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
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/02—Access sites
  • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
• • 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
  • A61M2205/82—Internal energy supply devices
  • A61M2205/8206—Internal energy supply devices battery-operated

Definitions

• the present invention relates to catheters intended to be implanted in the body of patients so as to be able to practice perfusions, and more particularly an externalized catheter closed with sealed access.
• Catheters have long been implantable under the skin of the patient and the entrance to which is constituted by an "access site".
• the latter is generally presented in the form of a rigid chamber provided with a septum located just under the patient's skin.
• the doctor or nurse will pinpoint the location of the septum by probing so that the infusion needle can be entered.
• the septum is made of a material which is easily penetrated by the infusion needle, but which regains its tightness as soon as the needle is withdrawn.
• the septum must be replaced after a number of infusions of the order of several hundred, since the large number of infusions performed weakens it and causes it to lose its tightness.
• a leak in the septum, or a displacement of the infusion needle during an infusion can be the cause of a subcutaneous leak.
• the use of an aggressive drug in the infusion product can also be dangerous for the patient due to the needle passing through the skin.
• the invention therefore aims to provide a sealed external catheter presenting no risk of infection like an open external catheter.
• Another object of the invention is to produce an externalized catheter comprising one or more conduits each terminated by a self-healing septum.
• Yet another object of the invention is to provide a catheter externalized to several conduits, one of which contains a support for transmitting signals for controlling the perfusion carried out using another conduit.
• an externalized catheter comprising an internal part implantable in the patient's body and a part external to the patient, through which can penetrate a needle or other instrument making it possible to practice an infusion, a sampling or any other intervention.
• the external part being provided at its free end with at least one sealed stopper made of a material which can be crossed, in a sealed and repeated manner, by said instrument.
• the catheter can comprise several conduits each being closed in its part external to the patient, by a septum which can be crossed by an infusion needle.
• FIG. 1 represents the catheter of the invention with its sleeve and the septum at the external end
• Figure 2 is a sectional view of the outer end of the catheter of the invention
• Figure 3 shows a catheter with several conduits
• Figure 4 shows a catheter with optical fibers and sensors
• Figure 5 shows a two-line catheter, one of which contains optical fibers for the transmission of signals supplied by a sensor for monitoring the perfusion in progress.
• the catheter of the invention comprises a part 10 implanted in the body of the patient, generally in a blood vessel.
• the catheter passes through the patient's skin by means of an anchoring sleeve 14 and ends in an external part 12.
• This external part comprises at its end a sealed plug 16 comprising a septum which is self-healing by a known material such as silicone through which the infusion needle is inserted to deliver a drug solution to the patient.
• the plug 16 is located a few centimeters from the sleeve 14. It can be removable, which makes it possible to replace it and also to adjust the length of the external part 12 of the catheter after its implantation or to facilitate the procedure for introducing the catheter, for example in the case percutaneous intravenous access.
• the plug 16 is preferably provided with fins 18, forming a flat base.
• Figure 2 shows a section through the end of the outer part 12 of the catheter.
• the stopper 16 is composed of a septum 20 through which the infusion needle is pressed.
• the septum 20 is extended by a connector housing 22 which serves as a reservoir for collecting the perfusion liquid.
• the whole is inserted into the catheter.
• Two circular threads of the plug 16 allow its adjustment inside the catheter.
• a sleeve 26 (different from the anchoring sleeve 14), with a conical internal profile makes it possible to tighten the housing 22 firmly inside the catheter and thus to ensure the tightness of the assembly.
• the catheter according to the invention can comprise several conduits or lumens allowing several infusions or independent interventions.
• the catheter of Figure 3 has a portion 10 implanted in the patient's body.
• a sleeve 14 allows the patient's epidermis to pass through.
• the catheter and in particular its part 10 comprising three conduits or lumen, the external part comprises three sealed plugs or septum 32 located at the end of the three external parts 34 which are the extension of the three conduits of the catheter.
• the three conduits being independent and equivalent to three catheters, they may have different diameters, suitable for the infusion or the intervention which it is desired to practice by the septum at the end of said conduit.
• FIG. 4 represents a particular embodiment of the invention.
• the catheter of FIG. 4 does indeed have an internal part 10 implanted in the patient's body, a sleeve 14 for crossing the skin and an external part 40 provided with a tight plug or septum at its end.
• one of the conduits (or lumen) of the catheter is used to pass one or more optical fibers 44.
• the optical fibers 44 which can be removable, make it possible to visualize, thanks to an appropriate visualization device (not shown), the patient's vascular status, to identify thrombosis, or may be used to transmit signals to / from receiving signals from a monitoring device located at the distal end of the catheter.
• Another conduit or lumen can be used to pass two wires 46 leading, at the other end of the catheter, to a sensor.
• a sensor can, thanks to an appropriate monitoring device, be used to measure or analyze certain physiological constituents such as the oxygen level in the blood, the calcium level, etc.
• FIG. 5 An exemplary embodiment of a catheter with two conduits is illustrated in FIG. 5.
• One of the conduits is terminated, at its end external to the patient at the outlet of the sleeve 14, by a self-healing septum 50.
• a second conduit containing optical fibers is terminated by a tip 52 which reveals the connection 54 of the optical fibers of the conduit.
• a sectional magnification of the distal end 56 of the catheter is also shown in Figure 5.
• the conduit responsible for injecting the drug substance into the patient's body has an opening 58 for the flow of the substance.
• the second conduit separated from the first conduit, contains one or more optical fibers 60 directly accessing a device 62 containing a photovoltaic cell of the gallium arsenide type and a miniaturized optical generator, a device itself connected to a sensor 64 of the piezo type. electric.
• the supply of energy to the device 62 and to the sensor 64 can thus be carried out by lighting the photovoltaic cell using optical fibers.
• the signals supplied by the sensor 64 are transformed into optical signals and transmitted by the optical fibers to the end where they are collected and analyzed so as to modify the parameters of the perfusion if necessary.
• the catheter according to the invention can be used for any drug infusion or not, as well as for withdrawing a fluid from the human body or for carrying out any examination or any appropriate intervention. It combines the advantages of the implantable access site and the externalized catheter without having the disadvantages. Thus its sealed access, even during an operation of connection to a perfusion line, minimizes the risks of infection. This advantage is further reinforced by the absence of intradermal puncture. Extravasation is unlikely due to an easy and secure connection between the catheter and the infusion line. In addition, the septum presents no difficulty in being identified and then pricked. Many advantages ensue from the present invention such as:
• a possible occlusion of the catheter can be eliminated by the introduction of a stylet, mandrel or other suitable device inside the catheter, through the septum or after removal of the septum,
• the septum can be replaced in the event of damage without resorting to surgical intervention, while leaving the catheter in place.

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• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
• Biomedical Technology (AREA)
• Gastroenterology & Hepatology (AREA)
• Pulmonology (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biophysics (AREA)
• Hematology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Applications Claiming Priority (3)

Publications (1)

Family

ID=9429384

Family Applications (1)

Country Status (7)

Family Cites Families (5)

• 1992
  • 1992-04-29 FR FR9205307A patent/FR2690624B1/fr not_active Expired - Fee Related
• 1993
  • 1993-04-28 EP EP93911830A patent/EP0606416A1/de not_active Withdrawn
  • 1993-04-28 WO PCT/FR1993/000412 patent/WO1993021972A1/fr not_active Application Discontinuation
  • 1993-04-28 CA CA 2111674 patent/CA2111674A1/fr not_active Abandoned
  • 1993-04-28 JP JP5518997A patent/JPH06507825A/ja active Pending
  • 1993-04-28 AU AU42873/93A patent/AU673839B2/en not_active Ceased
  • 1993-12-22 NO NO934780A patent/NO934780L/no unknown

Non-Patent Citations (1)

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