JP7262875B2 - Implantable Fluid Drainage Valve with Magnetic Resistance Engagement Confirmation - Google Patents

Description

The present invention relates to systems and methods for implantable drainage valves for drainage of bodily fluids (eg, cerebrospinal fluid). Specifically, the system and method of the present invention determine whether mechanical features within the valve to resist changes in performance settings when exposed to a magnetic field are properly engaged. Regarding. For example, magnetic fields generated during magnetic resonance imaging (MRI), or other external magnetic fields generated by common household magnets (eg, refrigerator magnets or electronic notebook covers).

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. 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 having at least one magnet.

Magnetic resonance imaging (MRI) for internal examination of one or more parts, organs, or other parts of the body exposed to strong magnetic fields (typically at magnetic field exposure levels of about 3.0 Tesla) is a medical procedure. However, the presence of magnets within the programmable implantable drainage valve may render such systems susceptible to malfunction or improper operation (e.g., unintended changes in performance settings) when exposed to strong magnetic fields, such as during an MRI procedure. high risk. Similar malfunctions in valve operation occur when exposed to other magnets as well.

To avoid such risks, some conventional programmable implantable valves, if functioning or operating properly, are subject to unintended changes in performance settings when the device is exposed to adverse magnets or external magnets. It is modified to include a locking mechanism, engagement mechanism, or magnetic resistance mechanism that ensures that the occurrence of . However, this magnetic resistance mechanism may fail to perform its intended function if not properly locked or engaged, thereby allowing the programmable implantable valve to make changes in parameter settings without prior warning of such risks. It becomes easier to suffer from the possibility of occurrence. This possibility, albeit a relatively small one, of the magnetic field mechanism becoming disengaged (i.e., not properly seated or locked) causes the implantable fluid drainage valve to experience a loss in valve setting when exposed to an external magnet. Undesirable changes may not always be prevented.

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

Therefore, the intention of the valve is to check whether the magnetic resistance mechanism is properly locked or engaged, and thus prevent changes in programmed valve settings when exposed to adverse magnets or external magnets. It would be desirable to develop systems and methods that achieve the described functionality.

One aspect of the present invention is to verify whether the magnetic resistance mechanism is properly locked or engaged, and thus prevent changes in programmed valve settings when exposed to adverse magnets or external magnets. Systems and methods for achieving the intended function of the valve.

Another aspect of the present invention is a bodily fluid implant wherein the magnetic resistance mechanism has an adjustable valve unit with a rotating arrangement and a pair of primary magnetic elements for programming the adjustable valve unit to a desired valve setting. A method for verifying proper engagement within an implantable programmable fluid drainage system with a drainage valve. Using the toolset, a determination is made whether the magnetic resistance mechanism is properly engaged. An alarm is issued if the magnetic resistance mechanism is properly engaged and/or not properly engaged. According to the present invention, a determination of whether the magnetic resistance mechanism is properly engaged is made by (i) measuring the detected one of the pair of primary magnetic elements relative to the direction of fluid flow through the implantable fluid drainage valve; and/or (ii) the measured separation between the respective centers of the pair of primary magnet elements.

In one particular embodiment of the invention, the implantable fluid drainage valve is aligned with markings on the implantable fluid drainage valve that indicate the direction of fluid flow therethrough and a center point midway between a pair of primary magnet elements. Equipped with a fixed reference magnet. A housing of the rotating arrangement comprises an upper casing having a plurality of downwardly projecting teeth in each of which a pair of primary magnet elements are located, and a lower casing comprising a plurality of corresponding setting pockets for receiving the downwardly projecting teeth. . Each setting pocket is constrained on at least one side by a lock stop projecting upwardly from the lower casing toward the upper casing. In this particular aspect of the invention, the determination of whether the magnetic resistance mechanism is properly engaged is determined by measuring the detected one of the pair of primary magnetic elements relative to the direction of fluid flow through the implantable fluid drainage valve. based on angular position. Such determination includes detecting magnetic field patterns produced by each of (i) a fixed reference magnet and (ii) a pair of primary magnet elements using a sensor array within the toolset. A center point midway between the detected pair of primary magnet elements is then located. The flow direction line comprises (i) an arrow indicating the direction of fluid flow through the implantable fluid drainage valve, (ii) a located center point intermediate between a pair of sensed primary magnet elements, and ( iii) defined as a reference line intersecting the detected fixed reference magnet; A rotating component vector is then defined that connects the centers of the detected pair of primary magnet elements. Rotating entity angles are measured starting from the defined stream direction line and moving counterclockwise or clockwise until they intersect the rotating entity vector. Finally, the measured rotating structure angles are compared against predetermined mechanical angular spacings for each of the set pockets as stored in the memory device. If the measured rotating component angle matches any predetermined mechanical angular spacing of the set pockets, the magnetic resistance mechanism is considered properly engaged. In contrast, if the measured rotating component angle does not match the predetermined mechanical angular spacing of any of the set pockets, the magnetic resistance mechanism is considered not properly engaged. That is, the magnetic resistance mechanism is engaged if the plurality of downwardly projecting teeth are properly seated in the corresponding set pockets, but the magnetic resistance mechanism is such that any one of the plurality of downwardly projecting teeth is the locking stopper. not properly engaged when resting on one of the The determining steps described above may be performed after programming the valve settings of the implantable fluid drainage valve and/or prior to the magnetic resonance imaging procedure.

In yet another particular aspect of the invention, an implantable fluid drainage valve comprises a rotating arrangement mounted for rotation within a housing about an axis, a substantially cylindrical central portion extending on the axis. fixedly attached to the This rotating arrangement comprises lateral branches on either side of the axis of the mobile part each housing a respective one of a pair of primary magnet elements having opposite magnetic poles on opposite sides. Mating leads in the elements extend respectively from each of the moving parts. The movable portion is adapted to actuate mating leads within the elements within a series of circularly aligned pockets defined radially inwardly along the outer perimeter of the substantially cylindrical central portion. , is linearly displaceable within the rotating arrangement substantially radially of the movable part. In this configuration, the magnetic resistance mechanism is engaged when the mating lead in the element is placed in one of the pockets, but the magnetic resistance mechanism When resting along the outer perimeter of the substantially cylindrical central portion between adjacent pockets, they are not engaged. Further, in this configuration, as described above, the determination of whether the magnetic resistance mechanism is properly engaged depends on the detected one of the pair of primary magnetic elements relative to the direction of fluid flow through the implantable fluid drainage valve. Based on measured angular position. Alternatively, in this configuration, the determination of whether the magnetic resistance mechanism is properly engaged is based on the measured separation between the respective centers of the pair of primary magnet elements. This is accomplished by detecting the center of each of the pair of primary magnet elements. The separation between the detected centers of each of the pair of primary magnets is then calculated. The calculated separation distance is compared against a predetermined locking value. If the calculated separation equals the predetermined locking value, the magnetic resistance mechanism is considered properly engaged. Conversely, if the calculated separation is greater than the predetermined locking value, the magnetic resistance mechanism is considered not properly engaged.

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.

1 is a schematic exploded perspective view of a programmable valve device having an adjustable valve unit; FIG. 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 taken generally 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; Figure 10 is a top plan view of the elements of Figure 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. 11 is a perspective view of an alternative construction of the lower casing of the adjustable valve unit; FIG. 17B is a perspective view of an alternative configuration of the lower casing of FIG. 17A with the rotating arrangement stacked therein; FIG. 3 shows an alternative configuration of a prior art programmable valve; Figure 18B shows a prior art setting device for use with the programmable valve of Figure 18A;

FIG. 1 shows a prior art programmable shunt valve device 10 having a shunt housing 12 preferably formed from a translucent material such as silicone along with a proximal connector 14 and a distal connector 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 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 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.

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 adjuster tool is applied, as described in more detail below. 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 valve unit and against magnetic or ferromagnetic objects, such as magnets in the indicator tool, as described in more detail below. A coil spring with sufficient biasing force to resist. 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 on bearings 139 formed from a low-friction, 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 may be disc-shaped, conical, or other types of plugs. Spherical balls are currently preferred. 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.

Valve unit 100 is shown assembled in FIGS. 3-5 and positioned at a second pressure setting as described in more detail below. Rotor housing 124 carries downwardly projecting teeth 160 and 162 that cooperate with four locking stops that project 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 of rotor teeth 160 and 162 are circular, and the upper surfaces of casing lock stops 170, 172, 174, and 176, respectively, are adapted to allow the rotor teeth to move into the restrained position, as shown in the side view of FIG. 4A. It has a plurality of facets to form a chisel-like lead-in shape to facilitate recoil. However, the vertical surfaces of teeth 160, 162 and stops 170-176 abut when engaged and do not "draw out", ie, prevent relative translational movement, again as shown in FIG. 4A. Pure vertical lift to overcome tooth-stop abutment and change performance settings must be achieved 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.

Operation of valve unit 100 is illustrated in FIGS. Like reference numerals indicate 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 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 magnet using the adjustment tool, the rotor tooth 162 is pulled up such that subsequent clockwise or counterclockwise rotation of the adjustment tool causes the tooth 162 to move upward. Rotate 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 lock stops 172 and 174 (see FIG. 6B) in a restrained condition, which is a point on the cam structure of rotor 120. Sufficient to prevent rotor 120 from rotating relative to cam follower 132 beyond 192 and point 194 is shown as not 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 .

In FIGS. 6E-6G, the fifth to seventh pressure settings when the rotor tooth 160 is continuously trapped between each of the casing lock stop pairs 170-172, 172-174, and 174-176. pressure settings 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 location of components and features within the valve unit 100 at the first pressure setting shown in FIG. 6A is 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 integral with cam portion 122 . 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 valve setting changes in the presence of an external magnet. The rotor tooth-lock stop abutment mechanically prevents rotational movement from a given performance setting, as these vertical surfaces do not provide an introduction to encourage upward movement on the casing stop. 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 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; Only when properly locked, engaged, or seated within 171'', 171''', the programmable implantable fluid drainage valve resists magnetic fields from external magnets. This device has been tested to be 100% resistant to changes in valve setting for magnetic fields of at least up to about 3T, as long as the magnetic field resistance mechanism is properly engaged. Figures 6A-6H show proper engagement of the magnetic resistance mechanism for each of the eight valve settings. During programming or adjustment of the valve, the downwardly protruding teeth 160, 162 when lowered in the vertical direction undesirably rest on top of one of the lock stops 170, 172, 174, 176 Possibilities exist mechanically. FIG. 8 shows just such an example with tooth 162 resting on top of lock stop 172 . One of the teeth 160, 162 rests on top of the lock stops 170, 172, 174, 176 (i.e., suitably rests or engages within each set pocket defined between adjacent lock stops). If not, the programmable implantable fluid drainage valve is at risk of potentially undergoing undesirable changes in valve settings when exposed to magnets. Heretofore, conventional programming valves have been unable to determine whether the magnetic field mechanism is properly locked or engaged, i.e. the teeth 160, 162 are properly within the set pockets 171, 171', 171'', 171'''. It cannot be confirmed whether or not it will be placed. Therefore, it is uncertain whether the valve will resist possible changes in setting when exposed to a magnetic field. To ensure, after exposure to an external magnet (e.g., after undergoing an MRI procedure), programmed valve settings are reconfirmed by medical personnel using the indicator tool in the associated toolset. It must be. Even though the chances of the teeth not seating properly are relatively small, the chances of the valve setting changing upon exposure of the valve to an external magnet are still of particular concern. This is because the implantable programmable fluid drainage valve cannot be guaranteed to have resistance to magnetic fields within a given range (up to about 3T).

The improved implantable valve drainage system of the present invention provides that downwardly protruding teeth 160, 162 are positioned in respective mounting pockets 171, 171', 171'', 171'' after programming the valve settings or prior to exposure to an external magnet. Essentially, the magnetic resistance mechanism is properly locked to ensure that changes in valve setting are suppressed when the valve is exposed to external magnets. or to eliminate this uncertainty by confirming whether or not it is engaged.

As discussed above, the programmable valve 10 includes 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 FIG. 6I. Prepare. As an example, referring to FIG. 6J, a fixed reference magnet 800 is located in the flow direction of the valve between the proximal connector 14 and the sampling/pumping chamber 18 in the valve. However, this position of fixed reference magnet 800 within the valve may be varied as desired. Additionally, instead of being disposed within the implantable valve itself, the fixed reference magnet 800 can be located on a card placed externally over the valve/patient tissue to assist electronic tools. . Preferably, the fixed reference magnet 800 has a different magnetic strength (nominal 2.7× ¹⁰⁻⁹ Weaver meters) than the primary magnet elements (nominal 3.2× ¹⁰⁻⁹ Weaver meters) 123, 125 and suitable discrimination by the sensor array. (ie, the distance between the reference magnet 800 and the primary magnet 123 as compared to the distance between the primary magnet elements 123, 125). 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 approximately 17.5 mm from the rotating structure 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 valve 10 itself indicating the direction of fluid flow therethrough, and a center point “C” halfway between the 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. The locator tool and indicator tool described herein and shown in the accompanying drawings are integrated into a single device for simplicity of operation, although they could be two separate devices. Please note. However, it is contemplated and within the intended scope of the invention that some, none, or all of the tools within the toolset are integrated. Additionally, the toolset includes an adjustment tool 1415, a screwdriver 1410, and a spare battery 1408.

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.

FIG. 15 is an exploded perspective view of the integrated locator/indicator tool 1405 of FIG. 14 with housing. In the illustrated example, the housing comprises 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 1515 has a chimney 1525 that is complementary in size and shape to be received within passageway or channel 1535 of cylindrical section 1530 of intermediate 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 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 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 or indicators (eg, 1, 2, 3, 5, 6, 7, 8) representing individual valve settings in predetermined increments. 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 which comprises a tray with conventional 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 a circuit board senses the magnetic field pattern produced by each of the magnet elements 123, 125 disposed within the housing 124 of the rotor 120 and the fixed reference magnet 800. Detect separately. 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 carries the processor/controller, memory devices and other electronic circuitry.

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 the magnet assembly 1620, two semi-circular magnets 1630, 1635 are mounted with their flat sides flush with the shield magnet 1640 as shown in FIGS. 16, 16A, 16B and 16D. is rotated to Preferably, the orientation of magnets 1640, 1630, 1635 is such that the magnetic north side of shield magnet 1640 is in contact with semi-circular magnets 1630, 1635, with magnetic north pointing to the bottom of outer housing section 1610. should. 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 as to be received within respective recesses defined in the surfaces. 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 each of the magnet elements 123, 125 disposed within the housing 124 of the rotor 120 and the fixed reference magnet 800 is detected by the two-dimensional array of 3-axis magnetoresistive sensors 1570 of the integrated locator/indicator tool 1405. detected. Once these three magnets are detected, the center point "C" midway between the two detected magnet elements 123, 125 is located (FIG. 6J). A flow direction line "DOF" (or reference line) is identified as passing through the detected fixed reference magnet 800, an arrow or marking "A" indicates the direction of flow on the implantable valve, and a center point "C ' is located halfway between the two detected magnet elements 123,125. A rotation vector “RV” is defined as connecting the two detected magnet elements 123,125. A rotating feature angle α is then measured between the flow direction line "DOF" and the rotation vector "RV". Specifically, the rotating structure angle α is measured starting from the flow direction line “DOF” (as a starting point reference line) and moving counterclockwise until it intersects the rotation vector “RV”.

Once the rotating component angle α is ascertained based on the three sensed magnets within the adjustable valve unit, the valve is adjusted to each setting for that particular implantable valve as described in further detail below. It is compared against the stored predetermined mechanical angular spacing value of the pocket. If this measured rotating component angle α matches the predetermined mechanical angular spacing of any set pocket, the magnetic resistance mechanism is considered properly locked or engaged. In contrast, if the measured rotating component angle α does not match the predetermined mechanical angular spacing of either set pocket, the reluctance mechanism is found not to be properly locked or engaged. A visual indication (eg, text and/or icon) is generated on the display 1555 of the integrated locator/indicator tool 1405 to find that the magnetic resistance mechanism is properly engaged and/or not properly engaged You can make sure that In addition to such visual display indicators, tactile indicators may be provided. If the magnetic resistance mechanism is not properly engaged, instructions and steps to take to reprogram the valve settings using the adjustment tool 1415 and then reconfirm whether the magnetic resistance mechanism is properly engaged. may be displayed on display 1550 of integrated locator/indicator tool 1405 .

Preferably, each time the valve settings are programmed using the adjustment tool 1415, thereafter the integrated locator/indicator tool 1405 according to the present invention verifies whether the magnetic resistance mechanism is properly locked or engaged. used to Alternatively, the integrated locator/indicator tool 1405 of the present invention is used to confirm proper engagement of the magnetic resistance mechanism prior to intentional exposure to an external magnet, such as prior to an (MRI) procedure. good too.

As noted above, based on this particular design of the valve, a predetermined mechanical angular spacing relative to the shunt valve flow direction (as identified by arrow marking "A") is provided for each set pocket 171, 171', 171'. ', 171'''. Each setting pocket 171, 171', 171'', 171''' is constrained on at least one side by a locking stop. Based on this valve configuration, in some designs, such as the Strata® programmable valve, each set pocket is constrained on both sides by adjacent lock stops. That is, each lock stop has a clockwise leading edge and a counterclockwise leading edge. Each setting pocket is therefore defined on one side by the counterclockwise leading edge of the first locking stop and on the other side by the clockwise leading edge of the second locking stop adjacent to the first locking stop. be restrained. In either case, whether the set pockets are constrained by one or two locking stops, the mechanical angular spacing or angular width of each set pocket for a given programmable valve is determined by a fixed reference magnet may be dynamically adjusted based on skin depth, as it has been found that can affect the identification of the set pocket, which varies slightly the further away from the valve. The distance between rotating arrangement magnets can be used to determine depth. The mechanical angular spacing or width is therefore controlled by the valve design. The sensor array does not identify pockets, but magnetics are not quite as simple as just magnetic field measurements. Characterization has shown that the magnetic field varies based on the distance away from the integrated locator/indicator tool's sensor array. Therefore, the actual boundaries of the set pocket change based on the distance from the sensor array. This has been confirmed by testing multiple valves at extremes of set pocket location and distance from the locator/indicator tool. An algorithm determines the distance based on pre-measured valves and calculates where the boundary should be. The predetermined mechanical angular spacing of each set pocket is represented by two mechanical angular boundary values that define opposite sides of the set pocket. The first mechanical angle boundary value represents the mechanical angle of the leading edge of each lock stop starting with the flow direction as a reference and moving in a counterclockwise direction, while the second mechanical angle boundary measurement represents the set pocket represents the mechanical angle when a constant angular width of is added to the first mechanical angle boundary measurement in the clockwise direction. The first mechanical angle boundary value and the second mechanical angle boundary value represent the predetermined mechanical angular spacing for that particular set pocket. A first mechanical angle boundary value and a second mechanical angle boundary value for each set pocket of a particular programmable valve are pre-identified and stored in memory, eg, in a locator/indicator tool.

6A-6H are exemplary diagrams of eight different pressure settings and their associated setting pockets for the CODMAN CERTAS® Plus Programmable Valve, some of which have adjacent lock stoppers. (eg 170-172, 172-174, 174-176) while other setting pockets are only constrained by a single locking stop (eg 176). The mechanical angular spacing of each set pocket for the CODMAN CERTAS® Plus Programmable Valve configuration is shown in Table 1 below.

17A and 17B, the lower casing 1700 and rotating arrangement 1705 of the Strata® Programmable Valve have a different configuration than that of the CODMAN CERTAS® Plus Programmable Valve. Specifically, five setting pockets 1710, 1712, 1714, 1716, 1718 are disposed within the lower casing 1700 in a 360 degree circular configuration, each setting pocket having an adjacent locking stopper 1720, 1722, 1724, 1726. , 1728. That is, each of the five setting pockets 1710, 1712, 1714, 1716, 1718 is positioned by the clockwise leading edge of the first locking stop on one side and adjacent the first locking stop on the other side. defined by the counterclockwise leading edges of the two lock stops. Each of the five setting pockets thus has a constant angular width or mechanical angular spacing.

The safety features of the present invention are also applicable to other constructs where the magnetic resistance mechanism, when properly engaged or locked, rests within a corresponding cavity/pocket/recess. It has one or more structural components placed One or more downwardly projecting teeth are received within respective set pockets defined by one or more locking stops (as described above) instead, as shown in FIGS. 18A and 18B. No. 5,643,194 (herein incorporated by reference in its entirety) discloses one alternative wherein cylindrically-shaped mating leads in an element or component are received within respective complementary-shaped cavities, notches, openings, or pockets. A design is described.

The plan view of FIG. 18A shows the valve body 1 without the upper cover and the casing 3. FIG. A cavity 4, indicated by dashed lines in FIGS. 18A and 18B, is formed at the periphery of the substantially cylindrical central portion 2a. The valve body 1 comprises a cylindrical and flat inner chamber 5 formed between the lower wall 3b, the side walls 3a of the casing 3 and the upper cover 2. As shown in FIG. An inlet pipe 6 and a drain pipe 7 are formed in the lateral wall 3 a of the casing 3 , the inner ends of said pipes 6 and 7 being arranged diagonally within the chamber 5 . An inlet pipe 6 and a drain pipe 7 are connected to a catheter for supplying fluid and another catheter for draining fluid, respectively.

A rotating arrangement or rotor 8 comprising an H-bar is rotatably mounted within the chamber 5 about a central axis 9 . A stop element 21 projecting from the lower wall 3b of the casing 3 is provided for limiting the rotational displacement of the rotor 8. As shown in FIG. The rotor 8 serves as guide means for the moving parts 10 and 11, accommodating the micromagnets 12 and 13, respectively, in a state in which the opposing surfaces of the micromagnets 12 and 13 have opposite magnetic poles (N and S). On both sides of the central axis 9 are provided lateral branches 8a that serve. The mobile parts 10 and 11 are linearly displaced inside the rotor 8 substantially in their radial direction to activate the locking mechanism. In particular, the locking mechanism is provided outwardly of the substantially cylindrical central portion 2a for receiving complementary shaped mating leads in elements 10a and 11a (e.g. cylindrical lugs) projecting from the movable portions 10 and 11, respectively. It comprises a circular array of a series of open mating pockets, notches or cavities 4 defined radially inwardly along the sides. Between adjacent open cutouts or cavities 4 are located portions of the substantially cylindrical central portion 21, hereinafter referred to as partition posts.

The valve body 1 comprises a check valve consisting of a ball 14 and a conical seat 15 arranged at the inner end of the inlet pipe 6 . A semi-circular leaf spring 16 is fixed against one lateral branch 8a of the rotor 8, parallel to the lateral wall 3a of the chamber 5, and presses the ball 14 into the seat 15 to open the inlet pipe. regulating and, where appropriate, blocking passage of fluid into chamber 5 via 6; As in the valve design of FIG. 1, the alternative valve design of FIG. 18A may also include a fixed reference magnet 800. FIG.

Figure 18B represents a prior art external setting device 17 placed on the valve body 1 of Figure 18A. The external setting device 17 comprises two magnets 18 and 19, for example made of samarium-cobalt, the facing faces of which are of opposite magnetic poles (N and S) and are associated with the valve body 1. of magnetic mass greater than the movable micro-magnets 12 and 13. The magnets 18 and 19 are mounted on a common annular support 20, for example made of soft iron, and are positioned outside the two mobile micro-magnets 12 and 13 when the lugs 10a and 11a are engaged in the notches or cavities 4. Diagonally opposed and separated by a distance substantially equal to or greater than the distance separating the square poles.

Next, the operation of the external setting device 17 in FIG. 18B will be described. Figure 18A represents the valve body 1 in the locked position, i.e. the cylindrical lugs 10a, 11a are both engaged in their respective notches or cavities 4 and the magnetic poles of the micro-magnets 12, 13 are opposite to the magnetic field. It is locked in place therein as a result of the attraction.

18B depicts the valve body 1 in the unlocked position, with both cylindrical lugs 10a, 11a disengaged from the notches or cavities 4. FIG. To unlock the valve (disengage or remove the cylindrical lugs 10a, 11a from their respective notches or cavities 4), an external setting device 17, shown in FIG. Magnets 18 , 19 having opposite magnetic poles (N and S) on their facing surfaces are positioned on either side of the micromagnets 12 , 13 axisymmetrically with respect to the central axis 9 of the chamber 5 . Naturally, the strength of the magnets 18,19 must be higher than the strength of the micromagnets 12,13 in order to overcome the attractive forces that exist between the micromagnets 12,13.

Bearing in mind the difference in magnetic mass that exists between the magnets 18, 19 of the external setting device 17 and the micromagnets 12, 13 of the valve, simply place the magnets of the setting device near the opposite south and north poles of the micromagnets. By arranging the north and south poles, the two outer magnetic poles of the micromagnets 12, 13 are exposed to a higher perimeter attractive force than the central mutual attractive force between the two inner magnetic poles. This results in the two micro-magnets 12, 13 with their mobile parts 10, 11 separating symmetrically and simultaneously towards the outer edge of the chamber 5, whereby the rotor 8 is unlocked or disengaged. and free rotation is possible. This unlocking or disengagement of the rotor 8 changes the position of the rotor 8 by pivoting the setting device 17 about the central axis of the chamber of the valve thereby simultaneously driving the rotor. , resulting in the ability to vary the operating pressure and throughput of the valve. In order to lock the rotor 8 in the new desired position, the setting device 17 is pulled and moved away perpendicularly to the plane of the valve. Since the two micro-magnets 12, 13 are no longer subject to the external perimeter attraction by the magnets 18, 19, the micro-magnets 12, 13 will again approach each other under the influence of their mutual attraction and thus their respective notches. or placing (ie locking) the lugs 10a, 11a in the cavity 4;

This type of valve with movable micro-magnets is resistant to the presence of strong external magnetic or electromagnetic fields, since the two movable micro-magnets 12, 13 cannot be disengaged from their cavities simultaneously in the presence of a unidirectional magnetic field. Underneath to achieve magnetic field resistance to changes in valve settings. As long as the two movable micro-magnets 12 and 13 are placed on either side of the central axis of the valve, when one of the micro-magnets is pulled towards the perimeter of the chamber, the other is pushed back into the locking cavity. be An external setting device as shown in FIG. 18B is required for unlocking or disengaging the valve, ie for symmetrically spacing the micromagnets 12, 13 apart.

However, the valves described above, shown in FIGS. 18A and 18B, are exposed to external magnets only if the cylindrical lugs 10a, 11a are properly seated, engaged or locked within their respective notches or cavities 4. does not suffer changes in valve settings. Similar to what was discussed above in relation to the CODMAN CERTAS® Plus Programmable Valve, when unlocked the lugs 10a, 11a are appropriately seated or engaged within their respective notches or cavities 4. Instead, the regions of the outer perimeter of the substantially cylindrical central part 2a between adjacent notches or cavities 4, hereinafter referred to as partition posts area along the edge).

According to the invention, whether the valve in FIG. ) exist in two different ways. If the valve in FIG. 18B comprises a fixed reference magnet 800, one method by which proper engagement may be verified is based on the detected angular position of the micro-magnet 12 (see above using integrated locator/indicator tool 1405). (by the method detailed in ). Once the angular position of the micro-magnets 12 has been determined, this angular position is compared against the predetermined angular spacing of each notch or cavity 4 . If the detected angular positions of the micromagnets 12 match the predetermined angular spacing of one of the respective notches or cavities 4, the valve is considered properly locked (i.e. the lugs 10a, 11a are suitably engaged or seated in the respective notches or cavities 4). In contrast, if the detected angular positions of the micromagnets 12 do not match the predetermined angular spacing of either the respective notches or cavities 4, the valve is not properly locked (i.e. lugs 10a, 11a rests on the compartment post). In such latter case, the user is again instructed to adjust the valve using the external setting device 17 and then to see if the valve is properly engaged, seated or locked. be done.

An alternative method for checking whether the valve of FIG. 18B is locked or properly engaged is based on the measured distance between the centers of the two micro-magnets 12,13. As discussed in detail above, withdrawing the external setting device 17 from the valve causes the micromagnets 12, 13 to pull toward each other to hold them in place. When the micro-magnets 12, 13 are properly seated, engaged or locked within their respective notches or cavities 4, the spacing distance between the centers of the micro-magnets 12, 13 is a predetermined suitable locking value. In contrast, the micromagnets 12, 13 are instead mounted along the outer perimeter of the substantially cylindrical central portion 2a between two adjacent notches or cavities 4 (i.e. on compartment posts). If positioned, the centers of each micromagnet 12, 13 will have a separation distance from each other that is greater than the predetermined locking value. Therefore, this alternative method can also use the same integrated locator/indicator tool 1405 to detect the center of each micro-magnet 12, 13 on the rotating arrangement and measure the distance between them. , and then a comparison with a predetermined locking value is made. Of course, the algorithm of the integrated locator/indicator tool 1405 would have to be modified for this alternative method. The valve is properly engaged or locked (i.e. the lugs 10a, 11a are properly positioned within their respective notches or cavities 4) if the measured distance is equal to a predetermined locking value that indicates proper locking. but if the measured distance is greater than the predetermined locking value, then the valve is improperly engaged or not locked (i.e. lugs 10a, 11a are placed on top). As with other embodiments, the user is instructed to reprogram the valve to the desired settings and double check that the valve is properly locked or engaged.

The improved toolset of the present invention using sensor arrays for use with programmable valves provides an additional safety feature to confirm whether the valve's magnetic resistance feature is properly engaged. This additional safety feature can be triggered each time the valve is programmed to a new setting or prior to exposure to an external magnet, such as prior to an MRI procedure. A tool set of the present invention with this additional safety feature, when locked in place, allows structural components to rest or engage within corresponding notches, recesses, cavities, pockets, or other complementary shaped areas. suitable for use with any type of programmable valve.

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.

1 valve body
2 upper cover
2a central part
3 casing
3a side wall
3b lower wall
4 cavities
5 flat inner chamber
6 inlet pipe
7 drain pipe
8 rotor
8a lateral branch
9 central axis
10 programmable shunt valve device, programmable valve, programmable shunt valve, moving parts
10a cylindrical lug, element
11 Moving parts
12 Movable micro magnets, micro magnets, shunt housings, housings
13 Movable micro magnets, micro magnets
14 proximal connector, ball
15 Conical seat, seat
16 semi-circular leaf spring
16 Distal connector
17 External configuration device
18 sampling/pumping chamber, magnet, sampling chamber or pumping chamber
19 Magnet
20 Common annular support, needle guard
21 central part, stop element
22 backing plate
30 Passage
100 adjustable valve unit, valve unit
100 valve unit
102 Entrance
103 Casing
104 upper casing
106 lower casing
120 Rotor, rotating structure
122 lower cam structure, lower cam section, cam portion
123 primary magnet element, primary magnet
124 upper magnet housing, housing, rotor housing, housing part
125 primary magnetic elements, primary magnets, magnets
126 rotor axle, axle
127 fingers
129 Tantalum Ball, Tantalum Reference Ball
130 spring arm unit
132 rigid cam followers, cam followers
133 stiffening elements
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 tooth, rotor tooth, tooth
162 downward protruding tooth, rotor tooth, tooth, rotor housing tooth
170 Casing lock stopper, lock stopper, casing stopper,
171 setting pocket, loading pocket
171' setting pocket, placement pocket
171'' setting pocket, placement pocket
171''' setting pocket, placement pocket
172 Casing lock stopper, lock stopper
174 Casing lock stopper
176 Casing lock stopper
180 Limiter
182 Gasket
190 locations
191 first cam surface
192 locations
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
1410 screwdriver
1415 Adjustment Tool
1420 Cavity
1505 lower housing section, lower housing
1510 intermediate housing section
1515 upper housing section
1520 concave
1525 Chimney
1530 cylindrical section
1535 channels
1540 top layer, top cover
1542 Aperture
1550 2nd opening, display
1555 display
1560 buttons
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
1620 magnet assembly
1625 cylindrical spacer
1630 semicircular magnet, magnet
1635 semicircular magnet, magnet
1640 shield magnet, magnet
1650 York
1655 vertical rib
1620 magnet assembly
1630 semicircular magnet, magnet
1635 semicircular magnet, magnet
1640 shield magnet, magnet
1700 lower casing
1705 rotating construct
1710 setting pocket
1712 setting pocket
1714 setting pocket
1716 setting pocket
1718 setting pocket
1720 lock stopper
1722 lock stopper
1724 lock stopper
1726 lock stopper
1728 lock stopper

Claims (14)

An implantable programmable magnetic resistance mechanism comprising an implantable fluid drainage valve having an adjustable valve unit comprising a rotating arrangement and a pair of primary magnetic elements for programming said adjustable valve unit to a desired valve setting. A method for verifying proper functioning in a bodily fluid drainage system comprising:
a locator tool determining whether the magnetic resistance mechanism is functioning properly;
and an indicator providing a warning when the magnetic resistance mechanism is at least one of functioning properly or not functioning properly. The step of determining whether the magnetic resistance mechanism is functioning properly comprises: (i) moving the sensed primary of the pair of primary magnetic elements relative to the direction of fluid flow through the implantable fluid drainage valve; 2. The method of claim 1, based on the measured angular positions of the magnet elements and/or (ii) the measured separation between respective centers of the pair of primary magnet elements. the determining step based on the measured angular position of the detected one of the pair of primary magnetic elements relative to the direction of fluid flow through the implantable fluid drainage valve; 3. The method of claim 2, wherein determining whether the magnetic resistance mechanism functions properly. the implantable fluid drainage valve comprising a fixed reference magnet aligned with markings on the implantable fluid drainage valve indicating a direction of fluid flow therethrough and a center point midway between the pair of primary magnet elements ; The rotating arrangement comprises a housing having a plurality of downwardly projecting teeth in which the pair of primary magnet elements are located and the adjustable valve unit receives an upper casing and the downwardly projecting teeth. each of said setting pockets bounded on at least one side by a locking stop projecting upwardly from said lower casing towards said upper casing; ,
The step of determining
(i) detecting magnetic field patterns produced by each of the fixed reference magnet and (ii) the pair of primary magnet elements using a sensor array in the locator tool ;
locating the center point midway between the detected pair of primary magnet elements;
(i) an arrow indicating the direction of fluid flow through the implantable fluid drainage valve; (ii) the located center point intermediate between the detected pair of primary magnetic elements; and (iii) defining a flow direction line as a reference line connecting the detected fixed reference magnet;
defining a rotational entity vector connecting the centers of the detected pair of primary magnet elements;
measuring the rotational entity angle starting from the defined flow direction line in a counterclockwise or clockwise direction until the rotational entity vector is reached;
comparing the measured rotating structure angles to a predetermined mechanical angular spacing for each of the set pockets as stored in a memory device, wherein the measured rotating structure angles correspond to the setting The magnetic resistance mechanism is considered to be functioning properly if the predetermined mechanical angular spacing of any of the pockets is met; 4. The method of claim 3, wherein the magnetic resistance mechanism is deemed to be malfunctioning if any of the predetermined mechanical angular spacings are not met. 5. The method of claim 4, wherein the fixed reference magnet is disposed between a proximal connector of the implantable fluid drainage valve and a pump chamber. 5. The method of claim 4, wherein the plurality of locking stops and the corresponding setting pockets are equal in number. 2. The method of claim 1, wherein the step of determining is performed after programming valve settings for the implantable fluid drainage valve. 2. The method of claim 1, wherein the step of determining is performed prior to a magnetic resonance imaging procedure. 2. The method of claim 1, wherein issuing a warning comprises generating visual and/or tactile cues. The magnetic resistance mechanism functions when the plurality of downwardly projecting teeth are properly seated within the corresponding setting pockets, but the magnetic resistance mechanism is dependent on whether any of the plurality of downwardly projecting teeth is positioned in the lock. 5. The method of claim 4, which does not function properly when resting on one of the stoppers. The rotating arrangement is rotatably mounted within the housing about an axis with a substantially cylindrical central portion fixedly mounted on the axis, the rotating arrangement having opposing surfaces with with lateral branches on either side of the axis of the moving part each housing a respective one of said pair of primary magnet elements having opposite polarities, with mating leads in the elements extending respectively from each of said moving parts. and said movable portion extends said mating lead within an element within a series of circularly aligned pockets defined radially inwardly along the outer perimeter of said substantially cylindrical central portion. 3. The method of claim 2, wherein the movable portion is linearly displaceable within the rotating arrangement substantially radially to actuate the . The magnetic resistance mechanism functions when the mating leads in the elements are placed in one of the pockets, but the magnetic resistance mechanism does not allow the mating leads in the elements to reciprocate. 12. The method of claim 11, wherein the method is non-functional when placed along the outer perimeter of the substantially cylindrical central portion between adjacent pockets. The step of determining
determining an angular position of one of said pair of primary magnet elements and comparing said detected angular position to a predetermined angular spacing of said respective pockets, said detected angular position The magnetic resistance mechanism is considered to be functioning properly if the positions match one of the predetermined angular intervals within the respective pockets, in contrast the detected angular 12. The magnetic resistance mechanism of claim 11, comprising the step of deeming that the magnetic resistance mechanism is not functioning properly if a position does not meet the predetermined angular spacing of any of the respective pockets. Method. The step of determining
detecting the center of each of said pair of primary magnet elements;
calculating a separation between the detected centers of each of the pair of primary magnets;
comparing the calculated separation distance to a predetermined locking value, wherein if the calculated separation distance is equal to the predetermined locking value, the magnetic resistance mechanism is functioning properly. and, by contrast, if the calculated separation distance is greater than the predetermined locking value, then the magnetic resistance mechanism is deemed not functioning properly. The method described in 11.

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