WO2008030999A2 - Dispositif d'introduction de cathéter de sécurité - Google Patents
Dispositif d'introduction de cathéter de sécurité Download PDFInfo
- Publication number
- WO2008030999A2 WO2008030999A2 PCT/US2007/077825 US2007077825W WO2008030999A2 WO 2008030999 A2 WO2008030999 A2 WO 2008030999A2 US 2007077825 W US2007077825 W US 2007077825W WO 2008030999 A2 WO2008030999 A2 WO 2008030999A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- catheter
- needle
- unit
- housing
- injection port
- Prior art date
Links
- 238000002347 injection Methods 0.000 claims abstract description 74
- 239000007924 injection Substances 0.000 claims abstract description 74
- 230000035515 penetration Effects 0.000 claims abstract description 54
- 230000007246 mechanism Effects 0.000 claims abstract description 21
- 239000008280 blood Substances 0.000 claims abstract description 10
- 210000004369 blood Anatomy 0.000 claims abstract description 10
- 230000008878 coupling Effects 0.000 claims description 53
- 238000010168 coupling process Methods 0.000 claims description 53
- 238000005859 coupling reaction Methods 0.000 claims description 53
- 230000017105 transposition Effects 0.000 claims description 30
- 210000004204 blood vessel Anatomy 0.000 claims description 12
- 238000007789 sealing Methods 0.000 claims description 6
- 239000004033 plastic Substances 0.000 claims description 3
- 229920002379 silicone rubber Polymers 0.000 claims description 3
- 230000009471 action Effects 0.000 abstract description 8
- 239000000470 constituent Substances 0.000 abstract description 7
- 230000003247 decreasing effect Effects 0.000 abstract description 5
- 238000012800 visualization Methods 0.000 abstract description 4
- 238000006073 displacement reaction Methods 0.000 description 3
- 229920001971 elastomer Polymers 0.000 description 3
- 239000000806 elastomer Substances 0.000 description 3
- 230000035939 shock Effects 0.000 description 3
- 230000003993 interaction Effects 0.000 description 2
- 238000001990 intravenous administration Methods 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 230000001012 protector Effects 0.000 description 2
- 230000017531 blood circulation Effects 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 230000008570 general process Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
- 239000011800 void material Substances 0.000 description 1
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
- A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
- A61M25/0637—Butterfly or winged devices, e.g. for facilitating handling or for attachment to the skin
-
- 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
- A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
- A61M25/0631—Devices 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
-
- 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
- A61M25/09—Guide wires
- A61M2025/09116—Design of handles or shafts or gripping surfaces thereof for manipulating guide wires
-
- 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
- A61M25/0693—Flashback chambers
-
- 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
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; 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
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
- A61M5/3257—Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
-
- 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
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; 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
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
- A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
Definitions
- the present invention relates to intravenous catheter placement devices and more particularly to safety compact catheter introducers having reduced length in the storage and transportation positions and a needle retraction mechanism.
- U.S. Patent No. 5,700,250 entitled “Catheter-Advancement Actuated Needle Retracted System” discloses a device including a generally hollow barrel that houses a needle hub having a flash chamber and affixed to a needle. In a pre-use (idle) position the needle extends through a catheter unit and along with a catheter tube protrudes distally of the hollow barrel. A spring is disposed in the barrel to urge the needle hub towards the barrel proximal end.
- There is a latch mechanism including an elongated stem within the hollow barrel and passively actuated during the advance of the catheter tube into patient's blood vessel, allowing retracting the needle unit by the spring into a protection position in the hollow barrel after the catheter emplacement. The passive actuation of the needle hub retraction substantially improves the device operation convenience and heightens device safety. There is also a means for cushioning the needle hub when it is retracted against the barrel proximal end.
- a disadvantage of this device is its considerable length in the pre-use position approximately equal to the sum of the barrel and catheter unit lengths.
- the subsequent arrangement of the spring and needle hub additionally increases the total device length.
- the increase in total device length heightens the package and shipping costs associated with the device.
- the protruding needle sharp point in the pre-use position demands special protection during the device shipping and storage that also heightens the device cost.
- Another disadvantage includes difficulty controlling the device with one hand. This difficulty is caused by the following factors: the relative complex device design with the disposition of the elongated stem within the hollow barrel; the excessively elongated needle with the above mentioned spring location; and a substantial time delay in blood entering the flash chamber.
- Another example is provided in U.S. Patent No. 6,325,781 entitled "Puncturing
- the catheter placement device includes a pre-use (idle) position disposed in a hollow barrel thereby considerably reducing the device length during its shipping and storage.
- the device is provided with a spring that urges the needle unit toward the barrel proximal end.
- the operator uses an actuator to advance the needle and catheter units distally from the pre-use position into a position ready position to a blood vessel puncture position (e.g., a penetration position).
- the operator fixes the position by a manual locking mechanism.
- the operator displaces the catheter unit distally relative to the needle unit, and then manually disengages the lock mechanism, which permits the spring to retract the needle unit into a protection position in the hollow barrel.
- the needle unit In the protection position, the needle unit is fixed by operator's manual action with using the locking mechanism.
- a disadvantage of the device is the absence of a passive actuation means permitting the spring to retract the needle unit into the protection position after the catheter emplacement without any special operator's action.
- Another disadvantage is the necessity for the manual fixation of the needle unit in the protection position.
- Still another disadvantage is the increased device length caused with the subsequent disposition of the needle unit and the spring within the barrel.
- a safety catheter introducer including: a catheter unit including a catheter tube and a catheter hub; a needle unit including a needle and a needle hub, wherein the needle hub is secured to a proximal end of the needle and the needle unit is operable to guide the catheter tube into an associated patient; a handle formed from a hollow elongated housing that serves as a guide for the catheter unit and the needle unit in an idle position, a penetration position and a protection position; a retraction mechanism for retraction of the needle unit from the penetration position into the protection position; a catheter coupling mechanism that provides a releasable connection between the catheter unit with at least one of the needle unit, the needle or the needle hub; a retaining coupling mechanism for releasable affixation of the needle unit to a distal portion of the housing to hold the needle unit in the penetration position during placement of the catheter tube; the catheter unit including an actuator for transposing the catheter unit from the idle position into the penetration position, and a
- Another aspect of the invention relates to the safety catheter introducer, wherein in the idle position the needle is disposed within the catheter tube so that the needle distal sharp point protrudes distally from the distal end of the catheter tube and the catheter unit is disposed in an extreme proximal position, and the needle hub is disposed near the housing proximal end, wherein in the penetration position, the needle unit is releasably affixed to the housing adjacent to a housing distal end and the catheter tube protrudes distally of a housing distal end, wherein in the protection position the needle hub is disposed a position near the housing proximal end and the needle is disposed within the axial limits of the housing.
- Another aspect of the invention relates to including a flash chamber having a viewable portion located within the needle hub.
- Another aspect of the invention relates to the actuator including a catheter unit actuator for advancing the catheter tube into an associated blood vessel after releasable affixation of the needle unit to a distal portion of the housing.
- Another aspect of the invention relates to including a preventing means that prevents accidental transposition of the catheter subassembly actuator distally from the idle position without engaging the catheter subassembly.
- Another aspect of the invention relates to the coupling including a transposition coupling that engages the catheter subassembly actuator with the needle hub at least during the transposition of the catheter subassembly from the idle position into the penetration position.
- Another aspect of the invention relates to the transposition coupling being releasably mounted to allow disengaging of the catheter subassembly actuator from the needle hub.
- Another aspect of the invention relates to the transposition coupling disengaging the needle hub from the catheter subassembly actuator after transposition of the catheter subassembly from the idle position into the penetration position.
- Another aspect of the invention relates to the coupling including a protection coupling for engaging the needle unit with the housing in the protection position.
- Another aspect of the invention relates to the retraction mechanism having a resilient member having a distal end and a proximal end, and the distal end is fastened to the needle hub and its proximal end is fastened at the housing proximal end.
- Another aspect of the invention relates to the resilient member being made of silicon rubber. Another aspect of the invention relates to the resilient member being aligned parallel to the viewing portion of the flash chamber.
- Another aspect of the invention relates to the resilient member being made in the form of a ring and located below the flash chamber viewing portion.
- Another aspect of the invention relates to a sealing of the needle, removing the blood from the needle external surface during transposing the needle unit into the protection position, made as an elastic element and disposed on the catheter subassembly distally of the needle hub on the way of passing the needle.
- Another aspect of the invention relates to the catheter hub being provided with an injection port passing through the housing elongated slit and having a free operation end, wherein the width of the housing elongated slit is less than diameter of the operation end of injection port.
- Another aspect of the invention relates to the injection port having a cover that substantially closes the injection port operation end, and the cover includes a base part and a cap connected to each other by a link, wherein the link allows for a pivoting movement of the cap between its closed and open positions.
- the base part including a lower portion serving for fixing the cover on the injection port and an upper portion forming a cavity covered with the cap and providing a closed space around the injection port with a gap between the injection port and inner walls of the cavity and cap.
- Another aspect of the invention relates to the cover including a springy element disposed between the base part and cap for imparting a force on the cap to position the cap in one or more open or closed positions.
- Another aspect of the invention relates to the catheter hub having wings for fixing the catheter unit to an associated patient, wherein wings are foldable due to the presence of at least one elongated bend portion disposed at a fastening zone.
- each of the wings having a free portion beginning substantially from the fastening zone to the catheter hub and extending more than 3 mm proximally.
- Another aspect of the invention relates to an upper edge of the wings being in a folded state and substantially lower than an upper surface of the catheter hub.
- Another aspect of the invention relates to the distance between external lateral sides of the wings in the folded state approximately equals the diameter of a catheter luer-lock thread.
- a catheter unit including: a catheter tube and a catheter hub affixed to a proximal end of the catheter tube and provided with an injection port having an injection port operation end, having: a cover closing the injection port operation end, wherein the cover includes a base part and a cap connected with one another by a link that supports a pivoting movement of the cap between an opened and a closed position, wherein the base part includes a lower portion for fixing the cover to the injection port and an upper portion forming a cavity covered with the cap and providing a closed space around the injection port having a gap between the injection port and inner walls of the cavity and cap for preventing contact between the injection port with the surfaces of the cover.
- Another aspect of the invention relates to the link including a cap pivot.
- the injection port includes a springy element disposed between the base part and cap for imparting a force the cap and fixing the cap in a cap position.
- Another aspect of the invention relates to the lower portion of the cover base part being a cylindrical portion adapted for stretching over the injection port to provide the needed fixation of the cover to the injection port by friction forces.
- cover, base part and cap being made of plastic and are integral.
- a safety catheter introducer including: a hollow elongated housing; a catheter subassembly movably disposed in the housing, wherein the catheter subassembly includes a catheter unit having a catheter tube and a catheter hub affixed to a proximal end of the catheter tube and a needle unit including a needle having a needle distal sharp point and a needle proximal end to which a needle hub with a flash chamber is attached, the catheter hub is affixed to a proximal end of the catheter tube and provided with an injection port having an injection port operation end, having: a cover closing the injection port operation end, wherein the cover includes a base part and a cap connected with one another by a link that supports a pivoting movement of the cap between an opened and a closed position, wherein the base part includes a lower portion for fixing the cover to the injection port and an upper portion forming a cavity covered with the cap and providing a closed space around the injection port having a gap between
- Another aspect of the invention relates to the safety catheter introducer, wherein in the idle position the needle is disposed within the catheter tube so that the needle distal sharp point protrudes distally from the distal end of the catheter tube and the catheter unit is disposed in an extreme proximal position, and the needle hub is disposed near the housing proximal end, wherein in the penetration position, the needle unit is releasably affixed to the housing adjacent to a housing distal end and the catheter tube protrudes distally of a housing distal end, wherein in the protection position the needle hub is disposed a position near the housing proximal end and the needle is disposed within the axial limits of the housing
- Fig. 1 shows the side general view of the safety catheter introducer in the idle position.
- Fig. 2 shows the top general view of the safety catheter introducer in the idle position.
- Fig. 3 shows the cross-sectional view of the safety catheter introducer in the idle position.
- Fig. 4 shows the cross-sectional view of the safety catheter introducer in the beginning of its transposition from the idle position into the penetration position by the catheter subassembly actuator.
- Fig. 5 shows the cross-sectional view of the safety catheter introducer at the instant its transposition from the idle position into the penetration position is completed.
- Fig. 6 shows the cross-sectional view of the safety catheter introducer in the penetration position.
- Fig. 7 shows the cross-sectional view of the safety catheter introducer at the end of the catheter advance by the catheter unit actuator and the needle retraction into the protection position by the springy retraction means.
- Fig. 8 shows the cross-sectional views of the safety catheter introducer after the catheter emplacement and disengaging the introducer housing from the catheter unit.
- Fig. 9 shows the general top view of the catheter unit.
- Fig. 10 shows the general side view of the catheter unit.
- Fig. 11 shows the general back view of the catheter unit.
- Fig. 12 shows the cross-sectional view of the injection port cover in the closed state.
- Fig. 13 shows the cross-sectional view of the injection port cover in the opened state.
- the present invention is related to a safety catheter introducer of compact design having decreased length in the shipping and storage states that is also equipped with a passively actuated retraction mechanism for needle retraction into a protected position after use.
- the safety catheter permits convenient control of the catheter introducer by an associated user using one hand.
- the safety catheter also permits automatic fixation of introducer constituents in penetration and protection positions without any special operator's actions.
- the safety catheter includes an improved flash chamber for visualization at the instant an associated patient's blood enters the flash chamber.
- the safety catheter further includes a safety covering of an injection port that substantially eliminates infecting of the injection port by accidental contact with personnel.
- the safety catheter introducer has a hollow elongated housing serving as an introducer holder, and a catheter subassembly movably disposed in the housing.
- the catheter subassembly includes: a catheter unit including a catheter tube and a catheter hub affixed to a proximal end of the catheter tube; and a needle unit including a needle having a needle distal sharp point and a needle proximal end to which a needle hub with a flash chamber is attached.
- the catheter subassembly is disposed in the housing and may be positioned in the housing in an idle position wherein the catheter subassembly is disposed within the housing axial limits, and a penetration position wherein the catheter subassembly is releasably affixed to the housing adjacent to a housing distal end and the catheter tube protrudes distally of a housing distal end.
- the safety catheter introducer also includes an actuation means for the control of the catheter subassembly and includes: a catheter subassembly actuator located on an elastic oscillating lever for transposing the catheter subassembly from the idle position into the penetration position, and a catheter unit actuator for the advance of the catheter tube into blood vessel only after the releasable affixation of the needle unit to a distal portion of the housing.
- actuation means for the control of the catheter subassembly and includes: a catheter subassembly actuator located on an elastic oscillating lever for transposing the catheter subassembly from the idle position into the penetration position, and a catheter unit actuator for the advance of the catheter tube into blood vessel only after the releasable affixation of the needle unit to a distal portion of the housing.
- the housing generally serves as a guide and a receptacle for the catheter subassembly and as a protector for the needle.
- the needle distal sharp point is protected from contact with persons when the needle hub is located near the housing proximal end.
- the housing wall has an elongate slit through which the catheter subassembly actuator passes outwardly thereby providing the accessibility of the catheter subassembly actuator for the outward control.
- the catheter introducer is also provided with a preventing means that substantially eliminates accidental transposition of the catheter subassembly actuator from the idle position distally without engaging with the needle unit.
- the preventing means includes two stopping elements, which are located on the elastic oscillating lever connected with the catheter subassembly actuator. In the idle position the stopping elements enter the recesses in the lateral walls of the housing elongated slit thereby preventing the distal displacement of the catheter subassembly actuator until the operator presses the oscillating lever downwardly.
- the safety catheter introducer has a compact design characterized with the decreased length in the shipping and storage state.
- the safety catheter introducer further includes a protection position disposition of the needle after the catheter emplacement and characterized with the location of the needle hub in its extreme proximal position near the housing proximal end.
- the catheter introducer also includes a springy retraction means for the retraction of the needle unit from the penetration position into the protection position.
- the retraction means retracts the needle unit from the penetration position into the protection position.
- the automatically actuated retraction means heightens the safety and operation convenience of the catheter introducer.
- the retraction means typically has a resilient member made of elastomer in the form of a ring and located below the flash chamber viewing portion.
- the resilient member does not cause the housing lengthening and does not hinder the flash chamber visualization.
- the resilient member is fastened to the needle hub as well as to the housing proximal end.
- the resilient member may be in the form of an elastic ring that is parallel to and is generally located under the flash chamber. Thus, the total length is not increased and there is no disturbance to the visualization of the blood inside the flash chamber.
- the catheter introducer is provided with the following coupling: a transposition coupling engaging the catheter subassembly actuator with the needle hub at least during the transposition of the catheter subassembly from the idle position into the penetration position; a catheter coupling providing a releasable connection of the catheter unit with another elements of the catheter subassembly; a retaining coupling designed for the releasable affixation of the needle unit to the housing distal portion to hold the needle unit in the penetration position during the catheter tube placement and allowing releasing the needle unit by the retraction means actuator; a protection coupling designed for engaging the needle unit with the housing in the protection position.
- the catheter introducer has a cushioning means capable of cushioning against shock of the needle hub on a housing distal face during the needle unit retraction.
- the constituents of the protection coupling are operating also as the cushioning means (e.g., protrusion and engagement element).
- the cushioning means e.g., protrusion and engagement element
- the sequence of the catheter introducer operation is as follows. The operator presses downwardly onto the elastic oscillating lever to deactivate the preventing means and activate the transposition coupling, and transposes the catheter subassembly from the idle position into the penetration position by the catheter subassembly actuator.
- the transposition coupling maintains the engagement of the catheter subassembly actuator with the needle hub.
- the retaining coupling affixes the needle unit to a distal portion of the housing and the transposition coupling is released disengaging the catheter subassembly actuator from the needle hub.
- the operator advances the catheter tube into a blood vessel by the catheter unit actuator.
- the catheter tube reaches its finish position in the blood vessel and the retaining means actuator is actuated disengaging the retaining coupling and allowing the needle unit retraction into the protection position by the retraction means.
- the needle unit is fixed in the protection position by the protection coupling. In doing so, the protection coupling fulfils also the part of the cushioning means.
- the catheter subassembly actuator remains at the housing distal end.
- the fixation of the introducer constituents in the penetration and protection positions occurs automatically without any special operator's actions, and all control operations are implemented one-handedly by operator's action onto the catheter subassembly actuator and the catheter unit actuator.
- the safety catheter introducer is provided with a sealing of the needle, removing the blood from the needle external surface during the needle retraction into the protection position, made as an elastic element and disposed on the catheter subassembly distally of the needle hub on the way of passing the needle.
- the safety catheter introducer has the catheter hub provided with an injection port passing through a housing elongated slit and having a free operation end whose diameter is more than the width of the housing elongated slit due to a narrowing of the injection port disposed at the level of the housing elongated slit.
- the mentioned narrowing is the novelty, allowing to restrict the elongated slit width and thereby to strengthen the housing and to improve the needle protection.
- the injection port has a cover closing the injection port operation end and including a base part and a cap connected with one another by a link, which provides a capability of pivoting movement of the cap between its closed and open positions.
- the cover includes a springy element disposed between the base part and cap and providing forcing the cap and subsequent fixing it in one of the cap positions after traversing by the cap a mid position between the closed and opened positions.
- the base part includes a lower portion serving for fixing the cover to the injection port, and an upper portion forming a closed cavity around the injection port with a substantial gap between the injection port and the inner walls of the cavity and cap. The closed cavity allows elimination of a contact of the injection port with the surfaces of the cover, which may have accidental contact with personnel. As a result, infecting the injection port is avoided.
- the catheter hub has wings for fixing the catheter unit to patient skin, therewith the wings are foldable due to the presence of their elongated bend portions, which are disposed at zones of fastening the wings to the catheter hub and made as thinned wall portions.
- the wings in a folded state are contained inside of the hollow housing due to the limited width, therewith the needed total wing surface to be contacted with patient's skin is obtained at the expense of wing free portions extending proximally from the catheter hub more than 3 mm.
- Safety catheter introducer 20 is illustrated in Figures 1 to 8.
- the safety catheter introducer 20 includes a hollow elongated housing 21 serving as an introducer holder, and catheter subassembly 22 movably disposed in housing 21.
- Housing 21 is provided with external lateral ribs 75 for convenient holding of the introducer 20 by operator's hand.
- Catheter subassembly 22 includes of: catheter unit 23 including catheter tube 24 and catheter hub 25 affixed to the proximal end of catheter tube 24; and needle unit 26 including needle 27 having needle distal sharp point 28 and the needle proximal end to which needle hub 29 with flash chamber 30 is attached.
- Flash chamber 30 is communicated with air through vent diaphragm 76 made of porous material penetrated for air and non-penetrated for blood, (e.g., to allow air flow therethrough) (e.g., to block blood flow therethrough).
- vent diaphragm 76 made of porous material penetrated for air and non-penetrated for blood, (e.g., to allow air flow therethrough) (e.g., to block blood flow therethrough).
- Catheter subassembly 22 includes an actuation means, designed for the control of catheter subassembly 22 and including: catheter subassembly actuator 31 located on an elastic oscillating lever 32 and designed for transposing catheter subassembly 22 from the idle position into the penetration position, and catheter unit actuator 33 designed for the advance of catheter tube 24 into blood vessel only after the releasable affixation of needle unit 26 to the distal portion of housing 21.
- the elastic oscillating lever is a lever that has a characteristic of being resilient and/or flexible. The presence of two mentioned actuators provides an optimal sequence of operation of the catheter introducer constituents.
- Housing 21 serves as a guide and a receptacle for catheter subassembly 22 and as a protector for needle 27, therewith needle distal sharp point 28 is protected from any contact with persons, when needle hub 29 is located near the housing proximal end (figs. 1-4, 7, 8).
- the housing wall has elongated slit 34 through which catheter subassembly actuator 31 passes outwardly thereby providing the accessibility of catheter subassembly actuator 31 for the outward control.
- the catheter introducer is provided with a preventing means eliminating the capability of accidental transposition of catheter subassembly actuator 31 distally from the idle position without engaging with needle unit 26.
- the preventing means includes two stopping elements 35, 36, which are located on elastic oscillating lever 32. In the idle position stopping elements 35, 36 enter recesses 37, 38 respectively in the lateral walls of housing elongated slit 34 and prevent catheter subassembly actuator 31 from the distal displacement until the operator presses oscillating lever 32 downwardly. Therewith the mentioned pressing downwardly leads to the engagement of catheter subassembly actuator 31 with needle unit 26 allowing the displacement distally of catheter subassembly actuator 31 along with needle unit 26 and catheter subassembly 22 as a whole.
- catheter introducer 20 has a compact design characterized with the decreased length in the idle position, i. e. in the shipping and storage positions.
- needle unit 26 is releasably affixed to the housing distal end portion.
- the safety catheter introducer 20 is shown in the protection position in Figures 7 and 8.
- the needle unit 26 is generally placed in the protection position after the catheter emplacement.
- the protection position is generally characterized with the location of needle hub 29 in its extreme proximal position near the housing proximal end.
- the safety catheter introducer 20 further includes a springy retraction means 39.
- the springy retraction 39 may be a spring, spring-like structure, elastomer or any other type of device or component that is capable of imparting a retraction force.
- the springy retraction means (also identified herein as retraction means) is designed for the retraction of needle unit 26 from the penetration position into the protection position and presenting resilient member 39 made of elastomer, for example of silicon rubber, in the form of a ring fastened to needle hub 29 as well as to the proximal end of housing 21 through hook 80 of housing proximal plug 54.
- the resilient member 39 may be located in parallel to the viewing portion of flash chamber 30. In one embodiment, the resilient member 39 is located below the flash chamber 30. As a result, resilient member 39 does not cause the housing lengthening and does not provide an obstruction to viewing of the flash chamber by the associated user.
- the safety catheter introducer 20 further includes a releasing means.
- the releasing means includes a retraction means actuator 40 which is automatically actuated by the movement of catheter unit 23 relative to 21 housing from the penetration position into the blood vessel.
- the retraction means actuator may disengage the retaining coupling to allow the retraction of needle unit 26 from the penetration position into the protection position. As a result, the retraction means retracts needle unit 26 from the penetration position into the protection position.
- the automatically actuated retraction means heightens the safety and operation convenience of catheter introducer 20.
- the actuation means may be a single unit 41 , which in the idle and penetration positions is releasably fastened to catheter hub 25.
- Single unit 41 has base member 42 movably mounted in housing elongated slit 34 through guiding groove 77, as shown in Figure 7, located on the outer lateral walls of base member 42.
- base member 42 has ledge 78, which serves as a limiter of the distal transposition of single unit 41 , when ledge 78 is butted up against shoulders 79 in housing elongated slit 34, as shown in Figures 2 and 3.
- Base member 42 generally protrudes upwardly of elongated slit 34 and serves as a base for a pivot of elastic oscillating lever 32 carrying catheter subassembly actuator 31.
- Catheter unit actuator 33 is made as a projection on the distal portion of base member 42.
- Retraction means actuator 40 is located on the lower side of single unit 41 and made in the form of a downwardly directed cam.
- Safety catheter introducer 20 is provided with a transposition coupling, a catheter coupling, a retaining coupling and a protection coupling.
- the transposition coupling engages catheter subassembly actuator 31 with needle hub 26 at least during the transposition of catheter subassembly 22 from the idle position into the penetration position.
- the transposition coupling includes two contacting surfaces 43 and 44 interacting during transposing catheter subassembly 22 from the idle position into the penetration position. Specifically, one contacting surface 43 is located on the proximal face of needle unit 26 and the other contacting surface 44 is located on the distal side of downwardly directed projection 45 of oscillating lever 32. Therewith, in the idle position, contacting surface 44 of oscillating lever 32 is located above contacting surface 43 of needle unit 26 beyond the contact zone and can be introduced into the contact zone by operator's pressure downwardly onto oscillating lever 32.
- the catheter coupling provides the releasable connection of catheter unit 23 with other elements of catheter subassembly 22.
- the catheter coupling includes forwardly projecting conic portion 46 of single unit 41 and conic internal surface 47 of catheter hub 25 coupled with projecting conic portion 46 by friction forces.
- the retaining coupling is designed for the releasable affixation of needle unit 26 to the housing distal portion to hold needle unit 26 in the penetration position during the catheter tube placement, allowing releasing needle unit 26 by retraction means actuator 40.
- the retaining coupling includes deepening 48 on the lower distal surface of needle unit 26 and ridge 49 directed upwardly, located on resilient leg 50 disposed at the distal lower portion of housing 21 and adapted to the interconnection with needle unit deepening 48.
- the deepening 48 may take any desired form.
- the deepening 48 may be a recess, a void, a slot or a cutout.
- the protection coupling is designed for engaging needle unit 26 with housing 21 in the protection position.
- the protection coupling includes engagement element 51 on the lower proximal surface of needle unit 26 and protrusion 52 directed upwardly, located on resilient leg 53 of distal plug 54 of housing 21. Engagement element 51 and protrusion 52 are adapted to the engagement in the end of the needle unit retraction to lock needle unit 26 in the protection position.
- Catheter introducer 20 also includes a cushioning means capable of cushioning against shock of needle hub 29 on a housing distal face during the needle unit retraction.
- a cushioning means capable of cushioning against shock of needle hub 29 on a housing distal face during the needle unit retraction.
- the sequence of the catheter introducer operation is following.
- the operator presses downwardly onto elastic oscillating lever 32 to deactivate the preventing means by withdrawing stopping elements 35, 36 from recesses 37, 38 and activate the transposition coupling by introducing contacting surfaces 43 and 44 into contact.
- the operator transposes catheter subassembly 22 from the idle position into the penetration position acting onto catheter subassembly actuator 31. In doing so, the transposition coupling maintains the engagement of catheter subassembly actuator 31 with needle hub 29.
- ridge 49 of the retaining coupling enters deepening 48 thereby affixing needle units 26 to the distal portion of housing 21 , and, when the operator ceases pressing onto lever 32, contacting surfaces 43, 44 of the transposition coupling disengage (fig. 6) thereby disengaging catheter subassembly actuator 31 from needle hub 29. Then operator advances catheter tube 24 into blood vessel by catheter unit actuator 33. In the end of this advance, catheter tube 24 reaches its finish position in the blood vessel, and retaining means actuator 40 disengages ridge 49 and deepening 48 of the retaining coupling allowing the needle unit retraction into the protection position by resilient member 39.
- Needle unit 26 is fixed in the protection position as a result of the engagement of protrusion 52 and engagement element 51 of the protection coupling. In doing so, protrusion 52 and engagement element 51 of the protection coupling fulfils also the part of the cushioning means.
- actuation means single unit 41 including catheter subassembly actuator 31 remains at the housing distal end.
- Safety catheter introducer 20 is provided with sealing 54 of needle 27, removing the blood from the needle external surface during the needle retraction into the protection position.
- Sealing 54 is made as an elastic element and disposed on catheter subassembly 22 distally of needle hub 29 on the way of passing needle 27.
- sealing 54 is made as a valve occluding a passage for the needle catheter subassembly 22 after the needle unit retraction into the protection position to prevent the blood exit from catheter unit 23 outward.
- Catheter hub 25 of safety catheter introducer 20 is provided with injection port 55 passing through housing elongate slit 34 and having free operation end 56 whose diameter is more than the width of housing elongated slit 34 due to narrowing 57, as shown in Figure 11 , of the injection port disposed at the level of housing elongated slit 34.
- Narrowing 57 allows restriction of the elongated slit width and thereby to strengthens the housing and improves the needle protection.
- Injection port 55 has cover 58 closing injection port operation end 56 and including base part 59 and cap 60 connected with one another by link 71.
- Link 71 provides the capability of pivoting movement of cap 60 between its closed and opened positions, as shown in Figures 12 and 13, respectively.
- Cover 58 includes springy element 61 disposed between base part 59 and cap 60 and providing forcing cap 60 and subsequent fixing it in the opened or closed positions after traversing by cap 60 a mid position between the closed and opened positions.
- Base part 59 consists of lower portion 62 serving for fixing cover 58 to injection port 55, and upper portion 63 forming closed cavity 64 around injection port 55 with a substantial gap between injection port 55 and the inner walls of cavity 64 and cap 60.
- the cavity 64 substantially eliminates contact of injection port 55 with the surfaces of cover 60, thereby reducing the risk of accidental contact with personnel. As a result, infection of the injection port is avoided.
- Lower portion 62 of cover base part 59 is generally made as a cylindrical portion adapted for stretching over injection port 55 with some effort to provide the needed fixation of cover 58 to injection port 55 by friction forces. All of the components of cover 58 may be made of plastic as a single unit.
- the catheter hub has wings 65, 66 for fixing catheter unit 23 to patient skin.
- the wings 65, 66 are foldable due to the presence of elongated bend portions 67, 68, which are disposed at zones of fastening the wings to catheter hub 25 and made as thinned wall portions.
- wings 65, 66 are in a folded state and are contained inside of hollow housing 21 due to the limited width of the wings.
- the needed total wing surface to be contacted with patient's skin is obtained at the expense of wing free portions 69, 70 extending proximally from the catheter hub more than 3 mm.
- any recitation of "means for” is intended to evoke a means-plus-function reading of an element and a claim, whereas, any elements that do not specifically use the recitation "means for”, are not intended to be read as means-plus-function elements, even if the claim otherwise includes the word "means”.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
L'invention concerne un dispositif d'introduction de cathéter de sécurité (20) de conception compacte, ayant une longueur inférieure dans les états de transport et de stockage, qui est également pourvu d'un mécanisme de rétraction actionné de manière passive pour une rétraction d'aiguille dans une position protégée après utilisation. Le cathéter de sécurité permet une commande pratique du dispositif d'introduction de cathéter par un utilisateur associé utilisant une main. Le cathéter de sécurité permet également une fixation automatique des éléments constitutifs du dispositif d'introduction dans des positions de pénétration et de protection sans aucune action spéciale de l'opérateur. Le cathéter de sécurité comprend une chambre flash améliorée (30) pour une visualisation au moment où le sang d'un patient associé entre dans la chambre flash. Le cathéter de sécurité comprend en outre un recouvrement de sécurité (60) d'un orifice d'injection (55) qui élimine sensiblement une infection de l'orifice d'injection par un contact accidentel avec le personnel.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US82484706P | 2006-09-07 | 2006-09-07 | |
US60/824,847 | 2006-09-07 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2008030999A2 true WO2008030999A2 (fr) | 2008-03-13 |
WO2008030999A3 WO2008030999A3 (fr) | 2008-09-18 |
Family
ID=39158072
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2007/077825 WO2008030999A2 (fr) | 2006-09-07 | 2007-09-07 | Dispositif d'introduction de cathéter de sécurité |
Country Status (1)
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WO (1) | WO2008030999A2 (fr) |
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