POWERED IMPLANT DELIVERY DEVICE, IMPLANTS, LOADING SYSTEMS, AND METHODS OF USE - Patent application

Abstract

A heart valve implantation device having a motor and drive mechanism that allows a single operator to deliver a prosthetic heart valve to a target site. The motor controls the relative position between a delivery catheter and an implant release mechanism attached to the implant. The motor can operate in two directions, allowing the motor to be used not only for delivery, but also for loading and extraction of the valve, as needed. Also described are embodiments of a loading system designed for use with the valve implants and devices.

Description

[Technical field]

[0001] There has been considerable movement toward the development and performance of cardiovascular procedures using percutaneous approaches. For example, through the use of one or more catheters introduced through the femoral artery, tools and devices can be delivered to desired regions of the cardiovascular system to perform any number of complex procedures that would otherwise normally require invasive surgical procedures. Such approaches can significantly reduce the trauma to which patients are exposed and significantly reduce recovery periods. Percutaneous approaches are particularly attractive as an alternative to performing open-heart surgery. [Background technology]

[0002] Valve replacement surgery provides one example of an area in which percutaneous solutions are being developed. Several diseases result in thickening of the cardiac valve leaflets and subsequent immobility or reduced mobility. Such immobility can also result in narrowing or stenosis of the passageway through the valve. The increased resistance to blood flow presented by a stenosed valve can eventually lead to heart failure and ultimately death.

[0003] Treatment of valvular stenosis or regurgitation traditionally involves the complete removal of the existing native valve through an open-heart procedure followed by the implantation of a prosthetic valve. Naturally, this is a highly invasive procedure, which causes significant trauma to the body and usually results in significant discomfort and significant recovery time. It is also a complex procedure that requires great expertise and competence to perform.

[0004] Historically, such valve replacement procedures are performed using traditional open-heart surgery, where the chest is opened, the heart is stopped, the patient is put on cardiopulmonary bypass, the native valve is removed, and a replacement valve is installed. Meanwhile, a proposed percutaneous valve replacement alternative is disclosed in U.S. Patent No. 6,168,614 issued to Andersen et al., the entire contents of which are incorporated herein by reference. In this patent, a prosthetic valve is mounted on a stent that is collapsed to a size that fits within a catheter. The catheter is then inserted into the patient's vasculature and moved to position the collapsed stent at the location of the native valve. A deployment mechanism is activated that expands the stent, including the replacement valve, against the leaflets. The expanded configuration includes a stent configured to have a valve shape, and the leaflet supports begin to assume the functions of the native valve. As a result, complete valve replacement is achieved, but with significantly reduced physical effects on the patient.

[0005] However, this approach has clear drawbacks. One particular drawback of the percutaneous approach disclosed in Andersen '614 is the difficulty in preventing leakage around the periphery of the new valve after implantation. Because the native valve tissue remains within the lumen, the commissural junctions and fusion points of the valve tissue (as it is pushed apart and secured by the stent) are likely to make it difficult to seal around the prosthetic valve. In practice, this has often resulted in severe leakage of blood around the stent device.

[0006] Other drawbacks of the Andersen '614 approach relate to the reliance on stents as a supporting scaffold for the prosthetic valve. First, stents may form emboli upon expansion. Second, stents are typically not effective at trapping emboli, which become dislodged either during or after deployment. Third, stents typically do not conform to the characteristics of the native lumen in which they are placed, making prosthetic valves housed within stents prone to perivalvular leakage. Fourth, stents suffer from a trade-off between strength and compressibility. Fifth, stents cannot be retrieved once deployed. Sixth, stents have an inherent strength that is not adjustable.

[0007] Regarding the first drawback, stents are typically classified into one of two categories: self-expanding stents and balloon-expandable stents. Self-expanding stents are compressed when loaded onto a catheter and expand to their original uncompressed size when released from the catheter. They are typically made of Nitinol. Balloon-expandable stents are loaded onto a catheter in a compressed but relaxed state. They are typically made of stainless steel or other malleable metals. A balloon is placed within the stent. During deployment, the catheter is retracted and the balloon is inflated, thereby expanding the stent to the desired size. Both of these stent types exhibit significant force upon expansion. The force is usually strong enough to break up or deform the thrombus, thereby dislodging pieces of atherosclerotic plaque and becoming emboli. If the stent is being implanted to treat a narrowed blood vessel, some degree of such expansion is desirable. However, if the stent is being implanted simply to replace a natural valve, less force may be desirable to reduce the likelihood of creating an embolus. An additional concern with aortic valve replacement is the risk of conduction disturbances (i.e., left bundle branch block) due to the proximity of the conduction pathways to the native valve structure. Excessive radial forces applied at the native valve site increase the risk of irritation or damage to the conduction pathways and heart block.

[0008] Regarding the second drawback, if an embolism is created, the expanded stent usually has members that are too far apart to be effective in capturing any dislodged material, and secondary precautions must often be taken, including the use of nets and irrigation ports.

[0009] A third drawback results from the relative inflexibility of stents. Stents typically rely on the elastic properties of the native vessel to fit around the stent. Stents used to open narrowed, blocked vessels do not require a seal between the vessel and the stent. However, when a stent is used to replace a native valve and house a prosthetic valve, a seal between the stent and the vessel is necessary to prevent paravalvular leakage. Due to the incompatibility of the stent, this seal is difficult to achieve, especially when replacing stenosed valve leaflets.

[0010] A fourth drawback is the trade-off between compressibility and strength. Stents are made stronger or larger by manufacturing them with thicker members. Thus, stronger stents are not as compressible as weaker stents. Most stents suitable for use in valves are not compressible enough to be placed in thin catheters, such as 18Fr catheters. Larger delivery catheters are more difficult to maneuver to the target area and result in more trauma to the patient.

[0011] A fifth drawback of stents is that they are not easily retrievable. Once deployed, a stent may not be able to be recompressed and pulled back into the catheter for repositioning due to inelastic deformation (stainless steel) or the radial force required to keep the stent in place (nitinol). Thus, if a physician is unhappy with the location or orientation of a stent deployment, there is little that can be done to correct the problem.

[0012] The sixth drawback listed above is that stents have an inherent strength and are therefore not adjustable. As previously mentioned, stronger stents are made of stronger materials. Once a stent is selected and deployed, there is little a physician can do if the stent proves to be too strong or too weak.

[0013] Various embodiments of devices that solve these problems are found in the Thill et al. family of patents entitled "Stentless Support Structure," including U.S. Patent Nos. 8,974,523, 9,271,831, 9,180,002, 9,439,761, 9,168,132, and 9,439,760, as well as numerous pending and foreign applications and patents, the contents of which are incorporated herein in their entirety. These patents teach a braided mesh tube that has the ability to fold back and forth and build itself in situ into a support structure that is strong enough to adequately hold the leaflets of the native valve and successfully deploy a replacement valve, thus eliminating the need for resection of the native valve. Advantageously, because of the invertibility of these devices, the braided mesh in the elongated delivery configuration does not need to have the strength to achieve replacement of the native valve until the inversion process occurs. This allows the mesh tube to be configured such that in an elongated delivery state, the tube can be compressed into a very small catheter, such as an 18Fr or smaller catheter. Such a small catheter significantly reduces trauma to the patient and allows for easy percutaneous intraluminal navigation through the blood vessel. Of course, as used herein, terms such as transluminal and percutaneous are explicitly defined as navigation axially through the lumen of a blood vessel or vessels to a target location, rather than surgically opening the target vessel or heart and manually placing a device. It should be further understood that as used herein, the term "mesh" describes a material constructed from one or more braided or woven strands.

[0014] To achieve the forward and backward folding feature of the device, the device has preformed circumferential folds. One embodiment has two circumferential folds spaced longitudinally apart in the expanded configuration. One of the folds is preformed to fold inward and the other is preformed to fold outward. These preformed folds tend to return to a folded configuration having a z-like cross section when released from the catheter. This cross-sectional design results not only because the inward preformed folds fold inward and the outward preformed folds fold outward, but also because the longitudinal positions of these folds are reversed when folded. If the inward preformed fold is distal to the outward preformed fold in the expanded position, then in the folded position the inward preformed fold is proximal to the outward preformed fold. This design allows the valve on the distal end of the device to be pulled into the device when folded without having to invert or turn the valve itself inside out. Thus, in one embodiment having two preformed creases, the inversion process results in a three-layer configuration that may be significantly shorter than the expanded length, depending on the spacing of the creases.

[0015] A delivery device was developed specifically for the delivery of such implants. An early iteration of this delivery device is shown and described at least in U.S. Patent No. 9,795,478 to Wilson et al., entitled "Inversion Delivery Device and Method for a Prosthesis," the contents of which are incorporated herein by reference. This delivery device included multiple control cables that allowed the physician to control the rate at which the implant was expelled from the distal end of the device and also allowed for proper movement of the implanted valve before the implant was fully released. If the physician was not satisfied with the positioning of the implant, the cables could be used to pull the valve back into the delivery catheter and reposition the valve at the desired site.

[0016] However, these devices included several different knobs and buttons and, as a result, took time to learn how to use them properly. Additionally, the physician relied on tactile feedback in combination with visual fluoroscopic feedback to determine the timing of various steps in the procedure.

[0017] To address these concerns, a next generation delivery device was developed. This delivery device is shown and described at least in U.S. Patent No. 10,820,995 to Czyscon et al., entitled "Inversion Delivery Device and Method for a Prosthesis." This delivery device was designed to flatten the learning curve for its use by providing a positioning mechanism that automatically initiates the inversion process once a predetermined length of the implant has exited the delivery catheter. The device used a combination of a carriage and a follower arm that interacts with a lead screw to change the direction of carriage movement while maintaining manual rotation of a knob to rotate the lead screw in a single direction.

[0018] While this device has greatly improved ease of use during delivery, it requires at least two-handed operation and in many cases requires two people to operate. There is a need for a device that can be safely and effectively operated by one person.

[0019] In addition to the need for improved delivery systems, mechanical heart valves present numerous design challenges that must be overcome to achieve effectiveness. Just a few of these challenges include being able to deliver easily, accurately, and atraumatically, being able to load the device into a delivery device without damaging it, being able to withstand hundreds of millions of cycles without suffering performance degradation, and being able to implant securely so as not to experience valve migration or paravalvular leakage. The list of design considerations is long, and a mechanical heart valve that functions similarly to a healthy native valve may never be created. For this reason, improved prosthetic valves are constantly needed.

[0020] One challenge presented by the design of prosthetic heart valves is to attach or secure the implant to the target attachment site. The leaflets of a natural valve are pliable and extend directly from the conduit through which fluid is regulated. Prosthetic valves, particularly those delivered from a catheter, typically include pliable leaflet material attached to a rigid support structure such as a stent or wireform or a combination thereof. Delivering such a device can stress the soft leaflet material as it is expelled from the delivery catheter. Thus, there is a need for an implant design that protects the delicate leaflets during the delivery process.

[0021] Paravalvular leakage is another concern that needs to be addressed. Paravalvular leakage refers to blood circulating around the prosthetic valve implant, rather than through the leaflets. This leakage results in regurgitant flow and reduced valve effectiveness. The optimal atraumatic implantation technique involves pushing the native leaflets out of the way, without resecting them. This often results in irregular implantation site geometry. The support structure needs to be pliable enough to conform to the implantation site geometry, thus forming a seal between the implant and the target site, while still providing enough support to form coapted leaflets and securely anchor the implant. The design must also prevent leakage between the leaflets and the inner surface of the support structure. Summary of the Invention

[0022] The present application is directed to a device that addresses the need for an automated delivery device that allows for one-handed operation. This need is addressed by providing a powered delivery device that completes all or most of the delivery process by pressing a button that activates a motor. Additionally, described herein is a heart valve developed to work with a delivery device that is constructed to protect the soft leaflet material during delivery by preventing contact between the leaflet material and the delivery catheter. The implant also includes a skirt and liner that prevent paravalvular leakage when the implant is in a collapsed configuration.

[0023] One aspect of the invention is a heart valve implant including a tubular braided support structure having an unfolded configuration and a folded configuration. The tubular support structure has a proximal end formed with a plurality of cusps. Each cusp has a high point and a low point on either side of the high point. The support structure further includes a distal end and first and second circumferential preformed folds between the distal and proximal ends of the tubular braided support structure. The circumferential preformed folds bias the tubular braided support structure toward the folded configuration.

[0024] In at least one embodiment of the invention, the heart valve implant also includes a leaflet assembly having a wireform having a plurality of commissure points separated by arcuate portions and valve material attached to the wireform, the wireform shaping the valve material into coapted leaflets when the valve material is attached to the wireform.

[0025] In at least one embodiment, the leaflet assembly is attached to the inner surface of the support structure such that the commissures of the wireform are aligned with the cusps of the support structure, ensuring that the soft valve material does not come into contact with the delivery catheter during loading or delivery, as the braided support structure acts as a barrier between the catheter and the valve assembly.

[0026] One aspect of the invention provides a heart valve implant including a tubular braided support structure having an unfolded configuration and a folded configuration, the support structure having a distal end, a proximal end, and first and second circumferential preformed folds between the distal and proximal ends of the tubular braided support structure, the circumferential preformed folds biasing the tubular braided support structure toward the folded configuration.

[0027] In at least one embodiment, the implant also includes a leaflet assembly having a wireform including a plurality of commissure points separated by arcuate portions and valve material attached to the wireform, the wireform shaping the valve material into coapted leaflets when the valve material is attached to the wireform, and the leaflet assembly is attached to an inner surface of the support structure such that the valve material is protected from contact with the delivery catheter by the support structure.

[0028] Another aspect of the invention is a support structure for a heart valve implant having a proximal end formed from a plurality of cusps, each having a high point and a low point on either side of the high point 326, a distal end, and first and second circumferential preformed folds between the distal and proximal ends of the support structure, where the circumferential preformed folds bias the support structure toward a folded configuration.

[0029] In at least one embodiment, when the support structure is in the collapsed configuration, the support structure forms a tri-layered intermediate region, a single-layered proximal region, and a single-layered distal region. The single-layered proximal region includes a proximal portion of a plurality of apexes, which includes a high point.

[0030] In at least one embodiment, the invention provides a delivery device for an implant comprising: a control cable having distal and proximal ends attachable to the implant; a delivery catheter encircling the control cable and having distal and proximal ends; and a handle assembly adjustably connected to the proximal end of the control cable and to the delivery catheter, the handle assembly including: a motor; a battery pack capable of powering the motor; at least one controller connected between the battery pack and the motor, the controller operable to provide power having a first polarity to power the motor in a first direction and operable to provide power having a second polarity to power the motor in a second direction; and a drive mechanism that moves the control cable in a distal direction and the delivery catheter in a proximal direction relative to the handle when the motor is powered in the first direction and moves the control cable in a proximal direction and the delivery catheter in a distal direction when the motor is powered in the second direction.

[0031] Another aspect of the invention is a delivery system for delivering an implant to a target site within a patient comprising: a powered delivery device having a handle, a delivery catheter assembly extending distally from the handle, and a motor contained within the handle and operable to pull a connector into the delivery catheter during a loading procedure and to store the delivery catheter relative to the implant during the delivery procedure; and a loading tray usable to assist in loading the implant into the delivery device, the loading tray including a handle section sized and shaped to hold the handle in a desired position, a loading container usable to contain a solution during the loading procedure, and a channel leading from the handle section to the loading container and sized to hold the delivery catheter during the loading procedure.

[0032] Yet another aspect of the invention is a method of delivering an implant to a target location including loading the implant into a distal end of a delivery catheter, navigating the distal end of the delivery catheter to the target location, actuating a motor in a first direction within a handle associated with the proximal end of the delivery catheter that retracts relative to the implant, thereby allowing the implant to expand within the target location, and releasing the implant. [Brief description of the drawings]

[0033] These and other aspects, features and advantages of embodiments of the present invention will become apparent and elucidated from the following description of embodiments of the invention, taken in conjunction with the accompanying drawings.

[0034] [Figure 1] FIG. 1 is a schematic diagram of the basic components of an embodiment of the present invention. [Diagram 2] FIG. 2 is a plan view of an embodiment of a delivery catheter assembly of the present invention. [Diagram 3] FIG. 3 is a plan view of an embodiment of a nose cone according to the present invention. [Figure 4] FIG. 4 is a top view of an embodiment of a lead screw in accordance with the present invention. [Diagram 5] FIG. 5 is a side view of an embodiment of a handle assembly with the cover removed to show the internal components in accordance with the present invention. [Figure 6] FIG. 6 is a perspective view of an embodiment of a handle assembly according to the present invention. [Figure 7] FIG. 7 is a perspective view of an embodiment of a valve connector according to the present invention. [Figure 8] FIG. 8 is a perspective view of an embodiment of an implant according to the present invention. [Figure 9] FIG. 9 is a front view of an embodiment of a support structure according to the present invention in an unfolded configuration. [Figure 10] FIG. 10 is a perspective view of an embodiment of a support structure according to the present invention. [Figure 11]FIG. 11 is a perspective view of an embodiment of an implant of the present invention in a relaxed state. [Figure 12] FIG. 12 is a cross-sectional profile view of an embodiment of a folded support structure of the present invention. [Figure 13] FIG. 13 is a perspective view of an embodiment of a valve assembly according to the present invention showing the wireform and valve material. [Figure 14] FIG. 14 is a front view of an embodiment of a wireform in accordance with the present invention. [Figure 15] FIG. 15 is a distal end view of an embodiment of an implant according to the present invention in an uncompressed, unfolded configuration. [Figure 16] FIG. 16 is a perspective view of a delivery device packaged in an embodiment of an accessory kit of the present invention. [Figure 17] FIG. 17 is a side view of an embodiment of a loading tool according to the present invention. [Figure 18] FIG. 18 is a cross-sectional view of the loading tool of FIG. 17 taken along section line AA. [Figure 19] FIG. 19 is a side view of an embodiment of a loading tool adaptor in accordance with the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] Hereinafter, specific embodiments of the present invention will be described with reference to the accompanying drawings. However, the present invention may be embodied in many different forms and should not be construed as being limited to the embodiments described herein, but rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the present invention to those skilled in the art. The terms used in the detailed description of the embodiments illustrated in the accompanying drawings are not intended to limit the present invention. In the drawings, like numerals refer to like elements.

[0036] 1, there is a schematic diagram of the basic components of the present invention. The present invention generally includes a delivery device 10, an implant 300, and an accessory kit 500.

[0037] delivery device The delivery device 10 generally includes a delivery catheter assembly 20, a nosecone 50, and a handle assembly 100. Figure 2 shows the delivery catheter assembly 20, which in at least one embodiment includes a formed delivery catheter 22. The delivery catheter 22 is reinforced with axial fibers along its length to provide improved strength, durability, and deliverability. In addition, the delivery catheter 22 has a hydrophilic coating that improves trackability.

[0038] The delivery catheter 22 has a straight section 24 extending from the handle assembly 100 (see FIG. 5) from its proximal end to the capsule 30 at its distal end. In at least one embodiment, the straight section 24 has an outer diameter of 0.150 inches to 0.250 inches. Optimal results have been achieved with an outer diameter of about 0.185 inches. The straight section 24 has an inner diameter of 0.100 inches to 0.200 inches. Optimal results have been achieved with an inner diameter of about 0.155 inches. As can be seen, the capsule 30 has slightly larger inner and outer diameters to carry the valve to the desired location. Thus, the straight section 24 transitions into the capsule 30 and has a taper 26 at its distal end and is approximately 1.0 inch in length.

[0039] The capsule 30 is a pre-shaped curved section of the catheter 22 that extends distally from the straight section 24 and carries the valve implant 300 (see FIG. 8). The curved capsule 30, in at least one embodiment, has an average radius of 1.5 inches to 2.5 inches. Optimal results have been achieved with an average radius of about 1.92 inches. In at least one embodiment, the curve has a decreasing radius from the proximal end to the distal end. For example, in one embodiment, the capsule 30 transitions from a radius of about 2.3 inches at about 45 degrees from the straight section 24, to a radius of about 1.85 inches at about 90 degrees from the straight section 24, to a radius of about 1.4 degrees at about 135 degrees from the straight section 24.

[0040] In at least one embodiment, the curved capsule 30 has an outer diameter of 0.200 inches to 0.300 inches, with optimal results achieved at an outer diameter of approximately 0.236 inches. In at least one embodiment, the curved capsule 30 has an inner diameter of 0.150 inches to 0.250 inches, with optimal results shown to be approximately 0.208 inches. The delivery catheter 22 slides within an outer sheath 32, which is connected to a handle assembly 100.

[0041] The nose cone 50 is best shown in FIG. 3. The nose cone 50 is located at the distal end of the curved capsule 30 and is shaped to be inserted into and easily removed from the distal end of the capsule 30. The shaped catheter 22 is designed to be passed over a guidewire 40 navigated to the target site. The nose cone 50 provides atraumatic delivery of the catheter to the target location while passing over the guidewire 40.

[0042] The nosecone 50 is preferably made of a soft material. In at least one embodiment, the nosecone 50 has a durometer of less than 40D. Optimal results have been achieved with a material having a durometer of 35D. The nosecone 50 has a distal leading taper 52, a proximal taper 54, and a cylindrical section 56 between the leading taper 52 and the proximal taper 54. The proximal taper 54 aids in recapture of the nosecone 50 after implantation has occurred. Additionally, the proximal taper 54 facilitates insertion of the nosecone into the distal end of the catheter 22 during assembly.

[0043] Cylindrical portion 56 is sized to allow the implant to be advanced out of the end of catheter 22 when delivered, while maintaining proper alignment of the distal end of catheter 22. For example, a cylindrical portion 56 having an outer diameter of 0.200 inches to 0.206 inches has demonstrated optimal results when used with a catheter having an inner diameter of 0.208 inches at its distal end.

[0044] The leading taper 52 is sized to be flush with the outer diameter of the catheter, thereby creating a smooth transition between the catheter and the nosecone 50. The difference in diameter between the cylindrical portion 56 and the proximal end of the leading taper 52 creates a shoulder 58 that is approximately flush with the distal end of the catheter 22. This provides the smooth transition mentioned above and provides a stop when inserting the nosecone 50 into the distal end of the catheter 22. In one embodiment, the leading taper 52 has a diameter of 0.232 to 0.238 inches and tapers to a distal end having a diameter of approximately 0.040 inches.

[0045] Similar to catheter 22, nosecone 50 includes a hydrophilic coating to improve lubricity for tracking. Additionally, nosecone 50 has a guidewire lumen 60 that extends through the length of nosecone 50 and the distal end of guidewire lumen 60, where the valve contacts proximal taper 54, also has a hydrophilic coating to reduce sliding friction between the valve and guidewire lumen 60. In at least one embodiment, nosecone 50 and guidewire 40 are decoupled from valve actuation to provide depth stability of the nosecone during implant deployment.

[0046] The handle assembly 100 is shown in Figures 4-6 and generally includes a drive assembly 110, a motor assembly 200 that powers the drive assembly 110, a housing 132, and a number of controls 140 for controlling the motor assembly 200 and releasing the implant 300 during implantation. The motor assembly 200 is powered by a battery pack 210.

[0047] The drive assembly 110 includes a lead screw 112 that creates relative motion between the implant 300 and the catheter 22 when rotated. With reference to FIG. 4, the lead screw 112 can be seen to include a proximal portion 114 and a distal portion 116. The proximal portion 114 includes a left-handed thread 118 of varying pitch. A valve nut 122 engages the threads and translates axially as the lead screw 112 rotates. The valve nut 122 acts against an adjacent valve carriage 124 that is connected to a valve retention cable 150. The valve retention cable 150 is connected to the implant 300 via three valve connectors 152 that extend from the distal end of the valve retention cable 150, which is a trifurcated prong.

[0048] The distal end of the lead screw 112 includes a right-hand thread 120 of varying pitch. A catheter nut 126 engages the right-hand thread 120 and translates axially as the lead screw 112 rotates. The catheter nut 126 acts against an adjacent catheter carriage 128 (see FIG. 5 ) connected to the delivery catheter 22 and translates axially within the outer sheath 32. The outer sheath 32 is secured to the distal end of a handle housing 132.

[0049] 5, the valve carriage 124 and the catheter carriage 128 are axially aligned with the catheter assembly 20. The distal end of the valve carriage 124 is connected to the proximal end of a valve retention cable 150. The valve retention cable 150 passes through the catheter carriage 128 and into the proximal end of the lumen of the delivery catheter 22.

[0050] The varying pitch of the left and right threads 118, 120 controls the speed and direction that the carriages 124 and 128 translate. These speeds are determined by the optimal speed of the delivery catheter 22 relative to the implant 300 during implantation and storage. These speeds are explained in more detail below in the operational discussion. The different lengths of the left and right threads 118, 120 accommodate the varying pitch such that the same number of turns of the lead screw 112 are required for both carriages 124 and 128 to reach their respective travel limits.

[0051] The controls 140 of the handle assembly 100 include at least an advance button 142 and a retract button 144. The advance button 142 is a switch that connects power from the battery pack 210 to the motor assembly 200, causing rotation of the lead screw 112 in a first direction. The retract button 144 is a switch located proximal to the advance button 142 and connects power from the battery pack 210 to the motor assembly 200 with a polarity opposite that of the advance button, thereby rotating the motor assembly 200 in a second direction and causing the lead screw 112 to rotate in a second direction. Those skilled in the art will recognize that numerous switch and button configurations may be used to achieve this result without departing from the spirit of the present invention.

[0052] The handle assembly 100 includes a guidewire port 134 near the proximal end of the housing 132. The guidewire port 134 allows the delivery device 10 to be passed over the guidewire 40. In doing so, the guidewire 40 passes through the cone assembly, through the guidewire lumen 60 formed in the delivery catheter 22, and out the guidewire port 134.

[0053] 6, the handle assembly 100 also includes three flush ports 146, 147, and 148 on the side of the handle housing 132. The flush ports 146, 147, 148 are used to flush air from the luminal spaces within the delivery system prior to use with a patient. The flush ports 146, 147, 148 include luer connectors 160, 162, and 164 for connecting flushing syringes to push air out of the luminal spaces of the delivery system after the implant is loaded.

[0054] FIG. 7 shows that the valve connectors 152 each have teeth 154 that extend from a mouth 156 to enable release of the implant 300 .

[0055] Implants 8, the implant 300 generally includes a support structure 320 that collapses upon release from the catheter 22, and a valve assembly 380 that includes leaflet material 382 and a wireform 360 to which the leaflet material 382 is attached. The leaflet material 382 and the wireform are configured such that, when the leaflet material 382 and the wireform are attached to one another, a valve assembly 380 is formed that includes leaflets that resemble the function of a healthy human heart valve.

[0056] The support structure 320 folds longitudinally and, when released from the delivery catheter 22, expands radially to push the native valve tissue outward, locking itself into place, holding and orienting the wireform and leaflet assembly in an optimal position, and preventing blood from leaking retrograde around the prosthetic valve (referred to herein as "paravalvular leakage").

[0057] Referring to Figure 9, a front view of an embodiment of the support structure 320 of the present invention in an unfolded configuration is shown. For purposes of clearly showing the braid pattern, the support structure 320 in Figure 9 has not yet been heat set and is therefore cylindrical. Also note that the support structure 320 in Figure 9 is shown as if it were disposed on a solid dowel or mandrel, such that the rear half of the structure is hidden from view. This provides a clearer view of the braid pattern of the support structure 320.

[0058] The support structure 320 is a braided structure having a first end 322 and a second end 324. The first end 322 includes three high points 326, only one of which is visible in FIG. 9 because the rear portion of the support structure 320 is not shown. FIG. 10 shows all three high points 326. Each of the high points 326 is formed by two long braids 330A and 330B that run in opposite directions and terminate where they cross each other to form the high point 326. All the remaining braids are of various lengths such that they end (change direction) at points approximately aligned with the braids 330A and 330B that form the high point 326. The result is a three-pronged first end 322 with three apexes 332A, 332B, and 332C (see FIGS. 9 and 10), the function of which will be explained below.

[0059] The support structure 320 is divided into three longitudinal sections 340, 342, and 344. The longitudinal sections are separated by two preformed folds 346 and 348, shown as dotted lines in Figure 9 and visible in the unfolded, relaxed state in Figure 11. The preformed folds 346 and 348, at a minimum, assist the support structure 320 in reconfiguring from an unfolded configuration during deployment to a folded configuration when released from the delivery device 10.

[0060] The first longitudinal section 340 includes the first end 322 of the support structure 320 and extends below where the apexes 332A, 332B, and 332C intersect with adjacent apexes. The second longitudinal section 342 is located between the first fold 346 and the second fold 348. The third longitudinal section 344 extends from the second fold 348 to the second end 324 of the support structure 320.

[0061] The second end 324 of the support structure 320 terminates in a plurality of braids having a different braid pattern than that of the second longitudinal section 342. The pitch of the braids results in ventricular flared loops 328 that help secure the support structure 320 to the native valve. These loops flare outward to help secure the implant 300, as shown in FIG.

[0062] FIG. 10 illustrates the support structure 320 in a folded configuration. For purposes of clarity of explanation, and because the second end 324 exits the delivery device first during a typical non-transapical delivery, the second end 324 will be designated as the distal end and the first end 322 as the proximal end. In the unfolded state, the first preformed fold 346 is located proximal to the second preformed fold 348. In the folded configuration, the second longitudinal section 342 inverts such that the outer surface of the second longitudinal section faces inward. The outer surfaces of the first and third longitudinal sections do not invert and remain facing outward. As the second longitudinal section 342 inverts, the first section 340 is pulled into the second section, and the first and second sections are pulled into the third section 344. Thus, as shown in FIG. 12, the three longitudinal sections nest within one another and are no longer longitudinally adjacent. Rather, section 340 becomes an inner layer, section 342 becomes a middle layer, and section 344 becomes an outer layer. Figure 12 is a simplified cross-sectional view showing the three sections 340, 342 and 344 in a folded configuration.

[0063] 10 and 12, the three segments of support structure 320, when folded, result in a device having a tri-layered intermediate region 350, a single-layered proximal region 352, and a single-layered distal region 354. Proximal region 352 is formed by the tips of cusps 332A, 332B, and 332C. Distal region 354 is formed by the end of ventricular flared loop 328.

[0064] As discussed above, the implant 300 includes a wireform 360 and a valve assembly 380 (FIG. 13) including tissue 382, ​​such as porcine tissue. FIG. 14 illustrates an embodiment of the wireform 360 of the present invention. The wireform 360 includes three commissure points 362A, 362B, and 362C. The commissure points have loops 364A, 364B, and 364C at their tips that are used as attachment points for connecting the prosthetic valve implant 300 to the valve connector 152 of the delivery device 10. Each of the loops 364A, 364B, and 364C is angled differently to work optimally with the connections of the delivery device 10. Each of the loops 364A, 364B, and 364C is angled such that a vertical plane that roughly contains the loop intersects a similar plane of two other loops near the axial center of the wireform 360. Intersections 362A, 362B, and 362C are separated by arcuate portions 366A, 366B, and 366C. At the midpoint of each arcuate portion 366A, 366B, and 366C is a loop 368A, 368B, and 368C, respectively. In the embodiment of Figure 14, wireform 360 is made from a single wire, the two ends of which are connected end-to-end with connector 370.

[0065] 13, the wireform 360 is used to create a valve assembly 380 using valve material 382, ​​which may be harvested tissue, such as porcine or bovine tissue, or may be synthetic tissue. In at least one embodiment, the valve material 382 includes three separate sheets of material 384A, 384B, and 384C that are sewn, welded, or otherwise joined together and, together with the wireform 360, form three leaflets 386A, 386B, and 386C. In FIG. 13, sheet 384A and leaflet 386A are clearly shown, sheet 384C and leaflet 386C are on the left, and sheet 384B and leaflet 386B are hidden from view.

[0066] In at least one embodiment, each of the sheets 384A, 384B, and 384C is longitudinally longer than the wireform 360. Each of the sheets 384A, 384B, and 384C is attached to the wireform 360 using sutures or other attachment techniques or materials such that the proximal edges 388A, 388B, and 388C are located just distal to the loops 364A, 364B, and 364C. The proximal edges 388A, 388B, and 388C form the coaptation edges of the valve assembly 380. The location of the loops 364A, 364B, and 364C proximal to the edges 388A, 388B, and 388C ensures that the loops, and corresponding connectors 152 of the delivery device 10, do not interfere with the opening and closing of the leaflets 386A, 386B, and 386C during delivery. This allows the implant 300 to be fully functional while it is still connected to the delivery device 10. Thus, verification of correct placement and function can be performed prior to release. If the implant 300 is not correctly placed, it can be pulled back into the delivery device 10 and repositioned.

[0067] The material of the sheets 384A, 384B and 384C extending distally of the wireform 360 are sewn or otherwise joined together to form a skirt 390 having a distal edge 392. In at least one embodiment, the distal edge 392 is located distal to the more proximal preformed fold 346. Thus, as the support structure 320 is folded, as shown in Figures 12 and 15, the skirt 390 folds and forms an internal seal within the support structure 320 that prevents paravalvular leakage.

[0068] FIG. 15 is a distal end view of the uncompressed, unfolded configuration of implant 300. An inside view of distal edge 392 of skirt 390 is shown, and proximal preformed fold 346 is also visible. Referring again to FIG. 11, which is an outside perspective view of the uncompressed, unfolded configuration of implant 300, one can see the arrangement of skirt 390, wireform 360, and proximal and distal preformed folds 346 and 348, respectively. FIG. 11 also shows how valve assembly 380 is completely protected from contact with the inner surface of delivery device 10 by support structure 320.

[0069] In addition, there is an optional distal liner 394 that extends around the inner surface of the distal end of the support structure 320. Referring again to FIG. 12, the distal liner 394 works in conjunction with the skirt 390 to form an "articulated skirt." In the folded configuration, the tissue layer may be described as having an inner layer 400 that is comprised of the leaflets 386A, 386B, and 386C and the portion of the skirt 390 that extends distally to the first preformed fold 346. The tissue skirt 390 follows around the fold 346 and continues proximally to create an intermediate layer 402. The liner 394 may be described as an outermost layer 404 that is located on the inner surface of the distal end of the support structure 320 and faces the intermediate layer 402. When the support structure 320 is folded and compressed by the implantation site, the intermediate layer 402 and the outermost layer 404 are compressed together to form a seal that prevents paravalvular leakage. The gap between the proximal edge of the liner 394 and the distal edge 392 of the skirt 390 ensures that bunching or other adverse effects do not occur when the support structure 320 is folded.

[0070] Accessory Kit 16, the accessory kit 500 may include a loading tray 510, a loading tool 540, and a loading tool adapter 560. The loading tray 510 in combination with a lid (not shown) also serves as the packaging for the system. The loading tray 510 is rigid and developed to allow a single operator to load the implant 300 into the delivery device 10. The tray 510 includes a handle section 512, a loading container 514, and a channel 516 that leads from the handle section 512 to the loading container 514. The channel 516 is curved and accommodates the delivery catheter 22. The channel 516 has a retaining clip 518 that covers the channel 516 so that the delivery catheter 22 remains in the channel 516 after the lid is removed. The loading container 514 provides a place where the implant 300 may be rinsed prior to loading.

[0071] 17 and 18 show an embodiment of a loading tool 540, which is a funnel-like device that allows the implant 300 to be loaded into the distal end of the delivery catheter 22. The loading tool 540 has a wide side 542 and a narrow side 544. The loading tool 540 works in conjunction with a loading tool adaptor 560, shown in FIG. 19, which has a flange 562 with a diameter sized to raise the tip of the catheter 22 to a desired height and support the tip while loading the implant. In at least one embodiment, the loading tool 540 is made from clear polycarbonate and the loading tool adaptor 560 is made from Delrin. The flange 562 has a central lumen 564 sized to receive the distal tip of the delivery catheter 22. The other end 568 has an outer diameter sized to fit within the narrow side 544 of the loading tool 540.

[0072] operation The operation begins with the loading of the implant 300. The lid is removed from the tray 510 and the rinse container 514 is filled with a solution, such as saline. The implant 300 is then placed in the solution and the distal end of the delivery catheter 22 is placed into the flange end of the valve loading tool adapter 560. The other end of the adapter 560 is inserted into the narrow side 544 of the valve loading tool 540.

[0073] The operator then presses advance button 142 to rotate lead screw 112 in a direction that translates the catheter 22 carriage and valve carriage 124 away from each other to the outer extent of lead screw 112. Separation of the carriages retracts catheter 22 proximally while advancing the valve control cable distally, exposing the three-pronged end of the valve control cable for loading of implant 300.

[0074] The operator then opens the valve connectors using the valve connector controls, the commissure loops are each placed into one of the open connectors, and the valve connector controls are used to close the connectors.

[0075] The implant 300 is now ready for loading into the delivery device 10. When the operator presses the retract button 144, the motor assembly 200 drives the lead screw 112 to translate the valve carriage 124 and the catheter carriage 128 away from each other, retracting the implant 300 proximally through the valve loading tool 540 and the valve loading tool adapter 560 and into the distal end of the catheter 22.

[0076] The operator continues to press the retract button 144 until the implant 300 is completely inside the capsule 30 and ready for delivery. The valve loading tool 540 and adapter 560 are then removed from the distal end of the catheter 22 and the delivery device 10 is ready to be removed from the tray 510 after opening the retaining clips 518 when the physician is ready to deliver the implant 300.

[0077] Once prepared, the physician navigates the guidewire 40 through the damaged native valve. The proximal end of the guidewire 40 is then inserted into the distal end of the nosecone 50, which, with the aid of the proximal taper 54 of the nosecone 50, is inserted into the distal end of the catheter 22. The delivery device 10 is advanced over the guidewire 40 until the distal end of the catheter 22 is at the target site, which is verified by fluoroscopy, using the radiopaque band at the distal end of the outer sheath 32. As the delivery device 10 is advanced over the guidewire 40, the proximal end of the guidewire 40 passes through the guidewire port of the handle.

[0078] Once satisfied with the position of the distal end of the delivery device 10, the physician presses the advance button 142, which rotates the lead screw 112 and translates the valve and catheter carriages 124 and 128 toward each other until the implant 300 begins to emerge from the distal end of the delivery catheter 22. The third longitudinal section of the implant 300 expands against the damaged valve and begins to expand the native valve.

[0079] As the physician continues to hold the advancement button 142, the interaction between the third longitudinal section and the native valve helps hold the implant 300 in place while the second section of the implant 300 advances and everts into the third longitudinal section. Everting is aided by the second preformed fold reassuming the biased folded configuration.

[0080] It is important to note that at any point during the procedure prior to releasing the implant 300, the physician can release the advance button 142 and, if dissatisfied with the placement of the implant 300, press the retract button 144 to retract the implant 300 back into the delivery catheter 22. This also allows the physician to quickly stop the procedure entirely and remove the delivery device 10 from the patient.

[0081] As the advance button 142 continues to be pressed, the delivery catheter 22 continues to move proximally, exposing the first section and valve connector of the implant 300. The physician can then view the position and operation of the implant 300 via fluoroscope before releasing the advance button 142 and releasing the implant 300. The design of the implant 300 and delivery apparatus 10 provides the physician with the ability to view the implant 300 fully functioning before releasing the implant 300.

[0082] If the physician is unhappy with the operation of the implant 300, the physician presses the retract button 144 and the implant 300 is pulled back into the delivery catheter 22 as described during the loading sequence, except that the loading tool 540 and adapter 560 are not used. When the physician is satisfied with the operation of the implant 300, the implant 300 is released from the connector by first pulling the locking pin 541 and then manipulating the valve connector control. The locking pin 541 prevents premature release of the implant by preventing the implant device from advancing the lead screw to the release point where the implant is released.

[0083] Although the present invention has been described with respect to specific embodiments and applications, those skilled in the art can, in view of this teaching, generate additional embodiments and modifications without departing from the spirit or beyond the scope of the invention as claimed. It should therefore be understood that the drawings and descriptions herein are provided by way of example to facilitate understanding of the invention and should not be construed as limiting its scope.

Claims

1. A system comprising: Cardiac implants and a delivery device coupled to the cardiac implant; wherein the delivery device comprises: a control element having a distal end and a proximal end, the distal end being attachable to the cardiac implant; a delivery catheter surrounding the control element and having a distal end and a proximal end; a handle assembly adjustably connected to the proximal end of the control element and to the delivery catheter, A motor and a power source capable of powering the motor; at least one controller connected between the power source and the motor, operable to provide power having a first polarity to power the motor in a first direction and operable to provide power having a second polarity to power the motor in a second direction; a handle assembly including a drive mechanism that moves the control element distally and the delivery catheter proximally relative to the handle assembly when the motor is energized in the first direction, and moves the control element proximally and the delivery catheter distally when the motor is energized in the second direction.

2. The cardiac implant is a heart valve implant, and the heart valve implant comprises:

1. A tubular braided support structure having an unfolded configuration and a folded configuration, comprising: a proximal end formed with a plurality of cusps, each having a high point and a low point on either side of the high point; a distal end; and a tubular braided support structure including first and second circumferential preformed folds between the distal and proximal ends of the tubular braided support structure, the first and second circumferential preformed folds biasing the tubular braided support structure toward the collapsed configuration; 1. A valve leaflet assembly comprising: a wireform including multiple commissure points; and a valve material attached to the wireform. a leaflet assembly, wherein when the valve material is attached to the wireform, the wireform shapes the valve material into coapted leaflets; The system of claim 1 , wherein the leaflet assembly is attached to an inner surface of the support structure such that the commissure points of the wireform are aligned with the cusps of the support structure.

3. The system described in claim 2, wherein the low point between adjacent cusps is shared by the adjacent cusps, and when the support structure is in the folded configuration, the cusps extend proximal to the second preformed fold.

4. The system described in claim 2, wherein a complete loop defines the distal end of the braid of the braided support structure, and the complete loop is connected to the braid that forms the high point of one of the multiple peaks.

5. The wire form: a plurality of commissure points, the commissure points including tips with loops that provide attachment points for the delivery device; the wireform is nested within the support structure such that the valve material is located inside the support structure; the wireform being formed from a single wire having ends joined together with a connector; The system of claim 2 , comprising one or more of:

6. The system described in claim 2, wherein each of the multiple commissure points is separated by an arcuate portion that includes a loop at the midpoint of the arcuate portion.

7. The valve material is a plurality of sheets sewn together such that the proximal end of each sheet forms a valve leaflet; and the valve material extends distal to the first preformed fold such that the valve material is folded at the first preformed fold; The system of claim 2 , comprising one or more of:

8. The system described in claim 2, further comprising a distal liner lining the inner surface of the support structure distal to the second preformed fold.

9. The system described in claim 2, wherein operating the motor in a first direction retracts the delivery catheter toward the cardiac implant, thereby allowing the cardiac implant to expand within a target location.

10. A system comprising: Cardiac implants and a delivery system coupled to the cardiac implant for delivering the cardiac implant to a target site within a patient; wherein the delivery system comprises: a powered delivery device having a handle, a delivery catheter assembly extending distally from the handle, and a motor contained within the handle and operable to pull a connector into the delivery catheter during a loading procedure and to retract the delivery catheter relative to the cardiac implant during a delivery procedure; a loading tray usable to assist in loading the cardiac implant into the delivery device, a handle section sized and shaped to hold the handle in a desired position; a container operable to contain a solution during said loading procedure; a loading tray including a channel leading from the handle section to the container, the channel being sized to hold the delivery catheter during the loading procedure; A system comprising:

11. The cardiac implant comprising a cardiac valve implant, the cardiac valve implant comprising:

1. A tubular braided support structure having an unfolded configuration and a folded configuration, comprising: a tubular braided support structure including first and second circumferential preformed folds between a distal end and a proximal end of the tubular braided support structure, the first and second circumferential preformed folds biasing the tubular braided support structure toward the collapsed configuration; a leaflet assembly including valve material attached to a wireform that shapes the valve material into coapted leaflets; Equipped with The system of claim 10 , wherein the leaflet assembly is attached to an inner surface of the support structure, and the valve material is protected from contact with the delivery catheter by the support structure.

12. The system described in claim 11, wherein the proximal end of the tubular braided support structure includes a plurality of peaks, each having a high point and a low point on either side of the high point.

13. The system described in claim 12, wherein the plurality of cusps includes three cusps.

14. The system described in claim 13, wherein the leaflet assembly is attached to the inner surface of the support structure so that the commissure points of the wireform are aligned with the cusps of the support structure.

15. The system described in claim 11, wherein the complete loop defines the distal end of the braid of the braided support structure.

16. The system described in claim 11, wherein the wireform has a commissure point including a tip with a loop that provides an attachment point for a delivery device.

17. A support structure for a heart valve implant, comprising: a proximal end formed with a plurality of cusps, each having a high point and a low point on either side of the high point; a distal end; and first and second circumferential preformed folds between the distal and proximal ends of the support structure, the first and second circumferential preformed folds biasing the support structure toward a folded configuration; when the support structure is in the folded configuration, the support structure forms a three-layer intermediate region, a single-layer proximal region, and a single-layer distal region; A support structure for a heart valve implant, wherein the single-layered proximal region includes a proximal portion of a plurality of cusps including the high point.

18. The support structure described in claim 17, wherein the single-layer distal region comprises a ventricular flare loop.

19. A support structure as described in claim 17, wherein the three-layer intermediate region extends from the first circumferential preformed fold to the second circumferential preformed fold, and the three-layer intermediate region includes the low point.

20. The support structure described in claim 17, wherein the single-layer distal region is one of an outer layer and an inner layer.

Images