WO1998036789A1 - Etiquette informative dechirable pour appareils medicaux - Google Patents

Etiquette informative dechirable pour appareils medicaux Download PDF

Info

Publication number
WO1998036789A1
WO1998036789A1 PCT/US1998/001069 US9801069W WO9836789A1 WO 1998036789 A1 WO1998036789 A1 WO 1998036789A1 US 9801069 W US9801069 W US 9801069W WO 9836789 A1 WO9836789 A1 WO 9836789A1
Authority
WO
WIPO (PCT)
Prior art keywords
label
medical device
shaft
tubular shaft
opening
Prior art date
Application number
PCT/US1998/001069
Other languages
English (en)
Inventor
William Howard Treadaway
Original Assignee
C.R. Bard, 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 C.R. Bard, Inc. filed Critical C.R. Bard, Inc.
Publication of WO1998036789A1 publication Critical patent/WO1998036789A1/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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/92—Identification means for patients or instruments, e.g. tags coded with colour
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6063—Optical identification systems

Definitions

  • the present invention relates generally to medical devices, and relates more specifically to a novel arrangement for affixing an information label to a medical device.
  • an ideal label will thus satisfy the following criteria: (1) the label must be of sufficient size to hold the necessary information; (2) the label must be positioned on the device such that the information on the label is readily visible to the healthcare personnel using the device; (3) the label must be affixed in such a way that it will not inadvertently become separated from the device; (4) the label must be able to be removed quickly and easily in the event of an emergency; (5) once removed, the label must not leave an adhesive residue or other nonsterile remnant; and (6) the label must be easy to apply without interfering with, or being damaged by, the assembly, sterilization, and packaging processes involved in manufacturing the device. In addition, it would be advantageous if the label were inexpensive to manufacture and easy to apply to the device. Thus there is a need for a means for providing information in conjunction with a medical device which meets the foregoing objectives.
  • the present invention comprises a label for providing information in conjunction with a medical device, such as a catheter, drain, stent, or the like.
  • the label provides a sufficiently large, flat surface to hold instructional information and is positioned on the medical device such that the information on the label is readily visible to the healthcare personnel using the device.
  • the label can be removed quickly and easily in the event of an emergency, and once removed, will not leave an adhesive residue or other nonsterile evidence of its presence.
  • the label is easy to apply to a medical device and does not interfere with, or become damaged by, the assembly, sterilization, and packaging processes involved in manufacturing the device.
  • the label is inexpensive to manufacture and easy to apply to the device.
  • the present invention relates to a label for a medical device comprising a tubular shaft with obstructions at both ends of the shaft.
  • An information-bearing label is disposed on the tubular shaft, the shaft extending through the central opening of the label.
  • the central opening of the label has a diameter which is less than the outer diameter of the obstruction, so that the label is prevented from sliding off the shaft by the obstruction.
  • the tubular shaft comprises an inflation lumen of a catheter, and a cap fits onto the free end of the inflation lumen to retain a valve in place on the end of the inflation lumen.
  • the label is provided with a perforation line to facilitate tearing the label away from the catheter in the event of a medical emergency.
  • the invention in a second aspect relates to a label for a medical device comprising a tubular shaft with no obstructions to prevent a label from sliding off a free end of the shaft.
  • An information-bearing label is disposed on the tubular shaft, the shaft extending through the central opening of the label.
  • the label has a plurality of radial slits extending from its inner circumference, dividing the portion of the label immediately adjacent the central opening into a number of discrete tabs.
  • the inner circumference of the label is smaller than the circumference of the shaft upon which it is to be applied, and the circumference of the circle along which the radial slits terminate is greater than the circumference of the shaft.
  • the label is provided with a perforation line to facilitate tearing the label away from the catheter in the event of a medical emergency.
  • Yet another object of the present invention is to provide a label for conveying information to a healthcare provider of a medical device which is securely affixed to the device but can be removed quickly and easily in the event of an emergency.
  • Still another object of the present invention is to provide an arrangement for affixing an instructional label to a medical device which can be quickly and easily removed in the event of an emergency.
  • FIG. 1 is a front view of a first embodiment of a tear-away information label for use on a medical device according to the present invention.
  • FIG. 2 is an exploded isometric view of a catheter with the tear-away information label of FIG. 1.
  • FIG. 3 is a view of the catheter of FIG. 2 showing the components assembled and the label affixed.
  • FIG. 4 is a front view of a second embodiment of a tear-away information label for use on a medical device according to the present invention.
  • FIG. 5 is a perspective view of a medical device with information label of FIG. 4.
  • FIG. 1 shows a tear-away information label 10 according to a preferred embodiment of the invention.
  • the label 10 of the disclosed embodiment is in the form of a ring and has an inner circumference 11 defining a central opening 12.
  • Indicia 14 are printed on both faces of the label 10.
  • the label 10 bears the indicia "INFLATE WITH 10CC STERILE WATER.”
  • a perforation line 16 extends radially across one side of the label 10.
  • the label 10 is comprised of TyvekTM, a spun- bonded olefin produced by DuPont. Another suitable material is KimduraTM, a multi-ply biaxially oriented polypropylene film produced by Kimberly-Clark. Other suitable materials will readily be identified by those skilled in the art.
  • FIGS. 2 and 3 show a urological catheter 20.
  • the catheter of the disclosed embodiment is comprised of silicone or latex, though other suitable materials can also be used and will be readily identified by those skilled in the art.
  • the catheter 20 includes a catheter body 21 comprising a drainage lumen 22 having a proximal end 24 and a distal end 26.
  • the proximal end 24 of the catheter 20 flares to form a connector 28 by which the drainage lumen 22 can be coupled by way of an interference fit to a tubing (not shown) to place the catheter in fluid communication with a suitable container, such as a urinary drainage bag.
  • the drainage lumen 22 is tapered adjacent its distal end 26, and the distal end is rounded to minimize trauma to the patient.
  • Ports or eyes 30 are defined adjacent the distal end 26 of the drainage lumen 22 to place the drainage lumen in fluid communication with the environment surrounding the distal end of the catheter.
  • a balloon 32 surrounds the drainage lumen 22 proximal to the ports 30.
  • An inflation lumen 36 branches from the drainage lumen 22 and has a free end 37. The inflation lumen 36 extends obliquely from the drainage lumen 22 and then angles toward the proximal end 24 of the drainage lumen until the inflation lumen extends substantially "parallel to the drainage lumen.
  • a passage 38 extends the length of the inflation lumen
  • a valve 40 is positioned within the free end 37 of the inflation lumen 36 and has a port in fluid communication with the passage 38.
  • the valve 40 includes a nipple 41 which fits within the outer end of the passage 38 of the inflation lumen.
  • the outer diameter of the nipple 41 is slightly larger than the inner diameter of the passage 38 in the inflation lumen 36.
  • the cap 42 has an inner diameter which fits snugly over the distended free end 37 of the inflation lumen 36 such that the free end of the inflation lumen is captured between the nipple 41 of the valve and the inner circumference of the cap 42.
  • the cap 42 has an outer diameter which is larger than the outer diameter of the inflation lumen 36.
  • the label 10 is captured on the inflation lumen 36 with the inflation lumen being received through the central opening 12 of the label.
  • the inner diameter 11 of the label 10 is slightly larger than the outer diameter of the inflation lumen 36 but is smaller than the outer diameter of the cap 42. Thus the label 10 is prevented by the cap 42 from sliding off the free end 37 of the inflation lumen 36.
  • the body 21 of the catheter 20 consists of the drainage lumen 22, the balloon 32, and the inflation lumen 36.
  • the catheter body 21 is formed by a conventional method well known to those skilled in the art in which the catheter body is built up in layers on a mandrel by a sequence of steps which involves dipping the mandrel into liquid latex. Since this process is conventional and well-known, it will not be explained in detail. In addition, other methods of manufacturing the catheter body, such as molding, can be employed, as the precise method of manufacture is not a part of the present invention.
  • an information label 10 is placed over the inflation lumen 36.
  • the valve 40 and cap 42 are then installed onto the free end of the inflation lumen 36 in a conventional manner, capturing the label on the inflation lumen.
  • the indicia 14 can comprise a color code to convey information to the user.
  • an orange label can be used to indicate a 16 Fr. catheter, while a light blue label indicates a 24 Fr. catheter.
  • the foregoing arrangement by which the information label 10 is captured on the medical device by enlargements or blockages at both ends of a tubular structure works well with catheters and other such devices that have a tubular section blocked off at both ends.
  • FIG. 4 illustrates an alternate embodiment of an information label 50 which can be used in such applications and which relies on a friction fit to retain the label on the shaft of a medical device.
  • the label 50 is annular and has an outer circumference 51 and an inner circumference 52 defining a central opening 53.
  • One or more radially extending perforation lines 54 are formed in the label to provide a line of weakness along which the label can be torn to remove it from the medical device.
  • Information 55 is imprinted on the face of the label 50.
  • the label 50 can be color- coded to convey information instead of, or in conjunction with, printed indicia 55.
  • a plurality of radial slits 56 are formed in the label beginning at its inner circumference 52 and radiating outward a short distance.
  • the slits terminate along a circle 57 concentric with the inner circumference 52.
  • the slits divide the portion of the label 50 immediately adjacent the central opening 53 into a number of discrete tabs 58.
  • the diameter of the inner circumference 52 of the label is less than the diameter of the shaft of the device, which in turn is less than the diameter of the circle 57 along which the radial slits 56 terminate.
  • FIG. 5 shows the label 50 mounted to a shaft 60 of a medical device such as a stent, drain, or other structure which lacks blockages at both ends for capturing a label on the shaft.
  • the label 50 is advanced over the free end 62 of the shaft 60 with the shaft being received through the central opening 53 of the label. Because the diameter of the shaft 60 is greater than the diameter of the inner circumference 52 of the label 50, positioning the label on the shaft causes the tabs 58 to deflect outward. The resiliency of the material from which the label 50 is constructed causes the tabs 58 to tend to return to their original orientation, thereby exerting a radially inward force around the periphery of the shaft 60.
  • the angle of the tabs 58 will also resist movement of the label on the shaft in the opposite direction such that the label, once installed, will not easily slide off the free end of the shaft. Should it become necessary to remove the label 50 quickly, the user can simply tear the label along one of the radial lines of perforation 54 to remove it from the device.
  • the tear-away information label described above is suitable for use on Foley catheters; urine collection products such as drainage bags, drainage tubing, and sample ports; suprapubic drains; percutaneous drains; stents; stylets; ureteral catheters; urethral catheters; bladder evacuators; syringes; disposable inflation devices; dilation catheters; filiforms, followers, and bougies; dilators and sounds; guide wires; stone extractors; endoscopic instruments; ureteroscopic instruments; syringe assist irrigation systems for endoscopy procedures; surgical drain systems; infusion catheters; and vena cava filter catheters.
  • tear-away information labels 10, 50 of the disclosed embodiments are shown in the form of annular rings, it will be understood that the invention is not limited to a circular or ring-shaped label.
  • the term “circumference” shall be understood to refer to the external boundary of an object, regardless of its shape, and is not meant to imply a circular shape.
  • the periphery and opening of the label can have any suitable shape.
  • the labels 10, 50 are described as having "central” openings, the invention is not limited to an opening located in the "center” of the label but will be understood to include any opening which is substantially entirely bound by the label.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Pathology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un appareil médical comportant une tige tubulaire et une étiquette informative disposée sur ladite tige. Dans un premier mode de réalisation, la tige comporte des parties élargies à ses deux extrémités, et l'étiquette présente une circonférence intérieure qui est supérieure à la circonférence de la tige mais inférieure à la circonférence des parties élargies. Dans un deuxième mode de réalisation, l'étiquette présente des fentes radiales s'étendant vers l'extérieur à partir de l'ouverture centrale, à une distance prédéfinie, et divisant la partie intérieure de l'étiquette en une pluralité de languettes distinctes. La circonférence intérieure de l'étiquette est inférieure à la circonférence de la tige de l'appareil médical, et la circonférence définie par les extrémités extérieures des fentes radiales est supérieure à la circonférence de la tige. Lorsque l'étiquette est placée au-dessus de l'extrémité libre de la tige d'un appareil médical, les languettes se déforment vers l'extérieur et exercent une force dirigée radialement vers l'intérieur, sur la périphérie de la tige, qui retient l'étiquette sur la tige. Des les modes de réalisation présentés, une ligne de perforation est formée sur l'étiquette pour permettre de séparer l'étiquette de l'appareil médical, en la déchirant, en cas d'urgence médicale.
PCT/US1998/001069 1997-02-19 1998-01-28 Etiquette informative dechirable pour appareils medicaux WO1998036789A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US80285697A 1997-02-19 1997-02-19
US08/802,856 1997-02-19

Publications (1)

Publication Number Publication Date
WO1998036789A1 true WO1998036789A1 (fr) 1998-08-27

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1998/001069 WO1998036789A1 (fr) 1997-02-19 1998-01-28 Etiquette informative dechirable pour appareils medicaux

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1442700A1 (fr) * 2003-01-31 2004-08-04 ERKA. KALLMEYER Medizintechnik GmbH & Co. KG Appareil de mesure de la pression sanguine
WO2005027767A1 (fr) * 2003-09-25 2005-03-31 Itl Healthcare Pty Ltd Trousse medicale et methode associee
US9592375B2 (en) 2006-05-18 2017-03-14 Hyprotek, Inc. Intravascular line and port cleaning methods, methods of administering an agent intravascularly, methods of obtaining/testing blood, and devices for performing such methods
EP3329898A3 (fr) * 2014-09-04 2018-09-05 Corpak Medsystems, Inc. Systèmes gastriques, appareil et procédés associés destinés à être utilisés avec une alimentation entérale
US10076653B2 (en) 2006-05-18 2018-09-18 Hyprotek, Inc. Medical caps and methods of use
US11406793B2 (en) 2016-09-23 2022-08-09 Hollister Incorporated Introduction to self-catheterization kit

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4116227A (en) * 1976-06-28 1978-09-26 Plasco, Inc. Combination catheter venting and urine sample collecting unit and method of making the same
US4619640A (en) * 1984-08-17 1986-10-28 Potolsky Abraham I Blood transfusion connector assembly
US4795429A (en) * 1987-10-28 1989-01-03 Feldstein Marvin A Method and apparatus for use in the control of intravenous medication introduction
US5489275A (en) * 1994-11-14 1996-02-06 Ep Technologies, Inc. Identification ring for catheter
US5531723A (en) * 1994-04-20 1996-07-02 Solazzo; Anthony Ureteral catheter connector adapter

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4116227A (en) * 1976-06-28 1978-09-26 Plasco, Inc. Combination catheter venting and urine sample collecting unit and method of making the same
US4619640A (en) * 1984-08-17 1986-10-28 Potolsky Abraham I Blood transfusion connector assembly
US4795429A (en) * 1987-10-28 1989-01-03 Feldstein Marvin A Method and apparatus for use in the control of intravenous medication introduction
US5531723A (en) * 1994-04-20 1996-07-02 Solazzo; Anthony Ureteral catheter connector adapter
US5489275A (en) * 1994-11-14 1996-02-06 Ep Technologies, Inc. Identification ring for catheter

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1442700A1 (fr) * 2003-01-31 2004-08-04 ERKA. KALLMEYER Medizintechnik GmbH & Co. KG Appareil de mesure de la pression sanguine
WO2005027767A1 (fr) * 2003-09-25 2005-03-31 Itl Healthcare Pty Ltd Trousse medicale et methode associee
US9592375B2 (en) 2006-05-18 2017-03-14 Hyprotek, Inc. Intravascular line and port cleaning methods, methods of administering an agent intravascularly, methods of obtaining/testing blood, and devices for performing such methods
US10076653B2 (en) 2006-05-18 2018-09-18 Hyprotek, Inc. Medical caps and methods of use
US11471245B2 (en) 2006-05-18 2022-10-18 Hyprotek, Inc. Intravascular line and port cleaning methods, methods of administering an agent intravascularly, methods of obtaining/testing blood, and devices for performing such methods
EP3329898A3 (fr) * 2014-09-04 2018-09-05 Corpak Medsystems, Inc. Systèmes gastriques, appareil et procédés associés destinés à être utilisés avec une alimentation entérale
US10682286B2 (en) 2014-09-04 2020-06-16 Avent, Inc. Gastric systems, apparatus, and methods for use with enteral feeding
US11406793B2 (en) 2016-09-23 2022-08-09 Hollister Incorporated Introduction to self-catheterization kit

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