipping
`the nozzle of a closed device into irrigating fluid and
`aspirating with the bulb until full. An endoscope can be used
`to advance the fluid line to the body cavity ( connected to
`tube 20) of interest.
`[0047] By compressing pump bulb 14, irrigation fluid in
`container 12 is forced through filter 28 out through tube 20
`which is connected to the body cavity via the fluid line. On
`relieving pressure on pump bulb 14, fluid is sucked back in
`from the body cavity through the fluid line and through tube
`20. Particulate tissue and other material will be trapped in
`collection bag 22 while the rest of the fluid will refill
`container 12 and pump bulb 14. When desired, collection
`bag 22 can be disconnected and dropped in a specimen jar.
`In this way, separate specimens can be accurately collected
`and submitted without the potential for specimen tissue loss
`or mix-up. In this regard, container 12 or a portion thereof
`can be made transparent or translucent so that the turbidity
`of the fluid can be visually examined.
`[0048] Referring to FIGS. 6-8, another embodiment of an
`irrigation and tissue evacuation and collection system 30
`
`according to the present invention is shown. In general, most
`of the structure and function of system 30 is like or com(cid:173)
`parable to the structure of system 10 and, accordingly the
`same name and an analogous reference numeral are used for
`like components and discussion of those like components is
`not believed necessary.
`[0049] System 30 includes a container 32 for holding
`irrigation fluid. A pump bulb 34 is coupled to a removable
`cap 38 via a pump conduit 36. Alternatively, pump conduit
`36 is attached to container 32. In contrast to conduit 16,
`conduit 36 extends downwardly at a non-orthogonal angle
`from cap 38. In addition to improved feel and handling, this
`configuration also facilitates purging of air with pump bulb
`34.
`[0050] A tube 40 provides the pathway for the irrigation
`fluid into and out of container 32. One end of tube 40 is
`removably coupled to a collection basket 42 via a connect(cid:173)
`ing tube 44. As collection basket 42 can be made of a mesh
`type material or be perforated to have an array of openings
`43, different baskets having a range of mesh size openings
`can be used to suit a particular application. If desired,
`collection basket 42 can be made of a rigid material, such as
`a suitable polymer.
`[0051] Connecting tube 44 flares outwardly to form a
`flange 46. Although flange 46 is shown as threaded to mate
`with threads on collection basket 42, other coupling mecha(cid:173)
`nisms could be used. Like collection basket 42, connecting
`tube 44 is provided with pores 45 to restrict throughflow of
`particulate material above a certain size. As was the case for
`system 10, the relative sizes (average cross sectional areas)
`of openings 43 and pores 45 can be varied to suit a particular
`application.
`[0052] Connecting tube 44 is configured and dimensioned
`and arranged with respect to conduit 36 such that the portion
`of connecting tube 44 located within and in close proximity
`to cap 38 experiences higher turbulence and flow compared
`to other portions (i.e. portions closer to flange 46). As a
`result, fluid near the base of container 32 in the vicinity of
`the bottom of collection basket 42 remains substantially
`undisturbed and substantially free of turbulent flow. This
`tends to allow material to settle in collection basket 42,
`while still providing for adequate circulation of fluid.
`
`[0053] Referring to FIG. 9, container 32 includes an upper
`portion 48 and a lower portion 50. Container 32 may be
`configured and dimensioned such that the cross sectional
`area of lower portion 50 is larger then the cross sectional
`area of upper portion 48. For example and as generally
`shown, container 32 can have a substantially frusto-conical
`shape. The configuration and dimension of container 32
`disperses the turbulent flow as the fluid travels from upper
`portion 48 to lower portion 50 of container 32. As described
`above, by compressing pump bulb 34, irrigation fluid is
`forced into container 32, creating highly turbulent flow (HT)
`in upper portion 48 of container 32. As the irrigation fluid is
`forced into lower portion 50 of container 32, the increasing
`cross section of container 32 disperses the turbulent flow,
`creating a lower turbulent flow (LT). As a result, fluid in
`lower portion 50 of container 32, in the vicinity of the
`bottom of collection basket 42, remains substantially undis(cid:173)
`turbed and substantially free of turbulent flow (NT). This
`tends to allow material to settle in collection basket 42,
`while still providing for adequate circulation of fluid.
`
`-12-
`
`

`

`US 2005/0054995 Al
`
`Mar. 10, 2005
`
`5
`
`In one embodiment, removable cap 38 defines a
`[0054]
`cap interior 52. Cap interior 52 is removably attached to
`container 32 and defines a fluid interface 54 between upper
`portion 48 of container 32 and cap interior 52. By com(cid:173)
`pressing pump bulb 34, irrigation fluid is forced into cap
`interior 52, creating highly turbulent flow (HT) in cap
`interior 52 and upper portion 48 of container 32. As the
`irrigation fluid is forced into lower portion 50 of container
`32, the increasing distance, flow restriction and, in some
`embodiments, the increasing cross sectional area of con(cid:173)
`tainer 32 disperses the turbulent flow, creating a lower
`turbulent flow (LT). As a result, fluid in lower portion 50 of
`container 32, in the vicinity of the bottom of collection
`basket 42, remains substantially undisturbed and substan(cid:173)
`tially free of turbulent flow (N1). This tends to allow
`material to settle in collection basket 42, while still provid(cid:173)
`ing for adequate circulation of fluid.
`[0055] System 30 optionally includes a flow restrictor 56,
`which partially segregates cap interior 52 from upper portion
`48 of container 32. Flow