Needle insertion systems and methods

• US 9,364,612 B2
• Filed: 11/17/2010
• Issued: 06/14/2016
• Est. Priority Date: 12/16/2008
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Hanson, Ian B., Kavazov, Julian D.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Carpenter, William
• Application Number:
  US12/948,326
• Publication Number:
  US 20110066012A1
• Time in Patent Office: 2,036 Days
• Field of Search: 604/164.01, 604/164.04, 604/164.07, 604/164.08, 604/164.12, 604/165.01, 604/165.02
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1426 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2205/58 Means for facilitating use, e.g. by people with impaired vision
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/585 having magnification means, e.g. magnifying glasses
• CPC Class Codes: A61M 2205/586 Ergonomic details therefor, e.g. specific ergonomics for left or right-handed users
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A housing may have a needle, plunger, and bias mechanism supported within the housing by a tab configured to retain the plunger in position and to allow the plunger to move under bias force imparted by the bias mechanism to move the needle to an insert position when the tab is removed. A base and a structure may be configured for relative movement there between and may be adapted to be secured to a user with a cannula extending through a body of the structure into the user during use of a medical device. A housing may be adapted to be secured to a user to support a medical device operable with an insertion needle, the housing having a magnifying material for increasing visibility of an injection site.

Claims

1. A medical device, the device comprising:

a medical monitoring or treatment device configured to provide a monitoring or treatment operation on a user;

a base adapted to be secured to the user, in contact with clothing or skin of the user during operation of the medical monitoring or treatment device, the base having an internal area;

a cannula housing structure adapted to be secured to the user, the cannula housing further adapted to be in contact with clothing or skin of the user during operation of the medical monitoring or treatment device, the cannula housing structure is located within the internal area of the base, the cannula housing structure connected to an supported by the base, the cannula housing structure having a body, the cannula housing structure and the base configured for relative movement therebetween, the cannula housing structure arranged to be separate and apart from the base;

a cannula extending through the body of the cannula housing structure during operation of the medical monitoring or treatment device, the cannula for inserting into the skin of the user for operation of the medical monitoring or treatment device;

a flexible connection connecting the base and the cannula housing structure for allowing relative movement between the cannula housing structure and the base while the cannula housing structure is located within the internal area of the base, after the cannula is inserted into the skin of the user and during operation of the medical monitoring or treatment device;

a first adhesive material provided on at least a portion of the cannula housing structure, the first adhesive material having an adhesion strength for adhering the cannula housing to the clothing or skin of the user; and

a second adhesive material provided on at least a portion of the base, the second adhesive material having an adhesion strength for adhering the base to the clothing or skin of the user;

wherein the cannula housing structure is supported within the internal area of the base and the internal area of the base includes a space around the cannula housing structure for allowing relative movement in an axial direction and a lateral direction between the cannula housing structure and the base, while the cannula is in the skin of the user, and while the base is adhered to the clothing or skin of the user, and

wherein the flexible connection connecting the base and the cannula housing structure is configured to allow relative movement between the cannula housing structure and the base while the cannula is locked in an extended state when the cannula is in the skin of the user for operation of the medical monitoring or treatment device.

2. The medical device of claim 1,

wherein at least one of the base, the cannula housing structure, and the cannula is placeable by an insertion device.

3. The medical device of claim 1,

wherein the flexible connection comprises a living hinge connecting the base and the cannula housing structure.

4. The medical device of claim 1, the device further comprising:

a bias member provided between the base and the cannula housing structure.

5. The medical device of claim 1, the device further comprising:

a fluid connection in fluid communication with the cannula and a reservoir containing fluidic media, the fluid connection being separate from the flexible connection.

6. The medical device of claim 5, wherein the fluid connection comprises a flexible tubing.

7. The medical device of claim 1, the device further comprising:

a housing, the base, and the cannula housing structure adapted to fit within the housing.

8. The medical device of claim 1,

wherein the base has a base surface facing skin of the user during operation of the medical monitoring or treatment device;

wherein the base has an opening through the base surface;

wherein the internal area of the base includes the opening;

wherein the cannula housing structure is supported at least partially within the opening; and

wherein the opening includes a space between the cannula housing structure and the base for allowing lateral movement between the cannula housing structure relative and the base while the cannula housing structure is supported at least partially within the opening and the cannula is in the skin of the user.

9. The medical device of claim 8,

wherein the first adhesive material and the second adhesive material have different adhesion strengths.

10. The medical device of claim 1,

wherein the first adhesive material is provided on at least a first portion of the cannula housing structure and at least a second portion of the cannula housing structure for securing the structure to the user, the first adhesive material having a different adhesion strength on the first portion that on the second portion.

11. The medical device of claim 1,

wherein the second adhesive material is provided on at least a first portion of the base and at least a second portion of the base for securing the base to the user, the second adhesive material having a different adhesion strength on the first portion than on the second portion.

12. The medical device of claim 11, wherein at least one of the base, the cannula housing structure, and the cannula is placeable by an insertion device.

13. The medical device of claim 1, wherein the cannula housing structure comprises a sensor for sensing a parameter of the user during operation of the medical monitoring or treatment device.

14. The medical device of claim 1, the device further comprising:

a sensor for sensing a parameter of the user during operation of the medical monitoring or treatment device, the sensor operatively connected to and supported by the cannula housing structure.

15. The medical device of claim 1,

wherein the flexible connection is configured to maintain the connection of the cannula housing structure and the base for relative movement between the cannula housing structure and the base while the cannula housing structure is located within the internal area of the base, when the cannula housing structure and the base are both secured to the user by the first and second adhesive materials and while the medical monitoring or treatment device operates on the user.

16. The medical device of claim 15, wherein the first adhesive material has a different adhesion strength than the second adhesive material.

17. The medical device of claim 15, wherein the medical monitoring or treatment device comprises a device that conveys fluid relative to the user, through the cannula, as at least part of the monitoring or treatment operation on a user when the cannula is inserted into the skin of the user and the cannula housing structure and the base are both secured to the user by the first and second adhesive materials.

18. The medical device of claim 1, wherein the medical monitoring or treatment device comprises a device that conveys fluid relative to the user, through the cannula when the cannula is inserted into the skin of the user, as at least part of the monitoring or treatment operation on a user.

19. A method of making a medical device, the method comprising:

providing a medical monitoring or treatment device configured to provide a monitoring or treatment operation on a user;

providing a base adapted to be secured to the user, in contact with clothing or skin of the user during operation of the medical monitoring or treatment device, the base having an internal area;

providing a cannula housing structure within the internal area of the base, the cannula housing structure adapted to be secured to the user, the cannula housing structure further adapted to be in contact with clothing or skin of the user during operation of the medical monitoring or treatment device, the cannula housing structure having a body, the cannula housing structure arranged to be separate and apart from the base;

providing a cannula extending through the body of the cannula housing structure during operation of the medical monitoring or treatment device, the cannula for inserting into the user for operation of the medical monitoring or treatment device;

connecting and supporting the cannula housing structure with the base by a flexible connection that allows relative movement between the cannula housing structure and the base while the cannula housing structure is located within the internal area of the base, after the cannula is inserted into the skin of the user and during operation of the medical monitoring or treatment device;

providing a first adhesive material on at least a portion of the cannula housing structure, the first adhesive material having an adhesion strength for adhering the cannula housing to the clothing or the skin of the user; and

providing a second adhesive material on at least a portion of the base, the second adhesive material having an adhesion strength for adhering the cannula housing to the clothing or the skin of the user;

wherein the cannula housing structure is supported within the internal area of the base and the internal area of the base includes a space around the cannula housing structure for allowing relative movement in an axial direction and a lateral direction between the cannula housing structure and the base, while the cannula is in the skin of the user, and while the base is adhered to the clothing or skin of the user, and

wherein the flexible connection connecting the base and the cannula housing structure is configured to allow relative movement between the cannula housing structure and the base while the cannula is locked in an extended state when the cannula is in the skin of the user for operation of the medical monitoring or treatment device.

20. The method of claim 19, wherein:

providing the base comprises providing the base with an opening, the internal area of the base is located within the opening, and

providing the cannula housing structure comprises locating the cannula housing structure at least partially within the opening and separated from the base by a space between the base and the cannula housing structure to allow the relative movement of the base and the cannula housing structure to occur in an axial direction and a lateral direction while the cannula housing structure is located within the internal area of the base and while the cannula is in the skin of the user.

21. The method of claim 19, further comprising providing a fluid connection for fluid flow between the medical monitoring or treatment device and the cannula, the fluid connection being separate from the flexible connection.