Coronary vasculature treatment method

• US 5,681,278 A
• Filed: 06/23/1994
• Issued: 10/28/1997
• Est. Priority Date: 06/23/1994
• Status: Expired due to Fees

• Current Assignee: Cormedics Corp.
• Original Assignee: Cormedics Corp.
• Inventors: Meador, James W., Igo, Stephen R.
• Primary Examiner(s): McDermott, Corrine M.
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/264,458
• Time in Patent Office: 1,223 Days
• Field of Search: 604/890.1, 604/891.1, 604/19, 604/20, 604/21, 604/51, 604/93, 604/49, 604/52, 604/53, 604/23, 604/26, 128/898
• US Class Current: 604/507
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2210/122 Pericardium
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: A61P 9/14 Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers

Abstract

Method and apparatus for treating blood vessels in a mammal, particularly humans, especially coronary blood vessels, for vascular thrombosis and angioplasty restenosis, thereby to decrease incidence of vessel rethrombosis, unstable angina and myocardial infarction, by administering a conager of an endothelium-derived bioactive agent, especially a nitrovasodilator, including one or more of nitric oxide or a nitric oxide donor agent, such as sodium nitroprusside and nitroglycerin, to an extravascular treatment site at a therapeutically effective dosage rate.

Claims

1. The method of treating a mammal comprising the steps of:

(a) selecting a congener of an endothelium-derived bioactive agent;

(b) administering a therapeutically effective dosage of the selected congener to a site proximately adjacent the exterior of a coronary blood vessel; and

(c) allowing the congener to treat the coronary blood vessel from the outside-in.

2. The method of claim 1 in which said step of selecting further comprises selecting sodium nitroprusside as said congener.

3. The method of claim 1 in which said coronary blood vessel is a coronary artery.

4. The method of claim 1 in which said coronary blood vessel is a vein graft for arterial bypass.

5. The method of claim 1 in which said step of administering includes delivering said congener in a controlled manner over a sustained period of time.

6. The method of claim 1 in which said step of administering comprises administering a dosage rate of said selected congener effective to provide one or more of the therapeutic effects of promotion of vasodilation, inhibition of vessel spasm, inhibition of platelet aggregation, inhibition of vessel thrombosis, and inhibition of platelet growth factor release, at said treatment sites, without inducing systemic hypotension or anticoagulation.

7. The method of claim 1 in which said step of administering comprises administering a dosage rate of from about 0.1 to about 3.0 μ

g/kg/min of said selected congener.

8. The method of claim 1 in which said step of administering comprises intrapericardially extravascularly delivering said congener to said coronary blood vessel.

9. The method of claim 8 in which said step of administering comprises intrapericardially infusing said congener through a percutaneously inserted catheter extravascularly to said coronary blood vessel.

10. The method of claim 1 in which said step of selecting further comprises selecting said congener from the group consisting of prostacyclin, prostaglandin E₁, or a nitrovasodilator, or a combination thereof.

11. The method of claim 10 in which said step of selecting further comprises selecting said nitrovasodilator from the group consisting of nitric oxide, a nitric oxide donor agent, or a combination thereof.

12. The method of claim 11 in which said step of selecting further comprises selecting said nitric oxide donor agent from the group consisting of L-arginine, sodium nitroprusside, nitroglycerin, or a combination thereof.

13. The method of claim 1 in which said step of administering comprises transpericardially extravascularly delivering said congener to said coronary blood vessel.

14. The method of claim 13 in which said step of administering comprises transpericardially infusing said congener through a percutaneously inserted catheter extravascularly to said coronary blood vessel.

15. The method of claim 13 in which said step of administering comprises iontophoretically delivering said congener transpericardially extravascularly to said coronary blood vessel.

16. The method of claim 1 in which said step of administering comprises inserting extravascularly to said coronary blood vessel an implant capable of extended time release of said congener.

17. The method of claim 16 in which said step of inserting said extravascular implant comprises percutaneously inserting said implant proximately adjacent, onto, or into the pericardial sac surrounding the heart.

18. The method of claim 16 in which step of inserting said extravascular implant comprises surgically wrapping said implant around a vein graft used for an arterial bypass.

19. The method of claim 16 in which said step of inserting said implant further comprises inserting a biodegradable controlled-release polymer comprising said congener.

20. A method of treating a coronary blood vessel in a mammal, which comprises intrapericardially or transpericardially supplying sodium nitroprusside to the blood vessel in a therapeutically effective dose.

21. A method of treating a coronary blood vessel in a mammal, which comprises intrapericardially or transpericardially extravascularly delivering a congener of an endothelium-derived bioactive agent of said blood vessel at a therapeutically effective dosage rate.