A brachial artery access abdominal aorta blood flow protection device

Abstract

The present invention relates to a brachial artery access abdominal aorta blood flow protection device, belonging to the technical field of medical devices. It comprises a protective umbrella device arranged at the end away from the operator, a plastic tube for recovering or releasing the protective umbrella device, and an operating handle close to the operator; the operating handle is movably connected to one end of the plastic tube, and the plastic tube is provided with a manipulation rod for moving the plastic tube; a pull wire for tightening and shrinking the protective umbrella is provided in the protective umbrella device, and a pull wire tube and a guide sheath are passed through the plastic tube; the pull wire passes through the pull wire tube and is connected to a pull wire valve arranged on the operating handle. The present invention can be applied to blood flow protection in interventional treatment surgeries at the proximal end of the abdominal aorta; it can be used to solve the problem of debris shedding and embolism of the renal artery and lower limb artery caused by thrombectomy, and prevent adverse events such as renal insufficiency and "garbage feet".

Description

Technical Field

[0001] The invention relates to a brachial artery access abdominal aorta blood flow protection device, belonging to the technical field of medical devices. Background Art

[0002] Superior mesenteric artery embolism or thrombosis is a relatively common emergency in clinical practice. However, the current thrombectomy operation during vascular surgery is prone to produce thrombus debris, which is transported through the abdominal aorta and embolizes the renal arteries and small arteries in the distal lower limbs. The carotid artery supplies brain tissue. When performing carotid stenting on patients with carotid artery stenosis, serious adverse events such as stroke caused by debris shedding are taken into consideration. Relatively mature cerebral blood flow protection devices are available in clinical practice. The body tissues supplied by small arteries in the lower limbs are toes and other parts, which will not cause serious disability or lethal consequences and have not received enough attention. Although the thrombectomy operation may embolize the renal artery and cause serious adverse consequences, there is no corresponding distal blood flow protection device in clinical practice due to the fast blood flow velocity and high pressure in the abdominal aorta. Therefore, there is an urgent need for an abdominal aorta blood flow protection device in this technical field. Summary of the invention

[0003] The purpose of the present invention is to solve the technical problem of how to obtain an abdominal aorta blood flow protection device.

[0004] In order to achieve the purpose of solving the above-mentioned problems, the technical solution adopted by the present invention is to provide an abdominal aorta blood flow protection device for brachial artery access, including a protective umbrella device arranged at an end away from the operator, a plastic tube for recovering or releasing the protective umbrella device, and an operating handle close to the operator; the operating handle is movably connected to the end of the plastic tube close to the operator, and the end of the plastic tube close to the operator is provided with an operating rod for moving the plastic tube; a pull wire for tightening and shrinking the protective umbrella is provided in the protective umbrella device, and a pull wire tube and a guide sheath are passed through the plastic tube; the pull wire passes through the pull wire tube and is connected to a pull wire pull valve provided on the operating handle.

[0005] Preferably, the wire pulling tube and the guide sheath are arranged side by side and connected to each other; and the protective umbrella device is arranged at one end of the wire pulling tube away from the operator.

[0006] Preferably, a blood flow blocking valve is provided in the plastic tube.

[0007] Preferably, the operating handle is provided with a moving track for manipulating the pull rod to move forward and backward, thereby driving the plastic tube to move forward and backward.

[0008] Preferably, the protective umbrella device comprises a protective umbrella ring, an umbrella support rod, a dense net bag and a guide head; an umbrella support rod is provided between the guide head and the protective umbrella ring, and a dense net bag is covered between the guide head and the protective umbrella ring; the protective umbrella ring is configured as a disconnected circular ring, and the two disconnected ends are respectively configured as a fixed end and a free end; a pull wire is provided along the protective umbrella ring for tightening and shrinking the protective umbrella ring.

[0009] Preferably, the protective umbrella device is configured as a cone when opened, the guide head is the apex of the cone, and the protective umbrella ring is the bottom circumferential ring of the cone; the guide head is connected to the guide sheath.

[0010] Preferably, the protective umbrella ring is made of an elastic material with a shape memory function; the protective umbrella support rod is made of an elastic material with a shape memory function.

[0011] Preferably, a syringe connection port is provided at one end of the guide sheath close to the operator.

[0012] Compared with the prior art, the present invention has the following beneficial effects:

[0013] There is no abdominal aorta blood flow protection device in the prior art. The product provided by the present invention is particularly suitable for blood flow protection in interventional treatment surgery at the proximal end of the abdominal aorta. It can solve the problem of debris shedding and embolism of the renal artery and lower limb artery caused by thrombectomy, and prevent adverse events such as renal insufficiency and "garbage feet";

[0014] The present invention adopts a self-expanding support rod to solve the problem that the protective umbrella is not tightly attached to the arterial wall when it is released by impact force alone;

[0015] The present invention adopts a loop design, which can effectively tighten the protective umbrella, reduce the risk of thrombus spillage, and facilitate the recovery of the blood flow protection device;

[0016] The invention adopts the plastic tube operating pull rod and the pull wire pull valve design on the operable handle to effectively implement the recovery of the protective umbrella. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a schematic diagram of the structure of the present invention.

[0018] Figure 2 This is a schematic diagram of the structure of the present invention when it is released and working.

[0019] Figure 3 It is a schematic diagram of the structure of the present invention during recovery.

[0020] Figure 4 It is a schematic diagram of the structure of each specific component of the present invention.

[0021] Among them, B1 is the compressed and closed state diagram of the protective umbrella device; B2 is the naturally opened state diagram; D1 is the side view of the operating handle; D2 is the top view of the operating handle; L1 is the side view of the plastic tube; L2 is the top view of the plastic tube.

[0022] Figure 5 It is a working state process diagram of the present invention;

[0023] Figure 6 It is a schematic diagram of the structure of the protective umbrella device of the present invention.

[0024] Figure 7 This is a process diagram of the operating state of the operating handle of the present invention.

[0025] Figure numerals: 1. Arterial blood vessel wall; 2. Protective umbrella device; 3. Blood flow blocking valve; 4. Operating handle; 5. Guide head; 6. Hollow net bag; 7. Pull wire; 8. Pull wire valve; 9. Operating rod; 10. Moving track; 11. Guide sheath; 12. Syringe connection port; 13. Pull wire tube; 14. Plastic tube section of guide sheath; 15. Plastic tube; 16. Protective umbrella support rod; 17. Dense net bag; 18. Thrombus or intimal debris; 19. Loop; 20. Fixed end. DETAILED DESCRIPTION

[0026] In order to make the present invention more clearly understood, a preferred embodiment is described in detail with reference to the accompanying drawings as follows:

[0027] like Figure 1-7As shown, the technical solution adopted by the present invention is to provide a brachial artery access abdominal aorta blood flow protection device, including a protective umbrella device 2 arranged at an end away from the operator, a plastic tube 15 for retracting and releasing the protective umbrella device 2, and an operating handle 4 near the operator; the operating handle 4 is movably connected to the end of the plastic tube 15 near the operator, and the plastic tube 15 is provided with an operating rod 9 for moving the plastic tube 15; a pull wire 7 is provided in the protective umbrella device 2, and a pull wire tube 13 and a guide sheath 11 are passed through the plastic tube 15; the pull wire 7 passes through the pull wire tube 13 and is connected to a pull wire valve 8 arranged on the operating handle 4. A blood flow blocking valve 3 is provided in the plastic tube 15. A moving track 10 is provided on the operating handle 4 for operating the pull rod 9 to move forward and backward to drive the plastic tube 15 to move forward and backward. The protective umbrella device 2 comprises a protective umbrella ring 19, a protective umbrella support rod 16, a dense net bag 17 and a guide head 5; a protective umbrella support rod 16 is arranged between the guide head 5 and the protective umbrella ring 19, and a dense net bag 17 covers the guide head 5 and the protective umbrella ring 19; the protective umbrella ring 19 is set as a broken circular ring, and the two broken ends are respectively set as a fixed end 20 and a free end; a pull line 7 for tightening and shrinking the protective umbrella ring 19 is arranged along the protective umbrella ring 19. When the protective umbrella device 2 is opened, it is set as a cone, the guide head 5 is the apex of the cone, and the protective umbrella ring 19 is the bottom circumferential ring of the cone. The protective umbrella ring 19 is made of an elastic material with a shape memory function; the protective umbrella support rod 16 is made of an elastic material with a shape memory function. A syringe connection port 12 is arranged at the end of the guide sheath 11 close to the operator.

[0028] Example

[0029] When clinical vascular surgeons use thrombectomy catheters and other instruments to perform interventional thrombectomy on the superior mesenteric artery, the thrombus may be torn, broken and detached. The abdominal aorta blood flow protection device provided by the present invention can be used for brachial artery access, and can effectively capture the thrombus or intimal debris 18 that has fallen off the superior mesenteric artery during interventional surgery to remove the thrombus, thereby reducing the risk of tissue ischemia and necrosis caused by embolism of small arteries in the distal lower limbs.

[0030] The overall working view of the abdominal aorta blood flow protection device provided by the present invention is as follows: Figure 1-3 As shown, Figure 1 This is a guide image for the device’s transbrachial artery approach; Figure 2 This is a working diagram of the release of the abdominal aorta blood flow protection device; Figure 3 This is a schematic diagram of the recovery of the abdominal aorta blood flow protection device; Figure 1 The present invention shown in FIG. 1 includes a protective umbrella device 2 in the arterial blood vessel wall 1, a blood flow blocking valve 3 in the plastic tube 15, and an operating handle 4 at the end of the plastic tube 15 near the operator. Figure 4As shown, it includes a guide head 5, which is made of hard plastic. The protective umbrella device 2, whose head end is fixed on the guide head 5, is composed of 9 plastic elastic support rods 16 and a dense net bag 17, and the mesh diameter is about 200-250um. In the figure, B1 is the closed state of the protective umbrella device 2 after compression; B2 is the naturally open state of the protective umbrella device 2. The outer edge of the hollow net bag 6 of the protective umbrella device 2 is provided with a protective umbrella ring 19 that can tighten the hollow net bag 6, and the inside of the protective umbrella ring 19 is provided with a strong pull wire 7 with a fixed end 20 at the head end. When the pull wire 7 is tightened, the ring 19 can be slowly closed. A pull wire pull valve 8 is provided on the operating handle 4, and the pull wire 7 passing through the inside of the hollow ring 19 is fixed on it. By pulling out the pull wire pull valve 8, the pull wire 7 in the hollow ring 19 can be tightened. Figure 4 D1 is a side view of the operating handle; D2 is a top view of the operating handle; the operating handle 4 is also provided with a plastic tube 15 to operate the pull rod 9 for tightening the protective umbrella. After the protective umbrella device 2 reaches the specified position, the operating pull rod 9 is pulled toward the operator to release the protective umbrella device 2. A moving track 10 for the operating pull rod 9 is provided on the operating handle 4. A guide sheath 11 is provided in the plastic tube 15, and a guide wire or other working guide wire can be inserted into the guide sheath 11. The end of the guide sheath 11 close to the operator is provided as a syringe connection port 12; a wire pull tube 13 and a plastic tube section 14 of the guide sheath 11 are provided in the plastic tube 15; the outer diameter of the plastic tube 15 to which the operating pull rod 9 is fixed is approximately 4-4.5F, Figure 4 L1 is a side view of the plastic tube; L2 is a top view of the plastic tube, wherein the plastic tube 15 has a rectangular groove in the middle, through which the pull wire 7 can pass and be connected to the pull wire valve 8.

[0031] The working scenario of the protective umbrella device 2 in the body is as follows Figure 5 As shown, Figure I is a guidance diagram of the device entering through the brachial artery, and the protective umbrella device 2 is placed at the designated position along the blood flow direction of the abdominal aorta; Figure II is a release working diagram of the abdominal aorta blood flow protection device, and the thrombus or intimal debris 18 detached from the upstream interventional operation is captured by the hollow net bag 6; Figure III is a schematic diagram of the recovery of the abdominal aorta blood flow protection device, after pulling the pull wire and pulling the valve 8 to tighten the loop 19, push the plastic tube 15 to the end away from the operator and pull back the guide sheath 11 to recover the protective umbrella device after entrapping the thrombus into the sheath tube.

[0032] The state of the blood vessels opened by the protective umbrella device is as follows Figure 6As shown in FIG. I, II, and III, a protective umbrella ring 19 is tightly attached to the inner side of the aortic vessel wall 1, and the protective umbrella device 2 includes 9 elastic support rods 16, a dense net bag 17, and a guide head 5; the guide head 5 is connected to the guide sheath 11; a pull wire 7 is arranged inside the protective umbrella ring 19, and the protective umbrella ring 19 is circular in its natural state, and the protective umbrella ring 19 is composed of a circular arc segment and is provided with two separated ends; one end of the circular arc segment of the ring 19 is fixed to the end of the wire pulling tube 13 as a fixed end 20, and the other end is movably connected to the wire pulling tube 13 through the pull wire 7; one end of the pull wire 7 is fixed to the fixed end 20 at the end of the wire pulling tube 13, and the other end can be inserted into the wire pulling tube 13 with the free end of the ring 19, and the pull wire 7 is connected to the pull wire pull valve 8. When the pull wire 7 is pulled, the free end of the ring 19 enters the wire pulling tube 13, and the protective umbrella ring 19 shrinks.

[0033] Figure 7 It is a working flow chart of the operating handle 4 at the tail end, wherein Figure I is the initial state; Figure II is the released state of the abdominal aorta blood flow protection device, the plastic tube 15 is operated to pull the pull rod 9 backward to release the head end protection umbrella; Figure III is the tightened state of the abdominal aorta blood flow protection device loop, when retrieving the protection device, pull out the pull wire pull valve 8, and confirm under DSA angiography that the loop has been tightened; Figure IV is the retracted state of the blood flow protection device, push up the plastic tube 15 and pull back the guide sheath 11 to retract the protection umbrella device 2 after entrapping the thrombus into the sheath tube.

[0034] At present, there is no blood flow protection device for the abdominal aorta in clinical practice; the openings of existing arterial blood flow protection devices are much smaller than the inner diameter of the abdominal aorta and cannot be used; during interventional thrombectomy of the superior mesenteric artery, the detached thrombus is transported through the abdominal aorta and embolizes the renal artery and small arteries in the distal lower limbs, which will cause adverse events such as renal insufficiency, ischemia or necrosis of distal lower limb tissues, and a blood flow protection device for the abdominal aorta is urgently needed; since the blood flow impulse in the abdominal aorta is relatively large, the protective umbrella can be opened with the help of blood flow impulse and the principle of self-expansion, and the support rod can be used to ensure that the net bag fits tightly against the inner wall of the aorta; since the blood flow impulse is relatively large during retrieval, the protective umbrella is closed by tightening the loop pull line to prevent the overflow of thrombus during retrieval and help the protective umbrella to be smoothly retrieved.

[0035] The manufacturing and assembling process of the present invention:

[0036] 1) First, make the guide head 5 and the protective umbrella, insert the pull wire 7 into the loop 19 and fix the loop 19 on the protective umbrella;

[0037] 2) Making a plastic tube 15 and carving rectangular grooves at appropriate positions;

[0038] 3) manufacturing the guide sheath 11 and the syringe connection port 12 and completing the assembly;

[0039] 4) Making the operating handle 4 and the wire pull valve 8, and carving a rectangular groove at a suitable position of the operating handle 4;

[0040] 5) Assemble the guide head 5, the protective umbrella, the guide sheath 11 and the pull-wire tube 13, and store the protective umbrella in the plastic tube 15. To facilitate the opening of the protective umbrella, the ring 19 should not be tightened, and the protective umbrella is now in a compressed and tightened manner;

[0041] 6) Install the tail end of the plastic tube 15 into the operating handle 4, fix the plastic operating rod 9, connect the pull wire 7 and the pull wire valve 8 to complete the device.

[0042] The use process of the present invention:

[0043] For example, when performing interventional thrombectomy on the superior mesenteric artery, the device is first introduced through the brachial artery to the designated position: below the opening of the celiac trunk and above the opening of the renal artery, and the plastic tube 15 is pulled back to operate the pull rod 9, and the protective umbrella device 2 is released by the self-expansion force of the support rod 16 and the blood flow impulse; and then the subsequent interventional thrombectomy operation is performed through other arterial access routes;

[0044] After the interventional treatment is completed, the pull line and valve 8 are pulled out to tighten the protective umbrella ring 19, and then the operating rod 9 of the plastic tube 15 is pushed forward and the guide sheath 11 is pulled back to put the protective umbrella into the plastic tube 15. The plastic tube of the outer section of the blood vessel is pulled back until the device is completely recovered.

[0045] The above is only a preferred embodiment of the present invention, and is not any formal or substantial limitation of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the present invention, and these improvements and supplements should also be regarded as the protection scope of the present invention. Any technician familiar with this profession, without departing from the spirit and scope of the present invention, can make some changes, modifications and equivalent changes made by using the technical content disclosed above, which are equivalent embodiments of the present invention; at the same time, any changes, modifications and evolutions of any equivalent changes made to the above embodiments based on the essential technology of the present invention are still within the scope of the technical solution of the present invention.

Claims

1. A brachial artery access abdominal aorta blood flow protection device, characterized in that: The invention comprises a protective umbrella device arranged at an end away from an operator, a plastic tube for recovering or releasing the protective umbrella device, and an operating handle at an end close to the operator; the operating handle is movably connected to an end of the plastic tube close to the operator, and an operating rod for moving the plastic tube is arranged at an end of the plastic tube close to the operator; a pull wire for tightening and shrinking the protective umbrella is arranged in the protective umbrella device, and a pull wire tube and a guide sheath are passed through the plastic tube; the pull wire tube and the guide sheath are arranged side by side and connected to each other; the protective umbrella device is arranged at an end of the pull wire tube away from the operator; the pull wire passes through the pull wire tube and is connected to a pull wire valve arranged on the operating handle; The protective umbrella device comprises a protective umbrella ring, a protective umbrella support rod, a dense net bag and a guide head; a protective umbrella support rod is provided between the guide head and the protective umbrella ring, and a dense net bag is covered between the guide head and the protective umbrella ring; the protective umbrella ring is made of an elastic material with a shape memory function; the protective umbrella support rod is made of an elastic material with a shape memory function; the protective umbrella ring is set to be a broken circular ring, and the two broken ends are respectively set to be a fixed end and a free end, and the end of the protective umbrella ring fixed to the end of the pull tube is the fixed end; a pull wire for tightening and shrinking the protective umbrella ring is provided along the inside of the protective umbrella ring, one end of the pull wire is fixed to the fixed end, and the other end of the pull wire can be inserted into the pull tube with the free end of the protective umbrella ring, and when the pull wire is pulled, the free end of the protective umbrella ring enters the pull tube, and the protective umbrella ring shrinks, thereby tightening the dense net bag; The protective umbrella device is configured as a cone when opened, the guide head is the apex of the cone, and the protective umbrella ring is the bottom circumferential ring of the cone; the guide head is connected to the guide sheath.

2. The brachial artery access abdominal aorta blood flow protection device according to claim 1, characterized in that: A blood flow blocking valve is arranged in the plastic tube.

3. The brachial artery access abdominal aorta blood flow protection device according to claim 1, characterized in that: The operating handle is provided with a moving track for operating the pull rod to move forward and backward so as to drive the plastic pipe to move forward and backward.

4. The brachial artery access abdominal aorta blood flow protection device according to claim 1, characterized in that: The end of the guide sheath close to the operator is provided with a syringe connection port.

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