Claims
- 1. A method for the volumetric distribution of a pharmaceutical agent in the tissue of a living vertebrate host, said method comprising:
positioning a needle through the wall of a target blood vessel so that an aperture of the needle is positioned beyond an external elastic lamina (EEL) of the wall by a distance not exceeding 5 mm; and delivering an amount of the pharmaceutical agent from the aperture so that the agent distributes both longitudinally and radially from the injection site.
- 2. A method as set in claim 1, wherein the agent distributes longitudinally along the blood vessel over a distance of at least 1 cm and radially by a distance of at least 1 cm or within a time period no greater than 60 minutes.
- 3. A method as in claim 2, wherein the concentrations of agent at all locations spaced at least 2 cm from the delivery site are at least 10° of the concentration at the delivery site.
- 4. A method as in claim 1, wherein the agent distributes via the lymphatic system surrounding the target.
- 5. A method as in claim 1, wherein the aperture of the needle is positioned at a distance less than 5 mm beyond the EEL.
- 6. A method as in claim 5, wherein pharmaceutical agent comprises a small molecule drug, a protein, or a gene.
- 7. A method as in claim 6, wherein the agent has a maximum dimension of 200 nm or below.
- 8. A method as in claim 1, wherein the blood vessel is a coronary blood vessel.
- 9. A method as in claim 6, wherein the coronary blood vessel is an artery.
- 10. A method as in claim 7, wherein the coronary artery is at risk of hyperplasia.
- 11. A method as in claim 7, wherein the coronary artery has regions of vulnerable plaque.
- 12. A method as in claim 1, wherein the patient is suffering from congestive heart failure or a cardiac arrhythmia.
- 13. A method as in claim 1, wherein the blood vessel is a cerebral blood vessel and the tissue is in the brain of the host.
- 14. A method as in claim 1, wherein the blood vessel is a hepatic blood vessel and the tissue is in the liver of the host.
- 15. A method as in claim 1, wherein the agent is being delivered to treat a neoplastic disease in the tissue.
- 16. A method as in claim 1, further comprising:
confirming that the aperture is positioned beyond the EEL before delivering the amount of pharmaceutical agent.
- 17. An improved method for injecting a pharmaceutical agent into the tissue of a living host using a needle positioned from a lumen of a blood vessel, wherein the improvement comprises positioning the needle outwardly from the blood vessel lumen and confirming that a delivery aperture of the needle has penetrated into tissue beyond an external elastic lamina (EEL) of the blood vessel before injecting the pharmaceutical agent.
- 18. An improved method as in claim 17, wherein confirming comprises injecting contrast media through the needle aperture and observing distribution of the media.
- 19. An improved method as in claim 17, wherein confirming comprises monitoring injection pressure.
- 20. An improved method as in claim 17, wherein confirming comprises monitoring temperature near the delivery aperture.
- 21. An improved method as in claim 17, wherein confirming comprises monitoring pH near he delivery aperture.
- 22. An improved method as in claim 17, wherein confirming comprises monitoring electrical impedance near the delivery aperture.
- 23. An improved method as in claim 17, wherein confirming comprises monitoring insertion force while positioning the needle through the EEL.
- 24. A catheter comprising:
a catheter body; a needle having an aperture and being deployable from the catheter body; and means coupled to the needle for detecting when the aperture of the needle has advanced beyond the external elastic lamina of the blood vessel.
- 25. A catheter as in claim 24, wherein the detecting means comprises a temperature sensor attached to the needle near the aperture.
- 26. A catheter as in claim 24, wherein the detecting means comprises an electrical impedance sensor attached to the needle near the aperture.
- 27. A catheter as in claim 24, wherein the detecting means comprises a pH sensor attached to the needle near the aperture.
- 28. A catheter as in claim 24, wherein the detecting means comprises an insertion force sensor coupled to the needle.
- 29. A kit for delivering a pharmaceutical agent to a patient suffering from or at risk of vascular disease, said kit comprising:
a catheter having a needle which can be advanced from a blood vessel lumen through a wall of the blood vessel to position an aperture of the needle beyond an external elastic lamina (EEL) of the wall by a distance not exceeding 5 mm; and instructions for use setting forth a method comprising: positioning the needle through the wall of the target blood vessel so that the aperture of the needle is positioned beyond the external elastic lamina (EEL) of the wall by a distance not exceeding 5 mm; and delivering an amount of the pharmaceutical agent from the aperture so that the agent distributes both longitudinally and radially from the injection site.
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of application Ser. No. 10/350,314 (Attorney Docket No. 21621-000110US), filed on Jan. 22, 2003, which claimed the benefit of each of the following provisional application 60/350,564, filed Jan. 22, 2002 (Attorney Docket No. 21621-000900); 60/356,670, filed Apr. 5, 2002 (Attorney Docket No. 21621-001000); 60/370,602, filed Apr. 5, 2002 (Attorney Docket No. 21621-000100); and 60/430,993, filed Dec. 3, 2002 (Attorney Docket No. 21621-001300). The full disclosures of each of these prior provisional and non-provisional applications are incorporated herein by reference.
Provisional Applications (4)
|
Number |
Date |
Country |
|
60350564 |
Jan 2002 |
US |
|
60356670 |
Feb 2002 |
US |
|
60370602 |
Apr 2002 |
US |
|
60430993 |
Dec 2002 |
US |
Continuation in Parts (1)
|
Number |
Date |
Country |
Parent |
10350314 |
Jan 2003 |
US |
Child |
10691119 |
Oct 2003 |
US |