Puncture sheath, micro puncture device and puncture method

Abstract

The invention relates to a puncture sheath, a micro puncture device and a puncture method. The puncture sheath comprises a sheath tube body and a plurality of expansion sheath tubes. When a guide wire with a larger diameter needs to be replaced and guided into a blood vessel in the operation process, the expansion sheathing canal of the original model does not need to be taken out firstly, and then the expansion sheathing canal of the other model corresponding to the guide wire with the larger outer diameter needing to be replaced is placed in a human body. When the puncture sheath is placed in a human body at a time, the expansion sheath tubes of different models and sizes are placed in the human body, and when guide wires of different outer diameters need to be replaced and guided into blood vessels, only the multiple expansion sheath tubes need to be detached, the expansion sheath tube with the small inner diameter is taken out, and the expansion sheath tube with the large inner diameter is left; therefore, the number of times that the puncture sheath enters a blood vessel is reduced, and the comfort level of a patient is improved.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a puncture sheath, a micropuncture device and a puncture method. Background Art

[0002] The puncture sheath has obvious advantages in reducing patient damage and reducing the risk of bleeding and hematoma. However, although the puncture sheath can reduce the risk of bleeding and hematoma, there are still certain risks, especially when the patient has a high tendency to bleed or has a complex vascular condition. Although the puncture sheath is relatively small, it may still be uncomfortable for some patients, especially for special groups such as patients who are sensitive to the puncture process or children. Summary of the invention

[0003] Based on this, the present application provides a puncture sheath, a micropuncture device and a puncture method to reduce the number of times the puncture sheath enters and exits the blood vessel and increase patient comfort.

[0004] The present application embodiment provides a puncture sheath, comprising:

[0005] A sheath body having a first channel; and

[0006] A plurality of dilatation sheath tubes, all of which have different inner diameters, so that all of the dilatation sheath tubes have a combined state capable of being set in a sleeve arrangement;

[0007] Among them, in the combined state, at least part of the expansion sheath is arranged in the first channel, the two adjacent expansion sheaths are detachably connected, and the expansion sheath with the largest inner diameter among all the expansion sheaths is detachably connected to the sheath body.

[0008] In one embodiment, the puncture sheath further includes a sheath seat and a plurality of seat bodies:

[0009] The sheath seat is connected to the distal end of the sheath body, and a plurality of seat bodies are arranged corresponding to a plurality of expansion sheaths, and the seat bodies are connected to the distal ends of the corresponding expansion sheaths;

[0010] The seat body corresponding to the expansion sheath tube with the largest inner diameter among all the expansion sheath tubes is detachably connected to the sheath seat, and the seat bodies corresponding to the two adjacent expansion sheath tubes are detachably connected.

[0011] In one embodiment, the seat body includes a first part and a second part, the first part is connected to the distal end of the corresponding dilatation sheath tube, the second part is connected to an end of the first part away from the corresponding dilatation sheath tube, the seat body has a second channel running through the first part and the second part, and the second channel of the seat body is connected to the interior of the corresponding dilatation sheath tube;

[0012] The first part has a first external thread on its outer side, and the second channel has a first internal thread on its inner side; in two adjacent expansion sheath tubes, the first internal thread of the seat body corresponding to the expansion sheath tube with a larger inner diameter matches the first external thread of the seat body corresponding to the expansion sheath tube with a smaller inner diameter; and / or

[0013] The seat body also includes a third part, the third part is connected to the first part, and the outer wall of the third part and the first part defines a receiving cavity with an opening, and the opening is arranged toward the distal end of the sheath body; in two adjacent seat bodies, at least part of the second part of the seat body corresponding to the expansion sheath with a larger inner diameter is placed in the receiving cavity of the seat body corresponding to the expansion sheath with a smaller inner diameter; and / or

[0014] The distal end of the dilatation sheath is inserted into the first part through the corresponding second channel of the seat body.

[0015] In one embodiment, the sheath seat includes a first seat portion and a second seat portion connected to each other, the first seat portion is connected to the distal end of the sheath body, and the second seat portion is connected to the seat body corresponding to the expansion sheath tube with the largest inner diameter among all the expansion sheath tubes;

[0016] wherein, along the direction from the first seat portion to the second seat portion, the cross-sectional area of ​​the first seat portion is smaller than the cross-sectional area of ​​the second seat portion; and / or

[0017] Along the direction from the first seat portion to the second seat portion, the cross-sectional area of ​​the first seat portion gradually increases; and / or

[0018] The sheath seat further comprises a reinforcing portion, a part of which is arranged on the outer side surface of the first seat portion, and another part of which is arranged on the outer side surface of the second seat portion; and / or

[0019] The sheath seat also includes a gripping portion, which is extended and arranged on the outer side surface of the second seat portion in a direction away from the central axis of the sheath tube body.

[0020] In one embodiment, the sheath seat includes a first seat portion and a second seat portion, the first seat portion is connected to the distal end of the sheath body, and the second seat portion is connected to the seat body corresponding to the expansion sheath tube with the largest inner diameter among all the expansion sheath tubes; the second seat portion includes a first sub-portion and a second sub-portion connected to each other, and the first sub-portion is connected to the first seat portion;

[0021] Wherein, along the direction from the first seat portion to the second seat portion, the cross-sectional area of ​​the first sub-portion remains unchanged; and / or

[0022] Along the direction from the first seat portion to the second seat portion, the cross-sectional area of ​​the second sub-portion is larger than the cross-sectional area of ​​the first sub-portion, and the cross-sectional area of ​​the second sub-portion increases gradually.

[0023] In one embodiment, the length of the dilatation sheath is greater than the length of the sheath body, so that the dilatation sheath passes through the first channel and the proximal end of the dilatation sheath extends out of the sheath body; and / or

[0024] Of the two adjacently sleeved dilatation sheaths, the dilatation sheath with a smaller inner diameter is longer than the dilatation sheath with a larger inner diameter, so that the proximal end of the dilatation sheath with a smaller inner diameter can extend out of the dilatation sheath with a larger inner diameter.

[0025] In one embodiment, all dilatation sheaths have an inner diameter of 0.889 mm or 0.9652 mm; and / or

[0026] All dilatation sheaths have an inner diameter of 0.3556 mm or 0.4572 mm; and / or

[0027] The outer circumference of the sheath body is 4F to 7F.

[0028] According to another aspect of the present application, an embodiment of the present application provides a micropuncture device, including the puncture sheath in any of the above embodiments and multiple guide wires, the outer diameters of all guide wires are different, the multiple guide wires are configured one-to-one with the multiple expansion sheaths, and the guide wires can be inserted into the corresponding expansion sheaths.

[0029] In one embodiment, the micropuncture device further includes a hemostatic valve, and the proximal end of either the dilation sheath or the sheath body can be detachably connected to the hemostatic valve.

[0030] According to another aspect of the present application, an embodiment of the present application provides a puncture method, comprising:

[0031] Providing a plurality of guidewires with different outer diameters, and inserting the proximal end of a target guidewire among the plurality of guidewires into a target position in a blood vessel through a puncture needle, and making the distal end of the target guidewire be located outside the blood vessel;

[0032] Based on the target guidewire, a puncture sheath in a target combination state is configured; the puncture sheath in the target combination state includes a sheath body having a first channel, and a plurality of dilatation sheaths with different inner diameters, the plurality of dilatation sheaths are configured one-to-one with the plurality of guidewires, and the guidewires can be inserted into the corresponding dilatation sheaths; in the target combination state, all dilatation sheaths are sleeved, at least part of the dilatation sheaths is arranged in the first channel, two adjacently sleeved dilatation sheaths are detachably connected, and the dilatation sheath with the largest inner diameter among all the dilatation sheaths is detachably connected to the sheath body;

[0033] The puncture sheath in the combined state is sheathed outside the target guide wire, and the puncture sheath in the combined state is pushed to the target position along the longitudinal extension direction of the target guide wire; the target guide wire is inserted into the dilation sheath tube with the smallest inner diameter in the puncture sheath in the target combined state;

[0034] The target guidewire and the dilatation sheath with the smallest inner diameter in the puncture sheath in the target combination state are withdrawn from the blood vessel to the outside of the blood vessel, and the guidewire replacement and withdrawal operation based on the dilatation sheath with the current smallest inner diameter is performed at least once until the inner diameter of the dilatation sheath with the current smallest inner diameter reaches the target inner diameter;

[0035] Among them, the guidewire replacement and withdrawal operation based on the dilatation sheath with the current smallest inner diameter includes: based on the dilatation sheath with the current smallest inner diameter and multiple guidewires, determining the current guidewire corresponding to the dilatation sheath with the current smallest inner diameter, and pushing the current guidewire through the interior of the dilatation sheath with the current smallest inner diameter to the target position, and then withdrawing the current guidewire and the dilatation sheath with the current smallest inner diameter from the blood vessel to the outside of the blood vessel.

[0036] In the above-mentioned puncture sheath, micropuncture device and puncture method, the puncture sheath includes a sheath body and multiple expansion sheaths. When it is necessary to replace a guide wire with a larger diameter to introduce it into a blood vessel during surgery, it is not necessary to take out the original type of expansion sheath first, and then place another type of expansion sheath corresponding to the guide wire with a large outer diameter that needs to be replaced into the human body. When the puncture sheath of the present application is placed in the human body once, expansion sheaths of different models and sizes are placed in the human body. When it is necessary to replace guide wires with different outer diameters to introduce them into the blood vessel, it is only necessary to disassemble the multiple expansion sheaths, take out the expansion sheath with a smaller inner diameter, and leave the expansion sheath with a larger inner diameter for use with the guide wire with a large outer diameter, thereby reducing the number of times the puncture sheath enters the blood vessel and increasing the patient's comfort. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 A schematic diagram of the structure of the puncture sheath in some embodiments of the present application is shown.

[0038] Figure 2 Shows Figure 1 Schematic diagram of the cross section of the puncture sheath at AA.

[0039] Figure 3 for Figure 2 A local enlarged view of point B.

[0040] Figure 4 Shows Figure 1 Schematic diagram of the structure of the expansion sheath in the puncture sheath when it cooperates with the sheath body.

[0041] Figure 5 A schematic diagram of the structure of a guide wire is shown.

[0042] Figure 6 A schematic structural diagram of a puncture needle is shown.

[0043] Figure 7 Schematic diagram of the structure of the hemostatic valve.

[0044] Figure 8 This is a flow chart of an embodiment of the puncture method provided by the present application.

[0045] The reference numerals in the specific implementation manner are as follows:

[0046] 100, puncture sheath, 1, sheath body, 11, distal end of sheath body 1, A1, first channel, 2, dilation sheath, 21, distal end of dilation sheath 2, 3, sheath seat, 31, first seat portion, 32, second seat portion, 321, first sub-portion, 322, second sub-portion, C, grip portion, 4, seat body, 41, first portion, 42, second portion, 43, third portion, R, accommodating cavity, A2, second channel, WL, first external thread, Q, reinforcement portion;

[0047] 101, guide wire, 102, hemostatic valve, 103, puncture needle, FM, hemostatic valve nut, CG, extension tube, FG, hemostatic valve cover, STF, three-way valve;

[0048] F1, setting direction. DETAILED DESCRIPTION

[0049] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0050] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the drawings, which is only for the convenience of describing the present application and simplifying the description, and does 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 cannot be understood as a limitation on the present application.

[0051] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0052] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0053] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0054] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only implementation method.

[0055] Reference Figure 1 , Figure 1 A schematic structural diagram of the puncture sheath 100 in some embodiments of the present application is shown. Figure 2 Shows Figure 1 Schematic cross-sectional view of the puncture sheath 100 at AA. Figure 3 for Figure 2 A partial enlarged view of point B. Figure 4 Shows Figure 1 A schematic diagram of the structure of the expansion sheath tube 2 in the puncture sheath 100 when it cooperates with the sheath body 1. The puncture sheath 100 provided in one embodiment of the present application includes a sheath body 1 and a plurality of expansion sheath tubes 2. The inner diameters of all the expansion sheath tubes 2 are different from each other, so that all the expansion sheath tubes 2 have a combined state that can be set in a sleeve; in the combined state, at least a portion of the expansion sheath tube 2 is arranged in the first channel A1.

[0056] The inner diameter of the dilatation sheath 2 can be selected according to the outer diameter of the guide wire 101. By movably cooperating two adjacent dilatation sheaths 2 along the sheathing direction F1, the pipes of all the dilatation sheaths 2 can be interconnected, and at least part of the dilatation sheath 2 is arranged in the first channel A1, that is, the pipes of the dilatation sheath 2 can be connected to the first channel A1, so that the guide wire 101 can move in the first channel A1 and the pipe.

[0057] The dilatation sheath tube 2 with the largest inner diameter among all the dilatation sheath tubes 2 is detachably connected to the sheath tube body 1; and two adjacently sleeved dilatation sheath tubes 2 are detachably connected.

[0058] By detachably connecting the sheath body 1 and the dilatation sheath 2 with the largest inner diameter, the dilatation sheath 2 can be removed from the human body after the dilatation sheath 2 is used in the operation, which is convenient for the subsequent operation. By detachably connecting at least two adjacent dilatation sheaths 2, after the dilatation sheath 2 with the smaller inner diameter assists the guide wire 101 with the smaller outer diameter to enter the human body, it can be separated from the dilatation sheath 2 with the larger inner diameter and taken out of the human body, leaving only the dilatation sheath 2 with the larger inner diameter in the human body, which is convenient for the subsequent guide wire 101 with the larger outer diameter to enter the human body.

[0059] In this way, when a larger diameter guide wire 101 needs to be replaced to introduce into a blood vessel during surgery, it is not necessary to take out the original type of dilatation sheath tube 2 first, and then place another type of dilatation sheath tube 2 corresponding to the large outer diameter guide wire 101 that needs to be replaced into the human body. When the puncture sheath 100 is placed in the human body once, dilatation sheath tubes 2 of different types and sizes are placed in the human body. When it is necessary to replace the guide wire 101 of different outer diameters to introduce into the blood vessel, it is only necessary to disassemble the multiple dilatation sheath tubes 2, take out the dilatation sheath tube 2 with a smaller inner diameter, and leave the dilatation sheath tube 2 with a larger inner diameter for use by the guide wire 101 with a larger outer diameter, thereby reducing the number of times the puncture sheath 100 enters and exits the blood vessel and increasing the patient's comfort.

[0060] In some embodiments of the present application, continue to refer to Figures 1 to 4The puncture sheath 100 further includes a sheath seat 3 and a plurality of seat bodies 4. The sheath seat 3 is connected to the distal end 11 of the sheath body 1, and the plurality of seat bodies 4 are arranged one by one corresponding to the plurality of dilatation sheaths 2, and the seat bodies 4 are connected to the distal ends 21 of the corresponding dilatation sheaths 2. The seat body 4 corresponding to the dilatation sheath 2 with the largest inner diameter among all the dilatation sheaths 2 is detachably connected to the sheath seat 3, and the seat bodies 4 corresponding to the two adjacent dilatation sheaths 2 are detachably connected.

[0061] Specifically in the present application, the sheath seat 3 and the sheath body 1 are integrally injection molded, so that the sheath seat 3 provides stable support for the sheath body 1, thereby enabling the sheath body 1 to maintain the correct position during puncture and operation, and the sheath body 1 can more easily penetrate the skin and tissue, reducing the resistance during puncture. The seat body 4 and the expansion sheath 2 are integrally injection molded, and the seat body 4 supports and fixes the expansion sheath 2, so that the expansion sheath 2 remains stable during use, improving the expansion efficiency.

[0062] In some embodiments of the present application, continue to refer to Figures 1 to 4 , Figure 2 and Figure 3 The interference position is the connection between the first external thread and the first internal thread. The seat body 4 includes a first portion 41 and a second portion 42. The first portion 41 is connected to the distal end 21 of the corresponding dilatation sheath 2, and the second portion 42 is connected to the end of the first portion 41 that is away from the corresponding dilatation sheath 2. The seat body 4 has a second channel A2 that runs through the first portion 41 and the second portion 42. The second channel A2 of the seat body 4 is connected to the interior of the corresponding dilatation sheath 2; wherein the first portion 41 has a first external thread WL on its outer surface, and the second channel A2 is located on the inner side of the second portion 42 and has a first internal thread; of the two adjacent dilatation sheaths 2, the first internal thread of the seat body 4 corresponding to the dilatation sheath 2 with a larger inner diameter is connected to the first internal thread of the seat body 4. The first external thread WL of the seat body 4 corresponding to the expansion sheath 2 with a smaller inner diameter cooperates; and / or, the seat body 4 also includes a third part 43, the third part 43 is connected to the first part 41, and the third part 43 and the outer wall of the first part 41 define a receiving cavity R with an opening, and the opening is set toward the distal end 11 of the sheath body 1; in two adjacent seat bodies 4, at least part of the second part 42 of the seat body 4 corresponding to the expansion sheath 2 with a larger inner diameter is placed in the receiving cavity R of the seat body 4 corresponding to the expansion sheath 2 with a smaller inner diameter; and / or, the distal end 21 of the expansion sheath 2 is inserted into the first part 41 via the second channel A2 of the corresponding seat body 4.

[0063] In the case where "the seat body 4 includes a first part 41 and a second part 42, the first part 41 is connected to the distal end 21 of the corresponding dilatation sheath 2, the second part 42 is connected to the end of the first part 41 away from the corresponding dilatation sheath 2, the seat body 4 has a second channel A2 that runs through the first part 41 and the second part 42, and the second channel A2 of the seat body 4 is connected to the interior of the corresponding dilatation sheath 2; wherein the first part 41 has a first external thread WL on the outer surface, and the second channel A2 is located on the inner surface of the second part 42 and has a first internal thread; in two adjacent dilatation sheaths 2, the first internal thread of the seat body 4 corresponding to the dilatation sheath 2 with a larger inner diameter cooperates with the first external thread WL of the seat body 4 corresponding to the dilatation sheath 2 with a smaller inner diameter" In this case, the first part 41 has a first external thread WL on its outer surface, and the second channel A2 is located on the inner surface of the second part 42 and has a first internal thread; in the two adjacent expansion sheaths 2, the first internal thread of the seat body 4 corresponding to the expansion sheath 2 with a larger inner diameter cooperates with the first external thread WL of the seat body 4 corresponding to the expansion sheath 2 with a smaller inner diameter, so that the two adjacent seat bodies 4 can be detachably connected, that is, the first part 41 of one of the two adjacent seat bodies 4 is threadedly connected to the second part 42 of the other seat body 4, and the two seat bodies 4 can rotate relative to each other to change their relative positions, and the threaded connection can effectively reduce the risk of loosening or falling off of the connection due to external force or operation during the operation, thereby improving the stability and safety of the instrument.

[0064] In the “seat body 4 includes a first portion 41 and a second portion 42, the first portion 41 is connected to the distal end 21 of the corresponding dilatation sheath 2, the second portion 42 is connected to the end of the first portion 41 away from the corresponding dilatation sheath 2, the seat body 4 has a second channel A2 that runs through the first portion 41 and the second portion 42, the second channel A2 of the seat body 4 is connected to the interior of the corresponding dilatation sheath 2, the seat body 4 also includes a third portion 43, the third portion 43 is connected to the first portion 41, and the outer wall of the third portion 43 and the first portion 41 defines an accommodating cavity R with an opening, and the opening faces the distal end 11 of the sheath body 1 In the case of "at least part of the second portion 42 of the seat body 4 corresponding to the expansion sheath 2 with a larger inner diameter in two adjacent seat bodies 4 is placed in the accommodating cavity R of the seat body 4 corresponding to the expansion sheath 2 with a smaller inner diameter", a nested structure is formed by placing at least part of the second portion 42 of the seat body 4 corresponding to the expansion sheath 2 with a larger inner diameter in the two adjacent seat bodies 4 in the accommodating cavity R of the seat body 4 corresponding to the expansion sheath 2 with a smaller inner diameter. This design enhances the supporting force of the seat body 4 on the expansion sheath 2 and reduces the risk of bending or deformation of the expansion sheath 2 during the expansion process. In addition, this design makes the connection between the two adjacent seat bodies 4 more tightly and reduces the risk of the two adjacent seat bodies 4 falling off during the operation of the puncture sheath 100.

[0065] In the case where "the seat body 4 includes a first part 41 and a second part 42, the first part 41 is connected to the distal end 21 of the corresponding dilatation sheath 2, the second part 42 is connected to the end of the first part 41 away from the corresponding dilatation sheath 2, the seat body 4 has a second channel A2 that runs through the first part 41 and the second part 42, the second channel A2 of the seat body 4 is connected to the interior of the corresponding dilatation sheath 2, and the distal end 21 of the dilatation sheath 2 is inserted into the first part 41 via the corresponding second channel A2 of the seat body 4", through the setting of the second channel A2, and the distal end 21 of the dilatation sheath 2 is inserted into the first part 41 via the corresponding second channel A2 of the seat body 4, the force can be transmitted step by step from the second part 42 to the first part 41, and then to the dilatation sheath 2, so that the force is evenly distributed and effectively transmitted, thereby improving the expansion efficiency.

[0066] The above-mentioned "seat body 4 includes a first part 41 and a second part 42, the first part 41 is connected to the distal end 21 of the corresponding dilatation sheath tube 2, the second part 42 is connected to the end of the first part 41 away from the corresponding dilatation sheath tube 2, the seat body 4 has a second channel A2 that runs through the first part 41 and the second part 42, and the second channel A2 of the seat body 4 is connected to the interior of the corresponding dilatation sheath tube 2; wherein, the outer surface of the first part 41 has a first external thread WL, and the second channel A2 is located on the inner side surface of the second part 42 and has a first internal thread; in two adjacent dilatation sheath tubes 2, the first internal thread of the seat body 4 corresponding to the dilatation sheath tube 2 with a larger inner diameter cooperates with the first external thread WL of the seat body 4 corresponding to the dilatation sheath tube 2 with a smaller inner diameter", "the seat body 4 includes a first part 41 and a second part 42, the first part 41 is connected to the distal end 21 of the corresponding dilatation sheath tube 2, the second part 42 is connected to the end of the first part 41 away from the corresponding dilatation sheath tube 2, and the seat body 4 has a second channel A2 that runs through the first part 41 and the second part 42 2, the second channel A2 of the seat body 4 is connected to the interior of the corresponding expansion sheath 2, the seat body 4 also includes a third part 43, the third part 43 is connected to the first part 41, the third part 43 and the outer wall of the first part 41 define a receiving cavity R with an opening, and the opening is set toward the distal end 11 of the sheath body 1; in the two adjacent seat bodies 4, at least part of the second part 42 of the seat body 4 corresponding to the expansion sheath 2 with a larger inner diameter is placed in the receiving cavity R of the seat body 4 corresponding to the expansion sheath 2 with a smaller inner diameter" and "the seat body 4 includes a first portion 41 and a second portion 42, the first portion 41 is connected to the distal end 21 of the corresponding dilatation sheath tube 2, the second portion 42 is connected to one end of the first portion 41 away from the corresponding dilatation sheath tube 2, the seat body 4 has a second channel A2 that runs through the first portion 41 and the second portion 42, the second channel A2 of the seat body 4 is connected to the inside of the corresponding dilatation sheath tube 2, and the distal end 21 of the dilatation sheath tube 2 is inserted into the first portion 41 via the second channel A2 of the corresponding seat body 4. "It can be arbitrarily combined and arranged according to actual conditions.

[0067] In some embodiments of the present application, continue to refer to Figures 1 to 4The sheath seat 3 includes a first seat portion 31 and a second seat portion 32 connected to each other, the first seat portion 31 is connected to the distal end 11 of the sheath body 1, and the second seat portion 32 is connected to the seat body 4 corresponding to the expansion sheath 2 with the largest inner diameter among all the expansion sheaths 2; wherein, along the direction from the first seat portion 31 to the second seat portion 32, the cross-sectional area of ​​the first seat portion 31 is smaller than the cross-sectional area of ​​the second seat portion 32; and / or, along the direction from the first seat portion 31 to the second seat portion 32, the cross-sectional area of ​​the first seat portion 31 gradually increases; and / or, the sheath seat 3 also includes a reinforcement portion Q, part of which is arranged on the outer side surface of the first seat portion 31, and part of which is arranged on the outer side surface of the second seat portion 32; and / or, the sheath seat also includes a gripping portion, which is extended on the outer side surface of the second seat portion in a direction away from the central axis of the sheath body.

[0068] In the case where "the sheath seat 3 includes a first seat portion 31 and a second seat portion 32 connected to each other, the first seat portion 31 is connected to the distal end 11 of the sheath body 1, and the second seat portion 32 is connected to the seat body 4 corresponding to the expansion sheath 2 with the largest inner diameter among all the expansion sheaths 2; along the direction from the first seat portion 31 to the second seat portion 32, the cross-sectional area of ​​the first seat portion 31 is smaller than the cross-sectional area of ​​the second seat portion 32", specifically in the present application, along the direction from the first seat portion 31 to the second seat portion 32, the cross-sectional area of ​​the sheath body 1 is smaller than the cross-sectional area of ​​the first seat portion 31; so the cross-sectional area of ​​the second seat portion 32 connected to the seat body 4 corresponding to the expansion sheath 2 with the largest inner diameter among all the expansion sheaths 2 along the direction from the first seat portion 31 to the second seat portion 32 is set to be larger than the cross-sectional area of ​​the first seat portion 31 connected to the sheath body 1 along the direction from the first seat portion 31 to the second seat portion 32. Along the direction from the first seat 31 to the second seat 32, the cross-sectional area of ​​the seat body 4 corresponding to the expansion sheath tube 2 with the largest inner diameter among all the expansion sheath tubes 2 is similar to the cross-sectional area of ​​the second seat 32, and the cross-sectional area of ​​the first seat 31 is similar to the cross-sectional area of ​​the sheath body 1. In this way, the stress on the components at the connection can be more evenly distributed, reducing the risk of local stress concentration, thereby improving the strength and durability of the sheath seat 3, and the seat body 4 usually needs to withstand a greater operating force. Such a design gradually transfers the load from the larger seat body 4 to the smaller sheath body, reducing the stress concentration on a single cross section, and improving the overall torsion and bending resistance.

[0069] In the case where "the sheath seat 3 includes a first seat portion 31 and a second seat portion 32 connected to each other, the first seat portion 31 is connected to the distal end 11 of the sheath body 1, and the second seat portion 32 is connected to the seat body 4 corresponding to the expansion sheath 2 with the largest inner diameter among all the expansion sheaths 2; the cross-sectional area of ​​the first seat portion 31 gradually increases along the direction from the first seat portion 31 to the second seat portion 32", the cross-sectional area of ​​the first seat portion 31 is gradually increased along the direction from the first seat portion 31 to the second seat portion 32, which can effectively disperse stress. When the puncture sheath 100 enters the human body, the resistance encountered will be dispersed along the gradually increasing cross-sectional area, reducing the risk of excessive local stress.

[0070] In the case where "the sheath seat 3 includes a first seat portion 31 and a second seat portion 32 connected to each other, the first seat portion 31 is connected to the distal end 11 of the sheath body 1, and the second seat portion 32 is connected to the seat body 4 corresponding to the expansion sheath 2 with the largest inner diameter among all the expansion sheaths 2; the sheath seat 3 also includes a reinforcement portion Q, part of which is arranged on the outer side surface of the first seat portion 31, and part of which is arranged on the outer side surface of the second seat portion 32", by providing the reinforcement portion Q, and the reinforcement portion Q is located at the position where the first seat portion 31 and the second seat portion 32 are connected, the risk of fracture between the first seat portion 31 and the second seat portion 32 is reduced, and the strength of the sheath seat 3 is further increased.

[0071] When "the sheath seat 3 includes a first seat portion 31 and a second seat portion 32 connected to each other, the first seat portion 31 is connected to the distal end 11 of the sheath body 1, and the second seat portion 32 is connected to the seat body 4 corresponding to the expansion sheath 2 with the largest inner diameter among all the expansion sheaths 2; the sheath seat 3 also includes a gripping portion C, and the gripping portion C is extended on the outer side surface of the second seat portion 32 in a direction away from the central axis of the sheath body 1", the setting of the gripping portion C makes it convenient for the operator to apply force to the sheath seat 3 when repairing or installing the sheath seat 3.

[0072] The above-mentioned "the sheath seat 3 includes a first seat portion 31 and a second seat portion 32 connected to each other, the first seat portion 31 is connected to the distal end 11 of the sheath body 1, and the second seat portion 32 is connected to the seat body 4 corresponding to the expansion sheath tube 2 with the largest inner diameter among all the expansion sheath tubes 2; along the direction from the first seat portion 31 to the second seat portion 32, the cross-sectional area of ​​the first seat portion 31 is smaller than the cross-sectional area of ​​the second seat portion 32", "the sheath seat 3 includes a first seat portion 31 and a second seat portion 32 connected to each other, the first seat portion 31 is connected to the distal end 11 of the sheath body 1, and the second seat portion 32 is connected to the seat body 4 corresponding to the expansion sheath tube 2 with the largest inner diameter among all the expansion sheath tubes 2; along the direction from the first seat portion 31 to the second seat portion 32, the cross-sectional area of ​​the first seat portion 31 gradually increases", "the sheath seat 3 includes a first seat portion 31 and a second seat portion 32 connected to each other A seat portion 31 and a second seat portion 32, the first seat portion 31 is connected to the distal end 11 of the sheath body 1, and the second seat portion 32 is connected to the seat body 4 corresponding to the expansion sheath 2 with the largest inner diameter among all the expansion sheaths 2; the sheath seat 3 also includes a reinforcement portion Q, part of the reinforcement portion Q is arranged on the outer side surface of the first seat portion 31, and part of it is arranged on the outer side surface of the second seat portion 32" and "the sheath seat 3 includes a first seat portion 31 and a second seat portion 32 connected to each other, the first seat portion 31 is connected to the distal end 11 of the sheath body 1, and the second seat portion 32 is connected to the seat body 4 corresponding to the expansion sheath 2 with the largest inner diameter among all the expansion sheaths 2; the sheath seat 3 also includes a gripping portion C, which is extended on the outer side surface of the second seat portion 32 in a direction away from the central axis of the sheath body 1" can be arbitrarily combined and arranged according to actual conditions.

[0073] In some embodiments of the present application, continue to refer to Figures 1 to 4 The sheath seat 3 includes a first seat portion 31 and a second seat portion 32 connected to each other, the first seat portion 31 is connected to the distal end 11 of the sheath body 1, and the second seat portion 32 is connected to the seat body 4 corresponding to the expansion sheath 2 with the largest inner diameter among all the expansion sheaths 2; the second seat portion 32 includes a first sub-portion 321 and a second sub-portion 322 connected to each other, the first sub-portion 321 is connected to the first seat portion 31; wherein, along the direction from the first seat portion 31 to the second seat portion 32, the cross-sectional area of ​​the first sub-portion 321 remains unchanged; and / or, along the direction from the first seat portion 31 to the second seat portion 32, the cross-sectional area of ​​the second sub-portion 322 is greater than the cross-sectional area of ​​the first sub-portion 321, and the cross-sectional area of ​​the second sub-portion 322 gradually increases.

[0074] In the case where "the sheath seat 3 includes a first seat portion 31 and a second seat portion 32 connected to each other, the first seat portion 31 is connected to the distal end 11 of the sheath body 1, and the second seat portion 32 is connected to the seat body 4 corresponding to the expansion sheath 2 with the largest inner diameter among all the expansion sheaths 2; the second seat portion 32 includes a first sub-portion 321 and a second sub-portion 322 connected to each other, and the first sub-portion 321 is connected to the first seat portion 31; wherein, along the direction from the first seat portion 31 to the second seat portion 32, the cross-sectional area of ​​the first sub-portion 321 remains unchanged", the cross-sectional area of ​​the first sub-portion 321 is set to remain unchanged, and during the pushing process, the force can be evenly distributed on the entire cross-section of the first sub-portion 321, further reducing the risk of local concentration of force, thereby improving the stability of the puncture sheath 100 when it is pushed to the lesion position. And when the sheath seat 3 needs to be disassembled for installation and maintenance, the first sub-portion 321 is convenient for the operator to hold.

[0075] In the case where "the sheath seat 3 includes a first seat portion 31 and a second seat portion 32 connected to each other, the first seat portion 31 is connected to the distal end 11 of the sheath body 1, and the second seat portion 32 is connected to the seat body 4 corresponding to the expansion sheath 2 with the largest inner diameter among all the expansion sheaths 2; the second seat portion 32 includes a first sub-portion 321 and a second sub-portion 322 connected to each other, the first sub-portion 321 is connected to the first seat portion 31, and the cross-sectional area of ​​the second sub-portion 322 is larger than the cross-sectional area of ​​the first sub-portion 321 along the direction from the first seat portion 31 to the second seat portion 32, and the cross-sectional area of ​​the second sub-portion 322 gradually increases", the sheath is usually thinner, and the sheath seat 3 needs to smoothly transition with the sheath. The gradual expansion design disperses stress through the gradual change of the cross-sectional area, reduces the risk of local stress concentration caused by sudden diameter change, and thus reduces the risk of fracture at the connection between the sheath and the sheath seat 3.

[0076] In some embodiments of the present application, continue to refer to Figures 1 to 4 , the length of the dilation sheath 2 is greater than the length of the sheath body 1, so that the dilation sheath 2 passes through the first channel A1, and the proximal end of the dilation sheath 2 extends out of the sheath body 1; and / or, among two adjacent dilation sheaths 2, the length of the dilation sheath 2 with a smaller inner diameter is greater than the length of the dilation sheath 2 with a larger inner diameter, so that the proximal end of the dilation sheath 2 with a smaller inner diameter extends out of the dilation sheath 2 with a larger inner diameter.

[0077] In the case where "the length of the dilatation sheath 2 is greater than the length of the sheath body 1, so that the dilatation sheath 2 passes through the first channel A1, and the proximal end of the dilatation sheath 2 extends out of the sheath body 1", specifically in the present application, the proximal end of the dilatation sheath 2 is a sharp tip, and the inner diameter of the dilatation sheath 2 is smaller than the inner diameter of the sheath body 1, that is, the dilatation sheath 2 is sharper than the sheath body 1. In this way, the proximal end of the dilatation sheath 2 extends out of the sheath body 1, can contact the skin or blood vessels first, can more easily penetrate the skin or blood vessels, reduce the resistance during the puncture process, and the sharp proximal end can more accurately locate the puncture point, improving the reliability of the operation.

[0078] In the case where "among two adjacent dilatation sheaths 2, the length of the dilatation sheath 2 with a smaller inner diameter is greater than the length of the dilatation sheath 2 with a larger inner diameter, so that the proximal end of the dilatation sheath 2 with a smaller inner diameter extends out of the dilatation sheath 2 with a larger inner diameter", after the puncture sheath 100 enters the human body, the dilatation sheath 2 with a smaller inner diameter is closer to the lesion location, and the channel can be pre-expanded to provide an easier entry path for the subsequent dilatation sheath 2 with a larger outer diameter.

[0079] In some embodiments of the present application, continue to refer to Figures 1 to 4 All the dilatation sheaths 2 have an inner diameter of 0.889 mm or 0.9652 mm; and / or, all the dilatation sheaths 2 have an inner diameter of 0.3556 mm or 0.4572 mm; and / or, the outer circumference of the sheath body 1 is 4F to 7F.

[0080] In the case of "all the dilatation sheath tubes 2 have an inner diameter of 0.889 mm or 0.9652 mm", when the inner diameter of the dilatation sheath tube 2 is set to 0.889 mm, it can be used for coronary artery intervention surgery, neurological intervention surgery, etc. When the inner diameter of the dilatation sheath tube 2 is set to 0.9652 mm, it can be used for transcatheter aortic valve replacement, peripheral vascular intervention surgery, and intervention surgery requiring the delivery of a larger stent, etc.

[0081] In the case of "all the dilatation sheaths 2 have an inner diameter of 0.3556 mm or 0.4572 mm", when the inner diameter of the dilatation sheath 2 is set to 0.3556 mm, it can be used for cardiac surgery, such as coronary artery intervention surgery, etc. For example, when performing stent implantation, the 0.3556 mm dilatation sheath 2 can be used in conjunction with a balloon dilator to ensure the correct placement of the stent. When the inner diameter of the dilatation sheath 2 is set to 0.4572 mm, it can be used for urological surgery, such as percutaneous nephrolithotomy, etc.

[0082] In the case of "the outer circumference of the sheath body 1 is 4F to 7F", where 1F represents a circumference of 1mm, the tube mouth diameter corresponding to the circumference of 1F is approximately 1mm / π=0.33mm. Therefore, the outer diameters of the sheath bodies 1 of 4F to 7F are 1.32mm to 2.31mm, respectively. The outer diameter of 4F is approximately 1.32mm, which is suitable for smaller blood vessel punctures and simple operations. The outer diameter of 5F is approximately 1.65mm, which is a commonly used sheath size and is suitable for most conventional operations. The outer diameter of 6F is approximately 1.98mm, providing a larger inner cavity R, which is suitable for operations that require a larger operating space. The outer diameter of 7F is approximately 2.31mm, providing the strongest support and the largest inner cavity R, which is suitable for complex lesions or operations that require high support.

[0083] In the case where "all dilatation sheaths 2 have dilatation sheaths 2 with an inner diameter of 0.889 mm, and all dilatation sheaths 2 have dilatation sheaths 2 with an inner diameter of 0.3556 mm", it can be used for coronary artery intervention surgery. When the dilatation sheaths 2 with an inner diameter of 0.889 mm and the dilatation sheaths 2 with an inner diameter of 0.3556 mm are used together, the thinner dilatation sheath 2 with an inner diameter of 0.3556 mm can be used as a tool for initial channel establishment. Its slender design can accurately pass through narrow or complex structures and reduce tissue damage. Subsequently, the sheath with an inner diameter of 0.889 mm can further expand the channel on this basis to meet the needs of larger instruments, such as balloon catheters adapted to 0.035-inch guidewires 101, to achieve a seamless transition from minimally invasive to efficient expansion.

[0084] In the case of "all dilatation sheath tubes 2 have a dilatation sheath tube 2 with an inner diameter of 0.9652 mm, and all dilatation sheath tubes 2 have a dilatation sheath tube 2 with an inner diameter of 0.4572 mm", similarly, when the dilatation sheath tube 2 with an inner diameter of 0.9652 mm and the dilatation sheath tube 2 with an inner diameter of 0.4572 mm are used together, the sheath tube with a smaller inner diameter can be used to establish a preliminary channel first to reduce the direct impact force on the tissue; then the sheath tube with a larger inner diameter can be used for further dilatation. This staged operation can reduce the risk of tissue damage caused by one-time dilatation and improve surgical safety.

[0085] According to some embodiments of the present application, continue to refer to Figures 1 to 4 , and combined with reference Figure 5 and Figure 6 , Figure 5 1 shows a schematic structural diagram of a guide wire 101, Figure 6 The structure diagram of the puncture needle 103 is shown. The embodiment of the present application provides a micro-puncture device, comprising the puncture sheath 100 and a plurality of guide wires 101 in any of the above embodiments.

[0086] In the technical solution of the embodiment of the present application, since the micropuncture device includes the puncture sheath 100 in any of the above embodiments, it also has the advantages of any of the above embodiments.

[0087] The micropuncture device includes a puncture sheath 100 and a plurality of guide wires 101 . The outer diameters of all the guide wires 101 are different from each other. The plurality of guide wires 101 are arranged in one-to-one correspondence with the plurality of dilatation sheaths 2 , and the guide wires can be inserted into the corresponding dilatation sheaths.

[0088] During the puncture operation, multiple guide wires 101 are required for different steps. The small outer diameter guide wire 101 is used for initial puncture, establishing a channel, and reducing trauma; the large outer diameter guide wire 101 is used for subsequent expansion and delivery of equipment to provide support and stability. The equipment includes a stent delivery system, a balloon catheter, and a spring coil. Such a setting can reduce complications, improve success rate, shorten operation time, etc.

[0089] In some embodiments of the present application, continue to refer to Figure 5 , among all the guide wires 101 , there is a guide wire 101 with an outer diameter of 0.889 mm or 0.9652 mm; and / or, among all the guide wires 101 , there is a guide wire 101 with an outer diameter of 0.3556 mm or 0.4572 mm.

[0090] In the case of "all guidewires 101 have guidewires 101 with an outer diameter of 0.889 mm or 0.9652 mm", the guidewire 101 can be adapted to the dilatation sheath 2 with an outer diameter of 0.889 mm or 0.9652 mm. The outer diameter of the guidewire 101 is matched with the inner diameter of the dilatation sheath 2, and the outer side of the guidewire 101 can be completely fitted with the inner side of the dilatation sheath 2.

[0091] In the case of "all guidewires 101 have guidewires 101 with an outer diameter of 0.3556 mm or 0.4572 mm", the guidewire 101 can be adapted to the dilatation sheath 2 with an outer diameter of 0.3556 mm or 0.4572 mm. Similarly, the outer diameter of the guidewire 101 is matched with the inner diameter of the dilatation sheath 2, and the outer side of the guidewire 101 can be completely fitted with the inner side of the dilatation sheath 2.

[0092] In some embodiments of the present application, the micropuncture device further includes a hemostatic valve 102 , and the proximal end of either the dilation sheath 2 or the sheath body 1 can be detachably connected to the hemostatic valve 102 .

[0093] When the hemostatic valve 102 is connected to the expansion sheath 2 in this way, the tubular cavity of the expansion sheath 2 is connected to or closed with the outside by switching the hemostatic valve 102. When the tubular cavity of the expansion sheath 2 is connected to the outside, instruments can enter the expansion sheath 2 from the outside. When the tubular cavity of the expansion sheath 2 is closed with the outside, blood can be prevented from flowing from the expansion sheath 2 to the outside.

[0094] In some embodiments of the present application, continue to refer to Figures 1 to 4 , and combined with reference Figure 7 , Figure 7 A schematic diagram of the structure of the hemostatic valve 102 is shown. The hemostatic valve 102 achieves a balance between sealing and passage of instruments through the combination of the hemostatic valve body, the hemostatic valve nut FM, the three-way valve STF and the extension tube CG. The hemostatic valve body is the main part, and an elastic sealing structure is designed inside to tightly wrap the instrument to prevent blood leakage. The hemostatic valve nut FM controls the degree of sealing by rotating to adjust the tightness of the valve body. The sealing is enhanced when tightened, and the passage of instruments is facilitated when loosened. The three-way valve STF is connected to the side of the hemostatic valve 102 and is used to inject liquid or exhaust while maintaining sealing. The extension tube CG is connected to the hemostatic valve 102 or the three-way valve and is used to extend the operating distance or connect other equipment, such as a syringe.

[0095] According to some embodiments of the present application, referring to Figure 8 , Figure 8 This is a flow chart of an embodiment of the puncture method provided by the present application. The embodiment of the present application provides a puncture method, and the puncture method includes the following steps:

[0096] S110, providing a plurality of guide wires with different outer diameters, and inserting the proximal end of a target guide wire among the plurality of guide wires into a target position in a blood vessel through a puncture needle, and making the distal end of the target guide wire be located outside the blood vessel;

[0097] S120, based on the target guidewire, configure a puncture sheath in a target combination state; the puncture sheath in the target combination state includes a sheath body having a first channel, and a plurality of dilatation sheaths with different inner diameters, the plurality of dilatation sheaths are configured one-to-one with the plurality of guidewires, and the guidewires can be inserted into the corresponding dilatation sheaths; in the target combination state, all dilatation sheaths are sleeved, at least part of the dilatation sheaths is arranged in the first channel, two adjacently sleeved dilatation sheaths are detachably connected, and the dilatation sheath with the largest inner diameter among all the dilatation sheaths is detachably connected to the sheath body;

[0098] S130, sleeve the puncture sheath in the combined state outside the target guide wire, and push the puncture sheath in the combined state to the target position along the longitudinal extension direction of the target guide wire; the target guide wire is inserted into the dilation sheath tube with the smallest inner diameter in the puncture sheath in the target combined state;

[0099] S140, withdrawing the target guidewire and the dilatation sheath tube with the smallest inner diameter in the puncture sheath in the target combination state from the blood vessel to the outside of the blood vessel, and performing guidewire replacement and withdrawal operations based on the dilatation sheath tube with the current smallest inner diameter at least once, until the inner diameter of the dilatation sheath tube with the current smallest inner diameter reaches the target inner diameter;

[0100] Among them, the guidewire replacement and withdrawal operation based on the dilatation sheath with the current smallest inner diameter includes: based on the dilatation sheath with the current smallest inner diameter and multiple guidewires, determining the current guidewire corresponding to the dilatation sheath with the current smallest inner diameter, and pushing the current guidewire through the interior of the dilatation sheath with the current smallest inner diameter to the target position, and then withdrawing the current guidewire and the dilatation sheath with the current smallest inner diameter from the blood vessel to the outside of the blood vessel.

[0101] In step S110, tools required for puncture surgery, puncture sheath 100 and multiple guide wires 101 are provided, and the outer diameters of all guide wires 101 are different from each other. The head of the thinner guide wire 101 is softer and can pass through the circuitous blood vessels and the narrow lesions, while the thicker guide wire 101 can play a supporting role. The thicker guide wire 101, due to its larger diameter, can better maintain its shape when encountering external forces such as the bending, stenosis or squeezing of other tissues of the blood vessels, and is not prone to excessive bending, twisting or breaking. For example, in coronary artery intervention, there are many bends and corners in the heart and blood vessels. The thicker guide wire 101 can maintain a relatively straight shape when passing through these parts, providing a stable track for subsequent catheters and other instruments to pass. First, a thinner target guide wire 101 is taken, and the target guide wire 101 enters the blood vessel for exploration first. The doctor observes the progress of the thin guide wire 101 to understand the patency of the blood vessel, the presence or absence of lesions such as stenosis or obstruction, and evaluate the parameters such as the diameter and curvature of the blood vessel. Based on the feedback information from the thin guide wire 101, the doctor can more accurately select appropriate follow-up treatment plans and equipment, such as determining whether further blood vessel dilation is needed and what size of stent to choose.

[0102] In step S120, according to the outer diameter of the guide wire 101 required in the operation, the expansion sheath tube of the corresponding model to the guide wire is combined so that the puncture sheath is in the target combination state, and the sheath body 1 and the expansion sheath tube 2 with the largest inner diameter are detachably connected, so that after the expansion sheath tube 2 is used in the operation, the expansion sheath tube 2 can be taken out of the human body, which is convenient for subsequent surgical operations. By detachably connecting at least two adjacent expansion sheath tubes 2, after the expansion sheath tube 2 with a smaller inner diameter assists the guide wire 101 with a smaller outer diameter to enter the human body, it can be separated from the expansion sheath tube 2 with a larger inner diameter and taken out of the human body, leaving only the expansion sheath tube 2 with a larger inner diameter in the human body, which is convenient for the subsequent guide wire 101 with a larger outer diameter to enter the human body.

[0103] It is understandable that step S110 and step S120 are only for convenience of description, and the order is not emphasized. Step S110 can be performed first or step S120 can be taken first.

[0104] In step S130, the target guidewire 101 has reached the target position, and the dilatation sheath 2 is placed on the target guidewire 101 and can move strictly along the trajectory of the guidewire 101, so that the dilatation sheath 2 can accurately reach the expected vascular lesion. The dilatation sheath 2 has a certain diameter and hardness, and can apply uniform pressure to the blood vessel wall during the pushing process, so that the inner diameter of the blood vessel is expanded, and a sufficiently spacious channel is opened for subsequent interventional devices to enter the blood vessel. Especially in the case of vascular stenosis or lesions, the stenosis can be effectively expanded. For example, when treating peripheral vascular stenosis, it creates conditions for the smooth passage of balloon catheters, stents and other devices.

[0105] In step S140, the target guide wire 101 has completed the role of guiding the puncture sheath 100 into the lesion position, and the target guide wire 101 is withdrawn from the blood vessel, and the expansion sheath 2 adapted to the target guide wire 101 is separated from the other parts of the puncture sheath 100 and withdrawn from the blood vessel. It can be understood that at this time, the expansion sheath 2 of other sizes is retained in the blood vessel, and the minimum size of the channel established in the puncture sheath 100 at this time is the size of the expansion sheath 2 of the smallest size. It is convenient for the subsequent guide wire 101 of other sizes to reach the lesion position with the help of the expansion sheath 2.

[0106] Select a guidewire 101 with an outer diameter larger than the target guidewire 101, and push it to the target position along the lumen of the dilatation sheath 2 corresponding to the guidewire 101, and after the thicker guidewire 101 enters the blood vessel, withdraw the dilatation sheath 2 corresponding to the guidewire 101 outside the blood vessel, and leave the dilatation sheath 2 corresponding to the subsequent guidewire 101 in the blood vessel to prepare for the subsequent guidewire 101 to enter. Gradually using thicker guidewires 101 and sheaths can gradually expand the vascular access, reduce sudden pressure on the vascular wall, and thus reduce the risk of vascular damage or rupture. Keeping the current puncture sheath 100 in the blood vessel each time it is replaced helps to maintain the stability of the access, reduce the number of times the puncture sheath 100 enters and exits the blood vessel, not only saving time but also reducing complications. Until the inner diameter of the dilatation sheath 2 with the current smallest inner diameter is the target inner diameter, all dilatation sheaths 2 are withdrawn from the blood vessel, and only the last guidewire 101 and sheath body 1 are retained in the blood vessel. In this way, when subsequent instruments enter the blood vessel, the guide wire 101 can maintain a relatively straight shape, providing a stable track for the passage of subsequent instruments such as catheters.

[0107] The guidewire 101 replacement and withdrawal operation based on the current minimum inner diameter of the dilatation sheath 2 also includes:

[0108] The hemostatic valve 102 is matched with the expansion sheath 2 with the current minimum inner diameter and the hemostatic valve 102. The hemostatic valve 2 is in an open state, and the lumen of the expansion sheath 2 is connected to the outside. The hemostatic valve 102 is in a closed state, and the lumen of the expansion sheath is not connected to the outside. The outer diameter of the guide wire 101 entering the blood vessel is getting larger and larger. If it is not sealed, the pressure in the blood vessel may cause the blood to continue to flow out, which will not only affect the surgical field of view, but also may cause the patient to lose too much blood and endanger his life. In addition, the hemostatic valve 102 also provides a controllable environment for the subsequent possible entry and exit of instruments. When the doctor needs to introduce other instruments again through the expansion sheath 2, such as a catheter or a guide wire 101 for further treatment operations, the valve body of the hemostatic valve 102 can adjust the opening and closing degree during the entry and exit of the instrument, which not only ensures that the instrument can pass smoothly, but also minimizes the overflow of blood to ensure the smooth progress of the operation.

[0109] After the current guide wire 101 and the current expansion sheath tube 2 with the smallest inner diameter are withdrawn from the blood vessel to the outside of the blood vessel, the following steps are also included: the hemostatic valve 102 is matched with the sheath tube body 1, the hemostatic valve 2 is in an open state, the first channel A1 of the sheath tube body 1 is connected to the outside, and the hemostatic valve 102 is in a closed state, and the first channel A1 of the tube body 1 is not connected to the outside. Similarly, during the operation, after the sheath tube body 1 is inserted into the human blood vessel, a channel for blood to communicate with the outside will be formed. After the valve body of the hemostatic valve 102 is connected, it can be tightly closed to prevent blood from flowing out from the connection between the sheath tube body 1 and the outside, maintain the stability of the blood volume in the patient's body, and reduce the risk of serious consequences such as hypotension and shock caused by excessive blood loss.

[0110] The technical features of the above embodiments may be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0111] The above embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. A puncture sheath, characterized in that: include: The sheath body has a first channel; and A plurality of dilatation sheath tubes, all of which have different inner diameters, so that all of the dilatation sheath tubes have a combined state capable of being set in a sleeve arrangement; Among them, in the combined state, at least part of the dilatation sheath is arranged in the first channel, the two adjacent dilatation sheaths are detachably connected, and the dilatation sheath with the largest inner diameter among all the dilatation sheaths is detachably connected to the sheath body.

2. The puncture sheath according to claim 1, characterized in that: The puncture sheath also includes a sheath seat and a plurality of seat bodies: The sheath seat is connected to the distal end of the sheath body, the plurality of seats are arranged in one-to-one correspondence with the plurality of dilatation sheaths, and the seat is connected to the distal end of the corresponding dilatation sheath; The seat body corresponding to the dilatation sheath tube having the largest inner diameter among all the dilatation sheath tubes is detachably connected to the sheath seat, and the seat bodies corresponding to two adjacent dilatation sheath tubes are detachably connected.

3. The puncture sheath according to claim 2, characterized in that: The seat body comprises a first part and a second part, the first part is connected to the distal end of the corresponding dilatation sheath tube, the second part is connected to an end of the first part away from the corresponding dilatation sheath tube, the seat body has a second channel running through the first part and the second part, and the second channel of the seat body is connected to the interior of the corresponding dilatation sheath tube; Wherein, the first part has a first external thread on its outer side surface, and the second channel has a first internal thread on its inner side surface; of the two adjacent expansion sheath tubes, the first internal thread of the seat body corresponding to the expansion sheath tube with a larger inner diameter matches the first external thread of the seat body corresponding to the expansion sheath tube with a smaller inner diameter; and / or The seat body also includes a third part, the third part is connected to the first part, and the outer wall of the third part and the first part defines a receiving cavity with an opening, and the opening is arranged toward the distal end of the sheath body; in two adjacent seat bodies, at least part of the second part of the seat body corresponding to the dilatation sheath with a larger inner diameter is placed in the receiving cavity of the seat body corresponding to the dilatation sheath with a smaller inner diameter; and / or The distal end of the dilatation sheath is inserted into the first portion through the corresponding second channel of the seat body.

4. The puncture sheath according to claim 2, characterized in that: The sheath seat comprises a first seat portion and a second seat portion connected to each other, the first seat portion is connected to the distal end of the sheath body, and the second seat portion is connected to the seat body corresponding to the dilatation sheath tube having the largest inner diameter among all the dilatation sheath tubes; wherein, along a direction from the first seat portion to the second seat portion, a cross-sectional area of ​​the first seat portion is smaller than a cross-sectional area of ​​the second seat portion; and / or Along the direction from the first seat portion to the second seat portion, the cross-sectional area of ​​the first seat portion gradually increases; and / or The sheath seat further comprises a reinforcing portion, a portion of which is disposed on the outer side surface of the first seat portion, and another portion of which is disposed on the outer side surface of the second seat portion; and / or The sheath seat further comprises a gripping portion, which is extended on the outer side surface of the second seat portion in a direction away from the central axis of the sheath tube body.

5. The puncture sheath according to claim 2, characterized in that: The sheath seat comprises a first seat portion and a second seat portion, the first seat portion is connected to the distal end of the sheath body, and the second seat portion is connected to the seat body corresponding to the dilatation sheath tube with the largest inner diameter among all the dilatation sheath tubes; the second seat portion comprises a first sub-portion and a second sub-portion connected to each other, and the first sub-portion is connected to the first seat portion; Wherein, along the direction from the first seat portion to the second seat portion, the cross-sectional area of ​​the first sub-portion remains unchanged; and / or Along the direction from the first seat portion to the second seat portion, the cross-sectional area of ​​the second sub-portion is larger than the cross-sectional area of ​​the first sub-portion, and the cross-sectional area of ​​the second sub-portion gradually increases.

6. The puncture sheath according to any one of claims 1 to 5, characterized in that: The length of the dilatation sheath is greater than the length of the sheath body, so that the dilatation sheath passes through the first channel and the proximal end of the dilatation sheath extends out of the sheath body; and / or Of the two adjacently arranged dilatation sheaths, the dilatation sheath with a smaller inner diameter is longer than the dilatation sheath with a larger inner diameter, so that the proximal end of the dilatation sheath with a smaller inner diameter can extend out of the dilatation sheath with a larger inner diameter.

7. The puncture sheath according to any one of claims 1 to 5, characterized in that: All the dilatation sheaths have an inner diameter of 0.889 mm or 0.9652 mm; and / or All the dilatation sheath tubes have an inner diameter of 0.3556 mm or 0.4572 mm; and / or The outer circumference of the sheath body is 4F to 7F.

8. A micropuncture device, characterized in that: It comprises the puncture sheath as described in any one of claims 1 to 8 and a plurality of guide wires, the outer diameters of all the guide wires are different from each other, the plurality of guide wires are arranged in one-to-one correspondence with the plurality of dilatation sheaths, and the guide wires can be inserted into the corresponding dilatation sheaths.

9. The micropuncture device according to claim 8, characterized in that: The micropuncture device further comprises a hemostatic valve, and the proximal end of either the dilation sheath or the sheath body can be detachably connected to the hemostatic valve.

10. A puncture method, characterized in that: include: Providing a plurality of guidewires with different outer diameters, and inserting the proximal end of a target guidewire among the plurality of guidewires into a target position in a blood vessel through a puncture needle, and making the distal end of the target guidewire be located outside the blood vessel; Based on the target guidewire, a puncture sheath in a target combination state is configured; the puncture sheath in the target combination state includes a sheath body having a first channel, and a plurality of dilatation sheaths with different inner diameters, the plurality of dilatation sheaths are configured one-to-one with the plurality of guidewires, and the guidewires can be inserted into the corresponding dilatation sheaths; in the target combination state, all the dilatation sheaths are sleeved, at least part of the dilatation sheaths is arranged in the first channel, two adjacently sleeved dilatation sheaths are detachably connected, and the dilatation sheath with the largest inner diameter among all the dilatation sheaths is detachably connected to the sheath body; The puncture sheath in the combined state is sleeved outside the target guide wire, and the puncture sheath in the combined state is pushed to the target position along the longitudinal extension direction of the target guide wire; the target guide wire is inserted into the dilation sheath tube with the smallest inner diameter in the puncture sheath in the target combined state; The target guidewire and the dilatation sheath tube with the smallest inner diameter in the puncture sheath in the target combination state are withdrawn from the blood vessel to the outside of the blood vessel, and the guidewire replacement and withdrawal operation based on the dilatation sheath tube with the current smallest inner diameter is performed at least once until the inner diameter of the dilatation sheath tube with the current smallest inner diameter reaches the target inner diameter; Among them, the guidewire replacement and withdrawal operation based on the dilatation sheath with the current smallest inner diameter includes: based on the dilatation sheath with the current smallest inner diameter and the multiple guidewires, determining the current guidewire corresponding to the dilatation sheath with the current smallest inner diameter, and pushing the current guidewire through the interior of the dilatation sheath with the current smallest inner diameter to the target position, and then withdrawing the current guidewire and the dilatation sheath with the current smallest inner diameter from the blood vessel to the outside of the blood vessel.

Images