CN115738039A - Balloon catheter inner cavity structure, manufacturing method and tool thereof and balloon catheter - Google Patents
Balloon catheter inner cavity structure, manufacturing method and tool thereof and balloon catheter Download PDFInfo
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- CN115738039A CN115738039A CN202211549044.0A CN202211549044A CN115738039A CN 115738039 A CN115738039 A CN 115738039A CN 202211549044 A CN202211549044 A CN 202211549044A CN 115738039 A CN115738039 A CN 115738039A
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- 238000001125 extrusion Methods 0.000 claims abstract description 53
- 238000007731 hot pressing Methods 0.000 claims description 43
- 229920002614 Polyether block amide Polymers 0.000 claims description 8
- 239000011347 resin Substances 0.000 claims description 6
- 229920005989 resin Polymers 0.000 claims description 6
- 238000000034 method Methods 0.000 claims description 5
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims description 5
- 239000004810 polytetrafluoroethylene Substances 0.000 claims description 5
- 229910001220 stainless steel Inorganic materials 0.000 claims description 4
- 239000004677 Nylon Substances 0.000 claims description 3
- 229920001778 nylon Polymers 0.000 claims description 3
- -1 polytetrafluoroethylene Polymers 0.000 claims description 3
- 210000004204 blood vessel Anatomy 0.000 abstract description 10
- 238000010438 heat treatment Methods 0.000 description 17
- 238000009792 diffusion process Methods 0.000 description 12
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- 208000007536 Thrombosis Diseases 0.000 description 5
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- 238000003825 pressing Methods 0.000 description 4
- 230000008859 change Effects 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 210000005077 saccule Anatomy 0.000 description 3
- 229910001369 Brass Inorganic materials 0.000 description 2
- 230000009471 action Effects 0.000 description 2
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- 238000012986 modification Methods 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- 238000007493 shaping process Methods 0.000 description 2
- 229910000566 Platinum-iridium alloy Inorganic materials 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
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- 230000006837 decompression Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 238000002059 diagnostic imaging Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
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- 238000005485 electric heating Methods 0.000 description 1
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- 229920000126 latex Polymers 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
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- 238000012544 monitoring process Methods 0.000 description 1
- 230000036285 pathological change Effects 0.000 description 1
- 231100000915 pathological change Toxicity 0.000 description 1
- HWLDNSXPUQTBOD-UHFFFAOYSA-N platinum-iridium alloy Chemical class [Ir].[Pt] HWLDNSXPUQTBOD-UHFFFAOYSA-N 0.000 description 1
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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
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29D—PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
- B29D23/00—Producing tubular articles
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Abstract
The invention provides a balloon catheter inner cavity structure, a manufacturing method and a manufacturing tool thereof and a balloon catheter. Sacculus pipe inner chamber structure includes outer tube and interior sleeve pipe, the inner wall of outer tube encloses with interior sheathed tube outer wall and closes and form sufficient lumen, interior sheathed tube inner chamber forms the apparatus lumen, and the part of outer tube is through local outer expanding after the extrusion, form protruding sufficient lumen, the local enlargement of sufficient lumen has been realized, when being applied to sacculus pipe, can make the sacculus sufficient more rapidly, clinical operation is comparatively simple, the efficiency of clinical operation has been improved, also can make sacculus pressure release more rapidly simultaneously, the risk that has reduced the pressure release difficulty takes place, the security of clinical operation has been increased. Because the local expansion of filling the lumen is formed through extrusion, the whole hardness of the extrusion part is increased, the propelling performance is better, the balloon catheter can reach the target blood vessel position more smoothly, and the risk of poor instrument trafficability caused by reducing the instrument lumen can be avoided.
Description
Technical Field
The invention belongs to the technical field of balloon catheters, and particularly relates to a balloon catheter inner cavity structure, a manufacturing method and a manufacturing tool thereof, and a balloon catheter.
Background
In interventional diagnosis and treatment processes, protecting the far end of a blood vessel is an important subject in current interventional medicine, and the appearance of various balloon catheters provides more solutions for clinical interventional operations, for example, when the balloon catheter is used for plugging, under the monitoring of advanced medical imaging equipment, an arterial sheath is placed through percutaneous puncture, an auxiliary thrombus taking device reaches the near end of thrombus of the blood vessel, the balloon is expanded to be attached to the blood vessel wall to form local plugging, the thrombus taking device and the thrombus are adsorbed into the inner cavity of the catheter under the action of external negative pressure, then the balloon guide catheter is retracted through the contraction of the balloon, and the thrombus is taken out of a human body to achieve the purpose of blood flow reconstruction. Thus, the inflation and pressure release properties of many balloons with balloon catheters are particularly important, especially for dual lumen balloon catheters.
The existing double-cavity balloon catheter is designed as a double-cavity catheter body, the double-cavity catheter body comprises an instrument lumen and a filling lumen, the instrument enters a target blood vessel pathological change position through the instrument lumen, and the filling lumen serves as a filling balloon channel to achieve the purpose of filling and discharging the balloon. Because two-chamber sacculus pipe had both guaranteed in the design that the apparatus lumen has sufficient space so that pass through the apparatus, had to guarantee simultaneously that sufficient lumen can effectively satisfy the requirement of leaking of sacculus, so compare single chamber sacculus pipe, two-chamber sacculus pipe sufficient chamber is less, and is higher to filling the pressure release operation requirement, has the circumstances of filling slowly, pressure release difficulty, and clinical operation is more loaded down with trivial details.
Therefore, there is a need to provide an improved solution to the above-mentioned deficiencies of the prior art.
Disclosure of Invention
The invention aims to provide a balloon catheter inner cavity structure, a manufacturing method, a manufacturing tool and a balloon catheter, and aims to solve the problems that an existing double-cavity balloon catheter is small in filling cavity, high in requirement on filling and pressure relief operation, slow in filling and difficult in pressure relief, and complicated in clinical operation.
In order to achieve the above purpose, the invention provides the following technical scheme:
the inner cavity structure of the balloon catheter comprises an outer sleeve and an inner sleeve, wherein the outer sleeve is sleeved on the outer side of the inner sleeve, the inner wall of the outer sleeve and the outer wall of the inner sleeve enclose to form a filling lumen, and the inner cavity of the inner sleeve forms an instrument lumen;
the outer sleeve part is locally expanded after being extruded to form a bulge filling tube cavity.
In an alternative embodiment of the present invention, the extruded portion of the outer sleeve has a first viewing angle and a second viewing angle perpendicular to each other, the first viewing angle being such that the outer sleeve expands to form the convex filling lumen, and the second viewing angle being such that the outer sleeve is recessed and interferes with the inner sleeve to form the closed filling lumen.
In an alternative embodiment of the invention, the length of the extruded portion of the outer sleeve is 8-10mm.
In an optional embodiment of the invention, the outer sleeve is made of block polyether amide resin or nylon, the inner diameter of the outer sleeve is 2.55-2.65mm, and the wall thickness is 0.06-0.15mm;
the inner sleeve is a braided tube with a three-layer structure and sequentially comprises a polytetrafluoroethylene layer, a stainless steel wire braided layer and a block polyether amide resin layer from inside to outside, the inner diameter of the inner sleeve is 1.00-2.20mm, and the wall thickness is 0.2-0.5mm.
The invention also provides a manufacturing method of the balloon catheter inner cavity structure, which comprises the following steps:
step one, providing an outer sleeve and an inner sleeve;
and secondly, extruding the distal part of the outer sleeve to ensure that the distal part of the outer sleeve is locally expanded to form a bulge filling lumen.
In an optional embodiment of the invention, in the second step, the extrusion treatment is a hot pressing treatment, and the temperature of the hot pressing treatment is 200-300 ℃.
The invention also provides a manufacturing tool of the balloon catheter inner cavity structure, which comprises an extrusion assembly, wherein the extrusion assembly comprises two extrusion parts capable of moving relatively, and the two extrusion parts move relatively and contact with each other to form an extrusion cavity for extruding the outer sleeve part.
In an alternative embodiment of the present invention, the extrusion chamber comprises:
the cross section of the extrusion area is square and is used for extruding the part of the outer sleeve;
expand the region outward, set up to two expand the region outward and be located respectively the regional both sides of extrusion, and communicate in the extrusion region, expand the region outward and be used for the protruding full lumen that forms after the extrusion of holding outer tube.
The present invention also provides a balloon catheter, comprising: the balloon catheter inner cavity structure and the balloon are as described above, the balloon is arranged on the periphery of the outer sleeve, and the part of the outer sleeve covered by the balloon is provided with the filling hole which is communicated with the filling lumen of the balloon catheter inner cavity structure and the inside of the balloon.
In an alternative embodiment of the invention, the distance between the proximal end of the balloon and the distal end of the extruded portion of the outer sleeve is 4-6mm.
Has the beneficial effects that:
the inner cavity structure of the balloon catheter comprises an outer sleeve and an inner sleeve which are sleeved with each other, the inner wall of the outer sleeve and the outer wall of the inner sleeve are enclosed to form a filling lumen, the inner cavity of the inner sleeve forms an instrument lumen, and the outer sleeve is partially expanded after being extruded to form a convex filling lumen, so that the local expansion of the filling lumen is realized. Because the local expansion of the filling lumen is formed by extrusion, the overall hardness of the extrusion part is increased, so that the pushing performance is better, the balloon catheter can more smoothly reach the target blood vessel position, and the risk of poor instrument trafficability caused by reducing the instrument lumen can be avoided. In addition, a large amount of material cost and manual design and manufacturing cost brought by rapid filling and pressure relief of the balloon through raw material change are saved, labor and materials are saved, and a patient is benefited.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this specification, are included to provide a further understanding of the invention, and are included to illustrate an exemplary embodiment of the invention and not to limit the invention. Wherein:
FIG. 1 is a schematic view of a balloon catheter of the present invention in a first view;
FIG. 2 is a schematic view of a balloon catheter of the present invention from a second perspective;
FIG. 3 is an enlarged partial schematic view of the balloon catheter of FIG. 1;
FIG. 4 is an enlarged partial schematic view of the balloon catheter of FIG. 2;
FIG. 5 is an enlarged schematic view of the structure at A in FIG. 1;
FIG. 6 is an enlarged schematic view of the structure at B in FIG. 2;
FIG. 7 is a schematic sectional view of a partial structure of a manufacturing tool for a balloon catheter lumen structure in an open state according to the present invention;
fig. 8 is a schematic sectional view of a partial structure of the manufacturing tool of the balloon catheter inner cavity structure in a closed state.
Reference numbers in the figures: 1-a handle; 11-an instrument inlet; 12-filling liquid inlet; 2-outer stress diffusion tube; 3-inner stress diffusion tube; 4-outer sleeve; 41-filling lumen; 42-bulge filling lumen; 5-inner sleeve; 51-an instrument lumen; 6-filling the pores; 7-a balloon; 8-a developing ring; 9-hot-pressing; 91-hot pressing control block; 92-a heating block; 93-heat source transfer; 10-hot pressing cavity; 10 a-a hot pressing zone; 10 b-flaring region.
Detailed Description
The technical solutions in the embodiments of the present invention will be described clearly and completely below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived from the embodiments of the present invention by a person skilled in the art, are within the scope of the present invention.
The present invention will be described in detail with reference to examples. It should be noted that the embodiments and features of the embodiments may be combined with each other without conflict.
The invention provides an inner cavity structure of a balloon catheter, and aims to solve the problems that an existing double-cavity balloon catheter is small in filling cavity, high in requirements for pressure filling and releasing operation, slow in filling, difficult in pressure releasing and more complicated in clinical operation.
As shown in fig. 1 to 6, the balloon catheter inner cavity structure of the present invention includes an outer sleeve 4 and an inner sleeve 5, both the outer sleeve 4 and the inner sleeve 5 are circular tube structures, the outer sleeve 4 is sleeved on the outer side of the inner sleeve 5, the inner wall of the outer sleeve 4 and the outer wall of the inner sleeve 5 enclose to form a filling lumen 41, the filling lumen 41 serves as a passage of the filling balloon 7 to achieve the purpose of filling and discharging the balloon 7, the inner cavity of the inner sleeve 5 forms an instrument lumen 51, and the instrument lumen 51 is used for an instrument to pass through to enter a target vascular lesion position. Wherein, the part of outer tube 4 expands through local outside after the extrusion, forms protruding sufficient lumen 42, has realized promptly that the part of sufficient lumen 41 enlarges, when sacculus pipe inner chamber structure is applied to the sacculus pipe, can be so that sacculus 7 is sufficient more rapidly, and clinical operation is comparatively simple, has improved clinical operation's efficiency, also can make sacculus 7 pressure release more rapidly simultaneously, has reduced the risk of pressure release difficulty and has taken place, has increased clinical operation's security.
Because the local expansion of the filling lumen 41 is formed by extrusion, the overall hardness of the extruded part is increased, so that the pushing performance is better, the balloon catheter can reach the target blood vessel position more smoothly, and the risk of poor instrument trafficability caused by reducing the instrument lumen 51 can be avoided, the instrument lumen 51 of the invention still maintains a large enough trafficability space, so that the compatibility of the balloon catheter and other instruments is better, and the risk of poor adaptability of the balloon catheter and the target blood vessel caused by increasing the outer diameter of the outer sleeve 4 is also avoided, the outer diameter of the outer sleeve 4 of the invention still maintains a reasonable size, so that the balloon catheter and the target blood vessel maintain good adaptability. In addition, a large amount of material cost and manual design and manufacturing cost brought by rapid filling and pressure relief of the balloon 7 through raw material change are saved, labor and materials are saved, and a patient is benefited.
It should be noted that, since the local enlargement of the filling lumen 41 is formed by squeezing, that is, the squeezed portion of the overtube 4 has a first viewing angle (as shown in fig. 1, 3 and 5) and a second viewing angle (as shown in fig. 2, 4 and 6) perpendicular to each other, in the first viewing angle, the overtube 4 is expanded to form the convex filling lumen 42, and in the second viewing angle, the overtube 4 is concave.
Further, after extrudeing to the certain degree, under the second visual angle, outer tube 4 contradicts in interior sleeve pipe 5's outer wall, forms closed sufficient lumen 41, and support nature that 4 distal ends extrusion parts of outer tube have the preferred can be guaranteed in such design, and this extrusion part bulk hardness preferred, and the sufficient lumen 41 non-deformable of operation process of taking in clinical use and operation can keep original size for a long time sufficient passageway for clinical operation is more safety and stability.
In the embodiment of the invention, the length of the extrusion part of the outer sleeve 4 is 8-10mm (for example, 8m, 8.5m, 9m, 9.5m, 10m and the interval value between any two endpoint values), and the extrusion part with the length range is designed, so that the balloon 7 can be inflated and decompressed more quickly, and the integral hardness of the extrusion part can be ensured.
Optionally, the outer sleeve 4 is made of block polyether amide resin or nylon, which is convenient for the extrusion operation, and the outer sleeve 4 is also selected to have a suitable size to ensure the strength, and optionally, the outer sleeve 4 has an inner diameter of 2.55-2.65mm (such as 2.55mm, 2.58mm, 2.60mm, 2.62mm, 2.65mm, and any interval therebetween) and a wall thickness of 0.06-0.15mm (such as 0.06mm, 0.07mm, 0.08mm, 0.09mm, 0.10mm, 0.11mm, 0.12mm, 0.13mm, 0.14mm, 0.15mm, and any interval therebetween).
Optionally, the inner sleeve 5 is a braided tube with a three-layer structure, and sequentially comprises a Polytetrafluoroethylene (PTFE) layer, a stainless steel wire braid layer and a block polyether amide resin (PEBAX) layer from inside to outside, wherein the lining layer is made of PTFE, so that the inner sleeve has better lubricity and is beneficial to instruments to pass through; the structure of the stainless steel wire braid layer can ensure that the support performance of the inner sleeve 5 is excellent; the outer PEBAX layer can be designed by hardness gradual change, namely, the hardness is gradually reduced along the direction from the near end to the far end, so that the excellent support property of the near end can be met, and meanwhile, the better flexibility of the far end can be considered.
In a particular embodiment of the invention, the inner jacket tube 5 has an inner diameter of 1.00-2.20mm (e.g. 1.00mm, 1.20mm, 1.40mm, 1.60mm, 1.80mm, 2.00mm, 2.20mm and any interval therebetween) and a wall thickness of 0.20-0.50mm (e.g. 0.20mm, 0.30mm, 0.40mm, 0.50mm and any interval therebetween).
The invention also provides a manufacturing method of the balloon catheter inner cavity structure, which comprises the following steps:
step one, providing an outer sleeve 4 and an inner sleeve 5, namely providing the outer sleeve 4 and the inner sleeve 5 which are made of the materials and have the sizes.
And secondly, extruding the distal end part of the outer sleeve 4, so that the distal end part of the outer sleeve 4 is locally expanded to form a bulge filling lumen 42.
In the embodiment of the present invention, the extrusion treatment in the second step is a hot pressing treatment, the temperature of the hot pressing treatment is 200-300 ℃ (for example, 200 ℃, 210 ℃, 220 ℃, 230 ℃, 240 ℃, 250 ℃, 260 ℃, 270 ℃, 280 ℃, 290 ℃, 300 ℃) and the interval value between any two endpoint values), and the outer sleeve 4 can be effectively melted and extruded to be shaped by performing the extrusion treatment in the above temperature range.
It should be noted that, during the extrusion treatment, after the distal portion of the outer cannula 4 is partially extruded, at the first viewing angle, the distal portion is partially expanded to form the convex inflation lumen 42, and at the same time, the closed inflation lumen 41 is partially formed at the second viewing angle, which not only ensures that the distal extrusion portion of the outer cannula 4 has better support performance and the overall hardness of the extrusion portion is better, but also ensures that the inflation and pressure release of the balloon 7 are quicker.
The invention also provides a manufacturing tool of the balloon catheter inner cavity structure, which is used for manufacturing the balloon catheter inner cavity structure.
The manufacturing tool comprises an extrusion assembly, wherein the extrusion assembly comprises two extrusion parts capable of moving relatively, and an extrusion cavity is formed after the two extrusion parts move relatively and contact with each other and is used for extruding the outer sleeve part.
As shown in fig. 7 and 8, in the specific embodiment, the extrusion assembly is a hot-pressing assembly, the extrusion member is a hot-pressing member 9, the extrusion cavity is a hot-pressing cavity 10, and the manufacturing tool further includes a heating device, which is an existing heating device, may be an electric heating device, and is used for providing heat for the hot-pressing member 9; the hot pressing part 9 is connected to the heating device through the heat source transfer part 93, the heat source transfer part 93 is used for transferring heat of the heating device to the hot pressing part 9, and the heat source transfer part 93 and the hot pressing part 9 can be made of brass materials, so that the hot pressing part is high-temperature resistant, good in heat conductivity and not prone to deformation. Alternatively, the heat source transfer member 93 is shaped like a long rod, and both ends thereof are connected to the thermal compression member 9 and the heating device, respectively. The two heat pressing members 9 are moved relatively to each other to contact each other to form a heat pressing chamber 10 for heat pressing a portion of the outer sleeve 4.
Furthermore, the manufacturing tool further comprises a moving mechanism, the moving mechanism is in transmission connection with the hot pressing parts 9 and can drive and control the two hot pressing parts 9 to move relatively to contact or separate from each other, when a part of the outer sleeve 4 required to be subjected to hot pressing treatment is placed between the two hot pressing parts 9, the moving mechanism drives and controls the two hot pressing parts 9 to move relatively to contact, a hot pressing cavity 10 is formed, and the outer sleeve 4 located in the hot pressing cavity 10 is subjected to melting hot pressing and shaping under the action of heat.
It should be noted that the moving mechanism may be a moving cylinder, or may be another existing moving mechanism, and the moving mechanism is not limited herein as long as it can drive and control the two thermal pressing members 9 to move relatively to contact or separate from each other.
In the embodiment of the present invention, the hot pressing member 9 includes a hot pressing control block 91 and a heating block 92 connected to each other, the hot pressing control block 91 is connected to a moving mechanism, so that the moving mechanism can drive and control the hot pressing control block 91 and the heating block 92 to move together, the heating block 92 is located inside the hot pressing heating block 92, and the inner surface of the heating block 92 is a horizontal plane, the surface is recessed in the inner surface of the heating control block, a gap is provided between the two side surfaces of the heating block 92 and the hot pressing control block 91, when the hot pressing member 9 relatively moves to contact under the driving control of the moving mechanism, the formed hot pressing cavity 10 includes a hot pressing region 10a and an outward expansion region 10b, wherein the cross section of the hot pressing portion is square and is used for performing hot pressing on the distal end portion of the outer sleeve 4; the two externally expanding areas 10b are respectively arranged at two sides of the hot pressing area 10a and communicated with the hot pressing area 10a, and the externally expanding area 10b is used for accommodating a bulge filling lumen 42 formed after the outer sleeve 4 is hot pressed. Optionally, the edge of the flaring region 10b not connected with the hot pressing region 10a is a circular arc edge.
In the manufacturing process, the hot press control block 91 and the heating block 92 are integrated and made of brass, and the heat source transmission member 93 is disposed on the opposite side of the hot press member 9 and connected to the heating device.
When the inner cavity structure of the balloon catheter is manufactured, firstly, the heating device is started, when the temperature reaches the preset temperature (namely 200-300 ℃), the part to be processed at the far end of the outer sleeve 4 is placed between the two heating blocks 92 of the two hot pressing parts 9, then the moving mechanism is started, the two hot pressing parts 9 are driven and controlled to move relatively until being contacted to form an extrusion cavity, so that the far end part of the outer sleeve 4 is extruded and shaped, the bulge filling tube cavity 42 formed after extrusion shaping is contained in the outer expanding area 10b, at this moment, the moving mechanism is started again, the two hot pressing parts 9 are driven and controlled to move back to the original position in a split mode, and the operation is finished.
The invention also provides a balloon catheter which comprises the balloon catheter inner cavity structure.
As shown in fig. 1 to 4, the balloon catheter of the present invention further includes a balloon 7, the balloon 7 is disposed at the periphery of the distal end of the outer sheath 4, the portion of the outer sheath 4 covered by the balloon 7 is provided with a filling hole 6, the filling hole 6 communicates with the filling lumen 41 and the inside of the balloon 7, so that the filling liquid entering the filling lumen 41 from the filling liquid inlet 12 can enter the inside of the balloon 7 through the filling hole 6 to fill the balloon 7, and conversely, the filling liquid inside the balloon 7 can flow out through the filling hole 6 to enter the filling lumen 41 to relieve the pressure of the balloon 7.
It should be noted that reference herein to "distal" means the end distal to the operator and "proximal" means the end proximal to the operator.
The saccule 7 is made of super-compliance materials, the specific materials can be thermoplastic elastomers, silica gel or latex, the saccule 7 can be inflated under very small pressure, and the super-compliance materials can enable the saccule 7 to conform to any uneven and fragile blood vessels.
In the optional embodiment of the invention, the distance between the proximal end of the balloon 7 and the distal end of the extrusion part of the outer sleeve 4 is 4-6mm (for example, 4m, 4.5m, 5m, 5.5m, 6m and the interval value between any two endpoint values), so the balloon 7 can be filled more quickly and the clinical operation is simpler, the efficiency of the clinical operation is improved, meanwhile, the balloon 7 can be decompressed more quickly, the risk of difficult decompression is reduced, and the safety of the clinical operation is improved.
Further, the balloon catheter of the invention further comprises a handle 1, the handle 1 is connected with the proximal end of the outer sleeve 4 in the balloon catheter lumen structure, the handle 1 is of a Y-shaped structure and is provided with an inflation liquid inlet 12 and an instrument inlet 11, the inflation liquid inlet 12 is communicated with the inflation lumen 41 in the balloon catheter lumen structure and is used for conveying the inflation liquid, and the instrument inlet 11 is communicated with an instrument lumen 51 in the balloon catheter lumen structure and is used for allowing an instrument to pass through.
Further, the sacculus pipe still includes outer stress diffusion pipe 2 and inlayer stress diffusion pipe 3, the near-end and the handle 1 of outer stress diffusion pipe 2 are connected, the distal end of outer stress diffusion pipe 2 is connected with the near-end of inlayer stress diffusion pipe 3, specifically for cup jointing, the internal diameter of outer stress diffusion pipe 2 and the external diameter looks adaptation of inlayer stress diffusion pipe 3 promptly, the external diameter of outer tube 4 and the internal diameter looks adaptation of inlayer stress diffusion pipe 3, outer tube 4 overlaps in inlayer stress diffusion pipe 3, and be connected with the distal end of inlayer stress diffusion pipe 3, so design, can guarantee that the sacculus pipe has better bending resistance.
Furthermore, the distal end of the outer sleeve 4 is provided with a developing ring 8, the developing ring 8 is positioned on the far side of the balloon 7, the developing ring 8 is made of platinum-iridium alloy, and the developing ring has excellent developing performance, so that a doctor can control the operation process more accurately through a fluorescent device, and the safety of the operation is improved.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. The balloon catheter inner cavity structure is characterized by comprising an outer sleeve and an inner sleeve, wherein the outer sleeve is sleeved on the outer side of the inner sleeve, the inner wall of the outer sleeve and the outer wall of the inner sleeve are enclosed to form a filling tube cavity, and the inner cavity of the inner sleeve forms an instrument tube cavity;
the outer sleeve part is partially expanded after being extruded to form a bulge filling tube cavity.
2. A balloon catheter lumen structure according to claim 1, wherein the crushed portion of the outer sleeve has a first viewing angle and a second viewing angle perpendicular to each other, wherein in the first viewing angle the outer sleeve is expanded to form the convex filling lumen, and in the second viewing angle the outer sleeve is collapsed and abutted against the inner sleeve to form a closed filling lumen.
3. A balloon catheter lumen structure according to claim 1 wherein the length of the extruded portion of the outer sleeve is 8-10mm.
4. The balloon catheter lumen structure of claim 1, wherein the outer sleeve is made of block polyether amide resin or nylon, the inner diameter of the outer sleeve is 2.55-2.65mm, and the wall thickness is 0.06-0.15mm;
the inner sleeve is a braided tube with a three-layer structure and sequentially comprises a polytetrafluoroethylene layer, a stainless steel wire braid layer and a block polyether amide resin layer from inside to outside, the inner diameter of the inner sleeve is 1.00-2.20mm, and the wall thickness of the inner sleeve is 0.2-0.5mm.
5. A method for manufacturing the inner cavity structure of the balloon catheter according to any one of claims 1-4, wherein the manufacturing method comprises the following steps:
step one, providing an outer sleeve and an inner sleeve;
and step two, performing extrusion treatment on the distal part of the outer sleeve to ensure that the distal part of the outer sleeve is locally expanded to form a bulge filling lumen.
6. The method for manufacturing the inner cavity structure of the balloon catheter according to claim 5, wherein in the second step, the extrusion treatment is a hot pressing treatment, and the temperature of the hot pressing treatment is 200-300 ℃.
7. The tooling for manufacturing the inner cavity structure of the balloon catheter according to any one of claims 1 to 4, wherein the tooling comprises an extrusion assembly, the extrusion assembly comprises two extrusion parts capable of moving relatively, and the two extrusion parts form an extrusion cavity after moving relatively and contacting with each other, so that the extrusion cavity is used for extruding the outer sleeve part.
8. The manufacturing tool for the balloon catheter inner cavity structure according to claim 7, wherein the extrusion cavity comprises:
the cross section of the extrusion area is square and is used for extruding the part of the outer sleeve;
expand the region outward, set up to two expand the region outward and be located respectively the regional both sides of extrusion, and communicate in the extrusion region, expand the region outward and be used for the protruding sufficient lumen that forms after the extrusion of holding outer tube.
9. A balloon catheter, comprising:
the balloon catheter lumen structure of any one of claims 1-4;
the balloon is arranged on the periphery of the outer sleeve, a filling hole is formed in the part, covered by the balloon, of the outer sleeve, and the filling hole is communicated with a filling lumen of the balloon catheter inner cavity structure and the inside of the balloon.
10. A balloon catheter according to claim 9, wherein the distance between the proximal end of the balloon and the distal end of the extruded portion of the outer sleeve is 4-6mm.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211549044.0A CN115738039B (en) | 2022-12-05 | 2022-12-05 | Balloon catheter inner cavity structure, manufacturing method and manufacturing tool thereof and balloon catheter |
| PCT/CN2023/129587 WO2024074156A1 (en) | 2022-12-05 | 2023-11-03 | Balloon catheter inner cavity structure and manufacturing method and manufacturing tooling therefor, and balloon catheter |
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| CN202211549044.0A CN115738039B (en) | 2022-12-05 | 2022-12-05 | Balloon catheter inner cavity structure, manufacturing method and manufacturing tool thereof and balloon catheter |
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| CN115738039A true CN115738039A (en) | 2023-03-07 |
| CN115738039B CN115738039B (en) | 2023-06-16 |
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| CN202211549044.0A Active CN115738039B (en) | 2022-12-05 | 2022-12-05 | Balloon catheter inner cavity structure, manufacturing method and manufacturing tool thereof and balloon catheter |
Country Status (2)
| Country | Link |
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| CN (1) | CN115738039B (en) |
| WO (1) | WO2024074156A1 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2024074156A1 (en) * | 2022-12-05 | 2024-04-11 | 上海心玮医疗科技股份有限公司 | Balloon catheter inner cavity structure and manufacturing method and manufacturing tooling therefor, and balloon catheter |
| CN117959051A (en) * | 2024-01-17 | 2024-05-03 | 上海心玮医疗科技股份有限公司 | Radial artery access catheter |
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| WO2024074156A1 (en) * | 2022-12-05 | 2024-04-11 | 上海心玮医疗科技股份有限公司 | Balloon catheter inner cavity structure and manufacturing method and manufacturing tooling therefor, and balloon catheter |
| CN117959051A (en) * | 2024-01-17 | 2024-05-03 | 上海心玮医疗科技股份有限公司 | Radial artery access catheter |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2024074156A1 (en) | 2024-04-11 |
| CN115738039B (en) | 2023-06-16 |
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