The present invention concerns the measurement of cerebrospinal fluid turbidity. The invention also concerns an associated system and method.
Devices for measurement of ambulatory intracranial pressure for patients with hydrocephalus and bearing a ventriculoperitoneal or ventriculoatrial shunt system and comprising a valve are known.
The surgery for implanting such a valve or revision of such a valve has high risks for the patient, for example infectious risks. Such surgery therefore constitutes a risky situation for the patient. An infection can actually result in meningitis. It is then necessary to remove the system from the patient. A powerful and long antibiotic treatment is then necessary before being able to reimplant a new shunt system.
An infection can be detected by means of a puncture, for example in a reservoir associated with the valve if the valve is equipped with one, to take a sample of the cerebrospinal fluid. Observing such fluid with the naked eye makes it possible to quickly provide preliminary information regarding the presence of an ongoing infection. A bacteriological analysis is also done in a medical laboratory. However, these sampling methods have a non-zero infectious risk by the puncture, while in some cases, no infection was present beforehand. Often, the infection is detected late, generating serious risks for the patient and very difficult care. It is therefore problematic to implement them regularly, which limits the chances of quickly and preventatively detecting an infection resulting from the valve implant surgery itself or an infection with other origins.
One objective of the invention is to alleviate these disadvantages. One objective of the invention is, in particular, to allow rapid detection of an infection.
According to a first aspect of the invention, a device for measuring the turbidity of cerebrospinal fluid is proposed for this purpose, comprising:
The invention also comprises the following characteristics, taken alone or according to any one of the technically-possible combinations thereof:
The invention also concerns an implant comprising a device (10) according to any one of the preceding claims.
The invention also concerns a method for measuring the turbidity of cerebrospinal fluid by means of such a device or such an implant, comprising the steps of:
The method also concerns a method for manufacturing such a device or such an implant, comprising a step of obtaining the opaque element at the level of at least a part of the flow element, the obtaining step comprising, for example, injecting coloured pigment of the opaque element around the flow element.
Other characteristics, objectives and advantages of the invention will appear from the following description, which is purely illustrative and non-limiting and should be read with regard to the attached drawings, in which:
Throughout the figures, similar elements bear identical references.
In reference to
The device 10 comprises the emission means 120 of a light signal comprising one or more wavelength(s), for example a source capable of emitting a light signal comprising one or more wavelength(s), so that at least a part of the light signal emitted passes through the cerebrospinal fluid.
The device 10 comprises a flow element 110 comprising an inlet and an outlet. The flow element 110 is designed to allow the circulation of cerebrospinal fluid between the inlet and the outlet.
The device 10 comprises an element 130. The element 130 is, for example, an opaque element, for example opaque to the wavelength(s) of the light signal emitted by the source, for example contrasting, for example absorption and/or reflection. The opaque element 130 is arranged, for example disposed at the level of at least a part of the flow element, to absorb at least a part of the light signal emitted after passage through the cerebrospinal fluid, for example after a first passage through the cerebrospinal fluid, and to reflect another part of the light signal emitted after passage through the cerebrospinal fluid, for example a first and/or second passage through the cerebrospinal fluid, for example the part of the flow element and the opaque element also being suitable to allow the reflection of another part of the light signal emitted after passage through the cerebrospinal fluid.
The device 10 comprises optical detection means 140, for example a detector, configured to detect the light signals, for example reflected, after passage through the cerebrospinal fluid.
It is thus possible to obtain a reliable measurement of the cerebrospinal fluid.
During its passages through the cerebrospinal fluid, the light signal emitted then optionally reflected experiences absorption and diffusion phenomena that modify it. For example, if the cerebrospinal fluid is bloody, therefore reddish coloured, the optical signal will be mainly absorbed by the fluid at certain characteristic wavelengths. For example, if the fluid is infectious, in other words whitish, this fluid will diffuse the light signal that passes through it.
It is thus possible to obtain in situ a reliable measurement of the cerebrospinal fluid turbidity. Such a device makes it possible to regularly perform measurements, especially in the weeks following surgery, for example valve surgery, which is typically the period of major infectious risk.
The device is, for example, suitable for detecting a leukocyte density greater than 500 elements/mm3 in cerebrospinal fluid. Indeed, when the cerebrospinal fluid becomes infectious, the turbidity of the cerebrospinal fluid is modified in proportion to the increased density of leukocytes in the cerebrospinal fluid.
The device is, for example, suitable for detecting a haemoglobin and/or oxyhaemoglobin and/or methaemoglobin and/or bilirubin density greater than 1000 elements/mm3 in cerebrospinal fluid. Indeed, in the case of bleeding, for example, the colour of the cerebrospinal fluid can also be modified by the presence of haemoglobin and/or oxyhaemoglobin and/or methaemoglobin and/or bilirubin. Bilirubin is for example linked to the degeneration of red blood cells in the cerebrospinal fluid.
The flow element 110 can be a channel. The flow element 110 can comprise a wall 114 transparent or translucent, for example, to the wavelength(s) of the light signal emitted by the source 120. The flow element 110 is transparent or translucent, for example. The transparent or translucent wall can have a transmission coefficient preferably greater than 80%, for example at the wavelength(s) of the light signal emitted by the source. The transparency coefficient can be the ratio between the light intensity transmitted and the light intensity received, for example by the wall.
The flow element 110 and/or the opaque element can comprise one or more openings 115 opposite which, for example at the level of which, the source and/or the detector can be positioned. The source and the detector can be positioned at the same opening such as illustrated in
The flow element 110 and/or the wall 114, can comprise or be made of a transparent or translucent material, for example, to the wavelength(s) of the light signal emitted by the source. The material can be or comprise silicone, for example implantable silicone, and/or a polycarbonate, for example, a urethane polycarbonate, and/or a polymer, for example a methyl polymethacrylate or a cycloolefin copolymer.
The flow element 110 can comprises an inlet 111 and an outlet 112. The inlet 111 is designed to allow the entrance of cerebrospinal fluid into the flow element. The outlet 112 is designed to allow the exit of cerebrospinal fluid from the flow element 110.
At the inlet 111 and/or the outlet 112, the flow element can comprise a connector. The connector can be a connector for connection to a ventricular catheter. Alternatively, the connector can be a connector for connection to a control valve or means for fluid communication with a control valve.
The flow element 110 can comprise or be a catheter, for example a flexible or rigid catheter, and/or a chamber 1131 and/or a valve. The chamber 1131 is, for example, a pressure measurement chamber, for example for cerebrospinal fluid.
The flow element 110 can comprise an opening 115, for example a window, at which is or are fixed the source 120 and/or the reception means 140.
The source 120 can comprise one or light emitters.
The source 120 can be a source capable of emitting a light signal in the visible spectrum. The light signal emitted can comprise one or more wavelength(s). The source 120 can be designed to emit at least one light signal comprising one or more wavelength(s) comprised between 300 nm and 850 nm,
The source 120 can comprise one or more light-emitting diode(s), for example three or more light-emitting diodes. Each light-emitting diode can make it possible to generate a different light signal from that of the other light-emitting diode(s), for example a light signal of different wavelength from the light signal or signals generated by the other diode(s).
The source 120 can comprise three light-emitting diodes each able to emit a primary colour, for example red and/or green and /or blue.
The source 120 can be disposed upstream or downstream relative to the detector 140. Upstream or downstream means upstream or downstream in the direction of flow of cerebrospinal fluid in the flow element.
In reference to
The detector 140 can be designed to measure the colour level in the cerebrospinal fluid.
The detector 140 can be designed to detect a light signal comprising one or more wavelength(s) comprised between 300 nm and 1000 nm.
The detector 140 can comprise or be a sensor, for example a colour sensor, for example for red and/or green and/or blue colours.
The detector 140 can be designed to measure one or more areas of disjoint wavelengths, each area belonging, for example, to the visible and/or invisible spectrum, for example to the infrared.
The detector 140 can comprise one or more light detectors, for example sensors. The detector 140 can comprise one or more photosensitive surface(s).
In reference to
The device can comprise an assembly 150, for example an optical assembly. In reference to
The assembly 150 or the module can have a length comprised between 3 and 10 mm, for example between 5 and 6 mm. The assembly 150 or the module can have a width comprised between 1 and 3 mm, for example between 1.5 and 2 mm. The assembly or the module 150 can have a thickness comprised between 0.5 and 2 mm, for example between 0.5 and 1.5 mm.
The module forms, for example, a sensor, for example a sensor of the P12347-01CT type sold by Hamamatsu.
The assembly 150 and/or the module can be disposed at the opening 115. The assembly 150 and/or the module can be fixed to the flow element 110, for example, at the opening 115.
The assembly 150 can comprise control means. The assembly 150 or the control means can comprise a control unit 153. The control unit 153 can be designed to control the source 120 and/or the reception means 140. The assembly 150 or the control means can comprise a microcontroller 154, for example, configured to communicate with the control unit 153. The assembly 150 can comprise transmission means 155, comprising, for example, a transmitter, for example a radiofrequency transmitter.
In addition to allowing the reflection of the emitted light signal, the opaque element can also provide a contrast, in particular in the case of a whitish cerebrospinal fluid characteristic of an infection, or red characteristic of a haemorrhage.
The opaque element extends, for example, around at least one portion of the flow element. Alternatively, the opaque element can extend along an inner wall of at least one portion of the flow element, the portion of the flow element extending around the opaque element.
The at least one opaque element 130 can be or comprise at least one layer, for example opaque. The at least one opaque element 130, for example the layer, can be or comprise at least one coating, for example opaque. The at least one opaque element 130, for example the layer or the coating, can be or comprise at least one sheath, for example opaque, for example a sheath for example formed of or comprising implantable silicone filled with coloured pigments, for example black pigments.
The at least one opaque element 130 can comprise a black and/or matte light signal reflection surface. The opaque element can be black in colour.
The opaque element 130 forms, for example, an opaque background, for example a monochrome opaque background.
The at least one opaque element 130 can comprise at least one light ray absorption zone with an absorbance coefficient greater than or equal to 1 CU (concentration unit).
The opaque element is, for example a high-contrast opaque element.
The device can also comprise the pressure measurement means 113, for example for intracranial and/or cerebrospinal fluid pressure. The pressure measurement means 113 are or form, for example, an element for measuring pressure. The pressure measurement means 113 can comprise the pressure measurement chamber 1131 and/or a pressure sensor. In reference to
The pressure measurement means 113 are, for example, disposed upstream or downstream of the source 120 and the detector 140, and preferably upstream of a valve.
In reference to
The implant 20 can comprise a housing 201. The device 10 can extend at least partially within housing 201. The housing can comprise an inlet 2011 and an outlet 2012, for example to permit the inlet 111 and the outlet 112 to extend beyond housing 201. The housing can comprise an enclosure, for example a metal enclosure, for example comprising titanium and/or made of titanium. The enclosure can be coated with a layer of silicone, for example implantable silicone.
The implant can be or comprise a catheter valve assembly for diverting a liquid, for example cerebrospinal fluid. The implant can also comprise the characteristics detailed in the application of the patent holder published under number WO2018007574A1.
In reference to
The method can comprise a first step 301 for circulating the cerebrospinal fluid through the flow element.
The method can comprise a second step 303 of emitting a light signal by the source.
The method can comprise a third step 305 of reflecting by the flow element 110 and/or the opaque element of the emitted light signal after at least one first passage through the cerebrospinal fluid present in the flow element 110.
The method can comprise a fourth step 307 of detecting, by the detection means 140, of the reflected light signal after at least one second passage through the cerebrospinal fluid present in the flow element 110.
The method can comprise a fifth step 309 of transmitting the data corresponding to the measurement performed in step 304, for example data storage means or data processing means.
In reference to
The method can comprise a first step 401 of providing or obtaining the flow element.
The method can comprise a second step 402 of obtaining the opaque element, for example at the level of at least a part of the flow element, the obtaining step comprising, for example, injecting coloured pigment of the opaque element around the flow element.
In reference to
The system can comprise the processing means 501 and/or the storage means 502. The processing means 501 are or comprise a processor, for example. The storage means 502 are or comprise a memory, for example.
The optical absorption A for the resulting wavelength λ of chromophores in a solution can be defined by the Beer-Lambert law:
At a given wavelength λ, absorbance A of a mixture of n absorbing species is the sum of the individual absorbances:
In reference to
The absorption of such chromophores is typically maximum for wavelengths comprised between 250 and 1000 nm.
In reference to
cm-1, as a function of the wavelength, for example in nm. For wavelengths between 250 and 1200 nm, the absorption coefficient of water can be lower than the absorption coefficients of several chromophores, for example oxyhaemoglobin and/or haemoglobin, and/or methaemoglobin and/or bilirubin.
In reference to
The cerebrospinal fluid can comprise water (99%) and/or proteins and/or haemoglobin and/or bilirubin and/or leukocytes, for example depending on the pathological states. For example, the presence of haemoglobin and/or bilirubin can -imply an increase in absorption compared to a healthy fluid, and can therefore characterize a haemorrhagic state. For example, the presence of leukocyte can -imply an increase in diffraction and/or reflection compared to a healthy fluid and can therefore characterize an infectious state. An optical analysis of cerebrospinal fluid is thus possible.
The variation of light intensity received by the measurement means, for example the optical sensors, of the device is shown in reference to
Number | Date | Country | Kind |
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1915742 | Dec 2019 | FR | national |
Filing Document | Filing Date | Country | Kind |
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PCT/FR2020/052642 | 12/30/2020 | WO |