WO2021188891A1 - Signal conducting device for concurrent power and data transfer to and from un-wired sensors attached to a medical device - Google Patents

Signal conducting device for concurrent power and data transfer to and from un-wired sensors attached to a medical device Download PDF

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Publication number
WO2021188891A1
WO2021188891A1 PCT/US2021/023148 US2021023148W WO2021188891A1 WO 2021188891 A1 WO2021188891 A1 WO 2021188891A1 US 2021023148 W US2021023148 W US 2021023148W WO 2021188891 A1 WO2021188891 A1 WO 2021188891A1
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WO
WIPO (PCT)
Prior art keywords
power
channels
sensors
conductive member
signal
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Ceased
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PCT/US2021/023148
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English (en)
French (fr)
Inventor
Richard J. Linder
Edwin Meade MAYNARD
Scott Kenneth Marland
Cory Rex ESTES
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Xenter Inc
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Xenter Inc
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Publication date
Application filed by Xenter Inc filed Critical Xenter Inc
Priority to AU2021240036A priority Critical patent/AU2021240036A1/en
Priority to CN202180036656.7A priority patent/CN115697471A/zh
Priority to KR1020227036169A priority patent/KR102868148B1/ko
Priority to JP2022556648A priority patent/JP7720318B2/ja
Priority to EP21770508.6A priority patent/EP4106862A4/en
Publication of WO2021188891A1 publication Critical patent/WO2021188891A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements 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
    • A61B5/6847—Arrangements 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
    • A61B5/6851—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00097—Sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
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    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • A—HUMAN NECESSITIES
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    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • A61B5/02158—Measuring pressure in heart or blood vessels by means inserted into the body provided with two or more sensor elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/07—Endoradiosondes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements 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
    • A61B5/6847—Arrangements 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
    • A61B5/6852—Catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/12—Arrangements for detecting or locating foreign bodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • H—ELECTRICITY
    • H02—GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
    • H02J—ELECTRIC POWER NETWORKS; CIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
    • H02J50/00—Circuit arrangements or systems for wireless supply or distribution of electric power
    • H02J50/001—Energy harvesting or scavenging
    • H—ELECTRICITY
    • H02—GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
    • H02J—ELECTRIC POWER NETWORKS; CIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
    • H02J50/00—Circuit arrangements or systems for wireless supply or distribution of electric power
    • H02J50/05—Circuit arrangements or systems for wireless supply or distribution of electric power using capacitive coupling
    • H—ELECTRICITY
    • H02—GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
    • H02J—ELECTRIC POWER NETWORKS; CIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
    • H02J50/00—Circuit arrangements or systems for wireless supply or distribution of electric power
    • H02J50/40—Circuit arrangements or systems for wireless supply or distribution of electric power using two or more transmitting or receiving devices
    • H02J50/402—Circuit arrangements or systems for wireless supply or distribution of electric power using two or more transmitting or receiving devices the two or more transmitting or the two or more receiving devices being integrated in the same unit, e.g. power mats with several coils or antennas with several sub-antennas
    • H—ELECTRICITY
    • H02—GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
    • H02J—ELECTRIC POWER NETWORKS; CIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
    • H02J50/00—Circuit arrangements or systems for wireless supply or distribution of electric power
    • H02J50/90—Circuit arrangements or systems for wireless supply or distribution of electric power involving detection or optimisation of position, e.g. alignment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A61B1/05—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances characterised by the image sensor, e.g. camera, being in the distal end portion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2503/00—Evaluating a particular growth phase or type of persons or animals
    • A61B2503/40—Animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0204—Operational features of power management
    • A61B2560/0214—Operational features of power management of power generation or supply
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0204—Operational features of power management
    • A61B2560/0214—Operational features of power management of power generation or supply
    • A61B2560/0219—Operational features of power management of power generation or supply of externally powered implanted units
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0247—Pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/06—Arrangements of multiple sensors of different types
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/22—Arrangements of medical sensors with cables or leads; Connectors or couplings specifically adapted for medical sensors
    • A61B2562/221—Arrangements of sensors with cables or leads, e.g. cable harnesses
    • A61B2562/222—Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0183—Rapid exchange or monorail catheters
    • H—ELECTRICITY
    • H02—GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
    • H02J—ELECTRIC POWER NETWORKS; CIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
    • H02J2105/00—Networks for supplying or distributing electric power characterised by their spatial reach or by the load
    • H02J2105/40—Networks for supplying or distributing electric power characterised by their spatial reach or by the load characterised by the loads connecting to the networks or being supplied by the networks
    • H02J2105/46—Medical devices, medical implants or life supporting devices

Definitions

  • the present invention relates generally to medical devices, including intraluminal devices such as guidewires and catheters that include various sensors for simultaneous and/or continuous measuring of one or more physiological parameters.
  • Guidewire devices are often used to lead or guide catheters or other interventional devices to a targeted anatomical location within a patient’s body.
  • guidewires are passed into and through a patient’s vasculature in order to reach the target location, which may be at or near the patient’s heart or brain, for example.
  • Radiographic imaging is typically utilized to assist in navigating a guidewire to the targeted location.
  • Guidewires are available with various outer diameter sizes. Widely utilized sizes include 0.010, 0.014, 0.016, 0.018, 0.024, and 0.035 inches in diameter, for example, though they may also be smaller or larger in diameter.
  • a guidewire is placed within the body during the interventional procedure where it can be used to guide multiple catheters or other interventional devices to the targeted anatomical location.
  • a catheter can be used to aspirate clots or other occlusions, or to deliver drugs, stents, embolic devices, radiopaque dyes, or other devices or substances for treating the patient.
  • IVUS intravascular ultrasound
  • a catheter with an ultrasound imaging sensor attached to the distal portion.
  • Ultrasound is utilized to image within targeted vasculature (typically the coronary arteries).
  • Another issue common to the field is proper localization and positioning of the distal portion of the device at the target location. If the device tip is improperly positioned during insertion, or if the tip migrates away from the desired position after insertion, various risks can arise. For catheter implementations, for example, improper positioning can lead to fluid infusions that can cause pain or injury to the patient, increased thrombosis rates, delays in therapy, device breakage or malfunction, delays due to device replacement, and additional costs associated with the device replacement and the additional time required by the attending physician and the medical center. [0009] Further, conventional approaches to internal imaging and catheter localization require the injection of dye and/or the use of X-rays. Each of these can be harmful to the subject. In addition, such imaging radiation can be harmful to the physicians and staff exposed to the radiation.
  • Disclosed embodiments include a method for concurrent power and data transfer in a medical device.
  • the method comprises providing an elongated conductive member, at least a portion thereof configured for insertion within an intraluminal space.
  • the elongated conductive member comprises a proximal portion and a distal portion configured to conduct electrical signals.
  • the method also includes allocating a signal space into a plurality of unique contiguous segments. Additionally, the method includes uniquely allocating each of the plurality of unique contiguous segments to one of (i) one or more power channels or (ii) one or more signal channels.
  • the method includes sending the electrical signals, via the elongated conductive member, to one or more sensors that are in electrical connection with the elongated conductive member.
  • the method includes harvesting energy from the electrical signals within at least one of the one or more power channels. Further still, the method includes isolating transmitted data signals from at least one of the one or more signal channels, the data signals transmitted via the elongated conductive member and the data signals generated by the one or more sensors.
  • Additional disclosed embodiments include a medical device system for concurrent power and data transfer.
  • the medical device system comprises an elongated conductive member, at least a portion thereof configured for insertion within an intraluminal space.
  • the elongated conductive member comprises a proximal portion and a distal portion.
  • the medical device system also comprises one or more sensors that are in electrical connection with the elongated conductive member.
  • the medical device system comprises one or more electrical components that are physically configured such that, when activated, the one or more electrical components cause the medical device system to perform various acts. For example, the medical device system allocates a signal space into a plurality of unique contiguous segments.
  • the medical device system uniquely allocates each of the plurality of unique contiguous segments to one of (i) one or more power channels or (ii) one or more signal channels.
  • the medical device system also sends the electrical signals, via the elongated conductive member, to one or more sensors that are in electrical connection with the elongated conductive member. Further, the medical device system harvests energy from the electrical signals within at least one of the one or more power channels. Further still, the medical device system isolates transmitted data signals within at least one of the one or more signal channels, via the elongated conductive member, the data signals generated by the one or more sensors.
  • the method includes sending the electrical signals, via the elongated conductive member, to one or more sensors that are in electrical connection with the elongated conductive member. Further, the method includes harvesting energy from the electrical signals within at least one of the one or more power channels. Further still, the method includes isolating transmitted data signals from at least one of the one or more signal channels, the data signals transmitted via the elongated conductive member and the data signals generated by the one or more sensors.
  • Figure 1 illustrates a schematic overview of a guidewire system configured to provide one or more of the features described herein;
  • Figure 2 illustrates a catheter system configured to provide one or more of the features described herein, showing components of a power and data coupling device and showing that the coupling device may be communicatively coupled to an external device;
  • Figure 3 A illustrates a more detailed view of the guidewire system of Figure 1 , showing components of a power and data coupling device and showing that the coupling device may be communicatively coupled to an external device;
  • Figure 3B is an expanded view of a distal section of the guidewire to better illustrate exemplary sensor arrangement on the guidewire;
  • Figure 3C is a schematic view of a distal section of the guidewire to illustrate additional distal components and features of the device;
  • Figures 4A-4D illustrate an exemplary use of the guidewire system to effectively guide positioning and deployment of a stent at a targeted stenosis;
  • Figure 5 illustrates an extension wire being added to the wire
  • Figure 6A illustrates an electrical schematic diagram of a medical device
  • Figure 6B illustrates another electrical schematic diagram of the medical device
  • Figure 7 illustrates channels configured for utilization by the medical device
  • Figures 8A-8C depict various signal schematic diagrams of the medical device.
  • Figure 9 illustrates a flow chart of a method for concurrent power and data transfer in a medical device.
  • FIG. 1 illustrates a schematic overview of a guidewire system 100 that may incorporate one or more of the features described herein.
  • the guidewire system 100 includes a wire 102 that is routable through a proximal device 104.
  • the guidewire system 100 may sometimes be alternatively referred to herein as the “guidewire device”.
  • the wire 102 may also be referred to as a type of elongated conductive member.
  • the elongated conductive member comprises any conductive component that is longer than it is wide.
  • the elongated conductive member includes the wire 102.
  • the elongated conductive member may also be referred to as the wire 102; however, one will appreciate the wire 102 is a subset of possible elongated conductive members.
  • the elongated conductive member may also comprise a catheter.
  • the “wire” of the guidewire system 100 refers to the solid wire element that forms the backbone of the guidewire system 100.
  • the term “wire”, when used in the context of the guidewire system 100, is therefore intended to refer to a structure that has sufficient characteristics of torqueability, pushability, and stiffhess/flexibility to be navigable within a body (e.g., capable of being positioned within an intraluminal space such as the vasculature).
  • Such a “wire” element is sometimes referred to in the art as a “core”, “core wire”, or the like.
  • a “wire” suitable for use as part of the guidewire system 100 can have an average outside diameter of at least about 0.003 inches, or about 0.005 inches, or about 0.008 inches, or about 0.010 inches.
  • a “wire” suitable for use as part of the guidewire system 100 can have yield strength above 10 ksi, or more preferably above 30 ksi, or more preferably above 50 ksi, or more preferably above 100 ksi, or more preferably above 150 ksi, or more preferably above 200 ksi, or more preferably above 250 ksi, such as 300 ksi.
  • the “wire” suitable for use as part of the gui dewire system 100 can have a shear modulus above 6.7 msi, or more preferably above 8 msi, or more preferably above 10 msi, such as about 12 msi.
  • the “wire” suitable for use as part of the guidewire system 100 can have a modulus of elasticity of above 16 msi, or more preferably above 20 msi, or more preferably above 25 msi, such as about 30 msi.
  • the wire 102 of the guidewire system 100 is configured for insertion into the body of a subject.
  • the subject is typically a human, but in other implementations may be a non-human mammal or even non-mammalian animal. Any suitable route of administration may be utilized, depending on particular preferences and/or application needs. Common routes include femoral, radial, and jugular, but the guidewire system 100 may utilized other access routes as needed.
  • the proximal device 104 is shown here as a hemostatic valve, though in other embodiments the proximal device 104 may include additional or alternative forms.
  • the proximal device 104 may also be referred to herein as the “power and data coupling device 104” or simply the “coupling device 104”.
  • the wire 102 has a proximal portion 106 and a distal portion 108.
  • the length of the wire 102 may vary according to particular application needs and targeted anatomical area.
  • the wire 102 may have an overall length from proximal portion 106 to distal portion 108 of about 50 cm to about 350 cm, more commonly about 200 cm, depending on particular application needs and/or particular anatomical targets.
  • the wire 102 may have a size such that the outer diameter (e.g., after application of other outer members) is about 0.008inches to about 0.040 inches, though larger or smaller sizes may also be utilized depending on particular application needs.
  • particular embodiments may have outer diameter sizes corresponding to standard guidewire sizes such as 0.010 inches, 0.014 inches, 0.016 inches, 0.018 inches, 0.024 inches, 0.035 inches, 0.038 inches, or other such sizes common to guidewire devices.
  • the wire 102 may be formed from stainless steel or other metal or alloy having appropriate mechanical properties. Additionally or alternatively, the wire 102 may be formed from an electrically conductive material of appropriate mechanical properties.
  • the coupling device 104 may also include or be associated with a transmitter to enable wireless communication between the guidewire system 100 and an external device 110 (or multiple such external devices).
  • the guidewire system 100 and external device 110 may be connected via a wired connection.
  • the external device 110 may be a hand-held device, such as a mobile phone, tablet, or lap-top computer. Although exemplary embodiments are described herein as using hand-held or mobile devices as the external devices 110, it will be understood that this is not necessary, and other embodiments may include other “non-mobile” devices such as a desktop computer, monitor, projector, or the like.
  • the external device 110 includes a mobile/hand-held device and additionally includes a desktop device or other non-mobile device.
  • a mobile device may be configured to receive transmitted data from the transmitter and function as a bridge by further sending the data to the non-mobile computer system.
  • This may be useful in a situation where the physician would like the option of viewing data on a mobile device but may need to have the data additionally or alternatively passed or mirrored on a larger monitor such as when both hands are preoccupied (e.g., while handling the guidewire system 100).
  • the external device 110 of the guidewire system 100 may assist the physician in determining a position of the distal tip of the wire 102 within a vessel or other targeted anatomy of the human body. In this manner, the physician can appropriately position the wire 102 while also obtaining data of various parameters at the targeted anatomy so that the physician can better understand the relevant environment and make appropriate decisions while treating a patient.
  • the wireless system(s) may include, for example, a personal area network (PAN) (e.g., ultra-high frequency radio wave communication such as Bluetooth®, ZigBee®, BLE, NFC), a local area network (LAN) (e.g., WIFI), or a wide area network (WAN) (e.g., cellular network such as 3G, LTE, 5G).
  • PAN personal area network
  • LAN local area network
  • WIFI wireless wide area network
  • Wireless data transmission may additionally or alternatively include the use of light signals (infrared, visible radio, with or without the use of fiber optic lines), such as radiofrequency (RF) sensors, infrared signaling, or other means of wireless data transmission.
  • RF radiofrequency
  • electrical signals and “signals” both refer generally to any signal within a disclosed system, device, or method.
  • sensor data signal refers to any signal that carries commands or information generated by a medical device, such as a medical sensor.
  • power signal or “energy signal” refers to any signal that provides power to a medical device, such as a sensor.
  • a “signal” may comprise both a data signal and a power signal.
  • Sensor data signals may be fully or primarily carried out at the external device 110, or alternatively may be at least partially carried out at one or more other external devices communicatively connected to the external device 110, such as at a remote server or distributed network. Additionally or alternatively, sensor data signals may be processed at the coupling device 104, on the wire 102, or at some combination of devices within the gui dewire system 100. Sensor data signals may include, for example, image data, location data, and/or various types of sensor data (as related to fluid flow, fluid pressure, presence/levels of various gases or biological components, temperature, other physical parameters, and the like).
  • one or more sensors may be coupled to the wire 102, and the one or more sensors can operate to send data signals through the wire 102 to the coupling device 104. Additionally, or alternatively, the coupling device 104 may operate to send power or signals to the one or more sensors.
  • FIG. 2 is an overview of a catheter system 200 that may incorporate one or more of the features described herein.
  • the catheter system 200 may be similar to the guidewire system 100 in many respects, and the above description related to the gui dewire system 100 is also applicable here except where differences are specified.
  • the catheter system 200 includes a catheter 202 and a proximal device 204 (which may also be referred to herein as “the power and data coupling device 204” or just “the coupling device 204”).
  • the coupling device 204 includes a control unit 212 (shown enlarged and in schematic form) that includes a power source 214, data signal processor 216, and optionally a transmitter 218.
  • the transmitter 218 enables wireless communication to the external device 110 (or multiple such devices) as described above with respect to Figure 1.
  • the catheter 202 may also be referred to as a type of elongated conductive member.
  • the data signal processor 216 is configured to receive sensor data signals, sent through the catheter 202, from one or more sensors 121, 220 associated with the catheter 202.
  • the power source 214 is configured to transmit power through the catheter 202 to power the one or more sensors 121, 220 and/or other components of the catheter 202.
  • the power source 214 may include an on-board power source, such as a battery or battery pack, and/or may include a wired connection to an outside power source.
  • the one or more sensors 220 may be located at any suitable position on the catheter 202 but will typically be disposed at the distal section of the catheter 202 expected to reach the targeted anatomy. Sensors 220 may be coupled to the catheter 202 by employing bonding, molding, co extrusion, welding and/or gluing techniques, for example.
  • Power lines and/or data lines 201 extend along the length of the catheter 202 to the one or more sensors 220.
  • a “power line” and/or “data line” refer to any electrically conductive pathway (e.g., traces) within the medical device.
  • multiple power and/or data lines 201 may be utilized, preferred embodiments are configured to send both power and data on a single line and/or manage sensor data signals from multiple sensors on a single line. This reduces the number of lines that must be routed through the structure of the catheter 202 and more effectively utilizes the limited space of the device, as well as reducing the complexity of the device and the associated risk of device failure.
  • an “un-wired sensor” in either the guidewire system 100 or in the catheter system 200 refers to a sensor that does not have a physically continuous connection, via one or more power lines and/or data lines, that connect the sensor to a power source and/or an external device 110.
  • the proximal device 204 may include one or more ports to facilitate the introduction of fluids (e.g., medications, nutrients) into the catheter 202.
  • the catheter 202 may be sized and configured to be temporarily inserted in the body, permanently implanted in the body, or configured to deliver an implant in the body.
  • the catheter 202 is a peripherally inserted central catheter (PICC) line, typically placed in the arm or leg of the body to access the vascular system of the body.
  • PICC peripherally inserted central catheter
  • the catheter 202 may also be a central venous catheter, an IV catheter, coronary catheter, stent delivery catheter, balloon catheter, atherectomy type catheter, or IVUS catheter or other imaging catheter.
  • the catheter 202 may be a single-lumen or multi-lumen catheter.
  • Figure 3 A provides another view of the gui dewire system 100 of Figure 1.
  • the gui dewire system 100 shares certain features with the catheter system 200, and the description of common parts is therefore applicable to the guidewire system 100 as well.
  • the guidewire system 100 includes a control unit 112 (shown enlarged and in schematic form) that includes a power source 114, data signal processor 116, and optionally a transmitter 118.
  • the transmitter 118 enables wireless communication to the external device 110 (or multiple such devices) as described above.
  • the data signal processor 116 is configured to receive sensor data signals, sent through the wire 102, from one or more sensors 121 associated with the guidewire 102.
  • the power source 114 is configured to transmit power through the wire 102 to power the one or more sensors 121 and/or other components of the wire 102.
  • the power source 114 may include an on-board power source, such as a battery or battery pack, and/or may include a wired connection to an outside power source.
  • the one or more sensors 121 may be located at any suitable position on the wire 102 but will typically be disposed at the distal section expected to reach the targeted anatomy.
  • distal section refers to the distal-most 30 cm of the device, the distal-most 20 cm of the device, the distal-most 15 cm of the device, the distal -most 10 cm of the device, or to a range using any two of the foregoing values as endpoints.
  • the “intermediate section” may be considered as roughly the middle third of the device, and the “proximal section” or “proximal portion” may be considered as roughly the proximal third of the device.
  • the guidewire system 100 is configured to send these power and data signals through the actual wire 102 itself.
  • multiple power and/or data signals e.g., data signals from multiple sensors 121
  • Power and/or data signals can also be sent in a “continuous” fashion. That is, the power and/or data signals can have a sufficiently high sampling rate such that the information is provided to the user within time frames that are practically “real-time”. For most applications, this will include sampling rates of approximately 5 seconds or less, 3 seconds or less, 1 second or less, or sub-second sampling rates.
  • Using the wire 102 itself to send power and/or data signals through the device provides several benefits. For example, using the wire 102 to transmit these signals reduces or eliminates the need to run other connection lines along the wire 102 to connect the sensors 121 to the proximal portion and/or to deliver power to the sensors.
  • gui dewires inherently involve strict dimensional and performance (e.g., torqueability, bending, pushability, stiffness, etc.) limitations and have limited space to work in, the ability to reduce or eliminate extraneous components frees up limited space and allows greater design flexibility. Reducing or eliminating the use of additional connection lines also reduces the overall complexity of the device and thereby reduces the risk of component failure, leading to a more robustly functional device.
  • the one or more sensors 121 of the guidewire system 100 and/or the one or more sensors 220 of the catheter system 200 may include a pressure sensor, flow sensor, imaging sensor, or a component detection sensor, for example.
  • a pressure sensor (or multiple pressure sensors) may be sized and configured to sense changes in pressure in the environment.
  • a flow sensor (or multiple flow sensors) may be sized and configured to sense the fluid flow, such as velocity or other flow characteristics.
  • a detection sensor (or multiple detection sensors) may detect a proximity or distance to one or more detection nodes positioned external relative to the body.
  • An imaging sensor may gather various forms of imaging data.
  • the one or more sensors may additionally or alternatively be configured to sense the presence of biological components or measure physiological parameters in the targeted anatomical location (e.g., in the blood).
  • Example biological components that may be detected/measured include sugar levels, pH levels, CCh levels (CCh partial pressure, bicarbonate levels), oxygen levels (oxygen partial pressure, oxygen saturation), temperature, and other such substrates and physiological parameters.
  • the one or more sensors may be configured to sense the presence, absence, or levels of biological components such as, for example, immune system-related molecules (e.g., macrophages, lymphocytes, T cells, natural killer cells, monocytes, other white blood cells, etc.), inflammatory markers (e.g., C-reactive protein, procalcitonin, amyloid A, cytokines, alpha-l-acid glycoprotein, ceruloplasmin, hepcidin, haptoglobin, etc.), platelets, hemoglobin, ammonia, creatinine, bilirubin, homocysteine, albumin, lactate, pyruvate, ketone bodies, ion and/or nutrient levels (e.g., glucose, urea, chloride, sodium, potassium, calcium, iron/ferritin, copper, zinc, magnesium, vitamins, etc.), hormones (e.g., estradiol, follicle-stimulating hormone, aldosterone, progesterone,
  • Supporting electronics may include, for example, power regulators, converters, signal amplifiers, processing components such as application-specified integrated circuits (ASICs), field-programmable gate arrays (FPGAs), and the like.
  • the supporting electronics of the one or more sensors 121 are preferably positioned near the one or more sensors 121 themselves (e.g., at the distal section of the wire 102 on a substrate). This was beneficially found to reduce signal drift as compared to placing the supporting electronics at the proximal sections of the device.
  • Figure 3B illustrates an expanded view of the distal section of the guidewire system 100 of Figure 3 A, showing various sensors arranged thereon.
  • the one or more sensors 121, 220 include multiple pressure sensors 120 and ultrasound sensors 122. These sensors are positioned on a substrate 124 and the substrate 124 is positioned on the wire 102 in a manner that places the sensors at their respective desired positions.
  • the substrate 124 may be made of a somewhat flexible material (e.g., a suitable medical grade polymer) that allows wrapping, winding, or otherwise positioning the substrate 124 onto the wire 102.
  • the substrate 124 also includes flexible circuitry such as trace lines and/or one or more conductive contacts to couple the sensors to the underlying wire 102.
  • the substrate 124 can form a friction fit with the wire 102 and can additionally or alternatively be mechanically bonded to the wire 102.
  • the substrate 124 can be spread into what is essentially a 2-dimensional layout, which makes it much easier to appropriately position the sensors.
  • the 2-dimensional substrate 124, with sensors coupled thereto, can then be placed on the 3-dimensional cylindrical shape of the wire 102 more readily than placing each sensor separately onto the wire 102.
  • the various sensors can be directly placed on the 3-dimensional wire 102 without the benefit of a 2-dimensional substrate 124.
  • the various sensors can be placed on the substrate after the substrate has been applied to the 3-dimensional wire 102.
  • the illustrated embodiment also includes an outer member 126 (shown here with dashed lines) that can be positioned over the sensor-containing portion of the wire 102.
  • the outer member 126 may be formed from a suitable medical grade polymer (e.g., polyethylene terephthalate (PET) or polyether block amide (PEBA).
  • PET polyethylene terephthalate
  • PEBA polyether block amide
  • the outer member 126 can function to further constrain and maintain position of the sensors and/or to smooth over the outer surface for a more uniform outer diameter.
  • the outer member 126 may be applied by shrink-fitting a tube in place, by dip coating, and/or through other manufacturing methods known in the art. A hydrophilic coating may also be added to the outer surface of the device.
  • Figure 3C illustrates another, schematic view of the distal section of the guidewire system 100 shown in Figure 3A, showing multiple pressure sensors 120 and multiple ultrasound sensors 122 disposed on the substrate 124, which is positioned on the wire 102.
  • the distal-most section of the device can also include a coil 128 and/or atraumatic tip 130.
  • the coil 128 may be a single coil or multiple connected or interwoven coils.
  • a polymer material may be positioned on or applied to the distal section of the wire 102.
  • a polymer material may be positioned on or applied to the distal section of the wire 102.
  • the atraumatic tip 130 forms a sphere or other curved shape to protect against trauma potentially caused by the distal portion of the wire 102.
  • the atraumatic tip 130 may be formed from a polymer adhesive material and/or solder, for example.
  • the wire 102 can include a grind profile such that more distal sections of the wire 102 progress to smaller diameters.
  • the wire 102 may progress to a diameter of about 0.002 inches at the distal end.
  • the distal end of the wire 102 may also be flattened to form a standard “ribbon” shape.
  • the illustrated embodiment also includes an energy harvester 132.
  • the energy harvester is configured to convert power signals traveling within the wire 102 into regulated DC voltages suitable for the sensors.
  • the energy harvester 132 can also provide other electrical regulation functions such as cutting power to the sensors during a fault or brownout, for example.
  • the energy harvester 132 is considered a subcomponent of the one or more sensors 121. As such, unless stated otherwise, references to the one or more sensors 121 also refer to the associated circuitry, such as the energy harvester 132.
  • the energy harvester is configured to provide control functions for the one or more sensors 121.
  • a particular signal can be communicated from the power and data coupling device 104 to the energy harvester.
  • the particular signal may comprise a chirp, an impulse function, or some signal at a particular frequency channel.
  • the energy harvester maps the particular signal to a predetermined command and then acts upon that predetermined command.
  • a particular signal may map to a command to cut DC power to one or more rails that are powering one or more sensors.
  • the energy harvester stops providing power to the one or more sensors causing the one or more sensors to turn off. Any number of different signals may be mapped to any number of different commands.
  • a circuit other than the energy harvester receives, interprets, and/or acts upon the signals.
  • the length of the wire 102 that includes the substrate 124 may be about 3 cm to about 30 cm, or more typically about 5 cm to about 15 cm, though these lengths may be varied according to particular application needs. As explained below with respect to the example of Figures 4A through 4D, in preferred embodiments the length of the sensor arrangement substantially spans the expected length of lesions/stenoses or other target anatomy.
  • the linear arrangement of pressure sensors 120 can be utilized to provide pressure mapping at targeted anatomy without the need to move the wire 102. Multiple measurements from multiple sensors may be conducted simultaneously and/or continuously.
  • the arrangement of pressure sensors 120 can also be utilized to measure pulse wave velocity (PWV) (e.g., by determining a series of wave peaks and measuring time between peaks) and/or to provide spatial tracking of a pulse waveform.
  • PWV pulse wave velocity
  • Figures 4A through 4D illustrate a sequence showing use of the guidewire system 100 to effectively guide positioning and deployment of a medical device at a targeted anatomical location.
  • the guidewire system 100 is used to properly position a stent 406 at a targeted stenosis 404.
  • Figure 4A shows the wire 102 with pressure sensors 120 (other components removed for better visibility) positioned within a vessel 402.
  • the wire 102 is routed through the vessel 402 to a position where the arrangement of pressure sensors 120 span or at least substantially coincide with the stenosis 404.
  • the linear arrangement of the pressure sensors 120 allows the wire 102 to be effectively positioned coincident with the stenosis 404 because the stenosis 404 will cause pressure differences at that portion of the vessel 402, and the user can advance the wire 102 until those pressure differences are read by the sensors 120.
  • the vessel 402 is a coronary artery
  • the pressure distal of the stenosis 404 will be somewhat lower than the pressure proximal of the stenosis 404.
  • the wire 102 can be advanced until one or more of the distal-most pressure sensors reach the region of different pressure (e.g., somewhat lower pressure in a coronary vessel stenosis).
  • the stent 406 is then delivered over the wire 102 toward the stenosis 404.
  • the position of the stent 406 relative to the wire 102 can be determined based on readings from the pressure sensors 120. For example, as the stent 406 is moved distally it will sequentially begin to pass over the pressure sensors 120, causing a change in the pressure reading of the sensors and thereby allowing the user to determine the position of the stent 406 relative to the wire 102.
  • Figure 4B shows the stent 406 positioned farther within the vessel 402 to its target location.
  • the delivery catheter 408 is also shown.
  • the delivery catheter 408 may be a balloon catheter, or the stent 406 may be a self-expanding stent.
  • Other stent types and stent delivery means as known in the art may be utilized.
  • Proper positioning of the stent 406 is possible because the position of the wire 102 relative to the stenosis 404 is known based upon readings received from the pressure sensors 120. Additionally, determining where the stent 406 is positioned relative to the wire 102 thus allows determination of the position of the stent 406 relative to the stenosis 404.
  • the stent 406 may be deployed as shown in Figure 4C. After deployment, the wire 102 may remain in place for a time during post-stent assessment. The wire 102 may then be retracted from the vessel 402, leaving the stent 406 in place as shown in Figure 4D.
  • the gui dewire system 100 can therefore provide a localized reference frame (i.e., a reference frame within the localized anatomy of the target) for guiding positioning of a medical device.
  • a localized reference frame i.e., a reference frame within the localized anatomy of the target
  • the localized reference frame defined by the distal section of the guidewire system 100 moves substantially with the target anatomy in which it is placed, removing many positioning complications and thereby improving the ability to position stents and/or other medical devices.
  • This localized reference frame is also relatively stable because the wire 102 does not need to be moved to make sequential measurements.
  • the sensors 120 are able to continuously and simultaneously provide sensor data signals during the placement of the stent, or other medical device. This allows a medical practitioner to guide the stent, or other medical device, in real time to the desired position within the body. That is, the linear arrangement of the sensors 120 allows multiple measurements without the need to “pull back” the wire 102 to make measurements in other positions.
  • the system may be configured to provide multiple measurements from multiple sensors simultaneously, eliminating the need to even do a “virtual pull back” of sequential measurements along the length of sensors.
  • the procedure illustrated in Figures 4A through 4D is one example of using the guidewire system 100 for localization within target anatomy.
  • the guidewire system 100 and/or catheter system 200 may be utilized in other applications where the localization features of the system would be beneficial.
  • localization features described herein may be utilized to aid in proper placement of a PICC catheter or central venous catheter at a targeted site such as the cavoatrial junction.
  • the Conductive Elongated Member As A Power And Data Conductive Path
  • Figure 5 illustrates an extension wire 500 being added to the wire 102.
  • the depicted extension wire 500 may be coupled to the wire 102 through any number of different physical couplings, including, but not limited to, a threaded connection, a magnetic connection, a press-fit connection, a snap connection, or an adhesive connection.
  • the resulting physical coupling results in a continuous conductive pathway from the extension wire 500 to the wire 102.
  • both the extension wire 500 and the wire 102 may be jointly considered and referred to as the “wire 102.” More specifically, electrical signals applied to the extension wire 500 will propagate from the extension wire 500 to the wire 102. Accordingly, unless stated otherwise, all descriptions of the wire 102 provided herein also apply when an extension wire 500 is attached to the wire 102. Additionally, it will be appreciated that any elongated conductive member disclosed herein may comprises multiple extensions that are removably attached to each other.
  • the guidewire system 100 comprises a medical device system for concurrent power and data transfer.
  • the guidewire system 100 may comprise a type of elongated conductive member.
  • the elongated conductive member comprises a proximal portion and a distal portion. At least a portion of the elongated conductive member is configured for insertion within an intraluminal space. Additionally, both the proximal portion and the distal portion of elongated conductive member may be electrically conductive.
  • the elongated conductive member comprises a single conductive pathway extending from the proximal portion to the distal portion.
  • the single conductive pathway may comprise a stainless-steel wire 102 within the guidewire system 100.
  • the elongated conductive member comprises multiple conductive pathways extending from the proximal portion to the distal portion.
  • the catheter system 200 may comprise multiple wires integrated within the structure of the catheter 202.
  • the elongated conductive member comprises a first conductive pathway for use as a power channel and a second conductive pathway for user as a signal channel, both the first conductive pathway and the second conductive pathway extending from the proximal portion to the distal portion.
  • one or more sensors 121 may be in electrical connection with the elongated conductive member.
  • the medical device which includes the elongated conductive member, may also comprise one or more electrical components that are physically configured such that when activated, the one or more electrical components cause the medical device system to perform various actions.
  • the one or more electrical components may comprise discrete circuit components, digital circuit components, analog circuit components, processor(s), or any combination thereof.
  • the one or more electrical components may be integrated within control unit 112 or 212, within the external device 110, and/or on the elongated member. Activating the one or more electrical components may comprise providing power to the one or more electrical components.
  • the one or more electrical components cause the medical device system to allocate a signal space into a plurality of unique contiguous segments.
  • Each segment within the signal space comprises a portion of the signal space that may be used for the purposes of communicating data, power, or other information.
  • the signal space may comprise a frequency-domain space, a time-domain space, or any other space capable of carrying a signal.
  • allocating the signal space may comprise dynamically identifying signal channels of interest.
  • allocating the signal space may comprise providing electrical components that are configured to statically define the signal space.
  • Figures 6A and 6B illustrate different embodiments of an electrical schematic diagram of the medical device.
  • Figure 7 illustrates channels configured for utilization by the medical device.
  • the one or more electrical components uniquely allocate each of the plurality of unique contiguous segments to one of (i) one or more power channels or (ii) one or more signal channels.
  • uniquely allocating refers to each contiguous segment being allocated as either a power channel or a signal channel.
  • Figure 6A depicts a schematic of a frequency-based medical device system.
  • the one or more electrical components cause the medical device system to allocate a signal space into the plurality of unique contiguous segments by designating a plurality of unique contiguous regions of frequency (e.g., 710(a-e)).
  • the one or more electrical components further cause the medical device system to uniquely allocate each of the plurality of unique contiguous regions of frequency to one of (i) the one or more power channels or (ii) the one or more signal channels.
  • Figure 6B depicts a schematic of a time-based medical device system.
  • the one or more electrical components cause the medical device system to allocate a signal space into the plurality of unique contiguous segments by designating a plurality of unique contiguous time slots (e.g., 710(a-e)).
  • the one or more electrical components further cause the medical device system to uniquely allocate each of the plurality of unique contiguous time slots to one of (i) the one or more power channels or (ii) the one or more signal channels.
  • Figure 7 illustrates that the signal space 700 may comprise multiple unique contiguous segments in the form of multiple frequency channels 710(a-e).
  • Each frequency channel may be allocated as a power channel for providing power to the electronic devices located on the elongated conductive member or may be allocated as a signal channel for receiving data from the electronic devices on the elongated conductive member.
  • the electronic devices comprise sensors 121, 220.
  • the signal space 700 may comprise multiple unique contiguous segments in the form of time slots 710(a-e). Each time slot may be defined based on a clock. Additionally, each time slot may be allocated as a power channel for providing power to electronic devices located on the elongated conductive member or may be allocated as a signal channel for receiving data from the electronic devices on the elongated conductive member.
  • Figures 6A and 6B depict an elongated conductive member 600 that is coupled to a power source 610.
  • the power source 610 may be configured to send electrical signals, via the elongated conductive member 600, to one or more sensors 121(a- c) that are in electrical connection with the elongated conductive member 600.
  • the power source 610 may send AC electrical signals within a particular unique contiguous segment, such as frequency channel 710a.
  • the elongated conductive member 600 is capacitively coupled to the power source 610 such that no direct physical contact is present between the elongated conductive member 600 and the power source 610.
  • a direct physical contact may be present between the elongated conductive member 600 and the power source 610.
  • an elongated conductive member in the form of the wire 102, is shown to include an energy harvester 132.
  • an energy harvester 132 refers to an electronic circuit that is configured to harvest energy from an allocated power channel.
  • an energy harvester 132 may comprise an electronic circuit to harvest energy from the electrical signals within at least one of the one or more power channels - in this example, frequency channel 710a. The harvested energy is then provided to the at least one of the one or more sensors 121.
  • the power source 610 transmits energy within the at least one of the one or more power channels and provides power to all of the one or more sensors 121 through the at least one of the one or more power channels.
  • each sensor of the one or more sensors harvests energy from the particular unique contiguous segment of the signal space that is represented by the at least one of the one or more power channels.
  • the power source 610 transmits energy within a first power channel of the one or more power channels (e.g., 710a), wherein the first power channel of the one or more power channels comprises a first unique contiguous segment of the signal space. Additionally, the power source 610 transmits energy within a second power channel of the one or more power channels (e.g., 710b), wherein the second power channel of the one or more power channels comprises a second unique contiguous segment of the signal space.
  • the elongated conductive member 600 then provides energy to a first subset of the one or more sensors through the first power channel of the one or more power channel.
  • Each sensor of the first subset of the one or more sensors is configured to harvest energy from the first unique contiguous segment of the signal space.
  • the elongated conductive member 600 provides energy to a second subset of the one or more sensors through the second power channel of the one or more power channels.
  • Each sensor of second subset of the one or more sensors is configured to harvest energy from the second unique contiguous segment of the signal space.
  • the elongated conductive member 600 provides different sets of sensors power through independent power channels. This provides a user with the ability to selectively activate all of the sensors simultaneously or to only activate subsets of the sensors at different times.
  • the one or more sensors may comprise at least a first sensor of a first type and a second sensor of a second, different type. Accordingly, in at least one embodiment, a user can activate sensors based upon sensor type. As disclosed herein, this selective control of the sensors and communication with the sensors may be performed over a single conductive path, such as wire 102.
  • At least one sensor from the one or more sensors 121 begins to receive the harvested energy, the at least one sensor will begin to generate data signals based upon readings received by the at least one sensor.
  • Figure 6A depicts a set of sensors 121 (a-c) that each transmit along the elongated conductive member 600 at a particular frequency. For example, sensor 121a is summed with any other data signals that are each in their own frequency.
  • this system allows multiple data signals to be communicated simultaneously in parallel via the elongated conductive member 600.
  • Figure 6A shows that the one or more electrical components cause the medical device system to isolate transmitted data signals from at least one of the one or more signal channels.
  • the data signals are transmitted via the elongated conductive member 600 and generated by the one or more sensors 121(a-c).
  • the elongated conductive member 600 is also coupled with a power and data coupling device 630 (also referred to as a proximal device 104 in Figure 1 and a proximal device 204 in Figure 2).
  • the elongated conductive member 600 is capacitively coupled to the power and data coupling device 630 such that no physical connection is present between the elongated conductive member 600 and the power and data coupling device 630.
  • a physical connection may be present between the elongated conductive member 600 and the power and data coupling device 630.
  • the power and data coupling device 630 comprises multiple frequency filters 632(a-c) that allow it to isolate the respective data signals that are communicated along the elongated conductive member 600. Additionally, or alternatively, in at least one embodiment, the power and data coupling device 630 isolates multiple transmitted data signals in parallel. Each data signal from the multiple data signals is associated with a different unique contiguous region of frequency selected from the plurality of unique contiguous regions of frequency.
  • the power and data coupling device 630 further comprises a transmitter 640 that is configured to communicate the isolated data signals to the external device 110 for display and/or processing.
  • Figure 6B depicts a set of sensors 121(a-c) that each transmit along the elongated conductive member 600 within a time slot.
  • each sensor 121(a-c) communicates data signals via the elongated conductive member 600 at a particular time slot that is determined by a clock signal 650a.
  • Figure 6B shows that the elongated conductive member 600 is also coupled with a power and data coupling device 630.
  • the power and data coupling device 630 comprises a filter 660 that is in communication with a clock 650b, which clock is synchronized with clock 650a.
  • the combination of the synchronized clocks 650a, 650b and the filter 660 allow the power and data coupling device 630 to isolate the data signals within each respective time slot.
  • the power and data coupling device 630 further comprises a transmitter 640 that is configured to communicate the isolated data signals to the external device 110 for display and/or processing.
  • the power and data coupling device 630 comprises an indicator for indicating information relating to the operation of the power and data coupling device 630 or the conductive elongated member.
  • the indicator may comprise an audible alert, a haptic alert, a visual alert (e.g., a light), a communication to an external device that performs an alert function and/or any other type of alert.
  • the transmitter 640 may comprise some processing capability that can detect an interruption in power traveling through the power and data coupling device 104 and/or a poor quality of data signals being received by the power and data coupling device 104. In such cases, the power and data coupling device 104 may cause an indication of an alert to be issued in order to notify a user of the issue.
  • the signal space 700 may comprise a multiple dimensional signal space 700.
  • the signal space 700 may utilize a QPAM, QPSK, Viterbi codes, or other signal space.
  • Figures 8A-8C depicts various signal schematic diagrams of the guidewire system 100.
  • Similar electrical circuits could also be integrated into any elongated conductive member 600, including a catheter 202.
  • the schematic of Figure 8A depicts a circuit for gathering and displaying arterial pressure.
  • the arterial pressure 802 is gathered by a capacitive pressure sensor 806, one will appreciate that any number of different pressure sensors types may alternatively be used.
  • the capacitive pressure sensor 806 utilizes a capacitance-to-voltage converter 804 to generate a particular voltage based upon the particular capacitance that is measured by the capacitive pressure sensor 806.
  • the particular voltage is processed through a voltage-controlled oscillator (“VCO”) 808 to generate a particular waveform.
  • VCO voltage-controlled oscillator
  • the particular waveform is then transmitted via the elongated conductive member 600 from the distal portion of the elongated conductive member 600 to the proximal portion of the elongated conductive member 600.
  • the elongated conductive member 600 comprises the wire 102 within the guidewire system 100.
  • the particular waveform is transmitted within a particular unique contiguous segment of a signal space, such as a signal channel as defined by a particular frequency channel.
  • a capacitive pickup 810 detects the particular waveform within the particular unique contiguous segment of a signal space.
  • the capacitive pickup 810 is integrated within the power and data coupling device 630.
  • the power and data coupling device 630 may be in capacitive communication with the elongated conductive member 600 through changing electric fields.
  • the capacitive pickup 810 communicates the detected waveform to a phase-lock loop (PLL) 812 which is then turned into a voltage 814.
  • the resulting voltage 814 can then be processed and displayed 816 as a pressure reading to an end-user.
  • PLL phase-lock loop
  • Figure 8B depicts a circuit for gathering and displaying a pulse echo.
  • the pulse echo is gathered by an ultrasound pulse echo sensor 818.
  • the ultrasound pulse echo sensor 818 generates an amplitude modulated wave 820.
  • a voltage envelope versus time 822 is then created.
  • the voltage envelope versus time is created using a Hilbert transform circuit.
  • the resulting signal is processed through a voltage-controlled oscillator (“VCO”) 824 to generate a representative signal.
  • VCO voltage-controlled oscillator
  • the representative signal is then transmitted via the elongated conductive member 600 from the distal portion of the elongated conductive member 600 to the proximal portion of the elongated conductive member 600.
  • the elongated conductive member 600 comprises the wire 102 within the guidewire system 100.
  • the representative signal is transmitted within a particular unique contiguous segment of a signal space, such as a signal channel as defined by a particular frequency channel.
  • a capacitive pickup 826 detects the representative signal within the particular unique contiguous segment of a signal space.
  • the capacitive pickup 826 is integrated within the power and data coupling device 630. Additionally, the power and data coupling device 630 may be in capacitive communication with the elongated conductive member 600 through changing electric fields.
  • the capacitive pickup 826 communicates the detected signal to a phase-lock loop (PLL) 828 which is then turned into a voltage 830. The resulting voltage 830 can then be processed and displayed 832 as a pulse echo reading to an end-user.
  • PLL phase-lock loop
  • Figure 8C depicts a circuit for providing power to the one or more sensors 121.
  • Figure 8C starts from the proximal portion of the elongated conductive member 600 and transmits towards the distal portion of the elongated conductive member 600.
  • a frequency generation circuit 834 creates a power signal within a particular unique contiguous segment of a signal space, the particular unique contiguous segment comprising a particular power channel.
  • the generated AC signal is communicated to a power amplifier 836 to generate a particular AC power signal within the particular power channel.
  • the AC power signal is capacitively coupled 838 to the elongated conductive member 600 and then transmitted, via the elongated conductive member 600, to the one or more sensors 121 at the distal portion of the elongated conductive member 600. [0100] Once the AC power signal reaches the distal portion of the elongated conductive member 600, the AC power signal is rectified 840 and processed through a qualification/smoothing circuit 842. The resulting DC power signal 844 is then provided to the one or more sensors 846, 121, 220.
  • each of the above-described circuits in Figures 8A-8C utilize the capacitive coupling between the elongated conductive member 600 and the power and data coupling device 630.
  • the describes sensors can be provided power and can communicate data to an external device 110 without requiring a physical connection between the power and data coupling device 630 and the elongated conductive member 600.
  • the lack of such a physical connection provides significant technical benefits to a user. For example, the user is no longer constrained by the presence of physical cords connecting to the elongated conductive member 600.
  • the user can feed medical devices, such as stents and catheters, over the wire 102 without having to remove or power down the wire 102.
  • medical devices such as stents and catheters
  • Such an ability allows the user to maintain uninterrupted sensor data from within the patient while placing the medical device onto the wire 102 and while placing the medical device within the human body.
  • Figure 9 illustrates a flow chart of a method 900 for concurrent power and data transfer in a medical device.
  • Method 900 includes an act 910 of providing an elongated conductive member.
  • Act 910 comprises providing an elongated conductive member, at least a portion thereof configured for insertion within an intraluminal space, the elongated conductive member comprising a proximal portion and a distal portion configured to conduct electrical signals.
  • the elongated conductive member may comprise a wire 102 within a guidewire system 100, a catheter 202 within a catheter system 200, or any other elongated conductive member suitable for insertion into an intraluminal space.
  • Method 900 also includes an act 920 of allocating a signal space.
  • Act 920 comprises allocating a signal space into a plurality of unique contiguous segments.
  • a signal space 700 may be segmented into time slots, frequency channels, or any other segmentation.
  • method 900 includes an act 930 of allocating contiguous segments to power channels or signal channel.
  • Act 930 comprises uniquely allocating each of the plurality of unique contiguous segments to one of (i) one or more power channels or (ii) one or more signal channels.
  • the signal space may be segmented such that a one or more particular channels are used to provide power to the one or more sensors, while one or more other channels are used to receive data signals from the one or more sensors.
  • Method 900 includes an act 940 of sending electrical signals.
  • Act 940 comprises sending the electrical signals, via the elongated conductive member, to one or more sensors that are in electrical connection with the elongated conductive member.
  • a power and data coupling device 630 can send electrical signals within power channels to the one or more sensors.
  • method 900 includes an act 950 of harvesting energy from the power channels.
  • Act 950 comprises harvesting energy from the electrical signals within at least one of the one or more power channels.
  • the one or more sensors can utilize an energy harvester 132 to harvest power from the power channels and provide that power to the one or more sensors 121.
  • method 900 includes an act 960 of isolating transmitted data signals.
  • Act 960 comprises isolating transmitted data signals from at least one of the one or more signal channels, the data signals transmitted via the elongated conductive member and the data signals generated by the one or more sensors.
  • the power and data coupling device 630 comprises filters that are configured to isolate the data signals from each other.
  • a method for concurrent power and data transfer in a medical device comprising: providing an elongated conductive member, at least a portion thereof configured for insertion within an intraluminal space, the elongated conductive member comprising a proximal portion and a distal portion configured to conduct electrical signals; allocating a signal space into a plurality of unique contiguous segments; uniquely allocating each of the plurality of unique contiguous segments to one of (i) one or more power channels or (ii) one or more signal channels; sending the electrical signals, via the elongated conductive member, to one or more sensors that are in electrical connection with the elongated conductive member; harvesting energy from the electrical signals within at least one of the one or more power channels; and isolating transmitted data signals from at least one of the one or more signal channels, the data signals transmitted via the elongated conductive member and the data signals generated by the one or more sensors.
  • Clause 2 The method as recited in any preceding clause, wherein both the proximal portion and the distal portion are conductive.
  • Clause 3 The method as recited in any preceding clause, wherein the elongated conductive member comprises a single conductive pathway extending from the proximal portion to the distal portion.
  • harvesting energy from at least one of the one or more power channels further comprises: transmitting energy within the at least one of the one or more power channels, wherein the at least one of the one or more power channels comprises a particular unique contiguous segment of the signal space; and providing power to all of the one or more sensors through the at least one of the one or more power channels, each sensor of the one or more sensors configured to receive power from the particular unique contiguous segment of the signal space.
  • harvesting energy from at least one of the one or more power channels further comprises: transmitting energy within the at least one of the one or more power channels, wherein the at least one of the one or more power channels comprises a first unique contiguous segment of the signal space; transmitting energy within a second power channel of the one or more power channels, wherein the second power channel of the one or more power channels comprises a second unique contiguous segment of the signal space; providing power to a first subset of the one or more sensors through the at least one of the one or more power channels, each sensor of the first subset of the one or more sensors configured to receive energy from the first unique contiguous segment of the signal space; and providing power to a second subset of the one or more sensors through the second power channel of the one or more power channels, each sensor of second subset of the one or more sensors configured to receive energy from the second unique contiguous segment of the signal space.
  • allocating the signal space into the plurality of unique contiguous segments comprises: designating a plurality of unique contiguous time slots; and uniquely allocating each of the plurality of unique contiguous segments to one of (i) the one or more power channels or (ii) the one or more signal channels, comprises: uniquely allocating each of the plurality of unique contiguous time slots to one of (i) the one or more power channels or (ii) the one or more signal channels.
  • allocating the signal space into the plurality of unique contiguous segments comprises: designating a plurality of unique contiguous regions of frequency; and uniquely allocating each of the plurality of unique contiguous segments to one of (i) the one or more power channels or (ii) the one or more signal channels, comprises: uniquely allocating each of the plurality of unique contiguous regions of frequency to one of (i) the one or more power channels or (ii) the one or more signal channels.
  • Clause 9 The method as recited in any preceding clause, wherein isolating transmitted data signals from at least one of the one or more signal channels comprises: isolating multiple transmitted data signals in parallel, each data signal from the multiple data signals being associated with a different unique contiguous region of frequency selected from the plurality of unique contiguous regions of frequency.
  • Clause 10 The method as recited in any preceding clause, wherein the one or more sensors comprise at least a first sensor of a first type and a second sensor of a second, different type.
  • Clause 11 The method as recited in any preceding clause, wherein sending power, via the elongated conductive member, to the one or more sensors that are in electrical connection with the elongated conductive member comprises sending AC power.
  • a medical device system for concurrent power and data transfer comprising: an elongated conductive member, at least a portion thereof configured for insertion within an intraluminal space, the elongated conductive member comprising a proximal portion and a distal portion; one or more sensors that are in electrical connection with the elongated conductive member; and one or more electrical components that are physically configured such that when activated, the one or more electrical components cause the medical device system to perform at least the following: allocate a signal space into a plurality of unique contiguous segments, uniquely allocate each of the plurality of unique contiguous segments to one of (i) one or more power channels or (ii) one or more signal channels, send the electrical signals, via the elongated conductive member, to one or more sensors that are in electrical connection with the elongated conductive member; harvest energy from the electrical signals within at least one of the one or more power channels, and isolate transmitted data signals within at least one of the one or more signal channels, via the e
  • Clause 13 The medical device system as recited in any preceding clause, wherein both the proximal portion and the distal portion are conductive.
  • Clause 14 The medical device system as recited in any preceding clause, wherein the elongated conductive member comprises a single conductive pathway extending from the proximal portion to the distal portion.
  • Clause 15 The medical device system as recited in any preceding clause, wherein the elongated conductive member comprises multiple extensions that are removably attached to each other.
  • harvesting energy from at least one of the one or more power channels further comprises: transmitting energy within the at least one of the one or more power channels, wherein the at least one of the one or more power channels comprises a particular unique contiguous segment of the signal space; and providing power to all of the one or more sensors through the at least one of the one or more power channels, each sensor of the one or more sensors receiving energy from the particular unique contiguous segment of the signal space.
  • harvesting energy from at least one of the one or more power channels further comprises: transmitting energy within the at least one of the one or more power channels, wherein the at least one of the one or more power channels comprises a first unique contiguous segment of the signal space; transmitting energy within a second power channel of the one or more power channels, wherein the second power channel of the one or more power channels comprises a second unique contiguous segment of the signal space; providing energy to a first subset of the one or more sensors through the at least one of the one or more power channel, each sensor of the first subset of the one or more sensors configured to receive energy from the first unique contiguous segment of the signal space; and providing energy to a second subset of the one or more sensors through the second power channel of the one or more power channels, each sensor of second subset of the one or more sensors configured to receive energy from the second unique contiguous segment of the signal space.
  • allocating the signal space into the plurality of unique contiguous segments comprises: designating a plurality of unique contiguous time slots; and uniquely allocating each of the plurality of unique contiguous segments to one of (i) the one or more power channels or (ii) the one or more signal channels, comprises: uniquely allocating each of the plurality of unique contiguous time slots to one of (i) the one or more power channels or (ii) the one or more signal channels.
  • allocating the signal space into the plurality of unique contiguous segments comprises: designating a plurality of unique contiguous regions of frequency; and uniquely allocating each of the plurality of unique contiguous segments to one of (i) the one or more power channels or (ii) the one or more signal channels, comprises: uniquely allocating each of the plurality of unique contiguous regions of frequency to one of (i) the one or more power channels or (ii) the one or more signal channels.
  • Clause 20 The medical device system as recited in any preceding clause, wherein isolating transmitted data signals from at least one of the one or more signal channels comprises: isolating multiple transmitted data signals in parallel, each data signal from the multiple data signals being associated with a different unique contiguous region of frequency selected from the plurality of unique contiguous regions of frequency.
  • Clause 21 The medical device system as recited in any preceding clause, wherein the one or more sensors are in electrical connection with the elongated conductive member through a substrate, the substrate comprising electrical pathways connecting individual components within the one or more sensors.
  • Clause 22 The medical device system as recited in any preceding clause, wherein the elongated conductive member comprises a first conductive pathway for use as a power channel and a second conductive pathway for user as a signal channel, both the first conductive pathway and the second conductive pathway extending from the proximal portion to the distal portion.
  • a computer-readable media comprising one or more physical computer-readable storage media having stored thereon computer-executable instructions that, when executed at one or more processors, cause a computer system to perform a method for concurrent power and data transfer in a single-member medical device, the method comprising: providing an elongated conductive member, at least a portion thereof configured for insertion within an intraluminal space, the elongated conductive member comprising a proximal portion and a distal portion configured to conduct electrical signals; allocating a signal space into a plurality of unique contiguous segments, uniquely allocating each of the plurality of unique contiguous segments to one of (i) one or more power channels or (ii) one or more signal channels, sending the electrical signals, via the elongated conductive member, to one or more sensors that are in electrical connection with the elongated conductive member; harvesting energy from the electrical signals within at least one of the one or more power channels, and isolating transmitted data signals within at least one of the one or
  • the methods may be practiced by a computer system including one or more processors and computer-readable media such as computer memory.
  • the computer memory may store computer-executable instructions that when executed by one or more processors cause various functions to be performed, such as the acts recited in the embodiments.
  • Computing system functionality can be enhanced by a computing systems’ ability to be interconnected to other computing systems via network connections.
  • Network connections may include, but are not limited to, connections via wired or wireless Ethernet, cellular connections, or even computer to computer connections through serial, parallel, USB, or other connections.
  • the connections allow a computing system to access services at other computing systems and to quickly and efficiently receive application data from other computing systems.
  • cloud computing may be systems or resources for enabling ubiquitous, convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, services, etc.) that can be provisioned and released with reduced management effort or service provider interaction.
  • configurable computing resources e.g., networks, servers, storage, applications, services, etc.
  • a cloud model can be composed of various characteristics (e.g., on-demand self-service, broad network access, resource pooling, rapid elasticity, measured service, etc.), service models (e.g., Software as a Service (“SaaS”), Platform as a Service (“PaaS”), Infrastructure as a Service (“IaaS”), and deployment models (e.g., private cloud, community cloud, public cloud, hybrid cloud, etc.).
  • service models e.g., Software as a Service (“SaaS”), Platform as a Service (“PaaS”), Infrastructure as a Service (“IaaS”)
  • deployment models e.g., private cloud, community cloud, public cloud, hybrid cloud, etc.
  • Cloud and remote based service applications are prevalent. Such applications are hosted on public and private remote systems such as clouds and usually offer a set of web-based services for communicating back and forth with clients.
  • computers are intended to be used by direct user interaction with the computer.
  • computers have input hardware and software user interfaces to facilitate user interaction.
  • a modem general-purpose computer may include a keyboard, mouse, touchpad, camera, etc. for allowing a user to input data into the computer.
  • various software user interfaces may be available.
  • Disclosed embodiments may comprise or utilize a special purpose or general- purpose computer including computer hardware, as discussed in greater detail below. Disclosed embodiments also include physical and other computer-readable media for carrying or storing computer-executable instructions and/or data structures. Such computer-readable media can be any available media that can be accessed by a general purpose or special purpose computer system. Computer-readable media that store computer-executable instructions are physical storage media. Computer-readable media that carry computer-executable instructions are transmission media.
  • embodiments of the invention can comprise at least two distinctly different kinds of computer-readable media: physical computer-readable storage media and transmission computer-readable media.
  • Physical computer-readable storage media includes RAM, ROM, EEPROM, CD-ROM or other optical disk storage (such as CDs, DVDs, etc.), magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store desired program code means in the form of computer-executable instructions or data structures and which can be accessed by a general purpose or special purpose computer.
  • a “network” is defined as one or more data links that enable the transport of electronic data between computer systems and/or modules and/or other electronic devices.
  • Transmission media can include a network and/or data links which can be used to carry program code in the form of computer-executable instructions or data structures, and which can be accessed by a general purpose or special purpose computer. Combinations of the above are also included within the scope of computer-readable media.
  • program code means in the form of computer-executable instructions or data structures can be transferred automatically from transmission computer-readable media to physical computer-readable storage media (or vice versa).
  • program code means in the form of computer-executable instructions or data structures received over a network or data link can be buffered in RAM within a network interface module (e.g., a “NIC”), and then eventually transferred to computer system RAM and/or to less volatile computer-readable physical storage media at a computer system.
  • NIC network interface module
  • computer-readable physical storage media can be included in computer system components that also (or even primarily) utilize transmission media.
  • Computer-executable instructions comprise, for example, instructions and data which cause a general-purpose computer, special purpose computer, or special purpose processing device to perform a certain function or group of functions.
  • the computer- executable instructions may be, for example, binaries, intermediate format instructions such as assembly language, or even source code.
  • the invention may be practiced in network computing environments with many types of computer system configurations, including, personal computers, desktop computers, laptop computers, message processors, hand-held devices, multi-processor systems, microprocessor-based or programmable consumer electronics, network PCs, minicomputers, mainframe computers, mobile telephones, PDAs, pagers, routers, switches, and the like.
  • the invention may also be practiced in distributed system environments where local and remote computer systems, which are linked (either by hardwired data links, wireless data links, or by a combination of hardwired and wireless data links) through a network, both perform tasks.
  • program modules may be located in both local and remote memory storage devices.
  • the functionality described herein can be performed, at least in part, by one or more hardware logic components.
  • illustrative types of hardware logic components include Field-programmable Gate Arrays (FPGAs), Program-specific Integrated Circuits (ASICs), Program-specific Standard Products (ASSPs), System-on-a-chip systems (SOCs), Complex Programmable Logic Devices (CPLDs), etc.

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AU2021240036A AU2021240036A1 (en) 2020-03-20 2021-03-19 Signal conducting device for concurrent power and data transfer to and from un-wired sensors attached to a medical device
CN202180036656.7A CN115697471A (zh) 2020-03-20 2021-03-19 用于向和从附接到医疗装置的非有线传感器进行功率和数据的并发传送的信号传导装置
KR1020227036169A KR102868148B1 (ko) 2020-03-20 2021-03-19 의료 장비에 부착된 무선 센서로 및 이로부터 동시 발생하는 전력 및 데이터 전송을 위한 신호전송 장비
JP2022556648A JP7720318B2 (ja) 2020-03-20 2021-03-19 医療デバイスに取り付けられた無線センサとの同時電力およびデータ伝達のための信号伝導デバイス
EP21770508.6A EP4106862A4 (en) 2020-03-20 2021-03-19 SIGNAL CONDUCTION DEVICE FOR SIMULTANEOUS POWER AND DATA TRANSMISSION TO AND FROM WIRELESS SENSORS ATTACHED TO A MEDICAL DEVICE

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PCT/US2021/023198 Ceased WO2021188923A1 (en) 2020-03-20 2021-03-19 Catheter for imaging and measurement of pressure and other physiological parameters
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