Adhesive patch systems and methods

• US 9,522,225 B2
• Filed: 03/25/2009
• Issued: 12/20/2016
• Est. Priority Date: 04/30/2007
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Chong, Colin A., Griffin, Christopher G.
• Primary Examiner(s): Schmidt, Emily
• Assistant Examiner(s): PENG, LAUREN MICHELE
• Application Number:
  US12/411,236
• Publication Number:
  US 20090198215A1
• Time in Patent Office: 2,827 Days
• Field of Search: 604/21, 604 86- 88, 604/111, 604/173, 604200-205, 604/500, 604/507
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/31516 reducing dead-space in the syringe barrel after delivery
• CPC Class Codes: A61M 2005/341 angularly adjustable or angled away from the axis of the injector
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• 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 5/165 Filtering accessories, e.g. blood filters, filters for infusion liquids A61M1/14 , A61M1/34, A61M1/3627, A61M1/3679, A61M1/3687 take precedence; needle sets with incorporated air inlet filters A61M5/162
• CPC Class Codes: A61M 5/36 with means for eliminating or preventing injection or infusion of air into body dialysis systems, blood oxygenators A61M1/14; haemofiltration equipment A61M1/34; automatic tube cut-off A61M39/281

Abstract

Various embodiments of the present invention are directed to patches for medical devices. In various embodiments, an adhesive patch of a medical device may have selective areas with adhesive material of varying adhesion strengths. In other embodiments, an adhesive patch of a medical device may include adhesive material that may be activated by a catalyst to increase or decrease the adhesion strength of the adhesive material. In further embodiments, a medical device may include a pierceable membrane containing an agent, the pierceable membrane positioned to be pierced by a needle and to cause some of the agent to be carried to the user-patient.

Claims

1. A medical device comprising:

a medical monitoring device comprising a sensor configured to detect a biological parameter on a patient or a treatment device comprising an electronic infusion pump configured to deliver an infusion medium to a patient, the medical monitoring or treatment device including and operable with an insertion needle positioned to be inserted into the patient to insert a cannula into the patient, the insertion needle configured to extend through the cannula when the insertion needle is inserted into a patient to insert the cannula into the patient, the insertion needle configured to be withdrawn from the cannula to leave the cannula at least partially in the patient after the cannula is inserted into the patient, the cannula having an interior channel for conveying fluid to or from the medical monitoring or treatment device after the insertion needle is withdrawn from the cannula and during operation of the medical monitoring or treatment device;

a pierceable membrane defining an interior volume containing an agent, the pierceable membrane positioned to be pierced by the insertion needle to allow the insertion needle to cause at least some of the agent contained in the interior volume of the pierceable membrane to be communicated from the interior volume of the pierceable membrane, outside the cannula, to the patient as the insertion needle is moved to an insertion position to be inserted into the patient with the cannula; and

a base adapted to be secured to the patient during operation of the medical monitoring or treatment device, the base having a bottom surface that is arranged to contact a portion of the skin of the patient when the base is secured to the patient;

wherein the pierceable membrane is arranged on and attached to the bottom surface of the base such that the insertion needle is external to the internal volume of the pierceable membrane when the needle begins to move toward the insertion position, and such that the insertion needle passes through the pierceable membrane on the bottom surface of the base as the insertion needle continues to move to the insertion position; and

wherein the pierceable membrane is positioned between a portion of the bottom surface of the base and the skin of the patient in a case where the base is secured to the patient during operation of the medical monitoring or treatment device.

2. The medical device according to claim 1,

wherein the insertion needle carries the at least some of the agent from the interior volume of the pierceable membrane to the patient.

3. The medical device according to claim 1,

wherein the insertion needle pierces the pierceable membrane to allow the at least some of the agent to flow from the interior volume of the pierceable membrane to the patient.

4. The medical device according to claim 1, the base adapted to be secured to the skin of the patient.

5. The medical device according to claim 4, at least one of the pierceable membrane and the agent configured to allow at least some of the agent to react with the skin of the patient before the pierceable membrane is pierced by the insertion needle.

6. The medical device according to claim 1,

wherein the agent comprises an antiseptic.

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

a removable layer at least partially covering the pierceable membrane.

8. The medical device according to claim 7,

wherein the pierceable membrane is reactable with air upon the removable layer being at least partially removed from the pierceable membrane.

9. The medical device according to claim 1,

the insertion needle having an outer surface;

wherein at least some of the agent collects on the outer surface of the insertion needle upon the insertion needle piercing the pierceable membrane;

wherein the at least some of the agent is carried on the outer surface of the insertion needle as the insertion needle moves to the patient.

10. The medical device according to claim 1, wherein the insertion needle is supported at least partially within the cannula for movement with the cannula relative to the pierceable membrane and the patient.

11. The medical device according to claim 1:

wherein the base is adapted to be secured to the skin of the patient during operation of the medical monitoring or treatment device, the base supporting the pierceable membrane;

wherein the insertion needle is supported at least partially within the cannula for movement with the cannula relative to the pierceable membrane and the base.

12. The medical device according to claim 11, wherein the insertion needle is supported for movement relative to the base.

13. The medical device according to claim 1, wherein the insertion needle is supported for movement with the cannula to pierce the pierceable membrane and then pierce the patient after piercing the pierceable membrane.

14. The medical device according to claim 1, wherein the base is adapted to be secured to the skin of the patient during operation of the medical monitoring or treatment device, the base supporting the insertion needle for movement with the cannula relative to the base to pierce the pierceable membrane and then pierce the skin of the patient after piercing the pierceable membrane in a case where the base is secured to the skin of the patient.

15. The medical device according to claim 1, wherein, in one motion, the insertion needle penetrates a first side of the pierceable membrane, then the agent, then a second side of the pieceable membrane, then the patient.

16. The medical device according to claim 1, wherein a sharp end of the needle is external to the internal volume of the pierceable membrane after the insertion needle passes through the pierceable membrane.

17. The medical device according to claim 1, wherein the medical monitoring or treatment device comprises a treatment device comprising an electronic infusion pump, said treatment device further comprising:

a first member having a reservoir for containing an infusion medium; and

a second member having an injection site structure through which the insertion needle is inserted as the insertion needle moves to the insertion position;

wherein the first member is separate from but selectively connectable to the second member, such that when connected, there is a fluid flow connection between the reservoir and the insertion needle when the insertion needle is in the insertion position.

18. The medical device according to claim 1, wherein the medical monitoring or treatment device comprises a medical monitoring device comprising a sensor, said medical monitoring device further comprising:

a first member of the medical device having said sensor; and

a second member having an injection site structure through which the insertion needle is inserted as the insertion needle moves to the insertion position;

wherein the first member is separate from but selectively connectable to the second member, such that when connected, there is a fluid flow connection between the first member and the insertion needle when the insertion needle is in the insertion position.

19. The medical device according to claim 1, wherein the bottom surface of the base has a generally flat section that contacts the portion of the skin of the patient when the base is secured to the patient, wherein the pierceable membrane is attached to a portion of the generally flat section of the base.

20. The medical device according to claim 19, wherein the portion of the generally flat section to which the piercable membrane is attached is flat and contiguous with the generally flat section that contact the portion of the skin of the patient when the base is secured to the patient.

21. A delivery method comprising:

providing a medical monitoring device comprising a sensor configured to detect a biological parameter on a patient through a cannula or a treatment device comprising an electronic infusion pump configured to deliver an infusion medium to a patient through a cannula, the medical monitoring or treatment device operable with an insertion needle for inserting the cannula into the patient;

extending the insertion needle through the cannula and supporting the insertion needle and the cannula in a position for insertion of the insertion needle and cannula into the patient, the insertion needle configured to be withdrawn from the cannula to leave the cannula at least partially in the patient after the cannula is inserted into the patient, the cannula having an interior channel for conveying fluid to or from the medical monitoring or treatment device after the insertion needle is withdrawn from the cannula and during operation of the medical monitoring or treatment device;

positioning a pierceable membrane to define an interior volume containing an agent to be pierced by the insertion needle during operation of the medical monitoring or treatment device and to allow the insertion needle to cause at least some of the agent contained in the interior volume of the pierceable membrane to be communicated from the interior volume of the pierceable membrane, outside the cannula, to the patient as the insertion needle is moved to an insertion position to be inserted with the cannula into the patient; and

providing a base adapted to be secured to the skin of the patient during operation of the medical monitoring or treatment device, the base having a bottom surface that is arranged to contact a portion of the skin of the patient when the base is secured to the patient;

wherein the pierceable membrane is arranged on and attached to the bottom surface of the base such that the insertion needle is external to the internal volume of the pierceable membrane when the needle begins to move toward the insertion position, and such that the insertion needle passes through the pierceable membrane on the bottom surface of the base as the insertion needle continues to move to the insertion position; and

wherein the pierceable membrane is positioned between a portion of the bottom surface of the base and the skin of the patient in a case where the base is secured to the patient during operation of the medical monitoring or treatment device.

22. The method according to claim 21, the method further comprising:

moving the insertion needle relative to the pierceable membrane to pierce the pierceable membrane;

collecting at least some of the agent on an outer surface of the insertion needle upon the insertion needle piercing the pierceable membrane; and

carrying the at least some of the agent on the outer surface of the insertion needle to the skin of the patient.

23. The method according to claim 22, the method further comprising:

supporting the pierceable membrane on the base in a position such that a portion of the agent flows to the skin of the patient in a case where the base is secured to the skin of the patient and the insertion needle pierces the pierceable membrane.

24. The method according to claim 21, the method further comprising:

supporting the insertion needle at least partially within the cannula for movement with the cannula relative to the base to pierce the pierceable membrane and then pierce the skin of the patient after piercing the pierceable membrane in a case where the base is secured to the skin of the patient.

25. The method according to claim 21, further comprising:

penetrating with the insertion needle, in one motion, a first side of the pierceable membrane, then the agent, then a second side of the pieceable membrane, then the patient.

26. The method according to claim 21, wherein a sharp end of the needle is external to the internal volume of the pierceable membrane after the insertion needle passes through the pierceable membrane.

27. The method according to claim 21,

wherein the medical monitoring or treatment device comprises a treatment device comprising an electronic infusion pump, said treatment device further comprising:

a first member having a reservoir for containing an infusion medium; and

a second member having an injection site structure through which the insertion needle is inserted as the insertion needle moves to the insertion position;

wherein the first member is separate from but selectively connectable to the second member, such that when connected, there is a fluid flow connection between the reservoir and the insertion needle when the insertion needle is in the insertion position.

28. The method according to claim 21,

wherein the medical monitoring or treatment device comprises a medical monitoring device comprising a sensor, said medical monitoring device further comprising:

a first member of the medical device having said sensor; and

a second member having an injection site structure through which the insertion needle is inserted as the insertion needle moves to the insertion position;

wherein the first member is separate from but selectively connectable to the second member, such that when connected, there is a fluid flow connection between the first member and the insertion needle when the insertion needle is in the insertion position.

29. The method of claim 21, wherein the bottom surface of the base has a generally flat section that contacts the portion of the skin of the patient when the base is secured to the patient, wherein the pierceable membrane is attached to a portion of the generally flat section of the base.

30. The method of claim 29, wherein the portion of the generally flat section to which the piercable membrane is attached is flat and contiguous with the generally flat section that contact the portion of the skin of the patient when the base is secured to the patient.