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EP-4370189-B1 - SAFETY CATHETER ASSEMBLY WITH PASSIVE BLOOD CONTROL

EP4370189B1EP 4370189 B1EP4370189 B1EP 4370189B1EP-4370189-B1

Inventors

  • ROEHL, CHRISTOPHER, D.
  • KOEHLER, THOMAS, T.

Dates

Publication Date
20260506
Application Date
20220725

Claims (15)

  1. A safety catheter device comprising: a catheter hub (300) having a body including an internal cavity (302) extending between a distal end (306) and an opened proximal end (310); a seal member (400) having a substantially cylindrical wall (410) defining a bore (411) non-removably positioned in the internal cavity (302) of the catheter hub, a membrane (418) integral of the seal member partitioning the seal member into a hollow distal portion (404) and a hollow proximal portion (402) opened to the proximal end (310) of the catheter hub (300); a catheter (4) having a distal end (4a) extending from the distal end (306) of the catheter hub (300) to establish a through passageway between the distal end of the catheter and the internal cavity (302) distal of the membrane (418); a needle (6) having a proximal end attached to a needle hub (602) and a sharp distal tip (6a) adapted to extend through the catheter (4) until the distal tip of the needle extends beyond the distal end (4a) of the catheter; a needle tip protector (1100, 1200) slidably positioned along the needle (6) having at least one barrier (1108. 1110) and opposing bosses (1112, 1114) being biased away from each other so as to be in fixed engagement with the wall (410) at the hollow proximal portion (402) of the seal member (400) when the distal tip (6a) of the needle is distal of the barrier (1108, 1110); a guard (700) in coupled relationship with a proximal portion of the catheter hub (300) that includes the catheter hub proximal end (310) when the needle tip protector (1100, 1200) is in fixed engagement with the seal member (400), the guard having at least one extension (704a, 704b) that overlaps the proximal portion of the catheter hub (300) when the safety catheter device is in a ready to use position.
  2. The safety catheter device of claim 1, wherein the guard (700) includes a chamber (712) configured to house the needle tip protector (1100, 1200), wherein when the distal tip (6a) of the needle (6) is positioned proximal the barrier (1108, 1110) such that the opposing bosses (1112, 1114) are no longer biased against the wall (410) of the seal member (400), further movement of the needle (6) in the proximal direction relative to the catheter hub (300) causes the needle tip protector (1100, 1200) to be housed in the chamber (712) and the guard (700) to decouple from the proximal portion of the catheter hub (300).
  3. The safety catheter device of claim 2, wherein the guard (700) includes a shoulder (723) connecting the chamber (712) and the extension (704a, 704b) of the guard configured to abut the opened proximal end (310) of the catheter hub (300) when the safety catheter device is in the ready to use position.
  4. The safety catheter device of claim 2, wherein the needle hub (602) is in a needle housing (600) having an opened distal receptacle (618) for receiving at least a proximal portion of the chamber (712) of the guard (700) when the safety catheter device is in the ready to use position.
  5. The safety catheter device of any of the preceding claims, further comprising: an actuator (500) positioned in the internal cavity (302) of the catheter hub (300) having a proximal end (508) extending proximally from the distal end (306) of the catheter hub (300), the proximal end (508) of the actuator positioned distal from the membrane (418) when the safety catheter device is in a ready to use position.
  6. The safety catheter device of any of the preceding claims, wherein the distal portion (404) of the seal member (400) has an accordion shape and is compressible when the proximal end (416) of the seal member (400) is impacted by a distal force, the distal portion (404) of the seal member returning to its original shape when the distal force is removed.
  7. The safety catheter device of claim 6, wherein the membrane (418) meets and is opened by the proximal end (508) of the actuator (500) when the distal force pushes the seal member (400) in the distal direction to move the membrane (418) into the proximal end of the actuator.
  8. The safety catheter device of any of the preceding claims, further comprising: a cup (900) for enclosing at least a portion of the needle tip protector (1100, 1200) having a proximal base (910) including an orifice (914) to enable the needle (6) to pass therethrough, the cup having a distal opening (904) for accepting the needle tip protector (1100, 1200) into the cup, the proximal base (910) of the cup fixedly attached to the base (1102) of the needle tip protector (1100) so that the cup (900) and the needle tip protector (1100) are movable in unison, the proximal base (910) of the cup (900) movably positioned into abutment with a proximal end of a chamber (712) of the guard (700) when the safety catheter device is in a safe position.
  9. The safety catheter device of claim 8, wherein the cup (900) comprises a cylinder defined by a circumferential wall extending distally from its base (910), the distal end (906) of the wall held between a proximal end portion (416) of the seal member (400) and the interior cavity (302) of the catheter hub (300) when the safety catheter device is in the ready to use position.
  10. The safety catheter device of claim 8, wherein the chamber (712) of the guard (700) has at least one stop (716) that biases against the distal end (906) of the tip protector cup (900) to prevent distal movement of the needle tip protector (1100) and cup (900) when the cup is fully retracted into the chamber.
  11. The safety catheter device of claim 1 or claim 8, wherein the needle tip protector (1100) comprises a base (1102) having an opening (1116) for the needle (6) to pass through and two elongate arms (1104, 1106) each having one of the opposing bosses (1112, 1114) extending distally from the base, the arms biased by the needle such that the opposing bosses (1104, 1106) are pressed into the fixed engagement with the seal member (400) when the safety catheter device is in the ready to use position; wherein when the distal tip (6a) of the needle (6) is moved proximal the barrier (1108, 1110) of the tip protector, the arms (1104, 1106) being no longer biased by the needle would return to their natural position such that the opposing bosses (1104, 1106) are no longer fixedly engaged to the seal member.
  12. The safety catheter device of claim 4, wherein the needle housing (600) comprises an elongated housing including a flash blood compartment (614) to receive fluid from the proximal end of the needle (6) attached to the needle hub (602), the flash blood compartment having a proximal end (610) closed by a flash plug (800).
  13. A method of making a safety catheter device comprising the steps of: providing a catheter hub (300) having a body including an internal cavity (302) extending between a distal end (306) and an opened proximal end (310); non-removably positioning a seal member (400) having a substantially cylindrical wall (410) defining a bore (411) in the internal cavity (302) of the catheter hub (300), a membrane (418) integral of the seal member partitioning the seal member into a hollow distal portion (404) and a hollow proximal portion (402) opened to the proximal end (310) of the catheter hub (300); connecting a catheter (4) having a distal end (4a) to the distal end (306) of the catheter hub (300) to establish a through passageway between the distal end of the catheter and the internal cavity (302) distal of the membrane (418); attaching a proximal end of a needle (6) to a needle hub (602), the needle having a sharp distal tip (6a) adapted to extend through the catheter (4) until the distal tip (6a) of the needle extends beyond the distal end (4a) of the catheter; slidably positioning a needle tip protector (1100, 1200) along the needle (6), the needle tip protector having at least one barrier (1108, 1110) and opposing bosses (1112, 1114); positioning the distal tip (6a) of the needle distally of the barrier (1108, 1110) to bias the opposing bosses (1112, 1114) to be in fixed engagement with the wall (410) at the hollow proximal portion (402) of the seal member (400); and coupling a guard (700) having at least one extension (704a, 704b) to a proximal portion of the catheter hub (300) when the needle tip protector (1100, 1200) is in fixed engagement with the seal member (400) so that the extension overlaps the proximal portion when the safety catheter device is in a ready to use position.
  14. The method of claim 13, further comprising the step of: providing a chamber (712) in the guard (700) configured to house the needle tip protector (1100, 1200) when the distal tip (6a) of the needle (6) is positioned proximal the barrier (1108, 1110) such that the opposing bosses (1112, 1114) are not biased against the wall (410) of the seal member (400) and further movement of the needle (6) in the proximal direction relative to the catheter hub (300) causes the needle tip protector (1100, 1200) to be housed in the chamber (712) and the guard (700) to decouple from the proximal portion of the catheter hub (300).
  15. The method of claim 13 or claim 14, further comprising the steps of: providing a cup (900) having a proximal base (910) including an orifice (914) to enable the needle (6) to pass therethrough for enclosing at least a portion of the needle tip protector (1100), the cup (900) having a distal opening (904) and a circumferential wall extending distally from the base (910) adapted to accept the needle tip protector (1100, 1200) into the cup; fixedly attaching the proximal base (910) of the cup (900) to the base (1102) of the needle tip protector (1100) so that the cup (900) and the needle tip protector (1100) are movable in unison; fittingly holding the distal end (906) of the wall between a proximal end portion (416) of the seal member (400) and the interior cavity (302) of the catheter hub (300) when the safety catheter device is in the ready to use position.

Description

Field of the Invention The present invention relates to safety catheter assemblies and catheter devices including for example peripheral intravenous catheters (PIVC's) and, more particularly, to a safety catheter assembly having a guarded passive release mechanism that shields the sharp distal tip of the needle of the device from at least when the device is ready to be used to the disposal of the device after use. Background of the Invention Conventional PIVC's devices include a catheter assembly, typically having a catheter hub and a catheter tube extending distally thereof, and a needle assembly mounted together in an over-the-needle fashion. The needle assembly typically includes a needle hub or support and a needle cannula extending distally from the needle hub. In a ready to use position, a PIVC has the needle cannula extending through the catheter tube to expose its sharp distal tip distally beyond the distal end of the catheter tube. The sharp distal tip of the needle cannula is used to penetrate the tissue of the patient for insertion of the catheter tube within the vasculature system of a patient. Once the catheter tube is disposed within the vasculature, the needle cannula is withdrawn from the catheter assembly while the catheter assembly remains in fluid communication with the vasculature. The PIVC may also include a needle protector to enclose at least the sharp distal tip of the needle cannula, if not the entire cannula, after use. A PIVC with a protector may be referred to as a safety catheter device or simply a safety catheter. The catheter hub typically has an open proximal end adapted to receive a male luer taper into the interior cavity of the catheter hub to establish a fluid connection between the patient's vasculature and the luer taper. The proximal end may also be provided with external ears, flange or the like to secure the luer taper in the catheter hub, for example when the luer taper is coupled with a male luer lock collar or nut to form part of a male luer lock connector of an administration set or the end of a syringe, or the like. Under normal conditions, after withdrawal of the needle cannula and before a luer taper is inserted into the catheter hub, blood immediately starts flowing through the catheter tube and into the interior cavity of the catheter hub. As described in US10,080,867, assigned to the same assignee as the present application, a seal member is disposed in and non-removably held to the interior cavity of the catheter hub. The seal member includes a membrane and at least a distal portion extending distally from the membrane to form a sealed cavity between the membrane and the distal end of the catheter hub. An actuator having a substantially tubular configuration has its distal end secured to the distal end of the catheter hub where the proximal end of the catheter is also secured. The proximal opened end of the actuator is positioned distal of the membrane, so that were the proximal end of the seal member impacted or driven by a force in the distal direction, the membrane would be biased against the proximal opened end of the actuator to an opened position to effect a through passage between the distal end of the catheter and the interior cavity of the catheter hub. Once the distal directional force is removed from the proximal end of the seal member, the distal portion of the seal member would return to its natural position so as to move the membrane away from the opened proximal end of the actuator. No longer biased by the actuator, the membrane reseals to form a partition to prevent back flow of fluid into the interior cavity of the catheter hub proximally beyond the membrane. In some cases, the safety catheter device may include a needle tip protector through which at least a portion of the needle cannula, or simply needle, passes. The tip protector is configured to enclose or shield the sharp distal tip of the needle after its withdrawal from the catheter tube. The proximal end of the needle is attached to a needle hub, which may be a standalone hub or one that is integrated to a needle housing. The combination of the needle, the needle tip protector and the needle hub may be referred to as the needle assembly or needle insertion assembly or device. Conventionally, once the sharp distal tip of the needle is enclosed in the needle tip protector, the needle tip protector is withdrawn from the catheter hub. Thus, if the needle hub is a standalone hub, the needle tip protector and the portion of the needle between the needle hub and the tip protector is exposed. Even when there is a needle housing, the tip protector is exposed between the time it is withdrawn from the catheter hub and when it is pulled into the distal end of the needle housing. Fluid such as for example contaminated blood that may have adhered to the distal portion of the needle conceivably may be exposed to the environment. Other prior art arrangements are disclosed in US 2021/100985 and US