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
  • A61M39/0208—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
  • A61M39/04—Access sites having pierceable self-sealing members
  • A61M39/045—Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument
• • 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
  • A61M2039/022—Subcutaneous access sites for injecting or removing fluids being accessible from all sides, e.g. due to a cylindrically-shaped septum
• • 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
  • A61M2039/0226—Subcutaneous access sites for injecting or removing fluids having means for protecting the interior of the access site from damage due to the insertion of a needle

Definitions

• the present invention relates to the general technical field of devices intended to be surgically introduced under the skin of a human or animal patient, so that it can subsequently be stitched by means of a hollow needle, through the skin of the patient, to introduce and / or remove substances in the body of the patient, by limiting repeated skin injuries in the same place.
• Such devices are generally called implantable sites, or access ports.
• the present invention more particularly relates to an implantable device for injecting and / or removing fluid either from an organ or vessel of the body of a human or animal patient, or from an inflatable and / or deflatable compartment of a surgical implant, said device comprising a housing within which is provided a chamber for connection to a catheter, said catheter being itself intended to be connected to said organ or vessel or to said compartment, the housing having a proximal wall and a distal wall between which extends a side wall, said housing comprising a puncture area designed to be pierced by a hollow needle for injecting and / or withdrawing fluid from the chamber.
• Implantable sites are generally in the form of a housing having a bottom from which extend lateral walls whose free ends define a proximal opening.
• the bottom and the side walls are made of a solid and rigid material, such as titanium, to prevent they can be pierced by a needle.
• the proximal opening is closed by a substantially planar membrane of self-sealing material, thus forming a "septum".
• Such devices if they generally give satisfaction, nevertheless have significant disadvantages.
• the objects assigned to the invention therefore aim at proposing a new implantable injection and / or fluid sampling device making it possible to remedy the various disadvantages listed above and facilitating implantation operations as well as injeotion and / or sampling.
• Another object of the invention is to propose a new implantable injection and / or fluid sampling device that allows the practitioner to prick according to a gesture substantially similar to that used when pricking a natural vein.
• Another object of the invention is to propose a novel implantable injection and / or fluid sampling device which reduces the risks and drawbacks associated with body movements performed by the patient.
• Another object of the invention is to propose a novel implantable injection and / or fluid sampling device which does not need to be sutured to the body of the patient.
• Another object of the invention is to propose a new implantable injection and / or fluid sampling device of particularly simple and compact design.
• Another object of the invention is to propose a new implantable device for injecting and / or removing particularly light fluid.
• Another object of the invention is to provide a new implantable device for injection and / or fluid sampling particularly safe.
• the objects assigned to the invention are achieved by means of an implantable injection and / or fluid sampling device either in an organ or vessel of the body of a human or animal patient, or in an inflatable compartment and or deflating a surgical implant, said device comprising a housing in which is formed a chamber intended to be connected to a catheter, said catheter being itself intended to be connected to said body or vessel or to said compartment, the housing having a proximal wall and a distal wall between which a side wall extends, said housing comprising a puncture area designed to be pierced by a hollow needle for injecting and / or withdrawing fluid from the chamber characterized in that said puncture zone is shaped to extend both at least on the proximal wall and the side wall.
• FIG. 1 illustrates, in a schematic perspective view, a first embodiment of a device according to the invention.
• FIG. 2 illustrates, in a schematic perspective view, a second embodiment of a device according to the invention.
• FIG. 3 illustrates, in a schematic perspective view, a third embodiment of a device according to the invention.
• FIG. 4 illustrates, in a schematic perspective view, a fourth embodiment of a device according to the invention.
• - Figure 5 illustrates, in a schematic perspective view, a fifth embodiment of a device according to the invention.
• FIG. 6 illustrates, in a schematic longitudinal sectional view, a sixth embodiment of a device according to the invention.
• FIG. 7 illustrates, in a schematic longitudinal sectional view, a seventh embodiment of a device according to the invention.
• FIG. 8 illustrates, in a schematic cross-sectional view, a device according to one or the other of the sixth and seventh embodiments respectively illustrated in Figures 6 and 7.
• FIG. 9 illustrates, in a schematic cross-sectional view, an eighth embodiment of a device according to the invention.
• FIG. 10 illustrates, in a schematic perspective view, the internal structure of the device shown in Figure 2.
• FIG. 11 illustrates, in a schematic side view, a ninth embodiment of a device according to the invention, forming an artificial vein.
• Figure 12 illustrates, in a schematic cross-sectional view, the device shown in Figure 11.
• the invention relates to an implantable device 1 for injection and / or fluid sampling.
• a device which could also be referred to as an "implantable site"
• implantable site is intended to be implanted surgically in the body of a patient, and in particular under the skin of said patient, to constitute an access port for the introduction or extraction of fluids within the body of said patient, which may be human or animal.
• the implantable device 1 according to the invention can be implemented and adapted for different uses.
• the implantable device 1 according to the invention may be designed for the injection and / or the removal of fluid from an organ or vessel of the body of a patient, and in particular into the venous and / or arterial system. said patient.
• the device 1 according to the invention allows the injection of drugs into a vein or artery.
• the device 1 according to the invention may also be adapted to supply implanted reservoirs of the insulin pump or analgesic type.
• the device 1 according to the invention is adapted to form an artificial vein (or artery), which the practitioner, doctor or nurse, can sting to the way of a natural vein to inject a drug substance or take blood.
• the implantable device 1 may also be adapted for injecting and / or withdrawing fluid into an inflatable and / or deflatable compartment of a surgical implant, and in particular a gastroplasty ring intended for treatment. of obesity.
• a gastric band is known per se, and is generally formed by a flexible band intended to be closed in a loop around the stomach substantially towards and by its two ends, with the aid of a closure system, to reduce the diameter of the opening of the stoma.
• Said strip may comprise an annular compression chamber with adjustable volume, connected by a catheter to an implantable device 1 according to the invention, which allows the internal pressure of the chamber to be adjusted in order to adjust the diametrical expansion of the latter.
• the device which is the subject of the present invention may, however, be used for the adjustment of other surgical implants, such as, for example, balloons or artificial sphincters.
• hypodermic device that is to say intended to be positioned just under the skin of the patient.
• the device according to the invention may, however, be implanted at other locations in the body of the patient, and in a deeper way.
• the device 1 comprises a housing 2 in which is formed a substantially sealed and sealed chamber 2A.
• Said chamber 2A is intended to be connected to a catheter 3, said catheter 3 being itself intended to be connected to either the organ or vessel 10 to which it is desired to inject or withdraw fluid (see FIG. inflatable / deflatable compartment of the surgical implant (not shown).
• the casing 2 comprises a proximal wall 4 and a distal wall 5, between which a side wall 6 extends.
• proximal is meant in a conventional manner the wall situated immediately under the skin of the patient, once the device 1 implanted subcutaneously.
• the housing 2 comprises, in a conventional manner, a puncture zone 7 designed to be pierced by a hollow needle 14, for injecting and / or withdrawing fluid from the chamber 2A.
• the puncture zone 7 comprises a self-sealing membrane, made for example of elastomeric material, of the silicone type.
• a membrane has "self-healing" properties. Thanks to these properties, the orifice generated by the piercing of the membrane with the help of the needle 14 is automatically re-opened after extraction of the needle 14, which makes it possible to substantially maintain the tightness of the chamber 2A.
• the puncture zone 7 is shaped so as to extend both at least on the proximal wall 4 and the side wall 6.
• the invention proposes a radically opposed concept, which consists of extending the puncture zone 7 to the side wall 6, so as to render unnecessary, or at least not essential, fixation of the device ⁇ by suture.
• the device 1 in case of tilting, for example under the effect of the movements of the patient, the device 1 according to the invention, the probability that the puncture zone 7 is no longer accessible is reduced, since said puncture area 7 extends not only at the level of the proximal wall 4 but also at the level of the side wall 6.
• the proximal walls 4, distal 5 and side 6 together contribute to form a substantially polyhedral surface.
• the proximal 4, distal 5 and lateral 6 walls form a rectangular parallelepiped.
• the side wall 6 is formed on the one hand of two parallel longitudinal panels 6A, 6B and on the other hand of two parallel transverse panels 6C, 6D, said transverse panels 6C, 6D extending in a substantially perpendicular direction to the direction in which the longitudinal panels 6A, 6B extend.
• the catheter 3 is intended to be connected to the chamber 2A at one of the transverse panels 6C, 6D, via a conduit 3A connecting the chamber 2A to the outside of the device 1 and extending longitudinally substantially in the direction of the longitudinal panels 6A, 6B.
• the puncture zone 7 extends over most or even substantially all of the proximal walls 4, distal 5 and longitudinal panels 6A, 6B.
• the transverse panels 6C, 6D will obviously also constitute the puncture zone 7, although this is not really necessary, given the low risk of tilting of the device 1 around the transverse direction.
• all the faces of the housing 2 shown in FIG. 1 can advantageously be used for the puncture, so that an accidental reversal of the site 1 would not entail any truly embarrassing consequences for the practitioner or the patient.
• the duct 3A which connects the chamber 2A to the outside of the device 1 and which is intended to be connected to the catheter 3, extends longitudinally along a first axis X- X '.
• the conduit 3A may be provided with a coaxial bulge 30A (see FIGS. 6 and 7) with a diameter slightly greater than the nominal internal diameter of the catheter 3.
• the catheter 3, which conventionally has a certain radial elasticity, is thus threaded into force on the conduit 3A and the bulge 30A, which ensures its maintenance.
• the catheter 3 is surrounded, in the vicinity of the conduit 3A, a stiffening means 20 (see Figures 1 to 5), consisting for example of a tube or a helical wire 21, the kind spring.
• the stiffening means 20 which may moreover have a certain flexibility in bending, makes it possible to avoid the accidental closing phenomena of the catheter 3 by folding the latter.
• the proximal walls 4, distal 5 and lateral walls 6 are shaped and arranged so that the housing 2 has substantially a symmetry with respect to a second axis Y-Y ', said second axis YY' being substantially parallel to the first axis X-X '.
• the housing 2 thus has a symmetry of revolution about a second axis YY ', which extends substantially in the same direction as the conduit 3A for connecting the catheter 3.
• a second axis YY ' which extends substantially in the same direction as the conduit 3A for connecting the catheter 3.
• the proximal 4, distal 5 and lateral 6 walls together form a substantially spherical surface, as shown in FIG. 3.
• the puncture zone 7 may extend substantially over the all of the proximal walls 4, distal 5 and lateral 6, that is to say on substantially the entire spherical surface.
• the puncture zone 7 extends only over a central circular band of the spherical surface, said circular band being symmetrical relative to the second axis YY ', which is preferably coincident with the first axis X-X '.
• the proximal walls 4, distal 5 and lateral 6 together contribute to form a substantially ovoidal surface, extending longitudinally along the axis YY ', in the same direction that the duct 3A.
• Such an ovoid housing is particularly easy to introduce under the skin of the patient, and particularly well tolerated by the latter.
• the puncture zone 7 of the ovoid casing of FIG. 2 can extend substantially over all the proximal walls 4, distal 5 and lateral walls 6, c '. that is to say on the whole of the ovoid surface. But it can also, and this configuration will be preferred, occupy only a central circular band of the ovoid surface, said circular band being symmetrical relative to the second axis YY '.
• the proximal, distal and lateral walls 6 together form a substantially pear-shaped surface.
• the conduit 3A for connection to the catheter 3 will be connected to the chamber 2A at the apex of the piriform surface.
• the puncture zone 7 may extend substantially over all of the proximal walls 4, distal 5 and lateral 6, or simply occupy a portion of the piriform surface, and for example, as described for the previous variants, occupy a central circular band of axis of symmetry Y-Y '.
• the proximal walls 4, distal 5 and side 6 contribute together to form a substantially cylindrical surface.
• the puncture zone 7 may extend over substantially all of this cylindrical surface, or only a portion of said surface, in particular a central circular band.
• the housing 2 corresponding to the embodiment illustrated in Figure 6 comprises a front ring 15 and a rear ring 16, positioned opposite and at a distance from one another, coaxially with the first and second axes X-X ' , Y-Y '. Between the rings 15, 16 is positioned a cylindrical sleeve 17, made of elastomeric material and which forms the puncture zone 7.
• the conduit 3A is threaded into the front ring 15, centrally relative to the axis YY '.
• the front and rear rings 15, 16 may optionally be mechanically connected by spacers (not shown), which would constrain longitudinally in compression the sleeve 17.
• spacers not shown
• the sleeve 17 would then be introduced in force between the two rings, which would create a compression of the elastomeric material along the axis YY ', which is confused in this case with the axis X-X'.
• the casing 2 comprises only one distinct ring, namely the front ring 15, the rear ring being made of material with the sleeve 17.
• the region of the sleeve 17 corresponding to the rear ring 16 is made of an elastomer material different from that in which the rest of the sleeve is made, and having for example a higher hardness.
• the casing 2 according to the invention may be formed of a frame 12 made of a material that is substantially non-pierceable by a needle 14.
• the armature 12 is advantageously covered with an envelope (not shown) made of a self-sealing material, said armature 12 being perforated to form, in cooperation with said envelope, the puncture zone 7. More particularly, the armature 12 is designed to give the casing 2 its general shape, in this case an ovoid shape for the example illustrated in FIG. 10. This armature 12 serves to support an envelope in the form of a substantially elastic pocket, for can be threaded on the frame 12 and marry the general shape of the latter, in the manner of a sock.
• the envelope may advantageously comprise a membrane made of elastomeric material, of the biomedical silicone type.
• the armature 12 is perforated, that is to say pierced, at least locally, a series of orifices of sufficient size to allow the needle 14 to pass through. The latter, after having first pierced the envelope, can thus reach the internal volume delimited by the armature 12 and corresponding to the chamber 2A.
• the armature 12 is formed of a lattice of rigid material, as shown in FIG. 10.
• This lattice may, for example, be made using titanium wires or result from the molding of a plastic material.
• housings 2 having a symmetry of revolution about the second axis YY ', itself parallel or coincident with the first axis X-X'.
• the housing 2 has no true symmetry of revolution but is simply formed of a curved or left surface, for example of elliptical section, such as that is shown in Figure 9.
• a screen 13, made of a material not pierced by the needle 14, is disposed within the chamber 2A, to avoid drilling from one side of the housing by the needle 14.
• the screen 13 thus serves as a stop for the needle 14.
• the screen 13 will in particular be designed according to the conformation of the puncture zone 7, so as to allow effective and safe stitching at any point in this zone. puncture 7.
• the screen 13 thus comprises a finned wheel shaped and positioned such that the fins 13A, 13B, 13C, 13D extend substantially radially about the axis of symmetry YY 'of the housing 2.
• the fins are at least four in number, regularly spaced angularly. It is of course conceivable to provide a lower or higher number of fins, or another type of screen 13.
• the screen 13 is further shaped to allow communication and fluid circulation within the chamber 2A.
• the four compartments delimited, within the chamber 2A, by said fins 13A, 13B, 13C, 13D do not will not be waterproof and will all be in fluid communication, even indirect, with each other.
• the screen 13 may float freely within the chamber 2A or possibly be held in position by means of an ad hoc fixing system.
• Said fixing system may for example comprise centering shafts 13E, 13F (see FIG. 6) cooperating with complementary housings formed within the housing, so as to hold the finned wheel in position, while possibly allowing it to rotate around the Y-Y 'axis.
• FIGS. 11 and 12 will now be described in greater detail, and which concerns a hypodermic device 1 for injecting a drug into a vein 11 (or artery) and / or collecting blood in said vein 11 (or artery), said device 1 thus forming a vein or artificial artery.
• the device 1 aims to faithfully mimic a natural vein, in order to substitute it for intravenous injection of medical products or blood collection operations.
• the device 1 substantially reproduces the geometry of a portion of natural vein, that is to say that it is in the form of an elongated tubular housing, made for example integrally of a pierceable material, like silicone.
• the device 1 thus constituted is intended to be flush with the skin of the patient, above the vein 11 to which it is connected.
• the device 1 according to this embodiment is intended to be stitched in the manner of a natural vein, that is to say at a grazing angle relative to the skin of the patient, and not perpendicularly, as in the case of stitching of a site of the prior art.
• Such a "tangential" stitching does not fundamentally necessitate the presence of a screen 13.
• the distal wall 5 is substantially planar and is delimited laterally by two lateral edges 5A, 5B, while the proximal wall 4 and the side wall 6 contribute to forming together a surface of revolution, for example hemi-circular, connecting said lateral edges 5A, 5B.
• the screen 13 is in turn consists of a gutter, made of a material not pierced by the needle 14, but preferably having a flexible character.
• Said gutter advantageously has a cross-section in "U”, the soul of the "U”, resting in the chamber 2A on the distal wall 5, while the arms of the "U” rise against the side wall 6.
• the housing 2 may advantageously have a radio-opaque character, by the inclusion, in its internal structure, in a uniform manner or not, of a suitable marking substance.
• the invention finds its industrial application in the production and use of implantable sites for injection and / or fluid sampling.

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• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Pulmonology (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Media Introduction/Drainage Providing Device (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Prostheses (AREA)

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• 2004
  • 2004-08-19 BR BRPI0419150-1A patent/BRPI0419150A/pt not_active Application Discontinuation
  • 2004-08-19 AU AU2004323123A patent/AU2004323123A1/en not_active Abandoned
  • 2004-08-19 WO PCT/FR2004/002161 patent/WO2006027425A1/fr active Application Filing
  • 2004-08-19 MX MX2007001991A patent/MX2007001991A/es unknown
  • 2004-08-19 CN CNA2004800438491A patent/CN101014382A/zh active Pending
  • 2004-08-19 US US11/573,929 patent/US8088112B2/en not_active Expired - Fee Related
  • 2004-08-19 EP EP04786327A patent/EP1796780A1/fr not_active Withdrawn
  • 2004-08-19 CA CA002577614A patent/CA2577614A1/en not_active Abandoned
• 2005
  • 2005-08-18 US US11/573,930 patent/US20080039772A1/en not_active Abandoned
  • 2005-08-18 WO PCT/FR2005/002104 patent/WO2006021695A1/fr active Application Filing
  • 2005-08-18 EP EP05798603A patent/EP1804898A1/fr not_active Withdrawn

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