Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: Devices and methods for delivering therapeutic agents use a movable sheath member to deliver a therapeutic agent with little or no shear stress. The delivery device may include an outer body being configured to move away from a distal end of the delivery device. The movable sheath member may have a first section and a second section opposing the first section, the second section being configured to hold the therapeutic agent. The movable sheath may be configured to deliver the therapeutic agent by increasing the first section by moving the outer body away from the distal end.

Abstract: Delivery devices, systems, and methods are configured to increase the retention of the therapeutic agent, and thereby increase the dose of the agent delivered. The delivery device may include a delivery body and a retractable member configured to move with respect to the delivery body. The retractable member may include a puncture member configured to create a delivery channel at the treatment site. The body may include an opening through which an agent may be delivered after the retractable member has been retracted within the device.

Abstract: Devices and methods for delivering therapeutic agents use an inverted member to deliver a therapeutic agent with little or no shear stress. The inverted member may have a movable continuous surface, the movable continuous surface having a first section and a second section opposing the first section, the second section surrounding an inner cavity that is configured to hold the therapeutic agent, the inverting member being configured to deliver the therapeutic agent by inverting at least a portion of the second section.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: The present invention relates to systems and methods for tissue engineering. In particular, the invention is directed toward systems and methods for conditioning tubular biological structures. For example, an aspect of the present invention comprises systems and methods for uncoupling local mechanical parameters (e.g., circumferential stress, shear stress, and axial stress) from global mechanical parameters (e.g. lumen pressure, flow rate of perfusate, and longitudinal stretch of the construct) to control of local mechanical parameters for conditioning a tubular biological construct.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.