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EP-3868415-B1 - EXPANDABLE IMPLANT AND IMPLANT SYSTEM

EP3868415B1EP 3868415 B1EP3868415 B1EP 3868415B1EP-3868415-B1

Inventors

  • WILSON, THOMAS
  • SMALL IV, WARD
  • BENETT, WILLIAM J.
  • ORTEGA, JASON M.
  • MAITLAND, DUNCAN J.
  • HARTMAN, JONATHAN

Dates

Publication Date
20260506
Application Date
20111215

Claims (12)

  1. : An implantable system to fill an anatomical void, the system comprising: a carrier element (810, 834, 864, 230, 231, 240, 306, 205, 410, 503, 605, 705) provided to assume primary and secondary shapes; and a monolithic shape memory polymer foam (836, 850, 245, 226, 227, 310, 311, 402, 403) covering a majority of the carrier element (810, 834, 864, 230, 231, 240, 306, 205, 410, 503, 605, 705), , having primary and secondary shapes and including first (802, 831, 861) and second (803, 832, 862) monolithic shape memory polymer foam portions spaced apart from each other along the carrier element by a joint (821, 822, 823; 852, 853), the carrier element extending axially through the first and second monolithic shape memory polymer foam portions; wherein the primary shape of the carrier element (810, 834, 864, 230, 231, 240, 306, 205, 410, 503, 605, 705) and of the first and second monolithic shape memory polymer foam portions (836, 850, 245, 226, 227, 310, 311, 402, 403) are such that the carrier element (810, 834, 864, 230, 231, 240, 306, 205, 410, 503, 605, 705) and the first and second monolithic shape memory polymer foam portions (831, 861) can pivot about the joint (821, 822, 823; 852, 853) such that the first and second monolithic shape memory polymer foam portions are partially flush against one another and a slit is partially opened between the first and second monolithic shape memory polymer foam portions at the joint; and wherein the secondary shape of the carrier element (810, 834, 864, 230, 231, 240, 306, 205, 410, 503, 605, 705) and of the first and second monolithic shape memory polymer foam portions (836, 850, 245, 226, 227, 310, 311, 402, 403) are such that the carrier element (810, 834, 864, 230, 231, 240, 306, 205, 410, 503, 605, 705) and the first and second monolithic shape memory polymer foam portions (836, 850, 245, 226, 227, 310, 311, 402, 403) can flexibly pivot about the joint (821, 822, 823; 852, 853) with the first and second monolithic shape memory polymer foam portions being generally flush with one another; wherein an adhesive couples the monolithic shape memory polymer foam (836, 850, 245, 226, 227, 310, 311, 402, 403) to the carrier element (810, 834, 864, 230, 231, 240, 306, 205, 410, 503, 605, 705); the adhesive adhering to the carrier element (810, 834, 864, 230, 231, 240, 306, 205, 410, 503, 605, 705) and the monolithic shape memory polymer foam (836, 850, 245, 226, 227, 310, 311, 402, 403) adhering to the adhesive.
  2. . The implantable system of claim 1, wherein the carrier element (810, 834, 864, 230, 231, 240, 306, 205, 410, 503, 605, 705) includes a shape memory alloy that has said primary and secondary shapes.
  3. . The implantable system of claim 2, wherein the shape memory alloy includes Nitinol.
  4. . The system of claim 1, wherein the monolithic shape memory polymer foam (836, 850, 245, 226, 227, 310, 311, 402, 403) in the secondary shape has a second modulus and in the primary shape has a first modulus, the second modulus being greater than the first modulus.
  5. . The system according to any of claims 1-4, wherein the monolithic shape memory polymer foam (836, 850, 245, 226, 227, 310, 311, 402, 403) is greater than 5 cm in length.
  6. . The system according to any of claims 1-5, wherein the adhesive includes urethane.
  7. . The system according to any of claims 1-6, wherein the carrier element (810, 834, 864, 230, 231, 240, 306, 205, 410, 503, 605, 705) includes a shape memory polymer.
  8. . The system according to any of claims 1-6, wherein the carrier element (810, 834, 864, 230, 231, 240, 306, 205, 410, 503, 605, 705) includes a polymer strand.
  9. . The system according to any of claims 1-8, wherein the monolithic shape memory polymer foam (836, 850, 245, 226, 227, 310, 311, 402, 403) is radiopaque.
  10. . The system according to any of claims 1-9, wherein the monolithic shape memory polymer foam (836, 850, 245, 226, 227, 310, 311, 402, 403) has a glass transition temperature less than 37.7 degrees Celsius.
  11. . The system according to any of claims 1-10, further comprising a pusher wire (805, 835; 1305) detachably coupled to the carrier element.
  12. . The system according to any of claims 1-11, wherein said slit does not extend from the exterior surface of monolithic shape memory polymer foam (836, 850, 245, 226, 227, 310, 311, 402, 403) all the way to the carrier element.

Description

FIELD Various embodiments of the invention concern the treatment of anatomical malformations. Some embodiments concern expandable embolic agents. BACKGROUND Cerebral aneurysms may develop when a weakened area of a blood vessel (e.g., a blood vessel in or around the brain) bulges outward. If not treated, aneurysms can rupture resulting in hemorrhagic stroke, a major cause of mortality and long-term disability. Taking cerebral aneurysms for example, there are several modalities used to treat cerebral aneurysms including: (1) traditional surgical clipping, and (2) endovascular embolization. Surgical clipping is a traumatic procedure that involves craniotomy, retraction of the brain to expose the aneurysm, and placement of a metal clip across the aneurysm neck. Endovascular embolization is a minimally invasive technique in which embolic agents are delivered into the aneurysm via a catheter, under fluoroscopic (x-ray) guidance, to occlude the aneurysm and promote healing. Regarding endovascular embolization, the Gugliemi Detachable Coil (GDC) allows a surgeon to deploy a helical platinum coil into the aneurysm. Once in proper position, the coil is detached from the delivery apparatus and released into the aneurysm. Multiple coils may be required to effectively fill the aneurysm and induce clotting and eventual sealing of the aneurysm from the parent vessel. Such coils are subject to problematic issues with recanalization and related insufficient healing. Though not as prevalent as embolic coils, liquid embolic agents that solidify inside the aneurysm are also available for clinical use in rare cases. However, such agents can be difficult to precisely administer at specific sites. US 2007/135907 discloses a stent for treating a physical anomaly. The stent includes a skeletal support structure for expanding in the physical anomaly and a shape memory material coupled to the skeletal support structure. US 2005/267570 discloses an implantable stent-like device for treating and occluding arteriovascular malformations (AVMs), fistulas, varicose veins or the like. More particularly, this reference relates to an implant body that includes an open-cell shape-transformable polymer structure that provides stress-free means for occluding an AVM without applying additional pressures an any distended walls of the AVM. In one embodiment, the shape-transformable polymer is a shape memory polymer implant body that self-deploys from a temporary shape to a memory shape. In another embodiment, the shape memory polymer structure is capable of a temporary compacted shape for carrying about the struts of an expandable stent for self-deployment to occlude an aneurysm. US 2005/228417 discloses devices for removing a matter from a body cavity of a patient. One of such devices has an elongated carrier having a distal portion adapted to move through or within the cavity and a proximate portion. A radially expandable polymer is circumferentially attached to the distal portion of the carrier and adapted to enter the matter while in a compressed configuration and capable of transitioning to an expanded configuration while inside the matter to penetrate and engage it from within. Methods of removing a matter from a body cavity and methods of localized delivery of a therapeutic agents also are disclosed. BRIEF DESCRIPTION OF THE DRAWINGS Features and advantages of embodiments of the present invention which is illustrated in figures 8A-9B, will become apparent from the appended claims, the following detailed description of one or more example embodiments, and the corresponding figures, in which: Figure 1 includes an embodiment not part of the present invention for embolization of an aneurysm with an expandable apparatus delivered endovascularly.Figure 2 include embodiments not part of the present invention of shape memory polymer (SMP) elements, backbones, and monolithic SMPs covering long portions of backbones.Figure 3 includes embodiments not part of the present invention, in compressed pre-delivery stage and uncompressed, expanded post-delivery stage.Figure 4 includes an embodiment not part of the present invention, with spacers located between expandable elements.Figure 5 includes a heated carrier embodiment not part of the present invention.Figure 6 includes an embodiment not part of the present invention, with a fiber optic light diffuser delivery mechanism.Figure 7 includes an embodiment not part of the present invention, with a fiber optic light diffuser delivery mechanism.Figure 8 includes a flexible embodiment of a monolithic SMP device.Figure 9 includes a flexible embodiment of a SMP device.Figure 10 includes a flexible embodiment not part of the present invention, of a tapered monolithic SMP device.Figure 11 includes a process for embolization of an aneurysm in an embodiment.Figure 12 includes an embodiment not part of the present invention, comprising a microcatheter, collar, and sheath.Figure 13 includes stages of delivery for embol