Catheters and methods for delivering implants

Abstract

In one embodiment, a catheter for delivering an implant is provided. The catheter includes an inner shaft, an outer shaft surrounding the inner shaft, a door coupled to the inner shaft at a hinge, a biasing element biasing the door in a closed position to hold an anchor of the implant between the door and the inner shaft, and an actuation device coupled to the door and disposed between the inner shaft and the outer shaft, the actuation device configured to open the door when pulled to release the anchor from the catheter.

Description

CATHETERS AND METHODS FOR DELIVERING IMPLANTSTECHNICAL FIELD

[0001] The present disclosure relates to catheters and methods for delivery of implants to hollow bodies (e.g., blood vessels), and more particularly catheters and methods providing an implant delivery mechanism.BACKGROUND

[0002] An implant (e.g., a vascular implant) is held by a catheter to be delivered to a desired location. Once aligned at the desired location, the implant is separated from the catheter and remains at the desired location for various purposes including medical treatments. Delivering an implant to a desired location may prove difficult. In particular, various delivery and / or alignment failures may occur which prevents accurate placement of the implant within a vessel. For example, premature separation of the implant from the catheter or incomplete separation of the implant from a delivery mechanism may happen, each of which may require removal of the implant and redelivery or replacement, leading to increased costs and procedure times.SUMMARY

[0003] To reduce chances of a delivery (e.g., separation failure, alignment failure, or the like), catheters with a delivery mechanism and methods that provide improved delivery and separation of an implant are provided herein..

[0004] In one embodiment, a catheter for delivering an implant is provided. The catheter includes an inner shaft, an outer shaft surrounding the inner shaft, a door coupled to the inner shaft at a hinge, a biasing element biasing the door in a closed position to hold an anchor of the implant between the door and the inner shaft, and an actuation device coupled to the door, the actuation device configured to open the door when pulled to release the anchor from the catheter.

[0005] In another embodiment, a catheter for delivering an implant is provided. The catheter includes a shaft, a pull body disposed in the shaft and proximally moveable with respect to the shaft, the pull body including a pull body inclined surface inclined proximally, and a stator disposed distal to the pull body in the shaft, the stator including a stator inclined surface inclined proximally, wherein an anchor of the implant is held between the pull body and the stator, and theanchor is released when the pull body is moved proximally away from the stator such that the pull body inclined surface and the stator inclined surface are aligned.

[0006] These and additional features provided by the embodiments described herein will be more fully understood in view of the following detailed description, in conjunction with the drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The embodiments set forth in the drawings are illustrative and exemplary in nature and not intended to limit the subject matter defined by the claims. The following detailed description of the illustrative embodiments can be understood when read in conjunction with the following drawings, where like structure is indicated with like reference numerals and in which:

[0008] FIG. 1 A schematically depicts a cross sectional view of a catheter holding an anchor of an implant, according to one or more embodiments shown and described herein;

[0009] FIG. IB schematically depicts a cross sectional view of the catheter of FIG. 1A where an outer shaft of the catheter is retracted, thereby exposing the implant, according to one or more embodiments shown and described herein;

[0010] FIG. 1C schematically depicts a cross sectional view of the catheter of FIG. IB where a hinged door of the catheter is opened, according to one or more embodiments shown and described herein;

[0011] FIG. ID schematically depicts a cross sectional view of the catheter of FIG. 1A where the implant is separated from the catheter, according to one or more embodiments shown and described herein;

[0012] FIG. 2A schematically depicts a cross sectional view of a catheter holding an anchor of an implant, according to one or more embodiments shown and described herein;

[0013] FIG. 2B schematically depicts a cross sectional view of the catheter of FIG. 2A where an outer shaft of the catheter is retracted, thereby exposing the implant, according to one or more embodiments shown and described herein;

[0014] FIG. 2C schematically depicts a cross sectional view of the catheter of FIG. 2A where a pull body is proximally moved, according to one or more embodiments shown and described herein;

[0015] FIG. 2D schematically depicts a cross sectional view of the catheter of FIG. 2A where the implant is separated from the catheter, according to one or more embodiments shown and described herein;

[0016] FIG. 3A schematically depicts a perspective view of a pull body and a stator that may be used with the catheter of FIG. 2A, according to one or more embodiments shown and described herein;

[0017] FIG. 3B schematically depicts a cross sectional view of the pull body and the stator of FIG. 3A, according to one or more embodiments shown and described herein;

[0018] FIG. 3C schematically depicts a cross sectional view of the pull body and the stator of FIG. 3A where the pull body is moved proximally with respect to the stator, according to one or more embodiments shown and described herein; and

[0019] FIG. 3D schematically depicts a cross sectional view of another embodiment of a pull body and a stator where the pull body is moved proximally with respect to the stator, according to one or more embodiments shown and described herein.

[0020] Reference will now be made in greater detail to various embodiments of the present disclosure, some embodiments of which are illustrated in the accompanying drawings. Whenever possible, the same reference numerals will be used throughout the drawings to refer to the same or similar parts.DETAILED DESCRIPTION

[0021] Embodiments described herein are directed to catheters and methods for delivery of implants to hollow bodies. In some embodiments, the catheters and methods may be used to deliver the implants to blood vessels. More particularly, a catheter may be placed in a blood vessel to deliver an implant. For example, the catheter may include an implant delivery mechanism that holds the implant while the catheter is advanced through the blood vessel to a delivery location. The implant delivery mechanism may release the implant at the delivery location. The implantdelivery mechanism as stated below in embodiments of the present disclosure may lead to reduction of costs while reducing likelihood of implant delivery failure or misalignment. These and additional features and benefits will be described in greater detail herein.

[0022] Referring to FIG. 1A, a catheter 10 for delivering an implant 300 is depicted. The catheter 10 includes an inner shaft 200 and an outer shaft 100 surrounding the inner shaft 200. The inner shaft 200 may be disposed in a lumen 112 defined by the outer shaft 100. The catheter 10 may be sized to be advanced through a blood vessel. The catheter 10 may have any cross-sectional shape and any diameter suitable for intravascular use. For example, the outer shaft 100 may have an outer shaft body 110 that may have a tubular shape (e.g., a cylindrical shape, a circular tubular shape, or the like) that may define the lumen 112. The inner shaft 200 may include an inner shaft body 210 that may have a tubular shape (e.g., a cylindrical shape, a circular tubular shape, or the like) that may define a lumen 212. The lumen 112 and the lumen 212 may extend at least partially along or through the outer shaft body 110 and the inner shaft body 210, respectively. For instance, the lumens 112 and 212 may extend at least partially longitudinally through the catheter 10 in the direction of an x-axis of the depicted coordinate axes of FIG. 1 A.

[0023] In embodiments, the outer shaft body 110 and the inner shaft body 210 may be configured to be moved with respect to each other. For example, the outer shaft body 110 may be moved proximally or distally with respect to the inner shaft body 210. The outer shaft body 110 may also be rotatable with respect to the inner shaft body 210. The outer shaft body 110 and the inner shaft body 210 may be formed of any material or combination of materials able to be traversed through a vasculature of a body. For example, the outer shaft body 110 and the inner shaft body 210 may include, silicone, rubber, metal (e.g., stainless still, litinol, or the like), plastic, etc.

[0024] In embodiments, the inner shaft 200 further includes a door 220 that is coupled to the inner shaft at a hinge 250 (e.g., a hinged connection). The hinge 250 may be disposed at a first end 222 of the door and may rotationally support the door 220 at the hinge 250. A biasing element 230 is disposed at the hinge 250, and the biasing element 230 may include a first portion 231 coupled to the door 220 (e.g., the first end 222) and a second portion 232 coupled to the inner shaft body 210. The biasing element 230 biases the door 220 in a closed position as shown in FIG. 1A to hold an anchor 330 of the implant 300 between the door 220 and the inner shaft 200. In embodiments, a tether 320 that couples the anchor to an implant body 310 may be held at a secondend 224 of the door 220. In embodiments, the biasing element 230 may be a spring (e.g., a torsion spring, helical spring, leaf spring, or the like) which may exerts biasing force to hold the tether 320 securely. The anchor may be disposed in the lumen 212 and the implant body 310 may be disposed in the lumen 112 while the catheter 10 is advanced through the blood vessel.

[0025] The implant 300 may include, as non-limiting examples, mesh, filters, coils, cardiac stents, implantable electrical systems, or the like. The implant 300 may be configured to be delivered intravascularly. In embodiments, the implant 300 has the anchor 330 that is coupled to an implant body 310 via a tether 320. In embodiments, the implant body 310 may provide stability in the blood vessel, while the anchor 330 may provide stability in the catheter 10. The anchor 330 may be any structure capable of being captured between the door 220 and the inner shaft 200. For example, the anchor may be a structure of increased width, thickness, or diameter as compared with the tether 320, so as to provide a structure to be held. For example, the anchor 330 may be substantially spherical or shaped such that the anchor 330 may be captured between the door 220 and the inner shaft body 210. The anchor 330 may be attached to the tether 320, which may be a wire, string, etc., that couples the anchor 330 to the implant body 310. The tether 320 may have some degree of flexibility in order to be fit or bend between the door 220 and the inner shaft body 210. As depicted the tether 320 couples the anchor 330 to the implant body 310. In various embodiments, the tether 320, the anchor 330, and the implant body 310, may be formed of the same materials or different materials, which may be integrally formed with one another, or different materials. In embodiments, the tether 320, the anchor 330, and / or the implant body 310 may be coupled to one another such as via tying, adhesive bonds, welding, brazing, etc.

[0026] In embodiments, tether, the anchor, and the implant may be formed of biocompatible materials. In embodiments, the material(s) may meet 10993-1 biocompatibility testing requirements for long term (greater than 30 days) blood exposure. Example materials include but are not limited to stainless steel, Nitinol, ePTFE, polyethylene, polystyrene, PEEK, silicone, glass, magnesium, titanium, etc.

[0027] The door 220 may be coupled to an actuation device 240 such as a wire, thread, filament, rod, or the like. The actuation device 240 may be disposed between the inner shaft 200 and the outer shaft 100. In FIG. 1, the actuation device 240 is illustrated in a neutral state (e.g., not being pulled or pushed) and the biasing element 230 biases the door 220 to the closed state. The actuationdevice 240 is configured to open the door 220 when being pulled to release the anchor 330 from the catheter 10, which will be discussed in more detail with respect to FIGS. 1C and ID.

[0028] Referring now to FIG. IB, the outer shaft 100 is configured to move or slide proximally with respect to the inner shaft 200 to expose the implant 300 from the catheter 10. In embodiments, the catheter 10 may be advanced through a vessel 50 (e.g., a blood vessel or the like). In embodiments, the outer shaft 100 may be rotated with respect to the inner shaft 200 to change the position of the anchor 330. For example, directional changes to the anchor 330 may be made by rotating the inner shaft 200 with respect to the outer shaft 100. The tether 320 may be held or caught between the inner shaft body 210 and the door 220, and rotation of the inner shaft 200 may move the location of the tether 320. As a result, the location of the tether 320 (e.g., the second end 224 of the door 220) may be changed from one side (e.g., a side facing 0 Y direction of the coordinate axes of FIG. IB) to the other side (e.g., a side facing +Y direction of the coordinate axes of FIG. IB) or any other directions along the circumference of the catheter 10. Such may result in rotating the implant body 310 as desired.

[0029] Once the catheter 10 is positioned at a delivery location in the vessel 50 as shown in FIG. IB, the implant 300 (e.g., the implant body 310) may be exposed from the catheter 10, such as by advancing the inner shaft 200 beyond a distal end of the outer shaft 100 or by retracting the outer shaft 100 proximally from the implant and / or the distal end of the inner shaft 200. When the implant body 310 is exposed outside of the outer shaft 100, the anchor 330 remains held between the door 220 and the inner shaft 200 by biasing the door 220 in the closed position by the biasing element 230. In embodiments, when the implant body 310 is exposed, the tether 320, the door 220, and a distal end portion 214 of the inner shaft 200 may also be exposed to improve implant delivery accuracy, for example.

[0030] Referring to FIG. 1C, the door 220 is in an open position to release the anchor 330 from the catheter 10 to deliver the implant 300 at the delivery location. To open the door 220, the actuation device 240 is may be pulled proximally to rotate the door 220 at the hinge 250. Pulling the actuation device 240 overcome the force of the biasing element 230, such as by compressing, stretching, straightening, or bending the biasing element 230. In embodiments, the anchor 330 may be shaped and sized to pass through a space between the door 220 and the inner shaft body 210 when the door 220 is in the open position. In some embodiments, it is contemplated the actuation device 240 may be located inside the inner shaft 200 and may pull the door 220 inward.

[0031] Referring to FIG. ID, the catheter 10 may be moved back away (e.g., in a proximal direction, such as the 0 X directed of the depicted coordinate axes) from the implant body 310 to release or disengage the anchor 330 from the catheter 10. When the catheter 10 is moved away from the implant body 310, the door 220 may remain open so that to ensure that the anchor 330 is fully disengaged from the catheter 10, which may improve delivery accuracy and reduce delivery failure. Such clearance may be confirmed such as via ultrasound, x-ray, fluoroscopy, or the like. It is noted that the catheter 10 may be advanced through the blood vessel distally (e.g., + X direction of the coordinate axes of FIG. ID) to deliver the implant 300 to the delivery location, and the catheter 10 is moved proximally (e.g., - X direction of the coordinate axes of FIG. ID) to release the implant 300. Since the actuation device 240 is also pulled proximally to open the door 220 to release the implant 300, it is less likely the catheter 10 is accidentally moved distally and move the position of the implant 300 away from the delivery location. Therefore, the proximal movement of the catheter 10 including the actuation device 240 may improve delivery accuracy and reduce delivery failure.

[0032] Though only a single door 220 is discussed above, it is contemplated that there may be two or more doors which fold toward one another to secure the anchor 330 between the two or more doors and fold away from one another to release the anchor 330. In such embodiments, the doors may be independently actuated. For example, each door may be coupled to its own actuation device 240 to allow for independent actuation. In other embodiments, each door may be operated via a single actuation device for simultaneous activation

[0033] Referring to FIG. 2A, a catheter 20 for delivering the implant 300 is depicted. The catheter 20 includes a shaft (e.g., an inner shaft 400). In embodiments, the shaft may include an outer shaft 100 and the inner shaft 400. The outer shaft 100 and the implant 300 as shown in FIG. 2A-2D are similar to those depicted in FIGS. 1A-1D with the same reference numbers, and the detailed descriptions thereof are omitted. An implant delivery mechanism 500 may include a pull body 520 disposed in the shaft (e.g., in a lumen 412 defined by an inner shaft body 410 of the inner shaft 400), and the pull body 520 is longitudinally (e.g., proximally and / or distally) moveable with respect to the shaft. For example, the pull body 520 may slide along the inner shaft body 410. The pull body 520 includes a pull body inclined surface 522 inclined proximally (e.g., in a proximal direction as shown in 0 X direction of the coordinate axes of FIG. 2A). In embodiments, the pull body 520 has generally a tubular shape (e.g., a cylindrical shape with a hollow space defined by the pull body inclined surface 522 and a surface 524 of the pull body 520facing the stator inclined surface 532. The pull body 520 may be formed of any suitable material including metals, polymers, or the like.

[0034] The implant delivery mechanism 500 may further include a stator 530 disposed in the shaft (e.g., in the lumen 412). The stator 530 includes a stator inclined surface 532 inclined proximally (e.g., in the proximal direction as shown in 0 X direction of the coordinate axes of FIG. 2A). For example, the stator 530 may have a generally tubular shape with at least a position of the inner surface being inclined. In embodiments, the pull body 520 may be coupled to an actuation device 440 such as a wire, thread, filament, rod, or the like. The pull body 520 may be moved proximally with respect to the stator 530 when the actuation device 440 is being pulled. The pull body 520 may be coupled to a biasing element 430 which may bias the pull body 520 distally (e.g., in a distal direction as shown in +X direction of the coordinate axes of FIG. 2A). In embodiments, the biasing element 430 may be a helical spring, a coil spring, or the like and configured to be compressed when the pull body 520 is moved proximally. In embodiments, the stator 530 may be coupled to the inner shaft 400 such that the stator 530 may remain at the same position when the pull body 520 is moved. In embodiments, the stator 530 may be formed as a part of the inner shaft 400, for example, as a protrusion protruding out from the inner shaft body 410. The stator 530 may be moved together with the inner shaft 400 while maintaining the position with respect to the inner shaft 400. The stator 530 may be formed of any suitable material including metals, polymers, or the like.

[0035] The anchor 330 of the implant 300 is held between the pull body 520 and the stator 530. In embodiments, the anchor 330 may be held between the pull body inclined surface 522 and a surface 534 (e.g., a holding surface) of the stator 530 facing the pull body inclined surface 522. The surface 534 may be disposed radially opposite to the stator inclined surface 532, and the anchor 330 is held between the surface 534 and the pull body inclined surface 522. In embodiments, the pull body inclined surface 522 and the stator inclined surface 532 may radially overlap with each other when the anchor 330 is held between the pull body 520 and the stator 530. For example, the pull body inclined surface 522 and the stator inclined surface 532 are overlapped with each other when viewed from a radial direction (e.g., + / -Y direction of the coordinate axes of FIG. 2A).

[0036] Referring to FIG. 2B, in embodiments, the outer shaft 100 may be configured to move with respect to the inner shaft 400. In embodiments, the catheter 20 may be advanced through avessel 70 (e.g., a blood vessel or the like). For example, the outer shaft body 110 may be moved proximally or distally, or rotated with respect the inner shaft body 410. The outer shaft 100 may be moved proximally with respect to the inner shaft 400 to expose the implant 300. In embodiments, the outer shaft 100 may be rotated with respect to the inner shaft 400 to change the position of the anchor 330. For example, directional changes to the anchor 330 may be made by rotating the inner shaft 400 with respect to the outer shaft 100. As a result, a location of the tether 320 (e.g., a location of a space between the stator inclined surface 532 and the surface 524 of the pull body 520 facing the stator inclined surface 532) may be changed from one side (e.g., a side facing +Y direction of the coordinate axes of FIG. 2B) to the other side (e.g., a side facing -Y direction of the coordinate axes of FIG. 2B) or any other directions along the circumference of the catheter 20. Also, a location of the anchor 330 (e.g., a location of a space between the pull body inclined surface 522 and the surface 534 of the stator 530 facing the pull body inclined surface 522) may be changed from one side (e.g., a side facing -Y direction of the coordinate axes of FIG. 2B) to the other side (e.g., a side facing +Y direction of the coordinate axes of FIG. 2B) or any other directions along the circumference of the catheter 20. Changes in the location of the tether 320 and / or the anchor 330 may affect the position of the implant body 310 to allow a user to adjust the rotational alignment of the implant body 310 as desired.

[0037] Once the catheter 20 is positioned at a delivery location in the vessel 70 as shown in FIG. 2B, the implant 300 (e.g., the implant body 310) may be exposed from the catheter 20, such as by advancing the inner shaft 400 beyond a distal end of the outer shaft 100 or by retracting the outer shaft 100 proximally from the implant and / or the distal end of the inner shaft 400. When the implant body 310 is exposed outside of the outer shaft 100, the anchor 330 remains held between the pull body 520 and the stator 530 by biasing the pull body 520 distally by the biasing element 430. In embodiments, when the implant body 310 is exposed, the tether 320 and a distal end portion 414 of the inner shaft body 410 may also be exposed to improve implant delivery accuracy, for example. In embodiments, the anchor 330 may be held between the pull body inclined surface 522 and the surface 534 of the stator 530 facing the pull body inclined surface 522.

[0038] Referring to FIG. 2C, the pull body 520 is proximally moved with respect to the stator 530. The anchor 330 may be configured to be released when the pull body 520 is moved proximally away from the stator 530 such that the pull body inclined surface 522 and the stator inclined surface 532 are aligned. The actuation device 440 may be pulled proximally to move the pull body 520 away from the stator 530. Pulling the actuation device 440 may compress the biasingelement 430 in the proximal direction (e.g., -X direction of the depicted coordinate axes). In embodiments, the pull body inclined surface 522 and the stator inclined surface 532 may be aligned along a common plane (e.g., a plane 90) when the pull body 520 is moved proximally away from the stator to release the anchor 330. In embodiments, the pull body inclined surface 522 and the stator inclined surface 532 may be oriented at the same angle with respect to a longitudinal direction (e.g., + / -X direction of the coordinate axes of FIG. 2C). The anchor 330 may slide along the common plane when the implant delivery mechanism 500 is in the releasing position and the implant delivery mechanism 500 (e.g., the catheter 20) is moved proximally to release the implant 300.

[0039] In embodiments, the pull body inclined surface 522 and the stator inclined surface 532 may be oriented at a different angle with respect to the longitudinal direction (e.g., + / -X direction of the coordinate axes of FIG. 2C). For example, an acute angle of the stator inclined surface 532 may be smaller than an acute angle of the pull body inclined surface 522 with respect to the longitudinal direction, though in other embodiments the acute angle of the stator inclined surface 532 may be larger than the acute angle of the pull body inclined surface 522. When aligned, the pull body inclined surface 522 and the stator inclined surface 532 may be continuously arranged. For example, there may be no gap between the pull body inclined surface 522 and the stator inclined surface 532. The continuously arranged pull body inclined surface 522 and the stator inclined surface 532 may provide smooth release of the anchor 330 without trapping the anchor 330 between the pull body 520 and the stator 530.

[0040] In embodiments, the biasing element 430 may be coupled to the inner shaft body 410. For example, a proximal end portion 432 of the biasing element 430 may be fixed to the inner shaft body 410. The proximal end portion 432 may restrict movement of the biasing element 430, and the biasing element 430 may be compressed when the pull body 520 is being pulled by the actuation device 440. In embodiments, the proximal end portion 432 may serve as a backstop restricting the movement of the pull body 520 in the proximal direction. The movement of the pull body 520 may be restricted at an alignment position where the pull body inclined surface 522 and the stator inclined surface 532 are aligned. For example, the proximal end portion 432 may restrict the proximal movement of the pull body 520 such that the pull body 520 stops at the alignment position.

[0041] In embodiments, the biasing element 430 may be disposed between a stop (e.g., a stop 41) and the pull body 520. The stop may be a protrusion (e.g., a projection, a bump, a block, or the like) which may protrude from an inner surface 417 of the inner shaft body 410. For example, the stop may restrict movement of the biasing element 430, and the biasing element 430 may be compressed when the pull body 520 is being pulled by the actuation device 440. In embodiments, the stop may stop the movement of the pull body 520 in the proximal direction. The movement of the pull body 520 may be restricted at the alignment position where the pull body inclined surface 522 and the stator inclined surface 532 are aligned. For example, the stop may restrict the proximal movement of the pull body 520 such that the pull body 520 stops at the alignment position.

[0042] Referring to FIG. 2D, the catheter 20 may be moved back away from the implant body 310 to release or disengage the anchor 330 form the catheter 20. When the catheter 20 is moved away from the implant body 310, the pull body 520 may remain being pulled away from the stator 530 so that to ensure that the anchor 330 is fully disengaged from the catheter 20, which may improve delivery accuracy and reduce delivery failure. In embodiments, the anchor 330 may slide along the pull body inclined surface 522 and the stator inclined surface 532 (e.g., along the plane 90) to be released from the catheter 20. It is noted that the catheter 20 is advanced through the blood vessel distally (e.g., + X direction of the coordinate axes of FIG. 2D) to deliver the implant 300 to the delivery location, and the catheter 20 is moved proximally (e.g., - X direction of the coordinate axes of FIG. 2D) to release the implant 300. Since the actuation device 440 is also pulled proximally to pull the pull body 520 away from the stator 530 to release the implant 300, it is less likely the catheter 20 is accidentally moved distally and move the position of the implant 300 away from the delivery location. Therefore, the proximal movement of the catheter 20 including the actuation device 440 may improve delivery accuracy and reduce delivery failure.

[0043] Referring to FIGS. 3A-3C, another embodiment of an implant delivery mechanism 600 is depicted. The implant delivery mechanism 600 may include a pull body 620 and a stator 630. The pull body 620 and the stator 630 are similar to the pull body 520 and the stator 530 shown in FIGS. 2A-2D. The stator 630 further includes a distal portion 633. The pull body 620 includes a pull body inclined surface 622 inclined proximally (e.g., a proximal direction as shown in 0 X direction of the coordinate axes of FIG. 3A). The stator 630 includes a stator inclined surface 632 inclined proximally (e.g., the proximal direction as shown in 0 X direction of the coordinate axes of FIG. 3A).

[0044] In embodiments, the implant delivery mechanism 600 may replace the implant delivery mechanism 500 shown in FIGS. 2A-2D. For example, when the implant delivery mechanism 600 is disposed in the inner shaft 400, the pull body 620 and the stator 630 may be disposed in the inner shaft 400 in the lumen 412 defined by the inner shaft body 410. The stator 630 may be coupled to the inner shaft 400 via any suitable coupling technique (e.g., press fit, adhesive bonding, welding, fasteners, etc.). The pull body 620 may be longitudinally (e.g., proximally and / or distally) moveable with respect to the inner shaft 400. For example, the pull body 620 may slide along the inner shaft body 410. The pull body 620 may be coupled to the actuation device 440 such that the pull body 620 may be moved proximally with respect to the stator 630 when the actuation device 440 is being pulled. For example, the actuation device 440 may be coupled to a proximal surface 621 of the pull body 620. The pull body 620 may be coupled to the biasing element 430 which may bias the pull body 620 distally (e.g., in a distal direction as shown in +X direction of the coordinate axes of FIG. 3 A). As noted above, the stator 630 may be coupled to the inner shaft 400 such that the stator 630 may remain at the same position when the pull body 620 is moved. For example, the distal portion 633 may be coupled to the inner shaft 400, such that the relative position of the stator 630 with respect to the inner shaft 400 is fixed. The stator 630 may be moved together with the inner shaft 400 while maintaining the position with respect to the inner shaft 400.

[0045] Referring to FIG. 3B, the pull body 620 and the stator 630 are in a holding position where the anchor 330 of the implant 300 may be held between the pull body 620 and the stator 630. For example, the anchor 330 may be held between the pull body inclined surface 622 and a surface 634 (e.g., a holding surface) of the stator 630 facing the pull body inclined surface 622. The surface 634 may be disposed radially opposite to the stator inclined surface 632, and the anchor 330 may be held between the surface 634 and the pull body inclined surface 622. When in the holding position, a distal surface 626 of the pull body 620 may contact a proximal surface 631 of the stator 630. A space 62 defined between the stator inclined surface 632 and a surface 624 of the pull body 620 facing the stator inclined surface 632 and a space 63 defined between a surface 636 and a surface 635 of the stator 630 may communicate in the holding position. The tether 320 of the implant 300 may be passed through the space 62 and the space 63.

[0046] Referring to FIG. 3C, the pull body 620 is proximally moved away from the stator 630 in a releasing position where the anchor 330 of the implant 300 may be released from the implant delivery mechanism 600. In the releasing position, the pull body inclined surface 622 and the stator inclined surface 632 are aligned. For example, the pull body inclined surface 622 and thestator inclined surface 632 may be aligned along a common plane (e.g., a plane 80) when the pull body 620 is moved proximally away from the stator 630. In embodiments, the pull body inclined surface 622 and the stator inclined surface 632 may be oriented at the same angle with respect to a longitudinal direction (e.g., + / -X direction of the coordinate axes of FIG. 3C). The anchor 330 may slide along the common plane when the implant delivery mechanism 600 is in the releasing position and the implant delivery mechanism 600 (e.g., the catheter including the implant delivery mechanism 600) is moved proximally to release the implant 300. The anchor 330 may pass through the space 62 and space 63 while being released from the implant delivery mechanism 600.

[0047] In embodiments, the pull body inclined surface 622 and the stator inclined surface 632 may be oriented at the same angle with respect to the longitudinal direction (e.g., + / -X direction of the coordinate axes of FIG. 3C). For example, an acute angle A may be the same as an acute angle B with respect to the longitudinal direction. When aligned, the pull body inclined surface 622 and the stator inclined surface 632 may be continuously arranged. For example, there may be no gap between the pull body inclined surface 622 and the stator inclined surface 632. The continuously arranged pull body inclined surface 622 and the stator inclined surface 632 may provide smooth release of the anchor 330 without trapping the anchor 330 between the pull body 620 and the stator 630.

[0048] FIG. 3D depicts another embodiment of a pull body 6200 and a stator 6300. The pull body 6200 is proximally moved away from the stator 6300 in a releasing position where the anchor 330 of the implant 300 may be released from the implant delivery mechanism 6000. In the releasing position, the pull body inclined surface 6220 and the stator inclined surface 6320 are aligned. For example, the pull body inclined surface 6220 and the stator inclined surface 6320 may be aligned when the pull body 6200 is moved proximally away from the stator 6300. In embodiments, the anchor 330 may slide along the pull body inclined surface 6220 and the stator inclined surface 6320 when the implant delivery mechanism 6000 is in the releasing position and the implant delivery mechanism 6000 (e.g., the catheter including the implant delivery mechanism 6000) is moved proximally to release the implant 300. The anchor 330 may pass through the space 620 and space 630 while being released from the implant delivery mechanism 6000.

[0049] In embodiments, the pull body inclined surface 6220 and the stator inclined surface 6320 may be oriented at a different angle with respect to the longitudinal direction (e.g., + / -X direction of the coordinate axes of FIG. 3D). For example, an acute angle C may be larger than an acuteangle D with respect to the longitudinal direction. When aligned, the pull body inclined surface 6220 and the stator inclined surface 6320 may be continuously arranged. For example, there may be no gap between the pull body inclined surface 6220 and the stator inclined surface 6320. The continuously arranged pull body inclined surface 6220 and the stator inclined surface 6320 may provide smooth release of the anchor 330 without trapping the anchor 330 between the pull body 6200 and the stator 6300.

[0050] In embodiments, the catheter 20 having the implant delivery mechanism 500, the implant delivery mechanism 600, or the implant delivery mechanism 6000 may be utilized in steps including holding the anchor 330 between the pull body 520, 620, or 6200 and the stator 530, 630 or 6300, positioning the catheter 20 at a delivery location (e.g., FIG. 2A), and releasing the anchor 330 from the catheter 20 by moving the pull body 520, 620, or 6200 proximally away from the stator 530, 630, or 6300 such that the pull body inclined surface 522, 622, or 6220 and the stator inclined surface 532, 632, or 6320 are aligned, (e.g., FIG. 2B). The steps may further include moving the outer shaft 100 proximally with respect to the inner shaft 400 to expose the implant 300 from the catheter 20 (e.g., FIG. 2C). Additionally, the steps may include moving the catheter 20 proximally with respect to the delivery location to release the anchor 330 from the catheter 20. (e.g., FIG. 2D)

[0051] Embodiments can be described with reference to the following numerical clause:

[0052] 1. A catheter for delivering an implant, the catheter comprising: an inner shaft; an outer shaft surrounding the inner shaft; a door coupled to the inner shaft at a hinge; a biasing element biasing the door in a closed position to hold an anchor of the implant between the door and the inner shaft; and an actuation device coupled to the door, the actuation device configured to open the door when pulled to release the anchor from the catheter.

[0053] 2. The catheter of any preceding clause, wherein: the biasing element is a torsion spring, and / or the biasing element is a torsion spring; and / or the actuation device is disposed between the inner shaft and the outer shaft.

[0054] 3. The catheter of any preceding clause, wherein the outer shaft is configured to move proximally with respect to the inner shaft to expose the implant from the catheter.

[0055] 4. A method for delivering an implant by the catheter of any preceding clause, the method comprising: holding the anchor between the door and the inner shaft by biasing the doorin the closed position by the biasing element; positioning the catheter at a delivery location; and releasing the anchor from the catheter by pulling the actuation device to open the door.

[0056] 5. The method of any preceding clause, further comprising: moving the outer shaft proximally with respect to the inner shaft to expose the implant from the catheter.

[0057] 6. The method of any preceding clause, further comprising: moving the catheter proximally with respect to the delivery location to release the anchor from the catheter.

[0058] 7. A catheter for delivering an implant, the catheter comprising: a shaft; a pull body disposed in the shaft and proximally moveable with respect to the shaft, the pull body including a pull body inclined surface inclined proximally; and a stator disposed in the shaft, the stator including a stator inclined surface inclined proximally, wherein an anchor of the implant is held between the pull body and the stator, and the anchor is released when the pull body is moved proximally away from the stator such that the pull body inclined surface and the stator inclined surface are aligned.

[0059] 8. The catheter of clause 7, wherein the pull body inclined surface and the stator inclined surface are aligned along a common plane when the pull body is moved proximally away from the stator to release to anchor.

[0060] 9. The catheter of any of clauses 7-8, wherein the pull body is coupled to an actuation device configured to move the pull body proximally with respect to the stator.

[0061] 10. The catheter of any of clauses 7-9, further comprising: a stop stopping the movement of the pull body at an alignment position where the pull body inclined surface and the stator inclined surface are aligned.

[0062] 11. The catheter of any of clauses 7-10, further comprising a biasing element configured to bias the pull body distally.

[0063] 12. The catheter of any of clauses 7-11, wherein the pull body inclined surface and the stator inclined surface radially overlap with each other when the anchor is held between the pull body and the stator.

[0064] 13. The catheter of any of clauses 7-12, wherein the stator includes a holding surface disposed radially opposite to the stator inclined surface, and the anchor is held between the holding surface and the pull body inclined surface.

[0065] 14. The catheter of any of clauses 7-13, wherein the shaft includes an inner shaft and an outer shaft surrounding the inner shaft, the outer shaft is configured to move proximally with respect to the inner shaft such that to expose the implant from the catheter.

[0066] 15. The catheter of any of clauses 7-14, wherein the stator is coupled to the inner shaft.

[0067] 16. The catheter of any of clauses 7-15, wherein the pull body inclined surface and the stator inclined surface are inclined in the same angle with respect to a longitudinal axis of the shaft.

[0068] 17. The catheter of any of clauses 7-16, wherein the pull body inclined surface is inclined with respect to a longitudinal axis of the shaft, and the stator inclined surface is inclined in an angle smaller than the pull body inclined surface with respect to the longitudinal axis of the shaft.

[0069] 18. A method for delivering an implant by the catheter of any of clauses 7-17, the method comprising: holding the anchor between the pull body and the stator; positioning the catheter at a delivery location; and releasing the anchor from the catheter by moving the pull body proximally away from the stator such that the pull body inclined surface and the stator inclined surface are aligned.

[0070] 19. The method of any of clauses 7-18, further comprising: moving an outer shaft proximally with respect to an inner shaft to expose the implant from the catheter, the shaft including the inner shaft and the outer shaft surrounding the inner shaft.

[0071] 20. The method of any of clauses 7-19, further comprising: moving the catheter proximally with respect to the delivery location to release the anchor from the catheter.

[0072] It should now be understood that embodiments of the present disclosure are directed to catheters and methods for delivery of implants to hollow bodies. In some embodiments, the catheters and methods may be used to deliver the implants to blood vessels. More particularly, a catheter may be placed in a blood vessel to deliver an implant. For example, the catheter may include an implant delivery mechanism that holds the implant while the catheter is advanced through the blood vessel to a delivery location. The implant delivery mechanism may release the implant at the delivery location. The catheter is advanced through the blood vessel in a distal direction and the implant delivery mechanism releases by actuating a releasing mechanism in a proximal direction (e.g., pulling an actuating device (e.g., a wire) proximally to open a door that holds an anchor of the implant when closed, pulling the pull body proximally to release an anchor,or the like). The opposite arrangement between the direction to deliver the implant to the delivery location and the direction to release the implant at the delivery location may help reduce likelihood of implant delivery failure or positioning errors. Also, the implant delivery mechanism as stated above in embodiments of the present disclosure include simple mechanism by utilizing mechanical components which may simplify a design and a manufacture process, which may lead to reduction of cost.

[0073] It is noted that the terms 0 substantiallyO and 0 aboutO may be utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. These terms are also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.

[0074] While particular embodiments have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It is therefore intended that the appended claims cover all such changes and modifications that are within the scope of the claimed subject matter.

Claims

CLAIMS1. A catheter for delivering an implant, the catheter comprising: an inner shaft; an outer shaft surrounding the inner shaft; a door coupled to the inner shaft at a hinge; a biasing element biasing the door in a closed position to hold an anchor of the implant between the door and the inner shaft; and an actuation device coupled to the door, the actuation device configured to open the door when pulled to release the anchor from the catheter.

2. The catheter of claim 1, wherein: the biasing element is a torsion spring; and / or the actuation device disposed between the inner shaft and the outer shaft.

3. The catheter of claim 1, wherein the outer shaft is configured to move proximally with respect to the inner shaft to expose the implant from the catheter.

4. A method for delivering an implant by the catheter of claim 1, the method comprising: holding the anchor between the door and the inner shaft by biasing the door in the closed position by the biasing element; positioning the catheter at a delivery location; and releasing the anchor from the catheter by pulling the actuation device to open the door.

5. The method of claim 4, further comprising:moving the outer shaft proximally with respect to the inner shaft to expose the implant from the catheter.

6. The method of claim 4, further comprising: moving the catheter proximally with respect to the delivery location to release the anchor from the catheter.

7. A catheter for delivering an implant, the catheter comprising: a shaft; a pull body disposed in the shaft and proximally moveable with respect to the shaft, the pull body including a pull body inclined surface inclined proximally; and a stator disposed in the shaft, the stator including a stator inclined surface inclined proximally, wherein an anchor of the implant is held between the pull body and the stator, and the anchor is released when the pull body is moved proximally away from the stator such that the pull body inclined surface and the stator inclined surface are aligned.

8. The catheter of claim 7, wherein the pull body inclined surface and the stator inclined surface are aligned along a common plane when the pull body is moved proximally away from the stator to release to anchor.

9. The catheter of claim 7, wherein the pull body is coupled to an actuation device configured to move the pull body proximally with respect to the stator.

10. The catheter of claim 9, further comprising: a stop stopping the movement of the pull body at an alignment position where the pull body inclined surface and the stator inclined surface are aligned.

11. The catheter of claim 7, further comprising a biasing element configured to bias the pull body distally.

12. The catheter of claim 7, wherein the pull body inclined surface and the stator inclined surface radially overlap with each other when the anchor is held between the pull body and the stator.

13. The catheter of claim 7, wherein the stator includes a holding surface disposed radially opposite to the stator inclined surface, and the anchor is held between the holding surface and the pull body inclined surface.

14. The catheter of claim 7, wherein the shaft includes an inner shaft and an outer shaft surrounding the inner shaft, the outer shaft is configured to move proximally with respect to the inner shaft such that to expose the implant from the catheter.

15. The catheter of claim 14, wherein the stator is coupled to the inner shaft.

16. The catheter of claim 7, wherein the pull body inclined surface and the stator inclined surface are inclined in the same angle with respect to a longitudinal axis of the shaft.

17. The catheter of claim 7, wherein the pull body inclined surface is inclined with respect to a longitudinal axis of the shaft, and the stator inclined surface is inclined in an angle smaller than the pull body inclined surface with respect to the longitudinal axis of the shaft.

18. A method for delivering an implant by the catheter of claim 7, the method comprising: holding the anchor between the pull body and the stator;positioning the catheter at a delivery location; and releasing the anchor from the catheter by moving the pull body proximally away from the stator such that the pull body inclined surface and the stator inclined surface are aligned.

19. The method of claim 18, further comprising: moving an outer shaft proximally with respect to an inner shaft to expose the implant from the catheter, the shaft including the inner shaft and the outer shaft surrounding the inner shaft.

20. The method of claim 18, further comprising: moving the catheter proximally with respect to the delivery location to release the anchor from the catheter.

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