Vascular closure device

Abstract

The utility model provides a blood vessel closing device which comprises a base body, a rotary knob and a pressure detection unit. The base body is provided with a first suture channel and a knob accommodating cavity, and the first suture channel penetrates through and communicates with the knob accommodating cavity; the knob is provided with a second suture channel, the knob is rotatably arranged in the knob containing cavity around the rotating axis, and a gap is formed between the knob and the cavity wall of the knob containing cavity; when the knob is located at the initial position, the second suture channel is communicated and aligned with the first suture channel, and the suture is allowed to movably penetrate through; the knob is configured to drive the suture in the second suture channel and the suture in the first suture channel to be staggered when rotating from the initial position to the locking position, so that the suture is pulled to enter the gap to form drawing of the suture; the base body presses a target tissue under the drawing action of the suture; and when the knob rotates from the initial position to the locking position, the pressure detection unit is directly or intermittently extruded by the suture, so that the pressure of the matrix on the target tissue is obtained.

Description

TECHNICAL FIELD

[0001] The utility model relates to medical instrument technical field, especially a kind of vascular closure device. BACKGROUND

[0002] Vascular intervention surgery is currently widely used in the treatment of cardiovascular and cerebrovascular diseases, structural heart disease, peripheral vascular disease and electrophysiological disease field, and it develops rapidly due to its minimally invasive, time-saving, safe and efficient advantages. With the development of medical devices, more and more types of vascular diseases tend to use minimally invasive surgical intervention. In order to reduce the pain of patients, part of surgical procedures such as valve replacement, pacemaker implantation and other surgical procedures are converted into interventional surgery. As a result, the complexity of interventional surgery gradually increases. In order to meet the use of complex instruments, the vascular opening gradually increases to a maximum of 30 Fr. The vascular opening of this size cannot be stopped bleeding by conventional bandaging and compression, and can only be effectively completed by compression after suturing.

[0003] Current vascular closure means such as suture and tourniquet can effectively complete the hemostatic task, but the patient needs to maintain a fixed position for a long time, usually 6-8 hours, and medical staff need to frequently release pressure to reduce ischemic risk. Some suture vascular closure devices or implantable vascular closure devices are currently used, which also have defects such as high cost, fixed size and high complication probability. SUMMARY

[0004] The utility model aims at providing a kind of vascular closure device, to solve the problems of low safety and comfort of existing vascular closure.

[0005] To solve the above technical problems, the utility model provides a kind of vascular closure device, it includes: base body, knob and pressure detection unit;

[0006] The base body has a first suture channel arranged in a first direction and a knob accommodating cavity arranged in a second direction, and the first suture channel communicates through the knob accommodating cavity;The knob has a second suture channel, the knob is rotatably arranged in the knob accommodating cavity, and there is a gap between the knob and the cavity wall of the knob accommodating cavity;

[0007] When the knob is in the initial position, the second suture channel is aligned with the first suture channel, allowing the suture to be actively threaded in the first suture channel and the second suture channel aligned through;

[0008] The knob is configured to drive the suture in the second suture channel to be misaligned with the suture in the first suture channel when the knob is rotated from the initial position to a locked position, so as to pull the suture into the gap to form a tension on the suture;

[0009] The base is configured to press the target tissue under the tension of the suture;

[0010] The pressure detection unit is configured to directly or indirectly receive the extrusion of the suture when the knob is rotated from the initial position to the locked position, so as to obtain the pressure of the base on the target tissue.

[0011] Optionally, the pressure detection unit comprises a mechanical pressure detection assembly, and the mechanical pressure detection assembly comprises a pressure measuring piece and a potential energy piece;

[0012] The pressure measuring piece is configured to move under the extrusion of the suture and balance with the potential capacity of the potential energy piece; the potential capacity corresponding to the movement amount of the pressure measuring piece is the pressure of the base on the target tissue.

[0013] Optionally, the mechanical pressure detection assembly further comprises a shaft body, and the pressure measuring piece is connected with the shaft body along the radial direction of the shaft body;

[0014] The knob has a shaft body accommodating cavity and a pressure measuring piece avoiding cavity, the shaft body is rotatably arranged in the shaft body accommodating cavity around a rotation axis, and the rotation axis extends along the second direction;

[0015] The pressure measuring piece avoiding cavity extends circumferentially around the rotation axis and is in communication with the second suture channel;

[0016] The pressure measuring piece is configured to rotate around the rotation axis in the pressure measuring piece avoiding cavity under the extrusion of the suture to drive the shaft body to rotate; the direction of the potential capacity applied by the potential energy piece to the pressure measuring piece is opposite to the rotation direction of the pressure measuring piece when the pressure measuring piece is extruded by the suture;

[0017] The potential capacity corresponding to the rotation amount of the shaft body and the pressure measuring piece is the pressure of the base on the target tissue.

[0018] Optionally, the knob has a potential energy piece accommodating cavity, and the mechanical pressure detection assembly further comprises a connecting piece;

[0019] The connecting piece is connected with the shaft body along the radial direction of the shaft body and is movably accommodated in the potential energy piece accommodating cavity; the potential energy piece is accommodated in the potential energy piece accommodating cavity, one end of the potential energy piece is connected with the connecting piece, and the other end of the potential energy piece is connected with the cavity wall of the potential energy piece accommodating cavity.

[0020] Optionally, the pressure measuring piece avoids the cavity and the pressure measuring piece is in the range of the second suture channel in the second direction; the potential energy piece accommodating cavity and the connecting piece are out of the range of the second suture channel in the second direction.

[0021] Optionally, the mechanical pressure detection assembly further comprises a pointer, the shaft body extends out of the knob at an end away from the second suture channel and is connected with the pointer, and the pointer is used to indicate the rotation angle of the shaft body.

[0022] Optionally, the pressure measuring piece is in an initial position when not being pressed by the suture, the pressure measuring piece drives the potential energy piece to store potential energy when being pressed by the suture, and the potential energy piece releases the stored potential energy to drive the connecting piece to return to the initial position when the pressure is released.

[0023] Optionally, the potential energy piece comprises an elastic potential energy piece or a magnetic potential energy piece; the elastic potential energy piece comprises a spring, a spring piece, a coil spring, silica gel or rubber; and the magnetic potential energy piece comprises a same-pole opposite magnet group.

[0024] Optionally, the pressure detection unit comprises an electronic pressure detection assembly, and the electronic pressure detection assembly is arranged at least one of the following positions:

[0025] a side of the base body for contacting the target tissue;

[0026] a side of the second suture channel for contacting the suture.

[0027] Optionally, the blood vessel closure device further comprises a suture, one end or a folded end of the suture is used for being sutured and fixed to the target tissue, and the other end or a free end of the suture is used for passing through the first suture channel and the second suture channel.

[0028] In summary, the blood vessel closure device provided by the utility model comprises a base body, a knob and a pressure detection unit.

[0029] The base body has a first suture channel arranged along a first direction and a knob accommodating cavity arranged along a second direction, the first suture channel is communicated through the knob accommodating cavity; the knob has a second suture channel, the knob is rotatably arranged in the knob accommodating cavity along a rotation axis extending along the second direction, and a gap is formed between the knob and the cavity wall of the knob accommodating cavity; when the knob is in an initial position, the second suture channel is aligned with the first suture channel in a through manner, so that a suture can be arranged in the first suture channel and the second suture channel in a through manner; when the knob is rotated from the initial position to a locked position, the suture in the second suture channel is dislocated with the suture in the first suture channel, so that the suture is pulled into the gap to form a tension on the suture; the base body is configured to press a target tissue under the tension of the suture; the pressure detection unit is configured to directly or indirectly receive the compression of the suture when the knob is rotated from the initial position to the locked position, so as to obtain the pressure of the base body on the target tissue.

[0030] In this way, after the suture is arranged in the first suture channel and the second suture channel, the tension on the suture can be formed by rotating the knob, and the base body is pressed to form the compression on the target tissue by the tension of the suture. Further, the pressure of the base body on the target tissue can be detected in real time by the pressure detection unit, and it can be determined whether the suture is pulled off or the compression is too large, so that the use convenience and safety of the blood vessel closure device are improved. BRIEF DESCRIPTION OF DRAWINGS

[0031] Those skilled in the art will understand that the drawings provided are for a better understanding of the present application, and do not constitute any limitation on the scope of the present application.

[0032] Figure 1 is a schematic view of a blood vessel closure device according to an embodiment of the present application.

[0033] Figure 2 is a schematic view of a suture and a target tissue according to an embodiment of the present application.

[0034] Figure 3 is a schematic view of a knob in an initial position according to an embodiment of the present application.

[0035] Figure 4 is a schematic view of a knob in a locked position according to an embodiment of the present application.

[0036] Figure 5 is a schematic view of a suture being pulled and extended according to an embodiment of the present application.

[0037] Figure 6It is the axial section view of the mechanical pressure detection assembly in the left view direction of the embodiment of the utility model.

[0038] Figure 7 It is Figure 6 It is the section view along A-A direction.

[0039] Figure 8 It is the right view of the mechanical pressure detection assembly of the embodiment of the utility model.

[0040] Figure 9 It is the rear view of the mechanical pressure detection assembly of the embodiment of the utility model.

[0041] Figure 10 It is the movement schematic view of the pressure measuring piece before and after being extruded by the suture.

[0042] Figure 11 It is the schematic view of the connecting piece moving with the shaft body of the embodiment of the utility model.

[0043] Figure 12 It is the schematic view of the pointer moving with the shaft body of the embodiment of the utility model.

[0044] Figure 13 It is the schematic view of the electronic pressure detection assembly of the embodiment of the utility model.

[0045] Figure 14 It is the relative relationship schematic view of the cutting channel and the first suture channel of the embodiment of the utility model.

[0046] Figure 15 It is the schematic view of the cutting assembly of the embodiment of the utility model.

[0047] Figure 16 And Figure 17 It is the schematic view of the protection piece of the embodiment of the utility model.

[0048] Figure 18 It is the schematic view of the blood vessel closure device of another embodiment of the utility model.

[0049] In the drawing: 1 - base body; 11 - first suture channel; 111 - first end; 112 - second end; 113 - first section; 114 - second section; 12 - knob accommodating cavity; 13 - cutting channel; 14 - pressing patch; 2 - knob; 21 - second suture channel; 22 - handle; 23 - shaft body accommodating cavity; 24 - pressure measuring piece avoiding cavity; 25 - potential piece accommodating cavity; 3 - pressure detection unit; 31 - pressure measuring piece; 32 - potential piece; 33 - shaft body; 34 - connecting piece; 35 - pointer; 36 - electronic pressure detection assembly; 4 - suture; 5 - target tissue; 51 - blood vessel; 6 - cutting assembly; 61 - cutter head; 62 - reset piece; 63 - button; 64 - protection piece; 7 - concave-convex structure. DETAILED DESCRIPTION

[0050] To make the objects, advantages and features of the present application more clearly, the following further describes the present application in conjunction with the drawings and specific embodiments. It should be noted that the drawings are all very simplified and not drawn in proportion, and are only used to facilitate and clearly assist the purpose of describing the embodiments of the present application. In addition, the structures shown in the drawings are often a part of the actual structures. In particular, the emphasis of each drawing needs to be different, and sometimes different proportions are used.

[0051] As used in the present application, the singular forms "a", "an", and "the" include plural referents, the term "or" is generally used in the sense of "and / or", the term "at least one" is generally used in the sense of "one or more", the term "at least two" is generally used in the sense of "two or more", and in addition, the terms "first", "second", "third" are only for the purpose of description, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first", "second", "third" can explicitly or implicitly include one or at least two features, "one end" and "the other end" and "proximal end" and "distal end" generally refer to two parts corresponding to each other, which not only includes the end point. In addition, as used in the present application, "mounting", "connecting", "connecting", "setting" one element in another element should be understood broadly, and generally only indicates that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the two elements can be directly or indirectly connected, coupled, cooperated or transmitted through intermediate elements, and cannot be understood as indicating or implying the spatial position relationship between the two elements, i.e. one element can be in any direction inside, outside, above, below or one side of another element, unless the content is otherwise explicitly indicated. For ordinary skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances. In addition, directional terms such as above, below, up, down, upward, downward, left, right, etc. are used with respect to the exemplary embodiments as they are shown in the drawings, upward or upward direction is toward the top of the corresponding drawing, and downward or downward direction is toward the bottom of the corresponding drawing.

[0052] The purpose of the present application is to provide a blood vessel closure device to solve the problem of low safety and comfort of existing blood vessel closure. The following description is made with reference to the drawings.

[0053] Please refer to Figures 1 to 4The utility model embodiment provides a kind of vascular closure device, it includes: matrix 1, knob 2 and pressure detection unit 3;The matrix 1 has the first suture channel 11 being arranged along first direction and knob containing cavity 12 being arranged along second direction, the first suture channel 11 is communicated through the knob containing cavity 12;The knob 2 has second suture channel 21, the knob 2 is rotatably arranged in the knob containing cavity 12, and the gap between the knob 2 and the cavity wall of the knob containing cavity 12;When the knob 2 is in initial position, the second suture channel 21 is aligned with the first suture channel 11, and suture 4 is arranged in the first suture channel 11 and the second suture channel 21 in through alignment;The knob 2 is configured to rotate from the initial position to locking position, suture 4 in the second suture channel 21 is driven to form misalignment with suture 4 in the first suture channel 11, so that suture 4 is pulled into the gap to form the pull of suture 4;The matrix 1 is configured to compress target tissue 5 under the pull effect of suture 4;The pressure detection unit 3 is configured, when the knob 2 rotates from the initial position to locking position, directly or indirectly receives the extrusion of suture 4, so that the pressure of the matrix 1 to the target tissue 5 is obtained.

[0054] Please refer to Figure 2 It shows one application scenario of the vascular closure device provided by the embodiment, and the backfolding end of suture 4 is used for suturing and fixing to target tissue 5. Target tissue 5 includes human tissue such as blood vessel 51, and the two ends of suture 4 are arranged out of target tissue 5 to form two free ends. In actual application, the two ends of suture 4 can be pulled, and target tissue 5 can be compressed at the same time. The vascular closure device provided by the embodiment can achieve the effect. Of course Figure 2 The application scenario shown is only an exemplary application scenario, and is not limited to the suturing method of suture 4. In other embodiments, suture 4 can also be single-end fixed, that is, one end of suture 4 is used for suturing and fixing to target tissue 5, for example, fixed by knotting or the like, and the other end of suture 4 is arranged out of target tissue 5. At this time, suture 4 arranged out of target tissue 5 can be pulled, and target tissue 5 can be compressed at the same time to achieve the effect of vascular closure. Therefore, it can be understood that suture 4 arranged in the first suture channel 11 and the second suture channel 21 can be single-strand or double-strand. In some complex application scenarios, suture 4 arranged in the first suture channel 11 and the second suture channel 21 can also be multi-strand, and the embodiment is not limited in this regard.

[0055] In an alternative example, the first direction and the second direction are perpendicular to each other, and the first direction is the z-axis, and the second direction is the x-axis. Optionally, the side of the base 1 facing the target tissue 5 has a pressing patch 14 for pressing against the surface (e.g. skin) of the target tissue 5 to achieve compression of the target tissue 5. Optionally, the knob 2 has a handle 22 for facilitating force application and operation.

[0056] The first suture channel 11 is formed along the z-axis direction, which can be a hole, a cavity, or a groove, etc. on the base 1, and the cross-sectional dimension of the first suture channel 11 is greater than the outer diameter of the suture 4 (or greater than the sum of the cross-sectional dimensions of the plurality of suture strands 4) to facilitate the suture 4 to pass through. The knob accommodating cavity 12 is formed on the base 1 along the x-axis direction, and the knob 2 can be disposed in the knob accommodating cavity 12 along the x-axis direction, and the knob 2 can rotate around the axis extending along the x-axis direction between an initial position (as shown in Figure 3 Figure 4

[0057] It should be noted that the first direction and the second direction are not necessarily straight lines, and in other embodiments, the first direction or the second direction can also be a direction with a certain curvature or bending. Therefore, the first suture channel 11 or the second suture channel 21 is not necessarily straight, and can also have a certain curvature or bending shape, which does not affect the threading and pulling of the suture 4. The first direction and the second direction are not necessarily perpendicular to each other, and as long as they form an angle, they can be achieved.

[0058] Please refer to Figure 3 When the knob 2 is in the initial position, the second suture channel 21 is aligned with the first suture channel 11, and at this time the suture 4 can be movably threaded in the first suture channel 11 and the second suture channel 21. It should be understood that the second suture channel 21 is aligned with the first suture channel 11, which is not a narrow definition that the second suture channel 21 must be strictly coaxial or identical to the first suture channel 11, and the cross-sectional shape or size of the second suture channel 21 and the first suture channel 11 can be different. The second suture channel 21 is aligned with the first suture channel 11, which means that the two ends of the second suture channel 21 along the z-axis direction have an overlapping area with the first suture channel 11, which is not less than the area that the suture 4 can pass through. Therefore, the suture 4 can be movably threaded.

[0059] Please refer to Figure 4 , the knob 2 rotates around the axis extending along the x-axis direction by a certain angle to reach the locked position. Please refer to Figure 2 ​​, the end of the suture 4 at the target tissue 5 (free end in some application scenarios) is fixed, and the end of the suture 4 away from the target tissue 5 (free end in some application scenarios) is preferably straightened after passing through the first suture channel 11 and the second suture channel 21 to reduce the slack, and then the knob 2 is rotated, the suture 4 in the second suture channel 21 and the suture 4 in the first suture channel 11 will be misaligned, and the suture 4 will be pulled into the gap between the knob 2 and the wall of the knob accommodating cavity 12. At this time, if a part of the suture 4 forms a fixed relationship with the base body 1, the base body 1 will be pressed against the target tissue 5 under the tension of the suture 4. It should be noted that the locked position is not limited to the limit position of the rotation stroke of the knob 2, but can be any angle position in the rotation stroke of the knob 2. The specific angle position can be set according to the stretching length of the suture 4, the tension or the compression force of the base body 1 on the target tissue 5.

[0060] In one embodiment, the gap between the knob 2 and the wall of the knob accommodating cavity 12 is not greater than the outer diameter of the suture 4, so that the suture 4 is deformed when pulled into the gap. At this time, the part of the suture 4 in the gap is equivalent to forming a fixed relationship with the base body 1, the original length of the suture 4 is stretched, the suture 4 is tightened, and the entire device is pressed down. At the same time, the knob 2 is also limited by the counterforce of the extrusion deformation of the suture 4, that is, the rotation of the knob 2 is limited at the locked position.

[0061] Please refer to Figure 5 During the rotation of the knob 2 from the initial position to the locked position, the total length L of the suture 4 changes from L1+L2+L3 to L1+L2+L3+L4+L5, and the length of the suture 4 is stretched, part of which is the extension of the suture 4 material itself, and the other part is the tightening of the suture 4 in the target tissue 5. While the suture 4 is tightened, the pressing patch 14 of the base body 1 contacts and abuts against the surface (such as the skin) of the target tissue 5, which provides a compression force to the blood vessel opening of the target tissue 5, thereby achieving compression hemostasis.

[0062] Alternatively, the gap does not necessarily have to be smaller than the outer diameter of the suture 4, and in some embodiments, the suture 4 can be fixed between the base body 1, for example, the end of the suture 4 away from the target tissue 5 can be fixed to the base body 1 by coiling or knotting after passing through the first suture channel 11, at this time, it is not limited to relying on the deformation of the suture 4 in the gap to achieve fixation. Of course, at this time, additional rotation limiting structure can be provided for the knob 2 to limit the rotation of the knob 2 at the locked position, so as to maintain the compression of the target tissue 5 for a period of time.

[0063] In an exemplary embodiment, the outer diameter of the knob 2 is configured to be within the stretchable range of the suture 4. For a large diameter blood vessel opening, the maximum diameter can be about 1 cm, and the pressing area of the base 1 on the target tissue 5 is usually a circular area with a diameter of not more than 5 cm. Hemostasis usually requires a pressure of 300 mmHg to 500 mmHg, and a pressing force of about 80 N needs to be provided. Taking a No. 0 suture 4 used for blood vessel suturing as an example, the tensile strength of the suture 4 is usually about 60 N, and the tensile strength of two sutures 4 is about 120 N. When each suture 4 is at a position corresponding to a pressing force of 40 N, the displacement of the suture 4 is about 1 cm, and the skin of the target tissue 5 can be pressed down by about 1 cm. When the corresponding displacement is reflected on the outer diameter of the knob 2, the outer diameter of the knob 2 can be configured to be within 1.5 cm, and the maximum rotation angle of the knob 2 from the initial position to the locked position is about 210 degrees, that is, the displacement of the suture 4 is within 3 cm.

[0064] The inventor further found that although the displacement of the suture 4 can be adjusted by configuring the outer diameter and the rotation angle of the knob 2, the suture 4 can be pulled off due to extrusion. In addition, there can be a loose amount at the connection between the suture 4 and the target tissue 5, so simply configuring the displacement of the suture 4 can not reliably achieve the pressing of the base 1 on the target tissue 5. For example, when the suture 4 is pulled off due to extrusion during the rotation of the knob 2 from the initial position to the locked position, the knob 2 can also be smoothly rotated to the locked position, but at this time the base 1 cannot generate a pressing force on the target tissue 5. For another example, in some target tissues 5 with weak deformation ability, a small displacement of the suture 4 can generate a sufficient pressing force of the base 1 on the target tissue 5. At this time, if the knob 2 is rotated too much, it can cause excessive pressing force and risks.

[0065] In order to solve the problem that the breaking of the suture 4, the insufficient pressing force, and the excessive pressing force cannot be effectively and reliably monitored, the blood vessel closure device provided in the embodiment is provided with a pressure detection unit 3, which detects the pressure of the base 1 on the target tissue 5 by directly or indirectly extruding the suture 4, can detect the pressure of the base 1 on the target tissue 5 in real time, can clearly know whether the suture 4 is pulled off or the pressing force is too large, and improves the use convenience and safety of the blood vessel closure device.

[0066] The pressure detection unit 3 can include various structural forms, for example, can include a mechanical pressure detection component, or can include an electronic pressure detection component such as a piezoelectric sensor. The different structural forms of the pressure detection unit 3 will be described below in conjunction with several embodiments.

[0067] Please refer to Figures 6 to 12In one embodiment, the pressure detecting unit 3 comprises a mechanical pressure detecting assembly; the mechanical pressure detecting assembly comprises a pressure measuring piece 31 and a potential energy piece 32; the pressure measuring piece 31 is configured to move under the extrusion of the suture 4 and balance with the potential capacity of the potential energy piece 32; the potential capacity corresponding to the movement amount of the pressure measuring piece 31 is the pressure of the base body 1 on the target tissue 5. The pressure measuring piece 31 is a component for contacting the suture 4, which can produce a certain movement under the extrusion of the suture 4, and the movement can be translation, rotation or torsion, etc., which can be set in combination with the potential energy piece 32. The pressure measuring piece 31 and the potential energy piece 32 are connected, and the potential energy piece 32 can exert a certain potential capacity on the pressure measuring piece 31, and the direction of the potential capacity is opposite or substantially opposite (i.e., at a certain angle) to the movement direction of the pressure measuring piece 31 under the extrusion of the suture 4. In this way, when the pressure measuring piece 31 moves to a certain position, the torque formed by the extrusion force of the suture 4 extruding the pressure measuring piece 31 and the torque formed by the potential capacity are balanced. By observing the displacement amount of the pressure measuring piece 31, the extrusion force of the suture 4 on the pressure measuring piece 31 can be calculated, and then the pressure of the base body 1 on the target tissue 5 can be obtained.

[0068] As mentioned before, the movement mode of the pressure measuring piece 31 is not limited in the present embodiment. Please refer to Figure 6 and Figure 7 In an alternative exemplary embodiment, the mechanical pressure detecting assembly further comprises a shaft body 33, the pressure measuring piece 31 is connected with the shaft body 33 along the radial direction of the shaft body 33; the knob 2 has a shaft body accommodating cavity 23 and a pressure measuring piece avoiding cavity 24, the shaft body 33 is rotatably arranged in the shaft body accommodating cavity 23 around a rotation axis, the rotation axis extends along the second direction; the pressure measuring piece avoiding cavity 24 extends circumferentially around the rotation axis and communicates with the second suture channel 21; the pressure measuring piece 31 is configured to rotate around the rotation axis in the pressure measuring piece avoiding cavity 24 under the extrusion of the suture 4 to drive the shaft body 33 to rotate; the direction of the potential capacity exerted by the potential energy piece 32 on the pressure measuring piece 31 is opposite to the rotation direction of the pressure measuring piece 31 under the extrusion of the suture 4; the potential capacity corresponding to the rotation amount of the shaft body 33 and the pressure measuring piece 31 is the pressure of the base body 1 on the target tissue 5.

[0069] Optionally, the shaft body accommodating cavity 23 is arranged at a position close to the center of the knob 2, and is preferably in a cylindrical shape. Thus, the rotation axis of the shaft body 33 can not coincide with the axis of the knob, but can be in a parallel relationship. The shaft body 33 is also a cylindrical shaft, and the inner diameter of the shaft body accommodating cavity 23 is adapted to the outer diameter of the shaft body 33, so as to limit the radial movement of the shaft body 33 in the shaft body accommodating cavity 23, and allow the rotation of the shaft body 33 in the shaft body accommodating cavity 23. The pressure measuring piece avoiding cavity 24 is a cavity in communication with the second suture channel 21, and extends around the rotation axis. In one embodiment, the cross-sectional shape of the pressure measuring piece avoiding cavity 24 is a sector, and the center of the circle is located on the rotation axis. The pressure measuring piece 31 can be a sheet-shaped piece, one end of which is fixedly connected to the shaft body 33, and the other end extends radially outward from the shaft body 33, and the extension length is preferably not beyond the outer peripheral contour of the knob 2. In this way, the pressure measuring piece 31 can reciprocate around the rotation axis within the sector of the pressure measuring piece avoiding cavity 24, together with the shaft body 33.

[0070] It can be understood that, since the movement mode of the pressure measuring piece 31 is configured to rotate around the rotation axis, the direction of the potential force applied by the potential energy piece 32 to the pressure measuring piece 31 is also preferably circumferential. In a simplified embodiment, a coil spring can be arranged on the outer periphery of the shaft body 33 as the potential energy piece 32, which can apply a circumferential elastic potential force to the shaft body 33, so as to offset and balance the circumferential displacement of the pressure measuring piece 31 caused by the extrusion force of the suture 4. Please refer to Figure 10 When the knob 2 is rotated clockwise, the suture 4 is equivalent to extruding the pressure measuring piece 31 counterclockwise, so that the pressure measuring piece 31 and the shaft body 33 generate counterclockwise rotation, and the potential energy piece 32 applies a clockwise potential force to the pressure measuring piece 31 and the shaft body 33, which can balance the extrusion force of the suture 4.

[0071] When the pressure measuring piece 31 is extruded by the suture 4 to generate movement, the potential energy piece 32 is synchronously pushed to generate deformation. Optionally, the potential energy piece 32 includes an elastic potential energy piece or a magnetic potential energy piece; the elastic potential energy piece includes a spring, a spring sheet, a coil spring, silica gel or rubber; and the magnetic potential energy piece includes a same-pole opposite magnet group. For the elastic potential energy piece, the deformation can be compression, winding or torsion, etc. For the magnetic potential energy piece, the deformation can be the relative approach of two magnets in the magnet group, etc. Optionally, the relationship between the deformation amount of the potential energy piece 32 and the potential force thereof can be calibrated in advance, so that in subsequent use, the corresponding potential force can be obtained by observing the displacement amount of the pressure measuring piece 31.

[0072] Please refer to Figure 8In a preferred embodiment, the knob 2 further has a potential energy element receiving cavity 25, and the mechanical pressure detection assembly further includes a connector 34; the connector 34 is connected to the shaft 33 radially and is movably received in the potential energy element receiving cavity 25; the potential energy element 32 is received in the potential energy element receiving cavity 25, one end of the potential energy element 32 is connected to the connector 34, and the other end of the potential energy element 32 is connected to the cavity wall of the potential energy element receiving cavity 25.

[0073] The connector 34 can be a sheet-like piece, with one end fixedly connected to the shaft 33 and the other end extending radially outward along the shaft 33, preferably not exceeding the outer periphery of the knob 2. The connector 34 can rotate with the shaft 33 about the rotation axis. The potential energy element receiving cavity 25 is a recess formed on the knob 2, in which both the connector 34 and the potential energy element 32 can be received. Taking a spring as an example of the potential energy element 32, one end abuts against the connector 34, and the other end abuts against the cavity wall of the potential energy element receiving cavity 25. When the connector 34 rotates with the shaft 33 about the rotation axis (e.g., when the spring is in motion), the potential energy element 32 rotates. Figure 11 The middle connector 34 moves upward until... Figure 11 (As shown by the dashed line), the spring will be compressed. During this process, the spring will exert an elastic potential force on the connector 34. When the torque generated by this elastic potential force balances the torque generated by the compressive force exerted by the seam 4 on the pressure measuring member 31, the assembly formed by the pressure measuring member 31, the shaft 33, and the connector 34 will stop rotating. It should be understood that the torque balance here does not necessarily mean that the elastic potential force and the compressive force exerted by the seam 4 on the pressure measuring member 31 are balanced; in practice, the lever arm lengths of both the elastic potential force and the compressive force must also be considered.

[0074] In one embodiment, the pressure measuring element 31 and the connecting element 34 can be arranged on opposite sides of the radial direction of the shaft 33, so that the combination of the pressure measuring element 31, the shaft 33 and the connecting element 34 is shaped like a seesaw centered on the axis of rotation.

[0075] Preferably, the pressure measuring element 31 is in its initial position when not compressed by the seam 4 (e.g., Figure 7 and Figure 10 (As shown); when the pressure measuring element 31 is compressed by the seam 4, it drives the potential energy element 32 to store potential energy; when the pressure measuring element 31 is released from pressure, the potential energy element 32 releases its stored potential energy, driving the connecting element 31 to return to its initial position. The pressure measuring element 31 should be able to return to its initial position when the pressure is released, so as to facilitate the reuse of the entire device. Figure 10 In the example shown, the pressure measuring element 31 is squeezed by the seam 4 and rotates about the rotation axis, reaching the point where... Figure 10 The position is indicated by the dashed line in the diagram.

[0076] In one embodiment, the arrangement of the connector 34 and the potential energy element receiving cavity 25 also provides an additional function of limiting the rotation of the pressure measuring element 31. The initial position of the pressure measuring element 31 when it is not compressed by the seam 4 ( Figure 7 The initial position is where the pressure testing component 31 is located. The second seam channel 21 should be kept clear to facilitate the insertion of the seam 4. Figure 7 For example, the potential energy applied by the potential energy element 32 to the pressure measuring element 31 is a circumferential force in the clockwise direction. If the rotational position of the pressure measuring element 31 is not restricted, it may... Figure 7 Based on its position, rotate clockwise until one end away from the rotation axis abuts against the upper sidewall of the second suture channel 21. This effectively blocks the second suture channel 21, hindering the insertion of the suture 4. Since the area of ​​the pressure measuring element 31 is mainly used for the suture 4 to abut against, setting an additional rotation limiter thereto can also easily hinder the insertion of the suture 4. By adjusting the cavity wall of the potential energy element receiving cavity 25 ( Figure 8 and Figure 11 The pressure measuring element 31 is positioned such that it rotates clockwise to the lower side wall of the cavity. Figure 7 When positioned, the connector 34 is exactly aligned with the cavity wall of the potential energy receiving cavity 25. Figure 8 and Figure 11 The pressure measuring element 31 is abutted against the lower cavity wall, which effectively restricts its rotation position, ensuring that even under the potential energy of the potential energy element 32, the pressure measuring element 31 can only rotate clockwise to a certain position. Figure 7 The initial position shown will not continue to rotate and block the second suture channel 21. Of course, it is understood that the limitation of the position of the connector 34 does not necessarily have to be achieved through the cavity wall of the potential energy member receiving cavity 25. In some alternative embodiments, a larger potential energy member receiving cavity 25 can be provided, and an additional rotation limiting abutment can be provided in it to abut against the connector 34 to achieve the same effect.

[0077] Please refer to the reference. Figure 6 and Figure 8 Preferably, the pressure measuring element clearance cavity 24 and the pressure measuring element 31 are located within the range of the second suture channel 12 in the second direction; the potential energy element receiving cavity 25 and the connecting element 34 are located outside the range of the second suture channel 12 in the second direction. Similarly, considering the need to ensure the unobstructed flow of the second suture channel 21, the potential energy element receiving cavity 25 and the connecting element 34 are arranged outside the range of the second suture channel 21 to avoid affecting the threading of the suture 4. Preferably, the potential energy element receiving cavity 25 and the connecting element 34 are located on the side of the knob 2 axially away from the second suture channel 21 to facilitate the opening of the second suture channel 21.

[0078] Please refer to Figure 6 , Figure 9 andFigure 12 Optionally, the mechanical pressure detecting assembly further comprises a pointer 35, the shaft body 33 extends out of the knob 2 along an end away from the second suture channel 21 and is connected with the pointer 35, the pointer 35 is used to indicate the rotation angle of the shaft body 33. Since the shaft body 33 is connected with the pressure measuring piece 31, the rotation angle of the shaft body 33 is the rotation angle of the pressure measuring piece 31. By knowing the deformation relationship of the potential energy piece 32 in advance, the potential energy at this time can be obtained, that is, the pressure of the suture 4 on the pressure measuring piece 31, so that the pressure of the base body 1 on the target tissue 5 can be obtained. The pointer 35 preferably extends along the radial direction of the shaft body 33 and is fixedly connected with the shaft body 33. The pointer 35 extends out of the knob 2, which is convenient for observation. In some embodiments, a scale mark can also be provided on the end face of the knob 2 or the handle 22, so as to facilitate the confirmation of the rotation angle of the pointer 35 relative to the knob 2. Figure 12 The rotation range of the pointer 35 is shown.

[0079] Please refer to Figure 3 , Figure 4 and Figure 13 In other embodiments, the pressure detecting unit comprises an electronic pressure detecting assembly 36, which is arranged at least one of:

[0080] the surface of the base body 1 for contacting the target tissue 5 (as shown in Figure 3 , Figure 4 and Figure 13 );

[0081] the surface of the second suture channel 21 for contacting the suture 4 (as shown in Figure 3 and Figure 4 ).

[0082] The electronic pressure detecting assembly 36, for example, comprises a piezoelectric sensor or the like, which can convert the pressure received into an electrical signal output, so as to directly obtain the information of the pressure.

[0083] Please refer to Figure 1 Preferably, the first suture channel 11 and the second suture channel 21 are both grooves having openings along the second direction. In application, in order to facilitate the threading of the suture 4, the first suture channel 11 and the second suture channel 21 can be configured as grooves opening towards the second direction, so that the suture 4 can enter the first suture channel 11 and the second suture channel 21 along the opening side of the second direction, which is convenient for operation.

[0084] Please refer to Figure 14 and Figure 15, preferably, the blood vessel closure device further comprises a cutting assembly 6; the base body 1 has a cutting channel 13 arranged along a third direction, the cutting channel 13 intersects the first suture channel 11; the cutting assembly 6 comprises a cutter head 61, the cutter head 61 is movably arranged in the cutting channel 13 for cutting the suture 4 threaded in the first suture channel 11.

[0085] The third direction is a direction which is angled with respect to both the first direction and the second direction, in one exemplary embodiment, the third direction is perpendicular to each of the first direction and the second direction, for example, the third direction is the y-axis, the cutter head 61 is movable along the y-axis. After the knob 2 is turned to the locking position and the compression on the target tissue 5 is maintained for a period of time, the blood vessel is substantially closed, at this time, the suture 4 can be cut by moving the cutter head 61 towards the first suture channel 11. After the suture 4 is cut, the entire blood vessel closure device can be removed. It should be understood that the third direction is not limited to be a straight direction, in other embodiments, the third direction can also be a direction with a certain curvature or bending. Thus, the cutting channel 13 is not limited to be linearly extended, it can also have a certain arc shape or bending shape, which does not affect the movement of the cutter head 61 and the cutting of the suture 4. The third direction is not limited to be perpendicular to the first direction or the second direction, as long as the third direction can form an angle with respect to the first direction or the second direction, the third direction can be achieved.

[0086] Optionally, the first suture channel 11 has a first end 111 and a second end 112 along the extension width range of the second direction; the cutter head 61 covers at least the first end 111 along the extension width range of the second direction, and at most does not exceed the second end 112. In order to improve the reliability of the cutting assembly 6 when performing cutting, the first suture channel 11 can be configured to have a certain extension width along the second direction (x-axis direction). Since the cutter head 61 covers at least the first end 111 along the extension width range of the second direction, it can be understood that the suture 4 can be reliably cut when it is as close as possible to the first end 111 along the x-axis direction. In an alternative exemplary embodiment, the cutter head 61 covers at least 0.5 mm beyond the first end 111 along the extension width range of the second direction, to ensure reliable coverage of the first suture channel 11 at the first end 111, and to ensure the reliability of cutting.

[0087] In another aspect, the extension width of the blade head 61 along the second direction is not more than the second end 112, so as to ensure that the blade head 61 does not extend out of the first suture channel 11 during cutting, thereby avoiding danger. In an embodiment, the extension width of the blade head 61 along the second direction can be a certain distance away from the second end 112, so as to reduce the risk of misuse of the cutting assembly 6. The suture 4 can not be cut at all positions along the x-axis direction in the first suture channel 11, but only in some areas. Preferably, the area of the first suture channel 11 that can be cut along the x-axis direction is not less than 5 mm, so as to ensure normal use. Optionally, the base body 1 has a cutting range mark corresponding to the extension width of the blade head 61 along the second direction.

[0088] Preferably, the first suture channel 11 is divided into a first section 113 and a second section 114 by the knob accommodating cavity 12, wherein the first section 113 is a section close to the target tissue 5 for abutting against the target tissue 5, and the cutting channel 13 intersects the first section 113. The cutting channel 13 intersects the first section 113, that is, the position of the suture 4 to be cut is located in the first section 113, i.e., the section close to the target tissue 5. In this way, the section of the suture 4 pressed and deformed by the knob 2 is located away from the cutting point of the target tissue 5, so as not to affect the subsequent suture removal of the suture 4, thereby avoiding the risk of the section of the suture 4 pressed and deformed causing obstruction in the tissue. At the same time, the cutting position of the suture 4 conforms to the clinical use habit.

[0089] Optionally, the cutting assembly 6 further comprises a reset member 62 for resetting the blade head 61. For example, the reset member 62 can exert a potential force on the blade head 61 to achieve the resetting. The blade head 61 is configured to be located outside the first suture channel 11 under the action of the potential force of the reset member 62 when not subjected to external force. The provision of the reset member 62 effectively improves the reliability of the cutting assembly 6 and reduces the risk of misoperation. The reset member 62 can include, for example, an elastic member (such as a spring) or a magnetic member (such as a group of same-pole opposite magnets), which can exert a repulsive force or a magnetic force on the blade head 61 in a direction away from the first suture channel 11, so that the blade head 61 is located away from the first suture channel 11 when not pressed.

[0090] In an alternative embodiment, the cutting assembly 6 further comprises a button 63, which can be fixedly connected with the blade head 61, and the reset member 62 comprises a spring, both ends of the spring being connected with the button 63 and the base body 1, respectively. During cutting, the operator presses the button 63 to drive the blade head 61 to move along the y-axis, at this time the spring is compressed to store potential energy. After the blade head 61 enters the first suture channel 11 to cut the suture 4, the operator releases the button 63, and the spring releases the potential energy to drive the blade head 61 to return to a position away from the first suture channel 11.

[0091] Further, please refer to Figure 16 and Figure 17 The cutting assembly 6 further comprises a protection member 64, which is switchable between a protection state and a release state; when the protection member 64 is in the protection state, the movement of the cutter head 61 in the cutting channel 13 is blocked; when the protection member 64 is in the release state, the cutter head 61 is released from the restriction, so that the cutter head 61 can move in the cutting channel 54 to cut the suture 4. In an exemplary embodiment, the protection member 64 is movably inserted into the base body 1 along the z-axis or the x-axis, and when the protection member 64 is moved along the z-axis or the x-axis to overlap with the y-directional position of the button 63, the protection member 64 is in the protection state. At this time, the movement of the button 63 along the y-axis is blocked by the protection member 64, and the button 63 cannot be pressed down, so that the cutter head 61 is equivalent to be limited, and cannot move along the cutting channel 54 to cut the suture 4. When the protection member 64 is moved along the z-axis or the x-axis to be disengaged from the y-directional position of the button 63, the protection member 64 is in the release state, and the protection member 64 releases the movement of the button 63, so that the cutter head 61 can freely move along the cutting channel 54 to cut the suture 4. When cutting is desired, the operator can pull out the protection member 64 from the base body 1, so as to switch the protection member 64 to the release state, and then perform the cutting.

[0092] Please refer to Figure 18 In another embodiment, the outer peripheral wall of the knob 2 and / or the cavity wall of the knob accommodating cavity 12 have a concave-convex structure 7. The concave-convex structure 7 is, for example, a wavy ridge. The concave-convex structure 7 is arranged to effectively tighten the suture 4 and improve the extrusion effect on the suture 4, and to increase the stretching distance of the suture 4 under the same outer diameter of the knob 2. Of course, in some other embodiments, the shape of the outer peripheral wall of the knob 2 and / or the cavity wall of the knob accommodating cavity 12 can be cylindrical, i.e. smooth wall, to simplify the design.

[0093] Optionally, the blood vessel closure device provided by the embodiment further comprises a suture 4, one end or a folded end of the suture 4 being used for being sutured and fixed to the target tissue 5, and the other end or a free end of the suture 4 being used for passing through the first suture channel 11 and the second suture channel 21.

[0094] In summary, the blood vessel closure device provided by the utility model comprises a base body, a knob and a pressure detection unit;

[0095] The base body has a first suture channel arranged along a first direction and a knob accommodating cavity arranged along a second direction, the first suture channel is communicated through the knob accommodating cavity; the knob has a second suture channel, the knob is rotatably arranged in the knob accommodating cavity along a rotation axis extending along the second direction, and a gap is formed between the knob and the cavity wall of the knob accommodating cavity; when the knob is in an initial position, the second suture channel is aligned with the first suture channel, allowing the suture to be movably arranged in the aligned first suture channel and second suture channel; when the knob is rotated from the initial position to a locked position, the suture in the second suture channel is misaligned with the suture in the first suture channel, so as to pull the suture into the gap to form a tension on the suture; the base body is configured to compress the target tissue under the tension of the suture; the pressure detection unit is configured to directly or indirectly receive the compression of the suture when the knob is rotated from the initial position to the locked position, so as to obtain the pressure of the base body on the target tissue. In this way, after the suture is arranged in the first suture channel and the second suture channel, the tension on the suture can be formed by rotating the knob, and the base body is pressed to form compression on the target tissue by the tension of the suture. Further, by arranging the pressure detection unit, the pressure of the base body on the target tissue can be detected in real time, whether the suture is pulled off or the compression force is too large can be determined, and the use convenience and safety of the blood vessel closure device are improved.

[0096] It should be noted that the above several embodiments can be combined with each other. The above description is only a description of the preferred embodiments of the present application, and does not limit the scope of the present application. Any modification or modification made by a person skilled in the art according to the above disclosure is within the protection scope of the present application.

Claims

1. A vascular closure device, characterized in that, include: Base, knob, and pressure sensing unit; The substrate has a first suture channel arranged in a first direction and a knob receiving cavity arranged in a second direction, the first suture channel passing through and communicating with the knob receiving cavity; the knob has a second suture channel, the knob is rotatably disposed in the knob receiving cavity, and there is a gap between the knob and the cavity wall of the knob receiving cavity; When the knob is in the initial position, the second suture channel is aligned with the first suture channel, allowing the suture to move through the aligned first and second suture channels. When the knob is configured to rotate from the initial position to the locked position, it causes the suture in the second suture channel to be misaligned with the suture in the first suture channel, thereby pulling the suture into the gap to form a pull on the suture. The matrix is ​​configured to compress the target tissue under the tension of the suture; The pressure detection unit is configured to directly or indirectly receive the compression of the suture when the knob is rotated from the initial position to the locked position, thereby obtaining the pressure of the matrix on the target tissue.

2. The vascular closure device according to claim 1, characterized in that, The pressure detection unit includes a mechanical pressure detection component, which includes a pressure measuring element and a potential energy element. The pressure measuring element is configured to move under the compression of the suture and to balance the potential energy of the potential energy element; the potential energy corresponding to the amount of movement of the pressure measuring element is the pressure of the matrix on the target tissue.

3. The vascular closure device according to claim 2, characterized in that, The mechanical pressure detection assembly also includes a shaft, and the pressure measuring element is connected to the shaft radially. The knob has a shaft housing cavity and a pressure measuring component clearance cavity. The shaft is rotatably disposed in the shaft housing cavity about a rotation axis, and the rotation axis extends along the second direction. The pressure measuring component clearance cavity extends circumferentially around the rotation axis and communicates with the second suture channel; The pressure measuring element is configured to rotate about the rotation axis in the pressure measuring element relief cavity under the compression of the seam, so as to drive the shaft to rotate; the direction of the potential force applied by the potential energy element to the pressure measuring element is opposite to the rotation direction of the pressure measuring element when it is compressed by the seam; The potential energy corresponding to the rotation of the shaft and the pressure measuring element is the pressure exerted by the matrix on the target tissue.

4. The vascular closure device according to claim 3, characterized in that, The knob has a potential energy receiving cavity, and the mechanical pressure detection assembly also includes a connector; The connector is connected to the shaft radially and is movably housed in the potential energy element receiving cavity; the potential energy element is housed in the potential energy element receiving cavity, one end of the potential energy element is connected to the connector, and the other end of the potential energy element is connected to the cavity wall of the potential energy element receiving cavity.

5. The vascular closure device according to claim 4, characterized in that, The pressure measuring component clearance cavity and the pressure measuring component are located within the range of the second suture channel in the second direction; the potential energy component receiving cavity and the connecting component are located outside the range of the second suture channel in the second direction.

6. The vascular closure device according to claim 3, characterized in that, The mechanical pressure detection assembly also includes a pointer, with the shaft extending from the knob at one end away from the second suture channel and connected to the pointer, the pointer being used to indicate the rotation angle of the shaft.

7. The vascular closure device according to claim 4, characterized in that, When the pressure measuring component is not compressed by the suture, it is in its initial position; when the pressure measuring component is compressed by the suture, it causes the potential energy component to store potential energy; when the pressure is released, the potential energy component releases its stored potential energy, driving the connector to return to its initial position.

8. The vascular closure device according to claim 2, characterized in that, The potential energy element includes an elastic potential energy element or a magnetic potential energy element; the elastic potential energy element includes a spring, a sheet, a coil spring, silicone, or rubber; the magnetic potential energy element includes a group of magnets with opposite poles.

9. The vascular closure device according to claim 1, characterized in that, The pressure detection unit includes an electronic pressure detection component, which is disposed at least in one of the following locations: The side of the substrate that is in contact with the target tissue; The second suture channel is the side that contacts the suture.

10. The vascular closure device according to claim 1, characterized in that, The vascular closure device also includes a suture, one end or a folded end of which is used to suture and fix to the target tissue, and the other end or a free end of which is used to pass through the first suture channel and the second suture channel.

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