Commissural alignment balloon for transcatheter procedures

Abstract

A balloon catheter system for delivering an artificial heart valve to a target site in a patient's natural valve includes a delivery shaft and a balloon fixedly attached to the delivery shaft. When the balloon is deflated, the balloon's membrane material defines several folded portions extending along the longitudinal axis of the delivery shaft. The balloon catheter system also includes an artificial heart valve positioned on the balloon when the balloon is deflated and the artificial heart valve is folded, wherein a first set of folded portions extends clockwise around the longitudinal axis of the delivery shaft, and a second set of folded portions extends counterclockwise around the longitudinal axis of the delivery shaft.

Description

Technical Field

[0001] This specification relates to a delivery system for a medical device and a method of using the same. For example, this specification relates to a delivery system for an implantable medical device, such as an artificial heart valve, that can be delivered minimally invasively using a balloon catheter.

Background Art

[0002] Some artificial heart valves can be delivered in a minimally invasive manner to avoid open heart surgery. Such artificial heart valves can be delivered using a catheter system that is operated by a clinician using an actuator handle and / or other types of control mechanisms that remain external to the patient. For example, in some such examples, the artificial heart valve and balloon are compressed within a balloon catheter, and the balloon catheter can be expanded using one or more controls on an actuator handle.

[0003] A transcatheter aortic valve replacement (TAVR) delivery system can be used to deliver an artificial aortic valve to the site of a native aortic heart valve. Clinicians may encounter difficulties when delivering an artificial aortic valve minimally invasively using such a catheter-based delivery system. One such difficult area relates to the task of aligning the artificial heart valve with the patient's native valve.

Summary of the Invention

[0004] This specification describes delivery systems for medical devices and methods of use thereof. For example, this specification describes delivery systems for implantable medical devices, such as artificial heart valves, that can be delivered minimally invasively using a catheter system. In some embodiments, the delivery system includes an artificial heart valve positioned in a balloon catheter. The balloon catheter can be advanced intravascularly to a patient's target treatment site, such as the innate heart valve region (e.g., the aortic valve or other innate heart valve), while under visualization from one or more imaging devices (e.g., computed tomography (CT) imaging device, X-ray fluoroscopy system, etc.). This allows the clinician to navigate the balloon catheter to the target treatment site and deploy the artificial heart valve with the desired alignment and anatomical features of the innate heart valve.

[0005] To deploy the artificial heart valve, the balloon of the balloon catheter may be inflated, thereby transitioning the artificial heart valve from a thin, radially folded state to an expanded state in which the artificial heart valve is operational. In some embodiments, before the balloon is inflated, the artificial heart valve is positioned by a clinician (e.g., an intervention cardiologist, surgeon, etc.) in a desired alignment and / or orientation with respect to specific anatomical features of the natural heart valve, such that specific features of the artificial heart valve are aligned with corresponding features of the natural heart valve. For example, the commissure and / or leaflets of the artificial heart valve may be aligned with the natural commissure and / or leaflets of the natural heart valve. Aligning the artificial heart valve with the natural heart valve when it is deployed to the target therapeutic site may be beneficial so that the artificial heart valve functions similarly to the normal function of the natural heart valve.

[0006] In some embodiments, an artificial heart valve may be radially compressed in a folded state on a deflated balloon attached to a balloon catheter. When the artificial heart valve is folded, it defines a lumen smaller than the diameter of the balloon when inflated. This means that the entire membrane material of the balloon will fit into the lumen of the folded valve by the deflated balloon being folded or pleated so that the balloon fits into the lumen of the folded valve. When the balloon inflates, the membrane material of the balloon expands outward, putting pressure on the inner surface of the valve. This expands the valve and therefore increases the diameter of the lumen defined by the valve. When the balloon inflates, it pleats and / or deforms, and the balloon eventually achieves a round cross-section without pleats and / or folds.

[0007] In some cases, the alignment of an artificial heart valve relative to the natural heart valve may change as the artificial heart valve transitions from a folded to an expanded state. For example, the balloon of some balloon catheters applies a rotational force to the artificial heart valve when it expands in response to balloon inflation, due to the balloon being folded or pleated within the folded artificial heart valve in a specific manner. This can cause the artificial heart valve to rotate relative to the natural heart valve, potentially altering its alignment relative to the natural heart valve in an undesirable way. This means that it is beneficial for clinicians to properly align the valve before inflating the balloon and to limit the amount of valve rotation during expansion so that the alignment does not change significantly when the balloon is inflated. As described herein, exemplary systems may include a balloon that is pleated and folded in a specific manner so that the balloon does not apply a rotational force to the artificial heart valve when the balloon expands. Therefore, by using the balloon fold arrangement and techniques described herein, the alignment of the prosthetic valve with respect to the innate valve before deployment is the same as, or very similar to, the alignment of the prosthetic valve with respect to the innate valve after deployment.

[0008] In one embodiment, the balloon catheter system includes a delivery shaft and a balloon fixedly attached to the delivery shaft. When the balloon is deflated, the membrane material of the balloon defines a plurality of folded portions extending along the longitudinal axis of the delivery shaft. The balloon catheter system also includes an artificial heart valve positioned on the balloon when the balloon is deflated and the artificial heart valve is folded, wherein a first set of folded portions of the plurality extends clockwise around the longitudinal axis of the delivery shaft, and a second set of folded portions of the plurality extends counterclockwise around the longitudinal axis of the delivery shaft.

[0009] In another embodiment, a balloon catheter for delivering an artificial heart valve to a target site in a patient's natural valve includes a delivery shaft and a balloon fixedly attached to the delivery shaft. When the balloon is deflated, the membrane material of the balloon defines a plurality of folded portions extending along the longitudinal axis of the delivery shaft. When the balloon is positioned within the artificial heart valve while the balloon is deflated and the artificial heart valve is folded, a first set of the folded portions extends clockwise around the longitudinal axis of the delivery shaft, and a second set of the folded portions extends counterclockwise around the longitudinal axis of the delivery shaft.

[0010] In another embodiment, a method for pleating a balloon attached to a delivery shaft includes inflating the balloon such that its cross-section is substantially circular, and moving a set of pleating heads radially inward, each pleating head of the set of pleating heads pushing the balloon's membrane material inward to define one of a set of recesses. Each pleating head is provided with pleating teeth located at the distal end of each pleating head. The method also includes installing a pleating nut to secure the pleating teeth of each pleating head, securing the set of recesses, and retracting the set of pleating heads radially outward, leaving the pleating teeth corresponding to each pleating head secured to the pleating nut. This method also includes moving a set of folding heads radially inward, such that each folding head in the set of folding heads pushes the balloon membrane material inward to define a plurality of folded portions, and arranging the plurality of folded portions such that a first set of folded portions extends clockwise around the longitudinal axis of the delivery shaft, and a second set of folded portions extends counterclockwise around the longitudinal axis of the delivery shaft.

[0011] Certain embodiments of the subject matter described herein may be implemented to achieve one or more of the following advantages: In some embodiments, the deflated balloon is pleated and folded to fit within the lumen of an artificial heart valve, and the artificial heart valve is then radially pressed onto the balloon. For example, the membrane of the deflated balloon can be folded itself to form a fold, which extends parallel to the longitudinal axis of the balloon catheter. These folds can be positioned so as to extend in both rotational directions (e.g., both counterclockwise and clockwise) about the longitudinal axis of the balloon catheter, and so as not all of the folds extend in the same direction. If the folds extend or are deflected in both clockwise and counterclockwise directions, it is possible to prevent or substantially limit the rotation of the artificial valve, which may otherwise be induced by the balloon when the balloon expands, while the balloon is being inflated. This improves the clinician's ability to align the prosthetic valve with the natural valve before inflating the balloon and expanding the valve, compared to prosthetic valve delivery systems where the folds extend or are deflected in the same direction (e.g., all clockwise, all counterclockwise, mostly clockwise, or mostly counterclockwise). The equal number of opposingly extending overlapping portions facilitate the substantial continuation of the prosthetic valve's alignment with the natural valve as the prosthetic valve expands, thereby allowing the clinician to align specific features of the prosthetic valve (e.g., commissure, leaflets, etc.) with corresponding features of the natural valve (e.g., commissure, leaflets, etc.) before inflating the balloon. The prosthetic valve maintains this alignment during expansion / deployment.

[0012] In some embodiments, the pleating and folding device is advantageous if it is configured to form pleats and folds within a deflated balloon. For example, the pleating device may include a set of fold heads and a set of pleat heads that compress the outer surface of the balloon inward to form a set of folds. Each fold represents a portion of the deflated balloon membrane that folds over. The balloon folds may be positioned so that the balloon fits into the lumen of a folded artificial heart valve. When the balloon inflates, fluid fills and deforms the balloon folds, causing the balloon to exert pressure on the inner wall of the artificial heart valve. When the balloon expands outward, this transitions the balloon from a deflated state to an expanded state, while limiting the rotation of the artificial heart valve to below a threshold rotation.

[0013] In some embodiments, the balloon can form one or more advantageous patterns while deflated, which ultimately expand the artificial heart valve radially outward while restricting rotation as the balloon is inflated. For example, pleats can be formed by creating folds in the balloon's membrane. A fold is a portion of the membrane that is folded so that it forms an inverse loop and contacts itself. These folds may include one or more folds deflected in a first direction (e.g., extending clockwise around the longitudinal axis of the balloon) and one or more folds deflected in a second direction (e.g., extending counterclockwise around the longitudinal axis of the balloon) while the deflated balloon is positioned within the lumen of the artificial heart valve. When the balloon inflates, the folds deflected in the first direction exert outward radial and tangential forces, and the folds deflected in the second direction exert outward radial and tangential forces. The tangential forces of folds deflected in opposite directions cancel each other out, and the outward radial forces of folds deflected in opposite directions cooperate to radially expand the artificial heart valve. Thus, balloons folded in the pattern described herein provide improved techniques and results for expanding artificial heart valves. Specifically, balloons folded in the pattern described herein reduce the amount of valve rotation when the valve expands compared to balloon catheters with folds deflected so that the deflated balloon extends in the same direction.

[0014] A pleated balloon can form one or more open pleats defined by folds in the membrane to form open recesses. In some embodiments, these open and closed recesses are linear and extend parallel to the longitudinal axis of the balloon. This means that as the balloon inflates and the folds deform, the recesses expand radially outward. Because the recesses are linear, rotation of the balloon material is restricted, and therefore the rotation of the artificial heart valve is limited to below a threshold amount of rotation.

[0015] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art in which the invention pertains. The invention can be carried out using methods and materials similar or equivalent to those described herein, but preferred methods and materials are described herein. All publications, patent applications, patents, and other references referenced herein are incorporated in their entirety by reference. In case of any conflict, this specification, including definitions, shall prevail. Furthermore, the substances, methods, and examples are illustrative and not intended to limit the scope.

[0016] Details of one or more embodiments of the present invention are described in the accompanying drawings and this specification. Other features, purposes, and advantages of the present invention will become apparent from the description and drawings and the claims. [Brief explanation of the drawing]

[0017] [Figure 1] This is a perspective view of an exemplary medical device delivery system according to some embodiments described herein. [Figure 2] Figure 1 is an enlarged perspective view of an exemplary distal end portion of a medical device delivery system. [Figure 3] Figure 1 is an enlarged perspective view of an exemplary handle for a medical device delivery system. [Figure 4] Figure 1 is a fractured view from the fracture site of an exemplary distal end portion of a medical device delivery system. [Figure 5] This is a plan view of the distal end portion of the medical device delivery system in Figure 1 of the delivery configuration. [Figure 6] This is a plan view of the distal end portion of the medical device delivery system in Figure 1 in the intermediate configuration. [Figure 7] This is a plan view of the distal end portion of the medical device delivery system in Figure 1 in the extended configuration. [Figure 8A] This is a perspective view of the distal end portion of the medical device delivery system shown in Figure 1, without an implantable medical device. [Figure 8B]Perspective view of an exemplary valve stop member according to some embodiments. [Figure 9A] An enlarged version of a sectional view showing one or more forces applied to an artificial heart valve by a balloon of the balloon catheter of FIG. 4. [Figure 9B] A sectional perspective view showing a state in which a balloon arranged according to the pattern shown in FIG. 9A fits into the lumen of a folded artificial heart valve. [Figure 10] A view of a series of break positions of the balloon. [Figure 11] A sectional view showing a balloon in a contracted state while being disposed within the lumen of an artificial heart valve in a compressed state at each of the break positions of FIG. 10. [Figure 12] A sectional view showing a balloon in a contracted state while being disposed within the lumen of an artificial heart valve in a compressed state at each of the break positions of FIG. 10. [Figure 13] A sectional view showing a balloon in a contracted state while being disposed within the lumen of an artificial heart valve in a compressed state at each of the break positions of FIG. 10. [Figure 14] A sectional view showing a balloon in a contracted state while being disposed within the lumen of an artificial heart valve in a compressed state at each of the break positions of FIG. 10. [Figure 15] A sectional view showing a balloon in a contracted state while being disposed within the lumen of an artificial heart valve in a compressed state at each of the break positions of FIG. 10. [Figure 16] A sectional view showing a balloon in a contracted state while being disposed within the lumen of an artificial heart valve in a compressed state at each of the break positions of FIG. 10. [Figure 17] A sectional view showing a balloon in a contracted state while being disposed within the lumen of an artificial heart valve in a compressed state at each of the break positions of FIG. 10. [Figure 18] A sectional view showing a balloon in a contracted state while being disposed within the lumen of an artificial heart valve in a compressed state at each of the break positions of FIG. 10. [Figure 19]This figure shows a pleating tool for pleating a balloon to fit into the recess of a folded artificial heart valve. [Figure 20] This figure shows a pleating tool for pleating a balloon at a second pleating position where the pleating head and pleating teeth extend inward to create a series of cavities. [Figure 21] This figure shows a pleating tool for pleating a balloon in a third pleating position, where the pleating head is retracted, the pleating teeth secure a cavity within the balloon, and the pleating nut is attached to fix the pleating teeth in place. [Figure 22] This figure shows a pleating tool for pleating a balloon in a fourth pleating position, where the pleating head is retracted and the pleating teeth are secured by a pleating nut, creating a cavity within the balloon. [Figure 23] This figure shows a pleating tool for pleating a balloon, with the folding head advanced to a fifth pleating position where it creates an overlapping section in the balloon membrane. [Figure 24] This figure shows a pleating tool for pleating a balloon in a sixth pleating position where the pleating head and the folding head are retracted and the folded portion of the balloon membrane is secured by vacuum. [Figure 25] This flowchart illustrates an exemplary procedure for inflating a balloon catheter containing a pleated balloon with a linear recess. [Modes for carrying out the invention]

[0018] This specification relates to delivery systems for medical devices and methods of using the same. For example, this specification relates to delivery systems for implantable medical devices, such as artificial heart valves, that can be delivered minimally invasively using a balloon catheter. In some embodiments, the delivery system includes a balloon catheter, which includes a balloon attached to the distal end of the balloon catheter, and an artificial heart valve positioned on the balloon in a radially compressed or folded state. When the balloon is deflated, the membrane material of the balloon may be pleated and folded into a specific pattern that can be expanded while limiting the rotational force applied to the artificial heart valve, as further described herein. For example, a deflated balloon may include a plurality of overlapping portions extending in opposite directions around the longitudinal axis of the balloon. This ensures that when the overlapping portions expand and unfold radially, the overlapping portions do not apply a net rotational force to the artificial heart valve that would rotate the valve when it is radially expanded.

[0019] Figure 1 shows an exemplary transcatheter medical device delivery system 100. In the example shown, the medical device delivery system 100 is configured to deliver an artificial heart valve to the site of the original heart valve by advancing the artificial heart valve to the heart through the patient's vascular system. For example, in some embodiments, the medical device delivery system 100 may be used to deliver an artificial aortic valve to the site of the original aortic valve via the patient's aorta. This non-limiting type of use of the medical device delivery system 100 is used as an example herein to illustrate the function of the medical device delivery system 100. In such a case, the medical device delivery system 100 may be inserted into the femoral artery via a sheath and then advanced into the aorta, through the aortic arch, to the site of the original aortic valve. Transclavian, transcarotid, transradial, and other alternative approaches using the medical device delivery system 100 are also conceivable.

[0020] Generally, the medical device delivery system 100 includes a clinician control handle 110 (or simply "handle 110"), a maneuverable catheter 160, and an elongated catheter 170 (hereinafter referred to as balloon catheter 170). The maneuverable catheter 160 and balloon catheter 170 each extend distally from the handle 110. The maneuverable catheter 160 and balloon catheter 170 are each attached to the handle 110, but at different positions on the handle 110 (as further described below).

[0021] In some embodiments, the medical device delivery system 100 is configured to deliver the artificial heart valve to the location of the original heart valve under visualization from one or more medical imaging systems. These medical imaging systems may include X-ray systems, computed tomography (CT) systems, or other types of medical imaging systems. This visualization allows the clinician to see, among other things, the location of the medical device delivery system 100 relative to the site of the original aortic valve, and the orientation of the artificial heart valve relative to the original aortic valve.

[0022] In some embodiments, the distal portions of the balloon catheter 170 and the maneuverable catheter 160 can be inserted into the patient's vascular system while the handle 110 remains outside the patient's body. The clinician can further guide the medical device delivery system 100 into the patient, retract the medical device delivery system 100 from the patient, and control the maneuverable catheter 160 and balloon catheter 170 by using one or more actuators on the handle 110.

[0023] Figure 2 shows the distal end portion of the maneuverable catheter 160 and a magnified view of the balloon catheter 170. An exemplary balloon 174 and an exemplary artificial heart valve 300 are mounted on the balloon catheter 170 in a low-profile delivery configuration.

[0024] The maneuverable catheter 160 defines the lumen in which the balloon catheter 170 is slidably positioned. That is, the balloon catheter 170 can be advanced and / or retracted relative to the maneuverable catheter 160 by being manipulated by a clinician (using the handle 110) to slide the balloon catheter 170 within the lumen of the maneuverable catheter 160. For example, in some cases, the maneuverable catheter 160 can be retracted proximal to the balloon catheter 170 and the artificial heart valve 300, as will be further described below.

[0025] The maneuverable catheter 160 is controllable deflection or maneuverability by a clinician (by manipulating the pull wire using the handle 110, as further described below with reference to Figure 3). In particular, the distal end portion of the maneuverable catheter 160 is controllable deflection to any desired angle, up to approximately 180°, or even beyond 180° in some embodiments. When the maneuverable catheter 160 is deflected in this manner, the balloon catheter 170 is deflected to the same extent (as the balloon catheter 170 is positioned within the lumen of the maneuverable catheter 160). The deflection of the maneuverable catheter 160 (and the balloon catheter 170) may be useful, for example, for navigating the aortic arch. In some embodiments, the balloon catheter 170 (and the maneuverable catheter 160) can be advanced along a pre-installed guidewire.

[0026] Referring further to Figure 2, the balloon catheter 170 includes an inner catheter shaft 172 and a balloon 174 attached to the distal end of the balloon catheter 170. The inner catheter shaft 172 defines an inflatable lumen and one or more openings (not visible) from which inflation fluid can be supplied and retrieved to controllably inflate and / or deflate the balloon 174. In addition, the inner catheter shaft 172 defines a central lumen, which allows the balloon catheter 170 (and the maneuverable catheter 160) to advance along the guidewire.

[0027] In the illustrated embodiment, a tapered nose cone 178 is attached to the distal end portion of the inner catheter shaft 172 and the balloon 174. The tapered nose cone 178 extends distally from the balloon 174 and provides a distal end that does not damage the medical device delivery system 100. In some examples, the tapered nose cone 178 may have a rounded distal end without sharp edges so that the balloon catheter 170 can navigate through the patient's vascular system without puncturing or otherwise damaging the patient's tissue. In some embodiments, the surface of the nose cone is gently angled inward toward the longitudinal axis of the balloon catheter 170, thereby causing the diameter of the tapered nose cone 178 to gradually decrease distally along the tapered nose cone 178. In some cases, this gradual tapering of the tapered nose cone 178 allows the nose cone to gradually increase the diameter of the narrow passage within the patient's anatomical structure, enabling the balloon catheter 170 to advance through the vascular system without damaging the tissue.

[0028] The artificial heart valve 300 can be radially crimped onto the balloon 174 and present on the balloon in a radially compressed, thin-profile delivery configuration. When the crimped artificial heart valve 300 is on the balloon 174 in preparation for deployment, the artificial heart valve 300 is in a folded state and the balloon 174 is in a deflated state. In some embodiments, the artificial heart valve 300 includes a metal stent frame. In some examples, the frame comprises a single piece of material configured to transition from a folded state to an expanded, operational state in response to the balloon 174 expanding from a deflated state to an inflated state.

[0029] As will be described in more detail below, the frame of the artificial heart valve 300 may include a set of commissure columns. In some examples, these commissure columns may resemble the commissures of a natural heart valve. For example, the artificial heart valve 300 may include three commissures, the same number as most natural aortic valves. In some embodiments, the set of artificial heart valve leaflets of the artificial heart valve 300 may include three artificial heart valve leaflets, the same number as most natural aortic valves. In some embodiments, the frame of the artificial heart valve 300 may include a set of intermediate connectors, each intermediate connector in the set of intermediate connectors spaced apart between each pair of consecutive commissure columns. In embodiments in which the frame includes three commissure columns, the frame may include three intermediate connectors.

[0030] In some embodiments, the artificial heart valve leaflets of the artificial heart valve 300 may be attached to the frame at the commissure pillars of the frame. For example, each artificial heart valve leaflet may be attached to two commissure pillars, with one commissure pillar at each end of the leaflet. In some embodiments, the artificial heart valve 300 includes three commissure pillars and three artificial leaflets, corresponding to the three commissures and three leaflets of most natural aortic valves. It may be beneficial to align the orientation of the commissure pillars and artificial leaflets of the artificial heart valve 300 with the orientation of the commissures and leaflets of the natural aortic valve. This may involve rotating the artificial heart valve 300 relative to the natural aortic valve such that, when the artificial heart valve 300 is expanded, each of the commissure pillars of the frame occupies a rotational position similar to the rotational position of the corresponding natural aortic commissure, and each artificial heart valve leaflet of the artificial heart valve 300 occupies a rotational position similar to the rotational position of the corresponding natural aortic leaflet.

[0031] The deflated balloon 174 is sized to fit within the lumen of the folded artificial heart valve 300 such that the maximum diameter of the deflated balloon 174 is less than or equal to the diameter of the lumen of the folded artificial heart valve 300. For example, the balloon 174 may include a membrane containing a malleable material such as nylon, polyurethane, polyethylene terephthalate (PET), or another material. When the balloon 174 is deflated, this membrane material can be manipulated into a pleated pattern so that the balloon 174 fits within the lumen of the folded artificial heart valve 300, even when the diameter of the lumen is smaller than the diameter of the balloon when inflated.

[0032] In some embodiments, the pleated and folded pattern of the balloon 174 within the lumen of the folded artificial heart valve 300 can define a plurality of recesses. For example, when the balloon 174 is deflated within the lumen of the folded artificial heart valve 300, the balloon may be pleated and folded to accommodate excess membrane material so that the cross-section of the balloon 174 is small enough to fit within the lumen of the folded artificial heart valve 300. By folding the excess membrane material, a plurality of folds and / or overlaps can be obtained. These plurality of folds and / or overlaps can define one or more recesses. In some embodiments, the recesses defined by the membrane material of the balloon 174 within the lumen of the folded artificial heart valve 300 are substantially linear and parallel to the longitudinal axis of the inner catheter shaft 172 of the balloon catheter 170.

[0033] To position the folded portion of the deflated balloon 174 so that it fits within the lumen of the folded artificial heart valve 300, the folded portion may be deflected by rotation around the longitudinal axis of the balloon catheter 170. For example, before deflection, each folded portion of a plurality of folded portions may extend radially outward with respect to the longitudinal axis of the balloon catheter 170. One or more of the folded portions may be deflected or coiled clockwise around the longitudinal axis of the balloon catheter 170, or one or more of the folded portions may be deflected or coiled counterclockwise around the longitudinal axis of the balloon catheter 170, such that the maximum diameter of the cross-section of the deflated balloon 174 is less than or equal to the diameter of the folded artificial heart valve 300. When an equal number of folded portions are deflected or wound so as to extend in different / opposite directions (clockwise versus counterclockwise) around the longitudinal axis of the balloon catheter 170, this causes the folded portions to exert opposing rotational forces on the artificial heart valve 300 during expansion, thereby preventing or substantially limiting the rotation of the artificial heart valve 300 during expansion.

[0034] In some embodiments, the balloon 174 can rotate around the longitudinal axis of the balloon catheter 170 when the balloon 174 is in a folded state. This means that the balloon catheter 170 can rotate when it is inserted into the patient's body. In some examples, when the balloon catheter 170 rotates, the artificial heart valve 300 and the balloon 174 also rotate with the balloon catheter 170. This means that when the artificial heart valve 300 is advanced to a target site in the patient, such as the site of the natural aortic valve, the balloon catheter 170 can rotate so that the artificial heart valve 300 is properly aligned with the natural aortic valve. In some embodiments, the balloon catheter 170 rotates relative to a maneuverable catheter 160, so that the maneuverable catheter 160 remains in place when the balloon catheter 170 rotates. Since the shafts of the balloon catheter 170 (e.g., the inner catheter shaft 172 and / or the outer catheter shaft) can be slidably positioned within the lumen of the maneuverable catheter 160, the shafts of the balloon catheter 170 can rotate within the lumen of the maneuverable catheter 160, thereby rotating the artificial heart valve 300 without rotating the maneuverable catheter 160.

[0035] As will be further described below, once the balloon 174 and the artificial heart valve 300 are positioned at the target location and in the desired orientation relative to the patient's anatomical structure, the balloon 174 can inflate the artificial heart valve 300, expanding radially and engaging with the patient's innate anatomical structure (e.g., engaging with the annulus of a natural heart valve, such as the natural aortic valve). The balloon 174 can then be deflated and retracted from the artificial heart valve 300. In some embodiments, radiopaque markers may be placed at the location of one or more of the maneuverable catheter 160, balloon catheter 170, artificial heart valve 300, or any combination thereof. This can provide visualization of the maneuverable catheter 160, balloon catheter 170, and artificial heart valve 300 under fluoroscopy so that the clinician can see the location of the maneuverable catheter 160, balloon catheter 170, and artificial heart valve 300 relative to the patient's anatomical structure. In some cases, radiopaque markers and / or other reference markers can provide visualization of the orientation of the prosthetic heart valve 300 relative to the innate aortic valve.

[0036] When balloon 174 is inflated, this expands the membrane material of balloon 174 outward relative to the shaft of balloon catheter 170, and also expands the artificial heart valve 300. For example, when balloon 174 transitions from a deflated state to an inflated state, this expands the artificial heart valve 300 from a folded state to an expanded state. During the expansion of the artificial heart valve 300, the diameter of the artificial heart valve 300 may increase in response to the pressure that balloon 174 exerts on the inner wall of the artificial heart valve 300 as it inflates. This pressure exerted by balloon 174 includes, in some examples, one or more radial and / or rotational forces exerted by the folded portion of the balloon membrane as the folded portion deforms or unfolds in response to the expansion. When the balloon 174 is positioned within the lumen of the artificial heart valve 300, if the folded portion of the deflated balloon 174 is wound so that it extends in opposite directions around the longitudinal axis of the balloon catheter 170, this can cause opposing rotational forces that cancel each other out to be applied to the folded portion of the balloon 174, thereby limiting the rotation of the artificial heart valve 300 during expansion to less than a threshold rotation. For example, the artificial heart valve 300 can expand radially outward when the balloon 174 is inflated. In some embodiments, the difference between the rotational position of the artificial heart valve 300 in the folded state and the rotational position of the artificial heart valve 300 in the expanded state is less than a threshold rotation. In some examples, this threshold rotation is 5 degrees, 10 degrees, or 20 degrees.

[0037] Figure 3 shows an enlarged view of an exemplary handle 110 of the medical device delivery system 100. The handle 110 remains outside the patient's body, while the maneuverable catheter 160, balloon catheter 170, and artificial heart valve 300 extend into the patient's body (e.g., into the patient's vascular system and / or heart). The handle 110 includes several control mechanisms, as will be further described below, which allow a clinician operator to remotely control various aspects of the maneuverable catheter 160 and balloon catheter 170. The maneuverable catheter 160 is fixed to the handle 110.

[0038] In this figure of the handle 110, the following components and / or control mechanisms of the handle 110 are visible. Namely, the handle 110 includes a housing 112, a rotatable first actuator knob 114, a lock actuator 116, a rotatable second actuator knob 118, a balloon catheter pull rod 120, a filling line 122, a flush line 124, and an optional deflection indicator 180.

[0039] The first actuator knob 114, the second actuator knob 118, and the lock actuator 116 are each manually rotatable relative to the housing 112. The maneuverable catheter 160 can be deflected laterally by rotation of the first actuator knob 114. That is, manual rotation of the first actuator knob 114 can be used to control the degree of deflection of the maneuverable catheter 160 (and the balloon catheter 170 placed therein) by pulling or releasing a pull wire (not shown). A deflection indicator 180 can provide an indicator of the degree of deflection of the maneuverable catheter 160. The second actuator knob 118 can be rotated to rotate the balloon catheter 170 (and the artificial heart valve 300) relative to the maneuverable catheter 160.

[0040] The proximal end of the balloon catheter 170 is attached to the balloon catheter pull rod 120. The balloon catheter pull rod 120 is manually translatable relative to the housing 112 (when the lock actuator 116 is in its unlocked position). The balloon catheter pull rod 120 can be extended and retracted relative to the housing 112 to extend and retract the balloon catheter 170 (and the artificial heart valve 300) relative to the maneuverable catheter 160. The lock actuator 116 may be used to lock and unlock the mobility of the balloon catheter pull rod 120 relative to the housing 112.

[0041] In some examples, the filling line 122 may be configured to deliver fluid and remove fluid from the balloon 174 of the balloon catheter 170. For example, the filling line 122 may connect to the balloon catheter pull rod 120, the maneuverable catheter 160, and a filling lumen extending through the balloon catheter 170 to reach the balloon 174. To inflate the balloon 174, fluid may be introduced through the fluid line 122 so that the fluid flows into the interior of the balloon 174. As the volume of fluid in the balloon 174 increases, this causes the membrane of the balloon 174 to expand radially outward, adapting to the increasing volume of fluid in the balloon 174. This causes the balloon 174 to pressurize the inner surface of the prosthetic heart valve 300, causing the prosthetic heart valve 300 to expand radially. To deflate the balloon, the operator, who is a clinician, can release the fluid through the filling line 122. The handle 110 may also include a flush line 124 containing an actuator 125.

[0042] Figure 4 shows a cross-sectional view of the inner catheter shaft 172, balloon 174, and artificial heart valve 300 at position X (Figure 2) along the balloon catheter 170. In the embodiment of Figure 4, the artificial heart valve 300 is in a folded state and the balloon 174 is deflated. In the folded state, the artificial heart valve 300 defines the lumen 176. The balloon 174 is positioned within the lumen 176, and the inner catheter shaft 172 extends longitudinally through the center of the lumen 176.

[0043] Within the lumen 176 of the folded artificial heart valve 300, the lumen of the balloon 174 is formed in an exemplary pattern including a plurality of folded portions, in some embodiments. As seen in Figure 4, the plurality of folded portions (or simply “folds”) include a first set of folds 322, 324, 326, and 328 (“322-328”) and a second set of folds 342, 344, 346, and 348 (“342-348”). In some embodiments, each of the first set of folds 322-328 is deflected or wound to extend in a first rotational direction (e.g., counterclockwise in the illustrated embodiment) about the longitudinal axis of the balloon catheter 170, and each of the second set of folds 342-348 is deflected in a second rotational direction (e.g., clockwise in the illustrated embodiment) about the longitudinal axis of the balloon catheter 170. In the example in Figure 4, there are a total of eight folded sections. The first set of folds 322-328 includes four folds (i.e., folds 322, 324, 326, and 328), and the second set of folds 342-348 includes four folds (i.e., folds 342, 344, 346, and 348). In other embodiments, other total numbers of folds may include, for example, two folds, four folds, six folds, ten folds, twelve folds, and so on.

[0044] In embodiments where the number of folds in the balloon 174 deflected in the first direction is equal to the number of folds in the balloon 174 deflected in the second direction, the rotational forces applied to the artificial heart valve 300 by expanding the folds cancel each other out, thereby substantially eliminating or reducing the rotation of the artificial heart valve 300 when the balloon 174 expands to less than a threshold amount. For example, when the balloon 174 expands, fold 322 is deflected in a counterclockwise direction, so fold 322 can apply force to the inner surface of the artificial heart valve 300 radially outward with respect to the longitudinal axis of the balloon catheter 170, and the rotation extends clockwise. Fold 346 is deflected in a clockwise direction, so fold 346 can apply force to the inner surface of the artificial heart valve 300 radially outward with respect to the longitudinal axis of the balloon catheter 170, and the rotation extends counterclockwise. In some embodiments, the rotational forces applied by folds 322 and 346 cancel each other out, thereby preventing substantial rotation of the artificial heart valve 300. The radial forces applied by folds 322 and 346 to the inner surface of the artificial heart valve 300 can cause the artificial heart valve 300 to expand from a folded state to an extended state.

[0045] The first set of folds 322-328 and the second set of folds 342-348 may be formed when the balloon 174 is pleated and folded so that it is located within the lumen 176 of the artificial heart valve 300, which is radially compressed onto the balloon. The balloon 174 can be inflated to a diameter larger than the diameter of the lumen 176 of the artificial heart valve 300 in its folded state. This means that the excess portions of the membrane of the balloon 174 are folded together and arranged to compress the balloon 174 to a smaller diameter. In some embodiments, the balloon 174 is folded and arranged as shown in Figure 4, but this is not the only possible arrangement of the balloon 174. The balloon 174 may be folded and arranged in one or more other configurations that result in a balloon 174 having a diameter that fits within the lumen of the artificial heart valve 300. These one or more configurations may include folds that are deflected in opposite directions so that the rotational force applied to the artificial heart valve 300 during expansion is offset and limits the rotation of the artificial heart valve 300. When balloon 174 is fully inflated, the membrane of balloon 174 is fold-free, and the cross-section of balloon 174 is round (e.g., circular). However, the diameter of balloon 174 is significantly larger when balloon 174 is inflated compared to when balloon 174 is deflated, pleated, folded, and fitted into the lumen 176 of the folded artificial heart valve 300. Pleating and folding the deflated balloon 174 presents one useful method for reducing the maximum diameter of balloon 174 to fit it into the lumen 176.

[0046] In some embodiments, folds in the balloon 174 (e.g., a first set of folds 322-328 and a second set of folds 342-348) are positioned within the lumen 176 of the folded artificial heart valve 300 to form one or more recesses. These recesses include closed recesses and open recesses. For example, folds 324 and 348 bend inward toward each other to form a closed recess 352 as a closed channel, thus forming a closed recess 352. In some examples, the closed recess 352 extends substantially along the balloon 174 along the longitudinal axis of the balloon catheter 170. The closed recess 352 is not the only closed recess formed by the membrane of the balloon 174. Any gap formed by folds of membrane that are deflected inward and overlapping may constitute a closed recess. Folds 322 and 354 bend away from each other so that the open recess 354 is an open channel, thus forming the open recess 354. In some examples, the open recess 354 extends substantially along the longitudinal axis of the balloon catheter 170 and along the balloon 174. The open recess 354 is not the only open recess formed by the membrane of the balloon 174. Any open channel formed by a pair of folds deflecting away from each other is an open recess.

[0047] Figure 5 provides another diagram of the distal end portion of the medical device delivery system 100, including a maneuverable catheter 160 and a balloon catheter 170. In the example of Figure 5, the folded artificial heart valve 300 is mounted on a deflated balloon 174. The maneuverable catheter 160 and the artificial heart valve 300 are mounted on the balloon catheter 170. The tapered nose cone 178 and inner catheter shaft 172 of the balloon catheter 170 are also visible. The configuration shown in Figure 5 is a delivery configuration used when advancing the distal end portion of the medical device delivery system 100 and the artificial heart valve 300 to a target site (e.g., the innate heart valve region) for deployment of the artificial heart valve 300 within the patient. For example, the artificial heart valve 300 may be in a folded state during advancement to the target site, and as a result, the diameter of the distal end portion of the medical device delivery system 100 is small enough for the artificial heart valve 300 to navigate through the patient's vascular system to the target site.

[0048] In addition, a valve stop member 190 is shown. The valve stop member 190 is attached to the inner catheter shaft 172 of the balloon catheter 170 and is located inside the balloon 174. The valve stop member 190 engages with the distal end of the artificial heart valve 300 to prevent the artificial heart valve 300 from advancing distally beyond the valve stop member 190 when the artificial heart valve 300 is in a folded state. This can help to hold the artificial heart valve 300 in place as the balloon catheter 170 advances to the target site of the patient. Furthermore, this can help to rotate the artificial heart valve 300 together with the balloon catheter 170 when the balloon catheter 170 is rotated while the artificial heart valve 300 is in a folded state. Additional features of the valve stop member 190 are described below.

[0049] In the illustrated delivery configuration, the artificial heart valve 300 is compressed longitudinally in a folded state and securely captured between the flared distal end 162 of the maneuverable catheter 160 and the valve stop member 190. The flared distal end 162 defines an annular space that receives and covers the end portion of the artificial heart valve 300. That is, the end portion of the artificial heart valve 300 (e.g., the metal stent frame of the artificial heart valve 300) is concealed by the flared distal end 162 of the maneuverable catheter 160. This arrangement helps prevent potential damage to the vascular wall that the end portion of the artificial heart valve 300 might suffer if it were exposed (rather than being concealed by the flared distal end 162 of the maneuverable catheter 160). Thus, during transvascular advancement of the illustrated configuration, the covering of the end portion of the artificial heart valve 300 by the flared distal end 162 reduces the risk of vascular wall damage that could occur if the end portion comes into contact with the vascular wall.

[0050] The other end of the artificial heart valve 300 is held in place by a valve stop member 190. The valve stop member 190 prevents the artificial heart valve 300 from moving distally despite the longitudinal force from the flared distal end 162 of the maneuverable catheter 160, a force that would cause such distal movement if the stop member were absent. Thus, the artificial heart valve 300 can be trapped between the maneuverable catheter 160 and the valve stop member 190 when the artificial heart valve 300 is in a folded state. The flared distal end 162 and the valve stop member 190 can fix the artificial heart valve 300 in place so that the maneuverable catheter 160 and the balloon catheter 170 do not have sharp leading edges. This allows the balloon catheter 170 to advance through the patient's vascular system to the target site without damaging the patient's tissue.

[0051] Since the valve stop member 190 is located inside the balloon 174, the layer of flexible wall material of the balloon 174 is located between the artificial heart valve 300 and the valve stop member 190. In the illustrated delivery configuration, the flexible wall material of the balloon 174 is compressed between the artificial heart valve 300 and the valve stop member 190.

[0052] Figure 6 shows a later stage of the delivery / deployment process of the artificial heart valve 300 using the medical device delivery system 100. Compared to the arrangement in Figure 4, here the maneuverable catheter 160 is pulled back proximal to the balloon catheter 170 and / or the balloon catheter 170 is pushed distal to the maneuverable catheter 160. As seen in the example in Figure 6, when the balloon catheter 170 is displaced from the maneuverable catheter 160, the artificial heart valve 300 remains attached in a folded state on the balloon 174 of the balloon catheter 170.

[0053] In some cases, the balloon catheter 170 can be pushed away from or pulled toward the maneuverable catheter 160 based on user control of the balloon catheter pull rod 120 shown in Figure 3. For example, pulling the balloon catheter pull rod 120 proximal to the maneuverable catheter 160 pulls the balloon catheter 170 toward the maneuverable catheter 160, and pushing the balloon catheter pull rod 120 distal to the maneuverable catheter 160 pushes the balloon catheter 170 away from the maneuverable catheter 160. In some cases, the maneuverable catheter 160 and the balloon catheter 170 can be separated from each other, as shown in Figure 6, when the artificial heart valve 300 is close to the target therapeutic site.

[0054] The illustrated configuration clarifies that the balloon catheter 170 also includes the outer catheter shaft 173. The inner catheter shaft 172 extends distally from the outer catheter shaft 173. The proximal end of the balloon 174 is attached to the distal end portion of the outer catheter shaft 173. The distal end of the balloon 174 is attached to a tapered nose cone 178, which is attached to the distal end portion of the inner catheter shaft 172. The valve stop member 190 is located inside the balloon 174 and is longitudinally positioned between the outer catheter shaft 173 and the tapered nose cone 178. The valve stop member 190 is closer to the tapered nose cone 178 than to the distal end of the outer catheter shaft 173.

[0055] Figure 7 shows yet another later stage of the delivery / deployment process of the artificial heart valve 300 using the medical device delivery system 100. In this configuration, the balloon 174 is inflated, and the artificial heart valve 300 is consequently expanded radially. This expansion of the artificial heart valve 300 can be performed, for example, once the artificial heart valve 300 is properly positioned longitudinally and / or rotationally relative to the innate heart valve annulus. That is, the unexpanded artificial heart valve 300 can be properly positioned relative to the innate anatomical structure, and then the artificial heart valve 300 can be expanded by the inflation of the balloon 174 while remaining aligned with the innate anatomical structure. Thus, the balloon catheter 170 is part of an improved system for expanding the artificial heart valve 300 while maintaining the orientation of the artificial heart valve 300 relative to the innate heart valve. This involves expanding the artificial heart valve 300 while limiting the rotation of the artificial heart valve 300 to less than a threshold rotation amount. In some examples, this threshold rotation amount is 10 degrees.

[0056] The balloon 174 is pleated, folded, and positioned such that it includes folds that are deflected both clockwise and counterclockwise while the balloon 174 is positioned in the lumen 176 of the artificial heart valve 300 in a folded state. These folds apply pressure to the inner surface of the artificial heart valve 300 as the balloon 174 inflates, causing the artificial heart valve 300 to expand radially outward while limiting its rotation to less than a threshold amount. For example, the positioning of the balloon 174 ensures that the rotational force applied to the artificial heart valve 300 by the folds of the balloon 174 during inflation is offset, thereby limiting the actual rotation of the artificial heart valve 300. The rotational force is small enough that the rotation of the artificial heart valve 300 is less than a threshold amount, to the extent that the balloon 174 applies some net rotational force to the artificial heart valve 300 when it inflates. As a result, the artificial heart valve 300 expands radially in response to the inflation of the balloon 174.

[0057] In some embodiments, the rotation of the prosthetic heart valve 300 relative to the internal catheter shaft 172 as a result of the balloon 174 inflating is less than a threshold rotation. In some examples, this threshold rotation is 10 degrees. For example, the difference between the rotational position of the prosthetic heart valve 300 before the balloon 174 is inflated while the prosthetic heart valve 300 is in a folded state and the rotational position of the prosthetic heart valve 300 after the prosthetic heart valve 300 is fully expanded may be less than a threshold rotation (e.g., 10 degrees). The threshold rotation is not limited to 10 degrees. In some examples, the threshold rotation may be any value within the range of 0 to 20 degrees (e.g., 1 degree, 2 degrees, 5 degrees, 15 degrees, or another value). In some examples, the prosthetic heart valve 300 does not rotate at all when transitioning from a folded state to an expanded state.

[0058] The balloon 174 expands the artificial heart valve 300 from a first diameter (D1) when the artificial heart valve 300 is folded to a second diameter (D2) when the artificial heart valve 300 is expanded. During this expansion, the inflation of the balloon 174 increases the diameter of the balloon, and consequently, the diameter of the artificial heart valve 300 also increases. As described above, when the balloon 174 is deflated, the balloon is pleated to fit into the lumen 176 of the folded artificial heart valve 300. When the balloon 174 is fully expanded, it is no longer pleated and folded, and has a round cross-section. During expansion, the folds in the balloon membrane unfold so that the balloon can expand to its full diameter. When the artificial heart valve 300 is expanded, the frame of the artificial heart valve 300 can engage with the annulus of the natural valve so that the artificial heart valve 300 is fixed to the target treatment site. This means that the artificial heart valve 300 can function in the same way as a healthy, natural valve, with blood flowing forward through the valve leaflets of the artificial heart valve and the leaflets blocking blood flow in the reverse direction.

[0059] The balloon catheter 170 and the controllable catheter 160 may be withdrawn from the target treatment site when the prosthetic heart valve 300 is in an expanded state and secured to the natural annulus. In some cases, the inflated balloon may be deflated via the flush line 124 before the balloon catheter 170 and the controllable catheter 160 are withdrawn. Once the balloon catheter 170 and the controllable catheter 160 are withdrawn, the prosthetic heart valve 300 may remain in an expanded state and secured to the natural annulus.

[0060] In the embodiment shown in Figure 7, the proximal end of the inflated balloon remains attached to the outer catheter shaft 173, and the distal end of the inflated balloon remains attached to the tapered nose cone 178. When inflated, the diameter of the balloon 174 increases from the proximal end distally until it reaches a maximum diameter D2. The central portion of the balloon has a diameter D2. The diameter decreases from D2 to a smaller diameter at the tapered nose cone 178 across the entire distal portion of the balloon 174. The folded prosthetic heart valve 300 is positioned on the central portion of the balloon 174, which achieves a diameter D2. This means that the diameter of the inflated prosthetic heart valve 300 is greater than or equal to D2.

[0061] Referring here to Figures 5-7, the artificial heart valve 300 includes several distinctive features that can function as reference markers when the artificial heart valve 300 is under visualization by medical imaging techniques. In some embodiments, the artificial heart valve 300 includes three commissures. For example, commissures 312 and 313 are shown in Figure 7. The artificial heart valve 300 also includes a third commissure, whose visibility is obstructed by balloon 174 in Figure 7. These three commissures correspond to the commissures of the innate aortic heart valve. In some embodiments, the commissures of the artificial heart valve 300 are visible under visualization both when the artificial heart valve 300 is in a folded state as shown in Figures 5-6 and when the artificial heart valve 300 is in an expanded state as shown in Figure 7. This means that a clinician operating the medical device delivery system 100 can align the artificial heart valve 300 with the natural aortic heart valve at the target site so that the commissure column of the artificial heart valve 300 aligns with the commissure of the natural aortic heart valve.

[0062] Aligning the commissure of the artificial heart valve 300 with the commissure of the natural heart valve can be achieved by rotating the balloon catheter 170 relative to the controllable catheter 160 until the commissure of the artificial heart valve 300 is aligned with the corresponding commissure of the natural heart valve. In embodiments in which the artificial heart valve 300 is attached to the rotating balloon catheter 170 when the balloon catheter 170 is in a folded state, the artificial heart valve 300 is rotated by rotating the balloon catheter 170 relative to the controllable catheter 160. Once the commissure of the artificial heart valve 300 is aligned with the commissure of the natural heart valve, the clinician can control the balloon 174 to inflate, and thus transition the artificial heart valve 300 from a folded state to an expanded state. When the artificial heart valve 300 transitions from a folded state to an expanded state, the commissure column of the artificial heart valve 300 remains aligned with the commissure of the natural heart valve because any rotation of the artificial heart valve 300 around the delivery shaft of the balloon catheter 170 during expansion does not exceed a threshold rotation amount.

[0063] In some cases, for the artificial heart valve 300 to be "aligned" with the natural heart valve, this involves the rotational position of the artificial heart valve 300 being less than a threshold rotational displacement from the rotational position of the natural heart valve. This threshold rotational displacement may be 10 degrees or another value. The displacement may occur in either direction (e.g., clockwise or counterclockwise), meaning that the range of acceptable rotational positions extends from a first rotational position in a first direction from the rotational position of the natural valve to a second rotational position in a second direction from the rotational position of the natural valve (e.g., an acceptable range from 10 degrees clockwise to 10 degrees counterclockwise of the natural valve).

[0064] If the commissure column of the artificial heart valve 300 is less than a threshold rotational distance from the commissure of the natural heart valve, or if the artificial heart valve leaflets of the artificial heart valve 300 are less than a threshold rotational distance from the leaflets of the natural valve, the artificial heart valve 300 is aligned with the natural heart valve. In some embodiments, a clinician can control the artificial heart valve 300 to be aligned with the natural heart valve within this acceptable range of rotational displacement, and the artificial heart valve 300 can remain within this acceptable range of rotational displacement as it transitions from a contracted state to an expanded state. The balloon 174 expands radially outward due to the linear cavity defined by the pleating of the balloon 174, which limits the rotational force applied to the artificial heart valve 300 by the balloon 174 during expansion.

[0065] The artificial heart valve 300 also includes a set of midpoint connectors, which are spaced around the outer circumference of the artificial heart valve 300 such that the midpoint connectors are located midway between each pair of consecutive commissure columns. For example, midpoint connector 314 is located midway between commissure columns 312 and 313. The artificial heart valve 300 includes two additional commissure columns that are hidden and not visible in Figure 7. These midpoint connectors can serve as reference markers when the balloon catheter 170 is under visualization during the delivery procedure. In some embodiments, each of the midpoint connectors defines a distinctive figure-eight pattern that is visible in medical images such as CT scans. This means that clinicians can identify the midpoint connectors against the anatomical features of the patient. The midpoint connectors correspond to the midpoints of each artificial leaflet attached to the frame of the artificial heart valve 300. This means that clinicians can align the artificial leaflets with the innate leaflets based on the position of the midpoint connectors in medical images. In some cases, the frame of the artificial heart valve 300 is fabricated from a fluoroscopic material so that the frame is visible under imaging from CT scans and / or other imaging modalities.

[0066] Figure 8A shows the distal end portion of the balloon catheter 170. As shown, the balloon catheter 170 includes an inner catheter shaft 172, an outer catheter shaft 173, a balloon 174, a tapered nose cone 178, and a valve stop member 190. One or more radiopaque markers 177A-177B (collectively, “radiopaque markers 177”) may be placed at various locations on the inner catheter shaft 172 and the valve stop member 190. In some embodiments, one or more of these radiopaque markers are visible under visualization as the balloon catheter 170 advances through the patient’s vascular system toward a target site (e.g., the site of the original aortic valve). In the embodiment of Figure 7, these radiopaque markers 177 are located on the portion of the balloon catheter 170 that is close to the artificial heart valve 300 or within the lumen 176 of the artificial heart valve 300 when the artificial heart valve 300 is in a folded state. This means that clinicians can determine the position of the artificial heart valve 300 relative to the patient's anatomical structure based on the position of the radiopaque marker 177 relative to the patient's anatomical structure as the balloon catheter 170 advances.

[0067] The radiopaque marker 177A is located between the proximal and distal ends of the prosthetic heart valve 300 when the prosthetic heart valve 300 is positioned on the balloon catheter 170. In some cases, the radiopaque marker 177A is located near the center of the prosthetic heart valve 300 when it is in an expanded state, as shown in Figure 7. In some cases, the radiopaque marker 177B is located close to the proximal end of the prosthetic heart valve 300 when it is in a folded state, as shown in Figure 6. This means that clinicians can determine the position of the prosthetic heart valve 300 based on the position of the radiopaque marker 177 relative to the patient's anatomical structure. The radiopaque marker 177 is not required to determine the position of the balloon catheter 170. In some cases, the clinician can determine the position of the balloon catheter 170 based on one or more reference markers located on the artificial heart valve 300 itself, such as commissure columns 312, 313 and midpoint connector 314.

[0068] Figure 8B shows the valve stop member 190 in isolation, thereby allowing further details of its structure to be seen. The valve stop member 190 includes a distal hub 191, an elongated proximal hub 192, and a frustoconical surface 194. The valve stop member 190 also includes a radiopaque marker 177A located on the surface of the valve stop member 190. This radiopaque marker 177A is located proximal to the frustoconical surface 194.

[0069] The distal hub 191 is attached to / adhered to the inner catheter shaft 172 so as to be held in place. However, the elongated proximal hub 192 is not attached to the inner catheter shaft 172 but is a polymer or metal tube that slides along the inner catheter shaft 172. More specifically, the elongated proximal hub 192 comprises an elongated tube that defines the lumen into which the inner catheter shaft 172 is slidably positioned. The elongated proximal hub 192 can slide along the inner catheter shaft 172. As will be further described below, during the assembly of the balloon catheter 170, the elongated proximal hub 192 is forced to slide along the inner catheter shaft 172, thereby longitudinally stretching the valve stop member 190, thereby reducing the outer diameter of the frustoconical surface 194, and as a result, the balloon 174 can be moved to a position on the valve stop member 190.

[0070] Figure 9A is a diagram showing an enlarged version of a broken section of the balloon catheter 170 at position X shown in Figure 4, this enlarged version showing one or more forces applied to the artificial heart valve 300 by the balloon 174. As seen in Figure 9A, the balloon 174 may be pleated, folded, and positioned to fit within the lumen 176 when the balloon 174 is in a deflated state. For example, the balloon 174 includes a first set of folds 322-328 and a second set of folds 342-348. Each of the first set of folds 322-328 is deflected in a first rotational direction (e.g., counterclockwise) with respect to the longitudinal axis of the balloon catheter 170 extending in and out of the page from the broken perspective view of Figure 9A. Each of the second set of folds 342-348 is deflected in a second rotational direction (e.g., clockwise) with respect to the longitudinal axis. For example, fold 322 is deflected counterclockwise according to deflection 323, and fold 346 is deflected clockwise according to deflection 347.

[0071] Folds 322 and 346 are deflected or wound to extend in opposite directions (i.e., fold 322 is deflected counterclockwise and fold 346 is deflected clockwise) so that the deflated balloon 174 can fit into the lumen 176 of the folded artificial heart valve 300. Thus, folds 322 and 346 apply opposite rotational forces to the inner surface of the artificial heart valve 300 as it transitions from a folded state to an expanded state. As shown in Figure 9A, fold 322 can apply a first force to the artificial heart valve 300 having a radial component 362 and a tangential component 364, and fold 346 can apply a second force to the artificial heart valve 300 having a radial component 366 and a tangential component 368. The tangential components 364 and 368 of these forces alone constitute a rotational force that rotates the artificial heart valve 300 without resistance. However, as can be seen in Figure 9A, the tangential component 364 of the first force applied by fold 322 and the tangential component 368 of the second force applied by fold 346 are applied in opposite directions, meaning that these components substantially cancel each other out. The radial components 362 and 366 are both directed outward, meaning that the radial components 362 and 366 work together to expand the artificial heart valve 300 radially outward. The net result of the combined radial force components and the canceling tangential force components is that the artificial heart valve 300 expands radially outward without substantially rotating around the longitudinal axis of the balloon catheter 170.

[0072] Folds 322 and 346 thus form opposing pairs of deflected folds. The exemplary arrangement of the balloon 174 shown in Figure 9A includes three other opposing pairs of deflected folds, each working together to combine the radial force applied to the artificial heart valve 300 and counteract the tangential force. Folds 326 and 342 form another pair of such opposing deflected folds, with fold 326 deflected counterclockwise and fold 342 deflected clockwise. As a result, fold 326 applies a third force including a radial component 372 and a tangential component 374, and fold 328 applies a fourth force including a radial component 376 and a tangential component 378. Similar to the pair of folds 322 and 346, the pair including folds 326 and 342 applies opposite tangential forces to the artificial heart valve 300 (i.e., tangential components 374 and 378 are in opposite directions) and complementary radial forces (i.e., radial components 372 and 376 are both directed outwards). This means that folds 326 and 342, much like folds 322 and 346, form a pair of opposing deflected folds that promote radial expansion of the artificial heart valve 300 while restricting rotation of the artificial heart valve 300 around its longitudinal axis. Folds 324 and 348 are two more pairs of opposing deflected folds that also promote radial expansion while restricting rotation.

[0073] Overall, the forces applied by the first set of folds 322-328 and the second set of folds 342-348 as the balloon 174 expands from a deflated state to an inflated state include a net outward radial force that increases the diameter of the prosthetic heart valve 300. This force is limited to the extent that the first set of folds 322-328 and the second set of folds 342-348 apply a net rotational force to the prosthetic heart valve 300, so that the rotation of the prosthetic heart valve 300 during expansion is restricted to less than a threshold rotation (e.g., less than 10 degrees). Since the first set of folds 322-328 is deflected in a first rotational direction and the second set of folds 342-348 is deflected in a second rotational direction, this means that the collective tangential force applied by the first set of folds 322-328 is substantially equal to the collective tangential force applied by the second set of folds 342-348 during expansion. Even if the tangential forces applied by the first set of folds 322-328 and the tangential forces applied by the second set of folds 342-348 do not completely cancel each other out, the net tangential force can be small enough that any resulting rotation of the artificial heart valve 300 is less than a threshold rotation.

[0074] Figure 9B shows a perspective view of a fractured section of a balloon 174 positioned according to the pattern shown in Figure 9A to fit within the lumen of a folded artificial heart valve 300. As seen in Figure 9B, the balloon 174 is positioned with multiple folds deflected so that the balloon 174 fits within a diameter significantly smaller than the diameter of the balloon 174 when fully expanded. The balloon 174 extends along the longitudinal axis of the balloon catheter 170, and the folds extend along the longitudinal axis of the balloon catheter 170. This means that the fracture shown in Figure 9A exhibits the pattern of the balloon 174 present in the fractured section along a substantial portion of the balloon 174. Opposing pairs of folds 322, 346 and folds 326, 242 are shown in Figure 9B. Other pairs of folds are also present in the example in Figure 9B.

[0075] This disclosure is not limited to the patterns shown in Figures 4 and 9A-9B. When deflated, the balloon 174 can form one or more other patterns that expand the artificial heart valve 300 while restricting its rotation. For example, one or more other patterns may include folds that apply opposite tangential forces to the artificial heart valve 300 during expansion in order to restrict its rotation.

[0076] Figure 10 shows the rupture locations 210-224 of the balloon 174, which is in a deflated and compressed state and positioned within the lumen of the artificial heart valve 300. Rupture location 210 is the most distal rupture location, rupture location 224 is the most proximal rupture location, and rupture locations 212-222 are located between rupture locations 210 and 224. Each rupture location corresponds to the respective cross-section shown in Figures 10-18, as will be described in more detail below. For example, rupture location 210 corresponds to Figure 11, rupture location 212 corresponds to Figure 12, rupture location 214 corresponds to Figure 13, rupture location 216 corresponds to Figure 14, rupture location 218 corresponds to Figure 15, rupture location 220 corresponds to Figure 16, rupture location 222 corresponds to Figure 17, and rupture location 224 corresponds to Figure 18.

[0077] Figures 11 to 18 show cross-sectional views of the balloon 174 in a contracted state, compressed and positioned within the lumen of the artificial heart valve 300 at each of the rupture positions 210 to 224 in Figure 10. The arrangement of the balloon 174 in the embodiments shown in Figures 11 to 18 differs from the arrangement of the balloon 174 in the embodiments shown in Figures 4 and 9A to 9B. For example, Figure 11 shows a fracture diagram 211 of balloon 174 corresponding to fracture position 210, Figure 12 shows a fracture diagram 213 corresponding to fracture position 212, Figure 13 shows a fracture diagram 215 corresponding to fracture position 214, Figure 14 shows a fracture diagram 217 corresponding to fracture position 216, Figure 15 shows a fracture diagram 219 corresponding to fracture position 218, Figure 16 shows a fracture diagram 221 corresponding to fracture position 220, Figure 17 shows a fracture diagram 223 corresponding to fracture position 222, and Figure 18 shows a fracture diagram 225 corresponding to fracture position 224.

[0078] The fracture diagram 211 in Figure 11 shows, for example, that balloon 174 forms a clover-shaped pattern at the most distal fracture site 210. Balloon 174 does not form any folds in fracture diagram 211. As shown in Figure 7, the maximum diameter of balloon 174 at the distal end is smaller than the maximum diameter of balloon 174 in the middle portion of balloon 174. This means that balloon 174 does not have as much membrane material that fits into the lumen of the artificial heart valve 300 at fracture site 210 as it does in the fracture diagram of the middle portion of balloon 174. The same is true for fracture diagram 225 in Figure 18, which corresponds to the most proximal fracture site 224 in Figure 10. In fracture diagram 225, balloon 174 forms a clover-shaped pattern very similar to the clover-shaped pattern of balloon 174 in fracture diagram 211, which corresponds to the most distal fracture location 210.

[0079] Fracture diagrams 213-223 correspond to fracture positions 212-222, which are located between the most distal fracture position 210 and the most proximal fracture position 224. These fracture diagrams 213-223 show that the balloon 174 is pleated and folded such that the membrane of the balloon 174 forms several folds that define a recess extending over a substantial portion of the length of the balloon 174. For example, the open recess 384 is visible in each of the fracture diagrams 213-223 and is defined by folds in the balloon 174 that curve away from each other. The open recess 384 is substantially linear and extends parallel to the longitudinal axes of the inner catheter shaft 172 and the balloon 174. Because the open recess 384 is linear, it extends parallel to the inner catheter shaft 172. Furthermore, the open recess 386 is formed by two folds that curve away from each other and outward, forming an open channel. The open recess 386 is substantially linear and extends parallel to the longitudinal axes of the inner catheter shaft 172 and the balloon 174. Because the open recess 386 is linear, it extends parallel to the inner catheter shaft 172.

[0080] Cross-sectional diagrams 213-223 show several other open and closed recesses. Each of these recesses is linear and extends parallel to the longitudinal axis of the inner catheter shaft 172 and balloon 174. This means that when balloon 174 is pleated and folded to fit into the lumen of the artificial heart valve 300 in a compressed state, balloon 174 is pleated and folded to form a linear recess following a point on the outer circumference of the inner catheter shaft 172. For example, open recess 384 forms a depression, the bottom of which extends substantially linearly. Since open recess 384 is linear, this depression expands radially outward in a direction substantially perpendicular to the tangent of balloon 174, and not in the rotational direction. Open recess 386 forms an open channel. During expansion, the fold defining the open recess 386 extends outward, and the bottom of the closed channel expands radially in a direction substantially perpendicular to the tangent to the balloon 174, but not in a rotational direction.

[0081] Figure 19 shows a pleating tool 400 for pleating a balloon 402 to fit into a recess of an artificial heart valve in a folded state. The pleating tool 400 is configured to pleat the balloon 402 such that the membrane of the balloon 402 forms a linear recess extending along the longitudinal axis of the balloon. As seen in Figure 19, the pleating tool 400 includes a mandrel 404. The pleating tool 400 also includes pleating heads 412A to 412D (collectively, “pleating heads 412”). Each pleating head of pleating heads 412 corresponds to a pleating tooth of pleating teeth 414A to 414D (collectively, “pleating teeth 414”). The pleating tool 400 also includes folding heads 418A to 418D (collectively, “folding heads 418”).

[0082] As shown in Figure 19, the pleating head 412, pleating teeth 414, and folding head 418 are each positioned to extend radially along an axis intersecting the central axis of the pleating tool 400. The mandrel 404 extends along the central axis of the pleating tool 400. In some examples, the pleating head 412, pleating teeth 414, and folding head 418 are configured to move radially inward toward the mandrel 404 and outward toward the mandrel 404. For example, the pleating head 412 and pleating teeth 414 are configured to move radially inward in response to the clockwise rotation of the arm 422 and radially outward in response to the counterclockwise rotation of the arm 422. The folding head 418 is configured to move radially inward in response to the clockwise rotation of the arm 424 and to move radially outward in response to the counterclockwise rotation of the arm 424.

[0083] The pleating teeth 414 are detachably attached to the pleating head 412. For example, pleating teeth 414A are detachably attached to the pleating head 412A, pleating teeth 414B are detachably attached to the pleating head 412B, pleating teeth 414C are detachably attached to the pleating head 412C, and pleating teeth 414D are detachably attached to the pleating head 412D. The balloon 402 is attached to the mandrel 404 at the center of the pleating tool 400. As seen in Figure 19, the balloon 402 is in an inflated or semi-inflated state and has not yet been pleated, so the cross-section of the balloon 402 is round. As the pleating teeth 414 and the pleating head 412 and / or the folding head 418 move inward, this deforms the membrane of the balloon 402, and as a result the cross-section is no longer round. If balloon 402 is round and pleating has not yet been performed, this is the "first pleating position" of the pleating tool 400.

[0084] Figure 20 shows a pleating tool 400 for pleating a balloon 402 in a second pleating position where the pleating head 412 and pleating teeth 414 extend inward to create a set of cavities. For example, the pleating head 412A and pleating teeth 414A can extend radially inward to create a first cavity on the upper side of the balloon 402, the pleating head 412B and pleating teeth 414B can extend radially inward to create a second cavity on the right side of the balloon 402, the pleating head 412C and pleating teeth 414C can extend radially inward to create a third cavity on the bottom side of the balloon 402, and the pleating head 412D and pleating teeth 414D can extend radially inward to create a first cavity on the left side of the balloon 402. As shown in Figure 20, the cross-section of the balloon 402 forms a cloverleaf pattern at the second pleating position of the pleating tool 400, and this cloverleaf pattern includes four bulges in the membrane of the balloon 402. Each of the four bulges is located between two consecutive pleating heads of the pleating head 412. The pleating tool 400 can be moved to the second pleating position in Figure 12 based on the clockwise rotation of the arm 422 in Figure 19, thereby advancing the pleating head 412 and the pleating teeth 414 inward.

[0085] Figure 21 shows a pleating tool 400 for pleating the balloon 402 in a third pleating position in which the pleating head 412 is retracted, the pleating teeth 414 secure a cavity within the balloon 402, and the pleating nut 432 is attached to fix the pleating teeth 414 in place. For example, the pleating nut 432 can be fitted onto the pleating teeth 414 so that the pleating teeth 414 are fixed to the pleating nut 432 and the pleating teeth 414 can be freely disengaged from the pleating head 412. For example, the pleating nut 432 can fix the pleating teeth 414 in place so that the cloverleaf pattern and cavity of the balloon 402 are secured even when the pleating head 412 disengages from the pleating teeth 414 and retracts. This means that the pleating nut 432 can fix the pleating teeth 414 in place without fixing the pleating head 412 in place.

[0086] Figure 22 shows a pleating tool 400 for pleating the balloon 402 in a fourth pleating position in which the pleating head 412 is retracted and the pleating teeth 414 are secured by a pleating nut 432, thereby securing a cavity within the balloon 402. In some examples, following a second pleating position shown in Figure 20 in which the pleating head 412 and pleating teeth 414 advance to create a cavity within the balloon 402, a pleating nut 432 is placed on the pleating tool 400 so that the pleating teeth 414 can be secured in place. Once the pleating nut 432 secures the pleating teeth 414, the pleating head 412 retracts radially in response to the counterclockwise rotation of the arm 422, leaving the pleating teeth 414 in place and securing the cavity within the balloon 402. As shown in Figure 21, the balloon 402 maintains a clover-shaped pattern, secured by the pleating nut 432 and pleating teeth 414, when the pleating head 412 retracts. As shown in Figure 21, in the second pleating position, the pleating head 412 is separated from the pleating teeth. In some examples, the pleating head 412 retracts, allowing the folding head 418 to advance inward without being obstructed by the pleating head 412.

[0087] Figure 23 shows the pleating tool 400 for pleating balloon 402 at a fifth pleating position where the folding head 418 is advanced and creates folds in the membrane of balloon 402. For example, the folding head 418 can be advanced in response to the counterclockwise rotation of the arm 424 shown in Figure 19. The folding head 418 can be advanced radially inward and can compress the cloverleaf pattern of bulges of balloon 402 present at the fourth pleating position. As seen in Figure 23, when the folding head 418 is advanced, the membrane of the balloon itself is folded at several positions, which are referred to herein as “folds” of balloon 402. These folds can be further manipulated to reduce the radius of balloon 402 when deflated. The folding head 418 forms recesses in the balloon membrane. These recesses are linear, meaning that the recesses extend along the balloon substantially parallel to the longitudinal axis of the balloon.

[0088] Figure 24 shows a pleating tool 400 for pleating balloon 402 in a sixth pleating position where the pleating head 412 and the folding head 418 are retracted and the folds in the membrane of balloon 402 are secured by vacuum. For example, the pleating tool 400 can vacuum-suction air and / or liquid from balloon 402 so that the shape of balloon 402 is maintained. This allows the folding head 418 to retract while balloon 402 retains the same shape with folds. In some examples, the folding head 418 retracts in response to the clockwise movement of arm 424 shown in Figure 19. Once the folding head 418 is retracted, the pleating nut 434 can be removed. At this point, the folds of balloon 174 may be further positioned to form open and closed cavities so that balloon 174 fits into the lumen of the artificial heart valve 300 while balloon 174 is in the folded position. In other words, the same number of folded portions of balloon 402 can be wound so that they extend in opposite directions around the longitudinal axis of balloon 402 (for example, the first four folded portions can be wound clockwise, and the remaining four folded portions can be wound counterclockwise).

[0089] Figure 25 is a flowchart illustrating an exemplary procedure for inflating a balloon catheter containing a pleated balloon with a linear recess. Figure 25 is illustrated with respect to the medical device delivery system 100 of Figures 1 to 7. However, the technique of Figure 25 may be performed by different components of the medical device delivery system 100, or by additional or alternative medical device systems.

[0090] The balloon 127 may be attached to the delivery shaft such that the membrane of the balloon 127 defines several folds extending along the longitudinal axis of the delivery shaft (502). In some examples, the balloon 174 may be attached to any part of the delivery shaft of the balloon catheter 170, including a tapered nose cone 178, an inner catheter shaft 172, an outer catheter shaft 173, a valve stop member 190, or any combination thereof. In some examples, the distal end of the balloon 174 is attached to the tapered nose cone 178, and the proximal end of the balloon 174 is attached to the outer catheter shaft 173. The outer catheter shaft 173 may be slidably received by the lumen of a maneuverable catheter 160 located proximal to the balloon catheter 170. This means that the balloon catheter 170 is configured to slide distally away from the maneuverable catheter 160 or to move distally toward the maneuverable catheter 160. In some examples, the multiple folds of balloon 174 may include a first set of folds deflected in a first direction and a second set of folds deflected in a second direction. In some examples, the first set of folds may include four folds, and the second set of folds may include four folds.

[0091] Multiple folds are created when the membrane material flaps themselves fold, resulting in the membrane material having a thickness of two layers along with the transitional portion where the material folds. These folds may be positioned to occupy a small area so that the balloon 174 can fit into a lumen having a diameter significantly smaller than the diameter of the balloon 174 when inflated. For example, the folds of the deflated balloon 174 may be positioned to form one or more open recesses and one or more closed recesses. Each of the one or more closed recesses may be defined by overlapping folds in the membrane of the balloon 174. Each of the one or more open recesses may be formed by folds in the membrane of the balloon 174 that extend apart from each other to create a depression. Both the open and closed recesses extend parallel to the delivery shaft and parallel to the longitudinal axis of the balloon catheter 170.

[0092] In some embodiments, the artificial heart valve 300 is positioned on a balloon 174 fixedly attached to the delivery shaft of a balloon catheter 170 (504). The artificial heart valve 300 can be in a folded state while the deflated balloon 174 is positioned within a lumen defined by the folded artificial heart valve 300. The balloon 174 can be pleated in the deflated state to occupy a cross-section with a significantly smaller diameter than the balloon 174 when inflated, so that the balloon 174 can fit into the lumen defined by the folded artificial heart valve 300. The artificial heart valve 300 can be secured in place by a valve stop member 190 and the flared distal end 162 of a maneuverable catheter 160. This allows the balloon catheter 170 to be advanced toward the target treatment side (e.g., the natural aortic valve) with the artificial heart valve 300 secured to the balloon catheter 170, the artificial heart valve 300 in the folded state, and the balloon 174 in the deflated state.

[0093] The balloon 187 inflates, allowing the prosthetic heart valve 300 to transition from a folded state to an expanded state such that the rotation of the prosthetic heart valve 300 around the longitudinal axis of the delivery shaft is less than a threshold rotation (508). This allows the clinician to align the prosthetic heart valve 300 with the innate valve while it is compressed, so that the prosthetic heart valve 300 remains aligned with the prosthetic heart valve 300 when expanded. In some embodiments, folds deflected in opposite directions facilitate radial expansion of the prosthetic heart valve 300 without rotation, as the tangential forces applied by the folds deflected in opposite directions cancel each other out.

[0094] This specification includes many specific implementation details, which should not be interpreted as limiting the scope of any invention or the scope of the claimed subject matter, but rather as descriptions of features that may be specific to a particular embodiment of a particular invention. Certain features described herein in relation to separate embodiments may also be implemented in combination in one embodiment. Conversely, various features described in the context of one embodiment may also be implemented separately in multiple embodiments or in any preferred partial combination. Furthermore, even if features are described herein as acting in a particular combination and are initially claimed as such, one or more features from the claimed combination may, in some cases, be removed from the combination, and the claimed combination may cover a partial combination or a variation of a partial combination.

[0095] Similarly, while operations are shown in a specific order in the diagrams, this should not be understood as requiring that such operations be performed in a specific or sequential order, or that all illustrated operations be performed, in order to achieve the desired result. In certain situations, multitasking and parallel processing may be advantageous.

[0096] A specific embodiment of the subject matter has been described. Other implementations are also within the scope of the following claims. For example, the desired results can still be achieved even if the actions listed in the claims are performed in a different order. As an example, the process depicted in the accompanying drawings does not necessarily require the specific order or sequence shown to achieve the desired results.

Claims

1. A balloon catheter system for delivering an artificial heart valve to a target site in the patient's natural valve, Delivery shaft and A balloon fixedly attached to the delivery shaft, wherein when the balloon is in a deflated state, the membrane material of the balloon defines a plurality of folded portions extending along the longitudinal axis of the delivery shaft, An artificial heart valve placed on the balloon when the balloon is in the deflated state and the artificial heart valve is in the folded state, wherein a first set of the folded portions of the plurality of folded portions extends clockwise around the longitudinal axis of the delivery shaft, and a second set of the folded portions of the plurality of folded portions extends counterclockwise around the longitudinal axis of the delivery shaft, and A balloon catheter system equipped with [the following features].

2. The balloon catheter according to claim 1, wherein when the balloon transitions from the deflated state to the inflated state, the first set of folded portions expands outward with respect to the longitudinal axis and counterclockwise around the longitudinal axis, and the second set of folded portions expands outward with respect to the longitudinal axis and clockwise around the longitudinal axis, thereby transitioning the artificial heart valve from the folded state to the inflated state.

3. The balloon catheter according to claim 2, wherein when the first set of folded portions expands counterclockwise around the longitudinal axis and the second set of folded portions expands clockwise around the longitudinal axis, the first set of folded portions applies a first rotational force to the artificial heart valve and the second set of folded portions applies a second rotational force to the artificial heart valve opposite to the first rotational force.

4. The balloon catheter system according to claim 2, wherein the rotation of the artificial heart valve relative to the delivery shaft in response to the artificial heart valve transitioning from the folded state to the expanded state is less than a threshold rotation amount.

5. The balloon catheter system according to claim 4, wherein the threshold rotation amount is 10 degrees.

6. The delivery shaft is configured to advance to the target site when the balloon is in the deflated state and the artificial heart valve is in the folded state, such that each artificial valve leaflet of the set of artificial valve leaflets attached to the artificial heart valve aligns with the corresponding natural valve leaflet of the natural valve. The balloon catheter system according to claim 2, wherein, in response to the balloon transitioning from the deflated state to the inflated state, the artificial heart valve expands from the folded state to the expanded state, such that when the artificial heart valve is in the expanded state, each artificial valve leaflet of the set of artificial valve leaflets remains aligned with the corresponding natural valve leaflet of the natural valve.

7. The balloon catheter system according to claim 6, wherein the delivery shaft and the balloon are configured to allow the artificial heart valve to be withdrawn from the target site while the artificial heart valve remains in the expanded state, with each artificial heart valve leaflet of the set of artificial heart valve leaflets remaining aligned with the corresponding natural valve leaflet of the natural valve.

8. The balloon catheter system according to claim 1, wherein the first set of the folded portions and the second set of the folded portions define a plurality of recesses, and each of the plurality of recesses extends along the longitudinal axis of the delivery shaft.

9. The plurality of recesses, One or more enclosed recesses, each enclosed recess of the one or more enclosed recesses being defined by one folded portion of a first set of folded portions deflected toward each other and one folded portion of a second set of folded portions, One or more open recesses, each of the one or more open recesses being defined by one folded portion of a first set of folded portions and one folded portion of a second set of folded portions which are deflected apart from each other, and The balloon catheter system according to claim 8, comprising:

10. The plurality of folded portions comprises one or more pairs of folded portions, and each pair of folded portions of the one or more pairs of folded portions is One folded portion of the first set of folded portions extends clockwise around the longitudinal axis of the delivery shaft, One folded portion of the second set of folded portions extends counterclockwise around the longitudinal axis of the delivery shaft and The balloon catheter system according to claim 1, comprising:

11. The balloon catheter system according to claim 1, wherein the plurality of folded portions comprises eight folded portions, a first set of the folded portions comprises four folded portions, and a second set of the folded portions comprises four folded portions.

12. The delivery shaft is configured to advance to the target site when the balloon is in the deflated state and the artificial heart valve is in the folded state. The artificial heart valve in the folded state is configured to rotate about the longitudinal axis of the delivery shaft, The balloon catheter system according to claim 1, wherein, based on the fact that the artificial heart valve in the folded state is within a desired rotational position range relative to the patient's natural valve, the balloon is configured to inflate so as to move the artificial heart valve from the folded state to the expanded state, and the artificial heart valve in the expanded state remains within the desired rotational position range relative to the patient's natural valve.

13. The balloon catheter system according to claim 12, wherein the desired rotational position range with respect to the patient's innate valve includes a target rotational position, and the desired rotational position range extends from a first rotational position displaced counterclockwise from the target rotational position to a second rotational position displaced clockwise from the target rotational position.

14. The balloon catheter system according to claim 13, wherein the first rotation position is displaced 10 degrees counterclockwise from the target rotation position, and the second rotation position is displaced 10 degrees clockwise from the target rotation position.

15. The aforementioned artificial heart valve A frame configured to expand from the folded state to the expanded state in response to the balloon transitioning from the contracted state to the expanded state, The set of artificial heart valve leaflets attached to the expandable frame and The balloon catheter system according to claim 1, comprising, wherein when the membrane material of the balloon expands radially outward relative to the delivery shaft, the balloon applies a radial force to the inner surface of the frame such that the frame expands radially outward relative to the delivery shaft from the folded state to the expanded state.

16. A balloon catheter for delivering an artificial heart valve to a target site in the patient's natural valve, Delivery shaft and A balloon fixedly attached to the delivery shaft, wherein when the balloon is in a deflated state, the membrane material of the balloon defines a plurality of folded portions extending along the longitudinal axis of the delivery shaft, and Equipped with, A balloon catheter in which, when the balloon is in the deflated state and the artificial heart valve is in the folded state, and the balloon is placed inside the artificial heart valve, a first set of the folded portions of the plurality of folded portions extends clockwise around the longitudinal axis of the delivery shaft, and a second set of the folded portions of the plurality of folded portions extends counterclockwise around the longitudinal axis of the delivery shaft.

17. The balloon catheter according to claim 16, wherein the first set of folded portions and the second set of folded portions define a plurality of recesses, and each of the plurality of recesses extends along the longitudinal axis of the delivery shaft.

18. The plurality of recesses, One or more enclosed recesses, each enclosed recess of the one or more enclosed recesses being defined by one folded portion of a first set of folded portions deflected toward each other and one folded portion of a second set of folded portions, One or more open recesses, each of the one or more open recesses being defined by one folded portion of a first set of folded portions and one folded portion of a second set of folded portions which are deflected apart from each other, and The balloon catheter according to claim 17, comprising:

19. The plurality of folded portions comprises one or more pairs of folded portions, and each pair of folded portions of the one or more pairs of folded portions is One folded portion of the first set of folded portions of the delivery shaft which is deflected clockwise around the longitudinal axis of the delivery shaft, One of the second set of folded portions of the folded portions of the delivery shaft which are deflected counterclockwise around the longitudinal axis of the delivery shaft and A balloon catheter according to claim 18, comprising:

20. A method for forming pleats in a balloon attached to a delivery shaft, Inflating the balloon such that its cross-section is substantially circular, Moving a set of pleating heads radially outward, wherein each pleating head in the set of pleating heads pushes the balloon membrane material inward, defining one of the recesses in the set of recesses, and each pleating head is equipped with a pleating tooth located at the distal end of each pleating head. To fix the pleating teeth of each pleating head, a pleating nut is installed, and the set of the recesses is ensured. The set of pleating heads is moved radially outward, and the pleating teeth corresponding to each pleating head remain fixed to the pleating nut. Moving the set of folding heads radially inward, wherein each folding head of the set of folding heads pushes the membrane material of the balloon inward, defining a plurality of folded portions. The arrangement of the multiple folded portions is such that a first set of the multiple folded portions extends clockwise around the longitudinal axis of the delivery shaft, and a second set of the multiple folded portions extends counterclockwise around the longitudinal axis of the delivery shaft. A method that includes this.

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