WO2007139479A1 - Tubular catheter for invasive use and manufacturing method therefor - Google Patents

Tubular catheter for invasive use and manufacturing method therefor Download PDF

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Publication number
WO2007139479A1
WO2007139479A1 PCT/SE2007/000528 SE2007000528W WO2007139479A1 WO 2007139479 A1 WO2007139479 A1 WO 2007139479A1 SE 2007000528 W SE2007000528 W SE 2007000528W WO 2007139479 A1 WO2007139479 A1 WO 2007139479A1
Authority
WO
WIPO (PCT)
Prior art keywords
support member
invasive use
partly
use according
invasive
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/SE2007/000528
Other languages
English (en)
French (fr)
Inventor
Bengt KÄLLBÄCK
Anders Hult
Lars-Åke BRODIN
Håkan ELMQVIST
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CATHPRINT AB
Original Assignee
CATHPRINT AB
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by CATHPRINT AB filed Critical CATHPRINT AB
Priority to JP2009513096A priority Critical patent/JP5603071B2/ja
Priority to US12/301,536 priority patent/US20090143651A1/en
Priority to EP07748192A priority patent/EP2032201B1/en
Publication of WO2007139479A1 publication Critical patent/WO2007139479A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/02007Evaluating blood vessel condition, e.g. elasticity, compliance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021Measuring pressure in heart or blood vessels
    • A61B5/0215Measuring pressure in heart or blood vessels by means inserted into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053Measuring electrical impedance or conductance of a portion of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0538Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring 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
    • A61B5/14539Measuring 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 for measuring pH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • A61B5/279Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283Invasive
    • A61B5/287Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852Catheters
    • A61B5/6855Catheters with a distal curved tip
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C53/00Shaping by bending, folding, twisting, straightening or flattening; Apparatus therefor
    • B29C53/36Bending and joining, e.g. for making hollow articles
    • B29C53/38Bending and joining, e.g. for making hollow articles by bending sheets or strips at right angles to the longitudinal axis of the article being formed and joining the edges
    • B29C53/48Bending and joining, e.g. for making hollow articles by bending sheets or strips at right angles to the longitudinal axis of the article being formed and joining the edges for articles of indefinite length, i.e. bending a strip progressively
    • B29C53/52Bending and joining, e.g. for making hollow articles by bending sheets or strips at right angles to the longitudinal axis of the article being formed and joining the edges for articles of indefinite length, i.e. bending a strip progressively using external forming surfaces, e.g. sleeves
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C53/00Shaping by bending, folding, twisting, straightening or flattening; Apparatus therefor
    • B29C53/80Component parts, details or accessories; Auxiliary operations
    • B29C53/84Heating or cooling
    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05KPRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
    • H05K1/00Printed circuits
    • H05K1/02Details
    • H05K1/0274Optical details, e.g. printed circuits comprising integral optical means
    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05KPRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
    • H05K1/00Printed circuits
    • H05K1/18Printed circuits structurally associated with non-printed electric components
    • H05K1/189Printed circuits structurally associated with non-printed electric components characterised by the use of a flexible or folded printed circuit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/12Manufacturing methods specially adapted for producing sensors for in-vivo measurements
    • A61B2562/125Manufacturing methods specially adapted for producing sensors for in-vivo measurements characterised by the manufacture of electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/026Measuring blood flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring 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
    • A61B5/1468Measuring 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 chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473Measuring 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 chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056Transvascular endocardial electrode systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056Transvascular endocardial electrode systems
    • A61N2001/0585Coronary sinus electrodes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00Other particular articles
    • B29L2031/753Medical equipment; Accessories therefor
    • B29L2031/7542Catheters
    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05KPRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
    • H05K1/00Printed circuits
    • H05K1/02Details
    • H05K1/0272Adaptations for fluid transport, e.g. channels, holes
    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05KPRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
    • H05K1/00Printed circuits
    • H05K1/02Details
    • H05K1/0286Programmable, customizable or modifiable circuits
    • H05K1/0287Programmable, customizable or modifiable circuits having an universal lay-out, e.g. pad or land grid patterns or mesh patterns
    • H05K1/0289Programmable, customizable or modifiable circuits having an universal lay-out, e.g. pad or land grid patterns or mesh patterns having a matrix lay-out, i.e. having selectively interconnectable sets of X-conductors and Y-conductors in different planes
    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05KPRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
    • H05K1/00Printed circuits
    • H05K1/02Details
    • H05K1/11Printed elements for providing electric connections to or between printed circuits
    • H05K1/118Printed elements for providing electric connections to or between printed circuits specially for flexible printed circuits, e.g. using folded portions
    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05KPRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
    • H05K2201/00Indexing scheme relating to printed circuits covered by H05K1/00
    • H05K2201/05Flexible printed circuits [FPCs]
    • H05K2201/051Rolled
    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05KPRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
    • H05K2201/00Indexing scheme relating to printed circuits covered by H05K1/00
    • H05K2201/09Shape and layout
    • H05K2201/09009Substrate related
    • H05K2201/09072Hole or recess under component or special relationship between hole and component
    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05KPRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
    • H05K2203/00Indexing scheme relating to apparatus or processes for manufacturing printed circuits covered by H05K3/00
    • H05K2203/01Tools for processing; Objects used during processing
    • H05K2203/0104Tools for processing; Objects used during processing for patterning or coating
    • H05K2203/0126Dispenser, e.g. for solder paste, for supplying conductive paste for screen printing or for filling holes

Definitions

  • Tubular catheter for invasive use and manufacturing method therefor
  • the present invention relates to the field of devices for invasive use. Furthermore, it relates to a 5 method for manufacturing such a device and to the use of such a device.
  • EP-Al-I 714 610 shows a catheter wherein a flexible printed circuit board is mounted in a tube. An 15 electronic component is mounted on the flexible printed circuit board.
  • This catheter is relatively complex which makes manufacturing relatively expensive and which also can have a negative impact on reliability.
  • US-A1-5 199 433 shows an esophageal catheter comprising a structure with a flexible printed wire board
  • the structure is attached to a probe using adhesive.
  • This- construction is not suitable for invasive applications since it has a relatively large diameter. It can as well be cumbersome to use, since the structure has to be attached to the probe
  • US-A-5 902 330 there is shown a lead for a cardiac pacemaker wherein the stimulation electrode is glued to a supporting body.
  • Electrodes on the catheter are used for the impedance measurement, typically 10-12 electrodes.
  • the catheters known from the background art are too stiff and thick to be suitable for clinical use in
  • the catheters are long (in. the order of one meter) and thin (between 0,3 and 3mm)- and are composed of several electrical conductors and a guiding structure. These conductors are usually insulated wires often as thin as about 20-30 micrometer.
  • the guiding structure is often a
  • catheters for simultaneous measuring of pressure and volume in the ventricles of the heart are in some cases so thick and 5 stiff that they may cause arrhythmia and leakage through the valves.
  • a device for invasive use may
  • the support member 20 comprise a support member comprising a flexible material, wherein the support member comprises at least one layer of at least one electrically conductive line or pattern thereon.
  • the support member is at least partly formed into an elongated tube shape, and the inside of the support 25 member is at least partly sealed from the outside of the support member.
  • At least one electrically conductive line or pattern extends on the inside of the at least partly tube shaped support member, and the support member comprises at least one sensing, stimulating and/or 30 processing element.
  • the support member is at least partly filled with a flexible resilient material, such as an adhesive or a polymer. In another embodiment the support member is completely filled with a flexible resilient material, such as an adhesive or a polymer. 5
  • the inside of the support member is completely sealed from the outside of the support member.
  • the device for invasive use is adapted to be provisionally located in a body by surgical invasion while or for monitoring or influencing the function of an organ.
  • the device for invasive use is adapted to be provisionally located in a body by surgical invasion while or for monitoring or influencing the function of a heart.
  • the adjacent edges of the support member are at least partly joined by welding.
  • the adjacent edges of the support member are at least partly joined by an 25 adhesive.
  • the at least one sensing, stimulating and/or processing element comprises at least one electronic component or
  • microelectromechanical system provided on the inside of the at least partly tube shaped support member.
  • the support member has at least one opening therein and at least one of the at least one sensing, stimulating and/or processing element is aligned with said at least one opening.
  • the at least one electronic 5 component or microelectromechanical system is chosen among a pressure sensor, a voltage sensor, a pH sensor, a temperature sensor, a gas sensor, a component for detecting or quantifying a reagent (for example a protein), and a drug delivery device. 10
  • At least one electrode is placed on the outside of the at least partly tube shaped support member.
  • At least one electrode is placed on the inside of the at least partly tube shaped support member .
  • At least four electrodes 20 are provided on the device for invasive use, said at least four electrodes constituting a volume sensor.
  • At least one reinforcing or rigidifying element on the inside of the 25 support member.
  • the at least one reinforcing or rigidifying element extends beyond one or both ends of the support member.
  • the at least one reinforcing or rigidifying element comprises an optical fibre or waveguide.
  • the at least one electronic component or microelectromechanical system is placed adjacent a front end of the support member and in operational contact with the at least one electrically conductive line or pattern or said at least one optical 10 fibre .or waveguide.
  • a method for manufacturing a device for invasive use may comprise the steps of;
  • the tool or jig further comprises entrance means for keeping an adhesive material in, or bringing an adhesive
  • the tool or jig further comprises exit means for solidifying the adhesive material .
  • the method may further comprise the steps of:
  • the method for manufacturing further comprises the step of filling the support member with adhesive material as the support member is being fed through the hole in the tool or jig. 5
  • the method for manufacturing further comprises the step of at least partly joining the adjacent edges of the support member to each other by means of the adhesive material.
  • the adhesive 10 material is applied to at least one of. the adjacent edges of the support member.
  • the entry area is heated with the entrance means so as to heat the adhesive material. Further, the exit area of the hole is cooled with the exit means so as to solidify the adhesive material .
  • a method for manufacturing a device for invasive use may comprise the steps of:
  • the device for invasive use may be in any of the embodiments described above.
  • the device for invasive use may for example be used diagnostically or therapeutically.
  • said device is used for monitoring or influencing the function of a heart.
  • FIG. 1 is a schematic drawing sho.wing one example of the device 100 for invasive use
  • Fig. 2 is a detailed view of an electrode showing a via hole 121 and a via conductor 123,
  • Figs. 3a, 3b are drawings showing one embodiment of the 15 device 100 for invasive use
  • Fig. 4 is a cross section of one embodiment of the device
  • Figs. 5a, 5b are figures showing the back end of one embodiment of the device 100 for invasive use
  • 20 Figs, ⁇ a, 6b are detailed views showing different methods of mounting a pressure sensor 201
  • Fig. 7 is a drawing showing the front end of the device
  • Fig. 8 is a drawing showing the manufacturing principle of 25 the device 100 for invasive use
  • Fig. 9 is a drawing showing one embodiment of a manufacturing tool
  • Fig. 10 is a detailed view of the manufacturing tool
  • Fig. 11 is a view showing the support member, 30 Figs. 12, 13 show different aspects regarding manufacturing,
  • Figs. 14-16 are different detailed views of the device 100 for invasive use
  • Figs. 17a, 17b are drawings showing a prototype device of the device 100 for invasive use
  • Fig. 18 is a detailed view showing the mounting of a pressure sensor 303 on the prototype device 300
  • 5 Fig. 19 is an overview of a system 700 including the device 100 for invasive use
  • Figs. 20-22 show one example of the pressure sensor 201.
  • Figs. 23, 24 show examples of signals in the system 700.
  • Fig. 25 is a drawing showing the switches Switch_0 and 10 Switch 90.
  • the device 100 for invasive use the manufacturing thereof and its use will now be described in an exemplary way.
  • the device 100 for 5 invasive use described herein is generally a long (often about 0,05-2,5Om, advantageously about 0,1m - about 0,3m or about 0,3m - about 1,8m), thin (diameter about 0,l-3mm, advantageously about 0,3mm - about 2mm or about 0,5mm - about 1,5mm) and hollow probe that is inserted into organs
  • the device 100 for invasive use may be inserted into the body in various ways, e.g. through blood vessels or directly through body tissue.
  • pressure blood or tissue pressure
  • partial pressure of gases e.g. oxygen, temperature, flow velocity, pH and the presence, concentration, composition or other parameters regarding chemical substances.
  • sensors for example FET-based ' chemical sensors, may be used (Field Effect Transistor, FET) .
  • FET Field Effect Transistor
  • different organs such as for example the heart may be stimulated or affected.
  • Different ways of stimulating or affecting may be used such as electrical signals, heat, infusion of chemical substances and mapping with ultra sound.
  • the device may be used to stimulate or affect different organs such as for example the heart.
  • Different ways of stimulating or affecting may be used such as electrical signals, heat, infusion of chemical substances and mapping with ultra sound.
  • the 30 100 for invasive use may be longer or shorter.
  • the device 100 for invasive use is inserted through for example an artery or a vein it may be advantageous that the device 100 for invasive use is approximately 50-250 cm long.
  • the device 100 for invasive use is inserted
  • the device 100 for invasive use is about 120-240 cm long.
  • the device 100 for invasive use is introduced at the throat/cervix to reach the heart 5 it may be advantageous that the device 100 for invasive use is about 50-100 cm long.
  • the device 100 for invasive use When the device 100 for invasive use is inserted into an organ directly through tissue it may be advantageous that the device 100 for invasive use is about
  • the device 10-0 for invasive use is introduced into- the heart directly through the cardiac wall or through myocardium it may be advantageous that the device 100 for invasive use is about 30-60 cm long._The front end 107
  • the 15 may comprise at least one front end electrode 111 that is in contact with the substance surrounding the device 100 for invasive use.
  • the at least one front end electrode 111 may for example be used to measure voltages generated by nerve signals or by
  • the front end 107 may as well comprise at least one passive and/or active electronic component or microelectromechanical system 200 on the inside of the device 100 for invasive use.
  • Such an electronic component or microelectromechanical system 200 may as well comprise at least one passive and/or active electronic component or microelectromechanical system 200 on the inside of the device 100 for invasive use.
  • the 25 may e.g. comprise a pressure sensor 201, for example of the piezo electrical type, having contact with the surrounding body fluid through an access hole 115 in the device 100 for invasive use.
  • the pressure sensor 201 may comprise a piezo electrical crystal. Another example may
  • electrode 111 may also be used for stimulation with electrical voltage or current as in pacing applications or in the method described below, simultaneous measurement of pressure and volume of the heart's ventricles.
  • Multiple 5 electronic components and/or microelectromechanical systems 200 may be incorporated, it may for instance be advantageous to use several pressure sensors for diagnosis of stenosis in the coronary arteries to be able to measure the pressure on both sides of the stricture.
  • support member The basis for the device 100 for invasive use is a flexible strip or foil, hereafter called support member
  • the support member 101 is advantageously long, thin and narrow and advantageously comprises a suitable insulating material, e.g. polyimide or a cycloaliphatic polyolefine.
  • the material for the support member 101 is biologically-inert or bio-compatible.
  • the device 100 for invasive use may also be covered with a layer of
  • the measures of the support member 101 may in one advantageous embodiment be 100 cm long, 1.5 mm wide
  • the length, as well as the thickness and the width, may vary depending on the application.
  • the width may be in the interval of 0,5-5 mm, more advantageously 1-3 mm, and the thickness may be in the interval of 10-200 micrometer,
  • the via conductors 123 comprise electrically conductive material on the walls of the via holes 121.
  • the electrically conductive lines and patterns 111, 113, 117 may comprise a suitable metal, e.g. Copper or an electrically conductive polymer or another
  • the support member 101 with the electrically conductive lines and patterns 111, 113, 117 placed thereon or attached thereto may be called a flexible printed wire board (flexible PWB) and the electrically conductive lines and patterns 111, 113, 117
  • the support member 101 can for instance be attached to the support member 101 with standard flexible printed wire board manufacturing equipment.
  • the support member 101 comprises layers of electrically conductive lines and patterns 111, 113, 117 on both sides thereof (as in the embodiment described
  • first side 125 of the support member 101 (the side that will become the "inside" of the device 100 for invasive use) there are electrically conductive lines or patterns 117 and on a second side 127 (the side that will be electrically conductive lines or patterns 117 and on a second side 127 (the side that will be electrically conductive lines or patterns 117 and on a second side 127 (the side that will be electrically conductive lines or patterns 117 and on a second side 127 (the side that will
  • the lines or patterns 117 on the first side 125 of the support member 101 connect the front end electrodes 111 and/or the at least one electronic component and/or at least one microelectromechanical system 200 with the back
  • At least one electronic component and/or at least one microelectromechanical system 200 may be mounted, it/they may for example be flip-chip mounted or wire-bonded. Conducting adhesive, soldering or any
  • support member 101 is at least partly rolled up into a tube and simultaneously filled with adhesive or glue 601 that holds the support member 101 in a tube shape. Formation of the support member 101 at least partly into a tube is advantageously done by feeding the support member
  • system 200 that is used for measurement or stimulation may • be mounted over a hole or opening 115 in the support member 101 so as to have contact to the surrounding body tissue and/or fluids whereas signal processing components 200 are totally concealed. Parameters that may be measured
  • One such example could be several pressure sensors 201 in order to improve diagnosis of stenosis in the coronary arteries.
  • Fig. 5 shows how a optical conductor 129 may be
  • the optical conductor protrudes from the back end of the device 100 for invasive use.
  • Fig. 6a shows in detail the mounting of a pressure sensor 201 according to one suitable method.
  • bond pads 201a-201c on the pressure sensor 201 are respectively attached to the bond pads 118a-118c on the support member.
  • the bond pads may be attached to each other by for example soldering or conducting adhesive.
  • 16 may comprise a pressure sensor membrane 201e.
  • a support member membrane 131 mounted in the access hole 115 in the support member 101.
  • the pressure sensitive area 201d of 5 the pressure sensor 201 is placed in or over the access hole 115 in the support member 101.
  • Fig. ⁇ b shows in detail the mounting of a pressure sensor 201 according to a method that may be advantageous since it enables a strong or rigid fastening
  • the bond pads 201a-201c are placed on the upper side of the -pressure sensor 201. Said bond pads -201a-201c are electrically connected to the electrically conductive lines 207 on the underside of the pressure sensor 201 by
  • via conductors 205a-205c comprise electrically conductive material on the walls of the via holes 203a-c. That means that almost the entire area (except the pressure sensitive area 201d and
  • the via holes 203a-c) of the underside ' of the pressure sensor 201 can be used for mounting the pressure sensor 201 to the support member 101, e.g. by using an adhesive. This enables a strong fastening of the pressure sensor 201.
  • the bond pads 118a-118c on the support member 101 are
  • the bond pads 118a-118c on the support member 101 are connected to respective bond pad 201a-201c on the pressure sensor 201 e.g. by means of wire bonding (wires 209a- 209c), e.g. by using gold wires.
  • wire bonding wires 209a- 209c
  • the bonding wires connected the pressure sensor 201 including the bonding wires 209 may be covered by e.g. silicone to protect the bonding wires and further strengthen the mounting of the pressure sensor 201.
  • One advantage of using a support member 101 comprising electrically conductive lines or patterns 111, 113, 117 on both sides is that the back end electrodes 113 can be placed on the outside of the at least partly tube 5 shaped device 100 for invasive use. This is an advantage when using the back end electrodes 113 to connect the device 100 for invasive use to external electronic and data processing equipment. Placing the back end electrodes 113 on the outside enables an uncomplicated construction 10 of the contact for connecting the device 100 for invasive use to external electronic and data processing equipment.
  • the back end electrodes 113 may in this case also be contacted with means of a contact that is inserted
  • Another feature that may be advantageous is to provide the device 100 for invasive use with an effective shielding by adding a mesh of thin metal lines on the
  • the device 100 for invasive use is introduced into a canal, such as an artery or a vein, in the body it may be advantageous to introduce a catheter
  • the device 100 for invasive use has to be long enough (basically twice as long as needed from a clinical point of view) so that it can be held in position during the
  • the support member 101 has the full length
  • the back end electrodes 113 are placed close to the point where the device 100 for invasive use enters the body (or the point where the device 100 for invasive use protrudes from the body through the insertion hole) . In this way the part of the device 100 for invasive use
  • the back end electrodes 113 may comprise merely the support member 101 and it may be cut off or otherwise separated from the rest of the device 100 for invasive use after the catheter guide has been withdrawn.
  • the device 100 for invasive use only extends a short distance outside the body and the risk that the device 100 for invasive use should be hindering or damaged is reduced substantially.
  • the device 100 for invasive use described herein has been verified by the design and manufacture of a prototype device 300 for the simultaneous measurement of 5 pressure and volume of the heart's left ventricle.
  • the prototype device 300 is shown in figs. 17 and 18.
  • the prototype device 300 is described in detail below.
  • a prototype support member 301 made of a flexible material was provided with electrically conductive lines
  • the dimensions of the prototype support member 301 were: length 35 cm, width 2,1 mm and
  • soldering pad 318a-318c in electrical contact with respective line, was placed.
  • the other 4 lines were terminated at via holes 321 connecting the lines to front end electrodes 311a-311d on the second side
  • the via holes 321 connect the lines to the outside electrodes 311, 313 by means of electrically conductive material (via conductors) 323 on the walls of the via holes 321.
  • the front end electrodes 311a-311d were
  • the pressure sensor chip 30 placed with two electrodes on each side of the pressure sensor chip 303.
  • 4 front end electrodes 311 were used but depending on the measurement method or application fewer or more electrodes may be used.
  • the arrangement of the electrodes is adapted to the
  • the metal copper was used, approximately 20 ⁇ m thick.
  • the conductor lines 317 were covered 5 with a layer of a suitable material (for example tin or silver+gold) to enable soldering of the pressure sensor chip 303.
  • the electrodes 111, 113 were covered with a layer of a material suitable (for example gold) to make the device
  • the conductor lines 317 were 100 ⁇ m wide with distances of 100 ⁇ m between the lines.
  • the pressure sensitive area 303d of the pressure sensor 303 may comprise a pressure sensor membrane 303e (not shown) Solder paste was applied to the bonding pads
  • the prototype support member 301 was fed through a funnel-like opening 611 and a through-hole 609 in a tool or jig 600 (figs. 8- 10) where the diameter of the through-hole 609 was 0,7 mm.
  • the funnel-like opening 611 was heated in the upper part to 140° C where also a suitable adhesive was provided, in this case PolyCaproLacton (PCL) was used. This adhesive melted and filled the interior of the support member while
  • the pressure sensor chip 303 was of a kind 5 adapted to be contained in the small space inside the tube shaped prototype support member 301.
  • the length of the prototype device 300 needs to be increased to make it suitable for some clinical applications but this can be accomplished with existing techniques for the production of flexible printed wire boards in a way easily derivable for the person skilled in
  • the reinforcing or rigidifying element 103 may be provided along the entire length of the device 100 for invasive use or merely along a portion of the
  • the reinforcing or rigidifying element 103 may for example comprise a wire or string made of for example metal or polymer, and/or the reinforcing or rigidifying element 103 may comprise the solidified or crystallized
  • the ' reinforcing or rigidifying element 103 may also comprise a lumen. If the reinforcing or rigidifying element 103 comprises a lumen 5 (or at least one lumen) it may be used for taking samples from inside the body or for distributing substances, like medicine, to the body.
  • 10 invasive use can be adapted to different applications, for example the application where the device 100 for invasive use is inserted to the desired location directly through tissue.
  • the device 100 for invasive use may for example be inserted through myocardium and subsequently withdrawn
  • the reinforcing or rigidifying element 103 may be double as long as the support member 101 and extend beyond the back end 109 of the device 100 for invasive use
  • the reinforcing or rigidifying element 103 may also extend -(e.g. about 5-30mm, advantageously about 7-13 mm)
  • the reinforcing or rigidifying element 103 extends beyond the front end 107 of the support member 101 it is advantageous that the extending part of the reinforcing or
  • rigidifying element 103 is bent, for example by using heat, and biocompatible.
  • the length, diameter, rigidity, curvature and other characteristics of the part of the reinforcing or rigidifying element 103 extending beyond 5 the front end 107 of the support member 101 are adapted to. the application or use in guestion.
  • the reinforcing or rigidifying element 103 may in this way enable an effective and precise guidance of the device 100 for invasive use e.g. in a network of blood vessels.
  • the device 100.for invasive use is used for monitoring parameters in the ventricle/s of the heart it may be advantageous to provide the device 100 for invasive use with a reinforcing or rigidifying element 103 since the device 100 for invasive use is bent very frequently as
  • the device 100 for invasive use may be damaged by the frequent bending. This of course also applies to other applications where the device 100 for invasive use is subjected to frequent
  • the device 100 for invasive use may also be advantageous to provide the device 100 for invasive use with a soft tip 105 integrated at the front end of the device 100 for invasive use (fig. 7) .
  • the tip 105 is advantageously formed when cutting the flexible
  • the tip 105 constitutes an integrated part of the device 100 for invasive use.
  • the tip 105 is advantageous when the device 100 for invasive use is inserted into the body, for example when the device
  • the soft tip 105 ensures that the surrounding tissue, muscle or artery or vein is not damaged or penetrated.
  • 25 support member 101 is around 50 micrometer thick and the tip 105 is approximately 0.7mm wide, ca 30mm long, and ' includes a fine graded transition to the approximately 2mm wide part of the support member 101. These measures make 5 the tip 105 soft and prevents that the heart is injured or disturbed (for example arrhythmia) when the device 100 for invasive use e.g. is inserted, withdrawn or in its end position.
  • the tip 105 ca-n not fall off.
  • the devices for invasive use (often ' called catheters)' ⁇ known from the background art separate tips of for example platinum have been used and in some cases they have fallen
  • a medical device such as a feeding probe.
  • nerve signals from the diaphragm may be measured with the at least one front end electrode 111 of the device 100 for invasive
  • the attachment may be accomplished by means of for example an adhesive or some other attachment means.
  • an elongated support member 101 is at least partly brought into a tube shape and the inside of the tube shaped support member 101 is at least partly sealed 5 from the outside.
  • The. support member 101 has at least one electrical conductor on one or both sides of the support member 101 and may advantageously be equipped with at least one electronic component and/or at least one microelectromechanical system 200. It may be an advantage
  • the at least one electronic component and/or at least one microelectromechanical system 200 is mounted on the support member 101 before the support member 101 is, at least partly, formed into a tube
  • the device 100 for invasive use is equipped with a reinforcing or rigidifying element 103 on the inside of the at least partly tube shaped support
  • the support member 101 is provided with a tip 105 at at least one of the ends of the support member.
  • the tip 105 is narrower than the rest of the support member and may have a length of approximately
  • a jig or tool 600 made out of a block of material like metal or plastic is used.
  • the metal used may for example be steel, brass, copper or any other alloy.
  • 27 plastic may for example be polymethacrylate, known as PlexiglassTM.
  • the jig or tool 600 is provided with a small hole 609 having a funnel-like opening 611.
  • the hole 609 and the 5 funnel-like opening 611 are adapted not to damage the support member 101 or the conductive patterns 111, 113 or other elements provided on the second side 127 of the support member 101.
  • a lining be provided in the hole 609 and/or funnel-like opening 611.
  • The. tip 105 of the support member 101 is. threaded trough the f-unnel-like opening 611 and the small hole 609.
  • the opening 611 is filled with an adhesive or glue 601, it may be advantageous to use PolyCaproLacton (PCL) which has a good adhesion to polyimide.
  • PCL PolyCaproLacton
  • an adhesive 601 is selected that has a good adhesion to the material of the support member 101.
  • the adhesion between the adhesive 601 and the support member 101 needs to be good to maintain the support member 101 in a tube shape.
  • the adhesive 601 is ' melted and fills the support member 101.
  • the support member 101 is pulled through the lower part of the hole, it is cooled and the PCL crystallizes (it becomes solid) and forms a reinforcing or rigidifying element 103.
  • 25 element 103 may comprise the solidified adhesive material, a separate reinforcing or rigidifying element or a combination of the solidified adhesive material and the separate reinforcing or rigidifying element.
  • the separate reinforcing or rigidifying element e.g. a wire or the
  • the adhesive material will fill the via holes 121 completely and will substantially be in line with the outside surface of the support member 101. If the device
  • the adhesive material used is biocompatible .
  • the jig or tool 600 comprises three 10 layers,, an upper heating layer 603, a middle, insulation layer 605 and a bottom cooling layer 607.
  • a hole 609 with a diameter of 0.7mm passes through the three layers in the jig or tool 600.
  • the upper layer 603 is heated to a temperature between +75 and +200 °C and the lower layer 607
  • the middle layer 605 is used as insulation layer.
  • the support member 101 is 2mm wide and at least one of the ends of the support member 101 is provided with a 0.7mm wide tip 105.
  • One of the tips is, in an advantageous embodiment, ca 30 mm long, and includes a fine graded transition to the 2mm wide part of the support
  • That tip 105 is pulled down into the funnel- like opening 611, which has a maximum diameter of 7.9 mm and connects to the hole 609 having a diameter of 0.7 mm. It may be advantageous to use a steel wire loop that is threaded with the tip 105 of the support member 101 to
  • the support member 101 substantially corresponds to the diameter of the hole 609 times ⁇ . In this way the support member 101 is formed
  • the funnel-like opening 611 is shaped as shown in 5 figs. 9 and 10. One side of the funnel-like opening 611 is substantially vertically leading down to the hole 609 and the inclination-angle of the funnel-like opening 611 gets gradually smaller as one moves from the substantially vertical side towards the opposite side of the funnel-like
  • the hole 609 may be lined, e.g. with a lining tube 613 as shown in fig. 10.
  • the lining of the hole 609 is advantageous since it is a convenient way to ensure that the hole 609 has a smooth
  • the tube 613 extends a certain distance (in fig. 10 2,2mm) passed the joint between the layers 603 and 605 to ensure that no adhesive or glue 601 enters the joint between the layers 603 and 605.
  • the lining tube 613 has an
  • the front part of the support member 101 is the front part of the support member 101 .
  • the clip is coupled to a pulling mechanism by a thread, the pulling mechanism may for example be driven by a motor such as a DC-motor.
  • the clip 31 means are provided to prevent the clip from turning.
  • the clip may be held in place with a stiff board, which the clip leans towards as it moves downwards.
  • the support member 101 is caught by hand and released from the clip. It may in some cases be desirable not to form the last part of the support member 101 into a tube shape. In this case the supply of adhesive 601 is simply stopped when the end of the support member
  • the joint between the edges of the support member 101 forms a spiral so that the edges of the support member 101 overlap one another to provide a more rigid device 100 for invasive use. It may also be possible to make the spiral shape so that there is no overlap of the side edges of the
  • glue or adhesive 601 may be applied to the inside surface close to the side edges to form the support member 101 into a tube shape that is more rigid than when the joint between the side edges is straight .
  • An alternative to filling the at least partly tube shaped support member 101 with glue or adhesive 601 may be to feed a meltable string of solid glue or adhesive or another suitable polymer/additive with appropriate diameter through the funnel-shaped opening 611 and hole
  • a layer or primer may be applied to the inside of the support member 101 to enhance the adhesion between the meltable string and the inner surface of the support member 101 during the roll-up process.
  • the layer may also protect
  • layers are Polycaprolacton lacquer and Parylene .
  • Parylene A non-limiting 5 example of Parylene is the product Parylene HTTM (Specialty. Coating Systems, Indianapolis, USA) .
  • the meltable string may melt (partly, only on the surface, or fully) and fill the support member 101 in the upper end and be solidified in the lower end as described above. Any other method of
  • a tube of the support member 101 may also be used, even though the method described here may be advantageous .
  • the jig or tool 600 may be provided with welding equipment that welds
  • the support member 101 may also be provided with a separate reinforcing or rigidifying element 103 as the support member 101 is drawn through the jig or tool
  • the reinforcing or rigidifying element 103 may advantageously be provided on the inside of the at least partly tube shaped support member 101.
  • the reinforcing or rigidifying element 103 may be attached to the clip together with the tip 105.
  • reinforcing or rigidifying element 103 may comprise at least one optical fibre or waveguide 129 for providing a communication possibility between the back end electrodes 113 and the at least one electronic component and/or at least one microelectromechanical system 200 and/or at
  • the at least one optical fibre or ' waveguide may be used in addition to, or instead of, the electrically conductive lines or patterns 117. 5
  • the front end of the support member 101 may be sealed with an adhesive, by means of the reinforcing or rigidifying
  • the support members 101 may be manufactured simultaneously in great numbers. In one example, support members 101 are
  • the support members 101 are preferably separated from one another by a suitable perforation or other suitable technologies .
  • the perforation may be added before the perforated sheet or
  • the at least one electronic component and/or at least one 5 microelectromechanical system 200 is attached by standard pick-and-place equipment using conducing glue, soldering or some other method.
  • the sheet or panel 133 is fed into a tool or jig 600 with several parallel holes 609 with funnels-shaped openings 611. The feeding mechanism is 10 omitted in the. figure. This would constitute a fully continuous process.
  • Devices 100 for invasive use can be cut off in batches after passage of the tool or jig 600.
  • the device 100 for invasive use may also be manufactured relatively inexpensive which facilitates the use of the device 100 for invasive use as a single use article .
  • the manufacturing process brings advantages for example in terms of automation.
  • the manufacturing process is also easy to implement in a bigger scale since several devices can be manufactured in parallel. 5
  • the support member 101 may also be advantageous to provide the support member 101 with a sharp point for facilitating the insertion of the device 100 for invasive use through tissue to an organ.
  • the sharp point may be in the form of 10 a needle.
  • the device 100 for invasive use is adapted to extend from an organ at least to a point of surgical incision. 15
  • the device 100 for invasive use is adapted to extend from the heart at least to the groin.
  • the device 100 for invasive use may be used as part of a system for monitoring, examining or treating a patient.
  • a system 700 for monitoring the heart will be described (see in particular
  • the system 700 enables the function of the left ventricle of the heart to be monitored in real time, during for example invasive heart examination, heart operation or post operative treatment.
  • the system 700 comprises the device 100 for invasive use, an accompanying
  • a device 100 for invasive use which is thin, supple and comprises a soft tip 105, is introduced or inserted through an artery in the groin so that the front end 107 of the device 100 for invasive use is placed
  • a catheter guide is advantageously used when the device 100 for invasive use is introduced.
  • the device 100 for invasive use 5 may be inserted into the femoral aorta and pushed through the aorta and into the left ventricle of the heart. With the device 100 for invasive use volume and pressure in the left ventricle of the heart can be measured and a Pressure- Volume diagram can be displayed. A physician can
  • the device 100 for invasive use is in this case implemented as a multi-functional device combining means for conductance/impedance measurement (front end
  • the volume measurement functions as an impedance measurement.
  • four front end electrodes llla-llld are placed, two of them excitation electrodes Ilia, llld and between these, two
  • the device 100 ' for invasive use is placed so that the fore part is substantially aligned with the longitudinal axis of the left ventricle.
  • the excitation electrodes Ilia, llld are placed to be on a level with the apex of the heart ⁇ apex
  • the two excitation electrodes Ilia, llld are fed with a voltage Uexcitation so that an alternating current I eX citation with the frequency 20 kHz and the intensity 100 micro-ampere flows between the two excitation electrodes, this is in
  • alternating current is used to avoid interference with cardiac electro-physiology.
  • An electromagnetical field will be generated in the left ventricle, which creates a voltage U mea sured that may be measured with the two
  • the measured voltage Umeasured will be proportional to the impedance Z mea s.eiec. between the two measurement electrodes 111b, 111c according to the equation:
  • the impedance Z mea s.eiec. will in turn be dependent on the volume in the ventricle.
  • 25 impedance is the impedance present between the two measurement electrodes.
  • the demodulation works as follows.
  • the signal U mea sured is divided into two signals where one is phase shifted 180°.
  • Both signals U mea sured and U meaS ured (+180°) are then switched in two switches, switch_0 and switch 90.
  • Each of the two switches are controlled by a control pulse, where one control pulse (CP_0) has the same phase as the signal U exC it a tio n and the other (CP_90) is phase shifted +90° in relation to U exc itation- Switch_0 is controlled by CP_0 and switch_90 is controlled by CP_90.
  • CP_0 one control pulse
  • CP_90 phase shifted +90° in relation to U exc itation- Switch_0
  • switch_90 is controlled by CP_90.
  • the input signals for switch_0 are 20 shown.
  • Reference sign 23al denotes the control pulse CP_0 to switch_0
  • 23a2 denotes O measnred
  • 23a3 denotes U meaSured (+180) .
  • the measured signal U meaS u r ed has the same phase as the control pulse CP_0 which corresponds to a real valued impedance .
  • 25 In fig. 23b the input signals for switch_90 are shown.
  • Reference sign 23bl denotes the control pulse CP_90 to switch_90
  • 23b2 denotes U meaS uredf
  • 23b3 denotes U mea su r ed (+180) .
  • the system works well as an impedance meter and measures the impedance with good accuracy approximately 5 +0.5 ohm.
  • the measurement of the volume is however an approximation and is dependent on that the system is adjusted for a specific positioning of the device 100 for invasive use.
  • the fore part of the device 100 for invasive use will be placed along the vertical axis of
  • the accuracy of the volume measurement will be approximately ⁇ 3 ml, but be better for lower volumes (under 120 ml) .
  • the impedance of the blood is much lower than that of the surrounding tissues which is vital for the measurement to work.
  • the surrounding tissues which is vital for the measurement to work.
  • a pressure sensor 201 is used for the pressure measurement.
  • the pressure sensor 201 is mounted on the
  • the pressure sensor 201 is a MEMS-chip (Micro Electro Mechanical Systems) that in this embodiment comprises two resistors, R p and Rt- When the pressure
  • the pressure sensor 201 contains a half bridge that is connected to two other resistors Ri and R 2 to form a complete Wheatstone bridge.
  • the resistors Ri are connected to two other resistors Ri and R 2 to form a complete Wheatstone bridge.
  • the sensitivity of the pressure measurement depends on the type of pressure sensor 201 used. For a number of common pressure sensors the sensitivity may vary from 28.6 ⁇ V/V/kPa to 102,1 ⁇ V/V/kPa. Four pressure sensors based on the same principle have been used for
  • the sensitivity of the pressure sensors is dependent on their geometry. The larger the sensor is, the larger is its pressure sensitive membrane and therefore its sensitivity.
  • each device 100 for invasive use is saved in a memory placed in a contact (not shown) that is used to connect the device 100 for invasive use to the equipment for signal processing and displaying.
  • Each device 100 for invasive use is provided with a dedicated
  • the calibration data will include the sensitivity of the pressure sensor 201 and its contribution to the imbalance in the Wheatstone bridge. It 5 is advantageous to calibrate the system to the atmospheric pressure prevailing when the device 100 for invasive use is used. When calibrated the accuracy for the pressure measurement will be good, approximately +/- 133 Pa. An accuracy in this range is advantageous for the application
  • R p is the pressure sensitive resistor.
  • R t is a reference resistor with the same ⁇ temperature dependence as R p and hence has the function of compensating for temperature.
  • the pressure sensor 201 is
  • 20 sensitive area 201d (which may include a pressure sensor membrane 20Ie) on the pressure sensor 201.
  • Support member e.g. foil
  • Reinforcing or rigidifying element (wire, solidified glue, 5 optical fibre or the like) - 103

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US12/301,536 US20090143651A1 (en) 2006-06-01 2007-05-31 Device for Invasive Use
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