JP7262876B2 - An electronic toolset for use with multiple generations of implantable programmable valves with or without fixed reference magnet-based orientation capability - Google Patents

Description

The present invention relates to systems and methods for implantable drainage valves for drainage of bodily fluids (eg, cerebrospinal fluid). In particular, the systems and methods of the present invention relate to an electronic toolset for suggesting and adjusting with automatic switching between multiple generations of implantable fluid drainage valves with and without orientation capability.

Hydrocephalus is the retention of cerebrospinal fluid in the brain as a result of increased production or, more commonly, fluid pathway obstruction or reduced absorption. Cerebrospinal fluid (CSF) shunting has been used for decades to treat hydrocephalus. CSF shunt surgery involves establishing an alternative pathway for CSF migration to bypass the natural pathway blockage.

This shunt is positioned to allow drainage of CSF from the ventricle or subarachnoid space into another absorption site (eg, the right atrium of the heart or the abdominal cavity) via a system of small catheters. A regulating device, such as a valve, may be inserted into the passageway of the catheter. Generally, valves keep CSF flowing away from the brain, modulating pressure or flow. A drainage system using catheters and valves can drain excess CSF in the brain, thereby reducing intracranial pressure.

Some implantable valves are fixed pressure valves (ie, monopressure valves) and others have adjustable or programmable settings. A programmable or adjustable implantable valve is desirable in that the valve pressure setting can be non-invasively changed via an external control device over the course of treatment without the need for an explant. One such conventional adjustable or programmable implantable valve using magnets is assigned to DePuy Orthopedics, a J&J company associated with the present assignee, and is incorporated herein by reference in its entirety. CODMAN® HAKIM® Programmable Valve (CHPV), as disclosed in US Pat. No. 4,595,390. Another programmable implantable drainage valve is CODMAN ( ® CERTAS® or CERTAS® Plus Programmable Valve. Medtronic also has a programmable implantable shunt valve Strata® that is controlled using magnets. The pressure settings in these aforementioned conventional programmable implantable valves can be adjusted non-invasively after implantation in the body using a rotating structure or rotor with a pair of magnets.

Each programmable implantable valve is controlled using an associated external toolset comprising one or more devices used to locate the valve, read current valve settings, and adjust valve settings. An associated toolset may be required with each improved generation or version of the programmable implantable valve. However, the electronic toolsets used to suggest and adjust the latest generation programmable implantable valves are often inoperable on earlier generations or versions of programmable implantable valves. As a result, medical personnel are advised to keep multiple versions of the electronic toolset (i.e., not only the latest improved version, but also the previous version) and to use each electronic toolset with only compatible programmable implantable valves. Proper use is required. Moreover, the generation of the valve implanted in the patient on which to base the selection of the appropriate toolset is not always clear from patient records or radiographic identification.

U.S. Patent No. 4,595,390 U.S. Patent No. 8,322,365

Thus, for use in suggesting and adjusting multiple generations or versions of programmable implantable valves that allow automatic switching between generations of valves with or without orientation capability without additional input by the clinician. It would be desirable to develop a universal or compatible electronic toolset for

One aspect of the present invention is the suggestion of multiple generations or versions of programmable implantable valves that allow automatic switching between generations of valves with or without orientation capability without additional input by the clinician. and a universal or interchangeable electronic toolset for use in conditioning.

Another aspect of the present invention is an implantable programmable fluid drainage valve, whether or not the implantable programmable fluid drainage valve includes a fixed reference magnet used to determine the orientation angle of the implantable programmable fluid drainage valve. , wherein the implantable programmable fluid drainage valve comprises an adjustable valve unit having a pair of primary magnet elements. A magnetic field detection sensor array within an indicator tool of the electronic toolset is used to determine whether a fixed reference magnet is present within the implantable programmable fluid drainage valve. When the presence of a fixed reference magnet within the implantable fluid drainage valve is detected, the center of the adjustable valve unit is located using the indicator tool of the electronic toolset and the flow direction of the adjustable valve unit is determined. , is confirmed based solely on electronic feedback provided by the indicator tool of the electronic toolset, without the need for manual physical palpation, the indicator tool of the electronic toolset confirming that the located center of the adjustable valve unit and Aligned with the flow direction, the current valve setting is read using the indicator tool of the electronic toolset. In contrast, if the presence of a fixed reference magnet within the implantable fluid drainage valve is not detected, the center of the adjustable valve unit is located using the indicator tool of the electronic toolset and the position of the adjustable valve unit. Flow direction is established by manual physical palpation only, without electronic feedback from the indicator tool of the electronic toolset, which is aligned with the localized center and flow direction of the adjustable valve unit. The aligned and current valve settings are read using the indicator tool of the electronic toolset.

Yet another aspect of the invention is an implantable programmable fluid drainage valve comprising an implantable programmable fluid drainage valve having an adjustable valve unit comprising a pair of primary magnet elements for programming the implantable programmable fluid drainage valve to a desired valve setting. It relates to a programmable bodily fluid drainage valve system. The system also includes a versatile electronic toolset for suggesting and adjusting the implantable programmable fluid drainage valve. Therein, a general purpose electronic toolset includes a magnetic field detection sensor array to (i) detect a pair of primary magnet elements and (ii) determine the presence or absence of a fixed reference magnet within an implantable programmable fluid drainage valve. an indicator tool having A circuit is provided for determining the center of the adjustable valve unit based on the sensed pair of primary magnet elements. Such a circuit determines the angular orientation of the implantable programmable fluid drainage valve solely by electronic feedback from the toolset in the presence of a fixed reference magnet, but in the absence of a fixed reference magnet, the manual body motion. A step is generated on the implantable programmable fluid drainage valve display for determining the angular orientation and/or center of the implantable programmable fluid drainage valve by palpation alone.

The foregoing and other features of the invention will become more readily apparent from the following detailed description and drawings of examples of the invention. Like reference numbers denote like elements throughout the drawings.

FIG. 10 is a schematic exploded perspective view of a programmable implantable valve device having a fixed reference magnet in addition to a rotating primary magnet associated with an adjustable valve unit; 2 is an exploded perspective view of the adjustable valve unit of FIG. 1; FIG. 3 is a top view of the adjustable valve unit of FIG. 2; FIG. Figure 4 is a side cross-sectional view of the adjustable valve unit of Figure 3 along line 4-4; FIG. 4 is a side view of a single rotor tooth in engagement with a single lock stop; 5 is a cross-sectional view of the adjustable valve unit of FIG. 3 along line 5-5; FIG. Figure 6 is a partial cross-sectional view of the adjustable valve unit of Figure 4 taken generally along line 6-6 at a first pressure setting; 6A is a deeper cross-sectional view of the adjustable valve unit of FIG. 4 generally along line 6A-6A at the first pressure setting; FIG. 5 is a partial cross-sectional view of the adjustable valve unit of FIG. 4 at one of various series of pressure settings; FIG. 5 is a partial cross-sectional view of the adjustable valve unit of FIG. 4 at one of various series of pressure settings; FIG. 5 is a partial cross-sectional view of the adjustable valve unit of FIG. 4 at one of various series of pressure settings; FIG. 5 is a partial cross-sectional view of the adjustable valve unit of FIG. 4 at one of various series of pressure settings; FIG. 5 is a partial cross-sectional view of the adjustable valve unit of FIG. 4 at one of various series of pressure settings; FIG. 5 is a partial cross-sectional view of the adjustable valve unit of FIG. 4 at one of various series of pressure settings; FIG. 5 is a partial cross-sectional view of the adjustable valve unit of FIG. 4 at one of various series of pressure settings; FIG. FIG. 5 is a partial cross-sectional view of the adjustable valve unit of FIG. 4 at an exemplary first pressure setting showing arrows marked on the programmable valve device indicating the direction of fluid flow therethrough and a fixed reference magnet; FIG. 6I is a top view of the programmable valve device of FIG. 1 with the adjustable valve unit at the same first pressure setting shown in FIG. 6I, and also showing the flow directions marked by arrows and the positioning of the fixed reference magnet. 7 is a deeper cross-sectional view of the adjustable valve unit of FIG. 4 along line 7-7; FIG. FIG. 8 is a cross-sectional view of the adjustable valve unit of FIG. 7 showing transitions to different pressure settings; FIG. 10 is a perspective view of a spring arm unit with optional torsion springs; FIG. 10 is a top plan view of the elements of FIG. 9; 10 is a side cross-sectional view of the adjustable valve unit of FIG. 8 taken along line 10-10 showing axial elevation of the rotatable structure; FIG. 6H is a shallower partial top cross-sectional view of the adjustable valve unit of FIG. 6H showing the "substantially OFF" position in an unrestrained condition; FIG. 12 is a side view along line 12-12 of FIG. 11; FIG. 13 is a side cross-sectional view along line 13-13 of FIG. 11; FIG. 13A is a partial cross-sectional view taken along line 13A-13A of FIG. 13; FIG. FIG. 12 is a perspective view of a toolset comprising an integrated locator/indicator tool, an adjustment tool, and a screwdriver; 15 is a top perspective view of the integrated locator/indicator tool and adjustment tool of FIG. 14 before the adjustment tool is inserted into the integrated locator/indicator tool; FIG. 15 is a top perspective view of the integrated locator/indicator tool and adjustment tool of FIG. 14, with the adjustment tool inserted into a complementary cavity within the integrated locator/indicator tool; FIG. 15 is an exploded perspective view of the integrated locator/indicator tool of FIG. 14; FIG. 15 is an exploded perspective view of the adjustment tool of FIG. 14; FIG. 17 is a perspective view showing the placement of semi-circular magnets on opposite sides of a magnetic shield comprising part of the magnet assembly of FIG. 16; FIG. 17 is a perspective view of the assembled magnet assembly of FIG. 16; FIG. 17 is a top view of the assembled lower and middle housing sections of the adjustment tool of FIG. 16 showing internal vertical ribs; FIG. 15 is a perspective view of the assembled adjustment tool of FIG. 14 with the outer housing section removed to show the magnet assembly; FIG. Fig. 3 shows one of a series of steps for operating an electronic toolset according to the invention; Fig. 3 shows one of a series of steps for operating an electronic toolset according to the invention; Fig. 3 shows one of a series of steps for operating an electronic toolset according to the invention; Fig. 3 shows one of a series of steps for operating an electronic toolset according to the invention; Fig. 3 shows one of a series of steps for operating an electronic toolset according to the invention; Fig. 3 shows one of a series of steps for operating an electronic toolset according to the invention; Fig. 3 shows one of a series of steps for operating an electronic toolset according to the invention; Fig. 3 shows one of a series of steps for operating an electronic toolset according to the invention; Fig. 3 shows one of a series of steps for operating an electronic toolset according to the invention; The implanted valve is either a current valve with orientation capability according to the present invention (i.e. using a fixed reference magnet) or a previous version implanted valve without orientation capability (i.e. a fixed reference magnet). It is a flow chart of a method for confirming whether a magnet is not used).

FIG. 1 shows a programmable shunt valve device 10 having a shunt housing 12 preferably formed from a translucent material such as silicone along with proximal and distal connectors 14,16. A ventricular catheter or other proximal catheter is connectable to connector 14 for carrying fluid into shunt housing 12 . Fluid is directed into the sampling or pumping chamber 18 and then through the valve mechanism in the inlet 102 and into the adjustable valve unit 100 . This is shown and described in more detail below in connection with FIGS. 2-13A. The adjustable valve unit 100 (see FIG. 1) comprises a casing 103 formed as an upper casing 104 and a lower casing 106 which in this configuration are joined by sonic welding. A needle guard 20, preferably formed from a rigid polymeric material, and a lower casing 106 are secured within housing 12 by a backing plate 22, preferably formed from silicone reinforced with a polymeric mesh, which backing plate 22: It is bonded to housing 12 with medical grade epoxy. A fixed reference magnet 800 , as described in more detail below, is preferably mounted on a bump or protrusion 801 on needle guard 20 .

When the fluid pressure at inlet 102 exceeds a selected pressure setting within adjustable valve unit 100 , fluid enters over the valve mechanism and then flows through valve unit outlet 110 and into passageway 30 of housing 12 . Ultimately, the fluid exits housing 12 through distal connector 16 and into a peritoneal or other distal catheter.

Adjustable valve unit 100 (see FIG. 2) comprises rotor 120 , spring arm unit 130 , valve mechanism 140 and rotor retention spring 150 . Rotor 120, also referred to as a rotating structure, includes a lower cam structure 122 having a plurality of radially flat cam surfaces and magnet elements 123, which are north and south pole magnets, respectively, as shown and described in more detail below. and an upper magnet housing 124 carrying 125 . Housing 124 also defines fingers 127 that engage a stop within upper casing 104 when rotor 120 is moved to an unrestrained condition, as described below. Rotor 120 rotates within casing 103 about axle 126 defining a substantially fixed rotational axis R at a first position.

Preferably, the rotor 120 is also allowed to move along the axis of rotation in translation to an unconstrained condition when an adjustment tool of the electronic toolset is applied, as described in more detail below. be. A retention spring 150 biases the rotor 120 downward to its normal restraint condition. Preferably, the spring 150 is sufficient to resist the effects of gravity regardless of the position of the adjustable valve unit 100 and within the integrated locator/indicator tool of the electronic toolset, as described in more detail below. A coil spring with sufficient biasing force to resist magnetic or ferromagnetic objects such as magnets. However, spring 150 is insufficient to resist the effects of the adjustment tool, which is further described below. The lower cam section 122 has sufficient height to ensure that the cam follower 132 remains in contact with the cam surface in both constrained and unconstrained conditions.

A spring arm unit 130 comprises a cam follower 132 , a resilient spring element 134 and an upper axle 136 and a lower axle 138 at a second position on the casing 103 . Axle 138 pivots about bearing 139 formed from a relatively low-friction, relatively hard material such as synthetic ruby. Casing 103, rotor 120, and spring arm unit 130 are preferably formed from polyethersulfone, and all spring components are formed from medical grade non-ferromagnetic stainless steel.

Valve mechanism 140 includes seat 142 and movable valve member 144 . Preferably, seat 142 and valve member 144, such as a ball, are formed from the same non-ferromagnetic material, such as synthetic ruby. In other configurations, the movable valve member 144 can be disc-shaped, conical, or other types of plugs. A spherical ball is currently preferred as the movable valve member. This is because the shape allows for close and precise tolerances, assembly and control of the valve seat. Also, the position of the seat within the port can be adjusted during assembly of the valve unit to change the actual performance values achieved at each setting using the force-displacement relationship. First, the mandrel locates the ball and the seat is inserted into the presumed desired position within the port. Ball displacement is tested at one or more settings to confirm that the desired performance is achieved.

Adjustable valve unit 100 is shown assembled in FIGS. 3-5 and positioned at a second pressure setting as described in greater detail below. Rotor housing 124 carries downwardly projecting teeth 160 and 162 that cooperate with four locking stops 170, 172, 174, 176 projecting upwardly from lower casing 106 in this configuration. Lock stop 172 is shown in partial cross-section in FIG. 4, and lock stops 170 and 176 are visible in FIG. Preferably, the lower surfaces 161 of the rotor teeth 160 and 162 are circular and the upper surfaces of the casing lock stops 170, 172, 174, and 176, respectively, are arranged so that the rotor teeth are in the restrained position, as shown in the side view of FIG. 4A. It has a plurality of facets 163 to form a chisel-like lead-in shape that aids in rebounding. However, when engaged, the vertical surfaces of rotor teeth 160, 162 and lock stops 170-176 abut and do not "pull out", ie, prevent relative translational movement as also shown in FIG. 4A. Therefore, pure vertical lift to overcome rotor tooth-to-lock stop abutment and change performance settings must be accomplished by an adjustment tool as described in more detail below.

A limiter 180 (see FIG. 4) limits movement of the spring 134 away from the seat 142 so that the ball 144 does not become misaligned or misaligned with respect to the seat 142 . Epoxy gasket 182 is shown in FIGS. 4 and 5 as an optional redundant seal between upper casing 104 and lower casing 106 in this configuration.

The operation of the adjustable valve unit 100 is illustrated in FIGS. 6-8, like reference numerals indicating like components and features. Not all such components and features are marked in each figure for visual clarity. Figures 6 and 6A are top partial cross-sectional views at different elevations for the adjustable valve unit 100 at the first pressure setting. Cam follower 132 is a first cam surface having an arc length bounded by points 190 and 192 because rotor housing teeth 162 are trapped between casing lock stops 170 and 172 under normal restraint conditions. Sliding contact with 191 only. First cam surface 191 has a first, preferably shortest, radial distance 210 from the axis of rotation of rotor 120 . By comparison, outermost cam surface 205 has maximum radial distance 218 . An optional torsion spring 220 is shown in more detail in FIG.

As the rotor 120 is translated upward by the magnets using the adjustment tool, the rotor teeth 162 are pulled up such that subsequent clockwise or counterclockwise rotation of the adjustment tool causes the rotor teeth 162 to move upward. rotates upward on the casing lock stopper 172 . After the adjustment tool is removed and the second pressure setting is selected as shown in FIG. 6B, rotor 120 is biased downward by spring 150 (see FIGS. 2, 4 and 5). reference).

For example, in FIGS. 4 and 6B, rotor tooth 160 is trapped between a pair of adjacent lock stops 172 and 174 (see FIG. 6B) in a restrained condition, which is the cam structure of rotor 120. Sufficient to prevent rotation of the rotor 120 relative to the cam follower 132 beyond points 192 and 194 above is shown as not being in contact with any stops. Points 192 and 194 correspond to a second arc length of second cam surface 193 . Surface 193 is located at a second radial distance 212 that is longer than distance 210 and shorter than distance 218 (see Figures 6A and 6H). The arc length of the second cam surface 193 (see FIG. 6B) can be the same or different than the arc length of the first cam surface 191, but is preferably substantially the same length.

Outer radial motion of cam follower 132 produces high torque on the cam follower as it slides from first cam surface 191 (see FIG. 6A) to second cam surface 193 (see FIG. 6B). Applied by 132 against the remainder of the spring arm unit 130 increases the biasing force of the valve spring 134 against the ball 144 . Improved pressure control accuracy is achieved by placing a rigid cam follower 132 in contact with a selected cam surface and a flexible element or spring 134 in contact with a valve ball 144 . An improvement in performance is the opening of ball 144 from valve seat 142 by only requiring bending of resilient spring element 134 (which exerts a constant spring force on ball 144). Opening pressure and overall valve performance are independent of spring arm unit 130 pivoting.

A third opening pressure setting is shown in FIG. 6C, in which rotor tooth 162 is positioned only on third cam surface 195 between point 194 and point 196 where cam follower 132 is located at third radial distance 214. is positioned between casing stops 174 and 176 so as to cover the To achieve the fourth pressure setting (see FIG. 6D), both rotor teeth 160 and 162 are used against casing stops 170 and 176 respectively. Cam follower 132 is thereby confined to fourth cam surface 197 between points 196 and 198 .

6E-6G, the fifth pressure setting when rotor teeth 160 are continuously trapped between each of the casing's adjacent lock stop pairs 170-172, 172-174, and 174-176. to the seventh pressure setting are shown. Cam follower 132 is thereby placed on fifth cam surface 199 between points 198 and 200 (see FIG. 6E) and on sixth cam surface 201 between points 200 and 202 (see FIG. 6E). 6F), and a seventh cam surface 203 between points 202 and 204 (see FIG. 6G).

Here, the preferred opening pressure settings range from about 30 mm water column to 210 mm water column (294 Pa to 2,059 Pa) in seven 30 mm water column (294 Pa) increments, with the final "substantial off" setting being detailed further below. is explained. Preferably, each valve unit is calibrated and tested at one or more flow rates during manufacture. The actual opening pressure for each setting tends to vary with flow rate, which is typically measured in milliliters/hour. Also, when tested with a 120 cm long distal catheter with an internal diameter of 1 mm, the average opening pressure typically increases by more than 9 millimeters of water column at flow rates of 5 ml/h and above.

A final setting (see FIG. 6H) of at least about 400 mm of water (3,920 Pa) minimizes flow as a "substantially off" setting, ie substantially closed. This final setting is achieved by exposing the cam follower 132 to the outermost cam surface 205 defined by points 204 and 206 having a maximum radial distance 218 . This maximum cam setting forces the stiffening element 133 of the spring arm unit 130 against the valve spring 134 to shorten the effective length of the valve spring 134, thereby exerting a biasing force against the ball 144. increases dramatically. The final opening pressure increases by more than 50% over the previous setting. In other configurations, the stiffening element is pressed against the valve spring during two or more final cam settings at the desired pressure increments.

9 and 9A, spring arm unit 130 is shown in more detail with cam follower 132, stiffening element 133, and valve spring . Cam follower 132 terminates in a triangular head 233 with rounded or beveled edges, one of which serves as bearing surface 235 . In a preferred construction, spring element 134 is formed from stainless steel having a thickness of 0.020 inches and terminates in an enlarged pad 230 for contacting the valve ball or other movable valve member. In one configuration, spring element 134 is attached to the remainder of spring arm unit 130 by post 232 and rivet 234 secured by ultrasonic welding. Torsion spring 220 has a first leg 221 retained within recess 236 of protrusion 238 . A second leg 223 rests against the inner surface of the casing.

The use of torsion spring 220 is optional and possible since only spring element 134 contacts the movable valve member. As a result, additional spring force from torsion spring 220 can be used to press bearing surface 235 of cam follower 132 against the cam surface of the rotor. This biasing force provided by the torsion spring 220 enhances the rotational position of the spring arm reflecting the intended cam displacement without a force otherwise being applied to the ball or other movable valve member. This reduces the need to maintain minimum friction, such as when the valve spring element alone provides the force required to maintain the cam follower on the cam surface, thus making it more accurate and repeatable. Allows for opening pressure and a more manufacturable and robust design.

The locations of components and features within the adjustable valve unit 100 at the first pressure setting shown in FIG. 6A are shown in FIG. 7 in partial cross-sectional view at greater depth. Apertures 222 into the lower cam portion of rotor 120 prevent negative pressure due to deployment below rotor 120;

8 and 10, from the first pressure setting to the first pressure setting as rotor 120 is translated upward by magnetic attraction using an adjustment tool to allow rotor tooth 162 to move away from casing lock stop 172. A transition to a pressure setting of 2 is shown. In FIG. 8, cam follower 132 is shown at point 192 where it passes from first cam surface 191 to second cam surface 193 . Lower cam section 122 is positioned high enough relative to cam follower bearing surface 235 to ensure that cam follower 132 remains in contact with the cam surface of cam portion 122 in both bound and unbound conditions. have Rotor retention spring 150 (see FIG. 10) is compressed and its bias is overcome by magnetic attraction between rotor 120 and the adjustment tool while the adjustment tool is positioned on valve unit 100. be. Also shown in FIG. 10 are upper synthetic ruby bearings 242 and lower synthetic ruby bearings 139 for upper axle 136 and lower axle 138 of spring arm unit 130, respectively. Synthetic ruby bearings 240 rotatably support rotor axle 126 .

The location of components and features within valve unit 100 in the final "substantially off" or substantially closed setting shown in FIG. 6H is shown in a shallower cross-section in FIG. 11 in an unrestrained condition. Further clockwise rotation of rotor 120 is prevented by rotation stop or limiter 250 projecting downwardly from upper casing 104 and contacting finger 127 . Rotation stop 250 contacts the opposite surface of finger 127 when rotor 120 is turned fully counterclockwise in an unrestrained condition. The actual position of rotation stop 250 can be shifted to the right of the position shown in FIG. Preferably, one side of the stop 250 prevents direct rotor movement from the lowest setting to the highest setting so that the cam follower contacts the cam lobes for the highest setting when the rotor is at the lowest setting. is also prevented. The other side of stop 250 prevents direct movement from the highest setting to the lowest setting. FIG. 12 shows a side partial cross-sectional view of the rotation stop 250 blocking the rotor housing 124 and the spring 150 compressed between the rotor 120 and the upper casing 104 for this unrestrained condition.

13 and 13A show further details of selected features and components of rotor 120 in one configuration. In particular, housing portion 124 is shown to be integral with cam portion 122, similar to monolithic rotor 120a of FIG. 1A. A pocket cavity 260 (see FIG. 13) houses a magnet 123 and a tantalum reference ball 129, which provides the actual pressure settings during imaging of the valve unit 100 after implantation in a patient. It is easily visible for confirmation. Pocket cavity 262 holds magnet 125 . 13A, a partial end view of housing portion 124 through magnets 125, pockets 262, and rotor teeth 160 is shown.

Therefore, the particular design of the abutting rotor tooth-lockstop vertical surfaces, which requires a mere vertical pull-up by the adjustment tool to overcome the rotor tooth-lockstop abutment to change the pressure setting, Allows prevention of changes in valve settings even during exposure to external magnetic fields. These vertical surfaces are made of sufficiently rigid material (such as moldable plastics such as polyethersulfone (PES), polysulfone (PSU), polyphenylsulfone (PPSU), etc.) as well as sufficient wall thickness to prevent flexing. Rotor tooth-to-lockstop abutment prevents rotational movement from a given performance setting, as it does not introduce any lead-in to encourage upward movement on lockstops constructed from a thickness (greater than 0.2mm). mechanically prevented. Axial movement is limited due to the orientation of the rotating assembly magnets, which induces a combination of attractive and repulsive forces when interacting with strong north or south magnets. In addition, the interference between the axle of the rotating arrangement and the bushing surface mechanically limits the tilt related attraction/repulsion forces to external magnetic fields.

However, the downwardly projecting rotor teeth 160, 162 of the rotor housing 124 have corresponding setting pockets 171, 171′ defined by at least one of the lock stops 170, 172, 174, 176 projecting upwardly from the lower casing 106. , 171'', 171''', the programmable implantable fluid drainage valve resists magnetic fields only when properly locked, engaged, or seated within. The downwardly projecting teeth 160, 162 desirably rest on lock stops 170, 172, 174, 176 as shown in FIG. It is mechanically possible to be placed in a state in which there is no If rotor teeth 160, 162 rest on lock stops 170, 172, 174, 176 (i.e., do not rest properly within their respective set pockets defined by the lock stops), the programmable implantable Fluid drainage valves are at risk of potentially undergoing undesirable changes in valve setting when exposed to magnetic fields, such as during an MRI procedure. Heretofore, conventional programming valves cannot verify whether the rotor teeth 160, 162 are properly seated within the set pockets 171, 171', 171'', 171'''. Experimental tests show that the valve setting remains unchanged when subjected to magnetic fields up to about 3T when the rotor teeth are properly locked, engaged or seated within their respective setting pockets was confirmed. To ensure, prior to exposure to a magnetic field (e.g., prior to undergoing an MRI procedure), programmed valve settings should be reconfirmed by medical personnel using the indicator tool in the associated toolset. or alternatively, a medical personnel must use a tool to confirm proper engagement. Even though the likelihood of occurrence is relatively low, the potential for changes in valve setting when the rotor teeth are not properly seated in the setting pocket during exposure to the magnetic field remains a particular concern. This is because implantable programmable fluid drainage valves cannot be guaranteed to have resistance to magnetic fields in such environments.

The improved implantable valve drainage system of the present invention determines whether the downwardly projecting rotor teeth 160, 162 are properly seated within their respective seating pockets 171, 171', 171'', 171'''. , i.e., whether the magnetic resistance mechanism is properly engaged to perform its intended function, eliminates this uncertainty.

This configures the programmable shunt valve 10 to include a fixed reference magnet 800 in addition to the primary magnet elements 123, 125 disposed within the housing 124 of the rotor 120 of the adjustable valve unit, as shown in Figure 6I. It is realized by Referring to FIG. 6J, preferably the fixed reference magnet 800 is located between the proximal connector 14 and the sampling/pump chamber 18 in the flow direction of the shunt valve. Preferably, the fixed reference magnet 800 has a different magnetic strength than the primary magnet elements 123, 125 and a different inter-magnet nominal distance (i.e. the distance between the primary magnets 123 and 125 compared to the distance between the primary magnets 123 and 125) for proper identification. the distance between the reference magnet 800 and the primary magnet 123). The nominal distance between primary magnet elements 123, 125 is approximately 5.48 mm measured from the lower inner angle to the lower inner angle. The nominal distance of the fixed reference magnet 800 is 17.5 mm from the RC axle to the leading edge of the reference magnet 800. A fixed reference magnet 800 is aligned with an arrow or mark “A” on the programmable shunt valve 10 itself that indicates the direction of fluid flow therethrough and a center point “C” halfway between magnet elements 123 , 125 . A line through these three points (referred to as the flow direction line) is drawn on the programmable shunt valve 10 using the integrated locator/indicator tool 1405 in the exemplary toolset 1400 in the case shown in FIG. It is the basis for determining orientation. Also included in the toolset are adjustment tools 1415 , screwdrivers 1410 and spare batteries 1408 . It should be noted that the locator tool and indicator tool described herein and shown in the accompanying drawings are integrated into a single device for simplicity of operation. However, none, some, or all of the tools within the toolset are contemplated and are within the intended scope of the invention.

14A shows a top perspective view of integrated locator/indicator tool 1405 and adjustment tool 1415 of FIG. 14B shows adjustment tool 1415 after insertion into cavity 1420. FIG.

15 is an exploded perspective view of the integrated locator/indicator tool 1405 of FIG. 14 with housing 1500. FIG. In the illustrated example, housing 1500 includes a lower housing section 1505, a middle housing section 1510, and an upper housing section 1515, each spaced apart from each other. Cylindrical section 1530 of intermediate housing section 1510 defines a passageway or channel 1535 extending longitudinally therethrough. Upper housing section 1515 has a chimney 1525 complementary in size and shape to be received within passage or channel 1535 of cylindrical section 1530 of middle housing section 1510 . Chimney 1525 is closed at one end and open at the opposite end. An open end of chimney 1525 that receives adjustment tool 1415 therein, as will be described in greater detail below. The outer surface of lower housing section 1505 defines a recess 1520 therein that is complementary in shape and size to the outer contour of the programmable implantable fluid drainage valve. In use, the integrated locator/indicator tool 1405 is positioned with the outer surface of the lower housing section 1505 against the patient's skin and the implantable fluid drainage valve seated within the recess 1520 . A top cover or top layer 1540 may be attached to the top of the assembled housing. Such a cover or layer 1540 has an opening 1542 of complementary size and shape to chimney 1525 . Disposed around the perimeter of opening 1542 is a series of markings representing the individual valve settings in predetermined increments (eg 1, 2, 3, 5, 6, 7, 8). A second opening 1550 in the top cover or top layer 1540 allows a display 1555, such as a liquid crystal display (LCD), to be viewed therethrough. Integrated locator/indicator tool 1405 is powered by one or more batteries and is turned ON/OFF by button 1560 . The batteries are housed in a battery enclosure assembly 1565 that comprises a tray with electronic contacts between which the batteries are inserted. Access to battery enclosure assembly 1565 for insertion/removal of batteries from battery enclosure assembly 1565 is through removable battery door assembly 1575 . A two-dimensional array of three-axis magnetoresistive sensors 1570 printed on the circuit board detects the magnetic field pattern produced by the magnet elements 123, 125 and the fixed reference magnet 800 disposed within the housing 124 of the rotor 120. . It is within the intended scope of the present invention to substitute the triaxial magnetoresistive sensor 1570 with other types of sensor arrays capable of detecting magnetic fields, such as Hall sensors. Another printed circuit board 1573 contains the processor/controller and memory devices.

16 is an exploded perspective view of the adjustment tool 1415 of FIG. 14. FIG. In the illustrated example, housing 1600 includes an outer housing section 1610 and an upper housing section 1615, each spaced apart from each other. A magnet assembly 1620 is disposed within outer housing section 1610 . In particular, the magnet assembly 1620 of FIG. 16A comprises two semi-circular magnets 1630, 1650 linked by a yoke 1650 and separated by a shield magnet 1640 that redirects the magnetic field to allow for greater depth penetration. is an array. The strength of the semi-circular magnets 1630, 1635 selected for use in the adjustment tool 1415 depends on one or more factors such as the distance from the valve and the design of the sensor array. In magnet assembly 1620, two semi-circular magnets 1630, 1635 are rotated until their flat sides lie flush with shield magnet 1640, as shown in FIG. 16A. Preferably, the orientation of the magnets 1640, 1630, 1635 is shown in FIG. 16, with the magnetic north side of the shield magnet 1640 in contact with the semi-circular magnets 1630, 1635, with magnetic north pointing to the bottom of the outer housing section 1610. It should be something like One of the two semi-circular magnets 1630, 1635 faces the tantalum reference ball 129 (see Figure 13). The shield magnet 1640 is partially pushed back by the semi-circular magnets 1630, 1635 and thus by a yoke 1650 attached to the top of the shield magnet 1640, which is also in contact with the two semi-circular magnets 1630, 1635 when assembled. pressed downwards. These components of the magnet assembly 1620 are arranged such that two semi-circular magnets 1630, 1635 are positioned inside the outer housing section 1610 with the semi-circular magnet facing the tantalum ball 129 facing toward the "1-8 stopper". It is inserted into the outer housing section 1610 when assembled together so that it is received within each recess 1655 defined in the surface. As can be seen in the top view of Figure 16C, the outer housing section 1610 comprises a plurality of vertical ribs 1655 connecting the semi-circular magnets 1630,1635. A cylindrical spacer 1625 is positioned above the yoke 1650 (see FIG. 16D). An upper housing section 1615 with marking indicators is secured to the outer housing section 1610 forming an assembled adjustment tool 1415 .

The magnetic field pattern produced by the magnet elements 123, 125 and fixed reference magnet 800 disposed within the housing 124 of the rotor 120 is detected by the two-dimensional array of 3-axis magnetoresistive sensors 1570 of the integrated locator/indicator tool 1405. be. Once these three magnets are detected, the center point "C" midway between the two detected magnet elements 123, 125 is located. The fixed sensed reference magnet 800 is coupled to an arrow or marking "A" on the implantable valve indicating the direction of flow and a center point "C" halfway between the two sensed magnet elements 123, 125. defines a directional flow line as a reference line for aligning the integrated locator/indicator tool 1405 with the flow line direction on the valve. When the user aligns and orients the toolset with respect to this valve mechanism, the toolset provides valve setting suggestions based on magnetic north/south pole angles to facilitate adjustment of the valve settings.

17A-17I are a series of steps in the operation of the improved electronic toolset of FIG. 14 according to the present invention. In FIG. 17A, integrated locator/indicator tool 1405 is turned on by pressing power button 1560 . Holding the power button 1560 for a predetermined time interval, eg, about 3 seconds, calibrates, clears, or zeroes the integrated locator/indicator tool 1405 as shown in FIG. 17B. The lower surface (sensor floor) of the integrated locator/indicator tool 1405 is then positioned against the skin over the implantable valve system such that the implantable valve is positioned in the lower housing section 1505 as shown in FIG. 17C. is received in a recess 1520 of complementary size and shape defined in the exterior surface of the . The integrated locator/indicator tool 1405 indicates that the two circular visual images shown on the LCD display 1555 are aligned with each other so that the center of the adjustable valve unit 100 is aligned with the center of the adjustable valve unit 100. It is moved in the appropriate direction (as indicated by the four arrows each pointing in a different direction) until suggested. Once the locator/indicator tool 1405 has been aligned above the adjustable valve unit 100, then in FIG. 17D the integrated locator/indicator tool 1405 displays two visual icons (implantable valve (keyhole-shaped) are rotated until aligned with each other to orient the integrated locator/indicator tool 1405 in the proper flow direction of the implantable valve. At this time, with the integrated locator/indicator tool 1405 centered and oriented in the flow direction of the implantable valve, the current suggestion or valve setting is loaded and visually displayed on the LCD (Fig. 17E). If the current valve setting is to be changed or programmed to a new valve setting, then in FIG. Rotate until the fiducial marking 1619 on 1415 is aligned with the marking on the upper lens 1540 corresponding to the current valve setting read. In FIG. 17G, the adjustment tool 1415 is rotated clockwise/counterclockwise to the marking on the top lens corresponding to the new valve setting. Once set to the new valve setting, in FIG. 17H the adjustment tool 1415 is removed from the integrated locator/indicator tool 1405 (while the integrated locator/indicator tool 1405 remains stationary in place) and this The new valve setting is automatically detected by the integrated locator/indicator tool 1405 and visually displayed on the LCD 1555 (see Figure 17I). Note that the positioning of the integrated locator/indicator tool 1405 remains unchanged in steps 17E-17I. The improved electronic toolset eliminates the need or need to relocate the center of the valve and then confirm the new valve setting after adjustment by adjustment tool 1415 .

As shown in FIG. 14, the electronic toolset of the present invention is a latest version or latest generation programmable magnet having a fixed reference magnet 800 separate from and in addition to the pair of primary magnets 123, 125 in the adjustable valve unit 100. Suitable for use with implantable valves (see Figure 1). As discussed above, a fixed reference magnet is used to determine the angular orientation of the valve. Other and possibly older generations or versions of programmable implantable valves that do not use a reference magnet separate from and in addition to the pair of primary magnets in the adjustable valve unit may still be in use. . In that case, the angular orientation of the valve cannot be confirmed using the electronic toolset. Of course, generations or versions of programmable implantable valves that do not use a reference magnet still use the toolsets of their corresponding older versions or generations (i.e., to detect a fixed reference magnet and electronically determine the orientation angle based on it). not configured to). However, this requires the availability of various versions or generations of electronic toolsets to accommodate the presence or absence of a fixed reference magnet within the programmable implantable valve. Become. In order to select the appropriate generation or version of the toolset, the user must first identify which version or generation of implantable programmable valve has been implanted. This can be accomplished via X-ray imaging (e.g. determining the presence or absence of a reference magnet), but such exposure has adverse health effects and should therefore be avoided whenever possible. is. Another drawback is that medical facilities require spatial allocations for storing different versions or generations of toolsets. However, by far one of the greatest associated risks is the potential for medical personnel to select and use a generation or version of the toolset that is not compatible with the implanted valve. These risks and drawbacks make the present invention a versatile electronic tool that can be used interchangeably with both programmable implantable valves that use fixed reference magnets and earlier generations or versions of programmable implantable valves that do not have fixed reference magnets. Reduced or overcome by using sets.

Specifically, the locator/indicator tool 1405 of the present invention is used to determine if the fixed reference magnet 800 associated with the adjustable valve unit 100 is detected by the two-dimensional array of 3-axis magnetoresistive sensors 1570. circuit. If the fixed reference magnet 800 is not detected (i.e., does not exist), the system classifies the magnet based on historical valve mechanics and facilitates guidance for locating the valve, but the user does not receive electronic assistance or electronic feedback. It is necessary to determine the orientation by palpation or the like without using the When the user covers the valve mechanism and manually orients the toolset, the toolset provides valve setting suggestions based on the north/south magnetic pole angles to facilitate adjustment of the valve settings.

FIG. 18 illustrates the specific steps taken to determine if the implanted valve 10 is of the generation or version with the fixed reference magnet 800 and the associated operational steps taken in either case. 1 is an example flow diagram of. Specifically, at step 2005 the presence of the fixed reference magnet 800 within the implanted valve 10 is confirmed using a two-dimensional array of 3-axis magnetoresistive sensors 1570 within the integrated locator/indicator tool 1405. be. Once the fixed reference magnet 800 in the implanted valve 10 is detected in step 2010, then in step 2015 the center of the adjustable valve unit 100 is located. Specifically, localization of the center of the adjustable valve unit 100 is first associated with the adjustable valve unit 100 using a two-dimensional array of 3-axis magnetoresistive sensors 1570 within the integrated locator/indicator tool 1405. This is achieved by sensing the primary magnets 123,125. Once the primary magnets 123, 125 are detected, the center of the adjustable valve unit 100 is located halfway between the primary magnets 123, 125 to indicate the center of the adjustable valve unit 100. Next, at step 2020, the valve flow direction is determined based on the located center of the adjustable valve unit 100 (at step 2015) and based on the detected fixed reference magnet 800 (at step 2005). . The integrated locator/indicator tool 1405 is moved until aligned with the specified center of the adjustable valve unit 100, then the tool is rotated to the proper orientation aligned with the specified flow direction of the valve. . Preferably, this is displayed by two separate icons, one fixed valve position icon representing the implanted valve and one movable locator/indicator tool icon representing the integrated locator/indicator tool 1405 . is visually realized on the display screen 1555 where Note that a single icon, hereinafter referred to as a "dual parameter icon", can be used to indicate more than one parameter (eg alignment and flow direction). For example, the dual parameter icon may be an outer circle having a keyhole shape within the outer circle that is complementary to the contour of the programmable shunt valve device 10 of FIG. In this example dual parameter icon, the outer circle corresponds to the alignment parameter, while the keyhole shape within the outer circle indicates the flow direction parameter. The integrated locator/indicator tool 1405 aligns the two icons visible on the display screen 1555 with respect to both the valve center (outer circle alignment) and flow direction (keyhole shape). Moved and properly rotated. At this time, since the integrated locator/indicator tool 1405 is properly centered and the orientation angle is aligned with the valve flow direction, the operation proceeds to step 2025 where the current valve setting indication is the primary magnets 123, 125 Magnetic north/south pole angles are read by the integrated locator/indicator tool 1405 to help adjust valve settings as desired.

If the new electronic toolset is to be used with previous generations or versions of implanted valves that do not use a fixed reference magnet, then in step 2010 the presence of such a fixed reference magnet is used to determine the triaxial reluctance. Not detected by the two-dimensional array of sensors 1570. The process proceeds to step 2030 where the center of the adjustable valve unit 100 is located similar to the process discussed above with respect to step 2015. Specifically, localization of the center of the adjustable valve unit 100 is first associated with the adjustable valve unit 100 using a two-dimensional array of 3-axis magnetoresistive sensors 1570 within the integrated locator/indicator tool 1405. This is achieved by sensing the primary magnets 123,125. Once the primary magnets 123,125 are detected, the center of the adjustable valve unit 100 is located halfway between the primary magnets 123,125. Integrated locator/indicator tool 1405 is moved until aligned with the identified center of adjustable valve unit 100 . Again, preferably this is two separate icons, one fixed valve position icon representing the implanted valve and one movable locator/indicator tool icon representing the integrated locator/indicator tool 1405). is visually realized on the display screen 1555 where is displayed. If the presence of a fixed reference magnet is not detected, the displayed icon (eg outer circle only), representing a single parameter (eg centering). There is no keyhole geometry within the outer circle that indicates the flow direction parameter. This is because such parameters are not electronically detectable with the assistance and feedback of integrated locator/indicator tool 1405 in the absence of fixed reference magnet 800 . Integrated locator/indicator tool 1405 is moved appropriately until the two icons visible on display screen 1555 are aligned with respect to the center (outer circle alignment). Since the fixed reference magnet is not detected and therefore no electronic assistance or electronic feedback information regarding the flow direction line of the implanted valve is provided by the integrated locator/indicator tool 1405, the operator instead selects the adjustable valve unit. center and flow direction, i.e., orientation angle, must be determined manually without electronic assistance or electronic feedback information from any tool in the electronic toolset (visual, auditory through one or more senses, such as physically and/or tactilely). Preferably, the user will be able to cover the implanted valve and manually orient the toolset, i.e., to the center of the implanted valve, without electronic assistance or electronic feedback information provided by the electronic toolset. and how to manually determine flow direction (step 2035), step by step. According to an example based on the configuration of the adjustable valve unit 100 shown, the user may be instructed to palpate the area of interest until the adjustable valve unit 100 is located, then the center is marked. (ie the rigid portion of the valve distal to the reservoir). Also, the location of the inlet and outlet connector barbs of each catheter can be determined by palpation and marking accordingly. A straight line through the three markings then represents the machine direction line. Once the flow direction line is confirmed manually (without electronic assistance or electronic feedback information from any tool in the electronic toolset), the integrated locator/indicator tool 1405 aligns the flow direction line. is manually oriented to Now that the center of the adjustable valve unit 100 has been located and the integrated locator/indicator tool 1405 has been manually aligned with the manually detected orientation of the implanted valve's flow direction. Operation then proceeds to step 2040 where an indication of the current valve setting is read by the integrated locator/indicator tool 1405 based on the north/south magnetic pole angles of the primary magnets 123, 125 to change the valve setting as desired. Adjustment is facilitated. As noted above, when using other valve configurations, the steps for locating the center of the valve and flow direction may differ from those described above by using other fixed reference points on the valve. good too.

Thus, having shown, described and pointed out the basic novel features of the invention as applied to a preferred embodiment of the invention, various omissions in the form and details of the devices shown and their operation have been made. It will be understood that , substitutions, and modifications can be made by those skilled in the art without departing from the spirit and scope of the invention. For example, it is expressly intended that all combinations of those elements and/or steps which perform substantially the same function in substantially the same way to achieve the same results are included within the scope of the invention. . Also, substitution of elements from one described embodiment to another is fully intended and contemplated. Also, it should be understood that the drawings are not necessarily drawn to scale and are, of course, conceptual only. It is the intention, therefore, to be limited only as indicated by the scope of the claims appended hereto.

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

10 programmable shunt valve device, programmable shunt valve, implanted valve
12 shunt housing, housing
14 proximal connector
16 Distal connector
18 sampling chamber or pumping chamber
20 Needle guard
22 backing plate
30 Passage
100 adjustable valve unit, valve unit
102 Entrance
103 Casing
104 upper casing
106 lower casing
120 Rotor
120a monolithic rotor
122 lower cam structure, lower cam section, cam portion
123 magnet element, primary magnet element, primary magnet, magnet
124 upper magnet housing, housing, rotor housing, housing part
125 magnet element, primary magnet element, primary magnet, magnet
126 rotor axle, axle
127 fingers
129 Tantalum Ball, Tantalum Reference Ball
130 spring arm unit
132 rigid cam followers, cam followers
133 stiffening element
134 elastic spring elements, spring elements, springs, valve springs
136 upper axle
138 lower axle, axle
139 Lower Synthetic Ruby Bearing, Bearing
140 valve mechanism
142 valve seat
144 Movable valve member, valve member, valve ball, ball
150 rotor retaining spring, retaining spring, spring
160 downward protruding teeth, rotor teeth, downward protruding rotor teeth
161 lower surface
162 downward protruding tooth, rotor tooth, downward protruding rotor tooth, rotor housing tooth
163 Faceted
170 Casing lock stopper, lock stopper, casing stopper
171 setting pocket, loading pocket
172 Casing lock stopper, lock stopper
174 Casing Lock Stopper, Lock Stopper, Casing Stopper
176 Casing Lock Stopper, Lock Stopper, Casing Stopper
180 Limiter
182 Gasket
190 places
191 first cam surface
192 places
193 second cam surface
194 places
195 Third cam surface
196 places
197 4th cam surface
198 places
199 5th cam surface
200 locations
201 6th cam surface
202 places
203 7th cam surface
204 places
205 outermost cam surface
206 places
210 first radial distance, distance
212 second radial distance
214 third radial distance
218 maximum radial distance, distance
221 1st leg
222 Aperture
223 Second Leg
230 magnifying pad
232 posts
233 Triangle Head
234 Rivet
235 bearing surface, cam follower bearing surface
236 recess
238 Projection
240 synthetic ruby bearing
242 upper synthetic ruby bearing
250 rotation stopper, stopper, limiter
260 pocket cavity
262 pocket cavity, pocket
800 reference magnet, fixed reference magnet
801 bumps or protrusions
1400 toolset
1405 Integrated Locator/Indicator Tool
1408 spare battery
1410 screwdriver
1415 Adjustment Tool
1420 Cavity
1500 housing
1505 lower housing section
1510 intermediate housing section
1515 upper housing section
1520 concave
1525 Chimney
1530 cylindrical section
1535 channels
1540 top layer, top cover, top lens
1542 Aperture
1550 Second opening
1555 LCD display, display screen
1560 power button
1565 battery enclosure assembly
1570 Triaxial Magnetoresistive Sensor
1573 Printed Circuit Board
1575 Removable Battery Door Assembly
1600 housing
1610 outer housing section
1615 upper housing section
1619 reference marking
1620 magnet assembly
1625 cylindrical spacer
1630 semicircular magnet, magnet
1635 semicircular magnet, magnet
1640 shield magnet, magnet
1650 York
1655 vertical rib, recess

Claims (3)

An implantable programmable fluid drainage valve having an adjustable valve unit comprising a pair of primary magnetic elements, said pair of primary magnetic elements for programming said implantable programmable fluid drainage valve to a desired valve setting. an implantable programmable fluid drainage valve, wherein
A general electronic toolset for suggesting and adjusting the implantable programmable fluid drainage valve, comprising:
(i) an indicator tool having a magnetic field detection sensor array for detecting said pair of primary magnet elements and (ii) determining the presence or absence of a fixed reference magnet within said implantable programmable fluid drainage valve; and said detection. a circuit for determining the center of the adjustable valve unit based on the combined pair of primary magnet elements, the circuit providing electronic feedback from the universal electronic toolset when the fixed reference magnet is present; The circuit determines the angular orientation of the implantable programmable fluid drainage valve only by manual physical palpation in the absence of the fixed reference magnet. a universal electronic toolset comprising circuitry for generating on a display of the general electronic toolset a step for determining
The circuit is
detecting magnetic field patterns produced by each of the pair of primary magnet elements using the magnetic field detection sensor array;
finding a midpoint between the detected pair of primary magnet elements that indicates the center of the adjustable valve unit;
to determine said center of said adjustable valve unit . 2. The system of claim 1 , wherein the angular orientation is the direction of fluid flow through the implantable programmable fluid drainage valve. When the fixed reference magnet is detected as present, the circuit provides (i) an indication of fluid flow direction through the implantable programmable fluid drainage valve solely by the electronic feedback from the universal electronic toolset. and (ii) the found midpoint between the detected pair of primary magnet elements and (iii) a reference line connecting the detected fixed reference magnet. 2. The system of claim 1 , wherein the angular orientation of is determined.

Images