Ascending aorta incision-free cardiac arrest liquid perfusion device

Abstract

The invention relates to an ascending aorta incision-free cardiac arrest fluid perfusion device which comprises a tube body used for supporting and guiding, a pushing tube arranged in the tube body and an umbrella-shaped cover arranged at the first end of the pushing tube, and an exhaust channel communicated with the interior of the umbrella-shaped cover is arranged in the pushing tube. The second end part of the pushing pipe is provided with a blocking part for blocking the exhaust channel; the umbrella-shaped cover comprises a plurality of elastic supporting ribs arranged in a circumferential array mode and a thin film cover arranged on the elastic supporting ribs, and the thin film cover is provided with a one-way valve circulation structure only enabling blood to flow out from inside to outside. When the device is used for perfusing the cardiopulmonary fluid into the coronary artery of the aorta, the ascending aorta can be prevented from being cut open, and the cardiopulmonary fluid can be perfused into the left coronary artery and the right coronary artery at the same time.

Description

Technical Field

[0001] The invention relates to a cardioplegic perfusion device, in particular to a cardioplegic perfusion device for avoiding incision of the ascending aorta in cardiac surgery. Background Art

[0002] Currently, patients with moderate to severe aortic regurgitation undergoing cardiac surgery require direct infusion of cardioplegic solution through the ascending aorta and the left and right coronary arteries to prevent aortic root perfusion, which could lead to regurgitation of perfusate into the left ventricle and myocardial injury due to excessive intraventricular pressure. While the first coronary artery is being perfused, the second is left unperfused and protected. This prolonged perfusion can lead to differential myocardial protection, resulting in poor myocardial protection. Furthermore, the currently used direct coronary perfusion device requires close monitoring during perfusion to prevent perfusate leakage. If perfusate leaks, the device's direction and insertion depth must be repeatedly adjusted. This leads to repeated friction between the perfusion device and the coronary lining, increasing the risk of intimal damage. Furthermore, separate perfusion of cardioplegic solution significantly prolongs the turnaround time, increases blood cell damage and coagulation factor consumption, prolongs surgery and anesthesia time, and increases perioperative risks for patients.

[0003] In addition, in order to reduce the trauma of cardiac surgery, more and more surgeries are choosing minimally invasive surgeries such as small incision surgery or laparoscopy. However, when there is a small or moderate amount of aortic valve regurgitation, the conventional cardiac arrest perfusion needle will cause the perfusion fluid to flow back into the left ventricle. Therefore, the non-incision cardiac arrest perfusion device is an urgently needed equipment in clinical practice.

[0004] A direct coronary perfusion tube disclosed in Chinese patent CN114984417A and Chinese patent CN222195696 U both cuts the ascending aorta wall to perform fractionated perfusion on the left and right coronary arteries. The aorta wall is still cut and perfusion is performed at the coronary artery opening, which increases the surgical operation process and the perfusion time. There is still the possibility of differential myocardial protection, and the transfer time is prolonged until the operation and anesthesia time are increased. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a device for perfusing cardiac arrest fluid without incising the ascending aorta, which avoids incising the ascending aorta and can simultaneously perfuse the left and right coronary arteries with cardiac arrest fluid.

[0006] In order to solve the above problems, the technical solution adopted by the present invention is: A device for instilling cardioplegic fluid into the ascending aorta without incision, the key technology of which is that it comprises a tube body for support and guidance, a push tube disposed within the tube body, and an umbrella-shaped cover disposed at a first end of the push tube; the proximal end of the tube body is used to connect to the incision hole in the aortic root, and the distal end is provided with a first blocking component for closing the tube body and fixing the push tube; the push tube is provided with an exhaust channel communicating with the interior of the umbrella-shaped cover; and the second end of the push tube is provided with a second blocking component for blocking the exhaust channel; The tube body is a flexible and deformable tube body, and a fixing ring for fixed connection with the aortic wall is provided at the proximal end of the tube body. The push tube is a deformable elastic tube. A perfusion tube for connecting to a cardioplegic fluid injection device is provided on the side wall of the proximal end of the tube body; The umbrella-shaped cover includes a plurality of elastic support bones arranged in a circumferential array and a thin film cover arranged on the elastic support bones. The thin film cover is provided with a one-way valve flow structure that only allows blood to flow out from the inside to the outside. After the umbrella-shaped cover is pushed out from the proximal end of the tube body by the push tube, the umbrella-shaped cover opens to cover the aortic valve. After the perfusion is completed, the umbrella-shaped cover can be put into the tube body through the pushing tube.

[0007] As a further improvement of the present invention, an opening is provided on the film cover between two adjacent elastic support bones, and a movable diaphragm is provided outside the opening. The movable diaphragm is opened outward by the internal pressure of the umbrella cover to open the opening, and the movable diaphragm is attached to the film cover by external pressure to close the opening, thereby forming a one-way valve for blood flow. Specifically, a fixed diaphragm and a movable diaphragm are provided between the two adjacent elastic support bones, and an overlapping portion is formed between the fixed diaphragm and the movable diaphragm, forming an opening for blood flow out at the overlapping portion, and the movable diaphragm is located outside the fixed diaphragm at the overlapping portion.

[0008] As a further improvement of the present invention, a lower fixing plate is fixedly arranged inside the tube body, a through hole is provided in the middle of the lower fixing plate for the push tube to pass through, the circumference of the lower fixing plate is sealed with the tube body, and the push tube is sealed and matched with the through hole of the lower fixing plate.

[0009] As a further improvement of the present invention, a proximal bend is provided at the first end of the push tube, and the proximal bend enables the umbrella-shaped cover to remain parallel to the aorta after being separated from the tube body.

[0010] As a further improvement of the present invention, a distal bending portion is provided at the second end of the pushing tube, and the bending direction of the distal bending portion is consistent with that of the proximal bending portion.

[0011] As a further improvement of the present invention, the second end of the pushing tube is fixedly connected to an operating ring.

[0012] As a further improvement of the present invention, a handle is symmetrically fixedly provided on the distal side wall of the tube body.

[0013] The beneficial effects of adopting the above technical solution are: The ascending aorta-free cardioplegia perfusion device provided by the present invention can avoid incising the ascending aorta when perfusing cardioplegia in patients with aortic regurgitation, and can simultaneously perform cardioplegia perfusion in the left and right coronary arteries, thereby reducing the time difference in cardioplegia perfusion and avoiding the possibility of differential myocardial protection or incomplete myocardial protection. For extracardiac surgery without aortic valve replacement, the invention can also reduce the time for aortic incision and suturing, avoid the occurrence of related injuries, and shorten the transfer, surgery, and anesthesia time, thereby correspondingly reducing the incidence of perioperative risks in patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 It is a structural schematic diagram of the present invention.

[0015] Figure 2 It is a schematic diagram of the use state of the present invention.

[0016] Figure 3 It is a structural schematic diagram of the umbrella cover of the present invention.

[0017] In the figure: 1 tube body, 2 handle, 3 push tube, 3-1 first end, 3-2 second end, 3-3 proximal bend, 3-4 distal bend, 4 fixing plug, 6 lower fixing plate, 8 umbrella cover, 9 exhaust hole, 10 perfusion tube, 11 tee, 12 fixing ring, 13 operating ring, 100 proximal end, 200 distal end, 300 aorta, 301 aortic valve, 302 incision hole. DETAILED DESCRIPTION

[0018] In order to make the objectives, technical solutions and advantages of the present invention more clear, the invention is clearly and completely described below in conjunction with specific embodiments.

[0019] like Figure 1 and Figure 2The device for instilling cardioplegic fluid in the ascending aorta without incision is shown. It includes a tubular body 1 for support and guidance, a push tube 3 disposed within the tubular body 1, and an umbrella-shaped cover 8 disposed at the first end 3-1 of the push tube 3. The proximal end 100 of the tubular body 1 is used to connect to the incision 302 in the aortic root. The distal end 200 of the tubular body 1 is provided with a first sealing component for sealing the tubular body 1 and securing the push tube 3. The first sealing component is a fixed plug 4, which is a frustoconical rubber plug. When removed, the fixed plug 4 is inserted into the push tube 3, allowing the push tube 3 to move axially along the tubular body 1. When the fixed plug 4 is inserted into the tubular body 1, it is squeezed to clamp the push tube 3, preventing it from moving relative to the tubular body 1. A handle 2 is symmetrically fixed to the sidewall of the distal end 200 of the tubular body 1.

[0020] A perfusion tube 10 for connecting to a cardioplegic perfusion device is provided on the sidewall of the proximal end 100 of the tubular body 1. A tee 11 is provided at the end of the perfusion tube 10. After the cardioplegic perfusion device of this embodiment is installed, cardioplegic fluid can be directly injected into the tubular body 1 through the tee 11 and perfusion tube 10. The cardioplegic fluid flows from the proximal end of the tubular body 1 into the space between the aorta 300 and the umbrella-shaped cover, and then into the left and right coronary arteries.

[0021] The push tube 3 is provided with an exhaust channel connected to the interior of the umbrella-shaped cover 8, and the second end 3-2 of the push tube 3 is provided with a second blocking component for blocking the exhaust channel. In this embodiment, the second blocking component is a plug for blocking the exhaust port 9 or a stop valve provided at the second end 3-2 of the push tube 3, or other components capable of achieving exhaust and flow stop. The plug 9 is directly installed at the end of the second end 3-2 of the push tube 3; when the tube body 1 is placed in the aortic purse string incision, blood is automatically exhausted through the exhaust channel formed by the umbrella-shaped cover 8 and the push tube 3.

[0022] As another embodiment, the end of the second end portion 3 - 2 of the push tube 3 may be closed, and an exhaust branch pipe may be provided on its side wall, and an opening and closing mechanism (such as an exhaust valve) may be provided on the branch pipe to achieve exhaust.

[0023] like Figure 1 and Figure 2As shown, a lower fixing plate 6 is fixedly installed inside the tube body 1. A through-hole is provided in the middle of the lower fixing plate 6 for the push tube 3 to pass through. The circumference of the lower fixing plate 6 is sealed with the tube body 1, and the push tube 3 and the through-hole of the lower fixing plate 6 are sealed. The lower fixing plate 6 divides the tube body 1 into two upper and lower chambers. The lower chamber is used to accommodate the umbrella-shaped cover 8, and the upper and lower chambers are isolated from each other to prevent blood from flowing into the entire tube body 1 through the lower chamber. (If blood overflows into the upper cavity of the tube body 1 through the hole in the fixing plate 6, the fixing plug 4 at the upper end of the tube body 1 can be opened. After the air is exhausted, the fixing plug 4 can be gently inserted into the upper end of the tube body 1. Once the umbrella-shaped cover is in place, the fixing plug 4 can be tightened, or the tube body 1 can be tightened with pipe clamps to fix the umbrella-shaped cover in place.)

[0024] To facilitate a possible secondary perfusion procedure, the device is left in place after perfusion is complete and not removed. Only the umbrella cover 8 is retracted into the tubular body 1 and secured with a pipe clamp. Therefore, the tubular body 1 is flexible and deformable. A retaining ring 12 is provided at the proximal end 100 of the tubular body 1 for secure connection to the aortic wall. The push tube 3 is a deformable elastic tubular member. Because both the tubular body 1 and the push tube 3 are flexible and deformable, the overall shape of the perfusion device of this embodiment is adjustable. The tubular body 1 is flexible, kink-resistant, and controllable. It can be made of plastic or a combination of multilayer composite materials and alloys (e.g., a polyurethane outer layer, a nickel-titanium alloy spiral or braided middle layer, and a polytetrafluoroethylene inner layer).

[0025] To accommodate the orientation of the aorta (e.g. Figure 2 As shown), the first end 3-1 of the push tube 3 is provided with a proximal bend 3-3, and the proximal bend 3-3 enables the umbrella-shaped cover 8 to cover the aortic valve 301 after being separated from the tube body 1. The second end 3-2 of the push tube 3 is provided with a distal bend 3-4, and the bending direction of the distal bend 3-4 is consistent with that of the proximal bend 3-3. In this way, the specific orientation of the proximal bend 3-3 and the umbrella-shaped cover 8 can be directly observed from the distal bend 3-4, which is convenient for operation. The second end 3-2 of the push tube 3 is fixedly connected to an operating ring 13, and the operating ring 13 is on the same plane as the plane where the proximal bend 3-3 and the distal bend 3-4 are located, which facilitates the completion of the aortic valve closure operation and determines that the coronary artery opening is in an open state by observing the perfusion pressure. This operation can also be completed under esophageal ultrasound monitoring, which reduces the possibility that the aortic valve is not completely covered or the coronary artery opening is blocked.

[0026] like Figure 3As shown, the umbrella-shaped cover 8 comprises a plurality of elastic support ribs 8-1 arranged in a circumferential array and a thin film cover disposed on the elastic support ribs 8-1. The thin film cover is provided with a one-way valve flow structure that only allows blood to flow from the inside to the outside. After the umbrella-shaped cover 8 is pushed out of the proximal end 100 of the tube body 1 by the push tube 3, the umbrella-shaped cover 8 opens to cover the aortic valve. The top ends of the plurality of elastic support ribs 8-1 are fixedly connected to the connector 8-5, which is fixedly connected to the push tube 3.

[0027] The umbrella-shaped cover 8 allows the blood flowing out of the aorta to flow out to the coronary arteries through the one-way valve flow structure thereon, but cannot flow back. This also ensures that when the cardioplegic fluid is perfused, the cardioplegic fluid can smoothly enter the coronary arteries, thereby reducing the backflow of fluid through the aortic valve to the left ventricle and excessive expansion of the ventricle, causing myocardial damage.

[0028] An opening is provided on the film cover between the two adjacent elastic support bones 8-1 of the umbrella-shaped cover 8, and a movable diaphragm is provided outside the opening. The movable diaphragm is opened outward by the internal pressure of the umbrella-shaped cover 8 to open the opening, and the movable diaphragm is attached to the film cover by external pressure to close the opening.

[0029] Figure 3 The diagram shows an embodiment of an umbrella-shaped cover 8. A fixed diaphragm 8-2 and a movable diaphragm 8-3 are disposed between two adjacent elastic support bones 8-1. The fixed diaphragms 8-2 and movable diaphragms 8-3 together constitute the thin film cover. An overlapping portion is formed between the fixed diaphragms 8-2 and the movable diaphragms 8-3. An opening 8-4 is formed at the overlapping portion, allowing blood to flow out. The movable diaphragm 8-3 is located outside the fixed diaphragm 8-2 at the overlapping portion. The movable diaphragm 8-3 is opened outward by pressure from within the umbrella-shaped cover 8, opening the opening 8-4. External pressure causes the movable diaphragm 8-3 to adhere to the thin film cover, closing the opening 8-4. The fixed diaphragm 8-2 is made of an inelastic material, while the movable diaphragm 8-3 is made of an elastic material. The upper and lower corners of the fixed diaphragm 8-2 and movable diaphragm 8-3 at the overlapping portion are sewn together, while the side where the movable diaphragm 8-3 overlaps with the fixed diaphragm 8-2 is not fixed. When the heart ejects blood, the aortic valve opens. When the pressure inside the aorta is too high, the unfixed side of the movable diaphragm 8-3 is pressed outward, so that the overlapping part of the fixed diaphragm 8-2 and the movable diaphragm 8-3 opens to form the opening 8-4. Otherwise, the overlapping part of the fixed diaphragm 8-2 and the movable diaphragm 8-3 fits together, so that the opening 8-4 is closed.

[0030] As a preferred embodiment, the outer side surface of the umbrella-shaped cover 8 is concave, so that after the umbrella-shaped cover 8 covers the aortic valve 301, space is left between the umbrella-shaped cover 8 and the opening of the coronary artery, allowing unobstructed perfusion of the cardioplegic solution.

[0031] The specific usage of the ascending aorta-free cardioplegia perfusion device described in this embodiment is as follows: To prepare for coronary perfusion, occlude the ascending aorta. A purse-string suture is placed at the aortic root (or where the aortotomy is planned). A hole 302 is made in the purse-string, and the needle tip of the proximal end 100 of the tube 1 is placed in the hole 302. The retaining ring 12 is secured to the aorta 300 via the suture. Observe that the vent hole 3-2 at the second end 3-2 of the delivery tube 3 is filled with blood, and gas is discharged through the vent hole 9 at the head end. If the upper end of the fixing plate 6 of the tube 1 is congested with blood, the upper space of the tube 1 can be vented by separating the fixing plug 4 at the upper end of the tube 1. After the tube is vented, the vent hole 9 is closed.

[0032] Then, gently loosen the fixing plug 4 to facilitate the movement of the push tube 3. The umbrella-shaped cover 8 is pushed inward into the aorta through the push tube 3. The umbrella-shaped cover 8 automatically expands under the action of the elastic support bone 8-1 until the front end of the umbrella-shaped cover 8 is pressed against and cannot be pushed. The umbrella-shaped cover is moved left and right, and then gently pressurizes the push tube 3 to fix the umbrella-shaped cover 8 and prevent it from moving left and right. The placement of the umbrella-shaped cover 8 is completed. The umbrella-shaped cover 8 is placed on the aortic valve, allowing blood to flow out but preventing reverse flow.

[0033] Then test the perfusion pressure. If the perfusion pressure is normal and there is no left heart enlargement, the placement of the aortic valve umbrella cover is completed. The fixing plug 4 is tightly inserted into the distal end of the tube body 1 to fix the position of the push tube 3, or the tube body 1 is clamped with a pipe clamp at the same time. This operation process can also be completed under the monitoring of esophageal ultrasound. If the perfusion pressure increases after the placement of the umbrella cover, the position of the umbrella cover affects the opening of the coronary artery. It is necessary to continue to adjust the position of the umbrella cover 8 and relax the pressure of the push tube 3. The direction of the proximal bend 3-3 can be adjusted by pushing or rotating the direction of the distal bend 3-4. After adjusting the position of the umbrella cover 8, observe the perfusion pressure until the perfusion pressure is normal and the left ventricular pressure remains unchanged. The placement of the umbrella cover is completed.

[0034] Cardioplegia perfusion is performed at the aortic root using the cardioplegia perfusion device connected to the tee 11. After the perfusion is completed, the fixing plug 4 on the push tube 3 is loosened, or the pipe clamp is simultaneously loosened, and the push tube 3 is pulled outward, and the umbrella cover 8 is able to rebound into the tube body 1, and the operation can then be continued.

[0035] Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art may still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein; and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A device for cardioplegic perfusion without incision of the ascending aorta, characterized by: It comprises a tube body (1) for supporting and guiding, a push tube (3) arranged in the tube body (1), and an umbrella-shaped cover (8) arranged at the first end (3-1) of the push tube (3); the proximal end (100) of the tube body (1) is used to connect to the incision hole of the aortic root, the distal end (200) is provided with a first blocking component for closing the tube body (1) and fixing the push tube (3), the push tube (3) is provided with an exhaust channel connected to the interior of the umbrella-shaped cover (8), and the second end (3-2) of the push tube (3) is provided with a second blocking component for blocking the exhaust channel; The tube body (1) is a flexible and deformable tube body, and the proximal end (100) of the tube body (1) is provided with a fixing ring (12) for fixed connection with the aorta wall, and the pushing tube (3) is a deformable elastic tube. A perfusion tube (10) for connecting to a cardioplegic fluid management device is provided on the side wall of the proximal end (100) of the tube body (1); The umbrella-shaped cover (8) comprises a plurality of elastic support bones (8-1) arranged in a circumferential array and a thin film cover arranged on the elastic support bones (8-1). The thin film cover is provided with a one-way valve flow structure that only allows blood to flow out from the inside to the outside. After the umbrella-shaped cover (8) is pushed out from the proximal end (100) of the tube body (1) by the push tube (3), the umbrella-shaped cover (8) opens to cover the aortic valve.

2. The ascending aorta cardioplegia perfusion device according to claim 1, characterized in that: An opening is provided on the film cover between two adjacent elastic support bones (8-1), and a movable diaphragm is provided outside the opening. The movable diaphragm is opened outward by the internal pressure of the umbrella-shaped cover (8) to open the opening, and the movable diaphragm is attached to the film cover by external pressure to close the opening.

3. The ascending aorta cardioplegia perfusion device according to claim 1, characterized in that: A fixed diaphragm (8-2) and a movable diaphragm (8-3) are provided between two adjacent elastic support bones (8-1); the entire fixed diaphragm (8-2) and the movable diaphragm (8-3) constitute the film cover; an overlapping portion is formed between the fixed diaphragm (8-2) and the movable diaphragm (8-3); an opening (8-4) for blood to flow out is formed at the overlapping portion; the movable diaphragm (8-3) is located outside the fixed diaphragm (8-2) at the overlapping portion; the movable diaphragm (8-3) is opened outward by the internal pressure of the umbrella-shaped cover (8) to open the opening (8-4); and the movable diaphragm (8-3) is attached to the film cover by external pressure to close the opening (8-4).

4. The ascending aorta cardioplegia perfusion device according to claim 1, characterized in that: A lower fixing plate (6) is fixedly provided inside the tube body (1), a through hole is provided in the middle of the lower fixing plate (6) for the push tube (3) to pass through, the circumference of the lower fixing plate (6) is sealed and connected to the tube body (1), and the push tube (3) and the through hole of the lower fixing plate (6) are sealed and matched.

5. The ascending aorta cardioplegia perfusion device according to claim 1, characterized in that: A proximal bend (3-3) is provided at the first end (3-1) of the push tube (3), and the proximal bend (3-3) enables the umbrella cover (8) to remain parallel to the aorta after being separated from the tube body (1).

6. The ascending aorta cardioplegia perfusion device according to claim 5, characterized in that: A distal bending portion (3-4) is provided at the second end portion (3-2) of the push tube (3), and the bending direction of the distal bending portion (3-4) is consistent with that of the proximal bending portion (3-3).

7. The ascending aorta cardioplegia perfusion device according to claim 6, characterized in that: The second end portion (3-2) of the push tube (3) is fixedly connected to an operating ring (13).

8. The ascending aorta cardioplegia perfusion device according to claim 1, characterized in that: A handle (2) is symmetrically fixedly provided on the side wall of the distal end (200) of the tube body (1).

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