Abstract: The present invention provides an access device for surgery. The access device includes a guide member and a head member. The guide member and head member define a channel configured to receive and guide a sterile flexible scope with a working channel. The guide member and head member cooperate to extend through a small opening of 2 cm or less to access tissue structures. The head member may include surfaces to separate a pericardium from a surface of the heart, stabilize a beating heart and, with the endoscope, provide visibility for the implantation of a therapeutic such as stem cells to the surface of the heart with improved safety and accuracy. Ranges of other diagnostic, application of therapeutics or biologics, and observational applications may be facilitated by the access device, such as TMR, ablation, echo-probe diagnostics, LAA isolation, observation of the same procedures, etc.

Abstract: The present invention provides an access device for surgery. The access device includes a guide member and a head member. The guide member and head member define a channel configured to receive and guide a sterile flexible scope with a working channel. The guide member and head member cooperate to extend through a small opening of 2 cm or less to access tissue structures. The head member may include surfaces to separate a pericardium from a surface of the heart, stabilize a beating heart and, with the endoscope, provide visibility for the implantation of a therapeutic such as stem cells to the surface of the heart with improved safety and accuracy. Ranges of other diagnostic, application of therapeutics or biologics, and observational applications may be facilitated by the access device, such as TMR, ablation, echo-probe diagnostics, LAA isolation, observation of the same procedures, etc.

Abstract: Methods, systems, and apparatus, for data management and access for drug and procedural testing. In one aspect, a method includes receiving dynamic trial data for an ongoing trial from a trial site, associating the dynamic trial data with a corresponding ongoing trial, storing the dynamic trial data for the ongoing trial in a data store, receiving a request to access the trial data for an ongoing trial and receiving sponsor credentials associated with the request, the sponsor credentials identifying a sponsor that provided the request, determining that the sponsor identified by the request is the sponsor of the ongoing trial for which the access to the trial data is requested, and in response to the determination, providing access to the trial data in response to the request, the access to the trial data including access to the dynamic trial data for the ongoing trial.

Abstract: An apparatus for treating a patient. The apparatus includes a catheter having a distal end and a proximal end. The distal end has an orifice through which a fluid can flow. The distal end has a port through which the fluid can flow. The port is adjacent to but apart from the orifice. The apparatus includes a mechanism for controlling the size of the port that is open. The controlling mechanism is disposed over the port and able to close the port. An apparatus for treating a patient. The apparatus includes a catheter having a proximal end and a distal end having an orifice through which a fluid can flow. The distal end has an end marker disposed about the orifice which appears in an image of an imaging device. An apparatus for treating a patient. The apparatus includes a catheter having a proximal end and a distal end having an orifice through which fluid can flow. The catheter has an axis.

Abstract: An apparatus for treating a patient. The apparatus includes a catheter having a distal end and a proximal end. The distal end has an orifice through which a fluid can flow. The distal end has a port through which the fluid can flow. The port is adjacent to but apart from the orifice. The apparatus includes a mechanism for controlling the size of the port that is open. The controlling mechanism is disposed over the port and able to close the port. An apparatus for treating a patient. The apparatus includes a catheter having a proximal end and a distal end having an orifice through which a fluid can flow. The distal end has an end marker disposed about the orifice which appears in an image of an imaging device. An apparatus for treating a patient. The apparatus includes a catheter having a proximal end and a distal end having an orifice through which fluid can flow. The catheter has an axis.

Abstract: An apparatus for treating a patient. The apparatus includes a catheter having a distal end and a proximal end. The distal end has an orifice through which a fluid can flow. The distal end has a port through which the fluid can flow. The port is adjacent to but apart from the orifice. The apparatus includes a mechanism for controlling the size of the port that is open. The controlling mechanism is disposed over the port and able to close the port. An apparatus for treating a patient. The apparatus includes a catheter having a proximal end and a distal end having an orifice through which a fluid can flow. The distal end has an end marker disposed about the orifice which appears in an image of an imaging device. An apparatus for treating a patient. The apparatus includes a catheter having a proximal end and a distal end having an orifice through which fluid can flow. The catheter has an axis.

Abstract: A tissue compression shield can help minimize trauma to tissue during surgical retraction. One such shield has a shell having a rigid outer surface adapted to abut a surgical retractor and a concave inner surface defining an elongate tissue-receiving channel. The concave inner surface is adapted to deform under localized pressure to increase surface area in contact with tissue within the channel, thereby more widely distributing pressure across the tissue. If so desired, the shield can include a compressible inner pad that contacts the tissue. In an alternative design, a shield employs a shell including a central body and a pair of opposed legs defining therebetween an elongate tissue-receiving channel. An upper one of the legs has a notch along an outer edge thereof which defines a bone-seating recess which is smaller than the tissue-receiving channel.