Cartridge and inserter for a medical system

Patent metadata

Field	Value
Publication number	US-11793934-B2
Application number	US-202016917059-A
Country	US
Kind code	B2
Filing date	Jun 30, 2020
Priority date	May 26, 2015
Publication date	Oct 24, 2023
Grant date	Oct 24, 2023

Abstract

Disclosed is a medical system having a cartridge and an inserter. The cartridge includes a housing having an interior volume with a first guide within the interior volume. A cradle is disposed within the interior volume and is configured for mounting a medical appliance. The cradle includes a subcutaneous element and an insertion needle. The insertion needle is configured for being actuated to insert the subcutaneous element into a subject. The inserter includes a second guide configured to mate with the housing of the cartridge, and the first guide and second guide are configured to cooperate to guide the inserter into the interior volume along a guiding path defined by the first guide. The inserter is configured to removably attach to the cradle when guided into the interior volume. An insertion assembly is provided for actuating the insertion needle to insert the subcutaneous element into the subject.

First claim

What is claimed is:

1. A cartridge adapted for use with an inserter having an insertion assembly, the cartridge comprising:
a housing having an interior volume and having a first guide within the interior volume wherein the first guide is adapted to engage an inserter and guide the inserter at least partially into the interior volume along a guide path; and
a cradle disposed within the interior volume and configured for mounting a medical appliance, the cradle comprising a subcutaneous element and an insertion needle, the cradle being adapted to attach to the inserter and be removable from the housing after attachment to the inserter and wherein the insertion needle is configured for being actuated to insert the subcutaneous element into a subject after the cradle is removed from the housing.

2. The cartridge of claim 1 , wherein a portion of the housing defines a rigid element which engages a sliding element of the inserter to prime a stored energy source of the insertion assembly of the inserter with stored energy when at least a portion of the insertion assembly is moved into the interior volume of the housing along the guide path.

3. The cartridge of claim 2 , wherein the rigid element is formed by the first guide.

4. The cartridge of claim 1 , wherein the cradle comprises an adhesive layer configured to attach to an exterior surface of a subject, wherein the cradle comprises a backing material layer covering the adhesive layer to prevent the adhesive layer from sticking to the interior volume, wherein the housing defines an opening in communication with the interior volume, wherein a portion of the backing material is attached to the housing.

5. The cartridge of claim 4 , wherein the portion of the backing material attached to the housing is configured to peel the backing material from the adhesive layer when the cradle is removed from the housing.

6. The cartridge of claim 5 , wherein the portion of the backing material attached to the housing is configured to remain attached to the housing when the cradle is removed from the housing along the guide path.

7. The cartridge of claim 1 , wherein the housing defines an opening in communication with the interior volume, wherein the opening is planar, wherein the interior volume has a triangular profile perpendicular to the guiding path, wherein the opening is tilted with respect to a bottom plane of the housing such that the housing has a wedge shape.

8. The cartridge of claim 7 , wherein the opening is tilted with respect to the bottom plane of the housing between 20 degrees and 60 degrees.

9. The cartridge of claims 1 , wherein the first guide is formed in a first side wall of the interior volume.

10. The cartridge of claim 9 , wherein the interior volume has a second side wall opposing the first side wall, wherein the second side wall comprises a supplementary guide.

11. The cartridge of claim 1 , further comprising a needle housing attached to the cradle wherein the insertion needle is positioned within the needle housing prior to insertion of the subcutaneous element and wherein the needle housing with the insertion needle disposed therein are detachable from the cradle after insertion of the subcutaneous element.

12. A medical system, comprising:
(a) a cartridge, comprising:
(i) a housing having an interior volume and having a first guide within the interior volume; and
(ii) a cradle disposed within the interior volume and configured for mounting a medical appliance, the cradle comprising a subcutaneous element and an insertion needle, wherein the insertion needle is configured for being actuated to insert the subcutaneous element into a subject; and

(b) an inserter, comprising:
(i) a second guide configured to mate with the housing of the cartridge, wherein the first guide and second guide are configured to cooperate to guide the inserter into the interior volume along a guide path and wherein the inserter is configured to removably attach to the cradle when guided into the interior volume and wherein the inserter and attached cradle are removable from the interior volume of the housing; and
(ii) an insertion assembly for actuating the insertion needle to insert the subcutaneous element into the subject after removal of the inserter and attached cradle from the interior volume of the housing.

13. The system of claim 12 , wherein the insertion assembly comprises an energy source for driving the insertion needle into the subject and out of the subject, wherein the housing comprises a rigid element for engaging a sliding element of the inserter, wherein the energy source is configured for being primed with stored energy when the sliding element of the inserter is pressed against the rigid element and the inserter is moved into the interior volume of the housing along the guide path.

14. The system of claim 13 , wherein inserter comprises a cover, wherein the second guide is a first groove formed in the cover, wherein the sliding element slides within the first groove, and wherein the sliding element is configured for priming the energy source with stored energy when moved along the first groove.

15. The system of claim 14 , wherein the inserter further comprises an additional guide comprising a second groove formed in the cover, wherein the additional guide is aligned with the guide path.

16. The system of claim 13 , wherein the inserter comprises a button for activating the insertion assembly when the energy source is primed with stored energy.

17. The system of claim 12 , wherein the insertion assembly comprises a safety having a sensing point and the inserter has a mounting surface wherein the mounting surface defines a plane through which the safety extends when the energy source is primed with stored energy, wherein the safety is configured for being depressed such that the sensing point lies in the plane defined by the mounting surface when the energy source is primed with stored energy, wherein the insertion assembly is locked unless the safety is depressed such that the sensing point lies in the plane defined by the mounting surface.

18. The system of claim 12 , wherein at least a portion of the inserter mates with the interior volume of the cartridge.

19. The system of claim 12 , further comprising a needle housing attached to the cradle wherein the insertion needle is positioned within the needle housing prior to insertion of the subcutaneous element and wherein the needle housing with the insertion needle disposed therein are detachable from the cradle after insertion of the subcutaneous element.

Assignees

• Roche Diabetes Care Inc

Inventors

• Deck Frank

Classifications

• A61M5/162 Primary

  Needle sets, i.e. connections by puncture between reservoir and tube {; Connections between reservoir and tube (in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14)} · CPC title

• A61M5/14248 Primary

  of the skin patch type · CPC title

• A61M5/158

  Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body} · CPC title

• A61M2005/14252

  with needle insertion means · CPC title

• A61M2005/1585

  Needle inserters · CPC title