CN110314016A - A kind of valve delivery device and its transportation system - Google Patents
A kind of valve delivery device and its transportation system Download PDFInfo
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- CN110314016A CN110314016A CN201810295492.XA CN201810295492A CN110314016A CN 110314016 A CN110314016 A CN 110314016A CN 201810295492 A CN201810295492 A CN 201810295492A CN 110314016 A CN110314016 A CN 110314016A
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- 230000008961 swelling Effects 0.000 claims abstract description 193
- 210000003709 heart valve Anatomy 0.000 claims abstract description 68
- 210000003205 muscle Anatomy 0.000 claims description 32
- 229920002521 macromolecule Polymers 0.000 claims description 11
- 239000002184 metal Substances 0.000 claims description 8
- 229910052751 metal Inorganic materials 0.000 claims description 8
- 230000008859 change Effects 0.000 claims description 7
- 230000004323 axial length Effects 0.000 claims description 5
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 claims description 2
- 239000010931 gold Substances 0.000 claims description 2
- 229910052737 gold Inorganic materials 0.000 claims description 2
- 230000001464 adherent effect Effects 0.000 abstract description 12
- 230000001225 therapeutic effect Effects 0.000 abstract description 5
- 238000010586 diagram Methods 0.000 description 10
- 230000003902 lesion Effects 0.000 description 6
- 238000000034 method Methods 0.000 description 4
- 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 4
- 229910001000 nickel titanium Inorganic materials 0.000 description 4
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical compound O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 description 3
- 239000004698 Polyethylene Substances 0.000 description 3
- 208000018578 heart valve disease Diseases 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 230000007246 mechanism Effects 0.000 description 3
- 239000004417 polycarbonate Substances 0.000 description 3
- 238000002601 radiography Methods 0.000 description 3
- 238000001356 surgical procedure Methods 0.000 description 3
- 241000463219 Epitheca Species 0.000 description 2
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- 229920000573 polyethylene Polymers 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 206010020772 Hypertension Diseases 0.000 description 1
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- 240000007594 Oryza sativa Species 0.000 description 1
- 235000007164 Oryza sativa Nutrition 0.000 description 1
- 229930040373 Paraformaldehyde Natural products 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- XECAHXYUAAWDEL-UHFFFAOYSA-N acrylonitrile butadiene styrene Chemical compound C=CC=C.C=CC#N.C=CC1=CC=CC=C1 XECAHXYUAAWDEL-UHFFFAOYSA-N 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
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- 208000029078 coronary artery disease Diseases 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The present invention provides a kind of valve delivery device and its transportation system, the valve delivery device includes: conduit part, the conduit part has for being delivered to the intracorporal distal end of people and for the proximal end for remote operation, and the conduit part includes intermediate sheath, the outer sheath being sheathed on outside the intermediate sheath and the interior sheath being sheathed in the intermediate sheath；Swelling part for being positioned to the heart valve prosthesis, the swelling part is fixed on the distal end of the intermediate sheath, the swelling state and non-expansion state that the swelling part has form different, and the swelling part is connect with the interior sheath；It is set to the first control structure of the proximal end of the conduit part；And it is set to the second control structure of the proximal end of the conduit part.Valve delivery device provided by the invention can be positioned and be limited to heart valve prosthesis, and it is good adherent to can guarantee heart valve prosthesis, and then prevent the generation of perivalvular leakage, reach preferable therapeutic effect.
Description
Technical field
The present invention relates to the field of medical instrument technology more particularly to a kind of valve delivery device and its transportation systems.
Background technique
Valvular heart disease is a kind of common cardiovascular diseases that disease incidence is only second to coronary heart disease and hypertension, morbidity
Rate significantly improves with advancing age, and with the aging of social population, valvular heart disease has become one
Important public health problem.
Currently, being usually to do valve surgery using valve delivery device, to be treated to valvular heart disease patient.
However, during doing valve surgery using existing valve delivery device, due to release process not operation receiveing person's control of valve
System, and the radial support power of valve is insufficient, is easy to cause valve that cannot discharge completely, causes valvular function limited, and then be easy
Perivalvular leakage occurs in lesion locations, influences valve surgery curative effect.
As it can be seen that there is therapeutic effect difference in existing valve delivery device.
Summary of the invention
The embodiment of the present invention provides a kind of valve delivery device and its transportation system, to solve existing valve delivery device
There is a problem of therapeutic effect difference.
The embodiment of the invention provides a kind of valve delivery devices, for heart valve prosthesis to be implanted into human body, the valve
Film conveying device includes:
Conduit part, the conduit part have for being delivered to the intracorporal distal end of people and for the proximal end for remote operation, institute
Conduit part is stated to include intermediate sheath, the outer sheath being sheathed on outside the intermediate sheath and be sheathed on interior in the intermediate sheath
Sheath, the outer sheath and the interior sheath can be slided relative to the intermediate sheath, the heart valve prosthesis setting
It in the far-end, and is clipped between the intermediate sheath and the outer sheath, so that the intermediate sheath and the outer sheath
When opposite sliding, the heart valve prosthesis is released；
Swelling part for being positioned to the heart valve prosthesis, the swelling part are fixed on the intermediate sheath
The distal end of pipe, the swelling part have a different swelling state and non-expansion state of form, and the swelling part with it is described
Interior sheath connection can control the swelling part in the expansion when the interior sheath and the intermediate sheath are slided relatively
Change between state and the non-expansion state；
Be set to the proximal end of the conduit part, for controlling intermediate sheath sliding opposite with the outer sheath the
One control structure；
And be set to the conduit part proximal end, for controlling, the interior sheath and the intermediate sheath are opposite to be slided
The second control structure.
Optionally, first control structure includes:
The control-rod being fixedly connected with the proximal end of the intermediate sheath；
And it is sheathed on the handle jacket outside the control-rod, the handle jacket is fixedly connected with the outer sheath；
Wherein, the handle jacket can be moved relative to the control-rod along the axial direction of the control-rod, to drive
The intermediate sheath is opposite with the outer sheath to be slided.
Optionally, the control-rod is with externally threaded threaded rod；
The handle jacket has the internal screw thread cooperated with the external screw thread, when rotating the handle jacket, the handle
Housing moves axially on the threaded rod.
Optionally, second control structure includes:
It is fixedly connected on the function handle of the proximal end of the control-rod, the function handle is equipped with push button and for switching
The proximal end of three gears of position of the push button on the axial direction of the interior sheath, the interior sheath passes through the control
The inside of bar and the function handle, and be fixedly connected with the push button, so that the push button drives when different stalls change
The relatively described intermediate sheath sliding of the interior sheath.
Optionally, the swelling state includes the first swelling state and the second swelling state, and the swelling part is in institute
There is first external diameter when stating the first swelling state, there is second external diameter in second swelling state, in the unexpansive shape
There is third outer diameter, wherein the first external diameter is greater than the second external diameter, and the second external diameter is greater than outside the third when state
Diameter, and the third outer diameter is less than the internal diameter of the outer sheath, so that swelling part when being in the non-expansion state
It can be placed in the outer sheath.
Optionally, the interior sheath is arranged in the inside of the swelling part, and fixes with the distal end of the swelling part
The distal end of connection, the proximal end of the swelling part and the intermediate sheath is fixedly connected, so that during the interior sheath is relatively described
Between sheath slide when, the distal end that can draw the swelling part is moved relative to the proximal end of the swelling part, makes institute
The axial length for stating swelling part changes, to control the swelling part in first swelling state, described second swollen
Switch between swollen state and the non-expansion state.
Optionally, the swelling part is cylinder-like structure, and the swelling part includes the deformable muscle of N item and connects respectively
Two fixing ends of the opposite end of the deformable muscle of N item are connected to, the deformable muscle of N item is between the circumferential direction of the fixing end
Every setting, the both ends of every deformable muscle are equipped with the first aperture, and the middle part of every deformable muscle is equipped with the second aperture, wherein
The area of first aperture is greater than the area of second aperture, and N is the integer more than or equal to 3 and less than or equal to 20.
Optionally, the width at the width of every of the swelling part deformable muscle end respectively less than middle part, described first
Aperture and second aperture are slotted hole, and the width of first aperture is greater than the width of second aperture.
Optionally, the outer sheath includes metal tube and macromolecule woven tube, and the outer sheath is compiled by the macromolecule
Pipe is knitted to be fixedly connected with the handle jacket, when the outer sheath slides into the distal end of the conduit part, the swelling part quilt
The metal tube clad.
In the embodiment of the present invention, since the valve delivery device includes swollen for being positioned to heart valve prosthesis
Swollen component, and the swelling state and non-expansion state that the swelling part has form different, thus defeated using the valve
When device being sent to convey heart valve prosthesis, the heart valve prosthesis can be positioned and be limited by the swelling part
Position, so that the heart valve prosthesis can be released into accurately diseased region, and can be released in the heart valve prosthesis
Afterwards, radial force is applied to the heart valve prosthesis using the swelling part, enables the heart valve prosthesis good
It is adherent, and then the generation of perivalvular leakage can be effectively prevented, reach preferable therapeutic effect.
Detailed description of the invention
Fig. 1 is the structural schematic diagram of valve delivery device provided in an embodiment of the present invention；
Fig. 2 is the structural schematic diagram of the first control mechanism and the second control mechanism provided in an embodiment of the present invention；
Fig. 3 is the schematic diagram that swelling part provided in an embodiment of the present invention is in non-expansion state；
Fig. 4 is the schematic diagram that swelling part provided in an embodiment of the present invention is in the first swelling state；
Fig. 5 is the schematic diagram that swelling part provided in an embodiment of the present invention is in the second swelling state；
Fig. 6 is the structural schematic diagram of swelling part provided in an embodiment of the present invention；
Fig. 7 is the expanded schematic diagram of swelling part provided in an embodiment of the present invention；
Fig. 8 is the schematic diagram that valve delivery device provided in an embodiment of the present invention reaches target lesion position；
Fig. 9 is that control swelling part provided in an embodiment of the present invention is in signal of first swelling state to be positioned
Figure；
Figure 10 is the schematic diagram that heart valve prosthesis provided in an embodiment of the present invention is released from valve delivery device；
Figure 11 is that swelling part provided in an embodiment of the present invention moves to heart valve prosthesis inner cavity to carry out adherent signal
Figure；
Figure 12 is the schematic diagram that heart valve prosthesis provided in an embodiment of the present invention is separated with valve delivery device.
Specific embodiment
To keep the technical problem to be solved in the present invention, technical solution and advantage clearer, below in conjunction with attached drawing and tool
Body embodiment is described in detail.
As shown in Figure 1, the embodiment of the present invention provides a kind of valve delivery device 100, for heart valve prosthesis to be implanted into
Human body, the valve delivery device 100 include:
Conduit part 101, the conduit part 101 have for being delivered to the intracorporal distal end of people and for for the close of remote operation
End, the conduit part 101 include intermediate sheath 1011, the outer sheath 1012 being sheathed on outside the intermediate sheath 1011 and are arranged
Interior sheath in the intermediate sheath 1011, the outer sheath 1012 and the interior sheath can be relative to the intermediate sheaths
Pipe 1011 slides, and the heart valve prosthesis is set to the far-end, and is clipped in the intermediate sheath 1011 and the epitheca
Between pipe 1012, when so that the intermediate sheath 1011 and the outer sheath 1012 being slided relatively, the heart valve prosthesis quilt
Release；
Swelling part 102 for being positioned to the heart valve prosthesis, the swelling part 102 are fixed on described
The distal end of intermediate sheath 1011, the swelling state and non-expansion state that the swelling part 102 has form different, and it is described swollen
Swollen component 102 is connect with the interior sheath, when the interior sheath and the intermediate sheath 1011 are slided relatively, can be controlled described
Swelling part 102 changes between the swelling state and the non-expansion state；
Be set to the proximal end of the conduit part 101, for controlling the intermediate sheath 1011 and the outer sheath 1012
First control structure 103 of opposite sliding；
And be set to the conduit part 101 proximal end, for controlling the interior sheath and the intermediate sheath 1011
Second control structure 104 of opposite sliding.
In the present embodiment, as shown in Figure 1, the valve delivery device 100 includes conduit part 101, the conduit part 101 has
Have for being delivered to the intracorporal distal end of people and for the proximal end for remote operation, i.e. heart valve prosthesis can be loaded in described lead
The distal end of pipe portion 101, enters the valve diseased region of human body with the distal end of the conduit part 101, and the conduit part 101
Proximal end then can be used for that control mechanism is arranged, for remote operation.
The conduit part 101 include intermediate sheath 1011, the outer sheath 1012 that is sheathed on outside the intermediate sheath 1011 with
And it is sheathed on the interior sheath in the intermediate sheath 1011, and the outer sheath 1012 and the interior sheath can be relative to institutes
It states intermediate sheath 1011 to slide, the heart valve prosthesis can be loaded into the intermediate sheath 1011, and can be clipped in institute
It states between intermediate sheath 1011 and the outer sheath 1012, in this way, when the outer sheath 1012 is relative to the intermediate sheath
1011 to the conduit part 101 proximal slide when, the heart valve prosthesis can expose from the outer sheath 1012, and
The heart valve prosthesis can be separated by self-expanding with the valve delivery device 100, release to human body valve lesion
Position.
The valve delivery device 100 further includes swelling part 102, and the swelling part 102 is fixed on the intermediate sheath
The distal end of pipe 1011, and the swelling state and non-expansion state that the swelling part 102 has form different, the swelling part
102 connect with the interior sheath, when the interior sheath and the intermediate sheath 1011 are slided relatively, can control the bulge
Part 102 changes between the swelling state and the non-expansion state, and the heart valve prosthesis is loaded into the bulge
The proximal end of part 102, in this way, the valve delivery device 100 can enter in the case where the swelling part 102 is in non-expansion state
Human body, and the heart valve prosthesis can be positioned in the case where the swelling part 102 is in a kind of biggish swelling state
And limit, prevent heart valve prosthesis releasing position inaccuracy and to distally dishing out, additionally it is possible in the swelling part 102
It is adherent well to heart valve prosthesis progress under a kind of lesser swelling state, it effectively prevent the hair of perivalvular leakage
It is raw.
The valve delivery device 100 further include be set to the proximal end of the conduit part 101, for controlling the centre
First control structure 103 of sheath 1011 and the opposite sliding of the outer sheath 1012, in this way, can use the first control knot
Structure 103 make the intermediate sheath 1011 and the outer sheath 1012 occur it is opposite slide, thus make the heart valve prosthesis from
Expose in the outer sheath 1012, and then is discharged into the valve diseased region of human body.
The valve delivery device 100 further include be set to the proximal end of the conduit part 101, for controlling the interior sheath
Second control structure 104 of pipe and the opposite sliding of the intermediate sheath 1011, in this way, can use second control structure
104 make the interior sheath and the intermediate sheath 1011 occur it is opposite slide, to allow the swelling part 102 described
Switch between swelling state and the non-expansion state, and then realizes the positioning and adherent function to the heart valve prosthesis.
Optionally, as shown in Fig. 2, first control structure 103 includes:
The control-rod 1031 being fixedly connected with the proximal end of the intermediate sheath 1011；
And it is sheathed on the handle jacket 1032 outside the control-rod 1031, the handle jacket 1032 and the outer sheath
1012 are fixedly connected；
Wherein, the handle jacket 1032 can the relatively described control-rod 1031 along the control-rod 1031 axial direction carry out
It is mobile, to drive the intermediate sheath 1011 and the opposite sliding of the outer sheath 1012.
In the embodiment, as shown in Fig. 2, first control structure 103 includes control-rod 1031 and handle jacket
1032, the control-rod 1031 is fixedly connected with the proximal end of the intermediate sheath 1011, thus with intermediate 1011 shape of sheath
Into a single integrated structure, the handle jacket 1032 is sheathed on outside the control-rod 1031, and is fixedly connected with outer sheath 1012, thus
With the outer sheath 1012 formed integral structure, and the handle jacket 1032 can the relatively described control-rod 1031 along the control
The axial direction of bar 1031 processed is moved.
In this way, relative motion occurs with the control-rod 1031 by controlling the handle jacket 1032, institute can be driven
Intermediate sheath 1011 and the opposite sliding of the outer sheath 1012 are stated, so as to complete the release to the heart valve prosthesis.
Optionally, as shown in Fig. 2, the control-rod 1031 is with externally threaded threaded rod；
The handle jacket 1032 has the internal screw thread cooperated with the external screw thread, when rotating the handle jacket 1032,
The handle jacket 1032 moves axially on the threaded rod.
In the embodiment, as shown in Fig. 2, the control-rod 1031 is with externally threaded threaded rod, outside the handle
Set 1032 has the internal screw thread cooperated with the external screw thread, in this way, can make the hand by rotating the handle jacket 1032
Handle housing 1032 moves axially on the threaded rod, so as to drive the intermediate sheath 1011 and the outer sheath 1012
Opposite sliding, and it is this by screw thread control that the handle jacket 1032 and the threaded rod relatively move in the way of can compared with
It precisely and slowly controls the handle jacket 1032 to move on the threaded rod, and then the epitheca can be reduced or avoided
The intermediate sheath 1011 relatively of pipe 1012 is damaged caused by human vas inner membrance when sliding.
Optionally, as shown in Fig. 2, second control structure 104 includes:
It is fixedly connected on the function handle 1041 of the proximal end of the control-rod 1031, the function handle 1041 is equipped with and pushes away
Button 10411 and three gears for switching position of the push button 10411 on the axial direction of the interior sheath, it is described in
The proximal end of sheath passes through the inside of the control-rod 1031 and the function handle 1041, and fixes and connect with the push button 10411
It connects, so that the push button 10411 when different stalls change, drives the relatively described intermediate sheath 1011 of the interior sheath to slide.
In the embodiment, as shown in Fig. 2, second control structure 104 includes being fixedly connected on the control-rod
The function handle 1041 of 1031 proximal end, wherein the proximal end of the control-rod 1031 refers on the control-rod 1031 far from institute
One end of outer sheath 1012 is stated, the function handle 1041 is equipped with push button 10411, and the proximal end of the interior sheath passes through the control
The inside of bar 1031 and the function handle 1041 processed, and be fixedly connected with the push button 10411.
It is additionally provided on the function handle 1041 for switching the push button 10411 in the axial direction of the interior sheath
Position three gears, respectively gear 0, gear 1 and gear 2, in this way, by sliding the push button 10411 to different
Gear can drive the interior sheath intermediate sheath 1011 relatively to slide, to control the swelling part 102 described
Switch between non-expansion state and the swelling state.Specifically, when the push button 10411 is in gear 0, the bulge
Part 102 is in the non-expansion state, and when the push button 10411 is in gear 1, the swelling part 102 is in lesser
Swelling state, when the push button 10411 is in gear 2, the swelling part 102 is in biggish swelling state.
In this way, second control structure 104 can control the tool of swelling part 102, there are three types of different expansion shapes
State, so as to utilize three kinds of different swelling states of the swelling part 102, to realize the positioning of the swelling part 102
With adherent function.
Optionally, as shown in Fig. 3, Fig. 4 and Fig. 5, the swelling state includes the first swelling state and the second swelling state,
And the swelling part 102 has first external diameter in first swelling state, has the in second swelling state
Two outer diameters have third outer diameter in the non-expansion state, wherein the first external diameter is greater than the second external diameter, described
Second external diameter is greater than the third outer diameter, and the third outer diameter is less than the internal diameter of the outer sheath 1012, so that in described
The swelling part 102 when non-expansion state can be placed in the outer sheath 1012.
In the embodiment, the swelling state includes the first swelling state and the second swelling state, as shown in figure 3, institute
Stating swelling part 102 has first external diameter R1 in first swelling state, as shown in figure 4, the swelling part 102 is in institute
There is second external diameter R2 when stating the second swelling state, as shown in figure 5, the swelling part 102 has in the non-expansion state
There are third outer diameter R3, and R1 > R2 > R3.The non-expansion state is that the original state of the swelling part 102 specifically works as institute
When stating push button 10411 and being in gear 0, the swelling part 102 is in the non-expansion state, when the push button 10411 is in
When gear 1, the swelling part 102 is in second swelling state, described swollen when the push button 10411 is in gear 2
Swollen component 102 is in first swelling state.
The third outer diameter is less than the internal diameter of the outer sheath 1012, in this way, the swelling part 102 is in described non-swollen
When swollen state, it can be placed in the outer sheath 1012.It should be noted that the first external diameter can be greater than the artificial heart
Internal diameter when dirty valve release conditions, in this way, entering human body in the valve delivery device 100 and determining valve diseased region
Afterwards, it can first control the swelling part 102 and be in first swelling state, so that the swelling part 102 conforms to valve
At ring, the releasing position of the heart valve prosthesis is positioned, then by the heart valve prosthesis from the outer sheath
Expose in 1012, since the outer diameter of the swelling part 102 at this time is greater than the internal diameter of the heart valve prosthesis, thus described swollen
Swollen component 102 can limit the heart valve prosthesis, prevent the heart valve prosthesis from conveying from the valve and fill
It sets and slides out to other positions in 100.
It should be noted that the second external diameter can connect with the internal diameter when heart valve prosthesis release conditions
Closely, in this way, discharging by the heart valve prosthesis to human lesion position, the swelling part 102 can be made to be located at institute
It states in the inner cavity of heart valve prosthesis, and controls the swelling part 102 in second swelling state and the unexpansive shape
Checker between state, to complete the adherent operation to the heart valve prosthesis.
Optionally, as shown in figure 3, the interior sheath is arranged in the inside of the swelling part 102, and with the bulge
The distal end of part 102 is fixedly connected, and the distal end of the proximal end of the swelling part 102 and the intermediate sheath 1011 is fixedly connected, with
When sliding the interior sheath intermediate sheath 1011 relatively, the distal end of the swelling part 102 can be drawn relative to institute
The proximal end for stating swelling part 102 moves, and the axial length of the swelling part 102 is made to change, described swollen to control
Swollen component 102 switches between first swelling state, second swelling state and the non-expansion state.
In the embodiment, as shown in figure 3, the interior sheath is arranged in the inside of the swelling part 102, and with it is described
The distal end of swelling part 102 is fixedly connected, and the distal end of the proximal end of the swelling part 102 and the intermediate sheath 1011 is fixed to be connected
It connecing, wherein the distal end of the swelling part 102 refers to one end on the swelling part 102 far from the intermediate sheath 1011,
The proximal end of the swelling part 102 refers to one end on the swelling part 102 close to the intermediate sheath 1011.The interior sheath
The distal end of pipe is then fixedly connected with the push button 10411 on the function handle 1041, and from distal end on the function handle 1041
Gear 0, gear 1 and gear 2 are disposed with to proximal end, wherein the distal end of the function handle 1041 refers to the function hand
Close to one end of the control-rod 1031 on handle 1041, the proximal end of the function handle 1041 refers on the function handle 1041
One end far from the control-rod 1031.
In this way, the swelling part 102 is in the non-expansion state when the push button 10411 is in gear 0, when
When the push button 10411 gradually switches to gear 1 and gear 2 from gear 0, the relatively described intermediate sheath of the interior sheath will be driven
1011 move to the proximal end of the conduit part 101, and can draw the distal end of the swelling part 102 to the swelling part
102 proximal end movement, so that the axial length of the swelling part 102 changes, and then can control the expansion
Component 102 can be gradually converted into second swelling state and first swelling state by the non-expansion state；Conversely,
When the push button 10411 is in gear 2, the swelling part 102 is in first swelling state, when the push button
10411 when gradually switching to gear 1 and gear 0 from gear 2, and the relatively described intermediate sheath 1011 of the interior sheath will be driven to institute
The distal movement of conduit part 101 is stated, and the distal end of the swelling part 102 can be drawn to far from the swelling part 102
The direction of proximal end moves, so that the axial length of the swelling part 102 changes, and then can control the expansion
Component 102 can gradually be converted into second swelling state and the non-expansion state by first swelling state.
Optionally, as shown in fig. 6, the swelling part 102 is cylinder-like structure, and the swelling part 102 includes N item
Deformable muscle 1021 and be connected to the deformable muscle of N item opposite end two fixing ends 1022, the N item is variable
Shape muscle 1021 is provided at circumferentially spaced along the fixing end 1022, and the both ends of every deformable muscle 1021 are equipped with the first aperture
10211, the middle part of every deformable muscle 1021 is equipped with the second aperture 10212, wherein the area of first aperture 10211 is big
In the area of second aperture 10212, N is the integer more than or equal to 3 and less than or equal to 20.
In the embodiment, as shown in fig. 6, the swelling part 102 is cylinder-like structure, and the swelling part 102
Two fixing ends 1022 including the deformable muscle 1021 of N item and the opposite end for being connected to the deformable muscle of N item, it is described
Deformable being provided at circumferentially spaced along the fixing end 1022 of muscle 1021 of N item, specifically, the number of the deformable muscle 1021 of N item
Amount can be between 3 to 20, it is preferable that the swelling part 102 in Fig. 6 includes 6 deformable muscle 1021, in this way, can
Guarantee that the swelling part 102 can preferably complete the adherent operation to the heart valve prosthesis, it also can be to a certain degree
The upper technique manufacture difficulty for reducing the swelling part 102.
As shown in fig. 6, the both ends of every deformable muscle 1021 are equipped with the first aperture 10211, every deformable muscle 1021
Middle part be equipped with the second aperture 10212, i.e. be all provided with that there are three apertures on every deformable muscle 1021, wherein first aperture
10211 area is greater than the area of second aperture 10212, in this manner it is ensured that every deformable 1021 both ends of muscle is strong
Degree is lower than the intensity at middle part, thus when the distal end of the swelling part 102 is close to the proximal end of the swelling part 102, often
The both ends of the deformable muscle 1021 of item are first bent, and the middle part of every deformable muscle 1021 is not bent, and is made at the swelling part 102
In the second swelling state as shown in Figure 4；When the proximal end to the swelling part 102 is continued in the distal end of the swelling part 102
When close, the middle part of every deformable muscle 1021 also will deform and bend, and then be in the swelling part 102 as schemed
First swelling state shown in 3.
Optionally, as shown in fig. 7, the width of every deformable 1021 end 10213 of muscle of the swelling part 102 is small
Width in middle part, first aperture 10211 and second aperture 10212 are slotted hole, first aperture 10211
Width be greater than second aperture 10212 width.
In the embodiment, as shown in fig. 7, the width of every deformable 1021 end 10213 of muscle of the swelling part 102
Degree is respectively less than the width at middle part, to guarantee that the intensity of 102 end 10213 of swelling part is lower than the intensity at middle part, in turn
Guarantee that the swelling part 102 is easier to be converted into ideal swelling state.First aperture 10211 and described second is opened
Hole 10212 is slotted hole, and the width of first aperture 10211 is greater than the width of second aperture 10212, and described first
The length of aperture 10211 can be equal to or less than the width of second aperture 10212, to both can guarantee every deformable muscle
The intensity at 1021 both ends is lower than the intensity at middle part, also can guarantee that the swelling part 102 has good deformation performance.
Optionally, as shown in Figure 1, the outer sheath 1012 includes metal tube 10121 and macromolecule woven tube 10122, institute
It states outer sheath 1012 and is fixedly connected by the macromolecule woven tube 10122 with the handle jacket 1032, the outer sheath
1012 when sliding into the distal end of the conduit part 101, and the swelling part 102 is coated by the metal tube 10121.
In the embodiment, as shown in Figure 1, the outer sheath 1012 includes metal tube 10121 and macromolecule woven tube
10122, the outer sheath 1012 is fixedly connected by the macromolecule woven tube 10122 with the handle jacket 1032.That is institute
Stating metal tube 10121 can be made of metal material, such as: the thin-wall pipes such as Nitinol, cochrome, to guarantee the gold
The wall thickness for belonging to pipe 10121 can be between 50 microns to 500 microns, and the macromolecule woven tube 10122 can be by macromolecule material
Material is made, such as: polyethylene (polyethylene, abbreviation PE), nylon etc., to guarantee that the macromolecule woven tube 10122 has
Standby good pliability.In this way, both can guarantee that the outer sheath 1012 can be by the metal tube 10121 by the bulge
Part 102 and heart valve prosthesis cladding, and it is avoided that the outer sheath 1012 due to hardness is too strong to human vas inner membrance
It causes to damage.
Preferably, in the embodiment of the present invention, the swelling part 102 can be made of Nitinol, and the expansion
The phase transition temperature of component 102 can be between 0 to 25 degree, and the wall thickness of the swelling part 102 can be micro- at 100 microns to 500
Between rice, since Nitinol has good plasticity, also there are the excellent characteristics such as wear-resistant, anticorrosive and super-elasticity, from
And it can guarantee the swelling part 102 and have good deformation performance and higher quality.
The material of the intermediate sheath 1011 can be stainless steel, such as: the line being cut by laser using Nitinol
Road composition；The control-rod 1031 and the handle jacket can be using medical polycarbonate (Polycarbonate, abbreviations
PC) plastics, acrylonitrile-butadiene-styrene (ABS) (Acrylonitrile Butadiene Styrene, abbreviation ABS) plastics or poly-
Formaldehyde (Paraformaldehyde, abbreviation POM) plastics are made.
As shown in Figure 1, the distal end of the swelling part 102 can also be fixed with cone point 105, the cone point
105 can be made of soft silica gel, and the cone point 105 can enter human body convenient for the valve delivery device 100.
Below with reference to Fig. 8 to Figure 10, the operating method of the valve delivery device 100 is illustrated:
Before heart valve prosthesis is implanted into human body, the heart valve prosthesis can be loaded into the intermediate sheath
1011 distal end, and coat the outer sheath 1012 by the heart valve prosthesis and the swelling part 102.Such as Fig. 8 institute
Show device can be there is to the distal end of the valve delivery device 100 of the heart valve prosthesis by the guidance of radiography image
Push enters the target lesion position of human body.
As shown in figure 9, the handle jacket 1032 can be rotated outward to drive the outer sheath 1012 to move to the near end,
Expose the swelling part 102 from the outer sheath 1012, the push button 10411 is then switched into gear 2, so that institute
It states swelling part 102 and is in the first swelling state, and conform at annulus, the releasing position of the heart valve prosthesis is carried out
Positioning.
As shown in Figure 10, the handle jacket 1032 can be rotated outward again with drive the outer sheath 1012 continue to
Proximal end is mobile, exposes the heart valve prosthesis 1000 from the outer sheath 1012, and is currently at first expansion
The swelling part 102 of state can limit the heart valve prosthesis 1000, the heart valve prosthesis 1000
With self-expanding and target lesion position can be conformed to.
As shown in figure 11, the push button 10411 first can be switched into gear 0, the swelling part 102 is made to be in non-swollen
Then swollen state passes through the guidance of radiography image, by the valve delivery device 100 slightly to recession so that the swelling part
102 are located in the inner cavity of the heart valve prosthesis 1000, finally directly replace the push button 10411 with gear 0 in gear 1
Switching, converts the swelling part 102 between the second swelling state and non-expansion state, to the heart valve prosthesis
1000 carry out adherent operation, and are confirmed by radiography image, guarantee that the heart valve prosthesis 1000 has good adherent effect
Fruit.
As shown in figure 12, after the completion of adherent, the push button 10411 can be switched into gear 0, and rotated inward described
Handle jacket 1032 is mobile to distal end to drive the outer sheath 1012 to continue, until the outer sheath 1012 is by the bulge
Part 102 coats, and finally withdraws from the valve delivery device 100 from human body, so far, the release of the heart valve prosthesis 1000
Process finishes.
In the embodiment of the present invention, since the valve delivery device includes swollen for being positioned to heart valve prosthesis
Swollen component, and the swelling state and non-expansion state that the swelling part has form different, thus defeated using the valve
When device being sent to convey heart valve prosthesis, the heart valve prosthesis can be positioned and be limited by the swelling part
Position, so that the heart valve prosthesis can be released into accurately diseased region, and can be released in the heart valve prosthesis
Afterwards, radial force is applied to the heart valve prosthesis using the swelling part, enables the heart valve prosthesis good
It is adherent, and then the generation of perivalvular leakage can be effectively prevented, reach preferable therapeutic effect.
The embodiment of the present invention also provides a kind of valve delivery system, including Fig. 1 is to valve as described in the examples shown in Fig. 7
Film conveying device and heart valve prosthesis.In the present embodiment, the valve delivery system can reach and Fig. 1 to reality shown in Fig. 7
The identical beneficial effect of example is applied, to avoid repeating, which is not described herein again.
The above is a preferred embodiment of the present invention, it is noted that for those skilled in the art
For, without departing from the principles of the present invention, several improvements and modifications can also be made, these improvements and modifications
It should be regarded as protection scope of the present invention.
Claims (10)
1. a kind of valve delivery device, for heart valve prosthesis to be implanted into human body, which is characterized in that the valve delivery device
Include:
Conduit part, the conduit part has for being delivered to the intracorporal distal end of people and for the proximal end for remote operation, described to lead
Pipe portion includes intermediate sheath, the outer sheath being sheathed on outside the intermediate sheath and the interior sheath being sheathed in the intermediate sheath
Pipe, the outer sheath and the interior sheath can be slided relative to the intermediate sheath, and the heart valve prosthesis is set to
The far-end, and be clipped between the intermediate sheath and the outer sheath, so that the intermediate sheath and the outer sheath phase
When to sliding, the heart valve prosthesis is released；
Swelling part for being positioned to the heart valve prosthesis, the swelling part are fixed on the intermediate sheath
Distally, swelling state and non-expansion state that the swelling part has form different, and the swelling part and the interior sheath
When pipe connection, the interior sheath and the intermediate sheath are slided relatively, the swelling part can be controlled in the swelling state
Change between the non-expansion state；
Be set to the proximal end of the conduit part, for control the intermediate sheath it is opposite with the outer sheath sliding first control
Structure processed；
And be set to the conduit part proximal end, for controlling the opposite sliding of the interior sheath and the intermediate sheath the
Two control structures.
2. valve delivery device according to claim 1, which is characterized in that first control structure includes:
The control-rod being fixedly connected with the proximal end of the intermediate sheath；
And it is sheathed on the handle jacket outside the control-rod, the handle jacket is fixedly connected with the outer sheath；
Wherein, the handle jacket can be moved relative to the control-rod along the axial direction of the control-rod, described in driving
The sliding opposite with the outer sheath of intermediate sheath.
3. valve delivery device according to claim 2, which is characterized in that the control-rod is with externally threaded screw thread
Bar；
The handle jacket has the internal screw thread cooperated with the external screw thread, when rotating the handle jacket, the handle jacket
It is moved axially on the threaded rod.
4. valve delivery device according to claim 3, which is characterized in that second control structure includes:
It is fixedly connected on the function handle of the proximal end of the control-rod, the function handle is described equipped with push button and for switching
Three gears of position of the push button on the axial direction of the interior sheath, the proximal end of the interior sheath pass through the control-rod and
The inside of the function handle, and being fixedly connected with the push button, so that the push button is when different stalls change, described in drive
The relatively described intermediate sheath sliding of interior sheath.
5. valve delivery device according to any one of claim 1 to 4, which is characterized in that the swelling state includes
First swelling state and the second swelling state, and the swelling part has first external diameter in first swelling state,
There is second external diameter when second swelling state, there is third outer diameter in the non-expansion state, wherein outside described first
Diameter is greater than the second external diameter, and the second external diameter is greater than the third outer diameter, and the third outer diameter is less than the outer sheath
Internal diameter so that be in the non-expansion state when the swelling part can be placed in the outer sheath.
6. valve delivery device according to claim 5, which is characterized in that the interior sheath is arranged in the swelling part
Inside, and be fixedly connected with the distal end of the swelling part, the distal end of the proximal end of the swelling part and the intermediate sheath
It is fixedly connected, when so that the interior sheath intermediate sheath relatively being slided, the distal end that can draw the swelling part is opposite
It is moved in the proximal end of the swelling part, the axial length of the swelling part is made to change, to control the expansion
Component switches between first swelling state, second swelling state and the non-expansion state.
7. valve delivery device according to claim 6, which is characterized in that the swelling part is cylinder-like structure, and
The swelling part include the deformable muscle of N item and be connected to the deformable muscle of N item opposite end two fixing ends,
The deformable muscle of N item being provided at circumferentially spaced along the fixing end, the both ends of every deformable muscle are equipped with the first aperture, often
The middle part of the deformable muscle of item is equipped with the second aperture, wherein the area of first aperture is greater than the area of second aperture, N
For the integer more than or equal to 3 and less than or equal to 20.
8. valve delivery device according to claim 7, which is characterized in that the deformable muscle end of every of the swelling part
The width in portion is respectively less than the width at middle part, and first aperture and second aperture are slotted hole, first aperture
Width is greater than the width of second aperture.
9. valve delivery device according to any one of claim 2 to 4, which is characterized in that the outer sheath includes gold
Belong to pipe and macromolecule woven tube, the outer sheath is fixedly connected by the macromolecule woven tube with the handle jacket, described
When outer sheath slides into the distal end of the conduit part, the swelling part is by the metal tube clad.
10. a kind of valve delivery system, which is characterized in that including valve delivery device described in any one of claims 1 to 9
And heart valve prosthesis.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810295492.XA CN110314016B (en) | 2018-03-30 | 2018-03-30 | Valve conveying device and conveying system thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810295492.XA CN110314016B (en) | 2018-03-30 | 2018-03-30 | Valve conveying device and conveying system thereof |
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| CN110314016A true CN110314016A (en) | 2019-10-11 |
| CN110314016B CN110314016B (en) | 2024-02-27 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2021227856A1 (en) * | 2020-05-09 | 2021-11-18 | 杭州德诺睿华医疗科技有限公司 | Cutting device and cutting system |
| WO2022007714A1 (en) * | 2020-07-06 | 2022-01-13 | 杭州启明医疗器械股份有限公司 | Sheath tube and sheath tube assembly used for delivering interventional instrument |
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| CN104968300A (en) * | 2013-02-06 | 2015-10-07 | 西美蒂斯股份公司 | Prosthetic valve, delivery apparatus and delivery method |
| US20170325951A1 (en) * | 2016-05-16 | 2017-11-16 | Boston Scientific Scimed, Inc. | Sheathing aid |
| CN209032745U (en) * | 2018-03-30 | 2019-06-28 | 康迪泰科(北京)医疗科技有限公司 | A kind of valve delivery device and its transportation system |
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| CN102573703A (en) * | 2009-08-27 | 2012-07-11 | 麦德托尼克公司 | Transcatheter valve delivery systems and methods |
| CN103118630A (en) * | 2010-09-24 | 2013-05-22 | 西美蒂斯股份公司 | Stent valve, delivery apparatus and method therefor |
| CN104968300A (en) * | 2013-02-06 | 2015-10-07 | 西美蒂斯股份公司 | Prosthetic valve, delivery apparatus and delivery method |
| US20170325951A1 (en) * | 2016-05-16 | 2017-11-16 | Boston Scientific Scimed, Inc. | Sheathing aid |
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| WO2022007714A1 (en) * | 2020-07-06 | 2022-01-13 | 杭州启明医疗器械股份有限公司 | Sheath tube and sheath tube assembly used for delivering interventional instrument |
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|---|---|
| CN110314016B (en) | 2024-02-27 |
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