WO2003037399A2 - Hermetic component housing for photonic catheter - Google Patents

Hermetic component housing for photonic catheter Download PDF

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Publication number
WO2003037399A2
WO2003037399A2 PCT/US2002/034746 US0234746W WO03037399A2 WO 2003037399 A2 WO2003037399 A2 WO 2003037399A2 US 0234746 W US0234746 W US 0234746W WO 03037399 A2 WO03037399 A2 WO 03037399A2
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WO
WIPO (PCT)
Prior art keywords
housing
hermetic
housing body
fiber optic
distal end
Prior art date
Application number
PCT/US2002/034746
Other languages
French (fr)
Other versions
WO2003037399A3 (en
Inventor
Wilson Greatbatch
Michael L. Weiner
Original Assignee
Biophan Technologies, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biophan Technologies, Inc. filed Critical Biophan Technologies, Inc.
Priority to AU2002360326A priority Critical patent/AU2002360326A1/en
Publication of WO2003037399A2 publication Critical patent/WO2003037399A2/en
Publication of WO2003037399A3 publication Critical patent/WO2003037399A3/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056—Transvascular endocardial electrode systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056—Transvascular endocardial electrode systems
    • A61N1/0565—Electrode heads

Definitions

  • the present invention relates to photonic pacemakers and other photonic medical systems. More particularly, the invention concerns photonic catheter component housings and electrode systems designed for compatibility with MRI diagnostic apparatus.
  • the metallic cardiac electrodes and leads used in conventional cardiac stimulation and monitoring devices have always been a problem. They tend to fatigue, corrode, and break. Their physical properties (corrosion, strength, chemical activity, etc.) limit the materials which can be used to titanium, platinum metals, their alloys, to certain stainless steels, and to special structures to limit fatigue (such as spring coils, metal cladding, multiple strands, etc.) With respect to metallic leads, a leaky interface is often produced between the metal and the insulating sheath that surrounds the leads.
  • MRI compatible/safe pacemakers are disclosed for both implantable and wearable service.
  • the disclosed pacemakers feature photonic catheters carrying optical signals in lieu of metallic leads carrying electrical signals in order to avoid the dangers associated with MRI-generated electromagnetic fields.
  • Electro-optical and opto-electrical conversion systems are disposed at the proximal and distal ends of the photonic catheters to perform the necessary conversions between electrical and optical signaling modes.
  • the devices of the copending applications require component housings at the each end of the photonic catheter to house the conversion systems and other components. This not a problem at the proximal end because the main pacemaker enclosure is situated at that location.
  • a micro-miniature housing is required that is preferably no wider than the diameter of the photonic catheter, such that catheter insertion is not hampered.
  • the distal component housing must be hermetically sealed to protect the components therein from patient body fluids.
  • the foregoing problems are solved by a hermetic component carrying housing for use with a photonic catheter connected to a photonic pacemaker or other medical system designed for compatibility with Magnetic Resonance Imaging (MRI) procedures.
  • the hermetic housing includes a housing body having a proximal end and a distal end.
  • the body is formed with a hermetically sealed interior for carrying one or more electrical and/or optical components therein.
  • the proximal end of the body is adapted to mount to a distal end of a photonic catheter carrying a fiber optic element or bundle.
  • a hermetic terminal is provided to allow the fiber optic element or bundle to communicate with the body interior.
  • the body can be adapted to mount one or more electrodes designed for delivering or sensing electrical signals to body tissue, or it may be adapted to mount no electrodes.
  • the component housing may be implemented by itself at the distal end of the photonic catheter, or it may be used in conjunction with other housings of like or different construction.
  • a first aspect of the present invention is a hermetic housing for mounting to a distal end of a photonic catheter and adapted to house an optical component therein.
  • the hermetic housing includes a housing body having a proximal end and a distal end; a hermetically sealed interior in the housing body for enclosing the optical component therein, the proximal end of the housing body being adapted to mount to a distal end of a photonic catheter having a fiber optic element; and a hermetic terminal allowing the fiber optic element to communicate with the housing body interior.
  • a second aspect of the present invention is a hermetic component carrying housing in a photonic pacemaker.
  • the hermetic component carrying housing includes a housing body having a proximal end and a distal end; a hermetically sealed interior in the housing body enclosing an optical component therein, the proximal end of said housing body being mounted to a distal end of a photonic catheter carrying a fiber optic element; and a hermetic terminal allowing the fiber optic element to communicate with the housing body interior.
  • a third aspect of the present invention is a medical system.
  • the medical system includes a control unit adapted to generate body tissue stimulation signals; a photonic catheter having a proximal end in communication with the control unit and a fiber optic element for carrying optical stimulation signals, the catheter further having a distal end; and a hermetic housing.
  • the hermetic housing includes a housing body having a proximal end and a distal end, a hermetically sealed interior in the housing body enclosing an optical component therein, the proximal end of the housing body being mounted to the distal end of the photonic catheter, a hermetic terminal allowing the photonic catheter fiber optic element to communicate with the housing body interior, and means for delivering the stimulation signals to implanted body tissue.
  • a fourth aspect of the present invention is a medical system.
  • the medical system includes a control unit adapted to receive sensing signals representing one or more body function parameters; a photonic catheter having a proximal end in communication with the control unit and a fiber optic element for carrying optical sensing signals, the catheter further having a distal end; and a hermetic housing.
  • the hermetic housing includes a housing body having a proximal end and a distal end, a hermetically sealed interior in the housing body enclosing an optical component therein, the proximal end of the housing body being mounted to the distal end of the photonic catheter, a hermetic terminal allowing the photonic catheter fiber optic element to communicate with the housing body interior, and means for sensing body function parameters and generating the sensing signals.
  • a fifth aspect of the present invention is a photonic catheter unit adapted for use with a medical system.
  • the photonic catheter unit includes a hermetic component carrying housing; a fiber optic element for carrying optical stimulation signals between a control unit located at a proximal end of fiber optic element and the hermetic component carrying housing located at a distal end of said fiber optic element; and a biocompatible sheath covering the fiber optic element.
  • the hermetic component carrying housing includes a housing body having a proximal end and a distal end, a hermetically sealed interior in the housing body enclosing an optical component therein, the proximal end of the housing body being mounted to the distal end of fiber optic element, a he ⁇ netic terminal allowing the photonic catheter fiber optic element to communicate with the housing body interior, and means for delivering the stimulation signals to implanted body tissue.
  • a sixth aspect of the present invention is a photonic catheter unit adapted for use with a medical system.
  • the photonic catheter unit includes a hermetic component carrying housing; a fiber optic element for carrying optical sensing signals between a control unit located at a proximal end of fiber optic element and the hermetic component carrying housing located at a distal end of the fiber optic element; and a biocompatible sheath covering the fiber optic element.
  • the he ⁇ netic component carrying housing includes a housing body having a proximal end and a distal end, a hermetically sealed interior in the housing body enclosing an optical component therein, the proximal end of the housing body being mounted to the distal end of fiber optic element, a hermetic terminal allowing the photonic catheter fiber optic element to communicate with the housing body interior, and means for sensing one or more body function parameters and generating the sensing signals.
  • Figure 1 is an exploded perspective view of a hermetic component housing constructed in accordance with one embodiment of the present invention
  • Figures 2A, 2B and 2C are sectional axial centerline views showing alternative ways in which the component housing of Figure 1 can be configured to provide photonic pacemaker electrode terminations;
  • Figure 3 is a perspective view of the component housing of Figure 1 showing details of exemplary components that may be housed therein;
  • FIG. 4 is a partially exploded perspective view of a hermetic component housing constructed in accordance with another embodiment of the present invention.
  • Figures 5A and 5B are sectional axial centerline views showing alternative ways in which the component housing of Figure 4 can be configured to provide photonic pacemaker electrode terminations;
  • Figure 6 is a perspective view of the component housing of Figure 4 showing details of exemplary components that may be housed therein;
  • Figure 7 is a partially exploded perspective view of a hermetic component housing constructed in accordance with another embodiment of the present invention
  • Figure 8 is a sectional view taken along the axial centerline of the component housing of Figure 7;
  • Figure 9 is a perspective view of the component housing of Figure 7 showing details of exemplary components that may be housed therein;
  • Figure 10 is a diagrammatic view of an implantable pacemaker comprising a he ⁇ netic housing in accordance with the invention.
  • Figure 11 is a diagrammatic view of a wearable pacemaker comprising a hermetic housing in accordance with the invention.
  • the electrode termination pair 2 includes a cup-shaped structure (tip) 4 acting as a tip electrode and the hermetic housing 6 (ring) acting as a ring electrode.
  • the tip 4 and the ring 6 are both substantially cylindrical in shape, and preferably have the same wall thickness.
  • the tip 4 has a rounded nose portion and a base portion that is planar in cross-section.
  • the ring 6 has proximal and distal end portions that are both preferably planar in cross section.
  • the tip 4 and the ring 6 can be made from a biocompatible, non-ferromagnetic metal such platinum, titanium or alloy of platinum or titanium.
  • the tip 4 and the ring 6 can be made of a non-metallic material, such as ceramic, and covered with electrically conductive coatings 8 and 10, respectively.
  • the difference between Figures 2B and 2C is that all exposed surfaces of the tip 4 and the ring 6 are coated in Figure 2B, whereas only the outer surface of the tip and ring are coated in Figure 2C.
  • the material used is preferably a suitable biocompatible ceramic material such a ceramic of the type commonly used for joint prostheses.
  • a ceramic slurry can be formed into the desired shapes and fired to bake the ceramic material.
  • the electrically conductive coatings 8 and 10 are preferably formed by very thinly coating the tip 4 and the ring 6, as by electroplating, sputtering or other deposition technique, etc., with a suitable metal.
  • the metal preferably has low magnetic susceptibility, such as titanium, platinum, an alloy of titanium or platinum, or the like.
  • the coatings 8 and 10 are applied as thin as possible to achieve the twin goals of efficient electrical interaction with implanted tissue while minimizing interaction with MRI induced electromagnetic fields.
  • the thickness of the coatings 8 and 10 may range from mono-molecular thickness to sub-micron or micron level thickness.
  • Figures 1, 2 A, 2B and 2C show the electrode termination pair 2 of Figure 1 being mounted to the distal end of a photonic catheter 12 of the type disclosed in the co-pending applications referenced above.
  • the tip 4 and the ring 6 are also interconnected by a short insulative stub 14 that is solid, generally cylindrical in shape, and made from silicone, polyurethane, polyethylene, or any other suitable biocompatible electrically insulating material.
  • the outside diameter of the stub 14 preferably equals the outside diameter of the tip 4 and the ring 6, to facilitate efficient implantation and removal in a patient.
  • the ends of the stub 14 can be bonded to the tip 4 and the ring 6 using a suitable medical adhesive.
  • the stub 14 can be formed with end portions 16 of reduced diameter. One end portion 16 of the stub 14 is received into an opening 18 in the base portion of the tip 4 and bonded therein. The other end portion 16 of the stub 14 is received into an opening 20 in the distal end of the ring 6 and bonded therein.
  • the completed tip/ring assembly can be mounted to the distal end of the photonic catheter 12 in similar fashion, h particular, the photonic catheter 12 will be a generally cylindrical element whose exterior sheath 21 is made from silicone, polyurethane, polyethylene, or any other suitable biocompatible electrically insulating material.
  • the sheath 21 could be tubular in shape, with a small center bore carrying one or more optical conductors therein.
  • the sheath 21 could be fomied around the optical conductors such that the conductors are embedded in the material of the sheath.
  • the outside diameter of the sheath 21 will preferably be the same as that of the ring 6 and can be bonded thereto using a suitable medical adhesive.
  • the sheath 21 may be formed with a small end portion 22 of reduced diameter that is snugly received within an opening 23 in the proximal end the ring 6 and bonded therein. Because the ring 6 functions as a hermetically sealed component housing, it must be provided with hermetically sealed closures at or near the ends thereof. These closures may be provided by a pair of closure walls 24 and 26 that are secured within the interior of the ring 6.
  • the closure walls 24 and 26 can be formed from any suitable biocompatible material capable of sealing the ring interior, including metals, polymers, and potentially other materials.
  • the inside of the ring 6 can be formed with a pair of recessed annular shoulders 27.
  • a component array by reference numeral 28, and may include opto-electrical transducers, electro-optical transducers, signal processors and amplifiers, digital microprocessors, temperature sensors, R-wave sensors, partial oxygen sensors, and any number of other components.
  • a positive teraiinal of the component array 28 is connected to a short metallic lead 30 made from copper or other suitable material of low magnetic susceptance.
  • the lead 30 is electrically connected to the ring 6 by attaching it, as by soldering or the like, directly to the ring itself
  • the metallic lead 30 is electrically connected to the ring 6 by attaching it, as by soldering or the like, to an interior portion of the metallic coating 10.
  • the metallic lead 30 is fed through a small hole 31 in the wall of the ring 6 so that it may be attached to the exterior metallic coating 10, as by soldering or the like.
  • a negative terminal of the component array 28 connects to a longer metallic lead 32 that is also made from copper or other suitable material of low magnetic susceptance. This metallic lead 32 feeds through a hermetic seal terminal 34 mounted on the closure wall 24.
  • the metallic lead is electrically attached, as by soldering or the like, directly to the tip itself.
  • the metallic lead 32 is electrically attached, as by soldering or the like, to an interior portion of the metallic coating 8.
  • the metallic lead 32 is fed through a small hole 35 in the ceramic wall of the tip 4 so that it may be attached to the metallic coating 8, as by soldering or the like.
  • the tip 4 and the ring 6 When the tip 4 and the ring 6 are implanted in a patient's heart, the tip 4 will typically be embedded in the endocardial tissue, while the ring 6 is situated in the right ventricle, in electrical contact with the endocardium via the ventricular blood.
  • an optical pulse emanating from a photonic pacemaker pulsing unit (not shown) is sent down a fiber optic element or bundle 36 of the photonic catheter 12.
  • the fiber optic element or bundle 36 passes into the hermetically sealed interior of the ring 6 via a hermetic seal terminal 38. There, the fiber optic element or bundle 36 delivers the optical pulse to the component array 28, which preferably includes a photodiode array.
  • the photodiode array produces an electrical impulse that negatively drive the tip 4 with respect to the ring 6 at a potential of about 3-4 volts and a current level of about 3 milliamperes for a total power output of about 10 milliwatts.
  • a sensing function could be added by incorporating an electro-optical transducer into the component array 28. Electrical sense signals would then be converted to optical signals and placed on the fiber optic element or bundle 36 for delivery to a sensing unit (not shown).
  • Figure 3 illustrates an exemplary construction of the component array 28 in which the array comprises a photodiode array 28a for receiving optical pacing signals from the fiber optic element or bundle 36 and a light emitting diode 28b for delivering optical sensing signals to the fiber optic element or bundle 36.
  • the components 28a and 28b are mounted on a circuit substrate 28c that is electrically connected to an electrical circuit unit 28d, that may include amplifiers, oscillators, a microprocessor and other devices that can assist electrical pulse delivery and biological sensing functions.
  • an electrical circuit unit 28d that may include amplifiers, oscillators, a microprocessor and other devices that can assist electrical pulse delivery and biological sensing functions.
  • FIG 4 another embodiment of the invention is shown in which a modified hermetic housing provides a complete electrode termination pair 142.
  • the electrode termination pair 142 includes a tip 144 and a ring 146 that are constructed as metallic coatings formed on the hermetic housing, which is designated by reference numeral 148.
  • An electrically conductive coating 150 formed at the distal end of the housing 148 provides the tip 144.
  • An electrically conductive coating 152 formed at the proximal end of the housing 148 provides the ring 146.
  • Figures 5A and 5B show that both the inside and the outside surfaces of the housing 148 are coated in Figure 5A, whereas only the outer surface of the housing 148 is coated in Figure 5B.
  • Figures 5A and 5B also show that the component array 28 of Figures 1-3 can be hermetically sealed within the housing 148 via the hermetic seal 26. The proximal end of the housing 148 may then be secured to the distal end of the photonic catheter 12, and the fiber optic element or array 36 can be connected to the component array 28 via the hermetic terminal 38.
  • the component a ⁇ ay 28 is electrically connected to the tip 144 and the ring 146 via the electrical leads 32 and 30, respectively.
  • FIG. 6 shows an exemplary implementation of the component array 28 within the housing 148.
  • This component array configuration is identical to the component array configuration of Figure 4, and the description thereof will not be repeated here.
  • FIG 7 another embodiment of the invention is shown in which a modified hermetic housing again provides a complete electrode termination pair 242.
  • the electrode termination pair 242 includes a tip electrode 244 and a ring electrode 246 that are constructed as electrically conductive band coatings on the hermetic housing, which is designated by reference numeral 248.
  • a shallow well 250 formed near the distal end of the housing 248 may be used to mount the tip 244.
  • a shallow well 252 formed toward the proximal end of the housing 248 may be used to mount the ring 246.
  • Figure 8 also shows that the component array 28 of Figures 1-3 can be hermetically sealed within the housing 248 via the hermetic seal 26.
  • the proximal end of the housing 248 may then be secured to the distal end of the photonic catheter 12, and the fiber optic element or array 36 can be connected to the component array 28 via the hermetic terminal 38.
  • the component array 28 is electrically connected to the tip 244 and the ring 246 via the electrical leads 32 and 30, respectively.
  • the lead 32 feeds through a small hole 254 formed in the housing 248 in order to reach the tip 244.
  • the lead 30 feeds through a small hole 256 formed in the housing 248 in order to reach the ring 246.
  • Figure 9 shows an exemplary implementation of the component a ⁇ ay 28 within the housing 248. This component array configuration is identical to the component array configuration of Figure 4, and the description thereof will not be repeated here.
  • the pacemaker 302 includes a first (main) enclosure 304 that is connected to the proximal end 306 of a photonic catheter 308.
  • a distal end 310 of the photonic catheter 308 mounts a hemietic housing 312 constructed in accordance with a suitable one of the embodiments disclosed herein.
  • the housing 312 can form all or part of a tip/ring electrode termination pair 314, and will house a component array 28 containing suitable electrical and optical components to perform whatever pacing and/or sensing functions are required.
  • the pacemaker 402 includes a first (main) enclosure 404 that is connected to the proximal end 406 of a photonic catheter 408.
  • a distal end 410 of the photonic catheter 408 mounts a hermetic housing 412 constructed in accordance with a suitable one of the embodiments disclosed herein.
  • the housing 412 can form all or part of a tip/ring electrode teraiination pair 414, and will house a component array 28 containing suitable electrical and optical components to perform whatever pacing and/or sensing functions are required.
  • hermetic housings are shown being attached to the distal end of a photonic catheter, a chain of several hermetic housings can be used, each containing one or more electrical and/or optical components for performing one or more biologically useful functions relative to an implanted patient.
  • the hermetic housings are shown to be adapted to mount, or to function as, an electrode or an electrode pair, the housings could be implemented without electrodes thereon in device implementations where there are other structures that mount, or function as, electrodes.

Abstract

A wearable pacemaker (402 of Figure 11) includes a main enclosure (404 of Figure 11) that is connected to a proximal end (406 of Figure 11) of a photonic catheter (408 of Figure 11). A distal end (410 of Figure 11) of the photonic catheter (408 of Figure 11) mounts a hermetic housing (412 of Figure 11). The hermetic housing (412 of Figure 11) can form all or part of a tip/ring electrode termination pair (414 of Figure 11), and will house a component array (28 of Figure 11) containing suitable electrical and optical components to perform whatever pacing and/or sensing functions are required.

Description

HERMETIC COMPONENT HOUSING FOR PHOTONIC
CATHETER
FIELD OF THE PRESENT INVENTION
The present invention relates to photonic pacemakers and other photonic medical systems. More particularly, the invention concerns photonic catheter component housings and electrode systems designed for compatibility with MRI diagnostic apparatus.
BACKGROUND OF THE PRESENT INVENTION The metallic cardiac electrodes and leads used in conventional cardiac stimulation and monitoring devices have always been a problem. They tend to fatigue, corrode, and break. Their physical properties (corrosion, strength, chemical activity, etc.) limit the materials which can be used to titanium, platinum metals, their alloys, to certain stainless steels, and to special structures to limit fatigue (such as spring coils, metal cladding, multiple strands, etc.) With respect to metallic leads, a leaky interface is often produced between the metal and the insulating sheath that surrounds the leads.
The problem of metallic leads has been addressed by applicants' assignee in an effort to provide a pacemaker that is compatible with MRI diagnostic imaging procedures. See copending serial nos. 09/864,944 and 09,865,049, both filed on May
24, 2001, and copending serial nos. 09/885,867 and 09/885,868, both filed on June 20, 2001. In these copending patent applications, the contents of which are fully incorporated herein by this reference, MRI compatible/safe pacemakers are disclosed for both implantable and wearable service. The disclosed pacemakers feature photonic catheters carrying optical signals in lieu of metallic leads carrying electrical signals in order to avoid the dangers associated with MRI-generated electromagnetic fields. Electro-optical and opto-electrical conversion systems are disposed at the proximal and distal ends of the photonic catheters to perform the necessary conversions between electrical and optical signaling modes.
The devices of the copending applications require component housings at the each end of the photonic catheter to house the conversion systems and other components. This not a problem at the proximal end because the main pacemaker enclosure is situated at that location. At the distal end, a micro-miniature housing is required that is preferably no wider than the diameter of the photonic catheter, such that catheter insertion is not hampered. In addition to being small in size, the distal component housing must be hermetically sealed to protect the components therein from patient body fluids. Moreover, it should preferably carry at least one of the electrodes used for cardiac stimulation and/or sensing. It is thus purpose and goal of the present invention to address alternative designs for hermetic component housings designed for implantable service at the distal end of a photonic catheter in a photonic pacemaker system.
The foregoing problems are solved by a hermetic component carrying housing for use with a photonic catheter connected to a photonic pacemaker or other medical system designed for compatibility with Magnetic Resonance Imaging (MRI) procedures. The hermetic housing includes a housing body having a proximal end and a distal end. The body is formed with a hermetically sealed interior for carrying one or more electrical and/or optical components therein. The proximal end of the body is adapted to mount to a distal end of a photonic catheter carrying a fiber optic element or bundle. A hermetic terminal is provided to allow the fiber optic element or bundle to communicate with the body interior. The body can be adapted to mount one or more electrodes designed for delivering or sensing electrical signals to body tissue, or it may be adapted to mount no electrodes. The component housing may be implemented by itself at the distal end of the photonic catheter, or it may be used in conjunction with other housings of like or different construction.
SUMMARY OF THE PRESENT INVENTION A first aspect of the present invention is a hermetic housing for mounting to a distal end of a photonic catheter and adapted to house an optical component therein. The hermetic housing includes a housing body having a proximal end and a distal end; a hermetically sealed interior in the housing body for enclosing the optical component therein, the proximal end of the housing body being adapted to mount to a distal end of a photonic catheter having a fiber optic element; and a hermetic terminal allowing the fiber optic element to communicate with the housing body interior.
A second aspect of the present invention is a hermetic component carrying housing in a photonic pacemaker. The hermetic component carrying housing includes a housing body having a proximal end and a distal end; a hermetically sealed interior in the housing body enclosing an optical component therein, the proximal end of said housing body being mounted to a distal end of a photonic catheter carrying a fiber optic element; and a hermetic terminal allowing the fiber optic element to communicate with the housing body interior. A third aspect of the present invention is a medical system. The medical system includes a control unit adapted to generate body tissue stimulation signals; a photonic catheter having a proximal end in communication with the control unit and a fiber optic element for carrying optical stimulation signals, the catheter further having a distal end; and a hermetic housing. The hermetic housing includes a housing body having a proximal end and a distal end, a hermetically sealed interior in the housing body enclosing an optical component therein, the proximal end of the housing body being mounted to the distal end of the photonic catheter, a hermetic terminal allowing the photonic catheter fiber optic element to communicate with the housing body interior, and means for delivering the stimulation signals to implanted body tissue. A fourth aspect of the present invention is a medical system. The medical system includes a control unit adapted to receive sensing signals representing one or more body function parameters; a photonic catheter having a proximal end in communication with the control unit and a fiber optic element for carrying optical sensing signals, the catheter further having a distal end; and a hermetic housing. The hermetic housing includes a housing body having a proximal end and a distal end, a hermetically sealed interior in the housing body enclosing an optical component therein, the proximal end of the housing body being mounted to the distal end of the photonic catheter, a hermetic terminal allowing the photonic catheter fiber optic element to communicate with the housing body interior, and means for sensing body function parameters and generating the sensing signals.
A fifth aspect of the present invention is a photonic catheter unit adapted for use with a medical system. The photonic catheter unit includes a hermetic component carrying housing; a fiber optic element for carrying optical stimulation signals between a control unit located at a proximal end of fiber optic element and the hermetic component carrying housing located at a distal end of said fiber optic element; and a biocompatible sheath covering the fiber optic element. The hermetic component carrying housing includes a housing body having a proximal end and a distal end, a hermetically sealed interior in the housing body enclosing an optical component therein, the proximal end of the housing body being mounted to the distal end of fiber optic element, a heπnetic terminal allowing the photonic catheter fiber optic element to communicate with the housing body interior, and means for delivering the stimulation signals to implanted body tissue. A sixth aspect of the present invention is a photonic catheter unit adapted for use with a medical system. The photonic catheter unit includes a hermetic component carrying housing; a fiber optic element for carrying optical sensing signals between a control unit located at a proximal end of fiber optic element and the hermetic component carrying housing located at a distal end of the fiber optic element; and a biocompatible sheath covering the fiber optic element. The heπnetic component carrying housing includes a housing body having a proximal end and a distal end, a hermetically sealed interior in the housing body enclosing an optical component therein, the proximal end of the housing body being mounted to the distal end of fiber optic element, a hermetic terminal allowing the photonic catheter fiber optic element to communicate with the housing body interior, and means for sensing one or more body function parameters and generating the sensing signals.
BRIEF DESCRIPTION OF THE DRAWINGS
The foregoing and other features and advantages of the invention will be apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying Drawing in which:
Figure 1 is an exploded perspective view of a hermetic component housing constructed in accordance with one embodiment of the present invention; Figures 2A, 2B and 2C are sectional axial centerline views showing alternative ways in which the component housing of Figure 1 can be configured to provide photonic pacemaker electrode terminations;
Figure 3 is a perspective view of the component housing of Figure 1 showing details of exemplary components that may be housed therein;
Figure 4 is a partially exploded perspective view of a hermetic component housing constructed in accordance with another embodiment of the present invention;
Figures 5A and 5B are sectional axial centerline views showing alternative ways in which the component housing of Figure 4 can be configured to provide photonic pacemaker electrode terminations;
Figure 6 is a perspective view of the component housing of Figure 4 showing details of exemplary components that may be housed therein;
Figure 7 is a partially exploded perspective view of a hermetic component housing constructed in accordance with another embodiment of the present invention; Figure 8 is a sectional view taken along the axial centerline of the component housing of Figure 7;
Figure 9 is a perspective view of the component housing of Figure 7 showing details of exemplary components that may be housed therein;
Figure 10 is a diagrammatic view of an implantable pacemaker comprising a heπnetic housing in accordance with the invention; and
Figure 11 is a diagrammatic view of a wearable pacemaker comprising a hermetic housing in accordance with the invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE PRESENT INVENTION
Turning now to Figure 1, a first embodiment of the invention is shown in which a hermetic housing is constructed to provide part of an electrode termination pair 2. The electrode termination pair 2 includes a cup-shaped structure (tip) 4 acting as a tip electrode and the hermetic housing 6 (ring) acting as a ring electrode. The tip 4 and the ring 6 are both substantially cylindrical in shape, and preferably have the same wall thickness. Note that the tip 4 has a rounded nose portion and a base portion that is planar in cross-section. The ring 6 has proximal and distal end portions that are both preferably planar in cross section. As shown in Figure 2A, the tip 4 and the ring 6 can be made from a biocompatible, non-ferromagnetic metal such platinum, titanium or alloy of platinum or titanium. As shown in Figures 2B and 2C, the tip 4 and the ring 6 can be made of a non-metallic material, such as ceramic, and covered with electrically conductive coatings 8 and 10, respectively. The difference between Figures 2B and 2C is that all exposed surfaces of the tip 4 and the ring 6 are coated in Figure 2B, whereas only the outer surface of the tip and ring are coated in Figure 2C.
If a ceramic is used to form the tip 4 and the ring 6, the material used is preferably a suitable biocompatible ceramic material such a ceramic of the type commonly used for joint prostheses. By way of example only, such material is available from Ceramic Components Inc. of Latrobe, PA. To form a ceramic tip and ring, a ceramic slurry can be formed into the desired shapes and fired to bake the ceramic material.
The electrically conductive coatings 8 and 10 are preferably formed by very thinly coating the tip 4 and the ring 6, as by electroplating, sputtering or other deposition technique, etc., with a suitable metal. To facilitate MRI compatibility, the metal preferably has low magnetic susceptibility, such as titanium, platinum, an alloy of titanium or platinum, or the like. Preferably, the coatings 8 and 10 are applied as thin as possible to achieve the twin goals of efficient electrical interaction with implanted tissue while minimizing interaction with MRI induced electromagnetic fields. By way of example, the thickness of the coatings 8 and 10 may range from mono-molecular thickness to sub-micron or micron level thickness.
Figures 1, 2 A, 2B and 2C show the electrode termination pair 2 of Figure 1 being mounted to the distal end of a photonic catheter 12 of the type disclosed in the co-pending applications referenced above. The tip 4 and the ring 6 are also interconnected by a short insulative stub 14 that is solid, generally cylindrical in shape, and made from silicone, polyurethane, polyethylene, or any other suitable biocompatible electrically insulating material. The outside diameter of the stub 14 preferably equals the outside diameter of the tip 4 and the ring 6, to facilitate efficient implantation and removal in a patient. The ends of the stub 14 can be bonded to the tip 4 and the ring 6 using a suitable medical adhesive. To provide additional connection integrity, the stub 14 can be formed with end portions 16 of reduced diameter. One end portion 16 of the stub 14 is received into an opening 18 in the base portion of the tip 4 and bonded therein. The other end portion 16 of the stub 14 is received into an opening 20 in the distal end of the ring 6 and bonded therein.
The completed tip/ring assembly can be mounted to the distal end of the photonic catheter 12 in similar fashion, h particular, the photonic catheter 12 will be a generally cylindrical element whose exterior sheath 21 is made from silicone, polyurethane, polyethylene, or any other suitable biocompatible electrically insulating material. Note that the sheath 21 could be tubular in shape, with a small center bore carrying one or more optical conductors therein. Alternatively, the sheath 21 could be fomied around the optical conductors such that the conductors are embedded in the material of the sheath. In either case, the outside diameter of the sheath 21 will preferably be the same as that of the ring 6 and can be bonded thereto using a suitable medical adhesive. To provide additional connection integrity, the sheath 21 may be formed with a small end portion 22 of reduced diameter that is snugly received within an opening 23 in the proximal end the ring 6 and bonded therein. Because the ring 6 functions as a hermetically sealed component housing, it must be provided with hermetically sealed closures at or near the ends thereof. These closures may be provided by a pair of closure walls 24 and 26 that are secured within the interior of the ring 6. The closure walls 24 and 26 can be formed from any suitable biocompatible material capable of sealing the ring interior, including metals, polymers, and potentially other materials. To facilitate the secure hermetic attachment of the closure walls 24 and 26, the inside of the ring 6 can be formed with a pair of recessed annular shoulders 27.
There may be disposed within the ring 6 any number of components for delivering electrical signals to, or sensing biological activity in, a body. Such components are collectively shown as a component array by reference numeral 28, and may include opto-electrical transducers, electro-optical transducers, signal processors and amplifiers, digital microprocessors, temperature sensors, R-wave sensors, partial oxygen sensors, and any number of other components. To provide electrical interaction with surrounding body tissue, a positive teraiinal of the component array 28 is connected to a short metallic lead 30 made from copper or other suitable material of low magnetic susceptance.
In Figure 2A, the lead 30 is electrically connected to the ring 6 by attaching it, as by soldering or the like, directly to the ring itself, h Figure 2B, the metallic lead 30 is electrically connected to the ring 6 by attaching it, as by soldering or the like, to an interior portion of the metallic coating 10. h Figure 2B, the metallic lead 30 is fed through a small hole 31 in the wall of the ring 6 so that it may be attached to the exterior metallic coating 10, as by soldering or the like. A negative terminal of the component array 28 connects to a longer metallic lead 32 that is also made from copper or other suitable material of low magnetic susceptance. This metallic lead 32 feeds through a hermetic seal terminal 34 mounted on the closure wall 24. It then extends through the material of the stub 14 (which can be molded around the lead 32) and into the tip 4. hi Figure 2 A, the metallic lead is electrically attached, as by soldering or the like, directly to the tip itself. In Figure 2B, the metallic lead 32 is electrically attached, as by soldering or the like, to an interior portion of the metallic coating 8. In Figure 2C, the metallic lead 32 is fed through a small hole 35 in the ceramic wall of the tip 4 so that it may be attached to the metallic coating 8, as by soldering or the like. When the tip 4 and the ring 6 are implanted in a patient's heart, the tip 4 will typically be embedded in the endocardial tissue, while the ring 6 is situated in the right ventricle, in electrical contact with the endocardium via the ventricular blood. If the photonic catheter 12 is connected to a pacemaker, an optical pulse emanating from a photonic pacemaker pulsing unit (not shown) is sent down a fiber optic element or bundle 36 of the photonic catheter 12. The fiber optic element or bundle 36 passes into the hermetically sealed interior of the ring 6 via a hermetic seal terminal 38. There, the fiber optic element or bundle 36 delivers the optical pulse to the component array 28, which preferably includes a photodiode array. The photodiode array produces an electrical impulse that negatively drive the tip 4 with respect to the ring 6 at a potential of about 3-4 volts and a current level of about 3 milliamperes for a total power output of about 10 milliwatts. Note that a sensing function could be added by incorporating an electro-optical transducer into the component array 28. Electrical sense signals would then be converted to optical signals and placed on the fiber optic element or bundle 36 for delivery to a sensing unit (not shown). Figure 3 illustrates an exemplary construction of the component array 28 in which the array comprises a photodiode array 28a for receiving optical pacing signals from the fiber optic element or bundle 36 and a light emitting diode 28b for delivering optical sensing signals to the fiber optic element or bundle 36. The components 28a and 28b are mounted on a circuit substrate 28c that is electrically connected to an electrical circuit unit 28d, that may include amplifiers, oscillators, a microprocessor and other devices that can assist electrical pulse delivery and biological sensing functions. Turning now to Figure 4, another embodiment of the invention is shown in which a modified hermetic housing provides a complete electrode termination pair 142. The electrode termination pair 142 includes a tip 144 and a ring 146 that are constructed as metallic coatings formed on the hermetic housing, which is designated by reference numeral 148. An electrically conductive coating 150 formed at the distal end of the housing 148 provides the tip 144. An electrically conductive coating 152 formed at the proximal end of the housing 148 provides the ring 146. The difference between Figures 5A and 5B is that both the inside and the outside surfaces of the housing 148 are coated in Figure 5A, whereas only the outer surface of the housing 148 is coated in Figure 5B. Figures 5A and 5B also show that the component array 28 of Figures 1-3 can be hermetically sealed within the housing 148 via the hermetic seal 26. The proximal end of the housing 148 may then be secured to the distal end of the photonic catheter 12, and the fiber optic element or array 36 can be connected to the component array 28 via the hermetic terminal 38. The component aπay 28 is electrically connected to the tip 144 and the ring 146 via the electrical leads 32 and 30, respectively.
Figure 6 shows an exemplary implementation of the component array 28 within the housing 148. This component array configuration is identical to the component array configuration of Figure 4, and the description thereof will not be repeated here. Turning now to Figure 7, another embodiment of the invention is shown in which a modified hermetic housing again provides a complete electrode termination pair 242. The electrode termination pair 242 includes a tip electrode 244 and a ring electrode 246 that are constructed as electrically conductive band coatings on the hermetic housing, which is designated by reference numeral 248. A shallow well 250 formed near the distal end of the housing 248 may be used to mount the tip 244. A shallow well 252 formed toward the proximal end of the housing 248 may be used to mount the ring 246.
Figure 8 also shows that the component array 28 of Figures 1-3 can be hermetically sealed within the housing 248 via the hermetic seal 26. The proximal end of the housing 248 may then be secured to the distal end of the photonic catheter 12, and the fiber optic element or array 36 can be connected to the component array 28 via the hermetic terminal 38. The component array 28 is electrically connected to the tip 244 and the ring 246 via the electrical leads 32 and 30, respectively. Note that the lead 32 feeds through a small hole 254 formed in the housing 248 in order to reach the tip 244. Similarly, the lead 30 feeds through a small hole 256 formed in the housing 248 in order to reach the ring 246.
Figure 9 shows an exemplary implementation of the component aπay 28 within the housing 248. This component array configuration is identical to the component array configuration of Figure 4, and the description thereof will not be repeated here.
Turning now to Figure 10, an implantable pacemaker 302 is shown that may be constructed in accordance with the present invention. The pacemaker 302 includes a first (main) enclosure 304 that is connected to the proximal end 306 of a photonic catheter 308. A distal end 310 of the photonic catheter 308 mounts a hemietic housing 312 constructed in accordance with a suitable one of the embodiments disclosed herein. As also described above, the housing 312 can form all or part of a tip/ring electrode termination pair 314, and will house a component array 28 containing suitable electrical and optical components to perform whatever pacing and/or sensing functions are required.
Turning now to Figure 11, a wearable pacemaker 402 is shown that may be constructed in accordance with the present invention. The pacemaker 402 includes a first (main) enclosure 404 that is connected to the proximal end 406 of a photonic catheter 408. A distal end 410 of the photonic catheter 408 mounts a hermetic housing 412 constructed in accordance with a suitable one of the embodiments disclosed herein. As also described above, the housing 412 can form all or part of a tip/ring electrode teraiination pair 414, and will house a component array 28 containing suitable electrical and optical components to perform whatever pacing and/or sensing functions are required.
While various embodiments of the present invention have been shown and described, it should be apparent that many variations and alternative' embodiments could be implemented in accordance with the invention. For example, although only a single hermetic housing is shown being attached to the distal end of a photonic catheter, a chain of several hermetic housings can be used, each containing one or more electrical and/or optical components for performing one or more biologically useful functions relative to an implanted patient. In addition, although the hermetic housings are shown to be adapted to mount, or to function as, an electrode or an electrode pair, the housings could be implemented without electrodes thereon in device implementations where there are other structures that mount, or function as, electrodes.
It is understood, therefore, that the present invention is not to be in any way limited except in accordance with the spirit of the appended claims and their equivalents.

Claims

What is claimed is:
1. A hermetic housing for mounting to a distal end of a photonic catheter and adapted to house an optical component therein, comprising: a housing body having a proximal end and a distal end; a hermetically sealed interior in said housing body for enclosing the optical component therein; said proximal end of said housing body being adapted to mount to a distal end of a photonic catheter having a fiber optic element; and a hermetic terminal allowing said fiber optic element to communicate with said housing body interior.
2. The hermetic housing as claimed in claim 1, wherein said housing body is made from an electrically conductive material of low magnetic susceptance.
3. The hermetic housing as claimed in claim 1, wherein said housing body is made from a non-electrically conductive material and has a coating layer comprising an electrically conductive material of low magnetic susceptance to allow said hermetic housing to function as a ring electrode.
4. The hermetic housing as claimed in claim 3, wherein said distal end of said housing is adapted to mount to a proximal end of an insulative stub carrying a tip electrode structure, and wherein said housing includes a second hermetic terminal allowing an electrical lead to extend from said housing body interior through said stub to said tip electrode structure.
5. The hermetic housing as claimed in claim 1, wherein said housing body is made from a non-electrically conductive material and has a pair of spaced coating layers comprising an electrically conductive material of low magnetic susceptance to allow said hermetic housing to function as a combination tip and ring electrode.
6. The hermetic housing as claimed in claim 3, wherein said housing body is made from a ceramic material and said tip and said ring coatings are metallic coatings selected from the group comprising platinum, titanium, and alloys thereof.
7. The hermetic housing as claimed in claim 4, wherein said housing body is made from a ceramic material and said tip and said ring coatings are metallic coatings selected from the group comprising platinum, titanium, and alloys thereof.
8. The hermetic housing as claimed in claim 5, wherein said housing body is made from a ceramic material and said tip and said ring coatings are metallic coatings selected from the group comprising platinum, titanium, and alloys thereof.
9. The hermetic housing as claimed in claim 1, wherein said housing body interior houses an opto-electrical transducer in the form of a photodiode array.
10. The hermetic housing as claimed in claim 9, wherein said housing body interior houses an electro-optical transducer in the form of a light emitting diode and a sense signal amplifier.
11. The hermetic housing as claimed in claim 10, wherein said housing body interior houses a microprocessor.
12. The hermetic housing as claimed in claim 11, wherein said housing body interior houses components for sensing one or more of core body temperature, cardiac R waves, and partial oxygen pressure.
13. In a photonic pacemaker, a hermetic component carrying housing, comprising: a housing body having a proximal end and a distal end; a heraietically sealed interior in said housing body enclosing an optical component therein; said proximal end of said housing body being mounted to a distal end of a photonic catheter carrying a fiber optic element; and a hermetic terminal allowing said fiber optic element to communicate with said housing body interior.
16. The heπnetic component carrying housing as claimed in claim 13, wherein said housing body is made from an electrically conductive material of low magnetic susceptance.
17. The hermetic component carrying housing as claimed in claim 13, wherein said housing body is made from a non-electrically conductive material and has a coating layer comprising an electrically conductive material of low magnetic susceptance to allow said hermetic housing to function as a ring electrode.
18. The hermetic component carrying housing as claimed in claim 17, wherein said distal end of said housing is mounted to a proximal end of an insulative stub carrying a tip electrode structure, and wherein said housing includes a second hermetic terminal allowing an electrical lead to extend from said housing body interior through said stub to said tip electrode structure.
19. The hermetic component carrying housing as claimed in claim 13, wherein said housing body is made from a non-electrically conductive material and has a pair of spaced coating layers comprising an electrically conductive material of low magnetic susceptance to allow said hermetic housing to function as a combination tip and ring electrode.
20. The hermetic component carrying housing as claimed in claims 18, wherein said housing body is made from a ceramic material and said tip and said ring coatings are metallic coatings selected from the group consisting of platinum, titanium and alloys thereof.
21. The hermetic component carrying housing as claimed in claims 19, wherein said housing body is made from a ceramic material and said tip and said ring coatings are metallic coatings selected from the group consisting of platinum, titanium and alloys thereof.
22. The heraietic component carrying housing as claimed in claim 13, wherein said housing body interior houses an opto-electrical transducer in the form of a photodiode array.
23. The hermetic component carrying housing as claimed in claim 22, wherein said housing body interior houses an electro-optical transducer in the form of a light emitting diode and a sense signal amplifier.
24. The hermetic component carrying housing as claimed in claim 23, wherein said housing body interior houses a microprocessor.
25. The hermetic component carrying housing as claimed in claim 24, wherein said housing body interior houses components for sensing one or more of core body temperature, cardiac R waves, and partial oxygen pressure.
26. A medical system, comprising: a control unit adapted to generate body tissue stimulation signals; a photonic catheter having a proximal end in communication with said control unit and a fiber optic element for carrying optical stimulation signals, said catheter further having a distal end; and a hermetic housing; said hermetic housing including, a housing body having a proximal end and a distal end, a hermetically sealed interior in said housing body enclosing an optical component therein, said proximal end of said housing body being mounted to said distal end of said photonic catheter, a hermetic terminal allowing said photonic catheter fiber optic element to communicate with said housing body interior, and means for delivering said stimulation signals to implanted body tissue.
27. A medical system, comprising: a control unit adapted to receive sensing signals representing one or more body function parameters; a photonic catheter having a proximal end in communication with said control unit and a fiber optic element for carrying optical sensing signals, said catheter further having a distal end; and a hermetic housing; said heπnetic housing including, a housing body having a proximal end and a distal end, a hermetically sealed interior in said housing body enclosing an optical component therein, said proximal end of said housing body being mounted to said distal end of said photonic catheter, a hermetic terminal allowing said photonic catheter fiber optic element to communicate with said housing body interior, and means for sensing body function parameters and generating said sensing signals.
28. A photonic catheter unit adapted for use with a medical system, comprising: a hermetic component caπying housing; a fiber optic element for carrying optical stimulation signals between a control unit located at a proximal end of fiber optic element and said hermetic component carrying housing located at a distal end of said fiber optic element; and a biocompatible sheath covering said fiber optic element; said hermetic component carrying housing including, a housing body having a proximal end and a distal end, a hermetically sealed interior in said housing body enclosing an optical component therein, said proximal end of said housing body being mounted to said distal end of fiber optic element, a hermetic teπninal allowing said photonic catheter fiber optic element to communicate with said housing body interior, and means for delivering said stimulation signals to implanted body tissue.
29. A photonic catheter unit adapted for use with a medical system, comprising: a hennetic component caπying housing; a fiber optic element for carrying optical sensing signals between a control unit located at a proximal end of fiber optic element and said hermetic component carrying housing located at a distal end of said fiber optic element; and a biocompatible sheath covering said fiber optic element; said hermetic component carrying housing including, a housing body having a proximal end and a distal end, a hermetically sealed interior in said housing body enclosing an optical component therein, said proximal end of said housing body being mounted to said distal end of fiber optic element, a hermetic terminal allowing said photonic catheter fiber optic element to communicate with said housing body interior, and means for sensing one or more body function parameters and generating said sensing signals.
PCT/US2002/034746 2001-10-31 2002-10-30 Hermetic component housing for photonic catheter WO2003037399A2 (en)

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