Patent Grant
9989177
The present invention relates to filling devices and connectors, and methods of filling and transferring fluids, and more particularly to methods of aseptically filling devices and connectors for the aseptic filling and transfer of fluids.
A typical previously-known filling cannula or probe used for aseptic or so called “sterile” filling comprises a hollow filling tube including an outlet port in fluid communication between the hollow interior of the filling tube and ambient atmosphere. A previously-known filling cannula or probe, for example, includes a hollow stainless steel shaft, a bulbous tip fixedly secured to the distal end of the shaft, and diametrically opposed outlet ports proximal to the tip and in fluid communication between the interior of the shaft and the ambient atmosphere. One drawback encountered with previously-known filling cannulas and needles is that the interior of the cannula or probe, and any fluid contained therein or passing therethrough, can be exposed to the ambient atmosphere via the open fluid ports. In connection with known filling machines, regulatory agencies require control of the cannula or probe environment in order to protect against exposure of a sterile product to the environment and the resulting contamination of the product that might occur. However, typical controlled environments, such as a class 100 (ISO-5) controlled environment, are not truly sterile. Although the likelihood of contamination in such reduced-contaminant environments may be relatively low, just one colony of contaminants can develop into a container full of germs over its shelf-life. This risk is exacerbated when filling traditional open containers that are thereafter sealed in an assembly machine. No such previously-known assembly machine, such as, for example, a typical machine closing 40,000 containers per hour, can fully prevent entrance of viables and non-viables into the containers. On the other hand, if the cannula or probe is used to dispense a contaminated fluid, or a fluid that might be harmful if it is exposed to or comes into contact with an operator, the open ports can allow such fluid to contaminate its ambient atmosphere or potentially harm the operator that contacts the cannula or probe or is in the vicinity thereof.
A typical fluid connector includes a male connector that is received within a female connector to place the two connectors in fluid communication with each other. The male and female connectors may be threadedly engaged, snap fit, or otherwise releasably connected to each other to allow for interconnection and disconnection. Each connector is coupled in fluid communication with a respective fluid passageway, such as a tube or fluid chamber, in order to place the fluid passageways in fluid communication with each other and allow the passage of fluids through the connected elements.
Such fluid connectors typically do not prevent the contamination of fluids passing through them, unless the connector is sterile handled and connected in a relatively low challenging environment (even then, the connectors must be sealingly connected to each other to prevent ingress of contaminants, which means the connection cannot be disengaged). For example, prior to interconnection of the male and female connectors, the fluid-contacting surfaces thereof can be exposed to the ambient atmosphere and contaminated through contact with airborne germs and/or by contact with contaminated surfaces. One approach to preventing such contamination is to wipe the fluid-contacting surfaces of the male and female connectors with an alcohol wipe or other disinfectant prior to interconnection. One drawback of this approach is that the fluid-contacting surfaces may become contaminated after the wipe is applied to the male and female connectors. Another drawback of this approach is that it can be time consuming and considered a nuisance, and therefore unreliable in practice. There is no previously-known connector capable connection within a contaminated liquid or contaminated aerosol chamber that prevents the contamination of fluids passing therethrough.
Accordingly, aseptic or sterile fluids can be subjected to contamination when passed through such previously-known connectors. If used in a hospital or other medical facility, such as to transfer sterile drugs or other fluids intended for intravenous injection, for example, any such contamination can lead to bloodstream infections, e.g., catheter related blood stream infections (CRBSI). CRBSI represent about 15% of nosocomial infections per year. According to the Center for Disease Control (CDC), approximately 200,000 cases CRBSI are reported in the United States per year and cost the country about $35 billion in treatment costs. CRBSI leads to about 30,000 deaths per year in United States hospitals. In food processing applications, on the other hand, it may be necessary to connect fluid conduits, for example, in order to transfer sterile or aseptic fluids from one passageway to another. If the fluids are contaminated upon passage through a fluid connector, this can lead to contamination of previously-sterile food products, and if such contaminated products are ingested, they can cause infections and/or illnesses. In industrial applications, it may be necessary to prevent a toxic fluid passing through a connector from contaminating the ambient atmosphere, an operator handling the connector, and/or other surfaces that might be located external to the connector. If the fluid-contacting surfaces of the connector are exposed to human contact, or surfaces that come into human contact, for example, this can lead to possible injury and/or illnesses. For example, operators exposed to the transfer of liquids such as immune suppressants or hormones, can suffer from pulmonary absorption of such products.
It is an object of the present invention to overcome one or more of the above-described drawbacks and/or disadvantages of the prior art, including to reduce the risk of contamination of a fluid during transfer and/or filling thereof, and mitigating illness and death from nosocomial infections.
In accordance with a first aspect, a device comprises a tube including a flow inlet, a flow outlet in fluid communication with the flow inlet, and a closure; wherein at least one of the closure and the tube is movable between (i) a first position where the closure closes the flow outlet, and (ii) a second position where the flow outlet is open. To prevent contamination, the closure forms a substantially fluid-tight seal between the flow outlet and ambient atmosphere.
In some embodiments, the closure is biased in a direction from the second position toward the first position to normally close the flow outlet. In some such embodiments, the device includes a spring biasing the closure in the direction from the second position toward the first position.
In some embodiments, the tube is connectable to a device for filling, having a valve connected to a chamber thereof, where in the second position, the flow outlet is connectable in fluid communication with the chamber through the valve to fill substance from the flow inlet, through the flow outlet and valve, and into the chamber. In some such embodiments the device for filling includes a septum overlying the valve, and the closure is engageable with the septum to allow movement of at least one of the tube and closure relative to the other from the first position to the second position during or after movement of the tube through the septum. In some such embodiments, the valve includes a recess, the tube includes a tip that is receivable within the recess, and the closure is engageable with the device to be filled to allow movement of at least one of the tube and closure relative to the other from the first position to the second position during or after movement of the tube tip into the recess. In some such embodiments, he valve includes a spring that normally biases the valve in the direction from the open position to the closed position. In some such embodiments, the valve spring is approximately dome shaped.
In accordance with another aspect, a device comprises first means for the flow of substance to be filled therethrough; second means in fluid communication with the first means for the passage of the substance from the first means therethrough; and third means for opening and closing the third means, wherein at least one of the first means and the third means is movable between (i) a first position where the third means closes the second means, and (ii) a second position where the second means is open.
In some embodiments, the first means is a tube, the second means is a flow outlet of the tube, and the third means is a closure.
In some embodiments, the device further comprises fourth means for biasing the third means in a direction from the second position toward the first position to normally close the second means.
In accordance with another aspect, a method comprises the following steps:
In some embodiments the cannula further includes a tube defining an inlet and the outlet, and a closure, wherein the step of opening further comprises moving at least one of the closure and the tube between (i) a first position, where the closure closes the outlet, and (ii) a second position wherein the outlet is open. In some such embodiments, the method further comprises sealing the outlet from ambient atmosphere in the first position. In some such embodiments the method further comprises passing the cannula through a septum coupled to a valve in fluid communication with the storage chamber, engaging the valve, and introducing the aseptic or sterile substance from the outlet of the cannula through the valve. In some such embodiments, the engaging step further comprises opening the valve to allow the introduction of substance through the valve and into the storage chamber. In some such embodiments the step of opening the valve comprises moving a flexible valve member of the valve from a sealingly closed position to an open position.
In some embodiments, the method further comprises disengaging the cannula from the valve; and before or during the disengaging step, moving at least one of the closure and the tube from the second position to the first position, and simultaneously moving the valve from the open position to the sealing closed position.
In some embodiments, contact is substantially prevented between the outlet of the cannula and the septum during the engaging and disengaging steps. In some such embodiments, the closure is interposed between the outlet of the cannula and the septum to substantially prevent any contact between the outlet and the septum.
In some embodiments, the method further comprises engaging, introducing and disengaging steps in a non-sterile environment or an environment defining a SAL of about 6 log bio-burden on the surface or less; introducing a sterile fluid through the cannula and into the storage chamber; and maintaining the sterility of the filled fluid throughout the engaging, introducing and disengaging steps.
In accordance with another aspect, a connector comprises a first connector portion including a filling member comprising a hollow shaft, a tip formed at one end of the shaft, at least one port in fluid communication with an interior of the hollow shaft, and a closure; wherein at least one of the closure and the shaft is movable between (i) a first position wherein the closure closes the at least one port, and (ii) a second position opening the at least one port. The connector further includes a second connector portion adapted to engage the first connector portion and including a valve, which can have a flexible valve member and a valve seat configured to be moved between (i) a closed position, wherein the flexible valve member is sealingly engaged by the valve seat, thereby preventing the flow of fluid therethrough, and (ii) an open position, wherein the flexible valve member is disengaged from the valve seat to allow the flow of fluid therethrough; wherein at least one of the first connector portion and the second connector portion is moveable relative to each other between (i) a disconnected position wherein the at least one of the closure and the shaft is in the first position and the valve is in the closed position and (ii) a connected position wherein the filling member has engaged and moved the valve from the closed position to the open position and the at least one of the closure and the shaft is in the second position opening the at least one port.
In some embodiments, the closure forms a substantially fluid-tight seal between the at least one port and the ambient atmosphere in the first position.
In some embodiments, the closure is normally biased in the direction from the second position toward the first position to normally close the at least one port.
In some embodiments, the flexible valve member is normally biased in the direction from the open position toward the closed position, to normally sealingly close the valve from the passage of fluid therethrough.
In some embodiments, the first connector portion further includes a biasing member normally biases the closure in the direction from the second position to the first position. In some such embodiments, the biasing member includes a sealing member for sealing engaging the hollow shaft of the filling member. In some such embodiments, the sealing member is integrally formed with the biasing member. In some such embodiments, the sealing member comprises an O-ring. In some embodiments, the biasing member is an approximately dome-shaped elastic spring.
In some embodiments, the flexible valve member comprises an integral spring that normally biases the flexible valve member in the direction from the open position toward the closed position, to normally sealingly close the valve from the passage of fluid therethrough. In some such embodiments, the integral spring is an elastic approximately dome-shaped spring.
In some embodiments, the first connector portion further includes a one-way valve. In some such embodiments, the one-way valve is configured to vent out air from a chamber defined by dome shaped spring biasing member to the ambient atmosphere, when the at least one of the closure and the shaft is moved from the first position to the second position. In some such embodiments, the one-way valve is configured to vent in air from the ambient atmosphere into the chamber defined by the dome shaped spring biasing member, when the at least one of the closure and the shaft is moved from the second position to the first position. In some such embodiments, the one-way valve is integrally formed with the approximately dome shaped spring biasing member.
In some embodiments, the second connector portion further comprises a septum overlying the flexible valve member of the valve. In some such embodiments, the septum defines a durometer within the range of about 5 Shore A to about 65 Shore A. In some such embodiments, the septum defines a durometer within the range of about 25 Shore A to about 45 Shore A. In some such embodiments, the septum defines a thickness within the range of a thickness equivalent to about ½ the diameter of the filling member to a thickness equivalent to about double the diameter of the filling member.
In some embodiments the closure is engageable with the septum of the second connector portion to prevent further movement of the closure relative to the second connector portion, whereby subsequent movement of the first connector portion moves the shaft from the first position to the second position.
In some embodiments, movement of one of the first connector portion and the second connector portion relative to the other of the first connector portion and the second connector portion from the disconnected position to the connected position achieves at least approximately a 3 log reduction in bio-burden.
In some embodiments, at least one of the closure and the shaft is movable from the second position to the first position, and the valve is movable from the open position to the closed position during or upon disengaging the filling member from the valve.
In some embodiment, the closure includes a shutter extending annularly about the shaft.
In accordance with another aspect, a connector comprises: first means for providing fluid to a second means for engaging the first means and for receiving fluid from the first means; the first means comprising third means for providing a conduit for the passage of fluid therethrough; fourth means formed at one end of the third means for engaging a valve; fifth means in fluid communication with the third means for passage of fluid from the third means therethrough; and sixth means for closing the third means; wherein at least one of the third means and the sixth means is movable between (i) a first position wherein the sixth means closes the fifth means; and (ii) a second position opening the fifth means; the second means comprising seventh means for engaging by the third means when the first means and the second means are in a connected position with each other; wherein a the seventh means is moveable between (i) a closed position, wherein the seventh means prevents the flow of fluid therethrough; and (ii) an open position, wherein the seventh means allows the flow of fluid therethrough; wherein at least one of the first means and the second means is moveable relative to each other between (i) a disconnected position wherein the at least one of the third means and the sixth means is in the first position and the seventh means is in the closed position; and (ii) a connected position wherein the fifth means has engaged and moved the seventh means from the closed position to the open position and the at least one of the third means and the sixth means is in the second position opening the fifth means.
In some embodiments, the first means is a first connector portion, the second means is a second connector portion, the third means is a filling member, the fourth means is a tip of the filling member, the fifth means is at least one port, the sixth means is a closure, and the seventh means is a valve.
In accordance with another aspect, a method comprises the following steps:
In some embodiments, the step of moving at least one of the closure and the shaft from the first position to the second position occurs with the step of moving the valve from the open position to the closed position.
In some embodiments, the method further comprises the step of sterilizing the first connector portion and the second connector portion.
In some embodiments, the step of moving at least one of the first connector portion and the second connector portion relative to each other from the disconnected position toward the connected position comprises both axial and rotational movement.
In some embodiments, the second connector portion further comprises a septum overlying the valve and the step of moving at least one of the first connector portion and the second connector portion relative to each other from the disconnected position toward the connected position further comprises moving the filling member through the septum and wiping the filling member with the septum. In some such embodiments, the wiping step comprises wiping the tip of the filling member with the septum. In some such embodiments, the wiping step comprises wiping the filling member with a septum defining a durometer within the range of about 5 Shore A to about 65 Shore A. In some such embodiments, the wiping step comprises wiping the piercing member with a septum defining a durometer within the range of about 25 Shore A to about 45 Shore A. In some such embodiments, the wiping step comprises wiping the filling member with a septum defining a thickness with the range of a thickness equivalent to about ½ the diameter of the filling member to a thickness equivalent to about double the diameter of the filling member. In some such embodiments, the wiping step achieves at least approximately a 3 log reduction in bio-burden of the filling member.
In accordance with another aspect, the method further comprises the following steps:
In some embodiments, contact between the at least one filling port and the septum if substantially prevented during the engaging and disengaging steps.
In some embodiments, the method further comprises performing the engaging, introducing and disengaging steps in a non-sterile environment or an environment defining a SAL of about log 3 or less; introducing a sterile fluid through the first and second connector portions; and maintaining the sterility of the filled fluid throughout the engaging, introducing and disengaging steps.
One advantage of the present invention is that it provides a closed system sterile transfer, such that product transferred within the system does not come in contact with the external environment or contaminants therefrom. Another advantage of the present inventions is that the filling device and the connector can aseptically fill and transfer fluid within a non-aseptic, non-sterile or relatively low SAL environment (e.g., about log 6 or lower). Other objects and advantages of the present invention, and/or of the currently preferred embodiments thereof, will become more readily apparent in view of the following detailed description and the accompanying drawings.
In
As shown in
The lower approximately dome or spherical-shaped portion 26 defines an integral spring 36. In some embodiments, the lower portion 26 is made of an elastomeric flexible material such as silicone and glass filled polybutylene terephthalate (PBT) or a silicone blend. However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the lower approximately dome or spherical-shaped portion may take any of numerous different shapes and/or configurations, or may be formed of any of numerous different materials, that are currently known, or that later become known, for performing the function of the integral spring as described herein. The integral spring 36 of the lower approximately dome or spherical-shaped portion 26 allows the flexible valve member 16 to move axially between a normally closed position, as shown in
The lower portion 26 includes a flow aperture 38 to allow the flow of substance therethrough when in the open position. However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the lower portion 26 may include any desired number of flow apertures, and the apertures may take any of numerous different configurations in order to, for example, achieve the desired flow of substance into and/or out of the chamber 20. The lower portion 26 further includes an annular flange 40 laterally projecting therefrom, proximally adjacent a lower end of the lower portion. The annular flange 40 defines an annular recess 42 in a bottom end thereof for sealingly receiving a corresponding first annular retaining member 44 of the shell 12, to sealingly mount the flexible valve member 16 within the shell 12. In the illustrated embodiment, the first annular retaining member 44 is in the form of an annular spike. However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the retaining member may take any of numerous different configurations that are currently known, or that later become known, for sealingly engaging the annular flange of the flexible valve member.
As illustrated in
In the illustrated embodiment, the second annular retaining member 52 of the shell 12 is axially recessed from an upper end of the shell 12. Consequently, when the valve body 14 is mounted therein, an upper end of the valve body 14 is correspondingly axially recessed from the upper end of the shell 12, thereby defining a portion of the sidewall of the shell 12, from the upper end of the valve body 14 to the upper end of the shell 12, as an axially-extending ledge 54. When the valve body 14 is mounted, the lower end of the cylindrical sidewall 46 of the valve body presses onto the top end of the laterally projecting annular flange 40 of the flexible valve member 16, thereby ensuring a sealing fit between the annular flange 40 and the first annular retaining member 44 of the shell 12.
As shown in
The upper end of the valve body 14 further defines an annular recess for fittingly receiving a septum 60 atop the axially-recessed cylindrical valve seat 56. In the illustrated embodiment, the septum 60 is over-molded into the annular recess and defines a top surface, flush with the top surface of the valve body, together defining a stop surface 62 of the valve body 14, as shown in
In
In the illustrated embodiment, the closure 78 is axially slideable, having an internal central cylindrical shutter 84 located at a distal end thereof, that slides axially over the shaft 72 and the flow ports 82. The shutter 84 projects from inside the distal end of the closure 78 to the tip 76 of the shaft 72 to seal off the ports 82 from the ambient atmosphere. In the illustrated embodiment of
In the illustrated embodiment of
As shown in the illustrated embodiment of
In the illustrated embodiment, the smooth tip 76 is defined by a smooth bulbous tip which mates with the axially extending socket 32. However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the filling device tip and the axially extending socket of the valve may define any of numerous other configurations that mate together, that are currently known, or that later become known.
As shown in
After the chamber 20 is filled as desired, the steps shown in
One advantage of the present invention is that the filling device, such as the cannula in the illustrated embodiment, defines a smooth tip. This is safer for use than a filling device with a sharp tip, which may cause injury. Further, the filling device does not pierce through the stopper of the valve but rather depresses the flexible valve member from a closed position to an open position. Thus, there is no chance for any septum material to dislodge and contaminate the substance within the attached container or device. In addition, there is no resulting aperture from penetration of the valve requiring resealing after the filling device is disengaged. Rather, the filling device naturally springs back into the closed and sealed position.
In
In the illustrated embodiment, the male connector 170 comprises a male shell 188, having a filling member 190, a closure 178, and a spring element 186. As shown in
As shown in
In the illustrated embodiment the cylindrical closure 178 is mounted within the cylindrical male shell 188, and includes a central cylindrical shutter 184, axially-extending from a rear wall 200 of the closure. The shutter 184 receives a portion of the filling member 190 including the ports 182 and extends both annularly and axially thereabout. The closure 178 is both rotatable and axially moveable with respect to the male shell 188. The closure 178 and/or the male shell 188 is axially movable between (i) a first position wherein the shutter 184 closes the ports 182, as shown typically in
The male connector 14 also includes ribs 202, projecting inwardly from the interior wall of the male shell 188 and abutting the rear wall 200 of the closure 178, to normally prevent the closure from moving from the first position toward the second position. The closure 178 includes corresponding slots 204 extending distally from the rear wall 200 thereof, for receiving said ribs. Only when the ribs 202 align with the slots 204, can the closure 178 axially move from the first position to the second position. The male shell 188 and the closure 178 must first be rotated with respect to one another, in order to align the ribs 202 with the slots 204, as explained further below.
As shown in
The closure 178 also includes axially-extending projections 208, projecting inwardly from the cylindrical side wall 206 of the closure, for engaging secondary receiving slots 230 of the female connector 110, as explained further below. In the illustrated embodiment, the axially-extending projections 208, extend the entire length of the closure sidewall 206, but in other embodiments may not.
In the illustrated embodiment, as shown in
The substantially dome-shaped portion 212 of the spring element 186 is formed of a resilient and/or elastomeric material defining an integral spring therein. The integral spring can be manually compressed and maintained in the compressed state. Otherwise, the integral spring naturally rebounds and biases the closure 178 in a direction from the second or open position to the first or closed position. At the junction of the cylindrical portion 210 and the dome-shaped portion 212, the spring element 186 includes an inwardly-extending annular seal 218, sealingly engaging and slideable relative to the first hollow shaft 172 and vice versa. In the illustrated embodiment, the slideable seal is an O-ring, integrally formed with the spring element 186. However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the slideable seal may take the form of any sealing member, currently known or that later becomes known, capable of sliding along and sealingly engaging the hollow shaft of the filling member and may not be integral with the spring element.
As shown in
As shown in
As shown in
As shown in
As shown in
As the lugs 194 move down the first axially-extending portion 232 of the primary slots 228, the tip 176 of the filling member 190 correspondingly passes through the septum passageway 164. As shown typically in
The male connector 170 is thereafter rotated to move the lugs 194 along the first substantially horizontal portion 234 of the primary slots 228, as shown in
Upon rotation to the end of the first substantially horizontal portion 234 of the primary slots 228, the ribs 202 of the male shell 188 and the corresponding slots 204 extending from the rear wall of the closure 178 align. Only then can the closure and/or the male shell be moved axially relative to one another to move the ports 182 into the second or open position. The male connector 170 is thus pressed into further axial engagement with the female connector 110, and the lugs 194 move down the second axially-extending portion 236, as shown in
Upon reaching the end of the second axially-extending portion 236 of the primary slots 228, the male connector 170 is rotated again to slide the lugs 194 along the second substantially horizontal portion 238 of the primary slots, as shown in
To disconnect the male and female connectors 170, 110, the connecting steps are generally reversed. First, the male connector 170 is rotated to slide the lugs 194 in the reverse direction along the second substantially horizontal portion 238 (if present) of the primary slots 228, thereby unlocking the ports 182 from the open position. Upon reaching the opposing end of the second substantially horizontal portion and subsequent movement along portion 236, the spring element 186 naturally rebounds to return the ports 182 from the open position into the normally closed position, wherein the ports are again sealingly covered by the shutter 184. The shutter 184 remains interposed between the ports 182 and the septum 160 and therefore substantially prevents contact between the ports and the septum. The closed position is thereafter maintained, e.g., by the bias of the spring element 186 throughout the remainder of the disconnection process. Also as the lugs 194 move along the portion 236, the spring 136 of the flexible valve member 116 likewise simultaneously naturally rebounds to return the flexible valve member 116 from the open position, back into the normally closed position, where the sealing surface 128 thereof reengages the valve seat 156, and reseals the interior of the second shaft 112 and any fluid therein from the ambient atmosphere. The lugs 194 are moved back up the second axially-extending portion 236 of the primary slots 228 with the natural rebound of the sprint elements 136 and 186. Thereafter, the male connector 170 is rotated to move the lugs 194 along the first substantially horizontal portion 234 of the primary slots 228, returning the male connector 170 to its original configuration. The male connector 170 is then pulled out of engagement from the female connector 110, thereby withdrawing the tip 176 of the filling member 190 from the septum 160 and withdrawing the lugs 194 and the axially-extending projections 208 from the first axially-extending portion of the primary slots 228 and the secondary slots 230 respectively. The covering portion 240 may then be reengaged with the female connector 110.
The shutter 184 remains closed over the ports 182 and prevents contact between the ports and the septum 160 during withdrawal therefrom. Thus, during and upon, and in some embodiments, before, withdrawal of the filling member 190 from the septum 160, the shutter 184 maintains the ports 182 in the closed position and cannot be opened, thereby preventing any contamination of the ports or interior of the filling member.
The process may then be repeated whereby the male and female connectors are re-connected to aseptically transfer fluid therethrough once again. In some embodiments, the tip 176 of the filling member 190 may be re-sterilized prior to repeating connection of the two connectors. Sterilization and re-sterilization of the male and female connectors and/or any component parts therein may be achieved in accordance with the teachings in any of the following patents and patent applications, each of which is hereby expressly incorporated by reference in its entirety as part of the present disclosure: U.S. patent application Ser. No. 08/424,932, filed Apr. 19, 1995, entitled “Process for Filling a Sealed Receptacle under Aseptic Conditions,” issued as U.S. Pat. No. 5,641,004; U.S. patent application Ser. No. 09/781,846, filed Feb. 12, 2001, entitled “Medicament Vial Having a Heat-Sealable Cap, and Apparatus and Method for Filling Vial,” issued as U.S. Pat. No. 6,604,561, which, in turn, claims benefit of U.S. Provisional Patent Application No. 60/182,139, filed Feb. 11, 2000, entitled “Heat-Sealable Cap for Medicament Vial;” US. patent application Ser. No. 10/655,455, filed Sep. 3, 2003, entitled “Sealed Containers and Methods of Making and Filling Same,” issued as U.S. Pat. No. 7,100,646, which, in turn, claims benefit of similarly titled U.S. Provisional Patent Application No 60/408,068, filed Sep. 3, 2002; U.S. patent application Ser. No. 10/766,172, filed Jan. 28, 2004, entitled “Medicament Vial Having a Heat-Sealable Cap, and Apparatus and Method for Filling the Vial,” issued as U.S. Pat. No. 7,032,631, which, in turn claims benefit of similarly titled U.S. Provisional Patent Application No. 60/443,526, filed Jan. 28, 2003 and similarly titled U.S. Provisional Patent Application No. 60/484,204, filed Jun. 30, 2003; and U.S. Provisional Patent Application No. 61/625,663, filed Apr. 17, 2012, entitled “Self Closing Connector.”
In some embodiments, the septum 160 comprises a lower, i.e., base, layer having a relatively high durometer and an upper layer having a relatively lower durometer. In some such embodiments, the upper layer is not bondable with the lower layer and is over-molded thereon. In some such embodiments, the septum 160 may wipe the tip 176 of the filling member 190 and the shutter 184, of contaminants thereon during engagement and passage through the septum 160 by the tip 176, to prevent the tip and/or shutter from introducing such contaminants into the sterile interior of the female connector 110. The effectiveness of such wiping during piercing of the septum is dependent upon several factors, such as, for example, the wall thickness and durometer of the septum. In some embodiments, the durometer of the septum 160, or the layers thereof, is within the range of about 5 Shore A to about 65 Shore A, such as, for example, within the range of about 20 Shore A to about 50 Shore A. In some such embodiments, the durometer of the septum 160 is within the range of about 25 Shore A to about 45 Shore A. In some such embodiments the septum thickness is within the range of about ½ the diameter of the filling member to about double the largest diameter of the filling member. The present inventor has determined that the wiping effect on a tip surface by a septum having a wall thickness and durometer within said aforementioned ranges may achieve at least approximately a 3 log reduction in bio-burden when the male and female connectors are connected while immersed in a broth, which is about the reduction achieved by known UV pulse (5 second) sterilization techniques, to thereby at least partially sterilize the tip surface. Therefore, one advantage of the present invention is that it allows substantially sterile transfer of fluids within a non-aseptic, non-sterile or relatively low sterility assurance level (“SAL”) environment (e.g., about 6 log bio-burden or lower).
It should be noted that any portion of the tip 176 of the filling member 190 that is not wiped by the septum 160 is never exposed in the interior of the second shaft 112. The tip 176 is sealingly engaged by the socket 132 prior to moving the flexible valve member 116 from the sealingly closed position to the open position, and remains in sealing engagement with the socket 132 throughout the entire time the flexible valve member 116 is in the open position, until the flexible valve member rebounds back into the sealingly closed position. Any portion of the tip 176 that is not wiped by the septum is sealingly covered by the socket 132 and never exposed to the interior of the second shaft 112. The tip 176 sealingly engages the socket 132, due to, in part, the corresponding shape of the socket 132 with respect to the shape of the tip 176 along with the downward directed force applied to the filling member 190 to engage the socket 132 in conjunction with the opposing upward directed spring force of the spring 136 of the flexible valve member.
In
As shown in
For example, the septum 319a may be penetrable for sterile filling the variable-volume storage chamber 320 and resealable, such as by the application of laser, other radiation, or thermal energy, to hermetically seal the filled substance within the storage chamber 320 in accordance with the teachings of any of the following patents and patent applications, each of which is hereby expressly incorporated by reference in its entirety as part of the present disclosure: U.S. patent application Ser. No. 12/254,789, filed Oct. 20, 2008, entitled “Container Having a Closure and Removable Resealable Stopper for Sealing a Substance Therein and Related Method,” which, in turn, claims the benefit of U.S. Patent Application No. 60/981,107, filed Oct. 18, 2007, entitled “Container Having a Closure and Removable Resealable Stopper for Sealing a Substance Therein;” U.S. patent application Ser. No. 12/245,678, filed Oct. 3, 2008, entitled “Apparatus For Formulating and Aseptically Filling Liquid Products,” and U.S. patent application Ser. No. 12/245,681, filed Oct. 3, 2008, entitled “Method For Formulating and Aseptically Filling Liquid Products,” which, in turn, claim the benefit of U.S. Patent Application No. 60/997,675, filed Oct. 4, 2007, entitled “Apparatus and Method for Formulating and Aseptically Filling Liquid Products;” U.S. patent application Ser. No. 12/875,440, filed Sep. 3, 2010, entitled “Device with Needle Penetrable and Laser Resealable Portion and Related Method,” now U.S. Pat. No. 7,980,276, which is a divisional of U.S. patent application Ser. No. 12/371,386, filed Feb. 13, 2009, entitled “Device with Needle Penetrable and Laser Resealable Portion,” now U.S. Pat. No. 7,810,529, which is a continuation of U.S. patent application Ser. No. 11/949,087, filed Dec. 3, 2007, entitled “Device with Needle Penetrable and Laser Resealable Portion and Related Method,” now U.S. Pat. No. 7,490,639, which is a continuation of similarly titled U.S. patent application Ser. No. 11/879,485, filed Jul. 16, 2007, now U.S. Pat. No. 7,445,033, which is a continuation of similarly titled U.S. patent application Ser. No. 11/408,704, filed Apr. 21, 2006, now U.S. Pat. No. 7,243,689, which is a continuation of U.S. patent application Ser. No. 10/766,172, filed Jan. 28, 2004, entitled “Medicament Vial Having a Heat-Sealable Cap, and Apparatus and Method for Filling the Vial,” now U.S. Pat. No. 7,032,631, which is a continuation-in-part of similarly titled U.S. patent application Ser. No. 10/694,364, filed Oct. 27, 2003, now U.S. Pat. No. 6,805,170 which is a continuation of similarly titled U.S. patent application Ser. No. 10/393,966, filed Mar. 21, 2003, now U.S. Pat. No. 6,684,916, which is a divisional of similarly titled U.S. patent application Ser. No. 09/781,846, filed Feb. 12, 2001, now U.S. Pat. No. 6,604,561, which, in turn, claims the benefit of similarly titled U.S. Provisional Patent Application No. 60/182,139, filed Feb. 11, 2000, and similarly titled U.S. Provisional Patent Application No. 60/443,526, filed Jan. 28, 2003, and similarly titled U.S. Provisional Patent Application No. 60/484,204, filed Jun. 30, 2003; U.S. patent application Ser. No. 13/193,662, filed Jul. 29, 2011, entitled “Sealed Contained and Method of Filling and Resealing Same,” which is a continuation of U.S. patent application Ser. No. 12/791,629, filed Jun. 1, 2010, entitled “Sealed Containers and Methods of Making and Filling Same,” now U.S. Pat. No. 7,992,597, which is a divisional of U.S. patent application Ser. No. 11/515,162, filed Sep. 1, 2006, entitled “Sealed Containers and Methods of Making and Filling Same,” now U.S. Pat. No. 7,726,352, which is a continuation of U.S. patent application Ser. No. 10/655,455, filed Sep. 3, 2003, entitled “Sealed Containers and Methods of Making and Filling Same,” now U.S. Pat. No. 7,100,646, which is a continuation-in-part of U.S. patent application Ser. No. 10/393,966, filed Mar. 21, 2003, entitled “Medicament Vial Having A Heat-Sealable Cap, and Apparatus and Method For Filling The Vial,” now U.S. Pat. No. 6,684,916, which is a divisional of similarly titled U.S. patent application Ser. No. 09/781,846, filed Feb. 12, 2001, now U.S. Pat. No. 6,604,561, which, in turn, claims the benefit of similarly titled U.S. Provisional Patent Application No. 60/182,139, filed on Feb. 11, 2000, and U.S. Provisional Patent Application No. 60/408,068, filed Sep. 3, 2002, entitled “Sealed Containers and Methods Of Making and Filling Same;” U.S. patent application Ser. No. 12/627,655, filed Nov. 30, 2009, entitled “Adjustable Needle Filling and Laser Sealing Apparatus and Method,” now U.S. Pat. No. 8,096,333, which is a continuation of similarly titled U.S. patent application Ser. No. 10/983,178, filed Nov. 5, 2004, now U.S. Pat. No. 7,628,184, which, in turn, claims the benefit of U.S. Provisional Patent Application No. 60/518,267, filed Nov. 7, 2003, entitled “Needle Filling and Laser Sealing Station,” and similarly titled U.S. Provisional Patent Application No. 60/518,685, filed Nov. 10, 2003; U.S. patent application Ser. No. 11/901,467, filed Sep. 17, 2007 entitled “Apparatus and Method for Needle Filling and Laser Resealing,” which is a continuation of similarly titled U.S. patent application Ser. No. 11/510,961 filed Aug. 28, 2006, now U.S. Pat. No. 7,270,158, which is a continuation of similarly titled U.S. patent application Ser. No. 11/070,440, filed Mar. 2, 2005; now U.S. Pat. No. 7,096,896, which, in turn, claims the benefit of U.S. Provisional Patent Application No. 60/550,805, filed Mar. 5, 2004, entitled “Apparatus for Needle Filling and Laser Resealing;” U.S. patent application Ser. No. 12/768,885, filed Apr. 28, 2010, entitled “Apparatus for Molding and Assembling Containers with Stoppers and Filling Same,” now U.S. Pat. No. 7,975,453, which is a continuation of similarly titled U.S. patent application Ser. No. 11/074,513, filed Mar. 7, 2005, now U.S. Pat. No. 7,707,807, which claims the benefit of U.S. Provisional Patent Application No. 60/551,565, filed Mar. 8, 2004, entitled “Apparatus and Method For Molding and Assembling Containers With Stoppers and Filling Same;” U.S. patent application Ser. No. 13/396,053, filed Feb. 14, 2012, entitled “Method for Molding and Assembling Containers with Stopper and Filling Same,” which is a continuation of similarly titled U.S. patent application Ser. No. 12/715,821, filed Mar. 2, 2010, now U.S. Pat. No. 8,112,972, which is a continuation of similarly titled U.S. patent application Ser. No. 11/074,454, filed Mar. 7, 2005, now U.S. Pat. No. 7,669,390; U.S. patent application Ser. No. 11/339,966, filed Jan. 25, 2006, entitled “Container Closure With Overlying Needle Penetrable and Thermally Resealable Portion and Underlying Portion Compatible With Fat Containing Liquid Product, and Related Method,” now U.S. Pat. No. 7,954,521, which, in turn, claims the benefit of U.S. Provisional Patent Application No. 60/647,049, filed Jan. 25, 2005, entitled “Container with Needle Penetrable and Thermally Resealable Stopper, Snap-Ring, and Cap for Securing Stopper;” U.S. patent application Ser. No. 12/861,354, filed Aug. 23, 2010, entitled “Ready To Drink Container With Nipple and Needle Penetrable and Laser Resealable Portion, and Related Method;” which is a divisional of similarly titled U.S. patent application Ser. No. 11/786,206, filed Apr. 10, 2007, now U.S. Pat. No. 7,780,023, which, into turn, claims the benefit of similarly titled U.S. Provisional Patent Application No. 60/790,684, filed Apr. 10, 2006; U.S. patent application Ser. No. 11/295,251, filed Dec. 5, 2005, entitled “One-Way Valve, Apparatus and Method of Using the Valve,” now U.S. Pat. No. 7,322,491, which, in turn, claims the benefit of similarly titled U.S. Provisional Patent Application No. 60/644,130, filed Jan. 14, 2005, and similarly titled U.S. Provisional Patent Application No. 60/633,332, filed Dec. 4, 2004; U.S. patent application Ser. No. 12/789,565, filed May 28, 2010, entitled “Resealable Containers and Methods of Making, Filling and Resealing the Same,” which is a continuation of U.S. patent application Ser. No. 11/933,272, filed Oct. 31, 2007, entitled “Resealable Containers and Assemblies for Filling and Resealing Same,” now Pat. No. 7,726,357, which is a continuation of U.S. patent application Ser. No. 11/515,162, filed Sep. 1, 2006, entitled “Sealed Containers and Methods of Making and Filling Same,” now U.S. Pat. No. 7,726,352; U.S. patent application Ser. No. 13/045,655, filed Mar. 11, 2011, entitled “Sterile Filling Machine Having Filling Station and E-Beam Chamber,” which is a continuation of U.S. patent application Ser. No. 12/496,985, filed Jul. 2, 2009, entitled “Sterile Filling Machine Having Needle Filling Station and Conveyor,” now U.S. Pat. No. 7,905,257, which is a continuation of U.S. patent application Ser. No. 11/527,775, filed Sep. 25, 2006, entitled “Sterile Filling Machine Having Needle Filling Station within E-Beam Chamber,” now U.S. Pat. No. 7,556,066, which is a continuation of similarly titled U.S. patent aplication Ser. No. 11/103,803, filed Apr. 11, 2005, now U.S. Pat. No. 7,111,649, which is a continuation of similarly titled U.S. patent application Ser. No. 10/600,525, filed Jun. 19, 2003, now U.S. Pat. No. 6,929,040, which, in turn, claims the benefit of similarly-titled U.S. Provisional Patent Application No. 60/390,212, filed Jun. 19, 2002; U.S. patent application Ser. No. 13/326,177, filed Dec. 14, 2011, entitled “Device with Penetrable and Resealable Portion and Related Method,” which is a continuation of similarly titled U.S. patent application Ser. No. 13/170,613, filed Jun. 28, 2011, now U.S. Pat. No. 8,347,923, which is a continuation of U.S. patent application Ser. No. 12/401,567, filed Mar. 10, 2009, entitled “Device with Needle Penetrable and Laser Resealable Portion and Related Method,” now U.S. Pat. No. 7,967,034, which is a continuation of similarly titled U.S. patent application Ser. No. 11/933,300, filed Oct. 31, 2007, now U.S. Pat. No. 7,500,498; U.S. patent application Ser. No. 13/329,483, filed Apr. 30, 2011, entitled “Ready to Feed Container,” which is a continuation of International Application No. PCT/US2011/034703, filed Apr. 30, 2011, entitled “Ready to Feed Container and Method,” which, in turn, claims the benefit of U.S. Provisional Patent Application No. 61/330,263 filed Apr. 30, 2010; and U.S. Provisional Patent Application No. 61/476,523, filed Apr. 18, 2011, entitled “Filling Needle and Method.”
Alternatively, the septum 319a may be penetrable for sterile filling the variable-volume storage chamber 320 and resealable with a liquid sealant, such as a silicone sealant, to hermetically seal the filled substance within the storage chamber 320, in accordance with the teachings of any of the following patent applications, each of which is hereby expressly incorporated by reference in its entirety as part of the present disclosure: U.S. patent application Ser. No. 12/577,126, filed Oct. 9, 2009, entitled “Device with Co-Extruded Body and Flexible Inner Bladder and Related Apparatus and Method,” which claims the benefit of similarly titled U.S. Provisional Patent Application No. 61/104,613, filed Oct. 10, 2008; U.S. patent application Ser. No. 12/901,420, filed Oct. 8, 2010, entitled “Device with Co-Molded One-Way Valve and Variable Volume Storage Chamber and Related Method,” which claims the benefit of similarly titled U.S. Provisional Patent Application No. 61/250,363, filed Oct. 9, 2009; and U.S. Provisional Patent Application No. 61/476,523, filed Apr. 18, 2011, entitled “Filling Needle and Method.”
In the illustrated embodiment, the second port 310 is defined by a substantially cylindrical first shell 326 attached at a base end thereof to the pouch 318, and a second shell 327 secured at a base end thereof to the upper end of the first shell 326. The first shell 326 comprises a first hollow shaft 312a in fluid communication with the pouch 318 and a second, approximately central, hollow shaft 312b within the first hollow shaft. The upper end of the first shaft 312a (in the orientation in
The second shell includes a substantially cylindrical base portion 327a (secured to the first shell 326), a substantially cylindrical mid-portion 327b of different diameter, and an outer connector portion 327c of different diameter. In the illustrated embodiment, the connector portion 327c includes a male LUER connector. However, the connector portion 327c can take any suitable form of a connector, as should be appreciated by those of ordinary skill in the art. The outer portion 327c has a smaller diameter than the mid-portion 327b and therefore a first annular lip/shoulder 327d is defined at the interface therebetween. The mid-portion 310b has a smaller diameter than the base portion 310a, and therefore a second annular lip/shoulder 327e is formed at the interface therebetween. The diameter of the base portion 327a is substantially equal to the diameter of the first shell 326. The diameter of the mid-portion 327b is substantially equal to the diameter of the first shaft 312a. The first shell 326 and second shell 327 can be sealingly joined.
A septum or seat 360 is fittingly mounted into the outer portion 327c. In the illustrated embodiment, the septum 360 is over-molded or otherwise co-molded to the outer portion 327c, and an annular base thereof 360a is sealingly engaged with the corresponding annular lip 327d. The outer surface of the septum 360 is substantially flush with the outer surface of the outer portion 327c, and the septum 360 defines a septum passageway 364 therethrough. Similar to the embodiments above, the septum 360 is formed of an elastomeric material. However, as should be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the septum may be formed of any of numerous different materials that are currently known, or that later become known, for performing the function of the septum or seat as described herein.
The second port 310 further includes a plunger 325 therein. The plunger 325 comprises a substantially hollow barrel 329, having an open base end 329a, and an upper surface 329b. The open base end 329a is slidably received within the first shaft 312a, and thus the inside of the barrel 329 is in fluid communication with the first shaft 312a, and, in turn, with the storage chamber 320. An approximately central elongated tip 316 extends from the upper surface 329a of the barrel 329. An approximately central member 317 extends from the upper surface 329b into barrel 329, and in sliding engagement with the second shaft 312b. The upper surface 329b of the barrel 329 defines at least one fluid-flow aperture 338 therein.
As shown in
The plunger 325 is sealingly and slidably movable within the first shaft 312a of the first shell 326 and the second shell 327 between (i) a first position, as shown in
In the second position, the retracted tip 316 and the septum 360 define an open valve. As the tip 316 is spaced away from the passageway 364, and the upper surface 329b of the barrel 329 is spaced away from the base 360a of the septum 360, the aperture(s) 338 is placed in fluid communication with the opened passageway 364 for fluid flow therethrough.
The plunger 325 is biased in the direction from the second or open position to the first or closed position to normally close the aperture(s) 338. In the illustrated embodiment, the second port 310 includes a coil spring 336 that biases the plunger 325 in the direction from the second or open position to the first or closed position. The spring 336 encircles both the first shaft 312a and the barrel 329, and is mounted between the base end of the first shell 326 and a laterally-extending projection 329f of the barrel 329. The barrel 329 and second shell 327 are dimensioned such that in the first position, the projection 329f abuts the internal surface of the lip 327e, and in the second position the projection 329f abuts a stop surface 312c of the first shaft 312a. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the plunger 325 may be biased in any of numerous different ways that are currently known or that later become known, using biasing members other than springs, and if a spring is used, any of numerous different springs or combinations of springs may be used, e.g., a dome-shaped spring.
As shown in
When the syringe 370 is fully connected to the connector 327c and thus the plunger 325 is in the second position (
After the desired volume of fluid is transferred between the device 300 and the delivery device 370, the delivery device is disconnected (e.g., unthreaded) from the connector 327c. As the shaft 371a is withdrawn from the septum passageway 364, the spring 336 biases the plunger 325 and the tip 316 back into sealing engagement with the septum 360, to, in turn, maintain the sterility of the interior of the device 300.
As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, numerous changes and modifications may be made to the above-described and other embodiments of the present invention without departing from its scope as defined in the appended claims. For example, the components of the valve and filling device and/or the male and female connectors may be made of any of numerous different rigid or flexible materials that are currently known or that later become known for performing the functions of the various components. The valve and filling device may also be used with any of numerous different devices or containers, such as vials, syringes or other dispensers, or alternatively as part of a line, such as in a hospital environment for example. Further, the filing device and/or sealed empty device to be filled may be sterilized prior to filling with a fluid sterilant as disclosed in U.S. Provisional Patent Application No. 61/499,626, filed Jun. 21, 2011, entitled “Nitric Oxide Injection Sterilization Device and Method,” which is hereby expressly incorporated by reference in its entirety as part of the present disclosure as if fully set forth herein. Accordingly, this detailed description of embodiments is to be taken in an illustrative, as opposed to a limiting sense.
This patent application claims benefit under 35 U.S.C. § 119 to similarly-titled U.S. Provisional Patent Application No. 61/641,248, filed May 1, 2012, and 61/794,255, filed Mar. 15, 2013, both of which are hereby incorporated by reference in their entirety as part of the present disclosure.
| Number | Name | Date | Kind |
|---|---|---|---|
| 2304390 | Wolfram | Dec 1942 | A |
| 2819914 | Eitner | Jan 1958 | A |
| 3367366 | Klatte et al. | Feb 1968 | A |
| 3692029 | Adair | Sep 1972 | A |
| 3750667 | Pshenichny et al. | Aug 1973 | A |
| 3777771 | De Visscher | Dec 1973 | A |
| 3848645 | Franz | Nov 1974 | A |
| 4052989 | Kline | Oct 1977 | A |
| 4413985 | Wellner et al. | Nov 1983 | A |
| 4421146 | Bond et al. | Dec 1983 | A |
| 4610469 | Wolff-Mooij | Sep 1986 | A |
| 4700744 | Rutter et al. | Oct 1987 | A |
| 4752292 | Lopez et al. | Jun 1988 | A |
| 4756211 | Fellows | Jul 1988 | A |
| 4778447 | Velde | Oct 1988 | A |
| 4778453 | Lopez | Oct 1988 | A |
| 4790832 | Lopez | Dec 1988 | A |
| 4804015 | Albinsson | Feb 1989 | A |
| 4816024 | Sitar et al. | Mar 1989 | A |
| 4846805 | Sitar | Jul 1989 | A |
| 4894055 | Sudnak | Jan 1990 | A |
| 4917149 | Grantham | Apr 1990 | A |
| 4931048 | Lopez | Jun 1990 | A |
| 4938390 | Markva | Jul 1990 | A |
| 4969870 | Kramer et al. | Nov 1990 | A |
| 5049136 | Johnson | Sep 1991 | A |
| 5104382 | Brinkerhoff et al. | Apr 1992 | A |
| 5122123 | Vaillancourt | Jun 1992 | A |
| 5176643 | Kramer et al. | Jan 1993 | A |
| 5199947 | Lopez et al. | Apr 1993 | A |
| 5211197 | Marrison et al. | May 1993 | A |
| 5221197 | Marrison et al. | May 1993 | A |
| 5261891 | Brinkerhoff et al. | Nov 1993 | A |
| 5271744 | Kramer et al. | Dec 1993 | A |
| 5279583 | Shober, Jr. et al. | Jan 1994 | A |
| 5281206 | Lopez | Jan 1994 | A |
| 5312364 | Jacobs | May 1994 | A |
| 5344414 | Lopez et al. | Sep 1994 | A |
| 5380306 | Brinon | Jan 1995 | A |
| 5387197 | Smith et al. | Feb 1995 | A |
| 5429256 | Kestenbaum | Jul 1995 | A |
| 5451210 | Kramer et al. | Sep 1995 | A |
| 5478328 | Silverman et al. | Dec 1995 | A |
| 5482083 | Jenski | Jan 1996 | A |
| 5492147 | Challender et al. | Feb 1996 | A |
| 5520666 | Choudhury et al. | May 1996 | A |
| 5531692 | Rogers | Jul 1996 | A |
| 5549577 | Siegel et al. | Aug 1996 | A |
| 5575804 | Yoon | Nov 1996 | A |
| 5584848 | Yoon | Dec 1996 | A |
| 5607439 | Yoon | Mar 1997 | A |
| 5645556 | Yoon | Jul 1997 | A |
| 5669891 | Vaillancourt | Sep 1997 | A |
| 5685852 | Turkel et al. | Nov 1997 | A |
| 5694686 | Lopez et al. | Dec 1997 | A |
| 5713874 | Ferber | Feb 1998 | A |
| 5810768 | Lopez | Sep 1998 | A |
| 5810792 | Fangrow, Jr. et al. | Sep 1998 | A |
| 6032691 | Powell et al. | Mar 2000 | A |
| 6041805 | Gydesen et al. | Mar 2000 | A |
| 6071270 | Fowles et al. | Jun 2000 | A |
| 6079444 | Harris et al. | Jun 2000 | A |
| 6113068 | Ryan | Sep 2000 | A |
| 6113583 | Fowles et al. | Sep 2000 | A |
| 6135150 | Powell et al. | Oct 2000 | A |
| 6135167 | Kiholm | Oct 2000 | A |
| 6183442 | Athanasiou et al. | Feb 2001 | B1 |
| 6245048 | Fangrow, Jr. et al. | Jun 2001 | B1 |
| 6299131 | Ryan | Oct 2001 | B1 |
| 6394992 | Sjoholm | May 2002 | B1 |
| 6409304 | Taylor | Jun 2002 | B1 |
| 6428520 | Lopez et al. | Aug 2002 | B1 |
| 6478775 | Galt et al. | Nov 2002 | B1 |
| 6497686 | Adams et al. | Dec 2002 | B1 |
| 6554146 | DeGroff et al. | Apr 2003 | B1 |
| 6599273 | Lopez | Jul 2003 | B1 |
| 6604561 | Py | Aug 2003 | B2 |
| 6685674 | Douglas et al. | Feb 2004 | B2 |
| 6695817 | Fangrow, Jr. | Feb 2004 | B1 |
| 6726672 | Hanly et al. | Apr 2004 | B1 |
| 6866158 | Sommer et al. | Mar 2005 | B1 |
| 6837878 | Smutney et al. | Jun 2005 | B2 |
| 6989003 | Wing et al. | Jan 2006 | B2 |
| 6994315 | Ryan et al. | Feb 2006 | B2 |
| 7077176 | Py | Jul 2006 | B2 |
| 7099731 | Lopez | Aug 2006 | B2 |
| 7100646 | Py et al. | Sep 2006 | B2 |
| 7156826 | Ishii et al. | Jan 2007 | B2 |
| 7174914 | Ooishi et al. | Feb 2007 | B2 |
| 7309326 | Fangrow, Jr. | Dec 2007 | B2 |
| 7354427 | Fangrow | Apr 2008 | B2 |
| 7507227 | Fangrow | Mar 2009 | B2 |
| 7510547 | Fangrow | Mar 2009 | B2 |
| 7510548 | Fangrow | Mar 2009 | B2 |
| 7513895 | Fangrow | Apr 2009 | B2 |
| 7534239 | Fangrow | May 2009 | B1 |
| 7547300 | Fangrow | Jun 2009 | B2 |
| 7568509 | Py | Aug 2009 | B2 |
| 7569043 | Fangrow | Aug 2009 | B2 |
| 7645271 | Fangrow | Jan 2010 | B2 |
| 7648491 | Rogers | Jan 2010 | B2 |
| 7654995 | Warren et al. | Feb 2010 | B2 |
| 7658733 | Fangrow | Feb 2010 | B2 |
| 7670322 | Fangrow, Jr. | Mar 2010 | B2 |
| 7758566 | Simpson et al. | Jul 2010 | B2 |
| 7803139 | Fangrow, Jr. | Sep 2010 | B2 |
| 7824393 | Fangrow | Nov 2010 | B2 |
| 7883499 | Fangrow | Feb 2011 | B2 |
| 7892216 | Fangrow, Jr. | Feb 2011 | B2 |
| 7921875 | Moriiki et al. | Apr 2011 | B2 |
| 7931615 | Fangrow, Jr. | Apr 2011 | B2 |
| 8105314 | Fangrow, Jr. | Jan 2012 | B2 |
| 8196606 | Kitagawa | Jun 2012 | B2 |
| 8246578 | Matsumoto | Aug 2012 | B2 |
| 8348881 | Aubert et al. | Jan 2013 | B2 |
| 8409164 | Fangrow | Apr 2013 | B2 |
| 8454579 | Fangrow, Jr. | Jun 2013 | B2 |
| 8522832 | Lopez et al. | Sep 2013 | B2 |
| 8535279 | Schweikert et al. | Sep 2013 | B2 |
| 8552832 | Lopez et al. | Sep 2013 | B2 |
| 8647310 | Fangrow, Jr. et al. | Feb 2014 | B2 |
| 8696625 | Carrel et al. | Apr 2014 | B2 |
| 8758306 | Lopez et al. | Jun 2014 | B2 |
| 8759306 | Lopez et al. | Jun 2014 | B2 |
| 8808200 | Miller et al. | Aug 2014 | B2 |
| 8956330 | Fangrow, Jr. | Feb 2015 | B2 |
| 20020120212 | Ritchart et al. | Aug 2002 | A1 |
| 20020188260 | Gollobin | Dec 2002 | A1 |
| 20020189712 | Safabash | Dec 2002 | A1 |
| 20030032940 | Doyle | Feb 2003 | A1 |
| 20030070726 | Andreasson et al. | Apr 2003 | A1 |
| 20030106610 | Roos et al. | Jun 2003 | A1 |
| 20030216667 | Viola | Nov 2003 | A1 |
| 20040124389 | Phillips | Jul 2004 | A1 |
| 20040222224 | Plester | Nov 2004 | A1 |
| 20040256026 | Py | Dec 2004 | A1 |
| 20060142735 | Whitley | Jun 2006 | A1 |
| 20060178646 | Harris et al. | Aug 2006 | A1 |
| 20060287639 | Sharp | Dec 2006 | A1 |
| 20070106225 | Millerd | May 2007 | A1 |
| 20070225635 | Lynn | Sep 2007 | A1 |
| 20080103487 | Miyasaka | May 2008 | A1 |
| 20080197626 | Coambs et al. | Aug 2008 | A1 |
| 20090082725 | Witowski | Mar 2009 | A1 |
| 20090243281 | Seifert et al. | Oct 2009 | A1 |
| 20090292274 | Guala | Nov 2009 | A1 |
| 20100021230 | Olivier | Jan 2010 | A1 |
| 20100108681 | Jepson et al. | May 2010 | A1 |
| 20100121305 | Rogers | May 2010 | A1 |
| 20100140290 | Py | Jun 2010 | A1 |
| 20110060312 | Scheurer | Mar 2011 | A1 |
| 20110106046 | Hiranuma et al. | May 2011 | A1 |
| 20110186764 | Takami | Aug 2011 | A1 |
| 20110240158 | Py | Oct 2011 | A1 |
| 20120042971 | Py | Feb 2012 | A1 |
| 20120118416 | Johnson | May 2012 | A1 |
| 20120220978 | Lev et al. | Aug 2012 | A1 |
| 20120261027 | Py | Oct 2012 | A1 |
| 20130046246 | Cross et al. | Feb 2013 | A1 |
| Number | Date | Country |
|---|---|---|
| 1755181 | Apr 2016 | CN |
| 0174011 | Mar 1986 | EP |
| 2042798 | Apr 2009 | EP |
| 9311828 | Jun 1993 | WO |
| 9505863 | Mar 1995 | WO |
| 0198158 | Dec 2001 | WO |
| 2009035383 | Mar 2009 | WO |
| 2011146012 | Nov 2011 | WO |
| Entry |
|---|
| International Search Report and Written Opinion of the International Searching Authority for International Application No. PCT/US2013/039059, dated Aug. 22, 2013. |
| Number | Date | Country | |
|---|---|---|---|
| 20130292592 A1 | Nov 2013 | US |
| Number | Date | Country | |
|---|---|---|---|
| 61641248 | May 2012 | US | |
| 61794255 | Mar 2013 | US |
