MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING MEDICAL DEVICES

• US 20110288574A1
• Filed: 03/24/2011
• Published: 11/24/2011
• Est. Priority Date: 03/24/2010
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Curry, Samuel Mason, Pace, Louis G, Robinson, Peter G, Nguyen, Tuan, Donnay, Manuel Luis, Yee, Philip
• Granted Patent: US 9,265,453 B2
• Time in Patent Office: Days
• US Class Current: 606/185
• CPC Class Codes: A61B 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00384 Actuation of one tool by pushing two buttons simultaneously
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15016 by accessories for bringing the piercing element into the body, e.g. through rotation of the piercing element
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150732 : Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• CPC Class Codes: A61B 5/15087 : short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/15107 : Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15113 : Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 : comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1513 : comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15186 : Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/1519 : comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 : fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6848 : Needles
• CPC Class Codes: A61B 5/6865 : Access ports
• CPC Class Codes: A61M 2005/1585 : Needle inserters
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices.

Claims

1. An apparatus for inserting a medical device at least partially through the skin of a subject, which comprises:

a first subassembly comprising

a sheath defining a distal surface for placement on the skin of the subject;

a handle movable between a proximal position and distal position;

a device support for supporting the medical device and defining an aperture therethrough, the device support coupled to the handle;

a sharp support for supporting a sharp extending through said aperture and coupled to the device support; and

a first driver for biasing the sharp support towards the proximal position; and

a second subassembly comprising

a housing configured for removable attachment to the first subassembly; and

a second driver for advancing the sharp support towards the distal position.

2. The apparatus of claim 1, wherein the second driver comprises a rotatable cam.

3. The apparatus of claim 1, wherein the second driver comprises a torsion spring.

4. The apparatus of claim 1, wherein the second driver comprises an axial driver and a crank assembly.

5. The apparatus of claim 1, wherein the second driver comprises a compression spring.

6. The apparatus of claim 1, wherein the handle is at least partially disposed surrounding the sheath.

7. The apparatus of claim 1, further comprising a bellows portion disposed between the sheath and the handle.

8. The apparatus of claim 1, further comprising a retention member for retaining the device support in the distal position.

9. The apparatus of claim 1, wherein the device support is coupled to the handle until the device support reaches a distal position.

10. The apparatus of claim 1, further comprising a second driver for biasing the device support towards the distal position.

11. An apparatus for inserting a medical device at least partially through the skin of a subject, which comprises:

a first subassembly comprising

a sheath defining a distal surface for placement on the skin of the subject;

a handle movable between a proximal position and distal position;

a device support for supporting the medical device and movable between a proximal and distal position with respect to the sheath in response to distal movement of the handle;

a sharp support for supporting a sharp and movable between a proximal and distal position with respect to the sheath in response to distal movement of the handle; and

a first driver for biasing the sharp support towards the proximal position; and

a second subassembly comprising

a housing configured for removable attachment to the first subassembly

an actuator configured for distal movement with respect to the housing and a release member actuated upon the actuator reaching predetermined position; and

a second driver for advancing the handle towards the distal position,

wherein the biasing member is released upon actuation of the release member.

27. The apparatus of claim 11, wherein the second driver comprises a compression spring.

28. The apparatus of claim 11, wherein the first driver comprises a compression spring.

29. The apparatus of claim 11, wherein the handle is at least partially disposed surrounding the sheath.

30. The apparatus of claim 11, wherein the housing is configured for friction-fit attachment to the first subassembly.

31. The apparatus of claim 11, wherein the first subassembly is configured for a single use.

32. The apparatus of claim 11, wherein the second subassembly is configured for multiple uses.

33. The apparatus of claim 11, wherein the second driver contacts the handle.

34. The apparatus of claim 11, wherein the handle is movable between a proximal position and distal position;

the device support is movable between a proximal and distal position with respect to the sheath in response to distal movement of the handle;

the sharp support is movable between a proximal and distal position with respect to the sheath in response to distal movement of the handle; and

the first driver is capable of biasing the sharp support towards the proximal position when the second subassembly is removed from the first subassembly.

11-26. -26. (canceled)