Fluid transfer device and method of use
A fluid transfer device comprising a hollow piercing element having a first end for receiving a standard syringe nose or other similar medical device and a second end having a tapered tip for accessing fluid inside a medication container is disclosed. In a preferred embodiment, the device has a disk-shaped stop for limiting entry of the piercing element into the vial. Preferably, the piercing element includes outwardly extending barbs which allow the device to be inserted into a vial but which prevent the device from being removed from the vial after insertion. After the syringe is disengaged from the device, the device and spent medication vial may be discarded as a unit. Alternatively, the device can remain attached to the vial, and a new syringe can be used to withdraw additional fluid from the vial when desired. In an alternate embodiment, a reusable, resealable valve is connected to the first end of the piercing element, which valve allows multiple syringes to be used with the piercing element. Various adaptors for using the device with intravascular (IV) lines and drip-bags are also disclosed.
This application is a continuation of U.S. patent application Ser. No. 10/607,946, filed on Jun. 27, 2003, which is a continuation of U.S. patent application Ser. No. 09/489,189, filed on Jan. 20, 2000, now U.S. Pat. No. 6,599,273, which is a continuation of U.S. patent application Ser. No. 09/150,580, filed Sep. 10, 1998, now abandoned, which is a continuation of U.S. patent application Ser. No. 08/476,127, filed Jun. 7, 1995, now abandoned, which is a continuation of U.S. patent application Ser. No. 08/265,095, filed Jun. 24, 1994, now abandoned, which is a continuation-in-part of U.S. patent application Ser. No. 08/096,659, filed Jul. 23, 1993, which is a continuation-in-part application of PCT Application Serial No. PCT/US92/10367, filed Dec. 1, 1992, which designates the United States and is a continuation-in-part in the United States of U.S. patent application Ser. No. 07/813,073, filed Dec. 18, 1991, which is abandoned. The disclosures of these related applications are incorporated herein in their entirety by this reference thereto.
BACKGROUND OF THE INVENTION1. Field of the Invention
This invention relates to a device for transferring medication or another fluid from one location to another. This device eliminates the need for handling needles by medical personnel during the administration of medication.
2. Background Discussion
The manipulation of fluids for parenteral administration in hospital and medical settings routinely involves the use of syringes to facilitate the movement of a fluid between two points. Many syringes have needles attached which are used to pierce the seal or septum of a medicament container, or a septum in fluid communication with sterile tubing. Fluid then passes from the container or tubing into the syringe and is transferred from the syringe to an installed intravenous line (IV) or other fluid delivery system. Additionally, needles are often used to transfer fluids from one fluid line to another.
In some instances, the fluid is withdrawn from a single-dose medication container and injected into an IV system, supplementing the fluid already being administered through the IV line. These single-dose medication containers are then typically discarded. Commonly, these single-dose medication containers are “drip bags” for intravascular use, or vials, bottles, or test tubes.
Intravenous tubing sets also commonly incorporate “y-connectors” having a septum which, when penetrated, allows access to the fluid flowing within the tubing set. Syringes are often used to penetrate the septums and add or withdraw fluid from the tubing set.
The sharp needles employed with conventional syringes used to draw or introduce fluid from containers or tubing sets introduce the risk of puncture wounds to the user or patient, with a concurrent risk of exposure to a direct dose of medication which can be, in extreme instances, fatal.
A medication transfer system that is easy to use and eliminates the threat posed by exposed needles would therefore be of great benefit to the medical community.
SUMMARY OF THE INVENTIONOne embodiment of the present invention is a medication transfer device which eliminates the risk of accidental needle sticks during the handling of fluid-filled syringes having attached needles. As will be discussed in detail below, the device assists in the transfer of fluid from a sealed container to a syringe or vice versa.
The present invention comprises a piercing device used to access fluid in the interior of a vial through a pierceable seal located at the top of the vial, and facilitate the transfer of the fluid into a syringe. The device comprises a piercing element, having a hollow tube with an exterior surface, an interior bore, and at least one hole in the piercing element through which fluid flows into the interior bore of the piercing element. The device also comprises a locking structure projecting outward from the exterior surface of the piercing element. This locking structure permits penetration of the pierceable seal by the piercing element, but prohibits withdrawal of the piercing element back through the pierceable seal. A connecting portion adapted to connect the device to a syringe allows fluid from the interior of the vial to pass through the device and into the syringe. In a preferred embodiment, the device also comprises a stop which limits the extent of penetration of the piercing element into the interior of the vial. This stop may be a round disk, or a tab, located on the piercing element. Preferably, the locking structure is at least one barb, which extends at an angle away from the piercing element. The connecting portion preferably forms a substantially fluid-tight seal with the syringe.
In accordance with another aspect of the present invention, a method of accessing and transferring fluid inside a vial through a pierceable seal on the vial, using a syringe, is provided. The method comprises the steps of connecting the syringe to a device having a piercing element. This piercing element has a hollow tube having an exterior surface, an interior bore, a distal end and at least one hole proximal to the distal end. The piercing element also includes a locking structure projecting outward from the exterior surface of the piercing element. This locking structure permits penetration of the pierceable seal by the piercing element, but prohibits withdrawal of the piercing element back through the pierceable seal. The piercing element is used to pierce the seal on the vial, and is inserted into the vial until the hole proximal the distal end of the piercing element contacts the fluid inside the vial. The desired amount of fluid is withdrawn from the vial through the internal bore in the piercing element and into the syringe. The syringe is then separated from the piercing element, such that the locking structure on the piercing element prohibits the withdrawal of the piercing element through the pierceable seal. In a preferred embodiment, the syringe and the piercing element are connected before the piercing element is inserted into the vial. Alternatively, the piercing element can be inserted into the vial prior to connecting it to the syringe. The method of the present invention further comprises connecting a second syringe to the piercing element which remains in the vial, and repeating the withdrawing and separating steps to fill the second syringe. In a preferred embodiment, the syringe forms a substantially fluid-tight seal with the piercing element.
In yet another embodiment of the present invention, the piercing device is used in conjunction with a medical valve to provide a resealable fluid pathway between a vial and a syringe. In accordance with this embodiment, the valve preferably comprises a hollow housing having a spike with a seal mounted thereon located within the housing. A first end of the housing allows a syringe or other medical implement to access the seal, which may be pressed over the spike to allow fluid flow therethrough. A second end of the housing allows access to the end of said spike opposite said seal. Threads are preferably located within the second end of the housing for securing a medical connector to the free end of the spike.
In operation the piercing device described above is pressed through a seal on a vial. The connecting end of the piercing element is then connected to the free end of the spike. Threads are preferably located on the outside of the connecting end of the piercing element for locking engagement with the threads located on the housing.
A syringe may then be pressed against the seal on the other end of the valve. At that time fluid may be withdrawn from the vial through the piercing element and valve and into the syringe. This system advantageously allows disconnection of the syringe from the valve, at which time the seal reseals the spike of the medical valve, thereby sealing the passage to the vial and protecting the integrity of the fluid therein.
Another aspect of this invention is an adaptor for use with medicament containers such as a drip bag. The adaptor has a medical valve as described above, which may be removably attached by a locking mechanism to a second tubular body having a tubular spike. The spike is in fluid communication with the medicament container. Alternatively, the second body and valve may be formed integrally. In use, the valve is attached to the medicament container and then the tip of an ANSI standard connector, such as an IV set or syringe, is pressed into the valve, depressing the seal and exposing the spike within the valve. The large tubular spike on the second body is then used to penetrate the seal or septum of the medicament container, and fluid is withdrawn through the valve. The aspect of this invention related to an adaptor for use with medicament containers also relates to the following embodiments:
A medical valve adaptor for use with containers of fluid, said valve adaptor comprising:
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- a first body having proximal and distal ends, and a cavity therein;
- a first spike located within said cavity and attached to said proximal end;
- a seal located on said first spike;
- one or more tabs connected to said first body and extending from said first body into said cavity and against said first spike to lock said first spike and seal within the cavity in said first body;
- a tubular second body having proximal and distal ends;
- a tubular second spike located on the distal end of said second body and in fluid communication therewith; and
- the proximal end of said first body located integrally on the proximal end of said second body, and in fluid communication therewith.
A method of assembling a medical valve adaptor for use with containers of fluid, said valve adaptor including a first body having proximal and distal ends and a cavity therein, a first spike, a resilient seal, a second tubular body having proximal and distal ends, and a second tubular spike, said method comprising the steps of:
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- placing said seal over an end of said first spike;
- attaching said first spike, with said seal thereon, inside said cavity to the proximal end of said first body;
- creating at least one tab for securing said first spike with said seal thereon within said cavity in said first body;
- forming said second spike integrally with the distal end of said second body; and
- creating a locking mechanism integrally with the proximal end of said second body, said locking mechanism adapted to secure the proximal end of said first body to, and in fluid communication with, the proximal end of said second body.
A method of assembling a medical valve adaptor for use with a container of fluid, said valve adaptor including a first body having proximal and distal-ends and a cavity therein, a first spike, a resilient seal, a second tubular body having proximal and distal ends, and a second tubular spike, said method comprising the steps of:
-
- placing said seal over an end of said first spike;
- attaching said first spike, with said seal thereon, inside said cavity to the proximal end of said first body;
- creating at least one tab for securing said first spike with said seal thereon within said cavity in said first body;
- forming said second spike integrally with the distal end of said second body; and
- joining the proximal end of said first body to, and in fluid communication with, the proximal end of said second body.
A method of using a medical valve adaptor for use with a container of fluid and a fluid withdrawal device having a tip and an ANSI standard connector located on said tip, said valve adaptor including a first body, and a tubular second body separate from said first body, said first body having proximal and distal ends and comprising:
a cavity located therein;
-
- a first spike located within said cavity and attached to said proximal end;
- a seal located on said first spike; and
- one or more tabs connected to said first body and extending from said first body into said cavity and against said first spike to lock said first spike and seal within the cavity in said first body; said second body having proximal and distal ends and comprising:
- a tubular second spike located on the distal end of said second body and in fluid communication therewith; and
- a locking mechanism located on the proximal end of said second body, said locking mechanism adapted to secure the proximal end of said first body to, and in fluid communication with, the proximal end of said second body; said method comprising the steps of:
- attaching said first body to said second body using said locking mechanism;
- inserting the tip of said fluid withdrawal device into the distal end of said first body, depressing said seal to expose said first spike; and
- inserting said second spike into said container.
A method of using a medical valve adaptor for use with a container of fluid and a fluid withdrawal device having a tip and an ANSI standard connector located on said tip, said valve adaptor including a first body, and a tubular second body integral to and in fluid communication with said first body, said first body having proximal and distal ends and comprising:
a cavity located therein;
-
- a first spike located within said cavity and attached to said proximal end;
- a seal located on said first spike; and
- one or more tabs connected to said first body and extending from said first body into said cavity and against said first spike to lock said first spike and seal within the cavity in said first body;
- said second body having proximal and distal ends and comprising a tubular second spike located on the distal end of said second body and in fluid communication therewith, said method comprising the steps of:
- inserting the tip of said fluid withdrawal device into the distal end of said first body, depressing said seal to expose said first spike; and
- inserting said second spike into said container.
Another aspect of this invention is a three-way valved “y-connector” for use with medicament containers. The y-connector comprises the valve described above, which may be removably attached by a locking mechanism to a second tubular body having a tubular branch port which projects at an angle to the main body, and is in fluid communication with the main body. Alternatively, the second body and spike of the valve may be formed integrally. In use, the valve is attached to the second body and then the tip of an ANSI standard connector, such as an IV set or syringe, is pressed into the valve, depressing the seal and exposing the through holes of the spike within the valve. Fluid may then be introduced or withdrawn from the y-connector through the valve. The aspect of the invention related to a three-way valved “y-connector” for use with medicament containers also relates to the following embodiments:
A medical three-way valved connector for use with containers of fluid, said valved connector comprising:
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- a first body having proximal and distal ends, and a cavity therein;
- a spike located within said cavity and attached to the proximal end of said first body;
- a seal located on said spike;
- one or more tabs connected to said first body and extending from said first body into said cavity and against said spike to lock said spike and seal within the cavity in said first body;
- a tubular second body having proximal and distal ends;
- a tubular branch located at an angle to, and toward the proximal end of, said second body, and in fluid communication therewith; and
- the proximal end of said first body located integrally on the proximal end of said second body, and in fluid communication therewith.
A method of assembling a medical three-way valved connector, said valved connector including a first body having proximal and distal ends and a cavity therein, a spike, a resilient seal, a second tubular body having proximal and distal ends, and a tubular branch, said method comprising the steps of:
-
- placing said seal over an end of said spike;
- attaching said spike, with said seal thereon, inside said cavity to the proximal end of said first body;
- creating at least one tab for securing said spike with said seal thereon within said cavity in said first body;
- forming said tubular branch integrally with said second body and in fluid communication therewith; and
- creating a locking mechanism integrally with the proximal end of said second body, said locking mechanism adapted to secure the proximal end of said first body to, and in fluid communication with, the proximal end of said second body.
A method of assembling a medical three-way valved connector, said valved connector including a first body having proximal and distal ends and a cavity therein, a spike, a resilient seal, a second tubular body having proximal and distal ends, and a tubular branch, said method comprising the steps of:
-
- placing said seal over an end of said spike;
- attaching said spike, with said seal thereon, inside said cavity to the proximal end of said first body;
- creating at least one tab for securing said spike with said seal thereon within said cavity in said first body;
- forming said tubular branch integrally with said second body and in fluid communication therewith; and
- joining the proximal end of said first body to, and in fluid communication with, the proximal end of said second body.
A method of using a medical three-way valved connector and a fluid withdrawal device having a tip and an ANSI standard connector located on said tip, said valved connector having a first body and a tubular second body separate from said first body, said first body having proximal and distal ends and comprising:
-
- a cavity located therein;
- a spike located within said cavity and attached to said proximal end of said first body;
- a seal located on said spike; and
- one or more tabs connected to said first body and extending from said first body into said cavity and against said spike to lock said spike and seal within the cavity in said first body;
said second body having proximal and distal ends and comprising: - a tubular branch located at an angle to, and toward the proximal end of, said second body, and in fluid communication therewith; and
- a locking mechanism located on the proximal end of said second body, said locking mechanism adapted to secure the proximal end of said first body to, and in fluid communication with, the proximal end of said second body;
- said method comprising the steps of:
- attaching said first body to said second body using said locking mechanism; and
- inserting the tip of said fluid withdrawal device into the distal end of said first body, depressing said seal to expose said first spike.
A method of using a medical three-way valved connector and a fluid withdrawal device having a tip and an ANSI standard connector located on said tip, said valved connector having a first body and a tubular second body integral to and in fluid communication with said first body, said first body having proximal and distal ends and comprising:
-
- a cavity located therein;
- a spike located within said cavity and attached to said proximal end of said first body;
- a seal located on said spike; and
- one or more tabs connected to said first body and extending from said first body into said cavity and against said spike to lock said spike and seal within the cavity in said first body;
- said second body having proximal and distal ends and having a tubular branch located at an angle to, and toward the proximal end of, said second body, and in fluid communication therewith, said method comprising the step of inserting the tip of said fluid withdrawal device into the distal end of said first body, depressing said seal to expose said first spike.
Another aspect of the present invention is an adaptor for use with a standard piggyback or y-site connector. The adaptor comprises the medical valve described above, which may be removably attached by a locking mechanism to a second body which may have a cylindrical housing and a tubular spike located, at least partially, within the housing. The second body also has a hook, which is adapted to engage the y-site, releasably locking the adaptor to the connector. The valve is in fluid communication with the second body. In an alternative embodiment, the second body and valve may be formed integrally. In use, the valve is attached to second body. The adaptor is then placed in fluid communication and releasably locked to the y-site or piggyback connector. Thereafter, the tip of an ANSI standard connector, such as an IV set or syringe, is pressed into the valve, depressing the seal and exposing the through holes of the spike within the valve. Fluid may then be introduced or withdrawn through the adaptor to the piggyback connector. This aspect of the invention also relates to the following embodiments:
A medical valve adaptor for use with medical three-way fluid connectors, said valve adaptor comprising:
-
- a first body having proximal and distal ends, and a cavity therein;
- a first spike located within said cavity and attached to the proximal end of said first body;
- a seal located on said first spike;
- one or more tabs connected to said first body and extending from said first body into said cavity and against said first spike to lock said first spike and seal within the cavity in said first body;
- a tubular second body having proximal and distal ends;
- a cylindrical housing adapted to surround the end of said three-way connector and located on the distal end of said second body;
- a tubular second spike located on the distal end of said second body and within said housing, and in fluid communication with said second body;
- a hook located on said housing and adapted to engage said three-way connector such that said valved adaptor is secured to said three-way connector; and
- the proximal end of said first body integrally located on the proximal end of said second body, and in fluid communication therewith.
A method of assembling a medical valve adaptor, said valve adaptor including a first body having proximal and distal ends and a cavity therein, a first spike, a resilient seal, a second tubular body having proximal and distal ends, a second tubular spike, a cylindrical housing, and a hook, said method comprising the steps of:
-
- placing said seal over an end of said first spike;
- attaching said first spike, with said seal thereon, inside said cavity to the proximal end of said first body;
- creating at least one tab for securing said first spike with said seal thereon within said cavity in said first body;
- forming said housing integrally with the distal end of said second body;
- forming said second spike integrally with the distal end of said second body and located within said housing, said second spike being in fluid communication with said second body; and
- creating a locking mechanism integrally with the proximal end of said second body, said locking mechanism adapted to secure the proximal end of said first body to, and in fluid communication with, the proximal end of said second body.
A method of assembling a medical valve adaptor, said valve adaptor including a first body having proximal and distal ends and a cavity therein, a first spike, a resilient seal, a second tubular body having proximal and distal ends, a second tubular spike, a cylindrical housing, and a hook, said method comprising the steps of:
-
- placing said seal over an end of said first spike;
- attaching said first spike, with said seal thereon, inside said cavity to the proximal end of said first body;
- creating at least one tab for securing said first spike with said seal thereon within said cavity in said first body;
- forming said housing integrally with the distal end of said second body;
- forming said second spike integrally with the distal end of said second body and located within said housing, said second spike being in fluid communication with said second body; and
- joining the proximal end of said first body to, and in fluid communication with, the proximal end of said second body.
A method of using a medical valve adaptor for use with medical three-way fluid connectors and a fluid withdrawal device having a tip and an ANSI standard connector located on said tip, said valve adaptor having a first body and a tubular second body separate from said first body, said first body having proximal and distal ends and comprising:
-
- a cavity located therein;
- a spike located within said cavity and attached to said proximal end of said first body;
- a seal located on said spike; and
- one or more tabs connected to said first body and extending from said first body into said cavity and against said spike to lock said spike and seal within the cavity in said first body;
said second body having proximal and distal ends and comprising: - a tubular second body having proximal and distal ends;
- a cylindrical housing adapted to surround the end of said three-way connector and located on the distal end of said second body;
- a tubular second spike located on the distal end of said second body and within said housing, and in fluid communication with said second body;
- a hook located on said housing and adapted to engage said three-way connector such that said valved adaptor is secured to said three-way connector; and
- a locking mechanism located on the proximal end of said second body, said locking mechanism adapted to secure the proximal end of said first body to, and in fluid communication with, the proximal end of said second body; said method comprising the steps of:
- attaching said first body to said second body using said locking mechanism;
- attaching said second body to said three-way connector by surrounding the end of said three-way connector with said housing and engaging said three-way connector with said hook; and
- inserting the tip of said fluid withdrawal device into the distal end of said first body, depressing said seal to expose said first spike.
A method of using a medical valve adaptor for use with medical three-way fluid connectors and a fluid withdrawal device having a tip and an ANSI standard connector located on said tip, said valve adaptor having a first body and a tubular second body integral to and in fluid communication with said first body, said first body having proximal and distal ends and comprising:
-
- a cavity located therein;
- a spike located within said cavity and attached to said proximal end of said first body;
- a seal located on said spike; and
- one or more tabs connected to said first body and extending from said first body into said cavity and against said spike to lock said spike and seal within the cavity in said first body;
said second body having proximal and distal ends and comprising: - a tubular second body having proximal and distal ends;
- a cylindrical housing adapted to surround the end of said three-way connector and located on the distal end of said second body;
- a tubular second spike located on the distal end of said second body and within said housing, and in fluid communication with said second body; and
- a hook located on said housing and adapted to engage said three-way connector such that said valved adaptor is secured to said three-way connector;
said method comprising the steps of: - attaching said second body to said three-way connector by surrounding the end of said three-way connector with said housing and engaging said three-way connector with said hook; and
- inserting the tip of said fluid withdrawal device into the distal end of said first body, depressing said seal to expose said first spike.
This invention also comprises another adaptor for use with standard medical three-way y-connectors. The adaptor comprises the medical valve described above, which may be removably attached by a locking mechanism to a second tubular body having a cylindrical housing and a spike located within the housing. The spike is in fluid communication with the second body. The second body also has an opening in a sidewall thereof having one or more tabs. The opening is adapted to engage an arm of a standard y-connector, such that the arm “snaps” past the tabs into the opening in the side wall, releasably locking the adaptor to the connector. In an alternative embodiment, the second body and valve may be formed integrally with one another. In use, the valve is attached to the second body and then the tip of an ANSI standard connector, such as an IV set or syringe, is pressed into the valve, depressing the seal and exposing the spike within the valve. The tubular spike on the second body is then used to penetrate the seal or septum of the y-connector. When the second body is pressed onto the y-connector, the opening and tabs surround an arm of the piggyback connector. The arm “snaps” past the tabs, which holds the adaptor in place, releasably locking the adaptor to the connector. Fluid is then introduced or withdrawn through the adaptor. This other adaptor also relates to the following embodiments:
A medical valve adaptor for use with medical three-way fluid connectors, said valve adaptor comprising:
-
- a first body having proximal and distal ends, and a cavity therein;
- a first spike located within said cavity and attached to the proximal end of said first body;
- a seal located on said first spike;
- one or more tabs connected to said first body and extending from said first body into said cavity and against said first spike to lock said first spike and seal within the cavity in said first body;
- a tubular second body having proximal and distal ends;
- a cylindrical housing adapted to surround the end of said three-way connector and located on the distal end of said second body;
- a tubular second spike located on the-distal end of said second body and within said housing, and in fluid communication with said second body;
- an opening having one or more tabs, said opening located on said housing and adapted to engage said three-way connector such that said valved adaptor is secured to said three-way connector and partially held in place by said tabs; and
- the proximal end of said first body integrally located on the proximal end of said second body, and in fluid communication therewith.
A method of assembling a medical valve adaptor, said valve adaptor including a first body having proximal and distal ends and a cavity therein, a first spike, a resilient seal, a second tubular body having proximal and distal ends, a second tubular spike, and a cylindrical housing having an opening with one or more tabs, said method comprising the steps of:
-
- placing said seal over an end of said first spike;
- attaching said first spike, with said seal thereon, inside said cavity to the proximal end of said first body;
- creating at least one tab for securing said first spike with said seal thereon within said cavity in said first body;
- forming said housing integrally with the distal end of said second body;
- forming said second spike integrally with the distal end of said second body and located within said housing, said second spike being in fluid communication with said second body; and
- creating a locking mechanism integrally with the proximal end of said second body, said locking mechanism adapted to secure the proximal end of said first body to, and in fluid communication with, the proximal end of said second body.
A method of assembling a medical valve adaptor, said valve adaptor including a first body having proximal and distal ends and a cavity therein, a first spike, a resilient seal, a second tubular body having proximal and distal ends, a second tubular spike, and a cylindrical housing having an opening with one or more tabs, said method comprising the steps of:
-
- placing said seal over an end of said first spike;
- attaching said first spike, with said seal thereon, inside said cavity to the proximal end of said first body;
- creating at least one tab for securing said first spike with said seal thereon within said cavity in said first body;
- forming said housing integrally with the distal end of said second body;
- forming said second spike integrally with the distal end of said second body and located within said housing, said second spike being in fluid communication with said second body; and
- joining the proximal end of said first body to, and in fluid communication with, the proximal end of said second body.
A method of using a medical valve adaptor for use with medical three-way fluid connectors and a fluid withdrawal device having a tip and an ANSI standard connector located on said tip, said valve adaptor having a first body and a tubular second body separate from said first body, said first body having proximal and distal ends and comprising:
-
- a cavity located therein;
- a spike located within said cavity and attached to said proximal end of said first body;
- a seal located on said spike; and
- one or more tabs connected to said first body and extending from said first body into said cavity and against said spike to lock said spike and seal within the cavity in said first body;
said second body having proximal and distal ends and comprising: - a tubular second body having proximal and distal ends;
- a cylindrical housing adapted to surround the end of said three-way connector and located on the distal end of said second body;
- a tubular second spike located on the distal end of said second body and within said housing, and in fluid communication with said second body;
- an opening having one or more tabs, said opening located on said housing and adapted to engage said three-way connector such that said valved adaptor is secured to said three-way connector and partially held in place by said tabs; and
- a locking mechanism located on the proximal end of said second body, said locking mechanism adapted to secure the proximal end of said first body to, and in fluid communication with, the proximal end of said second body; said method comprising the steps of:
- attaching said first body to said second body using said locking mechanism;
- attaching said second body to said three-way connector by surrounding the end of said three-way connector with said housing and engaging said three-way connector with said opening and tabs; and
- inserting the tip of said fluid withdrawal device into the distal end of said first body, depressing said seal to expose said first spike.
A method of using a medical valve adaptor for use with medical three-way fluid connectors and a fluid withdrawal device having a tip and an ANSI standard connector located on said tip, said valve adaptor having a first body and a tubular second body integral to and in fluid communication with said first body, said first body having proximal and distal ends and comprising:
-
- a cavity located therein;
- a spike located within said cavity and attached to said proximal end of said first body;
- a seal located on said spike; and
- one or more tabs connected to said first body and extending from said first body into said cavity and against said spike to lock said spike and seal within the cavity in said first body;
said second body having proximal and distal ends and comprising: - a tubular second body having proximal and distal ends;
- a cylindrical housing adapted to surround the end of said three-way connector and located on the distal end of said second body;
- a tubular second spike located on the distal end of said second body and within said housing, and-in fluid communication with said second body; and
- an opening having one or more tabs, said opening located on said housing and adapted to engage said three-way connector such that said valved adaptor is secured to said three-way connector and partially held in place by said tabs;
said method comprising the steps of: - attaching said second body to said three-way connector by surrounding the end of said three-way connector with said housing and engaging said three-way connector with said opening and tabs; and
- inserting the tip of said fluid withdrawal device into the distal end of said first body, depressing said seal to expose said first spike.
Still another aspect of this invention is an adaptor for use with narrowly necked medicament containers such as test tubes. The adaptor comprises the medical valve described above, which may be removably attached by a locking mechanism to a second tubular body having an open-ended tube. The open-ended tube is in fluid communication with the second body. Alternatively, the second body and valve may be formed integrally with one another. In use, the valve is attached to the second body and then the tip of an ANSI standard connector, such as an IV set or syringe, is pressed into the valve, depressing the seal and exposing the spike within the valve. The open-ended tube on the second body is then inserted into the narrowly necked container, and fluid is withdrawn through the adaptor. This aspect of the invention also relates to the following embodiments:
A medical valve adaptor for use with medical three-way fluid connectors, said valve adaptor comprising:
-
- a first body having proximal and distal ends, and a cavity therein;
- a first spike located within said cavity and attached to the proximal end of said first body;
- a seal located on said first spike;
- one or more tabs connected to said first body and extending from said first body into said cavity and against said first spike to lock said first spike and seal within the cavity in said first body;
- a tubular second body having proximal and distal ends;
- an open-ended tube adapted to reach into and withdraw fluids from said narrowly necked container, said tube-located on the distal end of and in fluid communication with said second body; and
- the proximal end of said first body integrally located on the proximal end of said second body, and in fluid communication therewith.
A method of assembling a medical valve adaptor, said valve adaptor including a first body having proximal and distal ends and a cavity therein, a first spike, a resilient seal, a second tubular body having proximal and distal ends, and an open-ended tube, said method comprising the steps of:
-
- placing said seal over an end of said first spike;
- attaching said first spike, with said seal thereon, inside said cavity to the proximal end of said first body;
- creating at least one tab for securing said first spike with said seal thereon within said cavity in said first body;
- attaching said open-ended tube to, and in fluid communication with, the distal end of said second body; and
- creating a locking mechanism integrally with the proximal end of said second body, said locking mechanism adapted to secure the proximal end of said first body to, and in fluid communication with, the proximal end of said second body.
A method of assembling a medical valve adaptor, said valve adaptor including a first body having proximal and distal ends and a cavity therein, a first spike, a resilient seal, a second tubular body having proximal and distal ends, and an open-ended tube, said method comprising the steps of:
-
- placing said seal over an end of said first spike;
- attaching said first spike, with said seal thereon, inside said cavity to the proximal end of said first body;
- creating at least one tab for securing said first spike with said seal thereon within said cavity in said first body;
- attaching said open-ended tube to, and in fluid communication with, the distal end of said second body; and
- joining the proximal end of said first body to, and in fluid communication with, the proximal end of said second body.
A method of using a medical valve adaptor for use with a narrowly necked container of fluid and a fluid withdrawal device having a tip and an ANSI standard connector located on said tip, said valve adaptor including a first body, and a tubular second body separate from said first body, said first body having proximal and distal ends and comprising:
a cavity located therein;
-
- a first spike located within said cavity and attached to said proximal end;
- a seal located on said first spike; and
- one or more tabs connected to said first body and extending from said first body into said cavity and against said first spike to lock said first spike and seal within the cavity in said first body; said second body having proximal and distal ends and comprising:
- a tubular second body having proximal and distal ends;
- an open-ended tube adapted to reach into and withdraw fluids from said narrowly necked container, said tube located on the distal end of and in fluid communication with said second body; and
- a locking mechanism located on the proximal end of said second body, said locking mechanism adapted to secure the proximal end of said first body to, and in fluid communication with, the proximal end of said second body;
said method comprising the steps of: - attaching said first body to said second body using said locking mechanism;
- inserting the tip of said fluid withdrawal device into the distal end of said first body, depressing said seal to expose said first spike; and
- inserting said open-ended tube into said narrowly necked container.
A method of using a medical valve adaptor for use with a narrowly necked container of fluid and a fluid withdrawal device having a tip and an ANSI standard connector located on said tip, said valve adaptor including a first body, and a tubular second body integral to and in fluid communication with said first body, said first body having proximal and distal ends and comprising:
a cavity located therein;
-
- a first spike located within said cavity and attached to said proximal end;
- a seal located on said first spike; and
- one or more tabs connected to said first body and extending from said first body into said cavity and against said first spike to lock said first spike and seal within the cavity in said first body;
said second body having proximal and distal ends and comprising: - a tubular second body having proximal and distal ends; and
- an open-ended tube adapted to reach into and withdraw fluids from said narrowly necked container, said tube located on the distal end of and in fluid communication with said second body;
said method comprising the steps of: - inserting the tip of said fluid withdrawal device into the distal end of said first body, depressing said seal to expose said first spike; and
- inserting said open-ended tube into said narrowly necked container.
Alternatively, each of the adaptors discussed above may be used by first placing the adaptor in fluid communication with the piggyback connector or other container and thereafter depressing the seal in the valve with an ANSI standard connector such as an IV set or syringe in order to introduce or withdraw fluid through the adaptor.
BRIEF DESCRIPTION OF THE DRAWINGS
As shown in
Fluid medication may be delivered to patients by drawing the medication from the vial 524 through the piercing element 520 into the syringe 522, and thereafter injecting the fluid from the syringe 522 into an existing IV delivery system. This method will be discussed in more detail below.
Preferably, the piercing element 520 has a proximal end 570 and a distal end 580. The proximal end 570 of the piercing element 520 preferably has a connecting portion which may be in the form of a tubular extension 526, adapted to receive the tip or nose 528 of an ANSI (American National Standards Institute, Washington, D.C.) standard syringe 522. It is, however, contemplated that the inner diameter of the tubular extension 526 can be of any size to accommodate the attachment of any of a number of medical implements. Once inserted into a bore 552 of the extension 526, the nose 528 of the syringe 522 forms a substantially fluid-tight fit with the extension 526. Preferably, bore 552 becomes slightly smaller in diameter from distal end 570 of extension 526 towards the proximal end 580 to accommodate a tapered nose 528 and form a tight seal. The taper of the bore 552 is preferably at the same angle as the nose 528 of the syringe 522 and, more preferably, in accordance with ANSI standards, the taper is 0.006 inch per linear inch. Although a fluid-tight seal is achieved, the tapered shape of these cooperating parts also allows them to be easily disengaged with a minimal separation force.
The medication vial 524 generally comprises a container portion 538 having a narrow neck 539 on which a cap or lid 536 fits. A resilient septum 534 is placed over a circular opening 535 in the lid 536 to simultaneously provide a seal for the vial 524 and an access site for the piercing element 520. The septum is prepared from a resilient material that is flexible, inert, impermeable to fluid and readily pierceable by the piercing element 520.
Referring now to
As described above, preferably at least one longitudinal through hole 548 is provided proximal the distal end 580 of the piercing element 520 to permit fluid to flow from the container 524 into the bore 552. Advantageously, by placing the through hole 548 proximal the distal end 580 of the piercing element 520, the risk of coring the septum 534 with the piercing element 520 is eliminated. If the through hole 548 were to be located at the distal end 580 of the piercing element 520, the piercing element 520 may core the septum 534 introducing particulates into the fluid which may harm a patient. In a preferred embodiment, there are three through-holes 548 within about 0.200 inch from the distal end 580 of the piercing element 520. These through-holes 548 may be of any size; however, the larger the size of the through-holes, the greater the fluid flow rate through the bore 552 of the piercing element 520. In a preferred embodiment, the size of the through-holes 548 are 18-gauge or equivalent to provide a flow rate three times that of a standard 18-gauge needle.
In a preferred embodiment, a disk-shaped stop 530 centrally located on the piercing element 520 is integral with, and interconnects, the extension 526 and the penetrating portion 532 of the piercing element 520. A distal face 540 on the disk-shaped stop 530 may contact a top surface 537 of the cap 536 of the vial 524 to limit the distance the piercing element 520 may extend into the vial 524. The stop 530 may, of course, have a variety of shapes and configurations.
A locking structure 550 is preferably attached to or integral with the piercing element 520. In one embodiment, the locking structure 550 may comprise two barbs on diametrically opposed sides of the piercing element 520 near the distal end 580. The barbs are desirably angled in the proximal direction in order to more easily pass through the elastomeric septum 534 into the vial 524. The barbs prevent the removal of the penetration portion 544 of the piercing element 520 back through the septum 534. The locking structure 550 thus retains a portion of the piercing element 520 in the vial 524. In one embodiment, the piercing element 520 is approximately 0.125 inch in diameter and the locking structure 550 extends at a 45° angle towards the proximal end a distance of approximately 0.0625 inch.
It is possible for the locking structure 550 to be located other than at the distal end 580 of the piercing element. For example, the locking element may comprise a somewhat elongate barbed structure, which extends from the piercing element 520 some distance from the distal end 580. Alternatively, the locking structure 550 may extend from the stop 530 of the piercing element, depending on its location. For example, one or more barb-like structures may extend downwardly from the stop 530 along a side of the piercing element 520.
Method of Using the Vial Access Device
The vial access device of the present invention provides a closed system for transferring a predetermined amount of medication from a remote source to a patient. Referring to
After the desired amount of fluid has been drawn into the syringe 522, the syringe 522 is pulled away from the vial 524. Upon retraction of the syringe 522 from the piercing element 520, the locking structure 550 catches on the inner side of the septum 534, preventing the piercing element 520 from disengaging the vial 524. Further refraction force causes the syringe nose 528 to disengage from the piercing element 520. The user then transfers the fluid within the syringe 522 to a delivery system which administers the medication to the patient.
Preferably, if fluid remains in the vial 524 after the desired volume of fluid is transferred to the syringe 522, the syringe 522 is withdrawn from the piercing element 520 as shown in
The piercing element 520 is partially trapped in the vial 524 by the locking structure 550. The single-dose medication vial 524 and piercing element 520 may then be discarded as a unit. Advantageously, by not removing the penetration portion 544 of the piercing element 520 from the vial, the risk of a healthcare worker injuring himself or herself on the penetration portion 544 or locking structure 550 of the piercing element is eliminated. Alternatively, if the vial contains sufficient medication for more than a single dose, a new syringe can be attached to the piercing element 520 held within the medication vial 524 and additional fluid can be transferred from the vial 524, through the piercing element 520 and into the new syringe 522.
The piercing element 520 is preferably manufactured from a hard plastic. The piercing element 520 may also be manufactured from other medically inert materials known to those of skill in the art. One particular advantage of this invention is that it eliminates the use of metal needles. This dramatically reduces the risk of skin puncture during the administration of fluids contained in a vial to a patient. The piercing element 520 need only be strong enough to penetrate the septum 534 of a vial 524 or other similar seal.
Alternate Embodiment In a second embodiment as shown in
As best shown in
Referring to
In the first embodiment, the upper conduit 20 is adapted to receive the tip or nose 48 of an ANSI standard syringe 46 (see
Referring to
The hollow spike 26 has a tapered conical shape, ending in a sharp, pointed tip 32. Preferably, along the length of the spike are raised, protruding ridges 30. These raised ridges 30 extend from the surface of the spike preferably between 0.2 and 2.0 mm. The ridges 30 are preferably aligned along the length of the spike as illustrated in
The seal 36 has a seal cap 40 with a generally flat top surface 40b, an outwardly tapered sidewall 38, and a lower lip 42. Its interior is hollow to provide the conically shaped cavity 37 (
The base of the seal 36 has a width such that the seal lip 42 fits snugly into the annular cuff 28. The hollow interior or cavity 37 (
Proper selection of the dimensions of the annular cuff 28 and the annular ring 14 will provide a fluid tight closure for the valve 10. However, if the outside diameter of the annular cuff 28 is too small relative to the inside diameter of the annular ring 14, then, referring to
The seal 36 fits into the annular cuff 28 and is held in place by an internal lip 27 along the internal portion of the annular ring 14 of the housing 12. The length of the spike 24 is such that, after assembly, the tip of the spike rests below the plane defined by the lip 25 of the housing 12. Preferably, the spike tip 32 is approximately from 0.525″ to 0.1″ below the lip 25 of the housing 12. The seal 36 fits snugly against the spike 24 and is essentially flush with the lip 25 of the housing 12. The spike tip 32 is thus embedded within the seal cap 40 prior to use or may be approximately 0.025″ distal the seal cap 40 when the valve 10 is in the closed position. The inner conduit 18 is partially shielded by the bell shaped skirt 16 of the housing 12 (see
During use, the invention is designed to be adapted as a two-way valve. The orientation of the valve is independent to fluid flow and dependent on the preferred orientation of the preexisting connections. Thus, the invention can be used as a valve connector for an intravenous central or peripheral piggyback connector in either orientation. Parenteral fluid is delivered to patients through tubing such that the liquid flows from a container through a needle into the patient. The containers are frequently changed or additional fluid bottles are added. The invention disclosed herein is designed to interconnect medical implements along the route of fluid delivery to the patient. However, the invention is also useful in any environment in which a resealable fluid valve is desired. During use, a connector of the appropriate size is fitted over the inner conduit 18. Locking can be achieved by a Luer-Lock mechanism, a pressure fit or any other locking mechanisms known to those with skill in the art, as described above. Thus, in one example, fluid passes from the inner conduit 18 into the spike 26. However, fluid flow is locked in place by the seal 36.
Upon removal of the syringe from spike 26, as shown in
Advantageously, the through-holes 34 are located relatively low on the spike 26. Thus, the through-holes 34 are sealed relatively early in the process as the seal 36 returns to its original configuration when the valve 10 is closed. In one preferred embodiment the through holes 34 are located 0.075″ below the spike tip 32 (see
A cover cap (not shown) can be supplied to fit over the upper conduit 20 as further protection for the seal surface between use. Such a cover cap, however, is not needed to maintain sterility since the seal 36 may be swabbed with a disinfectant after each use. The reversibility of the seal 36 makes the valve 10 particularly attractive as a connector valve to provide fluid communication between two fluid lines. Therefore, the present invention provides for placing a first fluid line in communication with a second fluid line using the valve disclosed herein. The reversibility of the valve 10 permits multiple fluid lines to be successively added, for example, to a fluid line in direct communication with a patient's vein. Since the valve is easily sterilizable and sealable, fluid lines can be added and removed without disconnecting venous contact.
The valve 10 is preferably prepared from a hard plastic, but it is additionally contemplated that the valve could be prepared from other medically inert materials known to those in the art. The spike element 24 is preferably prepared from the same material as the housing 12. One particular advantage of this invention is that it does not rely on the use of metal needles. This dramatically reduces the risk of skin puncture during use and manufacture. Further, the upper conduit 20 serves as a shield to the spike 26 such that skin puncture is further reduced. The spike 26 need only be strong enough to penetrate the seal cap 40, or if necessary, to pierce a connecting septum.
In the embodiment of the invention illustrated in
An important advantage of the invention is that the valve 10 has very little dead space, thus the volume of liquid entering into the valve is substantially equivalent to the volume of fluid leaving the valve. Further, the total equivalent fluid volume of the valve is very small such that the volume of fluid flowing through the system in order to place the valve in fluid communication with a medical implement such as a syringe 22 is substantially zero.
An alternative embodiment of the seal, a seal 36a, is shown in
Referring to
An alternative embodiment of the seal, a seal 36b is shown in connection with the valve 10 in
As shown in
Another alternative embodiment of the seal, a seal 36d, is shown in
As mentioned above, preferably seal 36d has a precut slit 211 in the cap 92 lying along the longitudinal axis of the valve 10. The seal cap 92 has a unique configuration that insures that the slit 211 closes and is sealed upon withdrawal of a syringe (not shown) and reformation of the seal 36d. It includes an enlarged, internal, pressure responsive member 200 which is integral with the cap 92. Between the proximal end of the side wall 150 and the member 200 is an annular space 102 which is filled with the fluid in the cavity 98. This fluid is under pressure, for example at the blood pressure of the patient to which the valve 10 is attached. Referring to
Preferably, there is a tear ring 104 integral with the member 200 along the perimeter of the internal surface of the member 200, and a slight saucer-like depression 204 in the external surface of the seal. The pressure responsive element in the decompressed state closes any orifice in the seal 36d to provide an essentially fluid-tight seal while in the decompressed state. The pressure responsive member 200 enables the valve to maintain a fluid-tight seal even at very high pressures sometimes experienced in medical applications, particularly when the valve 10 is connected to a patient's artery. The center of the member 200 and the annular space 102 are coaxial with the entryway 211a to the orifice 211. The pressurized fluid fills the annular space 102 to apply pressure that compresses the member 200 to tightly close the entryway to the orifice. In a preferred embodiment the distance from the entryway 211a to the proximal end of seal cap 92 is from 0.500 to 0.075 inches and more preferably approximately 0.100 inch.
As best illustrated in
Another alternative embodiment of the present invention using the seal 36d is shown in
As best shown in
Other components of the present invention interact with the various embodiments of the seal in a similar fashion to their interaction with seal 36 of
In general, the closing of the valve 10 is provided not by the side wall of the seal 36 which immediately covers the through-holes 34, but by the beat cap 40, or seal cap 92 filling the proximal end of the cavity 98 and the opening 25a. Thus, the seal caps 40 and 92 are sufficiently thick to reseal the opening 25a effectively after valve closure. However, the seal caps 40 and 92 should also be sufficiently thin to allow them to readily return to the closed position. Preferably the thickness of the caps 40 and 92 ranges between 0.075 and 0.500 inch and more preferably may be approximately 0.100 inch.
The valve disclosed in this invention can be provided in a sterile and disposable form such that after its use in a given installation is exhausted, the device is discarded. However, as described above, in any given installation, the device can be reused multiple times. Since the device does not employ needles, there is little chance that the device will inadvertently cause skin puncture. Therefore, the extra precautions required for handling and disposing of needles is obviated. It will be apparent from the detailed description provided herein that the present invention can provide for the elimination of nearly all needles used in the medical environment. With the use of the valve of the present invention, the need for all needles except those that are directly input into a patient is, advantageously, eliminated.
Still referring to
The securing force provided by the retaining tabs 252c reduces the need for friction or interference fit between the external portion of annular cuff 28 and the inner surface 254 of annular ring 14, as described above with respect to the first method of assembly. Thus, the outside diameter of the annular cuff 28 can be reduced relative to the inside diameter of the annular ring 14, without allowing leakage to occur within the medical valve 11. For example, it has been found that the outside diameter of the annular cuff 28 can be as little as about 0.003″ larger than the inside diameter of the ring 14 and still provide a proper seal. The ability to reduce the diameter of cuff 28 (in relation to the diameter of the ring 14) reduces the possibility that the housing 12 will crack in response to hoop stress, even when the spike element 24 expands because of the conduction of lipids, or other fats. Further, the lessened importance of providing exact tolerances between the annular cuff 28 and the annular ring 14 allows for variations in the materials and the manufacturing process of these components, reducing manufacturing costs.
Preferably, the contact surface 276 of the gouging bit 262 contacts the upper surface of the annular cuff 28 of the spike element 24. It is noted that the gouging bit 262 is sized such that the gouging edge 266 extends beyond the outside perimeter of the spike element 24, including the annular detent 28b.
The valve housing 12 is placed inside of the hole 268 located in the base 260, with the distal end of the housing 111 protruding from the base 260. Once the gouging bit 262 and the base 260 are positioned so that their centers are in direct vertical alignment, the base 260 is moved upwardly, toward the gouging bit 262 (although, as one skilled in the art will recognize, alternately, the bit 262 may be moved downwardly towards the base 260). As the base 260 approaches the gouging bit 262, the base 260 forces the housing 12 around the outside of the spike element 24 and the seal 36, so that the spike element 24 and the seal 36 penetrate the housing 12. Continued movement of the base 260 causes the housing 12 to be pushed up around the spike element 24 and the seal 36 until the distal portion of the annular ring 14 of the housing 12 makes contact with the annular cuff 28 of the spike element 24, as shown in
Referring again to
However, the housing 12 and bit 262 are sized such that the gouging edge 266 of the gouging bit 262 does make contact with the housing 12 at the gouging surface 252a. In this manner, the gouging edge 266 of the gouging bit 262 gouges a portion of the gouging surface 252a away from the inner surface of the housing 12. The portion of the gouging surface 252a that is partially separated from the housing 12 is folded or crushed in towards the center of the gouging bit 262 and down toward the annular cuff 28 of the spike element 24 between pairs of ribs 297 by the guiding surfaces 292, 294, 296 to form a number of retaining tabs 252c, as shown in
The method described above is the preferred method of assembly for the improved medical valve 11 of the present invention. However, this improved method of assembly can be modified in numerous ways without departing from the essential teachings of the present invention.
Referring again to
Substantial force is required to drive the base 260 toward the gouging bit 262 with sufficient force to insert the spike element 24 into the housing 12 and to gouge the gouging surface 252a of the housing 12 and create the retaining tabs 252c. Preferably, therefore, this assembly is accomplished through use of a machine 286.
Movement of the piston 284 pushes the base 260 in which the valve housing 12 is located upwardly until the annular cuff 28 of the spike element 24 contacts the annular ring 14 of the housing 12. During this procedure, the gouging edge 266 of the gouging bit 262 gouges a portion of the gouging surface 252a away from the inner surface of the housing 12 to create the retaining tabs 252c. A mechanical stop (not shown) is preferably used to prevent the base 260 from being driven too far relative to the gouging bit 262.
After the components of the medical valve have been assembled, the handle 280 is released and returned to its normal position as shown in
Although
The valve 10 or 11 is used to provide a closed, patient access system for transferring a predetermined amount of medication from a remote source to the patient. The valve 10 or 11 is connected by the distal end to the patient, for example, a vein or artery in fluid communication with the valve. Blood fills the valve, but the seal 36d, for example, prevents any blood from leaking from the valve. The delivery end or nose 28 of the medical implement (such as syringe 22) is inserted into the valve as depicted in
In particular, in the preferred embodiment, the proximal end 570 of the piercing element 520 has a number of threads 588 located on the outside surface thereof for engagement with the threads 45 inside of the housing 12 of valve 10 or 11. These threads 588 may comprise standard threads, or, as shown, short wings for engaging the threads 45 of the housing 12. When the proximal end 570 of the piercing element 520 is threadingly engaged with the distal end of the valve 10 or 11, the valve 10 or 11 and piercing element 520 form a fluid tight seal.
It is also contemplated that the piercing element 520 and valve 10 or 11 may be made as a single element, wherein the conduit 18 of the valve 10 or 11 and the connection portion at the proximal end 570 of the piercing element 520 comprise a continuous single conduit or element. In one version the piercing element 520 (without threads thereon) may be connected to the conduit 18 of the valve 10 or 11 and be permanently affixed thereto. This may be done, for example, by fusing the conduit 18 into the connecting portion of the piercing element or by any other means known to one skilled in the art. Alternatively, the spike 24 may be formed as an extension of the proximal end 570 of the piercing element 520.
Method of Using the Alternate Embodiment In operation, the piercing element 520 is preferably threaded into engagement with the housing 12 of the valve 10 or 11. The penetrating portion 532 of the piercing element 520 is then inserted through the septum 534 of the vial 524. Lastly, as best illustrated in
Advantageously, the syringe 22 may be disengaged from the valve 10 or 11 at any time. Once disengaged, the fluid conduit is automatically closed by the seal 36 in the valve 10 or 11. This system allows later withdrawal of fluid with another syringe 22, without the fear of contamination of the fluid in the vial between uses.
Drip Bag Adaptor
In another preferred embodiment of the invention, illustrated by
The adaptor 311 is preferably made of any medically inert material. In a preferred embodiment of the adaptor 311, and especially where disposability is desired, the adaptor 311 is constructed of rigid plastic. In other embodiments, however, and particularly where reusability is desired, the adaptor 311 may be made of stainless steel or any other medically inert substance, to allow sterilization in an autoclave or similar device.
A longitudinal channel 313 leads from the proximal end of the spike to the distal end of the adaptor 311, providing a route for fluid to flow through the adaptor 311. The channel 313 is typically cylindrical although it may also be slightly frustoconical to accommodate the change in diameter from the tip of the spike 311 to the distal end of the adaptor 311. In the preferred embodiment of the adaptor 311, the channel 313 has a generally smooth interior surface, to facilitate the easy flow of fluid through the adaptor 311.
Near the distal end of the spike is preferably located a flange 317, of a size and shape to sealably conform to the surface of the seal 316. In this manner, the spike 312 and flange 317 serve to first penetrate the seal 316 and next mate with the seal 316, preventing leakage of fluid from the container 315 around the outside surface of the adaptor 311. In addition, the flange 31 7 prevents the adaptor 311 from entirely transversing the seal 316.
In one embodiment, shown in
The body 314 may be of any length necessary to accommodate easy connection to the fluid container 315. In particular, it is advantageous that the body 314 be long enough to provide the user an adequate gripping surface, to facilitate installation and removal of the adaptor 311. In a preferred embodiment of the adaptor 311, the body 314 is approximately 1.625 inches long.
In one preferred embodiment of the adaptor 311, shown in
Alternatively, as shown in
The adaptor 311 is thus useable with containers having a seal. Examples of containers with such seals contemplated for use with this invention include medicament drip bags, bottles for intravenous delivery of fluids, or the like.
In use, the adaptor 311 coupled with a valve 10 or 11 is typically inserted into a medicament drip bag or the like. Thereafter, the tip or nose of an ANSI standard IV set, syringe, or other connector or medical implement, is then pushed into the proximal end of the medical valve 10 or 11. Referring now to
Y-Connector with Integral Valve
Another embodiment of the present invention is shown in
The connector 331 is preferably made of any medically inert material. Advantageously, the connector 331 may be made of a transparent material, allowing a user to see whether fluid is flowing therethrough. In one preferred embodiment of the connector 331, and especially where disposability is desired, the connector is constructed of rigid transparent plastic.
A longitudinal channel 334 runs through the body 332 from the proximal end to the distal end, providing continuous fluid communication from the through holes 34 of the spike element 24 through the connector 331. The channel 334 is generally cylindrical in shape, although it may be slightly conical or have internal step changes in diameter to accommodate the difference in diameter between the base of the spike element 24 and the distal end of the body 332. Furthermore, in the preferred embodiment of the connector 331 the channel 334 has a generally smooth interior surface, to facilitate the flow of fluid through the connector 331.
Toward the proximal end of the body 332 is provided the tubular branch port 335, which has a longitudinal channel 336 located therethrough. The channel 336 is in fluid communication with the channel 334 of the main body 332, and is, like the main channel 334, generally cylindrical in shape. In addition, the channel 336 preferably has a generally smooth interior surface.
The spike element 24 is preferably formed integrally with the main body 332. To form a plastic body with a continuous through-channel (such as the body 332 of this connector 331), an effective method of manufacture is to use a bore pin to manufacture the connector 331. The connector 331 of the present invention has the advantage of easy manufacture at low cost. In addition, the connector 331 will be less bulky, and will have a lower weight, than a connector in which the spike element 24 is formed separately and then mechanically attached.
At a later time, before use, the seal 36 and housing 12 of the medical valve 10 or 11 of other preferred embodiments can be placed over the spike element 24 and attached by such means as were described earlier in the discussion of those embodiments.
In use, the distal end of the body 332 can be placed in fluid communication with flexible tubing (not shown) or another fluid transmitting device or medical implement. The end of the branch port 335 can be, like the distal end of the body 332, placed in fluid communication with a source of fluid or other fluid transmitting device or medical implement.
The connector 331 typically connects one or two fluid sources with a fluid receiver such as a patient. A first fluid source or parenteral fluid is, in use, placed in fluid communication with the tubular branch port 335. The fluid receiver, such as a patient, is, in use, placed in fluid communication with the distal end of the body 332. In this manner, the first fluid flows from its source through the branch port channel 336 into the main channel 334 and then to the fluid-receiver or patient.
When a second fluid needs to be administered to a patient, the tip or nose of an ANSI standard syringe or other medical implement is pushed into the end of the medical valve 10 or 11. Referring now to
Hook Adaptor for Y-Connectors
The hook adaptor 351 is preferably made of any medically inert material. In a preferred embodiment of the hook adaptor 351, and especially where disposability is desired, the hook adaptor 351 is constructed of rigid plastic. In other embodiments, however, and particularly where reusability is desired, the hook adaptor 351 may be made of stainless steel or any like substance, to allow sterilization in an autoclave or similar device.
As shown in
Referring to
The housing 355 may furthermore have a section 352 removed from a portion of the distal end of the housing wall 358, to accommodate the arm of the piggyback connector when the adaptor 351 is in the connected and locked position (see discussion below).
Centrally located within the housing 355 is a spike 356. The spike 356 is tubular, having a narrow channel 353 running longitudinally therethrough, providing a route for fluid to flow through the spike 356 and into the body 354 of the adaptor 351. The spike 356 will preferably penetrate a septum located on the end of the branch port. The spike 356 may be of any length and shape, to accommodate a range of septum sizes. Most advantageously, the spike is approximately as long as, or smaller than, the depth of the housing 355, so that the end of the spike does not substantially protrude beyond the distal end 358 of the housing 355. This prevents a user from accidentally sticking himself or herself with the spike 356. In a preferred embodiment of the adaptor 351, shown in
The spike 356 should furthermore be smooth surfaced, and as thin as possible to avoid substantially rupturing or coring of the septum of the branch port of the piggyback connector during insertion and/or removal, yet large enough to provide a sufficient channel 353 for fluids, especially liquids, to pass easily therethrough. In particular, it is contemplated that the adaptor 351 may be repeatedly connected to, and removed from, the same connector.
The longitudinal channel 353 is typically cylindrical although it may also be slightly frustoconical to accommodate the change in diameter from the tip of the spike 356 to the base 359 of the housing 355. In the preferred embodiment of the adaptor 351, the channel 353 has a generally smooth interior surface, to facilitate the easy flow of fluid through the adaptor 351.
The body 354 may be of any length necessary to accommodate easy connection to the piggyback connector. In particular, it is advantageous that the body 354 be long enough to provide the user an adequate gripping surface, to facilitate installation and removal of the adaptor 351. In a preferred embodiment of the adaptor 351, the body 354 is approximately 0.41 inches long, measured from the base 359 of the housing 355 to the proximal end of the body 354.
In one preferred embodiment of the adaptor 351, shown in
Alternatively, as shown in
The hook 357 is of a size and shape to rotatably engage an arm of the y-site. The hook 357 preferably leads downward from the housing 355 at a slight angle, to accommodate the angle at which the branch port departs from the main body or arm of the y-site. In the preferred embodiment of the adaptor 351 shown in
In use, the housing 355 of the adaptor 351 is placed over the end of the branch port of the y-site, and then pressed down until the spike 356 penetrates the septum on the branch port, providing fluid communication between the adaptor 351 and the y-site. The adaptor 351 is then rotated until the hook 357 engages the arm of the y-site, firmly holding the adaptor 351 onto the y-site, and preventing accidental disconnection of the adaptor 351. To remove the adaptor 351, a user merely rotates the hook 357 in the opposite direction, disengaging the hook 357 from the y-site.
If using an adaptor 351 of the type shown in
The tip or nose of an ANSI standard IV set, syringe, or other connector or medical implement, is then pushed into the proximal end of the medical valve 10 or 11. Referring now to
Snap-On Adaptor for Piggyback Connector
Another embodiment of the present invention is shown in
The snap-on adaptor 371 is preferably made of any sterile, medically inert material. In addition, the material should be capable of slight elastic deformation, to allow the adaptor 371 to “snap” into position (see description of use, below). In the preferred embodiment of the snap-on adaptor 371, and especially where disposability is desired, the adaptor 371 is constructed of rigid plastic. In other embodiments, however, and particularly where reusability is desired, the adaptor 371 may be made of stainless steel or any like substance, to allow sterilization in an autoclave or similar device.
As shown in
The adaptor housing 375 is generally cylindrical and of a size and shape to closely surround the end of the branch port or other arm of the standard y-site. The housing 37.5 wall has an opening 372, shaped to closely accommodate the branch port or arm of the piggyback connector when the adaptor 371 is connected to the y-site.
The opening 372 is preferably just wide enough to allow the branch port or arm of the y-site to pass easily therethrough. In addition, in the preferred embodiment of the adaptor 371 as shown in
Toward the distal end 378 of the housing 375, the opening 372 narrows sharply and then gradually widens, so that a pair of opposing and spaced apart tabs 377a, 377b are formed, integral with the housing 375. The tabs 377a, 377b are spaced apart a distance sufficient to prevent the passage of the branch port or arm of the y-site therethrough, unless deliberate pressure is applied. In the preferred embodiment of the adaptor 371, the tabs 377a, 377b are spaced apart by approximately 0.09 inches.
The opening 372 gradually widens from the tabs 377a, 377b toward the distal end of the housing wall 378, thus providing entrance bearing surfaces 373a, 373b which assist in guiding an arm of the y-site into the opening 372. In the preferred embodiment of the adaptor 371 shown in
Centrally located within the housing 375 is the spike 376. The spike 376 is tubular, having a narrow channel 381 running longitudinally therethrough, providing a route for fluid to flow through the spike 376 and into the body 374 of the adaptor 371. The spike 376 will preferably penetrate a septum located on a branch port of a y-site. The spike 376 may be of any length and shape, to accommodate a range of seal sizes. Most advantageously, the spike does not protrude past the distal end of the housing 375. This prevents a user from accidentally sticking himself or herself with the spike 376. In a preferred embodiment of the adaptor 371, shown in
The spike 376 should furthermore be smooth surfaced, and as thin as possible to avoid substantially rupturing the septum on the branch port of the piggyback connector during insertion and/or removal, yet large enough to provide a sufficient channel 381 for fluids, especially liquids, to pass easily therethrough. In particular, it is contemplated that the adaptor 371 may be repeatedly connected to, and removed from, the same y-site, potentially tearing small pieces of the septum off in the process. This poses the danger of causing particles of the septum to enter the fluid stream of the y-site, contaminating the stream and possibly harming a patient. Therefore, in the preferred embodiment of the adaptor 371, the spike 376 is only about 0.05 inches in diameter.
The longitudinal channel 381 is typically cylindrical although it may also be slightly frustoconical to accommodate the change in diameter from the tip of the spike 376 to the base 379 of the housing 375. In a preferred embodiment of the adaptor 371, the channel 381 has a generally smooth interior surface, to facilitate the easy flow of fluid through the adaptor 371.
The body 374 may be of any length necessary to accommodate easy connection to the y-site. In particular, it is advantageous that the body 374 be long enough to provide the user an adequate gripping surface, to facilitate installation and removal of the adaptor 371. In the preferred embodiment of the adaptor 371, the body 374 is approximately 0.3 inches long, measured from the base 379 of the housing 375 to the proximal end of the body 374.
In one preferred embodiment of the adaptor 371, shown in
Alternatively, as shown in
In use, the housing 375 of the adaptor 371 is placed over the end of the branch port of the y-site, and then advanced so that the spike 376 pierces the septum on the branch port. A deliberate force must be applied so that the arm of the y-site passes through the tabs 377a, 377b and into the opening 372. Constant pressure on the adaptor 371 thus causes the arm of the y-site to snap into the opening, and contemporaneously the spike 376 penetrates the septum, providing fluid communication between the y-site and adaptor 371.
To remove the adaptor 371, the user must deliberately pull the adaptor 371 off the y-site.
If using an adaptor 371 of the type shown in
The tip or nose of an ANSI standard IV set, syringe, or other connector, is then pushed into the proximal end of the medical valve 10 or 11. Referring now to
Test Tube Adaptor
The test tube adaptor 391 is preferably made of any medically inert material. In the preferred embodiment of the test tube adaptor 391, and especially where disposability is desired, the test tube adaptor 391 is constructed of plastic. In other embodiments, however, and particularly where reusability is desired, the test tube adaptor 391 may be made of stainless steel or any like substance, to allow sterilization in an autoclave or similar device.
As shown in
The tube 395 is preferably flexible, and transparent, so that a user can see whether fluid is flowing therein. In the preferred embodiment the tube 395 is constructed of flexible medical tubing. In addition, the tube 395 should be of a length sufficient to reach substantially into a test tube or similar narrowly necked container, so that fluids can be withdrawn. In the preferred embodiment, the tube 395 is approximately 5.5 inches long. The tube 395 should also have an inner diameter sufficient to allow fluids, especially liquids, to pass easily therethrough. In the preferred embodiment, the tube 395 has an inner diameter of approximately 0.03 inches.
The body 394 is generally cylindrical, although it may also be conical or have a neck to accommodate the change in diameter from its proximal end to the distal end where the tube 395 is attached.
In one preferred embodiment of the adaptor 391, shown in
Alternatively, as shown in
In use, the tube 395 of the adaptor 391 is placed into the test tube or other container. If using an adaptor 391 of the type shown in
The foregoing provides a description of the best mode contemplated of carrying out the present invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains to make and use the invention. Although certain embodiments have been described, it is intended that the scope of the invention not be limited to the specific embodiments described. It will be appreciated that certain modification and variations may suggest themselves to those skilled in the art. The spirit and scope of the invention are limited solely by the following claims.
Claims
1. A medical connector for controlling the flow of fluid from a plurality of fluid sources, the connector comprising:
- a first tubular body including a proximal end, a distal end, and a wall structure including a fluid passage;
- a valve including a housing comprising a first portion, a second portion, and an internal cavity, the first portion having a proximal end including an opening, the first portion configured to receive a delivery end of a first medical implement, the second portion of the housing having a distal end in fluid communication with the proximal end of the first tubular body, a first region of the internal cavity positioned near the proximal end of the first portion of the housing and having at least a first cross-sectional width, a second region of the internal cavity in a distal direction from the first region having at least a second cross-sectional width being larger than the first cross-sectional width; a seal element comprising a proximal end, a distal end, an internal cavity, an external surface, and a radially outwardly extending portion, the seal element adapted to move from a first position in which the proximal end of the seal element is positioned adjacent the opening of the housing and a second position in which the proximal end of the seal element is positioned in a distal direction from its location in the first position, the proximal end of the seal element fills essentially completely the opening of the housing and further comprises an orifice extending between an external surface of the proximal end of the seal element and the internal cavity of the seal element, the orifice configured to facilitate fluid flow through the valve when the seal element is in the second position, wherein an outward portion of the radially outwardly extending portion is positioned between the first portion of the housing and the second portion of the housing; and a rigid element positioned within the internal cavity of the seal element, the rigid element configured to assist in maintaining the position of the seal element when the seal element moves from the first position to the second position;
- a second tubular body having a wall structure including a fluid passage such that the fluid passage is in direct communication with the fluid passage of the first tubular body, and wherein the first tubular body defines a first axial centerline and the second tubular body defines a second axial centerline extending at an angle to the first axial centerline.
Type: Application
Filed: May 3, 2006
Publication Date: Sep 7, 2006
Inventor: George Lopez (Corona del Mar, CA)
Application Number: 11/418,417
International Classification: A61M 5/00 (20060101);
