Push-button type artificial valve delivery device and delivery method

Abstract

The present invention belongs to the technical field of medical devices, and specifically relates to a push-button type artificial valve delivery device, comprising a core shaft, an outer sheath, a screw, a first handle and a second handle, wherein the screw is installed between the first handle and the second handle, the outer sheath is fixedly connected to the first handle, the core shaft is passed through the outer sheath, the first handle and the second handle, the valve is loaded between the core shaft and the outer sheath, and a knob, a connecting tube and a push-button assembly are installed on the second handle. By rotating the knob, the screw drives the first handle and the outer sheath to move proximally to achieve positioning of the valve; by pressing the push-button assembly and pulling it proximally, the connecting tube drives the screw to move, and links the first handle and the outer sheath to move proximally to achieve release of the valve; the present invention is easy to operate and stable in operation, and can achieve precise positioning and rapid release of the artificial valve.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a push-button type artificial valve delivery device and a delivery method. Background Art

[0002] Heart valves are valves between the atria and ventricles, or between the ventricles and arteries. They play a key role in the heart's constant circulation of blood. Everyone has four valves in their heart: the aortic valve, which connects the left ventricle to the aorta; the pulmonary valve, which connects the right ventricle to the pulmonary artery; the mitral valve, which connects the left atrium to the left ventricle; and the tricuspid valve, which connects the right atrium to the right ventricle. Each valve acts as a one-way valve, preventing blood from flowing in one direction but not in the opposite direction.

[0003] Valvular heart disease is a common heart disease. Its main clinical manifestation is that the mitral valve, tricuspid valve, aortic valve and pulmonary valve develop lesions due to rheumatic fever, myxomatous degeneration, degenerative changes, congenital malformations, ischemic necrosis, infection or trauma, which affect the normal flow of blood, thereby causing abnormal heart function and ultimately leading to single-valve or multi-valve lesions of heart failure.

[0004] Heart valve repair or replacement under extracorporeal circulation is the standard treatment for heart valve disease. However, elderly patients or those with underlying diseases cannot tolerate such major surgery. In the past 10 years, transcatheter artificial valve replacement has gradually become a new treatment method. Compared with traditional surgical treatment, transcatheter mitral valve replacement has the advantages of not requiring open chest surgery, less trauma, and faster patient recovery, making it more suitable for elderly patients and patients with underlying diseases.

[0005] Transcatheter heart valve replacement primarily involves delivering the heart valve to the affected area using a delivery device. During the procedure, the delivery device typically requires varying speeds to achieve precise positioning and rapid release. Existing delivery devices often fail to achieve both precise positioning and rapid release, and are complex and require numerous components. Therefore, improvements are needed to overcome these limitations in practical applications. Summary of the Invention

[0006] Based on the above-mentioned shortcomings and deficiencies in the prior art, one of the objects of the present invention is to at least solve one or more of the above-mentioned problems in the prior art. In other words, one of the objects of the present invention is to provide a push-button type artificial valve delivery device and delivery method that meets one or more of the above-mentioned needs.

[0007] In order to achieve the above-mentioned object of the invention, the present invention adopts the following technical solutions:

[0008] A push-button type artificial valve delivery device includes a core shaft, an outer sheath, a screw, a first handle and a second handle. The screw is installed between the first handle and the second handle. The outer sheath is fixedly connected to the first handle. The core shaft is passed through the outer sheath, the first handle and the second handle. The valve is loaded between the core shaft and the outer sheath. A knob, a connecting tube and a push-button assembly are installed on the second handle. By turning the knob, the screw drives the first handle and the outer sheath to move toward the proximal end to achieve positioning of the valve; by pressing the push-button assembly and pulling it toward the proximal end, the connecting tube drives the screw to move, and links the first handle and the outer sheath to move toward the proximal end to achieve release of the valve.

[0009] As a preferred solution, a first sleeve and a second sleeve are provided in the first handle, and the inner diameter of the first sleeve is greater than the outer diameter of the second sleeve.

[0010] As a preferred solution, a stepped hole is provided in the second sleeve, and the stepped hole is fixedly connected to the end of the outer sheath tube.

[0011] As a preferred solution, the screw rod is threadably matched with the knob.

[0012] As a preferred solution, the knob is provided with a latching tooth, and the connecting tube is provided with a latching groove, and the latching groove is engaged with the latching tooth.

[0013] As a preferred solution, the button assembly includes a button cover, a button base, a spring, and a limiting tube. The button base is provided with a through hole, the button cover is snap-fitted with the button base, the limiting tube passes through the through hole and is fixedly connected to the button cover, and the spring is installed between the limiting tube and the button base.

[0014] As a preferred solution, the connecting tube is provided with a first protrusion structure and a second protrusion structure, the second handle is provided with a first slide groove, the first slide groove is slidably matched with the first protrusion structure, the inner diameter of the limiting tube is larger than the outer diameter of the second protrusion structure, and the limiting tube is sleeved outside the second protrusion structure.

[0015] As a preferred solution, the second handle is provided with an open slot, the width of the open slot is greater than the diameter of the limiting tube, and the limiting tube is in sliding fit with the open slot.

[0016] As a preferred solution, the limiting tube is provided with a limiting structure, and the second handle is provided with a limiting groove, and the limiting structure and the limiting groove are movably matched; when the limiting structure is located in the limiting groove, the pressing button assembly is fixed to the second handle; when the limiting structure is separated from the limiting groove, the pressing button assembly and the second handle are slidingly matched.

[0017] The present invention also provides a push-button type artificial valve delivery method, comprising the following steps:

[0018] (1) Loading the artificial valve between the core shaft and the outer sheath;

[0019] (2) advancing the core shaft and outer sheath to the implantation site for pre-positioning;

[0020] (3) Slowly release the artificial valve by rotating the knob and adjust the release position of the artificial valve at the same time;

[0021] (4) After the release position is determined, press the button assembly and pull it toward the proximal end to complete the rapid release of the artificial valve.

[0022] Compared with the prior art, the present invention has the following beneficial effects:

[0023] The push-button artificial valve delivery device of the present invention is easy to operate and runs stably. The combination of knob transmission and push-button transmission can achieve precise positioning and rapid release of the artificial valve.

[0024] The push-button artificial valve delivery device of the present invention has a simple structure, few parts, and is easy to install, thereby reducing production costs and installation time and improving efficiency.

[0025] The push-button type artificial valve delivery device of the present invention has a wide transmission stroke range and is applicable to artificial valves of different lengths. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 This is a schematic diagram of the overall structural connection of the conveying device according to the first embodiment of the present invention;

[0027] Figure 2 1 is a schematic cross-sectional view of the overall structure of the conveying device according to the first embodiment of the present invention;

[0028] Figure 3 is a cross-sectional schematic diagram of a first handle according to a first embodiment of the present invention;

[0029] Figure 4 This is an exploded schematic diagram of the first handle of the first embodiment of the present invention;

[0030] Figure 5 1 is a schematic diagram of the screw connection of the first embodiment of the present invention;

[0031] Figure 6 This is a schematic diagram of the cooperation between the knob and the connecting tube in the first embodiment of the present invention;

[0032] Figure 7 This is a schematic diagram of the connecting pipe structure of the first embodiment of the present invention;

[0033] Figure 8 This is a schematic structural diagram of a second handle according to the first embodiment of the present invention;

[0034] Figure 9 This is a schematic diagram of the first mounting portion of the second housing according to the first embodiment of the present invention;

[0035] Figure 101 is a cross-sectional schematic diagram of the push button assembly in the restricted state according to the first embodiment of the present invention;

[0036] Figure 11 1 is a cross-sectional schematic diagram of the push button assembly in the first embodiment of the present invention in a disengaged state;

[0037] In the figure: 1 sheath core assembly, 11 core shaft, 12 outer sheath, 2 first handle, 21 first housing first mounting portion, 211 first limiting rib, 212 second limiting rib, 213 housing exhaust hole, 214 first handle thread, 215 sleeve limiting rib, 216 screw limiting rib, 22 first housing second mounting portion, 23 first sleeve, 231 first sleeve exhaust hole, 232 sleeve limiting groove, 24 second sleeve, 241 second sleeve exhaust hole, 242 step hole, 25 sealing gasket, 26 threaded cover, 3 knob assembly, 31 screw, 311 screw thread, 312 first end face, 3121 screw limiting groove, 313 second end face, 32 knob, 321 screw Button thread, 322 knob teeth, 33 connecting tube, 331 connecting tube slot, 332 assembly notch, 333 first protrusion structure, 334 second protrusion structure, 4 push button assembly, 41 push button cover, 411 push button cover teeth, 42 spring, 43 push button base, 431 base slide, 432 base slot, 433 base through hole, 44 limiting tube, 441 limiting structure, 442 top, 5 second handle, 51 second shell, 511 second shell first mounting part, 5111 first sliding groove, 5112 opening groove, 5113 limiting groove, 5114 push button sliding groove, 512 second shell second mounting part, 513 second handle tail thread, 52 locking knob. DETAILED DESCRIPTION

[0038] To more clearly illustrate the embodiments of the present invention, specific embodiments of the present invention will be described below with reference to the accompanying drawings. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings and other embodiments can be obtained based on these drawings without inventive efforts.

[0039] Example 1:

[0040] like Figures 1 to 2 As shown, this embodiment provides a push-button artificial valve delivery device, including a sheath-core assembly 1, a first handle 2, a knob assembly 3, a push-button assembly 4, and a second handle 5. The sheath-core assembly 1 includes a core shaft 11 and an outer sheath tube 12, the first handle 2 includes a first housing first mounting portion 21, a first housing second mounting portion 22, a first sleeve 23, a second sleeve 24, a sealing gasket 25, and a threaded cap 26, the knob assembly 3 includes a screw 31, a knob 32, and a connecting tube 33, and the second handle 5 includes a second housing 51 and a locking knob 52.

[0041] Specifically, the core shaft 11 is inserted into the outer sheath 12 , the first handle 2 , the knob assembly 3 , and the second handle 5 . The outer sheath 12 and the second sleeve 24 are fixedly connected to the inside of the first handle 2, and the first handle 2 and the knob 32 are connected by a screw 31. The first end face 312 of the screw 31 is fixedly connected to the first handle 2, and a screw thread 311 is provided on the screw 31, and the screw thread 311 can be matched with the knob thread 321. When the knob 32 is rotated, the screw 31 drives the first handle 2 and the outer sheath 12 to move from the distal end to the proximal end. The knob 32 and the connecting tube 33 are connected by a snap buckle, and the knob 32 can rotate relative to the connecting tube 33; the connecting tube 33 is sleeved in the second handle 5, and the connecting tube 33 can slide relative to the second handle 5; the connecting tube 33 is provided with a second protrusion structure 334, and the pressing button assembly 4 is a hollow structure and is sleeved on the second protrusion mechanism 334; one end of the second handle 5 is provided with a second handle tail thread 513, and the second handle tail thread 513 can be matched with the locking knob 52.

[0042] like Figures 3 and 4 As shown, the first handle 2 includes a first housing first mounting portion 21, a first housing second mounting portion 22, a first sleeve 23, a second sleeve 24, a sealing gasket 25, and a threaded cover 26. Stoppers are provided at the edges of the first housing first mounting portion 21 and the first housing second mounting portion 22 to facilitate assembly.

[0043] A first handle thread 214 is respectively provided at one end of the first mounting portion 21 of the first shell and the second mounting portion 22 of the first shell. The first handle thread 214 can cooperate with the thread inside the thread cover 26. By tightening the thread cover 26, the first mounting portion 21 of the first shell and the second mounting portion 22 of the first shell can be assembled.

[0044] The outer diameter of the second sleeve 24 is smaller than the inner diameter of the first sleeve 23, and the length of the second sleeve 24 is smaller than the length of the first sleeve 23. The first sleeve 23 can be sleeved outside the second sleeve 24, and a sealing gasket 25 is placed between the first sleeve 23 and the second sleeve 24 to prevent blood from passing during operation.

[0045] A stepped hole 242 is provided in the second sleeve 24 , and the stepped hole 242 can be connected with one end of the outer sheath tube 12 . The connection method can be mechanical connection or glue connection, and the firmness and sealing of the connection must be ensured.

[0046] The first sleeve 23 can be embedded in the first limiting rib 211 and the second limiting rib 212. The first sleeve 23 is provided with limiting grooves 232 on both sides. The limiting grooves 232 can be matched and connected with the sleeve limiting ribs 215 in the first handle shell 21 to realize the fixation of the first sleeve 23 inside the first handle 2. The first mounting part 21 of the first handle shell, the first sleeve 23, and the second sleeve 24 are respectively provided with coaxially arranged shell exhaust holes 213, first sleeve exhaust holes 231 and second sleeve exhaust holes 241, which serve to discharge the air in the first handle 1.

[0047] like Figure 5 As shown, the first end face 312 of the screw 31 is a conical structure and is provided with a screw limiting groove 3121. The conical structure can cooperate with the internal shape of the first handle 2, and the screw limiting groove 3121 can cooperate with the screw limiting rib 216 inside the first mounting portion 21 of the first shell, thereby realizing the axial and circumferential fixation of the screw 31 relative to the first handle 2. The screw 31 is provided with a screw thread 311, which can be designed as a single-line or double-line thread according to actual needs. The second end face 313 of the screw 31 is cylindrical.

[0048] like Figures 6 and 7 As shown, one end of the knob 32 is provided with a knob thread 321, and the knob thread 321 and the screw thread 311 can cooperate with each other. When the knob 32 is rotated, the screw 31 can drive the first handle 2 and the outer sheath 12 to move from the distal end to the proximal end. To prevent the screw 31 and the knob 32 from detaching during use, the outer diameter of the second end face 313 of the screw 31 should be larger than the minimum inner diameter of the knob thread 321. The knob 32 and the connecting tube 33 are connected through the cooperation of the knob tooth 322 and the connecting tube slot 331. This connection method includes but is not limited to a snap connection to achieve axial fixation of the knob 32 and the connecting tube 33, and a circumferentially rotatable connection method. One end of the connecting tube 33 can be provided with an assembly notch 332 to facilitate assembly.

[0049] like Figures 7 and 8As shown, a first protrusion structure 333 and a second protrusion structure 334 are provided on the connecting tube 33, and the first protrusion structure 333 is arranged on both sides and the bottom of the limiting tube. A first slide groove 5111 is provided on both sides and the bottom of the inner wall of the second handle 5. The first protrusion structure 333 can be embedded in the first slide groove 5111 to realize the circumferential fixation and axial movement of the connecting tube 33 relative to the second handle 5. The second shell 51 is spliced ​​by the first mounting portion 511 of the second shell and the second mounting portion 512 of the second shell. A second handle tail thread 513 is provided at the tail of the second handle 5, and the second handle tail thread 513 can cooperate with the locking knob 52. When the locking knob 52 is tightened, the first mounting portion 511 of the second shell and the second mounting portion 512 of the second shell can be assembled. As an alternative, the first mounting portion 511 of the second shell and the second mounting portion 512 of the second shell can also be connected by bonding, snapping or welding.

[0050] The push button assembly 4 consists of a push button cover 41, a spring 42, a push button base 43 and a limiting tube 44. The inner diameter of the limiting tube 44 is larger than the outer diameter of the second protrusion structure 334 of the connecting tube 33. The limiting tube 44 is sleeved outside the second protrusion structure 334. A base through hole 433 is provided in the middle of the push button base 43. The limiting tube 44 can pass through the base through hole 433. The top end 442 of the limiting tube is fixedly connected to the push button cover 41. The connection method includes but is not limited to adhesive connection or snap connection.

[0051] Among them, the button cover 41 and the button base 43 are connected by the button cover teeth 411 and the base slot 432, and the spring 42 is placed between the inner wall of the button cover 41 and the outer wall of the limiting tube 44. The top surface of the first mounting part 511 of the second shell is provided with an open groove 5112, and the limiting tube 44 can pass through the open groove 5112, so that one end of the limiting tube 44 is located inside the second handle 5, and the other end is located outside the second handle 5.

[0052] A base slide 431 is provided at the bottom of the button base 43, and the base slide 431 can slide axially along the button sliding groove 5114 of the first mounting part 511 of the second shell. A limiting groove 5113 is also provided inside the first mounting part 511 of the second shell. The shape of the limiting groove 5113 should be the same as the limiting structure 441 of the limiting tube 44, and a certain gap should be left between the two so that the limiting structure 441 can be embedded in the limiting groove 5113.

[0053] like Figure 9As shown, the limiting groove 5113 is located inside the first mounting portion 511 of the second shell and on both sides of the opening groove 5112. In order to facilitate the limiting structure 441 of the limiting tube 44 to be embedded in the limiting groove 5113, the inside of the limiting groove 5113 can be chamfered. The upper half of the first slide groove 5111 is provided on both sides of the first mounting portion 511 of the second shell, and the lower half of the first slide groove 5111 is provided on both sides of the second mounting portion 512 of the second shell. By splicing the first mounting portion 511 of the second shell and the second mounting portion 512 of the second shell, a complete first slide groove 5111 is formed; the tail thread 513 of the second handle 5 is grooved. When tightened using the locking screw 52, ​​a circumferential inward pre-tightening force will be generated at the tail thread 513, thereby locking the axial movement of the core shaft 11.

[0054] like Figure 10 As shown, the second shell 51 is spliced ​​by the second shell first mounting part 511 and the second shell second mounting part 512, and the first protrusion structure 333 of the connecting tube 33 is embedded in the first sliding groove 5111. The connecting tube 33 can slide axially relative to the second handle 5, but cannot rotate circumferentially.

[0055] The limiting tube 44 is sleeved on the outside of the second protruding structure 334 of the connecting tube 33, and the limiting tube 44 can slide up and down relative to the second protruding structure 334; the limiting structure 441 of the limiting tube 44 is located in the limiting groove 5113 in the second handle 5, and the top of the limiting tube 44 passes through the opening groove 5112 and the base through hole 433 and is fixedly connected to the push button cover 41; when the push button cover 41 is not subjected to pressing pressure, due to the upward pre-tightening force generated by the spring 42, the limiting structure 441 of the limiting tube 44 is located in the limiting groove 5113, and through the constraint of the limiting groove 5113, the push button assembly 4 cannot move axially relative to the second handle 5.

[0056] like Figure 11 As shown, when downward pressure is applied to the button cover 41, the spring 42 is compressed, the button cover 41 moves downward, and drives the limiting structure 441 of the limiting tube 44 to move downward. At this time, the limiting structure 441 disengages from the limiting groove 5113; when downward pressure and backward pulling force are applied to the button cover 41 at the same time, the button assembly 4 drives the connecting tube 33, the connecting tube 33 drives the knob 32, the knob 32 drives the screw 31, the screw 31 drives the first handle 2, and the first handle 2 drives the outer sheath 12 to move from the distal end to the proximal end; since the core shaft 11 is locked and fixed by the locking knob 52, the outer sheath 12 moves backward relative to the core shaft 11, thereby completing the rapid release of the valve.

[0057] When the limiting structure 441 of the limiting tube 44 is located in the limiting groove 5113, the outer sheath 12, the front handle 2, and the screw 31 can only be moved slowly from the distal end to the proximal end by rotating the knob 32. In this process, the release position of the artificial valve can be accurately positioned; when the release position is determined, press and pull the push button assembly 4 backward. At this time, the limiting structure 441 disengages from the limiting groove 5113, and the push button assembly 4 drives the connecting tube 33, the connecting tube 33 drives the knob 32, the knob 32 drives the screw 31, the screw 31 drives the first handle 2, and the first handle 2 drives the outer sheath 12 to move quickly from the distal end to the proximal end to achieve rapid release.

[0058] Accordingly, this embodiment further provides a push-button artificial valve delivery method, which specifically includes the following steps:

[0059] (1) Loading the artificial valve between the core shaft and the outer sheath;

[0060] (2) advancing the core shaft and outer sheath to the implantation site for pre-positioning;

[0061] (3) Slowly release the artificial valve by rotating the knob and adjust the release position of the artificial valve at the same time;

[0062] (4) After the release position is determined, press the button assembly and pull it toward the proximal end to complete the rapid release of the artificial valve, thereby achieving accurate positioning of the artificial valve.

[0063] The above description is only a detailed description of the preferred embodiments and principles of the present invention. For ordinary technicians in this field, based on the ideas provided by the present invention, there may be changes in the specific implementation methods, and these changes should also be considered as the scope of protection of the present invention.

Claims

1. A push-button artificial valve delivery device, characterized in that: The valve comprises a core shaft, an outer sheath, a screw, a first handle and a second handle, wherein the screw is installed between the first handle and the second handle, the outer sheath is fixedly connected to the first handle, the core shaft is passed through the outer sheath, the first handle and the second handle, the artificial valve is loaded between the core shaft and the outer sheath, a knob, a connecting tube and a pressing button assembly are installed on the second handle, and the screw is threadedly matched with the knob; The knob is provided with a latching tooth, and the connecting tube is provided with a latching groove, and the latching groove and the latching tooth are engaged with each other to realize the connection mode in which the knob and the connecting tube are fixed in the axial direction and can rotate in the circumferential direction; The push button assembly includes a push button cover, a push button base, a spring and a limit tube. The push button base is provided with a through hole. The push button cover is engaged with the push button base. The limit tube passes through the through hole and is fixedly connected to the push button cover. The spring is installed between the inner wall of the push button cover and the outer wall of the limit tube. The connecting tube is provided with a first protrusion structure and a second protrusion structure, and the second handle is provided with a first slide groove, and the first slide groove and the first protrusion structure are slidably matched to realize the circumferential fixation and axial movement of the connecting tube relative to the second handle, the inner diameter of the limiting tube is larger than the outer diameter of the second protrusion structure, and is sleeved outside the second protrusion structure and can slide up and down relative to the second protrusion structure, and the second handle is provided with an open groove, the width of the open groove is larger than the diameter of the limiting tube, and the limiting tube and the open groove are slidably matched; when the button cover is not subjected to pressing pressure, the spring generates an upward pre-tightening force, and the limiting structure of the limiting tube is located at the limiting position in the second handle. In the groove, due to the constraint of the limit groove, the push button assembly cannot move axially relative to the second handle, and can only move the first handle and the outer sheath tube proximally by turning the knob to position the artificial valve; when the release position is determined, press and pull the push button cover backward. At this time, the limiting structure disengages from the limit groove, and the push button assembly drives the connecting tube, the connecting tube drives the knob, and the knob drives the screw to move, and the first handle and the outer sheath tube move proximally in conjunction. Since the core shaft is locked and fixed by the locking knob of the second handle, the outer sheath tube moves proximally relative to the core shaft, thereby completing the rapid release of the artificial valve.

2. A push-button artificial valve delivery device according to claim 1, characterized in that: A first sleeve and a second sleeve are provided in the first handle, and the inner diameter of the first sleeve is greater than the outer diameter of the second sleeve.

3. The push-button artificial valve delivery device according to claim 2, characterized in that: A stepped hole is provided in the second sleeve, and the stepped hole is fixedly connected to the end of the outer sheath tube.

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