Insertion device

Abstract

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Claims

2026223334   28 Aug 2026I__X                                                               I__X5       CLAIMS1.     An insertion device for transcutaneous placement of a needle assembly through skinof a patient, the insertion device comprising:a housing having a proximal end and a distal end, the housing comprising a shell defining an interior space and having a proximal opening at the proximal end configured to permit passage of the needle assembly therethrough;a carriage slidably received within the interior space and movable between a retracted position and an extended position;a drive configured to bias the carriage toward the extended position; andat least one ergonomic feature on an exterior surface of the housing at the proximal end, the at least one ergonomic feature configured to facilitate positioning of the housing against the skin of the patient.

2. The insertion device of claim 1, wherein the at least one ergonomic feature comprises20 at least one curvature formed in the exterior surface of the housing at the proximal end, the at least one curvature shaped to conform to skin of the patient.

3. The insertion device of claim 2, wherein the at least one curvature comprises twoinward curving outlines formed at the proximal end of the housing.

254. The insertion device of claim 1 or 2, wherein the at least one ergonomic featurecomprises at least one curvature configured to rest a thumb and middle finger of a user when pressing the housing against the skin of the patient.30   5.     The insertion device of any one of claims 1 to 4, wherein the at least one ergonomicfeature comprises a plurality of haptic or sensitization points on the exterior surface of the housing, the haptic or sensitization points configured to distract a patient from a needle puncture when the insertion device is actuated.35   6.     The insertion device of any one of claims 1 to 5, wherein the housing is cylindricaland has a proximal end that is larger in diameter than a distal end of the housing.

7. The insertion device of any one of claims 1 to 6, wherein the carriage comprises:a platform;2026223334   28 Aug 2026I__X                                                         I__X5 a pillar coupled to the platform and extending toward the proximal opening; anda plurality of fingers coupled to the pillar and extending laterally away from the pillar, the plurality of fingers configured to releasably receive and retain the needle assembly.

8. The insertion device of claim 7, wherein each of the plurality of fingers has a convexshape and includes a through groove configured to engage a guide wedge on an inner wall ofthe housing.

9. The insertion device of claim 7 or 8, wherein the plurality of fingers are made of aflexible material and are configured to expand radially away from the pillar to release the needle assembly when the carriage is in the extended position, and to compress radially toward the pillar to grip the needle assembly when the carriage is in the retracted position.

10. The insertion device of any one of claims 7 to 9, wherein the pillar comprises a frame configured as a recess to receive a main body of the needle assembly therein.2011. An insertion device for transcutaneous placement of a needle assembly through skin of a patient, the insertion device comprising:a housing comprising a shell with a distal opening and a proximal opening;a carriage slidably received within the shell between an extended position and a retracted25 position, the carriage comprising elements configured to releasably secure the needle assembly;a drive spring positioned within the housing and configured to bias the carriage toward the extended position;a trigger-type actuator comprising:30          a cap coupled to a distal end of the housing;a button slidably received within the cap, the button comprising a cylindrical sleeve with a tapered leading-edge face; anda trigger spring positioned within the cap and configured to urge the button toward a distal end of the cap;35          wherein the button has a top surface that is recessed below a top surface of the cap toprevent accidental actuation of the trigger-type actuator.

12. The insertion device of claim 11, wherein the carriage comprises at least one trigger arm extending from a platform of the carriage toward the distal opening, the at least one 40 trigger arm including a trigger finger having a ramped outboard face configured to interact2026223334   28 Aug 2026I__X                                                         I__X5 with the tapered leading-edge face of the cylindrical sleeve to radially compress the at least one trigger arm when the button is depressed, thereby releasing the carriage from the retracted position.

13. The insertion device of claim 12, wherein the at least one trigger arm comprises a plurality of trigger arms, and the trigger finger of each of the plurality of trigger arms comprises an out-turned structure extending laterally away from a centerline of the carriage.

14. The insertion device of claim 12 or 13, wherein the trigger finger comprises a distal end, a ramp portion extending proximally and laterally outwardly from the distal end, and a step or tooth at a proximal end of the ramp portion.

15. The insertion device of any one of claims 12 to 14, wherein the drive spring comprises a coil spring positioned to at least partially encircle the at least one trigger arm.20    16. The insertion device of any one of claims 12 to 15, wherein the at least one triggerarm is resilient such that, when the carriage moves from the extended position to the retracted position, the trigger finger is adapted for partial radial compression as the trigger finger passes through the distal opening, and upon reaching the retracted position, the trigger finger springs outwardly to engage a shoulder of the distal opening to retain the carriage in the25 retracted position.

17. The insertion device of any one of claims 11 to 16, wherein the cap and the housing are coupled by at least one of: threads, interference fit, snap fit, or complementary grooves and projections3018. A subcutaneous infusion system for delivering medication to a patient, the system comprising:a needle assembly comprising a main body, at least one stabilization wing attached to the main body, a medication supply tubing in communication with a needle extending from the 35 main body; andan insertion device according to any one of claims 1 to 10, the insertion device configured to releasably secure the needle assembly and to transcutaneously place the needle through skin of the patient upon actuation.402026223334   28 Aug 2026I__X                                                               I__X5   19. A method of positioning a needle assembly for transcutaneous insertion into a patientwith reduced discomfort, the method comprising:obtaining an insertion device according to any one of claims 1 to 10;loading the needle assembly into the carriage to releasably secure the needle assembly;positioning the insertion device against skin of the patient with the at least one ergonomic0 feature in contact with or proximate to the skin of the patient; andactuating the insertion device to cause the carriage and the needle assembly to move from the retracted position to the extended position, thereby inserting the needle assembly through the skin of the patient.

20. Use of an insertion device according to any one of claims 1 to 17 for subcutaneous,intravenous, intramuscular, or intradermal delivery of medication to a patient.

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