Assembling method for conveying valve prosthesis

Abstract

The invention relates to the technical field of medical instruments, in particular to an assembling method for conveying a valve prosthesis, which is characterized in that a fixing mechanism is arranged, and a spiral blade is driven to rotate by rotating an adjusting ring, so that an inner hole formed in the spiral blade is shrunk to be clamped with an inner catheter; the bending between the inner catheter and the outer catheter is further locked, so that the situation that a worker always needs to manually lock the sheathing canal is avoided, the operation process is greatly simplified, and the operation difficulty is reduced.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to an assembly method for delivering a valve prosthesis. Background Art

[0002] A valve prosthesis is a biological material specifically used for the treatment of heart disease. It is an artificial heart valve composed of biological materials or mainly made of biological materials. Based on the source of the material, valve prostheses are mainly divided into two categories: homologous valves and xenogeneic valves. Homologous valves refer to valves made using the patient's own tissues or tissues from other individuals of the same species, while xenogeneic valves include materials from other species such as porcine aortic valves and bovine pericardial valves. Valve prostheses perform well in restoring cardiac function, have excellent hemodynamic properties, and do not require long-term anticoagulation therapy. This makes the risk of thromboembolism relatively low, while also avoiding problems such as fatal bleeding that may be caused by anticoagulation therapy; However, in the process of delivering the valve prosthesis, the assistance of an interventional sheath is usually required. However, in the process of delivering the valve prosthesis, the existing interventional sheath needs to be bent and cannot lock the bent sheath. Therefore, the staff needs to manually lock the sheath during the interventional treatment. This method is very cumbersome and increases the difficulty of the operation.

[0003] Therefore, the present invention designs an assembly method for valve prosthesis delivery to solve the above-mentioned technical problems. Summary of the invention

[0004] Technical problem to be solved by the present invention: In the process of delivering valve prosthesis, the assistance of interventional sheath is usually required. However, in the process of delivering valve prosthesis, the existing interventional sheath needs to be bent, but the bent sheath cannot be locked. Therefore, the staff needs to manually lock the sheath during the interventional treatment. This method is very cumbersome and also increases the difficulty of the operation.

[0005] The present invention provides the following technical solution: an assembly method for valve prosthesis delivery, characterized in that it comprises the following steps: S1: Provide a handle, a catheter, an outer catheter and a liquid injection device, insert the catheter into the designated position of the handle, connect the liquid injection device to the catheter, and use the liquid injection device to inject liquid into the catheter through the other end of the catheter S2: Place the outer catheter into the human body, insert the inner catheter and then inflate the inside of the bending airbag. After the bending airbag is restarted, pull the inner catheter to bend the outer catheter.

[0006] S3: At this time, the adjusting ring in the fixing mechanism is rotated to make the spiral blades close and engage with the matching grooves outside the inner catheter to complete the fixation of the catheter.

[0007] S4: At this time, the heart valve is inserted into the inner catheter through the guide sheath, and the inner catheter is extended to the designated position to complete the delivery of the valve prosthesis.

[0008] Preferably, the fixing mechanism includes a fixing ring, an adjusting ring, a fixing column, a rotating gear, a spiral blade and an adjusting tooth, the fixing ring is mounted on the handle, and the fixing ring is used to fix the entire fixing mechanism on the handle; the fixing ring is mounted with an adjusting ring, and the adjusting ring is used to rotate and adjust the size of the inner hole composed of the spiral blades to thereby fix the inner catheter; the annular array of fixing columns is mounted on the fixing ring; the fixing column is used to fix the rotating gear; the fixing column is mounted with a rotating gear, and the rotating gear is used to rotate and thereby drive the spiral blade to rotate; the spiral blade is mounted on the rotating gear, and the spiral blade is used to rotate and thereby adjust the size of the inner hole; the adjusting ring is mounted with an adjusting tooth meshing with the rotating gear, and the adjusting tooth is used to drive the rotating gear to rotate when the adjusting ring is manually grasped, thereby fixing the inner catheter.

[0009] Preferably, the spiral blades are in a crescent shape, and the rotation directions of the spiral blades are consistent. The crescent-shaped spiral blades can form a circular through hole during rotation, and the size of the circular through hole can be adjusted as the crescent-shaped spiral blades rotate, thereby adjusting the fixation of inner catheters with different inner diameters; and the rotation directions of the spiral blades are consistent in order to avoid mutual interference between the spiral blades during rotation, thereby affecting the operation of the fixing mechanism.

[0010] Preferably, an anti-skid gasket is installed between the fixed ring and the adjustable ring. The anti-skid gasket is installed between the fixed ring and the adjustable ring. The anti-skid gasket is used to increase the friction between the fixed ring and the adjustable ring, so that the adjustable ring can be kept fixed after the staff does not control the adjustable ring, and the fixing mechanism can be cooperated with to better realize the control of the inner catheter.

[0011] Preferably, the adjusting ring is provided with anti-slip patterns. The anti-slip patterns are provided on the adjusting ring to enable the staff to better rotate the adjusting ring. Since the adjusting ring is installed on the fixed ring and the adjusting ring is a circular structure, it is necessary to provide anti-slip patterns here. The anti-slip patterns are provided as gear-shaped protrusions, so that the staff can still smoothly rotate the adjusting ring when wearing gloves.

[0012] Preferably, a matching groove is provided on the handle at the end of the catheter, and the matching groove is used to engage with the spiral blade so as to achieve better fixation of the catheter by the fixing mechanism; a plurality of matching grooves are arranged in an array at the end of the catheter, so as to achieve control of inner catheters with different degrees of bending. After adjusting the fixing mechanism, the rotating spiral blade can be engaged in the matching groove of the inner catheter to fix the inner catheter.

[0013] Preferably, a bending mechanism is installed at the end of the catheter, and the bending mechanism includes a bending airbag, an air hole and an airway. The bending airbag is installed at the end of the catheter and is connected with the catheter, and the bending airbag is used to cooperate with the inner catheter to bend the outer catheter and the inner catheter; an air hole is opened on the bending airbag, and an airway is arranged in the catheter, the air hole is connected with the airway, and the air hole and the airway are used to introduce air into the bending airbag.

[0014] Preferably, a guide hole for the passage of a valve prosthesis is provided in the bending airbag, and a fixed bracket is installed on the top of the bending airbag, and the fixed bracket is deployed along with the deployment of the bending airbag; a guide hole is provided in the bending airbag for the passage of a valve prosthesis, and a fixed bracket is installed on the top of the bending airbag to support the outer catheter when the airbag is expanded, so that the outer catheter and the inner catheter are bent at the same time when the inner catheter is pulled, and the bracket used is a retractable bracket, which can be retracted when the bending airbag is evacuated.

[0015] Preferably, a conical auxiliary cavity for assisting the expansion and recovery of the heart valve is provided at the position of the guide hole near the end of the airbag; the conical auxiliary cavity is provided at the end of the airbag to gradually expand the valve prosthesis when the valve prosthesis is expanded, thereby achieving a protective effect on the valve prosthesis, and also can preliminarily determine whether the position of the valve prosthesis is appropriate, thereby increasing the success rate of the operation; at the same time, when retracting the valve prosthesis, the existence of the conical auxiliary cavity can also achieve its rapid contraction.

[0016] The beneficial effects of the present invention are as follows: 1. The present invention sets a fixing mechanism, and drives the spiral blade to rotate by rotating the adjusting ring, so that the inner hole formed inside the spiral blade shrinks and clamps with the inner catheter, thereby locking the bend between the inner catheter and the outer catheter, avoiding the need for staff to manually lock the sheath, greatly simplifying the operation process and reducing the difficulty of the operation.

[0017] 2. The present invention provides a bending mechanism, and the catheter can be bent by bending the airbag. Compared with the existing bending method, it can be quickly adjusted, and can be quickly locked with the fixing mechanism, thereby achieving a better delivery effect. In addition, the airbag is made of a retractable material, and can be contracted by negative pressure when not bent, which greatly facilitates the operation of the staff. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0019] Figure 1 is a flow chart of the method of the present invention; Figure 2 It is an overall schematic diagram of the present invention; Figure 3 It is a schematic diagram of the fixing mechanism of the present invention; Figure 4 It is a schematic diagram of the fixing mechanism of the present invention when it is working; Figure 5 It is a schematic diagram of the spiral blade of the present invention; Figure 6 It is a side view of the fixing mechanism of the present invention; Figure 7 This is an enlarged view of point A of the present invention; Figure 8 A schematic diagram of a matching groove of the present invention; Fig. 9 It is a schematic diagram of the bending mechanism of the present invention; Fig.10 It is a schematic diagram of the top of the bent airbag of the present invention; Fig.11 It is a cross-sectional view of the bent airbag of the present invention.

[0020] In the figure: 1. fixing mechanism; 11. fixing ring; 12. adjusting ring; 13. fixing column; 14. rotating gear; 15. spiral blade; 16. adjusting tooth; 17. anti-skid pad; 18. anti-skid pattern; 2. outer catheter; 3. inner catheter; 31. matching groove; 4. bending mechanism; 41. bending airbag; 42. air hole; 43. airway; 44. guide hole; 45. fixing bracket; 46. conical auxiliary cavity; 5. handle; 6. catheter; 7. liquid injection device. DETAILED DESCRIPTION

[0021] In order to make the purpose, technical scheme and advantages of the embodiments of the present invention clearer, the technical scheme in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. Therefore, the following detailed description of the embodiments of the present invention is not intended to limit the scope of the claimed invention, but merely represents some embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0022] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0023] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", "back" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, or the positions or positional relationships in which the product of the invention is usually placed when in use. Such terms are only used to facilitate the description of the present invention and simplify the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as limiting the present invention.

[0024] It should also be noted that in the description of the present invention, unless otherwise clearly specified and limited, the terms "set", "install", "connect", and "connect" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0025] The disclosed embodiments are intended to solve the problem that in the existing process of delivering valve prostheses, the assistance of an interventional sheath is usually required. However, in the process of delivering valve prostheses, the existing interventional sheaths cannot lock the bent sheaths when the sheaths need to be bent. Therefore, the staff needs to manually lock the sheaths during the interventional treatment. This method is very cumbersome and increases the difficulty of the operation. In view of this, the disclosed embodiments propose an assembly method for delivering valve prostheses, which drives the spiral blades to rotate by rotating the adjusting ring, so that the inner hole formed inside the spiral blades shrinks and clamps with the inner catheter, thereby locking the bend between the inner catheter and the outer catheter, avoiding the need for the staff to manually lock the sheaths all the time, greatly simplifying the operation process and reducing the difficulty of the operation.

[0026] like Figures 1 to 11 As shown, an assembly method for valve prosthesis delivery comprises the following steps: S1: Provide a handle 5, a catheter 6, an outer catheter 2 and a liquid injection device 7, insert the catheter 6 into a designated position of the handle 5, connect the liquid injection device 7 to the catheter 6, and use the liquid injection device 7 to inject liquid into the catheter through the other end of the catheter 6 S2: insert the outer catheter 2 into the human body, insert the inner catheter 3 and then inflate the inside of the bending airbag 41. After the bending airbag 41 is restarted, pull the inner catheter 3 to bend the outer catheter 2.

[0027] S3: At this time, the adjusting ring 12 in the fixing mechanism 1 is rotated to make the spiral blades 15 close and engage with the matching grooves 31 outside the inner catheter 3, thereby completing the fixing of the catheter.

[0028] S4: At this time, the heart valve is inserted into the inner catheter 3 through the guide sheath, and the inner catheter 3 is extended to the designated position to complete the delivery of the valve prosthesis.

[0029] like Figures 1 to 8As shown, the fixing mechanism 1 includes a fixing ring 11, an adjusting ring 12, a fixing column 13, a rotating gear 14, a spiral blade 15 and an adjusting tooth 16. The fixing ring 11 is installed on the handle 5, and the fixing ring 11 is used to fix the entire fixing mechanism 1 on the handle 5; the fixing ring 11 is installed with an adjusting ring 12, and the adjusting ring 12 is used to rotate and adjust the size of the inner hole composed of the spiral blade 15 to fix the inner catheter 3; the fixing columns 13 are installed in a circular array on the fixing ring 11; the fixing columns 13 are used to fix the rotating gear 14; the fixing columns 13 are installed with a rotating gear 14, and the rotating gear 14 is used to rotate and drive the spiral blade 15 to rotate; the spiral blade 15 is installed on the rotating gear 14, and the spiral blade 15 is used to rotate and adjust the size of the inner hole; the adjusting ring 12 is installed with an adjusting tooth 16 meshing with the rotating gear 14, and the adjusting tooth 16 is used to drive the rotating gear 14 to rotate when the adjusting ring 12 is manually grasped, thereby fixing the inner catheter 3; During operation, after the inner catheter 3 is inserted into the outer catheter 2, the staff inflates the inner catheter 3 through the airway 43. After the bending airbag 41 is filled, the staff only needs to pull the inner catheter 3 to make the inner catheter 3 drive the outer catheter 2 to bend together. After controlling the bending angle and direction, it is only necessary to rotate the adjusting ring 12. The adjusting ring 12 rotates and drives the rotating gear 14 to rotate around the fixing column 13 through the adjusting tooth 16. The rotating gear 14 rotates and drives the spiral blade 15 to rotate. The spiral blade 15 rotates to shrink the inner hole formed by it, thereby fixing the inner catheter 3.

[0030] By adopting the above-mentioned fixed structure, the spiral blade 15 can be driven to rotate by rotating the adjusting ring 12, so that the inner hole formed inside the spiral blade 15 shrinks and clamps with the inner catheter 3, thereby locking the bend between the inner catheter 3 and the outer catheter 2, avoiding the need for staff to manually lock the sheath all the time, greatly simplifying the operation process and reducing the difficulty of the operation.

[0031] like Figure 5 As shown, the spiral blade 15 is in a crescent shape, and the rotation direction of the spiral blade 15 is consistent. The crescent-shaped spiral blade 15 can form a circular through hole during rotation, and the size of the circular through hole can be adjusted as the crescent-shaped spiral blade 15 rotates, thereby adjusting the fixation of the inner catheter 3 with different inner diameters; at the same time, the rotation direction of the spiral blade 15 is consistent to avoid mutual interference between the spiral blades 15 during rotation, thereby affecting the operation of the fixing mechanism 1.

[0032] like Figure 7As shown, an anti-skid gasket 17 is installed between the fixed ring 11 and the adjusting ring 12. The anti-skid gasket 17 is installed between the fixed ring 11 and the adjusting ring 12. The anti-skid gasket 17 is used to increase the friction between the fixed ring 11 and the adjusting ring 12, so that the adjusting ring 12 can be kept fixed after the staff does not control the adjusting ring 12, and the fixing mechanism 1 can be used to better control the inner catheter 3.

[0033] like Figure 7 As shown, the adjusting ring 12 is provided with anti-slip grooves 18. The anti-slip grooves 18 are provided on the adjusting ring 12 to enable the staff to better rotate the adjusting ring 12. Since the adjusting ring 12 is installed on the fixed ring 11, and the adjusting ring 12 is a circular structure, it is necessary to provide the anti-slip grooves 18. The anti-slip grooves 18 are configured as gear-shaped protrusions, so that the staff can still smoothly rotate the adjusting ring 12 when wearing gloves.

[0034] like Figure 8 As shown, the end of the catheter is provided with a matching groove 31 at the handle 5, and the matching groove 31 is used to engage with the spiral blade 15 so as to achieve better fixation of the catheter by the fixing mechanism 1; a plurality of matching grooves 31 are arranged in an array at the end of the catheter, so as to achieve control of the inner catheter 3 with different bending degrees. After adjusting the fixing mechanism 1, the rotating spiral blade 15 can be engaged in the matching groove 31 of the inner catheter 3, so as to fix the inner catheter 3.

[0035] like Figures 9 to 11 As shown, a bending mechanism 4 is installed at the end of the catheter, and the bending mechanism 4 includes a bending airbag 41, an air hole 42 and an airway 43. The bending airbag 41 is installed at the end of the catheter and is connected with the catheter. The bending airbag 41 is used to cooperate with the inner catheter 3 to bend the outer catheter 2 and the inner catheter 3; an air hole 42 is opened on the bending airbag 41, and an airway 43 is arranged in the catheter. The air hole 42 is connected with the airway 43, and the air hole 42 and the airway 43 are used to introduce air into the bending airbag 41.

[0036] During operation, the inflation device is first used to inflate the bending airbag 41 through the airway 43 and the air hole 42, and then the outer catheter 2 of the bending airbag 41 is bent. At this time, the inner catheter 3 and the outer catheter 2 are bent by pulling the inner catheter 3, thereby achieving control over the degree of catheter bending. The airbag can also be used to move the inner catheter 3 to the outer catheter 2 so that it can be transported normally. The airbag is made of soft material and will not damage human tissue during the movement.

[0037] The bending mechanism 4 can be used to bend the catheter through airbag bending, which can achieve rapid adjustment compared to the existing bending method, and can be quickly locked in conjunction with the fixing mechanism 1, thereby achieving a better delivery effect. The airbag is made of a retractable material and can be contracted by negative pressure when not bent, greatly facilitating the operation of the staff.

[0038] like Fig.10 As shown, the bending airbag 41 is provided with a guide hole 44 for the valve prosthesis to pass through, and a fixed bracket 45 is installed on the top of the bending airbag 41, and the fixed bracket 45 is deployed along with the deployment of the bending airbag 41; a guide hole 44 is provided in the bending airbag 41 for the valve prosthesis to pass through, and a fixed bracket 45 is installed on the top of the bending airbag 41 to support the outer catheter 2 when the airbag is expanded, so that the outer catheter 2 and the inner catheter 3 are bent at the same time when the inner catheter 3 is pulled, and the bracket used is a retractable bracket, which can be retracted when the bending airbag 41 is evacuated.

[0039] like Fig.11 As shown, the guide hole 44 is provided with a conical auxiliary cavity 46 near the end of the airbag for assisting the expansion and recovery of the heart valve; the conical auxiliary cavity 46 is provided at the end of the airbag for gradually expanding the valve prosthesis when the valve prosthesis is expanded, thereby achieving a protective effect on the valve prosthesis, and also can preliminarily determine whether the position of the valve prosthesis is appropriate, thereby increasing the success rate of the operation, and at the same time, when retracting the valve prosthesis, the existence of the conical auxiliary cavity 46 can also achieve its rapid contraction.

[0040] The overall working process is as follows: the staff inserts the outer catheter 2 into the human body, inserts the inner catheter 3 and then inflates the inside of the bending balloon 41, and then bends the outer catheter 2 of the bending balloon 41. At this time, the inner catheter 3 and the outer catheter 2 are bent by pulling the inner catheter 3, thereby achieving control of the degree of catheter bending. After the bending angle and direction are controlled, it is only necessary to rotate the adjusting ring 12. The adjusting ring 12 rotates and drives the rotating gear 14 to rotate around the fixing column 13 through the adjusting tooth 16. The rotating gear 14 rotates and drives the spiral blades 15 to rotate. The spiral blades 15 rotate and shrink the inner hole formed by them, thereby achieving fixation of the inner catheter 3. After the operation is completed or the inner catheter 3 needs to be withdrawn, the adjusting ring 12 needs to be reversed. The rotating adjusting ring 12 drives the rotating gear 14 to flip, thereby flipping the spiral blades 15. At this time, the circular inner hole formed by the spiral blades 15 increases, and the staff pulls out the inner catheter 3.

[0041] The above shows and describes the basic principles, main features and advantages of the present invention. It should be understood by those skilled in the art that the present invention is not limited to the above embodiments. The above embodiments and descriptions are only for explaining the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, which fall within the scope of the present invention. The scope of protection of the present invention is defined by the attached claims and their equivalents.

Claims

1. An assembly method for valve prosthesis delivery, characterized in that: The following steps are involved: S1: providing a handle (5), a liquid catheter (6), an external catheter (2) and a liquid injection device (7), inserting the liquid catheter (6) into a designated position of the handle (5), connecting the liquid injection device (7) to the liquid catheter (6), and using the liquid injection device (7) to inject liquid into the catheter through the other end of the liquid catheter (6); S2: inserting the outer catheter (2) into the human body, inserting the inner catheter (3), and then inflating the interior of the bending airbag (41). After the bending airbag (41) is restarted, the inner catheter (3) is pulled to bend the outer catheter (2); S3: At this time, the adjusting ring (12) in the fixing mechanism (1) is rotated to make the spiral blades (15) close together and engage with the matching grooves (31) outside the inner catheter (3), thereby completing the fixing of the catheter; S4: At this time, the heart valve is inserted into the inner catheter (3) through the guide sheath, and the inner catheter (3) is extended to the designated position to complete the delivery of the valve prosthesis.

2. An assembly method for valve prosthesis delivery according to claim 1, characterized in that: The fixing mechanism (1) comprises a fixing ring (11), an adjusting ring (12), a fixing column (13), a rotating gear (14), a spiral blade (15) and an adjusting tooth (16); the fixing ring (11) is mounted on the handle (5); the adjusting ring (12) is mounted on the fixing ring (11); the fixing columns (13) are mounted in an annular array on the fixing ring (11); the rotating gear (14) is mounted on the fixing column (13); the spiral blade (15) is mounted on the rotating gear (14); and the adjusting ring (12) is mounted with an adjusting tooth (16) meshing with the rotating gear (14).

3. The assembly method for valve prosthesis delivery according to claim 2, characterized in that: The spiral blades (15) are in a semi-crescent shape, and the spiral blades (15) rotate in the same direction.

4. The assembly method for valve prosthesis delivery according to claim 3, characterized in that: An anti-slip gasket (17) is installed between the fixing ring (11) and the adjusting ring (12).

5. The assembly method for valve prosthesis delivery according to claim 4, characterized in that: The adjustment ring (12) is provided with anti-slip grooves (18).

6. The assembly method for valve prosthesis delivery according to claim 5, characterized in that: The end of the catheter is located on the handle (5) and is provided with a matching groove (31), and the matching groove (31) is used to engage with the spiral blade (15) so as to achieve better fixation of the catheter by the fixing mechanism (1).

7. An assembly method for valve prosthesis delivery according to claim 8, characterized in that: The end of the catheter is provided with a bending mechanism (4), the bending mechanism (4) comprising a bending airbag (41), an air hole (42) and an airway (43), the bending airbag (41) being provided at the end of the catheter and being in communication with the catheter, the bending airbag (41) being provided with an air hole (42), the catheter being provided with an airway (43), the air hole (42) being in communication with the airway (43).

8. An assembly method for valve prosthesis delivery according to claim 7, characterized in that: The bending airbag (41) is provided with a guide hole (44) for the valve prosthesis to pass through, and a fixing bracket (45) is installed on the top of the bending airbag (41), and the fixing bracket (45) is unfolded along with the unfolding of the bending airbag (41).

9. An assembly method for valve prosthesis delivery according to claim 8, characterized in that: The guide hole (44) is provided with a conical auxiliary cavity (46) for assisting the expansion and recovery of the heart valve at a position close to the end of the airbag.

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