1. Field of the Art
The present disclosure describes a closure for sealing a complementary opening. An exemplary embodiment includes an operating member having an operating surface that is contacted during insertion or removal; one or more sealing members which can impart a pressure-resistant seal; and a centering member that facilitates alignment of the closure during insertion. The closure can be operated manually or in an automated system. In another aspect, this disclosure describes methods of operating a closure, which can be manual or automated methods.
2. Description of Related Art
Medical testing is increasingly performed at central locations that process hundreds or even thousands of patient samples per day. These tests can be performed manually or with assistance of automated systems. Medical tests often involve processing biological samples to determine a patient characteristic. The biological sample is often provided in or as a fluid, or a fluid is generated as a test intermediate. Consequently, fluid containers and their closures are a central part of many medical tests.
Many conventional closures are not designed for high-throughput use, and perform poorly in such a demanding environment. Poor performance can lead to containment failure and compromised assay reliability. In high-throughput automated systems, closure problems can not only lead to loss of one particular sample, but also can jeopardize an entire sample run if the system becomes jammed, damaged, or contaminated due to one problem closure. Thus in high-throughput automated systems, there is a particular need for closures that are highly reliable and highly resistant to faults for example breakage, jamming, or containment failure.
For example, conventional push-type closures can be overly flexible, tending to become distorted when grasped with sufficient force to permit insertion, resulting in a poor seal that can cause containment failure. Other closures can be sufficiently rigid to prevent distortion, but (presumably for convenience of manufacturing) are made of a single material having uniform thickness throughout; consequently, the inserted portion of the closure in some instances can be overly rigid and unable to accommodate imperfect alignment, resulting in deformation or breakage of the closure, potentially resulting in containment failure. Many conventional push-type closures also lack centering features or aligning features, increasing the frequency of mis-insertion and risk of containment failure.
In view of the foregoing, there is a need in the art for improved closures that can be operated quickly, efficiently, consistently, and with sufficient reliability for use in a high-throughput setting. Further, while the following discussion emphasizes high-throughput uses in particular areas of the medical field, it will be readily apparent that the inventions described herein can in some instances be used separately or together and can have medical and testing applications beyond those described herein or even outside the medical field.
The present disclosure provides a number of inventions that can be used collectively, in various combinations, or alone. The following summary provides examples of such inventions, and does not limit the invention as claimed in any way.
In one exemplary aspect, the present disclosure provides a closure for sealing a complementary opening. The closure has an operating member, a lower member having a near end connected to the operating member and a far end spaced along an axial direction from the proximal end. One or more sealing members extend from the lower member. A first bore extends along the axial direction through the operating member and into the lower member. Second bores extend along the axial direction into the operating member. The second bores are located around the first bore with dividers between adjacent bores. The dividers are arranged to increase the compression stiffness of the operating member.
In another exemplary aspect, the present disclosure provides machines and methods for installing and removing a closure. In still other aspects, the disclosure provides various other embodiments of closures and features that can in some embodiments be used with closures.
The embodiments described below generally relate to closures that include one or more of a rigid operating member, a centering member, one or more sealing members, and one or more alignment features. These closures can give excellent performance in automated and manual operation. As noted above, many conventional closures are insufficiently reliable for use in a demanding environment, due to insufficient rigidity (leading to distortion during use), excessive rigidity (leading to inability to accommodate misalignment during insertion), and other shortcomings. To address these problems, the present closures include a rigid operating member and features that can prevent misalignment and/or features that can correct misalignment during insertion (examples of such features are described in further detail below).
“Operation” of a closure refers to insertion of a closure into a complementary opening or removal of a closure from a complementary opening, as well as the holding of a closure prior to or subsequent to insertion of a closure into a complementary opening or removal of a closure from a complementary opening.
“Complementary opening” refers to an opening into which a closure can be inserted to provide partial or complete obstruction of the opening. Where a closure includes one or more sealing members, a complementary opening can in some embodiments be an opening that includes one or more surfaces that will be contacted by the sealing members upon insertion, which can in some embodiments result in formation of a pressure-resistant seal.
“Pressure-resistant seal” refers to a seal formed upon insertion of a closure into a complementary opening that can prevent the passage of a fluid (liquid or gas) through the opening. A pressure-resistant seal can in some embodiments be further specified by reference to an amount of pressure that can be held against the seal, e.g., a 15 psi pressure-resistant seal refers to a seal that is pressure-resistant when the fluid is pressurized at 15 psi. Different pressure-resistance values can be specified with reference to particular fluids. In the context of a pressure-resistant seal, the pressure indicated typically will be gauge pressure, i.e., indicated relative to ambient pressure.
“Contact surface” refers to a surface that makes contact with a closure during operation. Exemplary contact surfaces include an automated gripper, a manually operated gripper, other manually operated tool for operating a closure, or a surface of an operator (e.g., a finger, hand, knuckle, thumb, tooth, etc. of a human or animal operator). One exemplary tool comprises a contact surface adapted to contact the underside or lateral side of the closure, a fulcrum across which to exert the force that will remove the closure, and optionally a lever for mechanical advantage, wherein said lever can in some embodiments comprise the structure that defines the opening.
When referring to a closure, relative spatial terminology for example “upper,” “middle,” “lower,” and the like are understood to refer to relative position when a closure is viewed in one particular orientation in which insertion of the closure would be performed in the direction from the upper to lower portion of the closure (e.g., as in the orientation depicted in
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In case of conflict, the present specification, including definitions, will control. Further, unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular. Exemplary methods and materials are described below, although methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention.
The following examples are provided to illustrate and help understand aspects and embodiments of the invention. These examples are not be construed as limiting the scope of the invention in any way.
Referring now to
The sealing members 110 may have any suitable shape and size. In one embodiment, the sealing members 110 can in some embodiments project outward from the lower member 112, in the form of annular rings, by between about 5 and about 15 times a substantially uniform thickness of the sealing member. This average distance may in some embodiments be between about 5 mm and about 15 mm. The thickness of the sealing member 110 can in other embodiments be between about 0.5 mm and about 2.0 mm. The thickness of each sealing members 110 in some embodiments is related to the minimum insertion force F by the formula:
F=[E*{(D−d)/D}]*[PI*D*T]*fs
wherein: E is the modulus of elasticity of the sealing member material; D is the diameter of the sealing member; d is the diameter of the opening; T is the substantially uniform thickness; and fs is the coefficient of static friction between the closure and the internal walls of the complementary opening. The values for these variables can in some embodiments be chosen such that the force F is approximately 10 N. In some embodiments, the minimum force required for insertion and removable of the closure can in some embodiments be between approximately 2 N and approximately 20 N or approximately 40 N.
Upon insertion, the two sealing members 110 provide a pressure-resistant seal capable of containing a fluid in the container. Each sealing member 110 will in some embodiments be able to individually provide a sufficient seal for many uses, such that the presence of two sealing members 110 provides redundancy and ensures containment even if one of the sealing members is damaged or defective. The two sealing members 110 also help ensure vertical orientation of the closure 100 in container 150 by contacting the container at two locations spaced along the closure axis.
Operating member 102 has sufficient rigidity to resist deformation and distortion when contacted with sufficient force for operation. For example, the operating member and the remainder of the closure 100 will in some embodiments be shaped and formed of a material such that the operating member has a modulus of elasticity between about 0.2 GPa and about 3.0 GPa as measured when the operating member is laterally compressed. By resisting distortion, the closures provide a consistent spatial relationship between operating member 102 and the remainder of the closure, and provides a more consistent shape for the closure throughout operation. This rigidity decreases or entirely eliminates undesired behaviors that might otherwise occur during use, including improper alignment, increased insertion or removal force, or failure to form a desired seal.
In addition to the foregoing exemplary embodiments, other embodiments and configurations of a closure having an operating member are also envisioned. For example, surfaces of the operating member will in different embodiments be vertical, horizontal, have other orientations, or include combinations of the foregoing or surfaces having multiple orientations. For example, a closure will in some embodiments include a shoulder or undercut that can be gripped or contacted from beneath when the closure is fully inserted to permit removal of the closure, an upper surface that can in some embodiments be contacted during insertion, lateral or angled surfaces that can be gripped during insertion and removal of the closure, and any combination thereof.
Upon insertion of a closure into an opening or during removal of a closure from an opening, the sealing members 110 can in some embodiments compress and/or deflect to form an interference fit, which can in some instances result in an approximately frustoconical or waved shape of the sealing members 110. Exemplary sealing members 110 can in different embodiments have a taper or draft angle, or can extend perpendicular to the closure axis, as shown in
In addition to the foregoing exemplary embodiments, other embodiments and configurations of a closure without a shoulder are also envisioned. For example, rather than insertion of the closure being arrested by contact between a shoulder and the container, a closure may not include any feature that arrests insertion. Alternatively, a closure can in some embodiments include an upper portion that widens along the direction of insertion, such that insertion is arrested by interference and friction.
In addition to the foregoing exemplary embodiments, other embodiments and configurations of a closure having a centering member 104 are also envisioned. For example, a centering member 104 can in some embodiments include a taper that is more or less sharp. A sharper taper tends to increase the centering force, which can facilitate faster insertion, but also can increase the overall length of the centering member, which can decrease the available volume inside a container, increase the likelihood that the closure will contact a contained liquid, and interfere with one-handed opening. A centering member can in some instances have a truncated or non-truncated end. A truncated end, when present, can have any desired taper or shape including rounded, flattened, concave, convex, etc. A truncated end decreases the width of the tapered surface and accordingly may in some embodiments decrease the amount of misalignment tolerance; however, where the truncated end is convex or rounded, the loss of mismatch tolerance can in some embodiments be somewhat mitigated. A rounded or convex end tends to allow liquids to accumulate on the tip and form drops of sufficient size to drip, which can in some embodiments allow liquids to drip back into their container before or during closure removal and prevent contamination; however, in other embodiments, the truncated end can be flattened or concave which tends to prevent dripping and can in some embodiments lead to decreased risk of contamination in some use conditions.
In addition to the foregoing exemplary embodiments, closures having other cross-sectional shapes are also envisioned. Portions of a closure can in some embodiments be independently be radially symmetrical, symmetrical about an N-fold axis of symmetry (where N is a positive integer greater than 1), or asymmetrical. For example, a centering feature and sealing member will generally match the shape of the opening, whereas an operating member need not match the shape of the opening. The closures can in some embodiments be adapted for use with an opening having any cross-sectional shape. Innumerable shapes are readily envisioned, with non-limiting examples including circles, ovals, other rounded shapes, squares, triangles, rectangles, other regular or irregular polygons (with optionally rounded corners), or any other closed convex or concave closed shape.
Referring now to
Referring now to
In addition to the foregoing exemplary embodiments, other embodiments and configurations of a closure having a sealing member are also envisioned. For example, one or more sealing members can in some embodiments contribute to centering, such that the centering member provides sufficient alignment that a sealing member can contact the opening, resulting in a contact force that tends to further guide the closure towards proper alignment. To further contribute to centering, sealing members can in some embodiments have staggered widths, with narrower centering members entering the opening before wider members, such that centering can proceed progressively as the closure is inserted. It is also envisioned that in some embodiments one or more of the sealing members can be variously shaped in order to help guide the closure in place, and in some embodiments may not actually form a seal against the container 150. Still further, one, some or all of the sealing members can alternatively form only a partial seal (i.e., a seal in which only a portion of the space between the closure and container is blocked), and a suitable seal can alternatively be formed by the collection of these partial seals, or by a supplemental seal, for example a gasket or o-ring located at the base of the operating member.
Referring now to
In addition to the foregoing exemplary embodiments, other embodiments and configurations of a closure having bored elements are also envisioned. Generally, bored elements are present when the structure of a portion of the closure comprises one or more walls that are formed around a protrusion or “core” on a part-forming mold. Coring can be used to create bores in the final structure, to retain much of the strength and rigidity of a non-bored structure while decreasing weight and material usage. Coring can in some instances reduce manufacturing costs by providing a closure of more uniform wall thickness. The addition of bores (by coring or other manufacturing methods) can in some embodiments also decrease the mass of the closure, potentially improving ease or speed of operation, and decrease costs of materials and shipping weight. As part of the closure can contact a contained liquid, the use of bored features can increase the tendency of liquids to adhere to the closure. When the closure is removed, the adhering liquids can in some instances drip, splatter, flow, or otherwise reach undesired locations outside the closure, potentially causing contamination of the work area containment, cross-contamination, or carry-over. To prevent these potential problems, in exemplary embodiments the portions of the closure that can come into contact with a contained liquid are not bored; or alternatively, the coring can in some embodiments comprise walls only in a vertical orientation (i.e., along the closure axis), such that when the container is oriented such that the closure is vertically oriented above the contained fluid, liquids tend to flow to the bottom of the closure and drop down to the container.
Referring now to
The exemplary alignment feature 514 is a bore that extends into the operating member 502, and also can in some embodiments extend into the lower member 512. An alignment pin 570 fits into alignment feature 514 and helps maintain the orientation and position of the closure 500 relative to a gripper (not shown in this figure) used for removal and insertion of the closure 500 into the container 550. The alignment pin 570 includes a taper 572 which has a different taper than the alignment feature 514. In alternative embodiments, the taper 572 of the alignment pin 570 can in some embodiments be the same as the taper of alignment feature 514. Tapered tip 574 of alignment pin 570 can in some embodiments contact bottom 516 of alignment feature 514 when fully inserted therein, and helps ensure proper alignment.
In addition to the foregoing exemplary embodiments, other embodiments and configurations of a closure made of other materials or of more than one material are also envisioned. For example, an inner structure of the closure can be made of a relatively hard material, then overmolded with a softer, more compliant material.
The distribution of mass in closure 500 is such that, when inserted into an opening, the center of mass of the closure is below the top of the opening. This distribution of mass can contribute to stability of the closure in the opening during use by counteracting the effects of small perturbations due to vibration and movement.
In addition to the foregoing exemplary embodiments, other embodiments and configurations of a closure having alignment features are also envisioned. For example, an alignment feature can in some embodiments include a structural feature (including projections, recesses, and combinations thereof) situated on an operating surface of the closure and providing increased control of alignment during operation. An alignment feature can also include one or more detectable features that are not necessarily contacted during operation, including optically, electromagnetically, or sonically detectable features, whose detection can provide feedback regarding position and/or orientation of the closure. An alignment feature can in some embodiments be used with manual cap operation or automated cap operation. For example, an alignment feature can in some embodiments comprise one or more raised or recessed surfaces located on an outer surface of the cap that are adapted to be complementary to a contact surface, for example an automated gripper, manually operated gripper or other manually operated tool for operating a closure, or a surface of an operator (for example a finger, hand, knuckle, thumb, toe, tooth, etc. of a human or animal operator). “Complementary” in this context means that some portion of the alignment feature is contacted by some portion of a contact surface during operation such that the contact tends to maintain a particular orientation of the closure. An alignment feature can in some embodiments serve a dual purpose of both facilitating alignment and facilitating operation. For example, an alignment feature can in some embodiments include a structural feature of a vertical surface which can provide positive contact, decrease likelihood of slipping, or otherwise improve reliability or stability of contact with the closure.
Referring now to
Referring now to
As shown in
Insertion of the closure 700 into a container is arrested by contact between shoulder 703 and the opening of the container. When the closure is fully inserted, shoulder 503 can in some embodiments protrude beyond the opening and can be contacted from below during removal. The vertical thickness of the operating member 702 is selected such that the center of mass of the closure 700 is lower than an opening when fully inserted therein, improving stability. The centering member 704 includes a tapered surface 706 and a truncated tip 708. If the closure 700 is misaligned during insertion, the tapered surface 706 or truncated tip 708 will contact the internal walls of the container and guide the closure toward proper alignment, provided that the degree of misalignment is not too great. The centering member 704 can in some embodiments be slightly narrower than the opening, but sufficiently wide to guide each sealing member 710 into contact with the opening, the resulting contact force tending to provide further improvement in alignment. The two sealing members 110 have staggered diameters, with the lower sealing member having a diameter about 0.4% less than the upper sealing member, such that centering can progressively improve as the closure is inserted and the sealing members 110 sequentially contact the closure. Upon insertion the two sealing members 710 provide a pressure-resistant seal capable of containing a fluid in the container. Each sealing member 710 is able to individually provide a sufficient seal for many uses, such that the presence of two sealing members 710 provides redundancy and ensures containment even if one of the sealing members is damaged or defective. The two sealing members 710 also help ensure vertical orientation of the closure 700 in a container.
The alignment feature 714 comprises a bore that extends into the operating member 702, and can in some embodiments extend into the lower member 712. In the exemplary embodiment, the alignment feature 714 extends all the way through the operating member 702, continues through the lower member 712, and terminates within the centering member 704. As shown, the alignment feature's shape can in some embodiments generally match the outer walls of the lower member 712 and centering member 704, so that the various features form a wall having a generally uniform thickness. An alignment pin (not shown) can fit into alignment feature 714 to help maintain the orientation and position of the closure 700 relative to a gripper (not shown in this figure) used for removal and insertion of the closure 700 into a container. The alignment pin can include a narrower taper than the alignment feature 514. The tip of an alignment pin can contact bottom 516 of alignment feature 514 when fully inserted therein to help ensure proper alignment. An alignment pin can in some embodiments also help support and add strength to the closure 700 during the installation and removal processes.
Also envisioned are methods of operating these or other closures. The closures can in some embodiments be operated manually, in an automated system, or with assistance of a tool or partial automation. For example, exemplary embodiments can in some embodiments be opened manually with one-hand. Where the portion of the closure inserted into the opening is sufficiently short, one-handed removal can in some embodiments be effected by grasping the container and pushing toward the center of the closure (e.g., with a thumb or against another surface). Alternatively, where the closure has a “shoulder” or other surface that is accessible from beneath when the closure is fully inserted, one-handed removal can in some embodiments be effected by simultaneously pushing upward and toward the center of the closure. A further method provides a combination of these approaches, wherein the operator first pushes toward the center of the closure, which provides partial opening and exposes a lower surface, and then pushing on this surface upward and toward the center of the closure. Yet a further method involves holding the container with three fingers while pinching the closure between the thumb and forefinger and pulling upward (and optionally, first loosening the closure with a lateral push). The closures can in some embodiments be twisted during insertion and/or removal, which can in some embodiments be performed during manual or automated operation. Such methods can in some embodiments be used when the closure has some freedom to rotate during operation (typically due to rotational symmetry). Use of a twisting movement can facilitate removal by decreasing force required. Without intent to be limited by theory, it is believed that a twisting motion can overcome static friction between the closure and container, thus insertion or removal would only require sufficient force in the direction of insertion or removal to overcome kinetic friction. Moreover, by decreasing friction, it is expected that sealing members (if present) could become less distorted during operation and accordingly provide less resistance to operation.
Referring now to
The closures, grippers, and methods described herein can in some embodiments be incorporated for use within a sample processing system. For example, an automated system can in some embodiments use these closures, grippers, or methods with input sample containers, output sample containers and/or intermediate sample containers between input and output processing. In one example, samples are provided in a container having a closure that is damaged or is incompatible with the automated system, in which case the sample can in some embodiments be transferred into a container that is then closed with an embodiment of the present closures. Example of such systems are described in U.S. application Ser. No. 12/588,304 (Attorney Docket No. 74708.000401), entitled “AUTOMATED ASSAY AND SYSTEM,” filed Oct. 9, 2009, and in U.S. application Ser. No. 12/588,306 (Attorney Docket No. 74708.001001), entitled “Open Platform Automated Sample Processing System,” filed Oct. 9, 2009, each of which is hereby incorporated by reference in its entirety.
It should be understood that the foregoing embodiments are exemplary only, and other embodiments will be apparent to those of ordinary skill in the art in light of the teachings provided herein. For example, while the foregoing embodiments describe closures and methods for use in medical testing, it will be readily apparent that these can in some embodiments be modified for use in other processes. As another example, a linkage element can in some embodiments be provided to couple a closure to the structure that defines the complementary opening (for example a test tube), such that the closure remains attached to the test tube when removed from the opening. A flexible and/or hinged element can in some embodiments be used as the linkage. Other variations will be apparent to those of ordinary skill in the art in view of the present disclosure and with practice of the invention.
This application claims the benefit of U.S. Provisional Application Ser. No. 61/272,603 filed Oct. 9, 2009, the disclosure of which is incorporated by reference herein in its entirety.
Number | Date | Country | |
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61272603 | Oct 2009 | US |