A vascular embolization treatment device

Abstract

This invention provides a vascular embolization treatment device, relating to the field of vascular embolization medical device technology. It includes a delivery tube and a spring coil. The spring coil includes a spring coil body and an end fixed to the distal end of the spring coil body. It also includes an end control mechanism and a spring coil control mechanism, with the distal end of the end control mechanism detachably connected to the proximal end of the end. The distal end of the delivery tube is detachably connected to the proximal end of the spring coil body via the spring coil control mechanism. This invention can improve the success rate of spring coil formation, avoid mis-embolization, and reduce surgical risks.

Description

Technical Field

[0001] This invention relates to the field of medical device technology for vascular embolization, and more particularly to a vascular embolization treatment device. Background Technology

[0002] Percutaneous transcatheter embolization (PTE) is a clinical treatment method that uses embolic materials to block abnormal blood vessels. Coils are the most commonly used mechanical embolization material, and their delivery and release methods are divided into push-type and detachable type. Most existing detachable coil delivery systems adopt a single control pathway design: the delivery system is connected to the proximal end of the coil to achieve the pushing function; the distal end of the coil has no independent control structure and relies entirely on hemodynamics and the physician's operational experience for positioning.

[0003] The existing conveying system has at least the following disadvantages: Prone to tip displacement: Existing technology only controls the proximal end of the coil through a single control mechanism. After the tip enters the blood vessel, there is a lack of active restraint, resulting in a situation where "the proximal end is controllable, but the distal end is out of control". It is prone to "drifting" or unexpected deformation of the coil due to blood flow impact, leading to molding failure, increased surgical risk, and the surgical outcome is highly dependent on the doctor's experience.

[0004] Once released, it cannot be withdrawn: In existing technologies, the release is triggered once the coil extends out of the microcatheter from the release area. Once released, it cannot be withdrawn or adjusted, which can easily lead to misembolization or require additional surgery to remove it.

[0005] Therefore, a device is needed to solve the above-mentioned technical problems. Summary of the Invention

[0006] The purpose of this invention is to provide a vascular embolization treatment device to solve the problems existing in the prior art, improve the success rate of coil molding, avoid the problem of misembolization, and reduce surgical risks.

[0007] To achieve the above objectives, the present invention provides the following solution: A vascular embolization treatment device includes a delivery tube and a spring coil. The spring coil includes a spring coil body and an end fixed at the distal end of the spring coil body. It also includes an end control mechanism and a spring coil control mechanism, the distal end of which is detachably connected to the proximal end of the end. The distal end of the delivery tube is detachably connected to the proximal end of the spring coil body through the spring coil control mechanism.

[0008] As one embodiment, the end control mechanism includes an end control wire, the distal end of which is connected to the end via a first connecting mechanism capable of producing a disconnection or connection action; and / or, the distal end of the end control wire is connected to the end via a connecting material capable of melting or hydrolysis.

[0009] In one embodiment, the first connecting mechanism includes an external threaded end and an internal threaded hole, wherein the external threaded end is located near the end of the end or far from the end control wire, and the internal threaded hole is located far from the end control wire or near the end.

[0010] As one embodiment, at least a portion of the end control wire is located inside the spring coil body, and the distal end of the portion of the end control wire located inside the spring coil body is connected to the end.

[0011] In one embodiment, the spring coil control mechanism includes a first locking part, a second locking part, and a spring coil control wire. The first locking part is fixed to the distal end of the delivery pipe and has a first operating hole parallel to the axial direction of the delivery pipe. The second locking part is fixed to the proximal end of the spring coil body and engages with the first locking part to achieve axial limiting. The second locking part has a second operating hole parallel to or directly opposite the first operating hole. The spring coil control wire passes through the first operating hole and the second operating hole in sequence to achieve radial limiting of the first locking part and the second locking part.

[0012] In one embodiment, the first snap-fit ​​portion has a groove along the direction from the proximal end to the distal end, and the second snap-fit ​​portion has a protrusion, which is slidably disposed in the groove. The surface of the groove that fits with the protrusion is a guide surface that facilitates the sliding disengagement of the protrusion.

[0013] As one embodiment, a through hole is provided on the side wall of the conveying pipe, and the end control wire passes through the through hole into the conveying pipe.

[0014] In one embodiment, the delivery pipe has at least two cavities, and the end control wire and the spring coil control wire are respectively disposed in the cavity.

[0015] In one embodiment, the proximal end of the spring coil control wire is fixedly connected to the delivery tube, and the wall of the delivery tube has a breakable portion that facilitates its breakage. The breakable portion is located on the distal side of the fixed position between the spring coil control wire and the delivery tube.

[0016] As one embodiment, the easily breakable part is a groove provided on the wall of the conveying pipe; a length mark is provided on the outer wall of the conveying pipe.

[0017] Compared with the prior art, the present invention has the following technical effects: This invention, by incorporating an end-cap control mechanism connected to the end of the coil, actively positions the end to resist blood flow impact. This prevents the end from swinging due to blood flow impact or the coil body from stretching distally upon impact, thus avoiding problems such as difficulty in shaping the coil body according to the set pattern. This significantly improves the success rate of coil body shaping and reduces surgical risks. Furthermore, in this invention, the delivery tube is detachably connected to the coil body via the coil control mechanism. While connected, the coil body can be adjusted and retracted through the delivery tube to prevent mis-implantation and reduce the likelihood of needing a second surgery. After disconnection, the coil can be properly released.

[0018] Compared with the prior art, other technical solutions in this invention have the following technical effects: In this invention, when the end control wire and the ends are connected by an electrically fusible material, the complexity of the detachable connection mechanism can be significantly reduced, thereby simplifying the structure and facilitating surgical operations. Attached Figure Description

[0019] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1 This is a schematic diagram illustrating the principle of electrolytic melting of the end control wire in a vascular embolization treatment device according to one embodiment of the present invention. Figure 2 This is a schematic diagram of the structure of a vascular embolization treatment device according to one embodiment of the present invention; Figure 3 This is a schematic diagram of the distal end of the vascular embolization treatment device in one embodiment of the present invention (the end control wire is not U-shaped). Figure 4 This is a schematic diagram of the distal end of the vascular embolization treatment device in one embodiment of the present invention (the end control wire is U-shaped). Figure 5 This is a schematic diagram of the proximal end of the vascular embolization treatment device in one embodiment of the present invention (the end control wire is not U-shaped). Figure 6 This is a schematic diagram of the distal end of the vascular embolization treatment device in one embodiment of the present invention (the end control wire is U-shaped). Figure 7 This is a schematic diagram of a structure with a through hole on the conveying pipe in one embodiment of the present invention; Figure 8This is a schematic diagram of a conveying pipe with a groove in one embodiment of the present invention (the notch in the conveying pipe at the location of reference numerals 3 and 4 in this figure is only partially cut to show its internal structure, and does not mean that a notch must be set at this location). Figure 9 This is a schematic diagram of a threaded structure at the distal end of the end control wire in one embodiment of the present invention.

[0021] Figure label: 1. End; 2. Spring coil body; 21. Second snap-fit ​​part; 3. End control wire; 4. Spring coil control wire; 5. Conveyor pipe; 51. Through hole; 52. Score groove; 53. First snap-fit ​​part. Detailed Implementation

[0022] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0023] The purpose of this invention is to provide a vascular embolization treatment device to solve the problems existing in the prior art, improve the success rate of coil molding, avoid the problem of misembolization, and reduce surgical risks.

[0024] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0025] like Figures 1-9 As shown, this embodiment provides a vascular embolization treatment device, including a delivery tube 5 and a spring coil. The spring coil includes a spring coil body 2 and an end 1 fixed to the distal end of the spring coil body 2. The distal end of the end 1 has a guide structure that can guide the insertion process of the spring coil and reduce insertion resistance. The vascular embolization treatment device also includes an end control mechanism and a spring coil control mechanism. The distal end of the end control mechanism is detachably connected to the proximal end of the end. The distal end of the delivery tube 5 is detachably connected to the proximal end of the spring coil body 2 through the spring coil control mechanism.

[0026] In this embodiment, "distal" refers to the end closer to the patient, and "proximal" refers to the end closer to the surgeon, that is, the end farther from the patient.

[0027] In use, the spring coil is placed into the lesion site via the catheter under the delivery tube 5. The end control mechanism keeps the end 1 stationary, guiding the spring coil body 2 to unfold according to the pre-formed shape. The position and forming state of the spring coil body 2 are confirmed by imaging equipment. If adjustment is needed, the spring coil body 2 is retracted through the delivery tube 5, or the angle of the end 1 is finely adjusted through the end control mechanism until the forming state of the spring coil body 2 meets the requirements. Finally, the distal end of the end control mechanism is disconnected from the end 1, and the connection between the delivery tube 5 and the spring coil body 2 is released. The end control mechanism, delivery tube 5, catheter, etc., are then removed from the body.

[0028] Therefore, this embodiment, by setting an end control mechanism connected to the end 1 of the spring coil, can actively position the end 1 to resist blood flow impact, avoiding the problem of the end 1 swinging due to blood flow impact or the spring coil body 2 being stretched distally when impacted, thus preventing the spring coil body 2 from being difficult to form according to the set method. This can significantly improve the success rate of spring coil body 2 formation and reduce surgical risks. In addition, in this embodiment, the delivery tube 5 is detachably connected to the spring coil body 2 through the spring coil control mechanism. When connected, the spring coil body 2 can be adjusted back through the delivery tube 5 to avoid mis-embolization and reduce the possibility of needing a second surgery; after the connection is broken, the spring coil can be released normally.

[0029] The end control mechanism in this embodiment includes an end control wire 3. The distal end of the end control wire 3 is connected to the end 1 through a first connecting mechanism capable of disconnection and connection, and / or through a connecting material capable of melting or hydrolysis. That is, the end control wire 3 and the end 1 can be mechanically connected by the first connecting mechanism, connected by a connecting material, or connected by both methods simultaneously.

[0030] The proximal end of the end control wire 3 can be connected to the first control mechanism. The surgeon can manually control the end tip 1 through the end control wire 3, or control the end tip 1 through the end control wire 3 via the first control mechanism, to change the force exerted by the end control wire 3 on the end tip 1 (mainly a traction force towards the proximal end or a thrust force towards the distal end). The end control wire 3 usually needs to apply a certain traction force (e.g., 0.5N-1N) to overcome blood flow impact and keep the end tip 1 in place; the delivery tube 5 is continuously pushed, and the traction force is adjusted according to the damping feedback of the first control mechanism (the traction force increases to 2N-3N when the blood flow impact is large).

[0031] The first control mechanism can be a mechanism that pulls and maintains the traction force of the traction wire or guide wire in other medical devices, which is well known to those skilled in the art. Therefore, the detailed structure of the first control mechanism will not be described in this embodiment.

[0032] In this embodiment, the end control wire 3 is made of nickel-titanium alloy with a diameter of 0.01mm-0.03mm and a tensile strength of ≥800MPa. Its surface is coated with titanium nitride to enhance lubricity.

[0033] In this embodiment, the first connecting mechanism includes an external thread structure and an internal thread hole. When the external thread structure is located on the near end face of the end head 1, the internal thread hole is located on the far end face of the end head control wire 3; when the external thread structure is located on the far end face of the end head control wire 3, the internal thread hole is located on the near end face of the end head 1. Thus, the detachable connection between the port control wire and the end head 1 is achieved through threaded engagement.

[0034] When the end control wire 3 and the end 1 are connected using a fusible connecting material, the connecting material used is preferably a low melting point alloy, which requires a smaller current to fuse. Specifically, the connecting material can be a tin-bismuth alloy or a tin-silver-copper alloy.

[0035] When the end control wire 3 and end 1 are connected using a hydrolyzable connecting material, the connecting material can be polylactic acid-glycolic acid copolymer (PLGA). However, when designing the connection structure using a hydrolyzable connecting material, both hydrolytic capability and connection strength must be considered to meet the general adjustment time of end 1.

[0036] In this embodiment, at least a portion of the end control wire 3 is located inside the spring coil body 2, and the distal end of the portion of the end control wire 3 located inside the spring coil body 2 is connected to the end 1.

[0037] In this embodiment, the spring coil control mechanism includes a first locking part 53, a second locking part 21, and a spring coil control wire 4. The first locking part 53 is fixed to the distal end of the delivery pipe 5 and has a first operating hole parallel to the axial direction of the delivery pipe 5. The second locking part 21 is fixed to the proximal end of the spring coil body 2 and engages with the first locking part 53 to achieve axial limiting. The second locking part 21 has a second operating hole parallel to or directly opposite the first operating hole. The proximal end of the spring coil control wire 4 is exposed to the human body, and the distal end passes through the first operating hole and the second operating hole in sequence to achieve radial limiting of the first locking part 53 and the second locking part 21.

[0038] Under the radial limiting action of the spring coil control wire 4, the first locking part 53 and the second locking part 21 cannot be disconnected. Only when the spring coil control wire 4 is pulled out can the first locking part 53 and the second locking part 21 be disengaged, and the spring coil can be released.

[0039] In this embodiment, the spring coil control wire is made of medical-grade 316L stainless steel with a diameter of 0.03mm-0.05mm.

[0040] In this embodiment, the first engaging portion 53 has a groove along the direction from the proximal end to the distal end, and the second engaging portion 21 has a protrusion. The protrusion is slidably disposed in the groove, and the surface of the groove and the protrusion that mates is a guide surface that facilitates the sliding disengagement of the protrusion. Specifically, the guide surface can be an inclined plane or an arc surface.

[0041] In this embodiment, at least a portion of the spring coil control wire 4 is located inside the spring coil body 2, and the distal end of the portion of the spring coil control wire 4 located inside the spring coil body 2 is connected to the spring coil body 2.

[0042] like Figure 4 As shown, in this embodiment, the end control wire 3 can be arranged in a U-shape, with both ends of the U-shape located near the proximal end and connected to end 1 near the bend of the U-shape. End 1 remains at the distal end of the end control wire 3. In this structure, the bend of the U-shape is connected to end 1 using a material that facilitates melting. After the end control wire 3 is disconnected from end 1, either end of the end control wire 3 can be pulled out.

[0043] As an example, such as Figure 7 As shown, in this embodiment, a through hole 51 is provided on the side wall of the delivery tube 5. This through hole 51 can be a strip-shaped hole. The end control wire 3 passes through the through hole 51 into the delivery tube 5, so that part of the end control wire 3 is located inside the delivery tube 5 and the other part is located outside the delivery tube 5. The proximal end of the part located outside the delivery tube 5 is used to apply force to the end control wire 3. During the operation, after the distal end of the end control wire 3 is disconnected from the end 1, the end control wire 3 can be withdrawn from the human body through the through hole 51.

[0044] As another example, such as Figure 5 As shown, in this embodiment, the conveying pipe 5 has at least two cavities, with the end control wire 3 and the spring coil control wire 4 respectively disposed in different cavities to avoid mutual interference between them. In this structural form, the conveying pipe 5 may or may not have a through hole 51 on its side wall, or it may have a through hole 51 communicating with one of the cavities.

[0045] Furthermore, when the end control wire 3 is arranged in a U-shape, the delivery pipe 5 can have at least three lumens, such as... Figure 6 As shown, two cavities are used to accommodate the two straight U-shaped sections of the end control wire 3, and the other cavity is used to accommodate the spring coil control wire 4.

[0046] In this embodiment, the proximal end of the spring coil control wire 4 is fixedly connected to the delivery tube 5. This connection can be achieved through bonding or other methods. The delivery tube 5 has a breakable portion on its wall, located distal to the fixed position of the spring coil control wire 4 and the delivery tube 5, but still outside the body, allowing the surgeon to manually break it. With this structure, when the distal end of the spring coil control wire 4 is not disconnected, the spring coil control wire 4 and the delivery tube 5 are integrated. The spring coil can be delivered by pushing the delivery tube 5, or if the spring coil release position is found to be unsuitable, the delivery tube 5 can be retracted to remove the spring coil, making the retraction operation convenient. After the distal end of the spring coil control wire 4 is disconnected, the delivery tube 5 can be broken from the easily broken part. Then, the proximal part of the easily broken part, along with the spring coil control wire 4, is withdrawn from the body. The first locking part 53 and the second locking part 21 have no radial limit setting, so the spring coil can be released. After the spring coil is completely released, the distal part of the easily broken part in the delivery tube 5 can be withdrawn from the body.

[0047] In this embodiment, the easily broken part is the groove 52 provided on the wall of the delivery pipe 5.

[0048] In this embodiment, a length mark is provided on the outer wall of the conveying pipe 5 to facilitate observation of the conveying length of the conveying pipe 5.

[0049] Any adaptive changes made according to actual needs are within the scope of protection of this invention.

[0050] Specific examples have been used to illustrate the principles and implementation methods of this invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this invention. Furthermore, those skilled in the art will recognize that, based on the ideas of this invention, there will be changes in the specific implementation methods and application scope. Therefore, the content of this specification should not be construed as a limitation of this invention.

Claims

1. A vascular embolization treatment device, comprising: delivery pipe; A spring coil, comprising a spring coil body and an end fixed at the distal end of the spring coil body; characterized in that it further comprises: An end control mechanism, wherein the distal end of the end control mechanism is detachably connected to the proximal end of the end, so as to control the position of the end through the end control mechanism; A spring coil control mechanism is provided, wherein the distal end of the delivery pipe is detachably connected to the proximal end of the spring coil body via the spring coil control mechanism.

2. The vascular embolization treatment device according to claim 1, characterized in that, The end control mechanism includes an end control wire, the distal end of which is connected to the end via a first connection mechanism capable of producing a disconnection or connection action. And / or, The distal end of the end control wire is connected to the end via a connecting material that can be melted or hydrolyzed.

3. The vascular embolization treatment device according to claim 2, characterized in that, The first connecting mechanism includes an external threaded end and an internal threaded hole. The external threaded end is located near the end of the end or far from the end control wire, and the internal threaded hole is located far from the end control wire or near the end.

4. The vascular embolization treatment device according to claim 2, characterized in that, At least a portion of the end control wire is located inside the spring coil body, and the distal end of the portion of the end control wire located inside the spring coil body is connected to the end.

5. The vascular embolization treatment device according to claim 2, characterized in that, The spring coil control mechanism includes: A first latching part is fixed to the distal end of the conveying pipe, and the first latching part has a first operating hole parallel to the axial direction of the conveying pipe. The second snap-fit ​​part is fixed to the proximal end of the spring coil body and snaps into the first snap-fit ​​part to achieve axial limiting; the second snap-fit ​​part has a second operating hole that is parallel to or directly opposite the first operating hole. And a spring coil control wire, which passes through the first operating hole and the second operating hole in sequence to achieve radial limiting of the first locking part and the second locking part.

6. The vascular embolization treatment device according to claim 5, characterized in that, The first snap-fit ​​portion has a groove along the direction from the proximal end to the distal end, and the second snap-fit ​​portion has a protrusion, which is slidably disposed in the groove. The surface of the groove that fits with the protrusion is a guide surface that facilitates the sliding disengagement of the protrusion.

7. The vascular embolization treatment device according to claim 5, characterized in that, The side wall of the conveying pipe is provided with a through hole, and the end control wire passes through the through hole into the conveying pipe.

8. The vascular embolization treatment device according to claim 7, characterized in that, The delivery pipe has at least two cavities, and the end control wire and the spring coil control wire are respectively disposed in the cavities.

9. The vascular embolization treatment device according to claim 7, characterized in that, The proximal end of the spring coil control wire is fixedly connected to the delivery tube, and the wall of the delivery tube has a breakable portion that facilitates its breakage. The breakable portion is located on the distal side of the fixed position between the spring coil control wire and the delivery tube.

10. The vascular embolization treatment device according to claim 9, characterized in that, The easily breakable part is a groove provided on the wall of the delivery pipe; the outer wall of the delivery pipe is provided with a length mark.

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