Implant separation mechanism

Abstract

To impart accuracy and efficiency to the separation and deployment of the implant. **Solution**: The present invention features an implant holder (102) for the retention and controlled release of an implant from a delivery catheter (100). The implant holder (102) is disposed within the distal region of the delivery catheter (100). The implant holder (102) engages the implant in a constricted state to inhibit axial and radial displacement of the implant. The implant holder (102) includes specific invariant features with respect to a uniquely designed release portion (124) and a pusher block (112) that are adapted to accommodate the implant in a unique manner and disengage it from the delivery catheter.

Description

Technical Field

[0001] The present invention relates to a percutaneous implant delivery system and method for delivering an implant into the body of a human or animal. Specifically, the present invention relates to an implant separation mechanism for assisting in the deployment of coronary or peripheral artery implants.

Background Art

[0002] For the human or animal body to function properly, it is essential that various organs function properly. For example, a healthy heart, along with healthy arteries, veins, implants, joints, walls, and other components, is essential for the proper functioning of other organs and the cardiovascular system itself. However, due to factors such as age, disease, infection, or genetic disorders, the efficiency of organ function can be significantly reduced and sometimes lead to serious and life-threatening conditions. Conventionally, one of the main options for dealing with severely affected organs has been surgery, for example, replacing a diseased valve with a mechanical implant or bypassing or removing an occluded artery using a removed artery, etc. However, in recent years, alternative minimally invasive transcatheter approaches have been developed, using a transcutaneous catheter to deliver implants transvascularly through various access points within the cardiovascular network, such as transapically, transaortically, transaxillary, etc., via the femoral artery. These implants may be, but are not limited to, stents, valves, meshes, balloons, patches, drug-containing matrices, shunts, or combinations thereof.

[0003] During a transvascular procedure, the operator's actions at the proximal end (handle) of the delivery system directly affect the positioning, movement, and performance of the implant after deployment in the distal region (tip and capsule). Therefore, the catheter delivery system that carries the implant plays a crucial role. The effect of the actions is transmitted from the proximal end through the catheter shaft to the distal end. The catheter shaft is located between the proximal and distal ends. However, sometimes, the implant does not separate quickly from the delivery system, additional operations are required, consuming more time, and the positioning accuracy of the implant may also decrease.

[0004] Therefore, in order to avoid the drawbacks known in the art, it is necessary to provide a separation mechanism for the catheter delivery system for transvascular delivery of the implant, specifically, to provide a catheter delivery system that gives accuracy and efficiency to the separation and deployment of the implant. SUMMARY OF THE INVENTION

[0005] The subject technology is described, for example, according to various aspects described below.

[0006] According to one aspect of the present invention, an implant separation mechanism for separating an implant from an implant holder includes a catheter, the catheter having a guide wire shaft, an inner shaft, a handle, and a rotating knob. A release block and a pusher block are combined to form the implant holder. The release block has a separation end with an impact surface, the pusher block has at least one pin, the pusher block is fixed to the inner shaft, and the release block is fixed to the guide wire shaft. Relative movement between the inner shaft and the guide wire shaft causes the release block and the pusher block to move closer to or away from each other. The pin is used to engage the implant. When the pusher block and the release block are moved towards each other, at a certain point, the impact surface at the separation end of the release block impacts the pin, and the resulting impact force contributes to the separation of the engaged implant from the pin.

[0007] According to another aspect of the present invention, an implant separation mechanism for separating an implant from an implant holder includes a catheter, the catheter having a guide wire shaft, an inner shaft, a rotating knob, and a handle. A release block including at least one leg and a pusher block including at least one sliding slot are combined to form the implant holder, and the leg and the sliding slot are arranged to slide. Further, the release block includes a release portion having a symmetric or asymmetric shape along its length. When the release block is moved towards the pin, a force perpendicular to the engaging portion of the implant frame is applied due to the symmetric or asymmetric shape of the release portion, and as the release block approaches the pin, the engaging portion disengages from the pin. In one alternative arrangement, the pusher block is movable by a longitudinally movable inner shaft, and when the pusher block is moved, the pin moves towards the release block, and a force perpendicular to the engaging portion of the implant frame is applied due to the linear or non-linear shape of the release portion, and as the release block approaches the pin, the engaging portion disengages from the pin.

[0008] According to yet another aspect of the present invention, an implant separation mechanism for separating an implant from an implant holder includes a catheter, which has a guide wire shaft, an inner shaft, a rotary knob, and a handle. A riser, a receiving portion, and a movable pin are combined to form the implant holder. The riser and the receiving portion have at least one inclined end. The riser and the receiving portion are fixed on the guide wire shaft, and their inclined ends face each other. The movable pin consists of a cylindrical portion and a hook. The cylindrical portion is slidable within a slot of the inner shaft. The hook has two inclined surfaces. The hook is positioned without a fixed connection between the riser and the receiving portion, and each inclined surface of the hook conforms to the inclined surfaces of the riser and the receiving portion. Depending on the direction of the longitudinal movement of the guide wire shaft, the rotational movement of the rotary knob within the handle causes the cylindrical portion of the movable pin to move vertically through the slot within the inner shaft, and the inclined surfaces of the hook slide on the inclined surfaces of the riser and the receiving portion.

[0009] The above aspect is further illustrated in the drawings and described in the corresponding description below. It should be noted that the description and the drawings merely illustrate the principles of the present invention. Therefore, various arrangements that are not explicitly described or illustrated in this specification but that embody the principles of the present invention can be devised from this description and are included within the scope of the present invention.

Brief Description of the Drawings

[0010] A detailed description will be given with reference to the accompanying drawings.

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Mode for Carrying Out the Invention

[0011] According to the present disclosure, in some embodiments, a catheter delivery system for transvascularly delivering and deploying an implant into a human or animal organ includes a separation mechanism that securely detaches the implant from the catheter delivery system after the implant has reached the deployment location and has been placed in the correct position. By definition, the separation of the implant from the catheter delivery system is an event where the implant can no longer be manipulated thereafter and the next process step of retracting the catheter from the deployment site begins.

[0012] In one non-limiting aspect, a typical catheter delivery system includes a distal region, an intermediate region, and a proximal region. The proximal region remains outside the human body and includes a handle housing that includes a mechanism for controlling the movement of the distal region of the catheter. The distal region includes a tip, an inner shaft, a guide wire shaft, an implant holder, and a capsule, and in the loaded state, the distal region also includes an implant. The intermediate region is connected proximally to the handle housing and distally to the distal region.

[0013] The capsule is a hollow cylindrical portion that is located in the intermediate region and is movable through a movement mechanism actuated from the proximal region. The capsule provides an internal space in which the implant is loaded in a compressed form, and also serves to hold the implant in the compressed form. Typically, a capsule-based catheter delivery system is used for delivering an implant whose frame structure is made of a shape memory alloy such as nitinol. No external force is required for such an implant to return to its uncompressed structure. Due to its shape memory properties, when the capsule moves and exposes the implant from one end, such an implant reaches its normal structure from that end. The implant extends over the guide wire shaft and is positioned between the tip and the implant holder. The inner shaft extends longitudinally along the intermediate region from the proximal end of the distal region and further to the proximal end of the proximal region. The guide wire shaft extends from the proximal end of the proximal region to the distal end of the distal region. The guide wire shaft is connected to a threaded shaft and to a rotary knob. The inner shaft is fixed to the handle housing and is not movable. However, by rotating the rotary knob, the threaded shaft moves longitudinally, which in turn moves the guide wire shaft. In one alternative arrangement, the inner shaft is connected to the threaded shaft, and the threaded shaft is connected to the rotary knob. In this case, the guide wire shaft is fixed to the handle housing and is not movable. However, by rotating the rotary knob, the threaded shaft moves longitudinally, which in turn moves the inner shaft.

[0014] When the implant is loaded into the capsule on the guide wire shaft, the engaging portion of the frame of the implant engages with the pin of the implant holder. In the loading procedure of the implant, the capsule is moved to compress the implant and accommodate it inside the hollow cylindrical portion of the capsule. During the deployment procedure, the capsule is moved to expose the implant, and the engaged portion of the frame of the implant returns to its original shape. In normal operation, this is sufficient to disengage the implant from the frame holder. However, in some cases, further operations are required to securely separate the implant frame.

[0015] The implant holder is a hub-shaped cylindrical part consisting of two parts and is located inside the capsule at the proximal end of the distal region. The pushable block, which is the first part of the implant holder, is attached to the inner shaft, and the release block, which is the second part, is attached to the guide wire shaft. The distal side of the pushable block has a plurality of pins on its outer peripheral surface. These pins are, optionally, equidistant and at equal angles to each other in the circumferential direction. The distal side of the release block of the implant holder is fixed to the guide wire shaft. The proximal side of the pushable block of the implant holder is fixed to the inner shaft. The proximal side of the release block has a plurality of legs, and any two legs have a space therebetween for accommodating at least one pin located on the distal side of the pushable block. The pushable block has at least one sliding slot for slidably accommodating at least one leg of the release block. In the assembled state, the legs are accommodated in the sliding slots, and when the guide wire shaft is moved, the release block moves longitudinally, and the legs move within the sliding slots. In one alternative arrangement, in the assembled state, the inner shaft is movable longitudinally and the guide wire shaft is fixed. In this arrangement, when the inner shaft is moved, the pushable block moves longitudinally and the release block is fixed. However, even in this configuration, the accommodation of the legs in the sliding slots remains the same, and the sliding movement of the legs within the sliding slots also remains the same. Usually, the pushable block has a plurality of sliding slots, the release block has a plurality of legs, and these legs are slidably accommodated within the sliding slots.

[0016] In another embodiment, the release block does not have legs that are accommodated within the sliding slots of the pushable block. However, the release block has a surface or notch that contacts the outer peripheral surface of the pin when the guide wire shaft or the inner shaft is moved.

[0017] Furthermore, a portion of the release block includes at least one leg, at least one release portion along the length of that portion, and at least one separation end. The release portion and the separation end, either combined or alone, constitute a separation mechanism for separating the engaging portion of the frame from the pin. The length of the release portion is sufficient to remain in contact with the outer peripheral surface of the pin during the movement of the guide wire shaft or the inner shaft. Further, the height of the pin is lower than or approximately equal to the height of the separation end. The separation end is positioned facing the distal side of the release block and is connected to the release portion, and the release portion is connected to the leg. The impact surface of the separation end that contacts the pin can be selected from a flat surface, an inclined surface, a curved surface, a concave surface, a convex surface, a V-shaped notch, a U-shaped notch, an elliptical surface, an oval surface, an irregular geometric surface, or a combination thereof. Similarly, the edge along the length of the release portion can be selected from a tapered edge, a curved edge, a concave edge, a convex edge, an elliptical edge, an edge where the width of the leg changes in at least one step in the circumferential direction, an irregular geometric edge, or a straight or non-straight edge selected from a combination thereof, and can have various shapes. In any case where the edge of the release portion is a non-straight edge, the direction of the non-straight edge is such that the degree of non-linearity increases towards the proximal region of the catheter delivery system or towards the separation end. In another embodiment, the degree of non-linearity is evenly distributed along the length of the release portion.

[0018] In use, the pins engage the implant frame during loading of the implant and disengage during deployment. As described above, in some cases, for various reasons, the implant does not disengage quickly and further manipulation is required to separate the implant. This lengthens the procedure time and may also affect the positioning of the implant. The two-part implant holder mechanism according to the present disclosure serves to reliably separate the implant frame from the pins of the implant holder of the catheter delivery system. Moving the guide wire shaft causes the release block of the implant holder to also move longitudinally, and the release portion also moves. The movement path is from one end of the release portion to the other end of the release portion. In the initial position, the pins are away from the separation end, and the engaging portion of the implant frame is engaged with these pins. The engagement mechanism simply hooks at least a portion of the implant frame onto the pins. Moving the release block causes the separation end to move towards the pins, and a force perpendicular to the engaging portion of the implant frame is applied due to the straight or non-straight shape of the release portion, and as the separation end approaches the pins, the engaging portion disengages from the pins. In one alternative arrangement, the pusher block is movable by an internal shaft movable longitudinally, and moving the pusher block causes the pins to move towards the separation end, and a force in the perpendicular direction is applied to the engaging portion of the implant frame due to the straight or non-straight shape of the release portion, and as the separation end approaches the pins, the engaging portion disengages from the pins.

[0019] In another embodiment where there are no legs and / or release portions, moving the guide wire shaft causes the release block to move and the separation end impacts the outer peripheral surface of the pins. This sudden impact or influence causes the engaging portion of the frame to separate from the pins.

[0020] According to yet another embodiment of the present disclosure, the guide wire shaft is fixed and not longitudinally movable. Accordingly, the release block attached to the guide wire shaft is also fixed. The pusher block of the implant holder is attached to the inner shaft, and the pin is located on the distal end of the pusher block. According to this embodiment, the inner shaft is longitudinally movable. Accordingly, the pusher block is also movable. When the inner shaft is moved, the pin attached to the pusher block also moves along the release portion present on the release block, disengaging the engaging portion of the implant frame from the pin.

[0021] According to yet another embodiment of the present disclosure, the separation end does not play a functional role during separation, and only the release portion in the release block functions. Depending on the arrangement, when moving the release block by longitudinal movement of the guide wire shaft or moving the pusher block by longitudinal movement of the inner shaft, the release portion provides an upward force, and this force acts on the engaging portion of the frame to separate the frame from the pin.

[0022] Furthermore, the pusher block optionally has a seating notch that provides a space around the pin for accommodating the engaging portion of the frame. Also, the seating notch creates a pressing surface that helps to transmit force from the catheter shaft to the engaging portions of the implant holder and the frame. The force is applied longitudinally by the physician towards the distal region of the catheter delivery system, and while the pressing surface applies force to the engaging portion of the frame, the outer peripheral surface of the pin provides a base support.

[0023] In another embodiment, there are no legs and release portions within the release block. When the pin located on the pusher block is moved, it contacts the impact surface of the separation end due to the movement of the inner shaft, and the engaging portion of the frame is separated from the pin by this sudden impact or influence.

[0024] According to yet another embodiment of the present disclosure, the pin is vertically movable through a slot in the inner shaft. According to this embodiment, the implant holder comprises three parts, namely a movable pin, a riser, and a receiver. The riser is attached to the inner shaft and has an inclined surface facing the proximal region of the catheter delivery system. The receiver is also attached to the inner shaft and has another inclined surface. This other inclined surface faces the distal region of the catheter delivery system. The movable pin is positioned between the riser and the receiver. The shape of the movable pin consists of a cylindrical portion and a hook portion. The engaging portion of the implant frame engages with the cylindrical portion of the movable pin. To disengage the implant from the movable pin, the movable pin is vertically moved using the riser, the receiver, and the longitudinal movement of the guide wire shaft. The hook portion of the movable pin is a parallelogram positioned at an angle with respect to the longitudinal axis of the guide wire shaft. One end of the hook portion is fixed to the cylindrical portion of the movable pin, and the other end is positioned between the riser and the receiver such that one side surface of the parallelogram is in sliding contact with the inclined surface of the riser and the other side surface is in sliding contact with the inclined surface of the receiver. Also, the inclined surface of the riser and the inclined surface of the receiver are parallel to each other, that is, when approaching, the inclined surface of the riser and the inclined surface of the receiver contact each other at an angle of 0°. Also, the hook portion of the movable pin is not fixed to any surface. When the guide wire shaft moves longitudinally towards the distal region, the receiver moves forward and forces the hook portion of the movable pin towards the guide wire shaft. When the guide wire shaft moves forward, the receiver also moves forward and applies a downward force to the inclined surface of the flat portion. This downward force pushes the movable pin and moves it downward within the created space, and the cylindrical portion of the movable pin is received in the slot within the inner shaft. Similarly, when the guide wire shaft moves longitudinally towards the proximal region, the riser also moves towards the proximal region, applies an upward force to the other inclined surface of the flat portion, and helps the movable pin move upward through the slot of the inner shaft.

[0025] According to yet another embodiment of the present disclosure, the pins can be of various sizes and shapes, specifically selected from, but not limited to, rectangles, circles, D-shapes, ovals, hexagons, pentagons, octagons, triangular configurations, and combinations thereof.

[0026] The materials used to fabricate such cantilevers are selected from, but not limited to, stainless steel, nitinol, polyamide, polypropylene, acrylonitrile butadiene styrene, and combinations thereof.

[0027] According to yet another embodiment of the present invention, the implant holder includes at least one radiopaque marker. The radiopaque marker is located on the outer peripheral surface of the implant holder, and its components include, but are not limited to, a pusher block, a release block, a pin, a riser, a receiving portion, legs, sliding slots, slots, a release portion, or combinations thereof.

[0028] According to yet another embodiment of the present invention, the shape of the radiopaque marker present on the percutaneous catheter is selected from circles, rectangles, squares, ellipses, hexagons, oblongs, stars, diamonds, annuli, irregular-shaped annuli, incomplete annuli, incomplete irregular-shaped annuli, or combinations thereof.

[0029] According to yet another embodiment of the present invention, the implant is used in the treatment or medical procedure of abnormalities related to the heart, kidney, liver, brain, pancreas, lung, digestive system, intravascular system, passage, tube, or duct in the body of an animal or human. More specifically, the implant can be deployed in the arteries, veins, heart valves, esophagus, bile duct, urinary tract, digestive tract, tracheobronchial tree, cerebral aqueduct, or urogenital system of the body of an animal or human.

[0030] Additionally, the present subject matter also contemplates a method for fabricating an implant holder as described above. In this method, in order to manufacture the implant holder, it is necessary to load a medically clean and approved workpiece into a design instrument. According to an example of the present subject matter, the workpiece may be in the shape of a hollow circular tube, or a solid cylinder, or a sheet. In some embodiments, the workpiece is prepared from a composition in powder form or from a composition in liquid form. Then, the required design of the implant holder is set up or uploaded to a design instrument such as a computer numerical control (CNC) machine for manufacturing. Subsequently, the required design is cut out from the workpiece to manufacture the implant holder. In one example, the fabrication technique used in the design instrument is selected from laser shaping, chemical etching, mechanical machining, chemical machining, metal injection molding, vacuum casting, milling, photochemical etching, electrical discharge machining, 3D printing techniques, additive manufacturing techniques, or combinations thereof. For example, the implant holder is manufactured by longitudinally cutting open a metal hollow circular tube with a laser beam, and the laser beam generates the design of the implant holder according to a predetermined cutting contour. Alternatively, the implant holder is manufactured using 3D printing techniques or additive manufacturing. After the implant holder is manufactured, unnecessary materials are removed from the surface of the implant holder for finishing. The cleaned and finished implant holder may then be polished or coated with a suitable coating. For example, an anti-reactive agent can also be applied, which prevents the implant from reacting with the atmosphere at the location where the implant is stored or deployed. Additionally, or alternatively, the implant holder can be coated with a medical substance or a radiopaque substance depending on the purpose, mode, and location of the deployment of the implant holder.

[0031] 3D printing technology can be selected from, but is not limited to, stereolithography (SLA), digital light processing (DLP), fused deposition modeling (FDM), selective laser sintering (SLS), selective laser melting (SLM), electron beam melting (EBM), laminated object manufacturing (LOM), polyjet technology, or combinations thereof.

[0032] By combining the various materials and design variations described above, various configurations with various structure-property relationships can be obtained.

[0033] Referring now to the figures, elements are labeled with like numbers throughout several views. Further, the accompanying drawings are referenced, which form a part of this specification and illustrate, by way of example, specific embodiments in which the invention may be practiced. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present invention.

[0034] FIG. 1 depicts a typical catheter delivery system according to an embodiment of the present disclosure. The catheter delivery system (100) includes a distal region (160), an intermediate region (150), and a proximal region (140). The proximal region (140) remains outside the body and includes a handle (120) for controlling movement at the distal region (160) of the catheter. The distal region includes a tip (126), an inner shaft (104), a guidewire shaft (114), an implant holder (102), and a capsule (128). The intermediate region (150) is connected proximally to the handle (120) and distally to the distal region (160).

[0035] Figure 1A represents an enlarged view of a portion of a handle (120) assembly having a rotary knob (108). Figure 1B represents a side cross-sectional view of a portion of the handle (120) with the rotary knob (108). The rotary knob (108) is connected to a threaded shaft (106) fixed to a guide wire shaft (114). The guide wire shaft (114) passes through the inner shaft (104) and extends to a tip (126) within the distal section (160). The distal region (160) mainly comprises the tip (126), the guide wire shaft (114), the implant holder (102), and the capsule (128). The capsule (128) provides an internal space where the implant is loaded in a compressed form, and the capsule (128) serves to hold the implant in the compressed form. The implant is positioned across the guide wire shaft (114) between the tip (126) and the implant holder (102). The implant holder (102) is located on the guide wire shaft (114) and within the capsule (128) at the proximal end of the distal region (160). In this arrangement, the guide wire shaft (114) is longitudinally movable by the rotational movement of the rotary knob (108). Figure 1C represents a side cross-sectional view of a portion of the handle (120) with the rotary knob (108). The rotary knob (108) is connected to a threaded shaft (106) fixed to the inner shaft (104). The guide wire shaft (114) passes through the inner shaft (104) and extends to a tip (126) within the distal section (160). In this arrangement, the inner shaft (104) is longitudinally movable by the rotational movement of the rotary knob (108).

[0036] Referring to FIGS. 2 and 2A, according to one embodiment of the present disclosure, the implant holder (102) is a two-piece hub-shaped cylindrical structure, consisting of a pusher block (112), attached to an inner shaft (104), and a release block (116) attached to a guide wire shaft (114). The release block has a plurality of legs (130). The pusher block (112) has a plurality of pins (110) and a plurality of sliding slots (122). The legs (130) are arranged to slide within the sliding slots (122). Each pin (110) is disposed between two adjacent legs (130). Additionally, the pusher block (112) also has a seating notch (136) around the pin (110) that houses the engagement portion of the frame. Also, the shape of the seating notch creates a pressing surface (138) that aids in the transfer to the engagement portion of the frame, where a longitudinal force is applied by the physician to the catheter delivery system. In the assembled state, when the guide wire shaft (114) is moved, the release block (116) moves longitudinally and the legs (130) slide within the sliding slots (122). Further, at least one leg (130) has a release portion (124) having a symmetric or asymmetric shape along its length. The release portion (124) has a separation end (132) having a height approximately equal to the height of the pin. In application, the pin (110) engages the frame of the implant. When the guide wire shaft (114) is moved longitudinally, the release block (116) of the implant holder (102) also moves and the release portion (124) also moves. In the initial position, the pin (110) is away from the separation end (132). When the release block (116) is moved, the separation end (132) moves towards the pin (110), and due to the shape of the release portion (124), a force perpendicular to the engagement portion of the implant frame is applied, and as the separation end (132) approaches the pin (110), the engagement portion moves away from the pin (110).

[0037] According to the embodiment shown in FIGS. 2 and 2A, in the initial position, the separation end (132) faces the distal region (160) of the catheter delivery system.

[0038] According to the embodiment shown in FIG. 2B, the pusher block (112) has a pressing surface (138) and a seating notch (136) between the pin (110) and the pressing surface (138). FIG. 2C shows an impact surface (139) present at the separation end (138).

[0039] FIGS. 3 and 3A represent another embodiment of the present disclosure. In the initial position, the separation end (132) faces the proximal region (140) of the catheter delivery system.

[0040] Referring to FIGS. 4 and 4A, according to yet another embodiment of the present disclosure, the guide wire shaft (114) is fixed and not longitudinally movable. Accordingly, the release block (116) attached to the guide wire shaft (114) is also fixed. According to this embodiment, the rotary knob within the handle (120) is connected to a threaded shaft fixed to the inner shaft (104). The pusher block (112) of the implant holder (102) is also attached to the inner shaft (104). Thus, when the rotary knob is rotated, the inner shaft (104) is longitudinally movable and the pusher block (112) also moves. The pin (110) attached to the pusher block (112) also moves along the release portion (124) present on the release block (116) towards the separation end (132), disengaging the engaging portion of the implant frame from the pin (110). When the pusher block (112) is moved, the pin (110) moves towards the separation end (132), and the inclined shape of the release portion (124) applies a force perpendicular to the engaging portion of the implant frame, causing the engaging portion to disengage from the pin (110).

[0041] Referring to FIGS. 5 and 5A, according to another embodiment of the present disclosure, the inner shaft (104) is not movable, and thus the pin (110) attached to the pusher block (112) is also not movable. The guide wire shaft (114) is longitudinally movable by the rotational movement of the rotary knob (108). The release block (116) also moves longitudinally by the movement of the guide wire shaft (114), and the concave edge of the release portion (124) applies an upward force to the engaging portion of the frame to assist in separating from the pin (110).

[0042] FIGS. 6 and 6A illustrate yet another embodiment of the present disclosure, where the inner shaft (104) is not movable, and thus the pin (110) attached to the pusher block (112) is also not movable. The guide wire shaft (114) is longitudinally movable by the rotational movement of the rotary knob (108). The release block (116) also moves longitudinally by the movement of the guide wire shaft (114), and the straight edge of the release portion (124) that does not change in angle with respect to the longitudinal axis of the guide wire shaft applies a frictional force to the engaging portion of the frame to assist in its separation from the pin (110).

[0043] Referring to FIGS. 7 and 7A, according to yet another embodiment of the present disclosure, the inner shaft (104) is not movable, and thus the pin (110) attached to the pusher block (112) is also not movable. The guide wire shaft (114) is longitudinally movable by the rotational movement of the rotary knob (108). The release block (116) also moves longitudinally by the movement of the guide wire shaft (114), and the convex edge of the release portion (124) applies an upward force to the engaging portion of the frame to assist in separating from the pin (110).

[0044] Referring to FIGS. 8 and 8A, according to yet another embodiment of the present disclosure, the inner shaft (104) is not movable, and thus the pin (110) attached to the pusher block (112) is also not movable. The guide wire shaft (114) is longitudinally movable by the rotational movement of the rotary knob (108). The release block optionally has no legs and / or release portions. The release block (116) also moves longitudinally by the movement of the guide wire shaft (114), the U-shaped notch of the release portion (124) contacts the outer peripheral surface of the pin (110), and the impact surface (118) of the separation end (132) affects or impacts the pin, which helps to separate the pin (110) from the engaging portion of the frame.

[0045] Figures 9 through 9F illustrate yet another embodiment of the present invention, in which longitudinal movement of the guide wire shaft (114) causes the movable pin (170) to move perpendicular to the longitudinal axis through a slot (134) in the inner shaft (104). The movable pin (170) includes a cylindrical portion (176) and a hook portion (178). The hook portion (178) is parallelogram-shaped and has parallel inclined sides. These sides are in sliding contact with the riser (172) and the receiver (174). The riser (172) and the receiver (174) also have at least one inclined side, and they are also parallel to each other and parallel to the inclined sides of the hook portion (178). The riser (172) and the receiver (174) are in sliding contact with the inclined sides of the hook portion (178). Both the riser (172) and the receiver (174) are attached to the inner shaft (104), but the movable pin (170) is not fixed to any part of the catheter delivery system. One end of the cylindrical portion (176) is attached to the hook portion (178) and is disposed within the slot (134) of the inner shaft (104). The movable pin (170) is positioned between the riser (172) and the receiver (174). The engagement portion of the implant frame engages the cylindrical portion (176) of the movable pin (170). When the guide wire shaft (114) moves longitudinally toward the distal region (160), the receiver (174) moves forward, forcing the hook portion (178) of the movable pin (170) to move toward the guide wire shaft (114). When the guide wire shaft (114) moves forward, the receiver (174) also moves forward, applying a downward force to the inclined surface of the hook portion (178). This downward force pushes the movable pin (170) and moves it downward within the created space, and the cylindrical portion (176) of the movable pin (170) is received within the slot (134) in the inner shaft (104). Similarly, when the guide wire shaft (114) moves longitudinally toward the proximal region (140), the riser (172) also moves toward the proximal region (140), applying an upward force to the other inclined surface of the hook portion (178) to assist the upward movement of the movable pin (170) through the slot (134) in the inner shaft (104).

[0046] To disengage the engaging portion of the implant frame, the movable pin (170) is moved in a vertically downward direction using the vertical movement of the riser (172), the receiving portion (174), and the guide wire shaft (114). In the above description, for the purpose of explanation, specific details have been set forth to provide an understanding of the present disclosure. However, it will be apparent to those skilled in the art that the present disclosure may be practiced without these details. Those skilled in the art will recognize that embodiments of the present disclosure, one of which is described below, may be incorporated into several systems. Further, the structures and devices shown in the figures are illustrative of exemplary embodiments of the present disclosure and are intended to avoid obscuring the present disclosure.

Description of Reference Numerals

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Table 1

Claims

1. An implant detachment mechanism for detaching an implant from an implant holder, comprising: a catheter having a guidewire shaft, an inner shaft, a handle, and a rotation knob; a release block and a pusher block that combine to form the implant holder; the release block has a separation end with an impact surface; the pusher block has at least one pin that engages the implant; the pusher block is fixed on the inner shaft, the release block is fixed on the guidewire shaft, and relative movement between the inner shaft and the guidewire shaft moves the release block and the pusher block toward and away from each other; When the pusher block and the release block are moved toward each other, a force applied to the pin or the engaged implant facilitates separation of the engaged implant from the pin. Implant separation mechanism.

2. The implant detachment mechanism of claim 1 , wherein the release block has at least one leg having one end connected to the detachment end.

3. The implant detachment mechanism of claim 2 , wherein the pusher block has at least one sliding slot.

4. The implant detachment mechanism of claim 3 , wherein the legs are slidably received within the slide slots.

5. The implant detachment mechanism of claim 1 , wherein the legs have release portions with symmetrical or asymmetrical shapes along the lengths of the legs.

6. 2. The implant detachment mechanism of claim 1, wherein as the pusher block and the release block are moved toward each other, at some point the impact surface on the separation end of the release block impacts the pin, and the resulting impact force contributes to separating the engaged implant from the pin.

7. 2. The implant detachment mechanism of claim 1, wherein moving the pusher block and the release block toward one another causes the release portions of the legs to contact the engaged implant, thereby applying a force to the engaged implant that causes the implant to separate from the pin.

8. The implant detachment mechanism of claim 1 , wherein the inner shaft within the catheter is longitudinally movable upon rotation of the rotation knob present within the handle of the catheter.

9. The implant detachment mechanism of claim 1 , wherein the guidewire shaft within the catheter is longitudinally movable upon rotation of the rotation knob present within the handle of the catheter.

10. The implant detachment mechanism of claim 1 , wherein the implant holder has a plurality of legs attached to the release block and a plurality of sliding slots present in the pusher block.

11. The implant detachment mechanism of claim 1 , wherein the implant holder has a plurality of pins mounted at equal circumferential intervals on the pusher block.

12. The plurality of pins are attached to the pusher block at uneven intervals in the circumferential direction. The implant detachment mechanism of claim 1 .

13. 2. The implant detachment mechanism of claim 1, wherein the impact surface of the detachment end has a surface configuration selected from flat, curved, angled, concave, convex, elliptical, oval, V-notch, U-notch, C-notch, irregular surface, or combinations thereof.

14. 2. The implant detachment mechanism of claim 1, wherein the release portion of the leg has a straight or non-straight edge selected from a tapered edge, a curved edge, a concave edge, a convex edge, an elliptical edge, an edge that varies the width of the leg around the periphery by at least one step, an irregularly shaped edge, or a combination thereof.

15. 2. The implant detachment mechanism of claim 1, wherein the pin present on the pusher block has a peripheral shape selected from a rectangular, circular, D-shaped, oblong, hexagonal, pentagonal, octagonal, triangular configuration, and combinations thereof.

16. The implant detachment mechanism of claim 1 , wherein the pusher block has a pressing surface and a seating notch between the pressing surface and the pin to provide space for engaging the implant.

17. An implant detachment mechanism for detaching an implant from an implant holder, comprising: a catheter having a guidewire shaft, an inner shaft, a rotation knob, and a handle; a riser, a receiver, and a movable pin that combine to form the implant holder; the riser and the receiver have at least one beveled end, the riser and the receiver are fixed on the guidewire shaft, and the beveled ends of the riser and the receiver face each other; the movable pin comprises a cylindrical portion and a hook, the cylindrical portion being slidable within a slot in the inner shaft; the hook has two inclined surfaces, and the hook is positioned between the riser and the receiver without a fixed connection; the inclined surface of each of the hooks matches the inclined surfaces of the riser and the receiver; Depending on the direction of longitudinal movement of the guidewire shaft, rotational movement of the rotation knob within the handle causes the cylindrical portion of the movable pin to move vertically through the slot within the inner shaft and the angled surface of the hook to slide over the angled surfaces of the riser and receiver. Implant separation mechanism.

18. 10. The implant detachment mechanism of claim 1, made of a biocompatible material selected from the group consisting of polymers, metals, alloys, non-metals, biodegradable materials, bioabsorbable materials, or combinations thereof.

19. 10. The implant detachment mechanism of claim 1, made of a biocompatible material selected from the group consisting of polymers, metals, alloys, non-metals, biodegradable materials, bioabsorbable materials, or combinations thereof.

20. The implant detachment mechanism of claim 1 , wherein the implant holder is made of a biocompatible material selected from stainless steel, nitinol, cobalt chrome, polyamide, polypropylene, acrylonitrile butadiene styrene, or combinations thereof.

21. The implant detachment mechanism of claim 1 , wherein the implant holder has at least one radiopaque marker on a circumferential surface thereof.

22. 10. The implant detachment mechanism of claim 1, wherein the implant is selected from a stent, a valve, a mesh, a balloon, a patch, a drug-containing matrix, a shunt, a vena cava filter, a vascular graft, a stent-graft, or a combination thereof.

23. A method for manufacturing an implant holder according to any one of claims 1 to 22, comprising the steps of: setting up the design of the pusher block and the release block to be fabricated in a design machine; engraving the design onto a workpiece to produce the pusher block and the release block; finishing the pusher block and the release block by removing material from a surface of the pusher block and the release block and polishing the pusher block and the release block; matingly positioning the pusher block over the inner shaft and the release block over the guidewire shaft; securing the pusher block onto the inner shaft and the release block onto the guidewire shaft; A method comprising:

24. 24. The method of claim 23, wherein the workpiece is one of a hollow circular tube, a solid cylinder, or a sheet, or is prepared from a powder form of the composition, or is prepared from a liquid form of the composition.

25. 24. The method of claim 23, wherein the engraving is selected from at least one of laser shaping, chemical etching, mechanical machining, chemical machining, metal injection molding, vacuum casting, milling, photochemical etching, electrical discharge machining, 3D printing techniques, additive manufacturing techniques, or combinations thereof.

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