| Apparatus and method for stimulation of nerves and automated control of surgical instruments -> Monitor Keywords |
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Apparatus and method for stimulation of nerves and automated control of surgical instrumentsApparatus and method for stimulation of nerves and automated control of surgical instruments description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20080077200, Apparatus and method for stimulation of nerves and automated control of surgical instruments. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS-REFERENCE TO RELATED APPLICATIONS [0001]This application claims benefit of U.S. Provisional Patent Application No. 60/826,538 (Attorney Docket 5020.001PV1) filed on Sep. 21, 2006, titled "MINIATURE APPARATUS AND METHOD FOR OPTICAL STIMULATION OF NERVES AND OTHER ANIMAL TISSUE," which is incorporated herein by reference in its entirety. This application is also related to U.S. patent application Ser. No. 11/420,729 (Attorney Docket 5032.009US1) filed on May 26, 2006 entitled "APPARATUS AND METHOD FOR OPTICAL STIMULATION OF NERVES AND OTHER ANIMAL TISSUE" and to U.S. patent application Ser. No. 11/___,___ (Attorney Docket 5032.020US1) filed on even date herewith entitled "APPARATUS AND METHOD FOR STIMULATION OF NERVES AND AUTOMATED CONTROL OF SURGICAL INSTRUMENTS," which are each incorporated herein by reference in their entirety. FIELD OF THE INVENTION [0002]The invention relates generally to surgical instruments, and more particularly to methods and apparatus to stimulate a nerve, sense a result of the nerve stimulation, and control a surgical instrument, such as an ablation laser, based on the sensed result; for example controlling the ablation laser to suppress ablation pulses to avoid damaging vital nerves while removing other diseased tissue, or to enable ablation pulses to remove damaged nerve tissue. BACKGROUND OF THE INVENTION [0003]A nerve can be stimulated in a number of different ways, including electrical, mechanical, thermal, chemical, and now optical. A nerve is a filament of neural tissue composed of cells each having a cell body and one or more axons and dendrites. The axons extend peripherally as either myelinated or unmyelinated fibers. A chain of Schwann cells surrounds each myelinated nerve fiber with a multilayered myelin sheath. Groups of unmyelinated fibers are associated with single Schwann cells. Both types of nerve fibers are bound by endoneurium to form bundles, or fascicles. A perineurial membrane surrounds each fascicle. Groups of fascicles are held together by internal and external epineurium to form the peripheral nerves. The cell body of a motor neuron lies in the anterior horn of the spinal cord, while the cell body of a sensory neuron is located in the dorsal root ganglion, near the cord. (Christine Cheng; See Nerve Compression Syndromes of the Upper Limb, by Martin Dunitz, published by Taylor & Francis Group, 2002.) [0004]Functional magnetic-resonance-imaging (FMRI) systems use extremely strong magnetic fields in generating images of an animal subject (e.g., a human) to discern functions and abnormalities of various portions of the body, and in particular, of the brain (e.g., during various mental activities or thought patterns). The high static magnetic fields (Bo fields) created by an MRI machine create a danger of projectile accidents from any object having magnetic properties that may be near the MRI machine. Using metal probes to deliver electrical stimulation to nerves of a subject poses one such danger. It would be desirable to stimulate a nerve without using metal probes. [0005]Further, it is desirable to cause a controlled stimulation of individual nerves. U.S. Pat. No. 6,921,413 issued to Mahadevan-Jansen et al. on Jul. 26, 2005, and titled "Methods and Devices for Optical Stimulation of Neural Tissues," is incorporated herein by reference. Mahadevan-Jansen et al. note that traditional methods of stimulation include electrical, mechanical, thermal, and chemical. A neuron will propagate an electrical impulse (a nerve action potential) in response to a stimulus. The most common form of applying such stimulation is to form a transient current or voltage pulse applied through electrodes. Electrical, mechanical, and chemical stimulations have many limitations. Stimulation by such methods typically results in non-specific stimulation of neurons and/or damage to neurons. Difficulty exists in recording electrical activity from the neuron due to an electrical artifact created by the stimulus. To stimulate only one or a few neurons, fragile microelectrodes need to be fashioned and carefully inserted into the tissue to be stimulated. Such techniques do not easily lend themselves to implantable electrodes for long-term use in stimulation of neural tissue. Mahadevan-Jansen et al. describe the use of low-power light from a free-electron laser (FEL) for optically stimulating selected individual nerve cells in vivo, while at the same time not stimulating neighboring cells with the laser light. Unfortunately, FELs are expensive, large, awkward and unwieldy. [0006]Further, some conventional optical systems include some magnetic materials, making them unsuitable for use near MRI systems. [0007]In other conventional neural-stimulation systems, 110-volt AC (wall power) is used to control and/or drive the laser components, with electrical, cooling-fluid, and/or optical tethers between a delivery head and other portions of the equipment, making such systems clumsy and/or perhaps somewhat dangerous to use if relatively high voltages are present in the hand-held portion. For example, U.S. Pat. No. 5,548,604 issued to Toepel on Aug. 20, 1996 entitled "Compact hand held medical device laser" describes a palm-sized laser device having a hand-held housing containing a solid state crystal lase material rod, a flashlamp (for pulsed pump light) within a reflective light-coupling cavity and a fluid-cooling chamber adapted to receive and exhaust coolant fluid. [0008]In view of shortcomings in such conventional devices, there is a need for devices and methods that can provide inexpensive, compact, optionally non-magnetic, optionally having non-wall-powered power supplies, and/or easy-to-use interfaces and form factors for optical stimulation of nerves. BRIEF SUMMARY OF THE INVENTION [0009]In some embodiments, the invention provides a method and self-powered (e.g., battery-powered) and/or hand-held apparatus for stimulating nerves using either an infra-red (IR) diode laser or light-emitting diode (LED) (e.g., one running at a wavelength of about 1.87 microns) or a diode-pumped solid-state laser (e.g., using a semiconductor laser diode as a pump source of optical radiation and an optically pumped semiconductor or optically pumped rare-earth-doped fiber laser cavity) running at a wavelength of 2.1 microns (e.g., a 785-micron-wavelength laser diode pumping a Tm/Ho solid-state crystal or fiber), or a laser diode operating at a wavelength of between about 1.8 and about 2.2 microns. In other embodiments, the invention uses other wavelengths that are efficacious in optical stimulation of animal tissue such as a nerve. [0010]In some embodiments, the apparatus is at least mostly embedded in a self-contained hand-held form factor such as a light pen, pointer and/or wand that can be manually used to control, direct and/or shutter the light. In some embodiments, the hand-held device includes an embedded laser diode used to obtain optical radiation (optionally directed at least in part in an embedded optical fiber) that has a suitable wavelength and optical power sufficient to optically stimulate the nerve. In other embodiments, one or more LEDs, one or more diode lasers, or a combination of one or more LEDs and one or more diode lasers is used to obtain the stimulation light. [0011]In some embodiments, the hand-held device of the present invention includes one or more internal power sources, such as battery cells, to provide self-contained electrical power to the laser diode and/or other internal components. In some embodiments, at least some of the metal portions of the battery and other internal electrical wiring connections are all or substantially all made of a non-magnetic electrically conductive material such as copper, in order to be usable near MRI equipment. [0012]In some embodiments, one or more free-space or bulk optical components (such as air gaps, lenses, prisms and the like, in contrast to enclosing the entire optical path in optical fibers) are used in the hand-held device of the present invention. In some embodiments, one or more IR and/or visible lasers are implemented on a semiconductor chip, and one or more such chips are mounted to a housing (such as a metal or plastic "can" having a front lens) such that the combined optical output of the laser(s)/LED(s) starts in close proximity and is immediately collimated as a single beam and focussed by a single train of lenses and other optical components. In other embodiments, at least one beamsplitter/beam combiner is used to combine light from two or more sources into a single output beam. [0013]In other embodiments, the IR nerve-stimulation optical signal is carried in an optical fiber, and, either sharing a single optical fiber or passing in one or more separate fibers next to the optical fiber that carries the IR nerve-stimulation optical signal, the invention also includes a visible-laser or visible-LED signal that illuminates and points out the area (e.g., the nerve) being stimulated. In still other embodiments, a high-power surgical and/or therapeutic laser signal is added in conjunction with the IR nerve-stimulation signal and/or visible pointer laser. For example, in some embodiments, a visible laser is projected to point out to the surgeon where the IR nerve-stimulation laser signal will be applied; the surgeon then activates the IR nerve-stimulation laser signal and observes the response (for example, phantom-limb pain of an amputee); and once the observed response determines the nerve location to be treated, the surgical and/or therapeutic laser signal is applied to that identified location. In other embodiments, for example to avoid accidentally cutting a facial nerve during surgery, the IR nerve-stimulation laser signal is pointed to a location that the surgeon wants to cut or ablate (in some embodiments, this point is illuminated by the visible pointer laser beam) but wants to cut only if no nerve is at that point; the surgeon then activates the IR nerve-stimulation laser signal and observes the response (for example, a muscle contraction that can be seen by the surgeon or sensed by a suitable sensor taped or otherwise affixed to the skin); but in this case, the observed response determines that a location to be treated includes a desired nerve, and the surgical and/or therapeutic laser signal is inhibited from being applied to that identified location. In some embodiments, the nerve-response sensor generates a signal that inhibits activation of the surgical laser. [0014]The present invention, with its ability to precisely stimulate a single nerve or a very small area of a brain (optionally with no magnetic material near the subject, who, in some embodiments, may be a human patient requiring medical care) is a gateway technology that opens broad areas of medicine and surgery. In some embodiments, an enlarged digital or video image of the surgery site is displayed, and as the surgeon optically stimulates the various nerves or areas, the image is annotated (e.g., color-coded as a map of nerve function) to provide a record of which response was observed for each of the different areas stimulated. In some embodiments, once the annotated map is sufficiently complete, the surgeon can input graphical annotation to the computer identifying the extent or the exact area to which treatment is to be permitted, the visible signal (showing where the fiber is pointing) is inputted and compared to the map, such that the controller allows the surgical and/or therapeutic laser signal to be applied only to the identified allowed area. [0015]As used herein, "optical stimulation of nerves" refers to stimulation caused by impinging light onto nerve tissue, regardless of the wavelength of the light (ultraviolet, visible, or infrared, wherein the term "light" is not necessarily restricted to light in the visible range of 400- to 700-nanometer wavelengths). The nerve being stimulated can be any nerve, such as motor or sensory nerves in the peripheral nervous system, nerve tissue of the central nervous system (nerves within the brain and spinal cord), the cranial nerves (e.g., the optic nerve, the olfactory nerve, the auditory nerve, and the like), optical or auditory nerves, the autonomic nervous system, as well as brain tissue and/or any other neural tissue. Thus, the tissue to which optical stimulation is applied need not itself be a "nerve" as conventionally defined, but could include brain tissue that when stimulated by light initiates a response similar to that carried by a nerve, e.g., an action potential that includes electrical and/or chemical components, and which is propagated to a location some distance from the point that was optically stimulated. As used herein, the term "subject" is an inclusive term that refers to any animal whose nerves may be stimulated by light, as the term light has been defined above; this includes non-mammalian and mammalian species, including humans, and including especially humans who may be patients receiving professional medical care. As used herein, the term "optical-fiber structure" is an inclusive term that includes a single optical fiber as well as a bundle of individual optical fibers, a fused bundle of optical fibers, star couplers, and depending on the context optionally includes ferrules, lenses, and the like used to couple light into and out of the optical fiber structure. [0016]In some embodiments, the present invention includes at least some of the following in a small hand-held portable device powered by a self-contained energy-storage device (e.g., batteries or other power source, such as capacitors, chemical energy, rotational flywheel energy, spring energy and the like; and/or a self-contained power receiver such as a coil for receiving AC magnetic or RF energy, a photovoltaic cell for receiving optical energy, and the like), one or more light-emitting sources (that emit tissue-stimulation wavelengths) powered by the self-contained energy-storage device, an optional light-beam combiner coupled to combine two or more optical beams into a single optical beam, optics to focus and deliver light to a nerve, a trigger or activation mechanism, a light-emitting-source controller (e.g., in some embodiments, this includes electronics to condition and control electricity to laser diodes), one or more visible-light-emitting sources such as LEDs and/or laser diodes (that emit light used to point at or identify the tissue area being (or to be) stimulated and a disposable sheath. In some embodiments, the sheath includes or incorporates a lens and/or other portions of the optics to focus the light from the light sources to a particular spot size and/or shape. In some embodiments, a plurality of different interchangeable sheaths and/or lens tips are provided, each having a different spot size and/or shape, allowing the surgeon or technician to choose the appropriate light pattern, and/or to change the light pattern based on results of the first-tried sheath's light pattern and/or the patient response obtained. [0017]In some embodiments, the invention provides a method that includes generating a first light beam from a first self-contained-energy-storage-powered (e.g., battery-powered) light-emitting source, generating a second light beam using a self-contained-energy-storage-powered (e.g., battery-powered) second light-emitting source, combining the first and second light beams, focusing the combined first and second laser light beams, and controlling an amplitude and/or timing of the first and/or second light beams. [0018]In some embodiments, the present invention includes an apparatus having a finger-and/or-thumb control that controls a characteristic of light, optics to focus and deliver the light to a nerve, a self-contained-energy-storage-powered (e.g., battery-powered) laser having a wavelength and power capable of efficaciously stimulating a nerve, and a controller operable to drive the laser based on input from the finger/thumb control. In some embodiments, this apparatus is used to deliver an efficacious amount of visible and infrared (IR) light so as to target and stimulate nerve tissue. In some embodiments, a visible laser beam is used to point to and illuminate the area to be stimulated and an IR laser beam is used to stimulate a nerve at that illuminated area. [0019]In some embodiments, the present invention includes an apparatus having an optical nerve stimulator, an energy-storage-device charger (e.g., battery charger), and a remote wireless controller and/or programmer. [0020]In some embodiments, the stimulation light is IR (infrared, e.g., about 1.8-micron wavelength), while in other embodiments other IR wavelengths, visible light wavelengths, ultraviolet wavelengths, and/or combinations of a plurality of such wavelengths are used. Continue reading about Apparatus and method for stimulation of nerves and automated control of surgical instruments... 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