Internal fixation type blood vessel puncture plugging device

Abstract

The invention relates to an internal fixation type blood vessel puncture plugging device which comprises an internal fixation type patch, the internal fixation type patch comprises a plugging sheet, reinforcing ribs and supporting feet, the reinforcing ribs are evenly distributed on the lower surface of the plugging sheet, and the supporting feet are arranged at the two ends of the lower surface of the plugging sheet respectively. The intravascular fixed patch is made of a degradable shape memory material. Compared with an adhesion type patch, plugging is firmer, wrinkles formed on the blood vessel wall after suturing can be avoided, and the forming risk of thrombus and aneurysm is reduced; the intravascular fixed patch is used for blocking the inner wall of a blood vessel, and the effect is better; by adopting the degradable intravascular fixed patch, rejection reaction can be avoided; the intravascular fixed patch is suitable for blocking a large-diameter puncture opening of a vein or an artery.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to an internal fixation vascular puncture and occlusion device. Background Technology

[0002] Existing vascular occluders include two structural forms: suture and adhesion. Using suture-type occluders may cause wrinkling of the vessel wall after suturing, leading to adverse consequences such as thrombosis. Adhesion-type occluders have poor adhesion effects at large-diameter puncture sites and are easily broken by blood flow. Therefore, neither of these types of occluders can effectively suture and achieve good occlusion at large-diameter puncture sites. Furthermore, existing vascular occluders are not suitable for occluding both arterial and venous puncture sites. Therefore, improvements are urgently needed. Summary of the Invention

[0003] To address the aforementioned technical problems, this invention provides an internal fixation vascular puncture and occlusion device, comprising an internal fixation patch, wherein the internal fixation patch includes an occlusion sheet, reinforcing ribs, and support legs. The lower surface of the occlusion sheet is evenly distributed with a plurality of the reinforcing ribs and each end of the lower surface is provided with a support leg. The internal fixation patch is made of a biodegradable shape memory material.

[0004] Furthermore, the intravascular fixation patch adopts an intravascular polygonal fixation patch, which includes a first polygonal occlusion sheet, a first cross-shaped reinforcing rib, and a first annular support. The lower surface of the first polygonal occlusion sheet is evenly distributed with a plurality of the first cross-shaped reinforcing ribs, and each end of the lower surface is provided with a first annular support.

[0005] Furthermore, the intravascular polygonal fixation patch adopts an intravascular rectangular fixation patch, which includes a first rectangular occlusion sheet, a first cross-shaped reinforcing rib, and a first circular foot. The lower end face of the first rectangular occlusion sheet is provided with the first cross-shaped reinforcing rib, and each of the two wide ends of the lower end face is provided with a first circular foot.

[0006] Furthermore, the included angle between the two first annular support legs and the first rectangular sealing sheet is 110-130 degrees.

[0007] Furthermore, the first annular support leg is coated with anticoagulant and angiogenic repair drugs.

[0008] The aforementioned anticoagulant and angiogenesis-promoting drugs are substances that help reduce thrombus formation, promote vascular repair and growth.

[0009] The compression and folding method of the intravascular rectangular fixation patch is to fold along the midline of the wide side of the first rectangular occlusion sheet. After folding, the inner surfaces of the two first annular legs should be tightly attached to the bottom of the first rectangular occlusion sheet. This allows the outer surfaces of the two first annular legs to be unfolded and supported on the inner walls of the blood vessels on both sides of the puncture site first, along the direction of blood flow. At this time, the flowing blood can pass smoothly through the inner holes of the two first annular legs. While the two first annular legs complete the intravascular support and fixation, the upper surface of the first rectangular occlusion sheet also unfolds and fits tightly against the puncture site to form an intravascular wall fixation and occlusion effect.

[0010] Furthermore, it includes an extravascular patch, wherein the extravascular patch is an extravascular polygonal patch, the extravascular polygonal patch includes a second polygonal occlusion sheet, the second polygonal occlusion sheet has a first blood flow detection hole in the middle, and a detection probe of a blood flow detector is installed at the first blood flow detection hole, and the extravascular patch is made of a biodegradable shape memory material.

[0011] The blood flow detector is used to detect blood flow in real time after the puncture site is sealed. It can detect abnormal changes in blood flow in a timely manner when thrombi or aneurysms are formed after the operation, and remind doctors to intervene, thereby greatly reducing the risk of postoperative complications.

[0012] Furthermore, the extravascular polygonal patch is an extravascular rectangular patch, which includes a second rectangular occlusion sheet. The second rectangular occlusion sheet has a first infrared blood flow detection hole in the middle, and an optical probe of an infrared blood flow detector is installed at the first infrared blood flow detection hole.

[0013] The infrared blood flow detector is a medical device based on near-infrared spectroscopy technology. It can monitor blood flow and blood oxygen saturation in human tissues in real time through the blood vessel wall. Its core principle is to use near-infrared light to penetrate the blood vessel wall and selectively absorb it with oxyhemoglobin and deoxyhemoglobin in the blood. Then, the reflected light signal is received by a photodetector, and the changes in light intensity are analyzed to calculate the dynamic parameters of blood flow.

[0014] The rectangular patch outside the blood vessel is pushed, released, and unfolded by the pusher of the delivery device, and closely adheres to the outside of the blood vessel at the puncture site to achieve the effect of physical compression hemostasis.

[0015] Furthermore, the surface of the rectangular patch outside the blood vessel is coated with antibiotics. The antibiotics are used to combat infection.

[0016] Furthermore, the intravascular fixation patch adopts an intravascular conical fixation patch, which includes a first conical thin sheet, a second cross-shaped reinforcing rib, and a second annular support. The lower surface of the first conical thin sheet is evenly distributed with several second cross-shaped reinforcing ribs, and a second annular support is provided at each end of the lower end face.

[0017] Furthermore, the intravascular conic curve fixed patch adopts an intravascular elliptical fixed patch, which includes a first elliptical occlusion sheet, a second cross-shaped reinforcing rib, and a second annular support. The lower surface of the first elliptical occlusion sheet is provided with the second cross-shaped reinforcing rib, and a second annular support is provided at each end of the long axis of the lower surface.

[0018] Furthermore, the included angle between the two second annular support legs and the first elliptical sealing sheet is 110-130 degrees.

[0019] Furthermore, the second annular support is coated with anticoagulant and angiogenic repair agents.

[0020] The compression and folding method of the intravascular elliptical fixation patch is to fold along the midline of the long axis of the first elliptical occlusive film. After folding, the inner surfaces of the two second annular supports should be tightly attached to the bottom of the first elliptical occlusive film. This allows the outer surfaces of the two second annular supports to be unfolded and supported on the inner walls of the blood vessels on both sides of the puncture site first, along the direction of blood flow. At this time, the flowing blood can pass smoothly through the inner holes of the two second annular supports. While the two second annular supports complete the intravascular support and fixation, the upper surface of the first elliptical occlusive film also unfolds and tightly adheres to the puncture site to form an intravascular wall fixation and occlusion effect.

[0021] Furthermore, it includes an extravascular patch, wherein the extravascular patch is an extravascular conical patch, the extravascular conical patch includes a second conical thin sheet, a second blood flow detection hole is opened in the middle of the second conical thin sheet, and a detection probe of a blood flow detector is installed at the second blood flow detection hole.

[0022] Furthermore, the extravascular conic section patch is an extravascular elliptical patch, which includes a second elliptical occlusion sheet. The second elliptical occlusion sheet has a second infrared blood flow detection hole in the middle, and an optical probe of an infrared blood flow detector is installed at the second infrared blood flow detection hole.

[0023] The oval-shaped occlusion patch is pushed, released, and unfolded by the pusher of the delivery device, and closely adheres to the outside of the blood vessel at the puncture site to achieve physical compression hemostasis.

[0024] Furthermore, the device includes a delivery system comprising a sheath, a blood return indicator, a handle, and a push rod. The sheath is a thin-walled tubular structure. The front end of the internal cavity of the sheath is used to place the compressed and folded intravascular fixation patch or extravascular patch. The push rod is mounted at the rear end of the sheath. The handle is located at the rear end of the sheath. The blood return indicator is mounted on the sheath near the handle.

[0025] The blood return indicator is used to observe whether the tip of the sheath has entered the blood vessel. When blood flows out of the blood return indicator due to blood pressure, it indicates that the tip of the sheath has entered the blood vessel.

[0026] Furthermore, the surface of the extravascular oval patch is coated with antibiotics. These antibiotics are used to combat infection.

[0027] The working principle of this invention is explained below using intravascular rectangular fixed patches and extravascular rectangular patches as examples: Step 1: First, place the compressed intravascular rectangular fixed patch into the front end of the sheath of the delivery device. Then, insert the sheath into the vascular puncture site. When pulsating bleeding appears in the blood return vessel on the blood return monitor, stop pushing the sheath. Then, push the lever to push the compressed intravascular rectangular fixed patch out of the sheath to the inside of the vascular puncture site and release it. At this time, the compressed intravascular rectangular fixed patch gradually unfolds and restores its original shape through its shape memory function. The unfolding angle between the two first annular supports and the first rectangular sheet is 110-130 degrees. Then, the outer circular surfaces of the two first annular supports support the patch. Inside the vascular puncture site, on the inner walls of the blood vessels along the direction of blood flow, the flowing blood can pass smoothly through the inner circular holes of the two first annular supports. Therefore, the two first annular supports can both fix the rectangular fixation patch inside the blood vessel and not affect the normal flow of blood inside the blood vessel. At the same time as the two first annular supports complete the intravascular support and fixation, the upper surface of the first rectangular occlusion patch also unfolds and fits tightly against the puncture site to form an intravascular fixation and occlusion effect. Meanwhile, after the delivery device completes the release action, it can withdraw the sheath until the blood return display shows no bleeding from the return vessel.

[0028] Step 2: First, place the compressed rectangular patch outside the blood vessel into the front end of the sheath of the delivery device. Then, stop pushing the sheath when it is inserted into the outside of the puncture site. Subsequently, push the rod to push the compressed rectangular patch outside the blood vessel out of the sheath to the outside of the puncture site and release it. At this time, the compressed rectangular patch outside the blood vessel gradually unfolds and restores its original shape through its shape memory function and fits tightly against the outside of the puncture site to achieve the effect of external vascular occlusion. At the same time, the delivery device can be withdrawn after the release action is completed, and the entire bidirectional vascular puncture occlusion is completed.

[0029] Compared with the prior art, the beneficial effects of the present invention are as follows: 1. Compared with existing suture-type vascular occluders, the internal fixation vascular puncture occluder of the present invention can avoid the formation of folds in the vascular wall after suturing and reduce the risk of thrombosis and aneurysm formation; 2. Compared with existing adhesive vascular occluders, the internal fixation vascular puncture occluder of the present invention provides a more secure vascular fixation patch released at the puncture site compared with adhesive patches. 3. This invention uses an intravascular fixation patch and an extravascular patch to achieve bidirectional occlusion on the inner and outer walls of the blood vessel, resulting in a better occlusion effect; 4. The present invention, by using biodegradable materials to make intravascular and extravascular patches, can avoid rejection reactions caused by permanent implantation of foreign substances into the human body; 5. Since the endovascular fixation patch of the present invention does not require the thickness and elasticity of the vessel wall at the occlusion site, the present invention is suitable for occlusion of large-diameter puncture sites of veins or arteries. In contrast, existing vascular occluders have limited applications, either only for occlusion of arterial puncture sites or only for occlusion of venous puncture sites. Attached Figure Description

[0030] Figure 1 This is a three-dimensional view of a preferred embodiment of the intravascular fixation patch of the present invention: an intravascular rectangular fixation patch. Figure 2 for Figure 1 The front view of the rectangular fixed patch inside the blood vessel shown; Figure 3 for Figure 1 A top view of the rectangular fixed patch within the blood vessel shown. Figure 4 for Figure 1 The image shows a bottom view of an intravascular rectangular fixed patch. Figure 5 for Figure 1 A three-dimensional view of the compressed and folded rectangular fixed patch within the blood vessel. Figure 6 for Figure 5 The front view of the compressed and folded intravascular rectangular fixation patch shown. Figure 7 for Figure 5 A top view of the compressed and folded intravascular rectangular fixation patch shown. Figure 8 for Figure 5 The left view of the compressed and folded intravascular rectangular fixation patch shown. Figure 9 This is a three-dimensional view of a preferred embodiment of the extravascular patch of the present invention: an extravascular rectangular patch. Figure 10 for Figure 9 A three-dimensional image of the rectangular patch outside the blood vessel after compression and folding; Figure 11 for Figure 10 A front view of the rectangular patch outside the blood vessel shown; Figure 12 for Figure 10 Top view of the rectangular patch outside the blood vessel shown; Figure 13 for Figure 10 Left view of the rectangular patch outside the blood vessel shown; Figure 14 This is a perspective view of a preferred embodiment of the conveyor of the present invention; Figure 15 for Figure 14 The image shown depicts a three-dimensional view of a delivery device pushing a compressed and folded rectangular fixed patch within a blood vessel towards the vascular puncture site via a pusher rod inside the sheath. Figure 16 for Figure 14 The image shown is a three-dimensional view of a rectangular patch outside the blood vessel, equipped with a blood flow detector, being pushed and compressed by a pusher inside the sheath, near the vascular puncture site. Figure 17 This is a perspective view of a preferred embodiment of the intravascular fixation patch of the present invention: an elliptical intravascular fixation patch. Figure 18 for Figure 17 The front view of the oval-shaped fixed patch inside the blood vessel shown. Figure 19 for Figure 17 A top view of the oval-shaped fixed patch inside the blood vessel shown. Figure 20 for Figure 17 A bottom view of the oval-shaped fixed patch inside the blood vessel shown. Figure 21 This is a perspective view of a preferred embodiment of the extravascular patch of the present invention, namely an extravascular elliptical patch; Figure 22This is a schematic diagram illustrating the bidirectional occlusion state formed between the inner and outer walls of the blood vessel at the puncture site by an intravascular rectangular fixed patch, an extravascular rectangular patch, or an intravascular elliptical fixed patch and an extravascular elliptical patch, which are preferred embodiments of the present invention.

[0031] Figure label: 1-Intravascular rectangular fixation patch; 1.1-First rectangular occlusion patch; 1.2-First cross-shaped reinforcing rib; 1.3-First circular support leg; 2-Extravascular rectangular patch; 2.1-Second rectangular occlusion patch; 2.2-First infrared blood flow detection port; 3-Conveyor; 3.1-Sheath; 3.2-Blood return indicator; 3.3-Handle; 3.4-Push rod; 4-Intravascular elliptical fixation patch; 4.1-First elliptical occlusion patch; 4.2-Second cross-shaped reinforcing rib; 4.3-Second circular support leg; 5-Extravascular elliptical patch; 5.1-Second elliptical occlusion patch; 5.2-Second infrared blood flow detection port; 6-Infrared blood flow detector; 7-Vascular vessel; 7.1-Puncture port; 7.2-Inner wall of the vascular vessel. Detailed Implementation

[0032] The preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0033] To address the aforementioned problems in the prior art, this invention provides an internal fixation vascular puncture and occlusion device, see [link to previous invention]. Figures 1-22 The vascular fixation patch includes an endovascular fixation patch comprising an occlusion sheet, reinforcing ribs, and support legs. The occlusion sheet has several reinforcing ribs evenly distributed on its lower surface and a support leg at each end of its lower surface. The endovascular fixation patch is made of a biodegradable shape memory material.

[0034] Optionally, see Figures 1-14 The intravascular fixation patch is an intravascular polygonal fixation patch, which includes a first polygonal occlusion sheet, a first reinforcing rib, and a first foot. The lower surface of the first polygonal occlusion sheet is evenly distributed with several first cross-shaped reinforcing ribs, and each end of the lower surface is provided with a first annular foot 1.3.

[0035] Optionally, such as Figures 1-8 As shown, the intravascular polygonal fixation patch adopts an intravascular rectangular fixation patch 1. The intravascular rectangular fixation patch 1 includes a first rectangular occlusion sheet 1.1, a first cross-shaped reinforcing rib 1.2, and a first circular foot 1.3. The lower surface of the first rectangular occlusion sheet 1.1 is provided with the first cross-shaped reinforcing rib 1.2, and each of the two wide sides of the lower surface is provided with a first circular foot 1.3.

[0036] Optionally, such as Figure 1 and Figure 2 As shown, the included angle between the two first annular support legs 1.3 and the first rectangular sealing sheet 1.1 is 110-130 degrees.

[0037] Optionally, the first annular support 1.3 is coated with an anticoagulant and a vascular repair agent.

[0038] The aforementioned anticoagulant and angiogenesis-promoting drugs are substances that help reduce thrombus formation, promote vascular repair and growth.

[0039] like Figures 1-8 , Figure 14 , Figure 15 As shown, the compression and folding method of the intravascular rectangular fixation patch 1 is to fold along the midline of the wide side of the first rectangular occlusion sheet 1.1. After folding, the inner surfaces of the two first annular supports 1.3 should be tightly attached to the lower part of the first rectangular occlusion sheet 1.1, so that when the push rod 3.4 of the delivery device 3 releases the intravascular rectangular fixation patch 1, the outer circular surfaces of the two first annular supports 1.3 can first support the inner walls 7.2 of the blood vessels on both sides of the puncture port 5.1 along the direction of blood flow. At this time, the flowing blood can pass smoothly through the inner circular holes of the two first annular supports 1.3. At the same time as the two first annular supports 1.3 complete the intravascular support and fixation, the upper surface of the first rectangular occlusion sheet 1.1 also unfolds and tightly adheres to the puncture port 5.1 to form a fixation and occlusion effect on the inner walls 7.2 of the blood vessels.

[0040] Optionally, see Figures 9-13 The device includes an extravascular patch, wherein the extravascular patch is a polygonal patch, the extravascular patch includes a second polygonal occlusion sheet, the second polygonal occlusion sheet has a first blood flow detection hole in the middle, and a detection probe of a blood flow detector is installed at the first blood flow detection hole. The extravascular patch is made of a biodegradable shape memory material.

[0041] The blood flow detector is used to detect blood flow in real time after the puncture site is sealed. It can detect abnormal changes in blood flow in a timely manner when thrombi or aneurysms are formed after the operation, and remind doctors to intervene, thereby greatly reducing the risk of postoperative complications.

[0042] Optionally, such as Figures 9-13 As shown, the extravascular polygonal patch adopts an extravascular rectangular patch 2, which includes a second rectangular occlusion sheet. The second rectangular occlusion sheet has a first infrared blood flow detection hole 2.1 in the middle, and an optical probe of an infrared blood flow detector 6 is installed at the first infrared blood flow detection hole 2.1.

[0043] The infrared blood flow detector 6 is a medical device based on near-infrared spectroscopy technology. It can monitor blood flow and blood oxygen saturation in human tissues in real time through the blood vessel wall. Its core principle is to use near-infrared light to penetrate the blood vessel wall and selectively absorb it with oxyhemoglobin and deoxyhemoglobin in the blood. Then, the reflected light signal is received by a photoelectric detector, and the changes in light intensity are analyzed to calculate the dynamic parameters of blood flow.

[0044] like Figure 16 As shown, the rectangular patch 2 outside the blood vessel is pushed, released, unfolded, and closely attached to the outside of the blood vessel 7 at the puncture site 7.1 by the push rod 3.4 of the delivery device 3, thereby achieving the effect of physical compression hemostasis.

[0045] Furthermore, the surface of the rectangular patch 2 outside the blood vessel is coated with antibiotics to fight infection.

[0046] Optionally, see Figures 17-20 The intravascular fixation patch adopts an intravascular conical curve fixation patch, which includes a first conical curve thin sheet, a second cross-shaped reinforcing rib, and a second annular support 4.3. The lower surface of the first conical curve thin sheet is evenly distributed with several second cross-shaped reinforcing ribs, and a second annular support 4.3 is provided at each end of the lower surface.

[0047] Optionally, such as Figures 17-20 As shown, the intravascular conic curve fixed patch adopts an intravascular elliptical fixed patch 4. The intravascular elliptical fixed patch 4 includes a first elliptical occlusion sheet 4.1, a second cross-shaped reinforcing rib 4.2, and a second circular foot 4.3. The lower surface of the first elliptical occlusion sheet 4.1 is provided with the second cross-shaped reinforcing rib 4.2, and a second circular foot 4.3 is provided at each end of the long axis of the lower surface.

[0048] Optionally, such as Figure 17 and Figure 18 As shown, the included angle between the two second annular support legs 4.3 and the first elliptical sealing sheet 4.1 is 110-130 degrees.

[0049] Optionally, the second annular foot 4.3 is coated with an anticoagulant and a vascular repair agent.

[0050] See Figures 17-20 , Figure 15The compression and folding method of the intravascular elliptical fixation patch 4 is to fold along the midline of the long axis of the first elliptical occlusive film 4.1. After folding, the inner surfaces of the two second annular supports 4.3 should be tightly attached to the lower part of the first elliptical occlusive film 4.1, so that when the push rod 3.4 of the delivery device 3 releases the intravascular elliptical fixation patch 4, the outer circular surfaces of the two second annular supports 4.3 can first support the inner walls 7.2 of the blood vessels on both sides of the puncture port 7.1 along the direction of blood flow. At this time, the flowing blood can pass smoothly through the inner circular holes of the two second annular supports 4.3. At the same time as the two second annular supports 4.3 complete the intravascular support and fixation, the upper surface of the first elliptical occlusive film 4.1 also unfolds and tightly adheres to the puncture port 7.1 to form an intravascular fixation and occlusion effect.

[0051] Optionally, see Figure 21 The device includes an extravascular patch, wherein the extravascular patch is an extravascular conical patch, the extravascular conical patch includes a second conical thin sheet, a second blood flow detection hole is opened in the middle of the second conical thin sheet, and a detection probe of a blood flow detector is installed at the second blood flow detection hole.

[0052] Optionally, such as Figure 21 As shown, the extravascular conic section patch adopts an extravascular elliptical patch 5, which includes a second elliptical occlusion sheet 5.1. The second elliptical occlusion sheet 5.1 has a second infrared blood flow detection hole 5.2 in the middle, and the optical probe of the infrared blood flow detector 6 is installed at the second infrared blood flow detection hole 5.2.

[0053] See Figure 16 The elliptical occlusion patch 5 is pushed, released, unfolded, and closely adhered to the outside of the blood vessel 7 at the puncture site 7.1 by the push rod 3.4 of the delivery device 3, thereby achieving the effect of physical compression hemostasis.

[0054] Optionally, the surface of the extravascular oval patch 5 is coated with an antibiotic. The antibiotic is used to fight infection.

[0055] Optionally, such as Figure 14 As shown, the device includes a delivery device 3, which comprises a sheath 3.1, a blood return indicator 3.2, a handle 3.3, and a push rod 3.4. The sheath 3.1 has a thin-walled tubular structure. The front end of the internal cavity of the sheath 3.1 is used to place the compressed and folded intravascular fixation patch or extravascular patch, and the push rod 3.4 is installed at the rear end. The handle 3.3 is located at the rear end of the sheath 3.1, and the blood return indicator 3.2 is mounted on the sheath 3.1 near the handle 3.3.

[0056] The working principle of this invention is explained below using intravascular rectangular fixed patch 1 and extravascular rectangular patch 2 as examples: Step 1: As Figure 15 , Figure 22 As shown, the compressed intravascular rectangular fixed patch 1 is first placed into the front end of the sheath 3.1 of the delivery device 3, and then the sheath 3.1 is inserted into the puncture site 5.1 of the blood vessel 5. When pulsating bleeding occurs in the blood return vessel on the blood return indicator 3.2, the pushing of the sheath 3.1 is stopped. Then, the push rod 3.4 pushes the compressed intravascular rectangular fixed patch 1 out from the sheath 3.1 to the inside of the puncture site 5.1 of the blood vessel 5 and releases it. At this time, the compressed intravascular rectangular fixed patch 1 gradually unfolds and restores its original shape through its own shape memory function. The unfolding angle between the two first annular support legs 1.3 and the first rectangular occlusion sheet 1.1 is 110-130 degrees, and then the outer circular surface of the two first annular support legs 1.3... The first circular support 1.3 is supported on the inner wall 5.2 of the blood vessel 5 along the direction of blood flow inside the puncture site 5.1. Since the blood flowing in the blood vessel can pass smoothly through the inner circular holes of the two first circular support 1.3, the two first circular support 1.3 can not only fix the rectangular fixed patch 1 inside the blood vessel, but also not affect the normal flow of blood in the blood vessel. At the same time as the two first circular support 1.3 complete the support and fixation inside the blood vessel, the upper surface of the first rectangular occlusion patch 1.1 also unfolds and fits tightly against the puncture site 5.1 to form an internal fixation and occlusion effect. At the same time, after the delivery device 3 completes the release action, it can withdraw the sheath 3.1 until the blood return display 3.2 stops bleeding.

[0057] Step 2: As Figure 16 , Figure 22 As shown, the compressed rectangular patch 2 is first placed into the front end of the sheath 3.1 of the delivery device 3. Then, when the sheath 3.1 is inserted into the outside of the puncture site 5.1 of the blood vessel 5, the pushing of the sheath 3.1 is stopped. Then, the push rod 3.4 pushes the compressed rectangular patch 2 out of the sheath 3.1 to the outside of the puncture site 5.1 of the blood vessel 5 and releases it. At this time, the compressed rectangular patch 2 gradually unfolds and restores its original shape through its own shape memory function and fits tightly against the outside of the puncture site 5.1 to achieve the effect of external vascular occlusion. At the same time, the delivery device 3 can withdraw the sheath 3.1 after completing the release action, and the bidirectional occlusion of the entire puncture of the blood vessel 5 is completed.

[0058] This invention avoids the formation of folds in the vessel wall after suturing and reduces the risk of thrombosis and aneurysm formation. The endovascular fixation patch released at the puncture site 7.1 provides a more secure seal compared to adhesive patches. This invention achieves bidirectional occlusion on the inner and outer walls of the vessel through the endovascular fixation patch and the extravascular patch, respectively, resulting in better occlusion. The use of biodegradable materials in the endovascular and extravascular patches avoids rejection reactions caused by permanent implantation of foreign substances. Because the endovascular fixation patch of this invention has no requirements on the thickness and elasticity of the vessel wall at the occlusion site, it is suitable for occlusion of large-diameter puncture sites in veins or arteries. In contrast, existing vascular occluders have limited applications, either only for arterial puncture site occlusion or only for venous puncture site occlusion.

Claims

1. An internal fixation vascular puncture and occlusion device, characterized in that, The device includes an intravascular fixation patch, which comprises an occlusion sheet, reinforcing ribs, and feet. The occlusion sheet has several reinforcing ribs evenly distributed on its lower surface and a foot at each end of its lower surface. The intravascular fixation patch is made of a biodegradable shape memory material.

2. The internal fixation vascular puncture and occlusion device according to claim 1, characterized in that, The intravascular fixation patch is an intravascular polygonal fixation patch, which includes a first polygonal occlusion sheet, a first cross-shaped reinforcing rib, and a first annular support (1.3). The lower surface of the first polygonal occlusion sheet is evenly distributed with several first cross-shaped reinforcing ribs and each end of the lower surface is provided with a first annular support (1.3).

3. The internal fixation vascular puncture and occlusion device according to claim 2, characterized in that, The intravascular polygonal fixation patch adopts an intravascular rectangular fixation patch (1). The intravascular rectangular fixation patch (1) includes a first rectangular occlusion sheet (1.1), a first cross-shaped reinforcing rib (1.2), and a first circular foot (1.3). The first rectangular occlusion sheet (1.1) has the first cross-shaped reinforcing rib (1.2) on its lower surface and a first circular foot (1.3) on each of the two wide sides of its lower surface.

4. The internal fixation vascular puncture and occlusion device according to claim 1, characterized in that, The device includes an extravascular patch, which is a polygonal patch. The polygonal patch includes a second polygonal occlusion sheet. A first blood flow detection hole is opened in the middle of the second polygonal occlusion sheet. A detection probe of a blood flow detector is installed at the first blood flow detection hole. The extravascular patch is made of a biodegradable shape memory material.

5. The internal fixation vascular puncture and occlusion device according to claim 4, characterized in that, The extravascular polygonal patch adopts an extravascular rectangular patch (2), which includes a second rectangular occlusion sheet (2.1). The second rectangular occlusion sheet (2.1) has a first infrared blood flow detection hole (2.2) in the middle, and the optical probe of the infrared blood flow detector (6) is installed at the first infrared blood flow detection hole (2.2).

6. The internal fixation vascular puncture and occlusion device according to claim 1, characterized in that, The intravascular fixation patch adopts an intravascular conical fixation patch, which includes a first conical sheet, a second cross-shaped reinforcing rib, and a second annular support (4.3). The lower surface of the first conical sheet is evenly distributed with several second cross-shaped reinforcing ribs, and a second annular support (4.3) is provided at each end of the lower surface.

7. The internal fixation vascular puncture and occlusion device according to claim 6, characterized in that, The intravascular conical fixed patch adopts an intravascular elliptical fixed patch (4). The intravascular elliptical fixed patch (4) includes a first elliptical occlusion sheet (4.1), a second cross-shaped reinforcing rib (4.2), and a second circular foot (4.3). The lower surface of the first elliptical occlusion sheet (4.1) is provided with the second cross-shaped reinforcing rib (4.2), and a second circular foot (4.3) is provided at each end of the long axis of the lower surface.

8. The internal fixation vascular puncture and occlusion device according to claim 1, characterized in that, The device includes an extravascular patch, wherein the extravascular patch is an extravascular conical patch, the extravascular conical patch includes a second conical thin sheet, a second blood flow detection hole is opened in the middle of the second conical thin sheet, and a detection probe of a blood flow detector is installed at the second blood flow detection hole.

9. The internal fixation vascular puncture and occlusion device according to claim 8, characterized in that, The extravascular conic section patch adopts an extravascular elliptical patch (5), which includes a second elliptical occlusion sheet (5.1). The second elliptical occlusion sheet (5.1) has a second infrared blood flow detection hole (5.2) in the middle, and the optical probe of the infrared blood flow detector (6) is installed at the second infrared blood flow detection hole (5.2).

10. The internal fixation vascular puncture and occlusion device according to any one of claims 1-9, characterized in that, The device includes a delivery device (3), which includes a sheath (3.1), a blood return indicator (3.2), a handle (3.3), and a push rod (3.4). The sheath (3.1) has a thin-walled tubular structure. The front end of the internal cavity of the sheath (3.1) is used to place the compressed and folded intravascular fixation patch or extravascular patch. The push rod (3.4) is installed at the rear end. The handle (3.3) is located at the rear end of the sheath (3.1). The blood return indicator (3.2) is installed on the sheath (3.1) near the handle (3.3).

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