System and method for a valve

Abstract

A system includes a flow regulation system. This flow regulation system helps ensure a selected pressure within the inlet volume. The flow regulator may be included in a flow splitter assembly (10).

Description

[0001] Cross-references to related applications

[0002] This application includes subject matter similar to PCT applications (Agent No. 5074X-000061-WO), (Agent No. 5074X-000062-WO), and (Agent No. 5074X-000063-WO). The entire disclosure of each of the foregoing applications is incorporated herein by reference. Technical Field

[0003] This disclosure relates to valves, and more particularly to valve assemblies having inlet and outlet conduits. Background Technology

[0004] This section provides background information in connection with this disclosure, which is not necessarily prior art.

[0005] Subjects, such as human patients, may have a treatable condition. For example, hydrocephalus generally includes the excessive production of cerebrospinal fluid in the ventricles of the brain and / or the abnormal absorption or outflow of cerebrospinal fluid from the brain. Therefore, this condition may lead to an inappropriate or undesirable increase in the volume of cerebrospinal fluid (CSF) in the ventricles and an increase in intracranial pressure.

[0006] In various situations, a shunt can be implanted into the subject. The shunt may include an inflow duct located within the ventricles of the brain and an outflow duct located distal to the brain. Thus, excess cerebrospinal fluid (CSF) can flow from the ventricles to a selected location within the subject. The flow of CSF from the ventricles through the inflow and outflow ducts allows for the presence of an appropriate or selected volume of CSF within the brain to achieve a selected intracranial pressure. However, it is necessary to maintain the selected pressure within the ventricles. Summary of the Invention

[0007] This section provides a general overview of this disclosure and is not a full disclosure of the complete scope or all features of this disclosure.

[0008] The catheter can be positioned in a selected site in a subject, such as the ventricles of a human subject. The catheter may include a passage, such as a foramen, through a selected portion of the catheter. The catheter may also include an end-tube or channel to allow selected materials, such as fluids, to flow through it. In various embodiments, the catheter may allow the flow of cerebrospinal fluid (CSF). The catheter may be implanted as part of a shunt system to shunt or drain CSF from a first location to a second location.

[0009] The shunt assembly may include a catheter positioned within the ventricles of the brain and a catheter positioned at a location remote from the brain's ventricles. A flow regulation system may be positioned between the ventricles and the remote location. This flow regulation system may include a valve assembly positioned in line with the catheter. This valve assembly can be used to regulate or select the pressure to be maintained within the ventricles.

[0010] In various embodiments, the valve assembly may include an opening or rupture pressure. This rupture pressure needs to be reached and / or exceeded to open the valve and allow fluid flow through it. The valve assembly may include portions that allow for changes in the inlet pressure before the valve opens, as discussed further herein. Therefore, the valve assembly can be used to maintain a selected volume and / or pressure within the ventricles.

[0011] The valve assembly may include a selected opening or rupture pressure. This opening pressure can be used to select a selected pressure to be maintained within the ventricles of the subject. Maintaining a selected pressure within the subject's ventricles allows for the maintenance of a selected volume or pressure of fluid at the inlet location of the shunt assembly. For example, the ventricle can be selected to maintain a selected volume or pressure, but allow fluid to drain from the ventricle if excessive or a selected threshold pressure has been reached.

[0012] Further areas of applicability will become apparent from the description provided herein. The descriptions and specific examples in this overview are intended for illustrative purposes only and are not intended to limit the scope of this disclosure. Attached Figure Description

[0013] The accompanying drawings described herein are for illustrative purposes only, representing selected embodiments and not all possible specific implementations, and are not intended to limit the scope of this disclosure.

[0014] Figure 1 This is a schematic diagram of the shunt and system environment located within the subject's body according to various implementation schemes. Figure 2

[0015] Figure 2 It is a top plan view of the valve assembly according to various implementation schemes;

[0016] Figure 3 It is along Figure 2 The cross-sectional view of line 3-3;

[0017] Figure 4 yes Figure 3 An exploded view of the valve assembly;

[0018] Figure 5A This is a first perspective exploded view of the box assembly according to various implementation schemes;

[0019] Figure 5B yes Figure 5A The second perspective exploded view of the box component;

[0020] Figure 6 It is based on various implementation plans, such as Figure 5A The image shows a detailed view of the interior of the housing of the box assembly.

[0021] Figure 7It is along Figure 5A A cross-sectional view of the assembled box assembly taken from line 7-7;

[0022] Figure 8A This is a first perspective exploded view of the box assembly according to various implementation schemes;

[0023] Figure 8B yes Figure 8A The second perspective exploded view of the box component;

[0024] Figure 9 Is it like this? Figure 8A The image shows a detailed view of the interior of the housing of the box assembly.

[0025] Figure 10 It is along Figure 8A A cross-sectional view of the assembled box assembly taken from line 10-10;

[0026] Figure 11A This is a first perspective exploded view of the box assembly according to various implementation schemes;

[0027] Figure 11B yes Figure 11A The second perspective view of the decomposed box component;

[0028] Figure 12 It is based on various implementation plans, such as Figure 11A The image shows a detailed view of the interior of the housing of the box assembly.

[0029] Figure 13 It is along Figure 11A A cross-sectional view of the assembled box assembly taken from line 13-13;

[0030] Figure 14A This is a first perspective exploded view of the box assembly according to various implementation schemes;

[0031] Figure 14B yes Figure 14A The second perspective view of the decomposed box component;

[0032] Figure 15 It is based on various implementation plans, such as Figure 14A The image shows a detailed view of the interior of the housing of the box assembly.

[0033] Figure 16 It is along Figure 14A A cross-sectional view of the assembled box assembly, taken from line 16-16;

[0034] Figure 17 This is a schematic diagram of a spring having a selected free length and a second selected free length;

[0035] Figure 18A This is a first perspective exploded view of the box assembly according to various implementation schemes;

[0036] Figure 18B This is a bottom perspective view of the disassembled box components.

[0037] Figure 19 It is along Figure 18A A cross-sectional view of the assembled box assembly, taken from line 19-19;

[0038] Figure 20A It is a top perspective view of the disassembled box components according to various implementation schemes;

[0039] Figure 20B It is a bottom perspective view of the box components broken down according to various implementation schemes;

[0040] Figure 21 It is along Figure 20A A cross-sectional view of the assembled box assembly taken from line 21-21;

[0041] Figure 22 This is a top perspective view of the valve assembly according to various implementation schemes;

[0042] Figure 23 It is cut along line 23-23. Figure 22 A cross-sectional view of the valve assembly;

[0043] Figure 24 yes Figure 22 An exploded view of the valve assembly;

[0044] Figure 25 yes Figure 24 Exploded perspective view of the valve assembly's box assembly;

[0045] Figure 26 It is along Figure 25 A cross-sectional view of the assembled box assembly taken from line 26-26;

[0046] Figure 27 It is a perspective view of the valve assembly according to various implementation schemes;

[0047] Figure 28 yes Figure 27 An exploded view of the valve and housing assembly; and

[0048] Figure 29 It is a section taken along line 29-29. Figure 27 A cross-sectional view of the assembled valve assembly;

[0049] In several views of all the accompanying drawings, the corresponding reference numerals indicate the corresponding components. Detailed Implementation

[0050] The example implementation will now be described in more complete form with reference to the accompanying drawings.

[0051] First refer to Figure 1 The diagram illustrates a shunt system 10. This shunt system may include an inlet or first conduit 14 and an outlet or second conduit 18. Conduits 14, 18 include components or wall structures that include or define outer surfaces 22, 26. Conduits 14, 18 may include a selected length or be formed along a long or longitudinal axis. In various embodiments, conduit 14 may be provided as an inlet or inlet conduit or portion for use as a shunt component 10 in a hydrocephalus shunt. The hydrocephalus shunt may be configured (e.g., formed, assembled, and / or implanted) to shunt cerebrospinal fluid (CSF) from a location near a first or inlet portion 30 of conduit 14 in the ventricle 34 of the brain 38 of the subject 40 to a second or distal end 42 located away from or away from the inlet end or portion 30. The second or outlet end 38 may be located in a selected portion of the subject 40, such as the peritoneum 48.

[0052] Fluids such as cerebrospinal fluid (CSF) can flow along catheter 22 from ventricle 34 generally toward outlet end 38 in the direction of arrow 50. As commonly understood by those skilled in the art, inlet catheter 22 may be positioned (i.e., implanted) in ventricle 34 to allow drainage of fluid away from ventricle 34. Inlet catheter 22 may be part of shunt system 10, which includes selected flow control systems, such as valve assembly 60 according to various embodiments, as discussed further herein.

[0053] The valve assembly 60 can be implanted in a suitable location within the subject 40. In various embodiments, the valve assembly 60 can be implanted substantially subcutaneously near the ear 64 of the subject 40, or any other suitable location. It should be understood that the inlet catheter 22 can be connected to the valve assembly 60. Therefore, both the inlet catheter 22 and the valve assembly 60 can be implanted in the subject 40.

[0054] This disclosure includes exemplary applications for draining CSF from a subject. However, it should be understood that the valve assembly 60 may be used or implemented for alternative purposes, depending on various embodiments and / or portions thereof. For example, to drain selected fluid from any suitable part of a subject. Furthermore, the subject may be alive or inanimate. For example, the valve assembly may be used to control the flow rate or pressure from a first groove to a second groove or drainage tube.

[0055] The valve assembly 60 can also be connected to the outlet catheter 26. The outlet catheter 26 can extend from the valve assembly 60 to a selected location, such as the abdominal cavity 48 of the subject 40. The inlet catheter 22, valve assembly 60, and outlet catheter 26 can generally be understood as a shunt system 10, such as a hydrocephalus shunt system. The shunt system 10 can be implanted integrally into the subject 40.

[0056] Fluid can flow through inlet conduit 22 in the direction of arrow 54 to valve assembly 60. Fluid can then flow generally in the direction of arrow 64 through valve assembly 60 and through outlet conduit 26. Fluid can then drain or pass through outlet conduit 26 into the abdominal cavity 48 of subject 40 or any other suitable location. It should be understood that outlet conduit 26 can be positioned appropriately within subject 40 to allow CSF drainage from ventricle 34 to suitable locations, such as locations with high blood flow. Therefore, as... Figure 1 As illustrated, the inlet catheter 22, valve assembly 60, and outlet catheter 26 can be implanted or positioned in the subject 40 as a CSF shunt system.

[0057] Continue to refer to Figure 1 And further reference Figure 2 , Figure 3 and Figure 4 The valve assembly 60 is illustrated and will be described in more detail. The valve assembly 60 may include an inlet end or portion 80 and an outlet end or portion 84. Each of the ends 80, 84 may include a connection portion for connection to a corresponding conduit 22, 26. For example, an inlet barb 88 may engage an inlet conduit 22 and an outlet barb 92 may engage an outlet conduit 26. However, it should be understood that other suitable connection mechanisms may be provided to connect the valve assembly 60 to the corresponding conduits 22, 26. Furthermore, the first end or inlet end 80 may be connected to or formed with a base member or base portion 94. The base portion 94 may provide a base for the valve assembly 60 and its various portions, as discussed further herein. The base 94 may be formed as a single piece with the inlet 80 and / or may be formed from separate parts held together using a selected bonding system including acoustic welding, adhesives, etc. Furthermore, the base 94 may be positioned on a sheet or cover 98. In various embodiments, the valve assembly 60 may be positioned within a subject 40, as discussed above. The sheet 98 can help provide a barrier and / or a robust or rigid base for the valve assembly 60 between a selected portion of the subject 40 and the valve assembly 60. Furthermore, the sheet 98 can help maintain the valve assembly 60 in a selected position relative to the subject 40.

[0058] A base 94 having an inlet 80 may define an inlet passage 100. The inlet passage 100 may extend to a first reservoir or guide region 104. The guide region 104 may guide fluid flow generally in the direction of arrow 54 into the reservoir volume 108. The reservoir volume 108 can be reached through a passage 112 between the base 94 and the dome or cover 116. The dome or cover 116 may be formed of a selected material (such as silicon and / or selected polymers) and is fixed to the base 94 and / or the sheet 98. The connection between the dome 116 and the base 94 and / or the sheet 98 can be in any suitable manner, such as using adhesives, acoustic welding, etc. Forming a dome 116 separate from the base 94 and / or the sheet 98 may facilitate the manufacture or assembly of the valve assembly 60. However, those skilled in the art will understand that, according to various embodiments, the base 93, the sheet 98, and / or the dome 116 may be formed as a single component. Furthermore, as Figure 4 As shown in the illustration, dome 116 can be formed as a single component, and / or can be formed from multiple components fixed together.

[0059] The dome 116 may at least partially define the reservoir volume 108 relative to the base 94. Furthermore, the dome 116 may cover or enclose the cartridge assembly 120. The cartridge assembly 120 may include an inlet 124 accessible via a channel 128 formed between the dome 116 and the cartridge assembly 120. The cartridge assembly 120 may include portions that assist in forming selected resistance or opening pressure, as discussed further herein. Thus, the cartridge assembly 120 includes an inlet 124 and a cartridge outlet 132.

[0060] Box outlet 132 may be connected to or connected to flow limiting assembly 138. Flow limiting assembly 138 may also be referred to as restrictive or selective chamber assembly 138, which includes chamber base 142 and chamber housing or cover 146. Flow limiting assembly 138 may include, as included in The chamber in the valve, A valve is a device that minimizes the excessive drainage of fluids such as cerebrospinal fluid (CSF). Therefore, when the valve portion and cartridge assembly 120 are open, the chamber 142 with housing 146 helps maintain or limit a selected outflow rate from the valve assembly 60. For example, a flow limiting assembly 138 can limit the outflow from the valve assembly 60 to a selected amount, which depends at least in part on a positive pressure at the inlet side of the flow limiting assembly 138 and a negative pressure at the outlet side of the flow limiting assembly 138. Generally, the flow limiting assembly 138 will maintain a selected pressure at which the valve assembly is open, as discussed herein. Therefore, chamber 142 may include or define a restrictive volume region 150 accessible from cartridge outlet 132 through inlet 154. Flow limiting assembly 138 may also include an outlet end 84. The valve is sold by Medtronic, Inc., a company with a business presence in Minnesota, USA.

[0061] In various embodiments, the current limiter assembly 138 may be removably connected to the housing assembly 120. For example, the chamber base 142 may include an engagement edge or recess 158. The engagement recess 158 may be engaged by a wing or finger 162 of the housing assembly 120. Thus, according to various embodiments, the current limiter assembly 138 may be removably connected to the housing assembly 120.

[0062] The valve assembly 60 may also include a cartridge assembly 120 held in a selected base or region 170 of the base 94. The cartridge holding region 170 may include an outer wall or ridge 174 that facilitates holding or securing the cartridge assembly 120 relative to the reservoir volume 108. Thus, the valve assembly 60 may be provided as a device for implantation into the subject 40, such as... Figure 2 The valve assembly unit or component is shown in the figure.

[0063] Therefore, in short, the shunt assembly 10 may include an inlet catheter 22 positioned within the ventricle 34. The inlet catheter 22 will allow cerebrospinal fluid (CSF) to flow through it to the inlet end 80 of the valve assembly 60. The CSF can flow through the inlet 80 and into the reservoir 108. Within the reservoir 108, the valve assembly 60 is substantially open to the ventricle 34. Therefore, the pressure within the reservoir 108 can be substantially equal to the pressure within the ventricle 34.

[0064] Therefore, another channel 128 is also open to the reservoir 108. As discussed herein, the cartridge assembly 120, including the valve mechanism, can open at a selected pressure, which may be formed within the reservoir 108 due to the inflow of CSF or other selected fluids from the ventricle 34 through the inlet conduit 22. At the selected pressure, the valve mechanism within the cartridge assembly 120 can open and allow CSF to flow out through the cartridge assembly 120 to the cartridge assembly outlet 132. The flow restrictor assembly 138 may help maintain a selected outflow rate to the outlet conduit 26. Thus, the reservoir 108 can be maintained at a selected volume and / or pressure, ensuring that the valve assembly 60 substantially does not discharge CSF. In various embodiments, the reservoir may be maintained substantially filled during use. However, under various conditions, the reservoir 108 may be left unfilled and the filling percentage may be based on the amount of CSF produced and / or the drainage rate. Additionally, a valve assembly may be included to maintain a selected pressure within the ventricle 34, such as water from about 0 cm to about 30 cm, including water from about 0 cm to about 20 cm, and also including water not exceeding about 20 cm. Those skilled in the art will understand that the cm of water is measured at standard temperature and pressure. Wherein, according to the National Institute of Standards and Technology (NIST), the cm of water is defined in a column having a cross-sectional area.

[0065] Continue to refer to Figures 2 to 4 And refer to other sources. Figure 5A , Figure 5B , Figure 6 and Figure 7 The diagram illustrates a box assembly 120 according to various embodiments in more detail. Box assembly 120 generally includes a box base or housing 190. The box housing 190 may include an outer wall 194 defining an internal volume 196. Furthermore, the wall 194 may define or form an internal thread 200. Box assembly 120 may also include a removable or selectively positionable cap 204, which includes an external thread 208 that can threadedly engage the internal thread 200 of the box base 190. Thus, in various embodiments, the cap 200 can threadedly engage the base 190 to assemble box assembly 120. It should be understood that other adjustable or selectively positionable connections, such as ratchet and pawl, or other suitable connection mechanisms, may be provided. However, threaded engagement allows for selective positioning of the cap 204, as discussed herein. It should be understood that, for example, when the cap 204 is positioned in a selected location relative to the base 190, the cap 204 can also be secured to the base 190 in any suitable manner (such as using adhesives, sonic welding, etc.). Therefore, the box assembly 120 can be assembled in any suitable manner. Generally, the cap 204 defines or forms the entrance 124 of the box assembly 120.

[0066] The housing body 190 may enclose at least a portion of the valve mechanism 220 of the valve assembly 60. The valve mechanism 220 may include a ball or movable sealing portion 224 that may engage a sealing portion or area 228 of the cap 204. Figure 7As illustrated, cap 204 may define a cone or truncated cone including a tapered wall 232. The tapered wall or conical portion 232 may have a first diameter or dimension 236 larger than the diameter dimension 238 of ball 224. The tapered wall 232 may include a second dimension 242 at the sealed position, which is smaller than the dimension 238 of ball 224. Thus, when ball 224 is pressed into sealing region 228, ball 224 can seal seal 228 by engaging tapered wall 232. Ball 224 may be held or biased generally within sealing region 228 in the direction of arrow 246 by biasing member 250. Biasing member may be an adjusting member, as discussed herein, and may include a spring, which may be referred to as adjusting or biasing spring 250. Spring 250 may generally include a selected spring force, which may be selected based on the dimensions of cartridge assembly 120, to ensure that a selected force (e.g., biasing force) is applied to ball 224 to enter sealing region 228. As discussed further herein, a sealing spring 250 may be positioned between an adjusting member 254 and a ball 224, which may also be referred to as a rotating body, and may operate as a pressure selection member. The rotating body 254 may facilitate selection of the opening (i.e., activation) pressure of the housing assembly 120 of the valve assembly 60, as discussed further herein. The opening or activation pressure may be a threshold pressure at which the valve system (such as a valve mechanism according to various embodiments) will open and allow flow through the valve inlet.

[0067] The valve mechanism 220 also includes a return spring 258, which helps to maintain the rotating body 254 within the housing 190. The return spring 258 can engage the cap 204 and the rotating body 254 in a return spring slot or recess 262. Therefore, when the cap 204 is engaged with the housing 190, the return spring 258 can selectively hold the rotating body 254 within the housing 190.

[0068] Additionally, the housing assembly 120 may include a sealing member 266, which may be a gasket or a ring. The sealing member or gasket 266 may engage between the cap 204 and the housing 190. For example, as Figure 7 As illustrated, when the cap 204 engages (e.g., via a corresponding thread) to the housing 190, the sealing member 266 can be sealingly engaged to the housing 190. Therefore, the internal volume 196 within the housing 190 can be sealed or substantially closed relative to the external environment through the inlet 124 and the outlet 132.

[0069] In short, for reference Figure 7At least a portion of the housing assembly 120 can function as a valve mechanism for the valve assembly 60. The inlet 124 is located on the inflow side within the valve assembly 60 or allows fluid to flow in generally in the direction of arrow 280. The ball 224 can also generally move in the direction of arrow 280 when the pressure is sufficient to overcome the force of the spring 250. The CSF can then flow through the inlet 124 and into the volume 196. The CSF can then flow generally in the direction of arrow 284 through the outlet 132. Therefore, as the ball 224 moves away from the valve seal 228, the CSF can enter the inlet 124 of the housing assembly 120 and pass through the valve seal portion 228. The CSF can flow through the housing volume 196 and exit the housing outlet 132 generally in the direction of arrow 284.

[0070] The box assembly 120 can be configured or assembled to include a selected opening pressure caused by the positioning of the spring 250 and the spring force or opening force generated by the spring 250 placed on the ball 224 in the seal 228. The force applied to the ball 224 by the spring 250 can be selected based on the position of the adjusting base or surface 290 of the adjusting member 254 relative to the sealing area 228. Figure 7 As illustrated, when ball 224 is in a selected position, sealing region 228 can seal relative to ball 224. For example, ball 224 may have a sealing contact edge or surface 294 that engages sealing region 228. The position of sealing edge 294 of ball 224 can be selectively positioned at different heights relative to spring engagement surface 290 of rotating body 254 to change or alter the force applied to ball 224 by spring 250.

[0071] Continue to refer to Figure 5A And specifically refer to Figures 5B to 7 The box assembly includes a selection area 300. The selection area 300 may include two or more surfaces (also referred to as steps) having varying heights within the box volume 196. A first height may be defined by a base or bottom subsurface surface 304. A second height may be defined by a first step or raised area 308. A third height may be defined by a second step 312. Similarly, a fourth and fifth height may be defined relative to each other by corresponding steps 316 and 318. Figure 6 As illustrated, a first step 308 may have a height 322 relative to the base or bottom layer 304. A second step 312 may have a second height 326 relative to the base 304. Each of these steps or positions 304-318 may include different or varying heights, and the two heights 322, 326 are illustrated merely for clarity of the present discussion. In various embodiments, for example, the step height may vary from about 0.001 mm to about 0.5 mm, including about 0.01 mm to about 0.3 mm, and also including about 0.1 mm to about 0.2 mm.

[0072] The rotating body 254 may include an adjustment area 330. The bottom area 330 may include a foot or step engagement portion or surface 334. The step engagement portion 334 may extend a distance 338 from the bottom surface 342 of the rotating body 254. The distance 338 may allow the foot or step engagement portion 334 to selectively and individually engage one or more of the areas 304-318 of the height selection area 300.

[0073] Furthermore, the rotating body 254 may include a central hole or channel 346. The hole 346 may include a selected shape, such as a polygonal shape, which may include a substantially pentagonal shape, including multiple sides, such as side 350. The housing 190 may define or include a central hook or protrusion 354. The protrusion 354 may include multiple sides and generally has a selected cross-section or external shape, such as a polygonal shape that may include a pentagonal shape. For example, the protrusion 354 may include multiple sides 356. Thus, the protrusion 354 may engage in the channel 346 of the rotating body. Because the protrusion 356 and the channel 346 are complementary in shape, the rotating body 254 may be rotated to a selected position relative to the protrusion 356 and then rotatably held relative to the protrusion due to the non-circular shape of the protrusion 354 engaging the recess or through hole 346. Thus, the rotating body 254 may be rotatably positioned and held on the protrusion 356.

[0074] When the rotating body 254 is rotatably positioned on the protrusion 356, the foot or positioning portion 334 engages one of the selected steps or surface portions of the selection area 300. For example, in a first position, the foot 334 may engage or contact the surface of the base 304. In a second position, the foot 334 may engage the first step 308 and be positioned at a height 322 above the base 304.

[0075] When the foot 334 engages the step 308, the foot 334 is at a distance 322 above the base 304. Therefore, when the sealing member 224 is positioned within the seal or the support 228, the distance 322 causes the rotating body 254 to compress the spring 250. Due to the height 322, the compression of the spring 250 will exert an additional force on the ball 224 to enter the sealing area 228. Therefore, the biasing force will increase or change relative to when the rotating body 254 is positioned in a rotational position such that the foot 334 engages the base 304. Similarly, when the rotating body 254 rotates onto one of the other steps of the selection area 300, the force or initial bias applied to the spring 250 and correspondingly to the ball 224 will change.

[0076] The position of the rotating body 254 on a selected step in the selected area 300 is chosen to determine the initial force or opening force applied to move the ball 224 away from the sealing area 228. Therefore, by positioning the rotating body 254 such that the foot 334 engages with a selected step or section 304-318, the opening force required to move the ball 224 generally in the direction of arrow 280 is altered, such that the greater the height above the base 304, the greater the force required to move the ball 224 from the sealing position to the seal 228. Each step can be selected to achieve a selected opening pressure, such as water pressure from about 0 cm to about 40 cm, including water pressure from about 0 cm to about 20 cm, and including pressures greater than about 20 cm.

[0077] Furthermore, the cap 224, which is threaded into the housing 190, may also have a position that changes relative to the rotating body 254. For example, the cap 204 may be loosened or moved generally in the direction of arrow 246 to reduce opening pressure, and / or moved generally in the direction of arrow 280 to increase opening pressure. The pitch of the threads 200, 208 may be selected to allow for smaller adjustments than those caused by moving the rotating body 254 to different steps in the steps of the adjustment zone 300. Thus, fine-tuning or adjustment between the steps of the adjustment zone 300 can be achieved by moving the cap (e.g., tightening or loosening the cap 204) relative to the rotating body 254 in alternative directions 246, 280.

[0078] Therefore, the housing assembly 120 can be set to a selected opening pressure, such as during manufacturing or at any appropriate time. For example, the valve mechanism 220 can be assembled into the housing 190 at a selected opening pressure. The same valve mechanism can be set to different opening pressures by positioning the rotating body 254 at different positions on the adjustment zone 300. Thus, the valve mechanism 220 can be used to achieve multiple fixed or selected valve opening pressures using the same valve mechanism components.

[0079] Alternatively, the user may select a pressure from a number of possible opening pressures at the time of implantation or during implantation. The cassette assembly 120 may subsequently include the selected opening pressure without requiring adjustment and / or the ability to adjust after implantation without removing the cassette assembly 120.

[0080] In various embodiments, adjusting spring 280 can be fixed to rotating body 254 in a selected manner (such as by welding, adhesive, etc.). Similarly, return spring 258 can also be fixed to rotating body 254 in a similar manner. However, it should be understood that during the use and operation of box assembly 120, the compressive force of cap 204 on rotating body 254 can selectively hold the respective springs 250, 258 in place.

[0081] Additionally, depending on the construction of the adjustment assembly 300, the rotating body 254 may include a plurality of stepped engagement portions 334. Furthermore, as a supplement to and / or alternative to the return spring 258, the rotating body 254 may be bonded to the housing 190 in a selected manner. For example, the rotating body 254 may be adhered to the adjustment portion 300 using a biocompatible adhesive to hold the rotating body 254 in a selected position relative to the housing 190. The return spring 258 may be provided, or it may be omitted, allowing the rotating body 254 to be held in the housing 190 without the return spring 258.

[0082] Furthermore, the rotating body 254 may include any selected channel shape that is complementary to the protrusion 354 in the housing 190. For example, the protrusion 354 may be hexagonal, octagonal, or any other suitable shape. This shape can determine the number of selected adjustments in which the rotating body 254 can be positioned relative to the housing 190, and may also depend on the number of variations provided in the adjustment area 300. Thus, the illustration of the pentagonal shape of the protrusion 354 is merely exemplary, and a hexagonal shape, for example, may be provided in the adjustment area 300 along with six optional steps.

[0083] Continue to refer to Figures 1 to 4 And refer to other sources. Figure 8A , Figure 8B , Figure 9 and Figure 10 The diagram illustrates a housing assembly 420. Housing assembly 420 may be included together with valve assembly 60, as discussed above. Housing assembly 420 may include portions similar to housing assembly 120, as discussed above. Therefore, portions substantially identical to housing assembly 120 will not be discussed in more detail here, but can be discussed with reference to housing assembly 120. Housing assembly 420 may include portions substantially identical to housing assembly 120, such as outlet 132, engaging or connecting wings or protrusions 162. Therefore, housing assembly 420 may be connected to or within valve assembly 60. However, housing assembly 420 may include a valve mechanism 430, which may be positioned within housing 434 to selectively adjust or select the opening pressure in a manner further discussed herein.

[0084] The housing 434 may include an outer wall 438 defining an internal thread 442, similar to the outer wall discussed above. Therefore, the cap 446 may also include an external thread 450 that can thread-engage the internal thread 442. The cap 446 may also include or define an inlet 454 similar to the inlet 124 discussed above. Therefore, the housing assembly 420 may be positioned within the valve assembly 60 in a manner similar to that of the housing assembly 120, as discussed above.

[0085] Furthermore, cap 446 may define a sealing region 460 that seals against or engages a sealing member, such as ball 464. Ball 464 may be biased into sealing region 460 by biasing member 468, which may be a pressure regulating spring similar to spring 250 discussed above. Valve mechanism 430 may also include adjusting member 472, which may also be referred to as rotator 472. Adjusting member 472 may selectively provide an adjustable or selected position of adjusting spring 468 within housing 434. As further discussed herein, rotator 472 may be positioned within housing 434 to assist in selecting the opening pressure of housing assembly 420. Additionally, return spring 476 may be provided to assist in holding rotator 472 within housing 434. However, as discussed above, rotator 472 may also be secured within housing 434, such as by adhesive or similar mechanisms. Furthermore, valve assembly 430 may include sealing member 480, such as gasket or O-ring.

[0086] As discussed above, the sealing member 464 may be a sphere or ball and may be positioned within the sealing area 460 of the cap 446. An adjusting spring 468 may bias the ball 464 onto the sealing area 460. An upper adjusting surface 490 of the rotating body 472 that contacts or engages the spring 468 may be moved within the housing 434 to a selected height, such that the adjusting surface 490 is positioned at a selected height from the sealing position 494 of the ball 464 within the seal 460.

[0087] The rotating body 472 may have a bottom or second surface 500 opposite to or opposite to the spring engagement surface 490. The rotating body 472 may also include one or more protrusions, such as a first external protrusion 504 and a second internal protrusion 508. The two protrusions 504, 508 may protrude from the bottom surface 500 by selected distances 512, 516. In various embodiments, the distances 510, 516 may be the same. However, in various embodiments, the distances 512, 516 may be different.

[0088] The protrusions 504 and 508 engage with the selection mechanism or region 520 within the housing 434. Selection region 520 may be similar to selection region 300 as discussed above. However, selection region 520 will be discussed further herein. It should be understood, however, that selection region 300 may include portions of selection region 520, and vice versa.

[0089] Selection area 520 may include an outer or first set of selection areas 528. As discussed above, selection area 528 may include a lowest or bottom position 532 and multiple steps, each step rising a selected distance relative to each other and relative to the base or bottom position 532. Thus, the outer steps or selection area 528 may include the base or bottom position 532 and four steps of different heights or an upper surface at different distances relative to the base 532. Steps or selection areas 532-540 allow the rotating body 472 to be positioned at various heights relative to the cap or sealing area 494, similar to the alternative distances discussed above.

[0090] Selection area 520 may also include an inner selection area 560. The inner selection area 560 may also include multiple selection areas 564, 568, 572, 576, and 580. Similar to the outer selection area 520, the individual inner selection portions 564-580 of the inner selection area 560 may also differ from each other in height.

[0091] The outer selection region 520 can cooperate with the outer protrusion 504, and the inner selection region 560 can cooperate with the inner selection protrusion 508 of the rotating body 472. Therefore, the rotating body 472 can engage with the two protrusions 504 and 508 of the two different selection regions 520 and 560, respectively. This allows the rotating body 472 to be rotatably fixed relative to the housing 434 in a manner superior to engagement of the single protrusion 334 of the rotating body 254 with the single selection ring or portion 300 of the box 120 discussed above.

[0092] Furthermore, the rotating body 472 may be defined or formed with a closed surface and does not include a channel for engaging the protrusions of the housing 434. In addition to the selected areas 520, 560, the housing 434 may also include a rotationally engaged or retaining area 600. The rotationally retaining area 600 may also be referred to as a rotating body guide or indicator guide to engage an indicator or radial protrusion 604 of the rotating body 472. The radial protrusion or indicator 604 may extend radially from the outer wall 608 of the rotating body 472. The indicator 604 may be received or engaged by a channel or slot 612 defined between two inwardly projecting walls or protrusions 616, 618. The inwardly projecting walls 616, 618 may protrude a selected distance from the inner surface 622 of the housing 434. Thus, the indicator guide or slot 612 may engage the indicator 604 to rotatably retain the rotating body 472 relative to the housing 434 or to assist in rotatably retaining the rotating body. In this manner, the rotating body 472 can be rotatably fixed or held within the housing 434 by a plurality of mechanisms, including height selection portions 520, 560 that engage corresponding protrusions 504, 508 of the rotating body 472, and the indicator 604 engages in one of a plurality of slots 612 of the indicator guide portion 600. Therefore, it should be understood that the indicator guide 600 may include a plurality of slots 612 that can be aligned with the indicator 604 at each different selection point in different selection areas of the selection portions 520, 560.

[0093] The housing assembly 420, including the rotating body 472, can selectively bias a sealing ball or member 464 into a sealing region 494. As illustrated by example, the outer protrusion 520 may include a selected height 630 relative to the base or lowest portion 532. The inner region 560 may include a similar or equivalent height. Thus, the inner protrusion 508 and the outer protrusion 504 can respectively engage selected regions of the selected regions 520 and 560 to position the spring engagement surface 490 at a selected distance from the sealing region 494 of the sealing portion 460. As discussed above, the compression of the spring and thus the biasing force are changed by varying the distance of the surface 490 relative to the sealing region 494. Therefore, the force required to move the ball 464 away from the sealing region 460 in the direction of arrow 650 can be varied or selected.

[0094] As discussed above, selection areas 520, 560 can be used to adjust the rotating body 472 relative to the sealing position 494 in the seal 460. Additionally and / or alternatively, the cap 446 can be rotated by the interaction of the external thread 450 and the internal thread 442 to move the cap 446 in the direction of arrow 650 and / or arrow 654, thereby adjusting the force applied to the sealing member 464. As discussed above, the pitch of the threads 450, 442 can be selected to allow adjustment of the sealing position 494 relative to the rotating body 472, an adjustment less than the height of the corresponding step in selection areas 520, 560, similar to that discussed above in the housing assembly 120. Therefore, the housing assembly 420 can also be used to select the opening pressure of the valve mechanism 430 within the housing assembly 420, similar to the selection within the housing assembly 120 discussed above, but with variations as discussed above.

[0095] Go to Reference Figure 11A , Figure 11B , Figure 12 and Figure 13 The diagram illustrates box assembly 720, which will be further described herein. Box assembly 720 may include various parts similar to those discussed above, and details of similar or identical parts will not be repeated in detail herein; however, reference can be made to the preceding discussion. Therefore, it should be understood that the various parts of box assembly 720 may be similar to or interchangeable with the parts described above, and may be used as supplements to and / or substitutes for those parts, and vice versa.

[0096] The box assembly 720 may include a box housing 724, which is similar to the box housings discussed above, such as the box housing 190 of box assembly 120. The box housing 720 may include an outer wall or outer wall 728 and may define an internal thread 732, which is also similar to the internal threads discussed above. The box assembly 720 may also include a cap 736, which may define or include an external thread 740. An inlet 744, similar to the inlet 124 of box assembly 120, may be formed through the cap 736. Therefore, the box assembly 720 may include a cap member 736 that can engage with the box housing 724 and define an internal volume or portion 748. The box assembly 720 (such as the box assembly in box housing 724) may also include an outlet 132 and a connection portion 162. Therefore, the box assembly 720 may include portions similar to those discussed above, and may include various portions as further discussed herein.

[0097] The box assembly 720 may also include a valve mechanism 760. The valve mechanism 760 may include portions similar to those discussed above. A rotating body 764 may be included in the valve mechanism 760, which includes a spring seat surface 768 that may engage a biasing member, such as an adjusting spring 772. The adjusting spring 772 may engage or rest on the surface 768 and further abut against a valve or sealing member, such as a valve ball 776. The valve sealing member 776 may engage a sealing portion or area 780 defined by a cap 736, which is similar to a sealing area as discussed above. The ball 776 may include the outer dimensions that engage the sealing area 780 at a sealing position 784 in a sealed or closed configuration. As discussed above, the adjusting spring 772 may bias the sealing ball 776 generally in the direction of arrow 790 onto the sealing surface 780.

[0098] The valve mechanism 760 may also include a return spring 794, which can be engaged by a cap 736 to help hold the rotating body 764 in a selected position within the housing 724. Furthermore, a sealing member 798 (such as a gasket or O-ring) may be positioned between the cap 736 and the housing 724 to help maintain or create a seal between the cap 736 and the housing 724, thereby sealing or substantially enclosing the internal volume 748 within the housing assembly 720.

[0099] The box assembly 720 includes a rotating body 764. For example... Figure 11A and Figure 11B As illustrated, the body of revolution 764 may have a non-curved or rounded outer edge. The body of revolution 764 may include an outer edge or geometry that may be a polygon comprising one or more facets (such as multiple substantially straight or flat edges 790). In various embodiments, the body of revolution 764 may include five edges 790, 794, 798, 802, and 806. Each of the edges 790-806 may engage an inner wall surface of the housing 724. For example, as... Figure 12 As illustrated, housing 724 may include a complementary number of walls 810, 814, 818, 822, and 826. Therefore, housing 734 may substantially define a pentagonal recess or internal shape that is complementary to the external pentagonal shape of the rotator 764. The complementary non-circular shape may assist in holding the rotator 764 at a selected rotational position within housing 724.

[0100] As discussed above, the housing may also include an opening pressure selection portion, such as one or more selection areas. For example, housing 724 may include an external selection area 830 and an internal selection area 834. However, it should be understood that only a single selection area may be provided, and the two selection areas are merely exemplary. Similarly, as discussed above, external selection area 830 may include a selected number of portions with different heights that can change the axial position of the rotating body or its position relative to the sealing position 784. In various embodiments, for example, five positions may be formed, including a first position 840, a second position 844, a third position 846, a fourth position 848, and a fifth position 850. Similarly, internal selection area 834 may include five selection positions, such as a first internal selection position 860, a second position 864, a third position 868, a fourth position 872, and a fifth position 876. Each of the corresponding positions of external selection area 830 and internal selection area 834 may engage or contact a corresponding external leg or protrusion 900 or internal leg or protrusion 904. As discussed above, the protrusions 900 and 904 can extend a selected distance from the bottom surface 910, which is opposite to or opposite to the spring engagement surface 768.

[0101] Furthermore, similar to the selection areas discussed above, the height of each step in the respective steps of the corresponding outer selection area 830 and inner selection area 834 relative to the base portion can be different. For example, as... Figure 12 As illustrated, the first portion 840 may be the base or bottom layer of the housing 724, and the first step 844 may include a selected height or distance 914 above or away from the surface 840 of the first portion 840. Each of the other portions or steps may include a selected distance from the previous or other selected step, and thus may engage the corresponding protrusions 900, 904 at different or varying heights relative to the sealing area 784.

[0102] Therefore, as discussed above, the rotating body 764 is rotatably positioned within the housing 724 to change the position of the spring engagement surface 768 relative to the bottom surface of the housing 724 and the sealing position 784 of the sealing area 780. When the rotating body 764 is selectively positioned, the spring engagement surface 768 can move substantially in the direction of arrow 790 to reduce the spring distance of the adjusting spring 772. When the spring distance decreases (i.e., the spring is compressed), the biasing force applied to the sealing ball 776 can increase, and therefore, greater pressure is required to open the valve mechanism 760 by the material flowing substantially in the direction of arrow 920 into the inlet 744.

[0103] Furthermore, the rotating body 764 may include an indicator or protrusion 930. This indicator or protrusion may be positioned in one or more recesses 934 or alignment recesses 934 formed between each of the wall surfaces 810, 814, 818, 822, 836. Although the housing 724 is understood to include multiple recesses 934, for clarity of the present discussion, only a single recess is discussed here. This recess may be provided to further rotatably secure the rotating body 764 within the housing 724. Thus, once the rotating body 764 is selectively positioned within the rotating body at a selected rotational position, the indicator 764 may be received within the recess 934 to assist in securing the indicator 764 within the housing 724.

[0104] Furthermore, markings may be provided within the housing 724 to aid in identifying the opening pressure based on the positioning of the rotating body. For example, an indicator arrow or marking 940 may point to or guide a selected recess in the recess 934. Additionally, markings or indicators 944 may be provided to provide a specific indication of the opening pressure that will be achieved or selected on the indicator 930, which is positioned in the recess 934 and indicated by the arrow 940. Thus, during assembly, when the rotating body 764 is positioned at a selected location within the housing 724, the user can understand the selected location or opening pressure. This selected location can select or define a threshold or opening pressure for the valve mechanism 760, similar to the threshold or opening pressure discussed above.

[0105] Furthermore, as discussed above, final calibration can be performed by rotating the cap 736 within the housing 724. As discussed above, the interaction between the internal thread 732 and the external thread 740 allows for fine adjustment of the opening pressure between the steps due to the position of the rotating body 764 within the housing 724.

[0106] The rotating body 764 can be held in a selected position by a return spring 794 or other suitable mechanism, generally axially in the direction of arrows 790, 920. As discussed above, the rotating body 764 can also and / or alternatively be bonded or fixed within the housing 724. In various embodiments, for example, a solvent can be applied to the rotating body 764 and / or the housing 724 to bond the tube in the selected position. The solvent can then evaporate and allow the rotating body 764 to be permanently bonded within the housing 724. Furthermore, the positioning of the rotating body 764 relative to the housing 724 can be performed at a selected time, such as during manufacturing, immediately before or during implantation, or at another suitable time.

[0107] Go to Reference Figure 14A , Figure 14B , Figure 15 and Figure 16The diagram illustrates box assembly 1020. Box assembly 1020 may include parts similar to those discussed above, such as box assembly 120. Therefore, similar or identical parts will not be described in detail; however, variations or additional and / or alternative parts will be described in detail.

[0108] Generally, the housing assembly 1020 may include a housing 1024, which includes an outer wall portion or a body 1026. The outer wall portion 1026 may define an internal thread 1028 and an internal volume 1030. The internal volume 1030 may include a volume of CSF, as discussed above. In addition, the housing may include a connection portion 162 and an outlet 132.

[0109] The box assembly 1020 may include a cap 1040 defining an inlet 1044, similar to the inlet discussed above. Therefore, selected material can be filled into the box housing 1024 through the cap 1040 and inlet 1044. Furthermore, the cap 1040 includes an external thread 1048 that engages with the internal thread 1028 of the box housing 1024. Thus, the cap 1040 can be fully engaged with the box housing 1024.

[0110] In various embodiments, the threaded connection of the external thread 1048 and the internal thread 1028 can form a seal to seal the volume 1030. In various embodiments, the threaded engagement of the threads 1028, 1048 can form a coiled or zigzag seal. However, in various embodiments, such as those discussed above and / or alternatives thereof, a sealing member 1052 may be provided to assist in sealing or substantially enclose the volume 1030 when the cap 1040 is placed on the housing 1024. However, according to various embodiments, including those discussed above and further discussed herein, the sealing member 1052 may not be necessary or required, taking into account the interaction between the external thread 1048 and the internal thread 1028 and / or the sealing material positioned at the point of thread interaction.

[0111] The housing assembly 1020 also includes a valve mechanism 1060. The valve mechanism 1060 may include an adjusting member, also referred to as a rotating body 1064, which includes or defines a spring engagement surface or regulator engagement surface 1068. The spring engagement surface 1068 may engage or hold a biasing member relative to the cap 1040, which may be an adjusting spring 1072. The spring 1072 may engage or hold a sealing member 1076, such as a ball seal, relative to the cap 1040, which defines or forms a sealing region 1080. The sealing region 1080 defines a sealing position 1084, which is similar to the sealing position discussed above. Therefore, the pressure regulating spring 1072 may use a biasing force or spring force to hold the sealing member or ball 1076 relative to the sealing region 1080 until the inlet pressure (generally in the direction of arrow 1088) overcomes the force applied by the spring 1072 to allow fluid or material to flow into the housing 1024 (such as within volume 1030).

[0112] The amount of force required to move the sealing member 1076 out of the sealing position 1084 (i.e., the threshold pressure) can be adjusted by changing the force applied by the adjusting spring 1072 (e.g., by selecting the compression of the spring 1072). The housing 1024 may include or define an internal adjustment or selection area, which includes one or more adjustment areas similar to those discussed above. In various embodiments, the housing 1024 may define an external adjustment area 1090 and an internal adjustment area 1094. The external adjustment area 1090 may include a selected number of steps or variable heights relative to a first adjustment position 1098, or a selected number of steps or variable heights from that first adjustment position to a selected number of other steps or positions (e.g., for four other positions out of a total of five positions, including 1100, 1104, 1108, and 1112). Similar to the adjustment areas discussed above, for example, a height difference may exist from the first area 1098 to the second area 1100. This height difference may be a height or a distance 1116. The height 1116 allows the rotating body surface 1068 to be moved closer to the sealing area 1084 and reduces the height of the spring 1072, thus increasing the spring force applied to the sealing ball 1076. Therefore, similar to the discussion above, the positioning of the rotating body further away from or closer to the sealing position 1084 changes the force required to open the sealing ball 1076 from the sealing position 1084 and the seal 1080.

[0113] The adjustment area in the box assembly 1024 may further include a second adjustment area 1094. This second adjustment area may further include a selected number of adjustment positions, such as five adjustment positions 1130, 1134, 1138, 1142, and 1146. Each of these adjustment positions may be positioned at a different height equivalent to the height of the first adjustment position or portion 1090.

[0114] Adjustment positions 1090, 1094 can be engaged or contacted via one or more protrusions from the rotating body 1064. The rotating body 1064 may include a first protrusion 1150, which may be an external protrusion, and a second protrusion 1154, which may also be referred to as an internal protrusion. Each of the protrusions 1150, 1154 extends a distance 1158 from surface 1162. Surface 1162 is generally opposed to surface 1068 of contact spring 1072. Thus, when the protrusions 1150, 1154, or any suitable number of protrusions, contact one or more selected portions of one or more adjustment areas 1090, 1094, the rotating body 1064 can move closer to or further away from the sealing position 1084, and thus adjust or select the pressure applied to the sealing member 1076 by the adjusting spring 1072. However, due to the adjusting spring 1072, the sealing member or ball 1076 can be moved out of the seal 1080 to allow fluid inflow.

[0115] The rotator 1064 can be secured within the housing 1024 in a selected manner, including those discussed above, such as by using retaining springs, adhesive, or other suitable connections. In various embodiments, the rotator 1064 may snap-fit ​​into the housing 1024 as a supplement to or alternative to the retaining system discussed above.

[0116] The body of revolution 1064 may include a selected shape, such as a polygonal shape including a selected number of sides, as exemplarily illustrated, including five sides 1180, 1184, 1186, 1188, and 1190. Thus, the shape of the body of revolution 1064 may be substantially pentagonal. However, it should be understood that the body of revolution 1064 may be formed in any suitable shape, such as any suitable polygonal shape including a selected number of sides. The body of revolution housing may include a complementary number of walls to engage or interact with the body of revolution 1064, thereby holding the body of revolution 1064 in a selected rotational position. In various embodiments, for example, a first wall 1200 and a second wall 1204 may engage either an edge of the body of revolution 1064 or both of the walls. It should be understood that the body of revolution housing 1024 may include any number of walls to engage the body of revolution 1064, and the discussion of the two walls 1200, 1204 is merely exemplary. In various embodiments, for example, five walls may be provided to interact with the five edges of the body of revolution 1064. Between the respective walls may be a recess or recess 1206 that can interact with indicator 1210. The indicator may engage in the recess 1206, similar to indicator 930 discussed above. Other markings, such as indicator mark 1214, may be provided to indicate a selected pressure or position of the rotating body 1064 within housing 1024.

[0117] One or more walls, or any other wall, of walls 1200 and 1204 may include one or more slots or ridges. For example, wall 1200 may include a first slot 1220 and second wall 1204 may include a second slot 1224. An edge, such as edge 1184, may be received in slot 1224, and edge 1186 may be received in slot 1220. Thus, indicator 1210 may be held within recess 1206. Thus, rotator 1064 may snap into housing 1024.

[0118] In various embodiments, for example, the rotator 1064 may be formed of a material that can elastically deform during insertion into the housing 1024. Selected materials may include thermoplastics such as polypropylene, acetal, polysulfone, or polyethersulfone, combinations thereof, and / or copolymers thereof. During insertion, as the rotator moves into the housing 1020, edges 1184, 11186 may deflect and then move into slots 1220, 1224.

[0119] Additionally, additional tools or mechanisms can be used to assist in holding the rotating body 1064 during insertion. For example, assembly tool 1240 may contact or engage tool engagement holes or recesses, such as the first hole 1230 and the second hole 1234 of the rotating body 1064. Tool 1240 may include a first tip 1244 and a second tip 1246 that engage the corresponding holes or recesses 1230, 1234 to allow a press-fit or force generally in the direction of arrow 1250 to press the rotating body 1064 into the housing 1024. Indicator 1210 may be aligned with one or more recesses (such as recess 1206), and tool 1240 may engage in holes 1230, 1234 to press the rotating body 1064 into the housing. Edges may elastically deform and then engage or relax into corresponding slots, such as slots 1220 and 1224. The rotating body 1064 can be rotatably and axially held within the housing 1024 thereafter. Thus, the rotating body 1064, engaging selected adjustment areas 1090 and / or 1094, can define a position relative to the sealing position 1084 to generate a spring force or biasing force against the sealing member 1076.

[0120] Similarly, as discussed above, the rotating body according to various embodiments, including rotating body 1064, can be fixed within the housing 1024 to select a fixed and selected opening pressure that causes the sealing ball 1076 to move substantially in the direction of arrow 1088. Therefore, rotating body 1064 can snap into a slot, as discussed above.

[0121] Furthermore, the cap 1040, including the external thread 1048, can move relative to the internal thread 1028 to adjust the force applied to the sealing ball 1076. As discussed above, the thread interaction allows for fine adjustments due to the movement of the cap 1040 generally in the direction of arrow 1088 and / or arrow 1260. The movement of the cap 1040 relative to the rotating body 1064 can fine-tune or adjust the pressure on the ball 1076 and the force applied by the adjusting spring 1072 through adjustments that are finer than those made to the adjustment zones 1090, 1094, due to distances such as distance 1116.

[0122] Go to Reference Figure 17 As discussed above, according to various embodiments, an adjusting biasing member 1280 may be provided in the valve mechanism, which includes the adjusting spring or biasing member discussed above. In various embodiments, as discussed above, a rotating body or other mechanism may be used to adjust the amount of compression, such as by a height or spring force applied by the biasing member relative to the seal or sealing position. According to various embodiments, the length of the biasing member 1280 may be adjustable as a supplement to and / or alternative to the rotating body. For example, as... Figure 17 As illustrated, the biasing member 1280 may include a first height 1284 and / or a second height 1288. The second height 1288 is greater than the first height 1284 of the biasing member 1280. Due to the greater height or free length of the biasing member 1280, the force exerted by the biasing member 1280 relative to any fixed base position or distance from the sealing position relative to the sealing position can be increased. Therefore, the opening or releasing force of the sealing mechanism can be increased by simply increasing the free length or height (such as the length 1288 relative to the first length 1284).

[0123] In various embodiments, a single spring or biasing member may be provided for mounting into multiple different valve mechanisms, such as valve mechanism 60. The opening or actuating force can be selected or achieved by elongating or stretching the biasing member 1280 (such as a regulator spring) to one of a plurality of selected links. In various embodiments, for example, a first length 1284 may include a first opening pressure of the valve mechanism or provide a first opening force for the valve mechanism. Stretching the biasing member to a second length 1288 may include a different second opening pressure or achieve a different or second opening pressure. Therefore, in various embodiments, the opening pressure or force required to open the valve mechanism can be adjusted or achieved by selecting or forming a spring or biasing member 1280 of a selected length. Achieving the selected length may include stretching or compressing the spring after it has been formed.

[0124] While an adjustable bias or spring member 1280 may be provided as a supplement and / or alternative to using a rotating body to achieve a selected force on the sealing member, as discussed above, in various embodiments, the use of adjustment of the spring member 1280 may be used alone and / or substantially alone to adjust or select the opening force applied or required by the opening valve member.

[0125] Based on the various implementation plans, continue to refer to Figure 17 And refer to other sources Figure 18A , Figure 18B and Figure 19 The diagram illustrates a box assembly 1320. Box assembly 1320 may include portions similar to those discussed above, such as those in box assembly 120. Therefore, box assembly 1320 may include a box housing 1324, which includes an outer wall 1328 that may define or form an internal thread 1332. Furthermore, a cap 1336 may include or form an external thread 1342. The external thread 1342 may threadedly engage the internal thread 1332. The interaction between the cap 1336 and the housing 1324 may form or define a box volume 1346. Additionally, as discussed above, the threaded interconnection of the external thread 1342 with the internal thread 1332 may form a seal to seal or define the volume 1346. However, in various embodiments, additional sealing members, such as O-rings or seals 1350, may be provided between the cap 1336 and the box housing 1324 to assist in sealing the cap 1336 to the housing 1324.

[0126] Furthermore, the box assembly 1320 may include or define a sealing mechanism 1356. The sealing mechanism 1356 may include, be defined by, or be formed by an adjusting spring 1280. As discussed above, the adjusting spring 1280 may be stretched or provided at a selected height, such as height 1284 and / or height 1288. The sealing mechanism 1356 may also include a sealing member, such as a sealing ball 1360. The sealing ball 1360 may engage a seal 1364, which may be a conical or truncated conical portion. The seal 1364 may be a truncated cone. Furthermore, the sealing member 1360 may have a sealing position 1366 similar to the sealing position discussed above. Therefore, the height of the biasing member 1280 may be stretched to select the force applied to the sealing member 1360 between the spring contact surface 1370 of the cap 1336 and the sealing position 1366.

[0127] like Figures 18A to 19As illustrated, the biasing member 1280 can directly contact the cap 1336, for example, at surface 1370. Therefore, the opening force for moving the sealing member 1360 from the sealed position 1366 can be provided by the height of the biasing member 1280 when contacting the cap 1336. According to various embodiments (including those discussed above), the housing 1324 may define an inlet 1374 that allows fluid to enter generally in the direction of arrow 1378. The biasing member 1280 can hold the sealing member 1360 against the seal 1364 until the force overcomes the biasing force of the spring member 1280. However, as discussed above, the housing assembly 1320 does not need to include an additional rotating body or adjustment mechanism. According to various embodiments, a rotating body may be used as a supplement and / or alternative to selecting the height of the biasing or spring member 1280.

[0128] Furthermore, the threaded engagement of the external thread 1342 and the internal thread 1332 is operable to move the surface 1370 generally away from the sealing position 1366 in the direction of arrow 1378 or toward the sealing position 1366 in the direction of arrow 1380. Therefore, by tightening or loosening the cap 1336, further adjustments can be made to the force applied to the sealing member 1360, as discussed above.

[0129] In addition, such as Figures 18A to 19 As illustrated, inlet 1374 may be formed through housing 1324 instead of cap 1336. Seal 1364 may also be formed at housing 1324 instead of cap 1336. Therefore, according to various embodiments, inlet may be positioned relative to sealing member 1360 at any suitable location.

[0130] The biasing member 1280 can also be secured to the cap 1336 at surface 1370 in a suitable manner. For example, the biasing member 1280 can be adhered to the cap 1336, such as by an adhesive or other bonding material or system. In various embodiments, for example, the biasing member 1280 can be bonded to the cap 1336 by providing a solvent that dissolves selected portions of the cap 1336, and the spring 1280 is thereby bonded to the cap 1336.

[0131] Continue to refer to Figure 17 And refer to other sources. Figure 20A , Figure 20B and Figure 21The diagram illustrates a housing assembly 1420. Housing assembly 1420 may include portions similar to or identical to those discussed above, and those portions will not be discussed in more detail here. Therefore, housing assembly 1420 may be included in valve assembly 60 as a supplement to and / or replacement of the housing assembly discussed above. Housing assembly 1420 may include a housing housing 1424, which includes an outer wall 1428 defining an internal thread 1432. Furthermore, housing housing 1424 may include connection portions 132 and 162. Housing assembly 1420 may include a cap or top 1434 defining or forming an inlet 1438. The cap 1430 may define an external thread 1442. The external thread 1442 may threadedly engage the internal thread 1332 of housing housing 1424.

[0132] The interaction between the cap 1434 and the housing 1424 of the box assembly can form or define a volume 1446. As discussed above, according to various embodiments, the threaded interaction of the threads 1432, 1442 can seal the volume 1446 at least through the cap edge 1434. However, in various embodiments, an additional sealing member 1450 may also be provided between the cap 1434 and the housing 1424. Thus, fluid can flow through the box assembly 1420 through the inlet 1438 and the outlet 132.

[0133] Additionally, the box assembly 1420 may include a valve mechanism 1454. As discussed above, the valve mechanism 1454 may include a biasing member 1280. The biasing member 1280 may generate a biasing force against the sealing member 1458 by selecting or forming its length or free length.

[0134] Valve mechanism 1454 includes a sealing member 1458 that can be held or engaged in a seal 1462. The sealing member 1458 can be sealed within the seal 1462 at a sealing position 1466. The length or height of the biasing member 1280 can achieve or form a sealing force, which is the closing force of the sealing member 1458 into the seal 1462. As discussed above, the seal 1462 can be formed as a cone or a truncated cone, such that the sealing member 1458 can be pressed into the seal 1462 using the adjusting or biasing member 1280.

[0135] like Figures 20A to 21 As illustrated, the biasing member 1280 can be fixed or held to the spring engagement surface 1470 within the housing 1424. Therefore, as discussed above, the biasing member 1280 can be used alone or substantially alone to achieve a selected opening or closing force of the sealing member 1458 from the seal 1462. As discussed above, a rotating body can be used to adjust the position of the biasing member 1280 relative to the sealing position 1466; however, according to various embodiments, such a rotating body is not required.

[0136] The biasing member 1280 can be bonded to the mating surface 1470 in a suitable manner (including those discussed above). The biasing member 1280 can be adjusted to a selected free height, such as height 1284 and / or height 1288, to achieve a selected opening force, thereby allowing material to flow through the inlet 1438 generally in the direction of arrow 1474. Therefore, the cassette assembly 1420 does not need to include a rotating body, but can instead include the technical features discussed above. The opening force can be further adjusted or tuned by the threaded engagement of the cap 1434 with the cassette housing 1424. As discussed above, moving the cap 1434 by the threaded engagement or interaction can move the cap 1434 generally in the direction of arrow 1474 and / or in the direction of arrow 1478 to adjust or select the pressure applied to the sealing member 1458 in the cassette assembly 1420.

[0137] Therefore, according to various embodiments, as discussed above, a housing assembly may be provided in valve assembly 60. Furthermore, also as discussed above, various housing assemblies may include various features that are interchangeable or alternative to each other. A rotating body may or may not be provided to achieve a selected opening pressure, provided that the opening pressure can be selected, for example, by individually adjusting the length of the spring or individually adjusting the length of the biasing member. However, a rotating body may be provided to allow selection of a specific opening pressure, such as effective selection. Specific selection may allow the use of similar or multiple parts to form valve assemblies with several selected opening pressures and / or different opening pressures. Other mechanisms, such as the free length of threaded cap adjustment and / or spring adjustment, may allow fine-tuning and / or more precise selection or adjustment of the opening pressure.

[0138] As discussed above, the number of protrusions of the rotating body interacting with the selection area can be provided in an appropriate manner to select or maintain a selected height or position of the rotating body within various housings. Additionally, a rotating body with an appropriate geometry can be provided to interact with the housing, thereby achieving rotational and / or axial positioning to maintain the selected position of the rotating body in order to maintain a selected pressure or height of the biasing member (also referred to as an adjusting spring or member) within the housing assembly.

[0139] In various embodiments, as discussed above, valve assembly 60 may include an inlet 80 and an outlet 84. The inlet 80 and outlet 84 may be along axis A ( Figure 2 Generally aligned and / or coaxial. In various embodiments, a cartridge assembly (such as cartridge assembly 120) may include a valve mechanism or cartridge inlet 124 generally along or having a central axis B, and an outlet 132 may extend along axis C. Axis B may not be aligned with axis C. In various embodiments, as illustrated above, axis B may be substantially orthogonal to axis C. Therefore, according to various embodiments, at least one of the inlet or outlet of the cartridge assembly may not be aligned with axis A.

[0140] As discussed above, a valve assembly 60 may be provided in the shunt assembly 10 to assist in providing selected flow and / or pressure within the ventricles of a subject. In various embodiments, the valve assembly 60 may include a housing, such as housing 120, according to various embodiments discussed above. However, in various embodiments, the valve assembly 60 may include additional and / or alternative housing assemblies. For example, as... Figure 22 , Figure 23 , Figure 24 , Figure 25 and Figure 26 The diagram illustrates valve assembly 1560. Valve assembly 1516 may include parts similar to or the same as those discussed above, which will only be briefly discussed here. In short, and referring back to the reference... Figures 1 to 4 Valve assembly 1560 may include an inlet 1564, a passage 1568, a reservoir 1572, a flow-limiting chamber assembly 1576 including a chamber cover 1580 and a chamber flow control 1584, and an outlet 1588. Valve assembly 1560 may also be positioned on a sheet or cover 1592. Therefore, valve assembly 1560 may include various parts similar to those discussed above, such as those discussed in valve assembly 60.

[0141] However, valve assembly 1560 may include a housing assembly 1620 positioned within a cover or dome 1574. Housing assembly 1620 may be similar in various features to the housing assemblies discussed above, such as housing assembly 120. However, housing assembly 1620 may generally be elongated, such as... Figure 24 The cassette assembly 1620 may include an outlet 132 in a connection portion 162 for interconnection with a flow-limiting portion 1584 within a cover 1580. Furthermore, the cassette assembly 1620 may be held within a cassette receiving portion 1624 of the base 1626 of the valve assembly 1560. A cassette receiving section 1624 may be formed to receive a portion of the cassette assembly 1620, such as an inlet or a first side or portion 1628.

[0142] Continue to refer to Figures 22 to 24 And specifically refer to Figure 25 and Figure 26 The cartridge assembly 1620 is discussed and illustrated in more detail. The cartridge assembly 1620 may extend generally along axis 1629 and has portions aligned with respect to the axis, as discussed herein. The cartridge assembly 1620 may include a cap 1640, which may include an inlet or define an inlet 1644. The inlet 1644 may allow fluid to flow into the cartridge assembly 1620 generally in the direction of arrow 1646 along axis 1629. The inlet 1644 may be located near or help define a seal or support 1650.

[0143] A sealing member (such as ball 1654) may be positioned or biased into the seal or support 1615 by a biasing member 1658. Ball 1654 may seal at a sealing position 1662 in the seal 1655, thereby positioning ball 1654 within the seal 1650. Biasing member 1658 may generally bias ball 1654 generally at the sealing position 1662 in the seal 1650 in the direction of arrow 1666. Biasing member 1658 may be positioned between outlet members 1670, which define or form a biasing member contact surface 1674 to contact biasing member 1658.

[0144] The outlet member 1670 may also define an external thread 1678, which can thread-engage an internal thread 1682. The cap 1640 may be rotatably movable relative to the outlet member 1670 to move in the directions of arrows 1646 and / or 1666. The movement of the cap 1640 relative to the outlet member 1670 may selectively compress the biasing member 1658 to achieve or select a free height and / or a spring force or biasing force applied to the seal 1650 by the biasing member 1658 against the sealing member 1654. Therefore, the position of the cap 1640 relative to the outlet member 1673 may select the force of the opening pressure to move the sealing member 1654 away from the sealing position 1662.

[0145] As discussed above, a housing assembly (such as housing assembly 120) can be used to select the opening or opening pressure of the valve mechanism 1560. The valve mechanism 1680 of housing assembly 1620 may include a sealing portion 1650, a sealing member 1654, and a biasing member 1658. Therefore, rotating the cap 1640 relative to the outlet member 1670 can axially position the cap 1640 relative to the outlet member 1670 and select the biasing force applied to the sealing member 1654. This biasing force can select or implement a selected opening force to select the opening pressure or opening pressure (i.e., threshold pressure) of the sealing member 1654 relative to the housing assembly 1620 of the valve assembly 1560. Therefore, a separate rotating body is not required to select the opening pressure.

[0146] The cartridge assembly 1620 may also include a sealing member 1684, such as an O-ring. The sealing member 1684 may be positioned between the cap 1640 and the outlet member 1670 to seal the cartridge volume 1688 within the cartridge assembly 1620. The cartridge volume 1688 may be confined between the caps 1640 in the outlet member 1670 and may be accessed through the inlet 1644 as the sealing end 1640 moves away from the sealing position 1662.

[0147] Once the opening pressure is selected and achieved (e.g., by positioning the cap 1640 relative to the outlet member 1670), the cap 1640 can be secured relative to the outlet member 1670 in an appropriate manner. As discussed above, various mechanisms can be used to secure the cap assembly or member 1640 to the outlet member 1670, such as adhesives, sonic welding, bonding, etc. In various embodiments, the cap member 1640 can be bonded to the outlet member 1670 at a selected location. Thus, once secured, the box assembly 1620 can be secured at a selected location and under bias force to achieve a selected inlet pressure for the box assembly 1620. The box assembly 1620 can then be assembled into the valve assembly 1560, as discussed above, and further assembled into the diverter assembly 10.

[0148] As discussed above, valve assembly 1560 may have a cover 1574. This cover may have a maximum external dimension 1690 that is approximately 1 mm to approximately 5 mm smaller than the minimum external dimension 1690 of valve assembly 1560 between its maximum size position and outlet 1588. Therefore, during possible modifications, according to various embodiments, valve assembly 1560 can be removed via a single cut.

[0149] Go to Reference Figure 27 , Figure 28 and Figure 29The diagram illustrates valve assembly 1760. Valve assembly 1760 may include portions similar to those discussed above, such as those in valve assembly 60. Valve assembly 1760 may include various additional and / or alternative portions as further discussed herein. For example, valve assembly 1760 may include an inlet 1764 and a flow-limiting chamber assembly 1768. Flow-limiting chamber assembly 1768 may include an outlet 1772 and a flow-limiting chamber portion 1776, as well as a chamber cover 1780. Valve assembly 1760 may also include a reservoir volume 1780 defined or formed by cover 1784. Cover 1784 may include a material similar to the cover of the dome of valve assembly 60 discussed above. Furthermore, valve assembly 1760 may include an inlet member 1786 leading into flow-limiting chamber assembly 1768. Inlet 1786 generally allows fluids (such as CSF) to flow generally in the direction of arrow 1790. Furthermore, inlet 1764 allows fluid to flow generally in the direction of arrow 1794. Valve assembly 1760 may also include a housing assembly 1820. Housing assembly 1820 may include inlet 1824 and outlet member 1826 forming or defining outlet 1828. Outlet 1828 and inlet 1776 may be covered or connected by connecting member 1832. Furthermore, housing assembly 1820 may be held or covered by cover member 1784. Thus, valve assembly 1760 may be a substantially linear or elongated valve assembly. Valve assembly 1716 may include portions similar to those discussed above, such as valve assembly 60. Furthermore, valve assembly 1760 may include replaced portions, or portions that replace and / or supplement valve assembly 60 discussed above. However, valve assembly 1760 may be included in a flow divider assembly, as discussed above, and further discussed herein.

[0150] The valve 1760, including the housing assembly 1820, may include portions similar to those of housing assemblies (such as housing assembly 120) discussed above. The housing assembly 1820 may define or include a valve mechanism including a cap 1824 that defines or forms an internal thread 1826. The internal thread 1826 may engage in an external thread 1830 of an outlet and / or member 1834. The cap 1824 may thread-engage the outlet member 1834 with the thread 1830 to move the cap 1824 generally in the direction of arrow 1838 and / or 1842. The housing assembly 1820 may also include a sealing portion or member, such as a ball member 1846. Furthermore, the housing assembly 1820 may include a biasing member 1850. The biasing member 1850 may abut against a seal or support 1854 to hold or bias the sealing member 1846 at a sealed position 1858. The sealing position 1858 can be the location of the ball 1846 sealing the box assembly 1820 (such as the box volume 1860). Similarly, a threaded connection can close the box by a selected amount, and / or a sealing member 1863 (such as an O-ring) can also be included in the box assembly 1820.

[0151] The sealing member 1846 can be moved away from the sealing position 1858 by the force of a fluid (such as CSF) moving generally in the direction of arrow 1842. As discussed above, for example, the cap member 1824 can be moved relative to the outlet member 1834 to select the compressive force or length of the bias member 1850. Thus, the bias member 1850 can apply a force to the sealing member 1846 to seal the box assembly 1820. The position of the cap 1824 relative to the outlet member 1834, in which the bias member 1850 is located, can be used to achieve or select the opening or opening force required to move the sealing member 1846 away from the sealing position 1858 and allow fluid (such as CSF) to flow generally in the direction of arrow 1842 and out to the outlet 1772.

[0152] As discussed above, once a selected opening or closing force is generated or achieved, the cap 1824 can be bonded to the outlet member 1834. The bonding of the cap 1824 to the outlet member 1834 can be similar to the bonding discussed above. The cap 1824 can be fixed to the outlet member 1834 by force, sonic welding, solvent bonding, etc. However, the box assembly 1820 can be used to achieve or select the opening or closing pressure within the valve assembly 1760.

[0153] Valve assembly 1760 may include a maximum external dimension 1890, which is approximately 5 mm larger than a minimum external dimension 1894. Therefore, valve assembly 1760 may be "V" shaped. Valve assembly may also, or alternatively, include a third external dimension 1898, which is similar to the maximum external dimension 1890, such as being 2 mm smaller. Therefore, valve assembly 1760 may be a number "8" or dumbbell shaped. Thus, valve assembly 1760 may include small dimensions and selected external volumes, such as for positioning in a small region or within a subject's body.

[0154] In various embodiments, as discussed above, valve assembly 60 may include inlet 1564 and outlet 1588. Inlet 1564 and outlet 1588 may be along axis C ( Figure 23 Generally aligned and / or coaxial. In various embodiments, the housing assembly (such as housing assembly 1620) may include a valve mechanism or housing inlet 1644 generally along or having a central axis E, and an outlet 132 may extend along axis F. Axis E may be aligned with axis F. Therefore, all axes D, E, and F may be substantially aligned. In various embodiments, axes D, E, and F may be substantially aligned along axis 1629.

[0155] As discussed above, the shunt assembly 10 may include valve assembly 60 or valve assembly according to various embodiments discussed herein. Valve assembly may include various features or portions, including all features or portions discussed herein, all features or portions provided alternatively or additionally to each other, or features or portions according to various embodiments of the cassette assembly discussed herein. Therefore, the various embodiments discussed herein are not necessarily mutually exclusive unless indicated above. Thus, the shunt assembly 10 may be provided in a subject to achieve a selected opening pressure or to have a selected opening or shut-off pressure to allow or select the flow of CSF from the subject's ventricles. Various valve assemblies may be used to achieve a selected fixed opening pressure once selected during manufacturing and / or prior to implementation. In various embodiments, as discussed above, valve assemblies including selected cassette assemblies may be used to select the opening or shut-off pressure within the valve assembly for the shunt assembly to achieve a selected outcome and / or treatment for the subject.

[0156] As discussed herein, the biasing member, according to various embodiments, can be a helical spring, leaf spring, compliant, or deformable member. Therefore, biasing members can be provided and implemented to provide a selected biasing force on the sealing member to enter the sealing portion or support. The sealing member may also include a sphere, a curved surface member, a conical member, or other suitablely shaped member capable of sealing and unsealing relative to the seal or support.

[0157] Example embodiments are provided to make this disclosure thorough and to fully communicate the scope of this disclosure to those skilled in the art. Numerous specific details, such as examples of particular components, apparatus, and methods, are set forth to provide a thorough understanding of embodiments of this disclosure. It will be apparent to those skilled in the art that specific details are not required, example embodiments may be embodied in many different forms, and should not be construed as limiting the scope of this disclosure. In some example embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.

[0158] The foregoing description of embodiments has been provided for illustrative and descriptive purposes. The foregoing description is not intended to be exhaustive or limiting of this disclosure. Elements or features of a particular embodiment are generally not limited to that particular embodiment, but are interchangeable and may also be used in selected embodiments where applicable, even if not specifically shown or described. The same element or feature may be varied in many ways. Such variations should not be considered as departing from this disclosure, and all such modifications are intended to be included within the scope of this disclosure.

Claims

1. A shunt system configured for placement within a subject, comprising: Entrance; exit; A reservoir in a fluid flow path from the inlet to the outlet, wherein fluid is operable to flow into the inlet, through the reservoir, and out of the outlet; and A valve mechanism, positioned between the inlet and the outlet, controls the flow rate from the inlet to the outlet to a selected threshold pressure, wherein the valve mechanism includes, The housing has at least one adjustment area. An adjusting member having: a first side and an adjusting portion, wherein the adjusting portion is configured to engage the at least one adjusting region; The second side is opposite to the first side and has an offset member support. A return spring, configured to operably engage with the adjusting member, the return spring being positioned in a groove formed in the adjusting member, the return spring biasing the adjusting member within the housing; A sealing member, configured to seal the diversion system when positioned in a sealed position, and A biasing member configured to bias the sealing member at the sealing position with a selected biasing force. The bias force is selected at least in part by the position of the adjusting member relative to the sealing position; The adjusting member has a circular outer wall that is operable to rotate within the circular inner wall of the housing.

2. The diversion system of claim 1, wherein the housing includes a central protrusion and the adjusting member includes a central opening; wherein the adjusting member is at least partially rotatably fixed by the interaction of the central protrusion and the central opening.

3. The diversion system of claim 2, wherein the protrusion comprises a polygonal outer shape and the central opening has a complementary polygonal inner wall shape; The interaction between the outer shape of the polygon and the complementary inner wall shape of the polygon allows the adjustment member to be rotatably fixed in multiple positions within the housing.

4. The diversion system according to claim 1, wherein the housing includes an inner wall having a recess; The adjusting member includes an outer wall and a protrusion extending from the outer wall; The protrusion is configured to be held within the recess to rotatably hold the adjusting member.

5. The diversion system according to claim 4, wherein the recess comprises a plurality of recesses; The protrusion is configured to be selectively held in each of the plurality of recesses.

6. The diversion system according to claim 1, wherein the at least one adjustment area includes at least an external adjustment area and an internal adjustment area.

7. The diversion system according to claim 1, wherein the adjustment area comprises a first portion and a second portion; The adjusting portion of the adjusting member is configured to engage both the first portion and the second portion; The adjusting member moves closer to the sealing position when engaged on the second portion than when engaged on the first portion.

8. The diversion system according to claim 7, wherein the adjustment area further comprises at least a third part, a fourth part, and a fifth part; The adjusting portion of the adjusting member is configured to engage at least one of the first portion, the second portion, the third portion, the fourth portion, or the fifth portion to set the distance of the biasing member support relative to the sealing position.

9. The diversion system of claim 8, wherein the force for opening the sealing member from the sealed position is set by the relative position of the bias member support with respect to the sealed position.

10. The diversion system of claim 8, wherein each of the first portion, the second portion, the third portion, the fourth portion, or the fifth portion has a surface at a different distance from the sealing position.

11. The diversion system according to claim 1, further comprising: A top member configured to cover a selected portion of the housing; and A sealing portion, the sealing portion defining the sealing position relative to the top member; The top member defines the valve mechanism inlet.

12. A method of providing a shunt system configured for placement within a subject, the method comprising: Provide an entry point; Provide export; A reservoir is provided in the fluid flow path from the inlet to the outlet, wherein fluid is operable to flow into the inlet, through the reservoir, and out of the outlet; as well as A valve mechanism is provided positioned between the inlet and the outlet to control the flow rate from the inlet to the outlet to a selected threshold pressure, wherein the valve mechanism... include, A positioning adjustment member having: an adjustment portion defining at least one adjustment region within a housing and a first side thereof, wherein the adjustment portion is configured to engage the at least one adjustment region; The second side is opposite to the first side and has an offset member support. The sealing member is positioned between the adjusting member and the sealing position, wherein the sealing member is configured to seal the diversion system when positioned in the sealing position. A positioning biasing member is configured to bias the sealing member at the sealing position with a selected biasing force. The second biasing member is placed in a slot formed in the adjusting member, and the second biasing member biases the adjusting member into the housing; as well as The adjustment member is rotated to a selected position relative to the adjustment area within the housing to select the bias force; The adjusting member has a circular outer wall that is operable to rotate within the circular inner wall of the housing.

13. The method of claim 12, wherein positioning the adjusting member comprises engaging a central protrusion of the housing with a central opening of the adjusting member; The adjusting member is at least partially rotatably fixed by the interaction of the central protrusion and the central opening.

14. The method of claim 13, further comprising: The central protrusion comprises a polygonal outer shape and a central opening having a complementary polygonal inner wall shape; The interaction between the outer shape of the polygon and the complementary inner wall shape of the polygon allows the adjustment member to be rotatably fixed at multiple locations within the housing.

15. The method of claim 13, further comprising: The protrusion extending from the outer wall of the adjusting member engages with the recess formed in the circular inner wall of the housing; The engagement between the protrusion and the recess rotatably holds the adjusting member.

16. The method of claim 13, further comprising: Provide at least a first portion and a second portion to the adjustment area; as well as The adjusting portion of the adjusting member is engaged with at least one of the first portion or the second portion to position the biasing member support at a predetermined distance from the sealing position.

17. The method of claim 16, further comprising: By engaging the first portion with the adjustment portion of the adjustment member, the biasing member generates a larger bias force than by engaging the second portion with the adjustment portion of the adjustment member.

18. The method of claim 13, further comprising: The housing is at least partially enclosed by a top member, the top member being configured to cover a selected portion of the housing; as well as Provides a housing inlet through the top member and a sealing portion defining the sealing position relative to the housing inlet.

19. A shunt system configured for placement within a subject, comprising: A reservoir in a fluid flow path from inlet to outlet, wherein fluid is operable to flow into the inlet, through the reservoir, and out of the outlet; and A valve mechanism, positioned between the inlet and the outlet, for controlling the flow rate from the inlet to the outlet to a selected threshold pressure, wherein the valve mechanism includes, The housing has at least one adjustment area. An adjusting member having: a first side and an adjusting portion, wherein the adjusting portion is configured to engage the at least one adjusting region; The first side is opposite to the second side and has an offset member support, wherein the adjusting member has a circular outer wall operable to rotate within the circular inner wall of the housing. A sealing member, configured to seal the diversion system when positioned in a sealed position, and A biasing member configured to bias the sealing member at the sealing position with a selected biasing force. A return spring, configured to operably engage with the adjusting member, the return spring being positioned in a groove formed in the adjusting member, the return spring biasing the adjusting member within the housing; A rotary fixing system comprising at least one of the following: (i) a central protrusion in the housing and a central opening through the adjusting member, or (ii) a recess in the circular inner wall and a radial protrusion from the adjusting member, the radial protrusion being operable to engage the recess; The rotary fixing system is configured to rotatably fix the adjusting member relative to at least a portion of the housing and the at least one adjusting region.

20. The diversion system according to claim 19, wherein the at least one adjustment region includes a first adjustment region and a second adjustment region.

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