CN103330605B - A kind of sheath core and comprise the intervention apparatus conveying system of this sheath core - Google Patents

A kind of sheath core and comprise the intervention apparatus conveying system of this sheath core Download PDF

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Publication number
CN103330605B
CN103330605B CN201310085665.2A CN201310085665A CN103330605B CN 103330605 B CN103330605 B CN 103330605B CN 201310085665 A CN201310085665 A CN 201310085665A CN 103330605 B CN103330605 B CN 103330605B
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core
sheath
bending rigidity
pipe
sheath core
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CN103330605A (en
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王约翰
张志飞
张启明
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Hangzhou Qiming Medical Devices Co., Ltd.
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HANGZHOU QIMING MEDICAL DEVICE CO Ltd
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Abstract

The invention discloses a kind of sheath core and comprise the intervention apparatus conveying system of this sheath core, one end of described core pipe is the far-end for connecting intervention apparatus, and the other end is near-end; Described core pipe has bending rigidity and reduces section at adjacent distal end place.Intervention apparatus conveying system of the present invention, comprises sheath pipe and is positioned at the described sheath core of sheath pipe.Sheath core of the present invention, compliance is good, in valve replacement surgery, is more prone to turn, has evaded operation risk, be particularly useful for cusps of pulmonary valve replacement.

Description

A kind of sheath core and comprise the intervention apparatus conveying system of this sheath core
Technical field
The present invention relates to technical field of medical instruments, particularly relate to a kind of sheath core and comprise this sheath core intervention apparatus conveying system.
Background technology
When the cardiac valve (Bicuspid valve, Tricuspid valve, aortic valve or valve of pulmonary trunk) of patient self causes variation due to congenital or acquired disease, cause valve can not normally opening and closing time, can impact healthy living and even life.Valvular variation can be divided into open incomplete and incompetence, and both of these case can cause cardiac load to increase, and whether heart can also normally work under this load is the Main Basis whether decider's systemic heart valve should replace.
When client need changes valve, existing method adopts open surgical operation to change lobe, and doctor will open breast by cardiac arrest for patient, is attempted by external cardiopulmonary circulatory system.Then open heart of patient the cardiac valve of pathological changes is excised, then Cardiac valve prosthesis seam is put and gone up in position, finally heart and thoracic cavity are sewed up.This is a very large operation process of wound, and have certain mortality risk, patients ' recovery is chronic, and because operation wound is large, health cannot bear a lot of patient, can not perform the operation although need to change lobe.
In view of the shortcomings that open surgery exists, little with its wound by the mode of intervene operation implanted prosthetic heart valve, the advantages such as the invasive of human body is few are received publicity further.This operation is not when operating on, the little opening of diameter several millimeters is done in the skin of patient, the vascular system of sensible human body, sets up transfer passage thus, then by special induction system, Cardiac valve prosthesis and support is delivered to heart and alternative defective native valve.
Usually, induction system is fixed on by support on a bracket fixing head, bracket fixing head is connected to one end of core pipe, this bracket fixing head front end is with fairshaped seeker, the construction section of nested rack is provided with between seeker and bracket fixing head, above-mentioned core pipe, bracket fixing head, construction section and seeker together constitute sheath core, when carrying out valve implantation, first bracket clamp is incorporated on the bracket fixing head of conveyer device, sheath pipe box is in the outside of sheath core, keep the compressive state of support, sheath pipe, sheath core carries support is pushed to pathological changes valve site from the porch of blood vessel, releasing bracket again, support can expand under the effect of body temperature, the blade of human body valve is pressed to blood vessel wall completes in place, and then sheath pipe and sheath core are extracted out.
In valve replacement surgery, induction system carries support need could arrive implantation site through the human vasculature of winding complex, such as, during displacement aortic valve, general elder generation is from femoral artery puncture, through ventral aorta, descending aorta, again through aortic arch, drive in the wrong direction to aortic root and carry out the displacement of valve, induction system is defining large bending through aortic arch, equally, in Bicuspid valve and tricuspid replacement process, induction system is also at least through the crooked position of a vascular, this just require induction system possess enough can promotion to guarantee that support can while tracking advances to native valve position, also enough compliances must be possessed to guarantee the sweep of support tracking by body vessels, prevent the mechanical damage to inside of human body.
In replacement of pulmonary valve, aobvious particularly important of the compliance of induction system.During valve of pulmonary trunk displacement, first from femoral venous puncture, through postcava, right atrium, Tricuspid valve, right ventricle, walk to the displacement that pulmonary artery carries out valve, significantly different from aortic valve, Bicuspid valve and Tricuspid valve, the implantation path of valve of pulmonary trunk is serpentine, in whole implantation process, induction system can through two sweeps, and the degree of crook of these two sweeps is larger than aortal.
Obvious, this is higher to the requirement of the compliance of induction system, but in current replacement of pulmonary valve, still adopt the induction system identical with aortic valve replacement, this just makes, and advances or exits in the process of human body, be more prone to injured blood vessel, cardiac muscle, Tricuspid valve in induction system, even may cause the dislocation of support, operation risk increases.
Although never halt the improvement of the compliance of induction system, but research still concentrates on the structure of sheath pipe or the improvement of material, because sheath pipe need resist the swelling state of support, keep the compressive state of support, and need the propelling movement of retainer shaft reclaiming, in the process of releasing bracket, therefore, sheath pipe itself has very high requirement to its pressure-bearing property and fold resistance, must possess certain axial support intensity, thus the space that sheath pipe compliance is improved is extremely limited, poor effect.
Summary of the invention
The invention provides a kind of sheath core, compliance is good, in valve replacement surgery, is more prone to turn, avoids causing mechanical damage to inside of human body, evaded operation risk, reduced operating difficulty.
A kind of sheath core, comprise core pipe, one end of described core pipe is the far-end for connecting intervention apparatus, and the other end is near-end; Described core pipe has bending rigidity and reduces section at adjacent distal end place.
Namely described core pipe is lower than the remainder of core pipe in the bending rigidity of a section at adjacent distal end place.
Bending rigidity embodies object and resists its diastrophic ability, and bending rigidity is larger, and sheath core is more not easy to bend, otherwise bending rigidity is less, then sheath core easily deforms deformation, compliance better (i.e. easy bending under the effect of radial force has radial flexibility).
Because general intervention apparatus (below all for support) length is shorter, if stent length is at about 60mm, therefore, the part of sheath core mounting bracket is less in the difficulty of human body inside turn, core pipe is then faced with complicated turning process in the part of adjacent distal end, as in replacement of pulmonary valve, this position need turn twice curved, formed serpentine.
Therefore, when the bending rigidity reduction section that the present invention is arranged makes induction system pass through complicated tortuous vascular system, easily bending, it is made to run in the process of turning more smooth and easy, this has just evaded induction system injured blood vessel, cardiac muscle, Tricuspid valve, or the operation risk of support dislocation, simultaneously, other parts (bending rigidity reduces the part beyond section) of the core pipe of sheath core still keep relatively large bending rigidity, this guarantees sheath mandrel to propelling movement (namely axially not easily compress), ensure induction system by stent pushing to implantation site of performing the operation.
It will be understood by those in the art that far-end of the present invention refers in induction system, core pipe is away from one end of operating grip, and described near-end refers in induction system, and core pipe is near one end of operating grip.
Bending rigidity reduces section should as much as possible near the far-end of core pipe, and certainly, also can allow less distance, this distance is not more than 50mm usually.
Above-mentioned distance refers to the distance between the end of one end of bending rigidity reduction section adjacent distal end to core pipe far-end.
In order to the convenience of processing technique, simultaneously also for making the compliance of sheath core better, further preferably, described bending rigidity reduces section and intervention apparatus is close to, and namely the far-end of described core pipe is one end that bending rigidity reduces section.
It can be homogeneous (namely identical) that described bending rigidity reduces section bending rigidity everywhere, also can be different, namely present certain change, and this change both can be random change, and also can present certain regularity.
Alternatively, described bending rigidity reduction section reduces gradually along direction bending rigidity distally.
Bending rigidity reduces section and reduces gradually along direction bending rigidity distally, and mean that sheath core is the closer to far-end, compliance is better, and reduce gradually both can be continuous print herein, also can be that segmentation reduces.
The low bending rigidity that described bending rigidity reduces section realizes by multiple means such as Material selec-tion, structure changes.
Usually, the core pipe of sheath core is the spring tube structure of braided steel wire, and this structure ensure that propelling movement and the compliance of sheath core.Obvious, in the present invention, described bending rigidity reduces the bourdon tube that section also can be made for steel wire, by changing weaving manner as steel wire strand is become single steel wire, or changes the bending rigidity that the means such as gauge of wire reduce this section.
It should be noted that core pipe comprises bending rigidity and reduces the processing of section and be not limited in weaving, also can adopt laser engraving technique or other manufacturing process.
In addition, the material by selecting bending rigidity more weak also can reach the object reducing bending rigidity.
Be no matter the conversion of structure or material, the propelling movement that sheath core all should be kept basic and safety, the especially selection of material, should meet the relevant criterion requirement of medical apparatus and instruments.
The bending rigidity ratio that described bending rigidity reduces other parts of Duan Yuxin pipe is 1:2 ~ 1:6, is preferably 1:2 ~ 1:4, is more preferably 1:4.
Bending rigidity calculates can adopt conventional method, also can adopt simple and easy method.
Ratio is too small, then bending rigidity reduces the bending rigidity of section greatly, and the flexibility of sheath core is inadequate;
Ratio is excessive, then the bending rigidity of bending rigidity reduction section is little, and sheath core is too soft, pushes power inadequate.
The length that described bending rigidity reduces section is generally 120 ~ 180mm, and preferably, the length that described bending rigidity reduces section is 140 ~ 160mm, is more preferably 150mm.
The length that bending rigidity reduces section is long, and the propelling movement power of sheath core is inadequate, and length is too short, then affect the compliance of sheath core.
Obvious, bending rigidity reduces the length of section can the adaptive setting according to concrete operation pathway, example is replaced into valve of pulmonary trunk, owing to implanting path in " S " type, the distance of two bends that need be able to turn over according to induction system is arranged, and makes two bending bending rigidities that occur in reduce section.
Bending rigidity is reduced section and can be connected by connector with other parts of described core pipe, also can be one-body molded.
Although bending rigidity reduces other parts difference to some extent that section resists diastrophic ability and core pipe, as preferred, the external diameter that described bending rigidity reduces other parts of Duan Yuxin pipe is identical.Can ensure that the external diameter of whole core pipe is consistent, This prevents between sheath pipe and core pipe and produce gap, avoid bending in sheath pipe running.
The far-end of described core pipe is connected with bracket fixing head, and this bracket fixing head is connected with seeker by the construction section for nested rack.
Preferably, the periphery of described core pipe is covered with the drag reduction layer of tetrafluoroethene material.
Sheath core in use outside also cover have sheath pipe, apparent, drag reduction layer of the present invention is the structure sheaf reducing sliding-frictional resistance between sheath core and sheath pipe.
The core pipe of sheath core arranges drag reduction layer, and can reduce the resistance during motion of sheath core, namely make the frictional force between sheath core and sheath pipe diminish, both relative motioies are more smooth and easy, the release force of support is diminished, is also easy to the recovery of support, reorientates.
Meanwhile, drag reduction layer is the Rotating fields of continuous distribution, is wrapped up the periphery of core pipe, has so just played the effect of sealing, and during water filling aerofluxus, aerofluxus is more thorough, and avoids Lou blood to form thrombosis.
Drag reduction layer can cover the periphery of core pipe local, and preferably, drag reduction layer covers the periphery of whole core pipe.
Tetrafluoroethene, has self lubricity, and coefficient of friction is low, possesses wear-resisting, resistance to chemical attack simultaneously, sealing well, is not hydrolyzed, the premium properties such as not hardening, and safety is high.
For ease of processing, as preferably, described drag reduction layer is tetrafluoroethene pipe.The tetrafluoroethene pipe of machine-shaping is utilized conveniently to be sleeved on the outside of described core pipe.
The thickness of described drag reduction layer is 0.01 ~ 0.2mm.
Drag reduction layer is blocked up, can affect sheath core diameter to flexibility, in valve replacement process, be unfavorable for that induction system is turned, easily cause injuries such as human vas wall, cardiac muscle, valves, even can cause the dislocation of support;
Drag reduction layer is excessively thin, then can affect sealing effectiveness, causes aerofluxus thorough, and in the use procedure of sheath core, inevitably causes the wearing and tearing on drag reduction layer surface, thus causes gas leakage, leakage blood.
Present invention also offers a kind of intervention apparatus conveying system, comprise sheath pipe and be positioned at the described sheath core of sheath pipe.
For avoiding sheath pipe to bend, the thickness of the drag reduction layer of the core pipe covering of sheath core adapts with the gap between core pipe and sheath pipe.
Sheath core of the present invention, compliance is good, evade operation risk, reduce operating difficulty, be particularly useful for replacement of pulmonary valve, but obvious, sheath core of the present invention and induction system are not limited in the displacement of valve of pulmonary trunk, also can be used for other valves as aortic valve, Bicuspid valve, tricuspid displacement, or this structure is applied to other interventional operation equipment, meet the operation pathway demand of winding complex.
Accompanying drawing explanation
Fig. 1 is the structural representation of sheath core of the present invention;
Fig. 2 is the structural representation of the bending strength reduction section of Fig. 1 core pipe;
Fig. 3 is the sectional view of Fig. 2 along A-A direction;
Fig. 4 is the internal structure schematic diagram after induction system loading dock of the present invention;
Fig. 5 is the internal structure schematic diagram before induction system loading dock of the present invention;
Fig. 6 is the internal structure schematic diagram of induction system of the present invention when holder part stretches out sheath pipe;
Fig. 7 is the internal structure schematic diagram after induction system loading dock of the present invention;
Fig. 8 is the internal structure schematic diagram before induction system loading dock of the present invention;
Fig. 9 is the internal structure schematic diagram of induction system of the present invention when holder part stretches out sheath pipe;
Figure 10 is the profile at induction system mesotheca pipe end position of the present invention.
Wherein,
200-sheath pipe; 300-support; 102-seeker;
103-core pipe; 104-construction section; 105-bracket fixing head;
106-drag reduction layer; 107-locating slot; 108-bending strength reduces section;
222-spiral metal wire; 223-fortifying fibre.
Detailed description of the invention
The present invention is explained further below in conjunction with accompanying drawing.
Fig. 1 shows a kind of sheath core of the present invention, comprise core pipe 103, one end of core pipe 103 is the far-end for connecting intervention apparatus (below for support), the other end is near-end, the far-end of core pipe 103 is connected with bracket fixing head 105, and this bracket fixing head 105 is connected with seeker 102 by the construction section 104 for nested rack.
Bracket fixing head 105 is with through hole, and be the tubular structure be made up of the bigger head of diameter and the smaller afterbody of diameter, the outer wall of bracket fixing head 105 one end is also with the locating slot 107 matched with support.
Core pipe 103 is the hollow pipe with through hole, and seal wire (not shown) is passed from this through hole, and during operation, the track that induction system can be set up along seal wire, enters Operation site.Core pipe 103 has near-end and far-end, and herein, near-end refers to the one end near operating grip, and far-end refers to the one end away from operating grip (not showing in accompanying drawing).
Be construction section 104 between bracket fixing head 105 and seeker 102, construction section 104 is also the hollow pipe with through hole, and construction section 104 is communicated with by inner through hole with core pipe 103.
Seeker 102 is the pyramidal structure of dome, and the dome of seeker 102 has streamlined contour, can avoid scratching blood vessel, and be also conducive to guiding whole conveyer device to advance along blood vessel, the afterbody of seeker 102 is planar structure, for pushing against support.
As shown in Figure 1, the part of core pipe 103 adjacent distal end is that bending rigidity reduces section 108, and this bending rigidity reduces section 108 and is close to bracket fixing head 105, and length is 150mm, and certainly, length can be arranged according to concrete operation pathway.
It is identical in the bending rigidity of each point that bending rigidity reduces section 108, is 1:4 with the bending rigidity ratio of other parts of core pipe 103 (part except bending rigidity reduces section 108).Bending rigidity reduces section 108 and welds together with other parts of core pipe 103, obviously also can adopt other connected mode, but should ensure that core pipe 103 external diameter is everywhere identical.
Conveniently evaluate bending rigidity ratio in the present invention, provide following method of testing: according to endocardial construction features, get sufficiently long one end core pipe, be bent to R=25mm semicircle, the elastic thrust that the one end measuring semicircle produces.
According to bending stiffness formula k = M θ = F * d 2 π 2 = F * d π
Wherein, K is bending rigidity;
M is the moment applied;
θ is the anglec of rotation;
The elastic thrust that one end that F is semicircle produces;
D is half diameter of a circle, i.e. 50mm.
Drawn by above-mentioned formula: the elastic thrust that one end of bending rigidity and semicircle produces has linear ratio relation, therefore the elastic thrust value of bending rigidity reduction section is bending rigidity ratio with the ratio of the elastic thrust value of other parts of core pipe.
See Fig. 2, the bending rigidity of core pipe 103 reduces section 108 helically tubular structure, be made up of single steel wire, this structure not only makes sheath core possess enough propelling movement power, support is pushed valve implantation site, simultaneously sheath core diameter to compliance better, make induction system smoothly by the vascular system of meander, other parts of core pipe 103 also adopt helical tubular structure, are just made up (or adopting single steel wire but gauge of wire overstriking) of steel wire strand, so just ensure that the change of bending rigidity.
Core pipe 103(bending rigidity reduces section and is considered as the part of core pipe) periphery be coated with drag reduction layer 106, this drag reduction layer 106 is the preparation of tetrafluoroethene material, the frictional force between core pipe 103 and sheath pipe can be made to diminish, move more smooth and easy, be convenient to release and the location of support, the thickness of drag reduction layer adapts with the gap between core pipe 103 and sheath pipe usually, bends to avoid sheath pipe.
As shown in Fig. 2 ~ Fig. 3, drag reduction layer 106 is fitted completely with the outer peripheral face of core pipe 103, and the thickness of drag reduction layer is generally 0.01 ~ 0.2mm, and the thickness of drag reduction layer refers generally to the difference (H) of drag reduction layer peak and core tube outer surface peak.
Drag reduction layer 106 is prepared by tetrafluoroethene usually, and in order to the facility of processing, drag reduction layer 106 can be tetrafluoroethene pipe.
Fig. 4 ~ 6 show the induction system for valve replacement surgery provided by the invention, comprise sheath pipe 200 and the sheath core being positioned at sheath pipe 200.In this induction system, sheath core is the above-mentioned structure mentioned, sheath pipe 200 requires to keep necessary hot strength, also to avoid keeping the unobstructed of inside when it is bending, therefore, see Figure 10, spiral metal wire 222 is distributed with around sheath pipe 200 axis in sheath pipe 200, when sheath pipe 200 bends, spiral metal wire 222 can support its housing, keeps the unobstructed of inside.Also be distributed with netted fortifying fibre 223 in sheath pipe 200, it can be made like this to keep higher hot strength, avoid unnecessary distortion.
Fig. 4 shows the state of support installing in induction system, and support 300 is compressed by sheath pipe 200, and in Fig. 6, visible sheath pipe 200 can slide axially relative to other parts, away from seeker 102 when sliding backward, support 300 is exposed release gradually.
During use, first be loaded in induction system by support 300, first make bracket fixing head 105 stretch out sheath pipe 200, seeker 102 is through after support 300, support 300 is fixed in the locating slot 107 of bracket fixing head 105 outer wall, then sheath pipe 200 is wrapped support 300 completely.
After support 300 has loaded, by induction system together with support 300 along the guidewire track established, be delivered to valve implantation site.After induction system arrives implantation site, sheath pipe 200 is drawn back certain distance, support 300 part is made to be exposed in human body environment, position, after having located, continue releasing bracket 300, support 300 meeting spreading under body temperature effect of release, be fixed on implantation site, substitute native valve functionating.In the relative sliding process of sheath core and sheath pipe, drag reduction layer plays buffering, reduces the effect of sliding friction, the release of support is more prone to.
Example is replaced into valve of pulmonary trunk, support need after entering right atrium by femoral vein to turn once curved after enter right ventricle through Tricuspid valve again, then need to turn again and just can enter valve of pulmonary trunk place successively, twice turning makes bending rigidity reduction section place in "S" shape, relative to other parts of core pipe, there is better compliance because bending rigidity reduces section, therefore be more convenient in place in support delivery phase, when support discharges, sheath pipe can withdraw by relative sheath core smoothly, avoids scratching even even at the cost of one's life.

Claims (9)

1. a sheath core, comprises core pipe (103), and one end of described core pipe (103) is the far-end for connecting intervention apparatus, and the other end is near-end; It is characterized in that, described core pipe (103) has bending rigidity and reduces section (108) at adjacent distal end place, described bending rigidity reduces section (108) helically tubular structure, and it is identical with the external diameter of other parts of core pipe that described bending rigidity reduces section (108).
2. sheath core as claimed in claim 1, is characterized in that, described bending rigidity reduces section (108) and reduces gradually along direction bending rigidity distally.
3. sheath core as claimed in claim 1, is characterized in that, the bending rigidity that described bending rigidity reduces section (108) each point is identical.
4. sheath core as claimed in claim 3, is characterized in that, it is 1:2 ~ 1:6 that described bending rigidity reduces section (108) with the bending rigidity ratio of other parts of core pipe (103).
5. sheath core as claimed in claim 1, is characterized in that, the length that described bending rigidity reduces section (108) is 120 ~ 180mm.
6. the sheath core as described in any one of Claims 1 to 5, it is characterized in that, the far-end of described core pipe (103) is connected with bracket fixing head (105), and this bracket fixing head (105) is connected with seeker (102) by the construction section (104) for nested rack.
7. sheath core as claimed in claim 1, it is characterized in that, the periphery of described core pipe (103) is covered with the drag reduction layer (106) of tetrafluoroethene material.
8. sheath core as claimed in claim 7, it is characterized in that, the thickness of described drag reduction layer (106) is 0.01 ~ 0.2mm.
9. an intervention apparatus conveying system, is characterized in that, comprises sheath pipe (200) and is positioned at the sheath core as described in any one of right 1 ~ 8 of sheath pipe.
CN201310085665.2A 2013-03-15 2013-03-15 A kind of sheath core and comprise the intervention apparatus conveying system of this sheath core Active CN103330605B (en)

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US10561509B2 (en) 2013-03-13 2020-02-18 DePuy Synthes Products, Inc. Braided stent with expansion ring and method of delivery
US10292851B2 (en) 2016-09-30 2019-05-21 DePuy Synthes Products, Inc. Self-expanding device delivery apparatus with dual function bump
AU2019204522A1 (en) 2018-07-30 2020-02-13 DePuy Synthes Products, Inc. Systems and methods of manufacturing and using an expansion ring
US10456280B1 (en) 2018-08-06 2019-10-29 DePuy Synthes Products, Inc. Systems and methods of using a braided implant

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