A kind of prosthesis delivery system with positioning functionTechnical field
The invention belongs to medical instruments field, it is related to a kind of prosthesis delivery system with positioning function more particularly to onePlant the prosthesis delivery system with positioning function for treating heart valve regurgitation.
Background technique
With the arriving of aging of population, the disease incidence of heart valve disease rises obvious.Especially mitral regurgitation(mitral regurgitation, MR), disease incidence is 5 times of aortic stenosis in patients or more.It is estimated that having in ChinaSevere MR patient more than 10,000,000.MR be changed due to mitral valve leaflet and its structure lead to bicuspid valve before and after leaf coincide notGood, blood is from left ventricle adverse current to atrium sinistrum, so as to cause some symptoms.According to pathogenesis, MR can be divided into primary (device matterProperty) and it is secondary (functionality), about respectively account for 50%.Mild MR patient clinical symptoms can not occur within some time, in advanceAfterwards preferably.Severe MR patient can be with the symptoms such as palpitaition, uncomfortable in chest, out of breath.Acute severe MR patient tolerability is very poor, it is easy to go outExisting death.Clinical research shows that patient symptom can only be improved by drug therapy, and when cannot extend its life span or operationMachine.Surgery valve reparation or displacement technique are acknowledged as the standard method for the treatment of MR, have been shown to patients in remission and prolongIts long life span.But surgical operation therapy has wound is big, post-operative recovery is slow, postoperative pain is obvious, risk is high etc. to lackPoint.Meanwhile there is 50% MR patient because Lower cardiac function, advanced age, there are out the high risk factors such as chest medical history to be not suitable for surgical operationAnd it cannot effectively treat.In recent ten years, fast-developing through conduit bicuspid valve interventional therapeutic technique, especially MitraClipListing be many patients bring hope.It recent studies have shown that, MitraClip is better than medicine to the therapeutic effect of functional refluxObject treatment.In face of huge market, each large enterprises set foot on capital one after another in the ranks that MR is treated.
Just because of this, MR treatment is when just welcoming interventional therapy after experience conventional surgical opens chest and mini-invasive incision operationGeneration.Valvular therapeutic modality is intervened compared to the advantage that traditional treatment has wound small, to the height of unsuitable surgical operationDanger patient brings hope.Although intervening valvular therapeutic modality has many advantages, face compared to traditional treatmentFace many technical problems, such as difficult positioning.Location difficulty brings risk to interventional therapy, in order to obtain clearly image, handIt needs that contrast agent is used for multiple times when art, patient is made to face the harm of contrast agent.Multiple and large dosage of X-ray makes tiring out for patientIt is excessive to count amount of radiation, faces the harm of radiation injury.If because orientation problem cause release implantation object location it is undesirable orPerson is subjected to displacement or even falls off, and patient may face the risk for carrying out traditional thoracotomy again, serious threat to life.So protectingDemonstrate,proving the location technology of implantation material promptly and accurately has great clinical value for intervention operation.
Currently, the listing that uniquely gets the Green Light in the world is Abbott company through intubation intervention instrument for treat MRMitraClip.Edge of its design principle in surgery valve surgery is to edge suturing skill.When the heart contracts, bicuspid valveFront and back leaflet edge can not pairing cause the blood flow of left ventricle from gap location reflux to atrium sinistrum to gap occur.SurgeryEdge to edge technology be by leaflet edge intermediate point suture before and after bicuspid valve so that bicuspid valve becomes two apertures from a macropore,To reduce MR.In actual operation, the control system of MitraClip is complicated, and Operative approch is long and channel is bent more, needs to cureRaw camber, direction, the release depth etc. for finely tuning transportation system repeatedly, can just clamp leaflet by repeatedly attempting, therefore surgical procedureTime is very long.Lack the function of quickly navigating to clip position.
Patent CN106175986A discloses a kind of valve clamping machine for treating heart valve regurgitation, first folderObject therein can be clamped by mutually drawing close and squeezing the interaction force of generation by closing arm and the second clamping arm.It canSee, be only difficult to capture leaflet by mutually drawing close, extruding then can cause to damage to leaflet.Equally, lack quickly positioning simultaneouslyThe function of leaflet is captured, and is easy to damage leaflet.
Patent CN106606381A discloses a kind of artificial heart valve positioning device, after the valve release to a certain degree,Locating rack is withdrawn, is further continued for completing the release of valve.The problem of design, is that locating rack can not be received again after valve dischargesIt returns, otherwise locating rack can be interfered with the valve after release, influence the subsequent release of valve.Locating rack cannot be guaranteed entirely dischargingAll in positioning states during valve, if the position of valve changes after recycling locating rack, it is fixed to still suffer from implantation materialThe incorrect problem in position.
Therefore, those skilled in the art is dedicated to developing a kind of transportation system with positioning function, on the one hand canIt is whole during discharging implantation material to be accurately positioned；On the other hand the instrumentation time can be reduced, so that the use of contrast agentAmount and amount of radiation reduce, and avoid the collateral damage to patient.
Summary of the invention
The purpose of the present invention is overcome the deficiencies in the prior art, for mitral valve insufficiency and need the trouble of interventional therapyPerson provides a kind of prosthesis delivery system with positioning function.The present invention solves existing implantation instrument and discharges process in implantation materialMiddle no positioning function, or use and radiate cruelly without damaging tissue in full process positioning function, position fixing process, large dosage of contrast agentThe problems such as dew overlong time brings collateral damage.
The purpose of the present invention is what is realized by following scheme:
A kind of prosthesis delivery system with positioning function, including artificial prosthesis, sheath, fixing pipe, positioning device and solidDetermine part, the fixing pipe is arranged in the sheath, the positioning device have preset shape and with the fixing pipeDistal end connects, and the positioning device is detachably connected by the fixing piece and the artificial prosthesis, and the positioning device hasTwo kinds of forms, the first form are that the positioning device is loaded in the distal portions for being limited in the sheath, and the second form is instituteStating positioning device, stretching reverts to the preset shape from the distal end of the sheath, is provided with Support in the positioning deviceDomain and anchor region are not provided with skeleton structure in the anchor region.
The purpose of the present invention can also further realize by the following technical programs:
In one embodiment, the prosthesis delivery system further includes anchor unit, and there are two types of the anchor unit toolsForm, the first form are that the anchor unit is limited in the sheath, and the second form is the distal portion of the anchor unitDivide the state discharged completely from the sheath, when the anchor unit is in the second form, the outlet of the anchor unitSubpoint is located in the anchor region.
In one preferred embodiment, position limiting structure is provided between the anchor unit and the fixing pipe.MorePreferably, the position limiting structure is guide rail structure.
In one embodiment, the supporting zone of the positioning device is provided with skeleton structure, the skeleton structureIncluding two main supporting elements and at least one auxiliary supports, the main supporting element is arranged on the supporting zone and the anchorDetermine the intersection in region.It is furthermore preferred that the angle between two main supporting elements is 45 ° to 180 °, the auxiliary supportsFor 1-7 root.
In one preferred embodiment, the shape of the main supporting element is Cyclotron, arc or Y shape etc..
In one preferred embodiment, when the positioning device is in second form, the skeleton is along diameterTo radially distributing.It is furthermore preferred that the skeleton is integrally machined by memory alloy material.
In one preferred embodiment, the anchor region is fan-shaped, round or ellipse etc..
In one preferred embodiment, buffer structure is provided on the main supporting element and the auxiliary supports.
In a preferred embodiment, the buffer structure be S-shaped, wavy, oval, zigzag, orThe buffer structure is to wrap up flexible material on the free-end of the main supporting element and the auxiliary supports.It is furthermore preferred thatThe flexible material is bovine pericardium/Pigs Hearts packet.
In one preferred embodiment, overlay film is provided between the main supporting element and the auxiliary supports.MorePreferably, the material of the overlay film is polytetrafluoroethylene (PTFE) or terylene.
Preferably, the fixing piece extends radially to the skeleton distal end.
In one embodiment, the fixing piece is wire.In one preferred embodiment, the wire is by straightDiameter is that the nitinol alloy wire of 0.2mm-0.5mm is made.
In one embodiment, the artificial prosthesis is that can be used for mitral valve repair or the valve of tricuspid valve reparation is repairedMultiple instrument.
In one preferred embodiment, the artificial prosthesis is detachable by the fixing piece and the main supporting elementConnection.
In a preferred embodiment, it is provided with connector on the artificial prosthesis, is set on the main supporting elementIt is equipped with cavernous structure, the connector is pierced by from the cavernous structure, and the fixing piece passes through the connector.
In one embodiment, skeleton structure is provided in the positioning device, the skeleton structure includes main branchSupport member and auxiliary supports are additionally provided with retaining structure in the bottom of the positioning device.In one preferred embodiment,The retaining structure is chuck or bar.
In one embodiment, the distal end of the positioning device and the fixing pipe is fixed using welding, bonding wayThe distal end of connection or the positioning device and the fixing pipe is detachably connected.
In one embodiment, the anchor unit includes anchoring channel, anchor log and release member.The anchoring channelCross section be circle, ellipse etc..The anchor log is anchor screws, anchoring needle etc..The release member can be in anchoring channelIt inside moves freely, for discharging anchor log.
Compared with the existing technology, the present invention has the advantages that
1. positioning in real time during artificial prosthesis release may be implemented in positioning device of the present invention.The positioning device is simultaneouslyThe release and anchoring for not interfering artificial prosthesis therefore, there is no need to recycle positioning device before discharging artificial prosthesis, avoid existingPositioning device is first recycled after the completion of skill Intraoperative position, then discharges artificial prosthesis again, and the artificial prosthesis release position that may causeSet the problem of changing.
2. prosthesis delivery system of the present invention with positioning function further includes anchor unit, there are two types of the anchor unit toolsForm, the first form are that the anchor unit is limited in the sheath, and the second form is the anchor unit from the sheathThe state discharged completely is managed, when the anchor unit is in the second form, the subpoint of the outlet of the anchor unit is located atIn the anchor region, can guarantee anchor station it is accurate with it is adjustable.
3. the positioning device in the present invention, without passing through clamping or crawl heart tissue, only by reclining tissue i.e.It can position, avoid the injury to tissue.
4. only positioning function, operating process letter can be realized by the heart tissue that reclines in prosthesis delivery system of the present inventionIt is single, shorten positioning time.
Detailed description of the invention
Fig. 1 is the distal portions structural schematic diagram of prosthesis delivery system of the invention.
Fig. 2 is the structural schematic diagram of an embodiment of the positioning device of prosthesis delivery system of the invention.
Fig. 3 is the structural schematic diagram of the another embodiment of the positioning device of prosthesis delivery system of the invention.
Fig. 4 is the structural schematic diagram of the another embodiment of the positioning device of prosthesis delivery system of the invention.
Fig. 5 is the schematic diagram of the position limiting structure of prosthesis delivery system of the invention.
Fig. 6 a- Fig. 6 b is that the artificial prosthesis of prosthesis delivery system of the invention and positioning device are detachably connected signalFigure.
The structural representation of the another embodiment of the positioning device of Fig. 7 c prosthesis delivery systems of the invention of a- Fig. 7Figure.
Fig. 8 a- Fig. 8 e is the operating procedure schematic diagram of the prosthesis delivery system of the invention.
Specific embodiment:
To make the objectives, technical solutions, and advantages of the present invention more comprehensible, right hereinafter, referring to the drawings and the embodiments,The present invention is further described.
Distal end of the present invention refers to one end far from operator, one end of the proximal end refers to Proximity operation person.
In one embodiment, as shown in Figure 1, a kind of prosthesis delivery system 100 with positioning function, including it is artificialProsthese 110, the fixing pipe 130 being arranged in the sheath 120, is determined with what the distal end of the fixing pipe 130 was connect at sheath 120Position device 140 and fixing piece 150, the positioning device 140 have preset shape, and the positioning device 140 passes through described solidDetermine part 150 to be detachably connected with the artificial prosthesis 110, there are two types of forms for the tool of positioning device 140, and the first form is describedPositioning device 140 is loaded the compressive state being limited in the distal portions of the sheath 120, and the second form is positioning dressIt sets 140 and is stretched out from the distal end of the sheath 120 and revert to the release conditions of the preset shape, in the positioning device 140It is provided with supporting zone 142 and anchor region 141, is not provided with skeleton structure in the anchor region 141.The artificial prosthesis130 be the valve reparation instrument that can be used for mitral valve repair or tricuspid valve reparation.The positioning device 140 and the fixing pipe130 distal end is fixedly connected using welding, bonding way or the distal end of the positioning device 140 and the fixing pipe 130 canDismantling connection.The transportation system further includes having anchor unit 160, wire leading pipe 190 and fixing with the distal end of the wire leading pipe 190The TIP head 180 of connection, in one embodiment, the anchor unit 160 and the wire leading pipe 190 are arranged on the sheathIn pipe 120.The subpoint of the outlet of the anchor unit 160 is located in the anchor region 141.The anchor unit 160 hasThere are two types of form, the first form is that the anchor unit 160 is limited in the sheath 120, and the second form is the anchoringThe state that the distal portions of unit 160 discharge completely from the sheath 120, when the anchor unit 160 is in the second form,The subpoint of the outlet of the anchor unit 160 is located in the anchor region 141.The throwing of the outlet of the anchor unit 160Shadow point, which refers to, is formed by orthographic projection being parallel to patient's annulus plane.The distal portions of the anchor unit are by shape memory materialMaterial is made, and has preset shape, and in one embodiment, the preset shape is in 180 ° of hook solids.Work as anchor unitWhen 160 distal portions discharge completely from the sheath 120, the distal portions of the anchor unit restore preset shape, makeThe forward projection point that is formed in the plane of patient's annulus of remote outlet of anchor unit 160 is located in anchor region 141, i.e. anchorThe remote outlet of order member 160 is directed at anchor region 141, and structure design can guarantee the accurate of anchor station.At anotherIn embodiment, the anchor unit includes anchoring channel, anchor log and release member.The cross section in the anchoring channel is circleShape, ellipse etc..Anchor log and release member are placed in the anchoring channel, the distal end of the release member and the anchor logProximal end offset, the anchor log is anchor screws, anchoring needle etc..The release member can move freely in anchoring channel, useIn release anchor log.The distal portions of the anchor unit 160 are additionally provided in the anchor unit 160 by that can be bentSilk is adjusted, the distal end for adjusting silk is fixedly connected with the distal end of the anchor unit 160, and the proximal end for adjusting silk is extendedIn vitro, operator adjusts the bending angle of the adjustable anchor unit distal end of silk, the outlet of the anchor unit 160 by operationSubpoint be located in the anchor region 141.
In one embodiment, as shown in Fig. 2, the supporting zone 142 of the positioning device 140 is provided with skeleton knotStructure, the skeleton structure include two main supporting elements 1421 and an auxiliary supports 1422, and the main supporting element 1421 is setSet the intersection in the supporting zone 142 and the anchor region 141.The anchor region 141 is sector.Two mastersAngle between supporting element 1421 is 45 ° to 180 °.The main support rod 1421 is straight-bar.In one embodiment, describedMain support rod is the (not shown) such as Cyclotron or Y shape.In one embodiment, as shown in figure 3, the skeleton structure is by rememberingAlloy is integrally machined, and the skeleton structure includes two main supporting elements 1421 and seven auxiliary supports 1422.When describedWhen positioning device 140 is in the second form, the skeleton structure radially radially distributes.Two main supporting elements 1421Between angle be 88 °.Region between two main supporting elements 1421 constitutes the anchor region 141, the anchoringRegion 141 is fan-shaped.Cavernous structure 1423 is provided on two main supporting elements 1421, the cavernous structure 1423 is ellipseHole.Overlay film 1425 is provided between the main supporting element 1421 and the auxiliary supports 1422, the overlay film 1425 is poly- fourFluoride material, the overlay film 1425 are formed in the skeleton structure by high-temperature high-pressure.It is set on the auxiliary supports 1422It is equipped with buffer structure 1424, the buffer structure 1424 is serrated.In another embodiment, the buffer structure 1424For S-shaped, wavy, oval, zigzag.
In another embodiment, described as shown in figure 4, the skeleton structure is integrally machined by memorial alloySkeleton structure includes two main supporting elements 1421 and three auxiliary supports 1422.Two main support rods 1421 are arc, work as instituteWhen stating positioning device 140 and being in the second form, the radially extending release of two main supporting elements 1421.Two main supportsCircular anchor region 141 is defined between part 1421.In one embodiment, it is enclosed between described two main supporting elements 1421At the anchor region 141 of ellipse.Cavernous structure 1423 is provided on the end of described two main supporting elements 1421, it is describedCavernous structure 1423 is circular hole.Overlay film 1425, institute are provided between the main supporting element 1421 and the auxiliary supports 1422Stating overlay film 1414 is polyester material, and the polyester material is connect by suture with the skeleton structure.The auxiliary supportsBuffer structure 1424 is provided on 1422, the buffer structure 1424 is to wrap up on the free-end of the auxiliary supports 1422Flexible material.The flexible material is bovine pericardium or Pigs Hearts packet.
In one embodiment, as shown in Figure 5.The positioning device 140 and the fixation with anchor region 141Pipe 130 is connected using modes such as welding, is provided with position limiting structure 170 between the anchor unit 160 and the fixing pipe 130,The position limiting structure 170 is guide rail structure, limits the rotation of the anchor unit 160, makes anchor unit 160 only can be along described solidDetermine the axial movement of pipe 130.The purpose of the position limiting structure 170 is to guarantee the projection point of the outlet of the anchor unit 160In the relative position in anchor region 141, that is, limiting the anchor region 141 with the outlet subpoint of the anchor unit 160.Because the plane where the axis of the anchor unit 160 is perpendicular to the plane where anchor region 141, so in developmentIt can assist determining 141 position of anchor region, realize that fast accurate is positioned and is anchored, solve to position dress in existing issueSetting whole can not position in real time, and positioning device and implantation material are the problems such as release completion front position can not be fixed relatively.It is described solidDetermining part 150 is wire, and the fixing piece 150 is that 0.2mm-0.5mm nitinol alloy wire is made by diameter.The fixing piece150 one end is detachably connected with the positioning device 140, and the other end of the fixing piece 150 extends in vitro, or with it is defeatedThe handle of system is sent to be fixedly connected.The fixing piece 150 extends radially to the skeleton after passing through 130 distal end of fixing pipe141 distal ends.
In another embodiment, as shown in Figure 6 a.The skeleton structure includes main supporting element 1421 and Auxiliary supportPart 1422.1421 distal end of main supporting element is designed with round and smooth structure, to prevent in position fixing process to patient's heart tissueCause unnecessary injury.1422 distal end of auxiliary supports has structure design that is round and smooth and upwarping, so that the auxiliary1422 distal exterior of supporting element does not damage when contacting with heart tissue.The artificial prosthesis 110 passes through fixing piece 150 and instituteMain supporting element 1421 is stated to be detachably connected.Described be detachably connected can be accomplished by the following way: on the artificial prosthesis 110It is provided with connector 111, cavernous structure 1423 is set on the main supporting element 1421, the connector 111 is from described poroidBe pierced by structure 1423, the fixing piece 150 passes through the connector 111 so that the artificial prosthesis 110 be fixed on it is describedIn positioning device 140.After the completion of the artificial prosthesis 110 discharges and is anchored, the proximal end of the fixing piece 150 is pulledRealize the separation of artificial prosthesis 110 and positioning device 140.In one preferred embodiment, the connector 111 is annulus112 or the connector be n shape structure.
In another embodiment, as shown in Figure 6 b.The artificial prosthesis 110 is flexible barcode object, the artificial vacationAnnulus 112 is provided on body 110.The artificial prosthesis 110 is detachably connected by fixing piece 150 with the main supporting element 1421It connects.Described be detachably connected can be accomplished by the following way: cavernous structure 1423 is set on the main supporting element 1421, it is describedAnnulus 112 is pierced by from the cavernous structure 1423, and the fixing piece 150 passes through the annulus 112, so that the artificial prosthesis110 are fixed in the positioning device 140.After the completion of the artificial prosthesis 110 discharges and is anchored, the fixation is pulledThe separation of artificial prosthesis 110 and positioning device 140 can be realized in the proximal end of part 150.
In another embodiment, as shown in Figure 7a.It is provided with skeleton structure in the positioning device 140, it is describedSkeleton structure includes main supporting element 1421 and auxiliary supports 1422.Detent is additionally provided in the bottom of the positioning device 140Structure.In one preferred embodiment, the retaining structure is chuck 1401.The chuck 1401 is compiled by memory alloy wireIt makes, the memory alloy wire can be nitinol alloy wire, and the nitinol alloy wire diameter is 0.25mm-0.4mm.The chuck1401 are fastenedly connected by tantalum ring 1402 with the main supporting element 1421 and auxiliary supports 1422.In a preferred embodiment partyIn formula, as shown in Figure 7b.The retaining structure is bar, and the bar is L shape bar 1403.Because the L shape bar 1403 is with described inSkeleton structure is cut by same Nitinol pipe, therefore one end of the L shape bar 1403 and the natural phase of the skeleton structureEven, the L shape bar 1403 is after heat treatment formed.The other end of the L shape bar 1403 passes through tantalum ring 1402 and the masterSupporting element 1421 or auxiliary supports 1422 are fastenedly connected.In another preferred embodiment, as shown in Figure 7 c, the cardBit architecture is bar, and the bar is L shape double rod 1404.Because the L shape double rod 1404 and the skeleton structure are by same NiTiCompo pipe is cut, therefore one end of the L shape double rod 1404 is naturally connected with the skeleton structure, is after heat treatment formedThe L shape double rod 1404.The other end of the L shape double rod 1404 is free end.Between the L shape double rod 1404 forBy region 1405, in one preferred embodiment, Auxiliary support bracket is provided in the abutting region 1405.It is describedAbutting region 1405 is also covered with film, and the film is made of terylene or polytetrafluoroethylene (PTFE).Preferably, the film coats the auxiliarySupporting support.Retaining structure, which is arranged, can preferably position the position of anchor point, and provide position feedback for doctor's operation.
Fig. 8 a- Fig. 8 e shows the step of prosthesis delivery system 100 discharges artificial prosthesis 110.Prosthese conveyingSystem 100 reaches bicuspid valve atrium side position through apex of the heart approach, and the distal end position of the prosthesis delivery system 100 is determined by radiographyAbove annulus of mitral valve.The mobile sheath 120 discharges the positioning device 140, and the positioning device 140 is rested against two pointsIn annulus, the prosthesis delivery system 100 is observed and rotated to radiography, 140 position of positioning device is adjusted, so that the anchoringRegion 141 is located at after the mitral valve annulus middle, and the positioning of artificial prosthesis 110 is completed at this time.Pull down the anchor unit160, by the outlet of the anchor unit 160 against the anchor region 141, it is anchored.It is withdrawn after the completion of anchoring described solidDetermine part 150, the positioning device 140 is separated with the artificial prosthesis 110.Mobile sheath 120 receives sheath, finally by the prostheseTransportation system 100 withdraws from the implantation for completing the artificial prosthesis 110 in vitro.From operating procedure above it is found that institute of the inventionStating prosthesis delivery system only can be realized positioning function by the heart tissue that reclines, and operating process is simple, shorten positioning time,Reduce operation risk.
Finally it should be noted that the foregoing is merely preferred embodiments of the invention, not to limit thisInvention, any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in this hairWithin bright protection scope.