Infusion site interfaces and insertion devices for infusion site interfaces

• US 10,307,532 B2
• Filed: 02/03/2017
• Issued: 06/04/2019
• Est. Priority Date: 06/18/2010
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Pearson, Allen John, Collins, James Terence, Pryor, Neil Alexander
• Primary Examiner(s): Stiles, Amber R
• Application Number:
  US15/424,032
• Publication Number:
  US 20170189611A1
• Time in Patent Office: 851 Days
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1586 Holding accessories for holding infusion needles on the body holding devices for catheters A61M25/02
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0612 Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• 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 5/1626 Needle protectors therefor in combination with syringes A61M5/3202; protectors for sharps A61B50/3001

Abstract

A device for inserting an infusion cannula, or sensor, into a patient is presented. The device comprises an insertion needle removable within the infusion cannula, a handle connected to the insertion needle, and a needle cover. The needle cover pivotably mounted on the handle is rotatably movable between a first position, i.e., the front of the insertion needle is in the needle cover, and a second position, i.e., the front is exposed. An infusion site interface comprises a body mounted on a pad attached to the patient; an infusion cannula for inserting into the patient that is connected to the body; a cavity within the body fluidly connected to the cannula; and a septum that seals closed the cavity. The septum is penetrable by an insertion needle in the infusion cannula and by a hollow needle of an infusion tubing connector coupled to the infusion site interface.

Claims

1. An infusion site interface, the infusion site interface comprising:

an interface body mounted on a pad that is configured to adhesively attach to a body of a patient;

a soft infusion cannula configured for insertion into the body of the patient, wherein the infusion cannula is connected to the interface body;

wherein the interface body defines a cavity fluidly connected to the infusion cannula;

a septum that seals closed the cavity, wherein the septum has a substantially planar surface positioned opposite the cavity, wherein the septum is penetrable by an insertion needle in the infusion cannula, in a first angle to a perpendicular of the planar surface of the septum, and is penetrable by a hollow needle of an infusion tubing connector coupled to the infusion site interface, in a second angle to the perpendicular of the planar surface of the septum, wherein the same planar surface is configured to be pierced by the insertion needle and the hollow needle; and

a guide configured to guide the hollow needle of the infusion tubing connector during coupling, parallel to a plane defined by the pad, wherein the infusion tubing connector engages the guide in a horizontal direction that is parallel to the plane defined by the pad, wherein the horizontal direction defines the second angle that is different from the first angle.

2. The infusion site interface according to claim 1, wherein an insertion needle is removably arranged in the infusion cannula and penetrates the septum.

3. The infusion site interface according to claim 1, further comprising:

an insertion device for inserting the infusion cannula into a body of a patient, the device comprising;

an insertion needle adapted to be removably arranged in the infusion cannula of the infusion site interface;

a handle structure connected to the insertion needle; and

a needle cover, wherein the needle cover is pivotably mounted on the handle structure and is rotatably movable between a first position, where a front part of the insertion needle is located in the needle cover, and a second position, where the front part of the insertion needle is exposed.

4. The infusion site interface according to claim 3, wherein the needle cover of the insertion device comprises a longitudinal slot arranged such that the front part of the insertion needle passes through the slot when the needle cover is pivoted.

5. The infusion site interface according to claim 3, wherein a spring element actuates the needle cover of the insertion device toward the second position.

6. The infusion site interface according to claim 3, wherein a spring element in a first configuration is not functional and in a second configuration actuates the needle cover of the insertion device toward the second position, wherein the spring element irreversibly changes from its first configuration to its second configuration when the needle cover arrives at the second position for the first time.

7. The infusion site interface according to claim 6, wherein the spring element comprises a pawl that irreversibly snaps into a groove in the handle structure of the insertion device when the needle cover of the insertion device arrives at the second position, thereby establishing a second hinge between the spring element and the handle structure.

8. The infusion site interface according to claim 6, wherein the spring element comprises an elastic bar connected on one end with the needle cover of the insertion device by a first hinge and connected on the other end with the handle structure of the insertion device by a second hinge.

9. The infusion site interface according to claim 3, wherein the needle cover of the insertion device comprises an element slidably mounted on the handle structure of the insertion device, such that the needle cover with the sliding element is linearly movable between the first position and a third position.

10. The infusion site interface according to claim 3, wherein the insertion device further comprises one or more lock mechanisms for locking the needle cover in a position where the insertion needle is located within the needle cover.

11. The infusion site interface according to claim 3, wherein the needle cover of the insertion device comprises an element slidably mounted on the handle structure of the insertion device and linearly movable between the first position and a third position, and a rotational lock mechanism realized as a slot-tongue joint, wherein a slot is on the needle cover and the tongue is on the sliding element or vice versa, and wherein the slot and the tongue do not engage when the sliding element is in one position and do engage when the sliding element is in the other position, thereby blocking the rotational motion of the needle cover and establishing a lock of the needle cover.

12. The infusion site interface according to claim 3, wherein the needle cover of the insertion device comprises an element slidably mounted on the handle structure of the insertion device and linearly movable between the first position and a third position, and a rotational lock mechanism comprising a guiding slot, wherein a hinge of the needle cover is located outside the guiding slot when the sliding element is in one position and is located inside the guiding slot when the sliding element is in the other position, thereby blocking the rotational motion of the needle cover by making the hinge non-functional and establishing a lock of the needle cover in the first position.

13. The infusion site interface according to claim 3, wherein the needle cover of the insertion device comprises an element slidably mounted on the handle structure of the insertion device, such that the needle cover with the sliding element is linearly movable between the first position and a third position, and a translational lock mechanism realized as a linear ratchet mechanism, wherein the sliding element acts as a linear rack element of the linear ratchet mechanism and the handle structure comprises a spring-loaded pawl of the linear ratchet mechanism or vice versa.

14. The infusion site interface according to claim 3, wherein the needle cover of the insertion device comprises two parallel slots in sidewalls of the needle cover.

15. An infusion set with an infusion site interface according to claim 1.

16. An infusion pump system with an infusion site interface according to claim 1.

17. An infusion site interface, the infusion site interface comprising:

an interface body mounted on a pad that is configured to adhesively attach to a body of a patient;

a soft infusion cannula configured for insertion into the body of the patient, wherein the infusion cannula is connected to the interface body;

wherein the interface body defines a cavity fluidly connected to the infusion cannula, wherein the cavity has an opening;

a septum that seals closed the cavity, wherein the septum has a substantially planar surface that spans across the opening of the cavity to seal the opening of the cavity, wherein the planar surface of the septum is penetrable by an insertion needle in the infusion cannula, in a first angle to a perpendicular of the planar surface of the septum, and wherein the same planar surface of the septum is penetrable by a hollow needle of an infusion tubing connector coupled to the infusion site interface, in a second angle to the perpendicular of the planar surface of the septum, wherein the infusion tubing connector engages a guide in a horizontal direction that is parallel to the plane defined by the pad, wherein the horizontal direction defines the second angle that is different from the first angle; and

the guide is configured to guide the hollow needle of the infusion tubing connector during coupling, parallel to a plane defined by the pad.

18. The infusion site interface according to claim 17, wherein an insertion needle is removably arranged in the infusion cannula and penetrates the septum.

19. The infusion site interface according to claim 17, further comprising:

an insertion device for inserting the infusion cannula into a body of a patient, the device comprising;

an insertion needle adapted to be removably arranged in the infusion cannula of the infusion site interface;

a handle structure connected to the insertion needle; and

a needle cover, wherein the needle cover is pivotably mounted on the handle structure and is rotatably movable between a first position, where a front part of the insertion needle is located in the needle cover, and a second position, where the front part of the insertion needle is exposed.

20. The infusion site interface according to claim 19, wherein the needle cover of the insertion device comprises a longitudinal slot arranged such that the front part of the insertion needle passes through the slot when the needle cover is pivoted.

21. The infusion site interface according to claim 19, wherein a spring element actuates the needle cover of the insertion device toward the second position.

22. The infusion site interface according to claim 19, wherein a spring element in a first configuration is not functional and in a second configuration actuates the needle cover of the insertion device toward the second position, wherein the spring element irreversibly changes from its first configuration to its second configuration when the needle cover arrives at the second position for the first time.

23. The infusion site interface according to claim 19, wherein the needle cover of the insertion device comprises an element slidably mounted on the handle structure of the insertion device, such that the needle cover with the sliding element is linearly movable between the first position and a third position.