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
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/02—Access sites
  • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
• • 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
  • A61M2039/025—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body through bones or teeth, e.g. through the skull
• • 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
  • A61M2039/0261—Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in 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
  • 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
  • A61M2039/0276—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for introducing or removing fluids into or out 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
  • 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
  • A61M2039/0282—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body with implanted tubes connected to the port

Definitions

• the present invention relates to a transcutaneous implanted fluid transfer device, allowing the circulation of a fluid, biological or not, between an organism and an external device.
• the transcutaneous passage of liquids is carried out by means of a catheter temporarily crossing the cutaneous plane through an incision, and possibly having means of temporary fixation on the skin, using adhesives or dressings. This is how liquids can be introduced into or extracted from the body, for example for extra ⁇ bodily circulation, dialysis, administration of infusion fluids or even the extraction of effusions using 'a redon.
• Implantable devices are already known which make it possible to ensure an electrical connection between conductors implanted in the body and external conductors capable of being connected to a source of energy or to an apparatus. In reality, these projects have never passed the experimental stage, in particular because of the risk of rejection as well as the mechanical instability incompatible with the practice of everyday life.
• implants are already known in the form of a plate, intended to be fixed to a bone surface, in particular the temporal or parietal bone, and having a transcutaneous stud comprising, at its external end, fixing means making it possible to receive a prosthesis for aesthetic purposes.
• Such implants made in particular of titanium, are well tolerated, with very reduced risks of infection.
• the present invention proposes to provide a transcutaneous fluid transfer device which can be implanted permanently, and even permanently, to ensure the transfer of a fluid between external means and implanted means, under conditions of strict asepsis and which can be fixed in bodily locations in which it is apparently not possible to implant and implement fluid conduits.
• the invention also aims to achieve such devices in economical conditions with a limited number of parts and easy assembly.
• the subject of the invention is a transcutaneous device for transparent transfer of fluid between an organism and an external device, characterized in that it comprises a substantially flat base, made of a material tolerable by the organism and capable of extending parallel to the skin, in a subcutaneous position, the height of which is sufficiently low to allow easy healing of the cutaneous plane over the base, said base comprising means allowing its attachment to an underlying organic support, for example a bone surface , a transcutaneous abutment capable of being tightly fixed on said base and through the skin through an incision to present an end external to the body, at least one fluid passage extending in the pillar, and having an external mouth opening onto the external surface of the pillar, a valve arranged in the passage, preferably on the outside of the pillar, to maintain a normally closed position preventing the exit of a fluid, possibly present, and the entry of materials or microorgan
• the base has an internal passage extending substantially in its plane, that is to say perpendicular to said pillar, and opening into a nozzle in or on which said implantable conduit can be fixed, and communicating, at its other end, with the substantially perpendicular passage contained in the pillar.
• the implanted conduit or conduits remain constantly parallel to the skin plane in all their parts close to the base without having any elbow oriented transversely to the skin.
• the pillar can be fixed, in a removable manner, on the base with the interposition of a seal, thanks to fixing means capable of extending in the pillar to join the base.
• the base and the implantable conduit (s) being fixed, in a subcutaneous position, on the underlying organic support, the surface of the base intended to receive the pillar being temporarily covered by a protective cap, which allows the skin to heal, after which an incision is made at the part of the base intended to receive the pillar and, after removal of the protective cap, the pillar is fixed to the base through the incision.
• the seal between the base and the pillar can be ensured by any suitable means, for example one or more O-rings or annular seals or even a continuous membrane capable of being perforated at the level of the passage or passages contained in the pillar.
• the means for fixing the removable pillar to the base preferably include one or more screws capable of passing through the pillar in order to be screwed into a complementary tapping on the base.
• this screw is hollow, so as to form a fluid passage and be able to communicate with a passage contained in the base, the screw having, at its upper end, the above-mentioned valve.
• the base can advantageously be in the form of a plate, of the osteosynthesis plate type, with holes allowing the passage of screws, clips, or other fixing means against a bone surface previously deperosted, said plate having a shaped part.
• base, the surface of which faces the pillar has at least one opening communicating with said implantable conduit, preferably by through a passage made along the plate in a thickened element of the plate, allowing both to connect the conduit substantially in the plane of the plate, that is to say in a plane substantially parallel to the skin surface.
• the implantable conduit can be brought to the level of the part of the plate intended to form the base itself, subject to providing in this part a connection means allowing connection with said conduit implantable in a position substantially parallel to the plate, that is to say substantially perpenicular to the abutment.
• the base may have no passage of fluid and the implanted conduit is then brought, parallel to the base, to connect directly to a radial mouth of the lower end of the abutment, provided that the internal end of the abutment enters the base to approach the bone surface on which the base is fixed.
• the device according to the invention is preferably made of a metallic material and, in a particularly preferred manner of titanium or titanium alloy. It is particularly well suited to be fixed on a cranial bone, preferably parietal or temporal in the vicinity of the ear.
• the device according to the invention may also include means allowing transcurrent passage of electrical conductors and / or optical fibers.
• An electric current transfer device is described, for example, in PCT / FR / 96 00141.
• Such an electric current transfer device can be contained, either in the same pillar which presents the fluid transfer duct (s), or, less preferably, in a separate pillar carried, preferably, by the same base at a certain distance from the pillar for the passage of fluid.
• the device according to the invention can be used to ensure the transfer of any fluid to or from the body.
• any fluid such as insulin, morphine derivatives, anticoagulants, chemotherapy products, etc.
• medicament such as insulin, morphine derivatives, anticoagulants, chemotherapy products, etc.
• an implanted pump connected to one end of the implantable conduit.
• the transferred fluid may however also be a gaseous fluid, in particular compressed air, for example for the operation of an artificial heart or a means of mechanical cardiac assistance.
• FIG. 1 shows a top view of a base of a device according to the invention with partial section at the fluid connection;
• FIG. 3 shows a profile section view of this device at an electrical connection
• FIG. 6 shows an axial sectional view of a fixing screw for this pillar
• - Figure 7 shows a tempo- cap base raire
• the device according to the invention consists of a base, fluid-implanted conduits, one or more pillars, seals, and hollow screws forming a fluid passage provided with '' a valve at the screw head, as well as a removable protective cap for the base during the first implantation phase.
• the base 1, shown in Figures 1 to 3, has a central barrel 2 at the base of which are fastening means 3, substantially perpendicular to the axis of the barrel and whose size and arrangement can vary depending on the anatomical requirements of the bone surface on which the device according to the invention is fixed.
• these means form a maxillofacial type plate provided, for example, with a plurality of blades 4 arranged in a network, the nodes of which have a form of coping provided with a hole 5 intended for the passage of '' a bone fixation screw.
• These holes 5 can, where appropriate, present, in a conventional manner, a spherical bearing for the seat of a spherical screw head.
• the barrel has, on its upper surface, two holes 6, the upper part, of enlarged diameter, is tapped, the lower part, blind, opening into a bore 7 made, in the plane of the fixing plate, in a transverse branch thickening 8 of the plate ending in a tip 39, to which the end of an implanted flexible conduit, such as a catheter, intended to direct towards a user device, for example a delivery pump, will be connected insulin.
• the base 1 is supplied from the factory in a sterile condition with a protective cap intended to cover the barrel 2 in a leaktight manner and hermetically prevent any passage of blood or of figured elements towards the holes 6.
• the total height of the base, including the excess thickness of the cap is preferably less than 7 mm, so as to allow easy healing of the skin above the entire plate and the barrel after implantation. Pillar 10, shown in Figures 4 and
• the base 10 has a generally cylindrical shape with an upper radial lug 11 of polarization.
• the lower half of the base 10 has a large cylindrical recess 12 and an internally chamfered end 13 for fitting onto the barrel 2 received in the recess 12 until contact with the end 13 with a corresponding bearing 14 of the barrel 2.
• the adjustment on the barrel is preferably smooth sliding.
• the upper part 14 of the pillar is full and has two holes 15 passing through the part 14 and emerging through an opening of smaller diameter 16 in the internal volume 12 of the lower part.
• the axes of the two holes 15 coincide with the axes of the two holes 6 of the barrel.
• This screw 17 has a threaded body 18 having, at its upper end, a flange 19 surrounding a conical base extending by an axial cylindrical pillar 20 whose upper end 21 flares to form a substantially frustoconical sealing surface.
• a hexagonal blind hole 22 is made than in the flared part 21 for receiving a screwing tool.
• the screw body 18 has a central bore 23 forming a longitudinal passage opening upwards through inclined bores 24 in the frustoconical base surmounting the flange 19.
• a cylindrical ring 25 On the beam of the collar 19, a cylindrical ring 25 has been welded, the upper end 26 of which, on the internal side, has a progressive flaring reducing the diameter of the cylindrical chamber formed by the part 25 and forming, under this extremi ⁇ ty, an external sealing surface.
• annular mouth thus formed between the end 26 and the flare 21, and which has two concentric sealing surfaces, can be closed by an O-ring seal 27 carried by a sliding valve 28 returned to the closed position by a return spring 29 bearing on the upper edge of the flange 19.
• a fixed seal 30 can be provided to cooperate with the shoulder in the passage 15 formed by the narrowing 16.
• the two screws are successively introduced into the two passages 15 and, using a tool using the hexagonal hole 22, the threaded screw body is screwed 18 in the thread of the hole 6 aligned in the base until the axial stop contact against the pillar.
• the part 25 is received in the recess 15 and the upper end of the screw is flush with the upper extremity of the pillar while the mouth of the end piece 9 is in communication, through the passages 7 and 6 with the passage 23, the bores 24 and the underlying chamber closed by the valve 28 with its seal.
• cap 38 which can coat the barrel 2 in a sealed manner by being fixed to it by a screw passing through an eccentric hole temporarily screwed into one of the passages 6.
• the installation of the device according to the The invention is carried out as follows:
• the surgeon implants the base 1, the barrel of which is protected by its cap 38.
• This pose is carried out in a completely conventional manner on the bone accessible through an incision in the skin plane.
• this installation is carried out at the same time as that of the implanted conduits and, where appropriate, of the implanted device to which the conduits must end, which avoids having to temporarily protect the end pieces 9, the implanted conduits being immediately connected. to the base.
• the free end of the abutment can be coated with a cap but one can also omit such a cap, the entry of germs being made impossible because the fluid, in particular the liquid, the blood or therapeutic liquid, contained in the implanted duct and the screw 23 is in overpressure relative to the atmosphere. In addition cleaning the upper face of the pillar and screws is easy.
• the end piece of an external fluid communication conduit which will preferably comprise a means allowing it mechanically lowering the valve 27, 28 to allow passage between the interior and the exterior.
• the device according to the invention may also include means for transcutaneous transfer of energy or of electrical or light information.
• a second barrel 31 has been shown in the drawing, the outer surface of which is similar to that of barrel 2.
• This barrel 31 has an annular recess 32 surrounding a central hub 33 provided with a threaded axial bore 34.
• the bottom of the annular recess 32 communicates, through a hole 35, with a passage 36 similar to the passage 7 made in a thickened part 37 of the plate.
• a channel is thus formed allowing the passage into the recess 32 of a plurality of insulated electrical conductors or implanted optical fibers.
• insulating connector element 39 housed in one recess 32 and having a plurality of housings 40 angularly spaced ( Figures 8 and 9) in which one comes to be housed, for each conduc ⁇ tor, a female contact extending parallel to the axis of the barrel 31.
• a sealing membrane covers the upper face of this insulating element.
• the barrel is intended to receive a transcutaneous pillar 41 (FIG. 10) fixed on the barrel 31 by screwing a screw in the central thread 34, this pillar having, on its underside, electrical contact elements, by example of the pins, complementary to the contact elements fixed in the base, contained in an insulating connector element 42 (FIG. 11).
• pins may, for example, be provided to perforate the sealing and insulation membrane interposed between the barrel and the pillar.
• a connector insulating element 43 (FIG. 12)
• a plurality of contacts electrically connected with the contacts situated at the base of the barrel for fixing a connector element.
• the barrel 31 is provisionally covered with a cap. A single screw, screwed into the internal thread 34, holds all the parts.
• optical fibers terminate, at the level of the recess 32, by being connected to an optical connector element of a conventional type which is housed in said recess 32 while being protected by a protective cap during implantation.
• an optical pillar having at its lower end the optical connection means allowing the light connection with the connection means of the base which terminate the individual fibers, this optical connector leading, to the upper face of the pillar, to a another optical connector capable of being connected to a complementary connector of an external device.
• the various fluidic, electrical and / or optics in a single barrel, especially in the case where provides only a single fluid conduit installed so that there is space in the barrel to install the electrical or optical connection means.
• the device contains one or more drums allocated only to an optical and / or electrical connection without the device containing connection means. fluidics.

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• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
• Hematology (AREA)
• Pulmonology (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Gastroenterology & Hepatology (AREA)
• Biophysics (AREA)
• Prostheses (AREA)

Applications Claiming Priority (3)

Publications (1)

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ID=9493348

Family Applications (1)

Country Status (6)

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• 1996
  • 1996-06-24 FR FR9607819A patent/FR2750054B1/fr not_active Expired - Fee Related
• 1997
  • 1997-06-23 JP JP10502443A patent/JP2000513252A/ja active Pending
  • 1997-06-23 AU AU34473/97A patent/AU3447397A/en not_active Abandoned
  • 1997-06-23 CA CA002261088A patent/CA2261088A1/fr not_active Abandoned
  • 1997-06-23 EP EP97930567A patent/EP0914170A1/de not_active Withdrawn
  • 1997-06-23 WO PCT/FR1997/001114 patent/WO1997049438A1/fr not_active Application Discontinuation

Non-Patent Citations (1)

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