Georgia Tech Research Corporation

Cell Precision, LLC

Other

Raymond P Vito

Jack C Griffis, Iii

Michael L Wach

W Robert Taylor

H Russell Boehm

Jack Griffis

Delivery devices, systems, and methods are configured to enhance retention of a therapeutic agent delivered at a treatment site, for example, via impeding agent backflow. A device may include sheath having a first end, a second end, and a length between the first end and the second end. The sheath may include an outer diameter and an inner channel between the first end and the second end, and at least one penetrating member configured to form a channel at the treatment site. The device may include an elongate member having a first end, a second end, and a length between the first end and the second end, the elongate member being configured to move relative to the sheath. The elongate member may be configured to control the movement of the penetrating member with respect to the sheath.

Delivery devices, systems and methods for delivering therapeutic agents

A medical practitioner can specify certain parameters for a procedure that involves delivering a therapeutic agent, while leaving other parameters open. The therapeutic agent can be sensitive to biomechanical forces (or other influences) associated with delivery. The procedure can involve regenerative medicine, for example delivering progenitor or stem cells to a diseased heart using a catheter, whereby unbridled transport in the catheter may compromise efficacy. The open parameters can influence efficacy of the agent and thus therapeutic outcome. A computer-based system can apply stored information, such as from databases, to narrow the possible values of the open parameters. From the narrowed possibilities, an optimization routine can determine suitable or optimized values for the open parameters. The determined values can manage biomechanical forces incurred by the therapeutic agent, thereby promoting efficacy and healing. The optimized parameters can guide the practitioner in the procedure.

Guided delivery of cell, particle, and drug based therapies

Method and system for mitigating effects of biomechanical forces on cell, particle and drug based therapies

A catheter for delivering a therapeutic agent to a target site of a human or animal subject can include a substantially flexible and biocompatible catheter body having a proximal end and a distal end. An eductor can be located at the distal end of the catheter body, and a first lumen within the catheter body for housing the therapeutic agent can be in fluid communication with the eductor. A second lumen, also in fluid communication with the first lumen, can extend from the proximal end of the catheter body towards the eductor and can have an output port at the distal end of the catheter body. The eductor can be operable to induce the therapeutic agent to flow from the first lumen out of the output port in response to fluid flowing through the second lumen.

System and method for delivering a therapeutic agent with finesse

A physician, nurse, or other healthcare practitioner can deliver a therapeutic agent to a patient in a manner that maintains effectiveness of the therapeutic agent, via monitoring and controlling shear, stress, or other potentially detrimental effect. A gauge, meter, or other monitoring device can provide an indication of shear (or other effect) that the therapeutic agent is experiencing during delivery. The monitoring device can provide information relevant to delivering the therapeutic agent in a manner that maintains effectiveness, thereby guiding the practitioner during delivery. For example, the monitoring device can display an estimate of shear based on sensing flow rate or pressure. The therapeutic agent can comprise one or more therapeutic cells, such as progenitor cells or stem cells, or some other healing substance delivered via a cardiac catheter to the patient's cardiovascular tissue, for example.

Monitoring stress on a therapeutic agent during patient delivery

Intravascular devices are provided for forming a vascular graft by axially distending a blood vessel to induce growth. These devices advantageously can be implanted via a catheter, thereby eliminating the need for a more invasive implantation procedure when the stretching is to be done in vivo. The implantable medical device for distending a blood vessel to induce axial growth of the blood vessel includes an intravascular stretching mechanism securable to an interior luminal surface of a blood vessel in vivo, and a means for operating the intravascular stretching mechanism in vivo to cause the vessel to stretch and grow axially. The stretching mechanism can include a pair of wires or stents that engage the blood vessel wall, and components of the stretching mechanism may include a shape memory material.

Intravascular device for axially stretching blood vessels

Intravascular devices and methods are provided for forming a vascular graft by axially distending a blood vessel to induce growth. These devices advantageously can be implanted via a catheter, thereby eliminating the need for a more invasive implantation procedure when the stretching is to be done in vivo. Preferably, the device for axially distending a blood vessel to induce growth of the vessel includes an intravascular stretching mechanism attachable directly to an interior lumen portion of the blood vessel, and a means for operating the stretching mechanism to cause the vessel to distend axially. The stretching mechanism can include a pair of wires or stents that engage the blood vessel wall. Components of the stretching mechanism can include a shape memory material.

Intravascular device and method for axially stretching blood vessels

Methods and apparatus are provided for forming a vascular graft in vitro by axially distending a blood vessel to induce growth. The apparatus comprises a chamber containing a tissue culture medium, an inlet cannula, an outlet cannula, and a means for moving the inlet cannula, the outlet cannula, or both, to axially stretch a donor blood vessel secured between the inlet cannula and the outlet cannula in a submerged position in the tissue culture medium, wherein the inlet cannula, the outlet cannula, and the donor blood vessel are secured together to form a conduit through which the tissue culture medium can flow.

Device and method for creating a vascular graft in vitro

Devices and methods are provided for forming a vascular graft by axially distending a blood vessel to induce growth. In one embodiment, a device for distending a blood vessel of a human or animal is provided which comprises a stretching mechanism attachable directly to a blood vessel at at least two attachment positions thereon, and a means for operating the stretching mechanism to cause the blood vessel portion between said at least two attachment positions to be stretched axially. The distended portion can then be excised and used as a graft.

Autologous vascular grafts created by vessel distension

Devices and methods are provided for forming a vascular graft by axially distending a blood vessel to induce growth. The device preferably comprises a stretching mechanism which includes (i) a rigid body; (ii) a pair of posts comprising a first post and a second post which are connected to the body; (iii) a driver element slidably secured to the body and disposed between the pair of posts; and (iv) a device for sliding the driver element away from the pair of posts to axially distend a blood vessel positioned between the pair of posts and the driver element. Preferably, the device is implanted, for example using endoscopic techniques, for use in vivo, although the device also can be used in vitro.

Devices for creating vascular grafts by vessel distension using fixed post and moveable driver elements

Devices and methods are provided for forming a vascular graft by axially distending a blood vessel to induce growth. The device preferably comprises a stretching mechanism which includes (i) a stabilization rod, (ii) a pair of rotatable elements, wherein each rotatable element is rotatably attached to the elongated body and has a channel substantially perpendicular to the axis of rotation, and (iii) a means for rotating each rotatable element to axially distend a blood vessel positioned in the channels of the rotatable elements. The elements can be rotated intermittently, cyclically, or continuously, over a period to distend or elongate the donor vessel. Preferably, the device is implanted, for example using endoscopic techniques, for use in vivo, although the device also can be used in vitro.

Devices for creating vascular grafts by vessel distension using rotatable elements

A method is provided for forming an autologous graft by distending a donor blood vessel and harvesting the distended portion of the vessel. Also provided is a device for in vivo or in vitro vessel distension. Typically the device is implanted, for example using endoscopic techniques, in a patient sometime prior to another surgery on that patient which includes implanting a vascular graft. The device includes a stretching mechanism which is attached to a donor blood vessel, means for operating the stretching mechanism to cause the vessel to distend, and a controller, preferably externally located, for controlling the operating means. In a preferred embodiment, the device includes a pair of opposed straps, attached to a healthy, small-diameter donor blood vessel such as a femoral artery in the leg. The straps are displaced from each other over a period of time to continuously distend or elongate the donor vessel. The distended portion of the donor vessel is excised at the time of the bypass surgery. The ends of the donor vessel are then sutured end to end to repair the donor vessel, a procedure common in vascular repair and generally accomplished without complication. The result is a totally autologous, living vascular graft.

An improved fixation assembly for orthopedic applications. The fixation assembly includes a screw having an upper shank portion, a middle section with a recessed area, and a lower threaded section. A locking ring surrounds the recessed area of the screw, with the diameter of the locking ring being greater than the diameter of the recessed area of said screw and less than the diameter of the shank and threaded sections of the screw. The screw and locking ring combination is used to attach an orthopedic plate to a bone. The orthopedic plate includes a hole for receiving the screw and the locking ring. The hole includes an upper section and a lower section, wherein the width of the upper section is less than the width of the locking ring so that the locking ring is compressed while in the upper section of the hole. The width of the lower section is greater than the width of the locking ring so that the locking ring is not compressed while in the lower section of the hole.

Fixation assembly for orthopedic applications

The modular components of an orthopedic leg brace assembly are secured together around a flexible cable arrangement and the components are removable so that they may be dissambled for repair or for replacement with longer components to accommodate for a user's growth. The components inlcude an ankle-foot orthosis and upwardly extending side braces of stanchion form with an upper securing strap arrangement for securely surrounding a user's lower leg, a second pair of side braces of stanchion form with an upper securing strap arrangement for securely surrounding a user's thigh, and knee joint assemblies joining the ends of the braces to simulate the normal action of a user's knee during flexion and extension of the leg. The flexible cable arrangement allows the user to rigidly hold the entire unit in aligned, fixed relation when the leg is extended.

Orthopedic leg brace with cable control

The modular components of an orthopedic leg brace assembly are strung together in bead-like fashion on a flexible cable arrangement and the components are removable so that they may be unstrung and replaced for repair or for replacement with longer components to accommodate for a user's growth. The components include an ankle-foot orthosis and upwardly extending side braces of stanchion form with an upper securing strap arrangement for securely surrounding a user's lower leg, a second pair of side braces of stanchion form with an upper securing strap arrangement for securely surrounding a user's thigh, and knee joint assemblies joining the ends of the braces to simulate the normal action of a user's knee during flexion and extension of the leg. The flexible cable arrangement allows the user to rigidly hold the entire unit in aligned, fixed relation when the leg is extended.

Growing community of inventors

Atlanta, GA, United States of America

Raymond P Vito