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®

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• 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)
• Food Preservation Except Freezing, Refrigeration, And Drying (AREA)
• Measurement Of Radiation (AREA)
• Storage Of Fruits Or Vegetables (AREA)

Priority Applications (2)

Applications Claiming Priority (2)

Publications (1)

Family

ID=22628278

Family Applications (1)

Country Status (5)

Cited By (17)

Families Citing this family (2)

Citations (14)

Family Cites Families (6)

• 1981
  • 1981-06-19 WO PCT/US1981/000846 patent/WO1982000413A1/en not_active Application Discontinuation
  • 1981-06-19 JP JP56502521A patent/JPS57501165A/ja active Pending
  • 1981-06-19 EP EP19810902089 patent/EP0056394A4/en not_active Withdrawn
• 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 (14)

Non-Patent Citations (2)

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