CN109846579B - Clamp, valve annulus clamp assembly, valve annulus repair system and use method - Google Patents
Clamp, valve annulus clamp assembly, valve annulus repair system and use method Download PDFInfo
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- CN109846579B CN109846579B CN201811304539.0A CN201811304539A CN109846579B CN 109846579 B CN109846579 B CN 109846579B CN 201811304539 A CN201811304539 A CN 201811304539A CN 109846579 B CN109846579 B CN 109846579B
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- 230000008439 repair process Effects 0.000 title claims abstract description 15
- 238000000034 method Methods 0.000 title abstract description 15
- 230000007246 mechanism Effects 0.000 claims abstract description 119
- 229910052751 metal Inorganic materials 0.000 claims description 13
- 239000002184 metal Substances 0.000 claims description 13
- 229910000684 Cobalt-chrome Inorganic materials 0.000 claims description 6
- WAIPAZQMEIHHTJ-UHFFFAOYSA-N [Cr].[Co] Chemical compound [Cr].[Co] WAIPAZQMEIHHTJ-UHFFFAOYSA-N 0.000 claims description 6
- 239000010952 cobalt-chrome Substances 0.000 claims description 6
- 239000000463 material Substances 0.000 claims description 6
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 6
- 239000010935 stainless steel Substances 0.000 claims description 6
- 229910001220 stainless steel Inorganic materials 0.000 claims description 6
- 210000001519 tissue Anatomy 0.000 description 41
- 201000001943 Tricuspid Valve Insufficiency Diseases 0.000 description 10
- 206010044640 Tricuspid valve incompetence Diseases 0.000 description 9
- 210000000591 tricuspid valve Anatomy 0.000 description 9
- 230000006378 damage Effects 0.000 description 5
- 230000000694 effects Effects 0.000 description 4
- 210000005241 right ventricle Anatomy 0.000 description 4
- 210000003462 vein Anatomy 0.000 description 4
- 230000007797 corrosion Effects 0.000 description 3
- 238000005260 corrosion Methods 0.000 description 3
- 238000013016 damping Methods 0.000 description 3
- 239000012528 membrane Substances 0.000 description 3
- 210000005245 right atrium Anatomy 0.000 description 3
- 210000001631 vena cava inferior Anatomy 0.000 description 3
- 210000002620 vena cava superior Anatomy 0.000 description 3
- 229910000831 Steel Inorganic materials 0.000 description 2
- 230000009471 action Effects 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 230000017531 blood circulation Effects 0.000 description 2
- 210000002808 connective tissue Anatomy 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 239000000835 fiber Substances 0.000 description 2
- 230000014759 maintenance of location Effects 0.000 description 2
- 239000010959 steel Substances 0.000 description 2
- LXEYJKWEVVFQMK-UHFFFAOYSA-N [Ti].[Ti].[Ni].[Ni] Chemical compound [Ti].[Ti].[Ni].[Ni] LXEYJKWEVVFQMK-UHFFFAOYSA-N 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 230000000747 cardiac effect Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000004087 circulation Effects 0.000 description 1
- 230000008602 contraction Effects 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 210000002837 heart atrium Anatomy 0.000 description 1
- 230000010247 heart contraction Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000001338 necrotic effect Effects 0.000 description 1
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 238000010992 reflux Methods 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
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Abstract
The invention relates to the field of medical equipment, and provides a clamp, a valve annulus clamp assembly, a valve annulus repair system and a use method, wherein the clamp comprises the following components: a clamping mechanism and a locking mechanism; the clamping mechanism comprises: the first clamping arm and the second clamping arm are opposite and are naturally opened; the first clamping arm is provided with a first flexible meshing part, and the second clamping arm is provided with a second flexible meshing part; the locking mechanism includes: the first plate and the second plate are oppositely arranged; the first clamping arm is provided with a first accommodating groove for being inserted by the first plate, and the second clamping arm is provided with a second accommodating groove for being inserted by the second plate; the first plate and the second plate are used for closing the first clamping arm and the second clamping arm after being respectively inserted into the first accommodating groove and the second accommodating groove, and fixing the first clamping arm and the second clamping arm.
Description
Technical Field
The invention relates to the field of medical equipment, in particular to a clamp, a valve annulus clamp assembly, a valve annulus repair system and a use method.
Background
The tricuspid valve is positioned at the right atrium and the right ventricle opening, is formed by a fiber support ring formed by dense connective tissue and three triangular valve leaves attached on the fiber support ring, and is subjected to periodical motion change of three-dimensional form and size along with the cardiac cycle, and the tricuspid valve is incompletely closed, namely, the tricuspid valve regurgitation is a disease in which a space is formed between the valve leaves due to incomplete closure in the process that three valve leaves meet each other to close a valve hole in the right ventricle systolic period, and blood flow is caused to flow back from the right ventricle to the right atrium.
The tricuspid regurgitation is mainly treated by surgery, and the correction treatment is performed by opening the chest and cutting the heart and suturing the valve or by annularly contracting the valve annulus, but the operation method is high in invasiveness and risk because the heart beating is stopped during the operation and the blood is subjected to extracorporeal circulation by means of an artificial heart-lung machine. The minimally invasive treatment method is low in invasiveness and low in operation risk, but only exists in a theoretical stage at present, and no actual product is available.
Disclosure of Invention
It is an aim of embodiments of the present invention to provide a clip, valve annulus clip assembly and valve annulus repair system and method of use that can treat tricuspid regurgitation by minimally invasive methods.
To solve the above technical problems, embodiments of the present invention provide a clamp, a valve annulus clamp assembly, a valve annulus repair system and a method of using the same, the clamp comprising: a clamping mechanism and a locking mechanism; the clamping mechanism comprises: the first clamping arm and the second clamping arm are opposite and are naturally opened; the first clamping arm is provided with a first flexible meshing part, and the second clamping arm is provided with a second flexible meshing part;
the locking mechanism includes: the first plate and the second plate are oppositely arranged;
the first clamping arm is provided with a first accommodating groove for being inserted by the first plate, and the second clamping arm is provided with a second accommodating groove for being inserted by the second plate;
the first plate and the second plate are used for closing the first clamping arm and the second clamping arm after being respectively inserted into the first accommodating groove and the second accommodating groove, and fixing the first clamping arm and the second clamping arm.
In addition, embodiments of the present invention also provide a valve annulus clamp assembly comprising: a support member, a jig as described above; the support member is disposed at an opposite position of the clamping mechanism for being gripped by the first and second clamping arms of the clamping mechanism.
In addition, embodiments of the present invention also provide a valve annulus clamp assembly comprising: a clamp and a support member;
the clamp comprises: a clamping mechanism and a locking mechanism;
the clamping mechanism comprises: the first clamping arm and the second clamping arm are opposite and are naturally opened;
the locking mechanism part is arranged outside the first clamping arm and the second clamping arm, is connected with the first clamping arm and the second clamping arm, can longitudinally move along a first direction and is finally fixed at a first position, so that the first clamping arm and the second clamping arm are closed;
the support component is arranged at a position opposite to the clamping mechanism and is used for being clamped by the first clamping arm and the second clamping arm of the clamping mechanism.
In addition, embodiments of the present invention also provide a valve annulus repair system comprising: a delivery device, a valve annulus clamp assembly as described above;
the conveying device comprises:
a delivery tube for receiving and delivering the valve annulus clamp assembly;
the first control piece is inserted into the sleeve and used for driving the clamping mechanism to move along the axial direction of the conveying pipe;
the second control piece is inserted into the conveying pipe and used for driving the locking mechanism to move along the axial direction of the conveying pipe;
the auxiliary supporting rod is inserted into the conveying pipe and detachably connected with the supporting component, and is used for driving the supporting component to move along the axial direction of the conveying pipe;
the auxiliary supporting rod is a flexible rebound part and is used for returning to an original shape to bring the supporting part to a position opposite to the clamping mechanism after the supporting part is sent out of the conveying pipe.
In addition, the embodiment of the invention also provides a using method of the valve annulus repair system, which comprises the following steps:
implanting the delivery tube housing the valve annulus clamp assembly into a heart through a vein;
the first control piece is adopted to convey the first clamping arm and the second clamping arm of the clamping mechanism from the conveying pipe to the position above the valve annulus, and the first control piece is naturally opened;
using an auxiliary support rod to convey the support part from the conveying pipe to the lower part of the valve annulus, and after the support part is conveyed out of the conveying pipe, the auxiliary support rod returns to an original shape to bring the support part to a position opposite to the clamping mechanism;
pulling back the supporting component by adopting an auxiliary supporting rod, so that the supporting component jacks up partial tissues to be meshed of the valve annulus until the partial tissues to be meshed are jacked up between the first flexible meshed part and the second flexible meshed part;
the second control piece is adopted to push the locking mechanism forwards until the first plate and the second plate are respectively inserted into the first accommodating groove and the second accommodating groove, so that the first flexible occluding part and the second flexible occluding part occlude partial tissues jacked by the supporting part;
and (3) disconnecting the auxiliary supporting rod from the supporting component, and taking the conveying device out of the heart through veins.
Compared with the prior art, the embodiment of the invention has the advantages that the first clamping arm and the second clamping arm are naturally opened, and partial tissues of the valve annulus are meshed through the first flexible meshing part and the second flexible meshing part, so that the valve annulus is contracted, the space between adjacent valves is reduced, and the blood is prevented from flowing back to the atrium. And after the first flexible occluding part and the second flexible occluding part occlude the tissue of the annular part of the valve, the first plate and the second plate are respectively inserted into the first accommodating groove and the second accommodating groove, the first clamping arm and the second clamping arm are closed, and the first clamping arm and the second clamping arm are fixed, so that the first flexible occluding part and the second flexible occluding part can be prevented from being deviated, the minimally invasive treatment of the tricuspid valve can be realized, and the minimally invasive treatment device has strong practicability and can be put into clinical practice. In addition, in the valve annulus clamp assembly provided by the invention, the part to be clamped is propped between the first flexible occlusion part and the second occlusion part through the support part, so that the part to be clamped of the valve annulus is accurately clamped, and the annular contraction of the valve annulus can be effectively realized. In addition, in the valve annulus repair system provided by the invention, the valve annulus clamp assembly is stored and conveyed through the conveying pipe, so that the valve annulus clamp assembly can be implanted into the heart through the superior vena cava or the inferior vena cava in a closed state. And moreover, the first control piece, the second control piece and the auxiliary supporting rod drive all parts of the valve annulus clamp assembly to move, so that minimally invasive treatment on tricuspid regurgitation can be effectively realized. In addition, the using method of the valve annulus repair system provided by the invention is convenient to operate and high in practicability, and the valve annulus repair system is used for carrying out minimally invasive treatment on the tricuspid regurgitation of patients.
In addition, the first clamping arm further includes: the first flexible arm is used for connecting the first flexible occluding part and the first arm body in series, and the first accommodating groove is respectively formed in the first arm body and the first flexible occluding part; the second clamp arm includes: the second flexible arm is used for connecting the second flexible occluding part and the second arm body in series; the second accommodating groove is respectively arranged on the second arm body and the second flexible occluding part.
In addition, the first flexible arm and the second flexible arm are both memory metal pieces; alternatively, the first flexible arm and the second flexible arm are each a multi-module chain structure. Thus allowing the first flexible arm and the second flexible arm to open naturally after being fed out of the delivery tube.
In addition, the first flexible engaging part is a first tooth-shaped structural part, and the second flexible engaging part is a second tooth-shaped structural part; and when the first flexible arm and the second flexible arm are both multi-module chain structures, the first toothed structure comprises: a first biting tooth disposed on at least one module in the first flexible arm; the second toothed structure comprises: a second biting tooth disposed on at least one module in the second flexible arm.
In addition, after the first flexible occluding part and the second flexible occluding part are mutually occluded, at least one cavity is formed between the first flexible occluding part and the second flexible occluding part. Thus, the damage of the annulus tissue caused by the overlarge biting force of the first flexible biting part and the second flexible biting part when the first flexible biting part and the second flexible biting part are meshed can be avoided.
In addition, the locking mechanism is formed by processing nickel-titanium-nickel-titanium alloy, cobalt-chromium or stainless steel materials. As the nickel-titanium alloy, cobalt-chromium or stainless steel material and other materials have excellent characteristics of wear resistance, corrosion resistance, high damping, super elasticity and the like, the material can be remained in a patient without causing harm to the patient.
In addition, one side of the first plate facing the second plate is provided with a part of a bulge to form a first protruding part, and one side of the second plate facing the first plate is provided with a part of a bulge to form a second protruding part; the first protruding portion and the second protruding portion are disposed opposite to each other.
In addition, the fixture further includes: the stop piece is fixedly connected with the first clamping arm and the second clamping arm respectively; the stop piece is also in sliding connection with the first plate and the second plate along the axial direction of the locking mechanism; the locking mechanism further includes: the connecting piece is arranged opposite to the stop piece and is fixedly connected with the first plate and the second plate respectively; the one side of the stopping piece relative to the connecting piece is a first stopping surface, and the one side of the connecting piece relative to the stopping piece is a second stopping surface.
In addition, the whole locking mechanism is a U-shaped structural member or a C-shaped structural member; the first clamping arm and the second clamping arm are used for entering the inside of the U-shaped structural member or the C-shaped structural member when being closed.
In addition, the support member is a long rod member, and a distal end of the long rod member is larger in cross-sectional diameter than the rest of the long rod member with respect to the clamping mechanism. Therefore, the long rod part is not easy to slide out of the clamping mechanism, and the stability of the clamping mechanism for clamping valve tissues is improved.
Drawings
Fig. 1 is a schematic structural view of a jig in a first embodiment of the present invention;
fig. 2 is a schematic structural view of a clamping mechanism in a first embodiment of the present invention;
fig. 3 is a schematic view of the structure of the locking mechanism in the first embodiment of the present invention;
FIG. 4 is an assembled schematic view of the locking clamping mechanism of the locking mechanism in the first embodiment of the present invention;
FIG. 5 is an exploded view of a clamp assembly according to a second embodiment of the present invention;
FIG. 6 is an assembled schematic view of a clamp assembly of a second embodiment of the invention in use;
FIG. 7 is an exploded view of a clamp assembly according to a third embodiment of the present invention;
fig. 8 is a schematic structural view of a jig in a third embodiment of the invention;
fig. 9 is a schematic structural view of a clamping mechanism in a third embodiment of the present invention;
FIG. 10 is a schematic view of the structure of the lock mechanism lock in the third embodiment of the present invention;
FIG. 11 is an assembled schematic view of a locking clamping mechanism of a locking mechanism in a third embodiment of the invention;
FIG. 12 is an assembled schematic view of a clamp assembly of a second embodiment of the invention in use;
fig. 13 is a schematic structural view of a clamp, a long rod member, and an auxiliary support rod in the fourth embodiment;
fig. 14 is a schematic view showing the structure of a transfer pipe in the fourth embodiment;
FIG. 15 is a cross-sectional view of a valve annulus repair system in a fourth embodiment;
fig. 16 is a flowchart in the fifth embodiment.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the present invention more apparent, embodiments of the present invention will be described in detail below with reference to the accompanying drawings. However, those of ordinary skill in the art will understand that in various embodiments of the present invention, numerous technical details have been set forth in order to provide a better understanding of the present application. However, the technical solutions claimed in the present application can be implemented without these technical details and with various changes and modifications based on the following embodiments. The following embodiments are divided for convenience of description, and should not be construed as limiting the specific implementation of the present invention, and the embodiments may interact in combination without contradiction.
The first embodiment of the invention provides a clamp for clamping an annulus of a tricuspid valve, the tricuspid valve is composed of an annulus composed of compact connective tissue and three valves attached to the annulus, the three valves of a patient with tricuspid regurgitation disease cannot be completely closed to seal the annulus, blood flow can be caused to reflow from a right ventricle to a right atrium, and the clamp in the embodiment can clamp part of the tissue part of the annulus of the tricuspid valve, can effectively contract the annulus, and can realize minimally invasive treatment of tricuspid regurgitation.
As shown in fig. 1, the jig of the present embodiment includes: a clamping mechanism 1 and a locking mechanism 2, wherein the clamping mechanism 1 comprises: a first clamping arm 3 and a second clamping arm 4 which are opposite and naturally open, the first clamping arm 3 having a first flexible engagement portion 33, the second clamping arm 4 having a second flexible engagement portion 43; the first flexible bite 33 and the second flexible bite 43 are used to hold a piece of valve. The locking mechanism 2 is then used to lock the first and second clamping arms 3, 4 so that the first and second flexible abutments 33, 43 can remain permanently clamped against a portion of the tissue of the valve annulus.
In addition, as shown in fig. 3, the lock mechanism 2 includes: the connecting piece 23, the first plate 21 and the second plate 22 of relative setting, the connecting piece 23 connects between first plate 21 and second plate 22, and locking mechanism 2 wholly is U type structure or C type structure. In the present embodiment, the locking mechanism 2 is a U-shaped structure, but the locking mechanism 2 may be a C-shaped structure, and the U-shaped structure is taken as an example in the present embodiment, and the present invention is not limited thereto. As shown in fig. 2, the first holding arm 3 is provided with a first receiving groove 34 into which the first plate 21 is inserted, and the second holding arm 4 is provided with a second receiving groove 44 into which the second plate 22 is inserted. And the first clamping arm 3 and the second clamping arm 4 have elasticity, and when the first plate 21 is inserted into the first accommodating groove 34 and the second plate 22 is inserted into the second accommodating groove 44, as shown in fig. 4, the first clamping arm 3 and the second clamping arm 4 move towards opposite directions, and the first flexible engaging portion 33 and the second flexible engaging portion 43 clamp part of the tissue part of the valve annulus through the relative movement of the first clamping arm 3 and the second clamping arm 4. In addition, when the first plate 21 and the second plate 22 of the locking mechanism 2 are inserted into the first receiving groove 34 and the second receiving groove 44, respectively, the first clamping arm 3 and the second clamping arm 4 may also be locked such that the first flexible occlusion 33 and the second flexible occlusion 43 may remain permanently clamped against a portion of the tissue site of the annulus.
In addition, as shown in fig. 1 and 2, the first clamping arm 3 further includes: the first arm body 31 and the first flexible arm 32, the first flexible arm 32 connects the first arm body 31 and the first flexible engaging portion 33 in series, and the first receiving groove 34 is respectively opened on the first arm body 31 and the first flexible engaging portion 33. Likewise, the second clamping arm 4 further comprises: the second arm body 41 and the second flexible arm 42, and the second flexible arm 42 connects the second arm body 41 and the second flexible engaging portion 43 in series, and the second receiving groove 44 is respectively opened on the second arm body 41 and the second flexible engaging portion 43. Thus, when the first plate 21 and the second plate 2 are inserted into the two first receiving grooves 34 and the two second receiving grooves 44, respectively, the first flexible engaging portion 33 and the second flexible engaging portion 43 can be closed by the clamping action of the first plate 21 and the second plate 22, respectively, and engage a portion of the tissue portion of the valve annulus while being closed. When the first clamping arm 3 and the second clamping arm 4 are fully closed, the clamping mechanism 1 enters the interior of the U-shaped mechanism piece.
Preferably, the first flexible arm 32 and the second flexible arm 42 are each made of a memory metal member having extremely high elasticity and shape retention capability, and the memory metal member is made of nitinol, cobalt chromium or stainless steel materials, which have excellent characteristics of wear resistance, corrosion resistance, high damping, superelasticity, etc., so that the damage to the patient can be reduced when the memory metal member is stored in the patient. Since the memory metal has a property of being able to revert to the original form in the event of any deformation. Thus, when the first flexible arm 32 and the second flexible arm 42 are in a state of being naturally opened and being away from each other without any force being applied thereto. Second, when the first plate 21 and the second plate 22 of the locking mechanism 2 are inserted into the first receiving groove 34 and the second receiving groove 44, respectively, the first flexible arm 32 and the second flexible arm 42 move in opposite directions to each other.
It should be noted that, after the two engaging portions are engaged, at least one cavity is formed between the two engaging portions, so that the acting force exerted by the first flexible engaging portion 33 and the second flexible engaging portion 43 on the engaged tissue portion can be effectively relieved, so as to prevent the clamped tissue from being necrotic due to excessive clamping force.
Meanwhile, in order to make the first flexible engaging portion 33 and the second flexible engaging portion 43 have a better clamping effect on the tissue portion of the annulus, in this embodiment, as shown in fig. 1, the first flexible engaging portion 33 and the second flexible engaging portion 43 may each adopt a tooth-shaped structural member, and the clamping of the tissue portion of the annulus is achieved by the mutual engagement of the two tooth-shaped structural members. Specifically, each tooth-shaped structural member is provided with a plurality of engaging teeth 9, and the engaging teeth 9 on the two tooth-shaped structural members are mutually staggered. Thus, the engaged tissue site is not easily escaped after the engagement of the engagement teeth 9 on the two toothed structures with each other. Further, in order to avoid that the first flexible engaging portion 41 and the second flexible engaging portion 42 do not damage the engaged tissue site after being engaged with each other.
In addition, the first flexible arm 32 and the second flexible arm 42 may also be multi-module chain structures, which have strong deformability, and the chain structures may be formed by sequentially connecting and splicing a plurality of metal modules in series through corresponding belt members, so that the clamping effect on the annular tissue can be achieved correspondingly. When the chain structure is adopted, the two tooth-shaped structural members at least comprise the engaging teeth 9 arranged on one metal module, and the engaging teeth 9 can be respectively arranged on a plurality of metal modules of each flexible arm to form the tooth-shaped structural members for improving the engaging effect on the corresponding tissue parts of the annulus.
Meanwhile, as shown in fig. 2, the clamping mechanism 1 further includes: and a fixedly connected stop 5 connected to the first clamping arm 3 and the second clamping arm 4. Referring to fig. 1 and 3, the stopper 5 is slidably connected to the first plate 21 and the second plate 22 along the axial direction of the locking mechanism 2, and the stopper 5 is slidable in the locking mechanism 2, wherein a side of the stopper 5 facing the connecting piece 23 of the locking mechanism 2 is a first stopper surface 51, and a side of the connecting piece 23 facing the stopper 5 is a second stopper surface 231. The medical staff can push the locking mechanism 2 to move towards the direction approaching the clamping mechanism 1, the connecting piece 23 also moves towards the stop piece 5, and the locking mechanism is a limiting position of the movement of the locking mechanism 2 when the first stop surface 51 and the second stop surface 231 are pushed against each other, and at the moment, the clamping mechanism 1 is completely closed and stored in the locking mechanism 2.
It should be noted that, after the operation, the clamp remains in the heart of the patient, and as a preferred solution, the locking mechanism 2 is made of nickel-titanium alloy, cobalt-chromium or stainless steel, and as shown in fig. 3, a part of the first plate 21 of the locking mechanism 2 facing the second plate 22 protrudes to form a first protruding part 211, and a part of the second plate 22 facing the first plate 21 protrudes to form a second protruding part 212, where the first protruding part 211 is opposite to the second protruding part 212, and when the clamping mechanism 1 is accommodated in the locking mechanism 2, the first protruding part 211 and the second protruding part 212 respectively abut against the first flexible engaging part 33 and the second flexible engaging part 43, so as to maintain the clamping of the tissue part of the valve annulus by the clamping mechanism 1 and prevent the clamping mechanism 1 from sliding out of the locking mechanism 2, thereby achieving the effect of treating the tricuspid valve reflux.
A second embodiment of the present invention provides a clamp assembly for a valve annulus of a tricuspid regurgitation, which comprises a support member and a clamp according to the first embodiment, wherein the support member is positioned opposite to the clamping mechanism 1 as shown in fig. 5, the support member is a long rod member 6, the end 61 of the long rod member 6 is opposite to the clamping mechanism 1, in operation, the long rod member 6 is positioned on the inner side of the valve annulus, the clamp is positioned on the outer side of the valve annulus, the end 61 of the long rod member 6 faces the valve annulus tissue to be lifted, and a medical staff can lift the valve annulus tissue part between the first flexible occlusion part 33 and the second flexible occlusion part 43 by pulling the long rod member 6 outwards, so that the clamping mechanism 1 can clamp the valve annulus tissue conveniently, and the valve annulus is clamped. At the same time, the first flexible occlusion part 33 and the second flexible occlusion part 43 can simultaneously clamp the occluded tissue part and the long rod part 6 together, so that the clamping stability is improved.
Notably, the cross-sectional diameter of the end 61 of the elongate member 6 is greater than the cross-sectional diameter of the remainder of the elongate member 6, and the end 61 of the elongate member 6 is clamped by the first flexible nip 33 and the second flexible nip 43, and the elongate member 6 is less likely to slide out of the clamping mechanism 1 due to the greater cross-sectional diameter of the end 61, further improving the stability of clamping the tissue site.
Through the above, it is easily found that the problem that the tissue part of the valve annulus is relatively flat and smooth and is not easy to be occluded by the clamp is solved by arranging the long rod part 6, so that the risk of minimally invasive treatment is further reduced.
A third embodiment of the present invention provides a membrane valve annulus clamp assembly, as shown in fig. 7, comprising: a clamp and a support member. Wherein, this anchor clamps include: a clamping mechanism 1 and a locking mechanism 2. As shown in fig. 8, the clamping mechanism 1 includes: a first clamping arm 3 and a second clamping arm 4 which are opposite and open naturally. The locking mechanism 2 is partially disposed outside the first clamp arm 3 and the second clamp arm 4, is configured to be connected to the first clamp arm 3 and the second clamp arm 4, is capable of moving longitudinally in a first direction, and is finally fixed to a first position, thereby closing the first clamp arm 3 and the second clamp arm 4. In addition, a support member is placed at a position opposite to the clamping mechanism for being gripped by the first clamping arm 3 and the second clamping arm 4 of the clamping mechanism 1.
Specifically, as shown in fig. 10, the lock mechanism 2 includes: the connecting piece 23, the first plate 21 and the second plate 22 of relative setting, the connecting piece 23 connects between first plate 21 and second plate 22, and locking mechanism 2 wholly is U type structure or C type structure. In the present embodiment, the locking mechanism 2 is a U-shaped structure, but the locking mechanism 2 may be a C-shaped structure, and the U-shaped structure is taken as an example in the present embodiment, and the present invention is not limited thereto. As shown in fig. 9, the first holding arm 3 is provided with a first receiving groove 34 into which the first plate 21 is inserted, and the second holding arm 4 is provided with a second receiving groove 44 into which the second plate 22 is inserted. And the first clamping arm 3 and the second clamping arm 4 have elasticity, and when the first plate 21 is inserted into the first accommodating groove 34 and the second plate 22 is inserted into the second accommodating groove 44, as shown in fig. 11, the first clamping arm 3 and the second clamping arm 4 move towards each other, and the first flexible engaging portion 33 and the second flexible engaging portion 43 clamp a part of tissue part of the valve annulus through the relative movement of the first clamping arm 3 and the second clamping arm 4. In addition, when the first plate 21 and the second plate 22 of the locking mechanism 2 are inserted into the first receiving groove 34 and the second receiving groove 44, respectively, the first clamping arm 3 and the second clamping arm 4 may also be locked such that the first flexible occlusion 33 and the second flexible occlusion 43 may remain permanently clamped against a portion of the tissue site of the annulus.
In addition, as shown in fig. 8 and 9, the first clamping arm 3 further includes: the first arm body 31 and the first flexible arm 32, the first flexible arm 32 connects the first arm body 31 and the first flexible engaging portion 33 in series, and the first receiving groove 34 is respectively opened on the first arm body 31 and the first flexible engaging portion 33. Also, as shown in fig. 8 and 9, the second clamp arm 4 further includes: the second arm body 41 and the second flexible arm 42, and the second flexible arm 42 connects the second arm body 41 and the second flexible engaging portion 43 in series, and the second receiving groove 44 is respectively opened on the second arm body 41 and the second flexible engaging portion 43. Thus, when the first plate 21 and the second plate 2 are inserted into the two first receiving grooves 34 and the two second receiving grooves 44, respectively, the first flexible engaging portion 33 and the second flexible engaging portion 43 can be closed by the clamping action of the first plate 21 and the second plate 22, respectively, and engage a portion of the tissue portion of the valve annulus while being closed. When the first clamping arm 3 and the second clamping arm 4 are fully closed, the clamping mechanism 1 enters the interior of the U-shaped mechanism piece.
Preferably, the first flexible arm 32 and the second flexible arm 42 are made of a memory metal member having extremely high elasticity and shape retention capability, and the memory metal member is made of nickel-titanium alloy, cobalt-chromium or stainless steel, which has excellent characteristics of wear resistance, corrosion resistance, high damping and super elasticity, so that the damage to the patient can be reduced when the memory metal member is stored in the patient. Since the memory metal has a property of being able to revert to the original form in the event of any deformation. Thus, when the first flexible arm 32 and the second flexible arm 42 are in a state of being naturally opened and being away from each other without any force being applied thereto. Second, when the first plate 21 and the second plate 22 of the locking mechanism 2 are inserted into the first receiving groove 34 and the second receiving groove 44, respectively, the first flexible arm 32 and the second flexible arm 42 move in opposite directions to each other.
In addition, the supporting component is located at the opposite position of the clamping mechanism 1, the supporting component is a long rod component 6, the tail end 61 of the long rod component 6 is opposite to the clamping mechanism 1, in operation, as shown in fig. 12, the long rod component 6 is located at the inner side of an annulus, the clamp is located at the outer side of the annulus, the tail end 61 of the long rod component 6 faces to the tissue of the annulus to be jacked up, and a medical staff can jack the tissue part of the annulus between the first flexible occlusion part 33 and the second flexible occlusion part 43 by pulling the long rod component 6 outwards, so that the clamping mechanism 1 can clamp the tissue of the annulus conveniently, and clamp the annulus. At the same time, the first flexible occlusion part 33 and the second flexible occlusion part 43 can simultaneously clamp the occluded tissue part and the long rod part 6 together, so that the clamping stability is improved.
Notably, the cross-sectional diameter of the end 61 of the elongate member 6 is greater than the cross-sectional diameter of the remainder of the elongate member 6, and the end 61 of the elongate member 6 is clamped by the first flexible nip 33 and the second flexible nip 43, and the elongate member 6 is less likely to slide out of the clamping mechanism 1 due to the greater cross-sectional diameter of the end 61, further improving the stability of clamping the tissue site.
Through the above, it is easily found that the problem that the tissue part of the valve annulus is relatively flat and smooth and is not easy to be occluded by the clamp is solved by arranging the long rod part 6, so that the risk of minimally invasive treatment is further reduced.
A third embodiment of the present invention provides a valve annulus repair system for use in a tricuspid regurgitation procedure comprising a delivery device implantable through the superior or inferior vena cava to the heart for delivering the clip assembly to the tricuspid valve for the procedure, and a membrane valve annulus clip assembly as in the second embodiment.
As shown in fig. 13, 14 and 15, the conveying apparatus includes: the conveying pipe 7, the first control piece, the second control piece and the auxiliary supporting rod 8 are arranged in the conveying pipe 7, and a first cavity 71 for accommodating the membrane valve ring clamp assembly and a second cavity 72 for accommodating the auxiliary supporting rod 8 are arranged in the conveying pipe 7. In this embodiment, the first control element and the second control element are both flexible steel wire ropes, and of course, the first control element and the second control element may be other traction elements, and in this embodiment, only flexible steel wire ropes are used as an example, and no specific limitation is made. The first control piece is inserted into the first cavity 71 and detachably connected with the clamping mechanism 1, and is used for driving the clamping mechanism 1 to move along the axial direction of the conveying pipe 7; the second control member is inserted into the first cavity 71 and detachably connected with the locking mechanism 2, and is used for driving the locking mechanism 2 to move along the axial direction of the conveying pipe 7. The first control piece and the second control piece are controlled by medical staff and are used for pushing and pulling the clamping mechanism 1 and the locking mechanism 2, and the clamping operation is performed, so that the clamping mechanism 1 approaches to the tricuspid valve, the valve ring tissue is clamped and the clamping mechanism 1 is locked.
The auxiliary support rod 8 is inserted into the second cavity 72, is detachably connected with the support member, i.e. the long rod member 6, and can drive the long rod member 6 to move along the axial direction of the conveying pipe 7. In this embodiment, first control and fixture 1, second control and locking mechanism 2, stock part 6 and auxiliary stay 8 are connected through the buckle, and the buckle is connected stably and is dismantled conveniently, is convenient for take out of auxiliary stay 8, first control and second control. Meanwhile, as shown in fig. 5, the auxiliary supporting rod 8 is a flexible rebound part, after the medical staff pushes the long rod part 6 out of the conveying pipe 7 through the auxiliary supporting rod 8, the auxiliary supporting rod 8 can rebound to an original shape, the auxiliary supporting rod 8 is hooked after rebound, the long rod part 6 is driven to a position opposite to the clamping mechanism 1, and the medical staff can place the long rod part 6 on the inner side of the tissue to be occluded of the valve annulus by moving the auxiliary supporting rod 8.
After the clamp finishes clamping the valve annulus and the long rod part 6, medical staff can release the connection between the first control part and the clamping mechanism 1 by rotating the first control part, contact the second control part with the connection between the locking mechanism 2 by rotating the second control part, release the connection between the auxiliary support rod 8 and the long rod part 6 by rotating the auxiliary support rod 8, and then take out the conveying pipe 7, the first control part, the second control part and the auxiliary support rod 8.
From the above, it is readily found that the valve annulus clamp assembly can be received and delivered by the passage delivery tube 7, so that the valve annulus clamp assembly can be implanted into the heart from the superior vena cava or inferior vena cava of the human body through the passage delivery tube 7 in the closed state. And moreover, each part of the valve annulus clamp assembly can be driven to move through the first control part, the second control part and the auxiliary supporting rod 8, so that minimally invasive treatment on tricuspid regurgitation can be effectively realized.
A fourth embodiment of the present invention provides a method of using the valve annulus repair system of the third embodiment, as shown in fig. 16, comprising the steps of:
101. implanting the delivery tube housing the valve annulus clamp assembly into the heart through a vein;
102. a first control piece is adopted to convey a first clamping arm and a second clamping arm of the clamping mechanism from the conveying pipe to the upper part of the valve annulus, and the first clamping arm and the second clamping arm are naturally opened;
103. the auxiliary supporting rod is adopted to convey the supporting part from the conveying pipe to the lower part of the valve annulus, and after the supporting part is conveyed out of the conveying pipe, the auxiliary supporting rod is restored to the original shape to bring the supporting part to the relative position with the clamping mechanism;
104. pulling the supporting component back by adopting the auxiliary supporting rod, so that the supporting component jacks up partial tissues to be meshed of the valve annulus until the partial tissues to be meshed are jacked between the first flexible meshed part and the second flexible meshed part;
105. the second control piece is adopted to push the locking mechanism forwards until the first plate and the second plate are respectively inserted into the first accommodating groove and the second accommodating groove, so that the first flexible occluding part and the second flexible occluding part occlude part of tissues jacked by the supporting part;
106. the auxiliary supporting rod and the supporting component are disconnected, and the conveying device is taken out from the heart through veins.
It will be understood by those of ordinary skill in the art that the foregoing embodiments are specific examples of carrying out the invention and that various changes in form and details may be made therein without departing from the spirit and scope of the invention.
Claims (10)
1. A valve annulus clamp assembly, comprising: a clamp and a support member;
the clamp comprises: a clamping mechanism and a locking mechanism;
the clamping mechanism comprises: the first clamping arm and the second clamping arm are opposite and are naturally opened; the first clamping arm is provided with a first flexible occluding part, a first arm body and a first flexible arm, and the first flexible arm is used for connecting the first flexible occluding part and the first arm body in series; the second clamping arm is provided with a second flexible occluding part, a second arm body and a second flexible arm, and the second flexible arm connects the second flexible occluding part and the second arm body in series;
the locking mechanism includes: the first plate and the second plate are oppositely arranged;
the first arm body and the first flexible occluding part are respectively provided with a first accommodating groove for being inserted by the first plate; the second arm body and the second flexible occluding part are respectively provided with a second accommodating groove for being inserted by the second plate; the first plate and the second plate are used for closing the first clamping arm and the second clamping arm after being respectively inserted into the first accommodating groove and the second accommodating groove, and fixing the first clamping arm and the second clamping arm;
the clamping mechanism further comprises: the stop piece is fixedly connected with the first clamping arm and the second clamping arm respectively; the stop piece is respectively connected with the first plate and the second plate in a sliding manner along the axial direction of the locking mechanism;
the locking mechanism further includes: the connecting piece is arranged opposite to the stop piece and is fixedly connected with the first plate and the second plate respectively; the side of the stop piece, which is opposite to the connecting piece, is a first stop surface, and the side of the connecting piece, which is opposite to the stop piece, is a second stop surface;
the support component is arranged at a position opposite to the clamping mechanism and is used for being clamped by the first clamping arm and the second clamping arm of the clamping mechanism.
2. The valve annulus clamping assembly of claim 1, wherein the first flexible arm and the second flexible arm are each a memory metal piece;
alternatively, the first flexible arm and the second flexible arm are each a multi-module chain structure.
3. The valve annulus clamp assembly of claim 2, wherein the first flexible bite is a first toothed structure and the second flexible bite is a second toothed structure;
and when the first flexible arm and the second flexible arm are both multi-module chain structures, the first toothed structure comprises: a first biting tooth disposed on at least one module in the first flexible arm; the second toothed structure comprises: a second biting tooth disposed on at least one module in the second flexible arm.
4. The valve annulus clamp assembly of claim 1, wherein after the first flexible bite portion and the second flexible bite portion are engaged with each other, at least one cavity is further formed between the first flexible bite portion and the second flexible bite portion.
5. The valve annulus clamp assembly of claim 1, wherein the locking mechanism is made of nickel-titanium alloy or cobalt-chromium.
6. The valve annulus clamp assembly of claim 1, wherein the locking mechanism is made of stainless steel material.
7. The valve annulus clamp assembly of claim 1, wherein a side of the first plate facing the second plate has a portion protruding to form a first protrusion, and a side of the second plate facing the first plate has a portion protruding to form a second protrusion; the first protruding portion and the second protruding portion are disposed opposite to each other.
8. The valve annulus clamp assembly of claim 1, wherein the locking mechanism is integrally a U-shaped structural member or a C-shaped structural member; the first clamping arm and the second clamping arm are used for entering the inside of the U-shaped structural member or the C-shaped structural member when being closed.
9. The valve annulus clamp assembly of claim 1, wherein the support member is a long rod member having a distal end opposite the clamping mechanism, the long rod member distal end having a cross-sectional diameter that is greater than a cross-sectional diameter of a remainder of the long rod member.
10. A valve annulus repair system, comprising: a delivery device, the valve annulus clamp assembly of any of claims 1-9;
the conveying device comprises:
a delivery tube for receiving and delivering the valve annulus clamp assembly;
the first control piece is inserted into the conveying pipe and used for driving the clamping mechanism to move along the axial direction of the conveying pipe;
the second control piece is inserted into the conveying pipe and used for driving the locking mechanism to move along the axial direction of the conveying pipe;
the auxiliary supporting rod is inserted into the conveying pipe and detachably connected with the supporting component, and is used for driving the supporting component to move along the axial direction of the conveying pipe;
the auxiliary supporting rod is a flexible rebound part and is used for returning to an original shape to bring the supporting part to a position opposite to the clamping mechanism after the supporting part is sent out of the conveying pipe.
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| CN201811304539.0A CN109846579B (en) | 2018-11-04 | 2018-11-04 | Clamp, valve annulus clamp assembly, valve annulus repair system and use method |
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| CN201811304539.0A CN109846579B (en) | 2018-11-04 | 2018-11-04 | Clamp, valve annulus clamp assembly, valve annulus repair system and use method |
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| CN109846579B true CN109846579B (en) | 2024-03-15 |
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| CN110353821B (en) * | 2019-06-20 | 2023-08-01 | 上海汇禾医疗科技股份有限公司 | Clamping device and clamping assembly |
| CN110338857B (en) * | 2019-08-02 | 2024-03-29 | 上海纽脉医疗科技有限公司 | Clamp holder for repairing valve leaflet |
| EP4009905B1 (en) * | 2019-08-05 | 2023-10-04 | Croivalve Ltd. | Apparatus for treating a defective cardiac valve |
| CN113317910A (en) * | 2021-05-17 | 2021-08-31 | 上海汇禾医疗科技有限公司 | Mitral annuloplasty system and method of operation thereof |
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Effective date of registration: 20200828 Address after: Room 303-1, building 5, 1158 Jiuting Central Road, Jiuting Town, Songjiang District, Shanghai, 201615 Applicant after: Shanghai Huihe Medical Technology Co.,Ltd. Address before: Room 1204, 12/F, 525 Chengyin Road, Baoshan District, Shanghai, 2004 Applicant before: SHANGHAI HUIZHI MEDICAL TECHNOLOGY Co.,Ltd. |
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Address after: Room 303, building 5, No. 1158, Jiuting Central Road, Jiuting Town, Songjiang District, Shanghai 201615 Applicant after: Shanghai Huihe Medical Technology Co.,Ltd. Address before: 201615 room 303-1, building 5, no.1158, Jiuting Central Road, Jiuting Town, Songjiang District, Shanghai Applicant before: Shanghai Huihe Medical Technology Co.,Ltd. |
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