JP7226887B2 - An electronic toolset for locating, reading, adjusting, and confirming adjustments of an implantable fluid drainage system without post-adjustment recalibration - Google Patents

Description

The present invention relates to systems and methods for implantable drainage valves for drainage of bodily fluids (eg, cerebrospinal fluid). In particular, the systems and methods of the present invention provide for locating, reading, and adjusting adjustments of an implantable fluid drainage system without the need for the user to remove the toolset from the patient to recalibrate/re-zero after the adjustment. , adjustment, and verification.

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

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

Some implantable valves are fixed pressure valves (ie, monopressure valves) and others have adjustable or programmable settings. A programmable or adjustable implantable valve is desirable in that the valve pressure setting can be non-invasively changed via an external control device over the course of treatment without the need for an explant. One such conventional adjustable or programmable implantable valve using magnets is assigned to DePuy Orthopedics, a J&J company associated with the present assignee, and is incorporated herein by reference in its entirety. CODMAN® HAKIM® Programmable Valve (CHPV), as disclosed in US Pat. No. 4,595,390. Another programmable implantable drainage valve is CODMAN CERTAS, as disclosed in U.S. Pat. No. 8,322,365, also assigned to DePuy Orthopedics, J&J company, related to the present assignee and incorporated herein by reference in its entirety. (Registered Trademark) Programmable Valve. Medtronic also has a programmable implantable shunt valve Strata® controlled using magnets, disclosed in US Pat. No. 7,856,987 and incorporated herein by reference in its entirety. Each of these conventional programmable valves includes at least one magnetic element for adjusting the valve setting. Specifically, these conventional programmable implantable valves locate and read the current valve setting based on measurements of the magnetic field produced by the magnets within the valve, and change the current valve setting to the new valve setting. It can be controlled non-invasively after implantation using an electronic toolset that is capable of adjusting valve settings and confirming new valve settings that have been adjusted. The electronic toolset will vary with the particular programmable implantable valve, but typically the electronic toolset will include a locator tool for determining the center of the implanted valve, as well as reading the current valve settings, An indicator tool for confirming the adjusted new valve setting and an adjustment tool for changing the valve setting from the current valve setting to the adjusted new valve setting.

The adjustment tool used to change the valve setting is one of sufficient strength to rotate the magnet associated with the rotating structure within the adjustable valve unit of the programmable implantable valve to the desired valve setting. or comprising a plurality of magnetic elements (eg magnets or electromagnet coils). Due to the strength of this magnetic element, the residual magnetic field after use of the adjustment tool can result in overloading of the sensor, thereby requiring the sensor to be reset, or it can be detrimental to the operation of other tools in the electronic toolset. Residual magnetism, which has deleterious effects, can lead to the possibility of inaccurate reading of the center position, orientation angle, and/or valve setting (e.g., current or adjusted new valve setting) of the implantable valve. . Such negative effects of the external magnetic field generated by the magnet components in the adjustment tool on the components in the locator/indicator may cause medical personnel to move away from the implanted valve after adjusting the valve setting using the adjustment tool. , re-zero the device relative to the environment, relocate the center and orientation of the implantable valve, and then read the new valve setting to ensure that the valve setting matches the desired valve setting. (This is a procedure that must be performed with the Medtronic Strata Varius® programmable valve). These additional steps extend procedure time and increase the risk of human error that can affect proper confirmation of changes in valve settings.

U.S. Patent No. 4,595,390 U.S. Patent No. 8,322,365 U.S. Patent No. 7,856,987

Thus, an improvement used to locate, read, adjust, and verify successful adjustment in an implantable fluid drainage system that eliminates the need to re-zero/recalibrate after adjusting to a new valve setting. It would be desirable to develop a well-designed electronic toolset.

One aspect of the present invention is to locate, read, adjust, and verify successful adjustment in an implantable fluid drainage system that eliminates the need to re-zero/recalibrate after adjusting to a new valve setting. to an improved electronic toolset for use in

Another aspect of the invention relates to a method of using an electronic toolset to locate, read, adjust, and verify adjustments of an implantable fluid drainage system without the need for post-adjustment recalibration. . An implantable fluid drainage system includes an implantable fluid drainage valve having an adjustable valve unit. The adjustable valve unit is adjusted from the current valve setting to the new valve setting using an adjustment tool in the electronic toolset, the adjustment tool having at least one magnetic element and an indicator in the electronic toolset. A tool reads or verifies the current valve settings using the sensor array. The method of the present invention eliminates the need to remove the electronic toolset from the patient to recalibrate or zero the sensor array prior to confirming the new valve setting adjusted in the adjusting step.

In another aspect of the invention, the indicator tool has a magnetic permeability μz of about It comprises ferromagnetic system components disposed within a magnetically shielded cage made from a metal alloy having a magnetic flux of 1.0×10 ⁻⁴ or greater.

Yet another aspect of the present invention is an electronic toolset for locating, reading, adjusting, and confirming adjustments of an implantable fluid drainage system without the need for post-adjustment recalibration, comprising: A possible fluid drainage system relates to an electronic toolset comprising an implantable fluid drainage valve with an adjustable valve unit. The electronic toolset comprises an adjustment tool having at least one magnetic element for adjusting the adjustable valve unit from the current valve setting to the new valve setting. In addition, the electronic toolset includes an indicator tool for reading current valve settings or confirming new valve settings using the sensor array. The indicator tool has a magnetic permeability μ(H/m) of approximately 1.26×10 ⁻⁴ or greater to prevent residual magnetic fields generated by at least one magnet element within the adjustment tool from affecting the sensor array. ferromagnetic system components disposed within a magnetically shielded cage made from a metal alloy comprising:

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

1 is a schematic exploded perspective view of a programmable valve device having an adjustable valve unit; FIG. 2 is an exploded perspective view of the adjustable valve unit of FIG. 1; FIG. 3 is a top view of the adjustable valve unit of FIG. 2; FIG. Figure 4 is a side cross-sectional view of the adjustable valve unit of Figure 3 along line 4-4; 5 is a cross-sectional view of the adjustable valve unit of FIG. 3 along line 5-5; FIG. Figure 6 is a partial cross-sectional view of the adjustable valve unit of Figure 4 taken generally along line 6-6 at a first pressure setting; 6A is a deeper cross-sectional view of the adjustable valve unit of FIG. 4 generally along line 6A-6A at the first pressure setting; FIG. 5 is a partial cross-sectional view of the adjustable valve unit of FIG. 4 at one of various series of pressure settings; FIG. 5 is a partial cross-sectional view of the adjustable valve unit of FIG. 4 at one of various series of pressure settings; FIG. 5 is a partial cross-sectional view of the adjustable valve unit of FIG. 4 at one of various series of pressure settings; FIG. 5 is a partial cross-sectional view of the adjustable valve unit of FIG. 4 at one of various series of pressure settings; FIG. 5 is a partial cross-sectional view of the adjustable valve unit of FIG. 4 at one of various series of pressure settings; FIG. 5 is a partial cross-sectional view of the adjustable valve unit of FIG. 4 at one of various series of pressure settings; FIG. 5 is a partial cross-sectional view of the adjustable valve unit of FIG. 4 at one of various series of pressure settings; FIG. 7 is a deeper cross-sectional view of the adjustable valve unit of FIG. 4 taken generally along line 7-7; FIG. FIG. 8 is a cross-sectional view of the adjustable valve unit of FIG. 7 showing transitions to different pressure settings; FIG. 10 is a perspective view of a spring arm unit with optional torsion springs; FIG. 10 is a top plan view of the elements of FIG. 9; 10 is a side cross-sectional view of the adjustable valve unit of FIG. 8 taken along line 10-10 showing axial elevation of the rotatable structure; FIG. 6H is a shallower partial top cross-sectional view of the adjustable valve unit of FIG. 6H showing the "substantially OFF" position in an unrestrained condition; FIG. 12 is a side view along line 12-12 of FIG. 11; FIG. 13 is a side cross-sectional view along line 13-13 of FIG. 11; FIG. 13A is a partial cross-sectional view taken along line 13A-13A of FIG. 13; FIG. 1 is a perspective view of an electronic tool set comprising an integrated locator/indicator tool, adjustment tool, and screwdriver according to the present invention; 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 within the integrated locator/indicator tool; FIG. 15 is an exploded view of the integrated locator/indicator tool of FIG. 14; FIG. Figure 15 is an exploded view of the adjustment tool of Figure 14; 15 is a perspective view showing the placement of semi-circular magnets on either side of the shield magnet comprising part of the magnet assembly of FIG. 14; FIG. 15 is a perspective view of the assembled magnet assembly of FIG. 14; FIG. 15 is a top view of the assembled lower and middle housing sections of the adjustment tool of FIG. 14 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. 15 is an exploded view of the battery door assembly from the assembled integrated locator/indicator tool of FIG. 14; FIG. 17 is a cross-sectional view of the integrated locator/indicator tool of FIG. 17 along line 17-17; FIG. FIG. 10 is a front view of the battery door assembly of the integrated locator/indicator tool; FIG. 4 is a top view of the battery tray and upper magnetic shield cage section; 17D is a bottom view of the battery tray and upper magnetic shield cage section of FIG. 17C; FIG. Fig. 3 shows one of a series of steps for operating an electronic toolset according to the invention; Fig. 3 shows one of a series of steps for operating an electronic toolset according to the invention; Fig. 3 shows one of a series of steps for operating an electronic toolset according to the invention; Fig. 3 shows one of a series of steps for operating an electronic toolset according to the invention; Fig. 3 shows one of a series of steps for operating an electronic toolset according to the invention; Fig. 3 shows one of a series of steps for operating an electronic toolset according to the invention; Fig. 3 shows one of a series of steps for operating an electronic toolset according to the invention; Fig. 3 shows one of a series of steps for operating an electronic toolset according to the invention; Fig. 3 shows one of a series of steps for operating an electronic toolset according to the invention;

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

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

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

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

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

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

Valve unit 100 is shown assembled in FIGS. 3-5 and positioned at a second pressure setting as described in more detail below. Rotor housing 124 carries downwardly projecting teeth 160 and 162 that cooperate with four locking stops that project upwardly from lower casing 106 in this configuration. Lock stop 172 is shown in partial cross-section in FIG. 4, and lock stops 170 and 176 are visible in FIG. Preferably, the lower surfaces of rotor teeth 160 and 162 are circular, and the upper surfaces of casing lock stops 170, 172, 174, and 176, respectively, are chisel-like lead-in shapes to assist in returning the rotor teeth to the restrained position. having a plurality of facets to form a However, the vertical surfaces of teeth 160, 162 and stops 170-176 abut when engaged and do not "draw out", ie, prevent relative translational movement. Pure vertical lift to overcome tooth-stop abutment and change performance settings must be achieved by an adjustment tool as described in more detail below.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

FIG. 14 is a perspective view of an electronic tool set 1400 of the present invention stored within a case. The toolset includes an integrated locator/indicator tool 1405 , an adjustment tool 1415 and a screwdriver 1410 . Although the toolset of FIG. 14 includes an integrated locator/indicator tool 1405, the present invention provides that none of the tools are integrated into a single device, some are integrated into a single device, or all are integrated into a single device. It is applicable for toolsets that are integrated into a single device. 14A shows a top perspective view of integrated locator/indicator tool 1405 and adjustment tool 1415 of FIG. 14B shows adjustment tool 1415 after insertion into cavity 1420. FIG.

15 is an exploded perspective view of the integrated locator/indicator tool 1405 of FIG. 14 with housing 1500. FIG. In the illustrated example, housing 1500 includes a lower housing section 1505, a middle housing section 1510, and an upper housing section 1515, each spaced apart from each other. Cylindrical section 1530 of intermediate housing section 1510 defines a passageway or channel 1535 extending longitudinally therethrough. Upper housing section 1515 has a chimney 1525 complementary in size and shape to be received within passage or channel 1535 of cylindrical section 1530 of middle housing section 1510 . Chimney 1525 is closed at one end and open at the opposite end. An open end of chimney 1525 that receives adjustment tool 1415 therein, as will be described in greater detail below. The outer surface of lower housing section 1505 defines a recess 1520 therein that is complementary in shape and size to the outer contour of the programmable implantable fluid drainage valve. In use, the integrated locator/indicator tool 1405 is positioned with the outer surface of the lower housing section 1505 against the patient's skin and the implantable fluid drainage valve seated within the recess 1520 . A top cover or top layer 1540 may be attached to the top of the assembled housing. Such a cover or layer 1540 has an opening 1542 of complementary size and shape to chimney 1525 . Disposed around the perimeter of opening 1542 is a series of markings representing the individual valve settings in predetermined increments (eg 1, 2, 3, 5, 6, 7, 8). A second opening 1550 in the top cover or top layer 1540 allows a display 1555, such as a liquid crystal display (LCD), to be viewed therethrough. Integrated locator/indicator tool 1405 is powered by one or more batteries and is turned ON/OFF by button 1560 . The batteries are housed in a battery enclosure assembly 1565 that comprises a tray with electronic contacts between which the batteries are inserted. Access to battery enclosure assembly 1565 for insertion/removal of batteries from battery enclosure assembly 1565 is through removable battery door assembly 1575 . A two-dimensional array of three-axis magnetoresistive sensors 1570 printed on the circuit board detects the magnetic field pattern produced by the magnet elements 123, 125 and the fixed reference magnet 800 disposed within the housing 124 of the rotor 120. . It is within the intended scope of the present invention to substitute the triaxial magnetoresistive sensor 1570 with other types of sensor arrays capable of detecting magnetic fields, such as Hall sensors. A printed circuit board 1573 contains controller circuitry for controlling the integrated locator/indicator tool 1405 . In contrast to conventional toolsets, the integrated locator/indicator tool 1405 of the toolset 1400 of the present invention does not have openings to allow the user to manually palpate the valve. Instead, all feedback for locating valve center and orientation angle is provided electronically on display 1555 . This configuration (which does not require an opening or hole in the middle of the sensor array for the user to palpate the valve) is advantageous in terms of protection against "closed" sensor arrays. If such an aperture or hole were required in the middle of the sensor array, the sensor array configuration of the present invention would be significantly more complex, if not impossible.

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

The semi-circular magnets 1630, 1635 in the adjustment tool for changing or adjusting the valve setting rotate the magnets 123, 125 associated with the rotary structure 120 in the adjustable valve unit 100 to the desired valve setting. It is a relatively high strength magnet sufficient for These magnets 1630 , 1635 can overload the magnetoresistive sensor array 1570 in the locator/indicator tool 1405 after insertion of the adjustment tool 1415 . Additionally, the magnets 1630, 1635 within the adjustment tool 1415 induce magnetic fields within the ferromagnetic system components (e.g., batteries) of the locator/indicator tool 1405 such that the adjuster tool is removed after removal of the external magnetic field (after programming the valve). magnetization) or residual magnetization (ie, remanent magnetism left in ferromagnetic materials such as iron). Residual magnetism in the battery of the locator/indicator tool 1405 has an undesirable effect on the magnetoresistive sensor array 1570 resulting in improper detection of the valve magnets 123, 125 and the fixed reference magnet 800 in the adjustable valve unit 100. can give rise to Previously, to compensate for such undesirable effects of the magnetic field generated by the magnets 1630, 1635 within the adjustment tool 1415, the adjustment tool 1415 was removed and the indicator tool 1405 was removed after adjustment of the valve setting. It had to be moved far enough away from the valve to recalibrate, erase, or zero. After recalibration, the position of the center of the valve had to be relocated using the locator tool 1405 and then read to confirm the suggestion or valve setting. Of course, if the valve setting is actually changed (i.e., by the magnetic field generated by the magnets 1630, 1635 associated with the adjustment tool 1415), then the valve can be adjusted accurately using the adjustment tool 1415. must be programmed to the correct valve setting. These safety precautions are often redundant by involving the same steps that must be performed again and again on a periodic basis, which consumes valuable time of medical personnel, and therefore users It does not always follow, and of course increases the possibility of human error with each additional step required.

Current toolsets using analog compass systems are one factor limiting adoption of programmable valve systems along with associated electronic toolsets that require recalibration prior to verification of valve settings after adjustment. does not require user recalibration and repositioning of the valve after adjustment of . Note that the problem of overloading the magnetoresistive sensor array 1570 can be avoided by choosing suitable sensors that do not need to be reset after being overloaded with the conditioning tool. For example, a sensor with a resolution of less than about 0.5 μT is resistant to palming and can therefore be exposed to magnetic fields associated with adjustment tools without damaging the sensor. However, other problems caused by remanent magnetization induced in system components (eg, batteries) cannot be easily resolved simply by choosing different system components. This is because ferromagnetic batteries are not readily available off-the-shelf products. Customized batteries can be selected that are non-ferromagnetic to reduce the risk of residual magnetic fields, but the costs associated with such custom components are very high. Another possible solution is to simply move the ferromagnetic system components (eg batteries) that risk creating a residual magnetic field a greater distance away from the magnetoresistive sensor array. This solution is impractical due to the increased size of the tool, which significantly further increases the cumbersomeness of use.

The present invention provides that the ferromagnetic system components (e.g., batteries) within the integrated locator/indicator tool 1405 are fully or partially shielded from the magnetic field generated by the magnets 1630, 1635 within the adjustment tool 1415, thereby providing magnetic field sensing. A component (e.g., sensor array 1570) is fully or partially shielded from residual magnetic fields within ferromagnetic system components (e.g., batteries) surrounded by this shielding, thereby pre-checking post-adjustment valve performance settings. We are developing an improved toolset that eliminates the need to remove the locator/indicator tool 1405 from the patient in order to recalibrate, erase, or zero the sensor every time. It is therefore an object of the present invention to address the inadequacies in detecting the center of the valve and/or reading the valve setting and/or shielding the magnetic field sensing component 1570 from residual magnetic fields within ferromagnetic system components (e.g. batteries). To develop an improved electronic toolset that substantially mitigates, if not prevents, retention of magnetic charge by ferromagnetic system components (e.g., batteries) that undesirably affect sensor arrays that result in undesired operation. is. This is a permalloy (containing about 80% nickel and about 20% iron inclusions), specifically MuMetal grade ASTM A753 Alloy 4, a nickel-iron alloy with very high permeability that varies with grade and thickness. Place ferromagnetic system components (e.g., batteries) in a magnetically shielded cage, such as a soft ferromagnetic alloy, with relatively very high magnetic permeability (greater than about 1.0×10 ⁻⁴ at μz, peak flux density of 4 mT). Accomplished by enclosing, enclosing, or covering. A very high magnetic susceptibility (e.g., about 0.76 T) with respect to the applied magnetic field, such that it readily undergoes a magnetic field flow to reorient the magnetic field lines away from areas where it is desired that there be substantially no magnetic field. Other magnetic shielding alloys having a saturation level of Additional layers of shielding may be applied with varying levels of permeability/susceptibility depending on the frequency and strength of the magnetic field to be shielded. Intuitively, magnetic shielding alloys can be used to protect the sensor array and reduce the effects of external magnetic fields or the effects of insertion of the adjustment tool. However, magnetic shielding may not completely surround the sensor array, or otherwise shield the magnetic field of the implanted valve system, resulting in poor positioning of the implanted valve by the device. impede identification. Additionally, by enclosing the sensor array within a magnetic shield, intentional permeation of the magnetic field generated by the adjustment tool into the implanted valve for adjustment of the valve setting is restricted or otherwise prevented. is completely blocked. Thus, by limiting the magnetic shield to enclosing only the portion of the sensor array necessary to maintain proper operation of the conditioning tool, the shielding effectiveness is limited, thereby defeating its intended purpose. However, the configuration of the present invention provides a sensor array that allows visualization of the implanted valve magnets 123, 125 while allowing for temporary impact of the adjustment tool while it is inserted within the cavity of the adjustment tool. is counter-intuitive in approach, as it prevents overloading of the , but significantly reduces or eliminates the propagation of residual magnetic fields from shielded ferromagnetic system components (eg, batteries). A constant magnetic field in the vicinity of the sensor array can be zeroed by a one-time calibration or zero reset at start-up. However, when the adjustment tool 1415 is inserted into the adjustment tool cavity 1420 of the integrated locator/indicator tool 1405, the residual magnetic field within the battery changes based on the programmed/programmed valve settings of the adjustment tool magnets 1630, 1635. It changes dynamically based on the magnetic field.

17 is an exploded view of the battery door assembly 1575 of the integrated locator/indicator tool 1405. FIG. Preferably, the integrated locator/indicator tool 1405 is powered by batteries, most preferably off-the-shelf (non-customized) batteries such as two CR123 lithium batteries 1705 . Battery door assembly 1575 is removable, eg, slidable, within complementary tracks defined in outer housing section 1510 . Batteries 1705 are received in a battery tray 1710 with appropriate electrical contacts. As described above, the batteries 1705 in the battery tray 1710 are enclosed within a magnetically shielded cage. Thus, when assembled, the battery is completely enclosed or enclosed within a magnetically shielded cage everywhere except where wiring of the battery terminals to the controller circuit printed circuit board 1573 is required. Alternatively, partial shielding (eg, less than full or total encapsulation) of the cell within a magnetically shielded cage is also contemplated. 17A is a cross-sectional view of integrated locator/indicator tool 1405 along line 17-17 of FIG. In this cross-sectional view, a magnetic shield cage surrounds battery 1705 . In FIG. 17A it can be seen that the magnetic shielding cage comprises a bottom magnetic shielding cage section 1715 and a top magnetic shielding cage section 1720 . The bottom magnetic shield cage section 1715 (see Figures 17C and 17D) comprises two flat sections 1715', 1715'' that are substantially perpendicular to each other. The upper magnetic shield cage section 1720 shown in FIG. 17B has an upper flat section that is bent or curved down along each longitudinal side parallel to the longitudinal axis of the cell. Both ends of the longitudinal sides of the upper magnetic shield cage section 1720 in the axial direction remain open. A battery tray 1710 with two terminal ends is attached to a bottom magnetic shield cage section 1715 between curved longitudinal sides (see FIGS. 17C and 17D). The battery tray 1710 has its planar surface in the longitudinal direction between the terminals substantially parallel to one of the planar sections 1715' while intersecting one side of the terminal end of the battery tray. oriented so as to be substantially parallel to the other planar section 1715''.

18A-18I are a sequence of steps in operating the improved electronic toolset of FIG. 14 according to the present invention. 18A, integrated locator/indicator tool 1405 is turned on by pressing power button 1560. In FIG. Holding the power button 1560 for a predetermined period of time, eg, about 3 seconds, calibrates/erases or zeroes the magnetic field of the integrated locator/indicator tool 1405 as shown in FIG. 18B. Such calibration may be performed after pressing another button after the expiration of a predetermined period of time during which the power button is held, or it may be automatically calibrated (the button must be pressed/held when the tool is turned on). no). 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 positioned in the lower housing section 1505 as shown in FIG. 18C. is received in a recess 1520 of complementary size and shape defined in the exterior surface of the . The integrated locator/indicator tool 1405 remains in place until the two circular visual images shown on the LCD display 1555 are aligned with each other to suggest that the center of the adjustable valve unit 100 has been located. Moved in a direction (as indicated by the four arrows, each pointing in a different direction). Concurrently with, or substantially subsequent to, locating the center of adjustable valve unit 100, in FIG. (keyhole-shaped) to the implantable valve are rotated until mutually aligned to orient the integrated locator/indicator tool 1405 in the proper flow direction of the implantable valve. . At this time, with the integrated locator/indicator tool 1405 centered and oriented in the flow direction of the implantable valve, the current suggestion or valve setting is loaded and visually displayed on the display (e.g., LCD) 1555. displayed (see Figure 18E). If the current valve setting is to be changed or reprogrammed to a new valve setting, then in FIG. 18F, adjustment tool 1415 is inserted into cavity 1420 of integrated locator/indicator tool 1405 to adjust Rotate until the fiducial markings on the tool 1415 are aligned with the markings on the top lens 1540 corresponding to the current device settings loaded. In FIG. 18G, adjustment tool 1415 is rotated until the marking on the top lens is aligned with the marking representing the new valve setting. Once set to the new valve setting, in FIG. 18H the adjustment tool 1415 is removed from the integrated locator/indicator tool 1405 (while the integrated locator/indicator tool 1405 remains stationary in place) and this The new valve setting is automatically detected by the integrated locator/indicator tool 1405 and visually displayed on the LCD 1555 (see Figure 18I). Note that the positioning of the integrated locator/indicator tool 1405 remains unchanged in steps 18E-18I. The improved electronic toolset eliminates the need or need to relocate the center of the valve and then confirm the new valve setting after adjustment by adjustment tool 1415 .

The improved toolset of the present invention for use in programming implantable valves has been described and shown as comprising an integrated locator/indicator tool. Any of the tools in the toolset in which the battery is disposed in a magnetically shielded cage, similar to those discussed in detail above, prevents the effects of residual magnetic fields on the sensor array present in the indicator tool. Some of the tools in the toolset where the battery is disposed in a magnetically shielded cage, similar to those discussed in detail above, do not prevent the effects of remanent magnetic fields on the sensor array present in the indicator tool. The effect of the remanent magnetic field is present in the indicator tool to prevent the effects of the residual magnetic field from reaching the sensor array, or all of the tools in the tool set in which the battery is disposed in a magnetically shielded cage similar to those discussed in detail above. is contemplated and included within the intended scope of the invention. Furthermore, although the invention has been shown and described for the purpose of enclosing a battery within a magnetic shield, it is equally suitable for other ferromagnetic system components.

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

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

10 programmable shunt valve device
12 Shunt housing
14 proximal connector
16 Distal connector
18 sampling chamber or pumping chamber
20 Needle guard
22 backing plate
30 Passage
100 adjustable valve unit, valve unit
102 Entrance
103 Casing
104 upper casing
106 lower casing
120 Rotor, rotating structure
120a monolithic rotor
122 lower cam structure, lower cam section, cam portion
123 Magnetic elements, magnets, valve magnets
124 upper magnet housing, housing, rotor housing, housing part
125 Magnetic elements, magnets, valve magnets
126 rotor axle, axle
127 fingers
129 Tantalum Ball, Tantalum Reference Ball
130 spring arm unit
132 rigid cam followers, cam followers
133 stiffening element
134 elastic spring elements, spring elements, springs, valve springs
136 upper axle
138 lower axle, axle
139 Lower Synthetic Ruby Bearing, Bearing
140 valve mechanism
142 valve seat
144 Movable valve member, valve member, valve ball, ball
150 rotor retaining spring, retaining spring, spring
160 downward protruding tooth, rotor tooth, tooth
162 downward protruding tooth, rotor tooth, tooth, rotor housing tooth
170 Casing lock stopper, lock stopper, casing stopper
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 second cam surface
194 locations
195 Third cam surface
196 locations
197 4th cam surface
198 places
199 5th cam surface
200 locations
201 6th cam surface
202 places
203 7th cam surface
204 places
205 outermost cam surface
206 places
210 first radial distance, distance
212 second radial distance
214 third radial distance
218 maximum radial distance, distance
221 1st leg
222 Aperture
223 Second Leg
230 magnifying pad
232 posts
233 Triangle Head
234 Rivet
235 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 fixed reference magnet
801 bumps, cavities, pockets or protrusions
1400 Toolset, Electronic Toolset
1405 Integrated Locator/Indicator Tool
1410 screwdriver
1415 Adjustment Tool
1420 Cavity, Adjustment Tool Cavity
1500 housing
1505 lower housing section
1510 intermediate housing section, outer housing section
1515 upper housing section
1520 concave
1525 Chimney
1530 cylindrical section
1535 channels
1540 top layer, top cover, top lens
1542 Aperture
1550 Second opening
1555 display, LCD display
1560 power button
1565 battery enclosure assembly
1570 3-axis magnetoresistive sensor, magnetoresistive sensor array, magnetic field sensing component
1573 printed circuit board, controller circuit printed circuit board
1575 Removable Battery Door Assembly, Battery Door Assembly
1600 housing
1610 outer housing section
1615 upper housing section
1620 magnet assembly
1625 cylindrical spacer
1630 semi-circular magnet, magnet, semi-circular magnet, adjustment tool magnet
1635 semi-circular magnets, magnets, semi-circular magnets, adjustment tool magnets
1640 shield magnet, magnet
1650 York
1655 vertical rib
1705 Battery
1710 battery tray
1715 bottom magnetically shielded cage section, flat section
1720 Upper Magnetic Shield Cage Section

Claims (9)

An electronic toolset for locating, reading, adjusting, and verifying adjustments of an implantable fluid drainage system without the need for post-adjustment recalibration, said implantable fluid drainage system being adjustable An electronic toolset comprising an implantable fluid drainage valve having a valve unit, comprising:
an adjustment tool having at least one magnetic element for adjusting the adjustable valve unit from a current valve setting to a new valve setting;
An indicator tool for reading the current valve setting or confirming a new valve setting using a sensor array, wherein a residual magnetic field generated by the at least one magnet element in the adjustment tool is detected by the sensor array. ferromagnetic system components disposed within a magnetically shielded cage made from a metal alloy having a magnetic permeability μ(H/m) of about 1.26×10 ⁻⁴ or higher to prevent the An electronic tool set, further comprising an indicator tool. The magnetic shield cage comprises a plurality of magnetic shield cage sections that when assembled form an enclosure around the ferromagnetic system components, the enclosure forming two closed-ended ends. The electronic toolset of clause 1 . 3. The electronic toolset of Claim 2 , wherein the plurality of magnetically shielded cage sections comprises a bottom magnetically shielded cage section and an upper magnetically shielded cage section. The bottom magnetic shield cage section comprises a first planar section and a second planar section substantially perpendicular to the first planar section, and the top magnetic shield cage section comprises: 4. The electronic toolset of claim 3 , comprising a substantially flat central section, wherein longitudinal sides of the substantially flat central section are bent in the same direction. The ferromagnetic system component is at least one battery receivable in a tray having electrical contacts disposed at each longitudinal terminal end of the bottom magnetic shield cage section. 5. The electronic toolset of claim 4 , wherein one terminal end of said tray faces said second planar section of said bottom magnetic shield cage section while attached to said first planar section. . 2. The electronic toolset of claim 1 , further comprising a locator tool for locating the center and/or orientation angle of the adjustable valve unit. 7. The electronic toolset of claim 6 , wherein at least two tools in the electronic toolset are integrated into a single device. The locator tool of the electronic toolset does not have an opening for manual palpation of the implantable fluid drainage valve, and any information regarding the center and/or orientation of the adjustable valve unit is provided via electronic feedback. Electronic toolset according to claim 6 provided. 2. The electronic toolset of claim 1 , wherein the metal alloy is permalloy with inclusions of about 80% nickel and about 20% iron.

Images