Vascular Closure Devices

Abstract

The present invention provides a blood vessel closing device, which comprises: a base, a knob and a pressure detection unit; the base has a first suture channel arranged along a first direction and a knob accommodating cavity arranged along a second direction, the first suture channel penetrates and communicates with the knob accommodating cavity; the knob has a second suture channel, the knob is rotatably arranged in the knob accommodating cavity around a rotation axis extending along the second direction, and a gap is provided 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 passed through the aligned first suture channel and the second suture channel; when the knob is configured to rotate from the initial position to the locking position, the suture in the second suture channel is driven to be misaligned with the suture in the first suture channel, thereby pulling the suture into the gap to form a retraction of the suture; the base is configured to compress the target tissue under the retraction of the suture; the pressure detection unit is configured to be directly or indirectly squeezed by the suture when the knob is rotated from the initial position to the locking position, thereby obtaining the pressure of the base on the target tissue.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a blood vessel closing device. Background Art

[0002] Vascular interventional surgery is currently widely used in the treatment of cardiovascular and cerebrovascular diseases, structural heart disease, peripheral vascular disease and electrophysiological diseases. It has developed rapidly due to its advantages of being minimally invasive, time-saving, safe and efficient. With the development of medical devices, more and more types of vascular diseases tend to use minimally invasive surgical interventions. In order to reduce the pain of patients, some surgical procedures such as valve replacement and pacemaker implantation have been converted into interventional surgeries. As a result, the complexity of interventional surgery has gradually increased. In order to meet the use of complex instruments, the vascular opening has gradually become larger to a maximum of 30Fr. Vascular openings of this size cannot be stopped by conventional bandaging and compression, and compression after suturing is required to effectively complete postoperative vascular closure.

[0003] Current means of vascular closure, such as suture suturing and tourniquet, can effectively stop bleeding, but patients need to maintain a fixed position for a long time, usually 6-8 hours, and medical staff need to frequently relieve pressure to reduce the risk of ischemia. Currently, some suture-type vascular closure devices or implant-type vascular closure devices are also used, which also have defects such as high cost, fixed size, and high probability of complications. Summary of the invention

[0004] The object of the present invention is to provide a blood vessel closure device to solve the problems of low safety and comfort of existing blood vessel closure.

[0005] In order to solve the above technical problems, the present invention provides a blood vessel closing device, which includes: a base, a knob and a pressure detection unit; 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 penetrates and communicates with the knob accommodating cavity; the knob has a second suture channel, the knob is rotatably arranged in the knob accommodating cavity, and a gap is formed between the knob and the cavity wall of the knob accommodating cavity; When the knob is in the initial position, the second suture channel is aligned with the first suture channel, allowing the suture to be movably inserted into the aligned first suture channel and the second suture channel; 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 rotating from the initial position to the locking position, thereby pulling the suture into the gap to form a retraction of the suture; The base is configured to compress the target tissue under the pulling action 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 locking position, thereby obtaining the pressure of the matrix on the target tissue.

[0006] Optionally, the pressure detection unit includes a mechanical pressure detection component, and the mechanical pressure detection component includes a pressure measuring piece and a potential energy piece; The pressure measuring element is configured to move under the compression of the suture and to balance with the potential force of the potential energy element; the potential force corresponding to the movement of the pressure measuring element is the pressure of the matrix on the target tissue.

[0007] Optionally, the mechanical pressure detection assembly further includes a shaft body, and the pressure measuring member is connected to the shaft body along the radial direction of the shaft body; The knob has a shaft body accommodating cavity and a pressure measuring member 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; The pressure measuring piece avoidance cavity extends circumferentially around the rotation axis and is in communication with the second suture channel; The pressure measuring member is configured to rotate around the rotation axis in the pressure measuring member avoidance cavity under the pressure of the suture to drive the shaft body to rotate; the direction of the potential force applied by the potential energy member to the pressure measuring member is opposite to the rotation direction of the pressure measuring member when it is squeezed by the suture; The potential energy corresponding to the rotation amount of the shaft and the pressure measuring member is the pressure of the substrate on the target tissue.

[0008] Optionally, the knob has a potential energy member accommodating cavity, and the mechanical pressure detection assembly further includes a connecting member; The connecting member is connected to the shaft body along the radial direction of the shaft body and can be movably accommodated in the potential energy member accommodating cavity; the potential energy member is accommodated in the potential energy member accommodating cavity, one end of the potential energy member is connected to the connecting member, and the other end of the potential energy member is connected to the cavity wall of the potential energy member accommodating cavity.

[0009] Optionally, the pressure measuring member avoidance cavity and the pressure measuring member are located within the range of the second suture channel in the second direction; the potential energy member accommodating cavity and the connecting member are located outside the range of the second suture channel in the second direction.

[0010] Optionally, the mechanical pressure detection assembly further includes a pointer, the shaft extends out of the knob along an end away from the second suture channel and is connected to the pointer, and the pointer is used to indicate a rotation angle of the shaft.

[0011] Optionally, the pressure measuring member is in an initial position when not squeezed by the suture; when the pressure measuring member is squeezed by the suture, it drives the potential energy member to store potential energy; when the pressure measuring member is released from pressure, the potential energy member releases the stored potential energy and drives the connector to return to the initial position.

[0012] Optionally, the potential energy component includes an elastic potential energy component or a magnetic potential energy component; the elastic potential energy component includes a spring, a spring, a coil spring, silicone or rubber; and the magnetic potential energy component includes a group of magnets with the same poles facing each other.

[0013] Optionally, the pressure detection unit includes an electronic pressure detection component, and the electronic pressure detection component is disposed at at least one of the following locations: The substrate has a side that is in contact with the target tissue; The second suture channel is used for the side in contact with the suture.

[0014] Optionally, the blood vessel closing device further comprises a suture, one end or the folded end of the suture is used for suturing and fixing to the target tissue, and the other end or the free end of the suture is used for passing through the first suture channel and the second suture channel.

[0015] In summary, the blood vessel closing device provided by the present invention comprises: a base, a knob and a pressure detection unit; The base has a first suture channel arranged along a first direction and a knob accommodating cavity arranged along a second direction, the first suture channel penetrates and communicates with the knob accommodating cavity; the knob has a second suture channel, the knob is rotatably arranged in the knob accommodating cavity around a rotation axis extending along the second direction, and a gap is provided 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 passed through the aligned first suture channel and the second suture channel; when the knob is configured to rotate from the initial position to the locking position, the suture in the second suture channel is driven to be misaligned with the suture in the first suture channel, thereby pulling the suture into the gap to form a retraction of the suture; the base is configured to compress the target tissue under the retraction of the suture; the pressure detection unit is configured to be directly or indirectly squeezed by the suture when the knob is rotated from the initial position to the locking position, thereby obtaining the pressure of the base on the target tissue.

[0016] With such configuration, after the suture is inserted into the first suture channel and the second suture channel, the suture can be retracted by turning the knob, and the retraction of the suture causes the base to be pressed down to form pressure on the target tissue. Furthermore, by setting up the pressure detection unit, the pressure of the base on the target tissue can be detected in real time, and it can be clearly known whether the suture is broken or the pressure is too large, thereby improving the convenience and safety of the vascular closure device. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Those skilled in the art will appreciate that the drawings are provided for a better understanding of the present invention, but do not constitute any limitation on the scope of the present invention.

[0018] Figure 1 Schematic diagram of a blood vessel closing device according to an embodiment of the present invention.

[0019] Figure 2 Schematic diagram of a suture and a target tissue according to an embodiment of the present invention.

[0020] Figure 3 Schematic diagram of a knob in an initial position according to an embodiment of the present invention.

[0021] Figure 4 Schematic diagram of a knob in a locked position according to an embodiment of the present invention.

[0022] Figure 5 It is a schematic diagram of the suture being pulled and extended according to an embodiment of the present invention.

[0023] Figure 6 It is an axial cross-sectional view of the mechanical pressure detection component of an embodiment of the present invention as viewed from the left.

[0024] Figure 7 yes Figure 6 Cross-section along the AA direction.

[0025] Figure 8 It is a right view of the mechanical pressure detection component according to an embodiment of the present invention.

[0026] Fig. 9 It is a rear view of the mechanical pressure detection component according to an embodiment of the present invention.

[0027] Fig.10 Schematic diagram of the movement of the pressure measuring piece before and after being squeezed by the suture in the embodiment of the present invention.

[0028] Fig.11 It is a schematic diagram of the connecting member according to an embodiment of the present invention moving along with the shaft.

[0029] Fig.12 It is a schematic diagram of the pointer moving along with the shaft according to an embodiment of the present invention.

[0030] Fig.13 Schematic diagram of an electronic pressure detection component according to an embodiment of the present invention.

[0031] Fig.14 It is a schematic diagram of the relative relationship between the cutting channel and the first suture channel of an embodiment of the present invention.

[0032] Fig.15 Schematic diagram of a cutting assembly according to an embodiment of the present invention.

[0033] Fig.16 and Fig.17 Schematic diagram of a protective member according to an embodiment of the present invention.

[0034] Fig.18 FIG. 4 is a schematic diagram of a blood vessel closing device according to another embodiment of the present invention.

[0035] In the accompanying drawings: 1-base; 11-first suture channel; 111-first end; 112-second end; 113-first section; 114-second section; 12-knob accommodating chamber; 13-cutting channel; 14-pressing patch; 2-knob; 21-second suture channel; 22-handle; 23-shaft accommodating chamber; 24-pressure measuring piece avoidance chamber; 25-potential energy piece accommodating chamber; 3-pressure detection unit; 31-pressure measuring piece; 32-potential energy piece; 33-shaft; 34-connecting piece; 35-pointer; 36-electronic pressure detection assembly; 4-suture; 5-target tissue; 51-blood vessel; 6-cutting assembly; 61-knife head; 62-resetting piece; 63-button; 64-protective piece; 7-concave and convex structure. DETAILED DESCRIPTION

[0036] In order to make the purpose, advantages and features of the present invention clearer, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. In addition, the structure shown in the drawings is often a part of the actual structure. In particular, the emphasis of each drawing is different, and sometimes different scales are used.

[0037] As used in the present invention, the singular forms "a", "an", "one" and "the" include plural objects, the term "or" is usually used to include the meaning of "and / or", the term "several" is usually used to include the meaning of "at least one", and the term "at least two" is usually used to include the meaning of "two or more". In addition, the terms "first", "second" and "third" are used only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of indicated technical features. Therefore, the features defined as "first", "second" and "third" may explicitly or implicitly include one or at least two of the features, "one end" and "the other end" as well as "proximal end" and "distal end" generally refer to two corresponding parts, which include not only endpoints. In addition, as used in the present invention, "installed", "connected", "connected", and one element "set" on another element should be understood in a broad sense, usually only indicating that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the connection, coupling, cooperation or transmission between the two elements can be direct or indirect through an intermediate element, and cannot be understood as indicating or implying the spatial position relationship between the two elements, that is, one element can be in any orientation such as inside, outside, above, below or one side of another element, unless the content clearly indicates otherwise. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances. In addition, directional terms such as above, below, up, down, upward, downward, left, right, etc. are used relative to the exemplary embodiments as shown in the figures, with the upward or upper direction toward the top of the corresponding figure, and the downward or lower direction toward the bottom of the corresponding figure.

[0038] The object of the present invention is to provide a blood vessel closure device to solve the problem of low safety and comfort of existing blood vessel closure.

[0039] Please refer to Figures 1 to 4The embodiment of the present invention provides a blood vessel closing device, which includes: a base 1, a knob 2 and a pressure detection unit 3; the base 1 has a first suture channel 11 arranged along a first direction and a knob accommodating cavity 12 arranged along a second direction, the first suture channel 11 penetrates and communicates with the knob accommodating cavity 12; the knob 2 has a second suture channel 21, the knob 2 is rotatably arranged in the knob accommodating cavity 12, and there is a gap between the knob 2 and the cavity wall of the knob accommodating cavity 12; when the knob 2 is in an initial position, the second suture channel 21 is aligned with the first suture channel 11, allowing the suture 4 to pass through the aligned suture channel. The first suture channel 11 and the second suture channel 21 are movably arranged; the knob 2 is configured to drive the suture 4 in the second suture channel 21 to be misaligned with the suture 4 in the first suture channel 11 when it is rotated from the initial position to the locking position, thereby pulling the suture 4 into the gap to form a retraction of the suture 4; the base 1 is configured to compress the target tissue 5 under the retraction action of the suture 4; the pressure detection unit 3 is configured to be directly or indirectly squeezed by the suture 4 when the knob 2 is rotated from the initial position to the locking position, thereby obtaining the pressure of the base 1 on the target tissue 5.

[0040] Please refer to Figure 2 , which shows an application scenario of the blood vessel closure device provided by this embodiment, the folded end of the suture 4 is used to suture and fix to the target tissue 5. The target tissue 5 includes human tissue such as blood vessels 51, and the two ends of the suture 4 pass through the target tissue 5 respectively to form two free ends. In practical applications, the two ends of the suture 4 can be pulled and the target tissue 5 can be compressed at the same time. The blood vessel closure device provided by this embodiment can achieve this effect. Of course Figure 2 What is shown is only an exemplary application scenario and not a limitation on the suturing method of the suture 4. In some other embodiments, the suture 4 may also be fixed at one end, that is, one end of the suture 4 is used to sew and fix to the target tissue 5, for example, by tying a knot or the like, and the other end of the suture 4 passes through the target tissue 5. At this time, the suture 4 passing through the target tissue 5 is retracted, and the effect of blood vessel closure can also be achieved by combining the compression of the target tissue 5. It can be understood that the suture 4 inserted into the first suture channel 11 and the second suture channel 21 can be single-strand or double-strand. In some complex application scenarios, the suture 4 inserted into the first suture channel 11 and the second suture channel 21 can also be multi-strand, which is not limited in this embodiment.

[0041] In an alternative exemplary embodiment, 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 base 1 has a pressing patch 14 on the side facing the target tissue 5, and the pressing patch 14 is used to abut against the surface (such as skin) of the target tissue 5 to achieve compression of the target tissue 5. Optionally, the knob 2 has a handle 22 to facilitate force application and operation.

[0042] The first suture channel 11 is opened along the z-axis direction, and can be a hole, cavity or groove that penetrates the base 1, and its cross-sectional size is larger than the outer diameter of the suture 4 (or larger than the sum of the cross-sectional sizes of several strands of suture 4) to facilitate the insertion of the suture 4. The knob accommodating cavity 12 is opened along the x-axis direction on the base 1, and the knob 2 can be arranged in the knob accommodating cavity 12 along the x-axis direction, and the knob 2 can be rotated around the axis extending along the x-axis direction in the initial position (such as Figure 3 as shown) and locked position (as Figure 4 as shown).

[0043] It should be noted that the first direction and the second direction are not limited to being straight lines. In other embodiments, the first direction or the second direction may also be a direction with a certain curvature or bend. Thus, the first suture channel 11 or the second suture channel 21 is not limited to extending in a straight line. It may also be in a certain arc or bend shape, which will not affect the threading and pulling of the suture 4. The first direction and the second direction are not limited to being perpendicular to each other. As long as they can form an angle, they can be achieved.

[0044] 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 the suture 4 can be movably inserted in the aligned first suture channel 11 and the second suture channel 21. It should be understood that the alignment of the second suture channel 21 with the first suture channel 11 here does not narrowly limit the second suture channel 21 and the first suture channel 11 to be strictly coaxial or identical, and the cross-sectional shape or size of the second suture channel 21 and the first suture channel 11 may be different. The alignment of the second suture channel 21 with the first suture channel 11 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 that is not less than the area through which the suture 4 can pass. In this way, the suture 4 can be movably inserted.

[0045] Please refer to Figure 4 , the knob 2 reaches the locked position after rotating a certain angle around the axis extending along the x-axis direction. Figure 2, one end of the suture 4 at the target tissue 5 (the folded end in some application scenarios) is equivalent to being fixed, and the end of the suture 4 away from the target tissue 5 (the 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 looseness, and then the knob 2 is turned, 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 cavity wall of the knob accommodating cavity 12. At this time, if a part of the suture 4 forms a fixed relationship with the base 1, the base 1 will compress the target tissue 5 under the pulling action of the suture 4. It should be noted that the locking position is not limited to the limit position of the rotation stroke of the knob 2, but can be any angular position in the rotation stroke of the knob 2. Its specific angular position can be set according to the stretching length of the suture 4, the pulling pressure, or the compressive force of the base 1 on the target tissue 5.

[0046] In one embodiment, the gap between the knob 2 and the cavity wall of the knob accommodating cavity 12 is not larger than the outer diameter of the suture 4, so that the suture 4 is deformed when being pulled into the gap. At this time, the portion of the suture 4 in the gap is equivalent to forming a fixed relationship with the base 1, the original length of the suture 4 is stretched, and the suture 4 is tightened, causing the entire device to be pressed down. At the same time, the knob 2 is also limited by the reaction force of the extrusion deformation of the suture 4, that is, the rotation of the knob 2 is limited to the locked position.

[0047] Please refer to Figure 5 In the process of rotating the knob 2 from the initial position to the locking 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 1 contacts and abuts against the surface of the target tissue 5 (such as skin), which provides a compressive force on the blood vessel opening of the target tissue 5, thereby achieving compression hemostasis.

[0048] Optionally, the gap does not have to be smaller than the outer diameter of the suture 4. In some embodiments, the suture 4 can also be fixed to the base 1. For example, after passing through the first suture channel 11, the end of the suture 4 away from the target tissue 5 can be fixed to the base 1 by coiling or knotting. In this case, the fixation is not limited to relying on the deformation of the suture 4 in the gap. Of course, an additional rotation-limiting structure can be set for the knob 2 to limit the rotation of the knob 2 to the locked position, so as to maintain the pressure on the target tissue 5 for a period of time.

[0049] In an exemplary embodiment, the outer diameter of the knob 2 must be within the tensile range that the suture 4 can withstand. For large-caliber blood vessel openings, the maximum can reach about 1 cm. The compression area of ​​the base 1 on the target tissue 5 is usually a circular area with a diameter of no more than 5 cm. Hemostasis usually requires a pressure of 300 mmHg to 500 mmHg, and a compressive force of about 80 N is required. Taking the suture 4 used for vascular suture as No. 0 line as an example, its tensile strength is usually about 60 N, and the two strands of suture 4 together are about 120 N. When each strand of suture 4 is at the position corresponding to the compressive force of 40 N, the displacement of the suture 4 is about 1 cm. When the skin of the target tissue 5 may be pressed by 1 cm, the corresponding displacement is reflected on the outer diameter of the knob 2. The outer diameter of the knob 2 can be configured 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.

[0050] The inventors further discovered that, although the displacement of the suture 4 can be adjusted by configuring the outer diameter and rotation angle of the knob 2, the suture 4 may be broken due to compression. In addition, there may be looseness at the connection between the suture 4 and the target tissue 5, so simply configuring the displacement of the suture 4 may not reliably achieve the compression of the target tissue 5 by the base 1. For example, when the suture 4 is squeezed and broken during the process of the knob 2 rotating from the initial position to the locking position, although the knob 2 can also be smoothly rotated to the locking position, the base 1 cannot generate a compressive force on the target tissue 5 at this time. For another example, at some target tissues 5 with weaker deformation ability, a small displacement of the suture 4 may be enough for the base 1 to generate sufficient compressive force on the target tissue 5. At this time, if the knob 2 is rotated excessively, it may cause excessive compressive force and create risks.

[0051] In order to solve the problem that it is impossible to effectively and reliably monitor whether the suture 4 is broken, whether the pressure is insufficient or too great, the vascular closure device provided in this 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 receiving the compression of the suture 4. The pressure of the base 1 on the target tissue 5 can be detected in real time, and it can be clearly known whether the suture 4 is broken or whether the pressure is too great, thereby improving the convenience and safety of the vascular closure device.

[0052] The pressure detection unit 3 may include various structural forms, for example, a mechanical pressure detection component, or an electronic pressure detection component, such as a piezoelectric sensor, etc. The different structural forms of the pressure detection unit 3 are described below in conjunction with several embodiments.

[0053] Please refer to Figures 6 to 12In one embodiment, the pressure detection unit 3 includes a mechanical pressure detection assembly; the mechanical pressure detection assembly includes a pressure measuring piece 31 and a potential energy piece 32; the pressure measuring piece 31 is configured to move under the compression of the suture 4 and balance the potential energy of the potential energy piece 32; the potential energy corresponding to the movement of the pressure measuring piece 31 is the pressure of the substrate 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 compression of the suture 4, and the movement can be translation, rotation or torsion, etc., which can be specifically 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 apply a certain potential energy to the pressure measuring piece 31, and the direction of the potential energy is opposite or approximately opposite to the direction of movement of the pressure measuring piece 31 under the compression of the suture 4 (meaning at a certain angle), so that when the pressure measuring piece 31 moves to a certain position, the torque formed by the compression force of the suture 4 compressing the pressure measuring piece 31 is balanced with the torque formed by the potential energy. By observing the displacement of the pressure measuring piece 31 , the magnitude of the squeezing force of the suture 4 on the pressure measuring piece 31 can be calculated, and then the pressure of the matrix 1 on the target tissue 5 can be obtained.

[0054] As mentioned above, this embodiment does not limit the movement of the pressure measuring member 31. Figure 6 and Figure 7 In an alternative exemplary embodiment, the mechanical pressure detection component further includes a shaft body 33, and the pressure measuring member 31 is connected to the shaft body 33 along the radial direction of the shaft body 33; the knob 2 has a shaft body accommodating chamber 23 and a pressure measuring member avoidance chamber 24, and the shaft body 33 is rotatably arranged in the shaft body accommodating chamber 23 around a rotation axis, and the rotation axis extends along the second direction; the pressure measuring member avoidance chamber 24 extends circumferentially around the rotation axis and is connected to the second suture channel 21; the pressure measuring member 31 is configured to rotate around the rotation axis in the pressure measuring member avoidance chamber 24 under the compression of the suture 4 to drive the shaft body 33 to rotate; the direction of the potential force applied by the potential energy member 32 to the pressure measuring member 31 is opposite to the rotation direction of the pressure measuring member 31 when being compressed by the suture 4; the potential force corresponding to the rotation amount of the shaft body 33 and the pressure measuring member 31 is the pressure of the substrate 1 on the target tissue 5.

[0055] Optionally, the shaft body accommodating cavity 23 is opened near the center of the knob 2, and its shape is preferably cylindrical. As a result, the rotation axis of the shaft body 33 and the axis of the knob may not coincide, but may be parallel. 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, thereby limiting the radial movement of the shaft body 33 in the shaft body accommodating cavity 23, while allowing the shaft body 33 to rotate in the shaft body accommodating cavity 23. The pressure measuring piece avoidance cavity 24 is a cavity connected to the second suture channel 21, which extends around the rotation axis. In one embodiment, the cross-sectional shape of the pressure measuring piece avoidance cavity 24 is fan-shaped, and its center is located on the rotation axis. The pressure measuring piece 31 can be a sheet-like piece, one end of which is fixedly connected to the shaft body 33, and the other end extends radially outward along the shaft body 33, and its extension length preferably does not exceed the outer peripheral contour range of the knob 2. With such configuration, the pressure measuring member 31 together with the shaft body 33 can reciprocate around the rotation axis within the sector-shaped range of the pressure measuring member avoidance cavity 24 .

[0056] It is understandable that, since the movement mode of the pressure measuring member 31 is configured to rotate around the rotation axis, the direction of the potential force exerted by the potential energy member 32 on the pressure measuring member 31 is also preferably circumferential. In a simplified embodiment, a coil spring can be arranged on the periphery of the shaft 33 as the potential energy member 32, which can exert circumferential elastic potential force on the shaft 33, thereby offsetting and balancing the circumferential displacement of the pressure measuring member 31 caused by the extrusion force of the suture 4. Please refer to Fig.10 When the knob 2 is rotated clockwise, the suture 4 is equivalent to squeezing the pressure measuring piece 31 counterclockwise, causing the pressure measuring piece 31 and the shaft 33 to rotate counterclockwise, and the potential energy piece 32 applies a clockwise potential energy to the pressure measuring piece 31 and the shaft 33, which can balance the squeezing force of the suture 4.

[0057] When the pressure measuring member 31 is squeezed by the suture 4 and moves, it simultaneously pushes the potential energy member 32 to deform. Optionally, the potential energy member 32 includes an elastic potential energy member or a magnetic potential energy member; the elastic potential energy member includes a spring, a spring, a coil spring, silicone or rubber; the magnetic potential energy member includes a group of magnets with the same poles facing each other. For the elastic potential energy member, its deformation can be, for example, compression, winding or torsion. For the magnetic potential energy member, its deformation can be, for example, the relative proximity of two magnets in the magnet group. Optionally, the relationship between the deformation of the potential energy member 32 and its potential energy can be calibrated in advance, so that the corresponding potential energy can be obtained by observing the displacement of the pressure measuring member 31 in subsequent use.

[0058] Please refer to Figure 8In a preferred embodiment, the knob 2 also has a potential energy member accommodating chamber 25, and the mechanical pressure detection assembly also includes a connecting member 34; the connecting member 34 is connected to the shaft body 33 along the radial direction of the shaft body 33, and can be movably accommodated in the potential energy member accommodating chamber 25; the potential energy member 32 is accommodated in the potential energy member accommodating chamber 25, one end of the potential energy member 32 is connected to the connecting member 34, and the other end of the potential energy member 32 is connected to the cavity wall of the potential energy member accommodating chamber 25.

[0059] The connecting member 34 can be a sheet-like member, one end of which is fixedly connected to the shaft body 33, and the other end of which extends radially outwardly along the shaft body 33, and the extension length preferably does not exceed the outer peripheral contour range of the knob 2. The connecting member 34 can rotate around the rotation axis along with the shaft body 33. The potential energy member accommodating chamber 25 is a concave cavity opened on the knob 2, and both the connecting member 34 and the potential energy member 32 can be accommodated in the potential energy member accommodating chamber 25. Taking a spring as an example of the potential energy member 32, one end of the spring abuts against the connecting member 34, and the other end abuts against the cavity wall of the potential energy member accommodating chamber 25. When the connecting member 34 rotates around the rotation axis along with the shaft body 33 (such as Fig.11 The middle connecting member 34 moves upward to Fig.11 The spring is compressed when the spring is pulled out of the position shown by the dotted line in the middle. In this process, the spring will exert an elastic potential force on the connecting member 34. When the torque formed by the elastic potential force is balanced with the torque formed by the extrusion force exerted by the suture 4 on the pressure measuring member 31, the combination formed by the pressure measuring member 31, the shaft 33 and the connecting member 34 will stop rotating. It should be understood that the moment balance here does not limit the balance between the elastic potential force and the extrusion force exerted by the suture 4 on the pressure measuring member 31. In practice, the length of the force arm of the elastic potential force and the extrusion force should also be considered.

[0060] In one embodiment, the pressure measuring member 31 and the connecting member 34 may be arranged on opposite sides of the shaft 33 in the radial direction, so that the combination formed by the pressure measuring member 31, the shaft 33 and the connecting member 34 is shaped like a seesaw with the rotation axis as the center.

[0061] Preferably, the pressure measuring member 31 is in an initial position (eg, Figure 7 and Fig.10 As shown); when the pressure measuring member 31 is squeezed by the suture 4, it drives the potential energy member 32 to store potential energy; when the pressure measuring member 31 is released from pressure, the potential energy member 32 releases its stored potential energy and drives the connecting member 31 to return to the initial position. When the pressure measuring member 31 is released from pressure, it should be able to return to the initial position to facilitate the reuse of the entire device. Fig.10 In the exemplary embodiment shown, the pressure measuring member 31 is pressed by the suture 4 and rotates around the rotation axis to reach the position shown in FIG. Fig.10 The position is shown by the dotted line.

[0062] In one embodiment, the arrangement of the connecting member 34 and the potential energy member accommodating chamber 25 also has an additional rotation limiting effect on the pressure measuring member 31. When the pressure measuring member 31 is not squeezed by the suture 4, the initial position ( Figure 7 The position of the middle pressure measuring piece 31 is the initial position), and the second suture channel 21 should be kept unobstructed to facilitate the insertion of the suture 4. Figure 7 For example, the potential force exerted by the potential energy member 32 on the pressure measuring member 31 is a clockwise circumferential force. If the rotation position of the pressure measuring member 31 is not restricted, it may Figure 7 The pressure measuring member 31 is rotated clockwise based on the position until the end away from the rotation axis abuts against the upper side wall of the second suture channel 21, which is equivalent to blocking the second suture channel 21, and the suture 4 is blocked from passing through. Since the area of ​​the pressure measuring member 31 is mainly used for the suture 4 to abut, setting an additional rotation limiter on it can also easily hinder the suture 4 from passing through. By adjusting the cavity wall ( Figure 8 and Fig.11 The position of the lower cavity wall in the cavity is configured so that the pressure measuring member 31 rotates clockwise to Figure 7 When the position is set, the connecting member 34 is just in contact with the cavity wall of the potential energy member accommodating cavity 25 ( Figure 8 and Fig.11 The lower cavity wall of the pressure measuring member 31 is abutted against the pressure measuring member 31, which is equivalent to limiting the rotation position of the pressure measuring member 31, so that the pressure measuring member 31 can only rotate clockwise to the position as shown in FIG. Figure 7 The connector 34 is in the initial position shown in the figure, and will not continue to rotate to block the second suture channel 21. Of course, it can be understood that the position of the connector 34 is not necessarily limited by the cavity wall of the potential energy component accommodating cavity 25. In some alternative embodiments, a larger potential energy component accommodating cavity 25 can also be provided, and an additional rotation-limiting abutment member is provided therein to abut against the connector 34, thereby achieving the same effect.

[0063] Please refer to Figure 6 and Figure 8 Preferably, the pressure measuring member avoidance cavity 24 and the pressure measuring member 31 are located within the second suture channel 12 in the second direction; the potential energy member accommodating cavity 25 and the connecting member 34 are located outside the second suture channel 12 in the second direction. Also, in order to ensure the patency of the second suture channel 21, the potential energy member accommodating cavity 25 and the connecting member 34 are arranged outside the second suture channel 21 to avoid affecting the threading of the suture 4. Preferably, the potential energy member accommodating cavity 25 and the connecting member 34 are located on the side of the knob 2 axially away from the second suture channel 21, so as to facilitate the opening of the second suture channel 21.

[0064] Please refer to Figure 6 , Fig. 9 and Fig.12 Optionally, the mechanical pressure detection assembly also includes a pointer 35, the shaft body 33 extends out of the knob 2 along one end away from the second suture channel 21 and is connected to the pointer 35, and the pointer 35 is used to indicate the rotation angle of the shaft body 33. Since the shaft body 33 is connected to the pressure measuring member 31, the rotation angle of the shaft body 33 is the rotation angle of the pressure measuring member 31. Through the deformation relationship of the potential energy member 32 calibrated in advance, the potential energy at this time, that is, the pressure of the suture 4 on the pressure measuring member 31, can be known, so that the pressure of the matrix 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 to the shaft body 33. The pointer 35 extends out of the knob 2 for easy observation. In some embodiments, a scale mark can also be set on the end face of the knob 2 or the handle 22 to facilitate confirmation of the rotation angle of the pointer 35 relative to the knob 2. Fig.12 The rotation range of the pointer 35 is shown schematically.

[0065] Please refer to Figure 3 , Figure 4 and Fig.13 In some other embodiments, the pressure detection unit includes an electronic pressure detection component 36, and the electronic pressure detection component 36 is disposed at at least one of the following locations: The substrate 1 has a side (such as Figure 3 , Figure 4 and Fig.13 shown); The second suture channel 21 is used for contacting the suture 4 on one side (such as Figure 3 and Figure 4 as shown).

[0066] The electronic pressure detection component 36 includes, for example, a piezoelectric sensor, etc., which can convert the pressure received into an electrical signal output, thereby directly obtaining pressure information.

[0067] Please refer to Figure 1 Preferably, the first suture channel 11 and the second suture channel 21 are both grooves with openings along the second direction. In application, in order to facilitate the insertion of the suture 4, the first suture channel 11 and the second suture channel 21 can be configured as grooves opening toward the second direction, so that the suture 4 can enter the first suture channel 11 and the second suture channel 21 laterally along the opening in the second direction, which is convenient for operation.

[0068] Please refer to Fig.14 and Fig.15Preferably, the vascular closure device further comprises a cutting assembly 6; the base body 1 has a cutting channel 13 arranged along a third direction, and the cutting channel 13 intersects with the first suture channel 11; the cutting assembly 6 comprises a cutting head 61, and the cutting head 61 is movably arranged in the cutting channel 13, and is used for cutting the suture 4 passing through the first suture channel 11.

[0069] The third direction is a direction that is at an angle to both the first direction and the second direction. In an exemplary embodiment, the third direction is perpendicular to both the first direction and the second direction. Taking the third direction as the y-axis as an example, the cutter head 61 can move along the y-axis. After the knob 2 is rotated to the locked position and the pressure on the target tissue 5 is maintained for a period of time, the blood vessel is basically closed. At this time, the suture 4 can be cut by moving the cutter head 61 in the direction of the first suture channel 11. After the suture 4 is cut, the entire vascular closure device can be removed. It should be understood that the third direction is not limited to a straight line direction. In other embodiments, the third direction can also be a direction with a certain arc or bend. Therefore, the cutting channel 13 is not limited to extending in a straight line. It can also present a certain arc or bend shape, which will not affect the movement of the cutter head 61 and the cutting of the suture 4. The third direction is not limited to being perpendicular to the first direction or the second direction. As long as the third direction can form an angle with the first direction or the second direction, it can be achieved.

[0070] Optionally, the first suture channel 11 has a first end 111 and a second end 112 along the second direction; the extension width of the blade head 61 along the second direction at least covers the first end 111 and does not exceed the second end 112 at most. 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 extension width of the blade head 61 along the second direction at least covers the first end 111, it can be understood that the suture 4 can be reliably cut when it is as close to the first end 111 as possible along the x-axis direction. In an alternative exemplary embodiment, the extension width of the blade head 61 along the second direction exceeds the first end 111 by at least 0.5 mm to ensure reliable coverage of the first suture channel 11 at the first end 111 and ensure the reliability of cutting.

[0071] On the other hand, the extension width range of the cutter head 61 along the second direction does not exceed the second end 112 at most, which can ensure that the cutter head 61 will not extend out of the first suture channel 11 during cutting, avoiding danger. In one embodiment, the extension width range of the cutter head 61 along the second direction can be at a certain distance relative to the second end 112 to reduce the risk of misoperation of the cutting assembly 6. The suture 4 cannot be cut at all width positions in the first suture channel 11 along the x-axis direction, but can only be cut 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 to ensure normal use. Optionally, a cutting range mark is provided on the substrate 1, and the cutting range mark corresponds to the extension width range of the cutter head 61 along the second direction.

[0072] 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 base 1 for abutting against the target tissue 5, and the cutting channel 13 intersects with the first section 113. The cutting channel 13 intersects with the first section 113, that is, the position where the suture 4 is cut is located in the first section 113, that is, the section close to the target tissue 5. With such a configuration, the section of the suture 4 squeezed and deformed by the knob 2 is located at the end of the cutting point away from the target tissue 5, which will not affect the subsequent removal of the suture 4, and avoid the risk of blockage in the tissue caused by the squeezed and deformed section of the suture 4. At the same time, the cutting position of the suture 4 conforms to clinical usage habits.

[0073] Optionally, the cutting assembly 6 also includes a reset member 62, which is used to reset the cutter head 61. For example, it can apply potential force to the cutter head 61 to achieve resetting. The cutter 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 it is not subjected to external force. The provision of the reset member 62 effectively improves the reliability of the cutting assembly 6 and reduces erroneous cutting caused by false triggering. The reset member 62 may include an elastic member (such as a spring) or a magnetic member (such as a group of magnets with the same poles opposite), etc., which can, for example, apply an elastic force or a magnetic force to the cutter head 61 in a direction away from the first suture channel 11, so that the cutter head 61 is in a position away from the first suture channel 11 when it is not pressed.

[0074] In an alternative exemplary embodiment, the cutting assembly 6 further includes a button 63, which can be fixedly connected to the cutter head 61, and the reset member 62 includes a spring, and the two ends of the spring are respectively connected to the button 63 and the base 1. When performing cutting, the operator presses the button 63 to drive the cutter head 61 to move along the y-axis. At this time, the spring is compressed to store potential energy. After the cutter 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, driving the cutter head 61 to return to a position away from the first suture channel 11.

[0075] For further information, please refer to Fig.16 and Fig.17 , the cutting assembly 6 also includes a protective member 64, which switches between a protective state and a release state; when the protective member 64 is in the protective state, the cutter head 61 is prevented from moving in the cutting channel 13; when the protective member 64 is in the release state, the restriction on the cutter head 61 is released to allow the cutter head 61 to move in the cutting channel 54. In an exemplary embodiment, the protective member 64 is movably inserted in the base 1 along the z-axis or the x-axis, and is in a protective state when it moves along the z-axis or the x-axis to overlap with the y-direction position of the button 63. At this time, the movement of the button 63 along the y-axis is blocked by the protective member 64 and cannot be pressed, so that the cutter head 61 is equivalent to being limited and cannot move along the cutting channel 54 to cut the suture 4. Avoid accidental touch when cutting is not desired, and protect the suture 4. When the protective member 64 moves along the z-axis or x-axis to be offset from the y-axis position of the button 63, the protective member 64 is in a released state, which removes the obstruction to the movement of the button 63, so that the cutter head 61 can move freely along the cutting channel 54 to cut the suture 4. When it is desired to cut, the operator can, for example, pull the protective member 64 out of the base 1, thereby switching the protective member 64 to the released state, and then cut.

[0076] Please refer to Fig.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 edge. The setting of the concave-convex structure 7 can, on the one hand, effectively tighten the suture 4 and improve the squeezing effect on the suture 4, and on the other hand, increase the stretching distance of the suture 4 under the same outer diameter of the knob 2. Of course, in some other embodiments, the outer peripheral wall of the knob 2 and / or the cavity wall of the knob accommodating cavity 12 can also be cylindrical, that is, a smooth wall surface, to simplify the design.

[0077] Optionally, the blood vessel closing device provided in this embodiment further includes a suture 4 , one end or the folded end of the suture 4 is used for suturing and fixing to the target tissue 5 , and the other end or the free end of the suture 4 is used for passing through the first suture channel 11 and the second suture channel 21 .

[0078] In summary, the blood vessel closing device provided by the present invention comprises: a base, a knob and a pressure detection unit; The base has a first suture channel arranged along a first direction and a knob accommodating cavity arranged along a second direction, the first suture channel penetrates and communicates with the knob accommodating cavity; the knob has a second suture channel, the knob is rotatably arranged in the knob accommodating cavity around a rotation axis extending along the second direction, and a gap is provided 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 passed through the aligned first suture channel and the second suture channel; when the knob is configured to rotate from the initial position to the locking position, the suture in the second suture channel is driven to be misaligned with the suture in the first suture channel, thereby pulling the suture into the gap to form a retraction of the suture; the base is configured to compress the target tissue under the retraction of the suture; the pressure detection unit is configured to be directly or indirectly squeezed by the suture when the knob is rotated from the initial position to the locking position, thereby obtaining the pressure of the base on the target tissue. With such configuration, after the suture is inserted into the first suture channel and the second suture channel, the suture can be retracted by turning the knob, and the retraction of the suture causes the base to be pressed down to form pressure on the target tissue. Furthermore, by setting up the pressure detection unit, the pressure of the base on the target tissue can be detected in real time, and it can be clearly known whether the suture is broken or the pressure is too large, thereby improving the convenience and safety of the vascular closure device.

[0079] It should be noted that the above embodiments can be combined with each other. The above description is only a description of the preferred embodiments of the present invention, and does not limit the scope of the present invention. Any changes and modifications made by ordinary technicians in the field of the present invention based on the above disclosure are within the protection scope of the present invention.

Claims

1. A blood vessel closure device, characterized in that: include: Base body, knob and pressure detection unit; 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 penetrates and communicates with the knob accommodating cavity; the knob has a second suture channel, the knob is rotatably arranged in the knob accommodating cavity, and a gap is formed between the knob and the cavity wall of the knob accommodating cavity; When the knob is in the initial position, the second suture channel is aligned with the first suture channel, allowing the suture to be movably inserted into the aligned first suture channel and the second suture channel; 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 rotating from the initial position to the locking position, thereby pulling the suture into the gap to form a retraction of the suture; The base is configured to compress the target tissue under the pulling action 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 locking position, thereby obtaining the pressure of the matrix on the target tissue.

2. The blood vessel closing device according to claim 1, characterized in that: The pressure detection unit includes a mechanical pressure detection assembly, and the mechanical pressure detection assembly includes a pressure measuring piece and a potential energy piece; The pressure measuring element is configured to move under the compression of the suture and to balance with the potential force of the potential energy element; the potential force corresponding to the movement of the pressure measuring element is the pressure of the matrix on the target tissue.

3. The blood vessel closing device according to claim 2, characterized in that: The mechanical pressure detection assembly further includes a shaft body, and the pressure measuring member is connected to the shaft body along the radial direction of the shaft body; The knob has a shaft body accommodating cavity and a pressure measuring member 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; The pressure measuring piece avoidance cavity extends circumferentially around the rotation axis and is in communication with the second suture channel; The pressure measuring member is configured to rotate around the rotation axis in the pressure measuring member avoidance cavity under the pressure of the suture to drive the shaft body to rotate; the direction of the potential force applied by the potential energy member to the pressure measuring member is opposite to the rotation direction of the pressure measuring member when it is squeezed by the suture; The potential energy corresponding to the rotation amount of the shaft and the pressure measuring member is the pressure of the substrate on the target tissue.

4. The blood vessel closing device according to claim 3, characterized in that: The knob has a potential energy component accommodating cavity, and the mechanical pressure detection assembly also includes a connecting member; The connecting member is connected to the shaft body along the radial direction of the shaft body and can be movably accommodated in the potential energy member accommodating cavity; the potential energy member is accommodated in the potential energy member accommodating cavity, one end of the potential energy member is connected to the connecting member, and the other end of the potential energy member is connected to the cavity wall of the potential energy member accommodating cavity.

5. The blood vessel closing device according to claim 4, characterized in that: The pressure measuring member avoidance cavity and the pressure measuring member are located within the range of the second suture channel in the second direction; the potential energy member accommodating cavity and the connecting member are located outside the range of the second suture channel in the second direction.

6. The blood vessel closing device according to claim 3, characterized in that: The mechanical pressure detection assembly also includes a pointer. The shaft extends out of the knob along one end away from the second suture channel and is connected to the pointer. The pointer is used to indicate the rotation angle of the shaft.

7. The blood vessel closing device according to claim 2, characterized in that: When the pressure measuring member is not squeezed by the suture, the pressure measuring member is in an initial position; when the pressure measuring member is squeezed by the suture, the pressure measuring member drives the potential energy member to store potential energy; when the pressure measuring member is released from pressure, the potential energy member releases the stored potential energy and drives the connecting member to return to the initial position.

8. The blood vessel closing device according to claim 2, characterized in that: The potential energy component includes an elastic potential energy component or a magnetic potential energy component; the elastic potential energy component includes a spring, a spring, a coil spring, silicone or rubber; the magnetic potential energy component includes a group of magnets with the same poles facing each other.

9. The blood vessel closing device according to claim 1, characterized in that: The pressure detection unit includes an electronic pressure detection component, and the electronic pressure detection component is arranged at at least one of the following locations: The substrate has a side that is in contact with the target tissue; The second suture channel is used for the side in contact with the suture.

10. The blood vessel closing device according to claim 1, characterized in that: The blood vessel closing device further comprises a suture, one end or the folded end of the suture is used for suturing and fixing to the target tissue, and the other end or the free end of the suture is used for passing through the first suture channel and the second suture channel.

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