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BR-112021013470-B1 - Needle-free access connector to facilitate instrument delivery to a catheter assembly.

BR112021013470B1BR 112021013470 B1BR112021013470 B1BR 112021013470B1BR-112021013470-B1

Abstract

Needle-free access connector to facilitate instrument delivery to a catheter assembly. A needle-free access connector may include a body, which may include a proximal end configured to attach to an instrument delivery device and a distal end configured to attach to a peripheral intravenous catheter assembly. The needle-free access connector may also include a bellows valve disposed within the body between the proximal and distal ends. The bellows valve may include a bellows portion. In response to compression of the bellows portion and opening of the bellows valve, a straight path extending through the proximal and distal ends may be exposed, so that an instrument from the instrument delivery device can move distally from the proximal end to the distal end through the straight path without bending.

Inventors

  • JONATHAN KARL BURKHOLZ
  • Heena Dani
  • Megan Scherich
  • Derek Jewell

Assignees

  • BECTON, DICKINSON AND COMPANY

Dates

Publication Date
20260310
Application Date
20200110
Priority Date
20200109

Claims (14)

  1. 1. Needle-free access connector (10), comprising: a body (55), comprising: a proximal end (38) configured to couple to an instrument delivery device (22); and a distal end (12) configured to couple to a peripheral intravenous catheter assembly; a bellows valve (16) disposed within the body between the proximal end and the distal end, wherein the bellows valve comprises a bellows portion (32) and a rigid portion (34) disposed proximal to the bellows portion, wherein, in response to compression of the bellows portion and opening of the bellows valve, a straight path (24) extending through the proximal end and the distal end is exposed, so that an instrument (26) of the instrument delivery device can move distally from the proximal end to the distal end through the straight path without bending; a post (14), CHARACTERIZED in that the post is configured to extend through the bellows valve when the bellows valve is open, and a proximal end (30) of the post is flexible.
  2. 2. Needle-less access connector according to claim 1, characterized in that the rigid portion contacts the post.
  3. 3. Needle-free access connector according to claim 1, CHARACTERIZED in that the proximal end of the bellows valve comprises a rigid portion.
  4. 4. Needle-free access connector, according to claim 1, CHARACTERIZED in that it comprises a male luer fitting (18) configured to slide between a proximal position and a distal position, wherein, in response to the sliding of the male luer fitting from the proximal position to the distal position, the male luer fittings come into contact with a proximal end of the bellows valve and move the bellows valve distally.
  5. 5. Needleless access connector according to claim 4, CHARACTERIZED in that the bellows valve comprises a slot (28), and the slot opens in response to contact of the male luer fitting and before the bellows valve comes into contact with the post.
  6. 6. Needle-free access connector, according to claim 1, CHARACTERIZED in that it further comprises an anti-reflux valve (42, 42a) disposed within the body between the proximal end and the distal end.
  7. 7. Needle-free access connector, according to claim 6, CHARACTERIZED in that it further comprises another anti-reflux valve (42b) disposed within the body between the proximal end and the distal end.
  8. 8. Needle-free access connector, according to claim 6, CHARACTERIZED in that the body comprises a first piece comprising the anti-reflux valve and a second piece comprising the bellows valve, wherein a luer fitting of the first piece is coupled to a corresponding luer fitting of the second piece.
  9. 9. Needle-free access connector according to claim 8, CHARACTERIZED in that the second part comprises a side port (54) and an extension tube (67) extending from the side port.
  10. 10. Needle-free access connector, according to claim 1, CHARACTERIZED in that the distal end is coupled to the peripheral intravenous catheter assembly.
  11. 11. Needleless access connector, according to claim 1, CHARACTERIZED in that it further comprises a side port (54), wherein the side port comprises another valve (58), wherein the other valve is compressible, such that fluid flows around an outer surface of the other valve to pass through the other valve.
  12. 12. Needle-free access connector, according to claim 1, CHARACTERIZED in that the distal end comprises an extension tube (67), wherein the extension tube extends outward from a distal port (66).
  13. 13. Needle-free access connector, according to claim 1, CHARACTERIZED in that it comprises a lumen extending between the proximal end and the distal end, wherein the lumen is closed between the distal opening of the distal end of the body and the proximal opening of the proximal end of the body.
  14. 14. Needle-free access connector according to claim 7, CHARACTERIZED in that the anti-reflux valve is adjacent to another anti-reflux valve.

Description

BACKGROUND [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 vasculature. [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 a backflow chamber of a PIVC set. Once needle placement has been confirmed, the clinician may temporarily occlude flow in the vasculature and remove the introducer needle, leaving the PIVC in place for future blood withdrawal and/or fluid infusion. [004] Withdrawing blood using a peripheral IV catheter can be difficult for several reasons, particularly when the catheter dwell time exceeds one day. For example, when the catheter is left inserted in the patient for an extended period, the catheter may become more susceptible to narrowing, collapse, twisting, blockage by debris (e.g., fibrin or platelet clots), and adhesion of a catheter tip to the vasculature. Because of this, catheters can often be used to obtain a blood sample at the time of catheter placement, but are used much less frequently to obtain a blood sample during the catheter dwell time. Therefore, when a blood sample is needed, an additional needle stick is required to provide vein access for blood collection, which can be painful for the patient and result in higher material costs. Consequently, there is a need for catheter systems and methods that facilitate the placement of blood sampling instruments, such as catheters and probe instruments, into the patient's vasculature without additional needle sticks. [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 of a technology area where some implementations described herein may be practiced. SUMMARY [006] The present disclosure generally relates to needle-free access connectors ("NACs") and related systems and methods. In some embodiments, an NAC may include a body, which may include a proximal end configured to couple to an instrument delivery device and a distal end configured to couple to a peripheral intravenous catheter assembly. In some embodiments, the NAC may also include a bellows valve disposed within the body between the proximal and distal ends. [007] In some embodiments, the bellows valve may include a bellows portion. In some embodiments, in response to compression of the bellows portion and opening of the bellows valve, a straight path extending through the proximal end and the distal end may be exposed, so that an instrument from the instrument delivery device may move distally from the proximal end to the distal end through the straight path without bending. [008] In some embodiments, the NAC may include a pin/post configured to extend through the bellows valve when the bellows valve is open. In some embodiments, a proximal end of the post may be flexible. In some embodiments, the bellows valve may include a rigid portion, which may be disposed near the bellows portion. In some embodiments, the rigid portion may be disposed on an inner surface of the bellows valve. In some embodiments, the rigid portion may contact the post. In some embodiments, a proximal end of the bellows valve may include the rigid portion. [009] In some embodiments, the NAC may include a male luer fitting configured to slide between a proximal and a distal position. In some embodiments, in response to the male luer fitting sliding from the proximal to the distal position, the male luer fitting may contact a proximal end of the bellows valve and move the bellows valve distally. In some embodiments, the bellows valve may include a slot. In some embodiments, the slot may open in response to contact with the male luer fitting and before the bellows valve contacts the post. In some embodiments, in response to the male luer fitting sliding from the proximal to the distal position, the bellows valve may open at the post. [010] In some embodiments, the NAC may include an antireflux valve, which may be disposed within the body between the proximal and distal ends. In some embodiments, the NAC may include another antireflux valve disposed within the body between the