CN117462830B - Valve balloon dilation catheter and valve replacement system - Google Patents
Valve balloon dilation catheter and valve replacement system Download PDFInfo
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- CN117462830B CN117462830B CN202311813596.2A CN202311813596A CN117462830B CN 117462830 B CN117462830 B CN 117462830B CN 202311813596 A CN202311813596 A CN 202311813596A CN 117462830 B CN117462830 B CN 117462830B
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- 230000010339 dilation Effects 0.000 title claims abstract description 51
- 238000003384 imaging method Methods 0.000 claims abstract description 25
- 238000007789 sealing Methods 0.000 claims abstract description 24
- 238000004804 winding Methods 0.000 claims abstract description 7
- 238000002601 radiography Methods 0.000 claims description 18
- 239000000463 material Substances 0.000 claims description 10
- 238000012800 visualization Methods 0.000 claims description 6
- 229920001971 elastomer Polymers 0.000 claims description 5
- 230000007704 transition Effects 0.000 claims description 5
- 229920002614 Polyether block amide Polymers 0.000 claims description 3
- 238000004891 communication Methods 0.000 claims description 3
- 239000004433 Thermoplastic polyurethane Substances 0.000 claims description 2
- 239000000806 elastomer Substances 0.000 claims description 2
- 210000001503 joint Anatomy 0.000 claims description 2
- 229920002803 thermoplastic polyurethane Polymers 0.000 claims description 2
- 238000000034 method Methods 0.000 abstract description 9
- 210000005077 saccule Anatomy 0.000 abstract description 4
- 230000000916 dilatatory effect Effects 0.000 abstract description 3
- 210000005240 left ventricle Anatomy 0.000 description 19
- 210000001765 aortic valve Anatomy 0.000 description 13
- 210000003128 head Anatomy 0.000 description 11
- 210000004115 mitral valve Anatomy 0.000 description 11
- 239000002872 contrast media Substances 0.000 description 7
- 210000002376 aorta thoracic Anatomy 0.000 description 6
- 239000007788 liquid Substances 0.000 description 5
- 239000012530 fluid Substances 0.000 description 4
- 210000001105 femoral artery Anatomy 0.000 description 3
- 208000018578 heart valve disease Diseases 0.000 description 3
- 241000446313 Lamella Species 0.000 description 2
- 206010067171 Regurgitation Diseases 0.000 description 2
- 210000004351 coronary vessel Anatomy 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 210000003709 heart valve Anatomy 0.000 description 2
- 208000005907 mitral valve insufficiency Diseases 0.000 description 2
- -1 polyethylene terephthalate Polymers 0.000 description 2
- 238000010992 reflux Methods 0.000 description 2
- 239000007779 soft material Substances 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 229920000299 Nylon 12 Polymers 0.000 description 1
- 239000004721 Polyphenylene oxide Substances 0.000 description 1
- 206010052428 Wound Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 125000002252 acyl group Chemical group 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 210000000709 aorta Anatomy 0.000 description 1
- 210000000702 aorta abdominal Anatomy 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
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- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
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- 238000002513 implantation Methods 0.000 description 1
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- 150000003951 lactams Chemical class 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
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- 229920000570 polyether Polymers 0.000 description 1
- 229920000139 polyethylene terephthalate Polymers 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1002—Balloon catheters characterised by balloon shape
-
- 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
- A61F2/243—Deployment by mechanical expansion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1018—Balloon inflating or inflation-control devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1079—Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
Abstract
The invention discloses a valve saccule dilating catheter and a valve replacement system. The valve balloon dilation catheter comprises a balloon, a catheter and a functional tube; the catheter has a first guidewire lumen and a first ostomy lumen; the catheter is connected with the proximal end of the saccule in a sealing way; the functional tube comprises a contrast section and a flexible supporting section connected with the distal end of the contrast section, the proximal end of the contrast section is connected with the distal end of the balloon in a sealing way, a contrast hole exposing the balloon is arranged on the contrast section, and the contrast hole is communicated with the first imaging cavity; the flexible support section is provided with a second guide wire cavity which penetrates from the proximal end to the distal end of the flexible support section and is communicated with the first guide wire cavity, and the flexible support section is in a winding state in a natural state. The valve replacement system includes a guidewire, a balloon-expandable valve prosthesis, and the valve balloon dilation catheter. The invention can simplify the operation process, reduce the operation consumable cost and improve the trafficability of the valve saccule dilating catheter.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a valve balloon dilation catheter and a valve replacement system.
Background
With aging population, the incidence rate of valvular heart disease is obviously increased, and the traditional surgical treatment is still the first treatment means for most patients with severe valvular disease at present, but the risks of large wounds, high postoperative mortality, more complications and the like exist. In recent years, transcatheter valve replacement/repair operations are mature and widely applied, especially the evidence-based basis of transcatheter aortic valve replacement operations is relatively sufficient, the trauma is greatly reduced, recommendations of European and American heart valve disease treatment guidelines are obtained, and the transcatheter valve replacement/repair operations are the milestone progress in the field of heart valve disease interventional treatment.
Balloon expandable valve prostheses (also known as balloon expandable valves) for replacing a native valve, such as an aortic valve, require the use of a valve balloon expandable catheter for expansion, and also require the use of a valve balloon expandable catheter for pre-expanding the native valve prior to implantation of the valve prosthesis. However, in existing valve replacement systems, such as aortic valve replacement systems, after the valve prosthesis is released through balloon dilation, only an imaging passageway can be provided through an imaging catheter pre-arranged at the sinus orifice of the coronary artery to observe the aortic blood flow and the condition of the coronary artery branch, so that whether the mitral valve structure is affected after the valve prosthesis is implanted or not and whether the condition of the mitral valve regurgitation is inconvenient to observe are inconvenient, and it is often necessary to reestablish an imaging passageway to the left ventricle to carry out imaging observation after the valve balloon dilation catheter is withdrawn, so as to determine whether the implanted valve prosthesis affects the mitral valve structure and observe the condition of the mitral valve regurgitation. Therefore, the existing valve saccule dilating catheter is adopted, the operation process is complicated, the operation time is prolonged, and the operation consumable cost is increased.
In addition, valve balloon dilation catheters are relatively resistant during pushing, requiring the use of super-hard guide wires to establish the trajectory of the femoral artery to the left ventricle. According to the aortic arch anatomical structure of a human body, as the curvature radius from the descending aorta to the ascending aorta is smaller, the valve balloon dilation catheter has difficulty in following the super-hard guide wire, and particularly when the super-hard guide wire spans an aortic valve (can be called a valve crossing), an operator needs to be skillfully operated to adjust the winding form of the distal end of the super-hard guide wire, so that the super-hard guide wire can be well attached to the heart apex position of the left ventricle to form a strong support, and the balloon can smoothly span the valve. Thus, the transvalve delivery process of existing valve balloon dilation catheters is difficult and requires a high level of skill on the part of the operator.
Disclosure of Invention
In view of the above, the present invention provides a valve balloon dilation catheter and a valve replacement system to solve the above-mentioned problems.
In a first aspect, the present invention provides a valve balloon dilation catheter comprising a balloon, a catheter, and a functional tube. The catheter has a first guidewire lumen and a first guidewire lumen; the catheter is in sealing connection with the proximal end of the balloon; the functional tube comprises a radiography section and a flexible supporting section connected with the distal end of the radiography section, the proximal end of the radiography section is connected with the distal end of the balloon in a sealing way, the radiography section is provided with a radiography hole exposing the balloon, and the radiography hole is communicated with the first radiography cavity; the flexible support section has a second guidewire lumen extending therethrough from a proximal end to a distal end thereof and communicating with the first guidewire lumen, the flexible support section being in a coiled state in a natural state.
In a second aspect, the present invention also provides a valve replacement system comprising a balloon expandable valve prosthesis, a guidewire, and a valve balloon dilation catheter as described above. The balloon expandable valve prosthesis is mounted on the balloon in a radially compressed state; under the working state: the first guide wire cavity and the second guide wire cavity are sleeved on the guide wire. In one embodiment, the flexible support section enters the left ventricle along the guidewire, the flexible support section cooperates with the guidewire to provide support for the pushing of the balloon and the balloon-expandable valve prosthesis; after the balloon expands the balloon-expanded valve prosthesis, contrast liquid can be infused into the left ventricle through the contrast section so as to observe and judge whether the implanted balloon-expanded valve prosthesis affects the mitral valve structure and observe the reflux condition of the mitral valve.
According to the valve balloon dilation catheter and the valve replacement system, the functional tube is additionally arranged, the radiography section of the functional tube is connected with the far end of the balloon in a sealing mode, the radiography section is provided with the radiography hole exposing the balloon, and after the balloon is dilated by the balloon dilation valve prosthesis, contrast liquid can be infused through the radiography section, so that the operation process can be simplified, the operation time can be saved, and the operation consumable cost can be reduced. In addition, the function pipe has be winding state the flexible support section, flexible support section cooperation seal wire can be for the propelling movement of sacculus provides stronger support, has improved the trafficability characteristic of valve sacculus dilatation pipe, not only can shorten the sacculus is striden the time of lamella, improves operation efficiency, and the operation is comparatively simple moreover.
Drawings
In order to more clearly illustrate the embodiments of the invention or the technical solutions of the prior art, the drawings which are used in the description of the embodiments or the prior art will be briefly described, it being obvious that the drawings in the description below are only some embodiments of the invention, and that other drawings can be obtained according to these drawings without inventive faculty for a person skilled in the art.
Fig. 1 is a schematic view of a superhard guidewire in an operating state in a valve replacement system according to an embodiment of the present invention.
Fig. 2a is a schematic view of the valve replacement system according to an embodiment of the present invention.
Fig. 2b is a schematic view of a valve balloon dilation catheter provided in an embodiment of the present invention in another operational scenario.
Fig. 3 is a schematic diagram of the overall structure of a valve balloon dilation catheter provided by an embodiment of the present invention.
Fig. 4 is a cross-sectional view of the catheter of the valve balloon dilation catheter of fig. 3 taken along line IV-IV.
Fig. 5 is a schematic structural view of the inner tube of the valve balloon dilation catheter of fig. 3.
Fig. 6 is an axial cross-sectional view of the distal end of the valve balloon dilation catheter of fig. 3.
Fig. 7 is an enlarged view at I in fig. 6.
Fig. 8 is an enlarged view of the first embodiment at II in fig. 6.
Fig. 9 is an enlarged view of the second embodiment at II in fig. 6.
Fig. 10 is an axial cross-sectional view of the proximal end of the valve balloon dilation catheter of fig. 6.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
In the technical field of interventional medical devices, the end of the device close to the operator during surgery is generally referred to as a proximal end, and the end of the device remote from the operator is generally referred to as a distal end. "axial" refers to a direction parallel to the line connecting the proximal and distal centers. "radial" refers to a direction perpendicular or substantially perpendicular to the axial direction. "circumferential" refers to a direction about the axial direction. "central axis" refers to the center line of the proximal and distal ends. Moreover, the use of the terms first, second, etc. do not denote any order or importance, but rather the terms first, second, etc. are used to distinguish one element from another.
It is to be understood that the terminology used in the description and claims of the invention is for the purpose of describing particular embodiments only, and is not intended to be limiting of the invention. The singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The term "comprising" and any variations thereof is intended to cover a non-exclusive inclusion. Furthermore, the present invention may be embodied in many different forms and is not limited to the embodiments described in the present embodiment. The following specific examples are provided to facilitate a more thorough understanding of the present disclosure, in which terms indicating orientations of the components, up, down, left, right, etc., are merely for the locations of the illustrated structures in the corresponding drawings.
Referring to fig. 1, 2a and 2b, the valve replacement system 1000 provided by the present invention includes a supporting guidewire 100, a balloon expandable valve prosthesis 200 and a valve balloon dilation catheter 300, wherein the supporting guidewire 100 may be a super-hard guidewire 100 commonly used in the industry.
As shown in connection with fig. 3-6, the valve balloon dilation catheter 300 includes a balloon 10, a catheter 20, and a functional tube 30. The catheter 20 comprises a first guidewire lumen 201 and a first imaging lumen 202, preferably the first guidewire lumen 201 and the first imaging lumen 202 extend through the catheter 20 in the axial direction. The balloon 10 includes oppositely disposed distal and proximal seal segments 11, 12. The catheter 20 is sealingly connected to the proximal sealing section 12 of the balloon 10. The functional tube 30 comprises a contrast segment 31 and a flexible support segment 33 connected to the distal end of the contrast segment 31. The proximal seal of contrast segment 31 is coupled to distal seal segment 11 of balloon 10. The contrast segment 31 is provided with a contrast hole 3101 exposing the balloon 10. The contrast aperture 3101 communicates with the first imaging lumen 202. The flexible support section 33 has a second guidewire lumen 301 extending therethrough from its proximal end to its distal end and communicating with the first guidewire lumen 201 (see fig. 6), preferably the second guidewire lumen 301 extends axially through the flexible support section 33. As shown in fig. 3 and 6, in the natural state, the flexible support section 33 is in a rolled state, i.e., the flexible support section 33 does not extend in a straight line, but is curled about a centerline that is perpendicular or nearly perpendicular to the axis of the catheter 20 and balloon 10, and the curl may be coplanar with the axis of the catheter 20 and balloon 10.
The balloon expandable valve prosthesis 200 may be mounted in a radially compressed state on the balloon 10 of the valve balloon dilation catheter 300. In the working state, the first guide wire cavity 201 and the second guide wire cavity 301 are sleeved on the superhard guide wire 100. Taking the example of a balloon expandable valve prosthesis 200 replacing a native aortic valve, the flexible support section 33 can be fitted with a super-hard guidewire 100 into the left ventricle; after the balloon expandable valve prosthesis 200 spans the valve, the contrast segment 31 also enters the left ventricle. Because the contrast segment 31 is provided with the contrast hole 3101 exposing the balloon 10, the contrast hole 3101 is communicated with the first contrast cavity 202 axially penetrating the catheter 20, and after the balloon-expanded valve prosthesis 200 is expanded and released by the balloon 10, contrast liquid can be infused into the left ventricle through the contrast segment 31, so that an operator can observe and judge whether the implanted balloon-expanded valve prosthesis 200 affects the mitral valve structure, observe the reflux condition of the mitral valve and the like, and the operator does not need to reestablish a contrast passage to the left ventricle to observe after the valve balloon-expanded catheter is withdrawn like the prior art, thereby simplifying the operation process, saving the operation time and reducing the operation consumable cost. In addition, be provided with the flexible support section 33 that is the winding state under the natural state on the function pipe 30, flexible support section 33 gets into the left ventricle along superhard guide wire 100, flexible support section 33 cooperates with superhard guide wire 100, can provide stronger support for the propelling movement of sacculus 10 and ball expansion valve prosthesis 200 to improve the trafficability characteristic of valve sacculus expansion pipe 300, not only can shorten the time that sacculus 10 and ball expansion valve prosthesis 200 strided the lamella, improve the operating efficiency, the operation is comparatively simple moreover.
It should be noted that the term "natural state" refers to a state in which the flexible support section 33 is independent of the superhard guide wire 100, i.e. not sleeved on the superhard guide wire 100 and not constrained by other elements. The term "operational state" refers to a state in which the valve replacement system 1000 is placed into a patient, and in particular, the operational state may include a stage of delivering the balloon expandable valve prosthesis 200 and the valve balloon expandable catheter 300 or delivering the valve balloon expandable catheter 300 alone, a stage of expanding the balloon expandable valve prosthesis 200 to expand a native valve or the balloon expandable valve prosthesis 200, a visualization stage, and the like.
It will be appreciated by those skilled in the art that fig. 2a is merely an example of a valve replacement system 1000 and is not intended to be limiting of the valve replacement system 1000, and that the valve replacement system 1000 may include more components than shown in fig. 2a, or may combine certain components, or different components, e.g., the valve replacement system 1000 may further include a steering handle or the like for driving the balloon-expandable valve prosthesis 200 and the valve balloon dilation catheter 300 in the direction of extension of the super-hard guidewire.
As shown in fig. 2a, the distal end of the superhard guidewire 100 is provided with a coiled structure 101. In particular, the distal end of the coiled structure 101 is coiled at least approximately one revolution so that the ultra-hard wire 100 can fit at the apex of the left ventricle LV to provide support for the advancement of the balloon 10 and the balloon expandable valve prosthesis 200. The existing material of the medical super-hard guide wire is suitable for the material of the super-hard guide wire 100 of the present invention, and the present invention is not particularly limited. In this embodiment, a super hard wire of 0.035 "gauge is preferred.
The balloon expandable valve prosthesis 200 refers to a radially compressible, expandable prosthetic heart valve that is implanted in a patient's heart by balloon expansion to replace a native heart valve that presents with severe lesions, such as aortic valve AV. The balloon expandable valve prosthesis 200 may be an existing balloon expandable valve prosthesis, and the present invention will not be described in detail.
Of course, the valve balloon dilation catheter 300 can be used not only to dilate the balloon dilation valve prosthesis 200, but also as shown in fig. 2b, the valve balloon dilation catheter 300 can be used alone, and the valve balloon dilation catheter 300 can be delivered such that after the balloon 10 spans the valve, the balloon 10 is further dilated to pre-dilate or further dilate the native diseased valve such as aortic valve AV.
As shown in fig. 3, the balloon 10 further includes a working section 13 (the working section 13 is generally cylindrical after the balloon has been inflated and expanded) and two tapered sections 14 connected to opposite ends of the working section 13, the tapered sections 14 respectively connecting the distal seal section 11 and the proximal seal section 12. The balloon 10 may be configured and dimensioned according to clinical requirements. Alternatively, the balloon 10 may be classified into specifications of 20mm, 23mm, 26mm, 29mm, etc. according to the diameter of the working section. The materials of balloon 10 may include, but are not limited to, conventional balloon materials such as polylaurolactam, segmented polyether amide, polyurethane, polyethylene terephthalate, and the like. The diameter and length dimensions of the balloon 10 may be tailored to the size requirements of the balloon-expandable valve prosthesis 200 or to the appropriate pre-expanded dimensions of the native diseased valve. The balloon forming process uses a tube to stretch and blow mold the balloon, which may be hot air or laser welded to the catheter 20. The catheter 20 provides at least one passageway through which the balloon may be inflated to expand the balloon expandable valve prosthesis 200 or to pre-expand a native diseased valve.
In the present embodiment, the contrast segment 31 and the flexible support segment 33 of the functional tube 30 are integrally formed, so that the assembly efficiency of the whole valve balloon dilation catheter 300 can be improved. In some embodiments, contrast segment 31 may be fixedly attached to flexible support segment 33, the manner of the fixed attachment being not limited to adhesive, welding, or the like.
In this embodiment, in the natural state, the flexible support section 33 is curled in a pigtail shape. In particular, the distal end of the flexible support section 33 is provided with a winding structure 331. In said natural state, the flexible support section 33 is wound at least one turn, i.e. the number of turns of the winding structure 331 comprises at least one turn, preferably the flexible support section 33 is wound 1-2 turns.
The flexible support section 33 is made of a soft material having elasticity. The shore hardness of the elastic soft material is preferably in the range of 60A-90A. The flexible material having elasticity includes, but is not limited to, at least one of block polyether amide, thermoplastic polyurethane elastomer rubber. Because the flexible support segment 33 has better compliance and elasticity, the flexible support segment 33 is able to conform to the coiled structure 101 of the distal end of the super-hard wire 100 during the process of the flexible support segment 33 following the super-hard wire 100.
The outer diameter of the flexible support section 33 gradually decreases from the proximal end to the distal end of the flexible support section 33, and the distal end of the flexible support section 33 is provided with a tapered transition head or TIP head 332, thereby improving the smoothness of the flexible support section 33 traveling. The outer surface of the tapered transition head 332 smoothly transitions with the exposed surface of the ultra-hard wire 100 as the ultra-hard wire 100 is threaded into the flexible support section 33.
Because of the good compliance and tracking of the flexible support section 33, the flexible support section 33 is relatively easy to traverse the aortic valve AV with the ultra-hard wire 100. When the flexible support segment 33 is fully passed over the aortic valve AV into the left ventricle LV, at which point the balloon expandable valve prosthesis 200 radially compressed on the balloon 10 is in the descending aorta, the flexible support segment 33 is sleeved outside the super-hard wire 100, which tends to revert to its natural state, thereby enabling the super-hard wire 100 to be affected to enhance the coiling and support properties of the distal end of the super-hard wire 100, whereby the balloon 10 and the balloon expandable valve prosthesis 200 are more likely to pass over the aortic arch, reach the aortic valve AV site and achieve valve crossing (as shown in fig. 2 a). After the balloon expandable valve prosthesis 200 spans the valve, the flexible support section 33 is sleeved outside the distal end of the superhard guide wire 100, and the two are matched to be propped against the apex of the heart in a pig tail shape to provide axial support for the valve balloon expandable catheter 300, so that when the balloon 10 is inflated to expand the balloon expandable valve prosthesis 200 or pre-expand the native diseased valve, the displacement of the balloon 10 can be avoided to continuously expand the balloon expandable valve prosthesis 200 or the native diseased valve at a predetermined position.
Referring to fig. 3 to 5, the catheter 20 includes an inner tube 21 and an outer tube 23 sleeved outside the inner tube 21 and radially spaced from the inner tube 21. The proximal sealing section 12 of the balloon 10 is sealingly connected to the outer tube 23. A balloon inflation lumen 203 is formed between the inner tube 21 and the outer tube 23 in communication with the interior of the balloon 10. The inner tube 21 axially extends through a first guide wire lumen 201 and a first contrast lumen 202 radially spaced from the first guide wire lumen 201 and communicating with the contrast hole 3101.
Wherein, the inner tube 21 and the outer tube 23 are made of polymer materials. The polymeric material includes, but is not limited to, at least one of a polydodecyl lactam and a block polyether acyl. The materials of the catheter in the prior art are suitable for the inner tube 21 and the outer tube 23 of the present invention, and will not be described in detail herein. The materials of the inner tube 21 and the outer tube 23 may be the same or different.
The first guide wire cavity 201 extends along the central axis of the inner tube 21, the first imaging cavity 202 extends parallel to the central axis of the inner tube 21, and the first imaging cavity 202 is arranged at the periphery of the first guide wire cavity 201 and circumferentially. The number of contrast holes 3101 and the number of first imaging lumens 202 may each comprise one or more. The plurality of first imaging lumens 202 are uniformly arranged along the circumferential direction of the first guidewire lumen 201, and the plurality of imaging holes 3101 are uniformly arranged along the circumferential direction of the imaging section 31 to increase the infusion speed of the imaging fluid. Optionally, a plurality of first ostomy lumens 202 are symmetrically arranged about the central axis of the first guidewire lumen 201. The radial cross-section of the first contrast chamber 202 is substantially fan-shaped, thereby increasing the cross-sectional area of the first contrast chamber 202 and thereby increasing the contrast agent output efficiency. The plurality of contrast holes 3101 are arranged at intervals, and the longitudinal direction of the contrast holes 3101 is parallel to the central axis of the contrast segment 31. The shape of the contrast aperture 3101 may include at least one of a circle, an ellipse, a rectangle, or a polygon.
After the balloon 10 completes filling and expanding the balloon expandable valve prosthesis 200 or the native valve, the contrast medium can be directly infused into the left ventricle through the first imaging lumen 202 and the contrast hole 3101 communicated with the first imaging lumen 202, so that an operator can observe and judge whether the expansion of the implanted balloon expandable valve prosthesis 200 or the native valve affects the mitral valve structure and observe the regurgitation condition of the mitral valve, and the like, thereby providing a timely image reference for making subsequent treatment measures.
Referring to fig. 6-7 together, in this embodiment, the proximal seal segment 12 of the balloon 10 is sealingly connected to the outer tube 23 by a seal 24. In other embodiments, the outer tube 23 may be directly sealingly embedded within the proximal sealing section 12 of the balloon 10. Specifically, the seal 24 is sleeved outside the proximal seal segment 12 of the balloon 10 and the distal end of the outer tube 23. In this embodiment, a balloon inflation channel 1201 is formed between the proximal sealing section 12 of the balloon 10 and the inner tube 21 in communication with the balloon inflation lumen 203 to inflate the balloon 10. A plurality of axially extending supports 231 are provided between the inner tube 21 and the outer tube 23 to provide for the inner tube 21 and the outer tube 23 to be spaced apart in the radial direction of the catheter 20 to form a balloon filling chamber 203 between the inner tube 21 and the outer tube 23. It will be appreciated that support 231 is axially provided with a lumen communicating with balloon inflation lumen 203 for the flow of inflation 10 balloon fluid therethrough. A support 231 extending beyond the distal end of the outer tube 23 is sealingly connected to the proximal sealing section 12 of the balloon 10, ensuring tightness between the outer tube 23 and the proximal sealing section 12 of the balloon 10. In other embodiments, the distal end of the outer tube 23 may also abut directly against the proximal seal segment 12.
Referring to fig. 6 to 8, the contrast section 31 of the functional tube 30 is provided with a first spacing cavity 3102 extending through the second guide wire cavity 301 along the axial direction, the inner tube 21 is embedded in the first spacing cavity 3102 in a sealing manner, and the first guide wire cavity 201 and the second guide wire cavity 301 can be in butt joint in a sealing manner. Optionally, the inner wall of the first guidewire lumen 201 is flush with the inner wall of the second guidewire lumen 301 so as not to obstruct the super-hard guidewire 100 from passing through the first guidewire lumen 201 and the second guidewire lumen 301, thereby improving the smoothness of the valve balloon dilation catheter 300 traveling along the super-hard guidewire.
Referring to fig. 5, in this embodiment, the inner tube 21 includes a main body section 211 and an extension section 212 extending out of the distal end of the main body section 211. The outer diameter of the body section 211 is greater than the outer diameter of the extension section 212. The first guidewire lumen 201 extends through the main body section 211 and the extension section 212. The first ostomy chamber 202 extends through the main body section 211. The contrast segment 31 is provided with a second spacing chamber 3103 extending through the first spacing chamber 3102 in the axial direction. The distal end of the body segment 211 is sealingly nested within the proximal end of the first spacing lumen 3102. The distal end of the extension 212 is sealingly embedded within the second spacing cavity 3103.
Extension segment 212 encloses, together with the distal end of main body segment 211 and contrast segment 31, a second contrast chamber 3104 that communicates with first contrast chamber 202 and contrast bore 3101. In this embodiment, the distal end of the main body section 211 is correspondingly located at the connection between the contrast segment 31 and the distal sealing segment 11 of the balloon 10, and the extension segment 212 is exposed at the contrast hole 3101, so as to ensure that the outflow amount of the contrast agent is sufficient. Optionally, the projection of the contrast hole 3101 on an axial projection plane parallel to the central axis of the inner tube 21 is arranged in line with the projection of the distal sealing section 11 of the balloon 10 on said axial projection plane, and the contrast agent flowing out of the first imaging lumen 202 can flow out of the contrast hole 3101 rapidly. In some variant embodiments, the projection of the contrast hole 3101 on an axial projection plane parallel to the central axis of the inner tube 21 may be spaced apart from the projection of the distal sealing section 11 of the balloon 10 on said axial projection plane.
The first spacing cavity 3102 and the second spacing cavity 3103 are coaxially disposed and are disposed in a stepped configuration, with the radial dimension of the first spacing cavity 3102 being greater than the radial dimension of the second spacing cavity 3103. Specifically, the contrast segment 31 includes a straight segment 311, and a first cone head 312 and a second cone head 313 disposed at opposite ends of the straight segment 311, the second cone head 313 is connected to the flexible support segment 33, the first spacing cavity 3102 axially penetrates the first cone head 312 and the straight segment 311, and the second spacing cavity 3103 is disposed in the second cone head 313, so that a distal end of the extension segment 212 abuts against a proximal end of the flexible support segment 33, thereby avoiding leakage of contrast agent in the second contrast cavity 3104 into the second guidewire cavity 301. The second cone head 313 is in smooth transition connection with the flexible support section 33, so that the smoothness of the transvalvular performance of the functional tube 30 is improved, and the design of the first cone head 312 facilitates the assembly of the contrast section 31 with the distal sealing section 11 of the balloon 10.
Referring to fig. 6 and 9 together, in some embodiments, the inner tube 21 is provided with an opening 210. The opening 210 extends through the contrast hole 3101 and the first imaging lumen 202. Specifically, the distal end of the inner tube 21 does not include an extension section, and the contrast section 31 is provided with only the first spacing lumen 3102 in the axial direction. The distal end of inner tube 21 directly abuts the proximal end of second cone head 313 of contrast segment 31.
Referring to fig. 3 and 10 together, the valve balloon dilation catheter 300 further includes a catheter hub 40 disposed at the proximal end of the catheter 20. The catheter hub 40 is provided with a guidewire port 401 communicating with the first guidewire lumen 201, an contrast port 402 communicating with the first catheter lumen 202, and an inflation port 403 communicating with the inflation lumen of the balloon 10.
The super-hard guidewire 100 passes through the guidewire port 401, the first guidewire lumen 201, and the second guidewire lumen 301 in sequence so that the valve balloon dilation catheter 300 may travel along the super-hard guidewire 100 into the patient's heart. Contrast medium flows from the contrast port 402 into the first and second imaging lumens 202, 3104 and out of the imaging bore 3101, thereby infusing contrast medium into the left ventricle after the balloon 10 expands the balloon-expandable valve prosthesis 200 or expands the native diseased valve. Inflation port 403 and balloon inflation lumen 203 form a channel for inflating or deflating balloon 10 to effect the inflation or deflation of balloon 10 by the inflation or deflation of liquid or gas into balloon 10. Specifically, inflation port 403 may be connected to an external pressure pump, and liquid or gas may enter or exit the interior of balloon 10 via inflation port 403 and balloon inflation lumen 203 to effect inflation or deflation of balloon 10. It will be appreciated that one or more filling lumens may be provided within the interior of catheter 20.
Specifically, in the present embodiment, the proximal end of the catheter hub 40 is provided with a first branch lumen 41 communicating with the first guidewire lumen 201 and the guidewire port 401, a second branch lumen 42 communicating with the first imaging lumen 202 and the imaging port 402, and a third branch lumen 43 communicating with the balloon 10 and the filling lumen of the filling port 403. The inner tube 21 further comprises an extension 212 extending out of the proximal end of the main body section 211, the extension 212 being sealingly connected to the first branch lumen 41.
In this embodiment, the distal end of catheter hub 40 is sealingly connected to outer tube 23 of catheter 20. Optionally, the valve balloon dilation catheter 300 further includes a buffer member 50 that is sleeved over the outer tube 23 and the distal end of the catheter hub 40 to avoid stress concentrations at the connection of the catheter 20 to the catheter hub 40 and to prevent the catheter 20 from breaking at that connection. The cushioning member 50 may be made of an elastic material such as, but not limited to, rubber.
The use of the valve replacement system 1000 of the present invention includes the steps of:
the first step: referring to fig. 1, after a small incision is made by the puncture of the femoral artery of a patient, a guide wire is sequentially delivered to the left ventricle through the femoral artery, the abdominal aorta, the thoracic aorta, and the aortic arch in combination with a catheter (not shown), and then the super-hard guide wire 100 is exchanged and withdrawn, creating an orbit from outside the body to inside the body.
And a second step of: referring to fig. 2a, the valve balloon dilation catheter 300 is sleeved over the super hard guidewire 100 and pushed so that the flexible support segment 33 of the valve balloon dilation catheter 300 passes across the aortic valve into the left ventricle.
And a third step of: continuing to push the valve balloon dilation catheter 300, the balloon expandable valve prosthesis 200 disposed on the valve balloon dilation catheter 300 is moved across the aortic valve to a predetermined position.
Fourth step: before the balloon 10 is expanded, contrast fluid is infused into the left ventricle through the contrast segment 31 of the functional tube 30 on the valve balloon dilation catheter 300 to see if the left ventricle and mitral valve are working properly.
Fifth step: the balloon 10 is inflated, the balloon expandable valve prosthesis 200 is expanded, and then the pressure is rapidly released, securing the balloon expandable valve prosthesis 200 in place in the aortic valve annulus.
Sixth step: contrast fluid is infused into the left ventricle through the contrast segment 31 of the functional tube 30 to observe and determine whether the implanted balloon expandable valve prosthesis 200 affects the mitral valve structure and observe the regurgitation condition of the mitral valve, to evaluate the effectiveness of the TAVI procedure and determine whether further therapeutic action is needed.
The foregoing has outlined rather broadly the more detailed description of embodiments of the invention, wherein the principles and embodiments of the invention are explained in detail using specific examples, the above examples being provided solely to facilitate the understanding of the method and core concepts of the invention; meanwhile, as those skilled in the art will have variations in the specific embodiments and application scope in accordance with the ideas of the present invention, the present description should not be construed as limiting the present invention in view of the above.
Claims (12)
1. A valve balloon dilation catheter, which is characterized by comprising a balloon, a catheter and a functional tube; the catheter has a first guidewire lumen and a first guidewire lumen; the catheter is in sealing connection with the proximal end of the balloon; the functional tube comprises a radiography section and a flexible supporting section connected with the distal end of the radiography section, the proximal end of the radiography section is connected with the distal end of the balloon in a sealing way, the radiography section is provided with a radiography hole exposing the balloon, and the radiography hole is communicated with the first radiography cavity; the flexible support section is provided with a second guide wire cavity which penetrates from the proximal end to the distal end of the flexible support section and is communicated with the first guide wire cavity, and the flexible support section is in a winding state in a natural state;
the catheter comprises an inner pipe and an outer pipe sleeved outside the inner pipe and radially arranged at intervals with the inner pipe; the proximal end of the balloon is in sealing connection with the outer tube, and a balloon filling cavity communicated with the interior of the balloon is formed between the inner tube and the outer tube; the inner tube is axially penetrated and provided with the first guide wire cavity and the first imaging cavity which is radially arranged at intervals with the first guide wire cavity and is communicated with the imaging hole;
the contrast section is provided with a first limiting cavity communicated with the second guide wire cavity along the axial direction, the inner tube is embedded in the first limiting cavity in a sealing way, and the first guide wire cavity is in butt joint with the second guide wire cavity in a sealing way;
the inner tube comprises a main body section and an extension section extending out of the distal end of the main body section, and the outer diameter of the main body section is larger than that of the extension section; the first guidewire lumen extends through the main body segment and the extension segment, and the first contrast lumen extends through the main body segment; the contrast section is axially provided with a second limiting cavity communicated with the first limiting cavity, the far end of the main body section is embedded in the near end of the first limiting cavity in a sealing mode, and the extension section is embedded in the second limiting cavity in a sealing mode.
2. The valve balloon dilation catheter of claim 1 wherein in said natural state, a distal end of said flexible support segment is wrapped at least one turn, said flexible support segment being pigtail-shaped.
3. The valve balloon dilation catheter of claim 1 wherein said flexible support section is made of a flexible material having a shore hardness in the range of 60A-90A.
4. The valve balloon dilation catheter of claim 3 wherein said flexible material having elasticity comprises at least one of a block polyether amide, a thermoplastic polyurethane elastomer rubber.
5. The valve balloon dilation catheter of claim 1 wherein an outer diameter of said flexible support segment tapers from a proximal end to a distal end of said flexible support segment, said distal end of said flexible support segment being provided with a tapered transition head.
6. The valve balloon dilation catheter of claim 1 wherein said extension section cooperates with a distal end of said main body section and said contrast section to define a second contrast lumen in communication with said first contrast lumen and said contrast aperture.
7. The valve balloon dilation catheter of claim 1 wherein a distal end of the body section is correspondingly located at a junction of the contrast section and a distal end of the balloon, the extension section being exposed at the contrast aperture.
8. The valve balloon dilation catheter of claim 1, wherein said first spacing lumen and said second spacing lumen are coaxially disposed and are stepped, a radial dimension of said first spacing lumen being greater than a radial dimension of said second spacing lumen.
9. The valve balloon dilation catheter of claim 1 wherein said contrast segment comprises a straight segment and first and second tapered heads disposed at opposite ends of said straight segment, said second tapered head being connected to said flexible support segment, said first spacing lumen extending axially through said first tapered head and said straight segment, said second spacing lumen being disposed within said second tapered head, a distal end of said extension segment abutting a proximal end of said flexible support segment.
10. The valve balloon dilation catheter of claim 1 wherein said first guidewire lumen extends along a central axis of said inner tube, said first contrast lumen extends parallel to said central axis of said inner tube, and said first contrast lumen is circumferentially disposed about said first guidewire lumen.
11. The valve balloon dilation catheter of claim 1 wherein the number of said visualization holes and said first visualization lumens comprises one or more, a plurality of said visualization holes being disposed in a uniform arrangement along a circumference of said visualization section, a plurality of said first visualization lumens being disposed in a uniform arrangement along a circumference of said first guidewire lumen.
12. A valve replacement system comprising a guidewire, a balloon-expandable valve prosthesis, and the valve balloon dilation catheter of any one of claims 1-11, the balloon-expandable valve prosthesis being mounted on the balloon in a radially compressed state; in the working state, the first guide wire cavity and the second guide wire cavity are sleeved on the guide wire.
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