Patent Grant
9138572
The invention generally relates to medical valves and, more particularly, the invention relates to controlling fluid volumes within medical valves.
In general terms, medical valving devices often act as a sealed port that may be repeatedly accessed to non-invasively inject fluid into (or withdraw fluid from) a patient's vasculature. Consequently, a medical valve permits the patient's vasculature to be freely accessed without requiring such patient's skin be repeatedly pierced by a needle.
Medical personnel insert a medical instrument into the medical valve to inject fluid into (or withdraw fluid from) a patient who has an appropriately secured medical valve. Once inserted, fluid may be freely injected into or withdrawn from the patient. Problems can arise, however, when the medical instrument is withdrawn from the valve. Specifically, suction produced by the withdrawing medical instrument can undesirably cause blood to be drawn proximally into or toward the valve. In addition to coagulating and impeding the mechanical operation of the valve, blood in the valve also compromises the sterility of the valve.
In accordance with one embodiment of the present invention, a medical valve may have an open mode that permits fluid flow, and a closed mode that prevents fluid flow. The medical valve may include a housing with an inlet and an outlet, and a resilient member within the housing. The resilient member may have a body portion with a free state when undeformed by external mechanical forces, and a deformed state when the valve is in the closed mode. The body portion may be formed to radially expand to return toward the free state as the valve transitions from the closed mode to the open mode. The body portion may also define at least part of a fluid path through the valve. In some embodiments, the body portion and housing may be configured to permit the body portion to attain the free state when in the open mode. The body portion may be molded in the free state and/or may be normally biased radially outwardly in the closed mode.
In further embodiments, the resilient member may also include a proximal seal portion having a normally closed aperture therethrough. The body portion may be distal to the proximal seal portion, and may have a distal aperture through it that is biased toward an open state. The distal aperture may be closed when in the deformed state to prevent fluid flow through the valve. In some embodiments, the distal aperture may be molded open.
In still further embodiments, the valve may also include a control member that is located within the housing and contains (at least in part) the body portion (e.g., the body portion may be located within the control member). The control member may radially expand after insertion of a medical implement into the inlet, which, in turn, causes the valve to transition from the closed mode to the open mode and allows the body portion to return toward the free state. The control member may include a plurality of leg members that radially deform to expand the control member (e.g., as the valve transitions toward the open mode). The deformation of the leg members also allows the body portion to return towards the free state. 21. The leg members may bias the valve toward the closed mode. The control member may also include a biasing member (e.g., a leaf spring) that biases the valve toward to closed mode. The valve may have a substantially neutral fluid displacement at the outlet as the valve transitions from the open mode to the closed mode.
In accordance with additional embodiments, a medical valve may have an open mode that permits fluid flow, and a closed mode that prevents fluid flow. The medical valve may include a housing with an inlet and an outlet. The medical valve may also include a resilient member within the housing. The resilient member may have a proximal aperture and a distal aperture biased toward an open state to allow fluid flow through the valve when in the open mode. The resilient member may be deformed when the valve is in the closed mode to close distal aperture and prevent fluid flow through the valve. The distal aperture may return toward its open state as the valve transitions from the closed to open mode.
In some embodiments, the distal aperture may be formed to be in the open state when no radial force is applied to the resilient member. In other embodiments, the distal aperture may be molded in the open state. The distal aperture may be normally biased radially outward in the closed mode.
In additional embodiments, the medical valve may also include a control member that deforms the resilient member to close the distal aperture and prevent fluid flow through the valve when the valve is in the closed mode. The control member may radially expand as the valve transitions to the open mode to allow the distal aperture to return toward its open state, and allow fluid flow through the valve. The control member may include a plurality of leg members that radially deform to expand the control member as the valve transitions toward the open mode. The leg members may bias the valve toward the closed mode. The control member may also include a biasing member (e.g., a leaf spring) that biases the valve toward to closed mode.
In some embodiments, the resilient member may include a body portion and a proximal seal portion. The body portion has a free state when undeformed by external mechanical forces, and a deformed state when the valve is in the closed mode. The body portion may be formed to return toward the free state as the valve transitions from the closed mode to the open mode. The body portion may define at least part of a fluid path through the valve, and may be distal to the proximal seal portion. The distal aperture may be located within the body portion and the proximal aperture may be located within the proximal seal portion.
In further embodiments, the body portion may have an outer dimension that is at its natural dimension when in the free state. The control member may deform the body portion such that the outer dimension expands past the natural dimension when the valve is in the open mode.
In accordance with additional embodiments, a method may include connecting a medical valve to a patient, inserting a medical implement through a valve inlet, moving the medical implement distally within the housing to transition the valve from a closed mode to an open mode, and transferring fluid between the medical implement and the patient through the valve. The medical valve may include a housing having the inlet and an outlet, a resilient member, and a control member. The resilient member may be within the housing and have a proximal aperture and a distal aperture biased toward an open state. The control member may deform the resilient member to close the distal aperture when the valve is in a closed mode. Distal movement of the medical implement may cause the control member to expand generally radially to allow the distal aperture to return toward the open state.
The distal aperture may be formed to be in the open state when no radial force is applied to the resilient member and/or may be normally biased radially outward in the closed mode. The control member may also include a plurality of leg members that radially deform to expand the control member as the valve transitions toward the open mode. Additionally, the control member may include a biasing member that biases the valve toward to closed mode.
In accordance with further embodiments, a resilient member for a medical valve having a housing with an inlet and an outlet may include a proximal seal portion and a body portion. The body portion may be distal to the proximal seal portion and have a free/at-rest state when the valve is in the open mode. The body portion may also have a compressed state when the valve is in the closed mode. The body portion may be molded in the free/at-rest state and return to the at-rest state as the valve transitions from the closed mode to the open mode.
The foregoing features of the invention will be more readily understood by reference to the following detailed description, taken with reference to the accompanying drawings, in which:
In illustrative embodiments, a medical valve has an internal valve mechanism with a resilient member having a normally open distal aperture. The medical valve may also have a control member that compresses the resilient member to close the distal aperture when the valve is in the closed mode. Other embodiments of a medical valve have an internal resilient member with a normally outwardly biased body portion. Actuation of this valve urges the resilient member toward its free state. Details of illustrative embodiments are discussed below.
After the valve 10 is in place, a nurse, doctor, technician, practitioner, or other user (schematically identified by reference number 20) may intravenously deliver medication to the patient 30, who is lying in a hospital bed. To that end, before the valve 10 is properly primed and flushed (e.g., with a saline flush), the nurse 20 swabs the top surface of the valve 10 to remove contaminants. Next, the nurse 20, once again, swabs the top surface of the valve 10 and uses a medical instrument 40 (e.g., a syringe having a distally located blunt, luer tip complying with ANSI/ISO standards) to inject medication into the patient 30 through the valve 10. For example, the medical practitioner 20 may use the valve 10 to inject drugs such as heparin, antibiotic, pain medication, other intravenous medication, or other fluid deemed medically appropriate. Alternatively, the nurse 20 (or other user) may withdraw blood from the patient 30 through the valve 10.
The medical valve 10 may receive medication or other fluids from other means, such as through a gravity feed system 45. In general, traditional gravity feeding systems 45 often have a bag 50 (or bottle) containing a fluid (e.g., anesthesia medication) to be introduced into the patient 30. The bag 50 (or bottle) typically hangs from a pole 47 to allow for gravity feeding. The medical practitioner 20 then connects the bag/bottle 50 to the medical valve 10 using tubing 60 having an attached blunt tip. In illustrative embodiments, the blunt tip of the tubing has a luer taper that complies with the ANSI/ISO standard.
After the tubing 60 is connected to the medical valve 10, gravity (or a pump) causes the fluid to begin flowing into the patient 30. In some embodiments, the feeding system 45 may include additional shut-off valves on the tubing 60 (e.g., stop-cock valves or clamps) to stop fluid flow without having to disconnect the tubing 60 from the valve 10. Accordingly, the valve 10 can be used in long-term “indwell” procedures.
After administering or withdrawing fluid from the patient 30, the nurse 20 should appropriately swab and flush the valve 10 and catheter 70 to remove contaminants and ensure proper operation. As known by those skilled in the art, there is a generally accepted valve swabbing and flushing protocol that should mitigate the likelihood of infection. Among other things, as summarized above, this protocol requires proper flushing and swabbing before and after the valve 10 is used to deliver fluid to, or withdraw fluid from the patient 30.
In this context, fluid displacement generally refers to the flow of fluid through the distal port 120 of the valve 10 (discussed below). Accordingly, a positive fluid displacement generally refers to fluid flowing in a distal direction through the distal port 120, while a negative fluid displacement generally refers to a fluid flowing in a proximal direction through the distal port 120. Of course, not all embodiments exhibit this quality. For example, in alternative embodiments, the valve 10 may have a neutral fluid displacement when the instrument 40 is withdrawn.
It should be noted that the fluid displacements discussed herein refer to the “net” fluid displaced through the distal port 120 (i.e., upon insertion or withdrawal of an instrument 40 only-not including when the instrument 40 actually injects fluid through the valve). Specifically, during insertion or withdrawal of the instrument 40, the actual flow of fluid through the distal port 120 may change direction and thus, fluctuate. However, when considering this fluctuation, the net change in fluid flow through the distal port 120 should be 1) positive when the valve exhibits a “positive fluid displacement,” and 2) negative when the valve exhibits a “negative fluid displacement.” In a similar manner, a substantially neutral fluid displacement occurs when, as noted above, the valve 10 has a net fluid displacement of between about plus or minus one microliter. Of course, the fluid displacement of the valve 10 is discussed herein in terms of one stroke of the instrument 40 (i.e., insertion or withdrawal of the instrument 40).
Ideally, a valve with a neutral displacement has 0.0 microliters of positive or negative fluid displacement. As suggested above, however, in practice, a neutral displacement actually can have a very slight positive or negative displacement (e.g., caused by a manufacturing tolerance), such as a displacement on the order of positive or negative one microliter, or less. In other words, in such embodiments, the volumes of fluid forced through the distal port 120 in a neutral displacement valve are negligible (ideally zero microliters) and should have a negligible impact on the goals of the valve.
Some embodiments may have a very low positive or negative fluid displacement upon withdrawal. For example, such valves may have a negative fluid displacement of about one to two microliters (i.e., about one to two microliters of fluid drawback, which is proximally directed), or about one to two microliters positive fluid displacement (i.e., about one to two microliters of positively pushed fluid, which is distally directed). Although such amounts are in the positive or negative fluid displacement ranges, they still should represent a significant improvement over valves that exhibit higher positive or negative fluid displacements upon withdrawal.
The neutral, positive, or negative fluid displacement of a valve may be corrupted by manual handling of the valve 10, catheter 70 or the instrument 40 during the fluid transfer. For example, a slight inward force applied to the shaft of the medical instrument 40 (e.g., by the nurse's hand when simply holding the medical instrument 40) can have the effect of adding a positive fluid displacement from the medical instrument 40 (when the force is applied) and, ultimately, through the valve 10. In fact, releasing this force from the medical instrument 40 actually may draw fluid proximally, causing a negative fluid displacement that further corrupts fluid displacement. These effects, however, should not be considered when determining the nature of fluid displacement through the distal port 120. To overcome the problem noted above with regard to squeezing the medical instrument shaft, for example, the nurse 20 can hold another part of the medical instrument that does not contain the fluid (e.g., stubs at the proximal end of the medical instrument 40).
To accomplish these desired goals, the valve 10 has a housing 100 forming an interior having a proximal port 110 for receiving the instrument 40, and the noted distal port 120 having the discussed fluid displacement properties. The valve 10 has an open mode that permits fluid flow through the valve 10, and a closed mode that prevents fluid flow through the valve 10. To that end, the interior contains a valve mechanism that selectively controls (i.e., allow/permits) fluid flow through the valve 10. The fluid passes through a complete fluid path that extends between the proximal port 110 and the distal port 120.
It should be noted that although much of the discussion herein refers to the proximal port 110 as an inlet, and the distal port 120 as an outlet, the proximal and distal ports 110 and 120 also may be respectively used as outlet and inlet ports. Discussion of these ports in either configuration therefore is for illustrative purposes only.
The valve 10 is considered to provide a low pressure seal at its proximal end 110. To that end, the proximal end 110 of the medical valve 10 has a resilient proximal seal 80 with a resealable aperture 130 that extends entirely through its profile. The aperture 130 may, for example, be a pierced hole or a slit. Alternatively, the proximal seal 80 may be molded with the aperture 130. To help center the proximal seal 80 within the proximal port 110 and keep the aperture 130 closed (e.g., by pre-loading the aperture 130), the proximal gland may have centering ribs 82 nearer the proximal end of the proximal seal 80.
As mentioned above, some embodiments of the present invention may be swabbable. To that end, the proximal seal 80 may be substantially flush with or extend slightly proximal to the proximal port 110 when the valve 10 is in the closed mode. This creates a swabbable surface at the inlet of the valve 10 and allows the nurse 20 to perform the swabbing protocol discussed above.
The internal valve mechanism may include a resilient member 310 at least partly within a control member 340 that cooperate with one another to selectively open and close the valve 10. In the embodiment shown in
As shown in
The body portion 330 is distal to the proximal portion 320 and extends into a wider cavity 102 within the housing 100. The body portion 330 in this embodiment thus may be considered to include a proximal volume 332 and a distal volume 334 separated by a distal seal 336. Like the proximal seal 80, the distal seal 336 may also have a distal aperture 338 extending through it. As discussed in greater detail below, when the valve 10 is in the open mode, the proximal aperture 130 and the distal aperture 338 are open to allow fluid flow to pass through the valve 10.
As shown in
Accordingly, as described in greater detail below, when the valve 10 is in the closed mode, the control member 340 deforms the body portion 330 to close the distal seal aperture 338 (and compress/reduce the outer dimension). Thus, when in the closed mode, the body portion 330 and distal seal aperture 338 are biased radially outward; namely, they normally apply a generally radially outward force that the control member 340 controls. Thus, expansion and contraction of the control member 340 controls the movement of the body portion 330 of the resilient member 310.
Returning to
As discussed above, the control member 340 controls the deformation and compression of the resilient member 310 and substantially deforms the resilient member 310 when the valve 10 is in the closed mode. To that end, the control member 340 should be formed from a material that is more rigid than that of the resilient member 310. However, because the control member 340 must deform to allow the valve 10 to transition between the open and closed modes, the control member material must also be resilient. For example, the control member 340 may be made from a resilient plastic (e.g. soft thermoplastic) that allows the leg members 370 to deform/flex as the valve 10 opens, and return to their at rest state as the valve 10 closes. Alternatively, the control member 340 may be made from a resilient metal (e.g. nitinol) to enable return of the leg members 370 to their at rest state.
Unlike the resilient member 310, the control member 340 is generally in its free/at-rest state (shown in
As discussed above, as the medical valve 10 transitions between the open and closed modes, the leg members 370 may deform and bow outwardly (see
Additionally, to help the control member 340 return to its normal state (e.g., the state shown in
As mentioned above and as illustrated in
Upon further distal movement of the medical instrument 40 into the valve 10, the force of the distal movement of the medical instrument 40 will be translated to the control member 340, which will begin to deform, as described above. For example, the leg members 370 will begin to deform and bow/flex outwardly at the thinned portions 372/373. Additionally, the leaf springs 375 will also begin to deform, as described above.
As mentioned above, the resilient member 310 is formed/molded such that when it is in the free state shown in
As the resilient member 310 begins to return toward the free state, the distal aperture 338, in turn, begins to open to fluidly connect the valve inlet 110 and outlet 120. Once the valve 10 is in the open mode (e.g., after the distal seal aperture 338 is open), the medical practitioner 20 or other user may transfer fluid to and/or from the patient 30. When fluid is transferred to and/or from the patient 30, the fluid passes through a fluid path within the valve 10. As the name suggests, the fluid path is the path the fluid takes as it passes through the valve 10. As shown in
It is important to note that, in some embodiments, the resilient member 310 (e.g., the body portion 330) does not need to fully return to its free/at-rest state for the valve 10 to be in the open mode. Rather, the control member 340 and the resilient member 310 may be configured such that the control member 340 still applies some compressive force on the resilient member 310 when the valve 10 is in the fully open mode. In such embodiments, the distal seal aperture 338 may, or may not fully open and the resilient member 310 may not return to the free/at-rest state shown in
Conversely, in some embodiments, the body portion 330 may be deformed such that the outer dimension extends beyond its natural maximum dimension (e.g., the maximum dimension in the free state) when the valve 10 is in the open mode. In such embodiments, the control member 340 may continue to expand radially outward after the body portion 330 reaches its free state (e.g., if the medical implement 40 is inserted further). The additional radial expansion of the control member 340 will, in turn, apply a longitudinal force on the body portion 330 (e.g., as the length of the control member 340 decreases) and cause the outer dimension of the body portion 330 to expand radially outwardly past its maximum natural dimension.
Upon disconnection and withdrawal of the medical implement 40, the leaf springs 375 and the leg members 370 urge the valve 10 from the open mode shown in
As mentioned above, various embodiments of the present invention may have differing fluid displacements at the outlet 120 upon insertion and withdrawal of the medical implement. For example, the valve 10 may have a positive, negative, or a neutral fluid displacement at the outlet 120 upon withdrawal of the medical implement. To that end, valve designers/engineers may “tune” various embodiments of the valve 10 to achieve the desired fluid displacement. In particular, the fluid displacement at the outlet is dependent upon, among other things, the original state (e.g., the free/at-rest/as-molded state) of the resilient member 310 and the respective sizes of the body portion proximal volume 332 and distal volume 334. Therefore, to create a positive fluid displacement at the outlet 120, the resilient member 310 should be molded such that total volume in the valve 10 when the valve 10 is in the open mode is greater than the total volume when in the closed mode. Alternatively, to create a substantially neutral fluid displacement, the resilient member 310 should be formed/molded such that the total volume when in the closed mode and the open mode are substantially equal.
It is important to note that, although
Additionally, some embodiments of the present invention may not utilize a control member 340 with the leg members 370 described above. In such embodiments, the valve 10 may include a control member 340 with an interrupted wall (not shown). For example, the wall may have interruptions spaced about the diameter of the control member 340 to create alternating areas of wall material and interruptions. Like the embodiments having leg members 370 described above, the interrupted wall may also have thinned areas that allow the interrupted wall to deform/flex more easily as the valve 10 transitions between the closed and open modes.
Furthermore, other embodiments of the present invention may have a control member 340 with a solid wall (e.g., no interruptions or leg members 370). In such embodiments, like the embodiments having leg members 370 and interruptions, the solid wall may have one or more thinned portions that allow the solid wall to deform/flex more easily as the valve 10 transitions between the closed and open modes.
It is also important to note that, although
Accordingly, acting against the conventional wisdom of those in the art, the inventors discovered that volumes within the fluid path may be controlled more effectively by forming the resilient member 310 with a radially expanded, longitudinally smaller body portion 330. In this manner, the open mode volume of the body portion 330 is known and thus, more controllable.
This is contrary to open mode volumes of various prior art valves, which deform in a manner that can be difficult to predict. Moreover, the closed volume of the body portion 330 also is more controllable since it is known at assembly. Accordingly, the open and closed mode volumes are more readily controllable, thus enabling the relative volumes to be tuned to the needs of the application (during design).
Although the above discussion discloses various exemplary embodiments of the invention, it should be apparent that those skilled in the art can make various modifications that will achieve some of the advantages of the invention without departing from the true scope of the invention.
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