Patent Description:
A variety of maladies may affect an individual's body. Such maladies may be of the individual's heart, and may include maladies of the individual's heart valves, including the aortic, mitral, tricuspid, and pulmonary valves. Stenosis, for example, is a common and serious valve disease that may affect the operation of the heart valves and an individual's overall well-being.

Implants may be provided that may replace or repair portions of a patient's heart. Prosthetic implants, such as prosthetic valves, may be provided to replace a portion of a patient's heart. Prosthetic aortic, mitral, tricuspid, and even pulmonary valves may be provided.

Implants may be deployed to the desired portion of the patient's body percutaneously, in a minimally invasive manner. Such deployment may occur transcatheter, in which a catheter may be deployed through the vasculature of an individual.

Such implants may have a range of working diameters that the implants are effectively utilized at. For example, a prosthetic heart valve may be able to effectively operate within a working diameter range. The range, however, may be relatively low, as care must be taken not to over-expand or under-expand a prosthetic heart valve. Over-expansion or under-expansion may lead to the inability of the valve leaflets of the prosthetic heart valve to coapt properly. Further issues may arise from an over-expansion or under-expansion of a prosthetic heart valve or other types of implants, including damage to the implant, dislodgement of the implant, or other issues arising from the implant being over-expanded or under-expanded.

To address such issues, practitioners typically select an implant from an array of implants having different working diameters or ranges of working diameters. The working diameter of the implant is typically selected according to the diameter of the treatment site within the patient's body. Due to variation in the possible diameter of the treatment site in the patient's body, however, a practitioner may keep a large number of different implants on hand, which may be expensive and cumbersome. Further, such implants may still be utilized within a range of working diameters upon implantation. For example, if the implant is to be implanted within a portion of the body having a diameter of <NUM> millimeters, the practitioner may have available a <NUM> millimeter implant and a <NUM> millimeter implant, and may select the <NUM> millimeter diameter implant to expand to a working diameter of <NUM> millimeters, because a <NUM> millimeter implant may be too expensive to separately stock.

<CIT> relates to unexpandable docking stations for docking an expandable valve which can include a valve seat, one or more sealing portions, and one or more retaining portions. The valve seat can be unexpandable or substantially unexpandable beyond a deployed size. The one or more sealing portions are connected to the valve seat and extend radially outward of the valve seat. The one or more sealing portions are constructed to expand outward of the valve seat and provide a seal over a range of sizes. The one or more retaining portions are connected to the one or more sealing portions. The one or more retaining portions are configured to retain the docking station at a deployed position.

<CIT> relates to a two-stage or component-based valve prosthesis. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body.

<CIT> relates to a cardiovascular valve assembly comprised of a base member and an exchangeable valve member detachably mountable thereto. The base member includes a tubular body. The valve member includes a valve frame that supports a plurality of valve leaflets. The diameter of the tubular body can be increased to receive an exchangeable valve member having larger dimensions.

The aspect of the presently claimed invention is set out in the independent claim. Particular embodiments of this aspect is set out in the dependent claims.

Improvements accordingly may be desired in addressing implants and the diameters of implants to be deployed to portions of a patient's body. Embodiments as disclosed herein may provide for increased flexibility of providing prosthetic implants having various working diameters, and for reducing expense associated with keeping a stock of prosthetic implants at various working diameters.

Disclosed herein is a prosthetic valve having a docking frame that may have a relatively large range of working diameters. A valve frame is configured to dock with the docking frame. The valve frame may have a working diameter that is closely tailored to the diameter of the implantation site. Further, the valve frame may have a lesser working diameter range than the working diameter range of the docking frame. As disclosed herein, the valve frame may be optimized to operate at the diameter of the implantation site.

Further, the docking frame may comprise a sturdier and robust structure than the valve frame, able to withstand the force exerted radially outward from the prosthetic valve during and following a deployment that may anchor the prosthetic valve in position. The valve frame accordingly may involve less material than a full prosthetic valve, and thus may be less expensive and complicated to manufacture. As such, a user may be able to stock a larger number and variation in the size of valve frames than may have been previously stocked with full prosthetic valves, due to a relatively reduced cost of the individual valve frames versus the full prosthetic valves.

As disclosed herein, the valve frame docks to the docking frame in a manner that locks the diameter and axial length of the docking frame in position. The valve frame accordingly is utilized to resist radial compression of the docking frame by the patient's body, and may maintain a force applied radially outward from the docking frame in an expanded state.

As disclosed herein, a prosthetic valve system includes a docking frame configured to be implanted within a portion of a patient's body. A valve frame may have an outer surface and an inner surface and may be configured to dock to the docking frame to support the valve frame within the portion of the patient's body. A plurality of valve leaflets are coupled to the valve frame and configured to extend radially inward from the inner surface of the valve frame.

As disclosed herein, a method may include deploying a docking frame within a portion of a patient's body. The method may include deploying a valve frame such that the valve frame is docked to the docking frame and the docking frame supports the valve frame within the portion of the patient's body, a plurality of valve leaflets being coupled to the valve frame and extending radially inward from an inner surface of the valve frame.

These and other features, aspects, and advantages are described below with reference to the drawings, which are intended to illustrate, but not to limit, the disclosure. In the drawings, like reference characters denote corresponding features consistently throughout similar embodiments.

The invention relates to a prosthetic valve system as illustrated in <FIG>.

The following description and examples illustrate some example embodiments of the disclosure in detail. Those of skill in the art will recognize that there are numerous variations and modifications of the disclosure that are encompassed by its scope. Accordingly, the description of a certain example embodiment should not be deemed to limit the scope of the present disclosure.

<FIG> illustrates a perspective view of an implant in the form of a docking frame <NUM> that may be utilized according to embodiments herein. The docking frame <NUM> may be utilized as part of a system that may comprise a prosthetic valve system. The docking frame <NUM> may include a proximal end <NUM> and a distal end <NUM> and may have a length <NUM> (marked in <FIG>) therebetween. The docking frame <NUM> may be configured to be implanted within a portion of a patient's body.

The docking frame <NUM> may have an outer surface <NUM> and an inner surface <NUM> (marked in <FIG>). The outer surface <NUM> may be configured to contact a portion of a patient's body to which the docking frame <NUM> is implanted and may comprise an anchoring surface. The outer surface <NUM> may be configured to apply a radially outward force to the portion of the patient's body to which the docking frame <NUM> is implanted. The inner surface <NUM> may be configured to surround a valve frame that the docking frame <NUM> is docked to in embodiments, and may face an interior flow channel <NUM> of the valve frame (as marked in <FIG>).

The docking frame <NUM> may include a frame body <NUM> that may be formed by a plurality of struts <NUM> separated by spaces in the forms of openings <NUM>. The struts <NUM> may join together at junctures to form a repeating pattern of cells extending circumferentially about the axis that the frame body <NUM> surrounds.

The docking frame <NUM> may have a cylindrical shape as shown in <FIG> or may have a variety of other shapes as desired. For example, the docking frame <NUM> may have a "V" shape or bulb shape, or other shape, in embodiments as desired.

The docking frame <NUM> may be configured to be radially expandable. The docking frame <NUM> may be configured to move from a compressed (or unexpanded or undeployed) state to an expanded (or deployed) state. The docking frame <NUM> may be configured to expand radially outward from an axis that the frame body <NUM> surrounds. In embodiments, the outward radial expansion of the frame body <NUM> may result in the length <NUM> decreasing, with an increase in the width or diameter <NUM> of the docking frame <NUM>. Such an operation may occur in a variety of manners.

For example, as shown in <FIG>, the junctures of the struts <NUM> may comprise hinges <NUM>. Each hinge <NUM> may allow the struts <NUM> to pivot about the hinge <NUM> such that a width of each of the openings <NUM> between the struts <NUM> increases as the length of the openings <NUM> decreases. Such a decrease in length and increase in width may allow the length <NUM> of the entire docking frame <NUM> to decrease and the width or diameter <NUM> to increase. The docking frame <NUM> may further be configured such that a reverse operation of decreasing the width of the openings <NUM> and increasing the length of the openings <NUM> allows the docking frame <NUM> to contract to the compressed, undeployed, or unexpanded state.

A variety of mechanisms may be utilized to control expansion and contraction of the docking frame <NUM>. In embodiments, the docking frame <NUM> may comprise a mechanically expandable frame. As shown in <FIG>, in embodiments a mechanism may be utilized to expand and contract the mechanically expandable frame, which may be a mechanical drive that couples to the docking frame <NUM>. The mechanical drive may include a plurality of drive rods <NUM> that may couple to the docking frame <NUM> and be configured to rotate to control the expansion and contraction of the docking frame <NUM>. Upon the docking frame <NUM> being expanded to the desired diameter, the drive rods <NUM> may decouple from the docking frame <NUM>. Such an operation is disclosed in <CIT> and issued March <NUM>, <NUM>. <NUM>-<NUM> of <CIT>, for example, illustrate such an operation and decoupling of a frame from drive rods. Further, such a mechanism may include a locking mechanism, as disclosed in <CIT>, which may be utilized to lock the position of the expansion of the docking frame <NUM>.

The docking frame <NUM> may have a relatively large working diameter range. Such a large range may be allowed due to the construction of the docking frame <NUM>, and due to the lack of valve leaflets coupled to the docking frame <NUM>. As such, the docking frame <NUM> may be operably expanded to a relatively large range of working diameters and be effectively implanted within a patient's body. As an example, the working diameter range may be <NUM> millimeters in embodiments, or between working diameters of <NUM> millimeters and <NUM> millimeters. In other embodiments, greater or lesser working diameter ranges may be utilized, and the greatest working diameter (here <NUM> millimeters) and smallest working diameter (here <NUM> millimeters) may be greater or lesser in embodiments as desired. The greatest working diameter may be the greatest diameter that the docking frame <NUM> may operate effectively at, and the smallest working diameter may be the smallest diameter that the docking frame <NUM> may operate effectively at.

In embodiments, the docking frame <NUM> may be configured to be balloon expandable, or may be self-expanding, among other methods of expansion.

<FIG> illustrates the docking frame <NUM> coupled to a delivery shaft <NUM> of a delivery apparatus for the docking frame <NUM>. A delivery apparatus that may be utilized is shown in <FIG>, for example. Other forms of delivery apparatuses may be utilized as desired. The docking frame <NUM> may be released from the delivery shaft upon deployment, for example as disclosed in <CIT> (as shown in FIGS. <NUM>-<NUM>). The docking frame <NUM> may be positioned within the desired portion of the patient's body (e.g., within the patient's vasculature), and then expanded within such a portion. The delivery shaft <NUM> may then be withdrawn from the patient's body. Other methods of delivery may be utilized as desired.

<FIG> illustrates a cross sectional view of an embodiment of a valve frame <NUM> that may be utilized according to embodiments herein. The valve frame <NUM> may be utilized as part of a system that may comprise a prosthetic valve system. The valve frame <NUM> may be configured to dock to the docking frame <NUM> to support the valve frame <NUM> within the portion of the patient's body.

The valve frame <NUM> may include a proximal end <NUM>, a distal end <NUM>, and a length <NUM> therebetween. The valve frame <NUM> may have an outer surface <NUM> and an inner surface <NUM>. The outer surface <NUM> may be configured to face outward, towards the surface of the implantation site of the patient's body, and may face towards the inner surface <NUM> of the docking frame <NUM> in embodiments. The inner surface <NUM> may face towards a flow channel <NUM> within the valve frame <NUM>. In embodiments, the valve frame <NUM> may include openings <NUM> that the docking frame <NUM> may be positioned within. The openings <NUM> may be positioned in the body <NUM> of the valve frame <NUM> and may comprise cut-outs in the outer surface <NUM> of the valve frame <NUM>.

A plurality of leaflets <NUM> may be coupled to the valve frame <NUM> and positioned within the flow channel <NUM>. Two leaflets <NUM> are represented in <FIG>, although in embodiments three leaflets or a greater number may be utilized as desired. The leaflets <NUM> may extend radially inward from the inner surface <NUM> of the valve frame <NUM>. The leaflets <NUM> may be configured to move towards each other to close flow through the valve frame <NUM>, and may be configured to move radially away from each other to open flow through the valve frame <NUM>. The proximal end <NUM> of the valve frame <NUM> may comprise an outflow end, and the distal end <NUM> of the valve frame <NUM> may comprise an inflow end. The leaflets <NUM> may move between opened and closed states in a similar manner that native leaflets within a patient's body may perform. The leaflets <NUM> may control flow within the flow channel <NUM>.

Similar to the docking frame <NUM>, the valve frame <NUM> may be configured to be radially expandable. The valve frame <NUM> may include a frame body <NUM> that may be formed by a plurality of struts <NUM> separated by spaces in the forms of openings <NUM>. The struts <NUM> may join together at junctures to form a repeating pattern of cells extending circumferentially about the axis that the valve frame <NUM> surrounds.

The valve frame <NUM> may be configured to move from a compressed (or unexpanded or undeployed) state to an expanded (or deployed) state. The valve frame <NUM> may be configured to expand radially outward from an axis that the frame body <NUM> surrounds. In embodiments, the radial expansion of the frame body <NUM> may cause the length <NUM> to decrease with an increase in the width or diameter <NUM> of the valve frame <NUM>. Such an operation may occur in a variety of manners.

The junctures of the struts <NUM> may be flexible, or may comprise a hinge as disclosed in regard to <FIG>. Each juncture may allow the struts <NUM> to pivot about the juncture such that a width of each of the openings <NUM> between the struts <NUM> increases as the length of the openings decreases. Such a decrease in length and increase in width may allow the length <NUM> of the entire valve frame <NUM> to decrease and the width or diameter <NUM> to increase. The valve frame <NUM> may further be configured such that a reverse operation of decreasing the width of the openings <NUM> and increasing the length of the openings <NUM> allows the valve frame <NUM> to contract to the undeployed or unexpanded state.

The valve frame <NUM> may have a cylindrical shape (half of which is shown in <FIG>), similar to the docking frame <NUM> as shown in <FIG> or may have a variety of other shapes as desired. For example, the valve frame <NUM> may have a "V" shape or bulb shape in embodiments as desired.

The valve frame <NUM> may have a working diameter range. The range may extend between the greatest working diameter of the valve frame <NUM> and the smallest working diameter of the valve frame. In embodiments, the working diameter range of the docking frame <NUM> may be greater than a working diameter range of the valve frame <NUM>. The working diameter range of the valve frame <NUM> may be less than the range of the docking frame <NUM> because leaflets <NUM> are coupled to the valve frame <NUM> that may be required to properly coapt during operation of the prosthetic valve, and thus the valve frame <NUM> may only operate within a defined range, which may be less than the range of operation of the docking frame <NUM>. Further, the valve frame <NUM> may be less sturdy than the docking frame <NUM>, which may reduce the amount that the valve frame <NUM> can expand and thus reduce working diameter range of the valve frame <NUM> relative to the working diameter range of the docking frame <NUM>. For example, the valve frame <NUM> may have a working diameter range of three millimeters in embodiments (e.g., between <NUM> and <NUM> millimeters). In embodiments, the working diameter range may be less than three millimeters (e.g., two millimeter, one millimeter, or lesser), or may be greater. The greatest working diameter of the docking frame <NUM> may also be greater than the greatest working diameter of the valve frame <NUM>, as the docking frame <NUM> may have an ability to operably expand to a greater diameter. The greatest working diameter of the valve frame <NUM> for example, may be <NUM> millimeters and the greatest working diameter of the docking frame <NUM> may be <NUM> millimeters for example. Other values may be utilized in embodiments as desired.

The valve frame <NUM> may be configured to be utilized with the docking frame <NUM> in a system within the patient's body. The docking frame <NUM> may be configured to be more robust and sturdy than the valve frame <NUM>, and able to better withstand compressive forces applied to the system, which may be as a result of the radial expansion forces applied to the patient's body by the docking frame <NUM>. The valve frame <NUM> may be configured to dock to the docking frame <NUM> and support the leaflets <NUM> within the portion of the patient's body.

The valve frame <NUM> may be configured to be docked to the docking frame <NUM> within the patient's body, or may be configured to be docked to the docking frame <NUM> external to the patient's body and prior to insertion of the docking frame <NUM> within the patient's body in embodiments.

<FIG> illustrate features of a method of utilizing a system disclosed herein. The system may be deployed to a portion of a patient's body comprising the patient's vasculature, which may comprise the patient's arteries or other venous bodies. The system may be utilized as a prosthetic valve system, which may be utilized to replace or augment the operation of a native heart valve of the patient's body. The portion of the patient's body accordingly may comprise a native aortic valve, or in embodiments may comprise another valve such as the mitral, tricuspid, or pulmonary valve. The system may be deployed to the annulus of the native valve as desired, or another location.

<FIG> represents the system being deployed to the native aortic valve, although the structure of the native aortic valve is not shown for clarity. The walls of the aorta <NUM> are shown in <FIG>, including a surface <NUM> of the aorta <NUM>, or surface of the heart valve annulus, to which the system is deployed.

The system may be deployed in a sequence of steps, in which the docking frame <NUM> may be deployed within a portion of the patient's body first, with the valve frame <NUM> following. In other embodiments herein, the docking frame <NUM> may be deployed with the valve frame <NUM>.

In embodiments, the system may be deployed in an implantation procedure without pre-visualization or pre-computed tomography (CT) being performed of the patient. In certain procedures, pre-CT is performed to determine the size of the patient's vasculature, to determine what size of implant to be implanted within the patient's vasculature. Such visualization is typically performed because the user (e.g., a medical clinician such as a surgeon) must select a size of implant to deploy within the patient's body and thus must know prior to the implantation procedure what is the size of the patient's vasculature. In embodiments herein however, the system may be deployed without such pre-visualization of the size of the patient's vasculature occurring. Such a feature may reduce the number of visits that the patient must make to a medical clinician (such as a medical imaging clinician), and may simplify the implantation process. Such a feature may be allowed as the docking frame <NUM> may be configured to expand to a variety of working diameters.

As such, referring to <FIG>, the docking frame <NUM> may be passed into the patient's body mounted to a delivery apparatus (with a delivery shaft <NUM> of a delivery apparatus shown in <FIG>). The docking frame <NUM> may then be deployed to the patient's vasculature and expanded radially outward to a diameter <NUM> as shown in <FIG>. The outer surface <NUM> of the docking frame <NUM> may be radially pressed outward against the inner surface <NUM> of the patient's vasculature.

The docking frame <NUM> may be configured to expand to a variety of working diameters, and may be capable of expanding to a greater diameter if the surface of the patient's vasculature did not block the docking frame <NUM>. Diameter <NUM> shown in <FIG>, for example, represents a greatest working diameter of the docking frame <NUM> that the frame <NUM> may operably expand to. The docking frame <NUM>, however, as shown in <FIG> only expands to the working diameter <NUM>, as such a diameter fits the diameter of the patient's vasculature. As discussed, the docking frame <NUM> may further have a working diameter that is less than the diameter <NUM>. During radial expansion of the docking frame <NUM>, a medical clinician may visualize the deployment of the docking frame <NUM> via an imaging device (e.g., fluoroscopy, echocardiography, or a combination thereof) to determine if the docking frame <NUM> is deployed in the desired position of the patient's body.

The docking frame <NUM> may further be visualized during the implantation procedure to determine the diameter <NUM> that the docking frame <NUM> is expanded to. Such a diameter may be measured through the imaging devices, such that the medical clinician is aware of the diameter <NUM> of the docking frame <NUM>. In embodiments, other methods to determine the diameter <NUM> may be utilized solely or in combination, including a force meter utilized by the delivery apparatus, or other method of determining a force applied by the docking frame <NUM> to the vasculature. In embodiments in which the docking frame <NUM> is mechanically deployed, a number of turns of the drive rods <NUM> may be measured and utilized to determine an amount of expansion of the docking frame <NUM>, and the diameter <NUM> of the implantation site.

In embodiments, a locking mechanism may be utilized to hold the radial expansion of the docking frame <NUM>, such as disclosed in <CIT>. In embodiments, the delivery apparatus that delivered the docking frame <NUM> may hold the docking frame <NUM> in position while the valve frame <NUM> is delivered to the docking frame <NUM>. In embodiments, the docking frame <NUM> may be balloon expandable or self-expanding, and thus may hold in position within the patient's vasculature as the valve frame <NUM> is delivered.

A medical clinician may determine the diameter <NUM> that the docking frame <NUM> has expanded to, and thus may select a valve frame <NUM> to be deployed to the docking frame <NUM> based on the diameter <NUM>. The valve frame <NUM> may be selected to have a working diameter that fits the determined diameter <NUM> that the docking frame <NUM> has expanded to (which may be the diameter of the implantation site). The selected working diameter of the valve frame <NUM> accordingly may be less than the greatest working diameter <NUM> that the docking frame <NUM> is capable of expanding outward to, as the diameter <NUM> is less than such a diameter <NUM>.

The valve frame <NUM> selected may be tailored to function at the selected diameter <NUM>. As such, the leaflets <NUM> of the valve frame <NUM> may be configured to function at the selected diameter <NUM>, with effective coaptation between the leaflets <NUM>. The working diameter of the valve frame <NUM> may fit the diameter <NUM>. The possibility of over-expansion or under-expansion of the valve frame <NUM> is thus reduced. The valve frame <NUM> may be selected based on a measurement (e.g., via an imaging device) of the diameter of the portion of the patient's body to which the frame <NUM> is to be deployed. The valve frame <NUM> may further be selected based on the diameter of expansion of the docking frame <NUM> within the portion of the patient's body, which may be known via a force meter or other mechanical means of determining the diameter of expansion, among other methods.

The valve frame <NUM> may be selected from a set of a plurality of valve frames, which each may be configured to have a different greatest working diameter than each other. For example, a first valve frame in the set may have a greatest working diameter of <NUM> millimeters, a second valve frame in the set may have a greatest working diameter of <NUM> millimeters, and a third valve frame in the set may have a greatest working diameter of <NUM> millimeters. Each valve frame in the set may have a working diameter range of three millimeters for example (e.g., <NUM> millimeters to <NUM> millimeters for the first valve frame, <NUM> millimeters to <NUM> millimeters for the second valve frame, and <NUM> millimeters to <NUM> millimeters for the third valve frame). If the diameter <NUM> is <NUM> millimeters, then second valve frame in the set may accordingly be selected. The greatest working diameters and working diameter ranges may vary according to embodiments herein (e.g., may be greater or lesser as desired), and the working diameter ranges may overlap in embodiments as desired.

The user accordingly may have a set of a plurality of valve frames that may have working diameter ranges less than a certain amount (e.g., three millimeters), and may have working diameter ranges that are narrowly tailored to a specific working diameter. The user (e.g., a medical clinician) may then be able to select a valve frame with a working diameter that fits the diameter <NUM>, and may be optimized to operate at that diameter <NUM>. In certain embodiments, the user may select a valve frame with a narrow working diameter range (e.g., <NUM> millimeter or less) that may exactly fit and be optimized for the diameter <NUM>. A large number of different valve frames may be included in the set of valve frames, however, it is possible that the expense of each valve frame may be less than the expense of an entire prosthetic valve, thus reducing costs associated with storing a large number of different valve frames relative to the cost of storing a large number of full prosthetic valves. As such, the diameter <NUM> may be adapted to, with the selection of the desired valve frame.

Further, the valve frames in the set may be less robust and sturdy than the docking frame <NUM>, and thus may be less expensive to maintain a large store of different sized valve frames. The medical clinician accordingly may keep a variety of different sized valve frames at potentially a reduced expense than keeping a variety of different sized full prosthetic valves for deployment.

The valve frames in the set may each be configured to dock with the docking frame <NUM> to support the respective valve frame within the portion of the patient's body. Each valve frame may further include leaflets configured to operate at the working diameter range of the respective valve frame, and may extend radially inward from an inner surface of the respective valve frame. The docking frame <NUM> as such may be configured to dock with multiple different sizes of valve frames. The relatively large working diameter range of the docking frame <NUM> may allow the docking frame <NUM> to be deployed to a wide variety of diameters within the patient's body, with the valve frame being more closely tailored to the particular diameter within the patient's body.

Referring to <FIG>, the selected valve frame <NUM> may be inserted in a compressed or undeployed configuration into the patient's vasculature. The valve frame <NUM> may be aligned with the docking frame <NUM> to dock with the docking frame <NUM>. The openings <NUM>, for example, of the valve frame <NUM> may be aligned with the docking frame <NUM> and may couple the valve frame <NUM> to the docking frame <NUM>. The docking frame <NUM> may have a length in a deployed or expanded state that is less than the length of the valve frame <NUM> and may be sized to fit into the openings <NUM>. As such, the valve frame <NUM> upon radial expansion may contact the upper edge <NUM> and lower edge <NUM> of the docking frame <NUM> to axially abut the docking frame <NUM> and dock with the docking frame <NUM>. The length of the valve frame <NUM> may reduce to contact against the edges <NUM>, <NUM> of the docking frame <NUM>.

Such a docking is shown, for example, in <FIG>. Such a docking may maintain the valve frame <NUM> in position and configured to resist axial forces of fluid flow applied to the valve frame <NUM>. In other embodiments, other methods of docking may be utilized, such as pins or another form of connector that engages between the docking frame <NUM> and the valve frame <NUM>.

<FIG> illustrates the valve frame <NUM> radially expanded and deployed and docked to the docking frame <NUM> and implanted within the patient's vasculature. The docking frame <NUM> supports the valve frame within the portion of the patient's body, and the valve frame <NUM> supports the leaflets <NUM> within the patient's body. The length of the valve frame <NUM> has reduced along the axis of the valve frame <NUM>, and the diameter of the valve frame <NUM> has expanded to the working diameter <NUM>. The valve leaflets <NUM> may operate within the patient's vasculature and may be utilized in lieu of native leaflets or other leaflets as desired.

The delivery apparatus utilized to deploy the docking frame <NUM> and the valve frame <NUM> may be removed from the patient's body, with the prosthetic valve system remaining implanted in place.

Variations in the systems disclosed herein may be provided.

<FIG>, for example, illustrates an embodiment of a valve frame <NUM> including a plurality of axially extending support arms <NUM>, which may be coupled to a plurality of leaflets <NUM> (three valve leaflets <NUM> are shown in <FIG>). Each support arm <NUM> may couple to the valve leaflets <NUM> at a commissure of the leaflets <NUM>, or in another position as desired. Each support arm <NUM> may extend from a proximal end of the valve frame <NUM> to a distal end of the valve frame <NUM>. Three support arms <NUM> may be provided, circumferentially spaced from each other at the commissures. The support arms <NUM> may be equally spaced from each other circumferentially.

The valve frame <NUM> may include one or more circumferentially extending support arms <NUM> that may couple the axially extending support arms <NUM> to each other. The circumferentially extending support arms <NUM> may extend around the valve leaflets <NUM> at a base or distal portion of the valve leaflets <NUM>, and may extend around the flow channel of the valve frame <NUM>. The circumferentially extending support arms <NUM> may form an outer periphery of the valve frame <NUM>. Openings may be otherwise positioned between the axially extending support arms <NUM>, for instance the proximal ends of the arms <NUM>.

The valve frame <NUM> may have an outer surface and an inner surface and configured to dock to the docking frame <NUM> to support the valve frame within a portion of the patient's body. Three leaflets <NUM> may couple to the valve frame <NUM> and extend radially inward from the inner surface of the support arms <NUM> as shown, or a greater or lesser number of leaflets <NUM> may be utilized as desired.

The valve frame <NUM> may be configured as a wire-form, which may be laser-cut, 3D printed, or formed in another manner. The valve frame <NUM> as such may be a less robust structure than the cylindrical valve frame shown in <FIG>, as material may not extend between the central and proximal portions of the axially extending support arms <NUM>.

The valve frame <NUM> may be configured to be radially collapsed and radially expanded, and may be expanded radially outward from the axis that the valve frame <NUM> surrounds. The valve frame <NUM> may be configured such that a length of the valve frame <NUM> decreases as the width or diameter of the valve frame <NUM> increases, as disclosed herein.

The valve frame <NUM> may include one or more connectors <NUM> that may be positioned on the axially extending support arms <NUM> or another portion of the valve frame <NUM> such as the circumferentially extending support arms <NUM>. The connectors <NUM> may comprise openings as shown in <FIG>, or may have another configuration in another embodiment, such as pins, latches, or other connectors as desired. The connectors <NUM> may be utilized to dock the valve frame <NUM> to a docking frame <NUM> such as the docking frame shown in <FIG>. The docking frame <NUM> may be configured to have connectors <NUM> or the like.

<FIG>, for example, illustrates the docking frame <NUM> coupled to the valve frame <NUM> with connectors <NUM> in the form of pins extending through and engaging the connectors <NUM> of the valve frame <NUM>. The docking frame <NUM> and valve frame <NUM> are shown in partial cross sectional view in <FIG>. The leaflets <NUM> and a third support arm <NUM> are not shown for clarity. The connectors <NUM>, <NUM> may include a proximal connector and a distal connector, and engagement of the connectors <NUM>, <NUM> may be provided at each of the support arms <NUM>.

The valve frame <NUM> and the docking frame <NUM> may be docked together by passing the connectors <NUM> of the docking frame <NUM> through the connectors <NUM> of the valve frame <NUM>. The docking may occur prior to the valve frame <NUM> and docking frame <NUM> being inserted into the patient's body and external to the patient's body.

In such an embodiment, pre-CT or other forms of visualization of the implantation site may occur. A user such as a medical clinician may thus determine the diameter of the portion of the patient's body to which the system will be deployed. The user may then select a desired size of the valve frame <NUM> from a selection of possible sizes of valve frames, in a manner as disclosed herein. For example, the valve frame <NUM> selected may have a working diameter that fits the diameter of the portion of the patient's body to which the system will be deployed, and may be selected from a set of other valve frames having other working diameters, as disclosed herein. The user may then dock the selected valve frame <NUM> to the docking frame <NUM> via the connectors <NUM>, <NUM>. The docked valve frame <NUM> and docking frame <NUM> may then be inserted into the patient's body. The valve frame <NUM> may be deployed and radially expanded along with the docking frame <NUM>, due to the coupling between the valve frame <NUM> and docking frame <NUM>.

In embodiments, the valve frame may be utilized to resist radial compression of the valve frame and docking frame that may be applied to the frames by the portion of the patient's body to which the system is implanted. Such radial compression may result from the radial expansion of the frames, and the resistive force applied by the patient's body to such expansion. In embodiments, the valve frame may be configured to resist axial expansion of the docking frame to provide such a feature. <FIG>, for example, illustrates an embodiment of a valve frame <NUM> configured to be a self-expanding valve frame and configured to expand radially outward. The valve frame <NUM> may be configured to apply a radial force outward due to the biasing of the valve frame. The valve frame <NUM> may be configured similarly as the valve frame <NUM> shown in <FIG> unless otherwise indicated.

The axially extending support arms <NUM>, for example, may form a shaped body <NUM> that is configured to be expanded in length in a compressed or undeployed configuration, and be biased to be reduced in length and expanded in width in a deployed configuration. The shaped body <NUM> for example may surround an opening <NUM> in the support arms <NUM>. The shaped body <NUM> may include wing shaped portions <NUM> that extend circumferentially. The axially extending support arms <NUM> may be coupled to each other with one or more circumferentially extending support arms, as shown in <FIG>, for example. The valve frame <NUM> may be coupled to the docking frame <NUM> via the connectors <NUM>, <NUM> on the valve frame <NUM> and docking frame <NUM> respectively.

Upon the frames being in a compressed state, the frames may be axially expanded and radially compressed. <FIG>, for example, illustrates the valve frame <NUM> and docking frame <NUM> in a compressed configuration with a length being increased from the length shown in <FIG>. The size of the opening <NUM> has expanded in the axial direction. Upon deployment of the frames, the docking frame <NUM> and valve frame <NUM> may move to the expanded configuration shown in <FIG>. The valve frame <NUM> may resist axial expansion of the valve frame <NUM> and the docking frame <NUM> upon being docked to the docking frame <NUM>. The shaped body <NUM>, for instance, may provide an axial force that resists axial expansion of the valve frame <NUM> and docking frame <NUM>. The frames may be resisted from expanding axially by the shaped body <NUM> and thus may be resisted from being radially compressed (as radial compression may require axial expansion). The valve frame <NUM> accordingly may serve to resist radial compression of the frames, and secure the frames within the patient's body.

The valve frame <NUM> may be selected in a similar manner as disclosed herein. For example, a user such as a medical clinician may select a desired size of the valve frame <NUM> from a selection of possible sizes of valve frames, in a manner disclosed herein. For example, the valve frame <NUM> selected may have a working diameter that fits the diameter of the portion of the patient's body to which the system will be deployed, and may be selected from a set of other valve frames having other working diameters, as disclosed herein.

In the embodiments of <FIG>, the valve frames <NUM>, <NUM> may be docked to the docking frame <NUM> prior to insertion into the patient's body. The connectors <NUM>, <NUM> for example, may be engaged between the docking frame <NUM> and the selected valve frame external to the patient's body.

In an embodiment such as shown in <FIG>, the valve frame <NUM> may be coupled to the docking frame <NUM> prior to insertion into the patient's body with only a partial connection of connectors <NUM>, <NUM>.

<FIG> illustrates a side cross sectional view of a portion of the valve frame shown in <FIG> and <FIG> comprising the support arm <NUM>, and the docking frame <NUM> shown in <FIG> and <FIG>. In such a configuration, proximal connectors <NUM>, <NUM> may couple to each other at a proximal end of the valve frame. Such proximal connectors <NUM>, <NUM> may be engaged prior to insertion within the patient's body and external to the patient's body. Distal connectors <NUM>, <NUM>, however, may be unengaged prior to insertion. Upon expansion of the docking frame <NUM>, the valve frame may then expand, causing the connector <NUM> to relatively move axially towards to the connector <NUM> to engage the connector <NUM>. The engagement of the connectors <NUM>, <NUM> may couple the docking frame <NUM> and valve frame to each other. The engagement may further serve as a locking mechanism that resists axial expansion of the docking frame <NUM> and the valve frame. The resistance of the axial expansion accordingly results in a resistance of radial compression of the docking frame <NUM> and the valve frame, as disclosed herein (as radial compression may require axial expansion).

The system according the presently claimed invention utilize connectors that move axially relative to each other to couple the docking frame to the valve frame. Such connectors are utilized in a locking mechanism that may resist an axial expansion of the valve frame and docking frame, and accordingly result in a resistance to radial compression of the valve frame and docking frame. <FIG>, for example, illustrates an embodiment of a valve frame <NUM> having a connector <NUM> in the form of an opening at a proximal portion of the valve frame axial support arm <NUM>. The distal portion of the valve frame axial support arm <NUM> may include distal connectors <NUM>, <NUM> engaged together prior to insertion into the patient's body and external to the patient's body. The valve frame <NUM> may be configured similarly as the valve frame <NUM> shown in <FIG> unless otherwise indicated.

A proximal connector <NUM> in the form of an opening may be configured to receive a proximal connector <NUM> in the form of a pin that is shaped to enter the opening in an axially distal direction and be impeded from exiting the opening in an axially proximal direction. The connector <NUM> is referred to as a first connector on the valve frame <NUM> and the connector <NUM> is referred to as a second connector on the docking frame <NUM>. The first connector <NUM> is configured to relatively move axially towards the second connector <NUM> to engage the second connector <NUM> (and the second connector <NUM> is configured to relatively move axially towards the first connector <NUM> to engage the first connector <NUM>).

<FIG>, for example, illustrates the axial position of the connectors <NUM>, <NUM> prior to engagement. The docking frame <NUM> and the valve frame <NUM> may both be in a compressed state in <FIG>, prior to radial expansion. Due to radial expansion of the valve frame <NUM>, the connector <NUM> moves axially towards to the connector <NUM> such that the connector <NUM> enters and is retained by the connector <NUM>.

Notably, the axial distance <NUM> between the connectors <NUM>, <NUM>, or the length of axial distance travelled by the connector <NUM> relative to the connector <NUM>, may define an amount that the length that the docking frame <NUM> and valve frame <NUM> may be shortened during compression, and accordingly defines a corresponding diameter of outward radial expansion of the valve frame <NUM> and docking frame <NUM> (as radial expansion may require axial shortening). The engagement of the connectors <NUM>, <NUM> may resist further radial expansion of the valve frame <NUM> and the docking frame <NUM> beyond such a diameter.

Further, because the connector <NUM> cannot slide out of the connector <NUM>, the axial distance <NUM> between the connector <NUM> and the connector <NUM> defines a diameter at which radial compression of the valve frame <NUM> and the docking frame <NUM> is resisted by the engagement. The engagement of the connectors <NUM>, <NUM> resists axial expansion and thus resists radial compression of the valve frame and docking frame (as radial compression may require axial expansion). A radially inward force applied to the frames <NUM>, <NUM> shown in <FIG> will not cause an axial expansion of the frames <NUM>, <NUM> because the connector <NUM> is prevented from disengaging with the connector <NUM> axially.

In embodiments, the connector <NUM> may be moved axially proximal to engage the connector <NUM> with a tether of a delivery apparatus or the like. The tether may comprise a portion of the delivery apparatus utilized to deliver the docking frame <NUM> and valve frame <NUM> to the desired implantation site. The tether may be coupled to the valve frame <NUM>. The tether may relatively move the connector <NUM> axially towards the connector <NUM> to engage the connectors <NUM>, <NUM> within the patient's body.

During such an operation, the connectors <NUM>, <NUM> may remain engaged with each other upon axial movement of the connectors <NUM>, <NUM> relative to each other.

In embodiments, the axial distance <NUM> between the connectors <NUM>, <NUM> may be selected based on a desired amount of radial expansion of the valve frame <NUM>. If a greater amount of expansion may be desired, then the connector <NUM> may be positioned further distal on the valve frame <NUM>, and if a lesser amount of expansion is desired, then the connector <NUM> may be positioned further proximal on the valve frame <NUM>. A valve frame <NUM> may be selected from a set of valve frames, each having a different axial position of a connector <NUM>, which may correspond to a desired working diameter of the valve frame <NUM>. The selection of the valve frame may occur from the set of valve frame according to methods disclosed herein.

<FIG>, for example, illustrates an embodiment in which an axial distance <NUM> or length of axial movement of connectors <NUM>, <NUM> may be set based on a length <NUM> of the connector <NUM>. A valve frame <NUM> is shown in <FIG> positioned upon a docking frame <NUM>. A plurality of leaflets <NUM> may be coupled to the valve frame <NUM> (one leaflet <NUM> is represented in <FIG>). The valve frame <NUM> may include connectors <NUM> in the form of arms having latches at their ends that extend axially distal. The arms may extend axially within covers in the form of sleeves <NUM> of the docking frame <NUM>. Upon radial expansion (and axial shortening) of the docking frame <NUM> and valve frame <NUM>, the connectors <NUM> may be relatively moved axially towards the connectors <NUM> on the docking frame <NUM> to engage the connectors <NUM>.

<FIG>, for example, illustrates the docking frame <NUM> and the valve frame <NUM> in a radially expanded state with the connectors <NUM>, <NUM> moved axially towards each other and engaged with each other. The engagement may prevent the valve frame <NUM> and docking frame <NUM> from moving axially away from each other, thus preventing the length of the valve frame <NUM> and docking frame <NUM> from increasing. As such, the diameter of the valve frame <NUM> and docking frame <NUM> is resisted from decreasing, thus locking the valve frame <NUM> and docking frame <NUM> at the desired working diameter. The connectors <NUM>, <NUM> accordingly comprise a locking mechanism that resists axial expansion of the frames <NUM>, <NUM> and resists radial compression of the frames <NUM>, <NUM>.

In embodiments, the length <NUM> of the connector <NUM> may be set according to the selected diameter of expansion for the valve frame <NUM>. As such, the length <NUM> of the arm of the connector <NUM> may define a diameter at which radial compression of the valve frame and docking frame may be resisted by the locking mechanism, and may be tailored based on the desired working diameter of expansion of the valve frame <NUM>. Different valve frames having different diameters may accordingly be utilized with the same docking frame <NUM>, with a resistance to radial compression being defined at a diameter set by the length <NUM> of the connector <NUM>.

The valve frame <NUM> may be selected in a similar manner as disclosed herein. For example, a user (e.g., a medical clinician) may select a desired size of the valve frame <NUM> from a selection of possible sizes of valve frames, as disclosed herein. For example, the valve frame <NUM> selected may have a working diameter that fits the diameter of the portion of the patient's body to which the system will be deployed, and may be selected from a set of other valve frames having other working diameters, as disclosed herein. The length of the connector <NUM> may be configured to correspond to the desired working diameter for the valve frame <NUM>. For example, the plurality of valve frames <NUM> may each have a connector <NUM> (such as an arm) that has a length that differs from each other and defines a diameter at which radial compression of the respective valve frame and the docking frame <NUM> is resisted.

<FIG> illustrates an alternative embodiment in which the connectors <NUM>, <NUM> on the valve frame and docking frame respectively may both be positioned in a cover <NUM> (such as a sleeve) of the valve frame <NUM>. The cover <NUM> may impede the ability of the connectors <NUM>, <NUM> to be snagged or snared or otherwise undesirably contact a portion of the patient's body or the valve system. The length <NUM> of the connector <NUM> may be set to correspond to a desired length <NUM> of axial movement of the connectors <NUM>, <NUM>, as discussed herein.

<FIG> illustrates an embodiment in which a proximal portion of the valve frame <NUM> engages a proximal portion of the docking frame <NUM> via a connector <NUM> on the valve frame <NUM> in the form of an opening that receives a connector <NUM> on the docking frame <NUM> in the form of a pin. The engagement of the connection may be performed exterior to the patient's body, before implantation. The engagement of the connectors <NUM>, <NUM> may occur within the patient's body upon expansion of the frames, as disclosed herein. The length of the connector <NUM> of the valve frame <NUM> may be set to provide a desired axial distance <NUM> or length of axial movement of the connectors <NUM>, <NUM>, as discussed herein.

<FIG> illustrates an embodiment of a valve frame <NUM> in which the support arms <NUM> each include a connector <NUM> configured to axially slide upon a connector <NUM> in the form of a pin extending from a docking frame <NUM>. The connectors <NUM> may comprise openings extending axially and configured to receive the pins. Upon sliding upon the pins, connectors <NUM> in the form of pins may engage connectors <NUM> in the form of openings in the docking frame <NUM>. The valve frame <NUM> may be docked to the docking frame <NUM> by the connection of the connectors <NUM>, <NUM>, <NUM>, <NUM> and the leaflets <NUM> may then operate upon deployment. The docking may occur exterior to the patient's body and prior to implantation as desired. In embodiments, the docking may occur within the patient's body.

Features of the docking frames and valve frames may be combined, substituted, and modified across embodiments.

<FIG> illustrates an embodiment of a delivery apparatus <NUM> that may be utilized according to embodiments herein. The delivery apparatus utilized may be varied in other embodiments. The delivery apparatus <NUM> may include the delivery shaft <NUM>, which may include an implant retention area <NUM> that may retain one or more of the valve frame or docking frame. A sheath of the delivery shaft <NUM> may cover the docking frame or valve frame in the implant retention area <NUM>. The implant retention area <NUM> may be positioned at a distal end <NUM> of the delivery shaft <NUM>. A nosecone <NUM> (as marked in <FIG>) may further be positioned at the distal end <NUM> of the delivery shaft <NUM>. The delivery shaft <NUM> may include a proximal end <NUM> that may couple to a handle <NUM> utilized to grip the delivery apparatus <NUM>, or may couple to another form of housing.

The embodiments as disclosed herein may be discussed in regard to a prosthetic valve, however, the systems, devices, and methods disclosed herein are not limited to prosthetic valves. Other forms of implants and prosthetic implants may utilize the systems, devices, and methods disclosed herein, including stents and other forms of medical implants.

The systems, devices, and methods disclosed herein are not limited to treatment of the aortic valve, but may extend to mitral, pulmonary, and tricuspid valves, as well as treatment of other portions of a patient's body. Other uses may be provided.

The implants may be cylindrical implants, or in other embodiments may have other shapes such as "V" shaped implants or other shapes as desired. The implants may be configured to expand radially outward from an axis that the implant surrounds, for example a longitudinal axis of the implant. The implants may be balloon expandable, mechanically expandable, or may be self-expanding in embodiments, unless otherwise indicated. The delivery apparatuses utilized, for example, may be configured to produce the desired form of expansion. For a balloon expandable valve, for example, the delivery apparatus may include an expansion balloon and may include a lumen for inflating and expanding the balloon positioned interior of the valve. For a mechanically expandable valve, the delivery apparatus may include a mechanical deployment mechanism for expanding the valve. For a self-expanding valve, the delivery apparatus may include a retractable sheath or the like for uncovering the valve and allowing the valve to expand. Other forms of deployment and delivery apparatuses may be utilized as desired.

The connectors as disclosed herein may comprise one or more of a pin, a latch, or an opening, among other forms of connectors.

The systems, devices, and methods disclosed herein may be used in a variety of procedures, which may include transcatheter aortic valve implantation (TAVI). The delivery apparatus and the systems disclosed herein may be utilized for transarterial access, including transfemoral access, to a patient's heart. The approach to the delivery site may be in a variety of manners. For example, an approach to a native aortic valve may be through an aortic arch. In embodiments, a ventricular approach may be utilized, approaching the native aortic valve from the inflow side of the native aortic valve.

In embodiments, the systems, devices, and method disclosed herein may be utilized for mitral, tricuspid, and pulmonary replacement and repair as well. The delivery systems may be utilized in transcatheter percutaneous procedures, including transarterial procedures, which may be transfemoral or transjugular. Transapical procedures, among others, may also be utilized.

The methods herein are not limited to the methods specifically described, and may include methods of utilizing the systems and devices disclosed herein.

The features of the embodiments disclosed herein may be implemented independently of other components disclosed herein. The various apparatuses of the systems may be implemented independently.

In closing, it is to be understood that although aspects of the present specification are highlighted by referring to specific embodiments, one skilled in the art will readily appreciate that these disclosed embodiments are only illustrative of the principles of the subject matter disclosed herein. Therefore, it should be understood that the disclosed subject matter is in no way limited to a particular methodology, protocol, and/or reagent, etc., described herein. Lastly, the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of systems, apparatuses, and methods as disclosed herein, which is defined solely by the claims. Accordingly, the systems, apparatuses, and methods are not limited to that precisely as shown and described.

Certain embodiments of systems, apparatuses, and methods are described herein, including the best mode known to the inventors for carrying out the same. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the systems, apparatuses, and methods to be practiced otherwise than specifically described herein.

Unless otherwise indicated, all numbers expressing a characteristic, item, quantity, parameter, property, term, and so forth used in the present specification and claims are to be understood as being modified in all instances by the term "about. " As used herein, the term "about" means that the characteristic, item, quantity, parameter, property, or term so qualified encompasses an approximation that may vary, yet is capable of performing the desired operation or process discussed herein.

The terms "a," "an," "the" and similar referents used in the context of describing the systems, apparatuses, and methods (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., "such as") provided herein is intended merely to better illuminate the systems, apparatuses, and methods and does not pose a limitation on the scope of the systems, apparatuses, and methods otherwise claimed. No language in the present specification should be construed as indicating any non-claimed element essential to the practice of the systems, apparatuses, and methods.

Claim 1:
A prosthetic valve system comprising:
a docking frame (<NUM>) configured to be implanted within a portion of a patient's body;
a valve frame (<NUM>) having an outer surface (<NUM>) and an inner surface (<NUM>) and configured to dock to the docking frame to support the valve frame within the portion of the patient's body;
a plurality of valve leaflets (<NUM>) coupled to the valve frame and configured to extend radially inward from the inner surface of the valve frame; and
a locking mechanism including a first connector (<NUM>) on the valve frame and a second connector (<NUM>) on the docking frame configured to relatively move axially towards the first connector to engage the first connector;
wherein an axial distance (<NUM>) between the first connector and the second connector defines a diameter (<NUM>) at which radial compression of the valve frame and of the docking frame is resisted by the locking mechanism; and
further comprising a third connector (<NUM>) on the valve frame and a fourth connector (<NUM>) on the docking frame, the third connector and fourth connector configured to remain engaged with each other upon axial movement of the second connector relative to the first connector.