US20150352318A1 - Ultrasound assisted catheter placement system - Google Patents

Abstract

A deep vein intravenous introducer has a wheel located toward the front end of the device that can be rotated by the index finger of the user. After placement of the needle in the lumen of the vessel, the user rotates the wheel, which advances the wire guide through the center of the needle and into the patient. Once the guide wire is advanced into the vessel lumen the catheter can be advanced over the guide wire with a hub or finger tab on the catheter close to the index finger. The operation can be performed by one hand without moving the hand from its initial position. The user can then simultaneously use the other hand to operate an ultrasound detection device during insertion without the assistance of another person. A catheter is provided that can be visualized by ultrasound to enable confirmation of correct placement in a vessel. A probe cover is provided that is pre-sterilized and packaged in a cardboard with the top sides of the cover folded down over the cardboard. The cover is placed over the probe end, the sides of the cover are folded up, and the cardboard is removed. The sterile probe cover can be quickly and efficiently placed over the ultrasound's transducer end. Finally, a kit is provided that contains all of the medical devices needed to perform cannulation.

Description

RELATED APPLICATIONS
• This application claims the benefit of U.S. Provisional Application No. 61/770,052, filed Feb. 27, 2013, the entire contents of which are incorporated herein by reference.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• This invention relates to a system, device and method for the introduction of catheters and more particularly to the introduction of catheters into small diameter blood vessels, deep vessels, central veins, arteries, and those visualized by ultrasound.
• 2. Background of the Related Art
• Catheter introduction sets are generally known. For instance, U.S. Pat. No. 4,417,886 discloses a catheter introduction set having a needle, catheter, wire guide and wire guide feed device in which when the needle is positioned into a lumen of a blood vessel, a wire guide is first inserted into the vessel and the catheter is fed over the wire guide from the use of a radially extended handle into the lumen. This arrangement is similarly disclosed in U.S. Pat. No. 4,772,264 with the addition of a retaining finger for stabilization of the catheter on the skin.
• However, these catheter introduction sets require the user to use two hands to operate the device. One hand is needed to insert the needle and catheter, and a second hand to feed the guide wire. This means that one hand has to be taken off the ultrasound probe to feed the guide wire. Consequently, a single user cannot visualize the guide wire directly while threading the vessel, which increases the possibility of misplacement of the guide wire.
• Catheters, both central and peripheral, are not designed to be visualized under ultrasound and correct placement is essential for proper medication administration. A catheter can be placed into a vessel with an introducer needle with or without a guide wire. The guide wire and the introducer needle can be visualized under ultrasound, but the catheter itself cannot be visualized. Because the catheter cannot be visualized, sometimes catheters are placed incorrectly. Examples of incorrect catheter placement include: in an artery instead of a vein, in a vein instead of an artery, and in neither a vein nor an artery. Arteries flow next to veins and can be easily catheterized accidentally when aiming for a vein. Accidental placement of a catheter in an artery instead of a vein can lead to destruction of tissues receiving blood from that artery due to application of medications that damage arteries and are intended only for use in veins.
• While placing an ultrasound guided IV catheter there are two directional variables the health care professional has to deal with: longitudinal and vertical. Without the use of a directional marker the physician can become disoriented to the longitudinal direction. There is a simple method to alleviate this complication by using a directional marker to orient the longitudinal direction of the catheter to the vessel, eliminating this variable and simplifying the ultrasound guidance technique. Two temporary points can be marked on the surface of the skin one at the point of planned initial entry of the catheter over the vessel and another small distance distal to this point. The ultrasound can be used to follow the vessel allowing the clinician to mark these two points above the vessel on the skin. However, currently available catheter introduction sets do not incorporate a means to make directional markings on the skin.
• Stable position of the body part to be catheterized is essential for both placement of the catheter and comfort of the patient. Catheter introduction kits are available manufactured by Arrow International for the radial artery. These kits include a case that both holds the kit contents and provides means to stabilize the wrist for the catheter insertion in the artery of the wrist. Currently there are no kits available for catheter introduction in the anti-cubital veins of the upper arm. Because no such kits are available, practitioners do not have readily available means to stabilize the arm for catheterization. Likewise, additional body parts that are catheterized besides the arm, also do not have kits available that provide body part stabilizing means.
• Ultrasound guided vascular access and other procedures must be done in an expedited fashion for medical purposes. Often the speed of vascular access can be a matter of life or death. This procedure is invasive, meaning that there is the chance of bacteria being introduced from the skin into the vessel, which is why the procedure must be performed under sterile conditions. Ultrasound probes used repeatedly have a propensity to be contaminated. For this reason sterile probe covers are used to prevent infection. Current probe covers for probes used in ultrasound guided vascular access are large, bulky and time consuming to put on. These probe covers are very long in order to cover not only the transducer end of the probe, but also much of the cord.
• A fast time to catheter placement is essential in the health care setting for the administration of medications especially in sick patients, and patients in pain, who have rapidly spreading medical conditions. When placing an ultrasound guided IV having all the supplies in one place is essential for placement to be time efficient in the application of medicine or performing blood draws. However, the necessary equipment is often scattered throughout the department or not available in the department, making the procedure even more difficult or impossible to perform. Oftentimes medical professionals resort to using surgical rectal lubrication and attempt to use alcohol swabs on dirty ultrasound probes instead of a sterile sheath.
• Ultrasound guided catheters are more often in deeper vessels. This is because vessels closer to the surface are more easily visualized leading to greater success with the conventional technique. With the deep and small nature of the vessels used in the ultrasound guided IV catheter technique it can take more time and attention to place these catheters. More of the catheter is in the soft tissue between the skin surface and the deep vessel, which means that the deeper vessel has less of the catheter within its lumen. A slight slip of the catheter can cause displacement of the catheter from the lumen. In addition, sterile lubrication used for the ultrasound makes it difficult for tape and tegaderm to adhere to the skin. All of these factors make it difficult and essential to secure an ultrasound guided IV catheter.
• The placement of an ultrasound guided IV catheter is often painful to the patient. The use of an anesthetic at the skin surface can make catheter placement much more comfortable for the patient. The placing of a catheter via ultrasound usually uses a large bore catheter, 18 gauge or larger. The large gauge is necessary for the rapid transfusion of medicines, fluids and IV contrast, and this can be quite painful, especially because the placement of ultrasound guided IV catheters usually takes longer than the conventional method with a sharp needle being slowly manipulated beneath the skin. The use of local anesthetic at the site of entry can alleviate this pain.
• Ultrasound guided catheter introduction kits are currently available for central venous access, but no kits are available for ultrasound guided peripheral venous access.
SUMMARY OF THE INVENTION
• Accordingly, it is an object of the invention to provide a needle/catheter introduction apparatus that can be operated with one hand. It is a further object to provide an introduction apparatus that is reliable and easy to use. It is a further object of the invention to provide a catheter that can be visualized with ultrasound. It is yet another object of the invention to provide a probe cover that is easy to use, reliable, and sterile. It is still a further object of the invention to provide an assembly or kit with components needed for ultrasound guided catheter introduction to peripheral veins or arteries.
• A needle/catheter introducer is provided that can be operated by one hand. The introducer has a wheel located toward the front end of the device that is rotated by the index finger of the user. After placement of the needle in the lumen of the vessel, the user rotates the wheel, which advances the wire guide through the center of the needle and into the patient. Once the guide wire is advanced into the vessel lumen the catheter can be advanced over the guide wire with a hub or finger tab on the catheter close to the index finger. The introducer fits in the palm of the user's hand and the wheel can be operated by the user's index finger. Because the actions needed to advance the guide wire and advance the catheter can both be comfortably performed by one hand without moving the hand from its initial position, the catheter introducer is easy to use and allows the user to also operate an ultrasound detection device during insertion without the assistance of another person.
• In addition, a catheter is provided that is comprised of materials that make the catheter capable of being visualized by ultrasound to enable confirmation of correct placement in a vessel.
• In addition, a probe cover is provided that is pre-sterilized and packaged in a cardboard with the top sides of the cover folded down over the cardboard. The cover is placed over the probe end, the sides of the cover are folded up, and the cardboard is removed. The sterile probe cover can be quickly and efficiently placed over the ultrasound's transducer end.
• Still further, the invention includes a kit having components needed for ultrasound guided catheter introduction to peripheral veins or arteries. The kit has a sterile package with an ergonomic shape that can be used to stabilize the arm. The needle cover, in addition to protecting the needle, has a tip which can mark the skin to provide a directional marker. This allows the needle to be aligned to the direction of the vessel. The catheter introduction set allows a catheter tube to be introduced into blood vessels such as veins and arteries while keeping the ultrasound probe cover sterile. The introducer assembly is contained in a sterile package, which is designed to be converted into an ergonomic arm stand for assisting in stabilizing the arm while placing the catheter. The sterile package can also contain the sterile probe cover. The introducer assembly is removed as an entire unit including needle, catheter, wire guide, rotational wire guide feed device, needle cover with directional guide. The sterile probe cover is placed on the transducer end of the ultrasound probe. Other items in the kit that one might need to locate separately (outside of peripheral kits) to perform ultrasound guided catheter insertion on peripheral veins or arteries include: lidocaine or other anesthetic, sterile gel (for ultrasound transduction), ultrasound probe cover for sterile patient contact, two rubber hands to secure the ultrasound probe cover, suture material to stabilize the catheter on the arm.
• These and other objects of the invention, as well as many of the intended advantages thereof, will become more readily apparent when reference is made to the following description, taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE FIGURES
• FIG. 1 is a perspective view of the introducer in accordance with the preferred embodiment of the invention;
• FIG. 2 is a side cross-sectional view of the introducer ofFIG. 1;
• FIG. 3 is an exploded view of the wheel apparatus ofFIG. 2;
• FIG. 4 is a side view of the wire connector used to couple the drive wire to the guide wire inFIG. 1;
• FIG. 5 is a side cross-sectional view of the introducer just prior to a needle being placed on the introducer;
• FIG. 6 is a side cross-sectional view of the introducer coupled with the needle;
• FIG. 7 is a side cross-sectional view of the introducer with the guide wire extended;
• FIG. 8 shows the huh extended forward on the guide wire;
• FIG. 9 shows the huh and catheter that remains in a patient's body following removal of the introducer and introducer needle;
• FIG. 10A is an alternative embodiment of the introducer;
• FIG. 10B is a perspective view of the wheel assembly in accordance with an alternative embodiment of the invention;
• FIG. 11A is a perspective view of the introducer device having needle handles and hub handles with the two-wheel assembly ofFIG. 10B;
• FIG. 11B is a perspective view of the introducer device ofFIG. 11A having a needle cover;
• FIG. 11C is a detailed view of the needle cover tip having projections;
• FIG. 12 is a graph showing UV detectable materials;
• FIG. 13 is a perspective view of a probe cover assembly prior to being applied to a probe in accordance with another embodiment of the invention;
• FIG. 14 shows the cover assembly ofFIG. 13 fitted to a probe;
• FIG. 15 shows the container removed from the cover with the probe ready to be used;
• FIG. 16 shows a UV assisted introducer kit in accordance with another embodiment of the invention;
• FIG. 17 is a bottom view of the kit ofFIG. 16; and
• FIG. 18 shows the patient resting an arm on the kit ofFIG. 16.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• In describing a preferred embodiment of the invention illustrated in the drawings, specific terminology will be resorted to for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents that operate in similar manner to accomplish a similar purpose. Several preferred embodiments of the invention are described for illustrative purposes, it being understood that the invention may be embodied in other forms not specifically shown in the drawings.
• This catheter has several features which will improve medical treatment. With these added features, the catheter makes IV placement with ultrasound easier, more efficient, and more accurate, thus significantly decreasing pain experienced by the patient by reducing the number of IV sticks currently performed.
• As shown in the drawings the invention comprises of multiple elements that have separate novel advantages and features, but also can be utilized together to improve medical treatment by making IV placement with ultrasound easier, more efficient and more accurate, and reducing pain. Those elements include a catheter introduction apparatus (FIGS. 1-11B), a UV-visible catheter (FIG. 12), a needle cover with marking means (FIG. 11A-11C), a probe cover (FIGS. 13-15), a sterile kit package (FIGS. 16-18), and a catheter having finger tabs (FIGS. 11A,11B).
The Introducer Apparatus10 (FIGS. 1-11)
• Turning toFIGS. 1-10, an illustrative non-limiting embodiment of theintroducer apparatus10 is shown. As best shown inFIG. 2, theintroducer10 has ahousing100,wheel assembly130,drive wire12, and guidewire14. Thehousing100 is slightly elongated an ergonomically shaped to fit in the palm of a user's hand. The inside of thehousing100 is hollow, such that thehousing100 forms awall104. Thehousing100 has afront end108 and arear end106. Anopening102 is provided at therear end106.
• Anelongated coupling114 extends forward from the distalfront end108 of thehousing100. Thecoupling114 has the shape of an elongated post having a round cross-section. Thecoupling114 has a central opening. At the front of thecoupling114, the central opening is sized to be slightly larger than theguide wire14. At the middle of the coupling, the opening gets progressively larger to the rear end of thecoupling114. The tapered opening forms guidewalls116 that funnel the guide wire toward the smaller portion of the opening so that theguide wire14 can be pushed through thecoupling114 and out of thecoupling114 without stubbing or damage.
• Aguide post110 is also provided at thefront end108 of thehousing100. Theguide post110 extends forward from thefront end108. Thepost110 is elongated, has a square-shaped cross-section (though any suitable shape can be utilized), and extends substantially parallel to and slightly spaced apart from thecoupling114. Thepost110 is shorter than thecoupling114, but creates achannel112 between thepost110 and thecoupling114. An injection needle can then be received over thecoupling14 and is further secured in thechannel110 by thepost110. There can be asingle post110 positioned above the coupling114 (FIG. 2) or two posts on opposite sides of the coupling114 (FIG. 1), or both asingle post110 above the coupling and two posts on opposite sides of the coupling. It will be apparent that any number ofposts110 can be provided and positioned anywhere about thecoupling114 to reliably receive and retain the injection needle. In addition, other coupling means can be provided to reliably couple the needle to thehousing100.
• As best shown inFIG. 1, thewheel assembly130 is provided in anopening103 located at the top of thehousing100 at thefront end108. As more fully shown inFIG. 3, thewheel assembly130 includes awheel132 withteeth134 that extend transversely along the outer circumferential edge of thewheel132. Theteeth134 enable the user to more easily turn thewheel132. A small circular post or drum136 is provided on one side of thewheel132. Thecircular drum136 projects outward from the side of thewheel132 and is concentrically aligned with thewheel132. A through-hole138 extends transversely through the center of thedrum136 and thewheel132. Apin140 extends through the through-hole138 and engages openings in the two opposing sides101 (FIG. 1) of thehousing100 so that thewheel132 can rotate about thepin130. Thedrum136 is fixed to thewheel132 so that thedrum136 rotates as thewheel132 rotates.
• Returning toFIG. 2, one end of thedrive wire12 is partly wrapped about thedrum136. For instance, the distal end of thedrive wire12 can be at least partially placed in a hole137 (FIG. 3) that extends at least part way through thedrum136 to hold thedrive wire12 in place on thedrum136. Other suitable coupling methods can be used, such as adhesive, or a fastener. Thus, the user can wind thedrive wire12 to retract thedrive wire12. Thedrive wire12 is sufficiently rigid to retain a straight form, but sufficiently flexible to wind about thedrum136 of thewheel132.
• Still referring toFIG. 2, alock assembly150 is located just behind thewheel assembly130 on thehousing100. Thelock assembly150 includes alocking tab152,cover156,nut162,bolt164, anddisplay area158 that can be used to present a logo or directions to the user. Thebolt164 extends through an opening in thehousing100 and an opening in thelocking tab152. Thehead160 of thebolt164 is outside of thehousing100 and thebolt164 attaches to anut162 located on the opposite side of thelocking tab152. Thebolt164 fastens thetab152 in place on thehousing100 to engage theteeth134 of thewheel132. Thelocking tab152 is a flat element that extends to theteeth134 on thewheel132. Thetab152 can be somewhat flexible, so that the user can operate thewheel132. However, thetab152 prevents thewheel132 from moving when not be operated on by the user, and in particular prevents thewheel132 from moving backwards to retract thedrive wire14. Thetab152 can also make a clicking noise as thewheel132 is being moved forward, to provide an audible and/or tactile feedback that confirms to the user that thewheel132 is being moved. Though a bolt andtab152 are shown, it will be readily apparent that other mechanisms can be provided to prevent unintended operation of thewheel132. For instance, thewheel132 can be friction fit into theopening103 so that a slight force is needed to move thewheel132. Thecover156 extends over thebolt head160 so that the user does not get injured by thebolt head160. Thecover156 can be adhered or fastened to thehousing100.
• A connector or plug170 is provided at the distal ends of thedrive wire12 and theguide wire14. As best shown inFIG. 4, theconnector170 is configured to engage both thedrive wire12 and theguide wire14 so that theguide wire14 moves when thedrive wire14 moves. Theconnector170 has aconnector body171 that includes afirst opening172 that receives thedrive wire12 by a friction fit. Thebody171 also has apost174 that extends forward and has an opening that receives theguide wire14 by a friction fit. In addition, thebody171 includes a guide post or guidetab176 that extends forward substantially parallel to thedrive wire12. A small channel is formed between thetab176 and thedrive wire12 to receive and engage a tube or sheath15 (FIG. 1) that surrounds the twowires12,14 to prevent injury to the user or patient. A slit extends the entire longitudinal length of thesheath15, and theguide post176 moves through the slit. This keeps thedrive wire12 and theguide wire14 properly oriented with respect to each other during operation and so they do not become twisted. Instead of asheath15, thehousing100 can be extended to cover the twowires12,14.
• Operation of theintroducer10 will now be discussed with respect toFIGS. 5-9. In these illustrative non-limiting embodiments, theintroducer10 is coupled with a conventionalintroducer needle assembly200 having a standard catheter. One example of a suitable needle assembly is offered by Smiths-Medical, JELCO® I.V. Catheter, http://www.smiths-medical.com/catalog/peripheral-catheters/conventional-catheters/jelco-conventional-catheters/jelco-v-catheter-radiopaque.html. It will be recognized however, that theintroducer10 can be used with other suitable devices, such as Insyte™ Autoguard™ Shielded IV Catheters by Becton Dickinson (http://www.medline.com/product/Insyte153-Autoguard153-Shielded-IV-Catheters-by-Becton-Dickinson/IV-Catheters/Z05-PF29088#.UwqiYfldWo0), Introcan Safety® IV Catheter Straight by B Braun (http://www.medline.com/product/Introcan-Safety-IV-Catheter-Straight-by-B-Braun/IV-Catheters/Z05-PF70731#. UwqiufldWo0), IV Catheters by Exel International (http://www.medline.com/product/IV-Catheters-by-Exel-International/IV-Catheters/Z05-PF29139#.Uwqi-vldWo0), and OPTIVA® IV Catheters by Smiths Medical (http://www.medline.com/product/OPTIVA-IV-Catheters-by-Smiths-Medical/IV-Catheters/Z05-PF52843#.UwqjavldWo0).
• As shown inFIG. 5, theneedle assembly200 has a roundtubular housing204,needle202,hub206 andsupport member208. Thehousing204 has a first end that is open and mates with thecoupling member114. Thesupport member208 is fitted at an opposite end of theneedle housing204 and thehub206 is placed about thesupport member208. Theneedle202 extends through openings in thehub206 andsupport member208 and partly into the front end of the interior of thehousing204. Thecoupling114 of theintroducer assembly10 aligns theguide wire14 with theneedle202 of theneedle assembly200. Acatheter300 extends over the outside of theneedle202 and terminates at and couples with the huh206.
• The operation starts withFIG. 5, where aneedle assembly200 is aligned with theintroducer10. Thedrive wire12 andguide wire14 are fully retracted at the rear of theintroducer10. Turning now toFIG. 6, the user places theneedle assembly200 on theintroducer10. Thetubular housing204 of theneedle assembly200 is slidably received over thecoupling114 of theintroducer10. Thehousing204 wall enters the channel(s)112 between the one or more post(s)110 and thecoupling114. Theneedle housing204 fits snugly about thecoupling114, so that theneedle assembly200 does not come free of theintroducer10 until operated on by the user. As shown, theguide wire14 is aligned with theneedle202. It will be appreciated that though this is described as a manual process, theintroducer10 can come pre-loaded with aneedle assembly200 already positioned on theintroducer10. Or theintroducer10 can have a needle integrally formed with theintroducer10.
• At this point the user places theneedle202 into the patient, such as the vein or artery lumen. To do so, the needle cover250 (14G.11B) is first taken off of the needle and the needle cover tip252 (FIGS. 11B,11C) is used to mark the skin surface either with pressure or a marking ink in two spots to give directional marking for the direction of the cannulation. Theneedle cover tip252 has one ormore projections254 that extend forward from the front surface of thetip252. Theprojections254 shown are concentric curves that form a company logo. However, the projection(s)254 can have any shape, such as an arrow, line, or dot. Ink can be placed on theprojections254 and applied to the patient. Or, theprojections254 can be pushed into the patient's skin without ink, to cause pressure indentations on the patient. The user can use the inked cap to place directional markings on the patient. Without this it can be difficult to place cannula once it has entered under the skin. This can be especially useful with ultrasound guidance. Both marks are made at points along the vessel. The cannula (also called a catheter)300 is placed in the direction of this guidance in line with the vessel and theneedle202 is inserted into the patient. For deep vessels and small vessels the directional marking is of particular advantage. To visualize smaller vessels ultrasound can be used. As further shown inFIG. 11B, theneedle cover250 has a main tube that extends the length of theneedle202, and one ormore arms256 at the rear end that extend outward and upward over the top of thehub206. Thearms256 protect thehub206 and make it easy for the user to remove thecover250. Thecover250 can come pre-assembled over theneedle202, and protects the user from being injured by theneedle202.
• Returning toFIG. 6, after theneedle cover250 is removed, the needle is aligned along the skin with the two points marked for direction and then inserted into the lumen of the vessel. Once theneedle202 is proper placed, the user turns thewheel132 forward with an index finger in the direction X. This operation can be done using a single hand of the user. Since theneedle202 is already positioned in the vein, the user simply rotates thewheel132, which is easy to reach because it is at thefront end108 of thehousing body100. Thus, the user can retain hold of thehousing100 in the palm of the hand and (without moving his hand) operate thewheel132 with the index finger. In addition, the user holds theintroducer10 steady (i.e., it does not have to be moved forward) and allows the movement of thewheel132 to advance theguide wire12, so that single-handed operation is possible. Single-handed operation is further made possible by the contour shape of the hub. Thus, the user can hold an ultrasound probe in the other hand to assist placement of theguide wire12 andcatheter300. Thetab152 prevents thewheel132 from moving in reverse.
• As thewheel132 is moved forward, it draws thedrive wire12 further onto and around thewheel drum136. This, in turn, causes theconnector170 to push theguide wire14 forward (to the left in the embodiment ofFIG. 7). Theguide wire14 enters the central opening in theneedle202 and continues through theneedle202 until it emerges from the distal tip of theneedle202 and enters the patient, as shown inFIG. 7. Accordingly, theguide wire14 threads the vessel lumen.
• Thethin guide wire14 is then ready to have the softplastic catheter300 slid over theguide wire14 into the vessel lumen. As shown inFIG. 8, once theguide wire14 has entered the user's vein (which is roughly one to two and a half inches depending on catheter length), the user pushes the hub206 (or finger tabs on thecatheter300, if used) forward to force the catheter off theneedle202 and into the patient. Thesupport208 keeps theneedle202 positioned on theintroducer10. Thecatheter300 can be pushed into the patient further than theneedle202 and/or guidewire12 since it is more flexible and won't puncture the side of the vein or vessel. The user can then remove theneedle202 and guidewire12 from the patient, leaving the catheter and huh206 properly placed in the patient, as shown inFIG. 9. The user can then connect a syringe, intra venous (IV) device or other medical instrument at the rear end of thehub206.
• Turning toFIG. 10A, an alternative embodiment of the invention is shown. Here, theneedle202 is an elongated shank portion having a beveled tip. The shank is hollow or canullated and is joined at its rear or end to a hollowtransparent hub2 having a rounded front end. Thecatheter300 is sized to be telescopically fitted over the shank of theneedle202. As withFIGS. 1-9, thecatheter300 is slightly shorter than theneedle202 so that when it is fully pushed back against theneedle hub2 thebeveled tip5 of the needle projects outwardly from thecatheter tip4 by an amount sufficient to permit puncture of the blood vessel by the user of the device. A female luer-type fitting9 is formed on the rear of the catheter and mates with and fits over ashoulder projection11 on the front of thehub2. Thewire guide assembly3 includes anelongated tubular member19 which is fitted into the counter bore at the end ofhub2. Thetubular member19 can be formed of a transparent, semi-rigid plastic material, and have sufficient resilience to maintains its tubular configuration and use. Aguidance tab16 interfaces with the hollow,grooved tube19. Thetab16 is attached to the hack of the guide wire, and slides through the groove, making sure that the wire does not tangle or twist. Theshoulder projection11 is a solid plastic piece that is part of the housing and holds the wheel. Aflash guard13 keeps blood from spilling or squirting out the back end of the device. Asafety cap18 is also provided that can be removed when the device is used.
• In its preferred form, thetubular member19 has a longitudinally extending slot running from a point adjacent theneedle hub2. A plug or other suitable sealing means provides a seal for the end. An elongated flexible spring wire guide is housed withintubular member19. A wheel is provided that directly acts on the spring wire guide to advance the spring wire guide. This can be done, for instance, by a drum or shaft that is attached to the wheel. The outer surface of the drum can press the guide wire between a fixed surface on the housing to physically move the guide wire forward by friction. The drum can have a surface that grabs the guide wire.
• A laterally or radially extendinghandle7 is fastened to its rear end handle projects through the slot and is adapted to advance the spring wire guide through the lumen through needle and outwardly from the distal end into and through the lumen of the blood vessel. For facilitating this insertion with the use of one hand the index finger pushes one of the finger tabs on either side of thecannula4. Once in place thecannula4 can be secured with the securing tabs. The securing tabs can be secured to the skin, either with an adhesive tape or sutured into place through the holes in these labs.
• Thetabs210 are best shown inFIG. 11A. Theneedle202 is connected to ahub206 having a rounded front end. Handles ortabs212 are connected to the catheter, and handles ortabs210 are connected to thehuh206. The catheter handles212 and the hub handles210 are elongated and rectangular, and extend outward substantially transverse to thecatheter300 andhub206, respectively. The user can grab thetabs202 to push thecatheter300 forward. And the user can grab thetabs210 to push thehub206 forward. Thus, thehub206 has elongated slots to receive the hub handles210. The catheter handles212 and the hub handles210 are easier for the user to grab and operate.
• As further shown inFIG. 11A, aflash chamber214 can be provided behind thehub206. Theflash chamber214 allows the user to see blood and fluid. Once the vessel is pierced by theneedle202, blood enters theflash chamber214. Theflash chamber214 is transparent, so that the user can visually confirm that the vessel has been pierced but to keep the blood from getting on the practitioner, patient or device. Thechamber214 has atab216 that can connect to a safety cap. In the present embodiment, theneedle202 is connected to theflash chamber214, but theflash chamber214 is not connected with the huh206. Thecatheter300 is connected to thehub206.
• Turning toFIG. 10B, an alternative embodiment of the wheel assembly ofFIGS. 1-9 is shown. Here, thewheel assembly230 has twowheels232 separated from each other by aslight gap233. Thewheels232 have an outer circumferential edge that can have transverse ridges, a roughened surface or an easy to grip surface (such as rubber), to make it easy for the user to operate thewheels232. Acircular drum234 is affixed to or integral with the side of one of thewheels232. Thedrum234 has an outer circumferential edge with large transverse ridges orteeth236 positioned thereabout. A lockingstructure238 is coupled to thehousing100 of theintroducer10 and aligned with thedrum234. The lockingstructure238 has a top inner surface that is aligned with thedrum234, and can optionally include at least one mating tooth that engages thedrum teeth236. Thedrum teeth236 are configured so that thewheel232 can advance theguide wire14 into the patient, but that thewheel232 cannot be reversed. The inner surface of the lockingstructure238 can also rub against the surface of theteeth236 so that thewheel232 does not move without being operated on by the user. Apin240 extends through the center of thewheels232 and drum234 to permit thewheels232 and pin240 to rotate with respect to thehousing100. Thedrive wire12 extends into thegap233 between thewheels232 and the end of thedrive wire12 is wrapped about thepin240. Thus, as the user operates thewheels232, thedrive wire12 wraps around thepin240 and advances theguide wire14 into the patient. Thepin240 can optionally have a widened portion at thegap233 to receive thedrive wire12. Or, the twowheels232 can be connected together as a single wheel that has a channel which receives thedrive wire12, and thepin240 need not move. It will be apparent that other suitable configurations can be provided within the spirit and scope of the invention.
• Usually thewire guide12 only needs to be fed forward, so the default state of the wire guide feed wheel assembly prevents backward feeding. To prevent backward feeding, the tab152 (FIG. 2) or gear box238 (FIG. 10B) unidirectional block movement of thedrum teeth236. In order to allow backward feeding of the wire guide, a user can unscrew the bolt164 (FIG. 2) or push down on the wheels232 (FIG. 10B) and rotate thewheels232 in the direction opposite of that for forward feeding. Pushing down on thewheels232 moves thedrum234 away from thegear box238, enabling backward rotation. Aspring23 can maintain thedrum teeth236 in contact with the gear box teeth in the default setting.
• Theentire introducer10 can be made of a plastic medical grade polymers and UV cure adhesives), except that thetab152,bolt164,nut162,drive wire12 andguide wire14 are preferably made of metal (such as stainless steel, 300 series). The entire introducer can be sterilized and packaged in a sterilized container, such as being heat sealed in a plastic bag. A typical material for the catheter is Tecollex EG-80A polyurethane. Component materials are usually a polycarbonate like Lexan HP4 or an ABS like Cycolac HMG47MD.
• In a non-limiting illustrative embodiment of the invention, thecoupling element114 is about lcm long with a diameter of about 4 mm. Theintroducer10 is about 6.2 cm long (including the coupling element114), and has a width of about 3.8 mm. Thewheel132 has a diameter of about 1.4 cm. Thedrive wire12 has a length of about 20-29 cm, and theguide wire14 has a length of about 18-27 cm so that theguide wire14 can be advanced through the longest needle that is used. Thecoupling114 can be sized to fit any needle, and theguide wire14 can be sized to any size needle. Common site needles are 16-18 gauge, but larger gauges such as 14-15 would be suitable, and still larger or smaller needles may be suitable as well.
• The Ultrasound-Guided IV Catheter has a number of features that make placement of the catheter in deep peripheral vessels easier. First, it has an inked cap that permits the user to mark the location and direction of the vessel as visualized by the ultrasound machine. This gives directional guidance to the catheter along the vessel for insertion. The cap can mark the skin for directional guidance. When placing an ultrasound guided IV catheter the medical professional placing that catheter can get lost as to the direction of the needle in relationship to the vessel. The Ultrasound gives a two dimensional image which does not show direction. The cap on the ultrasound guided IV marks the surface of the skin so the direction of the vessel can be marked on the skin. For instance, the marking can have an ink spot or directional arrow indention into the skin, allowing the catheter to be aligned to the vessel. The medical professional can then align the needle/catheter which the markings and not miss the vessel.
• Second, the catheter has a slender guide-wire that can easily thread smaller, deeper vessels. The guide-wire can easily thread deep vessels and advance the catheter without catching on the vessel walls. The ultrasound is used to find deeper vessels which cannot be visualized by the human eye. These deep vessels are difficult to thread with the soft large plastic catheters. The catheter can catch on the sides of the vessel and thus not slide easily into the lumen of the vessel. The Ultrasound guided IV catheter uses a thin guide wire to thread deep vessels. The guide-wire is placed within the lumen of the vessel first and then the catheter is threaded over the catheter, preventing the catheter from getting caught on the sides of the vessel wall.
• The guide-wire and catheter can be advanced and placed with only one hand so that as one holds the catheter with one hand the other hand holds the ultrasound and visualizes correct entry into the vessel. The drive wheel advances theguide wire14, and the catheter tabs or huh advance catheter over the guide-wire. The other hand is free to manipulate the ultrasound. When moving the guide-wire into the vessel a traditional catheter needs two hands for guide-wire placement: one hand placing the catheter and the other hand advancing the guide wire. The Ultrasound guided IV catheter advances the guide-wire and catheter with the same hand. This gives a unique advantage to ultrasound guidance because one person can use his spare hand to hold the ultrasound to visualize the guide-wire and catheter being advance ensuring placement in the vessel lumen.
• The present introducer avoids potential complications with exposure to blood and fluid, and provides a tactile resistance. The drive wire also provides a spring-like behavior when wound about the wheel assembly to provide greater control of the advancement and retraction of the drive wire. However, it will be apparent that other configurations of the introducer may be possible within the spirit and scope of the invention. For instance, the drive wire can be eliminated and the guide wire directly connected to the wheel assembly to push the guide wire.
The Visible Catheter300 (FIGS. 11-12)
• Another object of the invention is to provide a catheter, both central and peripheral, that can be visualized by ultrasound, to enable correct placement to be determined and recorded by ultrasound visualization. Catheters, both central and peripheral, which are easily visualized by ultrasound, enable correct placement to be determined and recorded by ultrasound visualization.
• It is noted that current catheter materials cannot be detected by ultrasound. In the present embodiment of the invention, thecatheter300 is constructed of materials that can be easily visualized under ultrasound. For instance metals, ceramics, or compounds (like barium sulfate or titanium), can be integrated within the stricture of the catheter material allowing for direct visualization of catheter placement with the ultrasound. As an example, one could confirm by ultrasound that a catheter intended to be placed in a vein is in fact located in a vein and not in an artery or outside any blood vessel.
• Ultrasound properties are material dependent. The sound velocities and impedance values of typical catheter materials such as plastics, urethanes or rubbers are very low (0.959-2.06 km/s and 1.41-2.00 MRayl) compared to metals such as, aluminum, copper and Titanium (5.01-6.3 km/s and 17.0-44.6 Mrayl). The properties for low density polyethylene and Titanium are compared inFIG. 12. This demonstrates that as the density of a material changes, so do it's acoustic properties. Materials of different densities will appear as distinct and different in an ultrasound image.
• In yet another embodiment of the invention, the outer surface304 of the catheter is coated with metallic material such as Titanium, the catheter. This makes thecatheter300 detectable by ultrasound, because the high impedance surface will reflect some of the sound. A specific length of the catheter to be detected by ultrasound is coated with a metallic coating, such as by using sputtering. Thus, only a portion (the front end) of thecatheter300 can be coated or made of UV visible materials. Sputtering is a Physical Vapor Deposition vacuum process used to deposit very thin films onto a substrate for a wide variety of commercial and scientific purposes. Sputtering occurs when an ionized gas molecule is used to displace atoms of a specific material. These atoms then bond at the atomic level to a substrate and create a thin film. Several types of sputtering can be used, including: ion beam, diode, and magnetron sputtering. Sputtering units are available commercially and not only they can help in coating a variety of metallic materials, but the thickness of the coating can also be measured during the sputtering process. The coating thickness is typically in Angstroms. Preferably, Titanium is used best mode, because of its biocompatibility and excellent corrosion resistance to a broad range of possible corroding media that may be encountered in the field of medicine.
• It is noted that thecatheter300 and the introducer10 (FIGS. 1-10) of the invention have separate utility and need not be utilized together. For instance, thecatheter300 can be utilized with any catheter introduction set, and not only theintroducer10 of the present invention. In addition, theintroducer10 can be used to place any conventional catheter, and need not be utilized with thecatheter300 of the present invention. Not withstanding those separate uses, thecatheter300 andintroducer10 of the invention have certain advantages when utilized together (FIGS. 1-10). Because thecatheter300 is visible to UV detection and theintroducer10 allows the user to perform IV insertion with a single hand, the user can perform UV detection at the same time he/she is inserting an IV into the patient. Thus, the user can confirm proper placement of theneedle202, as well as thecatheter300, during and immediately after insertion. The user can perform thecatheter300 placement with a single hand using theintroducer10, and with the other hand can track placement of theneedle202 and thecatheter300 in the patient.
Probe Cover400
• Another embodiment of the invention is shown inFIGS. 13-15. A sterile cover set400 is provided that can be placed over the transducer end of a piece of medical equipment, such as anultrasound probe402. The sterile probe cover set400 includes asterile probe cover404 and acontainer410. Thecover404 is open at the top (i.e., no lid or cover) and can be made of rubber or latex for instance, can have the general shape of theprobe402 and is sized to fit snugly over theprobe402. In the embodiment shown, thecover404 is shaped like a hag, with a bottom and sides and can optionally match the shape of theprobe end401. Thecontainer410 can have a similar shape as thecover404 and is slightly wider than thecover404. Thecontainer410 is shorter than thecover404 so that thetops406 of the sides extend beyond the top of the sides of thecontainer410. In the current embodiment, thecontainer410 can be a circular piece, with a bottom and sides, or can be a tube with no bottom, or can have a rectangular shape. Thecontainer410 can optionally match the shape of theprobe end401. Thecontainer410 can be made of cardboard or from hard plastic or other material which can maintain its shape and the shape of the rubbersterile probe cover404. Thecontainer410 is wider than the probe and thecover404, so that thecover404 is stretched and can be easily fit over theend401 of theprobe402.
• Thecover404 is pre-assembled to be inside thecontainer410, and thetop sides406 of thecover404 are stretched and folded down over the top sides of thecontainer410. Thecontainer410 and cover404 are packaged in a sealed plastic bag, and the entire packaging is sterilized.
• When theprobe402 is ready to be used, the user opens the sealed plastic bag and removes thecontainer410 with thecover404 positioned inside of thecontainer410. The user should preferably hold the assembly by thecontainer410. However, only the inside of thecover404 is exposed (since the cover is turned inside-out at the top sides406), so the user can touch thecover404 without contaminating the outside of thecover404.
• As shown inFIG. 13, the user then pushes thecontainer410 and cover404 over the end of theprobe402, so that thesterile probe cover404 is wrapped around theprobe402. Optionally, ultrasound gel can be placed on the surface of the sterile probe cover prior to placing it on the ultrasound probe. Referring toFIG. 14, thecover404 andcontainer410 are positioned over theprobe402. Thetop sides406 of thecover404 are then folded up, off of thecontainer410 and onto theprobe410. Because thetop sides406 were stretched to fit over thecontainer410, thetop sides406 will retract inward and form a snug fit on theprobe end401. At this point, thecover404 is on theprobe402. Referring toFIG. 15, thecontainer410 is then removed from theprobe402, leaving thesterile probe cover404 on theprobe transducer end402. During the process, the sterile probe cover remains sterile, because the operator only touches thecontainer410. Thesterile probe cover404 is never touched by the operator.
• It should be appreciated that theassembly400 can be preassembled so that thetop portion406 is folded downward over the top of thecontainer410. Thecover404 may need to be stretched in order to do so, and so that thecover404 fits the probe. In accordance with one embodiment of the invention, the probe cover is less than 3 inches deep, 4 inches in width and 4 inches in height. It will be appreciated that while a snugfitting cover404 is provided in the current embodiment, a longer and looserfitting cover404 can be provided that is secured to theprobe402 by rubber bands or the like.
The Ultrasound Introducer Kit
• One object of the invention is to provide a catheter introduction set that is particularly well suited for use with a single hand. The catheter introduction set includes a proximal end and a distal end, with the proximal end able to couple with a needle. The introducer device can either come packaged and mated with a catheter and introducer needle, or be mated by the user with another prepackaged needle. To enable single-handed use, the means to control the guide-wire is located within the proximal two-thirds of the catheter introduction set. An additional inventive step enabling single-handed use is the introduction of cannula progression means that are located within the proximal two-thirds of the catheter introduction set.
• Turning toFIGS. 16-18, another embodiment of the invention is shown. Here, anintroducer kit500 is provided. Thekit500 includes a case orbox501 having a base502 and a lid or top504. Thebox501 is rectangular in shape and the top504 is larger than the base502 so that it is easy to remove the top504. As best shown inFIG. 17, the box also has a bottom506. Apad508 is provided at the exterior surface of the bottom506. Thepad508 can be at a portion of the bottom506 or extend the entire width and height of the bottom506. Referring toFIG. 18, the patient can rest his/her arm on thepad508 during IV placement or other medical procedure. Thepad508 stabilizes a body part that is to be catheterized. In the embodiment shown, thepad508 of thekit case500 stabilizes the patient's arm at the elbow to assist in catheterization of the anti-cubital veins. In an alternative embodiment of the invention, the bottom506 can have a concave shape instead of apad508.
• Thebox501 has an interior space that is used to retain medical equipment that is useful for a medical practitioner to perform a medical process, in particular an ultrasound assisted vessel cannulation. Thus, thekit500 includes all the single-use components necessary for ultrasound assisted vessel cannulation, including: catheter introducer10 (FIGS. 1-10); catheter tubing300 (FIG. 11); probe cover set400 (FIGS. 13-15); lidocaine solution; sterilizing solution and applicator; suture material; suturing needle; gauze pads; scalpel; drape with adhesive; towel; sterile US gel packet; two rubber bands; directional marker; normal saline flush; and tourniquet. It will be appreciated, however, that thekit500 need not include every single element listed here, and still be within the spirit and scope of the invention. In particular, theintroducer10,catheter tubing300, and probe cover set400 of the invention need not be provided with thekit500, and any conventional introducer, catheter tubing and probe cover can be provided. Thebox501 and its contents can be placed in a heat-sealed plastic bag and sterilized.
• For use in vessel cannulation, the patient is first placed in a recumbent position. After the contents are removed from the sterile package thebox501 is flipped so that the ergonomically designed bottom faces up and the elbow is placed on this surface to facilitate stabilization for cannulation. The kit keeps all necessary materials located in a single convenience place in a sterile manner. Thebox501 provides arm stabilization for sale and successful cannulation.
• The foregoing description and drawings should be considered as illustrative only of the principles of the invention. The invention may be configured in a variety of shapes and sizes and is not intended to be limited by the preferred embodiment. Numerous applications of the invention will readily occur to those skilled in the art. Therefore, it is not desired to limit the invention to the specific examples disclosed or the exact construction and operation shown and described. Rather, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

Claims (19)

1. A wire introduction device for introducing a guide wire into a body of a patient, the device comprising:

a housing body; and

a wheel rotatably coupled with said housing body, said wheel connected to the guide wire and configured to advance the guide wire into the patient body upon rotation of said wheel.

2. The wire introduction device ofclaim 1, further comprising a drive wire connected to the wheel, and a connector connecting said drive wire to the guide wire, wherein rotation of said wheel advances the drive wire which in turn advances the guide wire.

3. The wire introduction device ofclaim 2, further comprising a drum connected to said wheel, wherein the drive wire is coupled with said drum.

4. The wire introduction device ofclaim 2, further comprising a rear opening located at a rear end of said housing, wherein said drive wire and the guide wire extend through the rear opening.

5. The wire introduction device ofclaim 4, further comprising a sheath positioned about the drive wire and guide wire at the rear opening of said housing.

6. The wire introduction device ofclaim 1, further comprising an opening at a front end of said housing body, wherein the guide wire extends through the opening.

7. The wire introduction device ofclaim 6, further comprising an elongated coupling projecting outward from said housing body about said opening and configured to receive a needle having a central opening, wherein the guide wire extends through the central opening of the needle.

8. The wire introduction device ofclaim 1, wherein said wheel has an outer circumferential edge with ridges, and further comprising a tab coupled to said housing and configured to engage the ridges and prevent said wheel from backward rotation while allowing forward rotation of said wheel.

9. The wire introduction device ofclaim 1, wherein said device is configured for single-handed operation, whereby the user can hold the device in a single hand and operate said wheel with an index finger of said hand.

10. A catheter comprising a tube for insertion into a human body, and a tab extending from said tube, said tab coupled to said tube and configured to facilitate insertion of said tube into the human body.

11-17. (canceled)

18. A sterile probe cover assembly comprising:

a container having a top edge; and

a probe cover having one or more sides, said one or more sides having a top portion, whereby said one or more sides are received in said container and the top portion of said one or more sides is folded down over the top edge of said container.

19. The probe cover assembly ofclaim 20, wherein the cover is configured to fit over an ultrasound probe.

20. The probe cover assembly ofclaim 20, wherein said assembly can slide over the ultrasound probe, the top portion of said one or more sides folded up and onto the probe, and the container removed.

21. (canceled)

22. A intravenous deep vein kit comprising: a box, and one or more intravenous medical devices contained within the box.

23. The kit ofclaim 22, said box having a bottom configured to stabilize a body part to be catheterized.

24. The kit ofclaim 23, further comprising a cushion affixed to the bottom of said kit.

25. The kit ofclaim 23, wherein said bottom has a concave form to stabilize an elbow and arm to facilitate alignment of the arm for catheter placement.

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