Patent Publication Number: US-2022219843-A1

Title: Needle with closure and method

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This patent application is a continuation of U.S. patent application Ser. No. 13/450,306, filed Apr. 18, 2012, claiming benefit under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application Ser. No. 61/476,523, entitled “Filling Needle and Method,” filed Apr. 18, 2011, which are hereby expressly incorporated by reference in its entirety as part of the present disclosure. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to needles, and more particularly, relates to filling needles and methods of filling with needles. 
     BACKGROUND INFORMATION 
     A typical prior art filling needle includes a hollow stainless steel shaft, a non-coring, conically-pointed tip fixedly secured to the distal end of the shaft, and diametrically opposed fluid ports proximal to the tip and in fluid communication between the interior of the shaft and the ambient atmosphere. One drawback encountered with prior art filling needles is that the interior of the needle, and any fluid contained therein, is exposed to the ambient atmosphere through the open fluid ports. Even though the needle ports or eyes are very small, the incidence of contamination in aseptic filling is such that there still can be a need to control the environment in prior art filling machines in order to protect the filling needles, and particularly the end opening(s) of the filling needles, regardless of type. If the ambient atmosphere is contaminated, the open ports can allow the interior of the needle and any fluid passing therethrough to become contaminated. On the other hand, if the needle is used to dispense a contaminated fluid, or a fluid that might be harmful if it is exposed to or comes into contact with a person, the open ports can allow such fluid to contaminate its ambient atmosphere or potentially harm a person that contacts the needle or is in the vicinity thereof. In prior art filling machines, including the needle filling and laser resealing machines described in the present inventor&#39;s U.S. Pat. No. 6,604,561, the regulatory agencies require control of the needle environment in order to protect against any exposure of the product itself to the environment and the resulting contamination of the product that might occur. Accordingly, the surfaces that may come into contact with the product, including the surfaces of the stopper and vial, are protected from the environment until the closed vial is pierced by the sterile needle. But, if for whatever reason, the latter were to be contaminated, a risk of contaminating the product inside the vial would exist. 
     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 and/or to reduce the controls over, or the need to control a filling needle environment. 
     SUMMARY OF THE INVENTION 
     In accordance with a first aspect, a needle comprises a hollow shaft; a tip formed at one end of the shaft; a port in fluid communication with the interior of the hollow shaft; and a closure. The closure and/or the shaft is movable between (i) a first position wherein the closure closes the port, and (ii) a second position opening the port. To prevent contamination of the needle from external sources, the closure may be configured to provide a substantially fluid-tight and/or airtight or hermetic seal between the port and ambient atmosphere in the closed position. 
     In some embodiments, the closure is biased in the direction from the second position to the first position to normally close the port. In some such embodiments, the needle includes a biasing member, e.g., a spring, biasing the closure in the direction from the second position to the first position. 
     In some embodiments, the closure is engageable with a penetrable septum to move the closure and/or the shaft from the first position wherein the closure closes the port, to the second position opening the port, upon penetrating the septum with the needle. In some such embodiments, at least one of the closure and the shaft is movable from the second position wherein the port is opened, to the first position wherein the port is closed, during or upon withdrawing the needle from the septum. 
     In some embodiments, the closure extends annularly about the shaft. In some embodiments, the closure includes a flange on one end thereof engageable with a biasing member or spring for biasing the closure in the direction from the second position to the first position. An opposite end of the closure is engageable with a stop surface of the needle to stop the closure in the first position. In some embodiments, a distal end of the closure is substantially flush with an adjacent portion of the needle tip. In some embodiments, the tip is defined by a non-coring, conically-pointed tip. 
     In accordance with another aspect, a needle comprises first means for providing a conduit for the passage of fluid therethrough; second means formed at one end of the first means for penetrating a septum; third means in fluid communication with the conduit for passage of fluid from the conduit therethrough; and fourth means for closing the third means. The fourth means and/or the first means is movable between (i) a first position wherein the fourth means closes the third means, and (ii) a second position opening the third means. In some embodiments, the first means is a needle shaft, the second means is a needle tip, the third means is a port, and the fourth means is a closure. 
     In accordance with another aspect, a method comprising the following steps: 
     (i) piercing a septum with a needle and placing the needle in fluid communication with a chamber; 
     (ii) during or after the piercing step, moving a closure and/or a filling port of the needle from a closed position closing the filling port to an open position opening the filling port; and 
     (iii) introducing fluid from the needle into the chamber after full perforation of the septum and/or after the needle port(s) or eye(s) have passed through the interior surface of the septum and are located within the chamber. 
     In accordance with another aspect, the method further comprises the following steps: 
     (iv) withdrawing the needle from the septum; and 
     (v) before and/or during the withdrawing step, moving the closure and/or the filling port of the needle from the open position to the closed position. 
     Some embodiments further comprise substantially sealing the filling port from ambient atmosphere in the closed position. Some embodiments further comprise substantially preventing any contact between the filling port and the septum during the penetrating and withdrawing steps. Some such embodiments further comprise interposing the closure between the filling port and septum to substantially prevent any contact between the filling port and septum. 
     Some embodiments further comprise the step of sealing the resulting penetration aperture in the septum. In these embodiments the self-closing properties of the septum material are engineered in a manner known to those of ordinary skill in the pertinent art based on the teachings herein to prevent any opening or passage between the needle and the pierced septum material, or any passage between the interior of the filling machine and the sterile chamber of the container or device to be filled after the septum is pierced. One objective and/or advantage of such embodiments is to demonstrate that the sterile container is always closed from its ambient environment even when mechanically opened by the filling needle so that after piercing and withdrawal of the needle, the visco-elastic or self-closing properties of the septum are such that any opening in the residual penetration aperture would be less than or equal to about 0.05 micrometer, such as less than or equal to about 0.02 micrometer, or even less than or equal to about 0.01 micrometer, or otherwise at a size that prevents fluid, including air, from penetrating through the resulting penetration aperture, prior to resealing thereof. In some such embodiments, the sealing step includes applying radiation or energy to the septum. In some embodiments, the sealing step includes at least one of thermal sealing, laser sealing and liquid sealant sealing. An exemplary liquid sealant is silicone. In some such embodiments, the liquid silicone is over-molded onto a compatible septum and/or cap material to ensure seal integrity and durability and enhance safety standards. 
     Some embodiments further comprise performing the penetrating, filling and withdrawing steps in a non-sterile or relatively low sterility assurance level (“SAL”) environment, such as about log 3 or lower, including about log 2 or about log 1; filling a sterile fluid through the needle and into the chamber; and maintaining the sterility of the filled fluid throughout the penetrating, filling and withdrawing steps. Some embodiments further comprise sealing a resulting penetration aperture in the septum and maintaining the sterility of the filled fluid during the sealing step. 
     One advantage of the present invention is that the closure closes the needle port(s) with respect to ambient atmosphere thereby preventing contamination of the needle port and interior of the needle and, in turn, preventing contamination of fluid flowing therethrough. Another advantage of certain embodiments is that they allow sterile filling within a non-aseptic, non-sterile or relatively low SAL environment (e.g., about log 3 or lower) while nevertheless sterile filling fluids into containers or devices and hermetically resealing them. Accordingly, the filling of a non-preserved or preservative-free formulation with a self-closing filling needle of the present invention without control of the filling needle environment, or with reduced needle environment controls, can be safer than filling a preserved formulation in an aseptically-controlled environment with prior art filling apparatus and methods. Yet another advantage of some embodiments is that the closure is interposed between the needle port and a septum to prevent contact between the needle port and septum, and thereby further prevent any contamination of the needle port and interior of the needle and of any fluid flowing therethrough. In some embodiments, the combination of the self-closing needle, such as the needle with “sliding shutter” closure, and a liquid silicone drop (“LSD”) or other resealable septum, creates a unique system and method allowing for the reduction or elimination of environmental controls required by prior art sterile filling systems and methods, thereby allowing for a simplification in equipment, a reduction in the time associated with setup and operation of the equipment, and/or a reduction in the cost of equipment and/or aseptic filling and processing. As a consequence, devices and methods of the invention facilitate the ability of manufacturers of any size, including small entity manufacturers, to safely fill preserved or preservative-free formulations into aseptic environments, and to do so at a lower cost, with improved efficiency and/or in less time, than required by prior art aseptic filling devices and methods. 
     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. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a sequential, cross-sectional view of a needle showing the separate components of the needle, and the assembly thereof; and 
         FIGS. 2A through 2E  are sequential cross-sectional views of the needle of  FIG. 1  showing the needle during penetration of and withdrawal from a resealable septum for filling a device or chamber of a device through such resealable septum. 
     
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION 
     In  FIGS. 1 and 2 , a needle is indicated generally by the reference numeral  10 . The needle  10  comprises a hollow shaft  12 , a tip  14  formed at one end of the shaft; two ports  16 ,  16  in fluid communication with the interior of the hollow shaft  12 , and a closure  18 . In the illustrated embodiments, the two ports  16  are diametrically opposed relative to each other; however, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the needle may define any number of ports that may define any of numerous different configurations and locations. The closure  18  and/or the shaft  12  is movable between (i) a first position wherein the closure closes the ports  16 , as shown typically in  FIG. 1 , and (ii) a second position opening the ports  16 , as shown typically in  FIG. 2C . In the illustrated embodiment, when in the closed position, the closure  18  forms a substantially fluid-tight seal between the ports  16  and ambient atmosphere. The closure  18  is biased in the direction from the second or open position to the first or closed position to normally close the ports  16 . In the illustrated embodiment, the needle  10  includes a coil spring  20  that biases the closure in the direction from the second or open position to the first or closed position. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the closure 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. In the illustrated embodiment, the closure  18  is an axially or vertically sliding “shutter” closure that slides axially over the needle shaft  12  between the normally closed and open positions. However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the closure may take any of numerous different configurations that are currently known, or that later become known, for performing the function of the closure as described herein. 
     The closure  18  extends both annularly and axially about the shaft  12  and is slidably mounted on the shaft. The closure  18  includes an annular flange  22  on one end thereof that is engageable with the spring  20  for biasing the closure in the direction from the second or open position to the first or closed position. An opposite end  24  of the closure  18  is engageable with an annular stop surface  26  of the needle tip to stop the closure in the first or closed position. The distal end  24  and substantially cylindrical body of the closure  18  are substantially flush with the perimeter of the stop surface  26  and adjacent portion of the needle tip  14 . The annular flange  22 , on the other hand, projects radially outwardly to provide a surface for seating and engaging the distal end of the spring  20 . In the illustrated embodiment, the needle tip  14  is defined by a non-coring, conically-pointed tip; however, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the needle tip may define any of numerous other needle tip configurations that are currently known, or that later become known, such as a trocar tip. In one configuration, the spring force of the spring  20  is sufficient to allow the needle to penetrate the septum while maintaining the closure  18  in the closed position during penetration of the closure through the septum and until the annular flange  22  of the closure engages an exterior surface of the septum (or other exterior or stop surface of the device) to cause relative movement of the closure and shaft against the bias of the spring from the normally closed position to the open position and, in turn, expose the sterile needle ports to the sterile device chamber. 
     An axially-elongated flange  28  includes bosses  30  that are received within corresponding apertures  32  formed in the needle shaft  12  to fixedly secure the flange to the shaft. A needle holder  34  is secured to the flange  28  and includes a barbed fitting  36  for attachment to a filling line (not shown). In the illustrated embodiment, the flange  28  is over-molded to the end of the shaft  12 , and the needle holder  34  is over-molded to the flange  28 . The coil spring  20  is mounted between the distal end of the axially-elongated flange  28  and the closure annular flange  22 . As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, any of numerous different types of fittings or connections that are currently known, or that later become known, equally may be employed for connecting the needle to a filling or other type of line or conduit. 
     As shown typically in  FIG. 2 , the needle  10  may be used to aseptically or sterile fill fluids through a penetrable septum  38  into a chamber  40  of a container or other device (not shown). As shown in  FIG. 2A , prior to penetrating the septum  38 , and when the needle tip  14  is exposed to the ambient atmosphere, the closure  18  is in the closed position sealing the ports  16  with respect to ambient atmosphere to thereby maintain the sterility of the ports and of the interior of the needle. As shown in  FIG. 2B , upon penetrating the septum  38 , the closure  18  is interposed between the ports  16  and the septum  38  to substantially prevent contact between the ports and the septum. Then, as shown in  FIG. 2C , when the ports  16  are located within the chamber  40 , the annular flange  22  of the closure engages the septum, and/or the frictional engagement between the cylindrical body of the closure  18  and the septum  38 , prevents further movement of the closure relative to the septum. Further penetration of the needle  10  into the septum  38  causes the shaft  12  and needle tip  14  to move relative to the closure  18  against the bias of the spring  20  to, in turn, move the ports  16  to the open position. In the open position of  FIG. 2C , the fluid within the needle is permitted to flow through the open ports  16  and into the chamber  40 . Since the sterile ports  16  are not exposed to the ambient atmosphere, the ports, interior of the needle, and fluid flowing therethrough, are not contaminated and/or are maintained sterile as the fluid is injected or otherwise dispensed into the chamber  40 . After the chamber  40  is filled as desired, and as shown typically in  FIG. 2D , the needle  10  is withdrawn from the septum  38 . As the needle is withdrawn, the spring  20  biases the closure  18  downwardly or in the direction of the septum  38 . Therefore, as the needle shaft  12  is withdrawn, it is moved axially relative to the closure  18  to, in turn, move the ports  16  into the closed position behind the closure. The sliding shutter or closure  18  may be configured to substantially prevent contact between the needle eyes or ports  16 , and the sliding shutter or closure is closed over the needle eyes or ports prior to their passage through the septum and/or withdrawal therefrom. When the end  24  of the closure  18  engages the stop surface  26  of the needle tip, the closure is fixed in the closed position, and is maintained in the closed position by the downward force or bias of the spring  20 . Thus, during and upon, and/or before, withdrawal of the needle  10  from the septum  38 , the closure  18  closes the ports  16  and prevents any contamination of the ports or interior of the needle. In some embodiments, the septum  38  is engineered to self-close and thereby ensure that the head loss left by the residual needle aperture  42  after the tip of the needle is withdrawn prevents any fluid ingress therethrough. 
     As shown typically in  FIG. 2E , although the septum may be self-closing as described above, the resulting needle or penetration aperture  42  in the septum may be resealed by a further process. Such processes include mechanically (such as by an overlying cover (not shown)), by applying radiation or energy to the septum, e.g., thermal resealing, by laser resealing, or by applying a liquid sealant thereto, which may be cured at room temperature or by applying radiation or energy to the sealant, such as a silicone or silicon-based sealant, e.g., UV (ultraviolet) or visible light curable composition, to form a fluid tight or hermetic seal and thereby maintain the sterility of the filled fluid in the chamber. Examples of resealable septums and processes for resealing them are described, for example, in the following patents and applications that are incorporated by reference in their entirety herein: 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 priority from U.S. Provisional Patent Application Ser. No. 60/182,139, filed Feb. 11, 2000, entitled “Heat-Sealable Cap for Medicament Vial;” U.S. 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 priority from similarly titled U.S. Provisional Patent Application Ser. 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 priority from similarly titled U.S. Provisional Patent Application Ser. No. 60/443,526, filed Jan. 28, 2003 and similarly titled U.S. Provisional Patent Application Ser. No. 60/484,204, filed Jun. 30, 2003; U.S. Provisional Patent Application entitled “Modular Filling Apparatus and Method,” filed Apr. 13, 2012; U.S. patent application Ser. No. 12/901,420, entitled “Device with Co-Molded Closure, One-Way Valve and Variable Volume Storage Chamber and Related Method,” filed Oct. 8, 2010, which, in turn, claims priority to similarly titled U.S. Provisional Patent Application Ser. No. 61/250,363, filed Oct. 9, 2009. The process then may be repeated whereby the same needle  10  may be used to aseptically or sterile fill plural or numerous chambers of devices. 
     When filling a sterile product, the self-closing septum  38  prevents the filled product from being contaminated by the device environment. In other applications, the self-closing septum prevents the product itself from contaminating its environment. For example, some products, such as cytotoxic products for treating cancer, or radioactive products, are hazardous and/or can be dangerous to operators, treatment professionals or other persons that might need to handle the filling machine or filled devices. Prior art equipment for handling such dangerous substances can be complex and costly. One advantage of the self-closing needle technology of the present invention is that it allows such dangerous or hazardous products to be filled and handled in a relatively safe and less costly manner than encountered in the prior art. 
     In another embodiment, the filling machine includes a first needle for piercing the septum (not shown), and a second self-closing needle for piercing the septum through the resulting penetration aperture formed by the first needle. In this embodiment, the first needle may be a solid needle without any lumen or closure, and may define a different diameter than the second needle, such as a smaller diameter. The first needle may be located in a first station and the second needle may be located in a second station, wherein the devices with septums are transported from the first station to the second station on a motorized conveyor. Each station may include an over pressure of sterile air or other gas. Alternatively, the first and second needles may be located in the same station on a common manifold or fixture to reduce the system footprint and/or to facilitate alignment of the second needle with the penetration aperture of the first needle. As described above, the septum is formed of a visco-elastic material that self-closes after withdrawal of each needle therefrom, and therefore prevents any contamination of the interior of the device between the first and second needle penetrations, and between the second needle penetration and resealing of the resulting penetration aperture. One advantage of this embodiment is that the penetration aperture formed by the first needle reduces that frictional force encountered by the second needle and closure during passage through the septum, and therefore reduces the spring force required to maintain the closure in the normally closed position during septum penetration. 
     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 needle, closure, spring of biasing member and holder may be made of any of numerous different metals or plastics that are currently known or that later become known. The term “needle” is used herein to mean any of numerous different types of devices that are used to penetrate and introduce matter into, or withdraw matter from, an object, such as a chamber or device, that are currently known, or that later become known. The term “septum” is used herein to mean any of numerous different types of needle penetrable septums, stoppers or other devices that are penetrable by a needle for filling a chamber therethrough. The needles may be used in sterile or non-sterile environments, to needle fill with or in accordance with any of numerous different filling devices or methods that are currently known, or that later become known. Accordingly, this detailed description of embodiments is to be taken in an illustrative, as opposed to a limiting sense.