CN112790896A

CN112790896A - Intraluminal native valve reconstruction device and its working method

Info

Publication number: CN112790896A
Application number: CN202110080277.XA
Authority: CN
Inventors: 吕平
Original assignee: Aolvxin Wuhan Technology Co ltd; Union Hospital Tongji Medical College Huazhong University of Science and Technology
Current assignee: Aolvxin Wuhan Technology Co ltd; Union Hospital Tongji Medical College Huazhong University of Science and Technology
Priority date: 2021-01-21
Filing date: 2021-01-21
Publication date: 2021-05-14

Abstract

The invention belongs to the technical field of medical devices, and specifically discloses an intracavity autologous valve reconstruction device and a working method thereof. The construction device includes a tube body, a guide tube, a construction mechanism and a trocar. The pipe body has a support mechanism on one side of the end, and the other side is concave to form a cutting plane. The inside of the pipe body is a mid-pass structure; the guide pipe is movably penetrated in the pipe body; the construction mechanism is movably penetrated. Set in the tube body, it includes a dilator, which communicates through the interior; and a puncture device, which is penetrated through the central through part of the dilator. In the method of use, the guiding tube passes through the tube body and enters the valve construction object; the guiding tube is probed forward and deeply; the direction of the tube body is adjusted to make the support mechanism work and support, and one side of the cutting plane is close to the inner wall of the construction object. The invention adopts minimally invasive intervention, has less trauma and quick recovery, utilizes autologous blood vessels to form autologous valves, and has no external implants; after the puncture needle is punctured, it is expanded through the needle body sheath and dilator respectively, which is more conducive to valve formation and reduces the impact on the tube wall. influences.

Description

Intra-cavity autologous valve reconstruction device and working method thereof

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to an intra-cavity autologous valve reconstruction device and a working method thereof.

Background

Of the lower limb general surgical diseases and peripheral vascular diseases, about 1 million people suffer from varying degrees of varicose veins, and nearly half are caused by deep vein incompetence. And the incidence of chronic venous diseases is high along with the incidence of varicose diseases, which is the most common increase of the age in China, the average incidence age is 53.4 years, the general age of the patients is large, and the operation tolerance is poor.

The operation treatment mode aiming at the primary deep vein valve insufficiency mainly comprises the following steps: firstly, the valvular repair and forming operation aiming at the self-pathological changes of the valvular, such as the valvular repair and forming operation in the vein cavity, the valvular repair and forming operation outside the vein, the vein valve transplantation and the transposition operation, etc.; the other is to perform surgery on the vein wall (such as the technology disclosed in CN 110267624) by wrapping ring, wearing a ring, suturing, and placing an extravalvular narrowing device percutaneously.

Wherein, the vein wall needs to be cut open for the intracavitary repair in the vein valve repair operation, which has great damage to the patient and greatly increases the risk of postoperative deep vein thrombosis. The accuracy of the extraluminal repair is poor when the valve is repaired, the curative effect is inferior to that of the intravenous valve repair plasty, and meanwhile, the valve shape is changed, so that the anti-reflux capacity of the valve is influenced to a certain extent; the vein valve replacement needs to transplant the brachial vein or the axillary vein with the valve of the patient to the lesion, and the mode belongs to an open type operation and has great damage to the patient; aiming at the wrapping and ring shrinkage of the vein wall, the wearing of a ring, the circumferential sewing, the percutaneous placement of an extravalvular constriction device and the like, the tissue muscle of a patient needs to be cut to reach a lesion, and the injury to the patient is large.

Disclosure of Invention

Aiming at the problems, the invention provides an intracavitary autologous valve reconstruction device and a working method thereof, and mainly solves the problems that the existing open valve construction operation has large damage and is difficult to construct a valve in a blood vessel (or other similar vessels) in an intervention mode and the like.

In order to solve the problems, the invention adopts the following technical scheme:

an intraluminal native valve reconstruction device comprising

One side of the end part of the pipe body is provided with a supporting mechanism, the other side of the end part of the pipe body is concave inwards to form a cutting plane, the inside of the pipe body is of a through structure,

the guide tube is movably arranged in the tube body in a penetrating way;

the construction mechanism is movably arranged in the pipe body in a penetrating way and protrudes outwards from the cutting plane, and comprises

The dilator has a hollow interior and an expansion part at the outer side,

and the puncture outfit is arranged in the middle through part of the dilator in a penetrating way.

In one form, one end of the dilator is movable to the side of the cutting plane; and a negative pressure groove is formed in the cutting plane.

In one form, the build mechanism is located in a build chamber of the tubular body; the front end of the construction movable cavity is open, and cutting planes are formed on two sides of the construction movable cavity.

In one form, the dilator comprises

The inner tube of the dilator is internally and universally used for penetrating the puncture outfit;

the adjusting pipe is sleeved outside the expander inner pipe;

the expansion part can be bent outwards and deformed, and two ends of the expansion part are respectively connected to the front ends of the inner tube and the adjusting tube of the expander.

In one mode, the puncture outfit is of a through structure, and the rear end of the puncture outfit is provided with a liquid injection port; and a negative pressure air groove is arranged in the side wall of the pipe body, the negative pressure air groove is communicated with the negative pressure groove, and the driving mechanism of the supporting mechanism is arranged.

In one mode, the supporting mechanism is an inflatable airbag, and an inflation tube communicated with the inflatable airbag is arranged in the tube body.

In one mode, the puncture outfit comprises a puncture needle and a puncture needle sheath tube sleeved outside the puncture needle.

In one mode, the rear end of the tube body is provided with an operating handle; the operating handle is provided with

The expander push button drives the adjusting pipe to move back and forth to adjust the expansion or contraction of the expansion part;

the dilator operation knob is used for adjusting the dilator to move back and forth;

the puncture needle sheath tube operation knob adjusts the puncture needle sheath tube to move back and forth;

the puncture device is pushed and twisted to adjust the puncture needle to move back and forth;

the guide tube is inserted into the insertion hole and used for inserting the guide tube.

In one mode, the dilator operating knob is in threaded connection with the dilator, and the puncture needle sheath tube operating knob is in threaded connection with the puncture needle sheath tube.

In one mode, the puncture needle sheath tube operating button and the puncture device pushing button are located on the rear side of the dilator pushing button and the dilator operating button.

In one mode, the puncture needle is of a through structure, and the rear end of the puncture needle is provided with a liquid injection port; the guide tube is an ultrasonic catheter.

A method for using the self-valve reconstruction device in the cavity,

the tube body enters the object, and the guide tube penetrates through the tube body and enters the valve construction object;

the guide tube is deeply detected forwards, and the front end working part of the guide tube body reaches a construction area;

adjusting the direction of the pipe body to enable the supporting mechanism to work and support, enabling one side of the cutting plane to be attached to the inner wall of the valve construction object, and enabling the inner wall to be adsorbed by the negative pressure groove in a negative pressure mode;

a valve construction procedure: the puncture needle moves forwards to puncture the side wall of the valve construction object to form a notch, the puncture needle sheath tube moves forwards to open the notch through the sheath tube, the puncture needle is not required to be used all the time, and adverse effects caused by deviation in the advancing process of the puncture needle are avoided to the maximum extent; the dilator moves forwards, the puncture needle sheath is covered, the supporting mechanism is recovered, then the tube body moves backwards to the rear side of the expansion part, the expansion part expands, the incision on the inner wall of the valve construction object is further expanded, and the dilator is retracted to leave the construction area;

continuously moving the front end working part of the pipe body to the construction area, enabling the cutting plane to be tightly attached to the inner wall of the other side of the construction object, and enabling the inner wall to be adsorbed by the negative pressure groove in a negative pressure mode;

the valve construction procedure described above is repeated.

The invention has the beneficial effects that:

through minimally invasive intervention, the wound is small, the recovery is fast, the autologous valve is formed by using the autologous blood vessel, and no external implant is arranged; after puncture, the puncture needle is respectively expanded through the needle body tube sheath and the expander, which is more beneficial to valve formation and reduces the influence on the tube wall.

Drawings

FIG. 1 is a schematic view of the front end working portion of the present invention;

FIG. 2 is a schematic view of the dilator structure;

FIG. 3 is a schematic cross-sectional view of the handle of the present invention;

FIG. 4 is a schematic view of the structural position of the working portion in the blood vessel;

FIG. 5 is a schematic view of the front end structure of the puncture needle during puncturing;

FIG. 6 is a schematic view showing the puncture state of the puncture needle;

FIG. 7 is a schematic view of another embodiment of the supporting mechanism.

In the figure:

100 tubes, 111 supporting mechanisms, 112 cutting planes, 113 negative pressure grooves, 200 guide tubes, 300 construction mechanisms, 310 puncture outfits, 320 dilators, 321 dilating parts, 322 dilator inner tubes, 323 adjusting tubes, 400 operating handles, 410 negative pressure air ports, 420 inflation ports, 430 liquid injection ports, 440 dilator push buttons, 450 dilator operating buttons, 460 dilator operating buttons, 470 puncture outfits push buttons and 480 guide tube insertion holes.

Detailed Description

The invention will be further described with reference to the accompanying drawings in which:

as shown in figure 1, the intraluminal native valve reconstruction device comprises

One side of the end of the tube 100 is provided with a supporting mechanism 111, the other side is concave inwards to form a cutting plane 112, the interior of the tube 100 is of a hollow structure,

one way of forming the cutting plane 112 is to cut the front end of the tube 100 to expose the inner cavity of the front end of the tube 100, and at this time, the cut surface of the tube wall forms the cutting plane 112.

The guide tube 200 is movably arranged in the tube body 100 in a penetrating way; one approach is an ultrasound guide tube that can probe the interior of the vessel for imaging, providing location and internal condition references for subsequent valve construction.

The construction mechanism 300 is located in the construction movable cavity of the tube body 100; the front end of the construction cavity is open, and cutting planes 112 are formed on two sides.

A construction mechanism 300 movably inserted into the tubular body 100 and protruding out of the cutting plane 112, as shown in fig. 1, the upper side of the construction mechanism 300 protrudes out of the cutting plane 112 at two sides,

which comprises

The dilator 320 has a hollow interior and an expanding portion 321 on the outside,

a puncture instrument 310 inserted through the hollow portion of the dilator 320; the upper side of the puncture device 310 protrudes out of the cutting planes 112 on both sides, so that the puncture device 310 can keep piercing from the blood vessel wall during the puncture process.

As shown in fig. 2, one end of the dilator 320 can be moved to the side of the cutting plane 112; a negative pressure groove 113 is formed in the cutting plane 112; the arrangement of the negative pressure groove 113 enables the vessel wall to be adsorbed on the cutting plane 112 in the working process, and the vessel is locally concave as shown in fig. 5, so that the puncture needle can puncture the vessel more conveniently;

meanwhile, in some use environments, in order to ensure smooth puncture of the puncture needle without puncturing the blood vessel, the distance between the plane formed by the two cutting planes 112 and the puncture needle is smaller than the thickness of the blood vessel wall.

The dilator 320 comprises

An expander inner tube 322, the interior of which is used for penetrating the puncture outfit 310;

the adjusting pipe 323 is sleeved outside the expander inner pipe 322;

an expansion part 321 which can be bent outwards and deformed, and two ends of the expansion part are respectively connected with the front ends of the inner tube 322 and the adjusting tube 323 of the expander; the expansion portion 321 is in a multi-segment structure, and when it is compressed, the middle portion of the expansion portion 321 is expanded outward, and both ends are held on the expander inner tube 322.

The dilator operation knob 450 adjusts the dilator 320 to move back and forth, and one way of the dilator operation knob 450 is a knob which is in threaded connection with the relevant parts of the dilator 320, so that the adjustment of the front and back positions of the dilator 320 is realized when the dilator operation knob 450 rotates.

One way of doing this is that when the inner tube 322 of the expander moves backward, the expanding portion 321 is squeezed while the adjusting tube 323 is not moving, and the expanding portion of the expander 320 starts to work; at this time, the expander operation knob 450 is threadedly coupled to the adjustment tube 323.

The puncture outfit 310 is of a through structure, and the rear end of the puncture outfit is provided with a liquid injection port 430; a negative pressure air groove is formed in the side wall of the pipe body 100, and the rear end of the negative pressure air groove is connected with a negative pressure air port 410; a negative pressure air tank communicating with the negative pressure tank 113, and a driving mechanism 450 of the support mechanism 111.

The supporting mechanism 111 is an inflatable air bag, and an inflation tube communicated with the inflatable air bag is arranged in the tube body 100; the tail end is provided with an inflation inlet 420.

In another mode, as shown in fig. 7, the supporting mechanism 111 is a spread-type mechanical structure, and the supporting portion is spread by transmission.

The balloon cavity is used for filling and releasing pressure of the eccentric balloon; the negative pressure cavity is communicated with the negative pressure groove at the cutting end and is used for secondary fixation after the vessel wall is attached to the cutting plane.

The puncture outfit 310 comprises a puncture needle and a puncture needle sheath tube sleeved outside the puncture needle.

The outer diameter of the puncture needle is smaller than the thickness of the tube wall of the blood vessel; in some embodiments, the puncture needle is a hollow needle tube, physiological saline can be injected through the injection port of the operation end for injection and stripping of the blood vessel wall, and the setting height of the needle point and the cutting plane is 0.25 mm-0.5 mm for accurately controlling the layering thickness of the blood vessel.

Referring to fig. 3, the rear end of the tube 100 is provided with an operating handle 400; the operating handle 400 is provided with the following components,

in another working mode of the expander 320, the expander push button 440 is connected with the driving adjusting pipe 323, and the driving adjusting pipe 323 moves back and forth to adjust the expansion or contraction of the expanding part 321; the dilator operation knob 450 is connected with the dilator inner tube 322;

the dilator operation knob 450 is in threaded connection with the dilator 320, and the puncture needle sheath operation knob 460 is in threaded connection with the puncture needle sheath.

The puncture needle sheath manipulation knob 460 adjusts the puncture needle sheath to move back and forth, and one way of the puncture needle sheath manipulation knob 460 is a knob, which is in threaded connection with the puncture needle sheath, and adjusts the puncture needle sheath thread to move back and forth during the rotation of the puncture needle sheath manipulation knob 460.

The puncture device push button 470 adjusts the puncture needle to move back and forth, a certain movement margin is arranged at the installation position of the puncture device push button 470, and the puncture needle is driven to move back and forth when the puncture device push button 470 is pushed.

A guide tube insertion hole 480 for inserting the guide tube 200 and the guide wire.

The puncture needle sheath tube operation knob 460 (needle sheath tube knob) and the puncture device push knob 470 (puncture needle push knob) are positioned at the rear side of the dilator push knob 440 (dilator push knob) and the dilator operation knob 450 (dilator knob).

The puncture needle can be pushed to slide along the axial direction of the apparatus by the puncture needle push button, so that the blood vessel wall can be punctured accurately; the needle sheath can be controlled to slowly advance to the far end at a constant speed by adjusting the knob of the needle sheath; the adjustment of the whole position of the valve dilator can be controlled by adjusting the knob of the dilator, the dilation push button is arranged on the knob of the dilator, and the whole dilation and contraction of the dilator can be realized by utilizing the spring structure. The tail part of the operating handle is provided with an ultrasonic catheter cavity interface, the front end of the handle is provided with a balloon filling interface and a negative pressure interface, and the middle part of the handle is provided with an injection interface which is respectively connected with each inner cavity in the multi-cavity catheter.

The puncture needle is of a through structure, and the rear end of the puncture needle is provided with a liquid injection port 430; the guide tube 200 is an ultrasound catheter. The guide wire and the ultrasonic catheter can flexibly slide in the ultrasonic catheter cavity.

In connection with the method of use of the intraluminal native valve reconstruction device illustrated in fig. 4,

the tube body 100 enters the subject, and the guide tube 200 passes through the tube body 100 and enters the valve construction subject;

the guide tube 200 is deeply detected forwards, and the front working part of the guide tube body 100 reaches a construction area;

referring to fig. 5, the direction of the tube 100 is adjusted to support the support mechanism 111, so that one side of the cutting plane 112 is close to the inner wall of the valve building object, and the inner wall is sucked by the negative pressure groove 113 under negative pressure;

a valve construction procedure: the puncture needle moves forwards to puncture the side wall of the valve construction object to form an incision, the puncture needle sheath moves forwards to prop open the incision, the dilator 320 moves forwards to cover the puncture needle sheath, the supporting mechanism 111 is recovered, then the tube body 100 moves backwards to the rear side of the dilating part 321, the dilating part 321 is dilated, the incision on the inner wall of the valve construction object is further widened, and the dilator 320 is recovered to leave a construction area;

continuously moving the front end working part of the tube 100 to the construction area, so that the cutting plane 112 is tightly attached to the inner wall of the other side of the construction object, and the inner wall is sucked by the negative pressure groove 113 under negative pressure;

the valve construction procedure described above is repeated.

With reference to fig. 5 and 6, when constructing a vascular valve, the specific operation flow is as follows:

and inserting a guide wire with a proper size from an ultrasonic catheter cavity interface at the tail end of the instrument, and entering a blood vessel through a minimally invasive incision. After the apparatus catheter reaches a specific blood vessel position under the guidance of the guide wire, the guide wire is pulled out, and the ivus ultrasonic catheter is inserted into the tail end ultrasonic catheter cavity;

guiding a cutting end head at the front end of the instrument through a minimally invasive ultrasonic catheter to determine the position of the valve making in the blood vessel;

then the vessel wall is tightly attached to the cutting plane of the catheter by balloon expansion, negative pressure adsorption fixation and other modes;

the rear end puncture needle push button is pushed to accurately puncture the vascular wall along the vascular direction, and physiological saline with certain pressure is injected through the puncture needle tube, so that the vascular intima is separated from the vascular muscularis, and a slender layered cavity is formed;

the cutting plane and the groove structure of the negative pressure groove can limit the vessel wall from excessively extending along the radial direction of the layering cavity in the layering process;

after the layering stroke is finished, the operator rotates the expander knob to extend the valve expander into the prepared layering cavity by taking the middle puncture needle as a guide;

the saccule and the negative pressure restraint are removed, the radial limit of the vessel wall and the cutting plane is removed, the expansion push button is pushed, the expansion and the contraction of the valve expander are controlled, and the valve making and the shaping of the autologous valve are completed.

And finally, repeating the steps, manufacturing another valve at the same position on the other side of the blood vessel, and finally finishing the molding of the self-valve.

As shown in fig. 6, the vessel wall is accurately punctured along the blood vessel direction by a puncture needle, physiological saline with certain pressure is led along the puncture needle to separate the vessel wall into 2 layers, and finally, the separated vessel wall is expanded by using an expansion device to form a piece of valve. And finally, repeating the steps, manufacturing another valve at the same position on the other side of the blood vessel, and finally finishing the molding of the self-valve. The venous return can be corrected after the autologous valve is formed, and the symptoms of a patient can be effectively relieved.

Minimally invasive intervention: the wound is small, the recovery is fast, the pain is light, and the operation time is short;

local anesthesia: the anesthesia risk is small, and the resuscitation speed of the patient is high;

no implant: the native valve is formed by using the native blood vessel without an external implant.

It will be apparent to those skilled in the art that various modifications may be made to the above embodiments without departing from the general spirit and concept of the invention. All falling within the scope of protection of the present invention. The protection scheme of the invention is subject to the appended claims.

Claims

1. The self-body valve rebuilds device in cavity, its characterized in that: comprises that

A supporting mechanism (111) is arranged on one side of the end part of the pipe body (100), a cutting plane (112) is formed by recessing the other side of the end part of the pipe body (100), the interior of the pipe body (100) is of a hollow structure,

the guide tube (200) is movably arranged in the tube body (100) in a penetrating way;

a construction mechanism (300) movably arranged in the pipe body (100) and protruding out of the cutting plane (112), which comprises

An expander (320) having a hollow interior and an expanding portion (321) on the outside,

and a puncture device (310) which is arranged in the middle through part of the dilator (320) in a penetrating way.

2. The endoluminal native valve reconstruction device according to claim 1, wherein: one end of the dilator (320) can move to the side of the cutting plane (112); and a negative pressure groove (113) is formed in the cutting plane (112).

3. The endoluminal native valve reconstruction device according to claim 2, wherein: the construction mechanism (300) is positioned in a construction movable cavity of the tube body (100); the front end of the construction movable cavity is open, and two sides form a cutting plane (112).

4. The endoluminal native valve reconstruction device according to claim 1, wherein: the dilator (320) comprises

An expander inner tube (322) with the inner part being used for penetrating the puncture outfit (310);

the adjusting pipe (323) is sleeved outside the expander inner pipe (322);

the expansion part (321) can be bent outwards and deformed, and two ends of the expansion part are respectively connected with the front ends of the inner tube (322) and the adjusting tube (323) of the expander.

5. The endoluminal native valve reconstruction device according to claim 2, wherein: the puncture outfit (310) is of a through structure, and the rear end of the puncture outfit is provided with a liquid injection port (430); and a negative pressure air groove is formed in the side wall of the pipe body (100), the negative pressure air groove is communicated with the negative pressure groove (113), and the driving mechanism (450) of the supporting mechanism (111) is further arranged.

6. The endoluminal native valve reconstruction device according to claim 1, wherein: the supporting mechanism (111) is an inflatable air bag, and an inflatable tube communicated with the inflatable air bag is arranged in the tube body (100).

7. The endoluminal native valve reconstruction device according to claim 1, wherein: the puncture outfit (310) comprises a puncture needle and a puncture needle sheath tube sleeved outside the puncture needle.

8. The endoluminal native valve reconstruction device according to claim 7, wherein: an operating handle (400) is arranged at the rear end of the tube body (100); the operating handle (400) is provided with

The expander push button (440) drives the adjusting pipe (323) to move back and forth to adjust the expansion or contraction of the expansion part (321);

a dilator operating knob (450) for adjusting the dilator (320) to move back and forth;

the puncture needle sheath tube operation knob (460) is used for adjusting the puncture needle sheath tube to move back and forth;

the puncture device push button (470) is used for adjusting the puncture needle to move back and forth;

a guide tube inserting hole (480) for inserting the guide tube (200).

9. The endoluminal native valve reconstruction device according to claim 8, wherein: the dilator operation knob (450) is in threaded connection with the dilator (320), and the puncture needle sheath tube operation knob (460) is in threaded connection with the puncture needle sheath tube.

10. The endoluminal native valve reconstruction device according to claim 8, wherein: the puncture needle sheath tube operating knob (460) and the puncture device pushing knob (470) are positioned at the rear sides of the dilator pushing knob (440) and the dilator operating knob (450).

11. The endoluminal native valve reconstruction device according to claim 7, wherein: the puncture needle is of a through structure, and the rear end of the puncture needle is provided with a liquid injection port (430); the guide tube (200) is an ultrasonic catheter.

12. The method of using the endoluminal native valve reconstruction device of any of claims 1-11, wherein:

a tube body (100) enters the object, and a guide tube (200) penetrates through the tube body (100) to enter the valve construction object;

the guide tube (200) is deeply detected forwards, and the front end working part of the guide tube body (100) reaches a construction area;

adjusting the direction of the pipe body (100), enabling the supporting mechanism (111) to work and support, enabling one side of the cutting plane (112) to be attached to the inner wall of the valve construction object, and enabling the inner wall to be adsorbed by the negative pressure groove (113) in a negative pressure mode;

a valve construction procedure: the puncture needle moves forwards to puncture the side wall of the valve construction object to form an incision, the puncture needle sheath tube moves forwards to prop open the incision, the dilator (320) moves forwards to cover the puncture needle sheath tube and recover the support mechanism (111), then the tube body (100) moves backwards to the rear side of the expansion part (321), the expansion part (321) expands to further widen and prop the incision on the inner wall of the valve construction object, and the dilator (320) is recovered to leave a construction area;

continuously moving the front end working part of the pipe body (100) to a construction area, enabling the cutting plane (112) to be attached to the inner wall of the other side of the construction object, and enabling the inner wall to be adsorbed by the negative pressure groove (113) in a negative pressure mode;

the valve construction procedure described above is repeated.