JP2020054731A - Bodily fluid drainage system with volume limiting and adjustable volume capacity functionality - Google Patents

Abstract

To provide an improved bodily fluid drainage system including a collection vessel and a mechanical volume limiting mechanism to prevent overfill of the collection chamber, where the volume capacity of the collection chamber is adjustable.SOLUTION: In an improved volume limiting bodily fluid drainage system, a proportion of volume within a collection chamber 10' taken up by a rack-and-pinion volume limiting mechanism 90, 95 is minimized and not susceptible to malfunction in the event of exposure to bodily fluid, and the volume capacity of the fluid collection chamber is adjustable.SELECTED DRAWING: Figure 1A

Description

  The present invention relates to drainage systems, and more particularly, to implantable systems for drainage of bodily fluids such as cerebrospinal fluid (CSF). More specifically, the present invention relates to an improved bodily fluid drainage system having volume limiting and volume capacity adjusting functions.

  During treatment for medical disorders, it is not uncommon to need to remove excess fluid from the body. One common use of such a fluid drainage system is in the treatment of hydrocephalus, the accumulation of CSF surrounding the brain. Under normal conditions, the rate at which CSF is produced is approximately equal to the rate at which it is absorbed by the body. Any excess accumulation of SCF when this rate is no longer equal will result in an undesirable increased intracranial pressure (ICP) that exceeds the normal physiological maximum pressure limit. During the treatment of hydrocephalus, a shunt is typically implanted in fluid communication with the ventricle to allow drainage of the CSF at a desired rate. It is important to maintain a proper drainage flow rate. On the other hand, too fast a flow rate (overdrainage) can result in severe headaches or collapse of one or more ventricular cavities in the brain. However, on the other hand, a flow rate that is too slow (under drainage) can result in undesirable intracranial pressures that can cause brain damage.

  The flow or drainage speed of the CSF is adjustable via a programmable valve having a plurality of different pressure settings. Desirably, such programmable pressure settings are non-invasively adjustable after implantation into the body. In this way, the pressure setting can be controlled over the period when the drainage system is implanted in the body and the necessary adjustments must be made. For example, Codman & Shuttleff, Inc., including a CODEMAN® HAKIM® programmable controllable valve (US Pat. No. 6,049,045) or a CERTAS® programmable controllable valve (US Pat. The commercially available implantable valves marketed by R & D Inc. are each incorporated herein by reference in their entirety. In these external drainage systems, CSF is drained from the body into an external collection chamber. The external drainage system drains bodily fluids from the patient through a drainage catheter into an external sterile collection container (eg, a bag) into which fluid is collected. Thus, such an external drainage system is a "closed" collection system (ie, in which body fluids are not exposed to bacteria in room air). Overfilling of the collection container can undesirably leak fluid from the closed collection system, resulting in wet conditions (eg, when the filter gets wet by bodily fluids), resulting in operational errors, and / or when the fluid is in room air. If they become exposed to the bacteria, they will result in the possibility of infection in the drainage system.

  Of course, visual monitoring of the level of collected bodily fluids is one way to prevent such overfilling of the collection container, but this is usually done at a predetermined time that is always under care. It requires one-on-one monitoring by health care professionals who cannot be devoted to only one of the patients. Therefore, it is desirable to develop an overfill prevention system for a bodily fluid drainage system that does not require continuous visual monitoring by a medical professional.

  U.S. Patent No. 6,064,064 is directed to a volume-limited bodily fluid drainage system with a buoyant float hingedly connected to the top of a collection chamber. The levitating float member has a lumen filled with air, gas, or other levitating material. This float member occupies a volume of about 10 ml to about 15 ml in the collection chamber. The collection chamber lumen is configured to have a volume approximately equal to or slightly greater than the volume of the float member plus a predetermined volume. The volume of the collection chamber exceeds the sum of the volume of the float member and the predetermined volume by about 2 ml to about 10 ml. As a result, this patented float member undesirably occupies a large volume in the collection chamber, leaving only a small percentage of the volume of the collection chamber for collected fluid, or otherwise draining from the float member and the patient. It requires a very large collection chamber that is large enough to accommodate the total volume required for both the volume of fluid to be liquefied.

  Also, the configuration in U.S. Pat. No. 6,073,838 requires that the float member be designed at its top to include a hollow chimney-like extension with a pressure equalization hole at the top. Such pressure equalization holes communicate with air inside the float member lumen so that gas under pressure flows into and out of the float member lumen through the pressure equalization holes. Enable. The pressure equalization holes equalize the pressure between the inside and outside of the float member during sterilization under pressure, thereby preventing damage to the float member during the sterilization process. The hollow chimney-like extension is specifically intended to position the equalization holes above the level of the collected fluid in the collection chamber at a sufficiently high level so that the fluid (eg, CSF) ) Does not exit the float member lumen under normal operating conditions. Due to the fact that the buoyant float member is filled with air, gas, or other buoyant material, fluids that affect the buoyancy, thereby affecting the proper overfill prevention function, cause fluid to enter the float chamber lumen. It is important to avoid entering. In this way, the volume of fluid that can be collected in the device of US Pat. No. 6,037,075 is not only dependent on the overall volume of the float member, but also as required, as described in the preceding paragraph. A hollow chimney-like design with a hole at the top, which must prevent fluid from entering, is also disadvantageously limited. Also, this patented assembly is limited solely to prevent overfilling and does not allow for adjustment of the volumetric capacity of the collection chamber itself.

U.S. Pat. No. 4,595,390 U.S. Pat. No. 8,322,365 U.S. Pat. No. 8,221,366

  Accordingly, it is desirable to develop an improved volume-limited fluid drainage system that minimizes the proportion of volume in the collection chamber occupied by the volume-limited mechanism and is less prone to failure in the event of exposure to fluid. Further, it would be desirable to develop an improved bodily fluid drainage system in which the volume capacity of the fluid collection chamber is adjustable in addition to the overfill prevention feature.

  The improved SCF drainage system of the present invention includes an overfill prevention mechanism that automatically activates when a preset amount of fluid enters the collection chamber, increasing patient safety and otherwise manually Reduce workload on hospital staff who must monitor levels frequently.

  One aspect of the present invention is directed to an implantable bodily fluid drainage system that includes a collection container and a mechanical volume limiting mechanism to prevent overfilling of the collection chamber. In contrast to conventional mechanisms, the mechanical volume limiting mechanism of the present invention is less prone to failure even when immersed in bodily fluids.

  Another aspect of the drainage system of the present invention relates to a collection container having an outer collection chamber and an inner collection chamber, wherein the inner collection chamber is axially movable within the outer collection chamber. The mechanical volume limiting mechanism includes a bent movable arm rotatably disposed within the inner collection chamber and substantially supported at its center by a hinge relative to a fixed support arm. Including. The stopper head is located at one end of the bent movable arm, and the pinion gear is located at the opposite end of the bent movable arm. A rack gear mounted on the inner surface of the inner collection chamber engages a pinion gear that rotates a movable arm bent about a hinge. As bodily fluid accumulates in the inner collection chamber, the inner collection chamber moves axially downward relative to the outer collection chamber, while the pinion gear on the bent movable arm engages the rack gear, whereby Raise the stopper head upwards, finally closing the inlet port of the outer collection chamber.

  Yet another aspect of the invention relates to an implantable bodily fluid drainage system having an adjustable volumetric volume adjustment mechanism for varying the maximum volumetric volume of the inner collection chamber. The adjustable volumetric volume adjustment mechanism includes a coil spring disposed within the outer collection chamber, the coil spring having a spring tension in the absence of an externally applied axial force. The adjustable volumetric capacity adjustment mechanism further includes a spring force adjustment mechanism for generating an externally applied axial force to change the spring tension of the coil spring. Increasing the spring tension of the coil spring increases the volume capacity of the inner collection chamber, while decreasing the spring tension of the coil spring decreases the volume capacity of the inner collection chamber. In one configuration, the spring force adjustment mechanism includes a threaded shaft inserted through a hole defined in the bottom surface of the outer collection chamber. A first end of the threaded shaft is located inside the outer collection chamber, while an opposing second end of the threaded shaft is located outside the outer collection chamber. . There is a support plate on the first end of the threaded shaft, while a knob is located on the second end of the threaded shaft. A coil spring is disposed between the bottom surface of the inner collection chamber and the support plate. The knob is located on the second end of the threaded shaft.

Yet another aspect of the invention is directed to an implantable bodily fluid drainage system that includes a resistance adjustment mechanism located at an inlet port of a collection chamber. The resistance adjustment mechanism is provided with a luer fitting and a selection guide housed in a side slot defined during the luer fitting and having a plurality of openings of varying diameter defined therein. including. The selection guide can slide within the side slot in a direction perpendicular to the axial direction of the luer fitting, whereby a desired one of the plurality of openings of the selection guide is defined through the luer fitting. Aligned with lumen. Alternatively, the resistance adjustment mechanism can be configured to include a luer fitting and a collar having a plurality of openings each having a different diameter defined therein.
The collar is rotatable such that a desired one of the plurality of openings is aligned with the defined lumen through the luer fitting.

  In another aspect of the invention, an implantable bodily fluid drainage system includes a gravity shutoff valve located at an inlet port of a collection container. The gravity shut-off valve is also provided by (i) a first ball bearing fixed in a complementary first hemispherically shaped recess by a first compression spring and (ii) a second compression spring. A second ball bearing is secured within the complementary second hemispherically shaped recess. The second ball bearing is spaced a predetermined distance from the first ball bearing in the direction of body fluid flow. First and second compression springs compress the first and second ball bearings, respectively, in directions 180 ° opposite each other along an axis perpendicular to the direction of fluid flow through the gravitational shutoff valve. Each of the first and second hemispherically-shaped recesses is configured to permit the passage of bodily fluid into each of the linear paths that slope downward at about 45 ° with respect to an axis perpendicular to the direction of fluid flow through the gravity shutoff valve. Transitions in the direction of flow. After each of the first and second hemispherically shaped recesses in the direction of fluid flow through the gravity shut-off valve, the axial passage of the valve is provided with first and second ball bearings respectively. It is narrowed to prevent it from passing through.

  Another feature of the invention is a movable arm formed from three branches, wherein the collection container includes a main collection chamber, and the mechanical volume limiting mechanism has a terminal end and opposing ends sharing a common intersection. And an implantable bodily fluid drainage system. The first end of the first branch of the movable arm is rotatably mounted on the inner surface of the main collection chamber via a hinge. The stopper head and the levitation member are each located at the end of the remaining two branches of the movable arm. The flotation member rises simultaneously with the level of fluid in the main collection chamber. Eventually, the stopper head seats in the inlet port of the main collection chamber and closes the inlet port to prevent overfilling of the main collection chamber. The movable arm can be T-shaped or Y-shaped.

  In yet another aspect of the invention, an implantable bodily fluid drainage system having a mechanical volume limiting mechanism includes a central flotation member disposed inside a collection container having an inlet port defined on a top surface of the collection container. . The central levitation member has an opening defined axially therethrough. A stopper head mounted on the upper surface of the central flotation member is axially aligned with the inlet port of the collection container. A shaft attached to the bottom surface of the collection container extends axially upward toward the top surface of the collection chamber with the shaft passing through an opening defined in the central flotation member. The radial cross section of the opening in the central levitation member and the radial cross section of the shaft are complementary and non-circular.

  Yet another aspect of the invention is directed to an implantable bodily fluid drainage system, wherein the collection container is configured as a two-part nested design comprising an upper housing tubular section and a lower housing tubular section. Each of the upper and lower housing tubular sections has an open end and an opposing closed end. The open end of the lower housing tubular section is nested within the open end of the upper housing section. Complementary teeth that physically contact each other are located on each mating surface of the upper and lower housing sections. Disposed between the mating surfaces of the upper and lower housing sections is an O-ring. The volume capacity of the collection container is adjustable by moving the lower housing tubular section axially relative to the upper housing tubular section.

  Yet another aspect of the invention is directed to an implantable bodily fluid drainage system having a volume limiting mechanism that includes a flexible tube having a fixed end and an opposing free end. The fixed end of the flexible tube is inserted into an inlet port defined on the top surface of the collection container, while the free end of the flexible tube extends into the collection container. Fluid passes through a defined lumen axially through the flexible tube. A flotation member is disposed about the free end of the flexible tube, and the flotation member rises in the axial direction simultaneously with the fluid level of bodily fluids stored in the collection container. At some point as the levitation member rises, the flexible tube bends to form a kink that tapers the flow of bodily fluid through it. Finally, the bend in the flexible tube forms an angle ≤ 90 °, blocking all flow of fluid therethrough.

  The foregoing and other features of the invention will be readily apparent from the following detailed description and drawings which illustrate illustrated embodiments of the invention, wherein like reference numerals are used throughout the several views. Refer to the components of.

FIG. 2 is a partial cross-sectional view of a first embodiment having a rack and pinion overfill prevention mechanism and a coil spring actuated volumetric capacity adjustment function, including a portion of a bodily fluid drainage system according to the present invention, wherein the drainage system is open. is there. FIG. 1B is a partial cross-sectional view of the first embodiment of FIG. 1A with the drainage system in a closed state. FIG. 9 is a side view of the exemplary configuration of the luer lock of FIG. FIG. 2B is a top view of the luer lock of FIG. 2A. FIG. 9 is a side view of another exemplary configuration of the luer lock of FIG. FIG. 2C is a top view of the luer lock of FIG. 2C. FIG. 9 is a partial cross-sectional view of the exemplary gravity cutoff valve of FIG. FIG. 11 is a partial cross-sectional view of a second embodiment having a T-shaped hinged levitation member overfill prevention mechanism in a single main collection chamber, with the inlet port in an open state. FIG. 4B is a partial cross-sectional view of the second embodiment of FIG. 4A, with the inlet port in a closed state. Partial cross section of a third embodiment with a Y-shaped hinged flotation member overfill prevention mechanism for increased volumetric capacity and a multi-stage auxiliary collection chamber, comprising part of a bodily fluid drainage system according to the invention In the figure, the inlet port is closed by the stopper head after filling the main chamber. FIG. 5B is a partial cross-sectional view of the third embodiment of FIG. 5A, wherein after the main chamber has been completely filled, each valve of the auxiliary chamber has been opened to increase the volumetric capacity, and the inlet port has additional fluid. Has been resumed to be able to collect. FIG. 11 is a partial cross-sectional view of a fourth embodiment having a central levitation member overfill prevention mechanism and a two-part nested collection chamber configuration to provide volumetric capacity adjustment, comprising a portion of a bodily fluid drainage system according to the present invention; The drainage system is open. FIG. 6B is a sectional view taken along the line VI-VI in FIG. 6A. FIG. 13 is a partial cross-sectional view of a fifth embodiment having a kink tube volume limiting mechanism and a two-part nested collection chamber configuration to provide volumetric capacity adjustment functionality, comprising a portion of a bodily fluid drainage system according to the present invention, wherein the drainage system comprises: It is open. FIG. 7B is an enlarged view of a portion of the kink tube as indicated by dashed circle VII in FIG. 7A, with the drainage system in a closed state. FIG. 4 is a partial side view of an improved drainage system according to the present invention.

  The volume limiting and volume adjusting mechanisms of the present invention are used as part of an implantable drainage system for draining bodily fluids such as CSF.

  FIG. 1A is a partial cross-sectional view of a first embodiment with a rack and pinion volume restriction mechanism and a coil spring volume capacity adjustment feature for use in an implantable bodily fluid drainage system. The implantable bodily fluid drainage system includes a pair of collection chambers (one of which includes an outer collection chamber 10 having a top surface 5, an opposing bottom surface 3, and a sidewall 7 extending therebetween to form a closed outer container. Are nested within each other). Disposed within the outer collection chamber 10 is an inner collection chamber having a corresponding top surface 5 ', an opposing bottom surface 3', and sidewalls 7 'extending therebetween to form a closed inner container. 10 '. The inner collection chamber 10 ′ is smaller in size than the outer collection chamber 10. The collection chambers 10, 10 ′ are preferably made of a transparent material, and the inner collection chamber 10 ′ is preferably provided by a number associated with some, but not all, marks (eg a numerical indication provided every 5 ml). It has a series of volumetric identification marks or lines in predetermined small units (eg, 1 ml increments). The top surface 5 of the outer collection chamber 10 has an associated inlet port or opening 15 defined therethrough, while the top surface 5 'of the inner collection chamber 10' is It has an associated inlet port or opening 15 'defined therethrough. The two inlet ports 15, 15 'in the outer and inner collection chambers 10, 10', respectively, are substantially aligned (but need not be of equal diameter) to be implanted at a target location in the body. The bodily fluid drained from the catheter passed through the respective inlet ports 15, 15 'is finally collected in the inner collection chamber 10'. Fluid does not collect in the outer collection chamber 10 outside the inner collection chamber 10 '. Thus, under proper operation, all bodily fluids from the implanted catheter are collected only in the inner collection chamber 10 '.

  Attached to the inner surface of one of the walls 7 of the outer collection chamber 10 is a minimum travel limiting stop spaced a predetermined distance (D) from each other in the longitudinal direction of the chamber 10. ) 100 and a maximum travel limiting stop 105. Each travel limiting fastener 100, 105 may be a rib, protrusion, or other shaped protrusion that extends radially inward into the interior of the outer collection chamber 10 and preferably substantially perpendicular to the sidewall 7. It is formed. Attached along the outer surface of the side wall 7 ′ of the inner collection chamber 10 ′ is preferably away from the inner collection chamber 10 ′, for example, toward a rib, a protrusion, or toward the inner surface of the side wall 7 of the outer collection chamber 10. Is an axial movement guide 110, such as another shape of protrusion that extends radially outwardly substantially perpendicular to the side wall 7 '. The axial movement guide 110 is positioned or trapped axially between the minimum travel limit stop 100 and the maximum travel limit stop 105. Accordingly, axial movement of the axial movement guide 110 causes axial movement or movement of the inner collection chamber 10 ′ with respect to the outer collection chamber 10 between the minimum movement limit stop 100 and the maximum movement limit stop 105. Restrict or restrict. The axial movement guide 110 is designed to engage the minimum and maximum movement limit stops 100, 105, thereby opening and closing the inlet port or opening 15 so that the outer collection chamber of the inner collection chamber 10 '. Regulate axial movement or movement relative to 10. Disposed laterally through the wall 7 of the outer collection chamber 10 between the maximum travel limiting stop 105 and the minimum travel limiting stop 100 is a bypass switch or valve 115, which is Valve 115 is maintained in a locked open or open position as a safety feature in case of overfilling of inner collection chamber 10 '.

  The inlet opening or port 15 of the outer collection chamber 10 is adapted to allow fluid to flow through the inlet opening or port 15 and into the inner collection chamber 10 ′ by means of a rack and pinion mechanically operated stopper head. Opened to allow and closed to obstruct. A fixed support arm 75, attached at one end to the inner surface of the top surface 5 of the outer collection chamber 10, passes through the inlet port or opening 15 'into the inner collection chamber 10'. It extends substantially vertically into the interior of the chamber 10. Hinge 17 located at the opposite end of fixed support arm 75 substantially supports movable arm 80 about center so that movable arm 80 swings or rotates about hinge 17. Enable. The movable arm 80 has a bent or curved configuration at an angle α, preferably 90 ° <α. The pinion gear 90 is arranged at one end of the movable arm 80, while the stopper head 85 is configured at the opposite end of the movable arm 80. Stopper head 85 has both a size and shape that is complementary to the size and shape of inlet port 15 so that passage of fluid through the inlet port when the stopper head is seated at the inlet port. Is hindered. The pinion gear 90 operatively engages a complementary linear rack gear 95 located on the inner surface of the side wall 7 'of the inner collection chamber 10'. In FIG. 1A, the inlet port or opening 15 of the outer collection chamber 10 is open so that bodily fluids can pass therethrough. As fluid accumulates in the inner collection chamber 10 ′, the inner collection chamber 10 ′ moves axially downward relative to the outer collection chamber 10. Due to the axial movement of the chambers 10, 10 'relative to each other, the pinion gear 90 moves along the linear rack gear 95, and then the movable arm 80 swings or rotates about the hinge 17 and the stop head 85 Is raised toward the inlet port or opening 15 of the outer collection chamber 10. FIG. 1B shows the rack and pinion volume limiting mechanism of FIG. 1A, with a stopper head 85 seated in the inlet port or opening 15 of the outer collection chamber 10, thereby passing through the fluid inlet port or opening 15. The inlet port or opening 15 is closed for the passage of the gas.

  Opposite the top surface 5 'of the inner collection chamber 10' is a bottom surface 3 'having an outlet port or opening 25 defined therein. A tubing 30 insertable into the outlet port or opening 25 and securable into the outlet port or opening 25 via a fitter, plug, or adapter 35 is an inner collection. The fluid collected in chamber 10 'is supplied to an external drainage bag 45 or other external collection container (FIG. 8). An externally manually operated on / off stopcock or valve 40 located along the tube 30 can be used to regulate the flow of fluid through the tube 30.

  Referring to FIG. 1A, the volumetric capacity of the fluid that can be collected in the inner collection chamber 10 ′ is required in accordance with the present invention via a coil spring 70 axially compressed by a mechanical spring force adjustment mechanism 50. It is mechanically adjustable or controllable (increase / decrease) accordingly. The exemplary spring force adjustment mechanism 50 illustrated in this first embodiment of FIG. 1A includes a threaded shaft 55, wherein the threaded shaft 55 is one of the threaded shafts 55. And a knob or dial 65 (preferably of a larger diameter with respect to the threaded shaft 55) located at the opposite end of the threaded shaft 55. Have. The coil spring 70 is disposed between the bottom surface 3 'of the inner collection chamber 10' and the support plate 60.

  The threaded shaft 55 extends the bottom surface 3 of the outer collection chamber 10 so that the support plate 60 is located within the outer collection chamber 10 while the knob or dial 65 is located outside the outer collection chamber 10. Through a slightly larger diameter hole 20 defined therethrough. Knob 65 and support plate 60 preferably have a larger diameter than hole 20 so as to impede passage therethrough. One or more tactile indicators 56, such as bumps, protrusions, ribs, or recesses, on the lower surface of knob or dial 65 that are substantially parallel to the bottom surface of outer collection chamber 10 or face the bottom surface of outer collection chamber 10 Are preferably arranged. Rotation of knob or dial 65 increases / decreases the volumetric capacity of inner collection chamber 10 ', depending on the direction of rotation (e.g., clockwise or counterclockwise). By way of example only, illustrated, clockwise / counterclockwise rotation of knob or dial 65, respectively, provides the maximum volume level of fluid in inner collection chamber 10 'by tactile indicator 56. Also, each increase / decrease by a predetermined amount (for example, 50 ml) in finer or smaller predetermined increments.

  In operation, increasing the spring tension (ie, compression) of the coil spring 70 increases the inner collection chamber 10 ′ before the force exerted by the pooled fluid exceeds the opposing reaction force exerted by the compressed coil spring 70. Increases the volume capacity of bodily fluids stored therein. Thus, the inner collection chamber 10 'only moves or moves axially downwards towards the bottom 3 of the outer collection chamber 10. In particular, clockwise rotation of the knob or dial 65 causes the support plate 60 to rise axially upward in the outer collection chamber 10 toward the top surface 5. As the support plate 60 moves upward in the axial direction, the strength of the external force applied to the coil spring 70 increases, and the spring tension of the coil spring 70 increases (that is, the spring tension increases). In this compressed state, the force exerted by the pooled volume of fluid exceeds the opposing force exerted by the compressed coil spring 70, and thus causes a larger volume of fluid to flow through the inner collection chamber before acting in opposition. 10 ′, allowing the inner chamber 10 ′ to move axially downward relative to the outer collection chamber 10. As the volume of fluid collected in the inner collection chamber 10 ′ further increases, the inner collection chamber 10 ′ is lowered axially relative to the outer collection chamber 10 to move the pinion gear 90 downward along the rack gear 95. The stopper head 85 at the opposite end of the movable arm 80 is swung or rotated upward around the hinge 17. Eventually, the inner collection chamber 10 'is moved longitudinally (lowered) so that the stopper head 85 seats in the inlet port or opening 15, thereby preventing overfilling.

  On the other hand, when the knob or dial 65 rotates counterclockwise, the support plate 60 moves longitudinally downward toward the bottom surface 3, thereby reducing the external force applied to the coil spring 70 (ie, the coil spring 70 Is less relaxed, less compressed and reduces spring tension). With the coil spring 70 in this more relaxed (i.e. less compressed) state, the force exerted by the pooled fluid exceeds the reduced opposing external force exerted by the coil spring 70 and, therefore, before the fluid reacts. Can be stored in the inner collection chamber 10 ′, allowing the inner chamber 10 ′ to move axially downward relative to the outer collection chamber 10. As the volume of fluid stored in the inner collection chamber 10 'further increases, the inner collection chamber 10' is moved longitudinally (down) relative to the outer collection chamber 10, thereby causing the pinion gear 90 to move. Move downward along the rack gear 95, and swing or rotate the stopper head 85 at the opposite end of the movable arm 80 upward around the hinge 17. Eventually, the inner collection chamber 10 'is lowered sufficiently so that the stopper head 85 seats and closes in the inlet port or opening 15, preventing overfilling of the chamber.

  Thus, before the inner collection chamber 10 'begins to move longitudinally downward, thereby engaging the rack and pinion gear adjustment mechanism, the compression of the coil spring 70 via the spring force adjustment mechanism 50 causes the inner collection chamber to compress. Increase the amount of fluid that can be stored in 10 '. Alternative configurations of the spring adjustment mechanism 50 for controlling the spring tension (ie, the degree of compression / relaxation) of the coil spring 70 are contemplated within the intended scope of the present invention.

  4A and 4B illustrate a second embodiment of the volume limiting mechanism according to the present invention. Instead of the coil spring pinion design according to the embodiment in FIGS. 1A and 1B, the alternative configuration in FIGS. 4A and 4B employs a hinged or rotating levitation member. In this embodiment, a T-shaped arm 190 is rotatably mounted on the collection chamber 200 about a hinge 193. The stopper head 160 and the levitating member 195 are respectively located at opposite ends of the top of the T-shaped arm 190. Stopper head 160 has a size and shape that is complementary to inlet port or opening 205. This second embodiment, shown in FIGS. 4A and 4B, differs from that already shown and described in that only a single main collection chamber 200 is provided instead of the nested inner and outer collection chambers. They differ in that they are not. Initially, when there is no fluid in the main collection chamber 200, the T-shaped arm 190 swings or rotates down around the hinge 193 so that the inlet port or opening 205 is Released to receive fluid through section 205 (FIG. 4A). Prior to the level of fluid reaching the levitating member 195, the T-shaped arm 190 is preferably on a stop member 201 mounted on the inner surface of the collection chamber 200. The stop member 201 ensures upward movement of the T-shaped arm in a direction toward the inlet port or opening 205 with increasing fluid levels. The levitation member 195 may be used to move the main collection chamber 200 until the stopper head 160 eventually seats inside the entrance port or opening 205 to close the entrance port or opening 205 and prevent overfilling of the main collection chamber 200. It rises simultaneously with the level of fluid in 200 (FIG. 4B).

  A third hinged levitation volume limiting mechanism of the present invention is illustrated in FIGS. 5A and 5B. In this embodiment, a Y-shaped arm 190 'is formed from three branches having a common intersection. The first end of the first branch of the arms 190 '(opposing the common intersection) is rotatably mounted via hinges 193 to a fixed support arm 75'. A fixed support arm 75 'is mounted on the inner surface of the top surface of the collection chamber. At the ends (opposed to the common intersection) of the remaining two branches of the Y-shaped arm 190 ', a stop head 160 and a levitating member 195 are arranged respectively. Stopper head 160 has a size and shape that is complementary to inlet port or opening 205. This third embodiment, shown in FIGS. 5A and 5B, differs from that already shown and described in that only a single main collection chamber 200 is provided instead of the nested inner and outer collection chambers. Not different in that. Initially, when there is no fluid in the main collection chamber 200, the Y-shaped arm 190 'swings or rotates down around the hinge 193 so that the inlet port or opening 205 is Opened to receive fluid through opening 205. The levitation member 195 may be used to move the main collection chamber 200 until the stopper head 160 eventually seats inside the entrance port or opening 205 to close the entrance port or opening 205 and prevent overfilling of the main collection chamber 200. It rises simultaneously with the level of fluid in 200 (FIG. 5A). One or more auxiliary collection chambers 210, 210 'can be provided in communication with a single main collection chamber 200 to increase the volumetric capacity, i.e., to increase the maximum amount of fluid that can be collected. Each auxiliary collection chamber 210, 210 'has an associated shutoff valve 215, 215'. Manually opening the shut-off valves 215, 215 'allows additional fluid to flow from the main collection chamber 200 into the first auxiliary collection chamber 210, thereby collecting the overall maximum volumetric capacity of the fluid. be able to. If additional storage capacity is required, as shown in FIG. 5B, the shutoff valve 215 ′ of the second auxiliary collection chamber is opened to allow fluid to flow from the first auxiliary collection chamber 210 to the second auxiliary collection chamber 210. Can flow into the auxiliary collection chamber 210 '. Although only two auxiliary collection chambers 210, 210 'are shown in FIGS. 5A and 5B, any number of one or more auxiliary collection chambers can be employed as desired.

  FIG. 6A shows yet another embodiment of a volume limiting mechanism of a centered levitation member 195 'to prevent overfilling. As in the embodiment in FIGS. 5A and 5B, this embodiment also has a single collection chamber 200 ′, but in this embodiment, the single collection chamber 200 ′ comprises an upper housing tubular section 202 and a lower housing tubular section. It is configured as a two-part nested design with a compartment 203, each of the upper and lower housing tubular compartments 202, 203 having an open end and an opposing closed end. The open end of lower housing tubular section 203 is nested within the open end of upper housing tubular section 202. Complementary teeth 220 are disposed on mating surfaces of the upper and lower housing tubular sections 202, 203, respectively, and physically engage each other. An O-ring or other type of seal 225 is disposed between the mating surfaces of each of the upper and lower housing tubular sections 202,203. Thus, the maximum volume capacity of a single collection chamber 200 'can be increased / decreased by sliding the lower housing tubular section 203 down / up relative to the upper housing tubular section 202. A single centered flotation member 195 ', preferably in the shape of a disk, is located within a single collection chamber 200'. Protruding, preferably substantially vertically, from the top surface of the levitation member 195 'toward the top surface 5 "of the single collection chamber 200' is vertically / axially aligned with the inlet port or opening 205. The stopper head 160 has a complementary size and shape to the inlet port or opening 205. The central shaft or shaft 230 has a central opening defined in the levitation member 195 '. The central axis 230 has a preferably non-circular cross-section in a direction perpendicular to the axial direction, while the central opening 235 defined in the levitation member 195 'is complementary. 6B, the central axis 230 has a keyed cross section (eg, a notch “K”), while the central opening 235 defined in the levitation member 195 ′ is This key-shaped non-circular cross-sectional configuration of both the shaft 230 and the corresponding opening 235 prevents rotation of the levitating member 195 'about the shaft 230, thereby providing a stopper head. Ensure that the section 160 is always properly aligned with the single collection chamber 200 '. The levitation member 195' rises simultaneously with the level of fluid in the single collection chamber 200 '. , The stopper head 160 seats in the inlet port or opening 205 to close the inlet port or opening 205, thereby allowing the passage of fluid into a single collection chamber 200 ′ and a single This prevents overfilling of the collection chamber 200 '.

  A final embodiment of the present invention is a kinked tubing design for a volume limiting function, as shown in FIGS. 7A and 7B. As shown and described in the embodiment in FIG. 6A, the embodiment in FIGS. 7A and 7B also has a two-part nested design with an upper housing tubular section 202 and a lower housing tubular section 203. With one collection chamber 200 ', each of the upper and lower housing tubular sections 202, 203 has an open end and an opposing closed end. The open end of the lower housing tubular section 203 is nested within the open end of the upper housing section 202. Complementary teeth 220 are located on each mating surface of the upper and lower housing sections 202, 203, which physically engage each other. An O-ring or other type of seal 225 is disposed between the mating surfaces of the upper and lower housing sections 202,203. Accordingly, the maximum allowable volume capacity of a single collection chamber 200 'can be increased / decreased by sliding the lower housing tubular section 203 down / up relative to the upper housing tubular section 202.

  The flexible tube 240 is secured at one end into an inlet port or opening 205, while its opposing free end 245 is connected to and secured to a single collection chamber without any connection. Extend inside. The free end 245 of the flexible tube 240 is open. Attached or secured to the free end 245 of the flexible tube 240 is a flotation member 195 "such as a cylindrical washer. The flotation member 195" is a single collection chamber 200 '. It rises simultaneously with the level of fluid in it. Eventually, the level of fluid in the single collection chamber 200 'will bend the flow of fluid into the tapered titration through the inlet port or opening 250 as the flexible tubing 240 bends. It rises to the point where it forms the reducing kink 250, and ultimately completely shuts off all flow with sufficient lifting of the levitation member 195 "(the kink in the flexible tube 240 reduces the acute angle θ≤90 °). When formed, the volume restriction mechanism discussed above (ie, the overfill protection mechanism) itself does not provide any restriction to fluid flow (ie, the inlet port or opening is open or In contrast to the embodiment where the flexible tubing is closed, the flexible tubing 240 prevents the flexible tubing 240 from fully interrupted and reduced flow (the flexible tubing 240 is bent to an angle θ ≦ 90 °). (Fig. 7 B) to create a restricted, tapered or weening fluid flow. As the levitation member 195 ″ is raised or raised, the flexible tube 240 The material is selected such that it can bend to an angle θ ≦ 90 ° without any additional external force and the length of the flexible tube 240 is sufficiently long. Preferably, the flexible tube 240 is made of a biocompatible material and has a length appropriate for the size of the collection chamber to allow operation of the collection chamber. Also, the flexible tube 240 is intentionally designed during manufacture to include a small bend or kink prior to assembly in the drainage system, such that the flexible tube 240 is It is envisaged to ensure that the "" rises with the level of fluid in a single collection chamber 200 '.

  FIG. 8 is a partial side view of an improved drainage system according to the present invention, and for simplification of the drawings only, one or more collections for each embodiment, as described in detail in the preceding paragraph. The chamber is generally represented by a single rectangular collection container 300. The particular configuration of one or more collection chambers for each of the embodiments can be replaced by a generally represented rectangular collection container 300. For any of the embodiments described above, the collection chamber preferably incorporates some backup safety features, such as a hydrophobic filter 120 and / or a bypass valve 115. The hydrophobic filter 120 on the top surface 5 of the outer collection chamber 10 must undesirably contact fluid drained during overfilling of the collection chamber, a sterile interior portion of the components of the drainage system of the present invention. Reduce the risk of contamination. A bypass switch or valve 115 can be provided in the collection chamber of any of the embodiments of the drainage system described herein. The bypass switch is maintained in a locked open state or position as an additional safety feature in case of overfilling of the collection chamber in which the fluid is stored.

  Not only can the volume capacity of the inner collection chamber 10 'be adjusted or controlled according to the present invention, but also the flow rate of bodily fluids entering the collection chamber can be varied as needed. The fluid flow rate can be controlled or adjusted using the resistance adjustment mechanism 125 (FIG. 8) in any of the foregoing embodiments in accordance with the present invention. FIGS. 2A and 2B are side and top views of a first embodiment of the resistance adjustment mechanism in FIG. 8 including a luer fitting 130 and a selection guide 135 housed in a side slot 132 of the luer fitting 130. Is shown. In the illustrated exemplary embodiment, the selection guide 135 has three openings (145 ', 145 ", 145'") of varying diameter. One of the openings (145 ', 145 ", 145'") has the selection guide 135 in the direction perpendicular to the axial direction of the luer fitting 130 (as indicated by the directional arrow), with the desired diameter opening. Selection is made by sliding until alignment with a single uniform axial lumen 140 of luer 130. Any one or more different sized diameter openings can be integrated on a single selection guide 135 and differently distinct sets of guides can be combined into separate guides within the set. It can be used with different diameter openings associated therewith. An alternative embodiment of the resistance adjustment mechanism 125 is illustrated in FIGS. 2C and 2D, including a fitting luer 130 'and a rotatable collar 135'. As shown in the top view of FIG. 2D, the collar 135 'can be designed to have a plurality of openings (145', 145 ", 145 '"), each with a different diameter. In the example shown in FIG. 2D, three different sized openings (145 ', 145 ", 145'") are provided. Any number of openings of one or more diameters having different diameters can be employed. The desired flow rate of the fluid is such that the collar 135 is such that the desired sized diameter openings (145 ', 145 ", 145'") are aligned with the axial lumen 140 defined in the luer fitting 130 '. Controlled by rotating '.

  In use, the implantable drainage system of the present invention can be used by a patient when the support column from which the collection chamber is suspended tilts, tilts, crouches, tilts, tilts sideways, or turns over completely. Extreme movement may cause possible leakage of fluid from the inner or outer collection chambers 10 ', 10. From a predetermined angle (e.g., about 45 [deg.]) With respect to the tilting, tilting, leaning, sloping, and listing of the vertical axis perpendicular to the floor on which the support pillar stands. Large or equivalent tilting, tilting, tilting, sloping, listing of a support post (with collection chambers 10, 10 'suspended therefrom) can occur of fluid from the inner or outer collection chambers 10', 10 Presumed to be a risk for leakage. FIG. 3 is an enlarged sectional view of the gravity cutoff valve 141 of FIG. A gravity shut-off valve 141 located at the inlet port or opening 15 of the outer collection chamber 10 tilts when the support post (and the collection chambers 10, 10 'suspended therefrom) tip. When tilting, leaning, sloping, listing, or even falling, a desired angle relative to the angle of the vertical axis perpendicular to the floor on which the support post stands (e.g., (45 °) to provide additional safety features to prevent or minimize fluid leakage from the inner and outer collection chambers (10 ′, 10).

  Referring to the enlarged cross-sectional view of FIG. 3, the gravity shutoff valve 141 includes a first ball bearing 150 and a second ball bearing 150 ′ separated from each other by a predetermined distance in the axial direction of the luer fitting 130. . The first ball bearing 150 is fixed in a complementary hemispherical recess 151 by a first compression spring 153 oriented perpendicular to the axial direction of the luer fitting 130. The hemispherically shaped recess 151 is formed through the luer fitting 130 into a linear path 152 having a downward slope defined by an angle β that is preferably about 45 ° with respect to a horizontal axis (perpendicular to the axial direction of the luer fitting 130). Transitions downward in the direction of fluid flow in. In a similar manner, the second ball bearing 150 'is fixed in a complementary hemispherical recess 151' by a second compression spring 153 '. The hemispherically shaped recess 151 'transitions downward in the direction of fluid flow into a linear path 152', which is preferably inclined at about 45 [deg.] With respect to the horizontal axis (perpendicular to the axial direction of the luer fitting 130). In the luer fitting 130, on the downstream side (in the flow direction of the fluid) following each of the hemispherical concave portions 151, 151 ', the axial passages 154, 154' are provided with the first and second ball bearings 150, 150 ', respectively. It is narrowed to prevent it from passing. The first and second compression springs 153, 153 'compress the first and second ball bearings horizontally in 180 ° opposing directions to support the support pole (and suspended therefrom in two different corresponding directions). Any possible tilting, tilting, tilting, sloping, or listing of the collected chambers 10, 10 '). Unwanted or undesired tilts, tilts, tilts, sloping, listings, or falls of the support poles from which the collection chambers 10, 10 'are suspended by more than a predetermined angle (e.g., about 45 [deg.]) May be caused by a respective Produce a force exerted by one of the ball bearings 151, 151 'to balance the force exerted by the compression springs 153, 153'. As a result, one of the ball bearings 151, 151 'rolls down the associated linear path 152, 152' and seats in the associated narrow passage 154, 154 'to prevent fluid leakage. I do.

  Advantageously, the mechanical volume limiting mechanism according to the invention does not interact with the electromagnetic field and is therefore less prone to interference and malfunction.

  Also, the resistance adjustment mechanism 125 and / or the gravity shut-off valve 141 may be used in any of the described and illustrated embodiments, in conjunction with any of the described and illustrated embodiments, which is an aspect of the present invention. Within the intended range.

  Thus, while the basic novel features of the invention have been illustrated, described, and pointed out as applied to the preferred embodiment, it is to be understood that both the carrying and details of the illustrated apparatus and in its operation. It will be understood that various omissions, substitutions and alterations may be made by those skilled in the art without departing from the spirit and scope of the invention. For example, it is expressly intended that all combinations of components and / or steps that perform substantially the same function and in substantially the same way to achieve the same result are within the scope of the present application. . Substitutions from one described embodiment of components to other embodiments are also fully contemplated and contemplated. It is also understood that the drawings are not necessarily drawn to scale and are merely conceptual in nature. Accordingly, the invention is limited only by the following claims.

  All patents, pending patent applications, publications, journal articles, books, or other references cited herein are hereby incorporated by reference.

3, 3 'bottom surface 5, 5' top surface 7, 7 'side wall 10 outer collection chamber 10' inner collection chamber 15, 15 'inlet port 17 hinge 20 hole 25 outlet port, opening 30 tube 40 on / off stopcock, valve 45 external drainage bag, external collection container 50 mechanical spring force adjusting mechanism 55 shaft 56 indicator 60 support plate 65 knob, dial 70 coil spring 75 support arm 75 'support arm 80 movable arm 85 stopper head 90 pinion gear 95 rack gear 100 Minimum movement limit stopper 105 Maximum movement limit stop 110 Axial movement guide 115 Bypass valve 120 Hydrophobic filter 125 Resistance adjustment mechanism 130 Luer fitting 130 'Fitting luer, luer fitting 132 Side slot 135 Selection guide 135' Collar 140 In the axial direction Cavity 1 1 Gravity shutoff valve 145 ', 145 ", 145'" Opening 150 First ball bearing 150 'Second ball bearing 151, 151' Recess 152, 152 'Linear path 153 First compression spring 153' Second Compression springs 154, 154 'Axial passage 160 Stopper head 190, 190' Arm 195, 195 ', 195 "Floating member 193 Hinge 200 Main collection chamber 200' Collection chamber 201 Stop member 201
202 Upper housing tubular section 203 Lower housing tubular section 205 Inlet ports, openings 210, 210 ′ Auxiliary collection chambers 215, 215 ′ Shut-off valve 220 Teeth 225 Sealant 230 Central axis, shaft 235 Central opening 240 Flexible tube 245 free end

Claims (15)

An implantable bodily fluid drainage system,
A collection container,
A mechanical volume limiting mechanism to prevent overfilling of the collection chamber;
With
An implantable bodily fluid drainage system characterized in that the mechanical volume limiting mechanism is less likely to fail even when immersed in the bodily fluid. The collection container,
An outer collection chamber having a top surface, an opposing bottom surface, and sidewalls extending between the top surface and the bottom surface, wherein the top surface of the outer collection chamber has an entrance defined therethrough. An outer collection chamber having a port; and an inner collection chamber having a top surface, an opposing bottom surface, and sidewalls extending between the top surface and the bottom surface, wherein the inner collection chamber is disposed within the outer collection chamber. Wherein the top surface of the inner collection chamber has an entrance port defined therethrough, wherein the entrance port of the inner collection chamber and the entrance port of the outer chamber. The inner collection chamber being aligned;
With
The inner collection chamber is axially movable within the outer collection chamber;
The mechanical volume limiting mechanism,
A fixed support arm attached to the inner surface of the outer collection chamber;
A curved movable arm rotatably disposed in the inner collection chamber and supported at its center by the hinged support arm, the stopper head having one of the curved movable arms. A bent movable arm, which is disposed at an end, and a pinion gear is disposed at an opposite end of the bent movable arm,
A rack gear on the inner surface of the inner collection chamber, the rack gear engaging the pinion gear and mounted to rotate the bent movable arm about the hinge;
With
As the bodily fluid accumulates in the inner collection chamber, the inner collection chamber moves axially downward with respect to the outer collection chamber, while the pinion gear on the bent movable arm connects to the rack gear. 2. The implantable bodily fluid drainage system according to claim 1, wherein the system engages, thereby raising the stopper head upward, and ultimately closing the inlet port of the outer collection chamber. A volume capacity adjustment mechanism for changing a maximum volume capacity of the inner collection chamber;
The volume capacity adjustment mechanism,
A coil spring disposed in the outer collection chamber, the coil spring having a spring tension in the absence of an externally applied axial force;
A spring force adjusting mechanism for externally generating an axial force to change the spring tension of the coil spring;
With
The increased spring tension of the coil spring increases the volume capacity of the inner collection chamber, while the reduced spring tension of the coil spring decreases the volume capacity of the inner collection chamber. Item 3. The implantable bodily fluid drainage system according to Item 2. The spring force adjusting mechanism,
A threaded shaft inserted through a hole defined in the bottom surface of the outer collection chamber, wherein a first end of the threaded shaft is disposed inside the outer collection chamber; A threaded shaft, wherein the opposite second end of the threaded shaft is disposed outside the outer collection chamber;
A support plate disposed on the first end of the threaded shaft, wherein the coil spring is disposed between the bottom surface of the inner collection chamber and the support plate. The implantable bodily fluid drainage system according to claim 3, comprising: a support plate; and a knob disposed on the second end of the threaded shaft. A maximum travel limiting stop and a minimum travel limiting stop, wherein the maximum travel limiting stop and the minimum travel limiting stop project from an inner surface of the wall of the outer collection chamber. Restriction stop;
An axial movement guide protruding from an outer surface of the wall of the inner collection chamber, wherein the axial movement of the inner collection chamber in the outer collection chamber includes the maximum movement limit stop and the minimum movement limit stop; 3. The implantable bodily fluid drainage system according to claim 2, further comprising an axial travel guide limited by movement of the axial travel guide during.   Further comprising a resistance adjustment mechanism located at the inlet port of the collection chamber, the resistance adjustment function comprising a luer fitting and a selection guide housed in a side slot defined in the luer fitting. Wherein the selection guide has a plurality of openings of varying diameter defined in the selection guide, the selection guide extending through the side slots in a direction perpendicular to an axial direction of the luer fitting. The method of claim 1, wherein the slide guide is slidable such that a desired one of the plurality of openings of the selection guide is aligned with a lumen defined through the luer fitting. Implantable bodily fluid drainage system.   The device further comprises a resistance adjustment mechanism disposed at the inlet port of the collection chamber, the resistance adjustment mechanism including a luer fitting and a collar, wherein the collar has a plurality of openings defined therein, each having a different diameter. The implant of claim 1, wherein the collar has a desired one of the plurality of openings aligned with a lumen defined through the luer fitting. Possible body fluid drainage system. Further comprising a gravity shut-off valve disposed at an inlet port of the collection container, wherein the gravity shut-off valve comprises:
A first ball bearing fixed in a complementary first hemispherical recess by a first compression spring;
A second ball bearing spaced a predetermined distance from the first ball bearing in a direction of the body fluid flow, wherein the second ball bearing is supplemented by a second compression spring by a second compression spring; And the first and second compression springs respectively move the first and second ball bearings perpendicular to the direction of fluid flow through the gravity shut-off valve. A second ball bearing that compresses in opposite directions along the axis at 180 °;
A first hemisphere transitioning in the direction of bodily fluid flow into a first linear path that slopes down at about 45 ° with respect to the axis perpendicular to the direction of fluid flow through the shut-off valve; A concave shaped like a
A second hemisphere transitioning in the direction of bodily fluid flow into a second linear path inclined downward at about 45 ° to the axis perpendicular to the direction of fluid flow through the shut-off valve A concave shaped like a
With
In the direction of fluid flow through the gravity shut-off valve, after each of the first and second hemispherically shaped recesses, the axial passage of the valve has a first and second ball bearing, respectively. The implantable bodily fluid drainage system of claim 1, wherein the system is narrowed to prevent it from passing through the axial passage. The collection container,
A main collection chamber;
A movable arm formed of three branches each having an end and an opposite end sharing a common intersection, wherein a first end of a first one of the movable arms is A movable arm, rotatably mounted on the inner surface of the collection chamber via a hinge, wherein a stopper head and a levitating member are disposed at the ends of the remaining two branches of the movable arm, respectively. A mechanical volume limiting mechanism;
Including
The levitation member rises simultaneously with the level of the fluid in the main collection chamber, and eventually the stopper head seats in the inlet port of the main collection chamber, closing the inlet port. The implantable bodily fluid drainage system of claim 1, wherein overfilling of the main collection chamber is prevented.   The implantable bodily fluid drainage system according to claim 9, wherein the movable arm is T-shaped or Y-shaped.   The collection container includes at least one auxiliary collection chamber in fluid communication with the main collection chamber to adjust a volumetric capacity of the fluid collected by the drainage system, wherein each of the at least one auxiliary collection chamber is associated with an associated collection chamber. The implantable bodily fluid drainage system according to claim 9, further comprising a shut-off valve. The mechanical volume limiting mechanism,
A central flotation member disposed inside the collection container having an inlet port defined on a top surface of the collection container, wherein the central flotation member is axially defined and has an opening defined therethrough. A central flotation member having:
A stopper head mounted on the upper surface of the central flotation member, the stopper head axially aligned with the inlet port of the collection container;
An axis attached to the bottom surface of the collection container and extending axially upward and toward the top surface of the collection chamber, wherein the axis passes through the opening defined in the central flotation member. 10. The implantable bodily fluid drainage system according to claim 9, comprising:   13. The implantable bodily fluid drainage system of claim 12, wherein a radial cross section of the central levitation member and a radial cross section of the shaft are complementary and non-circular. The collection container is configured as a two-part nested design of an upper housing tubular section and a lower housing tubular section, each of the upper and lower housing tubular sections having an open end and an opposing closed end; The open end of the lower housing tubular section is nested within the open end of the upper housing tubular section;
Complementary teeth that are in physical contact with each other are located on each mating surface of the upper and lower housing sections,
An O-ring is disposed between mating surfaces of the upper and lower housing sections;
The implantable bodily fluid drainage of claim 9, wherein the volume capacity of the collection container is adjustable by axially moving the lower housing tubular section relative to the upper housing tubular section. system. The volume restriction mechanism,
A flexible tube having a fixed end and an opposing free end, wherein the fixed end of the flexible tube is inserted into an inlet port defined on a top surface of the collection container. Meanwhile, the free end of the flexible tube extends into the collection container, and fluid passes axially through the flexible tube through a defined lumen and the levitation member is Disposed around the free end of a flexible tube, the levitation member rises in the axial direction simultaneously with the fluid level of the bodily fluid stored in the collection vessel, and at some point with the elevation of the levitation member, the levitation member rises. The sex tube bends to form a kink that tapers the flow of bodily fluid through it, and the bend in the flexible tube eventually blocks all flow of fluid therethrough, with an angle ≦ 90. 2. The implantable bodily fluid reservoir according to claim 1, wherein Trainer own system.

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