WO2010059409A2 - Dispositifs médicaux comportant des segments visibles au moyen de deux modalités - Google Patents

Dispositifs médicaux comportant des segments visibles au moyen de deux modalités Download PDF

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Publication number
WO2010059409A2
WO2010059409A2 PCT/US2009/062775 US2009062775W WO2010059409A2 WO 2010059409 A2 WO2010059409 A2 WO 2010059409A2 US 2009062775 W US2009062775 W US 2009062775W WO 2010059409 A2 WO2010059409 A2 WO 2010059409A2
Authority
WO
WIPO (PCT)
Prior art keywords
polymeric material
medical device
radiopaque
tungsten
echogenic
Prior art date
Application number
PCT/US2009/062775
Other languages
English (en)
Other versions
WO2010059409A3 (fr
Inventor
Michael J. Ebert
Steven L. Waldhauser
Mark D. Schneider
Original Assignee
Medtronic, 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 Medtronic, Inc. filed Critical Medtronic, Inc.
Priority to EP09745255.1A priority Critical patent/EP2373357B1/fr
Publication of WO2010059409A2 publication Critical patent/WO2010059409A2/fr
Publication of WO2010059409A3 publication Critical patent/WO2010059409A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/18—Materials at least partially X-ray or laser opaque
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • A61L29/085—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/31504—Composite [nonstructural laminate]
    • Y10T428/31725—Of polyamide

Definitions

  • the present disclosure relates generally to medical devices and, more particularly, to medical devices that include selected segments that are visible using both fluoroscopy and ultrasonic imaging.
  • a guide catheter typically includes an elongated sheath that is inserted into a blood vessel or another portion of the body. A catheter or lead is introduced through an inner channel defined by the sheath.
  • one or more selected segments may include visibility materials that are visible under fluoroscopy and/or ultrasonic imaging. Using fluoroscopic or ultrasonic imaging techniques, the physician can visualize the guide catheter, and place the catheter or electrode lead in a desired position. Guide catheters, for example, may incorporate radiopaque and/or echogenic materials to promote visibility. BRIEF DESCRIPTION OF THE VIEWS OF THE DRAWING
  • FIG. 1 is a perspective view of one exemplary medical device in the form of a catheter.
  • FIG. 2 is an enlarged cross-sectional view of a portion of one embodiment of a catheter according to the present disclosure.
  • FIG.3 is an enlarged cross-sectional view of a portion of another embodiment of a catheter according to the present disclosure.
  • the present disclosure is directed to medical devices (such as, e.g., catheters, guide catheters, etc.) that include one or more selected segments that are constructed using visibility materials compounded with one or more polymeric materials that make the selected segments visible using both fluoroscopy and ultrasonic imaging.
  • the visibility material may take the form of tungsten and/or tungsten carbide particles dispersed within a polymeric material.
  • the use of visibility material as described herein can potentially promote enhanced visibility of a medical device (such as a guide catheter) using both fluoroscopic and ultrasonic imaging techniques.
  • a medical device such as a guide catheter
  • This feature provides a physician with flexible imaging options.
  • the medical device can be used by physicians who prefer fluoroscopic imaging, for example, as well as those who prefer ultrasound. In each case, the physician may select the same guide catheter without regard to the desired imaging modality.
  • the use of a visibility material that is both echogenic and radiopaque as an additive to enable both fluoroscopic and ultrasonic imaging can potentially allow the overall additive level to be lower, which may tend to preserve the mechanical properties of a composite blend incorporating the visibility material.
  • a reduced amount of visibility material in a composite blend may also enhance the slittability of a guide catheter. In this manner, the visible material can potentially be loaded into polymeric material in amounts that promote visibility while maintaining slittability.
  • polyether block amides can be loaded with tungsten and/or tungsten carbide to provide visibility using both fluoroscopy and ultrasonic imaging
  • these compositions can, in some instances, suffer from degradation during aging. The degradation can adversely impact the flexibility and other mechanical properties of the segments in which the visibility materials are provided.
  • the approaches to providing the visible medical device segments as described herein may address these aging issues while still retaining an suitable level or enhanced level of visibility using both fluoroscopic and ultrasonic imaging.
  • the present disclosure provides a medical device.
  • the medical device includes: an inner layer including a radiopaque and echogenic material, wherein the radiopaque and echogenic material includes tungsten and/or tungsten carbide particles distributed within a base polymeric material (i.e., a first polymeric material) including a polyether block amide; and an outer layer including an additional polymeric material (i.e., a second polymeric material).
  • the additional polymeric material is a thermoplastic elastomer.
  • the additional polymeric material is more resistant to hydrolysis and/or oxidation than the base polymeric material.
  • the medical device is a guide catheter including an elongated sheath including a proximal end and a distal tip, and at least a portion of the distal tip and/or elongated sheath includes the radiopaque and echogenic material. Methods of preparing such medical devices are also provided.
  • the present disclosure provides a method of increasing the shelf life of at least a portion of a medical device.
  • the method includes: providing a radiopaque and echogenic material including tungsten and/or tungsten carbide particles distributed within a base polymeric material (i.e., a first polymeric material); and forming a layer including an additional polymeric material (i.e., a second polymeric material) over the radiopaque and echogenic material, wherein the additional polymeric material is more resistant to hydrolysis and/or oxidation than the base polymeric material.
  • FIG. 1 is a perspective view of one medical device that may be used in connection with the present disclosure which is in the form of a catheter 10.
  • catheter 10 includes a proximal end 12, distal tip 14, and an elongated sheath 20 extending between the proximal and distal ends.
  • Catheter 10 may be sized for insertion into a lumen, such as a blood vessel, within the human body.
  • Catheter 10 preferably defines at least one inner channel (not shown in FIG. 1) through which other elements such as other catheters, electrode leads, etc. may be inserted.
  • a handle 30 may be coupled to proximal end 12 of catheter 10.
  • a slitter (not shown) may be positioned near proximal end 12, e.g., adjacent handle 20 if the catheter 10 is to be slit during removal of the catheter 10.
  • the sheath 20 of the catheter 10 may include any number of segments, with the sheath 10 including three segments 22, 24, and 26 disposed along the length of catheter 10. Sheath 20 may be formed to provide either a straight or pre-bent shape to catheter 10, depending on the desired end application.
  • Sheath 20 may be manufactured using materials that promote maneuverability and that may also permit slitting along the length of catheter 10.
  • each segment 22, 24, and 26 of the sheath 20 may be constructed of one or more polymeric materials, such as polyether block amide, nylon block polymer, silicone, or polyurethane, as well as composites or mono-polymers.
  • polymeric materials such as polyether block amide, nylon block polymer, silicone, or polyurethane, as well as composites or mono-polymers.
  • An example of one potentially suitable group of polymeric materials that can be used are polyether block amides marketed under the trademark PEBAX and commercially available from Arkema, Inc. (Philadelphia, PA).
  • the sheath may also include other components such as, e.g., reinforcing braids, etc. If a reinforcing braid is provided, it may terminate short of the distal segment 22 such that the flexibility of the sheath 16 is higher within at least the distal segment 22 as compared to the portions of the sheath 16 that do include a reinforcing braid. Examples of some sheath constructions including reinforcing braids or strands are described in, e.g., U.S. Patent No. 7,065,394 (Hobot et al).
  • Medical devices of the present disclosure are constructed to exhibit properties that enhance visibility of selected portions of the medical device when using fluoroscopic or ultrasonic imaging techniques.
  • distal segment 22 is found at the distal tip of catheter 10 and incorporates visibility material that makes the segment 22 visible using both fluoroscopy and ultrasonic imaging modalities.
  • the visibility material also may be provided in other segments and/or along the entire length of the catheter.
  • Each sheath segment 22, 24, and 26 may, in some embodiments, be constructed from a similar material with a similar concentration of tungsten and/or tungsten carbide particles. However, the different sheath segments may be manufactured with polymeric materials that have different hardness characteristics. It may be preferred that the distal segment 22 be flexible such that the distal end of the catheter 10 is more flexible than the segments 24 and 26 such that that tip 14 of the catheter 10 is relatively atraumatic. As a particular illustration, sheath segments 22, 24, and 26 may be constructed from PEBAX material with 25, 35, and 55 Shore D hardnesses, respectively.
  • each sheath segment 22, 24, and 26 may be independently constructed from PEBAX material having a desired hardness (e.g., 25, 35, 40, 55, 63, 70, or 72 Shore D hardness).
  • the tungsten and/or tungsten carbide particles can be added to selected sheath segments 22, 24, and 26 in concentrations that do not significantly degrade the overall mechanical properties of sheath 20, e.g., on the order of about 60 to about 90 percent by weight. As previously described, other ranges can be used.
  • the tungsten and/or tungsten carbide particles can be added to selected sheath segments 22, 24, and 26 in concentrations on the order of about 60 to about 85 percent by weight.
  • the tungsten and/or tungsten carbide particles can be added to selected sheath segments 22, 24, and 26 in concentrations on the order of about 60 to about 80 percent by weight. In another embodiment, the tungsten and/or tungsten carbide particles can be added to selected sheath segments 22, 24, and 26 in concentrations on the order of about 65 to about 80 percent by weight. In another embodiment, the tungsten and/or tungsten carbide particles can be added to selected sheath segments 22, 24, and 26 in concentrations on the order of about 65 to about 75 percent by weight.
  • the tungsten and/or tungsten carbide particles may be added to the base polymeric material (also referred to as the first polymeric material) in sheath segment 22 in the amount of about 70 to about 75 percent by weight and, more preferably, about 73 to about 74 percent by weight.
  • the jet milled tungsten carbide material is added to the polymeric material in a weight of about 73.2 percent by weight.
  • a concentration of 73.2 percent by weight tungsten carbide particles to PEBAX material corresponds to a concentration of about 15 percent by volume.
  • Barium sulfate particles may be added to sheath segments 24 and 26 in the amount of about 20 to about 40 percent by weight and, more preferably, about 30 percent by weight.
  • the catheter 10 is a guide catheter that is to be slit along its length during use
  • the addition of tungsten and/or tungsten carbide particles may offer exceptional echogenicity and, when added to the polymeric material, permit ready slitting along the length of catheter 10.
  • the material forming the sheath 20 becomes difficult to process and, in some cases, difficult to maneuver for insertion into and removal from the body of a patient.
  • polyether block amides can be loaded with tungsten and/or tungsten carbide particles to provide visibility using both fluoroscopy and ultrasonic imaging, it has been discovered that, in some instances, these compositions can potentially suffer from degradation due to temperature (e.g., oxidation) and/or humidity (e.g., hydrolysis). The degradation can adversely impact the flexibility and other properties of the segments in which the visibility materials are provided.
  • temperature e.g., oxidation
  • humidity e.g., hydrolysis
  • the base polymeric material is a thermoplastic material.
  • examples of polymers that can be used as the base polymeric material include, but are not limited to, polyolefins (e.g., polyethylene and/or polypropylene), fluoropolymers, polycarbonates, polyurethanes, polyesters, polyester ethers, polyether block amides, and combinations thereof.
  • the additional polymeric material is a thermoplastic material.
  • polymers that can be used as the additional polymeric material include, but are not limited to, polyolefins (e.g., polyethylene and/or polypropylene), fluoropolymers, polycarbonates, polyurethanes, polyesters, polyester ethers, and combinations thereof.
  • the softening temperature (e.g., melt temperature or glass transition temperature) of the additional polymeric material can be lower than the softening temperature of the base polymeric material.
  • the softening temperature (e.g., melt temperature or glass transition temperature) of the additional polymeric material can be the same as or higher than the softening temperature of the base polymeric material.
  • FIG.2 is an enlarged cross-sectional view of a sheath 120 to illustrate one such construction in which an inner visibility layer 140 that includes particles 142 in a base polymeric material (e.g., polyether block amide) is jacketed by an outer layer 150 that is constructed of an additional polymeric material.
  • the outer layer 150 may extend only over limited portions of the length of the sheath, for example, over only those portions of the sheath 120 that include the particulate loaded inner visibility layer 140 for which protection is desired.
  • a high visibility band in the form of a visibility material loaded into a polymeric ring that is located between a distal segment and the proximal segment of the device.
  • the high visibility band may preferably include a highly loaded tungsten and/or tungsten carbide particles in a polymeric carrier.
  • the band i.e., that forms the inner layer
  • an additional polymeric material i.e., that forms the outer layer
  • the additional polymeric material extending over the high visibility band and extending over the distal segment to the distal tip of the device.
  • the polymeric carrier forming the band 240 may preferably be selected for its ability to be highly loaded with tungsten and/or tungsten carbide particles while retaining some level of flexibility.
  • An example of one potentially suitable group of polymeric materials that can be used for the ring 240 are polyether block amides marketed under the trademark PEBAX. It may further be preferred that the polymeric materials of the ring 240 also remain slittable if the medical device is a guide catheter that is to be slit during use.
  • FIG. 3 is an enlarged cross-sectional view of a portion of one sheath having an inner sleeve 270 over which an optional braided layer 260 is positioned.
  • the sheath 220 also includes a band 240 that is highly loaded with tungsten and/or tungsten carbide particles 242.
  • the band 240 may preferably be positioned over the end of the braided layer 260 to, e.g., assist in containing the filaments or wires making up the braided layer in addition to providing visibility.
  • AU of the features, such as the band 240, braided layer 260, and inner sleeve 270 are then jacketed with an outer layer 250 in a manner similar to that described in connection with FIG. 2.
  • Medical devices that include a more hydrolytically stable outer layer over a visibility material-loaded inner layer or ring can be prepared by a wide variety of methods including, for example, coextrusion.
  • an inner layer including tungsten and/or tungsten carbide particles in polyether block amide and an outer layer including a polyurethane can be coextruded.
  • the inner layer can be extruded, and the outer layer can subsequently be extruded on the inner layer.
  • the band that includes tungsten and/or tungsten carbide particles in the base polymer can be constructed by a wide variety of convenient methods.
  • An outer layer can then be formed over the inner components by a wide variety of convenient methods. Methods for constructing or forming the inner and outer layers include, but are not limited to, forming one or both layers on a mandrel; extruding one or both layers; injection molding one or both layers; compression molding one or both layers, dip coating, fusing, or combinations thereof.
  • an outer layer that is more resistant to hydrolysis and/or oxidation can be provided over a visibility material- loaded inner layer (e.g., a tungsten and/or tungsten carbide loaded polyether block amide core) to form at least a portion of a medical device.
  • a medical device that includes an outer layer that is more resistant to hydrolysis and/or oxidation can have increased shelf life in comparison to comparable medical devices without the outer layer.
  • the outer layer includes a thermoplastic elastomer such as, e.g., a polyurethane.
  • Tungsten particles (as opposed to tungsten carbide particles) can be selected as a visibility material. Generally, tungsten particles may have less of a tendency to effect degradation (e.g., less catalytic filler) than tungsten carbide particles.
  • Polyurethane (as opposed to polyether block amide) can be selected as the base polymeric material into which the visibility particles are loaded.
  • the polyurethane may be limited to the portion of the medical device (e.g., catheter) that incorporates the visibility material.
  • Polyurethanes can be more hydrolytically stable than, for example, polyether block amides. Tungsten and/or tungsten carbide particles may be used with this approach.
  • Tungsten carbide and/or tungsten particles can be used as the visibility material in a higher durometer polyether block amide (e.g., such as those available under the trade designation PEBAX MX 1205 polyether block amides from Arkema), with the loading level of the visibility material reduced to offset the higher durometer of the polymeric material such that the resulting composite material retains selected mechanical properties, e.g., still provides an atraumatic tip.
  • a higher durometer polyether block amide e.g., such as those available under the trade designation PEBAX MX 1205 polyether block amides from Arkema
  • One or more additives can be used to enhance stability by reducing hydrolysis and/or oxidation.
  • the additives may include one or more of: antioxidants (e.g., a peroxide decomposer such as IRGAFOS 168; a non-polar anti-oxidant such as IRGANOX 1098; metal deactivators such as IRGANOX MD-1024; etc.); anti- hydrolysis agents (e.g., carbodiimides such as, e.g., CARBAXOL, etc.); etc.
  • the medical device can be sterilized using ethylene oxide or other sterilization methodologies, and the sterile pouch can be placed into a bag that is impervious to moisture and/or oxygen.
  • this bag can be back filled with a dry (inert) gas, such as nitrogen, argon, and the like, and then the bag can be sealed.
  • the medical device pouch can be placed into a bag that is impervious to moisture and/or oxygen, a dessicant can be added to adsorb any moisture present in the bag, and then the bag can be sealed.
  • the medical device can be sterilized and placed in a moisture proof package that includes added dessicant, the package can be purged with a dry (inert) gas, and the package sealed.
  • the bag can be purged with a humidified gas such that the relative humidity is less than or equal to about 30 percent to prevent unnecessary drying of the hydrophilic polymer.

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne la préparation et l'utilisation de dispositifs médicaux comportant une couche externe sur une couche interne chargée d'une matière de visibilité.
PCT/US2009/062775 2008-11-23 2009-10-30 Dispositifs médicaux comportant des segments visibles au moyen de deux modalités WO2010059409A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP09745255.1A EP2373357B1 (fr) 2008-11-23 2009-10-30 Dispositifs médicaux comportant des segments visibles au moyen de deux modalités

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11720008P 2008-11-23 2008-11-23
US61/117,200 2008-11-23

Publications (2)

Publication Number Publication Date
WO2010059409A2 true WO2010059409A2 (fr) 2010-05-27
WO2010059409A3 WO2010059409A3 (fr) 2011-01-13

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EP (1) EP2373357B1 (fr)
WO (1) WO2010059409A2 (fr)

Cited By (2)

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US8591783B2 (en) 2008-11-23 2013-11-26 Medtronic, Inc. Medical devices with encapsulated visibility particles
JP2017514595A (ja) * 2014-04-30 2017-06-08 エンキャプソン・ベー・フェー エコー発生の改善のために不均一なコーティングを有する医療デバイス

Families Citing this family (6)

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US10219887B2 (en) 2013-03-14 2019-03-05 Volcano Corporation Filters with echogenic characteristics
WO2014152365A2 (fr) 2013-03-14 2014-09-25 Volcano Corporation Filtres ayant des caractéristiques échogènes
US10292677B2 (en) 2013-03-14 2019-05-21 Volcano Corporation Endoluminal filter having enhanced echogenic properties
JP2016517333A (ja) 2013-03-15 2016-06-16 ボルケーノ コーポレイション 圧力及び超音波機能を持つ遠位保護システム及び方法
JP2017528263A (ja) 2014-09-24 2017-09-28 コーニンクレッカ フィリップス エヌ ヴェＫｏｎｉｎｋｌｉｊｋｅ Ｐｈｉｌｉｐｓ Ｎ．Ｖ． 向上されたエコー源性特性を有する管腔内フィルタ
EP3366322B1 (fr) 2017-02-22 2021-04-28 Cook Medical Technologies LLC Dispositif médical avec particules de métal radio-opaques dispersées dans un polymère

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8591783B2 (en) 2008-11-23 2013-11-26 Medtronic, Inc. Medical devices with encapsulated visibility particles
JP2017514595A (ja) * 2014-04-30 2017-06-08 エンキャプソン・ベー・フェー エコー発生の改善のために不均一なコーティングを有する医療デバイス

Also Published As

Publication number Publication date
US20100130963A1 (en) 2010-05-27
EP2373357B1 (fr) 2015-12-23
EP2373357A2 (fr) 2011-10-12
WO2010059409A3 (fr) 2011-01-13

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