JP2020054729A - Implantable bodily fluid drainage valve with magnetic field resistance engagement confirmation - Google Patents

Abstract

To provide a method for verifying whether or not a magnetic field resistance mechanism is properly engaged in a drainage valve having an adjustable valve unit including a rotating construct and a pair of primary magnetic elements for programming the valve unit.SOLUTION: Using a tool set, a determination is made whether or not the magnetic field resistance mechanism is properly engaged. An alert is generated whether the magnetic field resistance mechanism is at least one of properly engaged or not properly engaged based on: a measured angular position of a detected one of the pair of primary magnetic elements 123, 125 relative to a direction of flow of fluid through the valve; and/or (ii) a measured distance separation between respective centers of the pair of primary magnetic elements.SELECTED DRAWING: Figure 6J

Description

  The present invention relates to systems and methods for an implantable drainage valve for draining bodily fluids (eg, cerebrospinal fluid). In particular, the systems and methods of the present invention determine whether mechanical features in a valve to prevent changes in performance settings when exposed to a magnetic field are properly engaged. About. For example, a magnetic field generated while undergoing a magnetic resonance imaging (MRI) or other external magnetic field generated by a common household magnet (eg, a refrigerator magnet or an electronic notebook cover).

  Hydrocephalus is the retention of cerebrospinal fluid in the brain as a result of increased output, or more commonly, obstruction or reduced absorption of fluid pathways. Cerebrospinal fluid (CSF) shunts have been used for decades to treat hydrocephalus. CSF shunting involves establishing a secondary pathway for CSF transit to bypass the occlusion of the natural pathway.

  This short path is positioned to allow drainage of CSF from the ventricle or subarachnoid space into another absorption site (eg, the right atrium or peritoneal cavity of the heart) via a system of miniature catheters. An adjustment device such as a valve may be inserted into the catheter path. In general, the valve keeps CSF flowing away from the brain and modulates pressure or flow. Drainage systems using catheters and valves can drain excess CSF in the brain, thereby reducing intracranial pressure.

  Some implantable valves are fixed pressure valves (ie, mono-pressure valves) and others have adjustable or programmable settings. Programmable or adjustable implantable valves are desirable in that valve pressure settings can be changed non-invasively through an external control device during treatment without the need for explants. One such conventional adjustable or programmable implantable valve using magnets is assigned to DePuy Orthopedics, a J & J company, related to the present assignee, and is incorporated by reference in U.S. Pat. No. 4,595,390, CODMAN® HAKIM® Programmable Valve (CHPV). Another programmable implantable drainage valve is CODMAN (US Pat.No. 8,322,365), also disclosed in U.S. Pat. (Registered trademark) CERTAS (registered trademark) or CERTAS (registered trademark) Plus Programmable Valve. Medtronic also has a programmable implantable shunt valve Strata® controlled using magnets. The pressure settings in these aforementioned conventional programmable implantable valves can be adjusted non-invasively after implantation into the body using a rotating component or rotor having at least one magnet.

  Magnetic resonance imaging (MRI) is an internal examination of one or more parts, organs, or other parts of the body that have been exposed to a strong magnetic field (typically at a magnetic field exposure level of about 3.0 Tesla). Is a medical procedure. However, due to the presence of magnets in the programmable implantable drainage valve, such systems can fail or become improperly operated (e.g., unintended changes in performance settings) when exposed to strong magnetic fields, e.g., during an MRI procedure. High risk. A similar malfunction in the operation of the valve occurs similarly when exposed to other magnets.

  To avoid such risks, some conventional programmable implantable valves, when functioning or operating properly, have unintended changes in performance settings when the device is exposed to detrimental or external magnets. Has been modified to include a locking mechanism, an engagement mechanism, or a magnetic field resistance mechanism that reliably suppresses the generation of the magnetic field. However, if this field resistance mechanism is not properly locked or engaged, it may not be able to perform its intended function, thereby causing the programmable implantable valve to make changes in parameter settings without prior warning of such risks. More likely to occur. The potential for this field mechanism to become disengaged (i.e., not properly seated or locked), albeit with a relatively small possibility, causes the implantable bodily fluid drainage valve to be in a valve setting when exposed to an external magnet. Undesirable changes may not always be prevented.

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

  Thus, it is to ensure that the field resistance mechanism is properly locked or engaged, and thus to prevent changes in the programmed valve settings when exposed to detrimental magnets or external magnets, and to prevent valve intent. It would be desirable to develop systems and methods that achieve the functions provided.

  One aspect of the present invention determines whether a field resistance mechanism is properly locked or engaged, and thus prevents changes in programmed valve settings when exposed to detrimental or external magnets. Systems and methods that achieve the intended function of a valve.

  Another aspect of the invention is an implantable bodily fluid wherein the magnetic field resistance mechanism comprises an adjustable valve unit with a rotating configuration and a pair of primary magnet elements for programming the adjustable valve unit to a desired valve setting. A method for verifying proper engagement in an implantable programmable bodily fluid drainage system with a drainage valve. Using the toolset, a determination is made whether the field resistance mechanism is properly engaged. An alert is issued if the field resistance mechanism is or is not properly engaged. According to the present invention, the determination of whether the magnetic field resistance mechanism is properly engaged is determined by (i) one of the detected one of the pair of primary magnet elements relative to the direction of fluid flow through the implantable bodily fluid drainage valve. And / or (ii) the measured separation between each center of the pair of primary magnet elements.

  In one particular aspect of the present invention, the implantable bodily fluid drainage valve is aligned with a marking on the implantable bodily fluid drainage valve indicating the direction of fluid flow therethrough and a center point intermediate between the pair of primary magnet elements. It has a fixed reference magnet. The 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 having a plurality of corresponding setting pockets for receiving the downwardly projecting teeth. . Each of the setting pockets is restrained on at least one side by a lock stopper projecting upward from the lower casing towards the upper casing. In this particular aspect of the invention, the determination of whether the magnetic field resistance mechanism is properly engaged is determined by measuring one of the pair of primary magnet elements detected relative to the direction of fluid flow through the implantable bodily fluid drainage valve. Based on the angle position. Such a determination includes using a sensor array in the toolset to detect a magnetic field pattern generated by (i) a fixed reference magnet and (ii) each of a pair of primary magnet elements. Then, an intermediate center point between the detected pair of primary magnet elements is located. A flow direction line comprising: (i) an arrow indicating the direction of fluid flow through the implantable bodily fluid drainage valve; (ii) an intermediate located center point between a pair of detected primary magnet elements; and iii) Defined as a reference line crossing the detected fixed reference magnet. Thereafter, a rotational component vector connecting the centers of the detected pair of primary magnet elements is defined. The angle of the rotating component, starting from the defined flow direction line and moving in a counterclockwise or clockwise direction until it intersects the rotating component vector, is measured. Finally, the measured rotating component angles are compared against a predetermined mechanical angle interval for each of the setting pockets as stored in a memory device. If the measured rotational component angle matches any predetermined mechanical angular spacing of the setting pocket, the field resistance mechanism is considered properly engaged. In contrast, if the measured rotational component angle does not match any predetermined mechanical angular spacing of the setting pocket, the field resistance mechanism is deemed to be not properly engaged. That is, the magnetic field resistance mechanism is engaged when the plurality of downwardly projecting teeth are properly placed in the corresponding setting pockets, but the magnetic field resistance mechanism is such that any of the plurality of downwardly projecting teeth is locked by the lock stopper. Not properly engaged when resting on one of the The foregoing determining step may be performed after programming of the valve settings of the implantable fluid drainage valve and / or before the magnetic resonance imaging procedure.

  In yet another particular aspect of the invention, an implantable bodily fluid drainage valve comprises a rotating structure rotatably mounted about an axis within a housing, wherein the substantially cylindrical central portion has an axial center on the axis. Fixedly attached to The rotating structure comprises side branches on opposite sides of the axis of the movable part, each housing a respective one of a pair of primary magnet elements having oppositely facing magnetic poles. Mating leads in the element each extend from each of the movable parts. The movable portion is configured to actuate mating leads in a series of elements in a series of circular pockets defined radially inward along an outer perimeter of a substantially cylindrical central portion. , Can be linearly displaced within the rotary structure substantially in the radial direction of the movable part. In this configuration, the magnetic field resistance mechanism is engaged when the mating lead in the element is placed in one of the pockets, but the magnetic field resistance mechanism causes the mating lead in the element to If they are placed along the outer perimeter of a substantially cylindrical central portion between adjacent pockets, they will not engage. Further, in this configuration, as described above, the determination of whether the magnetic field resistance mechanism is properly engaged depends on the detected one of the pair of primary magnet elements relative to the direction of fluid flow through the implantable bodily fluid drainage valve. Based on the measured angular position. Alternatively, in this configuration, the determination of whether the field resistance mechanism is properly engaged is based on the measured separation between centers of the pair of primary magnet elements. This is achieved by detecting the center of each of the pair of primary magnet elements. The separation between each detected center of the pair of primary magnets is then calculated. The calculated separation distance is compared against a predetermined locking value. If the calculated separation is equal to the predetermined locking value, the field resistance mechanism is considered properly engaged. In contrast, if the calculated separation is greater than a predetermined locking value, the field resistance mechanism is deemed not to be properly engaged.

  The foregoing and other features of the present invention will become more readily apparent from the following detailed description of embodiments of the invention and the drawings. Like reference numerals designate like elements throughout the several views.

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. FIG. 3 is a top view of the adjustable valve unit of FIG. 2. FIG. 4 is a side sectional view of the adjustable valve unit of FIG. 3 along line 4-4. FIG. 4 is a side view of a single rotor tooth in engagement with a single lock stopper. FIG. 5 is a cross-sectional view of the adjustable valve unit of FIG. 3 along line 5-5. FIG. 7 is a partial cross-sectional view of the adjustable valve unit of FIG. 4 substantially along line 6-6 at a first pressure setting. FIG. 7 is a cross-sectional view of a further depth of the adjustable valve unit of FIG. 4 substantially along line 6A-6A at a 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. 5 is a partial cross-sectional view of the adjustable valve unit of FIG. 4 at an exemplary first pressure setting, showing an arrow marked on the programmable valve device indicating the direction of fluid flow therethrough and a fixed reference magnet. FIG. 6C 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 further illustrating the flow direction marked by arrows and the positioning of the fixed reference magnet. FIG. 7 is a cross-sectional view of a deeper section of the adjustable valve unit of FIG. 4 substantially along line 7-7. FIG. 8 is a cross-sectional view of the adjustable valve unit of FIG. 7, showing a transition to a different pressure setting. FIG. 7 is a perspective view of a spring arm unit having an optional torsion spring. FIG. 10 is a top plan view of the elements of FIG. 9; FIG. 9 is a side cross-sectional view of the adjustable valve unit of FIG. FIG. 6C is a partial top cross-sectional view of the shallower portion of the adjustable valve unit of FIG. 6H showing the “substantially off” position in an unrestrained condition. FIG. 12 is a side view taken along line 12-12 of FIG. FIG. 13 is a side sectional view taken along line 13-13 of FIG. FIG. 14 is a partial cross-sectional view taken along line 13A-13A of FIG. FIG. 2 is a perspective view of a tool set including an integrated locator / indicator tool, an adjustment tool, and a screwdriver. FIG. 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 in the integrated locator / indicator tool. FIG. 15 is an exploded perspective view of the integrated locator / indicator tool of FIG. FIG. 15 is an exploded perspective view of the adjustment tool of FIG. FIG. 17 is a perspective view showing an arrangement of semicircular magnets on both sides of a magnetic shield including a part of the magnet assembly of FIG. 16; FIG. 17 is a perspective view of the assembled magnet assembly of FIG. FIG. 17 is a top view of the assembled lower housing section and intermediate housing section 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. 7 is a perspective view of an alternative configuration 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 components stacked thereon. FIG. 3 illustrates an alternative configuration of a prior art programmable valve. FIG. 18B illustrates a prior art setting device for use with the programmable valve of FIG. 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 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 pumped into the sampling or pump chamber 18 and then passes through a valve mechanism in the inlet 102 and into the adjustable valve unit 100. This is shown and described in further detail below in connection with FIGS. The valve unit 100 (see FIG. 1) comprises a casing 103 formed in this configuration as an upper casing 104 and a lower casing 106 joined by sonic welding. A needle guard 20, preferably formed of a rigid polymer material, and a lower casing 106 are secured within the housing 12 by a backing plate 22, preferably formed of silicone reinforced by a polymer mesh, Bonded to housing 12 by medical epoxy. A fixed reference magnet 800, as described in further detail below, is preferably mounted on a bump or protrusion 801 on the needle guard 20.

  When the fluid pressure at the inlet 102 exceeds the selected pressure setting in the valve unit 100, fluid enters beyond the valve mechanism and then flows through the valve unit outlet 110 into the passage 30 of the housing 12. Eventually, fluid exits housing 12 and passes through distal connector 16 into a peritoneal catheter or other distal catheter.

  The valve unit 100 (see FIG. 2) includes a rotor 120, a spring arm unit 130, a valve mechanism 140, and a rotor holding spring 150. The rotor 120, also referred to as a rotating structure, includes a lower cam structure 122 having a plurality of radially flat cam surfaces, as shown and described in more detail below, and a magnet element 123, which is an N-pole magnet and an S-pole magnet, respectively. And an upper magnet housing 124 carrying 125. Housing 124 also defines fingers 127 that engage a stopper within upper casing 104 when rotor 120 is moved to an unrestrained condition, as described below. The rotor 120 rotates about an axle 126 that defines a substantially fixed rotation axis R at a first position within the casing 103.

  Preferably, the rotor 120 is also capable of moving to an unconstrained condition along the axis of rotation in translation when an adjuster tool is applied, as described in further detail below. The retaining spring 150 biases the rotor 120 down to normal restraint conditions. Preferably, the spring 150 is sufficient to resist gravitational effects regardless of the position of the valve unit and to a magnetic or ferromagnetic object such as a magnet in the indicator tool, as described in further detail below. A coil spring having a sufficient biasing force to resist. However, the spring 150 is insufficient to resist the effects of the adjustment tool described further below. The lower cam section 122 is high enough to ensure that the cam follower 132 remains in contact with the cam surface in both constrained and unconstrained conditions.

  The spring arm unit 130 includes a cam follower 132, an elastic spring element 134, and an upper axle 136 and a lower axle 138 at a second position of the casing 103. The axle 138 pivots about a bearing 139 formed of a low friction, hard material such as synthetic ruby. Desirably, the casing 103, rotor 120, and spring arm unit 130 are formed from polyethersulfone, and all spring components are formed from medical non-ferromagnetic stainless steel.

  The valve mechanism 140 includes a seat 142 and a 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 a disc, conical, or other type of plug. At present, spherical balls are preferred. This is because this configuration allows for tight and accurate tolerances, assembly and control over 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 value achieved at each setting using the force-displacement relationship. First, the mandrel locates the ball and the seat is inserted at the estimated desired position in the port. Ball displacement is tested at one or more settings to ensure that the desired performance is achieved.

  The valve unit 100 is shown in the assembled state in FIGS. 3-5 and is positioned at a second pressure setting as described in further detail below. The rotor housing 124 carries, in this configuration, downwardly projecting teeth 160 and 162 that cooperate with four lock stops that project upwardly from the lower casing 106. Lock stopper 172 is shown in partial cross-section in FIG. 4, and lock stoppers 170 and 176 can be seen in FIG. Preferably, the lower surfaces of the rotor teeth 160 and 162 are circular, and the upper surfaces of the casing lock stops 170, 172, 174, and 176 each bring the rotor teeth into the locked position as shown in the side view of FIG.4A. And a plurality of facets to form a chisel-like introduction shape that facilitates return. However, the vertical surfaces of the teeth 160, 162 and the stops 170-176 abut when engaged and do not "pull out", ie, prevent relative translation as also shown in FIG. 4A. Pure vertical elevation to overcome tooth-stop abutment and change performance settings must be achieved by an adjustment tool, as described in further detail below.

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

  The operation of the valve unit 100 is shown in FIGS. Like reference numerals indicate equivalent components and features. Not all such components and features are marked on each figure for visual clarity. 6 and 6A are upper partial cross-sectional views at different heights of the valve unit 100 at the first pressure setting. Cam follower 132 has a first cam surface having an arc length bounded by points 190 and 192 since rotor housing teeth 162 are captured between casing lock stops 170 and 172 under normal restraint conditions. It slidably contacts only 191. The first cam surface 191 has a first, preferably shortest, radial distance 210 to the axis of rotation of the rotor 120. By comparison, the outermost cam surface 205 has a maximum radial distance 218. 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 teeth 162 are raised, thereby causing the teeth 162 to be rotated by a subsequent clockwise or counterclockwise rotation of the adjustment tool. The casing lock stopper 172 is rotated upward. After the adjustment tool is removed and when 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, the rotor teeth 160 show that the rotor teeth 162 are captured between the pair of lock stoppers 172 and 174 in the constrained condition (see FIG. 6B), and this is a point on the cam structure of the rotor 120. Sufficient to prevent rotation of rotor 120 relative to cam follower 132 beyond 192 and point 194 is shown as not in contact with any stop. The points 192 and 194 correspond to the second arc length of the second cam surface 193. Surface 193 is located at a second radial distance 212 that is greater than distance 210 and less than distance 218 (see FIGS. 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.

  The outer radial movement of the cam follower 132 causes the high torque to increase as the cam follower slides from the first cam surface 191 (see FIG.6A) to the second cam surface 193 (see FIG.6B). By being applied to the rest of the spring arm unit 130 by 132, the urging force of the valve spring 134 against the ball 144 is increased. Improved accuracy of pressure control is achieved by placing the rigid cam follower 132 in contact with the selected cam surface and the flexible element or spring 134 in contact with the valve ball 144. The improvement is the opening of the ball 144 from the valve seat 142 by only needing to bend the elastic spring element 134 (this applies a constant spring force to the ball 144). The opening pressure and the overall valve performance do not depend on the pivoting of the spring arm unit 130.

  A third opening pressure setting is shown in FIG.6C, where the rotor teeth 162 only have a third cam surface 195 between points 194 and 196 where the cam follower 132 is located at a third radial distance 214. Is positioned between the casing stoppers 174 and 176 so as to cover them. To achieve a fourth pressure setting (see FIG. 6D), both rotor teeth 160 and 162 are used for casing stops 170 and 176, respectively. Thereby, the cam follower 132 is limited to the fourth cam surface 197 between the points 196 and 198.

  In FIGS.6E-6G, the fifth pressure setting to the seventh as rotor teeth 160 are continuously captured between each of the casing lock stopper pairs 170-172, 172-174, and 174-176. Are shown. This causes the cam follower 132 to move onto the fifth cam surface 199 between points 198 and 200 (see FIG.6E) and onto the sixth cam surface 201 between points 200 and 202 (see FIG. 6E). 6F), as well as a seventh cam surface 203 between points 202 and 204 (see FIG. 6G).

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

  A final setting of about at least 400 mm of water (3,920 Pa) (see FIG. 6H) 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 causes the stiffening element 133 of the spring arm unit 130 to be pressed against the valve spring 134, thereby reducing the effective length of the valve spring 134 and thereby the biasing force applied to 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 increment.

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

  The use of torsion spring 220 is optional and possible, as only spring element 134 contacts the movable valve member. As a result, additional spring force from the torsion spring 220 can be used to press the bearing surface 235 of the cam follower 132 against the cam surface of the rotor. This bias provided by torsion spring 220 enhances the rotational position of the spring arm that reflects the intended cam displacement without the force otherwise applied to the ball or other movable valve member. This is more accurate and repeatable, as it reduces the need to maintain minimal friction, such as when the valve spring element alone supplies the force required to maintain the cam follower on the cam surface It 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 a partial cross-sectional view at a further depth. The opening 222 into the lower cam portion of the rotor 120 prevents negative pressure due to deployment below the rotor 120, i.e., the opening 222 ensures an even pressure as cerebrospinal fluid passes through the valve unit 100.

  In FIGS. 8 and 10, the first pressure setting from the first pressure setting when the rotor 120 is translated upward by magnet attraction using an adjustment tool so that the rotor teeth 162 can move away from the casing lock stopper 172. A transition to a pressure setting of 2 is shown. In FIG. 8, the cam follower 132 is shown at a point 192 passing from the first cam surface 191 to the second cam surface 193. The lower cam section 122 has sufficient height relative to the cam follower bearing surface 235 to ensure that the cam follower 132 remains in contact with the cam surface of the cam portion 122 in both restrained and unrestrained conditions. Have The rotor retaining spring 150 (see FIG. 10) is compressed, and its bias is overcome by the magnet attraction between the rotor 120 and the adjustment tool while the adjustment tool is positioned on the valve unit 100. You. FIG. 10 also shows an upper composite ruby bearing 242 and a lower composite ruby bearing 139 for the upper axle 136 and the lower axle 138 of the spring arm unit 130, respectively. The synthetic ruby bearing 240 rotatably supports the rotor axle 126.

  The location of components and features within the valve unit 100 in the final "substantially off" or substantially closed setting shown in FIG. 6H is shown in FIG. Further clockwise rotation of the rotor 120 is prevented by a rotation stopper or limiter 250 that projects downwardly from the upper casing 104 and contacts the fingers 127. The rotation stopper 250 contacts the opposing surface of the finger 127 when the rotor 120 is completely swiveled counterclockwise in the unconstrained condition. The actual position of the rotation stop 250 may be shifted to the right of the position shown in FIG. 11 so that the cam follower 132 can follow almost all portions of the cam surface 205. Preferably, one side of the stopper 250 prevents direct rotor movement from the lowest setting to the highest setting so that the cam follower contacts the highest setting cam protrusion when the rotor is at the lowest setting. Is also prevented. The other side of the 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 stopper 250 that blocks the rotor housing 124 and the spring 150 that is compressed between the rotor 120 and the upper casing 104 for this unconstrained condition.

  13 and 13A, further details of selected features and components of rotor 120 in one configuration are shown. In particular, housing portion 124 is shown integrally with cam portion 122. A pocket cavity 260 (see FIG. 13) houses a magnet 123 and a tantalum reference ball 129, which sets the actual pressure setting 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 magnet 125, pocket 262, and rotor teeth 160 is shown.

  Therefore, the specific design of the abutting rotor tooth-lock stopper vertical surface, which requires only a vertical pull up by the adjustment tool to overcome the rotor tooth-lock stopper abutment to change the pressure setting, Enables prevention of valve setting changes in the presence of external magnets. Since these vertical surfaces do not provide an introduction that encourages upward movement on the casing stop, the rotor tooth-lock stop abutment mechanically prevents rotational movement from a given performance setting. Axial movement is limited due to the orientation of the rotating component magnets that, when interacting with a strong north or south magnet, induces a combination of attractive and repulsive forces. In addition, the interference between the axle of the rotating component and the bushing surface mechanically limits the tilt associated with the attraction / repulsion to external magnetic fields.

  However, the lower 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 upward from the lower casing 106. Only when properly locked, engaged, or mounted within 171 ", 171" ", the programmable implantable fluid drainage valve will resist magnetic fields from external magnets. The device has been tested to 100% resist changes in valve settings for magnetic fields of at least up to about 3T, as long as the field resistance mechanism is properly engaged. 6A-6H show proper engagement of the field resistance mechanism for each of the eight valve settings. During programming or adjustment of the valve, the downwardly protruding teeth 160, 162 when vertically lowered are undesirably mounted on top of one of the lock stops 170, 172, 174, 176. The possibility exists mechanically. FIG. 8 shows just such an example, with the teeth 162 resting on top of the lock stopper 172. One of the teeth 160, 162 rests on top of the lock stops 170, 172, 174, 176 (i.e., rests or engages properly in each setting pocket defined between adjacent lock stops). If not, the programmable implantable fluid drainage valve is at risk that, when exposed to a magnet, may undergo undesirable changes in valve settings. Heretofore, conventional programming valves have determined whether the magnetic field mechanism is properly locked or engaged, i.e., the teeth 160, 162 are properly positioned within the setting pockets 171, 171 ', 171' ', 171' ''. It cannot be confirmed whether or not it is placed. It is therefore uncertain whether the valve will resist the possibility of a change in setting when exposed to a magnetic field. To ensure, after exposure to external magnets (e.g., after undergoing an MRI procedure), the programmed valve settings are reconfirmed by medical personnel using the indicator tools in the relevant toolset. It must be. Even though the likelihood that the teeth will not be properly seated is relatively small, the potential for changing valve settings upon exposure of the valve to an external magnet remains a particular problem. This is because an implantable programmable fluid drainage valve cannot be guaranteed to have a resistance to a magnetic field within a predetermined range (up to about 3 T).

  The improved implantable valve drainage system of the present invention allows the downwardly projecting teeth 160, 162 to be positioned in each mounting pocket 171, 171 ', 171' ', 171' 'after programming of the valve settings or prior to exposure to an external magnet. Checking whether or not the valve is properly seated in essence essentially locks the field resistance mechanism in place to ensure that valve settings do not change when the valve is exposed to external magnets Alternatively, this uncertainty is eliminated by checking whether or not they are 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 adjustable valve unit rotor 120, as shown in FIG. Prepare. As an example, referring to FIG. 6J, a fixed reference magnet 800 is located in the valve flow direction between the proximal connector 14 and the sampling / pump chamber 18 in the valve. However, this position of the fixed reference magnet 800 within the valve may be changed as desired. Further, the fixed reference magnet 800 can be located on a card externally located over the valve / patient tissue to assist the electronic tool, instead of being disposed within the implantable valve itself. . Preferably, the fixed reference magnet 800 has a magnetic intensity (nominal 2.7 × 10 ^ ^-9 Weaver meter) different from the primary magnet elements (nominal 3.2 × 10 ^ ^-9 Weaver meter) 123, 125 and appropriate identification by the sensor array. Have different nominal distances between the magnets (ie, the distance between the reference magnet 800 and the primary magnet 123 when compared to the distance between the primary magnet elements 123, 125). The nominal distance between the primary magnet elements 123, 125 is about 5.48 mm measured from the lower inward angle to the lower inward angle. The nominal distance of the fixed reference magnet 800 is about 17.5 mm from the rotating component axle to the leading edge of the reference magnet 800. The fixed reference magnet 800 is aligned with an arrow or mark "A" on the programmable valve 10 itself indicating the direction of fluid flow through and a center point "C" intermediate between the magnet elements 123,125. A line through these three points (referred to as the flow direction line) is used for the programmable shunt valve 10 using the integrated locator / indicator tool 1405 in the example tool set 1400 in the case as shown in FIG. It is the basis for determining orientation. The locator and indicator tools described herein and shown in the accompanying drawings have been integrated into a single device for simplicity of operation, but could also be two separate devices. Please note. However, it is expected that some, none, or all of the tools in the tool set will be integrated, and are within the intended scope of the invention. Further, the tool set includes an adjustment tool 1415, a screwdriver 1410, and a spare battery 1408.

  In FIG. 14A, a top perspective view of the integrated locator / indicator tool 1405 and the adjustment tool 1415 of FIG. 14 is shown before the adjustment tool 1415 is inserted into the cavity 1420 of the integrated locator / indicator tool 1405. FIG. 14B shows the adjustment tool 1415 after insertion into the cavity 1420.

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

  FIG. 16 is an exploded perspective view of the adjustment tool 1415 of FIG. In the example shown, the housing 1600 includes an outer housing section 1610 and an upper housing section 1615, each of which is spaced apart from one another. A magnet assembly 1620 is disposed within the outer housing section 1610. In particular, the magnet assembly 1620 of FIG.16A comprises two semi-circular magnets 1630, 1650 connected by a yoke 1650 and separated by a shield magnet 1640 that reorients the magnetic field to allow greater 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 semicircular magnets 1630, 1635 are mounted with their flat sides flush with the shield magnet 1640, as shown in FIGS. 16, 16A, 16B, and 16D. Rotated until 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 FIG. 13). The shield magnet 1640 is partially pushed back by the semi-circular magnets 1630, 1635, and thus by the yoke 1650 attached to the top of the shield magnet 1640, which when assembled is also in contact with the two semi-circular magnets 1630, 1635. It is pressed down. These components of the magnet assembly 1620 include two semi-circular magnets 1630, 1635 inside the outer housing section 1610, with the semi-circular magnet facing the tantalum ball 129 facing the "1-8 stops". Inserted into outer housing section 1610 when assembled together to be received in each recess defined in the surface. As can be seen in the top view of FIG. 16C, the outer housing section 1610 includes a plurality of vertical ribs 1655 connecting semi-circular magnets 1630, 1635. A cylindrical spacer 1625 is positioned above the yoke 1650 (see FIG. 16D). The upper housing section 1615 with the marking indicator is fixed to the outer housing section 1610 forming the assembled adjustment tool 1415.

  The magnetic field pattern generated by each of the magnet elements 123, 125 disposed within the housing 124 of the rotor 120 and the fixed reference magnet 800 is provided by a two-dimensional array of three-axis magnetoresistive sensors 1570 of an integrated locator / indicator tool 1405. Is detected. When these three magnets are detected, a center point “C” intermediate between the two detected magnet elements 123, 125 is located (FIG. 6J). The flow direction line `` DOF '' (i.e., the reference line) is identified as passing through the detected fixed reference magnet 800, and the arrow or marking `` A '' indicates the flow direction on the implantable valve and the center point `` C Is located midway between the two detected magnet elements 123,125. A rotation vector "RV" is defined as connecting the two detected magnet elements 123,125. Thereafter, the rotating component angle α is measured between the flow direction line “DOF” and the rotation vector “RV”. Specifically, the rotational component angle α that moves counterclockwise starting from the flow direction line “DOF” (as a starting point reference line) and intersecting the rotation vector “RV” is measured.

  Once the rotating component angle α is ascertained based on the three magnets detected in the adjustable valve unit, the valve will be adjusted to its respective setting for that particular implantable valve, as described in further detail below. A comparison is made against a stored predetermined mechanical angle interval value of the pocket. If the measured rotational component angle α matches the predetermined mechanical angular spacing of any set pocket, the field resistance mechanism is considered properly locked or engaged. In contrast, if the measured rotational component angle α does not match the predetermined mechanical angular spacing of any of the setting pockets, then the reluctance mechanism is found to be not properly locked or engaged. Visual suggestions (e.g., text and / or icons) are generated on the display 1555 of the integrated locator / indicator tool 1405 and the field resistance mechanism is found to be properly engaged and / or not properly engaged You may confirm that you do. In addition to such visual display indicators, tactile indicators may be provided. If the field resistance mechanism is not properly engaged, the instructions and steps to take to reprogram the valve settings using the adjustment tool 1415 and then re-check if the field resistance mechanism is properly engaged May be displayed on the display 1550 of the integrated locator / indicator tool 1405.

  Preferably, each time a valve setting is programmed using the adjustment tool 1415, the integrated locator / indicator tool 1405 according to the present invention then checks whether the field resistance mechanism is properly locked or engaged. Used to Alternatively, the integrated locator / indicator tool 1405 of the present invention can be used to confirm proper engagement of a field resistance mechanism prior to intentional exposure to an external magnet, for example, prior to an (MRI) procedure. Is also good.

  As described above, based on this particular design of the valve, a predetermined mechanical angular spacing with respect to the flow direction of the shunt valve (as identified by the arrow marking `` A '') will result in each setting pocket 171, 171 ', 171' ', 171' ''. Each setting pocket 171, 171 ', 171 ", 171"' is restrained on at least one side by a lock stopper. Based on this valve configuration, in some designs, such as a Strata® programmable valve, each setting pocket is constrained on both sides by an adjacent lock stopper. That is, each lock stopper has a clockwise leading edge and a counterclockwise leading edge. Thus, each setting pocket is, on one side, by the counterclockwise leading edge of the first lock stopper and, on the other side, by the clockwise leading edge of the second lock stopper adjacent to the first lock stopper. Be bound. Regardless of whether the setting pockets are constrained by one or two locking stops, in each case, the mechanical angular spacing or angular width of each setting pocket for each particular programmable valve is determined by a fixed reference magnet. Can be dynamically adjusted based on skin depth, as it has been found that can affect the identification of setting pockets that change slightly further away from the valve. The distance between the rotating component magnets can be used to determine depth. Thus, the mechanical angular spacing or width is controlled by the valve design. Sensor arrays do not specify pockets, but magnetics are not quite as simple as simple magnetic field measurements. Characterization has shown that the magnetic field changes based on the distance of the integrated locator / indicator tool from the sensor array. Thus, the actual boundaries of the setting pocket will change based on the distance from the sensor array. This has been confirmed by testing multiple valves at extreme values of the setting pocket location and distance from the locator / indicator tool. An algorithm determines the distance based on the pre-measured valve and calculates where the boundary should be. The predetermined mechanical angle interval of each setting pocket is represented by two mechanical angle boundary values that define both sides of the setting pocket. The first mechanical angle boundary value represents the mechanical angle of the leading edge of each lock stopper moving counterclockwise starting from the flow direction as a reference, while the second mechanical angle boundary measurement is Is added to the first measured mechanical angle boundary in the clockwise direction. The first mechanical angle boundary value and the second mechanical angle boundary value represent a predetermined mechanical angle interval of the specific setting pocket. The first mechanical angle boundary value and the second mechanical angle boundary value for each setting pocket of a particular programmable valve are identified in advance and stored in memory, for example, in a locator / indicator tool.

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

  Referring to FIGS. 17A and 17B, the lower casing 1700 and the rotating structure 1705 of the Strata® Programmable Valve have a different configuration than the configuration of the CODMAN CERTAS® Plus Programmable Valve. Specifically, five setting pockets 1710, 1712, 1714, 1716, 1718 are disposed in the lower casing 1700 in a 360 degree circular configuration, with each setting pocket having an adjacent lock stopper 1720, 1722, 1724, 1726. , 1728. That is, each of the five setting pockets 1710, 1712, 1714, 1716, 1718 is adjacent on one side by the clockwise leading edge of the first lock stopper and on the other side by the first lock stopper. It is defined by the counterclockwise leading edge of the second lock stopper. Thus, each of the five setting pockets has a fixed angular width or mechanical angular spacing.

  The safety features of the present invention are also applicable to other configurations, and the magnetic field resistance mechanism, if properly engaged or locked, will fit within the corresponding cavity / pocket / recess. With one or more structural components placed. Instead of receiving one or more downwardly protruding teeth (as described above) in respective setting pockets defined by one or more locking stops, U.S. Pat. In U.S. Pat.No. 5,643,194, which is hereby incorporated by reference in its entirety, one alternative where a cylindrical mating lead in an element or component is received within a respective complementary shaped cavity, notch, opening, or pocket. The design is described.

  The plan view of FIG. 18A shows the valve body 1 without the upper cover and the casing 3. 18A and 18B is formed at the periphery of the substantially cylindrical central portion 2a. The valve body 1 includes a cylindrical and flat inner chamber 5 formed between the lower wall 3b, the side wall 3a of the casing 3, and the upper cover 2. An inlet pipe 6 and a drain pipe 7 are formed in the side wall 3a of the casing 3, and the inner ends of the pipes 6 and 7 are arranged diagonally in the chamber 5. The inlet pipe 6 and the drain pipe 7 are connected to a catheter for supplying fluid and another catheter for draining fluid, respectively.

  A rotating structure or rotor 8 with an H-bar is rotatably mounted in the chamber 5 about a central axis 9. A stop element 21 protruding from the lower wall 3b of the casing 3 is provided to limit the rotational displacement of the rotor 8. The rotor 8 accommodates the micromagnets 12 and 13 in a state where the opposing surfaces of the micromagnets 12 and 13 are formed of opposite magnetic poles (N and S), and serves as guide means for the movable parts 10 and 11. A side branch 8a that plays a role is provided on both sides of the central axis 9. The movable parts 10 and 11 are displaced linearly within the rotor 8 substantially radially thereof to activate the locking mechanism. In particular, the locking mechanism extends outwardly of the substantially cylindrical central portion 2a to receive complementary mating leads in elements 10a and 11a (e.g., cylindrical lugs) protruding from movable portions 10 and 11, respectively. It comprises a series of open mating pockets, notches or cavities 4 arranged in a circle, defined radially inward along the sides. Between adjacent opening notches or cavities 4 is a portion of a substantially cylindrical central portion 21, hereinafter referred to as a compartment post.

  The valve body 1 includes a check valve including a ball 14 and a conical seat 15 disposed at an inner end of the inlet pipe 6. A semi-circular leaf spring 16 is fixed to one side branch 8a of the rotor 8, parallel to the side wall 3a of the chamber 5, compressing the ball 14 in the seat 15, and The passage of fluid into the chamber 5 via 6 is regulated and, where appropriate, prevented. As in the valve design of FIG. 1, the alternative valve design of FIG. 18A may also include a fixed reference magnet 800.

  FIG. 18B shows a prior art external setting device 17 arranged on the valve body 1 of FIG. 18A. The external setting device 17 comprises two magnets 18 and 19, for example made of samarium-cobalt, whose opposing faces consist of opposite magnetic poles (N and S) and are associated with the valve body 1. It has a larger magnetic mass than the movable micromagnets 12 and 13. The magnets 18 and 19 are mounted on a common annular support 20, for example made of soft iron, and are external to the two movable micromagnets 12 and 13 when the lugs 10a and 11a are engaged in the cutouts or cavities 4. The magnetic poles are diagonally opposed to and separated from each other by a distance substantially equal to or greater than the distance separating the magnetic poles.

  Next, the operation of the external setting device 17 of FIG. 18B will be described. FIG.18A shows the valve body 1 in the locked position, i.e., the cylindrical lugs 10a, 11a are both engaged in respective notches or cavities 4, and the magnetic poles of the micromagnets 12, 13 are reversed so that the magnetic poles are reversed. As a result of the attraction, it locks in place therein.

  FIG. 18B shows the valve body 1 in the unlocked position, with both cylindrical lugs 10a, 11a disengaged from the notch or cavity 4. To unlock the valve (disengage or remove the cylindrical lugs 10a, 11a from the respective notches or cavities 4), the external setting device 17 shown in FIG.18B is vertically aligned with the valve body 1 and As a result, the magnets 18 and 19 having opposite magnetic poles (N and S) are positioned on both sides of the micro magnets 12 and 13 symmetrically with respect to the center axis 9 of the chamber 5. Of course, the strength of the magnets 18, 19 must be higher than the strength of the micro magnets 12, 13 to overcome the attractive force existing between the micro magnets 12, 13.

  Keeping 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 setting the setting device near the opposite south and north poles of the micromagnet By arranging the north and south poles, the two outer magnetic poles of the micromagnets 12, 13 are exposed to an outer attractive force that is higher than the central mutual attractive force between the two inner magnetic poles. This results in the two micromagnets 12, 13 with their movable parts 10, 11 separating symmetrically and simultaneously towards the outer edge of the chamber 5, thereby unlocking or disengaging the rotor 8. And free rotation becomes possible. This unlocking or disengaging of the rotor 8 changes the position of the rotor 8 by pivoting the setting device 17 about the central axis of the valve chamber and thereby simultaneously driving the rotor. As a result, it is possible to change the operating pressure and the throughput of the valve. To lock the rotor 8 in the new desired position, the setting device 17 is pulled and moved away perpendicular to the face of the valve. Since the two micromagnets 12, 13 no longer experience the external perimeter attraction by the magnets 18, 19, the micromagnets 12, 13 re-approach each other under the influence of their mutual attraction, and thus each notch Alternatively, the lugs 10a, 11a are placed (ie, locked) in the cavity 4.

  This type of valve with movable micromagnets requires the presence of strong external magnetic or electromagnetic fields because the two movable micromagnets 12, 13 cannot be disengaged simultaneously from their cavities in the presence of a unidirectional magnetic field Below realizes the magnetic field resistance to changes in valve settings. As long as two movable micromagnets 12 and 13 are located on either side of the central axis of the valve, if one of the micromagnets is pulled towards the perimeter of the chamber, the other will be pushed back into the locking cavity. It is. An external setting device as shown in FIG. 18B is required for unlocking or disengaging the valve, ie for symmetrically separating the micromagnets 12,13.

  However, the above-described valve shown in FIGS.18A and 18B is only exposed to external magnets when the cylindrical lugs 10a, 11a are properly seated, engaged, or locked in their respective notches or cavities 4. No change in valve setting. When unlocked, lugs 10a, 11a are properly seated or engaged within each notch or cavity 4, similar to that discussed above in connection with CODMAN CERTAS® Plus Programmable Valve. Instead, the area of the outer perimeter of the substantially cylindrical central portion 2a, hereinafter referred to as the compartment post (the outer perimeter of the substantially cylindrical central portion 2a between adjacent notches or cavities 4) (The area along the part) may be re-entered.

  According to the present invention, whether the valve in FIG.18B is properly locked in place (i.e., whether the cylindrical lugs 10a, 11a are properly engaged or seated in each notch or cavity 4) ) Exists in two different ways. If the valve in FIG.18B includes a fixed reference magnet 800, one way to confirm proper engagement is based on the detected angular position of the micromagnet 12 (see above using integrated locator / indicator tool 1405). According to the method described in detail above). Once the angular position of the micromagnet 12 has been determined, this angular position is compared against a predetermined angular spacing of each notch or cavity 4. If the detected angular position of the micromagnet 12 matches a predetermined angular interval of one of the notches or cavities 4, the valve is considered to be properly locked (i.e., lugs 10a, 11a Are properly engaged or placed in respective notches or cavities 4). In contrast, if the detected angular position of the micromagnet 12 does not match the predetermined angular spacing of any of the respective notches or cavities 4, the valve will not lock properly (i.e., lugs 10a, 11a is mounted on a compartment post). In such latter case, the user again instructs to use the external setting device 17 to adjust the valve and then check to see if the valve is properly engaged, seated or locked. Is done.

  An alternative method for determining whether the valve of FIG. 18B is locked or properly engaged is based on a measured distance between the centers of the two micromagnets 12,13. As discussed in detail above, as the external setting device 17 is withdrawn from the valve, the micromagnets 12, 13 pull on each other to hold them in place. If the micromagnets 12, 13 are properly placed, engaged, or locked in each notch or cavity 4, the separation between the centers of the micromagnets 12, 13 is determined by a predetermined appropriate 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 the compartment posts). When placed, the center of each micromagnet 12, 13 will have a greater separation from each other than a predetermined locking value. Therefore, this alternative method can also use the same integrated locator / indicator tool 1405 to detect the center of each micromagnet 12, 13 on the rotating structure and measure the distance between them. Then, a comparison is made with a predetermined locking value. Of course, the algorithm of the integrated locator / indicator tool 1405 must be modified according to this alternative. If the measured distance is equal to a predetermined locking value that indicates proper locking, the valve is properly engaged or locked (i.e., lugs 10a, 11a are properly inserted into their respective notches or cavities 4). If the measured distance is greater than the predetermined locking value, the valve is improperly engaged or unlocked (i.e., lugs 10a, 11a are Above). As in other embodiments, the user is instructed to reprogram the valve to the desired setting and to confirm again that the valve is properly locked or engaged.

  The improved toolset of the present invention, which uses a sensor array for use with a programmable valve, provides an additional safety feature to ensure that the field resistance function of the valve is properly engaged. This additional safety feature may be triggered each time the valve is programmed to a new setting or prior to exposure to an external magnet, for example, prior to an MRI procedure. The tool set of the present invention having this additional safety feature, when locked in place, places or engages a structural component within a corresponding notch, recess, cavity, pocket, or other complementary shaped area. It is suitable for use with any type of programmable valve.

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

  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 internal chamber
6 Inlet pipe
7 Drain pipe
8 Rotor
8a Side branch
9 center axis
10 Programmable shunt valve device, programmable valve, programmable shunt valve, moving parts
10a cylindrical lugs, elements
11 Moving parts
12 Movable micro magnet, micro magnet, shunt housing, housing
13 Movable micro magnet, micro magnet
14 Proximal connector, ball
15 Conical seat, seat
16 Semicircular leaf spring
16 distal connector
17 External setting device
18 Sampling / pump chamber, magnet, sampling chamber or pump chamber
19 magnet
20 Common annular support, needle guard
21 Central part, stop element
22 Backing plate
30 passages
100 Adjustable valve units, valve units
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 part
123 Primary magnet element, primary magnet
124 Upper magnet housing, housing, rotor housing, housing part
125 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 follower, cam follower
133 Stiffening element
134 Elastic spring element, spring element, spring, valve spring
136 upper axle
138 Lower axle, axle
139 Lower synthetic ruby bearing, bearing
140 Valve mechanism
142 Valve seat, seat
144 Movable valve members, valve members, valve balls, balls
150 Rotor holding spring, holding spring, spring
160 downward protruding teeth, rotor teeth, teeth
162 Downward protruding teeth, rotor teeth, teeth, rotor housing teeth
170 Casing lock stopper, lock stopper, casing stopper,
171 Setting pocket, mounting pocket
171 'setting pocket, mounting pocket
171 '' setting pocket, mounting pocket
171 '''setting pocket, mounting 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 2nd cam surface
194 places
195 Third Cam Surface
196 locations
197 4th cam surface
198 places
199 5th cam surface
200 locations
201 6th cam surface
202 locations
203 7th cam surface
204 locations
205 outermost cam surface
206 locations
210 1st radial distance, distance
212 Second radial distance
214 Third radial distance
218 Maximum radial distance, distance
221 First Leg
222 opening
223 Second Leg
230 magnifying pad
232 posts
233 triangle head
234 rivets
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 Bump or protrusion
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 recess
1525 Chimney
1530 cylindrical section
1535 channels
1540 Top layer, top cover
1542 opening
1550 2nd aperture, display
1555 display
1560 button
1565 Battery enclosure assembly
1570 3-axis 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 component
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)

Implantable programmable with a field resistance mechanism comprising an adjustable valve unit with a rotating configuration and a pair of primary magnet elements for programming the adjustable valve unit to a desired valve setting A method for determining whether to be properly engaged in a bodily fluid drainage system, comprising:
Using a toolset to determine whether the field resistance mechanism is properly engaged,
Issuing a warning if the field resistance mechanism is or is not properly engaged.   The step of determining whether the magnetic field resistance mechanism is properly engaged includes: (i) measuring a detected one of the pair of primary magnet elements with respect to a direction of fluid flow through the implantable bodily fluid drainage valve. 2. The method of claim 1, wherein the method is based on the angular position and / or (ii) the measured separation between each center of the pair of primary magnet elements.   The step of determining is based on the measured angular position of the detected one of the pair of primary magnet elements with respect to the direction of fluid flow through the implantable bodily fluid drainage valve, such that the magnetic field resistance mechanism is properly engaged. 3. The method according to claim 2, wherein it is determined whether the operation is performed. The implantable bodily fluid drainage valve comprises a fixed reference magnet aligned with a marking on the implantable bodily fluid drainage valve indicating a direction of fluid flow therethrough and a midpoint between the pair of primary magnet elements. An upper casing having a plurality of downwardly projecting teeth in each of which the pair of primary magnet elements are located; and a lower casing comprising a plurality of corresponding setting pockets for receiving the downwardly projecting teeth. Wherein each of the setting pockets is restrained on at least one side by a lock stopper projecting upward from the lower casing toward the upper casing,
The step of determining
Using the sensor array in the toolset to detect a magnetic field pattern generated by (i) the fixed reference magnet and (ii) each of the pair of primary magnet elements;
Locating the center point in the middle between the detected pair of primary magnet elements;
(i) an arrow indicating the direction of fluid flow through the implantable bodily fluid drainage valve, (ii) the located center point intermediate between the detected pair of primary magnet elements, and (iii). Defining a flow direction line as a reference line intersecting the detected fixed reference magnet;
Defining a rotational component vector connecting the centers of the detected pair of primary magnet elements,
Measuring a rotating component angle that moves in a counterclockwise or clockwise direction from the defined flow direction line as a starting point and intersects the rotating component vector;
Comparing the measured rotating component angle to a predetermined mechanical angle interval for each of the setting pockets as stored in a memory device, wherein the measured rotating component angle is the setting. If any of the pockets meet the predetermined mechanical angular spacing, the field resistance mechanism is deemed to be properly engaged and, in contrast, the measured rotating component angle is set to the setting. 4. If the predetermined mechanical angular spacing of any of the pockets does not match, the field resistance mechanism is deemed to be not properly engaged.   5. The method of claim 4, wherein the fixed reference magnet is disposed between a proximal connector of the implantable bodily fluid drainage valve and a pump chamber.   5. The method of claim 4, wherein the plurality of lock stops and the corresponding setting pockets are equal in number.   The method of claim 1, wherein the determining is performed after programming of a valve setting of the implantable bodily fluid drainage valve.   2. The method of claim 1, wherein said determining is performed prior to a magnetic resonance imaging examination procedure.   The method of claim 1, wherein issuing an alert comprises generating a visual and / or tactile indication.   The magnetic field resistance mechanism is engaged when the plurality of downwardly protruding teeth are properly placed in the corresponding setting pocket, but the magnetic field resistance mechanism is configured such that any one of the plurality of downwardly protruding teeth is used. 5. The method of claim 4, wherein the method does not properly engage when resting on one of the lock stops.   The rotating structure is mounted rotatably about an axis within the housing, a substantially cylindrical central portion is fixedly mounted on the shaft, and the rotating structure has opposite surfaces. Side branches are provided on opposite sides of the axis of the movable part each accommodating a respective one of the pair of primary magnet elements having opposite magnetic poles, and mating leads in the element each extend from each of the movable parts. And the movable portion is the mating lead in a series of circular pocket-shaped elements defined radially inward along an outer perimeter of the substantially cylindrical central portion. 3. The method of claim 2, wherein the movable portion is linearly displaceable within the rotating structure substantially radially of the movable portion to actuate the movable portion.   The magnetic field resistance mechanism is engaged when the mating lead in an element is placed in one of the pockets, but the magnetic field resistance mechanism engages the mating lead in an element. 12.If not located along the outer perimeter of the substantially cylindrical central portion between adjacent pockets, they will not engage. Method. The step of determining
Determining one angular position of the pair of primary magnet elements and comparing the detected angular position with the predetermined angular interval of each of the pockets, wherein the detected angular position is If the predetermined angular spacing of one of the respective pockets is met, the field resistance mechanism is considered to be properly engaged and, in contrast, the detected angular position is 12. The method of claim 11, comprising: if the predetermined angular spacing of any of the respective pockets does not match, the field resistance mechanism is deemed not properly engaged. . The step of determining
Detecting the center of each of the pair of primary magnet elements;
Calculating a separation distance 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 field resistance mechanism is properly engaged. If the calculated separation is greater than the predetermined locking value, then the field resistance mechanism is deemed not to be properly engaged. The method according to claim 11.

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