CN100563553C - Armarium - Google Patents
Armarium Download PDFInfo
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- CN100563553C CN100563553C CNB200580045302XA CN200580045302A CN100563553C CN 100563553 C CN100563553 C CN 100563553C CN B200580045302X A CNB200580045302X A CN B200580045302XA CN 200580045302 A CN200580045302 A CN 200580045302A CN 100563553 C CN100563553 C CN 100563553C
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- armarium
- pick
- substrate
- communication means
- telemetric communication
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- Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
Abstract
The invention provides a kind of armarium that implants, it comprises: by the substrate that the material that can serve as active sensing material is made, and this activity sensing material sensing and physiology or relevant clinically parameter; At least one pick off, its sensing and physiology or relevant clinically parameter, each pick off comprise the part of the substrate that is configured to serve as active sensing material; And with the telemetric communication means of described at least one sensors coupled, this telemetric communication means will be given remote equipment with the transfer of data of the relating to parameters of at least one pick off sensing in the mode of remote measurement.
Description
Technical field
The present invention relates to implantable armarium, especially but relate to heart valve devices and implant thereof never exclusively.
Background technology
With being implanted into the implantable devices that the relevant telemetry of the patient of equipment transmits with body is known.US2002/0072656A1 and US6, the vascular system of the implanted individuality of 409,675 (its content is incorporated herein by reference) disclosed instruments, and this instrument can provide the information with the important clinical relating to parameters.Other prior art relevant with live data collection in the body comprises patent US6,667,725,6,486,588,6,729,336,6,645,143,6,658,300,5,967,986,6,743,180 and 6,592,518; Patent application US2003/0136417; International monopoly open WO03/061467, WO03/061504 and WO04/014456, and we the time pending trial International Patent Application PCT/GB2004/004661, above-mentioned all contents are incorporated herein by reference.
Summary of the invention
The present invention provides improved implantable armarium at least some of its embodiments, the scope that this equipment is easy to process, produce economy, can be used for clinical design more effective and more easily.
For fear of doubt, term used herein " patient " and " health " had both comprised in its scope that the mankind also comprised animal.
According to a first aspect of the present invention, it provides a kind of armarium that implants, and this equipment comprises:
By the substrate that the material that can serve as active sensing material is made, this activity sensing material is used for sensing and physiology or relevant clinically parameter;
At least one sensing and physiology or the pick off of relevant parameter clinically, each pick off comprise the part of the substrate that is configured to serve as active sensing material; And
With the telemetric communication means of described at least one sensors coupled, this telemetric communication means with the mode of remote measurement will with the transfer of data of the relating to parameters of at least one pick off sensing to remote equipment.
Telemetric communication means can comprise at least one antenna.
Preferably, telemetric communication means is at least partially disposed on the substrate.In some embodiments, telemetric communication means integral body is arranged on the substrate.
In a preferred embodiment, antenna is arranged on the substrate.
In selectable embodiment, this equipment also comprises an additional substrate, is formed with antenna on this additional substrate, and additional substrate contacts with the substrate that is made of the material that can serve as active sensing material.
Preferably, substrate is flat basically, perhaps from planar structural bending basically.These structures all are used in particular in the vivo applications.
In preferred embodiment, a face of substrate is provided with ground plane.Be easily, at least one pick off is arranged on the front of substrate, and ground plane is arranged on the back side of substrate, so that ground plane extends on a zone at least, this zone and the regional alignment that limits by at least one antenna, and ground plane preferably additionally extends in a zone, this zone and regional alignment by a sensor definition.This structure both can provide advantage with operating in the structure of pick off, also can provide advantage on the efficient of telemetric data communication.Be that ground plane is arranged on the whole back side of substrate basically easily.
According to a preferred aspect of the present invention, armarium be fit to be implanted patient's heart, and it can be at this i) move as cardiac valve; Perhaps ii) auxiliary one of them valvular function of patient; Perhaps iii) one of them valvular function of monitored patient:
At above-mentioned option i) situation under, armarium is a kind of cardiac valve, this cardiac valve can also comprise the valve that is used for regulating through the blood flow of this equipment.Typically, though the present invention without limits, this valve comprises a plurality of blades.
Under above-mentioned option situation ii), armarium can comprise a valvular repair apparatus.This valvular repair apparatus can comprise a valvular supporting construction, for example an annular supporting construction.This annular supporting construction can be sewn onto on the cardiac valve that the patient loses function.
Under above-mentioned option situation iii), armarium can comprise that one is fit to be placed in the patient's heart valve or the structure on the valve.Patient's cardiac valve can be the intrinsic valve of handling, though perhaps do not handle, can require to monitor and decide the processing that when or whether to need other or reset.
This armarium can be a kind of tissue valve device, and it has a valve wall by organizational composition.This armarium can have support or not have support.Especially, this armarium can also comprise the support that supports valve wall, and wherein, at least one pick off and telemetric communication means are arranged between support and the valve wall.
The armarium of tissue valve prosthesis can also comprise a protective cover that is provided with around equipment periphery, and at least one pick off and telemetric communication means are arranged between valve wall and the protective cover.Protective cover can comprise the polymer layer such as terylene (RTM), and perhaps a pericardial layer typically, is crosslinked.
Armarium can be a Cardiac valve prosthesis.
Selectively be that armarium can be graft or support or link to each other with graft or support.
By for example suitable mode of stitching or adhesive, this equipment can link to each other with required body part.In preferred embodiment, armarium is a kind of form of suitable injection health.The term form of health " be fit to inject " means that this equipment can introduce health with acceptable manner clinically at least, for example passes through endoscope.Use less injection device, for example the armarium that be fit to inject is provided is possible to hypodermic needle.
In other embodiment of the present invention, armarium is an artificial heart or a left ventricle fastening (LVad).These equipment comprise artificial heart valve.Substrate, pick off and telemetric communication means might be arranged on the artificial heart valve, perhaps selectively are, substrate, pick off and telemetric communication means can be arranged in the equipment or other place on the equipment.
In a preferred embodiment, telemetric communication means is a kind of inactive component.For example, this equipment can provide power by the energy of remote equipment emission.
Telemetric communication means can be a transponder such as the RF marking arrangement, and it also can be called radio frequency identification equipment (RFID).The use of these equipment is very economical.Same, these equipment can provide useful information easily, for example the position of the record of the original performance data of equipment, device type, equipment insertion, process details or the like.
Armarium can also comprise a capacitor and be used for receiving the outside energy that uses and utilize the device of the energy of this outside use to described capacitor charging that wherein, telemetric communication means and/or pick off provide power by the electric charge that stores in the capacitor.For example, can use outside radio frequency source to charge to capacitor, this capacitor will be step by step to telemetric communication means and/or pick off discharge and improve its power.Control device can control capacitor begin to provide power to telemetric communication means and/or pick off.Control device causes capacitor in the discharge of time of needs, and this time can be the scheduled time, or control device receives the time of the control signal of sending from the equipment of health outside, and the control signal of being sent for example is suitable radiofrequency signal.
Selectively be, telemetric communication means can provide power by the energy source such as battery, and this energy source is arranged on the armarium, and perhaps the mode with physics is connected with armarium.
Selectively be, also may utilize the energy that is produced by the patient, especially with the beating or energy that other body function is relevant of patient's heart, these energy change pressure provide power to telemetric communication means.In these embodiments, armarium can also comprise the device that a capacitor and the utilization energy relevant with physiological activity charge to described capacitor, and wherein, telemetric communication means and/or pick off provide power by the electric charge of capacitor stores.Preferably, the device to described capacitor charging comprises a piezoelectric device, for example poly-inclined to one side two fluorine ethylenes (PVDF) piezoelectric device.By inherent fluctuation pressure in the blood of conversion heart conveying, this piezoelectric device can produce essential electric charge.Control device can be controlled the discharge that the capacitor of power is provided to telemetric communication means and/or pick off.Control device causes capacitor in the discharge of time of needs, and this time can be the scheduled time, or control device receives the time of the control signal of sending from the equipment of health outside, and the control signal of being sent for example is suitable radiofrequency signal.Utilize the energy relevant also may be used as pick off to the device of described capacitor charging with physiological activity.In this respect, piezoelectric transducer is particularly useful.
Telemetric communication means can provide power by the RF field.
Telemetric communication means can be utilized RF field transmission data.
Telemetric communication means can be transmitted data by alternate manner, and/or provides power by alternate manner, and these alternate manners are microwave or other electromagnetic radiation, acoustical signal or other electromagnetic field for example.
In other embodiments, telemetric communication means, the device that uses by telemetric communication means transmission data and provide the device of power can utilize the known technology in mobile phone (being also referred to as the battery phone) field to telemetric communication means.In these embodiments, telemetric communication means can be utilized bluetooth (RTM), WLAN, GSM, GPRS or UMTS technical transmission data.
Telemetric communication means can comprise integrated circuit.
Integrated circuit can be arranged on the substrate, perhaps selectively is arranged on the additional substrate.
Telemetric communication means can comprise a chip, preferably includes a microchip.
At least one pick off can be the pressure transducer of sense blood pressure.By this way, unusual Xiang Guan clinical pressure data, such as heart contraction and diastole pressure, and the relation curve of pressure relative time can obtain.In addition, can check out seepage by checking that pressure changes.Can check out easily by this way from leakage such as the blood vessel implant of blood vessel graft.Advantageously, this armarium comprises the pressure transducer that at least two intervals separate, the blood pressure at these pick off sensing diverse location places, for example blood pressure at sensing patient's heart diverse location place.In this case, telemetric communication means can remote measurement the ground transmission with by the relevant data of the blood pressure difference of at least two pressure sensor senses.Can obtain the information of relevant blood flow and blood seepage by this way, especially through the pressure differential of valve or valve alternative ,/narrow/insufficient relevant useful data narrow with valve is provided.The pressure data that can obtain comprises the instantaneous pressure data.In addition, can calculate instantaneous blood flow velocity.
At least one pick off can be the sonic transducer of acoustic signals.Can obtain the very relevant clinical data relevant by this way with heartbeat.Especially, consider any abnormal rhythm and pressure curve so, can estimate the performance of heart valve repair, above-mentioned pressure curve can influence the deciphering of the acoustical signal of the valve performance that remote measurement produces.In addition, no matter blood flow is normal or undesired, can obtain the information relevant with blood flow.
Be that one or more pick off comprise the pressure transducer of at least one sense blood pressure and the sonic transducer of at least one acoustic signals easily.Blood pressure, pressure curve and pressure differential can obtain sensing.Signal transducer can sense blood pressure and acoustical signal.
One or more pick off can sensing other physically relevant parameter, for example temperature, pH, biochemical parameters, CO
2And O
2
At least one pick off can be a passive sensor, that is to say, this pick off does not need power source during as operating sensor.
At least one pick off can be a piezoelectric transducer.Substrate can be made by the polymeric material that can serve as the active piezoelectric sensing material.Polymeric material can comprise polyvinylidene fluoride (PVDF) or relevant PVDF material.Since might provide can monitor force again can the monitored sounds signal the PVDF pick off, so PVDF is a kind of preferable material.Relevant PVDF material comprises the copolymer with PVDF, for example PVDF-trifluoro-ethylene (TrFe) copolymer.Other materials that can serve as the active piezoelectric sensing material comprise the mixture of pottery and ceramic/polymer.
Because in the reality, if equipment can be crooked, the replacement meeting of the vivo applications of equipment is very simple so, so substrate preferably made by deformable material, for example the mixture of polymer or ceramic/polymer.
At least the part of armarium can scribble non-thrombinogen or antiprothrombin, biocompatible material.Especially, can smear one or more pick off by this way.
One or more pick off and telemetric communication means are salable in biocompatible protection structure.This protection structure can scribble non-thrombinogen or antiprothrombin, biocompatible material.
According to a second aspect of the present invention, the armarium that implants that is provided comprises:
Substrate or comprise the substrate stack of a plurality of stack substrates, substrate or substrate stack have relative first and second;
At least one pick off, it is arranged on and is used for sensing and physiology or relevant clinically parameter on substrate or the substrate stack;
Telemetric communication means with at least one sensors coupled, its be used for the mode of remote measurement will with give remote equipment by the transfer of data of the parameter correlation of at least one pick off sensing, this telemetric communication means comprises the antenna that at least one is provided with on substrate or substrate stack first; And
Ground plane, it is arranged on substrate or substrate stack second, and extends on a zone with the regional alignment that is limited by at least one antenna at least.
Typically, telemetric communication means or whole or partly be arranged on substrate or the substrate stack.A second aspect of the present invention can be in conjunction with the feature of first aspect present invention.
According to a third aspect of the invention we, the system of monitored patient of being used for that is provided comprises:
Armarium according to the bright first aspect of this law, second aspect or the 5th aspect; And
Remote equipment, it receives by the data of telemetric communication means with the remote mode transmission.
One important aspect, the invention provides a kind of system that is used for monitored patient, it comprises the armarium according to second aspect present invention, and receives by the remote equipment of telemetric communication means with the data of remote mode transmission; Wherein, remote equipment comprises at least one data reception antenna and a ground plane, this ground plane extends on a zone with the regional alignment that is limited by at least one data reception antenna at least, has therefore improved by the reception of armarium with the data of remote mode transmission.
Remote equipment can be fit to provide to telemetric communication means the power of far-end.For this purpose, remote equipment can be suitable for producing the RF field.
The present invention comprises in its scope provides one or more trunking.In this embodiment, trunking receives the data by the telemetric communication means transmission, and sends these data to remote equipment or another one trunking.The implantable intravital appropriate location of trunking.If telemetric communication means only has a short range, that trunking just is even more important.
Equipment of the present invention can be used for application, urinary system, digestive system, the intensive care monitoring of heart, other organs, blood vessel, lung, orthopedic application, neurosurgery and has transplant organ such as kidney, liver or heart, for example estimate to become a mandarin and the difference of the flow and the pressure of the pipe that goes out to bleed, and in view of the above as the refusal treatment or in response to the guidance of treatment.Nonrestrictive embodiment comprises armarium is used for abdomen aneurysm (AbdominalAortic Aneurysm) treatment and/or monitoring (AAA), is under a kind of situation of AAA graft at armarium especially.Blood vessel can be tremulous pulse and vein, and tremulous pulse for example is pulmonary artery and large artery trunks.The use of intensive care monitoring comprises armarium of the present invention is placed on such as one or more position on pulmonary artery and the aortic blood vessel, with for example when the opening operation or measure cardiac output and filling pressure afterwards, these operational example are as being the operation of heart and lung.This equipment also can be used for the patient and have non-surgical situations under the life danger situation, for example wound, heart failure or septicemia.Orthopedic application comprises the use on ligament and the joint, for example on joint capsule or such as using in hip or the kneed substitute, the pressure/strain at hip and knee joint place is important accretion measure.The application of neurosurgery comprises intracranial pressure and the hydraulic measurement of spinal column.Equipment of the present invention can be arranged on the brain thin film (meninges).The use relevant with lung comprises the inspection of airway obstruction, is particularly useful for asthma cases, and also measures asthma cases and the reaction of other pneumonopathy to medicine.For example the pneumonopathy of emphysema, chronic bronchitis and other forms of restricted airway disorders can be monitored.The use of urinary system comprises the measurement of bladder pressure, ureter flow or capacity of returns and urine amount.Other use relates to the repairing of valve and the endarterectomy after the carotid artery repairing.Under a kind of situation in back, the carotid artery flow can be measured, and this equipment can be sewn to the appropriate location.ECG measures and can carry out.Other preferably use the present invention and comprise the use relevant with support and blood vessel graft.Blood vessel graft can be used support or not use support.They itself can comprise support or blood vessel graft armarium of the present invention, perhaps selectively are, armarium can be arranged on support or the blood vessel graft, the inside or near.This armarium can be for example by leak check or the narrow performance of whether monitoring support or blood vessel graft, and perhaps whether estimating stent or blood vessel graft move.That the unrestricted example of support comprises is pulmonary, blood vessel, heart, the support of breast and abdominal part.The limiting examples of graft comprise AAA, infra-inguinal, Gu popliteal (femoral popliteal), distal femur, vein and the approaching graft (vascular access graft) of blood vessel.Blood vessel comprises for the graft of needs of patients dialysis and the graft of department of pediatrics cardiac catheter near the example of graft.The measurement of digestive system can especially be carried out for example pH and pressure at esophagus, harmonization of the stomach enteral.
According to a forth aspect of the invention, its a kind of pick off that provides comprises the material that can serve as active sensing material, and the electrode that on material, forms with antenna pattern, so this pick off i) material is worked as active sensing material, and ii) serve as the signal that antenna transmits and/or reception is relevant with operating sensor.
Preferably, this material is a kind of material that can serve as active piezoelectric material.Advantageously, this material is a kind of polymeric material, is preferably PVDF.
Antenna pattern (it is typically spiral-shaped) stays one or more gap between adjacent electrode part is divided, and preferably, to such an extent as to this gap minimizes the antenna active region of cladding material as much as possible.In general, wish the gap,, be most preferably about 10 μ m preferably less than 25 μ m less than 50 μ m.
Advantageously, pick off also is included in the ground plane that forms on the material, this ground plane at least with the material area of the regional alignment that limits by electrode on extend.
This pick off can be used for multiple application.In a preferred application, pick off is the form of the armarium that is fit to implant, wherein, this pick off is used for sensing and physiology or relevant clinically parameter, and electrode will be given remote equipment with the transfer of data of the relating to parameters of pick off sensing in the mode of remote measurement.
Pick off can be in conjunction with the feature of first aspect present invention and second aspect.
According to a fifth aspect of the invention, its armarium that implants that provides comprises:
At least two pick offs, its sensing and physiology or relevant clinically parameter;
Differential measuring apparatus, the difference in its measuring transducer response; And
Telemetric communication means, itself and differential measuring apparatus are coupled, and are used for giving remote equipment in the mode of remote measurement with the transfer of data relevant with the difference in the pick off response.
Differential measuring apparatus can comprise a kind of bridge circuit such as Wheatstone bridge.
Differential measuring apparatus can comprise a kind of differential amplifier.
By this way, variate just can directly be transmitted by equipment.In preferred embodiment, differential pressure and/or sound measurement can so transmit, to such an extent as to for example can obtain measuring through the pressure of leaflets and/or the difference of sound.Be that the interferential influence that pick off is responded can be compensated in addition or selectively.
The equipment of fifth aspect present invention can be in conjunction with the feature of the present invention first, second or fourth aspect.
Description of drawings
Embodiment according to armarium of the present invention and system describes with reference to the accompanying drawings, wherein:
Fig. 1 has showed the plane graph (a) and the side view (b) of armarium first embodiment;
Fig. 2 has showed the plane graph of armarium second embodiment;
Fig. 3 has showed the plane graph of armarium the 3rd embodiment;
Fig. 4 has showed the plane graph of armarium the 4th embodiment;
Fig. 5 has showed a kind of device that leaflets is carried out variate that passes;
Fig. 6 has showed the setting of two equipment, and these equipment pass implantable tissue heart valve;
Fig. 7 has showed a kind of device at implantable armarium and reading device back use ground plane;
Fig. 8 has showed the exploded view of armarium the 5th embodiment;
Fig. 9 has showed the plane graph of armarium the 6th embodiment;
Figure 10 has showed a kind of differential sense measuring device.
The specific embodiment
Fig. 1 to 5 has showed the various embodiments according to armarium of the present invention.Among these figure each has all been showed antenna with concentric circular and oval form semi-schematic ground.Will be appreciated that these concentric circulars and the oval helical geometry of representing that actual antennas is required of all being intended to.Fig. 1 has described first embodiment of armarium, and mainly the armarium by 10 indications comprises a substrate 12, and substrate is made by the material with piezoelectric activity.Substrate 12 can have any shape and size easily.First face of substrate 12 is provided with telemetric communication means 14,16 and piezoelectric transducer 18.Telemetric communication means comprises an integrated circuit 16 with antenna 14 communications.Integrated circuit 16 also has the interconnection 20 with piezoelectric transducer 18, for example gold thread.If desired, other circuit, for example buffer amplifier and digital-analog convertor and the interconnection that is associated can be used on the substrate 12.For example an electrode 18a is set on the subclass of substrate 12 and just can constitutes piezoelectric transducer 18 by metallized method.Piezoelectric transducer can be played in the zone of having only substrate 12 to be positioned at below the electrode 18a, and piezoelectric transducer can for example be used for the sensing of relevant sound and/or pressure.The zone of every other substrate 12 is all inoperative to piezoelectricity basically.The face that the face of the substrate of showing with Fig. 1 (a) 12 is opposite is a ground plane 22.Metal material by a kind of for example gold of deposition on substrate 12 surfaces can form ground plane 22.Although in fact do not need, preferably, ground plane is arranged on whole of substrate 12.Or rather, ground plane should form in one or more specific region of substrate 12.Ground plane 22 extension below piezoelectric transducer 18 will be appreciated that, on substrate 12 upper faces, the part that only is positioned on the substrate 12 below the electrode 18a is supported by bar in the mode of electric power, makes it become active piezoelectric.Except piezoelectric transducer in service helpful, ground plane 22 plays adjection in the operation that improves antenna 14.Interconnection between the front and back of substrate 12, for example 16 interconnection can be by the through hole on the plating substrate 12 or by using small-sized rivet to realize from ground plane 22 to integrated circuit.
Preferably, substrate 12 is made by PVDF.One of advantage of PVDF (and other polymeric piezoelectrics) is that it can be shaped to a certain extent, thereby substrate can stand bending to a certain degree.Very favourable this use in vivo applications.The advantage of using the PVDF piezoelectric transducer is that it both can be used as pressure transducer and uses, and also can be used as microphone and makes and be used for acoustic signals.Under the pressure transducer pattern, the PVDF pick off can react to blood pressure in cardiac cycle.Under intercom mode, the PVDF pick off can be heard the sound that blood flow is sent when the heart valve.PVDF is found in " the Tactile Sensors for Robotics in Medicine " that was published in 1988 by John G Webster, John Wyley as pressure transducer with as the detailed description that microphone uses, especially the 8th chapter " Piezoelectrics sensors " and Chapman and Hall are in " the TheApplications of Ferroelectric Polymers " of publication in 1988, especially the 8th chapter " Microphones; Headphones and Tone Generators ", foregoing is incorporated herein by reference.The typical thickness of substrate is between 60-150 μ m, preferably between 60-110 μ m.In a preferred embodiment, integrated circuit 16 is a kind of so-called RF marking arrangement (this equipment is also referred to as radio frequency identification equipment (RFID) chip--for example referring to Britain magazine " Computing " January in 2003 16 editions).As everyone knows, this equipment is used for position monitor.For example can use a kind of RF labelling of subcutaneous setting to monitor by this way such as the animal of cattle and house pet.The RF marking arrangement is a kind of inactive component, up to by a kind of suitable and powerful, RF signal inquiry canonical correlation.This signal energy is high enough to power on to the RF marking arrangement, and under the situation of location survey, described signal typically uses the response frequency of about 450MHz, typically in response to the electronic bar code signal of certain form.For the purposes of the present invention, the function of RF labelling is compared slight change with its function in prior art is used.Especially, the RF labelling receives the data that come from pick off, and gives the remote equipment of inquiry with the transfer of data relevant with measurement that obtains with pick off.A method that realizes these is exactly the response of using the signal of pick off to modulate the RF labelling in a suitable manner.Method for optimizing by RF flag transmission data is exactly the ID sign indicating number that comes modified R F labelling by the data that receive in response to pick off.Also it is contemplated that other data transmission method, for example modulate the message transmission rate of RF labelling.Those skilled in the art should expect suitable power estimation and data collection system.Disclose other information relevant with the RF marking operation in International Patent Application WO 02/073523 and the US patent 6622567, this content this paper of two pieces is incorporated herein by reference.
First embodiment that Fig. 1 shows can be used for a plurality of application, for example is used for cardiac valve.Equipment 10 should for example be used for support, half support or unsupported cardiac valve.
Fig. 2 has showed second embodiment of armarium, and this armarium is mainly by 24 indications.Equipment 24 comprises a substrate 26, is formed with the telemetric communication means that 28,30 and one of two pick offs comprise integrated circuit 32 and two antennas 34,36 on the substrate.Relevant with first embodiment 10 basically those of the detailed description of second embodiment, 24 structures are described basic identical.In particular, the ground plane (not shown) forms on a face of substrate 26, and the face that this face and Fig. 2 show is opposite.By two pick offs 28,30 are set, differential measuring system can be provided, for example come measure differences in pressure.Second embodiment 24 shown in Figure 2 should for example be installed on the blood vessel graft.Set two antennas 34,36 should for example be used for independent broadcasting.It also is possible that a embodiment with 28,30 and antennas of two pick offs is provided.
Fig. 3 has showed the 3rd embodiment of present device, and this equipment is mainly by 38 indications.This equipment comprises a substrate 40, and by being formed with an electrode thereon, a part that is arranged in the described substrate in zone 42 is served as a piezoelectric transducer.Equipment 38 also comprises integrated circuit 44 and antenna 46.The ground plane (not shown) forms on the face opposite with the face of substrate 40 shown in Figure 3.The detailed description of the detailed description of equipment 38 operations and structure and the operation of equipment 10 and structure is similar.Equipment 38 is long, the thin relatively rectangular strip forms with relative high aspect ratio.This structure is convenient to be used for valvular downstream part.Equipment 38 can be used for the measurement of pressure and/or acoustical signal.
Fig. 4 has showed the 4th embodiment of present device, and this equipment is mainly by 48 indications.Equipment 48 is somewhat similar with second embodiment shown in Figure 2, and it comprises 52,54, one integrated circuits 56 of 50, two pick offs of a substrate and two antennas 58,60.The main difference of the 4th embodiment and second embodiment is that the 4th embodiment is long, the thin relatively rectangular in form with relative high aspect ratio.This structure is convenient to be installed on the intravascular stent.Provide two pick offs 52,54 can carry out variate, for example carry out the measurement of differential pressure.
Fig. 5 has showed the alternative that a kind of differential wave is measured, and it has used two equipment 62,64 of the present invention.This method is passed in valvular differential pressure and/or the acoustical signal in measurement especially and is had superiority.Valve leaflets 66 illustrates in the mode of signal in Fig. 5.As can be seen, equipment 62 and 64 can be arranged on the either side of valve leaflets 66, and this can judge the valve leaflets function at valve leaflets 66 places.Fig. 6 has showed equipment 62,64 settings with respect to cardiac valve 68.The position of the blade of cardiac valve 68 approximately is positioned on the horizontal plane of dotted line shown in Figure 6.Therefore, there is not a large amount of spaces to come place apparatus 62, thus preferred such as equipment the 3rd embodiment, relative thin.The alignment restrictions of equipment 64 is less, therefore can use such as equipment first embodiment, that have relatively low aspect ratio.Therefore but will be appreciated that under these two kinds of situations, the available volume of housing apparatus is limited, use flat relatively equipment (particularly those to a certain extent can from the equipment of plane deformation) advantageous.One of advantage of the present invention is that such equipment is easy to provide.There are a lot of methods equipment 62,64 can be located with respect to cardiac valve 68.For example, the cover of pericardium can be arranged on the outside of main lobe membranous wall, and equipment 62,64 can be arranged between the cover and main lobe membranous wall of pericardium.
Fig. 8 has showed the 5th embodiment of armarium, and it comprises that one is installed in device on four contact pins 92,94,96,98 with RFID integrated circuit 90 with the form of flip-chip.RFID90 is installed on the substrate 100, and substrate 100 is made such as mylar (Mylar) or other flexible materials by suitable material.Aerial coil 102 also is arranged on the substrate 100.Aerial coil is spiral-shaped, but simple in order to describe, what Fig. 8 showed is round-shaped.Two contact pins 92,94 are used for being electrically connected with aerial coil 102, and simultaneously, a pair of in addition contact pins 96,98 is used for being electrically connected with other two contact pins (not shown), and these two other contact pins are arranged on the back side of substrate 100.Be arranged on contact pins on substrate 100 back sides be used for be arranged on PVDF substrate 108 fronts on contact pins 104,106 be electrically connected.Electrode 110 is arranged on the suitable major part in PVDF substrate 108 fronts, and electrode 110 is so constructed, so it can not arrive the edge of PVDF substrate fully.Contact pins 104 is electrically connected with electricity level 110, and contact pins 106 has a galvanized through hole simultaneously, and this through hole can be electrically connected with the ground plane (not shown) that covers whole PVDF substrate 108 back sides.In order to assemble this equipment, with two substrates 100,108 closely contact of putting together.Outside the zone of the contact pins that needs are electrically connected, use and to accomplish this point, in above-mentioned zone, can use a spot of electroconductive binder such as the non-conductive binding agent of epoxy adhesive.The example that is fit to comprises a kind of epoxy adhesive that is added with silver, perhaps a kind of gold plated polymer spheres, anisotropic electroconductive binder that uses hollow, and sphere diameter typically is 2-3 μ m.The coupling apparatus of finishing this equipment can be operated under vacuum and discharge two air pockets between substrate.The advantage relevant with such device structure mainly contains 2 points: the first, and the PVDF pick off has occupied the quite most of of equipment, and this has improved sensitivity; The second, for given sizes of substrate, aerial coil can be done greatly as far as possible, and therefore this improved the coupling between equipment and the outside reader.The advantage about providing ground plane to bring that discuss in the front also can be suitable for.This equipment is particularly useful for the measurement of pressure and/or sound.
Fig. 9 has showed the 6th embodiment of armarium, and it comprises a PVDF substrate 112, and this substrate top is formed with a metallized antenna 114.The integrated circuit 116 that is preferably RFID is arranged on the substrate 112, and with antenna 114 communications.In this embodiment, single structure 114 had both served as antenna and had also served as the PVDF electrode.The standard method of polarization PVDF can be used.Advantageously, antenna 114 should cover the active region of PVDF substrate 112 as much as possible.Can realize this point by guaranteeing that gap between helical trajectory minimizes, this helical trajectory constitutes antenna 114.The precipitated metal method of use standard might obtain the gap of about 10 μ m.Preferably, this equipment also comprises a ground electrode or a ground plane that covers PVDF substrate 112 whole back side (not shown).Ground plane should link to each other with integrated circuit 116 by a galvanized through hole.Though it is contemplated that different measurements, for example use different materials to measure, this equipment is particularly useful for the measurement of sound and/or pressure.The for example variate of pressure might provide some equipment so if desired, and a wherein independent integrated circuit uses two isolating antennas.Selectively be, can use two complete isolating substrates, wherein each substrate all has the integrated circuit of oneself.Preferably, substrate is made by the material of the active sensing material that serves as pick off.But, utilize an independent electrode inquire/stimulus sensor and the principle of serving as antenna more generally be used for the equipment that those use an independent substrate.
Figure 10 has showed a system with schematic form, and wherein variate can be used for live body.In Figure 10, the output of four pick offs 118,120,122,124 is imported into differential measurement device 126, this equipment 126 provide with pick off response in the relevant output of difference.The output of differential measurement device 126 is transferred to telemetric communication means, and this telemetric communication means preferably includes such as the integrated circuit 128 of a RFID and an antenna 130.Differential measurement device 126 can be a Wheatstone bridge, or any other bridge circuit that is fit to.Pick off 118,120,122,124 can comprise that the front described the top electrodes of the PVDF equipment of type, and the equipment of having described type is divided into four zones that separate.By this way, from such as obtaining bigger vulnerability to jamming the interference of electromagnetic noise.Selectively be that the output of less pick off can link to each other with Wheatstone bridge or other bridge circuits.Still selectively be that for instance, the output of two pick offs can link to each other with differential charge amplifier.By this way, this equipment can be changed between the measurement of the measurement of differential values and absolute sensor value.A kind of like this device is particularly useful for the variate of pressure, and especially preferably about the described device type of Fig. 9, this equipment is provided with two antenna.
If ground plane uses with long-range reading device and implantation equipment, then may obtain other improvement.Fig. 7 has showed the device of expecting with the form of signal, and the device of this expection comprises an implantation equipment 70 and a long-range reading device 72.Implantation equipment 70 comprises an antenna 74 of being supported by ground plane 76.Similarly, reading device 72 comprises an antenna 78 of being supported by ground plane 80.Be that simple in order to explain, other elements of implantation equipment 70 and long-range reading device 72 have all omitted with being to be understood that.Will be appreciated that under the situation of implantation equipment 70 and remote reading equipment 72, antenna and ground plane are arranged on the opposing face of substrate usually.But under the situation of implantation equipment 70, need not make substrate by the same material of making pick off.Typically, approximately separate the 1-2 millimeter between reader antenna and the ground plane.The device that Fig. 7 mainly shows is improving to implantation equipment 70 telemetry communications and from implantation equipment 70 telemetry communications.Not wishing to be subjected to the restriction of any particular theory, can be that these improve the magnetic field coupling that all improves due to trustingly.More effective telemetry communication can be realized, that is to say, can horizontal stable owing to come from the transmission of implantation equipment 70, and therefore when ground plane not only was used for implantation equipment but also is used for long-range reading device, it may penetrate thick biological tissue.
Claims (34)
1, a kind of armarium that implants, it comprises:
By the substrate that the material that can serve as active sensing material is made, this activity sensing material is used for sensing and physiology or relevant clinically parameter;
At least one pick off, its sensing and physiology or relevant clinically parameter, each pick off comprise the part of the substrate that is configured to serve as active sensing material; And
With the telemetric communication means of described at least one sensors coupled, this telemetric communication means will be given a remote equipment with the transfer of data of the relating to parameters of described at least one pick off sensing in the mode of remote measurement.
2, armarium according to claim 1, wherein, telemetric communication means comprises at least one antenna.
3, according to claim 1 or 2 described armarium, wherein, telemetric communication means is at least partially disposed on the described substrate.
4, according to the described armarium of claim 3 that is subordinated to claim 2, wherein, described antenna is arranged on the substrate.
5, armarium according to claim 2 also comprises additional substrate, is formed with described antenna on this additional substrate, and this additional substrate contacts with the above-mentioned substrate of being made by the material that can serve as active sensing material.
6, armarium according to claim 1, wherein, substrate is flat basically, perhaps forms from planar structural bending basically.
7, armarium according to claim 1, wherein, a face of substrate is provided with ground plane.
8, armarium according to claim 7, wherein, telemetric communication means comprises at least one antenna, described at least one pick off is arranged on the front of substrate, and ground plane is arranged on the back side of substrate, so ground plane extends on a zone with the regional alignment that is limited by at least one antenna at least.
9, armarium according to claim 8, wherein, ground plane in addition with zone by the regional alignment of a sensor definition on extend.
10, armarium according to claim 1, wherein, described at least one pick off is a piezoelectric transducer.
11, armarium according to claim 10, wherein, substrate is made by the polymeric material that can serve as the active piezoelectric sensing material.
12, armarium according to claim 11, wherein, described polymeric material comprises PVDF.
13, armarium according to claim 1, wherein, described at least one pick off pressure sensor and/or acoustical signal.
14, armarium according to claim 1, wherein, telemetric communication means is a kind of inactive component.
15, armarium according to claim 14, wherein, telemetric communication means is by the energy energy supply of remote equipment emission.
16, armarium according to claim 1, wherein, telemetric communication means is a kind of transponder.
17, armarium according to claim 1, wherein, telemetric communication means comprises RFID equipment.
18, armarium according to claim 1, wherein, telemetric communication means comprises integrated circuit.
19, armarium according to claim 18, wherein, described integrated circuit is arranged on the described substrate.
20, armarium according to claim 1, this armarium be fit to implant the patient heart and can be at this i) move as cardiac valve; Perhaps ii) assist one of them valvular function of patient; Perhaps iii) one of them valvular function of monitored patient.
21, armarium according to claim 20, wherein, described armarium is a kind of cardiac valve, this cardiac valve is the tissue valve device with the valve wall that is formed by tissue.
22, armarium according to claim 21 also comprises a supporting bracket that is used for valve wall, and wherein, described substrate, at least one pick off and telemetric communication means all are arranged between this supporting bracket and the valve wall.
23, a kind of no support armarium according to claim 21.
24, armarium according to claim 20 also comprises the protective cover that is provided with around the equipment periphery, and wherein, described substrate, at least one pick off and telemetric communication means all are arranged between valve wall and this protective cover.
25, armarium according to claim 20, wherein, described armarium is a kind of Cardiac valve prosthesis.
26, a kind of pick off, it comprises the material that can serve as active sensing material, and the electrode that on this material, forms with antenna pattern, so this pick off i) described material is worked as active sensing material, and ii) serve as the signal that antenna transmits and/or reception is relevant with operating sensor.
27, pick off according to claim 26, wherein, described material is a kind of material that can serve as active piezoelectric material.
28, pick off according to claim 27, wherein, described material is a kind of polymeric material.
29, pick off according to claim 28, wherein, described polymeric material is PVDF.
30, according to any one described pick off of claim 26-29, wherein, described antenna pattern stays one or more gap between the adjacent part of electrode, and described gap is less than 50 μ m.
31, pick off according to claim 30, wherein, described gap is less than 25 μ m.
32, pick off according to claim 31, wherein, described gap is 10 μ m.
33, pick off according to claim 26 also is included in the ground plane that forms on the described material, this ground plane at least with the zone of the described material of the regional alignment that limits by described electrode on extend.
34, pick off according to claim 26, it is the form of the armarium that is fit to implant, wherein this pick off is used for sensing and physiology or relevant clinically parameter, and this electrode will be given a remote equipment with the transfer of data of the relating to parameters of pick off sensing in the mode of remote measurement.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBPCT/GB2004/004661 | 2004-11-04 | ||
| PCT/GB2004/004661 WO2005046467A1 (en) | 2003-11-04 | 2004-11-04 | Medical device for implantation with telemetric sensor |
| GB0428000.4 | 2004-12-21 |
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| Publication Number | Publication Date |
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| CN101094606A CN101094606A (en) | 2007-12-26 |
| CN100563553C true CN100563553C (en) | 2009-12-02 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US8159347B2 (en) * | 2008-09-25 | 2012-04-17 | General Electric Company | Sensors having gap based sensing devices and methods of making and using the same |
| CN104639579B (en) * | 2013-11-11 | 2019-07-12 | 北京大学 | A kind of method and system carrying out sensor network energy transmission using body surface channel |
| WO2017031480A1 (en) * | 2015-08-20 | 2017-02-23 | Cardiac Pacemakers, Inc. | Header core fixation design for an imd |
| CN105832325A (en) * | 2016-06-06 | 2016-08-10 | 任勇 | Renal arterial stent based blood flow speed monitoring device and renal arterial stent based blood flow speed monitoring method |
| CN105832312A (en) * | 2016-06-06 | 2016-08-10 | 任勇 | Device and method for monitoring blood rheology on basis of renal arterial stent |
| CN105832311A (en) * | 2016-06-06 | 2016-08-10 | 任勇 | Coronary stent based hemorheological monitoring device and coronary stent based hemorheological monitoring method |
| CN105902259A (en) * | 2016-06-06 | 2016-08-31 | 任勇 | Blood flow speed monitoring device and method based on femoral artery stent |
| CN105832314A (en) * | 2016-06-06 | 2016-08-10 | 任勇 | Thoracic descending aorta stent based hemorheological monitoring device and thoracic descending aorta stent based hemorheological monitoring method |
| CN105832326A (en) * | 2016-06-06 | 2016-08-10 | 任勇 | Coronary stent based blood flow speed monitoring device and coronary stent based blood flow speed monitoring method |
| CN105852842A (en) * | 2016-06-06 | 2016-08-17 | 任勇 | Blood rheology monitoring device and method based on arteria femoralis stent |
| CN106725434A (en) * | 2016-12-30 | 2017-05-31 | 北京品驰医疗设备有限公司 | A kind of long-range monitoring and positioning system based on temperature feedback |
| WO2020092249A1 (en) | 2018-10-28 | 2020-05-07 | Cardiac Pacemakers, Inc. | Implantable medical device having two electrodes in the header |
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| EP0758542A1 (en) * | 1995-08-16 | 1997-02-19 | Ats Medical, Inc. | Heart valve prosthesis incorporating electronic monitoring and/or pacing circuitry |
| US6277078B1 (en) * | 1999-11-19 | 2001-08-21 | Remon Medical Technologies, Ltd. | System and method for monitoring a parameter associated with the performance of a heart |
| CN1377466A (en) * | 1999-07-29 | 2002-10-30 | 马科尼数据系统有限公司 | Piezo-electric tag |
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| EP0758542A1 (en) * | 1995-08-16 | 1997-02-19 | Ats Medical, Inc. | Heart valve prosthesis incorporating electronic monitoring and/or pacing circuitry |
| CN1377466A (en) * | 1999-07-29 | 2002-10-30 | 马科尼数据系统有限公司 | Piezo-electric tag |
| US6277078B1 (en) * | 1999-11-19 | 2001-08-21 | Remon Medical Technologies, Ltd. | System and method for monitoring a parameter associated with the performance of a heart |
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