An artificial heart valve delivery device and a delivery method

Abstract

The present invention belongs to the technical field of medical devices, and particularly relates to an artificial heart valve delivery device, which includes a housing, a mandrel, an outer sheath tube, a transfer rod, and a locking knob. The housing includes a first housing and a second housing. The transfer rod is installed between the second housing and the first housing. A transfer rod knob and a locking knob are installed on the second housing. The outer sheath tube is in transmission connection with the first housing. The mandrel passes through the outer sheath tube, the first housing, the transfer rod, and the second housing. The valve is loaded between the outer sheath tube and the mandrel. By rotating the transfer rod knob, the transfer rod moves along the second housing to release the valve. By rotating the locking knob, the mandrel slides into contact with the outer sheath tube to fix the mandrel, so as to realize the delivery of the valve. The structure of the present invention is simple and the operation is convenient, which reduces the operation requirements for doctors. At the same time, it has different adjustment speeds to meet the requirements of different stages of the operation and improve the operation efficiency.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to an artificial heart valve delivery device and a delivery method. Background Art

[0002] Heart valves include the mitral valve, tricuspid valve, aortic valve and pulmonary valve. Normal heart valves are important structures for maintaining the blood flow direction of the heart pump. Valve lesions such as stenosis and insufficiency will both lead to hemodynamic changes, causing a series of pathophysiological lesions, and endangering life in severe cases. There are many reasons for heart valve lesions, which are related to genetics, immunity, infection, etc., and also make heart valve disease one of the more common heart diseases.

[0003] Artificial heart valve replacement is currently the main means and the most effective way to treat heart valve diseases. During replacement, an interventional operation is required to deliver the artificial valve into the body. During the surgical process, it is necessary to use a delivery device to deliver the valve to the required position.

[0004] The valve delivery device generally includes a sheath tube that enters the body and a corresponding handle assembly to meet the requirements of valve delivery. During the operation, generally, the delivery device needs to have different delivery speeds to ensure the accuracy of delivery and the high efficiency of the operation. When releasing the valve, a controllable speed is required to ensure accurate positioning of the release. In the later stage of release and after complete release, it is necessary to quickly retract the delivery device to improve the efficiency of the operation.

[0005] Therefore, it is necessary to develop a delivery device with controllable delivery speed and high retraction efficiency to overcome the deficiencies in practical applications and meet the requirements of different stages of the operation. Summary of the Invention

[0006] Based on the above-mentioned drawbacks and deficiencies existing in the prior art, one of the purposes of the present invention is to at least solve one or more of the above problems existing in the prior art. In other words, one of the purposes of the present invention is to provide an artificial heart valve delivery device that meets one or more of the foregoing requirements.

[0007] The second purpose of the present invention is to provide an artificial heart valve delivery method that meets one or more of the foregoing requirements.

[0008] To achieve the above invention purposes, the present invention adopts the following technical solutions:

[0009] An artificial heart valve delivery device includes a housing, a mandrel, an outer sheath, a transfer rod, and a locking knob. The housing includes a first housing and a second housing. The transfer rod is installed between the second housing and the first housing. A transfer rod knob and a locking knob are installed on the second housing. The outer sheath is in driving connection with the first housing. The mandrel passes through the outer sheath, the first housing, the transfer rod, and the second housing. The valve is loaded between the outer sheath and the mandrel. By rotating the transfer rod knob, the transfer rod moves along the second housing to release the valve. By turning the locking knob, the mandrel slides into contact with the outer sheath to fix the mandrel and achieve the delivery of the valve.

[0010] As a preferred solution, the first housing is fixedly connected to the outer sheath. The outer sheath is a hollow structure, and a first boss is provided on the outer sheath.

[0011] As a preferred solution, a second boss is provided on the mandrel. The second boss is in snap-fit connection with the first boss. The second boss has a groove that cooperates with the valve.

[0012] As a preferred solution, a guiding structure is provided at one end of the mandrel, and a handle is installed at the other end of the mandrel. The guiding structure is in contact and cooperation with the outer sheath.

[0013] As a preferred solution, a first sleeve and a second sleeve are provided at the end of the outer sheath. The second sleeve is provided outside the first sleeve, and the length of the second sleeve is greater than that of the first sleeve.

[0014] As a preferred solution, the first sleeve is provided with a stepped hole. The inner diameter of the first sleeve is greater than the outer diameter of the outer sheath. The stepped hole is in contact and cooperation with the outer sheath.

[0015] As a preferred solution, the transfer rod knob is provided with a card slot. The card slot is in snap-fit connection with the second housing. The locking knob is in threaded connection with the second housing.

[0016] As a preferred solution, the first housing and the second housing are in threaded cooperation through the transfer rod.

[0017] As a preferred solution, the transfer rod is in threaded transmission with the transfer rod knob.

[0018] The present invention also provides an artificial heart valve delivery method, including the following steps:

[0019] (1) Compress and load the valve between the outer sheath and the mandrel;

[0020] (2) Send the mandrel and the outer sheath into the human body. After the implantation position is determined, rotate the transfer rod handle so that the transfer rod slides axially along the second housing to release the valve.

[0021] (3) After the valve is released, turn on the locking knob so that the mandrel contacts the outer sheath tube, and rotate the locking knob in the reverse direction to fix the mandrel to achieve valve delivery.

[0022] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0023] The present invention can be operated more simply, accurately and safely, reducing the operation requirements for medical practitioners. At the same time, it has different adjustment speeds to meet the requirements of different stages of the operation, improving the operation efficiency.

[0024] The delivery speed of the artificial heart valve delivery device of the present invention is controllable, the recovery efficiency is high, the operation is simple, and it can be reused. Description of the Drawings

[0025] Figure 1 is a schematic structural diagram of the delivery device according to Embodiment 1 of the present invention;

[0026] Figure 2 is a schematic cross-sectional view of the overall structure of the delivery device according to Embodiment 1 of the present invention;

[0027] Figure 3 is a schematic cross-sectional view of the mandrel according to Embodiment 1 of the present invention;

[0028] Figure 4 is a schematic cross-sectional view of the outer sheath tube assembly according to Embodiment 1 of the present invention;

[0029] Figure 5 is a schematic diagram of the first housing connection structure according to Embodiment 1 of the present invention;

[0030] Figure 6 is a schematic diagram of the second housing connection structure according to Embodiment 1 of the present invention;

[0031] Figure 7 is a schematic diagram of the notch on the first housing according to Embodiment 1 of the present invention;

[0032] Figure 8 is a schematic diagram of the locking state of the locking knob according to Embodiment 1 of the present invention;

[0033] In the figure: 1 inner mandrel assembly, 11 mandrel, 12 handle, 2 outer sheath tube assembly, 21 outer sheath tube, 22 first sleeve, 23 silicone gasket, 24 second sleeve, 3 housing, 31 first housing, 311 first knob, 312 upper piece of the first housing, 313 lower piece of the first housing, 314 second knob, 32 second housing, 321 upper piece of the second housing, 322 lower piece of the second housing, 323 tail knob, 4 adjustment assembly, 41 transfer rod, 42 transfer rod knob, 43 locking knob. Detailed Embodiments

[0034] To more clearly illustrate the embodiments of the present invention, the specific implementation manners of the present invention will be described below with reference to the accompanying drawings. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings, and other implementation manners can also be obtained.

[0035] Embodiment 1:

[0036] As Figures 1 to 2 shown, this embodiment provides an artificial heart valve delivery device, which includes an inner core shaft assembly 1, an outer sheath tube assembly 2, a housing 3, and an adjustment assembly 4. Among them, the inner core shaft assembly 1 includes a core shaft 11 and a handle 12, and the handle 12 is installed at the end of the core shaft. The outer sheath tube assembly 2 includes an outer sheath tube 21, the housing 3 includes a first housing 31 and a second housing 32, the adjustment assembly 4 includes a transfer rod 41, a transfer rod knob 42, and a locking knob 43. The locking knob 43 is threadedly connected to the second housing 32, the transfer rod 41 is in threaded transmission with the transfer rod knob 42, and the first housing 31 and the second housing 32 are in threaded cooperation through the transfer rod 41.

[0037] Specifically, the transfer rod 41 is installed between the second housing 32 and the first housing 31, the transfer rod knob 42 and the locking knob 43 are installed on the second housing 32, the outer sheath tube 21 is in transmission connection with the first housing 31, and the core shaft 11 passes through the outer sheath tube 21, the first housing 31, the transfer rod 41, and the second housing 32; the valve is loaded between the outer sheath tube 21 and the core shaft 11. By rotating the transfer rod knob 42, the transfer rod 41 moves along the second housing 32 to release the valve; by rotating the locking knob 43, the core shaft 11 slides into contact with the outer sheath tube 21 to fix the core shaft 11, so as to realize the delivery of the valve.

[0038] The first housing 31 is fixedly connected to the outer sheath tube 21. The outer sheath tube 21 is a hollow structure, and the outer sheath tube 21 is provided with a first boss. The core shaft 11 is provided with a second boss, and the second boss is in snap-fit connection with the first boss. The second boss has a groove, and the groove cooperates with the valve.

[0039] As Figure 3As shown in the figure, the inner mandrel assembly 1 includes two parts: a mandrel 11 and a handle 12. The top of the mandrel 11 is provided with a conical guiding structure, which can be a separate component or integrally connected to the mandrel 11. This structure facilitates the entry of the delivery device into the human body during the operation and plays a guiding role. The second boss structure is used to limit the position of the valve. Grooves and other structures can be provided on the second boss structure and cooperate with the valve, connecting to the tail structure of the valve to limit the circumferential movement of the valve. Among them, the groove shape can be set to different shapes such as I-shaped, T-shaped, or L-shaped. The second boss structure can also be a separate component and cooperate with the mandrel 11 to achieve this function. Among them, in order to observe and determine the position of the valve during the operation, the conical guiding structure and the second boss structure need to be added with imaging materials, which can be adding a certain content of barium sulfate and other materials for imaging in the overall material, or adding grooves or counterbores and cooperating with imaging rings or imaging points made of metal materials such as platinum or iridium to achieve this function. The end of the mandrel 11 is provided with a handle 12, which is convenient for operations such as grasping by hand during adjustment.

[0040] As Figure 4 shown, the outer sheath tube assembly 2 includes an outer sheath tube 21, a first sleeve 22, a silicone gasket 23, and a second sleeve 24. The inner diameter of the outer sheath tube 21 can be set to a single inner diameter or a variable inner diameter, and the specific inner diameter size can be any suitable value, depending on the diameter of the valve after compression. A first boss is provided at the rear section of the larger inner diameter cavity at the front end and cooperates with the second boss of the mandrel 11 to load the valve. Among them, the first boss part can also be a separate component, and a hole for cooperating with the mandrel 11 is provided inside the first boss, with a diameter larger than that of the mandrel 11 by 0.1 - 0.5 mm to ensure the fit.

[0041] The first sleeve 22 is sleeved at the tail end of the outer sheath tube 21 and is provided with a stepped hole inside. The inner diameter of the front end is larger than the outer diameter of the tail end of the outer sheath tube 21, and the stepped plane part contacts the tail of the outer sheath tube 21. The two can be connected by means of threads, adhesives, etc. The inner diameter of the rear end of the stepped hole cooperates with the mandrel 11, and the inner diameter of the stepped hole is larger than the inner diameter of the mandrel 11 and smaller than the outer diameter of the tail end of the outer sheath tube 21 to ensure the fit with the outer sheath tube.

[0042] The second sleeve 24 is sleeved outside the first sleeve 22 and is provided with a stepped hole inside. The inner diameter of the front end is larger than the outer diameter of the first sleeve 22, and the connection form between the two is not limited to threads or adhesives, etc. The inner diameter of the rear end of the stepped hole cooperates with the mandrel 11 and is slightly larger than the inner diameter of the mandrel 11. A silicone gasket 23 is placed between the first sleeve 22 and the second sleeve 24. The inner diameter of the silicone gasket 23 cooperates with the mandrel 11, and the outer diameter cooperates with the second sleeve 24 to ensure the sealing of the entire outer sheath tube 24. Among them, the outer sheath tube 21 and the first sleeve 22, and the first sleeve 22 and the second sleeve 24 are connected by means of adhesives or limiting rib grooves, etc. to ensure axial and circumferential fixation and move as a whole during adjustment.

[0043] AsFigure 5 As shown in Figure 5 , the first housing 31 includes a first knob 311, an upper first housing piece 312, a lower first housing piece 313, and a second knob 314. The interior of the first housing 31 has two parts of cavities. The front end is fitted with the outer sheath tube 21, and the rear end is fitted with the transfer rod 41. The mating shapes are not limited to cylindrical or stepped structures. A limiting groove and a limiting rib are provided at the mating structure to limit the circumferential movement between the two. The limiting structure can have one or more, and the shape is not limited to a groove and boss structure.

[0044] The first knob 311 and the second knob 314 respectively limit the connection between the upper first housing piece 312 and the lower first housing piece 313 and the transfer rod 41 or the outer sheath tube 21 at both ends. The knob structure can also be set as other structural parts. For example, a snap, an interference fit of a pin hole, or a threaded screw connection can be directly provided on the two-piece structure to achieve the connection. At the distal end in the axial direction of the silicone gasket 23, a through hole is provided and passes through the first housing 31, the second sleeve 24, and the first sleeve 22 in sequence. This through hole can be connected to the outer diameter of the evacuation tube and connected to the evacuation tube by means such as bonding, or it can be slightly smaller than the inner diameter of the evacuation tube. At this time, a boss needs to be added to the housing, and the outer diameter is fitted with the inner diameter of the evacuation tube, and the evacuation tube is connected by means such as bonding.

[0045] As Figure 6 shown in Figure 6 , the second housing 32 includes an upper second housing piece 321, a lower second housing piece 322, and a tail knob 323. The transfer rod knob 42 is provided with a card slot, and the card slot is engaged with the second housing 32 for axial fixation. However, the circumferential connection is rotatable, and the connection can be but is not limited to a snap connection. The interior of the second housing 32 has a cavity for accommodating the transfer rod 41 during transmission. Among them, the length of the cavity is greater than the transmission distance to ensure that the transmission can be completed. The minimum inner diameter of the cavity is greater than the maximum outer diameter of the transfer rod to ensure that the transfer rod 41 can be received inside the cavity. A guiding groove or a limiting strip is provided inside the cavity and is engaged with the groove on the transfer rod 41 to limit the circumferential movement of the transfer rod 41. When the transfer rod knob 42 is rotated, the transfer rod 41 can only move forward or backward axially, ensuring the safety and efficiency of valve release.

[0046] The tail end of the second housing 32 is provided with a tail end knob 323 for connecting and fixing the upper second housing piece 321 and the lower second housing piece 322. The tail end of the second housing 32 is connected to the locking knob 43. Among them, the locking knob 43 has a tapered hole inside, which is engaged with the tapered structure at the tail end of the second housing 32 for locking the mandrel 11. The mating taper can be the same slope, or the slope of the tapered hole can be selected to be smaller than the tapered structure at the tail end of the second housing 32.

[0047] As Figure 7As shown, the conical structure at the tail of the second housing 32 is circumferentially provided with notches, and the number of notches can be two or more to ensure a certain circumferential deformation of the conical structure. The proximal part of the tail knob 323 that cooperates with the locking knob 43 can be provided with symbol descriptions such as scale lines for indicating whether it is in the locked state or the unlocked state at this time.

[0048] As Figure 8 shown, when in the locked state, the slope of the conical hole of the locking knob 43 is smaller than the conical structure at the tail end of the second housing 32. When the knob is rotated forward, the conical hole gradually contacts and interferes with the conical structure at the tail end, and the conical structure at the tail end with notches will deform, thereby pressing the central mandrel 11 part, so as to lock the mandrel 11 and restrict the circumferential rotation and axial movement of the mandrel 11.

[0049] In the initial state, the valve is compressed into the inner side of the outer sheath tube and loaded in cooperation with the mandrel 11. At this time, the locking knob 43 is in the locked state, and the mandrel 11 is fixed and connected to the second housing 32. During the operation, the mandrel 11 and the outer sheath tube 21 are sent into the human body. When the implantation position is determined through imaging, the transfer rod knob 42 is rotated clockwise. At this time, the cooperating transfer rod 41 will slide axially backward, and the valve will be slowly exposed. As the backward movement distance increases, more and more of the valve is released until it is completely exposed by the groove part of the mandrel 11 and can pop out to reach complete release. When the valve is completely released, the locking knob 43 can be opened. At this time, hold the second housing 32 with one hand and pull the handle 12 on the mandrel 11 backward with the other hand. At this time, the mandrel 11 slides quickly until the conical structure on the mandrel 11 contacts the outer sheath tube 21, and the locking knob 43 is rotated in the reverse direction to fix the mandrel 11. Finally, the entire delivery device is retrieved outside the human body.

[0050] The mandrel 11 quickly retracts to contact the outer sheath tube 21, which can avoid that when the entire delivery device retracts, there is still a part of the mandrel 11 that has not retracted after the outer sheath tube 21 has withdrawn. At this time, the diameter difference of the conical structure part of the mandrel 11 is relatively large, which may cause secondary damage. In addition, the quick retraction can also reduce the overall retraction time and increase the surgical efficiency.

[0051] Another quick retraction method may also be used to release the valve during the operation. If the length of the valve is relatively long and it has been partially released, the locking knob 43 can be opened. At this time, fix the handle of the mandrel 11 and pull the second housing 32 to drive the transmission outer sheath tube 21 to quickly retract to release the valve stent. This method can accelerate the valve release speed and improve the surgical efficiency.

[0052] Correspondingly, this embodiment also provides a method for delivering an artificial heart valve, including the following steps:

[0053] (1) Compress the valve to the inside of the outer sheath tube and load it in cooperation with the mandrel;

[0054] (2) Send the mandrel and the outer sheath tube into the human body. After the implantation position is determined, rotate the handle of the transfer rod so that the transfer rod slides axially along the second housing to release the valve;

[0055] (3) After the valve is released, open the locking knob so that the mandrel contacts the outer sheath tube, and rotate the locking knob in the reverse direction to fix the mandrel to realize the delivery of the valve.

[0056] The above is only a detailed description of the preferred embodiments and principles of the present invention. For those of ordinary skill in the art, according to the idea provided by the present invention, there will be changes in the specific implementation manners, and these changes should also be regarded as the protection scope of the present invention.

Claims

1. An artificial heart valve delivery device, characterized in that, It includes a housing, a mandrel, an outer sheath tube, a transmission rod and a locking knob. The housing includes a first housing and a second housing. The transmission rod is installed between the second housing and the first housing. The transmission rod knob and the locking knob are installed on the second housing. The outer sheath tube is in transmission connection with the first housing. The mandrel passes through the outer sheath tube, the first housing, the transmission rod and the second housing. The transmission rod is in threaded transmission with the transmission rod knob. The first housing is fixedly connected to the outer sheath tube. The outer sheath tube is a hollow structure and is provided with a first boss thereon. The end of the outer sheath tube is provided with a first sleeve and a second sleeve. The second sleeve is arranged outside the first sleeve, and the length of the second sleeve is greater than that of the first sleeve. The tail end of the second housing is provided with a tail end knob for connecting and fixing the upper piece and the lower piece of the second housing. The tail end of the second housing is connected to the locking knob. The locking knob is in threaded connection with the second housing. Among them, a tapered hole is provided inside the locking knob, which is matched with the tapered structure at the tail end of the second housing for locking the mandrel. The slope of the tapered hole of the locking knob is smaller than the tapered structure at the tail end of the second housing. The valve is loaded between the outer sheath tube and the mandrel. When the locking knob is in the locked state, the mandrel is fixed and connected to the second housing. By rotating the transmission rod knob, the transmission rod is retracted along the second housing to release the valve. When the valve is completely released, the locking knob is rotated to open, and the mandrel quickly slides to contact the outer sheath tube. The locking knob is rotated in the reverse direction to fix the mandrel. Finally, the entire delivery device is retrieved outside the human body.

2. The artificial heart valve delivery device according to claim 1, characterized in that, One end of the mandrel is provided with a guiding structure, and a handle is installed at the other end of the mandrel. The guiding structure is in contact and cooperation with the outer sheath tube.

3. The artificial heart valve delivery device according to claim 1, characterized in that, The first sleeve is provided with a stepped hole. The inner diameter of the first sleeve is greater than the outer diameter of the outer sheath tube. The stepped hole is in contact and cooperation with the outer sheath tube.

4. The artificial heart valve delivery device according to claim 1, characterized in that, The transmission rod knob is provided with a clamping groove, and the clamping groove is in clamping cooperation with the second housing.

5. The artificial heart valve delivery device according to claim 1, characterized in that, The first housing and the second housing are in threaded cooperation through the transmission rod.

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