INTRAVENOUS CATHETER STOPPER

A stopper is provided for preventing blockage of a cannula of an intravenous catheter in-between uses including a hub having a connector for securing to the catheter, and a stylet having a length and a shape configured to fill a lumen of the cannula, where the hub is configured to place the stylet within the lumen of the cannula, and where the stylet is configured to prevent blood from clotting within the lumen of the cannula when inserted in a patient between uses. In some implementations, the stopper can have a movable stylet. In an example, the stylet can have a variable stiffness configured to aid in moving and prevent blockage of the lumen by kinking of the cannula.

BACKGROUND

Intravenous catheters are used for intravenous (IV) access and providing IV therapy such as injection of medicine and/or fluid to a patient. IV therapy is beneficial for several conditions and medical situations including dehydration, nutrition, physiological shock, surgery, blood transfusions, chemotherapy and medication administration. There are many types of IV catheters that can be used for peripheral and/or central IV use. An example of an IV catheter is an over-the-needle catheter having a cannula that is inserted into a vein via a needle/trocar. The needle/trocar is inserted through a lumen of the cannula, where the needle/trocar is inserted into the vein and then withdrawn, leaving the cannula within the vein. IV catheters can be used intermittently; however, difficulty can arise when the cannula is blocked.

SUMMARY

A stopper is provided for preventing blockage of a cannula of an intravenous catheter in-between uses including a hub having a connector for securing to the catheter, and a stylet having a length and a shape configured to fill a lumen of the cannula, where the hub is configured to place the stylet within the lumen of the cannula, and where the stylet is configured to prevent blood from clotting within the lumen of the cannula when inserted in a patient between uses. In some implementations, the stopper can have a movable stylet. In an example, the stylet can have a variable stiffness configured to aid in moving and prevent blockage of the lumen by kinking of the cannula.

DETAILED DESCRIPTION

The present disclosure preferably can be used for IV catheters having a cannula for peripheral applications with intermittent use or infusion. In some cases, intermittent infusion is used when a patient requires IV therapy such as medication only at certain times, and does not require additional fluid.

IV catheters can be used with other IV therapy devices and equipment configured for intermittent use such as a syringe or tubing for an intravenous drip (e.g., pump or gravity drip). After the IV therapy is complete, the tubing is disconnected from the IV catheter and a protective cap is applied to the IV catheter. Difficulty can arise when the cannula is again fixed with the syringe or tubing.

In between uses, blood can clot within the lumen of the cannula so there is a need to “flush” the cannula before administering subsequent IV therapy. In some cases, when the clotted blood within the cannula is cleared with the flush, the clotted blood travels into the blood stream of the patient and can be lodged into the patient's lungs and lead to serious complications such as a pulmonary embolism. In some instances, the clotted blood can travel to the brain and lead to an infarction leading to weakness of a part of the body. In other cases it's not possible to dislodge the clot from the lumen of the cannula so the cannula has to be replaced. Replacing the cannula is painful, requires another peripheral vein location, a trained medical person to replace the catheter, and adds cost for another cannula.

Another common problem with IV cannulas is kinking. When the cannula is inserted into a vein in a part of the body that bends, such as the elbow or wrist, then a splint may be required to prevent the cannula from bending. Once the cannula is kinked, the cannula becomes blocked and the IV therapy cannot be administered. Similar to clotted cannulas, blocked cannulas need to be replaced.

FIG. 1Ais a drawing of a cross-section of a stopper110having a stylet112coupled to an intravenous (IV) catheter120having a cannula122, where the stylet112is extended through a lumen of the cannula122according to an example. The extension of a distal end112aof the stylet112, which is preferably rounded, is configured to at least substantially be equal to a distal end of the cannula122and is configured to prevent blockage of the lumen between uses of the IV catheter120in several ways.

In an example, the stylet112is coated with an anti-clotting agent configured to prevent blockage of the lumen. The stopper110and the stylet112can be made from similar biocompatible materials used in the IV catheter120such as polyurethane and PVC according to an example. In an example, the stylet112is configured to prevent blockage of the lumen by creating a physical obstruction of the lumen. In an example, the stylet112has a stiffness configured to strengthen the cannula122and to prevent blockage of the lumen by kinking of the cannula122.

In some implementations, the stylet112can have a varying stiffness along a stylet length. The stylet112can be configured to have a variable stiffness using a single material and different mechanical properties such as an aeration density and a varying physical structure. Alternatively, the stylet112can be configured to have a variable stiffness using a combination of materials with different hardness.

In an example, the stylet112can have a stiff proximal portion to aid in movement and prevent kinking and a soft or flexible distal portion within the cannula122. In an example, the varying stiffness along the length of the stylet112can be alternating segments of increased compliance and increased rigidity (not shown). In an example, the stiffness of the stylet112is complementary to the cannula122such that a combined stiffness of the stylet112and the cannula122is configured to prevent patient discomfort. In an example, a distal portion of the stylet112can have a lesser stiffness than a proximal portion of the stylet to prevent kinking of the cannula122and injury to tissue when the stylet112is inserted in the cannula122. In an example, a proximal portion of the stylet112can have a greater stiffness than a distal portion of the stylet112to aid in extending and retracting the stylet112.

In an example, a connecting portion of the stopper110(See310inFIG. 3A-3G) can have a complementary shape to a connecting portion of the IV catheter120(See210a-binFIG. 2A-2B) configured to form a flashback chamber130. The flashback chamber130is preferably transparent such that a proximal end of the cannula122can be visible.

FIG. 1Bshows a drawing of a cross-section of the stopper110connected to the IV catheter120, where the stylet112is withdrawn from the cannula122in a direction140. In some implementations, the stopper110can have a retractable stylet300c-dconfigured to enter and to withdraw from the lumen of the cannula122of the IV catheter120. (SeeFIGS. 3B-3G)

FIG. 1Cshows a hand150of a patient with the IV catheter120and the stopper110according to an example. The stylet112of the stopper110is within the lumen of the cannula which is inserted in a vein of the patient.

IV Catheter

FIG. 2Ais a drawing of a cross-section of an IV catheter120ahaving a cannula122configured to be inserted into the vein, a catheter connector210aconfigured to interface with IV therapy devices and equipment (e.g., the stopper110), and a pair of tabs220for securing the IV catheter120ato a patient's skin according to an example.FIG. 2Bis drawing of a cross-section of an IV catheter120bhaving a cannula122, a catheter connector210bthat includes a flow control valve212, and a pair of tabs220according to an example. The cannula122can have different lengths and lumen sizes which can be described by a gauge caliber.FIG. 8shows a table800listing sizes and calibers of the cannula122in gauge ranging from size 26 gauge (smallest) to size 14 gauge (largest) according to an example. In an example, the stopper110can be used with any commercially available I/V catheter having a cannula and can be provided in the market as a disposable with a color coding scheme according to a size of the lumen of the cannula and/or a flow rate.

Stopper

In some implementations, a shape and length of the stylet112is configured to prevent crystallization of medicine and blood from clotting within the lumen of the cannula122when inserted in a patient between uses of the IV catheter120. The lengths of small gauge cannulas are kept small to prevent clotting of blood and blockage of the cannula122. Using the stopper110, new cannulas having longer lengths can be manufactured and used for patient care.

The stylet112, when inserted into the lumen of the cannula122, is configured to prevent an incidence of blood clotting within the lumen of the cannula122. In an example, the stylet112is configured to have a shape and dimension to fill the lumen of the cannula122, as well as a length equal to the cannula122.

FIGS. 3A-3Fare drawings of cross-sections of different examples of the stopper110and are represented as300a-300d, respectively. Each stopper300a-dcan include a stopper connector310configured to securely mate with the catheter connector210of the IV catheter120and a lip320for aid in connecting the stopper110,300a-dto the IV catheter120.

Fixed Stylet

FIG. 3Ais a drawing of a cross-section of a stopper300ahaving a fixed stylet302that is fixed to either the stopper connector310or a hub330according to an example. As shown inFIG. 1A, when the stopper300ais inserted into the IV catheter120, the distal end (302a) of the stylet302is configured to be flush with the distal end of the cannula122.

Rubber Membrane

FIGS. 3B-3Care drawings of a cross-section of a stopper300bhaving a hub340with a rubber membrane342, a sliding stylet304, and a stopper connector310, where the sliding stylet304is movable according to an example. A distal end304aof the sliding stylet304of the stopper300bcan be extended past the stopper connector310(FIG. 3B) or retracted346behind the stopper connector310(FIG. 3C). In an aspect, the rubber membrane342is configured to grip the sliding stylet304and prevent the sliding stylet304from moving freely. Optionally, a proximal end304cof the sliding stylet304can include a handle344. The handle344can be used to by the user to manually pulling and pushing the sliding stylet304.

Roller

FIGS. 3D-3Eare drawings of a cross-section of a stopper300chaving a hub350with a roller352, a cogged stylet306, and the stopper connector310, where the roller352is configured to extend or retract a cogged stylet306by creating traction according to an example. In an example, a surface of the cogged stylet306can have a plurality of cogs307configured to aid in creating traction. In an example, the roller352includes a plurality of teeth353that are complementary to the plurality of cogs307of the cogged stylet306. In an example, a rotation of the roller352in a first direction354results in an extension355of the cogged stylet306, and a rotation in an opposite direction356results in a retraction357. When the roller352is rotated, the cogged stylet306is moved distally or proximally from the lumen of the cannula122. The roller352can be rotated by a user's thumb or finger. In an example, the roller352can be configured to turn a gear (not shown) with a set of complementary teeth with respect to the plurality of cogs of the cogged stylet306.

FIGS. 3F-3Gare drawings of a cross-section of a stopper300dhaving a hub360with a coiling retractor362, a coiling stylet308, and the stopper connector310, where the coiling retractor362is configured to coil the coiling stylet308within the coiling retractor362, according to an example. In an example, a proximal end308cof the coiling stylet308can be attached to a portion of the coiling retractor362such that a rotation of the coiling retractor362in a first direction364results in an extension365of the coiling stylet308, and a rotation in an opposite direction366results in a retraction367. When the coiling retractor362is rotated, the coiling stylet308is moved distally or proximally from the lumen of the cannula122. In an example, the coiling retractor362can include a spring configured to automatically recoil or to extend the coiling stylet308. In some implementations, the coiling retractor362can be filled partially or fully with an anti-coagulant agent to coat the coiling stylet308, which can further prevent clotting.

Protective Cap

FIG. 4Ais a drawing of a stopper110having a protective cap410for covering the stylet112when extended and not in use according to an example.FIG. 4Bis a drawing of a stopper110having a protective cap420for covering the stylet112when retracted and not in use according to an example. In some implementations, the protective cap410,420can be filled partially or fully with an anti-coagulant agent402configured to coat the stylet112and further prevent clotting of the lumen. In an example, the stopper300acan connect to a protective cap410at the stopper connector310in order to cover the fixed stylet302when not in use according to an example (SeeFIG. 4A). In an example, the stopper300b-ccan have a protective cap420connected at the hub340,350with or without the anti-coagulant agent402for covering and coating respectfully, the sliding stylet304or the ribbed stylet306when not in use according to an example (SeeFIG. 4B). In an example, the hub360of the coiling retractor362can serve as a protective cap430and include the anti-coagulant agent402for coating the coiling stylet308when the coiling stylet308is retracted according to an example (SeeFIG. 4C).

FIGS. 5A-Bshow pictures of the stopper110used with an IV catheter510having a two-way connector according to some implementations. In an example, the IV catheter510can have a first connector512and a second connector514. In an example, the IV catheter510can extend (FIG. 5A) and retract (FIG. 5B) the stylet112from a lumen of the first connector512, while an IV therapy is administered from the second connector514. The second connector could also be polluted with the anti-coagulant agent402onto the stylet112as it is being extended or retracted. Accordingly, the location of the second connector514provides distinct advantages of being able to directly provide IV therapy at a point of entry.

Stylet and Catheter Complementary Features

FIG. 6Ashows a cross-section along a width of a stylet620awithin a lumen612of a cannula610aaccording to an example. The stylet620ais shown having complementary cylindrical shape with the lumen612of the cannula610a. In some implementations, the stylet112and/or the cannula122can have complementary features configured to prevent the stylet112from being entirely removed from the cannula122when the stylet112is retracted, as well as to facilitate alignment the stylet112with the lumen of the cannula122when the stylet112is fully retracted from the cannula122.

FIG. 6Bshows a cross-section along a width of a stylet620band a cannula610bwhich form a tongue and groove complementary feature630according to an example. The tongue and groove complementary feature630can allow for alignment of the stylet620binto the cannula610bby aligning a groove622in the stylet620bwith a tongue614of the cannula610b. In an example, the groove622can have a lip624and the tongue614can include a head616configured to catch and to guide the stylet620b. In some implementations, the complementary feature630can be configured with the stylet620bwithin the stopper110. In some implementations, the stylet620bcan be configured with the groove and the cannula610bcan be configured with the tongue.FIG. 6Cshows a cross-section along a length of a stylet620cand a cannula610cwhich form a head and socket complementary feature640according to an example. The head and socket complementary feature640can include a flush stylet head626configured to be caught in an indented wall618of a cannula610c. In an example, the flush stylet head626of the distal portion of the stylet620cis wider than the indented wall618of the cannula610csuch that the stylet620cis prevented from being fully removed from the cannula610cwhile also allowing the lumen of the cannula610cto be unobstructed.

Advantages

As shown inFIG. 7, the stylet112can be retracted from the lumen of the cannula122and a needle712of a syringe710can be introduced into the lumen of the cannula122in order to administer the IV therapy. In an example, the flashback chamber130formed by connecting the stopper110and the catheter120can have a width to house both the stylet112and the needle712. In an example, the flashback chamber130can be transparent to aid the user in aligning the needle712to the lumen of the cannula122. Importantly, the IV therapy can be administered without disconnection of the stopper110from the catheter120.