Vascular Access Device Having an Instrument Configured to Insert Into a Catheter

A vascular access device may include a housing, which may include a distal end, a proximal end, and a lumen extending through the distal end of the housing and the proximal end of the housing. The distal end of the housing may include a connector configured to couple to a catheter assembly. The vascular access device may include a bag, which may be coupled to the proximal end of the housing. The vascular access device may include an instrument and a pincher disposed within the bag. The pincher may be configured to pinch the instrument to move the instrument distally through the lumen of the housing and into the catheter assembly.

BACKGROUND OF THE INVENTION

Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used for infusing fluids, such as normal saline solution, various medicaments, and total parenteral nutrition, into a patient. Catheters may also be used for withdrawing blood from the patient.

A common type of catheter device includes a catheter that is over-the-needle. As its name implies, the catheter that is over-the-needle may be mounted over an introducer needle having a sharp distal tip. A catheter assembly may include a catheter adapter, the catheter extending distally from the catheter adapter, and the introducer needle extending through the catheter. The catheter and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing up away from skin of the patient. The catheter and introducer needle are generally inserted at a shallow angle through the skin into vasculature of the patient.

In order to verify proper placement of the introducer needle and/or the catheter in the blood vessel, a clinician generally confirms that there is “flashback” of blood in a flashback chamber of the catheter assembly. Once placement of the needle has been confirmed, the clinician may temporarily occlude flow in the vasculature and remove the needle, leaving the catheter in place for future blood withdrawal or fluid infusion.

Infusion and blood withdrawal using the catheter may be difficult for several reasons, particularly when an indwelling time of the catheter increase. A fibrin sheath or thrombus may form on an internal surface of the catheter assembly, an external surface of the catheter assembly, or within the vasculature near the distal tip of the catheter. The fibrin sheath or thrombus may block or narrow a fluid pathway through the catheter, which may impair infusion and/or collection of a high-quality blood sample.

SUMMARY OF THE INVENTION

The present disclosure relates generally to vascular access devices and related methods. In some embodiments, a vascular access device may include a housing, which may include a distal end, a proximal end, and a lumen extending through the distal end of the housing and the proximal end of the housing. In some embodiments, the distal end of the housing may include a connector configured to couple to a catheter assembly.

In some embodiments, the vascular access device may include a bag coupled to the proximal end of the housing. In some embodiments, the vascular access device may include an instrument disposed within the bag. In some embodiments, the instrument may include a distal end and a proximal end. In some embodiments, the vascular access device may include a pincher disposed within the bag and configured to pinch the instrument to move the instrument distally through the lumen of the housing.

In some embodiments, the vascular access device may include a septum, which may be disposed within the housing or a distal end of the bag. In some embodiments, the vascular access device may include a pull cord, which may be coupled to the proximal end of the instrument and may extend through an opening in the bag. In some embodiments, a proximal end of the pull cord may be coupled to a grip element.

In some embodiments, the housing may include a port between the distal end of the housing and the proximal end of the housing. In some embodiments, the vascular access device may include an extension tube and a blood collection device. In some embodiments, the extension tube may include a distal end integrated with the port and a proximal end coupled to the blood collection device.

In some embodiments, the blood collection device may include a sharp cannula. In some embodiments, the instrument may include a guidewire. In some embodiments, the pincher may include a U-shaped body having two arms configured to move towards each other to pinch the instrument. In some embodiments, an inner surface of the two arms may include a textured surface, such as a rough surface or an uneven surface, for example.

In some embodiments, the vascular access device may include a position indicator, which may be disposed on the instrument. In some embodiments, the instrument is in a retracted position. In some embodiments, in response to the instrument being in the retracted position, the distal end of the instrument may be disposed within the housing and the position indicator is disposed within the bag. In some embodiments, the pull cord may be compacted in response to the instrument being in the retracted position.

In some embodiments, the vascular access device may include a stop disposed on the instrument with an enlarged outer diameter. In some embodiments, in response to the instrument moving distally from the retracted position to an advanced position distal to the housing, the stop may contact an inner surface of the housing.

In some embodiments, a method may include coupling the vascular access device to the catheter assembly. In some embodiments, the method may include pinching the instrument with the pincher after coupling the vascular access device to the catheter assembly. In some embodiments, after pinching the instrument with the pincher, the method may include moving the instrument from the retracted position to the advanced position. In some embodiments, in response to the instrument being in the retracted position, the distal end of the instrument may be within the housing. In some embodiments, in response to the instrument being in the advanced position, the distal end of the instrument may be disposed within the catheter assembly or distal to the catheter assembly.

In some embodiments, the method may include collecting blood through the catheter assembly and the vascular access device after moving the instrument from the retracted position from the advanced position. In some embodiments, the method may include moving the instrument from the advanced position to the retracted position after collecting the blood through the catheter assembly and the vascular access device. In some embodiments, moving the instrument from the advanced position to the retracted position may include pulling the pull cord proximally.

In some embodiments, moving the instrument from the advanced position to the retracted position may include moving the distal end of the instrument from a position distal to the bag into the bag. In some embodiments, in response to the instrument being in the retracted position, the distal end of the instrument may be disposed within the housing and the position indicator is disposed within the bag.

In some embodiments, the vascular access device and movement of instrument to the advanced position may facilitate patency, fluid infusion, and blood draw by preventing or delaying thrombus development and attachment to a catheter or another portion of the catheter assembly.

It is to be understood that both the foregoing general description and the following detailed description are examples and explanatory and are not restrictive of the invention, as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentality illustrated in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense.

DETAILED DESCRIPTION OF THE INVENTION

Referring now toFIGS.1A-1C, in some embodiments, a vascular access device10may include a housing12, which may include a distal end14, a proximal end16, and a lumen extending through the distal end14of the housing12and the proximal end16of the housing12. In some embodiments, the distal end14of the housing12may include a connector18configured to couple to a catheter assembly.

In some embodiments, the connector18may include a male luer adapter or another suitable connector. In some embodiments, the connector18may include opposing lever arms20a,20b. In some embodiments, distal ends of the opposing lever arms20a,20bmay be configured to move apart from each other in response to pressure applied to proximal ends of the opposing lever arms20a,20b. In some embodiments, in response to removal of the pressure applied to the proximal ends of the opposing lever arms20a,20b, the distal ends may move closer to each other and clasp a portion of the catheter assembly, such as a needleless connector, a proximal end of a catheter adapter, or another portion of the catheter assembly.

In some embodiments, the vascular access device10may include a bag22, which may be coupled to the proximal end16of the housing12. In some embodiments, the bag22may include a distal end24and a proximal end26. In some embodiments, the distal end24of the bag22may be sealed around the proximal end16of the housing12. In some embodiments, the bag22may be approximately 6 inches long or another suitable length. In some embodiments, the housing12may be monolithically formed as a single unit. In other embodiments, the housing12may include multiple pieces coupled together.

In some embodiments, the vascular access device10may include an instrument28disposed within the bag22, which may protect the instrument28from bacteria. In some embodiments, the instrument28may be fully disposed within the bag22or partially disposed within the bag22. In some embodiments, a proximal end30of the instrument28may be disposed within the bag22when the instrument28is in an advanced position and/or a retracted position. In some embodiments, the vascular access device10may include a septum32(see, for example,FIG.3), which may be disposed within the housing12or the distal end24of the bag22. In some embodiments, a distal end of the instrument28may extend through the septum32and/or be disposed within the housing12when the instrument28is in the retracted position. In some embodiments, the septum32may provide guidance to the instrument28as the instrument28moves from the retracted position to the advanced position. In some embodiments, the septum32may provide some drag that may facilitate maintaining the instrument28in a desired position.

In some embodiments, the instrument28may include a guidewire, a probe, a guidewire or a probe with one or more sensors, or another suitable instrument. In some embodiments, the sensors may be used for patient or device monitoring and may include sensors measuring pressure, temperature, pH, blood chemistry, oxygen saturation, flow rate, or another physiological measure. In some embodiments, the instrument28may improve patency of the catheter of the catheter assembly for medication and fluid delivery, as well as blood acquisition, through a dwell time of the catheter.

In some embodiments, the instrument28may be constructed of metal or another suitable material. In some embodiments, the instrument28may be generally linear. In some embodiments, the instrument28may extend a life of the catheter for infusion and/or blood collection. For example, the instrument28may be configured to reduce or remove a thrombus from within the catheter assembly, within a catheter of the catheter assembly, or at a distal tip of the catheter of the catheter assembly. In some embodiments, the instrument28may open a valve within the vasculature and/or move obstructions away from the distal tip of the catheter.

In some embodiments, the vascular access device10may include a pincher36disposed within the bag22and configured to pinch the instrument28to move the instrument28distally through the lumen of the housing12. In some embodiments, the pincher36may include a U-shaped body having two arms37a,37bconfigured to move towards each other to pinch the instrument28. In some embodiments, an inner surface of the two arms37a,37bmay include a textured surface, which may enhance grip of the instrument28and prevent slipping. For example, the inner surface of the two arms37a,37bmay include an uneven surface with multiple bumps or protrusions or a rough surface.

In some embodiments, the vascular access device10may include a pull cord38, which may be coupled to the proximal end30of the instrument28and may extend through an opening39in the bag22. In some embodiments, the pull cord38may include string, rope, an elastomer, or another suitable material.

In some embodiments, a proximal end40of the pull cord38may be coupled to a grip element42. In some embodiments, the grip element42may include a tab, a ring, or another suitable grip element configured to facilitate gripping by a user. In some embodiments, a distal end44of the pull cord38may be tied or bonded to the proximal end30of the instrument28or coupled to the proximal end30of the instrument28via a connector46or another suitable method. In some embodiments, the proximal end30of the instrument28and/or the distal end44of the pull cord38may be integrated into the connector46.

In some embodiments, the housing12may include a port48between the distal end14of the housing12and the proximal end16of the housing12. In some embodiments, the vascular access device10may include an extension tube50and a blood collection device52. In some embodiments, the extension tube50may include a distal end54integrated with the port48and a proximal end56coupled to the blood collection device52. In some embodiments, the extension tube50may be in fluid communication with the lumen of the housing12.

In some embodiments, the blood collection device52may include a sharp cannula58and/or a holder59configured to receive a container such as a test tube or BD VACUTAINER® Blood Collection Tube, available from Becton Dickinson & Company of Franklin Lakes, N.J. In some embodiments, the blood collection device52may include a luer lock access device or another suitable device.

In some embodiments, the instrument28may be in a retracted position, as illustrated, for example inFIGS.1A-1B. In some embodiments, the instrument28may initially be placed in the retracted position during manufacture and/or the instrument28may be moved to the retracted position after being in the advanced position, illustrated, for example, inFIG.1C. In some embodiments, the vascular access device10may include a position indicator60, which may be disposed on the instrument28. In some embodiments, the position indicator60may include a marking on the instrument28, such as, for example, one or more lines or one or more annular lines. In some embodiments, the position indicator60may include a different color than portions of the instrument28proximate or adjacent the position indicator60, which may facilitate visualization of the position indicator60. In some embodiments, the bag22may be transparent, which may facilitate visualization of the position indicator60by the user.

In some embodiments, in response to the instrument28being in the retracted position, the distal end24of the instrument28may be disposed within the housing12and/or the position indicator60may be disposed within the bag22. Thus, in some embodiments, the position indicator60may indicate to the user that the instrument28is in the retracted position. In some embodiments, in response to the instrument28being in the retracted position, the position indicator60may be approximately aligned with the proximal end16of the housing12. In some embodiments, the bag22and/or the housing12may include another position indicator, and in response to the position indicator60being aligned with the other position indicator, the instrument28may be in the retracted position or another position. In some embodiments, the other position indicator may be similar or identical to the position indicator60in terms of one or more features. In some embodiments, the pull cord38may be compacted within the bag22in response to the instrument28being in the retracted position. For example, the pull cord38may be wound or folded back on itself within the bag22.

Referring now toFIGS.2-3, in some embodiments, an outer diameter of the pull cord38may be approximately equal to or slightly less than an inner diameter of the opening39such that the opening39forms a seal around the pull cord38or air flowing through the opening39is limited, which may decrease a risk of bacterial contamination or the vascular access device10and the instrument28. In some embodiments, the opening39may prevent the bag22from pinching and forcing air into the patient. In some embodiments, the bag22may include the opening39, another suitable opening, a vent, a membrane, or another suitable feature through which air and/or the pull cord39may pass.

In some embodiments, the vascular access device10may include a stop62disposed on the instrument28with an enlarged outer diameter. In some embodiments, in response to the instrument28moving distally from the retracted position to the advanced position, the stop62may contact an inner surface64of the housing12and/or the septum32, and the instrument28may be prevented from advancing further in a distal direction. In some embodiments, the inner surface64may be disposed within the lumen65of the housing12. In some embodiments, the stop62may correspond to the connector46.

In some embodiments, the vascular access device10may be coupled to the catheter assembly66. In some embodiments, the catheter assembly66may include the catheter adapter68, which may include a distal end70, a proximal end72, and a lumen74extending through the distal end70and the proximal end72. In some embodiments, the catheter assembly66may include the catheter76, which may extend distally from the catheter adapter68. In some embodiments, the catheter76may include a peripheral intravenous catheter, a midline catheter, or a peripherally inserted central catheter. In some embodiments, a needle assembly (not illustrated) may be coupled to the proximal end72of the catheter adapter68and may include an introducer needle extending through the catheter76. In some embodiments, the needle assembly may be removed from the catheter assembly66in response to the catheter76being positioned within vasculature of a patient and/or observation of flashback of blood.

In some embodiments, the catheter adapter68may include a side port79disposed between the distal end70and the proximal end72of the catheter adapter68. In some embodiments, a distal end of an extension tube78may be integrated with the side port79and/or a proximal end of the extension tube78may be integrated with a connector80. In some embodiments, the connector80may be coupled with a needleless connector82, which may be coupled to the vascular access device10. In some embodiments, the catheter assembly66and its components may vary. In some embodiments, the vascular access device10may be connected to another portion of the catheter assembly66.

In some embodiments, in response to insertion of the catheter76into the vasculature of the patient, blood may flow in a fluid pathway that may extend through one or more of the catheter76, the catheter adapter68, the side port79, the connector80, and the needleless connector82. In some embodiments, the fluid pathway may extend into the housing12, through the port48, and to the blood collection device52. In some embodiments, the blood may be prevented from flowing proximally through the housing12and into the bag22due to presence of the septum32, which may provide a fluid seal. In some embodiments, the septum32may include any suitable septum configured to provide the fluid seal.

In some embodiments, a length L of a portion of the fluid pathway within the vascular access device10may be selected based on one or more of the following: a gauge of the catheter76, a particular configuration of the catheter assembly66, or a clinical setup. In some embodiments, the portion of the fluid pathway within the vascular access device10may extend from the distal end14of the housing12through the port48and through the extension tube50. In some embodiments, the portion of the fluid pathway may extend through a connector disposed at a proximal end of the extension tube50and/or into the blood collection device52, such as, the sharp cannula58. In some embodiments, the portion of the fluid pathway may include an inner diameter D.

Fluid flow in the portion of the fluid pathway can be analyzed using Poiseuille's equation, when the portion of the fluid pathway is tubular:

where ΔP is a change in pressure gradient across the length of the portion of the fluid pathway, D and L are the inner diameter and length, respectively, of the portion of the fluid pathway, μ is the viscosity of a fluid, and

is the fluid resistance. Since μ is the viscosity of the fluid and not part of the extension tube geometry, a geometric factor Gfis defined such that Rf(the fluid resistance) is

In some embodiments, the portion of the fluid pathway may have multiple sections with lengths (L1, L2, L3) and inner diameters of (D1, D2, D3), the geometric factor is then:

In some embodiments, the portion of the fluid pathway may have an inner diameter that changes over the length of the portion of the fluid pathway, the geometric factor is then:

In some embodiments, the portion of the fluid pathway may have a cross section that is not circular or may have a complicated inner diameter profile. The geometric factor can then be determined by measuring the flow rate (Q) at given pressure (ΔP) with known viscosity (μ) fluid:

The Gfvalue of the portion of the fluid pathway may be selected to reduce the maximum shear stress for each catheter gauge to be the same or less than the max shear stress of a BD 21G VACUTAINER® UltraTouch™ push button blood collection set (available from Becton, Dickinson & Company of Franklin Lakes, N.J.), which was previously considered the gold standard for blood draws. In some embodiments, Gfvalue of the portion of the fluid pathway may be selected to reduce the maximum shear stress for each catheter gauge to be the same or less than the max shear stress of a BD 25G VACUTAINER® UltraTouch™ push button blood collection set (available from Becton, Dickinson & Company of Franklin Lakes, N.J.).

In some embodiments, the fluid pathway of a catheter system, such as, for example, that ofFIGS.2-3, which include the portion of the fluid pathway, may include an entirety of a blood collection pathway through which blood flows after leaving the vasculature and into or through the blood collection device52during blood collection. The system geometric factor Gfsfor the fluid pathway of the catheter system can be determined in similar fashion as the Gfvalue of the portion of the fluid pathway described earlier. In some embodiments, the system geometric factor Gfswith the instrument28at the advanced position may be equal to or more than 7.34E+06 (1/in3). In some embodiments, Gfs may include another value. In some embodiments, the system geometric factor Gfswith the instrument28at the advanced position may be 7.34E+06 (1/in3) plus or minus 10 percent, plus or minus 25 percent, plus or minus 50 percent, or plus or minus 75 percent. In some embodiments, Gfsmay include another value, which may be selected based on a gauge and/or length of the catheter.

In some embodiments, the bag22may be constructed of a flexible and compressible material. In some embodiments, the bag22may include polyethylene or another suitable material. As illustrated inFIG.3, the bag22may bunch or collapse in response to advancement of the instrument28by pinching the instrument28with the pincher36through the bag22. In some embodiments, only the portion of the bag22may bunch up, such that the bag22does not interfere with advancement of the instrument28.

In some embodiments, when the instrument28is in the retracted position, the distal end34of the instrument28may be disposed within the housing12to prevent contact of the instrument28with an external environment outside of the vascular access device10. In some embodiments, when the instrument28is in the retracted position, the instrument28may extend through the septum32, which may provide stability and/or guidance of the instrument28. In some embodiments, when the instrument28is in the advanced position, as illustrated, for example, inFIG.3, the distal end34of the instrument28may be disposed within the catheter assembly66or distal to the catheter76, which may facilitate thrombus removal.

Referring now toFIGS.4A-4D, in some embodiments, a method may include coupling the vascular access device10to the catheter assembly66, as illustrated, for example, inFIG.4A. In some embodiments, the vascular access device10may be coupled to the catheter assembly66after the catheter assembly66is inserted into the vasculature of the patient.

In some embodiments, the method may include pinching the instrument28with the pincher36after coupling the vascular access device10to the catheter assembly66, as illustrated, for example, inFIG.4B. In some embodiments, after pinching the instrument28with the pincher36, the method may include moving the instrument28distally from the retracted position to the advanced position. In some embodiments, the vascular access device10and movement of the instrument28to the advanced position may facilitate patency, fluid infusion, and blood draw by preventing or delaying thrombus development and attachment to the catheter assembly66.

In some embodiments, the method may include collecting blood through the catheter assembly66and the vascular access device10after moving the instrument28from the retracted position from the advanced position, as illustrated, for example, inFIG.4C. In some embodiments, collecting blood may include inserting the BD VACUTAINER® Blood Collection Tube (available from Becton Dickinson & Company of Franklin Lakes, N.J.) into the blood collection device such that the sharp cannula58pierces through a stopper of the BD VACUTAINER® Blood Collection Tube. In some embodiments, blood collection may be accomplished with a syringe or another suitable blood collection device, which may be coupled to the extension tube50and/or the port48.

In some embodiments, the method may include moving the instrument28from the advanced position to the retracted position after collecting the blood through the catheter assembly66and the vascular access device10. In some embodiments, moving the instrument28from the advanced position to the retracted position may include pulling the pull cord38proximally, as illustrated inFIG.4D, for example. In some embodiments, the pincher36may be used to move the instrument28from the advanced position to the retracted position by pinching the instrument28.

In some embodiments, moving the instrument from the advanced position to the retracted position may include moving the distal end34of the instrument28from a position distal to the bag22into the bag22. In some embodiments, the instrument28may not be connected to the bag22and may be movable with respect to the bag22. In some embodiments, in response to the instrument28being in the retracted position, the distal end34of the instrument28may be disposed within the housing12, which may prevent the instrument28from poking a hole in the bag22, and/or the position indicator60may be disposed within the bag22such that the position indicator60is visible to the user. In some embodiments, the instrument28may be fully retracted when the instrument28is in the retracted position.

In some embodiments, after the instrument28is moved to the retracted position, the vascular access device10may be uncoupled from the catheter assembly66. In some embodiments, the vascular access device10may then be disposed of, and the bag22may reduce an amount of disposal material significantly. In some embodiments, the vascular access device10may include only two molded components, the pincher36and the housing12, which may reduce a cost of manufacture of the vascular access device10.

Referring now toFIGS.5A-5D, in some embodiments, the pincher36may include the U-shaped body having the two arms37a,37bconfigured to move towards each other to pinch the instrument28. In some embodiments, the two arms37a,37bmay be biased away from each other and brought into contact in response to pinching of the two arms37a,37bby the user. In some embodiments, the two arms37a,37bmay move apart from each other when the user reduces or ceases pinching, thus allowing the user to move the pincher36to a more proximal portion of the instrument28for further pinching and distal advancement of the instrument28.

In some embodiments, the two arms37a,37bmay move apart from each other when the user reduces or ceases pinching due to the pincher36being constructed of a resilient material. In some embodiments, the pincher36may include a spring or other biasing mechanism, which may bias the two arms37a,37baway from each other. In some embodiments, the pincher36may include an alligator clip or another suitable pinching device.

In some embodiments, to advance the instrument28distally, the user may grip the instrument28using the pincher36. In some embodiments, while bunching up a portion of the bag22, the user may then advance the instrument28distally through the housing12and/or into and/or through the catheter. In some embodiments, the user may then release the pincher36, which allows the pincher36to open, and the bag22may be retracted proximally along a shaft of the instrument28. In some embodiments, the user may then grip the instrument28again using the pincher36and advance the instrument28further in the distal direction, such as, for example, into and/or through the catheter.