Delivery device and coated needle or cannula

Abstract

The drug delivery device is provided with a stainless steel needle or cannula, the patient end of which has a protective outer layer covering the surface of the needle or cannula. The protective outer layer has a thickness and is oriented to avoid or minimize contact between the stainless steel and patient tissue to avoid or reduce allergic reactions due to tissue contact with nickel in the stainless steel. The protective outer layer may be a metallic coating of a non-allergenic metal such as gold or other coating material that can cover the exposed surface of the stainless steel needle to avoid direct contact with the patient.

Description

[Technical Field]

[0001] The present invention relates to delivery devices having a coating that inhibits allergic reactions when in contact with a patient's tissue, and to cannulas or needles for delivery devices. The cannula or needle is made of stainless steel and may have an outer layer or coating of a non-allergenic material to prevent or minimize direct contact of the stainless steel with the patient during use. [Background Art]

[0002] Various injection devices including conventional cannulas or needles for introducing drugs intravenously, intramuscularly or subcutaneously are manufactured. Cannulas or needles are generally made of stainless steel. Some patients exhibit an allergic reaction to nickel in stainless steel cannulas or needles. In particular, long-term exposure of stainless steel in contact with a patient's skin or other tissue can cause allergic reactions and discomfort in the patient.

[0003] Common examples of delivery devices include syringe or pen-type injector delivery devices for facilitating self-administration of parenteral medications. A pen needle is a component of a needle-based injection system, consisting of two cannulas assembled to a hub using adhesive. The hub has internal threads, allowing it to be attached to a pen-type injector device. The attachment of the pen needle allows the proximal end of the cannula to penetrate the rubber septum of the drug cartridge, forming a fluid channel. For many diabetic patients, maintaining blood glucose control is achieved by injecting insulin into the subcutaneous (SC) tissue multiple times daily using a convenient and discreet pen-type injector delivery device as an alternative to vials and syringes. Many pen-type injectors are commercially available in single-use or multi-use configurations, each offering a variety of patient-centered features. The distal pen needle cannula connects to a delivery site that provides a conduit for delivery. The design of the pen needle aims to enable consistent delivery to the target tissue space, minimize drug leakage, and reduce pain / discomfort and site effects such as bleeding or bruising associated with injection. The key design features, such as needle length / gauge and hub surface shape, along with the delivery system mechanism and injection technique, determine the success of the injection.

[0004] Injections can be administered intradermally, subcutaneously, and intramuscularly (IM) to the skin. For many types of injectable drug therapies, including insulin, the SC region is preferred for injection. See, for example, Non-Patent Document 1.

[0005] Needles, such as those with a length of approximately 4 mm to 5 mm, are adapted to inject drugs to a specified target depth in the subcutaneous region. This delivery device provides a structure that allows the needle to be consistently inserted to the desired target depth. Conventional pen needles have a cannula supported by an axial support extending from a hub. The support forms a narrow portion and a relatively wide base that does not come into contact with the skin during injection. In other pen needles known in the art, the distal surface of the hub positioned relative to the injection site may be relatively large and may have a slight taper at the end. The end of the hub can engage with the skin when the cannula is inserted at a certain angle to the surface of the patient's skin. [Prior art documents] [Non-patent literature]

[0006] [Non-Patent Document 1] Lo Presti et al., Skin and subcutaneous thickness at injection sites in children with diabetes in relation to ultrasound findings and injection recommendations, Pediatric Diabetes (2012) [Overview of the project] [Problems that the invention aims to solve]

[0007] While conventional devices are generally suitable for their intended applications, there is still a need for improved devices to deliver drugs or medications to selected target regions. [Means for solving the problem]

[0008] The present invention relates to a delivery device, such as an injection device, having a stainless steel component coated with a protective layer to prevent or inhibit direct contact between the stainless steel and the object. In one embodiment, the delivery device is a syringe or needle hub for use with an injection device, such as a pen-type syringe. In other embodiments, the delivery device may be an injection set or patch pump for providing continuous or sustained delivery of a drug.

[0009] The disclosed delivery device includes a stainless steel component. In the embodiments described, the stainless steel component is a cannula or needle having a coating or outer layer made of a non-allergenic material to prevent or inhibit allergic reactions with metals or compounds within the cannula or needle. The cannula or needle is typically made of stainless steel suitable for surgical purposes. The coating or protective layer covers the stainless steel to avoid or minimize contact with patient tissue during use.

[0010] The coating or protective layer on the cannula or needle can be any suitable material that adheres to the cannula or needle during use and can inhibit or reduce surface contact between the stainless steel and the patient's tissue while the cannula or needle is in use and in contact with the patient's tissue. In one embodiment, the coating is a metal coating that does not induce an allergic reaction when in contact with the patient's tissue and effectively prevents or reduces direct contact between the stainless steel and the tissue during use. The metal coating can be a precious metal such as gold. Other metals include silver, palladium, ruthenium, osmium, and rhenium.

[0011] A delivery device within a single implant may be any suitable delivery device that utilizes a cannula or needle for delivering a drug to a patient. The delivery device may be a syringe having a needle extending from the distal end of a syringe. In other embodiments, the delivery device may be an infusion set having a flexible cannula or catheter, a patch pump having a flexible cannula or catheter, or an IV catheter having an insertion or introduction needle for introducing the delivery device into the patient.

[0012] In one embodiment, the delivery device is an injection device configured to inject a drug, medication, or other substance into a patient at a desired depth into the surface of the skin. The delivery device may be a needle hub having a hub surface that forms a contact surface with the skin, and the hub surface has a configuration for controlling and optimizing the depth of penetration by the needle or cannula. The needle hub can be optimized to determine the depth of insertion of the cannula or needle so that the entire length of the exposed cannula or needle is inserted into the tissue.

[0013] In one embodiment, the delivery device is a syringe having a needle with a sharp tip that penetrates the patient's skin and extends from the distal end to deliver a drug. The needle may be made of stainless steel. At least a portion of the outer surface of the needle may be covered or coated with a material that forms a protective layer. The protective layer does not cause an allergic reaction with the skin, isolates the stainless steel needle from the patient, prevents contact between the stainless steel needle and tissue, and suppresses or reduces an allergic reaction by the patient.

[0014] The coating on the needle can cover at least a portion of the needle's length. In one embodiment, the coating covers the entire length or substantially the entire length of the exposed portion of the needle intended to contact the patient's tissue. In another embodiment, the coating can cover the distal end portion configured to contact the patient's tissue. In yet another embodiment, the coating can cover only a portion of the needle spaced away from the distal end, so that the coated portion contacts the patient's tissue to prevent contact between the stainless steel and the tissue.

[0015] In another embodiment, the needle may be an insertion needle or guidewire for the catheter or flexible cannula of the infusion set. In this embodiment, the distal end of the needle extending from the catheter or flexible cannula may be covered with a protective coating, while the portion of the needle inside the catheter or flexible cannula that does not come into contact with the skin is not covered with a protective coating.

[0016] The device features a delivery device for delivering substances such as drugs to a patient. In one embodiment, the delivery device includes a needle made of stainless steel, and at least a portion of the needle is covered with a protective coating to prevent contact between the stainless steel and the patient's tissue.

[0017] A method for preventing or inhibiting an allergic reaction in a patient is provided by preventing the stainless steel component of a delivery device from coming into direct contact with the patient's skin or tissue. The method involves bringing a delivery device into contact with the patient's skin or tissue, wherein the delivery device is coated with a non-allergenic material on the portion of the delivery device that comes into contact with the patient in order to prevent or inhibit an allergic reaction in the patient caused by stainless steel.

[0018] It will be understood that each preferred or optional feature of various embodiments may be combined with other features, and that features described in combination with one or more specific features may be combined with one or more other features of other embodiments.

[0019] These and other features of the present invention will become apparent from the following detailed description of the invention, and various embodiments of the invention will be disclosed together with the drawings. [Brief explanation of the drawing]

[0020] The following is a brief description of the drawing. [Figure 1] Figure 1 is an elevation view of a syringe and needle in one embodiment. [Figure 2] Figure 2 is an elevation view of a needle in one embodiment having a coating of a non-allergenic material. [Figure 3] Figure 3 is an elevation view of a needle having a coating of a non-allergenic material at its distal end. [Figure 4] Figure 4 is an elevation view of a needle having a coating of a non-allergenic material on a portion of the needle spaced apart from the distal tip. [Figure 5]Figure 5 is a side view of a partial cross-section showing a needle inserted into a lumen. [Figure 6] Figure 6 is a side view of a catheter and a catheter insertion needle. [Figure 7] Figure 7 is a side cross-sectional view of a pen needle hub. [Figure 8] Figure 8 is a side cross-sectional view of a delivery device having a flexible cannula and an introducer needle. DESCRIPTION OF EMBODIMENTS

[0021] The delivery device described may typically be a suitable device having a stainless steel member that contacts and penetrates the skin during use. Examples of delivery devices are pen needles or syringes. A pen needle refers to a needle hub attached to a pen-type injection device for injecting a drug or other substance into a patient. The terms needle and cannula refer to a thin tubular member for insertion into an injection site in a subject that has a lumen for delivering a substance to a patient. A needle typically has a sharpened end for penetrating the patient's skin. Distal direction is the direction toward the injection site, and proximal direction is the opposite direction. Axial direction refers to a direction along or parallel to the longitudinal axis of the needle and the needle hub, and radial direction refers to a direction perpendicular to the axial direction. The pen-type injection device may be a standard device as known in the art, wherein a needle hub is attached to an end of the pen-type injector for delivering a substance to a patient. After use, the needle hub is removed, discarded, and replaced with a new needle hub for subsequent injections. Features of different embodiments may be used in combination and interchangeably where the embodiments are not mutually inconsistent.

[0022] The delivery device described and illustrated has at least one stainless steel component that is protected from direct contact with patient tissue by a protective layer or coating to prevent direct contact of the stainless steel component with patient tissue or skin. The stainless steel may be surgical-grade stainless steel such as stainless steel type 304 with a minimum chromium content of 18% and a minimum nickel content of 8% by weight. The stainless steel has a nickel content that may cause an allergic reaction when it comes into contact with the skin of a subject allergic to nickel. A stainless steel needle inserted into the patient's skin or tissue may increase the risk of an allergic reaction at the injection site. An allergic reaction to nickel may result in the formation of a rash or bumps, itching, redness, discoloration, dry patches, or blisters on the skin. In some cases, the allergic reaction may be severe.

[0023] The present invention relates to drug delivery devices, such as injection devices, having stainless steel components such as needles or cannulas covered with a protective layer to inhibit such allergic reactions. Stainless steel cannulas or needles can have a chromium content of about 10.5% to about 35%. In one embodiment, the cannula or needle can have a chromium content of about 11% to 24%, typically about 11.5% to about 14.5%. Needles can be obtained in length and gauge suitable for the intended injection. Preferred needle lengths for syringes can be 1 inch to 2 inches (2.54 cm to 5.08 cm), and commonly 1.5 inches (3.81 cm). Needle gauge is also selected based on the intended application and can range from 16 gauge to 36 gauge. Insertion needles or delivery needles can be, for example, 16 to 18 gauge. Needles for subcutaneous injection are 1 / 2 to 5 / 8 inch (1.27 cm to 1.59 cm) in length and may be 25 to 30 gauge. In one embodiment, the needle or cannula may be, for example, 4–8 mm in length and 31–36 gauge. In other embodiments, the needle or cannula may be of a different gauge suitable for the intended purpose.

[0024] A delivery device can be any suitable device for delivering medication to a patient, whether using a needle or cannula, or by introducing a catheter into the patient. Examples of delivery devices may be syringes, catheters, reusable or disposable injector devices, auto-injectors, syringes, patch pumps, or other delivery devices.

[0025] In the first embodiment shown in Figure 1, the delivery device is a syringe 10 having a syringe barrel 12, a distal tip 14, and a proximal tip 16. A plunger 18 is provided for dispensing the contents of the syringe in a conventional manner. A needle 20 extends from the distal tip 14 and has an outer surface exposed to penetrate the patient's skin.

[0026] A needle 20, as shown in the embodiment of Figure 2, has a proximal end 22 for binding to a delivery device such as a syringe 10, a sharp distal tip 24, and a body 26 extending between the distal tip 22 and the proximal end 22. In the shown embodiment, a lumen 28 extends axially through the needle body 26 to deliver a drug from the delivery device to the patient. Needles are typically made of stainless steel, such as surgical-grade stainless steel. At least a portion of the outer surface of the needle body 26 has a protective layer or coating 30 to surround or enclose the surface of the stainless steel to prevent the outer surface of the needle from coming into contact with the patient. The protective layer is made of a non-allergenic material that does not cause an allergic reaction when in contact with the patient's skin or tissue, and prevents the patient from coming into direct contact with the stainless steel.

[0027] In one embodiment, the protective layer 30 is a metal coating applied directly to the outer surface of the stainless steel needle. The protective layer has a thickness and orientation to prevent or minimize contact between the stainless steel and the patient during use. The metal is typically a precious metal. A particularly suitable metal protective layer for stainless steel is gold, which can be applied by various coating techniques, such as a standard gold electroplating process. Gold also provides a visual indicator for the patient to identify the delivery device having the protective layer. Other metals that can provide a suitable protective layer include platinum, iridium, silver, rhenium, ruthenium, rhodium, palladium, iridium, and osmium. In other embodiments, the protective layer is anodized thing, The material may be a ceramic material or a polymer coating. The polymer coating can also provide a lubricating effect to help insert the needle into the patient. The outer surface of the protective layer may contain conventional lubricants used for needles and cannulas. Examples of lubricants may be silicone oil or a silicone polymer or resin coating fixed to the outer surface of stainless steel.

[0028] As shown in Figure 2, the protective layer is formed on the outer surface of the needle body 26 and substantially covers the entire surface extending from the proximal end 22 to the distal tip. In one embodiment, the protective layer may be formed on the bevel 32 of the needle 20.

[0029] The needle body 26 of the needle 20 has a distal end portion 34 with an outer surface, a proximal end portion 36 with an outer surface, and an intermediate surface 38 between the distal end portion 34 and the proximal end portion 36. In the embodiment shown in Figure 2, the outer protective layer covers the distal end portion 34, the proximal end portion 36, and the intermediate surface 38.

[0030] In another embodiment shown in Figure 3, the protective coating 30 is formed only on the distal end portion 36. The intermediate surface 38 and proximal end portion 36 in the shown embodiment are not intended to come into contact with the target, as these portions are not covered by the protective layer. In the embodiment shown in Figure 3, the needle 20 is configured such that the distal end portion is positioned within the patient's tissue or skin, while the intermediate surface and proximal end portion are not covered by the protective layer 30. In this embodiment, the protective layer 30 covers the portion of the needle that typically comes into contact with the skin or tissue during use. As in the previous embodiment, the protective layer may be a gold coating applied directly to the surface of the stainless steel needle.

[0031] In the embodiment shown in Figure 4, the needle 20 has a portion of the needle body 26 covered with a protective layer to cover the stainless steel surface. As shown, the protective layer 30 is applied to the intermediate portion 30 spaced apart from the distal end portion 34. In the embodiment shown, the protective layer 30 is also spaced apart from the proximal end 36 of the needle.

[0032] The needle 20 in Figure 4 may be an intravenous (IV) needle configured to be positioned within a patient's vein or artery. The IV needle may be for introducing a substance into the patient or it may be a blood collection needle. As shown in Figure 5, the needle is inserted into a vein 42 through the skin 40, with the distal tip 14 and distal end portion 34 positioned within the lumen 44 of the vein 42 and not in direct contact with tissue. The intermediate surface 38, covered by a protective layer 30, is oriented on the needle so that only the intermediate surface portion and the protective layer are in direct contact with tissue or skin at the insertion site, thereby suppressing allergic reactions due to nickel contained in the stainless steel.

[0033] In another embodiment shown in Figure 6, the delivery device is a catheter 44 having a lumen, a distal end 46, a proximal end 48, and a catheter hub 50 coupled to the distal end of the catheter 44. The catheter is typically a flexible catheter made from a polymer material for introducing drugs into a patient. An introduction needle 52 is initially oriented into the lumen of the catheter 44 and extends from the distal end of the catheter to introduce the flexible catheter to a selected position. Once the catheter is in the selected position, the needle can be detached from the catheter so that the catheter can introduce drugs into the patient. The introduction needle 52 has a proximal end 54 coupled to a needle retractor mechanism 56 to retract the introduction needle once the catheter is in place in the patient. The introduction needle is made of stainless steel, as in the previous embodiment. Typically, the introduction needle has a lumen and a sharp distal tip, as shown. The introduction needle 52 has a distal end portion 58 that extends from the distal end of the catheter 44 and an intermediate portion 60 that is spaced apart from the distal end portion 58 and positioned inside the catheter so that only the distal end portion is exposed. In the shown embodiment, the distal end portion 58 of the introduction needle 52 has a protective layer 62 that forms a coating to cover the surface of the stainless steel introduction needle.

[0034] In a further embodiment shown in Figure 7, the delivery device is a pen needle 64. The pen needle 64 in the shown embodiment has an inner shield 66 for covering a needle 68 and an outer cover 70. The pen needle 64 has a needle hub 72 having an open proximal end 74 for connecting to a delivery pen. The needle 68 in the shown embodiment has a length extending through the needle hub 72 and a sharp proximal end 76 for penetrating the septum of the delivery pen. As shown in Figure 7, the needle 68 has an exposed distal portion 78 that extends from the needle hub to penetrate the patient's skin and deliver the drug. As in the previous embodiment, the exposed portion 78 of the needle 68 is covered with a protective layer 80 of a non-allergenic material such as a gold coating. The protective layer coating on the exposed distal portion of the needle prevents the stainless steel needle from coming into direct contact with the patient's tissue during drug delivery to prevent or inhibit allergic reactions due to nickel in the stainless steel.

[0035] In another embodiment shown in Figure 8, the delivery device 82 is a patch pump or infusion device. The patch pump 82 and a soft, flexible catheter 84 are connected to a fluid source to deliver a drug to the patient. The insertion needle 86 is initially positioned within the lumen of the catheter 84, with its distal end 88 extending from the distal end of the catheter. The patch pump includes an insertion actuator 90 for inserting the insertion needle and catheter into the patient, and then retracts the insertion needle so that the catheter can deliver the drug. In the embodiment shown, the distal end 88 of the insertion needle 86 is provided with a protective layer to prevent the patient's tissue from coming into contact with the stainless steel insertion needle during insertion and to suppress allergic reactions due to the nickel contained in the stainless steel.

[0036] The described delivery device is suitable for use in a method of injecting drugs or medications into a patient and preventing or inhibiting allergic reactions to stainless steel. The method involves providing the delivery device with a drug compartment and a needle having a distal end configured to penetrate the patient, the surface of which the needle comes into contact with the patient covered with a non-allergenic protective layer. The protective layer may be a precious metal coating, such as gold, on the surface of the stainless steel to prevent contact between the stainless steel and the patient.

[0037] The above description of preferred embodiments should not be considered to limit the invention as defined by the appended claims. This disclosure is intended to enable those skilled in the art to carry out the described variations of the invention without departing from the scope of the invention. The numerical limitations herein and in the claims are understood to be limited by the modifying phrase “about,” and small deviations resulting in equivalent outcomes are within the scope of the invention. Features disclosed in relation to one embodiment or independent claim or limitations of a dependent claim may be combined with another embodiment or a different independent claim without departing from the scope of the invention.

Claims

1. A drug delivery device, A distribution mechanism connected to a reservoir configured to contain a drug, A stainless steel needle connected to the distribution mechanism for delivering the drug, wherein the stainless steel needle has an outer surface for contacting a patient, and the stainless steel needle has a protective layer of a non-allergenic material covering at least a portion of the stainless steel needle to allow the stainless steel needle to be in direct contact with the patient. The stainless steel needle has a distal end, a proximal end, and an intermediate surface oriented between the distal end and the proximal end. A drug delivery device characterized in that the protective layer is made of gold and is formed only on the distal end of the needle.

2. A drug delivery device, A distribution mechanism connected to a reservoir configured to contain a drug, A stainless steel needle connected to the distribution mechanism for delivering the drug, wherein the stainless steel needle has an outer surface for contacting a patient, and the stainless steel needle has a protective layer of a non-allergenic material covering at least a portion of the stainless steel needle to allow the stainless steel needle to be in direct contact with the patient. The stainless steel needle has a distal end, a proximal end, and an intermediate surface oriented between the distal end and the proximal end. The protective layer is formed only on one of the distal end or the intermediate surface. A drug delivery device in which the protective layer is an anodized oxide, ceramic material, or polymer coating.

3. A drug delivery device, A distribution mechanism connected to a reservoir configured to contain a drug, A stainless steel needle connected to the distribution mechanism for delivering the drug, wherein the stainless steel needle has an outer surface for contacting a patient, and the stainless steel needle has a protective layer of a non-allergenic material covering at least a portion of the stainless steel needle to allow the stainless steel needle to be in direct contact with the patient. The stainless steel needle has a distal end, a proximal end, and an intermediate surface oriented between the distal end and the proximal end. A drug delivery device wherein the protective layer is a gold coating formed only on the distal end, spaced distally from the intermediate surface and spaced proximal from the proximal end.

4. A drug delivery device, A distribution mechanism connected to a reservoir configured to contain a drug, A stainless steel needle connected to the distribution mechanism for delivering the drug, wherein the stainless steel needle has an outer surface for contacting a patient, and the stainless steel needle has a protective layer of a non-allergenic material covering at least a portion of the stainless steel needle to allow the stainless steel needle to be in direct contact with the patient. The stainless steel needle has a distal end, a proximal end, and an intermediate surface oriented between the distal end and the proximal end. The protective layer is formed only on one of the distal end or the intermediate surface. The drug delivery device comprises a catheter, the stainless steel needle being an introduction needle positioned within the lumen of the catheter, with the distal end of the stainless steel needle extending from the catheter, and the distal end of the introduction needle being covered by a protective layer to avoid direct contact between the patient and the stainless steel needle.

5. The drug delivery device according to claim 1, wherein the delivery device is a pen needle having a needle hub having a proximal end configured to contact a delivery pen and a distal end supporting the needle.

6. A drug delivery device, A syringe comprising a syringe barrel having a proximal end, a distal end, and a lumen extending between the proximal and distal ends, and a stainless steel needle extending from the distal end, The stainless steel needle has a length for injecting drugs into a patient, and an outer surface covered with a protective layer of a non-allergenic coating material to avoid direct contact between the patient's tissue and the outer surface of the stainless steel needle, and to avoid allergic reactions in the patient due to contact with the stainless steel needle. The stainless steel needle has a distal end, a proximal end, and an intermediate surface oriented between the distal end and the proximal end. The protective layer is formed only on one of the distal end or the intermediate surface. A drug delivery device in which the protective layer is an anodized oxide, ceramic material, or polymer coating.

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