INTRAVENOUS CATHETER

Intravenous catheter system includes a housing and a guidewire completely disposed within the housing. The system can also include a guide wheel disposed in the housing and operable to rotate about a first axle. The guide wheel can include an inner surface configured to engage the guidewire and move the guidewire. Additionally, the system can include a support wheel operable to engage the guidewire opposite the guide wheel. The support wheel can rotate about a second axle.

FIELD

The present disclosure relates generally to an intravenous (IV) catheter. In at least one example, the present disclosure relates to an IV catheter that includes a guidewire.

BACKGROUND

Most IV catheters used today in the United States lack guidewires for IV catheter placement. Some IV catheters do include guidewires.

DETAILED DESCRIPTION

It will be appreciated that for simplicity and clarity of illustration, where appropriate, reference numerals have been repeated among the different figures to indicate corresponding or analogous elements. In addition, while specific details are set forth in order to provide an understanding of the examples described herein, it will be appreciated by those skilled in the art that the examples described herein can be practiced without these specific details. In other instances, methods, procedures and components have not been described in detail so as not to obscure the related relevant feature being described. Also, the description is not to be considered as limiting the scope of the examples described herein. The drawings are not necessarily to scale and the proportions of certain parts may be exaggerated to better illustrate details and features of the present disclosure.

Several definitions that apply throughout this disclosure will now be presented. The term “coupled” is defined as connected, whether directly or indirectly through intervening components, and is not necessarily limited to physical connections. The term “communicatively coupled” is defined as connected, either directly or indirectly through intervening components, and the connections are not necessarily limited to physical connections, but are connections that accommodate the transfer of data between the so-described components. The connection can be such that the objects are permanently connected or releasably connected. The term “outside” refers to a region that is beyond the outermost confines of a physical object. The terms “comprising,” “including” and “having” are used interchangeably in this disclosure. The terms “comprising,” “including” and “having” mean to include, but not necessarily be limited to the things so described. The term “substantially” is defined to be essentially conforming to the particular dimension, shape or other word that substantially modifies, such that the component need not be exact.

A problem with the older style IV catheters is that it's possible to get a blood flash, indicating that the needle is in the vein lumen, however the plastic catheter that is over the needle is still outside the vein. This is because there is an offset between the distal end of the needle and the start of the plastic catheter that is over the needle. This can lead to inappropriate placement of the catheters and failed IV attempts once the operator tries to advance the plastic catheter when it is partially or completely outside the vein. A potential way to prevent this from happening is using a guidewire that goes through the needle and then advancing the plastic catheter over the guidewire (Seldinger technique).

An issue with the current guidewire assisted intravenous catheters on the market today is a lack of a familiar hand position for advancing the guidewire and catheter with one finger. Many operators who place non-guidewire intravenous catheters do so in a usual fashion of having their thumb and middle finger on each side of the needle grip and their index finger on top of the catheter near a push off tab. Up until the present disclosure, there is no IV catheter on the market with a built-in all-inclusive IV catheter system that allows for an obvious blood flash similar to previous IV catheters, and a front wheel that allows for similar one handed biomechanics for advancing both a guidewire and catheter with the same finger. There is an introducer device on the market that utilizes a front wheel to direct a guidewire, U.S. Pat. No. 10,143,826 B2, however this is an introducer device only that needs to adjoin to another IV catheter and not an all in one IV catheter device. Also, introducer device prevents a blood flash from being visible with many of the IV catheters available on the market, limiting its function to mainly being utilized with ultrasound. Up until now there is no built-in all-in-one IV catheter with a front wheel guidewire system that helps achieve similar biomechanics to previous non-guidewire IV catheters that also allows for a familiar blood flash. The current all-in-one guidewire IV catheter on the market (AccuCath®) has a slide for advancing the guidewire through the needle that cannot be done with one hand alone. The presently available IV catheter also makes it difficult to see blood flash contained within the plastic catheter portion and lacks the more familiar blood flash chamber. With the vast advancement of ultrasound in the last decade, it is important to be able to get an obvious blood flash and then advance an IV guidewire/catheter system with one hand alone so the operator's other hand can simultaneously operate an ultrasound probe. The AccuCath® IV catheter lacks this capability as the ultrasound probe needs to be put down so the operator can advance the guidewire and catheter with their free hand.

Up until now, guidewire assisted intravenous catheters have lacked a blood flash similar to catheters without guidewires. Having a guidewire already in the needle can interfere with blood return ultimately leading to a less obvious flash of blood when the needle enters the vein. The problem with the introducer device, is that the device has to connect directly to the needle blood return system so that the guidewire can advance through the needle, however this prevents a blood flash. This would make using this introducer device impractical if not impossible without an ultrasound machine. The AccuCath® has a difficult to see blood flash within the catheter itself and lacks a traditional blood flash chamber to alert the operator that the needle has entered the vein. An obvious blood flash is important for operators to know that they are in the vein lumen prior to advancing the guidewire, especially without ultrasound guidance.

The solution of the present disclosure to the biomechanics problem of previous guidewire IV catheters is a built-in guide wheel. A guidewire can be located either entirely or partially inside of the housing. The guidewire can be advanced with one finger (for example the index finger, but different fingers are within the scope of this disclosure). Once the guidewire is in the vein, the operator can then use his/her same finger to advance a plastic catheter. In at least one example, a push off tab can be provided on the plastic catheter.

One example of a device according to the present disclosure has a passageway formed in a housing of the device. The device also includes a guidewire that is at least partially contained within the passageway and a guide wheel that extends partially within the housing and is operable to advance the guidewire from the passageway through a needle of the device into a patient. As the guidewire is advanced by rotating the guide wheel, the guidewire can exit the catheter and into a vein of a patient. As the guidewire does not extend past an aperture formed in a needle of the catheter, blood can leave the needle through the aperture into a blood flash chamber, the guidewire does not interfere with blood return into the flash chamber. Therefore, in at least one example, the present disclosure provides for a blood flash that is visible through the housing. Once the blood flash is obtained, the operator can turn the guide wheel, advancing the guidewire further into the needle, past the aperture in the needle, and then into the patient's vein. Once the guidewire is fully inserted, the operator can slide a plastic catheter over the needle and further into a vein lumen. The plastic catheter can remain in the vein of the patient, while the guidewire and needle can be removed from the patient.

The all-inclusive IV catheter of the present disclosure contains a built-in guide wheel for one handed guidewire advancement to help provide proper biomechanics for IV catheter insertion. The present design allows for the complete process to be finished with one hand and the present design allows for a blood flash so that it can be used easily with or without an ultrasound machine. The one-handed technique frees up the operator's other hand. The other hand can be used for interacting with the ultrasound machine therefore allowing the operator to use both the present IV catheter and the ultrasound machine at the same time during the entire procedure.

Once the guidewire has been extended to the proper position. The plastic catheter can be inserted over the guidewire with the same finger that was used to advance the guidewire. The plastic catheter is configured to remain inserted until it is no longer needed. The plastic catheter can have a connection port on the exposed end. The connection port can allow for a future IV connection to be established. The plastic catheter can be removed when the IV port is no longer needed.

FIG.1illustrates an example of the intravenous (IV) catheter guidewire system or device100according to the present disclosure. The IV catheter device can be in an outer housing102. The outer housing102can be operable to be handheld. In at least one example, the housing102, can be made in two pieces. The device100can also include a guide wheel110. As detailed herein, the guide wheel110can be used to advance a guidewire. The housing102has a distal end122that a needle103extends from. The needle103has a distal end107that is located farthest away from the housing102. The distal end107can be tapered or sloped to allow easier penetration of the patient's skin and/or the patient's vein.

The guide wheel110can be positioned close to the distal end122of housing102. The distance of the guide wheel110from the distal end122can be less than 25% of an overall length of the housing102. In another example, the guide wheel110can be located a distance of less than 10% of the overall length of the housing102from the distal end122. The distal end122of the housing102is the portion of the housing closest to the needle103and/or the patient during the procedure.

As shown inFIG.2, the device100can be used with one hand104by an operator106placing one finger108on a guide wheel110to operate the guide wheel110. In at least one example the one finger108can be an index finger302. The operator can grip the system using a middle finger304and a thumb306, while the index finger302is free to rotate the guide wheel110. The grip illustrated inFIG.2can be used in the other figures as well, but the views limit the ability to show the grip for clarity purposes. The plastic catheter can be implemented with the system shown inFIGS.1and2or in some examples, the plastic catheter can be omitted. The distal end of the plastic catheter120can be tapered as shown or in other examples can be straight.

FIG.3illustrates the general appearance of the intravenous catheter device100, primarily in section, with a guidewire124built to interact functionally with the guide wheel110. A plastic catheter120is attached to the distal end122of the housing102. In at least one example, the plastic catheter120can be detachable from the housing102. In another example, the plastic catheter120can be configured to be releasably retained by the housing102thereby preventing separation of the plastic catheter120from the housing102during normal operation.

A blood flash chamber130can be located within the housing102. The size of the blood flash chamber130is for illustrative purposes only. The blood flash chamber130can be located at or proximal to the distal end122of the housing102. The blood flash chamber130can be much smaller relative to the housing102than the one shown. The blood flash chamber130can be sufficiently clear and/or translucent to allow the operator106to see blood filling the blood flash chamber130. In at least one example, the blood flash chamber130can be integrally formed with the housing102. In another example, the housing102can be formed around the blood flash chamber130. Blood from a patient flows from the distal end107through the needle103until it reaches the aperture135of the needle103. An aperture135is formed in the blood flash chamber130. In at least one example, the aperture135can be a hole that is substantially round. In other examples, the aperture135can take on other shapes such as a square or rectangular shape. The shape of the aperture135can be made such that blood freely flows into the blood flash chamber130.

FIG.4illustrates inserting the distal end107into a vein136of a patient. Once the needle103has entered the vein, blood flows into the blood flash chamber130.FIG.4further illustrates, once the blood flash is obtained, rotating the guide wheel110with the pad109of a finger108. The rotation of the guide wheel110causes the guidewire124to go from a retracted position to a fully extended configuration as further described inFIG.5. The needle103can fill the blood flash chamber130through aperture135once the vein136is entered by the distal end107of the needle103since there is no guidewire obstructing blood flow into the chamber130. Note that the chamber130is enlarged in this view relative to the housing102, but the size of the chamber130can vary, while the blood flash function can be representative regardless of the scale to the housing as a flash of blood. A plastic catheter120extends over the needle103and in at least one example is releasably detachable. Blood return occurs at the aperture135. This is also a signal to operate the guidewire124. This can also be a signal to turn the guide wheel110and advance the guidewire124.

FIG.5illustrates a configuration in which the guidewire124is fully extended in the patient138. The guidewire124exits the distal end107of the needle103, such that a portion of the guidewire124is located above the aperture135. The guidewire is operable to go further into the needle103and ultimately into a vein136. An inner track125directs the guidewire124into guide wheel110and support wheel112. The guidewire124exits from contacting with the guide wheel110and support wheel112and goes through the needle103. The ball element123disposed on the trailing end303of the guidewire124. Additionally, the ball element123centers the guidewire124in the track125and stops the guidewire124from proceeding beyond a ball stop121at the end of the track125. As illustrated, the guidewire124is fully advanced into the patient. The advancement of the guidewire124is caused by a pad109of a finger108rotating the guide wheel110until the guide wheel stops rotating due to contact of the ball element123with ball stop121. In one example, the ball element123can be disposed on a trailing end303of the guidewire124. A distance305(shown inFIG.6) between the guide wheel110and support wheel112can substantially be the diameter of the guidewire124. The diameter307of the ball element123can be substantially larger than the distance305. In at least one example, substantially larger refers to the ability of the ball element123to stop the advancement of the guidewire124past the ball stop121. In at least one example, the diameter307of the ball element123is at least twice the distance305.

The operator can use the same finger108(for example, an index finger302) that turned the guide wheel110to push on the push off tab142to advance the plastic catheter120over the guidewire124and into the vein136. As illustrated inFIG.5, an operator can use a finger108, for example an index finger302, to advance the plastic catheter120with the help of a push off tab142. The operator waits until the plastic catheter120is within vein136to advance the plastic catheter120from the retracted position shown in solid lines to the advanced position shown in dashed lines. The guidewire124assists in making sure that the plastic catheter120stays within the vein of the patient during further insertion by serving as a centering mechanism for the plastic catheter120. The needle103allows for initial penetration of the skin and vein of the patient. When blood enters the blood flash chamber130, the flash provides for further indication that vein of the patient has been penetrated by the needle103. The plastic catheter120can remain in place to provide for an IV port. The IV port on the end of the plastic catheter120allows for insertion of a variety of different IV injections, including but not limited to shots and/or drip bag installations. Once the need for the IV port is no longer, the plastic catheter120can be removed.

FIG.6illustrates grip locations131,133are on each side of the guide wheel apparatus111that includes the guide wheel110. In at least one example, the grip locations131,133can include a textured surface. The textured surface can include a plurality of ridges and valleys. In another example, the texture surface can be knurled. The textured surface can provide for an enhanced grip on the guide wheel110by the operator. The operator will be wearing a glove or have hands that are slippery. The guide wheel apparatus111allows the guidewire124to pass between the guide wheel110and the support wheel112, which are each mounted to rotate on axles162and164respectively. While the axles162and164are shown where they have a portion that is on the outside of the guide wheel apparatus111, the axles162can be molded with guide wheel apparatus111. As illustrated the guide wheel110is operable to rotate about a first axle162. The support wheel112is operable to rotate about a second axle164. The first axle162and the second axle164can be arranged to be vertically aligned. Additionally, the first axle162and the second axle164can be arranged that a line that bisects the center of the first axle162and the second axle164is perpendicular to the needle103. Furthermore, in other examples, the exterior portions can be made flush or recessed relative to the guide wheel apparatus111so that snags are less likely to happen. The guide wheel110and the support wheel112and are disposed to frictionally engage the guidewire124to move the guidewire124forwardly or backwardly in response to movement of the guide wheel110by the finger108of the operator106. The part of the guide wheel110that has contact with the guidewire124can be covered with a plastic or rubber type of material (for example, thermoplastic polyurethane but not limited to this material) that allows the guidewire124to be gripped by the guide wheel110and prevent slippage of the guidewire124. In at least one example, the support wheel112can have a similar covering.

The guidewire124is contained within the device100. As illustrated the guidewire124is located within the housing102of the device100. The guidewire124does not extend beyond a portion of the blood flash chamber130in the retracted or shipping configuration. Once the device100is ready for use, the guidewire124can be advanced as described herein to extend beyond the device100. In the retracted configuration, the guidewire124is positioned such that blood can flow through needle103into the aperture135formed in the blood flash chamber130. The guidewire124can be made of a material such as nitinol or other similar alloy metals that can allow for frictional contact with the guide wheel110and support wheel112and then be able to be guided through the needle103and exit the distal end107of the needle103into the vein136. The guidewire124can advance past the aperture135towards the distal end107of the needle103.

FIGS.7to10illustrate an alternative example of the system or device200where the guidewire224is provided a longer length of travel in a shorter length of housing202in the same general outer configuration but shorter in length. Thus, the track225can be made longer than the length of the housing202. The track225includes a curve that allows for a portion of the housing202to have a track225that is more than double the length of a straight track225. The track225can include a portion that is substantially parallel to the exterior of the housing202. Additionally, the track225can include a portion that is sloped relative to the exterior of the housing202. The guide wheel210and support wheel212can be the same or very similar configuration as the prior example described above, but an extended track225is included that adds a distance of travel for the guidewire within the housing202and curves within the housing202as shown. A ball element223is disposed at the end of the guidewire224within the track225to center the guidewire224in the track225. The ball element223is designed such that the ball element is prevented from further advancement by ball stop121. The ball stop121can be formed as a wall with an opening formed therein. In other examples, the track225can be molded, printed, and or constructed such that the wall is formed as part of the creation of the housing202including the track225. The guidewire224moves between the guide wheel210and the support wheel212which are each mounted to rotate on axles262and264respectively and disposed to frictionally engage the guidewire224to move the guidewire224forwardly or backwardly in response to movement of the guide wheel210by the finger108of the operator106. In all other respects, this example would function in a similar manner as that ofFIGS.2through6. The guidewire224movement would occur after the blood flash appears in the chamber130after engagement of the vein136(FIG.8) and subsequent blood flow into the chamber130(FIG.9). The blood flash indicates to the operator that the vein has been penetrated properly. The operator then rotates the guide wheel210, which engages with the guidewire and advances the guidewire through the needle103and out the distal end107of the needle103. Once the guidewire224is advanced the full length, the operator then slides the plastic catheter120into the vein. The plastic catheter120is guided by the guidewire224. Once the plastic catheter120is installed, the device200can be removed leaving the plastic catheter120in place in the patient138. In the illustrated example ofFIG.9relative toFIG.5, the track length is increased. In other examples, the track length can remain the same, but the housing of the device can be reduced accordingly.

FIGS.11through14disclose a further example of the disclosure having a shorter length housing502and a guide wheel510in which the guidewire524wraps around the guide wheel510as it is manipulated by the finger108of an operator106.FIG.11illustrates the general appearance of the intravenous catheter guidewire system or device500with a guidewire524built into the guide wheel510. The guidewire524wraps around the guide wheel510multiple times with the end of the guidewire positioned so as to not pass the aperture503in a retracted configuration. The guidewire524is positioned in the retracted or original configuration such that the guidewire524wraps several times around the guide wheel510. The guidewire524is coupled to the guide wheel510by a tensioner550. The guidewire524continues through a passageway552formed in the housing502. The guidewire524continues through at least a portion of the needle531and past the distal end507of the needle531.

When the operator inserts the device500into the patient138, the distal end507of the needle531is configured to penetrate the patient and the vein of the patient. As the guidewire524is in the retracted state, blood can flow through the needle531into the blood flash chamber530. The blood flash chamber530is shown as a clear plastic portion of the housing502that is visible to an operator106and that should fill with an obvious blood flash since there is no guidewire obstructing blood flow into the chamber530via an aperture503. The guidewire524is originally disposed just inside the needle534above the aperture503located in the needle534(FIG.11). In at least one example the passageway532The guidewire524moves from the guide wheel510into a passageway552in the housing502into the needle534. Blood return occurs at the aperture503and should cause a blood flash once the distal end507of needle531is inside the vein136of a patient138(the guidewire524blocks return through the end of the needle534). A push off tab542is connected to the plastic catheter520and assists with pushing the catheter520into the vein136and disconnecting with the housing502with one finger108after the guidewire524has been advanced as shown inFIG.13.

A spring loaded tensioner550is fixed to the housing at one end via a securement element555and wrapped around the guidewire524on the guide wheel510to control the radial position of the guidewire524on the guide wheel510as it is reeled in or out during movement of the guide wheel510and relative movement of the guidewire524. The guidewire524is wrapped around the guide wheel510more than one time, generally, and is secured to the guide wheel510at the end opposite to the end entering the vein136. This construction permits more linear travel of the guidewire524in a shorter length of housing502to obtain the same results as described above. The tensioner550is shown separately inFIG.14and would conventionally be made from a spring steel material, preferable stainless steel, with a securement element555either welded to the steel if a metal stop or molded to the steel if a plastic element. The guide wheel510may be larger in diameter than the guide wheels of the other examples to accommodate more travel for fewer turns of the guide wheel510as the guidewire524wraps around the guide wheel510.

In this case the guidewire524will be covered by a plastic material (but not limited to plastic material) to help keep it sterile. This covering will protect the guidewire524from the operator's gloved finger108.

It should also be noted that with slight modifications in needle length and types of plastic catheters, the disclosure can be used with central and arterial lines in the same manner as described above.

The instant disclosure has been described in an illustrative manner, and it is to be understood that the terminology which has been used is intended to be in the nature of words of description rather than of limitation. Obviously, many modifications and variations of the instant disclosure are possible in light of the above teachings. It is, therefore, to be understood that within the scope of the appended claims, the instant disclosure may be practiced otherwise than as specifically described.