IE52353B1 - An insertion device for catheters,probes or the like - Google Patents

An insertion device for catheters,probes or the like

Info

Publication number
IE52353B1
IE52353B1 IE2594/81A IE259481A IE52353B1 IE 52353 B1 IE52353 B1 IE 52353B1 IE 2594/81 A IE2594/81 A IE 2594/81A IE 259481 A IE259481 A IE 259481A IE 52353 B1 IE52353 B1 IE 52353B1
Authority
IE
Ireland
Prior art keywords
sealing element
housing body
sealing
insertion device
catheters
Prior art date
Application number
IE2594/81A
Other versions
IE812594L (en
Original Assignee
Intermedicat Gmbh
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
Application filed by Intermedicat Gmbh filed Critical Intermedicat Gmbh
Publication of IE812594L publication Critical patent/IE812594L/en
Publication of IE52353B1 publication Critical patent/IE52353B1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M39/0606Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof without means for adjusting the seal opening or pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/062Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
    • A61M2039/0646Duckbill-valve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0633Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
    • A61M2039/0653Perforated disc
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0686Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof comprising more than one seal

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)
  • Electrotherapy Devices (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Magnetic Resonance Imaging Apparatus (AREA)
  • Emulsifying, Dispersing, Foam-Producing Or Wetting Agents (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)

Abstract

1. An introduction device for catheters, probes or the like, comprising a housing body (2) which has a continuous longitudinal channel (5) to be connected to a cannula (24), and comprising two sealing elements (10, 16) which are positioned in tandem on the rear end of the housing body (5), are each made of elastic material and have expandable openings (11, 18) for the passage of elongate objects (25, 26), characterised in that the first sealing element (10) consists of a part which is tubular in an idle condition, the front section of which freely projects axially into the channel (5) of the housing body (2) and has at its front two sealing lips (12, 13) which press against each other, and the second sealing element (16) consists of a disc which is positioned between the rear end of the housing body and he first sealing element (10) and has an expandable opening (18) which is produced without removing any material.

Description

This invention pertains to an insertion device for catheters, probes or the like.
To insert a catheter into a blood vessel, a cannula, made of metal or a synthetic material, is first inserted into the lumen of.the blood vessel and then it is advanced through this passage to the required distance. Then the catheter is inserted through the cannula. Subsequently, the cannula is withdrawn while the catheter remains in the blood vessel. Blood can flow from the blood vessel to the outside through the gap which exists between the catheter and the inserted cannula. Therefore, suitable measures are required to keep this blood loss within limits. This is possible without great difficulty in veins where the blood pressure is relatively low. But when an artery is punctured, sealing of the gap for prevention of blood loss and contamination is considerably more difficult.
In a known catheter insertion device of Specification No. the above-mentioned type (U.S. Patent/4,000,739), two sealing elements in combination are provided in a housing. The first sealing element consists of a disk having a central Y-shaped notch through which a catheter can be inserted by spreading the sealing element apart. The second sealing element is a flat disk, having an axial hole, which supports the first sealing element. As a result of the pressure occurring in the housing body, the first sealing element is tightly pressed against the second sealing element, which is positioned behind it. In this manner a catheter passage is formed which seals the cannula end against air and fluids before the catheter is inserted, during the insertion step as well as after the catheter is inserted.
In order to be able to use the described insertion device for catheters of different sizes, various sealing disks, which are used as second sealing elements in the housing, have to be available and their hole diameters correlated to the diameter of the catheter to be used. The various sized sealing disks easily lead to errors and mix-ups, with serious consequences, when they are used. Another disadvantage of sealing disks with pre-determined hole diameters occurs during a single use of the insertion device when two elements, varying considerably in diameter, have to be slid through the sealing element while maintaining the seal. Thus, for certain purposes, in a first operating step, a spiral guide with a diameter, for example, of 0.6 mm, and in a second operating step a catheter with an outer diameter of 1.8 mm, are passed through the insertion device.
The second sealing element is unsuitable for such a large diameter range.
Even the first sealing element with its symmetrical Y-notch arranged in front of the second sealing element does not effect a seal of the required quality. For geometrical reasons, the triangular areas formed by the Y-notch, the points of which project forwardly, cannot seal the circumference of the catheter by covering it completely so that leaks occur at the points of the notch. In addition, a sealing disk which is subdivided by the slits into triangular flaps, after the flaps have been bent open, will not exactly resume its original position in which the slits were completely closed. The flaps obstruct each other during the return movement into their original or starting position. The restoring or retracting power (sometimes also called memory) of the rubber elastic material is not sufficient to overcome the obstacles.
An object of the invention has the task of providing an improved insertion device of the above-described type which will permit use and sealing of parts with varying diameters without changing the sealing elements.
According to the invention, an insertion device for catheters, is provided probes or the like/comprising a housing body for connection to a cannula, said housing body having a continuous longitudinal bore, and two sealing elements which are disposed one behind the other from a rear end of the housing body, each sealing element being made of elastic material and having expandable openings for the passage of elongate objects, wherein the first sealing element is substantially tubular at rest, a front section of said first sealing element freely projecting axially into the bore of the housing body and having at its front two sealing lips which press against each other at rest, and the second sealing element is disc-like,is positioned between the rear end of the housing body and the first sealing element, and has an expandable opening produced without removing any material. The second sealing element can be a disk-like element with a centrally positioned thin membrane -like area having a perforated opening.
When a catheter or other elongated element is inserted into the insertion device, the perforated opening, in the thin membrane-like area of the disklike second sealing element is opened first. The membrane strength and the material of the second sealing element are selected so that catheters and guide wires of varying diameter can be passed through the perforated opening with reasonable force while simultaneously the disk, because of its high flexibility, radially tightly contacts and seals the circumferential surface of the object which has been passed through it. The rim of the disk may be made thicker than the thin membrane-like central area.
The first sealing element, which directly adjoins the second sealing element, has a cylindrical hollow portion with a cone-shaped or partially coneshaped front portion which is divided by a longitudinal cut, thus forming two lips. When an object is inserted, the lips spread apart. Thereafter, if the object is pulled back the lips, due to the inherent retracting or restoring ability of the material of which the sealing element is made, join again with their cut edges and close. Any pressure in the interior of the housing body acts on the outer area of the conical portion, whereby the sealing lips are pressed even more tightly together or against the circumferential wall of an inserted object. The sealing lips move exclusively radially to the axis of the first sealing element.
The first sealing element, with the sealing lips formed on the end of a substantially conical portion, collaborates with the second sealing element disk-like elastic membrane perforated opening formed without material removal, and a seal is obtained which meets the described requirements and permits simultaneous insertion of objects of varying diameter.
The following description explains in detail an embodiment of the invention.
Figure 1 is a longitudinal sectional view of an insertion device provided by the invention; and Figure 2 is an exploded sectional view of the main parts of the insertion device shown in Figure 1.
The insertion device 1 has a substantially tubular-shaped housing body 2, the back end of which or cover is covered by a cap/3 which has, m its front section, a concentrically arranged hole/iP^xtilnding outwardly in the shape of a cone. The cap 3 can be attached by gluing, welding, or by a snap lock connection, to the housing body 2.
The housing body 2 has a longitudinal bore or channel which, by means of several step-like sections, or step-shaped widening each of which forms an annular shoulder/6, 7, 8, widens towards the back end which is covered by the cap 3' or peripheral region The protruding rim/9 of first sealing element 10 is positioned against the annular shoulder 6 of the housing body 2. First sealing element 10 is substantially tubular in shape and extends freely from the rim 9 into the bore 5 towards the front.
The front end of the first sealing element 10 is tapered conically, and the point is rounded off.
Furthermore, the front end of the sealing element 10 is subdivided by a longitudinal slit 11 into two symmetrical sealing lips 12 and 13 which can be spread or expandable opening apart. The longitudinal slit/11 extends over a considerable portion of the length of the sealing element 10, for example, over a distance in the order of magnitude of 1/3 to 1/2 of its length. The sealing element 10 acts with its sealing lips 12 and 13 as a reverse flow lock. The bore or hole 14 formed in its interior is so designed that tubular or elongated objects with the largest required diameter can be pushed through the cylindrical portion 14 of the sealing element without wall friction. The rim 9 of the sealing element 10 has a thickness such that it substantially occupies the entire space between the two ring shoulders 6 and 7.
Rim 15 of the second sealing element 16 is positioned against the annular ring shoulder 7, Second sealing element 16 is shaped like a disk with a thin membrane-like central area 17 which is surrounded by the thickly designed rim 15. In the center of the membrane-like central area 17, a perforation or opening 18, which is introduced without material removal, is provided. The membrane-like area 17 acts as a circumferentially conformable or adjustable sealing element for catheters and guiding elements of varying diameter or size.
The front side of a supporting plate 19 is positioned against the rear annular ring shoulder 8 of housing body 2. Plate 19 presses against the back side of the rim 15 of the second sealing element 16. Sealing elements 10 and 16 are thus secured in place and their rims slightly compressed. The supporting plate 19 has central hole 20 which is sized to permit ready passage of the largest diameter catheter or other element to be inserted. The hole 20 is located below the hole 4 in cap 3.
The front end of the housing body 2 has an axially projecting conical stub 21 onto which connector 22, which has a cone-shaped internal bore 23, can be sealingly slid. A cannula 24, inserted into and fastened to the connector 22, ends at the bore 23.
When the described insertion device is used, a blood vessel puncture takes place first by means of a perforating cannula (not illustrated).
The guiding wire 26 is inserted into the blood vessel through the perforating cannula and advanced to the location to be tested. Then the perforating cannula is removed. After this the dilator 25, together with the cannula 24 surrounding the same (see Figure 1) are slid over the guiding wire and into the blood vessel. Blood can leave through the gap between the cannula 24 and the dilator 25. To prevent this, sealing elements 10 and 16 are provided in housing body 2. The blood pressure applied to the interior of bore 5 presses the sealing lips 12 and 13 laterally tightly against the dilator 25 so that no blood can leave the housing body 2.
Finally, the dilator 25 together with the guide wire 26 are removed by pulling them back.
Then the sealing lips and 12 and 13, of the first sealing element 10, with their sealing areas come together and close the passage against outward flow of blood.
When the cannula 24 has been positioned in the described manner, it serves as an inserting tube through which a catheter, probe, or other device can be directed to the blood vessel. For this purpose, the catheter or similar device is inserted through the openings of the second sealing element 16 and the first sealing element 10 into the cannula 24.
The openings adjust elastically to the diameter of the catheter or other device and effect a pressuretigTit seal. Preferably, the seals are made of cross5 linked rubber, for example, one based on isoprene or a silicone. Thermoplastic elastomers are also suitable for the seals.

Claims (8)

1. An insertion device for catheters, probes or the like, comprising a housing body for connection to a cannula, said housing body having a continuous longitudinal bore, and two sealing elements which are disposed one behind the other from a rear end of the housing body, each sealing element being made of elastic material and having expandable openings for the passage of elongate objects, wherein the first sealing element is substantially tubular at rest,a front section of said first sealing element freely projecting axially into the bore of the housing body and having at its front two sealing lips which press against each other at rest, and the second sealing element is disc-like,is positioned between the rear end of the housing body and the first sealing element, and has an expandable opening produced without removing any material.
2. An insertion device according to Claim 1, wherein the first sealing element is tapered conically towards its front end.
3. An insertion device according to Claim 1 or Claim 2, wherein the first sealing element has a slit which extends over said front of the element and runs into opposite side walls of the element.
4. An insertion device according to any of Claims 1 to 3, wherein the two sealing elements are disposed one directly behind the other and contact each other in peripheral regions of the elements.
5. An insertion device according to any of Claims 1 to 4, wherein the second sealing element has a membrane-shaped central region, the thickness of which is less than that of a peripheral region of the element.
6. An insertion device according to any of Claims 1 to 5, wherein at least one step-like enlargement is provided in the rear region of the housing body to support peripheral regions of the sealing elements.
7. An insertion device according to any of the preceding claims, wherein a rear opening of the housing body is closed by a cover which has an opening and which keeps peripheral regions of the sealing elements pressed together. 523S3
8. An insertion device for catheters, probes or the like substantially as described with reference to the accompanying drawings.
IE2594/81A 1980-11-08 1981-11-05 An insertion device for catheters,probes or the like IE52353B1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE3042229A DE3042229C2 (en) 1980-11-08 1980-11-08 Insertion device for inserting elongated objects into blood vessels

Publications (2)

Publication Number Publication Date
IE812594L IE812594L (en) 1982-05-08
IE52353B1 true IE52353B1 (en) 1987-09-30

Family

ID=6116320

Family Applications (1)

Application Number Title Priority Date Filing Date
IE2594/81A IE52353B1 (en) 1980-11-08 1981-11-05 An insertion device for catheters,probes or the like

Country Status (10)

Country Link
EP (1) EP0051718B1 (en)
JP (1) JPS57110262A (en)
AT (1) ATE6593T1 (en)
DE (2) DE3042229C2 (en)
DK (1) DK384081A (en)
ES (1) ES269154Y (en)
FI (1) FI70143C (en)
IE (1) IE52353B1 (en)
NO (1) NO149338C (en)
PT (1) PT73754B (en)

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US3557778A (en) * 1968-11-18 1971-01-26 Elbert L Hughes Blood specimen collection assembly
DE7129912U (en) * 1971-08-04 1972-04-20 Schaeffer H Infusion cannula for intravenous infusions into veins near the heart with automatic protection against air intake
US3900028A (en) * 1974-02-26 1975-08-19 American Hospital Supply Corp Injection site for sterile medical liquid container
US3911927A (en) * 1974-04-17 1975-10-14 Princeton Biomedix Eversible catheter
DE2456980C3 (en) * 1974-12-03 1978-05-18 Gerhard 3400 Goettingen Guenther Insertion sleeve for catheters and endoscopes
US4000739A (en) * 1975-07-09 1977-01-04 Cordis Corporation Hemostasis cannula
US4096860A (en) * 1975-10-08 1978-06-27 Mclaughlin William F Dual flow encatheter
DE2817102C2 (en) * 1978-04-19 1985-01-24 Dr. Eduard Fresenius, Chemisch-pharmazeutische Industrie KG, 6380 Bad Homburg Connector for plastic cannulas or venous catheters

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5630799A (en) 1991-08-21 1997-05-20 Smith & Nephew Dyonics Inc. Fluid management system
US5630798A (en) 1991-08-21 1997-05-20 Smith & Nephew Dyonics Inc. Fluid management system
US5643203A (en) 1991-08-21 1997-07-01 Smith & Nephew Dyonics Inc. Fluid management system
US5840060A (en) 1991-08-21 1998-11-24 Smith & Nephew, Inc. Fluid management system
US5882339A (en) 1991-08-21 1999-03-16 Smith & Nephew, Inc. Fluid management system

Also Published As

Publication number Publication date
DK384081A (en) 1982-05-09
PT73754B (en) 1982-11-11
FI70143C (en) 1986-09-15
NO149338B (en) 1983-12-27
ES269154U (en) 1983-06-16
DE3162672D1 (en) 1984-04-19
ATE6593T1 (en) 1984-03-15
EP0051718B1 (en) 1984-03-14
DE3042229C2 (en) 1983-10-27
FI70143B (en) 1986-02-28
EP0051718A1 (en) 1982-05-19
PT73754A (en) 1981-10-01
DE3042229A1 (en) 1982-05-19
NO813207L (en) 1982-05-10
IE812594L (en) 1982-05-08
NO149338C (en) 1984-04-11
ES269154Y (en) 1984-01-01
FI812962L (en) 1982-05-09
JPS57110262A (en) 1982-07-09

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