This application is related to U.S. application Ser. No. 13/874,017, entitled “APPARATUSES FOR SECURING COMPONENTS OF A DRUG DELIVERY SYSTEM DURING TRANSPORT AND METHODS OF USING SAME,” to the same applicants and filed on Apr. 30, 2013, the disclosure of which is incorporated herein by reference.
The present invention, in some embodiments thereof, relates to a high reliability telescoping assembly (TSA) and method of assembly for such and, more particularly, but not exclusively, to a unidirectional assembly method for a disengagement resistant TSA from molded parts.
U.S. Pat. No. 7,967,795 to the instant applicant (Cabiri) discloses A cartridge interface assembly including a driving plunger including an outer shaft, and a driver including an inner shaft, the inner shaft mating with an intermediate shaft, the intermediate shaft mating with the outer shaft, so that the shafts are movable telescopically with respect to one another, wherein rotation of the driver causes the driving plunger to advance in a direction away from the driver.
U.S. Patent Application Publication No. 2009/0093792 to Gross discloses an apparatus for administering a substance to a subject. A vial contains the substance and a stopper is disposed within the vial and is slidably coupled to the vial. A first threaded element is (a) rotatable with respect to the vial and (b) substantially immobile proximally with respect to the vial during rotation of the first threaded element. A second threaded element is threadedly coupled to the first threaded element. At least a distal end of the second threaded element is substantially non-rotatable with respect to the vial, and the distal end of the second threaded element defines a coupling portion that couples the second threaded element to the stopper. The first threaded element, by rotating, linearly advances the stopper and at least the distal end of the second threaded element toward a distal end of the vial.
International Patent Application Publication No. WO/2011/090956 to the instant applicant (Cabiri) disclosed a cartridge interface assembly characterized by a driving plunger including an outer shaft, and a driver including an inner shaft movable telescopically with respect to the outer shaft, wherein rotation of the driver causes the driving plunger to advance in a direction away from the driver, and wherein the cartridge interface assembly is inserted in a cartridge in which a plunger is slidingly disposed, and rotation of the driver causes the driving plunger to advance distally in the cartridge until abutting against the plunger.
U.S. Pat. No. 8,157,769 to the present instant applicant (Cabiri) discloses A cartridge insertion assembly including apparatus with a pathway formed therein, a cartridge insertable into the pathway, the cartridge including a cartridge coupling element connectable to an activation mechanism disposed in the apparatus operative to cause a substance contained in the cartridge to be metered out of the cartridge, and a door pivoted to the apparatus that includes a door coupling element arranged with respect to the cartridge such that when the door is in a fully closed position, the door coupling element couples the cartridge coupling element with a coupling element of the activation mechanism.
U.S. Pat. No. 7,225,694 to Said, discloses a telescopic actuator that has a lead screw and one or more concentric or tiered screws. Each screw has one or more tangential interference stop features such as stop cogs. As the lead screw is rotated, it translates out of the concentric screws. As the lead screw reaches its maximum extension, a tangential interference stop feature on the lead screw tangentially contacts a tangential interference stop feature on the concentric screw with which the lead screw is threadably engaged. Upon tangential contact, the associated concentric screw rotates in unison with the lead screw. When there are additional concentric screws, as each concentric screw reaches its maximum extension, the system of tangential contacting of tangential interference stop features causes the other concentric screws to extend out in sequential fashion.
Additional background art includes U.S. Pat. No. 8,220,349, U.S. Pat. No. 6,494,005, U.S. Pat. No. 6,435,048, and U.S. Pat. No. 6,382,039.
According to an aspect of some embodiments of the present invention there is provided a method of assembling a telescoping screw including: threading a leading end of an inner rod into a rear end of a mid rod; also threading a leading end of the mid rod into a rear end of an outer rod so that the leading end of the inner rod is accessible from an leading end of the outer rod, and fastening a first end cap onto the leading end of the inner rod.
According to some embodiments of the invention, the method may further include extending the telescoping screw by further threading the inner rod to extend the leading end of the inner rod out of the leading end of the outer rod.
According to some embodiments of the invention, the method may further include driving the extending by rotating the first end cap.
According to some embodiments of the invention, the method may further include also fastening a second end cap onto the rear end of the outer rod.
According to some embodiments of the invention, the method may further include driving extension of the telescoping screw by rotating the second end cap.
According to some embodiments of the invention, the method may further include preventing an unthreading of the telescoping screw by providing a rotational stopper to limit unthreading rotation of the first end cap with respect to the outer rod
According to some embodiments of the invention, the rotational stopper includes an interference element between first end cap and to the outer rod.
According to some embodiments of the invention, the method may further include preventing an unthreading of the telescoping screw by providing a rotational stopper to limit unthreading rotation of the second end cap with respect to the inner rod.
According to some embodiments of the invention, the method may further include pushing a load by extending the telescopic screw.
According to some embodiments of the invention, the load includes a plunger of a syringe and the method further includes discharging a drug from the syringe by the pushing of the plunger.
According to some embodiments of the invention, the method may further include extending the telescoping screw by further threading the mid rod to extend a leading end of the mid rod out of the leading end of the outer rod.
According to some embodiments of the invention, the method may further include providing a fastener on the leading end of the inner rod.
According to some embodiments of the invention, the inner rod is molded in one piece with the fastener.
According to some embodiments of the invention, the method may further include blocking over extension of the middle rod from the outer rod by a protrusion on the rear end of the middle rod.
According to some embodiments of the invention, the middle rod is molded in one piece with the protrusion.
According to some embodiments of the invention, the method may further include blocking over extension of the inner rod from the mid rod by a protrusion on a rear end of the inner rod.
According to some embodiments of the invention, the inner rod is molded in one piece with the protrusion.
According to some embodiments of the invention, the method may further include supporting the telescoping screw against an inside wall of a syringe via a shoulder.
According to an aspect of some embodiments of the present invention there is provided a telescoping assembly including: an outer rod including a rear fastener and a leading internal thread; a middle rod including an external thread fitting the internal thread of the outer rod, a rear protrusion wider than the internal thread of the outer rod and a leading internal thread; and an inner rod including an external thread fitting the internal thread of the middle rod and a rear protrusion wider than the internal thread of the middle rod.
According to some embodiments of the invention, each of the inner rod, mid rod and outer rod is molded in a single piece.
According to some embodiments of the invention, the telescoping assembly further includes a first end cap including a matching fastener for fastening to the rear fastener.
According to some embodiments of the invention, the telescoping assembly further includes a stopper for preventing dethreading of telescoping assembly, the stopper including an interference element on the first end cap for preventing rotation in a contracting direction of the inner rod with respect to the first end cap.
According to some embodiments of the invention, the inner rod further includes a leading fastener.
According to some embodiments of the invention, the telescoping assembly further includes a second end cap including a matching fastener for fastening to the leading fastener.
According to some embodiments of the invention, the telescoping assembly further includes a stopper for preventing dethreading of telescoping assembly, the stopper including an interference element on the second end cap for preventing rotation in a contracting direction of the outer rod with respect to the second end cap.
According to some embodiments of the invention, the telescoping assembly further includes a shoulder fitting into a bore of a syringe and rotatable with respect to the syringe the shoulder supporting the telescoping assembly.
According to some embodiments of the invention, the inner rod, the mid rod and the outer rod are all threaded in a first direction, and the telescoping assembly further includes an end cap with a thread in an opposite direction.
According to some embodiments of the invention, the respective pitch of threading of each of the inner rod, the mid rod and the outer rod is adjusted to produce the same magnitude of linear motion per rotation.
Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.
Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.
In the drawings:
The present invention, in some embodiments thereof, relates to a high reliability telescoping assembly (TSA) and method of assembly for such and, more particularly, but not exclusively, to a unidirectional assembly method for a disengagement resistant TSA from molded parts.
An aspect of some embodiments of the invention relates to providing a TSA that is assembled in a simple manner. Optionally, assembly may be unidirectional. Unidirectional assembly may include, for example, insertion of all or most extension rods from the same end of the TSA. Unidirectional assembly may include, for example, threading all extension rods the same direction. Optionally, assembly may be accomplished without reversing orientation of the assembly during assembly and/or adding other complimentary work such as welding, riveting, plastic deformation Etc.
In some embodiments, a series of extension rods may be threaded together. For example for each rod in the series, a leading end of an interior rod may be threaded may be threaded through into a rear end of a more exterior rod. As used herein, the term/phrase leading end means the end of a TSA from which the inner rod projects in the extended state. As used herein, the term/phrase rear end means the end of a TSA from which the outer rod projects in the extended state. As used herein, the term/phrase threading means screwing the more interior rod towards the leading direction. As used herein, the term/phrase de-threading means screwing the more interior rod towards the rear of the outer rod. Optionally, the leading end of the most inner rod may include a fastener and/or the rear end of the most external rod may include a fastener.
Developing an effective drug therapy and treatment includes more than simply finding an effective molecule. It includes combination of a safe drug within a suitable container and/or delivery system.
One possible failure is premature detaching and or disengaging of a threaded rod from a TSA of the delivery system. Typically, a rod may have a drive mechanism or an actuator on one end and a thread on the other end. A rod that is screwed to the assembly from the screw side may possibly be disengaged from the assembly in reverse direction. As a TSA is extended, the order of extension may sometimes become inverted causing the threads of one element to become disengaged before the assembly is completely extended. As result, the TSA may fail to extend completely resulting in failure to deliver a full dose of the drug.
Another source of failure of a TSA is errors and/or imprecision in the TSA assembly process. For example, a complex assembly processes and/or low precision modification of the parts during assembly may decrease the reliability of a TSA.
An aspect of some embodiments of the invention relates to providing a TSA that resists disengagement and/or detaching of extension rods upon extension. For example, an internal rod of the TSA may include a flange on its rear end. The flange may prevent disengagement from a more outer rod. Alternatively or additional the flange may be replaced by a protrusion of a different geometry.
An aspect of some embodiments of the invention relates to providing a TSA that is assembled from molded parts. In some embodiments, molding provides highly precise part geometries. Molded parts may optionally be assembled with minimal modifications during assembly. For example, the assembly of the TSA may be include minimal or no adhesion of parts, and/or changing of part geometries by heat and/or ultrasonic means and/or by force (for example by crimping). The molded parts may optionally include features to facilitate proper orientation. The molded parts may optionally include built in connectors and/or fasteners (for example snaps, latches, catches, hooks, clasps and the like). In some embodiments that parts may be molded of plastic. For example plastic may include low friction materials. Example of such materials includes for example CELANEX® (for example 2405 MT) available from TICONA and Delrin® (for example 100AL NC010) by DuPont™.
In some embodiments an internal rod may be molded in a single piece with the rear flange and/or projections. The flange and/or projection may optionally impeded unintentional disengagement of the rod. In some embodiments a part may be molded in a single piece with a fastener. In some embodiments a part may be molded in a single piece with a stopper.
An aspect of some embodiments of the invention relates to a stopper that may stop rotation of a TSA. For example a protrusion molded into an end cap may interact with a corresponding protrusion molded into an adjoining end of an extension rod to stop rotation of the rod and/or of a plurality of rods at a predefined point. For example, the stopper may prevent thread lock and or dethreading of the TSA after the TSA reaches a contracted state
An aspect of some embodiments of the invention relates to an end cap shoulder which supply support to a TSA in a syringe. For example a driver may include a shoulder which is inserted into the bore of a syringe to provide support for the outer end of the TSA: The shoulder may optionally rotate in the syringe bore. Optionally, the space for the shoulder may be counter sunk into the syringe flange. Countersinking the shoulder may save space in the syringe bore for the TSA.
Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth in the following description and/or illustrated in the drawings and/or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.
In some embodiments, some or all of the extension rods of the assembly may optionally be supplied disassembled from the end caps. For example, the some or all of the rods and/or end caps may include fasteners. The extension rods may optionally be supplied with flanges inhibiting disassembly due to overextension. For example, an internal rod may have a flange on a rear end. The flanges and/or fasteners may optionally be intrinsic. For example, the rods and/or caps may be molded in a single piece with the fasteners and/or flanges.
In some embodiments, some or all of the extension rods assembled together by reverse extension. For example, a leading end of an internal rod may be threaded into a rear end of a more external rod. For example, the internal rod may be threaded from a disassembled (reverse extended) position through its contracted position out the leading end of a mating rod to an extended position. In some embodiments, threading from the reverse extended position may be necessary because flanges which prevent the rods from disattaching in the extended state may also prevent attaching the rods in the extended state and threading them to the contracted state.
In some embodiments, a fastener may be supplied on a leading end of an inner rod. Once the leading end of an inner rod extends beyond the mating rod, an end cap (for example a driver and/or an actuator) may be fastened to the fastener. Optionally a stopper may be supplied. For example the stopper may block dethreading back to the reverse extended position and/or may prevent thread lock resulting from collision between a rod and an end cap.
Referring now to the drawings,
In some embodiments, the leading end of the inner rod along with the middle rod may be threaded 104 into a rear end of an outer rod. Threading 104 be continued 106 until the leading end of the inner rod protrudes out the leading end of the outer rod. Optionally the assembly may include only two rods and/or more than three rods (for example four, five, six or more rods). In some embodiments, regardless of the number of rods, the assembly of rods may have a fastener of the inner rod protruding from the leading end and a fastener of an outer rod protruding from the rear end (for example see
In some embodiments, an actuator cap (for example cap 324 of
In some embodiments, a driver cap (for example cap 334 of
In some embodiments, after assembly, the TSA may be dethreaded 112 to a stop position. Optionally, the TSA may include one or more stoppers. For example a pair of stoppers on the two end caps (for example the drive cap and the actuator cap) may meet at a predefined point in the contraction of the TSA and prevent further relative rotation in the dethreading direction of the inner rod with respect to the outer rod thereby preventing further contraction (for example see stoppers 332 and 332″ of
In some embodiments, a TSA may be simple assembled unidirectionally from a reverse extended position. The assembled TSA may optionally resist dis-assembly by extension.
Referring now to the drawings,
In some embodiments expansion and contraction of the TSA may be effected by a series of threaded rods. For example, an inner rod 220 may be threaded into a rear end of a mid rod 230 which may optionally be threaded into a rear end of an outer rod 240. In the exemplary embodiment of
In some embodiments a rod may include a member to prevent disengagement of the rod during extension of the TSA. For example inner rod 220 includes a rear flange 226 and mid rod 230 includes a rear flange 226′. When rod 220 reaches full extension, flange 226 contacts interior threads 229′ of mid rod 230 preventing further extension (see
In some embodiments, a TSA may include stop element. For example,
In some embodiments, after threading together the extension rods, end caps may be attached. For example, actuator mount 224 and/or actuator 222 may be attached to a leading end of inner rod 220 (as illustrated by the broken arrow in the left side of
Referring now to the drawings,
In the example of
In the example of
Referring now to the figures,
Referring now to the figures,
In the illustrative example of
In the illustrative example of
In the illustrative example of
In the illustrative example of
In the illustrative example of
Referring now to the figures,
In some embodiments counter sunk cavity 657 may be wider than the bore of syringe 645. Optionally shoulder 642 may be wider than the bore of the syringe. Optionally making shoulder 642 wider than the syringe bore may make it possible to make more complete use of the bore for expansion rods of TSA 600.
Referring now to the figures,
In some embodiments, one or more end caps may be attached 766 to the extension rods. Attachment of end caps may optionally be irreversible (alternatively or additionally attachment 766 of end caps may be reversible).
In some embodiments, the end caps may inhibit return of the telescoping assembly to the reverse extended state and/or separating of the extension rods. For example, the end caps may block dethreading of the extension rods beyond the contracted state to the reverse extended state and eventually detached state. Alternatively or additionally, an end cap may include a stopper the stops movement in a certain direction of an extension rod at a certain point. For example, a stopper may prevent dethreading when an extension bar and/or the TSA reach a fully contracted state. Alternatively or additionally, the stopper may prevent further threading into super extension when the TSA reaches a fully extended state.
In some embodiments, with extension rods assembled and the end caps attached 766 the TSA can be reversibly extended 768′ and/or contracted 768.
In some embodiments, the TSA will be contracted 768 and attached 770 to the plunger of a syringe. Optionally attachment 770 to a syringe may be irreversible. Alternatively or additionally attachment 700 to a syringe may be reversible.
In some embodiments, a syringe and attached TSA will be distributed 771 to a patient, for example as components of a patch injector. The patient may activate the injector, extending 772 the TSA to inject a drug. In some embodiments, extension of the TSA for discharging the drug will be irreversible. For example, after discharging the drug to the patch injector and/or the TSA and/or the syringe may be disposable. Alternatively or additionally, some or all components of a patch injector and/or TSA and/or syringe may be reusable.
Extension rods 820 and 840 of
It is expected that during the life of a patient maturing from this application many relevant fasteners and/or other relevant parts will be developed and the scope of the terms fattener and/or other terms are intended to include all such new technologies a priori.
As used herein the term “about” refers to ±5%.
The terms “comprises”, “comprising”, “includes”, “including”, “having” and their conjugates mean “including but not limited to”.
The term “consisting of” means “including and limited to”.
The term “consisting essentially of” means that the composition, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.
As used herein, the singular form “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.
Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging/ranges between” a first indicate number and a second indicate number and “ranging/ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.
It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.
Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.
All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.
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Number | Date | Country | |
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20130304021 A1 | Nov 2013 | US |