CN212037832U - Unlockable mitral valve clip and delivery system - Google Patents

Unlockable mitral valve clip and delivery system Download PDF

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Publication number
CN212037832U
CN212037832U CN201921840939.3U CN201921840939U CN212037832U CN 212037832 U CN212037832 U CN 212037832U CN 201921840939 U CN201921840939 U CN 201921840939U CN 212037832 U CN212037832 U CN 212037832U
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clamp
valve clamp
mitral valve
clip
section
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CN201921840939.3U
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张亦赫
张亦喆
张令天
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Beijing Hangtian Kadi Technology R & D Institute
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Beijing Hangtian Kadi Technology R & D Institute
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Abstract

The invention discloses an unlockable mitral valve clamp and a conveying system, which comprise an unlockable mitral valve clamp and a conveyor, wherein the mitral valve clamp consists of an upper valve clamp component, a lower valve clamp component and a spring staple bolt or a leaf spring clamp unlocking device, the conveyor consists of an outward push-pull pipe, a screw rod or a clamping pipe, an unlocking pipe or an unlocking tilted pipe and a sheath pipe, the upper valve clamp and the lower valve clamp are connected with the conveyor, and can be separated, locked and unlocked under the push-pull action of the upper valve clamp and the lower valve clamp, the conveyor component supports the mitral valve clamp, and the mitral valve clamp is inserted and clamped by minimally invasive intervention from the apex of the heart to prevent backflow.

Description

Unlockable mitral valve clip and delivery system
Technical Field
The invention belongs to the field of implanted medical instruments, and particularly relates to an unlockable mitral valve clamp and a delivery system for treating mitral regurgitation.
Background
Heart failure can be caused by regurgitation of the mitral valve of the heart. And can be fatal. The number of mitral regurgitation patients in China is estimated to be approximately ten million. Surgical treatment is usually performed on patients by edge-to-edge suturing, suture ring implantation, etc. The operation of the surgery needs thoracotomy, the operation wound is large, the cost is high, the recovery is slow, and the operation death rate of the elderly and patients with serious illness is high.
Inspired by the treatment of mitral regurgitation by mitral valve edge bilateral suture, the Mitra Clip interventional mitral valve Clip and the delivery system are invented to treat the mitral regurgitation in early foreign countries. The product passes European Union certification in 2008, is approved to be on the market by FDA in 2013, and is popularized and used in French in plain.
The structure of the mitral valve clamp and the conveying system thereof is very complex, and the intervention way is adopted; the vein-the right atrium-the left ventricle-must puncture the interatrial septum. The intervention is also complicated, time consuming and technically difficult to master.
The invention or the application of the utility model patent is recently developed in China, the lock rod is square, occupies a large space, can not be unlocked mostly, and can not correct the bad effect in the operation. The interventional mitral valve clamp is operated under the monitoring of ultrasonic images, sometimes the clamping position is found to be not required to be modified, some applications assume that an unlocking scheme is to pull a plastic insertion sheet or a spiral tube in a reverse direction by a large force, and the feasibility, reliability and operability are suspicious or poor. The invention overcomes the defects of the prior design and creates a feasible, reliable and conveniently operated and unlockable mitral valve clamp and delivery system.
The invention content is as follows:
the invention discloses a mitral valve clamp capable of being unlocked and a delivery system, which comprises a main body and a delivery device, wherein the main body comprises: a lockable mitral valve clip (shortly mitral valve clip or valve clip) and a delivery device. The mitral valve clamp is matched with a conveyor, and the clamping arms of the upper valve clamp and the lower valve clamp can be separated, locked and unlocked. The transporter assembly supports the mitral valve clamp, minimally invasive access from the apex, and clamps the mitral valve leaflets against regurgitation.
The technical problem related to the invention is realized by the following modes:
the mitral valve clip of the present invention is provided with two unlockable schemes. The mitral valve clamp of the first scheme consists of an upper valve clamp member, a lower valve clamp member and a spring staple, and the second scheme consists of an upper valve clamp member and a lower valve clamp member provided with a leaf spring clip. The conveyer consists of an outer push-pull pipe, a screw rod or a clamping pipe, an unlocking pipe or an unlocking tilted pipe and an intervention sheath pipe.
The two-scheme valve clamp is provided with a clamping arm and a sleeving section. The upper and lower petal clamps are respectively provided with two sheet-shaped clamp arms which are mutually symmetrical, and the upper and lower clamp arms can be clamped in a closing way. The strip-shaped clamping arm can be correspondingly in an arc shape (the arc center is below) or provided with a straight neck section and an arc section or in a strip clamp shape (only the front ends of the upper clamping arm and the lower clamping arm are contacted first), and the root of the clamping arm has high elasticity and resilience. The upper clamping arm and the lower clamping arm are provided with spread angles, and when the upper clamping arm and the lower clamping arm are aligned, the valve leaf is transversely clamped by the alignment surface. The two schemes have different locking and unlocking modes of the sleeving section.
The upper petal clamp sleeving section of the first scheme is in a sheet rectangle and is connected with the root of the clamping arm, the corresponding position of the spring clamping nail outside the wide surface and the lower petal clamp sleeving section is provided with an inclined nail hole, and the tail section is provided with a screw or a clamping groove which can be connected with a screw rod or a clamping pipe of a conveyor.
The corresponding lower petal clamp sleeving section of the first scheme is cylindrical, a sheet rectangular sleeving section with a gap capable of penetrating the upper petal clamp sleeving section is arranged in the lower petal clamp sleeving section, symmetrical transverse convex rods capable of being clamped with an outer push-pull pipe of a conveyor are arranged outside the lower petal clamp sleeving section, an inclined hole capable of guiding a spring staple is arranged at the lower part of the lower petal clamp sleeving section, and the inclination of the inclined hole is consistent with that of the upper petal clamp inclined nail hole.
The spring bail of first scheme contains the location section, and the spring section, the bail section is one kind around the cover and presss from both sides the pressure spring outside the section cylinder of cup jointing under the lamella, goes up the radial nail of inlaying of free end and cup joints section cylinder upper segment, and the leading-in section inclined hole that cup joints of lower extreme bail.
When the upper and lower clip are sleeved, the end of the staple clip is pushed to slide on the surface of the sleeved section of the upper clip, and the upper and lower clip arms can be opened and closed before locking. When the clamping arms clamp the valve leaflets, the clamping nail ends can penetrate into the inclined nail holes of the sleeving sections of the upper valve clamps right, and the upper valve clamps and the lower valve clamps are locked.
When the spring of the spring staple is compressed by the unlocking tube, the staple moves along with the spring, and the end part of the staple moves away from the inclined staple hole to unlock.
The upper petal clamp sleeving section of the second scheme is in a sheet shape and is rectangular, a clamping hole is formed in the wide surface of the sleeving section, and a screw or a clamping groove is formed in the tail end of the sleeving section.
In the second scheme, the lower petal clamp sleeving section corresponding to the upper petal clamp is rectangular, a rectangular sleeving section with a gap capable of allowing the upper petal clamp to pass is arranged in the lower petal clamp sleeving section, symmetrical transverse convex rods capable of being clamped with an outer push-pull pipe of the conveyor are arranged outside the sleeving section and in the parallel direction of the clamping arms, leaf spring clamps are arranged in the vertical direction of the clamping arms, and clamping teeth of the leaf spring clamps can be matched with clamping holes of the upper petal clamp in an embedded manner.
The second scheme leaf spring card is established and is pressed from both sides the section one side of cup jointing in the lower lamella, and leaf spring card upper portion elasticity section is cup jointed a section partly, the elasticity curtain of similar one side, and the latch is established and is put under the section is cup jointed to leaf spring midsection position, and the latch is established the inclined plane, and leaf spring card lower extreme is for perk to separate the section and the section is cup jointed to the upper lamella clamp has certain clearance.
When the upper and lower valve clips are sleeved, the upper sleeving section can push the latch inclined plane of the leaf spring clip to enter the lower sleeving section, the latch can slide along the upper sleeving section, and the clamping arm can be opened and closed.
When the clamping arms clamp the valve leaf, the clamping teeth can just penetrate into the clamping holes of the sleeving section of the upper valve clamp to lock the upper valve clamp and the lower valve clamp, and when the tilting section of the leaf spring is tilted by the unlocking pipe, the clamping teeth can move along with the leaf spring to separate from the clamping holes to unlock
The clamping arms of the mitral valve clips of the two schemes are correspondingly arc-shaped strips or provided with straight neck sections and arc sections or strip clip shapes, and in order to increase the embedding friction force of the mitral valve clips on valve leaflets, the opposite surfaces can be provided with series of convex nails or thorns or have no acute angle convex-concave grains or micropores or pitted surfaces.
Except the clamping arm involution surface, other surfaces of the mitral valve clamp adopting the two schemes can be plated with a parylene coating or a coated fabric with lubricating property and anti-thrombosis performance.
The front end of an outer push-pull pipe of the conveyor is provided with a bayonet which can be clamped with a mitral valve convex rod, a screw rod or a clamping pipe is screwed or clamped with the tail end of a connecting section of an upper valve clamp sleeve, an unlocking pipe of the first scheme can be slid in the outer push-pull pipe in a sliding way, the inner diameter of the unlocking pipe is slightly larger than that of a cylinder of the connecting section of a lower valve clamp sleeve, and a spring can be pushed to unlock. The tilting section of the unlocking tilting tube in the second scheme can extend into the gap of the expanding tilting section, so that the latch is separated from the upper petal clamping hole to unlock. The external push-pull pipe and the spiral pipe or the clamping pipe are pushed and pulled relatively to complete the opening, closing and locking of the upper and lower clamping arms, and the external push-pull pipe and the unlocking pipe are pulled and pushed to complete the unlocking.
The conveyor tube is provided with scale markings for manipulating the action and position of the mitral valve clamp.
The benefits of the mitral valve clip and conveyor system of the present invention are:
the mitral valve clip and the conveyor have novel and simple structure, easy processing and convenient use.
The mitral valve clamp is matched with the conveyor, so that the clamp arm can be opened, locked and unlocked, the unlocking mode is simple and reliable, and the operation can be repeatedly optimized and adjusted.
The clamping arms of the mitral valve clamp have arc sections close to the natural state of valve leaflets, and the mitral valve clamp has good adaptability and is also suitable for applying coaptation clamping force to the valve leaflets.
The upper and lower clamping arms of the mitral valve clamp are provided with the coating fabrics which are beneficial to the growth of biological tissue membrane and the nutrient supply of valve leaflets and reduce the damage to the valve leaflets
The coated parylene coating of the mitral valve clamp can completely cover the surface without pores, including corner defects, has excellent antithrombotic performance, and can reduce the operation resistance due to the lubricating property.
The upper valve clip sleeve joint section is in a sheet shape, the whole volume of the mitral valve clip can be reduced, and the clamped valve leaf is closer to the upper valve clip sleeve joint section, so that the backflow is prevented.
The conveyer is convenient to mount and discharge, is provided with scale marks, is accurate in operation and prevents misoperation.
Drawings
FIG. 1 is a schematic view of a first aspect of a clip
FIG. 2 is a schematic view of a clip of the first embodiment
FIG. 3 is a schematic view of a spring staple according to a first embodiment
FIG. 4 is a schematic view of the opening of the clamping arms of the first embodiment of the mitral valve clamp
FIG. 5 is a schematic view of the involution of the clamping arms of the first mitral valve clamp assembly
FIG. 6 is a schematic view of a second embodiment of an upper clip
FIG. 7 is a schematic view of a second embodiment of a lower clip
FIG. 8 is a schematic view showing the opening of the fitting clip arms of the mitral valve clip according to the second embodiment
FIG. 9 is a schematic view of the fitting clip arms of the mitral valve clip of the second embodiment
FIG. 10 is a schematic view showing the order of assembling the screw rod, the unlocking tube, the outer push-pull tube and the sheath tube of the conveyer
Detailed Description
Example one
Referring to FIGS. 1-5 and 10
The upper petal clamp 1-1 is provided with symmetrical strip-shaped clamping arms 1-101, the lower involutory surface can be additionally provided with a series of acute-angle-free convex-concave grains 1-102 for increasing the embedding friction force, the elastic root parts 1-103 of the clamping arms are connected with the strip-shaped sleeve joint sections 1-104, the sleeve joint sections are provided with inclined positioning holes 1-105, and the tail sections are provided with screw ports 1-106.
The lower valve clamp 1-2 clamp arms 1-201 and the upper valve clamp 1-101 correspond to the clamp arms, the upper involutory surface is provided with a series of non-acute-angle concave-convex grains 1-202, when the upper valve clamp and the clamp arms of the upper valve clamp are involutory, the valve leaf can be embedded transversely, the clamping position is easy to find and adjust, and the clamping is stable and prevents slipping. The elastic root 1-203 of the clamping arm is connected with a cylindrical socket section 1-204, the middle of the cylindrical socket section is provided with a gap 1-205 capable of passing through the sheet socket section 1-104, the socket section is externally provided with symmetrical transverse convex rods 1-206, a positioning hole 1-207 is arranged at the near side of the convex rod, the lower part of the socket section is provided with an inclined hole 1-208, the direction of the inclined hole is vertical to the gap 1-205, and the bottom end of the inclined hole passes through the gap 1-205.
Spring staple 1-3 is placed around telescoping section 1-204 with its upper end 1-301 inserted into alignment hole 1-207 and compressible elastomeric section 1-302 is placed around telescoping section 1-204 with its staple 1-303 inserted through angled hole 1-208 and allowed to slide diagonally with its staple end 1-305 in gap 1-205 under the spring's extension tension.
When the upper clip socket section 1-104 is inserted into the gap 1-205 of the lower clip socket section 1-204, the upper clip socket section can push away the clamping nail end 305 in the chute to slide in the gap before locking, and drives the upper and lower clamping arms to open or close. When the socket joint sections 1-204 are pushed upwards, the socket joint sections 1-104 are pulled downwards, and the staple holes are locked when the end parts 1-305 of the staples are embedded into the spring staple positioning holes 1-206, the designed distance and force of the upper and lower clamping arms to the involutive embedded and clamped mitral valve leaflets are also achieved.
When the elastic section is compressed, the staple 1-303 moves upwards along the inclined hole 1-209, the end part 1-305 is separated from the inclined positioning hole 1-105, and the staple can be unlocked, and the upper clamping arm and the lower clamping arm can be opened and closed again.
Before operation, the bayonet 401 of the assembled mitral valve clamp and the outer push-pull tube 4 of the conveyor are clamped with the convex rods 1-207, and the screw 501 of the screw rod 5 is screwed with the screw mouths 1-105. The unlocking tube 6 is ready for use.
During operation, the spread angle closing of the clamping arm of the mitral valve clamp without locking and the conveyor are inserted into the intervention sheath 6 together to form an intervention kit. The left ventricle can be intervened from the apical incision in the left ventricle under the monitoring of the ultrasonic image from the minimally invasive chest incision, the upper clamping arm and the lower clamping arm are released and unfolded by withdrawing the sheath tube, and the screw rod is pushed to enable the upper clamping arm to enter the left atrium. Adjusting the valve blades clamped by the upper clamping arm and the lower clamping arm, pushing the outer push-pull pipe when the clamping position is suitable for deep clamping, pulling the screw rod to enable the end part 1-305 of the spring clamping nail to be embedded into the spring clamping positioning hole 1-206, completing the edge-to-edge clamping of the transverse valve blade, and forming double-hole backflow inhibition. If the clamping is not satisfactory, the unlocking tube 5 can be adopted, the outer push-pull tube 3 is pulled to push the unlocking tube 5 to compress the spring of the spring clamp, the end part 1-305 of the clamp is moved out of the positioning hole 1-206 to unlock, and the push screw rod separates the upper clamping arm and the lower clamping arm to operate again. After the clamping operation is satisfied, the conveyor device is withdrawn one by one to block the incision.
Example two
See Figs. 6-10
The upper petal clamp 2-1 is provided with symmetrical strip-shaped clamping arms 2-101, the mating surfaces can be additionally provided with series of acute-angle-free convex-concave lines 2-102 for increasing the embedding friction force, the elastic root parts 2-103 of the clamping arms are connected with the strip-shaped sleeve joint sections 2-104, the corresponding positions of the clamping arms are provided with clamping holes 2-105, and the tail sections are provided with screw ports 2-106.
The lower petal clamp 2-2 clamp arm 2-201 and the upper petal clamp arm 2-101 are correspondingly in a strip sheet shape, the upper involutory surface is provided with a series of non-acute-angle concave-convex grains 2-202, when the lower petal clamp arm and the upper petal clamp arm are involutory, the transverse tabling can be carried out on the petals, the clamping position is easy to find and adjust, and the clamping is stable and prevents slipping. The elastic root parts 2-203 of the clamping arms are connected with rectangular socket sections 2-204, gaps 2-205 capable of penetrating through the sheet socket sections 2-104 are arranged in the axial middle of the rectangular socket sections, transverse convex rods 2-206 of symmetrical parallel clamping arms are arranged outside the rectangular socket sections, and leaf spring clamps 2-207 are arranged in the vertical clamping arms in the axial direction.
The tablet yellow card is provided with 2-208 latch and 2-209 upwarping section
When the upper clip socket section 2-104 is inserted into the lower clip gap 2-205, the upper clip socket section 2-104 can push the leaf spring latch 2-208 open before locking, and slide in the gap to drive the upper and lower clip arms to open or close. When the sleeve joint section 2-204 is pushed upwards, the sleeve joint section 2-104 is pulled downwards, and the latch 2-208 is embedded into the upper valve clamp latch hole 2-105, the latch hole is locked, and the designed distance and force of the upper clamp arm and the lower clamp arm for folding and embedding the mitral valve leaf are also achieved.
When the leaf spring clip bendable section 2-209 is tilted by the conveyor tilting pipe, the clip teeth 2-208 are separated from the clip holes to be unlocked, and the upper clip arm and the lower clip arm can be opened and closed again.
Before operation, the bayonet 401 and the convex rod 207 of the assembled mitral valve clamp and the outer push-pull tube 4 of the conveyor are clamped, and the screw 501 of the screw rod 5 is in threaded connection with the screw ports 2-105. The unlocking tube 6 is ready for use.
During operation, the spread angle closing of the clamping arm of the mitral valve clamp without locking and the conveyor are inserted into the intervention sheath 6 together to form an intervention kit. The left ventricle can be intervened from the apical incision in the left ventricle under the monitoring of the ultrasonic image from the minimally invasive chest incision, the upper clamping arm and the lower clamping arm are released and unfolded by withdrawing the sheath tube, and the screw rod is pushed to enable the upper clamping arm to enter the left atrium. Adjusting the upper clamping arm and the lower clamping arm to clamp the valve leaf, pushing the outer push-pull pipe when the clamping position is suitable for deep clamping, pulling the screw rod to enable the leaf spring clamping teeth 2-208 to be embedded into the clamping holes 2-105, completing the edge-to-edge clamping of the transverse valve leaf, and forming double holes to inhibit backflow. If the clamping position is not satisfactory, the conveyer can be pulled to push the pull pipe outwards to push the tilting pipe, the tilting leaf spring clip tiltable section 2-209 enables the clip teeth 2-208 to move out of the clip holes 2-206 to be unlocked, and the push screw rod can be operated again after separating the upper clamping arm from the lower clamping arm. After the clamping operation is satisfied, the conveyor device is withdrawn one by one to block the incision.
The principle and the implementation mode of the invention are explained by applying specific examples, and the description of the above examples is only used for helping understanding the method and the core idea of the invention; meanwhile, for a person skilled in the art, according to the idea of the present invention, the specific embodiments and the application range may be changed. In summary, this summary should not be construed to limit the present invention.

Claims (7)

1. An unlockable mitral valve clip and delivery system, comprising: the device comprises a mitral valve clamp capable of being unlocked and a conveyor, wherein the mitral valve clamp consists of an upper valve clamp component, a lower valve clamp component and a spring staple bolt or a leaf spring clamp unlocking device, the conveyor consists of an outer push-pull tube, a screw rod or a clamping tube, an unlocking tube or an unlocking tilted tube and a sheath tube, the upper valve clamp and the lower valve clamp are connected with the conveyor, and the upper valve clamp and the lower valve clamp can be separated, locked and unlocked under the push-pull action of the upper valve clamp and the lower valve clamp.
2. The unlockable mitral valve clamp and delivery system of claim 1, wherein the symmetrical strip-shaped arms of the upper and lower valve clamps are shaped as an arc, a neck, an arc, or a strip clamp, and have a high elasticity at the root.
3. The unlockable mitral valve clip and delivery system of claim 1, wherein the upper and lower valve clips are fabric coated with parylene coating.
4. The unlockable mitral valve clamp and delivery system according to claim 1, wherein the upper valve clamp sleeve section has a rectangular sheet shape and is provided with an oblique staple hole or a clip hole for positioning a staple, and the tail end of the upper valve clamp sleeve section is provided with a screw or a bayonet.
5. The unlockable mitral valve clip and delivery system of claim 1, wherein the circular socket segment of the lower clip is provided with axial gaps, symmetrical protruding rods, positioning holes for the spring staples, and angled holes.
6. The unlockable mitral valve clip and delivery system of claim 1, wherein the spring staple, surrounding the lower clip telescoping section, comprises a positioning section, a spring section, and a staple section.
7. The unlockable mitral valve clamp and delivery system of claim 1, wherein the delivery device comprises an outer push tube, a screw or clamp tube, an unlocking tube, and a sheath tube, and wherein the delivery device is provided with scale marks operable to identify the relative position of the mitral valve clamp member.
CN201921840939.3U 2019-10-26 2019-10-26 Unlockable mitral valve clip and delivery system Active CN212037832U (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201921840939.3U CN212037832U (en) 2019-10-26 2019-10-26 Unlockable mitral valve clip and delivery system

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Application Number Priority Date Filing Date Title
CN201921840939.3U CN212037832U (en) 2019-10-26 2019-10-26 Unlockable mitral valve clip and delivery system

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112656546A (en) * 2020-12-25 2021-04-16 上海易桥医疗器械有限公司 Valve clamping device and valve clamping system

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112656546A (en) * 2020-12-25 2021-04-16 上海易桥医疗器械有限公司 Valve clamping device and valve clamping system
WO2022134438A1 (en) * 2020-12-25 2022-06-30 上海易桥医疗器械有限公司 Valve clamp and valve clamping system

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