US20040002684A1 - Fluid transfer device and method of use - Google Patents

Abstract

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.

Description

RELATED APPLICATIONS
• This application 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.[0001]
BACKGROUND OF THE INVENTION
• 1. Field of the Invention[0002]
• 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.[0003]
• 2. Background Discussion[0004]
• 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.[0005]
• 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.[0006]
• 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.[0007]
• 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.[0008]
• 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.[0009]
SUMMARY OF THE INVENTION
• One 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.[0010]
• 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 th 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.[0011]
• 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.[0012]
• 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 th 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.[0013]
• 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.[0014]
• 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.[0015]
• 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:[0016]
• A medical valve adaptor for use with containers of fluid, said valve adaptor comprising:[0017]
• a first body having proximal and distal ends, and a cavity therein;[0018]
• a first spike located within said cavity and attached to said proximal end;[0019]
• a seal located on said first spike;[0020]
• 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;[0021]
• a tubular second body having proximal and distal ends;[0022]
• a tubular second spike located on the distal end of said second body and in fluid communication therewith; and[0023]
• the proximal end of said first body located integrally on the proximal end of said second body, and in fluid communication therewith.[0024]
• 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:[0025]
• placing said seal over an end of said first spike;[0026]
• attaching said first spike, with said seal thereon, inside said cavity to the proximal end of said first body;[0027]
• creating at least one tab for securing said first spike with said seal thereon within said cavity in said first body;[0028]
• forming said second spike integrally with the distal end of said second body; and[0029]
• creating a locking mechanism integrally with the proximal end of said second body, said locking mechanism adapted to s cure the proximal end of said first body to, and in fluid communication with, the proximal end of said second body.[0030]
• 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:[0031]
• placing said seal over an end of said first spike;[0032]
• attaching said first spike, with said seal thereon, inside said cavity to the proximal end of said first body;[0033]
• creating at least one tab for securing said first spike with said seal thereon within said cavity in said first body;[0034]
• forming said second spike integrally with the distal end of said second body; and[0035]
• joining the proximal end of said first body to, and in fluid communication with, the proximal end of said second body.[0036]
• 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:[0037]
• a cavity located therein;[0038]
• a first spike located within said cavity and attached to said proximal end;[0039]
• a seal located on said first spike, and[0040]
• 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;[0041]
• said second body having proximal and distal ends and comprising:[0042]
• a tubular second spike located on the distal end of said second body and in fluid communication therewith; and[0043]
• 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;[0044]
• said method comprising the steps of:[0045]
• attaching said first body to said second body using said locking mechanism;[0046]
• 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[0047]
• inserting said second spike into said container.[0048]
• 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:[0049]
• a cavity located therein;[0050]
• a first spike located within said cavity and attached to said proximal end;[0051]
• a seal located on said first spike; and[0052]
• 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;[0053]
• 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:[0054]
• inserting the tip of said fluid withdrawal devic into th distal end of said first body, depressing said seal to expose said first spike; and[0055]
• inserting said second spike into said container.[0056]
• Another aspect of this invention is a three-way valved “y-connector” for use with medicament containers. The y-connector comprises the valv 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 valv 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:[0057]
• A medical three-way valved connector for use with containers of fluid, said valved connector comprising:[0058]
• a first body having proximal and distal ends, and a cavity therein;[0059]
• a spike located within said cavity and attached to the proximal end of said first body;[0060]
• a seal located on said spike;[0061]
• one or more tab's 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;[0062]
• a tubular second body having proximal and distal ends;[0063]
• a tubular branch located at an angle to, and toward the proximal end of, said second body, and in fluid communication therewith; and[0064]
• the proximal end of said first body located integrally on the proximal end of said second body, and in fluid communication therewith.[0065]
• 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:[0066]
• placing said seal over an end of said spike;[0067]
• attaching said spike, with said seal thereon, inside said cavity to the proximal end of said-first body;[0068]
• creating at least one tab for securing said spike with said seal thereon within said cavity in said first body;[0069]
• forming said tubular branch integrally with said second body and in fluid communication therewith; and[0070]
• 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.[0071]
• 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:[0072]
• placing said seal over an end of said spike;[0073]
• attaching said spike, with said seal thereon, inside said cavity to the proximal end of said first body;[0074]
• creating at least one tab for securing said spike with said seal thereon within said cavity in said first body;[0075]
• forming said tubular branch integrally with said second body and in fluid communication therewith; and[0076]
• joining the proximal end of said first body to, and in fluid communication with, the proximal end of said second body.[0077]
• 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:[0078]
• a cavity located therein;[0079]
• a spike located within said cavity and attached to said proximal end of said first body;[0080]
• a seal located on said spike; and[0081]
• 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;[0082]
• said second body having proximal and distal ends and comprising:[0083]
• a tubular branch located at an angle to, and toward the proximal end of, said second body, and in fluid communication therewith; and[0084]
• 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;[0085]
• said method comprising the steps of:[0086]
• attaching said first body to said second body using said locking mechanism; and[0087]
• inserting the tip of said fluid withdrawal device into the distal end of said first body, depressing said seal to expose said first spike.[0088]
• 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:[0089]
• a cavity located therein;[0090]
• a spike located within said cavity and attached to said proximal end of said first body;[0091]
• a seal located on said spike; and[0092]
• 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;[0093]
• 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.[0094]
• 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:[0095]
• A medical valve adaptor for use with medical three-way fluid connectors, said valve adaptor comprising:[0096]
• a first body having proximal and distal ends, and a cavity therein;[0097]
• a first spike located within said cavity and attached to the proximal end of said first body;[0098]
• a seal located on said first spike;[0099]
• 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;[0100]
• a tubular second body having proximal and distal ends;[0101]
• a cylindrical housing adapted to surround the end of said three-way connector and located on the distal end of said second body;[0102]
• 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;[0103]
• 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[0104]
• the proximal end of said first body integrally located on the proximal end of said second body, and in fluid communication therewith.[0105]
• 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:[0106]
• placing said seal over an end of said first spike;[0107]
• attaching said first spike, with said seal thereon, inside said cavity to the proximal end of said first body;[0108]
• creating at least one tab for securing said first spike with said seal thereon within said cavity in said first body;[0109]
• forming said housing integrally with the distal end of said second body;[0110]
• 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[0111]
• 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.[0112]
• 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:[0113]
• placing said seal over an end of said first spike;[0114]
• attaching said first spike, with said seal thereon, inside said cavity to the proximal end of said first body;[0115]
• creating at least one tab for securing said first spike with said seal thereon within said cavity in said first body;[0116]
• forming said housing integrally with the distal end of said second body;[0117]
• 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[0118]
• joining the proximal end of said first body to, and in fluid communication with, the proximal end of said second body.[0119]
• 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:[0120]
• a cavity located therein;[0121]
• a spike located within said cavity and attached to said proximal end of said first body;[0122]
• a seal located on said spike, and[0123]
• 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;[0124]
• said second body having proximal and distal ends and comprising:[0125]
• a tubular second body having proximal and distal ends;[0126]
• a cylindrical housing adapted to surround the end of said three-way connector and located on the distal end of said second body;[0127]
• 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;[0128]
• 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[0129]
• 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;[0130]
• said method comprising the steps of:[0131]
• attaching said first body to said second body using said locking mechanism;[0132]
• 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[0133]
• inserting the tip of said fluid withdrawal device into the distal end of said first body, depressing said seal to expose said first spike.[0134]
• 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:[0135]
• a cavity located therein;[0136]
• a spike located within said cavity and attached to said proximal end of said first body;[0137]
• a seal located on said spike; and[0138]
• 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;[0139]
• said second body having proximal and distal ends and comprising:[0140]
• a tubular second body having proximal and distal ends;[0141]
• a cylindrical housing adapted to surround the end of said three-way connector and located on the distal end of said second body;[0142]
• 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[0143]
• 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;[0144]
• said method comprising the steps of:[0145]
• 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[0146]
• inserting the tip of said fluid withdrawal device into the distal end of said first body, depressing said seal to expose said first spike.[0147]
• 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 side wall 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:[0148]
• A medical valve adaptor for use with medical three-way fluid connectors, said valve adaptor comprising:[0149]
• a first body having proximal and distal ends, and a cavity therein;[0150]
• a first spike located within said cavity and attached to the proximal end of said first body;[0151]
• a seal located on said first spike;[0152]
• 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;[0153]
• a tubular second body having proximal and distal ends;[0154]
• a cylindrical housing adapted to surround the end of said three-way connector and located on the distal end of said second body;[0155]
• 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;[0156]
• 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[0157]
• the proximal end of said first body integrally located on the proximal end of said second body, and in fluid communication therewith.[0158]
• 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:[0159]
• placing said seal over an end of said first spike;[0160]
• attaching said first spike, with said seal thereon, inside said cavity to the proximal end of said first body;[0161]
• creating at least one tab for securing said first spike with said seal thereon within said cavity in said first body;[0162]
• forming said housing integrally with the distal end of said second body;[0163]
• 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[0164]
• 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.[0165]
• A method of assembling a medical valve adaptor, said valv 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:[0166]
• placing said seal over an end of said first spike;[0167]
• attaching said first spike, with said seal thereon, inside said cavity to the proximal end of said first body;[0168]
• creating at least one tab for securing said first spike with said seal thereon within said cavity in said first body;[0169]
• forming said housing integrally with the distal end of said second body;[0170]
• 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[0171]
• joining the proximal end of said first body to, and in fluid communication with, the proximal end of said second body.[0172]
• 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:[0173]
• a cavity located therein;[0174]
• a spike located within said cavity and attached to said proximal end of said first body;[0175]
• a seal located on said spike; and[0176]
• 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;[0177]
• said second body having proximal and distal ends and comprising:[0178]
• a tubular second body having proximal and distal ends;[0179]
• a cylindrical housing adapted to surround the end of said three-way connector and located on the distal end of said second body;[0180]
• 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;[0181]
• 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[0182]
• 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;[0183]
• said method comprising the steps of:[0184]
• attaching said first body to said second body using said locking mechanism;[0185]
• attaching said second body to said three-way connector surrounding the end of said three-way connector with said housing and engaging said three-way connector with said opening and tabs; and[0186]
• inserting the tip of said fluid withdrawal device into the distal end of said first body, depressing said seal to expose said first spike.[0187]
• 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:[0188]
• a cavity located therein;[0189]
• a spike located within said cavity and attached to said proximal end of said first body;[0190]
• a seal located on said spike; and[0191]
• 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;[0192]
• said second body having proximal and distal ends and comprising:[0193]
• a tubular second body having proximal and distal ends;[0194]
• a cylindrical housing adapted to surround the end of said three-way connector and located on the distal end of said second body;[0195]
• 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[0196]
• 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;[0197]
• said method comprising the steps of:[0198]
• 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[0199]
• inserting the tip of said fluid withdrawal device into the distal end of said first body, depressing said seal to expose said first spike.[0200]
• 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:[0201]
• A medical valve adaptor for use with medical three-way fluid connectors, said valve adaptor comprising:[0202]
• a first body having proximal and distal ends, and a cavity therein;[0203]
• a first spike located within said cavity and attached to the proximal end of said first body;[0204]
• a seal located on said first spike;[0205]
• 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;[0206]
• a tubular second body having proximal and distal ends;[0207]
• 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[0208]
• the proximal end of said first body integrally located on the proximal end of said second body, and in fluid communication therewith.[0209]
• 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:[0210]
• placing said seal over an end of said first spike;[0211]
• attaching said first spike, with said seal thereon, inside said cavity to the proximal end of said first body;[0212]
• creating at least one tab for securing said first spike with said seal thereon within said cavity in said first body;[0213]
• attaching said open-ended tube to, and in fluid communication with, the distal end of said second body; and[0214]
• 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.[0215]
• 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:[0216]
• placing said seal over an end of said first spike;[0217]
• attaching said first spike, with said seal thereon, inside said cavity to the proximal end of said first body;[0218]
• creating at least one tab for securing said first spike with said seal thereon within said cavity in said first body;[0219]
• attaching said open-ended tube to, and in fluid communication with, the distal end of said second body; and[0220]
• joining the proximal end of said first body to, and in fluid communication with, the proximal end of said second body.[0221]
• 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:[0222]
• a cavity located therein;[0223]
• a first spike located within said cavity and attached to said proximal end;[0224]
• a seal located on said first spike; and[0225]
• 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;[0226]
• said second body having proximal and distal ends and comprising:[0227]
• a tubular second body having proximal and distal ends;[0228]
• 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[0229]
• 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;[0230]
• said method comprising the steps of:[0231]
• attaching said first body to said second body using said locking mechanism;[0232]
• 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[0233]
• inserting said open-ended tube into said narrowly neck d container.[0234]
• 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:[0235]
• a cavity located therein;[0236]
• a first spike located within said cavity and attached to said proximal end;[0237]
• a seal located on said first spike; and[0238]
• 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;[0239]
• said second body having proximal and distal ends and comprising:[0240]
• a tubular second body having proximal and distal ends; and[0241]
• 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;[0242]
• said method comprising the steps of:[0243]
• 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[0244]
• inserting said open-ended tube into said narrowly necked container.[0245]
• 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.[0246]
BRIEF DESCRIPTION OF THE DRAWING
• FIG. 1 is an exploded perspective view of a medication transfer device of the present invention in a typical orientation for drawing medication from a sealed vial.[0247]
• FIG. 2 is an exploded perspective view of the system of FIG. 1, inverted.[0248]
• FIG. 3 is a perspective view of the first embodiment of the valve of this invention.[0249]
• FIG. 4 is an exploded perspective view of the valve shown in FIG. 1 illustrating the spike, seal, and the body or housing components of the invention.[0250]
• FIG. 5 is a longitudinal cross-sectional view of th valve of FIG. 1, after assembly by a first assembly method.[0251]
• FIG. 6 is a schematic, longitudinal, cross-sectional view of the assembled valve of FIG. 1 before compressing the seal.[0252]
• FIG. 7 is a schematic, longitudinal, cross-sectional view similar to FIG. 6 showing the valve during compression of the seal.[0253]
• FIG. 8 is a schematic illustration of an ANSI delivery end of a medical implement compressing the seal of the valve of this invention.[0254]
• FIG. 9 is a side elevation view, partially in cross-section,-of a third embodiment of the seal.[0255]
• FIG. 10 is a longitudinal cross-sectional view of the assembled valve of FIG. 1 using the seal of FIG. 9.[0256]
• FIG. 11 is a longitudinal cross-sectional view of the assembled valve of FIG. 1, using a fourth embodiment of the seal.[0257]
• FIG. 12 is a longitudinal cross-sectional view of the assembled valv of FIG. 1, using a fifth embodiment of the seal.[0258]
• FIG. 13 is a longitudinal cross-sectional view of a sixth embodiment of the seal.[0259]
• FIG. 14 is a longitudinal section of the seal shown in FIG. 13 used in connection with the spike device shown in FIG. 2.[0260]
• FIG. 15 is a longitudinal partial cross-sectional view of a seventh embodiment of the seal of this invention.[0261]
• FIG. 16 is a longitudinal cross-sectional view, after assembly, of the embodiment of the valve shown utilizing the seal of FIG. 15.[0262]
• FIG. 17 is a longitudinal cross-sectional view, after assembly, of the eighth embodiment of the valve of this invention.[0263]
• FIG. 18 is a longitudinal cross-sectional view, after assembly, of the ninth embodiment of the valve of this invention.[0264]
• FIG. 19 is a side elevation view, after assembly, of the seal and spike shown in FIG. 14 connected to the body or housing shown in FIGS. 20 and 21.[0265]
• FIG. 20 is a cross-sectional view taken along line[0266]20-20 of FIG. 19.
• FIG. 21 is a perspective view, with sections broken away to show the wall structure of the cavity containing the seal shown in FIGS. 13 and 14.[0267]
• FIG. 22 is a greatly enlarged, cross-sectional view taken along line[0268]22-22 of FIG. 14.
• FIG. 23 is a longitudinal cross-sectional view of the body of a tenth embodiment of the valve of this invention, which is suitable for use in a second assembly method.[0269]
• FIG. 24 is a longitudinal cross-sectional view of the body of an eleventh embodiment of the valve of this invention, which is also suitable for use in the second assembly method.[0270]
• FIG. 25 is a longitudinal cross-sectional view of the tenth embodiment of the valve of the present invention, comprising-the spike and seal components from FIG. 3 and the body component from FIG. 23, assembled by using the second assembly method, or a functionally equivalent method.[0271]
• FIG. 26 is a perspective view of a gouging bit and a base which ar preferably used in the second assembly method.[0272]
• FIG. 27 is a cross-sectional view of the bit of FIG. 26 taken along line[0273]27-27 thereof.
• FIG. 28 is a longitudinal cross-sectional view of the components of the assembled valve of FIG. 25, before assembly, inserted with the gouging bit and base of FIG. 26.[0274]
• FIG. 29 is a longitudinal cross-sectional view of the assembled valve of FIG. 25,-along with the gouging bit and base of FIG. 26.[0275]
• FIG. 30 is an enlarged view of the area inside line[0276]30-30 of FIG. 29.
• FIG. 31 illustrates a partial cross-sectional view of a manually operated punch machine for using the gouging bit and base of FIG. 26 to perform the second assembly method on the valve components shown as illustrated in FIG. 28.[0277]
• FIG. 32 is an exploded perspective view of a preferred medication transfer device utilized with a medical valve and syringe.[0278]
• FIG. 33 is a partially exploded side view of one embodiment of a drip bag adaptor made in accordance with the present invention, showing the relationship between the drip bag, adaptor, and removable valve.[0279]
• FIG. 34 is a side view of another embodiment of the drip bag adaptor, having an integral valve.[0280]
• FIG. 35 is a-side view of a new Y-site or piggyback y-connector made in accordance with the present invention.[0281]
• FIG. 36 is a partially exploded side view of a hook adaptor made in accordance with this invention.[0282]
• FIG. 37 is a plan view of the hook adaptor shown in FIG. 36, as viewed from the bottom.[0283]
• FIG. 38 is a side view of another embodiment of the hook adaptor, having an integral valve.[0284]
• FIG. 39 is a partially exploded side view of a snap-on adaptor made in accordance with this invention.[0285]
• FIG. 40 is a plan view of the snap-on adaptor shown in FIG. 39, as viewed from the bottom.[0286]
• FIG. 41 is a side view of another embodiment of the snap-on adaptor, having an integral valve.[0287]
• FIG. 42 is a partially exploded side view of a test tube adaptor made in accordance with the present invention.[0288]
• FIG. 43 is a side view of another embodiment of the test tube adaptor, having an integral valve.[0289]
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• As shown in FIGS. 1 and 2, a first embodiment of the present invention generally comprises a piercing[0290]element520 for use in a medication container access system. The system includes a standard medical implement used to measure and deliver a dose of fluid medication, such as asyringe522, and a bottle orvial524 containing the medication. Preferably, a single-dose vial suitable for disposal after one use is used, whereby the piercingelement520 may be disposable. FIGS. 1 and 2 are exploded views of the system, with FIG. 1 showing the typical orientation of the system when fluid is withdrawn from thevial524. FIG. 2 shows an inverted orientation in order to better illustrate some of the elements of the present invention.
• Fluid medication may be delivered to patients by drawing the medication from the[0291]vial524 through the piercingelement520 into thesyringe522, and thereafter injecting the fluid from thesyringe522 into an existing IV delivery system. This method will be discussed in more detail below.
• Preferably, the piercing[0292]element520 has aproximal end570 and adistal end580. Theproximal end570 of the piercingelement520 preferably has a connecting portion which may be in the form of atubular extension526, adapted to receive the tip ornose528 of an ANSI (American National Standards Institute, Washington, D.C.)standard syringe522. It is, however, contemplated that the inner diameter of thetubular extension526 can be of any size to accommodate the attachment of any of a number of medical implements. Once inserted into abore552 of theextension526, thenose528 of thesyringe522 forms a substantially fluid-tight fit with theextension526. Preferably, bore552 becomes slightly smaller in diameter fromdistal end570 ofextension526 towards theproximal end580 to accommodate atapered nose528 and form a tight seal. The taper of thebore552 is preferably at the same angle as thenose528 of thesyringe522 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[0293]medication vial524 generally comprises acontainer portion538 having anarrow neck539 on which a cap orlid536 fits. Aresilient septum534 is placed over acircular opening535 in thelid536 to simultaneously provide a seal for thevial524 and an access site for the piercingelement520. The septum is prepared from a resilient material that is flexible, inert, impermeable to fluid and readily pierceable by the piercingelement520.
• Referring now to FIG. 2, the piercing elem nt[0294]520 preferably has, at itsdistal end580, apenetration portion532.Th penetration portion532 preferably is sized so as to be able to pierce theseptum534 of thevial524 and extend into contact with the medication within thecontainer538. A fluid flow conduit in the form of bore 0.552 runs from at least onehole548 in the piercingelement520, through to theproximal end570 of the side wall of the piercingelement520. In a preferred embodiment, thepenetration portion532 of the piercingelement520 has a taperedconical tip544. Preferably, th distal end of thetip544 is shaped to allow thetip544 to pierce theseptum534 of thevial524 and, therefore, thepenetration portion532 is sharply pointed. However, thepenetration portion532 may be slightly round to prevent accidental sticks and yet still be able to penetrate theseptum534.
• As described above, preferably at least one longitudinal through[0295]hole548 is provided proximal the distal end0.580 of the piercingelement520 to permit fluid to flow from thecontainer524 into thebore552. Advantageously, by placing the throughhole548 proximal thedistal end580 of the piercingelement520, the risk of coring theseptum534 with the piercingelement520 is eliminated. If the throughhole548 were to be located at thedistal end580 of the piercingelement520, the piercingelement520 may core theseptum534 introducing particulates into the fluid which may harm a patient. In a preferred embodiment, there are three through-holes548 within about 0.200 inch from the distal end 0.580 of the piercingelement520. These through-holes548 may be of any size; however, the larger the size of the through-holes, the greater the fluid flow rate through thebore552 of the piercingelement520. In a preferred embodiment, the size of the through-holes548 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[0296]stop530 centrally located on the piercingelement520 is integral with, and interconnects, theextension526 and the penetratingportion532 of the piercingelement520. Adistal face540 on the disk-shapedstop530 may contact atop surface537 of thecap536 of thevial524 to limit the distanc the piercingelement520 may extend into thevial524. Thestop530 may, of course, have a variety of shapes and configurations.
• A locking[0297]structure550 is preferably attached to or integral with the piercingelement520. In one embodiment, the lockingstructure550 may comprise two barbs on diametrically opposed sides of the piercingelement520 near thedistal end580. The barbs are desirably angled in the proximal direction in order to more easily pass through theelastomeric septum534 into thevial524. The barbs prevent the removal of thepenetration portion544 of the piercingelement520 back through theseptum534. The lockingstructure550 thus retains a portion of the piercingelement520 in thevial524. In one embodiment, the piercingelement520 is approximately 0.125 inch in diameter and the lockingstructure550 extends at a 45° angle towards the proximal end a distance of approximately 0.0625 inch.
• It is possible for the locking[0298]structure550 to be located other than at thedistal end580 of the piercing element. For example, the locking element may comprise a somewhat elongate barbed structure, which extends from the piercingelement520 some distance from thedistal end580. Alternatively, the lockingstructure550 may extend from the stop 0.530 of the piercing element, depending on its location. For example, one or more barb-like structures may extend downwardly from thestop530 along a side of the piercingelement520.
• Method of Using the Vial Access Device[0299]
• 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 FIGS. 1 and 2, the delivery end or[0300]nose528 of a medical implement such as a syringe is engaged with the piercingelement520. Thenose528 is pushed into the proximal end ofbore552 of the piercingelement520 until a substantially fluid-tight fit is achieved between thesyringe522 and the piercingelement520. Thedistal end580 of the piercingelement520 is then inserted through theseptum534 of themedication vial524. Thevial524 is generally held in an inverted position, as shown in FIG. 1, such that the fluid in the vial abuts theseptum534. The penetratingportion544 of the piercingelement520 and the lockingstructure550 are pushed through theseptum534, thereby exposing the through-hole(s)548 to the fluid inside thevial524. Aplunger560 inside thesyringe522 is withdrawn, thereby creating a vacuum which draws fluid from thevial524, through the through hole(s)548, thebore552, aconduit556 in thesyringe nose528 and into achamber558 in thesyringe522. The desired amount of medication is thus transferred from thevial524, through the piercingelement520 and into thesyringe522.
• After the desired amount of fluid has been drawn into the[0301]syringe522, thesyringe522 is pulled away from thevial524. Upon retraction of thesyringe522 from the piercingelement520, the lockingstructure550 catches on the inner side of theseptum534, preventing-thepiercing element520 from disengaging thevial524. Further refraction force causes thesyringe nose528 to disengage from the piercingelement520. The user then transfers the fluid within thesyringe522 to a delivery system which administers the medication to the patient.
• Preferably, if fluid remains in the[0302]vial524 after the desired volume of fluid is transferred to thesyringe522, thesyringe522 is withdrawn from the piercingelement520 as shown in FIG. 2 so that the fluid contained in thevial524 does not spill. The vacuum created in thesyringe522 prevents the fluid medication from exiting thesyringe522 through theconduit556 in thesyringe nose528.
• The piercing[0303]element520 is partially trapped in thevial524 by the lockingstructure550. The single-dose medication vial524 and piercingelement520 may then be discarded as a unit. Advantageously, by not removing thepenetration portion544 of the piercingelement520 from the vial, the risk of a healthcare worker injuring himself or herself on thepenetration portion544 or lockingstructure550 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 piercingelement520 held within themedication vial524 and additional fluid can be transferred fromth vial524, through the piercingelement520 and into thenew syringe522.
• The piercing[0304]element520 is preferably manufactured from a hard plastic. The piercingelement520 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 piercingelement520 need only be strong enough to penetrate theseptum534 of avial524 or other similar seal.
• Alternate Embodiment[0305]
• In a second embodiment as shown in FIG. 32 and described in more detail below, the piercing[0306]element520 is used in conjunction with amedical valve10 or11 described below in order to transfer fluid from avial524 to asyringe522.
• FIGS.[0307]3-31 illustrate themedical valve10 or11 and methods of manufacturing thevalve10 or11. In this description and in conjunction with the FIGURES, the term “proximal” is used to denote the end of the valve and other components at or near thespike tip32 in FIGS. 4 through 8,10 through12,14,16 and25, and at or near theseal cap92 in FIGS. 3, 9,13, and15 through19. The term “distal” is used to denote the opposite end of the valve, or spike tip, or seal.
• As best shown in FIGS. 3 and 4, the first embodiment of the invention,[0308]valve10, includes a valve body orhousing12, aspike element24, and aseal36. Theseal36 is prepared from a resilient material that is flexible, inert, impermeable to fluid, and readily pierceable by thespike26. In th embodiment shown in FIG. 13 depicting an alternate shapedseal36d, thisseal36dhas aprecut slit211 in its proximal end. This provides a tiny orifice through which thetip32 of thespike element24 may easily pass, yet still provides a fluid tight seal upon withdrawal of the spike element. These three components are assembled, as depicted in FIG. 5, for example, with thespike lement24 enclosed to prevent accidental sticks. FIG. 4 illustrates how thehousing12,seal36, and spikeelement24 are attached without the need to use any adhesive or other bonding agent or process. Mechanical connection which provides a fluid tight closure is attained as is discussed subsequently. As shown in FIGS. 6 and 7, theseal36 moves within thehousing12, being pierced by thespike element24 to expose thetip32 ofth spike element24 to allow fluid to flow through thevalve10.
• Referring to FIG. 3, one preferred embodiment of[0309]housing12 has a bell-shapedskirt16 and an upper, preferably cylindrical,conduit20. Theskirt16 is integral with, and connected by anannular ring14, to theupper conduit20. Theskirt16 creates a shield for aninner conduit18 of thespike element24. Thisinner conduit18 is preferably cylindrical in shape, and slightly tapered.Inner conduit18 andupper conduit20 comprise aligned hollow tubes so thatinner conduit18 andupper conduit20 are in fluid communication with one another when thespike element24 pierces theseal36. There is anannular lip25 surrounding acircular opening25ain the top of the conduit20 (see FIG. 4).
• In the first embodiment, the[0310]upper conduit20 is adapted to receive th tip ornose48 of an ANSI standard syringe46 (see FIGS. 6 and 7). It is, however, contemplated that the outer diameter of theupper conduit20 can be of any size to accommodate the attachment of other connector devices thereto. Advantageously, the proximal end of theupper conduit20 can be equipped with a locking mechanism to facilitate locking of thevalve10 to a variety of connector devices. For example, referring to FIG. 3, lockingears22 near theproximal lip25 ofhousing12 are preferably provided such that thehousing12 can be locked into any compatible Luer-Lock device known to those with skill in the art. For example, referring to FIG. 19, conventional Luer-Lock threads180 can be provided on the outer diameter ofupper conduit20.
• Referring to FIG. 4, the[0311]spike element24 has at its distal end theinner conduit18 and at its proximal end ahollow spike26 which is integral with the inner conduit. Theinner conduit18 and spike26 present a continuous passageway for fluid during use. Anannular cuff28 on an intermediate portion of thespike element24 is integral with, and interconnects, theinner conduit18 and thespike26. As illustrated in FIG. 5, therim28aof thecuff28 abuts the underside of theinner ring14, and has anannular detent28bthat snaps into an annular groove14bin the underside of the ring. Thecuff28 serves two functions. First, it serves as an attachment device to the underside of theannular ring14. Second, it serves as a support and attachment device for theseal36.
• The[0312]hollow spike26 has a tapered conical shape, ending in a sharp, pointedtip32. Preferably, along the length of the spike are raised, protrudingridges30. These raisedridges30 extend from the surface of the spik preferably between 0.2 and 2.0 mm. Theridges30 are preferably aligned along the length of the spike as illustrated in FIG. 4. Theseridges30 serve to break any vacuum created when thespike26 is sealed as described hereinbelow. Modifications to the alignment and orientation of the ridges ar discussed hereinbelow in association with their function. Just distal thespike tip32, there is situated at least one longitudinal through-hole34 to permit fluid communication between theinner conduit18 and theupper conduit20. Preferably, there are three through-holes34 within about 0.200 inch fromth spike tip32. These through-holes34 may be of any size, however, the larger the size of the through-holes the greater the fluid flow rate through thevalv10. In a preferred embodiment, the size of the through-holes34 are 18-gauge to provide a flow rate three times that of a standard 18 gauge needle.
• The[0313]seal36 has aseal cap40 with a generally flattop surface40b, an outwardly taperedsidewall38, and alower lip42. Its interior is hollow to provide the conically shaped cavity37 (FIG. 5). Thus, theseal36 slips easily over thespike element24 to fit snugly within thecavity37. Theseal lip42 is seated within theannular cuff28 and wedged between the cuff and the underside of thering14. There are longitudinal grooves43 (FIG. 4) along the length of theseal36 which provide air pockets that facilitate compression of theseal36 during use. Thegrooves43 may be of variable shape or size to facilitate seal compression. In the first embodiment, there is asingle groov43 which completely surrounds theseal36 between theseal cap40 and thelip42.
• The base of the[0314]seal36 has a width such that theseal lip42 fits snugly into theannular cuff28. The hollow interior or cavity37 (FIG. 5) of theseal36 is preferably tapered to conform internally to the shape of thespike24, having awall portion44 which contacts thespike24distal seal cap40. Th exterior of theseal36 is sized and shaped to fit inside theupper conduit20 of thehousing12. Thecap40 reseals thevalve10 when thetop surface40bis above the through-holes34. Preferably, thecap40 substantially fills the opening25ain the top of theconduit20. Thus, after assembly, thetop surface40bof theseal cap40 is essentially flush with thelip25, so that thelip25 and seal cap 0.40 can be swabbed with alcohol or other disinfectant without leakage of disinfectant into thevalve10. It is important that thesurface40bbe exposed so that it may be swabbed with a disinfectant.
• FIG. 5 illustrates a first embodiment of a valve of the present invention that has been assembled using a first assembly method. The[0315]spike24, with contiguousinner conduit18, is affixed to thehousing12 through th association of the external portion ofannular cuff28 and theinner surface254 ofannular ring14. Specifically, theannular cuff28 forms a tight fit within theannular ring14, so that the force of friction between the external portion ofannular cuff28 and theinner surface254 of annular ring 1.4 secures the spike;24 inside thehousing12. This first method of assembly requires that sufficient force be applied to the distal end of thespike24 to overcome the force of friction between theannular cuff28 and theannular ring14, while holding thehousing12 in place, so that thespike24 slides toward the proximal end of thehousing12, until therim28aof theannular cuff28 abuts the underside of theannular ring14. Alternatively, thespike24 can be held in place, while thehousing12 is forced around the outside of thespike24. A person of skill in the art will know of numerous techniques by which this method can be accomplished. In addition, although not necessarily required, thespike24 may be affix d to thehousing12 by any one of a variety of additional measures known to those of skill in the art including, but not limited to, heat sealing, glue, pressure lock, bonding, or the like.
• Proper selection of the dimensions of the[0316]annular cuff28 and theannular ring14 will provide a fluid tight closure for-thevalve10. However, if the outside diameter of theannular cuff28 is too small relative to the inside diameter of theannular ring14, then, referring to FIG. 5, thespike24 may slip in a downward direction relative to thehousing12, which may cause thevalve10 to leak. On the other hand, if the outside diameter of theannular cuff28 is too large relative to the inside diameter of theannular ring14, then thehousing12 may crack, particularly when thevalve10 is used to conduct lipids, or other fats, which may cause theentire spike24 to expand. Although one of skill in the art will be able to determine appropriate dimensions for theannular cuff28 and theannular ring14, the present inventors have developed an improved method of assembling animproved valve11 of the present invention which will be described below. This improved valve and improved method of assembly will reduce the likelihood that a valve will either leak or crack, by securing thespike24 inside thebody12, without-requiring as much pressure between theannular cuff28 and theannular ring14.
• The[0317]seal36 fits into theannular cuff28 and is held in place by aninternal lip27 along the internal portion of theannular ring14 of thehousing12. The length of thespike24 is such that, after assembly, the tip of the spike rests below the plane defined by thelip25 of thehousing12. Preferably, thespike tip32 is approximately from 0.525″ to 0.1″ below thelip25 of thehousing12. Theseal36 fits snugly against thespike24 and is essentially flush with thelip25 of thehousing12. Thespike tip32 is thus embedded within theseal cap40 prior to use or may be approximately 0.025″ distal theseal cap40 when thevalve10 is in the closed position. Theinner conduit18ispartially shielded by the bell shapedskirt16 of the housing12 (see FIGS.3-5). Theinner surface254 of the bell shapedskirt16 preferably has protrudingthreads45 as an optional locking mechanism for attaching a medical implement thereto. Further, other medical devices can be pressure fit over the outer portion ofinner conduit18 without direct association with the protrudingthreads45.
• 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 valv is desired. During use, a connector of the appropriate size is fitted over the[0318]inner conduit18. Locking can be achieved by a Luer-Lock mechanism, a pressur fit or any other locking mechanisms known to those with skill in the art, as described above. Thus, in one example, fluid passes from theinner conduit18 into thespike26. However, fluid flow is locked in place by theseal36.
• FIGS. 6 and 7 illustrate valve activation. FIG. 6 illustrates a[0319]syringe22 connected to the proximal end of thevalve10. However, this connecting implement could be any number of medical implements known to those of skill in the art. Thenose28 of thesyringe22 is placed on theseal cap40 inside thelip25 of thehousing12. The application of pressure on thesyringe22 in the direction of the arrows, as illustrated in FIG. 6 creates pressure onseal cap40. The resulting downward pressure compresses theseal36. This pushes thetip32 of thespike26 through theseal cap40 to expose the through-holes34. Compression is facilitated by thegrooves38. Fluid is now able to flow into thesyringe22, or vice versa, depending on whether fluid is to be withdrawn from the patient or medication injected into the patient. FIG. 7 showsvalve10 opened by insertion of thenose28 of thesyringe22 into the opening25a. Asyringe plunger60 in thesyringe22 is retracted thereby creating a vacuum to draw fluid through thevalve10 into the syringe. For intravenous applications, thevalve10 can be orientated in the position diagramed in FIGS. 6 and 7, or it can be rotated 180° such that fluid flows in the opposite direction. Upon removal of the syringe fromspike26, as shown in FIG. 6, theseal36 is free to return to its original shape and cover through-holes34. The ability of theseal36 to return to its original shape is determined by the resiliency of the material used to prepare theseal36. In addition, the ability of theseal36 to return to its original shape is facilitated by the protrudingridges30 formed on the external surface of the spike. During compression, a vacuum may form in the area between thespike26 and theseal36, thereby preventing theseal36 from returning to its original position. The protruding ridges permit air to pass along the spike/seal interface to prevent vacuum formation and allow free return of the seal. The-ability of theseal36 to deform reversibly and return to its original position is particularly useful because (1) it immediately stops fluid flow through thevalve10, (2) it covers the recessedspike26 to maintain its sterility, and (3) it reduces the risk that the spike could inadvertently pierce another object or person. In addition, since thevalve10 lacks movable parts, except for the seal, it is unlikely that when theseal36 is pushed down, thevalve10 would fail to function.
• Advantageously, the through-[0320]holes34 are located relatively low on thespike26. Thus, the through-holes34 are sealed relatively early in the process as theseal36 returns to its original configuration when thevalve10 is closed. In one preferred embodiment the throughholes34 are located 0.075″ below the spike tip32 (see FIG. 4). Additionally, the through-holes34 are sealed even if theseal36 does not fully return to its original configuration depicted in FIG. 6. Further, the ability of theseal36 to return reversibly to its original position permits the reuse of theconnector valve10. Following disconnection, and before reuse, the surface ofpierced seal cap40 is essentially flush with thehousing12. Thus, this flush surface can advantageously be sterilized with alcohol or other surface decontaminating substances. Theskirt16 andupper conduit20 advantageously shield both connections from the surrounding environment to protect the sterility of the connection. Further, both theskirt16 andupper conduit20 function as collection reservoirs to prevent fluid from dripping from thevalve10 during manipulation.
• A cover cap (not shown) can be supplied to fit over the[0321]upper conduit20 as further protection for the seal surface between use. Such a cover cap, however, is not needed to maintain sterility since theseal36 may be swabbed with a disinfectant after each use. The reversibility of theseal36 makesth valve10 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 lin using the valve disclosed herein. The reversibility of thevalve10 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[0322]valve10 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. Thespike element24 is preferably prepared from the same material as thehousing12. 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, theupper conduit20 serves as a shield to thespike26 such that skin puncture is further reduced. Thespike26 need only be strong enough to penetrate theseal cap40, or if necessary, to pierce a connecting septum.
• In the embodiment of the invention illustrated in FIGS. 4 through 6, the through-[0323]holes34 are placeddistal spike tip32. This placement provides two important advantages. First, the placement of the through-holes34 facilitates resealing of thevalve10 after use. Second, if the through-holes were placed at thespike tip32, theholes34 may core theseal cap40 thereby introducing seal particulate into the fluid flow and possibly plugging theholes34. Thus, the longitudinal placement of the through-holesdistal spike tip32 prevents the introduction of particulates into the fluid path and/or plugging of the through-holes34. It is additionally contemplated that th number and diameter of the through-holes34 can be adjusted to accommodate different fluid velocities. In a preferred embodiment, the preferred velocity of fluid passing through the through-holes34 is equal to or greater than the flow rat through an18 gauge needle. Through-holes larger than 18 gauge will, f course, facilitate greater fluid velocities.
• An important advantage of the invention is that the[0324]valve10 has very little dead space, thus the volume of liquid entering into the valve is substantially equivalent to the volume6ffluid 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 asyringe22 is substantially zero.
• An alternative embodiment of the seal, a[0325]seal36a, is shown in FIG. 9.Seal36acomprises aseal cap92 at the proximal end thereof and aseal lip96 at the distal end
• thereof. A cup-like[0326]annular flange95 is providedproximal seal cap92. Theseal cap92 andseal lip96 are connected by a seal wall consisting of a plurality of ringedwall portions94 that expand and collapse in an accordion like fashion. During compression of theseal36a, the diameter of the ringedwall portions94 expand outward in the radial direction. There areair pockets13a(FIG. 10) betweenring portions94 and the housing andair pockets13bbetweenspike24 and seal36a. Theseal36acontains acavity98distal seal cap92 and adjacent the ringedwall portions94. Theseal36ainteracts with spike26 (FIG. 6) and other components of the present invention in a similar fashion to seal36 of FIG. 6.
• Referring to FIG. 10, the cup-like[0327]annular flange95 may be stretched around theupper conduit20 and held in place by anannular ring97. This creates a trampoline like effect that assists returning theseal36ato a decompressed state after withdrawal of a syringe (not shown). This embodiment has two advantages. First, the proximal end of thevalve10 can be swabbed with alcohol or other disinfectant without leakage of disinfectant into thevalve10. Second, by affixing cup-likeannular flange95 toupper conduit20 at the proximal end thereof withannular ring97, the repeated deformation and reformation of theseal36ais assisted.
• An alternative embodiment of the seal, a[0328]seal36bis shown in connection with thevalve10 in FIG. 11. Theseal36bis similar to theseal36aand Is comprised ofseal cap92, a side wall consisting of ringedwall portions94 and aseal lip96. It also has an outwardly extendingring99 which is at a right angle with respect to the longitudinal axis of thevalve10. Thisring99 is us d to attach theseal36btoupper conduit20. Preferably, an upper conduitannular plug20′ is inserted withinupper conduit20 to create a tight fit betweenperpendicular ring99, aledge101 in-theupper conduit20, and theplug20′. Thering99 assists in the-reformation ofseal36bto enclosespike26 upon withdrawal of a syringe (not shown).
• As shown in FIG. 12, the cup-like[0329]annular flange95 andring99 may both be used in connection with thevalve10, to provide the seal36c. This seal36c, provides rapid reformation upon withdrawal of a syringe (not shown) and realizes the advantages of both theseals36aand36b.
• Another alternative embodiment of the seal, a[0330]seal36d, is shown in FIG. 13. In this embodiment, theseal36dis comprised ofseal cap92,seal lip96, and aside wall150 comprised ofcircular tires100 stacked in series on on top of an adjacent larger diameter lower tire. Thecircular tires100 are preferably solid throughout the diameter of the cross-section thereof. Thesecircular tires100 will deform and reform upon, respectively, compression and decompression of theseal36d, thereby exposing or covering a spike (not shown) as the case may be.
• As mentioned above, preferably seal[0331]36dhas aprecut slit211 in thecap92 lying along the longitudinal axis of thevalve10. Theseal cap92 has a unique configuration that insures that theslit211 closes and is sealed upon withdrawal of a syringe (not shown) and reformation of theseal36dit includes an enlarged, internal, pressureresponsive member200 which is integral with thecap92. Between the proximal end of theside wall150 and themember200 is anannular space102 which is filled with the fluid in thecavity98. This fluid is under pressure, for example at the blood pressure of the patient to which thevalve10 is attached. Referring to FIG. 14, fluid, for example the patient's blood, flows through theholes34 in thespike26, filling thecavity102. This fluid presses against the exterior of themember200, closing theslit211 when the seal is decompressed as shown in FIGS. 14 and 19. The pressure from this fluid creates a high pressure seal which prevents fluid from escapingvalve10 through theslit211. There is a semi-cylindrical annularflange tear ring104 on the end of themember200 which advantageously extends the useful life ofseal36d.
• Preferably, there is a[0332]tear ring104 integral with themember200 along the perimeter of the internal surface of themember200, and a slight saucer-like depression204 in the external surface of the seal. The pressur responsive element in the decompressed state closes any orifice in theseal36dto provide an essentially fluid-tight seal while in the decompressed state. Th pressureresponsive member200 enables the valve to maintain a fluid-tight seal even at very high pressures sometimes experienced in medical applications, particularly when thevalve10 is connected to a patient's artery. The center of themember200 and theannular space102 are coaxial with theentryway211ato theorifice211. The pressurized fluid fills theannular space102 to apply pressure that compresses themember200 to tightly close the entryway to the orifice. In a preferred embodiment the distance from theentryway211ato the proximal end ofseal cap92 is from 0.500 to 0.075 inches and more preferably approximately 0.100 inch.
• As best illustrated in FIG. 22, the[0333]tip32 is designed to avoid tearing the seal.Tip32 has threefacets210,212, and214 which are joined with each other along parting lines a, b, and c. This junction of thefacets210,212, and214 frequently is ragged and will tear theseal36d. This is prevented by the parting lines a, b, and c, or junctions, being disposed within rec sses220,222, and224, respectively, to provide “buried parting lines.”
• Another alternative embodiment of the present invention using the[0334]seal36dis shown in FIG. 8 and FIGS. 19 through 21. In this embodiment, theinner wall160 of the upper end of theconduit20 is provided with at least one, and preferably, a plurality ofradial indentations107. Theindentations107 are elongated disposed generally parallel to the longitudinal axis of thevalve10 in a symmetrical, star-like configuration. Each indentation has opposedlateral edges162 which engage theseal36dupon compression of theseal36d. The indentations provide space into which theseal36dexpands upon compression.
• As best shown in FIG. 8, the[0335]wall181 of the proximal end of theconduit20 is tapered inward at the same angle as thenose28 of thesyringe22. In accordance with ANSI standards, the taper is 0.006 inch per linear inch. Thewall182 of thesyringe nose28 bears against thewall181 as the nose slides into the opening25ato push theseal36dinward compressing it and forcing thetip32 of thespike26 to enter theslit211. Theseal36dexpands upon compression to fill essentially completely the upper portions of theindentations107. Some sections of theseal36dare wedged between theedges162 and other sections fill theindentations107. As the liquid flows through thenose28 throughholes34, air in thenose28 is forced out of thenose28 and expelled fromvalve10 betweenwalls181 and182. Thus, essentially the entire prescribed dosage is delivered throughvalve10 to the patient. Fluid flows through the through-holes34, but does not leak betwe n either theseal36dand thewall181 or between the abuttingwalls181 and182.
• FIGS. 15, 16,[0336]17, and18 depict embodiments of seals, namely, seal36e, seal36f, and seal36g, which are substantially the same as theseals36a(FIG. 10), seal36b(FIG. 11), and seal36c(FIG. 12), except theside wall150 employing thecircular tires100 is used in place of theaccordion wall portion94.
• Other components of the present invention interact with the various embodiments of the seal in a similar fashion to their interaction with[0337]seal36 of FIG. 4. Prior to use ofvalve10, it is preferable that the seal caps40 or92 be pierced centrally by a steel needle in the axial direction, precutting the seal to provide theslit211 in order to allow for more rapid decompression and reformation of the seal upon piercing by thespike26. The seals are advantageously formed from a material which can repeatedly reseal and prevent fluid from flowing around the seal material. Theseal36 should also be capable of being forced down and then spring back into position to reseal the valve. Material that is too soft will reseal effectively; however, will not be capable of springing back after opening of the valve. Material that is too hard will provide sufficient spring force; however, will not effectively seal. Thus, in a preferred embodiment, the seal is formed from a silicone having a hardness in the range from 30-70 Shore durometer units, and more preferably in the range 40-50 Shore durometer units. A cure silicone polymer in the preferred hardness range is available from Wacker Silicone Corp. of Adrian, Mich. Preferably, silicone available from Dow Chemical Co. under the name DOW-595 is used. In some embodiments of the invention, it is desirable to provide additional lubricity to theseal36 to allow it to spring back and reseal more effectively. Dow Chemical Co. produces a silicone formulation with silicone oil built in to provide this additional lubricity. Preferably, however, X-15™ mineral oil is placed on theseal36 to lubricate it.
• In general, the closing of the[0338]valve10 is provided not by the side wall of theseal36 which immediately covers the through-holes34, but by theseal cap40, or sealcap92 filling the proximal end of thecavity98 and theopening25a. Thus, the seal caps40 and92 are sufficiently thick to reseal theopening25aeffectively after valve closure. However, the seal caps40 and92 should also be sufficiently thin to allow them to readily return to the closed position. Preferably the thickness of thecaps40 and92 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.[0339]
• FIG. 23 illustrates a body or[0340]housing12 of a tenth embodiment of the present invention, while FIG. 24 illustrates a body orhousing12 of an eleventh embodiment of the present invention. Thehousing12 of FIG. 23 or FIG. 24 is substantially similar tohousing12 described above in conjunction with FIG. 7. Thus, thehousing12 has a bell-shapedskirt16, aninner surface254, protrudingthreads45, aninner surface250, and further includes agouging surface252a. In FIG. 24 thegouging surface252ais illustrated as a ledge extending arcuately from theinner surface250, while in FIG. 23 thegouging surface252ais illustrated as a ledge extending at a slope from theinner surface250. Thehousing12 is specially designed for use with a second, and improved, method of assembly, described in more detail below. In particular, for the improved method of assembly described below, a portion of thegouging surface252apreferably has a smaller diameter than the effective diameter of the protrudingthreads45. As recognized by a person of skill in the art, other embodiments of thehousing12, with variations to thegouging surface252a, can be used with the improved method of assembly, or a functionally equivalent method, to provide an improvedmedical valve11, based on the following description of the improved valve and method.
• FIG. 25 illustrates the improved[0341]medical valve11 comprising thehousing12 of FIG. 23 (although thevalve11 could be made with thehousing12 of FIG. 24 equally well), thespike element24 of FIG. 7, and theseal36 of FIG. 7. An improvedmedical valve11 can also be created from thespike element24 and seal36 of any of the first nine embodiments. Thus, for example, an improvedmedical valve11 can be assembled using thehousing12 of FIG. 23, thespike element24 of FIG. 14, and theseal36dof any of FIGS.3-7,7 and9-19 to create a new, and preferred, embodiment. The improvedmedical valve11 is essentially similar tomedical valve10, described above, with the addition of retainingtabs252cfor securing thespike element24 and theseal36 inside thehousing12, and a variation in the interference fit between thespike element24 and thehousing12.
• Still referring to FIG. 25, the improved[0342]medical valve11 comprises aspike element24 and aseal36 mounted in thehousing12. Theseal lip42 of theseal36 is secured between theinternal lip27 of thehousing12 and theannular cuff28 of thespike element24 to secure theseal36 inside thehousing12. Theannular cuff28 of thespike element24 is secured against the underside of theseal lip42 of theseal36 by retainingtabs252cto secure thespike element24 and theseal36 inside thehousing12. The retainingtabs252cpreferably consist of a portion of the material that: before assembly, constituted either thegouging surface252aof FIG. 23 or FIG. 24. Thesetabs252cconstitute material from thegouging surface252awhich has been gouged away from its original position on thehousing12 and forced against the lower surface of theannular cuff28. The retainingtabs252car rigid enough to hold thespike element24 and theseal36 against the underside of theannular ring14 of thehousing12 and prevent leakage from the improvedmedical valve11. Thespike element24 is further prevented from removal fromhousing12 because of the annular,detent28bon theannular cuff28, which detent28bsnaps into the annular groove14bof theannular ring14.
• The securing force provided by the retaining[0343]tabs252creduces the need for friction or interference fit between the external portion ofannular cuff28 and theinner surface254 ofannular ring14, as described above with respect to the first method of assembly. Thus, the outside diameter of theannular cuff28 can be reduced relative to the inside diameter of theannular ring14, without allowing leakage to occur within themedical valve11. For example, it has been found that the outside diameter of theannular cuff28 can be as little as about 0.003″ larger than the inside diameter of thering14 and still provide a proper seal. The ability to reduce the diameter of cuff28 (in relation to the diameter of the ring14) reduces the possibility that thehousing12 will crack in response to hoop stress, even when thespike element24 expands because of the conduction of lipids, or other fats. Further, the lessened importance of providing exact tolerances between theannular cuff28 and theannular ring14 allows for variations in the materials and the manufacturing process of these components, reducing manufacturing costs.
• FIG. 26 shows a[0344]gouging bit262 and a base260 that are preferably used in the improved method of assemblingvalve11. Thegouging bit262 has acentral bore298 therethrough, agouging edge266 thereon, several guidingsurfaces292,294, and296, and a number ofribs297. Thebase260 includes ahole268. FIG. 27 shows a cross-sectional view of the tip of thegouging bit262. This FIGURE shows the several guidingsurfaces292,294, and296, theribs297, along with thebore298 and acontact surface276 to which theribs297 are connected.
• FIGS. 28, 29, and[0345]30 illustrate the use of thegouging bit262 and the base260 to perform the improved method to assemble animproved valve11 of the present invention. Referring to FIG. 28, aseal36 of FIG. 7 is placed onto aspike element24 of FIG. 7. Theinner conduit18 of thespike element24 is placed inside thebore298 in thegouging bit262. Thespike element24 can be retained inside thegouging bit262 by friction between the outer surface of theinner conduit18 of thespike element24 and the inner surface of thebore298 of thegouging bit262, or by other appropriate means.
• Preferably, the[0346]contact surface276 of thegouging bit262 contacts the upper surface of theannular cuff28 of thespike element24. It is noted that thegouging bit262 is sized such that thegouging edge266 extends beyond the outside perimeter of thespike element24, including theannular detent28b.
• The[0347]valve housing12 is placed inside of thehole268 located in thebase260, with the distal end of the housing111 protruding from thebase260. Once thegouging bit262 and the base260 are positioned so that their centers are in direct vertical alignment, thebase260 is moved upwardly, toward the gouging bit262 (although, as one skilled in the art will recognize, alternately, thebit262 may be moved downwardly towards the base260). As thebas260 approaches thegouging bit262, the base260 forces thehousing12 around the outside of thespike element24 and theseal36, so that thespik element24 and theseal36 penetrate thehousing12. Continued movement of the base260 causes thehousing12 to be pushed up around thespike element24 and theseal36 until the distal portion of theannular ring14 of thehousing12 makes contact with theannular cuff28 of thespike element24, as shown in FIG. 29.
• Referring again to FIG. 28, the inside diameter of the housing[0348]12 (including the threads45) is sufficiently large enough that when thehousing12 is pressed around the outside of thespike element24 and theseal36, theannular detent28bof thespike element24 passes by the protrudingthreads45 and the gouging surface.252aof the housing. Further, the inside-diameter of thehousing12 is sized such that thegouging edge266 of thegouging bit262 also do not contact thethreads45.
• However, the[0349]housing12 andbit262 are sized such that thegouging edge266 of thegouging bit262 does make contact with thehousing12 at thegouging surface252a. In this manner, thegouging edge266 of thegouging bit262 gouges a portion of thegouging surface252aaway from the inner surface of thehousing12. The portion of thegouging surface252athat is partially separated from thehousing12 is folded or crushed in towards the center of thegouging bit262 and down toward theannular cuff28 of thespike element24 between pairs ofribs297 by the guidingsurfaces292,294,296 to form a number of retainingtabs252c, as shown in FIGS. 29 and 30. At this point, thehousing12, thespike element24, and theseal36 have been assembled to form an improvedmedical valve11, with the retainingtabs252csecuring thespike element24 and theseal36 inside thehousing12. Thegouging bit262 can then be separated from thebase260, and the assembledmedical valve11 can be removed.
• The method described above is the preferred method of assembly for the improved[0350]medical valve11 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 FIGS. 26 and 27, the tip of the[0351]gouging bit262 comprises a number ofsurfaces276,266 and292,294, and296 that combine to perform three basic functions. First, thecontact surface276, which is preferably an annular surface having a diameter of less than the outer diameter of thebit262, presses against theannular cuff28 of aspike element24 to drive thespike element24 into thehousing12. Second, thegouging surface266 on thegouging bit262 scrapes a portion of thegouging surface252aof thehousing12 away from the remainder of the gouging surface. Specifically,gouging surface266 is created by the intersection ofsurfaces292 and294 of thegouging bit262 with theoutside surface291 of thegouging bit262 to form a relatively sharp edge at the perimeter of thegouging bit262. Third, thegouging bit262 folds the gouged material from the gouging surface toward the center of thegouging bit262 alongsurfaces292,294, and296. In order to perform this guiding function, surfaces292,294 and296 all preferably slope downwardly and inwardly towards thecontact surface276. Further, in order to create thick retaining tabs as opposed to a thinner retaining ring,ribs297 are used to guide and separate the gouged material. Eachrib297 thus partially extends from thegouging edge266 to the guidingsurface276. As illustrated,112ribs297 are advantageously used to create112 tabs.
• FIGS. 26 and 27 illustrate the presently preferred embodiment of the[0352]gouging bit262. However, a person of skill in the art can modify the design of thegouging bit262 in numerous ways without departing from the teachings of the present invention.
• Substantial force is required to drive the base[0353]260 toward thegouging bit262 with sufficient force to insert thespike element24 into thehousing12 and to gouge thegouging surface252aof thehousing12 and create the retaining tabs.252c. Preferably, therefore, this assembly is accomplished through use of amachine286. FIG. 31 illustrates the manually operatedpunch machine296 that is preferably utilized, along with thegouging bit262 and thebase260, to perform the improved method of assembly. Thepunch machine286 illustrated in FIG. 31 is well-known to a person of skill in the art, and merely incorporates thespecific bit262 andbase260 described above. When utilizing thismachine286, thegouging bit262 is positioned in thepunch machine286 so that it is in direct vertical alignment with thebase260. Again, theseal36 is placed over thespike element24, which is placed inside thegouging bit262. Thevalve housing12 is placed inside thebase260. Thepunch machine286 is operated by manually pulling down on ahandle280 to create rotational motion in anaxle282, which in turn creat s vertical motion in apiston284. The vertical motion of thepiston284 is th n communicated to thebase260. Thus, by thismachine286, a downward motion in thehandle280 is translated into an upward motion in the base260 with respect to astationary bit262.
• Movement of the[0354]piston284 pushes the base260 in which, thevalve housing12 is located upwardly until theannular cuff28 of thespike element24 contacts theannular ring14 of thehousing12. During this procedure, thegouging edge266 of thegouging bit262 gouges a portion of thegouging surface252aaway from the inner surface of thehousing12 to create the retainingtabs252c. A mechanical stop (not shown) is preferably used to prevent the base260 from being driven too far relative to thegouging bit262.
• After the components of the medical valve have been assembled, the[0355]handle280 is released and returned to its normal position as shown in FIG.31. At this time, thebase260 also returns to its normal position, also known in FIG. 31. The completedvalve11 is then removed from themachine286.
• Although FIG. 31 illustrates a manually-operated punch machine, a person of skill in the art will recognize that a wide variety of machines could be designed to implement the improved method of assembly, including an automated version of the[0356]machine286 described above.
• The[0357]valve10 or11 is used to provide a closed, patient access system for transferring a predetermined amount of medication from a remote source t the patient. Thevalve10 or11 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 theseal36d, for example, prevents any blood from leaking from the valve. The delivery end ornose28 of the medical implement (such as syringe22) is inserted into the valve as depicted in FIG. 8, pushing thenos28 against the seal to compress the seal sufficiently to allow thetip32 of thespike24 to pierce the seal and enter said delivery end. The predetermined amount of medication in its entirety may now be transferred through thenose28 into thevalve10 or11 and into the patient. Since thenose28 and seal36dengage in a manner so that thetip32 of thespike element24, upon piercing the seal, meets the seal to avoid formation of any dead space at the interface betweennose28 and theseal surface40b. Transfer directly through thevalve10 or11 of essentially the entire predetermined amount of medication from thesyringe22 to the patient, so that essentially none of said predetermined amount is collected in any dead space in the valve, is accomplished with this invention. Upon withdrawing thenose28 from thevalve10 or11 theseal36dreturns to the decompressed state to close the valve and maintain while in said decompressed state a fluid tight seal even at high pressures and after repeated uses.
• FIG. 32 illustrates the piercing[0358]element520 used in conjunction with the above-describedvalve10 or11. It is recognized that the piercingelement520 may be used in conjunction with any of the embodiments of thevalve10 or11 described above.
• In particular, in the preferred embodiment, the[0359]proximal end570 of the piercingelement520 has a number ofthreads588 located on the outside surface thereof for engagement with thethreads45 inside of thehousing12 ofvalve10 or11. Thesethreads588 may comprise standard threads, or, as shown, short wings for engaging thethreads45 of thehousing12. When theproximal end570 of the piercingelement520 is threadingly engaged with the distal end of thevalve10 or11, thevalve10 or11 and piercingelement520 form a fluid tight seal.
• It is also contemplated that the piercing[0360]element520 andvalve10 or11 may be made as a single element, wherein theconduit18 of thevalve10 or11 and the connection portion at theproximal end570 of the piercingelement520 comprise a continuous single conduit or element. In one version the piercing element520 (without threads thereon) may be connected to theconduit18 of thevalve10 or11 and be permanently affixed thereto. This may be done, for example, by fusing theconduit18 into the connecting portion of the piercing element or by any other means known to one skilled in the art. Alternatively, thespike24 may be formed as an extension of theproximal end570 of the piercingelement520.
• Method of Using the Alternate Embodiment[0361]
• In operation, the piercing[0362]element520 is preferably threaded into engagement with thehousing12 of thevalve10 or11. The penetratingportion532 of the piercingelement520 is then inserted through theseptum534 of thevial524. Lastly, as best illustrated in FIGS. 6 and 7, thenose28 ofsyringe22 is engaged with the proximal end of thevalve10 or11. Once thesyringe22 is engaged, a fluid conduit exists from thevial524 through the piercingelement520 andvalve10 or11 to thesyringe22, whereby fluid may be withdrawn into thesyringe22 from thevial524.
• Advantageously, the[0363]syringe22 may be disengaged from thevalve10 or11 at any time. Once disengaged, the fluid conduit is automatically closed by theseal36 in thevalve10 or11. This system allows later withdrawal of fluid with anothersyringe22, without the fear of contamination of the fluid in the vial between uses.
• Drip Bag Adaptor[0364]
• In another preferred embodiment of the invention, illustrated by FIGS. 33 and 34, a[0365]sterile adaptor311 is provided to function as a connector to a container315 (shown in phantom) of fluid. Fluid can thus be removed from or added to the fluid container.
• The[0366]adaptor311 is preferably made of any medically-inert material. In a preferred embodiment of theadaptor311, and especially where disposability is desired, theadaptor311 is constructed of rigid plastic. In other embodiments, however, and particularly where reusability is desired, theadaptor311 may be made of stainless steel or any other medically inert substance, to allow sterilization in an autoclave or similar device.
• FIG. 33 shows an[0367]adaptor311 having a generallycylindrical body314 with a proximal end and a distal end, and anadaptor spike312 located at the proximal end. Theadaptor spike312 will preferably penetrate the outer surface of aseal316 located on thecontainer315. Thespike312 may be of any size and shape, to accommodate a range of container and seal sizes. In a preferred embodiment of theadaptor311, shown in FIG. 33, thespike312 is generally cylindrical having a sharpened annular proximal end, and is approximately 1.375 inches long. Alternatively, thespike312 may be generally frustoconical in shape.
• A[0368]longitudinal channel313 leads from the proximal end of the spike to the distal end of theadaptor311, providing a route for fluid to flow through theadaptor311. Thechannel313 is typically cylindrical although it may also be slightly frustoconical to accommodate the change in diameter from the tip of thespike311 to the distal end of theadaptor311. In the preferred embodiment of theadaptor311, thechannel313 has a generally smooth interior surface, to facilitate the easy flow of fluid through theadaptor311.
• Near the distal end of the spike is preferably located a[0369]flange317, of a size and shape to sealably conform to the surface of theseal316. In this manner, thespike312 and flange317 s rve to first penetrate theseal316 and next mate with theseal316, preventing leakage of fluid from thecontainer315 around the outside surface of theadaptor311. In addition, theflange317 prevents theadaptor311 from entirely transversing theseal316.
• In one embodiment, shown in FIG. 33, strengthening[0370]ribs318 are provided between the distal end of theadaptor311 and theflange317. Theseribs318 provide rigidity to thebody314 and prevent unwanted bending or twisting of theadaptor311. In addition, theribs318 provide a griping surface for the fingers or hand of a user, facilitating easy insertion or removal of theadaptor311 through theseal316. In other embodiments, however, strengtheningribs318 may not be required. This is particularly so where the length of thebody314 is relatively small.
• The[0371]body314 may be of any length necessary to accommodate easy connection to thefluid container315. In particular, it is advantageous that thebody314 be long enough to provide the user an adequate gripping surface, to facilitate installation and removal of theadaptor311. In a preferred embodiment of theadaptor311, thebody314 is approximately 1.625 inches long.
• In one preferred embodiment of the[0372]adaptor311, shown in FIG. 33, the distal end of theadaptor311 is provided with alocking mechanism319 that, preferably comprises a Luer-Lock device or other locking device known to those of skill in the art. Thelocking mechanism319 is adapted to removably and sealably connect the distal end of theadaptor311 to amedical valve10 or11 as previously described.
• Alternatively, as shown in FIG. 34, the distal end of the[0373]adaptor311 can be provided with an integralmedical valve10 or11.
• The[0374]adaptor311 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[0375]adaptor311 coupled with avalve10 or11 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 themedical valve10 or11. Referring now to FIGS. 6 and 7, this action pushes thetip32 of thespike26 through theseal36, exposing the throughholes34 and thus bringing the IV tubing or other medical implement into fluid communication with the fluid in thebag315. The connection process is more extensively described above with reference to FIGS. 6 and 7.
• Y-Connector with Integral Valve[0376]
• Another embodiment of the present invention is shown in FIG. 35. A[0377]connector331 is provided to function as a conduit between either two or three fluid sources or receptacles. Theconnector331 has atubular body332, having a proximal and a distal end, and atubular branch335 located betwe n the proximal and distal ends. At the proximal end of thebody332 is provided anintegral spike element24 as previously described.
• The[0378]connector331 is preferably made of any medically inert material. Advantageously, theconnector331 may be made of a transparent material, allowing a user to see whether fluid is flowing therethrough. In one preferred embodiment of theconnector331, and especially where disposability is desired, the connector is constructed of rigid transparent plastic.
• A[0379]longitudinal channel334 runs through thebody332 from the proximal end to the distal end, providing continuous fluid communication from the throughholes34 of thespike element24 through theconnector331. Thechannel334 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 thespike element24 and the distal end of thebody332. Furthermore, in the preferred embodiment of theconnector331 thechannel334 has a generally smooth interior surface, to facilitate the flow of fluid through theconnector331.
• Toward the proximal end of the[0380]body332 is provided thetubular branch port335, which has alongitudinal channel336 located therethrough. Thechannel336 is in fluid communication with thechannel334 of themain body332, and is, like themain channel334, generally cylindrical in shape. In addition, thechannel336 preferably has a generally smooth interior surface.
• The[0381]spike element24 is preferably formed integrally with themain body332. To form a plastic body with a continuous through-channel (such as thebody332 of this connector331), an effective method of manufacture is to use a bore pin to manufacture theconnector331. Theconnector331 of the present invention has the advantage of easy manufacture at low cost. In addition, theconnector331 will be less bulky, and will have a lower weight, than a connector in which thespike element24 is formed separately and then mechanically attached.
• At a later time, before use, the[0382]seal36 andhousing12 of themedical valve10 or11 of other preferred embodiments can be placed over thespike element24 and attached by such means as were described earlier in the discussion of those embodiments.
• In use, the distal end of the[0383]body332 can be placed in fluid communication with flexible tubing (not shown) or another fluid transmitting device or medical implement. The end of thebranch port335 can be, like the distal end of thebody332, placed in fluid communication with a source of fluid or other fluid transmitting device or medical implement.
• The[0384]connector331 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 thetubular branch port335. The fluid receiver, such as a patient, is, in use, placed in fluid communication with the distal end of thebody332. In this manner, the first fluid flows from its source through thebranch port channel336 into themain channel334 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[0385]medical valve10 or11. Referring now to FIGS. 6 and 7, this action pushes thetip32 of thespike26 through theseal36, exposing the throughholes34 and thus bringing the syringe or other connector into fluid communication with theconnector331. The connection process is more extensively described above with reference to FIGS. 6 and 7. Once the second fluid has been introduced the y-connector (also known as a y-site or piggyback connector) can be disconnected and the seal closes thevalve10 or11.
• Hook Adaptor for Y-Connectors[0386]
• FIGS. 36, 37, and[0387]38 illustrate another embodiment of the present invention. Ahook adaptor351 is provided to function as a connector to-a standard piggyback or y-site (not shown). Thehook adaptor351 attaches to the piggyback or y-site, providing a stable fluid link to the piggyback or y-site that is not easily or accidentally disconnected.
• The[0388]hook adaptor351 is preferably made of any medically inert material. In a preferred embodiment of thehook adaptor351, and especially wh re disposability is desired, thehook adaptor351 is constructed of rigid plastic. In other embodiments, however, and particularly where reusability is desired, thehook adaptor351 may be made of stainless steel or any like substance, to allow sterilization in an autoclave or similar device.
• As shown in FIG. 36, the[0389]hook adaptor351 has a generally cylindricaltubular body354 with a proximal end and a distal end, with anadaptor housing355 and spike356 at or near the distal end. In addition, ahook357 leads downward and away from thehousing355, to rotatably and removably engag an arm of the y-site when thehook adaptor351 is placed in fluid communication with the y-site, thereby providing a stable and not easily disconnected link.
• Referring to FIG. 36, the[0390]housing355 has a depth, defined by th distance from the distal end of theoutside wall358 of the-housing355 to thebase359 of thehousing355, sufficient to envelop a substantial portion of the end of the branch port of the piggyback or y-site connector. In the preferred embodiment of thisadaptor351, thehousing355 is approximately 0.375″ deep.
• The[0391]housing355 may furthermore have asection352 removed from a portion of the distal end of thehousing wall358, to accommodate the arm of the piggyback connector when theadaptor351 is in the connected and locked position (see discussion below).
• Centrally located within the[0392]housing355 is aspike356. Thespike356 is tubular, having anarrow channel353 running longitudinally therethrough, providing a route for fluid to flow through thespike356 and into thebody354 of theadaptor351. Thespike356 will preferably penetrate a septum located on the end of the branch port. Thespike356 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 thehousing355, so that the end of the spike does not substantially protrude beyond thedistal end358 of thehousing355. This prevents a user from accidentally sticking himself or herself with thespike356. In a preferred embodiment of theadaptor351, shown in FIG. 36, thespike356 is generally cylindrical having a sharpened annular proximal end, and is approximately 0.37 inches long. Alternatively, thespike356 may be generally frustoconical in shape.
• The[0393]spike356 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 asufficient channel353 for fluids, especially liquids, to pass easily therethrough. In particular, it is contemplated that theadaptor351 may be repeatedly connected to, and removed from, the same connector.
• The[0394]longitudinal channel353 is typically cylindrical although it may also be slightly frustoconical to accommodate the change in diameter from the tip of thespike356 to thebase359 of thehousing355. In the preferred embodiment of theadaptor351, thechannel353 has a generally smooth interior surface, to facilitate the easy flow of fluid through theadaptor351.
• The[0395]body354 may be of any length necessary to accommodate easy connection to the piggyback connector. In particular, it is advantageous that thebody354 be long enough to provide the user an adequate gripping surface, to facilitate installation and removal of theadaptor351. In a pr ferred embodiment of theadaptor351, thebody354 is approximately 0.41 inches long, measured from thebase359 of thehousing355 to the proximal end of thebody354.
• In one preferred embodiment of the[0396]adaptor351, shown in FIG. 36, the proximal end of theadaptor351 is provided with alocking mechanism360 that preferably comprises a Luer-Lock device or other locking device known to those of skill in the art. Thelocking mechanism360 is adapted to removably and sealably connect the proximal end of theadaptor351 to amedical valve10 or11 as previously described.
• Alternatively, as shown in FIG. 38, the proximal end of the[0397]adaptor351 could be provided with an integralmedical valve10 or11.
• The[0398]hook357 is of a size and shape to rotatably engage an arm of the y-site. Thehook357 preferably leads downward from thehousing355 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 theadaptor351 shown in FIGS. 36 and 38, thehook357 declines from thehousing355 at an angle of approximately 27°, and is approximately 0.5 inches long. The interior bend of thehook357 should be of a radius to accommodate the arm of the y-site, and is in the shown preferred embodiment approximately 0.11 inches in radius.
• In use, the[0399]housing355 of theadaptor351 is placed over the end of the branch port of the y-site, and then pressed down until thespike356 penetrates the septum on the branch port, providing fluid communication between theadaptor351 and the y-site. Theadaptor351 is then rotated until thehook357 engages the arm of the y-site, firmly holding theadaptor351 onto the y-site, and preventing accidental disconnection of theadaptor351. To remove theadaptor351, a user merely rotates thehook357 in the opposite direction, disengaging thehook357 from the y-site.
• If using an[0400]adaptor351 of the type shown in FIG. 36, amedical valve10 or11 of the first preferred embodiment can be attached to the proximal end of theadaptor351, using thelocking mechanism360.
• 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[0401]medical valve10 or11. Referring now to FIGS. 6 and 7, this action pushes thetip32 of thespike26 through theseal36, exposing the throughholes34 and thus bringing the syringe or other connector into fluid communication with theadaptor351. The connection process is more extensively described above with reference to FIGS. 6 and 7.
• Snap-On Adaptor for Piggyback Connector[0402]
• Another embodiment of the present invention is shown in FIGS. 39, 40, and[0403]41. A snap-onadaptor371 is provided to function as a connector to a standard medical y-site. The snap-onadaptor371 attaches to the branch port or another arm of the y-site, providing a stable fluid link to the y-connector361 that is not easily or accidentally disconnected.
• The snap-on[0404]adaptor371 is preferably made of any sterile, medically inert material. In addition, the material should be capable of slight elastic deformation, to allow theadaptor371 to “snap” into position (see description of use, below). In the preferred embodiment of the snap-onadaptor371, and especially where disposability is desired, theadaptor371 is constructed of rigid plastic. In other embodiments, however, and particularly where reusability is desired, theadaptor371 may be made of stainless steel or any like substance, to allow sterilization in an autoclave or similar device.
• As shown in FIG. 39, the snap-on[0405]adaptor371 has a generally cylindricaltubular body374 with a proximal end and a distal end, and anadaptor housing375 and spike376 at the distal end.
• The[0406]adaptor housing375 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. Thehousing375 wall has anopening372, shaped to closely accommodate the branch port or arm of th piggyback connector when theadaptor371 is connected to the y-site.
• The[0407]opening372 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 theadaptor371 as shown in FIG. 39, theopening372 has a rounded proximal end, to accommodate the radius of the protruding branch port or arm of the y-site when theadaptor371 is connected to the y-site. In a preferred embodiment of theadaptor371, theopening372 is approximately 0.22 inches wide, and rounded at one end with a 0.11 inch radius.
• Toward the[0408]distal end378 of thehousing375, theopening372 narrows sharply and then gradually widens, so that a pair of opposing and spaced aparttabs377a,377bare formed, integral with thehousing375. Thetabs377a,377bare 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 theadaptor371, thetabs377a,377bare spaced apart by approximately 0.09 inches.
• The[0409]opening372 gradually widens from thetabs377a,377btoward the distal end of thehousing wall378, thus providingentrance bearing surfaces373a,373bwhich assist in guiding an arm of the y-site into theopening372. In the preferred embodiment of theadaptor371 shown in FIGS. 39 and 41, theentrance bearing surfaces373a,373bdecline from the horizontal at an angle of approximately 40°.
• Centrally located within the[0410]housing375 is thespike376. Thespike376 is tubular, having anarrow channel381 running longitudinally therethrough, providing a route for fluid to flow through thespike376 and into thebody374 of theadaptor371. Thespike376 will preferably penetrate a septum located on a branch port of a y-site. Thespike376 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 thehousing375. This prevents a user from accidentally sticking himself or herself with thespike376. In a preferred embodiment of theadaptor371, shown in FIG.39, thespike376 is generally cylindrical having a sharpened annular proximal end, and is approximately 0.5 inches long. Alternatively, thespike376 may be generally frustoconical in shape.
• The[0411]spike376 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 asufficient channel381 for fluids, especially liquids, to pass easily therethrough. In particular, it is contemplated that theadaptor371 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 theadaptor371, thespike376 is only about 0.05 inches in diameter.
• The[0412]longitudinal channel381 is typically cylindrical although it may also be slightly frustoconical to accommodate the change in diameter from the tip of thespike376 to thebase379 of thehousing375. In a preferred embodiment of theadaptor371, thechannel381 has a generally smooth interior surface, to facilitate the easy flow of fluid through theadaptor371.
• The[0413]body374 may be of any length necessary to accommodate easy connection to the y-site. In particular, it is advantageous that thebody374 be long enough to provide the user an adequate gripping surface, to facilitate installation and removal of theadaptor371. In the preferred embodiment of theadaptor371, thebody374 is approximately 0.3 inches long, measured from thebase379 of thehousing375 to the proximal end of thebody374.
• In one preferred embodiment of the[0414]adaptor371, shown in FIG. 39, the proximal end of theadaptor371 is provided with alocking mechanism382 that preferably comprises a Luer-Lock device or other locking device known to those of skill in the art. Thelocking mechanism382 is adapted to removably and sealably connect the proximal end of theadaptor371 to amedical valve10 or11, as previously described.
• Alternatively, as shown in FIG. 41, the proximal nd of the[0415]adaptor371 could be provided with an integralmedical valve10 or11.
• In use, the[0416]housing375 of theadaptor371 is placed over the end of the branch port of the y-site, and then advanced so that thespike376 pierces the septum on the branch port. A deliberate force must be applied so that the arm of the y-site passes through thetabs377a,377band into theopening372. Constant pressure on theadaptor371 thus causes the arm of the y-site to snap into the opening, and contemporaneously thespike376 penetrates the septum, providing fluid communication between the y-site andadaptor371.
• To remove the[0417]adaptor371, the user must deliberately pull theadaptor371 off the y-site.
• If using an[0418]adaptor371 of the type shown in FIG. 39, amedical valve10 or11 of the first preferred embodiment may be attached to the proximal end of theadaptor371, using thelocking mechanism382.
• The tip or nose of an ANSI standard IV set, syringe, or other connector, is then pushed into the proximal end of the[0419]medical valve10 or11. Referring now to FIGS. 6 and 7, this action pushes thetip32 of thespike26 through theseal36, exposing the throughholes34 and thus bringing the syringe or other connector into fluid communication with theadaptor371. The connection process is more extensively described above with reference to FIGS. 6 and 7.
• Test Tube Adaptor[0420]
• FIGS. 42 and 43 illustrate yet another embodiment of the present invention. A[0421]test tube adaptor391 is provided to function as a device for withdrawing fluid from, or depositing fluid into, a test tube or other narrowly necked container. Thetest tube adaptor391 either attaches to amedical valve10 or11 as previously described, as shown in FIG. 42; or is a single piece having an integralmedical valve10 or11, as shown in FIG. 43.
• The[0422]test tube adaptor391 is preferably made of any medically inert material. In the preferred embodiment of thetest tube adaptor391, and especially where disposability is desired, thetest tube adaptor391 is constructed of plastic. In other embodiments, however, and particularly where reusability is desired, thetest tube adaptor391 may be made of stainless steel or any like substance, to allow sterilization in an autoclave or similar device.
• As shown in FIG. 42, the[0423]test tube adaptor391 has a generally cylindricaltubular body394 with a proximal and a distal end, and an open-endedtube395 at the distal end.
• The[0424]tube395 is preferably flexible, and transparent, so that a user can see whether fluid is flowing therein. In the preferred embodiment thetube395 is constructed of flexible medical tubing. In addition, thetube395 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 preferr d embodiment, thetube395 is approximately 5.5 inches long. Thetube395 should also have an inner diameter sufficient to allow fluids, especially liquids, to pass easily therethrough. In the preferred embodiment, thetube395 has an inner diameter of approximately 0.03 inches.
• The[0425]body394 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 thetube395 is attached.
• In one preferred embodiment of the[0426]adaptor391, shown in FIG. 42, the proximal end of theadaptor391 is provided with a locking mechanism392 that preferably comprises a Luer-Lock device or other locking device known to those of skill in the art. The locking mechanism392 is adapted to removably and sealably connect the proximal end of theadaptor391 to amedical valve10 or11, as previously described.
• Alternatively, as shown in FIG. 43, the proximal end of the[0427]adaptor391 could be provided with an integralmedical valve10 or11.
• In use, the[0428]tube395 of theadaptor391 is placed into the test tube or other container. If using anadaptor391 of the type shown in FIG. 42, amedical valve10 or11 of the first preferred embodiment must be attached to the proximal end of theadaptor391, using the locking mechanism392. The tip or nose of an ANSI standard syringe, IV set, or other connector, is then pushed into the proximal end of themedical valve10 or11. Referring now to FIGS. 6 and 7, this action pushes thetip32 of thespike26 through theseal36, exposing the throughholes34 and thus bringing the syringe into fluid communication with theadaptor391 and the test tube. The valve connection process is more extensively described above with reference to FIGS. 6 and 7.
• 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 describ d. It will be appreciated that certain modification and variations may sugg st themselves to those skilled in the art. The spirit and scope of the invention are limited solely by the following claims.[0429]

Claims (37)

1. A device used for accessing fluid in the interior of a vial through a pierceable seal located on the vial, and to facilitate the transfer of said fluid into a syringe, comprising:

a piercing element having an exterior surface, an interior bore, a distal end and a proximal end, said distal end comprising a point and having at least one hole at or near said point in fluid communication with said bore, said proximal end comprising a connecting piece adapted to connect the device to a syringe; and

a locking structure projecting outward from the exterior surface of said piercing element, whereby said locking structure permits penetration of the pierceable seal by said piercing element, but prohibits withdrawal of the piercing element back through the pierceable seal.

2. The device ofclaim 1, further comprising a stop which limits penetration of said piercing element into the interior of said vial.

3. The device ofclaim 2, wherein said stop comprises a round disk located proximal said hole in said piercing element.

4. The device ofclaim 2, wherein said stop comprises a tab extending laterally from said piercing element and located proximal said hole in said piercing element.

5. The device ofclaim 1, wherein said locking structure comprises at least one barb.

6. The device ofclaim 5, wherein the barb extends at a 45° angle away from the exterior surface of said piercing element.

7. The device ofclaim 1, wherein the connecting piece is adapted to form a substantially fluid-tight seal with said syringe.

8. A method of accessing and transferring fluid inside a vial through a pierceable seal on the vial, comprising:

connecting a syringe to a piercing element, said piercing element having an exterior surface, an interior bore, a distal point and at least one hole at or near said point in fluid communication with said bore, and a locking structure projecting outward from the exterior surfac of said piercing element, whereby said locking structure permits penetration of the pierceable seal by said piercing element, but prohibits withdrawal of th piercing element back through the pierceable seal;

piercing said pierceable seal with said piercing element;

inserting said piercing element into the vial until said hole in said piercing element contacts the fluid inside the vial;

withdrawing a desired amount of fluid through the internal bore in said piercing element and into the syringe; and

separating the syringe from the piercing element, such that the locking structure on the piercing element prohibits the withdrawal of the piercing element through said pierceable seal.

9. The method ofclaim 8, wherein said inserting step is performed prior to said connecting step.

10. The method ofclaim 8, further comprising connecting a second syringe to said piercing element, and repeating said withdrawing and separating steps.

11. The method ofclaim 8, wherein said syringe forms a substantially fluid-tight seal with said piercing element.

12. A locking cannula for advancing through a pierceable seal and resisting retraction therefrom, comprising:

a housing;

a piercing element on said housing; and

a locking structure connected to said housing for advancing through a seal and resisting retraction therefrom.

13. The cannula ofclaim 12, wherein said locking structure extends from said piercing element.

14. The cannula ofclaim 13, wherein said locking structure comprises one or more barbs.

15. The cannula ofclaim 14, wherein said barbs are angled with respect to said piercing element to facilitate advancement of said cannula through said seal.

16. The cannula ofclaim 12, wherein said housing further comprises a stop.

17. The cannula ofclaim 16, wherein said locking structure extends from said stop.

18. The cannula ofclaim 16, wherein said stop is a primarily disc shaped structure extending from said housing.

19. The cannula ofclaim 12, wherein said housing includes a syringe-connecting structure located opposite said piercing element.

20. The cannula ofclaim 12, wherein said housing has a bore therein and said piercing element includes a hole passing from an outside surface thereof and connected to said bore, whereby a fluid conduit is formed from the outside of said piercing element through said housing.

21. A connector for accessing fluid in a vial, comprising:

a piercing element having a proximal end and a distal end, said element having a bore therethrough and said distal end comprising a point for penetrating a seal on said vial; and

a valve, said valve having a proximal end and a distal end, said distal end designed for connection to said proximal end of said piercing element, said valve further including a spike and a seal.

22. The connector ofclaim 21, wherein said proximal end of said piercing element comprises a housing having a bore therein, and said distal end of said valve comprises a connecting portion having a bore therein and sized for insertion into said proximal end of said piercing element.

23. The device ofclaim 21, further comprising a stop which limits penetration of said piercing element into the interior of said vial.

24. The device ofclaim 23, wherein said stop comprises a round disk located proximal said hole in said piercing element.

25. The device ofclaim 23, wherein said stop comprises a tab extending laterally from said piercing element and located proximal said hole in said piercing element.

26. The device ofclaim 21, wherein said locking structure comprises at least one barb.

27. The device ofclaim 26, wherein the barb extends at a450 angle away from the distal point of said piercing element.

28. The device ofclaim 21, wherein the connecting piece is adapted to form a substantially fluid-tight seal with said syringe.

29. The device ofclaim 21, wherein said proximal end of said valve is adapted for connection to a syringe.

30. The device ofclaim 21, wherein said valve includes a housing having a bore therein in which said spike and seal are located.

31. The device ofclaim 30, wherein the distal end of said housing is threaded on an interior surface thereof and said proximal end of said piercing lement is threaded for engagement with said threads in said housing.

32. A multiple use connector for accessing fluid in a vial with a syringe, comprising:

a member having a proximal end and a distal end, said distal end comprising a piercing element for penetrating a seal on said vial, and wherein said member includes a seal and a spike located within a housing portion of said member, said housing portion located between said proximal and distal ends.

33. A medical valve adaptor for use with containers of fluid, 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 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

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.

34. A medical three-way valved connector for use with containers of fluid, said valved connector comprising:

a first body having proximal and distal ends, and a cavity therein;

a spike located within said cavity-and attached to said 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

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.

35. 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

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.

36. 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

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.

37. A medical valve adaptor for use with narrowly necked fluid containers, 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

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.

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