Method and device for puncture of insertion needle into subcutaneous fatty tissue

• US 9,295,418 B2
• Filed: 01/09/2013
• Issued: 03/29/2016
• Est. Priority Date: 07/10/2010
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Deck, Frank, Ebert, Karl-Peter
• Primary Examiner(s): ALEMAN, SARAH WEBB
• Application Number:
  US13/737,661
• Publication Number:
  US 20130131467A1
• Time in Patent Office: 1,175 Days
• Field of Search: 606181-185, 604/44, 604/264, 604/272, 604/506
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• 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 2017/3407 including a base for support on the body
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• 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: 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
• CPC Class Codes: A61M 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means

Abstract

An insertion device with an underside for placing on the skin of a patient, which has a recess for an insertion needle. The insertion device has means for forming a skin surface rising like a step or slope and facing towards the recess, preferably bearing on the recess. The means for forming the step or slope may include first and second pressure areas for pressing the skin with the recess for the needle located between the first and second pressure areas. The device may be configured whereby a downwardly extending cutting plane, in which the insertion needle lies, intersects the first pressure area in a first line and the second pressure area in a second line, and wherein the first line in the vicinity of the recess extends at a greater height than the second line. At least one of the two pressure areas may be a strip.

Claims

1. An insertion device for use with a patient, the insertion device defining a vertical direction, a longitudinal direction perpendicular to the vertical direction and a lateral direction perpendicular to both the vertical and longitudinal directions, the insertion device comprising:

a lower side adapted to be placed on the skin of the patient and an upper side positioned vertically opposite the lower side, the lower side including a recess for an insertion needle—

generally extending in the longitudinal direction and—

held by the insertion device;

means for forming a skin area rising in the manner of a step or slope facing the recess; and

wherein the means for forming the skin area rising in the manner of a step or slope includes a first pressure area and a second pressure area adapted to be pressed against the skin, wherein the recess for the insertion needle is located between the first pressure area and the second pressure area, and wherein a sectional plane which extends from the upper side in a downward vertical direction to the lower side and in which the insertion needle is located intersects the first pressure area in a first line and the second pressure area in a second line, and wherein the first line runs proximate the recess at a greater vertical height than the second line;

wherein at least one of the two pressure areas is a longitudinally extending strip having a longitudinal length at least twice as great as a lateral width of the strip; and

wherein the insertion device broadens in each lateral direction in an upward vertical direction, starting at opposite lateral sides of the lower side.

2. The insertion device according to claim 1 wherein the first pressure area is adapted to be in contact with the skin vertically above the insertion needle when the insertion needle is in a protruding state which is reached at the end of a feed motion when a puncture is made.

3. The insertion device according to claim 2 wherein the strip has a lateral width of less than 1 cm.

4. The insertion device according to claim 2 wherein the second pressure area is a generally planar surface arranged between two supporting areas, the two supporting areas being defined by a pair of inclined surfaces which extend from opposite sides of the second pressure area both laterally away from the second pressure area and vertically upwardly.

5. The insertion device according to claim 1 wherein the strip has a lateral width of less than 1 cm.

6. The insertion device according to claim 5 wherein the second pressure area is a generally planar surface arranged between two supporting areas, the two supporting areas being defined by a pair of inclined surfaces which extend from opposite sides of the second pressure area both laterally away from the second pressure area and vertically upwardly.

7. The insertion device according to claim 1 wherein the second pressure area is a generally planar surface arranged between two supporting areas, the two supporting areas being defined by a pair of inclined surfaces which extend from opposite sides of the second pressure area both laterally away from the second pressure area and vertically upwardly.

8. The insertion device according to claim 7 wherein the second pressure area is a longitudinally extending strip.

9. The insertion device according to claim 1 wherein the means for forming the step- or slope-like skin area comprise an adhesive area adapted to be adhered to the skin to be formed.

10. The insertion device according to claim 1 wherein the means for forming the step- or slope-like skin area of the skin comprises at least two holding parts which are movable against each other in order to form the skin.

11. The insertion device according to claim 1 wherein the insertion device is composed of first and second partial bodies wherein the first and second partial bodies are movable against each other and a vertically and longitudinally extending seam extends between the first and second partial bodies and through the recess and wherein relative movement of the first and second partial bodies facilitates removal of the insertion device after an insertion and each of the first and second partial bodies defines at least a portion of at least one of the first and second pressure areas.

12. The insertion device according to claim 11 wherein the first and second partial bodies are held to each other by magnetic force.

13. The insertion device according to claim 1 wherein the insertion needle is held in the insertion device at a slanted angle in the vertically downward direction relative to the longitudinal direction.

14. The insertion device according to claim 10 wherein the first and second pressure areas are planar and disposed parallel with each other and the longitudinal direction.

15. The insertion device according to claim 1 wherein at least the second pressure area is a strip.

16. The insertion device according to claim 1 wherein the two pressure areas form a strip-shaped area with which the insertion device acts on the skin of a patient when the insertion device is pressed onto the skin.

17. The insertion device according to claim 1 wherein the first and second pressure areas are planar and disposed parallel with each other.

18. An insertion device for use with a patient, the insertion device defining a vertical direction, a longitudinal direction perpendicular to the vertical direction and a lateral direction perpendicular to both the vertical and longitudinal directions, the insertion device comprising:

a lower side adapted to be placed on the skin of the patient and an upper side positioned vertically opposite the lower side, the lower side including a recess for an insertion needle held by the insertion device;

means for forming a skin area rising in the manner of a step or slope facing the recess; and

wherein the means for forming the skin area rising in the manner of a step or slope includes a first pressure area and a second pressure area adapted to be pressed against the skin, wherein the recess for the insertion needle is located between the first pressure area and the second pressure area, and wherein a sectional plane which extends from the upper side in a downward vertical direction to the lower side and in which the insertion needle is located intersects the first pressure area in a first line and the second pressure area in a second line, and wherein the first line runs proximate the recess at a greater vertical height than the second line;

wherein at least one of the two pressure areas is a longitudinally extending strip having a longitudinal length at least twice as great as a lateral width of the strip; and

wherein the insertion device broadens in each lateral direction in an upward vertical direction, starting at opposite lateral sides of the lower side; and

at least one linear guide and a slide body slidingly disposed on the linear guide;

the slide body being adapted to support the insertion needle wherein sliding advancement of the slide body advances the insertion needle in a puncture movement.

19. The insertion device according to claim 18 wherein the linear guide comprises a plurality of guide rods.