WO1994022521A1 - Predilating wire for angioplasty - Google Patents
Predilating wire for angioplasty Download PDFInfo
- Publication number
- WO1994022521A1 WO1994022521A1 PCT/GB1994/000680 GB9400680W WO9422521A1 WO 1994022521 A1 WO1994022521 A1 WO 1994022521A1 GB 9400680 W GB9400680 W GB 9400680W WO 9422521 A1 WO9422521 A1 WO 9422521A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- guide wire
- wire
- distal tip
- enlarged portion
- balloon
- Prior art date
Links
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
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
-
- 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
- A61M25/09—Guide wires
-
- 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
- A61M25/09—Guide wires
- A61M2025/09008—Guide wires having a balloon
-
- 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
- A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics
Definitions
- This invention relates to a predilating wire for use in the treatment of stenotic or occluded arteries, particularly coronary arteries or by-pass grafts.
- a balloon catheter of a single lumen type having a guide wire which is of tapering form, the extreme distal tip of the guide wire having a hemispherical enlarged tip and a spherical valve member spaced from the extreme tip which can be drawn back against the distal end of the balloon.
- the spherical valve member seals the distal end of the balloon so that the single lumen can be inflated.
- the guide wire has a tapering form with the hemispherical tip and spherical valve member being provided on the thinnest portion, a slightly thicker portion passing through the balloon, and a thicker portion extending to the proximal end of the assembly.
- This tapering construction of the guide wire means that the balloon has to be kept close to the extreme distal tip of the guide wire since the thick portion of the guide wire will not pass through the balloon.
- the blunt hemispherical tip also requires initial force to cross a stenotic or occluded segment of artery as referred to above.
- the assembly lacks manoeuvrability, particularly since the catheter has to be passed with the guide wire, that is the guide wire is not removable from the assembly.
- a guide wire which is constructed and adapted to guide a balloon catheter to a desired position in an artery, said guide wire having a distal end region including a distal tip of minimum cross-section and a portion of enlarged cross-section at a location thereon which is spaced from the distal tip.
- the enlarged portion is preferably tapered so that the cross- sectional area thereof reduces in the direction of the distal tip.
- the distal tip may be of smaller cross-section than the remainder of the wire.
- the distal tip region may be more flexible than the remainder of the wire.
- the guide wire itself may be constructed in a conventional fashion with a stainless steel mandrel forming the inner core of the wire, and a coating of a non-thrombogenic, smooth polymer layer to facilitate passage of the balloon catheter thereover.
- the distal tip region of the guide wire may have the mandrel omitted.
- the proximal end of the enlarged portion may have a diameter which is approximately equal to the minimum un-inflated diameter of a balloon catheter to be used in conjunction with the guide wire.
- the enlarged portion is located a few centimetres, typically about 20 mm to 30 mm, most preferably about 30 mm, from the distal tip.
- the wire over the length of the distal end region between the distal tip and the enlarged portion may have a greater degree of flexibility than the region of the wire which is on the proximal side of said enlarged portion.
- the length of the enlarged portion is typically about 3 mm to 6 mm.
- the guide wire may have a diameter of between 0.25 mm and 0.45 mm.
- the enlarged portion may taper from the thickness of the wire up to about 1.0 mm in diameter. (The size will be selected to be compatible with the size of the balloon with which it is to be used)
- the present invention also resides in a balloon catheter assembly comprising a balloon catheter in combination with a guide wire according to the present invention.
- the balloon catheter may be a twin lumen catheter or a single lumen catheter. It may be of a monorail type.
- Fig 1 is a schematic view of a guide wire according to the present invention.
- Fig 2 is a schematic view showing use of the guide wire of Fig 1 in conjunction with a balloon catheter.
- the guide wire 10 is of extended length, typically 1500 mm, and is formed of a stainless steel inner core coated with a non-thrombogenic, smooth polymer layer to facilitate sliding movement of the balloon catheter in use.
- the inner core of the wire tapers at the distal end region 12 and may stop a few centimetres short of the end.
- the guide wire has a diameter, in this embodiment, of 0.25 mm, although it may have a larger diameter, eg 0.45 mm.
- the distal end region 12 has a length "a" which in this embodiment is about 30 mm. This distal end region 12 has a flexibility which is greater than the remainder of the guide wire 10 and which is sufficient to enable it to be steered along the desired path.
- the distal end region 12 terminates in a fine, rounded distal tip 14 having a diameter which is no greater than the remainder of the region 12.
- the guide wire 10 is provided with a portion 16 of enlarged cross-section defined by a frusto-conically tapering enlarged portion whose diameter decreases towards the distal tip 14 where it merges with that of the wire.
- the enlarged portion 16 has a length of about 10 mm.
- the frustum (ie the distal end) of the enlarged portion 16 has a diameter which equals that of the region 12 whilst the base (i.e. the proximal end) of the enlarged portion 16 has a diameter which is equal to up to 1.0 mm in this embodiment.
- the length of the enlarged portion should be as short as reasonably possible, so as not to reduce the flexibility of the wire too greatly.
- a suitable length may be 3 mm to 6 mm, and may vary in proportion to the maximum diameter and hence the balloon size, to give a suitable taper angle between about 10° and 40°.
- the guide wire 10 is inserted into an artery in the leg of a patient having a stenotic coronary artery using a guide catheter and is passed along the artery until the distal tip 14 has passed through the stenosis in the coronary artery. Because the distal tip 14 is of a relatively small diameter, the minimum diameter of the guide wire, this does not require a very large force. In turn, this permits the diameter of the guide wire 10 as a whole to be small since the longitudinal force needed for insertion is low. At this stage, the distal tip 14 lies on the opposite side of the stenosis from the enlarged portion 16.
- a balloon catheter comprising a balloon 20 in an un-inflated condition fixed to the distal end of a catheter 22, is inserted into the artery over the guide wire 10 in a manner known per se and slid along the artery until the distal end of the catheter 22 abuts against the base end of the enlarged portion 16 of the guide wire 10 (as shown in Fig 2) .
- the diameter of the base of the enlarged portion 16 is approximately equal to the outer diameter of the balloon 20 when in its un-inflated condition.
- the catheter can be brought to the stenotic or occluded segment of the artery and the balloon can then be inflated for use.
- the guide wire can be passed through the stenosis using the manoeuvrability of the relatively soft and very fine tip, the tapered enlarged portion can then be used to slightly open the stenosis until the enlarged portion of the wire itself can be passed through. This opens up the vessel slightly so that it does not damage the relatively soft balloon tip of the catheter.
- the wire can be slightly withdrawn to position the balloon catheter against the base of the frusto-conically tapering enlarged portion 16 as shown in Figure 2 and locked in position so that the catheter and wire are subsequently moved as a unit through the stenosis to enable the balloon to be deployed.
- the device therefore allows for a gentle passage of the flexible tip, slight opening up of the stenosis and the subsequent deployment of the balloon without damage to it. Because of the tapering shape of the enlarged portion, the longitudinal force on the wire tends to centralise the device in the occluded artery, making passage of the balloon easier.
- the enlarged portion 16 protects the balloon 20 against deformation and damage as it is being passed into the stenosis in the artery.
- the general reduction in the diameter of balloon catheters (to allow the use of smaller bore guiding catheters in order to reduce the size of the arterial puncture) has also led to a reduced strength of the shaft of the balloon catheter.
- the present invention mitigates this problem by enabling the catheter 22 and wire 10 to be finally advanced as a unit with the enlarged portion 16 forcing a passage through the stenosis.
- the flexible distal end region 12 keeps the parts inside the lumen of the artery with no risk to perforation of the arterial wall. This is particularly important in total or near total occlusion, where traverse of the guide wire itself through the . occlusion does not necessarily result in successful balloon crossing.
- the guide wire of the present invention can be used with all current balloon catheter systems that employ a freely moveable wire.
- the present invention is also applicable to balloon catheter systems of the so-called "mono-rail" type where the guide wire extends through the balloon catheter for only a relatively short distance behind the balloon before emerging through a hole in the wall of the balloon catheter.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Anesthesiology (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Child & Adolescent Psychology (AREA)
- Vascular Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP94911249A EP0691867A1 (en) | 1993-04-03 | 1994-03-31 | Predilating wire for angioplasty |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB939307089A GB9307089D0 (en) | 1993-04-03 | 1993-04-03 | Predilating wire for angioplasty |
GB9307089.4 | 1993-04-03 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1994022521A1 true WO1994022521A1 (en) | 1994-10-13 |
Family
ID=10733367
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/GB1994/000680 WO1994022521A1 (en) | 1993-04-03 | 1994-03-31 | Predilating wire for angioplasty |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP0691867A1 (en) |
GB (1) | GB9307089D0 (en) |
WO (1) | WO1994022521A1 (en) |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1986006285A1 (en) * | 1985-05-02 | 1986-11-06 | C. R. Bard, Inc. | Microdilatation probe and system for performing angioplasty |
WO1988000844A1 (en) * | 1986-08-08 | 1988-02-11 | Scimed Life Systems, Inc. | Angioplasty dilating guide wire |
WO1990005557A1 (en) * | 1988-11-23 | 1990-05-31 | Boston Scientific Corporation | Medical guidewire |
WO1991015152A1 (en) * | 1990-04-10 | 1991-10-17 | Boston Scientific Corporation | High elongation linear elastic guidewire |
US5141494A (en) * | 1990-02-15 | 1992-08-25 | Danforth Biomedical, Inc. | Variable wire diameter angioplasty dilatation balloon catheter |
-
1993
- 1993-04-03 GB GB939307089A patent/GB9307089D0/en active Pending
-
1994
- 1994-03-31 WO PCT/GB1994/000680 patent/WO1994022521A1/en not_active Application Discontinuation
- 1994-03-31 EP EP94911249A patent/EP0691867A1/en not_active Withdrawn
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1986006285A1 (en) * | 1985-05-02 | 1986-11-06 | C. R. Bard, Inc. | Microdilatation probe and system for performing angioplasty |
WO1988000844A1 (en) * | 1986-08-08 | 1988-02-11 | Scimed Life Systems, Inc. | Angioplasty dilating guide wire |
WO1990005557A1 (en) * | 1988-11-23 | 1990-05-31 | Boston Scientific Corporation | Medical guidewire |
US5141494A (en) * | 1990-02-15 | 1992-08-25 | Danforth Biomedical, Inc. | Variable wire diameter angioplasty dilatation balloon catheter |
WO1991015152A1 (en) * | 1990-04-10 | 1991-10-17 | Boston Scientific Corporation | High elongation linear elastic guidewire |
Also Published As
Publication number | Publication date |
---|---|
GB9307089D0 (en) | 1993-05-26 |
EP0691867A1 (en) | 1996-01-17 |
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