St Jude Medical, Atrial Fibrillation Division, Inc

St. Jude Medical, Cardiology Division, Inc.

St. Jude Medical, Daig Division, Inc.

Tc1 LLC

Tci Incorporated

St. Jude Medical International Holding S.a.r.l.

Xiaoping Guo

Richard E Stehr

David P Johnson

Daniel Joe Potter

Michael Xiaoxuan Yang

Saurav Paul

Hong Cao

Kedar Ravindra Belhe

Allan Manuel Fuentes

Eric John Wilkowske

Linda Kay Nemec

David Panus

Chad A Thorstenson

Xuan Yen Khieu

Erich W Stoermer

Nalin S Perera

Vitaliy G Epshteyn

Bruce P Holman

Donald A Sauter

Troy Terrance Tegg

James V Kauphusman

Ryan Kenneth Buesseler

Chou Thao

Steven Nicholas Willard

Riki Chou Thao

John Jason Buysman

James Holmberg

Yitzhak I Shai

Isaac Shai

Karen L Armstrong

David Hong

A delivery device for delivering a pacing lead to the His bundle of a patient's heart includes an elongated sheath having a distal end, and a plurality of mapping electrodes positioned at the distal end. The distal end of the sheath may have a distal end face, and the mapping electrodes may include two electrodes that diametrically oppose one another at a position exposed on or spaced from the distal end face. The sheath includes a plurality of flexible sections spaced apart from one another, and a pull wire that causes the sheath to deflect from a substantially straight configuration to a dual hinged curved configuration that maneuvers and positions the electrodes in the vicinity of the bundle of His. The sheath may include a PTFE liner having axially oriented, platelet-like fibril features that enable the sheath to be split along its length from a proximal end to the distal end.

Delivery device having a deflectable and peelable mapping guide sheath for his bundle pacing

The present disclosure relates generally to percutaneous heart pumps including a self-expandable and collapsible impeller housing fabricated from a mesh of a shape memory alloy, such as nitinol, and a base polymer coating and a top polymer coating. Specifically, the present disclosure relates to highly flexible and fluid-impermissible polymer coatings having improved adherence and performance properties on the metallic surfaces of the impeller housing mesh thus improving the overall performance of the percutaneous heart pumps.

Polymer coatings for shape memory alloys for use in percutaneous heart pumps

A method of manufacturing a catheter shaft includes the steps of forming an inner layer of a first polymeric material, forming a plait matrix layer including a second polymeric material about the inner layer, and forming an outer layer of a third polymeric material about the plait matrix layer. The plait matrix layer includes a braided wire mesh partially or fully embedded within the second polymeric material, which is different from at least one of the first polymeric material forming the inner layer and the third polymeric material forming the outer layer. The second polymeric material has a higher yield strain and/or a lower hardness than at least the first polymeric material, and preferably both the first and the third polymeric materials. The first polymeric material and the third polymeric material may be different or the same. The catheter shaft may be formed by stepwise extrusion, co-extrusion, and/or reflow processes.

Catheter shaft and method of its manufacture

In various embodiments of the present disclosure, a surgical catheter is provided. The present disclosure provides a catheter shaft that includes a distal portion and a proximal portion. The proximal portion comprises a handle operably connected to the distal portion of the elongated structure. The distal portion three radially positioned polymeric layers. At least two of the layers include chemically dissimilar polymers and at least one of the three layers includes functionalized polyvinylidene fluoride (PVDF).

Multilayered catheter shaft containing polyvinylidene fluoride polymers

Aspects of the present disclosure are directed to intravascular electrophysiology catheters including a catheter handle with a steering-wire locking mechanism.

Steerable intravascular catheter with releasable locking mechanism

Disclosed herein is a collapsible and self-expanding cannula for a percutaneous heart pump. The collapsible and self-expanding cannula comprises an open proximal end, an open distal end, and an elongate fluid-impermissible wall structure that includes a first balloon film, a cannula strut, and a second balloon film. The first balloon film is disposed on an interior surface of the cannula, the second balloon film is disposed on the exterior surface of the cannula, and the cannula strut is between the two balloon films. Together they form an integrated hybrid structure upon thermal fusion bonding. Also disclosed herein is a method of manufacturing the collapsible and self-expanding cannula.

Collapsible and self-expanding cannula for a percutaneous heart pump and method of manufacturing

A guidable, or steerable, or deflectable catheter is provided that includes a proximal portion and a distal portion for insertion into a body cavity. A selectively deflectable segment having an anisotropic bending stiffness for deflection in individual planes is incorporated into the distal portion of the catheter shaft. The deflectable segment comprises a corrugate structure that provides smooth curvatures of desirable configurations, deflection planarity, and easiness.

Deflectable catheter bodies with corrugated tubular structures

The present disclosure provides a medical device comprising a restraining assembly configured to assist in restraining a catheter shaft in a deflected configuration. The resistance assembly may include an inner restraining assembly and an outer restraining assembly configured to engage one another and create normal and frictional resistances therebetween sufficient to prevent unintentional and/or undesired proximal, retracting movement of an actuator, and thus, to prevent changes in a desired deflected configuration of the catheter shaft. In one embodiment, the restraining assembly is configured to allow for temporary, i.e., reversible, restraining of the catheter shaft in the deflected configuration.

Medical device including an actuator restraining assembly

A method of manufacturing a flexible tubular body for a medical device includes extruding an inner layer from a thermoplastic polymer, pulling it over a mandrel, and tightening it down. If wire lumens were not formed in the inner layer when extruded, polymer spaghetti tubes with wire lumens are laid along the outer surface of the inner layer. Deflection wires are fed into the wire lumens. A wire braid is placed over the inner layer (and spaghetti tubes, if present) and tightened down. The components are encased in an outer polymer layer and a heat shrinkable tube. Pressurized fluid is injected into each wire lumen to maintain the internal diameter thereof greater than the diameter of the deflection wire received therein. Heat is applied to the assembled components, causing the layers to laminate. Once the laminated body has cooled, the heat-shrinkable tube is removed.

Steerable catheter and methods of making the same

The invention relates to biocompatible polycarbonate/polyamide polymer compositions for use in medical and surgical devices. Additional additives, crosslinking agents, phosphites, and optionally a radiopaque filler or fillers can be used to produce the high performance compositions desired. The polymer compositions have improved melt processability along with balanced or enhanced physical and mechanical properties, especially when combined or over-extruded onto or covering other polymer layers, such as soft and/or flexible layers commonly used in medical device applications and catheter tips, for example. The ability to incorporate radiopaque compounds into these polymer compositions during melt processing offers improved methods for monitoring and visualizing medical devices when used inside the body and as well as improving the operating characteristics of the medical device components.

Biocompatible polycarbonate and radiopaque polymer compositions and methods of manufacturing medical devices with same

In various embodiments, a surgical catheter is provided. The catheter may comprise one or more hydrophobic barrier layers made from an ethylene-pertfluoroethylenepropylene ('EFEP') copolymer. Additionally, the catheter may comprise another polymer layer made from a reactive polar polymer. In at least one embodiment, the reactive polar polymer may be a modified-poly(ether block amide) ('PEBA') copolymer, such as an amine-terminated PEBA. Moreover, in various embodiments, a composition is provided that may comprise a reactive polar polymer bonded to an EFEP copolymer.

Hydrophobic catheter and composition

A body () for a catheter or sheath is disclosed. The body () includes strips () formed longitudinally from the proximal () portion of the body () to the distal () portion of the body (). The strips are formed of different materials. The strips can have different radiopacities, or can be splittable/peelable. The splittable/peelable body comprises a peel mechanism longitudinally extending along its respective length. The peel mechanism can be formed by longitudinally extending regions of interfacial bonding between first and second longitudinally extending strips of polymer material. A region of stress concentration extends along the region of interfacial bonding. The stress concentration facilitates the splitting of the body () along its peel mechanism. The polymer material of the first strip () can have a greater amount of radiopaque filler than the polymer material of the second strip (). Each strip forms at least a portion of an outer circumferential surface of the body ().

Body for a catheter or sheath

Growing community of inventors

Eden Prairie, MN, United States of America

Xiaoping Guo