Drainage hemostasis device in support for treating cerebral hemorrhage
Through the use of an intrastent stimulation and suction flow hemostasis device, combined with an expandable stent and active high-frequency hemostasis device, the problems of hemostasis and hematoma removal in the acute phase of hemorrhagic stroke are solved, and minimally invasive, precise hemostasis and hematoma removal are achieved, reducing the risk of secondary bleeding.
Patent Information
- Application Number
- CN202311144035.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-09-06
- Publication Date
- 2025-03-07
AI Technical Summary
The prior art is difficult to perform effective hemostasis and hematoma removal in the acute phase of hemorrhagic stroke, resulting in increased surgical complexity and risk of secondary bleeding.
An intrastent flush suction flow hemostasis device is used, which includes an expandable stent, a flush catheter, a suction catheter and an active high frequency hemostasis device. Through the synergy between the water flow inside the stent and the high-frequency electrode, precise hemostasis of the bleeding points and removal of hematoma are achieved.
Minimally invasive, precise hemostasis and hematoma removal in the acute phase of hemorrhagic stroke are achieved, reducing the risk of secondary bleeding and improving the safety and effectiveness of the surgery.
Smart Images
Figure CN119564321A_ABST
Abstract
Description
Technical Field
[0001] The present technology relates to the technical field of surgical instruments for treating hemorrhagic stroke, and in particular to an intra-stent drainage hemostasis device for treating cerebral hemorrhage. Background Art
[0002] Hemorrhagic stroke refers to non-traumatic intraparenchymal hemorrhage. Recently, a variety of advanced surgical techniques, such as neuroendoscopy, neurosurgery keyhole, stereotactic aspiration technology, etc., combined with the continuous improvement of medical treatment programs, have made great progress in the treatment of hemorrhagic stroke. Hemorrhagic stroke is characterized by acute, critical, complex and easy to relapse. Surgical intervention should be carried out quickly. However, due to the complexity of neurosurgery, acute cerebral hemorrhage surgery faces the difficulty of handling extensive bleeding and the lack of understanding of the patient's family. Existing technology often needs to wait until the bleeding is initially stabilized before proceeding.
[0003] After hemorrhage, brain nerve damage deteriorates rapidly over time, so a surgical instrument is needed to carry out rescue as early as possible. The brain structure is complex, and nerve damage is difficult to repair, which is not suitable for large incision surgery. Minimally invasive surgery is the development trend of neurosurgery. The complex cerebral vascular network, improper or untimely hemostasis may even cause distal vascular ischemia. The operation of hemostatic instruments requires precision and does not affect the blood supply to the distal brain tissue. After cerebral hemorrhage, secondary bleeding is prone to occur after surgery due to factors such as the squeezing of brain tissue by the hematoma, the absorption and degeneration of damaged brain tissue, and changes in the permeability of the cerebral vascular structure. Surgery needs to solve the above-mentioned mechanical and brain tissue repair problems to reduce secondary bleeding.
[0004] In recent years, with the advancement of medical device technology, a surgical device has been developed that can be used in the acute stage of hemorrhagic stroke by combining implantable interventional devices, active hemostasis equipment, hemostasis materials, tissue engineering and various precision manufacturing processes. It can perform surgery as early as possible to save more brain nerve functions, reach the bleeding point with minimal invasion and precision to remove hematoma and stop bleeding, and repair brain structural mechanics. Summary of the invention
[0005] The purpose of the present invention is to provide an intra-stent drainage hemostasis device for treating cerebral hemorrhage, so as to solve the above technical problems.
[0006] To achieve the above purpose, the present invention adopts the following specific technical solutions:
[0007] A stent intra-brain suction hemostasis device for treating cerebral hemorrhage, characterized in that it comprises: Figure 1 As shown, the stent 101 at the front end of the device is connected to the flushing catheter and the suction catheter of the stent, wherein the flushing catheter is 102 and the suction catheter is 103; Figure 2As shown, the front end of the stent 201 is internally connected to a flushing tube 205, and the rear end is connected to a suction tube 202. The suction tube external interface 203 has a side hole inside the suction tube, and the sucked liquid flows out from the external interface through the suction tube port to the external drainage and pressure detection device. The end cap 204 is used to seal the connection between the flushing tube and the suction tube. The flushing and suction pipeline interface 206 is used to connect an external pressure-controlled flushing device. The flushing tube has a built-in guide wire 207 for inserting the stent into the hematoma center of cerebral hemorrhage during surgery. Figure 3 As shown, the flushing water flows out from the flushing tube 304 at the front end of the stent, driving the blood that has infiltrated from the side wall of the stent to flow out from the suction tube 305 at the rear end of the stent.
[0008] Further, such as Figure 3 As shown, the front end of the stent 303 is fixed on the arc-shaped smooth ball head 301, the ball head closes the front end of the stent, the flushing tube 304 is connected and fixed on the ball head rod, and the flushing tube mouth 302 is located inside the front end of the stent. The flushing and suction water flows inside the stent to the suction tube 305 at the rear end of the stent, driving the hematoma infiltrated from the side wall of the stent to flow out. The flushing and suction pressure of the water flow is limited to the inside of the stent to avoid acting on the brain tissue, forming a flushing and suction flow inside the stent. There is no need to open a side hole on the stent during drainage. The side wall of the stent is a non-tubular open hole structure. The hematoma penetrates into the stent through the mesh gap of the dense mesh stent. This design avoids the previous side hole drainage, which causes the suction pressure to be concentrated on the side hole.
[0009] Further, such as Figure 1 As shown, an active high-frequency hemostatic device 104 may be placed inside the stent 101; Figure 5 As shown, the active high-frequency hemostatic device has a metal electrode 502 on its surface, the hemostatic device is connected to a catheter 503, and the interior of the catheter has a pipeline 504 and a power line 505 connected to the electrode.
[0010] Further, such as Figure 4 As shown, the stent 401 is an expandable porous stent with a diameter of 0.1 mm to 5 mm before expansion, more preferably 0.5 mm to 2.5 mm. The device has a suction interface 402 and a flushing interface 403 for external piping.
[0011] Further, such as Figure 5 As shown, the active high-frequency hemostasis device has a front end of a balloon 501, and the balloon covers a multi-lumen tube 503. The multi-lumen tube has an inlet and outlet liquid pipeline 504 in the balloon, and the rear end of the multi-lumen tube is connected to a liquid inlet and outlet interface 506. The balloon surface electrode 502 is connected to the active energy device through a power cord 507 built into the multi-lumen tube. The cooling liquid enters the balloon through the multi-lumen tube to cool the balloon surface electrode and surrounding brain tissue.
[0012] Further, such as Figure 6As shown, the front end of the active high-frequency hemostasis device is a coagulation catheter with an arc-shaped convex head. The surface of the arc-shaped convex head 601 has an electrode 602, and the arc-shaped convex head is connected to a multi-lumen tube 603.
[0013] Furthermore, the flushing and suction tube can transport hemostatic materials for insertion into the stent to stop bleeding. The hemostatic materials inserted into the stent include but are not limited to powdered, gelatinous, liquid and solid hemostatic materials. The hemostatic materials are preferably liquid hemostatic materials that can coagulate after the high-frequency electrode outputs energy, such as various protein coagulants.
[0014] Further, such as Figure 7 As shown, after the active high-frequency balloon hemostasis device is placed into the stent through the suction tube, cooling liquid is injected through the balloon multi-lumen tube to expand the balloon 701 close to the stent 703. Between the brain tissue and the electrode 701, there is a stent 702, filled hemostatic material and exuded blood. The power supply is turned on to control the electrode to output energy so that the filled hemostatic material and exuded blood are coagulated on the stent, thereby sealing the brain bleeding point.
[0015] Furthermore, the active high-frequency hemostasis device electrode input frequency range is 3kHz-300MHz, preferably the frequency range is the radiofrequency ablation band of 300kHz-30MHz.
[0016] Further, such as Figure 8 As shown, the intra-stent flushing and suction hemostasis device for treating cerebral hemorrhage is characterized in that the flushing tube 802 is a bendable tube with a bending angle of 0° to 180°.
[0017] Compared with the prior art, the beneficial results of the present invention are as follows:
[0018] 1. Suitable for the acute stage of hemorrhagic stroke. In the acute stage of stroke, the bleeding points are still active. Performing slightly more invasive surgery may cause increased bleeding from the bleeding points. Even the minimally invasive stereotactic aspiration technology of the existing technology center cannot be applied to the acute stage because it cannot solve the problem of hemostasis. This solution uses an expandable stent internal flushing and suction flow technology that combines hemostasis with hematoma removal. In terms of hemostasis, the expanded stent can provide pressure to compress the bleeding points to stop bleeding, and an active high-frequency balloon inside the stent is used for synchronous hemostasis. In terms of hematoma removal, the hematoma penetrates into the stent mesh and is carried away by the water flow inside the stent. The combination of multiple technologies can achieve hemostasis and hematoma removal at the same time, making acute stage surgery of hemorrhagic stroke possible.
[0019] 2. Minimally invasive, precisely reach the bleeding point to remove the hematoma and stop bleeding. Minimally invasive hemorrhagic stroke surgery needs to meet the two aspects of small trauma and small changes in intracranial pressure. In this technology, the deep entrance of the brain tissue when the device is inserted is only 1 mm-2 mm. Hemorrhagic stroke patients are in a state of hypertension, and changes in intracranial pressure cause problems in other blood vessels. The water flow is limited to the stent to remove the hematoma, and the relatively closed structure avoids changes in intracranial pressure.
[0020] 3. Surgical device for repairing brain structural mechanics. The stent is an implantable device that combines the biological material filled inside to fill the hematoma cavity, repair the brain tissue structure, provide tissue mechanical support for blood vessels, and avoid secondary bleeding. BRIEF DESCRIPTION OF THE DRAWINGS
[0021] Figure 1 It is a schematic diagram of the overall structure of the intra-stent suction hemostasis device of the present invention;
[0022] Figure 2 It is a schematic diagram of the structure of the intra-stent flushing and drainage device of the present invention.
[0023] Figure 3 This is a schematic diagram of the head structure of the stent intra-flushing drainage device.
[0024] Figure 4 Schematic diagram of the expansion structure of the front end stent of the stent intra-stent drainage device.
[0025] Figure 5 This is a schematic diagram of the structure of the active high-frequency balloon hemostasis device.
[0026] Figure 6 This is a schematic diagram of the structure of the arc-shaped convex head high-frequency hemostasis device.
[0027] Figure 7 Schematic diagram of the high-frequency hemostatic balloon deployed within the stent.
[0028] Figure 8 This is a schematic diagram of the bendable flushing pipe structure.
[0029] Description of Figure Numbers.
[0030] 101 stent; 102 flushing catheter; 103 suction catheter; 104 active high-frequency hemostasis device; 203 suction tube external interface; 204 end cap; 206 flushing and suction pipeline interface; 207 guide wire; 301 ball head; 302 flushing tube mouth; 402 suction interface; 403 flushing interface; 501 balloon; 502 metal electrode; 503 connecting catheter; 504 pipeline; 505 power cord; 506 liquid inlet and outlet interface; 507 power cord; 601 arc convex head; 602 electrode; 603 multi-lumen tube; 802 bendable flushing tube. DETAILED DESCRIPTION
[0031] The following embodiments of the present invention are described in further detail in conjunction with the accompanying drawings and examples. The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention.
[0032] Example 1
[0033] The first step of the operation is to establish the puncture channel, which can be determined by cooperating with the existing stereotactic stent device. After skin preparation, incision, and drilling, a 5 mm diameter stent is placed in the center of the hematoma. Figure 2 , hold the guide wire 207 and the external interface 203 to pass the stent 201 through the cranial hole to the center of the hematoma.
[0034] After the stent is placed in the center of the hematoma, it expands and dilates. Figure 4 As shown, if the liquid hematoma infiltrates into the stent 401, the stent expands and adheres to press the solid blood clot toward the bleeding point to achieve initial hemostasis, and the water sprayed from the flushing tube enters the stent from the interface 403, and the flow drives the hematoma to flow out from the suction tube interface 402. Figure 3 As shown, the flushing liquid enters the flushing tube 304 and reaches the tube opening 302 at the head end of the flushing tube, flushes the blood that has infiltrated the expanded stent and reaches the suction tube 305 at the tail end.
[0035] The hematoma volume decreases and the stent expands further. Figure 8 As shown, in order to better remove the hematoma, a flexible flushing tube 802 can be used to flush the side wall of the stent 801. Further, a hematoma-melting solution containing urokinase or the like can be used to flush the solid blood clot, and the hematoma flows out from the suction tube 803.
[0036] After flushing, hemostatic materials can be injected. The hemostatic materials placed in the stent include but are not limited to powdered, gelatinous, liquid and solid hemostatic materials. The hemostatic materials are preferably liquid hemostatic materials that can coagulate after the high-frequency electrode outputs energy, such as various protein coagulants.
[0037] Insertion of a high-frequency balloon-type hemostatic device, such as Figure 7 As shown, the balloon 701 enters the stent 703 in a contracted state, and expands after reaching the stent. The high-frequency hemostatic electrode on the surface of the balloon causes the blood and hemostatic material that have seeped out of the stent to coagulate on the stent. The output frequency is 30 MHz, and the current output time and power are controlled so that the coagulation depth only reaches the stent layer, avoiding damage to the stent surface and deeper brain tissue.
[0038] After coagulation, select the balloon cooling cycle according to the situation, connect an external balloon-type intracranial pressure detector, stop bleeding and control intracranial pressure.
[0039] Example 2
[0040] During clinical treatment of cerebral hemorrhage, the location of the hematoma is determined preoperatively using imaging equipment combined with an intraoperative navigation surgical positioning system.
[0041] The first step of the operation is to establish the puncture channel, which can be determined by cooperating with the existing stereotactic stent device. After skin preparation, incision and drilling, a stent with a diameter of 0.1 mm is placed in the center of the hematoma. Figure 2, hold the guide wire 207 and the external interface 203 to pass the stent 201 through the cranial hole to the center of the hematoma.
[0042] After the stent is placed in the center of the hematoma, it expands and dilates. Figure 4 As shown, if the liquid hematoma infiltrates into the stent 401, the stent expands and adheres to press the solid blood clot toward the bleeding point to achieve initial hemostasis, and the water sprayed from the flushing tube enters the stent from the interface 403, and the flow drives the hematoma to flow out from the suction tube interface 402. Figure 3 As shown, the flushing liquid enters the flushing tube 304 and reaches the tube opening 302 at the head end of the flushing tube, flushes the blood that has infiltrated the expanded stent and reaches the suction tube 305 at the tail end.
[0043] The hematoma volume decreases and the stent expands further. Figure 8 As shown, in order to better remove the hematoma, a flexible flushing tube 802 can be used to flush the side wall of the stent 801. Further, a hematoma-melting solution containing urokinase or the like can be used to flush the solid blood clot, and the hematoma flows out from the suction tube 803.
[0044] After flushing, hemostatic materials can be injected. The hemostatic materials placed in the stent include but are not limited to powdered, gelatinous, liquid and solid hemostatic materials. The hemostatic materials are preferably liquid hemostatic materials that can coagulate after the high-frequency electrode outputs energy, such as various protein coagulants.
[0045] An arc-shaped convex head high-frequency hemostasis device is inserted. An electrode 602 is provided on the surface of the arc-shaped convex head 601. The arc-shaped convex head is connected to a multi-lumen tube 603 and a power cord 604. The output frequency is 30KHz. The current output time and power are controlled to electrocoagulate the side walls and penetrate through the gaps of the stent to electrocoagulate bleeding points deep inside the brain tissue.
[0046] The arc-shaped convex head high-frequency hemostatic device is removed, and implantable hemostatic powder or tissue engineering scaffold material can be injected into the stent to stop bleeding and combine with the stent as a long-term implant device to repair brain tissue damaged by bleeding.
Claims
1. A stent intra-stent suction hemostasis device for treating cerebral hemorrhage, characterized in that: The device comprises a support at the front end, a flushing catheter and a suction catheter connected to the support; the front end of the support is connected to the flushing tube, and the rear end is connected to the suction tube. The flushing water flows out from the flushing tube at the front end of the support, driving the blood that infiltrates from the side wall of the support to flow out from the suction tube at the rear end of the support.
2. The intra-stent suction hemostasis device for treating cerebral hemorrhage according to claim 1, characterized in that: The front end of the bracket is fixed on the arc-shaped smooth ball head, the ball head closes the front end of the bracket, the flushing tube is connected and fixed to the ball head rod, the flushing tube has a built-in guide wire for inserting the bracket into the hematoma center of cerebral hemorrhage during surgery, the flushing tube mouth is located inside the front end of the bracket, and the flushing and suction water flows inside the bracket to the suction tube at the rear end of the bracket, driving the hematoma that has infiltrated from the side wall of the bracket to flow out, and the flushing and suction pressure of the water flow is limited to the inside of the bracket to avoid acting on the brain tissue, forming an intra-stent flushing and suction flow.
3. The intra-stent suction hemostasis device for treating cerebral hemorrhage according to claim 1, characterized in that: An active high-frequency hemostatic device can be placed inside the bracket. The surface of the active high-frequency hemostatic device has metal electrodes. The hemostatic device is connected to a catheter. The catheter has a pipeline and a power line connected to the electrodes.
4. The intra-stent suction hemostasis device for treating cerebral hemorrhage according to claim 1, characterized in that: The stent is an expandable porous stent, and the diameter before expansion is not less than 0.1 mm, and more preferably 0.5 mm-2.5 mm.
5. The intra-stent suction hemostasis device for treating cerebral hemorrhage according to claim 3, characterized in that: The active high-frequency hemostasis device has a front end of a balloon, which covers a multi-lumen tube. The multi-lumen tube has inlet and outlet liquid pipelines inside the balloon, and the rear end of the multi-lumen tube is connected to the liquid inlet and outlet interface. The balloon surface electrode is connected to the active energy device through a power cord built into the multi-lumen tube. The cooling liquid enters the balloon through the multi-lumen tube to cool the balloon surface electrode and surrounding brain tissue.
6. The intra-stent suction hemostasis device for treating cerebral hemorrhage according to claim 3, characterized in that: The front end of the active high-frequency hemostasis device is a coagulation catheter with an arc-shaped convex head, the surface of the arc-shaped convex head is provided with electrodes, and the arc-shaped convex head is connected to a multi-lumen tube.
7. The intra-stent suction hemostasis device for treating cerebral hemorrhage according to claim 1, characterized in that: The flushing and suction tube can transport hemostatic materials to be inserted into the stent for hemostasis. The hemostatic materials inserted into the stent include but are not limited to powdered, gelatinous, liquid and solid hemostatic materials. The hemostatic materials are preferably liquid hemostatic materials that can coagulate after the high-frequency electrode outputs energy, such as various protein coagulants.
8. The intra-stent suction hemostasis device for treating cerebral hemorrhage according to claim 5, characterized in that: After the active high-frequency balloon hemostasis device is placed into the stent through the suction tube, cooling liquid is injected through the balloon multi-lumen tube to expand the balloon close to the stent. Between the brain tissue and the electrode, there is a stent, filled hemostatic material and exuded blood. The power supply is turned on to control the electrode to output energy so that the filled hemostatic material and exuded blood coagulate on the stent.
9. The intra-stent suction hemostasis device for treating cerebral hemorrhage according to claim 1, characterized in that: The active high-frequency hemostasis device electrode input frequency range is 3kHz-300MHz, and the preferred frequency range is the radiofrequency ablation band of 300kHz-30MHz.
10. The intra-stent suction hemostasis device for treating cerebral hemorrhage according to claim 1, characterized in that: The flushing tube is a bendable tube with a bending angle of 0° to 180°.