Novel aorta proximal anastomosis system for coronary artery bypass grafting

Abstract

The utility model discloses a novel aorta proximal anastomosis system for coronary artery bypass grafting, and belongs to the technical field of equipment for vascular anastomosis. The utility model solves the problems that the existing clinically used anastomosis system cannot be tightly attached to the inner wall of the aorta in practical application, and the anastomotic stoma continuously leaks blood along with cardiac pulsation, so that the definition of the surgical field of the anastomotic stoma is influenced, and the anastomosis effect is influenced. The device comprises a fixed tube, a filter, a plugging bag system and a feeding rod, the feeding rod is sleeved in the fixed tube, the filter is arranged in the fixed tube in a sliding manner, the feeding rod is in contact with the filter, and the plugging bag system is connected to the end part of the feeding rod. According to the aorta near-end anastomosis system, the blocking bag system has the better blocking capacity on local aorta blood leakage of an anastomotic stoma, the surgical field definition is improved, and the anastomosis quality is guaranteed.

Description

Technical Field

[0001] The utility model belongs to the technical field of equipment for vascular anastomosis, and particularly relates to a novel proximal aortic anastomosis system for coronary artery bypass grafting. Background Art

[0002] Currently, with the continuous deepening of population aging and the increasing prevalence of lifestyle diseases such as diabetes, hyperlipidemia, and hypertension, the proportion of patients with coronary heart disease who need coronary artery bypass grafting and have ascending aortic atherosclerosis is also increasing. Previous studies have shown that in patients undergoing coronary artery bypass grafting with classic cardiopulmonary bypass assistance, due to the hazards of operations such as aortic cannulation, cold perfusion, and ascending aortic cross-clamping, the incidence of stroke in patients after surgery is as high as 1% - 8%. If combined with severe aortic atherosclerosis, the incidence of stroke can be as high as 14.3%. This seriously affects the survival rate and quality of life of patients after surgery. Coronary artery bypass grafting without cardiopulmonary bypass avoids cardiopulmonary bypass and greatly reduces brain damage caused by cerebral air embolism and insufficient perfusion. However, its neurological complications are still as high as 1.1%.

[0003] Currently, the academic community has fully recognized that avoiding the shedding of ascending aortic plaques caused by clamping the aorta during CABG is the most effective means to reduce the occurrence of stroke during the perioperative period of CABG, and it is also the most effective way to eliminate mechanical damage to the aortic wall and avoid the occurrence of this catastrophic complication of iatrogenic aortic dissection. For OPCAB patients with poor cardiac function reserve and unstable intraoperative hemodynamics, avoiding clamping the ascending aorta is also an effective means to prevent intraoperative malignant arrhythmias and even cardiac arrest.

[0004] To avoid clamping the ascending aorta during CABG, two treatment strategies have been derived clinically. The "no-touch" strategy refers to directly anastomosing pedicled grafts such as the left and right internal mammary arteries and / or the right gastroepiploic artery to the target diseased blood vessels to avoid the operation of clamping the aorta. However, due to the limited number and length of arterial grafts, the all-arterial "no-touch" technique cannot be routinely implemented. The "no-clamp" strategy refers to using a special proximal assisted anastomosis device to complete the anastomosis between the proximal end of the graft and the ascending aorta. With the assistance of a special device, the graft can be anastomosed to it without clamping the ascending aorta. This method has no special requirements for the length, type, etc. of the graft, so it has become a more common way to deal with such problems clinically.

[0005] At present, the proximal auxiliary anastomosis devices widely used in clinical practice include the Enclose II anastomosis system launched by Novare and the Heartstring system produced by Guident. Compared with conventional side wall clamps, the use of the Enclose II system or the Heartstring system can significantly reduce the number of fixed microemboli during surgery and perioperative neurological complications. However, in actual use, the design of the above two auxiliary devices also has certain drawbacks; the Enclose II system is to puncture the ascending aorta wall with a purse string and insert the Encolse device, then open the distal diamond-shaped film in the aortic cavity to make it close to the inner wall of the aorta, and then cut the aorta above the film, make a hole, and anastomose. The Heartstring system directly makes a hole in the ascending aorta and inserts a ring-shaped coiled sealing umbrella, and then anastomoses the graft vessel at the hole in the raw aorta isolated by the sealing umbrella. The common problem of both is that if there are atherosclerotic plaques in the aortic intima around the anastomosis, the intraluminal isolation devices of the above two devices cannot fit tightly with the inner wall of the aorta, and the anastomosis will continue to leak blood with the heart beat, seriously affecting the clarity of the already limited anastomotic field, often leading to problems such as suture, uneven needle distance, anastomotic stenosis, and twisting. In severe cases, it may even affect the long-term patency of the graft.

[0006] Therefore, the present application proposes a novel proximal aortic anastomosis system for coronary artery bypass grafting to solve the above problems. Utility Model Content

[0007] The purpose of developing the utility model is to solve the problem that the anastomosis system currently used in clinical practice cannot fit tightly with the inner wall of the aorta in actual applications, and the anastomosis will continue to leak blood with the heart beat, affecting the clarity of the anastomotic field and the anastomotic effect. A brief overview of the utility model is given below to provide a basic understanding of certain aspects of the utility model. It should be understood that this overview is not an exhaustive overview of the utility model. It is not intended to determine the key or important parts of the utility model, nor is it intended to limit the scope of the utility model.

[0008] The technical solution of this utility model:

[0009] A novel proximal aortic anastomosis system for coronary artery bypass grafting comprises a fixing tube, a filter, a sealing bag system and a delivery rod. The delivery rod is sleeved in the fixing tube, the filter is slidably arranged in the fixing tube, the delivery rod is in contact with the filter, and the end of the delivery rod is connected to the sealing bag system.

[0010] Furthermore, the filter is connected to a connection point on the side wall of the fixed tube via a traction line.

[0011] Further, the fixed tube is a hollow cylinder with a length of 100 mm, a diameter of 5 mm, and an inner diameter of 4 mm.

[0012] Further, the plugging capsule system is a water bag, and a water inlet pipe is arranged on the plugging capsule system. The water inlet pipe runs through the feeding rod and is connected to a syringe for water injection.

[0013] Further, a needle track is machined at the tail end of the fixed tube.

[0014] Further, a rubber sheet is connected to the tail end of the fixed tube.

[0015] The utility model has the following beneficial effects:

[0016] 1. For the novel aortic proximal anastomosis system for coronary artery bypass grafting of the utility model, the plugging capsule system has a better blocking ability for local aortic blood leakage at the anastomosis site, improves the clarity of the surgical field, ensures the anastomosis quality, causes less damage to the local aortic intima by the plugging capsule system, avoids the shedding of local plaques during blocking, and can also reduce the hyperplasia of the aortic intima near the anastomosis site, thereby prolonging the long-term patency rate of the bypass vessel.

[0017] 2. For the novel aortic proximal anastomosis system for coronary artery bypass grafting of the utility model, the insertion of the fixed tube physically blocks the possibility of anastomosis mistakes such as "threading the wire" and "continuous crotch" during anastomosis, and the needle track designed at the end of the fixed tube provides a stable support surface for proximal anastomosis, ensures the uniformity of suture, reduces the difficulty of vascular anastomosis, and improves the accuracy and safety of anastomosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 is a schematic diagram of a novel aortic proximal anastomosis system for coronary artery bypass grafting;

[0019] Figure 2 is a schematic diagram of the cooperation relationship between the filter and the fixed tube;

[0020] Figure 3 is a schematic diagram of the filter contracted in the fixed tube;

[0021] Figure 4 is a schematic diagram of the fixed tube;

[0022] Figure 5 is a schematic diagram of the filter;

[0023] Figure 6 is a schematic diagram of the cooperation relationship between the fixed tube and the rubber sheet;

[0024] Figure 7 is a schematic diagram of the operation steps of a novel aortic proximal anastomosis system for coronary artery bypass grafting;

[0025] Figure 8 It is a schematic diagram of the operation steps in bypass surgery using the Heartstring system;

[0026] Figure 9 It is a schematic diagram of the operation steps using the Enclose system.

[0027] In the figure: 1 - fixing tube, 2 - filter, 3 - occlusion balloon system, 4 - feeding rod, 5 - traction wire, 6 - connection point, 7 - needle track, 8 - rubber sheet. Specific embodiments

[0028] To make the objectives, technical solutions and advantages of the present utility model clearer and more understandable, the present utility model will be described below through specific embodiments shown in the drawings. However, it should be understood that these descriptions are only exemplary and do not limit the scope of the present utility model. In addition, in the following description, descriptions of well-known structures and technologies are omitted to avoid unnecessarily confusing the concepts of the present utility model.

[0029] The connections mentioned in the present utility model are divided into fixed connections and detachable connections. The fixed connections (i.e., non-detachable connections) include, but are not limited to, conventional fixed connection methods such as hemming connections, rivet connections, bonding connections, and welding connections. The detachable connections include, but are not limited to, conventional disassembly methods such as screw connections, snap connections, pin connections, and hinge connections. When the specific connection method is not clearly defined, it is defaulted that at least one connection method can always be found among the existing connection methods to achieve this function, and those skilled in the art can select it according to their needs. For example: welding connection is selected for the fixed connection, and hinge connection is selected for the detachable connection.

[0030] Example 1, in combination with Figures 1 - 5 This example is described. A novel proximal aortic anastomosis system for coronary artery bypass grafting in this example includes a fixing tube 1, a filter 2, an occlusion balloon system 3, and a feeding rod 4. The feeding rod 4 is sleeved inside the fixing tube 1, the filter 2 is slidably arranged inside the fixing tube 1, the feeding rod 4 is in contact with the filter 2, and the end of the feeding rod 4 is connected with the occlusion balloon system 3.

[0031] The fixed tube 1 is 100 mm long, 5 mm in diameter, and 4 mm in inner diameter. The fixed tube 1 is a hollow cylinder. On the outer wall of the fixed tube 1, there are two connection points 6 at two symmetrical points at the midpoint height. Each connection point 6 is a prismatic protrusion, which is used to fix the traction line 5 of the filter 2. The lower edge of the fixed tube 1 is processed with an equidistant needle track 7. The needle track 7 is an equidistantly arranged groove arranged on the fixed tube 1 to assist the insertion of the 6-0 vascular anastomosis needle. The tail end of the needle track 7 continues to be a rubber sheet 8 perpendicular to the direction of the fixed tube 1. The rubber sheet 8 is not completely perpendicular to the fixed tube 1, and should form an arc outward, so that after the fixed tube 1 is placed in the aorta, the rubber sheet 8 can form a cavity with the aorta to prevent the suture from accidentally puncturing the occlusion bag system 3. The rubber sheet 8 fits with the aortic wall to form a suction cup, which increases the friction to fix the device and tightly close the device to the blood vessel wall.

[0032] The filter 2 is divided into a pre-release state and a release state. The pre-release state is as shown in the attached Figure 3 As shown, the filter 2 is a shuttle shape, 120 mm long and 3.5 mm in diameter. One suture is made at each of the four equal parts of the filter 2 for fixing the filter 2 after it is inserted. The filter 2 is pushed in by the insertion rod 4. After the filter 2 is placed in the aorta, it is slowly pushed out. The filter 2 is made of memory metal material. After being pushed out of the fixing tube 1, the filter 2 can automatically pop open. Figure 2 As shown, the filter 2 is buckled on the aorta wall in an arc shape. At this time, the four traction lines 5 previously sutured on the filter 2 are tightened, and the traction box 5 is pulled outward and wrapped around the two connection points 6 of the fixing tube 1 to fix the filter 2. The diameter of the filter 2 after release is 200 mm, and the outer wall of the filter 2 is similar to the curvature of the aorta to reduce blood flow resistance;

[0033] The occluding bag system 3 is a circle of water bags at the lower end of the delivery rod 4. The water bag water inlet tube runs inside the delivery rod 4, and the outer port is connected to a syringe for water injection. The diameter of the occluding bag system is about 190 mm after it is inflated. Microvilli-like bag wall protrusions are designed at the contact point between the water bag and the blood vessel wall to increase the friction between the two so that the device and the aorta are more tightly and stably combined, which can isolate the anastomosis from the aortic blood flow to the greatest extent, thereby reducing bleeding and ensuring the clarity of the surgical field.

[0034] During use, find a suitable position on the aortic wall, strip the local adventitia and then make a small incision on the blood vessel wall. Subsequently, insert the fixing tube 1 into the aorta to a depth of about 1 cm. Suture the filter 2 at its quarter positions with a single needle, leaving enough tail threads. Stretch the filter 2 and slowly insert it into the aorta with the feeding rod 4. After it is completely inserted into the aorta, tighten the traction wire 5 and wind it around the connection point 6 on the outer wall of the fixing tube 1. Inject an appropriate amount of water through the water inlet of the feeding rod 4 to inflate the occlusion balloon system 3. Take the bypass vessel, insert the needle from the outside to the inside, and then from the inside to the outside through the aortic wall. After the needle enters the aortic wall, it passes through the needle track 7 on the outer wall of the metal rod. Each track corresponds to one needle. After all sutures are completed, release the occlusion balloon system 3. Slightly stabilize and tighten the four traction wires 5 while pushing the feeding rod in the opposite direction and maintain a certain tension. First, remove the fixing tube 1 to the aortic adventitia, then slowly remove the filter 2 and the occlusion balloon system 3. Finally, tighten the traction wire 5 and tie a knot to complete the anastomosis.

[0035] During current clinical surgeries, the Heartstring system or the Enclose system is often used as the common proximal anastomosis system. As shown in the attached instructions Figure 6 The specific steps of using the Heartstring system are as follows: First, select a position. The operator determines the anastomosis position by routine examination and selects a healthy or the softest part on the anterior wall of the ascending aorta. The diameter of the anastomosis area is about 1 cm. Subsequently, perform pre-treatment before use. Immerse the sealing plug of the Heartstring in warm saline at 50 °C for 5 minutes to make its sealing performance and stability reach the best state, making it easier to insert. Then, use the attached puncher to pre-punch at the positioning site and insert the pre-treated and folded Heartstring into the aorta. Use 6-0 prolene suture to perform end-to-side anastomosis between the great saphenous vein and the aorta. For local bleeding, use a blower or a suction device to remove it. At the same time, ask the anesthesiologist to maintain the circulatory blood pressure at the lowest effective level to reduce bleeding. Finally, after all anastomoses are completed, fix the tip wire, withdraw the Heartstring, exhaust the air and tie a knot.

[0036] As a commonly used aortic proximal anastomosis device in cardiac surgery, the Heartstring cannot completely block the local aortic blood flow, resulting in an unclear surgical field. The operator needs the assistance of an assistant to blow or inject water to obtain a clear view. Moreover, this device does not provide a blood filtration device and cannot prevent the adverse consequences caused by accidentally detached plaques. The Heartstring cannot directly support the bypass vessel and has no auxiliary anastomosis function. As a disposable consumable, it can only be used for single punching and cannot be reused even in the same surgery, increasing the medical burden on patients.

[0037] The Enclose system is another commonly used proximal anastomosis system. As shown in the attached Figure 7As shown in the figure, during use, first gently press the ascending aorta with your finger to check for atherosclerotic plaques on the arterial wall, select a suitable puncture and placement point for the anastomosis device and the position of the anastomosis opening, make a purse-string suture at the puncture point, after puncturing and placing the Enclose proximal aortic anastomosis device, tighten the cannula to limit bleeding, open the diamond-shaped membrane at the selected anastomosis opening, and tighten the upper and lower arms to cut off the aortic blood flow. Incise, punch holes, and anastomose at the selected aortic anastomosis site. If multiple proximal anastomosis sites are required, there is no need for repeated puncture. Just find another atherosclerotic-free area of the ascending aorta and repeat the above operations.

[0038] The Enclose device requires two punctures of the aorta. Both puncture points need to be selected in healthy tissue areas, and the area between the two points should also be as healthy as possible, with relatively high requirements for the aorta. During the operation, the patient's blood pressure needs to be strictly controlled. When the blood pressure rises, it may lead to the formation of aneurysms. At the same time, on the premise of ensuring a blood-free environment in the operation area, the knob should be tightened appropriately to reduce excessive compression on the aortic wall. During the operation process, the arterial wall should be incised as perpendicular to the connecting rod direction as possible to avoid damaging the diaphragm. During the suture process, it should be noted that the suture should be from the inside out to avoid rupture of the anastomosis device diaphragm caused by incorrect suture methods and directions, resulting in massive bleeding. Once this occurs, an aortic side clamp needs to be used instead.

[0039] Compared with the Hearstring system and the Enclose system, the anastomosis system in this embodiment uses the occlusion balloon system 3 to block the local aortic blood, helping the surgeon to obtain a bloodless or even blood-free surgical field. Under the action of the filter 2, it can block accidentally detached plaques, ensuring the safety of the patient. Through the needle track 7, it provides stable support for the anastomotic bridging blood vessel and the aorta, reducing the anastomosis difficulty. Moreover, this anastomosis system is not a disposable consumable and can be reused, reducing the medical burden on the patient.

[0040] This embodiment is only an exemplary illustration of the present application and does not limit its protection scope. Those skilled in the art can also make local changes to it as long as they do not exceed the spiritual essence of the present application, and they are all within the protection scope of the present application.

Claims

1. A novel proximal aortic anastomosis system for coronary artery bypass grafting, characterized in that: The invention comprises a fixed tube (1), a filter (2), a blocking capsule system (3) and a delivery rod (4); the delivery rod (4) is sleeved in the fixed tube (1); the filter (2) is slidably arranged in the fixed tube (1); the delivery rod (4) is in contact with the filter (2); and the end of the delivery rod (4) is connected to the blocking capsule system (3).

2. A novel proximal aortic anastomosis system for coronary artery bypass grafting according to claim 1, characterized in that: The filter (2) is connected to a connection point (6) on the side wall of the fixed tube (1) via a traction line (5).

3. A novel proximal aortic anastomosis system for coronary artery bypass grafting according to claim 2, characterized in that: The fixed tube (1) is a hollow cylinder with a length of 100 mm, a diameter of 5 mm and an inner diameter of 4 mm.

4. The novel proximal aortic anastomosis system for coronary artery bypass grafting according to claim 3, characterized in that: The blocking capsule system (3) is a water capsule. A water inlet pipe is provided on the blocking capsule system (3). The water inlet pipe runs inside the delivery rod (4) and is connected to a syringe for water injection.

5. The novel proximal aortic anastomosis system for coronary artery bypass grafting according to claim 4, characterized in that: The tail end of the fixed tube (1) is processed with a needle rail (7).

6. A novel proximal aortic anastomosis system for coronary artery bypass grafting according to claim 4, characterized in that: The rear end of the fixing tube (1) is connected with a rubber sheet (8).

Images