Abstract: A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

Abstract: Described in one aspect is a multi-pressure monitoring system for cell or other therapy includes a first catheter having a first lumen for accepting a treatment device, a second lumen for inflating a balloon, a pressure sensor for monitoring fluid pressure within the first lumen, and a flow restrictor such as a hemostasis valve for limiting the exchange of fluids into and out of the first lumen while treatment devices are present or exchanged in the first lumen. Also disclosed is a method of using the first catheter with a first pressure monitor coupled to the first pressure sensor along with a second catheter attached to a second pressure sensor coupled to a second pressure monitor. The second catheter is positioned within the first lumen of the first catheter during treatment operations and the first and second pressure monitors are used to verify proper pressures throughout the procedure.

Abstract: Intravascular devices and systems useful for blocking the opening of an aneurysm or a vessel branch are disclosed. In some aspects, the disclosure provides arrangements that align a covering material of a stent graft with an opening in the vessel wall before, during, and/or after expansion of the stent graft within the vasculature of a patient. In some instances, systems and devices include a sheath with a side aperture arranged to align a portion of the sheath and/or a portion of a stent graft contained within the sheath with the mouth of an aneurysm. Similarly, the present disclosure also provides embodiments in which the stent graft comprises an aligning member arranged to align the stent graft and/or a sheath with the mouth of an aneurysm. Other embodiments are disclosed.

Abstract: A device for internal ultrasound imaging including a micro-motor rotates a drive shaft and ultrasound transducer. Conductors attach between the transducer and slip ring assemblies. The slip ring assemblies conductively couple the transducer conductors to a set of conductors extending toward a console.

Abstract: Disclosed are embodiments of devices and methods for imaging the inside of a body part, such as a blood vessel. In particular embodiments, a catheter has a chamber within which is a transducer. A wire guide channel extends throughout the length of the catheter. The transducer is rotatable about the wire guide channel and the transducer is driven by a cable or other device that is connected to a motor which is located outside the catheter. In one form, a torque cable connects the transducer to the motor. In other embodiments, a pusher piece having a plurality of lumens is positioned in the catheter. Each of the lumens is sized to receive a cable, wire, and/or flushing fluid. The lumens maintain the orientation and separation of the cables, wires, and/or to flushing fluid.

Abstract: An endovascular prosthesis that includes a stent and a woven graft material. The stent is connected to the graft material by direct attachment of the stent to the graft material at thermoplastically fused regions of the graft material.

Abstract: Attachable implements, systems, and methods for identifying the migration of a medical device extending through a percutaneous insertion site of a patient's skin are disclosed. In one embodiment, an attachable implement for identifying migration comprises a attachable implement body having a coupling surface and a skin contacting surface, the coupling surface arranged to couple to a surface of the medical device, and the skin contacting surface arranged to contact the skin of the patient; wherein the attachable implement body is arranged to be side mountable on the medical device and wherein the attachable implement is configured to move from a first position adjacent to the patient's skin to a second position remote from the patient's skin. Systems, methods, and other embodiments are disclosed.

Abstract: A device for internal ultrasound procedures includes a motor which rotates a drive shaft and an ultrasound transducer. A gearing assembly provides reciprocating rotational motion from a unidirectional motor. A cam assembly provides reciprocating pivotal motion to the transducer. Conductors can attach to the transducer and extend through the drive shaft.

Abstract: A system for use with ultrasound procedures including an ultrasound control and/or imaging system which has a microminiature motor, a rotatable reflector and a stationary ultrasound transducer. The transducer may be placed between the motor and the reflector, so as to eliminate the need for placement of wires or other artifact-creating items in the path of ultrasound signals. In particular embodiments, such systems can be incorporated in or retrofitted to commercially standard diagnostic and therapeutic catheters or other housings. Examples can be used in variety of ultrasound procedures, e.g. to perform intravascular ultrasound (IVUS) imaging.

Abstract: A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

Abstract: Osteogenic compositions include a decellularized extracellular matrix tissue and bone morphogenic protein, preferably BMP-2. The compositions make beneficial use of the BMP, which can be used at relatively low doses and can bind to native components (e.g., native sulfated glycosaminoglycans such as heparin and/or heparan sulfate) remaining in the decellularized extracellular matrix tissue. Methods for preparation and use of such compositions are also described. The compositions and related methods can be used in the treatment of diseased or damaged bone tissue.

Abstract: The present invention provides, in certain embodiments, unique products and methods for occluding vascular vessels. Implantable devices useful in some inventive embodiments include at least two expandable occluding members, e.g., self-expandable sponge form devices, with an intermediate segment extending between the members. These devices are preferably compressible for placement in a delivery device lumen for delivery to a vascular vessel site. Upon deployment in the vessel, each of the members expands to occlude the vessel at a separate vessel location with the intermediate segment occupying space in the vessel between the two members. Optionally, the intermediate segment can be constructed to provide a hollow or other interior region for receiving one or more materials, for example, to receive an injectable fill material after one or both of the expandable members have been deployed.

Abstract: Described are embodiments of a multilaminate or multiple layer implantable surgical graft with an illustrative graft comprising a remodelable collagenous sheet material, the graft including one or more interweaving members to stitch together the graft to help prevent the layers from delaminating or separating during handling and the initial stages of remodeling. The interweaving members may comprise lines of suture, thread, individual stitches, strips of material, etc. that are woven through the layers of biomaterial in a desired pattern. In one embodiment, the interweaving members comprise a pharmacologically active substance, such as a drug, growth factors, etc. to elicit a desired biological response in the host tissue. In another embodiment, the graft further comprises a reinforcing material, such as a synthetic mesh, within the layers of remodelable biomaterial and stitched together by one or more interweaving members.

Abstract: Among other things, there is provided a system for providing therapeutic cooling or hypothermia to localized areas of the body such as the brain. A source of compressed gas such as a medical-use oxygen canister is connected via a delivery tube to a mask fitted to a patient. The gas undergoes adiabatic cooling as it enters the delivery tube, and is provide to the patient in such cooled state. The system may be provided as a portable or ambulatory device or kit, with the delivery tube or other part easily disconnected from one compressed gas source and connected to another, for continued therapy even during transportation.

Abstract: Described are methods and systems for testing lumens of cannulated delivery components or assemblies thereof that may be used to deliver cells to a patient. Test cells are contacted with walls of the lumens and/or liquids that contact walls of the lumens, potentially over an incubation period. The test cells are then assessed for an effect of the wall contact, or the liquid contact, on at least one and preferably multiple characteristics of the test cells such as innate immune response, metabolic activity, viability, cytotoxic response, and/or motility. Methods and systems as described can be used in the development and/or manufacture of cannulated delivery devices, for example providing specifications for design or process inputs or outputs, design or process validations, and/or device lot approvals. Also described are devices or products produced in accordance with such methods and systems.

Abstract: Described are embodiments of a multilaminate or multiple layer implantable surgical graft with an illustrative graft comprising a remodelable collagenous sheet material, the graft including one or more interweaving members to stitch together the graft to help prevent the layers from delaminating or separating during handling and the initial stages of remodeling. The interweaving members may comprise lines of suture, thread, individual stitches, strips of material, etc. that are woven through the layers of biomaterial in a desired pattern. In one embodiment, the interweaving members comprise a pharmacologically active substance, such as a drug, growth factors, etc. to elicit a desired biological response in the host tissue. In another embodiment, the graft further comprises a reinforcing material, such as a synthetic mesh, within the layers of remodelable biomaterial and stitched together by one or more interweaving members.

Abstract: Described are methods, cell growth substrates, and devices that are useful in preparing cell-containing graft materials for administration to patients. Tubular passages can be defined in cell growth substrates to promote distribution of cells into the substrates. Also described are methods and devices for preparing cell-seeded graft compositions, methods and devices for preconditioning cell growth substrates prior to application of cells, and cell seeded grafts having novel substrates, and uses thereof.

Abstract: Described in one aspect is a multi-cell or multi-chambered container for sealing various materials such as therapeutic or diagnostic agents, animal or human tissue, tissue samples, specimens, blood, genetic material, or any other material. The container includes seals formed by folding the wall of the elongate body transverse to the interior of the elongate body and maintaining the folded wall portions adjacent one another or joining them together. In another aspect, the container disclosed may be made according to a method involving creating multiple seals at various locations along the elongate body thus creating sealed voids or cells between the seals within the elongate body.

Abstract: There are disclosed embodiments of devices and methods for imaging the inside of a body part, particularly a blood vessel. In particular embodiments, a catheter has a tip chamber, within which is an ultrasound transducer mounted on a pivot mechanism, a motor for turning the transducer, and an implement for pivoting the transducer. Examples of such an implement are a linear motor, a shaft or filament, and the pivot mechanism may be biased to return to a base position when the implement is not pivoting the transducer. In other embodiments, a mirror reflecting ultrasound signals from the transducer may be rotated and/or pivoted, using similar mechanisms.

Abstract: Described are methods, cell growth substrates, and devices that are useful in preparing cell-containing graft materials for administration to patients. Tubular passages can be defined in cell growth substrates to promote distribution of cells into the substrates. Also described are methods and devices for preparing cell-seeded graft compositions, methods and devices for preconditioning cell growth substrates prior to application of cells, and cell seeded grafts having novel substrates, and uses thereof.