Injection needle assembly and drug injection device

• US 9,566,393 B2
• Filed: 12/17/2013
• Issued: 02/14/2017
• Est. Priority Date: 01/30/2009
• Status: Active Grant

• Current Assignee: Terumo Kabushiki Kaisha
• Original Assignee: Terumo Kabushiki Kaisha
• Inventors: Iwase, Yoichiro, Koiwai, Kazunori, Tanaka, Tetsuo, Oomori, Sayaka
• Primary Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US14/108,699
• Publication Number:
  US 20140107578A1
• Time in Patent Office: 1,155 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

To securely position a needle tip and a blade face of a needle tube inserted into the skin in a predetermined site of a living body, such as the upper layer of skin, an injection needle assembly includes a needle tube having a needle tip capable of puncturing a living body, a hub holding the needle tube, a stabilizer, and a guide portion. The stabilizer is formed in a tubular shape surrounding the circumference of the needle tube, and an end face is pressed against the skin, and thereby a raised portion of the skin is formed in a tube hole. The guide portion is arranged on the stabilizer, and is adapted to recognize a press-in distance y of the stabilizer to the skin.

Claims

1. An injection needle assembly comprising:

a needle tube, smaller than 26 G in size, having a needle tip capable of puncturing a living body and a bevel length of 1.4 mm or shorter so as to be placed in a skin upper layer;

a hub for holding the needle tube;

a stabilizer formed in a tubular shape surrounding the circumference of the needle tube and having an end face that contacts a skin of the living body when puncturing the living body with the needle tube; and

a guide portion provided on the stabilizer for guiding, by being contacted with the skin, a pressing parameter applied from the needle tube and the stabilizer to the living body when puncturing the living body with the needle tube.

2. The injection needle assembly according to claim 1,

wherein the stabilizer is a skin deformer adapted to form a raised portion of the skin in a tube hole thereof by pressing the end face of the stabilizer against the skin;

wherein the pressing parameter is a press-in distance of the skin deformer to the skin; and

wherein the guide portion is a distance recognizer adapted to recognize the press-in distance.

3. The injection needle assembly according to claim 2, wherein the distance recognizer is a stepped portion formed in an outer circumferential surface of the skin deformer.

4. The injection needle assembly according to claim 2, wherein the distance recognizer is a flange projecting from an outer circumferential surface of the skin deformer.

5. The injection needle assembly according to claim 3, wherein the distance recognizer has a contact surface parallel to the end face of the skin deformer, the contact surface being caused to recognize, by being brought into contact with the skin, the press-in distance of the skin deformer to the skin.

6. The injection needle assembly according to claim 5, wherein the contact surface of the distance recognizer is continuous with the outer circumferential surface of the skin deformer, and a recognizer length, which is a length of the contact surface of the distance recognizer in a direction perpendicular to the outer circumferential surface of the skin deformer, is in a range of 0.5-5.0 mm.

7. The injection needle assembly according to claim 6, wherein the tube hole of the skin deformer is formed in circular shape.

8. The injection needle assembly according to claim 7, wherein a diameter of the tube hole of the skin deformer is in a range of 8-28 mm.

9. The injection needle assembly according to claim 8, wherein the diameter of the tube hole of the skin deformer is in a range of 11-14 mm.

10. The injection needle assembly according to claim 9, wherein, in the case where the recognizer length is set in a range of 3.0-5.0 mm, if z represents the height of the raised portion of the skin and y represents the distance between the end face of the skin deformer and the distance recognizer, then z and y satisfy the relation defined by the following expression:

z=0.1y+0.1.

11. The injection needle assembly according to claim 1, further comprising an adjusting portion arranged around the needle tube, the adjusting portion having a needle-protruding surface from which the needle tip of the needle tube protrudes,

wherein the pressing parameter is a pressing force.

12. The injection needle assembly according to claim 11, wherein the pressing force is in a range of 0.5-20 N.

13. The injection needle assembly according to claim 11, wherein the guide portion has a stepped portion formed in an outer circumferential surface of the stabilizer and substantially perpendicular to the outer circumferential surface of the stabilizer.

14. The injection needle assembly according to claim 11, wherein the guide portion is a flange projecting substantially perpendicularly from an outer circumferential surface of the stabilizer.

15. The injection needle assembly according to claim 13, wherein the stabilizer is formed in a circular tube shape.

16. The injection needle assembly according to claim 15, wherein, in the case where the internal diameter of the stabilizer is set in a range of 12-14 mm, if y represents the distance between a contact surface of the guide portion and the end face of the stabilizer, the contact surface and the end face contacting the skin, and x represents a guide portion length which is a length of the guide portion from the stabilizer in a substantially perpendicular direction, then y and x satisfy the relation defined by the following expression:

1.0 Ln(x)+1.2<

y<

3.1 Ln(x)+3.2.

17. The injection needle assembly according to claim 15, wherein, in the case where the internal diameter of the stabilizer is set to 11 mm, the distance between a contact surface of the guide portion and the end face of the stabilizer, the contact surface and the end face contacting the skin, is set in a range of 0.75-2.6 mm when a guide portion length which is a length of the guide portion from the stabilizer in a substantially perpendicular direction is 0.5 mm.

18. The injection needle assembly according to claim 11, wherein the needle-protruding surface of the adjusting portion is formed such that the distance from a circumferential edge of the needle-protruding surface to a circumferential surface of the needle tube is in a range of 0.3-1.4 mm.

19. The injection needle assembly according to claim 11, wherein a distance from an inner wall of the stabilizer to an outer circumferential surface of the adjusting portion is set in a range of 4-15 mm.

20. The injection needle assembly according to claim 1, wherein the guide portion projects radially from an outer circumferential surface of the stabilizer and contacts the skin at a contact surface which is parallel to the end face of the stabilizer.

21. A drug injection device comprising:

a needle tube, smaller than 26 G in size, having a needle tip capable of puncturing a living body and a bevel length of 1.4 mm or shorter so as to be placed in a skin upper layer;

a hub for holding the needle tube;

a syringe connected to the hub;

a stabilizer formed in a tubular shape surrounding the circumference of the needle tube and having an end face that contacts a skin of the living body when puncturing the living body with the needle tube; and

a guide portion provided on the stabilizer for guiding, by being contacted with the skin, a pressing parameter applied from the needle tube and the stabilizer to the living body when puncturing the living body with the needle tube.

22. The drug injection device according to claim 21, wherein the guide portion projects radially from an outer circumferential surface of the stabilizer and contacts the skin at a contact surface which is parallel to the end face of the stabilizer.