WO2008030999A2

WO2008030999A2 - Safety catheter introducer

Info

Publication number: WO2008030999A2
Application number: PCT/US2007/077825
Authority: WO
Inventors: Sergey Popov
Original assignee: Sklar, Warren, A.; Serpomed Ltd
Priority date: 2006-09-07
Filing date: 2007-09-07
Publication date: 2008-03-13
Also published as: WO2008030999A3

Abstract

Disclosed is a safety catheter introducer (20) 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 (30) for visualization at the instant an associated patient's blood enters the flash chamber. The safety catheter further includes a safety covering (60) of an injection port (55) that substantially eliminates infecting of the injection port by accidental contact with personal.

Description

SAFETY CATHETER INTRODUCER

FIELD OF THE INVENTION

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.

BACKGROUND OF THE INVENTION

The protection of a contaminated needle sharp point from contact with personnel after catheter emplacement is one of the main demands faced by manufacturers of intravenous catheter placement devices. In this connection, many modern catheter placement devices provide a mechanism to protect personnel from the needle sharp point as part of the general process of catheter placement.

For example, 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. Moreover, 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

Device", which discloses a catheter placement device including a needle unit and a catheter unit. 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 then fixes the position by a manual locking mechanism. After vein puncture, 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.

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.

SUMMARY OF THE INVENTION

In view of the aforementioned shortcomings associated with the prior art, there is a need in the art for 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.

One aspect of the present invention relates to 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 release mechanism that is automatically actuable by movement of the catheter unit relative to the housing when the needle unit is in the penetration position from the penetration position into the protection position by disengaging the retaining coupling mechanism to allow the retraction of the needle unit from the penetration position into the protection position.

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.

Another aspect of the invention relates to 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.

Another aspect of the invention relates to 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.

One aspect of the invention relates to 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.

Another aspect of the invention relates to 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.

Another aspect of the invention relates to the cover, base part and cap being made of plastic and are integral.

One aspect of the invention relates to 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 the injection port and inner walls of the cavity and cap for preventing contact between the injection port with the surfaces of the cover and the catheter subassembly is operable in the housing for disposition in an idle position, a penetration position and a protection position.

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

Other systems, devices, methods, features, and advantages of the present invention will be or become apparent to one having ordinary skill in the art upon examination of the following drawings and detailed description. It is intended that all such additional systems, methods, features, and advantages be included within this description, be within the scope of the present invention, and be protected by the accompanying claims.

It should be emphasized that the term "comprise/comprising" when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof."

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other embodiments of the invention are hereinafter discussed with reference to the drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present invention. Likewise, elements and features depicted in one drawing may be combined with elements and features depicted in additional drawings. Moreover, in the drawings, like reference numerals designate corresponding parts throughout the several views.

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.

DETAILED DESCRIPTION OF THE INVENTION

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. The presence of the catheter subassembly actuator and the catheter unit actuator provides an optimal sequence of the operation of the catheter introducer constituents.

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.

In the idle position, the needle is disposed within the catheter tube so that the needle distal sharp point protrudes distally of the catheter tube, the catheter unit is disposed in its extreme proximal position, and the needle hub is disposed near the housing proximal end. As a result, the safety catheter introducer has a compact design characterized with the decreased length in the shipping and storage state.

In the penetration position, the needle unit is releasably affixed to the housing distal end portion. 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. There is also a releasing means, made as a retraction means actuator, to be automatically actuated by the movement of the catheter unit relative to the housing from the penetration position into the blood vessel and designed for disengaging the retaining coupling to allow the retraction of the needle unit from the penetration position into the protection position. As a result, 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. As distinct from the prior art, 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. Therewith, the constituents of the protection coupling are operating also as the cushioning means (e.g., protrusion and engagement element). For example, when the needle retracts back, the interaction of the protrusion and engagement absorbs the shock of the needle retraction into the housing. 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. In doing so, the transposition coupling maintains the engagement of the catheter subassembly actuator with the needle hub. In the movement end, 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. Then the operator advances the catheter tube into a blood vessel by the catheter unit actuator. In the end of this advance, 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. Therewith, the catheter subassembly actuator remains at the housing distal end. Thus, 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. In the idle position, 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. The detailed description of the present invention is offered with the references made to the drawings in figs. 1 to 13.

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). There are following relative positions of catheter subassembly 22 and housing 21 : an idle position, as shown in Figures 1 to 3, wherein the catheter subassembly 22 is disposed within the axial limits of housing 21 ; and a penetration position, shown in Figure 6, wherein catheter subassembly 22 is releasably affixed to housing 21 adjacent to the housing distal end, and catheter tube 24 protrudes distally of the housing distal end. 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.

In the idle position, shown in Figures 1 to 3, needle 27 is disposed within catheter tube 24 so that needle distal sharp point 28 protrudes distally of catheter tube 24, catheter unit 23 is disposed in its extreme proximal position, and needle hub 29 is disposed near the housing proximal end. As a result, catheter introducer 20 has a compact design characterized with the decreased length in the idle position, i. e. in the shipping and storage positions.

In the penetration position, shown in Figure 6, 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. Therewith, 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. For example, 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. Therewith, the role of the cushioning means is fulfilled with protrusion 52 and engagement element 51 of the protection coupling as a result of its interaction 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. Then 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. In the transposition end, 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. Therewith, actuation means single unit 41 including catheter subassembly actuator 31 remains at the housing distal end. Thus, 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 catheter subassembly actuator 31 and then onto catheter unit actuator 33.

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. In version embodiment (not shown), 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. In the idle position, 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.

Although the invention has been shown and described with respect to certain preferred embodiments, it is obvious that equivalents and modifications will occur to others skilled in the art upon the reading and understanding of the specification. The present invention includes all such equivalents and modifications, and is limited only by the scope of the following claims. Specific embodiments of an invention are disclosed herein. One of ordinary skill in the art will readily recognize that the invention may have other applications in other environments. In fact, many embodiments and implementations are possible. The following claims are in no way intended to limit the scope of the present invention to the specific embodiments described above. In addition, 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".

Claims

CLAIMSWhat is claimed is:

1. A safety catheter introducer (20) comprising: a catheter unit (23) including a catheter tube (24) and a catheter hub (25); a needle unit (26) including a needle (27) and a needle hub (29), 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 (21) 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 (39) 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 (31) for transposing the catheter unit from the idle position into the penetration position, and a release mechanism that is automatically actuable by movement of the catheter unit relative to the housing when the needle unit is in the penetration position from the penetration position into the protection position by disengaging the retaining coupling mechanism to allow the retraction of the needle unit from the penetration position into the protection position.

2. The safety catheter introducer of claim 1 , 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.

3. The safety catheter introducer of any of claims 1-2 further including a flash chamber having a viewable portion located within the needle hub.

4. The safety catheter introducer of any of claims 1-3, wherein the actuator includes 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.

5. The safety catheter introducer of any of claims 1-4 further including a preventing means that prevents accidental transposition of the catheter subassembly actuator distally from the idle position without engaging the catheter subassembly.

6. The safety catheter introducer of any of claims 1-5, wherein the coupling includes 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.

7. The safety catheter introducer of claim 6, wherein the transposition coupling is releasably mounted to allow disengaging of the catheter subassembly actuator from the needle hub.

8. The safety catheter introducer of claim 7, wherein, the transposition coupling disengages the needle hub from the catheter subassembly actuator after transposition of the catheter subassembly from the idle position into the penetration position.

9. The safety catheter introducer of any of claims 1-8, wherein the coupling includes a protection coupling for engaging the needle unit with the housing in the protection position.

10. The safety catheter introducer of any of claims 1-9, wherein the retraction mechanism has 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.

11. The safety catheter introducer of any of claims 8-10, wherein the resilient member is made of silicon rubber.

12. The safety catheter introducer of claim 11 , wherein the resilient member is aligned parallel to the viewing portion of the flash chamber.

13. The safety catheter introducer of claim 12, wherein the resilient member is made in the form of a ring and located below the flash chamber viewing portion.

14. The safety catheter introducer of any of claims 1-13, wherein there is 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.

15. The safety catheter introducer of any of claims 1-14, wherein the catheter hub is 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.

16. The safety catheter introducer of claim 15, wherein the injection port has 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.

17. The safety catheter introducer of claim 16, wherein the base part includes 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.

18. The safety catheter introducer of claim 17, wherein the cover includes 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.

19. The safety catheter introducer of any of claims 1-18, wherein the catheter hub has 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.

20. The safety catheter introducer of claim 19, wherein each of the wings has a free portion beginning substantially from the fastening zone to the catheter hub and extending more than 3 mm proximally.

21. The safety catheter introducer of claim 20, wherein an upper edge of the wings in a folded state are substantially lower than an upper surface of the catheter hub.

22. The safety catheter introducer of claim 21 , wherein the distance between external lateral sides of the wings in the folded state approximately equals the diameter of a catheter luer-lock thread.

23. A catheter unit (23) comprising a catheter tube (24) and a catheter hub (25) affixed to a proximal end of the catheter tube and provided with an injection port (55) having an injection port operation end (56), having: a cover (58) closing the injection port operation end, wherein the cover includes a base part (59) and a cap (60) 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 (62) 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.

24. The catheter unit of claim 23, wherein the link includes a cap pivot.

25. The catheter unit of any of claims 23-24, wherein 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.

26. The catheter unit of any of claims 23-25, wherein the lower portion of the cover base part is 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.

27. The catheter unit of any of claims 23-26, wherein the cover, base part and cap are made of plastic and are integral.

28. A safety catheter introducer (20) comprising: a hollow elongated housing (21); a catheter subassembly movably disposed in the housing, wherein the catheter subassembly includes a catheter unit (23) having a catheter tube (24) and a catheter hub (25) affixed to a proximal end of the catheter tube and a needle unit (26) including a needle (27) having a needle distal sharp point and a needle proximal end to which a needle hub (29) with a flash chamber (30) 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 (58) closing the injection port operation end, wherein the cover includes a base part (59) and a cap (60) 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 and the catheter subassembly is operable in the housing for disposition in an idle position, a penetration position and a protection position.

29. The safety catheter introducer of claim 28, 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.