CN112107342B

CN112107342B - Blood flow control devices

Info

Publication number: CN112107342B
Application number: CN201910536189.9A
Authority: CN
Inventors: 张金旻; 刘意抒; 张文丽; 刘辉; 肖亮; 严新谊; 黄启科; 刘福晨; 郭兴刚; 邵雪晴; 董伟; 孙玉明
Original assignee: Second Military Medical University SMMU
Current assignee: Second Military Medical University SMMU
Priority date: 2019-06-19
Filing date: 2019-06-19
Publication date: 2025-01-24
Anticipated expiration: 2039-06-19
Also published as: CN112107342A

Abstract

A blood flow control device comprises a sheath tube with a receiving portion, a blood vessel fixing piece with a locking end and a free end, and a control component, wherein the control component can control the blood vessel fixing piece to move in a first direction relative to the sheath tube, so that the blood vessel fixing piece received in the receiving portion is exposed and deformed to bend and circumferentially surround the blood vessel to be blocked, and the locking end of the blood vessel fixing piece can be locked to the sheath tube to form a locking ring to circumferentially lock the blood vessel, and the free end can move in both directions relative to the sheath tube under the control of the control component to adjust the ring diameter of the locking ring, and then adjust the pressure applied to the blood vessel, so as to achieve the purpose of controlling the blood flow rate in the blood vessel.

Description

Blood flow control apparatus

Technical Field

The embodiment of the application relates to the field of medical equipment, in particular to a blood flow control instrument for controlling the blood flow velocity in blood vessels.

Background

In the surgical operation, when the tissue and the organ with rich blood flow are treated, in order to avoid excessive bleeding in the operation process, the blood supply of the tissue is reduced by controlling the blood flow rate of the main blood vessels of the tissue and the organ, so that the risk of excessive bleeding of the target tissue and the organ in the operation process is reduced. For example, in liver resection procedures, the risk of bleeding during the liver resection procedure is often reduced by blocking portal blood flow.

At present, a method of controlling blood flow of a target blood vessel is often used clinically by exposing the blood vessel to be controlled through surgical dissection, wrapping the target blood vessel with a flexible wrapping wire, and pressing the target blood vessel by tightening the wrapping wire, and the other method is to control blood flow of the target blood vessel by clamping the target blood vessel with hemostatic forceps.

However, the current blood flow control operation of the blood vessel still has the following defects that 1, no matter the operation is performed by using a winding wire or a clamp, the operation becomes difficult under a cavity lens due to the extremely large limit of an operation space, a plurality of operations which possibly have major bleeding are limited to be successfully and safely completed under the cavity lens, 2, the operation of controlling the blood flow by using the clamp possibly damages the blood vessel and cannot effectively achieve the purpose of controlling the blood flow, 3, the clamp head part has insufficient curvature and cannot perform the clamp operation on the target blood vessel with a special structure, and if the curvature of the clamp head part is overlarge, the operation hole of the cavity lens cannot be smoothly passed, so that the application under the cavity lens is limited. 4. In order to enable the wound wire to wrap the target blood vessel under the endoscope, a plurality of steps of operation are needed, and the increased operation difficulty and operation risk limit the application range of the method under the endoscope.

In view of the foregoing, it would be desirable to provide a blood flow control device that can control device curvature during surgery and encircle a target blood vessel to control blood flow to the blood vessel, and in particular to provide a surgical assistance device that meets the limitations of endoscopic operating conditions.

Disclosure of Invention

In view of the above problems, a primary object of the present application is to provide a blood flow control apparatus and an operation method thereof, which have the advantages of convenient operation and accurate blood flow control by locking a target blood vessel circumferentially to slow down the blood flow velocity in the blood vessel or completely block the blood flow in the blood vessel.

It is another object of the present application to provide a blood flow control device and method of operating the same that can control the curvature of the device used to wrap around a blood vessel and that can be adapted for endoscopic surgical procedures.

An embodiment of the present application provides a blood flow control device for controlling a flow rate of blood in a blood vessel, comprising a sheath having a receiving portion formed therein and having a distal opening at a distal end of the sheath, a blood vessel fixing member slidably mounted in the sheath and having locking ends and free ends at opposite ends, respectively, wherein the blood vessel fixing member is receivable in the receiving portion of the sheath or is exposable to the sheath to be bent and deformed circumferentially around the blood vessel, the locking ends for detachably locking the blood vessel fixing member circumferentially around the blood vessel to form a locking ring, and a control member for controlling movement of the blood vessel fixing member in a first direction or a second direction opposite to the first direction relative to a body of the sheath, wherein the locking member is moved in the receiving portion in a direction of the sheath relative to the sheath by the locking member, the locking member being moved in a direction of the sheath relative to the sheath by the locking member by the control member being moved in a direction of the sheath, the locking member being moved in a direction of the sheath to the sheath by the locking member being moved in a direction of the sheath, the locking member being moved in a direction of the sheath fixing member by the sheath being moved in a direction of the sheath, thereby controlling the flow rate of blood flow within the vessel.

Optionally, in an embodiment of the present application, when the control component controls the free end of the vascular fastener to move in the second direction relative to the sheath, the ring diameter of the locking ring gradually decreases, the pressure exerted by the locking ring on the blood vessel gradually increases, thereby gradually slowing down the flow rate of blood in the blood vessel or completely blocking the flow of blood in the blood vessel, and when the control component controls the free end of the vascular fastener to move in the first direction relative to the sheath, the ring diameter of the locking ring gradually increases, the pressure exerted by the locking ring on the blood vessel gradually decreases, thereby gradually increasing the flow rate of blood in the blood vessel.

Optionally, in an embodiment of the present application, a sheath locking element is further provided on the sheath, and the sheath locking element detachably locks the locking end of the vascular fixing element to form the locking ring.

Optionally, in an embodiment of the present application, a locking position and a releasing position are further provided on the sheath locking element, where the locking end and the sheath locking element are locked with each other when the locking end is located at the locking position, and the locking end and the sheath locking element are separable from each other when the locking end is located at the releasing position.

Optionally, in an embodiment of the present application, the locking end is provided with a first magnetic attraction element, and the locking position of the sheath locking element is provided with a second magnetic attraction element, so that the locking end is positioned on the locking position of the sheath locking element by using a magnetic attraction principle.

Optionally, in an embodiment of the present application, the sheath locking element further comprises a switch unit for providing interlocking or separating of the locking end and the sheath locking element from each other.

Optionally, in an embodiment of the application, the control assembly further comprises a driving member for providing a driving force to drive the vascular fixing member to move relative to the sheath in the first direction.

Optionally, in an embodiment of the present application, the control assembly further includes a control body fixedly connected to the sheath, a sliding member disposed in the control body and fixedly connected to the free end of the vascular fixing member, the sliding member being bi-directionally movable relative to the control body along an axial direction of the control body to drive the free end of the vascular fixing member to move relative to the sheath, and a locking member switchable between a released state and a locked state, thereby defining a movement stroke of the sliding member relative to the control body, wherein the sliding member is movable relative to the control body when the locking member is switched to the released state, and is positioned at a predetermined position of the control body when the locking member is switched to the locked state.

Optionally, in an embodiment of the present application, the control assembly further comprises a control body having a lumen extending axially through the control body, the lumen having a non-circular lumen cross section, the control body being circumferentially rotatable relative to the sheath, a limiting member movably disposed at a proximal end of the sheath and detachably mounted within the lumen of the control body, the limiting member having a limiting member cross section adapted to the lumen cross section for circumferential rotation of the limiting member relative to the sheath with the limiting member being rotatable relative to the control body, the limiting member further having a first limiting member, and a sliding member extending through the lumen and having a first end and a second end at opposite ends of the sliding member, wherein the first end is exposed to the control body at a proximal end of the control body, the second end is fixedly connected to the free end of the vascular fastener via the proximal end of the sheath, the sliding member being further axially movable relative to the sheath relative to the limiting member by either the first end and the sliding member or the limiting member, and the sliding member being further axially movable relative to the sheath, the sliding piece can move in a bidirectional free way towards the first direction or the second direction relative to the sheath tube, and when the first limiting part of the limiting piece and the second limiting part on the sliding piece are in a mutually locked state, the sliding piece can move in a unidirectional way towards the second direction relative to the sheath tube only by applying a force to the first end.

Optionally, in an embodiment of the present application, the second limiting portion of the sliding member further includes a segmented limiting structure, for providing segmented displacement and positioning of the sliding member relative to the sheath in the second direction.

Alternatively, in an embodiment of the present application, the limiting member and the sliding member may be separately detachable from the control body, so as to detach the control body from the blood flow control apparatus.

Optionally, in an embodiment of the present application, the vascular fixing member is a hollow member, and the blood flow control apparatus further includes a guide member that may be inserted into the vascular fixing member and provide a predetermined bending shape, and the guide member is used to facilitate the vascular fixing member to be removed from the receiving portion, and the vascular fixing member exposed to the sheath may be bent and deformed according to the predetermined bending shape of the guide member.

Optionally, in an embodiment of the present application, the blood flow control apparatus further includes a pressure adjusting member disposed on an inner ring of the locking ring so as to be interposed between the locking ring and the blood vessel, the pressure adjusting member being configured to balance the pressure applied to different positions of the blood vessel and to finely adjust the pressure applied to the blood vessel.

Optionally, in an embodiment of the present application, the pressure adjusting member is a capsule.

Optionally, in an embodiment of the present application, the blood flow control apparatus further includes a reversing structure, the reversing structure having a first inlet, a second inlet, a first outlet, and a reversing unit for providing switching between a first transmission state and a second transmission state, wherein when the reversing unit is switched to the first transmission state, the first inlet and the first outlet are axially parallel to form a first transmission channel, and when the reversing unit is switched to the second transmission state, the second inlet and the first outlet are axially parallel to form a second transmission channel.

Optionally, in an embodiment of the present application, the blood flow control apparatus further includes an electronic control assembly having a setting unit for providing a set maximum pressure threshold, an alarm unit for outputting an alarm signal, a pressure sensing unit for sensing the pressure applied to the blood vessel by the locking ring formed by the blood vessel fixing member and outputting a pressure sensing value, and a control unit for receiving the pressure sensing value outputted by the pressure sensing unit and analyzing whether the pressure sensing value exceeds the maximum pressure threshold, and causing the alarm unit to output the alarm signal when the pressure sensing value is analyzed to exceed the maximum pressure threshold.

Optionally, in an embodiment of the present application, the electronic control unit further includes a timer for providing a timer and outputting a corresponding timer value, wherein the setting unit further includes providing a set maximum operation time, and the control unit further includes receiving the timer value output by the timer and, when the timer value is analyzed to exceed the maximum operation time, making the alarm unit output the alarm signal.

The application also provides an operation method of the blood flow control device, which comprises the steps of providing the blood flow control device, enabling the blood vessel fixing piece of the blood flow control device to be contained in the containing part of the sheath tube, enabling the blood vessel fixing piece to be controlled to move in the first direction relative to the sheath tube by means of the control component when the blood flow control device reaches the position of the blood vessel to be blocked, enabling the locking end of the blood vessel fixing piece to extend out of the sheath tube through the distal opening, enabling the blood vessel fixing piece to be pushed out of the containing part to be exposed out of the sheath tube, enabling the blood vessel fixing piece exposed out of the containing part to generate bending deformation to circumferentially surround the blood vessel, enabling the locking end of the blood vessel fixing piece to be locked to the sheath tube, enabling the blood vessel fixing piece circumferentially surround the blood vessel to form a locking ring, enabling the blood vessel to be locked to the locking ring, enabling the locking end of the blood vessel to be controlled to move in the free end of the blood vessel fixing piece to extend out of the sheath tube through the distal opening, enabling the locking end of the blood vessel fixing piece to be controlled to move in the second direction relative to the sheath tube, enabling the blood flow to be completely blocked, enabling the locking end of the blood vessel fixing piece to be locked to be completely locked to the sheath tube to move in the direction relative to the sheath tube, enabling the blood flow to be completely blocked, enabling the locking end of the blood vessel to be completely locked to flow to be blocked.

According to the technical scheme, the blood vessel fixing piece accommodated in the sheath tube is moved to be exposed, so that the exposed blood vessel fixing piece is bent and deformed to circumferentially surround the blood vessel, the locking end of the blood vessel fixing piece is locked on the sheath tube to form the locking ring, the blood vessel is circumferentially locked in the locking ring, then the free end of the blood vessel fixing piece is controlled to move relative to the sheath tube, and the pressure of the locking ring applied to the blood vessel is adjusted by adjusting the ring diameter of the locking ring, so that the purposes of slowing down the blood flow velocity in the blood vessel or completely blocking the blood flow in the blood vessel are achieved, the technical effect of accurately controlling the blood flow velocity in the blood vessel is achieved, the curvature of an instrument for winding the blood vessel can be controlled, and the blood vessel locking device has the advantages of convenience in operation and small damage and is particularly suitable for endoscopic surgery.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments described in the embodiments of the present application, and other drawings may be obtained according to these drawings for a person having ordinary skill in the art.

FIGS. 1-3 are schematic views of a blood flow control device according to an embodiment of the present application in different use states;

FIGS. 4A and 4B are side views of a blood flow control device of the present application;

FIG. 5 is a schematic view of an embodiment of a blood flow control device of the present application forming a locking ring;

FIGS. 6A and 6B are schematic views of another embodiment of a blood flow control device of the present application forming a locking ring;

FIGS. 7A and 7B are schematic illustrations of an embodiment of a guide of the present application;

FIGS. 8A-8E are schematic illustrations of a blood flow control device according to another embodiment of the present application in various states of use;

FIG. 9 is a schematic view of an embodiment of a pressure regulating member of the present application;

Fig. 10A and 10B are schematic views of an embodiment of the reversing structure of the present application, and

Fig. 11A is a schematic structural arrangement diagram of an electronic control unit according to the present application, and fig. 11B is a schematic system architecture diagram of the electronic control unit.

Element labels

1. Blood flow control apparatus

11. Sheath tube

110. Storage part

111. Distal end of sheath tube (distal opening)

112. Sheath tube locking piece (locking groove)

112A lock hole

1121. Locking position

1121A spacing convex part

11211. Second magnetic element

1122. Release position

1123. Switch unit

11231. Toggle piece

11232. Spring bolt

113. Proximal end of sheath tube (proximal opening)

12. Vascular fixing piece

120. Locking ring

121. Locking end

121A limiting groove

121B lock cylinder

121C locking groove

1211. First magnetic element

122. Free end

13. Control assembly

131. Driving piece

132. Control body

1321. Axial cavity

133. Sliding piece

1331. Connecting part

1332. Piston

134. Locking piece

135. Limiting piece

1351. A first limiting part

136. Sliding piece

1361. First end

1363. A second limiting part

13641/13642 Sectional limit part (sectional limit structure)

13641A/13642a guide surfaces

13641B/13642b defining surfaces

14. Guide piece

15. Pressure regulating member

161. A first inlet

162. A second inlet

163. A first outlet

164. Reversing unit

17. Electronic control assembly

171. Setting unit

172. Alarm unit

173. Pressure sensing unit

174. Control unit

175. Time-piece

2. Blood vessel

Detailed Description

In order to better understand the technical solutions in the embodiments of the present application, the following description will clearly and completely describe the technical solutions in the embodiments of the present application with reference to the accompanying drawings in the embodiments of the present application, and it is obvious that the described embodiments are only some embodiments of the present application, not all embodiments. All other embodiments, which are derived by a person skilled in the art based on the embodiments of the present application, shall fall within the scope of protection of the embodiments of the present application.

Referring to fig. 1 to 3 and fig. 4A and 4B, fig. 1 to 3 are perspective views of a blood flow control device 1 according to the present application in different usage states. Fig. 4A and 4B are schematic side views showing the blood flow control device 1 in different use states. As shown, the blood flow control device 1 of the present application is mainly used for controlling the blood flow velocity of a blood vessel 2, and mainly comprises a sheath tube 11, a blood vessel fixing member 12 and a control assembly 13.

The sheath 11 is hollow and has a receiving portion 110 formed therein, a distal opening 111 is formed at a distal end (i.e., an end far from an operator) of the sheath 11, and a proximal opening 113 is also formed at a proximal end (i.e., an end near the operator) of the sheath 11.

The vessel fixing member 12 is slidably fitted in the sheath 11 and is bi-directionally movable with respect to the body of the sheath 11 along the axial direction of the sheath 11, i.e., a first direction F1 shown in fig. 4A and 4B or a second direction F2 opposite to the first direction. In this embodiment, the vessel fixing member 12 may be integrally received in the receiving portion 110 of the sheath 11, or may be moved relative to the body of the sheath 11 in the first direction F1 when driven by an external force (e.g., a driving member 131 described below) so as to protrude from the interior of the sheath 11 through the distal opening 111 of the sheath 11, and be partially or integrally exposed to the sheath 11, and the exposed vessel fixing member 12 may be bent and deformed to circumferentially surround the vessel 2 to be blocked (as shown in fig. 1).

In another embodiment, the vascular fixing member 12 may be configured as a hollow tube, and the blood flow control device 1 further includes a guiding member 14 that may be disposed in the vascular fixing member 12, where the guiding member 14 is, for example, a rigid structure and is used to provide a predetermined bending configuration, and the guiding member 14 may be used to push the vascular fixing member 12 out of the receiving portion 110, and enable the vascular fixing member 12 exposed out of the sheath 11 to generate bending deformation along with the predetermined bending configuration provided by the guiding member 14 disposed inside the vascular fixing member 12, so that the bending deformation generated by the vascular fixing member 12 is as expected, so as to be suitable for various blood vessels having a specific structure.

Furthermore, the two ends of the vascular fixing member 12 are respectively provided with a locking end 121 and a free end 122. Wherein, in the case that the vessel fixing member 12 is exposed to the sheath 11, the locking end 121 is detachably locked to the sheath 11, so that the vessel fixing member 12 circumferentially surrounding the blood vessel 2 forms a locking ring 120, thereby circumferentially locking the blood vessel 2 to be blocked in the formed locking ring 120 (the state shown in fig. 2).

In the present application, the sheath 11 is further provided with a sheath locking element 112 which is detachably locked with the locking end 121 of the vessel fixing element 12 to form a locking ring 120, and in one embodiment, a locking position 1121 and a releasing position 1122 are further provided on the sheath locking element 112, wherein when the locking end 121 is located at the locking position 1121, the locking end 121 is locked with the sheath locking element 112, and when the locking end 121 is located at the releasing position 1122, the locking end 121 is separated from the sheath locking element 112. Specifically, referring to fig. 5, the sheath locking element 112 is, for example, a locking groove 112 disposed on a wall of the sheath 11, and a locking position 1121 and a release position 1122 are disposed in the locking groove 112, wherein a limit protrusion 1121A is disposed at the locking position 1121, and correspondingly, a limit groove 121A is disposed at the locking end 121 of the vessel fixing element 12, and the locking end 121 of the vessel fixing element 12 can be inserted into the locking groove 112 through the release position 1122 and slide from the release position 1122 to the locking position 1121, so that the limit protrusion 1121A of the locking groove 112 and the limit groove 121A of the locking end 121 are engaged with each other, thereby locking the locking end 121 in the locking groove 112. Conversely, when the locking end 121 of the vascular fixing member 12 slides from the locking position 1121 to the releasing position 1122 in the locking groove 112, the locking end 121 can be disengaged from the locking groove 112 because the engaging state between the limiting protrusion 1121A of the locking groove 112 and the limiting groove 121A of the locking end 121 is released. In an embodiment of the present application, the locking end 121 of the vessel fixing member 12 is further provided with a first magnetic element 1211, and a second magnetic element 11211 is further provided at the locking position 1121 of the sheath locking member 112, so that the locking end 121 is positioned at the locking position 1121 of the sheath locking member 112 by using the magnetic principle, and cannot easily slide from the locking position 1121 to the releasing position 1122, so as to ensure that the vessel 2 is firmly locked to the locking ring 120 circumferentially during the operation.

It should be noted that, the structure of the sheath locking element 112 is not limited to the above, and in other embodiments, the sheath locking element 112 may also include a switch unit 1123 for providing the locking end 121 and the sheath locking element 112 to be locked to each other or separated from each other. Specifically, referring to fig. 6A and 6B, the sheath locking member 112 includes a locking hole 112A disposed on a wall of the sheath 11, the switch unit 1123 further includes a toggle member 11231 and a locking tongue 11232 disposed in the locking hole 112, the locking end 121 of the vessel fixing member 12 further includes a locking post 121B, an outer diameter of the locking post 121B is adapted to an aperture of the locking hole 112A, a locking groove 121C is formed on the locking post 121B, and a force is applied to the toggle member 11231 to retract the locking tongue 11232 to open the interior of the locking hole 112A, so that the locking post 121B of the locking end 121 can be inserted into the locking hole 112A, and then the force applied to the toggle member 11231 is released, so that the locking tongue 11232 returns to the original position and is engaged with the locking groove 121C of the locking post Yu Suozhu B, thereby locking the locking post 121B in the locking hole 112A of the sheath locking member 112. In addition, the locking post 121B of the locking end 121 may be disengaged from the locking hole 112A of the sheath locking member 112 by applying a force to the toggle member 11231 to retract the locking tongue 11232 and release the engaged state between the locking tongue 11232 and the locking groove 121C.

The control assembly 13 is used for controlling the vascular fixing member 12 to move along the axial direction of the sheath 11 in the first direction F1 or in the second direction F2 opposite to the first direction with respect to the body of the sheath 11. In this embodiment, the vessel fixing member 12 is integrally received in the receiving portion 110 of the sheath 11 in the initial use state, and at this time, the physician can operate the control unit 13 to move the vessel fixing member 12 relative to the body of the sheath 11 in the first direction, so that the locking end 121 of the vessel fixing member 12 protrudes from the sheath 11 through the distal opening 111 of the sheath 11 to push the vessel fixing member 12 out of the receiving portion 110 and expose the vessel fixing member to the sheath 11. Referring to fig. 4A and 4B, in the present embodiment, the control unit 13 further includes a driving member 131 for providing a driving force to drive the vascular fixing member 12 to move in the first direction F1 relative to the sheath 11. The driving member 131 is, for example, a spring disposed inside the sheath 11, so as to push the blood vessel fixing member 12 out of the accommodating portion 110 by using an elastic restoring force of the spring (please describe below).

In addition, in the case where the locking end 121 of the vascular fixing member 12 is locked to the sheath 11 to form the locking ring 120, the control unit 13 is operated to control the free end 122 of the vascular fixing member 12 to move in the first direction F1 or the second direction F2 relative to the sheath 11, so as to adjust the ring diameter of the locking ring 120, thereby adjusting the pressure applied to the blood vessel 2 by the locking ring 120, and thus controlling the blood flow rate in the blood vessel. Specifically, when the free end 122 of the vascular mount 12 is controlled by the control unit 13 to move in the second direction F2 (i.e., the direction approaching the operator) relative to the sheath 11, the ring diameter of the locking ring 120 is gradually reduced, so that the pressure exerted on the blood vessel 2 by the locking ring 120 is gradually increased, thereby gradually slowing down the flow rate of blood in the blood vessel 2 or completely blocking the flow of blood in the blood vessel 2 (the state shown in fig. 3). Conversely, when the free end 122 of the vascular mount 12 is controlled by the control assembly 13 to move in the first direction F1 (i.e., away from the operator) relative to the sheath 11, the loop diameter of the locking ring 120 gradually increases, such that the pressure exerted by the locking ring 120 on the blood vessel 2 gradually decreases, thereby gradually increasing the blood flow velocity within the blood vessel 2 (i.e., gradually restoring the blood flow velocity within the blocked blood vessel 2).

In one embodiment, the control assembly 13 includes a control body 132, a sliding member 133 and a locking member 134. Wherein the control body 132 is fixedly connected to the sheath 11, and an operator can perform related operations with respect to the instrument by grasping the control body 132 at an appropriate position.

The sliding member 133 is disposed in the control body 132 and is fixedly connected to the free end 122 of the vascular fixing member 12, wherein the sliding member 133 can move bi-directionally along the axial direction of the control body 132 relative to the control body 132 to drive the free end 122 of the vascular fixing member 12 to move relative to the body of the sheath 11. As shown in fig. 4A and 4B, in the present embodiment, the sliding member 133 is, for example, a sliding member, and has a connecting portion 1331 fixedly connected to the free end 122 at one end, and in the present embodiment, the connecting portion 1331 may be disposed inside the sheath 11 and located between the free end 122 and the driving member 131. The other end of the slider 133 further includes a piston 1332 disposed within the control body 132 to drive the slider 133 to smoothly move relative to the control body 132 by means of the piston 1332.

The locking member 134 is switchable between a release state and a locking state for limiting a movement stroke of the slider 133 with respect to the control body 132, wherein the slider 133 (piston 1332) is movable with respect to the control body 132 when the locking member 134 is switched to the release state, and the slider 133 (piston 1332) is positioned at a predetermined position of the control body 132 when the locking member 134 is switched to the locking state. Furthermore, the locking member 134 may be in a locked state, and the driving member (spring) 131 may be in a compressed state, so that when the locking member 134 is switched from the locked state to the released state, the driving member (spring) 131 in the compressed state is released, and the connecting portion 1331 of the sliding member 133 pushes the blood vessel fixing member 12 in the accommodating portion 110 to move towards the first direction F1 by virtue of the elastic restoring force provided by the driving member 131, so as to be exposed out of the sheath 11.

With continued reference to fig. 8A to 8E, in another embodiment of the present application, the control device 13 further includes a control body 132, a limiting member 135, and a sliding member 136.

The control body 132 has an interior with a lumen 1321 extending axially through the control body 132, wherein the lumen 1321 has a non-circular lumen cross-section and the control body 132 is rotatable circumferentially relative to the sheath 11.

The limiting member 135 is movably connected to the proximal end 113 of the sheath 11 and is detachably embedded in the shaft cavity 1321 of the control body 132 (as shown in fig. 8E), wherein the limiting member 135 has a limiting member cross section adapted to the shaft cavity cross section, so that when the limiting member 135 is embedded in the shaft cavity 1321, the limiting member 135 can synchronously rotate circumferentially relative to the sheath 11 along with the circumferential rotation of the control body 132 relative to the sheath 11, and a first limiting portion 1351 is further provided on the limiting member 135. In the present embodiment, the shaft cavity section of the shaft cavity 1321 and the limiting member section of the limiting member 135 may be configured as a hexagon, but not limited thereto, and may be configured as other non-circular sections.

The sliding member 136 is disposed through the shaft cavity 1321 of the control body 132, and the control body 132 can rotate circumferentially relative to the sliding member 136, and the opposite ends of the sliding member 136 are respectively provided with a first end 1361 and a second end (not shown), wherein the first end 1361 of the sliding member 136 extends out of the shaft cavity 1321 at the proximal end (i.e., near the operator) of the control body 132 and is exposed out of the control body 132, the second end of the sliding member 136 sequentially passes through the limiting member 135 and the proximal opening 113 of the sheath 11 to enter the interior of the sheath 11 and is fixedly connected to the free end 122 of the vascular fixing member 12, and the sliding member 136 is circumferentially fixed relative to the sheath 11, i.e., the sliding member 136 cannot rotate circumferentially relative to the body of the sheath 11, but can move in the first direction F1 or the second direction F2 relative to the body of the sheath 11 along the axial direction of the sheath 11, wherein the connection between the second end of the sliding member 136 and the free end 122 can refer to the embodiment shown in fig. 4A and 4B. In addition, a second limiting portion 1363 is further provided on the slider 136.

The operator can operate the control body 132 to perform circumferential rotation relative to the sheath 11 to drive the limiter 135 embedded in the shaft cavity 1321 to perform circumferential rotation relative to the body of the sheath 11, as described above, since the slider 136 is circumferentially fixed relative to the body of the sheath 11, when the limiter 135 performs circumferential rotation relative to the body of the sheath 11, the limiter 136 also performs circumferential rotation relative to the slider 136, so that the first limiter 1351 of the limiter 135 and the second limiter 1363 on the slider 136 are engaged with or released from each other, wherein when the first limiter 1351 of the limiter 135 and the second limiter 1363 on the slider 136 are in the released state, the slider 136 can move bi-directionally relative to the sheath 11 in the first direction F1 or the second direction F2, and when the first limiter 1351 of the limiter 135 and the second limiter 1363 on the slider 136 are in the locked state (i.e. the state shown in fig. 8B), the slider 136 can move unidirectionally relative to the sheath 11 only by applying the sheath force to the first end 1361 of the slider 136.

In an embodiment, the second limiting portion 1363 of the sliding member 136 further includes a segmented limiting structure for providing the sliding member 136 with a segmented displacement and positioning in the second direction F2 with respect to the sheath 11. Specifically, as shown in fig. 8B, a plurality of segment limiting portions 13641/13642 are provided in the segment limiting structure, each segment limiting portion 13641/13642 has a guiding surface 13641a/13642a and a limiting surface 13641B/13642B, respectively, wherein when a force is applied to the first end 1361 of the slider 136 to move along the second direction F2 in a state that the first limiting portion 1351 of the limiting member 135 and the second limiting portion 1363 of the slider 136 are locked with each other, the guiding surface 13642a of the segment limiting portion 13642 is used to guide the first limiting portion 1351 of the limiting member 135 to move from the segment limiting portion 13642 to the segment limiting portion 13641, and when the force applied to the first end 1361 is released, the first limiting portion 1351 of the limiting member 135 abuts against the limiting surface 13641B of the segmented limiting portion 13641, and the limiting surface 13641B limits the first limiting portion 1351 of the limiting member 135 to move reversely from the segmented limiting portion 13641 to the segmented limiting portion 13642, so that only the unidirectional displacement and the segmented positioning of the sliding member 136 relative to the sheath 11 are provided, and the ring diameter of the locking ring 120 formed by the vascular fixing member 12 is gradually reduced, so that the pressure of the locking ring 120 applied to the blood vessel 2 is precisely controlled (i.e., the state shown in fig. 8C is gradually converted to the state shown in fig. 8D), and the blood flow velocity in the blood vessel 2 is gradually slowed down until the blood flow in the blood vessel 2 is completely blocked. In this embodiment, the segmented limiting structure is, for example, a limiting rack disposed on the slider 136.

Furthermore, the limiting member 135 and the sliding member 136 of the present application can be separated from the shaft cavity 1321 of the control body 132, respectively, so that the control body 132 can be detached from the blood flow control apparatus 1 by a doctor alone when the blocking state of the vascular fixing member 12 against the blood vessel 2 is expected during the operation, thereby facilitating the subsequent operation. The slider 136 is made of, for example, a soft material.

With continued reference to fig. 9, in another embodiment of the present application, the blood flow control device 1 further includes a pressure adjusting member 15 disposed on an inner ring of the locking ring 120 formed by the blood vessel fixing member 12 and sandwiched between the locking ring 120 and the blood vessel 2 to be blocked, so that the pressure applied to different positions of the blood vessel 2 by the pressure adjusting member 15 tends to be balanced, thereby achieving the effects of finely adjusting the blocking pressure of the blood vessel fixing member 12 on the blood vessel 2 and making the circumferential stress of the blood vessel 2 uniform. In the present embodiment, the pressure adjusting member 15 may be designed as a balloon, such as a water balloon structure or an air balloon structure.

Referring to fig. 10A and 10B in combination, in another embodiment, the blood flow control apparatus 1 further includes a reversing structure, wherein the reversing structure has a first inlet 161, a second inlet 162, a first outlet 163, and a reversing unit 164, wherein the reversing unit 164 is configured to provide switching between a first transmission state and a second transmission state, wherein when the reversing unit 164 is switched to the first transmission state, the first inlet 161 and the first outlet 163 are axially parallel to form a first transmission channel, and when the reversing unit 164 is switched to the second reversing state, the second inlet 162 and the first outlet 163 are axially parallel to form a second transmission channel. Specifically, when performing the operation, the reversing unit 164 may be first switched to the first transmission state (as shown in fig. 10A), such that the first inlet 161 and the first outlet 163 are axially parallel to form a first transmission channel, in which state the components such as the sheath 11, the vascular fixing member 12, and the guide member 14 of the blood flow control device 1 may be inserted into the body cavity of the patient through the first transmission channel, and since the guide member 14 is of a rigid structure, the vascular fixing member 12 may smoothly reach the position of the blood vessel 2 to be blocked under the guidance of the guide member 14, and at the same time, the vascular fixing member 12 may be caused to protrude from the housing 110 by the guide member 14 to be exposed to the sheath 11, and the exposed vascular fixing member 12 may be completely deformed by the guide member 14 to circumferentially surround the blood vessel 2 to be blocked, and after the locking end 121 of the vascular fixing member 12 is locked to the outer sheath 11 to form the locking ring 120, the guide member 14 may be withdrawn through the first transmission channel. The reversing unit 164 may then be switched to a second transmission state (i.e., the state shown in fig. 10B) such that the second inlet 162 is axially parallel to the first outlet 163 to form a second transmission channel through which other laparoscopic surgical instruments may be passed into the body cavity of the patient.

With continued reference to fig. 11A and 11B, in the present embodiment, the blood flow control apparatus 1 further includes an electronic control unit 17 having a setting unit 171, an alarm unit 172, a pressure sensing unit 173, and a control unit 174.

The setting unit 171 is used for providing a maximum pressure threshold value preset by an operator, that is, providing a maximum pressure value that the vascular fastener 12 can apply to the blood vessel 2 to be blocked, so as to prevent the blood vessel 2 from being damaged due to excessive pressure. The alarm unit 172 is used for outputting an alarm signal. The pressure sensing unit 173 may be disposed, for example, at an inner ring of the blood vessel fixing member 12, for sensing the amount of pressure applied to the blood vessel 2 by the locking ring 120 formed by the blood vessel fixing member 12, and outputting a corresponding pressure sensing value. The control unit 174 is configured to receive the pressure sensing value outputted by the pressure sensing unit 173, analyze whether the sensed pressure sensing value exceeds the maximum pressure threshold set by the setting unit 171, and when the received pressure sensing value exceeds the maximum pressure threshold, cause the alarm unit 172 to output an alarm signal to prompt the operator to adjust the ring diameter of the locking ring 120 in time.

In another embodiment, a timer 175 may be further provided in the electronic control unit 17 for providing a timer and outputting a corresponding timer value. The operator can also preset a maximum operation time, that is, the maximum time that the blood vessel 2 is in the blocking state, by the setting unit 171, when the blocking operation of the blood vessel 2 is completed, the timer 175 starts to count and outputs a corresponding count value to the control unit 174, so that the control unit 174 can output an alarm signal to remind the operator to adjust the ring diameter of the locking ring 120 in time when the current count value is analyzed to exceed the preset maximum operation time.

The operation method of the blood flow control device 1 of the present application mainly comprises providing a blood flow control device 1, wherein the vessel fixing member 12 of the blood flow control device 1 is accommodated in the accommodating portion 110 of the sheath 11 in an initial state. When the blood flow control device 1 reaches the blood vessel 2 to be blocked, the control component 13 can control the blood vessel fixing member 12 to move towards the first direction F1 relative to the sheath 11, so that the locking end 121 of the blood vessel fixing member 12 protrudes from the sheath 11 through the distal opening 111, and the blood vessel fixing member 12 is pushed out of the accommodating portion 110 to be exposed out of the sheath 11. Then, the vessel fixing member 12 exposed out of the sheath 11 can be bent and deformed to circumferentially surround the vessel 2 to be blocked, and then the locking end 121 of the vessel fixing member 12 is locked to the sheath 11, so that the vessel fixing member 12 circumferentially surrounding the vessel 2 forms a locking ring 120, and the vessel 2 to be blocked is circumferentially locked in the formed locking ring 120. Then, the control component 13 is used to control the free end 122 of the vascular fixing component 12 to move towards the second direction F2 relative to the sheath 11, so that the loop diameter of the formed locking loop 120 is gradually reduced, and the vascular occlusion operation is performed on the blood vessel 2 to be occluded, so as to slow down the blood flow velocity in the blood vessel 2 or completely occlude the blood flow in the blood vessel. When the vascular occlusion operation for the blood vessel 2 is completed, the control unit 13 can be used to control the free end 122 of the vascular fixing member 12 to move towards the first direction F1 relative to the sheath 11, and the locking end 121 of the vascular fixing member 12 is separated from the sheath 11, so as to release the circumferential locking state of the vascular fixing member 12 for the blood vessel 2, thereby restoring the blood flow velocity in the blood vessel 2.

In one embodiment, when the blood vessel blocking operation is performed by using the blood flow control device 1 shown in fig. 1 to 4B, the sheath 11 of the blood flow control device 1 and the blood vessel fixing member 12 disposed therein are moved to the position of the blood vessel 2 to be blocked in the patient's body through the first transmission channel formed by the reversing structure, then the operator can remove the blood vessel fixing member 12 from the housing portion 110 through the distal opening 111 of the sheath 11 to be exposed to the sheath 11 under the driving of the driving member 131 by switching the locking member 134 to the release state, and the exposed blood vessel fixing member 12 can be bent and deformed to circumferentially surround the blood vessel 2 to be blocked (as shown in fig. 1 and 4B), and then the locking end 121 of the blood vessel fixing member 12 is locked to the sheath locking member 112 of the sheath 11 to form the locking ring 120 to circumferentially lock the blood vessel 2 to be blocked therein, thereby completing the preset operation of the blood flow control device 1 (as shown in fig. 2).

When cutting organ tissues, an operator can slide the piston 1332 in the control body 132 (i.e. move the piston 1332 towards the second direction F2 relative to the control body 132) to drive the free end 122 of the vascular fixing member 12 to move towards the second direction F2 relative to the sheath 11, so that the ring diameter of the locking ring 120 formed by the vascular fixing member 12 is gradually reduced, and the ring diameter of the locking ring 120 can be controlled by adjusting the state of the locking member 134 and the sliding stroke of the piston 1332 in the control body 132, thereby adjusting the blood flow velocity in the blood vessel 2. The operator can then achieve a sustained occlusion of the vessel 2 by switching the locking member 134 from the released state to the locked state (as shown in fig. 3). When the vascular occlusion procedure is completed, the operator switches to the released state by opening the locking member 134 externally, so that the free end 122 of the vascular anchor 12 is movable relative to the sheath 11 in the first direction F1, thereby restoring blood supply to the blood vessel 2. The evacuation of the vessel anchor 12 is then accomplished by releasing the locking between the locking end 121 of the vessel anchor 12 and the sheath locking 112.

In another embodiment, when the blood vessel blocking operation is performed by using the blood flow control device 1 shown in fig. 6A, 6B and 8A to 8E, the sheath 11 of the blood flow control device 1 and the blood vessel fixing member 12 disposed therein are moved to the position of the blood vessel 2 to be blocked in the patient's body by the first transmission channel formed by the reversing structure, and then the blood vessel fixing member 12 is pushed to be moved out of the receiving portion 110 through the distal opening 111 of the sheath 11 to be exposed to the sheath 11, the exposed blood vessel fixing member 12 is bent and deformed to circumferentially surround the blood vessel 2 to be blocked, and then the locking end 121 of the blood vessel fixing member 12 is locked to the sheath locking member 112 of the sheath 11 to form the locking ring 120 to circumferentially lock the blood vessel 2 to be blocked therein, thereby completing the preset operation of the blood flow control device 1 (the state shown in fig. 8C).

When cutting organ tissue, an operator can rotate the control body 132 to enable the limiting member 135 embedded in the shaft cavity 1321 of the control body 132 to rotate circumferentially relative to the sliding member 136, so that the first limiting portion 1351 on the limiting member 135 and the second limiting portion 1363 on the sliding member 136 are aligned (locked with each other), when the first end 1361 of the sliding member 136 is pulled towards the second direction F2, the sliding member 136 can be moved towards the second direction F2 relative to the sheath 11, so as to drive the free end 122 of the vascular fixing member 12 to move unidirectionally towards the second direction F2 relative to the sheath 11, so that the ring diameter of the locking ring 120 formed by the vascular fixing member 12 is gradually reduced, and by positioning the first limiting portion 1351 on the limiting member 135 in the different segmented limiting portions 13642 of the second limiting portion 1363, the ring diameter of the locking ring 120 can be controlled, thereby adjusting the blood flow velocity in the blood vessel 2, and thus continuous blocking of the blood vessel 2 can be realized (as shown in fig. 8D). At this time, the operator can remove the control body 132 from the blood flow control apparatus 1, and only the sliding member 136 extends out of the body along the first transmission channel, so as to facilitate the subsequent operation, and the first limiting portion 1351 on the limiting member 135 and the second limiting portion 1363 on the sliding member 136 are in a unidirectional self-locking state, so that the blood vessel 2 can be ensured to be blocked during the operation.

When the vascular occlusion operation is finished, the control body 132 can be replaced along the sliding member 136, so that the limiting member 135 is re-embedded in the shaft cavity 1321 of the control body 132, and the control body 132 is rotated in vitro, so that the first limiting portion 1351 of the limiting member 135 and the second limiting portion 1363 of the sliding member 136 can be unlocked mutually, so that the free end 122 of the vascular fixing member 12 can move towards the first direction F1 relative to the sheath 11, and the blood supply state in the blood vessel 2 can be restored. The evacuation of the vessel anchor 12 is then accomplished by releasing the locking between the locking end 121 of the vessel anchor 12 and the sheath locking 112.

In summary, according to the blood flow control device of the present application, the exposed vascular fixing member is bent and deformed and locked to the outer sheath to form the locking ring, so that the blood vessel to be blocked is locked circumferentially, and then the control assembly is operated to move the free end of the vascular fixing member relative to the sheath tube, so as to adjust the ring diameter of the locking ring formed, and further adjust the pressure of the locking ring applied to the blood vessel to be blocked, thereby achieving the purpose of slowing down the blood flow velocity in the blood vessel or completely blocking the blood flow in the blood vessel, and achieving the technical effect of precisely controlling the blood flow velocity in the blood vessel.

In addition, after the blood flow blocking operation for the blood vessel is completed, the control body can be cut off from the blood flow control device so as to be convenient for subsequent operation, and the reversing structure is used for switching between the first transmission channel and the second transmission channel so as to be used for respectively placing related components of the blood flow control device or other laparoscopic surgical devices.

It should be noted that the above-mentioned embodiments are merely for illustrating the technical solutions of the embodiments of the present application, and not for limiting the same, and although the present application has been described in detail with reference to the above-mentioned embodiments, it should be understood by those skilled in the art that the technical solutions described in the above-mentioned embodiments may be modified or some technical features may be equivalently replaced, and these modifications or substitutions do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. A blood flow control device for controlling blood flow velocity within a blood vessel, comprising:

a sheath tube, wherein a receiving part is formed in the sheath tube, and a distal end opening is formed at the distal end of the sheath tube;

A vessel fixing member slidably mounted in the sheath tube, and having locking ends and free ends at opposite ends, respectively, wherein the vessel fixing member is receivable in the receiving portion of the sheath tube or is exposed to the sheath tube to be bent and deformed so as to circumferentially surround the vessel, the locking ends are detachably locked to the sheath tube so that the vessel fixing member circumferentially surrounding the vessel forms a locking ring to circumferentially lock the vessel within the locking ring, and

A control assembly for controlling the vascular fastener to move in a first direction or a second direction opposite to the first direction relative to the body of the sheath along the axial direction of the sheath,

With the vessel fixing member received in the receiving portion, controlling the vessel fixing member to move in the first direction relative to the sheath by the control unit so that the locking end of the vessel fixing member protrudes from the sheath through the distal opening so that the vessel fixing member is exposed out of the sheath, and

In the case that the locking end is locked on the sheath tube to form the locking ring, the control component is used for controlling the free end of the blood vessel fixing piece to move towards the first direction or the second direction relative to the sheath tube so as to adjust the pressure of the locking ring on the blood vessel by adjusting the ring diameter of the locking ring, thereby controlling the blood flow velocity in the blood vessel.

2. The blood flow control device of claim 1, wherein:

When the control component controls the free end of the vascular fixing component to move towards the second direction relative to the sheath pipe, the ring diameter of the locking ring is gradually reduced, the pressure exerted on the blood vessel by the locking ring is gradually increased, thereby gradually slowing down the blood flow velocity in the blood vessel or completely blocking the blood flow in the blood vessel;

when the control assembly controls the free end of the vascular mount to move relative to the sheath in the first direction, the loop diameter of the locking loop gradually increases, and the pressure exerted by the locking loop on the blood vessel gradually decreases, thereby gradually increasing the blood flow rate within the blood vessel.

3. The blood flow control device of claim 1, wherein the sheath is further provided with a sheath locking element that detachably locks the locking end of the vascular fastener to form the locking ring.

4. A blood flow control device according to claim 3 and also having a locking position and a release position on the sheath locking element, wherein the locking end is interlocked with the sheath locking element when the locking end is in the locking position and the locking end is separable from the sheath locking element when the locking end is in the release position.

5. The blood flow control device of claim 4, wherein the locking end is provided with a first magnetic element and the locking position of the sheath locking element is provided with a second magnetic element to position the locking end in the locking position of the sheath locking element using a magnetic principle.

6. A blood flow control instrument according to claim 3, wherein the sheath locking further comprises a switch unit for providing interlocking or separation of the locking end and the sheath locking.

7. The blood flow control device of claim 1, wherein the control assembly further comprises a drive member for providing a drive force to drive the vascular mount to move relative to the sheath in the first direction.

8. The blood flow control device of claim 1 or 7, wherein the control assembly further comprises:

the control body is fixedly connected with the sheath tube;

A sliding member arranged in the control body and fixedly connected with the free end of the vascular fixing member, wherein the sliding member can move bidirectionally relative to the control body along the axial direction of the control body so as to drive the free end of the vascular fixing member to move relative to the sheath tube, and

A locking member switchable between a released state and a locked state, thereby defining a travel of movement of the slider relative to the control body, wherein the slider is movable relative to the control body when the locking member is switched to the released state, and is positioned at a predetermined position of the control body when the locking member is switched to the locked state.

9. The blood flow control device of claim 1 or 7, wherein the control assembly further comprises:

a control body having an axial lumen extending axially therethrough, the axial lumen having a non-circular axial lumen cross-section, the control body being circumferentially rotatable relative to the sheath;

A limiting member movably arranged at the proximal end of the sheath tube and detachably embedded in the shaft cavity of the control body, wherein the limiting member has a limiting member section matched with the shaft cavity section so that the limiting member can rotate relative to the sheath tube along with the control body in a circumferential direction, a first limiting part is further arranged on the limiting member, and

The sliding piece is arranged in the shaft cavity in a penetrating way and is provided with a first end and a second end which are positioned at two opposite ends of the sliding piece, wherein the first end extends out of the control body at the proximal end of the control body, the second end is fixedly connected with the free end of the blood vessel fixing piece through the proximal end of the sheath tube so as to ensure that the sliding piece is circumferentially fixed relative to the sheath tube, a second limiting part is also arranged on the sliding piece, the sliding piece can move along the axial direction of the sheath tube relative to the sheath tube in the first direction or the second direction,

The control body is controlled to circumferentially rotate relative to the sheath tube so as to drive the limiting piece to circumferentially rotate relative to the sliding piece, so that the first limiting portion of the limiting piece and the second limiting portion on the sliding piece are mutually clamped or mutually released, when the first limiting portion of the limiting piece and the second limiting portion on the sliding piece are in a mutually released state, the sliding piece can move in a bidirectional and free mode relative to the sheath tube in the first direction or the second direction, and when the first limiting portion of the limiting piece and the second limiting portion on the sliding piece are in an interlocking state, the sliding piece can move in a unidirectional mode relative to the sheath tube only by exerting force on the first end.

10. The blood flow control device of claim 9, wherein the second defining portion of the sled further comprises a segmented spacing structure for providing segmented displacement and positioning of the sled relative to the sheath in the second direction.

11. The blood flow control device of claim 9, wherein the limiter and the slider are each detachable from the control body to remove the control body from the blood flow control device.

12. The blood flow control device of claim 1, wherein the vascular mount is a hollow member and the blood flow control device further comprises a guide member that is insertable into the vascular mount and provides a predetermined curved configuration, the guide member being configured to facilitate removal of the vascular mount from the receptacle and to permit bending of the vascular mount exposed to the sheath in response to the predetermined curved configuration of the guide member.

13. The blood flow control device of claim 1, further comprising a pressure adjustment member disposed on an inner circumference of the locking ring so as to be interposed between the locking ring and the blood vessel, the pressure adjustment member being configured to balance the pressure applied to different locations of the blood vessel and to finely adjust the amount of pressure applied to the blood vessel.

14. The blood flow control device of claim 13, wherein the pressure regulating member is a bladder.

15. The blood flow control device of claim 1, further comprising a reversing structure having a first inlet, a second inlet, a first outlet, and a reversing unit for providing a switch between a first transmission state and a second transmission state, wherein when the reversing unit is switched to the first transmission state, the first inlet is axially parallel to the first outlet to form a first transmission channel, and when the reversing unit is switched to the second transmission state, the second inlet is axially parallel to the first outlet to form a second transmission channel.

16. The blood flow control device of claim 1, further comprising an electronic control assembly having:

A setting unit for providing a set maximum pressure threshold;

an alarm unit for outputting an alarm signal;

A pressure sensing unit for sensing the pressure applied to the blood vessel by the locking ring formed by the blood vessel fixing member and outputting a pressure sensing value, and

And the control unit is used for receiving the pressure sensing value output by the pressure sensing unit, analyzing whether the pressure sensing value exceeds the maximum pressure threshold value, and enabling the alarm unit to output the alarm signal when the pressure sensing value exceeds the maximum pressure threshold value.

17. The blood flow control device of claim 16, wherein the electronic control assembly further comprises a timer for providing a timing and outputting a corresponding timing value, wherein,

The setting unit further includes providing a set maximum operation time, and the control unit further includes receiving the count value output by the timer, and causing the alarm unit to output the alarm signal when it is analyzed that the count value exceeds the maximum operation time.