CATHETER SYSTEM FOR SEQUENTIAL DEPLOYMENT OF EXPANDABLE IMPLANTS - Patent application

Abstract

Systems and methods are described for sequentially deploying prosthetic valves using a delivery catheter. The delivery catheter can include a deployment assembly including an end cone, a distal sleeve, a prosthetic support, an anchor sleeve, and an anchor support. The delivery catheter can further include a handle with a manipulator including a guide connected to the deployment assembly using a force transmission tube. The guide can have various channels for coupling with protrusions on the handle, and can be guided by the protrusions to sequentially deploy the prosthetic valves from the deployment assembly. For example, the guide can cause the distal sleeve to release the distal end of the prosthetic valve, followed by the anchor support to release the proximal end of the prosthetic valve.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 383,011, filed November 9, 2023, the entire contents of which are incorporated herein by reference. [Technical Field]

[0002] FIELD OF THE INVENTION The present invention relates generally to a catheter system for deploying cardiac implants. For example, systems and methods including a catheter system for precise sequential placement of a prosthetic heart valve are provided herein. [Background technology]

[0003] Medical technology has made efforts to treat or repair heart valve defects, such as aortic regurgitation or aortic stenosis, non-surgically, and therefore without invasive surgery, using transarterial interventional access via catheters. Transcatheter aortic valve replacement (TAVR) / transcatheter aortic valve intervention (TAVI) procedures are becoming more common. Various delivery and stent systems have been proposed, each with different advantages and disadvantages, and some of these can be introduced transarterially into a patient's body via a catheter delivery system.

[0004] However, with the medical devices known to date, the implantation procedure of the stent system to which the prosthetic heart valve is attached has proven to be relatively complicated, difficult, and expensive. Apart from the complex implantation of the prosthetic heart valve as a replacement for an inadequate or defective native heart valve, there is a fundamental risk with the medical devices used to date of incorrect positioning of the stent or prosthetic heart valve, which cannot be corrected without more extensive and invasive surgical intervention.

[0005] It is also considered a problem that when using systems already known from the state of the art, incorrect positioning of the prosthetic heart valve or the associated heart valve stent can often only be avoided if the cardiac surgeon or interventional cardiologist is particularly experienced.

[0006] Improved delivery catheter systems are described, for example, in U.S. Pat. No. 11,065,138 to Schreck, U.S. Pat. No. 11,147,669 to Straubinger, and U.S. Pat. No. 8,679,174 to Ottma, the entire contents of each of which are incorporated herein by reference.

[0007] There is a need for further and improved systems and devices for introducing sequentially expandable heart valve stents into a patient's body, positioning the stent at the desired implantation site, and reducing risk to the patient during implantation. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Patent No. 11,065,138 [Patent Document 2] U.S. Patent No. 11,147,669 [Patent Document 3] U.S. Patent No. 8,679,174 Summary of the Invention

[0009] Provided herein are catheter systems and methods for sequentially implanting prosthetic heart valves. The catheter system can be used to implant a prosthetic heart valve with arms that allow the prosthetic heart valve to be clipped onto the native valve. This attachment method allows the valve to be positioned within the heart without the need to sew the prosthetic valve to the heart. Currently, commercially available delivery catheters in the United States are unable to perform the sequential deployment required for such prosthetic valves. The delivery catheter described herein can be used to sequentially deploy prosthetic valves. The delivery catheter positions the prosthetic valve over the native valve and sequentially releases portions of the prosthetic valve before detaching from the delivery catheter. The delivery catheter allows for precise positioning of the prosthetic valve at the desired implantation site. The prosthetic valve can then be sequentially deployed in a controlled manner to improve precision and safety.

[0010] A catheter system for implanting a prosthetic heart valve, in one example, can include a delivery catheter including a proximal region and a distal region, the distal region sized and shaped to be advanced to an implantation site of the native heart valve, and including: i) a first sleeve configured to hold a first end of the prosthetic heart valve; ii) a second sleeve configured to hold a second end of the prosthetic heart valve; and iii) a stent holder configured to engage the prosthetic heart valve. The delivery catheter can include a handle coupled to a proximal region of the delivery catheter, a manipulator configured to rotate about an axis of the manipulator and move axially relative to the handle, and a guide coupled to the manipulator, the guide including at least a first channel and a second channel perpendicular to and connected to the first channel, the guide being in mechanical communication with the stent holder and the second sleeve, the first and second channels configured to receive a protrusion as it moves within the first and second channels, wherein movement of the protrusion along the first channel unlocks the manipulator, and movement of the protrusion along the second channel sequentially moves the second sleeve and the stent holder distally, thereby releasing the prosthetic heart valve.

[0011] The second channel can include a spring, which allows movement of the protrusion in a first direction and resists movement in a second direction opposite the first direction. The spring can have a cantilevered portion having a spring force. The cantilevered portion can be resilient. The first channel can be connected to a first end of the second channel. The guide can include a third channel connected to a second end of the second channel, the third channel configured to receive the protrusion after it moves within the second channel. The third channel can be perpendicular to the second channel.

[0012] The catheter system may further include a fourth channel perpendicular to and connected to the third channel. The fourth channel may be configured to lock the protrusion to prevent movement of the second sleeve and the stent holder. The catheter system may further include a fifth channel connected to the second channel and configured to allow the protrusion to bypass the spring, thereby allowing the protrusion to move in a second direction opposite the first direction. The fifth channel may include a sloped portion configured to guide the protrusion into the second channel.

[0013] A method for deploying a prosthetic heart valve using a catheter system including a handle and a delivery catheter coupled to the handle at a proximal end of the delivery catheter can, in one example, include advancing a distal end of the delivery catheter to an implantation site of a native heart valve, the distal end of the delivery catheter including the prosthetic valve in a collapsed delivery state, and rotating a manipulator engaged with the handle such that a protrusion coupled to the handle crosses a first channel of a guide disposed within the manipulator and enters a second channel of the guide perpendicular to and connected to the first channel, thereby unlocking the manipulator from mechanical communication with the distal end of the delivery catheter, the distal end of the delivery catheter being configured to: (i) rotate the manipulator so that a protrusion coupled to the handle crosses a first channel of a guide disposed within the manipulator and enters a second channel of the guide perpendicular to and connected to the first channel; (ii) a first sleeve fixed to the catheter, including a first opening at a distal end, and configured to hold a first end of the prosthetic heart valve; (ii) a stent holder disposed within the first sleeve, axially movable relative to the first sleeve, and configured to engage with the prosthetic heart valve; and (iii) a second sleeve coupled to the tip, axially movable relative to the first sleeve, including a second opening at a proximal end, and configured to hold the second end of the prosthetic heart valve, and to advance the manipulator axially from a proximal direction to a distal direction to cause the protrusion to cross the second channel, thereby sequentially moving the second sleeve and the stent holder distally, thereby releasing the prosthetic heart valve at the implantation site.

[0014] The method may further include advancing a sheath including a sheath marker band to the sinoaortic junction within the patient's heart, inserting a delivery catheter including a sealing ring marker band into the sheath, advancing the delivery catheter through the sheath until the sealing ring marker band aligns with the sheath marker band, and aligning a distal end of the delivery catheter with a native heart valve within the patient's heart. Aligning the distal end of the delivery catheter with the native heart valve within the patient's heart may include rotating a second manipulator engaged with the handle. The method may include aligning the distal end of the delivery catheter with a native coronary artery cusp in the patient's heart. The method may further include detaching a safety clip removably connected to the handle before rotating the manipulator.

[0015] The method may further include rotating the manipulator engaged with the handle a second time and advancing the manipulator axially from the proximal direction to the distal direction a second time. The second channel may further include a spring, and the protrusion moves along the second channel in a first direction through the spring, the spring resisting movement of the protrusion in a second direction opposite the first direction. The method may further include retracting the manipulator to move the protrusion along the second channel in a second direction of the guide and into a third channel connected to the second channel, thereby bypassing the spring. The protrusion may bypass the spring by moving along a ramp in the third channel.

[0016] The method can further include rotating the manipulator to cause the protrusion to traverse the second channel in a second direction. [Brief explanation of the drawings]

[0017] [Figure 1] 1 illustrates an exemplary delivery catheter including a deployment assembly and a handle, according to some aspects of the present invention.

[0018] [Figure 2] 1 shows a perspective view of an exemplary handle of a delivery catheter.

[0019] [Figure 3] 1A and 1B show perspective views of an exemplary handle deployment assembly of a delivery catheter.

[0020] [Figure 4] 1 illustrates a cross-sectional view of an exemplary deployment manipulator.

[0021] [Figure 5] 1 illustrates a perspective cross-sectional exploded view of an exemplary deployment manipulator.

[0022] [Figure 6A] 1 illustrates a perspective view of an exemplary deployment guide within a deployment manipulator. [Figure 6B] 1 illustrates an enlarged perspective view of an exemplary portion of a deployment guide.

[0023] [Figure 7A] 10A-10C illustrate a series of deployment configurations of an exemplary deployment guide and corresponding cardiac prosthesis deployment. [Figure 7B] 10A-10C illustrate a series of deployment configurations of an exemplary deployment guide and corresponding cardiac prosthesis deployment. [Figure 7C] 10A-10C illustrate a series of deployment configurations of an exemplary deployment guide and corresponding cardiac prosthesis deployment. [Figure 7D] 10A-10C illustrate a series of deployment configurations of an exemplary deployment guide and corresponding cardiac prosthesis deployment. [Figure 7E] 10A-10C illustrate a series of deployment configurations of an exemplary deployment guide and corresponding cardiac prosthesis deployment. [Figure 7F] 10A-10C illustrate a series of deployment configurations of an exemplary deployment guide and corresponding cardiac prosthesis deployment. [Figure 7G] 10A-10C illustrate a series of deployment configurations of an exemplary deployment guide and corresponding cardiac prosthesis deployment. [Figure 7H] 10A-10C illustrate a series of deployment configurations of an exemplary deployment guide and corresponding cardiac prosthesis deployment. [Figure 7I] 10A-10C illustrate a series of deployment configurations of an exemplary deployment guide and corresponding cardiac prosthesis deployment. [Figure 7J] 10A-10C illustrate a series of deployment configurations of an exemplary deployment guide and corresponding cardiac prosthesis deployment.

[0024] [Figure 8A] 10A-10C illustrate a series of deployment configurations of an exemplary deployment guide and corresponding loading of the deployment assembly. [Figure 8B] 10A-10C illustrate a series of deployment configurations of an exemplary deployment guide and corresponding loading of the deployment assembly. [Figure 8C] 10A-10C illustrate a series of deployment configurations of an exemplary deployment guide and corresponding loading of the deployment assembly. [Figure 8D] 10A-10C illustrate a series of deployment configurations of an exemplary deployment guide and corresponding loading of the deployment assembly. [Figure 8E] 10A-10C illustrate a series of deployment configurations of an exemplary deployment guide and corresponding loading of the deployment assembly. [Figure 8F] 10A-10C illustrate a series of deployment configurations of an exemplary deployment guide and corresponding loading of the deployment assembly. [Figure 8G] 10A-10C illustrate a series of deployment configurations of an exemplary deployment guide and corresponding loading of the deployment assembly. [Figure 8H] 10A-10C illustrate a series of deployment configurations of an exemplary deployment guide and corresponding loading of the deployment assembly. [Figure 8I] 10A-10C illustrate a series of deployment configurations of an exemplary deployment guide and corresponding loading of the deployment assembly. DETAILED DESCRIPTION OF THE INVENTION

[0025] The present invention relates to a catheter system for introducing an expandable heart valve stent into a patient's body. Specifically, the catheter system may include a catheter including a deployment assembly and a handle for inserting the expandable heart valve stent into the patient's body. The expandable heart valve may be used to treat heart valve abnormalities, particularly heart valve insufficiency or heart valve stenosis in a patient. The expandable heart valve stent may be housed in a deployment assembly at the distal end of the catheter, and the deployment assembly may be manipulated using a handle system to sequentially deploy the expandable heart valve stent.

[0026] The delivery catheter of the present invention is particularly well suited for the sequential deployment of prosthetic heart valves having arms that can clip onto the native valve, such as those described in U.S. Patent No. 11,154,398 to Straubinger, the entire contents of which are incorporated herein by reference. The delivery catheter can position the prosthetic heart valve over the native valve, release one set of arms of the prosthetic heart valve, thereby allowing partial expansion of the prosthetic heart valve, and release a second set of arms of the prosthetic heart valve, thereby allowing further expansion of the prosthetic heart valve before detaching the valve from the delivery catheter for full expansion.

[0027] To improve safety, the catheter system described herein allows for precise positioning and deployment of a prosthetic valve within the heart. The catheter system can include a delivery catheter with a manipulator and a guide in mechanical communication with a stent holder. The guide allows for sequential deployment of the prosthetic valve.

[0028] Referring now to FIG. 1 , an exemplary delivery catheter including a handle system with a guide for sequentially deploying a prosthetic heart valve is shown. As shown in FIG. 1 , the delivery catheter 100 can include a proximal end and a distal end. The proximal end of the delivery catheter 100 can include a handle 104. The handle 104 is shown in more detail in FIG. 2 . The distal end of the delivery catheter 100 can include a deployment assembly 102. The deployment assembly 102 is shown in more detail in FIG. 3 . The deployment assembly 102 and the handle 104 can be operably connected via a catheter portion 120. The catheter portion 120 can include a guidewire for guiding the deployment assembly 102 through a blood vessel to the heart and can further include one or more force transmission tubes, wires, cables, etc. that can translate movement of the handle 104 into movement in the deployment assembly 102.

[0029] The handle 104 can include a bending manipulator 114 used to bend the catheter portion 120, a rotation manipulator 116 used to rotate the deployment assembly about the longitudinal axis of the delivery catheter 100, and a deployment manipulator 118 used to manipulate the deployment assembly 102 to deploy the prosthetic heart valve. The bending manipulator 114 can be rotated to bend the catheter portion 120 into a U-shape to navigate the body's vasculature (e.g., the aortic arch). In one example, a cable or other force transmission device can extend from the bending manipulator 114 to the distal end of the deployment assembly 102 or catheter portion 120, and as the bending manipulator 114 is rotated, the length of the cable or force transmission device shortens, causing the distal end of the delivery catheter 100 to bend toward the handle 104.

[0030] The rotational manipulator 116 may be a handle that can be rotated about the longitudinal axis of the handle 104 to similarly rotate the deployment assembly 102 about the longitudinal axis of the delivery catheter 100. For example, the rotational manipulator 116 may be in mechanical communication with the deployment assembly 102 (e.g., via a force transmission tube), and rotation of the rotational manipulator 116 may similarly rotate the deployment assembly 102 (e.g., clockwise or counterclockwise).

[0031] The deployment manipulator 118 can include guides for sequentially manipulating the deployment assembly 102. The deployment assembly 102 can include the end cone 106, the distal sleeve 108, and the prosthesis holder 110. When the deployment manipulator 118 is manipulated (e.g., as described below with reference to Figures 7A-7J), the distal sleeve 108 and the stent holders on the prosthesis holder 110 can be manipulated in sequence to sequentially expand and release a prosthetic heart valve disposed on the deployment assembly 102.

[0032] The handle 104 may further include a safety clip 112 that may be removable and may be used to prevent the deployment manipulator 118 from advancing, thereby preventing the deployment assembly 102 from releasing the prosthetic heart valve. Additionally, the delivery catheter 100 may include ports 122 and 123 to allow for flushing of the catheter portion 120 and / or internal channels within the handle 104. Additionally, the delivery catheter 100 may include an introducer sheath 121 that may interface with the handle 104 and through which the catheter portion 120 may be positioned. In one example, the port 122 may be used to flush the introducer sheath 121.

[0033] To deliver the prosthetic heart valve to the implantation site, a sheath may first be placed in the patient's blood vessel and pushed into the patient's body until it reaches the heart. The delivery catheter 100 may be advanced through the sheath until it reaches the heart. Once the deployment assembly 102 is positioned in the patient's heart, the sheath may be fully or partially retracted. In one example, the sheath may be retracted before the delivery catheter 100 is removed from the patient's body.

[0034] The delivery catheter 100 may be threaded through the vascular system toward the heart and bent to conform to the shape of the vascular system. For example, the delivery catheter 100 may be introduced into an artery in a patient's leg, such as a transfemoral artery. In an embodiment, the delivery catheter 100 may be positioned in the transfemoral artery of the patient's leg. The delivery catheter 100 may then be pushed through the transfemoral artery until it reaches the heart. It is understood that such a procedure may include pushing the delivery catheter along the transfemoral artery and through the leg until the delivery catheter 100 curves around the top of the heart and reaches the aorta. Thus, when the deployment assembly 102 reaches the aorta, it may have rotated at least 90 degrees and be pointing in a generally opposite direction from when it first entered the patient's body through the patient's leg. In such a case, the bending manipulator 114 may cause the deployment assembly 102 to move in an arching manner.

[0035] Once the native valve (e.g., the aortic valve) is reached, the rotational manipulator 116 can be rotated about its axis. Specifically, as the rotational manipulator 116 rotates, the deployment assembly 102 can rotate in the same direction. The rotational manipulator 116 can allow for more controlled and precise angular movement to align the prosthetic valve with the native valve anatomy. In one example, the rotational manipulator 116 can have a button that allows for additional control and improved safety. For example, the rotational manipulator 116 can be locked to prevent movement.

[0036] The deployment manipulator 118 is configured to rotate about its axis and move axially relative to the handle 104. For example, a user can alternate between rotating and advancing the deployment manipulator 118 to sequentially deploy the prosthetic valve. The deployment manipulator 118 can be configured to use a guide to release the prosthetic valve in sequential steps. The deployment manipulator 118 and guide are described in more detail in Figures 4-5.

[0037] It will be understood that the delivery catheter 100 may be used to implant a prosthetic heart valve and / or other prosthetic devices, such as a stent. For example, the delivery catheter 100 may be used to sequentially deploy a prosthetic heart valve having a set of positioning arches and a set of retention arches. A user, such as a surgeon or cardiologist, can hold the handle 104 and manipulate the handle 104 to navigate the patient's cardiovascular system, ultimately sequentially expanding the prosthetic heart valve and clipping the prosthetic heart valve to the heart valve leaflets to secure the prosthetic heart valve to the native valve. In this manner, such a prosthetic heart valve can be implanted without the need for sewing to the heart.

[0038] Referring now to FIG. 2, a handle 200 is shown that may be the same as or similar to the handle 104 described above with respect to FIG. 1. The handle 200 may include a handle support 202, which may be and / or include a handle housing that a user can use to grip the handle 200 and / or any other handle portions. The handle support 202 may be connected to a bending manipulator 206, a rotation manipulator 208, and a deployment manipulator 210. The bending manipulator 206 may be the same as or similar to the bending manipulator 114. The rotation manipulator 208 may be the same as or similar to the rotation manipulator 116. The deployment manipulator 210 may be the same as or similar to the deployment manipulator 118.

[0039] 2, the handle 200 may further include a safety clip 204 that can be positioned between the rotation manipulator 208, the handle support 202, and / or the deployment manipulator 210. For example, the safety clip may be positioned between the handle support 202 and the rotation manipulator 208, although in other examples, the safety clip 204 may instead be positioned between the rotation manipulator 208 and the deployment manipulator 210. The safety clip 204 may interfere with movement of the rotation manipulator 208 and / or the deployment manipulator 210 and may need to be removed before deployment can begin. The handle 200 may further include a safety lock 207, which may be a switch that can lock the movement bend manipulator 206 in place and prevent movement of the bend manipulator 206 in another position.

[0040] The safety clip 204, bending manipulator 206, rotation manipulator 208, and deployment manipulator 210 may be shaped and sized to be grasped and easily manipulated by hand. For example, the safety clip 204, bending manipulator 206, rotation manipulator 208, and deployment manipulator 210 may have indentations, raised patterns, and / or grooves to improve a user's grip. The safety clip 204 may be shaped so that a user can easily pinch the safety clip 204 between two fingers. The bending manipulator 206, rotation manipulator 208, and deployment manipulator 210 may have a smaller diameter at their center than at their ends to improve a user's grip.

[0041] Referring now to FIG. 3 , the deployment assembly 300 is shown in more detail. The deployment assembly 300 may include an endocone 302, a distal sleeve 304, a taper assembly 306, a prosthesis support 305, a prosthesis holder 307, an anchor support 309, an anchor sleeve 308, a cone 311, and a catheter tube 301. The endocone 302 may be connected to the distal sleeve 304. For example, the endocone 302 and the distal sleeve 304 may be a single, continuous component or may be separate components connected or joined to one another. The endocone 302 and / or the distal sleeve 304 may be made, for example, from a plastic material having a resilient or compressible structure. The distal sleeve 304 may be open at the proximal end. The endocone 302 and / or the distal sleeve 304 may be connected to the anchor sleeve 308, which may be moved when the endocone 302 and / or the distal sleeve 304 reach a specific position.

[0042] The prosthetic support 305 and the taper assembly 306 may be coupled to one another. It is understood that the taper assembly 306 may include several slits and / or be made of a resilient material and may be compressible to allow the distal sleeve 304 to cross the apex of the taper assembly 306. A prosthetic device, such as a prosthetic heart valve, may be placed on the prosthetic support 305 and / or may abut against or be otherwise supported by the taper assembly 306. The prosthetic support 305 may be tubular in shape and may be coupled to an anchor support 309. The anchor support 309 may be coupled to a cone 311, which may be coupled to the catheter tube 301.

[0043] Anchor support 309 is sized and shaped to receive or otherwise engage a portion of a prosthetic device placed on prosthetic support 305. Anchor sleeve 308 may be a tubular sleeve that can extend over anchor support 309 such that the anchor sleeve completely covers anchor support 309, thereby securing an engaging portion of the prosthetic device to anchor support 309. Anchor sleeve 308 may optionally include locking structure 303, which can secure anchor sleeve 309 in place once anchor sleeve 309 is placed over anchor support 309. In one example, locking structure 303 can be released by an external tube (not shown), which can be placed over anchor sleeve 308. Cone 311 provides a gradual transition from the diameter of anchor sleeve 308 to the diameter of catheter 301 and can prevent damage to the patient's vasculature during implantation of the prosthetic device.

[0044] Referring now to FIG. 4, a cross-sectional view of a deployment manipulator 400 is shown. The deployment manipulator 400 may be the same as or similar to the deployment manipulator 118. The deployment manipulator 400 may be connected to a handle support 402, which may connect the deployment manipulator 400 to the remainder of a handle (e.g., handle 104 of FIG. 1). The handle support 402 may be tubular in shape and / or may be or include one or more handle portions. The handle support 402 may include a protrusion 405. The protrusion 405 may be located at the distal end of the handle support 402 and / or at any other location on the handle support 402. The protrusion 405 and / or any other protrusion described herein may be any type of protrusion or pin that can extend outward from a surface of the handle support 402. The deployment manipulator 400 may be designed to accommodate the handle support 402. The deployment manipulator 400 may be securely attached to a force transmission tube 408 that extends through the handle and catheter and can connect to a deployment assembly (e.g., deployment assembly 102 of FIG. 1 ). It is understood that the force transmission tube 408 may be any known force transmission structure (e.g., a cable, a tube, a rod, etc.). The force transmission tube 408 may be coupled to the housing 404 of the deployment manipulator 400 such that axial motion of the deployment manipulator 400 can be translated to the force transmission tube 408, but rotational motion cannot be translated.

[0045] Axial movement of the force transmission tube 408 can sequentially move a distal sleeve (e.g., distal sleeve 304 of FIG. 3 ) and an anchor sleeve (e.g., anchor sleeve 308) of the deployment assembly. The deployment manipulator 400 can include a housing 404 that can include a guide 406. The guide 406 can receive the distal end of the handle support 402, which may be bifurcated and include a protrusion 405 and a series of channels for receiving the deployment manipulator 400 and moving axially relative to the protrusion 405 and the handle support 402.

[0046] FIG. 5 is an exploded cross-sectional view of a deployment manipulator 500. The deployment manipulator 500 may be the same as or similar to the deployment manipulator 400. As shown in FIG. 5, only half of the deployment manipulator 500 is shown. Similar halves (not shown) can be connected to the components shown in FIG. 5 to form the complete deployment manipulator 500, although it is understood that the half not shown may not have the channel 505. It is understood that the term channel as used throughout may refer to, for example, any channel and / or guide structure. It is further understood that the channel may be one or more recesses and / or may protrude outward from a surface. The deployment manipulator 500 may include a housing 502, which may be a cylindrical shell and may further include a guide 504. The housing 502 may be configured to be easily held and manipulated by a user and may have a central portion with a smaller diameter than the proximal and distal ends.

[0047] The guide 504 may be designed to be disposed within and secured to the housing 502. The housing 502 may be further secured to a force transmission tube (e.g., force transmission tube 408 in FIG. 4 ). For example, the housing 502 may include an inwardly protruding groove 506, and the guide 504 may include a groove-receiving portion 509 that is dimensioned to receive the groove 506 and retain the guide 504 within the housing 502. The guide 504 may be further secured to the housing 502 via any other known fastening technique (e.g., adhesive, threaded engagement, welding, etc.).

[0048] The deployment manipulator 500 has a proximal end 508 and a distal end 510. The proximal end 508 can receive a handle support (e.g., the handle support of FIG. 402). The distal end 510 can be sized and shaped to engage a force transfer tube (e.g., the force transfer tube 408 of FIG. 4). The guide 504 can further include a channel 505, which can be sized to receive and guide a protrusion (e.g., the protrusion 402 of FIG. 4) along the channel 505. FIGS. 6-8 show in more detail how movement of the protrusion along the guide 504 enables sequential deployment of the prosthetic valve.

[0049] 6A-6B, a perspective view of guide 600 and a focused view of spring 618 are shown. Guide 600 may be the same as or similar to guide 504 of FIG. 5. As shown in FIG. 5, guide 600 may include various protrusion guide channels, which may be, for example, recessed grooves within guide 600 for receiving protrusions. In one example, guide 600 may include locking channel 606, delivery channel 608 including spring 618, storage channel 610, bypass channel 612, and angled channel 614 including angled portion 616. The various channels may be sized to receive the protrusions and allow them to traverse the channels. In this manner, a deployment manipulator may guide and move the protrusions along locking channel 606 and into delivery channel 608, resulting in sequential deployment of the prosthetic valve.

[0050] The protrusion may begin at locking channel 600, which can provide a space for the protrusion to rest in before deployment. In this position, the prosthetic valve may be held by the delivery catheter while the protrusion is within locking channel 606. To prepare the deployment manipulator for deployment of the prosthetic valve, the user must rotate the deployment manipulator to have the protrusion cross locking channel 606 and guide the protrusion into delivery channel 608.

[0051] The locking channel 606 may be perpendicular to and connected to the delivery channel 608. The locking channel 606 may be perpendicular to the longitudinal axis of the deployment manipulator, and the delivery channel 608 may be parallel to the longitudinal axis of the deployment manipulator. Thus, the delivery channel 608 may be perpendicular to the locking channel 606. The protrusion can move from the locking channel 606 into the delivery channel 608 when the deployment manipulator rotates about its longitudinal axis.

[0052] As the deployment manipulator advances relative to the handle, the protrusion can be forced across the delivery channel 608. The delivery channel 608 can include a spring 618 along the delivery channel 608. The spring 618 can include a cantilevered portion 622 that allows movement along the delivery channel 608 in only one direction but can include an angled obstacle 620 at its distal end that resists movement of the protrusion in the opposite direction. For example, the protrusion can engage the angled obstacle 620 such that advancement of the protrusion along the delivery channel 608 creates a downward force on the cantilevered portion 622 of the spring 618, causing the cantilevered portion 622 of the spring 618 to deflect downward, allowing the protrusion to traverse the spring 618 and the delivery channel 608. It is understood that the cantilevered portion 622 can have a spring force that allows the cantilevered portion 622 to deflect elastically.

[0053] Once across the spring 618, the protrusion may not be able to move back toward the locking channel 606 because the angled obstacle 620 restricts movement in the opposite direction. For example, the angled obstacle 620 can be shaped so that movement in the opposite direction does not translate into a downward force on the cantilevered portion. Thus, the protrusion may only be able to move in one direction along the spring 618. Such limited movement aids in safety and precision, as spring forces can be strategically placed along the delivery channel 608 to provide tactile feedback indicating that a particular movement of the deployment assembly has been achieved. For example, the spring 618 may be strategically placed along the delivery channel 608 to indicate that the distal sleeve has released the distal portion of the prosthetic valve.

[0054] In addition to the locking channel 606, the delivery channel 608 may be connected to a storage channel 610, which may include a portion perpendicular to the delivery channel 608 and a portion parallel to the delivery channel 608. The storage channel 610 is configured to receive the protrusions while the delivery catheter is stored, i.e., not in use for transport or otherwise. The storage channel 610 allows the protrusions to be stored in a neutral position with the guide 600 prior to loading the prosthetic valve into the deployment assembly.

[0055] To load the prosthetic valve, the deployment manipulator can be advanced and then rotated to guide the protrusion from the storage channel 610 into the delivery channel 608. Once in the delivery channel 608, the deployment manipulator must be retracted relative to the handle to guide the protrusion along the delivery channel 608 toward the locking channel 606. As the protrusion advances along the delivery channel 608 toward the locking channel 606, it can be impeded by a spring 618.

[0056] 6B, an enlarged view of guide 600 including spring 618 and bypass channel 612 is shown in greater detail. As a protrusion is advanced along delivery channel 608 toward locking channel 606, spring 618 can be bypassed through the use of bypass channel 612. As shown in FIG. 6B, the bypass channel extends diagonally to form delivery channel 608 and provides a bypass path for the protrusion around spring 618. For example, a user can feel a tactile response from spring 618 and, in response, rotate the deployment manipulator to place the protrusion into bypass channel 612.

[0057] Once in bypass channel 612, the protrusion may then be guided into angled channel 614, which may be perpendicular to delivery channel 608. Angled channel 614 may include a sloped portion 616, which may be flush with angled channel 614 at one end and may extend upward toward delivery channel 608 such that sloped portion 616 terminates at a height higher than the floor of delivery channel 608. In this manner, sloped portion 616 may act as a wall of delivery channel 608 and prevent the protrusion from entering angled channel 614 as it traverses delivery channel 608 toward spring 618.

[0058] Thus, bypass channel 612 can allow the protrusion to bypass spring 618 and guide the protrusion into angled channel 614. Once the protrusion enters angled channel 614, the user can feel resistance to further advancement of the deployment manipulator and, in response, can rotate the deployment manipulator to cause the protrusion to climb ramp 616 and eventually re-enter delivery channel 608, thereby bypassing spring 618 including angled obstruction 620. Once re-entering delivery channel 608, the protrusion can traverse delivery channel 608 toward locking channel 606.

[0059] Manipulating the deployment manipulator, and thus the guide 600 relative to the protrusions, to deploy the prosthetic valve is described in more detail in Figures 7A-7J. Manipulating the deployment manipulator, and thus the guide 600 relative to the protrusions, to load the prosthetic valve into the deployment assembly of the delivery catheter is described in more detail in Figures 8A-8I.

[0060] 7A-7J, deployment of a prosthetic heart valve using a guide is illustrated. As shown in FIG. 7A, protrusion 702, which may be the same as or similar to protrusion 405 of FIG. 4, may begin at locking channel 704 of guide 700. Guide 700 may be the same as or similar to guide 600, and locking channel 704 may be the same as or similar to locking channel 606 of FIG. 6. Referring now to FIG. 7B, when protrusion 702 is in the locked position shown in FIG. 7A, prosthetic valve 706 may be fully retained by deployment assembly 300, which may be the same as or similar to deployment assembly 705 of FIG. 3. Deployment assembly 705 may include distal sleeve 707, which may be the same as distal sleeve 304 of FIG. 3, and anchor sleeve 709, which may be the same as anchor sleeve 308 of FIG. 3. As shown in FIG. 7B, prosthetic valve 706 may be retained at its proximal end by anchor sleeve 709 and an anchor support (not shown), or at its distal end by distal sleeve 707. In this manner, when 702 is within locking channel 704, prosthetic valve 706 can be fully compressed.

[0061] The position of the protrusions 702 may be ideal for advancing the prosthetic valve 706 through the patient's vasculature and into the patient's heart. Once the prosthetic valve 706 is properly aligned within the patient's heart, the protrusions 702 may be advanced toward the delivery channel 701. For example, a user may rotate the deployment manipulator to similarly rotate the guide 700. Deployment may also be hindered by a safety clip, which must be removed. Once the safety clip is removed, the protrusions 702 may move into the delivery channel 701.

[0062] 7C-7D, a user can begin deployment of the prosthetic valve 706 by advancing the protrusion 702 down the delivery channel 701. Using the deployment manipulator housing guide 700, the user can move the protrusion 702 across the guide 700 by pushing or pulling the deployment manipulator to move the protrusion 702 relative to the delivery channel 701 and away from the locking channel 704. As shown in FIG. 7D, advancing the protrusion 702 along the delivery channel 701 moves the distal sleeve 707 distally while the anchor sleeve 709 remains in place.

[0063] 7E-7F, as protrusion 702 continues to traverse delivery channel 701, protrusion 702 engages, deforms, and advances past spring 711, which may be the same as spring 618 in FIG. 6. Such manipulation provides the user with tactile input that transverse spring 711 is initially resisted and then released during deployment. As shown in FIG. 7F, spring 711 can be strategically positioned along delivery channel 701 so that transverse spring 711 aligns with distal sleeve 707 to fully release the distal end of prosthetic device 706, allowing distal end 712 to expand. As also shown in FIG. 7F, anchor sleeve 709 remains motionless in place while distal sleeve 707 fully releases distal end 712 of prosthetic valve 706.

[0064] 7G-7H, the complete release of the prosthetic valve 706 using the guide 700 is shown. As shown in FIG. 7G, the deployment manipulator can be used to continue to move the protrusions 702 across the delivery channel 701. Once the protrusions 702 cross the springs 711, the deployment manipulator can move the anchor supports 713 distally, thereby fully exposing the supports and fully expanding the proximal end of the prosthetic device 706, thereby fully releasing the prosthetic valve 706 from the deployment assembly. In this manner, the guide 700 can facilitate sequential deployment of the prosthetic valve, first releasing the distal end 712 and then the proximal end 715 of the prosthetic valve 706.

[0065] 7G-7H , once the guide 700 is used to fully release the prosthetic valve 706, the deployment manipulator can move the projection 702 rearward along the delivery channel 701 (i.e., toward the locking channel 704), and in doing so, the deployment manipulator can move the distal sleeve 707 proximally to engage a taper assembly 716, which may be the same as or similar to taper assembly 306. The taper assembly 716 can be compressed by the distal sleeve 707, such that the taper assembly 716 can begin to enter the distal sleeve 707.

[0066] Engagement of the distal sleeve 707 with the taper assembly 716 may be such that the taper assembly 716 can prevent damage to the patient's vasculature or other tissue from the open end of the distal sleeve 707. Additionally, referring again to FIG. 7I, the position of the spring 711 along the delivery channel 701 may be such that when the distal sleeve 707 achieves a desired placement on the taper assembly 716, movement of the protrusion 702 along the delivery channel 701 may be impeded by the spring 711.

[0067] Referring now to FIGS. 8A-8I, release of a prosthetic valve using a guide within a deployment manipulator is illustrated. As shown in FIG. 8A, protrusion 802, which may be the same as protrusion 702 in FIGS. 7A-7J, can traverse guide 800, which may be the same as guide 700 in FIGS. 7A-7J. Guide 800 can include a storage channel 804, which may be the same as storage channel 610, and can allow the deployment assembly to remain in a stored position (e.g., for transfer or storage). As shown in FIG. 8A, the delivery catheter can be transferred for prosthetic valve loading by forcing protrusion 802 to traverse storage channel 804 and enter delivery channel 801. Referring now to FIG. 8B, to prepare the deployment assembly to receive the prosthetic valve, the deployment manipulator can be pushed or pulled to cause protrusion 802 to traverse delivery channel 801 toward locking channel 818.

[0068] 8C-8D, a deployment assembly 850 is shown, corresponding to the movement of projection 802 in FIGS. 8A-8B. Deployment assembly 850 may be the same as or similar to deployment assembly 300 shown in FIG. 3. Deployment assembly 850 may include end cone 806, distal sleeve 826, taper assembly 827, prosthetic support portion 808, anchor sleeve 820, and anchor support portion 814, which may be the same as or similar to end cone 302, distal sleeve 304, taper assembly 306, prosthetic support portion 305, anchor sleeve 308, and anchor support portion 309, respectively.

[0069] 8C-8D , upon movement of the deployment manipulator to effect movement of the protrusions 802, the anchor support 814 can move distally, which in turn can move the distal sleeve 826. As the anchor support 814 moves distally, the proximal end of the prosthetic valve, which may include an anchor, can be positioned within the anchor support 814. Once the protrusions 802 traverse the delivery channel 801, the anchor support 814 can move proximally into the anchor sleeve 820, thus securing the proximal end of the prosthetic valve to the deployment assembly 850.

[0070] 8F-8I, the movement of guide 800 and deployment assembly 850 to secure the distal end of the prosthetic device is shown. As shown in FIG. 8F, upon manipulating guide 800 so that protrusion 802 engages spring 830, the user receives tactile feedback from spring 830 and, in response, can rotate and advance guide 800 so that protrusion 802 enters bypass channel 835 and then angled channel 840. The user can then rotate guide 800 so that protrusion 802 exits angled channel 840 (e.g., a sloped portion the same as or similar to sloped portion 616 in FIG. 6B) and enters delivery channel 801. At bypass spring 830, a distal sleeve can be advanced over the tapered assembly. In FIG. 8G, the guide 800 can be pushed or pulled (e.g., by pushing or pulling the deployment manipulator) to cause the distal sleeve to close and capture the distal end of the prosthetic valve, thereby fixing the load and securing the prosthetic heart valve in the deployment assembly 850 in a collapsed position.

[0071] 8H-8I, the deployment assembly 850 is shown with the distal sleeve 826 moving proximally. FIG. 8H corresponds to FIG. 8F and shows the distal sleeve 826 advancing over the taper assembly 827 as the protrusion 802 of FIG. 8F traverses the bypass channel 835 and the angled channel 840, bypassing the bypass spring 830 of FIG. 8F. FIG. 8I shows the protrusion 802 of FIG. 8F traverses the delivery channel 801 toward the locking channel 842, and the distal sleeve 826 continues to move proximally relative to the taper assembly 827. Once the prosthetic valve is secured to the proximal end of the deployment assembly 850, the distal end of the prosthetic valve contracts and is surrounded by the distal sleeve 826 as it moves proximally, allowing the prosthetic valve to be fully secured to the deployment assembly 850 in a collapsed state. To maintain the prosthetic valve in the delivery channel 801 in a collapsed state, the guide 800 can be rotated to place the protrusion 802 into the locking channel 842 .

[0072] The foregoing description of exemplary embodiments has been presented for purposes of illustration and description. It is to be understood that the embodiments described herein are exemplary, and that the components may be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are contemplated and within the scope of the present disclosure. It is not intended to be exhaustive or to be limiting to the precise forms disclosed, but modifications and variations are possible in light of the above teachings or may be obtained from practice of the disclosed embodiments. It is intended that the scope of the invention be defined by the appended claims and their equivalents.

Claims

1. 1. A delivery catheter for implanting a prosthetic heart valve, comprising: a deployment assembly disposed at a distal end of the delivery catheter, the deployment assembly being sized and shaped to be advanced to an implantation site of a native heart valve and comprising a sleeve configured to retain at least a portion of the prosthetic heart valve in a collapsed delivery state; a handle portion disposed at a proximal end of the delivery catheter, the handle portion including a protrusion; a guide in mechanical communication with the handle portion, configured to rotate relative to the handle portion, the guide including a first channel configured to receive the protrusion, the guide configured to translate movement of the protrusion along the first channel to the sleeve such that distal movement of the sleeve releases the prosthetic heart valve; A delivery catheter comprising:

2. 2. The delivery catheter of claim 1, wherein the first channel comprises a spring that allows movement of the protrusion in a first direction along the first channel and resists movement of the protrusion in a second direction opposite the first direction, the spring configured to provide tactile feedback when the sleeve releases the prosthetic heart valve.

3. 3. The delivery catheter of claim 2, wherein the guide further comprises a bypass channel connected to the first channel and configured to allow the protrusion to bypass the spring, thereby allowing the protrusion to move in the second direction opposite the first direction.

4. The delivery catheter of claim 3 , wherein the bypass channel comprises a ramp configured to guide the protrusion from the bypass channel into the first channel.

5. The delivery catheter of claim 2 , wherein the spring is a cantilevered portion of the first channel having a spring force.

6. The delivery catheter of claim 5 , wherein the cantilevered portion is resilient.

7. 2. The delivery catheter of claim 1, wherein the guide further comprises a second channel connected to a first end of the first channel, the second channel configured to lock the protrusion when the prosthetic heart valve is loaded into the deployment assembly.

8. The delivery catheter of claim 7 , wherein the second channel is perpendicular to the first channel.

9. The delivery catheter of claim 7 , wherein the guide further comprises a third channel connected to a second end of the first channel, the third channel being perpendicular to the first channel.

10. The delivery catheter of claim 9 , further comprising a fourth channel perpendicular to and connected to the third channel.

11. The delivery catheter of claim 10 , wherein the fourth channel is configured to lock the protrusion when the deployment assembly is removed.

12. 1. A method of deploying a prosthetic heart valve using a delivery catheter, comprising: advancing a deployment assembly disposed at a distal end of the delivery catheter to an implantation site of a native heart valve, the deployment assembly including a sleeve adapted to retain at least a portion of the prosthetic valve in a collapsed delivery state; advancing a guide comprising a first channel in mechanical communication with the sleeve and engaging a handle portion disposed at a proximal end of the delivery catheter, the handle portion comprising a protrusion, the protrusion traversing the first channel, thereby moving the sleeve distally to release the at least a portion of the prosthetic heart valve; A method comprising:

13. advancing a sheath containing a sheath marker band into the patient's heart at the sinoaortic junction; inserting the delivery catheter having a sealing ring marker band into the sheath; advancing the delivery catheter through the sheath until the sealing ring marker band is aligned with the sheath marker band; aligning the distal end of the delivery catheter with the native heart valve within the patient's heart; The method of claim 12 further comprising:

14. 14. The method of claim 13, wherein aligning the distal end of the delivery catheter with the native heart valve in the patient's heart comprises rotating a manipulator engaged with the handle portion.

15. The method of claim 12, further comprising removing a safety clip removably connected to the handle portion before advancing the guide.

16. 13. The method of claim 12, further comprising, before advancing the guide, rotating the guide engaged with the handle portion, thereby causing the protrusion to cross a second channel that is perpendicular to the first channel and connected to the first channel, the second channel adapted to lock the protrusion when the prosthetic heart valve is loaded into the deployment assembly.

17. 13. The method of claim 12, wherein the first channel comprises a spring that resists movement of the protrusion in a second direction opposite the first direction, the spring being positioned within the first channel to cause tactile feedback when the sleeve releases the at least a portion of the prosthetic heart valve.

18. 18. The method of claim 17, further comprising retracting the guide to move the protrusion along the first channel in the second direction to a bypass channel connected to the second channel, thereby bypassing the spring.

19. 20. The method of claim 18, wherein the protrusion bypasses the spring by moving along a ramp in the bypass channel.

20. 20. The method of claim 18, further comprising rotating the guide to cause the protrusion to traverse the second channel in the second direction.

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