Vascular access device stagnant fluid displacement

A medical device may include an extravascular system, a vascular access device attached to the system, and at least one access port attached to the device capable of displacing stagnant fluid within the extravascular system. A method for eliminating stagnant fluid within an extravascular system may include providing an extravascular system, providing a vascular access device having an access port, attaching the device to the system via the access port, accessing the access port with a separate vascular access device, and displacing stagnant fluid within the extravascular system.

BACKGROUND OF THE INVENTION

The present disclosure relates to the elimination of stagnant flow in extravascular systems used to provide infusion or other therapy to patients. Infusion therapy is one of the most common health care procedures. Hospitalized and home care patients receive fluids, pharmaceuticals, and blood products via a vascular access device inserted into the vascular system. Infusion therapy may be used to treat an infection, provide anesthesia or analgesia, provide nutritional support, treat cancerous growths, maintain blood pressure and heart rhythm, or many other clinically significant uses.

Infusion therapy is facilitated by vascular access devices located outside the vascular system of a patient. An extravascular system includes least one vascular access device and/or other medical device that may access a patient's peripheral or central vasculature, either directly or indirectly. Vascular access devices include closed access devices, such as the BD Q-SYTE™ closed Luer access device of Becton, Dickinson and Company; syringes; split access devices; catheters; and intravenous (IV) fluid chambers. An extravascular system may access a patient's vascular system for a short term (days), a moderate term (weeks), or a long term (months to years), and may be used for continuous infusion therapy or for intermittent therapy.

Complications associated with infusion therapy include significant morbidity and even mortality. Such complications may be caused by regions of stagnant flow within the vascular access device or nearby areas of the extravascular system. These are regions in which the flow of fluid is limited or non-existent due to the conformation of the extravascular system or the fluid dynamics within that area of the extravascular system. Air bubbles or infused medications may become trapped within these regions of stagnant flow as a result of the limited or non-existent fluid flow. When a different medication is infused into the extravascular system, or the extravascular system is exposed to physical trauma, the extravascular system's fluid flow may become altered, releasing trapped air bubbles or residual medications back into the active fluid path of the extravascular system. This release of air bubbles and residual medication into the active fluid path extravascular system may result in significant complications.

Released air bubbles may block fluid flow through the extravascular system and prevent its proper functioning. More seriously, released air bubbles may enter the vascular system of the patient and block blood flow, causing tissue damage and even stroke. In addition, residual medications may interact with presently infused medications to cause precipitates within the extravascular system and prevent its proper functioning. Furthermore, residual medications may enter the vascular system of the patient and cause unintended and/or undesired effects.

Therefore, a need exists for systems and methods that eliminate, prevent, or limit regions of stagnant flow within vascular access devices and extravascular systems.

BRIEF SUMMARY OF THE INVENTION

The present invention has been developed in response to problems and needs in the art that have not yet been fully resolved by currently available extravascular systems, devices, and methods. Thus, these developed systems, devices, and methods provide an extravascular system that may be connected to a patient's vascular system and will eliminate, prevent, or limit regions of stagnant flow within the vascular access device or the extravascular system.

A medical device for eliminating stagnant fluid within an extravascular system may include an extravascular system, a vascular access device attached to the extravascular system, and at least one access port attached to the vascular access device. The access port may displace stagnant fluid within the extravascular system. The access port may include a cam valve. The cam valve may be spring-loaded. The cam valve may open upon access of the access port, causing the cam valve to receive fluid. The cam valve may close upon removal of a separate vascular access device from the access port, causing the cam valve to expel fluid.

The medical device may also include an active fluid path within the extravascular system. The access port may be in direct contact with the active fluid path. The medical device may also include an extensible housing of the extravascular system, and the access port may be secured to the extensible housing. The extensible housing may be elastic. The medical device may also include a positive stop within the active fluid path of the extravascular system and opposite the access port. The extensible housing may extend when a separate vascular access device accesses the access port and exerts force against the positive stop.

The access port may be at an obtuse angle in relation to the fluid path downstream from the access port. The access port may include a septum having a convex bottom surface in contact with the active fluid path.

A method for eliminating stagnant fluid within an extravascular system may include providing an extravascular system, providing a vascular access device having an access port, attaching the vascular access device to the extravascular system via the access port, accessing the access port with a separate vascular access device, and displacing stagnant fluid within the extravascular system. The access port may include a cam valve and the method may further include opening the cam valve. The method may further include closing the cam valve.

The extravascular system may include an active fluid path and the method may include placing the access port in direct contact with the active fluid path. The extravascular system may include an extensible housing and the method may include attaching the access port to the extensible housing and, upon accessing the access port, extending the extensible housing.

Attaching the vascular access device to the extravascular system may include setting the access port at an angle that is obtuse from the fluid path downstream of the access port. The method may include adding material to the access port to replace space where the stagnant fluid would reside within the extravascular system absent the added material.

A medical device may include a means for accessing the vascular system of a patient and a means for displacing stagnant fluid. The means for displacing stagnant fluid may reside within the means for accessing the vascular system of the patient.

These and other features and advantages of the present invention may be incorporated into certain embodiments of the invention and will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter. The present invention does not require that all the advantageous features and all the advantages described herein be incorporated into every embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The presently preferred embodiments of the present invention will be best understood by reference to the drawings, wherein like reference numbers indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of presently preferred embodiments of the invention.

Referring now toFIG. 1, a vascular access device10is used to introduce a substance along a fluid path via a catheter12across the skin14and into a blood vessel16of a patient18. The vascular access device10includes a body20and an access port22. The access port22has a slit septum24through which a separate vascular access device26having a tip30, such as a syringe, may introduce a substance into the vascular access device10. The vascular access device10(also referred to as an extravascular device, intravenous access device, and/or any device attached to or functioning with an extravascular system) and the separate vascular access device26form at least part of an extravascular system28. The vascular access device10may be secured to an adapter, a catheter12, or any other extravascular device at any attachment location and in any attachment orientation.

Referring now toFIG. 2, a partial cross section view of a vascular access device10and a separate vascular access device26of an extravascular system28shows the tip30of the separate vascular access device26being inserted into the access port22of the vascular access device10. The access port22includes two separable halves32, each independently secured to an inner wall34of the device10by means of separate compression springs36. The two halves32, under the compression of the springs36form a spring-loaded cam valve.

Each of the spring-loaded halves32includes a tapered inner surface40capable of communicating with an outer surface of the tip30such that the tip30causes the two halves32to separate as the tip30is advanced into the access port22and against the two tapered surfaces40. Thus, the cam valve of the access port22opens as the access port22is accessed by a separate vascular access device26. As the cam valve opens, a fluid path42opens and widens between the two halves32.

Referring now toFIG. 3, a partial cross section view of the embodiment described with reference toFIG. 2is shown. As shown inFIG. 3, the tip30is fully advanced into the access port22and against the tapered inner surfaces40, causing the two halves32to be compressed against their respective springs36, and causing the fluid path42to be opened to its maximum width.

Referring now toFIG. 4, the embodiment described with reference toFIGS. 2 and 3is shown with the tip30of the separate vascular access device26removed from the access port22. With the tip30removed from the access port22, the compression springs36have forced the separate halves32to come into contact with each other, eliminating or closing the fluid path42.

Referring now toFIGS. 5 through 8, a possible valve geometry of the cam valve described with reference toFIGS. 2 through 4is shown and described. Referring first toFIG. 5, the cam valve of the access port22includes the two halves32in contact with each other. Referring now toFIG. 6, when the cam valve of the access port22is open, the separate halves32are separated from and not in contact with each other. In addition to the tapered inner surfaces40of the halves32, the halves32include another tapered surface44on the interior surfaces of the halves32. The other tapered surfaces44taper in a direction opposite the tapered surfaces40. The material of the halves32may be pliable, such that the material may be compressed as the other tapered surfaces44come into contact with each other.

Referring now toFIG. 7, the cam valve of the access port22is shown, beginning to close. The other inner surfaces44of the two halves32have begun to come into contact with each other. As the other tapered inner surfaces44come into contact with each other, the external environment46in which the extravascular system is placed is isolated from the fluid path42of the system28. As the other tapered inner surfaces44isolate the external environment46from the fluid path42, the fluid within the fluid path42may not exit the fluid path42towards the external environment46.

Referring now toFIG. 8, the cam valve of the access port22described with reference toFIGS. 5 through 7is shown with the two halves32further compressing towards one another. As the two halves32compress the material of each of the two halves32and come into further contact with each other, the other tapered inner surfaces44come into progressive contact with each other, forcing fluid within the fluid path42in a direction48away from the external environment46and into the extravascular system28. Thus, the tapered inner surfaces44of the compressible halves32enable the cam valve to close upon removal of a separate vascular access device26from the access port22, simultaneously causing the cam valve to expel fluid. The cam driven valve also advantageously eliminates space that would otherwise harbor stagnant fluid adjacent to the access port22.

Referring now toFIG. 9, an extravascular system28may include a vascular access device10attached to the extravascular system28and at least one access port22attached to the vascular access device10. The access port22is in direct contact with the active fluid path50of the extravascular system28. The access port22includes a septum52having a bottom disc54in contact with the active fluid path50. The bottom disc54opens into the active fluid path50when the access port22is accessed by a separate vascular access device26. However, since the length of the two halves32of the bottom disc54of the septum52is longer than the diameter of the active fluid path50, the bottom disc54of the septum52may not fully open during access. Thus, an alternate embodiment, providing full access yet direct proximity or contact to the active fluid path50, may be preferred and is described with reference toFIGS. 10 and 11.

Referring now toFIG. 10, an extravascular system28may include a separate vascular access device26secured to a vascular access device10, which is in turn secured to a portion of the extravascular system having an extensible housing56. The extensible housing56may be formed of elastic or other material capable of extending away from the active fluid path50of the system28. The access port22of the device10is secured to the extensible housing56.

The extravascular system28may also include a positive stop58within the active fluid path50of the extravascular system28and opposite the access port22. When the tip30of a separate access device26is inserted into the access port22, the tip30will ultimately come into contact with the positive stop58. When the tip30comes into contact with and exerts force against the positive stop58, the access port22may extend away from the active fluid path50by extending the extensible housing56. The extensible housing56draws the access port22towards the tip30of the separate vascular access device26and extends when the separate vascular access device26accesses the access port22and exerts force against the positive stop58.

The embodiment described with reference toFIG. 10thus provides an extensible housing56that enables an access port22to be in direct contact with the active fluid path50of the system28. In addition, the extensible housing56and positive stop58enable the tip30of a separate vascular access device26to be fully inserted and to be able to fully infuse into and operate within the active fluid path50. Thus, the embodiment described with reference toFIG. 10solves the limitations that exist in relation to the embodiment described with reference toFIG. 9.

Referring now toFIG. 11, an extravascular system28includes a separate vascular access device26inserted into a vascular access device10which is in turn connected or attached to a remaining portion of the extravascular system28having an active fluid path50. The vascular access device10includes an access port22. The access port22is in direct contact with the active fluid path50. The access port22is at an angle that is obtuse, between 90 degrees and 180 degrees, in relation to the fluid path50that is downstream60from the access port22. Thus, the embodiment described with reference toFIG. 11enables the tip30of a separate access device26to be fully inserted at an obtuse angle into the access port22of the device10and into the active fluid path50of the system28. When fully inserted, the tip30may function properly and fully infuse fluids into the active fluid path50. Simultaneously, the bottom surface of the access port22is in direct contact with the active fluid path50, eliminating or otherwise limiting any stagnant fluid that would otherwise exist between the active fluid path50and an access port22that was not in direct contact with the active fluid path50.

The embodiments described with reference toFIGS. 9 through 11thus provide access ports22in direct contact with the active fluid path50of an extravascular system28. The embodiments described with reference toFIGS. 10 and 11further provide access ports22capable of fully accepting the tips30of separate access devices26into the active fluid path50. In addition, the embodiments described with reference toFIGS. 10 and 11provide access ports22capable of displacing fluid into the active fluid path50as the separate vascular access devices26are removed from the access ports22.

Referring now toFIG. 12, a traditional access port22of an extravascular system28includes a septum52with a concave bottom surface on the bottom disc54of the septum52. The concave shape of the bottom surface of the bottom disc54provides an area of dead space62directly beneath the septum52where stagnant fluid may reside. Thus, an embodiment eliminating the dead space62may be preferred and will be described with reference toFIG. 13.

Referring now toFIG. 13, an extravascular system28may include an access port22having a septum52with a convex bottom surface64in contact with the active fluid path50of the system28. The convex bottom surface64protrudes into a space where dead space62is likely to harbor stagnant fluid. When the access port22is accessed by the tip30of a separate access device26, the convex bottom surface64will open, protruding into the dead space62where the stagnant fluid resided prior to access. Thus, the embodiment described with reference toFIG. 13provides an access port22with a convex bottom surface capable of eliminating or otherwise displacing dead space62where stagnant fluid may reside. The access ports22may reside closer to or more distant from the active fluid path50.

Any of the features and elements described with reference toFIGS. 1 through 13may be used in any combination and number in order to provide at least one access port capable of displacing, eliminating, limiting, or otherwise interacting with stagnant fluid within an extravascular system28.

FIGS. 14 and 15illustrate the solution of a similar problem.FIG. 14illustrates an access port22which may result in a dead space62. As illustrated inFIG. 15, the dead space62is filled by two downward projections64. Thus, the dead space62is occupied and will not result in the problems discussed above.