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WO2008020849A1 - Outil chirurgical pour implantation d'électrode - Google Patents

Outil chirurgical pour implantation d'électrode Download PDF

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Publication number
WO2008020849A1
WO2008020849A1 PCT/US2006/032231 US2006032231W WO2008020849A1 WO 2008020849 A1 WO2008020849 A1 WO 2008020849A1 US 2006032231 W US2006032231 W US 2006032231W WO 2008020849 A1 WO2008020849 A1 WO 2008020849A1
Authority
WO
WIPO (PCT)
Prior art keywords
top portion
surgical tool
electrode array
base
rounded point
Prior art date
Application number
PCT/US2006/032231
Other languages
English (en)
Inventor
Robert J. Greenberg
Da-Yu Chang
Original Assignee
Second Sight Medical Products, 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 Second Sight Medical Products, Inc. filed Critical Second Sight Medical Products, Inc.
Priority to PCT/US2006/032231 priority Critical patent/WO2008020849A1/fr
Publication of WO2008020849A1 publication Critical patent/WO2008020849A1/fr

Links

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
    • A61N1/0526—Head electrodes
    • A61N1/0543—Retinal electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36046—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the eye

Definitions

  • Tha present invention is generally directed to implantable medical devices, in particular to a tool for implanting electrodes and th ⁇ ir association wires.
  • LeRoy passed the discharge of a Leyden jar through the orbit of a man who was blind from cataract and the patient saw "flames passing rapidly downwards.” Ever since, them has been a curiosity with electrically elicited visual perception. The general concepts of electrical stimulation of retinal cells to produce these flashes of light or phosphenes has been known for quits some time. Based on these general principles, some early attempts at devising a prosthesis for aiding the visually impaired have included attaching electrodes to the head or eyelids of patients. While some of these early attempts met with some limited success, these early prosthesis devices were large, bulky and could not produce adequate simulated vision to truly aid the visually impaired.
  • Neural tissue can be artificially stimulated and activated by prosthetic devices that pass pulses of electrical current through electrodes on such a device.
  • the passage of current causes changes in electrical potentials across neuronal membranes, which can initiate neuron action potentials, which are the means of information transfer in the nervous system.
  • Bullara US Pat. No. 4,573,481 patented an electrode assembly for surgical implantation on a nerve.
  • the matrix was silicone with embedded iridium electrodes.
  • the assembly fit around a nerve to stimulate it.
  • the Michelson '933 apparatus includes an array of photosensitive devices on its surface that are connected to a plurality of electrodes positioned on the opposite surface of the device to stimulate the retina. These electrodes are disposed to form an array similar to a "bed of nails” having conductors which impinge directly on the retina to stimulate the retinal cells. Such a device increases the possibility of retinal trauma by the use of its "bed of nails” type electrodes that impinge directly on the retinal tissue.
  • retinal tacks The art of implanting an intraocular prosthetic device to electrically stimulate the retina was advanced with the introduction of retinal tacks in retinal surgery.
  • De Juan, et al. at Duke University Eye Center inserted retinal tacks into retinas in an effort to reattach retinas that had detached from the underlying choroid, which is the source of blood supply for the outer retina and thus the photoreceptors. See, e.g., E. de Juan, et al., 99 Am. J. Ophthalmol. 272 (1985).
  • These retinal tacks have proved to be biocompatible and remain embedded in the retina, and choroid/sclera, effectively pinning the retina against the choroid and the posterior aspects of the globe.
  • Retinal tacks are one way to attach a retinal array to the retina.
  • the retina is extraordinarily fragile.
  • retinal neurons are extremely sensitive to pressure; they will die if even a modest intraocular pressure is maintained for a prolonged period of time.
  • Glaucoma which is one of the leading causes of blindness in the world, can result from a chronic increase of intraocular pressure of only 10 mm Hg.
  • the retina if it is perforated or pulled, will tend to separate from the underlying epithelium, which will eventually render it functionless.
  • attachment of a conventional prosthetic retinal electrode device carries with it the risk of damage to the retina, because of the pressure that such a device could exert on the retina.
  • bed of nails electrode array which in combination with processing circuitry amplifies and analyzes the signal received from the tissue and/or which generates signals which are sent to the target tissue.
  • the penetrating electrodes are damaging to the delicate retinal tissue of a human eye and therefore are not applicable to enabling sight in the blind.
  • the device contains perhaps a hundred small pillars each of which penetrates the visual cortex in order to interface with neurons more effectively.
  • the array is strong and rigid and may be made of glass and a semiconductor material.
  • the electrode is made of a rigid glass substrate.
  • the lead wires which contact the electrodes are indium tin oxide covered with a conducting metal and coated with platinum containing metal.
  • the electrodes are indium tin oxide or a highly electrically conductive metal.
  • lead-wire ' insulating materials are disclosed including resins.
  • US Pat. No. 5,935,155 issued to Humayun, et al. in 1999, describes a visual prosthesis and method of using it.
  • the Humayun patent includes a camera, signal processing electronics and a retinal electrode array.
  • the retinal array is mounted inside the eye using tacks, magnets, or adhesives. Portions of the remaining parts may be mounted outside the eye.
  • the Humayun patent describes attaching the array to the retina using retinal tacks and/or magnets. This patent does not address reduction of damage to the retina and surrounding tissue or problems caused by excessive pressure between the retinal electrode array and the retina.
  • Mortimer's US Pat NO. 5,987,361 of 1999 disclosed a flexible metal foil structure containing a series of precisely positioned holes that in turn define electrodes for neural stimulation of nerves with cuff electrodes.
  • Silicone rubber may be used as the polymeric base layer. This electrode is for going around nerve bundles and not for planar stimulation.
  • the retina is also very sensitive to heat. Implanting a retinal prosthesis fully within the eye may cause excessive heat buildup damaging the retina. It is, therefore, advantageous to implant an electrode array on the retina attached by a cable to heat producing electronics which are implanted somewhere outside the eye. If no electronics are implanted in the eye, it is necessary to run one wire for each electrode from the electronics package to the electrode array. These wires must be extremely thin. While grouping them together in a cable with a protective sheath provides some protection, the array and cable must be handled carefully to prevent damage to the electrode array or cable.
  • Published US patent application 2002/0099420, Chow et al. describes a surgical tool for implantation of a retinal electrode array. The Chow device is a tube which is placed into the eye and to the implant location. Then fluid flows though the tube pushing the electrode array into place.
  • the present invention is a surgical tool for implanting an electrode array and its connected cable within an eye.
  • the insertion tool is used to aid the surgeon in pulling the electrode wire and array through the scull, four- rectus muscles of the eye, and the sclera.
  • the insertion tool consists of a medical grade ABS material that is commonly used in various medical products.
  • FIG. 1 is a perspective view of the retinal electrode array assembly showing the electrodes and signal conductors as well as mounting aperture for tacking the assembly inside the eye, wherein both the array and its associated electronics are located inside the eye.
  • FIG. 2 is a perspective view of the retinal electrode array assembly showing the electrodes and signal conductors as well as mounting aperture for tacking the assembly inside the eye, wherein the associated electronics are located outside the eye.
  • FIG. 3 is a perspective view of the retinal electrode array assembly wherein the array is installed inside the eye and the associated electronics are installed outside the eye at some distance from the sclera wherein the feeder cable contains both a coiled cable leading between the electronics and the sclera and a series of fixation tabs along the feeder cable for securing the feeder cable by suture.
  • FIG. 4 is a cross-sectional view of the retinal electrode array, the sclera, the retina and the retinal electrode array showing the electrodes in contact with the retina.
  • FIG. 5 depicts a cross-sectional view of the retinal electrode array showing a strain relief slot, strain relief internal tab and a mounting aperture through a reinforcing ring for a mounting tack to hold the array in position.
  • FIG. 6 illustrates a cross-sectional view of the retinal electrode array showing a strain relief slot and a ferromagnetic keeper to hold the array in position.
  • FIG. 7 illustrates a cross-sectional view of the retinal electrode array showing a strain relief slot and a mounting aperture through a reinforcing ring for a mounting tack to hold the array in position, wherein the strain relief internal tab containing the mounting aperture is thinner than the rest of the array.
  • FIG. 8 is a perspective view of the preferred insertion tool, for inserting the array of figures 1 - 7, having an curved tongs and a spring base.
  • FIG. 9 is a mechanical drawing of an alternate embodiment of the insertion tool illustrated in figure 8 having straight tongs and a.
  • FIG. 10 is a perspective view of an alternate embodiment using a hinged base.
  • FIG. 11 is a perspective view of an alternate embodiment using curved tongs and a hinged base.
  • Fig. 1 provides a perspective view of a preferred embodiment of the retinal electrode array (implanted by the surgical too of the resent invention), generally designated 2, comprising oval-shaped electrode array body 4, a plurality of electrodes 6 made of a conductive material, such as platinum or one of its alloys, but that can be made of any conductive biocompatible material such as iridium, iridium oxide or titanium nitride, and single reference electrode 6A made of the same material as electrode 6, wherein the electrodes are individually attached to separate conductors 8 made of a conductive material, such as platinum or one of its alloys, but which could be made of any biocompatible conductive material, that is enveloped within an insulating sheath 10, that is preferably silicone, that carries an electrical signal to each of the electrodes 6.
  • a conductive material such as platinum or one of its alloys
  • Electrode array body means that the body may approximate either a square or a rectangle shape, but where the corners are rounded.
  • the reference electrode 6A is not necessarily stimulated, but is attached to a conductor, as are electrodes 6.
  • the electrodes could be used in another application as sensors to transmit electrical signals from a nerve.
  • the electrodes 6 transmit an electrical signal to the eye while reference electrode 6A may be used as a ground, reference, or control voltage.
  • Electrode array body 4 is made of a soft material that is compatible with the body.
  • array body 4 is made of silicone having a hardness of about 50 or less on the Shore A scale as measured with a durometer. In an alternate embodiment the hardness is about 25 or less on the Shore A scale as measured with a durometer. It is a substantial goal to have electrode array body 4 in intimate contact with the retina of the eye.
  • Strain relief internal tab 12 defined by a strain relief slot 13 that passes through the array body 4, contains a mounting aperture 16 for fixation of the electrode array body 4 to the retina of the eye by use of a surgical tack, although alternate means of attachment such as glue or magnets may be used.
  • Reinforcing ring 14 is colored and opaque to facilitate locating mounting aperture 16 during surgery and may be made of tougher material, such as high toughness silicone, than the body of the electrode array body to guard against tearing.
  • Signal conductors 8 are located in an insulated flexible feeder cable
  • Signal conductors 8 can be wires, as shown, or in an alternative embodiment, a thin electrically conductive film, such as platinum, deposited by sputtering or an alternative thin film deposition method.
  • the entire retinal electrode array 2 including the feeder cable 18 and electronics 6 are all implanted inside the eye.
  • Electronics 20 may be fixated inside the eye to the sclera by sutures or staples that pass through fixation tabs 24.
  • the conductors are covered with silicone insulation.
  • Grasping handle 46 is located on the surface of electrode array body 4 to enable its placement by a surgeon using forceps or by placing a surgical tool into the hole formed by grasping handle 46. Grasping handle 46 avoids damage to the electrode body that might be caused by the surgeon grasping the electrode body directly. Grasping handle 46 also minimizes trauma and stress-related damage to the eye during surgical implantation by providing the surgeon a convenient method of manipulating electrode array body 4.
  • Grasping handle 46 is made of silicone having a hardness of about 50 on the Shore A scale as measured with a durometer.
  • a preferred embodiment of the electrode array body 4 is made of a very soft silicone having hardness of 50 or less on the Shore A scale as measured with a durometer.
  • the reinforcing ring 14 is made of opaque silicone having a hardness of 50 on the Shore A scale as measured with a durometer.
  • Fig. 2 provides a perspective view of the retinal electrode array assembly 2 wherein the electrode array body 4 is implanted inside the eye and the electronics 20 are placed outside the eye with the feeder cable 18 passing through sclera 30.
  • electronics 38 are attached by fixation tabs 24 outside the eye to sclera 30.
  • Fig. 3 provides a perspective view of retinal electrode array 2 wherein electrode array body 4 is implanted on the retina inside the eye and electronics 38 are placed outside the eye some distance from sclera 30 wherein feeder cable 18 contains sheathed conductors 10 as silicone-filled coiled cable 22 for stress relief and flexibility between electronics 38 and electrode array body 4.
  • Feeder cable 18 passes through sclera 30 and contains a series of fixation tabs 24 outside the eye and along feeder cable 18 for fixating cable 18 to sclera 30 or elsewhere on the recipient subject.
  • Fig. 4 provides a cross-sectional view of electrode array body 4 in intimate contact with retina 32.
  • the surface of electrode array body 4 in contact with retina 32 is a curved surface 28 substantially conforming to the spherical curvature of retina 32 to minimize stress concentrations therein.
  • the decreasing radius of spherical curvature of electrode array body 4 near its edge forms edge relief 36 that causes the edges of array body 4 to lift off the surface of retina 32 eliminating stress concentrations.
  • the edge of electrode array body 4 has a rounded edge 34 eliminating stress and cutting of retina 32.
  • the axis of feeder cable 18 is at right angles to the plane of this cross-sectional view. Feeder cable 18 is covered with silicone.
  • Fig. 5 provides a cross-sectional view of electrode array body 4 showing spherically curved surface 28, strain relief slot 13 and mounting aperture 16 through which a tack passes to hold array body 4 in intimate contact with the eye.
  • Mounting aperture 16 is located in the center of reinforcing ring 14 that is opaque and colored differently from the remainder of array body 4, making mounting aperture 16 visible to the surgeon.
  • Reinforcing ring 14 is made of a strong material such as tough silicone, which also resists tearing during and after surgery.
  • Strain relief slot 13 forms strain relief internal tab 12 in which reinforcing ring 14 is located. Stresses that would otherwise arise in the eye from tacking array body 4 to the eye through mounting aperture 16 are relieved by virtue of the tack being located on strain relief internal tab 12.
  • Fig. 6 provides a cross-sectional view of a preferred embodiment of electrode array body 4 showing ferromagnetic keeper 40 that holds electrode array body 4 in position against the retina by virtue of an attractive force between keeper 40 and a magnet located on and attached to the eye.
  • Fig. 7 is a cross-sectional view of the electrode array body 4 wherein internal tab 12 is thinner than the rest of electrode array body 4, making this section more flexible and less likely to transmit attachment induced stresses to the retina.
  • This embodiment allows greater pressure between array body 4 and the retina at the point of attachment, and a lesser pressure at other locations on array body 4, thus reducing stress concentrations and irritation and damage to the retina.
  • Fig. 8 is a perspective view of the preferred insertion tool 50.
  • the electrode array body 4 and feeder cable 18 are extremely delicate. They must pass through a hole in the scull, pass under the four-rectus muscles of the eye, through the sclera and be attached to the retina.
  • the insertion tool 50 has a rounded point 52 for gently separating muscle and flesh as the tool is passed through.
  • the rounded point 52 is rigidly attached to a base 54 and top 56. Both the base 54 and the top 58 are rounded on the outside and square on the inside. The rounding helps the tool pass through flesh without causing damage.
  • the electrode body 4 is place between the base 54 and top 58. Spring force traps the electrode array body 4 between the base 54 and top 58. The too!
  • the tool is fashioned from an inert biocompatible material that includes resilient elastic properties such ABS, stainless steel or titanium. ABS is suitable as a single use, disposable surgical tool while stainless steel or titanium could be steam sterilized and reused.
  • the surgeon can pass the tool 50, electrode array body 4 and the feeder cable 18 in the same manner as a needle and thread.
  • the preferred surgical tool 50 is curved to promote easy movement around the eye.
  • the curvature of the tool generally conforms to the curvature of the outside of the sclera.
  • the surgical tool may be strait as shown in figure 9.
  • Fig. 9 shows an alternate embodiment of the surgical tool 150.
  • the alternate surgical tool 150 has a strait base 54 and top 58, while retaining the radius 164 and rounded point 152 of the preferred embodiment.
  • Fig. 10 shows another alternate embodiment. Rather than relying on spring force to hold the electrode array body 4 and the feeder cable 18 in the tool 250.
  • the base 254 is rigidly attached to the rounded point 252, but the top 258 is attached by a hinge 256 to the base 254 and rounded point 252. This allows the surgeon more control of the force applied to the electrode array body 4 and the feeder cable 18.
  • the hinge 256 further provides for easier loading and unloading of the electrode array.
  • This embodiment retains the radius 264 to provide even pressure along the lengths of the base 254 and the top 258.
  • This embodiment further includes notches 260 in the base 254, which mate with guides 262 in the top 258 to hold the electrode array body 4 and the feeder cable 18 in the tool 250, by holding the top 258 and base 254 together.
  • the radius 264 reduces stress concentrations that could crack the tool at the junction of the base and top with the base and top are deflected while loading or unloading the electrode array.
  • Fig. 11 shows another alternate embodiment, similar to that shown in
  • the base 354 is rigidly attached to the rounded point 352, but the top 358 is attached by a hinge 356 to the base 354 and rounded point 352.
  • the hinge 356 further provides for easier loading and unloading of the electrode array.
  • This embodiment retains the radius 264 to provide even pressure along the lengths of the base 354 and the top 358.
  • the base 354 and top 358 are curved to allow for easier insertion of the tool.
  • This embodiment further includes a keeper 360 attached to the base 354, which covers the top 358 to limit movement and prevents opening the tool and possibly dropping the array body 4.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un outil chirurgical permettant d'implanter une matrice d'électrode rétinienne et son câble raccordé à un support orbitaire. L'instrument d'insertion est utilisé pour aider le chirurgien à faire passer le fil de l'électrode et la matrice à travers le crâne, les quatre muscles droits de l'œil, et la sclérotique. L'outil d'insertion est constitué d'un matériau médical de qualité ABS qui est couramment utilisé dans divers produits médicaux.
PCT/US2006/032231 2006-08-16 2006-08-16 Outil chirurgical pour implantation d'électrode WO2008020849A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2006/032231 WO2008020849A1 (fr) 2006-08-16 2006-08-16 Outil chirurgical pour implantation d'électrode

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2006/032231 WO2008020849A1 (fr) 2006-08-16 2006-08-16 Outil chirurgical pour implantation d'électrode

Publications (1)

Publication Number Publication Date
WO2008020849A1 true WO2008020849A1 (fr) 2008-02-21

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Family Applications (1)

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PCT/US2006/032231 WO2008020849A1 (fr) 2006-08-16 2006-08-16 Outil chirurgical pour implantation d'électrode

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112716689A (zh) * 2020-12-14 2021-04-30 微智医疗器械有限公司 眼科手术器械

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0460320A2 (fr) * 1989-08-08 1991-12-11 Alan Y. Chow Dispositif à rétine artificielle
US20040039401A1 (en) * 2000-03-31 2004-02-26 Chow Alan Y. Implant instrument
US20060253124A1 (en) * 2002-07-26 2006-11-09 Robert Greenberg Surgical tool for electrode implantation

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0460320A2 (fr) * 1989-08-08 1991-12-11 Alan Y. Chow Dispositif à rétine artificielle
US20040039401A1 (en) * 2000-03-31 2004-02-26 Chow Alan Y. Implant instrument
US20060253124A1 (en) * 2002-07-26 2006-11-09 Robert Greenberg Surgical tool for electrode implantation

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
HUSAIN DEEBA ET AL: "SURGICAL APPROACHES TO RETINAL PROSTHESIS IMPLANTATION", INTERNATIONAL OPHTHALMOGY CLINICS, LITTLE, BROWN AND CO., BOSTON, US, vol. 44, no. 1, 21 December 2004 (2004-12-21), pages 105 - 111, XP009079946, ISSN: 0020-8167 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112716689A (zh) * 2020-12-14 2021-04-30 微智医疗器械有限公司 眼科手术器械
CN112716689B (zh) * 2020-12-14 2023-09-15 微智医疗器械有限公司 眼科手术器械

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