Heart operation preset soft sheath for cardiac apex interventional therapy

Abstract

A heart surgery preset soft sheath for interventional therapy through a cardiac apex way comprises a sheath tube and a large head part arranged at the rear end of the sheath tube, the sheath tube is communicated with an inner cavity of the large head part, an air bag is arranged on the outer side face of the front end of the sheath tube, a plurality of sets of narrow kerfs and small holes which are communicated front and back are formed in the peripheral side of the large head part, and the narrow kerfs and the small holes in each set are in one-to-one correspondence. A containing cavity is formed in the large head portion, a blood blocking valve is arranged on a base of the containing cavity, a port is formed in the outer end of the large head portion, and in a free state, the blood blocking valve blocks the port. Through the structural design, the depth of the hemostasis purse-string can be limited, the hemostasis purse-string can be limited on the cardiac muscle, the sheath tube cannot slip off in the operation process, the hemostasis purse-string is integrally made of medical silica gel with the hardness of 50-65 degrees, the influence on contraction and expansion of the cardiac muscle is small, and the operation line of the hemostasis purse-string is tensioned and clamped and fixed on the large head after puncture. The hydrophilic films on the air bag and the sheathing canal can reduce damage to the cardiac muscle in the placing and taking-out process.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical devices, and in particular relates to a pre-placed soft sheath for cardiac surgery for interventional treatment via the apical approach. Background Art

[0002] The advantages of interventional treatment over surgical treatment are: ① No surgery is required, no wounds are made or only a skin incision of a few millimeters is needed to complete the treatment, so the trauma is minimal; ② Most patients only need local anesthesia rather than general anesthesia, which reduces the risk of anesthesia; ③ There is little damage to normal tissues, recovery is fast, and hospitalization time is short; ④ For elderly and critically ill patients who cannot tolerate surgery or patients who have no chance of surgery, interventional treatment can also provide good treatment.

[0003] In recent years, with the technological advancement of vascular sheaths, interventional treatment via vascular approaches has also developed well and is increasingly favored by medical staff and patients. For example, in artificial heart valve replacement surgery, a surgical channel from the outside of the body to the lumen of the blood vessel can be established on large blood vessels such as the femoral artery, femoral vein, and jugular vein through vascular puncture technology using a vascular sheath for surgical instruments to pass through. As a relatively mature medical device, the vascular sheath usually includes a sheath tube and a blood-blocking valve disposed in the sheath tube. Its specific structural form can refer to patent documents such as "Vascular Sheath" (application number: 202223206991.8), "Vascular Sheath Device and System" (application number: 202223245825.9), and "A Vascular Sheath Tube with Balloon" (application number: 202222833697.3).

[0004] At the same time, in the field of cardiac surgery technology such as repairing or replacing the mitral valve, aortic valve, tricuspid valve, pulmonary valve and ventricular septum, some doctors are also trying to use vascular sheaths to intervene through the apical approach. Before the operation, a hemostatic purse is sewed on the outer side of the myocardium corresponding to the apex of the heart. Figure 1 Six pieces of medical felt are pieced together into a hexagon, and two surgical threads are staggered to sew three pieces of medical felt to the outside of the myocardium. The two surgical threads are left with sufficient length and led out of the body. The center of the hexagon is set as the puncture area. After puncture in the puncture area, the vascular sheath is placed on the myocardium, and then the two surgical threads of the hemostatic purse are tightened to tighten the myocardium at the puncture site to the vascular sheath to prevent bleeding. The medical felt can refer to the felt sheet in the patent document "A felt sheet threading device" (application number: 202122213082.6).

[0005] The inventors of the present application, in their attempts to use a vascular sheath for transapical interventional treatment of heart surgery, generally felt that the operation was more convenient, which was conducive to shortening the operation, and the surgical effect was significantly better. However, limited by the structure of the vascular sheath itself, there are some inconveniences in the operation of cardiac surgery using a vascular sheath for transapical interventional treatment. For example, the vascular sheath is usually long, which makes it inconvenient to control the insertion depth. Sometimes the existing vascular sheath must be manually modified to avoid accidental injury to the heart tissue; there is no limiting mechanism on the vascular sheath, which makes it inconvenient to limit it on the myocardium. During the operation, attention must be paid to prevent the vascular sheath from being inserted too deeply and slipping off; there is no mechanism on the vascular sheath to fix the hemostatic purse surgical line, and it is time-consuming and laborious to lead the hemostatic purse surgical line out of the body to tighten and fix it, and it also affects the surgical operation space. Based on clinical practice operations, the inventors of the present application have made improvements on the structure of the vascular sheath, and thus proposed a pre-placed soft sheath for cardiac surgery for transapical interventional treatment. Summary of the invention

[0006] The utility model mainly solves the technical problems existing in the above-mentioned prior art and provides a pre-placed soft sheath for cardiac surgery for interventional treatment via the apical approach.

[0007] The above technical problems of the utility model are mainly solved by the following technical solutions: a pre-placed soft sheath for cardiac surgery for interventional treatment via the apical approach, comprising a sheath tube and a large head arranged at the rear end of the sheath tube, the inner cavities of the sheath tube and the large head are interconnected, an air bag is arranged on the outer side of the front end of the sheath tube, a first channel and a second channel are arranged along the tube wall of the sheath tube, corresponding to the first channel, a first opening is arranged on the tube wall of the sheath tube, the first channel is connected to the air bag via the first opening, corresponding to the second channel, a plurality of second openings are arranged on the tube wall of the sheath tube, the second channel is connected to the inner cavity of the sheath tube via the second opening, the first channel and the second channel extend backward along the sheath tube until passing through the large head, and are respectively connected to the hose interface arranged on the outer end surface of the large head, a plurality of groups of narrow slits and small holes are arranged on the circumference of the large head, the narrow slits and small holes in each group correspond to each other, the narrow slits are outside and the small holes are inside and the two are connected, a containing cavity is arranged in the large head, a blood blocking valve is arranged on the base of the containing cavity, and a port is arranged at the outer end of the large head, and the blood blocking valve is blocked on the port in a free state.

[0008] Preferably, the sheath tube and the large head are integrally made of medical silicone with a hardness of 50-65 degrees, and the airbag is made of high-elastic medical rubber, medical silicone, medical latex or medical polyurethane.

[0009] Preferably, the length L1 of the sheath is 2.0-3.0 cm, the wall thickness W1 of the sheath is 1.0-1.5 mm, and the diameter D of the inner cavity of the sheath is 3 The length L of the airbag is 1.5-2.0 cm 20.8-1.2 cm, thickness W 2 is 0.03-0.09 mm, and the diameter D of the accommodating cavity 1 Larger than the port diameter D 2 , the diameter of the port D 2 Larger than the diameter of the inner lumen of the sheath 3 .

[0010] Preferably, six or eight groups of narrow slits and small holes are provided on the circumference of the large head portion and extend through the large head portion.

[0011] Preferably, the blood blocking valve is a valve valve, and the valve valve is a prior art, and reference may be made to the patent document “A Bionic Valve Valve Structure” (application number: 201721454002.3).

[0012] Preferably, the outer surfaces of the airbag and the sheath are coated with a hydrophilic film, which is a hydrophilic polymer, and the hydrophilic polymer is polyethylene glycol, polyvinyl pyrrolidone, polyacrylamide, chitosan or hyaluronic acid.

[0013] In the utility model, the hose interface of the first channel is connected to the inflation and deflation device via the hose and the three-way valve on the hose, and the hose interface of the second channel is connected to the negative pressure device via the hose and the valve on the hose. These are all existing technologies and need no elaboration.

[0014] The utility model needs to be used together with a puncture device. The puncture device is a prior art, usually including an expansion handle and an expansion tube. A guide wire is arranged in the lumen of the expansion tube. For details, please refer to the expansion sheath and guide wire in the patent document "Vascular Sheath Device and System" (Application No.: 202223245825.9).

[0015] The sheath tube of the utility model is designed with various specifications between 2.0-3.0 cm in length to meet the needs of different patients. Before the operation, while examining the patient, the thickness of the patient's myocardium can be measured by cardiac B-ultrasound to select a pre-set soft sheath with a suitable sheath tube length.

[0016] Before puncture, sew the outer side of the myocardium corresponding to the apex of the heart. Figure 1 The hemostatic purse shown in the figure, the medical felt for sewing the hemostatic purse can refer to the felt sheet in the patent document "A felt sheet threading device" (application number: 202122213082.6), and then Figure 5 and Figure 6 As shown, the puncture device is assembled in the utility model, the expansion handle touches the port, the expansion tube passes through the sheath, the valve valve is compressed into the accommodating cavity and tightly fitted on the expansion tube, the guide wire passes through the lumen of the expansion tube, and its J-shaped elbow is suspended at the front end of the puncture device.

[0017] During puncture, the myocardium is first punctured with a steel needle at the center of the puncture area and the J-shaped elbow of the guide wire is inserted into the ventricle. Then, the expansion handle is held and the puncture device and the utility model are inserted into the ventricle along the guide wire. The airbag on the outer side of the front end of the sheath enters the ventricle, the main body of the sheath is embedded in the myocardium, and the large head is stuck on the outer side of the myocardium in the puncture area. Then, the airbag is inflated by the inflation and deflation device. Figure 7 As shown, after the airbag is inflated, it is clamped on the inner side of the myocardium, and the two surgical threads of the hemostatic purse are tightened at the same time, so that the myocardium in the puncture area is tightened on the sheath to prevent bleeding, and a group of narrow slits and small holes are selected nearby, and the surgical thread is introduced into the small hole through the narrow slit, and then the surgical thread is clamped and fixed on the corresponding small hole outer opening, and finally the puncture device and the guide wire are withdrawn, and the valve valve is re-blocked on the port, so that the utility model is pre-set on the myocardium, and the inner cavity connected by the sheath and the large head can be used as a channel for surgical instruments. During the puncture and operation, the puncture device, the utility model and the surgical instrument may bring a small amount of air into the ventricle to form blood foam, so it is necessary to open the negative pressure device and extract the blood foam out through the second channel to minimize the impact on the heart. After the heart surgery is completed, the gas in the airbag is first discharged, and then the clamped and fixed hemostatic purse surgical thread is disassembled and manually tightened, and the utility model is slowly taken out, and the puncture stoma is sutured.

[0018] The technical effect of using the utility model for heart surgery is obvious: 1. Through structural design, the depth of insertion into the ventricle can be limited, and it can be limited on the myocardium, and the sheath will not slip during the operation. 2. The soft sheath is made of medical silicone with a hardness of 50-65 degrees. After being pre-placed on the myocardium, it has little effect on the contraction and expansion of the myocardium. 3. After puncture, the surgical thread of the hemostatic purse is tightened and clamped on the large head, which does not affect the surgical space, and further limits the utility model, so that the sheath will not slip or rotate during the operation. 4. The outer surface of the airbag and the sheath is coated with a hydrophilic film. When placed, the hydrophilic film contacts the blood and can adhere to the moisture in the blood, so that the outer surface of the airbag and the sheath is lubricated, which can reduce the damage to the myocardium during the placement and removal process. Therefore, the utility model has the characteristics of simple structure and reasonable design. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 This is a structural schematic diagram of the hemostatic purse of the utility model;

[0020] Figure 2 It is a three-dimensional structural schematic diagram of the utility model;

[0021] Figure 3 It is a cross-sectional structural schematic diagram of the utility model;

[0022] Figure 4 It is a schematic diagram of a structure of the utility model pre-placed on the myocardium;

[0023] Figure 5 This is a three-dimensional structural schematic diagram of the utility model assembly trocar;

[0024] Figure 6 This is a schematic cross-sectional view of the assembled trocar of the utility model;

[0025] Figure 7 It is a schematic diagram of a cross-sectional structure during the puncture process of the utility model.

[0026] In the figure, 1-myocardium, 2-medical felt, 3-surgical line, 4-puncture area, 5-sheath, 51-airbag, 52-first channel, 53-second channel, 54-first opening, 55-second opening, 6-large head, 61-port, 62-narrow slit, 63-small hole, 64-accommodating cavity, 65-hose interface, 7-hose, 8-blood blocking valve, 9-puncture device, 91-expansion handle, 92-expansion tube, 93-lumen, 94-guide wire. DETAILED DESCRIPTION

[0027] The technical solution of the utility model is further specifically described below through embodiments and in conjunction with the accompanying drawings.

[0028] Example: See Figure 2 , Figure 3 and Figure 4 , a pre-placed soft sheath for cardiac surgery for interventional treatment via an apical approach, comprising a sheath tube and a large head arranged at the rear end of the sheath tube, the inner cavities of the sheath tube and the large head are connected, an air bag is arranged on the outer side surface of the front end of the sheath tube, a first channel and a second channel are arranged along the inner wall of the sheath tube, a first opening is arranged on the outer side surface of the front end of the sheath tube, the first opening is connected to the air bag, a plurality of second openings are arranged on the inner side surface of the sheath tube, the second opening is connected to the inner cavity of the sheath tube, the first channel and the second channel extend backward along the sheath tube until they pass through the large head, and are respectively connected to a hose interface arranged on the outer end surface of the large head, a plurality of groups of narrow slits and small holes are arranged on the circumference of the large head, the narrow slits and small holes in each group correspond to each other one by one, the narrow slits are outside and the small holes are inside and the two are connected, a accommodating cavity is arranged in the large head, a blood blocking valve is arranged on the base of the accommodating cavity, and a port is arranged at the outer end of the large head, and the blood blocking valve is blocked on the port in a free state. The sheath and the large head are made of medical silicone with a hardness of 50-65 degrees, and the airbag is made of high-elastic medical rubber, medical silicone, medical latex or medical polyimide. The length of the sheath is L 1 The wall thickness of the sheath is 2.0-3.0 cm. 1 The diameter of the inner lumen of the sheath is 1.0-1.5 mm. 3 The length L of the airbag is 1.5-2.0 cm 20.8-1.2 cm, thickness W 2 is 0.03-0.09 mm, and the diameter D of the accommodating cavity 1 Larger than the port diameter D 2 , the diameter of the port D 2 Larger than the diameter of the inner lumen of the sheath 3 ; Six or eight groups of narrow slits and small holes are provided on the circumferential side of the large head; the blood blocking valve is a valve valve, which is a prior art, and reference can be made to the patent document "A Bionic Valve Valve Structure" (application number: 201721454002.3); the outer surface of the airbag and the sheath is coated with a hydrophilic film, which is a hydrophilic polymer, and the hydrophilic polymer is polyethylene glycol, polyvinyl pyrrolidone, polyacrylamide, chitosan or hyaluronic acid.

[0029] In the utility model, the hose interface of the first channel is connected to the inflation and deflation device via the hose and the three-way valve on the hose, and the hose interface of the second channel is connected to the negative pressure device via the hose and the valve on the hose. These are all existing technologies and need no elaboration.

[0030] The utility model needs to be used together with a puncture device. The puncture device is a prior art, usually including an expansion handle and an expansion tube. A guide wire is arranged in the lumen of the expansion tube. For details, please refer to the expansion sheath and guide wire in the patent document "Vascular Sheath Device and System" (Application No.: 202223245825.9).

[0031] The sheath tube of the utility model is designed with various specifications between 2.0-3.0 cm in length to meet the needs of different patients. Before the operation, while examining the patient, the thickness of the patient's myocardium can be measured by cardiac ultrasound, CT or magnetic resonance imaging, so as to select a pre-set soft sheath with a suitable sheath tube length.

[0032] Before puncture, sew the outer side of the myocardium corresponding to the apex of the heart. Figure 1 The hemostatic purse shown in the figure, the medical felt for sewing the hemostatic purse can refer to the felt sheet in the patent document "A felt sheet threading device" (application number: 202122213082.6), and then Figure 5 and Figure 6 As shown, the puncture device is assembled in the utility model, the expansion handle touches the port, the expansion tube passes through the sheath, the valve valve is compressed into the accommodating cavity and tightly fitted on the expansion tube, the guide wire passes through the lumen of the expansion tube, and its J-shaped elbow is suspended at the front end of the puncture device.

[0033] During puncture, the myocardium is first punctured with a steel needle at the center of the puncture area and the J-shaped elbow of the guide wire is inserted into the ventricle. Then, the expansion handle is held and the puncture device and the utility model are inserted into the ventricle along the guide wire. The airbag on the outer side of the front end of the sheath enters the ventricle, the main body of the sheath is embedded in the myocardium, and the large head is stuck on the outer side of the myocardium in the puncture area. Then, the airbag is inflated by the inflation and deflation device. Figure 7 As shown, after the airbag is inflated, it is clamped on the inner side of the myocardium, and the two surgical threads of the hemostatic purse are tightened at the same time, so that the myocardium in the puncture area is tightened on the sheath to prevent bleeding, and a group of narrow slits and small holes are selected nearby, and the surgical thread is introduced into the small hole through the narrow slit, and then the surgical thread is clamped and fixed on the corresponding small hole outer opening, and finally the puncture device and the guide wire are withdrawn, and the valve valve is re-blocked on the port, so that the utility model is pre-set on the myocardium, and the inner cavity connected by the sheath and the large head can be used as a channel for surgical instruments. During the puncture and operation, the puncture device, the utility model and the surgical instrument may bring a small amount of air into the ventricle to form blood foam, so it is necessary to open the negative pressure device and extract the blood foam out through the second channel to minimize the impact on the heart. After the heart surgery is completed, the gas in the airbag is first discharged, and then the clamped and fixed hemostatic purse surgical thread is disassembled and manually tightened, and the utility model is slowly taken out, and the puncture stoma is sutured.

[0034] The technical effect of using the utility model for heart surgery is obvious: 1. Through structural design, the depth of insertion into the ventricle can be limited, and it can be limited on the myocardium, and the sheath will not slip during the operation. 2. The soft sheath is made of medical silicone with a hardness of 50-65 degrees. After being pre-placed on the myocardium, it has little effect on the contraction and expansion of the myocardium. 3. After puncture, the surgical thread of the hemostatic purse is tightened and clamped on the large head, which does not affect the surgical space, and further limits the utility model, so that the sheath will not slip or rotate during the operation. 4. The outer surface of the airbag and the sheath is coated with a hydrophilic film. When placed, the hydrophilic film contacts the blood and can adhere to the moisture in the blood, so that the outer surface of the airbag and the sheath is lubricated, which can reduce the damage to the myocardium during the placement and removal process. Therefore, the utility model has the characteristics of simple structure and reasonable design.

[0035] Finally, it should be pointed out that the above embodiments are only representative examples of the present utility model. Obviously, the present utility model is not limited to the above embodiments, and there are many variations. Any simple modification, equivalent changes and modifications made to the above embodiments based on the technical essence of the present utility model should be considered to belong to the protection scope of the present utility model.

Claims

1. A pre-placed soft sheath for cardiac surgery for transapical interventional therapy, comprising a sheath tube and a large head arranged at the rear end of the sheath tube, wherein the inner cavities of the sheath tube and the large head are interconnected, and characterized in that An airbag is provided on the outer side surface of the front end of the sheath tube, and a first channel and a second channel are provided on the wall of the sheath tube along the sheath tube. Corresponding to the first channel, a first opening is provided on the wall of the sheath tube, and the first channel is connected to the airbag via the first opening. Corresponding to the second channel, a plurality of second openings are provided on the wall of the sheath tube, and the second channel is connected to the inner cavity of the sheath tube via the second opening. The first channel and the second channel extend backward along the sheath tube until they pass through the big head, and are respectively connected to the hose interface arranged on the outer end surface of the big head. A plurality of groups of narrow slits and small holes that pass through the front and back are provided on the circumference of the big head. The narrow slits and small holes in each group correspond to each other one by one, the narrow slits are on the outside and the small holes are on the inside, and the two are connected. A accommodating cavity is provided in the big head, a blood blocking valve is provided on the base of the accommodating cavity, and a port is provided at the outer end of the big head, and the blood blocking valve is blocked on the port in a free state.

2. A pre-placed soft sheath for cardiac surgery for transapical interventional treatment according to claim 1, characterized in that The sheath tube and the large head are integrally made of medical silica gel with a hardness of 50-65 degrees, and the airbag is made of high-elastic medical rubber, medical silica gel, medical latex or medical polyimide.

3. A pre-placed soft sheath for cardiac surgery for transapical interventional treatment according to claim 1 or 2, characterized in that The length L1 of the sheath is 2.0-3.0 cm, the thickness W1 of the sheath wall is 1.0-1.5 mm, the diameter D3 of the sheath lumen is 1.5-2.0 cm, the length L2 of the airbag is 0.8-1.2 cm, the thickness W2 is 0.03-0.09 mm, and the diameter D1 of the accommodating cavity is greater than the diameter D2 of the port, and the diameter D2 of the port is greater than the diameter D3 of the sheath lumen.

4. A pre-placed soft sheath for cardiac surgery for transapical interventional treatment according to claim 1 or 2, characterized in that The circumference of the large head is provided with six or eight groups of narrow slits and small holes penetrating from front to back.

5. A pre-placed soft sheath for cardiac surgery for transapical interventional treatment according to claim 1 or 2, characterized in that The blood blocking valve is a valve valve.

6. A pre-placed soft sheath for cardiac surgery for transapical interventional treatment according to claim 1 or 2, characterized in that The outer surfaces of the airbag and the sheath are coated with a hydrophilic film.

7. A pre-placed soft sheath for cardiac surgery for transapical interventional treatment according to claim 6, characterized in that The hydrophilic membrane on the outer surface of the airbag and the sheath tube is a hydrophilic polymer.

8. A pre-placed soft sheath for transapical interventional cardiac surgery according to claim 7, characterized in that The hydrophilic polymer is polyethylene glycol, polyvinyl pyrrolidone, polyacrylamide, chitosan or hyaluronic acid.

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