Vascular sheath capable of changing interventional operation direction

Abstract

The vascular sheath capable of changing the interventional operation direction comprises a hollow outer sheath, a first channel extending in the axial direction of the outer sheath is formed in the outer sheath, openings are formed in the head end and the tail end of the outer sheath, and the first channel is communicated with the openings in the head end and the tail end to form a passage in the first direction; a second channel is further constructed on the sheath wall of the outer sheath and comprises a straight line section and a turning section, the straight line section extends in the axial direction of the outer sheath, the turning section extends in the wall thickness direction of the outer sheath in a bent mode to change the direction, one end of the turning section is communicated with the straight line section, and the other end of the turning section extends to be exposed out of the outer sheath after being bent and turned. An opening in the tail end of the outer sheath is communicated with the second channel to form a passage in the second direction; a guide wire penetrates through the passage in the second direction; the vascular sheath can change the operation direction during an operation and treat multiple lesions at the same time, so that the operation time and frequency can be reduced, the occurrence rate of postoperative puncture related complications is reduced, and the economic burden of a patient is relieved.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a vascular sheath capable of changing the direction of interventional operation. Background Art

[0002] The vascular sheath mainly includes a puncture needle, a short guide wire, an inner sheath (sheath core) and an outer sheath. During surgery, the inner sheath needs to be assembled into the outer sheath, and the puncture needle is used to puncture into the blood vessel. After the short guide wire is introduced, the puncture needle is withdrawn, and then the vascular sheath is inserted into the blood vessel along the short guide wire. Finally, the short guide wire and the inner sheath are withdrawn together. After that, all intracavitary interventional surgical operations and treatment devices are introduced into the diseased blood vessel through the vascular guide sheath. At present, the vascular sheaths commonly used internationally and domestically are all unidirectional sheaths, that is, catheters, balloons, stents and other treatment devices can only be introduced in one direction, so basically only one arterial lesion can be treated in one direction.

[0003] Due to its advantages of less trauma, quick recovery and wide application range, endovascular interventional treatment technology has developed rapidly in the past two decades and has been widely used in the diagnosis and treatment of peripheral arterial disease, especially lower limb arteriosclerosis obliterans. It has brought the possibility of treatment to patients with contraindications to open surgery, such as advanced age, poor physical condition and inability to tolerate major surgery, and has achieved relatively remarkable results in clinical practice.

[0004] However, with the widespread application of intravascular interventional technology, the problems associated with it are also increasing. Among them, the most prominent is the problem of lesion location and surgical operation direction in lower extremity arteriosclerosis occlusive disease. When performing intravascular surgery, it is usually necessary to pre-place a vascular sheath in the puncture access vessel, and deliver specialized therapeutic devices such as catheters, balloons, and stents to the lesion site through the guide sheath. Lower extremity artery surgery generally chooses to puncture the femoral artery, with iliac artery lesions upward and femoropopliteal and infrapopliteal artery lesions downward. At present, more and more patients need to treat multiple lesions at the proximal and head ends at the same time. However, since the vascular sheaths currently used internationally and domestically are all unidirectional sheaths, that is, therapeutic devices such as catheters, balloons, and stents can only be introduced in one direction, basically only one arterial lesion can be treated in one direction.

[0005] Since there is no dedicated medical device to change the direction of the vascular sheath, if the direction of the surgical operation needs to be changed, the current method is to only treat one arterial lesion in this operation, and then perform a second or multiple operations at a later date to treat other lesions, or puncture the contralateral femoral artery to treat other lesions. This not only increases the difficulty of the operation, prolongs the operation time, and makes it difficult for patients to tolerate, but may also lead to postoperative complications such as vascular bleeding at the puncture site, femoral artery pseudoaneurysm, and femoral arteriovenous fistula, which increases the patient's pain, and also increases the patient's economic burden and corresponding medical and health care expenses.

[0006] Therefore, the above-mentioned prior art has at least the following technical problems: in the prior art, when the surgical operation direction needs to be changed during intravascular interventional surgery, the operation can only be performed twice or more at a later time, which increases the difficulty of the operation, prolongs the operation time, and increases the burden on patients. Utility Model Content

[0007] The embodiment of the present application provides a vascular sheath that can change the direction of interventional operation, thereby solving the technical problem in the prior art that when the direction of surgical operation needs to be changed during intravascular interventional surgery, only a second or multiple operations can be performed at a later date, which increases the difficulty of the operation, prolongs the operation time, and increases the burden on patients.

[0008] In order to solve the above technical problems, the embodiment of the present application provides a vascular sheath capable of changing the direction of interventional operation, characterized in that the vascular sheath comprises a hollow outer sheath, a first channel extending along the axial direction of the outer sheath is formed therein, and the head end and the tail end of the outer sheath are both open, and the first channel is connected to the openings of the head end and the tail end to form a passage along a first direction;

[0009] A second channel is also constructed on the sheath wall of the outer sheath, and the second channel includes a straight section and a turning section, wherein the straight section extends along the axial direction of the outer sheath, and the turning section bends and extends along the wall thickness direction of the outer sheath to change direction, and one end of the turning section is connected to the straight section, and the other end is bent and turned and then extends to be exposed outside the outer sheath, and the tail end opening of the outer sheath is connected to the second channel to form a passage along the second direction;

[0010] Wherein, a guide wire runs through the passage along the second direction.

[0011] Furthermore, the turning section is in the shape of an arc hole, and the central angle of the turning section is 180°.

[0012] Furthermore, the straight line segment is a groove arranged on the inner wall of the outer sheath.

[0013] Furthermore, the turning section is also connected to a guide tube, one end of which is inserted into and connected to the turning section, and the other end of which passes through the wall surface of the outer sheath and extends toward the tail end of the outer sheath;

[0014] The guide wire passes through the tail end opening of the outer sheath and the second channel, turns, and then passes through the guide tube to pass through the outer sheath.

[0015] Furthermore, the outer sheath is also connected to an injection tube, and the injection tube is communicated with the first channel.

[0016] Furthermore, a marker point for indicating the position of the guide tube is provided on the outer wall surface of the outer sheath.

[0017] Furthermore, the marker point is aligned with the outlet end of the guide tube along the radial direction of the outer sheath.

[0018] Furthermore, the marker points are arranged in a circle along the circumference of the outer sheath.

[0019] Furthermore, the vascular sheath also includes an inner sheath, which can pass through the first channel, wherein the front end of the inner sheath is a pointed tip and the head end of the outer sheath is a flat head, so as to facilitate guiding the outer sheath into the blood vessel.

[0020] Furthermore, the distance between the turning section and the head end of the outer sheath is 5 cm.

[0021] One or more technical solutions provided in the embodiments of the present application have at least the following technical effects or advantages:

[0022] (1) The vascular sheath described in the embodiment of the present application is provided with a passage along the second direction on the sheath wall of the outer sheath, and a guide wire is reserved in the passage in the second direction. When the operation direction needs to be changed during the intravascular interventional surgery, the original ordinary vascular sheath is withdrawn, and the original guide wire of the ordinary vascular sheath is retained. The passage along the first direction of the vascular sheath described in the embodiment of the present application is inserted into the original guide wire, and the vascular sheath described in the embodiment of the present application is sent into the blood vessel along the original guide wire, and then the outer sheath is fixed, and then the original guide wire and the outer sheath described in the embodiment of the present application are withdrawn in turn, that is, the guide wire reserved in the passage along the second direction is sent to the designated position. Since the second direction is different from the first direction, the interventional operation direction is changed. The technical problem that the prior art relies on manual finger function training for patients is not only limited to the training occasion, but also inefficient and cannot meet the technical problem of demand. The vascular sheath described in the embodiment of the present application can be used to perform intravascular surgery on patients with bilateral femoral artery lesions, concurrent ipsilateral iliac artery and infrapopliteal artery lesions, etc. The use of the vascular sheath can change the operation direction during surgery, treat multiple lesions at the same time, reduce surgery time and number, reduce the incidence of postoperative puncture-related complications, and reduce the economic burden on patients.

[0023] (2) The central angle of the turning section is 180°, which is set to make the second direction as opposite to the first direction as possible, thereby having a larger turning angle to meet surgical needs.

[0024] (3) The turning section is also connected to a guide tube, which can further guide the front end of the guide wire to extend toward the rear end of the outer sheath, so as to maximize the second direction and

[0025] The first direction is opposite and has a larger turning angle to meet surgical needs.

[0026] (4) Marker points for indicating the position of the guide tube are provided on the outer wall surface of the outer sheath, and the marker points are arranged in a circle along the circumference of the outer sheath so as to be observed from all directions. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the embodiments of the utility model or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the utility model. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0028] Figure 1 The overall structure of the outer sheath in one embodiment of the utility model is shown in FIG. Figure 1 ;

[0029] Figure 2 The overall structure of the outer sheath in one embodiment of the utility model is shown in FIG. Figure 2 ;

[0030] Figure 3 A cross-sectional view of an outer sheath in one embodiment of the utility model;

[0031] Figure 4 The overall structure of a vascular sheath capable of changing the direction of interventional operation in one embodiment of the utility model is shown in FIG. Figure 1 ;

[0032] Figure 5 The overall structure of a vascular sheath capable of changing the direction of interventional operation in one embodiment of the utility model is shown in FIG. Figure 2 ;

[0033] Figure 6 It is a front view of a vascular sheath capable of changing the direction of interventional operation in one embodiment of the utility model. DETAILED DESCRIPTION

[0034] The embodiment of the present application provides a vascular sheath that can change the direction of interventional operation, thereby solving the technical problem in the prior art that when the direction of surgical operation needs to be changed during intravascular interventional surgery, only a second or multiple operations can be performed at a later date, which increases the difficulty of the operation, prolongs the operation time, and increases the burden on patients.

[0035] In order to better understand the above technical solution, the above technical solution will be described in detail below in conjunction with the accompanying drawings and specific implementation methods.

[0036] Since the puncture point is generally selected at the femoral artery during intravascular interventional surgery, in order to meet the need to simultaneously treat proximal iliac artery lesions and distal femoropopliteal and infrapopliteal artery lesions during the interventional surgery, one or more embodiments of the present application provide a vascular sheath that can change the direction of the interventional operation, which is used to change the direction of the surgical operation during intravascular interventional surgery.

[0037] like Figures 1 to 6 As shown, the vascular sheath includes a hollow outer sheath 100, the outer sheath 100 body is in the shape of a hollow cylinder, a first channel 130 extending along the axial direction of the outer sheath 100 is formed therein, and the head end 120 and the tail end 110 of the outer sheath 100 are both open, and the first channel 130 is connected to the openings of the head end 120 and the tail end 110 to form a passage along a first direction;

[0038] A second channel is also constructed on the sheath wall of the outer sheath 100, and the second channel includes a straight section 141 and a turning section 142, wherein the straight section 141 extends along the axial direction of the outer sheath 100, and the turning section 142 bends and extends along the wall thickness direction of the outer sheath 100 to change direction, and one end of the turning section 142 is connected to the straight section 141, and the other end is bent and turned and then extends to be exposed to the outer sheath 100, and the tail end 110 opening of the outer sheath 100 is connected to the second channel to form a passage along the second direction;

[0039] A guide wire 160 runs through the passage along the second direction.

[0040] It can be known from the above description that the vascular sheath described in the embodiment of the present application is provided with a passage along the second direction on the sheath wall of the outer sheath 100, and a guide wire 160 is reserved in the passage in the second direction. When the operation direction needs to be changed during the intravascular interventional surgery, the original ordinary vascular sheath is withdrawn, and the original guide wire of the ordinary vascular sheath is retained, and the passage along the first direction of the vascular sheath described in the embodiment of the present application is inserted into the original guide wire, and the vascular sheath described in the embodiment of the present application is sent into the blood vessel along the original guide wire, and then the outer sheath 100 is fixed, and then the original guide wire and the outer sheath 100 described in the embodiment of the present application are withdrawn in turn, that is, the guide wire 160 reserved in the passage along the second direction is sent to the designated position, and because the second direction is different from the first direction, the interventional operation direction is changed. The technical problem that the prior art relies on manual finger function training for patients is not only limited to the training occasion, but also inefficient and cannot meet the technical problem of demand.

[0041] Therefore, the vascular sheath described in the embodiment of the present application can be used to perform intravascular surgery on patients with bilateral femoral artery lesions, combined with ipsilateral iliac artery and infrapopliteal artery lesions, etc. By using this vascular sheath, the operation direction can be changed during surgery, and multiple lesions can be treated at the same time, reducing the operation time and number, reducing the incidence of postoperative puncture-related complications, and alleviating the economic burden on patients.

[0042] In addition, it should be noted that the guide wire 160 is a bendable soft guide wire 160, so as to facilitate passing through the passage along the second direction.

[0043] In one embodiment of the present application, Figure 3 As shown, the turning section is in an arc hole shape, and the center angle of the turning section 142 is 180°, which is set to make the second direction opposite to the first direction as much as possible, so as to have a larger turning angle to meet the needs of surgery. Of course, the center angle of the turning section 142 can also be other sizes to meet the specific turning angle.

[0044] In one embodiment of the present application, Figure 3 As shown, the straight section 141 is a groove arranged on the inner wall of the outer sheath 100. Such arrangement can retain the guide wire 160 and facilitate the separation of the guide wire 160 inside the outer sheath 100 when it is withdrawn after being inserted into the blood vessel, thereby facilitating the withdrawal of the outer sheath 100.

[0045] In one embodiment of the present application, Figures 1 to 6 As shown, the turning section 142 is also connected to a guide tube 150, one end of the guide tube 150 is inserted into the turning section 142 and connected, and the other end passes through the wall of the outer sheath 100 and extends toward the tail end 110 of the outer sheath 100, and the tail end 110 of the outer sheath 100 is opened, the second channel and the guide tube 150 are connected to form the passage along the second direction, and the guide wire 160 penetrates from the tail end 110 of the outer sheath 100 and the second channel, turns, and then passes through the guide tube 150 to exit the outer sheath 100.

[0046] Specifically, the guide tube 150 can further guide the front end of the guide wire 160 to extend toward the rear end 110 of the outer sheath 100 , so as to make the second direction opposite to the first direction as much as possible and have a larger turning angle to meet surgical needs.

[0047] In one embodiment of the present application, the guide tube 150 is a hose, and the length of the hose is 1 cm.

[0048] In one embodiment of the present application, Figures 1 to 6As shown, the outer sheath 100 is also connected to an injection tube 180 , and the injection tube 180 is in communication with the first channel 130 . Specifically, contrast agent can be injected through the injection tube 180 and the outer sheath 100 .

[0049] Furthermore, a switch valve 181 is provided on the injection pipe 180, so that the opening or closing of the injection pipe 180 can be controlled.

[0050] In one embodiment of the present application, Figures 1 to 6 As shown, a marker point 170 for indicating the position of the guide tube 150 is provided on the outer wall surface of the outer sheath 100 , and the marker point 170 is aligned with the outlet end of the guide tube 150 along the radial direction of the outer sheath 100 .

[0051] Specifically, a marker point, also known as a marking point, is a distinct and easily identifiable point set by a doctor on a medical image. This point is usually set to help doctors more accurately locate the lesion, track the development of the lesion, or assist in navigation of surgical operations. The marker point can be formed by injecting a contrast agent, or it can be a mark made on the outer wall of the outer sheath 100 using an external device (such as a marking pen on an X-ray machine).

[0052] When angiography shows that the marker point 170 is within the contrast agent development range, it indicates that the guide tube 150 is within the blood vessel. At this time, pushing the guide wire 160 in can reach a direction different from or opposite to the initial operation position. After DSA (Digital Subtraction Angiography) confirms that the guide wire 160 has reached a certain distance in the opposite direction, the guide wire 160 is retained, the outer sheath 100 is withdrawn, and the corresponding instrument is replaced to proceed to the next step.

[0053] In one embodiment of the present application, the marker points 170 are arranged in a circle along the circumference of the outer sheath 100 so as to be easily observed from any direction.

[0054] In one embodiment of the present application, Figures 4 to 6 As shown, the vascular sheath also includes an inner sheath 200, which can penetrate the first channel 130, wherein the front end of the inner sheath 200 is a pointed end 210, and the head end 120 of the outer sheath 100 is a flat head, so as to facilitate guiding the outer sheath 100 into the blood vessel.

[0055] In addition, the hardness of the inner sheath 200 is lower than that of the outer sheath 100 to avoid damaging blood vessels.

[0056] In one embodiment of the present application, the distance between the turning section 142 and the head end 120 of the outer sheath 100 is 5 cm.

[0057] An exemplary method of using a vascular sheath capable of changing the direction of an interventional operation provided in an embodiment of the present application is as follows:

[0058] When the operation direction needs to be changed during the intravascular interventional surgery, the common vascular sheath operated along the first direction is withdrawn and the original guide wire of the common vascular sheath is retained; the inner sheath 200 described in the embodiment of the present application is inserted into the outer sheath 100 to assemble the vascular sheath described in the embodiment of the present application, and then the vascular sheath described in the embodiment of the present application is sent into the blood vessel along the original guide wire and the outer sheath 100 described in the embodiment of the present application is fixed;

[0059] Next, the original guide wire is withdrawn together with the inner sheath 200 described in the embodiment of the present application. After the inner sheath 200 described in the embodiment of the present application is withdrawn, the outer sheath 100 described in the embodiment of the present application is slowly withdrawn. At the same time, a contrast agent is injected through the outer sheath 100 described in the embodiment of the present application to perform angiography. When the angiography shows that the marker point 170 on the outer sheath 100 described in the embodiment of the present application is located within the contrast agent development range, it indicates that the guide tube 150 described in the embodiment of the present application is already located in the blood vessel. At this time, the guide wire 160 reserved in the passage along the second direction is pushed in to reach the direction opposite to the initial operation position.

[0060] After DSA confirms that the guide wire 160 described in the embodiment of the present application reaches a certain distance in the opposite direction, the guide wire 160 is retained, and the outer sheath 100 described in the embodiment of the present application is withdrawn, and the corresponding instrument is replaced to perform the operation.

[0061] It should be understood that although the terms "first", "second", etc. may be used herein to describe various units, these units should not be limited by these terms. These terms are used only to distinguish one unit from another. For example, a first unit may be referred to as a second unit, and similarly, a second unit may be referred to as a first unit without departing from the scope of the exemplary embodiments.

[0062] The directional terms such as outer, middle, inner, etc. mentioned or may be mentioned in this specification are defined relative to the structures shown in the drawings. They are relative concepts and may change accordingly according to different positions and different usage conditions. Therefore, these or other directional terms should not be interpreted as restrictive terms.

[0063] The above is only a preferred embodiment of the present application, and is not any formal or substantial limitation to the present application. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the method of the present application, and these improvements and supplements should also be regarded as the protection scope of the present utility model. Any technician familiar with this profession can make some changes, modifications and evolutions of the technical content disclosed above without departing from the spirit and scope of the present application, which are equivalent embodiments of the present application; at the same time, any changes, modifications and evolutions of any equivalent changes made to the above embodiments based on the substantial technology of the present application are still within the scope of the technical solution of the present application.

Claims

1. A vascular sheath capable of changing the direction of interventional operation, characterized in that: The vascular sheath comprises a hollow outer sheath, in which a first channel extending along the axial direction of the outer sheath is formed, and the head end and the tail end of the outer sheath are both open, and the first channel is connected with the openings of the head end and the tail end to form a passage along a first direction; A second channel is also constructed on the sheath wall of the outer sheath, and the second channel includes a straight section and a turning section, wherein the straight section extends along the axial direction of the outer sheath, and the turning section bends and extends along the wall thickness direction of the outer sheath to change direction, one end of the turning section is connected to the straight section, and the other end is bent and turned and then extends to be exposed outside the outer sheath, and the tail end opening of the outer sheath is connected to the second channel to form a passage along the second direction; Wherein, a guide wire runs through the passage along the second direction.

2. A vascular sheath capable of changing the direction of interventional operation as claimed in claim 1, characterized in that: The turning section is in an arc-shaped hole shape, and the central angle of the turning section is 180°.

3. A vascular sheath capable of changing the direction of interventional operation as claimed in claim 1, characterized in that: The straight line segment is a groove arranged on the inner wall of the outer sheath.

4. A vascular sheath capable of changing the direction of interventional operation as claimed in claim 1, characterized in that: The turning section is also connected to a guide tube, one end of which is inserted into and connected to the turning section, and the other end of which passes through the wall surface of the outer sheath and extends toward the tail end of the outer sheath; The guide wire passes through the tail end opening of the outer sheath and the second channel, turns, and then passes through the guide tube to pass through the outer sheath.

5. A vascular sheath capable of changing the direction of interventional operation as claimed in claim 4, characterized in that: The outer sheath is also connected with an injection tube, and the injection tube is communicated with the first channel.

6. A vascular sheath capable of changing the direction of interventional operation as claimed in claim 5, characterized in that: A marker point for indicating the position of the guide tube is arranged on the outer wall surface of the outer sheath.

7. A vascular sheath capable of changing the direction of interventional operation as claimed in claim 6, characterized in that: The marker point is aligned with the outlet end of the guide tube along the radial direction of the outer sheath.

8. The vascular sheath capable of changing the direction of interventional operation as claimed in claim 7, characterized in that: The marker points are arranged in a circle along the circumference of the outer sheath.

9. The vascular sheath capable of changing the direction of interventional operation as claimed in claim 1, characterized in that: The vascular sheath also includes an inner sheath, which can pass through the first channel, wherein the front end of the inner sheath is a pointed tip and the head end of the outer sheath is a flat head, so as to facilitate guiding the outer sheath into the blood vessel.

10. The vascular sheath capable of changing the direction of interventional operation according to claim 1, characterized in that: The distance between the turning section and the head end of the outer sheath is 5 cm.

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