Patent Application
20210128823
The treatment of a variety of diseases necessitates repeat or prolonged delivery of an agent by injection and such injections can be performed using specialized injection devices. Such injector devices may deliver relatively large volumes containing the medicament, including volumes of approximately at least one milliliter and including a few milliliters. Injection of such large volumes of medicament may be over the course of many minutes and even up to a few hours. Generally such devices are operated by the patients themselves, although they may also be operated by medical personnel.
Typically, the initiation is effected by the user operating an electrical switch, which causes a controller to operate the device. Operation includes injecting a needle into the user and then causing the injection of medicament into the user's tissue. Biological medicaments are being increasingly developed which comprise higher viscosity injectable liquids and which are to be administered in larger volumes than long-known liquid medicaments.
Particularly in the case of patient-operated devices, which require insertion of a drug cartridge prior to use, the drug delivery process from start to finish can be a complicated multi-step process, including gathering of all of the device components, assembly of the components to produce the device ready for drug administration and sterilization of the injection site before the actual process of injecting the drug can even begin.
For example, the preparation step includes sourcing a sterilizing liquid and a sterilizing swab to apply the sterilizing liquid. The sterilizing liquid then needs to be applied over the intended injection site on a patient's body to ensure the injection site is fully sterilized, and the sterilizing materials then put aside or discarded before a medicament administration procedure can be commenced. Gathering all these materials and performing the sterilizing process is time-consuming and burdensome, and adds complication to the process for the patient. This renders the process intrusive upon his or her daily schedule, and increases the risk that the patient may not correctly perform the drug administration.
There are also limitations as to the maximum volume of liquid medicament one injection site can accept within a predetermined amount of time without causing the patient discomfort, pain, inhibiting pharmacokinetics or causing leakage out of the injection site. To avoid complications of such interactions between the drug and the patient's body, such large-volume biological medicaments should not be administered at the same injection site on the patient's body twice or more in succession. Therefore, this is another factor in the medicament administration process which the patient must take into consideration.
Other aspects of existing designs for cannula insertion devices that are unsuitable include steps that require the user to manually insert the cannula, or do not automatically retract the insertion needles.
It is therefore an aim of the invention to provide a medicament delivery device which is simple to use and helps to reduce the risk of incorrect use by a user and may be more ideal for use with large volumes and viscous materials
It is an objective of the present invention to provide a prefilled selectively activatable body-worn infusion-pump assembly for rapid delivery of large volumes or highly viscous volumes.
It is a further objective of the present invention to provide the prefilled selectively activatable body-worn infusion-pump assembly comprising an aseptically pre-filled drug reservoir, a fluid connection means and a cannula insertion means where the assembly can be fitted to the rest of the infusion-pump components while maintaining sterility and requiring no actions on the part of the end user other than removing the cannula protection cap, adhering the assembled device onto the injection site and pressing a button.
It is an objective of the present invention to provide a prefilled selectively activatable body-worn infusion-pump assembly containing a low profile mechanism that upon a triggering action by the user, inserts a subcutaneous cannulated needle, which in some aspects, automatically retracts the needle component in a simple and efficient manner.
It is another objective of the present invention that the operation of a single button performs all drug delivery device operations.
It is another objective of the present invention that in the absence of appropriate orientation of the skin sensor, activator initiation and thereby drug delivery is prevented.
It is another objective of the present invention that the operation of the needle piercing the drug container septum is simultaneously or essentially simultaneously accompanied by subcutaneous insertion of the cannulated needle and pump activation.
It is another objective of the present invention that the operation of a single button performs or promotes operation of the needle piercing the drug container septum, pump activation and cannula insertion mechanism triggering and adaptations of said single button facilitate simultaneous or essentially simultaneous, i.e. rapid sequential activation of the three operation steps so that opening of a fluid path, drug pumping from a reservoir and cannula insertion and drug delivery therethrough are provided in a controlled and regulated manner.
In some aspects, such single button activation mechanism provides for drug dispensing in a simple manner, requiring no further involvement of the patient in promoting drug delivery other than pushing a button.
This invention provides a prefilled selectively activatable infusion-pump assembly comprising:
In some aspects, the conjoined, coordinately controlled and perpendicularly arranged cannulated needle dispensing and needle insertion assembly are arranged in an orientation that is substantially perpendicular with respect to each other.
In some embodiments, deployment of the cannulated needle dispensing assembly is controlled by one or more springs operationally attached thereto. In some aspects, such springs are in a compressed state prior to activation, whereupon release of same results in deployment of the cannulated needle dispensing assembly. In some aspects, the needle and cannula components of the dispensing assembly are separately addressable via a first and second spring, respectively, such that needle retraction is regulated individually via the first spring, while cannula insertion is maintained.
In some embodiments, the first spring is separately retractable after deployment of said second spring.
In some embodiments, the prefilled selectively activatable infusion-pump assembly further comprises:
In some embodiments, the single step activator comprises an element engaging an element which promotes closure of a circuit on said PCB assembly thereby activating said engine assembly. In some embodiments, the single step activator comprises a movable element such that said engine assembly is engaged upon deployment of said single step activator and in some embodiments, the single step activator comprises an element engaging an electronic switch activation surface of said engine assembly, powering same.
In some aspects, the PCB assembly operationally controls function of an indicator light or sound relay system, such that the user receives feedback via indicator light or sound when the device is operational, or in some embodiments, when the device is not operational. In some embodiments, additional user instructions may be imparted to the user via use of the indicator light and/or sound relay system.
In some aspects, the single step activator comprises a laterally moving part operationally connected thereto, whose lateral movement removes a blockade of said needle insertion assembly opening a fluid path with said pre-filled aseptically-sealed drug reservoir-containing assembly; said cannulated needle dispensing assembly inserting in a skin of a subject, or a combination thereof.
In some aspects, the single step activator cannot be engaged or deployed as long as a skin sensor device detects that said prefilled selectively activatable infusion-pump assembly is not properly positioned on a skin of a subject.
In some aspects, the needle insertion assembly pierces a septum comprising ribbing on an outer surface of said septum, protrusions around a bore of either face of said septum, or any combination thereof.
This invention also provides a prefilled selectively activatable infusion-pump assembly comprising:
In other embodiments, this invention provides a prefilled selectively activatable infusion-pump assembly comprising:
In some embodiments, the worm gear comprises a thrust bearing surface disposed of distally from a floating motor shaft connection that is supported by the chassis rather than the motor shaft.
In some embodiments, the assembly further comprises a single step activator that when engaged simultaneously promotes:
In some embodiments, the single step activator comprises a laterally moving part operationally connected thereto, whose lateral movement removes a blockade of said needle insertion assembly opening a fluid path with said pre-filled aseptically-sealed drug reservoir-containing assembly; said cannulated needle dispensing assembly inserting in a skin of a subject, or a combination thereof. In other embodiments, the single step activator comprises a movable element such that said engine assembly is engaged upon deployment of said single step activator. In other embodiments, the single step activator comprises an element engaging an electronic switch activation surface of said engine assembly, powering same. In some embodiments, the single step activator comprises an element engaging an element which promotes closure of a circuit on said PCB assembly thereby activating said engine assembly. In some embodiments, the single step activator cannot be engaged or deployed as long as a skin sensor device detects that said prefilled selectively activatable infusion-pump assembly is not properly positioned on a skin of a subject.
In some embodiments, the cannulated needle dispensing and needle insertion assembly are conjoined, coordinately controlled and perpendicularly arranged. In some embodiments, the cannulated needle dispensing assembly promotes insertion of a cannulated needle into a skin of a subject and promotes retraction of said needle within said cannulated needle dispensing assembly thereafter.
In some embodiments, the cannulated needle dispensing assembly comprises concentric arrangement of a needle hub securing said insertion needle and a bushing separately securing said cannula in said assembly. In some embodiments, the cannulated needle dispensing assembly comprises a first spring, retractable within said assembly, which when released from a compressed state propels said insertion needle downward and a second differentially addressable spring, retractable within said assembly, which when released from a compressed state propels said cannula downward. In some embodiments, the first spring is separately retractable after deployment from said second spring. In some embodiments, the needle insertion assembly pierces a septum comprising ribbing on an outer surface of said septum, protrusions around a bore of either face of said septum, or any combination thereof.
The invention provides a number of prefilled selectively activatable infusion-pump assemblies. The term “selectively activatable” is to be understood to refer to a requirement for an activation step, i.e., a specific action to be taken to produce the outcome. For example, and representing some embodiments, the term “selectively activatable infusion pump assembly” is to be understood to encompass an assembly whose delivery of the drug via known/described mechanisms, is regulated such that an activation step is required or delivery from the infusion pump is prevented.
In some aspects, such activation step is mediated/regulated via the single step activator, which in some aspects is itself subject to regulation via the skin sensor as described herein.
The prefilled selectively activatable infusion-pump assemblies of this invention comprise a housing.
In some embodiments, the housing will be comprised of any suitable material and will be constructed by conventional means, as will be appreciated by the skilled artisan.
In some aspects, the housing may comprise an indicator light, which in some aspects, provides a selective indicator indicating the device being ready for deployment/engagement of the single step activator. In some aspects, the housing may comprise an indicator light that changes color, as a function of whether the device is ready or not for deployment/engagement of the single step activator. In some aspects, the housing may comprise a sound relay system, which in turn provides an audio feedback, serving as an indicator for the device being ready for deployment/engagement of the single step activator. In some aspects, the sound relay system may change the audio indicator emitted, as a function of whether the device is ready or not for deployment/engagement of the single step activator.
In further aspects, the housing may comprise a series of recesses or posts, or other physical buttresses to accommodate and house the various components of the prefilled selectively activatable infusion-pump assembly.
In further aspects, the housing may comprise an observation window, which provides the user with an interior view to provide an indication as to whether the device is deploying/functioning properly.
In some aspects, the housing further comprises at least one basal adhesive panel. In some embodiments, the housing basal surface may be affixed to the skin of a user for deployment, whereby the basal surface comprises at least one panel which contains an adhesive surface, which adheres to the skin of a user. In some aspects, two or more such panels may be incorporated on the basal surface, as needed.
Such adhesive surfaces may be comprised of any suitable adhesive material for affixing the device to the skin of a user, for example as described in European Patent Application Numbers 0413250 or 0092999.
In some aspects, the housing is provided in a water-resistant or splash proof manner, incorporating, for example appropriate gaskets to ensure appropriate sealing. In some aspects, the housing is so constructed to safely incorporate the sterile fluid path components, maintaining sterility of the inner delivery path components.
In another aspect, the housing may further comprise an activation switch, which in some embodiments, is moved laterally, following engagement of the single step activator, which in turn promotes propulsion of the needle insertion assembly opening a fluid path with said pre-filled aseptically-sealed drug reservoir-containing assembly as well as propulsion of the cannulated needle dispensing assembly toward a skin of a subject. In some aspects, the activation switch engagement, for example, via lateral movement, specifically removes a physical blockade previously preventing propulsion of the needle insertion assembly, propulsion of the cannulated needle dispensing assembly, or a combination thereof.
In some aspects, the activation switch may be adapted to comprise an external element for easy implementation, such as a slide switch, or push button, or any other mechanism as will be appreciated, by the skilled artisan.
In some aspects, the “push button” or other externally located relay may comprise a sealing to prevent compromise of sterility of internally located elements in the device, or in some embodiments, the sealing renders the device water-resistant or water proof, or a combination thereof.
In some aspects, the “push button” or other externally located relay may comprise further adaptations or modifications to engage the simultaneous opening of a fluid path with said pre-filled aseptically-sealed drug reservoir-containing assembly, insertion of said cannulated needle in skin of a subject and promoting retraction of said needle within said cannulated needle dispensing assembly thereafter and activation of said engine assembly to promote concerted opening of the fluid path, initiation of drug delivery from the pre-filled aseptically-sealed flexible drug reservoir-containing assembly and piercing of the subject skin to promote delivery thereto.
According to this aspect, and in some embodiments, the “push button” or other externally located relay may comprise further adaptations or modifications to interface with an element of the cannulated needle dispensing and needle insertion assembly, for example, serving as a trigger interface for same.
According to this aspect, and in some embodiments, the “push button” or other externally located relay may comprise further adaptations or modifications to interface with an element of the engine assembly, or in some embodiments, with an electronic switch activation surface, powering same.
According to this aspect, and in some embodiments, the “push button” or other externally located relay may comprise further adaptations or modifications to interface with an element of the skin sensor device, such that when same is moved to the appropriate position, the push button is now freely depressed/engaged.
According to this aspect, and in some embodiments, the “push button” or other externally located relay may comprise further adaptations or modifications, such as, for example specialized guides, which in turn allow coordinated action of the various aspects as described hereinabove.
In some aspects, in reference herein to the single step activator promoting:
In some aspects, the skin sensor prevents accidental operation of the button before the device is placed on the user. In some embodiments, the skin sensor provides a mechanical block for the full deployment/activation of the activator switch, such that unless the sensor is positioned properly on the skin, it is not possible to engage/deploy the activator switch.
In some aspects, the cannula cap may be made of any convenient sterilizable material, and may be further modified to contain a convenient user grip for removal. According to this aspect, and in some embodiments, the cannula cap will be of any appropriate size in terms of length, width, as will be convenient for packaging and ease of manipulation by the user.
In some embodiments, the cannula cap may promote a sealed container maintaining sterility of the cannulated needle dispensing assembly and thereby maintaining sterility of the drug path. In some aspects, the cannula cap may promote inadvertent injury by the user's premature exposure to the cannulated needle dispensing assembly.
In some aspects, this invention provides a pre-filled aseptically-sealed flexible drug reservoir-containing assembly. In some aspects, the pre-filled aseptically-sealed flexible drug reservoir-containing assembly comprises a thin profile reservoir that can hold large volumes of drug solution with less than 10%, or in some embodiments, less than 9%, or in some embodiments, less than 8%, or in some embodiments, less than 7%, or in some embodiments, less than 6%, or in some embodiments, less than 5% residual volume after delivery.
In some aspects, the pre-filled aseptically-sealed flexible drug reservoir-containing assembly comprises a container containing about 5 mL of drug solution, with less than about 0.3 mL residual volume after completion of the delivery cycle.
In some aspects, the pre-filled aseptically-sealed flexible drug reservoir-containing assembly can withstand high pressures and is thereby able to deliver high-viscosity drug formulations in within short time periods. According to this aspect, and in some embodiments, the pre-filled aseptically-sealed flexible drug reservoir-containing assembly can deliver high-viscosity drug formulations within a sterile drug path with linearity and in some embodiments, 10%, or in some embodiments, 9%, or in some embodiments, 8%, or in some embodiments, 7%, or in some embodiments, 6%, or in some embodiments, 5% accuracy with respect to the delivery rate.
According to this aspect, and in some embodiments, the pre-filled aseptically-sealed flexible drug reservoir-containing assembly can deliver high-viscosity drug formulations within a sterile drug path with linearity and in some embodiments, 10%, or in some embodiments, 9%, or in some embodiments, 8%, or in some embodiments, 7%, or in some embodiments, 6%, or in some embodiments, 5% accuracy with respect to the delivery dose.
In some aspects, the pre-filled aseptically-sealed flexible drug reservoir-containing assembly specifically comprises a deeper baseplate and filling channel while maintaining a slim profile housing.
In some aspects the deeper filling channel, in turn provides for the filling nozzle to penetrate through the container during filling and in some embodiments, provides the advantage of reduced foaming of the drug substance and in some embodiments, provides an advantage in terms of faster filling, or both.
According to these aspects, and in some embodiments, the internal volume in the container is larger than 3 ml and a slim profile for same is maintained. In some aspects, the deeper baseplate accommodates increasing the internal volume in the container.
The prefilled selectively activatable infusion-pump assembly will comprise a conjoined, coordinately controlled and substantially perpendicularly arranged cannulated needle dispensing and needle insertion assembly.
In some aspects, this invention provides a conjoined, coordinately controlled and perpendicularly arranged cannulated needle dispensing and needle insertion assembly operationally connected to and in fluid connection with a pre-filled aseptically-sealed drug reservoir-containing assembly, wherein said cannulated needle dispensing assembly projects generally perpendicularly to a generally planar surface of said housing, promotes insertion of a cannulated needle in skin of a subject and promotes retraction of said needle within said cannulated needle dispensing assembly thereafter, and wherein said needle insertion assembly projects generally in a parallel orientation to a generally planar surface of a housing containing same, which projection initiates opening a fluid path with said pre-filled aseptically-sealed drug reservoir-containing assembly.
In some embodiments, the cannulated needle dispensing assembly comprises:
In some embodiments, the needle insertion assembly propels a needle or any similarly appropriate penetrating structure toward the sealed prefilled drug-reservoir, thereby facilitating penetration of the drug-reservoir conduit opening a fluid path for same. In some embodiments, a specialized septum configured to be between the insertion assembly and sealed prefilled drug-reservoir is pierced by the needle or similarly appropriate penetrating structure as it is propelled therethrough toward the sealed prefilled drug-reservoir.
In some aspects, this invention provides a low profile mechanism, which upon a triggering action by the user, inserts a subcutaneous cannulated needle and then automatically retracts the insertion needle.
In some aspects, the conjoined, coordinately controlled and perpendicularly arranged cannulated needle dispensing and needle insertion assembly relies on a concentric arrangement of a needle hub that secures the insertion needle and an outer hub that secures the cannula. The mechanism operates with two distinct set of springs whose force is tuned to their respective roles. The thus described orientation ensures that both the cannula insertion and insertion needle retraction actions are highly reliable and allows the device to be assembled with both springs in the compressed state, which allows for a low profile mechanism that can fit within the patch pump housing. In some aspects, upon retraction, the insertion needle completes the fluid path connection with the channel in the top of the insertion mechanism housing.
In some aspects the cannulated needle dispensing and needle insertion assembly is a single unit with two functional elements, which are conjoined and coordinately controlled. In some aspects, the term “conjoined” refers to a structural attachment between the two parts, which in some embodiments, is physically associated or in some embodiments, bonded, or in some embodiments, created as a single unit.
The cannulated needle dispensing and needle insertion assembly are arranged in an orientation that is substantially perpendicular with respect to each other.
In some aspects, the cannulated needle dispensing assembly projects generally perpendicularly to a generally planar surface of the housing and promotes insertion of the cannulated needle into skin of a subject and promotes retraction of the needle within the cannulated needle dispensing assembly thereafter.
In some aspects, the needle insertion assembly projects generally in a parallel orientation to a generally planar surface of the housing, which projection initiates opening a fluid path with the pre-filled aseptically-sealed drug reservoir-containing assembly.
In one aspect, the cannulated needle dispensing element comprises a concentric arrangement of a needle hub securing said needle and a bushing separately securing said cannula in said cannulated needle dispensing assembly.
In some aspects, such mechanism operates with two distinct sets of springs whose force is tuned to their respective roles.
Such arrangement ensures that both the cannula and needle insertion and independent needle retraction actions are highly reliable and in some embodiments, allows the device to be assembled with both springs in the compressed state, which in still further aspects, allows for a low profile mechanism that can fit within the low profile housing.
Such arrangement promotes sequential triggering of the sequence for activation of the cannulated needle dispensing element without need for use of additional external triggers to effect same. In some aspects, the fact that the steps are conducted sequentially improves reliability, as one spring is deployed thereby completing its role and only following same is the second spring deployment initiated.
According to this aspect, and in some embodiments, the cannulated needle dispensing assembly comprises a first spring, retractable within the assembly, which when released from a compressed state propels the needle of the cannulated needle dispensing assembly downward and a second differentially addressable spring, retractable within the assembly, when released from a compressed state propels the cannula downward. According to this aspect and in some embodiments, the first spring is separately retractable after deployment from the second spring.
In some aspects, the needle insertion assembly, whose projection initiates opening a fluid path with the pre-filled aseptically-sealed drug reservoir-containing assembly, pierces a septum designed to ensure sterile closure of the pre-filled aseptically-sealed drug reservoir-containing assembly. In some aspects, such septum is designed to deliver high viscosity drug formulations in relatively short periods of time, such that said septum consistently allows for secure and sterile closure of the aseptically filled reservoir, resisting the high pressures generated during operation of the device. In some aspects, such septum is designed to allow for the needle insertion assembly to consistently pierce the septum with relatively low force and without such deflection that it would make contact with the walls of the reservoir or its neck.
In some aspects, such septum is so designed with specially shaped outer and inner faces, to comprise ribs on its outer circumference, and in some embodiments, protrusions around the bore on both faces of such septum and in some embodiments, a combination thereof. According to this aspect, and in some embodiments, such structural modifications minimize insertion force, while at the same time eliminating undesired needle deflection during the fluid connection operation while maintaining ease of making a robust sterile closure of the aseptically filled container.
In some aspects, such control of needle deflection facilitates accurate needle placement and promotes for a more ideally shallow channel in the baseplate of the drug reservoir thus minimizing residual volume.
The prefilled selectively activatable infusion-pump assembly further comprises an engine assembly contained in said housing operationally connected to said pre-filled aseptically-sealed flexible drug reservoir-containing assembly promoting release of a drug contained therein, wherein said engine assembly comprises:
It will be appreciated that the term “worm gear” is to be understood as its art-recognized meaning. The term “worm gear” will refer, inter alia, to a mechanical arrangement consisting of a toothed wheel worked by a short revolving cylinder (worm) bearing a screw thread. In some aspects, the worm gear will be understood to comprise a threaded shaft (worm) that mates with a gearwheel (worm wheel) so that rotary motion can be transferred between two shafts at right angles to each other.
In some aspects, the worm gear serves to reduce rotational speed and/or transmit higher torque.
It is a further objective of the invention to provide a prefilled selectively activatable infusion-pump assembly containing a worm gear drive system that transmits high forces to a drive gear from a motor having a planetary gear reduction system, i.e. isolating a sensitive planetary gear from axial and radial forces. The system allows for the easy assembly of an injection molded worm gear that exhibits low friction when transmitting strong loads to a drive gear while isolating the sensitive planetary reduction gear system of the drive motor from strong thrust loads.
In some aspects, the prefilled selectively activatable infusion-pump assembly is so constructed so as to ensure that there is neither axial nor radial load placed on the motor, which in turn ensures that only torque is transferred in engagement of the motor and worm gear.
According to this aspect, and representing embodied aspects of the invention, with regard to the mechanical interfaces within the motor-worm-chassis assembly, in some aspects, there exists a loose connection between the worm gear and the motor, and in some embodiments, there exists a loose connection between the worm gear and the chassis proximal to the motor shaft.
In some aspects, there exists a tight connection between the motor and the chassis elements constraining same. In some aspects, there exists a tight connection between the worm gear and the distal connection to the chassis (i.e. distal to the connection to the point of connection near the motor shaft).
It is an objective of this invention to provide a worm gear having a thrust bearing surface disposed of distally from a floating motor shaft connection that is supported by the chassis rather than the motor shaft. The floating attachment combined with the placement of the thrust bearing surface allows for enough radial displacement of the worm gear during operation as not to transmit damaging radial or longitudinal forces to the motor's planetary gear reduction system while ensuring there is minimal longitudinal play as not to affect the precision of the drive gear rotation. The single thrust bearing surface and floating attachment of the worm to the motor shaft also allows for the simple alignment of the parts during assembly.
The selectively activatable infusion-pump assembly further comprises a lifting gear operationally connected to the worm gear.
In some aspects, the term “lifting gear” refers to any thus designated element that can be used to lift loads. According to this aspect, the lifting gear specifically promotes lifting of the piston, which in turn applies a desired force to the pre-filled aseptically-sealed flexible drug reservoir-containing assembly, to promote controlled delivery of the contents of same to the subject, once the fluid path between the pre-filled aseptically-sealed flexible drug reservoir-containing assembly and conjoined, coordinately controlled and perpendicularly arranged cannulated needle dispensing and needle insertion assembly is opened.
In some aspects, the selectively activatable infusion-pump assembly further comprises a piston operationally connected to the lifting gear, which in turn, as described applies a force to the pre-filled aseptically-sealed flexible drug reservoir-containing assembly, to promote controlled delivery of the contents of same to the subject, once the fluid path between the pre-filled aseptically-sealed flexible drug reservoir-containing assembly and conjoined, coordinately controlled and perpendicularly arranged cannulated needle dispensing and needle insertion assembly is opened.
In some aspects, the selectively activatable infusion-pump assembly further comprises a chassis fitted with an attachment promoting a floating connection with the worm gear wherein the worm gear and motor are mounted radially with respect to the chassis.
In some aspects, the selectively activatable infusion-pump assembly further comprises a printed circuit board (PCB) assembly, which mechanically supports, electrically connects and controls the function of at least the engine assembly.
It is a further object of the invention to ensure that the pre-filled drug-reservoir remains sealed or that a sterile unit containing such drug reservoir be maintained as such, until directly before the activation of the patch-pump, such that the only materials that come in contact with the drug are the plastic and/or glass from which the reservoir is fabricated and one or more septa.
It is a still further object of the invention to open said fluid connection while keeping the operation of said patch-pump as simple as possible and requiring an essentially single activation-step.
According to this aspect, and as referred to herein the term “selectively activatable” is to be understood to refer to a requirement for an activation step, i.e., a specific action to be taken to produce the outcome.
According to this aspect, and in some embodiments, the cannula-containing assembly provides for the delivery of the drug-containing substance liberated from the drug reservoir. In some embodiments, such cannula-containing assembly comprises a part capable of piercing the skin. In some embodiments, such cannula-containing assembly may resemble a venicath or similar structure, which provides for skin puncture to promote subcutaneous delivery. In some embodiments, such catheter-containing part may be flexible or rigid.
In some embodiments, the prefilled selectively activatable infusion-pump assembly comprises a pre-filled aseptically-sealed flexible drug reservoir-containing assembly, which is essentially a thin profile reservoir-containing assembly that can hold large volumes of drug solution with less than 5% residual volume after delivery. For example, and in some embodiments, the drug reservoir-container holds approximately 5 mL of drug solution with less than 0.3 mL residual volume after completion of the delivery cycle. In some aspects, the drug reservoir-container is so constructed so as to withstand high pressure, while facilitating delivery of high-viscosity drug formulations in within short time periods and delivery of same is within a sterile drug path with linearity with respect to the delivery rate.
In some aspects, the invention provides for pre-filled aseptically-sealed flexible drug reservoir containing a deep baseplate, which in some embodiments, is up to 1 mm, or in some embodiments, up to 2 mm, or in some embodiments, up to 3 mm, or in some embodiments, up to 4 mm, or in some embodiments up to 5 mm in depth. In some aspects, the additional clearance does not adversely impact the linearity of drug delivery
In some embodiments, the pre-filled aseptically-sealed flexible drug reservoir is attached, 1-3 mm or in some embodiments, 2-3 mm above the floor of the baseplate, or in some embodiments, such attachment is at a sufficient height above the floor of the baseplate to promote “double-flip” operation of same.
In some aspects, the prefilled selectively activatable infusion-pump assemblies of this invention provide for the ability to prepare an aseptically pre-filled drug reservoir, a fluid connection means and a cannula insertion means where the assembly can be fitted to the rest of the described components while fully maintaining sterility of the assembly and its component parts. In some aspects, there is no action on the part of the end user for initiating delivery in the devices of this invention other than removing the cannula protection cap, adhering the assembled device onto the injection site and pressing a button, while full sterility is maintained.
In some aspects, uniquely the invention provides a means of specific combination of steps that first assembles a sterilized drug reservoir that is aseptically filled, connects same to a pre-sterilized drug path connection system and cannula insertion system and further assembles same within the device housing, to create a functional drug delivery device such that the end user needs only to expose an adhesive surface, remove the cannula cap, adhere the device to the injection site and press a button in order to complete the injection process. Uniquely the invention provides for independent end user obtaining a packaged prefilled selectively activatable infusion-pump assembly of this invention, and independent sole initiation of drug delivery with a single push button device, where no additional medical personnel intervention is required.
Some embodied contemplated devices are explained more fully below, in connection with the figures, but the same shall not be construed as limiting the invention.
All publications, patents, and patent applications mentioned herein are hereby incorporated by reference in their entirety as if each individual publication or patent was specifically and individually indicated to be incorporated by reference. In case of a conflict between the specification and an incorporated reference, the specification shall control. Where number ranges are given in this document, endpoints are included within the range. Furthermore, it is to be understood that unless otherwise indicated or otherwise evident from the context and understanding of one of ordinary skill in the art, values that are expressed as ranges can assume any specific value or sub-range within the stated ranges, optionally including or excluding either or both endpoints, in different embodiments of the invention, to the tenth of the unit of the lower limit of the range, unless the context clearly dictates otherwise. Where a percentage is recited in reference to a value that intrinsically has units that are whole numbers, any resulting fraction may be rounded to the nearest whole number.
This invention provides a prefilled selectively activatable body-worn infusion-pump assembly for rapid delivery of large volumes and/or highly viscous volumes.
In some aspects, the prefilled selectively activatable body-worn infusion-pump assembles of this invention comprise an aseptically pre-filled drug reservoir, a fluid connection means and a cannula insertion means where the assembly can be fitted to the rest of the infusion-pump components while maintaining sterility and requiring no actions on the part of the end user other than removing the cannula protection cap, adhering the assembled device onto the injection site and pressing a button.
In some embodiments, the invention provides a prefilled selectively activatable body-worn infusion-pump assembly containing a low profile mechanism that upon a triggering action by the user, inserts a subcutaneous cannulated needle, which automatically retracts the insertion needle in a simple and efficient manner. In some aspect, the operation of a single button performs all drug delivery device operations.
This invention provides a prefilled selectively activatable infusion-pump assembly comprising:
Referring to
In one aspect, the assembly may comprise an indicator light 1-40 or sound relay, observation window 1-50, elements of which may in some aspects, be observed in the top cover of the housing, and in other aspects on the side or bottom of same. In some aspects, the elements, such as the indicator light or sound relay system, may comprise components on the PCB for regulated activation/signaling via same.
In another aspect, the bottom cover 1-30 provides a top view of a skin sensor 1-60.
As can also be seen in the figure, there is a pre-filled aseptically-sealed flexible drug reservoir-containing assembly 1-70, engine assembly 1-80, conjoined, coordinately controlled and perpendicularly arranged cannulated needle dispensing and needle insertion assembly 1-90 and PCB assembly 1-100.
Referring to
In some aspects, the worm drive connection to the motor via a specialized region that is D-shaped specifically connects to the motor shaft, which itself is D-shaped. According to this aspect, and in some embodiments, the D shape promotes transfer of rotational movement between parts without slippage.
In some aspects the worm gear engages and thereby rotates the lifting gear via specialized regions 4-320 on the worm gear and appropriately modified interacting components 4-195 on the lifting gear (
In some aspects, a reflecting surface 4-350 may be included.
According to this aspect, and in some embodiments, the proximal device surfaces to the worm gear apparatus will be “painted”, i.e. containing a non-reflective surface, and same facilitates counting the number of rotations of the gear about an axis during operation.
According to this aspect, and in some embodiments, the device further incorporates an optical sensor, positioned in the housing and located below the reflecting surface of the worm gear. Such sensor undergoes a change in signal as a consequence of reflection from the worm gear identified, as a function of reflection off the two reflective surfaces on the worm gear. According to this aspect, with each worm gear full rotation, two optical signals are relayed, and same in turn may be used to control piston speed and infusion rate and to indicate when the infusion has ended.
Thus, for example, referring to the flat region 4-350 described above, located on e.g. opposing outer sides of the worm gear, as depicted, if same are provided in a white color or reflective color, whereas the remaining elements of the worm gear are provided in an absorptive color, e.g. black, then the sensor in some embodiments, will detect a change in reflective signal, which in turn signifies partial rotation. In some aspects of the described herein, a full rotation of the worm drive may produce two “on” or reflective signals, thereby serving as an indicator for rotation of the worm gear.
Importantly, the thrust bearing surface 4-300 is disposed of distally form a floating motor shaft connection that is supported by the chassis rather than the motor shaft. The floating attachment combined with the placement of the thrust bearing surface 4-300 allows for enough radial displacement of the worm gear during operation as not to transmit damaging radial or longitudinal forces to the motor's planetary gear reduction system while ensuring there is minimal longitudinal play so as not to affect the precision of the drive gear rotation. The single thrust bearing surface 4-300 and floating attachment of the worm to the motor shaft 4-340 also allows for the simple alignment of the parts during assembly.
In some aspects, incorporation of simple DC motor is envisioned, whereby same is operationally coupled to the planetary and worm gear, as described, with no axial or radial load being applied to the motor. According to this aspect, and in some embodiments, such arrangement ensures transfer of torque only.
According to this aspect, and in some embodiments, upon electrical activation the motor, worm gear and lifting gear rotate, unscrewing the piston, and in some embodiments, the piston tabs mounted inside the chassis prevent the piston from rotating.
Further according to this aspect, and in some embodiments, there are then four mechanical interfaces within the motor-worm-chassis assembly, and as will be appreciated, the connection between the motor and chassis and worm gear and chassis at the distal end would contain tight connections between same, while the connection between the worm gear and motor and worm gear and chassis proximal to the motor shaft, would be a loose connection.
Both the motor and worm gear, according to this aspect, are inserted sequentially in the chassis for ease of assembly. In some aspects, the worm gear is first inserted into the chassis (e.g. snapped in, using features as depicted by 5-300). According to this aspect, once the worm gear is positioned in place the motor is then inserted, for example, via inserting same in the same linear direction.
Moreover, in viewing
Similarly, various pins to facilitate alignment of other parts to promote proper fitting vis a vis the chassis and underlying PCB assembly, are shown. For example, referring to
As described herein, the motor is operationally connected to the worm gear, which in turn is operationally connected to the lifting gear, which in turn is operationally connected to the piston and this relay system promotes impingement of the piston on the basal surface of the flexible pre-filled aseptically-sealed flexible drug reservoir-containing assembly promoting drug egress therefrom.
Referring to
The prefilled selectively activatable infusion-pump assembly will contain a conjoined, coordinately controlled and perpendicularly arranged cannulated needle dispensing and needle insertion assembly operationally connected to and in fluid connection with the pre-filled aseptically-sealed drug reservoir-containing assembly.
Referring to
As is also noted, the single step activator when engaged simultaneously promotes activation of the needle insertion assembly to open a fluid path with the pre-filled aseptically-sealed drug reservoir-containing assembly and activation of the cannulated needle dispensing assembly inserting in a skin of a subject.
In some embodiments, such single step activator may include an activator button modified to engage a number of other elements to achieve the coordinated controlled deployment of the different systems.
Referring to
According to this aspect, elements of the needle insertion assembly 8-90 and cannulated needle dispensing assembly 8-500 is shown.
In some aspects, the printed circuit board (PCB) assembly 8-100 comprises metal parts or metal coated parts that come into contact e.g. with metal components of the activator assembly and complete a circuit when in contact therewith, such that the PCB assembly is thereby activated and promotes coordinate activation of the engine assembly operationally connected thereto.
Referring now to
Referring to
Spring structures are associated with the cannulated needle dispensing assembly to both propel the cannulated needle assembly downward toward the skin of a subject and to retract the needle after the cannula is stably inserted within the skin of the subject. The springs are referred to as insertion and retraction springs, respectively. The insertion springs attach to the needle bushing at a region so designed to accommodate same, for example as depicted by part 10-525 in
In some aspects, certain components, e.g. the Chlorobutyl-containing components may become sticky after sterilization. According to this aspect, the embodied septum design ensures good separation between components and ease with handling and eventual assembly into the device.
In some aspects of the invention, the septum will contain a terminally recessed portion 12-810, which reduces the piercing force and needle deflection therethrough.
In one aspect, the terminally recessed portion will have a recess ranging from 0.1-5 mm.
In some aspects, the terminally recessed portion will have a recess of about 1 mm from each terminus of the septum. According to this aspect, and in some embodiments, the total septum length is 5 mm, further comprising 2 terminally recessed portions having a recess each of about 1 mm, and in some embodiments, therefore, the piercing length is about 3 mm.
As described herein, it is a further objective of the present invention to provide the prefilled selectively activatable body-worn infusion-pump assembly comprising an aseptically pre-filled drug reservoir, a fluid connection means and a cannula insertion means where the assembly can be fitted to the rest of the infusion-pump components while maintaining sterility and requiring no actions on the part of the end user other than removing the cannula protection cap, adhering the assembled device onto the injection site and pressing a button.
According to this aspect, and in some embodiments, the devices of this invention comprise a single activator part, which is so designed to simultaneously or essentially simultaneously activate 3 steps of depressing a pre-filled drug reservoir to aid in delivery of the drug contained therein, open a fluid path to promote egress and delivery of the drug contained therein and pierce the skin of the user, to promote delivery of the drug contained therein to the user.
The prefilled selectively activatable infusion-pump assembly of this invention may comprise a further level of controlled delivery in the presence of a skin sensor operationally related to the activator, such that without appropriate detection of placement of the device on the skin of the user, the activator button is blocked and initiation of drug delivery from the assembly of the invention is prevented.
In some aspects, and representing embodied elements of the invention, the skin sensor assembly will comprise an optical sensor including a transmitter and receiver, a skin sensor pad with a mechanical barrier (also referred to herein as a “flag”) and a rocker and spring mechanism.
Referring for Example, to
Various configurations and parts for such a regulated engagement are envisioned. A non-limiting example of same may contain components as depicted in
According to this aspect, and in some embodiments, the device further comprises an optical sensor on the PCB assembly, such that when the skin sensor is pressed on the skin of a subject, e.g. via the surface of contact with the patient's skin 13-67, the opto block feature is positioned such that the signal to the optical sensor on the PCB assembly is blocked, and thus, the remainder of events for initiating the device can proceed, since there has been proper indication that the pump is appropriately positioned on the body.
Upon disengagement of the skin sensor, the mechanical flag is rotated/removed, e.g. via the skin sensor pad axis of rotation 13-935 and this in turn prevents further delivery from the device.
Referring to
In some aspects, prior to device activation, the skin sensor pad is in the “down” position, which is facilitated by force applied via spring 13-945 to the proximal end 13-835 of the rocker which pushes the proximal end of the rocker upward. In this orientation, the sensor relay system 13-955 is not obscured by the opto-block region 13-950 of the skin sensor.
According to this aspect, and referring now to
Referring to
It will be appreciated that further regulation of this detachment phenomenon can be readily accomplished, for example, via SW algorithm that determines that the removal is intentional, for example after delivery ends and the user want to remove the device or if the pump has been detached unintentionally or due to malfunction, which, in turn may activate the sounding of an alarm or other warning notice in the device.
The activator may contain further adaptations, such as locking mechanisms 14-850, which facilitate appropriate positioning and placement within the device. For example, and referring to
In some aspects the activator may contain further adaptations, such as sliding guides 14-840, which promote proper propulsion/depression of the activator button so that interfacing parts on the activator located internally to the device are properly engaged. For example, and referring to
In some aspects, the activator switch may contain further adaptations, such as, for example, mounting surfaces 13-890, which also facilitate proper positioning of the activator and its interfacing parts within the device.
Coincident with the activation of the electronic switch, as described above, the needle insertion assembly is propelled, which coordinately regulates/ensures opening of the fluid path and activation of the cannulated needle assembly.
In some aspects, the activator adaptations may be so constructed to allow regulation of steps, whereby the needle dispensing mechanism deployment occurs slightly later than the activation of the engine assembly and/or needle insertion assembly. In some embodiments, the activation of the engine assembly and/or needle insertion assembly is essentially instantaneous and other key steps in the drug delivery pathway are coordinately controlled to occur almost instantaneously, but a slight lag in time may occur and same does not interfere with appropriate controlled drug delivery achievable via the devices and methods of this invention.
Such arrangement/assembly provides uniquely the ability to allow for an aseptically pre-filled container to be used with a skin-adhered patch pump, in marked contrast to known similar drug delivery devices currently in use, which require the end user, or an assistant to fill the pump reservoir and program the pump to deliver the appropriate dosage. Consequently, sterility of the drug path cannot be guaranteed as the path and drug solution is manipulated in a non-aseptic environment. Uniquely the subject invention promotes arrival at an economically viable patch-pump device that comprises the pre-filled drug reservoir and the complete sterile drug path in an economical disposable device that requires minimal manipulation by the end user.
In some aspects of the invention, prefilled injectable devices require a sterile drug path maintained during manufacturing, assembly and storage until the user's point of use.
In some aspects, advantages of the devices of this invention include the ability to prepare sterile drug path components such as a drug reservoir container and cannula insertion assembly, sterilized independently (see steps (1) and (2) in
For example, both components may be removed from their sterile barrier packaging inside an aseptic environment. Then, the drug reservoir container may be filled and capped with a septum (see step (3) in
The final assembly process (see for example, steps (5) and (6) of
As will be appreciated by the skilled artisan, it is beneficial to require assembly of a more minimal number of parts in a fully sterile environment, as opposed to needing full assembly of all or most of the components of the device in a fully sterile environment.
In some aspects, the assembly is such so as to ensure that sterility of the drug delivery path is maintained and no subsequent end-user stage assembly is required. In some aspects, the additional components, such as the engine assembly, housing and other parts are so joined so as to ensure that sterility of the drug path components is not compromised.
It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as set forth in the appended claims. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are intended to be encompassed in the scope of the claims.
In the claims articles such as “a,”, “an” and “the” mean one or more than one unless indicated to the contrary or otherwise evident from the context. Claims or descriptions that include “or” or “and/or” between members of a group are considered satisfied if one, more than one, or all of the group members are present in, employed in, or otherwise relevant to a given product or process unless indicated to the contrary or otherwise evident from the context. The invention includes embodiments in which exactly one member of the group is present in, employed in, or otherwise relevant to a given product or process. The invention also includes embodiments in which more than one, or all of the group members are present in, employed in, or otherwise relevant to a given product or process. Furthermore, it is to be understood that the invention provides, in various embodiments, all variations, combinations, and permutations in which one or more limitations, elements, clauses, descriptive terms, etc., from one or more of the listed claims is introduced into another claim dependent on the same base claim unless otherwise indicated or unless it would be evident to one of ordinary skill in the art that a contradiction or inconsistency would arise. Where elements are presented as lists, e.g. in Markush group format or the like, it is to be understood that each subgroup of the elements is also disclosed, and any element(s) can be removed from the group.
It should be understood that, in general, where the invention, or aspects of the invention, is/are referred to as comprising particular elements, features, etc., certain embodiments of the invention or aspects of the invention consist, or consist essentially of, such elements, features, etc. For purposes of simplicity those embodiments have not in every case been specifically set forth in haec verba herein. Certain claims are presented in dependent form for the sake of convenience, but Applicant reserves the right to rewrite any dependent claim in independent format to include the elements or limitations of the independent claim and any other claim(s) on which such claim depends, and such rewritten claim is to be considered equivalent in all respects to the dependent claim in whatever form it is in (either amended or unamended) prior to being rewritten in independent format.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IL2018/050864 | 8/2/2018 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62548458 | Aug 2017 | US |
