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 is significantly reduced, 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 transvascularly to a target location through various access points within the vascular network, for example, through the femoral artery, transapically, transaortically, transaxillarily, etc. 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, a catheter system for implant delivery that conveys an implant plays a crucial role because the operator's manipulation at the proximal end (handle) of the delivery system directly affects the positioning, movement, and performance of the implant after deployment at the distal section (tip and capsule). The effect of the manipulation is transmitted from the proximal end to the distal end through the catheter shaft. The catheter shaft is positioned between the proximal end and the distal end. However, sometimes the implant is not quickly removed from the delivery system, increasing the time required to complete the medical procedure and often requiring additional operations that reduce the positioning accuracy of the implant.

[0004] Accordingly, in order to avoid the drawbacks known in the art, it is necessary to provide a catheter system for implant delivery for transvascular delivery of an implant, specifically, to provide a catheter system for implant delivery that improves the positioning of the implant and ensures the removal of the implant. 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 with better implant removal by providing a movable implant holder. SUMMARY OF THE INVENTION

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

[0006] According to one aspect of the present invention, a percutaneous catheter for implant delivery comprises a primary rotary knob connected to the catheter shaft to cause longitudinal movement of the catheter shaft. A secondary rotary knob connected to the inner shaft to cause longitudinal movement of the inner shaft, the secondary rotary knob being connected to a threaded wheel, the threaded wheel being engaged with the secondary rotary knob via a thread. An eccentric luer having a guide wire port is connected to the guide wire shaft. At least one luer arm is connected to the eccentric luer and is disposed at a radial distance, and the luer arm parallel to the longitudinal axis passes through the center of the guide wire port and the guide wire shaft. At least a groove is cut longitudinally into the threaded wheel 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 rotation of the secondary rotary knob.

[0007] The above aspect is further shown in the drawings and described in the corresponding description below. Note that the description and the drawings merely illustrate the principles of the present invention. Therefore, although various configurations that embody the principles of the present invention are not explicitly described or illustrated herein, they can be devised from the description and are within the scope thereof.

Brief Description of the Drawings

[0008] The detailed description will be described with reference to the accompanying drawings.

Figure 1

Figure 1A

Figure 2

Figure 2A

Figure 2B

Figure 3

Mode for Carrying Out the Invention

[0009] The present disclosure provides an embodiment of a catheter system for implant delivery, specifically, a catheter for transvascular delivery and deployment of an implant in a living body, such as a human body or an animal body. The catheter includes a distal section, an intermediate section, and a proximal section. The proximal section remains outside the living body and includes a handle that houses a mechanism for controlling movement in the distal section of the catheter. The distal section includes an implant holder, a tip portion, and a capsule assembly. In the loaded state, the capsule assembly houses the implant on a guide wire shaft. The intermediate section is connected to the handle proximally and to the distal section distally.

[0010] The intermediate section is located between the handle and the capsule assembly. The intermediate section comprises a plurality of concentric shafts, and all the shafts are present over at least one-quarter of the full length of the intermediate section. The intermediate section has at least a guide wire shaft, an inner shaft, and a catheter shaft. The guide wire shaft is the innermost shaft and passes concentrically through the inner shaft. The guide wire shaft starts from the proximal most side of the proximal section and proceeds to the distal most side of the distal section. The inner shaft starts from the proximal most side of the proximal section and proceeds to the start of the distal section or to where the capsule starts in a fully advanced state. The inner shaft passes concentrically through the catheter shaft. Thus, over the length of the intermediate section where at least the above three shafts are present, in cross-section, from the center, the order of the shafts is the guide wire shaft, the inner shaft, and the catheter shaft, and all the shafts have a common central point.

[0011] The proximal section comprises a handle having a primary rotation knob and a secondary rotation knob, the secondary rotation knob being connected to a threaded wheel, the threaded wheel being engaged with an eccentric luer. The primary rotation knob is connected to a screw-based mechanism to cause movement in the distal section, specifically to move the capsule which is the distal part of the catheter shaft. The rotational movement of the secondary rotation knob causes movement of the inner shaft in the longitudinal direction, while the guide wire shaft is fixed to the eccentric luer and remains stationary. Both the primary rotation knob and the secondary rotation knob are located within the handle housing. The handle housing is also part of the handle, provides protection to the mechanism causing the movement, and also provides a grip to the user.

[0012] The secondary rotation knob is fixed within the handle housing and cannot move in the longitudinal direction. Also, the secondary rotation knob has a cylindrical structure with internal threads on its inner circumference. By means of these internal threads, the secondary rotation knob is engaged with the threaded wheel. The threaded wheel also has a cylindrical structure with external threads on its outer circumference. The threaded wheel also has a pore at its center. The diameter of the pore is larger than the outer diameter of the inner shaft. The proximal end of the inner shaft is connected to the pore. Thus, when the secondary rotation knob rotates, the threaded wheel moves in the longitudinal direction towards the tip or in the opposite direction depending on the rotation direction of the secondary rotation knob. As described above, the inner shaft is connected to the threaded wheel. Thus, when the threaded wheel moves in the longitudinal direction, the inner shaft moves in the longitudinal direction 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, in the circumferential direction, the width of the groove is variable and, at the upper limit, the width can be made wide enough so that the threaded wheel does not lose its ability to move in the longitudinal direction by the rotational movement of the secondary rotation knob.

[0014] Furthermore, the threaded wheel is engaged 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 is aligned with the center of the threaded wheel. However, the lure arm is attached to the lure such that the longitudinal axis of the lure arm is parallel to the longitudinal axis passing through the centers of the guide wire port and the pore, but is located at a radial distance from the longitudinal axis passing through the center of the pore. The eccentric lure is engaged 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 the threaded wheel moves longitudinally. When assembling the components, the eccentric lure does not move, and the engagement between the lure arm and the groove limits the rotational movement of the threaded wheel. Therefore, when the secondary rotation knob rotates, the threaded wheel moves only longitudinally.

[0015] Furthermore, the guide wire port of the eccentric lure is connected to a guide wire shaft. The guide wire shaft is also hollow and extends from the guide wire port located on the most proximal side of the proximal section to the most distal part of the tip as described above. The hollow guide wire shaft provides an access path for the guide wire during a medical procedure. The guide wire 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 rotation knob. The safety mechanism includes a safety pin and a safety slot, and when engaged, locks the movement of the secondary rotation knob. The safety slot can be designed on the circumferential surface or cross-section of the secondary rotation knob, or the safety slot can also exist as a protrusion on any surface of the secondary rotation knob. The safety pin can be removable from the handle or 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 rotation knob. When the safety pin is inserted into the safety slot, the rotational movement of the secondary rotation knob is restricted, and as a result, the longitudinal movement of the inner shaft is restricted.

[0018] The catheter system for implant delivery according to an embodiment of the present 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 when 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 rotational direction of the primary rotation knob. The distal end of the catheter shaft has a capsule on which the implant is loaded in a compressed form on the guide wire shaft. The backward movement of the catheter shaft causes the backward movement of the capsule, and the capsule releases the implant for deployment. The inner shaft is attached to an implant holder, and the implant holder is engaged with the implant during loading of the implant into the capsule and remains engaged until the backward movement of the capsule releases the implant for deployment. The inner shaft moves within the longitudinal axis when the secondary rotation knob is rotated. The longitudinal movement of the inner shaft causes the 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, valve, mesh, balloon, patch, drug-containing matrix, shunt, or a combination thereof.

[0020] According to yet another embodiment of the present disclosure, the inner shaft is connected to the pores via an adhesive, sealant, glue, thread, welding, or a combination of other mechanical, chemical, or both types of connection 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 pores 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 elements 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] According to yet another embodiment of the present disclosure, the catheter system for implant delivery comprises a display mechanism for indicating the degree of implant delivery during the implant delivery procedure.

[0024] According to yet another embodiment of the present disclosure, the catheter system for implant delivery comprises 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 the body of a human or an animal.

[0025] According to yet another embodiment of the present invention, the implant is used in the treatment of any abnormality associated with the heart, kidney, liver, brain, pancreas, lung, digestive system, intravascular system, any tube, duct, or any conduit in the body of an animal or human, or in any medical procedure. More specifically, the implant can be placed in the arteries, veins, heart valves, esophagus, bile ducts, urinary tract, digestive tract, tracheobronchial tree, cerebral aqueduct, or urogenital system of an animal or human body.

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

[0027] Referring now to the figures, elements are given like numbers throughout several of the figures. Further, reference is made to the accompanying drawings which form a part hereof and which illustrate specific embodiments by way of example 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.

[0028] Refer to FIGS. 1 and 1A according to an embodiment of the present disclosure of a catheter system (100) for implant delivery. The catheter system for implant delivery includes a distal section (400), an intermediate section (300), and a proximal section (200). The proximal end (200) remains outside the body of the living being and includes a handle (110) that includes a mechanism for controlling the movement at the distal end of the catheter within a handle housing (112). The distal end (400) includes a tip (101), a capsule (102) that is the distal portion of the catheter shaft (103), an implant holder (109) connected to the distal end of the inner shaft (104), and a portion of a guide wire shaft (106) in which an implant (not shown) is accommodated.

[0029] The intermediate section (300) is positioned between the handle (110) and the implant holder (109). The intermediate section comprises at least an inner shaft (104), a guide wire shaft (103), and a catheter shaft (106). All the shafts are concentrically arranged, i.e., cross-sectionally centered from the center over the length of the intermediate section at the points where all the shafts are present, and the order of the shafts is the guide wire 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. The rotational movement of the primary rotation knob (116) causes longitudinal movement of the catheter shaft (106) from the implant holder (109) to the tip (101) to load or unload an implant accommodated on a part of the guide wire (103) and between the implant holder (109) and the tip portion (101). Both the primary rotation knob (116) and the secondary rotation knob (118) are located within the handle housing (112).

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

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

[0033] The rotational movement of the secondary rotation knob (118) causes the longitudinal movement of the threaded wheel (120), 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, when the primary rotation knob (116) is rotated, a large movement occurs and the implanted implant is exposed for deployment. The rotation of the secondary rotation knob (118) causes a small movement that further improves the positioning of the implant and ensures the separation of the implant from the implant holder due to the longitudinal movement of the implant holder.

[0035] In addition, the secondary rotation knob (118) includes a safety pin (130) that engages with a safety slot (132) present on the cross-section of the secondary rotation knob (11) to limit unwanted movement of the secondary rotation knob (118).

[0036] 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 drawings are illustrative of exemplary embodiments of the present disclosure and are intended to avoid obscuring the present disclosure.

Description of Reference Numerals

[0037]

Table 1

Claims

1. 1. A percutaneous catheter for delivering an implant, comprising: a primary rotation knob connected to the catheter shaft to facilitate longitudinal movement of the catheter shaft; a secondary rotation knob connected to the inner shaft to facilitate longitudinal movement of the inner shaft, the secondary rotation knob being connected to a threaded wheel that engages the secondary rotation knob via a screw thread; an eccentric luer having a guidewire port connected to a guidewire shaft; at least one luer arm connected to the eccentric luer and spaced radially apart, the at least one luer arm being parallel to the longitudinal axis and passing through the guidewire port and the center of the guidewire shaft; at least a groove cut longitudinally into the threaded wheel and accessible from at least one cross section of the threaded wheel; The luer arm passes through the groove in the threaded wheel, and the threaded wheel moves longitudinally on the luer arm upon rotational movement of the secondary rotation knob.

2. The percutaneous catheter for implant delivery of claim 1 , wherein the threaded wheel comprises a slot connected to the inner shaft.

3. The percutaneous catheter for delivering an implant 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 of claim 1 , wherein an additional element is present between the inner circumference of the guidewire port and the outer circumference of the guidewire shaft.

5. The percutaneous catheter for delivering an implant according to any one of claims 1 to 4, wherein the additional element is connected to the different element 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, non-metals, alloys, polymers, wood, natural fibers, synthetic fibers, or combinations thereof.

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

8. The percutaneous catheter for implant delivery of claim 1 , comprising a safety mechanism that locks the secondary rotation knob from moving.

9. 10. The percutaneous catheter for implant delivery of claim 9, wherein the safety mechanism comprises a safety pin and a safety slot that, when engaged, locks movement of the secondary rotation knob.

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

11. 2. The percutaneous catheter for delivering an implant 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.

12. 10. The percutaneous catheter for implant delivery of claim 1, including an indicator mechanism for indicating the extent of implant delivery.

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

Images