STENTED PROSTHESIS DELIVERY SYSTEM HAVING A BUMPER
Numerous delivery devices for delivery of a stented prosthesis, such as a stented prosthetic heart valve. Various delivery devices include a capsule that is advanced proximally to retain the stented prosthesis, which is secured over an inner shaft assembly of the delivery device. The delivery device further includes a bumper or bumper assembly to provide a smooth transition of the capsule over the stented prosthesis. In some alternate disclosed embodiments, the bumper further serves to connect various elements of the inner shaft assembly. Additional embodiments include a bumper assembly arranged and configured to longitudinally expand and contract to substantially fill any open space as the capsule is retracted from the stented prosthesis, which prevents kinking in the capsule. Additional embodiments include proximal and/or distal bumpers for temporarily covering and smoothing the ends of the stented prosthesis as part of a delivery device that does not include a capsule.
This application is a continuation of U.S. application Ser. No. 17/121,903, filed Dec. 15, 2020, which is a continuation of U.S. application Ser. No. 15/449,471 filed Mar. 3, 2017, now U.S. Pat. No. 10,893,938, which claims the benefit of U.S. Provisional Application No. 62/303,274, filed Mar. 3, 2016, the entire contents of each application which are incorporated herein by reference.
BACKGROUNDThe disclosure relates to delivery devices for stented prosthesis (e.g., stented prosthetic heart valve) loading and implantation. More particularly, the present disclosure provides for delivery devices that prevent a proximal end of the stented prosthesis from catching or snagging on the delivery device or causing injury to the patient.
A human heart includes four heart valves that determine the pathway of blood flow through the heart: the mitral valve, the tricuspid valve, the aortic valve, and the pulmonary valve. The mitral and tricuspid valves are atrio-ventricular valves, which are between the atria and the ventricles, while the aortic and pulmonary valves are semilunar valves, which are in the arteries leaving the heart. Ideally, native leaflets of a heart valve move apart from each other when the valve is in an open position, and meet or “coapt” when the valve is in a closed position. Problems that may develop with valves include stenosis in which a valve does not open properly, and/or insufficiency or regurgitation in which a valve does not close properly. Stenosis and insufficiency may occur concomitantly in the same valve. The effects of valvular dysfunction vary, with regurgitation or backflow typically having relatively severe physiological consequences to the patient.
Diseased or otherwise deficient heart valves can be repaired or replaced using a variety of different types of heart valve surgeries. One conventional technique involves an open-heart surgical approach that is conducted under general anesthesia, during which the heart is stopped and blood flow is controlled by a heart-lung bypass machine.
More recently, minimally invasive approaches have been developed to facilitate catheter-based implantation of the valve prosthesis on the beating heart, intending to obviate the need for the use of classical sternotomy and cardiopulmonary bypass. In general terms, an expandable valve prosthesis is compressed about or within a catheter, inserted inside a body lumen of the patient, such as the femoral artery, and delivered to a desired location in the heart where the valve prosthesis is then deployed.
The present disclosure presents improvements directed to the related art.
SUMMARYThe present disclosure relates to numerous delivery devices and methods for stented prosthesis or stented prosthetic heart valve (hereinafter “prosthetic valve”) loading and implantation. Various delivery devices can include an outer sheath assembly, an inner shaft assembly and a handle assembly. The delivery device provides a loaded delivery arrangement in which the prosthetic valve is loaded and compressed over the inner shaft assembly. Compressive tension of the prosthetic valve can be varied and adjusted with one or more elongate tension members actuated by the handle assembly. In this way, the delivery device can be manipulated to permit the prosthetic valve to self-expand and partially release from the inner shaft assembly.
When compressed, most stented prosthesis and stented prosthetic heart valve designs have a rough outer surface, which can cause damage to the patient during delivery to a native heart valve or other target site. Therefore, various embodiments disclosed herein include a delivery device having a protective sheath or capsule covering the outer surface of the prosthetic valve until the prosthetic valve is in position and ready to be deployed. Capsules, however, can snag on a proximal end of the prosthetic valve when the capsule is advanced over the prosthetic valve during loading or recapture of the prosthetic valve within the capsule. In various disclosed embodiments, the delivery device includes a bumper to provide a smooth transition of the capsule over the prosthetic valve. In some alternate disclosed embodiments, the bumper further serves to connect various elements of the inner shaft assembly.
Further disclosed embodiments include a bumper assembly having at least one bumper and a biasing member positioned within the capsule of the delivery device. The bumper assembly is arranged and configured to longitudinally expand and contract to substantially fill any open space as the capsule is retracted from the prosthetic valve, which prevents kinking in the capsule.
Other disclosed embodiments are designed for use with a delivery device that does not include a capsule. These embodiments include a proximal and an optional distal bumper that each smooth respective edges of the prosthetic valve during delivery.
Methods of loading the stented prosthesis to the disclosed delivery devices are also disclosed.
Specific embodiments of the present disclosure are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” or “distally” are a position distant from or in a direction away from the clinician. “Proximal” and “proximally” are a position near or in a direction toward the clinician.
As described below, some aspects of the present disclosure relate to transcatheter stented prosthetic heart valve delivery devices utilizing one or more elongate tension members to retain the stented prosthetic heart valve during delivery to a target site. It will be understood that the delivery devices can also be used to deliver other stented prostheses as well in a similar manner. By way of background, general components of one non-limiting example of a delivery device 10 with which some embodiments of the present disclosure are useful are illustrated in
As referred to herein, stented prostheses, stented prosthetic heart valves or “prosthetic valves” useful with the various devices and methods of the present disclosure may assume a wide variety of configurations. Stented prosthetic heart valves can include, for example, a bioprosthetic heart valve having tissue leaflets or a synthetic heart valve having polymeric, metallic or tissue-engineered leaflets, and can be specifically configured for replacing valves of the human heart. The prosthetic valves and stented prostheses of the present disclosure may be self-expandable, balloon expandable and/or mechanically expandable or combinations thereof. In general terms, the prosthetic valves of the present disclosure include a stent or stent frame having an internal lumen maintaining a valve structure (tissue or synthetic), with the stent frame having a normal, expanded condition or arrangement and collapsible to a compressed condition or arrangement for loading within the delivery device. For example, the stents or stent frames are support structures that comprise a number of struts or wire segments arranged relative to each other to provide a desired compressibility and strength to the prosthetic valve. The struts or wire segments are arranged such that they are capable of self-transitioning from, or being forced from, a compressed or collapsed arrangement to a normal, radially expanded arrangement. The struts or wire segments can be formed from a shape memory material, such as a nickel titanium alloy (e.g., Nitinol™). The stent frame can be laser-cut from a single piece of material, or can be assembled from a number of discrete components.
One non-limiting example of a stented prosthesis, that being a stented prosthetic heart valve 30, is illustrated in
If provided, the valve structure 34 can assume a variety of forms, and can be formed, for example, from one or more biocompatible synthetic materials, synthetic polymers, autograft tissue, homograft tissue, xenograft tissue, or one or more other suitable materials. In some embodiments, the valve structure 34 can be formed, for example, from bovine, porcine, equine, ovine and/or other suitable animal tissues. In some embodiments, the valve structure 34 is formed, for example, from heart valve tissue, pericardium, and/or other suitable tissue. In some embodiments, the valve structure 34 can include or form one or more leaflets 36. For example, the valve structure 34 can be in the form of a tri-leaflet bovine pericardium valve, a bi-leaflet valve, or another suitable valve.
In some prosthetic valve constructions, such as that of
The delivery device 110 also includes a bumper 160 defining a cavity 180 that is threaded over the inner shaft assembly 116. The bumper 160 is optionally secured to a middle tube 126 that is longitudinally fixed with respect to the inner shaft assembly 116. The bumper 160 is positioned adjacent the most proximal aperture 128 so that when the prosthetic valve 30 is secured on the distal portion 122 and the outer sheath assembly 114 is retracted as is shown in
Once the prosthetic valve 30 is loaded onto the distal portion 122 adjacent the bumper 160, the capsule 124 of the outer sheath assembly 114 is positioned over the prosthetic valve 30 as is shown in
The delivery device 210 of
The delivery device 310 further includes a bumper 360 defining a cavity 380 threaded over the inner shaft assembly 316. The bumper 360 is secured to an optional middle tube 326. In either configuration, the bumper 360 includes a ramped surface 378 that ensures a smooth transition as the capsule 324 advances over the bumper 360 and over the prosthetic valve 30. As seen in
Turning now also to
The delivery device 410 also includes a bumper assembly 460 having a distal bumper 466 secured to a distal end 470 of a biasing member 468 positioned within the capsule 424 and a proximal bumper 474 secured to a proximal end 472 of the biasing member 468. The distal bumper 466 is fixed to the inner shaft assembly 416 and the proximal bumper 464 is configured to slide along a length of the inner shaft assembly 416, within the capsule 424. Alternatively, the proximal bumper 464 is fixed to the inner shaft assembly 416 and the distal bumper 466 can translate freely within the capsule 424 during loading and recapture of the stent frame 32. As can be seen in
The bumper assembly 460 is provided, in part, to provide a smooth transition and ease loading of the stent frame 32 within the capsule 424. As discussed above with respect to prior embodiments, various features 48 at the end 40 of the stent frame 32 can catch on the capsule 424 during sheathing of the prosthetic valve 30 within the capsule 424. The bumper assembly 460 provides a distal bumper 466 having an outer diameter DD3 that is slightly less than an inner diameter of the capsule ID3 but greater than the outer diameter VD of the compressed prosthetic valve 30.
The bumper assembly 460 is also configured to deflect the capsule 424 away from the inner shaft assembly 416 of the delivery device 410 and to provide kink resistance to the capsule 424. As the capsule 424 is retracted proximally to expose the stent frame 32, the biasing member 468 expands to fill a volume of the capsule 424 that would otherwise be open between the stent frame 32 and a proximal end 452 of the capsule 424. The bumper assembly 460 is beneficial in that it increases the strength of the capsule 424 without increasing the profile of the capsule 424 during delivery.
As shown in
Once the prosthetic valve 30 is compressed, the outer sheath assembly 414 is advanced distally over the distal bumper 466 and over the prosthetic valve 30 as is generally illustrated in
To fully load and sheathe the prosthetic valve 30, the outer sheath assembly 414 is further advanced distally until the prosthetic valve 30 is entirely sheathed by the capsule 424 as is seen in
By way of background,
When provided, each of the proximal and distal bumpers 664, 666 are arranged and configured to cover at least a portion of the respective first and second ends 40, 44, which may include rough or jagged features 48 (e.g., crowns and/or eyelets). In some embodiments, as shown in
Although the present disclosure has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the present disclosure.
Claims
1. A delivery device for delivering a stented prosthesis to a target site, the delivery device comprising:
- an inner shaft assembly comprising a distal portion configured to receive the stented prosthesis;
- a middle tube defining a recess within which the inner shaft assembly is received such that the middle tube is configured to be slidable relative to the inner shaft assembly; and
- a bumper attached to an end of the middle tube and defining a cavity within which the inner shaft assembly is received such that the bumper is configured to be slidable relative to the inner shaft assembly, the bumper extending between a distal end and a proximal end, the distal end of the bumper configured to receive a proximal end of the stented prosthesis within the cavity such that the stented prosthesis is maintained in a radially-compressed configuration.
2. The delivery device of claim 1, wherein the bumper comprises a ramped surface with an increasing diameter from the proximal end of the bumper toward the distal end of the bumper.
3. The delivery device of claim 1, wherein a first segment of the stented prosthesis is received within the cavity such that the bumper circumferentially surrounds the first segment, and wherein a second segment of the stented prosthesis is located outside of the bumper such that the second segment is not circumferentially surrounded by the bumper.
4. The delivery device of claim 1, wherein the inner shaft member comprises a plurality of apertures extending radially through the inner shaft member.
5. The delivery device of claim 4, further comprising one or more tension members extending through the plurality of apertures, the one or more tension members circumferentially surrounding the stented prosthesis and configured to maintain the stented prosthesis in the radially-compressed configuration.
6. The delivery device of claim 1, the bumper comprising a distal outer diameter that is greater than a compressed diameter of the stented prosthesis in the radially-compressed configuration.
7. The delivery device of claim 1, further comprising a capsule comprising an elongated channel within which the bumper and the stented prosthesis are received.
8. A delivery device for delivering a stented prosthesis to a target site, the delivery device comprising:
- an inner shaft assembly comprising a distal portion configured to receive the stented prosthesis;
- a middle tube defining a recess within which the inner shaft assembly is received such that the middle tube is configured to be slidable relative to the inner shaft assembly;
- a bumper attached to an end of the middle tube and defining a cavity within which the inner shaft assembly is received such that the bumper is configured to be slidable relative to the inner shaft assembly, the bumper extending between a distal end and a proximal end, and comprising a ramped surface with an increasing diameter from the proximal end toward the distal end with the distal end comprising a distal outer diameter, the bumper configured to receive a proximal end of the stented prosthesis within the cavity such that the stented prosthesis is maintained in a radially-compressed configuration; and
- a capsule comprising an elongated channel within which the middle tube is received such that the capsule is configured to be slidable relative to the middle tube, the inner shaft assembly, and the bumper, the elongated channel comprising an inner diameter that is greater than the distal outer diameter of the bumper such that the capsule receives the bumper and the stented prosthesis when the capsule moves in a distal direction.
9. The delivery device of claim 8, wherein a first segment of the stented prosthesis is received within the cavity such that the bumper circumferentially surrounds the first segment, and wherein a second segment of the stented prosthesis is located outside of the bumper such that the second segment is not circumferentially surrounded by the bumper.
10. The delivery device of claim 9, wherein the distal outer diameter of the bumper is greater than a compressed diameter of the stented prosthesis in the radially-compressed configuration.
11. The delivery device of claim 8, wherein the inner shaft member comprises a plurality of apertures extending radially through the inner shaft member.
12. The delivery device of claim 11, further comprising one or more tension members extending through the plurality of apertures, the one or more tension members circumferentially surrounding the stented prosthesis and configured to maintain the stented prosthesis in the radially-compressed configuration.
13. The delivery device of claim 8, wherein the capsule is configured to move between a first position, in which the bumper and the stented prosthesis are received within the elongated channel, and a second position, in which the bumper and the stented prosthesis are outside of the elongated channel.
14. A method for delivering a stented prosthesis to a target site, the method comprising:
- providing a delivery device comprising: an inner shaft assembly; a middle tube defining a recess within which the inner shaft assembly is received; a bumper attached to an end of the middle tube and defining a cavity within which the inner shaft assembly is received; and a capsule comprising an elongated channel within which the middle tube is received;
- loading a stented prosthesis over the inner shaft assembly;
- radially-compressing the stented prosthesis;
- moving the bumper in a distal direction toward the stented prosthesis such that a proximal end of the stented prosthesis is received within the cavity and the stented prosthesis is maintained in the radially-compressed configuration; and
- moving the capsule in the distal direction toward the stented prosthesis such that the bumper and the stented prosthesis are received within the elongated channel.
15. The method of claim 14, further comprising, after the bumper and the stented prosthesis are received within the elongated channel, moving the delivery device to the target site while the bumper and the stented prosthesis are maintained within the elongated channel.
16. The method of claim 15, further comprising, after moving the delivery device to the target site, moving the capsule in a proximal direction, opposite the distal direction, such that the bumper and the stented prosthesis are not received within the elongated channel.
17. The method of claim 14, further comprising extending one or more tension members through a plurality of apertures of the inner shaft member such that the one or more tension members circumferentially surround the stented prosthesis.
18. The method of claim 17, wherein radially-compressing the stented prosthesis comprises tightening the one or more tension members around the stented prosthesis to radially-compress the stented prosthesis.
19. The method of claim 14, wherein the bumper comprises a ramped surface with an increasing diameter from a proximal end of the bumper toward a distal end of the bumper, the capsule guided by the ramped surface as the capsule moves in the distal direction.
20. The method of claim 19, wherein moving the capsule in the distal direction comprises moving the capsule relative to the inner shaft assembly, the middle tube, and the bumper.
Type: Application
Filed: Sep 29, 2023
Publication Date: Jan 18, 2024
Inventors: Don Tran (Westminster, CA), Martha Barajas-Torres (Santa Rosa, CA), Marian Lally (Galway), Michael Gloss (Minneapolis, MN), Timothy Groen (Rush City, MN), Leonel Mendoza (Santa Rosa, CA), Siyan Som (Fulton, CA), Michele Silver (Blaine, MN), Nathan Brown (Santa Rosa, CA), Jill Mendelson (San Francisco, CA)
Application Number: 18/374,845