CA2184484A1 - Catheter guidewire with radiopaque markers - Google Patents
Catheter guidewire with radiopaque markersInfo
- Publication number
- CA2184484A1 CA2184484A1 CA002184484A CA2184484A CA2184484A1 CA 2184484 A1 CA2184484 A1 CA 2184484A1 CA 002184484 A CA002184484 A CA 002184484A CA 2184484 A CA2184484 A CA 2184484A CA 2184484 A1 CA2184484 A1 CA 2184484A1
- Authority
- CA
- Canada
- Prior art keywords
- coil
- distal
- proximal
- radiopaque
- sleeve
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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
- A61M25/01—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
- A61M2025/09058—Basic structures of guide wires
- A61M2025/09083—Basic structures of guide wires having a coil around a core
- A61M2025/09091—Basic structures of guide wires having a coil around a core where a sheath surrounds the coil at the distal part
-
- 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
- A61M2025/09166—Guide wires having radio-opaque features
-
- 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
- A61M2025/09175—Guide wires having specific characteristics at the distal tip
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Materials For Medical Uses (AREA)
Abstract
A guidewire for use with a catheter has varying radiopacity as well as at least one radiopaque marker in its distal end. In one embodiment, the guidewire includes a shaft having a distal radiopaque coil supported by and attached to a distal portion of the shaft and a proximal radiopaque coil supported by and attached to an intermediate portion of the shaft. The proximal and distal coils are spaced apart from one another. The distal coil may be more radiopaque than or equally radiopaque to the proximal coil such that when viewed under fluoroscopy, the highly radiopaque coil will define a dark image whereas the more proximal radiopaque coil will define a moderately radiopaque image or both will define a dark image. The area between the two coils will appear white. Between the coils, at least one radiopaque marker band is attached to the shaft. The marker bands provide several reference lengths for a physician. A polymer sleeve encases the marker bands and the shaft between the first and second coils providing a uniform outer diameter to the distal region of the guidewire. In another embodiment, the proximal coil of the first embodiment is absent and the polymer sleeve extends proximally of the radiopaque marker bands. In a further embodiment, a radiopaque coil having varying pitch along its length is supported by and attached to a distal region of the core wire.
Description
wo 9sl2~237 ,, ~ ~ PCT~rS95/03076 t~AT~T~TF~R ~:rU.~ ,Wlh'~ NIT~T RAT)IOppt~uE MARR~RR
RF~T.~TT"n AppTlT(~z~TIoN
This application is a rrlntlnll~tion-in-part of application Serial No. 08/212,558, filed March ll, 1994.
FJ~T n OF T~T~ IN~ENTION
The invention relates to guidewires used to support and guide dilatation catheters as they are advanced through body lumens such as blood vessels.
R(.RO~lNn OF T~ INVENTI( 1N
A wide variety of guidewires are used for various medical purposes in the treatment of the human body. Typically guidewires are used to guide a catheter to a site within a patient ' s blood vessel to perform the procedure for which the catheter is adapted. For e~mple, guidewires, particularly small diameter steerable guidewires, perform the important function in percutaneous transluminal coronary a~gioplasty of guiding a balloon catheter such that the balloor~ can be placed at the s~te of the stenosis (obstruction) to be treated. The balloon is then inflated to dilate the stenosis and subsequently increase the blood f low through the artery .
SUBSTITUTE SHEET (RUI E 26) W095/21237 2 } 8 4 4 8 4 r ~ 03Q76 Typical angioplasty steerabie guidewires include a torsionally rigid, longitudinaliy flexible shaft and a f lexible distal end that includes a coil, all or part of which may be radiopaoue, so that a physician can monitor fluoroscopically the position and advancement of the guidewi re .
During procedures, such as coronary angioplasty, it is often the practice to inject a radiopaque contrast liquid into the artery so that the shape and path of the artery, particularly in the region of the stenosis, may be visualized 1uoroscopically. The radiopacity of some guidewire coils may be so dense as to visually obstruct the stenosed part of the artery when the contrast liquid is injected. As a result of the visual obstruction, the ability of the physician to visualize and assess the nature of the stenosis is impaired.
U.S. Patent No. ~,144,959 (Gambale) describes a guidewire which does not visually obstruct the desired part of the artery when contrast liquid is injected. The distal region of the Gambale guidewire includes a coil having a highly radiopaque distal portion, a moderately radiopaque proximal portion and a non-radiopague ; nt~ ate portion . The guidewire may be advanced so that its distal portion advances through and beyond the stenosis while the non-radiopaque portion is disposed at the region of the stenosis to prevent visual obstruction. The moderately radiopague proximal portion provides an indication of the position and configuration of the more proximally located portions of the guidewire. Thorough assessment of the stenosis, however, is difficult without ~he provision of a visual reference len-gth.
SU~SrIME SHEET (RULE 26~
~r, ~. ` y<~',' advanced 80 that its distal portion advances through and beyond the stenosis while the non-radiopa~ue portion is disposed at the region o~ the stenosis to prevent vi~ual obstruction. The moderately radiopa~ue proximal portion provides an indication of the position and configuration of the more proximally located portions of the guidewire.
Thorough assessment of the stenosis, however, is difficult without the provision of a visual reference length .
AMENDED SHEET
IPEA/EP
~'0 '~ 3~ PCT~IS9~ 3()7~
3 2 1 ~3 4 4 8 4 The proYisiOn o~ a visible reference length would enable the physician to make in vivo measurements of the lesion to determine its length and shape and dimensions o~ the artery ad~acent to the lesion. The assessment facilitates the selection of an appropriately sized balloon catheter anl, additionally, in the event that a stent is needed to prevent the artery from collapsing in the area of the lesion, aids in the selection of an appropriately sized stent. It is, therefore, desirable for the distal region of non-obstructin~
guidewires to include a highly radiopaque distal section and more proximal uniformly spaced radiopaque markers, which provide such a reference length.
It is among the gene~al objects of the invention to provide guidewires having the foregoing desirable characteristics .
S~RY aF THE INVENTION
A guidewire, in accordance ~ith the invention, has an elongate f lexible shaft . In a f irst ~ of the invention, a distal radiopaque coil is ~ uL~ed about and is att~rhod to a distal portion of the shaft. A prûximal radlopaque coil is supported about and is attached to a distal portion of the shaft, spaced proximally from the distal coil. The distal coil may be more rA~l~oF~u~ than the proximal coil which would make it appear darker than the proximal coil under fluoroscopy. The two coils may have identical radiopacity. A polymer sleeve encases the shaft between the distal and proximal coils, its ends overlapping the proximal end of the distal coil and the distal end of the SU8STlTllTE SHEET (RUL 26) wo 9sl2~37 PCTIUS95/03076 1 8 4 4 8 4 o proximal coil. The guidewire also includes at least one radiopague marker band attached to the shaf t between the distal and proximal coils and encased by the polymer sleeve.
Thus, the guidewire provides a distal region having a highly radiopague distal portion, a non-radiopaque intermediate portion (except for the radiopaque markers), and a moderately or highly radiopaque proximal portion.
In a second ~ of the invention, a radiopaque coil is supported about and is attached to the distal portion of the distal region of the shaft. At least one radiopaque marker band is attached to the proximal portion of the distal region of the shaft. A polymer sleeve encases the marker bands and the proximal portion of the distal region of the shaft. In this embodiment, the guidewire provides a distal region having a highly radiopas~ue distal portion and a non-radiopaque proximal portion (except for the radiopaque markers ) .
In a third embodiment of the invention, a radiopaque coil is supported about and is attached to the distal region of the shaft. The coil has varying pitch along its length and includes highly radiopaque distal and proximal sections and a moderately radiopague ;nter ~l;ate section. The guidewire may also include an additional small radiopa~aue coil attached to the distal end of the guidewire and located within the distal section of the coil for increased radiopacity in the distar section. The intermediate section may include one or more tightly wound coil sections. Each coil section appears as a dark marker under fluoroscopy, and is separated from the proximal and distal sections by loosely wound coil sections, which appear lighter under fluoroscopy. A polymer sleeve SUBSTITUTE SHEET (RULE 26) wo gsl2~237 ~ ~ ~ " ~ , 2 1 8 4 4 8 4 PC rlUsgs/03076 encases the coil along a majority of the length of the coil.
Thus, the guidewire provides a distal region having highly radiopaque distal and proximal portions and a very lightly radiopaque inte -~liate portion (except for the darker radiopaoue markers ) .
In a fourth em~odiment of the invention, a radiopaoue coil is supported about and is attached to the distal region of the shaft. The coil has varying pitch along its leng~h and includes highly radiopaque distal and proximal sections and a lightly radiopaque intermediate window section. The int~ -~iatp window section may include one or more smaller tightly wound coil sections separated by loosely wound coil sections. Each smaller tightly wound coil section appears as a dark marker under f luoroscopy. A polymer sleeve encases the int~ te window section of the coil. The sleeve is attached to the guidewire only at the ends of the sleeve by heat shrinking the ends of the sleeve to the tightly wound coils immediately adjacent the int~rr~ iate window section.
A small gap exists between the coils of the intermediate window section and the sleeve such that the contour of the coils in the window section do not project through the sleeve. Thus, the guidewire provides a distal region having highly radiopaque distal and proximal portions and a lightly radiopaque intermediate- portion (except for the darker radiopaque markers ) .
The guidewire of the invention is int~n~lPd to be used such that the ~on-radiopas;ue section ( if using the guidewire of the first or second ~mhsrlim~nts), or lightly radiopaque section ( if using the guidewire of the third or fourth ~mhcu1i tc), is placed within the stenosed region of the SU8S1 1TUTE SHEET (RULE 26~
WO9~12.1237 ~ i- 2 ~ 84484 PCT~TS95103076 artery so that the radiopacity of the guidewire will not interfere with the fluoroscopic imaging of the stenosis when the artery is injected with radiopaque contrast liquid. The radiopaque markers provide a reference for the physician to measure the length of the stenosis, the dimensions of the adjacent arterial area, and/or to mark the location of a lesion or a stent. Thus, the markers aid in the selection of an appropriate balloon and, if necessary, in the selection of an appropriate stent. This invention allows the physician to do this regardless of visualization angle or degree of fluoroscopic magnification. The polymer sleeve insulates the spaced coils or bands from the inner arterial wall and provides a uniform outer diameter (in some embodiments) to the distal region of the guidewire such that a catheter will smoothly move over the guidewire.
DEST-RIPTION OF THE DRAWI~iTGS
The foregoing and other objects and advantages of the invention will be appreciated more fully from the following further description thereof, with reference to the ~-c ~ ying drawings wherein:
FIG. 1 is a longitudinal sectional frT~J ~od illustration of f irst embodiment of the invention;
FI~. 2 is a longitudinal sectional fra~ d illustration of a second embodiment of the invention;~
FIG. 3 is a longitudinal sectional fragmented illustration of a third embodiment of the invention;
FIG. 4 is a longitudinal sectional fragmented illustration of a variation to the third em~odiment of the invent ion: and SUBSTIME SHEET (RUL~
j ~ 2 1 84484 so410/7227WO
FIG. 5 is a longitudinal sectional fragmented illustration of a fourth embodiment of the invention.
It is to be appreciated that the figures are not drawn to scale and are highly diagrammatic to illustrate the concepts of the invention.
DT'C~RTPTION OF T~T~ TT,T,USTR;~TIVE F~ lF3ODTl~FiNT
FIG. 1 shows a first embodiment of the invention. As shown, the guidewire, when ;nt~n~Pd for percutaneous transluminal coronary angioplasty may be approximately 175 cm to 300 cm in total length and_includes an elongated rotationally rigid, longitudinally flexible core wire 10, preferably made of stainle3s steel or other material suitable for use as a guidewire shaft. The majority of the length ~approximately 148 cm to 273 cm) is in the proximal segment ll of the core wire which ha~ a substantially uniform diameter of approximately 0 . 25 to 0 . 457 mm (0.010 to 0.018 inches). The proximal segment 11 merges into a first tapered segment 12, about 3 cm long which, in turn, merges into an intermediate barrel segment 14, approximately 22 . 5 cm long and about 6 mils in diameter. Intermediate segment 14 merges into a second tapered segment 15, about 3 cm long which, in turn, merges into a distal barrel segment 16, about 2.5 cm long and approximately . 05 mm (2 mils) in diameter. The distal segment 16 is more f lexible than the intermediate segment 14 .
Alternatively, the core wire (from taper 12 to distal segment 16) may have a continuous taper along its length.
AMENDED SHEEr I PEA/EP
~ 2 ~ ~4484 so410/7227Wo A distal coil 18, approximately 3 cm in length, is supported about the distal segment of the core wire and preferably is attached at its proximal end to the core wire by adhesive at joint 20. Suitable adhesives include an ultraviolet curable adhesive or a cyanoacrylate adhesive. The joint 20 alternatively may be welded, soldered or brazed. The distal coil 18 is attached at its distal end to the core wire by a distal hemispherical tip weld 22. The distal coil may be formed from a highly radiopaque material such as a gold/platinum or platinum/tungsten alloy. In a guidewire intended for use in percutaneous transluminal coronary angioplasty, the diameter of the wire from which the distal coil 18 is wound preferably is within the range of 0 . 025-0 .102mm ( . 001- . 004 inches) . The outer diameter of the distal coil 18 preferably is within the range of 0.25 - 0.46 mm (.010-.018 inches).
A proximal coil 24 is 3upported about the intermediate segment 14 of the core wire and is preferably attached at its distal end to the core wire by adhesive at joint 26. The proximal end of coil 24 extend3 to the proximal end of the intermediate segment 14 of the core wire where it may be attached to the core wire by adhesive at joint 25. Joints 25 and 26 may alternatively be welded, soldered or brazed. The outer diameter of the proximal coil is preferably the same as that of the distal coil 18. The proximal coil preferably is 7-22 cm in length. The proximal coil 24 may be less radiopaque than the distal coil 18 or of equivalent radiopacity. The proximal coil preferably is formed from the same material a~ the distal coil but may be formed from smaller diameter wire to achieve the desired reduced radiopacity . AMENDED SHEFT
IPtAlEP
21 844~4 B0410t7227WO
g The region of the guidewire between the proximal and distal coils, inr]ll~;nJ a portion of the int~ te segment 14 and tapered segment 15, is covered by a f lexible polymeric sleeve 34 .
The sleeve, preferably having an outer diameter er~ual to that of the proximal and distal coils, provides a uniform outer ,1; i tPr to the distal region of the guidewire such that the catheter will -smoothly move over the guidewire during advi~nrpm~nt~ The sleeve preferably is flexible, kink resistant and includes a lubricious surface for aiding in guidewire maneuverability. The sleeve preferably is formed from a polymer material (such as polyamide or polyethrlene) which exhibits the above properties. A
hydrophilic or hydrophobic coating may be used to coat the outer surface of the polymer sleeve for added lubricity.
The sleeve preferably is as thin as is practical, depending on the polymer material from which the 81eeve iiY made, in order that the region of the sleeve displays a desired degree of flexibility. The wall thickness of the sleeve preferably falls within the range of 0.005 - 0.05 mm (.0002-.002 inches). The sleeve preferably covers the proximal end of the distal coil and the distal end of the proximal coil and may be 5-20 cm in length.
As shown in FIG. 1, the distal end of the proximal coil 24 and the proximal end of the distal coil 18 can be stretched and tapered down to a smaller diameter in the region where they are attached to the core wire and overlapped by the ends of the polymer sleeve 34. The polymer sleeve preferably is adhesively attached at both ends to the guidewire. If adhesively attached, a small gap 23 exists between the inner surface of the sleeve and outer surfaces of AMENDE~ SHEET
IPEA/EP
. _ , . , .. , .. , . . , _ . . .. .. .
RF~T.~TT"n AppTlT(~z~TIoN
This application is a rrlntlnll~tion-in-part of application Serial No. 08/212,558, filed March ll, 1994.
FJ~T n OF T~T~ IN~ENTION
The invention relates to guidewires used to support and guide dilatation catheters as they are advanced through body lumens such as blood vessels.
R(.RO~lNn OF T~ INVENTI( 1N
A wide variety of guidewires are used for various medical purposes in the treatment of the human body. Typically guidewires are used to guide a catheter to a site within a patient ' s blood vessel to perform the procedure for which the catheter is adapted. For e~mple, guidewires, particularly small diameter steerable guidewires, perform the important function in percutaneous transluminal coronary a~gioplasty of guiding a balloon catheter such that the balloor~ can be placed at the s~te of the stenosis (obstruction) to be treated. The balloon is then inflated to dilate the stenosis and subsequently increase the blood f low through the artery .
SUBSTITUTE SHEET (RUI E 26) W095/21237 2 } 8 4 4 8 4 r ~ 03Q76 Typical angioplasty steerabie guidewires include a torsionally rigid, longitudinaliy flexible shaft and a f lexible distal end that includes a coil, all or part of which may be radiopaoue, so that a physician can monitor fluoroscopically the position and advancement of the guidewi re .
During procedures, such as coronary angioplasty, it is often the practice to inject a radiopaque contrast liquid into the artery so that the shape and path of the artery, particularly in the region of the stenosis, may be visualized 1uoroscopically. The radiopacity of some guidewire coils may be so dense as to visually obstruct the stenosed part of the artery when the contrast liquid is injected. As a result of the visual obstruction, the ability of the physician to visualize and assess the nature of the stenosis is impaired.
U.S. Patent No. ~,144,959 (Gambale) describes a guidewire which does not visually obstruct the desired part of the artery when contrast liquid is injected. The distal region of the Gambale guidewire includes a coil having a highly radiopaque distal portion, a moderately radiopaque proximal portion and a non-radiopague ; nt~ ate portion . The guidewire may be advanced so that its distal portion advances through and beyond the stenosis while the non-radiopaque portion is disposed at the region of the stenosis to prevent visual obstruction. The moderately radiopague proximal portion provides an indication of the position and configuration of the more proximally located portions of the guidewire. Thorough assessment of the stenosis, however, is difficult without ~he provision of a visual reference len-gth.
SU~SrIME SHEET (RULE 26~
~r, ~. ` y<~',' advanced 80 that its distal portion advances through and beyond the stenosis while the non-radiopa~ue portion is disposed at the region o~ the stenosis to prevent vi~ual obstruction. The moderately radiopa~ue proximal portion provides an indication of the position and configuration of the more proximally located portions of the guidewire.
Thorough assessment of the stenosis, however, is difficult without the provision of a visual reference length .
AMENDED SHEET
IPEA/EP
~'0 '~ 3~ PCT~IS9~ 3()7~
3 2 1 ~3 4 4 8 4 The proYisiOn o~ a visible reference length would enable the physician to make in vivo measurements of the lesion to determine its length and shape and dimensions o~ the artery ad~acent to the lesion. The assessment facilitates the selection of an appropriately sized balloon catheter anl, additionally, in the event that a stent is needed to prevent the artery from collapsing in the area of the lesion, aids in the selection of an appropriately sized stent. It is, therefore, desirable for the distal region of non-obstructin~
guidewires to include a highly radiopaque distal section and more proximal uniformly spaced radiopaque markers, which provide such a reference length.
It is among the gene~al objects of the invention to provide guidewires having the foregoing desirable characteristics .
S~RY aF THE INVENTION
A guidewire, in accordance ~ith the invention, has an elongate f lexible shaft . In a f irst ~ of the invention, a distal radiopaque coil is ~ uL~ed about and is att~rhod to a distal portion of the shaft. A prûximal radlopaque coil is supported about and is attached to a distal portion of the shaft, spaced proximally from the distal coil. The distal coil may be more rA~l~oF~u~ than the proximal coil which would make it appear darker than the proximal coil under fluoroscopy. The two coils may have identical radiopacity. A polymer sleeve encases the shaft between the distal and proximal coils, its ends overlapping the proximal end of the distal coil and the distal end of the SU8STlTllTE SHEET (RUL 26) wo 9sl2~37 PCTIUS95/03076 1 8 4 4 8 4 o proximal coil. The guidewire also includes at least one radiopague marker band attached to the shaf t between the distal and proximal coils and encased by the polymer sleeve.
Thus, the guidewire provides a distal region having a highly radiopague distal portion, a non-radiopaque intermediate portion (except for the radiopaque markers), and a moderately or highly radiopaque proximal portion.
In a second ~ of the invention, a radiopaque coil is supported about and is attached to the distal portion of the distal region of the shaft. At least one radiopaque marker band is attached to the proximal portion of the distal region of the shaft. A polymer sleeve encases the marker bands and the proximal portion of the distal region of the shaft. In this embodiment, the guidewire provides a distal region having a highly radiopas~ue distal portion and a non-radiopaque proximal portion (except for the radiopaque markers ) .
In a third embodiment of the invention, a radiopaque coil is supported about and is attached to the distal region of the shaft. The coil has varying pitch along its length and includes highly radiopaque distal and proximal sections and a moderately radiopague ;nter ~l;ate section. The guidewire may also include an additional small radiopa~aue coil attached to the distal end of the guidewire and located within the distal section of the coil for increased radiopacity in the distar section. The intermediate section may include one or more tightly wound coil sections. Each coil section appears as a dark marker under fluoroscopy, and is separated from the proximal and distal sections by loosely wound coil sections, which appear lighter under fluoroscopy. A polymer sleeve SUBSTITUTE SHEET (RULE 26) wo gsl2~237 ~ ~ ~ " ~ , 2 1 8 4 4 8 4 PC rlUsgs/03076 encases the coil along a majority of the length of the coil.
Thus, the guidewire provides a distal region having highly radiopaque distal and proximal portions and a very lightly radiopaque inte -~liate portion (except for the darker radiopaoue markers ) .
In a fourth em~odiment of the invention, a radiopaoue coil is supported about and is attached to the distal region of the shaft. The coil has varying pitch along its leng~h and includes highly radiopaque distal and proximal sections and a lightly radiopaque intermediate window section. The int~ -~iatp window section may include one or more smaller tightly wound coil sections separated by loosely wound coil sections. Each smaller tightly wound coil section appears as a dark marker under f luoroscopy. A polymer sleeve encases the int~ te window section of the coil. The sleeve is attached to the guidewire only at the ends of the sleeve by heat shrinking the ends of the sleeve to the tightly wound coils immediately adjacent the int~rr~ iate window section.
A small gap exists between the coils of the intermediate window section and the sleeve such that the contour of the coils in the window section do not project through the sleeve. Thus, the guidewire provides a distal region having highly radiopaque distal and proximal portions and a lightly radiopaque intermediate- portion (except for the darker radiopaque markers ) .
The guidewire of the invention is int~n~lPd to be used such that the ~on-radiopas;ue section ( if using the guidewire of the first or second ~mhsrlim~nts), or lightly radiopaque section ( if using the guidewire of the third or fourth ~mhcu1i tc), is placed within the stenosed region of the SU8S1 1TUTE SHEET (RULE 26~
WO9~12.1237 ~ i- 2 ~ 84484 PCT~TS95103076 artery so that the radiopacity of the guidewire will not interfere with the fluoroscopic imaging of the stenosis when the artery is injected with radiopaque contrast liquid. The radiopaque markers provide a reference for the physician to measure the length of the stenosis, the dimensions of the adjacent arterial area, and/or to mark the location of a lesion or a stent. Thus, the markers aid in the selection of an appropriate balloon and, if necessary, in the selection of an appropriate stent. This invention allows the physician to do this regardless of visualization angle or degree of fluoroscopic magnification. The polymer sleeve insulates the spaced coils or bands from the inner arterial wall and provides a uniform outer diameter (in some embodiments) to the distal region of the guidewire such that a catheter will smoothly move over the guidewire.
DEST-RIPTION OF THE DRAWI~iTGS
The foregoing and other objects and advantages of the invention will be appreciated more fully from the following further description thereof, with reference to the ~-c ~ ying drawings wherein:
FIG. 1 is a longitudinal sectional frT~J ~od illustration of f irst embodiment of the invention;
FI~. 2 is a longitudinal sectional fra~ d illustration of a second embodiment of the invention;~
FIG. 3 is a longitudinal sectional fragmented illustration of a third embodiment of the invention;
FIG. 4 is a longitudinal sectional fragmented illustration of a variation to the third em~odiment of the invent ion: and SUBSTIME SHEET (RUL~
j ~ 2 1 84484 so410/7227WO
FIG. 5 is a longitudinal sectional fragmented illustration of a fourth embodiment of the invention.
It is to be appreciated that the figures are not drawn to scale and are highly diagrammatic to illustrate the concepts of the invention.
DT'C~RTPTION OF T~T~ TT,T,USTR;~TIVE F~ lF3ODTl~FiNT
FIG. 1 shows a first embodiment of the invention. As shown, the guidewire, when ;nt~n~Pd for percutaneous transluminal coronary angioplasty may be approximately 175 cm to 300 cm in total length and_includes an elongated rotationally rigid, longitudinally flexible core wire 10, preferably made of stainle3s steel or other material suitable for use as a guidewire shaft. The majority of the length ~approximately 148 cm to 273 cm) is in the proximal segment ll of the core wire which ha~ a substantially uniform diameter of approximately 0 . 25 to 0 . 457 mm (0.010 to 0.018 inches). The proximal segment 11 merges into a first tapered segment 12, about 3 cm long which, in turn, merges into an intermediate barrel segment 14, approximately 22 . 5 cm long and about 6 mils in diameter. Intermediate segment 14 merges into a second tapered segment 15, about 3 cm long which, in turn, merges into a distal barrel segment 16, about 2.5 cm long and approximately . 05 mm (2 mils) in diameter. The distal segment 16 is more f lexible than the intermediate segment 14 .
Alternatively, the core wire (from taper 12 to distal segment 16) may have a continuous taper along its length.
AMENDED SHEEr I PEA/EP
~ 2 ~ ~4484 so410/7227Wo A distal coil 18, approximately 3 cm in length, is supported about the distal segment of the core wire and preferably is attached at its proximal end to the core wire by adhesive at joint 20. Suitable adhesives include an ultraviolet curable adhesive or a cyanoacrylate adhesive. The joint 20 alternatively may be welded, soldered or brazed. The distal coil 18 is attached at its distal end to the core wire by a distal hemispherical tip weld 22. The distal coil may be formed from a highly radiopaque material such as a gold/platinum or platinum/tungsten alloy. In a guidewire intended for use in percutaneous transluminal coronary angioplasty, the diameter of the wire from which the distal coil 18 is wound preferably is within the range of 0 . 025-0 .102mm ( . 001- . 004 inches) . The outer diameter of the distal coil 18 preferably is within the range of 0.25 - 0.46 mm (.010-.018 inches).
A proximal coil 24 is 3upported about the intermediate segment 14 of the core wire and is preferably attached at its distal end to the core wire by adhesive at joint 26. The proximal end of coil 24 extend3 to the proximal end of the intermediate segment 14 of the core wire where it may be attached to the core wire by adhesive at joint 25. Joints 25 and 26 may alternatively be welded, soldered or brazed. The outer diameter of the proximal coil is preferably the same as that of the distal coil 18. The proximal coil preferably is 7-22 cm in length. The proximal coil 24 may be less radiopaque than the distal coil 18 or of equivalent radiopacity. The proximal coil preferably is formed from the same material a~ the distal coil but may be formed from smaller diameter wire to achieve the desired reduced radiopacity . AMENDED SHEFT
IPtAlEP
21 844~4 B0410t7227WO
g The region of the guidewire between the proximal and distal coils, inr]ll~;nJ a portion of the int~ te segment 14 and tapered segment 15, is covered by a f lexible polymeric sleeve 34 .
The sleeve, preferably having an outer diameter er~ual to that of the proximal and distal coils, provides a uniform outer ,1; i tPr to the distal region of the guidewire such that the catheter will -smoothly move over the guidewire during advi~nrpm~nt~ The sleeve preferably is flexible, kink resistant and includes a lubricious surface for aiding in guidewire maneuverability. The sleeve preferably is formed from a polymer material (such as polyamide or polyethrlene) which exhibits the above properties. A
hydrophilic or hydrophobic coating may be used to coat the outer surface of the polymer sleeve for added lubricity.
The sleeve preferably is as thin as is practical, depending on the polymer material from which the 81eeve iiY made, in order that the region of the sleeve displays a desired degree of flexibility. The wall thickness of the sleeve preferably falls within the range of 0.005 - 0.05 mm (.0002-.002 inches). The sleeve preferably covers the proximal end of the distal coil and the distal end of the proximal coil and may be 5-20 cm in length.
As shown in FIG. 1, the distal end of the proximal coil 24 and the proximal end of the distal coil 18 can be stretched and tapered down to a smaller diameter in the region where they are attached to the core wire and overlapped by the ends of the polymer sleeve 34. The polymer sleeve preferably is adhesively attached at both ends to the guidewire. If adhesively attached, a small gap 23 exists between the inner surface of the sleeve and outer surfaces of AMENDE~ SHEET
IPEA/EP
. _ , . , .. , .. , . . , _ . . .. .. .
2~8~484 so410/722~Wo /
the marker bands 28, 30 and 32 (discu3sed below). The size of the gap is approximately equal to 0 . 025mm ( . 001 inches) but would depend on the rh;~kn~qs of the sleeve wall and the outer diameter of the marker bands. The gap prevents the outer contour of the marker bands from projecting through the polymer sleeve.
Alternatively, the sleeve may be heat shrunk about the guidewire.
Radiopaque marker bands 28, 30 and 32 are attached to the core wire between the proximal and distal coils. Marker bands 28, 30 and 32 preferably are attached by adhesive at joints 36, 38 and 40, respectively. Alternatively, ;oints 36, 38 and 40 may be welded or brazed. The marker bands preferably are made from a radiopaque material such as tantalum, platinum, gold or alloys thereof. The marker bands will be spaced to provide optimum usability for various l n vivo dlmension measurements by a physician. Particularly, the spacing and dimensions of the marker bands provide ref erence lengths such that the length and shape of a lesion and adjacent arterial dimensions can be determined fluoroscopically. Such a determination can aid a physician in the selection of an appropriately sized balloon.
Additionally, if necessary, such a determilzation aids in the selection of an appropriately sized stent The marker bands also provide reference locations which can aid in placing a post-stent balloon after stent placement. While the guidewire preferably includes three marker bands, as shown and described, it is envisioned that as few as one marker band could be used.
AMENDE~D SHEET
IPEAIEP
WO 95/2.1237 ~ t ~ PCTrUSs~rO3076 ' The guidewire of the first embodiment thus has a distal tip section 16 that is highly radiopaque, an ;nt~rr^C~iate section (between the coils) that is non-radiopaque (except for the marker bands), and a proximal section that is moderately or highly radiopaque. Such an arrangement may be referred to as "grey/white/black" or "black/white/black"
~from the proximal to the distal ends), referring to its relative appearance under fluoroscopy. The highly radiopaque distal segment provides clear, Yisible, fluoroscopic indication of the distal tip of the guidewire to indicate clearly the guidewire position. Typically, the distal tip of the guidewire is advanced through and beyond the stenosis to be treated. The jn' -';ate, non--radiopague segment is intf~n~led to be disposed at the region of the stenosis so that the region will be ~ulob~L.Lcted by radiopague effects of the guidewire. Thus, the full radiopaque effect of the radiopa~ue contrast liquid injected into the artery can be visualized on the fluoroscope, particularly in the critical stenosed region of the artery. The moderately or highly radiopaque proximal segment provides an indication of the position and conf iguration of the more proximally located portions of the guidewire and, therefore, the proximal arterial anatomy.
The "grey/white/black" or "black/white/black"
configuration can be achieved with the appropriate relative degrees of radiopacity by varying the thicknesses of the wires from which the coils are wound, as described above.
Alternatively, as will be understood by those skilled in the art, the coils may be plated with varying thicknesses of radiopaque material to achieve the desired levels of SU~SrIME SHEET (RULE 26) wo ssl2~237 2 ~ 8 4 4 8 4 PCT/US9S/03076 , ~ " r t --12-- ~
radiopacity. The plating process is described in U . S . Patent No. 5,144,959 (Gambale), which is herein incorporated by reference in its entirety.
FIG. 2 illustrates a second embodiment of the invention which is fairly similar in construction to the first i . Like elements in FIG. 2 are referred to by identical reference characters ~to those in EIG. 1). In the embodiment of FIG. 2, the construction of the core wire 10, the distal coil 18, and the marker bands 28, 30 and 32 is identical to that of the first ' ~i L ~shown in FIG. 1).
The guidewire of the second embodiment, however, omits the proximal coil 24 of the first ~ . As in the first : ~o~; ~, a polymeric sleeve 34, having the same properties as those described above, encases the proximal end of the distal coil and the marker bands. In the second ' ~
however, sleeve 34 extends proximally of the marker bands to tapered segment 12 of core wire 10. The sleeve provides a uniform outer diameter to the distal region of the guidewire to aid in smooth advdllcG t of the catheter over the guidewire. The sleeve preferably is adhesively attached at both ends to the guidewire. Like the: ' of FIG. 1, if adhesively attached, a small gap 39 exists between the inner surface of the sleeve and the outer surface of the marker bands 28, 30 and 32. The gap prevents the outer contour of the marker bands from projecting through the polymer sleeve. Alternatively, the sleeve may be heat shrunk about the guidewire such that, proximally of the marker bands, the sleeve 34 tapers down to f it tightly around the int~r--~l; Ate segment 14 of core wire to create a smooth transition .
SU35r1TUTE SHEET (RULE 26) so410,/7227wo !
The guidewire of the second embodiment thus has a distal region including a distal tip section 16 that i8 highly radiopaque and a proximal section that is non-radiopaque. Such an arrangement is referred to as "white/black" (from the proximal to the distal ends), referring to its relative appearance under f luoroscopy As with the embodiment of FIG . 1, the highly radiopaque distal segment provides clear, visible fluoroscopic indication of the distal tip of the guidewire to indicate clearly the guidewire position and the proximal, non-radiopaque segment provides for unobstructed visualization of the stenosis.
FIG. 3 shows a third embodiment of the invention in which a radiopaque coil 50 is supported by and attached to a distal region of the core wire 51 Core wire 51 is an alternate embodiment core wire in which the distal barrel segment 16 of the core wire 10 of the first embodiment is absent and is replaced by a pair of round forming wires 53 and 55 which extend from tapered segment 15 to hemispherical tip weld 22 The forming wires, typically 3-7 cm in length, preferably are adhesively attached to tapered segment 15 and extend approximately 2 cm beyond the distal tip of core wire 51 ~he forming wires preferably are formed from materials such as stainless steel, Sandvik lRK91, PH455 or MP35~ Coil 50 can be used, however, with the core wire 10 of the first embodiment. Similarly, the guidewire constructions of the first and second embodiments can be used with the core wire 51 AMENDED SHEET
IPEA/EP
2 1 8~484 As shown in FIG. 3, the distal end of the coil 50 is attached to the hemispherical tip weld and the coil extends proximally to the tapered section 12 of the core wire. The proximal end of the coil 50 is attached to the core wire by adhesive at joint 52.
Alternatively, joint 52 may be soldered or brazed. Coil 50 may also be attached to the core wire, preferably by adhesive, near the distal end of the coil to add structural integrity to the distal end of the guidewire such that unwinding of the coil during adv~n~ ~mf~n~ of the guidewire through an artery i~
prevented. Spring 50 preferably is formed from a radiopaque material such as a platinum/gold or other suitable alloy. The diameter of the wire from which the coil 50 is wound preferably is within the range of 0.025 - p.10 mm (0.001-0.004 inches). The outer diameter of the coi1 preferably is within the range of o . 25 - 0.46 mm (.010-.018 inches). A typical coil length falls within the range of 5-20 cm. If using a coil having a length of 5 cm, the corresponding dimensions of the core wire would be less than that disclosed above, as will be appreciated by those skilled in the art.
Spring 50 has varying pitch along its length including multiple tightly wound coil sections separated by loosely wound coil sections. The tightly wound coil ~iections appear dark under fluoroscopy and the loosely wound coil sections appear light.
Among the tightly wound coil sections are a distal section 54, preferably within the range of 2-3 cm in length, and a proximal section 55, within the range of 3-10 cm in length. Thus, the proximal and distal sections are highly radiopaque.
AMENDED SHEET
~PEA/EP
wo 9sl2~237 , ~ PCTlUSsSI03076 ~ 2 1 ~4484 An intermediate section 57 of the coil may include multiple tightly wound coil sections 56; 58, 60, 62, and 64, and loosely wound coil sections 65, 66, 68, 70, 72, and 7~.
The iLlL ~-'i ate section as a whole appears light under fluoroscopy with the tightly wound sections appearing as dark markers, providing reference lengths and location markers for the physician. Markers 56, 58, 60 and 62 may be uniformly spaced, preferably in 1 cm to 2 cm multiples. The number of markers and the length and spacing thereof, however, can be changed to suit a particular application. It is envisioned, that as few as one marker band could be used.
The majority of the length of the spring, from a proximal point of the distal section to the proximal end of the spring, is covered by a f lexible polymeric sleeve 34 . Sleeve 34 exhibits the same ~ualities as the sleeve described above in connection with the f irst and second embodiments . The sleeve provides a uniform outer diameter to the distal region of the guidewire. The sleeve, therefore, helps to ensure smooth catheter ~ over the guidewire during advAn,~- L. Sleeve 34 preferably is adhesively attached to the guidewire at proximal 76 and distal 78 joints. If adhesively attached, a small gap 80 exists between the outer surface of spring 50 and the inner surface of sleeve 34. The gap enables free bending ~l ,t of the coils of spring 50 beneath the sleeve 34 while the guidewire is maneuvered through an artery. Additionally, the gap ~ v~ S the co~tour of the outer surface of the coils from projecting through the polymer sleeve 34. Alternatively, the ends of the sleeve 34 maybe heat shrunk about the guidewire. It should be unde~stood that the m-thod of attaching the sleeve to the SuaST~ME SHEET (RULE 26) ~,~'0 95121237 2 1 8 4 ~ 8 4 PCTIUS95/03076 3 1, guidewire only at its ends by adhesive or by heat shrirking its ends can be used with any of the guidewire embodiments disclosed herei~.
The guidewire of the third o-`~oAi ~ thus has a distal tip section and a proximal section that are highly radiopaque and an int: -~iate section that is lightly radiopaque (except for the darker markers). Such an arrangement is referred to as "black/grey/black" (from the proximal to the distal ends), referring to its relative appearance under fluoroscopy. As with the previously described ~ ts, the highly radiopaque distal segment provides clear, visible fluoroscopic indication of the distal tip of the guidewire to indicate clearly the guidewire position and the int e~ii ate, lightly radiopague segment provides for substantially unobstructed vis~ a~; on of the stenosis .
As described above, the proximal and distal sections of the coil preferably are equally highly radiopaque.
Alternatively, the distal section can be more radiopaque than the proximal section. To achieve the desired relative radiopacity, the distal section 54 of the coil may be wound from a wire having a greater diameter than that of the proximal sectio~. Alternatively, as will be understood by those skilled in the art, the distal section 54 may include another shorter radiopaque coil 90 which is supported by and attached to the extreme distal part of the core wire and which is located within the distal section of the coil, as shown in FIG. 4.
Referring to FIG. 4, inner coil 90 is attached at its distal end to the hemispherical tip weld 22 and may be attached at its proximal end to the forming wires 53 and 55 SUBSTITUTE SHEET (RULE 26) . O - 2i8'1~84 and the tapered segment 15, preferably by adhesive.
Alternatively, the proximal end of the inner coil may not be attached to any element. Be~ides inner coil 9o, the embodiment of FIG. 4 is identical to that of FIG. 3. The inner coil 90 preferably has an outer diameter within the range of 0.15 - 0.30 mm(.006-.012 inches~, a length within the range of 1-4 cm, and is made from a radiopaque material such as platinum, gold or a platinum/gold alloy. The diameter of the wire from which the inner coil is wound i5 preferably within the range of 0 . 025 -0 . 076 mm ( . 001 to 003 inches) . The inner coil 90 is surrounded by the distal section of the coil 50 such that the distal ~ection will appear highly radiopaque.
FIG. 5 shows a fourth embodiment of the invention in which the guidewire preferably falls within the range of 180-300 cm in length and includes an elongated rotationally rigid, longitudinally flexible core wire 10, preferably made of stainle~s ~teel. The majority of the length (preferably 110-280 cm) of the core wire is in the proximal portion 11 which has a substantially uniform diameter, typically within the range of 0.25 -~0.46 mm (10-18 mils) . The proximal portlon 11 merges into a first tapered segment 12, preferably 2-10 cm in length, which, in turn, merge~ into a first barrel segment 13, preferably 10-20 cm in length. The diameter of barrel segment 13 preferably is within the range of 0.13 - 0.30 mm (5-12 mils), less than that of proximal portion 11 First barrel segment 13 merges into a second tapered segment 17, preferably 2-6 cm in length, which, in turn, merges into a second barrel segment 19, preferably 5-15 cm in length. The diameter of barrel segment 19 preferably is within the range of 0.10 - 0.25 mm(4-10 mils), less than that of AMENDEI~ EET
IPEA~'EP
~ - 2 1 84484 f irst barrel segment 13 . Barrel segment 19 merges into a third tapered segment 21, preferably 2-10 cm in length, which extends to the distal end of the core wire.
One or more forming wires (only one of the forming wires 53 is shown) extend from tapered segment 21 to a rounded tip weld 22. The forming wires, typically one to five cm in length, preferably are adhesively attached to tapered segment 21 at joint 78 and extend approximately 2 cm beyond the distal tip of core wire 10. Alternatively, joint 78 can be soldered or brazed. The forming wires preferably are made from a specially treated precipitation hardenable alloy material. One such material is an alloy of nickel, cobalt, molybdenum and chromium, colllmercially available from Fort Wayne Metals of Fort Wayne, Indiana under the trade designation MP35N. Another suitable material i8 a single stage martensitic precipitation hardenable stainless ~teel having modif ied proportions of chromium and nickel and with additional elements of copper and titanium, commercially available f rom Carpenter Steel Co. of Reading, Pennsylvania under the trade designation 455PH. Still another suitable material i~ a precipitation hardenable alloy that is commercially available from Sandvik Steel under the trade designation Sandvik lRKgl.
While the distal region 27 of the core wire has been shown and described herein as including two tapered segments, two barrel segments and two forming wires, it should be understood that other core wires can be used with this fourth embodiment such as, for example, a core wire that has a distal region including only a single barrel segment which merges into a tapered segment that extends to the distal end AMENDED SHEET
IPEA/EP
. ~ ` t~
- 2 ~ ~4484 sO410/7227WO
of the core wire (with or without forming wires). Any of the guidewire embodiments disclosed herein can be practiced with a core wire having a distal region that either includes one or more forming wires or, alternatively, a core wire that extends to the distal tip of the guidewire.
A radiopaque coil 50 is supported by and attached to the distal region 27 of the core wire 10. The distal end of the coil 50 is attached by the hemispherical tip weld. Just proximally of the distal end of coil 50, the coil is attached to the core wire at joint 78. Joint 78 also adds integrity to the structure of the distal end of the guidewire to prevent the coil 50 from separating from the core Mire if the forming wires break during use. The coil extends proximally to the tapered sectipn 12 o the core wire lO. The proximal end of the coil is attached to the corc wire by adhesive at joint 52. Alternatively, joint 52 can be soldered or brazed. Spring 50 preferably is formed from a radiopaque material such as platinum/gold or other suitable alloy. The diameter of the wire from which the coil is wound preferably is within the range of 0 . 038 - 0 . 076 mm ( . 0015 - . 003 inches). The outer diameter of the coil preferably is within the range of 0 . 25 - 0 . 45 mm ( . 010 - . 018 inches) . A typical coil length falls within the range of 15-40 cm. While the coil is shown in FIG. S as having an outer diameter that is less than that of the proximal portion 11 of the core wire, it is to be appreciated that the outer diameter of the coil is preferably equal to or approximately equal to the outer diameter of the proximal portion 11 of the core wire.
Al~AENDED SHEET
IPEA/EP
wo g~/2~237 PCr~'S9~/03076 t -~
~ 21 ~4484 Spring 50 has varying pitch along its length including distal and proximal tightly wound coil sections 54 and 55 separated by an intermediate loosely wound window coil section 57. The tightly wound coil sections appear dark under fluoroscopy and the loosely wound window coil section appears light. Distal section 54 preferably falls within the range of one to five cm in length, proximal section 55 preferably falls within the range o 10--25 cm in length, and -~iiate window section 57 preferably falls within the range of 5-20 cm in length.
Tntl -~iate window section 57 may include a number of short tightly wound coil sections (not shown) separated by loosely wound coil sections as in the embodiment of FIG. 3.
The tightly wound sections appear as dark marlcers under fluoroscopy for providing reference lengths and location marks for a physician. The number of markers and the length and spacing thereof can be selected to suit a particular application .
T L ~iate window section 57 of the coil 50 is covered by a flexible polymeric sleeve 81. The sleeve 81 is kink resistant and includes a lubricious surface for aiding in guidewire maneuverability. The sleeve preferably is formed from polyethylene terephthalate (PET) but may be formed from other thermoplastic polymers such as polyethelene. A
hydrophilic or hydrophobic coating may be used to coat the outer surface of the guidewire including the polymer sleeve for added lubricity.
The sleeve preferably is as thin as is practical, depending on the polymer material from which the sleeve is made, in order that the region of the sleeve displays a SUBSTITUTE SHEET (RUI.E 26~
~ - - 2 ~ 84~4 so410/7227Wo desired degree of flexibility. The wall thickness of the sleeve preferably falls within the range of 0.005 - 0.05 mm (.0002-.002 inches). The sleeve 81 is attached to the guidewire only at its proximal and distal ends 82 and 84 leach preferably within the range oi 0.5-2 cm in length) by heat shrinking the sleeve only at those ends. Only the ends 82 and 84 of the sleeve 81 are respectively heat shrunk about the tightly wound coils of the proximal 55 and distal 54 regions immediately adjacent the window section 57.
A small gap 80 exists between the outer surface of the intermediate section 57 of coil 50 and the inner surface of sleeve 81. The size of the gap is approximately equal to . 0001 inches but would depend on the thickness of the sleeve wall and the outer diameter of the spring. The gap prevents the contour of the outer surface of the coils from projecting through the sleeve and contacting the inner arterial wall (which would occur if the sleeve were heat shrunk about the entire length of the coil) so that the guidewire can be navigated smoothly through the artery during use. Additionally, the sleeve 81 insulates the loosely wound coils of the intermediate section 57 from the inner arterial wall to prevent them from significant m.,v t relative to one another during advancement through an artery. Such movement could result in altering the fluoroscopic image of the guidewire and/or altering the structure and functionality of the coils of the spring.
The distal region of the fourth embodiment (FIG 5) of the guidewire thus has distal tip and proximal sections that are highly radiopaque and an intermediate section that is lightly radiopaque- Such an Alr\~Eln~Dem-eDn~ EErTeferred to as IPEA/EP
wo 9512 1237 ~ PCTIUS95103076 ' `i 21~4484 "black/grey/black" (from the proximal section to the distal end), referring to its relative appearance under fluoroscopy. The highly radiopaque distal segment provides clear, visible fluoroscopic indication of the distal tip of the guidewire to indicate clearly the guidewire position, Typically, the distal tip of the guidewire is advanced through and beyond the stenosis to be treated. The ;ate, lightly radiopaque segment is inr~n~ tl to be disposed at the region of the stenosis so that the region will not be materially obstructed by radiopaque effects of the guidewire. Thus, the full radiopaque effect of the radiopaque contrast liquid injected into the artery can be visuali~ed on the fluoroscope, particularly in the critical stenosed region of the artery. The radiopaque proximal segment provides an irldication of the position and configuration of the more proximally located portions of the guidewire and, therefore, the proximal arterial anatomy, so that a physician can observe the more proximally located portions of the guidewire.
The proximal and distal sections of the coil preferably are equally highly radiopaque. Alternatively, the distal section can be more radiopaque than the proximal section. To achieve the desired relative radiopacity, the distal section 54 of the coil may be plated with a radiopaque material.
The guidewire of the present inventio~ provides a number of advantages. The guidewire facilitates better lesi~n asse~ both by providing a non-obstructing region that does not impair fluoroscopic evaluation of the shape of the lesion and by providing a radiopaque proximal section that allows visualization of the proximal portion of the wire. It SUBSrlTUTE SHEET (RULE 26) wo g~/2~237 ~ ;, PCT/US~/03076 ; ~ 2 1 ~ 4 4 8 4 ' also provides radiopaque markers which offer a simple means by which the physician can determine the length of the lesion, adjacent arterial dimensions, and/or reference lesion or stent location. Selection of an appropriately sized balloon and, i necessary, selection of an appropriate stent is, therefore, facilitated. Additionally, the sleeve provides a uniform outer diameter to the distal region of the guidewire to ensure smooth r,l~ v~ t of the catheter during advancement. Also, as in the fourth embodiment, by heat shrinking the sleeve only at its ends, the outer contour of the coils is prevented from projecting through the sleeve, and the sleeve insulates the loosely wound coils from the inner arterial wall, preventing them from substantial relative r ~ L.
Thus, we have described a guidewire having varied degrees of radiopacity whereby, a distal section of the distal region of the guidewire appears dark under fluoroscopy and an jnt~ -aiate section o~ the distal region appears generally white (or light in an alternate: ' -'; t). At least one radiopaque marker may be located in the int, 'iate section for providing rèference lengths and location marks for a physician. A polymer sleeve encases at least part of the distal region, providing a uniform outer diameter to the region (in some: ' li tS), to aid in smooth catheter advAn. ~. It should be understood, however, that the foregoing description of the invention is ;nt~n~ ad merely to be illustrative thereof and that other embo~ai and modifications may be apparent to those skilled in the art without departing from its objects, purposes and spirit.
Having thus described the invention, what we desire to claim is:
SUBSrlTUTE SHt~T (RULE 26)
the marker bands 28, 30 and 32 (discu3sed below). The size of the gap is approximately equal to 0 . 025mm ( . 001 inches) but would depend on the rh;~kn~qs of the sleeve wall and the outer diameter of the marker bands. The gap prevents the outer contour of the marker bands from projecting through the polymer sleeve.
Alternatively, the sleeve may be heat shrunk about the guidewire.
Radiopaque marker bands 28, 30 and 32 are attached to the core wire between the proximal and distal coils. Marker bands 28, 30 and 32 preferably are attached by adhesive at joints 36, 38 and 40, respectively. Alternatively, ;oints 36, 38 and 40 may be welded or brazed. The marker bands preferably are made from a radiopaque material such as tantalum, platinum, gold or alloys thereof. The marker bands will be spaced to provide optimum usability for various l n vivo dlmension measurements by a physician. Particularly, the spacing and dimensions of the marker bands provide ref erence lengths such that the length and shape of a lesion and adjacent arterial dimensions can be determined fluoroscopically. Such a determination can aid a physician in the selection of an appropriately sized balloon.
Additionally, if necessary, such a determilzation aids in the selection of an appropriately sized stent The marker bands also provide reference locations which can aid in placing a post-stent balloon after stent placement. While the guidewire preferably includes three marker bands, as shown and described, it is envisioned that as few as one marker band could be used.
AMENDE~D SHEET
IPEAIEP
WO 95/2.1237 ~ t ~ PCTrUSs~rO3076 ' The guidewire of the first embodiment thus has a distal tip section 16 that is highly radiopaque, an ;nt~rr^C~iate section (between the coils) that is non-radiopaque (except for the marker bands), and a proximal section that is moderately or highly radiopaque. Such an arrangement may be referred to as "grey/white/black" or "black/white/black"
~from the proximal to the distal ends), referring to its relative appearance under fluoroscopy. The highly radiopaque distal segment provides clear, Yisible, fluoroscopic indication of the distal tip of the guidewire to indicate clearly the guidewire position. Typically, the distal tip of the guidewire is advanced through and beyond the stenosis to be treated. The jn' -';ate, non--radiopague segment is intf~n~led to be disposed at the region of the stenosis so that the region will be ~ulob~L.Lcted by radiopague effects of the guidewire. Thus, the full radiopaque effect of the radiopa~ue contrast liquid injected into the artery can be visualized on the fluoroscope, particularly in the critical stenosed region of the artery. The moderately or highly radiopaque proximal segment provides an indication of the position and conf iguration of the more proximally located portions of the guidewire and, therefore, the proximal arterial anatomy.
The "grey/white/black" or "black/white/black"
configuration can be achieved with the appropriate relative degrees of radiopacity by varying the thicknesses of the wires from which the coils are wound, as described above.
Alternatively, as will be understood by those skilled in the art, the coils may be plated with varying thicknesses of radiopaque material to achieve the desired levels of SU~SrIME SHEET (RULE 26) wo ssl2~237 2 ~ 8 4 4 8 4 PCT/US9S/03076 , ~ " r t --12-- ~
radiopacity. The plating process is described in U . S . Patent No. 5,144,959 (Gambale), which is herein incorporated by reference in its entirety.
FIG. 2 illustrates a second embodiment of the invention which is fairly similar in construction to the first i . Like elements in FIG. 2 are referred to by identical reference characters ~to those in EIG. 1). In the embodiment of FIG. 2, the construction of the core wire 10, the distal coil 18, and the marker bands 28, 30 and 32 is identical to that of the first ' ~i L ~shown in FIG. 1).
The guidewire of the second embodiment, however, omits the proximal coil 24 of the first ~ . As in the first : ~o~; ~, a polymeric sleeve 34, having the same properties as those described above, encases the proximal end of the distal coil and the marker bands. In the second ' ~
however, sleeve 34 extends proximally of the marker bands to tapered segment 12 of core wire 10. The sleeve provides a uniform outer diameter to the distal region of the guidewire to aid in smooth advdllcG t of the catheter over the guidewire. The sleeve preferably is adhesively attached at both ends to the guidewire. Like the: ' of FIG. 1, if adhesively attached, a small gap 39 exists between the inner surface of the sleeve and the outer surface of the marker bands 28, 30 and 32. The gap prevents the outer contour of the marker bands from projecting through the polymer sleeve. Alternatively, the sleeve may be heat shrunk about the guidewire such that, proximally of the marker bands, the sleeve 34 tapers down to f it tightly around the int~r--~l; Ate segment 14 of core wire to create a smooth transition .
SU35r1TUTE SHEET (RULE 26) so410,/7227wo !
The guidewire of the second embodiment thus has a distal region including a distal tip section 16 that i8 highly radiopaque and a proximal section that is non-radiopaque. Such an arrangement is referred to as "white/black" (from the proximal to the distal ends), referring to its relative appearance under f luoroscopy As with the embodiment of FIG . 1, the highly radiopaque distal segment provides clear, visible fluoroscopic indication of the distal tip of the guidewire to indicate clearly the guidewire position and the proximal, non-radiopaque segment provides for unobstructed visualization of the stenosis.
FIG. 3 shows a third embodiment of the invention in which a radiopaque coil 50 is supported by and attached to a distal region of the core wire 51 Core wire 51 is an alternate embodiment core wire in which the distal barrel segment 16 of the core wire 10 of the first embodiment is absent and is replaced by a pair of round forming wires 53 and 55 which extend from tapered segment 15 to hemispherical tip weld 22 The forming wires, typically 3-7 cm in length, preferably are adhesively attached to tapered segment 15 and extend approximately 2 cm beyond the distal tip of core wire 51 ~he forming wires preferably are formed from materials such as stainless steel, Sandvik lRK91, PH455 or MP35~ Coil 50 can be used, however, with the core wire 10 of the first embodiment. Similarly, the guidewire constructions of the first and second embodiments can be used with the core wire 51 AMENDED SHEET
IPEA/EP
2 1 8~484 As shown in FIG. 3, the distal end of the coil 50 is attached to the hemispherical tip weld and the coil extends proximally to the tapered section 12 of the core wire. The proximal end of the coil 50 is attached to the core wire by adhesive at joint 52.
Alternatively, joint 52 may be soldered or brazed. Coil 50 may also be attached to the core wire, preferably by adhesive, near the distal end of the coil to add structural integrity to the distal end of the guidewire such that unwinding of the coil during adv~n~ ~mf~n~ of the guidewire through an artery i~
prevented. Spring 50 preferably is formed from a radiopaque material such as a platinum/gold or other suitable alloy. The diameter of the wire from which the coil 50 is wound preferably is within the range of 0.025 - p.10 mm (0.001-0.004 inches). The outer diameter of the coi1 preferably is within the range of o . 25 - 0.46 mm (.010-.018 inches). A typical coil length falls within the range of 5-20 cm. If using a coil having a length of 5 cm, the corresponding dimensions of the core wire would be less than that disclosed above, as will be appreciated by those skilled in the art.
Spring 50 has varying pitch along its length including multiple tightly wound coil sections separated by loosely wound coil sections. The tightly wound coil ~iections appear dark under fluoroscopy and the loosely wound coil sections appear light.
Among the tightly wound coil sections are a distal section 54, preferably within the range of 2-3 cm in length, and a proximal section 55, within the range of 3-10 cm in length. Thus, the proximal and distal sections are highly radiopaque.
AMENDED SHEET
~PEA/EP
wo 9sl2~237 , ~ PCTlUSsSI03076 ~ 2 1 ~4484 An intermediate section 57 of the coil may include multiple tightly wound coil sections 56; 58, 60, 62, and 64, and loosely wound coil sections 65, 66, 68, 70, 72, and 7~.
The iLlL ~-'i ate section as a whole appears light under fluoroscopy with the tightly wound sections appearing as dark markers, providing reference lengths and location markers for the physician. Markers 56, 58, 60 and 62 may be uniformly spaced, preferably in 1 cm to 2 cm multiples. The number of markers and the length and spacing thereof, however, can be changed to suit a particular application. It is envisioned, that as few as one marker band could be used.
The majority of the length of the spring, from a proximal point of the distal section to the proximal end of the spring, is covered by a f lexible polymeric sleeve 34 . Sleeve 34 exhibits the same ~ualities as the sleeve described above in connection with the f irst and second embodiments . The sleeve provides a uniform outer diameter to the distal region of the guidewire. The sleeve, therefore, helps to ensure smooth catheter ~ over the guidewire during advAn,~- L. Sleeve 34 preferably is adhesively attached to the guidewire at proximal 76 and distal 78 joints. If adhesively attached, a small gap 80 exists between the outer surface of spring 50 and the inner surface of sleeve 34. The gap enables free bending ~l ,t of the coils of spring 50 beneath the sleeve 34 while the guidewire is maneuvered through an artery. Additionally, the gap ~ v~ S the co~tour of the outer surface of the coils from projecting through the polymer sleeve 34. Alternatively, the ends of the sleeve 34 maybe heat shrunk about the guidewire. It should be unde~stood that the m-thod of attaching the sleeve to the SuaST~ME SHEET (RULE 26) ~,~'0 95121237 2 1 8 4 ~ 8 4 PCTIUS95/03076 3 1, guidewire only at its ends by adhesive or by heat shrirking its ends can be used with any of the guidewire embodiments disclosed herei~.
The guidewire of the third o-`~oAi ~ thus has a distal tip section and a proximal section that are highly radiopaque and an int: -~iate section that is lightly radiopaque (except for the darker markers). Such an arrangement is referred to as "black/grey/black" (from the proximal to the distal ends), referring to its relative appearance under fluoroscopy. As with the previously described ~ ts, the highly radiopaque distal segment provides clear, visible fluoroscopic indication of the distal tip of the guidewire to indicate clearly the guidewire position and the int e~ii ate, lightly radiopague segment provides for substantially unobstructed vis~ a~; on of the stenosis .
As described above, the proximal and distal sections of the coil preferably are equally highly radiopaque.
Alternatively, the distal section can be more radiopaque than the proximal section. To achieve the desired relative radiopacity, the distal section 54 of the coil may be wound from a wire having a greater diameter than that of the proximal sectio~. Alternatively, as will be understood by those skilled in the art, the distal section 54 may include another shorter radiopaque coil 90 which is supported by and attached to the extreme distal part of the core wire and which is located within the distal section of the coil, as shown in FIG. 4.
Referring to FIG. 4, inner coil 90 is attached at its distal end to the hemispherical tip weld 22 and may be attached at its proximal end to the forming wires 53 and 55 SUBSTITUTE SHEET (RULE 26) . O - 2i8'1~84 and the tapered segment 15, preferably by adhesive.
Alternatively, the proximal end of the inner coil may not be attached to any element. Be~ides inner coil 9o, the embodiment of FIG. 4 is identical to that of FIG. 3. The inner coil 90 preferably has an outer diameter within the range of 0.15 - 0.30 mm(.006-.012 inches~, a length within the range of 1-4 cm, and is made from a radiopaque material such as platinum, gold or a platinum/gold alloy. The diameter of the wire from which the inner coil is wound i5 preferably within the range of 0 . 025 -0 . 076 mm ( . 001 to 003 inches) . The inner coil 90 is surrounded by the distal section of the coil 50 such that the distal ~ection will appear highly radiopaque.
FIG. 5 shows a fourth embodiment of the invention in which the guidewire preferably falls within the range of 180-300 cm in length and includes an elongated rotationally rigid, longitudinally flexible core wire 10, preferably made of stainle~s ~teel. The majority of the length (preferably 110-280 cm) of the core wire is in the proximal portion 11 which has a substantially uniform diameter, typically within the range of 0.25 -~0.46 mm (10-18 mils) . The proximal portlon 11 merges into a first tapered segment 12, preferably 2-10 cm in length, which, in turn, merge~ into a first barrel segment 13, preferably 10-20 cm in length. The diameter of barrel segment 13 preferably is within the range of 0.13 - 0.30 mm (5-12 mils), less than that of proximal portion 11 First barrel segment 13 merges into a second tapered segment 17, preferably 2-6 cm in length, which, in turn, merges into a second barrel segment 19, preferably 5-15 cm in length. The diameter of barrel segment 19 preferably is within the range of 0.10 - 0.25 mm(4-10 mils), less than that of AMENDEI~ EET
IPEA~'EP
~ - 2 1 84484 f irst barrel segment 13 . Barrel segment 19 merges into a third tapered segment 21, preferably 2-10 cm in length, which extends to the distal end of the core wire.
One or more forming wires (only one of the forming wires 53 is shown) extend from tapered segment 21 to a rounded tip weld 22. The forming wires, typically one to five cm in length, preferably are adhesively attached to tapered segment 21 at joint 78 and extend approximately 2 cm beyond the distal tip of core wire 10. Alternatively, joint 78 can be soldered or brazed. The forming wires preferably are made from a specially treated precipitation hardenable alloy material. One such material is an alloy of nickel, cobalt, molybdenum and chromium, colllmercially available from Fort Wayne Metals of Fort Wayne, Indiana under the trade designation MP35N. Another suitable material i8 a single stage martensitic precipitation hardenable stainless ~teel having modif ied proportions of chromium and nickel and with additional elements of copper and titanium, commercially available f rom Carpenter Steel Co. of Reading, Pennsylvania under the trade designation 455PH. Still another suitable material i~ a precipitation hardenable alloy that is commercially available from Sandvik Steel under the trade designation Sandvik lRKgl.
While the distal region 27 of the core wire has been shown and described herein as including two tapered segments, two barrel segments and two forming wires, it should be understood that other core wires can be used with this fourth embodiment such as, for example, a core wire that has a distal region including only a single barrel segment which merges into a tapered segment that extends to the distal end AMENDED SHEET
IPEA/EP
. ~ ` t~
- 2 ~ ~4484 sO410/7227WO
of the core wire (with or without forming wires). Any of the guidewire embodiments disclosed herein can be practiced with a core wire having a distal region that either includes one or more forming wires or, alternatively, a core wire that extends to the distal tip of the guidewire.
A radiopaque coil 50 is supported by and attached to the distal region 27 of the core wire 10. The distal end of the coil 50 is attached by the hemispherical tip weld. Just proximally of the distal end of coil 50, the coil is attached to the core wire at joint 78. Joint 78 also adds integrity to the structure of the distal end of the guidewire to prevent the coil 50 from separating from the core Mire if the forming wires break during use. The coil extends proximally to the tapered sectipn 12 o the core wire lO. The proximal end of the coil is attached to the corc wire by adhesive at joint 52. Alternatively, joint 52 can be soldered or brazed. Spring 50 preferably is formed from a radiopaque material such as platinum/gold or other suitable alloy. The diameter of the wire from which the coil is wound preferably is within the range of 0 . 038 - 0 . 076 mm ( . 0015 - . 003 inches). The outer diameter of the coil preferably is within the range of 0 . 25 - 0 . 45 mm ( . 010 - . 018 inches) . A typical coil length falls within the range of 15-40 cm. While the coil is shown in FIG. S as having an outer diameter that is less than that of the proximal portion 11 of the core wire, it is to be appreciated that the outer diameter of the coil is preferably equal to or approximately equal to the outer diameter of the proximal portion 11 of the core wire.
Al~AENDED SHEET
IPEA/EP
wo g~/2~237 PCr~'S9~/03076 t -~
~ 21 ~4484 Spring 50 has varying pitch along its length including distal and proximal tightly wound coil sections 54 and 55 separated by an intermediate loosely wound window coil section 57. The tightly wound coil sections appear dark under fluoroscopy and the loosely wound window coil section appears light. Distal section 54 preferably falls within the range of one to five cm in length, proximal section 55 preferably falls within the range o 10--25 cm in length, and -~iiate window section 57 preferably falls within the range of 5-20 cm in length.
Tntl -~iate window section 57 may include a number of short tightly wound coil sections (not shown) separated by loosely wound coil sections as in the embodiment of FIG. 3.
The tightly wound sections appear as dark marlcers under fluoroscopy for providing reference lengths and location marks for a physician. The number of markers and the length and spacing thereof can be selected to suit a particular application .
T L ~iate window section 57 of the coil 50 is covered by a flexible polymeric sleeve 81. The sleeve 81 is kink resistant and includes a lubricious surface for aiding in guidewire maneuverability. The sleeve preferably is formed from polyethylene terephthalate (PET) but may be formed from other thermoplastic polymers such as polyethelene. A
hydrophilic or hydrophobic coating may be used to coat the outer surface of the guidewire including the polymer sleeve for added lubricity.
The sleeve preferably is as thin as is practical, depending on the polymer material from which the sleeve is made, in order that the region of the sleeve displays a SUBSTITUTE SHEET (RUI.E 26~
~ - - 2 ~ 84~4 so410/7227Wo desired degree of flexibility. The wall thickness of the sleeve preferably falls within the range of 0.005 - 0.05 mm (.0002-.002 inches). The sleeve 81 is attached to the guidewire only at its proximal and distal ends 82 and 84 leach preferably within the range oi 0.5-2 cm in length) by heat shrinking the sleeve only at those ends. Only the ends 82 and 84 of the sleeve 81 are respectively heat shrunk about the tightly wound coils of the proximal 55 and distal 54 regions immediately adjacent the window section 57.
A small gap 80 exists between the outer surface of the intermediate section 57 of coil 50 and the inner surface of sleeve 81. The size of the gap is approximately equal to . 0001 inches but would depend on the thickness of the sleeve wall and the outer diameter of the spring. The gap prevents the contour of the outer surface of the coils from projecting through the sleeve and contacting the inner arterial wall (which would occur if the sleeve were heat shrunk about the entire length of the coil) so that the guidewire can be navigated smoothly through the artery during use. Additionally, the sleeve 81 insulates the loosely wound coils of the intermediate section 57 from the inner arterial wall to prevent them from significant m.,v t relative to one another during advancement through an artery. Such movement could result in altering the fluoroscopic image of the guidewire and/or altering the structure and functionality of the coils of the spring.
The distal region of the fourth embodiment (FIG 5) of the guidewire thus has distal tip and proximal sections that are highly radiopaque and an intermediate section that is lightly radiopaque- Such an Alr\~Eln~Dem-eDn~ EErTeferred to as IPEA/EP
wo 9512 1237 ~ PCTIUS95103076 ' `i 21~4484 "black/grey/black" (from the proximal section to the distal end), referring to its relative appearance under fluoroscopy. The highly radiopaque distal segment provides clear, visible fluoroscopic indication of the distal tip of the guidewire to indicate clearly the guidewire position, Typically, the distal tip of the guidewire is advanced through and beyond the stenosis to be treated. The ;ate, lightly radiopaque segment is inr~n~ tl to be disposed at the region of the stenosis so that the region will not be materially obstructed by radiopaque effects of the guidewire. Thus, the full radiopaque effect of the radiopaque contrast liquid injected into the artery can be visuali~ed on the fluoroscope, particularly in the critical stenosed region of the artery. The radiopaque proximal segment provides an irldication of the position and configuration of the more proximally located portions of the guidewire and, therefore, the proximal arterial anatomy, so that a physician can observe the more proximally located portions of the guidewire.
The proximal and distal sections of the coil preferably are equally highly radiopaque. Alternatively, the distal section can be more radiopaque than the proximal section. To achieve the desired relative radiopacity, the distal section 54 of the coil may be plated with a radiopaque material.
The guidewire of the present inventio~ provides a number of advantages. The guidewire facilitates better lesi~n asse~ both by providing a non-obstructing region that does not impair fluoroscopic evaluation of the shape of the lesion and by providing a radiopaque proximal section that allows visualization of the proximal portion of the wire. It SUBSrlTUTE SHEET (RULE 26) wo g~/2~237 ~ ;, PCT/US~/03076 ; ~ 2 1 ~ 4 4 8 4 ' also provides radiopaque markers which offer a simple means by which the physician can determine the length of the lesion, adjacent arterial dimensions, and/or reference lesion or stent location. Selection of an appropriately sized balloon and, i necessary, selection of an appropriate stent is, therefore, facilitated. Additionally, the sleeve provides a uniform outer diameter to the distal region of the guidewire to ensure smooth r,l~ v~ t of the catheter during advancement. Also, as in the fourth embodiment, by heat shrinking the sleeve only at its ends, the outer contour of the coils is prevented from projecting through the sleeve, and the sleeve insulates the loosely wound coils from the inner arterial wall, preventing them from substantial relative r ~ L.
Thus, we have described a guidewire having varied degrees of radiopacity whereby, a distal section of the distal region of the guidewire appears dark under fluoroscopy and an jnt~ -aiate section o~ the distal region appears generally white (or light in an alternate: ' -'; t). At least one radiopaque marker may be located in the int, 'iate section for providing rèference lengths and location marks for a physician. A polymer sleeve encases at least part of the distal region, providing a uniform outer diameter to the region (in some: ' li tS), to aid in smooth catheter advAn. ~. It should be understood, however, that the foregoing description of the invention is ;nt~n~ ad merely to be illustrative thereof and that other embo~ai and modifications may be apparent to those skilled in the art without departing from its objects, purposes and spirit.
Having thus described the invention, what we desire to claim is:
SUBSrlTUTE SHt~T (RULE 26)
Claims (23)
1. A medical guidewire having an elongate flexible shaft (10); a distal radiopaque coil (18) supported about and attached to a distal portion of the shaft (15); a proximal radiopaque coil (24) supported about and attached to an intermediate portion (14) of the shaft, the proximal coil being spaced from the distal coil; a polymer sleeve (34) encasing the shaft between the proximal and distal coils and at least a portion of the proximal and distal coils characterized by at least one radiopaque marker (28, 30, 32) attached to the shaft between the distal and proximal coils, the at least one marker being encased by the polymer sleeve and the space between the coils being less radiopaque than the coils and the at least one marker.
2. A medical guidewire as defined in claim 1, further characterized in that the polymer sleeve (34) encases a proximal region of the distal coil and a distal region of the proximal coil (24).
3. A medical guidewire as set forth in claim 1 further characterized by the at least one radiopaque marker (28, 30, 32) being attached to the shaft (14).
4. A medical guidewire as set forth in claim 1 further characterized by the at least one marker (28, 30, 32) including at least one radiopaque marker band attached to the shaft (14).
5. A medical guidewire as set forth in claim 1 further characterized in that the distal coil (18) is more radiopaque than the proximal coil (24) such that the distal coil will appear darker than the proximal coil under fluoroscopy.
6. A medical guidewire as set forth in claim 5 further characterized in that the wire from which the distal coil (18) is wound has a greater diameter than the wire from which the proximal coil (24) is wound.
7. A medical guidewire as set forth in claim 1 further characterized in that the radiopacity of the distal coil (18) is approximately equal to the radiopacity of the proximal coil (24) such that both coils will appear equally dark under fluoroscopy.
8. A medical guidewire having an elongate flexible shaft (10); a radiopaque coil (18) supported by and attached to a distal portion of the shaft (15) further characterized by at least one radiopaque marker (28, 30 ,32) attached to an intermediate portion of the shaft (14), proximally to the coil (18); and a polymer sleeve (34) attached to the shaft and encasing the at least one marker such that a gap (39) exists between the at least one marker and the sleeve.
9. A medical guidewire as set forth in claim 8 further characterized by the at least one marker (28, 30 ,32) including at least one marker band (28, 30 ,32) attached to the shaft (14).
10. A medical guidewire as set forth in claim 9 further characterized by the polymer sleeve also encasing the shaft (14) proximally to the at least one marker band (28, 30 ,32).
11. A medical guidewire as set forth in claim 10 further characterized by the polymer sleeve (24) also encasing the proximal end of the coil (18).
12. A medical guidewire comprising an elongate flexible shaft (10) and a first radiopaque coil (50) supported by and attached to a distal region of the shaft (10) further characterized by the first coil having highly radiopaque distal and proximal sections (54, 55) and more moderately radiopaque intermediate section (57), the intermediate section of the first coil including at least one tightly wound coil section (64) separated from the distal and proximal sections by loosely wound coil sections (74); and a polymer sleeve (34) attached to the shaft (12) and encasing the first coil along a majority of the length of the coil such that a gap (80) exists between the sleeve and the coil.
13. A medical guidewire as set forth in claim 11 further characterized by a second radiopaque coil 90 supported by the distal region of the shaft (15), wherein the distal section of the first coil (54) surrounds the second coil (90).
14. A medical guidewire having an elongated, flexible shaft (10) having a proximal region and a distal region; a helical coil (50) mounted to and disposed about the distal region of the shaft and at least a segment (74) of the helical coil being loosely wound further characterized by a flexible polymeric sleeve (34) covering at least that segment of the coil that is loosely wound;
the sleeve being attached to the guidewire both proximally and distally of the loosely wound coil segment, the sleeve being dimensioned with respect to the coil to define an annular gap (80) between an outer surface of the coil and an inner surface of the sleeve.
the sleeve being attached to the guidewire both proximally and distally of the loosely wound coil segment, the sleeve being dimensioned with respect to the coil to define an annular gap (80) between an outer surface of the coil and an inner surface of the sleeve.
15. A medical guidewire as defined in claim 14 further characterized by the regions of the sleeve (34) that are attached to the guidewire being attached adhesively.
16. A medical guidewire as defined in claim 14 further characterized by the ends of the sleeve (34) being heat shrunk about the guidewire.
17. A medical guidewire as defined in any one of claims 14-16 further characterized by at least one radiopaque marker (62) defined along the loosely wound segment of the coil.
18. A medical guidewire having an elongated, flexible shaft (10) having a proximal region and a distal region, a helical coil (50) mounted to and disposed about the distal region of the shaft and at least a segment (57) of the helical coil being loosely wound further characterized by a flexible polymeric sleeve (81) covering at least that segment of the coil that is loosely wound;
the sleeve being attached to the guidewire only at its ends (82, 84) both proximally and distally of the loosely wound coil segment.
the sleeve being attached to the guidewire only at its ends (82, 84) both proximally and distally of the loosely wound coil segment.
19. A medical guidewire as defined in claim 18 further characterized by the helical coil (50) including tightly wound proximal (55) and distal (54) coil sections and wherein the sleeve (81) is attached only to a distal end of the proximal tightly wound coil section and a proximal end of the distal tightly wound coil section.
20. A medical guidewire as defined in either of claims 18 or 19 further characterized by the sleeve (81) being heat shrinkable and the sleeve is heat shrunk only at its ends (82, 84) to the guidewire.
21. A medical guidewire having an elongated, flexible shaft (10) having a proximal region and a distal region, a helical coil (50) mounted to and disposed about the distal region of the shaft and at least a segment (57) of the helical coil being loosely wound; further characterized by a flexible polymeric sleeve (81) covering at least that segment of the coil that is loosely wound, the sleeve being loosely disposed about the loosely wound segment of the coil, the sleeve being attached only at its end (82, 84) to the guidewire.
22. A medical guidewire as set forth in claim 1 further characterized by the at least one marker being a plurality of markers (28, 30, 32) having predetermined spacing.
23. A medical guidewire as set forth in claim 1 further characterized by the at least one marker being a plurality of markers (28, 30, 32) having equal spacing.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US21255894A | 1994-03-11 | 1994-03-11 | |
US08/212,558 | 1994-03-11 | ||
US08/383,322 | 1995-02-03 | ||
US08/383,322 US5606981A (en) | 1994-03-11 | 1995-02-03 | Catheter guidewire with radiopaque markers |
Publications (1)
Publication Number | Publication Date |
---|---|
CA2184484A1 true CA2184484A1 (en) | 1995-09-14 |
Family
ID=26907255
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002184484A Abandoned CA2184484A1 (en) | 1994-03-11 | 1995-03-09 | Catheter guidewire with radiopaque markers |
Country Status (6)
Country | Link |
---|---|
US (1) | US5606981A (en) |
EP (1) | EP0749334B2 (en) |
JP (1) | JPH09510125A (en) |
CA (1) | CA2184484A1 (en) |
DE (1) | DE69517518T3 (en) |
WO (1) | WO1995024237A2 (en) |
Families Citing this family (130)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7033325B1 (en) | 1989-12-19 | 2006-04-25 | Scimed Life Systems, Inc. | Guidewire with multiple radiopaque marker sections |
ATE140159T1 (en) * | 1993-05-19 | 1996-07-15 | Schneider Europ Ag | GUIDE WIRE |
US6673025B1 (en) | 1993-12-01 | 2004-01-06 | Advanced Cardiovascular Systems, Inc. | Polymer coated guidewire |
US6245068B1 (en) | 1994-08-08 | 2001-06-12 | Scimed Life Systems, Inc. | Resilient radiopaque electrophysiology electrodes and probes including the same |
ATE193834T1 (en) * | 1995-03-02 | 2000-06-15 | Schneider Europ Gmbh | METHOD FOR PRODUCING A GUIDE WIRE |
US5916178A (en) * | 1995-03-30 | 1999-06-29 | Medtronic, Inc. | Steerable high support guidewire with thin wall nitinol tube |
US5662622A (en) * | 1995-04-04 | 1997-09-02 | Cordis Corporation | Intravascular catheter |
US5836892A (en) * | 1995-10-30 | 1998-11-17 | Cordis Corporation | Guidewire with radiopaque markers |
US6251086B1 (en) | 1999-07-27 | 2001-06-26 | Scimed Life Systems, Inc. | Guide wire with hydrophilically coated tip |
US5924998A (en) * | 1997-03-06 | 1999-07-20 | Scimed Life System, Inc. | Guide wire with hydrophilically coated tip |
US7494474B2 (en) * | 1997-06-04 | 2009-02-24 | Advanced Cardiovascular Systems, Inc. | Polymer coated guidewire |
US5919126A (en) * | 1997-07-07 | 1999-07-06 | Implant Sciences Corporation | Coronary stent with a radioactive, radiopaque coating |
US6010445A (en) * | 1997-09-11 | 2000-01-04 | Implant Sciences Corporation | Radioactive medical device and process |
US6132388A (en) | 1997-10-16 | 2000-10-17 | Scimed Life Systems, Inc. | Guide wire tip |
US6175760B1 (en) | 1998-02-17 | 2001-01-16 | University Of Iowa Research Foundation | Lesion localizer for nuclear medicine |
US20080140101A1 (en) * | 2006-12-07 | 2008-06-12 | Revascular Therapeutic, Inc. | Apparatus for crossing occlusions or stenoses |
US20060074442A1 (en) * | 2000-04-06 | 2006-04-06 | Revascular Therapeutics, Inc. | Guidewire for crossing occlusions or stenoses |
US6746422B1 (en) | 2000-08-23 | 2004-06-08 | Norborn Medical, Inc. | Steerable support system with external ribs/slots that taper |
US9254143B2 (en) * | 1998-02-25 | 2016-02-09 | Revascular Therapeutics, Inc. | Guidewire for crossing occlusions or stenoses having a shapeable distal end |
US6824550B1 (en) | 2000-04-06 | 2004-11-30 | Norbon Medical, Inc. | Guidewire for crossing occlusions or stenosis |
US20070225615A1 (en) * | 2006-03-22 | 2007-09-27 | Revascular Therapeutics Inc. | Guidewire controller system |
US6059767A (en) | 1998-02-25 | 2000-05-09 | Norborn Medical, Inc. | Steerable unitary infusion catheter/guide wire incorporating detachable infusion port assembly |
EP0947221A3 (en) * | 1998-03-31 | 2000-04-26 | Terumo Kabushiki Kaisha | Laser irradiation device |
US6139511A (en) * | 1998-06-29 | 2000-10-31 | Advanced Cardiovascular Systems, Inc. | Guidewire with variable coil configuration |
AU1191801A (en) * | 1999-10-04 | 2001-05-10 | Novoste Corporation | Interventional injury sizing tool for vascular and non-vascular applications |
WO2001030254A1 (en) | 1999-10-26 | 2001-05-03 | Cedara Software Corp. | Catheter with radiopaque markers for 3d position tracking |
EP1229957B1 (en) * | 1999-11-16 | 2008-08-06 | Abbott Cardiovascular Systems, Inc. | Polymer coated guidewire |
US6520934B1 (en) | 1999-12-29 | 2003-02-18 | Advanced Cardiovascular Systems, Inc. | Catheter assemblies with flexible radiopaque marker |
US7381198B2 (en) | 2000-08-23 | 2008-06-03 | Revascular Therapeutics, Inc. | Steerable distal support system |
EP3006057A1 (en) | 2000-08-24 | 2016-04-13 | Cordis Corporation | Fluid delivery systems for delivering fluids to multi-lumen catheters |
US6620114B2 (en) * | 2000-10-05 | 2003-09-16 | Scimed Life Systems, Inc. | Guidewire having a marker segment for length assessment |
JP4680372B2 (en) * | 2000-11-15 | 2011-05-11 | 川澄化学工業株式会社 | Guide wire |
US6497646B1 (en) * | 2001-03-14 | 2002-12-24 | Cordis Corporation | Intravascular radiotherapy source ribbon having variable radiopacity |
US6636758B2 (en) | 2001-05-01 | 2003-10-21 | Concentric Medical, Inc. | Marker wire and process for using it |
US6575920B2 (en) | 2001-05-30 | 2003-06-10 | Scimed Life Systems, Inc. | Distal tip portion for a guide wire |
US6702782B2 (en) | 2001-06-26 | 2004-03-09 | Concentric Medical, Inc. | Large lumen balloon catheter |
US6638245B2 (en) * | 2001-06-26 | 2003-10-28 | Concentric Medical, Inc. | Balloon catheter |
US6612998B2 (en) * | 2001-11-28 | 2003-09-02 | Advanced Cardiovascular Systems, Inc. | Guide wire with marker sleeve |
US20050228479A1 (en) * | 2001-11-29 | 2005-10-13 | Cook Incorporated | Medical device delivery system |
US6832715B2 (en) | 2001-12-03 | 2004-12-21 | Scimed Life Systems, Inc. | Guidewire distal tip soldering method |
JP4028245B2 (en) * | 2002-01-28 | 2007-12-26 | テルモ株式会社 | Guide wire |
US7022086B2 (en) | 2002-05-21 | 2006-04-04 | Scimed Life Systems, Inc. | Guidewire with encapsulated marker |
US7153277B2 (en) * | 2002-12-03 | 2006-12-26 | Scimed Life Systems, Inc. | Composite medical device with markers |
AU2003299583A1 (en) * | 2002-12-04 | 2004-06-23 | Lake Region Manufacturing, Inc. | Marked guidewires |
US20040133129A1 (en) * | 2003-01-03 | 2004-07-08 | Mindguard Ltd. | Measurements in a body lumen using guidewire with spaced markers |
US7582740B2 (en) * | 2003-04-17 | 2009-09-01 | The Trustees Of Columbia University In The City Of New York | Methods and kits for detecting SARS-associated coronavirus |
US8337519B2 (en) | 2003-07-10 | 2012-12-25 | Boston Scientific Scimed, Inc. | Embolic protection filtering device |
JP4677205B2 (en) * | 2003-07-17 | 2011-04-27 | テルモ株式会社 | Guide wire |
US20050054952A1 (en) * | 2003-09-05 | 2005-03-10 | Scimed Life Systems, Inc. | Elongated medical device for intracorporal use |
US7540845B2 (en) * | 2003-09-05 | 2009-06-02 | Boston Scientific Scimed, Inc | Medical device coil |
US7833175B2 (en) * | 2003-09-05 | 2010-11-16 | Boston Scientific Scimed, Inc. | Medical device coil |
US20050131316A1 (en) * | 2003-12-15 | 2005-06-16 | Cook Incorporated | Guidewire with flexible tip |
US7641647B2 (en) * | 2003-12-29 | 2010-01-05 | Boston Scientific Scimed, Inc. | Medical device with modified marker band |
ATE546187T1 (en) | 2004-01-09 | 2012-03-15 | Corazon Technologies Inc | MULTILUMINATED CATHETER |
JP3626488B1 (en) * | 2004-03-15 | 2005-03-09 | 朝日インテック株式会社 | Medical guidewire |
US7844344B2 (en) | 2004-03-30 | 2010-11-30 | Medtronic, Inc. | MRI-safe implantable lead |
DE102004023642A1 (en) * | 2004-05-10 | 2005-12-08 | Restate Patent Ag | Catheter guidewire, especially for percutaneous transluminal coronary angioplasty |
JP3694312B1 (en) * | 2005-01-26 | 2005-09-14 | 朝日インテック株式会社 | Medical guidewire |
US8784336B2 (en) | 2005-08-24 | 2014-07-22 | C. R. Bard, Inc. | Stylet apparatuses and methods of manufacture |
DE102005050344A1 (en) * | 2005-10-20 | 2007-05-03 | Siemens Ag | Cryocatheter for medical investigation and treatment equipment for e.g. diagnosis and treatment of heart infarcts, has image capture device that maps region of vessel around balloon arranged near catheter tip |
US20080114435A1 (en) * | 2006-03-07 | 2008-05-15 | Med Institute, Inc. | Flexible delivery system |
US7674253B2 (en) * | 2006-08-18 | 2010-03-09 | Kensey Nash Corporation | Catheter for conducting a procedure within a lumen, duct or organ of a living being |
US20080108974A1 (en) * | 2006-10-20 | 2008-05-08 | Vital Signs, Inc. | Reinforced catheter with radiopaque distal tip and process of manufacture |
US7881806B2 (en) * | 2006-10-31 | 2011-02-01 | Medtronic, Inc. | Medical lead delivery device |
US9044593B2 (en) | 2007-02-14 | 2015-06-02 | Medtronic, Inc. | Discontinuous conductive filler polymer-matrix composites for electromagnetic shielding |
US8308658B2 (en) | 2007-04-13 | 2012-11-13 | Neometrics, Inc. | Medical guidewire |
US8483842B2 (en) | 2007-04-25 | 2013-07-09 | Medtronic, Inc. | Lead or lead extension having a conductive body and conductive body contact |
JP5513394B2 (en) * | 2007-10-11 | 2014-06-04 | ギヴン イメージング(ロサンジェルス)エルエルシー | System for measuring and displaying the location of radiologically contrasted material inside a luminal organ |
US8500697B2 (en) * | 2007-10-19 | 2013-08-06 | Pressure Products Medical Supplies, Inc. | Transseptal guidewire |
WO2009055941A1 (en) * | 2007-10-29 | 2009-05-07 | Schwager Medica | Catheter |
US7806837B2 (en) * | 2007-11-07 | 2010-10-05 | William Cook Europe Aps | Guide wire for catheter |
ES2651898T3 (en) | 2007-11-26 | 2018-01-30 | C.R. Bard Inc. | Integrated system for intravascular catheter placement |
US9521961B2 (en) | 2007-11-26 | 2016-12-20 | C. R. Bard, Inc. | Systems and methods for guiding a medical instrument |
US9649048B2 (en) | 2007-11-26 | 2017-05-16 | C. R. Bard, Inc. | Systems and methods for breaching a sterile field for intravascular placement of a catheter |
US10751509B2 (en) | 2007-11-26 | 2020-08-25 | C. R. Bard, Inc. | Iconic representations for guidance of an indwelling medical device |
US8781555B2 (en) | 2007-11-26 | 2014-07-15 | C. R. Bard, Inc. | System for placement of a catheter including a signal-generating stylet |
US8048471B2 (en) * | 2007-12-21 | 2011-11-01 | Innovatech, Llc | Marked precoated medical device and method of manufacturing same |
US8231926B2 (en) | 2007-12-21 | 2012-07-31 | Innovatech, Llc | Marked precoated medical device and method of manufacturing same |
US7811623B2 (en) * | 2007-12-21 | 2010-10-12 | Innovatech, Llc | Marked precoated medical device and method of manufacturing same |
US7714217B2 (en) * | 2007-12-21 | 2010-05-11 | Innovatech, Llc | Marked precoated strings and method of manufacturing same |
US8231927B2 (en) | 2007-12-21 | 2012-07-31 | Innovatech, Llc | Marked precoated medical device and method of manufacturing same |
ATE550065T1 (en) * | 2007-12-28 | 2012-04-15 | Terumo Corp | GUIDE WIRE |
JP5430065B2 (en) * | 2007-12-28 | 2014-02-26 | テルモ株式会社 | Guide wire |
JP5354916B2 (en) * | 2008-01-25 | 2013-11-27 | テルモ株式会社 | Transendoscopic guidewire |
US9037263B2 (en) | 2008-03-12 | 2015-05-19 | Medtronic, Inc. | System and method for implantable medical device lead shielding |
ES2525525T3 (en) * | 2008-08-22 | 2014-12-26 | C.R. Bard, Inc. | Catheter assembly that includes ECG and magnetic sensor assemblies |
IT1391568B1 (en) * | 2008-09-05 | 2012-01-11 | E V R Endovascular Res Es S A | CABLE GUIDE TO NAVIGATION THROUGH AN ANATOMY WITH BRANCHED DUCTS |
US8657821B2 (en) * | 2008-11-14 | 2014-02-25 | Revascular Therapeutics Inc. | Method and system for reversibly controlled drilling of luminal occlusions |
US8162891B2 (en) * | 2008-11-26 | 2012-04-24 | Revascular Therapeutics, Inc. | Delivery and exchange catheter for storing guidewire |
EP2410926A4 (en) * | 2009-03-25 | 2012-12-05 | Svelte Medical Systems Inc | Balloon delivery apparatus and method for using and manufacturing the same |
EP2429631B1 (en) | 2009-04-30 | 2014-09-10 | Medtronic, Inc. | Termination of a shield within an implantable medical lead |
US9532724B2 (en) | 2009-06-12 | 2017-01-03 | Bard Access Systems, Inc. | Apparatus and method for catheter navigation using endovascular energy mapping |
CN102821679B (en) | 2010-02-02 | 2016-04-27 | C·R·巴德股份有限公司 | For the apparatus and method that catheter navigation and end are located |
EP2912999B1 (en) | 2010-05-28 | 2022-06-29 | C. R. Bard, Inc. | Apparatus for use with needle insertion guidance system |
JP5392784B2 (en) * | 2010-06-17 | 2014-01-22 | 朝日インテック株式会社 | Medical guidewire |
JP5736735B2 (en) * | 2010-11-09 | 2015-06-17 | 住友ベークライト株式会社 | catheter |
US8900652B1 (en) | 2011-03-14 | 2014-12-02 | Innovatech, Llc | Marked fluoropolymer surfaces and method of manufacturing same |
JP5743267B2 (en) * | 2011-06-30 | 2015-07-01 | 朝日インテック株式会社 | Guide wire |
US10029076B2 (en) | 2012-02-28 | 2018-07-24 | Covidien Lp | Intravascular guidewire |
EP2838609B1 (en) | 2012-04-19 | 2019-03-06 | Medtronic, Inc. | Paired medical lead bodies with braided conductive shields having different physical parameter values |
JP6368307B2 (en) | 2012-08-23 | 2018-08-01 | ボルケーノ コーポレイション | Apparatus, system, and method using radiopaque members for anatomical damage length estimation |
US9504476B2 (en) * | 2012-10-01 | 2016-11-29 | Microvention, Inc. | Catheter markers |
JP2014213126A (en) * | 2013-04-30 | 2014-11-17 | 朝日インテック株式会社 | Guide wire |
US9993638B2 (en) | 2013-12-14 | 2018-06-12 | Medtronic, Inc. | Devices, systems and methods to reduce coupling of a shield and a conductor within an implantable medical lead |
CN105979868B (en) | 2014-02-06 | 2020-03-10 | C·R·巴德股份有限公司 | Systems and methods for guidance and placement of intravascular devices |
JP6294211B2 (en) * | 2014-02-24 | 2018-03-14 | 朝日インテック株式会社 | Guide wire |
DE202014100863U1 (en) * | 2014-02-26 | 2014-03-14 | Cormedics Medizintechnik GmbH | Guidewire for medical devices |
JPWO2015141290A1 (en) | 2014-03-19 | 2017-04-06 | テルモ株式会社 | Guide wire |
EP3145414B1 (en) | 2014-05-20 | 2021-10-13 | Koninklijke Philips N.V. | Intravascular devices having drive cables with radiopaque markers |
JP6476614B2 (en) * | 2014-07-03 | 2019-03-06 | 住友ベークライト株式会社 | Medical equipment |
EP3171931B1 (en) | 2014-07-23 | 2021-11-10 | Medtronic, Inc. | Methods of shielding implantable medical leads and implantable medical lead extensions |
WO2016014816A1 (en) | 2014-07-24 | 2016-01-28 | Medtronic, Inc. | Methods of shielding implantable medical leads and implantable medical lead extensions |
US11090465B2 (en) | 2014-08-21 | 2021-08-17 | Boston Scientific Scimed, Inc. | Medical device with support member |
US10973584B2 (en) | 2015-01-19 | 2021-04-13 | Bard Access Systems, Inc. | Device and method for vascular access |
JP5967255B2 (en) * | 2015-04-15 | 2016-08-10 | 住友ベークライト株式会社 | Catheter and method for manufacturing catheter |
JP5948535B1 (en) * | 2015-05-29 | 2016-07-06 | 株式会社エフエムディ | Medical guidewire |
US10349890B2 (en) | 2015-06-26 | 2019-07-16 | C. R. Bard, Inc. | Connector interface for ECG-based catheter positioning system |
US20170072165A1 (en) | 2015-09-11 | 2017-03-16 | Cathera, Inc. | Catheter shaft and associated devices, systems, and methods |
US11000207B2 (en) | 2016-01-29 | 2021-05-11 | C. R. Bard, Inc. | Multiple coil system for tracking a medical device |
US11000880B2 (en) * | 2016-04-25 | 2021-05-11 | Les Solutions Medicales Soundbite Inc. | Mechanical waveguide provided with a marker thereon |
US11207502B2 (en) | 2016-07-18 | 2021-12-28 | Scientia Vascular, Llc | Guidewire devices having shapeable tips and bypass cuts |
US11052228B2 (en) | 2016-07-18 | 2021-07-06 | Scientia Vascular, Llc | Guidewire devices having shapeable tips and bypass cuts |
WO2019064607A1 (en) * | 2017-09-30 | 2019-04-04 | 朝日インテック株式会社 | Guide wire |
US10953195B2 (en) | 2018-06-01 | 2021-03-23 | Covidien Lp | Flexible tip catheter |
CN108926763A (en) * | 2018-07-28 | 2018-12-04 | 上海上医康鸽医用器材有限责任公司 | Microtubular, push component, Embolism for fallopian tube, dredging, contrast apparatus and application method |
WO2020081373A1 (en) | 2018-10-16 | 2020-04-23 | Bard Access Systems, Inc. | Safety-equipped connection systems and methods thereof for establishing electrical connections |
US11452533B2 (en) | 2019-01-10 | 2022-09-27 | Abbott Cardiovascular Systems Inc. | Guide wire tip having roughened surface |
US20210228845A1 (en) * | 2020-01-23 | 2021-07-29 | Scientia Vascular, Llc | Guidewire having enlarged, micro-fabricated distal section |
JPWO2022003931A1 (en) * | 2020-07-03 | 2022-01-06 | ||
WO2022072795A1 (en) | 2020-10-01 | 2022-04-07 | Teleflex Medical Incorporated | Stylet with improved threadability |
Family Cites Families (46)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3757768A (en) * | 1972-04-07 | 1973-09-11 | Medical Evaluation Devices And | Manipulable spring guide-catheter and tube for intravenous feeding |
US4279252A (en) * | 1979-08-24 | 1981-07-21 | Martin Michael T | X-ray scaling catheter |
US4545390A (en) * | 1982-09-22 | 1985-10-08 | C. R. Bard, Inc. | Steerable guide wire for balloon dilatation procedure |
US4456017A (en) * | 1982-11-22 | 1984-06-26 | Cordis Corporation | Coil spring guide with deflectable tip |
USRE33911E (en) * | 1983-07-13 | 1992-05-05 | Advanced Cardiovascular Systems, Inc. | Catheter guide wire with short spring tip and method of using the same |
US4538622A (en) * | 1983-11-10 | 1985-09-03 | Advanced Cardiovascular Systems, Inc. | Guide wire for catheters |
US4619274A (en) * | 1985-04-18 | 1986-10-28 | Advanced Cardiovascular Systems, Inc. | Torsional guide wire with attenuated diameter |
US4721117A (en) * | 1986-04-25 | 1988-01-26 | Advanced Cardiovascular Systems, Inc. | Torsionally stabilized guide wire with outer jacket |
EP0247371A1 (en) * | 1986-05-23 | 1987-12-02 | Sarcem Sa | Catheter guide |
US4763647A (en) * | 1987-01-06 | 1988-08-16 | C. R. Bard, Inc. | Dual coil steerable guidewire |
US4821722A (en) * | 1987-01-06 | 1989-04-18 | Advanced Cardiovascular Systems, Inc. | Self-venting balloon dilatation catheter and method |
US4757827A (en) * | 1987-02-17 | 1988-07-19 | Versaflex Delivery Systems Inc. | Steerable guidewire with deflectable tip |
US4815478A (en) * | 1987-02-17 | 1989-03-28 | Medtronic Versaflex, Inc. | Steerable guidewire with deflectable tip |
US4796637A (en) * | 1987-06-17 | 1989-01-10 | Victory Engineering Company | Radiopaque marker for stereotaxic catheter |
US4867174A (en) * | 1987-11-18 | 1989-09-19 | Baxter Travenol Laboratories, Inc. | Guidewire for medical use |
US4846186A (en) * | 1988-01-12 | 1989-07-11 | Cordis Corporation | Flexible guidewire |
US4895168A (en) * | 1988-01-21 | 1990-01-23 | Schneider (Usa) Inc., A Pfizer Company | Guidewire with movable core and external tubular safety cover |
US4873983A (en) * | 1988-01-27 | 1989-10-17 | Advanced Biomedical Devices, Inc. | Steerable guidewire for vascular system |
US4884579A (en) * | 1988-04-18 | 1989-12-05 | Target Therapeutics | Catheter guide wire |
US5065769A (en) * | 1988-11-23 | 1991-11-19 | Boston Scientific Corporation | Small diameter guidewires of multi-filar, cross-wound coils |
US4957110A (en) * | 1989-03-17 | 1990-09-18 | C. R. Bard, Inc. | Steerable guidewire having electrodes for measuring vessel cross-section and blood flow |
US5063935A (en) * | 1989-04-27 | 1991-11-12 | C. R. Bard, Inc. | Catheter guidewire with varying radiopacity |
US4922924A (en) * | 1989-04-27 | 1990-05-08 | C. R. Bard, Inc. | Catheter guidewire with varying radiopacity |
CA2019063E (en) * | 1989-06-29 | 2000-01-04 | Brian L. Bates | Hydrophilically coated flexible wire guide |
US5144959A (en) * | 1989-08-15 | 1992-09-08 | C. R. Bard, Inc. | Catheter guidewire with varying radiopacity |
US5084022A (en) * | 1989-10-04 | 1992-01-28 | Lake Region Manufacturing Company, Inc. | Graduated guidewire |
US5209730A (en) * | 1989-12-19 | 1993-05-11 | Scimed Life Systems, Inc. | Method for placement of a balloon dilatation catheter across a stenosis and apparatus therefor |
US5095915A (en) * | 1990-03-19 | 1992-03-17 | Target Therapeutics | Guidewire with flexible distal tip |
US5147317A (en) * | 1990-06-04 | 1992-09-15 | C.R. Bard, Inc. | Low friction varied radiopacity guidewire |
US5069217A (en) * | 1990-07-09 | 1991-12-03 | Lake Region Manufacturing Co., Inc. | Steerable guide wire |
US5040543A (en) * | 1990-07-25 | 1991-08-20 | C. R. Bard, Inc. | Movable core guidewire |
US5178158A (en) * | 1990-10-29 | 1993-01-12 | Boston Scientific Corporation | Convertible guidewire-catheter with soft tip |
US5211636A (en) * | 1990-10-31 | 1993-05-18 | Lake Region Manufacturing Co., Inc. | Steerable infusion guide wire |
US5174302A (en) * | 1990-12-04 | 1992-12-29 | Cordis Corporation | Variable radiopacity guidewire with spaced highly radiopaque regions |
FR2671009B1 (en) * | 1990-12-28 | 1993-03-12 | Nivarox Sa | GUIDE SUPPORT FOR CATHETER. |
US5184627A (en) * | 1991-01-18 | 1993-02-09 | Boston Scientific Corporation | Infusion guidewire including proximal stiffening sheath |
ATE164088T1 (en) * | 1991-05-07 | 1998-04-15 | Target Therapeutics Inc | CATHETER GUIDE WIRE |
US5228453A (en) * | 1991-05-07 | 1993-07-20 | Target Therapeutics, Inc. | Catheter guide wire |
US5241970A (en) * | 1991-05-17 | 1993-09-07 | Wilson-Cook Medical, Inc. | Papillotome/sphincterotome procedures and a wire guide specially |
CA2068584C (en) * | 1991-06-18 | 1997-04-22 | Paul H. Burmeister | Intravascular guide wire and method for manufacture thereof |
US5333620A (en) † | 1991-10-30 | 1994-08-02 | C. R. Bard, Inc. | High performance plastic coated medical guidewire |
US5253653A (en) * | 1991-10-31 | 1993-10-19 | Boston Scientific Corp. | Fluoroscopically viewable guidewire for catheters |
US5465732A (en) * | 1992-03-31 | 1995-11-14 | Boston Scientific Corporation | Fluoroscopically viewable multifilar calibrated guidewire and method of measuring occlusions with calibrated guidewires |
US5259393A (en) * | 1992-05-13 | 1993-11-09 | Cordis Corporation | Guidewire having controlled radiopacity tip |
US5267574A (en) * | 1992-09-10 | 1993-12-07 | Cordis Corporation | Guidewire with spring and a heat shrinkable connection |
US5409004A (en) * | 1993-06-11 | 1995-04-25 | Cook Incorporated | Localization device with radiopaque markings |
-
1995
- 1995-02-03 US US08/383,322 patent/US5606981A/en not_active Expired - Lifetime
- 1995-03-09 WO PCT/US1995/003076 patent/WO1995024237A2/en active IP Right Grant
- 1995-03-09 JP JP7523682A patent/JPH09510125A/en not_active Ceased
- 1995-03-09 DE DE69517518T patent/DE69517518T3/en not_active Expired - Fee Related
- 1995-03-09 EP EP95914010A patent/EP0749334B2/en not_active Expired - Lifetime
- 1995-03-09 CA CA002184484A patent/CA2184484A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
JPH09510125A (en) | 1997-10-14 |
WO1995024237A3 (en) | 1995-10-26 |
DE69517518T3 (en) | 2005-02-03 |
US5606981A (en) | 1997-03-04 |
EP0749334B1 (en) | 2000-06-14 |
EP0749334A1 (en) | 1996-12-27 |
DE69517518T2 (en) | 2001-03-08 |
WO1995024237A2 (en) | 1995-09-14 |
EP0749334B2 (en) | 2004-08-25 |
DE69517518D1 (en) | 2000-07-20 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CA2184484A1 (en) | Catheter guidewire with radiopaque markers | |
EP0812599B1 (en) | Catheter guide wire | |
US5228453A (en) | Catheter guide wire | |
EP0759793B1 (en) | Catheter guide wire with multiple radiopacity | |
US4922924A (en) | Catheter guidewire with varying radiopacity | |
US5377690A (en) | Guidewire with round forming wire | |
EP1803482B1 (en) | High performance coil wire | |
CA2228346C (en) | Guidewire having a distal tip that can change its shape within a vessel | |
EP0914175B1 (en) | Guide wire with hydrophilically coated tip | |
EP0823261B1 (en) | Guidewire having a distal tip that can change its shape within a vessel | |
EP1339355B1 (en) | Balloon catheter with radiopaque distal tip | |
US6036682A (en) | Catheter having a plurality of integral radiopaque bands | |
US6612998B2 (en) | Guide wire with marker sleeve | |
EP0832664B1 (en) | Guidewire having radiopaque distal tip | |
US20050075582A1 (en) | Guide wire with hydrophilically coated tip | |
WO1992013483A1 (en) | Multifilar coil guide wire | |
US20080183182A1 (en) | Guide wire |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
FZDE | Discontinued |