Method and device for treating venous insufficiency and varicose veins

Abstract

One larger [1] and one smaller tube [2], forming a functional unit with the smaller tube [2] positioned within the larger tube [1], both tubes are relocatable and demountable, both tubes with an aperture [3 and 4] at both ends, at least one aperture [5] being provided in the wall of the outer tube located at a distance of about between 1 mm and 10 cm from the tip [6], or several apertures positioned in a segment of 1-250 mm from the tip, wherein the diameter of the single aperture is between 70% and 120% of the inner diameter of the outer tube [1], or in case of several apertures, for each aperture 30-60% of the inner diameter of the outer tube, wherein the outer diameter of the inner tube is between 0.6 mm and 2.0 mm (F2 to F6), the outer diameter of the outer tube is between 1.3 mm and 3.6 mm (F4 to F11), and the distance between the outer wall of the inner tube and the inner wall of the outer tube is between 0.1 mm to 3.0 mm.

Claims

1. A kit comprising: a pharmaceutically acceptable tissue glue that can polymerize on contact with H.sub.2O, blood, or constituent parts of blood, a medical gas, for use in treating varicose veins, and a sclerosant drug, wherein said medical gas is configured to be combined with said tissue glue to prepare a foam or gel glue for injection within a vein, the kit further comprising a catheter having an outer tube and an inner tube, the outer tube being fluidly isolated from the inner tube and having at least one side hole provided therein, wherein the outer tube of the catheter is designed to evacuate blood from a target vein, and to administer and withdraw the sclerosant drug through one or more holes of the at least one side hole, and the inner tube of the catheter is designed to administer a composition comprising the pharmaceutically acceptable tissue glue and the medical gas, wherein the inner tube of the catheter is configured to administer said tissue glue and said medical gas in a 1:1 to 1:4 ratio, and wherein the inner tube of the catheter is configured to administer said tissue glue in an amount of 0.1 mL to 0.5 mL per injection.

2. The kit according to claim 1, wherein the outer tube contains the sclerosant drug, and wherein the inner tube contains the foam or gel glue.

3. The kit according to claim 2, wherein the outer tube has opposing ends and a wall extending between the opposing ends, and wherein at least one aperture is defined within the wall of the outer tube.

4. A method of treating a subject using a kit having a composition and a double tube injection and aspiration catheter, the method comprising: intravenously applying, at one or more sites of treatment, the composition by the double tube injection and aspiration catheter, the catheter having an outer tube and an inner tube, the outer tube having at least one side hole provided therein, the composition comprising: a) a pharmaceutically acceptable tissue glue that can polymerize on contact with H.sub.2O, blood or constituent parts of blood, b) a medical gas, for use in treating varicose veins, and c) a sclerosant drug; and performing the following steps at each of the one or more sites of treatment: aspirating blood of the subject through one or more holes of the at least one side hole provided in the outer tube to collapse a vein; administering the sclerosant drug as a first foam through one or more holes of the at least one side hole provided in the outer tube; aspirating the sclerosant drug through one or more holes of the at least one side hole provided in the outer tube; and applying the tissue glue and medical gas via the inner tube as a second foam or gel while maintaining negative pressure via the outer tube, wherein said medical gas is combined with said tissue glue to prepare the second foam or gel for injection within the vein, wherein said tissue glue and said medical gas are applied in a 1:1 to 1:4 ratio, and wherein said tissue glue is provided in an amount of 0.1 mL to 0.5 mL per injection.

5. The method according to claim 4, wherein the tissue glue is selected from the list of cyanoacrylate and fibrin glue.

6. The method according to claim 4, wherein the medical gas is selected from the list of carbon dioxide, oxygen, air, or mixtures thereof.

7. The method according to claim 4, wherein said tissue glue and said medical gas are loaded in the inner tube of the double tube injection and aspiration catheter.

8. The method according to claim 4, wherein said tissue glue and said medical gas are loaded in the inner tube of the double tube injection and aspiration catheter.

9. A method of treating a subject using a kit having a composition and a double tube injection and aspiration catheter, the method comprising: intravenously applying, at one or more sites of treatment, the composition by the double tube injection and aspiration catheter, the catheter having an outer tube and an inner tube, the outer tube having at least one side hole provided therein, the composition comprising: a) a pharmaceutically acceptable tissue glue that can polymerize on contact with H.sub.2O, blood or constituent parts of blood, b) a medical gas, for use in treating varicose veins, and c) a sclerosant drug; and performing the following steps at each of the one or more sites of treatment: aspirating blood of the subject through one or more holes of the at least one side hole of the outer tube to collapse a vein; administering the sclerosant drug as a first foam through one or more holes of the at least one side hole of the outer tube; aspirating the sclerosant drug through one or more holes of the at least one side hole of the outer tube; and sequentially applying the medical gas and the tissue glue via the inner tube while maintaining negative pressure via the outer tube, wherein at least a first portion of the medical gas is applied in a first bolus and the tissue glue is subsequently applied in a second bolus, and wherein said tissue glue and said medical gas are applied in a 1:1 to 1:4 ratio, and wherein said tissue glue is provided in an amount of 0.1 mL to 0.5 mL per injection.

10. The method according to claim 9, wherein a second portion of the medical gas is applied in a third bolus following application of the second bolus.

11. The method according to claim 9, wherein the tissue glue is selected from the list of cyanoacrylate and fibrin glue.

12. The method according to claim 9, wherein the medical gas is selected from the list of carbon dioxide, oxygen, air, or mixtures thereof.

Description

FIGURE CAPTIONS

(1) FIG. 1: a) The basic parts of the system: Outer tube [1], inner tube [2], position when mounted. b) endovenous approach to target vein segment

(2) FIG. 2:

(3) Inner tube [2], examples of embodiments: a) straight tip, b) straight tip with side holes, c) flat-angled tip with side hole, d) sharp angled tip.

(4) FIG. 3:

(5) Outer catheter with side holes [5] in the tip section[6].

(6) FIG. 4:

(7) Catheter with calculated side hole dimensions and position provides uniform and distinct foam sclerosant propagation along target vein with outstanding precision, based on uniform pressure distribution.

(8) FIG. 5: a) The space taken by the catheter should equal the space taken by the foam sclerosant.

(9) D=diameter of vein in the patient in horizontal position, d=diameter of the catheter.

(10) The condition for optimal sclerofoam treatment is fulfilled when
(d/2).sup.2×π=(D/2).sup.2×π−(d/2).sup.2×π b) Schematic illustration: a) cross section; b) longitudinal cut showing uniform and precise foam distribution around catheter.

(11) FIG. 6:

(12) Additional tube [8], covering or uncovering the side holes of the outer tube, a) cross-sectional view; b) side holes of outer catheter covered by additional tube [8], c) single side hole uncovered, d) multiple side holes uncovered. e) The additional tube [8] may have a grip zone[10], or handle [11], for easier sliding action, and markings to indicate the additional catheter's position[9].

(13) FIG. 7:

(14) Catheter options: a) elevations of inner tube at distal tip to stabilize position within outer catheter; b) narrowing of outer catheter to fix inner catheter, both options either covering the whole circumference (e) or parts of it (e).

(15) FIG. 8:

(16) Typical application at a junction segment, a) positioning of outer tube relative to position of treatment border [12], b) position of inner tube, c) evacuation of blood and target segment collapse, d) application of sclerofoam, e) vein spasm, evacuation of foam, f) system loaded with glue or glue-gas compositions, g) application of glue, h) withdrawal of system to next position, treated vein segment permanently closed.

(17) FIG. 9:

(18) Typical application at a non-junction segment, a) positioning of outer tube, and b) inner tube, c) evacuation of blood until vein segment collapses, d) application of sclerofoam, e) vein spasm, evacuation of foam, f) application of glue, g) system withdrawal to next position, treated vein segment permanently closed.