The present invention relates to an apparatus for use with medical accessories for transfer of fluid materials, and more particularly a controlled flow apparatus.
There are many instances in hospitals or in medical situations, where there is the need to transfer fluids from one source or medical accessory to a recipient, receptacle, or second medical accessory. Often, these fluids could be toxic or could pose contamination hazards. Accordingly, contamination of the environment and possible exposure of patients and medical professionals alike with biological fluids or medicines is a serious issue for medical professionals.
For example, blood is commonly drawn from a patient using a butterfly needle. However, since using a cap at the end of the tubing for a butterfly needle is not convenient, most nurses or health professionals will merely crimp the tubing to prevent blood flow from the patient to the end of the tubing. The health professional then attaches the tube to the appropriate receptacle to allow the transfer of blood from the patient to the receptacle. This method of controlling the flow and transfer of blood from a patient is cumbersome and prone to human error.
In another example, a chemotherapy agent may be administered to a patient. However, most chemotherapy agents can be toxic with concomitant dangers to the patient, medical staff, and the environment if there were an accidental release of the agent. There is a need for an apparatus that minimizes the risk of escape of the chemotherapy agent prior to infusion so as to prevent contamination of the environment or exposure of the patient or health professional to a potentially toxic compound.
In view of the foregoing, there is a need to have a controlled flow apparatus for fluid materials for use with medical accessories that reduces the risk of exposure of the environment, patient, or health professional to potentially hazardous fluids. Accordingly, it is an object of the present invention to provide a novel controlled flow apparatus for use with medical accessories. Medical accessories encompass syringes, containers, tubing associated with needles, or other apparatus that hold or transfer fluid materials in a medical setting. Fluid materials can encompass liquid and gaseous materials.
According to one embodiment of this invention, a controlled flow apparatus for medical accessories is provided, comprising a first housing having a body, a first open end, a second open end, and a hollow interior. The second open end is dimensioned for fit with a first medical accessory for flow of fluid materials from the medical accessory. A fluid flow control means is disposed within the first housing for controlling flow of fluid materials through the hollow interior from the first medical accessory. As well, there is a second housing having a body, a first open end, a hollow interior, and a second open end dimensioned for fit with the first open end of the first housing. The second open end of the second housing has an axial bore coaxial with the hollow interior of the first housing. The first open end of the second housing is dimensioned for fit with a second medical accessory for receipt of fluid materials by the second medical accessory whereby there is flow of fluid materials into said second medical accessory from the first medical accessory, via the hollow interior of the body.
In another aspect of the invention, a controlled flow apparatus for medical accessories is provided having a first housing with a body, a first open end, a second open end, and a hollow interior, where the second open end is dimensioned for fit with a first medical accessory. A one-way valve is disposed within the first housing for controlling flow of fluid materials from the first medical accessory. Suitably, the one-way valve can be a duckbill valve or an umbrella valve. There is also a second housing where one end is dimensioned for fit with the first open end of the first housing and the other end of the second housing is dimensioned for fit with a second medical accessory. Preferably this embodiment includes a valve means in the form of a valve disposed within the first housing for controlling flow of fluid materials to and from the medical accessories. In another aspect, the valve disposed within the first housing for controlling flow of fluid materials to and from the medical accessories is a combination valve with a duckbill portion and an umbrella portion. In yet another aspect, the said valve comprises least two one-way valves, where at least one one-way valve permits fluid flow in an opposite direction from at least one other one-way valve.
In another aspect of the invention, a controlled flow apparatus is provided having a first housing with a first circumferential side wall, a circumferential bottom shoulder attached thereto, and a second circumferential side wall depending from the shoulder. The second circumferential side wall has an inner diameter smaller than the inner diameter of said shoulder and defines an axial bore. This embodiment has similar structure with respect to the second housing and fluid flow control means as the prior embodiment and functions in essentially the same way as the prior embodiment.
In further aspect of the invention, a controlled flow apparatus is provided having a first housing with an end dimensioned for fit with a first medical accessory, fluid flow control means disposed within the first housing, a second housing having an end dimensioned for fit with the other end of the first housing, wherein the second housing has a circumferential side wall, a bottom plate attached thereto, an aperture in the bottom plate, and a hollow needle disposed within the aperture for fluid communication with the valve means. The circumferential side wall is dimensioned for fit with a second medical accessory such as a receptacle or syringe with a septum that is pierceable by the hollow needle to permit fluid flow, under the control of the second medical accessory, from the first medical accessory to the second medical accessory. In another aspect of the invention as described in the above embodiments, the valve means is actuable by the second medical accessory. In yet another aspect, the second housing comprises a circumferential wall extending axially outwardly from the body and a shoulder depending radially, inwardly from the end of the second housing proximal to the body and defining an aperture. Preferably the second housing has retaining means to retain a medical accessory in association with the second housing. In a further aspect, actuating means are associated with the second housing to actuate a medical accessory attached to the second housing to provide fluid communication between the medical accessory and the controlled flow apparatus.
Suitably, the ends of the first and second housings that are dimensioned for fit with medical accessories are luer fittings.
This invention also provides a controlled flow apparatus having a body with a hollow interior and two ends. A first housing extends from one end of the body, is in fluid communication with the hollow interior, and has an end distal to the body which is dimensioned for attachment with a first medical accessory. A first fluid flow control means is disposed within the first housing for controlled one-way flow of fluid materials into the interior of the body from the first medical accessory. A second housing depends from the other end of the body and is in fluid communication with the hollow interior. The end of the outlet housing distal to the body is dimensioned for fit with a second medical accessory. A second fluid flow control means is disposed within the outlet housing for controlled flow of fluid materials from the interior of the body to the second medical accessory. In yet another aspect of the invention, the first fluid control means controls fluid flow to and from the first medical accessory. The first fluid control means controlling fluid flow to and from the first medical accessory may encompass a valve controlling flow of fluid materials to and from the first medical accessory, a combination valve permitting fluid flow to and from the first medical accessory, or may comprise at least two one-way valves, wherein at least one one-way valve permits fluid flow in an opposite direction from at least one other one-way valve. In a further aspect of the invention, the second fluid flow control means controls flow of fluid to and from the second medical accessory. The second fluid control means controlling fluid flow to and from the first medical accessory may encompass a valve controlling flow of fluid materials to and from the second medical accessory, a combination valve permitting fluid flow to and from the second medical accessory, or can comprise at least two one-way valves, where at least one one-way valve permits fluid flow in an opposite direction from at least one other one-way valve.
Preferably the controlled flow apparatus is described of the invention has an additional outlet depending from the body, in fluid communication with the hollow interior. A gas flow control means can be positioned within the additional outlet to permit one-way flow of gaseous material, without expulsion of liquid material, out of the interior of the body. A hydrophobic filter is positioned in association with the aperture at the end of the additional outlet proximal to the interior of the body, to prevent liquid from entering the housing and being expelled from the outlet. Preferably, an oleophobic membrane is associated with the hydrophobic filter to prevent the hydrophobic filter from being clogged with components of the fluid material that would lessen the efficiency of the hydrophobic filter.
In another aspect of this embodiment of the invention, the second housing comprises a circumferential wall extending axially outwardly from the body and a shoulder depending radially, inwardly from the end of the second housing proximal to the body and defining an aperture. The second fluid flow control means is positioned within the second housing and is biased against the shoulder for a fluid tight fit. A valve seat is preferably attached to the shoulder and defines an aperture, and the second fluid flow control means includes a valve head which abuts against the valve seat to create a fluid tight seal. The second fluid flow means may further include a nose portion that extends axially outwardly from the bottom of the second housing proximal to the interior of the body. The valve seat is suitably made of elastomeric material to assist in creating a face seal with the second medical accessory to prevent leakage of fluid materials when the second medical accessory is mounted in the outlet housing. The valve seat preferably has an upstanding annular ring that assists in creating a face seal for fluid tight fit with the second medical accessory.
Preferably also, the outlet housing has retaining means to retain the second medical accessory in association with the outlet housing. The second valve means may be actuatable by the second medical accessory.
a are perspective views of a second preferred embodiment of a controlled flow apparatus for medical accessories according to the invention;
Disposed within central bore 22 is a combination valve 28 (
An end housing 38 is provided, dimensioned for fit with the proximal end of lower housing 12. End housing 38 has upstanding side walls 40 (
As seen in
Although housing 12 and end housing 38 have been described as being separate parts, they can also be integrally formed. Even though combination valve 28 having a duckbill and umbrella valve portions has been described as a preferred embodiment, any suitable fluid flow control means can be used such as means for two or one way flow (i.e. duckbill valve, umbrella valve), including combinations of one way flow means. It is also to be appreciated that although end housing 38 has upstanding side walls 40 interspersed with slots 42, end housing 38 can have an upstanding, continuous, circumferential side wall.
There is an outlet housing 74 extending outwardly from part 64 (
This embodiment includes a gas outlet housing 84 (
In body 62 there is a hollow interior 88 (see
As seen in
One example of an application for controlled flow apparatus 60 is for controlled flow of blood from a patient. One end of medical tubing is connected to circumferential wall 72 while the other end is attached to a butterfly needle. When the butterfly needle is inserted into a patient's vein, the blood flashes up the medical tubing under the venous pressure of the patient. The cracking pressure of one way duckbill valve 63 is less than the venous pressure of the patient, thus permitting blood to pass through the medical tubing, inlet housing 68, and duckbill valve 63 into interior 88, without the risk of blood going backwards through duckbill valve 63 to the patient.
Air within the medical tubing and interior 88 is purged from interior 88 through gas outlet housing 84. Since the cracking pressure of one way duckbill valve 86 is less than the venous pressure of the patient, when blood flashes up into interior 88, most of the air from the medical tubing and interior 88 is purged through gas outlet housing 84. Hydrophobic membrane 90 allows air to pass through duckbill valve 86 and gas outlet housing 84 into the environment without permitting blood to pass through gas outlet housing 84, thus maintaining sterility of the blood. Given that the venous pressure of the patient is sufficient to drive blood up through the medical tubing, through inlet housing 68 (by way of duckbill valve 63), into interior 88, the tubing and interior 88 are essentially purged of gases so as to reduce the likelihood that gases will be transferred through outlet housing 74, along with blood, to the medical accessory fitted with outlet housing 74.
Meanwhile, blood cannot exit controlled flow apparatus 60 once it enters into interior 88 unless valve 82 is actuated. Owing to the presence of the one way duckbill valve in inlet housing 68, blood cannot go back to the patient after having entered interior 88. In addition, blood cannot exit through gas outlet housing 84 because hydrophobic membrane 90 covers the open end of gas outlet housing 84 proximal to interior 88 and prevents blood from exiting gas outlet housing 84 to the environment, although gas can be purged from interior 88 through gas outlet housing 84.
A syringe, with a valve actuating means at the inlet end proximal to outlet housing 74 can fit onto outlet housing 74 and be retained in place with bayonet slots fitting within bayonet slots 80. When the syringe is held in place, the actuating means will push back valve body 94 rearwardly by the actuating means contacting nose 96. Valve head 98 is displaced from valve seat 92 and allows fluid communication between interior 88 and the interior of the syringe. In addition, the distal portion of the inlet end of the syringe can make a face seal with the outer surface of shoulder 90 and valve seat 92 to make a fluid tight fit between outlet housing 74 and the syringe to minimize the likelihood of blood escaping into the environment when the syringe is mounted on outlet housing 74. The syringe plunger can be pulled back to draw blood into the interior of the syringe body.
Outlet housing 108 has a circumferential wall 114 extending axially from a main body 116 of outlet housing 108, where main body 116 is proximal to inlet housing 106 and attaches to main body 112 of inlet housing 106. The end of circumferential wall 114 distal to main body 116 is open. Main body 116 also has two extending wings 118. Outlet housing 108 is dimensioned for fit with a medical accessory (not shown) to permit fluid flow between the medical accessory and outlet housing 108.
Circumferential wall 114 has bayonet slots 120 to assist in retaining a medical accessory having corresponding bayonet pins (not shown). Beads 121 (see
Main body 112 of inlet housing 106 has a hollow interior 122 (see
End 132 of circumferential wall 114 proximal to inlet housing 106 has a radially, inwardly depending shoulder 134 (see
Shoulder 134 also has an upstanding annular ring 142 (see
As can be appreciated, there can be modifications to the structures and functions described above, as additional embodiments of the invention. The inlet housing 68 and outlet housing 74 can be disposed coaxially or in offset alignment, or on the same end of body 62. In addition, the first and second housings can depend from the same end of the body, where the other end of the body is closed. As well, duckbill valves 63 and 86 can be replaced with any suitable fluid flow control means for one-way flow of fluid materials or gas from a medical accessory into the hollow interior 88 of body 60 or from the interior 88 to the environment. Umbrella valve 124 can be replaced with any suitable fluid flow control means for one-way flow of fluid materials or gas from the medical accessory into the hollow interior 122 of main body 116. In addition, body 62 can be formed integrally, as well as inlet housing 68, outlet housing 74, and gas outlet housing 84 being formed as parts that attach to body 62. Further, gas outlet housing 84 can depend on either end of body 62. Although bayonet slots 80 and 120 are described for retaining the medical accessory with outlet housings 74 and 108, any suitable retaining means can be used. In addition, one bayonet slot 80 and 120 can be used as retaining means. As can be appreciated, the fluid flow control means can be actuated by the fluid flow to and from a medical accessory, or can be actuated by the medical accessories themselves.
This application is based on and claims priority under 35 U.S.C. §119(e) with respect to U.S. provisional Application No. 60/640,088 filed on Dec. 30, 2004, the entire content of which is incorporated herein by reference.
Number | Date | Country | |
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60640088 | Dec 2004 | US |