The present invention is directed to an angiocatheter device, more particular to an angiocatheter that utilizes a fluid retention component configured to stop any blood spill or leakage as the catheter is installed on the patient and connected to an intravenous (IV) line or other device. The present invention can also utilize needle safety mechanisms and enables freedom of the care providers hand normally occupied with stopping the blood flow out of the catheter.
Angiocatheters are devices that are inserted into a patient's vein for intravenous (IV) access for fluids and medications and in some cases obtain blood samples. Usually an angiocatheter is inserted by using the needle, which is positioned within the lumen of the cannula. When the needle penetrates the vessel, the blood pressure in the vessel will cause blood to flow up the needle bore and into translucent tubing around the top of the angiocatheter. The practitioner verifies the penetration of the vessel by looking for blood “flash” in the chamber. The cannula of the angiocatheter is then advanced within the blood vessel to a desired position and the needle is withdrawn from the cannula.
Sometimes when the needle is withdrawn and the practitioner attempts to introduce either IV tubing or a blood sampling device, blood may flow from the catheter, which may cause a pathogen exposure. This process for the practitioner can be difficult, since generally the practitioner must use one hand (once the catheter is installed) to press on the vein ahead of the inserted catheter to stop blood flow out of the catheter, thereby allowing the practitioner only one hand to unwrap and install a saline lock or IV line into the open end of the catheter from which blood can escape. This poses a risk and increases the chance that the practitioner is exposed to the patient's blood.
Current models of catheters and the catheters described herein may be manufactured in many ways but are typically injection molded out of polyethylene or other biologically safe thermoplastics well known in the art. The catheters may also be made of semi transparent, transparent or clear materials either in whole or in a portion of the catheter to allow the observation of the blood flash through the body of the catheter. Typically the soft or flexible cannula has a material embedded in it to make it visible via radiograph during or after insertion into the patient. These materials and methods to manufacture and embed in the cannula are well known in the art.
The present invention features a novel angiocatheter device that helps protect the practitioner, patient and equipment from unnecessary exposure and contamination. For example, the angiocatheter device of the present invention helps to stop the chance of a blood splash or leak that could possibly risk and expose the healthcare provider or patient to pathogens and diseases such as hepatitis or human immunodeficiency virus (HIV). Such a device can help provide a much safer work environment for healthcare providers and technicians.
Any feature or combination of features described herein are included within the scope of the present invention provided that the features included in any such combination are not mutually inconsistent as will be apparent from the context, this specification, and the knowledge of one of ordinary skill in the art. Additional advantages and aspects of the present invention are apparent in the following detailed description and claims.
The present invention features novel angiocatheter devices for helping to protect a practitioner, a patient, and equipment from exposure and contamination. In some embodiments, the device comprises a catheter body having a first end, a second end, and an inner cavity, the second end being open providing access to the inner cavity of the catheter body; a stationary anchor disposed in the inner cavity of the catheter body, a first end of the stationary anchor facing the first end of the catheter body and a second end of the stationary anchor facing the second end of the catheter body; a channel having a first end and a second end, the first end being positioned at the first end of the catheter body and the second end being positioned at the second end of the stationary anchor, the channel fluidly connects the first end of the catheter body and the second end of the stationary anchor; and a compressible valve, a first end of the compressible valve surrounds at least a portion of the stationary anchor and a second end faces the second end of the catheter body, a hole is disposed in the second end of the compressible valve.
The compressible valve can move between at least an extended position and a compressed position, wherein in the extended position the second end of the compressible valve is positioned closer to the second end of the catheter body than is the second end of the stationary anchor and the hole in the second end of the compressible valve is closed preventing fluid transfer from the channel into the catheter body, wherein in the compressed position the compressible valve is compressed such that the second end of the stationary anchor is closer to the second end of the catheter body than is the second end of the compressible valve and the hole is the second end of the compressible valve is open allowing fluid access to the second end of the channel and second end of the stationary anchor for fluid transfer, the compressible valve is biased in the extended position.
In some embodiments, the angiocatheter device further comprises a cannula disposed on the first end of the catheter body and fluidly connected to the channel. In some embodiments, the angiocatheter device further comprises a removable needle housed within the cannula. In some embodiments, the angiocatheter device further comprises a needle stick safety device engaged with the needle, the needle stick safety device is removed from device if the needle is removed.
In some embodiments, the angiocatheter device further comprises a lip disposed around the second end of the catheter body. In some embodiments, the angiocatheter device further comprises stabilizing tabs disposed on and protruding from sides of the catheter body.
In some embodiments, the catheter body is generally cone-shaped with the first end having a diameter smaller than that of the second end. In some embodiments, the catheter body is generally cylindrical in shape. In some embodiments, the angiocatheter device further comprises a window disposed in the catheter body. In some embodiments, the window is constructed from a translucent, transparent, or clear material. In some embodiments, the stationary anchor is generally cone-shaped with the second end having a diameter smaller than that of the first end. In some embodiments, the compressible valve is constructed from a material comprising a silicone, a rubber, a foam, or any flexible, compressible medical grade material that can be utilized as the compressible valve.
In some embodiments, the first end of the compressible valve is mounted around the stationary anchor via a mounting component. In some embodiments the mounting component for the compressible valve is a second, third or fourth component that slides into the catheter body after the catheter cannula and stationary anchor are assembled into the catheter. In some embodiments, the angiocatheter device further comprises a cover adapted to temporarily cover the second end of the hub. In some embodiments, the cover is attached to the catheter body via an attachment means. In some embodiments, the angiocatheter device further comprises a saline lock attached to the catheter body via an attachment means.
In some embodiments, the angiocatheter device comprises a catheter body having a first end, a second end, and a hub disposed on the second end of the catheter body, the connection hub has an open second end; a valve disposed in the hub of the catheter body; and a channel, the channel extending from the valve to at least the first end of the catheter body. The valve can move between an open position and a closed position and is biased in the closed position, wherein when a needle or a medical fitting is introduced into the hub of the catheter body via the open second end of the hub and makes contact with the valve the valve moves to the open position allowing fluid to transfer between the channel and the needle or medical fitting, and when the needle or medical fitting is removed from the valve the valve moves to the closed position preventing flow of fluid from channel into the catheter body.
In some embodiments, the valve is a reed-type valve, a tines valve, a clapper-type valve, a ball-type valve, a self-sealing membrane valve, a septum valve, a compressible valve, or a combination thereof. In some embodiments, the septum valve is constructed from but not limited to a material comprising a silicone, a rubber, a foam, or combinations of these. The septum may be made of any compressible material that is biocompatible and can be sterilized as well as approved for medical use.
In some embodiments, the angiocatheter device further comprises a cannula disposed on the first end of the catheter body and fluidly connected to the channel. In some embodiments, the angiocatheter device further comprises a removable needle housed within the cannula. In some embodiments, the angiocatheter device further comprises a needle stick safety device engaged with the needle, the needle stick safety device is removed from device if the needle is removed.
In some embodiments, the angiocatheter device further comprises stabilizing tabs disposed on and protruding from sides of the catheter body. In some embodiments, the angiocatheter device further comprises a window disposed in the catheter body. In some embodiments, the angiocatheter device further comprises a cover adapted to temporarily cover the second end of the hub. In some embodiments, the cover is attached to the catheter body via an attachment means. In some embodiments, the angiocatheter device further comprises a saline lock attached to the catheter body via an attachment means.
In the following detailed description of the preferred embodiments, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “upper”, “lower”, “side”, “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figures being described. Because components of the present invention can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense.
Details in the various embodiments such as how the catheters are molded of plastic and joined together via glue or RF welding or assembled with lumen cannula over the needle and how the needle is inserted into the plastic injection molded body of the catheter are all well known in the art.
The term “valve” refers to and includes all types of valves that could be incorporated into the catheter housing to stop the flow of blood back out of the catheters exposed end. Samples of these are spring-loaded clapper valves, spring-loaded ball valves, constant tension activated valves, reed valves, pierceable membranes, self-sealing membranes, compressible septum valves such as those used to seal vials. These are non-limiting examples of various valves or liquid containment mechanisms that would allow repeated access to a patient's blood without allowing the blood to spill or flow back out of the catheter unless desired. These various examples including those that are generally well known in the art are not meant to limit the scope of the invention in any way.
The term needle stick safety device, refers to any component, mechanism or attachment to the catheter designed to prevent accidental needle sticks once the needle is pulled out of or removed from the catheter, there are many examples of these that are well known in the art.
The cannula refers to the sheath or tubing portion of the catheter that covers the needle and is left in the vein once the needle is removed. The cannula is attached to the housing or body of the catheter even when the needle is removed or pulled out of the catheter. The cannula may be constructed from a material comprising a biocompatible flexible plastic or polymer tubing that is well known in the art, however the cannula is not limited to these materials.
Referring now to
As shown in
In some embodiments, a stationary anchor 130 is disposed in the inner cavity of the catheter body 110. The stationary anchor 130 has a first end and a second end 132. In some embodiments, the stationary anchor 130 is generally cone shaped with the second end 132 being the end with the smaller diameter. The stationary anchor 130 is not limited to being cone shaped, for example the stationary anchor 130 may be generally cylindrical in shape or irregular in shape, or the like. The first end of the stationary anchor 130 may be mounted at or near the first end 111 of the catheter body 110 (e.g., see
In some embodiments, a channel 120 is disposed in the stationary anchor 130, wherein the first end 121 of the channel 120 is positioned at the first end 111 of the cannula body 110 and the second end 122 of the channel 120 is positioned at the second end 132 of the stationary anchor 130 (see
Mounted to the stationary anchor 130 is a compressible valve 150. The compressible valve 150 has a first end and a second end 152. In some embodiments, the compressible valve 150 is generally cone shaped, wherein the first end is the end with the smaller diameter. The compressible valve 150 is not limited to being cone shaped, for example the compressible valve 150 may be generally cylindrical in shape or irregular in shape, or the like. The first end of the compressible valve 150 may be mounted around the stationary anchor 130 (e.g., via a mounting component 158) at or near the first end or middle portion of the stationary anchor 130. In some embodiments, an indentation is disposed in the first end of the compressible valve 150 adapted to accept the second end 132 of the stationary anchor 130 (e.g., the compressible valve 150 fits over the second end 132 of the stationary anchor 130). A slit or tiny hole 156 is disposed in the second end 152 of the compressible valve 150.
The compressible valve 150 can be compressed, thus the compressible valve 150 can move between multiple positions including an extended position and a compressed position, wherein the compressible valve 150 is biased in the extended position caused by the material of the compressible valve 150. In the extended position, as shown in
The compressible valve 150 is constructed from a material comprising a compressible material, for example a silicone, a rubber, a thick or dense foam, a foam-like rubber material, or the like. Other materials may include polymers such as polyethylene blends, silicone co-polymers, block polymers or other elastic compressible materials that can be sterilized and are biocompatible or approved for medical use.
In some embodiments, a window (e.g., a blood flash window) (shown in
In some embodiments, stabilizing tabs (shown in
As shown in
A channel 12a is disposed in the catheter body 10, which can be fluidly connected to the cannula 11. The cannula 11 (e.g., the component inserted/anchored into the patient's vessel, may be constructed from a biologically compatible plastic material. The cannula 11 may be attached to the first end of the catheter body (e.g., via a welding, molding or gluing process, etc.) and be fluidly connected to the channel 12a (the channel 12a extends into the inner cavity of the catheter body 10/hub 14).
The device further comprises a connection hub 14 (having a first end and a second end 15), which may be a molded part of the catheter body 10 (e.g.,
In some embodiments, stabilizing tabs 12 are disposed on and protrude from the sides of the catheter body 10. The stabilizing tabs 12 can help prevent turning or twisting of the device once the device is inserted and secured in the patient.
The embodiment shown in
The embodiments shown in
The embodiment shown in
The embodiment shown in
The embodiment shown in
The septum valve may be constructed from a material comprising a biologically safe elastomeric material or combinations of materials such as, but not restricted to, silicone, rubber or polyurethane so that the material returns to its original shape after it is compressed over the stationary anchor 69 and then released or allowed to relax (e.g., once a syringe, luer lock type device, or other medical connection is removed thus allowing needle-less access or fluid connectivity to the catheter and patient using standard medical devices, such as but not limited to, a needle-less syringe or IV tubing connections).
Various modifications of the invention, in addition to those described herein, will be apparent to those skilled in the art from the foregoing description. Such modifications are also intended to fall within the scope of the appended claims. Each reference cited in the present application is incorporated herein by reference in its entirety.
Although there has been shown and described the preferred embodiment of the present invention, it will be readily apparent to those skilled in the an that modifications may be made thereto which do not exceed the scope of the appended claims. Therefore, the scope of the invention is only to be limited by the following claims.
The reference numbers recited in the below claims are solely for ease of examination of this patent application, and are exemplary, and are not intended in any way to limit the scope of the claims to the particular features having the corresponding reference numbers in the drawings.
This application claims priority to U.S. provisional application Ser. No. 61/337,155 filed Feb. 1, 2010 and U.S. provisional application Ser. No. 61/406,016 filed Oct. 22, 2010, the specification of which is incorporated herein by reference in its entirety.
Number | Date | Country | |
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61337155 | Feb 2010 | US | |
61406016 | Oct 2010 | US |