VASCULAR FILTER SYSTEM AND METHOD OF DEPLOYMENT AND RETRIEVAL OF A VASCULAR FILTER
A vascular filter system for deploying a vascular filter utilizes a plurality of tensors that extend radially outward from a deployment sheath. The ends of the tensors are coupled with an attachment ring of the vascular filter and a plurality of attachment barbs are coupled with the attachment ring for securing the filter to the vessel wall. A method for retrieving the vascular filter from the vessel utilizes a reverse curve catheter, a guidewire that extends therethrough and an intravascular snare. The guidewire is advanced around the filter and into the snare which secures the guidewire around the filter for retrieval. A vessel distention device utilizes one or more distention tensors having a distention feature on the extended end, such as a blunt tip, to press on the inside vessel wall. The distention tensors extend out radially from a sheath to press on the vessel wall.
The present application is a continuation of U.S. patent application Ser. No. 16/708,407, filed on Dec. 9, 2019, now U.S. Pat. No. 11,564,786, which is a continuation-in-part of U.S. patent application Ser. No. 15/747,641, filed on Jan. 25, 2018, now U.S. Pat. No. 10,500,034, which is a National Stage Application of International Patent Application No. PCT/US2017/041625, filed on Jul. 12, 2017, which claims the benefit of priority to U.S. Provisional Patent Application No. 62/491,867, filed on Apr. 28, 2017.
BACKGROUND OF THE INVENTION Field of the InventionThe invention relates to a vascular filter system and method to deploy and retrieve the vascular filter.
BackgroundVascular filters are used to prevent emboli and other debris from flowing to critical areas of the body, such as the brain or lungs. Vascular filters are often deployed but are seldom retrieved. In many cases, the vascular filter is retained in the vessel was with barbs. These bars can extend through the vessel wall leading to leakage from the vessel and/or damage to surrounding tissue. Most vascular filters comprise wire frames and/or wire filter elements. These wires can fracture due to flex fatigue and flow downstream along the vessel and lodge in undesirable locations. In addition, the vascular filter can slide along the vessel and may block branch vessels in doing so, or flow to undesirable locations. Finally, vascular filters can occlude over time which may lead to thrombus formation. There is some description of vascular filters that comprise bioresorbable materials in the prior art, however these devices comprise wire frame components that require removal.
SUMMARY OF THE INVENTIONThe invention is directed to a vascular filter system for deploying a vascular filter and a system and method for retrieving the vascular filter from a lumen, such as a vessel. An exemplary vascular filter comprises an attachment ring, a plurality of attachment barbs coupled to the attachment ring, and a plurality of filter strand threads forming a vascular filter web portion having filter openings. The vascular filter portion is coupled to the attachment ring and a plurality of attachment barbs extend from the attachment ring for attaching and retaining the vascular filter to a lumen. In an exemplary embodiment, the filter strands comprise, consist essentially of or consist of a bioresorbable material. In an exemplary embodiment, the filter strand threads are very flexible and non-free-standing, as defined herein. The filter web may be flexible and easily deformable, like a net. The filter web may have filter opening that are no more than about 10 mm, or no more than about 8 mm, or no more than about 6 mm, or between 3 mm and 6 mm and any range between and including the filter opening dimensions provided. The filter opening dimension is the largest straight-line dimension across a filter opening. In an exemplary embodiment, the attachment ring and the filter web are made of bioresorbable material and the attachment barbs are made of a metallic material.
An exemplary filter web comprises ring strands and fill strands. Exemplary fill strands extend from the attachment ring, up over the distal end of the filter web and back to the attachment ring on an opposing side of the attachment ring. Exemplary ring strands extend substantially perpendicularly to the fill strands in a circle and offset an offset distance from the attachment ring. Adjacent ring strands and adjacent fill strands form filter openings. The entire filter web may be made from material that is bioresorbable. The size or composition of the filter strand threads may change from one location to another to allow a portion of the filter web to dissolve before another portion of the filter web. For example, a filter web may be designed such that the distal end, or end furthest from the attachment frame, dissolves prior to a portion of the filter web more proximal to the attachment ring. In this way, the size of particles, or portion of the filter web that may break free from the retained filter web or attachment ring may be minimized. The ring strands may be configured to dissolve prior to the fill strands, or ring strands furthest from the attachment ring may dissolve more quickly than ring strands more proximal to the attachment ring. Likewise, the fill strands may have a change in diameter or thickness wherein the fill strands are thickest or slowest to dissolve proximal to the attachment ring.
An exemplary filter portion comprises a spirographic loop that may be made up of a single continuous filter strand. This type of filter web may enable an intravascular snare to couple with and withdraw the filter web from a single location, as the filter web is made of a continuous loop. A spirographic loop type filter web may be configured with filter end loops and the attachment barbs may be connected to these filter end loops.
Fluoroscopy may be used to view the location of the vascular filter in a vessel lumen and a radiopaque material may be incorporated into the vascular filter for this purpose. The attachment barbs and/or the attachment ring may be made out of a radiopaque material or may comprise a radiopaque coating. Likewise, the filter strand threads may be made out of a radiopaque material or comprise a radiopaque coating. A radiopaque material may be gold, or platinum or other metallic material.
An exemplary vascular filter may be deployed using a vascular filter system comprising a deployment sheath that retains a plurality of tensors. The tensors may be made out of shape memory material, such as Nitinol, or out of a material have some elasticity, such as spring-metal or polymer. The tensors are retained within the deployment sheath and when the distal end of the tensor extends from the distal-end opening of the deployment sheath, they bend out radially. A tensor coupler is configured on the distal end of the tensor and the tensor coupler is coupled with the attachment ring. The vascular filter is deployed and attached to the inside wall of the vessel when the tensors extend out radially and press the attachment barbs into the vessel wall. The attachment barbs are attached to the attachment ring.
A distension device comprises a plurality of tensors that extend radially outward from an opening in a sheath and may have a distension end that is blunt for pressing on the inside vessel wall to distend it outward.
A vascular filter may be retrieved using an exemplary vascular filter retrieval system comprising a sheath, a reverse curve catheter, a guidewire and an intravascular snare. In an exemplary vascular filter retrieval method, a sheath is advanced into a vessel lumen until the distal end and sheath opening is proximal to the vascular filter that is attached to the vessel. The guidewire is then advanced through the sheath and beyond a portion of the vascular filter. The reverse curve catheter is then advanced over the guidewire and advance beyond a portion of the vascular filter, wherein the curve portion of the reverse curve catheter is beyond a portion of the vascular filter, and in some cases on the opposing side of the vascular filter from the distal end of the sheath. The guidewire is advanced through the curve portion of the reverse curve catheter and back toward the distal end of the sheath. An intravascular snare is advanced out of the sheath opening. The distal end of the guidewire is advanced through snare opening and the snare is closed to retain the guidewire therein. A loop is made around the vascular filter or a portion of the vascular filter by the reverse curve catheter and the guidewire. The guidewire and reverse curve catheter are then pulled back into the sheath to retrieve the vascular filter. A portion or all of the vascular filter may be pulled into the sheath. The distal ends of the guidewire, the reverse curve catheter and the vascular filter may be pulled into the sheath and the sheath may be withdrawn from the vessel.
In an exemplary embodiment, a tensor may be a distention tensor and have a distention feature at the extended end of the distention tensor for pressing against the inside surface of a vessel wall to distend the vessel. An exemplary distention feature may be a blunt end of the tensor or a disc shaped feature for pressing against the inside vessel wall. A distention feature may have a dimension that is at least three or five or more times greater than the diameter or cross-length dimension of the distension tensor. A distention feature may be disc, having a diameter or blunt dimension that is five or more times greater than the diameter of the distention tensor. In an exemplary embodiment, a distention device comprises two or more, or three or more distention tensors that extend out from the sheath radially in a substantially uniformly spaced circumferential orientation to distend the vessel, thereby increasing interior area or inner diameter of the vessel. A larger number of distention tensors may provide for more complete and uniform distention of the vessel, wherein a tensor extends out radially with a circumferential spacing from an adjacent distention of no more than about 130 degrees, or no more than about 120 degrees, or no more than about 90 degrees, or no more than about 60 degrees, or no more than about 45 degrees. A distention device having four distention tensors circumferentially spaced at about 90 degrees may effectively distend a vessel. A substantially uniformly spaced circumferential orientation of the distention tensors means that each tensor is space circumferentially from an adjacent tensor within about 20% of a uniform circumferential spacing, or 360 degrees divided by the number of tensors. For example, a distention device with four tensors would have a uniform spacing of 90 degrees between tensors, and a substantially uniform spacing within about 20% of 90 degrees for each adjacent tensor.
An exemplary tensor may be configured with a stylet extending through a conduit of the tensor and connected to a release feature coupled to the tensor coupler 90. An exemplary tensor coupler may be detachably attached to barb tether, which may be the attachment ring. Manipulation of the stylet, such as pulling on the stylet may release the tensor coupler from the attachment ring. A release feature on the tensor coupler may comprise a hinge, including a living hinge, to allow the coupler to detach from the barb tether. In an exemplary embodiment, the tensor coupler comprises a coupler slot that is configured around the barb tether and pulling of the stylet opens the coupler slot to disengage the tensor coupler from the barb tether. In another embodiment, the tensor coupler is retained by the barb release feature configured on the barb or on the barb tether, and manipulation of the stylet releases the tensor coupler from the barb release feature. For example, the barb release feature may extend at least partially around the tensor coupler and pulling of the stylet may release the tensor coupler from the barb release feature. In an exemplary embodiment, a vascular filter, or portion thereof is coated with a therapeutic agent including, but not limited to, heparin and paclitaxel. A therapeutic agent may prevent thrombosis.
The summary of the invention is provided as a general introduction to some of the embodiments of the invention and is not intended to be limiting. Additional example embodiments including variations and alternative configurations of the invention are provided herein.
The accompanying drawings are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and together with the description serve to explain the principles of the invention.
Corresponding reference characters indicate corresponding parts throughout the several views of the figures. The figures represent an illustration of some of the embodiments of the present invention and are not to be construed as limiting the scope of the invention in any manner. Further, the figures are not necessarily to scale, some features may be exaggerated to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present invention.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTSAs used herein, the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having” or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Also, use of “a” or “an” are employed to describe elements and components described herein. This is done merely for convenience and to give a general sense of the scope of the invention. This description should be read to include one or at least one and the singular also includes the plural unless it is obvious that it is meant otherwise.
Certain exemplary embodiments of the present invention are described herein and are illustrated in the accompanying figures. The embodiments described are only for purposes of illustrating the present invention and should not be interpreted as limiting the scope of the invention. Other embodiments of the invention, and certain modifications, combinations and improvements of the described embodiments, will occur to those skilled in the art and all such alternate embodiments, combinations, modifications, improvements are within the scope of the present invention.
Definitions:The filter strand threads that form the vascular filter web of the present invention are non-freestanding and flexible with little to no elastic memory. A strand thread will easily deform under a load.
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It will be apparent to those skilled in the art that various modifications, combinations and variations can be made in the present invention without departing from the spirit or scope of the invention. Specific embodiments, features and elements described herein may be modified, and/or combined in any suitable manner. Thus, it is intended that the present invention cover the modifications, combinations and variations of this invention provided they come within the scope of the appended claims and their equivalents.
Claims
1. A vascular filter system comprising:
- a) a vascular filter comprising: i) a barb tether having a barb release feature; ii) a plurality of attachment barbs coupled to the barb tether; iii) a filter web comprising a filter strand forming filter openings, wherein the filter web portion is coupled to the barb tether;
- b) a deployment sheath having a distal end opening;
- c) a plurality of tensors, each of said plurality of tensors comprising: i) an extended end; ii) a tensor coupler attached to said extended end; wherein the plurality of tensors are retained within the deployment sheath; wherein the tensor couplers are coupled with the barb release feature; wherein each of the tensor couplers are detachably attached to the barb release feature; and wherein the plurality of tensors are shape memory material and wherein each are configured to extend radially outward from the distal end opening of the deployment sheath to press the barb tether, and attachment barbs coupled thereto, against a vessel wall.
2. The vascular filter system of claim 1, wherein the barb tether forms an attachment ring.
3. The vascular filter system of claim 1, further comprising a stylet extending along the tensor to the tensor coupler and configured to release the tensor coupler from the barb tether.
4. The vascular filter system of claim 3, wherein the tensor coupler extends at least partially around the barb release feature and wherein the stylet is configured to open the tensor coupler when tension is applied to release the tensor coupler from the barb release feature.
5. The vascular filter system of claim 4, wherein the barb release feature comprises a shape of the barb tether configured to fit within the tensor coupler.
6. The vascular filter system of claim 5, wherein the barb tether is a portion of an attachment ring.
7. The vascular filter system of claim 5, wherein the barb tether extends from the attachment ring.
8. The vascular filter system of claim 3, wherein the barb release feature extends at least partially around the tensor coupler and wherein the stylet is configured to pull the tensor coupler from the barb release feature when tension is applied to release the tensor coupler from the barb release feature.
9. The vascular filter system of claim 1, wherein the filter web comprises a bioresorbable filter strand.
10. The vascular filter system of claim 1 wherein the filter web consists essentially of a bioresorbable filter strand.
11. The vascular filter system of claim 1, wherein the filter openings have a dimension of no more than 10 mm.
12. The vascular filter system of claim 1, wherein the plurality of attachment barbs are metallic.
13. The vascular filter system of claim 1, wherein the filter web consists essentially of a bioresorbable filter strand, and wherein the plurality of attachment barbs are metallic.
14. The vascular filter system of claim 1, wherein each of the plurality of attachment barbs comprises an insert end and a barb portion.
15. The vascular filter system of claim 1, comprising a radiopaque material on the attachment ring.
16. The vascular filter system of claim 1, comprising a radiopaque material on the attachment barb.
17. The vascular filter system of claim 1, comprising a radiopaque material on the filter web.
18. The vascular filter system of claim 1, wherein a web comprises a first portion of a plurality of filter strands having a higher dissolving rate than a second portion of a plurality of filter strands.
19. The vascular filter system of claim 1, wherein the filter web consists of a spirographic loop.
20. The vascular filter system of claim 19, wherein the spirographic loop consists of a single continuous strand.
Type: Application
Filed: Jan 30, 2023
Publication Date: Jun 8, 2023
Inventor: Kevin T. Lie (Greenville, DE)
Application Number: 18/102,953