Delivery mechanism of an aneurysm occlusion device

Abstract

The present invention is applicable to the technical field of medical devices, and discloses a delivery mechanism for an aneurysm occlusion device. To achieve the above object, the present invention provides a delivery mechanism for an aneurysm occlusion device, which includes a sheath tube and a catheter movably disposed within the sheath tube; a first wire and a second wire movably disposed within the catheter; the first wire and the second wire can move relative to the catheter independently and pass through the middle hole of the occlusion device; a protrusion is provided at the distal end of the first wire, and the second wire and the protrusion can pass through the middle hole respectively in sequence to limit the occlusion device, and load the occlusion device into the sheath tube. It solves the technical problem that the occlusion device cannot be reloaded after being disconnected from the delivery mechanism.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a delivery mechanism for an aneurysm occlusion device. Background Art

[0002] An intracranial aneurysm refers to a localized bulging and dilation of the arterial wall caused by acquired pathological factors or congenital malformations. The incidence of intracranial aneurysms is extremely high, about 5%. Its course is often relatively hidden, and rupture and bleeding are often sudden, and the fatality or disability rate is also relatively high. The fatality rate of the first rupture and bleeding is 8% - 45%, the fatality rate within one year is higher than 60%, and the fatality rate within two years reaches more than 85%. Therefore, internationally, it is generally emphasized that early diagnosis and treatment of intracranial aneurysms have important clinical significance for improving the survival rate and quality of life of patients. Currently, the common treatment method for cerebral aneurysms is endovascular interventional embolization; mainly, a occlusion device is implanted into the aneurysm through a delivery mechanism to block the aneurysm and achieve the purpose of treatment.

[0003] Chinese Utility Model Patent with Publication No. CN209450597U discloses an occlusion device for intracranial aneurysms. The occlusion device includes an occlusion device body, a visualization marker, a delivery guide wire, a separation point, a delivery tube, and a separator. The visualization markers are respectively fixed at the distal end and the proximal end of the occlusion device body; the occlusion device is woven into a net by 24 - 72 strands of nitinol shape memory alloy wires; after the occlusion device is fully opened, visualization markers are provided at both the distal end and the proximal end, and the visualization markers respectively bundle and fix the nitinol shape memory alloy wires at the distal end and the proximal end of the occlusion device; the delivery guide wire is located inside the delivery tube; a separation point is provided between the visualization marker at the proximal end of the occlusion device and the distal end of the delivery guide wire; the proximal end of the delivery guide wire is connected to the separator. This device disconnects the occlusion device through the separator but cannot be further retrieved, and cannot be further adjusted when the position of the occlusion device is inappropriate or not in place. Summary of the Invention

[0004] The purpose of the present invention is to overcome the above-mentioned deficiencies of the prior art, and provide a delivery mechanism for an aneurysm occlusion device, which limits the device through a first wire drawing and a second wire drawing, aiming to solve the technical problem that the occlusion device cannot be reloaded after being disconnected from the delivery mechanism in the prior art.

[0005] To achieve the above purpose, the present invention provides a delivery mechanism for an aneurysm occlusion device, including a sheath tube and a catheter movably arranged inside the sheath tube; a first wire drawing and a second wire drawing movably arranged inside the catheter; the first wire drawing and the second wire drawing can move relative to the catheter independently and pass through the middle hole of the occlusion device; a convex part is provided at the distal end of the first wire drawing, and the second wire drawing and the convex part can respectively pass through the middle hole successively to limit the occlusion device, and load the occlusion device into the sheath tube.

[0006] Preferably, the sum of the diameter of the largest part of the convex part and the diameter of the second wire drawing is greater than the diameter of the middle hole; the sum of the diameter of the part of the first wire drawing that does not include the convex part and the diameter of the second wire drawing is less than or equal to the diameter of the middle hole.

[0007] Preferably, a handle is connected to the proximal ends of the first wire drawing and the second wire drawing, and a push rod for driving the first wire drawing and the second wire drawing to move is arranged in the handle.

[0008] Preferably, an upper track is arranged in the handle, and an upper push rod for driving the second wire drawing to move is connected to the upper track; a lower track is arranged in the handle, and a lower push rod for driving the first wire drawing to move is connected to the lower track.

[0009] Preferably, the upper track and the lower track are parallel.

[0010] Preferably, an upper spring is connected to the end of the upper push rod far away from the plugging device, and a lower spring is connected to the end of the lower push rod far away from the plugging device; the length of the upper spring is greater than the length of the lower spring.

[0011] Preferably, a dial rod is connected to one side of the upper push rod; when the dial rod moves in the direction away from the plugging device, it can push the lower push rod to move together.

[0012] Preferably, the cross section of the dial rod is in the shape of a right triangle.

[0013] Preferably, a push button is connected to the upper push rod; the push button extends from the upper push rod to the outside of the handle; a track for the movement of the push button is arranged on the handle.

[0014] Preferably, the cross section of the end of the handle close to the plugging device is semi-elliptical.

[0015] Preferably, symmetric push grooves are arranged on the push button.

[0016] Compared with the prior art, the beneficial effects of the delivery mechanism of the aneurysm plugging device provided by the present invention are as follows:

[0017] 1. By arranging a convex part on the first wire drawing and cooperating with the second wire drawing to limit the plugging device, it is convenient to reload the plugging device. And relying on the first wire drawing and the second wire drawing, the structure is simple and the cost is low.

[0018] 2. By arranging a dial rod and a push button on the upper push rod, only by controlling the push button can the movement of the first wire drawing and the second wire drawing be controlled simultaneously.

[0019] 3. By setting the upper spring and the lower spring, the original states of the first wire drawing and the second wire drawing can be better controlled, which is convenient for loading the plugging device.

[0020] The features and advantages of the present invention will be described in detail through embodiments in conjunction with the accompanying drawings. Description of the Drawings

[0021] Figure 1 It is an enlarged structural schematic diagram without a handle of the delivery mechanism of an aneurysm plugging device according to an embodiment of the present invention.

[0022] Figure 2 It is a structural schematic diagram of the loading state of the delivery mechanism of an aneurysm plugging device according to an embodiment of the present invention.

[0023] Figure 3 It is an enlarged structural schematic diagram at position A of the delivery mechanism of an aneurysm plugging device according to an embodiment of the present invention.

[0024] Figure 4 It is a structural schematic diagram of the limiting state of the delivery mechanism of an aneurysm plugging device according to an embodiment of the present invention.

[0025] Figure 5 It is an enlarged structural schematic diagram at position B of the delivery mechanism of an aneurysm plugging device according to an embodiment of the present invention.

[0026] Figure 6 It is a structural schematic diagram of the intermediate state of release of the delivery mechanism of an aneurysm plugging device according to an embodiment of the present invention.

[0027] Figure 7 It is an enlarged structural schematic diagram at position C of the delivery mechanism of an aneurysm plugging device according to an embodiment of the present invention.

[0028] Figure 8 It is a structural schematic diagram of the complete state of release of the delivery mechanism of an aneurysm plugging device according to an embodiment of the present invention.

[0029] In the figure: 1. Plugging device; 31. First wire drawing; 311. Protruding part; 32. Second wire drawing; 33. Catheter; 34. Sheath; 35. Handle; 351. Push button; 352. Upper push rod; 353. Upper spring; 354. Lever; 355. Lower push rod; 356. Lower spring; 357. Upper track; 358. Lower track; 359. Push groove. Detailed Embodiments

[0030] To make the objectives, technical solutions and advantages of the present invention clearer, the present utility model will be further described in detail below with reference to the accompanying drawings and embodiments. However, it should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the scope of the present invention. In addition, in the following description, descriptions of well-known structures and technologies are omitted to avoid unnecessarily obscuring the concepts of the present invention.

[0031] In the description of the present invention, it should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it can be directly on the other element or indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or indirectly connected to the other element.

[0032] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "center", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the inventive product is customarily placed during use. It is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the present invention. In addition, the terms "first", "second", "third", etc. are only used for descriptive distinction and should not be construed as indicating or implying relative importance. Thus, features defined with "first" and "second" may explicitly or implicitly include one or more of such features. In the description of the present invention, "a plurality" means two or more unless otherwise specifically defined. "Several" means one or more unless otherwise specifically defined.

[0033] In the description of the present invention, it should also be noted that unless otherwise clearly defined and limited, the terms "set", "installed", "connected", "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0034] Reference will now be made in detail to embodiments of the present disclosure. As used herein, the term "clinician" refers to a doctor, surgeon, nurse, or any other care provider, and may include ancillary personnel. The term "proximal" will refer to the portion of the device or its component that is closer to the clinician, and the term "distal" will refer to the portion of the device or its component that is farther from the clinician.

[0035] The occlusion device 1 employed in the present invention further has a middle hole for the first wire 31 and the second wire 32 to pass through. As long as the same function as that of the present invention is achieved by the cooperation of the first wire 31 and the second wire 32 with the middle hole for limiting, it should be understood that it falls within the protection scope of the present invention.

[0036] Specifically, the occlusion device 1 employed in the present invention includes a mesh elastic outer shell, a proximal convergence portion formed by the proximal end of the mesh elastic outer shell converging inward, and a distal convergence portion formed by the distal end of the mesh elastic outer shell converging inward. The proximal convergence portion and the distal convergence portion converge at the middle marking portion and are connected to the middle marking portion. The middle marking portion is provided with a middle hole. The occlusion device fits the aneurysm cavity for occlusion. The occlusion device 1 includes a self-expanding form and a delivery form, and the outer diameter of the self-expanding form is larger than that of the delivery form. In the self-expanding form, the diameter of the mesh elastic outer shell is larger than the maximum diameter of the aneurysm cavity, and the outer diameter of the delivery form is smaller, facilitating the delivery of the occlusion device.

[0037] Embodiment 1:

[0038] Refer to Figure 1 、 Figure 2 and Figure 3, an embodiment of the present invention provides a delivery mechanism for an aneurysm occlusion device, including a sheath 34 and a catheter 33 movably disposed within the sheath 34. A first wire 31 and a second wire 32 are movably disposed within the catheter 33. The first wire 31 and the second wire 32 can move independently relative to the catheter 33 and pass through the middle hole of the occlusion device 1. A convex portion 311 is provided at the distal end of the first wire 31. The second wire 32 and the convex portion 311 can respectively pass through the middle hole successively to limit the occlusion device 1, and load the occlusion device 1 into the sheath 34. After the convex portion 311 of the first wire 31 passes through the middle hole, the second wire 32 also passes through the middle hole, and the convex portion 311 cooperates with the second wire 32 to resist the middle hole. When the clinician withdraws the first wire 31 and the second wire 32 proximally, the occlusion device 1 is driven to withdraw together and enter the sheath. Here, the sheath is just a general term, and as long as it can be used to load the occlusion device 1, it belongs to the protection scope of the present invention. The first wire 31 and the second wire 32 are axially flexible filaments, and the catheter 33 is an axially flexible tubular body. The first wire 31, the second wire 32, the catheter 33, and the convex portion 311 can be made of memory metal, polymer, and other materials. The catheter 33 cannot pass through the middle hole, and a limit can be formed proximally, so that the occlusion device 1 can smoothly enter the aneurysm.

[0039] Refer to Figure 2 , in an optional embodiment, the sum of the diameter of the largest part of the convex portion 311 and the diameter of the second wire 32 is greater than the diameter of the middle hole. The sum of the diameter of the part of the first wire 31 that does not include the convex portion 311 and the diameter of the second wire 32 is less than or equal to the diameter of the middle hole. With such a setting, the structure is simple, so that the first wire 31 and the second wire 32 can enter and exit the middle hole independently without obstruction, and it is more convenient to use.

[0040] Medical staff can directly control the connection state between the first wire 31 and the second wire 32 and the occlusion device 1 to realize the release and loading of the occlusion device 1.

[0041] Embodiment Two:

[0042] To facilitate the control of the first wire 31 and the second wire 32, the solution of Embodiment One is improved. The specific improvement scheme is as follows:

[0043] Refer to Figure 2, in an alternative embodiment, a handle 35 is connected to the proximal ends of the first wire 31 and the second wire 32, and a push rod for driving the first wire 31 and the second wire 32 to move is provided inside the handle 35. By arranging the proximal ends of the first wire 31 and the second wire 32 inside the handle 35, the proximal wires will not be too messy or even entangled with each other, which affects the use. It is more convenient to control the first wire 31 and the second wire 32 by using a push rod, overcoming the problem that it is inconvenient to operate due to the too thin wire, and the effect is better in the actual use process.

[0044] Further, referring to Figure 2 , in an alternative embodiment, an upper track 357 is provided inside the handle 35, and an upper push rod 352 for driving the second wire 32 to move is connected to the upper track 357. A lower track 358 is provided inside the handle 35, and a lower push rod 355 for driving the first wire 31 to move is connected to the lower track 358. The upper track 357 and the lower track 358 are parallel, which is more in line with the operation habits of medical staff and is also simpler to use. By providing the upper track 357 and the lower track 358, it is more convenient during the use process, and the wires can run in specific tracks to prevent the wires from being entangled with each other.

[0045] Embodiment Three:

[0046] Since it is impossible to clearly observe the positions of the first wire 31 and the second wire 32 relative to each other after their distal ends enter the human artery. However, during the actual loading process, the protruding portion 311 of the first wire 31 must first pass through the middle hole of the occlusion device 1, and then the second wire 32 can pass through the middle hole for limiting. Therefore, the solution of Embodiment Two is further optimized.

[0047] Referring to Figure 2 , in an alternative embodiment, an upper spring 353 is connected to the end of the upper push rod 352 away from the occlusion device 1, and a lower spring 356 is connected to the end of the lower push rod 355 away from the occlusion device 1. The length of the upper spring 353 is greater than the length of the lower spring 356. Here, the length means that when the upper spring 353 and the lower spring 356 are both in the natural condition (i.e., not under the external force control of medical staff), the distal end of the upper spring 353 is farther away from the medical staff relative to the distal end of the lower spring 356. Preferably, the elastic potential energies of the two springs are the same and the fixed positions of the proximal ends are at the same distance from the medical staff.

[0048] Embodiment Four:

[0049] Controlling the first wire 31 and the second wire 32 separately is too troublesome. In order to simplify the operation process, the technical solution is further optimized on the basis of Embodiment Three.

[0050] Referring to Figure 2, in an optional embodiment, a lever 354 is connected to one side of the upper push rod 352. When the lever 354 moves away from the occlusion device 1, it can push the lower push rod 355 to move together. Medical staff only need to control the upper push rod 352 to control the lower push rod 355, which is more simple to operate, can be operated with one hand, and also improves the degree of automation.

[0051] Refer to Figure 2 , in an optional embodiment, the cross-section of the lever 354 is a right triangle. The upper push rod 352 is detachably installed on the upper track 357. When the right-angled side and the hypotenuse face the lower push rod 355, the adjustment stroke is different, and the adjustment stroke is more convenient.

[0052] Refer to Figure 2 , in an optional embodiment, a push button 351 is connected to the upper push rod 352. The push button 351 extends from the upper push rod 352 to the outside of the handle 35, which is more convenient and labor-saving to operate, and there is no need to directly push the upper push rod 352. A track for the movement of the push button 351 is provided on the handle 35.

[0053] Refer to Figure 2 , in an optional embodiment, the cross-section of one end of the handle 35 close to the occlusion device 1 is semi-elliptical, gradually narrowing from the proximal end to the distal end, and two openings are provided at the farthest end for two wire draws to pass through. Such a setting can enable the two wire draws to better enter the catheter 33 and be parallel in the catheter 33.

[0054] Refer to Figure 2 , in an optional embodiment, symmetric push grooves 359 are provided on the push button 351. The fingers of medical staff can press on the grooves 359 to push, which is not easy to slip off, and can better control the force, preventing the horizontal push and pull from being too easy, resulting in too fast push and pull of the wire draw movement and causing damage to the artery.

[0055] During interventional treatment of the delivery mechanism and the occlusion device, first, the position of the aneurysm is passed through angiography, and the catheter in the sheath 34 (at this time, the sheath has been loaded with the occlusion device, as Figure 2 shown) is pushed into the microcatheter. It enters the aneurysm along the inner cavity of the microcatheter. After the occlusion device 1 is released from the constraint of the microcatheter, it slowly unfolds in the aneurysm and gradually expands to adapt to the state of the aneurysm. The position is observed through the imaging marker of the occlusion device to see if it is appropriate.

[0056] If the position is appropriate, the plugging device 1 is released, and the specific release process is as follows. When the release of the plugging device 1 has not started, at this time, the upper push rod 352 and the lower push rod 355 are only kept on their respective tracks under the action of the spring. In this state, the second wire 32 and the first wire 31 both pass through the middle hole, and the farthest end of the second wire 32 is farther from the handle 35 relative to the convex portion 311. The convex portion 311 and the second wire 32 cannot pass through the middle hole simultaneously (as Figure 4 , Figure 5 shown).

[0057] Then, slowly push the push button 351 proximally. The upper push rod 352 slowly compresses the upper spring 353, and the second wire 32 also moves proximally with the upper push rod 352 and passes out of the middle hole (as Figure 6 , Figure 7 shown). At this time, the lever 354 can just touch the lower push rod 355 or still needs to move a certain distance to touch the lower push rod 355. Continue to push the push button 351 proximally. The lever 354 drives the lower push rod 355 to move proximally, and the lower spring 356 is compressed. The convex portion 311 of the first wire 31 also slowly passes out of the middle hole. At this time, both the first wire 31 and the second wire 32 enter the catheter 33, and this is the process of complete release of the plugging device (as Figure 8 shown).

[0058] If the plugging device 1 is not appropriate or the release position is incorrect, reloading is performed. Align the catheter 33 of the handle 35 in the Figure 8 state with the middle hole. Slowly release the push button 351, and the first wire 31 and the second wire 32 move distally simultaneously. However, the convex portion 311 of the first wire 31 is closer to the middle hole relative to the distal end of the second wire 32. Therefore, the convex portion 311 of the first wire 31 passes through the middle hole first, and at this time, the second wire 32 is about to pass through the middle hole. Continue to release the push button 351. After the convex portion 311 moves forward a certain distance, the lever 354 separates from the lower push rod 355. Continue to release the push button 351, the first wire 31 does not move, and the second wire 32 passes through the middle hole. During the process of withdrawing the handle 35, the convex portion 311 cooperates with the second wire 32 for limiting, and they cannot pass through the middle hole simultaneously. The plugging device 1 is withdrawn together with the handle 35, and the plugging device 1 is compressed and loaded into the microcatheter (as Figure 2 shown).

[0059] The above are only the preferred embodiments of the present invention and are not used to limit the present invention. Any modifications, equivalent replacements, or improvements made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A delivery mechanism for an aneurysm occlusion device, comprising a sheath tube (34) and a catheter (33) movably disposed within the sheath tube (34); characterized in that: A first wire (31) and a second wire (32) movably arranged in the catheter (33); the first wire (31) and the second wire (32) can move relative to the catheter (33) separately and pass through the middle hole of the occlusion device (1); a convex portion (311) is provided at the distal end of the first wire (31). After the convex portion (311) of the first wire (31) passes through the middle hole, the second wire (32) also passes through the middle hole. The convex portion (311) cooperates with the second wire (32) to abut against the middle hole. The convex portion (311) and the second wire (32) can pass through the middle hole respectively and successively to limit the occlusion device (1), and load the occlusion device (1) into the sheath (34); an upper track (357) is provided in the handle (35), and an upper push rod (352) for driving the second wire (32) to move is connected to the upper track (357); a lower track (358) is provided in the handle (35), and a lower push rod (355) for driving the first wire (31) to move is connected to the lower track (358); the upper track (357) and the lower track (358) are parallel; an upper spring (353) is connected to the end of the upper push rod (352) away from the occlusion device (1), and a lower spring (356) is connected to the end of the lower push rod (355) away from the occlusion device (1); under natural conditions, the length of the upper spring (353) is greater than the length of the lower spring (356); a lever (354) is connected to one side of the upper push rod (352); when the lever (354) moves from the farthest end towards the direction away from the occlusion device (1), it first drives the second wire (32) to move proximally, and then can push the lower push rod (355) to drive the first wire (31) to move proximally.

2. The delivery mechanism of the aneurysm occlusion device according to claim 1, characterized in that: The sum of the maximum diameter of the convex portion (311) and the diameter of the second wire (32) is greater than the diameter of the middle hole; the sum of the diameter of the portion of the first wire (31) excluding the convex portion (311) and the diameter of the second wire (32) is less than or equal to the diameter of the middle hole.

3. The delivery mechanism of the aneurysm occlusion device according to claim 1, characterized in that: A push button (351) is connected to the upper push rod (352); the push button (351) extends from the upper push rod (352) to the outside of the handle (35); a track for the movement of the push button (351) is provided on the handle (35).

4. The delivery mechanism of the aneurysm occlusion device according to claim 1, characterized in that: The cross-section of the end of the handle (35) close to the occlusion device (1) is semi-elliptical.

5. The delivery mechanism of the aneurysm occlusion device according to claim 3, characterized in that: Push grooves (359) symmetrically arranged left and right are provided on the push button (351).

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