An integrated device for assisting in the formation of the neck of an intracranial aneurysm and its method of use

Abstract

The present invention relates to an integrated device for assisting in the formation of the aneurysm neck of an intracranial aneurysm and a method for using the same. The device includes a tip, a stent, a delivery tube, a traction wire, a connecting member, a locking sleeve, and a support wire. The tip, the stent, and the delivery tube are connected in sequence from the distal end to the proximal end. The traction wire passes through the tip, the stent, and the delivery tube and exits from the delivery tube. The support wire is connected to the delivery tube through the connecting member. The locking sleeve is sleeved outside the traction wire and the support wire and is used to control the locking or loosening of the traction wire and the support wire. An electrolytic detachment area is provided between the distal end wire winding section of the stent and the traction wire, and a hydrolytic detachment area is provided between the proximal end wire winding section of the stent and the delivery tube. The device provided by the present invention can pass through a microcatheter with a smaller diameter; before the coil is implanted, the aneurysm orifice can be fully expanded, which can not only assist the coil filling to avoid insufficient coil filling, but also play a role in guiding blood flow.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to an integrated device for assisting in the formation of the aneurysm neck of an intracranial aneurysm and a using method thereof. Background Art

[0002] An aneurysm is a manifestation of local or diffuse dilation or bulging of the arterial wall due to lesions or injuries of the arterial wall. The main treatment methods for aneurysms are craniotomy and endovascular interventional treatment. Among them, the operation of clipping the aneurysm neck by craniotomy is difficult and causes great trauma to the patient; while the endovascular interventional treatment is relatively less difficult and causes less trauma to the patient, and the overall prognosis is better than that of craniotomy. Therefore, endovascular interventional treatment of intracranial aneurysms has gradually become the preferred method for treating aneurysms. At present, endovascular interventional treatment most commonly uses coil embolization of aneurysms. Before inserting the coils, it is usually necessary to fully dilate the aneurysm orifice to avoid leaving gaps after the coils are packed. Summary of the Invention

[0003] The present invention provides an integrated device for assisting in the formation of the aneurysm neck of an intracranial aneurysm and a using method thereof to solve the above technical problems.

[0004] To solve the above technical problems, the present invention provides an integrated device for assisting in the formation of the aneurysm neck of an intracranial aneurysm, including a tip, a stent, a delivery tube, a traction wire, a connecting member, a locking sleeve, and a support wire.

[0005] The tip, the stent, and the delivery tube are sequentially connected from the distal end to the proximal end. The traction wire passes through the tip, the stent, and the delivery tube and exits from the delivery tube.

[0006] The support wire is connected to the delivery tube through the connecting member.

[0007] The locking sleeve is sleeved outside the traction wire and the support wire and is used to control the locking or loosening of the traction wire and the support wire.

[0008] There is an electrolytic detachment area between the distal end wire-wound section of the stent and the traction wire, and a hydrolytic detachment area between the proximal end wire-wound section of the stent and the delivery tube.

[0009] Preferably, radiopaque rings are respectively sleeved on the distal end wire-wound section and the proximal end wire-wound section of the stent.

[0010] Preferably, the tip has a curvature.

[0011] Preferably, the stent is woven from radiopaque nitinol wire.

[0012] Preferably, the wire diameter φ of the radiopaque nitinol wire is 0.05 mm to 0.1 mm.

[0013] Preferably, the wire diameter φ of the developable nitinol wire is 0.05 mm, 0.055 mm, 0.06 mm, 0.065 mm, 0.07 mm, 0.075 mm, 0.08 mm, 0.085 mm, 0.09 mm, 0.095 mm or 0.1 mm.

[0014] Preferably, the stent is woven from 8-strand, 10-strand, 12-strand or 16-strand developable nitinol wire.

[0015] The present invention also provides a method for using the intracranial aneurysm neck assisting and shaping integrated device as described above, including the following steps:

[0016] Step 1: After pushing the stent into place, adjust the traction wire so that the outer diameter of the stent meets the requirements, and then lock the locking sleeve;

[0017] Step 2: Fill the aneurysm with a detachable coil;

[0018] Step 3: Disconnect the electrolytic detachment area;

[0019] Step 4: Loosen the locking sleeve and withdraw the traction wire;

[0020] Step 5: Disconnect the hydrolytic detachment area.

[0021] Preferably, Step 3 includes: clamping the power supply of the electrolytic detachment device on the uncoated surface of the end of the traction wire, and energizing to disconnect the electrolytic detachment area.

[0022] Preferably, Step 5 includes: advancing a microcatheter to the hydrolytic detachment area and injecting undiluted contrast agent to disconnect the hydrolytic detachment area.

[0023] Compared with the prior art, the intracranial aneurysm neck assisting and shaping integrated device and its using method provided by the present invention have the following advantages:

[0024] 1. The device provided by the present invention can pass through a microcatheter with a smaller diameter; before inserting the detachable coil, it can fully expand the aneurysm orifice, which can not only assist the filling of the detachable coil but also play a role in guiding blood flow;

[0025] 2. The present invention is provided with an electrolytic detachment area and a hydrolytic detachment area, and different detachment methods can be used to disconnect according to the disconnection requirements at different stages, improving the safety during the operation. Description of the Drawings

[0026] Figure 1 It is a schematic structural diagram of the intracranial aneurysm neck assisting and shaping integrated device in a specific embodiment of the present invention;

[0027] Figure 2It is an enlarged view of the electrolytic detachment area in a specific embodiment of the present invention;

[0028] Figure 3 It is an enlarged view of the hydrolysis detachment area in a specific embodiment of the present invention;

[0029] Figures 4a to 4d They are respectively flowcharts of the usage methods of the integrated device for assisting in the formation of the aneurysm neck of an intracranial aneurysm in a specific embodiment of the present invention.

[0030] In the figure: 01 - microcatheter, 10 - tip, 20 - stent, 21 - distal wire winding section, 22 - proximal wire winding section, 30 - push tube, 31 - hydrolysis detachment area, 40 - traction wire, 41 - electrolytic detachment area, 50 - connecting piece, 60 - locking sleeve, 70 - support wire, 80 - radiopaque ring. Specific Embodiment

[0031] In order to describe the technical solutions of the above - mentioned invention in more detail, specific embodiments are listed below to prove the technical effects; it should be emphasized that these embodiments are used to illustrate the present invention and not to limit the scope of the present invention.

[0032] The integrated device for assisting in the formation of the aneurysm neck of an intracranial aneurysm provided by the present invention, as Figure 1 shown, includes a tip 10, a stent 20, a push tube 30, a traction wire 40, a connecting piece 50, a locking sleeve 60, and a support wire 70, wherein:

[0033] The tip 10, the stent 20, and the push tube 30 are connected in sequence from the distal end to the proximal end. The traction wire 40 passes through the tip 10, the stent 20, and the push tube 30 and exits from the push tube 30; the support wire 70 is connected to the push tube 30 through the connecting piece 50. By pushing and pulling the traction wire 40, the traction wire 40 can be pulled back and rebound relative to the support wire 70, thereby realizing the expansion and contraction of the stent 30, and then changing the outer diameter of the stent 20 to meet the needs of the operator.

[0034] The locking sleeve 60 is sleeved outside the traction wire 40 and the support wire 70 and is used to control the locking or loosening of the traction wire 40 and the support wire 70. In other words, when the locking sleeve 60 is locked, the relative positions of the traction wire 40 and the support wire 70 remain unchanged, and the outer diameter of the stent 30 remains fixed; when the locking sleeve 60 is loosened, the traction wire 40 and the support wire 70 can move relative to each other, facilitating the withdrawal of the traction wire 40.

[0035] Please refer to Figure 2 and Figure 3, an electrolytic detachment area 41 is provided between the distal wire winding section 21 of the stent 20 and the traction wire 40, and a hydrolytic detachment area 31 is provided between the proximal wire winding section 22 of the stent 20 and the push tube 30. The electrolytic detachment area 41 is an area that is disconnected by means of electrification. For example, an electroactive polymer can be used to connect the distal wire winding section 21 and the traction wire 40; the hydrolytic detachment area 31 is an area that is disconnected when encountering an aqueous solvent. For example, the proximal wire winding section 22 and the push tube 30 can be connected by an adhesive method.

[0036] The device provided by the present invention can pass through a microcatheter 01 with a smaller diameter; before the coil is implanted, the aneurysm orifice can be fully expanded, which can not only assist the coil filling but also play a role in guiding blood flow; in addition, the present invention sets an electrolytic detachment area 41 and a hydrolytic detachment area 31, and different detachment methods can be used for detachment according to the detachment requirements in different stages, improving the safety during the operation.

[0037] In some embodiments, please continue to refer to Figure 1 , imaging rings 80 are respectively sleeved on the distal wire winding section 21 and the proximal wire winding section 22 of the stent 20, which is convenient for the operator to accurately identify the position of the stent 20. In some embodiments, the imaging rings 80 can be welded and fixed to the distal wire winding section 21 and the proximal wire winding section 22 at both ends of the stent 20 to ensure firm connection.

[0038] In some embodiments, please continue to refer to Figure 1 , the tip 10 has a curvature, that is, there is a certain angle between the tip 10 and the axis of the stent 20, which is beneficial to the guiding and conveying of the instrument in the blood vessel and reduces the damage to the blood vessel at the same time.

[0039] In some embodiments, please continue to refer to Figure 1 , the stent 20 is woven from a visible nickel-titanium wire, so that the diameter of the stent 20 in the natural state is 85% of the diameter when it is expanded to the maximum extent, and pulling the traction wire 40 can achieve the maximum expansion of the stent 20. In addition, the stent 20 woven from a visible nickel-titanium wire also has the advantages of good compliance, easy transportation, can reach the lesion through tortuous arteries; has a good memory function; is visible, which is convenient for the operator to identify the position of the stent 20; has good biocompatibility and is non-toxic.

[0040] In some embodiments, the wire diameter φ of the developable nitinol wire is 0.05 mm to 0.1 mm. For example, the wire diameter φ of the developable nitinol wire can be 0.05 mm, 0.055 mm, 0.06 mm, 0.065 mm, 0.07 mm, 0.075 mm, 0.08 mm, 0.085 mm, 0.09 mm, 0.095 mm or 0.1 mm. In some embodiments, the stent 20 can be woven from 8-strand, 10-strand, 12-strand or 16-strand developable nitinol wires. The stent 20 of the present invention is woven by combining developable nitinol wires with different wire diameters and strand numbers, and can smoothly pass through microcatheters 01 with smaller diameters (such as 0.021" and 0.017"), and has a wide range of applications.

[0041] In some embodiments, with particular reference to Figures 4a to 4d , the present invention also provides a method for using the intracranial aneurysm neck assisting and shaping integrated device as described above, including the following steps:

[0042] Step 1: After pushing the stent 20 into place, adjust the traction wire 40 so that the outer diameter of the stent 20 meets the surgical requirements, and then lock the locking sleeve 60. At this time, the relative positions of the traction wire 40 and the support wire 70 are fixed, and the outer diameter of the stent 20 also remains fixed.

[0043] Step 2: Fill the aneurysm with coils.

[0044] Step 3: Release the electrolytic detachment area 41. For example, clamp the power supply of the electrolytic detachment device (not shown) on the uncoated surface of the end of the traction wire 40, and energize to disconnect the electrolytic detachment area 41, as Figure 4a shown. At this time, the stent 20 returns to the diameter in its natural state.

[0045] Step 4: Loosen the locking sleeve 60 and withdraw the traction wire 40, as Figure 4b shown.

[0046] Step 5: After the stent 20 is placed in the appropriate position, if the release of the stent 20 is required, the hydrolytic detachment area 31 can be released. For example, advance the microcatheter 01 to the hydrolytic detachment area 31 and inject undiluted contrast agent to disconnect the hydrolytic detachment area 31, as Figure 4c shown. At this time, the stent 20 and the push tube 30 are completely separated, the release of the stent 20 is completed, the coils in the aneurysm are blocked, and the blood flow is guided, as Figure 4d shown.

[0047] By using the above method, the instruments can be disassembled according to the different requirements at each stage of the operation, which is not only convenient for the operator to operate flexibly and quickly, but also improves the safety of the operation.

[0048] In summary, the intracranial aneurysm neck-assisted forming integrated device and its usage method provided by the present invention. The device includes a tip 10, a stent 20, a delivery tube 30, a traction wire 40, a connecting member 50, a locking sleeve 60, and a support wire 70. The tip 10, the stent 20, and the delivery tube 30 are connected in sequence from the distal end to the proximal end. The traction wire 40 passes through the tip 10, the stent 20, and the delivery tube 30 and exits from the delivery tube 30. The support wire 70 is connected to the delivery tube 30 through the connecting member 50. The locking sleeve 60 is sleeved outside the traction wire 40 and the support wire 70 and is used to control the locking or loosening of the traction wire 40 and the support wire 70. There is an electrolytic detachment area 41 between the distal end wire-wound section 21 of the stent 20 and the traction wire 40, and a hydrolytic detachment area 31 between the proximal end wire-wound section 22 of the stent 20 and the delivery tube 30. The device provided by the present invention can pass through a microcatheter 01 with a smaller diameter. Before implanting the coil, it can fully expand the aneurysm orifice, which can not only assist the coil filling but also play a role in guiding blood flow. In addition, the present invention sets the electrolytic detachment area 41 and the hydrolytic detachment area 31, and different detachment methods can be used for detachment according to the disconnection requirements in different stages, improving the safety during the operation.

[0049] Obviously, those skilled in the art can make various modifications and variations to the invention without departing from the spirit and scope of the invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalent technologies, the present invention also intends to include these modifications and variations.

Claims

1. An integrated device for assisting in the formation of the neck of an intracranial aneurysm, characterized in that, It includes a tip, a stent, a delivery tube, a traction wire, a connecting piece, a locking sleeve and a supporting wire. The tip, the stent and the delivery tube are connected in sequence from the distal end to the proximal end. The traction wire passes through the tip, the stent and the delivery tube and exits from the delivery tube. The supporting wire is connected to the delivery tube through the connecting piece. The locking sleeve is sleeved outside the traction wire and the supporting wire and is used to control the locking or loosening of the traction wire and the supporting wire. There is an electrolytic detachment area between the distal end wire-wound section of the stent and the traction wire. Clamp the power supply of the electrolytic detachment device on the uncoated surface of the end of the traction wire and energize to disconnect the electrolytic detachment area. There is a hydrolytic detachment area between the proximal end wire-wound section of the stent and the delivery tube. Advance the microcatheter to the hydrolytic detachment area and inject undiluted contrast agent to disconnect the hydrolytic detachment area.

2. The intracranial aneurysm neck auxiliary forming integrated device according to claim 1, wherein, There are also radiopaque rings sleeved on the distal end wire-wound section and the proximal end wire-wound section of the stent respectively.

3. The intracranial aneurysm neck-assisted shaping integrated device according to claim 1, wherein The tip has a curvature.

4. The intracranial aneurysm neck auxiliary shaping integrated device according to claim 1, wherein, The stent is woven from radiopaque nitinol wire.

5. The intracranial aneurysm neck auxiliary forming integrated device according to claim 4, characterized in that, The wire diameter φ of the radiopaque nitinol wire is from 0.05 mm to 0.1 mm.

6. The intracranial aneurysm neck-assisted shaping integrated device according to claim 5, wherein The wire diameter φ of the radiopaque nitinol wire is 0.05 mm, 0.055 mm, 0.06 mm, 0.065 mm, 0.07 mm, 0.075 mm, 0.08 mm, 0.085 mm, 0.09 mm, 0.095 mm or 0.1 mm.

7. The intracranial aneurysm neck auxiliary shaping integrated device according to claim 4, characterized in that, The stent is woven from 8-strand, 10-strand, 12-strand or 16-strand radiopaque nitinol wire.

8. A method for using an integrated device for intracranial aneurysm neck assisted shaping according to any one of claims 1 to 7, characterized in that, It includes the following steps: Step 1: After pushing the stent into place, adjust the traction wire to make the outer diameter of the stent meet the requirements, and then lock the locking sleeve. Step 2: Fill the aneurysm with a coil. Step 3: Detach the electrolytic detachment area. Clamp the power supply of the electrolytic detachment device on the uncoated surface of the end of the traction wire and energize to disconnect the electrolytic detachment area. Step 4: Loosen the locking sleeve and withdraw the traction wire. Step 5: Detach the hydrolytic detachment area. Advance the microcatheter to the hydrolytic detachment area and inject undiluted contrast agent to disconnect the hydrolytic detachment area.

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