Bladder Evacuator

Abstract: A medical irrigation device (10) for alternately introducing fluid into and withdrawing fluid from a body cavity through a conduit includes a container (12) defining a fluid-receiving volume and having an open neck (32), a filter (14) disposed within the container volume for separation of tissue particles above a predetermined size from fluid introduced from the container (12) into the body, and a cap for interconnecting the open neck (32) and conduit. In an improved irrigation device, the filter (14) consists of an elongated filter element (34) disposed adjacent the open neck (32) and extending within the volume of the container (12), the filter element (34) being disposed about an axis and defining a filter opening (26) axially aligned with and spaced from the open neck (32). Application of compressional forces upon the container (12) in directions transverse to the axis of the filter element (34) urges fluid toward and through the filter element (34) substantially free of tissue particles in excess of a predetermined size, to pass through the open neck (32) into the conduit toward the body cavity. Upon release of compressional forces, the container (12) expands to withdraw unfiltered tissue-particle-bearing fluid into the container (12) via the open neck (32) and generally axially within the filter element (34) through the filter opening (26).

Description: The invention relates to a bladder evacuator according to the first part of claim 1. E. g. , in the field of urological surgery, the need frequently arises to evacuate, by flushing, pieces of solid or semi-solid material from the urinary tract, e.g., the bladder. Devices in the past have removed particles, such as stones, blood clots, pieces of tissue and the like by first introducing a sterile fluid such as saline solution into a body cavity and thereafter withdrawing the fluid to flush the particles from the body. The mixture is collected in a chamber and must be strained or filtered before the fluid is recirculated into the body cavity for collection of further particles. One particular application is flushing free-floating prostatic tissue chips from the bladder following a transurethral resectioning (TUR) procedure. A bladder evacuator according to the first part of claim 1 has become known from EP -A2- 0 254 410 (BARD LTD.). The technical problem of the invention regarding the prior art is to avoid the delay between flushing strokes required in many prior art devices in which the tissue must be allowed time to settle from the withdrawn fluid before it can be returned to the body, and also the requirement for moving parts such as flap-type check valves and the like which may become clogged. The solution to this problem is accomplished by the characterizing part of Claim 1 . As a result of the orientation of the elongated barrel of the filter, i.e., with the conduit of the neck, the filter body, and the opening at the outer end of the filter disposed coaxially along the axis of the container, tissue-carrying fluid drawn from the body flows along this unrestricted passageway into the volume of the container through the opening at the outer end of the filter. The length of the filter extending into the volume of the container, and thus the remote position of the open outer end of the filter relative to the region at the side of the container where the compressional forces are applied, results in fluid displaced by the compressional forces being directed against the outer surface of the side wall of the filter, with the fluid flowing through the small openings. Since little or none of the tissue-carrying fluid is forced to enter the outer open end of the filter, and since the small openings prevent passage of tissue pieces from the volume of the container through the sidewalls of the filter, the flushing fluid re-entering the body is relatively free of pieces of tissue. Thus by repeated squeezing and release of the container, tissue is flushed for the body and delivered into the container with the fluid, the pieces of tissue are collected in the container, and the fluid, free of tissue pieces, may then be returned back into the body for flushing additional pieces of tissue to be returned to the container. The remaining Claims go further in specifying the invention. A plurality of ways of carrying out the invention is described in detail below with reference to drawings, namely: Fig. 1 is an exploded perspective view of a bladder evacuator of the invention; Figs. 2,3,4 are side views, partially in section, of the bladder evacuator, Fig. 2 showing application of transverse compressional forces for introduction of essentially tissue-particle-free fluid into a body, Fig. 3 showing release of compressional forces to allow tissue-particle-bearing fluid to be withdrawn from the body, Fig. 4 showing the bladder evacuator briefly between release and re-application of compressional forces; and Fig. 5 is a perspective view of an alternate embodiment of the evacuator. Referring to Fig. 1, a bladder evacuator 10 of the invention for quickly and efficiently removing particles from a body cavity, e.g., prostatic tissue chips after a transurethral resectioning (TUR) procedure, consists of a squeezable, flexible container 12, a filter element 14 extending within container 12, and a connector 16. Container 12 is generally cylindrical and is sized to hold about 12 ounces of irrigation fluid. Preferably, the container is formed of resilient material, e.g., polyvinyl chloride (PVC), polyethylene or polypropylene, with a wall thickness of about 4 mm (0.156 inch), and is transparent to allow the user to monitor the fluid. At least the upper segment 18 of the container consists a squeezable, ribbed portion, preferably disposed generally coaxially with the longitudinal axis F of filter element 14. Vertical and horizontal ribs 20, 22 along the exterior surface of container 12 provide increased resiliency. Filter element 14 consists of a molded plastic cylinder open at the top 24 and having a filter opening 26 at the bottom. A flange 28 about the perimeter of the top opening is sized to rest on the top lip 30 of the neck 32 of the container 12. Filter 14 includes a screen area 34 extending generally about its circumference and along its length, having pores 36 sized to restrict throughflow of tissue chips and other particles above a predetermined size, e.g., pores 36 are approximately 0.5 to 1.0 millimeter square. Connector 16, e.g. also of plastic, has a threaded base 38 for threading onto neck 32 of container 12 and engages upon flange 28 to hold filter 14 in place. Connector 16 has upper and lower portions 40, 42 disposed at angle D (Fig. 2), e.g., about 45°, for connection to a working channel of an endoscope (not shown). The container 12 (Fig. 1) of the bladder evacuator 10 is filled with an irrigation fluid, e.g., saline solution, and assembled with the filter element 14 and connector 16. An endoscope is advanced to the surgical site as the physican observes through the viewing channel of the endoscope. Connector 16 is connected to the working channel of the endoscope to provide a conduit for fluid from the container to the site. Referring now to FIG. 2, the bladder evacuator 10 is shown during a flushing procedure, and contains fluid 50 and numerous chip 52 of tissue removed from the body. Compressional forces (arrows F c ) of at least a minimum magnitude, e.g., 1 - 2 Kp (2 to 4 lbs.), are applied to upper portion 18 of container 12 to displace the container walls 54 in region 18 from their initial dashed line position inwardly, toward axis F of filter element 14, to cause the irrigation fluid 50 to flow toward the filter and through the filter pores 36. The pores 36 are sized to restrict through-flow of tissue chips 52 above a predetermined size, and application of the compressional forces F c upon portion 18 of the container causes substantially only the fluid within the upper portion 18 of the container, between the container wall 64 and the filter surface 62 to flow directly toward the filter surface; fluid in the lower portion 66 of the container is essentially undisturbed. The fluid (arrows G) passes through the filter pores (leaving tissue chips 52 behind) and through the top opening 24 of the filter, out the open neck of the container and thereafter from opening 26 of connector 16 into the working channel of the endoscope, and therethrough into the bladder of a patient. Referring now to FIG. 3, after the walls 54 of the upper portion 18 of the container 12 are compressed to their innermost position adjacent the surface 64 of the filter element (indicated by dashed lines 68), the compressional forces (F c , Fig. 2) are released, and the resilient forces of the container (arrows F R ) cause the container walls to move outwardly, toward their original positions (dashed lines 69). The bladder evacuator and conduit are a closed system, and movement of the walls acts to withdraw the flushing fluid from within the body, carrying with it tissue chips removed in surgery. The tissue carrying fluid enters the evacuator 10 via the connector 16 to flow along the axis F of the filter, and into the container 12 through the filter opening 26 of filter element 14. (The direction and force of flow (arrows H) into the container serves to sweep a substantial portion of the tissue chips 52 from within the filter element 14, even as a small portion (arrows I) of the fluid is drawn through the pores 36 of the surface 64 of the filter. Referring now to FIG. 4, after release, (FIG. 3) and immediately before reapplication of compressional forces (FIG. 2), the container 12 is full of tissue-chip bearing fluid, typically in random movement. A short pause between cycles allows some settling of tissue chips 52, e.g., from within the volume of the filter element 14, but little, or no delay if desired, is necessary before the fluid is again forced through the pores 36 of filter 14, and the returning irrigation fluid is substantially free of tissue chips and particles above the predetermined size. The irrigation procedure can thus be carried out quickly, with little delay required between flushing strokes, and with little backflow of tissue particles into the body. Other embodiments are within the scope of the following claims. For example, bladder evacuator 10′ may have a container 12′ in the form of a right cylinder (FIG. 5).

Claims: Bladder evacuator (10) ( Fig 1 ) for alternately introducing fluid (50) into and withdrawing fluid from a bladder cavity through a conduit , comprising a container (12) for fluid defining a fluid-receiving volume and having a neck opening (32), filter means disposed within the volume of said container (12) for separation of tissue particles (52) above a predetermined size from fluid introduced from said volume through said neck opening (32), and cap means (16) for interconnecting said neck opening (32) and said conduit; an elongated filter element (14) of said filter means being disposed adjacent said neck opening (32) and extending within the volume of said container (12) and being disposed about the axis (F) of said neck opening (32) and defining two axial openings (24, 26), an upper one (24) to the neck opening (32) and a lower one (26) spaced therefrom, such that an axial passageway is defined between said two openings, said passageway functioning as a bypass, so that material flowing through said passageway does not pass through said filter element (14); said bladder evacuator (10) being adapted for application of compressional forces (F c ) ( Fig. 2 ) upon said container (12) in directions transverse to said axis (F) of said filter element (14) for urging fluid (G) within the volume of said container (12) substantially free of tissue particles (52) in excess of said predetermined size, to pass through said neck opening (32) into said conduit toward said bladder cavity, and upon release of said compressional forces (F c ) ( Fig. 3 ), said container (12) being adapted to expand to withdraw unfiltered tissue particle bearing fluid (H)into the volume of said container (12) via said neck opening (32), characterized in that said container (12) is adapted to be compressed by said compressional forces (F c ) at an upper portion (18) thereof, whereas the length of said filter element (14) extending into the volume of said container (12) is such that said lower axial opening (26) of said filter element (14) is remotedly positioned (i.e. in a lower location) relative to said upper portion (18) of said container (12) where said compressional forces (F c ) are applied, the arrangement resulting in said fluid (G) (Fig. 2) urged by said compressional forces (F c ) being directed against the outer surface of the side wall of said filter element (14), with said fluid (G) flowing through its filter pores (36), whereas upon release of said compressional forces (F c ) (Fig. 3) said unfiltered tissue particles bearing fluid (H) flows generally axially within said filter element (14) through its lower axial opening (26), by passing its said filter pores (36). Bladder evacuator of claim 1, characterized in that said container (12) comprises a generally cylindrical body portion. Bladder evacuator of claim 1, characterized in that said filter element (14) is generally cylindrical. Bladder evacuator of claim 1, characterized in that side walls of said container (12) and of said filter element (14) are substantially parallel. Bladder evacuator of claim 1, characterized in that said container (12) is comprised of resilient material . Bladder evacuator of claim 5, characterized in that said resilient material is a polymeric material selected from the group of polyvinyl chloride (PVC), polyethylene and polypropylene. Bladder evacuator of claim 1 characterized in that said cap means (16) comprises a first portion (40) extending from said open neck (32) and a second portion (42) more adjacent to said conduit , the axes of said first portion (40) and said second portion (42) defining an acute angle (D). Bladder evacuator of claim 7, characterized in that said angle (D) is of the order of about 45 ° Bladder evacuator of claim 1, characterized in that said filter element (14) comprises a mesh (34) having said filter pore openings (36) of the order of about 1 mm or less. Bladder evacuator of claim 9, characterized in that said filter pore openings (36) are about 0.5 to 1.0 mm . Bladder evacuator of claim 1, characterized in that said conduit comprises a working channel of an endoscope.

Inventors: CLEMENT THOMAS P, ROTH ROBERT A MD, CLEMENT, THOMAS P., ROTH, ROBERT A., MD
Applicants: BOSTON SCIENT CORP, ROTH ROBERT A, BOSTON SCIENTIFIC CORPORATION, ROTH, ROBERT A.
Application year: 1989
Main classification: A61H1
IPC codes: A61M1