Kit for preventing or treating arterial dysfunction resulting from angioplasty procedures

• US 4,955,878 A
• Filed: 12/08/1988
• Issued: 09/11/1990
• Est. Priority Date: 04/04/1986
• Status: Expired due to Term

• Current Assignee: David Summers, Endovasc Ltd., Inc., Spheres Research Partners
• Original Assignee: Biotechnology LLC
• Inventors: Shell, William E., See, Jackie R.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Polatta, Mark O.
• Application Number:
  US07/281,430
• Time in Patent Office: 642 Days
• Field of Search: 604/181, 604/48, 604/50, 514/573, 600/1, 600/3, 600/4
• US Class Current: 604/181
• CPC Class Codes: A61K 31/557 Eicosanoids, e.g. leukotrienes or prostaglandins
• CPC Class Codes: A61K 49/04 X-ray contrast preparations

Abstract

A kit for preventing or treating arterial dysfunction resulting from an angioplasty procedure and particularly, in myocardial angioplasty procedures in human beings. The kit provides the materials necessary to introduce a selected amount of an intraarterial prostaglandin compound into an artery, such as a coronary artery, in which an angioplasty procedure is to occur and an intravenous prostaglandin compound. The prostaglandin compound will provide cyto-protection and provide antithrombotic effects and antiplatelet effects and antispasmatic effects. A composition is also provided for reducing dysfunction in angioplasty procedures and comprises a selected amount of a carrier and a prostaglandin compound carried in a specified amount and which carrier does not alter the prostaglandin compound and releases the prostaglandin compound at a rate sufficient to dilate blood vessels to thereby produce the required efficacy. The kit is a prepackaged combination of components which provides for the complete administration of the prostaglandin compound before, during and after the angioplasty procedure.

Claims

1. A kit containing a combination of components for preventing or treating arterial dysfunction resulting from angioplasty procedures, said kit containing:

(a) a first container comprising about 25 to about 200 nanograms of a prostaglandin E₁ or a prostaglandin pharmacologically equivalent thereto for bolus injection into an artery of a patient;

(b) a second container comprising a prostaglandin E₁ or a prostaglandin pharmacologically equivalent thereto for intravenous administration after said bolus injection sufficient to provide 10 to about 100 nanograms per kilogram of body weight per minute over at least a 6 hour period;

(c) a chart cross-referencing an amount of said prostaglandin from said second container to body weights to be admixed with a saline solution to prepare a dosage amount of about 10 nanograms to about 100 nanograms per kilogram of body weight per minute.

2. The kit of claim 1 which additionally includes a sealed package of saline solution for preparing said intravenous administration.

3. The kit of claim 1 wherein said first and/or second container are syringes containing said prostaglandin.

4. The kit of claim 1 wherein said first container contains about 40 to about 130 nanograms of said prostaglandin.

5. The kit of claim 4 wherein said first container contains about 65 nanograms of said prostaglandin in a 1 cc solution.

6. The kit of claim 1 which additionally includes a third container comprising about 25 to about 200 nanograms of said prostaglandin for injection into said artery after an angioplasty procedure.

7. The kit of claim 6 wherein said third container contains about 40 to about 130 nanograms of said prostaglandin.

8. The kit of claim 7 wherein said third container contains about 65 nanograms of said prostaglandin in a 1 cc solution.

9. The kit of claim 1 wherein said second container is a container of saline solution containing an amount of said prostaglandin to provide a 15 to about 40 nanograms of prostaglandin per kilogram of body weight per minute.

10. The kit of claim 1 wherein said prostaglandin in each of said containers is present in a carrier comprising:

(a) an isotonic solution;

(b) an angiographic contrast material;

(c) a biodegradable prostaglandin carrying microsphere;

or

(d) a combination thereof.

11. The kit of claim 10 wherein said microspheres comprise:

(a) albumen laden microspheres;

(b) carbohydrate laden microspheres;

or

(c) free fatty acid laden microspheres.

12. The kit of claim 10 wherein said carrier comprises:

(a) an isotonic solution which is present in a 5 cc amount;

(b) an angiographic contrast material present in an amount of about 3 cc to about 10 cc per bolus;

or

(c) biodegradable prostaglandin carrying microspheres having sizes within the range of about 10 microns to about 100 microns and which are present in an amount of about 225,000 to about 500,000.

13. The kit of claim 6 wherein said prostaglandin is present in a carrier comprising:

(a) an isotonic solution;

(b) an angiographic contrast material;

(c) a biodegradable prostaglandin carrying microsphere;

or

(d) a combination thereof.

14. The kit of claim 13 wherein said microspheres comprise:

(a) albumen laden microspheres;

(b) carbohydrate laden microspheres;

or

(c) free fatty acid laden microspheres.

15. The kit of claim 13 wherein said carrier comprises:

(a) an isotonic solution which is present in a 5 cc amount;

(b) an angiographic contrast material present in an amount of about 3 cc to about 10 cc per bolus;

or

(c) biodegradable prostaglandin carrying microspheres having sizes within the range of about 10 microns to about 100 microns and which are present in an amount of about 225,000 to about 500,000.