For wearable medical devices, physical size is a major driver of the overall impact of therapy on the patients employing them. One of the largest elements in a complex and space-constrained medical device (such as an insulin pump) is the reservoir and plunger arrangement. To maintain a small device footprint, a design objective is to optimize the volume occupied by the reservoir and plunger of a drug delivery device.
Using a screw to drive a plunger is advantageous for accurate dispensing from a reservoir. When the screw is in line with the plunger, it effectively doubles the length of the plunger making the packaging/overall size larger. Putting the screw inside of the reservoir is challenging because sealing on the threads of the plunger in addition to the O-ring on the plunger side wall is challenging both technically and for manufacturing. It would be helpful to have a small, low-cost, micro-actuator with reciprocal motion, maximum output force output for a given electrical input.
This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter.
According to an example of the disclosed subject matter, a reservoir for a drug delivery system is disclosed. The reservoir may include a cylindrical housing, a plunger, an elastic sleeve, a lead screw and a reservoir cap. The plunger may be configured to fit within the cylindrical housing. The elastic sleeve may be within the cylindrical housing and be coupled to a surface of the plunger. The elastic sleeve is leakproof. The lead screw may pass through a center of the elastic sleeve and a center of the plunger. The reservoir cap may be coupled to the cylindrical housing.
According to an example of the disclosed subject matter, another reservoir for a drug delivery system is disclosed. The reservoir may include a rigid housing, a plunger, a lead screw and an elastic sleeve. The rigid housing may have a first end and a second end. The plunger may be configured to fit within the rigid housing. The leadscrew may be coupled to the plunger. The elastic sleeve may surround the leadscrew and be coupled to a surface of the plunger and to a surface of the second end of the rigid housing. The elastic sleeve is leakproof.
The following discussion provides a detailed discussion of a drug delivery device reservoir. The reservoir examples described herein may include various features related to an elastic sleeve used to enable a lead screw to pass through an interior of the reservoir.
The housing 120 may be a rigid housing or structure with a first end and a second end. For example, the housing 120 may be in the shape of a cylinder (i.e., a cylindrical housing) with a first end 123 and a reservoir cap 125, where the reservoir cap 125 is the second end. The cylindrical shape of the housing 120 is not limited to a circular cylinder, but may be oval, rectangular, hexagonal or any other tubular shape. The first end 123 of the housing 120 is opposite the reservoir cap 125 (or second end). The reservoir cap 125 may be coupled to the housing 120 or may be integral to the housing 120. For example, the reservoir cap 125 may be coupled to an end of the housing 120 by bonding, welding, friction, snaps (e.g., snap fittings), threads or the like. The reservoir cap 125 is stationary with respect to the housing 120.
The plunger 130 is configured to fit within the housing 120. The plunger 130 includes a fluid stop perimeter 133. The fluid stop perimeter 133 may have a plunger seal 136. For example, the fluid stop perimeter 133 may be a detent or the like in the perimeter of the plunger 130. The shape of fluid stop perimeter 133 may be a semi-circular channel, an arched channel, a square channel or a channel of any shape. The fluid stop perimeter 133 may be filled or occupied by, in place about the plunger 130. The plunger seal 136 may be a leakproof sealing component that contacts the interior of the housing 120. For example, the plunger seal 136 may be an O-ring or similar sealing device. In addition to occupying the fluid stop perimeter 133, the plunger seal 136, which is an example of the leakproof sealing component, is configured to engage an internal wall of the housing 120. In order to effectively function as a leakproof sealing component, the plunger seal 136 is configured to engage the entire internal wall of the housing 120.
The elastic sleeve 110 may be configured as a tube with two open ends. For example, the elastic sleeve 110 may be positioned within the housing 120 and have a first tube end coupled to the reservoir cap 136 and a second tube end, opposite the first tube end, coupled to a surface of the plunger 130. The elastic sleeve 110 is made from a leakproof material, such as, for example, a silicone rubber, flexible polyvinyl chloride (PVC) tubing, or a similar elastic or flexible material and may have an approximate wall thickness of the elastic sleeve 110 may be approximately ½ to ¼ millimeters or the like. The material and the wall thickness of the elastic sleeve 110 may be selected so that the elastic sleeve 110 may fold over on itself as the drug is pushed out. As a result, there is very little hold-up volume of the liquid drug due to the thin walls of elastic sleeve 110. Hold-up volume may be considered an amount of liquid drug that remains after the plunger 130 is no longer able to expel the liquid drug from the reservoir 110.
The lead screw 140 is configured to pass through a center of the elastic sleeve 110 and a center of the plunger 130. The lead screw 140 may have threads, such as lead screw threads 142. The number of threads 142 enables precision movement of the plunger 130 and precise control of an amount of liquid drug that is expelled from the reservoir 100. The lead screw 140 is operable to move the plunger within the housing 120 via engagement of the lead screw 140 with a drive mechanism coupling 175. The drive mechanism coupling 175 may be a link or connection that is operable to transfer forces generated by a drive mechanism to the lead screw 140 in response to which lead screw 140 rotates.
In the illustrated example, the lead screw 140 may also be coupled to a base washer 145. In an example, the base washer 145 is configured with a hole so the lead screw 140 may pass through. The hole in the base washer 145 may be threaded to match the lead screw threads 142. When threaded, the base washer 145 is operable to apply pressure to the plunger 130 or relieve pressure depending upon the direction of rotation of the lead screw 140.
The liquid drug has to flow into and out of the reservoir 100.
While the base washer 145 and the plunger 130 are called out separately, the two elements may be formed as a single component. When the base washer 145 and the plunger 130 are formed as a single component (i.e., base washer/plunger), the elastic sleeve 110 may extend to a top portion of the base washer/plunger (closest to the first end 123).
When the reservoir 100 is starting to be filled, the elastic sleeve 110 is operable to expand as the plunger 130 is moved away in the plunger direction 101 (as well as movement of the base washer 145 in the same direction as the plunger direction 101) from the reservoir cap 136. The movement of the plunger 130 in direction 101 is in response to rotation of the lead screw 140 in a direction away from the reservoir cap 125. In one or more examples, the reservoir 100 may be filled with a liquid drug 188 via the inlet port 161.
The detailed view 101 shows the elastic sleeve 110, a portion of the housing 120, the reservoir cap 125, the plunger 130, the liquid drug 188, and different fluid stop/seal locations A-E. As shown in more detail in
One or more areas for potential leakage in the reservoir 100 may be sealed by different methods at the respective fluid stop/seal locations A-E. Note that the elastic sleeve 110, housing 120, plunger 130 and plunger seal 136, and the reservoir cap 125 are all cylindrical so the left and right sides of
In the example of
The elastic sleeve 110 may have an exterior portion that contacts the liquid drug 188 and an interior portion through which the lead screw 140 may pass. The elastic sleeve 110 maintains a boundary between the liquid drug 188 and the leadscrew 140 in the reservoir 100 since the elastic sleeve 110 is leakproof so too is the boundary. The lead screw 140 may have a threaded zone along the length (i.e., from the first end 123 of the housing 120 to the reservoir cap 125) of the lead screw 140 and the threaded zone is outside of any fluid zone (i.e., the cross-hatched areas where the liquid drug 188 is located). When the liquid drug is to be expelled from the reservoir 100, the elastic sleeve 110 is operable to contract as the base washer 145 and the plunger 130 are moved toward the reservoir cap 136. Since the lead screw 140 passes through the elastic sleeve 110, the lead screw 140 may contact the interior portion of the elastic sleeve 110. The interior portion (i.e., the portion of the elastic sleeve 110 closest to the lead screw 140) of the elastic sleeve 110 may have a lubricant, such as silicone grease or the like. In an example, the elastic sleeve 100 surrounds the leadscrew 140 and may be coupled to a surface (e.g., a top surface closest to the base washer 145) of the plunger 130 and to a surface of the second end (e.g., the reservoir cap 125) of the rigid housing 120.
In the examples 1A-1E, the elastic sleeve 110 may be configured in such a manner that a force is needed to cause the elastic sleeve 100 to expand. The force may be applied by the liquid drug 188 flowing into the reservoir 100, by the plunger 130 and base washer 145 pulling the elastic sleeve 100 away from the reservoir cap 125 in response to a rotation of the lead screw 140, or by a combination of both the liquid drug flowing into the reservoir 100 and the pulling by the plunger 130 and base washer 145. Conversely, because the elastic sleeve 110 was elastic, little or no force is required to be applied by an external source to contract the elastic sleeve 110 back. Only the threads on the threaded base washer 145 described above enable the elastic sleeve 110 to maintain its expanded state. Without the threaded base washer 145 being there, the elastic sleeve 110 would apply pressure to liquid drug 188 and may cause the liquid drug 188 to leak from the reservoir 100.
While threading the base washer and/or the plunger may provide a solution to prevent drainage after filling, other mechanisms and/or techniques are envisioned to lock the base washer 145 and/or plunger in place and prevent the elastic sleeve 100 from contracting, which prevents leakage from the reservoir.
The plunger seals 236 and the elastic sleeve 210 seal a portion of the reservoir 220 between the plunger 230 and the reservoir cap 225. The reservoir 220 is shown with an open top that allows the base washer lock 247, which may be a threaded nut, to be accessed (as shown by the pair of arrows). The open top of the reservoir 220 allows for several options to lock or otherwise engage the base washer lock 247 once filling of the reservoir 220 with the liquid drug 288 is completed. The base washer lock 247 performs two functions: 1) it permits the plunger 230 and base washer 245 to rise freely in the direction away from the reservoir 225 along the length of the lead screw 240 when the reservoir 220 is being filled with a liquid drug 288, and 2) enables more precise control of the amount of liquid drug 288 being dispensed by locking to the lead screw 240 due to the lead screw 240 having to drive the base washer 247 downward toward the reservoir cap 225.
In an example of when the base washer 247 is a threaded nut, the threads may engage threads of the lead screw 240. The lead screw 240 may be operable to move the threaded nut enabling the elastic sleeve 210 to expand and be filled with a liquid drug via the inlet port or to contract and expel the liquid drug from the elastic sleeve 210.
In
Arrow 335 points to a top view of base washer 345. In this example, base washer 345 is circular with a center hole 351 through which may pass the lead screw 340. However, the base washer 345 may also be elliptical with a hole that permits the lead screw 340 to pass. The base washer 345 may further include a first ratchet device 352 and a second ratchet device 354. The first ratchet device 352 and the second ratchet device 354 may be built into, molded into, 3D printed, or otherwise fabricated, while the base washer 345 is fabricated.
The first ratchet device 352 and the second ratchet device 354 may be one-way ratchet features that may be engaged only when the reservoir 300 is filled with the liquid drug and may be configured to permit the base washer 345 to move toward the reservoir cap (shown in previous examples) when expelling the liquid drug from the filled reservoir 300.
The base washer 445 is similar to the base washers of the examples of
The locking assembly 450 includes threaded locking arms 455A, 455B, a spring 458, and a pawl 457. The threaded locking arms 455A and 455B include edges that, when in contact with the keyed lead screw 440, prevent the base washer 445 from moving upwards or downwards on the keyed lead screw 440. The threaded locking arms 455A and 455B may couple respectively to the pivot points 447A and 447B.
In the unlocked state of
While in the unlocked position of
Mechanisms and techniques for maintaining position of the plunger and base washer other than a combination of the keyed cam 446, pawl 457 or threaded locking arms 455A and 455B are envisioned and other examples are described in U.S. Provisional Application No. 63/375,986, filed on Sep. 16, 2022, the entire content of which is incorporated by reference herein.
The wearable drug delivery device 500 may include control circuitry 510, a power supply 520, a drive mechanism 540, a drive mechanism coupling 543, and a reservoir 550. The wearable drug delivery device 500 may be a wearable device that is worn on the body of the user. The wearable drug delivery device 500 may be directly coupled to a user (i.e., directly attached to a body part and/or skin of the user via an adhesive, or the like). In an example, a surface of the wearable drug delivery device 500 may include an adhesive to facilitate attachment to the skin of a user.
The reservoir 550, such as those described herein, may store a liquid drug. In addition, while the device 500 is described with reference to delivery of insulin and the use of an AID algorithm, the device 500 may be operable to implement a drug delivery regimen via a medication delivery algorithm using a number of different liquid or therapeutic drugs. Examples of a liquid drug may be or include any drug in liquid form capable of being administered by a drug delivery device via a subcutaneous cannula, including, for example, insulin, glucagon-like peptide-1 (GLP-1), pramlintide, glucagon, co-formulations of two or more of GLP-1, pramlintide, and insulin; as well as pain relief drugs, such as opioids or narcotics (e.g., morphine, or the like), methadone, arthritis drugs, hormones, such as estrogen and testosterone, blood pressure medicines, chemotherapy drugs, fertility drugs, or the like.
The drive mechanism 540 may be responsive to signals from the control circuitry and may include a number of mechanical elements such as gears, gear trains and the like. The drive mechanism 540 may be operable to drive a lead screw such as those described in earlier examples.
A drive mechanism coupling 543 may couple the drive mechanism 540 to the lead screw and to the reservoir 550. The drive mechanism coupling 543 may translate linear motion into rotary motion, or the like. The drive mechanism coupling 543 may have the structural elements that enable a precise amount of a liquid drug stored in the reservoir 550 to be expelled from the reservoir 550 via a fluid pathway 560 from the wearable drug delivery device 500.
The power supply 520 may be an electrical power source, such as a battery, a super capacitor, an energy harvesting circuit or the like. The power supply 520 may be configured to last several hours, several days or the like. The power supply 520 may be replaceable and/or rechargeable via wired connections or wireless connections.
The wearable drug delivery device 500 may include control circuitry 510 that may be implemented in hardware, software, or any combination thereof. The control circuitry 510 may, for example, be a microprocessor, a logic circuit, a field programmable gate array (FPGA), an application specific integrated circuit (ASIC) or a microprocessor coupled to a memory. The control circuitry 510 may be operable to perform a number of functions, such as executing a control application stored in the memory (not shown) to enable the functions described herein, such as rotation of the lead screw within the reservoir 550.
A type of medication delivery algorithm (MDA) may include an “artificial pancreas” algorithm-based system, or more generally, an artificial pancreas (AP) application. For ease of discussion, the computer programs and computer applications that implement the medication delivery algorithms or applications may be referred to herein as an “AP application.” An AP application may be configured to provide automatic delivery of insulin based on an analyte sensor input, such as signals received from an analyte sensor, such as a continuous blood glucose monitor, ketone sensor, or the like. The signals from the analyte sensor may contain blood glucose measurement values, timestamps, or the like.
Certain examples of the present disclosure were described above. It is, however, expressly noted that the present disclosure is not limited to those examples, but rather the intention is that additions and modifications to what was expressly described herein are also included within the scope of the disclosed examples. Moreover, it is to be understood that the features of the various examples described herein were not mutually exclusive and may exist in various combinations and permutations, even if such combinations or permutations were not made express herein, without departing from the spirit and scope of the disclosed examples. In fact, variations, modifications, and other implementations of what was described herein will occur to those of ordinary skill in the art without departing from the spirit and the scope of the disclosed examples. As such, the disclosed examples are not to be defined only by the preceding illustrative description.
It is emphasized that the Abstract of the Disclosure is provided to allow a reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, various features are grouped together in a single example for streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed examples require more features than are expressly recited in each claim. Rather, as the following claims reflect, novel subject matter lies in less than all features of a single disclosed example. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate example. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein,” respectively. Moreover, the terms “first” and “second” are used merely as labels and are not intended to impose numerical requirements on their objects.
The foregoing description of examples has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the present disclosure to the precise forms disclosed. Many modifications and variations are possible considering this disclosure. It is intended that the scope of the present disclosure be limited not by this detailed description, but rather by the claims appended hereto. Future filed applications claiming priority to this application may claim the disclosed subject matter in a different manner and may generally include any set of one or more features as variously disclosed or otherwise demonstrated herein.
This application claims priority to and the benefit of U.S. Provisional App. No. 63/386,249, filed Dec. 6, 2022, the entirety of which is incorporated by reference herein.
Number | Date | Country | |
---|---|---|---|
63386249 | Dec 2022 | US |