Method and system for delivering therapeutic agents

• US 5,865,744 A
• Filed: 09/16/1996
• Issued: 02/02/1999
• Est. Priority Date: 09/16/1996
• Status: Expired due to Term

• Current Assignee: Jerome H. Lemelson
• Original Assignee: Jerome H. Lemelson
• Inventors: Lemelson, Jerome H.
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): SHAW, SHAWNA JEANNINE
• Application Number:
  US08/714,211
• Time in Patent Office: 869 Days
• Field of Search: 128/653.1, 128/920, 128/922, 128/660.03, 606/130, 901/1, 901/2, 901/8, 901/6, 382/153, 382/194, 382/195, 382/128, 378/4, 378/62, 378/205, 600/407, 600/439, 600/437
• US Class Current: 600/407
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00969 used for transplantation
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 34/30 Surgical robots
• CPC Class Codes: A61B 34/70 Manipulators specially adapted for use in surgery
• CPC Class Codes: A61K 35/407 Liver; Hepatocytes
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/31525 Dosing burettes, pipettes B01L3/02
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion
• CPC Class Codes: Y10S 128/922 including image analysis

Abstract

A system and method are disclosed for internally delivering a therapeutic agent to a patient under the automatic control of a computer. A diagnostic imaging modality, such as a CAT or MRI scanning system, generates one or more images of the patient'"'"'s anatomy showing an anatomical region into which it is desired to deliver the cellular transplants. For each such image, location coordinates with respect to a patient support means are calculated by the computer for each individual pixel making up the image. Location coordinates are then defined for a select body region corresponding to pixels of the anatomical image(s) designated by a user of the system to receive the therapeutic agent. The computer then operates a manipulator arm in order to position an injection tool such as an injection needle or catheter mounted on the arm adjacent to the select body region. In the case of an injection needle, the needle is inserted into the region at the appropriate depth, and an injector is operated under computer control to force a predetermined amount of a medium containing the therapeutic agent out of a lumen within the injection needle and into the select body region.

Claims

1. A system for delivering a therapeutic agent to a patient comprising:

a computer;

an injection needle device for delivering a fluid agent into a tissue;

an automatic manipulator including a manipulator arm assembly for supporting and operation said injection needle and a power driving device for moving said manipulator arm along multiple axes;

a patient support structure having a support surface;

a power driven device operable under computer control for moving said support surface and said manipulator arm assembly relative to one another to cause the manipulator arm assembly to controllably move said injection needle into select regions of the patient'"'"'s body;

a scanning system including an imaging device for generating image information of select anatomical regions of the patient'"'"'s body wherein said imaging device includes an ultrasonic pulse-echo transducing means and an actuator for effecting relative movement between said patient support surface and said imaging device which includes a manipulator arm assembly for positioning said ultrasonic transducer under control of said computer;

a plurality of sensors for sensing the relative positions of said patient support, said manipulator arm assembly, and said scanning imaging device, and generating and feeding coded signals representing the sensed positions to said computer;

a first computer program for calculating location coordinates of select body regions defined by pixels of images produced by said scanning imaging device and using the coded signals representing the sensed relative positions of said patient support means and said imaging device; and

a second computer program for calculating location coordinates of said injection needle and determining when said injection needle is located at said select body region into which it is desired to deliver a therapeutic agent.

2. A system in accordance with claim 1 further comprising an electronic display device for displaying images and allowing the designation and inputting to said computer of select pixels of said images that correspond to select regions of the patient'"'"'s body into which it is desired to dispose said injection needle and deliver said therapeutic agent.

3. A system in accordance with claim 1 wherein said scanning system includes a magnetic resonance imaging device.

4. A system in accordance with claim 1 wherein said scanning system includes a computerized axial tomography scanner.

5. A system in accordance with claim 1 further comprising an actuator for effecting relative movement between said patient support and said imaging device under control of said computer.

6. A system in accordance with claim 1 further comprising a program for automatically controlling movement of said manipulator arm assembly so as to cause the insertion of said injection needle into said select body region at a desired depth.

7. A system in accordance with claim 1 further comprising a program for automatically controlling operation of said injector so as to cause it to inject a predetermined amount of said a therapeutic agent into said select body region.

8. A method for internally delivering therapeutic material into a patient, comprising the steps of:

supporting a patient on a patient support which is relatively movable with respect to an injection tool mounted on a computer controlled manipulator arm to permit the tool to be inserted into select regions of the patient'"'"'s body under control of a computer wherein said injection tool comprises an injection needle having a conduit therein for flowing a fluid medium containing a therapeutic agent into tissue in which the needle is inserted and an injector for forcing the medium through said conduit;

scanning a select portion of the patient'"'"'s body with a scanning device so as to generate scanning information relating to select regions of the patient'"'"'s body;

sensing the relative positions of said patient support, said injection tool, and said scanning imaging device, and generating and feeding coded signals representing the sensed positions to a computer in digitized form;

operating the computer to calculate location coordinates of a select body region requiring treatment and defined by select pixels making of the images produced by said scanning imaging device, using the coded signals to predeterminately and relatively position of said patient support means and said scanning device;

designating and inputting to a computer information defining select pixels of images produced by said scanning device which information represents select regions of the patient'"'"'s body to which it is desired to deliver select therapeutic material;

calculating location coordinates of said injection device and determining if an operating end of said injection tool is properly located at a select body region into which it is desired to deliver said therapeutic material; and

, when so located,

operating said injection tool to deliver a select amount of said therapeutic material into said select body region and injecting a medicinal agent into said select body region through a second conduit extending through said injection needle.

9. A method in accordance with claim 8 wherein said imaging device and said patient support are relatively movable with respect to each other, said method further comprising the step of selectively positioning said scanning device under computer control so as cause it to generate images of select portions of the patient'"'"'s body.

10. A method in accordance with claim 8 wherein said injection tool is a catheter having an outflow port for delivering material to an intraductal or other internal body site into which the catheter is inserted.

11. A method in accordance with claim 8 further comprising the steps of automatically moving said injection tool under control of said computer until said injection device is inserted into tissue of said select body region into which select tissue it is desired to deliver said therapeutic material and automatically injecting a select amount of said medium therein.

12. A method in accordance with claim 11 further comprising the step of computer controlling the amount of therapeutic material injected into said select body region.

13. A method in accordance with claim 8 wherein said therapeutic material comprises cellular hepatocytes.

14. A method in accordance with claim 13 wherein said hepatocytes are injected into the patient'"'"'s spleen.

15. A method in accordance with claim 13 wherein said hepatocytes are injected into a branch of the patient'"'"'s portal vein.

16. A system for delivering a therapeutic agent to a patient comprising:

a computer;

an injector assembly comprising an injection needle having a conduit therein for flowing a fluid into tissue in which the needle is inserted and an injector for forcing, a therapeutic agent through said conduit wherein said therapeutic agent is a transplant medium containing cellular transplants;

an automatic manipulator including a manipulator arm assembly for supporting and operating said injection needle and a power driving device for moving said manipulator arm along multiple axes;

a patient support structure having a support surface;

a power driven device operable under computer control for moving said support surface and said manipulator arm assembly relative to one another to cause the manipulator arm assembly to controllably move said injection needle into select regions of the patient'"'"'s body;

a scanning system including an imaging device for generating image information of select anatomical regions of the patient'"'"'s body;

a plurality of sensors for sensing the relative positions of said patient support, said manipulator arm assembly, and said scanning imaging device, and generating and feeding coded signals representing the sensed positions to said computer;

a first computer program for calculating location coordinates of select body regions defined by pixels of images produced by said scanning imaging device and using the coded signals representing the sensed relative positions of said patient support means and said imaging device; and

a second computer program for calculating location coordinates of said injection needle and determining when said injection needle is located at said select body region into which it is desired to deliver a therapeutic agent.