Abstract: A vascular prosthesis is constructed from a structure having interconnected, helically oriented channel-porosity to allow oriented ingrowth of connective tissue into a wall of the prosthesis. The prosthesis can have a small internal diameter of 6 mm or less. Several different methods can be used to produce the prosthesis, including a fiber winding and extraction technique, a melt extrusion technique, and a particle and fiber extraction technique using either a layered method or a continuous method. Furthermore, mechanical properties of prosthesis are matched with mechanical properties of the host vessel, thereby overcoming problems of compliance mismatch.

Abstract: The disclosure is directed to techniques for delivering electrical stimulation therapy to support obesity management. The electrical stimulation therapy is configured to cause at least partial gastric distention. Gastric distention tends to induce a sensation of fullness and thereby discourages excessive food intake by the patient. The electrical stimulation therapy may be delivered to the gastrointestinal tract of the patient by electrodes deployed by one or more implantable leads coupled to an electrical stimulator. The electrical stimulator delivers stimulation pulses having a pulse width in a range found to be effective in causing gastric distention.

Abstract: Techniques are described that allow an implantable device to sense gastric data and activity data from a patient, and estimate the patient's amount of energy consumed and energy expended based on the sensed data. A system provides feedback to the patient, a family member, or a doctor about the patient's energy consumed, energy expended, and net energy. The data may be provided in table or graphical format, and may show daily or weekly energy balance data or may show a trend of the daily or weekly energy data. The patient may receive feedback by an implanted alert module that provides and audio alert or a vibration alert. In addition, data acquired by the system may be used to adjust the patient's stimulation therapy parameters.

Abstract: Poly(orthoester) polymers, and methods of making and using such poly(orthoester) polymers are provided. The poly(orthoester) polymers can be useful for applications including, for example, medical devices and pharmaceutical compositions. In a preferred embodiment, the poly(orthoester) polymers are biodegradable.

Abstract: The invention describes poly(ortho ester) polymers that include at least one therapeutic compound in the polymer backbone. The therapeutic compound includes at least one phenol residue and an aliphatic alcohol residue or two or more phenolic residues.

Abstract: A bulking device for implantation into a lumen wall that includes a bulking material that is configured to alter the portion of the lumen into which it is implanted and one or more therapeutic substances in association with the bulking material, wherein the device is configured to alter the portion of the lumen wall into which it is implanted. A method for inserting devices of the invention are also included.

Abstract: The disclosure is directed to gastric stimulation programmers, stimulators and methods for controlling delivery of gastric stimulation therapy to maintain the efficacy of the therapy over time. Maintaining the efficacy of gastric stimulation therapy may be possible by implementing one or more anti-desensitization features in a gastric stimulation controller or stimulator. As electrical stimulation therapy is continuously delivered to a patient, the stimulated tissue may become desensitized to the electrical stimulation therapy such that the beneficial effect of the electrical stimulation is diminished. Once desensitization occurs, the affected tissue may not respond favorably to electrical stimulation therapy. Application of one or more anti-desensitization features to control gastric stimulation therapy may reduce or prevent desensitization and effectively extend the efficacy of the therapy over time.

Abstract: A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable valve support. If desired, one or more anchor may be used. The valve support, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned. The anchor engages the lumen wall when expanded and prevents substantial migration of the valve assembly when positioned in place. The prosthetic valve assembly is compressible about a catheter, and restrained from expanding by an outer sheath. The catheter may be inserted inside a lumen within the body, such as the femoral artery, and delivered to a desired location, such as the heart.

Abstract: An improved tissue engagement device such as a suction stabilizer or retractor. The stabilizer or retractor is provided with one or more suction pods mounted to the distal end of a flexible arm. The flexible arm is coupled to a base assembly, which attaches the arm to an associated retractor or other structure that is fixedly located relative to the operative site. The base assembly includes a fixed portion, which is coupled to the retractor or other fixed mounting point and a rotatable turret, allowing rotation of the arm relative to the fixed portion of the base assembly. A tensioning mechanism mounted to the turret applies tension to compress the turret around a corresponding pivot mounted to the fixed portion of the base to rotationally lock the turret and to lock the arm in its current configuration.

Abstract: A valve repair system, preferably including an annuloplasty prosthesis and a holder for the prosthesis. The holder includes a first component having a central opening, a circumferential surface and an outwardly extending member. The annuloplasty prosthesis is located adjacent to the circumferential surface, above the outwardly extending member. The holder further includes a second component movable upwardly relative to the first holder component and includes a rigid penetrating member extending downward from the second component into the prosthesis, holding it adjacent the circumferential surface. The holder also includes a suturing guide for assisting a physician in valve repair surgery, which may be a cuttable suture extending across the central opening along a path approximating a desired line of leaflet coaption. The cuttable suture may additionally secure the first and second components to one another.

Abstract: Methods and apparatus for delivering precise amounts of fluid under pressure into cardiac tissue for the purpose of facilitating ablation of the tissue along a desired lesion line. One method injects fluid under pressure through a discharge orifice in a needle-less injection device. The injected fluid can be a cytotoxic fluid and/or a highly conductive fluid injected in conjunction with radio frequency ablation to create an ablative virtual electrode. The injected fluid can provide deeper and narrower conduction paths and resulting lesions. Radio frequency ablation can be performed at the same time as the fluid injection, using the injection device as an electrode, or subsequent to the fluid injection, using a separate device. In some methods, the injected fluid is a protective fluid, injected to protect tissue adjacent to the desired lesion line. Fluid delivery can be endocardial, epicardial, and epicardial on a beating heart.

Abstract: The delivery system of the present invention is comprised of at least two chambers which store, individually, an activated blood component and an inactivated blood component. The first chamber comprises an activating agent and a filter which may be one in the same thus allowing the formed clot to be triturated thereby isolating the thrombin from the clot. The second chamber stores the inactivated blood component that when mixed with thrombin will produce a gel. The first or second chamber may further contain agents which are desired to be delivered to a specific site. The unique design of the delivery system allows for ease in operation of combining two agents at a specific time and place.

Abstract: Medical devices and methods for accessing an anatomical space of the body and particularly for penetrating the epicardium to access pericardial space and the epicardial surface of the heart in a minimally invasive manner employing suction are disclosed. The distal end of a tubular access sleeve having a sleeve wall surrounding a sleeve access lumen and extending between a sleeve proximal end and a sleeve distal end having a plurality of suction ports arrayed around the sleeve access lumen distal end opening is applied against an outer tissue layer. Suction is applied through the plurality of suction ports to a plurality of portions of the outer tissue layer. A perforation instrument is introduced through the sleeve access lumen to perforate the outer tissue layer to form an access perforation into the anatomic space while the applied suction stabilizes the outer tissue layer, whereby further treatment drugs and devices can be introduced into the anatomic space.

Abstract: Methods and apparatuses for the separation a predetermined cellular component from a bodily fluid or tissue by centrifugation are provided. More specifically, this invention provides a method for the separation and isolation of one or more components, such as stem cells, buffy coat, bone marrow cells, erythrocytes, leukocytes, thrombocytes, serum, fluorescently labeled cells, and magnetically labeled cells, from whole blood, bone marrow, buffy coat, fat tissue, muscle tissue, and nerve tissue by centrifugation, wherein the components are isolated while the centrifuge is rotating.

Abstract: An implantable article and method are disclosed for treating pelvic floor disorders such as vaginal vault prolase. A surgical kit useful for performing a surgical procedure such as a sacral colpopexy is also described.

Abstract: A rotatable rotor for separating components contained in a fluid, comprising an annular base having a first annular channel and an annular cover having a second annular channel for holding a flexible doughnut-shaped centrifuge bag therebetween. The cover has one or more radially spaced apart concentric indicator lines for monitoring the separation of the components. When the base and cover are superimposed, the first and second channels define an annular interior chamber having an off-centered figure eight configuration. The base and cover each comprise a grooved column axially centered and extending from the base top surface and the cover bottom surface, respectively. The flexible bag comprises inner and outer tubes extending from the core of the bag and which are seated in the column grooves to ensure that the bag is fixably rotatable with the rotor.

Abstract: The present relates to an autologous bioadhesive sealant composition or fibrin glue prepared by a two-phase method, wherein all of the blood components for the bioadhesive sealant are derived from a patient to whom the bioadhesive sealant will be applied. A platelet rich plasma and a platelet poor plasma are formed by centrifuging a quantity of anticoagulated whole blood that was previously drawn from the patient. In one embodiment, the platelet rich plasma is divided into two portions. In phase one, a compound that reverses the effect of the anticoagulant is added to the first portion and a clot is allowed to form. The clot is then triturated, and the resulting serum containing autologous thrombin is collected. In phase two, the serum obtained from phase one is mixed with the second portion of the platelet rich plasma to form the bioadhesive sealant of the present invention.

Abstract: A flexible, disposable centrifuge bag for receiving and holding a fluid sample, comprising one or more tubes and upper and lower flexible sheets having doughnut shaped configurations. The upper and lower sheets are superimposed and completely sealed together at their outer perimeters to define an outer perimeter of the centrifuge bag. The inner perimeter of the bag defines a central core. The tubes are sandwiched between the upper and lower sheets and extend from the central core of the centrifuge bag. The upper and lower sheets are sealed together at their inner perimeters such that the tubes are sealed between said upper and lower sheets at the inner perimeter. The bag may be used to harvest platelet rich plasma from whole blood in either a batch method or while simultaneously infusing additional aliquots of whole blood into the bag during centrifugation.

Abstract: A system and method of making a lesion on living tissue including providing an electrosurgical system, determining a desired lesion depth, selecting a power setting, and applying electrical energy to the living tissue. The system includes an instrument having an electrode at a distal portion thereof, and a power source having multiple available power settings. The power source is electrically connected to the electrode. The step of applying electrical energy includes energizing the electrode at the selected power setting for a recommended energization time period that is determined by reference to predetermined length of time information and based upon the desired lesion depth and the selected power setting. The system preferably further includes a fluid source for irrigating the electrode at an irrigation rate. In this regard, the predetermined length of time information is generated as a function of irrigation rate.

Abstract: A method of and a system for treatment of atrial tachyarrhythmias. The system includes a set of hemostats having elongated opposing jaws carrying mechanisms for applying ablation energy along the jaws. The jaws having straight and curved configurations selected to allow arrangement of the jaws of along opposite sides of walls of a patient's atrium. Treatment is accomplished by applying of ablation energy to the walls of a patient's artria to create lines of lesion corresponding generally to incisions employed in a Maze type procedure.