A mechanical release spring coil system and its manufacturing method and use method

Abstract

The invention discloses a mechanical spring coil release system and a manufacturing method and a use method thereof, which belong to the technical field of medical devices, and comprises a loading tube; an inner push rod, which is slidably connected in the loading tube; a claw, which is arranged at the distal end of the inner push rod, and the inner push rod can selectively slide toward its distal end; and a spring coil, wherein a limiting body is arranged at the proximal end of the spring coil, and can be detachably installed in the claw. The movement of the claw inside and outside the loading tube is realized by the cooperation between the loading tube and the inner push rod, and when the claw is in the loading tube, the limiting body is held inside the loading tube; when the spring coil enters the lesion site, a thrust is manually given to the inner push rod, and at this time, the claw connected to the inner push rod will be pushed out of the loading tube, and the claw is released and opened outside the loading tube, and the limiting body of the spring coil loses its constraint and escapes from the inside, which can not only make the spring coil release more efficient, but also reduce the risk of connection point locking caused by loose connection point and spring coil displacement caused by limiting wire.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a mechanical release coil system and a manufacturing method and a use method thereof. Background Art

[0002] Arteries throughout the body may form aneurysms. Once an aneurysm ruptures, the mortality and disability rates are very high. Especially for aneurysms that occur within the skull, once an intracranial aneurysm ruptures, the patient may die suddenly due to cerebral hemorrhage or develop serious complications. At present, the main treatment for intracranial aneurysms is coil embolization; the general process of coil embolization is: insert a microcatheter into the aneurysm cavity, and then use a push rod to deliver the coil to the aneurysm cavity through the microcatheter. When the shape of the coil is stable in the aneurysm cavity, release the connection between the push rod and the coil to achieve the release of the coil. After the embolization is completed, the aneurysm cavity is filled with coils, which greatly reduces the chance of aneurysm rupture due to blood flow erosion. Coil embolization does not require craniotomy, has less trauma and better results.

[0003] At present, there are two ways of releasing the spring coils used in clinical practice, namely, electrolytic release and mechanical release. The electrolytic release spring coil uses a special release device to transmit current to the metal coil at the far end of the push rod for heating. The heated coil will melt the thin metal / polymer wire between the spring coil and the push rod inside the coil, so as to separate the spring coil and the push rod. The circuit stability of the electrolytic release spring coil is poor, and the melting release time is long, generally ranging from tens of seconds to several minutes. In addition, the size of the molten ball of the thin metal / polymer wire between the spring coil and the push rod is uncontrollable. Once the size of the molten ball is too large, there will be a high probability that the release cannot be achieved. Mechanical release is achieved through displacement between special mechanical structures. The current mainstream mechanical release is a trap structure, which is a hook and unhook release mechanism. The connection point of this structure is a movable connection point, which may cause deformation and lock the connection point, resulting in the risk of being unable to release or kicking the tube during delivery; in addition, the spring coil may be displaced during the process of pushing and pulling the limit wire of the connection hook, affecting the treatment effect.

[0004] For example, the utility model patent with the announcement number CN217907887U discloses an embolic spring coil, including a push tube, a first clamp, a push piece and a spring coil. The push piece is slidably connected in the push tube, the first clamp is set on the push tube, the first clamp shrinks in a natural state, the push piece can selectively abut against the first clamp to tighten the first clamp, the spring coil has a connecting portion, the first clamp extends into the connecting portion and is clamped with the connecting portion when tightened. The cooperation between the clamp and the connecting portion here is also the cooperation relationship between the clamp block and the clamp hole. The principle is the same as the principle of hooking and unhooking. The connection point is also a movable connection point, which is also easy to cause deformation to lock the connection point, resulting in the risk of being unable to release or kicking the tube during transportation.

[0005] In view of this, the inventor conducted in-depth research on this demand, and thus the present case was produced. Summary of the invention

[0006] In order to overcome the problems in the prior art that mechanical release easily causes deformation and locks the connection point, resulting in the risk of being unable to release or kicking the tube during delivery; and the spring coil may be displaced during the process of pushing and pulling the limit wire of the connection hook, affecting the treatment effect, the present invention provides a mechanical release spring coil system, including:

[0007] Loading tube;

[0008] an inner push rod, slidably connected in the loading tube;

[0009] A claw is arranged at the distal end of the inner push rod, and the inner push rod can selectively slide toward its distal end; when the claw slides with the inner push rod and is in the loading tube, it is restricted by the inner wall of the loading tube and is in a compressed state; when the claw is outside the loading tube, the claw is in a naturally expanded state;

[0010] as well as,

[0011] A spring ring, a limiting body is arranged at the proximal end of the spring ring, and can be detachably installed in the claw, wherein the limiting body is preferably a limiting ball.

[0012] Preferably, a push rod is provided at the proximal end of the loading tube, and the push rod is mounted on the inner push rod through a spring member and can move relative to the inner push rod along the central axis direction of the push rod; one end of the spring member abuts against the circumferential end surface of the proximal end of the push rod and the spring member is always in a compressed state;

[0013] The maximum outer diameter of the spring coil is greater than the inner diameter of the loading tube, and the minimum inner diameter of the spring coil is smaller than the outer diameter of the loading tube.

[0014] The claw is moved along the length direction of the loading tube in cooperation with the limit body by the cooperation between the loading tube, the spring part and the inner push rod. When the claw is in the loading tube, it is in a clamping state, and the limit body is held inside it. When the spring coil enters the diseased part, a thrust is manually given to the inner push rod. At this time, the claw connected to the inner push rod will be pushed out of the loading tube, and the claw is released and opened outside the loading tube. The limit body of the spring coil loses its constraint and escapes from the inside, thereby completing the release of the spring coil. This not only makes the release efficiency of the spring coil higher, but also reduces the risk of connection point locking due to loose connection points and spring coil displacement caused by the limit wire.

[0015] Herein, the term “proximal end” generally refers to the end of the corresponding component close to the operator, and the term “distal end” refers to the end of the corresponding component far from the operator.

[0016] Preferably, the spring coil further comprises a semicircular ball head, an anti-untwisting wire, a spring coil body and a connecting ring, one end of the anti-untwisting wire is fixed on the semicircular ball head, and the other end passes through the inner cavity of the connecting ring and is integrally connected to the limiting body, and the spring coil body is sleeved on the outer circumference of the anti-untwisting wire;

[0017] The outer diameter of the connecting ring is smaller than the inner diameter of the loading tube, and the outer diameter of the spring coil body is larger than the inner diameter of the loading tube. When the inner push rod has a tension force away from the spring coil, the spring coil will not be pulled back into the loading tube, and there is a certain tension between the spring coil and the loading tube. This tension can ensure that the spring coil is firmly fixed in this position and is not easily displaced.

[0018] Preferably, the spring coil body and one end of the anti-untwisting wire are covered and fixed by the semicircular ball head, and the other end of the spring coil body is fixedly mounted on the connecting ring.

[0019] Preferably, the semicircular ball head is a cured UV light-curing glue, that is, it is formed by UV light-curing glue droplets being irradiated with ultraviolet light; before the UV light-curing glue is cured, one end of the anti-untwisting wire is wrapped by the glue droplets, but the anti-untwisting wire does not leak out of the glue droplets, and the solidified UV light-curing glue wraps one end of the anti-untwisting wire for a firm bond.

[0020] Preferably, before the UV light-curing glue is cured, the UV light-curing glue is immersed in the spring coil body for 2 to 4 turns, so as to achieve effective bonding with the spring coil body.

[0021] Preferably, the anti-untwisting wire is a medical suture made of PP material; the PP material has high tensile strength and can effectively resist the untwisting of the spring coil body; the anti-untwisting wire is inside the spring coil body, and the soft PP wire can always change with the changes in the shape of the spring coil body.

[0022] Preferably, the spring coil body is formed by tightly winding a platinum-tungsten alloy wire material; platinum-tungsten alloy has good biocompatibility and excellent visibility under X-ray, and is an ideal material for making a spring coil body.

[0023] Preferably, the connecting ring is made of platinum-iridium material, which has good X-ray visibility and good weldability with platinum-tungsten material. Metallurgical bonding between the connecting ring and the spring coil body can be achieved through welding; the anti-untwisting wire passes through the inner cavity of the connecting ring, and the inner cavity of the connecting ring is filled with UV light-curing glue to achieve effective fixation.

[0024] Preferably, the limiter is made of PP material, and is an integrated structure with the anti-untwisting wire. The PP wire at the other end of the anti-untwisting wire is placed in the heated and melted PP liquid, and the limiter and the PP wire can be integrated after the PP liquid solidifies.

[0025] Preferably, the heated and molten PP liquid is placed in a specific mold in advance, and the mold can control the shape and size of the PP liquid after solidification, thereby controlling the shape and size of the limiting body.

[0026] Preferably, the stopper has a spherical structural feature, which is friendly to human tissue and will not damage the blood vessel wall. This structural feature is superior to the existing mechanical release connection structure; compared with the molten ball produced by electrolytic release, the molten ball produced by electrolytic release is more likely to be irregular.

[0027] Preferably, the claw comprises a collar, a branch rod and a ball head, a plurality of the branch rods are circumferentially distributed at one end of the collar, and the collar is sleeved on the inner push rod, and the ball head is formed on one end of each branch rod away from the collar.

[0028] Preferably, the claw is made of shape memory alloy material, preferably nickel-titanium alloy.

[0029] Preferably, the claw body is a nickel-titanium alloy tube cut integrally by laser cutting equipment. The nickel-titanium alloy has superelasticity and shape memory functions, and is suitable for parts requiring limiting and retracting functions.

[0030] Specifically, the collar is located at an end of the claw away from the spring ring, and is sleeved on an end of the inner push rod close to the spring ring.

[0031] Preferably, the number of branches on the ring is 3 to 8.

[0032] Specifically, the ball head is formed by laser melting the material of the free end of the branch rod, and the surface of the ball head is smooth.

[0033] Specifically, after the cutting and melting process, the claws are heat-set, and the shape memory property of nickel-titanium alloy is utilized to fix the claws in a prefabricated mold, put them in a heat treatment furnace, and after a suitable heat treatment process, the desired shape is obtained.

[0034] Preferably, the jaws are electrolytically polished after the cutting, ball melting and heat setting processes, and the electrolytic polishing can remove the surface oxide layer, slag and sharp particles.

[0035] Preferably, the loading tube is a tube made of PI material, and the push rod is a spiral cut hypotube made of stainless steel. Here, PI material has the advantages of high toughness, high strength and high wear resistance. The spiral cut hypotube can improve the flexibility of the push rod, making it easier for the product to pass through tortuous blood vessels and reach the lesion site.

[0036] Specifically, the loading tube is sleeved on one end of the pushing rod close to the spring coil, and is fixed on the outside of the tube using glue and a heat shrink tube.

[0037] Preferably, the inner diameter of the loading tube is larger than the outer diameter of the collar.

[0038] Specifically, the clamping claw can realize the release and compression gripping in the tube cavity of the loading tube, and the purpose of adjusting the clamping claw size can be achieved by changing the inner diameter of the loading tube.

[0039] Preferably, the inner push rod comprises a connecting rod, a supporting unit, a spring limiting step and an inner push rod hand-held pushing unit, the claw is sleeved on one end of the connecting rod close to the spring coil, the inner push rod hand-held pushing unit is arranged on one end of the connecting rod away from the claw, the spring limiting step is formed on the end surface of one end of the inner push rod hand-held pushing unit close to the claw, and one end of the spring member abuts against the spring limiting step;

[0040] The support unit is arranged between the clamping claw and the inner push rod handheld pushing unit, and the outer diameter of the support unit is clearance-matched with the inner diameter of the push rod.

[0041] Here, the spring element is preferably a compression spring, which can be made of stainless steel 301 or other materials.

[0042] Preferably, one end of the spring member is ground flat and welded to the circumferential end surface of the push rod away from the spring coil.

[0043] Specifically, the outer diameter of the spring member is slightly smaller than the outer diameter of the push rod, which can facilitate welding and subsequent assembly.

[0044] Preferably, the inner push rod is made of stainless steel wire through a grinder and laser processing, the spring limit step, the inner push rod handheld pushing unit and the push rod round head constitute a plug, and the connecting rod, the supporting unit, the spring limit step, the inner push rod handheld pushing unit and the push rod round head are coaxially arranged.

[0045] Preferably, the outer diameter of the connecting rod is transitionally matched with the inner diameter of the collar, and the connecting rod extends out of the collar to a suitable length, which can facilitate the release of the spring coil during the pushing process; the inner push rod is sleeved inside the pushing rod and maintains a coaxial center with the pushing rod.

[0046] Preferably, after the collar of the clamping claw is sleeved on a suitable position of the connecting rod of the inner push rod, welding or gluing is adopted at the connecting portion to ensure an effective fixed connection between the two.

[0047] Specifically, the outer diameter of the support unit is in clearance with the inner diameter of the push rod, and the support unit can ensure the transmission of the thrust in the length direction, so that the push rod is not easily bent or deformed during the pushing process, wherein there can be multiple support units.

[0048] Specifically, the spring limiting step cooperates with the spring member, and an end surface of the spring member can be blocked by the spring limiting step, and the compression of the spring member can be achieved by pushing the inner push rod.

[0049] Preferably, it further comprises an end cap, the inner wall of which is formed with an internal thread, and the outer circumferential surface of one end of the push rod away from the spring coil is formed with an external thread matching the internal thread on the end cap;

[0050] When the end cap is sleeved on the pushing rod, the end of the inner pushing rod away from the spring coil and the spring member are both located inside the end cap.

[0051] Specifically, the diameter of the inner push rod handheld pushing unit is smaller than the inner diameter of the end cap.

[0052] Specifically, the length of the spring member is greater than the length of the inner cavity of the end cap, so that after the end cap is assembled, the spring member is in a compressed state.

[0053] Preferably, the end cap comprises a tube body and an end cap round head, and an internal thread is formed on the inner wall of the tube body near the end cap opening.

[0054] Preferably, the end cap is made of stainless steel.

[0055] Specifically, the internal thread cooperates with the external thread on the push rod. When the end cap is connected to the push rod and the thread is tightened, the spring member will be compressed between the end face of the push rod away from the spring coil and the inner push rod spring limit step. There is a certain tension inside the compressed spring, and there is a tendency to pull the inner push rod back away from the end of the spring coil.

[0056] Specifically, because the spring element is a compression spring and its length is greater than the length of the inner cavity of the end cap, when the thread is tightened, the spring element is in a compressed state. No matter where the inner push rod is located in the end cap, there is always tension between the inner push rod and the push rod. This tension will cause the push rod to pull the inner push rod back from the end away from the spring coil. Since the inner push rod is connected to one end close to the spring coil with a claw, the claw tightly holds the limiter of the spring coil in the contracted state, and since the outer diameter of the spring coil is greater than the inner diameter of the loading tube, the spring coil cannot enter the loading tube under this tension, but is pulled by the inner push rod to be constrained on the push system.

[0057] Specifically, the round head of the end cap matches with the round head of the inner push rod, and the diameter of the round head of the end cap is larger than that of the round head of the inner push rod, so that assembly is convenient.

[0058] The special structure of the claw made of nickel-titanium alloy is connected to the inner push rod; the claw is pressed and gripped in the loading tube, and the pressed claw tightly holds the limiter of the spring coil; after the end cap is tightened, the inner push rod tends to be pulled toward the end cap under the action of the spring member, and this tension can firmly fix the spring coil on the push structure as a whole. When the product enters the lesion site, unscrew the end cap and continue to manually give a thrust to the inner push rod. At this time, the claw connected to the inner push rod will be pushed out of the loading tube. Due to the shape memory characteristics of nickel-titanium alloy, the claw will be released and opened outside the loading tube, and the limiter of the spring coil loses its constraint, completing the release of the spring coil.

[0059] The present invention also provides a method for manufacturing the above-mentioned mechanical release spring coil system, comprising:

[0060] Put the carrier tube on one end of the push rod and fix it with glue and heat shrink tube at the external connection;

[0061] The carrier tube sleeve and the push rod are sleeved outside the inner push rod, and one end of the spring member is welded to the circumferential end surface of the push rod away from the carrier tube sleeve, and the other end is pressed against the inner push rod;

[0062] The claw is installed at one end of the inner push rod close to the carrier tube sleeve, and the limiter of the spring ring is placed in the claw. The claw is compressed by external force and the spring ring and the claw are pushed to move into the carrier tube sleeve. Further, under the action of the spring member, the claw is kept balanced at a specific position inside the carrier tube sleeve.

[0063] The preparation process of the spring coil is as follows:

[0064] Pass the anti-untwisting wire through the inner cavity of the connecting ring, so that the connecting ring is located on the anti-untwisting wire; start from one end of the anti-untwisting wire and tightly wind the platinum-tungsten alloy wire material on the outer circumference of the anti-untwisting wire to the position of the connecting ring to form a spring coil body;

[0065] Fix one end of the spring coil body on the connecting ring, and wrap UV light-curing glue on one end of the spring coil body and the anti-untwisting wire combination structure, and form a semicircular ball head by ultraviolet light irradiation; fill the UV light-curing glue into the inner cavity of the connecting ring, and cure it by ultraviolet light irradiation;

[0066] The other end of the anti-untwisting wire is placed in a spherical structure mold containing heated molten PP liquid, and a limiter is formed after the PP liquid solidifies;

[0067] The preparation process of the claws is as follows:

[0068] The nickel-titanium alloy tube is cut into a branch rod by laser cutting equipment, and the material at the distal end of the branch rod is melted by laser to form a ball head; the claw is fixed to a prefabricated mold and then placed in a heat treatment furnace. After the heat treatment process, the claw of the expected shape is obtained.

[0069] The present invention also provides a method for using the mechanical release spring coil system.

[0070] When the spring coil enters the lesion, a thrust is given to the inner push rod to push the claw connected to the inner push rod out from the inside of the loading tube. The claw will be released and opened outside the loading tube, and the limit body of the spring coil loses its constraint, completing the release of the spring coil.

[0071] Beneficial effects:

[0072] The beneficial effects produced by the technical solution of the present invention are as follows:

[0073] (1) The claw is moved along the length of the loading tube by cooperating with the limiter, and the loading tube, the spring part and the inner push rod. When the claw is in the loading tube, it is in a clamping state, and the limiter is held inside it. When the spring coil enters the lesion site, a thrust is manually applied to the inner push rod. At this time, the claw connected to the inner push rod will be pushed out of the loading tube, and the claw is released and opened outside the loading tube. The limiter of the spring coil loses its constraint and escapes from the inside, thereby completing the release of the spring coil. This not only makes the release of the spring coil more efficient, but also reduces the risk of connection point locking due to loose connection points and the risk of spring coil displacement due to the limiter wire.

[0074] (2) The loading tube is made of PI material, and the push rod is a spiral cut hypotube made of stainless steel. Here, PI material has the advantages of high toughness, high strength and high wear resistance, while the spiral cut hypotube can improve the softness of the push rod, making it easier for the product to pass through tortuous blood vessels and reach the lesion site.

[0075] (3) The spring coil body is formed by tightly winding a platinum-tungsten alloy wire material; platinum-tungsten alloy has good biocompatibility and excellent visibility under X-ray, and is an ideal material for making a spring coil body.

[0076] (4) The limiting body has a spherical structural feature, which is friendly to human tissue and will not cause damage to the blood vessel wall. This structural feature is superior to the existing mechanical release connection structure. Compared with the molten ball produced by electrolytic release, the molten ball produced by electrolytic release is more likely to be irregular. BRIEF DESCRIPTION OF THE DRAWINGS

[0077] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0078] Figure 1 It is a schematic diagram of the structure of a preferred mechanical release spring coil system of the present invention in an unreleased state;

[0079] Figure 2 It is a schematic diagram of the structure of a preferred mechanical release spring coil system of the present invention in a released state;

[0080] Figure 3 It is a schematic diagram of the three-dimensional structure of the preferred clamping claw of the present invention in an expanded state;

[0081] Figure 4 It is a schematic diagram of the three-dimensional structure of the preferred clamping claw of the present invention in a pressed gripping state;

[0082] Figure 5 It is a schematic structural diagram of a preferred spring coil of the present invention;

[0083] Figure 6 It is a partial structural schematic diagram of a preferred spring coil system of the present invention;

[0084] Figure 7 It is a schematic diagram of the three-dimensional structure of a preferred inner push rod of the present invention;

[0085] Figure 8 It is a schematic diagram of the three-dimensional structure of a preferred end cap of the present invention. DETAILED DESCRIPTION

[0086] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the claimed invention, but merely represents the selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0087] like Figure 1 and 2 As shown, the mechanical spring coil release system includes: a loading tube 3; an inner push rod 6, which is slidably connected in the loading tube 3; a claw 2, which is arranged at the distal end of the inner push rod 6, and the inner push rod 6 can selectively slide toward the distal end of the inner push rod 6; when the claw 2 slides with the inner push rod 6 and is in the loading tube 3, it is restricted by the inner wall of the loading tube 3 to be in a compressed state; when the claw 2 is outside the loading tube 3, the claw 2 is in a naturally expanded state;

[0088] And a spring coil 1, a limiting body 11 is arranged at the proximal end of the spring coil 1, and can be detachably installed in the claw 2, wherein the limiting body 11 is preferably a limiting ball.

[0089] As a preferred embodiment, a push rod 4 is provided at the proximal end of the loading tube 3, and the push rod 4 is installed on the inner push rod 6 through a spring member 5 and can move relative to the inner push rod 6 along the central axis direction of the push rod 6; one end of the spring member 5 abuts against the circumferential end surface of the proximal end of the push rod 4 and the spring member 5 is always in a compressed state;

[0090] The maximum outer diameter of the spring coil 1 is greater than the inner diameter of the loading tube 3 , and the minimum inner diameter of the spring coil 1 is smaller than the outer diameter of the loading tube 3 .

[0091] When the claw 2 is located inside the loading tube 3, it is in a pressed gripping state and a gripping space is formed inside to hold the limiting body 11. When the claw is located outside the loading tube, it is in an expanded state, the limiting body of the spring coil loses its constraint, and the spring coil is released.

[0092] The claw is moved along the length direction of the loading tube in cooperation with the limit body by the cooperation between the loading tube, the spring part and the inner push rod. When the claw is in the loading tube, it is in a clamping state, and the limit body is held inside it. When the spring coil enters the diseased part, a thrust is manually given to the inner push rod. At this time, the claw connected to the inner push rod will be pushed out of the loading tube, and the claw is released and opened outside the loading tube. The limit body of the spring coil loses its constraint and escapes from the inside, thereby completing the release of the spring coil. This not only makes the release efficiency of the spring coil higher, but also reduces the risk of connection point locking due to loose connection points and spring coil displacement caused by the limit wire.

[0093] Herein, the term “proximal end” generally refers to the end of the corresponding component close to the operator, and the term “distal end” refers to the end of the corresponding component far from the operator.

[0094] As a preferred embodiment, Figure 3 As shown, the spring coil 1 also includes a semicircular ball head 12, an anti-untwisting wire 13, a spring coil body 14 and a connecting ring 15, one end of the anti-untwisting wire 13 is fixed on the semicircular ball head 12, and the other end passes through the inner cavity of the connecting ring 15 and is integrated with the limiting body 11, and the spring coil body 14 is sleeved on the outer circumference of the anti-untwisting wire 13;

[0095] The outer diameter of the connecting ring 15 is smaller than the inner diameter of the loading tube 3, and the outer diameter of the spring coil body 14 is larger than the inner diameter of the loading tube 3. When the inner push rod 6 has a tension force away from the spring coil 1, the spring coil 1 will not be pulled back into the loading tube 3, and there is a certain tension between the spring coil 1 and the loading tube 3. This tension can ensure that the spring coil 1 is firmly fixed in this position and is not easily displaced.

[0096] The spring coil body 14 and one end of the anti-untwisting wire 13 are covered and fixed by the semicircular ball head 12 , and the other end of the spring coil body 14 is fixedly mounted on the connecting ring 15 .

[0097] The semicircular ball head 12 is a cured UV light-curing glue, that is, it is formed by UV light-curing glue droplets being irradiated with ultraviolet light; before the UV light-curing glue is cured, one end of the anti-untwisting wire 13 is wrapped by the glue droplets, but the anti-untwisting wire 13 does not leak out of the glue droplets, and the solidified UV light-curing glue wraps one end of the anti-untwisting wire 13 and is firmly bonded.

[0098] Before the UV light-curing glue is cured, the UV light-curing glue is immersed in the spring coil body 2 to 4 circles, which can achieve effective combination with the spring coil body 14.

[0099] The anti-untwisting thread 13 is a medical suture thread made of PP material; the PP material has high tensile strength and can effectively resist the untwisting of the spring coil; the anti-untwisting thread is inside the spring coil, and the soft PP thread can always change with the changes in the shape of the spring coil.

[0100] The spring coil body 14 is formed by tightly winding a platinum-tungsten alloy wire material; the platinum-tungsten alloy has good biocompatibility and excellent visibility under X-rays, and is an ideal material for making the spring coil body 14 .

[0101] As a preferred embodiment, the connecting ring 15 is made of platinum-iridium material, which has good X-ray visibility and good weldability with platinum-tungsten material. Metallurgical bonding between the connecting ring and the spring coil body can be achieved through welding; the anti-untwisting wire 13 passes through the inner cavity of the connecting ring 15, and the inner cavity of the connecting ring 15 is filled with UV light-curing glue to achieve effective fixation.

[0102] As a preferred embodiment, the limiter 11 is made of PP material, and the limiter 11 is an integrated structure with the anti-untwisting wire 13. The PP wire at the other end of the anti-untwisting wire 13 is placed in the heated and melted PP liquid. After the PP liquid solidifies, the limiter 11 and the PP wire can be integrated.

[0103] As a preferred embodiment, the heated and molten PP liquid is placed in a specific mold in advance, and the mold can control the shape and size of the PP liquid after solidification, thereby controlling the shape and size of the limiting body.

[0104] As a preferred embodiment, the stopper 11 has a spherical structural feature, which is friendly to human tissue and will not damage the blood vessel wall. This structural feature is superior to the existing mechanical release connection structure; compared with the molten ball produced by electrolytic release, the molten ball produced by electrolytic release is more likely to be irregular.

[0105] As a preferred embodiment, Figure 4 and 5 As shown, the claw 2 includes a ring 21, a branch rod 22 and a ball head 23. A plurality of the branch rods 22 are circumferentially distributed at one end of the ring 21, and the ring 21 is sleeved on the inner push rod 6. The ball head 23 is formed on the end of each branch rod 22 away from the ring 21.

[0106] As a preferred embodiment, the claw 2 is made of shape memory alloy material, preferably nickel-titanium alloy.

[0107] Specifically, the claw body is made of a nickel-titanium alloy tube cut in one piece by laser cutting equipment. The nickel-titanium alloy has superelasticity and shape memory functions and is suitable for parts requiring limiting and retracting functions.

[0108] Specifically, the collar 21 is located at the end of the claw 2 away from the spring coil 1, and is sleeved on the end of the inner push rod 6 close to the spring coil 1; and the number of the branches 22 on the collar 21 is preferably 3 to 8.

[0109] Specifically, the ball head 23 is formed by laser melting the material of the free end of the branch rod 22, and the surface of the ball head is smooth.

[0110] Specifically, after the cutting and melting process, the clamping claw 2 is heat-set, and the shape memory property of nickel-titanium alloy is utilized to fix the clamping claw 2 in a prefabricated mold, and put it into a heat treatment furnace, and after a suitable heat treatment process, the desired shape is obtained.

[0111] Here, the jaws 2 are electrolytically polished after the cutting, ball melting and heat setting processes, and the electrolytic polishing can remove the surface oxide layer, slag and sharp particles.

[0112] As a preferred embodiment, the loading tube 3 is a tube made of PI material, and the push rod 4 is a spiral cut hypotube made of stainless steel. Here, the PI material has the advantages of high toughness, high strength and high wear resistance. The spiral cut hypotube can improve the flexibility of the push rod, making it easier for the product to pass through tortuous blood vessels and reach the lesion site.

[0113] Specifically, the loading tube 3 is sleeved on one end of the pushing rod 4 close to the spring coil 1 and is fixed on the outside of the tube using glue and a heat shrink tube.

[0114] The inner diameter of the loading tube 3 is larger than the outer diameter of the collar 21 .

[0115] Specifically, the clamping claw 2 can realize the release and compression gripping in the lumen of the loading tube 3 , and the purpose of adjusting the compression gripping size of the clamping claw 1 can be achieved by changing the inner diameter of the loading tube 3 .

[0116] As a preferred embodiment, the inner push rod 6 comprises a connecting rod 61, a supporting unit 62, a spring limiting step 63 and an inner push rod hand-held pushing unit 64, the claw 2 is sleeved on the end of the connecting rod 61 close to the spring coil 1, the inner push rod hand-held pushing unit 64 is arranged on the end of the connecting rod 61 away from the claw 2, the spring limiting step 63 is formed on the end surface of the inner push rod hand-held pushing unit 64 close to the claw 2, and one end of the spring member 5 is pressed against the spring limiting step 63;

[0117] The support unit 62 is disposed between the claw 2 and the inner push rod handheld pushing unit 64 , and the outer diameter of the support unit 62 is clearance-matched with the inner diameter of the push rod 4 .

[0118] Here, the spring member 5 is preferably a compression spring, and can be made of stainless steel 301 or other materials.

[0119] As a preferred embodiment, one end of the spring member 5 is ground flat and welded to the circumferential end surface of the push rod 4 away from the spring coil 1.

[0120] Specifically, the outer diameter of the spring member 1 is slightly smaller than the outer diameter of the push rod 4 , which can facilitate welding and subsequent assembly.

[0121] Here, the inner push rod 6 is made of stainless steel wire through a grinder and laser processing, and the spring limiting step 63, the inner push rod handheld pushing unit 64 and the push rod round head 65 constitute a plug, and the connecting rod 61, the supporting unit 62, the spring limiting step 63, the inner push rod handheld pushing unit 64 and the push rod round head 65 are coaxially arranged.

[0122] Among them, the outer diameter of the connecting rod 61 is transitionally matched with the inner diameter of the ring 21, and the distal end of the connecting rod 61 extends out of the ring 21 by an appropriate length, which can facilitate the release of the spring coil 1 during the pushing process; the inner push rod 6 is sleeved inside the pushing rod 4 and maintains the same axis as the pushing rod 4.

[0123] When the collar 21 of the clamping claw 2 is sleeved on a suitable position at the distal end of the connecting rod 61 of the inner push rod 6, welding or gluing is used at the connecting portion to ensure an effective fixed connection between the two.

[0124] Specifically, the outer diameter of the support unit 62 is loosely matched with the inner diameter of the push rod 4, and the support unit 62 can ensure the transmission of the thrust in the length direction, so that the push rod 4 is not prone to bending and deformation during the pushing process, wherein there can be multiple support units 62.

[0125] Specifically, the spring limiting step 63 cooperates with the spring member 5 , and an end surface of the spring member 5 can be blocked by the spring limiting step 63 , and the compression of the spring member 5 can be achieved by pushing the inner push rod 6 .

[0126] As a preferred embodiment, it further comprises an end cap 7, an inner wall of which is formed with an internal thread 711, and an outer circumferential surface of one end of the push rod 4 away from the spring coil 1 is formed with an external thread 41 matching the internal thread 711 on the end cap 7;

[0127] When the end cap is sleeved on the pushing rod, the end of the inner pushing rod away from the spring coil and the spring member are both located inside the end cap.

[0128] Specifically, the diameter of the inner push rod handheld pushing unit 64 is smaller than the inner diameter of the end cap 7 .

[0129] Specifically, the length of the spring member 5 is greater than the length of the inner cavity of the end cap 7, so that after the end cap 7 is assembled, the spring member 5 is in a compressed state.

[0130] As a preferred embodiment, the end cap 7 includes a tube body 71 and an end cap round head 72 , and an internal thread 711 is formed on the inner wall of the tube body 71 near the end cap opening.

[0131] Wherein, the end cap 7 is made of stainless steel.

[0132] Specifically, the internal thread 711 cooperates with the external thread 41 on the push rod 4. When the end cap is connected to the push rod 4 and the thread is tightened, the spring member 5 will be compressed between the end face of the push rod 4 away from the spring coil 1 and the inner push rod spring limiting step 63. There is a certain tension inside the compressed spring, and there is a tendency to pull the inner push rod 6 back to the end away from the spring coil 1.

[0133] Specifically, because the spring member 5 is a compression spring and its length is greater than the length of the inner cavity of the end cap, when the thread is tightened, the spring member is in a compressed state. No matter where the inner push rod is located in the end cap, there is always tension between the inner push rod and the push rod, and this tension will produce a tendency for the push rod to pull the inner push rod back from the end away from the spring coil. Since the inner push rod is connected to one end close to the spring coil with a claw, the claw tightly holds the limiter of the spring coil in the contracted state, and since the outer diameter of the spring coil is greater than the inner diameter of the loading tube, the spring coil cannot enter the loading tube under this tension, but is pulled by the inner push rod to be constrained on the push system.

[0134] Specifically, the end cap round head 72 matches with the inner push rod round head 65 , and the diameter of the end cap round head 72 is larger than that of the inner push rod round head 65 , so as to facilitate assembly.

[0135] The special structure of the claw made of nickel-titanium alloy is connected to the inner push rod; the claw is pressed and gripped in the loading tube, and the pressed claw tightly holds the limiter of the spring coil; after the end cap is tightened, the inner push rod tends to be pulled toward the end cap under the action of the spring member, and this tension can firmly fix the spring coil on the push structure as a whole. When the product enters the lesion site, unscrew the end cap and continue to manually give a thrust to the inner push rod. At this time, the claw connected to the inner push rod will be pushed out of the loading tube. Due to the shape memory characteristics of nickel-titanium alloy, the claw will be released and opened outside the loading tube, and the limiter of the spring coil loses its constraint, completing the release of the spring coil.

[0136] This embodiment also provides a method for manufacturing the above-mentioned mechanical release spring coil system.

[0137] Put the carrier tube on one end of the push rod and fix it with glue and heat shrink tube at the external connection;

[0138] The carrier tube sleeve and the push rod are sleeved outside the inner push rod, and one end of the spring member is welded to the circumferential end surface of the push rod away from the carrier tube sleeve, and the other end is pressed against the inner push rod;

[0139] The claw is installed at one end of the inner push rod close to the carrier tube sleeve, and the limiter of the spring ring is placed in the claw. The claw is compressed by external force and the spring ring and the claw are pushed to move into the carrier tube sleeve. Further, under the action of the spring member, the claw is kept balanced at a specific position inside the carrier tube sleeve.

[0140] The preparation process of the spring coil is as follows:

[0141] Pass the anti-untwisting wire through the inner cavity of the connecting ring, so that the connecting ring is located on the anti-untwisting wire; start from one end of the anti-untwisting wire and tightly wind the platinum-tungsten alloy wire material on the outer circumference of the anti-untwisting wire to the position of the connecting ring to form a spring coil body;

[0142] Fix one end of the spring coil body on the connecting ring, and wrap UV light-curing glue on one end of the spring coil body and the anti-untwisting wire combination structure, and form a semicircular ball head by ultraviolet light irradiation; fill the UV light-curing glue into the inner cavity of the connecting ring, and cure it by ultraviolet light irradiation;

[0143] The other end of the anti-untwisting wire is placed in a spherical structure mold containing heated molten PP liquid, and a limiter is formed after the PP liquid solidifies;

[0144] The preparation process of the claws is as follows:

[0145] The nickel-titanium alloy tube is cut into a branch rod by laser cutting equipment, and the material at the distal end of the branch rod is melted by laser to form a ball head; the claw is fixed to a prefabricated mold and then placed in a heat treatment furnace. After the heat treatment process, the claw of the expected shape is obtained.

[0146] This embodiment also provides a method for using the above-mentioned mechanical release spring coil system.

[0147] When the spring coil enters the lesion, a thrust is given to the inner push rod to push the claw connected to the inner push rod out from the inside of the loading tube. The claw will be released and opened outside the loading tube, and the limit body of the spring coil loses its constraint, completing the release of the spring coil.

[0148] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A mechanical spring coil release system, characterized in that: include: Loading tube; an inner push rod, slidably connected in the loading tube; A claw is arranged at the distal end of the inner push rod, and the inner push rod can selectively slide toward its distal end; when the claw slides with the inner push rod and is in the loading tube, it is restricted by the inner wall of the loading tube and is in a compressed state; when the claw is outside the loading tube, the claw is in a naturally expanded state; as well as, A spring ring, a limiter is provided at the proximal end of the spring ring and can be detachably installed in the claw; A push rod is provided at the proximal end of the loading tube, and the push rod is mounted on the inner push rod through a spring member and can move relative to the inner push rod along the central axis direction of the push rod; one end of the spring member abuts against the circumferential end surface of the proximal end of the push rod and the spring member is always in a compressed state; The maximum outer diameter of the spring coil is greater than the inner diameter of the loading tube, and the minimum inner diameter of the spring coil is smaller than the outer diameter of the loading tube; The inner push rod comprises a connecting rod, a supporting unit, a spring limiting step and an inner push rod hand-held pushing unit, wherein the inner push rod hand-held pushing unit is arranged at an end of the connecting rod away from the clamping claw, and the spring limiting step is formed on an end surface of the inner push rod hand-held pushing unit close to the clamping claw, and one end of the spring member abuts against the spring limiting step; It also includes an end cap, the inner wall of which is formed with an internal thread, and the outer circumferential surface of one end of the push rod away from the spring coil is formed with an external thread matching the internal thread on the end cap; When the end cap is sleeved on the pushing rod, the end of the inner pushing rod away from the spring coil and the spring member are both located inside the end cap.

2. A mechanical spring coil release system according to claim 1, characterized in that: The spring coil also includes a semicircular ball head, an anti-untwisting wire, a spring coil body and a connecting ring, one end of the anti-untwisting wire is fixed on the semicircular ball head, and the other end passes through the inner cavity of the connecting ring and is integrally connected to the limiting body, and the spring coil body is sleeved on the outer circumference of the anti-untwisting wire; The outer diameter of the connecting ring is smaller than the inner diameter of the loading tube, and the outer diameter of the spring coil body is larger than the inner diameter of the loading tube.

3. A mechanical spring coil release system according to claim 2, characterized in that: The spring coil body and one end of the anti-untwisting wire are covered and fixed by the semicircular ball head, and the other end of the spring coil body is fixedly installed on the connecting ring.

4. A mechanical spring coil release system according to claim 1, characterized in that: The clamping claw comprises a collar, a branch rod and a ball head. A plurality of the branch rods are circumferentially distributed at one end of the collar, and the collar is sleeved on the inner push rod. The ball head is formed on one end of each branch rod away from the collar.

5. A mechanical spring coil release system according to claim 1, characterized in that: The loading tube is a tube made of PI material, and the pushing rod is a spirally cut hypotube made of stainless steel.

6. A mechanical spring coil release system according to claim 1, characterized in that: The clamping claw is sleeved on one end of the connecting rod close to the spring ring, the supporting unit is arranged between the clamping claw and the inner push rod handheld pushing unit, and the outer diameter of the supporting unit is clearance-matched with the inner diameter of the pushing rod.

7. A method for manufacturing a mechanical release spring coil system according to any one of claims 1 to 6, characterized in that: Put the carrier tube on one end of the push rod and fix it with glue and heat shrink tube at the external connection; The tube sleeve and the push rod are sleeved outside the inner push rod, and one end of the spring member is welded to the circumferential end surface of the push rod away from the tube sleeve, and the other end is pressed against the inner push rod; the clamping claw is installed on the end of the inner push rod close to the tube sleeve, and the limiter of the spring ring is placed in the clamping claw, and the clamping claw is compressed by external force to push the spring ring and the clamping claw to move into the tube sleeve, and further under the action of the spring member, the clamping claw maintains balance at a specific position inside the tube sleeve; The preparation process of the spring coil is as follows: Pass the anti-untwisting wire through the inner cavity of the connecting ring, so that the connecting ring is located on the anti-untwisting wire; start from one end of the anti-untwisting wire and tightly wind the platinum-tungsten alloy wire material on the outer circumference of the anti-untwisting wire to the position of the connecting ring to form a spring coil body; Fix one end of the spring coil body on the connecting ring, and wrap UV light-curing glue on one end of the spring coil body and the anti-untwisting wire combination structure, and form a semicircular ball head by ultraviolet light irradiation; fill the UV light-curing glue into the inner cavity of the connecting ring, and cure it by ultraviolet light irradiation; The other end of the anti-untwisting wire is placed in a spherical structure mold containing heated molten PP liquid, and a limiter is formed after the PP liquid solidifies; The preparation process of the claws is as follows: The nickel-titanium alloy tube is cut into a branch rod by laser cutting equipment, and the material at the distal end of the branch rod is melted by laser to form a ball head; the claw is fixed to a prefabricated mold and then placed in a heat treatment furnace. After the heat treatment process, the claw of the expected shape is obtained.

8. A method for using the mechanical release spring coil system according to any one of claims 1 to 6, characterized in that: When the spring coil enters the lesion site, unscrew the end cap, give the inner push rod a thrust, push the claw connected to the inner push rod out from the inside of the loading tube, the claw will be released and opened outside the loading tube, the limit body of the spring coil loses its constraint, and the spring coil is released.

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