Percutaneous Implant Delivery System

Abstract

It has a structural design that enhances delivery and deployment performance, is ergonomic in use, compact and robust. SOLUTION: The present invention relates to an artificial implant catheter delivery system. The delivery system includes a handle, a capsule, a tip, and a catheter assembly. The catheter assembly includes an outer shaft, a stabilizing shaft, a catheter shaft, an inner shaft, and a guidewire shaft, where the catheter shaft and the inner shaft (in combination with the guidewire shaft) are utilized in loading, positioning, and deploying the implant. Only the stabilizing shaft is fixed. The handle includes a screw-based primary and secondary rotation mechanism. The secondary rotation mechanism also includes a push-pull mechanism. The delivery system has improved pushability and controllability.

Description

[Technical field]

[0001] The present invention relates to an implant delivery system and method for positioning and delivering an artificial implant using a percutaneous implant catheter delivery system. [Background technology]

[0002] The proper functioning of different organs is essential for the proper functioning of the human or animal body. However, due to factors such as age, disease, infection or genetic disease, the working efficiency of the organs decreases significantly and many times, which can be a serious and potentially life-threatening condition. For example, the human heart has four valves, and one common disease that occurs in the valves is calcification, which leads to abnormal hardening and narrowing of the flow area of ​​the valve, which restricts the blood flow, for example, in the case of aortic valve stenosis, the flow area of ​​the aortic valve is reduced and restricts the blood flow from the ventricle into the aorta. The aorta is the main artery that supplies blood to different parts of the human body, and therefore aortic valve stenosis can lead to death. To treat such diseases, the deployment of artificial implants is one widely accepted medical procedure.

[0003] Traditionally, implant replacement has been an open surgery in which the operator must open the relevant part of the patient to access a particular organ, e.g., opening the chest cavity to access the heart. However, in recent years, alternative, less invasive transcatheter approaches have been developed that deliver artificial implants transvascularly, e.g., via the femoral artery, transapically, transaortically, transaxillarily, etc., using catheters.

[0004] Transvascularly deliverable artificial implants usually include a compressible and expandable frame made of metals, alloys, non-metals, shape memory alloys, biological tissues, polymeric materials, or combinations thereof. The compressibility and expandability of the frame or stent allows it to be transported through the narrow diameter of the artery, and its material properties and structural design keep it stable and fixed at the deployment site. However, during the procedure, the implant delivery system plays a key role, as the operator's steering action at the proximal end (handle) of the delivery system directly affects the positioning, movement of the distal section (tip and capsule), and the performance of the implant after deployment. Current technology describes many techniques and mechanisms to perform this procedure with better trackability, pushability (force transmission), flexibility, precise positioning, etc. Prior art also provides knowledge on using different materials to have lower friction and lower profile. However, catheters for transvascular implant replacement still have some drawbacks in terms of trackability, pushability, shearing / researing, and robustness, which directly affect the positioning and performance of the artificial implant during and after deployment. The positioning of the artificial implant is directly related to pushability, i.e., force transmission from the handle to the tip region, and shearing / researing, i.e., capsule movement over the compressed implant.

[0005] Therefore, there is a need to provide a catheter delivery system for transvascularly deliverable prosthetic implants to avoid the drawbacks known in the art, specifically to provide a catheter delivery system with improved delivery and deployment performance, ergonomic in use, compact and robust structural design. Another object of the present invention is to provide an improved sheathing / reseathing prosthetic implant delivery system by providing a combination of more accurate macro movement to the capsule over the compressed implant and micro movement to the implant for its deployment. Summary of the Invention

[0006] The subject technology is illustrated, for example, in accordance with various aspects as set forth below.

[0007] According to one aspect of the invention, a percutaneous catheter for delivering an implant comprises a main rotation knob engaged with a threaded wheel by a screw thread. The threaded wheel is connected to a main screw shaft. The main screw shaft is a hollow cylinder with a continuous helical groove cut on its outer circumferential surface. A casing is attached to the handle housing and contains the main screw shaft inside the casing. At least one casing slot is provided on the outer circumferential surface of the casing. An indicator pin connected to the catheter shaft and engaged in the helical groove of the main screw shaft, whereby the indicator pin protrudes through the casing slot and is only movable in the longitudinal direction. A catheter shaft, one end of which is connected to the indicator pin and the other end of which is attached to the capsule. The catheter shaft moves longitudinally upon longitudinal movement of the indicator pin due to rotational movement of the main screw shaft caused by rotation of the main rotation knob.

[0008] The above aspects are further illustrated in the drawings and described in the corresponding description below. It should be noted that the description and drawings are merely illustrative of the principles of the invention. Thus, various configurations embodying the principles of the invention, although not explicitly described or shown herein, can be devised from the following description and are included within its scope. [Brief description of the drawings]

[0009] The detailed description will now be made with reference to the accompanying drawings. [Figure 1] FIG. 1 illustrates an isometric view of a transcatheter delivery system, in accordance with one embodiment of the present invention. [Figure 1A] FIG. 1 shows a detailed view of a capsule assembly in a distal section (away from the handle) of a transcatheter delivery system with the capsule in a loaded state, according to one embodiment of the present invention. [Figure 1B] FIG. 1 shows a detailed view of a capsule assembly in a distal section (away from the handle) of a transcatheter delivery system with the capsule unloaded, in accordance with one embodiment of the present invention. [Diagram 2] FIG. 1 shows an expanded view of a transcatheter delivery system depicting different components used in assembling the catheter system, according to one embodiment of the present invention. [Diagram 3] FIG. 1 is a side view of a transcatheter delivery system, according to one embodiment of the present invention. [Figure 3A] FIG. 1 is a cross-sectional view of a transcatheter delivery system, in accordance with one embodiment of the present invention. [Figure 3B] FIG. 1 shows an enlarged cross-sectional view of a proximal section of a transcatheter delivery system depicting the connections of different components used in assembling the catheter system, in accordance with one embodiment of the present invention. [Figure 4] FIG. 1 shows an isometric view of a handle of a transcatheter delivery system depicting a main screw shaft and a casing, according to one embodiment of the present invention. [Figure 4A] FIG. 1 shows a side view of a handle of a transcatheter delivery system depicting a main screw shaft and casing, according to one embodiment of the present invention. [Diagram 5] FIG. 1 illustrates an isometric view of a secondary rotation knob assembly of a transcatheter delivery system, in accordance with one embodiment of the present invention. [Figure 5A] FIG. 1 illustrates a top view of a secondary rotation knob assembly of a transcatheter delivery system, in accordance with one embodiment of the present invention. [Figure 6] FIG. 1 illustrates an isometric view of a push-pull cap attachment for a transcatheter delivery system, according to one embodiment of the present invention. [Figure 6A] FIG. 1 illustrates a cross-sectional side view of a push-pull cap attachment for a transcatheter delivery system, according to one embodiment of the present invention. [Figure 7] FIG. 1 illustrates a cross-sectional side view of a release button of a transcatheter delivery system, according to one embodiment of the present invention. [Figure 7A]FIG. 1 illustrates a top view of an indicator system of a transcatheter delivery system, in accordance with one embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The present disclosure provides one embodiment of a catheter delivery system, specifically a catheter for transvascular delivery and deployment of an artificial implant in a human or animal body. The catheter comprises a distal section, a mid-section, and a proximal section. The proximal section comprises a handle housing that remains outside the human / animal body and contains a mechanism for controlling movement in the distal section of the catheter. The distal section comprises a tip and a capsule assembly, which in a loaded state contains the artificial implant. The mid-section is connected proximally to the handle housing and distally to the distal section.

[0011] The intermediate section is located between the handle housing and the capsule assembly. The intermediate section comprises a plurality of concentric shafts, all of which span at least a quarter of the total length of the intermediate section. The intermediate section has a guidewire shaft, an inner shaft, a catheter shaft, a stabilization shaft, and an outer shaft. The guidewire shaft is the innermost shaft and passes concentrically through the inner shaft. The guidewire shaft and the inner shaft are connected via several crimp points on their circumferential surface areas. Both the guidewire shaft and the inner shaft start at the proximal most side of the proximal section, the guidewire shaft extends to the distal most side of the distal section, and the inner shaft extends to the proximal side of the distal section. The inner shaft passes concentrically through the catheter shaft. Similarly, the catheter shaft passes concentrically through the stabilization shaft, which is concentrically located inside the outer shaft. Thus, cross-sectionally from the center across the length of the mid-section to the point where all the shafts are present, the order of the shafts is guidewire shaft, inner shaft, catheter shaft, stabilization shaft, and outer shaft, and all of the shafts have a common center point.

[0012] One end of the guidewire shaft, the inner shaft, the catheter shaft, and the stabilization shaft remain connected to the distal side of the proximal section, the handle housing, while the outer shaft is not connected to the distal side of the proximal section (the handle housing) and can slide over the stabilization shaft. The end of the outer shaft closer to the distal side of the proximal section includes a hub through which the outer shaft can be fixed over the length of the stabilization shaft. The other end of the outer shaft and the stabilization shaft are not connected to any element of the catheter delivery system.

[0013] The distal section of the catheter delivery system mainly comprises a capsule assembly, a tip, and an inner shaft. The capsule assembly includes a capsule, which is a cylindrical structure, an implant holding area, and at least an implant holder. The implant holding area is the space inside the capsule where the artificial implant is loaded in a compressed form, and the capsule keeps the implant in a compressed form until it moves to expose the artificial implant for expansion and deployment via the delivery mechanism. The implant holder is a hub-like cylindrical structure fixed on the inner shaft and located inside the capsule at the end toward the proximal section. The implant holder has three projections on its outer periphery, which are at equal circumferential distances and angles from each other. These projections are for engaging the implant when loading it and disengaging it when deploying it. The inner shaft extends from the middle section, passes through the capsule, and ends near the proximal side of the distal section. As mentioned above, the inner shaft is concentrically equipped with a guidewire shaft. The tip is an atraumatic structure, a combination of a cylindrical section and a conical section. The cylindrical portion of the tip enters inside the capsule and the conical portion locks against the capsule, completely closing the opening of the capsule in the loaded configuration.

[0014] The capsule of the distal section is seamlessly connected to the other end of the catheter shaft. The stabilization shaft does not extend to the distal section of the catheter delivery system, but terminates somewhere along the length of the catheter shaft. Similarly, the other end of the outer shaft also extends to the distal section of the catheter delivery system and terminates somewhere along the length of the stabilization shaft.

[0015] The proximal section primarily comprises a screw-based mechanism for inducing movement in the distal section, specifically for moving the capsule and inner shaft. The proximal section is the handle of the catheter delivery system that remains outside the animal or human body. The handle comprises a handle housing, a handle housing cap, a primary screw shaft, a casing, a threaded wheel, a primary rotation knob, an indicator slot, an indicator pin, a ratchet spring, a ratchet collar, a release button, and a push-pull assembly that comprises a push-pull button, a secondary rotation knob, a secondary screw shaft, and a push-pull cap.

[0016] The catheter shaft extends proximally from the mid-section into the handle and is secured to the catheter hub. The catheter hub further comprises an indicator pin. The main screw shaft is a hollow shaft with a helically grooved groove cut on its outer circumferential surface. The groove is deep enough to communicate with the hollow cylindrical portion of the main screw shaft. The catheter hub is received in the hollow portion of the main screw shaft. The main screw shaft is further disposed within a casing. The casing is a hollow cylinder with a longitudinal casing slot on its outer circumferential surface area. The indicator pin attached to the catheter hub is received in a sufficiently wide helical groove formed on the outer periphery of the main screw shaft. The main screw shaft is attached to the casing, which is attached to the handle housing such that the main screw shaft is rotatable about its axis. However, longitudinal movement of the main screw shaft is limited. The handle housing comprises an indicator slot that coincides with one of the longitudinal casing slots, and the indicator pin passes through the groove on the main screw shaft, the casing slot, and the indicator slot.

[0017] Upon rotating the main screw shaft, the indicator pin moves longitudinally within the indicator slot due to the constraint of axial rotation. During longitudinal movement, the indicator pin also travels within the helical groove of the main screw shaft due to the rotation of the main screw shaft. Depending on the direction of rotation, the indicator pin moves toward or away from the main rotation knob. Furthermore, the indicator pin is connected to a catheter hub, which also moves linearly with the indicator pin within the main screw shaft as the main screw shaft rotates. Furthermore, the catheter hub is connected to the catheter shaft. Thus, the catheter shaft also moves longitudinally upon rotating the main screw shaft.

[0018] In addition, the outer peripheral surface area of ​​the main screw shaft, excluding the grooves, has protrusions perpendicular to the outer peripheral surface area. Opposite these screw shaft protrusions, the casing has slots for accommodating these protrusions. These protrusion slots are designed to occupy the screw shaft protrusions so that there is no relative movement between the casing and the main screw shaft.

[0019] The proximal end of the main screw shaft is attached to a ratchet collar having a number of sockets arranged in a circular pattern off-center on the proximal side of the cross section. Opposite this collar is a ratchet wheel having a number of cogs arranged in a circular pattern off-center on the distal side of the cross section. The cogs are designed to be received in sockets on the ratchet collar so as not to move loosely. The cogs and sockets are tapered on at least one side so that the ratchet wheel disengages from the ratchet collar when the movement of the indicator pin is restricted relative to the rotation of the main rotation knob. This is possible due to the arrangement of a ratchet spring behind the ratchet wheel towards the main rotation knob. The ratchet spring abuts against the ratchet wheel on the distal side and is located on the threaded wheel on the proximal side. The threaded wheel has threads partially on its outer circumference towards the proximal side. The threaded wheel is connected to the main rotation knob by these threads. The other end of the threaded wheel is connected to the ratchet wheel. In normal function, the ratchet wheel is fixedly connected to the ratchet collar, which in turn is fixedly connected to the main screw shaft. However, in the situation where the indicator pin cannot move towards the main rotation knob due to the limited rotation of the main screw shaft, the cog of the ratchet wheel disengages from the slot of the ratchet collar due to the tapered shape of the cog and slot. The cog always remains in contact with the cross section of the ratchet collar due to the continuous force applied to the ratchet wheel by the ratchet spring. The cog slides out of the socket and moves into the next socket due to the continuous force applied to the ratchet wheel by the ratchet spring. This mechanism provides additional safety and indication of deployment during the procedure by generating an audible sound, which also acts as a feedback mechanism. The operator performing the procedure receives feedback on the movement of the main screw shaft in three ways. The first feedback is essentially visual, where the indicator pin stops moving over the indicator slot, and the position of the indicator pin provides information as well.The second type of feedback is tactile in nature, where disengagement of the ratchet wheel from the ratchet collar is felt by the operator due to a change in the force required to rotate the main rotation knob. The third feedback medium is sound, where additional rotation of the main rotation knob after disengagement of the ratchet wheel and ratchet collar produces an audible sound indicating that the main screw shaft is not moving on its axis due to their constant contact.

[0020] Yet another safety mechanism employed in the catheter delivery system is the implementation of a release button. The release button is attached to the handle housing by a hinge. The hinge divides the release button into two parts, the button and the arm. When the button is pressed, the arm moves upwards. When the button is released, the button returns to its original position by a spring located under the button. The free end of the arm also has a spring-supported shock damper that provides a cushioning effect for the indicator pin. The release button is located inside the handle housing such that the free end of the arm enters the indicator pin's path of travel, restricting the indicator pin's travel at a predetermined location. For further movement of the indicator pin, the release button must be pressed, thereby lifting the arm out of the indicator pin's path of travel and providing an unrestricted path of travel to the indicator pin.

[0021] Furthermore, the handle housing has a housing cap that is threadably connected to the proximal end of the handle housing, and the housing cap has the required space at its center and its cross-sectional sides to accommodate other elements.

[0022] In addition, the catheter delivery system has a secondary rotation mechanism connected to the inner shaft and located behind the proximal end of the handle. The secondary rotation mechanism includes a secondary screw shaft, a secondary rotation knob, and a push-pull assembly including a pull shaft, a push-pull button, two connectors, and a push-pull cap. The pull shaft is attached to the push-pull cap. The push-pull shaft is located inside the hollow cavity of the threaded wheel, but the push-pull shaft is not connected to the threaded wheel or the handle housing. The push-pull cap has two connectors, and one end of each connector is attached to a push-pull button located on the outer circumferential surface of the push-pull cap. The two push-pull buttons are located at a distance of 180° from each other, i.e., the push-pull buttons are located opposite each other, and each is provided with a spring for moving the push-pull buttons back to their original positions after being pressed. When the push-pull button is pressed, the other end of the connector moves radially away from its original position, i.e., toward the center of the push-pull cap. The other end of the connector includes a stopper protruding outward from the center of the push-pull cap. By pressing both push-pull buttons located on the outer periphery of the push-pull cap, the other ends of the connector move inward toward the center of the push-pull cap, and these other ends of the connector are inserted into the inside of the handle housing cap through the space formed on the cross-section side. After insertion, the other ends of the connector return to their original position when the push-pull buttons are released. The stopper located on the other end of the connector engages with the inner structure of the housing cap, and the push-pull cap is fixedly connected to the housing cap, and then connected to the handle housing.

[0023] Furthermore, the secondary screw shaft is threadedly engaged with the secondary rotation knob, which is also fixedly connected to the inner shaft. The secondary rotation knob is located proximal to the push-pull cap, but is not attached to the push-pull cap. When the secondary rotation knob is rotated, the inner shaft moves longitudinally in either a forward or rearward direction based on the direction of rotation of the secondary rotation knob. The movement of the inner shaft relative to the capsule caused by the rotation of the secondary rotation knob is useful in fine adjustments required during loading, positioning, or deployment of the artificial implant. Also, to quickly move the inner shaft relative to the capsule, the push-pull cap can be disengaged from the housing cap by pressing the push-pull button and pulling the secondary rotation mechanism toward the operator. The secondary rotation knob is located proximal to the push-pull cap, and due to the rearward movement of the push-pull cap, the secondary rotation knob also moves rearward, and then the inner shaft also moves relative to the capsule.

[0024] The inner shaft starts at the proximal-most end of the secondary screw shaft, passes through the secondary rotation knob, the push-pull cap, the push-pull shaft, the main screw shaft, the catheter shaft, and ends near the proximal side of the distal section. The proximal-most end of the secondary screw shaft is used as a port for inserting a guidewire, which travels its entire length and exits the tip on the other end. Additionally, there is also a guide rail on the outer periphery of the secondary screw shaft that prevents unwanted rotation of the secondary screw shaft.

[0025] The catheter delivery system according to an embodiment of the present disclosure utilizes two movement mechanisms for loading, positioning, and deployment of the artificial implant. The catheter shaft is connected with the main screw shaft via a catheter hub. Upon rotating the main rotation knob, the catheter hub moves linearly inside the main screw shaft due to engagement with a helical groove on the outer peripheral surface area of ​​the main screw shaft, and the main screw shaft is restricted from any movement on the longitudinal axis. The backward or forward movement of the catheter shaft depends on the direction of rotation of the main rotation knob. The distal end of the catheter shaft has a capsule assembly in which the artificial implant is loaded in a compressed form using a specially designed loading device. In the loaded state, the implant resides inside the capsule on the guidewire shaft in the implant holding area, and one end of the implant engages with the implant holder.

[0026] The secondary rotation mechanism allows the inner shaft to be moved during fine adjustment using the secondary screw shaft, or a push-pull mechanism can be used to quickly move the inner shaft together with the guidewire shaft.

[0027] During deployment, the main rotation knob is used to move the catheter shaft backwards to expose the artificial implant. An indicator pin is connected to the catheter hub connected to the catheter shaft, which indicates the extent to which the implant is exposed on a scale displayed on the handle housing. After the artificial implant is deployed to a certain extent, for example 70%, the indicator pin hits the release button and the operator knows through the visual, tactile and audible mechanisms described above that he needs to press the release button. To this extent that the implant is exposed, the deployment process can be reversed, the implant can be recaptured inside the capsule, or the implant can be retrieved from the human or animal body. If the operator decides to further expose the implant from the capsule, he activates the release button. Pressing the release button lifts the limit in front of the indicator, allowing the catheter hub to move more freely. Once the implant is fully exposed, it automatically disengages from the implant holder and deploys at the deployment location.

[0028] According to another embodiment of the present disclosure, the implant can be, but is not limited to, a stent, a valve, a mesh, a balloon, a patch, a drug-containing matrix, a shunt, or a combination thereof.

[0029] According to yet another embodiment of the present disclosure, the different elements of the assembly, all or selected elements, are connected using adhesives, sealants, glues, screws, welding, other mechanical connecting means known in the art, other chemical connecting means known in the art, or combinations thereof.

[0030] According to yet another embodiment of the present disclosure, the push-pull button may have a variety of configurations or mechanisms attached to the push-pull cap, including but not limited to a hook, a screw, a locking pin, a switch (on / off), a Velcro base, a magnetic base, or combinations thereof.

[0031] According to yet another embodiment of the present invention, the implant is used in the treatment of any abnormality or any medical procedure related to the heart, kidney, liver, brain, pancreas, lungs, digestive system, endovascular system, any tract, duct, or any conduit in the animal or human body. More specifically, the implant can be deployed in the arteries, veins, heart valves, esophageal tract, bile duct, urinary tract, digestive tract, tracheobronchial tree, cerebral aqueduct, or genitourinary system of the animal or human body.

[0032] Referring now to the drawings, where elements are labeled with like numbers throughout the several views, reference is further made to the accompanying drawings which form a part hereof, and in which are shown by way of illustration specific embodiments in which the present 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.

[0033] 1, according to one embodiment of the present disclosure a catheter delivery system (100). The catheter delivery system comprises a distal section (400), an intermediate section (300), and a proximal section (200). The proximal end (200) comprises a handle housing (112) that remains outside the human body and contains mechanisms for controlling movement at the distal end of the catheter.

[0034] The mid-section (300) is located between the handle housing (112) and the capsule assembly (166). The mid-section comprises an inner shaft (104) with a permanently attached guidewire shaft (103), a catheter shaft (106), a stabilization shaft (107), and an outer shaft (108). All shafts are concentrically arranged, i.e., arranged cross-sectionally from the center over the length of the mid-section at the point where all shafts reside, and the order of shafts is: guidewire shaft (103), inner shaft (104), catheter shaft (106), stabilization shaft (107), and outer shaft (108). The catheter shaft (106) extends from the tip (101) to the handle housing (112). The stabilization shaft (107) remains connected to the handle housing and extends over the catheter shaft (106), while the outer shaft (108) is not connected to the handle housing (112) and is slidable over the stabilization shaft (107). The outer shaft (108) includes a hub (114) to which the outer shaft (108) can be secured over the length of the stabilization shaft (107).

[0035] The distal section (400) of the catheter delivery system (100) mainly comprises a capsule assembly (166), a tip (101), and a guidewire shaft (104). The capsule assembly (166) includes a capsule (102), an implant holding area (168), and an implant holder (170). The distal end capsule (102) is seamlessly connected to the other end of the catheter shaft (106). The implant holding area (168) is the space inside the capsule (102) where the artificial implant is loaded in a compressed form. The implant holder (170) is a hub-like cylindrical structure fixed on the inner shaft (104) and located inside the capsule (102). The implant holder (170) has three protrusions on its outer circumferential surface to engage with the implant when loaded. The inner shaft (174) extends from the intermediate section (300) and terminates proximally near the distal section (400).

[0036] The proximal section (200) primarily comprises a screw-based mechanism for inducing movement in the distal section (400). The proximal section is the handle (110) comprising the handle housing (112), the handle housing cap (144) with the required space at its center and cross-sectional sides to accommodate other elements, the primary screw shaft (116), the casing (118), the threaded wheel (122), the primary rotation knob (124), the indicator slot (136), the indicator pin (138), the ratchet spring (120), the ratchet collar (140), the release button (132), and the push-pull assembly (160) comprising the push-pull button (126), the secondary rotation knob (128), the secondary screw shaft (130), and the push-pull cap (164).

[0037] One end of the catheter shaft (106) is seamlessly connected to the capsule (102), and the other end is fixed to a catheter hub (146). The catheter hub (146) further comprises an indicator pin (138) which is engaged in a helical groove cut on the outer periphery of a hollow cylindrical main screw shaft (116). The main screw shaft (116) is disposed in a casing (118) having longitudinal casing slots (148) on its outer periphery surface area. The indicator pin (138) passes through one of the longitudinal casing slots (148). The main screw shaft (116) is rotatable about its axis, but its longitudinal movement is restricted. When the main screw shaft (116) is rotated, the indicator pin (138) moves longitudinally in the casing slot (148). Based on the direction of rotation, the indicator pin (138) moves either toward or away from the main rotation knob (124). The movement of the indicator pin (138) also causes the catheter hub (146) to move longitudinally, thereby moving the connected catheter shaft (106). The movement of the catheter shaft (106) moves the capsule (102) backwards or forwards, based on the direction of rotation of the main rotation knob (124). This movement plays a key role in retaining and compressing the compressed prosthetic implant and releasing the prosthetic implant for deployment.

[0038] Additionally, for slight movement, fine positioning and deployment of the prosthetic implant, a secondary rotation mechanism connected to the inner shaft (104) and removably located behind the handle (110) of the catheter delivery system (100) can be utilized. The secondary rotation mechanism comprises a secondary screw shaft (130), a secondary rotation knob (128), and a push-pull assembly comprising a pull shaft, a push-pull button (126), two connectors (172), and a push-pull cap (164).

[0039] A secondary screw shaft (130) is fixedly connected to the inner shaft and is also threadably engaged with the secondary rotation knob (128). Rotation of the secondary rotation knob causes the inner shaft to move longitudinally in either a forward or rearward direction depending on the direction of rotation of the secondary rotation knob.

[0040] The push-pull shaft (162) attached to the push-pull cap (164) is located inside the threaded wheel (122)'s compliance cavity but is not connected to the threaded wheel (122) or the handle housing (112). The push-pull cap (164) is attached to the handle housing cap (144) via two connectors (172) and can be removed from the handle housing cap (144) using the push-pull button (126). The secondary rotation knob (128) is located proximal to the push-pull assembly (160) but is not attached to the push-pull cap (164). When the push-pull cap (164) is removed from the handle housing cap (144) and pulled toward the operator, the secondary rotation knob (128) also moves, which in turn moves the inner shaft rearward.

[0041] The push-pull assembly (160) is for causing fast, small movements in the inner shaft, while the secondary rotation knob (128) is for causing slow, small movements in the inner shaft. One end of the secondary screw shaft is used as a guidewire port (154) for inserting a guidewire. A guide rail (180) prevents undesired rotational movements of the secondary screw shaft (130).

[0042] Additionally, the catheter delivery system has three safety and feedback mechanisms: visual, audio, and tactile. The movement of the indicator pin (138) can be seen on the indicator scale (178), which is a visual feedback mechanism. In addition, the main screw shaft (116) is attached to a ratchet wheel (134) supported by a ratchet collar (140) and a ratchet spring (120), which stops transmitting rotational force from the main rotation knob (124) to the main screw shaft (116) when a certain degree of movement of the indicator pin (138) is reached. This occurs due to disengagement between the ratchet collar (140) and the ratchet wheel (134) due to the design of the cog (176) and socket (174). However, due to the continuous force applied by the ratchet spring (120), the rotational force from the main rotation knob (124) is converted into an audible sound that provides feedback to the operator. However, the most important element that stops the movement of the indicator pin (138) is the release button (132). The release button (134) is placed at a predefined calibrated location in the longitudinal path of the indicator pin (138). This location is determined based on the degree of prosthetic implant deployment before retrieval of the prosthetic implant is permitted. The release button (134) is hinged at one point and acts as a lever. Depressing the release button (134) with one end of the lever displaces the other end of the release button from the path of the indicator pin (138). When the indicator pin (138) impacts the other end of the release button, tactile feedback is felt by the operator. Additionally, when the ratchet collar and ratchet wheel disengage, sensory feedback is provided to the operator due to a change in the rotational force applied by the operator.

[0043] In the above description, for the purpose of explanation, specific details are 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 can be practiced without these details. Those skilled in the art will recognize that although one of the embodiments of the present disclosure is described below, the embodiments of the present disclosure can be incorporated into several systems. Furthermore, the structures and devices shown in the figures are illustrative of the exemplary embodiments of the present disclosure and are intended to avoid obscuring the present disclosure. [Explanation of symbols]

[0044] [Table 1]

Claims

1. 1. A percutaneous catheter for delivering an implant, comprising: a main rotary knob engaged with a threaded wheel by a screw thread, The threaded wheel is connected to a main screw shaft, the main screw shaft being a hollow cylinder with a continuous spiral groove cut on its outer periphery; a main rotation knob, the main screw shaft being a hollow cylinder with a continuous spiral groove cut on its outer periphery; a casing attached to the handle housing and containing the main screw shaft therein; at least one casing slot provided on the outer peripheral surface of the casing; an indicator pin connected to the catheter shaft and engaged in the helical groove of the main screw shaft, the indicator pin protruding through the casing slot and movable only in a longitudinal direction; the catheter shaft has one end connected to the indicator pin and the other end attached to a capsule; and Equipped with the catheter shaft moves longitudinally upon longitudinal movement of the indicator pin due to rotational movement of the main screw shaft caused by rotation of the main rotation knob. A percutaneous catheter for delivering the implant.

2. 10. The percutaneous catheter for implant delivery of claim 1, further comprising a push-pull assembly comprising a secondary rotation knob engaged by a screw thread with a secondary screw shaft, the secondary screw shaft being connected to an inner shaft, and rotational movement of the secondary rotation knob causing longitudinal movement of the inner shaft.

3. The percutaneous catheter for implant delivery of claim 1 , further comprising a handle attached at a proximal end to the handle housing.

4. 3. The percutaneous catheter for implant delivery of claim 2, further comprising a push-pull cap comprising at least one push-pull button that engages with a handle housing cap to attach the push-pull assembly to the handle housing.

5. The percutaneous catheter for implant delivery of claim 2 , wherein the secondary screw shaft includes at least one guide rail for controlling rotational movement of the secondary rotation knob.

6. 3. The percutaneous catheter for implant delivery of claim 1 or 2, wherein the push-pull assembly is detachable from the handle housing by actuating the push-pull button.

7. 10. The percutaneous catheter for implant delivery of claim 1, further comprising an indicator slot on the handle housing that provides a travel path for the indicator pin for longitudinal movement upon rotation of the main rotating shaft.

8. a release button for restricting movement of the indicator pin at a predetermined location; 10. A percutaneous catheter for delivering an implant according to claim 1.

9. 10. The percutaneous implant delivery catheter of claim 1, further comprising a ratchet wheel connected to the threaded wheel, the ratchet wheel maintained in engagement with a ratchet collar attached to the main screw shaft by a ratchet spring disposed between the threaded wheel and the ratchet wheel.

10. 2. The percutaneous implant delivery catheter of claim 1, further comprising at least one screw shaft protrusion on an outer peripheral surface of the main screw shaft, the screw shaft protrusion engaging with at least one protrusion slot on an inner peripheral surface of the casing.

11. 10. The percutaneous catheter for implant delivery of claim 1, comprising an indicator scale indicating the extent of implant delivery by movement of the indicator pin along the indicator scale.

12. The percutaneous catheter for implant delivery of claim 1 , further comprising an implant holder attached to the other end of the inner shaft.

13. 10. The percutaneous catheter for implant delivery of claim 1, comprising at least one radiopaque marker on the outer circumferential surface of the component selected from the tip, the capsule, the implant holder, or a combination thereof.

14. 2. The percutaneous catheter for implant delivery 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.

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