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BR-112021013954-B1 - Catheter system with confirmation of catheter placement inside a vein.

BR112021013954B1BR 112021013954 B1BR112021013954 B1BR 112021013954B1BR-112021013954-B1

Abstract

CONFIRMATION OF CATHETER PLACEMENT WITHIN A VEIN. A catheter system may include a catheter adapter, which may include a distal end and a proximal end. The catheter system may include a catheter, which may include a distal end, a proximal end, a catheter lumen extending through the distal end of the catheter and the proximal end of the catheter, and an inner surface forming the catheter lumen. The catheter may extend distally from the distal end of the catheter adapter. The distal end of the catheter may include one or more orifices. The distal end of the catheter may include one or more channels. The orifices and/or channels may facilitate visualization of blood return discharge, indicating that the catheter is placed within a patient's vein.

Inventors

  • Yiping Ma
  • S. Ray Isaacson
  • WESTON F. HARDING
  • Joseph Spataro
  • Huy Tran
  • JONATHAN KARL BURKHOLZ
  • Mohankumar Natesan
  • KIAT JIN CHENG
  • Kathryn Willybiro

Assignees

  • BECTON, DICKINSON AND COMPANY

Dates

Publication Date
20260310
Application Date
20200116
Priority Date
20200114

Claims (15)

  1. 1. Catheter system (10) comprising: a catheter adapter (16), comprising a distal end (18) and a proximal end (20); a catheter (22), comprising a distal end (24), a proximal end (26), a catheter lumen (62) extending through the distal end (24) of the catheter (22) and the proximal end (26) of the catheter (22) and an inner surface (64) forming the catheter lumen (62), wherein the catheter (22) extends distally from the distal end (18) of the catheter adapter (16), wherein the distal end (24) of the catheter (22) comprises an orifice (66); an introducer needle (30) extending through the catheter (22), wherein the introducer needle (30) comprises a distal end (31), a proximal end, an introducer needle lumen (58) extending through the distal end (31) of the introducer needle (30) and the proximal end of the introducer needle (30) and an inner surface (60) forming the introducer needle lumen (58), wherein the distal end (31) of the introducer needle (30) comprises a sharp distal tip (48) and a notch (88) proximal to the sharp distal tip (48), wherein the notch (88) provides a fluid path from the introducer needle (30) to a gap (68); the gap (68) disposed between an outer surface of the introducer needle (30) and the inner surface (64) of the catheter (22) and within the catheter lumen (62), wherein blood is configured to flow through the orifice (66) and into the gap (68) in response to placement of the introducer needle (30) in a vein; and CHARACTERIZED by the fact that it further comprises a sensor (80) that is embedded in the inner surface (64) of the catheter (22) at the distal end (24) of the catheter (22) within the gap (68) and aligned with the notch (88) of the introducer needle (30), wherein the sensor (80) is configured to detect that the distal end (31) of the introducer needle (30) is within the vein.
  2. 2. Catheter system (10), according to claim 1, CHARACTERIZED in that the gap (68) is annular.
  3. 3. Catheter system (10), according to claim 1, CHARACTERIZED in that the sensor (80) is a bioimpedance sensor.
  4. 4. Catheter system (10), according to claim 1, CHARACTERIZED in that the sensor (80) is a pressure sensor.
  5. 5. Catheter system (10), according to claim 1, CHARACTERIZED in that the sensor (80) is a capacitance sensor.
  6. 6. Catheter system (10), according to claim 1, CHARACTERIZED in that the sensor (80) is an infrared sensor.
  7. 7. Catheter system (10), according to claim 1, CHARACTERIZED in that it further comprises a plurality of other sensors (80), wherein the plurality of other sensors (80) is aligned with a chamfer of the introducer needle (30) and within the introducer needle lumen (58).
  8. 8. Catheter system (10), according to claim 1, CHARACTERIZED in that the sensor (80) embedded in the inner surface (64) of the catheter (22) is a single sensor (80), wherein the inner surface (64) of the catheter (22) comprises no more than the single sensor (80) embedded in the inner surface (64).
  9. 9. Catheter system (10) comprising: a catheter adapter (16), comprising a distal end (18) and a proximal end (20); a catheter (22), comprising a distal end (24), a proximal end (26), a catheter lumen (62) extending through the distal end (24) of the catheter (22) and the proximal end (26) of the catheter (22) and an inner surface (64) forming the catheter lumen (62), wherein the distal end (24) comprises a distal opening (56), wherein the catheter (22) extends distally from the distal end (18) of the catheter adapter (16), wherein the inner surface (64) of the catheter (22) comprises a plurality of channels (78) extending from the distal opening (56); an introducer needle (30) extending through the distal opening (56), wherein the introducer needle (30) comprises a distal end (31), a proximal end, an introducer needle lumen (58) extending through the distal end (31) of the introducer needle (30) and the proximal end of the introducer needle (30), and an inner surface (60) forming the introducer needle lumen (58), wherein the distal end (31) of the introducer needle (30) comprises a sharp distal tip (48); CHARACTERIZED in that it further comprises a bioimpedance sensor (80), wherein the bioimpedance sensor (80) comprises a first electrode (84a) and a second electrode (84b), wherein the second electrode (84b) is configured to be attached to a patient's skin; a gap (68) disposed between an outer surface of the introducer needle (30) and the inner surface (64) of the catheter (22) and within the catheter lumen (62), wherein blood is configured to flow through the plurality of channels (78), between the outer surface of the introducer needle (30) and the inner surface (64) of the catheter (22), and into the gap (68) in response to placement of the distal end (24) of the catheter (22) in a vein, wherein the first electrode (84a) is embedded in the inner surface (64) of the catheter (22) at the distal end (24) of the catheter (22) close to the gap (68).
  10. 10. Catheter system (10), according to claim 9, CHARACTERIZED in that the distal end (24) of the catheter (22) comprises an orifice (66) near the gap (68).
  11. 11. Catheter system (10), according to claim 9, CHARACTERIZED in that an outer surface of the distal end (31) of the introducer needle (30) comprises a fluid-communicating channel (90) with the gap (68).
  12. 12. Catheter system (10), according to claim 11, CHARACTERIZED in that the introducer needle (30) comprises a notch (88) proximal to the channel (90).
  13. 13. Catheter system (10), according to claim 12, CHARACTERIZED in that it further comprises an absorbent material (96) disposed within or near the notch (88).
  14. 14. Catheter system (10) comprising: a catheter adapter (16), comprising a distal end (18) and a proximal end (20); a catheter (22), comprising a distal end (24), a proximal end (26), a catheter lumen (62) extending through the distal end (24) of the catheter (22) and the proximal end (26) of the catheter (22) and an inner surface (64) forming the catheter lumen (62), wherein the catheter (22) extends distally from the distal end (18) of the catheter adapter (16), wherein the distal end (24) of the catheter (22) comprises a first orifice (66), a second orifice (66) proximal to the first orifice (66), and a distal opening (56); an introducer needle (30) extending through the distal opening (56), CHARACTERIZED in that the introducer needle (30) comprises a sharp distal tip (48), an annular wall (61) forming an introducer needle lumen (58), a first groove (103) and a second groove (103), wherein a distal end (104) of the first groove (103) is close to the first orifice (66), wherein a distal end (104) of the second groove (103) is close to the second orifice (66), wherein the first groove (103) and the second groove (103) are fluidly separated from the introducer needle lumen (58) by the annular wall (61); a first position indicator (50, 80, 88, 96) configured to indicate that the introducer needle (30) is inserted into a vein; and a second position indicator (66, 78, 80, 90, 98, 103, 108) configured to indicate that the catheter (22) is inserted into the vein.
  15. 15. Catheter system (10), according to claim 14, CHARACTERIZED in that a length of the first groove (103) extends proximal to the second orifice (66).

Description

PRECEDENTS [001] Catheters are commonly used for a variety of infusion therapies. For example, catheters can be used to infuse fluids, such as normal saline, various medications, and total parenteral nutrition, into a patient. Catheters can also be used to withdraw blood from the patient. [002] A common type of catheter is a peripheral intravenous catheter over a needle ("PIVC"). As the name suggests, the PIVC over a needle can be fitted onto an introducer needle with a sharp distal tip. The PIVC and introducer needle can be fitted so that the distal tip of the introducer needle extends beyond the distal tip of the PIVC with the bevel of the needle facing away from the patient's skin. The PIVC and introducer needle are usually inserted at a shallow angle through the skin into the patient's vein. [003] In order to verify proper placement of the introducer needle and/or PIVC in the blood vessel, a clinician usually confirms that there is "backflow" of blood. In more detail, in some cases, the introducer needle may include a notch. In response to the sharp distal tip of the introducer needle being positioned within the patient's vasculature, blood may flow proximally through an introducer needle lumen and exit the needle lumen through the notch. [004] Blood can then move proximally between an outer surface of the introducer needle and an inner surface of the PIVC, which may be transparent. Thus, the clinician can visualize the blood and thus confirm the placement of the introducer needle within the vasculature. Once needle placement has been confirmed, the clinician can temporarily occlude flow in the vein and remove the introducer needle, leaving the PIVC in place for future blood withdrawal and/or fluid infusion. [005] The subject matter claimed in this document is not limited to modalities that resolve any disadvantages or that operate only in environments such as those described above. Instead, this precedent is provided only to illustrate an example from the technology field where some implementations described herein can be practiced. SUMMARY [006] The present disclosure generally relates to vascular access devices and related systems and methods. In some embodiments, a catheter system may include a catheter adapter, which may include a distal end, a proximal end, and a catheter adapter lumen that extends through the distal end of the catheter adapter and the proximal end of the catheter adapter. In some embodiments, the catheter system may include a catheter, which may include a distal end, a proximal end, a catheter lumen that extends through the distal end of the catheter and the proximal end of the catheter, and an inner surface that forms the catheter lumen. In some embodiments, the catheter may extend distally from the distal end of the catheter adapter. [007] In some embodiments, the catheter system may include an introducer needle, which may extend through the catheter. In some embodiments, the introducer needle may include a sharp distal tip, which may be disposed distal to the distal end of the catheter. In some embodiments, the distal end of the catheter may include a distal opening, and the introducer needle may extend through the distal opening. [008] In some embodiments, the distal end of the catheter adapter may include one or more orifices. In some embodiments, the catheter system may include a gap disposed between an outer surface of the introducer needle and an inner surface of the catheter. In some embodiments, the gap may be disposed within the catheter lumen. In some embodiments, the gap may be in fluid communication with the orifices, so that, in response to the orifices being inserted into a vein, blood may flow through the orifices and into the gap. In some embodiments, all or part of the catheter may be transparent and the gap may include a viewing channel in which blood flows and is visible to a clinician. [009] In some embodiments, the gap may be close to the orifices. In some embodiments, the gap may be annular. In some embodiments, the introducer needle may include one or more grooves. In some embodiments, a distal end of each of the grooves may be close to a given orifice. In some embodiments, the gap may be disposed within the groove. In some embodiments, the orifices may be arranged so that some of the orifices are distal to other orifices. [010] In some embodiments, the introducer needle may include a distal end, a proximal end, and an introducer needle lumen that extends through the distal end of the introducer needle and the proximal end of the introducer needle, and an inner surface forming the introducer needle lumen. In some embodiments, the catheter system may include one or more sensors. In some embodiments, the sensors may be embedded in the inner surface of the introducer needle at the distal end of the introducer needle. Additionally, or alternatively, in some embodiments, the sensors may be embedded in the inner surface of the catheter at the distal end and nea