Greatbatch Ltd.

Imricor Medical Systems, Inc.

Scimed Life Systems, Inc.

Scott Kimmel

Rodolphe Katra

Kevin Pietsch

Lawrence Kane

Mark Nelson

Blane Larson

Daniel Chase

Walter John Dobrovolny

Douglas A Page

Nicholas Kampa

Michael F Hoey

Paul Anthony Iaizzo

Steven R Wedan

Jaydeep Yeshwant Kokate

Jordon D Honeck

Elliot Bridgeman

Eric M DoBrava

Grant Alexander Scheibe

Avram Bar-Cohen

Jeffrey Zweber

Marwane S Berrada

Jason M Romanowski

Suzana Prstic

Shawn J Noble

Meng Chang

Brian Pedersen

Chris Colway

Ed Goff

Brian Loushine

Gregory A Boeshans

Nicholas J Kampa

A steerable sheath with a deflection mechanism assembly is provided. The assembly includes a tubular shaft that receives first and second longitudinal movement wires at a distal end. A control handle includes a main body configured to receive first and second bevel gears. The first longitudinal movement wire is coupled to the first bevel gear and the second longitudinal movement wire is coupled to the second bevel gear. A rotatable adjustment knob is engageable with the control handle and has an external geared portion matingly engageable with the first and second bevel gears and the rotatable adjustment knob is moveable between a first and second position.

Steerable sheath deflection mechanism

Systems and methods for operating steerable sheath (SS). The methods comprise: causing an inner shaft (IS) to move in a first direction (FD) relative to an outer shaft (OS) having a first lumen (FL) in which IS is disposed; applying tension to a first pull wire (FPW) as IS moves in FD (FPW being partially disposed in a wall of IS and in FL of OS, FPW's first end being connected to IS and FPW's second end being connected to OS); allowing a deflectable region of IS's wall to transition from a straight state to a deflected state as tension is applied to FPW; causing IS to move in a second direction relative to OS; removing the tension being applied to FPW as IS moves in the second direction; and allowing the deflectable region of IS's wall to return to the straight state as tension is being removed from FPW.

Systems and methods for providing a steerable sheath with improved torque transfer during deflection

In various examples, an apparatus is configured for subcutaneously inserting an implantable device within a patient. The apparatus includes a dilator portion including a dilator including a dilator length. The dilator portion is configured to separate tissue to create a subcutaneous pocket within the patient sized and shaped to accommodate an implantable device within the subcutaneous pocket. A sheath portion includes a sheath sized and shaped to accommodate the dilator within a sheath lumen. The sheath is configured to accommodate an antenna of the implantable device with the dilator removed from within the sheath. The sheath includes a sheath length that is at least substantially as long as an antenna length. The sheath is configured to separate to allow removal of the sheath around the implantable device to remove the sheath from and leave the implantable device within the subcutaneous pocket within the patient.

Apparatus and method for implanting an implantable device

A sliding distal component assembly for use in medical catheters, bioptomes and other medical devices is provided. The sliding distal component assembly includes a tubular shaft having a lumen, the tubular shaft coupled to an actuation mechanism moveable between a first position and a second position. A tip support is coupled to the tubular shaft and defines a tip support cavity therewithin. The sliding component assembly includes a pulley system having at least one pulley, a sliding distal component and at least one pull wire coupled to the pulley and the sliding distal component with at least a portion of said pulley system being housed within said tip support cavity. When the actuation mechanism is in the first position the sliding distal component is configured to translate proximally and when the actuation mechanism is in the second position the sliding distal component is configured to translate distally.

Sliding distal component assembly

An MR compatible steerable sheath with elastomeric member is provided. The elastomeric member is configured to serve as a reservoir and receive contrast media therewithin. The elastomeric member is positioned on the distal end of the steerable sheath and may circumferentially surround the sheath shaft or be offset from a longitudinal axis thereof. In operation, the contrast media allows a user to view the distal tip of the steerable sheath by virtue of the contrast media contained within the elastomeric member.

Steerable sheath including elastomeric member

An MR compatible steerable sheath is provided. The MR compatible steerable sheath includes a steerable shaft that receives first and second longitudinal movement wires at a distal end thereof and audible or tactile means for indicating to a user the degree of deflection of the distal tip of the steerable shaft. A control handle is coupled to a proximal end of the first and second longitudinal movement wires and causes longitudinal movement of the wires.

MRI compatible control handle for steerable sheath with audible, tactile and/or visual means

A transseptal needle assembly comprised of a cannula, a handle assembly and a stylet is described. The cannula of the needle assembly is of a uniform body construction such that the cannula main portion and needle portion are fluidly connected in one-piece. The handle assembly comprises a handle housing, a handle sleeve and a handle slug. The handle slug provides ballast which improves tactile feel of the needle assembly. In addition, the stylet comprises a stylet housing having a hinged designed that allows for easier control of the stylet.

Transseptal needle assembly

An improved splittable medical device introducer designed to introduce a medical device such as a lead or catheter, into a patient's vasculature without loss of blood or introduction of air is described. The introducer assembly is designed with a notch provided at the proximal end of the introducer housing. The notch, which may comprise a multitude of cross-sectional geometries, is designed to reduce the force required to separate the housing and the introducer sheath, thereby minimizing the possibility of unintentional dislodgement during separation. The notch also increases the repeatability and consistency of the amount of force required to separate the introducer housing and sheath.

Introducer handle notch design/concept

A tunneling tool for implanting a medical device into body tissue is described. The tunneling tool comprises a first leg and a second leg. An intermediate portion of the second leg is shaped to nest a medical device therein. A hub connects the first and second distal leg ends together. A sheath providing a lumen extends from the hub to an open end distal of the first and second legs. The first and second legs are manipulatable to separate the hub and the sheath into two portions, a first split portion connected to the first leg and a second split portion connected to the second leg. When a medical device is nested in the tunneling tool, breaking the tunneling tool apart enables the first and second split portions to be removed from body tissue, leaving the implanted medical device behind.

Tunneling tool for deliberate placement of an ILR

In various examples, an apparatus includes a needle assembly including an outer cannula including a tubular sidewall disposed around a lumen. At least a portion of the sidewall includes an exterior including a polymeric material configured to inhibit skiving of an interior of a dilator with movement of the outer cannula within the dilator. An inner cannula is disposed within the lumen and is selectively slidable with respect to the outer cannula. A handle is disposed at a proximal portion of the needle assembly. The handle includes a first handle portion coupled to and movable with the outer cannula. A second handle portion is coupled to and movable with the inner cannula, wherein the first handle portion is selectively movable with respect to the second handle portion to extend a distal end of the inner cannula from within the lumen of the outer cannula.

Transseptal needle apparatus

In various examples, an apparatus includes a gripping member including a body and a gripping portion attached to the body. The body includes a passage configured to accept a needle cannula within the passage. The gripping portion includes an open configuration in which the needle cannula is movable within the passage and a closed configuration in which the gripping portion engages the needle cannula to inhibit movement of the needle cannula within the passage. A coupling member is rotatably attached to the gripping member. The coupling member is configured to selectively couple with a dilator. The coupling member includes a bore fluidly coupled with the passage, the bore being configured to accept the needle cannula within the bore.

A novel catheter is described. The catheter comprises a handle, an inner sheath providing an inner sheath lumen extending along a first length from a proximal inner sheath portion supported by the handle to a distal inner sheath portion connected to a cage gripper, and an outer sheath having a second length extending from a proximal outer sheath portion supported by the handle to a distal outer sheath portion connected to a cage housing. The inner sheath rotatably resides inside the outer sheath with the cage gripper rotatably housed inside cage housing. During a surgical procedure, a distal bridge portion of the inner sheath is connected to an opening in the lead sidewall with the lead received inside the cage housing. A gear knob is manipulated to cause the inner sheath to rotate with respect to the outer sheath so that the cage gripper is moved from an un-deployed position housed inside the cage gripper to a deployed position completely surrounding the lead connected to the distal bride. The catheter connected to the lead is moved into and to a desired location in a vasculature. Then, a screw driver is inserted through the housing and inner sheath lumens and into the lead and manipulated to screw the distal electrode into body tissue. Manipulating the gear knob causes the inner sheath to rotate the cage gripper from the deployed to the un-deployed position and then the catheter is separated from the lead and removed from the vasculature, leaving the lead behind.

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Roseville, MN, United States of America

Scott Kimmel