Portable fluid drainage and collection device

Abstract

A valve assembly for controlled drainage or delivery of fluid to or from a patient includes an outlet, an inlet, a diaphragm chamber, and a diaphragm dividing the diaphragm chamber into a first chamber cavity and a second chamber cavity. The diaphragm is deflectable toward a first wall of the diaphragm chamber, causing the first chamber cavity to contract and the second chamber cavity to expand, and conversely, deflectable toward a second wall of the diaphragm chamber, causing the second chamber cavity to contract and the first chamber cavity to expand. The plunger is translatable between a first operating state that establishes fluid communication between the outlet and the second chamber cavity and separately between the inlet and the first chamber cavity. The valve also has a second operating state that establishes fluid communication between the outlet and the first chamber cavity and separately between the inlet and the second chamber cavity.

Description

[Technical Field]

[0001] The present invention relates to a portable cerebrospinal fluid (CSF) drainage and collection system, and more particularly to a portable device for regulating the flow of CSF from a patient. [Background technology]

[0002] Normal pressure hydrocephalus (NPH) is a neurological disorder that afflicts an estimated 750,000 Americans. In NPH, the ventricles in the brain expand with unremoved cerebrospinal fluid (CSF), compressing surrounding brain tissue. This can lead to debilitating symptoms such as difficulty walking, urinary urgency and subsequent incontinence, and cognitive decline. The only known treatment for NPH is a surgical intervention called a shunt, in which a catheter is inserted through the skull into the ventricles and then threaded under the skin to another part of the body, typically the peritoneal cavity or venous system. The shunt facilitates the continuous drainage of excess cerebrospinal fluid, leading to symptom relief.

[0003] To determine whether a patient should receive a shunt (i.e., whether such treatment would be beneficial and relieve symptoms), multiple tests are performed. In many locations, patients are tested by draining CSF from the lumbar spine, which is intended to remove the CSF and simulate a shunt. This can be done either as a separate, single spinal tap test (outpatient) or as an inpatient, multi-day test using a short-term catheter.

[0004] Outpatient lumbar puncture testing involves only a very brief simulation of drainage under controlled conditions. Typically, 25–50 ml of CSF is removed. Inpatient testing requires immobilization of the patient and the nurse to care for the patient during drainage, consuming valuable medical resources. During an inpatient drainage test, hundreds of milliliters of fluid may be removed.

[0005] It would be desirable to provide a portable device that facilitates substantially continuous CSF drainage over a period of time, which would better simulate the performance and effectiveness of an implanted shunt, while allowing the patient to be free to ambulate and resume normal activities without being confined to a medical facility. Summary of the Invention

[0006] A valve assembly for controlled drainage or delivery of fluid to or from a patient is provided. The valve assembly includes an inlet, an outlet, a diaphragm chamber, and a diaphragm dividing the diaphragm chamber into a first chamber cavity and a second chamber cavity. The diaphragm is deflectable toward a first wall of the diaphragm chamber, causing the first chamber cavity to contract and the second chamber cavity to expand, and conversely, deflectable toward a second wall of the diaphragm chamber, causing the second chamber cavity to contract and the first chamber cavity to expand. The valve is operable between a first operating state that establishes fluid communication between the inlet and the second chamber cavity and, separately, between the outlet and the first chamber cavity. The valve also has a second operating state that establishes fluid communication between the inlet and the first chamber cavity and, separately, between the outlet and the second chamber cavity. The first chamber cavity and the second chamber cavity are fluidly isolated from each other in all operating conditions of the valve.

[0007] A valve assembly for controlled drainage or delivery of fluid to or from a patient is also provided. The valve assembly includes a diaphragm disposed within a diaphragm chamber, dividing the diaphragm chamber into a first chamber cavity and a second chamber cavity. The diaphragm is deflectable toward a first wall of the diaphragm chamber, contracting the first chamber cavity and expanding the second chamber cavity, and conversely, deflectable toward a second wall of the diaphragm chamber, contracting the second chamber cavity and expanding the first chamber cavity. The valve body includes a central chamber. An inlet passage fluidly connects the central chamber to an inlet of the valve body. An outlet passage fluidly connects the central chamber to an outlet of the valve body. The first chamber passage fluidly connects the central chamber to the first chamber cavity. The second chamber passage fluidly connects the central chamber to the second chamber cavity. A plug is disposed within the central chamber and is operable between a first operating state that establishes fluid communication between the inlet passage and the second chamber passage and, separately, between the outlet passage and the first chamber passage. The plug also has a second operating state that establishes fluid communication between the inlet passage and the first chamber passage and, separately, between the outlet passage and the second chamber passage. The first chamber cavity and the second chamber cavity are fluidly isolated from each other in all operating states of the plug.

[0008] A portable, ambulatory fluid drainage or delivery device comprising a pump assembly attachable to a patient. The pump assembly comprises: a pump operable to pump a fluid; a motor operable to operate the pump; a first port and a second port, each in fluid communication with the pump; and a controller configured to operate the motor to regulate operation of the pump to pump the fluid at a controlled rate. A reservoir cartridge is removably installable in the pump assembly and includes a reservoir disposed in communication with the second port upon installation of the reservoir cartridge in the pump assembly. The reservoir cartridge has a reservoir for holding a fluid. With the cartridge installed in the pump assembly, the device fits within a form-factor envelope having overall dimensions of about 500 mm x about 200 mm x about 100 mm or less. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a schematic diagram of a drainage system disclosed herein in use on a patient. [Figure 1A] 1 along line 1-1 of FIG. 1, and a plan view of the expandable pouch or bag of the reservoir in a first collapsed state. [Figure 1B] FIG. 1B is a cross-sectional view similar to FIG. 1A but showing the pouch / bag in a second expanded state. [Figure 2] FIG. 2 is a perspective view of a valve assembly of the drainage system of FIG. 1. [Figure 3] FIG. 3 is an exploded view of the valve assembly shown in FIG. 2. [Figure 4] 4 is a perspective view showing a cross section of the lower chamber body of the valve assembly of FIG. 2 taken along line 4-4 of FIG. 3. [Figure 5] FIG. 3 is a perspective view of a diaphragm of the valve assembly of FIG. 2. [Figure 6] 6 is a perspective view showing a cross section of the upper chamber body of the valve assembly of FIG. 2 taken along line 6-6 of FIG. 3. [Figure 7] 7 is a perspective view showing a cross section of the valve body of the valve assembly of FIG. 2 taken along line 7-7 of FIG. 3. [Figure 8] 8 is a perspective view showing a cross section of the valve plug of the valve assembly of FIG. 2 taken along line 8-8 of FIG. 2. [Figure 9] 9 is a perspective view showing a cross section of the valve assembly of FIG. 1 taken along line 9-9 of FIG. 2. [Figure 10] 10 is a cross-sectional view of the valve assembly of FIG. 2 taken along line 10-10 of FIG. 2, showing the valve plug in a first valve position. [Figure 11] FIG. 11 is a cross-sectional view similar to FIG. 10 but showing the valve plug in a second valve position. [Figure 12] FIG. 1 is an exploded view of a pump assembly and associated reservoir cartridge configured to be worn by a patient. [Figure 13A] FIG. 13 is a side view of the reservoir cartridge of FIG. 12. [Figure 13B] FIG. 13 is a perspective view of the pump assembly of FIG. 12. [Figure 14] 4 is an exploded view of a plunger assembly attached to the upper and lower chamber bodies of the pump assembly of FIG. 3. [Figure 15A] FIG. 15 is a perspective view of the adapter of the plunger assembly of FIG. 14. [Figure 15B] FIG. 15B is a cross-sectional view taken along line 15B-15B of FIG. 15A. [Figure 16] FIG. 15 is a perspective view of the plunger of the plunger assembly of FIG. 14. [Figure 17] FIG. 15 is a perspective view of the body of the plunger assembly of FIG. 14. [Figure 18A] FIG. 18A is a cross-sectional view taken along line 18A-18A of FIG. 17. [Figure 18B] FIG. 18B is a cross-sectional view taken along line 18B-18B of FIG. 17. [Figure 18C] FIG. 18C is a cross-sectional view taken along line 18C-18C of FIG. 17. [Figure 19] 19 is a cross-sectional view of the pump assembly of FIG. 14 taken along line 19-19 of FIG. 14, showing the plunger in a first actuated state. [Figure 20] FIG. 20 is a cross-sectional view similar to FIG. 19 but showing the plunger in a second actuated state. DETAILED DESCRIPTION OF THE INVENTION

[0010] As used herein, relative orientation terms such as "upper" and "lower" are used merely to distinguish one component or portion of a component from another component or portion of a component. Such terms are not intended to indicate preference or a particular orientation, and are not intended to limit embodiments of the present invention. For example, an "upper" element may be positionally located next to a "lower" element as disclosed herein, depending on the spatial orientation of the component that comprises them in real space. Alternatively, these "upper" and "lower" elements may even be inverted if the component that comprises them is inverted in reality.

[0011] 1 schematically illustrates a portable CSF drainage system 50 that may be carried by a patient 10. The drainage system 50 is shown as including a catheter 52 that is inserted into the lumbar canal to the intrathecal space that contains cerebrospinal fluid. However, it is contemplated that the drainage system 50 may be used in other applications where slow, controlled drainage of fluid from a patient is desired.

[0012] Drainage system 50 includes a catheter 52 that provides drainage access to a source of fluid to be drained, a drainage line 54 connected to catheter 52, a collection reservoir 80, a controller 90, and a valve assembly 100. In CSF drainage applications, catheter 52 is inserted into the lumbar canal of patient 10 to access the site requiring CSF drainage. One end of drainage line 54 is connected to catheter 52, and the opposite end of drainage line 54 is connected to inlet 182 ( FIG. 2 ) of valve assembly 100. It is contemplated that drainage line 54 and valve assembly 100 may utilize quick connections that allow an operator to quickly and easily attach / detach drainage line 54 to / from valve assembly 100.

[0013] The outlet 184 (FIG. 2) of the valve assembly 100 is connected to the reservoir 80 via a second line 56. It is contemplated that the second line 56 may include a quick connect at one or both ends to allow the reservoir 80 to be quickly and easily attached / detached to / from the valve assembly 100 and / or the reservoir 80. The reservoir 80 includes an internal cavity 80a that collects / stores CSF drained from the patient 10. The internal cavity 80a may be sized (and may be graduated) to hold a predetermined volume of CSF to limit and / or measure the amount of CSF drained from the patient 10.

[0014] A collapsible / expandable pouch or bag 82 can be disposed within the internal cavity 80a. In this embodiment, fluid collected within the reservoir 80 is accumulated within the expandable pouch / bag 82, which can expand to fill the internal cavity 80a, thus fixing the maximum volume of fluid that can be collected. The expandable pouch / bag 82 is typically supplied in a collapsed state (schematically shown in FIG. 1A) and is configured to expand to accommodate the collected fluid (e.g., CSF). An expandable member 84, e.g., a sponge, can be disposed within the expandable bag 82, and a vacuum can be applied to the bag 82 to compress the bag 82 against the expandable member 84 to achieve the collapsed state of the bag 82 as delivered, i.e., such that the bag 82 is under a vacuum in the collapsed state as delivered (FIG. 1A). The vacuum collapses the wall 82 a of the bag 82 against the expansion bias of the expandable member 84, compressing the expandable member 84. When connected to the valve assembly 100, the expansion bias of the expandable member 84 compresses the wall 82 a, expanding the bag 82, which can create a corresponding suction pressure on the drainage line 54 via the second line 56 and the valve assembly 100. This suction pressure can serve as a driving force to facilitate drainage of CSF from the patient 10 in a manner that is independent of hydrostatic pressure, i.e., Bernoulli equilibrium with the patient's head located above the reservoir 80. The expandable bag 82 will maintain a weak suction, which provides a driving force for CSF drainage, as long as the expandable member 84 within the expandable bag 82 continues to bias the bag 82 to further expand its volume. As CSF fills the internal cavity, the expandable member 84 expands by continuing to bias the bag 82 further, thereby maintaining suction pressure on the drain line 54. However, once the expandable bag 82 reaches its maximum volume (i.e., expands to fill the internal cavity 80a, as shown in FIG. 1B), no additional biasing force further expands the expandable bag 82, and the weak vacuum driving force for CSF drainage is removed. In this manner, once the reservoir 80 is filled to its maximum volume, no further CSF is drained.

[0015] 2, a motor 102 is attached to the valve assembly 100 to rotate a valve plug 202 of the valve assembly 100. The motor 102 is shown schematically in FIG. 2 and may be a stepper motor having a shaft that engages the plug 202 in the valve assembly 100. The motor 102 may be configured to rotate the plug 202 in one direction or to oscillate the plug 202, as described in more detail below.

[0016] The controller 90 is connected to the motor 102 to control its operation. The controller 90 can be a conventional microprocessor programmed to control the operation of the motor 102 according to a desired cycle. With reference to FIG. 1 , the controller 90 is shown attached to the reservoir 80, e.g., as part of a common assembly. Control lines 92 extend from the controller 90 to the motor 102 and control the operation of the motor 102. It is contemplated that the motor 102 can be controlled using wired or wireless connection methods. The controller 90 can include a power source (not shown), e.g., a battery, that enables the controller 90 to provide power to the motor 102. Alternatively, the motor 102 can include a power source (not shown), and the controller 90 can be programmed to determine when power from the power source is provided to the motor 102.

[0017] 2 and 3, valve assembly 100 is shown in detail. In the embodiment shown, valve assembly 100 is provided as a series of stacked elements, each formed (e.g., molded, machined, or 3D printed) with internal features to provide appropriate ducts and flow paths as described below when the respective elements are stacked. In this embodiment, the stacked elements include lower chamber body 112, upper chamber body 142, valve body 162, and cap 222. The remainder of the description will be provided in terms of a stacked configuration of the aforementioned elements. However, it is contemplated that valve assembly 100 can be constructed differently, for example, the entire assembly 100 can be fabricated as a single piece by additive manufacturing.

[0018] The lower chamber body 112 and the upper chamber body 142 together define a diaphragm chamber that houses the diaphragm 132, as will be further described. The diaphragm chamber is defined by a first dome-shaped recess 114 (FIG. 3) formed in the upper surface 112a of the lower chamber body 112 and a second dome-shaped recess 144 (FIG. 9) formed in the lower surface 142a of the upper chamber body 142. A plurality of holes 116 extend through the recess 114 and provide communication with a lower passageway 118 (FIG. 4) in the lower chamber body 112.

[0019] 4, the lower passage 118 is oval in shape and extends from the plurality of holes 116 (FIG. 3) to a lower passage outlet 122 (FIG. 3) at one corner of the lower chamber body 112. The lower passage outlet 122 (FIG. 3) extends from the lower passage 118 to the upper surface 112a of the lower chamber body 112. The lower passage outlet 122 (FIG. 3), the lower passage 118, and the plurality of holes 116 together define a lower conduit through the lower chamber body 112.

[0020] The holes 124 extend through opposite corners of the lower chamber body 112 for securing the lower chamber body 112 to the upper chamber body 142, as will be explained in more detail below.

[0021] The lower chamber body 112 is shown as a single, unitary structure with the lower chamber body 112 disposed therein. It is contemplated that the lower chamber body 112 may be manufactured using conventional additive manufacturing methods, also known as 3D printing. It is also contemplated that the lower chamber body 112 may be manufactured from two or more separate structures that are joined together to define the various features of the lower chamber body 112, as described in detail above. The separate structures may be joined together using conventional fasteners, adhesives, etc., so long as the various passageways within the lower chamber body 112 are fluid-tight when the separate structures are joined together.

[0022] The diaphragm 132 is disposed between the lower chamber body 112 and the upper chamber body 142. Referring to FIG. 5 , the diaphragm 132 has a central dome-shaped portion 136 that is contoured as described in detail below. A peripheral rim 134 extends around the dome-shaped portion 136. The diaphragm 132 is made of a flexible material selected to allow the dome-shaped portion 136 to flex, for example, it can be upwardly concave to conformally abut against the first dome-shaped recess 114 or downwardly concave to conformally abut against the second dome-shaped recess 144, as described in detail below.

[0023] Referring to FIG. 3, the upper chamber body 142 is attached to the lower chamber body 112 and captures the diaphragm 132 between the upper chamber body 142 and the lower chamber body 112 within a diaphragm chamber defined between the respective first (lower) dome-shaped recess 114 and second (upper) dome-shaped recess 144. Referring to FIG. 6, a plurality of holes 146 extend into the upper chamber body 142 to provide communication between the second recess 144 (FIG. 9) and an upper passage 148 of the upper chamber body 142. The upper passage 148 is oval in shape and extends from the plurality of holes 146 to an upper passage outlet 152 (FIG. 3) at one corner of the upper chamber body 142. The upper passage outlet 152 (FIG. 3) extends from the upper passage 148 through the top surface 142b of the upper chamber body 142. The upper passageway outlet 152 (FIG. 3), the upper passageway 148, and the plurality of holes 146 together define an upper passageway through the upper chamber body 142.

[0024] Threaded mounting holes 154 extend into the upper chamber body 142 adjacent opposite corners of the upper chamber body 142. The threaded mounting holes 154 are sized and positioned to align with the holes 124 in the lower chamber body 112. The holes 124 are sized to receive fasteners, such as screws, that are threaded into the threaded mounting holes 154 to secure the lower chamber body 112 to the upper chamber body 142. It is contemplated that a gasket or similar sealing member (not shown) may be disposed between the upper surface 112a of the lower chamber body 112 and the lower surface 142a of the upper chamber body 142 to promote or reinforce a fluid-tight seal between the respective chamber bodies 112, 142.

[0025] The upper chamber body 142 is shown as a single, unitary structure with the upper passageway 148 disposed therein. It is contemplated that the upper chamber body 142 may be manufactured using conventional additive manufacturing methods, also known as 3D printing. It is also contemplated that the upper chamber body 142 may be manufactured from two or more separate structures that are joined together to define the various features of the upper chamber body 142, as described in detail above. The separate structures may be joined together using conventional fasteners, adhesives, etc., so long as the various passageways within the upper chamber body 142 are fluid-tight when the separate structures are joined together.

[0026] The through-hole 156 extends through one corner of the upper chamber body 142 between the lower surface 142a and the upper surface 142b. The through-hole 156 is sized and positioned to align with the lower passageway outlet 122 (FIG. 3) in the lower chamber body 112, as described in detail below.

[0027] 9, a first recess 114 in the lower chamber body 112 and an opposing second recess 144 in the upper chamber body 142 define a diaphragm chamber of the valve assembly 100. The first recess 114 defines a first wall of the diaphragm chamber, and the second recess 144 defines a second wall of the diaphragm chamber. The diaphragm 132 is captured within the diaphragm chamber, dividing the diaphragm chamber into a first chamber cavity 158A and a second chamber cavity 158B. The first chamber cavity 158A is defined between the lower surface of the diaphragm 132 and the surface of the recess 114. The second chamber cavity 158B is defined between the upper surface of the diaphragm 132 and the surface of the recess 144. Because the recesses 114, 144 are fixed, movement of the diaphragm 132 within the internal cavity changes the volumes of the first chamber cavity 158A and the second chamber cavity 158B, but the overall volume of the diaphragm chamber remains constant.

[0028] 2 and 3, when assembled, the valve body 162 abuts (e.g., is attached to) the upper surface 142b of the upper chamber body 142. The valve body 162 includes a central opening 164 that extends through the valve body 162 from its upper surface 162a to its lower surface 162b. The central opening 164 is cylindrical and sized to allow the valve plug 202 to rotate freely therein, as described in detail below.

[0029] 7 , four chambers 172, 174, 176, 178 are equally spaced around the central opening 164 and each is in fluid communication with the central opening 164. The first chamber 172 is fluidly connected to a bore 182 a of an inlet 182 to the valve body 162, thereby defining an inlet passageway of the valve body 162. The second chamber 174, in the embodiment shown, is positioned diametrically opposite (i.e., offset 180 degrees from) the first chamber 172 and is fluidly connected to a bore 184 a of an outlet 184 from the valve body 162, thereby defining an outlet passageway of the valve body 162. The inlet 182 and outlet 184 are both shown as barbed fittings extending from respective side walls 162 c of the valve body 162. It is also contemplated that the inlet 182 and outlet 184 may be or comprise other conventional fittings that find particular use in making fluid-tight connections.

[0030] The third chamber 176, in the embodiment shown, is equicircumferentially distant from the first chamber 172 and the second chamber 174 relative to the central opening 164. A hole 186 extends through the lower surface 162b of the valve body 162 and is positioned to establish fluid communication with the third chamber 176. The hole 186 is positioned as described in detail below. The fourth chamber 178 is positioned diametrically opposite the third chamber 176 and equicircumferentially distant from the first chamber 172 and the second chamber 174. The hole 188 extends through the lower surface 162b of the valve body 162 and is positioned to establish fluid communication with the fourth chamber 178. The hole 188 is positioned as described in detail below.

[0031] Four blind, threaded mounting holes 192 extend from the top surface 162a (FIG. 3) into the valve body 162. The four threaded mounting holes 192 are equally spaced around the central opening 164 and are positioned as described in detail below.

[0032] The lower surface 162b of the valve body 162 is positioned in registration with the upper surface 142b of the upper chamber body 142. The bore 186 is positioned and sized to align with and establish fluid communication with the through-bore 156 (FIG. 3) in the upper chamber body 142. The bore 188 is positioned and sized to align with and establish fluid communication with the upper passage outlet 152.

[0033] 3, the plug 202 is sized to rotate within the central opening 164 of the valve body 162. The plug 202 includes a driver portion 202a and a plug body 206. The driver portion 202a includes a slot or groove 204 that is keyed to engage the drive shaft of the motor 102. It is also contemplated that the plug 202 can be integral with or part of the drive shaft for the motor 102.

[0034] 8, the plug body 206 includes a first passage 208 and a second passage 212. The passages 208, 212 are arcuate and each include a first end 208 a, 212 a and a second end 208 b, 212 b. The first passage 208 and the second passage 212 are positioned and configured such that as the plug 202 rotates within the valve body 162, the passages 208, 212 alternately establish specific lines of fluid communication between various ones of the chambers 172, 174, 176, 178, as described in detail below.

[0035] Referring again to FIG. 3 , when assembled, the cap 222 abuts (e.g., is attached to) the top surface 162 a of the valve body 162. The cap 222 includes a central opening 224 and four spaced-apart through-holes 226. When assembled, the cap 222 is configured to secure the plug 202 within the central opening 164 of the valve body 162. The central opening 224 is sized and positioned to accommodate the drive portion 202 a of the plug 202 so as to be accessible by the drive shaft of the motor 102. The holes 226 are sized and positioned to align with the threaded mounting holes 192 of the valve body 162 (see FIG. 9 ). Fasteners (not shown) are sized to extend through each hole 226 and thread into the threaded mounting holes 192 to secure the cap 222 to the valve body 162.

[0036] Valve assembly 100 will now be described with respect to its mode of operation. Referring to Figure 1, inlet 182 is attached to drain line 54, which is connected to catheter 52. Outlet 184 is attached to second line 56, which is connected to reservoir 80. As mentioned above, bag / pouch 82 is configured to have a slight vacuum such that a predetermined suction is applied to outlet 184 of valve assembly 100 upon connection with valve assembly 100.

[0037] 10 , operation of the valve assembly 100 will be described with the plug 202 starting in a first actuation state. In the first actuation state, the first passageway 208 in the plug 202 provides fluid communication between the second chamber 174 and the third chamber 176 of the valve body 162, and thus between the outlet 184 and the bore 186. The bore 186 extends through the valve body 162 and is in fluid communication with the through-hole 156 ( FIG. 3 ), the lower passageway outlet 122 ( FIG. 3 ), the lower passageway 118 ( FIG. 4 ), the plurality of holes 116 ( FIG. 3 ), and the first chamber cavity 158A. Thus, as can be seen, the third chamber 176, the bore 186, the through-hole 156, the lower passageway outlet 122, the lower passageway 118, and the plurality of holes 116 ( FIG. 3 ) define a first chamber passageway to the first chamber cavity 158A. It will be appreciated that when the valve plug 202 is in the first actuated state, the outlet 184 of the valve body 162 is ultimately positioned to be in fluid communication with the first chamber cavity 158A of the diaphragm chamber via the outlet passage (defined by the second chamber 174) and the first chamber passage, as defined in the preceding sentence.

[0038] Also in this first operating condition (FIG. 10), second passage 212 of rotor plug 202 provides fluid communication between first chamber 172 and fourth chamber 178, and thus between inlet 182 and bore 188. Bore 188 (FIG. 7) extends through valve body 162 and is in fluid communication with upper passage outlet 152 (FIG. 3), upper passage 148 (FIG. 6), plurality of bores 146 (FIG. 6), and second chamber cavity 158B. It can thus be seen that bore 188, upper passage outlet 152, upper passage 148, and plurality of bores 146 define a second chamber passage. Thus, when the valve plug 202 is in the first actuated state, the inlet 182 of the valve body is ultimately positioned to be in fluid communication with the second chamber cavity 158B of the diaphragm chamber via the inlet passage (defined by the first chamber 172) and the second chamber passage, as defined in the previous sentence.

[0039] 9 , when plug 202 is in the first actuated state as described above, a predetermined suction within reservoir 80 (e.g., resulting from the expansion bias of expandable member 84 within bag / pouch 82) is drawn against first chamber cavity 158A. This vacuum tends to draw diaphragm 132 toward first dome-shaped recess 114 until diaphragm 132 eventually seats against first dome-shaped recess 114. The resulting suction is configured to be sufficient to cause first chamber cavity 158A to contract as second chamber cavity 158B expands due to downward deflection of diaphragm 132, and the resulting suction pressure applied to upper passageway 148 via hole 146 will draw CSF from catheter 52. More simply, when the valve plug 202 is in the first actuated state, the applied suction pressure originating from or at the reservoir 80 will ultimately result in the drawing of CSF from the patient 10 into the second chamber cavity 158B. The drawing of fluid into the second chamber cavity 158B can continue under the influence of this pressure (suction) gradient until the second chamber cavity 158B is fully expanded, i.e., until the diaphragm (i.e., its dome-shaped portion) conformally seats against the first (lower) recess 114 in the lower chamber body 112. At that point, the second chamber cavity 158B cannot expand further and therefore can no longer accommodate any more fluid, and flow will cease.

[0040] It is also contemplated that upon connection of the drainage system 50 to the patient 10, the pressure of the CSF within the patient 10 can provide sufficient driving force to initiate drainage into the second chamber cavity 158B (in the first actuated state of the plug 202) without applying suction at or from the reservoir 80. In this situation, the head pressure of the CSF will be sufficient to drive flow and deflect the diaphragm 132 toward and ultimately into conformal contact with the lower recess 114.

[0041] After a predetermined time, the controller 90 can actuate the motor 102 to rotate the valve plug 202 to the second operating state shown in FIG. 11 (e.g., 90 degrees in the illustrated embodiment). In the second operating state, the first passageway 208 of the valve plug 202 establishes fluid communication between the fourth chamber 178 and the second chamber 174 (i.e., the outlet passageway), and thus between the hole 188 and the outlet 184. As described above, the hole 188, the upper passageway outlet 152 ( FIG. 3 ), the upper passageway 148 ( FIG. 6 ), and the plurality of holes 146 ( FIG. 6 ) define a second chamber passageway to the second chamber cavity 158B. At this point, fluid communication is established between the reservoir 80 and the second chamber cavity 158B of the diaphragm chamber via the outlet passageway and the second chamber passageway.

[0042] Also in this second operating state, the second passageway 212 of the valve plug 202 establishes fluid communication between the first chamber 172 (i.e., the inlet passageway) and the third chamber 176, and thus between the inlet 182 and the bore 186 of the valve body. As described above, the bore 186, the through-hole 156 (FIG. 3), the lower passageway outlet 122 (FIG. 3), the lower passageway 118 (FIG. 4), and the plurality of holes 116 (FIG. 3) define a first chamber passageway to the first chamber cavity 158A. At this point, fluid communication is established between the catheter 52 (connected to the inlet 182 via the drain line 54) and the first chamber cavity 158A of the diaphragm chamber via the inlet passageway and the first chamber passageway.

[0043] When plug 202 reaches the second actuated state, suction drawn from reservoir 80 and / or head pressure provided at the source of CSF within patient 10 deflects diaphragm 132 toward second dome-shaped recess 144 of upper chamber body 142, i.e., in the opposite direction compared to when plug 202 was in the first position. As diaphragm 132 moves, CSF from patient 10 is now drawn into first chamber cavity 158A, and CSF fluid present in second chamber cavity 158B (i.e., CSF that was present within plug 202 when it was in the first actuated state) is forced out outlet 184 and into reservoir 80, where it is collected in bag / pouch 82.

[0044] After a predetermined time, the controller 90 can again actuate the motor 102 to rotate the valve plug 202 (e.g., 90 degrees) back to the first actuation state shown in FIG. 10 . When the valve plug 202 returns to the first actuation state, the first chamber cavity 158A is again fluidly connected to the reservoir 80 (via the outlet 184), and the second chamber cavity 158B is fluidly connected to the catheter 52 (via the inlet 182). The head pressure of the CSF in the patient 10 and / or the suction pressure from the reservoir 80 deflects the diaphragm 132 toward the recess 114 in the lower chamber body 112. As the diaphragm 132 moves, CSF in the first chamber cavity 158A flows to the reservoir 80, while CSF from the catheter 52 is drawn into the second chamber cavity 158B. The diaphragm 132 continues to move until it conforms to the lower recess 114 as previously described.

[0045] The controller 90 can be programmed to continuously operate the motor 102, thereby oscillating the plug 202 between a first operating state ( FIG. 10 ) and a second operating state ( FIG. 11 ), for a predetermined period of time and / or according to a predetermined duty cycle, i.e., a fixed number of oscillations per hour or per day. This oscillation causes the second chamber cavity 158B and the first chamber cavity 158A to alternately fill with CSF from the patient 10 and alternately discharge collected CSF within the respective chambers 158A, 158B into the reservoir 80. In particular, as the second chamber cavity 158B fills with CSF from the patient 10, the first chamber cavity 158A discharges CSF into the reservoir 80. Similarly, as the second chamber cavity 158B discharges CSF into the reservoir 80, the first chamber cavity 158A fills with CSF from the patient 10.

[0046] The alternating filling of the second chamber cavity 158B and the first chamber cavity 158A with CSF is repeated until the desired amount of CSF is drained from the patient 10, or at a rate that achieves a desired drainage rate, e.g., mL per hour or mL per day. The timing of the oscillation of the plug 202 is selected to control the rate at which CSF is drained from the patient. For example, the first chamber cavity 158A and the second chamber cavity 158B can be sized to be approximately 1 mL (i.e., 1 cc), and the valve plug 202 can be actuated 10 times per hour for 10 hours, resulting in a total of 100 mL of CSF being drained into the reservoir 80 at a rate of 10 mL per hour. If a higher or lower speed is needed, the motor 102 is actuated faster or slower, or the recesses 114, 144 are sized larger or smaller.

[0047] The plug 202 can oscillate back and forth between a first actuation state (FIG. 10) and a second actuation state (FIG. 11), i.e., it can oscillate by rotating clockwise to one position and then counterclockwise to the other position. In this mode of operation, the first passageway 208 always remains in fluid communication with the outlet 184 but alternates between the second chamber cavity 158B and the first chamber cavity 158A. Thus, the first passageway 208 is used only to alternately drain CSF from the second chamber cavity 158B and the first chamber cavity 158A. Similarly, the second passageway 212 always remains in fluid communication with the inlet 182 but alternates between the second chamber cavity 158B and the first chamber cavity 158A. Thus, the second passageway 212 is used solely to alternately supply CSF from the patient 10 to the second chamber cavity 158B and the first chamber cavity 158A.

[0048] Alternatively, the plug 202 can be configured to be rotated only in one direction, e.g., clockwise, to achieve the disclosed vibrations. In this mode of operation, in a first operating state (FIG. 10), the first passage 208 initially connects the outlet 184 to the first chamber cavity 158A. Then, by rotating the plug 202 90 degrees clockwise, the first passage 208 connects the inlet 182 to the first chamber 158A (see FIG. 11, where the first passage 208 is positioned where the second passage 212 is positioned). When the plug 202 is rotated another 90 degrees clockwise, the first passage 208 connects the inlet 182 to the second chamber 158B. When the plug 202 is rotated again 90 degrees clockwise, the first passage 208 connects the outlet 184 to the second chamber 158B (FIG. 11). Rotating the plug 202 another 90 degrees clockwise returns the plug 202 to the first valve position (FIG. 10). The second passageway 212 is similarly indexed through successive 90-degree rotations of the plug 202. In other words, as the valve plug 202 is rotated in a clockwise direction, the respective passageways 208, 212 alternately connect the inlet 182 and outlet 184 to the first and second chamber cavities 158A, 158B in the same manner as described above for oscillating the plug 202 between the first (FIG. 10) and second (FIG. 11) operating states, i.e., by successive 90-degree rotations in opposite directions.

[0049] As will be appreciated, the disclosed valve assembly 100 provides a mechanism for achieving CSF drainage at a rate that can be guaranteed not to exceed a ratio of X / Y, where X is the maximum volume (e.g., in mL) of one of the upper chamber 158B and the lower chamber 158A (assuming they have the same maximum volume), and Y is the time interval (e.g., in hours) between successive actuations of the valve plug 202 via the motor. Because the diaphragm 132 can only deflect to a maximum extent (i.e., to conform to either the lower recess 114 or the upper recess 144) in either the first or second actuation state of the valve plug 202, the maximum volume of each chamber 158A, 158B is fixed. Therefore, by adjusting the oscillation speed of the valve plug, the maximum rate of CSF drainage can be precisely controlled, thereby ensuring that CSF is not drained faster than desired. Furthermore, if the system loses power (e.g., if the on-board battery runs down), fluid drainage will eventually stop once the chamber cavities 158A, 158B in communication with the catheter 52 fill up. This may have the effect of increasing the patient's CSF pressure, but avoids the potentially dangerous situation of continuing to drain CSF unrestrained in the event of a power outage.

[0050] Furthermore, applying a predetermined, fixed suction pressure from the reservoir 80 (e.g., using the expandable member 84, as described above) ensures a substantially constant and controllable driving force for drainage. By selecting a sponge (for example) with a predetermined degree of elasticity, its expansion bias can be selected to achieve a desired small pressure gradient to ensure CSF drainage in a manner independent of gravity or the relative geometry / position of the patient or the relative geometry / position between the catheter and the reservoir. It is also contemplated that the internal cavity 80a of the reservoir 80 can have a fixed volume under vacuum. A vacuum can be applied to the internal cavity 80a at the time of manufacture, and the reservoir 80 can be sealed until the user connects the reservoir 80 to the valve assembly 100. This can be an important feature for ambulatory drainage, since unlike a clinical setting where gravity drainage can be efficiently used, the patient's position may change uncontrollably throughout the day or duration of treatment while the patient is unrestrained. Additionally, by selecting a desired maximum volume for the reservoir bag / pouch 82, the maximum amount of fluid drainage can be fixed. That is, once the bag / pouch 82 is filled to its maximum capacity, further drainage automatically stops because the bag / pouch 82 will no longer expand to accommodate any more fluid. This eliminates both the vacuum driving force resulting from such expansion, if vacuum is relied upon for drainage, and the overhead pressure driving force that occurs within the patient when downstream pressure increases to match that overhead pressure (i.e., further flow into the reservoir is obstructed).

[0051] And finally, the valve system disclosed herein also acts as a check valve to prevent backflow from reservoir 80 into patient 10. This may be a desirable feature if reservoir 80 encounters external forces that tend to compress its volume (e.g., which may occur unpredictably because this is a portable device). It may also be desirable if reservoir 80 becomes full so as not to exert back pressure that would tend to push CSF back into patient 10. Fixed maximum volume chamber cavities 158A, 158B coupled with plug 202 ensure that there is no direct communication line between reservoir 80 and catheter 52, so that backflow between them is not possible.

[0052] Although the above embodiments have been described with respect to draining CSF from a patient 10, it should be understood that these embodiments may also be utilized for controlled drainage of any other organ or space of or within a patient where metered, controlled, ambulatory drainage is desired.

[0053] The above description relates to the use of the disclosed device to drain CSF or other fluids from a reservoir of such fluid within a patient, for example, to treat conditions resulting from excessive accumulation of such fluids. However, it should be understood that the disclosed device can also be operated in the reverse manner, such that rather than draining fluid from a reservoir of such fluid within a patient, the device can be used to deliver a therapeutic agent from a reservoir to a desired location within the patient via a valve and catheter. To achieve such operation, the fluid flow would be reversed compared to that described, for example, by reversing the direction of the pressure gradient between reservoir 80 and the body cavity to which the fluid is to be delivered. In one such mode of operation, the reservoir can receive a supply of therapeutic agent at a high enough pressure to drive the fluid through the device and into the patient.

[0054] In this embodiment, reservoir 80 is a pressurized supply reservoir that holds a therapeutic agent. This pressurized supply reservoir is connected to outlet 184 of valve assembly 100, and catheter 52 is connected to inlet 182. It is contemplated that bag 82 of reservoir 80 can be filled with a therapeutic agent, and the interior cavity 80a around bag 82 can be filled with a pressurized fluid (e.g., using a gas or volatile vapor as the pressurizing agent). The pressurized fluid is provided under a pressure sufficient to exceed the head pressure of the CSF (or other bodily fluid or space) within the patient, such that the therapeutic agent flows from reservoir 80 to the patient upon actuation of valve assembly 100. Controller 90 can be programmed to operate valve assembly 100 at a desired frequency and for a predetermined period of time to deliver the therapeutic agent to the patient at a desired rate in a manner similar to that described above with respect to drainage.

[0055] 12, an exemplary embodiment is shown in which the disclosed valve assembly 100 is integrated with a pump assembly 300, which, when operated in the manner described above, forms a wearable unit that can be worn by an ambulatory patient to receive drainage of CSF (or other fluid) or, optionally, delivery of a therapeutic agent. As shown schematically in FIG. 12, the controller 90 and valve assembly 100 are integrated with the pump assembly 300, which, as shown, can take the form of a substantially flattened form factor device and can be worn as an adhesive patch. The reservoir 80 can be provided within a removable reservoir cartridge 250 that can be reversibly mated and secured to the pump assembly 300 to place the reservoir 80 in fluid communication with the valve assembly 100 and facilitate drainage / delivery of fluid from / to the reservoir 80.

[0056] Specifically, with reference to FIG. 13B, pump assembly 300 defines a receptacle 306 that receives reservoir cartridge 250. It is contemplated that the power source that provides energy to the motor that drives the valve assembly may be a battery 230 integrated with reservoir cartridge 250. In this manner, when reservoir cartridge 250 is mated to pump assembly 300 within receptacle 306, battery 230 is placed in electrical communication with the motor via electrical contacts 252 positioned on cartridge 250 that engage contact points 302 ( FIG. 13B ) positioned on pump assembly 300. In this manner, each time a cartridge is replaced (e.g., because its reservoir 80 has filled with drained fluid or the therapeutic fluid being delivered to the patient has been depleted), a new battery is supplied to the motor to ensure reliable operation.

[0057] Reservoir cartridge 250 may also include a radio frequency identification device (RFID) 254 or other indicator, e.g., a bar code, that identifies the volume of reservoir 80. When installed in pump assembly 300, RFID 254 or other indicator can be read by a detector 304 ( FIG. 13B ) integrated with pump assembly 300 and in communication with on-board controller 90, so that controller 90 knows the maximum volume of CSF (or other fluid) that can be held by reservoir 80. Controller 90 can then be programmed to operate to drain only as much CSF as reservoir 80 can hold and then, optionally, sound an alarm (e.g., via an audible or visually perceptible signal) when the maximum volume of CSF drained is reached. Alternatively, when operated to deliver a therapeutic agent, RFID 254 or other indicator can indicate the amount of agent to deliver, so that the controller can adjust the rate and amount of delivery, as well as sound an alarm when the therapeutic agent is depleted.

[0058] The receptacle 306 can include contact points 302 positioned to engage electrical contacts 252 of the reservoir cartridge 250 when the reservoir cartridge 250 is engaged with the pump assembly 300. The detector 304 can be positioned within the receptacle 306 in a location that allows the detector 304 to read an RFID 254 or other indicator on the reservoir cartridge 250. It is contemplated that the pump assembly 300 and / or the reservoir cartridge 250 can include retention features, such as an interference fit, a snap fit, a spring-loaded tab, or the like, that can be used to secure the reservoir cartridge 250 to the receptacle 306. In the embodiment shown, the pump assembly 300 includes a spring-loaded tab 308 at its base that cooperates with a boss 258 that extends from the top end of the cartridge 250 and is configured to be received within a cooperating recess 309 ( FIG. 13B ) in the pump assembly 300. To fit cartridge 250, its boss 258 first fits into a recess 309 (FIG. 13B) or similar device that secures reservoir cartridge 250 within receptacle 306. The base of cartridge 250 is then pressed against pump assembly 300, and tab 308 interferes with a flange or recess 259 (FIG. 13A) in cartridge 250, holding it in place. To release cartridge 250, tab 308 is deflected against its bias, removing said interference so that cartridge 250 can be removed.

[0059] The inlet 182 of the valve assembly 100 is located within a receptacle 306 of the pump assembly 300 and may be positioned and dimensioned to engage contact ports 256 (e.g., complementary fittings) on the reservoir cartridge 250 when the reservoir cartridge 250 is installed within the receptacle 306. A seal 256a, e.g., an O-ring, may be provided on the port 256 to provide a fluid-tight connection between the port 256 and the inlet 182. The outlet 184 of the valve assembly 100 exits the side of the pump assembly 300 and may be connected to the catheter 52 via the drain line 54. In this regard, CSF from the patient 10 (FIG. 1) may pass through the valve assembly 100 during operation and fill the reservoir 80 of the reservoir cartridge 250, similar to that previously described. In particular, inlet 182 and outlet 184 are so named in reference to the use of the disclosed system as a drainage device, with fluid entering from the patient via inlet 182 and eluting via outlet 184 into reservoir 80. However, as previously explained, the system can be operated in a reverse (therapeutic agent delivery) mode, such that inlet 182 actually elutes fluid and outlet 184 draws fluid in. In this sense, inlet 182 and outlet 184 can be thought of more generally as a first port and a second port, each of which can be an inlet or an outlet depending on the mode of operation.

[0060] It is further contemplated that an adhesive panel 312 may be attached to the rear wall of the pump assembly 300 to secure the pump assembly 300 to the patient 10 (FIG. 1). The adhesive panel 312 may be coated with a skin-compatible adhesive for ease of application and wear by the patient 10 (FIG. 1). It is also contemplated that suture anchors or belts may be used to secure the pump assembly 300 to the patient 10 (FIG. 1).

[0061] In a preferred embodiment, the overall size of both pump assembly 300 and reservoir cartridge 250 should fit within a form factor envelope that facilitates ambulatory wear by an outpatient. For example, the combined device can fit within a form factor envelope having overall dimensions of about 500 mm x about 200 mm x about 100 mm or less, preferably about 300 mm x about 100 mm x about 50 mm or less, more preferably about 250 mm x about 75 mm x about 30 mm or less, and even more preferably about 100 mm x about 70 mm x about 20 mm or less. Additionally, to enable patient 10 (FIG. 1) to comfortably wear pump assembly 300 and reservoir cartridge 250 for extended periods of time, the combined device (pump assembly 300 and cartridge 250 with a fully filled reservoir) is preferably constructed from materials such that the total combined weight is less than 16 ounces, preferably less than 12 ounces, and more preferably less than 8 ounces. In long-term use, after a patient 10 (FIG. 1) has used one reservoir cartridge 250 (e.g., the reservoir is either filled with drained fluid or depleted of therapeutic agent, depending on the mode of operation), the reservoir cartridge 250 can be removed and a new reservoir cartridge 250 can be placed into the receptacle 306 for continued treatment.

[0062] In the disclosed embodiment, the valve assembly 100 includes a valve that facilitates pumping by arranging opposing diaphragm chamber cavities in alternating serial communication between a collection site for a fluid (e.g., excess CSF in a patient) and a target for that fluid (e.g., reservoir 80), with an external pressure gradient providing the driving force. In this embodiment, the diaphragm-mediated valve assembly 100 (assisted by an external pressure gradient) acts as a pump. The valve assembly 100 can be configured with other types of valves suitable for facilitating pumping when actuated by an external pressure gradient as disclosed. Additionally, the valve assembly 100 can comprise or be configured with a conventional pump that does not rely on an external pressure gradient to induce flow, but rather mechanically provides the motive force for flow. For example, conventional pumps such as peristaltic pumps, positive displacement pumps, piston pumps, centrifugal pumps, etc. can be used.

[0063] According to an alternative embodiment shown in Figures 14-20, the valve plug 202, valve body 162, and cap 222 described above are replaced with a plunger assembly 400 comprising a plunger 410 and a passage body 420.

[0064] 16, the plunger 410 may be an elongated cylindrical rod having a first through hole 412 and a second through hole 414, respectively, extending radially through the plunger 410. The first through hole 412 and the second through hole 414 are positioned and sized as described in detail below.

[0065] 14 and 17, the passage body 420 can have an elongated rectangular shape having a first end 420a and a second end 420b. A central opening 422 extends through the passage body 420 from the first end 420a to the second end 420b along a longitudinal axis A of the passage body 420. The central opening 422 is sized to allow the plunger 410 to move axially therethrough.

[0066] An outlet channel 442 and an inlet channel 444 also extend axially into the passage body 420 from the first end 420a of the passage body 420, while a first port channel 446 and a second port channel 448 extend axially into the body from the second end 420b of the passage body 420. As shown, the outlet channel 442, the inlet channel 444, the first port channel 446, and the second port channel 448 are distributed around the longitudinal axis A of the body so as to extend parallel to the longitudinal axis A. In the illustrated embodiment, the outlet channel 442, the inlet channel 444, the first port channel 446, and the second port channel 448 are located adjacent to respective corners of the rectangular passage body 420.

[0067] 18B, first and second upper connecting passages 452a, 452b fluidly connect the central opening 422 to the outlet channel 442. Third and fourth upper connecting passages 452c, 452d fluidly connect the central opening 422 to the inlet channel 444. In the illustrated embodiment, the upper connecting passages 452a, 452b, 452c, 452d are circular passages each having a vertical portion (see FIG. 18A) and a horizontal portion (see FIG. 18B). It is contemplated that the upper connecting passages 452a, 452b, 452c, 452d may have other cross-sectional shapes, such as rectangular cross-sectional shapes, or may be straight passages.

[0068] 18C, first and fourth lower connecting passages 454a, 454d fluidly connect the central opening 422 to the first port channel 446. Second and third lower connecting passages 454b, 454c fluidly connect the central opening 422 to the second port channel 448. In the illustrated embodiment, the lower connecting passages 454a, 454b, 454c, 454d are circular passages each having a vertical portion (see FIG. 18A) and a horizontal portion (see FIG. 18C). It is contemplated that the lower connecting passages 454a, 454b, 454c, 454d may have other cross-sectional shapes, such as a rectangular cross-sectional shape, or may be straight passages.

[0069] 14-15B, an adapter 405 is positioned between the passage body 420 and the upper chamber body 142. The adapter 405 includes a first through-hole 406 and a second through-hole 407 extending from the upper surface 405a to the lower surface 405b. When the adapter 405 is positioned between the passage body 420 and the upper chamber body 142, the first through-hole 406 is positioned and dimensioned to fluidly connect the second port channel 448 (opening at the second end 420b of the passage body 420) to the through-hole 156 in the upper chamber body 142. Meanwhile, the second through-hole 407 is positioned and dimensioned to fluidly connect the first port channel 446 (also opening at the second end 420b of the passage body 420) to the upper passage outlet 152 of the upper chamber body 142. In the embodiment shown (see FIG. 15B), the second through-hole 407 of the adapter 405 takes the form of an S-shaped passageway such that the opening in the upper surface 405a is offset from the opening in the lower surface 405b.

[0070] 14 , an actuator 460, e.g., a solenoid or motor, is attached to the first end 420a of the passage body 420. The actuator 460 is configured to engage an end of the plunger 410 to move the plunger 410, as described in detail below. The actuator 460 may include a rod (not shown) that applies a force to the end of the plunger 410, for example, pushing the plunger 410 in one direction against the action of a counter spring 462, thereby achieving reciprocation of the plunger. Alternatively, the actuator 460 may be connected (e.g., threadedly coupled) to the end of the plunger 410 so as to actively reciprocate the plunger 410 in two opposite axial directions.

[0071] 19 and 20, the plunger 410 is positioned within the central opening 422 and is configured to move between a first actuation state (FIG. 19) and a second actuation state (FIG. 20). When in the first actuation state, the first through-hole 412 in the plunger fluidly connects the first upper connecting passage 452a to the first lower connecting passage 454a, and the second through-hole 414 in the plunger fluidly connects the third upper connecting passage 452c to the third lower connecting passage 454c. When in the second actuation state, the first through-hole 412 in the plunger fluidly connects the second upper connecting passage 452b to the second lower connecting passage 454b, and the second through-hole 414 in the plunger fluidly connects the fourth upper connecting passage 452d to the fourth lower connecting passage 454d. An actuator 460 drives the plunger 410 between a first position (FIG. 19) and a second position (FIG. 20).

[0072] In one embodiment, a spring 462 (FIGS. 19 and 20) is positioned between the end of the plunger 410 and the end of the central opening 422. The spring 462 is configured to bias the plunger 410 toward the second actuated state (FIG. 20). The spring 462 can assist the actuator 460 in returning the plunger 410 to the second actuated state, or the spring 462 can provide the only force pushing the plunger 410 toward the second actuated state.

[0073] The plunger assembly 400 will now be described with respect to its mode of operation. Referring to FIG. 14, the opening of the inlet channel 444 at the first end 420a of the passage body is attachable to the drain line 54 (FIG. 1), which is further connected to the catheter 52. The opening of the outlet channel 442 at the first end 420a is attached to the second line 56 (FIG. 1), which is further connected to the reservoir 80. As mentioned above, the bag / pouch 82 is configured to have a slight vacuum. In this manner, when connected to the plunger assembly 400, a predetermined suction is applied to the outlet channel 442 of the plunger assembly 400.

[0074] The passage body 420, the adapter 405, and the upper chamber body 142 are dimensioned such that, when assembled together, the first port channel 446 of the passage body 420, the second through-hole 407 of the adapter 405, and the upper passage outlet 152 of the upper chamber body 142 are in fluid communication with one another. As described in detail above, the upper passage outlet 152 is in fluid communication with the second chamber cavity 158B (FIG. 9). Thus, fluid entering the first port channel 446 is in communication with the second chamber cavity 158B. Similarly, the second port channel 448 of the passage body 420, the first through-hole 406 of the adapter 405, and the through-hole 156 of the upper chamber body 142 are in fluid communication with one another. As described in detail above, the through-hole 156 is in fluid communication with the first chamber cavity 158A (FIG. 9). Thus, fluid entering the second port channel 448 communicates with the first chamber cavity 158A.

[0075] 19 (with the actuator removed for clarity), operation of the plunger assembly 400 will be described with the plunger 410 starting in a first actuated state. In the first actuated state, the second through-hole 414 of the plunger 410 provides fluid communication between the third upper connecting passage 452c and the third lower connecting passage 454c, and thus between the inlet channel 444 and the second port channel aaa 448. As discussed above, the second port 448 is in fluid communication with the first chamber cavity 158A ( FIG. 9 ) via the first through-hole 406 and the through-hole 156. It can be seen that when the plunger 410 is in the first actuated state, the catheter 52 (connected to the inlet channel 444) ultimately comes into fluid communication with the first chamber cavity 158A.

[0076] In the first actuation state, the first through-hole 412 of the plunger 410 provides fluid communication between the first upper connecting passage 452a and the first lower connecting passage 454a of the passage body 420, and thus between the outlet channel 442 and the first port channel 446. As discussed above, the first port channel 446 is in fluid communication with the second chamber cavity 158B (FIG. 9) via the second through-hole 407 and the upper passage outlet 152. It can be seen that when the plunger 410 is in the first actuation state, the reservoir 80 is ultimately in fluid communication with the second chamber cavity 158B.

[0077] As explained in detail above, connecting the reservoir 80 (which is under negative pressure) to the second chamber cavity 158B causes the second chamber cavity 158B to contract while the first chamber cavity 158A expands. The expansion of the first chamber cavity 158A draws CSF from the patient 10 into the first chamber cavity 158A.

[0078] After a predetermined time, the controller 90 can actuate the actuator 460 to move, or translate, the plunger 410 to a second actuation state shown in Figure 20. In the second actuation state, the second through-hole 414 of the plunger 410 establishes fluid communication between the fourth upper connecting passage 452d and the fourth lower connecting passage 454d, and thus between the inlet channel 444 and the first port channel 446. At this point, fluid communication is established between the catheter 52 (connected to the inlet channel 444 via the drain line 54) and the second chamber cavity 158B (connected to the first port 446).

[0079] Also, in the second actuated state, the first through-hole 412 of the plunger 410 establishes fluid communication between the second upper connecting chamber 452b and the second lower connecting chamber 454b, and thus between the outlet channel 442 and the second port channel 448. At this point, fluid communication is established between the reservoir 80 (connected to the outlet 442 via the second line 56) and the first chamber cavity 158A (connected to the second port 448).

[0080] In this state, the second chamber cavity 158B expands while the first chamber cavity 158A contracts. The expansion of the second chamber cavity 158B draws CSF out of the catheter 52, while the contraction of the first chamber cavity 158A forces the CSF therein into the reservoir 80. Repeated movement of the plunger 410 between the first and second actuated states alternately connects the reservoir 80 and the catheter 52 to the first and second chamber cavities 158A and 158B. This alternating connection is configured to controllably transport CSF from the patient 10 to the reservoir 80.

[0081] While the present invention has been described in connection with selected embodiments, it should be understood that the scope of the invention should not be limited thereby, but instead encompasses all modifications and variations thereof that are within the spirit and scope of the appended claims.

Claims

1. 1. A valve assembly for controlled drainage or delivery of fluid to a patient, comprising: The exit and The entrance and A diaphragm chamber; a diaphragm dividing the diaphragm chamber into a first chamber cavity and a second chamber cavity, the diaphragm being deflectable toward a first wall of the diaphragm chamber, causing the first chamber cavity to contract and the second chamber cavity to expand, and conversely, being deflectable toward a second wall of the diaphragm chamber, causing the second chamber cavity to contract and the first chamber cavity to expand; A plunger, a first operating state that establishes fluid communication between the outlet and the second chamber cavity, and separately between the inlet and the first chamber cavity; a second operating state that establishes fluid communication between the outlet and the first chamber cavity, and separately between the inlet and the second chamber cavity; a plunger translatable between Equipped with The valve assembly, wherein the first chamber cavity and the second chamber cavity are fluidly isolated from each other under all actuation conditions of the plunger.

2. 2. The valve assembly of claim 1, wherein the plunger is configured to be continuously translated between the first actuation state and the second actuation state, wherein in the first actuation state fluid can be drawn from the patient or from a pressurized supply reservoir up to a maximum volume of the first chamber cavity, and wherein in the second actuation state fluid can be drawn from the patient or from the pressurized supply reservoir up to a maximum volume of the second chamber cavity.

3. 3. The valve assembly of claim 2, wherein the maximum volume of the first chamber cavity is equal to the maximum volume of the second chamber cavity, the maximum volume of the first chamber cavity being achieved by biasing the diaphragm against the second wall of the diaphragm chamber, and the maximum volume of the second chamber cavity being achieved by biasing the diaphragm against the first wall of the diaphragm chamber.

4. 2. The valve assembly of claim 1, wherein movement of the diaphragm toward the second wall when the plunger is in the first actuated state causes fluid accumulated in the second chamber cavity to exit through the outlet while fluid is drawn into the first chamber cavity through the inlet, and wherein movement of the diaphragm toward the first wall when the plunger is in the second actuated state causes fluid in the first chamber cavity to exit through the outlet while fluid is drawn into the second chamber cavity through the inlet.

5. an actuator for translating the plunger; a controller for controlling the operation of the actuator; Further provided with The valve assembly of claim 1 , wherein the actuator is configured to engage a first end of the plunger and move the plunger from the first actuated state to the second actuated state.

6. 6. The valve assembly of claim 5, further comprising a spring attached to an opposite second end of the plunger, biasing the plunger toward the first actuated condition.

7. 6. The valve assembly of claim 5, wherein the actuator is operatively coupled to the first end of the plunger and configured to move the plunger to sequentially achieve the first actuation state and the second actuation state.

8. 1. A fluid drainage system for controlled drainage of fluid from a patient, comprising: The valve assembly of claim 1; a drain line fluidly connected between the patient and the inlet for draining fluid from the patient; a collection reservoir fluidly connected to the outlet for collecting the fluid drained from the patient; Equipped with and wherein movement of the diaphragm toward the second wall when the plunger is in the first actuated state causes fluid accumulated in the second chamber cavity to exit through the outlet and accumulate in the reservoir, while fluid from the patient is drawn into the first chamber cavity through the inlet and through the drain line, and wherein movement of the diaphragm toward the first wall when the plunger is in the second actuated state causes fluid in the first chamber cavity to exit through the outlet and accumulate in the reservoir, while fluid from the patient is drawn into the second chamber cavity through the inlet and through the drain line.

9. an actuator for translating the plunger; a controller for controlling the operation of the actuator; Further provided with The fluid drainage system of claim 8 , wherein the actuator is configured to engage a first end of the plunger and move the plunger from the first actuated state to the second actuated state.

10. 10. The fluid drainage system of claim 9, wherein the valve assembly, the actuator, and the controller are all integrated together in a small, portable pump assembly that can be worn or carried by an ambulatory patient.

11. 9. The fluid drainage system of claim 8, further comprising a vacuum drawn against the outlet that tends to bias the diaphragm toward the second wall in the first actuated state of the plunger and that tends to bias the diaphragm toward the first wall in the second actuated state of the plunger.

12. The fluid drainage system of claim 11 , wherein the reservoir comprises an expandable bag in fluid communication with the outlet, expansion of the bag providing the vacuum drawn against the outlet.

13. 13. The fluid drainage system of claim 12, further comprising an expandable member disposed within the expandable bag of the collection reservoir, the expandable member having an expansion bias that tends to compress an interior wall of the bag, thereby expanding a volume of the bag.

14. 1. A valve assembly for controlled drainage or delivery of fluid to a patient, comprising: a diaphragm disposed within the diaphragm chamber, dividing the diaphragm chamber into a first chamber cavity and a second chamber cavity, the diaphragm being deflectable toward a first wall of the diaphragm chamber to contract the first chamber cavity and expand the second chamber cavity, and conversely, the diaphragm being deflectable toward a second wall of the diaphragm chamber to contract the second chamber cavity and expand the first chamber cavity; a body having a central chamber, first and second upper connecting passages fluidly connecting the central chamber to an outlet of the body, third and fourth upper connecting passages fluidly connecting the central chamber to an inlet of the body, a first lower connecting passage fluidly connecting the central chamber to a first port of the body, second and third lower connecting passages fluidly connecting the central chamber to a second port of the body, and a fourth lower connecting passage fluidly connecting the central chamber to the second port, wherein the first port is fluidly connected to a first chamber cavity and the second port is fluidly connected to the second chamber cavity; Located within the central chamber, a first operating state establishing fluid communication between the first upper connecting passage and the first lower connecting passage, and separately between the third upper connecting passage and the third lower connecting passage; a second operating state establishing fluid communication between the second upper connecting passage and the second lower connecting passage, and separately between the fourth upper connecting passage and the fourth lower connecting passage; a plunger translatable between Equipped with The valve assembly, wherein the first chamber cavity and the second chamber cavity are fluidly isolated from each other under all actuation conditions of the plunger.

15. a first diaphragm body having the first wall of the diaphragm chamber formed as a recess on its upper surface; a second diaphragm body having the second wall of the diaphragm chamber formed as a recess on its underside; Further provided with 15. The valve assembly of claim 14, wherein the upper surface of the first diaphragm body is positioned in alignment with the lower surface of the second diaphragm body such that the first wall and the second wall define and enclose the diaphragm chamber.

16. 15. The valve assembly of claim 14, wherein the plunger is configured to be sequentially actuated between the first actuation state and the second actuation state, wherein in the first actuation state fluid can be withdrawn from the patient up to a maximum volume of the first chamber cavity and in the second actuation state fluid can be withdrawn from the patient up to a maximum volume of the second chamber cavity.

17. 17. The valve assembly of claim 16, wherein the maximum volume of the first chamber cavity is equal to the maximum volume of the second chamber cavity, the maximum volume of the first chamber cavity being achieved by biasing the diaphragm against the second wall of the diaphragm chamber, and the maximum volume of the second chamber cavity being achieved by biasing the diaphragm against the first wall of the diaphragm chamber.

18. the plunger includes a first through hole and a second through hole; In the first operating state, the first through-hole fluidly connects the first upper connecting passage to the first lower connecting passage, and separately, the second through-hole fluidly connects the third upper connecting passage to the third lower connecting passage; 15. The valve assembly of claim 14, wherein in the second operating state, the first through-hole fluidly connects the second upper connecting passage to the second lower connecting passage, and separately, the second through-hole fluidly connects the fourth upper connecting passage to the fourth lower connecting passage.

19. 1. A fluid delivery system for controlled delivery of a fluid to a patient, comprising: The valve assembly of claim 1; a supply line fluidly connected between the patient and the outlet for delivering fluid to the patient; a pressurized supply reservoir fluidly connected to the inlet for supplying the fluid to the patient; Equipped with and when the plunger is in the second actuated state, movement of the diaphragm toward the second wall causes fluid accumulated in the second chamber cavity to exit through the outlet and flow to the patient, while fluid in the pressurized supply reservoir is forced through the inlet and through the supply line into the first chamber cavity.

20. 20. The fluid delivery system of claim 19, further comprising a pressurized fluid forced against the outlet that tends to bias the diaphragm toward the first wall in the first actuated state of the plunger and tends to bias the diaphragm toward the second wall in the second actuated state of the plunger.

Images