Superimposed net thrombus capturing device

Abstract

The invention relates to the technical field of interventional medical instruments, in particular to a superimposed net thrombus capturing device which comprises elliptical spherical spiral wires, a plurality of supporting rods and a plurality of supporting rods. The elliptical spherical spiral wires comprise thrombus breaking sparse sections and collecting dense sections, and the spiral wire spacing of the thrombus breaking sparse sections is larger than the spiral wire spacing of the collecting dense sections; the far end of the sliding sleeve is connected with the near end of the thrombus breaking dredging section; the near end of the one-way connecting ring is connected with the far end of the collecting dense section; the guide wire is inserted into the sliding sleeve, the elliptical spherical spiral wire and the one-way connecting ring; and the micro-catheter is sleeved outside the sliding sleeve, the elliptical spherical spiral wire and the one-way connecting ring. The thrombus can be clamped by changing the distance, the thrombus fragment intercepting and removing effect is good, machining is easy, and operation is safer.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical devices, and particularly relates to a superposed net thrombus capture device. Background Art

[0002] The recanalization rate of intravenous thrombolytic therapy is relatively low, and endovascular interventional therapy is the most effective recanalization method for acute large vessel occlusion. At present, endovascular thrombus interventional therapy mainly includes the following methods: catheter thrombolysis, mechanical thrombectomy, intravascular ultrasound-assisted therapy, balloon dilation and stent implantation, etc. Among them, mechanical thrombectomy such as thrombus aspiration catheter, thrombectomy stent, etc., directly removes thrombus from the blood vessel, and can recanalize the blood vessel more quickly. This method is especially suitable for acute large vessel occlusive lesions, and can quickly open the blood vessel and save ischemic tissues.

[0003] At present, there are many mechanical thrombectomy products and related technologies. However, the inventor has carefully observed and summarized in long-term clinical work and found that the existing mechanical thrombus capture devices still have the following defects: 1. The thrombus is captured by an interception net with a fixed aperture, and it is difficult for the capture mesh holes to adapt to the size of the cut thrombus block, resulting in low efficiency of thrombus fragmentation and capture, especially difficult to adapt to thrombus with a hard and tough texture; 2. The grid-shaped interception net is not easy to bend, so that the curved part of the blood vessel is easily damaged by the interception net during thrombectomy, and it is not easy to capture thrombus in dead corners such as the bifurcation of the blood vessel; 3. The processing requirements for the grid-shaped interception net are relatively high.

[0004] Therefore, a superposed net thrombus capture device is proposed. Summary of the Invention

[0005] The object of the present invention includes providing a superposed net thrombus capture device that can clamp thrombus, has good interception and clearance effects on thrombus fragments, is easy to process, and is safer to operate.

[0006] In order to achieve the above object, the present invention has the following technical solutions:

[0007] The present invention provides a superposed net thrombus capture device, including:

[0008] An elliptical spherical spiral wire, including a thrombus fragmentation sparse section and a collection dense section, and the spiral wire pitch of the thrombus fragmentation sparse section is greater than the spiral wire pitch of the collection dense section;

[0009] A sliding sleeve, the distal end of which is connected to the proximal end of the thrombus fragmentation sparse section;

[0010] A one-way connection ring, the proximal end of which is connected to the distal end of the collection dense section;

[0011] A guide wire, which is inserted inside the sliding sleeve, the elliptical spherical spiral wire, and the one-way connection ring;

[0012] The microcatheter is sleeved outside the sliding sleeve, the elliptical spherical helical wire, and the one-way connection ring.

[0013] Preferably, the one-way connection ring includes a cylindrical portion and a conical portion with a through hole in the center, and an annular convex portion is provided on the outer peripheral surface at the junction of the conical portion and the cylindrical portion.

[0014] Preferably, a plurality of interconnected inclined surface cavities and tension spring grooves are equidistantly arranged on the peripheral wall of the cylindrical portion. A U-shaped tension spring is connected to the inner surface of the proximal end of the inclined surface cavity or the tension spring groove. The distal end of the U-shaped tension spring is connected to a wedging microsphere. The outer surface of the wedging microsphere contacts the inner surface of the inclined surface cavity. The U-shaped spring is used to pull the wedging microsphere towards its proximal end under the action of its own restoring force, and when the U-shaped spring is extruded by the inner surface of the front part of the microcatheter, it is used to push the wedging microsphere to be limited to the inner surface of the distal end of the inclined surface cavity.

[0015] Preferably, the maximum outer diameter of the thrombus fragmentation and dredging section is equal to the maximum outer diameter of the collection and densification section, and the wire diameter of the thrombus fragmentation and dredging section is smaller than the wire diameter of the collection and densification section.

[0016] Preferably, the elliptical spherical helical wire is a single helix structure.

[0017] Preferably, the maximum outer diameter of the thrombus fragmentation and dredging section is 6 mm.

[0018] Preferably, the gap of the thrombus fragmentation and dredging section is 1 - 2 mm.

[0019] Preferably, the gap of the collection and densification section is 0.01 - 0.05 mm.

[0020] Preferably, the collection and densification section is coated with a thrombus adhesion coating, and the thrombus adhesion coating is any one or a combination of bioorthogonal alkyne-azide copper-free, polydopamine film, DNA interaction agent, amine-functionalized cyclooctyne derivative.

[0021] Preferably, the overlapping mesh thrombus capture device further includes a visualization marker, and the visualization marker is arranged outside the sliding sleeve, the one-way connection ring and the microcatheter. The visualization marker is made of any one or a combination of gold, platinum-tungsten alloy, platinum-iridium alloy, tantalum.

[0022] Preferably, a plurality of winding wires are connected to the proximal end of the cylindrical portion, and the winding wires are located inside the elliptical spherical helical wire.

[0023] Preferably, the winding wire includes an elastic thin wire whose one end can curl into a ball under the action of its own elastic restoring force and / or bend to contact the inner wall of the elliptical spherical helical wire.

[0024] Preferably, the diameter of the wound wire ranges from 0.001 to 0.01 mm.

[0025] Preferably, the overlapping mesh thrombus capture device further includes a suction catheter, and the suction catheter is movably inserted outside the sliding sleeve.

[0026] Preferably, the distal end of the suction catheter is provided with threads matching the spiral wire of the thrombus fragmentation section.

[0027] Preferably, the axial length of the elliptical spherical spiral wire in the non-compressed state ranges from 10 to 60 mm, more preferably from 15 to 30 mm; the maximum radial diameter of the elliptical spherical spiral wire in the non-compressed state ranges from 2 to 6 mm, more preferably from 3 to 5 mm.

[0028] Preferably, the elliptical spherical spiral wire is made of nitinol alloy.

[0029] Due to the above technical solutions, the advantages of the present invention are as follows:

[0030] 1. The elliptical spherical spiral wire for thrombus capture provided by the present invention is a single spiral structure. Compared with other thrombus capture structures such as staggered meshes, it is easier to bend and fit along the shape of the blood vessel. Compared with stent-type thrombus removal devices, it is beneficial to reduce the friction between the device and the inner wall of the blood vessel during the operation, avoid blood vessel displacement and intimal injury, and has higher safety during the operation in the distal blood vessel, and is more suitable for thrombus capture in dead ends such as blood vessel bifurcations.

[0031] 2. The elliptical spherical spiral wire provided by the present invention not only has a collection dense section, but also after the microcatheter is removed, several wound wires are wound and bent under the action of their own elastic restoring force, and further block inside the collection dense section, realizing the full interception of thrombus fragments by the collection dense section. Under the tension of the guide wire, the collection dense section is further compressed and the gap is reduced, which can further improve the interception effect of the collection dense section on thrombus fragments. In addition, the suction catheter further realizes the suction and clearance of thrombus fragments, reducing or avoiding the escape of thrombus fragments. Therefore, without multi-stage interception means, it is still possible to effectively intercept and remove thrombus fragments.

[0032] 3. When the microcatheter is not removed, the inner wall of the microcatheter squeezes the J-shaped tension spring, causing the J-shaped tension spring to push the wedge-shaped ball connected to its distal end to be clamped in the hook groove on the inner surface of the distal end of the inclined surface cavity (the wedge-shaped microball does not contact the guide wire), so that the guide wire can first enter the distal end of the thrombus to be removed, and then the one-way connection ring is sleeved on the guide wire and pushed forward until the entire capture area moves along the guide wire through the thrombus to be removed, realizing that the capture part can be placed in place under the guidance of the guide wire, reducing the placement difficulty and avoiding blood vessel injury.

[0033] 4. The distal end of the collecting dense section of the ellipsoidal spherical spiral wire provided by the present invention is connected to the proximal end of the one-way connecting ring. After the capture area is placed in place and the microcatheter is pulled out, the microcatheter no longer compresses the several-shaped tension spring. The several-shaped tension spring contracts to pull the wedging microball to between the inclined surface of the inclined surface cavity and the guide wire, so that when the guide wire is pulled toward the proximal end, the wedging microball wedges the one-way connecting ring and the guide wire together, so that the guide wire can pull the collecting dense section toward the proximal end by pulling the one-way connecting ring, and the ellipsoidal spherical spiral wire is compressed, so that the gap of the ellipsoidal spherical spiral wire can be reduced and adjusted, thereby increasing the clamping force on the thrombus, which is beneficial to thrombus removal and reduces or avoids the escape of thrombus fragments.

[0034] 5. The proximal end of the thrombus-breaking segment of the ellipsoidal spiral wire provided by the present invention is connected to the distal end of the sliding sleeve, and the thrombus-breaking segment can be driven to move forward and backward by pushing, pulling or rotating the sliding sleeve, and / or rotated left and right to cut and remove the thrombus. At the same time, the distal end of the sliding sleeve is combined with the limiting of the proximal end of the thrombus-breaking segment, and the ellipsoidal spiral wire is controlled to be compressed by pulling the guide wire, thereby increasing the clamping force on the thrombus, thereby having a strong capture force on the thrombus that is tough and tightly adhered to the blood vessel wall.

[0035] 6. The proximal end of the sparse plug-breaking section of the elliptical spherical spiral wire provided by the present invention is connected to the distal end of the sliding sleeve, and the distal end of the dense collecting section of the elliptical spherical spiral wire is connected to the proximal end of the one-way connecting ring. The one-way connecting ring can be movably or transmission-connected to the guide wire, so twisting the sliding sleeve can complete the adjustment of the radial length of the elliptical spherical spiral wire, which is helpful to accurately control the radial supporting force.

[0036] 7. The present invention does not require cutting to manufacture a number of complex capture grid units of specific structures. The main body is a simple single spiral structure and is easy to process and manufacture. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments are 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 creative work.

[0038] Figure 1 An axial cross-sectional schematic diagram of Example 1 of the overlapping mesh thrombus capturing device provided by the present invention;

[0039] Figure 2 for Figure 1 A is an enlarged schematic diagram;

[0040] Figure 3 For the general Figure 1 Schematic diagram of the state after the microcatheter is removed;

[0041] Figure 4 Schematic diagram of the state after removing the wound wire in Figure 3 ;

[0042] Figure 5 Axial sectional view of Embodiment 2 of the superposed net thrombus capture device provided by the present invention;

[0043] Figure 6 Schematic diagram of the state after removing the microcatheter in Figure 5 ;

[0044] In the figure: 1, guide wire; 2, sliding sleeve; 3, one-way connecting ring; 31, annular convex part; 32, wedging ball; 33, inclined plane cavity; 34, U-shaped tension spring; 35, tension spring groove; 4, wound wire; 5, microcatheter; 6, aspiration catheter; 61, thread; 7, radiographic marker; 10, ellipsoidal spiral wire; 11, thrombus fragmentation section; 12, collection dense section. Detailed implementation manners

[0045] In the description of the present invention, it should be noted that if terms such as "upper", "lower", "inner", "outer", "left", "right", "front", "rear", etc. are used to indicate the orientation or positional relationship, it is based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of the present invention is usually placed during use. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention.

[0046] In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features.

[0047] It should be noted that, without conflict, the features in the embodiments of the present invention can be combined with each other.

[0048] The detailed implementation manners are described as follows:

[0049] Embodiment 1 of the superposed net thrombus capture device provided by the present invention, see Figure 1 , Figure 3 , including:

[0050] An ellipsoidal spiral wire 10, including a thrombus fragmentation section 11 and a collection dense section 12, the spiral wire pitch of the thrombus fragmentation section 11 is greater than the spiral wire pitch of the collection dense section 12, the maximum outer diameter of the thrombus fragmentation section 11 is equal to the maximum outer diameter of the collection dense section 12, and the wire diameter of the thrombus fragmentation section 11 is smaller than the wire diameter of the collection dense section 12, see Figure 1 , Figure 4 ;

[0051] The sliding sleeve 2 has its distal end welded to the proximal end of the thrombus-breaking and dredging section 11;

[0052] The one-way connection ring 3 includes a cylindrical part and a conical part with a through hole in the center, and an annular convex part 31 is provided on the outer peripheral surface at the junction of the conical part and the cylindrical part. Four communicating inclined plane cavities 33 and spring grooves 35 are equidistantly arranged on the peripheral wall of the cylindrical part. A J-shaped spring 34 is connected to the inner surface of the proximal end of the inclined plane cavity 33 or the spring groove 35. The distal end of the J-shaped spring 34 is connected to a wedging microsphere 32. The outer surface of the wedging microsphere 32 contacts the inner surface of the inclined plane cavity 33. The proximal end of the cylindrical part is welded to the distal end of the collection dense section 12. See Figure 2 ;

[0053] Several winding wires 4 have one end uniformly welded to the proximal end of the cylindrical part and are located inside the elliptical spherical spiral wire 10;

[0054] The guide wire 1 is inserted inside the sliding sleeve 2, the elliptical spherical spiral wire 10, and the one-way connection ring 3;

[0055] The microcatheter 5 is sleeved outside the sliding sleeve 2, the elliptical spherical spiral wire 10, and the one-way connection ring 3. See Figure 1 、 Figure 2 ;

[0056] The imaging marker 7 is provided on the outer surfaces of the sliding sleeve 2, the one-way connection ring 3, and the microcatheter 5.

[0057] In this embodiment, the elliptical spherical spiral wire 10 is a single spiral structure made of nitinol alloy; the collection dense section 12 is coated with a thrombus adhesion coating. The wire diameter of the collection dense section 12 is 0.04 - 0.08 mm, the gap is 0.01 - 0.05 mm, and the maximum outer diameter is 6 mm; the wire diameter of the thrombus-breaking and dredging section 11 is 0.02 - 0.06 mm, and the gap is 1 - 2 mm; the winding wire is made of nitinol alloy, and the diameter range is 0.001 - 0.01 mm. The specific dimensional parameters of the remaining conventional components such as the guide wire 1 and the microcatheter 5 are selected according to the conventional parameters of the prior art and will not be elaborated here.

[0058] Embodiment 2 of the superposed net thrombus capture device provided by the present invention. See Figure 5 、 Figure 6 On the basis of the above Embodiment 1, it further includes a suction catheter 6. The distal port of the suction catheter 6 is provided with a thread 61 matching the spiral wire of the thrombus-breaking and dredging section 11, and the suction catheter 6 is movably inserted outside the microcatheter 5.

[0059] In this embodiment, the inner diameter of the suction catheter 6 is equal to the maximum outer diameter of the thrombus-breaking and dredging section 11.

[0060] Usage method of the present invention:

[0061] S1. Detect the condition of the thrombus in the blood vessel and make preparations;

[0062] S2. Perform percutaneous puncture outside the body and push the distal end of the guide wire 1 through the thrombus target area;

[0063] S3. Hold the present invention and insert the distal end of the one-way connection ring 3 over the proximal end of the guide wire 1, and continue to advance until the imaging marker 7 on the microcatheter 5 is located at the distal end of the thrombus target area;

[0064] S4. Withdraw the microcatheter 5 to gradually release the thrombus capture device in situ (when the thrombus is a soft thrombus, the elliptical spherical spiral wire 10 can easily expand and open itself in the blood vessel, and embed the soft thrombus into the thrombus fragmentation section 11 of the elliptical spherical spiral wire 10. During this process, small thrombi that may be generated will be intercepted by the collection section 12; when the thrombus is a hard thrombus, after the elliptical spherical spiral wire 10 is released in situ, the thrombus fragmentation section 11 cannot fully open and embed the thrombus. At this time, the sliding sleeve 2 can be withdrawn and reset with a small amplitude and relatively quickly to further expand the gap between the wires of the thrombus fragmentation section 11 until the large hard thrombus completely falls into the thrombus fragmentation section 11; when the sliding sleeve 2 is stationary and the guide wire 1 is withdrawn, the collection section 12 can be compressed by pulling the one-way connection ring 3 back through the guide wire 1, and the gap between the wires of the collection section 12 decreases);

[0065] S5. Pull the guide wire 1 while pulling back and / or appropriately rotate the sliding sleeve 2 to cut and collect the target thrombus;

[0066] S6. Continue to pull back the sliding sleeve 2 and the guide wire 1 until the present invention is withdrawn from the human body as a whole.

[0067] After the microcatheter 5 is withdrawn, an aspiration catheter 6 can also be inserted over the sliding sleeve 2 from the proximal end of the sliding sleeve 2 and pushed until the distal end of the aspiration catheter 6 contacts the proximal end of the target area thrombus. Then, while aspirating, the sliding sleeve 2 and the guide wire 1 can be withdrawn until the elliptical spherical spiral wire 10 completely enters the aspiration catheter 6. Finally, continue to withdraw the sliding sleeve 2, the guide wire 1 and the aspiration catheter 6 until the present invention is withdrawn from the human body as a whole.

[0068] The above embodiments of the present invention are merely examples for clearly illustrating the present invention, rather than limiting the implementation manners of the present invention. For those of ordinary skill in the art, other different forms of changes or modifications can be made based on the above description. It is impossible to list all the implementation manners here. Any obvious changes or modifications derived from the technical solutions of the present invention still fall within the protection scope of the present invention.

Claims

1. A superimposed mesh thrombus capture device, characterized in that, Comprising: An elliptical spherical helical wire (10), including a thrombus-breaking sparse section (11) and a collection dense section (12), the helical wire pitch of the thrombus-breaking sparse section (11) being greater than the helical wire pitch of the collection dense section (12); A sliding sleeve (2), the distal end being connected to the proximal end of the thrombus-breaking sparse section (11); A one-way connection ring (3), the proximal end being connected to the distal end of the collection dense section (12); A guide wire (1), inserted inside the sliding sleeve (2), the elliptical spherical helical wire (10), and the one-way connection ring (3); A microcatheter (5), sleeved outside the sliding sleeve (2), the elliptical spherical helical wire (10), and the one-way connection ring (3).

2. The overlapping net thrombus capture device according to claim 1, wherein: The one-way connection ring (3) includes a cylindrical part and a conical part with a through hole in the center, and an annular convex part (31) is provided on the outer peripheral surface at the junction of the conical part and the cylindrical part.

3. The overlapping net thrombus capture device according to claim 2, wherein: A plurality of interconnected inclined surface cavities (33) and spring grooves (35) are equidistantly arranged on the peripheral wall of the cylindrical part. A J-shaped spring (34) is connected to the inner surface of the proximal end of the inclined surface cavity (33) or the spring groove (35). The distal end of the J-shaped spring (34) is connected to a wedging microsphere (32), and the outer surface of the wedging microsphere (32) contacts the inner surface of the inclined surface cavity (33).

4. The overlapping network thrombus capture device according to claim 1, wherein: The maximum outer diameter of the thrombus-breaking sparse section (11) is equal to the maximum outer diameter of the collection dense section (12), and the wire diameter of the thrombus-breaking sparse section (11) is smaller than the wire diameter of the collection dense section (12).

5. The overlapping net thrombus capture device according to claim 1, characterized in that: The elliptical spherical helical wire (10) is a single helix structure.

6. The overlapping net thrombus capture device according to claim 1, wherein: It further includes a radiopaque marker (7), and the radiopaque marker (7) is provided on the outer surfaces of the sliding sleeve (2), the one-way connection ring (3), and the microcatheter (5).

7. The overlapping net thrombus capture device according to claim 2, wherein: A plurality of winding wires (4) are connected to the proximal end of the cylindrical part.

8. The overlapping net thrombus capture device according to claim 7, wherein: The winding wire (4) includes an elastic thin wire whose one end can curl into a ball under the action of its own elastic restoring force and / or bend.

9. The overlapping network thrombus capture device according to claim 1, characterized in that: It further includes a suction catheter (6), and the suction catheter (6) is movably inserted outside the sliding sleeve (2).

10. The overlapping mesh thrombus capture device according to claim 9, characterized in that: A thread (61) is provided at the distal port of the suction catheter (6).

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