Percutaneous catheter system for implant delivery

Abstract

Transvascular delivery and deployment of an implant in a living body. **SOLUTION**: The present invention relates to a catheter system for implant delivery. The delivery system includes a primary rotation knob and a secondary rotation knob. The primary rotation knob moves the catheter shaft to load or unload the implant, while the secondary rotation knob is connected to the inner shaft. The inner shaft comprises an implant holder that engages the implant during loading and unloading. Movement of the inner shaft by rotation of the secondary rotation knob improves positioning of the implant and ensures separation of the implant from the implant holder by a small movement of the implant holder.

Description

Technical Field

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

Background Art

[0002] A healthy heart, along with healthy arteries, veins, valves, nodules, 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 operating efficiency of the cardiovascular system significantly decreases, which is a serious and potentially life-threatening condition. Conventionally, surgery has been one of the main options for dealing with severely affected organs or parts thereof, for example, replacing the affected organ or part thereof with a mechanical implant, bypassing the affected organ or part thereof, or removing the affected organ or part thereof using the harvested organ or part thereof. However, in recent years, alternative minimally invasive transcatheter approaches have been developed, which use a percutaneous catheter to deliver an implant, and the percutaneous catheter can be navigated transvessally to a target position through various access points within the vascular network, for example, through the femoral artery, transapically, transaortically, transaxillary, etc. These implants may be, but are not limited to, stents, valves, meshes, balloons, patches, drug-containing matrices, shunts, or combinations thereof.

[0003] During transvascular procedures, the catheter system used to deliver implants plays a crucial role because the operator's maneuvering at the proximal end (handle) of the delivery system directly affects the positioning, movement, and performance of the distal section (tip and capsule) and the implant after deployment. The effects of the maneuvering are transmitted from the proximal end to the distal end through the catheter shaft, which is located between the proximal and distal ends. However, sometimes implants are not quickly removed from the delivery system, requiring additional manipulation that increases the time required to complete the medical procedure and often reduces the accuracy of implant positioning.

[0004] Therefore, in order to avoid the drawbacks known in the art, there is a need to provide a catheter system for implant delivery for transvascular delivery of implants, specifically, a catheter system for implant delivery that improves implant positioning and ensures implant removal. In addition, the catheter system for implant delivery should be ergonomic in use and have a robust structural design. Another object of the present invention is to provide a catheter system for implant delivery that has better implant removal by providing a movable implant holder. [Overview of the project]

[0005] The present invention will be described according to the various embodiments described below.

[0006] According to one aspect of the present invention, a percutaneous catheter for implant delivery comprises a primary rotation knob connected to the catheter shaft to cause longitudinal movement of the catheter shaft. A secondary rotation knob is connected to an inner shaft to cause longitudinal movement of the inner shaft, the secondary rotation knob being connected to a threaded wheel, the threaded wheel engaging with the secondary rotation knob via threads. An eccentric luer having a guidewire port is connected to the guidewire shaft. At least one luer arm is connected to the eccentric luer, positioned radially apart, and the luer arm parallel to the longitudinal axis passes through the center of the guidewire port and the guidewire shaft. At least a groove is cut into the threaded wheel longitudinally and is accessible from at least one cross-section of the threaded wheel. The luer arm passes through the groove of the threaded wheel, and the threaded wheel moves longitudinally on the luer arm during the rotational movement of the secondary rotation knob.

[0007] The above embodiments are further shown in the drawings and described in the corresponding descriptions below. It should be noted that the descriptions and drawings are merely illustrative of the principles of the present invention. Therefore, various configurations encompassing the principles of the present invention, which are not explicitly described or illustrated herein, can be conceived from the description and are included within its scope. [Brief explanation of the drawing]

[0008] Detailed explanations are provided with reference to the attached diagrams. [Figure 1] This is a side view of a transcatheter system for implant delivery, according to one embodiment of the present invention, in which the capsule is in a retracted position. [Figure 1A] This is a side view enlarged of a secondary rotation knob of a transcatheter system for implant delivery according to an embodiment of the present invention. [Figure 2] This is an isometric view of various components used when assembling a secondary rotation knob for a transcatheter system for implant delivery according to an embodiment of the present invention (safety pin is not shown here). [Figure 2A]This is a side view of a secondary rotation knob of a transcatheter system for implant delivery according to an embodiment of the present invention. [Figure 2B] This is an isometric view of a secondary rotation knob of a transcatheter system for implant delivery according to an embodiment of the present invention. [Figure 3] This is a side cross-sectional view of a secondary rotation knob of a transcatheter system for implant delivery according to an embodiment of the present invention. [Modes for carrying out the invention]

[0009] This disclosure provides a catheter system for implant delivery, specifically an embodiment of a catheter for transvascular delivery and deployment of an implant in a living organism, such as a human or animal body. The catheter comprises a distal section, an intermediate section, and a proximal section. The proximal section remains outside the living organism and includes a handle that incorporates a mechanism for controlling the movement of the catheter in the distal section. The distal section comprises an implant holder, a tip, and a capsule assembly, the capsule assembly of which, in the loaded state, holds the implant on a guidewire shaft. The intermediate section is connected to the handle proximal and to the distal section distally.

[0010] The intermediate section is located between the handle and the capsule assembly. The intermediate section comprises multiple concentric shafts, all of which extend for at least one-quarter of the total length of the intermediate section. The intermediate section has at least a guidewire shaft, an inner shaft, and a catheter shaft. The guidewire shaft is the innermost shaft and passes concentrically through the inner shaft. The guidewire shaft begins at the nearest end of the proximal section and extends to the most distal end of the distal section. The inner shaft begins at the nearest end of the proximal section and extends to the beginning of the distal section, or to where the capsule begins in its fully advanced state. The inner shaft passes concentrically through the catheter shaft. Therefore, cross-sectionally, across the length of the intermediate section at the point where at least the three shafts described above exist, the order of the shafts from the center is the guidewire shaft, the inner shaft, and the catheter shaft, and all shafts have a common center point.

[0011] The proximal section features a handle equipped with a primary and secondary rotation knob, the secondary rotation knob connected to a threaded wheel, which engages with an eccentric Luer. The primary rotation knob is connected to a threaded mechanism to cause movement in the distal section, specifically to move the capsule, which is the distal portion of the catheter shaft. Rotation of the secondary rotation knob causes movement of the inner shaft in the longitudinal direction, while the guidewire shaft remains stationary, fixed to the eccentric Luer. Both the primary and secondary rotation knobs are located within the handle housing. The handle housing is also part of the handle, providing protection for the mechanism causing the movement and also providing a grip for the user.

[0012] The secondary rotation knob is fixed within the handle housing and cannot move longitudinally. The secondary rotation knob is a cylindrical structure with threads on its inner circumference. These internal threads engage the secondary rotation knob with a threaded wheel. The threaded wheel is also a cylindrical structure with threads on its outer circumference. The threaded wheel also has a hole in its center. The diameter of the hole is larger than the outer diameter of the inner shaft. The proximal end of the inner shaft is connected to the hole. Therefore, as the secondary rotation knob rotates, the threaded wheel moves longitudinally toward or away from the tip, depending on the direction of rotation of the secondary rotation knob. As described above, the inner shaft is connected to the threaded wheel. Therefore, as the threaded wheel moves longitudinally, the inner shaft also moves longitudinally accordingly.

[0013] Furthermore, the threaded wheel has at least one groove cut in the longitudinal direction. The groove is accessible from at least one cross-section of the threaded wheel. According to one embodiment of the present disclosure, the width of the groove is variable in the circumferential direction, and in the upper limit, the width can be sufficiently wide so that the threaded wheel does not lose its ability to move longitudinally by the rotational motion of the secondary rotating knob.

[0014] Furthermore, the threaded wheel engages with the eccentric lure through a groove. The eccentric lure has at least one guide wire port and at least one lure arm, the guide wire port being aligned with the center of the threaded wheel. However, the lure arm is mounted to the lure such that its longitudinal axis is parallel to the longitudinal axis passing through the center of the guide wire port and the hole, but the longitudinal axis of the lure arm is located at a radial distance from the longitudinal axis passing through the center of the hole. The eccentric lure engages with the groove through the lure arm. The lure arm also functions as a guide rail for the threaded wheel, and the length of the lure arm is sufficient to support the threaded wheel while it moves longitudinally. When the parts are assembled, the eccentric lure does not move, and the engagement of the lure arm with the groove restricts the rotational movement of the threaded wheel. Therefore, when the secondary rotation knob is turned, the threaded wheel moves only longitudinally.

[0015] Furthermore, the eccentric luer's guidewire port is connected to the guidewire shaft. The guidewire shaft is also hollow and, as described above, extends from the guidewire port located on the nearest side of the proximal section to the most distal end of the tip. The hollow guidewire shaft provides an access route for the guidewire during medical procedures. The guidewire shaft is fixed to the catheter system for implant delivery and does not move longitudinally.

[0016] Furthermore, according to another embodiment of the present invention, a safety mechanism is provided to lock the movement of the secondary rotary knob. The safety mechanism comprises a safety pin and a safety slot, which, when engaged, lock the movement of the secondary rotary knob. The safety slot can be designed on the circumferential surface or cross-section of the secondary rotary knob, or it can exist as a projection on any surface of the secondary rotary knob. The safety pin can be detachable from the handle or can be attached to the handle and can communicate with the safety slot in either an engaged or disengaged state.

[0017] According to one embodiment of the present disclosure, the safety pin is a removable pin, and the safety slot is a hole in the cross-section of the secondary rotary knob. Inserting the safety pin into the safety slot restricts the rotational movement of the secondary rotary knob, thereby restricting the longitudinal movement of the inner shaft.

[0018] A catheter system for implant delivery according to embodiments of this disclosure utilizes two movement mechanisms for loading, positioning, and deploying an artificial heart valve. The catheter shaft is connected to a primary rotation knob, and as the primary rotation knob is rotated, the catheter shaft moves along its longitudinal axis. The backward or forward movement of the catheter shaft depends on the direction of rotation of the primary rotation knob. The distal end of the catheter shaft has a capsule in which the implant is loaded onto the guidewire shaft in a compressed form. Backward movement of the catheter shaft causes backward movement of the capsule, which releases the implant for deployment. The inner shaft is attached to an implant holder, which engages with the implant during loading of the implant into the capsule and remains engaged until backward movement of the capsule releases the implant for deployment. The inner shaft moves along its longitudinal axis as the secondary rotation knob is rotated. The longitudinal movement of the inner shaft causes longitudinal movement of the implant holder. The movement of the implant holder ensures the separation of the implant from the catheter system for implant delivery.

[0019] According to yet another embodiment of the present disclosure, the implant may 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.

[0020] According to yet another embodiment of the present disclosure, the inner shaft is connected to the bore via adhesive, sealant, glue, thread, welding, or a combination of other mechanical, chemical, or both types of connecting means known in the art.

[0021] According to yet another embodiment of the present disclosure, at least additional elements can be disposed between the guide wire shaft and the inner circumference of the guide wire port to strengthen the connection between the guide wire port and the guide wire shaft. Similar elements can also be disposed between the inner shaft and the inner circumference of the pore to strengthen the connection therebetween. The additional elements may be made of metal, non-metal, alloy, polymer, wood, natural fiber, synthetic fiber, or a combination thereof. The physical form of the additional element is selected from a hollow circular ring, a hollow cylinder, a ring having at least one angle on the inner or outer circumference, a ring having a thread on the inner or outer circumference, a ring having at least one protrusion on the inner or outer circumference, or a combination thereof.

[0022] According to yet another embodiment of the present disclosure, the safety mechanism can be of various configurations, specifically selected from, but not limited to, screw-type, hook-type, locking pin-type, switch-type (on / off type), magic tape-based, magnetic-type, or a combination thereof.

[0023] <着 According to yet another embodiment of the present disclosure, the catheter system for implant delivery includes a display mechanism for indicating the degree of implant delivery during an implant delivery procedure.

[0024] According to yet another embodiment of the present disclosure, the catheter system for implant delivery includes at least a radiopaque marker on a distal section including a tip, a guide wire shaft, a capsule, and an inner shaft to indicate the location of a specific element of the loaded implant when the implant is in a human or animal body.

[0025] According to yet another embodiment of the present invention, the implant is used in the treatment of any abnormality or medical procedure relating to the heart, kidneys, liver, brain, pancreas, lungs, digestive system, intravascular system, any tube, conduit, or any conduit in the body of an animal or human. More specifically, the implant can be placed in an artery, vein, heart valve, esophagus, bile duct, urinary tract, digestive tract, tracheobronchial tree, cerebral aqueduct, or urogenital system in the body of an animal or human.

[0026] By combining the different materials and design modifications described above, various configurations with diverse structural-property relationships can be obtained.

[0027] Referring here to the figures, the elements are numbered similarly throughout several of the figures. Furthermore, refer to the accompanying drawings illustrating, as examples, specific embodiments that form part of this specification and can carry out the invention. It should be understood that other embodiments may be used, and structural modifications may be made without departing from the scope of the invention.

[0028] Refer to Figures 1 and 1A of embodiments of the catheter system (100) for implant delivery in this disclosure. The catheter system for implant delivery comprises a distal section (400), an intermediate section (300), and a proximal section (200). The proximal end (200) includes a handle (110) that remains outside the body and incorporates a mechanism for controlling the movement of the distal end of the catheter within a handle housing (112). The distal end (400) comprises a tip (101), a capsule (102) which is the distal portion of a catheter shaft (103), an implant holder (109) connected to the distal end of an inner shaft (104), and a portion of a guidewire shaft (106) that houses an implant (not shown).

[0029] The intermediate section (300) is located between the handle (110) and the implant holder (109). The intermediate section comprises at least an inner shaft (104), a guidewire shaft (103), and a catheter shaft (106). All shafts are arranged concentrically, that is, cross-sectionally from the center over the length of the intermediate section at the point where all shafts are present, and the order of the shafts is the guidewire shaft (103), the inner shaft (104), and the catheter shaft (106).

[0030] The proximal section (200) comprises a handle (110) having a primary rotation knob (116) and a secondary rotation knob (118). Both knobs are fixed longitudinally, but both knobs are rotatable about their own axes. Rotation of the primary rotation knob (116) causes longitudinal movement of the catheter shaft (106) from the implant holder (109) to the tip (101), thereby loading or unloading an implant that is housed on a portion of the guidewire (103) and between the implant holder (109) and the tip (101). Both the primary rotation knob (116) and the secondary rotation knob (118) are located within the handle housing (112).

[0031] Refer to Figures 2, 2A, 2B, and 3, according to one embodiment of the implant delivery catheter system (100) of the present disclosure. The secondary rotating knob (118) has an internal thread (122) that engages with a threaded wheel (120) through threads on its outer circumference. The threaded wheel (120) has two longitudinally cut grooves (124) that engage with an eccentric luer (126) through the grooves (124). The two luer arms (128) of the eccentric luer (126) pass through the grooves (124).

[0032] The threaded wheel (120) also has a hole (121) on its cross section (120), and the proximal end of the inner shaft (104) is connected to this hole (121). Furthermore, the eccentric lure (126) also has a guide wire port (114) which is connected to the guide wire shaft (103). The lure arm (128) acts as a guide rail for the threaded wheel (120) to move longitudinally along the lure arm (128).

[0033] The rotational movement of the secondary rotation knob (118) causes the longitudinal threaded wheel (120) to move, and the inner shaft (104) also moves longitudinally accordingly. The guide wire shaft (103) is fixed to the eccentric lure (126) and remains stationary.

[0034] Therefore, rotating the primary rotation knob (116) causes a large movement, exposing the housed implant for deployment. Rotating the secondary rotation knob (118) causes a smaller movement that further improves the positioning of the implant, ensuring separation of the implant from the implant holder due to longitudinal movement of the implant holder.

[0035] In addition, the secondary rotary knob (118) is equipped with a safety pin (130) that engages with a safety slot (132) located on the cross section of the secondary rotary knob (11) to restrict undesirable movement of the secondary rotary knob (118).

[0036] The above description includes specific details for illustrative purposes to provide an understanding of the disclosure. However, it will be apparent to those skilled in the art that the disclosure can be implemented without these details. Those skilled in the art will recognize that embodiments of the disclosure (one of which is described below) can be incorporated into several systems. Furthermore, the structures and devices shown in the drawings are illustrative of exemplary embodiments of the disclosure and are intended to avoid obscuring the disclosure. [Explanation of Symbols]

[0037] Table 1

Claims

1. A percutaneous catheter for implant delivery, A primary rotation knob connected to the catheter shaft, which facilitates longitudinal movement of the catheter shaft, A secondary rotating knob connected to an inner shaft to facilitate longitudinal movement of the inner shaft, the secondary rotating knob being connected to a threaded wheel, the threaded wheel engaging with the secondary rotating knob via threads, An eccentric lure having a guide wire port connected to a guide wire shaft, At least one lure arm connected to the eccentric lure and positioned at a radial distance, the at least one lure arm parallel to the longitudinal axis and passing through the center of the guide wire port and the guide wire shaft, The threaded wheel comprises at least a groove cut longitudinally into the threaded wheel and accessible from at least one cross-section of the threaded wheel, A percutaneous catheter for implant delivery, wherein the Luer arm passes through the groove in the threaded wheel, and the threaded wheel moves longitudinally on the Luer arm during the rotational motion of the secondary rotation knob.

2. The percutaneous catheter for implant delivery according to claim 1, wherein the threaded wheel is provided with a pore connected to the inner shaft.

3. The percutaneous catheter for implant delivery according to claim 2, wherein an additional element is present between the inner circumference of the pore and the outer circumference of the inner shaft.

4. The percutaneous catheter for implant delivery according to claim 1, wherein an additional element exists between the inner circumference of the guidewire port and the outer circumference of the guidewire shaft.

5. The percutaneous catheter for implant delivery according to any one of claims 1 to 4, wherein the additional elements are connected to different elements by adhesive, sealant, glue, screws, welding, or a combination thereof.

6. The percutaneous catheter for implant delivery according to claim 1, wherein the material of the additional element is selected from metals, nonmetals, alloys, polymers, wood, natural fibers, synthetic fibers, or a combination thereof.

7. The percutaneous catheter for implant delivery according to claim 1, wherein the physical shape of the additional element is selected from a hollow circular ring, a hollow cylinder, a ring having at least one angle on its inner or outer circumference, a ring having a thread on its inner or outer circumference, a ring having at least one projection on its inner or outer circumference, or a combination thereof.

8. The percutaneous catheter for implant delivery according to claim 1, further comprising a safety mechanism for locking the movement of the secondary rotation knob.

9. The percutaneous catheter for implant delivery according to claim 9, wherein the safety mechanism comprises a safety pin and a safety slot, and when the safety pin and the safety slot are engaged, they lock the movement of the secondary rotation knob.

10. The percutaneous catheter for implant delivery according to claim 9, characterized in that the safety mechanism is selected from a screw type, hook type, locking pin type, switch type (on / off type), Velcro type, magnetic type, or a combination thereof.

11. The percutaneous catheter for implant delivery according to claim 1, wherein the implant is selected from a stent, valve, mesh, balloon, patch, drug-containing matrix, shunt, vena cava filter, vascular graft, stent graft, or a combination thereof.

12. A percutaneous catheter for implant delivery according to claim 1, comprising a display mechanism indicating the degree of implant delivery.

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

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