Subcutaneous infusion devices for injectable medications

Abstract

A subcutaneous infusion device for injecting a drug. A drug delivery device for delivering a drug into a user's body is provided. A foldable hub (18) has a left wing (20) and a right wing (22), wherein the hub is attached to a tube (16) at one end and to a needle (28) at an opposite end. At least one first rib (32) is provided on the left wing, and at least one second rib (34) is provided on the right wing. When the wings are folded back away from the needle and pinched together, the first and second ribs prevent the wings from twisting and / or sliding relative to each other during insertion of the needle into the user's skin, thereby preventing needle breakage due to undesired movement of the wings.

Description

[0001] This application is a divisional application of an invention patent application with an application date of March 25, 2015, application number 201580017380.2 (international application number PCT / US2015 / 022494), and invention name “Subcutaneous infusion device for injectable drugs”. Technical Field

[0002] The present disclosure relates generally to devices for injecting medications, and more particularly to a medical fluid delivery device for subcutaneously administering a viscous liquid medication into the body of a user. Background Art

[0003] Subcutaneous infusion devices are well known in the medical field and are used to administer a selected drug to a desired infusion site located beneath the skin of a patient or user. Such infusion devices often include a tubular cannula or catheter supported by and extending from a hub for receiving the drug via a delivery line. Typically, the hub includes a small needle that is inserted just below the surface of the skin and remains in place for several days.

[0004] More specifically, these infusion devices provide an alternative to static delivery of drugs and allow drugs to be administered through the skin layers just below the dermis and epidermis. As is well known in the art, such use of subcutaneous infusion devices reduces the number of injections a patient needs to receive frequently administered drugs. Although not all drugs can be administered through such infusion devices, they are an effective and convenient way to administer drugs without having to apply multiple injections to the patient.

[0005] However, some drugs are highly viscous (i.e., in the range of 3-10 cP or centipoise) and are delivered at high flow rates, and conventional subcutaneous infusion devices are not designed to deliver such highly viscous substances at such rates. Therefore, a buildup of excessive delivery pressure may occur during delivery of such substances, and blockages may occur in the needle or its immediate vicinity during infusion. In addition, because the needles used in delivery devices are typically bent about 90 degrees, the risk of kinking at or near the bend of the needle is relatively high.

[0006] Another problem with commonly used infusion sets is that movement of the hub can cause the needle to break during use. Foldable clamping wings are typically attached to the hub to hold the needle securely while inserting the needle directly into the desired infusion site at 90 degrees relative to the skin surface. Specifically, the wings are folded back from the needle and pinched together between two fingers. Sometimes, the folded wings slide against each other during the insertion step, making needle insertion quite challenging. In addition, if the needle is made with a smaller diameter, the needle will not be securely supported and cause the needle to break during use.

[0007] Therefore, there exists a need for improved subcutaneous infusion devices to facilitate more stable retention of the needle on the skin during the insertion step, as well as to reduce flow resistance of highly viscous materials during the delivery step. Summary of the invention

[0008] The present disclosure relates to a medical fluid delivery device for subcutaneously administering a viscous liquid drug into the body of a user or patient. The infusion device is designed to reduce the pressure drop (or flow resistance) that occurs during the delivery step of a viscous liquid or solution into the subcutaneous space of the user's skin. As described in more detail below, due to the geometry of the hub and needle, the infusion device delivers viscous liquids at a higher flow rate than conventional devices.

[0009] One aspect of the delivery device is to achieve low flow resistance during subcutaneous delivery of high viscosity liquids (e.g., 3-20 cP) within a flow range of from 40 to 400 ml / hr (or milliliters / hour). Specifically, a 24G (or gauge) needle with a thin tubular wall is provided to accommodate viscous liquids, and a middle region of the needle is slightly curved with a predetermined radius of curvature so that the middle region surrounds a support region located at the outer end of the hub.

[0010] Another important aspect is that the infusion device provides a secure placement of the needle, which reduces disturbances to the desired infusion site and enhances comfort during infusion. A plurality of substantially diagonally arranged ribs are provided on the bottom side of the hub for preventing undesired movement of the hub during wear by the user. More specifically, the diagonal bottom side ribs are angled in such a way that forward movement toward the needle tip is prevented while backward movement away from the needle tip is allowed. In addition, the diagonal pattern also stabilizes the hub against lateral disturbances after the needle is installed. This arrangement reduces shear and / or normal stresses on the needle bend.

[0011] Another aspect of the device is that the top side of the hub includes at least two ribs, one of which is located on the left and right wings of the hub, respectively. Each rib is asymmetrically arranged on the wing so that when the wings are folded back from the needle and pinched together, the two ribs prevent the wings from twisting and / or sliding relative to each other during insertion of the needle into the skin. Thus, the needle remains stable and straight during insertion, preventing breakage of the needle due to undesired movement of the wings. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 is a top perspective view of the infusion device, which features a winged hub with top side ribs;

[0013] Figure 2 is along Figure 1 A vertical cross-sectional view taken along the center line 2-2 and substantially in the indicated direction;

[0014] Figure 3 is a top view of the hub, which features the angled bottom side ribs;

[0015] Figure 4 is along Figure 3 A vertical cross-section taken along the center line 4-4 and generally in the indicated direction;

[0016] Figure 5 is a front view of the winged hub folded back from the needle in preparation for insertion of the needle into the infusion site;

[0017] Figure 6 is a perspective view of the infusion set being inserted into an infusion site;

[0018] Figure 7 is a perspective view of the infusion device during infusion; and

[0019] Figure 8 is an enlarged perspective view of the winged hub after the needle has been inserted into the infusion site. DETAILED DESCRIPTION

[0020] Now refer to Figure 1-2 , the subcutaneous infusion device is generally indicated at 10 and is designed to deliver drugs subcutaneously to the dermis and below the epidermis. Exemplary drugs may include nutritional products and herbal products. It is contemplated that the device 10 is disposable. The device 10 includes a Luer cap 12, which is configured to receive liquid at one end and is attached to a female Luer connector 14 at an opposite end using a threaded portion with a complementary spiral for threadably securing the cap and connector. In order to transport viscous liquid drugs to the infusion site, a flexible elongated tube 16 is attached to the female Luer connector 14 at one end and to a foldable hub 18 having a left wing or first wing 20 and a right wing or second wing 22 at an opposite end.

[0021] An exemplary length of the tube 16 is about 24 inches, but it is also contemplated that any tube length can be utilized to suit different applications. Adjusting the flow of the viscous liquid drug within the tube 16 is achieved by adjusting the sliding clamp 24 transversely relative to the longitudinal axis of the tube. As an example, a movable release slot 26 is provided in the middle of the sliding clamp 24, so that the clamp can be switched between an occluding position and a non-occluding position by selectively sliding the release slot relative to the tube 16.

[0022] In a preferred embodiment, the winged hub 18 is molded by injection molding or the like so that the hub and its connecting element are integrally formed. However, it is also contemplated that the hub 18 may be attached to the connecting element by chemical adhesives, solvent bonding, ultrasonic welding, or other commonly used fixing techniques. More specifically, the hub 18 is attached to the tube 16 at one end and to the needle 28 at the opposite end, and the needle 28 is slidably engaged to and protected by the needle protector 30 when not in use. It is contemplated that after the hub 18 is molded, the needle 28 is assembled to the hub 18 using an adhesive. Alternatively, the hub 18 may be over-molded on the needle 28.

[0023] An exemplary needle size is about 24G to ensure comfort during infusion, and an exemplary needle length may be one of 6, 9 or 12 mm (or millimeters) depending on the application. Preferably, needle 28 has a thin wall to accommodate viscous liquid medications.

[0024] An important aspect of the hub 18 is that each of the foldable left and right wings 20, 22 of the hub has at least one top rib 32, 34 extending along the entire longitudinal length of the respective wing. Each top rib 32, 34 is disposed on the upper surface 36 of the respective wing 20, 22 such that when the wings are folded, the top rib 32, 34 directly contacts the upper surface 36 of the corresponding opposing wing. Thus, the top rib 32 disposed on the left wing 20 engages the upper surface 36 of the right wing 22, and conversely, the top rib 34 disposed on the right wing 22 engages the upper surface 36 of the left wing 20.

[0025] As an example Figure 1 and 5 In the embodiment shown in FIG. 1 , the left or first top rib 32 is asymmetrically arranged with the right or second top rib 34 so that when the wings 20, 22 are folded back away from the needle 28 and pinched together ( Figure 5 ), the first top rib 32 is juxtaposed with the second top rib 34. More specifically, the first top rib 32 is parallel to the elongated middle portion 38 of the hub 18 and is spaced apart by a first predetermined distance D A ( Figure 1 ), and the second top rib 34 is parallel to the middle portion and spaced apart by a second predetermined distance D B ( Figure 1 ), where the first distance D A Different from the second distance D B .

[0026] For example, Figure 5 In the best shown embodiment, the first distance D A Longer than the second distance D B, and the first rib 32 runs over the second rib 34, so that the ribs 32, 34 are positioned close to each other when the wings 20, 22 are folded back. Therefore, this particular configuration of the top ribs 32, 34 prevents the wings 20, 22 from twisting or sliding relative to each other, thereby reducing the risk of needle 28 breaking during insertion of the needle into the skin.

[0027] Return now Figure 1-2 , a first insertion opening 40 at a first end of the intermediate portion 38 is configured to accommodate the insertion of the needle 28, and a second insertion opening 42 at a second opposite end of the intermediate portion in fluid communication with the tube 16 is configured to accommodate the insertion of the tube. In a preferred embodiment, the tube 16 is inserted into the first insertion opening 40 about half the length of the intermediate portion 38 to reduce the overall length of the needle 28 ( Figure 2 ).

[0028] The two openings 40, 42 provide a channel for liquid drug delivery. The channel provides low flow resistance for high viscosity liquids (e.g., 3-20 cP) during subcutaneous delivery within a flow range of 40 to 400 ml / hr without causing the fluid pressure to drop by more than 10 psi (or pounds per square inch). More specifically, the exemplary 24G sterile needle 28 with a thin wall is constructed to be suitable for the viscous liquid drug, and the middle region 44 of the needle 28 is slightly curved with a predetermined radius of curvature (e.g., typically 0.125", and not less than 0.060" or not more than 0.200"), so that the middle region of the needle surrounds a support region 46 located at or near the first insertion opening 40 of the middle portion 38.

[0029] Preferably, the middle region 44 of the needle 28 is gradually curved at an angle of 45 to 90 degrees (nominally close to 90 degrees) so that the support region 46 supports the curved middle region of the needle. The tip of the needle 28 extends outward from the first insertion opening 40 of the middle portion 38 so that the tip of the needle is arranged transverse to the longitudinal axis of the middle portion. Therefore, the support region 46 reduces the risk of needle damage and provides overall support for the curved middle region 44 not only during insertion of the needle 28 into the skin, but also when attached to the user's body.

[0030] Now refer to Figure 2-48, a plurality of substantially diagonally arranged bottom ribs 48a, 48b are provided on the lower or bottom surface 50 of each wing 20, 22 for preventing undesired movement of the hub 18 during use. Preferably, the bottom ribs 48a, 48b are substantially evenly spaced in parallel and extend along the entire diagonal length of the corresponding wing 20, 22. The bottom ribs 48a, 48b are angled or inclined in such a manner as to prevent forward movement toward the tip of the needle 28 while allowing rearward movement away from the tip of the needle. This particular arrangement reduces shear and / or normal stresses on the curved intermediate region 44 of the needle 28 during use.

[0031] In a preferred embodiment, both the first and second wings 20, 22 of the hub 18 have bottom ribs 48a, 48b that are positioned on the lower surface 50 at an angle of approximately 45 degrees relative to the longitudinal axis of the middle portion 38. However, an important aspect of the ribs 48a, 48b is that each bottom rib 48a disposed on the lower surface 50 of the first wing 20 slopes or angles upward from the left side of the first wing toward the middle portion 38 to the right side of the first wing. In a mirror image direction, each bottom rib 48b disposed on the lower surface 50 of the second wing 22 slopes or angles downward from the left side of the second wing proximate the middle portion 38 to the right side of the second wing. Overall, the bottom ribs 48a, 48b are constructed and arranged in a herringbone or herringbone pattern, thereby preventing undesired movement of the hub 18 during attachment to the user's body.

[0032] The enhanced friction provided by the ribs 48a, 48b prevents the hub 18 from sliding away from the skin during use. While the diagonally arranged ribs 48a, 48b are shown for illustrative purposes, any type of knurled or textured ribs, ridges, grooves or blocks are envisioned for deployment as friction formations on the lower surface 50 of the wings 20, 22 to enhance friction in this manner. In addition, the angular orientation and / or spacing of the ribs 48a, 48b may be varied to suit the situation.

[0033] Now refer to Figure 5-7 , illustrates an exemplary use of the infusion device in more detail. Before inserting the needle 28 into the skin, the user folds the wings 20, 22 back away from the needle 28 and pinches the wings between two fingers. The user then subsequently removes the needle protector 30 from the needle 28 and discards the protector ( Figure 5 In preparation for insertion, the user pinches one inch of clean skin at the desired infusion site and inserts the needle 28 in a throwing motion at a 90 degree angle ( Figure 6) is inserted directly into the infusion site. Next, the user checks the positioning of the needle and syringe 52 by pulling back on the plunger 54. If blood is observed in the syringe 52, the device 10 is removed and discarded if a disposable device is used. Otherwise, the user repeats the process of preparing the device 10 and the infusion site. When no blood is observed in the syringe 52, the user secures the needle 28 in place and begins the infusion under the guidance of the medical care professional.

[0034] While particular embodiments of the infusion device have been shown and described, it will be appreciated by those skilled in the art that changes and modifications may be made to the invention without departing from the disclosure in its broader aspects and as set forth in the claims.

Claims

1. A subcutaneous infusion device, comprising: a foldable hub having left and right wings, the hub being configured to receive a tube at a first end, wherein a lower surface of each of the left and right wings is configured to be placed in contact with the skin of a user; a support region disposed at a second end of the hub opposite the first end; as well as a needle attached to the hub, the needle configured for insertion into the skin of a user, wherein the needle comprises a first portion and a second portion, wherein the first portion and the second portion are connected by a middle region of the needle; wherein the middle region of the needle and the support region of the hub are curved at the same predetermined radius of curvature along an interface where the support region is in supporting contact with the middle region, so that the middle region surrounds and is supported by the support region to reduce the risk of needle breakage during insertion of the needle into the skin of a user; The middle region of the needle is bent at an angle of 45 to 90 degrees, so that the supporting region supports the bent middle region of the needle.

2. An infusion device as described in claim 1, wherein the second portion of the needle includes a tip of the needle, which extends outward from the middle region of the needle so that the tip of the needle is arranged transverse to the longitudinal axis of the hub.

3. An infusion device as described in claim 2, wherein the tip is perpendicular to the longitudinal axis of the hub, and wherein the second portion is straight.

4. The infusion device of claim 1, wherein a lower surface of each of the left and right wings comprises ribs configured to be placed in contact with the user's skin to prevent undesired movement of the hub during use.

5. The infusion device of claim 1, wherein the hub terminates at the first portion of the needle.

6. An infusion device as described in claim 1, wherein the hub is configured to receive the tube approximately halfway into the longitudinal length of the middle portion of the hub, wherein the hub includes the middle portion and the support area.

7. The infusion device of claim 1, wherein the needle extends through the second end of the hub.

8. A subcutaneous infusion device comprising: a foldable hub having a left wing and a right wing, the hub being configured to receive a tube at a first end; a support region disposed at a second end of the hub opposite the first end; as well as a needle attached to the hub, the needle configured for insertion into the skin of a user, wherein the needle comprises a first portion and a second portion, the second portion comprising a tip of the needle, wherein the first portion and the second portion are connected by a middle region of the needle; wherein the middle region of the needle and the support region of the hub are curved at the same predetermined radius of curvature along an interface where the support region is in supporting contact with the middle region, so that the middle region surrounds and is supported by the support region to reduce the risk of needle breakage during insertion of the needle into the skin of a user, and wherein the hub terminates at a second portion of the needle; The middle region of the needle is bent at an angle of 45 to 90 degrees, so that the supporting region supports the bent middle region of the needle.

9. The infusion device of claim 8, wherein the second portion of the needle comprises a tip of the needle extending outwardly from a middle region of the needle such that the tip of the needle is arranged transversely to the longitudinal axis of the hub.

10. The infusion device of claim 9, wherein the tip is perpendicular to the longitudinal axis of the hub, and wherein the second portion is straight.

11. The infusion device of claim 8, wherein a lower surface of each of the left and right wings includes ribs configured to be placed in contact with the user's skin to prevent undesired movement of the hub during use.

12. An infusion device as described in claim 8, wherein the hub is configured to receive the tube approximately halfway into the longitudinal length of the middle portion of the hub, wherein the hub includes the middle portion and the support area.

13. A subcutaneous infusion device comprising: A foldable hub, the foldable hub comprising: The middle part, left and right; and a support region disposed at a second end of the hub opposite the first end of the hub; a tube inserted into the first end of the hub approximately halfway into the longitudinal length of the intermediate portion; and a needle attached to the hub, the needle configured for insertion into the skin of a user, wherein the needle comprises a first portion and a second portion, wherein the first portion and the second portion are connected by a middle region of the needle; wherein the middle region of the needle and the support region of the hub are curved at the same predetermined radius of curvature along an interface where the support region is in supporting contact with the middle region, so that the middle region surrounds and is supported by the support region to reduce the risk of needle breakage during insertion of the needle into the skin of a user; The middle region of the needle is bent at an angle of 45 to 90 degrees, so that the supporting region supports the bent middle region of the needle.

14. The infusion device of claim 13, wherein the second portion of the needle comprises a tip of the needle extending outwardly from a middle region of the needle such that the tip of the needle is arranged transverse to a longitudinal axis of the hub.

15. The infusion device of claim 14, wherein the tip is perpendicular to the longitudinal axis of the hub, and wherein the second portion is straight.

16. The infusion device of claim 13, wherein a lower surface of each of the left and right wings includes ribs configured to be placed in contact with the user's skin to prevent undesired movement of the hub during use.

17. The infusion device of claim 13, wherein the first portion and the middle region of the needle have a longitudinal length that is approximately half of the middle portion.

18. The infusion set of claim 13, wherein the first end comprises a first insertion opening to accommodate the tube, and wherein the second end comprises a second insertion opening to accommodate the first portion of the needle.

19. A medical delivery device for delivering a drug into a user's body, comprising: a foldable hub (18) having a left wing (20) and a right wing (22), the hub being attached to the tube (16) at one end and to a needle (28) at an opposite end, the needle being configured for insertion into the skin of a user, the needle having a first portion and a second portion, the first portion being coaxial with the longitudinal axis of the tube and the second portion being curved relative to the longitudinal axis of the tube, wherein the second portion and a support area (46) of the hub are curved at the same predetermined radius of curvature along an interface where the support area is in supporting contact with the second portion, such that the second portion surrounds and is supported by the support area (46) to reduce the risk of needle breakage during insertion of the needle into the skin of the user; wherein at least one first rib (32) is disposed on the left wing and at least one second rib (34) is disposed on the right wing, such that when the wings are folded back away from the needle and pinched together, the first and second ribs prevent twisting and / or sliding of the wings relative to each other during insertion of the needle into the skin of a user, thereby preventing damage to the needle due to undesired movement of the wings; and wherein the first rib is spaced parallel to the longitudinal axis of the tube by a first distance, and the second rib is spaced parallel to the longitudinal axis of the tube by a second distance, the first distance being different from the second distance; The second portion of the needle is bent at an angle of 45 to 90 degrees, so that the support area supports the bent second portion of the needle.

20. The medical delivery device of claim 19, wherein the at least one first and second rib (32, 34) extends along the entire longitudinal length of the respective wing (20, 22).

21. The medical delivery device of claim 19, wherein each of the at least one first and second ribs (32, 34) is arranged on an upper surface (36) of a corresponding wing (20, 22) such that when the wings are folded, the at least one first and second ribs directly contact the upper surface of the corresponding opposing wing.

22. The medical delivery device of claim 19, wherein the at least one first rib (32) and the at least one second rib (34) are asymmetrically arranged such that when the wings are folded back away from the needle and pinched together, the at least one first rib is juxtaposed with the at least one second rib.

23. A medical delivery device as described in claim 19, wherein a first insertion opening (40) at a first end of the intermediate portion (38) of the hub is configured to accommodate insertion of a needle (28), and a second insertion opening (42) at a second opposite end of the intermediate portion that is fluidly connected to the tube (16) is configured to accommodate insertion of the tube.

24. The medical delivery device of claim 23, wherein the tube (16) is inserted into the first insertion opening (40) approximately half the length of the intermediate portion (38) to reduce the overall length of the needle.

25. The medical delivery device of claim 19, further comprising a Luer cap (12) configured to receive a substance at one end and to attach to a female Luer connector (14) at an opposite end.

26. The medical delivery device of claim 19, further comprising: A flexible, elongated tube (16) attached at one end to a female Luer connector (14) and at an opposite end to the foldable hub (18); and a sliding clamp (24) configured to adjust the flow of material within the tube by adjusting the clamp transversely relative to the longitudinal axis of the tube.

27. The medical delivery device of claim 19, wherein the needle has a straight third portion including a tip, the tip being transverse to the longitudinal axis of the tube.

28. The medical delivery device of claim 19, further comprising a plurality of ribs (48) on a lower surface (50) of each wing.

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