Showing papers in "Official Gazette of the United States Patent and Trademark Office Patents in 1995"

Medical diagnosis, treatment and imaging systems

Abstract: A locating system for determining the location and orientation of an invasive medical instrument, for example a catheter (10) or endoscope, relative to a reference frame, comprising: a plurality of field generators (18, 20, 22) which generate known, distinguishable fields, preferably continuous AC magnetic fields, in response to drive signals; a plurality of sensors (30, 32, 34) situated in the invasive medical instrument (10) proximate the distal end thereof which generate sensor signals in response to said fields; and a signal processor (26) which has an input for a plurality of signals corresponding to said drive signals and said sensor signals and which produces the three location coordinates and three orientation coordinates of a point on the invasive medical instrument.

Angioplasty apparatus facilitating rapid exchanges

Abstract: Apparatus for introduction into the vessel of a patient comprising a guiding catheter adapted to be inserted into the vessel of the patient and a device adapted to be inserted into the guiding catheter. The device includes a flexible elongate member and a sleeve carried by the flexible elongate member near the distal extremity thereof and extending from a region near the distal extremity to a region spaced from the distal extremity of the flexible elongate element. The device also includes a guide wire adapted to extend through the sleeve so that the guide wire extends rearwardly of the sleeve extending alongside of and exteriorally of the flexible elongate element into a region near the proximal extremity of the flexible elongate element.

Intralumenal drug eluting prosthesis

Abstract: A prosthesis for insertion into a lumen to limit restenosis of the lumen. The prosthesis carries restenosis-limiting drugs which elute after the device is positioned in the lumen.

Oligonucleotides containing N-2 substituted purines

Abstract: This invention presents novel purine-based compounds for inclusion into oligonucleotides. The compounds of the invention, when incorporated into oligonucleotides are especially useful as "antisense" agents--agents that are capable of specific hybridization with a nucleotide sequence of an RNA. Oligonucleotides are used for a variety of therapeutic and diagnostic purposes, such as treating diseases, regulating gene expression in experimental systems, assaying for RNA and for RNA products through the employment of antisense interactions with such RNA, diagnosing diseases, modulating the production of proteins, and cleaving RNA in site specific fashions. The compounds of the invention include novel heterocyclic bases, nucleosides, and nucleotides. When incorporated into oligonucleotides, the compounds of the invention can be useful for modulating the activity of RNA.

A flexible expandable stent

Abstract: There is disclosed a stent for implanting in the body. The stent is formed of a tube having a patterned shape which has first and second meander patterns having axes extending in first and second directions. The first meander patterns can be formed into even and odd first meander patterns. The even and odd first meander patterns are 180° out of phase with each other and the odd patterns occur between every two even patterns. The second meander patterns are intertwined with the first meander patterns. The first and second directions can be orthogonal to each other. The second meander patterns can also be formed of even and odd patterns.

Method for the preparation of substantiallly monomeric calicheamicin derivative/carrier conjugates

Abstract: A method is provided for preparing monomeric calicheamicin derivative/carrier conjugates with higher drug loading/yield and decreased aggregation. These conjugates are prepared by incubating a calicheamicin derivative and a proteinaceous carrier in a solution comprising a phosphate buffered solution, a cosolvent comprising propylene glycol, an additive comprising at least one C6 -C25 carboxylic acid, preferably having a pH in the range from about 7.0 to 8.5, and at a temperature ranging from about 25° C. to about 37° C. for a period of time ranging from about 2 hours to about 18 hours, and recovering monomeric calicheamicin derivative/carrier conjugates. Alternatively, the conjugates can be prepared by incubating the calicheamicin derivative and a proteinaceous carrier in a solution comprising a phosphate buffered solution and a cosolvent comprising t-butanol.

System and method for electrosurgical tissue canalization

Abstract: A method for transmyocardial revascularization of the heart of a patient comprises introducing a probe (10) into the thoracic cavity through a percutaneous penetration, a thoracotomy or a sternotomy. An active electrode surface (58) is then positioned adjacent a wall of the patient's heart, e.g., the ventricular wall. Electrically conducting liquid (50) is directed to the heart wall to provide a current flow path and high frequency voltage is applied to ablate or disintegrate tissue at the heart wall. The probe is then axially translated towards the ventricular wall to form a revascularizing channel or artificial vessel from the ventricle to the myocardium to increase blood flow therethrough.

Thromboresistant surface treatment for biomaterials

Abstract: A biomaterial with a thromboresistant surface and a method for forming same are provided. The thromboresistant surface is comprised of a distinct coating layer of a chitosan-based membrane and a bioactive material. The bioactive material is capable of converting the chitosan membrane coating from a highly thrombogenic to an essentially non-thrombogenic one. The bioactive material can be a polymeric substance, such as polyvinyl alcohol, forming a polymeric blend with the chitosan, or, can be a biological substance, such as serum albumin, embedded in or attached to the chitosan membrane which has been activated with a treatment of glutardialdehyde. The thromboresistant biomaterial is suitable for use in vascular grafts having an inside diameter of less than 6 millimeters.

Bidirectional suture anchor

Abstract: A cannulated bone screw for anchoring bidirectional suture threads to bone is provided, comprising a biocompatible body having a proximal end and a distal end, the body including exterior screw threads, preferably self-tapping, for inserting and retaining the body into the bone; a passageway extending through the body, the passageway including a central portion, a proximal portion, and preferably a distal portion, the central portion being sized to receive a suture thread therethrough, the proximal and distal portions each being sized to receive a suture thread knot, the central portion being sized smaller than the proximal and distal portions, the central portion being sufficiently small as to prevent a suture thread knot from being drawn therethrough; and a drive socket, formed into the proximal end of the body, the drive socket being sized to prevent a drive tool from contacting a suture thread knot within the proximal portion of the passageway. The body of the bone screw may be either cylindrical in shape, or it may be tapered with variably pitched screw threads. The bone screw is constructed of a biocompatible material, such as a metal, a non-absorbable polymer, or a bioabsorbable material, where the biocompatible material is coated with a bioabsorbable coating having a low coefficient of friction. The bioabsorbable coating may include one or more compounds, such as a pharmaceutical or selected bone growth factors. A method for using the bidirectional bone screw is also provided.

Pharmaceutical nanosuspensions for medicament administration as systems with increased saturation solubility and speed of dissolution

Abstract: Systems with a strongly increased saturation solubility (Cs) are obtained by preparing nanosuspensions of medicaments. The saturation solubility of medicaments with low bioavailability may thus be increased. This additional increase of the saturation solubility increases the speed of dissolution beyond what can be achieved by simply enlarging the surface of the medicament. Extremely stable nanosuspensions are obtained by using very low surfactant and stabiliser concentrations. Surfactant-free nanosuspensions may be prepared. Large-scale production of nanosuspensions with a very low content of micrometric particles is made possible by cavitation, with its accompanying advantages. The preparation of nanosuspensions by cavitation was thought to be impossible because the powdered medicament particles were expected to block the more or less 25 νm wide gap. Alternatively, the nanosuspensions may be prepared by shearing or impact in flow dispersion machines while respecting the above principles of optimum stabilisation or surfactant-free preparation.

System and method for ambulatory monitoring and programming of an implantable medical device

Abstract: A system and method for ambulatory monitoring and programming of an implantable medical device are provided. The system enables ambulatory communication between a modified programmer/analyzer and an implantable medical device having telemetric communication capability. This is accomplished through the use of an ambulatory interface unit which may be conveniently attached to the patient's body using a belt or harness. The ambulatory interface unit wirelessly communicates with both the programmer/analyzer and the implantable medical device thereby providing for improved patient mobility. The ambulatory interface unit may include an integral telemetry head or may be connected to the telemetry head by a communication cable.

System for infusion of medicine into the body of a patient

Abstract: A system for infusing medicine into the body of a patient includes an implantable infusion apparatus containing a dosing unit with a reservoir for the medicine and a medicine delivery pump for pumping doses of the medicine from the reservoir into the patient. The infusion apparatus also includes a sensor for sensing a parameter of the patient for controlling the dosing of medicine according to the sensed parameter. The dosing unit and the sensor are galvanically separable and are each provided with separate telemetry communication units for communication with an external programmer/controller. The external programmer/controller includes telemetry communication units for selectable communication with the dosing unit or the sensor or both simultaneously. The telemetry communication units of the external programmer/controller, the dosing unit and the sensor are constructed for bi-directional communication between the external controller and each one of the dosing unit and the sensor.

Method for the manufacture of pharmaceutical cellulose capsules

Abstract: A method and apparatus for manufacturing pharmaceutical capsules use an aqueous solution of a thermogelling cellulose ether composition and use capsule body pins and capsule cap pins as molds. The method involves heating the pins, dipping the pins into the solution to cause the solution to gelatinize on the surface of the pins, removing the pins and drying the gelatinized solution on the surface of the pins to form capsule bodies and capsule caps. Pins are heated pre-dip and post-dip to facilitate gelating. Counterflow air is applied to provide drying from the inside. Capsule parts are removed by gripping. Capsule parts may have a thick wall and a stiffening ring.

Method of and apparatus for making a dental set-up model

Abstract: A method of and an apparatus for making a dental set-up model utilizable in the practice of orthodontics and, more particularly, to facilitation of making the dental set-up model. The shape of an impression which is a replica of dental teeth and dental alveolar ridges of a patient is first converted on a non-contact basis into electronic data by means of a three-dimensional profile analyzer utilizing an irradiation beam. Using this electronic data and within the framework of such electronic data, representative plane defined by anatomically proximal contact points A1, anatomically distal contact points A2 and an intermediate point E between the bucco-cervical point B1 and the lingo-cervical point B2 are formed by cutting out the individual teeth. Subsequently, for each tooth, a DI line, which is a straight line connecting between the bucco-cervical point B1 and a representative point C of a cusp or edge that has been projected onto the representative plane, and a DH line intersecting the DI line perpendicularly at a point spaced a predetermined distance from the representative point C towards the dental alveolar ridge are formed. Then, the DH lines for the respective teeth are arranged on a plane along a guide line descriptive of an ideal individual dental arch form and respective heights of the DH lines for all teeth which have been lined up to a predetermined height are adjusted to a predetermined level, followed by adjustment of the angle of inclination of the representative plane for each tooth relative to a facial reference line set up on the face.

System and method to monitor the heart of a patient

Abstract: A system and method for monitoring a physiological attribute of a patient is disclosed. The system includes a measuring device to measure an absolute physiological attribute of a patient and to generate an absolute physiological attribute signal. The present invention also includes a processing element to receive the measured absolute physiological attribute signal. The processing element then generates a filtered physiological attribute signal by substantially removing the effects of certain bodily functions from the absolute physiological attribute signal and other artifacts of measurement. The processor also generates a set of parameters derived from the filtered physiological attribute signal which are indicative of the health and condition of the patient.

Method of applying a surgical ligation clip

Abstract: A surgical ligation clip is preformed from a continuous piece of metal wire to assume a shape having a reduced cross-sectional area. A clamping arm of the clip is alternately moveable from a clamped to an unclamped position above a vessel support member. A tension coil joins the vessel support member to the clamping arm and provides the hemostatic clamping force from the clip to the targeted blood vessel.

Thermal mapping catheter with ultrasound probe

Abstract: A medical probe apparatus comprising a catheter (10) having a stylet guide housing with one or more stylet ports therein and stylet guides for directing one or more flexible stylets outward through intervening tissue to target tissue. The active stylets emit radio frequency RF energy which establishes an RF current in the patient. The current, being densest at the stylet tips, causes heating of the surrounding tissue to initiate ablation of the target tissue. One aspect of the invention includes temperature sensing stylets at the location of the RF emitting stylets to monitor the temperature of the tissue being ablated. This allows the surgeon to have increased knowledge about the ablating action under way in order to control the intensity of the applied RF current, or to adjust the amount of time the current is applied, or both.

Space holder, in particular for a vertebra or an intervertebral disk

Abstract: A space holder in particular for a vertebra or an intervertebral disk is provided. The space holder comprises a jacket (1) having apertures (9, 10) and a first and second edge (7, 8). The edge has circumferentially adjacent recesses (9, 10; 9', 10') each extending in direction towards the other edge and a stop provided at at least one of the edges spaced from the outer edge. In order to provide for an easy manufacture and operation of the space holder the stop is formed by a member (11, 13, 16, 22) having an outer contour corresponding to the inner contour of the jacket (1) and nose-like projections (15) for engaging the recesses (9, 10) are provided at those locations of the periphery of the stop which correspond to the recesses (9, 10; 9', 10').

Plastic orthodontic appliance having a mechanical bonding base and method of making same

Abstract: This invention is directed to a plastic orthodontic appliance having projections extending outwardly from a bonding base. The projections include broadened outer extremities and undercuts proximate the outer extremities which form mechanical bonds with a bonding adhesive. The projections have peened free ends that form the undercuts, preferably with minute fractures therein extending into the outer extremities of the projections. In one application, a plurality of appliances in the form of slotted brackets is provided for cooperating with an archwire to apply corrective forces to a patient's teeth on which the brackets are mounted. Another aspect of the invention concerns a method of making plastic orthodontic appliances suitable for mechanical bonding. The method includes molding a plastic orthodontic appliance having projections with undeformed outer ends or tips and subsequently bombarding the tips of the projections with particles impinged thereon, for example as by peening, to widen the outer extremities of the projections to form the undercuts. In the preferred embodiment of the method, ANSI no. 2 glass beads are fluidized and blown in an air stream onto the tips of the projections to widen and fracture the end regions of the projections, providing the surface with a characteristically peened texture, preferably one that includes fractures into the end regions.

Method for treatment of sleep apnea by electrical stimulation

Abstract: A method for opening an upper airway of a patient by applying electrical stimulation to the patient's hypoglossal nerve includes positioning of an electrode into electrical contact with a selected portion of the patient's hypoglossal nerve, applying a stimulating electrical current from the electrode to the hypoglossal nerve and intraoperatively verifying the position of the electrode or adjusting the position of the electrode until it can be seen that the correct muscles of the upper airway are being stimulated. In particular, in an intraoperative setting it is possible to determine whether the correct muscles are being stimulated by looking for forward and contralateral extension of the patient's tongue or an increase in volume of the patient's oropharynx.

Methods and devices for hemogeneous nucleic acid amplification and detector

Abstract: This invention relates to improved methods for nucleic acid detection using methods such as the polymerase chain reaction (PCR). More specifically, the invention provides methods for simultaneous amplification and detection to enhance the speed and accuracy of prior methods. The methods involve the introduction of detectable DNA binding agents into the amplification reaction, which agents produce a detectable signal that is enhanced upon binding double-stranded DNA. In a preferred embodiment, the binding agent is a fluorescent dye. The methods also provide means for monitoring the increase in product DNA during an amplification reaction.

Method of DNA sequencing employing a mixed DNA-polymer chain probe

Abstract: Method and composition for detecting one or more selected polynucleotide regions in a target polynucleotide. In the method, a mixture of sequence-specific probes are reacted with the target polynucleotide under hybridization conditions, and the hybridized probes are treated to selectively modify those probes which are bound to the target polynucleotide in a base-specific manner. The resulting labeled probes include a polymer chain which imparts to each different-sequence probe, a distinctive ratio of charge/translational frictional drag, and a detectable label. The labeled probes are fractionated by electrophoresis in a non-sieving matrix, and the presence of one or more selected sequences in the target polynucleotide are detected according to the observed electrophoretic migration rates of the labeled probes in a non-sieving medium.

Method of assay

Abstract: A method for the flow cytometric assay of an analyte using monodisperse particles carrying a specific binding partner, the analyte and binding partner being selected from the group consisting of (a) antigen and specific antibody, (b) hormone and hormone receptor, (c) hapten and antihapten, (d) polynucleotide and polynucleotide binding protein, (e) biotin and avidin or streptavidin, (f) enzyme and enzyme cofactor and (g) lectin and specific carbohydrate, and the method comprising the steps of adding to the aqueous sample a predetermined amount of particles and a predeterminded amount of a labelled ligand having affinity for the analyte or the binding partner and detecting and quantifying the resulting labelled ligand-carrying particles by a flow cytometer, the method using a pair of different particle types which are distinguishable from each other by the flow cytometer and which respectively carry binding partners having the same specificity but different binding affinity for the analyte and independently but simultaneously detecting the two types of labelled ligand-carrying particles by the flow cytometer.

Methods and compositions for the dry powder formulation of interferons

Abstract: According to the present invention, methods and compositions are provided for spray-dried, interferon-based dry powder compositions, particularly interferon-beta. The compositions are useful for treating conditions in humans that are responsive to treatment with interferons. In particular, the methods of the present invention rely on spray drying to produce stable, high-potency dry powder formulations of interferons, including but not limited to IFN-beta. Surprisingly, it has been found that IFN can be prepared in high potency, dry powder formulations by spray drying. Such dry powder formulations find particular utility in the pulmonary delivery of IFN.

Bus system for interconnecting an implantable medical device with a plurality of sensors

Abstract: A two-conductor bus system is provided to electrically interconnect a plurality of physiologic sensors to a pacemaker, each sensor being adapted for placement along a pacing lead. The conductors of the bus extend longitudinally through the insulating material of the lead, connecting to each sensor. The pacemaker provides a supply voltage on the bus to provide power to the sensors. The sensors modulate the supply voltage on the bus to transmit information to the pacemaker. This information may be used by the pacemaker to adaptively pace the heart. In one embodiment, the sensors include bus monitoring circuitry for receiving control signals from the pacemaker.

Method for tubal electroligation

Abstract: A minimally-invasive surgery apparatus for causing the lumen of a vein to collapse to prevent blood flow through the vein, e.g., a varicose vein or a side branch of the saphenous vein, includes an electrode which is electrically connected to a power source, and the electrode is percutaneously advanced into the vein. Then, the power source is activated to energize the electrode and thus the blood vein until the blood vein sufficiently collapses to block the lumen of the vein. A feedback loop is also provided for sensing electrical impedance of the tissue within the vein being energized and for deenergizing the electrode when the impedance reaches a predetermined value. The apparatus can also be used to block a fallopian tube.

Detection of abnormal and induction of normal heart rate variability

Abstract: A microprocessor (300) with a date and time clock gathers time interval data (80, 86). The duration of time intervals in an electrocardiogram, or pulses are recorded. Stress data accumulated for the user are down loaded to a PC (301). The battery power pack (303) supplies electricity to operate the components (80 - 318). The user's stress status is displayed on a liquid crystal diode (302), and the voice microprocessor (318) broadcasts from a micro-speaker CPR instructions. If the battery (303) has less than a 20 % charge, a buzzer (304) notifies the user.

Treatment of vascular injury using vascular endothelial growth factor

Abstract: The present invention provides a method for inducing reendothelialization of the lining of an injured blood vessel comprising contacting the injured portion of the vessel with nucleic acid encoding an endothelial cell mitogen such as vascular endothelial growth factor (VEGF) operably linked to a promoter to result in expression of the mitogen when delivered to the cells at the site of vascular injury. The resulting reendothelialization of the injured blood vessel inhibits smooth muscle cell proliferation and consequently reduces restenosis. The methods of the present invention may be used to treat any blood vessel injury that results in denuding of the endothelial lining of the vessel wall, including, for example, those injuries resulting from balloon angioplasty and deployment of endovascular stents.

Method for treatment of skin lesions associated with cutaneous cell-proliferative disorders

Abstract: The invention is a method for treatment of cutaneous cell-proliferative disorders. More specifically, the method of the invention is useful in mitigating and inducing remission of lesions associated with such disorders and in controlling related symptoms of the disorders (such as scaling and itching). According to the method of the invention, an invertebrate neurotoxin is administered to the skin of the host at or near the site of a lesion. The preferred neurotoxin for use in the method of the invention is Botulinum toxin, particularly Botulinum toxin A.

Method and apparatus for discriminating between valid and artifactual pulse waveforms in pulse oximetry

Abstract: A method and apparatus for use in pulse oximetry for discriminating between valid pulse waveforms and artifactual pulse waveforms. Systolic upstroke times for valid pulse waveforms are in a consistent, narrow range which varies only slightly from subject to subject. This narrow range, which may be defined empirically for each subject or established by a default setting applicable to all subjects, defines a predetermined range of systolic upstroke times indicative of valid pulse waveforms. The systolic upstroke time of each pulse waveform is compared against the predetermined range, and pulse waveforms are deemed valid only if their systolic upstroke times are within the predetermined range. Only arterial oxygen saturation levels based on validated pulse waveforms are accepted. The present invention may also be used to validate the heart rate and/or R-R, intervals of an ECG, and for discriminating between sleep and wakefulness in a monitored subject.