Interventional operation system with OCT (optical coherence tomography) probe

Abstract

The utility model discloses an interventional operation operating system with an OCT probe, and relates to the technical field of medical instruments. The interventional surgery operating system with the OCT probe comprises a micro catheter, a probe head and an OCT probe, the OCT probe is arranged at the front end of the micro catheter; the recovery pipe is arranged at the front end of the OCT probe; the recovery pipe is provided with a first through hole and a second through hole; a first control microfilament and a protective umbrella; the front end of the first control microfilament is connected with the protective umbrella; the front end of the first control microwire can penetrate into the recycling pipe through the first through hole; a micro guide wire; the front end of the micro guide wire can penetrate into the recycling pipe through the second through hole. According to the application, the micro catheter does not need to be drawn out of the carotid artery, then the OCT probe is inserted into the carotid artery, and scanning detection of a narrow part can be realized only by moving the micro catheter in the carotid artery by a small distance (dozens of millimeters or dozens of millimeters).

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and specifically to an interventional surgery operating system with an OCT probe. Background Art

[0002] The carotid artery is the main pathway for blood supply to the brain. Once it is narrowed or blocked, it will cause insufficient blood supply to the head organs (brain or eyes, etc.). Figure 1 As shown, carotid artery occlusion is caused by abnormal masses 2 (atheromatous plaques or abnormal hyperplasia masses, etc.) attached to the inner wall of the carotid artery 1. The abnormal mass 2 forms a stenosis 11 inside the carotid artery 1. The diameter of the stenosis 11 is extremely small or zero, which causes the carotid artery 1 to be stenotic or occluded, making it difficult for the heart to supply blood to the head organs. Over time, patients will experience symptoms of cerebral infarction such as dizziness, headache, visual impairment, aphasia, limb impairment, and severe cases may fall into a coma, threatening their lives. In order to solve this technical problem, the prior art generally adopts a method of setting a stent at the stenosis 11 to support the carotid artery 1, thereby ensuring that the blood in the carotid artery 1 can smoothly pass through the stenosis 11.

[0003] It should be understood that before stenting the stenosis 11 of the carotid artery 1, Figure 2 As shown, a protective umbrella 7 is provided in the carotid artery 1 to prevent abnormal masses 2 (e.g., thrombi) from falling off during the stenting process, thereby blocking the cerebral blood vessels. Figure 2 As shown, the protective umbrella 7 is generally hidden in the microcatheter 4. When in use, the protective umbrella 7 is controlled by a control microwire (i.e., the first control microwire 71) to be released from the microcatheter 4 or recovered into the microcatheter 4. Specifically, the steps for releasing the protective umbrella are as follows: first, the microguide wire 3 is passed through the narrow part 11; then, the microcatheter 4 with the protective umbrella 7 inside is passed through the narrow part 11 under the guidance of the microguide wire 3; then, the protective umbrella 7 is released from the microcatheter 4 through the first control microwire 71. Since the protective umbrella 7 is made of nickel-titanium alloy and has a shape memory property, the protective umbrella 7 can be released as follows. Figure 2As shown, the abnormal mass 2 that has fallen off in the carotid artery 1 can be intercepted to prevent the abnormal mass 2 from flowing into or blocking other blood vessels. After releasing the protective umbrella 7, in order to detect the abnormality of the stenosis 11, it is necessary to extract the microcatheter 4 from the carotid artery 1, and then send the optical coherence tomography (OCT) probe along the micro-guidewire 3 into the stenosis 11 of the carotid artery 1 to detect the stenosis 11, so as to facilitate subsequent operations. It should be noted that the above-mentioned operation steps are relatively cumbersome, resulting in a long operation time and high difficulty in operation. It is easy to understand that the longer the operation time, the greater the risk borne by the patient, and the operation of inserting and withdrawing the microcatheter 4 or the OCT probe multiple times increases the risk of damage to the inner wall of the carotid artery 1. Utility Model Content

[0004] The purpose of the present application is to provide an interventional surgery operating system with an OCT probe to solve the technical problems in the prior art of the two steps of releasing the protective umbrella and detecting the stenosis, which are complicated and difficult to operate.

[0005] To achieve the above objectives, this application provides the following technical solutions:

[0006] An interventional surgery operating system with an OCT probe, comprising:

[0007] Microcatheter;

[0008] An OCT probe is arranged at the front end of the microcatheter;

[0009] A recovery tube is arranged at the front end of the OCT probe; the recovery tube is provided with a first through hole and a second through hole;

[0010] A first control microfilament and a protective umbrella; the front end of the first control microfilament is connected to the protective umbrella; the front end of the first control microfilament can penetrate into the interior of the recovery tube through the first through hole;

[0011] Micro guide wire; the front end of the micro guide wire can penetrate into the interior of the recovery tube through the second through hole.

[0012] As a specific solution in the technical solution of the present application, it also includes a balloon; the balloon and the microcatheter are an integrated structure.

[0013] As a specific solution in the technical solution of this application, it also includes:

[0014] The balloon is a tubular structure, and the balloon can be movably sleeved on the outside of the microcatheter; a closed cavity is formed inside the balloon;

[0015] A push catheter is connected to the rear end of the balloon; the push catheter is communicated with the closed cavity.

[0016] As a specific solution in the technical solution of this application, the balloon includes:

[0017] The bearing member is a tubular structure;

[0018] The film is arranged outside the carrier; the closed cavity is formed between the carrier and the film.

[0019] As a specific solution in the technical solution of the present application, the support member includes a support tube; guide parts are provided at both ends of the support tube; the outer diameter of the guide part decreases along the first direction; the first direction is parallel to the axial direction of the support tube, and is pointed from the guide part to the support tube.

[0020] As a specific solution in the technical solution of the present application, the maximum outer diameter of the guide part is greater than the outer diameter of the supporting tube; an accommodation groove is formed between the supporting tube and the two guide parts; and the film is stacked in the accommodation groove.

[0021] As a specific solution in the technical solution of the present application, a plurality of micro-titanium alloy wires are arranged inside the film; each micro-titanium alloy wire is used to form elastic potential energy if the current state of the film is different from the initial state, and the elastic potential energy is used to make the film tend to change from the current state to the initial state.

[0022] As a specific scheme in the technical scheme of the present application, the thin film stack forms a plurality of stacked parts; each stacked part includes at least a first stacked film and a second stacked film; the first stacked film and the second stacked film are any two adjacent films in the corresponding stacked part; a plurality of connecting microcolumns are arranged between each stacked part and the carrier, and each connecting microcolumn is distributed along the axial array of the carrier; the fracture stress of the connecting microcolumn is less than the cracking stress of the thin film; one end of each connecting microcolumn is connected to the first stacked film, and the other end of each connecting microcolumn is connected to the second stacked film; or, one end of each connecting microcolumn is connected to the thin film, and the other end of each connecting microcolumn is connected to the carrier.

[0023] As a specific solution in the technical solution of the present application, the outer diameter of the microcatheter is smaller than the inner diameter of the carrier; the recovery tube is also provided with a limiting ring, which is close to the front end of the recovery tube; the maximum outer diameter of the limiting ring is larger than the inner diameter of the carrier.

[0024] As a specific solution in the technical solution of this application, it also includes:

[0025] A protection tube; the protection tube is more flexible than the recovery tube;

[0026] The second control microwire; the recovery tube is also provided with a third through hole, and the front end of the second control microwire can penetrate into the interior of the recovery tube through the third through hole;

[0027] A plurality of connecting microwires; one end of each connecting microwire is connected to the front end of the second control microwire, and the other end of each connecting microwire is connected to the rear end of the protection tube.

[0028] Compared with the prior art, the beneficial effects of this application are:

[0029] The present application does not need to extract the microcatheter from the carotid artery and then insert the OCT probe into the carotid artery. Instead, the microcatheter only needs to be moved a small distance (a dozen or tens of millimeters) in the carotid artery to scan and detect the stenosis. In other words, compared with the prior art, the interventional surgery operating system with an OCT probe proposed in the present application makes the two operation steps of releasing the protective umbrella and scanning and detecting the stenosis relatively simple, with low operation difficulty, and can reduce the risk borne by the patient during the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 Schematic diagram of carotid artery occlusion;

[0031] Figure 2 A schematic diagram of the use of an interventional surgery operating system with an OCT probe in the prior art;

[0032] Figure 3 A three-dimensional schematic diagram of an interventional surgery operating system with an OCT probe proposed in an embodiment of the present application;

[0033] Figure 4 for Figure 3 A cross-sectional schematic diagram of an interventional surgical operating system with an OCT probe;

[0034] Figure 5 A three-dimensional schematic diagram of another interventional surgery operating system with an OCT probe proposed in an embodiment of the present application;

[0035] Figure 6 A front view schematic diagram of a protection tube proposed in an embodiment of the present application;

[0036] Figure 7 A schematic diagram of the use of an interventional surgery operating system with an OCT probe proposed in an embodiment of the present application;

[0037] Figure 8 A three-dimensional schematic diagram of another interventional surgery operating system with an OCT probe proposed in an embodiment of the present application;

[0038] Fig. 9 for Figure 8 A front view schematic diagram of an interventional surgery operating system with an OCT probe;

[0039] Fig.10 A schematic cross-sectional view of a balloon proposed in an embodiment of the present application;

[0040] Fig.11 A cross-sectional schematic diagram of another balloon proposed in an embodiment of the present application;

[0041] Fig.12 A three-dimensional schematic diagram of a carrier proposed in an embodiment of the present application;

[0042] Fig.13 A balloon according to an embodiment of the present application is provided Fig. 9 Schematic cross-sectional view of the AA line;

[0043] Fig.14 for Fig.13 An enlarged view of part B;

[0044] Fig.15 for Fig.13 After the first inflation of the balloon Fig. 9 Schematic cross-sectional view of the AA line;

[0045] Fig.16 for Fig.13 After the second inflation of the middle balloon, Fig. 9 Schematic cross-sectional view of the AA line;

[0046] Fig.17 Another balloon proposed in the embodiment of the present application is according to Fig. 9 Schematic cross-sectional view of the AA line;

[0047] Fig.18 Another balloon proposed in the embodiment of the present application is according to Fig. 9 Schematic cross-sectional view of the AA line;

[0048] Fig.19 for Fig.13 Another enlarged view of part B;

[0049] Fig. 20 for Fig.13 After the movable balloon is inflated for the first time, Fig. 9 Schematic diagram of the cross-section along line AA.

[0050] In the figure: 1. carotid artery; 11. stenosis; 2. abnormal mass; 3. micro guide wire; 4. micro catheter; 41. limiting ring; 42. recovery tube; 43. protection tube; 44. connecting micro wire; 45. second control micro wire; 5. balloon; 51. closed cavity; 52. support member; 521. support tube; 522. guide part; 523. placement groove; 53. film; 531. connecting micro column; 532. micro titanium alloy wire; 533. first laminated membrane; 534. second laminated membrane; 6. push catheter; 7. protective umbrella; 71. first control micro wire; 8. OCT probe. DETAILED DESCRIPTION

[0051] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0052] It should be noted that, in the description of the present application, the terms "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating directions or positional relationships, are based on the directions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description. They do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore should not be understood as a limitation on the present application.

[0053] Furthermore, it should be understood that for the sake of ease of description, the sizes of the various components shown in the drawings are not drawn according to actual proportions. For example, the thickness or width of certain layers may be exaggerated relative to other layers.

[0054] It should be noted that like reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined or described in one drawing, it will not require further detailed discussion and description in the description of the subsequent drawings.

[0055] Before understanding the embodiments of the present application, it should be clear that in the embodiments of the present application below, only the application scenario of carotid artery occlusion is used as an example to illustrate the interventional surgery operating system with an OCT probe proposed in the present application. It does not mean that the interventional surgery operating system with an OCT probe proposed in the present application is only applicable to the application scenario of carotid artery occlusion. It should be understood that the interventional surgery operating system with an OCT probe proposed in the present application is applicable to all other application scenarios similar to the application scenario of carotid artery occlusion. For example, application scenarios such as coronary artery occlusion, pulmonary artery occlusion or cerebral artery occlusion are not listed one by one here.

[0056] It should be noted that, in this embodiment, Figure 1 As shown, if the application scenario is carotid artery occlusion, the minimum diameter of the stenosis 11 is zero; if the application scenario is carotid artery stenosis, the minimum diameter of the stenosis 11 is greater than zero. That is to say, in this embodiment, the application scenario of the interventional surgery operating system with an OCT probe can be carotid artery stenosis or carotid artery occlusion, which will not be described in detail later.

[0057] Before understanding the embodiments of the present application, it is also necessary to understand that most of the parts (such as micro-guidewire 3, micro-catheter 4 or balloon 5, etc.) in the interventional surgery operating system with an OCT probe have two ends. In the embodiments of the present application below, the two ends of a part are defined as the front end and the rear end, respectively, where the front end refers to the end of the part that first enters the carotid artery 1 when used, and the rear end refers to the end of the part that does not enter or enters the carotid artery 1 later when used, which will not be described in detail later.

[0058] In order to solve the technical problem that the two steps of releasing the protective umbrella and detecting the stenosis in the prior art are complicated and difficult to operate, the present application proposes an interventional surgery operating system with an OCT probe. Specifically, the interventional surgery operating system with an OCT probe includes a micro guide wire 3, a micro catheter 4, a recovery tube 42, an OCT probe 8, a first control micro wire 71 and a protective umbrella 7. Figure 3 As shown, the OCT probe 8 is disposed at the front end of the microcatheter 4. The recovery tube 42 is disposed at the front end of the OCT probe 8, and the recovery tube 42 is also provided with a first through hole and a second through hole. Figure 4 As shown, the front end of the first control microwire 71 is connected to the protective umbrella 7, and the front end of the first control microwire 71 can penetrate into the interior of the recovery tube 42 through the first through hole. The front end of the micro guide wire 3 can penetrate into the interior of the recovery tube 42 through the second through hole.

[0059] Before use, Figure 4As shown, the protective umbrella 7 is arranged inside the recovery tube 42, and the front end of the first control microwire 71 penetrates into the recovery tube 42 through the first through hole and is connected to the protective umbrella 7. The microguidewire 3 is penetrated into the recovery tube 42 through the second through hole, and passes out from the front end of the recovery tube 42. When in use, the microguidewire 3 is first passed through the stenosis 11 in the patient's carotid artery 1; then, under the guidance of the microguidewire 3, the recovery tube 42 is passed through the stenosis 11; further, the protective umbrella 7 is pushed out of the recovery tube 42 through the first control microwire 71 and released, and the protective umbrella 7 made of nickel-titanium alloy can automatically restore to its original state, thereby blocking the carotid artery 1, preventing the detached abnormal mass 2 from flowing into or blocking other blood vessels; further, the microcatheter 4 is moved so that the OCT probe 8 is located at the stenosis 11, and then the stenosis 11 is scanned and detected by the OCT probe 8. Compared with the prior art, it is necessary to extract the microcatheter 4 from the carotid artery 1 and then insert the OCT probe 8 into the carotid artery 1 to scan and detect the stenosis 11 in the carotid artery 1. In the present application, it is only necessary to move the microcatheter 4 a small distance (tens of millimeters or tens of millimeters) in the carotid artery 1 to scan and detect the stenosis 11. In other words, compared with the prior art, the two operation steps of releasing the protective umbrella and scanning and detecting the stenosis in the present application are relatively simple, with low operation difficulty, and can reduce the risk borne by the patient during the operation.

[0060] It should be noted that after the stent is set at the stenosis 11, it is necessary to drag the protective umbrella 7 back to the inside of the recovery tube 42 through the first control microwire 71, so that the plaques such as thrombi collected in the protective umbrella 7 can be smoothly taken out of the patient's body. Generally, in order for the protective umbrella 7 to be smoothly recovered to the inside of the recovery tube 42, the recovery tube 42 itself needs to have a certain rigidity. It is easy to understand that if the rigidity of the recovery tube 42 is strong, when the recovery tube 42 passes through the stenosis 11 along the microguide wire 3 during use, the front end of the recovery tube 42 with strong rigidity is easy to scratch or break the inner wall of the carotid artery 1. In order to prevent the interventional surgery operating system with an OCT probe from scratching or breaking the inner wall of the carotid artery 1 during use, and the recovery tube 42 can normally recover the protective umbrella 7, in one embodiment of the present application, the interventional surgery operating system with an OCT probe may also include a protective tube 43, a second control microwire 45 and a plurality of connecting microwires 44. In this embodiment, the flexibility of the protection tube 43 is greater than that of the recovery tube 42, that is, the rigidity of the recovery tube 42 is greater than that of the protection tube 43. As Figure 5 As shown, the recovery tube 42 is also provided with a third through hole, and the front end of the second control microwire 45 can penetrate into the interior of the recovery tube 42 through the third through hole. Figure 6 As shown, one end of each connecting microwire 44 is connected to the front end of the second control microwire 45 , and the other end of each connecting microwire 44 is connected to the rear end of the protection tube 43 .

[0061] When using, Figure 5 As shown, the protective tube 43 is located at the front end of the recovery tube 42, and the protective umbrella 7 is arranged inside the protective tube 43. Although the flexibility of the protective tube 43 is greater than that of the recovery tube 42, under the support of the protective umbrella 7, the recovery tube 42 can push the protective tube 43 forward during the advancement of the interventional surgery operating system with the OCT probe along the micro-guidewire 3, that is, the protective tube 43 will not easily enter the recovery tube 42. Due to the good flexibility of the protective tube 43, the front end of the protective tube 43 is also difficult to scratch or break the inner wall of the carotid artery 1 during the advancement of the interventional surgery operating system with the OCT probe along the micro-guidewire 3. If the protective umbrella 7 needs to be released, the protective umbrella 7 can be pushed out of the protective tube 43 by the first control microwire 71, thereby completing the release of the protective umbrella 7. If the release of the protective umbrella 7 is completed, the protective tube 43 can be dragged and recovered to the inside of the recovery tube 42 by the second control microwire 45; if the stent of the stenosis 11 is completed, the protective umbrella 7 can also be dragged and recovered to the inside of the recovery tube 42 by the first control microwire 71, thereby realizing the recovery of the protective umbrella 7.

[0062] It should be clear that in this embodiment, since the protective tube 43 with better flexibility is located at the front end of the recovery tube 42 with better rigidity, when the interventional surgery operating system with the OCT probe moves along the micro-guidewire 3, the first thing that contacts the inner wall of the carotid artery 1 must be the protective tube 43. In other words, as long as the flexibility of the protective tube 43 and the rigidity of the recovery tube 42 are reasonably controlled, it is possible to protect the inner wall of the carotid artery 1 and to stably recover the protective umbrella 7.

[0063] In the embodiment of the present application, there is no restriction on the material of the recovery tube 42, as long as its rigidity can meet the recovery of the protective umbrella 7. For example, the recovery tube 42 can be a polyethylene tube, a polyamide tube or a polyurethane tube. In the embodiment of the present application, there is no restriction on the material of the protection tube 43. For example, its material can be the same as that of the recovery tube 42, but in order to ensure that the protection tube 43 has sufficient flexibility, the thickness of the protection tube 43 can be much smaller than the thickness of the recovery tube 42. For example, the thickness of the protection tube 43 can be 1 / 5 or 1 / 10 of the thickness of the recovery tube 42. In other words, relative to the recovery tube 42 which can be in the shape of a thick-walled hollow tube, the protection tube 43 can be in the shape of a thin-walled hollow tube.

[0064] In the embodiment of the present application, there is no restriction on the materials of the first control microwire 71 and the second control microwire 45. For example, the first control microwire 71 and the second control microwire 45 can be plastic microwires or metal microwires. For the convenience of production, the first control microwire 71 and the second control microwire 45 can be made of the same material as the micro-guide wire 3.

[0065] In the embodiment of the present application, the diameters of the first control microwire 71 and the second control microwire 45 can be selected according to the requirements. For example, the diameters of the first control microwire 71 and the second control microwire 45 can be greater than or equal to 5 micrometers and less than or equal to 20 micrometers.

[0066] In the embodiment of the present application, there is no restriction on the material of the connecting microwire 44, as long as the connecting microwire 44 can connect the second control microwire 45 and the protection tube 43. For example, the connecting microwire 44 can be a metal wire or a plastic wire.

[0067] It should be clear that after the OCT probe is used to scan and detect the stenosis, the OCT probe needs to be withdrawn from the carotid artery, and the balloon is pushed along the micro-guidewire to the stenosis of the carotid artery; finally, the balloon is filled with a medium (air or saline, etc.) so that the balloon can swell, and the swollen balloon can pre-expand the stenosis of the carotid artery so that the stenosis has a sufficient size, so that the stent can be smoothly installed in the stenosis of the carotid artery. It should be noted that after the pre-expansion of the stenosis of the carotid artery is completed, the balloon needs to be withdrawn from the carotid artery, and the OCT probe is placed in the stenosis after the pre-expansion is completed, and then the stenosis is scanned again by the OCT probe. If the size of the stenosis after pre-expansion does not meet the requirements, the OCT probe needs to be withdrawn from the carotid artery, and the balloon is placed in the stenosis, and the stenosis is pre-expanded again until the OCT probe detects that the size of the stenosis after pre-expansion meets the installation requirements of the stent. The above operation steps are relatively cumbersome, resulting in long operation time and high difficulty. It is easy to understand that the longer the operation time, the greater the risk to the patient, and the risk of damaging the inner wall of the carotid artery due to multiple withdrawal and insertion of the balloon or OCT probe also increases accordingly.

[0068] In order to further reduce the difficulty and duration of the operation, that is, to reduce the risk borne by the patient, in one embodiment of the present application, the interventional surgery operating system with the OCT probe further includes a balloon 5. Figure 7 As shown, the balloon 5 and the microcatheter 4 can be an integrated structure.

[0069] When in use, after the OCT probe 8 is used to scan and detect the stenosis 11, the microcatheter 4 can be pushed under the guidance of the micro-guidewire 3 to push the balloon 5 on the microcatheter 4 to the stenosis 11; further, a medium is filled into the balloon 5 so that the balloon 5 can be expanded, and then Figure 7As shown, the balloon 5 can pre-expand the stenosis 11; after the pre-expanding is completed, the medium in the balloon 5 is extracted to restore the balloon 5 to its original state, and then the OCT probe 8 is moved to the stenosis 11 of the carotid artery 1 through the microcatheter 4 to scan the stenosis 11. If the size of the stenosis 11 after pre-expanding does not meet the requirements, the balloon 5 is moved to the stenosis 11 of the carotid artery 1 to perform the pre-expanding operation again until the OCT probe 8 detects that the size of the stenosis 11 after pre-expanding meets the requirements.

[0070] In the embodiment of the interventional surgery operating system with an OCT probe proposed in this application, both the balloon and the OCT probe are set in a microcatheter. When in use, there is no need to frequently withdraw or insert the balloon or the OCT probe from the carotid artery. It only needs to move the balloon or the OCT probe in the carotid artery for a small distance (tens of millimeters or tens of millimeters). The operation is easy and the operation time is short, which can reduce the risk of damage to the inner wall of the patient's carotid artery and other risks borne by the patient during the operation.

[0071] From the previous text, we can see that Figure 7 As shown, the balloon 5 and the microcatheter 4 can be an integrated structure. The balloon 5 and the OCT probe 8 are sequentially arranged on the microcatheter 4, and between the balloon 5 and the OCT probe 8, the OCT probe 8 is closer to the front end of the microcatheter 4.

[0072] It should be noted that if the microcatheter 4 and the balloon 5 are an integrated structure, the balloon 5 is at a certain distance from the front end of the recovery tube 42 due to the presence of the OCT probe 8 and the recovery tube 42. If the stenosis 11 is located at the end of the carotid artery 1, during use, although the OCT probe 8 and the recovery tube 42 can pass through the stenosis 11 smoothly, the balloon 5 on the microcatheter 4 is difficult to reach the stenosis 11 smoothly. If the balloon 5 is forcibly pushed to the stenosis 11, due to the limited accommodation space at the end of the carotid artery 1, the front end of the recovery tube 42 may damage the inner wall of the end of the carotid artery 1 at the least, or cause the front end of the recovery tube 42 to rupture the carotid artery 1 at the worst.

[0073] In order to prevent the front end of the recovery tube 42 from damaging the inner wall of the end of the carotid artery 1 or causing the carotid artery 1 to rupture when the stenosis 11 is located at the end of the carotid artery 1, in one embodiment of the present application, Fig.10 or Fig.11 As shown, the balloon 5 is a tubular structure, and a closed cavity 51 is formed inside the balloon 5. Figure 8 and Fig. 9 As shown, the balloon 5 can be movably sleeved on the outside of the microcatheter 4. The interventional surgery operating system with the OCT probe also includes a push catheter 6, which is connected to the rear end of the balloon 5 and communicates with the closed cavity 51.

[0074] When in use, the microguidewire 3 is first passed through the stenosis 11 of the carotid artery 1; then, under the guidance of the microguidewire 3, the microcatheter 4 is passed through the stenosis 11 of the carotid artery 1; further, under the guidance of the microcatheter 4, the balloon 5 is moved to the stenosis 11 of the carotid artery 1 through the push catheter 6; finally, a medium (for example, air or saline) is filled into the closed cavity 51 in the balloon 5 through the push catheter 6 to inflate the balloon 5, thereby pre-dilatating the stenosis 11 of the carotid artery 1.

[0075] In this embodiment, since the balloon 5 can be moved along the microcatheter 4 through the push catheter 6, as long as the microcatheter 4 can smoothly pass through the stenosis 11 of the carotid artery 1, the balloon 5 can also smoothly pass through the stenosis 11 of the carotid artery 1, and then the stenosis 11 can be pre-dilated based on the balloon 5. Compared with the embodiment in which the microcatheter and the balloon are integrated, the interventional surgery operating system with an OCT probe proposed in this embodiment can be applicable to the application scenario in which the stenosis is located at the end of the carotid artery.

[0076] In the embodiment of the present application, the push catheter 6 is a catheter that can apply a push force to the balloon 5, so the push catheter 6 needs to have a certain rigidity. If the push catheter 6 is too rigid, the push catheter 6 is likely to damage the vascular wall of the carotid artery 1 during the pushing process. In order to ensure that the push catheter 6 has a certain rigidity and is not likely to damage the vascular wall of the carotid artery 1, in the embodiment of the present application, the material of the push catheter 6 can be the same as that of the microcatheter 4. For example, the push catheter 6 can be made of polyamide, polyurethane, or polytetrafluoroethylene.

[0077] In the embodiments of the present application, there is no limitation on the shape and structure of the balloon 5, as long as the balloon 5 can move along the microcatheter 4 under the push and pull action of the push catheter 6 and can expand after being filled with a medium. For example, the balloon 5 can be at least as shown in the following two embodiments.

[0078] Balloon Embodiment 1

[0079] In this embodiment, the balloon 5 can be Fig.10 As shown, it can be a one-piece balloon with uniform wall thickness. As can be seen from the foregoing, the balloon 5 needs to be able to move along the microcatheter 4 under the pushing action of the push catheter 6, that is, the balloon 5 itself needs to have good rigidity. After reaching the stenosis 11, the balloon 5 needs to be inflated, that is, the balloon 5 itself also needs to have good flexibility.

[0080] Example 2 of the balloon

[0081] If the balloon 5 is integrally formed and has a uniform wall thickness, the balloon 5 is either insufficiently rigid or insufficiently flexible, that is, the use effect of the balloon 5 is poor. In order to improve the use effect of the balloon 5, in this embodiment, the balloon 5 includes a carrier 52 and a film 53. Fig.11 As shown, the carrier 52 is a tubular structure. The film 53 is arranged outside the carrier 52 , and the closed cavity 51 is formed between the carrier 52 and the film 53 .

[0082] When in use, the support member 52 is mainly used to provide rigidity so that the balloon 5 can move along the microcatheter 4 under the pushing action of the push catheter 6. The film 53 is mainly used to provide flexibility so that after the balloon 5 reaches the stenosis 11, the medium is filled into the closed cavity 51, and the film 53 can swell, thereby pre-dilatating the stenosis 11. In this embodiment, the balloon 5 has a good use effect through the arrangement of the support member 52 and the film 53. It should be noted that, in this embodiment, the strong rigidity of the support member 52 means that the rigidity of the support member 52 is greater than the rigidity of the film 53. Since the support member 52 needs to pass through the blood vessel when in use, the support member 52 also needs to be able to bend appropriately to adapt to the bending changes of the blood vessel.

[0083] In this embodiment, the support member 52 can be made of the same material as the film 53. If the support member 52 and the film 53 are made of the same material, the thickness of the support member 52 along the radial direction of the balloon 5 can be significantly greater than the thickness of the film 53, so that the support member 52 has good rigidity and the film 53 can have good flexibility.

[0084] In the embodiment of the present application, there is no limitation on the shape and structure of the support member 52. For example, the support member 52 may be in the shape of a round tube (for example, only including Fig.12 The supporting tube 521 shown in FIG. 5 ) or the supporting member 52 may be as shown in FIG. Fig.12 As shown, it includes a support tube 521. Both ends of the support tube 521 are provided with guide parts 522, and the outer diameter of the guide parts 522 decreases along the first direction. The first direction is parallel to the axial direction of the support tube 521, and the guide parts 522 point to the support tube 521.

[0085] It should be clear that, since the outer diameter of each guide portion 522 decreases along the first direction, the first direction is parallel to the axial direction of the support tube 521, and the first direction is directed from the guide portion 522 to the support tube 521. In other words, during the movement of the support member 52 in the carotid artery 1, since the outer diameters of the front and rear ends of the support member 52 are both small and decrease, the support member 52 is easy to move in the carotid artery 1, and the front or rear end of the support member 52 is not easy to damage the inner wall of the carotid artery 1.

[0086] It is easy to understand that in this embodiment, the expansion and contraction of the balloon 5 mainly depends on the film 53. After the film 53 changes from the expanded state to the contracted state, wrinkles or protrusions are easily formed on its surface. If these wrinkles or protrusions rub against the inner wall of the cerebral artery 1, it is easy to damage the inner wall of the cerebral artery 1. In order to prevent the film 53 from rubbing against the inner wall of the carotid artery 1 during the movement of the balloon 5, that is, the film 53 is not easy to damage the inner wall of the carotid artery 1, in this embodiment, Fig.12 As shown, the maximum outer diameter of the guide portion 522 can be greater than the outer diameter of the support tube 521, that is, a placement groove 523 can be formed between the support tube 521 and the two guide portions 522. When in use, the film 53 can be arranged between the two guide portions 522, that is, the film 53 is arranged in the placement groove 523. Since the film 53 is located in the placement groove 523, the film 53 will not form friction with the inner wall of the carotid artery 1 during the movement of the balloon 5. If the film 53 does not form friction with the inner wall of the carotid artery 1, the film 53 will not easily damage the inner wall of the carotid artery 1.

[0087] In the embodiments of the present application, Fig.11 As shown, the film 53 may be a film with excellent elasticity, so when the medium is filled into the closed cavity 51, the film 53 can swell, thereby pre-dilatating the stenosis 11. Fig.13 As shown, the film 53 may also be a film with poor elasticity. During production, the film 53 may be stacked and arranged in the placement groove 523. When the medium is filled into the closed cavity 51, the film 53 may also swell, thereby pre-dilatating the stenosis 11. Thus, the second embodiment of the balloon is introduced.

[0088] It should be noted that if the film 53 has excellent elasticity, after the medium in the closed cavity 51 is extracted, the film 53 can automatically retract into the placement groove 523 under the action of its own elasticity. That is, after the pre-expansion is completed, the film 53 with excellent elasticity can still maintain a state where it does not form friction with the inner wall of the carotid artery 1, that is, the film 53 with excellent elasticity is not easy to damage the inner wall of the carotid artery 1. If the film 53 has poor elasticity and is arranged in the placement groove 523 in a stacked manner, after use, even if the medium in the closed cavity 51 is extracted, it cannot be guaranteed that the film 53 can be completely retracted into the placement groove 523. If the film 53 has wrinkles or protrusions, these wrinkles or protrusions may protrude outside the placement groove 523, and then form friction with the inner wall of the carotid artery 1, that is, the inner wall of the carotid artery 1 may be damaged.

[0089] In order to ensure that the film 53 can be completely and smoothly retracted into the placement groove 523 after the medium in the closed chamber 51 is extracted regardless of the elasticity of the film 53. In one embodiment of the present application, a plurality of micro titanium alloy wires 532 (i.e., as shown in FIG. 5A ) may be arranged inside the film 53. Fig.17Or Fig.18 Each titanium alloy wire 532 is used to determine the current state of the film 53 (e.g., Fig.15 and Fig.16 The used state shown) and the initial state (that is, Fig.17 or Fig.18 If the state of use is different from that shown in the figure, each micro-titanium alloy wire 532 forms elastic potential energy, and the elastic potential energy is used to make the film 53 have a tendency to change from the current state to the initial state.

[0090] In this embodiment, Fig.17 As shown in FIG. 1 , each micro titanium alloy wire 532 is in a ring shape connected end to end, and the folded shape of the micro titanium alloy wire 532 is the same as the stacked shape of the film 53. That is, if the film 53 is supported by an external force, when the external force is removed, the film 53 can be restored to its initial state under the elastic force formed by the micro titanium alloy wire 532, that is, restored to the state as shown in FIG. Fig.17 In this embodiment, the initial stacking form can also be Fig.18 As shown in FIG. 1 , a micro titanium alloy wire 532 is arranged at the stacking turning point of the film 53, and the micro titanium alloy wire 532 makes the stacked films of two adjacent layers have a tendency to close together. That is to say, if the film 53 is supported by an external force, when the external force is removed, the two layers of film at the stacking turning point of the film 53 close together under the elastic force of the micro titanium alloy wire 532, and finally can be restored to the initial state, that is, restored to the state as shown in FIG. Fig.18 The initial stacking morphology is shown.

[0091] It should be noted that in the embodiments of the present application, only Fig.17 and Fig.18 The stacking state of the film 53 shown in the figure is used to illustrate the initial state of the film 53 of the present application, and does not mean that the film 53 in the embodiment of the present application can only be stacked as shown in the figure. Fig.17 or Fig.18 It should be understood that in the embodiment of the present application, the film 53 can be stacked according to actual needs, that is, different types of balloons 5 can have films 53 in different stacking states.

[0092] It should be clear that if Figure 1As shown, in the application scenario where the abnormal mass 2 in the carotid artery 1 is relatively large and the stenosis 11 is relatively small, if the balloon 5 is used to expand the size of the stenosis 11 in one go, the carotid artery 1 is likely to rupture, thereby causing a medical accident. In order to avoid the occurrence of such a medical accident, if the stenosis 11 is relatively small, it is generally necessary to use a balloon 5 with a smaller size after inflation (hereinafter referred to as the first balloon) to pre-expand the stenosis 11 for the first time, and then use a balloon 5 with a larger size after inflation (hereinafter referred to as the second balloon) to pre-expand the stenosis 11 for the second time.

[0093] In the prior art, the operating steps for performing two pre-dilations on the stenosis 11 are as follows: first, under the guidance of the micro-guidewire 3, the micro-catheter 4 carrying the first balloon is passed through the stenosis 11, and the first balloon is moved to the stenosis 11, and the first balloon is inflated, so that the first balloon can perform the first pre-dilation on the stenosis 11; then, the micro-catheter 4 carrying the first balloon (the internal medium has been extracted) is extracted from the carotid artery 1; finally, under the guidance of the micro-guidewire 3, the micro-catheter 4 carrying the second balloon is passed through the stenosis 11, and the second balloon is moved to the stenosis 11, and the second balloon is inflated, so that the second balloon can perform the second pre-dilation on the stenosis 11.

[0094] It should be understood that the prior art procedure of performing two pre-dilations on the stenosis 11 is relatively cumbersome, resulting in a long operation time and high difficulty. It is easy to understand that the longer the operation time, the greater the risk borne by the patient, and the multiple withdrawal and insertion of the microcatheter 4 increases the risk of damage to the inner wall of the carotid artery 1. In order to reduce the above risks, in one embodiment of the present application, Fig.13 As shown, the film 53 may be stacked to form a plurality of stacked portions. Fig.14 As shown, each stacked portion includes at least a first stacked film 533 and a second stacked film 534. The first stacked film 533 and the second stacked film 534 are any two adjacent films in the corresponding stacked portion. A plurality of connecting micro-pillars 531 are formed between the first stacked film 533 and the second stacked film 534, and each connecting micro-pillar 531 is distributed in an axial array along the carrier 52. One end of each connecting micro-pillar 531 is connected to the first stacked film 533, and the other end of each connecting micro-pillar 531 is connected to the second stacked film 534. The fracture stress of the connecting micro-pillar 531 is less than the cracking stress of the film 53.

[0095] When in use, the microcatheter 4 can be guided through the narrow part 11 by the micro-guidewire 3; then, the balloon 5 carrying the film 53 can be moved to the narrow part 11 by the push catheter 6 under the guidance of the microcatheter 4; further, a medium with a pressure less than the fracture stress of the connecting micro-pillar 531 is injected into the closed cavity 51 by the push catheter 6, and then Fig.13The film 53 shown can be expanded, and the expanded film 53 is as shown in FIG. Fig.15 As shown, the first pre-expansion can be performed on the stenosis 11. After the first pre-expansion is completed, a medium with a pressure greater than the fracture stress of the connecting micro-pillar 531 and a pressure less than the cracking stress of the film 53 is injected into the closed cavity 51 through the push catheter 6, so that the film 53 can be further expanded. Fig.16 As shown, the stenosis 11 can be pre-dilated for the second time. That is, in this embodiment, two pre-dilations of the stenosis 11 with different size requirements can be achieved through one balloon 5. Compared with the prior art, the operation is simple, and there is no need to insert the microcatheter 4 and the balloon 5 into the carotid artery multiple times, and the time for pre-dilation of the stenosis 11 can be greatly saved, that is, the risk borne by the patient during the operation is reduced.

[0096] In another embodiment of the present application, Fig.19 As shown, one end of each connecting micro-pillar 531 can be connected to the film 53; the other end of each connecting micro-pillar 531 can be connected to the support 52 (that is, the support tube 521). When in use, a medium with a pressure less than the fracture stress of the connecting micro-pillar 531 is injected into the closed cavity 51 through the push conduit 6, and then Fig.13 The film 53 shown can be expanded, and the expanded film 53 is as shown in FIG. Fig. 20 As shown, the first pre-expansion can be performed on the stenosis 11. After the first pre-expansion is completed, a medium with a pressure greater than the fracture stress of the connecting micro-pillar 531 and a pressure less than the cracking stress of the film 53 is injected into the closed cavity 51 through the push catheter 6, so that the film 53 can be further expanded. Fig.16 As shown, the stenosis 11 can be pre-dilated a second time.

[0097] It should be noted that if Figure 7 As shown, when the balloon 5 integrated with the microcatheter 4 is used to dilate the stenosis 11 of the carotid artery 1, the balloon 5 will block the entire carotid artery 1. If the operation time is long, the patient's brain or eyeball and other organs will be insufficiently supplied with blood. In severe cases, it will cause irreversible damage to the patient. In order to avoid the balloon 5 blocking the entire carotid artery 1 when dilating the stenosis 11, in one embodiment of the present application, as shown in FIG. Fig.13 As shown, the outer diameter of the microcatheter 4 (i.e. Fig.13 The outer diameter d) shown in FIG. 5 can be smaller than the inner diameter (ie, the inner diameter of the support member 52 (ie, the support tube 521) Fig.13As shown in the foregoing, since the support member 52 has a certain rigidity, when the medium is filled into the closed cavity 51, the inner wall of the support member 52 will not completely fit with the outer wall of the microcatheter 4. If the inner wall of the support member 52 and the outer wall of the microcatheter 4 do not completely fit, the blood in the carotid artery 1 can flow freely through the gap between the support member 52 and the microcatheter 4. That is, it can effectively avoid the phenomenon of insufficient blood supply to the patient's brain or eyeballs due to complete blockage of the carotid artery 1 when the stenosis 11 of the carotid artery 1 is dilated.

[0098] As can be seen from the foregoing, the interventional surgery operating system with an OCT probe proposed in the present application can be applied to the application scenario where the stenosis 11 is located at the end of the carotid artery 1. Since the accommodation space at the end of the carotid artery 1 is limited, if the stenosis 11 is located at the end of the carotid artery 1, the front end of the recovery tube 42 must be closer to the stenosis 11 during use. If the front end of the recovery tube 42 is closer to the stenosis 11, there is a risk that the balloon 5 will be separated from the microcatheter 4 when the balloon 5 is moved by the push catheter 6. As can be seen from the foregoing, the microcatheter 4 is mainly used to guide the movement of the balloon 5. If the balloon 5 is separated from the microcatheter 4, it is difficult to remove the balloon 5 from the carotid artery 1 without damaging the carotid artery 1. In order to avoid the balloon 5 from being separated from the microcatheter 4 during use, in one embodiment of the present application, the recovery tube 42 may also be provided with a limiting ring 41, such as Figure 8 and Fig. 9 As shown, the limiting ring 41 is close to the front end of the recovery tube 42, and the maximum outer diameter of the limiting ring 41 is larger than the inner diameter of the balloon 5 (that is, as shown in FIG. Fig.13 Inner diameter D shown).

[0099] It should be noted that, in this embodiment, since the outer diameter of the limiting ring 41 is larger than the inner diameter of the balloon 5, the balloon 5 cannot be separated from the microcatheter 4 by the front end of the recovery tube 42 under the limiting effect of the limiting ring 41. In this embodiment, the front end of the limiting ring 41 close to the recovery tube 42 refers to the distance between the front end surface of the limiting ring 41 and the front end surface of the microcatheter 4 (that is, Fig. 9 Of course, in other embodiments of the present application, the distance between the front end surface of the limiting ring 41 and the front end surface of the micro-catheter 4 may also be greater than 2 mm, for example, 4 mm or 5 mm, etc., which is not limited here.

[0100] In the embodiment of the present application, the limiting ring 41 may be any ring that can limit the movement of the balloon 5. For example, the limiting ring 41 may be a ring with a square longitudinal section, wherein the longitudinal section is a section parallel to the axis of the limiting ring 41; the limiting ring 41 may also be Figure 8 and Fig. 9It is easy to understand that if the longitudinal section of the limiting ring 41 is a semicircle, the limiting ring 41 is not easy to damage the inner wall of the carotid artery 1 when moving in the carotid artery 1.

[0101] Compared with the prior art, the embodiment of the interventional surgery operating system with an OCT probe proposed in this application does not need to extract the microcatheter from the carotid artery and then insert the OCT probe into the carotid artery. It only needs to move the microcatheter a small distance (tens of millimeters or tens of millimeters) in the carotid artery to achieve scanning and detection of the stenosis. In other words, compared with the prior art, the interventional surgery operating system with an OCT probe proposed in this application makes the two operation steps of releasing the protective umbrella and scanning and detecting the stenosis relatively simple, with low operation difficulty, and can reduce the risk borne by the patient during the operation.

[0102] Although the embodiments of the present application have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present application, and that the scope of the present application is defined by the appended claims and their equivalents.

Claims

1. An interventional surgery operating system with an OCT probe, characterized in that: include: Microcatheter (4); An OCT probe (8) is arranged at the front end of the microcatheter (4); A recovery tube (42) is arranged at the front end of the OCT probe (8); the recovery tube (42) is provided with a first through hole and a second through hole; A first control microfilament (71) and a protective umbrella (7); the front end of the first control microfilament (71) is connected to the protective umbrella (7); the front end of the first control microfilament (71) can penetrate into the interior of the recovery tube (42) through the first through hole; A micro guide wire (3); the front end of the micro guide wire (3) can penetrate into the interior of the recovery tube (42) through the second through hole.

2. The interventional surgery operating system with an OCT probe according to claim 1, characterized in that: It also includes a balloon (5); the balloon (5) and the microcatheter (4) are an integrated structure.

3. The interventional surgery operating system with an OCT probe according to claim 1, characterized in that: Also includes: A balloon (5); the balloon (5) is in a tubular structure, and the balloon (5) can be movably sleeved on the outside of the microcatheter (4); a closed cavity (51) is formed inside the balloon (5); A push catheter (6) is connected to the rear end of the balloon (5); the push catheter (6) is in communication with the sealed cavity (51).

4. The interventional surgery operating system with an OCT probe according to claim 3, characterized in that: The balloon (5) comprises: A carrier (52); the carrier (52) is a tubular structure; The film (53) is arranged outside the carrier (52); the closed cavity (51) is formed between the carrier (52) and the film (53).

5. The interventional surgery operating system with an OCT probe according to claim 4, characterized in that: The support member (52) comprises a support tube (521); guide portions (522) are provided at both ends of the support tube (521); the outer diameter of the guide portion (522) decreases along a first direction; the first direction is parallel to the axial direction of the support tube (521) and points from the guide portion (522) to the support tube (521).

6. The interventional surgery operating system with an OCT probe according to claim 5, characterized in that: The maximum outer diameter of the guide portion (522) is greater than the outer diameter of the supporting tube (521); a placement groove (523) is formed between the supporting tube (521) and the two guide portions (522); and the film (53) is stacked and arranged in the placement groove (523).

7. The interventional surgery operating system with an OCT probe according to claim 6, characterized in that: A plurality of micro titanium alloy wires (532) are arranged inside the film (53); each micro titanium alloy wire (532) is used to form elastic potential energy if the current state of the film (53) is different from the initial state, and the elastic potential energy is used to increase the tendency of the film (53) to change from the current state to the initial state.

8. The interventional surgery operating system with an OCT probe according to claim 7, characterized in that: The film (53) is stacked to form a plurality of stacked sections; each stacked section comprises at least a first stacked film (533) and a second stacked film (534); the first stacked film (533) and the second stacked film (534) are any two adjacent films in the corresponding stacked section; a plurality of connecting microcolumns (531) are arranged between each stacked section and the carrier (52), and each connecting microcolumn (531) is distributed in an axial array along the carrier (52); the fracture stress of the connecting microcolumns (531) is less than the cracking stress of the film (53); one end of each connecting microcolumn (531) is connected to the first stacked film (533), and the other end of each connecting microcolumn (531) is connected to the second stacked film (534); or, one end of each connecting microcolumn (531) is connected to the film (53), and the other end of each connecting microcolumn (531) is connected to the carrier (52).

9. The interventional surgery operating system with an OCT probe according to any one of claims 4 to 8, characterized in that: The outer diameter of the micro-catheter (4) is smaller than the inner diameter of the carrier (52); the recovery tube (42) is further provided with a limit ring (41), the limit ring (41) being close to the front end of the recovery tube (42); the maximum outer diameter of the limit ring (41) is larger than the inner diameter of the carrier (52).

10. The interventional surgery operating system with an OCT probe according to claim 9, characterized in that: Also includes: A protection tube (43); the protection tube (43) is more flexible than the recovery tube (42); The second control microfilament (45); the recovery tube (42) is also provided with a third through hole, and the front end of the second control microfilament (45) can pass through the third through hole to penetrate into the interior of the recovery tube (42); A plurality of connecting microwires (44); one end of each connecting microwire (44) is connected to the front end of the second control microwire (45), and the other end of each connecting microwire (44) is connected to the rear end of the protection tube (43).

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