Patent Application
20250134642
N/A
Not applicable
Not applicable
The present invention relates to bioresorbable vascular implants such as filters (e.g., vena cava filters), occlusion devices, stents and convertible stents. More particularly, the present invention relates to an improved vascular implant that bioresorbs into a patient's vascular system (e.g., inferior vena cava, iliofemoral vein, ovarian veins, splenic artery, uterine artery, hepaticartery or other vein/artery vessel). For example, the present invention bioresorbs into a patient's vascular system (e.g. inferior vena cava or iliofemoral vein) after transient risk of pulmonary embolism (PE) has subsided. The entire implant structure could be made of bioresorbable material, such as a bioresorbable polymer so that no implant or implant remnant/element would ultimately be left behind as the entire implant would resorb into vascular tissue. In one or more preferred embodiments, the implant preferably has a body with a tubular outer wall with an interior bore, a multi-panel outer wall, and filtering elements connecting the panels together.
In one or more embodiments, the filter preferably has a hub head that can be annular, ring shaped or rounded, wherein the filtering element connects to the head, annular member or ring shaped hub.
Vascular implants include various devices that are placed at a selected locale in a patient's blood vessel. One example is a vena cava filter. Other examples include occlusion devices, stents and convertible stents. Various patents have issued for vascular implants. Patents have also issued that relate in general to 3D printing of implants. Examples are listed in the following Table 1. Each patent listed in Table 1 is hereby incorporated herein by reference.
The present invention provides a vascular implant preferably having a tubular body of a polymeric material, having opposed filter body ends and a central longitudinal axis.
In one or more preferred embodiments, the body has a generally tubular segmented side wall that preferably includes multiple spaced apart wall panels surrounding a central open ended bore. The segmented tubular wall allows the device to be compressed to fit inside a delivery system and reduces the amount of material that needs to be resorbed.
In one or more embodiments, the body preferably includes one or more filtering elements in said bore and in between filter body ends.
In one or more embodiments, one or more filtering elements preferably include a hub at the central longitudinal axis and multiple radially extending filtering arms that extend between the hub and the wall, wherein each arm connects to the hub and a wall panel.
In one or more embodiments, the tubular body can have anchors that prevent migration and/or tilting.
In one or more embodiments, the body is of a resorbable material.
In one or more embodiments, the body is of a material that is too soft to be machined.
In one or more embodiments, the opposed ends of the body preferably include an upper end and a lower end.
In one or more embodiments, one or more of the arms extend outwardly from the hub toward one of said ends.
In one or more embodiments, one or more of said arms extend from the hub upwardly toward the body upper end.
In one or more embodiments, the body is of a polymeric material that has a durometer reading that is between 10 Shore A and 75 Shore D.
In one or more embodiments, the body is of a polymeric material that has a durometer reading that is between 35 Shore A and 75 Shore D.
In one or more embodiments, the body is of a polymeric material that has a durometer reading that is between 10 Shore A and 40 Shore A.
In one or more embodiments, the body and one or more filtering elements define a vena cava filter.
In one or more embodiments, the body and one or more filtering elements define an occlusion device.
In one or more embodiments, the body and one or more filtering elements define a convertible stent.
In one or more embodiments, the tubular body is of a polymeric material, has opposed filter body ends and a central longitudinal axis.
In one or more embodiments, the body preferably has a segmented side wall that includes multiple circumferentially spaced apart wall panels and a central bore. The body preferably includes one or more filtering elements in said bore and in between filter body ends.
In one or more embodiments, one or more filtering elements include a hub at a central longitudinal axis and multiple radially extending filtering arms that extend radially between the hub and the wall, wherein each arm connects to the hub and a wall panel.
In one or more embodiments, the tubular body preferably has anchors that prevent migration and/or tilting.
In one or more embodiments, the body and one or more filtering elements define a stent.
In one or more embodiments, each filtering arm preferably forms an acute angle with the central longitudinal axis.
In one or more embodiments, each filtering member/connecting member/strut/arm/appendage is connected to head/ring/annular member/hub via holes/sockets/bores and features a ball and socket connection.
In one or more embodiments, the holes through which each filtering member pass can be conically or frusto-conically shaped.
In one or more embodiments, each filtering member/connecting member/strut/arm/appendage has a ball and socket connection to both the central head/ring/annular member/hub and each outer wall section/panel.
In one or more embodiments, each outer wall section has a hole or socket or bore for a filter member to pass through.
In one or more embodiments, each hole or socket or bore on the outer wall can be open ended and can be conically or frusto-conically shaped in the same manner as the annular ring.
For a further understanding of the nature, objects, and advantages of the present invention, reference should be had to the following detailed description, read in conjunction with the following drawings, wherein like reference numerals denote like elements and wherein:
Body 11 has a segmented side or outer wall 15 comprised of a plurality of circumferentially spaced apart wall sections or panels 16-23. The wall sections or panels 16-23 are distributed around the central longitudinal axis. The wall sections or panels 16-23 extend in this embodiment parallel to the central longitudinal axis. When placed in a vessel, the outwards facing surface of the wall sections or panels 16-23 abut to the vessel and extend in a direction more or less parallel to the direction of blood-flow through the vessel. Due to the wall sections or panels 16-23, the implant can reduce the risk of damage to the vessel. In case the wall sections or panels 16-23 are of a (bio-)resorbable material, they will be resorbed into the vascular tissue after a certain period of time. Panels or wall sections 16-23 can be generally rectangular in shape. Panels or wall sections 16-23 could be other shapes such as square, oval, rectangular, or provided with chamfer or fillets on corners of each of the square or rectangular shapes.
Each panel or wall section 16-23 can have a convex outer surface 32 and a concave inner surface 33, as seen in
The panels 16-23 define a central bore in which one or more filtering elements extend. More specifically, these filtering elements extend in radial direction from the center of the tubular body 11 up to a respective wall section or panel 16-23 and lay in axial direction between the filter body ends 34,35. Each wall section or panel 16-23 is connected to head, hub, ring or annular member 12 with a filtering member, connecting member, strut, arm or appendage 24, 25, 26, 27, 28, 29, 30 or 31 as seen in
As is apparent from
In
One or more of the panels or wall sections 16-23 is preferably provided with one or more anchors. In
Once implemented at a selected locale in a patient's vascular system (e.g., using a catheter), the anchors 36, 37 prevent migration and/or tilting of the filter body 11 in either direction (either toward end 34 or toward end 35). When of a bioresorbable material, the bioresorption starts as soon as the implant is exposed to the blood and like many of the standard polymers degrades over time via polymer breakdown and absorption of the byproducts. This bioresorption can be tuned as needed to ensure the implant maintains structural filtering integrity until transient risk of pulmonary embolism has subsided. As noted, the segmented tubular wall reduces the amount of material that needs to be resorbed.
The implant 10 could be deployed with either a femoral or jugular approach. Such a deployment could employ a pusher or pusher apparatus/mechanism such as one specified in one or more of the patents listed in Table 1. An example is U.S. Pat. No. 8,518,072 naming Jonathan Miller as inventor and assigned to C.R. Bard, Inc. Implant 10 could also be a balloon-mounted implant that is then expanded with balloon dilation, as seen, for example, in balloon expandable stents.
Filter body can be manufactured with 3D printing, such as a one piece polymeric body 11. For inferior vena cava pulmonary embolism prevention, the diameter of implant 10 can be between about 15-30 mm. For iliofemoral pulmonary embolism protection, the diameter of implant 10 can be between about 6-20 mm. For other smaller vessels for occlusion, implant 10 can have a diameter of between about 2-8 mm. The length of implant 10 can be between about 5-50 mm.
In another embodiment, shown in
Radial movement can be effected by balloon deployment, wedge, or inherent spring force (for example, if the filaments were attached but of sufficient elasticity to deform without breaking). Preferably, wall panels 216-223 when deployed move axially rather than radially when going from a transported to expanded configuration. Although struts 124-131 of
The vascular implant can thus be characterized by comprising:
Without limitation, the implant may further be characterized by one or more of the following statements.
Statement 1: A vascular implant, comprising:
Statement 2: The vascular implant of statement 1 wherein the body is of a resorbable material.
Statement 3: The vascular implant of one or more of the preceding statements wherein the body is of a material that is too soft to be machined.
Statement 4: The vascular implant of one or more of the preceding statements wherein said opposed ends include an upper end and a lower end.
5: The vascular implant of one or more of the preceding statements wherein one or more of said arms extend from said hub toward one of said ends.
Statement 6: The vascular implant of statement 4 wherein one or more of said arms extend from said hub upwardly toward said upper end.
Statement 7: The vascular implant of one or more of the preceding statements wherein said polymeric material has a hardness that is a durometer reading of between about 35 Shore A and 75 Shore D.
Statement 8: The vascular implant of one or more of the preceding statements wherein said polymeric material is too soft to be machined.
Statement 9: The vascular implant of one or more of the preceding statements wherein the body and one or more filtering elements define a vena cava filter.
Statement 10: The vascular implant of one or more of the preceding statements wherein the body and one or more filtering elements define an occlusion device.
Statement 11: The vascular implant of one or more of the preceding statements wherein the body and one or more filtering elements define a convertible stent.
Statement 12: A vascular implant, comprising:
Statement 13: The vascular implant of statements 12 wherein the body is of a resorbable material.
Statement 14: The vascular implant of one or more of statements 12-13, wherein the body is of a material that is too soft to be machined.
Statement 15: The vascular implant of one or more of statements 12-14, wherein said polymeric material is too soft to be machined.
Statement 16: The vascular implant of one or more of statements 12-15, wherein the body and one or more filtering elements define a vena cava filter.
Statement 17: The vascular implant of one or more of statements 12-16, wherein the body and one or more filtering elements define an occlusion device.
Statement 18: The vascular implant of one or more of statements 12-17, wherein the body and one or more filtering elements define a convertible stent.
Statement 19: The vascular implant of one or more of statements 12-18, wherein each filtering arm forms an acute angle with said central longitudinal axis.
Statement 20: A vascular implant, comprising:
The following is a list of parts and materials suitable for use in the present invention.
All measurements disclosed herein are at standard temperature and pressure, at sea level on Earth, unless indicated otherwise. All materials used or intended to be used in a human being are biocompatible, unless indicated otherwise.
The foregoing embodiments are presented by way of example only; the scope of the present invention is to be limited only by the following claims.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2021/073176 | 12/30/2021 | WO |
