Infusion device and method of using and making the same

• US 8,303,545 B2
• Filed: 09/07/2007
• Issued: 11/06/2012
• Est. Priority Date: 09/07/2007
• Status: Active Grant

• Current Assignee: Stat Medical Devices Incorporated
• Original Assignee: Stat Medical Devices Incorporated
• Inventors: Schraga, Steven
• Primary Examiner(s): VU, QUYNH-NHU HOANG
• Application Number:
  US11/851,742
• Publication Number:
  US 20090069750A1
• Time in Patent Office: 1,887 Days
• Field of Search: 604/19, 604/21, 604 46- 48, 604/86, 604/93.01, 604/115, 604/117, 604/130, 604/137, 604/148, 604/158, 604/181, 604/187, 604/200, 604/206, 604/220, 604/264, 604/272, 604/288.02, 604/167.02, 606/167, 606184-185
• US Class Current: 604/167.02
• CPC Class Codes: A61M 2005/1583 Needle extractors
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/152 pressurised by contraction of elastic reservoirs containers for dispensing contents by contraction of an elastic bag provided therein, in general B65D83/0061
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

Fluid delivery device includes a body, a cannula adapted to extend into subcutaneous tissue, and a septum member adapted to allow a needle to puncture the septum member and to reseal the puncture once the needle is withdrawn from the puncture. The septum member is at least one of; a cap-shaped member, a member having at least two non-parallel walls that can each be punctured by a needle, and a member having a generally planar wall and a generally cylindrical wall which can each be punctured by a needle.

Claims

1. A fluid delivery device comprising:

a body;

at least one cannula adapted to extend into subcutaneous tissue;

a septum member adapted to allow a needle to puncture the septum member and to reseal the puncture once the needle is withdrawn from the puncture;

the septum member comprising at least one of;

a member having a puncturable section, a puncturable sidewall section, and an internal space that is in fluid communication with the cannula;

a cap-shaped member comprising an internal space that is in fluid communication with the cannula;

a cap-shaped member defining an internal space that can receive therein a tip portion of a needle when injected from plural different directions;

a member having at least two non-parallel walls that can each be punctured by a needle and defining an internal space that can receive therein a tip portion of a needle when injected from plural different directions; and

a member having a generally planar wall and a generally cylindrical wall which can each be punctured by a needle and defining an internal space that can receive therein a tip portion of a needle when injected from plural different directions; and

another internal space that is each of;

different from the internal space of the septum member;

arranged between an upper end of the cannula and the internal space of the septum member; and

in fluid communication with the internal space of the septum member.

2. The device of claim 1, wherein the body comprises an adhesive layer structured and arranged to at least temporarily secure the device to a user'"'"'s skin.

3. The device of claim 1, further comprising a removable needle insertion mechanism having a portion which extends through the cannula and another portion which can be gripped by a user.

4. The device of claim 1, further comprising a support member comprising a first opening arranged over a one portion of the septum member and at least one second opening arranged over a different portion of the septum member.

5. The device of claim 4, wherein at least one of:

the first opening comprises an axial opening and the at least one second opening comprises a generally circumferential opening or slot;

the first opening comprises an axial opening and the at least one second opening comprises a opening whose center axis is oriented at an angle between an axis of the first opening and a radial plane perpendicular to the axis of the first opening; and

the first opening comprises an axial opening and the at least one second opening comprises at least two equally angularly spaced openings.

6. The device of claim 1, wherein the cannula comprises a center axis that is oriented at an angle between a vertical center axis of the body and a radial plane perpendicular to the vertical center axis of the body.

7. The device of claim 1, wherein the cannula is oriented at an angle that is not perpendicular to a bottom surface of the body.

8. The device of claim 1, further comprising a needle insertion mechanism configured to cause movement of the cannula from a first position to a second position.

9. The device of claim 1, wherein the cannula is movable from an initial retracted position to a puncturing position.

10. The device of claim 1, wherein the cannula is movable from an initial retracted position within the body to an extended position wherein a puncturing portion of the cannula is arranged outside the body.

11. The device of claim 1, further comprising a removable safety device structured and arranged to prevent movement of the cannula from a first position to a second position.

12. The device of claim 1, further comprising a manually activated needle insertion mechanism configured to cause movement of the cannula from a first position to a second position.

13. The device of claim 1, further comprising a trigger activated needle insertion mechanism configured to cause movement of the cannula from a first position to a second position.

14. The device of claim 1, further comprising a needle insertion mechanism configured to automatically cause movement of the cannula from a first position to a second position.

15. The device of claim 1, further comprising at least one of

a needle insertion mechanism comprising a biasing mechanism for causing movement of the cannula from a first position to a second position;

and

an arrangement for adjusting a cannula penetrating depth.

16. The device of claim 1, wherein the device is adapted to function with a removable needle insertion mechanism and a tool comprising a biasing mechanism for causing movement of the cannula from a first position to a second position.

17. The device of claim 1, wherein the device is adapted to function with a removable needle insertion mechanism and a trigger activated tool comprising a biasing mechanism and a movable member for causing movement of the cannula from a first position to a second position.

18. The device of claim 1, further comprising at least one of:

a system for causing movement of the cannula from a first position to a second position; and

a system for causing movement of the cannula from an extended position to a retracted position.

19. The device of claim 1, wherein the device is a single-use device.

20. The device of claim 1, further comprising a removable cannula insertion mechanism adapted to move the cannula to a puncturing position.

21. The device of claim 1, further comprising at least one of:

an adjustable septum support member adapted to move the septum between at least two angular positions; and

a swivel mounted septum support member adapted to move the septum between at least two angular positions.

24. A method of making the fluid delivery device of claim 1, the method comprising:

mounting a cannula and a septum to a body.

25. A method of using the fluid delivery device of claim 1, the method comprising:

attaching the device to a user'"'"'s skin; and

inserting a portion of the cannula into the subcutaneous tissue.

22. A fluid delivery device comprising:

a body;

at least one cannula adapted to extend into subcutaneous tissue;

an insertion mechanism adapted to be gripped by a user and adapted to facilitate insertion of the cannula into the subcutaneous tissue;

a septum member adapted to allow a needle to puncture the septum member and to reseal the puncture once the needle is withdrawn from the puncture;

the septum member comprising at least one of;

a one-piece member having a puncturable wall, a puncturable sidewall, and an internal space that is in fluid communication with the cannula;

a cap-shaped member defining an internal space that is in fluid communication with the cannula;

a member having at least two non-parallel walls that can each be punctured by a needle and defining an internal space that is in fluid communication with the cannula; and

a member having a generally planar wall and a generally cylindrical wall which can each be punctured by a needle, and defining an internal space that is in fluid communication with the cannula; and

another internal space that is each of;

different from the internal space of the septum member;

arranged between an upper end of the cannula and the internal space of the septum member; and

in fluid communication with the internal space of the septum member.

23. A fluid delivery device comprising:

a body;

at least one cannula adapted to extend into subcutaneous tissue;

an insertion mechanism adapted to be gripped by a user and comprising a needle portion adapted to facilitate insertion of the cannula into the subcutaneous tissue;

a one-piece septum member adapted to allow a needle to puncture the septum member and to reseal the puncture once the needle is withdrawn from the puncture;

the septum member comprising at least one of;

a member having a puncturable main wall, a puncturable sidewall, and an internal space that is in fluid communication with the cannula;

a cap-shaped member comprising a main puncturable and resealable section, a side puncturable and resealable section, and an internal needle receiving space;

a member having at least two non-parallel walls that can each be punctured by a needle and an internal needle receiving space; and

a member having a generally planar wall, a generally cylindrical wall which can each be punctured by a needle, and an internal needle receiving space; and

another internal space that is each of;

different from the internal space of the septum member;

arranged between an upper end of the cannula and the internal space of the septum member; and

in fluid communication with the internal space of the septum member.

26. A fluid delivery device comprising:

a body;

at least one cannula adapted to extend into subcutaneous tissue;

the at least one cannula being movable relative to the body from an initial retracted position to a puncturing position;

a cap-shaped septum member adapted to allow a needle to puncture the septum member from at least two different directions and to reseal each puncture once the needle is withdrawn from each puncture, and

said at least one cannula

having an upper end spaced from an inner surface of an upper end of the septum member when in the puncturing position,

wherein the upper end of the septum member is arranged over the upper end of the cannula after the cannula is moved to the puncturing position.

27. The device of claim 26, wherein the cap-shaped septum member comprises at least one of:

a member having a first section and a side wall section that can each be punctured by a needle and defining an internal space;

a member having a main wall and a side wall that can each be punctured by a needle and defining an internal space;

a member having at least two non-parallel walls that can each be punctured by a needle and defining an internal space; and

a member having a generally planar wall and a generally cylindrical wall which can each be punctured by a needle and defining an internal space.

28. The device of claim 26, wherein the cap-shaped septum member comprises:

a first puncturable and resealable section that can be punctured by a needle arranged parallel to an axis of the cannula and that can inject a substance which can pass through the cannula; and

a second section that can be punctured by a needle that is not arranged parallel to an axis of the cannula and that can inject a substance which can pass through the cannula.

29. The device of claim 26, wherein the cap-shaped septum member comprises:

a first section that is puncturable and resealable and that can be punctured along a direction parallel to an axis of the cannula; and

a second section that can be punctured along a different direction that is not arranged parallel to an axis of the cannula,

wherein the first section and the second section define an internal space which can receive a substance injected through the main section and the other section.

30. The device of claim 29, further comprising a support member comprising:

a main opening allowing insertion of a needle along a direction parallel to an axis of the cannula; and

another opening allowing insertion of a needle along a different direction that is not arranged parallel to an axis of the cannula.

31. The device of claim 26, further comprising a support member covering the septum member and comprising:

a main opening allowing insertion of a needle along a main direction; and

at least one other opening allowing insertion of a needle along a direction different from the main direction.

32. The device of claim 31, wherein the cap-shaped septum member is a one-piece member that comprises:

a main section that can be punctured along a direction parallel to an axis of the cannula; and

another section that can be punctured along a different direction that is not arranged parallel to an axis of the cannula.

33. A fluid delivery device comprising:

a body;

at least one cannula adapted to extend into subcutaneous tissue;

the at least one cannula being movable relative to the body from an initial retracted position to a puncturing position;

a septum member adapted to allow a needle to puncture the septum member from at least two different directions and to reseal each puncture once the needle is withdrawn from each puncture;

said at least one cannula being at least one of;

movable relative to the septum when the septum is coupled to the body; and

movable away from the septum when moved from the initial retracted position to the puncturing position; and

a support member comprising;

a first opening allowing insertion of a needle along a direction parallel to an axis of the cannula and configured to allow puncturing of the septum; and

at least one second opening allowing insertion of a needle along a different direction that is not arranged parallel to an axis of the cannula and configured to allow puncturing of the septum,

wherein, in the retracted position, an upper end of the cannula is arranged between an upper end of the septum member and a skin attaching surface of the body.