WO2015013770A1 - Dispositif pour cathéter - Google Patents

Dispositif pour cathéter Download PDF

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Publication number
WO2015013770A1
WO2015013770A1 PCT/AU2014/050166 AU2014050166W WO2015013770A1 WO 2015013770 A1 WO2015013770 A1 WO 2015013770A1 AU 2014050166 W AU2014050166 W AU 2014050166W WO 2015013770 A1 WO2015013770 A1 WO 2015013770A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
zone
length
catheter device
zones
Prior art date
Application number
PCT/AU2014/050166
Other languages
English (en)
Inventor
Teresa Kathryn WITHERS
Original Assignee
Withers Teresa Kathryn
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
Priority claimed from AU2013902908A external-priority patent/AU2013902908A0/en
Application filed by Withers Teresa Kathryn filed Critical Withers Teresa Kathryn
Publication of WO2015013770A1 publication Critical patent/WO2015013770A1/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
    • 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
    • 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
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/062—Measuring instruments not otherwise provided for penetration depth
    • 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
    • A61M2025/0008—Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type

Definitions

  • the present invention relates generally to medical devices and in particular to a catheter device.
  • ventricles The human brain has within it, fluid filled chambers called ventricles.
  • a schematic illustration of the ventricles in the brai is illustrated in Figures 1 and 2, which are an anterior and left lateral view of the brain respectively,
  • the fluid which surrounds and cushions the brain and spinal cord is called cerebrospinal fluid or CSF.
  • CSF cerebrospinal fluid
  • the ventricles are interconnected and are critical in maintaining the structure of the brain and altering pressure within th brain which is known as the intra- cerebral pressure (ICP).
  • ICP intra- cerebral pressure
  • Intra-ventrieular catheters have been used for more than 20 years to monitor cerebrospinal fluid pressure by connecting them to a pressure transducer. If the pressure is high, it is possible to draw off fluid to decrease the intra-cerebral pressure.
  • the catheters used are typical!)' soft but have a firm, metal stylet which runs through the centre of the catheter.
  • the stylet is typically withdrawal once the catheter is in the correct position.
  • FIG. 3 The process of placement of an intra-ventricular catheter is illustrated in Figures 3 to 6.
  • an incision 10 is typically made in the skin of the patient's head, generally adjacent the swelling of the brain tissue 1 1.
  • a burr hole 12 is drilled into the bone of the patient's skull to create an opening for the catheter as illustrated in Figure 4.
  • the skin of the head is spread using retractors and a catheter is inserted manually through the burr hole 12 as illustrated in Figure 5.
  • the medical practitioner must manually insert the catheter 13 such that the lower end of the catheter 13 sits in a ventricle 14.
  • A. pressure transducer 15 is then attached to the outer end of the catheter to monitor the intracranial pressure as illustrated in Figure 6.
  • One problem at present is that placing an intra-ventricular catheter in the correct location can be difficult.
  • problems such as altered anatomy, for example the ventricles being smaller than anticipated due to raised intracranial pressure, or displacement of ventricles from the normal anatomical position due to a mass effect for example a haematoma, may occur.
  • operators may be tempted to insert the cathete further, hoping to reach the ventricle, which may already have been passed. The result of this can be injury to delicate brai structures,
  • the present invention is directed to a catheter device, which may at least partially overcome at least one of the abovementioned disadvantages or provide the consumer with a useful or commercial choice.
  • the present invention in on form, resides broadly in a catheter device including a tubular body with external markings defining at least two zones to indicate a depth of insertion of the catheter,
  • the intent of the present invention is to provide a simple, universally understood device allowing an operator to appreciate the depth to which a catheter, particularly an intraventricular catheter has been inserted. Whilst the numbering system may be used, the orientation of the catheter may mean that the numbering system is obscured from view of the operator. This fact coupled with the small size of the catheter meaning that any numbering system used will be printed in very small print, means that using a numbering system to indicate depth of insertion is not an ideal solution to the problem,
  • the catheter device of the present invention can be provided for an type of catheter but is particularly well adapted to use in cerebral intraventricular catheters.
  • the tubular body will have external markings defining at least two zones to indicate a depth of inserti on. Graduations or l i nes or other types of measurements may be provided but where provided, they will be provided in addition to the zones. [0015] Preferably, the zones will be defined over a length of the catheter.
  • the external markings are easily vi sible from all sides or angles of view of the catheter. For this reason, it is preferred that, the external markings are provided continuously over a particular length of the catheter as well as continuously around the external surface of the catheter over that length..
  • each zone is provided with an. external marking that is a particular colour.
  • each zone is preferably a continuous, coloured portion of the external surface of the catheter or applied to the external surface of the catheter.
  • the zones are adjacent and preferably immediately adjacent one another. There may be a demarcation line or area provided between adjacent zones but typically, the zones will simply be adjacent one another and one zone will terminate where the next zone starts.
  • Incremental measurement indicia may be provided in addition to the zones, either within each zone or over the length of the catheter. That is, the measurement indicia may measure the length of the catheter in that zone or more preferably, the length of the catheter from the forward or insertion end to any one or more points over the length of the catheter.
  • Each zone is typically a block which is continuous over its length as well as circumferentially around the outer surface of the catheter,
  • a tip portion may be provided which is not a part of the colouring convention.
  • Thi s tip portion will normally be the base colour of the catheter.
  • the length of the tip portion is normally considered in determining the distance to the transition zone.
  • the tip portion is typicall followed by a gree zone of a particular length which is then followed by a yellow or amber zone of a particular length which is then followed in turn by a red zone of a particular length.
  • the length of the particular zones may differ for different applications.
  • the tip portion (non-coloured) is approximately 3 cm in length
  • the green zone is approximately 4 cm in length
  • the yellow or amber zone is approximately 3 cm in length
  • red zone is approximately 5 cm in length. This particular configuration is particularly useful as an intraventricular cerebral catheter.
  • the number of zones provided on the catheter may vary but three coloured zones are particularly preferred.
  • the colours in the zones may be provided in any way to the catheter.
  • the colours may be provided integral iy with the material used to form the catheter (such as impregnation of a dye or similar) or alternatively, the colour may be provided to an external surface only of the catheter (one method of which is the application of a coloured transfer, coloured ski or coloured adhesive sticker of the appropriate colour or colours to the external surface of the catheter).
  • Figure 1 is an anterior view of the human brain with the location of the ventricles illustrated
  • Figure 2 is a left lateral view of the human brain with the location of the ventricl es illustrated therein.
  • Figure 3 is a schematic illustration, showing the first step of introducing an intraventricular catheter namely forming an incision in the skin of a patient's head.
  • Figure 4 is a schematic illustration of a second step of forming a hole in the skull using a burr.
  • Figure 5 is a schematic illustration of a third step of manually introducing a catheter through the formed hole.
  • Figure 6 is a schematic illustration showing the proper placement of an intraventricular catheter
  • Figure 7 is a schematic illustration of a catheter device according to a preferred embodiment of the present invention.
  • Figures 8 A to 8D are illustrations of the respective lengths of catheter inside a human skull and the various zones of the catheter of the preferred embodiment.
  • Figures 8E to 8L are illustrations of the insertion of the catheter of the preferred embodiment into a human skull .
  • a catheter device 20 is provided.
  • the catheter device 20 includes a tubular body with external markings defining five zones to indicate a depth of insertion of the catheter.
  • each zone i provided with an external marking that is a particular colour.
  • each zone is a continuous, coloured porti on of the external surface of the catheter.
  • the external markings are provided continuousl y over a length of the catheter as well as continuously around the external surface of the catheter over that length.
  • the external markings are therefore easily visibl e from all sides or angles of view of the catheter as well as being viewable from a larger distance than graduations or measurements without coloured zones.
  • the markings can easily be seen by the operator inserting the catheter as well as other observers.
  • the particular colours used are green, yellow or amber and red indicating at least three zones along, the length of the catheter and the location to which the catheter will normally be inserted.
  • each zone is a block which is continuous over its length as well as circumferential ly around the outer surface of the catheter.
  • a tip portion may be provided which is not a part of the colouring convention , This tip portion will normally be the base colour of the catheter .
  • the tip portion 21 is followed by a green zone 22 of a particularly length which is then followed by a yellow or amber zone 23 of a particular length which is then followed in turn by a red zone 24 of a particular length.
  • a green zone 22 of a particularly length which is then followed by a yellow or amber zone 23 of a particular length which is then followed in turn by a red zone 24 of a particular length.
  • a red zone 24 of a particular length.
  • the tip portion is approximately 3 cm in length
  • the green zone i is approximately cm in length
  • the yellow or amber zone is
  • red zone is approximately 5 cm in length. This particular configuration is particularly useful as an. intra-ventricular cerebral catheter,
  • the colours in the zones may be provided in any way to the catheter.
  • the colours may be provided integrally with the material used to form the catheter or
  • the colour may be provided to an external surface only of the catheter
  • the white or base coloured zone is the first 3 cm
  • the green zone is 4 em in length from 3 cm to 7 cm (this is the safe zone and most anteriorly placed intraventricular catheters will enter into the ventricle i this range)
  • the yellow zone is 4 cm in length from 7 cm to 11 cm (this is the caution zone, for parietal catheters insertion to the cautious zone can be acceptable)
  • the red zone is the subsequent 5 cm in length from 11 cm to 36 cm (the danger zone).
  • Figure 8£ shows in detail, the initial insertion of the catheter into the bun " hole formed in the skull .
  • Figure 8F shows the catheter placed at the beginning of the green zone which means that the tip is approximately 3cm within the skull .
  • Figure 8H shows the catheter placed approximately two thirds of the green zone into the skull which means that the tip is approximately 5 -6cm within the skull,
  • Figure 81 shows the catheter placed at the beginning of the yellow zone which means that the tip is approximately 7cm within the skull.
  • Figure 8 J shows the catheter placed approximately two thirds of the yellow zone into the skull which means that the ti is approximately 9-lOcra within the skull.
  • Figures 8 and 81.. show the catheter placed within the red zone which means that approximately 1 1 cm of the catheter is within the skull. At this length, extreme care needs to be taken as a small movement of the catheter can easi iy result in i jury to delicate brain structures.
  • the catheter deviee of the present invention can be applied in any application where successful placement is dependent on depth. This would include but is not limited to intercostal catheters, indwelling urinary .catheters, pig tail catheters, surgical catheters or surgical drainage devices,

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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)

Abstract

L'invention concerne un dispositif pour cathéter comprenant un corps tubulaire muni d'éléments de repérage extérieurs définissant au moins deux zones visant à indiquer une profondeur d'insertion du cathéter.
PCT/AU2014/050166 2013-08-02 2014-08-01 Dispositif pour cathéter WO2015013770A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AU2013902908 2013-08-02
AU2013902908A AU2013902908A0 (en) 2013-08-02 A Catheter Device

Publications (1)

Publication Number Publication Date
WO2015013770A1 true WO2015013770A1 (fr) 2015-02-05

Family

ID=52430765

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/AU2014/050166 WO2015013770A1 (fr) 2013-08-02 2014-08-01 Dispositif pour cathéter

Country Status (1)

Country Link
WO (1) WO2015013770A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2540998A (en) * 2015-08-04 2017-02-08 Phagenesis Ltd Catheter

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4645491A (en) * 1984-03-09 1987-02-24 David Evans Surgical needle
US20020087098A1 (en) * 2000-10-30 2002-07-04 Jun Iwami Medical long object and method for producing the same
US20060052766A1 (en) * 2004-09-08 2006-03-09 Beth Israel Deaconess Medical Center, Inc. Color-coded medical tubes and post-insertion monitoring thereof
US20060149165A1 (en) * 2004-12-15 2006-07-06 Wilson-Cook Medical Inc. Minimally invasive medical device with helical pattern for indicating distance of movement
US20090162530A1 (en) * 2007-12-21 2009-06-25 Orion Industries, Ltd. Marked precoated medical device and method of manufacturing same
US7909797B2 (en) * 2006-09-13 2011-03-22 Wilson-Cook Medical Inc. Medical catheter with stress riser at access port to reduce rupture force

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4645491A (en) * 1984-03-09 1987-02-24 David Evans Surgical needle
US20020087098A1 (en) * 2000-10-30 2002-07-04 Jun Iwami Medical long object and method for producing the same
US20060052766A1 (en) * 2004-09-08 2006-03-09 Beth Israel Deaconess Medical Center, Inc. Color-coded medical tubes and post-insertion monitoring thereof
US20060149165A1 (en) * 2004-12-15 2006-07-06 Wilson-Cook Medical Inc. Minimally invasive medical device with helical pattern for indicating distance of movement
US7909797B2 (en) * 2006-09-13 2011-03-22 Wilson-Cook Medical Inc. Medical catheter with stress riser at access port to reduce rupture force
US20090162530A1 (en) * 2007-12-21 2009-06-25 Orion Industries, Ltd. Marked precoated medical device and method of manufacturing same

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2540998A (en) * 2015-08-04 2017-02-08 Phagenesis Ltd Catheter
US10814125B2 (en) 2015-08-04 2020-10-27 Phagenesis Limited Catheter

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