Abstract: The present invention is directed to a cardiac lead for delivery to the left side of a patient's heart including a self-expanding fixation method positioned over the distal portion of the lead. The self-expanding fixation member is capable of automatically expanding from a collapsed state to an expanded state upon deployment at a target site in a cardiac vessel. The fixation member is configured such that in the expanded state it is biased to a side of the lead body.

Abstract: Tissue markers, systems for marking tissue, and methods of using tissue markers. A tissue marker may have a body with a first surface and a second surface, a plurality of coupling sites, and a plurality of elongate members. The tissue marker may include a remotely visible material. The tissue marker may have a delivery configuration that is different from a deployed configuration.

Abstract: The application relates to an apparatus for intraocular injection comprising a plate adapted for being brought into contact with an eye and guiding means for guiding a needle into the interior of an eye, characterized in that the plate comprises a cut-out having an edge adapted to be positioned along the limbus delimiting the cornea and the sclera of the eye, so as to adjust the position of the guiding means with respect to the limbus.

Abstract: A transdermal transport device includes a reservoir for holding a formulation of an active principle, a needle with a bore through which the formulation is transported between the reservoir and a target area of a biological body, and an impedance sensor. The impedance sensor has an electrode positioned to measure the impedance of a portion of the target area between the needle and the electrode to indicate the depth of penetration of the needle into the target area.

Abstract: A selectively lockable introducer assembly is disclosed that comprises an introducer cannula and a needle guide. The introducer cannula is defined by a proximal end and a distal end and includes a lumen extending therebetween. The needle guide is defined by a body portion that includes at least one channel extending therethrough. The introducer cannula is configured to be selectively receivable within the at least one channel and the introducer cannula may be selectively lockable with respect to the needle guide such that the introducer cannula is selectively prevented from moving laterally with respect to the needle guide.

Abstract: The self-injection guide tablet for subcutaneous injections includes adhesively mounted templates with headings indicating a particular day and body injection area. Each template further includes a grid guide, designed to cover the body injection area, along with instructions for placing the grid guide on the particular body injection area. Each grid guide includes a plurality of injection grids, in column or row format, with indicia marking a predetermined injection grid. Upon removing the grid guide from the specific template, the predetermined injection grid remains on the template, so the vacated injection grid forms the injection area for the subcutaneous injection.

Abstract: A regional anesthesia system and a cart for aiding in the placement of a regional anesthesia block without the need of ancillary assistance. The invention includes equipment for use in the performance of a regional anesthesia block which is carried on a cart for transporting and providing a stable foundation for the equipment. The equipment includes a nerve localization means such as ultrasound or a peripheral nerve stimulator for locating a target nerve of a patient, a position assist arm for maintaining the position of the localization means over the target nerve while the operator inserts an anesthetic needle over the target nerve, and an anesthetic infusion device for infusing or aspirating through the anesthesia needle. The infusion device includes an infusion pump controlled by a foot pedal. The system may be easily transported to a patient requiring a regional anesthesia block, and allows the regional anesthesia block to be performed with minimal ancillary assistance.

Abstract: Assemblies for identifying a power injectable vascular access port are described. One assembly includes a vascular access port, a first identifiable feature, a second identifiable feature, and a third identifiable feature. The first identifiable feature is incorporated into the access port and identifies the access port as suitable for flowing fluid at a fluid flow rate of at least about 1 milliliter per second through the access port. The second identifiable feature is incorporated into the access port and identifies the access port as suitable for accommodating a pressure within the cavity of at least about 35 psi. The third identifiable feature is separated from the access port and confirms that the implanted access port is both suitable for flowing fluid at a rate of at least about milliliter per second through the access port and for accommodating a pressure within the cavity of at least about 35 psi.

Abstract: A skin retention device 10 for a medical jet-injection unit 20 comprises a contact face provided with adhesive 12 in the area surrounding and close to the injection opening(s) 11 of the nozzle 21 which ensures god contact between the nozzle 21 and the skin 30 of a subject in the area chosen for an injection. Consequently the injection force can be lowered dramatically. In case of two-stage jet-injections, the initial injection force can be lowered because the skin retention close to the injection point significantly reduces the energy consuming elastic expansion of the skin 30 in the injection area, and the second injection force can be lowered because of the high degree of fixed positioning of the injection opening of the nozzle 21 relative to the injection channel in the skin 30 made during the initial injection stage. Thus a high degree of injection safety is achieved, minimizing the risk of whet shots, while skin lift and lower injection force decreases the risk of damage of the underlying tissue.

Abstract: An apparatus for inserting a marking element into a marker body includes a body portion, an insertion member, and a pushing member. The body portion has a compartment configured to receive a marker body. The insertion member is configured to engage the marker body within the compartment. The pushing member is configured to engage with the insertion member. The pushing member is operable to force a marking element along the insertion member into the marker body. The insertion member may include a hollow needle configured to penetrate the marker body. The pushing member may include a pin configured to fit within the hollow needle. The marker body may include an opening such as a slit, a slot, or a passage that is configured to receive a marking element. The marker body may include a collagen dowel, and the marking element may be formed of titanium.

Abstract: An access port for subcutaneous implantation is disclosed. Such an access port may comprise a body for capturing a septum for repeatedly inserting a needle into a cavity defined within the body. Further, the access port may include at least one feature structured and configured for identification of the access port subsequent to subcutaneous implantation. Methods of identifying a subcutaneously implanted access port are also disclosed. For example, a subcutaneously implanted access port may be provided and at least one feature of the subcutaneously implanted access port may be perceived. Further, the subcutaneously implanted access port may be identified in response to perceiving the at least one feature. In one embodiment, an identification feature is engraved or otherwise defined by the access port, so as to be visible after implantation via x-ray imaging technology.

Abstract: In various embodiments, a needle is employed in refilling drug-delivery devices.

Abstract: Devices, systems, and methods provide accurate and consistent identification of the center of a magnetic infusion port.

Abstract: The invention relates to a highly automated puncture system for inserting a cannula or a needle into a blood vessel of a person or an animal. The puncture system has an acquisition module that allows for determining at least a location of a blood vessel underneath of the surface of a skin and is further enabled to determine an optimal puncture location that is potentially suitable for inserting a cannula into the blood vessel. Further, the puncture system has tissue analysis means to analyse the skin surface in the proximity of the puncture location to check whether the skin is suitable for punctuation. This prevents puncturing the skin at locations where scars, wound and the like can be found.

Abstract: An implantable access port comprises a housing defining a fluid receiving chamber and a septum covering an opening of the housing to permit access to the fluid receiving chamber in combination with a light source coupled to the housing, the light source aimed so that, when the port is implanted subcutaneously in a desired orientation, light transmitted from the light source impinges on an area of skin adjacent to a location of the septum.

Abstract: To provide a chip for collecting analyte from a living body. Specifically, the chip includes a thin plate-shaped main body, an analyte inlet portion, and a thin portion. Analyte is introduced into the analyte inlet portion, which is formed within the main body. The thin portion partitions the space forming the analyte inlet portion from the external space. According to the chip of the present invention, it is possible to eliminate the time for collecting analyte from a living body using a hypodermic syringe or the like, and placing the collected analyte into the chip. Also, the chip according to the present invention does not leave analyte remaining at the position from which the analyte was extracted, so after the test the position where the analyte was extracted from the living body is clean.

Abstract: Many medical procedures, such as needle-sticking, could benefit from an assistive device that improves the optical contrast of externally targeted features and lumens of interest residing in and underneath the skin and/or exposed organ tissues. The inventive inexpensive device and method are useable on such externally targeted features and lumens while also protecting the practitioner and freeing up both of his/her hands, if necessary, to thereby eliminate practitioner self-sticking problems. The present device provides good optical contrast and also provides splash-protection against HIV, hepatitis and other blood-borne diseases. The inventive device method and apparatus may also include vibratory subcutaneous electrical nerve stimulation (TENS), drug-based or heating treatment capabilities for reducing pain, both perceived and real pain, associated with a device guided procedure. Finally, the pain reduction mechanisms have also been found useful for lumen dilation.

Abstract: A method of marking the boundaries of at least one vessel with a vessel access marking for locating a vessel puncture access site to facilitate the introduction or withdrawal of fluid from the vein in connection with a medical procedure, the method comprising the steps of: designating an anatomical portion of an individual on which the medical procedure is performed; locating a vessel along the anatomical portion of the individual; applying a marking material to designate the boundaries of the vein, the marking material defining a region for vessel puncture access; cleansing an area proximate the vessel access marking and accessing the region of vessel puncture access using the vessel access marking as a visual reference.

Abstract: An elastically deformable marker (1) which can be completely implanted by means of a cannula for marking a tissue site, wherein the marker assumes a relaxed condition without an external force acting thereon and has at least one flexurally elastic wire, an elongate central marker portion and a proximal and a distal end portion, wherein a respective one of the two end portions is disposed at one of the two ends of the central marker portion, wherein in the elongate central marker portion at least two portions of the same flexurally elastic wire or a plurality of flexurally elastic wires are twisted together.

Abstract: Apparatuses and methods for performing and aiding venipuncture. The apparatuses of the present invention provide the medical practitioner with an improved tool for performing venipuncture methods. The apparatus preferably includes a handle that is connected to a plurality of tines that run roughly parallel to one another. During use, the tines of the apparatus are pressed against the skin of the patient such that they sit astride the vein to be accessed. The distance between the various tines of the present apparatuses varies so as to be able to accommodate a variety of vein widths. The apparatuses of the present invention may have tines at either one or both ends of the body of the apparatus. The apparatuses of the present invention may be used with a variety of vein accentuating devices, such as those that employ light to accentuate the vein to be punctured.

Abstract: A system for relieving pain caused by a tumor within a body may include an injection system having an injector configured to inject an anesthetic within the body to relieve the pain caused by the tumor, and a robotic system configured to position the injector at a plurality of specified, spaced-apart injection locations within the body. A method of relieving pain caused by a tumor within a body may include: generating an image of the tumor within the body; identifying, based on the image, a plurality of locations within the body at which an injection of an anesthetic that relieves the pain caused by the tumor should be made; and making injections of the anesthetic at the locations, under the control of a robotic system that is programmed to make the injections at the identified locations without human intervention between the injections.

Abstract: A system for delivering a prenatal medication to an unborn fetus within a body may include an injection system having an injector configured to inject the prenatal medication into or in the vicinity of the fetus, and a robotic system configured to position the injector at one or more injection locations within the body. A method of delivering a prenatal medication to an unborn fetus within a body may include generating an image of the fetus within the body; identifying, based on the image, one or more locations within the body at which an injection of the prenatal medication should be made; and making injections into the fetus of the prenatal medication at the locations, under the control of a robotic system that is programmed to make the injections at the identified locations without human intervention between the injections.

Abstract: A method of securing a biopsy marker within a biopsy site includes depositing a marker element within a biopsy site and fixing the marker element within the biopsy site by injecting a securing agent within the biopsy site. Delivery devices for delivering the securing agent to the biopsy site are also disclosed.

Abstract: A cannula system and corresponding method for locating a tip of an elongate member (e.g., a catheter or other therapy delivery device) in a three-dimensional space such as a cranial cavity. One embodiment of the invention may utilize a secondary or device placement cannula that fits within a primary or guide cannula. The device placement cannula may have a length that is indexed relative to a length of a mapping member.

Abstract: The present invention provides a highly automated puncture system for inserting a cannula or a needle into a blood vessel of a person or an animal. The puncture system has an acquisition module that allows for determining at least a location of a blood vessel underneath of the surface of a skin and is further enabled to determine an optimal puncture location that is well suitable for inserting a cannula into the blood vessel. Further, the puncture system has an actuator for moving and aligning the cannula to a determined position. The system is further adapted to autonomously insert the cannula into the blood vessel for multiple purposes, such as blood withdrawal, venous medication and infusions.

Abstract: The present disclosure is directed to a device for locating a fistula. The device can include a first tine and a second tine each having a distal end and a proximal end with the first tine spaced a distance from the second tine sufficient for allowing a section of a fistula to fit therebetween. A compression member can be placed adjacent to the first tine and the second tine such that the compression member externally compresses and temporarily occludes a fistula thereby increasing blood pressure in a section of a fistula located between the first tine and the second tine.

Abstract: A template, to be provided at some distance from the skin, provided with multiple guide holes for needles or catheters of which one or more can anchor in the prostate. The template is provided with a locking mechanism so that, after placement, the anchored needles keep all needles in their original places. The above-described method of fixedly positioning a treatment template prevents the needles from moving due to swelling of the tissue in the prostate, which causes the irradiation source, which is later provided in the needles, to improperly irradiate the area.

Abstract: A handheld instrument for minimizing pain during administration by injection of a liquid, such as, an anesthetic that has a main body, a vibration unit mounted in the main body when initiated to cause the main body to vibrate, and a detachable tip cantilever mounted on the main body to vibrate with it, the tip having a free end characterized by a bifurcation to form two spaced projections defining a space between them, whereby the spaced projections can be placed in proximity to, adjacent to and bracketing a preselected injection site on a human or animal and the tissue at said preselected injection site and vibrated while an injection is given.

Abstract: A vein locator comprises an energy source for directing incident energy toward organism tissue. At least a portion of the incident energy is reflected from structures within the organism tissue as reflected energy. The vein locator comprises an energy detector connected to detect energy reflected from the organism tissue. The incident energy is moved across a scan region a first time and the energy detector produces a corresponding first signal representative of at least one characteristic of the first reflected energy. A controller receives the first signal, identifies an extremum in the first signal and determines a threshold level based on the identified extremum. The incident energy is then moved across the scan region a second time and the energy detector produces a corresponding second signal representative of at least one characteristic of the second reflected energy.

Abstract: A positioning system for percutaneous interventions, which is useful with clinical operating procedures and permits rapid and precise insertion of a needle or other medical instrument into a patient's body. Positioning is accomplished by using a combination of navigation software and a reference frame and needle or instrument holder.

Abstract: The invention relates to a system for guiding a probe over the surface of the skin of a patient. Performing measurements with ultrasound techniques for small structures such as blood vessels need well-defined spatial relationship between the measuring probe and the tissue which has to be examined. The invention seeks to ensure a movement of the measuring probe in a controlled and precise way over the skin. Therefore, a system 1 is suggested which comprises a probe holder 2 to which a probe 4 is rigidly attachable. The probe holder 2 is moveable along at least one rail 5, 5?. The rail can be wrapped around the patient 3 or a body part 7 of the patient or the animal.

Abstract: This invention relates to an injection site or gateway or a system comprising such an injection site or gateway. In one form the invention concerns a system comprising an inserter device and a gateway for subcutaneous injection of fluid where comprises a distal surface (1a) corresponding to a proximal surface (1b) integrated with the inserter device. In another form the invention concerns a gateway for subcutaneous injection of fluid, which gateway comprises—a body (1) with at least one through-going opening (6) with an entrance and an outlet, and at least one cannula (3) and having a proximal end protruding from the lower side of the body; —and at the entrance of the through-going opening medication can be injected by a delivery device (20) which delivery device has protruding parts (22) which form an inner opening with a diameter di; wherein the surface of the entrance is shaped in such a way that the cross-section of the top part of entrance, i.e.

Abstract: Disclosed are method and apparatus for guiding a needle during an interventional radiology procedure. The target and skin entry point are pre-determined in three-dimensional medical imaging scans. The needle trajectory is defined by the target and skin entry point, which is physically marked on the skin. A dual-headed laser emitting two laser beams is positioned and aligned such that one laser beam is aimed at the skin entry point and the other laser beam is aimed at an external reference point, which is determined such that the axis of the laser beam aimed at the skin entry point is substantially collinear with the needle trajectory. The needle is inserted while maintaining the axis of the needle substantially collinear with the axis of the laser beam aimed at the skin entry point.

Abstract: The present application relates to a puncture system for inserting a cannula or a needle into a blood vessel of a person or an animal. The puncture system (100) has location determination means (108) for determining at least one location of the blood vessel. The location determination means are mechanically flexible such that their shape is adaptable to the shape of a body part of the person or animal. Furthermore, the system comprises processing means (112) for determining a puncture location (124) of the blood vessel depending on the output of the location determination means.

Abstract: Intranasal delivery devices include dosage forms containing medical compositions for use in the intranasal devices, and methods of delivering medical compositions to the nasal mucosa of users. The devices dispense a predetermined quantity of fluid into the nasal passage of a user, in which the predetermined quantity of fluid is contained in, or produced in a dosage form or blister that is crushed by a plunger with sufficient force to drive the dosage form against a piercing mechanism, piercing the dosage form and forcing the liquid contents from the dosage form and through a delivery channel into a spray to be directed into the nasal passage of a user. The plunger is connected to a trigger device by a linkage that confers a mechanical advantage to the trigger mechanism.

Abstract: The invention is directed to lesion site marking devices and methods. Specifically, the device of this invention typically is made up of a filler body comprising a bioremodelable material comprising an extracellular matrix (ECM) material, such as small intestine submucosa (SIS) and a detectable marker associated with the filler body and adapted to mark a center of the filler body. The device of this invention may also be made up of a filler body comprising a biocompatible polymer, such as THORALON, and a detectable marker associated with the filler body and adapted to mark a center of the filler body.

Abstract: Apparatus and method for assisting in choosing a suitable site for a skin invasive action, such as drug injection, e.g. insulin for persons with diabetes, or collecting blood or tissue samples. Measures and processes parameters relating to a specific area part of the skin or subcutis and determines whether the area part is suitable for the skin invasive action based on the processed parameters. Suitable for assisting a person in choosing a site during an injection/sampling procedure, ensuring that skin invasive actions are performed at suitable sites only. Very useful for repetitive skin invasive actions, such as BG measurements and insulin injections. Helps in varying sites for the skin invasive action without the need for keeping a record of used sites manually. Helps in avoiding tissue infiltrations and lipodystrophy.

Abstract: A therapy delivery system for the intermittent delivery of biologics, chemicals, or pharmaceuticals into tissues is described. The system involves a chronically implantable guide tube having a guide cannula with a proximal and a distal end, an access port mounted on the proximal end of the guide cannula and adapted for chronic implantation into a patient, a first stop mounted near the distal end of the guide cannula and a delivery cannula insertable into the lumen of the guide cannula through the access port. The delivery cannula mechanically interacts with the first stop and is designed to prevent the delivery cannula from extending beyond a predetermined distance from the distal end of the guide cannula. A tissue-piercing tip may be attached to the distal end of the delivery cannula to penetrate tissue growth near the target site. A stylet may be used to occupy the lumen of the guide cannula when the delivery cannula is not in use.

Abstract: A device for positioning a bore needle into a specific position within a vein includes a first body defining proximal and distal ends. A first needle extends from the distal end, establishing fluid communication through the first body from the distal to the proximal end. A second body co-axially supports the bore needle for rotational orientation in the specific position, and has a distal end with an aperture that defines an angle relative to the longitudinal axis of the bore needle. The first and second bodies are respectively mounted to first and second opposed sides of a web body that defines an angle between the first needle and the bore needle when the bore needle is received in the second body, for positioning the aperture of the bore needle in the specific position in alignment with the first needle and opening substantially in the longitudinal direction of the first needle.

Abstract: A device and method for determining at least one infusion and/or injection region for infusing and/or injecting a medical drug into a heterogeneous body structure in order to achieve a distribution of the medical drug in a desired target region of the heterogeneous body structure is provided. The device and method provide at least one property of the heterogeneous body structure that influences the spatial distribution of the medical drug in the heterogeneous body structure; and determine the at least one infusion and/or injection region from which the medical drug is to be transported through the heterogeneous body structure to the at least one target region as a function of the at least one property of the heterogeneous body structure and a position of the desired target region.

Abstract: Medical devices can be positioned within a patient by use of apparatus and methods according to the invention. The apparatus and methods permit insertion of the medical devices into various locations of the patient's body without requiring removal and reinsertion of already-inserted medical devices. The apparatus and methods are typically used to place medical devices into a male patient's urinary system to treat a disease or condition. The medical devices can be cryoablation probes that are inserted into the prostate gland to treat prostate cancer, for example.

Abstract: The present invention relates to apparatus for use in neurosurgery, and to a method of positioning neurosurgical apparatus. The stereoguide comprises first and second guide elements through which instruments are passed along an axis of insertion towards a target and a first clamp (25) having a clamping position on the axis between the guide elements and the target.

Abstract: In a biopsy system having a biopsy needle guide secured to a needle guide support bracket, a biopsy needle guide is provided that includes a body having a periphery that defines an edge of the needle guide, the periphery defining a top surface, a bottom surface and a pair of side surfaces. A cradling aperture is positioned in the body and sized to engage the needle guide support bracket. A channel is provided in communication with the cradling aperture. The channel extends inwardly from one of the side surfaces of the body toward the cradling aperture. The needle guide of the present invention inhibits movement of the needle guide relative to the support bracket during a biopsy procedure.

Abstract: An anchored fiducial apparatus is described. The fiducial apparatus anchors itself in the target region once inserted so that the fiducial apparatus does not move relative to the target region.

Abstract: A kit that facilitates performance of a tracheostomy in emergency situations remote from an operating room. The kit includes a template guide for placement on a person on which the tracheostomy is to be performed to indicate the desired incision location, a cutting instrument configured for making an incision of a desired depth, and a breathing tube for placement into the incision.

Abstract: A locator device precisely identifies a predetermined spot which is hidden by a skin. The device is an outer washer and an inner washer with both washers being magnetized. The inner washer is positioned underneath the skin to mark the location of the predetermined spot therein. The outer washer aligns with the inner washer when proximate thereto to thereby locate said predetermined spot.

Abstract: The present invention is directed to a method and apparatus for positioning and creating an opening in a person's shirt or blouse at a location that varies depending on the underlying location necessary to perform a medical procedure. The created opening allows access to a porta-cath without requiring the patient to remove his/her shirt/blouse.

Abstract: A needle or puncture guard that has inherent probe directing features for use in an in-line configured shunt valve is provided. The guard comprises a base member configured for mounting within the domed reservoir of the shunt valve, and a guide wall seated on the base member. The guide wall is defined by a top wall, an inner side wall, and an opposed outer side wall. The inner side wall has an indented section with an aperture extending through the indented section. The inner side wall can be concavely curved, while the indented section has a curvature that directs instruments that are pressed against the guide wall towards the aperture. A method for performing catheter revisions on a shunt system having a guard within the shunt valve is provided as well. Also provided is a method for placement of an intracranial pressure sensor percutaneously into a ventricular catheter for determining intracranial pressure.

Abstract: An apparatus for delivering subcutaneous cavity marking devices. More particularly, the delivery devices may be used with biopsy systems permitting efficient placement of a biopsy marker within a cavity. The device may include an intermediate member which assists in deployment of the marking device. The devices may also include a deployment lock to prevent premature deployment of a biopsy marker. The invention may further include the capability to match an orientation of a biopsy probe which has been rotated upon procurement of a biopsy sample.

Abstract: Systems and methods are disclosed for identifying and deploying a protective cover about a percutaneous puncture site formed by a hypodermic needle. In the preferred embodiment, a marking agent or puncture site covering, the latter of which preferably takes the form of a bandage, is releasably secured upon either the needle hub of the hypodermic needle or on a sliding member or sleeve axially moveable along the length of said needle that forms a marking or detaches therefrom once compressed about the puncture site.

Abstract: A hollow fiber with a plurality of members projecting from its outer surface in an arc turned back on itself is formed from a spinneret having a segmented orifice wherein each segment comprises a first portion in the form of an arc curved about the center of the orifice, a second portion extending from the first and connected to a third portion which is in the form of a reverse curve with respect to the first.