Continuous analyte monitor inserter apparatus and methods
Inventors
Gass, Jennifer L. • Prais, Eugene • Mayer, JR., Thomas A. J. • Young, Cameron M. • Erekovcanski, Nicholas
Assignees
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Publication Number
US-12193707-B2
Publication Date
2025-01-14
Expiration Date
Abstract
An apparatus for inserting a continuous analyte monitoring transmitter that includes an outer member, an inner member configured to telescope relative to the outer member, a transmitter, a bias member, an insertion device, and a pivot member. Force is applied to press the outer member toward an insertion site over the duration of a stroke. During a first portion of the stroke, the pivot member cannot pivot and the motion of the outer member translates to the insertion device until the biosensor is inserted at the insertion site. Over a second portion of the stroke, the continued motion causes a first pivot window in the outer member to overlap with a second pivot window in the inner member, allowing the pivot member to pivot and retract the insertion device from the insertion site, leaving the implanted biosensor. Upon completion of the stroke, the position of the pivot member is locked into place by engaging a locking feature of the bias member with the second pivot window to prevent the insertion member from re-entering the insertion site.
Core Innovation
The invention is a continuous analyte monitoring inserter apparatus that uses an outer member and an inner member configured to slidably fit axially within the outer member. The outer member includes a first pivot window, and the inner member includes a second pivot window. A transmitter carrier supports a transmitter and biosensor assembly within the inner member, and an insertion device is supported by a pivot member configured to pivot relative to the transmitter carrier.
Axial movement of the outer member slides over the inner member and presses a bias member against an end of the pivot member. During a first portion of a stroke, the bias member causes the pivot member to impart the axial movement to the transmitter carrier and the insertion device. Over a second portion of the stroke, the pivot member pivots to retract the insertion device when the end of the pivot member passes through an opening created by overlapping of the first pivot window with the second pivot window.
Upon completion of the second portion of the stroke, a locking feature of the bias member engages with the second pivot window to prevent the bias member from retracting. This thereby prevents the pivot member from pivoting after insertion of a biosensor. Variations described include pre-insertion lock features, alignment features for vertical/rotational alignment of pivot windows, internal guidance features, and a transmitter/biosensor assembly detachably coupled to the transmitter carrier using retainer tangs and relief openings.
Claims Coverage
The document provides three independent claims, each defining the core inserter apparatus structure and the associated forming and insertion processes. Across the independent claims, the key inventive approach is a coordinated two-part stroke in which axial translation drives insertion while a window-overlap condition permits pivoting/retraction, followed by a bias-member locking feature that prevents post-insertion pivoting.
Telescoping outer and inner members with first and second pivot windows
The apparatus includes an outer member comprising a first pivot window, and an inner member configured to slidably fit axially within the outer member, the inner member comprising a second pivot window.
Bias-driven pivot member and two-portion stroke with window overlap
A transmitter carrier comprising a bias member supports a transmitter and biosensor assembly within the inner member, and a pivot member pivots relative to the transmitter carrier to support an insertion device. Axial movement of the outer member slides over the inner member and presses the bias member against an end of the pivot member; over a first portion of a stroke the bias member causes the pivot member to impart axial movement to the transmitter carrier and the insertion device; and over a second portion of the stroke the pivot member pivots to retract the insertion device when the end of the pivot member passes through an opening created by overlapping of the first pivot window with the second pivot window.
Bias-member locking feature engages pivot window to prevent post-insertion pivoting
Upon completion of the second portion of the stroke, a locking feature of the bias member engages with the second pivot window to prevent the bias member from retracting, thereby preventing the pivot member from pivoting after insertion of a biosensor.
Forming an inserter apparatus by assembling pivot/bias/transmitter carrier with pivot windows and alignment features
A method of forming an inserter apparatus comprising assembling a transmitter carrier assembly, inserting the transmitter carrier assembly into an inner member with an inner member-pivot window and an inner member-alignment feature, and inserting the inner member into an outer member with an outer member-pivot window and an outer member-alignment feature; wherein the transmitter carrier assembly comprises an insertion device, a bias member comprising an end feature and a locking feature, a pivot member including an insertion device support feature and a bias member interface feature, and a transmitter carrier supporting structure defining a guide region configured to support the pivot member; wherein assembling comprises placing the insertion device into the pivot member insertion device support feature and into the guide region, and bending the bias member so the end feature contacts the bias member interface feature; and wherein when assembled axial motion presses the end feature against the pivot member with a first portion of a stroke causing axial movement and a second portion retracting via overlapping pivot windows, and upon completion the locking feature engages with the inner member-pivot window to prevent the bias member from retracting.
Deterministic insertion method with pivot prevention, staged pivot motion, and locking
A method of inserting a biosensor comprising placing an inserter apparatus in contact with an insertion site, pushing on the outer member to cause the bias member to push against the pivot member such that the pivot member is prevented from pivoting over a first portion of a stroke, continuing the first portion until the insertion portion of the insertion device contacts and enters the insertion site with a biosensor remaining inserted contacting interstitial fluid, performing a second portion of the stroke in which pivot motion causes the pivot member to pull on the insertion device to retract the insertion portion from the insertion site, and wherein at least a portion of the pivot motion occurs with the first pivot window of the outer member overlapping the second pivot window of the inner member and during pivot motion an end portion of the pivot member enters the first pivot window by way of the second pivot window; and upon completion of the second portion, the locking feature of the bias member engages with the second pivot window to prevent the bias member from retracting and thereby prevent pivoting after insertion.
Across the independent claims, the inventive concept is an outer/inner member inserter with first and second pivot windows, a bias-member-driven two-portion stroke where pivoting/retraction occurs based on overlap of pivot windows, and a bias-member locking feature that engages a pivot window to prevent post-insertion pivoting.
Stated Advantages
Documented Applications
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