Atrium Medical Corporation

Peter H Gingras

Theodore Karwoski

Steve A Herweck

Paul Martakos

Jonathan L Goodwin

Gary Jordan

Tom Swanick

Susan Hamelin

Ryan A Amara

A method of making a radially expandable fluid delivery device includes providing a tube of biocompatible fluoropolymer material with a predetermined porosity based on an extrusion and expansion forming process, applying a radial expansion force to the tube expanding the tube to a predetermined diameter dimension, and removing the radial expansion force. The tube is radially inelastic while sufficiently pliable to be collapsible and inflatable from a collapsed configuration to an expanded configuration upon introduction of an inflation force, such that the expanded configuration occurs upon inflation to the predetermined diameter dimension. The fluid delivery device is constructed of a microporous, biocompatible fluoropolymer material having a microstructure that can provide a controlled, uniform, low-velocity fluid distribution through the walls of the fluid delivery device to effectively deliver fluid to the treatment site without damaging tissue proximate the walls of the device.

Expandable fluoropolymer device for delivery of therapeutic agents and method of making

A radially expandable device having a body constructed of a generally inelastic, expanded fluoropolymer material is described. The body is deployable upon application of a radial expansion force from a reduced diameter, collapsed configuration to an expanded configuration having a pre-defined and fixed increased diameter. The body has a singular, unitary construction of generally homogenous material that is characterized by a seamless construction of expanded fluoropolymer material, such as expanded polytetrafluoroethylene (ePTFE), and is preferably constructed through an extrusion and expansion process. The body is further characterized by a microstructure of nodes interconnected by fibrils in which substantially all the nodes of the body are oriented generally perpendicularly to the longitudinal axis of the body. The monolithic construction of the body and the orientation of the nodes, perpendicular to the longitudinal axis of the body, yields a radially expandable device that predictably and dependably expands to a predefined, fixed maximum diameter that is generally independent of the expansion force used to radially expand the device. In addition, the microstructure of nodes interconnected by fibrils provides at least one predetermined flow rate of fluid therethrough over a range of fluid pressures.

Expandable fluoropolymer device and method of making

A radially deployable covered stent that predictably and dependably expands to an increased diameter state at relatively low deployment pressures while concomitantly minimizing the risk of tearing of the stent covering during expansion. The stent covering includes an inner cover and an outer cover that are bonded together through and around the stent structure to cover the stent. The stent cover is constructed from expanded polytetrafluoroethylene (ePTFE) having a structure of nodes interconnected by fibrils. The stent covering has a radial thickness of at least about 0.008&#x2033; and an average internodal distance (IND) of at least about 100 microns when the stent is in the reduced diameter, unexpanded state. The covered stent deploys at an average deployment pressure of less than or equal to about 10 atm. A method for covering a stent structure according to the present invention includes placing a compression member in the form of a tubular sleeve over the outer cover and heating the compressed covered stent to bond the inner cover to the outer cover. An adhesive in the form of an aqueous dispersion of PTFE can be applied to either the inner cover or the outer cover to facilitate bonding of the inner cover to the outer cover.

Covered stent and method of covering a stent

A radially expandable fluid delivery device for delivering a fluid to a treatment site within the body is disclosed. The fluid delivery device is constructed of a microporous, biocompatible fluoropolymer material having a microstructure that can provide a controlled, uniform, low-velocity fluid distribution through the walls of the fluid delivery device to effectively deliver fluid to the treatment site without damaging tissue proximate the walls of the device. The fluid delivery device includes a tubular member defined by a wall having a thickness transverse to the longitudinal axis of the tubular member and extending between an inner and an outer surface. The wall is characterized by a microstructure of nodes interconnected by fibrils. The tubular member is deployable from a first, reduced diameter configuration to a second, increased diameter configuration upon the introduction of a pressurized fluid to the lumen. The tubular member includes at least one microporous portion having a porosity sufficient for the pressurized fluid to permeate through the wall. Substantially all of the nodes within the microporous portion are oriented such that spaces between the nodes form micro-channels extending from the inner surface-to the outer surface of the wall.

A radially deployable covered stent that predictably and dependably expands to an increased diameter state at relatively low deployment pressures while concomitantly minimizing the risk of tearing of the stent covering during expansion. The stent covering includes an inner cover and an outer cover that are bonded together through and around the stent structure to cover the stent. The stent cover is constructed from expanded polytetrafluoroethylene (ePTFE) having a structure of nodes interconnected by fibrils. The stent covering has a radial thickness of at least about 0.008&Prime; and an average internodal distance (IND) of at least about 100 microns when the stent is in the reduced diameter, unexpanded state. The covered stent deploys at an average deployment pressure of less than or equal to about 10 atm. A method for covering a stent structure according to the present invention includes placing a compression member in the form of a tubular sleeve over the outer cover and heating the compressed covered stent to bond the inner cover to the outer cover. An adhesive in the form of an aqueous dispersion of PTFE can be applied to either the inner cover or the outer cover to facilitate bonding of the inner cover to the outer cover.

A method and apparatus relating to a biocompatible soft tissue implant is disclosed. The implant, in the form of a prosthesis, is constructed of a knitted pile mesh material arranged into either a 3-dimensional structure or a planar shape or structure. The material or fabric includes a plurality of filament extensions projecting outwardly therefrom. The filament extensions can be radially projecting looping filaments from one or more rows of the knitted pile mesh material. The combination of the filament extensions with the 3-dimensional structure results in the biocompatible implant having a structural resistance to hinder anticipated crushing forces applied to the implant, and also provide a suitable 3-dimensional structure for promoting rapid tissue in-growth to anchor such implant without migration and strengthen the repaired tissue area.

Pile mesh prosthesis

A vascular endoprosthesis is formed of a tubular liner preform with a continuous surface and having a diameter smaller than that of an intended vessel. The liner is inserted to a treatment site, and its sheet material undergoes a radially-directed expansion to a final size that fits the vessel. Insertion and in situ expansion are achieved using a catheter assembly in which either an internal stent, such as a stiff-filament helically woven tube, or an inflatable balloon urge the liner preform outwardly against the inner wall of the vessel. The stent, or one or more simple internal snap-rings anchor the expanded liner in place. The expanded liner is porous, or becomes more porous during expansion, and one or more aspects of its porosity are tailored to the intended treatment goal of immobilizing treatment material, isolating cells, or permitting controlled permeation of selected materials.

Vascular endoprosthesis and method

A porous tube suitable for use as a vascular graft prosthesis and a method of making it is disclosed. It has a structure of porous polytetrafluoroethylene having a fibrous structure of nodes and fibers connecting the nodes together and an integrated intrawall circumferential support adjacent to areas of variable porosity. This invention provides a polytetrafluoroethylene polymer in a porous form useful as artificial internal organs for, for example vascular bypass, vascular access, and endovascular prosthesis. PTFE walls are found with radial zones of differing porosity are described.

Multi-stage prosthesis

A method of making a radially expandable device having a body constructed of a generally inelastic, expanded fluoropolymer material. The body is deployable upon application of a radial expansion force from a reduced diameter, collapsed configuration to an expanded configuration having a pre-defined and fixed increased diameter. The body has a singular, unitary construction of generally homogenous material that is characterized by a seamless construction of expanded fluoropolymer material, such as expanded polytetrafluoroethylene (ePTFE), and is preferably constructed through an extrusion and expansion process. The body is further characterized by a microstructure of nodes interconnected by fibrils in which substantially all the nodes of the body are oriented generally perpendicularly to the longitudinal axis of the body. The monolithic construction of the body and the orientation of the nodes, perpendicular to the longitudinal axis of the body, yields a radially expandable device that predictably and dependably expands to a predefined, fixed maximum diameter that is generally independent of the expansion force used to radially expand the device.

Method of making an expandable fluoropolymer device

An expandable prosthesis includes a self-expanding stent deployable between a substantially radially compressed configuration and a substantially radially expanded configuration. A biocompatible coating is attached to at least a portion of the outer surface of the self-expanding stent in the radially compressed configuration to inhibit radially expansion of the self-expanding stent to the radially expanded configuration. The biocompatible material is preferably integrally mounted to the self-expanding stent thus eliminating the need for a separate, independent delivery tube or sheath for maintaining the self-expanding stent in the radially compressed configuration during delivery of the self-expanding stent into a body vessel.

Self-expanding prothesis

A radially expandable support body is enveloped within a cocoon. In a preferred construction, the support is a stent, and a tube of polymeric material, e.g., polytetraeluoroethylene (PTFE), passes through the interior of the stent body and is turned back upon itself over the stent to form a cuff. The assembly is then heated and the outer layer contacts and coalesces with the inner layer, closely surrounding the stent body within a folded envelope having a continuous and seamless end. In one embodiment, an end portion of the tube is expanded before folding back over the-stent. The end portion, which becomes an exterior surface of the finished product, thus acquires a greater degree of porosity. Each end of the central tube may be so expanded, and folded back to seal all surfaces and both ends. The stent body itself may be a ring, or a short series of spaced-apart rings, or a wire or web, or a sheet possessing a number of apertures extending entirely through the sheet. The spaces or apertures are covered over or bridged by both the inner and outer polymer layers. The apertures, which may comprise under five to over eighty percent of the surface area of the stent, constitute regions or a grid of points through which the material is coalesced and continuously bonded, and around which strain is distributed by the support. These points or regions remain tacked together so expansion of the assembly does not delaminate the polymer or create flaps and pockets. In another embodiment, a two tube construction is cuffed and assembled into a similarly unitized and seamless stent. One tube is cuffed back, and the other tube covers the cuffed stent. In this embodiment both the tube thicknesses and porosities may differ substantially. For example the inner porosity may be selected to enhance blood flow or intimal regeneration, and the outer surface may have a porosity to encourage anchoring to external muscle tissue.

Expandable shielded vessel support

A prosthesis is provided that is advantageously used to fill a soft tissue or muscle defect, such as an inquinal or femoral hernia. In a first aspect of the invention, multiple layers of a flexible, mesh material are attach together at a finite number of joins. A tab is placed at the geometric center of one of the mesh layers to facilitate insertion of the mesh into the defect. The tab also creates a blunt tip that reduces irritation and discomfort to the patient. In a second aspect of the invention, a prosthesis is provided that includes a barrier layer between two or more layers of flexible, mesh material to prevent adhesion of the device to the tissue. All layers are attached together by a finite number of joins. A tab is placed at the geometric center of one of the mesh layers to facilitate insertion of the mesh into the defect. The prostheses of the invention are self-forming in that they change from a two dimensional configuration to a three dimensional configuration upon insertion of the device into the defect.

Self-forming prosthesis for repair of soft tissue defects

The wall of a prosthesis has a region which modulates communication through the porosity of the wall. The prosthesis is unitary, but may be assembled in successive bodies which are coalesced, so that the porous microstructure changes distinctly at stages through the thickness dimension of the wall. One embodiment is formed entirely of fluoropolymer, and has at least one surface adapted to support tissue regeneration and ingrowth. The modulation region is a stratum of high water entry pressure that reduces pulsatile hydraulic pressure transmission, or locally alters fluid-born-distribution of biological material through the wall and allows more natural gradients for tissue regeneration and growth in the outer region of the wall.

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Windham, NH, United States of America

Peter H Gingras