Patent Application
20230320850
All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
Blood flow between heart chambers is regulated by native valves—the mitral valve, the aortic valve, the pulmonary valve, and the tricuspid valve. Each of these valves is a passive one-way valve that opens and closes in response to differential pressures. Patients with valvular disease have abnormal anatomy and/or function of at least one valve. For example, a valve may suffer from insufficiency, also referred to as regurgitation, when the valve does not fully close, thereby allowing blood to flow retrograde. Valve stenosis can cause a valve to fail to open properly. Other diseases may also lead to dysfunction of the valves.
The mitral valve, for example, sits between the left atrium and the left ventricle and, when functioning properly, allows blood to flow from the left atrium to the left ventricle while preventing backflow or regurgitation in the reverse direction. Native valve leaflets of a diseased mitral valve, however, do not fully prolapse, causing the patient to experience regurgitation.
While medications may be used to treat diseased native valves, the defective valve often needs to be repaired or replaced at some point during the patient's lifetime. Existing prosthetic valves and surgical repair and/or replacement procedures may have increased risks, limited lifespans, and/or are highly invasive. Some less invasive transcatheter options are available, but most are not ideal. A major limitation of existing transcatheter mitral valve implantation methods, for example, is that a large number of catheters are required to be interchanged during the procedure, and maintaining hemostasis throughout the process can be challenging.
Thus, a new valve delivery system or method that overcomes some or all of these deficiencies is desired.
Described herein are systems, devices, and methods related to delivering heart valve prostheses into a patient's heart. A delivery system can include an access sheath that is configured to provide access into the patient's body and/or heart. The access sheath includes an inner lumen for accommodating one or more delivery catheters carrying one or more parts of the valve prosthesis. A handle is configured to provide interchangeable access for the one or more delivery catheters into the inner lumen of the access sheath.
According to some aspects, a delivery system for delivering a valve prosthesis comprises: one or more catheters holding at least a portion of the valve prosthesis therein; an access sheath having an inner lumen for accommodating the one or more catheters; and a handle coupled to a proximal end of the access sheath, the handle comprising a seal configured to accommodate the one or more catheters therethrough and to provide a hemostatic seal between an outer environment and the inner lumen of the access sheath.
In this aspect, the seal can be a disk-shaped insert having a first opening and a second opening, wherein the first opening has a first diameter that is configured to accept and seal with a first catheter, wherein the second opening has a second diameter that is configured to accept and seal with a second catheter.
According to some aspects, a delivery system for delivering a valve prosthesis comprises: one or more catheters holding at least a portion of the valve prosthesis therein; an access sheath having an inner lumen for accommodating the one or more catheters; a handle coupled to a proximal end of the access sheath, the handle configured to provide access for the one or more catheters distally through the access sheath; and a sheath bending component positioned around a circumference of the access sheath, the sheath bending component configured to controllably bend the access sheath.
In this aspect, the sheath bending component can include a hinge and a cable, wherein tensioning of the cable causes the hinge to bend, thereby causing the access sheath to bend accordingly.
These and other aspects are described herein.
Novel features of embodiments described herein are set forth with particularity in the appended claims. A better understanding of the features and advantages of the embodiments may be obtained by reference to the following detailed description that sets forth illustrative embodiments and the accompanying drawings.
Described herein are devices and methods for use in delivering a cardiac valve, for example during a mitral valve replacement.
In some embodiments, referring to
In still other embodiments, an access sheath can be used to deliver the cardiac valve surgically (e.g., via thoracotomy or sternotomy).
Referring to
Referring to
As shown in
The seal inserts described herein may include openings any size and are not limited to those shown in the exemplary seal insert 711. In some cases, the openings may be the same size. In addition, the seal insert 711 may include any number of openings (e.g., 1, 2, 3, 4, 5, 6 or more openings).
The seal assembly 706 can be configured so as to enable easy removal and replacement the seal insert 711 with one or more additional seal inserts during different stages and/or procedures of a medical intervention. For example, some medical interventions may require the use of a first catheter to perform a first procedure and a second catheter to perform a second procedure. In some cases, the first and second catheters may have different diameters. To accommodate differently sized catheters, the seal assembly 706 can include a first seal insert (e.g., 711) having an opening (e.g., 752) for accommodating the first catheter for the first procedure. After the first procedure is complete, the first catheter can be removed from the access sheath and the seal assembly 706. The proximal nut 726 may then be rotated to remove the first seal insert (e.g., 711) and be replaced with a second insert having an opening sized to accommodate the second catheter. After the second insert is secured within the seal assembly 706 (e.g., by reinserting/rethreading the proximal nut 726 into the valve body 725), the second catheter may be inserted within the seal assembly 706 and access sheath to perform the second procedure.
In some embodiments, the access sheaths described herein may be angled or bent in order to improve an entry angle into the patient's body.
Further, although described for use in a mitral valve replacement procedure, it should be understood that the access sheaths and hubs described herein could be used for a variety of medical procedures. For example, the access sheaths and hubs (e.g., including the interchangeable inserts and shut-off valves) can be used in any trans-catheter structural heart delivery system (such as for delivery of LAA occluders, aortic valves, mitral repair systems, and shunts). Similarly, the access sheaths and hubs can be used for delivery of neurological devices, including aneurysm coils, aspiration systems, and mechanical thrombectomy systems.
It should be understood that any feature described herein with respect to one embodiment can be used in addition to or in place of any feature described with respect to another embodiment.
When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. 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 have portions that overlap or underlie the adjacent feature.
Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, 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” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.
Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
Although the terms “first” and “second” may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.
As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/−0.1% of the stated value (or range of values), +/−1% of the stated value (or range of values), +/−2% of the stated value (or range of values), +/−5% of the stated value (or range of values), +/−10% of the stated value (or range of values), etc. Any numerical range recited herein is intended to include all sub-ranges subsumed therein.
Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.
The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
This application claims priority to U.S. Provisional Application No. 63/072,834, titled “ACCESS SHEATH FOR PROSTHETIC CARDIAC VALVE DELIVERY SYSTEMS,” filed Aug. 31, 2020, the entirety of which is incorporated by reference herein.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US21/47958 | 8/27/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63072834 | Aug 2020 | US |
