Delivery apparatus for a prosthetic implant

Abstract

A delivery apparatus configured to deliver a prosthetic valve can include a handle, a first shaft and a second shaft extending distally from the handle, and a balloon mounted along a distal end portion of the second shaft, the second shaft extending through a lumen of the first shaft. A distal end of the first shaft has one or more biasing elements, wherein the one or more biasing elements are configured to provide a bias to prevent a gap from forming between the distal end of the first shaft and a proximal end of a medical implant.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 553,088, filed February 13, 2024, which is incorporated herein by reference. Technical Field

[0003] This disclosure relates to delivery devices, systems, and methods for implanting prosthetic implants, such as stents and / or prosthetic heart valves. Background Technology

[0004] The human heart can suffer from a variety of valvular diseases. These valvular diseases can lead to significant dysfunction of the heart and ultimately require repair of the original valve or replacement with an artificial valve. Many known repair devices (e.g., stents) and artificial valves exist, along with many known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various procedures to deliver prosthetic medical devices to locations within the body that are not easily accessible surgically or where access is desired without surgery. In a specific example, a prosthetic heart valve may be mounted in a coiled state on the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral and aortic arteries) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by unfolding the prosthetic heart valve from the sheath of the delivery device, allowing the prosthetic heart valve to self-expand to its functional size. Operating delivery devices for implanting prosthetic heart valves involves complex procedures and requires specialized skills. Therefore, improvements to known transcatheter delivery devices are desired to facilitate their operation. Summary of the Invention

[0005] This document describes devices and methods for delivering prosthetic implants, such as prosthetic heart valves and / or stents, through the body and into an implantation site, such as the heart, for placement therein. Prosthetic implants delivered using the delivery devices disclosed herein (also referred to herein as "delivery systems") are also referred to herein as "prosthetic devices."

[0006] For example, it can expand radially from a radially compressed state mounted on a delivery system to a radially expanded state for implantation using an inflatable balloon (or equivalent expansion device) with the delivery device. Exemplary delivery routes through the body and into the heart include the femoral artery route, the transseptal route, the transapical route, and the transaortic route. While the devices and methods disclosed herein are particularly suitable for implanting prosthetic heart valves (e.g., prosthetic aortic valves, prosthetic mitral valves, prosthetic pulmonary valves, and / or prosthetic tricuspid valves), the disclosed devices and methods may be adapted for implantation in vivo of other types of prosthetic valves (e.g., prosthetic venous valves) or for implantation of other types of expandable prosthetic devices in various body cavities.

[0007] In one of its basic configurations, the delivery device for the prosthetic implant may include a stalk and one or more shafts coupled to the stalk. This basic configuration may preferably be provided with any one or more of the features described elsewhere herein, particularly those features of the examples described below. However, it should be understood that, in addition to or in lieu of the features of the examples described below, the basic configuration may also preferably be provided with any one or more of the features shown in and / or described in conjunction with the accompanying drawings.

[0008] In some examples, the delivery device may include a first shaft extending distally from the handle and a second shaft extending through a cavity of the first shaft.

[0009] In some examples, the delivery device may also include a drawstring extending longitudinally along a first axis. The distal end of the drawstring is fixed relative to the distal end of the first axis. The tension in the drawstring can be adjusted to regulate the curvature of the distal portion of the first axis.

[0010] In some examples, the delivery device may include: a first shaft having a first portion and a second portion, and an inner cavity extending through the first and second portions; a second shaft having a proximal end portion and a distal end portion, the second shaft extending through the inner cavity of the first shaft; and one or more biasing elements coupled to and disposed between the first and second portions of the first shaft, wherein the one or more biasing elements are configured to bias the first portion of the first shaft away from the second portion of the first shaft and toward the distal end portion of the second shaft. In some examples, the one or more biasing elements include a helical compression spring.

[0011] In some examples, the delivery device is part of a component that also includes an expandable medical implant in a radially compressed state, wherein the expandable medical implant is positioned around an expansion device.

[0012] In some examples, one or more biasing elements are compressed between the distal end of the first shaft and the proximal end of the expandable medical implant, such that a first portion of the first shaft applies a force toward the distal end of the proximal end of the expandable implant.

[0013] In some examples, one or more biasing elements are configured to move from a compressed state to an expanded state to hold a first portion of the first axis against the proximal end of the expandable medical implant as it is advanced to the implantation position. In some examples, one or more biasing elements move between a compressed state and an expanded state as the curvature of the first axis changes.

[0014] In some examples, medical implants include prosthetic heart valves, stents, or support structures for prosthetic heart valves.

[0015] In other examples, the distal end of the first axis may also include a biasing element that is adjacent to the proximal end portion of the medical implant and applies an axial forward force to the proximal end of the prosthetic implant mounted on the balloon.

[0016] In some examples, the delivery device is used as part of a method that includes introducing the delivery device into a patient; and adjusting the tension in a drawstring of the delivery device to guide the delivery device through the patient's vascular system, wherein adjusting the tension in the drawstring causes one or more biasing members of the delivery device to expand from a compressed state to an expanded state to maintain contact between the distal end of the first axis and the proximal end of the medical implant.

[0017] The above methods can be performed on live animals or on simulated objects, such as corpses, corpse hearts, anthropomorphic ghosts, and simulators (e.g., with simulated body parts, hearts, tissues, etc.).

[0018] The various innovations disclosed herein can be used in combination or individually. This summary is provided to introduce, in a simplified form, a series of concepts further described in the detailed embodiments below. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of this disclosure will become more apparent from the following detailed description, claims, and drawings. Attached Figure Description

[0019] Figure 1 This is a side view of a delivery device for implanting a prosthetic heart valve, based on an example.

[0020] Figure 2 yes Figure 1A side view of a portion of the handle and a portion of the distal end of the delivery device.

[0021] Figure 3 yes Figure 1 A side view of the delivery device, in which the balloon is not inflated and the spring is not compressed.

[0022] Figure 4 yes Figure 1 A side view of the delivery device, in which the balloon is not inflated and the spring is compressed.

[0023] Figure 5 Depicting Figure 1 The delivery device, according to one example, has a spring in a partially relaxed state to cover the gap between the end portion of the steerable portion and the proximal portion of the implant when the prosthetic valve mounted on the balloon is located within the aortic ring.

[0024] Figures 6 to 7 yes Figure 1 An enlarged cross-sectional view of the distal end portion of the delivery device shows the inflation of the balloon for deployment of a prosthetic heart valve on the balloon.

[0025] Figure 8 A side view of a delivery device with an uninflated balloon and a compressed spring, according to another example, is depicted.

[0026] Figure 9 An example of a prosthetic heart valve that can be implanted using any of the delivery devices disclosed herein is depicted. Detailed Implementation

[0027] General considerations

[0028] It should be understood that the disclosed examples are adaptable to delivering and implanting prosthetic devices into any autologous ring of the heart (e.g., pulmonary ring, mitral annulus, and tricuspid annulus) and can be used with any of a variety of delivery methods (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0029] For the purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, this disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, individually and in various combinations and sub-combinations with each other. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed examples do not require the presence of any one or more particular advantages or problems solved. Techniques from any example can be combined with techniques described in any one or more other examples. Given the many possible examples to which the principles of the disclosed techniques can be applied, it should be recognized that the examples shown are merely preferred examples and should not be considered as limiting the scope of the disclosed techniques.

[0030] While some publicly available examples of operations are described in a specific order for ease of presentation, it should be understood that this description includes rearrangement unless the specific language described below requires a particular order. For example, in some cases, operations described in sequence may be rearranged or performed simultaneously. Furthermore, for the sake of brevity,

[0031] The accompanying drawings may not show the various ways in which the disclosed methods can be used in combination with other methods. Additionally, this specification sometimes uses terms such as "provide" or "implement" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms can vary depending on the specific implementation and are readily discernible to those skilled in the art.

[0032] As used in this application and claims, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” include the plural forms. Additionally, the term “includes” means “comprises.” Furthermore, the terms “link” and “connection” generally refer to an electrical, electromagnetic, and / or physical (e.g., mechanical or chemical) connection or link, and do not exclude the presence of intermediate elements between linked or associated items in the absence of specific contrasting language.

[0033] As used herein, the term "proximal" refers to the location, orientation, or portion of the device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to the location, orientation, or portion of the device that is further away from the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device away from the implantation site and toward the user (e.g., away from the patient's body), while distal movement of the device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to axes extending in the directions of the proximal and distal ends, unless otherwise explicitly defined.

[0034] As described herein, the term "inflow" can generally refer to the location, direction, or portion of the prosthetic heart valve closer to the inlet where blood flows into the prosthetic heart valve. As described herein, the term "outflow" can generally refer to the location, direction, or portion of the prosthetic heart valve closer to the outlet where blood flows out of the prosthetic heart valve.

[0035] Orientation and other relative references (e.g., inside, outside, top, bottom, etc.) may be used to facilitate the discussion of the figures and principles herein, but are not intended to be limiting. For example, certain terms such as “inside,” “outside,” “top,” “bottom,” “internal,” “external,” etc., may be used. When dealing with relative relationships, particularly with respect to the examples shown, such terms are used where applicable to provide some clarity of description. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, for an object, the “upper” portion can simply become the “lower” portion by flipping the object. Nevertheless, it remains the same portion and the object remains unchanged. As used herein, “and / or” means “and” or “or,” as well as “and” and “or.”

[0036] Overview of an exemplary delivery device for implanting prosthetic valves

[0037] In some instances, the delivery device for implanting a prosthetic transcatheter heart valve via a patient's vascular system may include an adjustment mechanism for adjusting the position of a balloon relative to (and / or vice versa) the coiled prosthetic valve. In some examples, the balloon catheter may extend coaxially through a guide (or flexure) catheter, and the balloon at the distal end of the balloon catheter may be positioned proximal or distal to the coiled prosthetic valve. As described in more detail below, the balloon and the coiled prosthetic valve may be inserted into the patient's vascular system through a guide sheath, and once the balloon and the coiled prosthetic valve are in the appropriate position within the body, the prosthetic valve may ultimately expand at the treatment site. The prosthetic valve is advanced to the vicinity of the deployment location (e.g., an autologous aortic valve), and (in certain embodiments) the adjustment mechanism may also be used to precisely adjust or "fine-tune" the position of the prosthetic valve relative to the desired deployment location. Additional information regarding the adjustment mechanism and / or implantation procedure can be found, for example, in U.S. Patent No. 9,339,384 and U.S. Publication No. 2023 / 0210657, which are incorporated herein by reference.

[0038] Figure 1 An example of a suitable device for inserting a prosthetic valve 12 (in) is shown. Figures 6 to 7 The image schematically illustrates a delivery device 10 (e.g., a prosthetic aortic valve) delivered to the heart. Device 10 typically includes a steerable guiding catheter 14 and a balloon catheter 16 extending through the guiding catheter 14. The guiding catheter may also be referred to as a “flexible catheter,” a “leading catheter,” or an “external catheter.” However, the use of the term “leading catheter” should be understood to include flexible or guiding catheters, as well as other catheters that cannot be flexible or guided through the patient’s vascular system. The use of the term “external catheter” does not necessarily mean “outermost”, nor does it exclude one or more additional catheters or axes outside the external catheter; rather, it means that the catheter is radially outward relative to at least one catheter (e.g., a balloon catheter) or axis.

[0039] The illustrative example shows that the guiding catheter 14 and balloon catheter 16 are adapted to slide longitudinally relative to each other to facilitate the delivery and positioning of the prosthetic valve 12 in the patient’s body at the implantation site, as described in detail below.

[0040] The guiding catheter 14 includes a handle portion 20 (or simply "handle") and an elongated guiding tube or guiding catheter shaft 22 extending distally from the handle portion 20. Figure 1A guide catheter shaft 22 extending from the stem portion 20 above the balloon catheter 16 is shown. The balloon catheter 16 includes a proximal portion 24 adjacent to the stem portion 20 and an elongated shaft 26 (also referred to as the "balloon catheter shaft") extending from the proximal portion 24 and through the lumen of the stem portion 20 and the guide catheter shaft 22. In some instances, the stem portion 20 may include a flushing port 27 having an internal channel in fluid communication with the lumen defined by the stem portion 20.

[0041] An inflatable balloon 28 can be mounted at the distal end of the balloon catheter 16 to facilitate the expansion of the prosthesis implant within the patient. A nasal cone 32 can be mounted at the distal end of the delivery device 10 to facilitate the non-invasive advancement of the delivery device 10 through the patient's vascular system to the implantation site.

[0042] In some examples, the balloon catheter may include an inner lumen extending therethrough. In some instances, the lumen may be configured, for example, to receive a guidewire.

[0043] The balloon catheter shaft 26 can be formed from any of a variety of suitable materials, such as nylon, braided stainless steel wire, or polyether block amide (commercially available as Pebax®). The shaft 26 can have longitudinal portions formed from different materials to vary the flexibility of the shaft along its length.

[0044] In some examples, the balloon catheter shaft 26 may include an inner tubular member and an outer braided layer surrounding the tubular member. In some examples, the braid...

[0045] The layer can be composed of braided metal wires (e.g., stainless steel wire, nitinol wire, etc.). In some examples, the braided layer can be formed from metal coils (e.g., stainless steel coils, etc.). The braided layer can have various braid densities along the axis to impart desired flexibility and stiffness to different portions of the axis. In some examples, the metal braided layer can be replaced with a stainless steel thiocyanate tube formed with laser-cut and circumferentially extending openings. Additional examples of braided layers are described in U.S. Patent No. 8,568,472, the entire contents of which are incorporated herein by reference.

[0046] The guide catheter shaft 22 includes a steerable distal end portion 68 (also referred to as the "steerable portion") Figure 2The curvature of the stem 20 can be adjusted by the operator to help guide the delivery device 10 through the patient's vascular system, particularly the aortic arch. The exemplified example's stem 20 includes a distal stem portion 46 and a proximal stem portion 48. The distal stem portion 46 is configured as an actuating mechanism for adjusting the curvature of the steerable portion 68 of the guide catheter shaft 22, and as a deflection indicator 51 allowing the operator to measure the relative amount of deflection of the steerable portion 68 of the guide catheter shaft 22. The distal stem portion 46 can be operatively connected to the steerable portion 68 and serves as an adjustment mechanism to allow the operator to adjust the curvature of the steerable portion 68 by manually adjusting the deflection activation member 50 on the distal stem portion 46. Additionally, the deflection indicator 51 can provide visual and tactile responses at the stem 20, providing the operator with an immediate and direct way to determine the amount of deflection of the steerable portion 68 of the guide catheter shaft 22.

[0047] In some examples, the steerable portion 68 is slightly curved in its non-deflected shape, and in its fully curved position, the steerable portion 68 generally conforms to the shape of the aortic arch. In some examples, the steerable portion 68 may be substantially straight in its non-deflected position.

[0048] The distal stem portion 46 may have other configurations suitable for adjusting the curvature of the steerable portion 68. One such alternative stem configuration is shown in U.S. Patent No. 7,780,723, the entire contents of which are incorporated herein by reference. Further details relating to the steerable portion and stem configuration discussed above can be found in U.S. Patent No. 8,568,472, the entire contents of which are incorporated herein by reference.

[0049] The deflection indicator 51 may include visual markings on the outer surface of the body 54 of the distal shank portion 46, such as visual markings indicating the amount of deflection of the steerable portion 68 based on the position of the indicator pin 52 relative to the visual markings. Such markings may identify the amount of deflection in any of a variety of ways. For example, the outer surface of the body 54 may include a series of numbers (e.g., 0 to 10) adjacent to the slot, which indicates the amount of curvature of the steerable portion 68 based on the position of the indicator pin 52 relative to the numerical scale.

[0050] In some examples, the fixation mechanism 98 is operable to restrict movement of the balloon catheter shaft 26 (in both the axial and rotational directions) relative to the proximal stem portion 48. Further, the fixation mechanism 98 is movable between a proximal position and a distal position closer to the adjacent end of the knob 84. In the proximal position, the fixation mechanism applies a small force (if any) to the balloon catheter shaft 26, which can slide freely relative to the entire stem 20 and the guide catheter shaft 22. As the fixation mechanism 98 rotates to move to its distal position closer to the knob 84, the fixation mechanism 98 locks the balloon catheter shaft 26 relative to the distal stem portion 46. In the locked position, rotation of the adjusting knob 84 causes axial movement of the balloon catheter shaft 26 relative to the guide catheter shaft 22 (in either the proximal or distal direction, depending on the direction of rotation of the knob 84).

[0051] If the fixation mechanism 98 is not engaged to hold the balloon catheter shaft 26, the balloon catheter shaft 26 can be moved proximally by simply sliding / pulling it. For more precise control of the balloon catheter shaft 26, the fixation mechanism 98 can be engaged to hold the balloon catheter shaft 26, in which case the adjustment knob 84 is rotated to move the balloon catheter shaft 26 and the balloon 28.

[0052] As the prosthetic valve 12 moves closer to its deployment location within the aortic annulus, controlling the precise position of the prosthetic valve 12 by pushing or pulling the stem portion 20 becomes increasingly difficult due to the curved portion of the delivery device. When pushing or pulling the stem portion 20, slack is removed from the curved portion of the delivery device before the push / pull force is transmitted to the distal end of the delivery device. To more accurately position the prosthetic valve 12 within the aortic annulus, the prosthetic valve 12 is positioned as close as possible to its final deployment location (e.g., within the aortic annulus, such that the inflow portion of the prosthetic valve 12 is in the left ventricle and the outflow portion of the prosthetic valve 12 is in the aorta) by pushing / pulling the stem portion 20, and the final positioning of the prosthetic valve 12 is completed using the adjustment knob 84. To use the adjustment knob 84, the fixation mechanism 98 is placed in its locked position as described above. Then, with the handle 20 held stable (which guides the catheter shaft 22 in place), the adjusting knob 84 is rotated to move the balloon catheter shaft 26 in a distal or proximal direction, and thus move the prosthetic valve 12. For example, rotating the knob in a first direction (e.g., clockwise) moves the prosthetic valve 12 proximally into the aorta, while rotating the knob in a second opposite direction (e.g., counterclockwise) advances the prosthetic valve 12 distally toward the left ventricle. Advantageously, the operation of the adjusting knob 84 is effective for moving the prosthetic valve 12 in a precise and controlled manner, without the sudden, abrupt movements that can occur when pushing or pulling the delivery device 10 for final positioning.

[0053] Additional features of the delivery device and some variations of the delivery device are described in U.S. Patent No. 9,339,384 and U.S. Publication No. 2023 / 0210657.

[0054] As described above, in order to implant a prosthetic valve (e.g., prosthetic valve 12) into a patient's natural heart valve, the delivery device 10 can be introduced into the patient's vascular system. As the prosthetic valve 12 is guided through the aortic arch and into the ascending aorta, the curvature of the steerable portion 68 can be adjusted to help guide or steer the prosthetic valve 12 through that portion of the vascular system. Reference Figure 3 The steerable portion 68 of the guide catheter shaft 22 includes a pull wire 78, the distal end 78d of which is located at the distal end 68d of the steerable portion 68. When the navigation prosthetic valve 12 passes through the arcuate region of the vascular system (e.g., the aortic arch), the curvature of the steerable portion 68 can be adjusted, for example, by rotating the adjustment knob 56 to tension the pull wire 78.

[0055] In some instances, flexing the steerable portion 68 of the guide catheter shaft 22 to adjust curvature can result in shortening of the guide catheter shaft relative to the balloon catheter shaft 26. Shaft 22 includes features to compensate for shortening. These features can, for example, prevent or reduce the likelihood of a gap forming between the distal end of the guide catheter shaft 22 and the proximal end of the prosthetic valve 12. Maintaining the distal end of the guide catheter 22 abutting the proximal end of the prosthetic valve can provide one or more advantages. For example, proximal movement of the valve relative to the balloon can be prevented. Additionally (or alternatively), a relatively smooth transition from the prosthetic valve to the guide catheter shaft can be provided, allowing the prosthetic valve to traverse the patient's vascular system with minimal friction.

[0056] like Figure 1 As shown, the distal end portion of the guide catheter shaft 22 may include one or more biasing elements (also referred to as biasing members). Figure 3 As shown, in some examples, one or more biasing elements may be deposited between two segments of the guide catheter shaft 22. A first segment 42 of the shaft 22 may be coupled to the distal end of one or more biasing elements, and a second segment 44 of the shaft 22 may be coupled to the proximal end of the biasing element and extend to the stem portion 20. In some examples, the proximal end of the biasing element is coupled to the distal end 68d of the steerable portion 68. Both the first segment 42 and the second segment 44 are part of the guide catheter shaft 22 and may have the same shape and material. The first segment 42 of the shaft 22 is deposited between the biasing element and the prosthetic valve 12 and can be used to create a better fit between the distal end of the spring 40 and the proximal end of the prosthetic valve 12.

[0057] In the illustrated example, one or more biasing elements are helical compression springs 40. Spring 40 is disposed between the distal end 68d of the steerable portion 68 and the proximal end of the first portion 42 of the guide tube shaft 22, and is coaxial with the guide tube shaft 22. In some examples, the spring 40 may comprise stainless steel, nitinol, and / or other materials with similar elastic properties. In some examples, multiple compression springs may be used. The various springs may include the same or different spring stiffnesses. In some examples, one or more biasing elements may comprise a volute spring or another type of elastic device biased to an axially expanding configuration and movable to an axially compressed state. In some examples, one or more compression springs and / or one or more other biasing members (e.g., one or more compression springs and / or one or more volute springs) may be used.

[0058] In some instances, such as Figures 1 to 7 As shown, the biasing element (such as spring 40) is exposed and not enclosed. This can have the advantage of simplifying equipment preparation, as it allows the operator to observe spring compression when tension is applied during equipment preparation, which will be discussed in detail below.

[0059] In other instances, such as Figure 8 As depicted, the biasing element (such as spring 40) may be overmolded, surrounded by a sheath / sleeve 222, or otherwise encased in material in a manner that does not significantly restrict the expansion or contraction of the biasing element. This can be achieved by using a material that is softer and / or more elastic than the material of the guide catheter shaft 22. In some examples, the guide catheter shaft 22 has a first indicated stiffness, and the sheath has a second indicated stiffness, wherein the first indicated stiffness is greater than the second indicated stiffness. The sleeve 222 may have the advantage of reducing friction between the biasing element and the patient's vascular system. Figure 8 The overmolding described herein can also be applied to any of the examples in this article, including Figures 1 to 7 The example depicted in the text.

[0060] Figure 3 The delivery device is depicted with the spring 40 in an uncompressed state, and Figure 4 A delivery device with spring 40 in a compressed state is depicted. Spring 40 is compressed by applying a proximal axial force to balloon catheter 26. This force causes balloon catheter 26 (as well as balloon 28 and prosthetic valve 12) to move proximally relative to guide tube axis 22, thereby causing spring 40 to move from an uncompressed state to a compressed state. Spring 40 (and / or any other biasing element) can be compressed and / or expanded before the delivery device is inserted into the patient. Additionally (or alternatively), biasing elements can be compressed and / or expanded when the delivery device is positioned within the patient's vascular system.

[0061] As an example, the spring 40 can be compressed during device preparation before the delivery device 10 is introduced into the patient's vascular system. Before the delivery device 10 is introduced, the coiled prosthetic valve 12 can be moved relative to the balloon (or vice versa) to position the coiled prosthetic valve 12 on the balloon 28. The balloon catheter shaft and the guide catheter shaft can then be moved relative to each other so that the spring 40 is compressed between the distal end of the second segment 44 of the shaft 22 and the proximal end of the first segment 42. As discussed above, the proximal stem portion 48 serves as an adjustment device for moving the balloon 28 proximally into position within the frame of the prosthetic valve 12.

[0062] In some examples, the delivery device may include one or more markings located on the proximal end portion of the balloon catheter 26 adjacent to the handle 20, which may assist the operator by indicating the magnitude of tension applied to the balloon catheter shaft 26. These markings help the operator determine the appropriate tension to be applied, such as during device preparation in the background prior to insertion. The markings may provide one or more advantages. For example, one advantage of the markings is that, due to the long working length of the delivery device catheter, the operator can quickly and easily determine when the spring 40 is correctly compressed by observing the markings adjacent to the handle, without needing to visually inspect the spring 40 at the distal end portion of the delivery device. Another example advantage of the markings is that when the end of the delivery device is not visible (or may be less visible), such as when the device is inserted into the body and / or under fluoroscopy, the operator can manipulate the compression of the spring 40 and have a visual indication of the spring's state.

[0063] exist Figure 4 In the example shown, the delivery device includes a single mark 58 positioned on the balloon catheter shaft 26 to indicate the correct tension. When the delivery device is... Figure 3 The uncompressed state described in the text is manipulated to Figure 4 In the compressed state depicted, the balloon catheter shaft 26 moves axially proximally relative to the guide catheter 22 and the stem 20. This relative movement results in... Figure 3 Mark 58, which is obscured by the handle. Figure 4 The mark becomes visible. This single mark provides an indication of when the spring has been compressed to the desired state. This can, for example, prevent over-compression of the biasing element. It also prevents excessive axially forward force from being applied to valve 12, which could otherwise cause valve 12 to move relative to the balloon.

[0064] In other examples, one or more markings may be a series of markings, such as lines, numbers, visual representations of the spring, and / or other symbols. In one example, the markings may indicate the tension range on the balloon shaft and / or the compression range of the spring, such as a first tension / compression amount, a second tension / compression amount, and a third tension / compression amount. In some examples, no marking may be shown when the spring is not compressed, one marking may be shown when the spring is partially compressed, and two markings may be shown when the spring is fully compressed.

[0065] refer to Figure 5 As the prosthetic valve 12 is guided through the aortic arch and into the ascending aorta, the curvature of the steerable portion 68 can be adjusted (as explained in detail above) to help guide or steer the prosthetic valve 12 through this portion of the vascular system. This curvature of the steerable portion 68 results in a shortening of the distal end 68d. This shortening results in an increased distance between the distal end 68d and the proximal end of the prosthetic valve 12. When the steerable portion 68 retracts, some compression in the spring 40 relaxes, and the length of the spring 40 expands to cover the gap. This expansion of the spring helps maintain contact between the distal end of the first segment 42 of the shaft 22 and the proximal end of the prosthetic valve 12 when the prosthetic valve 12 mounted on the balloon 28 is manipulated around the aortic arch and substantially coaxially aligned within the aortic valve annulus 30.

[0066] like Figures 6 to 7 As shown, the nasal cone 32 has a tapered shape to facilitate non-invasive passage through the patient's vascular system. For example, the nasal cone 32 may taper radially inward from its proximal end portion 32p to its distal end portion 32d (also referred to as the "distal tip"). The nasal cone 32 may connect to a shoulder 126 within the balloon 28 to aid in the positioning of the prosthetic valve 12. The shoulder 126 advantageously includes a tapering member 125 having its maximum diameter at its proximal end adjacent to the distal end portion 12d of the prosthetic valve 12. Figure 6 ), and gradually narrows toward the nasal cone 32 in the distal direction.

[0067] As the prosthetic valve 12 is pushed through the calcified autologous leaflet by shielding the distal end 12d of the prosthetic valve 12 from contact with the autologous leaflet, the shoulder portion 126 serves as a transition between the nasal cone 32 and the prosthetic valve 12. In some examples, the nasal cone 32 and the shoulder portion 126 may be constructed as a single unit, also referred to as a nasal cone assembly.

[0068] When the prosthetic valve 12 is in the deployment position, it expands to contact the natural valve annulus. The expanded prosthetic valve is anchored within the autogenous aortic valve annulus by the radial outward force of the valve frame on the surrounding tissue. Figure 6As shown, before balloon inflation, the guide catheter shaft 22 (including the first segment 42, spring 40, and second segment 44) is withdrawn from balloon 28. Balloon 28 is then inflated, which causes radial dilation of the prosthetic valve 12.

[0069] Figure 8 The distal end portion of a delivery device 200 according to another example is shown. In some examples, the delivery device 200 is identical to the delivery device 10, except for the differences described below. For example, the delivery device 200 may include a stem portion 20, a balloon catheter shaft 26, a flexure activation member 50, a drawwire 78, etc., and for the sake of brevity, these components will not be repeated here. In some examples, the delivery device 200 may include a distal end portion of a guide catheter shaft 220, which may include one or more biasing elements (also referred to as biasing members). In the illustrated example, the biasing element is a coil spring 240 coupled to the distal end of the guide catheter shaft 220. When used in combination with a prosthetic valve 12, the distal end of the coil spring 240 abuts the proximal end of the prosthetic valve 12.

[0070] Figure 9 A prosthetic heart valve 400 is shown, which can be a specific example of the prosthetic valve 12 described above. As shown, the heart valve 400 includes a frame or stent 402 and a leaflet structure 404 supported by the frame. In some examples, the prosthetic heart valve 400 is adapted for implantation in an autologous aortic valve and can be implanted using, for example, the delivery device 10 described above. The prosthetic valve 400 can also be implanted using any other delivery device described herein.

[0071] In some examples, frame 402 comprises a plastically expandable material, which may be a metal alloy, a polymer, or a combination thereof. Example metal alloys may include one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some examples, frame 402 may comprise stainless steel. In some examples, frame 402 may comprise cobalt-chromium. In some examples, frame 402 may comprise nickel-cobalt-chromium. In some examples, frame 402 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (trade name of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35 wt% nickel, 35 wt% cobalt, 20 wt% chromium, and 10 wt% molybdenum.

[0072] In some examples, the prosthetic valve 12 or 400 may be a self-expanding prosthetic valve with a frame made of a self-expanding material such as nitinol. When the prosthetic valve is a self-expanding valve, the balloon of the delivery device may be replaced with a sheath or similar restraint device that holds the prosthetic valve in a radially compressed state for delivery through the body. When the prosthetic valve is in the implantation position, it can be released from the sheath and thus allowed to expand to its functional size. It should be noted that any delivery device disclosed herein may be adapted for use with a self-expanding valve.

[0073] sterilization

[0074] Any of the systems, devices, equipment, etc., described herein may be sterilized (e.g., by heating / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure their safety for patient use, and any method described herein may include sterilization of the associated systems, devices, equipment, etc., as a step in the process. Examples of heating / heat sterilization include steam sterilization and autoclaving. Examples of radiation used for sterilization include, but are not limited to, gamma radiation, ultraviolet radiation, and electron beams. Examples of chemicals used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. For example, sterilization with hydrogen peroxide may be performed using hydrogen peroxide plasma.

[0075] Delivery technology

[0076] To implant a prosthetic valve into the autogenous aortic valve via a femoral artery delivery method, the prosthetic valve is mounted along the distal portion of the delivery device in a radially compressed state. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the autogenous aortic valve and radially dilated (e.g., by inflating a balloon, actuating one or more actuators of the delivery device, or deploying the prosthetic valve from the sheath to allow for self-dilation). Alternatively, the prosthetic valve can be implanted into the autogenous aortic valve during a transapical procedure, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through surgical openings in the chest and at the apex of the heart, and the prosthetic valve is positioned within the autogenous aortic valve. Alternatively, in transaortic surgery, a prosthetic valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or a right parasternal thoracotomy, and then advanced through the ascending aorta toward the autologous aortic valve.

[0077] To implant a prosthetic valve into an autologous mitral valve via transseptal delivery, the prosthetic valve is mounted radially compressed along the distal portion of the delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced through the inferior vena cava into the right atrium, through a perforation created in the atrioventricular septum, into the left atrium, and advanced toward the autologous mitral valve. Alternatively, the prosthetic valve can be implanted into the autologous mitral valve via a transapical procedure, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex, and positioned within the autologous mitral valve.

[0078] To implant a prosthetic valve into an autologous tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal portion of the delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into the inferior vena cava, passing through the inferior vena cava into the right atrium, with the prosthetic valve positioned within the autologous tricuspid valve. A similar method can be used to implant a prosthetic valve into the natural pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the natural tricuspid valve into the right ventricle and towards the pulmonary valve / pulmonary artery.

[0079] Another delivery method is the transatrial approach, whereby the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the atrial wall (in the right or left atrium) to access any autologous heart valve. Atrial delivery can also be performed intravascularly, such as from the pulmonary vein. Yet another delivery method is the transventricular approach, whereby the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the wall of the right ventricle (usually at or near the base of the heart) to implant the prosthetic valve into an autologous tricuspid valve, autologous pulmonary valve, or pulmonary artery.

[0080] In all delivery methods, the delivery device can be advanced over a guidewire previously inserted into the patient's vascular system. Furthermore, the disclosed delivery methods are not intended to be limiting. Any prosthetic valve disclosed herein can be implanted using any of the various delivery procedures and devices known in the art.

[0081] The treatment techniques, methods, procedures, etc. described or proposed in this article or cited in the references hereinceum may be performed on live animals or on non-living simulants, such as on cadavers, cadaver hearts, anthropomorphic dummy targets, simulants (e.g., those with simulated body parts, tissues, etc.).

[0082] Other examples of the disclosed technology

[0083] In view of the embodiments described above for the disclosed subject matter, this application discloses further examples listed below. It should be noted that a feature or combination of features of a single example, or more than one feature of an example, and optionally combined with one or more features of one or more other examples, are also further examples falling within the scope of this application's disclosure.

[0084] Example 1. A delivery device for delivering a medical implant to an implantation site in a patient, the delivery device comprising: a first shaft having a first portion and a second portion, and an inner cavity extending through the first portion and the second portion; a second shaft having a proximal end portion and a distal end portion, the second shaft extending through the inner cavity of the first shaft; and one or more biasing elements coupled to and disposed between the first portion and the second portion of the first shaft, wherein the one or more biasing elements are configured to bias the first portion of the first shaft away from the second portion of the first shaft and toward the distal end portion of the second shaft.

[0085] Example 2. The delivery device as described in any of the embodiments herein, particularly Example 1, further includes a drawwire extending longitudinally along the first axis, wherein the distal end of the drawwire is fixed relative to the first axis, and wherein the tension in the drawwire can be adjusted to adjust the curvature of the distal end portion of the first axis.

[0086] Example 3. The delivery device as described in any of the embodiments herein, particularly Example 1 or Example 2, further includes an expansion member coupled to the distal end portion of the second shaft.

[0087] Example 4. The delivery device as described in any of the embodiments herein, particularly Example 3, wherein the expansion member is an inflatable balloon.

[0088] Example 5. A delivery device as described in any of the embodiments herein, particularly any one of Examples 1 to 4, wherein the one or more biasing elements comprise a helical compression spring.

[0089] Example 6. An assembly comprising any of the embodiments herein, particularly any one of Examples 3 to 5, and further comprising an expandable medical implant in a radially compressed state, wherein the expandable medical implant is disposed around the distal end portion of the second axis.

[0090] Example 7. The assembly as described in any of the embodiments herein, particularly Example 6, wherein one or more biasing elements are compressed between the distal end of the first shaft and the proximal end of the expandable medical implant, such that the first portion of the first shaft applies a distally directed force to the proximal end of the expandable implant.

[0091] Example 8. The component as described in any of the embodiments herein, particularly Example 7, wherein one or more biasing elements are configured to move from a compressed state to an expanded state to retain the first portion of the first axis against the proximal end of the expandable medical implant when the expandable medical implant is advanced to the implantation position.

[0092] Example 9. The component as described in any of the embodiments herein, particularly Example 8, wherein the one or more biasing elements move between the compressed state and the expanded state when the curvature of the first axis changes.

[0093] Example 10. The component as described in any of the embodiments herein, particularly any one of Examples 6 to 9, wherein the medical implant includes a prosthetic heart valve, a stent, or a support structure for a prosthetic heart valve.

[0094] Example 11. An assembly for delivering a medical implant to an implantation site, the assembly comprising: a delivery device including: an inner catheter shaft having a proximal end portion and a distal end portion; an expandable balloon disposed on the distal end portion of the inner catheter shaft; an outer catheter shaft having a first portion extending proximally from the distal end of the outer shaft and a second portion disposed proximally relative to the first portion; one or more biasing members coupled to the first portion and the second portion of the outer shaft; and an expandable implant disposed around the expandable balloon, the expandable implant having a proximal end portion and a distal end portion, wherein the one or more biasing members are movable between a compressed state and an expanded state, wherein in the compressed state and the expanded state, the one or more biasing members push the distal end of the outer shaft against the proximal end of the expandable implant.

[0095] Example 12. The assembly as described in any of the embodiments herein, particularly Example 11, wherein one or more biasing members comprise a helical compression spring.

[0096] Example 13. The component as described in any of the embodiments herein, particularly any one of Examples 11 to 12, further includes a drawwire extending longitudinally along the second portion of the external conduit shaft, wherein the distal end of the drawwire is fixed relative to the second portion, and wherein the tension in the drawwire can be adjusted to adjust the curvature of the distal end portion of the second portion of the external conduit shaft.

[0097] Example 14. The component as described in any of the embodiments herein, particularly any one of Examples 11 to 13, wherein the medical implant comprises a prosthetic heart valve.

[0098] Example 15. The component as described in any of the embodiments herein, particularly Example 14, wherein the prosthetic heart valve includes an annular frame and a plurality of leaflets coupled to and disposed within the frame.

[0099] Example 16. A delivery device or component as described in any of the embodiments herein, particularly any one of Examples 1 to 15, wherein the delivery device or system is sterilized.

[0100] Example 17. A method of implanting a medical implant, the method comprising: introducing a delivery device into a patient; and adjusting tension in a drawstring of the delivery device to guide the delivery device through the patient's vascular system, wherein adjusting the tension in the drawstring causes one or more biasing members of the delivery device to expand from a compressed state to an expanded state to maintain contact between a distal end of a first axis and a proximal end of the medical implant.

[0101] Example 18. The method as described in any of the embodiments herein, particularly Example 17, further includes advancing the distal end portion of the delivery device toward the implantation site until the medical implant is in or near the desired implantation site.

[0102] Example 19. The method as described in any of the embodiments herein, particularly Example 17 or Example 18, further includes inflating a balloon, wherein inflating the balloon causes radial expansion of the medical implant.

[0103] Example 20. The method as described in any of the embodiments herein, particularly any one of Examples 17 to 19, wherein prior to introducing the delivery device into the patient, the method further includes moving the one or more biasing members from the expanded state to the compressed state by moving the first axis of the delivery device relative to the second axis of the delivery device.

[0104] Example 21. The method as described in any of the embodiments herein, particularly any one of Examples 17 to 20, wherein the medical implant is a prosthetic heart valve, and the method further includes advancing the distal end portion of the delivery device through the patient's aorta until the medical implant is in or near the patient's autologous aortic valve.

[0105] Example 22. The method as described in any of the embodiments herein, particularly any one of Examples 17 to 21, wherein the steps are performed on a live animal or a simulant.

[0106] Example 23. A delivery device for delivering a medical implant to an implantation site in a patient, the delivery device comprising: a shaft having a proximal end portion and a distal end portion; and a biasing element coupled to the distal end portion and coaxial with the shaft.

[0107] Unless otherwise stated, the features described in any example herein may be combined with other features described in any one or more of the other examples. For example, any one or more features of a locking mechanism may be combined with any one or more features of another locking mechanism. As another example, any one or more features of a delivery device may be combined with any one or more features of another delivery device.

[0108] Given the many possible ways in which the principles of this disclosure can be applied, it should be recognized that the illustrated constructions depict examples of the disclosed technology and should not be construed as limiting the scope of this disclosure or the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A delivery device for delivering a medical implant to an implantation site within a patient, the delivery device comprising: A first shaft having a first portion and a second portion and an inner cavity extending through the first portion and the second portion; A second shaft having a proximal end portion and a distal end portion, the second shaft extending through the cavity of the first shaft; and One or more biasing elements are coupled to and disposed between the first portion and the second portion of the first shaft, wherein the one or more biasing elements are configured to bias the first portion of the first shaft away from the second portion of the first shaft and toward the distal end portion of the second shaft.

2. The delivery device of claim 1, further comprising a drawwire extending longitudinally along the first axis, wherein a distal end of the drawwire is fixed relative to the first axis, and wherein tension in the drawwire can be adjusted to adjust the curvature of the distal end portion of the first axis.

3. The delivery device as claimed in any one of claims 1 to 2, the delivery device further comprising an expansion member coupled to the distal end portion of the second shaft.

4. The delivery device of claim 3, wherein the expansion member is an inflatable balloon.

5. The delivery device according to any one of claims 1 to 4, wherein the one or more biasing elements comprise a helical compression spring.

6. An assembly comprising a delivery device according to any one of claims 3 to 5, and further comprising an expandable medical implant in a radially compressed state, wherein the expandable medical implant is disposed around the distal end portion of the second axis.

7. The assembly of claim 6, wherein the one or more biasing elements are compressed between the distal end of the first shaft and the proximal end of the expandable medical implant, such that the first portion of the first shaft applies a distally directed force to the proximal end of the expandable implant.

8. The component of claim 7, wherein the one or more biasing elements are configured to move from a compressed state to an expanded state to retain the first portion of the first axis against the proximal end of the expandable medical implant when the expandable medical implant is advanced to the implantation position.

9. The component of claim 8, wherein the one or more biasing elements move between the compressed state and the expanded state when the curvature of the first axis changes.

10. The component of any one of claims 6 to 9, wherein the medical implant comprises a prosthetic heart valve, a stent, or a support structure for a prosthetic heart valve.

11. A component for delivering a medical implant to an implantation site, the component comprising: Delivery device, the delivery device comprising: An internal catheter shaft having a proximal end portion and a distal end portion; An expandable balloon is disposed on the distal end portion of the internal catheter shaft; An external conduit shaft having a first portion extending proximally from a distal end of the external shaft and a second portion disposed proximally relative to the first portion; One or more biasing members, said one or more biasing members being coupled to the first portion and the second portion of the outer shaft; and An expandable implant disposed around the expandable balloon, the expandable implant having a proximal end portion and a distal end portion. The one or more biasing members are movable between a compressed state and an expanded state, wherein in the compressed state and the expanded state, the one or more biasing members push the distal end of the outer shaft against the proximal end of the expandable implant.

12. The assembly of claim 11, wherein the one or more biasing members comprise a helical compression spring.

13. The component of any one of claims 11 to 12, the component further comprising a drawwire extending longitudinally along the second portion of the external conduit shaft, wherein a distal end of the drawwire is fixed relative to the second portion, and wherein tension in the drawwire can be adjusted to adjust the curvature of the distal end portion of the second portion of the external conduit shaft.

14. The component of any one of claims 11 to 13, wherein the medical implant comprises a prosthetic heart valve.

15. The component of claim 14, wherein the prosthetic heart valve includes an annular frame and a plurality of leaflets coupled to and disposed within the frame.

16. A method of implanting a medical implant, the method comprising: Introduce the delivery device into the patient; as well as Adjusting the tension in the drawstring of the delivery device to guide the delivery device through the patient's vascular system, wherein adjusting the tension in the drawstring causes one or more biasing members of the delivery device to expand from a compressed state to an expanded state to maintain contact between the distal end of the first axis and the proximal end of the medical implant.

17. The method of claim 16, further comprising advancing a distal end portion of the delivery device toward the implantation site until the medical implant is in or near the desired implantation site.

18. The method of any one of claims 16 to 17, further comprising inflating a balloon, wherein inflating the balloon causes radial expansion of the medical implant.

19. The method of any one of claims 16 to 18, wherein before introducing the delivery device into the patient, the method further comprises: The one or more biasing members are moved from the expanded state to the compressed state by moving the first axis of the delivery device relative to the second axis of the delivery device.

20. The method of any one of claims 16 to 19, wherein the medical implant is a prosthetic heart valve, and the method further comprises advancing the distal end portion of the delivery device through the patient's aorta until the medical implant is in or near the patient's autologous aortic valve.

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