CN114309974A - Hypotube and interventional catheter with same - Google Patents
Hypotube and interventional catheter with same Download PDFInfo
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- CN114309974A CN114309974A CN202111519702.7A CN202111519702A CN114309974A CN 114309974 A CN114309974 A CN 114309974A CN 202111519702 A CN202111519702 A CN 202111519702A CN 114309974 A CN114309974 A CN 114309974A
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- cutting
- hypotube
- groove
- cutting area
- distal
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- 238000005520 cutting process Methods 0.000 claims abstract description 100
- 238000003698 laser cutting Methods 0.000 claims abstract description 9
- 238000010276 construction Methods 0.000 claims description 2
- 230000007704 transition Effects 0.000 abstract description 5
- 238000005516 engineering process Methods 0.000 abstract description 3
- 230000008093 supporting effect Effects 0.000 abstract 1
- 239000000463 material Substances 0.000 description 6
- 239000004952 Polyamide Substances 0.000 description 4
- 229910000831 Steel Inorganic materials 0.000 description 4
- 229920009441 perflouroethylene propylene Polymers 0.000 description 4
- 229920002647 polyamide Polymers 0.000 description 4
- 239000004810 polytetrafluoroethylene Substances 0.000 description 4
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 4
- 239000010959 steel Substances 0.000 description 4
- 239000010963 304 stainless steel Substances 0.000 description 2
- 239000004812 Fluorinated ethylene propylene Substances 0.000 description 2
- 239000004698 Polyethylene Substances 0.000 description 2
- 229910000589 SAE 304 stainless steel Inorganic materials 0.000 description 2
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 2
- 239000010931 gold Substances 0.000 description 2
- 229910052737 gold Inorganic materials 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- -1 polyethylene Polymers 0.000 description 2
- 229920000573 polyethylene Polymers 0.000 description 2
- 229920000098 polyolefin Polymers 0.000 description 2
- 229920002635 polyurethane Polymers 0.000 description 2
- 239000004814 polyurethane Substances 0.000 description 2
- 229920000915 polyvinyl chloride Polymers 0.000 description 2
- 239000004800 polyvinyl chloride Substances 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- WFKWXMTUELFFGS-UHFFFAOYSA-N tungsten Chemical compound [W] WFKWXMTUELFFGS-UHFFFAOYSA-N 0.000 description 2
- 239000010937 tungsten Substances 0.000 description 2
- 229910052721 tungsten Inorganic materials 0.000 description 2
- 229910000619 316 stainless steel Inorganic materials 0.000 description 1
- 241001474374 Blennius Species 0.000 description 1
- 229910000566 Platinum-iridium alloy Inorganic materials 0.000 description 1
- 229910002835 Pt–Ir Inorganic materials 0.000 description 1
- WAIPAZQMEIHHTJ-UHFFFAOYSA-N [Cr].[Co] Chemical class [Cr].[Co] WAIPAZQMEIHHTJ-UHFFFAOYSA-N 0.000 description 1
- 229910045601 alloy Inorganic materials 0.000 description 1
- 239000000956 alloy Substances 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 229910001000 nickel titanium Inorganic materials 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- HWLDNSXPUQTBOD-UHFFFAOYSA-N platinum-iridium alloy Chemical class [Ir].[Pt] HWLDNSXPUQTBOD-UHFFFAOYSA-N 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
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Abstract
The invention relates to the technical field of medical instruments, in particular to a hypotube and an interventional catheter with the hypotube, wherein the hypotube comprises a main body of a tubular hollow structure, and the main body is provided with a proximal end face, a distal end face and a lateral periphery face positioned between the proximal end face and the distal end face; the lateral periphery comprises a non-cutting area and a cutting area, a cutting groove is formed in the cutting area through laser cutting, and the non-cutting area comprises a near-end non-cutting area and a far-end non-cutting area. According to the technical scheme, the cutting area of the hypotube is subjected to laser cutting through a laser cutting technology to obtain the hypotube in a specific cutting form, and the requirements of different areas of the interventional catheter on the supporting property and the flexibility and the smooth transition of the flexibility of the pipe are met by controlling the angle of the cutting groove, the radian of the cutting groove, the width of the cut of the cutting groove, the radian ratio of the cutting groove to the uncut groove and the like.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a hypotube and an interventional catheter with the hypotube.
Background
The interventional catheter of the medical apparatus has strict requirements on the performance of the interventional catheter, especially the support and flexibility of the interventional catheter, because the interventional catheter needs to enter the body during the use process.
The current interventional catheters usually comprise three layers of structures, namely an inner layer, a steel wire braided layer and an outer layer, wherein the inner layer needs to be matched with other instruments for use, and the other instruments have good trafficability; the outer layer is in contact with the tissues in the body, and needs to have good lubricity so as to reduce the intervention resistance; the steel braid, between the inner and outer layers, needs to provide sufficient support and good compliance to allow passage of tortuous lines. The current interventional catheter is usually segmented into a whole catheter, a proximal section is a steel wire braided layer with the same braided structure, and a distal section is free of the steel wire braided layer to meet the requirement of the interventional catheter on flexibility in the interventional process. However, in practical application, the structure and the processing technology are easy to cause the problems of unstable transition of the segmented structure, easy fracture between segments, insufficient support performance of the far-end segment and complex processing.
Disclosure of Invention
The invention aims to overcome the technical problems and provide a hypotube which has flexibility and support.
The invention adopts the following technical scheme:
a hypotube comprising a body of tubular hollow construction having a proximal face, a distal face and a lateral periphery between the proximal and distal faces; the lateral periphery comprises a non-cutting area and a cutting area, a cutting groove is formed in the cutting area through laser cutting, and the non-cutting area comprises a near-end non-cutting area and a far-end non-cutting area.
According to the technical scheme, the cutting area of the hypotube is subjected to laser cutting through a laser cutting technology, so that the hypotube with a specific cutting form is obtained, wherein the requirements of different areas of the interventional catheter on the support property and the flexibility and the smooth transition of the flexibility of the tube are met by controlling the angle of the cutting groove, the radian of the cutting groove, the width of the cut of the cutting groove, the radian ratio of the cutting groove to the uncut groove and the like.
The material of the hypotube is not particularly limited, and the material of the hypotube can be 304 stainless steel, 316 stainless steel, nickel-titanium alloy, cobalt-chromium alloy and the like.
Preferably, on the cutting area, the cutting grooves are arranged along the circumferential direction of the pipe at a certain cutting angle, and the angle of the cutting grooves is alpha and is in the range of 80 degrees to alpha < 90 degrees.
Preferably, the body has a plurality of the cutting grooves on the same circumferential surface, non-cutting grooves are formed between adjacent cutting grooves, and the radian of the cutting groove + the radian of the non-cutting groove = a specific value, which cannot be divided by 360; the radian of the cutting groove and the radian of the uncut groove are the radians of the vertical projection sections of the cutting groove and the uncut groove on the end surface of the pipe.
Preferably, the specific value ranges from 50 ° to 300 °.
Preferably, a ratio of the curvature of the cut groove to the curvature of the non-cut groove is 1 or more.
Preferably, the angle of the cutting groove increases gradually from the proximal end to the distal end of the body.
Preferably, the cutting area is segmented according to different cutting groove angles, and the number n of the segments is more than or equal to 2.
Preferably, the angles of the cutting grooves of different sections are gradually increased from the proximal end to the distal end, and the angle difference beta is in the range of 0 degrees to beta less than or equal to 5 degrees.
Preferably, the length of the most distal section of the cutting area is more than or equal to 30 mm.
Preferably, the length of the near-end non-cutting area is 5-30 mm, and the length of the far-end non-cutting area is 0.2-1.0 mm.
Preferably, the width of the cut of the cutting groove is 0.01-0.1 mm.
Preferably, the body inner diameter ID: 1.0 mm-5.0 mm; outer diameter OD: 1.10 mm-5.30 mm; length L: 0.2m to 3.0 m.
The invention also provides an interventional catheter which comprises the hypotube.
Furthermore, the interventional catheter comprises an inner tube, a developing ring arranged at the far end of the inner tube, the hypotube sleeved outside the inner tube, an outer tube sleeved outside the hypotube and the developing ring, and a heat-shrinkable tube sleeved outside the outer tube.
Preferably, the distance between the hypotube and the developing environment is kept at a certain distance, and the distance is 1-20 mm.
Preferably, the developing ring is made of platinum-iridium alloy, gold and tungsten, and has a width of 1-3 mm.
Preferably, the inner tube and the outer tube are made of the same material, and the material is polyamide, modified polyamide, polyurethane, polyethylene, polyvinyl chloride, FEP, or PTFE.
Preferably, the heat shrinkable tube is a tearable heat shrinkable tube, and is made of FEP, polyolefin, and PTFE.
Through the implementation of the technical scheme, compared with the prior art, the invention has the following advantages:
according to the invention, the cutting area of the hypotube is subjected to laser cutting, and the requirements of different areas of the interventional catheter on the support property and the flexibility and the gentle transition of the flexibility of the tubing are realized by controlling the angle of the cutting groove, the radian of the cutting groove, the width of the cut of the cutting groove, the radian ratio of the cutting groove to the uncut groove and the like.
Drawings
FIG. 1 is a schematic plan view of a hypotube according to one embodiment of the present invention;
FIG. 2 is a partially enlarged schematic view of a hypotube according to one embodiment of the present invention;
FIG. 3 is a schematic view of an interventional catheter in accordance with an embodiment of the present invention;
fig. 4 is a schematic cross-sectional view of fig. 3.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments of the present invention, are within the scope of the present invention.
Furthermore, the following description of the various embodiments refers to the accompanying drawings, which illustrate specific embodiments in which the invention may be practiced. Directional phrases used in this disclosure, such as, for example, "upper," "lower," "front," "rear," "left," "right," "inner," "outer," "side," and the like, refer only to the orientation of the appended drawings and are, therefore, used herein for better and clearer illustration and understanding of the invention, and do not indicate or imply that the device or element so referred to must have a particular orientation, be constructed and operated in a particular orientation, and are therefore not to be considered limiting of the invention.
The present invention will be described in detail below with reference to the drawings and examples. The terms "proximal", "distal" and "axial" are used herein as terms customary in the field of interventional medicine. Specifically, "distal" refers to the end of the surgical procedure that is distal to the operator; "proximal" means the end near the operator during a surgical procedure; "axial" refers to the direction of the central axis of the device, and the radial direction is perpendicular to the central axis.
Example 1:
a hypotube is made of 304 stainless steel, and the main body of the hypotube is a hollow metal thin-wall tube which is integrally seen and is provided with a near end surface, a far end surface and a lateral peripheral surface between the near end surface and the far end surface. The main body specifications are generally as follows: inner diameter ID: 1.0 mm-5.0 mm; outer diameter OD: 1.10 mm-5.30 mm; length L: 0.2m to 3.0 m. In this embodiment, the inner diameter ID: 2.00 mm; outer diameter OD: 2.15 mm; length L: 1m, and a solvent.
In order to ensure that the hypotube has both the pushing performance and the flexibility after being implanted into a blood vessel, and ensure better clinical use effect. The invention realizes the requirements of the interventional catheter on the support and flexibility and the gentle transition of the flexibility by controlling the angle of the cutting groove, the radian of the cutting groove, the incision width of the cutting groove, the radian ratio of the cutting groove to the uncut groove and the like.
In one embodiment, as shown in fig. 1, the lateral periphery is divided into a non-cutting area near the proximal end surface and the distal end surface and a cutting area 01 between the two non-cutting areas, wherein the non-cutting areas comprise a proximal non-cutting area 02 and a distal non-cutting area 03, and the length of the proximal non-cutting area 02 is 5-30 mm, preferably 20 mm. The length of the far-end non-cutting area 03 is 0.2-1.0 mm, and preferably 1.0 mm.
As shown in the attached figure 2, a cutting groove 04 is formed on the cutting area by laser cutting, the angle of the cutting groove 04 is alpha, the range is more than or equal to 80 degrees and less than 90 degrees, the width of the cut of the cutting groove is 0.01-0.1 mm, and the preferable width is 0.05 mm; on the same circumference, a plurality of cutting grooves are formed by cutting, non-cutting grooves are formed between adjacent cutting grooves, the sum of the radian of each cutting groove and the radian of each non-cutting groove is a specific value, the specific value cannot be divided by 360 in an integer mode, and the specific value ranges from 50 degrees to 300 degrees. And segmenting the cutting area according to different angles of the cutting grooves, wherein the number n of the segments is more than or equal to 2. And the angles of the cutting grooves at different sections need to be gradually increased from the near end to the far end, and the angle difference beta ranges from 0 degree to beta less than or equal to 5 degrees.
In this embodiment, the number n of segments of the cutting region of the hypotube is 4, and a total of six segments (refer to fig. 1, sequentially a to F) are counted for the proximal non-cutting region 02 and the distal non-cutting region 03, the lengths of the cutting region from the proximal end to the distal end are 800mm, 80mm, 60mm and 39mm, and the angles of the cutting grooves of the segments are 80 °, 83 °, 86 ° and 88 °, respectively. The radian of the cutting groove is 120 degrees, and the radian of the uncut groove is 30 degrees.
Example 2:
an interventional catheter, as shown in fig. 3-4, comprises a catheter holder 05 and a catheter main body connected with the catheter holder, wherein the catheter main body comprises an inner tube 08, a developing ring 06 arranged at the distal end of the inner tube, a hypotube 09 sleeved outside the inner tube, an outer tube 10 sleeved outside the hypotube and the developing ring, and a heat-shrinkable tube 11 sleeved outside the outer tube. The hypotube used in example 1 was a hypotube. In one embodiment, the inner tube and the outer tube are made of the same material, and the material is polyamide, modified polyamide, polyurethane, polyethylene, polyvinyl chloride, FEP, or PTFE.
In one embodiment, the developing ring is made of Pt-Ir alloy, gold or tungsten, and has a width of 1-3 mm.
In one embodiment, the heat shrinkable tube is a tearable heat shrinkable tube made of FEP, polyolefin or PTFE.
In the manufacturing process of the interventional catheter, an inner tube is sleeved on a mandrel by means of a mandrel, and a developing ring is sleeved on the far end of the inner tube. And then, sleeving the laser-cut seaweed pipe on the inner pipe, and keeping a certain distance, generally 1-20 mm, preferably 20mm, with the developing ring. Then, the outer tube is sleeved outside the hypotube and the developing ring, so that the outer tube completely covers the inner tube and the developing ring. And sleeving a heat-shrinkable tube outside the outer tube to completely cover the outer tube. Then, the inner tube and the outer tube are melted by heating, and the hypotube and the development ring are wrapped together. And tearing off the heat-shrinkable tube, pulling out the mandrel, and cutting the pipe to ensure that the distance between the far end of the developing ring and the far end of the interventional catheter is 1-5 mm. And finally, carrying out tip molding on the distal end of the catheter, namely finishing the processing of the interventional catheter.
Claims (10)
1. A hypotube comprising a body of tubular hollow construction having a proximal face, a distal face and a lateral periphery between the proximal and distal faces; the side circumferential surface comprises a non-cutting area and a cutting area, a cutting groove is formed in the cutting area through laser cutting, and the non-cutting area comprises a near-end non-cutting area and a far-end non-cutting area.
2. The hypotube of claim 1, wherein the cutting zones have cutting grooves arranged at a cutting angle along the circumference of the tubing, the cutting grooves having an angle α in the range of 80 ° to 90 °.
3. The hypotube of claim 1, wherein the angle of the cutting slots increases progressively from the proximal end to the distal end of the body.
4. The hypotube of claim 1, wherein the cutting zone is segmented according to the angle of the cutting slots, the number n of segments is greater than or equal to 2, the angles of the cutting slots of different segments increase gradually from the proximal end to the distal end of the body, and the angle difference β ranges from 0 ° < β ≦ 5 °.
5. A hypotube according to claim 4, wherein the distal most section of the cutting zone is greater than or equal to 30mm in length.
6. The hypotube of claim 1, wherein the proximal uncut region has a length of 5-30 mm and the distal uncut region has a length of 0.2-1.0 mm.
7. The hypotube of claim 1, wherein the body has a plurality of said cuts on a same circumferential surface, and non-cuts are formed between adjacent cuts.
8. A hypotube according to claim 7, wherein the arc of the cutting slot is: the radian of the non-cutting groove is more than or equal to 1.
9. The hypotube of claim 1, wherein the cut width of the cut groove is 0.01-0.1 mm.
10. An interventional catheter comprising a hypotube according to any one of claims 1-9.
Priority Applications (1)
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CN202111519702.7A CN114309974A (en) | 2021-12-14 | 2021-12-14 | Hypotube and interventional catheter with same |
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CN202111519702.7A CN114309974A (en) | 2021-12-14 | 2021-12-14 | Hypotube and interventional catheter with same |
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Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20120184982A1 (en) * | 2011-01-19 | 2012-07-19 | Endologix, Inc. | Methods and Systems for Treating Aneurysms |
CN106963992A (en) * | 2017-03-22 | 2017-07-21 | 尚华 | A kind of marmem hypotube and its application in blood vessel optical fiber seal wire |
CN211534995U (en) * | 2019-12-25 | 2020-09-22 | 上海微创医疗器械(集团)有限公司 | Plug protection device |
CN112023230A (en) * | 2020-09-17 | 2020-12-04 | 北京市凯泽斯商贸有限公司 | Pulmonary artery balloon dilatation catheter |
CN214966146U (en) * | 2021-02-20 | 2021-12-03 | 聚辉医疗科技(深圳)有限公司 | Delivery device and embolic coil system |
CN216858626U (en) * | 2021-12-14 | 2022-07-01 | 浙江巴泰医疗科技有限公司 | Hypotube and intervention pipe that has this hypotube |
-
2021
- 2021-12-14 CN CN202111519702.7A patent/CN114309974A/en active Pending
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20120184982A1 (en) * | 2011-01-19 | 2012-07-19 | Endologix, Inc. | Methods and Systems for Treating Aneurysms |
CN106963992A (en) * | 2017-03-22 | 2017-07-21 | 尚华 | A kind of marmem hypotube and its application in blood vessel optical fiber seal wire |
CN211534995U (en) * | 2019-12-25 | 2020-09-22 | 上海微创医疗器械(集团)有限公司 | Plug protection device |
CN112023230A (en) * | 2020-09-17 | 2020-12-04 | 北京市凯泽斯商贸有限公司 | Pulmonary artery balloon dilatation catheter |
CN214966146U (en) * | 2021-02-20 | 2021-12-03 | 聚辉医疗科技(深圳)有限公司 | Delivery device and embolic coil system |
CN216858626U (en) * | 2021-12-14 | 2022-07-01 | 浙江巴泰医疗科技有限公司 | Hypotube and intervention pipe that has this hypotube |
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