This disclosure relates to a system, apparatus, and method for collecting emboli and, more particularly, to an embolic dual-filtration device and method for use.
During procedures such as, but not limited to, thrombectomy, atherectomy, balloon angioplasty, stent deployment, and/or cardiac lead extraction, debris such as plaque, blood clots, vegetation, and debris associated with cardiac lead extraction can move from the treatment site through a vein or artery and compromise the flow of blood at a location downstream from the treatment site by creating an embolism. Various embolism protection systems may be used to help prevent such debris from traveling and/or embolizing within a vessel such as filters and occlusive devices.
Currently, embolic protection systems are commonly used for coronary, carotid, and peripheral procedures. The application of currently existing embolic protection systems to protect a pulmonary artery may be undesirable due to unsuitable designs and the incompatibility of the filters of the existing embolic protection systems to accomplish the desired filtration function in the pulmonary artery.
In an aspect, an embolic dual-filtration device is provided. The embolic dual-filtration device has a first filter and a second filter. Each of the first and second filters has pores. The second filter is positioned adjacent to the first filter. The first and second filters are capable of being selectively rotated with respect to one another. The first and second filter pores of the rotated first and second filters collectively form a moiré lattice structure. The moiré lattice structure has pores smaller than the pores of each of the separate first and second filters.
In an aspect, a system for collecting emboli in the pulmonary artery is provided. The system has a first filter. The first filter has a first filter support structure and a first filter mesh. The first filter support structure is capable of engaging patient pulmonary artery tissue. The first filter mesh has pores and is attached to at least a portion of the first filter support structure. The system has a second filter. The second filter has a second filter support structure and a second filter mesh. The second filter support structure is capable of engaging patient pulmonary artery tissue. The second filter mesh has pores and is attached to at least a portion of the second filter support structure. The second filter is positioned longitudinally adjacent to the first filter. The first and second filters are coaxially arranged relative to one another. The first and second filters are capable of being rotated with respect to one another once positioned in the patient pulmonary artery. The system includes a catheter configured to access the patient pulmonary artery. The catheter has a catheter lumen. The catheter lumen is configured to allow the first and second filters to pass therethrough. The first and second filter meshes of the rotated first and second filters collectively form a moiré lattice structure. The moiré lattice structure has pores smaller than the pores of each of the separate first and second filters.
In an aspect, a method for collecting emboli is provided. An embolic dual-filtration device is provided. The embolic dual-filtration device has a first filter and a second filter. Each of the first and second filters has pores. The second filter is positioned adjacent to the first filter. The first and second filters are capable of being selectively rotated with respect to one another. The embolic dual-filtration device is inserted into a patient pulmonary artery. The embolic dual-filtration device is maintained in the patient pulmonary artery. With the embolic dual-filtration device maintained in the patient pulmonary artery, the first and second filters are independently, selectively rotated to collectively form a moiré lattice structure. The moiré lattice structure has varying sized pores relative to the independent rotation of the first and second filters. The force of blood flow within the patient pulmonary artery is utilized to restrict blood-carried emboli that are larger than the pores of the moiré lattice structure to a location on an upstream side of the moiré lattice structure. The first filter, the second filter, and the restricted emboli are removed from the patient pulmonary artery. The emboli restricted to the upstream side of the moiré lattice structure are removed from the patient pulmonary artery when the first and second filters are removed from the patient pulmonary artery.
For a better understanding, reference may be made to the accompanying drawings, in which:
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of skill in the art to which the present disclosure pertains.
As used herein, the term “patient” can refer to any warm-blooded organism including, but not limited to, human beings, pigs, rats, mice, dogs, goats, sheep, horses, monkeys, apes, rabbits, cattle, farm animals, livestock, birds, etc.
As used herein, the term “user” can be used interchangeably to refer to an individual who prepares for, assists, and/or performs a procedure.
As used herein, the singular forms “a,” “an” and “the” can include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” as used herein, can specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof.
As used herein, the term “and/or” can include any and all combinations of one or more of the associated listed items.
As used herein, phrases such as “between X and Y” can be interpreted to include X and Y.
It will be understood that when an element is referred to as being “on,” “attached” to, etc., another element, it can be directly on or attached to the other element or intervening elements may also be present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may not have portions that overlap or underlie the adjacent feature. Further, it will be understood that when an element is referred to as being “adjacent” to another element, it can be contacting or spaced apart from the other element.
It will be understood that, although the terms “first,” “second,” etc. may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. Thus, a “first” element discussed below could also be termed a “second” element without departing from the teachings of the present disclosure. The sequence of operations (or steps) is not limited to the order presented in the claims or Figures unless specifically indicated otherwise.
The invention comprises, consists of, or consists essentially of the following features, in any combination.
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The second filter mesh 320 has pores 322. The second support structure 318 formed at least partially from the second filter mesh 320 may have pores 322. The size of the pores 322 in the second filter mesh 320 may be larger than 250 microns. The size of the pores 322 in the second filter mesh 320 may be the same size as the pores 216 in the first filter mesh 214 or may be smaller than the pores 216 in the first filter mesh 214. The second filter 106 may be positioned longitudinally adjacent to the first filter 104. The term “longitudinal” is used herein to indicate a substantially vertical direction, in the orientation of
The first and second filters 104, 106 may be coaxially arranged relative to one another. The term “coaxially arranged” is used herein to indicate a positioning in which two or more elements have the same radical axis and/or centroid, such as the positioning of the first and second filters 104, 106 as shown in
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The first and second filters 104, 106 may each be formed at least partially from a deformable material. The deformable material may be elastic and/or a shape memory alloy, such as, but not limited to, nitinol. As shown in
The embolic dual-filtration device 100 may, for example, be collapsed into the collapsed condition by cooling the first and second filters 104, 106 to a temperature below a transition temperature range of the shape memory alloy. The first and second filters 104, 106 may be formed into the expanded condition as a first predetermined shape above a transition temperature range, the transition temperature range being dependent on the particular ratio of metals in the alloy. Below the transition temperature range, the alloy is highly ductile and may be plastically deformed into a second desired shape, such as the collapsed condition. Upon reheating above the transition temperature range, the alloy returns to its first predetermined shape, such as the expanded condition.
The embolic dual-filtration device 100 may also or instead be collapsed into the collapsed condition by the user and/or catheter lumen providing a laterally and/or longitudinally inward force on each of the first and second filters 104, 106. The dimensions of the catheter lumen 108, which are laterally smaller than the expanded embolic dual-filtration device 100, prevent the embolic dual-filtration device 100 from moving to the expanded condition when the embolic dual-filtration device 100 is passed through the catheter lumen 108. The embolic dual-filtration device 100 returns to its expanded condition when the laterally and/or longitudinally inward force provided by the user and/or the catheter lumen is removed. Further, the embolic dual-filtration device 100 may be collapsed/expanded to its collapsed/expanded condition in any desired manner, with or without an interaction by the user, such as by a mechanism that is triggered to automatically collapse/expand the embolic dual-filtration device 100, and/or by the user manually collapsing/expanding the embolic dual-filtration device 100 directly, indirectly, or both.
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The second filter deployment tool 1140 and attached second filter 106 may be configured to pass through at least one of the first filter deployment tool inner lumen 936 and the catheter lumen 108 when the second filter 106 is in the collapsed position. As shown in
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In use, the embolic dual-filtration device 100, as described above, is provided to the user. The embolic dual-filtration device 100 is collapsed into the collapsed condition. The embolic dual-filtration device 100 may be collapsed into the collapsed condition by cooling of the first and second filters 104, 106 to a temperature below a transition temperature range of a shape memory alloy. The embolic dual-filtration device 100 may also or instead be collapsed into the collapsed condition by provision of a laterally and/or longitudinally inward force on each of the first and second filters 104, 106. The embolic dual-filtration device 100 may also or instead be collapsed into the collapsed condition in any desired manner, with or without an interaction by the user, such as by a mechanism that is triggered to automatically collapse the embolic dual-filtration device 100, and/or by the user manually collapsing the embolic dual-filtration device 100 directly, indirectly, or both. As shown in
With the embolic dual-filtration device 100 in the collapsed condition, the embolic dual-filtration device 100 is passed through the catheter lumen 108 and inserted into the patient pulmonary artery P. The embolic dual-filtration device 100 may be passed along the previously inserted guidewire. The embolic dual-filtration device 100 may be restricted from expanding while being passed through the catheter lumen 108 by the dimensions of the catheter lumen 108 being too small to allow the embolic dual-filtration device 100 to be moved into the expanded condition.
With the embolic dual-filtration device 100 in the patient pulmonary artery P, the embolic dual-filtration device 100 is expanded into the expanded condition in the patient pulmonary artery P. The embolic dual-filtration device 100 may be expanded by exposure of the embolic dual-filtration device 100 to blood having a temperature greater than the transition temperature range of the shape memory alloy. The embolic dual-filtration device 100 may be expanded by allowing the embolic dual-filtration device 100 to self-expand once unrestricted by the catheter lumen 108. The embolic dual-filtration device 100 may also be expanded in any desired manner, with or without an interaction by the user that causes the embolic dual-filtration device 100 to expand once properly positioned in the patient pulmonary artery P, such as by a mechanism that is triggered to automatically expand the embolic dual-filtration device 100, and/or by the user manually expanding the embolic dual-filtration device 100 directly, indirectly, or both.
The embolic dual-filtration device 100 is maintained in the patient pulmonary artery P. The embolic dual-filtration device 100 may be maintained in the patient pulmonary artery P by selective attachment of the first and second tissue engagement members 1250, 1252 to at least one of patient pulmonary artery tissue T, patient right ventricle tissue RV, and patient right atrium tissue RA. When the first and second tissue engagement members 1250, 1252 are attached to at least one of patient pulmonary artery tissue T, patient right ventricle tissue RV, and patient right atrium tissue RA, the first and second anchoring members 1246, 1248 hold the embolic dual-filtration device 100 in the patient pulmonary artery P to prevent the embolic dual-filtration device 100 from egressing from a desired position.
With the embolic dual-filtration device 100 being maintained in the patient pulmonary artery P, the first and second filters 104, 106 are independently and selectively rotated, in a similar manner to that previously described, to collectively form a moiré lattice structure 524 having varying sized pores 526 relative to the independent rotation of the first and second filters 104, 106.
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As described above, the embolic dual-filtration device 100 may be provided with the first and second filter deployment tools 934, 1140. In use, the first filter 104 is collapsed into the collapsed condition on the first filter deployment outer wall 938 in a similar sequence to that previously described. With the first filter 104 in the collapsed condition, the first filter deployment tool 934 is inserted into the patient pulmonary artery P. As shown in
The embolic dual-filtration device 100 is maintained in the patient pulmonary artery P. With the embolic dual-filtration device 100 being maintained in the patient pulmonary artery P, the first and second filters 104, 106 are independently, selectively rotated, in a similar manner to that previously described, to form a moiré lattice structure 524 having varying sized pores 526 relative to the independent rotation of the first and second filters 104, 106. The force of blood flow is utilized within the patient pulmonary artery P to restrict blood-carried emboli that are larger than the pores 526 of the moiré lattice structure 524 to an upstream side of the moiré lattice structure 524. The embolic dual-filtration device 100 is collapsed into the collapsed condition in a similar sequence to that previously described. When the embolic dual-filtration device 100 is collapsed into the collapsed condition, the emboli are maintained within the embolic dual-filtration device 100 as a result of the collapsed embolic dual-filtration device 100 at least partially surrounding the emboli. The first filter 104, the second filter 106, and the restricted emboli are removed from the patient pulmonary artery P in a similar sequence to that previously described.
It is contemplated that the embolic dual-filtration device 100 may include a stretching tool (not shown) that is inserted into the patient pulmonary artery P to longitudinally stretch the collapsed embolic dual-filtration device 100 with restricted emboli to re-shape the volume of the embolic dual-filtration device 100 to a shape capable of passing through the catheter lumen 108.
It is contemplated that the first filter deployment tool 934 may have a first filter deployment tool side port (not shown). The first filter deployment tool side port may extend between the first filter deployment tool outer wall 938 and the first filter deployment tool inner lumen 936 to put the first filter deployment tool inner lumen 936 in fluid communication with the first filter deployment tool outer wall 938. The second filter deployment tool 1140 and attached second filter 106 may be configured to at least partially pass through the first filter deployment tool side port and into the first filter deployment tool inner lumen 936. In such case, with the second filter 106 in the collapsed condition, the second filter deployment tool 1140 may at least partially be inserted through the first filter deployment tool side port, through the first filter deployment tool inner lumen 936, and into the patient pulmonary artery P.
It is contemplated that the collapsed embolic dual-filtration device 100 may be configured to reduce the amount of captured emboli being extruded through the pores of the collapsed embolic dual-filtration device 100 or mitigate a “cheese grater” scraping effect. Instead of or in addition to reducing the amount of captured emboli being extruded, it is contemplated that the collapsed embolic dual-filtration device 100 may be configured to prevent captured emboli from extruding through the pores of the collapsed embolic dual-filtration device 100 or mitigate a “cheese grater” scraping effect. For example, a radial inward force may be applied by the collapsed embolic dual-filtration device 100 to hold the captured emboli on the moiré lattice structure 524, but without enough force to extrude the captured emboli through the pores 526.
It is contemplated that the size and/or a shape of at least one of the pores 216, 322 of the first and second filter meshes 214, 320, respectively, may be selectively adjusted in any desired manner, with or without an interaction by the user, such as by a mechanism that is triggered to automatically adjust the size and/or the shape of at least one of the pores 216, 322 of the first and second filter meshes 214, 320, respectively, and/or by the user manually adjusting the size and/or the shape of at least one of the pores 216, 322 of the first and second filter meshes 214, 320, respectively, directly, indirectly, or both.
The catheter 102, the first filter 104, the second filter 106, the first drive shaft 828, the second drive shaft 830, the first filter deployment tool 934, the second filter deployment tool 1140, the first anchoring member 1246, and/or the second anchoring member 1248 may each be at least partially formed from silicone, polyethylene, polypropylene, stainless steel, titanium, nitinol, any other shape memory alloy, any other biocompatible material, or any combination thereof.
The embolic dual-filtration device 100 assists the user in collecting emboli traveling through the patient pulmonary artery P. The embolic dual-filtration device 100 may assist the user in preventing embolization during a procedure such as, but not limited, to, a lead extraction, a percutaneous clot removal from the inferior vena cava, a percutaneous clot removal from the superior vena cava, or any suitable procedure.
Although the embolic dual-filtration device 100, to that previously described, as being used in a patient pulmonary artery P, it should be understood that the embolic dual-filtration device 100 may be used in any similar lumen to collect emboli or other undesirable matter traveling through that lumen.
While aspects of this disclosure have been particularly shown and described with reference to the example aspects above, it will be understood by those of ordinary skill in the art that various additional aspects may be contemplated. For example, the specific methods described above for using the apparatus are merely illustrative; one of ordinary skill in the art could readily determine any number of tools, sequences of steps, or other means/options for placing the above-described apparatus, or components thereof, into positions substantively similar to those shown and described herein. In an effort to maintain clarity in the Figures, certain ones of duplicative components shown have not been specifically numbered, but one of ordinary skill in the art will realize, based upon the components that were numbered, the element numbers which should be associated with the unnumbered components; no differentiation between similar components is intended or implied solely by the presence or absence of an element number in the Figures. Any of the described structures and components could be integrally formed as a single unitary or monolithic piece or made up of separate sub-components, with either of these formations involving any suitable stock or bespoke components and/or any suitable material or combinations of materials; however, the chosen material(s) should be biocompatible for many applications. Any of the described structures and components could be disposable or reusable as desired for a particular use environment. Any component could be provided with a user-perceptible marking to indicate a material, configuration, at least one dimension, or the like pertaining to that component, the user-perceptible marking potentially aiding a user in selecting one component from an array of similar components for a particular use environment. A “predetermined” status may be determined at any time before the structures being manipulated actually reach that status, the “predetermination” being made as late as immediately before the structure achieves the predetermined status. The term “substantially” is used herein to indicate a quality that is largely, but not necessarily wholly, that which is specified—a “substantial” quality admits of the potential for some relatively minor inclusion of a non-quality item. Though certain components described herein are shown as having specific geometric shapes, all structures of this disclosure may have any suitable shapes, sizes, configurations, relative relationships, cross-sectional areas, or any other physical characteristics as desirable for a particular application. Any structures or features described with reference to one aspect or configuration could be provided, singly or in combination with other structures or features, to any other aspect or configuration, as it would be impractical to describe each of the aspects and configurations discussed herein as having all of the options discussed with respect to all of the other aspects and configurations. A device or method incorporating any of these features should be understood to fall under the scope of this disclosure as determined based upon the claims below and any equivalents thereof.
Other aspects, objects, and advantages can be obtained from a study of the drawings, the disclosure, and the appended claims.
This application claims priority from U.S. Provisional Application No. 62/455,672, filed 7 Feb. 2017, the subject matter of which is incorporated herein by reference in its entirety.
Number | Date | Country | |
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62455672 | Feb 2017 | US |