Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
  • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/42—Details of probe positioning or probe attachment to the patient
  • A61B8/4245—Details of probe positioning or probe attachment to the patient involving determining the position of the probe, e.g. with respect to an external reference frame or to the patient
  • A61B8/4254—Details of probe positioning or probe attachment to the patient involving determining the position of the probe, e.g. with respect to an external reference frame or to the patient using sensors mounted on the probe
• • 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
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
• • 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
  • A61M25/0009—Making of catheters or other medical or surgical tubes
  • A61M25/0012—Making of catheters or other medical or surgical tubes with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• • 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
  • A61B1/313—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 for introducing through surgical openings, e.g. laparoscopes
  • A61B1/3137—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 for introducing through surgical openings, e.g. laparoscopes for examination of the interior of blood vessels
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00017—Electrical control of surgical instruments
  • A61B2017/00022—Sensing or detecting at the treatment site
  • A61B2017/00039—Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
  • A61B2017/00044—Sensing electrocardiography, i.e. ECG
  • A61B2017/00048—Spectral analysis
  • A61B2017/00053—Mapping
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00526—Methods of manufacturing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
  • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
  • A61B2034/2046—Tracking techniques
  • A61B2034/2051—Electromagnetic tracking systems
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
  • A61B2090/3954—Markers, e.g. radio-opaque or breast lesions markers magnetic, e.g. NMR or MRI
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
  • A61B2090/3983—Reference marker arrangements for use with image guided surgery
• • 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
  • A61B2562/0223—Magnetic field sensors

Definitions

• the present disclosure relates generally to catheters that are used in the human body.
• the present disclosure relates to an intravascular catheter that includes an integrated electronics package in its distal region, such as within its tip.
• catheters are used for an ever-growing number of procedures.
• catheters are used for diagnostic, therapeutic, and ablative procedures, to name just a few examples.
• the catheter is manipulated through the patient’s vasculature and to the intended site, for example, a site within the patient’s heart.
• an intravascular catheter including: a catheter shaft having a distal portion; a plurality of magnetic localization elements disposed within the distal portion of the catheter shaft; and an integrated electronics package disposed within the distal portion of the catheter shaft.
• the integrated electronics package includes: a power supply; a pre-amplifier; a multiplexor; and an imaging element driver.
• the integrated electronics package can be a system on a chip, such as an application specific integrated circuit.
• the plurality of magnetic localization elements can include a plurality of magnetic coils, which can be operably connected to the integrated electronics package.
• the plurality of magnetic localization elements can include a plurality of solid state magnetic localization elements, such as a plurality of anisotropic magnetoresistive sensors, and can be mounted within or on the integrated electronics package.
• a tip assembly for an intravascular catheter including: a shell; a plurality of magnetic localization elements disposed within the shell; and an integrated electronics package disposed within the shell.
• the integrated electronics package includes: a power supply; a pre-amplifier; a multiplexor, and an imaging element driver.
• the electronics package can include a system on a chip, such as an application specific integrated circuit.
• the plurality of magnetic localization elements can include a plurality of magnetic coils, which can be operably connected to the integrated electronics package.
• the plurality of magnetic localization elements can include a plurality of solid state magnetic localization elements, such as a plurality of anisotropic magnetoresistive sensors, which can be mounted within the integrated electronics package.
• the instant disclosure also provides a method of manufacturing a tip assembly for an intravascular catheter.
• the method includes: forming a shell; positioning an integrated electronics package within the shell; positioning a plurality of magnetic localization elements within the shell; and operably connecting the plurality of magnetic localization elements to the integrated electronics package.
• the integrated electronics package includes: a power supply; a pre-amplifier; a multiplexor; and an imaging element driver.
• the plurality of magnetic localization elements can be incorporated into the integrated electronics package.
• a plurality of solid state magnetic localization elements can be incorporated into the integrated electronics package.
• the integrated electronics package can include an application specific integrated circuit.
• Figure l is a perspective view of a representative catheter according to aspects of the instant disclosure.
• Figure 2 illustrates a first embodiment of a tip assembly for an intravascular catheter as disclosed herein.
• Figure 3 illustrates a second embodiment of a tip assembly for an intravascular catheter as disclosed herein.
• aspects of the instant disclosure relate to catheters with electronics packages integrated into their distal ends (e.g ., positioned within their distal tip assemblies).
• teachings herein can be applied to good advantage in connection with various types of catheters, including, but not limited to, intracardiac echocardiography (ICE) catheters.
• ICE intracardiac echocardiography
• the teachings herein can be applied in connection with intravascular catheters as disclosed in United States application no. 15/948,818 (“the ‘818 application”).
• the teachings herein can be applied in connection with catheters such as those disclosed in United States patent application publication no. 2014/0275957 (“the ‘957 publication”).
• the ‘818 application and the ‘957 publication are hereby incorporated by reference as though fully set forth herein.
• Figure 1 depicts a perspective view of a representative catheter 100, including a shaft 105 having a proximal portion 110 and a distal portion 190, which terminates in a tip 195.
• a representative catheter 100 including a shaft 105 having a proximal portion 110 and a distal portion 190, which terminates in a tip 195.
• the basic construction of catheter 100 will be familiar to those of ordinary skill in the art, the details thereof will be omitted herein, except to the extent relevant to an understanding of the instant disclosure.
• Figure 2 is a close-up view of distal portion 190, including tip 195, according to a first embodiment of the instant disclosure.
• a plurality of magnetic localization elements e.g., magnetic coils 200
• distal portion 190 which, for purposes of explanation, can also be referred to as a “shell”.
• Figure 2 depicts three orthogonal coils 200. As those of ordinary skill in the art will appreciate, these three orthogonal coils 200 allow tip 195 to be localized with six degrees of freedom within a magnetic localization field generated by an electroanatomical mapping system such as the EnSite PrecisionTM cardiac mapping system of Abbott Laboratories (Chicago, IL).
• integrated electronics package 210 is implemented as a system- on-a-chip (SoC), such as an application specific integrated circuit (ASIC) or a field programmable gate array (FPGA).
• SoC system- on-a-chip
• ASIC application specific integrated circuit
• FPGA field programmable gate array
• Integrated electronics package 210 includes a power supply, a pre-amplifier, a multiplexor, and electronics to drive imaging elements, such as transmitters and/or receivers.
• imaging elements themselves (e.g ., an ultrasonic transducer array, optical fibers, or the like) can also be included within integrated electronics package 210; alternatively, integrated electronics package 210 can include connections to imaging elements that are external to integrated electronics package 210.
• Coils 200 are operably connected to integrated electronics package 210, for example to pass power from integrated electronics package 210 to coils 200 and to pass electromagnetic signals (e.g., magnetic field measurements, control signals, and the like) between coils 200 and integrated electronics package 210.
• electromagnetic signals e.g., magnetic field measurements, control signals, and the like
• coils 200 can be made smaller than extant magnetic localization elements.
• extant coils 200 may be from about 0.5 cm to about 1 cm in length with diameters ranging from about 0.3 cm to about 0.5 cm.
• the proximity between coils 200 and integrated electronics package 210 according to the instant disclosure allows these dimensions to be reduced by about 50%.
• Additional cable connectors 220 are provided to connect integrated electronics package 210 (and thus coils 200) to a control unit. Although only one connector 220 is shown in the Figures, those of ordinary skill in the art will appreciate that multiple such connectors 220 can be used and/or bundled through shaft 105.
• coils 200 are replaced by one or more solid state magnetic localization elements 300, which can be mounted on or within integrated electronics package 210 (e.g, incorporated into the SoC or ASIC).
• solid state magnetic localization elements 300 may be anisotropic magnetoresistive (AMR) sensors, such as the AFF811 sensor from Sensitec GmbH (Lahnau, Germany).
• the proximity between the magnetic localization elements and integrated electronics package 210 advantageously improves the quality of signal communication therebetween (e.g ., it offers an improved signal -to-noise ratio relative to extant catheters).
• integrated electronics package 210 can also include elements that sense the orientation of shaft 105, such as one or more solid state accelerometers.
• All directional references e.g, upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise
• Joinder references e.g, attached, coupled, connected, and the like
• Joinder references are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Engineering & Computer Science (AREA)
• Surgery (AREA)
• Public Health (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Veterinary Medicine (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Biophysics (AREA)
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• Physics & Mathematics (AREA)
• Radiology & Medical Imaging (AREA)
• Pulmonology (AREA)
• Anesthesiology (AREA)
• Hematology (AREA)
• Robotics (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Ultra Sonic Daignosis Equipment (AREA)
• Media Introduction/Drainage Providing Device (AREA)
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• 2020
  • 2020-12-09 US US17/802,368 patent/US20230107872A1/en not_active Abandoned
  • 2020-12-09 JP JP2022554730A patent/JP2023516812A/ja active Pending
  • 2020-12-09 WO PCT/US2020/064036 patent/WO2021183196A1/en not_active Ceased
  • 2020-12-09 CN CN202080097966.5A patent/CN115209827A/zh active Pending
  • 2020-12-09 EP EP20838713.4A patent/EP4093313B1/en active Active
• 2024
  • 2024-04-18 JP JP2024067523A patent/JP2024102117A/ja active Pending

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