JP2020054730A - Electronic tool set for use with multiple generations of implantable programmable valves with or without orientation functionality based on fixed reference magnet - Google Patents

Abstract

To provide a method for using a universal electronic tool set for indicating and adjusting an implantable programmable bodily fluid drainage valve regardless of whether the implantable programmable bodily fluid drainage valve includes a fixed reference magnet used to determine an angle of orientation of the implantable programmable bodily fluid drainage valve or not.SOLUTION: A magnetic field detection sensor array in an indicator tool of an electronic tool set determines whether or not a fixed reference magnet is present in an implantable programmable bodily fluid drainage valve (step 2010). If the presence of the fixed reference magnet is detected, then the center and direction of flow of an adjustable valve unit is ascertained via electronic feedback from the electronic tool set (step 2025). In contrast, if the presence of the fixed reference magnet is not detected, the center and direction of flow is ascertained via exclusively by manual physical palpation of the valve (step 2040).SELECTED DRAWING: Figure 18

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 relate to an electronic toolset for suggesting and adjusting with automatic switching between multiple generations of implantable bodily fluid drainage valves with and without orientation features.

  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 setting in these aforementioned conventional programmable implantable valves can be adjusted non-invasively after implantation into the body using a rotating structure or rotor having a pair of magnets.

  Each programmable implantable valve is controlled using an associated external toolset that includes one or more devices used to locate the valve, read the current valve settings, and adjust the valve settings. With each improved generation or version of a programmable implantable valve, an associated toolset may be required. However, electronic toolsets used to suggest and adjust to the latest generation of programmable implantable valves often fail on earlier generations or versions of programmable implantable valves. As a result, healthcare professionals need to store multiple versions of the electronic toolset (i.e., not only the latest improved version, but also previous versions) and maintain each electronic toolset with only compatible programmable implantable valves. It needs to be used properly. In addition, the generation of the valve implanted in the patient upon which the appropriate toolset is selected is not always apparent from the patient's record or x-ray identification.

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

  Therefore, it is used in the suggestion and adjustment of multiple generations or versions of a programmable implantable valve that allows automatic switching between generations of the valve with or without an orientation feature without additional input by the clinician. It is desirable to develop a generic or compatible electronic toolset for

  One aspect of the present invention suggests multiple generations or versions of a programmable implantable valve that allows automatic switching between generations of the valve with or without an orientation feature without additional input by the clinician. And a universal or compatible electronic toolset for use in adjustment.

  Another aspect of the present invention is an implantable programmable fluid drainage valve, whether or not the implantable programmable fluid drainage valve comprises a fixed reference magnet used to determine the orientation angle of the implantable programmable fluid drainage valve. For using a general purpose electronic toolset for making and adjusting the invention, wherein the implantable programmable fluid drainage valve comprises an adjustable valve unit having a pair of primary magnet elements. Using the magnetic field sensing sensor array in the indicator tool of the electronic tool set, it is determined whether a fixed reference magnet is present in the implantable programmable fluid drainage valve. If the presence of a fixed reference magnet in the implantable bodily fluid drainage valve is detected, the center of the adjustable valve unit is located using the indicator tool of the electronic tool set and the flow direction of the adjustable valve unit is determined. , Without the need for manual body palpation, and based solely on the electronic feedback provided by the indicator tool of the electronic tool set, the indicator tool of the electronic tool set can be used to locate the center of the adjustable valve unit and Aligned in the flow direction, the current valve setting is read using the indicator tool of the electronic toolset. In contrast, if the presence of a fixed reference magnet in the implantable bodily fluid drainage valve is not detected, the center of the adjustable valve unit is located using the indicator tool of the electronic toolset and the adjustable valve unit is located. The flow direction is established only by hand palpation, without using electronic feedback from the indicator tool of the electronic tool set, the indicator tool of the electronic tool set moves to the localized center and flow direction of the adjustable valve unit. The aligned and current valve settings are read using the electronic tool set indicator tool.

  Yet another aspect of the invention is an implantable, comprising an implantable programmable fluid drainage valve having an adjustable valve unit with a pair of primary magnet elements for programming the implantable programmable fluid drainage valve to a desired valve setting. The present invention relates to a programmable bodily fluid drainage valve system. The system also includes a universal electronic toolset for indicating and adjusting an implantable programmable fluid drainage valve. Among them, a universal electronic toolset includes a magnetic field detection sensor array to (i) detect a pair of primary magnet elements and (ii) determine the presence or absence of a fixed reference magnet in an implantable programmable body fluid drainage valve. And an indicator tool having: A circuit is provided for determining the center of the adjustable valve unit based on the detected pair of primary magnet elements. Such a circuit determines the angular orientation of the implantable programmable bodily fluid drainage valve solely by electronic feedback from the toolset if a fixed reference magnet is present, but the hand-based body if no fixed reference magnet is present. A step is generated on the display of the implantable programmable fluid drainage valve for determining the angular orientation and / or center of the implantable programmable fluid drainage valve by palpation alone.

  The foregoing and other features of the 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.

FIG. 2 is a schematic exploded perspective view of a programmable implantable valve device having a fixed reference magnet in addition to a rotating primary magnet associated with an adjustable valve unit. 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 further depth of the adjustable valve unit of FIG. 4 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. 3 shows one of a series of steps for operating an electronic toolset according to the present invention. FIG. 3 shows one of a series of steps for operating an electronic toolset according to the present invention. FIG. 3 shows one of a series of steps for operating an electronic toolset according to the present invention. FIG. 3 shows one of a series of steps for operating an electronic toolset according to the present invention. FIG. 3 shows one of a series of steps for operating an electronic toolset according to the present invention. FIG. 3 shows one of a series of steps for operating an electronic toolset according to the present invention. FIG. 3 shows one of a series of steps for operating an electronic toolset according to the present invention. FIG. 3 shows one of a series of steps for operating an electronic toolset according to the present invention. FIG. 3 shows one of a series of steps for operating an electronic toolset according to the present invention. The implanted valve may be a current valve with an orientation function according to the invention (i.e., using a fixed reference magnet) or an earlier version of an implanted valve without an orientation function (i.e., a fixed reference magnet). 3 is a flow chart of a method for confirming whether or not a magnet is used.

  FIG. 1 shows a 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 adjustable 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 adjustable valve unit 100, fluid enters past 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 adjustable 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 adjustment tool of an electronic tool set is applied, as described in further detail below. is there. The retaining spring 150 biases the rotor 120 down to normal restraint conditions. Preferably, the spring 150 is sufficient to resist the effect of gravity regardless of the position of the adjustable valve unit 100, as described in further detail below, and within the integrated locator / indicator tool of the electronic tool set. Is a coil spring having a sufficient biasing force to resist a magnetic or ferromagnetic object such as a magnet. 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. Axle 138 pivots about a bearing 139 formed of a relatively low friction, relatively 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 144 may be a disc, cone, or other type of plug. At present, spherical balls are preferred as movable valve members. 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 adjustable 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 170, 172, 174, 176 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 161 of the rotor teeth 160 and 162 are circular and the upper surfaces of the casing lock stoppers 170, 172, 174, and 176 each have the rotor teeth in the locked position as shown in the side view of FIG.4A. It has a plurality of facets 163 to form a chiseled introduction shape that facilitates returning to the top. However, the vertical surfaces of the rotor teeth 160, 162 and the lock stops 170-176 abut when engaged and do not "pull out", ie, prevent relative translation as also shown in FIG. 4A. Thus, a pure vertical lift to overcome the rotor tooth-lock stop abutment and change the performance setting must be achieved by an adjustment tool as described in more 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 adjustable valve unit 100 is shown in FIGS. 6-8, where like reference numerals indicate like 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 adjustable 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 a subsequent clockwise or counterclockwise rotation of the adjustment tool to cause the rotor teeth 162 to rotate. Rotates upward on the casing lock stopper 172. 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 are captured in a constrained condition such that the rotor teeth 162 are captured between a pair of adjacent lock stops 172 and 174 (see FIG. Sufficient to prevent rotation of rotor 120 relative to cam follower 132 beyond points 192 and 194 above is shown as not in contact with any stopper. 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.

  6E-6G, a fifth pressure setting when rotor teeth 160 are continuously captured between each of a pair of adjacent lock stoppers 170-172, 172-174, and 174-176 of the casing. To the seventh pressure setting. 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 adjustable 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 to be integral with cam portion 122, similar to monolithic rotor 120a of FIG. 1A. A pocket cavity 260 (see FIG. 13) houses a magnet 123 and a tantalum reference ball 129, which 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, Allows to prevent changes in valve settings even during exposure to external magnetic fields. These vertical surfaces are made of a material that is sufficiently rigid to prevent flexing (e.g., moldable plastics such as polyethersulfone (PES), polysulfone (PSU), polyphenylsulfone (PPSU), etc.) and sufficient wall The rotor tooth-lock stopper abutment allows rotational movement from a given performance setting to be avoided, as it does not provide an introduction that encourages upward movement on lock stoppers composed of part thickness (> 0.2 mm). Mechanically prevented. 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 downwardly projecting rotor teeth 160, 162 of the rotor housing 124 have corresponding setting pockets 171, 171 'defined by at least one of the lock stops 170, 172, 174, 176 projecting upwardly from the lower casing 106. , 171 ″, 171 ′ ″, the programmable implantable fluid drainage valve only resists magnetic fields when properly locked, engaged, or mounted within the 171 ″ ″. The downwardly projecting teeth 160, 162 are desirably on the lock stoppers 170, 172, 174, 176 as shown in FIG. 8 when the rotor teeth 162 are mounted on the lock stopper 172 when lowered vertically. It is possible mechanically to be placed without any. Programmable implantable when rotor teeth 160, 162 are mounted on lock stoppers 170, 172, 174, 176 (i.e., not properly seated in their respective setting pockets defined by the lock stoppers) Fluid drainage valves are at risk of undergoing undesirable changes in valve settings when exposed to magnetic fields, such as during MRI procedures. Heretofore, conventional programming valves have not been able to ascertain whether the rotor teeth 160,162 are properly seated in the setting pockets 171,171 ', 171 ", 171"'. Experimental testing shows that when rotor teeth are properly locked, engaged, or seated in their respective setting pockets, valve settings remain unchanged when subjected to magnetic fields up to about 3T Was confirmed. To ensure, prior to exposure to a magnetic field (e.g., before undergoing an MRI procedure), programmed valve settings must be reconfirmed by medical personnel using the indicator tools in the relevant toolset. Must, or alternatively, medical personnel must use tools to confirm proper engagement. The potential for changes in valve settings when the rotor teeth are not properly seated in the setting pockets during exposure to a magnetic field remains a particular problem, albeit relatively unlikely. This is because implantable programmable bodily fluid drainage valves cannot be guaranteed to have resistance to magnetic fields in such environments.

  The improved implantable valve drainage system of the present invention can be used to determine whether the downwardly projecting rotor teeth 160, 162 are properly seated in their respective mounting pockets 171, 171 ', 171' ', 171' ''. , That is, whether the field resistance mechanism is properly engaged to perform its intended function, thereby eliminating this uncertainty.

  This configures the programmable shunt valve 10 to include a fixed reference magnet 800 in addition to the primary magnet elements 123, 125 disposed within the housing 124 of the adjustable valve unit rotor 120, as shown in FIG.6I. It is realized by doing. Referring to FIG. 6J, preferably, the fixed reference magnet 800 is located between the proximal connector 14 and the sampling / pump chamber 18 in the flow direction of the shunt valve. Preferably, the fixed reference magnet 800 has a different magnetic strength than the primary magnet elements 123, 125 and a different nominal distance between the magnets (i.e., compared to the distance between the primary magnet 123 and the primary magnet 125, for proper identification). Distance between the reference magnet 800 and the primary magnet 123). 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 17.5 mm from the RC 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 shunt 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 tool set also includes an adjustment tool 1415, a screwdriver 1410, and a spare battery 1408. Note that the locator and indicator tools described herein and shown in the accompanying drawings have been integrated into a single device for simplicity of operation. However, it is expected that none of the tools in the tool set will be integrated, some will be integrated, or all will be integrated and are within the intended scope of the invention.

  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. In the example shown, the housing 1500 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 section 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 section 1505 defines a recess 1520 therein that is complementary in shape and size to the outer contour of the programmable implantable fluid drainage valve. In use, the integrated locator / indicator tool 1405 is positioned with the outer surface of the lower housing section 1505 against the skin of the patient 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 representing individual valve settings in predetermined increments are provided (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 that includes a tray having 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 detects the magnetic field pattern generated by the magnet elements 123, 125 disposed within the housing 124 of the rotor 120 and the fixed reference magnet 800. . 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 and a memory device.

  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, the two semi-circular magnets 1630, 1635 are rotated until their flat sides are flush with the shield magnet 1640, as shown in FIG. 16A. Preferably, the orientation of the magnets 1640, 1630, 1635 is shown in FIG. 16, where the magnetic north side of the shield magnet 1640 is in contact with the semi-circular magnets 1630, 1635, with magnetic north pointing to the bottom of the outer housing section 1610. Should be something like 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 1655 defined on 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 the magnet elements 123, 125 and the fixed reference magnet 800 disposed within the housing 124 of the rotor 120 is detected by a two-dimensional array of three-axis magnetoresistive sensors 1570 of the integrated locator / indicator tool 1405. You. When these three magnets are detected, an intermediate center point "C" between the two detected magnet elements 123, 125 is located. The fixed reference magnet 800 to be detected is connected to an arrow or marking `` A '' indicating the direction of flow on the implantable valve and to a center point `` C '' intermediate between the two detected magnet elements 123, 125. Defines a directional flow line as a reference line for aligning the integrated locator / indicator tool 1405 with the flow line direction on the valve. When the user aligns and orients the tool set with respect to this valve mechanism, the tool set provides suggestions for valve settings based on north / south pole angles to facilitate adjustment of the valve settings.

  17A to 17I are a series of steps in the operation of the improved electronic toolset of FIG. 14 according to the present invention. In FIG. 17A, the integrated locator / indicator tool 1405 is turned on by pressing the power button 1560. Holding the power button 1560 for a predetermined time interval, such as about 3 seconds, causes the integrated locator / indicator tool 1405 to be calibrated, erased, or reset to zero, as shown in FIG. 17B. The lower surface (sensor floor) of the integrated locator / indicator tool 1405 is then positioned against the skin above the implantable valve system, and the implantable valve is moved to the lower housing section 1505, as shown in FIG.17C. In a complementary size and shape recess 1520 defined in the outer surface of the device. The integrated locator / indicator tool 1405 indicates that the two circular visual images shown on the LCD display 1555 are aligned with each other so that the center of the adjustable valve unit 100 is aligned with the center of the adjustable valve unit 100. Until suggested, move in the appropriate direction (as indicated by the four arrows pointing in different directions). Once the locator / indicator tool 1405 is centered above the adjustable valve unit 100, then in FIG. (In the form of a keyhole) are rotated until aligned with each other to orient the integrated locator / indicator tool 1405 in the appropriate flow direction of the implantable valve. At this time, the integrated locator / indicator tool 1405 is centered and oriented in the direction of flow of the implantable valve, and the current suggestion or valve setting is read and visually displayed on the LCD (FIG. 17E). If the current valve setting is to be changed or programmed to a new valve setting, then in FIG.17F, the adjustment tool 1415 is inserted into the cavity 1420 of the integrated locator / indicator tool 1405 and the adjustment tool The reference marking 1619 on 1415 is rotated until it is aligned with the marking on the upper lens 1540 corresponding to the current valve setting read. In FIG. 17G, the adjustment tool 1415 is rotated clockwise / counterclockwise to the marking on the upper lens corresponding to the new valve setting. Once set to the new valve setting, in FIG.17H, the adjustment tool 1415 is removed from the integrated locator / indicator tool 1405 (while the integrated locator / indicator tool 1405 remains in place) and this New valve settings are automatically detected by the integrated locator / indicator tool 1405 and visually displayed on the LCD 1555 (see FIG. 17I). Note that the positioning of the integrated locator / indicator tool 1405 remains unchanged in steps 17E-17I. The improved electronic toolset eliminates the need or need to relocate the center of the valve and then verify the new valve settings after adjustment by adjustment tool 1415.

  As shown in FIG. 14, the electronic toolset of the present invention provides a latest version or latest generation of programmable having a fixed reference magnet 800 separately and in addition to a pair of primary magnets 123, 125 in the adjustable valve unit 100. Suitable for use with an implantable valve (see FIG. 1). As discussed above, a fixed reference magnet is used to determine the angular orientation of the valve. Other, possibly older, generations or versions of programmable implantable valves that do not use a reference magnet separate from and in addition to the pair of primary magnets in the adjustable valve unit may still be used. . In that case, the angular orientation of the valve cannot be ascertained using the electronic toolset. Of course, a generation or version of a programmable implantable valve that does not use a reference magnet will still have its corresponding older version or generation of toolsets (i.e., detect a fixed reference magnet and electronically determine an orientation angle based thereon. (Which are not configured in any way). However, this requires medical personnel to be able to use various versions or generations of electronic toolsets that correspond to either the presence or absence of a fixed reference magnet in the programmable implantable valve. Become. To select the appropriate generation or version of the toolset, the user must first identify which version or generation of the implantable programmable valve has been implanted. This can be achieved via X-ray imaging (e.g., identifying the presence or absence of a reference magnet), but such exposures have deleterious effects on health and should therefore be avoided whenever possible It is. Another disadvantage is that medical equipment requires a spatial allocation to store different versions or generations of toolsets. However, one of the overwhelming greatest associated risks is the potential for healthcare professionals to select and use a generation or version of the toolset that is incompatible with the implanted valve. These risks and drawbacks are that the universal electronic tool of the present invention can be used interchangeably with both programmable implantable valves using fixed reference magnets and earlier generations or versions of programmable implantable valves without fixed reference magnets. Reduced or overcome by using sets.

  Specifically, the locator / indicator tool 1405 of the present invention determines whether the fixed reference magnet 800 associated with the adjustable valve unit 100 is detected by a two-dimensional array of three-axis magnetoresistive sensors 1570. Circuit. If the fixed reference magnet 800 is not detected (i.e., is not present), the system sorts the magnets based on the history valve mechanism to facilitate guidance for locating the valve, but requires the user to provide electronic assistance or electronic feedback. It is necessary to judge the orientation by palpation or the like without using. As the user manually orients the toolset over the valve mechanism, the toolset provides suggestions for valve settings based on north / south pole angles and facilitates adjustment of valve settings.

  FIG. 18 shows the specific steps performed to determine whether the implanted valve 10 is of a generation or version with a fixed reference magnet 800 and the associated operating steps performed in each case. 5 is an exemplary flowchart of the above. Specifically, in step 2005, the presence of the fixed reference magnet 800 in the implanted valve 10 is confirmed using a two-dimensional array of three-axis magnetoresistive sensors 1570 in an integrated locator / indicator tool 1405. You. If the fixed reference magnet 800 in the implanted valve 10 is detected in step 2010, then in step 2015 the center of the adjustable valve unit 100 is located. Specifically, the localization of the center of the adjustable valve unit 100 is first associated with the adjustable valve unit 100 using a two-dimensional array of three-axis magnetoresistive sensors 1570 in the integrated locator / indicator tool 1405. This is realized by detecting the primary magnets 123 and 125. When the primary magnets 123, 125 are detected, the center of the adjustable valve unit 100 is located midway between the primary magnets 123, 125 to indicate the center of the adjustable valve unit 100. Next, at step 2020, the flow direction of the valve is determined based on the located center of the adjustable valve unit 100 (at step 2015) and based on the detected fixed reference magnet 800 (at step 2005). . The integrated locator / indicator tool 1405 is moved until it is aligned with the specified center of the adjustable valve unit 100, and then the tool is rotated to the appropriate orientation aligned with the specified flow direction of the valve . Preferably, this is indicated by two separate icons, one is a fixed valve position icon indicating an implanted valve and one is a movable locator / indicator tool icon indicating an integrated locator / indicator tool 1405 Is realized visually on the display screen 1555 to be displayed. Note that a single icon, hereinafter referred to as a "dual parameter icon", can be used to indicate more than one parameter (eg, centering and flow direction). For example, the dual parameter icon may be an outer circle having a keyhole shape within the outer circle that is complementary to the contour of the programmable shunt valve device 10 of FIG. In this example dual parameter icon, the outer circle corresponds to the centering parameter, but the keyhole shape within the outer circle indicates the flow direction parameter. The integrated locator / indicator tool 1405 keeps the two icons visible on the display screen 1555 aligned until both icons are aligned for both the center of the valve (outer circle alignment) and the flow direction (keyhole shape). Moved and rotated appropriately. At this time, since the integrated locator / indicator tool 1405 is properly aligned and the orientation angle is aligned with the flow direction of the valve, operation proceeds to step 2025, where an indication of the current valve setting is provided by the primary magnets 123, 125 Read by integrated locator / indicator tool 1405 based on the north / south magnetic pole angle of the sensor to help adjust valve settings as desired.

  If the new electronic toolset will be used with an earlier generation or version of an implanted valve that does not use a fixed reference magnet, then in step 2010 the presence of such a fixed reference magnet will Not detected by the two-dimensional array of sensors 1570. The process proceeds to step 2030, where the center of the adjustable valve unit 100 is located similarly to the process discussed above in connection with step 2015. Specifically, localization of the center of the adjustable valve unit 100 is first associated with the adjustable valve unit 100 using a two-dimensional array of three-axis magnetoresistive sensors 1570 in an integrated locator / indicator tool 1405. This is realized by detecting the primary magnets 123 and 125. When the primary magnets 123, 125 are detected, the center of the adjustable valve unit 100 is located midway between the primary magnets 123, 125. The integrated locator / indicator tool 1405 is moved until it is aligned with the specified center of the adjustable valve unit 100. Again, preferably, this is two separate icons (one is a fixed valve position icon indicating an implanted valve and one is a movable locator / indicator tool icon indicating an integrated locator / indicator tool 1405). Is visually realized on the display screen 1555 on which is displayed. When the presence of the fixed reference magnet is not detected, the icon to be displayed (for example, only the outer circle) represents a single parameter (for example, centering). There is no keyhole shape in the outer circle indicating the flow direction parameter. This is because such parameters are not electronically detectable in the absence of the fixed reference magnet 800 using the assistance and feedback of the integrated locator / indicator tool 1405. The integrated locator / indicator tool 1405 is moved appropriately until the two icons visible on the display screen 1555 are aligned with respect to the center (alignment of the outer circle). Instead, because the fixed reference magnet is not detected, and thus no electronic assistance or electronic feedback information regarding the flow direction line of the implanted valve is provided by the integrated locator / indicator tool 1405, the operator may instead adjust Is notified that the center and flow direction, i.e., the orientation angle, must be determined manually without using electronic assistance or electronic feedback information from any tool in the electronic toolset. Via one or more sensations, including, and / or tactilely). Preferably, the user does not use the electronic assistance or electronic feedback information provided by the electronic toolset to provide a method of manually orienting the toolset over the implanted valve, i.e., the center of the implanted valve. The method for manually determining the flow direction (step 2035) is guided step by step. According to an example based on the configuration of the adjustable valve unit 100 shown, the user may be instructed to palpate the area of interest until the adjustable valve unit 100 is located, then the center is marked. (Ie the rigid part of the valve distal to the reservoir). In addition, the positions of the inlet connector barb and the outlet connector barb of each catheter can be determined by palpation and corresponding marking. The straight line passing through the three markings then represents the flow direction line. When the flow direction line is manually identified (without using electronic assistance or electronic feedback information from any tool in the electronic toolset), the integrated locator / indicator tool 1405 will align with the flow direction line. Orientated manually. Here, the center of the adjustable valve unit 100 is located and the integrated locator / indicator tool 1405 is manually aligned to the manually detected orientation of the implanted valve in the flow direction. The operation proceeds to step 2040 where an indication of the current valve setting is read by the integrated locator / indicator tool 1405 based on the north / south magnetic pole angles of the primary magnets 123, 125, and the Adjustment is facilitated. As described above, when using other valve configurations, the steps for locating the center and flow direction of the valve differ from those described above by using other fixed reference points on the valve. Is also good.

  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.

10 Programmable shunt valve device, programmable shunt valve, implanted valve
12 Shunt housing, housing
14 Proximal connector
16 distal connector
18 Sampling or pump chamber
20 Needle guard
22 Backing plate
30 passages
100 Adjustable valve units, valve units
102 entrance
103 Casing
104 Upper casing
106 Lower casing
120 rotor
120a monolithic rotor
122 Lower cam structure, lower cam section, cam part
123 magnet element, primary magnet element, primary magnet, magnet
124 Upper magnet housing, housing, rotor housing, housing part
125 magnet element, primary magnet element, primary magnet, magnet
126 rotor axle, axle
127 fingers
129 Tantalum ball, Tantalum reference ball
130 Spring arm unit
132 Rigid cam 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, downward protruding rotor teeth
161 Lower surface
162 downward protruding teeth, rotor teeth, downward protruding rotor teeth, rotor housing teeth
163 Facet
170 Casing lock stopper, lock stopper, casing stopper
171 Setting pocket, mounting pocket
172 Casing lock stopper, lock stopper
174 Casing lock stopper, lock stopper, casing stopper
176 Casing lock stopper, lock stopper, casing stopper
180 limiter
182 gasket
190 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
1408 Spare battery
1410 screwdriver
1415 Adjustment Tool
1420 cavity
1500 housing
1505 Lower housing section
1510 Intermediate housing section
1515 Upper housing section
1520 recess
1525 Chimney
1530 cylindrical section
1535 channels
1540 Top layer, top cover, top lens
1542 opening
1550 2nd opening
1555 LCD display, display screen
1560 power 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
1619 Standard marking
1620 Magnet assembly
1625 Cylindrical spacer
1630 semicircular magnet, magnet
1635 semicircular magnet, magnet
1640 Shield magnet, magnet
1650 York
1655 vertical ribs, recesses

Claims (8)

Indicating and adjusting the implantable programmable fluid drainage valve, whether or not the implantable programmable fluid drainage valve comprises a fixed reference magnet used to determine the orientation angle of the implantable programmable fluid drainage valve A method for using a universal electronic toolset for an implantable body fluid drainage valve, comprising: an adjustable valve unit having a pair of primary magnet elements.
Detecting whether the fixed reference magnet is present in the implantable programmable fluid drainage valve using a magnetic field detection sensor array in an indicator tool of the electronic tool set;
If the presence of the fixed reference magnet in the implantable bodily fluid drainage valve is detected,
Locating the center of the adjustable valve unit using the indicator tool of the electronic tool set;
Determining the flow direction of the adjustable valve unit based solely on electronic feedback provided by the indicator tool of the electronic tool set without the need for manual body palpation;
Aligning the indicator tool of the electronic tool set with the located center of the adjustable valve unit and the flow direction;
Reading a current valve setting using the indicator tool of the electronic toolset.
If the presence of the fixed reference magnet in the implantable programmable bodily fluid drainage valve is not detected,
Locating the center of the adjustable valve unit using the indicator tool of the electronic tool set;
Establishing the flow direction of the adjustable valve unit only by manual body palpation without using electronic feedback from the indicator tool of the electronic tool set;
Aligning the indicator tool of the electronic tool set with the located center of the adjustable valve unit and the flow direction;
Reading the current valve setting using the indicator tool of the electronic tool set. Each of the two steps of locating
Detecting a magnetic field pattern generated by each of the pair of primary magnet elements using the magnetic field detection sensor array;
Finding an intermediate point between said detected pair of primary magnet elements that is indicative of said center of said adjustable valve unit.   The flow direction of the adjustable valve unit in the step of confirming includes: (i) a mark indicating a fluid flow direction through the implantable bodily fluid drainage valve; and (ii) the mark between the detected pair of primary magnet elements. The method of claim 1, wherein the method indicates a found midpoint and (iii) a reference line intersecting the detected fixed reference magnet.   The method of claim 1, wherein establishing comprises locating the center and flow direction of the adjustable valve unit only by manual body palpation of the area of interest. An implantable programmable body fluid drainage valve having an adjustable valve unit with a pair of primary magnet elements, wherein the pair of primary magnet elements is for programming the implantable programmable body fluid drainage valve to a desired valve setting. An implantable programmable fluid drainage valve,
A universal electronic toolset for indicating and adjusting the implantable programmable fluid drainage valve, comprising:
(i) an indicator tool having a magnetic field detection sensor array to detect the pair of primary magnet elements, and (ii) determine the presence or absence of a fixed reference magnet in the implantable programmable bodily fluid drainage valve; and A circuit for determining the center of the adjustable valve unit based on the pair of primary magnet elements provided, wherein the circuit only includes electronic feedback from the tool set when the fixed reference magnet is present. Determining the angular orientation of the implantable programmable fluid drainage valve, wherein the circuit determines the angular orientation of the implantable programmable fluid drainage valve only by manual palpation of the body when the fixed reference magnet is absent. The step of disposing of the implantable programmable fluid drainage valve. Generated on a play, and a circuit, and a general-purpose electronic tools set, implantable programmable fluid drainage valve system.   6. The system of claim 5, wherein the angular orientation is a direction of fluid flow through the implantable programmable fluid drainage valve. The circuit is
Using the magnetic field detection sensor array to detect a magnetic field pattern generated by each of the pair of primary magnet elements;
6. The system of claim 5, wherein the center of the adjustable valve unit is determined by finding an intermediate point between the detected pair of primary magnet elements that indicates the center of the adjustable valve unit.   If the fixed reference magnet is detected as being present, the circuit will only (i) indicate the direction of fluid flow through the implantable bodily fluid drainage valve by the electronic feedback from the tool set alone; ii) the angle of the implantable programmable bodily fluid drainage valve indicating the found intermediate point between the detected pair of primary magnet elements and (iii) a reference line intersecting the detected fixed reference magnet. The system of claim 7, wherein the system determines an orientation.