Patent Application
20210145561
The present invention relates generally to a device for cerebral embolic protection, and more particularly to a device for cerebral embolic protection during a heart valve replacement procedure.
Transcatheter aortic valve replacement (TAVR) has become increasingly popular for replacing native heart valves in recent years. However, their delivery and implantation carries with it the risk of embolic material being carried away by the bloodstream and to the brain, which can cause a stroke. As a result, cerebral embolic protection (CEP) devices are provided to reduce the risk of stroke. However, CEP devices are delivered to the site where they are deployed through a different entry pathway than the TAVR. This requires two separate devices, and increases the risk of complications.
Percutaneous balloon aortic valvuloplasty (PBAV) is another known cardiac procedure that carries the risk of calcium breaking off and embolizing (traveling) to the brain. In PBAV a catheter is used to deliver a balloon to the native valve site to dilate the stenosed aortic valve. PBAV can be performed as a standalone procedure or prior to TAVR.
The background description disclosed anywhere in this patent application includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
In accordance with a first aspect of the present invention there is provided a catheter assembly that includes a catheter, a heart valve procedure device positioned at a distal end of the catheter, and an embolic protection device positioned on the catheter proximal of the heart valve procedure device. The embolic protection device is movable between a stowed position and a deployed position. In a preferred embodiment, the catheter assembly includes a switch member that is configured to move the embolic capture device between the stowed position and the deployed position. Preferably, the switch member is movable between a first position and a second position, and movement of the switch from the first position to the second position moves the embolic capture device from the stowed position to the deployed position.
In a preferred embodiment, the embolic protection device is an embolic capture device that is positioned to span the ascending aorta when in the deployed position. The embolic capture device is configured to capture embolic material. Preferably, the embolic capture device includes a filter portion and a plurality of stretcher members. The stretcher members are movable from a collapsed position to an expanded position to move the filter portion from the stowed position to the deployed position. In a preferred embodiment, the stretcher members are movable within one or more slots defined a wall of the catheter. The One end of the slot represents or stops the stretcher member in the collapsed position, and the opposite end of the slot represents or stops the stretcher member in the expanded position.
In a preferred embodiment, the embolic protection device is an embolic deflection device that is positioned to occlude the aortic arch vessels when in the deployed position. The embolic deflection device is configured to deflect embolic material from the aortic arch vessels while allowing blood to perfuse therethrough (through the filter portion).
In a preferred embodiment, the catheter defines a first lumen and a second lumen therein. The first lumen is associated with the heart valve procedure device and the second lumen is associated with the embolic protection device. At least a portion of the components for deploying the heart valve procedure device extend through the first lumen and at least a portion of the components for deploying the embolic protection device extend through the second lumen. The heart valve procedure device can include a replacement heart valve and/or an expandable balloon, among other devices. The embolic protection device can be self-expanding.
In a preferred embodiment, the catheter assembly includes a switch member and at least a first runner member operatively disposed between the switch member and the stretcher members. Movement or actuation of the switch member from a first position to a second position (first and second position can apply to an electrical switch) moves the runner member within the catheter and moves the embolic capture device from the stowed position to the deployed position.
In a preferred embodiment, the embolic capture device includes a filter portion having a catheter opening defined therein. The catheter extends through the catheter opening. The filter portion is co-axial with the catheter.
In accordance with another aspect of the present invention there is provided a method performed in a heart that includes a heart valve that includes the steps of (a) obtaining a catheter assembly that includes a heart valve procedure device positioned at a distal end of a catheter, and an embolic protection device positioned on the catheter proximal of the heart valve procedure device, (b) maneuvering the catheter assembly to a position such that the heart valve procedure device is positioned adjacent the heart valve and the embolic protection device is positioned proximal the heart valve procedure device, (c) moving the embolic protection device from a stowed position to a deployed position, and (d) deploying the heart valve procedure device. In a preferred embodiment, the catheter defines a first lumen and a second lumen therein and the performance of step (d) is associated with the first lumen and the performance of step (c) is associated with the second lumen. It will be appreciated that in a TAVR procedure, the embolic protection device is positioned and configured to prevent embolic material from entering the aortic arch vessels.
The present invention is the combination of a cerebral embolic protection (CEP) device in combination with a heart valve procedure device (replacement heart valve, balloon, balloon expandable valve, self-expanding replacement heart valve) that is delivered via a catheter.
In a preferred embodiment, the present invention provides a CEP device together with a transcatheter aortic valve replacement valve (a TAVR) as a single unit. The CEP device can be a polyurethane 130 to 150u filter embedded in or “preloaded” on a TAVR device. In a preferred embodiment, the CEP/TAVR system comes as a single unit and the CEP can be deployed and retrieved during the TAVR procedure.
In another embodiment the heart valve procedure device is a percutaneous balloon aortic valvuloplasty (PBAV) balloon that is provided together with a CEP device or system. The embolization protection “filter” device can be attached to or part of the the balloon catheter used in PBAV and can be positioned several centimeters above the balloon in the ascending aorta. This allows for capturing of calcium and other debris which might come off the valve and prevent it from going to the brain. Accordingly, the filter or CEP device can be delivered as a unit with a balloon used for PBAV or a TAVR device.
CEP devices for use during the performance of cardiac procedures and delivered by catheter are known. For example, see US Publication No. 2001/0020160 and US Publication No. 2016/0151141, the entireties of which are incorporated by reference herein.
The invention may be more readily understood by referring to the accompanying drawings in which:
Like numerals refer to like parts throughout the several views of the drawings.
The following description and drawings are illustrative and are not to be construed as limiting. Numerous specific details are described to provide a thorough understanding of the disclosure. However, in certain instances, well-known or conventional details are not described in order to avoid obscuring the description. References to one or an embodiment in the present disclosure can be, but not necessarily are references to the same embodiment; and, such references mean at least one of the embodiments. If a component is not shown in a drawing then this provides support for a negative limitation in the claims stating that that component is “not” present. However, the above statement is not limiting and in another embodiment, the missing component can be included in a claimed embodiment.
Reference in this specification to “one embodiment,” “an embodiment,” “a preferred embodiment” or any other phrase mentioning the word “embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the-disclosure and also means that any particular feature, structure, or characteristic described in connection with one embodiment can be included in any embodiment or can be omitted or excluded from any embodiment. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Moreover, various features are described which may be exhibited by some embodiments and not by others and may be omitted from any embodiment. Furthermore, any particular feature, structure, or characteristic described herein may be optional. Similarly, various requirements are described which may be requirements for some embodiments but not other embodiments. Where appropriate any of the features discussed herein in relation to one aspect or embodiment of the invention may be applied to another aspect or embodiment of the invention. Similarly, where appropriate any of the features discussed herein in relation to one aspect or embodiment of the invention may be optional with respect to and/or omitted from that aspect or embodiment of the invention or any other aspect or embodiment of the invention discussed or disclosed herein.
The terms used in this specification generally have their ordinary meanings in the art, within the context of the disclosure, and in the specific context where each term is used. Certain terms that are used to describe the disclosure are discussed below, or elsewhere in the specification, to provide additional guidance to the practitioner regarding the description of the disclosure. For convenience, certain terms may be highlighted, for example using italics and/or quotation marks: The use of highlighting has no influence on the scope and meaning of a term; the scope and meaning of a term is the same, in the same context, whether or not it is highlighted.
It will be appreciated that the same thing can be said in more than one way. Consequently, alternative language and synonyms may be used for any one or more of the terms discussed herein. No special significance is to be placed upon whether or not a term is elaborated or discussed herein. Synonyms for certain terms are provided. A recital of one or more synonyms does not exclude the use of other synonyms. The use of examples anywhere in this specification including examples of any terms discussed herein is illustrative only, and is not intended to further limit the scope and meaning of the disclosure or of any exemplified term. Likewise, the disclosure is not limited to various embodiments given in this specification.
Without intent to further limit the scope of the disclosure, examples of instruments, apparatus, methods and their related results according to the embodiments of the present disclosure are given below. Note that titles or subtitles may be used in the examples for convenience of a reader, which in no way should limit the scope of the disclosure. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. In the case of conflict, the present document, including definitions, will control.
It will be appreciated that terms such as “front,” “back,” “top,” “bottom,” “side,” “short,” “long,” “up,” “down,” “aft,” “forward,” “inboard,” “outboard” and “below” used herein are merely for ease of description and refer to the orientation of the components as shown in the figures. It should be understood that any orientation of the components described herein is within the scope of the present invention.
Generally, the present invention is the combination of a cerebral embolic protection device (CEP device or embolic protection device) in combination with another heart valve procedure device that are delivered together via a catheter. As shown in
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Unless the context clearly requires otherwise, throughout the description and the claims, the words “comprise,” “comprising,” and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to.” As used herein, the terms “connected,” “coupled,” or any variant thereof, means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof. Additionally, the words “herein,” “above,” “below,” and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of this application. Where the context permits, words in the above Detailed Description of the Preferred Embodiments using the singular or plural number may also include the plural or singular number respectively. The word “or” in reference to a list of two or more items, covers all of the following interpretations of the word: any of the items in the list, all of the items in the list, and any combination of the items in the list.
The above-detailed description of embodiments of the disclosure is not intended to be exhaustive or to limit the teachings to the precise form disclosed above. While specific embodiments of and examples for the disclosure are described above for illustrative purposes, various equivalent modifications are possible within the scope of the disclosure, as those skilled in the relevant art will recognize. Further, any specific numbers noted herein are only examples: alternative implementations may employ differing values, measurements or ranges.
Although the operations of any method(s) disclosed or described herein either explicitly or implicitly are shown and described in a particular order, the order of the operations of each method may be altered so that certain operations may be performed in an inverse order or so that certain operations may be performed, at least in part, concurrently with other operations. In another embodiment, instructions or sub-operations of distinct operations may be implemented in an intermittent and/or alternating manner.
The teachings of the disclosure provided herein can be applied to other systems, not necessarily the system described above. The elements and acts of the various embodiments described above can be combined to provide further embodiments. Any measurements or dimensions described or used herein are merely exemplary and not a limitation on the present invention. Other measurements or dimensions are within the scope of the invention.
Any patents and applications and other references noted above, including any that may be listed in accompanying filing papers, are incorporated herein by reference in their entirety. Aspects of the disclosure can be modified, if necessary, to employ the systems, functions, and concepts of the various references described above to provide yet further embodiments of the disclosure.
These and other changes can be made to the disclosure in light of the above Detailed Description of the Preferred Embodiments. While the above description describes certain embodiments of the disclosure, and describes the best mode contemplated, no matter how detailed the above appears in text, the teachings can be practiced in many ways. Details of the system may vary considerably in its implementation details, while still being encompassed by the subject matter disclosed herein. As noted above, particular terminology used when describing certain features or aspects of the disclosure should not be taken to imply that the terminology is being redefined herein to be restricted to any specific characteristics, features or aspects of the disclosure with which that terminology is associated. In general, the terms used in the following claims should not be construed to limit the disclosures to the specific embodiments disclosed in the specification unless the above Detailed Description of the Preferred Embodiments section explicitly defines such terms. Accordingly, the actual scope of the disclosure encompasses not only the disclosed embodiments, but also all equivalent ways of practicing or implementing the disclosure under the claims.
While certain aspects of the disclosure are presented below in certain claim forms, the inventors contemplate the various aspects of the disclosure in any number of claim forms. For example, while only one aspect of the disclosure is recited as a means-plus-function claim under 35 U.S.C. § 112, ¶6, other aspects may likewise be embodied as a means-plus-function claim, or in other forms, such as being embodied in a computer-readable medium. (Any claims intended to be treated under 35 U.S.C. § 112, ¶6 will include the words “means for”). Accordingly, the applicant reserves the right to add additional claims after filing the application to pursue such additional claim forms for other aspects of the disclosure.
Accordingly, although exemplary embodiments of the invention have been shown and described, it is to be understood that all the terms used herein are descriptive rather than limiting, and that many changes, modifications, and substitutions may be made by one having ordinary skill in the art without departing from the spirit and scope of the invention.
This application claims the benefit of U.S. Provisional Application No. 62/938,145, filed Nov. 20, 2019, and U.S. Provisional Application No. 62/955,209, filed Dec. 30, 2019 the entireties of which are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62938145 | Nov 2019 | US | |
| 62955209 | Dec 2019 | US |
