Peristaltic thrombus breaking and moving suction catheter and use method thereof

Abstract

The invention discloses a peristaltic thrombus breaking and moving suction catheter and a using method thereof, and relates to the technical field of interventional medical instruments.The peristaltic thrombus breaking and moving suction catheter comprises a catheter body, the catheter body comprises a suction channel and an adjusting channel, and the adjusting channel is adjacent to the suction channel; the adjusting channel is provided with the peristaltic structure, the peristaltic structure comprises a plurality of adjusting sections arranged in the axial direction of the catheter body, the expansion degree between the two ends of each adjusting section is adjustable, during thrombus aspiration, the intermittent adjusting sections extrude the aspiration channel during expansion, and the parts, with the maximum expansion degree, of every two adjacent adjusting sections are not adjacent; the adjusting section enables part of the channel wall of the suction channel to be provided with a corrugated structure in the axial direction. And when the expansion degree of the adjusting section is adjusted every time, the positions, with the maximum expansion degree, of the adjusting section are different, so that the channel wall of the suction channel forms dynamic corrugated movement (namely similar to gastrointestinal peristalsis surface movement), and the thrombus carrying power is enhanced.

Description

Technical Field

[0001] The present application relates to the technical field of interventional medical devices, and in particular to a peristaltic thrombus-breaking and thrombus-moving aspiration catheter and a method of using the same. Background Art

[0002] ADAPT (A Direct Aspiration first-Pass Technology, ADAPT) is an intravascular treatment method that uses direct aspiration as a thrombectomy technique. The main advantages of ADAPT are that the technical operation is simpler, the opening time is short, the bleeding rate is low, the safety is relatively high, the proportion of third-level recanalization is increased, and the number of distal embolic escape events is reduced. However, its biggest disadvantage is that some cases cannot be in place or the thrombus is difficult to aspirate due to vascular stenosis. In the case of vascular stenosis or complex lesions, the thrombus may be difficult to be effectively aspirated, thereby reducing the effectiveness of the technology. Some large hard thrombi are prone to blockage and tube jam in the blood vessels, thus affecting the recanalization of the blood vessels. Extracorporeal cannulation or multiple tube changes are required. After the tube jam has occurred, the operation of removing the catheter from the human body is extremely complicated, and the thrombus is prone to distal escape. During the process, the operator needs to be more careful to avoid more unnecessary risks caused by tube jam. Summary of the invention

[0003] The present application aims to solve one of the above-mentioned technical problems in the prior art. To this end, the present application provides a peristaltic thrombus-breaking and thrombus-moving suction catheter.

[0004] The embodiment of the present application also provides a method for using a peristaltic thrombus-breaking and thrombus-moving suction catheter.

[0005] According to an embodiment of the first aspect of the present application, a peristaltic thrombus-breaking and thrombus-moving suction catheter is provided, comprising a catheter body, the catheter body comprising a suction channel and an adjustment channel, the adjustment channel being adjacent to the suction channel; a peristaltic structure, at least a portion of the adjustment channel being provided with the peristaltic structure, the peristaltic structure comprising a plurality of adjustment segments arranged along the axial direction of the catheter body, the expansion degree between the two ends of the adjustment segment being adjustable, the adjustment segment compressing the suction channel when expanded, the portions of two adjacent adjustment segments with the largest expansion degrees being not adjacent, and the adjustment segment causing a portion of the channel wall of the suction channel to have a corrugated structure along the axial direction.

[0006] The above-mentioned peristaltic thrombus-breaking and thrombus-moving suction catheter has at least the following beneficial effects: an adjustment channel is provided in the catheter body, and a peristaltic structure is provided in part or all of the adjustment channel, the peristaltic structure adjusts the local width of the suction pipe through a plurality of adjustment sections with adjustable expansion, and during the suction operation of thrombus, the expansion degree of the adjustment section is intermittently adjusted, and the parts with the largest expansion degree of two adjacent adjustment sections are not adjacent, so that part of the channel wall of the suction channel has a corrugated structure along the axial direction, and each time the expansion degree of the adjustment section is adjusted, the position with the largest expansion degree of the adjustment section is different, so that the channel wall of the suction channel forms a dynamic corrugated movement (that is, similar to the surface movement of gastrointestinal "peristalsis"), thereby enhancing the thrombus transportation power; in addition, during the process of thrombus suction, for large and irregularly shaped thrombi, the part of the adjustment section with the largest expansion degree during the peristaltic process will squeeze the thrombus, causing the thrombus to break or deform, thereby avoiding tube jamming.

[0007] According to the peristaltic thrombus breaking and removing suction catheter described in the embodiment of the first aspect of the present application, the catheter body includes an outer tube layer, an adjustment channel and a suction channel for aspirating thrombus, and the adjustment channel is adjacent to the outer tube layer; a peristaltic structure, at least a portion of the adjustment channel is provided with the peristaltic structure, and the peristaltic structure includes a plurality of adjustment segments arranged along the axial direction of the catheter body, the expansion degree between the two ends of the adjustment segment is adjustable, and the adjustment segment adjusts the surface shape of the outer tube layer when expanded, and the portions with the largest expansion degrees of two adjacent adjustment segments are not adjacent, and the adjustment segment causes a portion of the surface of the outer tube layer to have a corrugated structure along the axial direction.

[0008] The above-mentioned peristaltic thrombus-breaking and thrombus-moving suction catheter has at least the following beneficial effects: an adjustment channel is set at a position of the catheter body close to the outer tube layer, and a peristaltic structure is set in part or all of the adjustment channel. The peristaltic structure adjusts the surface shape of the outer tube layer through multiple adjustment segments with adjustable expansion. During the movement of the catheter body in the blood vessel, the expansion of the adjustment segment is intermittently adjusted, and the maximum expansion portions of two adjacent adjustment segments are not adjacent, so that part of the surface of the outer tube layer has a corrugated structure along the axial direction, and each time the expansion of the adjustment segment is adjusted, the position of the maximum expansion of the adjustment segment is different (that is, the position of the maximum expansion is changed each time the expansion is adjusted), so that the channel wall of the suction channel forms a dynamic corrugated movement (that is, similar to the surface movement of the gastrointestinal "peristalsis"). For the suction of distal intracranial thrombus, it will go through long, far, complex and tortuous blood vessels. After the conventional suction catheter is in place, there will be a certain tension. After the suction operation is performed, the tension between the catheter and the blood vessel will increase, and some catheters may be difficult to withdraw. The catheter body of the present application is additionally provided with a peristaltic structure. During the use process before being in place, the peristaltic reciprocating motion of the surface of the outer tube layer will eliminate part of the tension, thereby avoiding increasing the tension of the catheter body or increasing the risk of catheter withdrawal.

[0009] According to the peristaltic thrombus-breaking and thrombus-moving suction catheter described in the first aspect of the present application, the adjustment section includes at least two expansion tubes, the expansion tubes are annular, the suction channel passes through the expansion tubes, and the expansion tubes at the same position of all the adjustment sections are connected.

[0010] According to the peristaltic thrombus-breaking and thrombus-removing suction catheter described in the first embodiment of the present application, it is assumed that the diameter of the expansion tube is D, and the center distance between two adjacent expansion tubes is greater than or equal to 1.5D.

[0011] According to the peristaltic thrombus-breaking and thrombus-removing suction catheter described in the first aspect of the present application, let the number of the expansion tubes be N. When the number of the expansion tubes exceeds 2, N is a multiple of 2. Let the number of the expansion tubes between the expansion tube with the largest expansion degree and the expansion tube with the lowest expansion degree be n, and n=(N-2) / 2.

[0012] According to the peristaltic thrombus-breaking and thrombus-removing suction catheter described in the first aspect of the present application, the number of the expansion tubes is at least 4, and the expansion degrees of the expansion tubes gradually decrease from the expansion tube with the largest expansion degree to the expansion tube with the lowest expansion degree.

[0013] According to the peristaltic thrombus-breaking and thrombus-moving suction catheter described in the first aspect of the present application, in the adjustment section, only one expansion tube has the largest expansion degree, and each time the adjustment section performs an expansion degree adjustment, the position of the expansion tube with the largest expansion degree changes once.

[0014] According to the peristaltic thrombus-breaking and thrombus-removing suction catheter described in the first aspect of the present application, the position of the expansion tube with the largest expansion degree is changed toward the proximal direction of the catheter body, and the position of the expansion tube with the largest expansion degree is changed in such a way that the expansion degree of the expansion tube adjacent to the expansion tube with the largest expansion degree last time becomes the largest.

[0015] According to the peristaltic thrombus-breaking and thrombus-removing suction catheter described in the first aspect of the present application, the position of the expansion tube with the largest expansion degree is changed toward the distal direction of the catheter body, and the position of the expansion tube with the largest expansion degree is changed in such a way that the expansion degree of the expansion tube adjacent to the expansion tube with the largest expansion degree last time becomes the largest.

[0016] According to an embodiment of the second aspect of the present application, a method for using a peristaltic thrombus-breaking and thrombus-moving aspiration catheter is provided, comprising the following steps:

[0017] Select a catheter body that matches the diameter of the blood vessel;

[0018] Delivering the catheter body equipped with the peristaltic structure to the lesion site of the target blood vessel through an arterial access route;

[0019] The external device for providing suction force starts the suction work, provides negative pressure suction force for the catheter body, and the thrombus enters the catheter body under the action of the negative pressure suction force, and then is drawn out of the blood vessel through the catheter body;

[0020] The external device providing suction force stops the suction work, and the catheter body is withdrawn from the human body;

[0021] Wherein, if the peristaltic structure is close to the inner layer of the catheter body, a flow medium is injected into the expansion tube during the suction process of the catheter body to adjust the expansion degree of the expansion tube, and each time the adjustment section adjusts the expansion degree, the position of the expansion tube with the largest expansion degree is changed once;

[0022] If the peristaltic structure is close to the outer layer of the catheter body, the catheter body injects flow medium into the expansion tube to adjust the expansion degree of the expansion tube during the pushing and pulling process in the blood vessel. Each time the adjustment section adjusts the expansion degree, the position of the expansion tube with the largest expansion degree changes once.

[0023] Additional aspects and advantages of the present application will be given in part in the description below, and in part will become apparent from the description below, or will be learned through the practice of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The present application is further described below with reference to the accompanying drawings and embodiments;

[0025] Figure 1is a schematic diagram of the structure of the suction catheter in an embodiment of the present application;

[0026] Figure 2 yes Figure 1 The enlarged schematic diagram of point A in the middle;

[0027] Figure 3 yes Figure 1 The cross-sectional view along the BB direction;

[0028] Figure 4 This is a schematic diagram of the creeping structure in the embodiment of the present application. Figure 1 ;

[0029] Figure 5 This is a schematic diagram of the creeping structure in the embodiment of the present application. Figure 2 ;

[0030] Figure 6 This is a schematic diagram of the creeping structure in the embodiment of the present application. Figure 3 ;

[0031] Figure 7 This is a schematic diagram of the creeping structure in the embodiment of the present application. Figure 4 ;

[0032] Figure 8 This is a schematic diagram of the catheter body being pulled out of the blood vessel in the embodiment of the present application. Figure 1 ;

[0033] Fig. 9 This is a schematic diagram of the catheter body being pulled out of the blood vessel in the embodiment of the present application. Figure 2 ;

[0034] Fig.10 This is a schematic diagram of the catheter body being pulled out of the blood vessel in the embodiment of the present application. Figure 3 .

[0035] Reference numerals:

[0036] Catheter seat 100, catheter body 200, suction channel 201, developing ring 202, hydrophilic coating 210, outer tube layer 220, braided layer 230, spring winding layer 240, adjustment channel 250, first expansion tube 251, third expansion tube 2521, fourth expansion tube 2522, second expansion tube 253, inner lining layer 260. DETAILED DESCRIPTION

[0037] This section will describe in detail the specific embodiments of the present application. The preferred embodiments of the present application are shown in the accompanying drawings. The purpose of the accompanying drawings is to supplement the description of the text part of the specification with graphics, so that people can intuitively and vividly understand each technical feature and the overall technical solution of the present application, but it cannot be understood as a limitation on the scope of protection of the present application.

[0038] In the description of the present application, it should be understood that descriptions involving orientation, such as up, down, front, back, left, right, etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present application.

[0039] In the description of this application, "several" means one or more, "more" means more than two, "greater than", "less than", "exceed", etc. are understood to exclude the number itself, and "above", "below", "within", etc. are understood to include the number itself. If there is a description of "first" or "second", it is only used for the purpose of distinguishing technical features, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features or implicitly indicating the order of the indicated technical features.

[0040] In the description of this application, unless otherwise clearly defined, terms such as setting, installing, connecting, etc. should be understood in a broad sense, and technicians in the relevant technical field can reasonably determine the specific meanings of the above terms in this application based on the specific content of the technical solution.

[0041] In order to describe the present invention more clearly, the meanings of the two concepts of "distal end" and "proximal end" are defined here. The above concepts are commonly used terms in the field of interventional medical devices. Specifically, the "distal end" refers to the end away from the operator during the operation, and the "proximal end" refers to the end close to the operator during the operation. Of course, for a single device object, the "proximal end" can also be described as the end close to the operator, and the "distal end" can also be described as the end away from the operator.

[0042] Thromboaspiration is an interventional treatment method that uses a catheter inserted into a blood vessel to extract the thrombus using a special device to restore blood flow. This technology is mainly used to treat thrombotic diseases such as acute coronary syndrome and cerebral infarction.

[0043] The principle of thrombus aspiration is to use a special catheter to cut or extract the thrombus, so that the blood vessel is unobstructed and blood flow returns to normal. The catheter is inserted into the blood vessel, and after positioning in the appropriate position, the instrument for cutting or sucking out the thrombus is sent into the blood vessel. These instruments usually include special catheters and suction tubes, as well as instruments that can penetrate and grab the thrombus. Under the operation of the instrument, the thrombus is separated, captured and sucked out of the body, so that blood flow returns to normal.

[0044] ADAPT (A Direct Aspiration first-Pass Technology, ADAPT) is an intravascular treatment method that uses direct aspiration as a thrombectomy technique. This technology requires the use of a traceable, large-caliber aspiration catheter for direct aspiration and thrombectomy. In 2015, the publication of five major clinical trials on intravascular treatment of stroke confirmed that stroke patients caused by acute large artery occlusion can benefit from intravascular treatment. This milestone progress formally established the first-line treatment status of mechanical thrombectomy in large vessel occlusion, marking the arrival of the thrombectomy era.

[0045] In the past two years, with the emergence of ADAPT technology, stent thrombectomy or catheter aspiration has become a hot topic widely discussed in clinical practice. The 2019 AHA / ASA guideline update listed ADAPT technology as a Class IB recommended therapy, providing strong evidence support for the application of ADAPT technology in clinical practice.

[0046] However, the biggest disadvantage of ADAPT technology is that some cases cannot be performed in place or the thrombus is difficult to aspirate due to vascular stenosis. In the case of vascular stenosis or complex lesions, the thrombus may be difficult to be effectively aspirated, thereby reducing the effectiveness of the technology. Some large hard thrombi are prone to blockage in the blood vessels and cause tube jamming, thus affecting vascular recanalization.

[0047] To this end, an embodiment of the present application provides a peristaltic thrombus-breaking and thrombus-moving aspiration catheter, which can effectively solve the problem of thrombus blocking the tube or making aspiration difficult.

[0048] Reference Figure 1 The peristaltic thrombus-breaking and thrombus-moving suction catheter of the first embodiment of the present application includes a catheter body 200 and a peristaltic structure. The catheter body 200 includes a suction channel 201 and an adjustment channel 250. The adjustment channel 250 is adjacent to the suction channel 201. At least part of the adjustment channel 250 is provided with a peristaltic structure. The peristaltic structure includes a plurality of adjustment segments arranged along the axial direction of the catheter body 200. The expansion degree between the two ends of the adjustment segment is adjustable. When the adjustment segment expands, it squeezes the suction channel 201. The portions of the adjacent two adjustment segments with the largest expansion degrees are not adjacent. The adjustment segment makes part of the channel wall of the suction channel 201 have a corrugated structure along the axial direction.

[0049] The corrugated structure is composed of convex parts and concave parts that appear continuously and alternately on the inner wall of the catheter body 200 .

[0050] The peristaltic structure adjusts the local width of the suction pipe through multiple adjustment sections with adjustable expansion degree. During the suction operation of thrombus, the expansion degree of the adjustment section is adjusted intermittently, and the adjustment frequency of the adjustment section can be the same as the suction frequency.

[0051] The expansion degree of all the adjustment segments is adjusted simultaneously. After the expansion degree is adjusted, the parts with the largest expansion degree of two adjacent adjustment segments are not adjacent, so that part of the channel wall of the suction channel 201 has a corrugated structure along the axial direction, and each time the expansion degree of the adjustment segment is adjusted, the position of the maximum expansion degree of the adjustment segment is different, so that the channel wall of the suction channel 201 forms a dynamic corrugated movement (that is, similar to the surface movement of gastrointestinal "peristalsis"), thereby enhancing the power of transporting thrombus; in addition, during the process of thrombus suction, for large and irregularly shaped thrombus, the part of the adjustment segment with the largest expansion degree during the peristalsis process will squeeze the thrombus, causing the thrombus to break or deform, thereby avoiding tube jamming.

[0052] In some embodiments, the peristaltic thrombus fragmentation and thrombus removal aspiration catheter also includes a stress relief tube and a catheter seat 100. The stress relief tube is sleeved on the proximal end of the catheter body 200, and the stress relief tube is connected to the catheter seat 100. The stress relief tube is used to facilitate the operator's control of the catheter body 200 during the operation to avoid stress concentration and the catheter body 200 from breaking.

[0053] Among them, Figure 3 As shown, the catheter body 200 includes a suction channel 201, an inner lining layer 260, an adjustment channel 250, a spring layer 240, a braided layer 230 and an outer tube layer 220 from the inside to the outside, that is, the suction channel 201 and the adjustment channel 250 are separated by the inner lining layer 260.

[0054] The inner lining layer 260 is made of PTFE material, and a smooth and lubricating suction channel 201 is established through the inner lining layer 260, which is convenient for other instruments to pass through.

[0055] The regulating channel 250 consists of TPU.

[0056] The outer tube layer 220 is composed of TPU and Pebax, and the outer layer contains barium sulfate material that can be developed under radiation. The outer tube layer 220 changes from soft to hard from the distal end to the proximal end, with a stronger hardness change. The distal end remains soft and in place, while the proximal end provides higher support.

[0057] like Figure 2 As shown, a developing ring 202 is provided at the distal end of the catheter body 200. The developing ring 202 is made of a platinum-iridium alloy and can be developed under radiation.

[0058] The spring layer 240 and the braided layer 230 are formed by winding or braiding stainless steel wires. The spring wires and braided wires include but are not limited to original round wires, flat wires, and round and flat mixed / mixed braids. The spring layer 240 and the braided layer 230 are used to strengthen the catheter body structure. The spring pitch and braiding density can be changed from the distal end to the proximal end to achieve better soft and hard performance.

[0059] In some specific embodiments, the effective length of the catheter body 200 is 110-150 cm, the length of the distal soft part of the catheter body 200 is set to 10-30 cm, the length of the hydrophilic coating 210 on the surface of the outer tube layer 220 of the catheter body 200 is 50 to 80 cm, the diameter of the suction channel 201 is 1.0 to 2.5 mm, and the outer diameter of the catheter body 200 is 1.2 to 3.3 mm.

[0060] In some examples, the adjustment section includes at least two expansion tubes, the expansion tubes are annular, the suction channel 201 passes through the expansion tubes, and the expansion tubes at the same position of all the adjustment sections are connected.

[0061] like Figure 4 As shown, in some embodiments shown in the first aspect of the present application, the adjusting section includes a first expansion tube 251 and a second expansion tube 253, the first expansion tubes 251 of all the adjusting sections are connected, the second expansion tubes 253 of all the adjusting sections are connected, and the first expansion tubes 251 and the second expansion tubes 253 are sleeved outside the suction channel 201.

[0062] In some embodiments, the expansion degree of the first expansion tube 251 and the second expansion tube 253 can be adjusted by positive and negative pressure, and the first expansion tube 251 or the second expansion tube 253 is connected to the variable frequency negative pressure suction device. The intermittent frequency conversion of positive and negative pressure makes the first expansion tube 251 and the second expansion tube 253 alternately filled and deflated, and the alternating process forms a dynamic ripple curve on the channel wall surface of the suction channel 201, forming a surface movement similar to the "peristalsis" of the stomach and intestines, thereby enhancing the thrombus transport capacity.

[0063] When positive pressure is applied to the first expansion tube 251, negative pressure is applied to the second expansion tube 253; when negative pressure is applied to the first expansion tube 251, positive pressure is applied to the second expansion tube 253; each time the expansion degree is adjusted, the position of the maximum expansion degree of the adjustment section will change, that is, the first expansion tube 251 and the second expansion tube 253 will alternately become the expansion tubes with the maximum expansion degree, thereby achieving peristaltic squeezing of the thrombus in the suction channel 201 to prevent the thrombus from getting stuck in the tube.

[0064] During the peristaltic extrusion and aspiration of thrombus, for large and irregularly shaped thrombus, the expansion tube of the positive pressure part during the peristaltic process will squeeze the thrombus, causing the thrombus to break or deform. The maximum size of the squeezed thrombus monomer is smaller than the inner diameter of the catheter body 200, avoiding tube jamming.

[0065] In some embodiments, a flowable medium may be introduced into the first expansion tube 251 and the second expansion tube 253 to adjust the expansion degree of the expansion tubes. The filling and deflation of the expansion tubes may be achieved by increasing or decreasing the medium in the expansion tubes. The medium may be a flowable fluid such as water or gas.

[0066] In this embodiment, when the catheter body 200 is performing suction thrombectomy, negative pressure suction (syringe or negative pressure suction pump) is still used as the main means of thrombus suction, and the peristaltic type of the suction channel 201 is embodied as an auxiliary function to prevent tube sticking and enhance the thrombus suction speed.

[0067] In some embodiments, the diameter of the expansion tube is D, and the center distance between two adjacent expansion tubes is greater than or equal to 1.5D. If two expansion tubes are directly close to each other, it is not conducive to the expansion adjustment of the expansion tubes. A certain adjustment gap should be set between the two adjacent expansion tubes, that is, the center distance between the two adjacent expansion tubes should be greater than or equal to 1.5D, so that the corrugated structure formed by the channel wall of the suction channel 201 is more continuous, and sufficient expansion adjustment space can be given to the expansion tube.

[0068] Suppose the number of expansion tubes is N. When the number of expansion tubes exceeds 2, N is a multiple of 2. Suppose the number of expansion tubes between the expansion tube with the largest expansion degree and the expansion tube with the lowest expansion degree is n, n=(N-2) / 2.

[0069] In some embodiments, the number of the expansion tubes is at least 4, and the expansion degrees of the expansion tubes gradually decrease from the expansion tube with the largest expansion degree to the expansion tube with the lowest expansion degree.

[0070] When the number of expansion tubes in each adjustment section is 6, when the expansion degree is adjusted, the number of expansion tubes between the expansion tube with the largest expansion degree and the expansion tube with the lowest expansion degree is 2, and the expansion degree of the expansion tubes between the expansion tube with the largest expansion degree and the expansion tube with the lowest expansion degree gradually decreases.

[0071] In the adjustment section, only one expansion tube has the largest expansion degree. Each time the adjustment section performs an expansion degree adjustment, the position of the expansion tube with the largest expansion degree is changed.

[0072] In some embodiments, the position of the expansion tube with the largest expansion degree changes toward the proximal end of the catheter body 200, and the position of the expansion tube with the largest expansion degree changes in such a way that the expansion degree of the expansion tube adjacent to the expansion tube with the largest expansion degree last time becomes the largest.

[0073] In other embodiments, the position of the expansion tube with the largest expansion degree is changed toward the distal end of the catheter body 200, and the position of the expansion tube with the largest expansion degree is changed in such a way that the expansion degree of the expansion tube adjacent to the expansion tube with the largest expansion degree last time becomes the largest.

[0074] like Figure 5As shown, in some embodiments shown in the first aspect of the present application, the adjustment section includes a first expansion tube 251, a second expansion tube 253, a third expansion tube 2521 and a fourth expansion tube 2522, the third expansion tube 2521 and the fourth expansion tube 2522 are distributed on both sides of the first expansion tube 251, and the third expansion tube 2521 is between the first expansion tube 251 and the second expansion tube 253.

[0075] When the first expansion tube 251 is at its maximum expansion degree, the second expansion tube 253 is at its minimum expansion degree, the third expansion tube 2521 is at a greater expansion degree than the second expansion tube 253, but the third expansion tube 2521 is at a less expansion degree than the first expansion tube 251, the fourth expansion tube 2522 is at a greater expansion degree than the second expansion tube 253, but the fourth expansion tube 2522 is at a less expansion degree than the first expansion tube 251, and the fourth expansion tube 2522 is adjacent to the second expansion tube 253 of the next adjustment section.

[0076] It can be seen that the expansion degrees among the first expansion tube 251, the third expansion tube 2521 and the second expansion tube 253 gradually decrease, that is, the expansion degrees of the expansion tubes from the expansion tube with the largest expansion degree to the expansion tube with the lowest expansion degree gradually decrease.

[0077] When the expansion degree of the next adjustment section is adjusted, the expansion tube with the largest expansion degree changes from the first expansion tube 251 to the third expansion tube 2521, and the fourth expansion tube 2522 has the smallest expansion degree. The expansion degree of the first expansion tube 251 is greater than that of the fourth expansion tube 2522, but the expansion degree of the first expansion tube 251 is less than that of the third expansion tube 2521, but the expansion degree of the second expansion tube 253 is less than that of the third expansion tube 2521, and the fourth expansion tube 2522 is adjacent to the second expansion tube 253 of the next adjustment section.

[0078] At this time, the part with the largest expansion degree in the adjustment section is switched from the first expansion tube 251 to the third expansion tube 2521, and the expansion degree of the adjustment section is intermittently adjusted to realize the peristalsis of the corrugated structure, thereby realizing the formation of a dynamic corrugated curve on the channel wall surface of the suction channel 201, forming a surface movement similar to the "peristalsis" of the stomach and intestines.

[0079] In the second embodiment of the present application, the peristaltic thrombus fragmentation and thrombus removal aspiration catheter includes a catheter body 200 and a peristaltic structure. In this embodiment, the catheter body 200 includes an outer tube layer 220, an adjustment channel 250 and a suction channel 201 for aspirating thrombus. The adjustment channel 250 is adjacent to the outer tube layer 220, and at least a portion of the adjustment channel 250 is provided with a peristaltic structure, that is, the peristaltic structure is adjacent to the outer tube layer 220.

[0080] Among them, the peristaltic structure includes multiple adjustment segments arranged along the axial direction of the catheter body 200, the expansion degree between the two ends of the adjustment segment is adjustable, and the surface shape of the outer tube layer 220 is adjusted when the adjustment segment expands. The parts with the largest expansion degrees of two adjacent adjustment segments are not adjacent, and the adjustment segment makes part of the surface of the outer tube layer 220 have a corrugated structure along the axial direction.

[0081] In the second aspect of the embodiment, an adjustment channel 250 is provided at a position of the catheter body 200 adjacent to the outer tube layer 220, and a peristaltic structure is provided in part or all of the adjustment channel 250. The peristaltic structure adjusts the surface shape of the outer tube layer 220 by means of a plurality of adjustment segments with adjustable expansion. During the movement of the catheter body 200 in the blood vessel, the expansion of the adjustment segments is intermittently adjusted, and the parts with the largest expansion of two adjacent adjustment segments are not adjacent, so that part of the surface of the outer tube layer 220 has a corrugated structure along the axial direction, and each time the expansion of the adjustment segment is adjusted, the position with the largest expansion of the adjustment segment is different (that is, the position with the largest expansion is changed each time the expansion is adjusted), thereby causing the channel wall of the suction channel 201 to form a dynamic corrugated movement (that is, surface movement similar to the "peristalsis" of the gastrointestinal tract).

[0082] Aspiration of distal intracranial thrombus will go through long, far, complex and tortuous blood vessels. Conventional aspiration catheters will have a certain tension after they are in place. After the aspiration operation is performed, the tension between the catheter and the blood vessel will increase, and some catheters may be difficult to withdraw. The catheter body 200 of the present application is equipped with a peristaltic structure. During the use process before it is in place, the surface of the outer tube layer 220 performs a peristaltic reciprocating motion, which will eliminate part of the tension, thereby avoiding increasing the tension of the catheter body 200 or increasing the risk of catheter withdrawal.

[0083] The regulating section includes at least two expansion pipes, which are annular in shape. The suction channel 201 passes through the expansion pipes, and the expansion pipes at the same position of all the regulating sections are connected.

[0084] Assume that the diameter of the expansion tube is D, and the center distance between two adjacent expansion tubes is greater than or equal to 1.5D.

[0085] Suppose the number of expansion tubes is N. When the number of expansion tubes exceeds 2, N is a multiple of 2. Suppose the number of expansion tubes between the expansion tube with the largest expansion degree and the expansion tube with the lowest expansion degree is n, n=(N-2) / 2.

[0086] The number of the expansion tubes is at least 4, and the expansion degrees of the expansion tubes decrease gradually from the expansion tube with the largest expansion degree to the expansion tube with the lowest expansion degree.

[0087] In the adjustment section, only one expansion tube has the largest expansion degree. Each time the adjustment section performs an expansion degree adjustment, the position of the expansion tube with the largest expansion degree is changed.

[0088] The position change of the expansion tube with the largest expansion degree is changed toward the proximal end of the catheter body 200 , and the position change manner of the expansion tube with the largest expansion degree is that the expansion degree of the expansion tube adjacent to the expansion tube with the largest expansion degree last time becomes the largest.

[0089] The position change of the expansion tube with the largest expansion degree is changed toward the distal end of the catheter body 200 , and the position change manner of the expansion tube with the largest expansion degree is that the expansion degree of the expansion tube adjacent to the expansion tube with the largest expansion degree last time becomes the largest.

[0090] like Figure 6 As shown, in some embodiments shown in the second aspect of the present application, the adjusting section includes a first expansion tube 251 and a second expansion tube 253, the first expansion tubes 251 of all the adjusting sections are connected, the second expansion tubes 253 of all the adjusting sections are connected, and the first expansion tubes 251 and the second expansion tubes 253 are sleeved outside the suction channel 201.

[0091] like Figure 7 As shown, in some embodiments shown in the second aspect of the present application, the adjustment section includes a first expansion tube 251, a second expansion tube 253, a third expansion tube 2521 and a fourth expansion tube 2522, the third expansion tube 2521 and the fourth expansion tube 2522 are distributed on both sides of the first expansion tube 251, and the third expansion tube 2521 is between the first expansion tube 251 and the second expansion tube 253.

[0092] It should be noted that the setting of the adjustment section in the embodiment of the second aspect is the same as the setting of the adjustment in the embodiment of the first aspect, and the relevant principles will not be elaborated one by one here.

[0093] like Figure 8 As shown, when the catheter body 200 needs to be withdrawn from the blood vessel and removed from the body, the external tensile force and the friction of the blood vessel will cause the catheter body 200 to deform, resulting in stress concentration on the inner bend of the blood vessel; Fig. 9 As shown, when the catheter body 200 needs to be pushed into a blood vessel, the external thrust and the friction of the blood vessel wall will cause the catheter body 200 to deform, resulting in stress concentration on the outer bend of the blood vessel.

[0094] like Fig.10 As shown, during the use of the peristaltic thrombus breaking and thrombus removal suction catheter of the second embodiment of the present application before it is in place, the outer surface of the catheter body 200 is in a state of peristaltic reciprocating motion due to the setting of the peristaltic structure, which will partially eliminate the tension, avoid increasing the tension of the catheter body 200, and effectively reduce the risk of catheter withdrawal.

[0095] The present application also provides a method for using the above-mentioned peristaltic thrombus fragmentation and thrombus removal aspiration catheter, and the specific steps are as follows:

[0096] Selecting a catheter body 200 that matches the diameter of the blood vessel;

[0097] The catheter body 200 equipped with a peristaltic structure is delivered to the lesion position of the target blood vessel through an arterial access route;

[0098] The external device for providing suction force starts the suction work, providing negative pressure suction force for the catheter body 200, and the thrombus enters the catheter body 200 under the action of the negative pressure suction force, and then is drawn out of the blood vessel through the catheter body 200;

[0099] The external device providing suction force stops the suction work and removes the catheter body 200 from the human body;

[0100] Wherein, if the peristaltic structure is close to the inner layer of the catheter body 200, during the suction process of the catheter body 200, a flow medium is injected into the expansion tube to adjust the expansion degree of the expansion tube, and each time the adjustment section adjusts the expansion degree, the position of the expansion tube with the largest expansion degree is changed once;

[0101] If the peristaltic structure is close to the outer layer of the catheter body 200, the catheter body 200 injects a flow medium into the expansion tube to adjust the expansion degree of the expansion tube during the pushing and pulling process in the blood vessel. Each time the adjustment section adjusts the expansion degree, the position of the expansion tube with the largest expansion degree changes once.

[0102] The embodiments of the present application are described in detail above in conjunction with the accompanying drawings, but the present application is not limited to the above embodiments, and various changes can be made within the knowledge scope of ordinary technicians in the technical field without departing from the purpose of the present application.

Claims

1. A peristaltic embolus-breaking and embolus-moving suction catheter, characterized in that: include a catheter body, the catheter body comprising a suction channel and an adjustment channel, the adjustment channel being adjacent to the suction channel; A peristaltic structure, at least a portion of the regulating channel is provided with the peristaltic structure, the peristaltic structure comprises a plurality of regulating segments arranged along the axial direction of the catheter body, the expansion degree between the two ends of the regulating segment is adjustable, the regulating segment compresses the suction channel when expanded, the portions of two adjacent regulating segments with the largest expansion degrees are not adjacent, and the regulating segment causes a portion of the channel wall of the suction channel to have a corrugated structure along the axial direction.

2. A peristaltic embolus-breaking and embolus-moving suction catheter, characterized in that: include A catheter body, the catheter body comprising an outer tube layer, an adjustment channel and a suction channel for aspirating thrombus, the adjustment channel being adjacent to the outer tube layer; A peristaltic structure, at least a portion of the adjustment channel is provided with the peristaltic structure, the peristaltic structure comprises a plurality of adjustment segments arranged along the axial direction of the catheter body, the expansion degree between the two ends of the adjustment segment is adjustable, the adjustment segment adjusts the surface shape of the outer tube layer when expanded, the portions with the largest expansion degrees of two adjacent adjustment segments are not adjacent, and the adjustment segment causes a portion of the surface of the outer tube layer to have a corrugated structure along the axial direction.

3. The peristaltic thrombus-breaking and thrombus-moving suction catheter according to claim 1 or 2, characterized in that: The adjustment section includes at least two expansion tubes, the expansion tubes are annular, the suction channel passes through the expansion tubes, and the expansion tubes at the same position of all the adjustment sections are connected.

4. The peristaltic thrombus-breaking and thrombus-moving suction catheter according to claim 3 is characterized in that: Assuming that the diameter of the expansion tube is D, the center distance between two adjacent expansion tubes is greater than or equal to 1.5D.

5. The peristaltic embolus-breaking and embolus-moving suction catheter according to claim 3, characterized in that: Suppose the number of the expansion tubes is N. When the number of the expansion tubes exceeds 2, N is a multiple of 2. Suppose the number of the expansion tubes between the expansion tube with the largest expansion degree and the expansion tube with the lowest expansion degree is n, and n=(N-2) / 2.

6. The peristaltic embolus-breaking and embolus-moving suction catheter according to claim 4, characterized in that: The number of the expansion tubes is at least 4, and the expansion degrees of the expansion tubes gradually decrease from the expansion tube with the largest expansion degree to the expansion tube with the lowest expansion degree.

7. The peristaltic embolus-breaking and embolus-moving suction catheter according to claim 6, characterized in that: In the adjustment section, only one expansion tube has the largest expansion degree. Each time the adjustment section performs an expansion degree adjustment, the position of the expansion tube with the largest expansion degree is changed.

8. The peristaltic embolus-breaking and embolus-moving suction catheter according to claim 7, characterized in that: The position of the expansion tube with the largest expansion degree is changed toward the proximal end of the catheter body, and the position of the expansion tube with the largest expansion degree is changed in such a way that the expansion degree of the expansion tube adjacent to the expansion tube with the largest expansion degree last time becomes the largest.

9. The peristaltic embolus-breaking and embolus-moving suction catheter according to claim 7, characterized in that: The position of the expansion tube with the largest expansion degree is changed toward the distal end of the catheter body, and the position of the expansion tube with the largest expansion degree is changed in such a way that the expansion degree of the expansion tube adjacent to the expansion tube with the largest expansion degree last time becomes the largest.

10. A method for using a peristaltic thrombus-breaking and thrombus-moving suction catheter, based on the peristaltic thrombus-breaking and thrombus-moving suction catheter according to any one of claims 3 to 9, characterized in that: The steps include: Select a catheter body that matches the diameter of the blood vessel; Delivering the catheter body equipped with the peristaltic structure to the lesion site of the target blood vessel through an arterial access route; The external device for providing suction force starts the suction work, provides negative pressure suction force for the catheter body, and the thrombus enters the catheter body under the action of the negative pressure suction force, and then is drawn out of the blood vessel through the catheter body; The external device providing suction force stops the suction work, and the catheter body is withdrawn from the human body; Wherein, if the peristaltic structure is close to the inner layer of the catheter body, a flow medium is injected into the expansion tube during the suction process of the catheter body to adjust the expansion degree of the expansion tube, and each time the adjustment section adjusts the expansion degree, the position of the expansion tube with the largest expansion degree is changed once; If the peristaltic structure is close to the outer layer of the catheter body, the catheter body injects flow medium into the expansion tube to adjust the expansion degree of the expansion tube during the pushing and pulling process in the blood vessel. Each time the adjustment section adjusts the expansion degree, the position of the expansion tube with the largest expansion degree changes once.

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