US20120261027A1

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Publication number: US20120261027A1
Application number: US13/450,306
Authority: US
Inventors: Daniel Py
Original assignee: Individual
Current assignee: Dr Py Institute LLC
Priority date: 2011-04-18
Filing date: 2012-04-18
Publication date: 2012-10-18
Also published as: WO2012145434A1; CN103608057B; EP2699295B1; US12097984B2; CN103608057A; US20220219843A1; US20250256870A1; EP2699295A4; RU2619747C2; BR112013027002A2; RU2013151061A; KR101839086B1; KR20140034794A; EP2699295A1

Abstract

A needle has a hollow shaft, a tip formed at one end of the shaft, one or more ports 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(s), and (ii) a second position opening the port(s).

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims the 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 is 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's U.S. Patent 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 aboutlog3 or lower, including aboutlog2 or aboutlog1; 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., aboutlog3 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 ofFIG. 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

InFIGS. 1 and 2, a needle is indicated generally by thereference numeral10. Theneedle10 comprises ahollow shaft12, atip14 formed at one end of the shaft; two

ports

16,16 in fluid communication with the interior of thehollow shaft12, and aclosure18. In the illustrated embodiments, the twoports16 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. Theclosure18 and/or theshaft12 is movable between (i) a first position wherein the closure closes theports16, as shown typically inFIG. 1, and (ii) a second position opening theports16, as shown typically inFIG. 2C. In the illustrated embodiment, when in the closed position, theclosure18 forms a substantially fluid-tight seal between theports16 and ambient atmosphere. Theclosure18 is biased in the direction from the second or open position to the first or closed position to normally close theports16. In the illustrated embodiment, theneedle10 includes acoil spring20 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, theclosure18 is an axially or vertically sliding “shutter” closure that slides axially over theneedle shaft12 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.

Theclosure18 extends both annularly and axially about theshaft12 and is slidably mounted on the shaft. Theclosure18 includes anannular flange22 on one end thereof that is engageable with thespring20 for biasing the closure in the direction from the second or open position to the first or closed position. Anopposite end24 of theclosure18 is engageable with anannular stop surface26 of the needle tip to stop the closure in the first or closed position. Thedistal end24 and substantially cylindrical body of theclosure18 are substantially flush with the perimeter of thestop surface26 and adjacent portion of theneedle tip14. Theannular flange22, on the other hand, projects radially outwardly to provide a surface for seating and engaging the distal end of thespring20. In the illustrated embodiment, theneedle tip14 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 thespring20 is sufficient to allow the needle to penetrate the septum while maintaining theclosure18 in the closed position during penetration of the closure through the septum and until theannular flange22 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-elongatedflange28 includesbosses30 that are received within correspondingapertures32 formed in theneedle shaft12 to fixedly secure the flange to the shaft. Aneedle holder34 is secured to theflange28 and includes abarbed fitting36 for attachment to a filling line (not shown). In the illustrated embodiment, theflange28 is over-molded to the end of theshaft12, and theneedle holder34 is over-molded to theflange28. Thecoil spring20 is mounted between the distal end of the axially-elongatedflange28 and the closureannular flange22. 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 inFIG. 2, theneedle10 may be used to aseptically or sterile fill fluids through apenetrable septum38 into achamber40 of a container or other device (not shown). As shown inFIG. 2A, prior to penetrating theseptum38, and when theneedle tip14 is exposed to the ambient atmosphere, theclosure18 is in the closed position sealing theports16 with respect to ambient atmosphere to thereby maintain the sterility of the ports and of the interior of the needle. As shown inFIG. 2B, upon penetrating theseptum38, theclosure18 is interposed between theports16 and theseptum38 to substantially prevent contact between the ports and the septum. Then, as shown inFIG. 2C, when theports16 are located within thechamber40, theannular flange22 of the closure engages the septum, and/or the frictional engagement between the cylindrical body of theclosure18 and theseptum38, prevents further movement of the closure relative to the septum. Further penetration of theneedle10 into theseptum38 causes theshaft12 andneedle tip14 to move relative to theclosure18 against the bias of thespring20 to, in turn, move theports16 to the open position. In the open position ofFIG. 2C, the fluid within the needle is permitted to flow through theopen ports16 and into thechamber40. Since thesterile ports16 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 thechamber40. After thechamber40 is filled as desired, and as shown typically inFIG. 2D, theneedle10 is withdrawn from theseptum38. As the needle is withdrawn, thespring20 biases theclosure18 downwardly or in the direction of theseptum38. Therefore, as theneedle shaft12 is withdrawn, it is moved axially relative to theclosure18 to, in turn, move theports16 into the closed position behind the closure. The sliding shutter orclosure18 may be configured to substantially prevent contact between the needle eyes orports16, 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 theend24 of theclosure18 engages thestop surface26 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 thespring20. Thus, during and upon, and/or before, withdrawal of theneedle10 from theseptum38, theclosure18 closes theports16 and prevents any contamination of the ports or interior of the needle. In some embodiments, theseptum38 is engineered to self-close and thereby ensure that the head loss left by theresidual needle aperture42 after the tip of the needle is withdrawn prevents any fluid ingress therethrough.

When filling a sterile product, the self-closingseptum38 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.