Delivery of Agents Such as Cells to Tissue

• US 20080294096A1
• Filed: 11/06/2006
• Published: 11/27/2008
• Est. Priority Date: 11/04/2005
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Trocki, Mark, Rhinehart, Edward J., Uber, Arthur E. III, Parks, Robert, Cowan, Kevin P., Reilly, David M., Griffiths, David M., Hirschman, Alan D., Gelblum, Eugene A., Tucker, Barry L., Cedarholm, Page, Mishler, David, Bartony, Henry E. JR., Facher, Evan
• Granted Patent: US 8,182,444 B2
• Time in Patent Office: Days
• US Class Current: 604/66
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/009 the needle having a bent tip, i.e. the needle distal tip is angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2025/0092 Single injection needle protruding laterally from the distal tip
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 31/005 for contrast media
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings

Abstract

A system for delivering a fluid comprising cells to tissue of a patient, includes: a least a first container for holding an injection fluid in which the agent is carried; a first powered drive in operative connection with the container, the first powered drive being operable to pressurize contents of the container; a control system in operative connection with the first powered drive and operative to control the first powered drive; a fluid path in fluid connection with the container, the fluid path including a patient interface adapted to deposit the cells within tissue of the patient; a sensor system; and a communication system in connection with at least the control system and the sensor system. The communication system is adapted to provide information to the control system. The control system in adapted to transmit a control signal to at least the first powered drive based at least in part on information provided to the control system. The cells can for example be pregenitor cells or stem cells.

Claims

1. A system for delivering a fluid comprising cells to tissue of a patient, comprising:

at least a first container for holding an injection fluid in which the agent is carried;

a first powered drive in operative connection with the container, the first powered drive being operable to pressurize contents of the container;

a control system in operative connection with the first powered drive and operative to control the first powered drive;

a fluid path in fluid connection with the container, the fluid path including a patient interface adapted to deposit the cells within tissue of the patient;

a sensor system; and

a communication system in connection with at least the control system and the sensor system, the communication system being adapted to provide information to the control system, the control system being adapted to transmit a control signal to at least the first powered drive based at least in part on information provided to the control system.

2. The sensor system of claim 1 wherein the sensor system comprises at least one tissue sensor system to measure a property of the tissue and at least one fluid sensor system to measure a property of the fluid to be delivered.

3. The sensor system of claim 1 wherein the sensor system comprises at least one cell health sensor system to measure the health of the cells.

20-117. -117. (canceled)

118. A system for delivering a fluid including cells to tissue of a patient, comprising:

at least a first container for holding an injection fluid in which the cells are carried;

a first powered drive in operative connection with the container, the first powered drive being operable to pressurize contents of the container;

a control system in operative connection with the first powered drive and operative to control the first powered drive;

a fluid path in fluid connection with the container, the fluid path including a patient interface adapted to deposit the cells within tissue of the patient;

a sensor system comprising at least one cell sensor system to measure a property indicative of the health of the cells; and

a communication system in connection with at least the control system and the sensor system, the sensor system being adapted to provide information to the control system, the control system being adapted to transmit a control signal to the first powered drive based at least in part on information provided to the control system.

4. The sensor system of claim 118 wherein the cell health sensor system measures at least one of presence of at least one nutrients, atmosphere, temperature, pressure, cell integrity, cell death, cell count, chemical labeling, conductivity, optical fluorescence, optical scattering, at least one cell biomarkers, DNA content, optical density, UV spectroscopy, IR spectroscopy, at least one metabolic variable, at least one cell culture biomarker, at least one genetic identification, cell apoptosis, or cell senescence.

5. The sensor system of claim 118 wherein the control system is adapted to transmit a control signal to the first powered drive based at least in part on the measure of health of the cells from the cell health sensor system.

6. The system of claim 118 wherein the cells are stem cells.

7. The system of claim 118 wherein the system further comprises a cell maintenance system being adapted to affect at least one property of at least one of the injection fluid or the cells.

8. The system of claim 7 wherein the sensor system including at least one sensor in operative connection with the maintenance system to measure the value of the at least one property of the fluid or the cells.

9. The system of claim 8 wherein the controller system is adapted to transmit a control signal based at least in part on the measured value of the measured property.

10. The system of claim 7 wherein the cell maintenance system is in operative connection with the container.

11. The system of claim 7 wherein the cell maintenance system is in operative connection with the patient interface.

12. The system of claim 7 further comprising a cell processing system.

13. The system of claim 118 wherein the sensor system further comprises at least one patient sensor system adapted to measure at least one physiological property of the patient, the communication system being in connection with the patient sensor system to provide information of the measured physiological property of the patient to the controller system, the controller system being adapted to transmit a control signal based at least in part on the measured physiological property of the patient.

14. The system of claim 13 wherein the value of the physiological property of the patient is processed by the control system to transmit a signal to the first powered drive to time an injection.

15. The system of claim 14 wherein the physiological property of the patient is the position of a beating heart of the patient or a phase of a beating heart.

16. The system of claim 13 wherein the physiological property of the patient is processed by the controller to transmit a signal to the first powered drive to alter an injection protocol.

17. The system of claim 13 wherein the at least one property of the patient is related to mapping of a heart, characterization of tissue of a heart, characterization of a systolic or diastolic phase of a heart, a dynamic position of any portion of a beating heart, brain function, presence or absence of a neurotransmitter (for example, dopamine), EEG characterization, characterization of brain tissue (for example, determination of the presence of ischemic tissue associated with stroke), pancreatic function, presence or absence of hormone (for example, insulin) or islet cell function.

18. The system of claim 118 further comprising an imaging system adapted to image a region of the patient to which the cells are delivered.

19. The system of claim 18 wherein the communication system is in connection with the imaging system to provide information of a measured property from the imaging system to the control system, the control system being adapted to transmit a control signal based at least in part on the measured property from the imaging system.

119. A system of claim 118 wherein the at least one cell sensor system is adapted to measure cell viability.

120. A system of claim 118 wherein the at least one cell sensor system is adapted to measure at least one of cell count, cell viability, temperature, pH, concentration, pressure or flow rate.

121. A system for delivering a fluid including an agent to tissue of a patient, comprising:

at least a first container for holding an injection fluid in which the agent is carried;

a first powered drive in operative connection with the container, the first powered drive being operable to pressurize contents of the container;

a control system in operative connection with the first powered drive and operative to control the first powered drive;

a fluid path in fluid connection with the container, the fluid path including a patient interface adapted to deposit the cells within tissue of the patient;

a sensor system comprising at least one tissue sensor system to measure a property of the tissue and at least one fluid sensor system to measure a property of the fluid to be delivered; and

a communication system in connection with at least the control system and the sensor system, the sensor system being adapted to provide information to the control system, the control system being adapted to transmit a control signal to the first powered drive based at least in part on information provided to the control system.