Patent Application
20210093837
The invention herein described is an improvement to the Flash Chamber Express system as described in patent documents filed by William L. Spearman (and assigned to AV Starr Innovations LLC) in U.S. Pat. Nos. 8,702,658 and 8,728,038 and U.S. Ser. No. 15/444,291 filed Feb. 27, 2017 (the pending patent application U.S. Ser. No. 15/444,291 is sometimes called the Plunger Patent in this document). The specifications and drawings of these patent documents are hereby incorporated by reference into this document.
The present invention relates to an IV catheter insertion device having a flash chamber which fills with blood to indicate that the IV catheter has been inserted into the proper location within the vein. In some applications of the insertion device, it is desired to safely access the blood from its flash chamber on demand.
A patient admitted to a hospital, an outpatient treatment center, or an outpatient surgery center will have an intravenous (IV) catheter inserted for easy access for fluids and drugs to be administered to the patient. The IV catheter is typically inserted using an IV catheter insertion device, and some of these IV catheter insertion devices have become known in the industry as JELCOs after the name of one company which brought these insertion devices to market. In addition to placement of an IV catheter, it is frequently necessary for a sample of the patient's blood to be obtained—e.g., for testing, blood typing or other analysis. For many of these blood tests, only a small sample of blood is required. After the IV catheter has been inserted, the healthcare worker may obtain this blood sample by various means. One method would be to have the patient endure another needle stick either by a needle and syringe to draw an aliquot of blood, or by pricking the patient's finger with a lancet for a few drops of blood. Several different types of intravenous (IV) catheter insertion devices currently are on the market. One such IV catheter insertion device is marketed by Smiths Medical under its ProtectIV trademark. This device can be seen represented by U.S. Pat. No. 5,000,740. This device uses a passive system to protect the user from needle stick injury. In its design, this device has a non-removable flash chamber filter. The invention described in this application provides a method and device to allow the user to safely and efficiently access the blood within the flash chamber of these IV insertion devices with a nonremovable flash chamber filter. As patients are treated in the emergency room or prepared for surgery in surgical suites, they often require additional blood testing, such as blood glucose, hemoglobin, pregnancy test, etc. With current point of care (POC) blood testing devices, these test results can be obtained with small volumes of blood, usually one or two drops of blood. Some have proposed to use some of the blood that remains within the JELCO or IV catheter insertion device after the IV catheter has been inserted in a patient for these simple blood tests. Most IV catheter insertion devices include an integrated flash chamber. As the operator inserts the needle of the IV catheter insertion device into the patient's vein, red blood appears within the flash chamber of an IV catheter insertion device, sometimes referred to as a flash of blood. This flash of blood that occurs within the flash chamber shows the operator that the IV catheter has properly entered a vein. The operator watches the flash chamber continuing to fill with blood as the operator advances the IV catheter into the vein, thereby ensuring the IV catheter remains properly positioned within the vein. Usually the proximal end of the flash chamber is blocked by a flash plug. The flash plug typically includes a filter material that allows air to vent from the flash chamber as the blood or fluid fills the chamber, but prevents the blood or fluid from passing from the flash chamber. IV catheter insertion devices of the prior art may have one of two different types of flash plugs. One type of IV catheter insertion device, such as described in U.S. Pat. No. 5,000,740, has a fixed, or non-removable, flash plug. Another type of prior art IV catheter insertion device is seen in U.S. Pat. No. 4,917,671; this type of IV insertion device has a removable flash plug and filter at the proximal end of its flash chamber. When an IV catheter has been placed within the vein, the remainder of the JELCO or IV catheter insertion device is removed from the patient. A small amount of the patient's blood remains within the flash chamber of the JELCO or IV catheter insertion device. By accessing the patient's blood from the flash chamber of the IV catheter insertion device for POC testing, the operator may be able to avoid an additional needle stick to the patient. There are some known approaches to access blood in the flash chamber of an IV catheter insertion device. One IV catheter insertion device, such as U.S. Pat. No. 5,000,740, which is currently marketed by Smiths Medical under its ProtectIV trademark, offers a unique problem when trying to access the blood within the flash chamber since it has a non-removable flash plug. As the flash plug is non-removable, users must adapt special methods if they wish to access the blood within the flash chamber. One such method to access blood in this IV insertion device with a non-removable flash plug involves finding and using an external probe, such as a pen or a golf tee, to push the internal flash plug filter within the flash chamber to expel blood from the flash chamber. The use of an external device such as a golf tee or pen is undesirable for several reasons. The external device must be stored some place that is easily accessible to the operator when the operator is ready to use it. The use of such an external device may be undesirable for safety reasons. If the worker were to reuse any external probe or device (including a pen or a golf tee), cross-contamination may occur from one flash chamber to another, putting other patients and the healthcare worker at risk. In addition the user must align the external probe with the flash plug while pushing the device and flash plug forward within the flash chamber while at the same time keeping the tip of the needle over the correct spot on the testing strip. Spearman patents U.S. Pat. Nos. 8,702,658 and 8,728,038, addressed many of these issues with a device that was built into such an IV catheter device or was attached after-market to provide easy access to the blood within the flash chamber of an IV device with a non-removable flash plug. While these described devices provide easy access to the flash chamber blood in IV devices with non-removable flash plugs, one described device must be included during manufacture of the IV catheter device. The other described device can be attached after market, but must be aligned correctly to the IV catheter insertion device during attachment which, for some operators, makes attachment difficult. The new invention may be used after the IV catheter has been inserted and therefore does not require the manufacturer to include the new invention during production of the IV catheter device. In addition, the new invention is much easier to insert and, by design, aligns easily with the flash chamber filter making for easier attachment by the operator. Prior art, including Spearman patents U.S. Pat. Nos. 8,702,658 and 8,728,038, show a device made of two parts, typically a collar and a plunger. The collar is secured within a section of the IV insertion device (ProtectIV by Smiths Medical) and aligns the plunger with the flash plug filter. The separate plunger moves within the structure of the collar from position one to position two. As the plunger advances, it pushes the flash chamber filter into the flash chamber which expresses the blood within the flash chamber out of the flash chamber through the attached needle to allow the user to drop the blood onto a testing strip. The new device described herein combines the two parts into a single structure. The outer tube of the new device fits within the walls of the finger grip of the ProtectIV device. The fit of the walls of the outer tube aligns the central plunger within the tube with the flash plug filter. The entire device can then be advanced from position one to position two. As the device is advanced, the walls of the outer tube maintain alignment of the attached plunger such that as it is advanced, the tip of the plunger forces the flash plug filter distally into the flash chamber. The advancement of the plunger, and therefore the flash plug filter forces the blood within the flash chamber distally, expressing it from the flash chamber out through the distal tip of the needle from where it can be directed onto a blood testing strip. As the design of the outer tube maintains alignment of the plunger and the flash plug filter, the user does not need to look at the alignment of the distal probe with the filter and can then keep his/her attention on directing the blood onto the testing strip. As the new device can be manufactured as one piece, rather than two separate pieces that must be assembled, the cost of manufacturing is greatly reduced. In addition, as a one-piece design, the new device could also be incorporated into the packaging of an IV insertion device or other similar medical device. For example, every IV catheter comes packaged with a needle cover to protect the needle and prevent accidental needle sticks while handling the device prior to insertion of the IV catheter. This needle cover is usually discarded after uncapping the needle of the IV device. A change to the design of the needle cover could incorporate the single piece device, as will be described herein. This design would not change the function of the needle cover but would add a device to express blood from the used IV catheter insertion device when needed. Indeed, one might also incorporate the design to be included within a cap or other packaging of similar devices such as blood lancets or syringes that could then do double duty as normal caps or covering and a device to express blood from the depicted IV catheter device. The present invention addresses some of these undesirable limitations of prior art to provide an improved device and method for accessing blood from an IV catheter insertion device that has a nonremovable flash plug filter. It is desirable that any part of an IV catheter insertion device (or JELCO) be simple to make. It is also desirable that the device be self-contained and not require additional tools, e.g., an external device like a golf tee or pen, in order to access the blood contained in the flash chamber. If the device is not included during manufacturer of the intravenous catheter insertion device, it is further desirable that the device can be attached to the IV insertion device after the IV catheter is placed and the insertion device has been separated from the IV catheter. The present invention overcomes the disadvantages and limitations of the prior art systems while providing a simple, yet effective, way of accessing the blood contained in the flash chamber of an IV catheter insertion device for testing and analysis without need for a golf tee or ballpoint pen. The present invention overcomes some of the limitations and disadvantages of prior art systems. The present invention provides a way of using an IV catheter insertion device of the prior art while being able to access blood which is located within the flash chamber for testing. The present invention has the advantage that it works with flash plugs which are not removable (for example, as described in U.S. Pat. No. 5,000,740). The present invention improves upon the prior disclosures in the Spearman patents U.S. Pat. Nos. 8,702,658 and 8,728,038. Other objects and advantages of the present invention will be apparent to those of ordinary skill in the art to which the present invention applies in view of the following detailed description of the preferred embodiment taken in conjunction with the accompanying drawings.
Review of prior art: A review of the workings of an intravenous catheter insertion device such as is sold under the ProtectIV trademark will allow the reader to better understand the present invention.
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The present invention may be viewed as a method of manufacturing where a plunger component can be incorporated into a single-piece needle cover and the single-piece needle cover could be manufactured in a single step, such as molding it from a suitable plastic material. Then the user (the healthcare professional) would have at hand a plunger structure merely by removing the protective needle cover as a part of his process for preparing the IV catheter insertion device for use (and would not have to seek a separate part for the function of pressing on the internal flash plug to expel the blood).
Accordingly, the present invention might be seen as a method for using the structure of the improved IV catheter insertion device to provide a tool for expelling blood from the IV catheter insertion device without the necessity for finding a separate tool for pushing on the flash plug to expel blood from the flash chamber.
Of course, many modifications and adaptations of the preferred structure can be made without departing from the spirit of the present invention. For example, the cap structure may have any desired configuration and need not be a particular design or even have symmetry about an axis (in the form a cylindrical structure). Although the cap structure which doubles as a plunger has been described in its preferred embodiment as a single piece of molded plastic, it could be made in a plurality of pieces, if desired, and the insertion device may include additional structure such as a spring to withdraw the needle after it has been used. Additionally, while a molded plastic protective cap is beneficial in some applications, the protective cap could be formed of other materials and/or formed in other manners, if desired, and the plunger portion could be formed as a removable part of the larger protective cap, if desired. Thus it would be appreciated by a man of ordinary skill in the relevant art that the foregoing teaching of the present invention is illustrative of the principles of the present invention and not in limitation of the invention, as the present invention is defined by the claims which follow.
