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
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
• • 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
  • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
  • A61M2039/0258—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for vascular access, e.g. blood stream access
• • 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
  • A61M2039/027—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body having a particular valve, seal or 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
  • A61M39/0247—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 an injection ingress in ⁇ tended for substantially permanent transplant or at least long-term implanting into the body tissue of a patient, said injection ingress comprising a means protruding into the body tissue or a blood vessel and being provided with a channel for supplying an injection agent to the body tissue.
• this method of injection using conventional syringe has the advantage that the quantity of agent to be injected can be accurately measured.
• the object of the present invention is to achieve an injec ⁇ tion ingress of the type described in the introduction, which is designed to completely eliminate the drawbacks of conventional hypodermic syringes or needles without jeopar- . dizing precision in measuring' he quantity of agent to be injected.
• the object of the invention is thus to effect an injection ingress, the use of which does not inflict pain or other discomfort and which is designed in such a manner that the patient himself can perform the injection, even if his hand is shaky or he has impaired vision, or is even blind.
• the basic aim of the invention is achieved by an injection ingress wherein the supply means is provided at one end with an enlarged portion having a reception space in commu- nication with the channel, said space being designed to take the point of a hypodermic syringe, wherein the enlarged portion is provided with a positioning means to secure the arrangement to the patient's skin, and wherein the enlarged portion is provided with a valve member through which the point of the syringe can be inserted into the reception space.
• the supply member is in the form of a thin, flexible tube of material compatible with the body tissue, the enlarged portion being designed to be located mostly below the surface of the skin and consisting of or provided with a surface layer or a surface treatment to facilitate its growth into the skin.
• the object of the invention is preferably also characterised in that the tube and the enlarged portion are composed of the same material and the side wall of the tube is perfora- ted.
• Figure 1 shows a section through a portion of tissue on a patient, with a first embodiment of the invention applied
• FIG. 2 shows a modified embodiment of the invention in a view corresponding to Figure 1
• Figure 3 shows a longitudinal cross section through the object of the invention in a first, preferred embodiment
• Figure 4 shows a second embodiment of the invention in a view corresponding to Figure 3
• Figure 5 shows a third embodiment of the invention in a view corresponding to Figure 3.
• Figure 1 shows a section through the body tissue 2 and skin 1 of a patient.
• a first embodiment of the invention is implantated in an outer part of the body tissue. It can be seen that the invention comprises a supply means or tube 3, embedded in the body tissue 2 of the patient and having a suitable length, often 1 - 2 cm, for the purpose. This tube may, of course, terminate in a blood vessel instead.
• the supply means or the tube may be perforated along the side wall. This is indicated in Figure 1 by small dots.
• the free end 4 may be made narrower or be entirely closed to the longitudinal inner channel through which the medicament is supplied.
• Figure 1 also shows that the supply means 3 is provided at the end towards the -skin 2 with an enlarged portion 5, the purpose and construction of which will be described in more detail in the following.
• the enlarged portion 5 is prefer ⁇ ably provided with a collar 6 or shoulder against which rests a disc 7 of a flexibly, or possible hard material.
• An attachment part 8 is provided on the outside of the disc 7, continuing from the enlarged portion 5. This part prevents the disc from becoming detached from the enlarged portion and, as will be described below, also has certain functions with respect to the valve member which is located internally in the enlarged portion, in connection with the attachment part.
• a valve member is arranged in connection with the attachment part 8 and is so designed as to allow the point of a conventional hypodermic syringe to pass through it, thus allowing the point of this needle to enter a reception space in the interior of the enlarged portion 5.
• a narrow channel then leads from this reception space out to the supply means and the tube.
• valve member at the attachment member 8 is removed, thus forming an axially directed aperture through the entire device, into which a needle is inserted, the point extend- ing past the free end 4 of the tube 3.
• a hole is .pricked in the patient's skin and in the tissue 2 below, after which the device is pressed into the hole so that the disc 7 rests on the skin 1.
• the disc 7 is then secured with sticking plaster, adhesive or in some other suitable manner.
• the needle is withdrawn to expose the channel running axial ⁇ ly through the device and the valve member and attachment part 8 are then applied.
• the second method entails enclosing the device in a hard casing of material which will be dissolved by the body and • thus disappear.
• the casing is tubular in shape, to take the tube 3, and has a sharp point at the end.
• the procedure for securing the disc 7 is the same as that described above but in this case the valve member need not subsequently be fitted.
• Figure 3 shows a longitudinal section through the embodiment of the invention described in Figure 1. It can be seen that the enlarged portion 5 has an axially drilled bore 9 which also constitutes the reception space. A longitudinal channel 10 leads from the lower end of this bore 9 to the open end of the tube 3. It can also be seen that the enlarged portion is provided with shoulders 6 in contact with the disc 7, which in turn is held in position by the attachment part 8.
• the attachment part is in the form of a threaded nut, preferably made of metal or plastic.
• an insert 11 is used in the enlarged portion 5.
• This insert is suitably made of en ⁇ tirely rigid material such as hard plastic, metal or the like, and must be selected ensuring that it will not be affected either by the medicament to be injected through the device or by body tissue or liquid produced thereby.
• the insert 11 is entirely enclosed in the enlarged portion 5 except for an annular neck 12 with external threading to correspond with the threading on the attachment part or nut 8.
• the disc 7 has an opening into which is fitted a part 14 surrounding the in ⁇ sert 11, this surrounding part having a radially external defining wall which cooperates with the opening, correspond- ing in shape, in the disc 7.
• the disc is thus prevented from rotating in relation* to the enlarged portion 5.
• the sur ⁇ rounding part " 14 is of- course composed of the same material, inert with respect to the body, as the tube 3 and enlarged portion 5.
• the surface of the surrounding part 14 which co- operates with the disc 7 may be rectangular or polygon in order to achieve reliable engagement with the disc 7, pre ⁇ venting rotation thereof.
• valve member con ⁇ sists of a disc 15 of resilient material which is com- pressed by the nut 8 in a recess 16 in the insert 11.
• the disc 15 is compressed and made of a resilient material to facilitate penetration by the point of an injection needle without any permanent opening remaining in the disc when the needle has been withdrawn.
• the valve member will there- fore be completely self-sealing and form a perfect seal as long as it has not been penetrated too often.
• the disc 15 can be replaced by simply unscrewing the nut 8, removing the disc from the recess 16 in the insert 11 and replacing it by a new one. The attachment member or nut 8 is then screwed back into place.
• Figure 3 also shows that all surfaces of the device designed to be implanted in the skin or in the tissue below the skin of the patient consist of the same material as the tube 3 and enlarged portion 5.
• the small part 12 of the insert 11, to which the nut 8 is screwed is located outside the disc 7 and is therefore without significance insofar as contact with the body is concerned.
• Figure 2 shows a modified embodiment of the invention accord ing to Figure 1.
• the most significant difference here is tha the longitudinal direction of the supply means or tube 3 and the enlarged portion 5 is located at an angle to the plane of the disc 7.
• An internal, longitudinal channel through the device according to the invention is thus also used in this embodiment, as well as a self-sealing valve in conjunction with the attachment member 8.
• the enlarged por- tion 5 with the reception space 9 is located partially out ⁇ side the skin 1. It is of course possible to go one step further and locate this entirely outside the skin if de ⁇ sired.
• an insert 17 of substantially solid material is used, such as hard plastic or metal.
• the insert 17 fits into a corresponding recess 18 in a tubular section 19 of the end of the enlarged portion 5 opposite to the tube 3.
• a peripheral groove with conical sur ⁇ face 21 Between the tubular section 19 and the shoulder 6 for abutment against the disc 7 is a peripheral groove with conical sur ⁇ face 21, the groove expanding in axial direction away from the disc 7.
• the insert 17 is also provided with a corres ⁇ ponding conical surface 22, approximately parallel to the conical surface 21 of the groove 20.
• the insert 17 is provided with a shallow recess to hold the actual valve member or disc 15, this also consisting of resilient material under pressure.
• the pressure loading is effected in this embodiment by a ring 23, slotted in axial direction, made of a permanently deformable material such as metal and having an inwardly directed portion 24 at the end facing the disc 7, the portion 24 being approximately complementary to the groove 20.
• the inwardly directed por- tion 24 of the ring 23 will abut against the disc 7, secur ⁇ ing this in position against the shoulder 6.
• the end of the en ⁇ larged portion 5 facing away from the disc 7 is provided with a recess surrounded by a curved wall 25 and having substantially conical bottom 26.
• a ring 27 is arranged radially outside the curved wall 25 to prevent radial expan ⁇ sion and deformation of the curved wall.
• This ring prefer ⁇ ably consists of hard plastic or metal and is provided externally with a peripheral groove for a locking ring 28 to lock the disc 7 in- relation to the ring 27.
• valve member comprises a substantial ⁇ ly circular disc 15 which is pressed down into the space defined by the curved wall 25 and the conical bottom 26 of the recess in the end of the enlarged portion 5 facing away from the tube 3.
• This disc 15 is inserted through an opening 29 extending through both the ring 27 and the curved wall 25.
• the dimensions are selected so that during compression the disc 15 must be pressed to the position shown in the drawing where it is retained in compressed state, bulging slightly towards the conical bottom surface 26 and reception space 9.
• the enlarged portion 5 will not be completely rigid, but deformable, so that it too can adjust to movements in the skin and tissue below the skin.
• the material for the disc 7 should of course be substantially rigid and stable in shape. However, it should not be so hard as to cause discomfort to the user. Naturally the disc mate ⁇ rial should be of a quality which will not cause allergy or skin irritation.
• the tube 3 has been shown in all the drawings as relatively short and approximately uniform in thickness. Obviously, the tube 3 may be considerably longer and its cross section may vary, it being thicker close to the enlarged portion 5 than at the free end 4, for instance.
• a tube of this design may be suitable for supplying drugs to internal organs or the like.
• the side wall of the tube 3 may suitably be perforated, thus increasing the absorption area for the drug injected.
• an unperforated tube may also be used, and is necessary if a drug is to be accurately supplied to a specific area.
• both the tube and the enlarged portion 5 may be made of a silicon rubber, in which case they can be manufactured in one piece by an injection moulding pro ⁇ cess or by joining the enlarged portion 5 to an extruded tube, the join being effected by glueing or vulcanization. It might also be possible to make the enlarged portion of different material, such as metals like titanium or certain stainless steel alloys, for instance, the tube 3 then being glued into the enlarged portion. In this case it may be advisable to make the tube 3 thicker at the joint with the enlarged portion to prevent damage in this area. Certain grades of polythene may also be used as an alterna ⁇ tive to the above-mentioned silicon material for the tube 3 and enlarged portion 5.

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• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
• Biomedical Technology (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Hematology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Gastroenterology & Hepatology (AREA)
• Pulmonology (AREA)
• Biophysics (AREA)
• Vascular Medicine (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

Priority Applications (3)

Applications Claiming Priority (2)

Publications (1)

Family

ID=20361102

Family Applications (1)

Country Status (7)

Cited By (9)

Families Citing this family (1)

Citations (4)

• 1985
  • 1985-08-15 SE SE8503817A patent/SE453638B/sv not_active IP Right Cessation
• 1986
  • 1986-08-15 EP EP86905459A patent/EP0268590A1/en not_active Ceased
  • 1986-08-15 JP JP61504588A patent/JPS63501405A/ja active Pending
  • 1986-08-15 WO PCT/SE1986/000370 patent/WO1987001041A1/en not_active Application Discontinuation
  • 1986-08-15 AU AU62275/86A patent/AU6227586A/en not_active Abandoned
• 1987
  • 1987-04-14 DK DK192787A patent/DK192787D0/da not_active Application Discontinuation
  • 1987-04-15 KR KR870700322A patent/KR870700367A/ko not_active Application Discontinuation

Patent Citations (4)

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