C. R. Bard, Inc.

Medtronic Ave, Inc.

Richard T Choh

Stephen J Forcucci

Richard A Gambale

Michael F Weiser

Sean Forde

Robert L Cafferata

John R Fagan

Nareak Douk

Richard Morrill

Implants and associated delivery systems for promoting angiogenesis in ischemic tissue are provided. The implants may be delivered percutaneously, thoracically or surgically and are particularly well suited for implantation into the myocardium of the heart. The implants are configured to have a first configuration having a low profile and an expanded, second configuration having a large profile. The implants are delivered to the ischemic tissue location in the first configuration, implanted then expanded to the second configuration. The expanded implants maintain a stress on the surrounding tissue, irritating and slightly injuring the tissue to provoke an injury response that results in angiogenesis. The flow of blood from the surrounding tissue into the implant and pooling of the blood in and around the implant leads to thrombosis and fibrin growth. This healing process leads to angiogenesis in the tissue surrounding the implant. Additionally, the implants may contain an angiogenic substance or a thrombus of blood, preloaded or injected after implantation to aid in initiating angiogenesis.

Vascular inducing implants

Implants and associated delivery systems for promoting angiogenesis in ischemic tissue are provided. The implants may be delivered percutaneously, thoracically or surgically and are particularly well suited for implantation into the myocardium of the heart. The implants are configured to be flexible so that they compress and expand with corresponding movement of the surrounding tissue into which they are implanted. The flow of blood into the implant and pooling of the blood in and around the implant leads to thrombosis and fibrin growth, a healing process that leads to angiogenesis in the tissue surrounding the implant. Additionally, the implants may contain an angiogenic substance or a thrombus of blood, preloaded or injected after implantation to aid in initiating angiogenesis.

Flexible vascular inducing implants and methods

The present invention provides a transthoracic drug delivery device that utilizes pressure to determine the precise location of the distal tip of the delivery tube of the device to insure that therapeutic substances are ejected into the myocardium and not dissipated in unintended tissue locations. In one embodiment the drug delivery device comprises a pressure sensing tube mounted in parallel to a drug delivery tube wherein the tubes are staggered so that the pressure tube extends beyond the delivery tube. When the myocardium is penetrated by the tubes, advancement into the heart and penetration into the left ventricle by the pressure sensing tube results in a pressure increase that indicates to the physician that the drug delivery tube, by its placement relative to the pressure sensing tube is still in the myocardium and, thus, prepared to deliver the drug. In another embodiment, a steerable syringe is provided so that multiple sites in the myocardium can be treated with a therapeutic substance with only one penetration into the heart. Once the delivery tube of the syringe penetrates the left ventricle, its distal tip can be deflected back toward the endocardial surface and the tube withdrawn proximally to cause penetration of the tip into the myocardium. A pressure sensor mounted to the tube indicates, by a measured drop in pressure that the myocardium has been penetrated. The therapeutic substance is ejected into the myocardium and the device is then backed out of the tissue by advancing the syringe in a distal direction. The deflectable tip can be adjusted to a different deflection angle and the delivery tube rotated to make available a circular array of points that may be accessed by the syringe.

Transthoracic drug delivery device

The present invention provides a transthoracic drug delivery device that utilizes pressure to determine the precise location of the distal tip of the delivery tube of the device to insure that therapeutic substances are ejected into the myocardium and not dissipated in unintended tissue locations. In one embodiment the drug delivery device comprises a pressure sensing tube mounted in parallel to a drug delivery tube wherein the tubes are staggered so that the pressure tube extends beyond the delivery tube. When the myocardium is penetrated by the tubes, advancement into the heart and penetration into the left ventricle by the pressures sensing tube results in a pressure increase that indicates to the physician that the drug delivery tube, by its placement relative to the pressure sensing tube is still in the myocardium and, thus, prepared to deliver the drug. In another embodiment, a steerable syringe is provided so that multiple sites in the myocardium can be treated with a therapeutic substance with only one penetration into the heart. Once the delivery tube of the syringe penetrates the left ventricle, its distal tip can be deflected back toward the endocardial surface and the tube withdrawn proximally to cause penetration of the tip into the myocardium. A pressure sensor mounted to the tube indicates, by a measured drop in pressure that the myocardium has been penetrated. The therapeutic substance is ejected into the myocardium and the device is then backed out of the tissue by advancing the syringe in a distal direction. The deflectable tip can be adjusted to a different deflection angle and the delivery tube rotated to make available a circular array of points that may be accessed by the syringe.

Flexible vascular inducing implants

An angioplasty guidewire includes a proximal shaft formed with an axial passage and a variable stiffness intermediate section extending axially from the tubular shaft and having a corridor aligned axially with the passage and terminating at a distal joint. The intermediate section comprises a plurality of stiffening elements. A core element is slidably disposed axially through the passage and includes a distal end projecting into the corridor and attached to the distal joint while a flexible distal tip is mounted to the end of the intermediate portion and projects axially therefrom.

Variable stiffness angioplasty guide wire

An angioplasty guidewire includes a proximal shaft and an intermediate section extending from the shaft to a distal joint and having a stiffener and a flexible member. The stiffener and the flexible member are disposed in coaxial slidable relationship and operable, as the stiffener and flexible member undergo relative axial shifting, to cooperatively impart a variable stiffening force on the intermediate section. A flexible distal tip mounts to the end of the intermediate section and projects axially therefrom.

The invention relates to an apparatus and method for limiting the pressure of inflation fluid injected into a drug delivery catheter balloon, while permitting continuous and uninterrupted flow of such fluid to the balloon. The apparatus includes an elongated hollow housing having a fluid entrance, a fluid exit and a bore extending therebetween which forms an interconnecting chamber and passageway. A piston and piston shaft assembly is disposed inside the housing and is longitudinally movable within the chamber. The piston and piston shaft assembly is biased against the fluid pressure of the fluid entering the housing by a spring. The piston shaft has a distal end which extends toward the passageway inlet. As the incoming fluid pressure increases and approaches the predetermined maximum pressure level of the apparatus, the piston shaft distal end moves within the chamber against the biasing force of the spring toward a position adjacent the passageway inlet. When the incoming fluid pressure reaches and exceeds the predetermined maximum pressure level, the piston shaft distal end enters and extends into the passageway, thereby forming an annulus within the passageway. The annulus functions to restrict the flow rate and limit the pressure of the fluid exiting the housing and entering the catheter balloon.

Method and apparatus for regulating the fluid flow rate to and

The invention relates to a syringe device for limiting the pressure of inflation fluid injected into a balloon catheter. The device includes a cylindrical housing having a proximal end and a distal end. A piston is received within and reciprocally movable between the distal end and the proximal end of the housing. A shaft having a proximal end and a distal end is received within an opening at the proximal end of the housing. The distal end of the shaft is coupled to the piston and the proximal end of the shaft is coupled via a slip clutch device to a hand knob. At least a portion of the external surface of the shaft is fitted with a screw thread, which may be selectively engaged with a complementary screw thread fitted either within the opening at the proximal end of the housing or a collar coupled to the housing. When the shaft is in threaded engagement with the housing, the slip clutch enable the transmission of torque from the knob to the shaft to allow the incremental axial movement of piston if the pressure of the medium within the housing is at or below a predetermined maximum allowable value. However, if the pressure of the medium exceeds the predetermined maximum value, the frictional elements within the slip clutch slip relative to each other and prevent the transmission of torque from the knob to the shaft, and thus any further pressurization of the fluid medium.

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Waltham, MA, United States of America

Richard T Choh