Advanced Cardiovascular Systems, Inc.

Cardiac Pacemakers, Inc.

Eric D Peterson

Jessica G Chiu

Joseph P Loeffler

Jon A Becker

Firas Mourtada

Paul Reiss

Manolo Lumauig

Mark Newton

A guiding catheter system employs an outer jacket with one or more inflation lumens provided along the length of the jacket. The lumens are in fluid communication with one or more fluted balloons mounted at a distal end of the outer jacket. A torquable stylet is movably disposed within an open lumen of the outer jacket. A guidewire is movably disposed in an open lumen of the torquable stylet. The outer jacket can be provided with break-away features allowing the jacket to be peeled off of a pacing lead.

System and method for accessing the coronary sinus to facilitate insertion of pacing leads

A multi-lumen balloon for use in a fluted balloon centering catheter and method for providing the same. The multi-lumen balloon maintains a radiation source at the center of a cardiovascular artery, has improved blood perfusion capability, and has improved balloon refolding characteristics. The method of fabricating a multi-lumen balloon designed for a radiation centering catheter uses an improved extrusion process that allows the manufacture of the multi-lumen balloon sub-assembly to be done separately from the catheter shaft assembly.

Multi-lumen fluted balloon radiation centering catheter

A stepped centering catheter for delivery of intravascular radiation therapy including a central segment of a first effective diameter and smaller, offset segments of second effective diameters to each side of the central segment. The first effective diameter of the central segment substantially centers a portion of a radiation source within the lumen of a vessel along a therapeutic treatment length. The second effective diameters of the offset segments constrain portions of the radioactive source that extend beyond the therapeutic treatment length within a region having a minimum offset distance from the vessel wall. The first effective diameter of the central segment is gradually tapered to the second effective diameter of the offset segments across first steps. The second effective diameters of the offset segments are gradually tapered to the diameter of the catheter shaft across second steps. The smaller diameter offset segments and tapered change in diameters mitigates further injury to vessel walls located outside the therapeutic treatment length.

Stepped centering balloon for optimal radiation delivery

A novel proximal shaft design used for the manufacture of a catheter. In particular, the proximal shaft design provides excellent stiffness and kink resistance with a reduced outer catheter shaft diameter for improved catheter performance. The proximal shaft design incorporates a shaft with radially extending ridges that have inset regions positioned between adjacent ridges. The catheter may be used in delivering and maintaining a radiation source in a patient's body lumen, such as a coronary artery, for a specified period of time. The proximal shaft design can be applied to other treatments and treatment sources, as well as, other catheter designs.

Proximal catheter shaft design and catheters incorporating the proximal shaft design

Multi-lumen extrusion tubing

A radioactive catheter system, including a plurality of medical catheter assemblies, to irradiate patient's bodies having a variety of treatment requirements, configured to eliminate the need to maintain a selection of radiation source wires. The catheter assemblies each include a catheter that defines a lumen configured to receive a radiation source wire from an afterloader. Each catheter assembly includes at least one radiation shield configured and located to form a treatment region, so as to shield a portion of the radiation source from irradiating a patient's body. The radiation shield surrounds the lumen circumferentially over a first and second longitudinal portion of the catheter, forming a treatment window configured to only allow portions of the positioned radiation source longitudinally within the treatment window to primarily irradiate portions of the body. The radiation shield may comprise coils of radiation shielding material, or adjacent rings of radiation shielding material. The catheter assembly may include radial centering devices adjacent the radiation shield. The plurality of catheter assemblies include a plurality of different treatment regions to accommodate a variety of treatment requirements.

Catheter assembly incorporating radiation shielding and related method of use

The invention is directed to a radiation source for delivery of a radiation treatment to a body lumen. The radioactive tip of the source wire is detachable from the main portion of the core wire to allow the radioactive source in the tip to be sterilized and re-sterilized independently of the core wire. The detachable radioactive tip also includes a flexible portion for improved tracking through a lumen of a catheter.

Tip configuration for radiation source wires

This invention is directed to a method of bonding thermoplastic catheter parts to a metallic member such as hypotubing and the product formed. The polymeric material is hot pressed against the metallic member with sufficient pressure to ensure plastic deformation of the polymeric material. A fluid tight bond is formed which can withstand pressures of up to 650 psi.

Bonding a polymer member to a metallic member

The invention is directed to a radiation delivery catheter assembly for maintaining patency of a body lumen for a period of time sufficient to allow delivery of a radiation source to the body lumen. The catheter utilizes an inflatable region which maintains and centers the catheter in the body lumen. The catheter may include a perfusion lumen for supplying oxygenated blood to tissue located downstream from the catheter when the inflatable region is expanded in the body lumen. The inflatable region can be made up of a plurality of balloon segments which help center the radiation source, even if placed on a curved section of the body lumen. Embodiments of the invention include a catheter design which utilizes &ldquo;rapid exchange&rdquo; features and a dual therapeutic catheter which is capable of dilating a stenosed region of the body lumen prior to the administration of the radiation treatment. A two-piece protective sheath is used to protect the radiation source from bodily fluids.

Radiation centering catheters

A radiation delivery catheter which increases the margin of safety and reduces unintended exposure to radiation dosage during delivery thereof to a target area to reduce the likelihood of the development of restenosis. The catheter includes a shaft comprised of radiation shielding material, to shield the patient and staff from unintended radiation exposure. The catheter further includes a treatment section including a reservoir balloon comprised of radiation trans-parent material, which enables predetermined concentrations of radioactivity in the radiation source to permeate therethrough into the target area in a substantially uniform dosage pattern.

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Fremont, CA, United States of America

Eric D Peterson