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WO2025046332A1 - Cadre d'ensemble dispositif d'interconnexion moulé implantable pour émetteur optique - Google Patents

Cadre d'ensemble dispositif d'interconnexion moulé implantable pour émetteur optique Download PDF

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Publication number
WO2025046332A1
WO2025046332A1 PCT/IB2024/056964 IB2024056964W WO2025046332A1 WO 2025046332 A1 WO2025046332 A1 WO 2025046332A1 IB 2024056964 W IB2024056964 W IB 2024056964W WO 2025046332 A1 WO2025046332 A1 WO 2025046332A1
Authority
WO
WIPO (PCT)
Prior art keywords
frame
optical emitter
pad
device assembly
medical device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IB2024/056964
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English (en)
Inventor
Mark R. Boone
Kenneth Heames
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Medtronic Inc
Original Assignee
Medtronic Inc
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Filing date
Publication date
Application filed by Medtronic Inc filed Critical Medtronic Inc
Publication of WO2025046332A1 publication Critical patent/WO2025046332A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • H—ELECTRICITY
    • H10—SEMICONDUCTOR DEVICES; ELECTRIC SOLID-STATE DEVICES NOT OTHERWISE PROVIDED FOR
    • H10H—INORGANIC LIGHT-EMITTING SEMICONDUCTOR DEVICES HAVING POTENTIAL BARRIERS
    • H10H20/00—Individual inorganic light-emitting semiconductor devices having potential barriers, e.g. light-emitting diodes [LED]
    • H10H20/80—Constructional details
    • H10H20/85—Packages
    • H10H20/8506—Containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0031—Implanted circuitry
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/026—Measuring blood flow
    • A61B5/0261—Measuring blood flow using optical means, e.g. infrared light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/07—Endoradiosondes
    • A61B5/076—Permanent implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/1459—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
    • H—ELECTRICITY
    • H10—SEMICONDUCTOR DEVICES; ELECTRIC SOLID-STATE DEVICES NOT OTHERWISE PROVIDED FOR
    • H10H—INORGANIC LIGHT-EMITTING SEMICONDUCTOR DEVICES HAVING POTENTIAL BARRIERS
    • H10H20/00—Individual inorganic light-emitting semiconductor devices having potential barriers, e.g. light-emitting diodes [LED]
    • H10H20/80—Constructional details
    • H10H20/85—Packages
    • H10H20/857—Interconnections, e.g. lead-frames, bond wires or solder balls
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
    • 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
    • A61B5/686—Permanently implanted devices, e.g. pacemakers, other stimulators, biochips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271—Specific aspects of physiological measurement analysis
    • A61B5/7275—Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271—Specific aspects of physiological measurement analysis
    • A61B5/7282—Event detection, e.g. detecting unique waveforms indicative of a medical condition
    • H—ELECTRICITY
    • H10—SEMICONDUCTOR DEVICES; ELECTRIC SOLID-STATE DEVICES NOT OTHERWISE PROVIDED FOR
    • H10H—INORGANIC LIGHT-EMITTING SEMICONDUCTOR DEVICES HAVING POTENTIAL BARRIERS
    • H10H20/00—Individual inorganic light-emitting semiconductor devices having potential barriers, e.g. light-emitting diodes [LED]
    • H10H20/80—Constructional details
    • H10H20/85—Packages
    • H10H20/855—Optical field-shaping means, e.g. lenses

Definitions

  • IMDs examples include heart monitors, blood pressure monitors, pacemakers, implantable cardiovascular defibrillators, myostimulators, neurological stimulators, drug delivery devices, insulin pumps, glucose monitors, tissue perfusion monitors, blood oxygen saturation (SpCh) monitors, tissue (skeletal muscle) oxygen saturation (StCL) monitors, and the like.
  • Monitoring such physiological parameters provides useful measures which can be utilized to manage therapies for treating a medical condition. For example, a decrease in blood oxygen saturation or in tissue perfusion may be associated with inadequate cardiac output or respiratory function.
  • monitoring allows an implantable medical device to respond to a decrease in oxygen saturation or tissue perfusion, for example, by delivering electrical stimulation therapy to the heart to restore a normal hemodynamic function.
  • the physical volume available to accommodate optical components is limited.
  • Commercially-available, off-the-shelf components may be too large and bulky for use in a practical IMD, and expensive customized approaches may be required.
  • many IMDs that use optical emitters require a so-called “deadbug” (reverse-mount) configuration where a light emission of the optical emitter and a set of solder leads for the optical emitter are both provided on a lower surface of the IMD.
  • Commercially-available dead-bug component frames can be much too large to integrate into a practical IMD.
  • commercially-available component frames may provide a large light emission angle, with some light exiting from the side of the frame.
  • This sideexiting light comes from the optical emitter when the emitter is operating.
  • the sideexiting light can reach an optical sensor of the IMD, causing a sensor output signal to exhibit a DC offset, and potentially swamping out or otherwise obscuring any useful signal that the sensor may be sensing.
  • the present disclosure describes devices and techniques for creating a molded interconnect device assembly frame for accommodating an optical emitter such as a lensed light-emitting diode (LED).
  • the frame provides a dead-bug mounting arrangement for the optical emitter, configured to provide a light emission of the optical emitter, as well as a set of solder leads for the optical emitter, on a lower surface of the assembly.
  • the frame provides a reverse-lead configuration for the optical emitter.
  • a frame formed according to the techniques of this disclosure may advantageously accommodate a commercial off-the-shelf (COTS) optical emitter while reducing or eliminating any light exiting the side of the frame, and providing a form factor suitable for use in an IMD.
  • COTS commercial off-the-shelf
  • an implantable medical device assembly comprises a frame configured to house an optical emitter for generating light, the frame comprising an upper surface, a lower surface, and at least one electrically-conductive path between a first pad on the lower surface and a second pad within the frame, wherein the second pad is configured for connection to an electrical terminal of the optical emitter, wherein the first pad is configured for soldering to a partially-metallized substrate with a transparent portion, to form an electrical connection between the lower surface and the substrate, and wherein the transparent portion is configured to pass at least a portion of the light generated by the optical emitter.
  • FIG. 1 is a block diagram of an illustrative implantable medical device (IMD) in accordance with one or more aspects of this disclosure.
  • IMD implantable medical device
  • FIG. 2 is a top view of an illustrative device assembly frame in accordance with one or more aspects of this disclosure.
  • FIG. 3 is a side sectional view of an illustrative device assembly frame along axis A-A of FIG. 2 in accordance with one or more aspects of this disclosure.
  • FIG. 4 is a side sectional view of an illustrative device assembly frame along axis B-B of FIG. 2 in accordance with one or more aspects of this disclosure.
  • FIG. 5 is a diagrammatic representation of an illustrative frame incorporating an optical emitter, and configured to perform one or more tissue measurements in accordance with one or more aspects of this disclosure.
  • FIG. 6 is a flowchart illustrating an example technique for forming a device assembly frame in accordance with one or more aspects of this disclosure.
  • FIG. 7 is a perspective drawing illustrating an example configuration for the IMD of FIG. 1.
  • FIG. 8 is a perspective drawing illustrating another example configuration for the IMD of FIG. 1.
  • the present disclosure describes devices and techniques for creating a molded interconnect device assembly frame for accommodating an optical emitter, such as a lensed light-emitting diode (LED).
  • the frame provides a dead-bug mounting arrangement for the optical emitter, configured to support a light emission of the optical emitter, as well as provide a set of solder leads for the optical emitter, on a lower surface of the frame.
  • a frame formed according to the techniques of this disclosure may advantageously accommodate a commercial off-the-shelf (COTS) optical emitter while reducing or eliminating any light exiting the side of the frame, and providing a form factor suitable for use in an IMD.
  • COTS commercial off-the-shelf
  • FIG. 1 is a block diagram of an illustrative implantable medical device (IMD) 100 in accordance with one or more aspects of this disclosure.
  • the IMD 100 includes a source 101 of light, such as an LED or a laser.
  • the source 101 may apply the light to a living tissue 105.
  • scattered light 109 can be produced.
  • the scattered light 109 may have a mean path 107, determined as an average of a plurality of scattered light paths of the scattered light 109.
  • At least a portion of the scattered light 109 may be incident upon an optical detector 103, such as a photocell.
  • the optical detector 103 can convert the incident light into a modulated electrical signal that can be used to determine one or more characteristics of the tissue 105.
  • these one or more characteristics may include a systolic blood pressure, a diastolic blood pressure, a glucose level, a blood oxygen saturation (SpCh) level, a tissue (skeletal muscle) oxygen saturation (StCL) level, a tissue impedance, and/or the like.
  • the distance between the source 101 and the detector 103 may be selected based on various consideration.
  • the form factor of the device 100 may impose certain extremes on this placement, e.g., between 0mm (immediately adjacent) and 10mm distance between the source 101 and the detector 103 (where the maximum length of the device 100 is 10mm).
  • the distance may be determined by the wavelengths used in the application. For example, an application using visible or infrared light might place the source 101 and the detector 103 between 3 -7mm apart.
  • More specific wavelength ranges may correlate to different distances- e.g., for green light, 0-3 mm may be used; for amber light, 3-4 mm may be used; and for infrared, 4-7mm may be used.
  • the desired depth of penetration of the mean path 107 may be considered in choosing the distance between the source 101 and the detector 103; for example, a distance of 6mm for certain wavelengths may yield a tissue depth of 3mm for the mean path 107.
  • Various other arrangements and distances the source 101 and the detector 103 will be apparent based on the particular application being implemented by the device 100.
  • FIG. 2 is a top view of an illustrative device assembly frame 104 for the light source 101 in accordance with one or more aspects of this disclosure.
  • a width of the frame 104 along axis A-A is in a range of about 1.5 to 3.0 millimeters
  • a length of the frame 104 along axis B-B is in a range of about 1.0 to 2.0 millimeters.
  • the width of the frame 104 along axis A-A is about 2.3 millimeters
  • the length of the frame 104 along axis B-B is about 1.5 millimeters.
  • a depth of the frame 104 is in a range of about 0.5 millimeters to 1.0 millimeters. In another further example, a depth of the frame 104 is about 0.7 millimeters.
  • the frame 104 is molded using plastic and/or epoxy, and one or more conductive paths are fabricated on the frame 104 using metallization. In an alternate example, the assembly frame 104 is configured to accommodate a light sensor.
  • a transparent, partially metallized substrate 110 can be configured to pass at least a portion of the light generated by the optical emitter.
  • the substrate 110 comprises a sapphire window.
  • the substrate 110 comprises a transparent material that can be metallized, such as glass, quartz, and/or a high-temperature plastic.
  • metallization may comprise thin film metal sputtering or plating.
  • the metallization can be applied to the substrate 110 by sputtering in a vacuum chamber to form a blanket metal layer. Then the blanket metal layer can be etched into a pattern to form an electrical interconnect similar to a printed wiring board, or an interconnect on an integrated circuit.
  • a metal can be plated over these conductor patterns to create very thick conductors for high- current applications.
  • the first pad 131 and the third pad 133 are optimized for best metal to mold adhesion and/or minimum solder joint thickness, wherein the frame 104 is fabricated using a molding process.
  • a maximum part thickness for the frame 104 and LED 108 mounted therein can be less than about 1.2 millimeters.
  • the frame 104 is fabricated of plastic and/or epoxy.
  • FIG. 4 is a side sectional view of an illustrative device assembly frame 104 along axis B-B of FIG. 2 in accordance with one or more aspects of this disclosure.
  • a cavity in a mold for the frame 104 may contain a small opening comprising the one or more tab gates 119, which allow hot plastic to enter the cavity before passing through and around the internal features of the mold until the mold is filled.
  • the frame 104 may include one or more tab gates 119 along one or more sides of the frame 104.
  • the one or more tab gates 119 each comprise a trapezoidal block milled into a parting line on an exterior surface of the frame 104.
  • FIG. 5 is a diagrammatic representation of an illustrative optical emitter 101 incorporating the frame 104 shown in FIGs. 3-4, and configured to perform one or more tissue measurements in accordance with one or more aspects of this disclosure.
  • the LED 108 generates light which travels through the transparent portion 110 and is incident upon a layer of living tissue 105 (FIG. 1). As the light travels through the tissue 105, scattered light may be produced. At least a portion of the scattered light 109 may be incident upon optical detector 103 (FIG. 1), such as a photocell.
  • the optical detector can convert the incident light into a modulated electrical signal that can be used to determine one or more characteristics of the tissue 105.
  • these one or more characteristics may include a systolic blood pressure, a diastolic blood pressure, a glucose level, a blood oxygen saturation (SpO2) level, a tissue (skeletal muscle) oxygen saturation (StO2) level, a tissue impedance, and/or the like.
  • FIG. 6 is a flowchart illustrating an example technique for forming a device assembly frame in accordance with one or more aspects of this disclosure.
  • a device assembly frame 104 (FIGs. 2-5) is molded, for example, using plastic and/or epoxy.
  • the frame 104 is configured to house the optical emitter 101.
  • the optical emitter 101 such as the LED 108, is configured for generating light.
  • the frame 104 includes the upper surface 123 (FIG. 3), the lower surface 125, the first electrically-conductive path 106 between the first pad 131 and the second pad 127, and the second electrically-conductive path 116 between the third pad 133 and the fourth pad 129.
  • the second pad 127 is configured for connection to the first electrical terminal 112 of the LED 108
  • the fourth pad 129 is configured for connection to the second electrical terminal 113 of the LED 108.
  • the lower surface 125 includes the transparent portion 110 configured to pass at least a portion of the light generated by the optical emitter 101.
  • the LED 108 (FIG. 3) is placed into the frame 104 such that a lens portion of the LED 108 faces in a downward direction towards the lower surface 125.
  • the first electrical terminal 112 contacts the second pad 127, and the second electrical terminal 113 contacts the fourth pad 129.
  • the first electrical terminal 112 is soldered to the second pad 127, and the second electrical terminal 113 is soldered to the fourth pad 129.
  • FIG. 7 is a perspective drawing illustrating an IMD 10A, which may be an example configuration of IMD 100 of FIG. 1.
  • IMD 10A may be embodied as a monitoring device having housing 612, proximal electrode 616A and distal electrode 616B.
  • Housing 612 may further comprise first major surface 614, second major surface 618, proximal end 620, and distal end 622.
  • Housing 612 encloses electronic circuitry located inside the IMD 10A and protects the circuitry contained therein from body fluids.
  • Housing 612 may be hermetically sealed and configured for subcutaneous implantation. Electrical feedthroughs provide electrical connection of electrodes 616A and 616B.
  • IMD 10A is defined by a length L, a width W and thickness or depth D and is in the form of an elongated rectangular prism wherein the length L is much larger than the width W, which in turn is larger than the depth D.
  • the geometry of the IMD 10A - in particular a width W greater than the depth D - is selected to allow IMD 10A to be inserted under the skin of the patient using a minimally invasive procedure and to remain in the desired orientation during insertion.
  • the device shown in FIG. 8 includes radial asymmetries (notably, the rectangular shape) along the longitudinal axis that maintains the device in the proper orientation following insertion.
  • the width W of major surface 614 may range from 3 mm to 15, mm, from 3 mm to 10 mm, or from 5 mm to 15 mm, and may be any single or range of widths between 3 mm and 15 mm.
  • the thickness of depth D of IMD 10A may range from 2 mm to 15 mm, from 2 mm to 9 mm, from 2 mm to 5 mm, from 5 mm to 15 mm, and may be any single or range of depths between 2 mm and 15 mm.
  • IMD 10A according to an example of the present disclosure is has a geometry and size designed for ease of implant and patient comfort. Examples of IMD 10A described in this disclosure may have a volume of three cubic centimeters (cm) or less, 1.5 cubic cm or less or any volume between three and 1.5 cubic centimeters.
  • Proximal electrode 616A is at or proximate to proximal end 620, and distal electrode 616B is at or proximate to distal end 622.
  • Proximal electrode 616A and distal electrode 616B are used to sense cardiac EGM signals, e.g., ECG signals, thoracically outside the ribcage, which may be sub-muscularly or subcutaneously.
  • Cardiac signals may be stored in a memory of IMD 10A, and data may be transmitted via integrated antenna 630A to another device, which may be another implantable device or an external device, such as external device 612.
  • proximal electrode 616A is located on first major surface 614 and is substantially flat, and outward facing.
  • proximal electrode 616A may utilize the three dimensional curved configuration of distal electrode 616B, providing a three dimensional proximal electrode (not shown in this example).
  • distal electrode 616B may utilize a substantially flat, outward facing electrode located on first major surface 614 similar to that shown with respect to proximal electrode 616A.
  • proximal electrode 616A and distal electrode 616B are located on both first major surface 614 and second major surface 618.
  • proximal electrode 616A and distal electrode 616B are located on both major surfaces 614 and 618.
  • both proximal electrode 616A and distal electrode 616B are located on one of the first major surface 614 or the second major surface 618 (e.g., proximal electrode 616A located on first major surface 614 while distal electrode 616B is located on second major surface 618).
  • IMD 10A may include electrodes on both major surface 614 and 618 at or near the proximal and distal ends of the device, such that a total of four electrodes are included on IMD 10A.
  • Electrodes 616A and 616B may be formed of a plurality of different types of biocompatible conductive material, e.g. stainless steel, titanium, platinum, iridium, or alloys thereof, and may utilize one or more coatings such as titanium nitride or fractal titanium nitride.
  • proximal end 620 includes a header assembly 628 that includes one or more of proximal electrode 616A, integrated antenna 630A, antimigration projections 632, and/or suture hole 634.
  • Integrated antenna 630A is located on the same major surface (i.e., first major surface 614) as proximal electrode 616A and is also included as part of header assembly 628.
  • Integrated antenna 630A allows IMD 10A to transmit and/or receive data.
  • integrated antenna 630A may be formed on the opposite major surface as proximal electrode 616A, or may be incorporated within the housing 612 of IMD 10A. In the example shown in FIG.
  • anti-migration projections 632 are located adjacent to integrated antenna 630A and protrude away from first major surface 614 to prevent longitudinal movement of the device.
  • anti-migration projections 632 include a plurality (e.g., nine) small bumps or protrusions extending away from first major surface 614.
  • anti-migration projections 632 may be located on the opposite major surface as proximal electrode 616A and/or integrated antenna 630A.
  • header assembly 628 includes suture hole 634, which provides another means of securing IMD 10A to the patient to prevent movement following insertion.
  • suture hole 634 is located adjacent to proximal electrode 616A.
  • header assembly 628 is a molded header assembly made from a polymeric or plastic material, which may be integrated or separable from the main portion of IMD 10A.
  • FIG. 8 is a perspective drawing illustrating another IMD 10B, which may be another example configuration of IMD 100 from FIG. 1.
  • IMD 10B of FIG. 8 may be configured substantially similarly to IMD 10A of FIG. 7, with differences between them discussed herein.
  • IMD 10B may include a leadless, subcutaneously-implantable monitoring device, e.g. an ICM.
  • IMD 10B includes housing having a base 640 and an insulative cover 642.
  • Proximal electrode 616C and distal electrode 616D may be formed or placed on an outer surface of cover 642.
  • Various circuitries and components of IMD 10B e.g., described above with respect to FIG. 1, may be formed or placed on an inner surface of cover 642, or within base 640.
  • Circuitries and components may be formed on the inner side of insulative cover 642, such as by using flip-chip technology.
  • Insulative cover 642 may be flipped onto a base 640. When flipped and placed onto base 640, the components of IMD 10B formed on the inner side of insulative cover 642 may be positioned in a gap 644 defined by base 640. Electrodes 616C and 616D and antenna 630B may be electrically connected to circuitry formed on the inner side of insulative cover 642 through one or more vias (not shown) formed through insulative cover 642.
  • Insulative cover 642 may be formed of sapphire (i.e., corundum), glass, parylene, and/or any other suitable insulating material.
  • Base 640 may be formed from titanium or any other suitable material (e.g., a biocompatible material). Electrodes 616C and 616D may be formed from any of stainless steel, titanium, platinum, iridium, or alloys thereof. In addition, electrodes 616C and 616D may be coated with a material such as titanium nitride or fractal titanium nitride, although other suitable materials and coatings for such electrodes may be used.
  • a material such as titanium nitride or fractal titanium nitride, although other suitable materials and coatings for such electrodes may be used.
  • the housing of IMD 10B defines a length L, a width W and thickness or depth D and is in the form of an elongated rectangular prism wherein the length L is much larger than the width W, which in turn is larger than the depth D, similar to IMD 10A of FIG. 7.
  • the spacing between proximal electrode 616C and distal electrode 616D may range from 5 mm to 50 mm, from 30 mm to 50 mm, from 35 mm to 45 mm, and may be any single spacing or range of spacings from 5 mm to 50 mm, such as approximately 40 mm.
  • IMD 10B may have a length L that ranges from 5 mm to about 70 mm.
  • the length L may range from 30 mm to 70 mm, 40 mm to 60 mm, 45 mm to 55 mm, and may be any single length or range of lengths from 5 mm to 50 mm, such as approximately 45 mm.
  • the width W may range from 3 mm to 15 mm, 5 mm to 15 mm, 5 mm to 10 mm, and may be any single width or range of widths from 3 mm to 15 mm, such as approximately 8 mm.
  • the thickness or depth D of IMD 10B may range from 2 mm to 15 mm, from 5 mm to 15 mm, or from 3 mm to 5 mm, and may be any single depth or range of depths between 2 mm and 15 mm, such as approximately 4 mm.
  • IMD 10B may have a volume of three cubic centimeters (cm) or less, or 1.5 cubic cm or less, such as approximately 1.4 cubic cm.
  • outer surface of cover 642 faces outward, toward the skin of the patient.
  • proximal end 646 and distal end 648 are rounded to reduce discomfort and irritation to surrounding tissue once inserted under the skin of the patient.
  • edges of IMD 10B may be rounded.
  • the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit.
  • Computer- readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).
  • ADD HERE Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry.
  • DSPs digital signal processors
  • ASICs application specific integrated circuits
  • FPGAs field programmable logic arrays
  • processors such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry.
  • DSPs digital signal processors
  • ASICs application specific integrated circuits
  • FPGAs field programmable logic arrays
  • this disclosure describes devices and techniques for creating a reverse- lead, molded interconnect device assembly frame for accommodating an optical emitter such as a lensed light-emitting diode (LED).
  • the device assembly frame provides a deadbug mounting arrangement for the optical emitter, configured to provide a light emission of the optical emitter, as well as a set of solder leads for the optical emitter, on a lower surface of the assembly.
  • a device assembly frame formed according to the techniques of this disclosure may advantageously accommodate a commercial off-the-shelf (COTS) optical emitter while reducing or eliminating any light exiting the side of the device assembly frame, and providing a form factor suitable for use in an IMD.
  • COTS commercial off-the-shelf
  • Example 1 An implantable medical device assembly comprising: a frame configured to house an optical emitter for generating light, the frame comprising an upper surface, a lower surface, and at least one electrically-conductive path between a first pad on the lower surface and a second pad within the frame, wherein the second pad is configured for connection to an electrical terminal of the optical emitter, wherein the first pad is configured for soldering to a partially-metallized substrate with a transparent portion, to form an electrical connection between the lower surface and the substrate, and wherein the transparent portion is configured to pass at least a portion of the light generated by the optical emitter.
  • Example 2 The implantable medical device assembly of Example 1, wherein the optical emitter comprises a light-emitting diode (LED).
  • LED light-emitting diode
  • Example 2 wherein the frame comprises an injection molded frame.
  • Example 4 The implantable medical device assembly of any of
  • Example 5 The implantable medical device assembly of any of Examples 1-4, wherein the optical emitter comprises an LED having an integrated lens.
  • Example 6 The implantable medical device assembly of any of Examples 1-5, wherein the LED has a width of 1.6 millimeters or less and a length of 0.8 millimeters or less.
  • Example 7 The implantable medical device assembly of any of
  • Examples 1-6 wherein the transparent portion comprises a sapphire window.
  • Example 8 The implantable medical device assembly of any of
  • Examples 1-7 wherein the transparent portion comprises a transparent material capable of being metallized.
  • Example 9 The implantable medical device assembly of any of Examples 1-8, wherein the frame is transfer molded with a dimensional precision of at least 50 micrometers.
  • Example 10 The implantable medical device assembly of Example 9, wherein the frame is transfer molded with a dimensional precision of plus or minus 20 micrometers.
  • Example 11 A method for manufacturing an implantable medical device assembly, the method comprising: molding a frame configured to house an optical emitter for generating light, the frame comprising an upper surface, a lower surface, and at least one electrically-conductive path between a first pad on the lower surface and a second pad within the frame, wherein the second pad is configured for connection to an electrical terminal of the optical emitter, wherein the first pad is configured for soldering to a partially-metallized substrate with a transparent portion, to form an electrical connection between the lower surface and the substrate, and wherein the substrate is configured to pass at least a portion of the light generated by the optical emitter.
  • Example 12 The method of Example 11, further comprising providing the optical emitter as a light-emitting diode (LED).
  • LED light-emitting diode
  • Example 13 The method of Example 11 or Example 12, further comprising injection molding the frame.

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Abstract

Un exemple d'ensemble dispositif médical implantable comprend un cadre configuré pour loger un émetteur optique pour générer de la lumière. Le cadre comprend une surface supérieure, une surface inférieure et au moins un trajet électroconducteur entre un premier tampon sur la surface inférieure et un second tampon à l'intérieur du cadre. Le second tampon est conçu pour être connecté à une borne électrique de l'émetteur optique, et le premier tampon est conçu pour être soudé à un substrat partiellement métallisé avec une partie transparente, la partie transparente étant conçue pour faire passer au moins une partie de la lumière générée par l'émetteur optique.
PCT/IB2024/056964 2023-09-01 2024-07-18 Cadre d'ensemble dispositif d'interconnexion moulé implantable pour émetteur optique Pending WO2025046332A1 (fr)

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US202363580141P 2023-09-01 2023-09-01
US63/580,141 2023-09-01

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8548543B2 (en) * 2010-10-29 2013-10-01 Medtronic, Inc. Symmetrically packaged optical sensors for implantable medical devices
US8634890B2 (en) * 2009-06-10 2014-01-21 Medtronic, Inc. Device and method for monitoring of absolute oxygen saturation and tissue hemoglobin concentration
US20140276928A1 (en) 2013-03-15 2014-09-18 Medtronic, Inc. Subcutaneous delivery tool
US20200135597A1 (en) * 2018-10-30 2020-04-30 Medtronic, Inc. Die carrier package and method of forming same

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8634890B2 (en) * 2009-06-10 2014-01-21 Medtronic, Inc. Device and method for monitoring of absolute oxygen saturation and tissue hemoglobin concentration
US8548543B2 (en) * 2010-10-29 2013-10-01 Medtronic, Inc. Symmetrically packaged optical sensors for implantable medical devices
US20140276928A1 (en) 2013-03-15 2014-09-18 Medtronic, Inc. Subcutaneous delivery tool
US20200135597A1 (en) * 2018-10-30 2020-04-30 Medtronic, Inc. Die carrier package and method of forming same

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