WO2009091419A1 - Dispositif et procédé de rétraction d'aiguille de cathéter - Google Patents

Dispositif et procédé de rétraction d'aiguille de cathéter Download PDF

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Publication number
WO2009091419A1
WO2009091419A1 PCT/US2008/072726 US2008072726W WO2009091419A1 WO 2009091419 A1 WO2009091419 A1 WO 2009091419A1 US 2008072726 W US2008072726 W US 2008072726W WO 2009091419 A1 WO2009091419 A1 WO 2009091419A1
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WO
WIPO (PCT)
Prior art keywords
needle
catheter
aperture
proximal end
tube
Prior art date
Application number
PCT/US2008/072726
Other languages
English (en)
Inventor
John Muri
Gaylene Fisch
Bryan Knodel
Original Assignee
Medco International, Llc
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 Medco International, Llc filed Critical Medco International, Llc
Publication of WO2009091419A1 publication Critical patent/WO2009091419A1/fr

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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
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0606"Over-the-needle" catheter assemblies, e.g. I.V. 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0612Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0631Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
    • 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
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082Catheter tip comprising a tool
    • A61M2025/0095Catheter tip comprising a tool being one or more needles protruding from the distal tip and which are not used for injection nor for electro-stimulation, e.g. for fixation purposes
    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/322Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3232Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means

Definitions

  • the present invention pertains to catheter devices and, more particularly, to retracting catheter needle assemblies.
  • Catheters allow for fluid communication with patients to introduce fluids into a patient and remove blood from a patient. It is not uncommon for catheters to be the over the needle type wherein a needle and catheter are provided in coaxial arrangement. The needle provides a point of entry for the catheter into a patient by inserting the needle into the patient's vein and then sliding the catheter over the needle into the vein of the patient while removing the needle from the vein of the patient.
  • a problem that exists with these prior art catheters do not provide the isolation necessary to prevent the spread of blood borne pathogens of various types or the isolation necessary to prevent fluid exchange between a patient and clinicians in the vicinity. Proper isolation can also prevent contamination of the catheter and the needle from ambient conditions. Providing isolation between the fluids (either bodily fluids or fluids intended to be introduced into a patient) is a feature that has not been provided by many prior art catheters.
  • US Patent No. 7,008404 teaches a catheter tube that fits into a catheter body.
  • An elastic valve is provided inside the catheter tube having an aperture such that the valve is water tight if there is nothing pressing against the aperture.
  • a hollow plug is slideably fitted inside the catheter body to be able to press against the aperture in the elastic valve to open the valve providing fluid communication with the catheter tube.
  • US Patent No. 6,582,402 and US Patent No. 7,344,516 teach a catheter needle retraction device with the catheter needle is attached to a needle hub.
  • a spring is used to bias the needle hub against a distal end of a hollow catheter tube and be moveable away from contact with the needle hub.
  • a catheter is attached to a catheter hub at the distal end of the catheter tube having the catheter needle arranged coaxially therein.
  • a latch actuator is slideably mounted on the catheter tube to activate the latch and allow the needle hub to retract into the catheter tube.
  • the catheter design includes an over the needle catheter needle assembly attached to a catheter housing using a biasing device.
  • the needle is biased by a biasing device that is capable of holding the needle in a fixed position while in an unfired (not yet retracted) state. Once fired, the force applied by the biasing device retracts the needle into a safety tube.
  • the safety needle tube can be a hollow tube portion that is attached to the catheter housing or formed as an integral part of the catheter housing.
  • An actuating mechanism allows the force applied by the biasing device to act upon the needle to retract the needle into a safety needle tube.
  • the actuating mechanism provides a force that alters the position of a surface that is used to bias the needle in the unfired (not yet retracted) state.
  • the needle abuts a portion of the surface in the unfired state that does not allow the needle to pass, thus, keeping the needle in a fixed, biased position.
  • the surface is provided with apertures having cross sectional areas of varying size. An aperture having a smaller cross sectional area used for preventing the needle from traversing the surface and an aperture with a larger cross sectional area allows the needle to pass through the surface. Changing the size of the cross sectional area of the aperture that the needle faces allows the biasing force applied to advantageously be employed to hold the needle in a biased position and also to retract the needle into the safety tube under influence of the biasing force.
  • the actuating device alters the position of the surface allowing the force applied by the biasing mechanism to actuate a retraction of the
  • INCORPORATED BY REFERENCE (RULE 20.6) needle into the proximal end of the hollow safety needle tube.
  • the biasing force is initially acting through the aperture having a smaller cross sectional area.
  • the actuating device adjusts the position of the surface relative to the interface with the needle such that the aperture having a larger cross sectional area within the surface is at the interface with the needle allowing the applied biasing force to retract the needle into the safety tube.
  • the biasing force pulls the needle through the aperture having a larger cross sectional area into the safety tube and the needle is retracted into a fired state.
  • Another embodiment employs an over the needle assembly mounted on the distal end of the catheter housing; the catheter housing has a needle safety tube at its proximal end.
  • a member with a hollow portion is contained within the safety tube.
  • a surface having at a keyhole latch is attached, or part of, the member.
  • the key hole latch within the surface has a cross sectional area that varies in size.
  • the keyhole latch is essentially formed by two overlapping adjacent apertures having different sizes or shapes.
  • the apertures essentially are a larger cross sectional area and a smaller cross sectional area.
  • the differing cross sectional areas can be formed using any geometric figures or combinations thereof, such as ovals, ellipses, circles, rectangles, squares or any combination thereof.
  • the member or the surface is moveable by an actuating mechanism.
  • the needle is placed in a position abutting the surface in the unfired state such that the proximal end of the needle abuts against the surface against the aperture having the smaller diameter.
  • a biasing device is located proximal to the needle with the force form the biasing device being applied through the aperture having a smaller cross sectional area.
  • the actuating device is used to change the relative position of the needle to the surface on the member such that the needle no longer faces the aperture having a smaller cross sectional area.
  • the actuating device forces the instead the proximal end of the needle to face the aperture having a larger cross area of the surface allowing the applied force of the biasing device to retract the needle through the keyhole latch and into the needle safety tube.
  • FIG. Ia is a perspective view of a catheter device having a safety tube with an actuating device
  • FIG. Ib is a cross sectional view of the drawing illustrated in FIG Ia;
  • FIG. 2a is an enlargement of a portion of cross sectional view of the drawing illustrated in FIG. Ib;
  • FIG. 2b illustrates a perspective view of the cross sectional view for the drawing illustrated in FIG. 2a
  • FIG. 3a illustrates a perspective view of the area illustrated in FIG. 2b with the catheter in an advanced position
  • FIG. 3b illustrates a cross sectional view of FIG. 3a
  • FIG. 4a illustrates a perspective view of a catheter body
  • FIG. 4b is a reverse perspective view of that shown in FIG. 4b
  • FIG. 5a is a perspective view of an L-tube
  • FIG. 5b is a reverse perspective view of the L-tube shown in FIG. 5a;
  • FIG. 6a is a perspective view of a push flange
  • FIG. 6b is a reverse perspective view of the push flange shown in FIG. 6a;
  • FIG. 7a is a perspective view of a seal
  • FIG. 7b is a reverse perspective view of the seal shown in FIG. 7a;
  • FIG. 8a is a perspective view of a needle housing
  • FIG. 8b is perspective view of an expanded portion of the needle housing shown in FIG. 8a;
  • FIG. 8c is a perspective view from the opposite side of the needle housing;
  • FIG. 9a is a view of the keyhole slot used to control the retraction of the catheter needle;
  • FIG. 9d is a view similar to that of FIG 9a with a support structure formed
  • FIG. 10 is an exploded view of a catheter system that can be used with the retraction mechanism.
  • FIG. Ia illustrates an embodiment of a catheter system 10 having catheter needle assembly 12 (illustrated is an over-the-needle type catheter assembly although any needle assembly can function as catheter needle assembly 12) attached to a body 2 disposed at the front or distal end of the catheter system 10.
  • the catheter needle assembly 12 includes needle 18 and catheter 9 that can be enclosed by a protective cap 14 to prevent accidental injury from needle 18 and to prevent contamination of needle 18 from ambient conditions.
  • the body 2 is configured with a housing 6 having a safety tube assembly 16 disposed at the rear or proximal end of the catheter system 10.
  • the catheter needle assembly 12 includes needle 18 that is a venous- gauge coring-tipped needle having an angled distal point 20 for percutaneous insertion into a patient and the patient's vascular system, a push flange 22 for advancing the needle 18 and catheter assembly 12. Attached to the catheter needle assembly is a vent cap 14.
  • FIG. Ia illustrates an embodiment of the VantageTM Catheter that incorporates a retraction mechanism that will be described in greater detail below.
  • the catheter shown in FIG. Ia provides increased catheter advance capability.
  • the catheter advance capability can vary for different embodiments and can be double that existing within prior art devices. In one embodiment, this increase in catheter advance capability can be from 0.25" to 0.5".
  • the catheter embodiment shown in FIG. Ia provides an engagement of the needle housing 6 to the body 2 that is strengthened with more engagement length remaining when the catheter (e.g. the needle assembly 12 and the body 2) is in an advanced position form the housing 6.
  • FIG. Ib is a cross sectional view of the drawing illustrated in FIG Ia taken along line
  • the housing 6 and safety tube assembly 16 include a biasing device 26 attached to needle 18 to exert a force onto needle 18 within catheter needle assembly 12.
  • Biasing device 26 is illustrated as a coil spring; however, other biasing materials will be readily apparent to those skilled in the art such as other spring like devices or the use of elastomeric materials.
  • the force of biasing device 26 is applied to needle via extension 28. Extension 28 traverses a slot 30 formed within hollow member 32.
  • slot 30 can be formed in a keyhole-like shape as shown in FIG. 9a having larger aperture 34 with a larger cross sectional area and smaller aperture 36 having a
  • Extension 28 is initially configured to traverse the smaller aperture 36 of keyhole slot 30.
  • the cross sectional area of the needle 18 is larger than the smaller aperture 36; therefore, biasing device 26 exerts a biasing force on needle 18 through extension 28 that holds proximal end of needle 18 in a fixed position abutting the distal end of smaller aperture 36.
  • Actuating device 38 can operate member 32 such that an action on actuating device 38 causes a corresponding action in member 32 to alter the relative position of needle 18 relative to slot 30.
  • Actuating device 38 can be connected to member 32 in a vertical manner such that depressing actuating device 38 causes a corresponding vertical deflection of member 32 while leaving the interface between biasing device 26 and needle 18 substantially stationary allowing needle 18 to become aligned with the larger aperture 34 of the keyhole slot 30. Once the needle 18 is aligned with the larger aperture 34 of the keyhole slot 30, the biasing force exerted through extension 28 on needle 18 by biasing device 26 causes the needle 18 to be retracted into housing 6 and safety tube assembly 16.
  • Fig. Ib illustrates a needle safety tube assembly 16 that can be used to contain biasing device 26 to control the positioning and retraction of needle 18. Needle 18 is held in place by a biasing force applied from biasing device 26.
  • Biasing device 26 can be a spring like device or other biasing mechanism, such as one made from elastomeric material for example, capable of supplying a biasing force.
  • the biasing force can be arranged to hold needle 18 in a position against the distal end of smaller aperture 36 of keyhole slot 30 within the needle safety tube assembly 16 in an unfired state. The biasing force allows the needle 18 to be in a fixed position.
  • Housing 6 has needle safety tube assembly 16 at the proximal end and hollow member 32 with keyhole slot 30 formed at least near the distal end of hollow member 32.
  • the specific positioning of keyhole slot 30 can vary in different embodiments.
  • the position of keyhole slot 30 can be controlled by actuating device 38 to allow movement of the keyhole slot 30 relative to the interface between needle 18 and biasing device 26 to position needle 18 adjacent the larger aperture 34 of keyhole slot 30 in order to retract needle 18 into the needle safety tube assembly 16.
  • Keyhole slot 30 can be formed to have a cross sectional area that changes in size.
  • actuating device 38 is attached to the keyhole slot 30 that is formed at the distal end of member 32. Vertical movement of actuating device 38 is translated into a deflection of keyhole slot 30. Extension 28 in the unfired state traverses the smaller aperture 36 holding the proximal end of needle 18 against the distal side of smaller aperture 36. The biasing force is sufficient to hold needle in place in the unfired state. Depression of actuating device 38 causes a corresponding deflection in member 32 that moves keyhole slot 30 with respect to the interface between biasing device 26 and needle 18.
  • the interface between biasing device 26 and needle 18 will remain stationary during depression of actuating device 38.
  • the interface between biasing device 26 and needle 18 could experience a small movement upon deflection of member 32 after depressing actuating device 38.
  • the depression of actuating device 38 causes a deflection of member 32 that results in the proximal end of needle 18 no longer abutting the distal side of smaller aperture 36 but instead causes proximal end of needle 18 to face larger aperture 34, resulting in the needle being allowed to slide into member 32 under the influence of biasing device 26.
  • the process of implementing changes to aperture sizes within surfaces of hollow member 32 can be advantageously employed to retract needle 18 into housing 6.
  • the force applied by the biasing device 26 can retract needle 18 into hollow member 32 through the aperture 34.
  • the respective positioning of actuating device 38, member 32 and keyhole slot 30 allows a corresponding adjustment in keyhole slot 30 in response to depression of the actuating device 38.
  • Adjusting keyhole slot 30 places the interface between needle 18 and biasing device 26 performed by extension 28 in a different position relative to keyhole slot 30.
  • the interface between needle 18 and biasing device 26 becomes positioned in the larger aperture 34 allowing the force applied by biasing device 26 upon needle 18 to retract needle 18 into hollow member 32.
  • the embodiment shown in the figures illustrates a process that changes surface sizes at the distal end of housing 6 to control positioning of the proximal end of needle 18.
  • Other embodiments are envisioned that allow for changing the position of the interface of needle 18 and biasing device 26 using changing aperture sizes that are not necessarily at the distal end of housing 6. Movement in the actuating device 38 causing movement in member 32, thus
  • FIG. 9b shows a similar view to that illustrated in FIG. 9a with a support structure 37 being formed distally from the keyhole slot 30. Support structure 37 supports the weight of needle 18 as will be discussed further below.
  • FIG. 2a is an enlarged portion of the cross sectional view of the drawing shown in FIG. Ib that more clearly illustrates the interface 40 between needle 18 and biasing device 26 performed by extension 28.
  • Needle 18 can be contained within catheter needle assembly 12 and attached to spring like biasing device 26 by crimping needle 18 to a wire, such as extension 28, to form interface 40. Needle 18 is thereby mounted within body 2 near the proximal end of body 2.
  • the catheter housing 6 has needle safety tube assembly 16 formed at its proximal end with the distal end of catheter housing 6 attached to the proximal end of body 2.
  • extension 28 is a wire that rests in the bottom of keyhole slot 30, which is the smaller aperture 36.
  • the needle 18 can be crimped onto extension 28 and abut the distal side of the smaller aperture 36. While the figure shows a spring like biasing device 26, other basing mechanisms can also be used as biasing device 26 such as elastomeric materials. Persons skilled in the art will understand that biasing device 26 does not necessarily have to be a coil spring, and other biasing mechanisms are envisioned. Additionally, extension 28 does not have to be a wire and other extensions can be employed that transfer the biasing force to needle 18. Also, crimping is not the only manner of attaching extension 28 to needle 18 and any attachment mechanism capable of fixedly holding extension 28 to needle 18 will suffice.
  • Body 2 can have a port formed in or on the body.
  • L-tube port 43 can be formed near its proximal end to provide for an interface with L-tube 23.
  • L-tube port 43 positioning of L-tube port 43 at the proximal end of body 2 and push flange 22 at the distal end of body combined with the length of body 2 provides an increased engagement area between body 2 and housing 6.
  • the increased engagement area makes it easier to use catheter system 10 and provides more strength once the body 2 is in the extended position and either the needle 18 or catheter 9 is inserted into a patient.
  • a female luer connection 24 can be formed within L-tube 23 to provide for fluid communication with the hollow lumens formed by interior regions to L-tube 23, body 2 and needle 18.
  • FIG. 2b provides a perspective view of the area shown in cross sectional view within FIG. 2a. It is readily apparent that there is an increased engagement area provided along body 2 by the positioning of L-tube port 43 towards the proximal end of body 2. The positioning of push flange 22 at the distal end of body and the length of body 2 that overlaps housing 6 serve to provide an increased engagement area between body 2 and housing 6. The positioning of female luer connection 24 on L- tube 23 is shown in perspective. Catheter needle assembly 12 is shown formed at the distal end of body 2 and shown in an un-advanced position.
  • FIG. 3a provides a perspective view of the area illustrated in FIG. 2b with the catheter in an advanced position.
  • the advantage provided by the increased engagement area that by the positioning of L-tube port 43 towards the proximal end of body 2 and the positioning of push flange 22 at the distal end of body and the length of body 2 is clearly evident.
  • the embodiment shown in the figures provides for catheter advancement on the order of about 0.5 of an inch; which is about 3 times that provided by previous catheter designs.
  • the position of female luer connector 24 on to L-tube 23 is shown with the catheter moved into an advanced position.
  • FIG. 3b provides a cross sectional view of the area shown in FIG. 3a.
  • the catheter is shown in an advanced position illustrating the increased engagement area between body 2 and housing 6.
  • FIG. 3b shows the needle 18 within catheter needle assembly 12. As previously discussed, the needle 18 is attached to biasing device 26 through extension 28. Other attachment devices for connecting needle 18 to biasing device 26 will be readily apparent to those skilled in the art.
  • the catheter advancement provided by the embodiment shown in FIG. 3b is many times that provided by previous catheter designs. Seal 44 is inserted into the
  • FIG. 4a illustrates a perspective view of a catheter body 2 with catheter needle assembly 12 formed at the distal end of body 2, L-tube port 43 formed near the proximal end of body 2 and aperture 54 formed at the proximal end of body 2.
  • the catheter needle assembly 12 provides support for needle 18 and provides insulation of the hollow interior portion of body 2.
  • Aperture 54 is used to contain seal 44, Needle 18 to traverse the center of seal 44.
  • Needle 18 is mounted within catheter system 10 such that it traverses through catheter needle assembly 12 and seal 44 within aperture 54 to be connected to extension 28.
  • the needle 18 mounted is this manner provides an interior hollow area within body 2 that is fluidly isolated but still allows needle 18 to slide through the seal 44 and catheter needle assembly 12 to retract needle 18.
  • Connecting rim 57 is formed as an attachment device to engage a compatible mechanism on push flange 22.
  • Protrusion 59 is formed on body 2 to engage a compatible slot within housing 6 to allow body 2 to slide along housing 6.
  • FIG. 4b is a reverse perspective view of the body 2 as shown in FIG. 4b with catheter needle assembly 12 that is used to provide support for needle 18, L-tube port 43 and aperture 54 used to contain seal 44.
  • catheter needle assembly 12 and aperture 54 allow needle 18 to slide through these structures while maintaining a fluid seal within the hollow interior of body 2.
  • Ridge 56 is formed on body 2 to engage a compatible structure on housing 6 and allow body 2 to slide into the advanced position.
  • Connecting rim 57 is formed as an attachment device to engage a compatible mechanism on push flange 22.
  • Protrusion 59 engages a compatible slot within housing 6.
  • FIG. 5a illustrates L-tube 23 in perspective view with flanges 23b used to fixedly attach L-tube 23 to L-tube port 43 on body 2. Ridges 23 a are formed on L- tube 23 to engage check valve 24.
  • FIG. 5b is a reverse perspective view of that shown in FIG. 5a, providing a different view of ridge 23a and flanges 23b.
  • FIG. 6a is a perspective view of a push flange 22 that attaches to catheter needle assembly 12 portion of the body 2. Attachment device 22a is formed on push flange 22 that engages with connecting rim 57 formed on body 2 to fixedly attach push flange 22 to body 2.
  • FIG. 6b is a reverse perspective view of the push flange 22.
  • FIG. 7a is a perspective view of seal 44 that fits into aperture 54 within body 2.
  • the seal 44 has conical protrusion 64 that engages needle 18 while maintaining a fluid seal.
  • FIG. 7b is a reverse perspective view of the seal 44 shown in FIG. 7a illustrating an inverse of conical projection 64.
  • the support structure 37 (as shown in FIG. 9b) can be used to preserve the integrity of the portion of conical protrusion 64 through which needle 18 passes.
  • the integrity of seal 44 can deteriorate during gamma radiation used to cure catheter system 10 and support structure 37 can prevent deformation of conical protrusion 64 from the weight of needle 18.
  • FIG. 8a is a perspective view of housing 6 having needle safety tube 36 formed at the proximal end. Key-slot 39 is formed at the distal end of member 32. Slot 39 receives with protrusion 59 within body 2 to allow body 2 to slide along housing 6. Actuating device 38 is shown as being operatively connected to key-hole slot 30.
  • FIG. 8b is an expanded perspective view of a portion the housing 6 shown in FIG. 8a. Slot 39 is more clearly shown in relative position to actuating device 38, key-hole slot 30 and member 32.
  • FIG. 8c is a perspective view from the opposite side of housing 6 illustrating slot 39.
  • FIG. 9a is a view of the housing 6 as viewed just proximally from the support structure 37 shown in FIG. 9b and looking in the proximal direction.
  • Keyhole slot 30 is formed in member 32 and connected to actuating device 38.
  • a movement depressing actuating device 38 causes a similar movement of keyhole slot 30.
  • Key-hole 30 slot can be formed within member 32 inside housing 6.
  • Different embodiments can employ a rigid member 32 or a flexible member 32
  • Member 32 can be formed to be hollow with a cross sectional area that changes size. Larger aperture 34 and smaller aperture 36 can be used to form a key-hole latch mechanism that is controlled by the movement of actuating device 38.
  • the keyhole can be formed by employing different size apertures in two adjacent areas that have a larger cross sectional area and a smaller cross sectional area. The differing cross sectional areas can be formed using any geometric figures or combinations thereof, such as ovals, ellipses, circles, rectangles squares or any combination thereof.
  • the member 32 is moveable by actuating device 38 within the needle safety tube assembly 16.
  • the needle 18 is placed at the distal side of key-hole slot 30 while in the unfired state such that the proximal end of the needle 18 abuts against the smaller aperture 36 of key-hole slot 30 within member 32.
  • a biasing device 26 located in the needle safety tube assembly 16 asserts a force onto needle 18 through extension wire 28.
  • Actuating device 38 can change the position of member 32 resulting in corresponding movements between actuating device 38 and the key-hole slot 30.
  • actuating device 38 causes the proximal end of needle 18 to face the cross sectional area of the larger aperture 34 of key-hole slot 34 allowing the applied force of the biasing device 26 to retract the needle 18 through the larger cross sectional area into larger aperture 34 of member 32 into a fired state.
  • actuating device 38 is integrated as an extension of member 32 or wherein actuating device is operatively connected to member 32 with a separate piece are both envisioned.
  • FIG. 9b is an illustration similar to that of FIG. 9a but viewed more distally.
  • the support structure 37 is formed distally from the keyhole slot 30 and actuating mechanism 38. It should be noted that support structures for needle 18 can be formed virtually anywhere in the assembly using configurations that will support the weight of needle 18.
  • FIG. 10 illustrates an exploded view of components used to form a catheter system 10 including a needle-less value 75 attached to the female lure connector of the L-tube 23.
  • the exploded view shown in FIG. 10 illustrates a catheter system 10 and the assembly of the various pieces used for a catheter system 10 in the retraction device previously described.
  • Rod 56 attaches biasing device 26 to the rear of safety tube using rod 56 near the proximal end of safety tube 16.
  • Extension wire 28 is
  • L-Tube 23 attaches to housing 6 with o-ring 66 forming a seal that seals the interface between housing 6 and o-ring 66 from ambient conditions while allowing fluid communication between the interior lumens formed within housing 6 and L-tube 23.
  • Single push flange 22 and catheter 9 fit onto housing 6.
  • the cap 14 covers the needle 18 and catheter 9.
  • a needle-less valve 75 mates with the female luer connector on L-tube.
  • L-tube 23 can have a vent 71 with a hydrophobic plug to allow air to vent from the system 10 during Flashback.

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Abstract

L'invention concerne un ensemble aiguille de cathéter monté de manière distale et comprenant un tube de sécurité d'aiguille au niveau de son extrémité proximale. Une surface présente un verrou formé d'ouvertures de différentes dimensions se chevauchant. Le verrou est formé à partir d'ouvertures se chevauchant, comprenant une grande ouverture plus grande que la zone transversale de l'aiguille et une petite ouverture plus petite que la zone transversale de l'aiguille. L'aiguille est polarisée à l'état non déployé de manière que son extrémité proximale vienne en contact avec la petite ouverture de la surface. Un dispositif d'actionnement est utilisé pour changer la position de la surface par rapport à l'aiguille de manière que l'aiguille se retrouve face à la plus grande ouverture permettant à la force appliquée par le dispositif de polarisation de rétracter l'aiguille à travers la plus grande ouverture dans le tube de sécurité de l'aiguille.
PCT/US2008/072726 2007-09-07 2008-08-09 Dispositif et procédé de rétraction d'aiguille de cathéter WO2009091419A1 (fr)

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US95481707P 2007-09-07 2007-09-07
US60/954,817 2007-09-07

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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US20070073237A1 (en) * 2003-07-31 2007-03-29 Aaron Rodd Cannula/catheter introducer

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040019329A1 (en) * 1995-03-07 2004-01-29 Erskine Timothy J. Catheter-advancement actuated needle retraction system
US20070073237A1 (en) * 2003-07-31 2007-03-29 Aaron Rodd Cannula/catheter introducer

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