A kind of valve clamping systemTechnical field
The utility model relates to a kind of valve clamping systems more particularly to a kind of for treating the valve of heart valve regurgitationClamping system.
Background technique
Bicuspid valve is attached to the two panels valve (as shown in Figure 1) of left atrioventricular orifice periphery, is connected in papillary muscle by means of chordae tendineae, there is preventionThe blood of left ventricle flows back to the effect of atrium sinistrum.
Mitral regurgitation (MR) is organic or function occurs due to mitral valve leaflet and its dependency structure to sexually revise to lead to twoLeaf coincide bad before and after cusp, and blood flow flows backward to atrium sinistrum from left ventricle, causes a series of pathophysiological change.Serious MR meetingCause left room to expand, eventually leads to left systolic heart failure obstacle and heart failure, while left atrial pressure also increases because of refluxGreatly, Left atrium enlargement, atrial fibrillation and pulmonary hypertension are easy to cause.MR prognosis is poor, has symptom and non-row operator annual death rate5% or so, and there is serious 5 annual death rate of heart failure person up to 60%.Meanwhile MR is also one of most common heart disease.According to systemMeter, the disease incidence more than 65 and 75 years old crowd is respectively 6.4% and 9.3%.With economic society development and population it is oldAge, the disease incidence of mitral regurgitation are in the situation obviously risen.
Clinical test shows that drug therapy can only improve patient symptom, and cannot extend survival of patients or opportunity of operation.OutsideSection's surgical valve reparation or displacement technique are considered as the standard treatments of the disease, have been shown to reduction of patient symptom andExtend its service life.However, surgical operation has the shortcomings that wound is big, postoperative pain is obvious, it is slow to restore, risk is high, in addition, someThere are out chest medical history, poor heart function at advanced age and merge the infull patient of multi-organ function often since surgical risk is refused greatlyExhausted surgical operation.Therefore, researching and developing minimally invasive, low-risk, treatment MR intervention therapeutic apparatus has great social profit and cityField demand.In recent years, as valve interventional therapeutic technique obtains breakthrough development, the intervention apparatus of MR has become the country at presentOne of the emphasis direction of outer cardiovascular devices research and development.
Wherein, the valve clamp instrument that foundation surgical valve edge researches and develops edge suturing skill principle is because of safetyHeight, technical principle are simple, feasibility is big at present most by certainly.Surgery valve edge is as shown in the figure to edge suturing skill principle: two pointsWhen valve reflux, two leaflet edges of paradoxical expansion can not pairing closing there is gap, cause the blood flow of left ventricle to return from gapGo back to atrium sinistrum；Surgery edge sutures by two leaflet edge intermediate point sutures of bicuspid valve, so that when paradoxical expansion between leaflet edgeGap becomes two apertures by a macropore, so that mitral regurgitation (Fig. 2 a) is reduced, and when diastole mitral valve openFlow into left ventricle blood flow again unaffected (Fig. 2 b).The minimally invasive intervention apparatus of unique granted listing treatment MR is Evalve in the worldThe MitraClip of company is exactly a kind of valve jaw device.But it contains complicated control system, the cost of production and productionAlso very high；The instrument needs finally to reach left ventricle through vein, atrium dextrum, atrial septum, atrium sinistrum during operation, and it is again long that road enters approachMany places bending again, therefore surgical procedure is extremely complex, and doctor needs fine tuning transportation system camber repeatedly, direction, horizontal position, hangs downStraight depth can just clamp valve after reaching ideal position, therefore doctor is frequently necessary to take a long time, and could complete a handArt, this disadvantage are denounced deeply.
Therefore, those skilled in the art is dedicated to developing a set of valve clamping system, using easy transportation systemValve clamping machine is accurately delivered to clamping position, quick, effective, safety and at low cost completion valve clamping.
Utility model content
In view of the above drawbacks of the prior art, the technical problem to be solved by the utility model is to provide a kind of valve foldersValve clamping machine is accurately delivered to clamping position using easy transportation system by collaboration system, it is quick, effective, safe and it is low atIt is local to complete valve clamping.Valve clamping system disclosed by the utility model includes:
Catheter sheath with first through hole；
Expander with the second through-hole, second through-hole and its outer wall are able to enter the first through hole, and describedTwo through-hole internal diameters are suitable for penetrating seal wire, and the axial length of second through-hole is greater than the axial length of the first through hole；
Across valve device, across the valve device include that outer diameter is less than the shaft of the first through hole internal diameter and has elasticityAcross valve head, across the valve head is set to described shaft one end, and the shaft length is greater than the axial length of the first through hole；
Conveyer, described conveyer one end are provided with delivery pipe, and the delivery pipe has third through-hole, and the delivery pipeOne end is detachably connected with close ring, and the axial length of the delivery pipe is greater than the axial length of the catheter sheath；
Push rod, at least part push rod is able to enter the third through-hole, and it is logical to be able to enter the thirdRod segment length in hole is greater than the axial length of the third through-hole；
Loader, the loader have fourth hole, and the fourth hole is suitable for accommodating at least part conveyingThe outer wall dimension of pipe, at least part fourth hole is able to enter in the first through hole；
First nip part and the second nip part, first nip part have at least two first clamping arms, instituteState the second clamping arm that the second nip part has corresponding number, corresponding second folder of each first clamping armClosing arm can be combined to a pair of of fixture；First nip part is suitable for being detachably connected with the push rod distal end, and described secondNip part is suitable for being slidably connected with the push rod, and the close ring distal end is suitable for removable with second nip part proximal endUnload connection.
Further, further include puncture sheath, the puncture sheath have internal diameter be suitable for accommodating the shaft and it is described acrossValve head, outer diameter are adapted to enter into the pipeline section of the first through hole.
Further, the conveyer further includes Y type haemostatic valve, the Y type haemostatic valve be set to the conveyer different fromOne end of the delivery pipe.
Further, when the expander is completely into the first through hole, the first through hole 3-8 cm can be stretched out.
Further, it is seamlessly transitted between the expander tube body and the catheter sheath tube wall.
Further, the conveyer further includes operation handle, and the delivery pipe and the closure ring are tied using silk threadBundle mode is fixed at the operation handle.
Further, second nip part and the push rod can occur at a distance from opposite slide as 15-45 mm.
Further, the loader length is 5-15cm, and the delivery tube is 45-55cm, and the pusher is longDegree is 80-90cm.
Further, the close ring distal end is respectively arranged with the interior spiral shell worked in coordination with second nip part proximal endLine and external screw thread, second nip part have the fixation tooth with the screw-internal thread fit.
Further, further include storage box, for place completely the catheter sheath, the expander, across the valve device,The conveyer, the loader and the push rod.
In the utility model, the concept of " proximal end " " distal end " is referred both to during valve surgery, according to it usually usedJudge in the process with the relative position of operator.Wherein, proximal end refers to close to one end of operator, distally refers to remoteOne end from operator.In addition, the first nip part refers to the upper folder for being located at distal end in surgical procedure in the utility model,Second nip part refers to the lower folder positioned at proximal end.
Technical effect
The a series of conveying such as catheter sheath, valve clamping machine are completed jointly 1. working in coordination using components multiple in systemThe surgical procedures such as assembly, conveying and clamping.
2. after assembled in vitro, can disposably convey each nip part to specific bit using the cooperation of push rod and delivery pipeIt sets.
3. the second nip part can slide in push rod, so that operator can fix up and down in useThe clamping position pressed from both sides up and down is freely adjusted before folder, avoids traditional clamping machine because unadjustable, once clamping fault can not repairMultiple problem.
4. close ring and delivery pipe are fixed at operation handle using silk thread, it, can be in operation handle after completing clampingPlace cuts and extracts silk thread out, separates delivery pipe with closure interannular, this operates in external progress, simple and convenient.
5. prepare flexible across valve head using marmem, when conveying can will across valve head be retracted to puncture sheath orTo facilitate conveying in the pipeline of other component.
Make furtherly below with reference to technical effect of the attached drawing to the design of the utility model, specific structure and generationIt is bright, to be fully understood from the purpose of this utility model, feature and effect.
Detailed description of the invention
Fig. 1 is cardiac anatomy schematic diagram；
Surgery edge is to edge suturing skill schematic diagram when Fig. 2 a is mitral valve closure；
Surgery edge is to edge suturing skill schematic diagram when Fig. 2 b is mitral valve open；
Fig. 3 is that catheter sheath in one preferred embodiment of the utility model, the structure of expander and loader and connection are closedIt is schematic diagram；
Fig. 4 is the structural schematic diagram across valve device in Fig. 3 embodiment；
Fig. 5 is the structural schematic diagram of conveyer in Fig. 3 embodiment；
Fig. 6 is the structural schematic diagram of close ring in Fig. 3 embodiment；
Fig. 7 is that conveyer in Fig. 3 embodiment, push rod, the first nip part, the external mounting structure of the second nip part showIt is intended to；
Fig. 8 is the structural schematic diagram of the first nip part in Fig. 3 embodiment；
Fig. 9 is the structural schematic diagram of the second nip part in Fig. 3 embodiment；
Figure 10 is the structural schematic diagram after the completion of implanted component clamping.
Appended drawing reference: 1- catheter sheath, 2- loader, 3- expander, across the valve device of 4-, across the valve head of 401-, 402- shaft, 5-Conveyer, 501- delivery pipe, 502- operation handle, 503-Y type haemostatic valve, 6- close ring, 601- internal screw thread, the first clamping of 7-Component, the second nip part of 8-, 801- external screw thread, 9- push rod, the atrium sinistrum 1001-, 1002- left ventricle, 1003- edge is to edgeSuture.
Specific embodiment
The embodiments of the present invention are described below in detail, examples of the embodiments are shown in the accompanying drawings, wherein from beginningSame or similar element or element with the same or similar functions are indicated to same or similar label eventually.Below by ginsengThe embodiment for examining attached drawing description is exemplary, it is intended to for explaining the utility model, and should not be understood as to the utility modelLimitation.
In the description of the present invention, it should be understood that term " center ", " longitudinal direction ", " transverse direction ", " length ", " widthDegree ", " thickness ", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom" "inner", "outside", " suitableThe orientation or positional relationship of the instructions such as hour hands ", " counterclockwise " is to be based on the orientation or positional relationship shown in the drawings, merely to justIn description the utility model and simplify description, rather than the device or element of indication or suggestion meaning there must be specific sidePosition is constructed and operated in a specific orientation, therefore should not be understood as limiting the present invention.
In addition, term " first ", " second " are used for descriptive purposes only and cannot be understood as indicating or suggesting relative importanceOr implicitly indicate the quantity of indicated technical characteristic.Define " first " as a result, the feature of " second " can be expressed orImplicitly include one or more of the features.The meaning of " plurality " is two or two in the description of the present invention,More than, unless otherwise specifically defined.
In the present invention unless specifically defined or limited otherwise, term " installation ", " connected ", " connection ", " GuIt is fixed " etc. terms shall be understood in a broad sense, for example, it may be being fixedly connected, may be a detachable connection, or be integrally connected；It canTo be mechanical connection, it is also possible to be electrically connected；It can be directly connected, can also can be indirectly connected through an intermediaryConnection inside two elements.For the ordinary skill in the art, above-mentioned term can be understood as the case may beConcrete meaning in the present invention.
In the present invention unless specifically defined or limited otherwise, fisrt feature the "upper" of second feature or it"lower" may include that the first and second features directly contact, and also may include that the first and second features are not direct contacts but lead toCross the other characterisation contact between them.Moreover, fisrt feature includes above the second feature " above ", " above " and " above "One feature is right above second feature and oblique upper, or is merely representative of first feature horizontal height higher than second feature.First is specialSign includes fisrt feature right above second feature and oblique upper under the second feature " below ", " below " and " below ", or onlyIndicate that first feature horizontal height is less than second feature.
A kind of valve clamping system is present embodiments provided, which includes operating member, transfer unit, functionEnergy component and implanted component are all made of storage box and uniformly hold except disposable implanted component, use convenient for operation,In: operating member includes conveyer 5 and push rod；Transfer unit includes catheter sheath 1, puncture sheath and loader 2；Functional component packetInclude expander 3 and across valve device 4；First nip part 7, the second nip part 8 and this three component of close ring 6 are implanted component,It is Permanent implantation human body after the completion of implantation, therefore, which generallys use nontoxic marmem production, simultaneouslyIts excellent elasticity can reduce component in the course of surgery to the damage of organ-tissue, while closely complete to valveClamping.
Below in conjunction with its specifically used method of each component during surgery, the structure and matching relationship of each component are introduced.
It is described below operation is how to convey valve clamping machine into human body using the system, completes clamping movement and mostTransportation system is withdrawn from eventually.
First, cut the left chest the 4th of patient patient or the 5th intercostal 4-6cm, the apex of the heart position of exposure heart, at the apex of the heartCarry out pocket sewing.It is punctured again with puncture needle at pocket center and enters left ventricle, the mesoporous along puncture needle is sent into seal wire, and extraction is wornPricker, puncture needle are the standing tool of operating room, and there is no need to be included in the clamping system.
The second, catheter sheath 1 and expander 3 are sent into along seal wire.As shown in figure 3, the figure shows catheter sheath 1, expander 3 withAnd the connection relationship of 2 three of loader, wherein catheter sheath 1 is tube-like piece, and pore is first through hole, which canThe loading pipe of 2 bottom righthand side of loader is allowed to be inserted, the pore of the loading pipe is fourth hole, and internal diameter is sufficient to accommodate expansionThe expansion of device 3 is managed and all multi-parts such as the delivery pipe 501 of conveyer 5, therefore, in the course of surgery, makees using loader 2Each operating member is accepted for the proximal end of transfer unit, and is conducted into the catheter sheath 1 of distal end.
Expander 3 and catheter sheath 1 can be combined in the present embodiment, i.e., expander 3 can pass through loader 2It is inserted into catheter sheath 1, expander 3 has expansion pipe, and pore is the second through-hole, and internal diameter is suitable for penetrating seal wire.In addition, fromFrom the point of view of axial length, expander 3 is longer than catheter sheath 1, about stretching catheter sheath 13-8cm, and the length of catheter sheath 1 needs 20-35cm.ExpansionIt should accomplish that transition is smooth between 3 tube body of device and the tube wall of catheter sheath 1, in this way, catheter sheath 1 and expander 3 will not when passing through cardiac muscleScrape injured tissue.When the distal end of catheter sheath 1 determines below intra-ventricle, mitral level, expander 3, loader 2 are extractedAnd seal wire, it leaves catheter sheath 1 and is connect with ventricle.
Third, across the valve step in order to realize 1 distal end of catheter sheath need to be sent into across valve device 4 along catheter sheath 1.Across valve device 4For structure as shown in figure 4, across valve device 4 has across valve head 401 and shaft 402, across valve head 401 is closed using with hyperelastic NiTiGold preparation can compress into the puncture sheath of 6-8F (puncture sheath is standing tool in operating room, about long 10cm).Due to not401 size of across valve head of contraction state is typically larger than puncture sheath bore, therefore when operation, shaft 402 is first inserted into puncture sheathGuan Zhong is greater than puncture sheath length of tube since shaft 402 is about 50-60cm, when across valve head 401, which touches, punctures sheath, if continuingShaft 402 is pulled, across the valve contraction of head 401 is eventually entered into using the binding force for puncturing sheath and punctures in sheath；Again will laterPuncture sheath is inserted into catheter sheath 1, and across valve device 4 is sent in continuation inward.When valve is passed through across the valve ball in across valve 4 head of device before and after the bicuspid valve,Into after atrium sinistrum, continue to be sent into catheter sheath 1 inward, when 1 head of catheter sheath in atrium sinistrum when, extract across valve 4 He of devicePuncture sheath.
4th, assembled in vitro.As shown in figure 5,5 distal end of conveyer is delivery pipe 501, pore is the structure of conveyer 5Third through-hole, push rod 9 are rod-like element, can enter the third through-hole, and 2 length of loader is 5-15 cm, 501 length of delivery pipeFor 45-55cm, pusher length is 80-90cm.501 distal end of delivery pipe is equipped with close ring 6,6 structure of close ring such as Fig. 6 instituteShow, distal end has internal screw thread 601.5 proximal end of conveyer is also equipped with Y type haemostatic valve 503.
The first nip part 7, the second nip part 8 after being installed, 501 structure of delivery pipe are as shown in Figure 7, whereinFirst nip part 7, the structure difference of the second nip part 8 are as Figure 8-9,7 proximal end of the first nip part and push rod 9It is threadedly coupled, the second nip part 8 is placed on 9 body of rod surface of push rod, and proximal end is provided with external screw thread 801, can be with delivery pipe 501Internal screw thread 601 in distal end close ring 6 is cooperatively connected, in addition, the proximal end of 8 clamp arm of the second nip part is again provided with clip tooth,Therefore the opening angle that can be further constrained 8 clamp arm of the second nip part using the internal screw thread 601 in close ring 6 simultaneously, is playedThe effect collapsed clamp arm, be tightly fastened nip part.
Steps are as follows for assembled in vitro in operation: the delivery pipe 501 in conveyer 5 being inserted into loader 2, then by push rod 9It is inserted into delivery pipe 501.There is hole between 501 distalmost end of delivery pipe and close ring 6, by the way of silk thread perforation binding, finally tiesIt beats at operation handle 502.The second nip part 8 is put into push rod 9 again, and slides to bottom along 9 surface of push rod, is pushed9 distal end of bar is threadedly coupled with the first nip part 7 again.Second nip part, 8 proximal end is connect with 6 distal threads of close ring again, mostFolder is taken in loader 2 up and down at last.
5th, loader 2 is connected with catheter sheath 1.The push operation handle 502 in heart, until the first nip part7, the second nip part 8 releases in atrium sinistrum.Adjust the first nip part 7, the second nip part 8 is opened and closed with bicuspid valveDirection is vertical, and catheter sheath 1 of dropping back makes the first nip part 7, the second nip part 8 respectively in valve two sides, above pushes away the first folderComponent 7 is closed, so that the second nip part 8 is captured valve, then pull down the first nip part 7, presss from both sides the first nip part 7, secondIt closes 8 clamp arm of component and clamps valve, then above push away close ring 6, collapse left and right clamp arm and enter close ring 6, final clamping mode is as schemedShown in 10.
6th, push rod 9 is screwed out, exits pusher.Knot is cut at operation handle 502, extracts silk thread out,Make to separate between delivery pipe 501 and close ring 6.Withdraw from conveyer 5, catheter sheath 1, loader 2.
7th, pocket is closed.Close chest.Operation is completed.
The preferred embodiments of the present invention have been described in detail above.It should be appreciated that the ordinary skill people of this fieldMember according to the present utility model can conceive without creative work makes many modifications and variations.Therefore, all this technology necksTechnical staff passes through logic analysis, reasoning or limited reality according to the design of the utility model on the basis of existing technology in domainAvailable technical solution is tested, it all should be within the scope of protection determined by the claims.