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WO2024081580A1 - Dispositif d'administration de médicament de pompe à seringue - Google Patents

Dispositif d'administration de médicament de pompe à seringue Download PDF

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Publication number
WO2024081580A1
WO2024081580A1 PCT/US2023/076355 US2023076355W WO2024081580A1 WO 2024081580 A1 WO2024081580 A1 WO 2024081580A1 US 2023076355 W US2023076355 W US 2023076355W WO 2024081580 A1 WO2024081580 A1 WO 2024081580A1
Authority
WO
WIPO (PCT)
Prior art keywords
reservoir
leadscrew
syringe plunger
infusion pump
ambulatory infusion
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2023/076355
Other languages
English (en)
Inventor
Adam Evard
Edward Ho
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tandem Diabetes Care Inc
Original Assignee
Tandem Diabetes Care Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Tandem Diabetes Care Inc filed Critical Tandem Diabetes Care Inc
Publication of WO2024081580A1 publication Critical patent/WO2024081580A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons

Definitions

  • the present disclosure relates generally to ambulatory infusion pumps and, more particularly, to a user-wearable pump for delivering medicament such as insulin to a patient.
  • insulin injecting pumps developed for administering insulin to patients afflicted with type I, or in some cases, type II diabetes.
  • Some insulin injecting pumps are configured as portable or ambulatory infusion devices can provide continuous subcutaneous insulin injection and/or infusion therapy as an alternative to multiple daily injections of insulin via a syringe or an injector pen.
  • Such ambulatory infusion pumps are worn by the user and may use replaceable cartridges.
  • these pumps may also deliver medicaments other than, or in addition to, insulin, such as glucagon, pramlintide, and the like. Examples of such pumps and various features associated therewith include those disclosed in U.S. Patent Publication Nos. 2013/0324928 and 2013/0053816 and U.S. Patent Nos. 8,287,495; 8,573,027; 8,986,253; and 9,381,297, each of which is incorporated herein by reference in its entirety.
  • User-wearable infusion pumps can employ various different pumping mechanisms for delivering insulin and/or other medicaments from a reservoir to the user.
  • One common pumping mechanism employs a syringe that forces medicament out of the reservoir.
  • a plunger within the reservoir can be driven by a leadscrew interfaced with a motor, such that when the motor is actuated the leadscrew causes the plunger to be advanced within the reservoir to cause medicament to be delivered out of an outlet in the reservoir.
  • Patch pumps generally are small pumps, typically ambulatory, that are carried directly on the skin under the user’s clothing. Many such pumps are situated directly on the infusion site such that no tubing is required to deliver the insulin and/or other medicament to the patient.
  • Other patch pumps can be positioned on the patient’s body with a short length of tubing extending to a nearby infusion site.
  • Some patch pumps can be at least in part disposable, meant to be worn for a period of time such as, e.g., a day or two, and then discarded and replaced by a new patch pump.
  • Other patch pump designs contemplate a disposable component, such as a cartridge that contains medicament, and a reusable or durable component.
  • the disposable and durable components may be joined together by the patient or caregiver in preparation for delivery of the medicament.
  • Many users would like an infusion pump such as a patch pump to be as small as possible in order to be more comfortable and be carried more discreetly on the user’s body.
  • drive mechanisms such syringe mechanisms described above can place constraints on how small a pump such as a patch pump can be made.
  • Pumps utilizing the pump mechanism disclosed herein can have a smaller form factor than existing syringe pumps by configuring the drive mechanism such that the leadscrew that drives the syringe plunger is disposed within the medicament reservoir.
  • an ambulatory infusion pump can include a reservoir configured to contain a medicament and a leadscrew having a threaded exterior surface extending through the reservoir.
  • a syringe plunger can be disposed within the reservoir and have a threaded interior surface interfacing with the threaded exterior surface of the leadscrew such that rotation of the leadscrew causes linear movement of the syringe plunger through the reservoir to cause the medicament to be delivered from the reservoir to a user.
  • an ambulatory infusion pump can include a reservoir configured to contain a medicament and a leadscrew extending through the reservoir.
  • a syringe plunger can be disposed within the reservoir and have an opening through which the leadscrew is extended. Rotation of the leadscrew can cause linear movement of the syringe plunger along the leadscrew through the reservoir to cause the medicament to be delivered from the reservoir to a user
  • FIGS 1A-1B schematically depict a portion of a leadscrew driven infusion pump according to the prior art.
  • FIGS. 2A-2B schematically depict a portion of a user-wearable infusion pump according to the present disclosure.
  • Figures 3A-3C depict a user-wearable infusion pump according to the present disclosure.
  • FIGS 1A-1B schematically depict a portion of a leadscrew driven userwearable infusion pump 10.
  • infusion pump 10 would include a number of additional components, such as, for example, a motor, processor, housing, etc., only the syringe components are depicted for sake of clarity.
  • Pump 10 includes a reservoir 12 configured to contain a medicament with a plunger 14 disposed therein.
  • Plunger 14 is attached to a drive nut 16 that interfaces with a leadscrew 18.
  • the drive nut 16 which is constrained from rotating, is linearly advanced to move the plunger 14 within the reservoir 12 to deliver medicament from the reservoir.
  • Figure 1 A depicts the plunger 14 in the retracted position and Figure IB depicts the plunger 14 in the fully extended position (i.e., the reservoir is empty because all medicament has been delivered).
  • the length of the overall system has two be more than twice the length of the reservoir in order to deliver all of the fluid from the reservoir due to the overlapping and telescoping nature of the components of the system. This constraint provides a significant challenge in miniaturizing pump delivery systems.
  • FIGS. 2A-2B the syringe components of a user-wearable infusion pump according to the present disclosure are schematically depicted.
  • This embodiment solves the aforementioned problem regarding the required length of the system by positioning the leadscrew 108 within the reservoir 102.
  • the leadscrew 108 is directly interfaced with the plunger 104 such that the leadscrew 108 extends through an opening in the plunger 104 with corresponding threads on the exterior of the leadscrew and the interior of the plunger interfacing with one another.
  • the plunger 104 moves along the leadscrew 108 through the reservoir 102 to cause medicament to be delivered.
  • This design therefore removes the drive nut 16 of the prior embodiment and instead provides threading on the plunger 104 that functions similarly to the drive nut 16. Removal of the separate drive nut components and incorporation of the threads onto the plunger enables the leadscrew 108 to be contained within the reservoir to greatly reduced the required length of the drive system. As can be seen in comparing Figures 2A-2B with Figures 1A-1B, this design enables a pump with a significantly smaller footprint to be manufactured.
  • FIGS 3A-3C depict a leadscrew design such as in Figures 2A-2B being employed with a user- wearable infusion pump 100, which may be configured as a disposable patch pump, according to an embodiment.
  • Pump 100 includes a housing 101 containing a reservoir 102 configured to contain a medicament and a leadscrew 108 configured to be rotated by a motor to drive a plunger 104 through the reservoir to deliver the medicament to the user.
  • a portion 109 of leadscrew that interfaces with the motor to enact rotation of the leadscrew is disposed outside of the reservoir 102 within housing 101.
  • the plunger 104 As the plunger 104 advances distally through the reservoir from the proximal starting position of a fully filled reservoir 102 depicted in these figures, the plunger 104 causes medicament from the reservoir to be expelled out of a port 110 near at a distal end of the reservoir opposite from the starting position of the plunger.
  • plunger 104 can be provided with threading 106 to enable the drive nut of typical syringe drive systems to be eliminated. Plunger 104 therefore moves directly along the threads of leadscrew 108 such that the leadscrew can be disposed within the reservoir 102.
  • the rectangular shape of plunger 104 disposed within the matching interior cross-section of the reservoir 102 prevents the plunger 104 from rotating when the leadscrew 108 is rotated, such that rotation of the leadscrew causes linear movement of the plunger 104 through the reservoir 102.
  • a syringe seal 110 can extend around the interface between plunger 104 and reservoir 102 and a thread seal 112 around the interface between plunger 104 and leadscrew 108 to prevent leakage of fluid.
  • pump 100 depicted in Figures 3A-3C pertains to a patch pump having a self-contained reservoir, it should be understood that the same components could be employed in a pump system having a disposable or refillable cartridge containing a reservoir that interfaces with a reusable pump body including the drive mechanism.
  • leadscrew 108 can comprise stainless steel, plastic, or other material that will not contaminate the medicament with which it is in contact with in the reservoir. Additional and/or alternative components of such an infusion pump system can be found in U.S. Patent Publication Nos. 2011/0144586, 2016/0339172 and 2017/0049957, PCT Publication No. WO 2023/129651 and U.S. Patent No. 10,279,106, each of which is incorporated herein by reference.
  • an ambulatory infusion pump can include a reservoir configured to contain a medicament and a leadscrew having a threaded exterior surface extending through the reservoir.
  • a syringe plunger can be disposed within the reservoir and have a threaded interior surface interfacing with the threaded exterior surface of the leadscrew such that rotation of the leadscrew causes linear movement of the syringe plunger through the reservoir to cause the medicament to be delivered from the reservoir to a user.
  • the syringe plunger has an outer perimeter shape generally matching a shape of an inner cross-section of the reservoir.
  • the syringe plunger provides a seal against the inner crosssection of the reservoir to prevent medicament from leaking proximally passed the syringe plunger.
  • the pump further includes a sealing element extending around an interface between the syringe plunger and the inner cross-section of the reservoir.
  • the pump further includes a sealing element disposed around an interface between the leadscrew and the syringe plunger.
  • the pump further includes a motor configured to cause the leadscrew to rotate.
  • the syringe plunger does not rotate when the leadscrew rotates.
  • a portion of the leadscrew that interfaces with the motor is disposed outside of the reservoir.
  • the leadscrew is formed of a material that will not contaminate the medicament.
  • the pump further includes an outlet port at a distal end of the reservoir, and wherein the syringe plunger causes medicament to be expelled out of the outlet port as the syringe plunger is advanced distally along the leadscrew.
  • an ambulatory infusion pump can include a reservoir configured to contain a medicament and a leadscrew extending through the reservoir.
  • a syringe plunger can be disposed within the reservoir and have an opening through which the leadscrew is extended. Rotation of the leadscrew can cause linear movement of the syringe plunger along the leadscrew through the reservoir to cause the medicament to be delivered from the reservoir to a user.
  • the syringe plunger has an outer perimeter shape generally matching a shape of an inner cross-section of the reservoir.
  • the syringe plunger provides a seal against the inner crosssection of the reservoir to prevent medicament from leaking proximally passed the syringe plunger.
  • the pump further includes a sealing element extending around an interface between the syringe plunger and the inner cross-section of the reservoir.
  • the pump further includes a sealing element disposed around an interface between the leadscrew and the syringe plunger.
  • the pump further includes a motor configured to cause the leadscrew to rotate. In some embodiments, the syringe plunger does not rotate when the leadscrew rotates.
  • a portion of the leadscrew that interfaces with the motor is disposed outside of the reservoir.
  • the leadscrew is formed of a material that will not contaminate the medicament.
  • the further includes an outlet port at a distal end of the reservoir, and the syringe plunger causes medicament to be expelled out of the outlet port as the syringe plunger is advanced distally along the leadscrew.
  • inventions described herein may be discussed in the context of the controlled delivery of insulin, delivery of other medicaments, singly or in combination with one another or with insulin, including, for example, glucagon, pramlintide, etc., as well as other applications are also contemplated.
  • Device and method embodiments discussed herein may be used for pain medication, chemotherapy, iron chelation, immunoglobulin treatment, dextrose or saline IV delivery, treatment of various conditions including, e.g., pulmonary hypertension, or any other suitable indication or application.
  • Non-medical applications are also contemplated.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dermatology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne des appareils et des procédés se rapportant à des pompes à perfusion ambulatoires ayant un mécanisme de pompage de seringue. Les pompes utilisant le mécanisme de pompe selon l'invention peuvent avoir un facteur de forme plus petit que les pompes à seringue existantes en configurant le mécanisme d'entraînement de telle sorte que la vis mère qui entraîne le piston de seringue est disposée à l'intérieur du réservoir de médicament.
PCT/US2023/076355 2022-10-10 2023-10-09 Dispositif d'administration de médicament de pompe à seringue Ceased WO2024081580A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263414689P 2022-10-10 2022-10-10
US63/414,689 2022-10-10

Publications (1)

Publication Number Publication Date
WO2024081580A1 true WO2024081580A1 (fr) 2024-04-18

Family

ID=90670127

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2023/076355 Ceased WO2024081580A1 (fr) 2022-10-10 2023-10-09 Dispositif d'administration de médicament de pompe à seringue

Country Status (1)

Country Link
WO (1) WO2024081580A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030055380A1 (en) * 2001-09-19 2003-03-20 Flaherty J. Christopher Plunger for patient infusion device
US20040153032A1 (en) * 2002-04-23 2004-08-05 Garribotto John T. Dispenser for patient infusion device
US20080051711A1 (en) * 2006-08-23 2008-02-28 Medtronic Minimed, Inc. Infusion medium delivery device and method with drive device for driving plunger in reservoir
KR20200080336A (ko) * 2017-07-07 2020-07-06 뉴로덤 엘티디 유체 약물의 피하 전달용 장치
JP2022009811A (ja) * 2010-09-24 2022-01-14 メドトロニック ミニメド インコーポレイテッド 注入ポンプ
US20220133993A1 (en) * 2017-07-04 2022-05-05 Medtronic Minimed, Inc. Ambulatory infusion pumps and assemblies for use with same

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030055380A1 (en) * 2001-09-19 2003-03-20 Flaherty J. Christopher Plunger for patient infusion device
US20040153032A1 (en) * 2002-04-23 2004-08-05 Garribotto John T. Dispenser for patient infusion device
US20080051711A1 (en) * 2006-08-23 2008-02-28 Medtronic Minimed, Inc. Infusion medium delivery device and method with drive device for driving plunger in reservoir
JP2022009811A (ja) * 2010-09-24 2022-01-14 メドトロニック ミニメド インコーポレイテッド 注入ポンプ
US20220133993A1 (en) * 2017-07-04 2022-05-05 Medtronic Minimed, Inc. Ambulatory infusion pumps and assemblies for use with same
KR20200080336A (ko) * 2017-07-07 2020-07-06 뉴로덤 엘티디 유체 약물의 피하 전달용 장치

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