EMBOLIZATION PARTICLES AND METHOD FOR MAKING SAME

• US 20100042067A1
• Filed: 08/18/2008
• Published: 02/18/2010
• Est. Priority Date: 08/18/2008
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Koehler, Cleve
• Granted Patent: US 8,246,876 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/418 Agents promoting blood coagulation, blood-clotting agents, embolising agents
• CPC Class Codes: A61L 24/001 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00

Abstract

In at least one embodiment of the present invention, a method for making embolization particles for occluding fluid flow through a body vessel is provided. The method comprises positioning an elongated body of biocompatible material relative to a cutting device. The elongated body is defined by extrusion of a body cross-section along a longitudinal axis. The elongated body is cut with a cutting device at a plurality of locations along the longitudinal axis to form the embolization particles such that each of the embolization particles has a particle cross-section that corresponds to the body cross-section.

Claims

1. A method for making embolization particles for occluding fluid flow through a body vessel, the method comprising:

moving an elongated body of biocompatible material and a cutting device relatively towards each other, the elongated body defined by extrusion of a body cross-section along a longitudinal axis; and

cutting the elongated body with the cutting device at a plurality of locations along the longitudinal axis to form the embolization particles such that each of the embolization particles has a particle cross-section that substantially matches the body cross-section.

2. The method according to claim 1 wherein the body cross-section is substantially circular.

3. The method according to claim 2 wherein the body cross-section has a diameter in the range of about 100 to 400 μ

m.

4. The method according to claim 1 wherein the plurality of locations along the longitudinal axis are spaced apart in the range of about 300 to 500 μ

m.

5. The method according to claim 1 wherein the step of cutting includes cutting the elongated body transverse to the longitudinal axis at the plurality of locations.

6. The method according to claim 1 wherein the biocompatible material includes a biodegradable polymer.

7. The method according to claim 1 wherein the cutting device includes one of a shearing element and a laser for cutting the elongated body.

8. The method according to claim 1 further comprising tensioning the elongated body between at least two tensioning members.

9. The method according to claim 8 further comprising coating the elongated body with a medicant during the step of tensioning the elongated body.

10. The method according to claim 1 further comprising coating the elongated body with a medicant by one of spray coating and dip coating the medicant onto the elongated body.

11. The method according to claim 1 wherein the biocompatible material contains an additive comprising at least one of a medicant and a radiopacifier.

12. An embolization kit for occluding fluid flow through a body vessel, the kit comprising:

a plurality of embolization particles formed of biocompatible material, each of the embolization particles having two opposing surfaces and a longitudinal axis extending between the two opposing surfaces and being defined by extrusion of a cross-section between the opposing surfaces along the longitudinal axis; and

a microcatheter configured to be positioned within the body vessel and to deploy the embolization particles.

13. The kit according to claim 12 wherein the opposing surfaces are substantially planar surfaces which are substantially parallel to each other.

14. The kit according to claim 12 wherein the embolization particles are coated with a medicant.

15. The kit according to claim 12 wherein the microcatheter catheter has a lumen for advancing the embolization particles for deployment, the lumen having a diameter corresponding to the cross-sections of the embolization particles.

16. The kit according to claim 15 wherein the embolization particles are contained within the microcatheter in an “

as packaged”

conditioned, the longitudinal axes of the embolization particles being aligned with each other and with a central longitudinal axis of the lumen.

17. The kit according to claim 12 further comprising a guide catheter and the microcatheter is further configured to be passed through the guide catheter to position the microcatheter catheter in the body vessel.

18. The kit according to claim 12 further comprising a guide wire and wherein the microcatheter is configured to be passed along the guide wire to be positioned in the body vessel.

19. A method for occluding fluid flow through a body vessel, the method comprising:

positioning a distal end of a microcatheter within the body vessel; and

deploying a plurality of embolization particles formed of biocompatible material from the distal end of the microcatheter into the body vessel, each of the embolization particles having two opposing surfaces and a longitudinal axis extending between the two opposing surfaces and being defined by extrusion of a cross-section between the opposing surfaces along the longitudinal axis.

20. The method according to claim 19 wherein the microcatheter has a lumen in fluid communication with the distal end, the lumen has a diameter corresponding to the cross-sections of the embolization particles, and the step of deploying the embolization particles includes advancing the embolization particles through the lumen to the distal end of the microcatheter such that the longitudinal axes of the embolization particles are aligned with each other and with a central longitudinal axis of the lumen.