Vascular embolization with an expansible implant

• US 7,201,762 B2
• Filed: 12/16/2002
• Issued: 04/10/2007
• Est. Priority Date: 07/06/1998
• Status: Expired due to Term

• Current Assignee: Microvention Incorporated (Terumo Corporation)
• Original Assignee: Microvention Incorporated (Terumo Corporation)
• Inventors: Greene, George R. Jr., Rosenbluth, Robert F., Cox, Brian J.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US10/320,033
• Publication Number:
  US 20030088311A1
• Time in Patent Office: 1,576 Days
• Field of Search: 623/11.11, 623/1.4, 623/1.39, 623/1.21, 623/1.11, 606/191
• US Class Current: 606/191
• 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 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices artificial blood vessels A61L27/507
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: B33Y 50/00 Data acquisition or data processing for additive manufacturing
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device
• CPC Class Codes: Y10S 623/903 Blood vessel
• CPC Class Codes: Y10T 29/49 Method of mechanical manufacture

Abstract

A vascular implant formed of a compressible foam material has a compressed configuration from which it is expansible into a configuration substantially conforming to the shape and size of a vascular site to be embolized. Preferably, the implant is formed of a hydrophilic, macroporous foam material, having an initial configuration of a scaled-down model of the vascular site, from which it is compressible into the compressed configuration. The implant is made by scanning the vascular site to create a digitized scan data set; using the scan data set to create a three-dimensional digitized virtual model of the vascular site; using the virtual model to create a scaled-down physical mold of the vascular site; and using the mold to create a vascular implant in the form of a scaled-down model of the vascular site. To embolize a vascular site, the implant is compressed and passed through a microcatheter, the distal end of which has been passed into a vascular site. Upon entering the vascular site, the implant expands in situ substantially to fill the vascular site. A retention element is contained within the microcatheter and has a distal end detachably connected to the implant. A flexible, tubular deployment element is used to pass the implant and the retention element through the microcatheter, and then to separate the implant from the retention element when the implant has been passed out of the microcatheter and into the vascular site.

Claims

1. A method of embolizing a vascular sit comprising the steps of:

(a) providing a vascular implant comprising a hydrophilic hydrogel and having an initial compressed configuration, wherein the implant is releasably attached, in its initial configuration, to the distal end of a flexible, elongate deployment element that includes a coiled element;

(b) providing a microcatheter having a distal end, and passing the microcatheter intravascularly until its distal end is situated closely adjacent to or within the vascular site;

(c) passing the implant and the deployment element through the microcatheter until the implant emerges from the distal end of the microcatheter;

(d) controllably releasing the implant from the deployment element; and

(e) expanding the implant in situ in the vascular site from its initial configuration to an expanded configuration that substantially fills the vascular site, primarily by hydrophilic hydration.

2. A method of embolizing a vascular site, comprising the steps of:

(a) providing a vascular implant attached to the distal end of an elongate filamentous retention element, the implant comprising a macroporous hydrophilic hydrogel foam implant and having an initial compressed configuration, from which it is expansible into an expanded configuration substantially conforming to the vascular site;

(b) passing the implant and the retention element through a coiled deployment element having a distal end until the implant emerges from the distal end of the deployment element;

(c) passing a microcatheter intravascularly until its distal end is situated within the vascular site;

(d) passing the deployment element through the microcatheter, while the implant is in its initial configuration, until the implant emerges from the distal end of the microcatheter into the vascular site;

(e) controllably detaching the implant from the retention element; and

(f) expanding the implant in situ primarily by hydrophilic hydration substantially to fill the vascular site.

3. The method of claim 2, wherein the detaching step is performed by pulling the retention element proximally with respect to the deployment element, so that the implant is pushed off the end of the retention element by means of the pressure applied to it by the distal end of the deployment element.

4. Apparatus for embolizing a vascular site, comprising:

a deployment element having a distal end and comprising a flexible elongate coil; and

an expansile embolizing element, comprising a hydrophilic hydrogel and having an initial compressed configuration, wherein the embolizing element is releasably attached to the distal end of the deployment element, and wherein the embolizing element expands in stiu, after being controllably released from the deployment element in the vascular site, from its initial configuration to an expanded configuration primarily by hydrophilic hydration.

5. The apparatus of claim 4, wherein the hydrogel is a hydrophilic polymer selected from the group consisting of olefins, polyvinyl alcohol, and PHEMA.

6. The apparatus of claim 4, wherein the embolizing element is formed of a molded hydrogel.

7. The apparatus of claim 4, wherein the hydrogel is porous.

8. The apparatus of claim 4, wherein the hydrogel includes a radiopaque material.

9. The apparatus of claim 4, wherein the hydrogel includes a drug that is releasable into the vascular site.

10. Apparatus for embolizing a vascular site, comprising:

a deployment element having a distal end and comprising a flexible, elongate coil;

an expansile embolizing element, comprising a hydrophilic hydrogel and having an initial compressed configuration, wherein the embolizing element is releasable attached to the distal end of the deployment element, and wherein the embolizing element expands in situ, after being controllably released from the deployment element in the vascular site, from its initial configuration to an expanded configuration primarily by hydrophilic hydration, wherein the hydrogel has a water content of a least about 90% when fully hydrated.

11. The apparatus of claim 10, wherein the hydrogel is a hydrophilic polymer selected from the group consisting of olefins, polyvinyl alcohol and PHEMA.

12. The apparatus of claim 10, wherein the embolizing element is formed of a molded hydrogel.

13. The apparatus of claim 10, wherein the hydrogel is porous.

14. The apparatus of claim 10, wherein the hydrogel includes a radiopaque material.

15. The apparatus of claim 10, wherein the hydrogel includes a drug that is releasable into the vascular site.