EP0056394A4 - IMPROVED MEDICAL TUBES OPAQUE TO RADIATION. - Google Patents
IMPROVED MEDICAL TUBES OPAQUE TO RADIATION.Info
- Publication number
- EP0056394A4 EP0056394A4 EP19810902089 EP81902089A EP0056394A4 EP 0056394 A4 EP0056394 A4 EP 0056394A4 EP 19810902089 EP19810902089 EP 19810902089 EP 81902089 A EP81902089 A EP 81902089A EP 0056394 A4 EP0056394 A4 EP 0056394A4
- Authority
- EP
- European Patent Office
- Prior art keywords
- tubing
- stripes
- medical tubing
- radiopaque
- medical
- 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.)
- Withdrawn
Links
- 239000000463 material Substances 0.000 claims abstract description 41
- 239000012815 thermoplastic material Substances 0.000 claims abstract description 8
- 239000000203 mixture Substances 0.000 claims abstract description 5
- 238000010276 construction Methods 0.000 claims description 11
- -1 polyethylene Polymers 0.000 claims description 11
- TZCXTZWJZNENPQ-UHFFFAOYSA-L barium sulfate Chemical compound [Ba+2].[O-]S([O-])(=O)=O TZCXTZWJZNENPQ-UHFFFAOYSA-L 0.000 claims description 8
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims description 5
- 239000004677 Nylon Substances 0.000 claims description 4
- 239000004698 Polyethylene Substances 0.000 claims description 4
- 239000004743 Polypropylene Substances 0.000 claims description 4
- WMWLMWRWZQELOS-UHFFFAOYSA-N bismuth(III) oxide Inorganic materials O=[Bi]O[Bi]=O WMWLMWRWZQELOS-UHFFFAOYSA-N 0.000 claims description 4
- HQQADJVZYDDRJT-UHFFFAOYSA-N ethene;prop-1-ene Chemical group C=C.CC=C HQQADJVZYDDRJT-UHFFFAOYSA-N 0.000 claims description 4
- 229920001778 nylon Polymers 0.000 claims description 4
- 229920000573 polyethylene Polymers 0.000 claims description 4
- 229920001155 polypropylene Polymers 0.000 claims description 4
- 229920002635 polyurethane Polymers 0.000 claims description 4
- 239000004814 polyurethane Substances 0.000 claims description 4
- 229920000915 polyvinyl chloride Polymers 0.000 claims description 4
- 239000004800 polyvinyl chloride Substances 0.000 claims description 4
- 229910000014 Bismuth subcarbonate Inorganic materials 0.000 claims description 3
- MGLUJXPJRXTKJM-UHFFFAOYSA-L bismuth subcarbonate Chemical compound O=[Bi]OC(=O)O[Bi]=O MGLUJXPJRXTKJM-UHFFFAOYSA-L 0.000 claims description 3
- 229940036358 bismuth subcarbonate Drugs 0.000 claims description 3
- 239000007788 liquid Substances 0.000 claims description 3
- 239000000945 filler Substances 0.000 claims 4
- 239000004033 plastic Substances 0.000 description 7
- 229920003023 plastic Polymers 0.000 description 7
- 238000001125 extrusion Methods 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 3
- 239000004810 polytetrafluoroethylene Substances 0.000 description 3
- 238000007664 blowing Methods 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 229920006362 Teflon® Polymers 0.000 description 1
- 150000001621 bismuth Chemical class 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 229920001971 elastomer Polymers 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000000049 pigment Substances 0.000 description 1
- 229920001169 thermoplastic Polymers 0.000 description 1
- 239000004416 thermosoftening plastic Substances 0.000 description 1
- 239000012780 transparent material Substances 0.000 description 1
- 125000000391 vinyl group Chemical group [H]C([*])=C([H])[H] 0.000 description 1
- 229920002554 vinyl polymer Polymers 0.000 description 1
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
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
Definitions
- This invention relates generally to a radio graphic opaque medical tube, and more specifically to catheters cannulae and other similar tubes which are introduced into the body cavity during the medical procedures.
- Catheters and like cylindrical tubes for introduction to the body cavity are presently manufactured of rubber, vinyl and other thermoplastic materials. Extrusion of such plastic materials is widely employed because of the economies of production.
- Recently, such tubes have been constructed with an X-ray opaque stripe extending throughout the length of the tube so that by directing a beam of X-rays through the body of the patient, the relative position of the catheter will appear on the fluoroscope or X-ray film.
- the stripe may include any suitable X-ray opaque pigment such as one of the bismuth salts.
- the list of following U.S. patents discloses a wide variety of medical tube constructions having radiopaque properties.
- French Certificate de Utilite No. 2,188,448 describes a multi-layer tubing construction in which one of the materials is. radiopaque.
- the catheter may have incorporated therein rods or wires.
- U.S. 3,19072W of Alley, et al discloses a catheter having a X-ray opaque line embedded longitudinally therein with the opaque line being interrupted by openings in the catheter.
- the prior art does not disclose a catheter in which one or more stripes of radiopaque material are totally encapsulated within the catheter material, so as to prevent a contact between the radiopaque material and either liquid flowing through the catheter or the tissue surrounding the catheter upon insertion into the body of the patient.
- the present invention is particularly directed to medical tubes formed of a suitable flexible material and including .an integral stripe portion containing radioopaque material.
- the tubing is coextruded of a physiologically inert flexible waterproof thermoplastic.
- the material may be transparent, translucent or opaque depending on the application desired.
- Encapsulated and coextruded within the body of the tubing are one or more stripes of radiopaque material extending longitudinally along the length of the tubing. In an embodiment where more than one stripe is utilized, the stripes are .disposed coaxially from each other. Each stripe, preferably occupies an area not greater than 90° of the circumference of the tubing, in order to minimize the use of radiopaque material.
- stripes of greater width are encompassed within the scope of the invention, and may extend anywhere up to 160° of the circumference ⁇ f the tubing. In one embodiment, each stripe occupies approximately 90° of the circumference of the tubing, with the stripes disposed approximately 180° from the other.
- a multiplicity of radiopaque stripes are disposed within the tubing, with each stripe occupying a cross-sectional area of approximately. 45o of the circumference of the tubing.
- a number of stripes are utilized in order to provide sufficient radiopaque properties to the tubing.
- a triad of stripes equally spaced from each other and each occupying approximately 90° of the circumference of the tubing are disposed within the tubing.
- the previously mentioned radiopaque material of which the stripes are composed comprises between 10 and 30 percent bismuth trioxide by weight, mixed with a clear plastic material and coextruded into the wall of the tubing. Equivalent quantities of barium sulphate or bismuth subcarbonate may also be utilized. It is particularly important, however, that a high concentration of" radiopaque material be containedwithin the stripe, in order to make it sufficiently visible under X-ray.
- the tubing itself may be constructed of polytetrafluoroethylene, polyfluorinated ethylene/propylene, polyvinylchloride, nylon, polyethylene, polyurethane or polypropylene.
- the plastic material in which the radiopaque material is intermixed may also comprise any one of these materials.
- the above-listed catheters are preferably made by an extrusion procedure, although other commonly known manufacturing methods may be used.
- a multi-orifice tubular extrus on d e is f tted to a double screw extrusion machine or similar device equipped with means for blowing air into the resulting extruded tube through a central opening in the die.
- the tubular die has a major orifice which is substantially circular in cross-section, formed between the inner wall and outer wall and also has one or more minor orifices which may be substantially circular in cross-section or any other desired shape.
- the plastic material to create the tube is extruded through the.
- the catheter should have substantially a uniform wall thickness throughout its length.
- Such uniformity in wall thickness is obtained by extruding plastic material through the die in varying quantities per unit time, and at the same time, coordinating the rate of withdrawing the tube away from the die, and also introducing air through the die opening so that the air blowing and withdrawal is coordinated with the change in rate of- extru- sion of plastic material to maintain a substantially constant wall thickness.
- FIGURE 1 of the drawings is a side view, partially broken away, of an improved radiopaque medical tubing construction.
- FIGURE 2 of the drawings is a cross-sectional view of an improved medical tubing showing in particular a stripe of radiopaque material encapsulated within the wall of the tubing.
- FIGURE 3 of the drawings is a cutaway view of the improved radiopaque medical tubing shown in FIGURE 1 showing in particular a pair of oppositely disposed stripes of radiopaque material each occupying a portion of the circumference of the tubing, of less than 90°.
- FIGURE 4 of the drawings is a cross-sectional view of an improved radiopaque medical tubing construction showing in particular a triad of radiopaque stripes encapsulated within the wall of the tubing.
- FIGURE 5 of the drawings is a cross-sectional view of an improved radiopaque medical tubing construction showing in particular a quartet of stripes of radiopaque material radially disposed and encapsulated within the walls of the tubing.
- FIGURE 6 of the drawings is a cross-sectional view of an improved radiopaque medical tubing construction showing in particular a single stripe of radiopaque material occupying a cross-sectional portion of approximately 160o of the circumference of the tubing and encapsulated within the wall of the tubing.
- FIGURE 7 of the drawings is a cross-sectional view of an improved radiopaque medical tubing construction showing in particular a sextet of radiopaque stripes, radially disposed and encapsulated within the walls of the tubing.
- improved medical tubing construction 10 comprises a tubular portion 12 constructed of a physiologically inert flexible waterproof thermoplastic material. Encapsulated within the wall 14 of the tubular portion 12 are stripes 16 and 18 of radiopaque material which extend coaxially along a tubular portion 12, in substantially parallel alignment with axis a-a. As best seen in FIGURES 2 and 3 of the drawings, medical tubing 12 may have a single stripe 16 or a pair of stripes 16 and 18 disposed within the wall 14 of tubing 12.
- Stripes 16 and 18 occupy a cross-sectional area of less than 90o of the circumference of tubing 12 in order to provide, as best seen in FIGURE 1, visibility through the window portions 20 and 22 of tubing 12, when tubing 12 is constructed of a transparent material. This is particularly important when medical tubing 10 is used as a catheter, in that the flashback of blood may be observed through the wall of tubing 12.
- a single stripe of less than 90° of the circumference of the tubing 12 may be utilized.
- a pair of. stripes each occupying 90° or less of the circumference of tubing 12 may be seen in FIGURE 3.
- a triad of stripes 16, 18 and 24 may be encapsulated coaxially within tubing' 12.
- stripes 16 and 18 and 24 each occupy less than 45° of the cross-sectional area of tubing 12, but combine to provide the desired degree of radiopacity.
- Stripes 16, 18 and 24 may be round, square rectangular or any shape required.
- a quartet of stripes 16, 18, 24 and 26 may be utilized.
- a sextet of stripes 16, 18, 24, 26, 28 and 30 may be encapsulated within the wall 14 of tubing 12.
- the prefecred embodiment of the invention may be seen in FIGURES 1 and 3 in which a pair of radiopaque stripes are coaxially positioned 180° apart from each other.
- radiopaque properties of the stripes themselves are enhanced radiopaque properties of the stripes themselves.
- an increased degree of loading of radiopaque material must be encapsulated within the tubing.
- a mixture of between 10 and 30% by weight bismuth trioxide, barium sulphate, or bismuth subcarbonate intermixed with physiologically inert thermoplastic material and encapsulated within the tubing provides the desired degree of radiopacity.
- between 12% and 24% of the aforementioned radiopaque materials (bismuth trioxide or barium sulphate) by weight pro- vide optimum manufacturing and radiopaque properties.
- Medical tubing 12 may be constructed of such physiologically inert transparent flexible waterproof thermoplastic materials as polytetrafluoroethylene, polyfluorinated ethylene/propylene, polyvinylchloride, nylon, polyethylene, polyurethane or polypropylene.
- polytetrafluoroethylene Teflon®
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Materials For Medical Uses (AREA)
- Storage Of Fruits Or Vegetables (AREA)
- Food Preservation Except Freezing, Refrigeration, And Drying (AREA)
- Measurement Of Radiation (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US17257380A | 1980-07-28 | 1980-07-28 | |
| US172573 | 1980-07-28 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EP0056394A1 EP0056394A1 (en) | 1982-07-28 |
| EP0056394A4 true EP0056394A4 (en) | 1984-07-25 |
Family
ID=22628278
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP19810902089 Withdrawn EP0056394A4 (en) | 1980-07-28 | 1981-06-19 | IMPROVED MEDICAL TUBES OPAQUE TO RADIATION. |
Country Status (5)
| Country | Link |
|---|---|
| EP (1) | EP0056394A4 (enrdf_load_stackoverflow) |
| JP (1) | JPS57501165A (enrdf_load_stackoverflow) |
| DK (1) | DK139482A (enrdf_load_stackoverflow) |
| NO (1) | NO821022L (enrdf_load_stackoverflow) |
| WO (1) | WO1982000413A1 (enrdf_load_stackoverflow) |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS62101261A (ja) * | 1985-10-28 | 1987-05-11 | テルモ株式会社 | 医療器具導入用チユ−ブおよびそれを備えた医療器具導入用組立体 |
| EP0245211A1 (en) * | 1986-03-04 | 1987-11-11 | HOECHST ITALIA SUD S.p.A. | Kidney-ureter catheter unit particularly adapated to evacuate crumbled calculi |
| DE3942112A1 (de) * | 1989-12-20 | 1991-06-27 | Braun Melsungen Ag | Medizinische vorrichtung mit einem oligodynamisch wirkenden material |
| IE70756B1 (en) * | 1990-04-11 | 1996-12-30 | Becton Dickinson Co | Radiopaque optically transparent medical tubing |
| US5102401A (en) * | 1990-08-22 | 1992-04-07 | Becton, Dickinson And Company | Expandable catheter having hydrophobic surface |
| US6729334B1 (en) * | 1994-06-17 | 2004-05-04 | Trudell Medical Limited | Nebulizing catheter system and methods of use and manufacture |
| WO1999048548A1 (en) * | 1998-03-23 | 1999-09-30 | Medtronic, Inc. | Catheter having extruded radiopaque stripes embedded in soft tip and method of fabrication |
| US6200338B1 (en) * | 1998-12-31 | 2001-03-13 | Ethicon, Inc. | Enhanced radiopacity of peripheral and central catheter tubing |
| US6911017B2 (en) | 2001-09-19 | 2005-06-28 | Advanced Cardiovascular Systems, Inc. | MRI visible catheter balloon |
| IN2014DN07117A (enrdf_load_stackoverflow) * | 2012-03-09 | 2015-04-24 | Clearstream Tech Ltd | |
| US9750928B2 (en) | 2013-02-13 | 2017-09-05 | Becton, Dickinson And Company | Blood control IV catheter with stationary septum activator |
| CA2921413C (en) | 2013-08-28 | 2023-08-01 | Clearstream Technologies Limited | Apparatuses and methods for providing radiopaque medical balloons |
| CN103497463B (zh) * | 2013-10-23 | 2015-11-25 | 北京市塑料研究所 | 一种用硫酸钡填充改性的fep导管 |
| US9675793B2 (en) * | 2014-04-23 | 2017-06-13 | Becton, Dickinson And Company | Catheter tubing with extraluminal antimicrobial coating |
| US9789279B2 (en) | 2014-04-23 | 2017-10-17 | Becton, Dickinson And Company | Antimicrobial obturator for use with vascular access devices |
| US10376686B2 (en) | 2014-04-23 | 2019-08-13 | Becton, Dickinson And Company | Antimicrobial caps for medical connectors |
| US10232088B2 (en) | 2014-07-08 | 2019-03-19 | Becton, Dickinson And Company | Antimicrobial coating forming kink resistant feature on a vascular access device |
| US10493244B2 (en) | 2015-10-28 | 2019-12-03 | Becton, Dickinson And Company | Extension tubing strain relief |
| WO2024080004A1 (ja) * | 2022-10-11 | 2024-04-18 | テルモ株式会社 | カテーテル |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3485234A (en) * | 1966-04-13 | 1969-12-23 | Cordis Corp | Tubular products and method of making same |
| US3529633A (en) * | 1967-10-23 | 1970-09-22 | Bard Inc C R | X-ray opaque tubing having a transparent stripe |
| US4027659A (en) * | 1975-11-21 | 1977-06-07 | Krandex Corporation | Radiographic opaque and conductive stripped medical tubes |
| GB1533204A (en) * | 1976-09-07 | 1978-11-22 | Leveen H | Flexible tubing |
| GB2016482A (en) * | 1978-03-17 | 1979-09-26 | Baxter Travenol Lab | Biocompatible silicone-organic thermoplastics-containing compositions |
| EP0033659A2 (en) * | 1980-02-04 | 1981-08-12 | Teleflex Incorporated | Medical-surgical catheter |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2447127A (en) * | 1944-01-19 | 1948-08-17 | Landauer Fred | Electric treatment appliance |
| US2857915A (en) * | 1956-04-02 | 1958-10-28 | David S Sheridan | X-ray catheter |
| BE556940A (enrdf_load_stackoverflow) * | 1956-04-26 | |||
| US2830578A (en) * | 1957-01-31 | 1958-04-15 | Mark E Degroff | Electro-sonic apparatus |
| DE1181826B (de) * | 1959-11-09 | 1964-11-19 | Dr Med Willy Seuss | Elektro-therapeutisches Geraet zur analgetischen Beeinflussung der Nerven und Behandlung von Erkrankungen mittels eines elektrischen Feldes |
| US3070132A (en) * | 1960-04-06 | 1962-12-25 | David S Sheridan | Non-sparking medico-surgical tubes |
| US3219029A (en) * | 1963-03-25 | 1965-11-23 | Groff De | Remote control medical therapy instrument |
| US3642008A (en) * | 1968-09-25 | 1972-02-15 | Medical Plastics Inc | Ground electrode and test circuit |
| US3605750A (en) * | 1969-04-07 | 1971-09-20 | David S Sheridan | X-ray tip catheter |
| US3699389A (en) * | 1970-11-19 | 1972-10-17 | Us Health Education & Welfare | Patient electrode isolation |
| US3946743A (en) * | 1972-01-06 | 1976-03-30 | Medical Research Laboratories, Inc. | Defibrillating electrode |
| US3814105A (en) * | 1972-03-01 | 1974-06-04 | Physio Control Corp | Portable defibrillators including rotary solenoid relays for energy transfer and dumping |
| US3894532A (en) * | 1974-01-17 | 1975-07-15 | Acupulse Inc | Instruments for transcutaneous and subcutaneous investigation and treatment |
| US4109223A (en) * | 1975-09-29 | 1978-08-22 | Ndm Corporation | Multiple choke assembly |
-
1981
- 1981-06-19 WO PCT/US1981/000846 patent/WO1982000413A1/en not_active Application Discontinuation
- 1981-06-19 EP EP19810902089 patent/EP0056394A4/en not_active Withdrawn
- 1981-06-19 JP JP56502521A patent/JPS57501165A/ja active Pending
-
1982
- 1982-03-26 DK DK139482A patent/DK139482A/da not_active IP Right Cessation
- 1982-03-26 NO NO821022A patent/NO821022L/no unknown
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3485234A (en) * | 1966-04-13 | 1969-12-23 | Cordis Corp | Tubular products and method of making same |
| US3529633A (en) * | 1967-10-23 | 1970-09-22 | Bard Inc C R | X-ray opaque tubing having a transparent stripe |
| US4027659A (en) * | 1975-11-21 | 1977-06-07 | Krandex Corporation | Radiographic opaque and conductive stripped medical tubes |
| GB1533204A (en) * | 1976-09-07 | 1978-11-22 | Leveen H | Flexible tubing |
| GB2016482A (en) * | 1978-03-17 | 1979-09-26 | Baxter Travenol Lab | Biocompatible silicone-organic thermoplastics-containing compositions |
| EP0033659A2 (en) * | 1980-02-04 | 1981-08-12 | Teleflex Incorporated | Medical-surgical catheter |
Also Published As
| Publication number | Publication date |
|---|---|
| EP0056394A1 (en) | 1982-07-28 |
| WO1982000413A1 (en) | 1982-02-18 |
| DK139482A (da) | 1982-03-26 |
| JPS57501165A (enrdf_load_stackoverflow) | 1982-07-08 |
| NO821022L (no) | 1982-03-26 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
Free format text: ORIGINAL CODE: 0009012 |
|
| AK | Designated contracting states |
Designated state(s): AT CH DE FR GB LU NL SE |
|
| 17P | Request for examination filed |
Effective date: 19820712 |
|
| STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN |
|
| 18D | Application deemed to be withdrawn |
Effective date: 19850103 |
|
| RIN1 | Information on inventor provided before grant (corrected) |
Inventor name: CHESTER, BRUCE ELDRIDGE |