Atraumatic insertion of a subcutaneous device

• US 6,936,006 B2
• Filed: 03/19/2003
• Issued: 08/30/2005
• Est. Priority Date: 03/22/2002
• Status: Expired due to Fees

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Sabra, Mads C.
• Primary Examiner(s): Nasser, Robert L.
• Assistant Examiner(s): Mallari, Patricia C
• Application Number:
  US10/393,194
• Publication Number:
  US 20030225361A1
• Time in Patent Office: 895 Days
• Field of Search: 600/300, 600/309, 600/327, 600/332, 600/345, 600/373, 600/381, 600/386, 600/478, 600/486, 600/562, 600/576.581, 600/325, 600/573, 600/576, 600/581, 604/57, 604/59, 604/93.01, 604/500, 604/115, 604/264, 604272-274, 604/158, 604/160, 604/161, 604/27, 604/36, 606/108, 606/129, 204/403.01
• US Class Current: 600/300
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61M 25/065 Guide needles

Abstract

The invention relates to a concept for placing a subcutaneous device such as a sensor at a selected site within the body of a patient, e.g. to obtain blood glucose readings. In a first aspect, an insertion needle comprises an oblong needle body and a distal end portion, the distal end portion having a pointed distal tip allowing the needle to be introduced subcutaneously and a distally facing generally smooth surface, the body comprising along a portion thereof a longitudinal groove adapted to at least partially accommodate the subcutaneous device. In a second aspect, a combination of an insertion needle and a subcutaneous device form an oblong body portion and a distal end portion formed by either of the members or in combination by the two members, the distal end portion having a pointed distal tip and a distally facing generally smooth surface. By the above configuration, a concept is provided reducing the severity of the body response following transcutaneous placement of a device as well as reducing the pain associated with the insertion.

Claims

1. A method for inserting a subcutaneous device, comprising the steps of:

providing an assembly of an insertion needle and a subcutaneous device, the insertion needle comprising a pointed distal tip and a recess with an outwardly and proximally facing ramp, a distal portion of the subcutaneous device being arranged in the recess,

inserting the insertion needle and the subcutaneous device subcutaneously,

withdrawing the insertion needle relative to the subcutaneous device, the ramp thereby displacing the subcutaneous device laterally.

2. An assembly comprising an insertion needle in combination with a displaceable sensor device comprising at least one sensor element, the insertion needle comprising:

a distal end portion having a pointed distal tip and a distally facing generally smooth surface,

a needle body comprising along a portion thereof, a longitudinal recess terminating in the vicinity of the distal end portion and having a distal ramp facing outwardly and proximally relative to the needle body,

the recess being adapted to at least partially accommodate the sensor device,

wherein the sensor device is displaced laterally by the ramp when the insertion needle is moved proximally relative to the subcutaneous device.

3. An assembly comprising an insertion needle in combination with a displaceable flexible sensor device, the insertion needle comprising:

a distal end portion having a pointed distal tip and a distally facing generally smooth surface,

a needle body comprising along a portion thereof, a longitudinal recess terminating in the vicinity of the distal end portion and having a distal ramp facing outwardly and proximally relative to the needle body,

the recess being adapted to at least partially accommodate the flexible sensor device,

wherein the flexible sensor device is displaced laterally by the ramp when the insertion needle is moved proximally relative to the subcutaneous device.

4. A transcutaneous sensor insertion set, comprising:

a mounting base adapted for mounting onto a patient'"'"'s skin,

a flexible sensor device having a proximal portion carried by the base and a distal portion protruding from the mounting base, the distal portion comprising at least one sensor element,

an insertion needle comprising a distal end portion having a pointed distal tip and a distally facing generally smooth surface, and a needle body comprising along a portion thereof, a longitudinal recess terminating in the vicinity of the distal end portion and having a distal ramp facing outwardly and proximally relative to the needle body, the insertion needle extending from the mounting base and supporting the distal sensor portion for transcutaneously placing the distal sensor portion when the mounting base is placed against a patient'"'"'s skin,

wherein the insertion needle and the distal sensor portion in combination form an insertion body, the insertion needle being arranged for sliding withdrawal from the sensor device and the mounting base, and

wherein the distal sensor portion is displaced laterally by the ramp when the insertion needle is withdrawn.