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
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/06—Body-piercing guide needles or the like
  • A61M25/0662—Guide tubes
• • 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
  • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• • 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
  • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
  • A61M29/02—Dilators made of swellable material
• • 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
  • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
  • A61M39/0606—Haemostasis 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
• • G—PHYSICS
  • G06—COMPUTING; CALCULATING OR COUNTING
  • G06F—ELECTRIC DIGITAL DATA PROCESSING
  • G06F21/00—Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
  • G06F21/50—Monitoring users, programs or devices to maintain the integrity of platforms, e.g. of processors, firmware or operating systems
  • G06F21/57—Certifying or maintaining trusted computer platforms, e.g. secure boots or power-downs, version controls, system software checks, secure updates or assessing vulnerabilities
  • G06F21/572—Secure firmware programming, e.g. of basic input output system [BIOS]
• • 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
  • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
  • A61M2039/062—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with a catheter
• • 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
  • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
  • A61M2039/0633—Haemostasis 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
• • 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
  • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
  • A61M2039/0633—Haemostasis 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
  • A61M2039/064—Slit-valve

Definitions

• the invention relates to an introducer catheter comprising a valve body with a closable valve opening for introducing a medical device in the insertion direction in particular a blood vessel.
• the invention also relates to an associated valve and introducer catheter dilator assembly.
• catheters in blood vessels has been known for many years for a variety of applications.
• stents are released into blood vessels by means of inserted catheters or long-term implants are implanted. Further will be Dialysis catheter implanted.
• the catheters are also used to introduce or remove fluids from various vascular regions in the body. The introduction of
• catheterization is the enlargement of the puncture hole in the blood vessel, which is to be catheterized, while keeping the blood loss and burden on the patient as low as possible.
• Seldinger method This procedure involves the surgical opening of a vein or artery with a
• a needle introducing a guidewire through the lumen of the needle into the vein or artery, retracting the needle, inserting a dilator-introducer catheter assembly along the guidewire, removing the dilator, and inserting the actual catheter through the needle
• the introducer catheter is regularly removed by pulling it apart and removing it like a zipper.
• the delivery catheters are regular
• Hemostatic valve with a closable, regularly slit-shaped, valve opening.
• each valve is designed for use with a particular catheter size.
• valves are regularly cylindrical with parallel upper and lower sides, wherein the valve opening extending as a curve or as a slot from the top to the bottom
• valves in particular their upper and lower sides, wave and no longer seal the valve opening reliably. Accordingly, it is an object of the invention to provide a delivery catheter, which is more flexible.
• valve opening in the insertion direction in not imported medical
• Rejuvenated device and directly adjoins the rejuvenation of a sealing section.
• Substantially fluid-tight means that no fluid escapes from the blood vessel or at least no fluid flow flows out of the blood vessel.
• a medical device can be introduced into the blood vessel with comparatively low friction through the valve opening. Due to the reduced friction and the tendency to unwanted wrinkles of the
• Valve body reduced. This contributes to the fact that Valve body an imported medical device
• Valve body inserted in a blood vessel medical
• the bias can on the one hand via a
• valve body is attached to the catheter, on the valve body - and with imported medical device on this - exercised.
• the valve body is shaped such that it exerts an intrinsic bias on the sealing portion, so that a fluid-tight
• the medical device is inserted into the blood vessel.
• the bias can be applied along the entire circumference of the sealing portion or along only part of the circumference.
• the valve opening may be formed in particular slit-like manner in the region of the sealing portion.
• the extent of the slot can also approach the value 0, so that the valve opening in the region of the sealing portion as in
• Substantial punctiform breakthrough may be formed. Overall, by providing a taper in the valve opening and the bias on the sealing portion medical devices, in particular catheters,
• Valve body are introduced into blood vessels. Nevertheless, it can be ensured even with imported medical device that a blood loss from a blood vessel is completely or substantially completely prevented.
• the sealing portion is in the insertion direction in the central region, in particular in the middle, the
• valve opening adjoins in the insertion direction of the sealing portion, when not introduced
• the extension can have the same geometry as the
• the taper can be mirror-symmetrical to a direction along the direction of insertion through the valve opening
• the mirror plane may extend along the slot. In this way, in particular also advantageously a uniform bias for sealing the slot can be applied to the sealing portion.
• valve opening mirror symmetry to a transverse to
• Extend sealing section starting in the insertion direction arcuate or wave-like or linear.
• the arcuate taper and / or extension may be convex or concave.
• a wave-like taper and / or extension may include convex and concave portions.
• valve body section surrounding the valve opening is elliptical and the valve opening is slot-shaped in the region of the sealing section transversely to the insertion direction along the major axis of the elliptical valve body section extends. It is conceivable that the bias to the sealing portion only transverse to the major axis
• the bias acts on the entire circumference of the sealing portion.
• Extension has two first sections, the
• Valve opening extending mirror plane and that the taper has two second sections, which run in a semi-conical manner on the corners of the slot-shaped valve opening.
• This geometry has been found to be particularly advantageous in terms of sealing with inserted medical device and friction during insertion thereof.
• the valve body has a
• valve body for arranging the valve on a catheter.
• valve body may be attached to the catheter, wherein the formation of a connector of the
• Flange portion at least one mandrel or a recess and the catheter may have at least one corresponding recess or a mandrel.
• valve body made of silicone, in particular 8-25 Shore A, exist or comprise this material.
• This Polymer material has been found to be particularly suitable in terms of elasticity, wear and friction when inserting a medical device.
• a coating may be provided at least in the region of the sealing section.
• This coating may consist of silicone oil or comprise silicone oil.
• coatings are also conceivable that have no silicone oil.
• the outside of the valve body has at least one valve groove for forming a predetermined breaking point.
• the outside of the valve body may have at least one catheter groove lying in the same plane as the valve groove for forming a predetermined breaking point, wherein the
• Catheter groove is made together with the catheter by means of extrusion or injection molding. Consequently, the catheter groove does not have to be introduced separately in a further production step. This allows a simple way
• valve body for a catheter therefore comprises a closable valve opening, wherein the valve opening tapers in the insertion direction when the medical device is not inserted and adjoins the taper a sealing section connects.
• a valve which can be used in a particularly flexible manner is provided, by means of which medical devices of different geometries and cross sections can be introduced, and yet a fluid-tight seal can be provided.
• a catheter dilator assembly comprising a
• Figure 1 Schematic side view of a Ein Concretekatheter- dilator arrangement
• Figure 2 schematic side view of the catheter of
• FIG. 3 schematic side view of the dilator of FIG
• FIG. 4 exploded view of the insertion catheter according to FIG. 2;
• FIG. 5 is a perspective view of the valve body of the introducer catheter according to FIG. 4;
• FIG. 6 bottom view of the valve body according to FIG. 5;
• FIG. 7 shows a perspective view of a longitudinal section along the line C-C of the valve body according to FIG. 6;
• FIG. 8 longitudinal section along the line A-A according to FIG. 6;
• FIG. 9 cross-section along the line B-B according to FIG. 6;
• FIG. 10 shows a longitudinal section along the line A - A according to FIG. 6 according to a second embodiment
• FIG. 11 cross-section along the line B-B according to FIG. 6 according to the second embodiment.
• FIG. 12 shows a longitudinal section along the line C-C according to FIG. 6 according to a third embodiment.
• FIG. 1 shows an introducer catheter dilator assembly, generally designated by the reference numeral 2 an introducer catheter 4 and a dilator 6 arranged thereon.
• the introducer catheter 4 has a tube section 8 and a head section 10 (compare Fig. 2).
• the dilator 6 also has a tube section 11 and a head section 12 (see Fig. 3).
• the pipe section 11 of the dilator extends through the pipe section 8 of the
• the head section 10 of the insertion catheter 4 has a fastening section 14.
• the attachment portion 14 comprises a number of spikes 16.
• a valve body 18 is arranged at this attachment portion 14.
• Flange portion 20 with a number of recesses 22, which correspond to the spikes 16, so that the valve body 18 can be plugged by means of a plug connection to the mounting portion 14.
• the outer side 24 of the fastening portion 10 has a number of projections 26. At these projections two holding parts 28, 30 are clipped. The holding parts 28, 30 in turn each have a locking means 32, 34, in the on
• valve body 18 has a closable valve opening 36 which extends from an upper side 37 to a lower side 39 of the valve body 18.
• the valve opening 36 tapers in
• Insertion direction 40 At this taper 42 is followed in the insertion direction 40 directly to a sealing portion 44 at.
• Sealing section 44 lies in the middle region of the
• Valve opening 36 In the insertion direction 40 in turn immediately adjoins the sealing portion 44 an extension 46 at.
• valve opening 36 expands in the insertion direction 40 in the extension 46 while the same degree as the
• Valve opening 36 tapers in the taper 42.
• Valve opening 36 is therefore mirror-symmetrical to a transversely to the insertion direction 40 through the sealing portion 44th
• valve opening 36 and the entire valve body 18 are also mirror-symmetrical to a along the
• the mirror plane 52 extends, as shown in Figure 9, also along the slit-shaped valve opening portion 54 which extends from the sealing portion 44th
• valve body portion 50 (see Fig. 8 and 9) is elliptical.
• the slit-shaped Valve opening portion 54 in the region of the sealing portion 44 extends transversely to the insertion direction 40 along the major axis of this elliptical valve body portion 50th
• the taper 42 and the extension 46 each have two first sections 56, 58, 60, 62, which are mirror-symmetrical to the mirror plane 52 and have the same transverse extension as the slot-shaped valve opening section 54 (cf., in particular, FIGS.
• two second sections 64, 66, 68, 70 adjoin directly the first sections 56, 58, 60, 62, which are of semiconical design and which engage on the corners 72, 74 (FIG. see Fig. 6) of the slit-shaped valve opening portion 54.
• the first sections 56, 58, 60, 62 thereby taper or widen linearly in accordance with FIGS. 7 to 9, arcuately in a concave manner according to FIGS. 10 and 11, and wave-shaped with convex and concave sections according to FIG.
• FIGS. 9 and 10 As shown in FIGS. 9 and 10, FIG. 9
• Seal portion 44 in the insertion direction 40 a length d, while the taper 42 has a length e and the extension 46th have a length f.
• e f and e / d approx. 2.
• the ratio e / d can generally be between 1 and 10.
• the valve opening 36 tapers in the slot direction 43 from a length a to a length b, the ratio a / b being approximately 2.
• the ratio a / b can generally be between 1.1 and 10.
• valve grooves 76,78 for forming a predetermined breaking point.
• Ein 1500katheterrillen 80,82 are provided, which also represent a predetermined breaking point (see Fig. 4).
• the Ein 1500katheterrillen 80, 82 are in the extrusion or injection molding of the
• Catheter 4 is inserted through the insertion catheter 4 into a blood vessel, the catheter 4 can be removed as follows: The head portion 10 of the catheter 4 has two wings 84,86 on. An operator can pull on these wings 84, 86. Then, the valve 18 and the insertion catheter 4 are broken up like a zipper and from the blood vessel
• the valve body 18 consists of silicone with a Shore A hardness between 8-25.
• the valve opening is in the range coated the sealing portion
• the coating may in particular consist of silicone oil.
• the sealing portion 44 undergoes a bias. This is because the elliptic valve body portion 50 projects beyond the receptacle 88 indicated in FIG. 4 along the entire circumference by approximately 0.2 mm in the non-arranged state. In the arranged state, the elliptical valve body portion is thus pinched, so that in particular on the
• Sealing section 44 a compressive stress and thus a
• Valve body portion 50 this tapers in
• Insertion 40 easy, as can be seen in Figure 8.
• the valve body portion 50 is subjected to a compressive stress, which causes the sealing portion 44 a
• valve body 18 is first placed on the attachment portion 14 of the delivery catheter 4. Then the valve body 18 is first placed on the attachment portion 14 of the delivery catheter 4. Then the valve body 18 is first placed on the attachment portion 14 of the delivery catheter 4. Then the valve body 18 is first placed on the attachment portion 14 of the delivery catheter 4. Then the valve body 18 is first placed on the attachment portion 14 of the delivery catheter 4. Then the
• Tube section 8 of the catheter passed and the
• Arranging this introducer catheter dilator assembly 2 in a blood vessel may be accomplished by the Seldinger method
• a vein or artery is opened with a needle, then a guidewire is inserted through the lumen of the needle into the vein or arteries.
• the needle is then withdrawn and the introducer catheter dilator assembly 2 is inserted along the guidewire into the blood vessel. Then the dilator 6 is removed from the insertion catheter 4.
• a medical device such as a catheter through the valve body 18 of the delivery catheter 4 in the blood vessel under fluid-tight

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Heart & Thoracic Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Hematology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Pulmonology (AREA)
• Computer Hardware Design (AREA)
• General Engineering & Computer Science (AREA)
• Computer Security & Cryptography (AREA)
• Software Systems (AREA)
• Theoretical Computer Science (AREA)
• Physics & Mathematics (AREA)
• General Physics & Mathematics (AREA)
• Biophysics (AREA)
• Vascular Medicine (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Media Introduction/Drainage Providing Device (AREA)
• Materials For Medical Uses (AREA)

Applications Claiming Priority (2)

Publications (1)

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Family Applications (1)

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• 2016
  • 2016-04-11 DE DE102016106626.5A patent/DE102016106626A1/de active Pending
• 2017
  • 2017-03-31 BR BR112018070114A patent/BR112018070114A2/pt not_active Application Discontinuation
  • 2017-03-31 US US16/091,407 patent/US10857332B2/en active Active
  • 2017-03-31 WO PCT/EP2017/057771 patent/WO2017178256A1/de active Application Filing
  • 2017-03-31 JP JP2018553462A patent/JP6947479B2/ja active Active
  • 2017-03-31 EP EP17715126.3A patent/EP3442645A1/de active Pending

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