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WO1992014508A1 - Fil de guidage stable a la torsion - Google Patents

Fil de guidage stable a la torsion Download PDF

Info

Publication number
WO1992014508A1
WO1992014508A1 PCT/US1992/001217 US9201217W WO9214508A1 WO 1992014508 A1 WO1992014508 A1 WO 1992014508A1 US 9201217 W US9201217 W US 9201217W WO 9214508 A1 WO9214508 A1 WO 9214508A1
Authority
WO
WIPO (PCT)
Prior art keywords
guidewire
spring member
guidewire according
tubular member
catheter
Prior art date
Application number
PCT/US1992/001217
Other languages
English (en)
Inventor
Vern L. Leibmann
Scott J. Solano
Original Assignee
Mallinckrodt Medical, Inc.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Mallinckrodt Medical, Inc. filed Critical Mallinckrodt Medical, Inc.
Publication of WO1992014508A1 publication Critical patent/WO1992014508A1/fr

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
    • A61M2025/09066—Basic structures of guide wires having a coil without a core possibly combined with a sheath

Definitions

  • the present invention relates to guidewires used for the insertion of catheters into the vascular system or other organs or systems of a living being.
  • the present invention relates to angioplasty guidewires used for guiding balloon catheters into the vascular system, such balloon catheters being used for treatment of arterial vascular blockage.
  • the present invention relates to a guidewire which may be used to deliver drugs or other agents to particular internal locations within a living being.
  • Catheters are used in numerous procedures for the treatment of disorders or various organs or systems of a living being.
  • catheters are often used to administer drugs directly to an organ or system which is hard to access by other means; such as, areas of the general vasculature system, for example, distal arteries of the lower leg, renal arteries, etc.
  • catheters are often used in neuroradiology procedures in order to open blood vessels, for example by the injection of drugs; or to close blood vessels, for example by use of an embolization agent or device.
  • catheters are often used in the treatment of general disorders to organs and systems of the living being, such as the fallopian tubes, etc.
  • PTCA PTCA
  • a guidewire of relatively fine diameter is first inserted directly into the vascular system of the patient and then is steered and manipulated through the vascular system until it crosses the area of lesion or blockage which it is desired to treat.
  • the balloon catheter is then inserted over the guidewire, and is pushed through the vascular system following the path of the guidewire, until the balloon portion of the catheter is properly located within the area of lesion or blockage.
  • vascular system and body passages through which the guidewire must pass are generally sinuous and irregular, and also connect with other passages at various and sometimes sharp angles, manipulation of the guidewire is a difficult and delicate process. Therefore, a guidewire must be torsionally stable to the extent that when the proximal end of the guidewire is rotated, torque is transmitted to the distal tip of the guidewire, without kinking or breaking. Further, a guidewire must have enough flexibility at the distal tip to assure safe passage through the fragile vascular system or passages and to assure relatively easy manipulation through the tortious curves and angles of the vascular system or passages necessary to reach the desired location.
  • SUBSTITUTE SHEET torsional stability to allow the transmission of torque from the proximal end of the guidewire to the distal end of the guidewire.
  • torsional stability is provided by use of a single, continuous corewire, which is formed of a material having a sufficiently high strength modulus to assure that torque may be transmitted from the proximal end to the distal tip.
  • a common material used is stainless steel, or the like.
  • Flexibility of the distal tip in this type of guidewire is provided by tapering down the distal end of the corewire (generally over the distal 30 cm of the corewire) . The tapered portion of the corewire is then covered with a radiopaque metal coil in order to increase flexibility and to provide means to fluoroscopically visualize the guidewire when it is inserted into the vascular system.
  • these prior art guidewires do not have any way of varying the flexibility of an individual guidewire at the distal end, and therefore do not possess optimum maneuverability. Rather, in order to have different flexibilities available, several separate guidewires are required, each having a differently configured distal end. Therefore, if it is found during insertion of a guidewire that more or less flexibility is required to push the guidewire past a particular curve of turn, then the first guidewire must be removed, and a second guidewire possessing the newly desired flexibility must be inserted.
  • U.S. patent 4,873,983 to Winters teaches a guidewire which includes a helically wound tapered spring attached to a length of hollow tubing, through which a corewire may be variable extended or retracted to control the curvature and flexibility of the spring. Therefore, this prior art guidewire provides means of continuously optimizing the flexibility of the guidewire as it is pushed through the vascular system.
  • this guidewire is disadvantageous in that there is no means provided by which adequate torque may be transmitted from the proximal end to the distal end. In particular, upon rotation of the proximal end of the guidewire, the tapered spring at the distal end tends to collapse or expand, rather than rotate.
  • the present invention relates to a device comprised of an outer core through which torque may be transmitted from the proximal end to the distal end, without the need for a fixed corewire.
  • a continuous lumen within the outer core is created which runs the length of the outer core. This lumen may be utilized to allow the
  • SUBSTITUTE SHEET passage of separate and discrete devices through the device such as a oveable tapered corewire for varying the shape and flexibility of the device tip, optical fibers for various well known applications, electrical leads for attachment to various sensors, etc.
  • the central lumen may be used to administer small quantities of drugs or the like directly to a treatment site.
  • the device according to the present invention comprises a long thin metal cylinder with a cylindrical segment of wire filaments attached at the distal end.
  • the wire filaments are formed or treated in such a way that relative movement between adjacent filaments of the wire is prevented or substantially reduced when a torsional moment is applied to the device.
  • Fig. 1 is a cross sectional view of a device according to one embodiment of the present invention.
  • Fig.2 is a cross sectional view of a device according to a second embodiment of the present invention.
  • Figs. 1 and 2 are cross sectional views of a device according to the present invention.
  • the same reference numerals will be used in both drawing figures to designate similar elements of the device according to the present invention.
  • a guidewire generally designated by reference numeral 10, comprises a long tubular member 20, at the proximal end of the guidewire, and a spring member 30, made up of a segment of coiled wire filaments, at the distal end of the guidewire.
  • a single coil of wire filaments is shown, while in Fig. 2, two coils of wire filaments are shown.
  • the tubular member 20 is a long, thin cylinder of metal, such as stainless steel, which has a sufficient length for proper insertion into the patient.
  • a stainless steel tube having an outside diameter of about .010 to .028 inch and an inside diameter of about .004 to .025 inch may be used as tubular member 20.
  • the tubular member 20 is formed of a stainless steel tube with an outside diameter of about .018 inch and an inside diameter of about .010 inch.
  • the outer surface of the tubular member 20, may be coated with a thin layer of lubricious material, such as Teflon®, polyethylene, or silicon, to make the guidewire 10, more easily insertable and moveable through the vascular system of the patient.
  • the spring member 30, extends for up to about fifty percent of the total length of the guidewire 10, with a preferred length of about 30 cm, and is attached to the distal end of the tubular member 20, so as to provide a smooth, continuous transition from one to the other. As can be seen in the drawing figure, the spring member 30, tapers slightly over its length, getting smaller in diameter toward a distal tip 50.
  • SUBSTITUTE S * up the spring member 30, are optimally formed from a metal, such as 316L stainless steel, or from a strong polymeric fiber, such as Kevlar®. Further, the wire filaments should each have a diameter of from .001 to .005 inch, with a preferred diameter of about .003 inch, and may have a round or flat cross-section, the flat configuration having the advantage of greater strength while saving space.
  • a spring member as described above is not capable of transmitting torque because of the tendency of the wire filaments to move with respect to each other when a torsional moment is applied.
  • the adjacent wire filaments tend to contract and expand relative to one another upon application of torque, rather than transmitting the torque along the length of the spring member. Therefore, according to the present invention, the spring member 30, is treated in such a way as to prevent the relative movement of the wire filaments.
  • the wire filaments of the spring member 30, are braided in order to provide torsional stability.
  • the tendency of adjacent wire filaments to contract and expand may be overcome, thus enabling the spring member 30, to pass torque along its entire length.
  • the braids of the wire filaments can be of a standard one- over-one-under, or two-over-two-under configuration, with any suitable number of plaits per inch.
  • torsional stability and flexibility are provided by using multiple, concentric coils of flat metal bands for the spring member 30.
  • at least two concentric coils of flat metal are provided.
  • SUBSTITUTE SHEET bands are used. While only two concentric coils are shown in Fig. 2, it is understood that three or more concentric coils may be used.
  • the tendency toward expansion and contraction upon application of a torsional moment is overcome.
  • the tendency of a particular coil to expand and unwind is counteracted by the tendency of an adjacent coil to contract or wind tighter. Therefore, the overall effect is the transmission of torque along the entire length of the spring member 30, with no overall change in the dimension of the spring member 30.
  • the spring member 30, may be encapsulated with an encapsulating material 40, such as a soft, flexible polymeric substance.
  • an encapsulating material 40 such as a soft, flexible polymeric substance.
  • the encapsulating material 40 also acts to prevent bodily fluids from seeping through the spring member 30, and into the interior of the guidewire 10. Therefore, the use of the encapsulating material 40, is desirable when the guidewire 10, is to be used for guiding a catheter to a treatment site, the catheter then being used to carry out the actual treatment.
  • the guidewire 10, according to the present invention may be used itself to carry out the treatment. In such a case, the encapsulating material 40, may be eliminated, or only partial encapsulation may be used.
  • the spring member 30, may also be treated so as to provide radiopacity.
  • a short segment of a radiodense metal such as platinum, gold, or tantalum, may
  • SUBSTITUTE SHEET be used as a portion of the filaments or coils making up the spring member 30. Further, a portion of the filaments or coils making up the spring member 30, may be encapsulated with a polymer which has been filled with a radiopaque material. Such encapsulation also has the advantage of providing greater softness to the spring member 30.
  • the guidewire 10, according to the present invention has a continuous central lumen throughout the length of the tubular member 20, and the spring member 30.
  • This central lumen may be utilized to allow the passage of separate discrete devices through the guidewire 10.
  • a moveable tapered corewire for varying the shape and flexibility of the guidewire tip, optical fibers for various well known applications, electrical leads for attachment to various sensors, etc. may be passed through the central lumen of the guidewire 10.
  • the central lumen of the guidewire according to the present invention may be used to administer small quantities of drugs or the like directly to a treatment site.
  • a tapered corewire may be inserted into the central lumen and may be used to control the flexibility and shape of the spring member 30.
  • the guidewire 10 may be operated so as to function as any one of a "standard” guidewire, with the tapered corewire extending all the way through the spring member 30; or as a "flexible” guidewire, with the tapered corewire terminating about 2 cm from the distal tip 50; or as a “very flexible” guidewire, with the tapered corewire terminating about 3 cm or more from the distal tip 50.
  • Each of the above functions may be easily achieved by simply extending or retracting the tapered corewire until the desired flexibility is obtained.
  • the tapered corewire may be operated so as to function as any one of a "standard” guidewire, with the tapered corewire extending all the way through the spring member 30; or as a “flexible” guidewire, with the tapered corewire terminating about 2 cm from the distal tip 50; or as a “very flexible” guidewire, with the tapered corewire terminating
  • SUBSTITUTE SHEET tapered corewire may be used to straighten the spring member 30, if such has been previously curved by a bias placed within the filaments or coils.
  • the guidewire 10, according to the present invention is used to directly carry out a particular treatment procedure, such as delivery of drugs or other agents to the treatment site.
  • a particular treatment procedure such as delivery of drugs or other agents to the treatment site.
  • small quantities of drugs may be delivered directly to the treatment site through the central lumen.
  • means must be provided in the spring member 30, for the exit of drugs from the central lumen.
  • it may be desirable to leave the spring member 30, entirely without the encapsulation material 40. Therefore, drugs delivered through the central lumen may simply flow out between the wire filaments making up the spring member 30.
  • the spring member 30, is partially encapsulated in order to provide specific means for delivery of the drugs.
  • holes may be provided through the encapsulating material 40, to allow the drugs to flow out of the central lumen. Any arrangement of holes may be used, such as a single or multiple large holes for discrete or bolus delivery of the drugs to a specific treatment site; or series of small holes to provide a misting effect or delivery to a longer treatment area.
  • the device according to the present invention is very advantageous in providing the necessary flexibility to travel the tortious path of the vascular system or body passages of the patient.
  • the device according to the present invention allows the transmission of torque along its entire length, and
  • SUBSTITUTE SHEET especially along the length of the spring member.
  • Such torsional stability gives the device greater maneuverability and pushability for transversing the vascular system or body passages of the patient.

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)

Abstract

L'invention se rapporte à des fils de guidage servant à introduire des cathéters dans le système vasculaire d'un être vivant et, en particulier, à des fils de guidage pour angioplastie servant à guider dans le système vasculaire des cathéters à ballonnets, lesquels sont utilisés notamment pour le traitement des obstructions artérielles du système vasculaire. Ces fils de guidage sont conçus pour qu'on puisse faire varier la flexibilité de leur pointe, en vue d'optimiser leur aptitude à être poussés et à être man÷uvrés, et ils possèdent également suffisamment de rigidité pour permettre la transmission du couple de l'extrémité proximale à l'extrémité distale du fil sans provoquer de repli ou d'expansion de la pointe. L'invention se rapporte en outre à un fil de guidage pouvant être utilisé pour acheminer des médicaments ou d'autres agents en des endroits particuliers à l'intérieur du corps d'un être vivant.
PCT/US1992/001217 1991-02-15 1992-02-13 Fil de guidage stable a la torsion WO1992014508A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US65693691A 1991-02-15 1991-02-15
US656,936 1991-02-15

Publications (1)

Publication Number Publication Date
WO1992014508A1 true WO1992014508A1 (fr) 1992-09-03

Family

ID=24635188

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1992/001217 WO1992014508A1 (fr) 1991-02-15 1992-02-13 Fil de guidage stable a la torsion

Country Status (2)

Country Link
AU (1) AU1428792A (fr)
WO (1) WO1992014508A1 (fr)

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994020165A3 (fr) * 1993-03-12 1994-10-27 Bard Inc C R Fil guide orientable a configuration anatomique pour angioplastie coronarienne transluminale percutanee
US5497785A (en) * 1994-07-27 1996-03-12 Cordis Corporation Catheter advancing guidewire and method for making same
EP0729765A1 (fr) * 1995-03-02 1996-09-04 Schneider (Europe) Ag Fil de guidage
EP0815894A1 (fr) * 1996-06-28 1998-01-07 Target Therapeutics Fil de guidage avec embout pourvu de fibres
EP0812600A3 (fr) * 1996-06-04 1998-03-18 Cordis Corporation Fil de guidage à extrémité distale flexible
WO1998042399A1 (fr) * 1997-03-25 1998-10-01 Radius Medical Technologies, Inc. Fil-guide flexible avec embout plastique opaque aux rayons x
US5827201A (en) * 1996-07-26 1998-10-27 Target Therapeutics, Inc. Micro-braided guidewire
WO1999025413A1 (fr) * 1997-11-18 1999-05-27 Advanced Cardiovascular Systems, Inc. Guide souple dote d'une partie intermediaire conformee
US5916177A (en) * 1995-04-18 1999-06-29 Schneider (Europe) A.G. Pressure measuring guide wire
EP1302214A3 (fr) * 2001-10-16 2003-07-16 Pacesetter, Inc. Système et appareil pour implanter une sonde endocardiaque dans la région du sinus coronaire
US7476243B2 (en) 1999-01-27 2009-01-13 Boston Scientific Scimed, Inc. Bifurcation stent delivery system
CN102371023A (zh) * 2010-08-10 2012-03-14 朝日英达科株式会社 导线
WO2015063781A1 (fr) * 2013-11-04 2015-05-07 Nitiloop Ltd. Agencement de tubes pour microcathéter
EP3075332A1 (fr) * 2006-02-13 2016-10-05 RetroVascular, inc. Recanalisation de vaisseaux occlus par suivi antérograde et rétrograde contrôlé
WO2018028823A1 (fr) * 2016-08-12 2018-02-15 Haeberle Laser- Und Feinwerktechnik Gmbh & Co. Kg Fil-guide à utiliser dans des sondes médicales tubulaires, notamment pour la thérapie nutritionnelle

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0208787A1 (fr) * 1985-01-11 1987-01-21 Toray Industries, Inc. Micro-tube medical de guidage
WO1987007155A1 (fr) * 1986-05-23 1987-12-03 Critikon, Inc. Polyurethanes radio-opaques et catheters composes de ces materiaux
US4817613A (en) * 1987-07-13 1989-04-04 Devices For Vascular Intervention, Inc. Guiding catheter
WO1989006985A1 (fr) * 1988-01-27 1989-08-10 Advanced Biomedical Devices, Inc. Fil de guidage orientable pour systeme vasculaire
US4932419A (en) * 1988-03-21 1990-06-12 Boston Scientific Corporation Multi-filar, cross-wound coil for medical devices
EP0382974A1 (fr) * 1989-01-23 1990-08-22 C.R. Bard, Inc. Fil de guidage tressé et son utilisation
EP0386921A2 (fr) * 1989-03-02 1990-09-12 Microspring Company, Inc. Dispositif pour transmettre un couple de rotation

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0208787A1 (fr) * 1985-01-11 1987-01-21 Toray Industries, Inc. Micro-tube medical de guidage
WO1987007155A1 (fr) * 1986-05-23 1987-12-03 Critikon, Inc. Polyurethanes radio-opaques et catheters composes de ces materiaux
US4817613A (en) * 1987-07-13 1989-04-04 Devices For Vascular Intervention, Inc. Guiding catheter
WO1989006985A1 (fr) * 1988-01-27 1989-08-10 Advanced Biomedical Devices, Inc. Fil de guidage orientable pour systeme vasculaire
US4932419A (en) * 1988-03-21 1990-06-12 Boston Scientific Corporation Multi-filar, cross-wound coil for medical devices
EP0382974A1 (fr) * 1989-01-23 1990-08-22 C.R. Bard, Inc. Fil de guidage tressé et son utilisation
EP0386921A2 (fr) * 1989-03-02 1990-09-12 Microspring Company, Inc. Dispositif pour transmettre un couple de rotation

Cited By (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994020165A3 (fr) * 1993-03-12 1994-10-27 Bard Inc C R Fil guide orientable a configuration anatomique pour angioplastie coronarienne transluminale percutanee
US5497785A (en) * 1994-07-27 1996-03-12 Cordis Corporation Catheter advancing guidewire and method for making same
EP0729765A1 (fr) * 1995-03-02 1996-09-04 Schneider (Europe) Ag Fil de guidage
US5706826A (en) * 1995-03-02 1998-01-13 Schneider (Europe) A.G. Guide wire with helical coil
JP3403887B2 (ja) 1995-03-02 2003-05-06 シュナイダー・（オイローペ）・ゲーエムベーハー ガイドワイヤ
US5916177A (en) * 1995-04-18 1999-06-29 Schneider (Europe) A.G. Pressure measuring guide wire
US6183424B1 (en) 1995-04-18 2001-02-06 Schneider (Europe) A.G. Pressure measuring guide wire
EP0812600A3 (fr) * 1996-06-04 1998-03-18 Cordis Corporation Fil de guidage à extrémité distale flexible
US5762615A (en) * 1996-06-04 1998-06-09 Cordis Corporation Guideware having a distal tip with variable flexibility
EP0815894A1 (fr) * 1996-06-28 1998-01-07 Target Therapeutics Fil de guidage avec embout pourvu de fibres
US5833631A (en) * 1996-06-28 1998-11-10 Target Therapeutics, Inc. Fiber tip guidewire
US5827201A (en) * 1996-07-26 1998-10-27 Target Therapeutics, Inc. Micro-braided guidewire
WO1998042399A1 (fr) * 1997-03-25 1998-10-01 Radius Medical Technologies, Inc. Fil-guide flexible avec embout plastique opaque aux rayons x
US5885227A (en) * 1997-03-25 1999-03-23 Radius Medical Technologies, Inc. Flexible guidewire with radiopaque plastic tip
WO1999025413A1 (fr) * 1997-11-18 1999-05-27 Advanced Cardiovascular Systems, Inc. Guide souple dote d'une partie intermediaire conformee
US6296616B1 (en) 1997-11-18 2001-10-02 Advanced Cardiovascular Systems, Inc. Guidewire with shaped intermediate portion
US6106485A (en) * 1997-11-18 2000-08-22 Advanced Cardivascular Systems, Inc. Guidewire with shaped intermediate portion
US7476243B2 (en) 1999-01-27 2009-01-13 Boston Scientific Scimed, Inc. Bifurcation stent delivery system
US8398698B2 (en) 1999-01-27 2013-03-19 Boston Scientific Scimed, Inc. Bifurcated stent delivery system
EP1302214A3 (fr) * 2001-10-16 2003-07-16 Pacesetter, Inc. Système et appareil pour implanter une sonde endocardiaque dans la région du sinus coronaire
EP3075332A1 (fr) * 2006-02-13 2016-10-05 RetroVascular, inc. Recanalisation de vaisseaux occlus par suivi antérograde et rétrograde contrôlé
CN102371023A (zh) * 2010-08-10 2012-03-14 朝日英达科株式会社 导线
CN105873629A (zh) * 2013-11-04 2016-08-17 奈缇路有限公司 微导管管体配置
WO2015063781A1 (fr) * 2013-11-04 2015-05-07 Nitiloop Ltd. Agencement de tubes pour microcathéter
JP2016538909A (ja) * 2013-11-04 2016-12-15 ニティループ・リミテッドＮｉｔｉｌｏｏｐ Ｌｔｄ． マイクロカテーテル及びチューブ装置
US10835709B2 (en) 2013-11-04 2020-11-17 Nitiloop Ltd. Microcatheter tubing arrangement
WO2018028823A1 (fr) * 2016-08-12 2018-02-15 Haeberle Laser- Und Feinwerktechnik Gmbh & Co. Kg Fil-guide à utiliser dans des sondes médicales tubulaires, notamment pour la thérapie nutritionnelle
RU2717375C1 (ru) * 2016-08-12 2020-03-23 Хеберле Лазер- Унд Файнверктехник Гмбх Унд Ко. Кг Направляющая проволока для использования в трубкообразных медицинских зондах, в частности для диетотерапии

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