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KR-102962361-B1 - Introductory needle and catheter system including such needle

KR102962361B1KR 102962361 B1KR102962361 B1KR 102962361B1KR-102962361-B1

Abstract

A catheter system (10) for reducing the risk of vascular perforation. The catheter system includes a catheter adapter, and the catheter adapter includes a proximal end, a distal end, and a lumen extending between them. The catheter system includes a catheter (40) extending distally from the distal end of the catheter adapter. The catheter system includes an introductory needle (12) extending through the catheter (40). The introductory needle (12) includes a sharp distal tip (24) and a primary bevel (22) extending from the outer edge (20) of the introductory needle (12) to the sharp distal tip (24). The outer edge (20) is parallel to the central axis (16) of the introductory needle (12) and aligned with the sharp distal tip (24). The primary bevel (22) includes a primary bevel angle with respect to the central axis (16). The primary slope angle is 20° to 33°.

Inventors

  • 마 이핑
  • 스토키 데이비드
  • 바시아노 크리스토퍼 앤소니
  • 래드마허 마커스

Assignees

  • 백톤 디킨슨 앤드 컴퍼니

Dates

Publication Date
20260511
Application Date
20201111
Priority Date
20201109

Claims (20)

  1. It is a catheter system designed to reduce the risk of vascular perforation, and: A catheter adapter comprising a proximal end, a distal end, and a lumen extending between them; A catheter extending distally from the distal end of a catheter adapter; and It includes an introductory needle extending through a catheter, and the introductory needle is: A sharp distal tip; and A primary slope extending from the outer edge of the introductory needle to a sharp distal tip, wherein the primary slope is straight, the outer edge is parallel to the central axis of the introductory needle and aligned with the sharp distal tip, the primary slope includes a primary slope angle with respect to the central axis, and the primary slope angle is 20° to 33°, and The introductory needle is: It further includes a first cut and a second cut extending proximally from the primary slope to an opposing outer edge directly opposite the outer edge, respectively, wherein the opposing outer edge is parallel to the central axis and the outer edge, and A catheter system in which the first cut intersects the plane of the primary slope at the first intersection line, and the secondary angle between the first intersection line and the reference line of the introductory needle is 18° to 26° at an equal angle of 30/60.
  2. In paragraph 1, A catheter system with a primary slope angle of 22.2°.
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  5. In paragraph 1, A catheter system with a secondary angle of 22°.
  6. In paragraph 5, A catheter system with a primary slope angle of 22.2°.
  7. In paragraph 1, A catheter system in which the first cut is flat and the second cut is flat.
  8. It is an introductory needle: A sharp distal tip; and A primary slope extending from the outer edge of the introductory needle to a sharp distal tip, wherein the outer edge is parallel to the central axis of the introductory needle and aligned with the sharp distal tip, and the primary slope includes a primary slope angle with respect to the central axis, wherein the primary slope angle is 20° to 33°, and The primary slope is straight, and It further includes a first cut and a second cut extending proximally from the primary slope to an opposing outer edge directly opposite the outer edge, wherein the opposing outer edge is parallel to the central axis and the outer edge, and An introductory needle in which the first cut intersects the plane of the primary slope at the first intersection line, and the secondary angle between the first intersection line and the reference line of the introductory needle at an equal angle of 30/60 is 18° to 26°.
  9. In paragraph 8, Introductory needle with a primary slope angle of 22.2°.
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  12. In paragraph 8, Introductory needle with a secondary angle of 22°.
  13. In Paragraph 12, Introductory needle with a primary slope angle of 22.2°.
  14. In paragraph 8, An introductory needle in which the first cut is flat and the second cut is flat.
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Description

Introductory needle and catheter system including such needle Catheters are commonly used to infuse fluids into a patient's vascular structure. For example, catheters can be used to infuse normal saline, various medications, and total parenteral nutrition. The catheter may include a peripheral venous ("IV") catheter. In this case, the catheter may be mounted on an inducer needle having a sharp distal tip. The catheter and inducer needle may be assembled such that the distal tip of the inducer needle extends beyond the distal tip of the catheter, with the bevel of the needle facing away from the patient's skin. The catheter and inducer needle are generally inserted through the skin into the patient's vascular structure at a small angle. To verify the proper placement of the inducer needle and/or catheter within the vessel, clinicians typically check for a "flashback" of blood within the catheter system's flashback chamber. Once the placement of the inducer needle is confirmed, the clinician can remove the inducer needle to leave the catheter in place for subsequent fluid infusion. During catheter insertion, if the clinician advances the inducer needle too far, the blood vessel may be punctured. More specifically, if the inducer needle enters the upper part of the blood vessel and inadvertently penetrates the lower part as well, the vessel may be punctured by the inducer needle. Penetrating the blood vessel can be painful for the patient and may increase the risk of bleeding, hematoma, infection, and tissue damage. Additionally, fluids and medications may be injected into the extravascular space rather than into the blood vessel. In response to the puncture, the inducer needle may be withdrawn, and the clinician may perform additional needle insertion, which may reduce patient satisfaction. The subject matter claimed herein is not limited to embodiments that address any disadvantage or operate only in environments such as those described above. Instead, this background is provided merely to describe an exemplary technical field in which some of the embodiments described herein may be practiced. Exemplary embodiments will be described and explained with additional specificity and detail through the use of the attached drawings. FIG. 1 is a top perspective view of an exemplary needle assembly illustrating an exemplary introductory needle according to some embodiments. FIG. 2 is a top cross-sectional view of an exemplary catheter system according to some embodiments. FIG. 3 is an enlarged upper perspective view of the distal end of a catheter system according to some embodiments. FIG. 4 is a side view of an exemplary distal end of an introductory needle of a catheter system according to some embodiments. FIG. 5a is a cross-sectional view of the distal end of an introductory needle taken along line 5-5 of FIG. 4 according to some embodiments. FIG. 5b is a 30/60 equal angle of the distal end of the introductory needle according to some embodiments. FIG. 5c is a distal end view of an introductory needle illustrating an isometric view of FIG. 5b according to some embodiments. FIG. 6 is an enlarged top view of an exemplary bevel of an introductory needle according to some embodiments. FIG. 7a is a side view of an exemplary distal end of an introductory needle according to some embodiments. FIG. 7b is a side view of another exemplary distal end of an introductory needle according to some embodiments. FIG. 8 is a side view of another exemplary distal end of an introductory needle according to some embodiments. FIG. 9 is a table illustrating the relationship between the needle tip geometry, overall peak force, and initial peak force according to some embodiments. Now, referring to FIG. 1, in some embodiments, the vascular access device (10) may include a needle (12). In some embodiments, the needle (12) may be configured to reduce the risk of penetrating the blood vessel. In some embodiments, the needle (12) may also facilitate penetrating the blood vessel so that the force for the needle (12) to penetrate the patient's skin and blood vessel is not significantly increased beyond the force of a normal needle tip. As illustrated in FIG. 1, in some embodiments, the needle (12) may extend distally from the needle hub (13). In some embodiments, the needle (12) may include a shaft (14) which may be cylindrical or largely cylindrical. In some embodiments, a central axis (16) may extend through the center of the shaft (14). In some embodiments, the proximal end (18) of the needle (12) or the shaft (14) may be fixed within the needle hub (13). In some embodiments, the proximal end (18) of the needle (12) may include an opening, which may facilitate the flow of blood into the needle hub (13) for flashback and/or blood collection purposes. In some embodiments, the shaft (14) may include an outer edge (20) which may be positioned along the length of the shaft (14) up to the proximal end (18). In some embodiments, the distal end of