# Patent

## Title
Device for insertion of a cannula of an infusion device and method

## Abstract

A device for inserting a needle used to introduce a cannula can include a housing including a closed end, an open end, and an arm including a tab extending from the open end, and a sleeve configured to be placed against the patient's skin, the sleeve defining a slot extending along a length of the sleeve, and a barb positioned adjacent to an end of the slot. The slot is sized to receive at least a portion of the arm and the tab of the housing so that the arm and the tab of the housing slides within the slot as the housing is moved relative to the sleeve, and the barb is positioned to engage the tab of the housing to limit movement of the housing relative to the sleeve. The device can also include a threaded portion of the housing extending towards the closed end of the housing.

## Background
RELATED APPLICATIONS
This application is a division of application Ser. No. 12/844,402 filed Jul. 27, 2010, which claims the benefit of U.S. Provisional Application No. 61/229,466 filed Jul. 29, 2009, each of which is hereby fully incorporated herein by reference.


BACKGROUND
Infusion devices are used to deliver substances such as medications into the subcutaneous layer of skin of a patient. Devices for assisting in insertion of the cannula of an infusion device into the skin of the patient are known. For example, some devices utilize springs to automatically drive a needle into the skin of a patient to introduce the cannula of the infusion device into the subcutaneous layer.
Because a needle is used to introduce the cannula of the infusion device into the subcutaneous layer of skin, there is a risk associated with inadvertent exposure to the needle. Further, patients may react adversely to viewing the needle prior to insertion and may, for example, be reluctant to place the needle into the skin. Prior devices may not adequately shroud this needle prior to and/or after introduction of the infusion device.
Other issues of concern in the design and use of insertion devices include ease of use by the patient and sterilization. For example, some patients may have difficulty loading the infusion device into the insertion device.
SUMMARY
In one aspect, a device for inserting a needle used to introduce a cannula of a subcutaneous infusion device into a subcutaneous layer of skin of a patient includes: a housing including a closed end, an open end, and an arm including a tab extending from the open end; and a sleeve configured to be placed against the patient's skin to introduce the cannula into the patient's skin, the sleeve defining a slot extending along a length of the sleeve, and a barb positioned adjacent to an end of the slot; wherein the slot is sized to receive at least a portion of the arm and the tab of the housing so that the arm and the tab of the housing slides within the slot as the housing is moved relative to the sleeve; and wherein the barb is positioned to engage the tab of the housing to limit movement of the housing relative to the sleeve.
In another aspect, a device for inserting a needle used to introduce a cannula of a subcutaneous infusion device into a subcutaneous layer of skin of a patient includes: a housing including a closed end, an open end, and defining an internal cavity, the housing including a threaded portion positioned adjacent to the open end, the threaded portion extending towards the closed end of the housing; the needle positioned within the internal cavity of the housing and coupled to the cannula of the subcutaneous infusion device; a cap including a cap closed end and a cap open end, the cap including a cap threaded portion positioned adjacent to the open end; wherein the cap threaded portion is coupled to the threaded portion of the housing with the device in a ship state.
In another aspect, a method for inserting a needle used to introduce a cannula of a subcutaneous infusion device into a subcutaneous layer of skin of a patient includes: positioning a tab of a housing in a slot formed by a sleeve of a device; positioning the sleeve against the patient's skin; moving the housing relative to the sleeve to introduce the cannula into the patient's skin; and allowing the tab to slide within the slot as the housing is moved relative to the sleeve.



DESCRIPTION OF THE FIGURES
FIG. 1 is a perspective view of an example embodiment of a device used to introduce a cannula of an infusion device into a patient.
FIG. 2 is a side view of the device of FIG. 1.
FIG. 3 is a cross-sectional view taken along line A-A of the device of FIG. 2.
FIG. 4 is a perspective view of the device of FIG. 1 with a cap removed.
FIG. 5 is a side view of the device of FIG. 4.
FIG. 6 is a cross-sectional view taken along line B-B of the device of FIG. 5.
FIG. 7 is a perspective view of the device of FIG. 3 in a trigger state.
FIG. 8 is a side view of the device of FIG. 7.
FIG. 9 is a cross-sectional view taken along line C-C of the device of FIG. 8.
FIG. 10 is an exploded view of the device of FIG. 1.
FIG. 11 is a perspective view of an example housing of the device of FIG. 1.
FIG. 12 is another perspective view of the housing of FIG. 11.
FIG. 13 is a side view of the housing of FIG. 11.
FIG. 14 is a perspective view of an example sleeve of the device of FIG. 1.
FIG. 15 is another perspective view of the sleeve of FIG. 14.
FIG. 16 is a side view of the sleeve of FIG. 14.
FIG. 17 is an end view of the sleeve of FIG. 14.
FIG. 18 is a perspective view of another example embodiment of a device used to introduce a cannula of an infusion device into a patient.
FIG. 19 is a side view of the device of FIG. 18.
FIG. 20 is a cross-sectional view taken along line D-D of the device of FIG. 19.
FIG. 21 is a perspective view of the device of FIG. 18 with a cap removed.



DETAILED DESCRIPTION
A first embodiment of a device 100 is shown in FIGS. 1-17. As shown in FIG. 10, the device 100 includes a housing 10, a needle hub 1, a cylinder hub 2, a spring 3, a sleeve 15, a site 6 including a septum 5, a holder 4, and an adhesive layer 7, and a removable cap 20.
Generally, the device 100 is used to introduce a cannula 50 associated with the site 6 into the skin of a patient. The site 6 is then disconnected from the device 100, and the site 6 remains on the skin to deliver substances to the patient.
The housing 10 is preferably cylindrical in shape and includes a closed upper end and an open lower end. The housing 10 further preferably includes a knurled exterior surface to enhance a patient's grip on the housing 10, as well as a threaded portion 11 positioned to engage the cap 20, as described further below. The housing 10 includes an internal cavity sized to receive at least a portion of the needle hub 1 and the cylinder hub 2.
The needle hub 1 includes a main body 201 and a needle 202 (hollow or solid) coupled to the main body 201. The needle hub 1 is positioned in the interior passage of the cylinder hub 2 in a fixed position relative to the cylinder hub 2 and the housing 10. See, for example, FIGS. 3, 6, 9.
The cylinder hub 2 is coupled to the upper end of the housing 10. The cylinder hub 2 includes the interior passage into which the needle hub 1 is positioned. As described further below, the needle hub 1 moves longitudinally within the passage formed by the cylinder hub 2.
The spring 3 surrounds a portion of the cylinder hub 2. One end of the spring 3 is seated on the sleeve 15, and the other end of the spring 3 engages the needle hub 1. The spring 3 is in a compressed state as shown in FIGS. 3 and 6 and therefore applies force against the needle hub 1, biasing the needle hub 1 in an upward direction towards the closed end of the housing 10. Likewise, the spring 3 forces the housing 10 and the sleeve 15 apart. Further, as the housing 10 and associated needle hub 1 are moved relative to the sleeve 15, the spring 3 is further compressed until the needle hub 1 is released from the cylinder hub 2, as described below. At that point, the spring 3 forces the needle hub 1 back upward into the housing 10.
The sleeve 15 is preferably cylindrical in shape. The sleeve 15 is coupled to the housing 10 such that the housing 10 can be moved longitudinally with respect to the sleeve 15, as described herein.
The site 6 is loaded into the device 100 prior to application of the adhesive layer 7 onto the device 100. The adhesive layer 7 is pierced by the needle 202 as the needle 202 is advanced towards the skin, as described further below. The adhesive layer 7 maintains the site 6 on the skin of the patient. The site 6 includes the septum 5 that is piercable by a needle of a set configured to deliver medication into the septum 5, through the cannula 50, and into the patient. The holder 4 maintains the septum 5 in position within the site 6.
The cap 20 includes a closed end and an open end. The cap 20 preferably includes an exterior with a knurled surface to enhance the patient's grip on the cap 20. In addition, the interior of the cap 20 includes a threaded portion 21 positioned adjacent the open end so that the threaded portion 21 can be threaded onto the threaded portion 11 of the housing 10 to seal the device 100. See FIGS. 1-3.
As shown in FIGS. 1-9, the device 100 includes a ship state (FIGS. 1-3), a delivery state (FIGS. 4-6), and a trigger state (FIGS. 7-9).
In the ship state shown in FIG. 1-3, the device 100 includes the site 6 in a state such that the site 6 is ready for deployment by the patient after the cap 20 is removed.
In the delivery state shown in FIG. 4-6, the cap 20 has been unscrewed to remove the cap 20 from the device 100. The patient then places an end 23 of the sleeve 15 against the patient's skin at the desired location. In this state, the patient can insert the cannula 50 of the site 6 into the patient's skin. To accomplish this, the needle hub 1 includes the needle 202 that extends through the cannula 50 of the site 6 by depressing the housing 10 to move the needle hub 1 that is coupled thereto so that the needle 202 and associated cannula 50 of the site 6 are introduced into the skin.
In the trigger state shown in FIG. 7-9, the housing 10 has been moved towards the skin until the cannula 50 is fully inserted and the housing 10 has moved adjacent to the sleeve 15. At this state, the spring 3 of the device 100 moves the needle hub up into the housing 10, so that the needle is removed from the skin while leaving the cannula 50 of the site 6 in the skin.
The device 100 can then be removed from the skin and discarded.
As shown in FIGS. 11-13, the housing 10 has three tabs 200 that extend from arms 206 of the housing 10 that engage complementary slots 210 formed along lengths of the sleeve 15 (see FIGS. 14-17) to couple the housing 10 to the sleeve 15. The tabs 200 maintain the connection between the housing 10 and the sleeve 15 while allowing the housing 10 to slide relative to the sleeve 15 in the slots 210 during insertion of the needle and cannula 50 of the site 6 into the skin. At the upper end of each of the slots 210, a barb 212 is formed so that each respective tab 200 engages the barb 212 as the tab 200 slides within the slot 210 to maintain the tab 200 within the slot. See FIGS. 3 and 6.
In addition, in some embodiments, the sleeve 15 includes one or more rails 234 (see FIGS. 14 and 17) that run parallel to the centerline of the sleeve 15 and are positioned adjacent to the slots 210. The rails 234 align with corresponding grooves 232 in the housing 10 (see FIGS. 11-13), so that the rails 234 slide within the grooves 232 during insertion of the needle and cannula 50 of the site 6 into the skin. The engagement of the rails 234 with the grooves 232 maintains the orientation of the housing 10 relative to the sleeve 15 as the housing 10 is slid relative to the sleeve 15 during insertion of the cannula 50. In the example shown, the rails 234 are provided in pairs adjacent to the edges of the slots 210. Other configurations are possible.
Referring now to FIGS. 18-21, another device 300 is shown. The device 300 is similar to the device 100 described above. However, the device 300 includes a housing 302 with a threaded portion 310 that is positioned external from the housing 302 and extends towards a closed end 322 of the housing and away from the sleeve 306, rather than towards the sleeve 306 as shown in the previous embodiment. See FIGS. 20 and 21. In addition, a cap 304 includes an extended portion 320 positioned to be screwed onto the threaded portion 310 of the housing 302.
Additional details regarding some of the components of the devices described herein can be found in U.S. patent application Ser. No. 10/705,719 filed Nov. 10, 2003 and granted as U.S. Pat. No. 7,731,691 on Jun. 8, 2010, the entirety of which is hereby incorporated by reference.
Modifications, permutations, or subsets can be made to the examples described herein without departing from the scope and spirit of the designs.

## Claims

1. A method for inserting a needle used to introduce a cannula of a subcutaneous infusion device into a subcutaneous layer of skin of a patient, the method comprising:
positioning a tab of a housing in a slot formed by a sleeve of a device;
positioning the sleeve against the patient's skin;
positioning a rail of the sleeve: into a groove of the housing, the rail extending parallel to a centerline of the sleeve and projecting inwardly from the sleeve, wherein the rail and the slot are immediately adjacent one another on a same surface of the sleeve;
moving the housing relative to the sleeve to introduce the cannula into the patient's skin; and
allowing the tab to slide within the slot, and allowing the rail to slide within the groove, as the housing is moved relative to the sleeve.

2. The method of claim 1, further comprising threading a cap onto the housing, the cap including a cap closed end and a cap open end, the cap including a cap threaded portion positioned adjacent to at open end, and the cap threaded portion being coupled to a threaded portion of the housing with the device in a ship state.

3. The method of claim 1, wherein the sleeve comprises a continuous surface, and wherein the rail and the slot are immediately adjacent one another on the same continuous surface.

4. The method of claim 1, wherein the slot extends along an entire axial length of the sleeve.

5. The method of claim 1, wherein the rail and the groove are configured to be in contact with each other as the housing is moved relative to the sleeve.

6. The method of claim 1, wherein the rail includes an axial length, and wherein the rail both extends parallel to a centerline of the sleeve and projects inwardly from the sleeve along the entirety of the axial length of the rail.

7. The method of claim 1, wherein the rail and the groove are configured such that the rail engages the groove as the housing is moved relative to the sleeve, so as to maintain an orientation of the housing relative to the sleeve.

8. A method for inserting a needle used to introduce a cannula of a subcutaneous infusion device into a subcutaneous layer of skin of a patient, the method comprising:
positioning tab of a housing in a slot formed by a sleeve of a device, wherein the slot extends along an entire axial length of the sleeve;
positioning the sleeve against the patient's skin;
positioning a rail of the sleeve into a groove of the housing, the rail extending parallel to a centerline of the sleeve and projecting inwardly from the sleeve;
moving the housing relative to the sleeve to introduce the cannula into the patient's skin; and
allowing the tab to slide within the slot, and allowing the rail to slide within the groove, as the housing is moved relative to the sleeve.

9. The method of claim 8, wherein the rail and the slot are on a same surface of the sleeve.

10. The method of claim 9, wherein the sleeve comprises a continuous surface, and wherein the rail and the slot are immediately adjacent one another on the same continuous surface.

11. The method of claim 8, wherein the rail and the groove are configured to be in contact with each other as the housing is moved relative to the sleeve.

12. The method of claim 8, wherein the rail includes an axial length, and wherein the rail both extends parallel to a centerline of the sleeve and projects inwardly from the sleeve along the entirety of the axial length of the rail.

13. The method of claim 8, wherein the rail and the groove are configured such that the rail engages the groove as the housing is moved relative to the sleeve, so as to maintain an orientation of the housing relative to the sleeve.

14. A method for inserting a needle used to introduce a cannula of a subcutaneous infusion device into a subcutaneous layer of skin of a patient, the method comprising:
positioning a tab of a housing in at slot formed by a sleeve of a device;
positioning the sleeve against the patient's skin;
positioning a rail of the sleeve into a groove of the housing, the rail extending parallel to a centerline of the sleeve and projecting inwardly from the sleeve, wherein the rail includes an axial length, and wherein the rail both extends parallel to a centerline of the sleeve and projects inwardly from the sleeve along the entirety of the axial length of the rail;
moving the housing relative to the sleeve to introduce the cannula into the patients skin; and
allowing the tab to slide within the slot, and allowing the rail to slide within the groove, as the housing is moved relative to the sleeve.

15. The method of claim 14, wherein the rail and the slot are on a same surface of the sleeve.

16. The method of claim 15, wherein the rail and the slot are immediately adjacent one another on a same surface of the sleeve.

17. The method of claim 15, wherein the Sleeve comprises a continuous surface, and wherein the rail and the slot are immediately adjacent one another on the same continuous surface.

18. The method of claim 15, wherein the rail and the groove are configured to be in contact with each other as the housing is moved relative to the sleeve.

19. The method of claim 15, wherein the rail and the groove are configured such that the rail engages the groove as the housing is moved relative to the sleeve, so as to maintain the Orientation of the housing relative to the sleeve.