Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
  • A61B5/021—Measuring pressure in heart or blood vessels
  • A61B5/02141—Details of apparatus construction, e.g. pump units or housings therefor, cuff pressurising systems, arrangements of fluid conduits or circuits
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
  • A61B5/02007—Evaluating blood vessel condition, e.g. elasticity, compliance
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
  • A61B5/024—Measuring pulse rate or heart rate
  • A61B5/02416—Measuring pulse rate or heart rate using photoplethysmograph signals, e.g. generated by infrared radiation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
  • A61B5/024—Measuring pulse rate or heart rate
  • A61B5/0245—Measuring pulse rate or heart rate by using sensing means generating electric signals, i.e. ECG signals
  • A61B5/02455—Measuring pulse rate or heart rate by using sensing means generating electric signals, i.e. ECG signals provided with high/low alarm devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
  • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
  • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
  • A61B5/6813—Specially adapted to be attached to a specific body part
  • A61B5/6829—Foot or ankle
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
  • A61B5/026—Measuring blood flow
  • A61B5/0261—Measuring blood flow using optical means, e.g. infrared light
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/74—Details of notification to user or communication with user or patient; User input means
  • A61B5/7405—Details of notification to user or communication with user or patient; User input means using sound

Definitions

• the invention relates generally to the field of screening for the peripheral arterial disease of the limbs, particularly the lower limbs, of patients.
• Obliterative arterial disease of the lower limbs is a common complication of diabetes, affecting between 17% and 21% of the diabetic population.
• This vasculopathy associated with a small trauma and diabetic neuropathy, is responsible for the diabetic foot ulcer that precedes approximately 85% of amputations. Simple measures prevent this daunting complication when this vasculopathy is identified in time.
• the invention relates to a tool comprising a compression body having a contact surface, the compression body being adapted to cooperate with a portion to be compressed of a patient's limb so that the contact surface comes into contact. non-punctual or quasi-punctual with the portion to be compressed of the patient's limb; compression means capable of compressing this contact surface against this portion to be compressed of the patient's limb so as to generate on said portion to be compressed a measurement pressure substantially homogeneous and equal to a pressure threshold value during a phase of compression; measuring means able, on the one hand, to cooperate structurally and functionally with a test portion of the patient's limb and, on the other hand, to generate, by optical detection of one or more constituent (s) of the blood, a measurement signal characteristic of an arterial pulse in the portion to be examined of the patient's limb during a measurement phase.
• microciculatory techniques alternatives to the measurement of the IPS of the ankle.
• the first of these techniques is implemented by an apparatus marketed under the trademarks Perimed® and Periflux System 5000®.
• the apparatus includes a compression body and compression means for applying a plurality of compressive pressures to a portion of the patient's large toe, and an arterial flow compression system based on Doppler laser technology to measure the pressure. blood pressure in the big toe. It can also be equipped with a probe for measuring the transcutaneous oxygen pressure (TcPo2).
• TcPo2 transcutaneous oxygen pressure
• this first technique also has drawbacks.
• the examinations carried out to obtain the necessary measures for the development of these diagnoses require lengthy examination protocols, the time-consuming nature of which is a serious obstacle to the frequent and regular implementation of this technique.
• the investment cost of such a device is often prohibitive and therefore limits its use to some specialized hospitals.
• obtaining a reliable diagnosis necessarily requires the intervention of a specialized practitioner capable of analyzing the curves giving a signal intensity representative of the arterial flow rate as a function of the different compression pressures.
• it is well known that the availability of these specialized practitioners is not sufficient to allow the deployment of these techniques to a large extent.
• the other alternative technique to the measurement of the IPS relates to an apparatus marketed by Atys Médical® under the brand name Systoe®.
• this apparatus comprises a compression body and compression means for applying different compression pressures to the portion to be compressed of the patient's big toe.
• this one uses the principle of photoplethysmography consisting in using the relation between the intensity of the light reflection on the portion to be examined and the blood flow passing through the zone studied as a principle of detection, depending on the variation of compression pressure imposed on the portion to be compressed.
• WO-A1-2004 / 073514 discloses a diagnostic device comprising a compression system capable of exerting a predetermined pressure on the surface of a tissue in order to start a laundering, then release that pressure after a predetermined time.
• the device incorporates an optical system that illuminates the tissue and collects reflected light data - during the bleaching phase and after the bleaching phase - to enable a microcontroller to perform a diagnosis of the subject fabrics.
• this solution involves the linking of the pressure measurements with the reflected light data obtained and the implementation of a complex classification algorithm of the results, which makes it compulsory to use a material that is still too expensive. and, therefore, prohibitive for non-specialists.
• US-B-5,755,229 a measuring device for diagnosing the condition of a patient's limbs.
• This device comprises an inflatable band that can be wound around the patient's limb, a pump, an air duct and a pressure sensor capable of inflating the inflatable band at several predefined pressures, and an optical signal sensor for measuring the plethysmogram. of the member in question.
• the device further includes a CPU for diagnosing from a plurality of signals corresponding to the pulses measured by the optical signal sensor when different pressures are applied to the patient's limb.
• the present invention aims to provide a device free of at least one of the limitations mentioned above.
• the invention aims to provide a tool for detecting an abnormality such as arterial occlusive disease that is both simple to implement and less expensive than existing devices.
• the screening tool according to the invention also complies with the generic definition given in the preamble above, is essentially characterized in that it comprises, on the one hand, suitable calculation means from a measured signal corresponding to the measurement signal generated by the measuring means during the compression phase, outputting a negative diagnostic signal when the arterial pulse in the portion to be examined is greater than a diagnostic threshold value and to emit a positive diagnostic signal when this arterial pulse is below this diagnostic threshold value and, secondly, suitable means of expression. expressing negative diagnostic information upon receipt of the negative diagnostic signal from the computing means.
• this embodiment it is possible to perform the screening for an abnormality such as arterial occlusive disease without the need to implement a compression technique with a setting variable compression of the arteries. Furthermore, the compression means and the measuring means can be treated completely independently since it is no longer a question of correlating a pressure measurement with the signal measured by the measuring means. On the contrary, in this case the compression phase during which the measurement pressure is applied to the portion to be examined is maintained throughout the duration of the measurement phase. Thus, it is no longer necessary to use a control system between these two subassemblies which greatly simplifies the device and allows, on the one hand, to increase the compactness of the device as well as its portability and, of on the other hand, significantly reduce the manufacturing costs of the device.
• this arrangement makes it unnecessary to analyze several measurement curves to interpret them in relation to each other.
• diagnostic information without requiring the intervention of specialized practitioners in this field.
• this screening tool which does not require any medical interpretation after the measurements have been made is also much faster to implement and thus saves a lot of time in performing the screening.
• the compression body comprises at least one flexible portion made of a flexible and atraumatic material. This makes it possible to maintain a position that is both reliable and pleasant for the patient.
• the compression body comprises the at least one flexible portion and a rigid or semi-rigid peripheral wall; the at least one flexible portion is fixed permanently, directly or indirectly, on the peripheral wall; and the contact surface is formed in part or in full on the at least one flexible portion.
• the at least one flexible portion comprises an inner chamber adapted to contain, hermetically, a fluid introduced into the inner chamber via a fluid inlet.
• the compression body comprises a single flexible portion made of a flexible and atraumatic material and a peripheral wall; that the unique flexible portion is fixed permanently, directly or indirectly, on the peripheral wall; and that the contact surface is formed entirely on the single flexible portion.
• the compression body comprises a sleeve, comprising: a wall, external and peripheral, made of a flexible and atraumatic material; a fluid inlet corresponding to a structural and functional opening made in the outer and peripheral wall; and an inner chamber delimited by the outer and peripheral wall and adapted to contain, hermetically, a fluid introduced into this inner chamber through the fluid inlet.
• the compression means comprise a discharge member capable of generating a flow of fluid and transfer means able to transport the fluid from the discharge member and up to the fluid inlet of the compression body so as to effect a transfer of fluid from the compression means and to the inner chamber of the compression body through this fluid inlet.
• the delivery member of the compression means may comprise a bellows, a pump or the like.
• the compression means comprise a calibrated valve capable of releasing a portion of the fluid from the inner chamber of the compression body as long as said fluid generates in said compression chamber a measurement pressure greater than a predetermined pressure threshold value.
• the calibrated valve it is also possible for the calibrated valve to be able to pass from a first state in which the pressure threshold value corresponds to a first predetermined threshold value to a second state in which the pressure threshold value corresponds to a second predetermined threshold value.
• the patient can thus perform two different screening tests from two different measurement pressures.
• the flexible material is a silicone.
• the compression body comprises an inextensible band capable of being deformed so as to grip the portion to be compressed of the patient's limb; the strip having a width greater than 2 mm (millimeters).
• the compression means are able to exert a clamping force on the inextensible band of the compression body when this inextensible band encloses the portion to be compressed so as to generate on said portion to be compressed a measurement pressure substantially equal to pressure threshold value during the entire measurement phase.
• the compression means comprise an elastic element permanently fixed on one end of the inextensible band; the elastic member being adapted to move from a detent position to a tension position in which said elastic member generates a restoring force corresponding to the clamping force.
• the compression body is a single-use element, which prevents the transmission of bacteria between different patients;
• the compression means are adapted to generate on the portion to compress a measuring pressure, fixed or not, in a range from 30 to 80 mmHg (millimeters of mercury), wherein the measures achieve significant results .
• the measuring means comprise a light source such as a laser diode capable of emitting light emission rays towards the portion to be examined of the patient's limb, the emission light rays having predetermined emission characteristics ; a receiver such as a photodiode adapted to receive receiving light rays transmitted or backscattered by the portion to be examined of the patient's limb, the reception light rays having predetermined reception characteristics; and a calculation unit adapted to compare the emission characteristics with respect to the reception characteristics so as to deduce therefrom the measurement signals characteristic of the arterial pulsation in the test portion of the patient's limb.
• a light source such as a laser diode capable of emitting light emission rays towards the portion to be examined of the patient's limb, the emission light rays having predetermined emission characteristics
• a receiver such as a photodiode adapted to receive receiving light rays transmitted or backscattered by the portion to be examined of the patient's limb, the reception light rays having predetermined reception
• the calculation means are able to deduce from the measurement signal a useful signal characteristic of the arterial pulsation in the portion to be examined of the patient's limb.
• the calculation means are able to cancel the pseudo-continuous parasitic component. measuring signals and amplifying the measurement voltage of the useful component.
• the calculation means are able to compare the amplified measurement voltage with a comparison threshold voltage so as to emit a negative diagnostic signal when the amplitude of the amplified measurement voltage is greater than the amplitude of the measurement voltage.
• either the light source and the receiver are able to be positioned on either side of the portion to be examined of the patient's limb so that the receiving light rays correspond to the light emission rays having passed through the portion examining the limb of the patient, the light source is able to be positioned in proximity so that the light receiving rays correspond to the light emission rays retrodiffused by the portion to be examined of the patient's limb.
• the light source can be structurally linked to the receiver; the light source and the receiver being arranged together in a receiving element.
• the compression body comprises a sleeve
• the light source and the receiver are positioned in the inner chamber delimited by the outer wall of the sleeve.
• the measuring means comprise a receiving element having an outer protective wall delimiting a protected internal space, the light source being positioned at least partly to inside the protected internal space.
• the receiver may also be positioned at least partly within the protected internal space.
• the receiving element can be adapted to be placed and held in position, directly or indirectly, by the rigid or semi-rigid peripheral wall of the compression body.
• the receiving element can then be adapted to be placed and held in position, indirectly, by the rigid or semi-rigid peripheral wall; the receiving element being arranged between two flexible portions.
• the screening tool also comprises heating means capable of maintaining or raising in temperature at least a portion of the patient's limb.
• the heating means may be able to maintain or raise in temperature the portion to be compressed and / or the portion to be examined of the patient's limb.
• the heating means may comprise a piece of clothing capable of covering and wrapping at least a portion to cover the patient's limb; the piece of clothing being formed from a thermally insulating fiber so as to maintain or raise the temperature at least a portion to cover the patient's limb.
• the diagnostic tool may include a temperature probe capable of measuring the temperature of at least a portion of the patient's limb, preferably the portion to be examined of the patient's limb.
• the temperature probe can be integrated into the clothing part.
• the heating means comprise a piece of clothing
• the piece of clothing may incorporate the compression body, the compression means and / or the measuring means.
• the heating means comprise a piece of clothing
• the piece of clothing may be for single use.
• the patient's limb is a foot, the portion to be compressed and the portion to be examined being positioned on the big toe.
• the portion to be compressed is positioned on the first phalanx of the big toe and the portion to be examined is positioned on the second phalanx of the big toe. In one embodiment the portion to be compressed and the portion to be examined are positioned on the second phalanx of the big toe.
• the piece of clothing is able to isolate the big toe from the other toes of the patient.
• FIG. 1 is a perspective view of a first embodiment of the screening tool according to the invention wherein the compression body and the compression means are structurally independent of the measuring means;
• Figure 2 is a sectional view A-A of the compression means of the screening tool illustrated in Figure 1;
• Figure 3a is a perspective view of the compression body and compression means of the screening tool illustrated in Figure 1, placed in a tension position;
• Figure 3b is a perspective view of the compression body and compression means of the screening tool illustrated in Figure 1, placed in a detent position;
• FIG. 4 is a perspective view of the measuring means of the screening tool illustrated in FIG. 1;
• Figure 5 is a sectional view BB of the measuring means of the screening tool according to the invention illustrated in Figure 1;
• Figure 6 is a perspective view of a second embodiment of the screening tool according to the invention wherein the compression body comprises an inflatable sleeve;
• Figure 7 is a schematic representation of the screening tool illustrated in Figure 6, in a voltage position
• Figure 8a is a schematic representation, in section, of the screening tool illustrated in Figure 6 in a voltage position and wherein the measuring means comprises a light source and a receiver arranged outside the inflatable sleeve;
• Figure 8b is a schematic representation, in section, of the screening tool illustrated in Figure 6 in a voltage position and wherein the measuring means comprises a light source and a receiver arranged within the inflatable sleeve;
• Figure 9 is a perspective view of a third embodiment of the screening tool according to the invention wherein the compression body comprises an inflatable sleeve and the measuring means operate in transmission;
• Figure 10 is a schematic representation, in section, of the screening tool illustrated in Figure 9 in a tension position. It should be noted, first of all, that the screening tool 2 according to the invention is particularly applicable in the context of screening for an abnormality such as arteriopathy obliterans of the lower limbs.
• FIG. 1 illustrates a first embodiment of a screening tool 2 according to the invention intended to identify in a patient a peripheral arterial occlusion of the lower limbs.
• This screening tool 2 comprises a compression body 20 formed by an inextensible band 22 having a first end 22a, a second end 22b and an inner face, said contact surface 24, intended to bear on the portion 10a to compress the member 10 of the patient.
• the inextensible band 22 is also able to deform so as to grip the portion to be compressed 10a of the member 10 of the patient.
• This inextensible band 22 has a length sufficient to surround the portion to be compressed 10a of the member 10 of the patient and a width greater than 2 millimeters, preferably equal to 15 millimeters.
• the contact surface 24 comes into non-point or quasi-point contact with this portion to be compressed 10a. More particularly, the width of the inextensible band 24 and the fact that the contact is neither punctual nor quasi-punctual makes it possible not to traumatize the portion to be compressed 10a but on the contrary to compress it in a substantially homogeneous manner, without causing discomfort to the patient .
• the inextensible band used may be single-use and replaced for each new screening operation. Thus, the risk of bacterial contamination between patients is limited.
• this inextensible band 22 are such that it makes it possible to grip the portion to be compressed 10a of the member 10 of the patient.
• this portion to be compressed 10a corresponds to the first phalanx of the big toe but if the portion to be compressed 10a was - for example - an ankle, the length of the inextensible band 22 would be increased.
• the screening tool of FIG. 1 also comprises compression means 30 capable of compressing the contact surface 24 of the inextensible band 22 against the portion to be compressed 10a.
• These compression means 30 comprise a support tube 32, inside which is defined a receiving cavity 34 in which is arranged an elastic element 36, such as a spring.
• the support tube 32, the receiving cavity 34 and the elastic member 36 all extend in a longitudinal direction.
• these compression means 30 also comprise a slide element 38.
• FIGS. 2, 3a and 3b illustrate in greater detail the association of the compression body 20 with the compression means 30.
• the support tube 32 comprises a peripheral wall 32p, a first end 32a, a second end 32b, a guide groove 32r formed on the wall 32p device and a slot 32f formed on the first end 32a of the support tube 32.
• the guide groove 32r which also extends in the longitudinal direction defined, as the slot 32f, an opening to the receiving cavity 34.
• the element slide 38 has an inner portion 38a arranged inside the receiving cavity 34 and capable of sliding in this receiving cavity 34 in the longitudinal direction.
• the slide member 38 also has an outer portion 38b external to the receiving cavity 34 and extending through the guide groove 32r.
• the elastic member 36 is positioned between the first end 32a and the inner portion 38a of the slide member 38. In this way, when the outer portion 38b of the slide member 38 is brought closer to the first end 32a of the support tube 32 , the elastic element 36 is compressed by the inner portion 38a of the slide element 38. This elastic element 36 then generates a restoring force F tending to bring the slide element 38 of the second end 32b of the support tube 32.
• FIG. 2 shows, on the one hand, that the first end 22a of the inextensible band 22 is fixed so as to be permanently fixed on the first end 32a of the support tube 32, more precisely between the first end 32a of the tube support 32 and a split ring 32a '.
• the inextensible band 22 makes a loop outside the support tube 32, passes through the slot 32f, the split ring 32a ', the elastic member 36, and its second end 22b is fixed in the inner portion 38a of the slide element 38.
• the outer portion 38b of the slide element 38 of the first end 32a of the support tube 32 must be brought together so as to compress the elastic element 36.
• the second end 22b of the inextensible band 22 approaches the first end 32a of the support tube 32 and relaxes this inextensible band 22. It is then possible to engage the lasso formed by the inextensible band 22 around the portion to be compressed 10a member 10 of the patient.
• this position is called the detent position because the inextensible band 22 is relaxed.
• this position is said tension position because the inextensible band 22 is stretched.
• This configuration makes it possible to adjust the pressure exerted by this inextensible band 22 on the portion to be compressed 10a as a function of the geometry of the compression body 20 and the compression means 30 used. To do this, the stiffness of the elastic element 36 must be calculated from the conventional formula connecting the force to the pressure:
• ⁇ F the force exerted by the inextensible strip 22 of the portion 10a to compress (expressed in Newtons) which is perpendicular to the contact surface 24 and which is uniformly distributed over the whole contact surface 24;
• ⁇ S the area between the portion to be compressed 10a and the contact surface 24 of the inextensible band 22.
• these compression means 30 are thus able to exert a clamping force on the inextensible band 22 of the compression body 20 so that, when this inextensible band 22 encloses the portion to be compressed 10a, it generates on said portion to compress 10a.
• a measurement pressure substantially equal to a pressure threshold value determined beforehand, and during a qualified phase phase compression.
• this pressure threshold value is between 35 and 40 mm Hg (millimeters of mercury), values for which an absence Arterial circulation could be considered an anomaly.
• the elastic element 36 acts in compression on the slide element 38.
• the elastic element 36 would be positioned between the second end 32b of the support tube 32 and the slide element 38 and in which the elastic element 36 then act in traction on the slide element 38.
• FIGS. 4 and 5 illustrate the measuring means 40 used by the screening tool, illustrated in FIG. 1, during a measurement phase carried out after the introduction of the compression body 20 and the actuation of the means of measurement. compression 30.
• These measuring means 40 are able to cooperate structurally and functionally with the portion to examine 10b of the limb 10 of the patient, that is to say in this embodiment with the second phalanx of the big toe.
• These measuring means 40 comprise a peripheral frame 42 of rectangular shape, defining a receiving space 44 and supporting two flexible portions of stop 46a arranged at two adjacent corners of the peripheral frame 42 and two flexible holding portions 46b arranged inside the receiving space 44.
• the flexible abutment 46a and 46b holding portions are, for example, made of silicone.
• the two flexible holding portions 46b are fixed, structurally and functionally, relative to one another but capable of moving relative to the peripheral frame 42.
• clamping pieces 48 make it possible to block the flexible holding portions 46b with respect to the peripheral frame 42 when a suitable position is found.
• This adequate position corresponds to a position in which the portion to be examined 10b of the member 10 of the patient is gripped by the two flexible holding portions 46b and by the two flexible abutment portions 46a.
• peripheral frame 42 makes it possible to ensure the reception of the portion to be examined 10b and of the measuring elements while allowing the tightening of this portion to be examined 10b without significant loss of space.
• other parallelepipedic, cylindrical, oval or similar shapes could also be made.
• the measuring means 40 also comprise a light source 50 such as a laser diode, a receiver 52 such as a photodiode and a calculation unit 54.
• the light source 50 is able to emit light rays of emission towards the portion examining the patient's limb, these emission light rays having predetermined emission characteristics.
• the receiver 52 is for its part capable of receiving the receiving light rays backscattered by the portion to be examined of the patient's limb, these receiving light rays also having predetermined reception characteristics.
• Such measurement means 40 thus make it possible to perform a backscattering measurement during a phase characterized as measuring phase.
• the light source 50 and the receiver 52 may be positioned on either side of the portion to be examined 10a.
• the receiver 52 is then facing the light source 50, integrated on the opposite portion of the peripheral frame 42.
• the receiving light rays correspond to the light emission rays having passed through the portion to be examined 10b of the member 10 of the patient, which corresponds to a measurement by transmission.
• the measuring means 40 also comprise a receiving element 56, in this case a tube, having an outer protective wall 56a defining a protected internal space 56b.
• the light source 50 as the receiver 52 are positioned at least partly within the protected internal space.
• this receiving element 56 is arranged between and moves with the two flexible holding portions 46b which hold it in position.
• the computing unit 54 which is electrically connected to the light source 50 and the receiver 52 can be inside the protected internal space 56b also or in a separate protective housing. This calculation unit 54 makes it possible to compare the emission characteristics of the emission light rays with respect to the receiving characteristics of the receiving light rays.
• this computing unit 54 can generate, by optical detection of one or more constituent (s) of the blood, a measured signal corresponding to the measurement signal generated by the measuring means 40 during the compression phase.
• the measured signal is thus characteristic of the arterial pulsation in the portion to be examined 10b when the latter is subjected to the measurement pressure.
• This embodiment is advantageous because insofar as the measured signal is generated during the compression phase, it is not necessary to correlate it with the evolution of the pressure.
• the compression body 20 and the compression means 30 are structurally independent of the measuring means 40. Indeed, nothing structurally connects the compression body 20 and these compression means 30 to the measuring means 40.
• To implement the screening tool 2 it is therefore first necessary to compress the portion to be compressed 10a through the compression body 20 and the compression means 30, then activate the measuring means 40 and maintain the compression means 30 long enough for the signal measured during this compression phase to allow the calculation means 60 to generate a diagnostic signal.
• a prior measurement - before compression - can be performed to ensure the proper functioning of the screening tool.
• It can also be provided to connect the compression means 30 to the measuring means 40 so as to transmit an activation signal to these measuring means 40 when the pressure threshold value is reached.
• the measuring means 40 can be activated automatically when and as long as the portion to be compressed 10a is compressed as it should.
• the screening tool 2 also comprises calculation means 60 connected to the measuring means 40 and able, from the signal measured during the compression phase, to emit a negative diagnostic signal when the arterial pulse in the portion to be examined is greater than a diagnostic threshold value and to emit a positive diagnostic signal when this arterial pulse is below this diagnostic threshold value.
• these calculation means 60 are able to deduce from the signal measured during the compression phase a useful signal characteristic of the arterial pulsation in the portion to be examined 10b of the patient's limb 10.
• the measurement signal - which is composed of a pseudo-continuous parasitic component and a useful component having a measurement voltage characteristic of the arterial pulsation - is analyzed by the calculation means 60.
• These calculation means 60 comprise a high-pass filter of cut-off frequency equal to 1 Hz so as to annihilate the pseudo-continuous parasitic component of the measurement signals as well as an operational amplifier capable of amplifying the measurement voltage of the useful component.
• the calculation means 60 are able to compare the amplified measurement voltage with a predetermined comparison threshold voltage, so as to obtain a comparison voltage presenting:
• diagnostic signals can then be transmitted to expression means 70 corresponding, for example, to a source of sound emission.
• the expression means 70 when the calculating means 60 emit a negative diagnostic signal, the expression means 70 emit a sound signal whereas when the calculation means 60 emit a positive diagnostic signal, the expression means 70 do not emit sound signal.
• the negative diagnostic information - corresponding to an absence of anomaly - is a periodic emission of sound signal while the positive diagnostic information - corresponding to the presence of an anomaly - is an absence of emission sound signal.
• other luminous, vibrating, or similar expression means 70 could also be contemplated.
• FIGS. 7, 8a and 8b illustrate a second embodiment of a screening tool 102 according to the invention, in which the compression body 120 is formed by an inflatable sleeve 122 made of a flexible and atraumatic material such as silicone. .
• This inflatable sleeve 122 has a first end, a second end and an inner face, said contact surface 124, intended to bear on the portion to be compressed 10a of the member 10 of the patient.
• the inflatable sleeve 122 comprises hooking means 126 arranged on its two ends which allows to hold them hooked to one another. These attachment means 126 correspond, for example, to two complementary portions of Velcro® fabric.
• the inflatable sleeve 122 has a length sufficient to surround the portion to be compressed 10a of the member 10 of the patient and a width greater than 2 millimeters, preferably equal to 25 millimeters.
• the contact surface 124 comes into non-point or quasi-point contact with this portion to be compressed 10a, without traumatizing it but so as to compress it substantially. homogeneous, without causing discomfort to the patient.
• the inflatable sleeve 122 has an outer and peripheral wall 122a, a fluid inlet 122b corresponding to a structural and functional opening made in the outer and peripheral wall 122a and an inner chamber 122c delimited by the outer and peripheral wall and adapted to contain, hermetically, a fluid introduced into the inner chamber 122c via the fluid inlet 122b.
• the screening tool 102 also comprises compression means 130 capable of compressing the contact surface 24 of the inflatable sleeve 122 against the portion to be compressed 10a.
• compression means 130 comprise a discharge member 132 capable of generating a flow of fluid and transfer means 134 able to transport the fluid from the discharge member 132 and up to the fluid inlet 122b of the compression body 120 so as to effect a transfer of the fluid from the compression means 130 and to the inner chamber 122c of the inflatable sleeve 122, through this fluid inlet 122b.
• the discharge member 132 shown in Figure 6 consists of a bellows (or pear). But alternatively, this delivery member 132 could also be constituted by any other similar system, such as a pump, for rapidly inflating the inner chamber 122c of the inflatable sleeve 122.
• the inflatable sleeve 122 used may be disposable and replaced for each new screening operation.
• the compression means 130 it is possible to use the compression means 130 several times but to systematically replace the inflatable sleeve 122.
• the compression means 130 further comprise a calibrated valve 136 capable of releasing a portion of the fluid from the inner chamber 122c of the inflatable sleeve 122 as long as said fluid generates in the interior chamber 122c a measurement pressure greater than a threshold value predetermined pressure.
• the compression means 130 it is first necessary to grip the inflatable sleeve 122 around the portion to be compressed 10a and to hook the first and second ends through the attachment means 126.
• this position is called the relaxation position because the inflatable sleeve 122 is deflated.
• the discharge member 132 it is necessary to actuate, manually or automatically, the discharge member 132 so as to achieve a transfer of fluid - often air - to the inner chamber 122c to inflate, until it reaches or exceeds the predetermined pressure threshold value.
• the calibrated valve 136 is responsible for discharging a portion of this fluid to substantially reach the predetermined pressure threshold value during a compression phase.
• the inflatable sleeve 122 when it is inflated, it is called tension position. In the tension position, the contact surface generates on said portion to be compressed 10a a measurement pressure substantially equal to a previously determined pressure threshold value, and this throughout the measurement phase. It is, moreover, possible thanks to the calibrated valve 136 to adjust precisely, simply, and without risk of subsequent disordering the pressure threshold value sought.
• This pressure threshold value can be between 30 and 80 mmHg (millimeters of mercury), depending on the screenings to be performed.
• the calibrated valve 136 is capable of passing from a first state in which the pressure threshold value corresponds to a first predetermined threshold value to a second state in which the pressure threshold value corresponds to a second predetermined threshold value. In this way, the screening tool 102 can, simply and without incurring additional costs, perform two diagnoses under different measurement conditions.
• the compression means can be obtained by any other appropriate technique. More particularly, the compression means could consist, rather than introducing a fluid into the inner chamber 122c of the inflatable sleeve 122, to suck a fluid from the inner chamber 122c of the inflatable sleeve 122. Such aspiration could allow, depending on the geometry inflatable sleeve 122, to generate a vacuum in the inner chamber 122c and thus deform the inflatable sleeve 122 so as to compress the portion 10a to compress the member 10 of the patient. According to the embodiment of FIGS.
• the second embodiment of the screening tool 102 also comprises measuring means 140 able to cooperate structurally and functionally with the portion to be examined 10b of the member 10 of the patient.
• These measuring means 140 also comprise a light source 150 such as a laser diode, a receiver 152 such as a photodiode and a calculation unit 154.
• the light source 150 is able to emit light emission rays towards the portion examining 10b of the patient's limb 10, these emission light rays having predetermined emission characteristics.
• the receiver 152 is for its part capable of receiving the receiving light rays backscattered by the portion to examine 10b of the member 10 of the patient, these receiving light rays also having predetermined reception characteristics.
• Such measuring means 40 therefore make it possible to perform a backscattering measurement during a phase characterized as measuring phase.
• the measuring means 140 comprise a receiving element 156, in this case a protective shell, having an external protective wall 156a delimiting a protected internal space 156b.
• the light source 150 and the receiver 152 are positioned at least partly inside the protected internal space 156b.
• This receiving member 156 is arranged against the contact surface 124 of the inflatable sleeve 122 and may alternatively be permanently fixed on this inflatable sleeve 122, which ensures optimal positioning or be detached from this inflatable sleeve and placed in position by the the user, which allows to dispose more freely, especially in the case of an inflatable sleeve 122 disposable.
• the measuring means 140 also comprise a receiving element 156 having an external protective wall 156a delimiting a protected internal space 156b in which the light source 150 and the receiver 152 are arranged.
• the receiving element 156 is not arranged against the contact surface 124 of the inflatable sleeve 122 but against the inner face of the outer and peripheral wall 122a, in the inner chamber 122c of this inflatable sleeve 122a.
• the information transmitted by the measuring means 140 may be transmitted by a radio transmission unit 158.
• the compression body 130 and the measuring means 140 are arranged such that the portion to be compressed 10a corresponds at least partially to the portion to be examined 10b. However, this might not be the case for the example in Figure 8a.
• a computing unit 154 is connected by electrical connection to the light source 150 and to the receiver 152 and is also inside the light source. protected internal space 156b or, alternatively, outside this protected space 156b.
• this computing unit 154 makes it possible to compare the emission characteristics of the emission light rays with respect to the receiving characteristics of the receiving light rays.
• this computing unit 154 can generate, by optical detection of one or more constituent (s) of the blood, a measured signal corresponding to the measurement signal generated by the measuring means 140 during the compression phase. The measured signal is thus characteristic of the arterial pulsation in the portion to be examined 10b when the latter is subjected to the measurement pressure.
• This embodiment is advantageous because insofar as the measured signal is generated during the compression phase, it is not necessary to correlate it with the evolution of the pressure. It should be emphasized that according to this embodiment, the compression body 120 and the compression means 130 are functionally independent of the measuring means 140. Indeed, no electrical connection does not connect this compression body 120 and these compression means 130 to the measuring means 140. To implement the screening tool 102, it is therefore first necessary to compress the portion to be compressed 10a by the through the compression body 120 and the compression means 130, then activate the measuring means 140 and maintain the compression means 130 long enough for the signal measured during this compression phase to allow the calculation means 160 to generate a diagnostic signal. In addition, a prior measurement - before compression - can be made to ensure the proper functioning of the mechanism.
• the measuring means 140 may be provided to connect the compression means 130 to the measuring means 140 so as to transmit an activation signal to these measuring means 140 when the pressure threshold value is reached.
• the measuring means 140 can be activated automatically when and as long as the portion to be compressed 10a is compressed as it should.
• the screening tool 102 also comprises calculation means 160 connected to the measuring means 140 by any suitable wired or wireless transmission element. These calculation means 160 are able, from the signal measured during the compression phase, to transmit a negative diagnostic signal when the arterial pulse in the portion to be examined is greater than a diagnostic threshold value and to emit a diagnostic signal. positive when this arterial pulse is below this diagnostic threshold value.
• these calculation means 160 are able to deduce from the signal measured during the compression phase a useful signal characteristic of the arterial pulsation in the portion to be examined of the patient's limb.
• the measurement signal which is composed of a pseudo-continuous parasitic component and of a useful component having a measurement voltage characteristic of the arterial pulsation is analyzed by the calculation means 160.
• These calculation means 160 comprise a high-pass filter of cut-off frequency equal to 1 Hz able to annihilate the pseudo-continuous parasitic component of the measurement signals and then an operational amplifier capable of amplifying the measurement voltage of the useful component.
• said calculating means 160 then compare the amplified measurement voltage with a predetermined comparison threshold voltage, so as to obtain a comparison voltage presenting:
• diagnostic signals are then further analyzed by the calculating means 160 to determine, in a predetermined time interval, the number of negative diagnostic signals corresponding to the "1" state that has been received. . If this number is greater than a standard pulsation number, the calculation means emit a negative diagnostic signal corresponding to a absence of anomaly identification. Conversely, if this number is less than a standard pulsation number, the calculation means emit a positive diagnostic signal corresponding to an anomaly identification. Said diagnostic signal is then transmitted to means of expression 170 composed of a green light-emitting diode 170a and a red light-emitting diode 170b. On receipt of a negative diagnostic signal, the expression means 170 activate the green color diode 170a.
• the expression means 170 activate the red color diode 170b.
• Such means of expression 170 have the advantage of being better understood by a non-specialized user. However, other bright, vibrating, or similar expression means 70 could also be contemplated.
• FIGS. 8 and 9 illustrate a third embodiment of a screening tool according to the invention similar to the second embodiment presented above but in which the measurement means operate by transmission and not by backscatter.
• the measuring means 140 are able to cooperate structurally and functionally with the portion to be examined 10b of the member 10 of the patient.
• These measuring means 140 comprise a light source 150 such as a laser diode, a receiver 152 such as a photodiode and a calculation unit 154.
• the light source 150 is able to emit light emission rays towards the portion examining 10b of the patient's limb 10, these emission light rays having predetermined emission characteristics.
• the receiver 152 of this third embodiment is, for its part, capable of receiving the light receiving rays that have passed through the portion to be examined 10b of the patient's limb 10.
• the receiver 152 is arranged in a separate receiving element 156 and structurally independent of the receiving element 156 comprising the light source 150.
• these receiving elements 156 are arranged inside the inflatable sleeve 122 - or possibly outside this inflatable sleeve 122 - so that, in the use position, the light source 150 emit light emission rays towards the receiver 152.
• the light source 150 and the receiver 152 being separated from each other, each of the receiving elements may also comprise a computing unit 154 and a communication unit 155 allowing the light source 150 and the receiver 152 to communicate with each other and / or with the calculation means 160.
• one or other of the first, second and third embodiments described above may comprise heating means capable of maintaining or raising in temperature at least a portion of the member. of the patient. These means of Thus, heating may be used to maintain or elevate all the patient's limb 10 or simply one and / or the other of the portions to be compressed 10a and examined 10b. These heating means may also comprise a temperature probe capable of measuring the temperature near the portion to be covered by the patient.
• heating means can be made by means of a single piece of clothing - single use or not - such as a sock covering the entire foot, for example, or a pocket containing a heat transfer fluid suitable for rise in temperature under the effect of a thermal activation signal, or else any other equivalent means.
• the heating means correspond to a piece of clothing
• the latter may be formed from a thermally insulating fiber so as to maintain or elevate the temperature or the effective portion (s) ) covered with the member 10 of the patient.
• Said piece of clothing may, in addition, be able to isolate the big toe from the other toes of the patient and integrate the temperature probe, the compression body 20, 120, the compression means 30, 130 and / or the means of measure 40, 140.
• the invention also extends to an embodiment in which the measuring means 40 described with reference to the first embodiment illustrated by FIGS. 1 to 5 are used, on the one hand, and, on the other hand, an inflatable sleeve 122 such as that described with reference to the second and third embodiments illustrated in FIGS. 7 to 10. Said inflatable sleeve 122 could then be fixed permanently, directly or indirectly, on the inner face of the peripheral wall 42 and constitute, partially or completely, the contact surface.

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• 2010
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• 2011
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