Intravenous catheter and insertion device with reduced blood spatter

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SPANISH OFFICE OF

PATENTS AND TRADEMARKS

SPAIN

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® Int. Cl .:

A61M 06/25

A61M 09/25

A61M 25/00

A61M 01/25

A61M 5/158 (2006.01) (2006.01) (2006.01) (2006.01) (2006.01)

TRANSLATION OF EUROPEAN PATENT

T3 @ Date of submission and number of the international application: 30.01.2012 PCT / US2012 / 023192 (87) Date and number of international publication: 09.08.2012 WO12106266 (96) Date of submission and number of the European application: 30.01.2012 E 12702739 (9) (97) Date and publication number of the European concession: 04.17.2019 EP 2670468 (54) Title: Intravenous catheter and insertion device with reduced blood splatter @ Priority:

31.01.2011 US 2011 61438197 P @ Date of publication and mention in BOPI of the patent translation:

30.10.2019 @ Holder / s:

VASCULAR PATHWAYS INC. (100.0%) 1916 Fallen Leaf Lane

Los Altos CA 94024, US @ Inventor / es:

BELSON, AMIR @ Agent / Representative:

VALLEJO LÓPEZ, Juan Pedro

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Notice: Within nine months from the date of publication in the European Patent Bulletin, of the mention of granting the European patent, any person may object to the European Patent Office to the granted patent. The opposition must be in writing and be motivated; It will only be considered as formulated once payment of the opposition fee has been made (art. 99.1 of the Convention on the Grant of European Patents).

ES 2 729 068 T3

DESCRIPTION

Intravenous catheter and insertion device with reduced blood splatters

Background of the invention

1. Field of the Invention

The present invention relates to devices for the insertion and placement of an access catheter in a vein or artery of a patient, on a guidewire.

The secure placement of an access catheter in the patient's vein or artery is particularly difficult in the case of small, tortuous, collapsed, fragile and / or difficult to locate vessels. The risk of accidental punctures and / or needle contamination after the placement of an intravenous catheter is particularly problematic. Therefore, it would be interesting to provide devices and methods that protect medical personnel from possible exposure to blood resulting from the retraction movement of the guidewire.

It is of particular interest for the present invention that access catheters are often pre-packaged with both a needle and a guide wire, where the needle is coaxially received on the guide wire and the catheter is coaxially received on the needle. The needle extends just beyond the distal tip of the catheter, so that the needle and catheter assembly can be inserted into the vein or other vessel. As soon as the entry into the vein is detected, usually by observing the blood return, the guide wire can be advanced into the venous light, the catheter advanced over the guide wire, and then the needle is removed from the catheter as the guide wire, leaving the catheter available for coupling to sources of fluids, medications or other intravenous materials.

The removal of the needle and the guide wire can be problematic, since they tend to carry blood from the patient and this results in the treatment staff being exposed to it. This can be particularly problematic in the case of guidewires having a helical tip or with another shape, such as those described in at least some of the United States patent applications published below.

For these reasons, it would be desirable to provide systems and methods for use with intravenous access catheters or other vascular access catheters, to reduce the risk of blood loss and spattering, where guide wires and / or needles are removed from the catheter. after placement. It would be particularly desirable if such methods and devices were compatible with venous catheters having automatic needle and guide wire retraction mechanisms, as described in the patent publications listed below. At least some of these objectives will be achieved by the invention as described herein.

two. Prior art

The object of the present invention is related to the following United States patent applications. Each of the various embodiments of an intravenous catheter insertion device described in said patent applications can be combined with the intravenous catheter of the present invention, to create an intravenous catheter system.

US 20100210934, “Intravenous catheter insertion and blood sample devices and method of use”

US 20100094310, “Intravenous catheter insertion device and method of use”

US 20080300574, “Intravenous catheter insertion device and method of use”

Also of interest are the following United States patents, which describe catheters having side arm connectors: 5,704,914; 5,154,703; 5,084,023; 4,585,440; 4,509,534; and 4,177,809.

Brief summary of the invention.

The invention is defined by the appended claims. The matter referred to as embodiments and / or inventions that are not claimed is not part of the invention.

The present invention provides venous access catheters and other vascular access catheters that are adapted to reduce blood loss and splatter, after removal of needles and guide wires used to insert the catheters. In particular, the present invention provides a catheter device, comprising; an outer shell; a tubular access needle fixed to a needle holder, wherein said needle holder is slidable with respect to said outer housing; a tubular catheter having a proximal attachment releasably fixed at a distal end of said outer shell, and coaxially positioned around said needle of

ES 2 729 068 T3 tubular access, comprising the proximal accessory: a first chamber; a second chamber arranged proximally to the first chamber; and an elastomeric membrane disposed between the first chamber and the second chamber, wherein the tubular access needle passes through the elastomeric membrane; a safety guide wire, sized and configured to advance through said tubular access needle; and an actuator mechanism, configured to selectively advance said safety guide wire through said tubular needle, in a distal direction, and then simultaneously remove said security guide wire and said tubular access needle in a proximal direction with with respect to said tubular catheter. The present invention provides a chamber and a membrane as a "cleaning" element. The actuator is further adapted to remove the needle and the guidewire, usually under the force of a spring or other deflection element, that quickly withdraws the needle and catheter into and from the cone. Generally, the guidewire will be a "safety" guidewire, with a helical shape or other preformed atraumatic shape at its distal end, which is adopted when the safety guidewire comes out from a distal tip of the needle, to reduce the risk of damaging the vessel as the guide wire is advanced. When the guide wire is removed, the safety tip straightens as it passes through the needle light, and inside the cone it takes up the helical configuration or other configuration, thus being able to release in the cone the blood that It may have picked up while it was in the artery or vein, rather than in the surrounding tissue or carcass. A lateral hole is provided in the cone, usually with a lateral tube, to introduce the desired fluids, in order to accommodate the septum or other cleaning element present at the proximal end of the cone.

Brief description of the drawings

FIG. 1 shows an exploded view of an intravenous catheter and an insertion device according to the present invention.

FIG. 2 shows an overall drawing of the intravenous catheter and the insertion device in an unfolded state, ready for use.

FIG. 3 shows an intravenous catheter and an insertion device in an unfolded state, ready for use.

FIG. 4 shows the intravenous catheter and insertion device of FIG. 3, with advanced guide wire.

FIG. 5 shows the intravenous catheter and insertion device of FIG. 3, with the guide wire and needle retracted.

FIG. 6 is an enlarged view of the intravenous catheter of FIG. 3.

FIG. 7 shows an embodiment of the intravenous catheter and the insertion device, with a separate side arm adapter.

FIG. 8 is an enlarged view of the side arm adapter of FIG. 7.

FIG. 9 is an enlarged view of the intravenous catheter according to the present invention.

FIGS. 10 and 11 illustrate another embodiment of a guidewire for use with the intravenous catheter and the insertion device.

FIG. 10 is a proximal end view of the guidewire, and FIG. 11 is a side view of the guide wire.

FIG. 12 illustrates an embodiment of an orientable guidewire, for use with the intravenous catheter and the insertion device.

Detailed description of the invention

FIG. 1 shows an exploded view of an embodiment of an intravenous catheter 100 and an insertion device 20 according to the present invention. FIG. 2 shows an assembly drawing of the intravenous catheter 100 and the insertion device 20 in an unfolded state, ready for use. In the following patent applications, additional intravenous catheter insertion devices that can be used in the present invention are described in detail: US 20100210934, US 20100094310 and US 20080300574.

The intravenous catheter insertion device 20 has a housing 21, which includes a proximal housing 1 that is adhesively attached or otherwise connected to a distal housing 11. In the example shown, the proximal housing 1 is in the form of a hollow cylinder elongate. The distal housing 11 is optionally formed with an ergonomic handle shape, designed to be held by the thumb and forefinger of a user. Other forms are also possible. The housing 21 has an elongated groove 22 extending from the proximal housing 1 to the distal housing 11, approximately parallel to a longitudinal axis of the housing 21. A wire feed slider 3 slides in a longitudinal direction along of an exterior of the proximal housing 1 and the distal housing 11, and has a tongue 23 extending through the groove 22 into the interior of the housing 21. A needle holder 6 can slide inside the housing 21 and is located distally to the tongue 23 of the wire feed slider 3. The distal end of the needle holder 6 includes a liner connector accessory 16, or the like. In the needle holder 6 there is a notch 24, proximally to the needle holder. A button 25 is located on one side of the distal housing 11, which has a tongue 26 that is configured to engage with the notch 24 in the needle holder 6 when the needle holder 6 is in its most distal position. A cylindrical stop 2 of guide wire is adhesively attached to the proximal end of the proximal housing 1.

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A stainless steel tubular hypodermic needle 7, with a bevel and sharp distal end 29, is bonded with adhesive 13 or otherwise attached to the distal end of the needle holder 6. Preferably, the needle 7 has one or more grooves 27 cut into the sides , which connect with the needle light for the passage of blood. A guidewire 9 is adhered with adhesive 14 or otherwise bonded to the tongue 23 of the wire feed slider 3. The guide wire 9 is preferably made of a highly elastic material, such as a super-elastic nickel-titanium alloy wire with a diameter of about 0.0762-0.3048 mm, and more preferably with a diameter of about 0.1016 mm The guide wire 9 may have a uniform diameter or said diameter may be staggered or narrowed, for example by grinding. For example, a wire of 0.20132 mm in diameter can be rectified without centers to create a distal portion of 0.20132 mm in diameter with a short conical transition. Optionally, a proximal portion of the guidewire 9 can be supported with a support tube 8 made of stainless steel or nickel titanium alloy hypodermic tube, or a molded or extruded polymer tube. Another option for constructing the guide wire 9 would be to join a short distal portion of a highly elastic material, such as a super-elastic nickel-titanium alloy wire, to a tubular, solid or larger diameter proximal portion, for example by welding, stamping, crimping and / or adhesive bonding. As best seen in FIG. 9, the distal end of the guidewire 9 is preformed into a spiral 28 tightly wound, with an outer diameter smaller than the inner diameter of the target vessel into which it will be inserted. The spiral tip 28 acts as a safety stop on the guidewire 9, to avoid puncturing or damaging the inside of the target vessels. The wound tip 28 of the guidewire is particularly useful for protecting fragile or delicate veins. Due to the extreme flexibility of the nickel-titanium alloy wire, the distal spiral curve 28 can be straightened when the guide wire 9 is dragged into the needle 7, and completely recovers its spiral configuration without plastic deformation when the lead is advanced. guide wire 9 out of the needle 7. In the example shown, the distal end of the guidewire 9 has a first loop with a small diameter of approximately 4.2418 mm, for approximately 0.75 revolutions and a second loop of greater diameter of approximately 4.445 mm, for approximately 1 revolution The first and second turns are preferably approximately coplanar to each other, and also preferably approximately coplanar with the straight proximal portion 12 of the guidewire 9. Other configurations of the guide wire 9 may include: multiplanar, individual coil, full radius at the end and / or a ball-shaped end with a diameter smaller than the diameter of the needle.

The guide wire 9 is positioned to move coaxially through the needle light 7. Optionally, a flexible tie 4 is connected from the tongue 23 of the wire feed slider 3 to the proximal end of the needle holder 6. Optionally, it can a needle holder cover 5 is provided to facilitate adhesive bonding of the fastener 4 to the proximal end of the needle holder 6. The length of the tie 4 prevents the guide wire 9 from being pulled too proximally with respect to the needle 7, because it would be difficult to reinsert the small diameter distal loop 28 at the proximal end of the needle 7 if it were removed completely from the needle light. In another option, instead of using a tie, a plastic protrusion or other physical structure, such as a barrier, it can act as a retainer to prevent the guidewire 9 from being pulled beyond the desired point. Optionally, the retainer can be configured so that it can be exceeded in case of forced retraction, such as that initiated by the spring 10, thus allowing complete retraction of the guide wire 9. In another option, the housing 21 may be configured so that the guide wire 9, or the structure that is connected to the guide wire 9, is at a firm stop, such as the guide wire stop 2 or the proximal end of the housing 21, before the guide wire 9 reaches a position too proximal with respect to the needle 6.

The proximal carcass 1, the distal carcass 11, the guide wire advance 3 slide, the button 25, the needle holder 6, the guide wire stop 2 and the needle holder cover 5 can be formed of any suitable material for its Use in medical applications. For example, some or all of these pieces can be molded and / or machined from a rigid and transparent medical grade plastic, such as acrylic or polycarbonate.

A compression spring 10 or a similar deflection element is located between the needle holder 6 and the distal end of the housing 21, to push the needle holder 6 in a proximal direction. The force of the spring 10 is resisted by the tongue 26 of the button 25, which engages the notch 24 of the needle holder 6 when the needle holder 6 is in its most distal position. It should be noted that in FIG. 1 the spring 10 is shown in a compressed condition state, as it would be in the intravenous catheter insertion device 20 assembled in an unfolded state.

The intravenous catheter 100, which in FIG. 6 is shown in an enlarged view, it has a catheter tube 102 with an inner light that coaxially fits around the needle 7 of the insertion device 20. The catheter tube 102 is preferably extruded from a flexible medical grade polymer, having a low coefficient of friction, for example PTFE, polypropylene or polyethylene. Preferably, the intravenous catheter tube 102 fits tightly with the needle 7 and a conical distal end, to minimize any passage between the needle 7 and the catheter tube 102 as they are inserted through the wall of a vein.

The proximal end of the catheter tube 102 is connected to a proximal fitting 104 that is connected to the distal end of a side-arm flexible tube 106, which extends laterally from the side of the proximal fitting 104. Preferably, the proximal fitting 104 is molded from a transparent polymer so that the withdrawal of blood from the needle 7 can be observed in the proximal accessory 104. A laser accessory 108 or the like

ES 2 729 068 T3 is fixed to the proximal end of the side arm tube 106. From the laser fitting 108 a fluid flow path is formed to the proximal fitting 104 and the catheter tube 102, through the side arm tube 106. Preferably, the fluid flow path is free of obstructions, sudden changes in diameter or dead spaces that could interfere with the fluid flow, or form nests for thrombus formation. Optionally, the intravenous catheter 100 may include wings 105, which facilitate adhesive bonding of the intravenous catheter 100 to the patient's skin after insertion. The wings 105 can be rigid or flexible and, optionally, can be integrally molded with the proximal accessory 104.

A hemostasis valve 110 is located on a proximal side of the proximal accessory 104. The hemostasis valve 110 is preferably configured as an elastomeric membrane 112, with a small hole 114 in the center thereof. The hole 114 forms a sliding seal around the needle 7 of the insertion device 20. Alternatively, the elastomeric membrane 112 may be intact, and the needle 7 will form a hole 114 when it is inserted through the membrane 112. The elastomeric membrane 112 may be composed of latex, silicone, polyurethane or other medical grade elastomer. Optionally, a small amount of medical grade lubricant, such as silicone oil, can be used to reduce the friction of the needle 7 passing through the hemostasis valve 110. Other hemostasis valve configurations known in the industry may also be used, such as those with different membrane configurations, holes, slits, or duckbill valves. Optionally, more than one or a combination of different hemostasis valves 110 may be used.

Optionally, a cleaning element 120 is located proximally with respect to the hemostasis valve 110. The cleaning element 120 is adapted to remove blood from the surface of the guide wire 9 and the needle 7 as they are removed from the catheter IV 100. The cleaning element 120 may be made of an absorbent or super absorbent material, to absorb blood from the surface of the needle 7 and the guide wire 9. Some examples of suitable materials include, without limitation, cotton, gauze, felt, natural or artificial sponges, open cell foams, etc. Alternatively, the cleaning element 120 can be configured as an elastomeric membrane that acts as a drainer to remove blood from the surface of the guide wire 9. The elastomeric membrane will preferably be elastic enough to adapt to the larger diameter of the needle 7, and then to the smaller diameter of the guide wire 9 when the needle 6 has been removed. Preferably, the cleaning element 120 is made with a hole or slit 122 in the center, which is aligned with the hole 114 of the hemostasis valve 110. Alternatively, the cleaning element 120 may be intact, and the needle 7 will form a hole 122 as it is inserted through the cleaning element 120.

Optionally, there may be a laser accessory 16 or the like in the proximal accessory 104 of the intravenous catheter 100, which fits over a sliding laser accessory 16 at the distal end of the needle holder with a slight interference fit, to hold the intravenous catheter 100 in place , as shown in FIGS. 1 and 2. Certain alternative configurations of the device may use a lighter block or other locking mechanism to temporarily connect the intravenous catheter 100 to the insertion device 20. Alternatively, the friction of the needle 7 passing through the hemostasis valve 110 and the element of Cleaning 120 may be sufficient to hold the intravenous catheter 100 in the insertion device 20.

An optional feature of intravenous catheter 100 of any of the examples described herein is a means 142 for selectively blocking or occluding fluid flow through side arm flexible tube 106. This may be in the form of a tube clamp or stopcock located on the side arm flexible tube 106 or on the light fitting 108, as shown in FIGS. 1 and 2. Alternatively, a separate stopcock can be connected to the laser accessory 108 to selectively block the flow of fluid.

FIGS. 3-5 illustrate steps of a method for inserting an intravenous catheter 100 using an intravenous catheter insertion device 20, such as those described above in relation to FIGS. 1, 2 and 6. The intravenous catheter 100 and the insertion device 20 are provided as a single-use, non-reusable device, supplied to the doctor or other sterile medical practitioner, in an unfolded state ready for use. use, as shown in FIG. 3. In another option, the device can be stored with the spiral distal portion 28 of the advanced guide wire 9 distally with respect to the tip of the needle 7, so that it does not straighten during storage. In this case, the operator will fully retract the guide wire 9 into the needle 7 before use. In use, the operator uses the housing 21 as a handle to manipulate the intravenous catheter 100 and the insertion device 20. With the device in the unfolded state, needle 7 is used to puncture a vein. When observing venous blood in the proximal accessory 104, the operator knows that the distal tip of the needle 7, together with the distal part of the catheter tube 102, is in the lumen of the vein. The operator can then advance the slider 3 in the distal direction to extend the guide wire 9 out of the needle 7, into the vein lumen, as shown in FIG. Four. The distal portion of the guide wire 9 adopts its spiral configuration 28 to act as a safety bumper, to prevent accidental puncture of the wall farthest from the vein or other damage to the vein, and also to allow passage to along obstructions such as valves or curves. Once the guidewire 9 is deployed in this manner, the operator can continue to advance the intravenous catheter 100 securely until it is sufficiently inserted into the vein, then the operator will press the button 25, which unhooks

EN 2 729 068 T3 the tongue 26 of the notch 24 of the needle holder 6. The spring 10 drives the needle holder 6 and the slider 3 in the proximal direction, thereby simultaneously dragging the needle 7 and the guide wire 9 into the housing 21 , leaving only the intravenous catheter 100 in the vein lumen. FIG. 5 shows the insertion device 20 with the needle 7 and the guide wire 9 removed inside the housing 21. Preferably, the loop 28 on the distal tip of the guidewire 9 is visible when the insertion device 20 is in the deployed position, as shown in FIG. 5. This allows the operator to verify that the guide wire 9 is intact and that only the intravenous catheter 100 has been left in the patient's vein.

While it is desirable that the insertion device 20 remove the needle 7 and the guide wire 9 simultaneously, the actuator mechanism could also be modified so that it removes the needle 7 and the guide wire 9 sequentially. For example, the drive mechanism could remove the needle 7 first and then, after a slight delay, remove the guide wire 9. Alternatively, the drive mechanism could be modified so that two separate movements of one actuating member or selective movements of two separate actuating members were necessary to remove the needle 7 and the guidewire 9 selectively. By way of another alternative, the spring 10 of the drive mechanism could be omitted, thus allowing the needle 7 and the guide wire 9 to be removed manually using the slider 3. Once the intravenous catheter 100 has been inserted into the patient's vein, the slider 3 is moved proximally along the groove 22 to remove the needle 7 the guide wire 9 into the housing 21.

FIG. 7 shows the intravenous catheter 100 and the insertion device 20 with a separate side arm adapter 130. FIG. 8 is an enlarged view of the side arm adapter 130 of FIG. 7. The structure of intravenous catheter 100 is similar to that described above in relation to FIG. 6, except that the proximal accessory 104 has a male laser connector 132 at its distal end, which is interconnected with a female laser connector 134 located on the proximal end of the catheter tube 102.

FIG. 9 is an enlarged view of intravenous catheter 100 in accordance with the present invention. The proximal accessory 104 and the lateral arm 106 may be integral with the intravenous catheter 100, as shown in FIG. 9, or they may be part of a separate side arm adapter, similar to that shown in FIGS. 7 and 8. In this embodiment, the proximal accessory 104 has a first chamber 136 in fluidic connection with the catheter tube 102, and a second chamber 138 separated from the first chamber 136 by the hemostasis valve 110. Optionally, a cleaning element 120 to remove the blood of the guide wire 9 is located on the proximal side of the second chamber 138. Preferably, the second chamber 138 is sized to allow the coiled tip 128 of the guidewire 9 to resume its coiled configuration after its removal through the hemostasis valve 110. Any possible dripping or splashing of blood from the guiding wire 9 is will produce in the second chamber 138. The optional cleaning element 120 will help remove the remaining blood from the guide wire 9 as it is removed from the second chamber 138.

FIGS. 10 and 11 illustrate another preferred embodiment of a guidewire 9 for use with the intravenous catheter 100 and the insertion device 20 of the present invention. FIG. 10 is a proximal end view of the guide wire 9, and FIG. 11 is a side view of the guide wire 9. The guide wire 9 is preferably made of a highly resilient material, such as a super-elastic nickel-titanium alloy wire with a uniform diameter of about 0.0762-0.3048 mm, most preferably about 0.1016 mm. The distal end of the guide wire 9 is preformed into a spiral 28 tightly wound, with an outer diameter smaller than the inner diameter of the target vessel into which it will be inserted. Due to the extreme flexibility of the nickel-titanium alloy wire, the distal spiral curve 28 can be straightened when the guide wire 9 is withdrawn into the needle 7, and fully recovered to the spiral configuration, without plastic deformation, when the guide wire 9 is advanced out of the needle 7. In the example shown, the spiral distal curve 28 of the guidewire 9 is in the form of a propeller with approximately three turns or rotations of substantially uniform diameter. In a particularly preferred embodiment, the helical turns of the spiral distal curve 28 have an outer diameter of approximately 1.3 mm. Alternatively, the spiral distal curve 28 may be in the form of a conical helix with turns that decrease or increase in diameter. In the example shown, the helical turns of the spiral distal curve 28 have a central axis perpendicular to, and offset with respect to, an axis defined by the proximal portion 12 of the guide wire 9. In other embodiments, the central axis of the distal spiral curve 28 may be skewed with respect to the axis of the proximal portion 12 of the guidewire 9. Other possible configurations of the spiral distal curve 28 are described in patent applications US 20100210934, US 20100094310 and US 20080300574.

The proximal portion 12 of the guidewire 9 is preferably supported with a support tube 8 made of stainless steel or nickel titanium alloy hypodermic tube or, alternatively, a molded or extruded tube made of a polymer, such as for example FEP , PEEK or HDPE. The support tube 8 will preferably have an inner diameter sufficient to insert the proximal portion 12 of the guide wire 9 therethrough, for example an inside diameter of 0.1524 mm to accommodate a guide wire 9 with a diameter of 0, 1016 mm The support tube 8 will preferably have an outside diameter of about 0.3048-0.4064 mm, most preferably about 0.3556 mm. Optionally, the support tube 8 can be adhesively attached or otherwise fixed to the proximal portion 12 of the guidewire 9,

ES 2 729 068 T3 the distal end of the support tube 8 being positioned at a short distance, proximally, with respect to the distal curve 28. The support tube 8 can have a narrowed distal end 144, which can be formed by a process of molding or by applying an adhesive fillet or other material during assembly.

FIG. 12 illustrates another embodiment of a guidewire 9 for use with the intravenous catheter 100 and the insertion device 20 of the present invention. The guidewire 9 can be manufactured from a wire of uniform diameter or a narrowed wire, and can optionally be supported by a support tube 8 as described above. The distal spiral curve 28 of the guidewire 9 can be any of the configurations described or incorporated herein. In the guidewire there is a curvature 140 10 of approximately 30 to 60 degrees, a short distance proximally speaking with respect to the spiral distal curve 28, for example 1 to 5 mm. The curvature 140 may be located just at the distal end 144 of the support tube 8 or, optionally, the curvature 140 may be located a short distance distally speaking with respect to the distal end 144 of the support tube 8, for example 1 to 5 mm The curvature 140 allows the guidewire 9 to be used in an airship manner, to facilitate the guidance of tortuous and / or branched blood vessels.

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