CATHETER AND SHUNT SYSTEM INCLUDING THE CATHETER
20170136221 ยท 2017-05-18
Assignee
Inventors
- David Mortimer Budgett (Auckland, NZ)
- Ellyce Francis Stehlin (Auckland, NZ)
- Andrew James Taberner (Auckland, NZ)
- Poul Michael Fonss NIELSEN (Auckland, NZ)
- Simon Charles Malpas (Auckland, NZ)
Cpc classification
A61M27/006
HUMAN NECESSITIES
A61M2205/3337
HUMAN NECESSITIES
International classification
Abstract
In one embodiment of the invention a catheter (203) comprises a body having at least one inlet aperture (21, 24), at least one outlet aperture (22, 25), and at least one passage (20, 23) between the at least one inlet aperture (21, 24) and the at least one outlet aperture (22, 25). The catheter (203) is provided with pumping means (32) for selectively pumping fluid from one of said apertures (21, 22, 24, 25) to another of said apertures (21, 22, 24, 25). Methods of operating such a catheter are also disclosed.
Claims
1. A catheter comprising a body containing a pumping means and having at least one inlet aperture, at least one outlet aperture, and at least one passage between the at least one inlet aperture and the pumping means, and at least one passage between the at least one outlet aperture; and the pumping means, for selectively and reversibly pumping fluid between and through the at least one inlet aperture and the at least one outlet aperture.
2. The catheter of claim 1 wherein the catheter is provided with a plurality of inlet apertures independently connected to the pumping means.
3. The catheter of claim 1 wherein the catheter is provided with a plurality of outlet apertures independently connected to the pumping means.
4. The catheter of claim 3 wherein the pumping means is operable to pump fluid from any one of said inlet apertures to any one of said outlet apertures, and further wherein the pumping means is operable to pump fluid from any one of said outlet apertures to any one of said inlet apertures.
5. The catheter of claim 4 wherein catheter comprises a controller which operates the pumping means to flush an aperture on a periodic basis.
6. The catheter of claim 5 wherein the controller operates the pumping means to unblock any aperture by reversing the direction of fluid flow.
7. (canceled)
8. The catheter of claim 1 wherein the pumping means comprises at least one actuator operable to compress or dilate a resiliently flexible portion of the body of the catheter.
9. The catheter of claim 8 wherein the pumping means is operable to create a negative pressure in the at least one passage between the at least one inlet aperture and the pumping means, or in the at least one passage between the at least one outlet and the pumping means, compared to a pressure at any of the at least one inlet aperture and the at least one outlet aperture.
10. The catheter of claim 8 wherein the pumping means comprises a plurality of said actuators, each said actuator associated with a respective resiliently flexible portion.
11. The catheter of claim 1 wherein the pumping means is adapted to provide a required resistance to fluid flow through the passage when in a non-powered state.
12. The catheter of claim 1 wherein a pressure sensor is positioned inside the pumping means to allow selective measurement of pressure from sections of the catheter leading to specific apertures.
13. The catheter of claim 12 wherein the pressure sensor is calibrated by measurement from one aperture of known pressure and then an unknown pressure is derived from the measurement from another aperture.
14. The catheter of claim 12 wherein the catheter comprises a controller which controls the pumping action to flush an aperture based on feedback from the pressure sensor.
15-61. (canceled)
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0078] Preferred and alternative examples of the present invention are described in detail below with reference to the following drawings:
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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0091] The present invention pertains to catheters and shunt systems with the ability to avoid or remove proximal occlusions.
[0092] Referring first to
[0093] The valve housing may be made from a biocompatible material such as titanium or ceramics.
[0094] Referring in particular to
[0095] Referring next to
[0096] The secondary passage 10 is used to divert and store fluid from the main passage 6. The stored fluid can then be displaced in an opposing direction to the drainage fluid in the first passage 6. This alternate direction of flow prevents and removes blockages by periodically forcing occluding material in an opposing direction to normal fluid drainage.
[0097] A controller 11 for the secondary passage 10 may be contained in the catheter valve housing 8, close to the valve 7 which controls overall flow through the main passage 6 to the outlet 4. In one embodiment, the secondary passage 10 defines a reservoir 12 at its terminating end, which in one embodiment may be just proximal to the valve 7. Activation of the self flushing catheter system is achieved by compressing the reservoir 12, thereby forcing fluid towards the inlet aperture 2. In other embodiments (not shown) the second passage 10 may contain sufficient fluid that a distinct reservoir portion is not required. In such embodiments the second passage 10, or a portion of the second passage 10, may be deformed or compressed in order to displace the fluid therein back towards the inlet 2. This compression can be achieved using electrically actuated materials, as is described above with reference to the inlet 2, or through the use of one or more actuators, as described further below with reference to
[0098] The intersection between the first passage 6 and the second passage 10 also allows for refilling of the reservoir 12 with fluid from the inlet 2 and primary passage 6.
[0099] In another embodiment (not shown), the second passage 10 may have a second inlet which is independent from inlet 2.
[0100] In some embodiments the system 100 includes a miniature pressure sensor (not shown) that monitors pressure at the proximal end 3 of the catheter 200, 201. For example, in systems intended for use with hydrocephalus patients the sensor is positioned on the catheter such that it sits in the ventricle for a measure of true intracranial pressure. The pressure sensor data may be used as an indication of the effectiveness of the catheter 200, 201, allowing for an instant indication of the shunt's ability to control ICP in a hydrocephalus patient. Alternative locations for the pressure sensors include any of the shunt-valve housing 8 and distal end of the catheter 5.
[0101] Referring next to
[0102] Using the accelerometer 13 in conjunction with the pressure sensor, specific changes in intracranial pressure due to posture changes can be monitored, providing early evidence of any persisting occlusions. The accelerometer 13 is not required to sit in the catheter itself. In the embodiment shown in
[0103] Referring next to
[0104] In some embodiments, both shunt line resistance and occlusion prevention and debris removal will be achieved using the same mechanism. A shunt system provided with a catheter 202 as shown in
[0105] In a variation of the catheter shown in
[0106] Referring back to
[0107] The monitor/controller may include an algorithm to convert data received by sensor(s) in the implantable shunt system to instructions for the patient. A graphical user interface may be provided to display instructions and information on the status of the shunt system to the patient. The monitor/controller may contain an atmospheric reference pressure sensor.
[0108] In one embodiment the system 100 is only active when the external magnetic field producing power transfer means 16 is active and in range. The system 100 is therefore battery free and both the active occlusion resisting action and sensing system will cease activity when the external powering wand is removed. In another embodiment a super capacitor (not shown) can be used to allow for periodic activity of the active catheter. The super capacitor can be charged with holding the power transfer means 16 over the catheter control unit 11. When the power transfer means 16 is removed, the catheter remains active for some time.
[0109] Alternatively, the system includes a rechargeable battery (not shown) allowing continual activity when the external magnetic field supply is not applied. The battery supplies power to the device when the external wand is not being held over the system and continual monitoring of patient and catheter condition is realised. The battery is recharged when the external supply is in range.
[0110] In one embodiment telemetry is used to transmit data from the implanted active catheter's pressure sensor, accelerometer and/or other sensor(s). The information allows for
[0111] improvements in the control of an individual patient's catheter activity and for quick diagnosis of problems in the active catheter system. Pressure and accelerometer data therefore have the
[0112] ability to be used in closed control within the shunt system 100 itself or, alternatively the information is transmitted out of the active catheter system for external interpretation and use. The telemetry data may be received wirelessly by power transfer means 16.
[0113] Excluding the deformable proximal tip of the catheter, the bulk of the electronics are preferably contained in an encapsulated unit surrounding the catheter. In the hydrocephalus application, this unit may be situated alongside the shunt valve housing 8, or integrated into the valve housing 8. This allows the electronics to be located outside of the skull, providing the opportunity for close contact between inductively coupled coils 17, 18 for power transfer and wireless communication pickup.
[0114] Referring next to
[0115] A third passage 26 connects the first and second passages 20, 23.
[0116] The catheter is provided with a first actuator 27 between the proximal aperture 21 and the third passage 26, a second actuator 28 between the third passage 26 and the distal aperture 22, a third actuator 29 between the proximal aperture 24 and the third passage 26, and a fourth actuator 30 between the third passage 26 and the distal aperture 25. The third passage 26 is provided with a fifth actuator 31. Each actuator is connected to an adjacent resiliently deformable portion of the body.
[0117] In a preferred embodiment the electrical connection between the actuators and a suitable power source and/or control mechanism may be embedded into the catheter body.
[0118] Each of the actuators 27-31 is capable of compressing the adjacent portion of the body, and thereby restricting flow through the passage with which the actuator is associated. The compression of the body, and passage, has the effect of decreasing the internal volume of the passage.
[0119] The connection between the actuators 27-31 and the body is also such that the actuators can dilate the passage within the body, thereby increasing the internal volume of the passage, and thereby creating a negative pressure within the passage.
[0120] By correctly timing the opening and closing of the actuators 27-31, a pumping action can be achieved to draw fluid from any one of the apertures 21, 22, 24, 25 and deliver fluid to any aperture. Thus, the actuators 27-31, together with the portion of the passages on which the actuators act, define a pumping means, generally referenced by arrow 32.
[0121] In a normal or routine state, the pumping means draws fluid from either aperture 21 or 24 and delivers the fluid to either aperture 22 or 25 for the purpose of lowering ICP. However, it is also possible to direct flow in different directions to enable flushing of any aperture 21, 22, 24, 25, or any passage connecting an aperture to the pump 32.
[0122] By way of example, the operation of the pumping means 32 to pump fluid from aperture 21 to aperture 22 is described below.
[0123] The initial position of the pumping means 32 has actuator 28 in an open position, and all other actuators closed. The first step is to close the destination actuator 28. Next, the source actuator 27 is opened. Next, the crossover actuator 31 is opened, thereby drawing fluid through the source aperture 27.
[0124] The next step is to close the source actuator 27. Next, the destination actuator 28 is opened. Finally, the crossover actuator 31 is closed, expelling fluid through the destination aperture 28. This returns the system to the starting position, and another cycle may be initiated if required.
[0125] The pumping means 32 described above is preferably implemented with individually controlled actuators such as the SQL-RV-1.8 linear piezo electric motion control system available from New Scale Technologies. This motor has an I2C interface (also referred to as a two-wire interface) allowing direct connection to a nRF24LE1 system on chip, available from Nordic Semiconductor, which contains an 8051 microprocessor and 2.4 GHz radio transceiver.
[0126] In another embodiment, shown in
[0127] In a further embodiment (not shown), a pumping means may comprise a single linear actuator, such as a SQL-RV-1.8 linear piezo electric motion control system, which operates a cam, for example via a rhombic drive. The cam may implement the peristaltic pumping action.
[0128] Referring next to
[0129] The system control means (not shown) may use the algorithm to monitor (CP and reduce ICP pressure if it is too high. In a preferred embodiment the algorithm is implemented in a microprocessor.
[0130] The shunt system 101 comprises two proximal apertures 21, 24, which in use are located in the ventricle of the brain (not shown). A third aperture 22 is located at the distal end of the catheter.
[0131] At step 40 the ICP is measured by pressure sensor P1 and the system checks whether it exceeds a predetermined threshold pressure. If the ICP is elevated, a pumping means 32 is activated at step 41 to pump fluid from aperture 21 to aperture 22. The pumping means 32 is operated for a fixed duration and then stopped.
[0132] At step 42 the ICP is again measured. If it has dropped, the process loops back to step 40. If the ICP pressure does not drop after a pumping action, then at step 43 the system attempts to pump fluid from the second aperture 24. The ICP is again measured at step 44. If pumping from aperture 24 to aperture 22 is successful, as determined by a drop in the ICP, then it is assumed that aperture 21 is blocked and an attempt to remove the blockage in aperture 21 by back flushing fluid from aperture 22 or 24 is initiated at step 45, after which the process returns to step 40. If the ICP has not decreased at step 44, then it is concluded that the ICP cannot be managed, and an alarm is raised at step 46.
[0133] More detail of an algorithm for back flushing is described below with reference to
[0134] The algorithm shown in
[0135] Referring next to
[0136] The shunt system has two inlet apertures 21, 24. A pressure sensor P1 is located in the ventricle. A second pressure sensor P2 is located inside passage 20 running from aperture 21 to the pumping means 32. A third pressure sensor P3 is located in the second passage 23 running from aperture 24 to the pumping means 32.
[0137] The microprocessor implements two timers that decrement on a periodic basis, based on regular interrupts. The first timer is called the Pump Clean Timer. The Clean Pump Timer is reset at step 50. At step 51 the current value of the timer is monitored. When the Pump Clean Timer counts down to zero, the process of pumping fluid from one of apertures 21, 24 to aperture 22 is interrupted, and fluid is pumped from aperture 21 to aperture 24, or from aperture 24 to aperture 21. Thus, the algorithm of
[0138] The flushing process starts at step 52 by resetting the Pump Run Timer. At step 53 the pumping means 32 is run, with fluid entering aperture 21 and being pumped out of aperture 24. At step 54 the pressure measured in the ventricles by pressure sensor P1 is compared to the pressure measured in passage 20 by pressure sensor P2. If the pressure at P1 is greater than that at P2 by more than a threshold margin, for example 10%, then a blockage is indicated. If a blockage is detected, the pumping means 32 is stopped at step 55 and then reversed.
[0139] Otherwise, the pumping means continues to run until the Pump Run Timer reaches zero.
[0140] At step 56 the Pump Run Timer is reloaded. The pumping means 32 is then run to pump fluid from aperture 24 to aperture 21 at step 57. This process normally continues for a fixed time as determined by the number loaded into the Pump Run Timer, after which the entire process resets.
[0141] The reverse pumping action continues for a period defined by the Pump Run Timer unless a blockage is indicated by the pressure in passage 23 (measured by pressure sensor P3) exceeding P1 by more than a threshold margin, for example 10%, as shown at step 58. If a blockage condition is indicated, then at step 59 the pumping means 32 is stopped and at step 60 Pump Run Timer is again reset. At step 61 the pump direction is again reversed to attempt to remove the cause of the blockage.
[0142] If a blockage is again detected at step 62 then an alarm may be raised (not shown), or the system may make a note of the continued blockage and may raise an alarm if the blockage is still present after a predetermined number of unsuccessful cleaning cycles have been attempted.
[0143] After these processes are complete the pumping means is stopped at step 63. At step 64 the Pump Clean Timer is reloaded. This configures the delay before the next clean cycle begins.
[0144] By providing the catheter with a pumping means which can produce a negative pressure inside a catheter that is occluded, it is possible to clear a blockage by drawing the obstruction through the catheter.
[0145] Pressure sensors can be prone to long term drift where, over an extended period of time, the value they report differs from the actual pressure they experience. The embodiment shown in
[0146] An algorithm showing how the Reference Level is used for the purpose of managing
[0147] hydrocephalus is shown in
[0148] The derivation of the Reference Level may rely on recorded pressures from the distal aperture over a series of time intervals. This may be necessary to reduce artefacts that cause variation in the pressure at the location of the distal aperture. One example of the derivation is based on computing the mean pressure over a series of time intervals to use as a Reference Level.
[0149] Another example of the derivation is to record pressure values over a 24 hour period and find the silent interval where the pressure variation is less than 1 mm Hg. The mean pressure value calculated over samples during the longest silent interval occurring within the 24 hour period may then be then taken as the Reference Level. Another example of the derivation is to record the Reference Level in memory, and only allow it to be updated if the newly computed
[0150] Reference Level is within a fixed margin from the existing Reference Level. An example of the fixed margin is 0.5 mm Hg.
[0151] The shunt system shown in
[0152] The hydrocephalus algorithm shown in
[0153] independently from the pressure of the proximal aperture. The microprocessor is also capable of implementing more comprehensive processing to manage the flow of fluid based on all sensory information available and in combination with other algorithms already described, in addition to implementing diagnostic, maintenance and telemetry functions.
[0154] In some embodiments the pumping means of the shunt system may be positioned towards the distal end of the catheter, for example in the abdomen of the patient, allowing the proximal end to remain undisturbed if a revision is required.
[0155] In a preferred embodiment the system includes a pressure sensor signal conditioning arrangement which provides an analogue signal to an analog to digital converter located in the nRF24LE microprocessor. An Inductive Power section receives power from a magnetic field and maintains battery charge. Motors provide control and feedback to the actuators and communicate with the nRF24LE using the I2C serial protocol. The nRF24LE1 interfaces to a 50 ohm 2.4 GHZ antennae.
[0156] Use of the active catheter of the present invention is not limited to shunted hydrocephalus patients. It may also be used in a drug delivery system, where it is also advantageous to prolong the life of the catheter from occlusion failure.
[0157] Unless the context clearly requires otherwise, throughout the description and the claims, the words comprise, comprising, and the like, are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense, that is to say, in the sense of including, but not limited to.
[0158] Where in the foregoing description, reference has been made to specific components or integers of the invention having known equivalents, then such equivalents are herein incorporated as if individually set forth.
[0159] Although this invention has been described by way of example and with reference to possible embodiments thereof, it is to be understood that modifications or improvements may be made thereto without departing from the spirit or scope of the invention,
[0160] While the preferred embodiment of the invention has been illustrated and described, as noted above, many changes can be made without departing from the spirit and scope of the invention. Accordingly, the scope of the invention is not limited by the disclosure of the preferred embodiment. Instead, the invention should be determined entirely by reference to the claims that follow.