CN112472366A - Artificial heart valve conveying device and conveying method - Google Patents

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a prosthetic heart valve conveying device which comprises a shell, a mandrel, an outer sheath tube, a transmission rod and a locking knob, wherein the shell comprises a first shell and a second shell, the transmission rod is arranged between the second shell and the first shell, the transmission rod knob and the locking knob are arranged on the second shell, the outer sheath tube is in transmission connection with the first shell, and the mandrel is arranged in the outer sheath tube, the first shell, the transmission rod and the second shell in a penetrating manner; the valve is loaded between the sheath tube and the mandrel, and the transmission rod moves along the second shell by rotating the transmission rod knob so as to release the valve; rotating the locking knob, and sliding the mandrel to be in contact with the outer sheath tube so as to fix the mandrel and realize the delivery of the valve; the invention has simple structure and convenient operation, reduces the operation requirements of doctors, has different adjustment speeds, can meet the requirements of different stages of the operation and improves the operation efficiency.

Description

Artificial heart valve conveying device and conveying method

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a conveying device and a conveying method for a prosthetic heart valve.

Background

Heart valves include the mitral, tricuspid, aortic, and pulmonary valves. The normal heart valve is an important structure for maintaining the blood flow of the heart pump. Valvular pathologies such as stenosis and incompetence can lead to hemodynamic changes, leading to a series of pathophysiological pathologies, which are life-threatening in the severe cases. The heart valve diseases are caused by a plurality of reasons, are related to heredity, immunity, infection and the like, and are one of the more common heart diseases.

Prosthetic heart valve replacement is currently the primary means and most effective approach for treating heart valve disease, requiring interventional procedures to deliver the prosthetic valve into the body at the time of replacement. During the course of the surgery, it is necessary to deliver the valve to the desired location by means of a delivery device.

Valve delivery devices typically include a sheath that enters the body and a corresponding handle assembly to accomplish the delivery requirements of the valve. In the operation process, the conveyor is generally required to have different speed conveying speeds to ensure the conveying accuracy and the high efficiency of the operation, the controllable speed is required to ensure the accurate positioning of the release when the valve is released, and the conveying device is required to be quickly retracted to improve the efficiency of the operation at the later release stage and after the valve is completely released.

Therefore, a conveying device with controllable conveying speed and high recovery efficiency needs to be developed to overcome the defects in practical application and meet the requirements of different stages of the operation.

Disclosure of Invention

Based on the above-mentioned shortcomings and drawbacks of the prior art, it is an object of the present invention to at least address one or more of the above-mentioned problems of the prior art, in other words, to provide a prosthetic heart valve delivery device that meets one or more of the above-mentioned needs.

It is another object of the present invention to provide a method of delivering a prosthetic heart valve that meets one or more of the aforementioned needs.

In order to achieve the purpose, the invention adopts the following technical scheme:

a kind of artificial heart valve conveying appliance, including body, dabber, exterior sheath pipe, transfer lever and locking knob, the body includes the first body and second body, mount the transfer lever between first body and the second body, mount transfer lever knob and locking knob on the second body, the exterior sheath pipe is connected with first body transmission, the dabber is worn and set up in exterior sheath pipe, first body, transfer lever and second body; the valve is loaded between the sheath tube and the mandrel, and the transmission rod moves along the second shell by rotating the transmission rod knob so as to release the valve; and when the locking knob is rotated, the mandrel slides to be in contact with the outer sheath tube so as to fix the mandrel, so that the valve is conveyed.

Preferably, the first housing is fixedly connected with an outer sheath tube, the outer sheath tube is of a hollow structure, and a first boss is arranged on the outer sheath tube.

Preferably, a second boss is arranged on the mandrel and is in clamping fit with the first boss, and the second boss is provided with a groove which is matched with the valve.

As the preferred scheme, one end of the mandrel is provided with a guide structure, the other end of the mandrel is provided with a handle, and the guide structure is in contact fit with the outer sheath tube.

Preferably, the end of the outer sheath 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.

Preferably, the first sleeve is provided with a stepped hole, the inner diameter of the first sleeve is larger than the outer diameter of the outer sheath, and the stepped hole is in contact fit with the outer sheath.

As the preferred scheme, the transfer rod knob is provided with a clamping groove, the clamping groove is in clamping fit with the second shell, and the locking knob is in threaded connection with the second shell.

Preferably, the first housing and the second housing are in threaded fit through a transfer rod.

Preferably, the transmission rod is in threaded transmission with a transmission rod knob.

The invention also provides a method for delivering the artificial heart valve, which comprises the following steps:

(1) compressing and loading the valve between the sheath tube and the mandrel;

(2) the mandrel and the outer sheath tube are sent into a human body, and after the implantation position is determined, the handle of the transmission rod is rotated to enable the transmission rod to slide along the axial direction of the second shell so as to release the valve;

(3) when the valve is released, the locking knob is opened to enable the mandrel to be in contact with the outer sheath, and the locking knob is rotated reversely to fix the mandrel so as to realize valve delivery.

Compared with the prior art, the invention has the beneficial effects that:

the invention can be operated more simply, accurately and safely, reduces the operation requirements of a doctor, has different adjustment speeds, can meet the requirements of different stages of the operation and improves the operation efficiency.

The artificial heart valve delivery device has the advantages of controllable delivery speed, high recovery efficiency, simple operation and reusability.

Drawings

Fig. 1 is a schematic structural diagram of a conveying device according to a first embodiment of the invention;

FIG. 2 is a schematic cross-sectional view of the overall structure of a conveying device according to a first embodiment of the present invention;

FIG. 3 is a schematic cross-sectional view of a mandrel according to a first embodiment of the present invention;

FIG. 4 is a schematic cross-sectional view of an outer sheath assembly in accordance with a first embodiment of the invention;

fig. 5 is a schematic view of a first housing connection structure according to a first embodiment of the invention;

fig. 6 is a schematic view of a second housing connection structure according to a first embodiment of the invention;

fig. 7 is a schematic view of a notch of a first housing according to a first embodiment of the invention;

FIG. 8 is a schematic view of a locking knob according to a first embodiment of the present invention;

in the figure: the device comprises a core shaft assembly 1, a core shaft 11, a handle 12, a sheath tube assembly 2, a sheath tube 21, a first sleeve 22, a silica gel gasket 23, a second sleeve 24, a shell 3, a first shell 31, a first knob 311, a first shell upper piece 312, a first shell lower piece 313, a second knob 314, a second shell 32, a second shell upper piece 321, a second shell lower piece 322, a tail knob 323, an adjusting assembly 4, a transmission rod 41, a transmission rod knob 42 and a locking knob 43.

Detailed Description

In order to more clearly illustrate the embodiments of the present invention, the following description will explain the embodiments of the present invention with reference to the accompanying drawings. It is obvious that the drawings in the following description are only some examples of the invention, and that for a person skilled in the art, other drawings and embodiments can be derived from them without inventive effort.

The first embodiment is as follows:

as shown in fig. 1-2, the present embodiment provides a prosthetic heart valve delivery device comprising an inner mandrel assembly 1, an outer mandrel assembly 2, a housing 3, and an adjustment assembly 4. The inner mandrel component 1 comprises a mandrel 11 and a handle 12, and the handle 12 is installed at the end of the mandrel. The sheath tube assembly 2 comprises a sheath tube 21, the housing 3 comprises a first housing 31 and a second housing 32, the adjusting assembly 4 comprises a transmission rod 41, a transmission rod knob 42 and a locking knob 43, the locking knob 43 is in threaded connection with the second housing 32, the transmission rod 41 is in threaded transmission with the transmission rod knob 42, and the first housing 31 is in threaded fit with the second housing 32 through the transmission rod 41.

Specifically, a transmission rod 41 is installed between the second housing 32 and the first housing 31, a transmission rod knob 42 and a locking knob 43 are installed on the second housing 32, the sheath 21 is in transmission connection with the first housing 31, and the mandrel 11 is inserted into the sheath 21, the first housing 31, the transmission rod 41 and the second housing 32; the valve is loaded between the sheath tube 21 and the mandrel 11, and the transmission rod 41 moves along the second shell 32 by rotating the transmission rod knob 42 so as to release the valve; turning the locking knob 43, the mandrel 11 slides into contact with the sheath 21 to secure the mandrel 11 for delivery of the valve.

The first housing 31 is fixedly connected to the sheath 21, the sheath 21 is a hollow structure, and the sheath 21 is provided with a first boss. The mandrel 11 is provided with a second boss, the second boss is matched with the first boss in a clamping mode, a groove is formed in the second boss, and the groove is matched with the valve.

As shown in fig. 3, the inner mandrel component 1 comprises a mandrel 11 and a handle 12, wherein a conical guide structure is arranged at the top end of the mandrel 11, the conical guide structure can be independently used as a component or integrally connected with the mandrel 11, and the delivery device can enter the human body conveniently during the operation process to play a guiding role. The second boss structure is used for limiting the position of the valve, the second boss structure can be provided with structures such as grooves and the like, is matched with the valve, is connected to the tail structure of the valve and limits the circumferential movement of the valve, and the shapes of the grooves can be set to be different shapes such as I-shaped, T-shaped or L-shaped. The second boss structure may also function alone as a member to cooperate with the spindle 11 to accomplish this function. In order to observe and determine the valve position in operation, developing materials need to be added to the conical guide structure and the second boss structure, barium sulfate and the like with certain content can be added to the whole material for development, grooves or counter bores can be added, and the developing materials are matched with developing rings or developing points made of metal materials such as platinum or iridium to achieve the function. The end of the mandrel 11 is provided with a handle 12, which is convenient for hand grasping and other operations during adjustment.

As shown in fig. 4, the outer sheath assembly 2 includes an outer sheath 21, a first sleeve 22, a silicone gasket 23 and a second sleeve 24, the inner diameter of the outer sheath 21 can be set to a single inner diameter or to a variable inner diameter, and the specific inner diameter can be any suitable value depending on the diameter of the compressed valve. The rear section of the cavity with the larger inner diameter at the front end is provided with a first boss and is matched with a second boss of the mandrel 11 to load a valve, wherein the first boss part can also be an independent component, a hole matched with the 11 mandrel is formed in the first boss, and the diameter of the first boss is larger than 0.1-0.5 mm of the 11 mandrel so as to ensure matching.

The tail end of the outer sheath 21 is sleeved with a first sleeve 22, a step hole is arranged in the first sleeve, the inner diameter of the front end of the first sleeve is larger than the outer diameter of the tail end of the outer sheath 21, the step plane part is contacted with the tail part of the outer sheath 21, and the first sleeve and the step plane part can be connected in a threaded manner, an adhesive manner and the like. The inner diameter of the rear end of the stepped hole is matched 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 so as to ensure the matching with the outer sheath tube.

The second sleeve 24 is established to the outside cover of first sleeve 22, and second sleeve 24 is inside to be equipped with the step hole, and wherein the front end internal diameter is greater than first sleeve 22 external diameter, and modes such as both connection forms are not limited to screw thread or gluing, and step hole rear end internal diameter cooperates with dabber 11, slightly is greater than dabber 11 internal diameter. A silica gel gasket 23 is arranged between the first sleeve 22 and the second sleeve 24, the inner diameter of the silica gel gasket 23 is matched with the mandrel 11, and the outer diameter of the silica gel gasket is matched with the second sleeve 24, so that the sealing performance of the whole outer sheath tube 24 is ensured. Wherein, outer sheath pipe 21 and first sleeve 22 adopt connection modes such as gluing or spacing muscle groove between first sleeve 22 and the second sleeve 24 to guarantee the fixed of axial and circumference, as a global motion during the adjustment.

As shown in fig. 5, the first housing 31 includes a first knob 311, a first housing upper piece 312, a first housing lower piece 313 and a second knob 314, the first housing 31 has two cavities therein, the front end of the first housing is engaged with the sheath 21, and the rear end of the first housing is engaged with the transmission rod 41, and the engagement shape of the two is not limited to a cylindrical or stepped structure. The matching structure is provided with a limiting groove and a limiting rib for limiting circumferential movement between the limiting groove and the limiting rib, the limiting structure can be provided with one or more limiting ribs, and the shape is not limited to a groove boss structure.

The first knob 311 and the second knob 314 respectively limit the connection between the first housing upper piece 312 and the first housing lower piece 313 and the transmission rod 41 or the sheath tube 21 at two ends, and the knob structure may also be other structural members, for example, the connection may be achieved by directly providing a snap, a pin hole interference fit, or a threaded screw connection on the two-piece structure. At the axial distal end of silica gel gasket 23, be equipped with the through-hole and pass first casing 31, second sleeve 24 and first sleeve 22 in proper order, this through-hole can connect the evacuation pipe external diameter, adopts modes such as bonding and evacuation union coupling, also can slightly be less than the evacuation pipe internal diameter, need increase the boss at the casing this moment, and external diameter and evacuation pipe internal diameter cooperate, adopt modes such as bonding to connect the evacuation pipe.

As shown in fig. 6, the second housing 32 includes a second housing upper plate 321, a second housing lower plate 322, and a tail knob 323, and the transmission rod knob 42 is provided with a slot, which is engaged with the second housing 32 and axially fixed. But the connection in the circumferential direction is rotatable, and the connection can adopt but is not limited to snap connection. The second housing 32 is provided with a cavity therein for accommodating the transmission rod 41 during transmission, wherein the length of the cavity is greater than the transmission distance to ensure that the transmission can be completely implemented. 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. The cavity is internally provided with a guide or limit strip which is matched with a groove on the transmission rod 41 to limit the circumferential movement of the transmission rod 41, so that when the transmission rod knob 42 is rotated, the transmission rod 41 can only advance or retreat along the axial direction, and the safety of valve release and the efficiency of valve release are ensured.

The tail end of the second shell 32 is provided with a tail end knob 323 for connecting and fixing the second shell upper plate 321 and the second shell lower plate 322, the tail end of the second shell 32 is connected with the locking knob 43, wherein the locking knob 43 is internally provided with a taper hole which is matched with the taper structure at the tail end of the second shell 32 for locking the mandrel 11, and the matching taper can be the same slope, and the slope of the taper hole can also be selected to be smaller than the tail end taper structure of the second shell 32.

As shown in fig. 7, the tapered structure at the tail of the second casing 32 is circumferentially provided with two or more notches, so as to ensure that the tapered structure has a certain circumferential deformation. The proximal end of the tail knob 323, which is engaged with the locking knob 43, may be provided with a symbol for indicating a scale mark or the like, which indicates whether the locking knob is locked or unlocked.

As shown in fig. 8, when in the locked state, the taper hole of the locking knob 43 has a smaller slope than the taper structure at the rear end of the second housing 32, and when the rotation knob advances, the taper hole gradually contacts and interferes with the taper structure at the rear end, and the taper structure at the rear end with the notch deforms, thereby compressing the central portion of the mandrel 11, thereby locking the mandrel 11 and limiting the circumferential rotation and axial movement of the mandrel 11.

In the initial state, the valve is compressed into the inner side of the sheath and loaded in cooperation with the mandrel 11, and at this time, the locking knob 43 is in the locking state, and the mandrel 11 is fixed and connected with the second housing 32. During operation, the mandrel 11 and the sheath 21 are sent into the human body, and after the implantation position is determined by visualization, the transmission rod knob 42 is rotated clockwise, and the transmission rod 41 engaged therewith slides back in the axial direction, and the valve is slowly exposed. With the increase of the retraction distance, the valve is released more and more, and can be ejected to achieve complete release after being completely exposed by the clamping groove part of the mandrel 11. When the valve is completely released, the locking knob 43 can be opened, the second housing 32 is gripped with one hand, the handle 12 on the mandrel 11 is pulled backwards with the other hand, the mandrel 11 slides rapidly until the tapered structure on the mandrel 11 contacts the sheath tube 21, the locking knob 43 is rotated in the opposite direction to fix the mandrel 11, and finally the whole delivery device is integrally recovered to the outside of the human body.

The mandrel 11 is quickly retracted to be in contact with the outer sheath tube 21, so that the situation that when the conveying device is integrally retracted, the mandrel 11 is partially not retracted after the outer sheath tube 21 is retracted, the diameter difference of the conical structure part of the mandrel 11 is large at the moment, secondary damage is possibly caused, the integral retraction time can be shortened due to the quick retraction, and the operation efficiency is improved.

Another quick retraction mode may be used for releasing the valve in the operation, if the length of the valve is long, the locking knob 43 may be opened under the condition of releasing a part of the valve, at this time, the handle of the fixing mandrel 11 pulls the second housing 32 to drive the transmission outer sheath tube 21 to retract quickly to release the valve stent, and this way can accelerate the valve release speed and improve the operation efficiency.

Accordingly, the present embodiments also provide a method of delivering a prosthetic heart valve, comprising the steps of:

(1) compressing the valve to the inner side of the outer sheath, and loading the valve and the mandrel in a matching manner;

(2) the mandrel and the outer sheath tube are sent into a human body, and after the implantation position is determined, the handle of the transmission rod is rotated to enable the transmission rod to slide along the axial direction of the second shell so as to release the valve;

(3) when the valve is released, the locking knob is opened to enable the mandrel to be in contact with the outer sheath, and the locking knob is rotated reversely to fix the mandrel so as to realize valve delivery.

The foregoing has outlined rather broadly the preferred embodiments and principles of the present invention and it will be appreciated that those skilled in the art may devise variations of the present invention that are within the spirit and scope of the appended claims.

Claims (10)

1. A heart valve prosthesis conveying device is characterized by comprising a shell, a mandrel, an outer sheath tube, a transmission rod and a locking knob, wherein the shell comprises a first shell and a second shell, the transmission rod is arranged between the second shell and the first shell, the transmission rod knob and the locking knob are arranged on the second shell, the outer sheath tube is in transmission connection with the first shell, and the mandrel is arranged in the outer sheath tube, the first shell, the transmission rod and the second shell in a penetrating manner; the valve is loaded between the sheath tube and the mandrel, and the transmission rod moves along the second shell by rotating the transmission rod knob so as to release the valve; and when the locking knob is rotated, the mandrel slides to be in contact with the outer sheath tube so as to fix the mandrel, so that the valve is conveyed.

2. The device for delivering a prosthetic heart valve of claim 1, wherein the first housing is fixedly connected to an outer sheath, the outer sheath is hollow, and the outer sheath is provided with a first boss.

3. The heart valve prosthesis delivery device of claim 2, wherein the mandrel has a second boss disposed thereon, the second boss snap-fit to the first boss, the second boss having a recess, the recess mating with the valve.

4. The prosthetic heart valve delivery device of claim 1, wherein the mandrel has a guide structure at one end and a handle at the other end, the guide structure engaging the outer sheath.

5. The prosthetic heart valve delivery device of claim 1, wherein the end of the outer sheath is provided with a first sleeve and a second sleeve, the second sleeve being disposed outside the first sleeve, and the second sleeve being longer than the first sleeve.

6. The prosthetic heart valve delivery device of claim 5, wherein the first sleeve has a stepped bore, wherein the first sleeve has an inner diameter greater than an outer diameter of the outer sheath, and wherein the stepped bore is in contacting engagement with the outer sheath.

7. The heart valve prosthesis delivery device of claim 1, wherein the transfer rod knob is provided with a slot, the slot is snap-fit with the second housing, and the locking knob is threaded with the second housing.

8. The prosthetic heart valve delivery device of claim 1, wherein the first housing and the second housing are threadably engaged by a transfer rod.

9. The prosthetic heart valve delivery device of claim 1, wherein the transfer rod is in threaded engagement with a transfer rod knob.

10. The method for delivering the prosthetic heart valve delivery device according to any one of claims 1 to 9, comprising the steps of:

(1) compressing and loading the valve between the sheath tube and the mandrel;

(2) the mandrel and the outer sheath tube are sent into a human body, and after the implantation position is determined, the handle of the transmission rod is rotated to enable the transmission rod to slide along the axial direction of the second shell so as to release the valve;

(3) when the valve is released, the locking knob is opened to enable the mandrel to be in contact with the outer sheath, and the locking knob is rotated reversely to fix the mandrel so as to realize valve delivery.

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