PUNCTURE METHOD, INCISION NEEDLE, PUNCTURE NEEDLE, NEEDLE CAP AND INSTRUMENT FOR BLOOD PURIFICATION TREATMENT

• US 20110295152A1
• Filed: 05/25/2011
• Published: 12/01/2011
• Est. Priority Date: 05/25/2010
• Status: Abandoned Application

• Current Assignee: Asahi Kasei Medical Co., Ltd. (Asahi Kasei Corporation), Nextier Corporation
• Original Assignee: Asahi Kasei Kuraray Medical Company Limited (Asahi Kasei Corporation), Nextier Corporation
• Inventors: SASAKI, Masatomi, MARUYAMA, Yasuyo, SHIONOYA, Yukie, SHINZATO, Toru
• Application Number:
  US13/115,275
• Publication Number:
  US 20110295152A1
• Time in Patent Office: Days
• US Class Current: 600/573
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• 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 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150541 Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
• CPC Class Codes: A61B 5/150587 by friction fit
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/15074 Needle sets comprising wings, e.g. butterfly type, for ease of handling
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61M 25/065 Guide needles

Abstract

The present invention is a method of puncturing a shunt blood vessel, using a incision needle having a pointed extremity that protrudes apically from a hypothetical angled plane formed by cutting straight through the tip of the needle at an angle, wherein the pointed extremity of the incision needle is inserted into a shunt blood vessel, thereby forming a reverse U-shaped incision on the surface of the shunt blood vessel, with the apex of the incision being on the bottom side in the direction of insertion.

Claims

1. A method of puncturing a shunt blood vessel, comprising a step of puncturing a shunt blood vessel with a tubular or cylindrical incision needle and thereby forming an incision on a surface of the shunt blood vessel, wherein

the incision needle has an angled end face at the tip of the needle, and the tip of the angled end face has a pointed extremity that protrudes apically from a hypothetical angled plane formed by cutting straight through the tip of the needle at an angle, and

the step of forming the incision comprises:

a step of arranging the incision needle so that the angled end face faces the skin;

a step of puncturing the skin with the pointed extremity of the incision needle and inserting the needle toward the shunt blood vessel to thereby form a puncture route; and

a step of inserting the pointed extremity of the incision needle into the shunt blood vessel to thereby form a reverse U-shaped incision that opens towards the front side, with the apex of the incision being on the far side in the direction of insertion.

2. The puncture method according to claim 1, wherein the incision needle is a needle in which the pointed extremity is bent towards the central axis of the needle.

3. The puncture method according to claim 1, wherein the incision needle is a needle in which a cutting face is formed on at least a part, in the angled end face, that includes the pointed extremity.

4. The puncture method according to claim 3, wherein the incision needle has the cutting face extending from the pointed extremity to the angled surface of the angled end face.

5. The puncture method according to claim 1, wherein the incision needle has a reverse cutting face on the reverse surface of the angled end face.

6. The puncture method according to claim 5, wherein the incision needle has the reverse cutting face on at least the pointed extremity.

7. The puncture method according to claim 5, wherein the incision needle has the reverse cutting face on both sides of the reverse surface of the angled end face formed posterior to the pointed extremity.

8. The puncture method according to claim 1, wherein the incision needle has another pointed extremity pointing apically behind the pointed extremity of the angled end face.

9. The puncture method according to claim 1, wherein the incision needle has a groove, on the reverse surface, for accepting blood of the shunt blood vessel from the tip of the angled end face.

10. The puncture method according to claim 1, further comprising a step of penetrating the puncture route in the skin with a puncture needle and inserting the puncture needle into the shunt blood vessel through the incision, after formation of the reverse U-shaped incision.

11. The puncture method according to claim 10, wherein

the puncture needle has a tubular part with an angled end face angled with respect to the needle axis and a protruding part that protrudes forwards from the tip of the angled end face of the tubular part, and wherein

the tip of the protruding part is narrower than the tubular part, and is curved convexly towards the front.

12. The puncture method according to claim 11, wherein the curvature radius of the tip of the protruding part of the puncture needle is smaller than the curvature radius of the tip of the angled end face.

13. The puncture method according to claim 11, wherein the inclination angle of the angled end face relative to the protruding direction of the protruding part of the puncture needle is less than 60°

.

14. The puncture method according to claim 10, further comprising a step of removing a scab formed at the entrance of the puncture route on the skin surface with a needle cap of the puncture needle before inserting the puncture needle into the puncture route.

15. The puncture method according to claim 14, wherein

the needle cap has a hollow holding part for holding the needle and a scab removal part at the tip of the holding part, and

the scab removal part is formed from a circular arc-shaped outer surface that curves around the needle insertion axis and an inner surface located inside the outer surface, and in the scab removal part a sharp top edge with a width in the direction of the needle insertion axis is formed by the outer surface and inner surface.

16. The puncture method according to claim 15, wherein

the scab removal part is formed substantially in a crescent shape in cross-section, and

the angle formed by the arc of the outer surface and the arc of the inner surface at the top edge is 5°

to 89°

in this crescent shaped cross-section.

17. The puncture method according to claim 15, wherein a protruding part with a flat anterior surface protruding forwards on the outer side of the top edge is formed at the tip of the needle cap.

18. The puncture method according to claim 17, wherein

the protruding part of the needle cap is formed protruding forwards from the base of the tip on the center line passing between the left and right as seen from the front of the tip, and

the outer surface of the scab removal part extends, from the protruding part, outwards around the circumference of the tip, with the top edge being formed at the farthest periphery of this outer surface.

19. The puncture method according to claim 18, wherein the scab removal part is formed on both the left and right sides of the protruding part.

20. The puncture method according to claim 15, wherein the scab removal part of the needle cap is formed on both left and right sides of the center line as seen from the front side of the tip, and the top edges on both sides are formed to be reverse to each other around the circumference of the tip.

21. The puncture method according to claim 15, wherein the inner surface of the needle cap curves convexly towards the outer surface.

22. The puncture method according to claim 14, wherein

a scab removal part is formed at the tip of the needle cap,

the scab removal part has a flat outer face parallel to the needle insertion axis and an inner surface located inside the outer face, and

a sharp top edge with a width in the direction of the needle insertion axis is formed by the outer face and the inner surface.

23. The puncture method according to claim 22, wherein a protruding part with a flat anterior surface protruding forwards on the outside of the sharp top edge is formed on the tip of the needle cap.

24. The puncture method according to claim 23, wherein

the protruding part of the needle cap is formed protruding forward from the base of the tip along the center line passing between the left and right as seen from the front side of the tip, and

the outer face of the scab removal part is formed at the side of the protruding part of the needle cap, and the top edge is formed at the periphery of the outer face furthest from the protruding part.

25. The puncture method according to claim 23, wherein the scab removal part is formed on both the left and right sides of the protruding part of the needle cap.

26. The puncture method according to claim 22, wherein the scab removal part is formed on both left and right sides of the center line as seen from the front side of the tip, and the top edges on both sides are formed on reverse sides each other to the left and right of the protruding part.

27. The puncture method according to claim 22, wherein the inner surface of the needle cap is curved convexly outwards.

28. The puncture method according to claim 15, wherein the inner surface tapers in the direction of the needle insertion axis so that the scab removal part grows thinner towards the front.

29. The puncture method according to claim 15, wherein the needle cap is used for a needle for puncturing during blood purification treatment.

30. The puncture method according to claim 15, wherein the needle cap is used for a needle for puncturing during drug administration or blood withdrawal.

31. A method of puncturing a shunt blood vessel with a puncture needle through a puncture hole formed by incision in the surface of a shunt blood vessel, wherein

the puncture needle is a needle having a tubular part with an angled end face angled with respect to the needle axis and a protruding part that protrudes forwards linearly from the tip of the angled end face of the tubular part, with the tip of the protruding part being narrower than the tubular part and being curved convexly in the front, and

the method of puncturing comprises a step of inserting the puncture needle in the shunt blood vessel through the puncture hole formed by incision starting with the protruding part.

32. A method of puncturing a shunt blood vessel, comprising a step of removing a scab formed at an entrance to a puncture route on a skin surface with a needle cap to be mounted on a puncture needle, and a step of puncturing the shunt blood vessel with the puncture needle after removal of the scab, wherein

the needle cap is a needle cap having a hollow holding part for holding the needle and a scab removal part on the tip of the holding part, with the scab removal part being formed from a circular arc-shaped outer surface curving around the needle insertion axis and an inner surface located inside the outer surface, and the needle cap further having a sharp top edge with a width in the direction of the needle insertion axis formed by the outer surface and inner surface, and

the scab is removed with the scab removal part of the needle cap.

33. A tubular or cylindrical incision needle for puncturing a shunt blood vessel and forming an incision on the surface of a shunt blood vessel, comprising an angled end face at the tip of the needle, wherein

the tip of the angled end face has a pointed extremity protruding apically from a hypothetical angled plane formed by cutting straight through the tip of the needle at an angle, and

the pointed extremity is curved towards the central axis of the needle,

cutting faces are formed on at least a part of the angled end face that includes the pointed extremity,

reverse cutting faces are formed on at least a part of the reverse surface of the angled end face that includes the pointed extremity, and

the foremost edge of the pointed extremity is formed by the cutting faces arranged symmetrically with the foremost edge therebetween, while the reverse cutting face is disposed not at the foremost edge, but arranged symmetrically with the center of the pointed extremity therebetween.

34. The incision needle according to claim 33, wherein the distance between the tip of the pointed extremity and the outer surface of the needle body is 6% to 50% of the outer diameter of the needle body.

35. A puncture needle for puncturing a shunt blood vessel through a puncture hole formed by incision in the surface of a shunt blood vessel, comprising:

a tubular part having an angled end face angled relative to the needle axis; and

a protruding part that protrudes forwards from the tip of the angled end face of the tubular part, wherein

the protruding part is narrower at the tip than the tubular part and has a convex curve at the front, and

the radius of the protruding part is 200 μ

m or more.

36. The puncture needle according to claim 35, wherein the curvature radius Re of the tip of the protruding part and the radius Ro of the outer diameter of the tubular part are in the relationship of 0.1×

Ro≦

Re<

1.0×

Ro.

37. A needle cap for removing a scab at the entrance to a puncture route in a skin surface, comprising:

a hollow holding part for holding a needle; and

a scab removal part at the tip of the holding part, wherein

the scab removal part is formed from a circular arc-shaped outer surface curving around the needle insertion axis and an inner surface located inside the outer surface, and has a sharp top edge that is formed from this outer surface and inner surface and has a width in the direction of the needle insertion axis, and

the scab removal part is formed substantially in a crescent shape in cross-section, and the angle formed by the arc of the outer surface and the arc of the inner surface at the top edge in this crescent cross-section is 5°

to 89°

.

38. The needle cap according to claim 37, wherein the length of the arc of the outer surface of the crescent cross-section is 5 to 50% of the maximum outer diameter of the holding part.

39. A blood purification instrument capable of constituting part of a blood purification circuit, comprising the needle cap according to claim 37, a needle inserted in this needle cap, a tube with this needle connected to a tip thereof, and a connecting part for connecting the posterior end of this tube to another tube.