Anchoring apparatus and method for attaching device on body

• US 10,194,864 B2
• Filed: 06/21/2013
• Issued: 02/05/2019
• Est. Priority Date: 06/21/2013
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Chattaraj, Sarnath, Dang, Kiem, Gulati, Poonam S., Shallenberger, James
• Primary Examiner(s): Cheng, Jacqueline
• Assistant Examiner(s): PORTILLO, JAIRO H
• Application Number:
  US13/924,038
• Publication Number:
  US 20140378799A1
• Time in Patent Office: 2,055 Days
• Field of Search: None
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: B32B 2255/10 on synthetic resin layer or on natural or synthetic rubber layer
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses or catheter
• CPC Class Codes: B32B 3/02 characterised by features of form at particular places, e.g. in edge regions non-uniform thickness B32B3/263
• CPC Class Codes: B32B 3/06 for securing layers together; for attaching the product to another member, e.g. to a support , or to another product, e.g. groove/tongue, interlocking
• CPC Class Codes: B32B 5/022 Non-woven fabric
• CPC Class Codes: B32B 5/06 characterised by a fibrous or filamentary layer mechanically connected, e.g. by needling to another layer, e.g. of fibres, of paper
• CPC Class Codes: B32B 5/26 another layer next to it also being fibrous or filamentary relative arrangement of fibres or filaments of different layers B32B5/12
• CPC Class Codes: B32B 7/12 using interposed adhesives or interposed materials with bonding properties
• CPC Class Codes: Y10T 428/24008 including fastener for attaching to external surface
• CPC Class Codes: Y10T 428/24017 Hook or barb

Abstract

The present invention describes improved systems and methods for attaching external medical devices to the body of a patient using a multilayer attachment apparatus. Medical devices that require attachment to the body, including monitoring devices, drug-infusing devices and the like, can utilize embodiments of the attachment apparatus and method described herein. Embodiments of the invention include new adhesive and hook and loop attachment mechanisms and methods for using embodiments of the multilayer attachment apparatus to attach medical device and/or medical device components to the body.

Claims

1. A multilayer attachment apparatus for anchoring a medical device to a body of a user, the medical device including a cannula capable of being inserted into the body of the user, the multilayer attachment apparatus comprising:

a first layer, a second layer, and a third layer, wherein all three layers are separate from the medical device;

the first layer having a first end, a second end, a bottom surface and a top surface, wherein at least a portion of the top surface of the first layer proximate to the first end of the first layer is connectable to at least a portion of a bottom surface of a first component of the medical device including the cannula capable of being inserted into the body of the user;

the second layer having a first end, a second end, a bottom surface and a top surface;

the third layer having a bottom surface and a top surface, wherein at least a portion of the bottom surface of the second layer is connected to at least a portion of the top surface of the first layer proximate to the second end of the first layer, at least a portion of the top surface of the second layer and the bottom surface of the third layer are removably connected to one another, and at least a portion of the top surface of the third layer is connectable to at least a portion of a bottom surface of a second component of the medical device, such that the first end of the first layer is directly connectable to the first component including the cannula capable of being inserted into the body of the user while the second end of the first layer is connectable to the second component via the second and third layers between the first layer and the second component, and further wherein only the first end of the bottom surface of the second layer is connected to at least a portion of the top surface of the first layer such that an adjustable space is formed between the first layer and the second layer to enable movement of the second component relative to the second end of the first layer;

further wherein, when the medical device is anchored to the body of the user;

the cannula is inserted in the body of the user and the first component is attached to the body of the user via the first layer, and the second component is moveably attached to the first layer and body via the first, second and third layers;

further wherein, when the medical device is anchored to the body of the user and the second component is detached from the first component;

the first layer remains attached to the first component and the second layer; and

the third layer remains attached to the second component and detaches from the second layer;

such that the cannula remains inserted in the body of the user and the first component remains attached to the body via the first layer, when the second component is detached from the body.

2. The multilayer attachment apparatus of claim 1, wherein at least a portion of the bottom surface of the first layer includes an adhesive material.

3. The multilayer attachment apparatus of claim 2, further including at least one removable liner to cover at least a portion of the bottom surface of the first layer to protect the adhesive prior to use.

4. The multilayer attachment apparatus of claim 3, wherein the at least one removable liner includes a tab.

5. The multilayer attachment apparatus of claim 1, further including:

an adhesive layer having a bottom surface and a top surface, wherein at least a portion of the bottom surface of the first layer is connected to the top surface of the adhesive layer.

6. The multilayer attachment apparatus of claim 5, including the medical device, wherein each of the first layer and the adhesive layer include an aperture to receive the cannula.

7. The multilayer attachment apparatus of claim 5, further including at least one removable liner to cover at least a portion of the bottom surface of the adhesive layer to protect the adhesive prior to use.

8. The multilayer attachment apparatus of claim 1, wherein the second layer includes a plurality of loop elements and the third layer includes a plurality of hook elements.

9. The multilayer attachment apparatus of claim 1, wherein the second layer includes a plurality of hook elements and the third layer includes a plurality of loop elements.

10. The multilayer attachment apparatus of claim 1, including the medical device, wherein the first layer includes an aperture to receive the cannula.

11. The multilayer attachment apparatus of claim 1, wherein the first layer further includes a poly layer on at least a portion of the top surface of the first layer.

12. The multilayer attachment apparatus of claim 1, wherein the first layer includes a tab.

13. The multilayer attachment apparatus of claim 1, wherein the first layer includes an extended tab, wherein a top surface of the extended tab includes a fastening material connectable to a surface of the medical device.

14. The multilayer attachment apparatus of claim 13, wherein a bottom surface of the extended tab includes a poly layer.

15. The multilayer attachment apparatus of claim 1, wherein the second layer includes a tab.

16. The multilayer attachment apparatus of claim 1, wherein at least a portion of the bottom surface of the second layer includes an adhesive material.

17. The multilayer attachment apparatus of claim 1, wherein the third layer includes a tab.

18. The multilayer attachment apparatus of claim 1, wherein at least a portion of the top surface of the third layer includes an adhesive material.

19. The multilayer attachment apparatus of claim 1, including the medical device, wherein the medical device is a glucose monitoring device;

wherein the first component is a sensor base; and

wherein the second component is a sensor transmitter.

20. The multilayer attachment apparatus of claim 1, wherein the perimeter of the third layer substantially covers the bottom surface of the second component when connected to the second component.

21. The multilayer attachment apparatus of claim 1, wherein the first layer includes a nonwoven material.

22. The multilayer attachment apparatus of claim 1, wherein, when at least a portion of the top surface of the first layer proximate to the first end of the first layer and at least a portion of the top surface of the third layer are connected to at least a portion of the bottom surfaces of the first and second components of the medical device, respectively, the first layer remains connected to the bottom surface of the first component and the third layer remains connected to the bottom surface of the second component when the third layer is removed from the second layer.

23. The multilayer attachment apparatus of claim 1, wherein at least a portion of the top surface of the first layer proximate to the first end of the first layer includes an adhesive material.

24. The multilayer attachment apparatus of claim 1, wherein the first, second, and third layers are thin, flexible layers.

25. A system for improved glucose sensor monitoring device performance and accuracy comprising:

a glucose monitoring device including a sensor transmitter and a sensor base, the sensor base having a cannula and glucose sensor;

an attachment apparatus to attach the glucose monitoring device to a body of a user, the attachment apparatus including;

a first layer, a second layer, and a third layer, wherein all three layers are separate from the glucose monitoring device;

the first layer having a first end, a second end, a bottom surface and a top surface, the bottom surface of the first layer including an adhesive to attach the first layer to the body, and at least a portion of the top surface of the first end of the first layer is connected to a bottom surface of the sensor base including the cannula and glucose sensor capable of being inserted into the body of the user and the first end of the first layer includes an aperture to receive the cannula;

the second layer having a first end, a second end, a bottom surface and a top surface; and

the third layer having a bottom surface and a top surface, wherein at least a portion of the bottom surface of the second layer is connected to at least a portion of the top surface of the second end of the first layer, at least a portion of the top surface of the second layer and the bottom surface of the third layer are removably connected to one another, and at least a portion of the top surface of the third layer is connected to a bottom surface of the sensor transmitter such that the first end of the first layer is directly connected to the sensor base including the cannula and glucose sensor capable of being inserted into the body of the user while the second end of the first layer is connected to the sensor transmitter via the second and third layers between the first layer and the sensor transmitter, and further wherein only the first end of the bottom surface of the second layer is connected to at least a portion of the top surface of the first layer such that an adjustable space is formed between the first layer and the second layer to enable movement of the sensor transmitter relative to the second end of the first layer

further wherein, when the glucose monitoring device is anchored to the body of the user;

the cannula is inserted in the body of the user and the sensor base is attached to the body of the user via the first layer, and the sensor transmitter is moveably attached to the first layer and body via the first, second and third layers;

further wherein, when the glucose monitoring device is anchored to the body of the user and the sensor transmitter is detached from the sensor base;

the first layer remains attached to the sensor base and the second layer; and

the third layer remains attached to the sensor transmitter and detaches from the second layer;

such that the cannula remains inserted in the body of the user and the sensor base remains attached to the body via the first layer, when the sensor transmitter is detached from the body.

26. A method for anchoring a medical device having a first component and a second component to a body of a user, the first component including a cannula capable of being inserted into the body of the user, comprising the steps of:

providing a first layer, a second layer and a third layer, wherein all three layers are separate from the medical device;

the first layer having a first end, a second end, a top surface and a bottom surface, wherein at least a portion of the bottom surface includes an adhesive material, wherein at least a portion of the top surface of the first layer proximate to the first end of the first layer includes an adhesive material to attach to a bottom surface of the first component of the medical device including the cannula capable of being inserted into the body of the user;

the second layer having a first end, a second end, a bottom surface and a top surface, wherein at least a portion of the top surface of the first layer proximate to the second end of the first layer is connected to only the first end of the bottom surface of the second layer;

the third layer having a top surface and a bottom surface, wherein the bottom surface of the third layer is removably connectable with the top surface of the second layer and wherein at least a portion of the top surface of the third layer includes an adhesive material;

attaching the bottom surface of the first component of the medical device to at least a portion of the top surface of the first layer proximate to the first end of the first layer;

attaching at least a portion of the top surface of the third layer to a bottom surface of the second component of the medical device;

attaching the bottom surface of the first layer to the body of the user; and

attaching the bottom surface of the third layer to the top surface of the second layer such that the first end of the first layer is directly connected to the first component including the cannula capable of being inserted into the body of the user while the second end of the first layer is connected to the second component via the second and third layers between the first layer and the second component, and further wherein connection of only the first end of the bottom surface of the second layer to at least a portion of the top surface of the first layer forms an adjustable space between the first layer and the second layer to enable movement of the second component relative to the second end of the first layer;

further wherein, when the medical device is anchored to the body of the user;

the cannula is inserted in the body of the user and the first component is attached to the body of the user via the first layer, and the second component is moveably attached to the first layer and body via the first, second and third layers;

further wherein, when the medical device is anchored to the body of the user and the second component is detached from the first component;

the first layer remains attached to the first component and the second layer; and

the third layer remains attached to the second component and detaches from the second layer;

such that the cannula remains inserted in the body of the user and the first component remains attached to the body via the first layer, when the second component is detached from the body.