C. R. Bard, Inc.

Medtronic Ave, Inc.

Atrium Medical Corporation

Stephen J Forcucci

Richard A Gambale

Richard T Choh

Michael F Weiser

Sean Forde

Chirag B Shah

Robert L Cafferata

Matthew J Finch

John R Fagan

Edward I Mcnamara

Theodore Karwoski

Nicholas Want

Scott Edward Corbeil

Christopher J Magnin

Kellywan Kan

Mike Weiser

Hiroatsu Sugimoto

Christopher Magnin

Carol A Devellian

The present invention provides a system for delivering a therapeutic agent into tissue in combination with an implant device (). Preferably the therapeutic substance is contained within a pellet form () that is deliverable into the interior of the device () after it has been implanted. In a preferred embodiment the implant device () comprises a flexible coiled spring body, the coils () of which have the proper diameter and spacing to contain the pellet () within the interior of the device () to contact the therapeutic agent. In treatment of ischemic tissue such as that of the myocardium of the heart, the mechanical irritation of the tissue caused by the implanted device () can help to provide an angiogenic effect. Additionally, the cavity () provided by the interior of the device () permits blood to pool around the pellet () and mix with the therapeutic agent. Several delivery systems have provided for delivering the implant and pellet () sequentially or simultaneously.

Agent delivery systems

A valve for use in a chest drainage device is disclosed, the chest drainage device is adapted to receive liquid and air from a patient's chest cavity via an inlet and to permit air to escape through an outlet for air to leave the chest drain, the inlet and outlet define a flow path and the valve is disposed along the flow path. The valve has a valve element that separates an upstream chamber from a downstream chamber and has a first and second sealing surface that are opposed so that when the first and second sealing surfaces are in contact, air pressure below a predetermined value will be prevented from moving from the downstream location to the upstream location. The valve element allows air to move from the upstream chamber to the downstream chamber at a low pressure differential. A pressure relief actuating element is disposed in the valve and located adjacent the valve element such that when the predetermined sub-atmospheric pressure limit between the upstream side and the downstream side is reached or exceeded, the valve element deforms and contacts the pressure relief actuating element such that the post causes the first and second sealing surfaces to partially separate and reduce the pressure differential.

Valve for use with chest drainage system

The present invention provides anchoring mechanisms for tissue implants. The anchors are integrated as part of the structure of the implant and serve to resist migration of the implant from highly dynamic muscle tissue such as the myocardium of the heart. In implant devices configured as a flexible coil, various attributes of the coil may be altered to increase the anchoring capability of the device. The flexibility of the device may be increased to resist migration by changing the coil filament thickness, pitch or filament material. Alternatively, the end coil may be altered to have a broader cross-sectional profile in engagement with the tissue or may include an anchoring barb. Additionally, methods of implanting a tissue implant device are provided.

Implant anchor systems

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

The present invention provides a system for delivering a therapeutic agent in combination with an implanted device to maximize a therapeutic benefit offered by each. Preferably, the therapeutic agent is contained within a solid matrix form such as a pellet or gel to facilitate its handling, and to regulate its rate of dissipation into the tissue after delivery. The implant device is specially configured to receive retain the matrix but permit blood to interact with the matrix so that the agent can be released to the blood in, around the device, and the surrounding tissue. A delivery system comprises an implant delivery device having an obturator capable of piercing the tissue and an agent matrix delivery device to place a matrix form, such as a pellet, into the interior of the implant after it has been implanted. Preferably, the implant delivery device and the matrix delivery device are contained in one apparatus to facilitate delivery of the pellet into the embedded implant. The present invention is useful for treating tissue in any area of the body, especially ischemic tissue experiencing reduced blood flow. The present devices and methods are especially useful for treatment of ischemia of the myocardium. In treatment of the myocardium, the present implant device and matrix combination may be delivered surgically through the epicardium of the heart.

Implant and agent delivery device

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 invention includes systems and methods for stimulating intramuscular angiogenesis by placing a biocompatible device within the tissue of a muscle. The biocompatible device is dimensionally adapted for placement within the tissue of a muscle. Placement of the biocompatible device within the muscle can take place according to the method of the invention by using techniques familiar to those of ordinary skill in the art. Illustrative techniques for placement of the device within the myocardium comprise one practice of the method of the invention.

Systems and methods for imbedded intramuscular implants

The present invention provides a catheter positioning system which serves to control and stabilize a distal end of a catheter at a treatment site within a patient so that a medical procedure can be performed with accuracy. Generally, the positioning system operates by providing a deformable mechanical members at the distal end of the catheter which can be operated from the proximal end of the catheter to extend radially outward to engage surrounding tissue adjacent to treatment site. In one embodiment of the invention a flexible superstructure comprising the plurality of flexible veins extending longitudinally along the distal end of the catheter can be deformed to bow radially outward to engage surrounding tissue. The distal tip of the catheter joined to one of the veins was correspondingly displaced or rotated angularly as the veins bow outward. In another embodiment radially projecting fingers are joined to the distal end of the catheter, which remain retracted during navigation of the catheter to the treatment site then are extended outward to penetrate the tissue and secure the catheter at the treatment site upon being actuated from the proximal end of the catheter by a physician. Methods of positioning a catheter are also disclosed. The inventive device and method are particularly useful in catheter based procedures carried out in large body lumens or in cavities of body organs. In particular, the invention may be useful in delivering implants percutaneously through the left ventricle into the myocardium of the heart.

Catheter positioning systems

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

The present invention provides a device and method for delivering a therapeutic substance to a treatment site within a patient such as a vessel that has undergone angioplasty. The device provides flexible conduits placed together in the vessel along with a shaft that is attached to their distal ends. After being navigated to the treatment site, the shaft may be moved relative to the conduits causing them to buckle and bow radially outward into contact with the tissue to be treated. The therapeutic substance is then pressurized to be delivered through perfusion ports along the distal portion of the conduits. Because the conduits can be expanded into contact with the treatment site without the assistance of an inflatable member, blood flow through the region during delivery of the therapeutic substance is not interrupted in any significant way. Alternatively, the present invention may be used in conjunction with a balloon angioplasty catheter to deliver therapeutic substances after the dilatation procedure. As with the first embodiment, the delivery conduits may be expanded independently from the dilatation balloon so that blood flow will not be interrupted during delivery of the therapeutic substance.

Growing community of inventors

Medford, MA, United States of America

Stephen J Forcucci