Cook Vascular Incorporated

William J Boyle

Chun Kee Lui

Barry E Norlander

A hemostatic valve couples to a sheath proximal hub having an inside and an outside surface. The hemostatic valve has a valve body having a proximal porting and end, and a distal portion and end. A passageway extends longitudinally through the valve body between the proximal and distal ends. A sealing element is positioned within the passageway. The distal portion of the valve body includes a pair of contact surfaces forming an annular gap receiving the sheath proximal hub of the sheath so that the contact surfaces sandwich the sheath proximal hub forming a seal on both the inside and outside surfaces of the hub. The valve body and the sheath proximal hub includes two oppositely placed longitudinal lines of fissure that allow the hub to be separated into two halves with the valve body.

Splittable medical valve

A splittable medical valve is disclosed that is configured with a interfacing region that permits the valve to be placed over or inside of a tubular medical device, such as a splittable introducer sheath, to prevent loss of bodily fluids and/or reduce ingress of air-borne pathogens. The valve further includes a sealing element configured to accept passage of a medical device, such as a catheter, sheath, pacemaker lead, or other ancillary device therethrough, whereby the valve body is split along one or more lines or fissure to allow removal of the valve from around the ancillary device.

An introducer apparatus ( ) comprising a pair of co-extending splittable introducer sheaths ( ), ( ) is disclosed. The unique properties (pushability, torqueability, length, shape, etc.) of the individual introducer sheaths yields an introducer apparatus with the additional navigational flexibility to reach a remote target that whose access would be more difficult or impossible with a single introducer sheath. One embodiment include a coaxial pair of introducer sheaths made of made of molecularly oriented (non-isotropic) polytetrafluoroethylene PTFE which are used for placement of a pacemaker or defibrillator lead into the coronary sinus. In this embodiment, the first introducer sheath ( ) is introduced over a wire guide into ostium of the coronary sinus, which represents the first target site. The outer introducer sheath includes preformed bends ( ) to facilitate passage through the vasculature. A second introducer sheath ( ), which includes a curved distal portion ( ), is introduced through the first introducer where it extends from the distal end of the outer introducer sheath to access the second, ultimate target site, such as a coronary artery branching from the coronary sinus. After the pacemaker lead has been placed, both sheaths are split and removed from the patient.

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Lower Burrell, PA, United States of America

William J Boyle