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WO2025096628A1 - Dispositif d'insertion de cathéter et procédé d'insertion d'un cathéter - Google Patents

Dispositif d'insertion de cathéter et procédé d'insertion d'un cathéter Download PDF

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Publication number
WO2025096628A1
WO2025096628A1 PCT/US2024/053682 US2024053682W WO2025096628A1 WO 2025096628 A1 WO2025096628 A1 WO 2025096628A1 US 2024053682 W US2024053682 W US 2024053682W WO 2025096628 A1 WO2025096628 A1 WO 2025096628A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
channel
septum
button
housing
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/US2024/053682
Other languages
English (en)
Inventor
Nicolas BESSON
Vincent DELOBELLE
Gilles BERNЀDE
Salim Bouyahiaoui
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.)
Becton Dickinson and Co
Original Assignee
Becton Dickinson and Co
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 Becton Dickinson and Co filed Critical Becton Dickinson and Co
Publication of WO2025096628A1 publication Critical patent/WO2025096628A1/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
    • 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
    • A61M5/14244—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
    • A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
    • 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
    • A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
    • A61M2005/14256—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means with means for preventing access to the needle after use
    • 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
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M2005/16863—Occlusion detection
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3114—Filling or refilling
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3561—Range local, e.g. within room or hospital
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated

Definitions

  • the present invention relates generally to medical injection systems, such as a medicament injection device or infusion device or insertion device, where simple, low-profile and low-part count manual insertion device is provided with a retraction spring configuration for automatic introducer needle retraction.
  • the dual retraction spring configuration is implemented using multiple barrel-shaped guides and bosses in the insertion device housing which allows for much smaller retraction springs to be used than in a single-barrel configuration.
  • bolus or infusion set a disposable component
  • tubing set or pump set which conveys the medicament from a reservoir within the pump into the skin of the user.
  • the bolus or infusion set consists of a pump connector, a length of tubing, and a hub or base from which a cannula, in the form of a hollow metal bolus or infusion needle or flexible plastic catheter extends.
  • the base typically has an adhesive that retains the base on the skin surface during use.
  • the cannula can be inserted onto the skin manually or with the aid of a manual or automatic insertion device.
  • the insertion device can be a separate unit required by the user.
  • a patch pump also called a wearable drug delivery device.
  • a patch pump is an integrated device that combines most or all of the fluidic components, including the fluid reservoir, pumping mechanism and mechanism for automatically inserting the cannula, in a single housing which is adhesively attached to a bolus or infusion site on the patient’s skin, and does not require the use of a separate bolus or infusion or tubing set.
  • a patch pump containing medicament adheres to the skin and delivers the medicament over a period of time via an integrated subcutaneous cannula.
  • Some patch pumps can wirelessly communicate with a separate controller device (as in one device sold by Insulet Corporation under the brand name OmniPod®), while others are completely self-contained. Such devices are replaced on a frequent basis, such as every three days, when the medicament reservoir is exhausted or complications can otherwise occur, such as restriction in the cannula or the bolus or infusion site.
  • a separate controller device as in one device sold by Insulet Corporation under the brand name OmniPod®
  • patch pumps are designed to be a self-contained unit that is worn by the patient, it is preferable its dimensions and weight are as small as possible, comfortable to wear so that it does not interfere with the activities of the user. Thus, to minimize discomfort to the user, it would be preferable to minimize the overall thickness of the patch pump. However, to minimize the thickness of the patch pump, its constituent parts should be reduced as much as possible. One such part is the insertion mechanism for automatically inserting the cannula into the user’s skin.
  • Drugs considered for such patch pump application are various and their fluidic properties can vary, especially viscosity which can vary from IcP to 100 cP.
  • viscosity increases, pressure drop in the patch pump fluidic system increases but, because these patch pump devices have to be small, pump pressure capabilities are generally limited.
  • fluid path(s) conducting the drug into the patch pump device have to be adapted to accept high viscosity drugs but with limited pressure into the device so that the pump can transfer all types of fluid.
  • the drop pressure is linked to flow rate that can vary from 5 to 20 ml/min for bolus injection to 0. Iml/hr or below for bolus or infusion. Because an insertion mechanism is part of the fluid path, it has to be configured by taking this pressure problem into account.
  • some conventional insertion mechanisms are configured to insert the cannula at an acute angle from the surface of the skin, e.g. 30-45 degrees.
  • the minimum length of cannula being inserted into the user’s skin, the user can experience greater comfort and fewer complications, such as premature kinking of the cannula.
  • one problem with insertion of the cannula is determining whether the cannula is fully inserted into the surface of the skin.
  • a catheter insertion device comprising: a housing defining a first channel; a septum defining a second channel and an opening extending from the second channel; and a catheter at least partially positioned within the opening of the septum.
  • the septum is movable relative to the housing between a first position and a second position. In the first position, the septum is spaced apart from the first channel of the housing, and in the second position, the septum is positioned adjacent the first channel to align the second channel with the first channel, permitting fluid flow from the first channel to the second channel.
  • a catheter insertion device comprises: a housing including an angled surface; a needle assembly that is movable relative to the housing between a retracted position and an extended position, wherein the needle assembly includes a needle and a needle hub fixedly coupled to the needle, the needle extends out of the housing in the extended position, and the needle is positioned entirely within the housing when the needle assembly is in the retracted position, the needle hub includes a guide, wherein the needle extends along and is movable along an axis; a button movable relative to the housing along the axis between a raised position and a depressed position, the button defining a groove including an engagement portion and a guiding portion, the guiding portion extending at least partially along the axis, and the engagement portion extends obliquely or perpendicularly to the guiding portion to engage the guide of the needle hub and move the needle assembly with the button from the raised position to the depressed position; and a biasing member engaged between the needle
  • the angled surface of the housing contacts the guide of the needle hub when the needle assembly is in the extended position to rotate the needle hub relative to the button and move the guide out of engagement with the engagement portion, and the biasing member biases the needle assembly to move along the guiding portion to the retracted position.
  • FIG. 1 is an isometric view of an example dmg delivery device with an insertion device shown a pre-activation state in accordance with an embodiment of the present invention
  • FIG. 2 is an isometric view of the insertion device of FIG. 1 in a post-activation state in accordance with an embodiment of the present invention
  • FIG. 3 is an exploded view of the insertion device of FIG. 1 in accordance with an embodiment of the present invention
  • FIG. 4 is an isometric view of a button subassembly of the insertion device of FIG. 1 in the pre-activation state, in accordance with an embodiment of the present invention
  • FIG. 5 is a cross-sectional side view of the button subassembly of FIG. 5, in accordance with an embodiment of the present invention
  • FIG. 6 is an isometric view of the button subassembly of FIG. 4 in an intermediate activation state, in accordance with an embodiment of the present invention
  • FIG. 7 is a cross-sectional side view of the button subassembly of FIG. 6, in accordance with an embodiment of the present invention.
  • FIG. 8 is an isometric view of the button subassembly of FIG. 4 in the postactivation state, in accordance with an embodiment of the present invention
  • FIG. 9 is a cross-sectional side view of the button subassembly of FIG. 8, in accordance with an embodiment of the present invention.
  • FIGS. 10A, 10B and 10C are cross-sectional side views of another button subassembly in the pre-activation state (FIG. 10A), the intermediate activation state (FIG. 10B), and the post-activation state (FIG. 10C), in accordance with an embodiment of the present invention
  • FIG. 11 is an isometric view of another button subassembly in the pre-activation state, in accordance with an embodiment of the present invention.
  • FIG. 12 is a cross-sectional side view of the button subassembly of FIG. 11, in accordance with an embodiment of the present invention.
  • FIG. 13 is an exploded view of the button subassembly of FIG. 11, in accordance with an embodiment of the present invention.
  • FIG. 14 is an isometric view of the button subassembly of FIG. 11 in the postactivation state, in accordance with an embodiment of the present invention
  • FIG. 15 is a cross-sectional front view of the button subassembly of FIG. 11 in the intermediate activation state, in accordance with an embodiment of the present invention.
  • FIG. 16 is a cross-sectional side view of the button subassembly of FIG. 11 in the post-activation state, in accordance with an embodiment of the present invention.
  • FIG. 17 is a perspective view of an example patch pump that can incorporate a low- profile cannula insertion device constructed in accordance with an embodiment of the present invention, and that is illustrated without a cover for clarity;
  • FIG. 18 is an exploded view of the various components of the patch pump of FIG. 17, illustrated with a cover;
  • FIG. 19 is a perspective view of an alternative design for a patch pump having a flexible reservoir, illustrated without a cover, that can operate with a low-profile cannula insertion device constructed in accordance with an embodiment of the present invention.
  • FIG. 20 is a patch-pump fluidic architecture and metering sub-system diagram of the patch pump of FIG. 19. DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS
  • the exemplary embodiments of the present invention described below provide novel means of providing one or more bolus or infusion device elements that are configured to insert a catheter into skin of a user to subcutaneously deliver a medicament to a patient, and indicate when the catheter is fully inserted into the skin, but embodiments are not limited thereto.
  • the insertion device is configured to perform a manual insertion of the catheter which allows the insertion device to be smaller, simpler and cheaper than automatic or spring-assisted insertion devices.
  • the insertion device provides an improved catheter insertion mechanism that minimizes fluid resistance during injection to increase flow rate and reduce pressure drop of the medicament during injection of the insertion mechanism.
  • Exemplary embodiments of the present invention described below utilize a manual insertion device and include a dual retraction spring configuration for automatic introducer needle retraction that also allows for a very small device size.
  • the dual retraction spring configuration is implemented using one or more cylindrical or barrel-shaped guides.
  • one barrel guides a button and catheter, and adjacent barrel(s) house retraction springs, where the barrels can be arranged concentrically with the button and catheter guide or positioned on the sides of the button and catheter.
  • a single coaxial spring creates access to the button assembly with the spring extending from the bottom of the housing to the top.
  • the single spring allows for a better integration of parts by reducing the footprint of the design and simplifying the design to reduce the number of parts. Access is required for features like the locking arm and, if the features are implemented inside the spring, the entire mechanism must grow to accommodate them, increasing the mechanism foot print.
  • the top housing 100, the button 124, and the insertion mechanism 12 can be manufactured from ABS, PA, PC, PE, PMMA, PP, PETG and the base 102 can be manufactured from PETG , PA, PC, PE, PMMA, PP, ABS, but embodiments are not limited thereto.
  • the example drug delivery device 10 is assembled with a number of subassemblies which are disposed between the top housing 100 and the base, including the insertion mechanism 12 among other subassemblies.
  • the insertion mechanism 12 shown in FIG. 3 and discussed in greater detail below includes a housing 110, a septum 112, a sheath 114 (FIG. 5), a catheter 116, a needle assembly 118, a biasing member 120, and a button 124, and can be fluidically connected to a pump 122 provided in the drug delivery device 10.
  • the housing 110 can include an outer wall 126, an inner wall 128 positioned within the outer wall 126, a bottom 130 coupled to a lower portion 132 of the outer wall 126, and a cap 134 coupled to an upper portion 136 of the outer wall 126 to partially enclose a cavity 138 within the outer wall 126.
  • Each of the inner wall 128 and the outer wall 126 can circumferentially surround a central axis 140 to each be a hollow cylinder.
  • the inner wall 128 can be configured to enclose components of the catheter insertion device 12, such as, for example, the button 124 and the needle assembly 118, and the outer wall 126 can circumferentially surround the inner wall 128 to define a space for receiving the biasing member 120.
  • the outer wall 126 of the housing 110 can define a groove 142 for guiding a guide 144 of the needle assembly 118, as will be described in greater detail below.
  • the groove 142 can include a guiding portion 146, an engagement portion 148, and a return portion 150.
  • the guiding portion 146 extends in parallel with the central axis 140 to allow the guide 144 of the needle assembly 118 to move toward the bottom 130 of the outer wall 126.
  • the engagement portion 148 is positioned between the guiding portion 146 and the return portion 150, and extends obliquely to the guiding portion 146 and toward the bottom 130.
  • the engagement portion 148 includes an angled surface 152 that is angled obliquely to the guiding portion 146 to rotate the needle assembly 118 through contact with the guide 144 as the needle assembly 118 moves toward the bottom 130.
  • the return portion 150 extends substantially in parallel with the guiding portion 146 and the central axis 140, and extends away from the guiding portion 146 toward the cap 134 to permit the needle assembly 118 to move upward away from the bottom 130 of the outer wall 126.
  • the inner wall 128 can define a plurality of channels 160 extending along a length of the inner wall 128 in parallel with the central axis 140, where the channels 160 are configured to allow the guide 144 of the needle assembly 118 to extend out to the groove 142 of the outer wall 126 and rotate the needle assembly 118 when the guide 144 contacts the engagement portion 148.
  • the inner wall 128 further defines a detent 162 (FIG. 5) for engaging and holding the button 124 in position, as will be described in greater detail herein.
  • the bottom 130 of the outer wall 126 defines an opening 164 shaped to be complementary to a shape of the septum 112 to be configured to receive the septum 112.
  • the bottom 130 can additionally define a first channel 166 that is open at the opening 164 of the bottom 130, where the pump 122 can include a tube 168 attached to the bottom 130 to be in fluidic communication with the first channel 166.
  • the pump 122 can move fluid along the tube 168 to the first channel 166 and to the opening 164 in the bottom 130.
  • the button 124 can include a base 180 configured to be pressed by a user, a pair of arms 182 extending from the base 180 into the housing 110, and a protrusion 184 extending from the arms 182 for engaging the housing 110.
  • the button 124 can define a cavity 186 and an opening 188 extending to the cavity 186 to be configured to house the needle assembly 118.
  • the base 180 can be sized larger than the opening 164 in the cap 134 to prevent the base 180 from passing into the housing 110.
  • the arms 182 are sized to extend from the base 180 into the opening 164 of the cap 134 to be positioned in the inner wall 128 of the housing 110.
  • the protrusion 184 is shaped and positioned to engage the detent 162 in the inner wall 128 of the housing 110 when the button 124 is in a specified position.
  • the arms 182 are spaced apart to permit the guide 144 of the needle assembly 1 18 to extend between the arms 182.
  • the arms 182 extend to the septum 112 to be coupled to the septum 112, and move with the septum 112.
  • the arms 182 define a detent 190, or cutout, that extends into one of the arms 182 from the space between the arms 182, where the detent 190 engages the guide 144 of the needle assembly 118 to move the needle assembly 118 with the button 124 between a raised position and a depressed position.
  • the needle assembly 118 can include a needle 200 and a needle hub 202 fixedly coupled to the needle 200.
  • the needle assembly 118 is movable relative to the button 124 and the septum 112, where the needle 200 can extend entirely through the septum 112, and be retractable relative to the septum 112 to be positioned partially in the septum 112.
  • the needle hub 202 can be positioned within the cavity 186 of the button 124 with the needle 200 at least partially extending out of the cavity 186 through the opening 188 of the button 124.
  • the needle hub 202 can include the guide 144 that extends from the needle hub 202 through the space between the arms 182 of the button 124 to engage the groove 142 in the outer wall 126 of the housing 110.
  • the guide 144 extends between the inner wall 128 and the outer wall 126 to engage the biasing member 120 such that the biasing member 120 is engaged between the needle hub 202 and the housing 110, which biases the needle assembly 118 toward the base 180 of the button 124.
  • the housing 110 can include two grooves 142, with the needle hub 202 including two guides 144 for engaging the grooves 142.
  • the needle assembly 118 include a single guide 144 and the housing 110 include a single groove 142.
  • the guide 144 of the needle hub 202 engages the detent 190 in the button 124 to move with the button 124 between the raised position and the depressed position.
  • the guide 144 of the needle hub 202 engages the groove 142 of the housing 110 to rotate the needle hub 202 about the axis 140 as the needle assembly 118 moves with the button 124 from the retracted position to the extended position, where the guide 144 is rotated out of contact with the detent 190 of the button 124.
  • the biasing member 120 biases the needle assembly 118 toward the base 180 of the button 124 to retract the needle 200 from the septum 112.
  • the septum 112 can act as a fluidic chamber to direct fluid flow, and can include a body 210 with a first portion 212 and a second portion 214 formed as separate components and coupled together, and a membrane 216 positioned within the second portion 214 of the body 210.
  • the first portion 212 of the body 210 can be frustoconical in shape and define a cavity for receiving the second portion 214.
  • the membrane 216 can be positioned within the second portion 214 and be configured to form a seal around the needle 200 of the needle assembly 118 when the needle 200 extends through the membrane 216.
  • the body 210 can define a second channel 218 positioned to interface with the first channel 166 of the housing 110, and a third channel 220 that extends along the central axis 140 through both the first portion 212 and the second portion 214 of the body 210.
  • the second channel 218 can extend to intersect the third channel 220 to be in fluid communication with the third channel 220, where the second channel 218 is configured to transfer fluid from the first channel 166 to the third channel 220.
  • the septum 112 is movable relative to the housing 110 between a first position (FIG. 5) and a second position (FIG 7).
  • the septum 112 In the first position, the septum 112 is spaced apart from the opening 164 in the bottom 130 with the second channel 218 in the septum 112 spaced apart from the first channel 166 in the housing 110. In the second position, the septum 112 is positioned within the opening 164, with the second channel 218 aligned with the first channel 166 to permit fluid flow from the first channel 166 to the second channel 218.
  • the septum 112 When the septum 112 is positioned in the second position within the opening 164, the septum 112 forms a seal with the housing 110 to seal the first channel 166 with the second channel 218, preventing fluid leakage between the septum 112 and the housing 110.
  • the septum 112 can include seals, such as O-ring seals, positioned around the first portion 212 and the second portion 214 to seal the channels 166, 218, 220. Referring to FIGS.
  • the third seal 226 can be similar in structure to the first and second seals 222, 224, such as an O-ring, or can alternatively be an adhesive, such as glue, that seals and couples together the first portion 212 and the second portion 214 of the septum 112.
  • the septum 112 can include slits or ridges defined around a circumference of the septum 112 to permit the seals to be positioned therein, thereby aligning the seals to restrict the seals from moving relative to the septum 112.
  • the sheath 114 can be positioned in the third channel 220 and coupled to the first portion 212 of the septum 112 to receive and couple the catheter 116 to the first portion 212.
  • the catheter 116 can be coupled, such as press fit, to the sheath 114 and extend through the sheath 114 to be partially positioned outside of the first portion 212 of the septum 112.
  • the sheath 114 can be formed of a material for press fitting into the septum 112, such as a biocompatible metal.
  • the press fit between the sheath 114 and the septum 112 can create a seal between the catheter 116 and the septum 112 to prevent fluid leakage out of the catheter 116 in the septum 112.
  • the catheter 116 can be formed of any traditional material and shape for a catheter, specifically for medicament delivery.
  • the catheter insertion mechanism 10 is depicted with the button 124 and the septum 112 in the raised position.
  • the base 102 is spaced apart from the cap 134 of the housing 110
  • the septum 112 is spaced apart from the opening 164 in the bottom 130 of the housing 110
  • the guide 144 of the needle hub 202 is positioned in the guiding portion of the groove in the housing 110.
  • the septum 112 is spaced apart from the first channel of the housing 110, where fluid cannot pass from the first channel to the second channel 218.
  • the needle assembly 118 When the button 124 is in this position, the needle assembly 118 is in the retracted position with the needle and the catheter 116 are each positioned within the inner wall 128 of the housing 110. In the retracted position, the needle extends only partially into the septum 112 so as to not intersect the second channel 218 in the septum 112. In these positions, the catheter 116 insertion device 10 can be placed over a user’s skin at a desired position for medicament injection.
  • the button 124 and the septum 112 are in the depressed position, where the base 102 contacts the cap to restrict further movement of the button 124, and the protrusion of the button 124 engages the detent in the inner wall 128 of the housing 110 to retain the button 124 in the depressed position.
  • the septum 112 is positioned within the opening of the bottom 130 of the housing 110 and adjacent the first channel to align the second channel 218 with the first channel to be in fluid communication therewith, permitting fluid flow from the first channel to the second channel 218.
  • the seals are pressed between the septum 112 and the housing 110 around the first channel and the second channel 218 to seal the interface between the two channels.
  • the needle assembly 118 When the button 124 is in the depressed position, the needle assembly 118 is in the extended position with the catheter 116 and the needle extending out of the housing 110. The needle extends further than the catheter 116 to extend out an end of the catheter 116, permitting the needle to puncture the skin of the user. In this position, the needle intersects the interface between the second channel 218 and the third channel 220, restricting fluid flow through the third channel 220 from the second channel 218. Further, when the button 124 is in the depressed position and the needle assembly 118 is in the extended position, the rotation of the needle hub through contact with the groove in the housing 110 causes the guide of the needle hub to move out of engagement with the detent in the button 124.
  • the biasing member 120 biases the needle hub toward the base 102 of the button 124, moving the needle assembly 118 back to the retracted position, thereby retracting the needle while the catheter 116 stays extended.
  • the catheter 116 insertion device 10 is depicted with the button 124 and the septum 112 in the depressed position, and the needle assembly 118 in the retracted position.
  • the needle hub is retracted to be in contact with or adjacent to the base 102 of the button 124, retracting the needle out of the catheter 116 and only partially positioned within the second portion of the septum 112.
  • a distal portion of the needle 200 can extend through the membrane 216 to form a press-fit seal with the membrane 216, preventing leakage through the membrane 216.
  • the needle is spaced apart from the second channel to permit fluid flow from the second channel to the third channel and out through the catheter 116.
  • the needle extends through the membrane, which seals the third channel at one end to restrict fluid flow from the second channel from exiting the third channel into the housing 110.
  • the septum 112 of the catheter 116 insertion device 10 can be at least partially formed of a soft deformable material so that the septum 112 contacts the housing 110 in the depressed position to form a seal around an interface between the first channel and the second channel without the need for seals, as described above with relation to FIGS. 4 and 5.
  • the septum 112 is depicted in the depressed position with the needle assembly 118 in the retracted position, where fluid flow is permitted from the first channel to the second channel.
  • the seal formed between the deformable septum and the housing 110 prevents leakage between the septum 112 and the housing 110 at the interface of the first channel and the second channel.
  • the septum 112 can include deformable arms positioned above and below the first channel 166 when the septum 112 is in the depressed position where the deformable arms can act similar to the seals 222, 224 described above and shown in FIGS. 5 and 7.
  • Each of the first portion 218 and the second portion 220 of the septum 112 can be formed of the deformable material to seal the interface between the first portion 218 and the second portion 220, and the interface between the septum 112 and the housing 110.
  • the septum 112 and the catheter insertion device 10 work substantially similar to the operation described above, and will not be described again for brevity.
  • the septum 112 can have a shape, for example conical, that permits the septum 112 to be press-fit with the housing 110 when the septum 112 is in the depressed position.
  • the press-fit between the septum 112 and the housing 110 permits the septum 112 to stay in place when the needle assembly 118 is retracted.
  • the alternative catheter insertion device 250 is substantially similar to the catheter insertion device 10 described above, and like features will not be described again for brevity.
  • the alternative catheter insertion device 250 includes a septum 252 with a first portion 254 and a second portion 256 coupled thereto, where the first portion 254 includes a flat surface 258 that contacts the housing 255 when the septum 252 is in a depressed position.
  • the septum 252 and housing 255 define channels similar to the channels 166, 218, 220 described above, and will not be described again for brevity.
  • the alternative catheter insertion device 250 further includes a needle assembly 260 having a needle hub 262 with a body 264 and a pair of guides 266 extending in opposing directions from the body 264, and a button 268 that defines a pair of grooves 270 that the pair of guides 266 engage.
  • the needle hub 262 further includes an arm 272 extending centrally from the body 264 along the central axis 140, where a needle 273 extends from the arm 272.
  • a biasing member 274 is disposed around the arm 272 and extends to the septum 252 to be engaged between the needle hub 262 and the septum 252.
  • the outer wall 280 further defines openings 281 on opposing sides of the outer wall 280 that are configured to receive a pair of deflectable arms 283 extending from the button 268.
  • the deflectable arms 283 contact an inside of the outer wall 280 to be compressed by the outer wall 280 when the button 268 is in the raised position and, when the button 268 is depressed to the depressed position, the arms 283 move toward the openings 281 where the arms 283 deflect outward into the openings 281 to hold the button 268 in the depressed position.
  • the button 268 can define a slot 285 extending therethrough for receiving a locking piece 287 that, when positioned in the slot 285, is positioned between a base 269 of the button 268 and the housing 255 to prevent the button 268 from being depressed before the locking piece 287 is removed.
  • the guides 266 contact the angled surface 282, which rotates the needle assembly 260 relative to the button 268.
  • the guides 266 move out of engagement with the engagement portion 278 and moves into the guiding portion 276, where the biasing member 274 biases the needle assembly 260 along the guiding portion 276 toward the base 269 of the button 268 to be in a retracted position.
  • FIG. 17 is a perspective view of an exemplary embodiment of a patch pump 1 according to an exemplary embodiment of the invention.
  • the patch pump 1 is illustrated with a see-through cover for clarity and illustrates various components that are assembled to form the patch pump l.
  • FIG. 18 is a view of the various components of the patch pump of FIG. 17, illustrated with a solid cover 2.
  • the various components of the patch pump 1 can include: a reservoir 4 for storing medicament; a pump 3 for pumping medicament out of the reservoir 4; a power source 5 in the form of one or more batteries; an insertion mechanism 7 for inserting an inserter needle with a catheter into a user’s skin; control electronics 8 in the form of a circuit board with optional communications capabilities to outside devices such as a remote controller and computer, including a smart phone; a dose button 6 on the cover 2 for actuating an medicament dose, including a bolus dose; and a base 9 to which various components above can be attached via fasteners 91.
  • the patch pump 1 also includes various fluid connector lines that transfer medicament pumped out of the reservoir 4 to the bolus or infusion site.
  • inserter mechanisms come in various configurations.
  • the inserter mechanism inserts a soft catheter into the skin.
  • typically the soft catheter is supported on a rigid insertion needle.
  • the insertion needle is inserted into the skin along with the soft catheter, and then retracted from the skin, leaving the soft catheter in the skin.
  • a soft catheter is not provided, and the insertion needle remains in the skin and forms a portion of the medicament flow path to deliver medicament until the bolus or infusion is finished.
  • Insertion needles are typically hollow, and need to be hollow if they form part of the medicament flow path. However, insertion needles that support a soft catheter and then retract can be solid or hollow.
  • the insertion needle deploys a soft catheter, and retracts but remains part of the medicament flow path, then the insertion needle should be hollow. However, if the insertion needle deploys a soft catheter and then retracts but does not form part of the medicament flow path, then the insertion needle can be solid or hollow. In either case, the insertion needle is preferably rigid enough to reliably penetrate the skin, but otherwise can be made flexible enough to provide comfort to the user.
  • FIG. 19 is a perspective view of an alternative design for a patch pump 1A having a flexible reservoir 4A, and illustrated without a cover. Such arrangement can further reduce the external dimensions of the patch pump 1A, with the flexible reservoir 4A filling voids within the patch pump 1A.
  • the patch pump 1A is illustrated with a conventional cannula insertion device 7A that inserts the cannula, typically at an acute angle, less than 90 degrees, at the surface of a user’s skin.
  • the patch pump 1A further comprises: a power source 5A in the form of batteries; a metering sub-system 41 that monitors the volume of medicament and includes a low volume detecting ability; control electronics 8A for controlling the components of the device; and a reservoir fill port 43 for receiving a refill syringe 45 to fill the reservoir 4A.
  • FIG. 20 is a patch-pump fluidic architecture and metering sub-system diagram of the patch pump 1A of FIG. 19.
  • the power storage sub-system for the patch pump 1A includes batteries 5A.
  • the control electronics 8A of the patch pump 1A can include a microcontroller 81, sensing electronics 82, pump and valve controller 83, sensing electronics 85, and deployment electronics 87 that control the actuation of the patch pump 1A.
  • the patch pump 1A includes a fluidics sub-system that can include a reservoir 4A, volume sensor 48 for the reservoir 4A, a reservoir fill port 43 for receiving a refill syringe 45 to refill the reservoir 4A.
  • the fluidics sub- system can include a metering system comprising a pump and valve actuator 411 and an integrated pump and valve mechanism 413.
  • the fluidics sub-system can further include an occlusion sensor 49, a deploy actuator 7, as well as the cannula 47 for insertion into a bolus or infusion site on the user’s skin.
  • the patch pump 1A can have deploy electronics 87 that operate an optional deploy actuator 7 provided in an automatic type of insertion device 7A in accordance with another example embodiment of an insertion device.
  • the architecture for the patch pumps of Figs. 17 and 18 is the same or similar to that which is illustrated in FIG. 20, and one or more components thereof can be used with the catheter insertion devices 12 and described herein in accordance with example embodiments of the present disclosure.

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  • Health & Medical Sciences (AREA)
  • Dermatology (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)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif d'insertion de cathéter comprenant : un boîtier définissant un premier canal ; un septum définissant un second canal et une ouverture s'étendant à partir du second canal ; et un cathéter au moins partiellement positionné à l'intérieur de l'ouverture du septum. Le septum est mobile par rapport au boîtier entre une première position et une seconde position. Dans la première position, le septum est espacé du premier canal du boîtier, et dans la seconde position, le septum est positionné adjacent au premier canal pour aligner le second canal avec le premier canal, permettant un écoulement de fluide du premier canal vers le second canal.
PCT/US2024/053682 2023-10-31 2024-10-30 Dispositif d'insertion de cathéter et procédé d'insertion d'un cathéter Pending WO2025096628A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363546541P 2023-10-31 2023-10-31
US63/546,541 2023-10-31

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WO2025096628A1 true WO2025096628A1 (fr) 2025-05-08

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080051714A1 (en) * 2006-08-23 2008-02-28 Medtronic Minimed, Inc. Infusion medium delivery system, device and method with needle inserter and needle inserter device and method
CA2826094A1 (fr) * 2011-02-09 2012-08-16 Becton, Dickinson And Company Dispositif de perfusion sous-cutane
CA2942749A1 (fr) * 2014-04-24 2015-10-29 Becton, Dickinson And Company Mecanisme d'introduction de catheter pour pompe a timbre
US20210283331A1 (en) * 2008-02-13 2021-09-16 Convatec Technologies Inc. Sealing between a cannula part and a fluid path
US20220143306A1 (en) * 2020-11-11 2022-05-12 Medtronic Minimed, Inc. Torsional insertion devices

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080051714A1 (en) * 2006-08-23 2008-02-28 Medtronic Minimed, Inc. Infusion medium delivery system, device and method with needle inserter and needle inserter device and method
US20210283331A1 (en) * 2008-02-13 2021-09-16 Convatec Technologies Inc. Sealing between a cannula part and a fluid path
CA2826094A1 (fr) * 2011-02-09 2012-08-16 Becton, Dickinson And Company Dispositif de perfusion sous-cutane
CA2942749A1 (fr) * 2014-04-24 2015-10-29 Becton, Dickinson And Company Mecanisme d'introduction de catheter pour pompe a timbre
US20220143306A1 (en) * 2020-11-11 2022-05-12 Medtronic Minimed, Inc. Torsional insertion devices

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