The present invention relates (i) to devices and methods for decontaminating a surface, such as a cylindrical or frustoconical surface of a filling needle, by pure physical interaction with a wiping ring defined by a penetrable septum, (ii) to such a septum that is penetrable by a needle or other penetrating element; (iii) to devices and methods for decontaminating a filling needle, such as a closed filling needle, by interaction with a septum penetrable by the needle, where the resulting penetration hole in the septum is self-closing and re-sealable, such as hermetic resealing by thermal, chemical or mechanical resealing; and (iv) to devices and methods that enable sterile transfer of a product from within a closed needle or other closed penetration element into another closed sterile member or device, such as a sterile connector, connecting member or container.
A typical septum, such as stopper used to seal a vial or other device, is made of a material with some elongation property, such as an elastomer, or a rubber-like material, such as thermoplastic elastomer or silicone. The septum comprises an exterior surface defining a penetration zone that is penetrable by a needle, and an interior flange located on the underside of the septum that is received within, or otherwise attached to seal an opening in the vial or other type of device. The septum typically defines a flat exterior surface and a certain wall thickness in and around the penetration zone.
One of the drawbacks of such prior art septa is that when a needle penetrates through the penetration zone, the exterior surface that engages the needle cracks at the penetration site and can, in turn, invaginate, curl or roll inwardly at the opening about the needle, particularly under the axially-inward force exerted on the septum by the needle. As a result, any germs, bacteria or other contaminants on the exterior surface at the needle opening can be placed in communication with, and contaminate the interior of the vial or other device.
It is an object of the present invention to overcome one or more of the above-described drawbacks of the prior art.
In accordance with a first aspect, a septum is penetrable by a needle or other penetrating element and decontaminates by interaction between the septum and penetrating element. The septum comprises a peripheral portion extending about a periphery of the septum, an exterior surface located on the external side of the septum that may be exposed to a contaminated environment, and an internal surface that may be exposed to a sterile chamber or other sterile environment. A penetration area or portion of the septum extends between the exterior and interior surfaces, is spaced inwardly of the peripheral portion, and is penetrable by the needle or other penetrating element. A flex portion of the septum is located between the penetration area and the peripheral portion. A thicker portion of the septum extends between the flex portion and the penetration area, and preferably defines a thicker portion between the exterior and interior surfaces relative to the flex portion. The flex portion is flexible inwardly relative to the peripheral portion during penetration of the penetration area by a needle or other penetrating element, and the penetration portion physically interacts with and decontaminates the needle or other penetrating element.
In some embodiments, the thicker portion extends annularly about the penetration portion. In some such embodiments, the septum defines an axis of symmetry, the flex portion is located on one side of a plane that is substantially normal to the axis of symmetry, and at least a portion of the interior surface defining the thicker portion is located on an opposite side of the plane relative to the flex portion. In some such embodiments, the interior surface of the thicker portion is spaced below the plane, and the interior surface of the flex portion is spaced above the plane. In some embodiments, the thicker portion is defined by a curvilinear-shaped interior surface. In some such embodiments, the thicker portion is defined by a substantially dome-shaped interior surface. In some such embodiments, the dome-shaped interior surface defines a recess, such as a substantially concave-shaped recess, at the penetration area. In some embodiments, the thicker portion is defined by a substantially toroidal-shaped, semi-toroidal-shaped, or partial toroidal-shaped interior surface. In some embodiments, the thicker portion is substantially convex-shaped in cross section, and preferably defines an annularly extending, substantially convex lobe that depends downwardly and extends between the flex and penetration portions.
In some embodiments, the penetration area defines a reduced thickness between the exterior and interior surfaces as compared to the thicker portion. In some embodiments, the exterior surface is one or more of substantially dome-shaped and substantially convex-shaped. In some such embodiments, the penetration area is defined by a recess in the exterior surface. In some such embodiments, the recess is substantially conically shaped. In some such embodiments, the recess is substantially frustoconically shaped. In some embodiments, the recess defines a substantially planar base portion forming a penetrable exterior surface of the penetration area.
In some embodiments, the flex portion includes a groove in the exterior surface extending about the thicker portion between the thicker portion and the peripheral portion. In some such embodiments, the groove extends annularly about the thicker portion and extends radially between the peripheral portion and the thicker portion. In some such embodiments, the groove is substantially v-shaped or u-shaped in cross section.
In some embodiments, both the exterior surface and the interior surface at the thicker portion are approximately dome-shaped. In some such embodiments, the exterior surface is approximately convex-shaped, and the interior surface at the thicker portion is also approximately convex-shaped. In some such embodiments, the flex portion defines an annular recess extending between the peripheral portion and the thicker portion. In some such embodiments, the annular recess is approximately concave-shaped in cross section.
In some embodiments, the thicker portion is configured/adapted to one or more of (i) reduce strain on the interior surface of the penetration area as compared to the exterior surface of the penetration area during penetration by the needle or other penetrating element; (ii) apply an annular zone of relatively high radial pressure between an exterior surface of the penetration area and the needle or other penetrating element, as compared to the radial pressure between an interior surface of the penetration area and the needle or other penetrating element during penetration by the needle or other penetrating element; and (iii) space the exterior surface at the penetration portion from the interior surface during penetration by the needle or other penetrating element to thereby provide a zone or ring of safety between the exterior and interior surfaces where the needle or other penetrating element penetrates the penetration area.
In some embodiments, the peripheral portion is one or more of co-molded with, over-molded to, or fixedly secured to, a mounting surface of a device. The device may take the form of any of numerous different devices that are currently known or that later become known, including devices with storage chambers sealed with respect to the ambient atmosphere by one or more septa, such as vials, syringes, bottles, containers, tubes, and dispensers, and connectors, such as sterile connectors where the septum forms a part of a female connector that is penetrated by a male connector to form a sterile connection between the male and female connectors, and to transfer a product or fluid through the sterile connection
In some embodiments, the penetration portion is configured such that an aperture formed in the septum by the needle or other penetrating element closes or seals progressively in a direction from the interior surface of the septum toward the exterior surface of the septum as the needle or other penetrating element is withdrawn from the septum. In some embodiments, the septum is configured to prevent liquid or contaminants from passing or flowing from the exterior surface of the septum to the interior surface of the septum as the needle or other penetrating element is withdrawn from the septum. The septum may also be configured to move liquid film or contaminants from one or more of (i) a surface of the needle or other penetrating element or (ii) the penetration portion and toward the exterior surface of the septum during withdrawal of the needle or other penetrating element from the septum.
In accordance with another aspect, a septum is penetrable by a needle or other penetrating element and decontaminates by interaction between the septum and penetrating element. The septum comprises: (i) first means extending about a periphery of the septum for attaching the septum to a device; (ii) second means extending between exterior and interior surfaces of the septum that is spaced inwardly of the first means for penetration by the needle or other penetrating element and for physically interacting with and decontaminating the needle or other penetrating element; (iii) third means located between the first means and the second means for flexing inwardly relative to the first means during penetration of the second means by a needle or other penetrating element; and (iv) fourth means extending between the second means and the third means for one or more of (a) reducing strain on the interior surface of the second means as compared to the exterior surface of the second means during penetration by the needle or other penetrating element, (b) applying an annular zone of relatively high pressure between an exterior portion of the second means and the needle or other penetrating element as compared to an interior portion of the second means, and (c) spacing the exterior surface at the second means from the interior surface thereof during penetration thereof by the needle or other penetrating element, to thereby provide a zone or ring of safety between the exterior and interior surfaces where the needle or other penetrating element penetrates the second means.
In some embodiments of the present invention, the first means is a peripheral portion of the septum, the second means a penetration portion or area of the septum, the third means is a flex portion of the septum, and the fourth means is an increased thickness or thicker portion of the septum.
In accordance with another aspect, a method, such as a method of decontaminating a needle or other penetrable element by physical interaction between the needle or other penetrating element during penetration of a septum, comprises the following steps:
In some embodiments, the method further comprises reducing the strain, or incurring a lower strain, on the interior surface of the penetration area as compared to the exterior surface of the penetration area, during penetration by the needle or other penetrating element. Such embodiments may further comprise preventing the exterior surface of the penetration area from invaginating, curling or rolling inwardly at or about the penetration hole about the needle as the needle or other penetrating element pierces through the interior surface of the penetration area. Such embodiments may further comprise preventing any germs, bacteria or other contaminants on the exterior surface at the penetration hole from being placed in communication with, and contaminating the interior of the septum, or the environment of the interior surface of the septum, such as a sterile chamber of a device.
Some embodiments further comprise spacing the exterior surface at the penetration area from the interior surface thereof during penetration by the needle or other penetrating element, and providing a zone or ring of safety between the exterior and interior surfaces at the interface of the needle or other penetrating element. The zone or ring of safety prevents any germs, bacteria or other contaminants on the exterior surface at the penetration hole from being placed in communication with, and contaminating the interior of the septum, or the environment of the interior surface of the septum, such as a sterile chamber of a device.
In some embodiments, the method further comprises withdrawing the needle or other penetrating element from the septum, and, during this withdrawing, applying a zone of relatively high, approximately radial pressure onto the needle or other penetrating element at or near the exterior surface of the penetration portion, and applying a zone of relatively lower, approximately radial pressure onto the needle or other penetrating element at or near the internal surface of the penetration portion. In some such embodiments, the method may further comprise progressively wiping the needle or other penetrating element and thereby preventing liquid or contaminants from passing or flowing from the exterior surface of the penetration portion or the exterior surface of the needle or other penetrating element to the interior surface of the penetration portion.
In some such embodiments, the step of wiping during the withdrawing step includes wiping the needle or other penetrating element in a direction from the interior surface of the septum toward the exterior surface of the septum. In some such embodiments, the method further comprises progressively closing or sealing an aperture formed in the septum by the needle or other penetrating element in a direction from the interior surface of the penetration portion toward the exterior surface of the penetration portion. In some such embodiments, the method may comprise moving liquid film or contaminants from one or more of (i) a surface of the needle or other penetrating element or (ii) the penetration portion and toward the exterior surface of the penetration portion during withdrawal of the needle or other penetrating element from the septum.
One advantage of embodiments of the present invention is that the thicker portion reduces the strain on the interior surface of the penetration area as compared to the exterior surface of the penetration area during penetration thereof by the needle or other penetrating element. As a result, when the needle or other penetrating element pierces through the interior surface of the penetration area, the exterior surface is generally prevented from invaginating, curling or rolling inwardly at the penetration hole about the needle. This in turn prevents or reduces any germs, bacteria or other contaminants on the exterior surface at the penetration hole from being placed in communication with, and contaminating the interior of the septum, or the environment of the interior surface of the septum.
Yet another advantage of some embodiments of the present invention is that the dome-, convex- or other curvilinear-shaped exterior surface of the septum, in cooperation with the increased thickness portion, applies an annular zone or ring of relatively high radial pressure between the exterior surface of the penetration area and the needle or other penetrating element, as compared to the radial pressure between the interior surface of the penetration area and the needle or other penetrating element during penetration by the needle or other penetrating element. The annular ring of relatively high, radially-directed pressure is applied to the tip of the needle or other penetrating element at the interface of the pierced external surface of the septum as the tip penetrates the septum. Thus, as the needle or other penetrating element continues to penetrate the septum, the annular ring of relatively high, radially-directed pressure consecutively or progressively wipes the entire surface of the penetrating element that contacts the septum as it penetrates through the septum. The annular ring of relatively high pressure actively wipes the surface(s) of the penetrating element, starting at the tip as it penetrates the septum, and then progressively moves along the surfaces of the penetrating element as they penetrate the septum, to thereby decontaminate the penetrating element through such physical interaction between the septum and penetrating element.
Yet another advantage various embodiments of the present invention is that the strain reduction of the interior sterile layer enabled by the thicker portion spaces the external contaminated surface at the penetration portion from the sterile interior surface during penetration by the needle or other penetrating element, and thereby provides a zone or ring of safety between the exterior and interior surfaces in the penetration portion. As the needle or other penetrating element penetrates the penetration area, it stretches the material of the penetration area, thereby reducing the density of germs by surface elongation. The thicker portion about the penetration area, by elastic radial deformation, maintains sufficient inward or radially-directed pressure to generally prevent the depressed external surface from invaginating into the sterile inner cavity, and increases the zone or ring of safety between the exterior and interior surfaces at the interface between the needle or other penetrating element and the septum. The deformation as a whole is engineered to provide a relatively high pressure interface between the septum and penetrating element, the dynamics of which applies a wiping wave along the surfaces of the penetrating element as it penetrates through the septum, to thereby decontaminate the surfaces through such physical interaction, such as by the stress and friction at the interface.
Other objects and advantages of the present invention, and/or of the disclosed embodiments, will become more readily apparent in view of the following detailed description of embodiment and accompanying drawings.
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
In
The thicker portion 24 extends annularly about the penetration portion 20. As shown in
As shown in
The flex portion 22 includes an annular recess or groove 38 in the interior surface 18 extending about the thicker portion 24 between the thicker portion and the peripheral portion 14. In the illustrated embodiment, the groove 38 extends annularly about the thicker portion 24 and extends radially between the peripheral portion 14 and the thicker portion 24. In the illustrated embodiment, the groove 38 is substantially v-shaped in cross-section. However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the groove or recess of the flex portion may take any of numerous different shapes or configurations that are currently known, or that later become known, such as a u-shape or a concave shape, so as to facilitate flexing of the septum and engagement of the needle or like penetrating element 12 by the thicker portion 24 during penetration of the penetration portion 20. As shown in
In
Turning to
In some embodiments, the following pressures are exerted on the septum or needle in each of the regions or zones:
The dome-, convex- or other curvilinear-shaped exterior surface 16 of the septum 10, in cooperation with the thicker portion 24, applies an at least substantially annular zone 54 that can be seen in the Figures of relatively high radial pressure (e.g, horizontal or red) located at the interface of the needle tip 36 and the exterior surface 16 of the penetration portion contiguous and/or adjacent to the point where the needle tip penetrates the exterior surface 16. The horizontal or red zone 54 defines an annular zone of relatively high, approximately radial pressure between the exterior surface 16 of the penetration portion 20 and the needle 36, as compared to the approximately radial pressure in the forward slanted or purple zone 62 between the interior surface 18 of the penetration portion 20 and the needle 12, during penetration by the needle. As can be seen, the clear shaded/yellow and vertically shaded/green zones, 56 and 58, respectively, and to a lesser extent, the hatched shaded/light blue zone 60, also contribute to forming the annular zone of relatively high, approximately radial pressure.
As shown in
The annular ring of relatively high pressure at the interface of the interior surface of the penetration portion and the needle wipes the entire surface of the needle as it penetrates through the penetration portion. The annular ring of approximately radially directed, relatively high pressure causes the penetration portion to wipe the surface(s) of the needle, and thereby decontaminate the needle through such physical interaction between the septum and penetrating element. As also shown exemplarily in
As shown best in
The relatively high pressure interface between the septum 10 and needle 12 provides a relatively high pressure wiping wave along the surfaces of the needle as it penetrates through the penetration portion 20 of the septum 10 to thereby decontaminate the surfaces through physical interaction, such as by the stress and friction at the interface. This wiping wave is further illustrated by the progressive movement of the highest pressure zone 54 from lowest portion of the tip 36 in
Turning to
After the needle is inserted into the container and fluid is delivered therethrough, liquid film can remain on the surface of the needle. When the needle is withdrawn, this liquid film could become exposed to the atmosphere and pick up contaminants. These contaminants could, in turn, flow through the liquid film and into the container, e.g., by dripping, thus contaminating the substance in the container.
The configuration of the septum as shown in
As illustrated in
In some embodiments, following withdrawal of the needle from the septum, the resulting needle or penetration hole in the septa is self-resealed. This self-resealing occurs due to the elastic nature of the septum material, and the radial compression applied to such hole due to the dome or other curvilinear shapes of the exterior and/or interior surfaces of the septum. The self-resealing feature further protects the interior of the container from contamination.
The septa of the present invention may take the form or appearance of any septum that having the above-described features. For example, the septa may take the appearance of any of the septa disclosed in U.S. patent application Ser. No. 29/539,571, entitled “Septum,” filed Sep. 15, 2015, the contents of which are hereby incorporated by reference.
The septa of the present invention may be used with or in any of numerous different devices, filled in any of numerous different filling apparatus, and filled in accordance with any of numerous different filling methods, including the devices, apparatus and methods disclosed in the following co-pending patent applications, which are hereby incorporated by reference in their entireties as part of the present disclosure: U.S. patent application Ser. No. 14/214,890, filed Mar. 15, 2014, which claims benefit under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 61/798,210, filed Mar. 15, 2013; U.S. patent application Ser. No. 14/990,778, filed Jan. 7, 2016, which claims benefit under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62/100,725, filed Jan. 7, 2015; U.S. Provisional Patent Application No. 62/280,700, filed Jan. 19, 2016; U.S. Provisional Patent Application No. 62/295,139, filed Feb. 14, 2016; U.S. Provisional Patent Application No. 62/298,214, filed Feb. 22, 2016; U.S. Provisional Patent Application No. 62/323,561, filed Apr. 15, 2016. In addition, the septa of the present invention may be used in or as part of any of numerous different sterile connectors or other types of connectors, including any of the connectors disclosed in the following co-pending patent applications, which are hereby incorporated by reference in their entireties as part of the present disclosure: U.S. patent application Ser. No. 13/864,919, filed Apr. 17, 2014, which claims benefit under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 61/625,663, filed Apr. 17, 2012, No. 61/635,258, filed Apr. 18, 2012, and No. 61/784,764, filed Mar. 14,2013; and U.S. patent application Ser. No. 13/874,839, filed May 1, 2013 and U.S. patent application Ser. No. 14/535,566, filed Jul. 11, 2014, both of which claim benefit under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 61/641,248, filed May 1, 2012.
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, for example, in the appended claims. For example, the septa may be made of any of numerous different materials, such as any of numerous different natural or synthetic elastic materials, such as rubber, thermoplastic, silicone, or any of numerous different combinations or blends of one or more of the foregoing, that are currently known, or that later become known. In addition, the external shape and appearance of the septa may differ from the external shape and/or appearance illustrated herein. In addition to being self resealing, the septa may be configured for resealing with any of numerous different resealing mechanisms or processes that are currently known, or that later become known. For example, the septa may be configured for resealing through use of a liquid sealant, as disclosed in U.S. patent application Ser. No. 13/861,502, filed Apr. 12, 2013, now U.S. Pat. No. 8,966,866, issued Mar. 3, 2015, the contents of which are hereby incorporated by reference in its entirety as part of the present disclosure. The septa may also be configured for resealing by mechanical, chemical or thermal resealing, where the thermal resealing may be induced with any of numerous different energy sources or devices that are currently known or that later become known, such as by laser or ultrasonic mechanisms. It should further be understood that the features disclosed herein can be used in any combination or configuration, and are not limited to the particular combinations or configurations expressly specified or illustrated herein. Accordingly, this detailed description is to be taken in an illustrative as opposed to a limiting sense.
This patent application is a continuation of U.S. patent application Ser. No. 15/267,131, filed Sep. 15, 2016, which claims benefit under 35 U.S.C. § 119 to similarly-titled U.S. Provisional Patent Application No. 62/219,035, filed Sep. 15, 2015, which is hereby incorporated by reference in its entirety as part of the present disclosure.
Number | Date | Country | |
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62219035 | Sep 2015 | US |
Number | Date | Country | |
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Parent | 15267131 | Sep 2016 | US |
Child | 15944094 | US |