Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
  • A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
  • A61M27/006—Cerebrospinal drainage; Accessories therefor, e.g. valves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/02—Access sites
  • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
  • A61M5/14212—Pumping with an aspiration and an expulsion action
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
  • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
  • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
  • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
  • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
  • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
  • A61M5/1428—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation with manual pumping action
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M2025/0019—Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/02—Access sites
  • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
  • A61M2039/0241—Subcutaneous access sites for injecting or removing fluids having means for filtering
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/75—General characteristics of the apparatus with filters
  • A61M2205/7554—General characteristics of the apparatus with filters with means for unclogging or regenerating filters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2209/00—Ancillary equipment
  • A61M2209/10—Equipment for cleaning

Definitions

• the present invention relates to a medical device comprising a filter and elements for cleaning the filter.
• the invention also discloses a method used for cleaning the filter.
• Some medical devices require the use of a filter so as not to disturb or impair its operation.
• the purpose of this filter is to prevent particles from reaching an element of the device that would be sensitive to it. It may be for example a flow restrictor (also called flow restrictor or flow limiter) or a valve that one or more particles could clog or damage or impair the proper operation.
• a flow restrictor also called flow restrictor or flow limiter
• a valve that one or more particles could clog or damage or impair the proper operation.
• the use of such a filter implies that it is probable or even necessary to have to perform regular maintenance of this filter so that it does not itself alter the operation of the device (for example when the filter is clogged with many particles). Generally, this maintenance consists of replacing the filter. Unfortunately, when it is an implanted device, it is often difficult to perform this maintenance and it is necessary to avoid as much as possible to have to leave the device to simply clean the filter.
• the present document takes the example of a device for cerebrospinal fluid bypass valves (LCR) (but the invention is not limited to this type of device).
• This type of device is used to treat hydrocephalus and it allows to evacuate excess cerebrospinal fluid to another area of the body (eg the peritoneum).
• These devices generally include a fluid path that allows draining excess fluid in the brain.
• Flow control is through a valve that controls either the intracranial pressure or the flow of liquid through the fluid path.
• this valve can also be called flow restrictor, flow regulator or bypass valve.
• This valve can regulate the amount, direction of flow and pressure of cerebrospinal fluid coming out of the brain ventricles.
• the valve opens and excess fluid is evacuated to a cavity downstream.
• the following types of derivations can be used:
• a ventriculoperitoneal shunt discharges the fluid from the ventricles to the abdominal cavity
• a lumbo-peritoneal bypass sheds fluid from the lower back to the abdominal cavity.
• These devices can be placed behind the ear or near the top of the head.
• This document describes a system and method for overcoming the problems encountered by state-of-the-art devices.
• the system is adapted to allow easy maintenance of a filter.
• this aspect of the invention is particularly important because it prevents a device from being released for cleaning.
• the invention can be an advantage because it avoids the disassembly of the system to change the filter, which limits the handling and contamination of the system.
• the device comprises a fluid path in which are arranged a filter, two cavities (arranged on each side of the filter) and a flow restrictor.
• the device is adapted to make flow, in a so-called "normal” operating mode, a fluid in this fluid path passing successively through the first cavity, the filter, the second cavity and the flow restrictor.
• the device is also adapted to flow, according to a so-called “purge” operating mode, a fluid in the same fluid path passing through the filter but in the opposite direction of the normal flow of the fluid (depending on the mode of operation). normal running). Thanks to the "purge" mode, the fluid will remove the impurities attached to the filter in order to clean it.
• the disclosed system is a cerebrospinal fluid bypass valve having greater resistance to obstruction.
• the obstruction may be due to the presence of blood, the agglomeration of proteins or more generally to the presence of debris from the brain. It has been reported that after 2 years of use of a cerebrospinal fluid bypass valve, the failure rate due to occlusion is 20%.
• the invention proposes to add a filtration device (as described above) to a cerebrospinal fluid bypass valve.
• this cerebrospinal fluid bypass valve is disposed in a housing comprising a system (filtration device) as disclosed above so as to be able to clean the filtration device in the least invasive and secure manner possible possible.
• the invention relates to a method of non (or little) invasive maintenance of an implanted filtration device.
• the method preferably uses the filtration device described in the first aspect of the invention.
• the method includes generating a pressure in the cavity to constrain at least a portion of the pressurized fluid to pass through the filter in the opposite direction of the normal flow mode.
• a user can crush a fluid volume for example if the fluid path comprises at the second cavity a flexible portion, the user can press this flexible portion.
• Another solution would be to inject a fluid directly into the second cavity using for example a syringe or a separate mechanical pump fluidly connected reversibly to the second cavity.
• Figures 1a and 1b schematize the filter device according to two modes of operation.
• Figures 2a and 2b illustrate an embodiment of a bypass system comprising a filter device.
• Figures 3a, 3b, 3c and 3d schematize three modes of operation of the system.
• Figure 4 shows an embodiment implanted under the skin of a patient.
• upstream and downstream refer to the location of the elements relative to each other according to the normal flow of the fluid (that is to say, according to the normal operating mode).
• FIG. 1a discloses the principle of two modes of operation of the filter device (1).
• This filtration device comprises a fluidic path (2) in which are successively arranged a first cavity, a filter (3), a second cavity (4) and a flow restrictor (5).
• the fluid flows in a direction of flow (6) which goes from the filter to the flow restrictor.
• the fluid flows in a direction of flow (6 ') which goes from the second cavity to the first cavity while passing through the filter, as disclosed in Figure 1b and passes through the filter to clean it.
• the advantage of the flow restrictor (5) can be to constrain, during a purge, at least a portion of the fluid to pass through the filter in the opposite direction (6 ') to the flow in normal mode (use normal). It would be possible to replace the restrictor by (or add upstream of the flow restrictor but downstream of the second cavity) any other means limiting or preventing the flow of fluid through this means in the second mode of operation. It could be an occlusion means such as a passive or active valve, a tube or flexible chamber that could be crushed or closed by the user in the second mode of operation.
• the flow restrictor may be a valve that partially or totally closes when the pressure of the fluid in the cavity reaches a predetermined threshold (for example a flow regulator that regulates the flow over a determined range of pressure fluid present in the second cavity). It can also be a constant or variable fluid resistance as a function of the pressure exerted in the cavity (4).
• the device may comprise a purge valve arranged at the level of the first cavity (that is to say upstream of the filter).
• the "purge" operating mode would open the purge valve (8) (as shown in Figure 1b) either because of the pressure, because of the direction of the flow or by an action of the 'user.
• the fluid path disposed upstream of the first chamber comprises a non-return valve or an occluding means so that the pressurized fluid does not go up the fluid path and is forced out through the purge valve.
• the purge valve (8) can open when the fluid pressure in the vicinity of the purge valve reaches a predetermined threshold level or via an actuated mechanism (eg via the finger of a user, physician, patient,.
• the operating mode "purge” can be activated by means that will bring pressure (7) a fluid in the second cavity. This engagement can be the fact of pressing on a flexible zone of the wall of the second cavity or the injection of a fluid inside the second cavity with the aid of a syringe or a mechanical pump distinct fluidically reversibly connected to the second cavity.
• the "purge" operating mode can be activated following (or when) a differential pressure (between the first and second chamber) causes the fluid to move from the second cavity to the first cavity. For example, it is possible to create an overpressure in the second cavity relative to the pressure of the first cavity. It is also possible to promote the displacement of the fluid by creating an overpressure in the second cavity and / or under pressure in the first cavity.
• the flow of the fluid in the second mode of operation is effected in a direction opposite to the flow of the fluid during the first mode of operation, at least at the level of the filtering device.
• the filtration device is adapted to be implemented in a system comprising a flow regulator such as a cerebrospinal fluid bypass valve.
• a flow regulator makes it possible either to maintain the fluid upstream of the regulator at a determined pressure by varying the flow rate of the regulator (preferably), or to restrict the regulator flow rate despite the pressure variation upstream of the regulator.
• Such regulators are described by the international patent applications bearing the following publication numbers: WO93 / 10389 A1, WO2009 / 098314 A1, WO2010 / 020891 A1, WO201 1/098867 A1, WO201 1/098946 A1 and WO2014 / 108860 A1. The content of these requests is incorporated by reference into this document.
• FIGS. 2a and 2b disclose a fluidic bypass system comprising a fluid inlet (101), at least one fluid outlet (102, 102 ', 102 "), a filter (3), two cavities (4, 4'), a regulator a flow valve (8) and, optionally, a purge valve (8), the filter-cavity-regulator assembly is arranged in a first fluid path and arranged in such a way that, according to a first operating mode, a fluid enters the the fluid inlet (101) passes successively through the first cavity (4), the filter, the second cavity (4 ') and then the flow regulator and reaches at least one outlet (102, 102').
• a second fluid path may include a purge valve (8), a flow restrictor, or a check valve, whereby to reach an outlet of the system, the fluid may pass either through the first fluidic path comprising the flow regulator (flow restrictor or valve) or by the second fluid path (for example the purge valve).
• the filter, the cavity, the flow regulator and the purge valve are arranged inside the same housing.
• This casing can be adapted to be implanted, it can thus be composed of a material compatible with this function and / or it has a size adapted to be implanted in the body of a patient, for example at the nape or neck. the ear.
• Fig. 2a shows a device having a single fluid outlet into which fluid from the flow regulator (103) flows and fluid from the purge valve (8).
• Figure 2b shows a device with two separate fluid outlets, one for the fluid from the fluid regulator and the other for the fluid from the purge valve.
• the second cavity (4 ') is adapted so that the fluid contained in this cavity can be carried under pressure therein.
• a wall of the cavity (which may be a wall of the housing) may comprise:
• a septum (104) so as to allow the tip of a needle to penetrate the cavity and inject a fluid (water, serum, drug, liquid, gas, ).
• a protector (105) may be disposed in the cavity so as to protect the filter or to limit the penetration of the needle. This protection can also allow (by its shape, its design) a better diffusion of the injected fluid so as to unclog the major part of the filter.
• a flexible wall (104) (for example of concave shape and of sufficient capacity) that a user can crush so as to pressurize the fluid already present in the cavity.
• a guard (105) can also limit the deformation of the flexible wall.
• Figures 3a, 3b, 3c and 3d show 4 possible modes of operation.
• the operating mode of Figure 3a may be called the main operating mode or first operating mode or normal operating mode.
• a fluid e.g. cerebrospinal fluid
• enters the fluid inlet of the bypass system passes successively through the first cavity, the filter, the second cavity and the flow regulator to reach the fluid outlet.
• the flow regulator will allow regulation of intracranial pressure or liquid flow in the bypass system.
• the operating mode of FIG. 3b makes it possible, in the event of significant pressure in the device, to unload all or part of the fluid through the second fluid path which may comprise a bleed valve or a high-pressure valve or an anti-return valve.
• This valve can be adapted to open only when the pressure of the fluid (in the first chamber) reaches a predetermined threshold. This may be an operating mode that executes when the filter and / or flow restrictor is clogged.
• a needle penetrates the septum of the second cavity to inject a fluid into the second cavity.
• This needle refers to a fluidic connection means of an injection device (and puncture in the case of Figure 3d) such as a syringe or a more complex device comprising a pump adapted to move a fluid.
• the pump can be connected to a tank adapted to contain or receive a fluid (gas or liquid).
• This fluidic connection means can be reversibly connected to the second cavity or first cavity.
• this connection means may be a port connected to a pump and a reservoir whose assembly is part of the medical device arranged for example in the same housing.
• the injection must make it possible to reach a certain pressure or a certain flow rate (greater than the outflow rate of the flow regulator). As the entire fluid will fail to drain through the flow regulator (or if the flow regulator is closed or prevents some or all of the fluid from flowing). Thus at least a portion of the injected or pressurized fluid will be forced to pass through the filter in the opposite direction to the normal flow (illustrated in Figure 3a).
• the system may include one or more check valves (109, 109 ', 109 ") to constrain the flow of fluid, in particular, the anti-return valve (109) prevents the fluid does not exit through the fluid inlet of the system, the anti-return valve (109 ") makes it possible to prevent the fluid from entering through a fluid outlet of the system and, the anti-return valve (109 ') makes it possible to prevent the fluid from contaminating the flow regulator.
• the first cavity makes it possible to insert a needle so as to puncture the liquid charged with particles resulting from the cleaning of the filter.
• the second cavity (4) may comprise a membrane separating said cavity into two distinct sub-cavities and sealed (with respect to each other).
• the first sub-cavity could be in fluid communication with the flow regulator and the filter while the second sub-cavity could be in contact with the septum (104).
• the membrane could be made of a flexible material so that both sub-cavities are in pressure communication. This embodiment makes it possible to temporarily inject a fluid into the second cavity via a syringe or via a pump (for example). This injection will induce a displacement of the membrane which will result in increasing the pressure in the other sub-cavity so as to clean the filter. The added fluid can then be partially or completely removed from the second sub-cavity.
• the system may not include the septum and the intermediate membrane may be moved by another means known to those skilled in the art, for example by an actuator (electronic or not) such as a piezoelectric.
• an actuator electronic or not
• a bypass system is implanted under the skin (107) of a patient.
• the fluid inlet (101) and the fluid outlet (102) may be connected to catheters not shown in Figure 4.
• the system is protected in a housing (108) that includes a flexible portion (104).
• the finger (105) of a user can press (106) on the flexible portion (104) to increase the pressure in the cavity and constrain the fluid to pass through the second fluid path including the bleed valve (8) (which can also have the function of non-return valve).
• the user may perform several finger motions (106) to initiate a pumping mechanism to clean the filter or force the bypass. For example, in case of high intracranial pressure, the patient may suffer from severe headaches and pumping will allow him to quickly relieve his headaches and clean the filter.
• the filter has ideally a large filtration area, with a pore size adapted to the dimensions of the flow regulator.
• the pore size can vary between 0.1 ⁇ and 10 ⁇ , with a typical size of 1 ⁇ .
• the filter material may be hydrophilic to limit protein adsorption.
• the pore density can be between 0.1% and 30%.
• the thickness of the filter can be between 0.01 mm and 10 mm.
• the filtration surface may be between 0.1 cm 2 and 100 cm 2.
• a mechanical support may be necessary (support grid %) to ensure the proper maintenance of the filter in the system during the purge, because a pressure of several bars can be generated by a syringe or a pump.
• the system may include a pore size pre-filter> 1 ⁇ . This pre-filter can be oriented perpendicular to the direction of flow during a high pressure that induces an opening of the purge valve, to drive the largest debris to the outlet.
• the system can also contain a pressure sensor that can be read and powered by wireless technology (induction, microwave, radio, ).
• This sensor can in particular to diagnose the system and in case of suspicion of occlusion, a purge can be performed before the patient feels the first symptoms.
• the flow regulator is adjustable, that is to say it can be adjusted after reading the pressure sensor to open or partially close during the purge or after detection of an occlusion. If purging is ineffective, an adjustment of the valve opening may be necessary to prevent surgery.
• the purge valve can be adjustable and thus allow the system to be adjusted to the physiology and characteristics of the patient (height of the water column, ie the difference in height between the top of the device (the brain) and the other end through which fluid exits the system (eg the peritoneal cavity, ).
• the pressure sensor may be an absolute pressure sensor placed upstream of the filter so as to accurately know the intracranial pressure. In this way, the sensor could be able to diagnose both the device and the therapy.
• a flow meter placed near the fluid inlet or fluid outlet could also help diagnose the device and the patient.
• the flowmeter may be a thermal flowmeter comprising a heating resistor and two temperature sensors respectively placed upstream and downstream of the heat source.
• the system may comprise two separate fluid outlets (two catheters or a double lumen catheter), each of which can be connected respectively to the flow regulator and the purge valve. This limits catheter or lumen occlusion at the output of the flow regulator and prevents contamination of the flow regulator outlet (as explained above).
• the flow regulator and the purge valve may be two separate devices connected in parallel (eg by tubes).
• the filtration device is connected to a vibrating device (for example of the piezoelectric type), which makes it possible to apply vibrations to the system and to detach the debris from said filter.
• This vibrator could be powered by wired or wireless system (induction, microwave, radio, ).
• a medical device in a preferred embodiment, includes a fluid inlet port, a fluid outlet port, a first cavity, a second cavity, a means for increasing the pressure in the second cavity, a filter device, and a flow restrictor arranged so that, in a first mode of operation, a fluid enters the fluid inlet and passes successively into the first cavity, the filter device, the second cavity and the flow restrictor; flow to reach the fluid outlet.
• the second cavity is designed to allow an increase in the pressure within it through said means (to increase the pressure in the second cavity) so that, according to a second mode of operation, the compressed fluid (through said means) passes from the second cavity to the first cavity through the filter device.
• the means for increasing the pressure in the second cavity is designed to allow the medical device to operate in a second mode of operation. All the features disclosed in this document are compatible with this embodiment.
• the fluid inlet of the medical device comprises an anti-return valve so that during the second mode of operation, the compressed fluid does not exit through the fluid inlet.
• the means for increasing the pressure in the second cavity may include a fluid inlet through which fluid may be injected directly into the second cavity without passing through the fluid inlet.
• the means for increasing the pressure in the second cavity may further comprise a septum adapted for the insertion of a needle and optionally a protective element disposed opposite the septum in the cavity, so that a needle can not damage an element of the medical device such as the filter device.
• the flow restrictor may be a valve, a non-return valve, an anti-siphon valve, a fixed or variable fluid resistance flow regulator or an occluder.
• the medical device may include a second fluid outlet port capable of permitting outward flow of the medical device during the second mode of operation.
• the second fluid outlet port may include a valve which may be a non-return valve.
• the first cavity may be adapted so that a needle can be inserted for the collection of all or part of the fluid during the second mode of operation.
• the means for increasing the pressure in the second cavity may comprise a flexible wall adapted to be compressed by a user or another fluid so as to pressurize the fluid present in the second cavity.
• the medical device may include a pressure sensor.
• the pressure sensor can be an absolute pressure sensor.
• the pressure sensor may be arranged upstream of the filtering device in the direction of fluid flow of the first operating mode.
• the pressure sensor may be arranged downstream of the filter device but upstream of the fluid restrictor in the fluid flow direction of the first operating mode
• the pore size of the filtering device may vary between 0.1 ⁇ and 10 ⁇ , preferably 1 ⁇ .
• the thickness of the filtering device may be between 0.01 mm and 10 mm.
• the filtration surface may be between 0.1 cm 2 and 100 cm 2 .
• the material of the filter device or the coating of the filtering device may be hydrophobic so as to limit the adsorption of proteins by the filtering device.
• the density of the pores of the filter can be between 0.1 and 30%.
• the medical device may not include a flow restrictor, in which case the core of the invention relates to a filter cleaning means arranged upstream of a device to be protected.
• the medical device may comprise an occlusion means disposed downstream of the second cavity.
• the medical device may include a fluid inlet, a fluid outlet, a first cavity, a second cavity, a means for increasing the pressure in the second cavity, a filtering device, and a means for increasing the pressure in the second cavity.
• (partial or total) occlusion arranged so that, in a first mode of operation, a fluid enters through the fluid inlet and passes successively in the first cavity, the filter device, the second cavity and the occluding means for reaching the fluid outlet.
• the second cavity is designed to allow an increase in the pressure within it through said means (for increase the pressure in the second cavity) so that, in a second mode of operation, the fluid passes from the second cavity to the first cavity through the filter device.
• the occlusion means is operable by the user to prevent or limit the flow of fluid through the occlusion means during the second mode of operation.
• the invention also relates to a method for cleaning a filter of a medical device as disclosed above for example comprising an access means for injecting a fluid (stored in an external reservoir for example a syringe ) in the second cavity (with or without a membrane separating into two sub-cavities), said method can comprise the following steps:
• Fluidic communication setting the reservoir and the second cavity for example by inserting a needle through the means of access to the second cavity (for example a septum),
• the invention also describes another method for cleaning a filter of a medical device as disclosed above for example comprising a flexible wall (for example of concave shape so as to create a fluid reservoir in the second cavity of sufficient size to cause displacement of a volume necessary for cleaning) on which the user can exert pressure to pressurize the second cavity, said method may comprise the following steps:

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Anesthesiology (AREA)
• Veterinary Medicine (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Vascular Medicine (AREA)
• Otolaryngology (AREA)
• Neurology (AREA)
• Ophthalmology & Optometry (AREA)
• Pulmonology (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• External Artificial Organs (AREA)

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• 2016
  • 2016-07-08 EP EP16753701.8A patent/EP3319661A1/de not_active Withdrawn
  • 2016-07-08 US US15/741,539 patent/US11020572B2/en active Active
  • 2016-07-08 JP JP2018500409A patent/JP6900360B2/ja active Active
  • 2016-07-08 WO PCT/IB2016/054117 patent/WO2017006293A1/fr unknown

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