Valve delivery systems and methods

Abstract

The present invention relates to a delivery system for a prosthetic heart valve comprising: an elongate body having a proximal end, a distal end, and at least two bending portions, the two bending portions having different bending directions; an inner tube having a proximal end and a distal end and disposed inside an outer tube; an operating distal end located at the distal end of the outer tube, the operating distal end comprising an implant holder having at least two implant leg holders, one of which is configured to hold one of the legs in an axially proximal position relative to the other; an atraumatic distal tip connected to the distal end of the implant holder; and an implant enclosure externally surrounding the implant, the implant enclosure connected proximate to the distal end of the outer tube and extending to the proximal end of the distal tip.

Description

[Technical field]

[0001] Related Applications This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 273,970, filed October 31, 2021, the contents of which are incorporated herein by reference in their entirety. [Background technology]

[0002] The present invention, in some embodiments thereof, relates to valve delivery systems and associated methods, and more particularly, but not exclusively, to prosthetic valve replacement delivery systems and associated methods for the tricuspid valve.

[0003] Tricuspid regurgitation (TR) occurs when the tricuspid valve does not close properly, allowing blood to leak backward from the right ventricle into the right atrium. Most cases of tricuspid regurgitation are accompanied by right ventricular dysfunction.

[0004] Treating patients with TR often requires valve replacement to reduce or eliminate regurgitation. In recent years, transvascular techniques have been developed to use flexible catheters to introduce and implant prosthetic heart valves in a less invasive manner than open-heart surgery.

[0005] In the transvascular approach, the prosthesis is delivered to the target site (i.e. the tricuspid valve) via catheter while the device is crimped onto a small diameter shaft, and once the device is in the correct position, it is expanded / deployed to its functional size. The heart is functioning while the device is being positioned, meaning the heart is moving, blood is flowing, everything is moving while the physician is trying to place the device in the optimal position. In addition to this, the anatomy of the heart does not allow for direct and easy access of the device and implant to the required location. Current devices do not allow for easy and precise adjustment of the device positioning during implantation.

[0006] Additional background art includes U.S. Pat. No. US10137019B2, which discloses a medical device including "a first rod, a second rod extending along the first rod, a longitudinal centerline defined by the rods, and a manipulator. The manipulator includes a plurality of fingers, each finger having a first finger end and a second finger end. The second finger end is a free end. The first finger end is supported on the second rod such that the fingers are operable to move from a first position to a second position by moving the second rod relative to the first rod. A distance from the free end of the finger to the longitudinal centerline in the first position is different compared to the second position. Stents, ring prostheses, and prosthetic devices are also described."

[0007] International Patent Application Publication No. WO2019086958A1 discloses "a device assembly for implanting an endovascular prosthesis in a human patient, the device assembly having a collapsed delivery configuration and an expanded deployed configuration, the device assembly comprising: a stent frame comprising a plurality of expandable stent cells arranged in a plurality of layers and stacked longitudinally; a valve attached to the stent frame; and an expandable sealing skirt coupled to the stent frame, the expandable sealing skirt comprising protruding regions and non-protruding regions configured to expand radially beyond the stent frame when the device assembly is in the expanded deployed configuration."

[0008] U.S. Patent No. US9763778B2 discloses "An anchoring device for use in a cardiovascular structure includes an expandable ring having a longitudinally extending central axis. At least one leg extends longitudinally from the ring. The leg includes a first end connected to the ring and a free end, and at least one anchor is connected to the leg. The anchoring device may be used to secure a transcatheter heart valve within the cardiovascular structure."

[0009] U.S. Patent No. US7402151B2 discloses "a method of easily and atraumatically accessing vascular regions that are normally difficult to access using a steerable guide catheter constructed of components selected to provide optimal navigability, torque transmission, and pushability for a variety of typical percutaneous access routes. The deflecting segment of the guide catheter has a catheter wall thickness of about 1 French (1 / 3 mm) or less and includes a slotted deflecting tube. This construction allows for a very small turning radius, enabling the guide catheter to access vascular regions that are normally inaccessible."

[0010] International Patent Application Publication No. WO2019038337A1 discloses a dual movable sheath, a delivery system including such a sheath, and a method for placing a medical device, such as a replacement heart valve prosthesis, within a patient's heart.

[0011] U.S. Patent No. US8096985B2 discloses "devices and methods for a guide catheter with one or more regions of enhanced flexibility. The flexibility region comprises a tubular segment of the guide catheter with a non-linear longitudinal seam between two non-concentric layers of material having different durometers. The non-linear seam, such as a zigzag or sinusoidal configuration, allows for controlled compression of the lower durometer material between sections of higher durometer material."

[0012] International Patent Application Publication No. WO2018174712A1 discloses a guidewire catheter assembly comprising: a catheter tube having a longitudinal channel; and a guidewire configured to be movable within the longitudinal channel, wherein the catheter tube comprises a bendable portion near a distal end thereof, the bendable portion having a variable flexibility in a circumferential direction of the catheter tube such that application of a longitudinal compressive force in a proximal direction at a compressed position distal to the distal end portion causes the bendable portion to bend; and the guidewire comprises an expandable portion, the expandable portion being movable between a non-extended position in which a cross-section of the expandable portion is smaller than a minimum cross-section of the longitudinal channel of the catheter tube and an extended position in which a cross-section of the expandable portion is larger than the minimum cross-section of the longitudinal channel of the catheter tube, wherein when the expandable portion is in the non-extended position, the guidewire can be moved completely in and out of the longitudinal channel of the catheter tube, and wherein when the expandable portion is in the non-extended position, the expandable portion is configured to exert a longitudinal compressive force in the compressed position to bend the bendable portion of the catheter tube.

[0013] US Patent No. US6869414B2 discloses "A catheter employing a preformed distal end and a proximal deflection mechanism for steering the catheter. A shaped member extends from a shaped region of the catheter sheath to at least a portion of the anchor region. A steering ribbon extends from the proximal region of the sheath and passes within at least a portion of the anchor region. A distal end of the steering ribbon is coupled to a proximal portion of the shaped member. At least one steering tendon is disposed within the sheath, with a first end attached to the anchor region and a second end disposed in the proximal region of the sheath. As the steering tendon moves proximally, the shape of the shaped region of the sheath is substantially maintained while the deflection region deflects relative to the longitudinal axis of the catheter."

[0014] European Patent No. EP0980693A1 discloses a "bidirectional electrode catheter having an elongated tubular catheter body, a catheter tip at the distal end of the catheter body, and a control handle at the proximal end of the catheter. The tip section has two generally opposed pairs of off-axis lumens. Two pairs of puller wires extend from the handle, through the catheter body, and to the pair of off-axis lumens in the tip section where they are secured to the tip section at various locations along the length of the tip section. Compression coils extend through the catheter body surrounding the puller wires. The proximal ends of the puller wires are attached to movable pistons in the control handle. Each piston is controlled by the operator using a slidable button secured to each piston. Movement of the selected button causes the tip section to bend into a generally planar "U" or "S" shaped curve." Summary of the Invention

[0015] Below is a non-exhaustive list including some example embodiments of the present invention. The present invention also includes embodiments including less than all of the features of an example, and embodiments that use features from more than one example, even if not explicitly listed below.

[0016] Example 1. A delivery system for a prosthetic heart valve comprising: a. an elongate body having a proximal end, a distal end, and at least two bends, the two bends having different bending directions; b. an inner tube disposed within the outer tube, the inner tube having a proximal end and a distal end; c. a manipulation distal end located at the distal end of the outer tube, the manipulation distal end comprising: i. an implant holder reversibly attached to the distal end of the inner tube, the implant holder comprising at least two implant leg holders, one of which is configured to hold one of the legs in an axially proximal position relative to the other; ii. an atraumatic distal tip connected to the distal end of the implant holder; iii. an implant enclosure externally surrounding the implant, the implant enclosure being connected proximate to the distal end of the outer tube and extending to a proximal end of the distal tip; the manipulation distal end comprising: The delivery system comprising:

[0017] Example 2. The delivery system of example 1, wherein the elongate body includes an outer flexible tube.

[0018] Example 3. The delivery system of example 1 or example 2, wherein the bending portion is configured to bend to a bending angle of about 0 degrees to about 180 degrees.

[0019] Example 4. A delivery system according to any one of Examples 1-3, wherein the outer flexible tube is made from one or more of braided Pebax, PEEK, and stainless steel.

[0020] Example 5. A delivery system as described in any one of Examples 1-4, wherein the elongate body is of sufficient length to reach the patient's heart from outside the patient's body using a femoral or jugular venous entry or other entry point.

[0021] Example 6. A delivery system as described in any one of Examples 1 to 5, wherein the elongate body comprises a port that is placed at an incision in the patient's body.

[0022] Example 7. A delivery system according to any one of Examples 1 to 6, wherein the elongate body is configured to move along the port.

[0023] Example 8. A delivery system according to any one of Examples 1 to 7, wherein the port comprises an inlet / outlet tube for inserting fluid into and removing fluid from a blood vessel.

[0024] Example 9. A delivery system according to any one of Examples 1 to 8, wherein the inner tube is made from one or more of braided Pebax, PEEK, and stainless steel.

[0025] Example 10. A delivery system described in any one of Examples 1 to 9, wherein the inner tube is one long tube.

[0026] Example 11. A delivery system described in any one of Examples 1 to 10, wherein the single long tube includes multiple zones having different levels of stiffness.

[0027] Example 12. A delivery system according to any one of Examples 1 to 11, wherein the inner tube comprises two or more sections.

[0028] Example 13. A delivery system described in any one of Examples 1 to 12, wherein the inner tube comprises two portions, a first portion extending from the handle of the delivery system to a specific position on the elongate body, and a second portion extending from the specific position on the elongate body to the operating distal end.

[0029] Example 14. A delivery system according to any one of Examples 1 to 13, wherein the second portion is covered with an envelope.

[0030] Example 15. A delivery system according to any one of Examples 1 to 14, wherein the first portion is harder than the second portion.

[0031] Example 16. The delivery system of any one of Examples 1 to 15, wherein the first portion is about 0.1% to about 50% harder than the second portion.

[0032] Example 17. A delivery system according to any one of Examples 1 to 16, wherein the second portion is softer than the first portion.

[0033] Example 18. The delivery system of any one of Examples 1 to 17, wherein the second portion is about 0.1% to about 50% softer than the first portion.

[0034] Example 19. A delivery system described in any one of Examples 1 to 18, wherein the implant holder is made from one or more of PEEK and stainless steel.

[0035] Example 20. A delivery system according to any one of Examples 1 to 19, wherein the implant enclosure is transparent.

[0036] Example 21. A delivery system described in any one of Examples 1 to 20, wherein the implant enclosure is sized and shaped to accommodate the prosthetic heart valve in a crimped configuration.

[0037] Example 22. A delivery system described in any one of Examples 1 to 21, further comprising a handle at the proximal end of the elongate body for actuating the delivery system.

[0038] Example 23. A delivery system according to any one of Examples 1 to 22, wherein the actuating includes actuating the at least two bending portions.

[0039] Example 24. A delivery system described in any one of Examples 1 to 23, wherein the actuating includes axially moving the elongate body.

[0040] Example 25. A delivery system described in any one of Examples 1 to 24, wherein the actuating comprises axially moving the inner tube.

[0041] Example 26. A delivery system described in any one of Examples 1 to 25, wherein the actuating is performed manually by actuating one or more knobs.

[0042] Example 27. A delivery system described in any one of Examples 1 to 26, wherein the actuating is performed electronically by running one or more motors.

[0043] Example 28. A delivery system described in any one of Examples 1 to 27, wherein the handle comprises one or more knobs for performing the actuation.

[0044] Example 29. A delivery system described in any one of Examples 1 to 28, wherein the handle has a quick release knob in communication with the elongate body and is configured such that by rotating the quick release knob, the elongate body can be rotated along its longitudinal axis.

[0045] Example 30. A delivery system described in any one of Examples 1 to 29, wherein the handle comprises an inlet / outlet tube configured to allow insertion / extraction of a substance from the delivery system.

[0046] Example 31. A method of delivering a prosthetic heart valve to a valve region located between an atrial space and a ventricular space using a delivery system, comprising: the delivery system comprises an elongate body having a distal end including a manipulation distal end containing the prosthetic heart valve in a crimped configuration; A virtual chord is defined between two locations adjacent the operative distal end, the virtual chord having a length; The method comprises: a. inserting the distal end into a subject's heart; b. positioning the operative distal end through the atrial space and the valve region into the ventricular space; c. retracting the operative distal end into the valve region by deforming at least a portion of the shaft adjacent the operative distal end, the deforming shortening the length of the virtual chord and the deforming aligning the operative distal end to be ±20 degrees perpendicular to the opening of the heart valve; The method comprising:

[0047] Example 32 The method of Example 31, wherein the at least a portion of the shaft is disposed within the atrial space during the deforming.

[0048] Example 33 The method of example 31 or example 32, wherein positioning the operative distal end in the ventricular space includes fully positioning the operative distal end in the ventricular space.

[0049] Example 34. The method of any one of Examples 31 to 33, wherein the method further comprises actuating the manipulation distal end to release the prosthetic heart valve within the valve region.

[0050] Example 35. The method of any one of Examples 31 to 34, wherein the actuating includes retracting the elongate body in a proximal direction.

[0051] Example 36. The method of any one of Examples 31 to 35, wherein the actuating includes pushing a prosthetic heart valve holder disposed within the operating distal end in a distal direction.

[0052] Example 37. The method of any one of Examples 31 to 36, wherein the releasing includes releasing a plurality of anchors of the prosthetic heart valve into the valve space at the ventricular space while retaining a remainder of the prosthetic heart valve within the operative distal end.

[0053] Example 38. A method as described in any one of Examples 31 to 37, wherein the releasing further comprises releasing one or more prosthetic heart valve leg holders of the prosthetic heart valve while retaining at least one of the prosthetic heart valve leg holders at the operating distal end after the release of the plurality of anchors.

[0054] Example 39. The method of any one of Examples 31 to 38, wherein the releasing further comprises manipulating the elongate body to further position the prosthetic heart valve within the valve region.

[0055] Example 40. The method of any one of Examples 31 to 39, wherein the releasing further comprises releasing at least one of the prosthetic heart valve leg holders of the prosthetic heart valve, thereby completely releasing the prosthetic heart valve from the operating distal end and within the valve region.

[0056] Example 41. The method of any one of Examples 31 to 40, wherein the deforming includes bending one or more locations of the elongate body.

[0057] Example 42. The method of any one of Examples 31 to 41, wherein the deforming includes bending the elongate body at two different locations.

[0058] Example 43. A method according to any one of Examples 31 to 42, wherein bending two different locations within the elongate body includes bending two different locations having opposite bending directions.

[0059] Example 44. A method of delivering a prosthetic heart valve using a delivery system, the delivery system comprising a manipulation distal end including the heart valve in a crimped configuration, the method comprising: a. inserting the delivery system into the subject's heart; b. bending at least a first portion of the delivery system to position a portion of the operative distal end of the delivery system within a ventricle of the heart; c. bending at least a second portion of the delivery system to position the portion of the operative distal end of the delivery system within the valve between the ventricle and the atrium; d. Releasing the prosthetic heart valve within the valve; and The method comprising:

[0060] Example 45. The releasing of the prosthetic heart valve within the valve comprises: a. partially releasing the prosthetic heart valve; b. modifying the placement of the prosthetic heart valve; c. Complete release of the heart valve; The method of Example 44, comprising one or more of the following:

[0061] Example 46. The method of example 44 or example 45, wherein the positioning of the portion of the operative distal end of the delivery system within the valve includes positioning the prosthetic heart valve substantially perpendicular to a valve opening.

[0062] Example 47. The method of any one of Examples 44 to 46, wherein the first portion of the delivery system and the second portion of the delivery system are adjacent to the operating distal end.

[0063] Example 48. The method of any one of Examples 44 to 47, wherein the bending of the first portion of the delivery system and the bending of the second portion of the delivery system include bending the portion of the delivery system within the atrium of the heart.

[0064] Example 49. The method of any one of Examples 44 to 48, wherein the bending of the first portion of the delivery system and the bending of the second portion of the delivery system comprise bending the portions of the delivery system in opposite bending directions to each other.

[0065] Example 50. The method of any one of Examples 44 to 49, wherein the method further comprises withdrawing the delivery system after the release of the prosthetic heart valve.

[0066] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein may be used in the practice or testing of embodiments of the present invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. Furthermore, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0067] Some embodiments of the present invention are herein described, by way of example only, with reference to the accompanying drawings, in which: Reference will now be made specifically to the drawings in detail, stressing that the particulars shown are for the purpose of illustrating and discussing embodiments of the invention by way of example, and in which the description made with the drawings will make apparent to those skilled in the art how embodiments of the invention may be practiced. [Brief description of the drawings]

[0068] [Figure 1a] 1 is an exemplary tricuspid valve replacement delivery system, according to some embodiments of the present invention. [Figure 1b] 1A-1C are two exemplary prosthetic valve implants, according to some embodiments of the invention. [Figure 1c] 1A-1C are two exemplary prosthetic valve implants, according to some embodiments of the invention. [Figure 1d] 1A-1C are two exemplary prosthetic valve implants, according to some embodiments of the invention. [Figure 1e] 1A-1D are two exemplary prosthetic valve implants, according to some embodiments of the present invention. [Diagram 2] 1A-1C are diagrams of an exemplary delivery catheter handle, according to some embodiments of the present invention. [Diagram 3] 1A-1D are diagrams of an exemplary elongate body, according to some embodiments of the present invention. [Figure 4] 1A-C are views of an exemplary implant housing / operating distal end, according to some embodiments of the present invention. [Diagram 5] 1A-B are diagrams of an exemplary implant holder, according to some embodiments of the present invention. [Figure 6a] 1A-1D are diagrams of an exemplary embodiment of an implant leg holder, according to some embodiments of the present invention. [Figure 6b] 1A-1D are diagrams of an exemplary embodiment of an implant leg holder, according to some embodiments of the present invention. [Figure 6c]1A-1D are diagrams of an exemplary embodiment of an implant leg holder, according to some embodiments of the present invention. [Figure 6d] 1A-1D are diagrams of an exemplary embodiment of an implant leg holder, according to some embodiments of the present invention. [Figure 6e] 1A-1D are diagrams of an exemplary embodiment of an implant leg holder, according to some embodiments of the present invention. [Figure 6f] 1A-1D are diagrams of an exemplary embodiment of an implant leg holder, according to some embodiments of the present invention. [Figure 6g] 1A-1D are diagrams of an exemplary embodiment of an implant leg holder, according to some embodiments of the present invention. [Figure 6h] 1A-1D are diagrams of an exemplary embodiment of an implant leg holder, according to some embodiments of the present invention. [Figure 6i] 1A-1D are diagrams of an exemplary embodiment of an implant leg holder, according to some embodiments of the present invention. [Figure 6j] 1A-1D are diagrams of an exemplary embodiment of an implant leg holder, according to some embodiments of the present invention. [Figure 6k] 1A-1D are diagrams of an exemplary embodiment of an implant leg holder, according to some embodiments of the present invention. [Figure 7] 1A-B are diagrams of an exemplary implant capsule / enclosure, according to some embodiments of the present invention. [Figure 8] 1A-C are views of different angles of an exemplary distal tip, according to some embodiments of the present invention. [Figure 9a] 11A-11D are diagrams of an exemplary steering action of a distal end of an elongate body, according to some embodiments of the present invention. [Figure 9b] 11A-11D are diagrams of an exemplary steering action of a distal end of an elongate body, according to some embodiments of the present invention. [Figure 9c] 11A-11D are diagrams of an exemplary steering action of a distal end of an elongate body, according to some embodiments of the present invention. [Figure 9d]12 is a diagram of an exemplary bending operation in zone 1204, according to some embodiments of the present invention. [Figure 9e] 12A-12C are diagrams of exemplary bending operations in both zone 1202 and zone 1204, according to some embodiments of the present invention. [Figure 9f] 11A-11D are diagrams of exemplary movement combinations of the distal end of the device, according to some embodiments of the present invention. [Figure 9g] 11A-11D are diagrams of exemplary movement combinations of the distal end of the device, according to some embodiments of the present invention. [Figure 9h] 1A-1C are schematic diagrams of motion definitions of a delivery device according to some embodiments of the present invention. [Figure 9i] 1A-1C are schematic diagrams of motion definitions of a delivery device according to some embodiments of the present invention. [Figure 10a] 1A-1D are diagrams of an exemplary quick release knob, according to some embodiments of the present invention. [Figure 10b] 1A-1D are diagrams of an exemplary quick release knob, according to some embodiments of the present invention. [Figure 11a] FIG. 2 is a diagram of an exemplary preparation procedure for a system according to some embodiments of the present invention. [Figure 11b] FIG. 2 is a diagram of an exemplary preparation procedure for a system according to some embodiments of the present invention. [Figure 11c] FIG. 2 is a diagram of an exemplary preparation procedure for a system according to some embodiments of the present invention. [Figure 11d] FIG. 2 is a diagram of an exemplary preparation procedure for a system according to some embodiments of the present invention. [Figure 11e] FIG. 2 is a diagram of an exemplary preparation procedure for a system according to some embodiments of the present invention. [Figure 11f] FIG. 2 is a diagram of an exemplary preparation procedure for a system according to some embodiments of the present invention. [Figure 11g] FIG. 2 is a diagram of an exemplary preparation procedure for a system according to some embodiments of the present invention. [Figure 11h]FIG. 2 is a diagram of an exemplary preparation procedure for a system according to some embodiments of the present invention. [Figure 11i] FIG. 2 is a diagram of an exemplary preparation procedure for a system according to some embodiments of the present invention. [Figure 11j] FIG. 2 is a diagram of an exemplary preparation procedure for a system according to some embodiments of the present invention. [Figure 11k] FIG. 2 is a diagram of an exemplary preparation procedure for a system according to some embodiments of the present invention. [Figure 11l] FIG. 2 is a diagram of an exemplary preparation procedure for a system according to some embodiments of the present invention. [Figure 11m] FIG. 2 is a diagram of an exemplary preparation procedure for a system according to some embodiments of the present invention. [Figure 11n] FIG. 2 is a diagram of an exemplary preparation procedure for a system according to some embodiments of the present invention. [Figure 11o] FIG. 2 is a diagram of an exemplary preparation procedure for a system according to some embodiments of the present invention. [Figure 12] 1A-1C are schematic diagrams of the path along which a delivery device moves during an implantation procedure, according to some embodiments of the present invention. [Figure 13a] 1A-1C illustrate an exemplary delivery method for an implant having legs of the same length, according to some embodiments of the present invention. [Figure 13b] 1A-1C illustrate an exemplary delivery method for an implant having legs of the same length, according to some embodiments of the present invention. [Figure 13c] 1A-1C illustrate an exemplary delivery method for an implant having legs of the same length, according to some embodiments of the present invention. [Figure 13d] 1A-1C illustrate an exemplary delivery method for an implant having legs of the same length, according to some embodiments of the present invention. [Figure 13e] 1A-1C illustrate an exemplary delivery method for an implant having legs of the same length, according to some embodiments of the present invention. [Figure 13f] 1A-1C illustrate an exemplary delivery method for an implant having legs of the same length, according to some embodiments of the present invention. [Figure 13g] 1A-1C illustrate an exemplary delivery method for an implant having legs of the same length, according to some embodiments of the present invention. [Figure 14a] 1A-1C illustrate an exemplary delivery method for an implant having legs of different lengths, according to some embodiments of the present invention. [Figure 14b] 1A-1C illustrate an exemplary delivery method for an implant having legs of different lengths, according to some embodiments of the present invention. [Figure 14c] 1A-1C illustrate an exemplary delivery method for an implant having legs of different lengths, according to some embodiments of the present invention. [Figure 14d] 1A-1C illustrate an exemplary delivery method for an implant having legs of different lengths, according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0069] The present invention, in some embodiments thereof, relates to valve delivery systems and associated methods, and more particularly, but not exclusively, to prosthetic valve replacement delivery systems and associated methods for the tricuspid valve.

[0070] overview An aspect of some embodiments of the present invention relates to manipulating a cardiac implant configured for placement in the heart during its deployment to facilitate positioning of the implant in the heart. In some embodiments, the cardiac implant is delivered into the heart in a compressed / crimped configuration in a delivery device. In some embodiments, the cardiac implant is first partially deployed to a first positioning while maintaining at least a portion of the cardiac implant in communication with the delivery device. In some embodiments, by maintaining at least a portion of the implant in communication with the delivery device, a user can make adjustments to the first positioning to provide a second positioning, which may be a required and / or desired positioning of the implant by the user. In some embodiments, once the cardiac implant is positioned, a user fully deploys the cardiac implant by releasing at least a portion of the cardiac implant from the delivery device. In some embodiments, the partial deployment of the cardiac device is a controlled deployment, meaning that the deployment is controlled by the user and / or the delivery device is configured to release the cardiac implant such that the expansion of the heart valve occurs in a predetermined direction and / or manner. In some embodiments, the degrees of freedom of the delivery device are pre-constrained to facilitate deployment of the cardiac implant by the user. In some embodiments, the delivery device is configured to bend at two or more points each in a predetermined direction to provide the delivery device with a distal end with a particular mobility. In some embodiments, the delivery system includes a distal end that includes multiple parts configured for transporting and releasing the cardiac implant. In some embodiments, the distal end includes a housing / operating distal end for the cardiac implant that is configured to maintain the cardiac implant in a compressed / crimped configuration until the time of deployment / partial deployment.

[0071] Before describing at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of components and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0072] Overview of an Exemplary Delivery System 1a illustrates an exemplary tricuspid valve replacement delivery system, according to some embodiments of the present invention. In some embodiments, the delivery system 100 includes a catheter 102 having a prosthetic valve 104 attached to a distal end of the catheter 102. In some embodiments, the catheter 102 includes a handle 106, an elongate body 108 extending from the distal end of the handle 106, and a manipulation distal end (also referred to as an implant housing) 110 located distal to the elongate body 108.

[0073] Exemplary Implants 1b-1e, two exemplary implants 112 are shown according to some embodiments of the present invention. To facilitate the following description, the exemplary implants 112 are shown in an open configuration, as shown in FIGS. 1b and 1d, and in a compressed / crimped configuration, as shown in FIGS. 1c and 1e. FIGS. 1b-1e show an incomplete implant where only the "skeleton" of the implant is shown. The scope of these figures is to identify the relevant parts involved in the deployment of the implant and in communication with the delivery system, which is helpful for understanding the present invention. Broadly speaking, the implant can be divided into three main parts: the anchor 120, the mid-body 122, and the legs 124. As shown, in some embodiments, in the open configuration, the anchor 120 is folded towards the mid-body 122, while in the crimped configuration, the anchor 120 is extended downward. It can also be seen that in some embodiments, in the open configuration, the mid-body 122 is wide open, whereas in the crimped configuration, the mid-body 122 is thin and narrow. In some embodiments, the difference between the implant shown in Figures 1b-1c and the implant shown in Figures 1d-1e is that the implant shown in Figures 1d-1e comprises two short legs 124 and one longer leg 126 (longer than the other two legs 124). In some embodiments, the length of the short leg is about 3 mm to about 5 mm, optionally about 2.5 mm to about 5.5 mm, optionally about 1 mm to about 6 mm. In some embodiments, the length of the long leg is about 1 mm to about 3 mm longer than the length of the short leg, optionally about 0.5 mm to about 3.5 mm longer, optionally about 0.3 mm to about 6 mm longer. The implant is made of a self-expanding and / or shape memory material, such as, for example, Nitinol, which allows the implant to be delivered by crimping, and once in place, the implant will return to its open configuration without further assistance while releasing the implant.

[0074] Exemplary Handle 106 Referring now to FIG. 2, an exemplary handle 106 of a delivery catheter according to some embodiments of the present invention is shown. FIG. 2 shows a side view of the exemplary handle 106. In some embodiments, the handle is disposed at a proximal end of the delivery system 100 and is operated from outside the patient's body. In some embodiments, the handle comprises a proximal end 202 and a distal end 204. In some embodiments, the handle comprises at least one actuation mechanism configured to actuate one or more of the movement of the elongate body 108 and / or the movement of the implant housing / operation distal end 110 and / or the movement of the outer / outer tube 302 and / or the movement of the inner / inner tube of the elongate body. In some embodiments, actuation of one or more of the movement of the elongate body 108 and / or the movement of the implant housing / operation distal end 110 and / or the movement of the outer / outer tube 302 and / or the movement of the inner / inner tube of the elongate body is manually actuated, and optionally the handle includes one or more actuators, such as an electric actuator and / or a pneumatic actuator. For example, the exemplary handle shown in FIG. 2 illustrates an exemplary handle in which movement of the elongate body 108 and / or movement of the implant housing / operating distal end 110 and / or movement of the outer / outer tube 302 and / or movement of the inner / inner tube of the elongate body are manually actuated. It should be understood that this example is provided to enable those skilled in the art to understand the present invention and is in no way limiting. In this example, the handle 106 includes three control knobs 206 / 208 / 210 (e.g., three rotation knobs) and one quick release knob 212 (see below for further details of the quick release knob 212). In this example, the rotation knobs 206 and 208 are used to control two different movements of the elongate body 108, and the rotation knob 210 is used to control the longitudinal movement of the elongate body 108. In some embodiments, the knobs 206 / 208 / 210 can alternatively be controlled and rotated by an electric drive motor. Additionally, in some embodiments, the main handle can alternatively remain stationary and a lead screw with an electric motor can be used to push or pull the inner tube.In some embodiments, the handle comprises an inlet / outlet tube 214 configured to allow for the insertion of liquid (e.g., saline) and extraction of liquid and possible gas bubbles (e.g., blood, or oxygen, or air) from the delivery system 100, and more specifically from the implant housing / operating distal end 110. It should be understood that the above-described mechanisms for controlling the delivery device and releasing the implant are exemplary mechanisms disclosed to enable one of ordinary skill in the art to understand the invention. Other mechanisms may be used and are within the scope of the invention.

[0075] Exemplary Elongated Body 108 3, an exemplary elongate body 108 is shown, according to some embodiments of the present invention. FIG. 3 shows a side view of an exemplary elongate body 108. In some embodiments, the catheter 102 comprises an elongate body 108 that extends from a distal end of the handle 106 to a proximal end of the implant housing / operating distal tip 110. In some embodiments, the elongate body 108 begins at the proximal end of the handle 106, communicates with a quick release knob 212 (see above and below), extends inside the handle 106, and exits the handle 106 at the distal end of the handle 106. In some embodiments, the elongate body 108 includes an outer flexible tube 302, optionally made of one or more of braided Pebax / PEEK / stainless steel. In some embodiments, the elongate body 108 includes one long inner flexible tube (not shown), optionally made of one or more of braided Pebax / PEEK / stainless steel. In some embodiments, the inner tube optionally includes two or more sections, a first section extending from the handle 106 to a certain distance of the elongate body 108, and a second section extending to the implant housing / operating distal end 110. In some embodiments, the second section is optionally covered with an envelope made from one or more of Pebax / PVC. In some embodiments, the first section is stiffer than the second section. In some embodiments, the first section is about 1% to about 10% stiffer than the second section. Optionally, about 0.5% to about 20% stiffer. Optionally, about 0.1% to about 50% stiffer. In some embodiments, the second section is more flexible than the first section. In some embodiments, the second section is about 1% to about 10% stiffer than the first section. Optionally, about 0.5% to about 20% stiffer. Optionally, about 0.1% to about 50% stiffer. In some embodiments, a potential advantage of having two inner tubes with different levels of stiffness is to provide a catheter 102 with a softer zone when needed and a stiffer zone when flexibility is not essential.In some embodiments, when a single inner tube is used, the inner tube includes zones with different stiffnesses to provide the delivery device with the strength and flexibility needed where and when needed. For example, an extruded Pebax tube with varying stiffness in the longitudinal cross section. In some embodiments, the rotation knob 210 (or other actuation mechanism, see above) actuates only the longitudinal movement of the outer tube 202 without moving the inner tube 204. In some embodiments, the rotation knob 210 (or other actuation mechanism, see above) actuates only the longitudinal movement of the inner tube without moving the outer tube 302. In some embodiments, the rotation knob 210 (or other actuation mechanism, see above) actuates the longitudinal movement of the inner tube in one direction and simultaneously actuates the longitudinal movement of the outer tube 302 in the opposite direction to the longitudinal movement of the inner tube. For example, the outer tube 302 moves proximally while the inner tube moves distally, and vice versa.

[0076] In some embodiments, the length of the elongate body is sufficient to reach the heart from outside the body via a femoral or jugular venous entry or another entry point.

[0077] In some embodiments, the elongate body 108 is fitted with a port 310 configured to be placed at an incision point on the patient's body (i.e., where the physician will make an incision on the patient) and remain in place. In some embodiments, this allows the catheter 102 to be moved within the port 310 without causing further damage to the blood vessel. In some embodiments, the port 310 is connected to an inlet / outlet tube 312 configured to insert or remove fluids from the blood vessel.

[0078] Exemplary Implant Housing / Operation Distal End 110 4a-4c, an exemplary implant housing / operating distal end 110 is shown, according to some embodiments of the present invention. FIG. 4a shows a side view of the exemplary implant housing / operating distal end 110 including a schematic implant 112 in a crimped configuration. FIG. 4b shows the schematic implant 112 in a crimped configuration outside the exemplary implant housing / operating distal end 110. It should be understood that the schematic implant 112 is shown to facilitate explanation of the delivery system 100 and is not intended to limit the present invention in any way. FIG. 4c shows a side view of the exemplary implant housing / operating distal end 110 with the schematic implant 112 removed for clarity of parts.

[0079] In some embodiments, the implant housing / operation distal end 110 comprises the following parts: a distal tip 400, an implant holder 402, a connector (not shown) between the implant holder 402 and the inner tube of the elongate body 108, and an implant capsule / enclosure 406 attached to the distal end of the outer tube 302. In some embodiments, the different parts are connected to each other via a screw / thread mechanism. A potential advantage of having screwed / threaded parts in some embodiments is that on the one hand a device is provided that is easier to install and / or equip by the user and on the other hand a more reliable device is provided during use since the parts are firmly connected to each other.

[0080] Exemplary Implant Holder 402 5a-5b, an exemplary implant holder is shown, according to some embodiments of the present invention. In some embodiments, the implant holder 402 comprises an implant leg holder 500 at a proximal end including an orifice 502 having an internally threaded wall, and a connector tube 504 including a threaded adapter 506 disposed at a distal end. In some embodiments, the orifice 502 is connected to a connector and thus configured to connect to the elongated body 108. In some embodiments, the threaded adapter 506 is configured to connect to the distal tip 400. In some embodiments, the material of the implant holder is one or more of PEEK / stainless steel.

[0081] 6a-6k, an exemplary embodiment of an implant leg holder 500 is shown, according to some embodiments of the present invention. Referring now to FIG. 6a, an exemplary configuration of a portion of an implant leg holder is shown, according to some embodiments of the present invention. In some embodiments, the implant leg holder comprises a proximally located head 602 and a distally located neck 604. In some embodiments, the head 602 of the implant leg holder 500 includes an orifice 502 configured to connect to a connector, and thus to connect to the elongated body 108, as disclosed above. In some embodiments, between an upper proximal portion 606 of the head 602 and a lower distal portion 608 of the head 602, there are one or more grooves 610 that surround the periphery of the head 602 in a generally axial direction of the head 602, hereinafter referred to as axial grooves. In some embodiments, the head further comprises one or more grooves 612 in a generally longitudinal direction of the head 602, hereinafter referred to as longitudinal grooves.

[0082] In some embodiments, both the axial and longitudinal grooves are configured to receive and hold at least a portion of one or more legs 124 / 126 of the implant 112. In Figs. 6a-6k, as an example, the implant leg holder includes two axial grooves (610a, 610b). In some embodiments, there may be one groove, or three grooves, optionally, depending on the type of implant used. In some embodiments, the longitudinal groove 612 is configured to receive at least a portion of the implant 112 arriving from a general distal direction (see the exemplary preparation procedure below for specific information). In some embodiments, when preparing the implant 112 for an implantation procedure, the user inserts the legs 124 / 126 into the longitudinal groove 612, and the legs are held in place by a combination of the axial groove 612 and the longitudinal grooves (610, 610a, 610b).

[0083] In some embodiments, the implant leg holder 500 includes a number of axial grooves 612 equal to the number of legs 124 of the implant 112. In some embodiments, the implant leg holder 500 includes multiple axial grooves 612 configured to allow for use of the same implant leg holder 500 but with different implants having different numbers of legs.

[0084] 6b-6e, there is shown an embodiment in which the implant leg holder 500 includes identical axial grooves 612, according to some embodiments of the present invention. In some embodiments, the implant leg holder 500 includes axial grooves 612 that are identical to each other. FIG. 6b shows a top view of the head 602 of the implant leg holder 500, showing the orifice 502 with an internally threaded wall and three identical axial grooves 612. FIG. 6c-6e show a side view showing the location of each identical axial groove 612 on the head 602 of the implant leg holder 500. In some embodiments, when the axial grooves 612 are identical to each other, only implants with legs of the same length can be used.

[0085] 6f, there is shown how the implant legs 124 are reversibly attached to the implant leg holder 500, according to some embodiments of the present invention. Figure 6f shows an implant 112 having legs 124 of the same length. In some embodiments, the legs are inserted into the longitudinal grooves 612 and held inside the axial grooves 610b.

[0086] 6g-6j, there is shown an embodiment in which an implant leg holder 500 comprises two identical axial grooves 612 and another two different axial grooves, according to some embodiments of the present invention. In some embodiments, the implant leg holder 500 comprises one or more identical axial grooves 612 configured to accommodate one or more legs 124 of an implant of the same length. In some embodiments, the implant leg holder 500 also comprises one or more axial grooves 902 / 904 different from the axial groove 612, configured to accommodate one or more legs 126 of an implant having a different length than the first one. FIG. 6g shows a top view of the head 602 of the implant leg holder 500, showing the orifice 502 with an internally threaded wall, the two identical axial grooves 612, and the two different axial grooves 902, 904. FIG. 6i-6j show a side view showing the location of each identical axial groove 612 on the head 602 of the implant leg holder 500. 6h shows a side view showing two axial grooves 902 and 904, where groove 902 is the lower axial groove and in this example groove 902 is wider than axial groove 612 but has the same height as axial groove 612. Groove 904 is located higher than groove 902 and in this example groove 904 has the same width as axial groove 612 but is located higher than axial groove 612. In some embodiments, different types of legs 124 / 126 and / or different types of axial grooves 612, 902, 904 are used to provide directional configurations for attachment of the implant 112 to the implant leg holder 500 (see below).

[0087] 6k, there is shown how an implant 112 with two short legs 124 and one long leg 126 is reversibly attached to an implant leg holder 500, according to some embodiments of the present invention. FIG. 6k shows an implant 112 with two short legs 124 and one long leg 126. In some embodiments, as shown on the right side of the figure, the short legs are inserted into longitudinal groove 612 and held in axial groove 610b, while the long leg 126 is inserted into longitudinal groove 902, passes through axial groove 610b, and is also inserted into longitudinal groove 904 (located higher than longitudinal groove 902) and held in axial groove 610a, as shown, for example, on the left side of the figure.

[0088] Exemplary Implant Capsule / Enclosure 406 7a-7b, an exemplary implant capsule / enclosure 406 is shown, according to some embodiments of the present invention. FIG. 7a shows a side view of the exemplary implant capsule / enclosure 406, and FIG. 7b shows a perspective view of the exemplary implant capsule / enclosure 406. As mentioned above, at the distal end of the inner tube of the elongate body 108, there is a connector, optionally configured as a "male" threaded extension, configured to be used to connect with the head 602 of the implant holder 402. The "male-female" threaded configuration is merely one example, and other connector configurations may be used to connect the implant holder 402 and the inner tube of the elongate body 108, such as a push-pull connector, a bayonet (or reverse bayonet) coupling connector, to name a few. In some embodiments, the implant holder 402 is covered by the implant capsule / enclosure 406. In some embodiments, the proximal end 1002 of the implant capsule / enclosure 406 is irreversibly connected to the outer tube 302 of the elongate body 108. In some embodiments, the implant capsule / enclosure is made of a transparent material such as Nylon / Pebax / PEEK. In some embodiments, the length of the implant capsule / enclosure 406 is the same length as the implant holder 402, which is the same length as the crimped configuration of the implant 112. In some embodiments, the length of the implant capsule / enclosure 406 is about 45 mm to about 60 mm, optionally about 40 mm to about 70 mm, and optionally about 30 mm to about 80 mm. In some embodiments, the inner diameter of the implant capsule / enclosure 406 is about the same as or larger than the implant holder 402 including the crimped configuration of the implant 112. In some embodiments, the inner diameter of the implant capsule / enclosure 406 is from about 9 mm to about 10 mm, optionally from about 8 mm to about 12 mm, optionally from about 7 mm to about 15 mm, e.g., 9 mm, 9.7 mm, 10.5 mm, etc. In some embodiments, the capsule is transparent.In some embodiments, a potential advantage of having a transparent capsule is that the loading process of the implant into the capsule can be monitored.

[0089] Exemplary Distal Tip 400 8a-8c, different angles of an exemplary distal tip 400 are shown, according to some embodiments of the present invention. In some embodiments, the distal tip 400 comprises the following parts: an atraumatic distal tip 1102 and a distal tip base 1104. In some embodiments, the distal tip base 1104 comprises an orifice 1106 having an internally threaded wall and configured to connect to a threaded adapter 506 located at the distal end of the implant holder 402. In some embodiments, other techniques are used, such as, for example, snap attachment. In some embodiments, the distal tip base 1104 is made of one or more of PEEK / Pebax / stainless steel. In some embodiments, the atraumatic distal tip 1102 is made of one or more of Silicone / Pebax. In some embodiments, the distal tip base 1104 includes a groove 1108 configured to match the distal end 1004 of the implant capsule / enclosure 406 and enable the interior space of the implant capsule / enclosure 406 to be tightly, optionally hermetically, closed.

[0090] Exemplary steering movements of the distal end of the elongate body 9a-9c, an exemplary steering action of the distal end of the elongate body is shown, according to some embodiments of the present invention. In some embodiments, the distal end of the elongate body 108 includes one or more unidirectional steering zones, i.e., zones within the elongate body 108 where the elongate body is bent in one direction. In some embodiments, the elongate body includes two steering zones, one steering zone 1202 proximal to the implant housing / operation distal end 110 and another steering zone 1204 proximal to the steering point 1202. In some embodiments, one steering zone is bent in one direction and the other steering zone is directed in the opposite and / or different direction. Now, referring to FIG. 9b, a schematic diagram of the distal portion of the device is shown with a virtual angle gauge to help explain the direction of movement of the elongate body 106 relative to the general longitudinal line LL when the device is viewed from the side. The black dots 1206 represent the general bending and / or bending points of the device. For example, when the distal end of the device is bent upward, as shown by arrow 1208, it means that the device moves from 180° to 140° from 0°, as shown by the angle gauge. In another example, when the device is bent downward, as shown by arrow 1210, it means that the device moves from 180° to -110° from 0°, as shown by the angle gauge. In a final example, when the device is bent downward, as shown by arrow 1212, it means that the device moves from 180° to -20° from 0°, as shown by the angle gauge.

[0091] 9c, an exemplary bending action in zone 1202 is shown, according to some embodiments of the present invention. In some embodiments, distal zone 1202 bends downward along arrow 1302. In some embodiments, the bending angle is about 180° (or -180°) to about -0° (meaning the distal end rotates back towards the elongate body), optionally about 180° (or -180°) to about -20°, and optionally about 180° (or -180°) to about -50°. In some embodiments, the movement of distal zone 1202 is actuated by an actuation mechanism in handle 106, for example by actuating control knob 206. In some embodiments, bending distal zone 1202 creates an inner distal bending zone 1214 and an outer distal bending zone 1216, as shown by the arrows in FIG. 9c.

[0092] 9d, an exemplary bending action in zone 1204 is shown, according to some embodiments of the present invention. In some embodiments, proximal zone 1204 bends upward along arrow 1402. In some embodiments, the bending angle is from about 180° (or -180°) to about 0° (meaning the distal end rotates back towards the elongate body), optionally from about 180° (or -180°) to about 20°, and optionally from about 180° (or -180°) to about 50°. In some embodiments, the movement of proximal zone 1204 is actuated by an actuation mechanism in handle 106, for example by actuating control knob 208.

[0093] In some embodiments, bending the proximal zone 1204 creates an inner proximal bend zone 1218 and an outer proximal bend zone 1220, as shown by the arrows in FIG. 9d.

[0094] 9e, there is shown an exemplary bending motion in both zone 1202 and zone 1204, according to some embodiments of the present invention. In some embodiments, a combination of motion of distal zone 1202 (indicated by arrow 1502) and proximal zone 1204 (indicated by arrow 1504) provides a device that can bend as shown in FIG.

[0095] 9f and 9g, an exemplary combination of movements of the distal end of the device is shown, according to some embodiments of the present invention. In some embodiments, the device is first bent, as shown in FIG. 9f, by, for example, actuating the control knob 206 to bend the distal zone 1202 downward along arrow 1602 to an exemplary angle of -90°. At the end of the bending motion, the distal end of the device (marked as 1604) is "pointing down" at a relative height h1. Next, the proximal zone 1204 is bent upward by actuating the control knob 208, for example, along arrow 1606, while simultaneously continuing to actuate the control knob 206 to continue to bend the distal zone 1202 downward along dashed arrow 1608, thereby maintaining the distal end of the device "pointing down". At the end of the bending motion, the distal end of the device (marked as 1604) is still "pointing down", but this time at a relative height h2. The difference between the relative heights h1 and h2 is denoted as δh. In some embodiments, the combination of movements allows the device to first "point down" after bending at about -90°, and then "move up" while still "point down."

[0096] In some embodiments, the combination of movement of both bending positions allows for the specific movement required of the delivery device inside the heart to deliver the cardiac implant to the correct position (see Figures 14a-g and 15a-d and associated discussion).

[0097] 9h-9i, a schematic diagram of a definition of a movement of a delivery device is shown, according to some embodiments of the present invention. In some embodiments, a way to describe the movement of a delivery system is to imagine two imaginary points (1702 and 1704) on the shaft of the delivery device, for example as shown in FIG. 9h. In some embodiments, a virtual chord having a length (x) can be established between points 1702 and 1704. In some embodiments, a bending action of the shaft at two locations shortens the virtual chord, resulting in a shorter length (>x), for example as shown in FIG. 9i. In some embodiments, the manipulation of the shaft by bending the shaft at one or more locations is defined as the action required to shorten the virtual chord created by the two imaginary points located on the shaft of the delivery device.

[0098] Exemplary Steering Mechanism In some embodiments, an exemplary steering mechanism includes introducing rings and cables during the manufacturing process of the tube. In some embodiments, pulling and / or pushing and / or releasing the cables (e.g., by actuating a knob on a handle) causes the tube to bend at the location where the ring is located within a particular tube. In some embodiments, these steering mechanisms used are known in the art, and variations of the steering mechanisms are within the scope of the present invention.

[0099] Exemplary Proximal / Distal Movements of Elongated Body 108 In some embodiments, the outer tube 302 is configured to move proximally or distally while the inner tube is stationary. In some embodiments, the proximal / distal movement is controlled by a control knob 210 disposed, for example, on the handle. In some embodiments, rotating the control knob 210 in one direction moves the outer tube 302 forward (e.g., distally) and rotating the control knob 210 in the other direction moves the outer tube 302 backward (e.g., proximally).

[0100] In some embodiments, distal / proximal movement moves the outer tube 302 distally or proximally, and since the implant capsule / enclosure 406 is irreversibly connected to the outer tube 302, moving the outer tube 302 proximally while keeping the inner tube stable exposes the implant holder, as further described below in the "Exemplary Implantation Procedure."

[0101] Exemplary quick release knob 212 10a-b, an exemplary quick release knob 212 is shown according to some embodiments of the present invention. In some embodiments, the inner tube terminates at the proximal end of the handle 106. In some embodiments, the proximal end of the handle 106 also has a quick release knob 212 disposed thereon, connected to the proximal end of the inner tube. In some embodiments, the quick release knob 212 can be opened, e.g., by pulling proximally (see arrow 1802), as shown, e.g., in FIG. 10a, to allow a user to easily rotate the inner tube to the right or left along the inner tube's longitudinal axis, as indicated by the circular arrow 1804. In some embodiments, the quick release knob 212 can be closed, e.g., by pulling distally (see arrow 1806), as shown, e.g., in FIG. 11b, to allow a user to lock the inner tube so that it cannot be rotated to the right or left along the inner tube's longitudinal axis, as indicated by the "prohibited" symbol 1808. In some embodiments, rotation of the inner tube does not rotate the outer tube 302 and / or the implant capsule / enclosure 406. In some embodiments, an exemplary quick release knob allows a user to move the inner tube of the delivery device distally and / or proximally without moving the outer tube. In some embodiments, a potential advantage of this mechanism is that it allows a user to move the implant holder (including the implant) distally and proximally without having to move the outer tube and / or the implant capsule / enclosure. In some embodiments, this is useful as it allows a user to quickly reinsert the implant into the capsule / enclosure if necessary during implant deployment.

[0102] Exemplary Preparation Procedure 11a-11o, an exemplary preparation procedure for a system according to some embodiments of the present invention is shown. In some embodiments, preparation of the system begins by reversibly attaching an anchor 120 to an anchor holder rod 1202. In some embodiments, the anchor 120 is attached to the anchor holder rod 1202 by pulling down on the anchor 120, thereby placing the anchor 120 in an open configuration, for example as shown in FIG. 11a. FIG. 11b shows the anchor holder rod 1202 with an implant 112 attached to its distal end. The proximal end of the anchor holder rod 1202 is inserted into a two-part funnel 1204a / 1204b, the top of which is numbered 1204a and the bottom is numbered 1204b. FIG. 11c shows the anchor holder rod 1202 with the implant 112 in the two-part funnel 1204a / 1204b. Next, the helper rod 1206 is inserted into the orifice 502 of the implant leg holder 500 of the implant holder 40, as shown, for example, in FIG. 11d. The threaded adapter 506 is then screwed onto the head of the anchor holder rod 1202. The anchor holder rod 1202 is then pulled further down, so that the remaining part of the implant 112 contacts the inner wall of the top 1204a of the funnel and closes on its own as it is pulled down, as shown, for example, in FIG. 11e. FIG. 11e also shows that, at the square 1220, the leg 124 of the implant 112 coincides with the implant leg holder 500 when it reaches the narrowest part of the top 1204a of the funnel. At this point, the user inserts the leg 124 into the dedicated groove 612, as shown, for example, in FIG. 6b. Once insertion of the legs 124 into the grooves 612 of the implant leg holder 500 is complete, the user removes the helper rod 1206 and separates the upper and lower funnel portions 1204a, 1204b, as shown, for example, in FIG. 11f. At this point, the implant 112 is crimped and ready for insertion into the delivery device 100.The user moves the crimped implant 112 held by the anchor holder rod 1202 and the funnel bottom 1204b closer to the distal end of the delivery device 100, as shown, for example, in FIG. 11g. The user then moves the outer tube 302 (with the implant capsule / enclosure 406) backwards (proximally), for example, by rotating the control knob 210, thereby exposing the inner tube and connector, as shown, for example, in FIG. 11h. The user then connects between the connector located at the distal end of the inner tube and the orifice 502 in the implant leg holder 500 of the implant holder 402, as shown, for example, in FIG. 11i. The user then rotates the knob 210 in the other direction to move the outer tube 302 (with the implant capsule / enclosure 406) forwards (distally), thereby covering the implant holder 402 containing the implant 112 with the implant capsule / enclosure 406, as shown, for example, in FIG. 11j. Once the implant holder 402 with the implant 112 is fully positioned within the implant capsule / enclosure 406, the user removes the anchor 120 and threaded adapter 506 from the anchor holder rod 1202, which releases the implant holder 402 with the implant 112, which then sits within the implant capsule / enclosure 406, as shown, for example, in FIG. 11k. Once the implant holder 402 with the implant 112 is within the implant capsule / enclosure 406, as illustrated in FIG. 11l, the user brings the distal tip 400 in, for example, as shown in FIG. 11m. Finally, the user attaches the threaded adapter 506 of the implant holder 402 to the orifice 1106 of the distal tip base 1104 at the distal tip 400.

[0103] Referring now to FIG. 11o, to facilitate understanding of the delivery system 100 according to some embodiments of the present invention, various portions of the delivery system 100 are shown in an exploded perspective view and how they connect to each other.

[0104] Exemplary Transplantation Procedure 12, a schematic diagram of the path along which a delivery device operates during an implantation procedure is shown, according to some embodiments of the present invention. In some embodiments, during an implantation procedure, a delivery device is inserted, for example, via the patient's jugular vein 2602 and introduced directly into the right atrium 2604 of the heart. To implant the device into the tricuspid valve 2606 between the right atrium 2604 and the right ventricle 2608, the delivery device needs to be rotated, for example, as shown by the black arrow 2610 in FIG. 12. This non-linear access to the tricuspid valve 2606 is known to increase the difficulty of implanting the device in the correct position during implantation. A potential advantage of the delivery system 100 disclosed herein is that it allows the user to overcome the anatomical difficulties of the heart by providing an easy to maneuver delivery device that not only allows easy access to the correct position, but also allows the user to modify the position of the device after it has been deployed.

[0105] 13a-g, an exemplary delivery method for an implant with legs of equal length is shown, according to some embodiments of the present invention. In some embodiments, the device is introduced into the right atrium 2604, for example as shown in FIG. 13a. The user then bends the distal zone 1202 towards the tricuspid valve 2606 and through the tricuspid valve 2606 towards the right ventricle 2608, for example as shown in FIG. 13b. The user then actuates the bending of the proximal zone 1204, thereby pulling the distal end of the delivery device upwards, centering it in the middle of the tricuspid valve 2606, and moves it upwards (as described in FIG. 9g-h) a distance δh from h1 to h2, for example as shown in FIG. 13c, and actuates the bending of the device, for example as shown in FIG. 9a-f. Once in place, the user actuates the outer tube 302 to move posteriorly (see black arrow) while keeping the inner tube in place, thereby beginning to release the anchor 120 and causing it to begin to fold back behind the tricuspid valve 2606, as shown, for example, in FIG 13d. The user continues to actuate the outer tube 302 to move posteriorly (see black arrow) while keeping the inner tube in place, thereby completing the release of the anchor 120. The anchor 120 has now fully folded back behind the tricuspid valve 2606 within the right ventricle 2608, as shown, for example, in FIG 13e. In some embodiments, if the implant 112 includes three legs 124 of equal length, as shown, for example, in Figures lb-lc and 6f, when the legs 124 are released from the implant leg holder 500 in the right atrium 2604, the implant 112 returns to an open configuration (e.g., as shown in Figure lb) and rests over the tricuspid valve 2606 between the right atrium 2604 and the right ventricle 2608, as shown, for example, in Figure 13f. The delivery device can then be withdrawn from the heart and the patient, leaving the implant 112 in place, as shown, for example, in Figure 13g.

[0106] 14a-14d, an exemplary delivery method of an implant with legs of different lengths is shown, according to some embodiments of the present invention. FIG. 14a is the same as FIG. 13e, in which the user continues to actuate the outer tube 302 to move backwards (see black arrows) while keeping the inner tube in place, thereby completing the release of the anchor 120. The anchor 120 is fully folded back behind the tricuspid valve 2606 within the right ventricle 2608. In this embodiment, the implant comprises two short legs 124 attached to the lower groove 612 and axial groove 610b (as illustrated in FIG. 6k) and one long leg attached to the upper groove 904 and axial groove 610a. Thus, the user continues to actuate the outer tube 302 to move backwards while keeping the inner tube in place until the axial groove 610b is outside the implant capsule / enclosure 406, thereby releasing the short leg 124 while retaining the long leg 126 within the axial groove 610a in the implant capsule / enclosure 406 (see enlarged box, for example, as shown in FIG. 14b). In some embodiments, due to the anatomy of the heart, the orientation of the implant in the crimped configuration is not normally aligned with the orientation of the tricuspid valve 2606. In some embodiments, due to the configuration provided by the long leg 126 and the axial groove 610a in the implant capsule / enclosure 406, once the short leg 124 is released, the partially deployed implant aligns itself with the tricuspid valve 2606 while retaining the long leg 126.

[0107] In some embodiments, the position of the long leg 126 and axial groove 610a in the implant capsule / enclosure 406 is manipulated relative to the distal bend zone of the delivery device until the long leg 126 and axial groove 610a are aligned with the inside 1214 of the distal bend zone 1202 (see FIG. 9c). In some embodiments, as previously described, the user can actuate, for example, a quick release to rotate the inner tube without moving the outer tube. In some embodiments, once the device is bent to deliver the implant to the tricuspid valve 2606, the user actuates the quick release to rotate the inner tube, which also rotates the implant holder and therefore the implant, to position the long leg 126 and axial groove 610a in the implant capsule / enclosure 406 in the correct position, i.e., on the same side as the inside 1214 of the distal bend zone 1202 is located.

[0108] At this point, the user can actuate the distal zone 1202 and / or the proximal zone 1204 to move the implant 112 and modify the position of the implant 112 within the tricuspid valve 2606. The user then continues to actuate the outer tube 302 to move rearward while keeping the inner tube in place until the axial groove 610a is outside the implant capsule / enclosure 406, thereby releasing the long leg 126 (see enlarged box) and releasing the implant 112 from the delivery device, as shown, for example, in FIG. 14c. The delivery device can then be withdrawn from the heart and the patient, leaving the implant 112 in place, as shown, for example, in FIG. 14d.

[0109] It is anticipated that many related tricuspid valve implants and delivery systems therefor will be developed during the life of any patents expiring from this application, and the scope of the terms "implant" and / or "delivery system" is intended to include a priori all such new technologies.

[0110] As used herein in reference to an amount or value, the term "about" means "within ±20% thereof."

[0111] The terms "comprises," "comprising," "includes," "including," "has," "having" and their conjugations mean "including, but not limited to."

[0112] The term "consisting of" means "including and limited to."

[0113] The term "consisting essentially of" means that a composition, method, or structure may include additional ingredients, steps, and / or moieties, but only if the additional ingredients, steps, and / or moieties do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0114] Throughout this application, embodiments of the invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Thus, the description of a range should be considered to specifically disclose all possible subranges as well as individual numerical values ​​within that range. For example, the description of a range such as "1 to 6" should be considered to specifically disclose subranges such as "1 to 3", "1 to 4", "1 to 5", "2 to 4", "2 to 6", "3 to 6", etc., as well as individual numerical values ​​within that range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0115] When a range of numerical values ​​is given herein (e.g., any pair of numerical values ​​joined by "10-15," "10 to 15," or another such range designator), it is meant to include any numerical value (fractional or integer) within the limits of the stated range, including the limits of the range, unless the context clearly dictates otherwise. The phrases "range / ranging / ranges between" a first designator and a second designator, and the phrases "range / ranging / ranges from" a first designator "to," "up to," "until," or "through" a second designator, are used interchangeably herein and are meant to include the first designator and the second designator, and all fractional and integer numbers therebetween.

[0116] Unless otherwise indicated, the numerical values ​​used herein and any numerical ranges based thereon are approximations within reasonable measurement precision and rounding errors that one of ordinary skill in the art would understand.

[0117] The term "method" as used herein refers to methods, means, techniques and procedures for accomplishing a given task, including but not limited to methods, means, techniques and procedures known to the practitioner of the chemical, pharmacological, biological, biochemical and medical arts or readily developed from known methods, means, techniques and procedures.

[0118] As used herein, the term "treating" includes preventing, substantially inhibiting, slowing, or reversing the progression of a condition, substantially ameliorating the clinical or cosmetic symptoms of a condition, or substantially preventing the appearance of clinical or cosmetic symptoms of a condition.

[0119] It is understood that certain features of the invention that are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination, or as appropriate in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be construed as essential features of those embodiments, unless the embodiment is inoperable without those elements.

[0120] While the present invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0121] All publications, patents, and patent applications mentioned in this specification are hereby incorporated by reference in their entirety to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference herein. Furthermore, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. Section headings, if used, should not be construed as necessarily limiting. Additionally, any priority document(s) of this application are hereby incorporated by reference in their entirety herein.

Claims

1. 1. A prosthetic heart valve delivery system comprising: a. an elongate body having a proximal end, a distal end, and at least two bent portions, the two bent portions having different bending directions; b. an inner tube disposed inside the outer tube, the inner tube having a proximal end and a distal end; c. a manipulation distal tip located at the distal end of the outer tube, the manipulation distal tip comprising: i. an implant holder reversibly attached to the distal end of the inner tube, the implant holder comprising at least two implant leg holders, one of which is configured to hold one of the legs in an axially more proximal position than the other; ii. an atraumatic distal tip connected to the distal end of the implant holder; iii. an implant enclosure externally surrounding the implant, the implant enclosure being connected proximate to the distal end of the outer tube and extending to a proximal end of the distal tip; the manipulation distal end comprising: d. a virtual chord defined between two locations adjacent the manipulation distal end, the virtual chord having a length, and actuating the at least two bends to shorten the length of the virtual chord results in the manipulation distal end being aligned ±20 degrees perpendicular to the opening of the heart valve.

2. 10. The delivery system of claim 1, wherein the bending portion is configured to bend to a bending angle of about 0 degrees to about 180 degrees.

3. 10. The delivery system of claim 1, wherein the elongate body is long enough to reach the patient's heart from outside the patient's body using a femoral or jugular venous entry point.

4. The delivery system of claim 1 , wherein the elongate body comprises a port that is positioned at an incision in a patient's body.

5. The delivery system of claim 4 , wherein the elongate body is configured to move along the port.

6. 5. The delivery system of claim 4, wherein the port comprises an inlet / outlet tube for inserting and removing fluids from a blood vessel.

7. The delivery system of claim 1 , wherein the inner tube is a single long tube.

8. 8. The delivery system of claim 7, wherein the single elongated tube includes multiple zones with different levels of stiffness.

9. The delivery system of claim 1 , wherein the inner tube comprises two or more sections.

10. 2. The delivery system of claim 1, wherein the inner tube comprises two portions, a first portion extending from the handle of the delivery system to a specific location on the elongate body, and a second portion extending from the specific location on the elongate body to the operative distal end.

11. The delivery system of claim 10 , wherein the second portion is surrounded by an envelope.

12. The delivery system of claim 10 , wherein the first portion is harder than the second portion.

13. The delivery system of claim 10, wherein the first portion is about 0.1% to about 50% harder than the second portion.

14. The delivery system of claim 10 , wherein the second portion is more flexible than the first portion.

15. The delivery system of claim 10, wherein the second portion is about 0.1% to about 50% softer than the first portion.

16. 10. The delivery system of claim 1, wherein the implant enclosure is sized and shaped to accommodate the prosthetic heart valve in a crimped configuration.

17. The delivery system of claim 1 , further comprising a handle at the proximal end of the elongate body for actuating the delivery system.

18. The actuating comprises: a. actuating the at least two bending portions; b. axially moving the elongate body; c. axially moving the inner tube; d. manually by actuating one or more knobs; e. Electronically by operating one or more motors; 10. The delivery system of claim 1, comprising one or more of:

19. 18. The delivery system of claim 17, wherein the handle comprises a quick release knob in communication with the elongate body, the quick release knob configured to rotate the elongate body along its longitudinal axis.

20. 18. The delivery system of claim 17, wherein the handle comprises inlet / outlet tubes configured to allow insertion / extraction of a substance from the delivery system.

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