KR101788491B1 - Balloon catheter - Google Patents
Balloon catheter Download PDFInfo
- Publication number
- KR101788491B1 KR101788491B1 KR1020167008548A KR20167008548A KR101788491B1 KR 101788491 B1 KR101788491 B1 KR 101788491B1 KR 1020167008548 A KR1020167008548 A KR 1020167008548A KR 20167008548 A KR20167008548 A KR 20167008548A KR 101788491 B1 KR101788491 B1 KR 101788491B1
- Authority
- KR
- South Korea
- Prior art keywords
- shaft
- distal end
- core wire
- rear end
- end shaft
- Prior art date
Links
Images
Classifications
-
- 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
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
- A61M25/0052—Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
-
- 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
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M2025/0183—Rapid exchange or monorail catheters
-
- 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
Abstract
The present invention relates to a method of manufacturing a core wire having a front end shaft 10 including a resin tube, a rear end shaft 20 including a metal tube, a balloon 30, an inner tube 40, And the core wire 50 including the straight portion 51 and the tapered portion 52 is fixed to the inner peripheral surface of the rear end shaft 20 on the rear end side of the straight portion 51 And is inserted between the inner peripheral surface of the distal end shaft 10 and the outer peripheral surface of the inner tube 40 at the distal end side of the straight portion 51. [ The balloon catheter having such a configuration is excellent in pushability when inserted into a blood vessel and can reliably prevent kinking in the rear end portion of the distal shaft, .
Description
The present invention relates to a rapid-exchange type balloon catheter.
BACKGROUND ART Conventionally, a balloon catheter having an outer shaft and an inner tube is known (see, for example, Patent Document 1 and Patent Document 2).
In a rapid-exchange type balloon catheter as shown in Patent Documents 1 and 2, a balloon is attached to the distal end of the outer shaft, the distal end of the inner tube is fixed to the distal end of the balloon, And is opened at the side surface to form a guide wire port.
On the other hand, a rear end shaft including a metal tube is connected to the rear end of the outer shaft including the resin tube.
Here, the lumen of the outer shaft (leading-end shaft) and the trailing-end shaft is an extension lumen through which the fluid for expanding the balloon flows, and the lumen of the inner tube is a guide wire lumen for inserting the guide wire.
In a balloon catheter of a rapid-exchange type as shown in Patent Documents 1 and 2, a core wire is inserted as a reinforcing member in a lumen of an outer shaft including a resin tube.
The rear end portion of the core wire is fixed to the inner circumferential surface of the rear end shaft including the metal tube by welding or the like. This makes it possible to improve the rigidity of the rear end portion of the outer shaft (front end shaft) that needs reinforcement, more specifically, the rear end portion of the guide wire port than the formation position thereof, The occurrence of the kink (buckling) of the belt can be suppressed to some extent.
Here, the core wire usually has a straight portion having a constant diameter and a tapered portion (diameter-reduced portion) located at the tip side of the straight portion. The tapered portion of the core wire is reduced in diameter in the tip direction, whereby the hardness (rigidity) of the balloon catheter can be gradually lowered toward the distal end.
However, in the balloon catheter as shown in Patent Documents 1 and 2, since the distal end portion of the core wire is not fixed to the inner circumferential surface of the outer shaft (the distal end is the free end portion), sufficient pushability can not be exhibited .
That is, when the balloon catheter is inserted into the blood vessel and the pressure input is applied from the rear end shaft, the core wire moves (advances) in the axial direction with respect to the outer shaft (distal end shaft) Can not be transmitted sufficiently.
In the balloon catheter in which the distal end of the core wire is not fixed on the inner circumferential surface of the outer shaft, when the balloon catheter is inserted into the blood vessel (when pressure is applied), the rear end portion (I.e., a portion up to the tip end position of the side shaft) can not be surely prevented.
With respect to such a problem, Patent Document 3 below discloses a balloon catheter comprising a core wire fixed to the inner circumferential surface of the outer shaft at the rear end portion of the outer shaft (distal shaft).
The core wire secured to the inner circumferential surface of the rear end shaft is also fixed to the inner circumferential surface of the distal end shaft so that the pressure input from the rear end shaft can be reliably transmitted to the distal end shaft as in the balloon catheter described in Patent Document 3, It can show pushability. Further, the stiffness of the shaft at the rear end side of the core wire can be made sufficiently higher than the fixing position of the core wire, and the kink at that portion can be reliably prevented.
However, when the core wire is firmly fixed to the inner circumferential surface of the distal end shaft as in the balloon catheter described in Patent Document 3, the bending rigidity of the distal end shaft becomes excessive, and flexibility is remarkably impaired. As a result, there arises a problem that such a balloon catheter can not be smoothly inserted into a bent blood vessel (for example, a blood vessel in the heart).
In the case where the fixing position of the core wire on the inner circumferential surface of the shaft on the distal end side is largely spaced from the formation position of the guide wire port to the rear end side, in the portion from the formation position of the guide wire port to the fixing position of the core wire It is not possible to sufficiently increase the rigidity of the portion, and there is a possibility that a kink occurs in the portion.
The present invention has been made on the basis of the above-described circumstances.
SUMMARY OF THE INVENTION An object of the present invention is to provide a kink (buckling) in a rear portion of a distal end shaft (a portion from a position where a guide wire port is formed to a distal end position of a rear end shaft) A balloon catheter of a rapid-exchange type that can be surely prevented and can be smoothly inserted into a curved blood vessel.
(1) A balloon catheter of the present invention comprises: a distal shaft provided with a resin tube;
A rear end shaft including a metal tube connected to a rear end of the front end shaft,
A balloon connected to a distal end of the distal shaft,
Wherein the balloon is inserted into the lumen of the distal end shaft and inside the balloon to form a guide wire lumen. The distal end of the resin tube is opened at the side of the distal end shaft as a guide wire port, An inner tube whose tip is opened,
And a core wire having a straight portion and a diameter reduction portion and having the diameter reduction portion as a distal end side and being inserted into a lumen of the distal end shaft,
The rear end side of the core wire is fixed to the inner circumferential surface of the rear end shaft and the straight portion of the core wire is press-fitted between the inner circumferential surface of the distal end shaft and the outer circumferential surface of the inner tube,
(L1) in the axial direction from the forming position of the guide wire port to the tip of the straight portion of the core wire is 1.0 to 50.0 mm,
The straight portion of the core wire is press-fitted so that the cross-section of the distal end shaft in the portion where the straight portion is press-fitted becomes an elliptic shape, and the long diameter of the ellipse is D 11 and the short diameter is D 12 , The value of (D 11 ) / (D 12 ) is 1.02 to 1.30.
According to the balloon catheter having such a configuration, the straight portion of the core wire fixed to the inner circumferential surface of the rear end shaft is press-fitted between the inner circumferential surface of the distal end shaft and the outer circumferential surface of the inner tube to fix (The region including the portion from the position where the guide wire port is formed to the tip end position of the rear end shaft) than the fixing position of the core wire, The rigidity of the shaft at the front end of the shaft can be made sufficiently high, so that it is possible to reliably prevent the kink at the portion.
Further, the core wire is not fixed firmly to the inner circumferential surface of the distal end shaft, but the core wire is fixed by pressing the straight portion between the inner circumferential surface of the distal end shaft and the outer circumferential surface of the inner tube, When the bending stress is exerted on the distal end shaft, the core wire can move (slide) in the axial direction with respect to the distal end shaft, thereby ensuring good flexibility in the distal end shaft As a result, the distal end shaft can be smoothly inserted into the curved blood vessel.
(2) In the balloon catheter of the present invention, the inner diameter of the resin tube constituting the distal shaft is d 1 , the outer diameter of the inner tube is D 2 , the diameter of the straight portion of the core wire is D 3 ), It is preferable that the value of D 3 / (d 1 -D 2 ) is 1.05 to 1.95. Note that the inner diameter d 1 of the resin tube is an inner diameter in a state in which the core wire is not inserted.
According to the balloon catheter having such a configuration, it is possible to impart an appropriate pressure (fitting force) between the inner peripheral surface of the distal end shaft and the outer peripheral surface of the inner tube with respect to the outer peripheral surface of the straight portion of the core wire, It combines rigidity and flexibility in a balanced manner.
The balloon catheter of the present invention is excellent in pushability when inserted into a blood vessel, and is capable of reliably kinking in the rear end portion (the portion from the position where the guide wire port is formed to the distal end position of the rear end shaft) It is possible to smoothly insert the blood vessel into a bent blood vessel.
1 is a cross-sectional view schematically showing a longitudinal section of a balloon catheter according to an embodiment of the present invention.
Fig. 2 is a cross-sectional view (aa sectional view, bb sectional view, cc sectional view, dd sectional view, and ee sectional view of Fig. 1) of a balloon catheter according to an embodiment of the present invention.
The
The
1,
The
The outer diameter (D 1 ) of the resin tube constituting the
The inner diameter d 1 of the resin tube constituting the
The outer diameter D 1 and the inner diameter d 1 are diameters in a state where the
The length of the
Examples of the constituent material of the front end shaft 10 (resin tube) include thermoplastic resins such as polyamide, polyether polyamide, polyurethane, polyester block amide (PEBAX) (registered trademark) and nylon, PEBAX is preferred.
It is preferable that the hardness of the tip side shaft 10 (resin tube) is 63 to 80 in hardness by the D type hardness meter.
A lumen (extension lumen) communicating with the lumen of the
The
As shown in Fig. 1, the metal tube constituting the
The outside diameter of the metal tube constituting the rear
The inner diameter of the metal tube constituting the
The length of the rear
A
The
The diameter of the
The length of the
As the constituent material of the
The
The rear end of the
The distal end of the
The outer diameter D 2 of the
The inner diameter (d 2 ) of the
The distance L3 in the axial direction from the formation position of the
The distance L4 in the axial direction from the position where the
As the constituent material of the
The hardness of the
The
The
The
The
The length of the portion extending from the position where the guide wire port is formed to the leading end position of the rear end shaft 20 (the length of the portion in FIG. 1) is smaller than the fixing position of the core wire 50 (straight portion 51) (Indicated by (L4) in the figure), the rigidity of the
The
When the tapered
When the
The diameter D 3 of the
The diameter D 3 of the
The diameter D 3 is adjusted so that the value of D 3 / (d 1 -D 2 ) is in the range of 1.05 to 1.95 to adjust the inner diameter of the inner tube of the inner tube 40). As a result, the
When the value of D 3 / (d 1 -D 2 ) is less than 1.05, the straight portion of the core wire can not be sufficiently fixed to the distal shaft. On the other hand, when the value of D 3 / (d 1 -D 2 ) exceeds 1.95, the straight portion of the core wire can not be press-fit between the inner peripheral surface of the distal end shaft and the outer peripheral surface of the inner tube, or the shaft cross- And the operability may be deteriorated in some cases.
In the
And, the value of this as the long diameter of the ellipse (D 11) and, when the short diameter to that (D 12), (D 11 ) / (D 12) is 1.02 to 1.30.
If the value of (D 11 ) / (D 12 ) in the ellipse is 1.02 to 1.30, the matching performance of the
When the value of (D 11 ) / (D 12 ) is less than 1.02, the straight portion of the core wire inserted into the lumen of the distal shaft is not sufficiently press-fitted and fixed, The effect of improving the rigidity at the rear end portion can not be sufficiently exhibited. Alternatively, there is a possibility that the lumen (guide wire lumen) of the inner tube is closed.
On the other hand, when the value of (D 11 ) / (D 12 ) is more than 1.30, it is impossible to accommodate the tip shaft of such a sectional shape in the guide shell, May fall.
The distance L1 in the axial direction from the formation position of the
When the distance L1 is too short, the core wire 50 (the straight portion 51) can not be sufficiently fixed (fitted and supported), the pushing ability is improved, the rigidity at the rear end portion of the distal- It is not possible to sufficiently exhibit the effect of improving the adhesion.
On the other hand, when the distance L1 is excessively long, the "directionality of bending" appears in the
The length L2 of the tapered
The
Although the embodiment of the present invention has been described above, the present invention is not limited to these embodiments, and various modifications are possible.
For example, the diameter-reduced portion of the core wire may be intermittently reduced in diameter in the tip direction.
Further, a plurality of straight portions having different diameters may be connected to the core wire through the diameter reduction portion. In this case, any one of the straight portions is press-fitted between the inner peripheral surface of the shaft at the front end side and the outer peripheral surface of the inner tube.
100: balloon catheter
10: Tip shaft
20: rear end shaft
30: Balloon
40: Inner tube
41: opening (guide wire port)
42: opening
50: core wire
51: Straight portion
52:
60: Hub
70: Strain Relief
Claims (2)
A rear end shaft including a metal tube connected to a rear end of the front end shaft,
A balloon connected to a distal end of the distal shaft,
Wherein the balloon is inserted into the lumen of the distal end shaft and inside the balloon to form a guide wire lumen, the rear end of the distal end shaft is opened as a guide wire port, An inner tube whose tip is opened,
And a core wire having a straight portion and a diameter reduction portion and having the diameter reduction portion as a distal end side and being inserted into a lumen of the distal end shaft,
The rear end side of the core wire is fixed to the inner circumferential surface of the rear end shaft and the straight portion of the core wire is press-fitted between the inner circumferential surface of the distal end shaft and the outer circumferential surface of the inner tube,
(L1) in the axial direction from the forming position of the guide wire port to the tip of the straight portion of the core wire is 1.0 to 50.0 mm,
The straight portion of the core wire is press-fitted so that the cross-section of the distal end shaft in the portion where the straight portion is press-fitted becomes an elliptic shape, and the long diameter of the ellipse is D 11 and the short diameter is D 12 , Wherein the value of (D 11 ) / (D 12 ) is from 1.02 to 1.30.
When that the inner diameter of the resin tube constituting the distal end side shaft (1 d), the outer diameter of the inner tube (D 2), the diameter of the straight portion of the core wire (D 3),
Wherein the value of D 3 / (d 1 -D 2 ) is from 1.05 to 1.95.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2013236311A JP5631475B1 (en) | 2013-11-14 | 2013-11-14 | Balloon catheter |
JPJP-P-2013-236311 | 2013-11-14 | ||
PCT/JP2014/078178 WO2015072300A1 (en) | 2013-11-14 | 2014-10-23 | Balloon catheter |
Publications (2)
Publication Number | Publication Date |
---|---|
KR20160049546A KR20160049546A (en) | 2016-05-09 |
KR101788491B1 true KR101788491B1 (en) | 2017-10-19 |
Family
ID=52144997
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
KR1020167008548A KR101788491B1 (en) | 2013-11-14 | 2014-10-23 | Balloon catheter |
Country Status (4)
Country | Link |
---|---|
JP (1) | JP5631475B1 (en) |
KR (1) | KR101788491B1 (en) |
CN (1) | CN105473177B (en) |
WO (1) | WO2015072300A1 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2024035786A1 (en) * | 2022-08-12 | 2024-02-15 | Boston Scientific Scimed, Inc. | Catheter with rapid exchange guidewire port and method of manufacture |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP6304886B2 (en) * | 2014-10-28 | 2018-04-04 | 日本ライフライン株式会社 | Balloon catheter |
JP6222763B1 (en) * | 2017-01-31 | 2017-11-01 | 日本ライフライン株式会社 | Balloon catheter |
WO2018181315A1 (en) | 2017-03-31 | 2018-10-04 | テルモ株式会社 | Balloon catheter and method for manufacturing medical elongated body |
CN107736884B (en) * | 2017-10-19 | 2018-10-12 | 深圳北芯生命科技有限公司 | Intravascular pressure with supporting mechanism measures conduit |
JP2020062320A (en) * | 2018-10-19 | 2020-04-23 | 朝日インテック株式会社 | catheter |
JP7352390B2 (en) | 2019-06-19 | 2023-09-28 | 朝日インテック株式会社 | catheter |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2002204832A (en) | 2001-01-10 | 2002-07-23 | Kawasumi Lab Inc | Coiled marker, catheter and balloon catheter |
JP2005028118A (en) | 2003-06-18 | 2005-02-03 | Nipro Corp | Balloon catheter suited to kissing technique |
JP2012020077A (en) | 2010-07-16 | 2012-02-02 | Kaneka Corp | Balloon catheter |
WO2013140669A1 (en) | 2012-03-23 | 2013-09-26 | テルモ株式会社 | Balloon catheter |
Family Cites Families (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5156594A (en) * | 1990-08-28 | 1992-10-20 | Scimed Life Systems, Inc. | Balloon catheter with distal guide wire lumen |
DE69322008T2 (en) * | 1992-02-10 | 1999-06-10 | Scimed Life Systems Inc | INTRAVASCULAR CATHETER WITH A DISTAL GUIDE WIRE LUMEN |
JP4774144B2 (en) * | 2000-07-18 | 2011-09-14 | 川澄化学工業株式会社 | Balloon catheter |
JP2003164528A (en) * | 2001-11-29 | 2003-06-10 | Nippon Sherwood Medical Industries Ltd | Balloon catheter |
US9289576B2 (en) * | 2004-06-17 | 2016-03-22 | W. L. Gore & Associates, Inc. | Catheter assembly |
JP5626731B2 (en) * | 2011-03-04 | 2014-11-19 | 朝日インテック株式会社 | Balloon catheter |
-
2013
- 2013-11-14 JP JP2013236311A patent/JP5631475B1/en active Active
-
2014
- 2014-10-23 KR KR1020167008548A patent/KR101788491B1/en active IP Right Grant
- 2014-10-23 CN CN201480045353.1A patent/CN105473177B/en active Active
- 2014-10-23 WO PCT/JP2014/078178 patent/WO2015072300A1/en active Application Filing
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2002204832A (en) | 2001-01-10 | 2002-07-23 | Kawasumi Lab Inc | Coiled marker, catheter and balloon catheter |
JP2005028118A (en) | 2003-06-18 | 2005-02-03 | Nipro Corp | Balloon catheter suited to kissing technique |
JP2012020077A (en) | 2010-07-16 | 2012-02-02 | Kaneka Corp | Balloon catheter |
WO2013140669A1 (en) | 2012-03-23 | 2013-09-26 | テルモ株式会社 | Balloon catheter |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2024035786A1 (en) * | 2022-08-12 | 2024-02-15 | Boston Scientific Scimed, Inc. | Catheter with rapid exchange guidewire port and method of manufacture |
Also Published As
Publication number | Publication date |
---|---|
JP2015093173A (en) | 2015-05-18 |
JP5631475B1 (en) | 2014-11-26 |
WO2015072300A1 (en) | 2015-05-21 |
KR20160049546A (en) | 2016-05-09 |
CN105473177A (en) | 2016-04-06 |
CN105473177B (en) | 2018-07-17 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
KR101788491B1 (en) | Balloon catheter | |
EP2143462A2 (en) | Rapid exchange catheter having a support mandrel | |
EP2517749A1 (en) | Catheter | |
EP2389973A1 (en) | Balloon catheter | |
US11065423B2 (en) | Balloon catheter | |
CN105358208B (en) | Catheter tube | |
US10617855B2 (en) | Balloon catheter | |
EP2399641A1 (en) | Balloon catheter | |
JP6304711B2 (en) | Balloon catheter | |
EP2399642A1 (en) | Balloon catheter | |
JP5154188B2 (en) | Balloon catheter | |
JP6799901B2 (en) | catheter | |
US9446217B2 (en) | Catheter | |
KR101997373B1 (en) | Balloon catheter | |
JP6804802B2 (en) | Balloon catheter | |
JP6906883B2 (en) | Balloon catheter | |
JP6399809B2 (en) | Medical guidewire | |
JP2013106797A (en) | Balloon catheter |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
A201 | Request for examination | ||
E701 | Decision to grant or registration of patent right |