[go: up one dir, main page]

WO2025122410A1 - Tube de trajet de fluide - Google Patents

Tube de trajet de fluide Download PDF

Info

Publication number
WO2025122410A1
WO2025122410A1 PCT/US2024/058031 US2024058031W WO2025122410A1 WO 2025122410 A1 WO2025122410 A1 WO 2025122410A1 US 2024058031 W US2024058031 W US 2024058031W WO 2025122410 A1 WO2025122410 A1 WO 2025122410A1
Authority
WO
WIPO (PCT)
Prior art keywords
tubing
section
connector
tubing assembly
inner diameter
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.)
Pending
Application number
PCT/US2024/058031
Other languages
English (en)
Inventor
Mukund P. PATANKAR
Steven Carl Persak
Liem Nguyen
Guangli Hu
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.)
Merck Sharp and Dohme LLC
Original Assignee
Merck Sharp and Dohme LLC
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 Merck Sharp and Dohme LLC filed Critical Merck Sharp and Dohme LLC
Publication of WO2025122410A1 publication Critical patent/WO2025122410A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/08—Tubes; Storage means specially adapted therefor
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • 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
    • 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

Definitions

  • such devices are commonly used to infuse a basal rate of insulin to subjects suffering from diabetes, as an alternative to insulin injections by an insulin syringe or an insulin pen.
  • the pump is adhered to the abdomen of the patient and delivers the substance to the patient via a cannula that is inserted into the patient's skin.
  • Traditional pumps or injectors are limited.
  • the injection forces of traditional injectors may be suboptimal or injection time may be too long. This may be particularly an issue with highly viscous substances.
  • a tubing assembly for an injection device includes a tubing having a first end and a second end, the tubing defining a lumen from the first end to the second end, the tubing having a first terminal portion, a first tapered portion, a central portion, a second tapered portion, and a second terminal portion.
  • a tubing assembly for an injection device includes a tubing having a first end and a second end, the tubing defining a lumen having a constant inner diameter and a constant outer diameter from the first end to the second end, a first connector coupled to the first end, the first connector having a first enlarged section, a first tapered section and a first narrowed section, and a second connector coupled to the second end, the second connector having a second enlarged section, a second tapered section, and a second narrowed section.
  • FIG.1A-1B are a schematic representation and a photograph of a common tubing assembly used with an apparatus for administering a substance to a subject
  • FIG.1C is a schematic representation of a tubing assembly according to a first embodiment
  • FIG.2 is a chart showing potential dimensions for components of an apparatus for administering a substance to a subject including a tubing assembly according to the first embodiment
  • FIGS.3-4 are photographs and schematic representations of a tubing assembly according to another embodiment.
  • FIG.5 is a chart showing potential dimensions for a tubing assembly according to another embodiment
  • FIGS.6, 7A, and 7B are schematic representations of a tubing assembly having connectors according to another embodiment
  • FIG.7C is a photograph of a tubing assembly having connectors being coupled to cannulas according to one embodiment
  • FIG.8 is a photograph of a testing assembling to perform experiments on the tubing assembly
  • FIG.9 is a graph showing results of the experiments performed by the testing assembly of FIG.8.
  • proximal when used in connection with a component of an injector, refers to the end of the component closest to the injector; whereas the term “distal,” when used in connection with a component of an injector, refers to the end of the component closest to the needle insertion site during use.
  • distal when used in connection with a component of an injector, refers to the end of the component closest to the needle insertion site during use.
  • the terms “trailing” and “leading” are to be taken as relative to the operator’s fingers (e.g., physician) of the injector. “Trailing” is to be understood as relatively close to the operator’s fingers, and “leading” is to be understood as relatively farther away from the operator’s fingers.
  • the terms “medicament,” “medication,” and “drug” are used generically interchangeably and it will be understood that the ampoules described herein may be used to store, deliver or administer vaccines, biologics, therapeutic, medicaments, topical ointments, and the like.
  • Certain terminology is used in the following description for convenience only and is not limiting.
  • the words “right,” “left,” “lower” and “upper” designate directions in the drawings to which reference is made.
  • the words “inwardly” and “outwardly” refer to directions toward and away from, respectively, the geometric center of the device and designated parts thereof.
  • FIGS. 1A-1B show an example of a tubing assembly 1000 that includes a cartridge needle hub 1020a that terminates in a cartridge needle or cartridge cannula 1022a for piercing a medicament container or vial V1, and a patient needle hub 1020b that terminates in a patient needle or patient cannula 1022b.
  • a hollow tubing 1010 extends between cartridge needle hub 1020a and patient 25879 needle hub 1020b and connects the two components to create a fluid path P1 from cartridge cannula 1022a to patient cannula 1022b as shown in FIG.1A.
  • the pressure drop in a fluid pipe or tubing assembly may be governed by the Hagen Poiseuille equation show below: where ⁇ is L is Length of the pipe, Q is Volumetric Flow rate, R is Radius of the pipe (or , Pressure difference between two ends. It will be appreciated from this equation that radius has the highest impact on pressure drop and that increasing the radius of the tubing may substantially reduce pressure drop.
  • total pressure drop in the fluid path may be calculated as: where Pc to the cartridge cannula, and Tu refers to the tubing connecting both cannulas. From this equation, it is apparent that several options are available to reduce the pressure drop and the corresponding injection force. For example, modifying one or more of the cannulas may achieve certain gains, but involves changing multiple parts and complex capital equipment. Alternatively, increasing the tubing diameter may have a large impact on the pressure drop. Specifically, the tubing may be modified without altering the remaining structure of the tubing assembly (e.g., with modifying the cannulas).
  • tubing 1100 may be provided that has a central portion 1110, two tapered portions 1115a,1115b and two terminal portions 1116a,1116b, with a continuous lumen L1 extending between terminal portions 1116a,1116b.
  • tubing 1100 maybe between 40 mm and 65 mm (e.g., between 50 mm and 60 mm, or approximately 56 mm) in length from the end of terminal portion 1116a to the end of terminal portion 1116b.
  • Tubing 1100 may be configured in a such way that it has a larger diameter at central portion 1110 and smaller diameters at the terminal portions 1116a,1116b.
  • central portion 1110 has an inner diameter of approximately 0.5 mm.
  • terminal portions 1116a,1116b have the same inner diameter of approximately 0.29 mm. It will be understood that the terminal portions 1116a,1116b may instead have unequal inner diameters, if desired.
  • the tapered portions 1115a,1115b may transition the tubing 1100 from the relatively larger inner diameter at central portion 1110 to the relatively smaller diameter at terminal portions 1116a,1116b. In at least some examples, tapered portions 1115a,1115b may be between 2 mm and 8 mm in length, and may transition the inner diameter (i.e., the diameter of the lumen) from 0.5 mm to 0.29 mm.
  • tubing 1100 may be formed using molding techniques, such as dip molding. Specialized extrusion techniques, such as bump extrusion techniques, may also be used. In some examples, tubing 1100 may be formed of one or more materials, including various polymers or thermoplastic elastomers (TPE).
  • TPE thermoplastic elastomers
  • FIG.2 is a chart showing certain dimensions of components of an exemplary injector system that include a cartridge, plunger, cartridge needle, patient needle, and proposed tubing dimensions in the last two rows.
  • tubing 1200 may be extruded and a secondary operation may be performed to create a shape that has a gradually increasing inner diameter between two sections following by a gradually decreasing inner diameter.
  • tubing 1200 may be divided into three portions at locations 12-1, 12-2 and 12-3, and the tubing 1200 may be connected to a cartridge needle hub 1220a that terminates in a cartridge needle or cartridge cannula 1222a, and a patient needle hub 1220b that terminates in a patient needle or patient cannula 1222b.
  • FIG.5 is a chart showing certain dimensions of examples of such a tubing. As shown, it may be difficult to achieve consistent dimensions (e.g., tapering) using this secondary operation. Without being bound to any particular theory, it is believed that initial testing reveals that the use a varying-diameter tube reduced the injection force by 25%.
  • tubing assembly 1600 including a large diameter tubing 1610 having a constant inner diameter from one end to the other.
  • the inner diameter of tubing 1610 may be similar to the central portions described above for other embodiments (e.g., between 0.4 mm and 0.6 mm, or about 0.5 mm) and the outer diameter may be between 1.6 mm and 2.0 mm, or about 1.74 mm.
  • Two molded connectors 1620 may be coupled to opposing ends of tubing 1610 and configured to receive ends of the tubing. In some examples, molded connectors 1620 may be friction fit onto tubing 1610, although other coupling means are possible.
  • each connector 1620 may include an enlarged section 1622, a tapered section 1624 and a narrowed section 1626.
  • Enlarged section 1622 may have a first inner diameter, D1, configured to receive the outer diameter of tubing 1610 (e.g., enlarged section 1622 may define an inner diameter of approximately 1.8 mm).
  • Tapered section 1624 may have a series of gradually decreasing inner diameters D2 that reduce the inner diameter to an inner diameter D3 of narrowed section of approximately 0.28 mm.
  • inner diameters D2 in the tapered section begin with an inner diameter of 1.8 mm and linearly decrease to an inner diameter for 0.28 mm. Non-linear transitions are also possible in the tapered sections.
  • Connectors 1620 may be coupled to ends of tubing 1610 and a cannula may be disposed within the narrowed section 1626 of each connector, one to the patient and another to the vial. Without being bound to any particular theory, it is believed that initial testing reveals that the use of connectors in this manner reduced the injection force by approximately 40%.
  • FIG.8 shows a system for empirically testing the various tubing assemblies. In this example, various tubings were tested at a constant rate on an INSTRON® machine and the force output was measured utilizing BLEF test setup.
  • the test speed was 4.5 mm/min or equivalent to 1.2 mL/minute
  • the test fluid was N10 (mineral oil) with a viscosity of ⁇ 19cP at 20 degrees Celsius. Cartridges were filled to 5 mL.
  • the test fluid was N10 with a viscosity of approximately 19 cP, substances contemplated for use with tubing according to the present disclosure may vary.
  • substances to be used with the present disclosure may have a viscosity of 0-5 cP, 5-10 cP, 10-15 cP, 15-20 cP, 20-25 cP, 25-30 cP, 30- 35 cP, 35-40 cP, 40-45 cP, 45-50 cP, 50-55 cP, 55-60 cP, 60-65 cP, 65-70 cP, 70-75 cP, 75-80 cP, or 80-90 cP, 90-100 cP, or 100 cP or more.
  • These substances may be administered at 15-20 degrees C, 20-25 degrees C, or 25 or more degrees C.
  • FIG.9 illustrates results according to the tested protocol.
  • Curve 1900 represents the baseline tubing having a constant diameter, which shows a measured force between 90N and 100N.
  • Curve 1910 represents the first embodiment in which a tubing is manufactured to include varying diameters according to the embodiments described with respect to FIGS.1C-5, and it shows a decrease in the force of approximately 25%.
  • Curve 1920 represents the second embodiment in which a tubing is used in conjunction with molded connectors according to the embodiments described with respect to FIGS.6-7C, and a decrease in the force of approximately 40% was observed.

Landscapes

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

Abstract

Dans certains exemples, un ensemble tube pour un dispositif d'injection comprend un tube ayant une première extrémité et une seconde extrémité, le tube définissant une lumière ayant un diamètre interne constant et un diamètre externe constant de la première extrémité à la seconde extrémité, un premier connecteur couplé à la première extrémité, le premier connecteur ayant une première section agrandie, une première section conique et une première section rétrécie, et un second connecteur couplé à la seconde extrémité, le second connecteur ayant une seconde section agrandie, une seconde section conique et une seconde section rétrécie.
PCT/US2024/058031 2023-12-05 2024-12-02 Tube de trajet de fluide Pending WO2025122410A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363606471P 2023-12-05 2023-12-05
US63/606,471 2023-12-05

Publications (1)

Publication Number Publication Date
WO2025122410A1 true WO2025122410A1 (fr) 2025-06-12

Family

ID=95980369

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/058031 Pending WO2025122410A1 (fr) 2023-12-05 2024-12-02 Tube de trajet de fluide

Country Status (1)

Country Link
WO (1) WO2025122410A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3042045A (en) * 1958-07-02 1962-07-03 David S Sheridan Medico-surgical tubes having integral connectors formed in their ends
US20060100511A1 (en) * 2002-10-09 2006-05-11 Morten Eriksen Tube
US20090054875A1 (en) * 2006-02-22 2009-02-26 Strauss Bradley H Guide-wire sleeve for facilitation of lesion crossing
US20140091569A1 (en) * 2012-10-01 2014-04-03 Medrad, Inc. Overmolded medical connector tubing and method
US20190262579A1 (en) * 2015-12-09 2019-08-29 Dentsply Ih Ab Urinary catheter with integrated connector

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3042045A (en) * 1958-07-02 1962-07-03 David S Sheridan Medico-surgical tubes having integral connectors formed in their ends
US20060100511A1 (en) * 2002-10-09 2006-05-11 Morten Eriksen Tube
US20090054875A1 (en) * 2006-02-22 2009-02-26 Strauss Bradley H Guide-wire sleeve for facilitation of lesion crossing
US20140091569A1 (en) * 2012-10-01 2014-04-03 Medrad, Inc. Overmolded medical connector tubing and method
US20190262579A1 (en) * 2015-12-09 2019-08-29 Dentsply Ih Ab Urinary catheter with integrated connector

Similar Documents

Publication Publication Date Title
US11123520B2 (en) Collapse-resistant swellable catheter
AU2011308664B2 (en) Systems and methods for improving catheter hole array efficiency
US5078679A (en) Post-surgical anesthesia at a continuous and progressively decreasing administration rate
AU2012299355B2 (en) A catheter having a pressure activated splittable feature
US20030181863A1 (en) Microneedle adapter
US11779535B2 (en) Succinylcholine prefilled syringe, compositions and methods
WO2025122410A1 (fr) Tube de trajet de fluide
CN107073209B (zh) 用于注射药物的皮下输注设备
WO2025122411A1 (fr) Trajet d'écoulement de fluide pour injecteur
CN211751504U (zh) 一种微型微量免配药输注泵
EP4299089A1 (fr) Ensemble aiguille pour un dispositif d'injection ou de perfusion
US20250367374A1 (en) Integrated coil multi-material extusion for infusion set cannula
US20250367402A1 (en) Systems and methods for manufacturing infusion cannulas
US20250009974A1 (en) Vascular Access Device With Effective Needle Length Adjustment
HK40048812B (zh) 用於注射药物的皮下输注设备

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 24901352

Country of ref document: EP

Kind code of ref document: A1