WO2025244976A1

WO2025244976A1 - Cannula with photosensitive coating

Info

Publication number: WO2025244976A1
Application number: PCT/US2025/029951
Authority: WO
Inventors: Sean Mcgrath
Original assignee: Becton Dickinson and Co
Current assignee: Becton Dickinson and Co
Priority date: 2024-05-20
Filing date: 2025-05-19
Publication date: 2025-11-27
Anticipated expiration: 2026-11-20

Abstract

A cannula for a drug delivery device includes a body having a first end and a second end positioned opposite the first end, with the body defining a central passageway and a side port positioned between the first and second ends, and a photosensitive coating positioned on an inner surface or outer surface of the body and covering the side port. The side port is configured to be uncovered when the photosensitive coating is exposed to ultraviolet or infrared light.

Description

CANNULA WITH PHOTOSENSITIVE COATING

CROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to United States Provisional Patent Application No. 63/649,739 entitled “Cannula with Photosensitive Coating” filed May 20, 2024, the disclosure of which is hereby incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

Field of the Invention

[0002] The present disclosure relates to a cannula with a photosensitive coating, such as a catheter or needle with a photosensitive coating.

Description of Related Art

[0003] Wearable medical devices, such as automatic injectors, have the benefit of providing therapy to the patient at a location remote from a clinical facility and/or while being worn discretely under the patient’s clothing. The wearable medical device can be applied to the patient’s skin and configured to automatically, or at user’s command, deliver a dose of a pharmaceutical composition within a predetermined time period after applying the wearable medical device to the patient’s skin, such as after a 27-hour delay or immediately upon actuation of the device. After the device delivers the pharmaceutical composition to the patient, the patient may subsequently remove and dispose of the device.

[0004] In certain circumstances, due to the medium in which the liquid is being injected, the flow of fluid leaving the device may be impaired, which can lead to increased pressure in the fluid line of the device. When the pressure rises above a certain threshold, the integrity of the fluid path may be compromised, causing a leak within the device and a failure to deliver the full dose of medicament. A fluid leak within the device may also cause damage to the device and subsequent system failures, as well as potential contamination concerns due to contact between the fluid and the device.

[0005] Human subcutaneous tissue is composed of various cell types, extracellular matrix (ECM) constituents, microstructures, and macroscopic arrangement of cells and ECM. Those elements contribute to the mechanical properties of the tissue. The tissue may also include the lymphatic system and blood vessels, and has intrinsic fluid absorption and retention properties. These characteristics vary among individuals, location within the body, and over time may cause variable degrees of resistance to the infusion of fluids at the site of injection. When the resistance of the tissue is too high or the absorption rate is too low for a given delivery flow rate from the device, the pressure may build up and reach values above the threshold where the fluid line and other components may be compromised.

SUMMARY OF THE INVENTION

[0006] In one aspect or embodiment, a cannula for a drug delivery device includes a body having a first end and a second end positioned opposite the first end, with the body defining a central passageway and a side port positioned between the first and second ends, and a photosensitive coating positioned on an inner surface or outer surface of the body and covering the side port. The side port is configured to be uncovered when the photosensitive coating is exposed to ultraviolet or infrared light.

[0007] The body may be at least one of a catheter and a needle. The photosensitive coating may be positioned on the inner surface of the body. The photosensitive coating may be positioned on the outer surface of the body. The side port may include a plurality of side ports. [0008] The photosensitive coating may include at least one of polyethylene glycol (PEG), modified PEG, and alginate covalently bonded with PEG.

[0009] In one aspect or embodiment, a drug delivery device includes a reservoir configured to receive a fluid, and a cannula in fluid communication with the reservoir, with the cannula configured to be inserted into subcutaneous tissue or muscle tissue of a patient, with the cannula including a body having a first end and a second end positioned opposite the first end, the body defining a central passageway and a side port positioned between the first and second ends, and a photosensitive coating positioned on an inner surface or outer surface of the body and covering the side port. The side port is uncovered when the photosensitive coating is exposed to ultraviolet or infrared light. The drug delivery device also includes a light source configured to direct ultraviolet or infrared light to the photosensitive coating, and a pump configured to deliver a fluid from the reservoir to the cannula, where the side port is configured to be uncovered when the photosensitive coating is exposed to the ultraviolet or infrared light from the light source.

[0010] The light source may be configured to direct ultraviolet or infrared light through the central passageway of the body of the cannula. The light source may be configured to be activated when a predetermined threshold is passed during delivery of fluid using the pump. The predetermined threshold may include at least one of a current value, a voltage value, a pressure value, and a flow value. The drug delivery device may further include a processor configured to monitor the predetermined threshold and activate the light source when the predetermined threshold is passed. The processor may be configured to deactivate the pump for a predetermined time period after activation of the light source.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following descriptions of embodiments of the disclosure taken in conjunction with the accompanying drawings, wherein:

[0012] FIG. 1 is a perspective view of a drug delivery device according to one aspect or embodiment of the present application;

[0013] FIG. 2 is a perspective view of the drug delivery device of FIG. 1, with a top cover removed;

[0014] FIG. 3 is a schematic of the drug delivery device of FIG. 1;

[0015] FIG. 4 is a cross-sectional view of the drug delivery device of FIG. 1;

[0016] FIG. 5 is a perspective view of a drug delivery device according to a further aspect or embodiment of the present application;

[0017] FIG. 6 is a cross-sectional of the drug delivery device of FIG. 5;

[0018] FIG. 7 is a cross-sectional view of the drug delivery device of FIG. 5;

[0019] FIG. 8 is a cross-sectional view of a cannula of the drug delivery device of FIG. 1 or FIG. 5 according to one aspect or embodiment of the present application, showing a coating covering a side port of the cannula;

[0020] FIG. 9 is a cross-sectional view of the cannula of FIG. 8, showing a side port of the cannula uncovered;

[0021] FIG. 10 is a cross-sectional view of a cannula of the drug delivery device of FIG. 1 or FIG. 5 according to one aspect or embodiment of the present application, showing a coating covering a side port of the cannula; and

[0022] FIG. 11 is a cross-sectional view of the cannula of FIG. 8, showing a side port of the cannula uncovered.

[0023] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary embodiments of the disclosure, and such exemplifications are not to be construed as limiting the scope of the disclosure in any manner. DETAILED DESCRIPTION OF THE INVENTION

[0024] The following description is provided to enable those skilled in the art to make and use the described aspects contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0025] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the invention. Hence, specific dimensions and other physical characteristics related to the aspects disclosed herein are not to be considered as limiting.

[0026] Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood to encompass the beginning and ending values and any and all subranges or subratios subsumed therein. For example, a stated range or ratio of “1 to 10” should be considered to include any and all subranges or subratios between (and inclusive of) the minimum value of 1 and the maximum value of 10; that is, all subranges or subratios beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less.

[0027] The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.

[0028] As used herein, “at least one of’ is synonymous with “one or more of’. For example, the phrase “at least one of A, B, and C” means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, “at least one of A, B, and C” includes one or more of A alone; or one or more of B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C.

[0029] Referring to FIGS. 1-4, a drug delivery device 10 includes a reservoir 12, a power source 14, an insertion mechanism 16, control electronics 18, a cover 20, and a base 22. In one aspect or embodiment, the drug delivery device 10 is a wearable automatic injector, such as an insulin or bone marrow stimulant delivery device. The drug delivery device 10 may be mounted onto the skin of a patient and triggered to inject a pharmaceutical composition from the reservoir 12 into the patient. The drug delivery device 10 may be pre-filled with the pharmaceutical composition, or it may be filled with the pharmaceutical composition by the patient or medical professional prior to use.

[0030] The drug delivery device 10 is configured to deliver a dose of a pharmaceutical composition, e.g., any desired medicament, into the patient’s body by a subcutaneous injection at a slow, controlled injection rate. Exemplary time durations for the delivery achieved by the drug delivery device 10 may range from about 5 minutes to about 60 minutes, but are not limited to this exemplary range. Exemplary volumes of the pharmaceutical composition delivered by the drug delivery device 10 may range from about 0.1 milliliters to about 10 milliliters, but are not limited to this exemplary range. The volume of the pharmaceutical composition delivered to the patient may be adjusted.

[0031] Referring again to FIGS. 1-4, in one aspect or embodiment, the power source 14 is a DC power source including one or more batteries. The control electronics 18 include a microcontroller 24, sensing electronics 26, a pump and valve controller 28, sensing electronics 30, and deployments electronics 32, which control the actuation of the drug delivery device 10. The drug delivery device 10 includes a fluidic sub-system that includes the reservoir 12, a volume sensor 34 for the reservoir 12, a reservoir fill port 36, and a metering sub-system 38, including a pump and valve actuator 40 and a pump and valve mechanism 42. The fluidic sub-system may further include an occlusion sensor 44, a deploy actuator 46, a cannula 48 for insertion into a patient’s skin, and a fluid line 50 in fluid communication with the reservoir 12 and the cannula 48. In one aspect or embodiment, the insertion mechanism 16 is configured to move the cannula 48 from a retracted position positioned entirely within the device 10 to an extended position where the cannula 48 extends outside of the device 10. In one aspect or embodiment, the cannula 48 is a catheter, which may be a soft, flexible catheter, a rigid catheter, or a combination thereof. In one aspect or embodiment, the cannula 48 is positioned over an insertion needle that pierces a patient’s skin to place the cannula 48, with the insertion needle subsequently retracted. The drug delivery device 10 may operate in the same manner as discussed in U.S. Patent No. 10,449,292 to Pizzochero et al.

[0032] In further aspects or embodiments, the drug delivery device 10 is a pen injector, autoinjector, or a syringe.

[0033] Referring to FIGS. 5-7, in a further aspect or embodiment, a drug delivery device 100 includes a housing 102, a pump assembly 104, a reservoir 106 having a stopper 108 and a closure 110, a valve assembly 112, and a needle actuation assembly 114 including a cannula 148. Although one cannula 148 is shown, the cannula 148 may include one or more cannulas. Actuation of the drug delivery device 100 via a button 150 causes the needle actuation assembly 114 to move the cannula 148 from a retracted position to an extended position while simultaneously causing the pump assembly 104 to move the reservoir 106 into engagement with the valve assembly 112, which, in turn, punctures the closure 110 of the reservoir 106. Upon puncturing of the closure 110 of the reservoir 106, the pump assembly 104 is in fluid communication with the cannula 148 via flow tube (not shown), which allows the pump assembly 104 to move the stopper 108 within the reservoir 106 to deliver fluid from the reservoir 106 to the cannula 148. In use, the drug delivery device 100 is worn or placed on a skin surface of a patient with the button 150 actuating the device 100 to deliver a dose of medication within the reservoir 106 to the patient via the cannula 148, which is inserted into the patient. In one aspect or embodiment, the cannula 148 is a needle. After completion of delivery of the dose of medication, the cannula 148 is automatically retracted within the housing 102 of the drug delivery device 100.

[0034] In one aspect or embodiment, the pump assembly 104 is driven by one or more springs, although other suitable power sources or arrangements may be utilized. In one aspect or embodiment, the reservoir 106 is a container having a cylindrical barrel. It is further contemplated herein that the cannula 148 may be supported by a hub, which may be in communication with a remote fluid source that is not housed within the same structure as the cannula. In certain configurations, the hub and supported cannula may be connected to the remote fluid source by a length of tubing. For example, the cannula may be supported by a hub in communication with a remote infusion pump, IV bag, or the like.

[0035] Referring to FIGS. 8-10, in one aspect or embodiment of present application, the cannula 48, 148 includes a body 202 having a first end 204 and a second end 206 positioned opposite the first end 204 and a photosensitive coating 210 positioned on an inner surface (FIGS. 10 and 11) or outer surface (FIGS. 8 and 9) of the body 202. The body 202 defines a central passageway 212 and a side port 214 positioned between the first and second ends 204, 206. The photosensitive coating 210 covers the side port 214. The side port 214 is configured to be uncovered (FIGS. 9 and 11) when the photosensitive coating 210 is exposed to ultraviolet or infrared light.

[0036] As discussed above due to ECM constituents, microstructures, and microscopic arrangement of cells and ECM, the intrinsic fluid absorption and retention properties of a patient can vary among individuals, location within the body, and over time may cause variable degrees of resistance to the infusion of fluids at the side of injection. In certain circumstances, the flow of fluid leaving the cannula 48, 148 from the drug delivery device 10, 100 may be impaired by an area of tissue with a high degree of resistance which can lead to increased pressure in the fluid line of the device as well as reduced diffusion and dispersal characteristics of the delivery fluid. The side port 214, which may include one or more side ports 214 spaced apart along a length of the body 202, provides an alternative path for fluid delivery into the subcutaneous tissue if the pressure increase at the second end 206 through the central passageway 212 is too high.

[0037] In some aspects or embodiments, the body 202 of the cannula 48, 148 may be at least one of a catheter and a needle.

[0038] In some aspects or embodiments, the drug delivery device 10, 100 includes a light source 220 configured to direct ultraviolet or infrared light to the photosensitive coating 210. In one aspect or embodiment, the light source 220 is incorporated within the device 10, 100, although the light source 220 may be positioned externally of the device 10, 100. The light source 220 is configured to have visual access to the fluid path.

[0039] In some aspects or embodiments, the light source 220 is configured to direct ultraviolet or infrared light through the central passageway 212 of the body 202 of the cannula 48, 148. As shown in FIG. 9, the ultraviolet or infrared light passes through the central passageway 212 and through the side port(s) 214 to change or affect the properties of the photosensitive coating 210 on the outer surface of the body 202 such that fluid can flow through the central passageway 212 and out the side port(s) 214 and into a patient. As shown in FIG. 11, the ultraviolet or infrared light passes through the central passageway 212 to change or affect the properties of the photosensitive coating 210 on the inner surface of the body 202 such that fluid can flow through the central passageway 212 and out the side port(s) 214 and into a patient. Although only the portion of the photosensitive coating 210 covering the side port(s) 214 is shown to be removed in FIG. 11, the entire photosensitive coating 210 may be affected or degraded by the ultraviolet or infrared light. In some aspects or embodiments, the photosensitive coating 210 is degraded to allow the fluid to flow through the degraded coating. [0040] In some aspects or embodiments, the light source 220 is configured to be activated when a predetermined threshold is passed during delivery of fluid using the pump, such as the metering sub-system 38 or the pump assembly 104. In one aspect or embodiment, the predetermined threshold is at least one of a current value, a voltage value, a pressure value, and a flow value. In one aspect or embodiment, the drug delivery device 10, 100 includes a processor, such as microcontroller 24, configured to monitor the predetermined threshold and activate the light source 220 when the predetermined threshold is passed. The processor is configured to deactivate the pump for a predetermined time period after activation of the light source 220. The delay allows time for the change in properties of the photosensitive coating 210 before resuming delivery once the photosensitive coating 212 has been altered enough to allow the opening of the side port(s) 214 of the body 202.

[0041] The photosensitive coating 210 of the cannula 48,148 may include at least one of polyethylene glycol (PEG), modified PEG, and alginate covalently bonded with PEG. The photosensitive coating 210 of the cannula 48, 148 can be applied via a spray or dip coating process. In some aspects or embodiments, the speed of degradation is controlled by the polymer formulation along with the thickness of the coating applied.

[0042] Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

THE INVENTION CLAIMED IS

1. A cannula for a drug delivery device comprising: a body having a first end and a second end positioned opposite the first end, the body defining a central passageway and a side port positioned between the first and second ends; and a photosensitive coating positioned on an inner surface or outer surface of the body and covering the side port, wherein the side port is configured to be uncovered when the photosensitive coating is exposed to ultraviolet or infrared light.

2. The cannula of claim 1, wherein the body comprises at least one of a catheter and a needle.

3. The cannula of claim 1, wherein the photosensitive coating is positioned on the inner surface of the body.

4. The cannula of claim 1, wherein the photosensitive coating is positioned on the outer surface of the body.

5. The cannula of claim 1, wherein the side port comprises a plurality of side ports.

6. The cannula of claim 1 , wherein the photosensitive coating comprises at least one of polyethylene glycol (PEG), modified PEG, and alginate covalently bonded with PEG.

7. A drug delivery device comprising: a reservoir configured to receive a fluid; a cannula in fluid communication with the reservoir, the cannula configured to be inserted into subcutaneous tissue or muscle tissue of a patient, the cannula comprising: a body having a first end and a second end positioned opposite the first end, the body defining a central passageway and a side port positioned between the first and second ends, and a photosensitive coating positioned on an inner surface or outer surface of the body and covering the side port, wherein the side port is uncovered when the photosensitive coating is exposed to ultraviolet or infrared light; a light source configured to direct ultraviolet or infrared light to the photosensitive coating; and a pump configured to deliver a fluid from the reservoir to the cannula, wherein the side port is configured to be uncovered when the photosensitive coating is exposed to the ultraviolet or infrared light from the light source.

8. The drug delivery device of claim 7, wherein the light source is configured to direct ultraviolet or infrared light through the central passageway of the body of the cannula.

9. The drug delivery device of claim 7, wherein the body comprises at least one of a catheter and a needle.

10. The drug delivery device of claim 7, wherein the light source is configured to be activated when a predetermined threshold is passed during delivery of fluid using the pump.

11. The drug delivery device of claim 10, wherein the predetermined threshold comprises at least one of a current value, a voltage value, a pressure value, and a flow value.

12. The drug delivery device of claim 11, further comprising a processor configured to monitor the predetermined threshold and activate the light source when the predetermined threshold is passed.

13. The drug delivery device of claim 12, wherein the processor is configured to deactivate the pump for a predetermined time period after activation of the light source.

14. The drug delivery device of claim 7, wherein the photosensitive coating comprises at least one of polyethylene glycol (PEG), modified PEG, and alginate covalently bonded with PEG.