Catheter system and related methods for facilitating blood collection

Abstract

A catheter system may include a catheter assembly, which may include a catheter adapter and a catheter extending distally from a distal end of the catheter adapter. The catheter system may also include a needle assembly, which may include a needle hub and an introducer needle. The needle hub may include: a distal end coupled to the proximal end of the catheter adapter; a proximal end; a wall disposed between the distal end of the needle hub and the proximal end of the needle hub; and a blood flashback chamber adjacent to the wall. The introducer needle may be press-fit into a through-hole in the wall. The catheter system may also include a plug coupled to the proximal end of the needle hub. A blood collection device may be coupled to the proximal end of the plug to collect blood from a patient.

Description

Background Art

[0001] Intravenous catheters are commonly used for a variety of infusion therapies. For example, intravenous catheters can be used to infuse fluids such as saline solutions, various medications, and total parenteral nutrition into a patient's body. Intravenous catheters can also be used to draw blood from a patient's body.

[0002] Common types of intravenous catheters are peripherally inserted central catheters ("PIVCs"), peripherally inserted central catheters ("PICCs"), and midline catheters. Intravenous catheters can include "over-the-needle" catheters, which can be mounted on a needle having a sharp distal tip. The sharp distal tip can be used to penetrate the patient's skin and vasculature. Insertion of the intravenous catheter into the vasculature can follow penetration of the needle into the vasculature. The needle and intravenous catheter are typically inserted through the skin into the patient's vasculature at a shallow angle, with the bevel of the needle facing upward and away from the patient's skin.

[0003] To verify proper placement of the introducer needle and / or intravenous catheter within the vasculature, the user typically confirms the presence of blood flashback, which is visible to the user. In some cases, the introducer needle may include a notch disposed toward the distal end of the introducer needle, and in response to the distal tip of the introducer needle being positioned within the vasculature, blood may flow proximally through the needle lumen, exit the needle lumen through the notch, and subsequently travel proximally between the outer surface of the introducer needle and the inner surface of the intravenous catheter.

[0004] Thus, with the intravenous catheter at least partially transparent, the user can see a small amount of blood "flashback" and thereby confirm the placement of the intravenous catheter within the vascular system. The presence of a vascular system entry indicator (such as blood flashback) may aid in the successful placement of the intravenous catheter. Once the placement of the introducer needle within the vascular system has been confirmed, the user can temporarily block flow in the vascular system and withdraw the introducer needle, leaving the intravenous catheter in place for future blood draws and / or infusions.

[0005] The claimed subject matter herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is merely provided to illustrate one example technology area where some embodiments described herein may be practiced. Summary of the Invention

[0006] The present disclosure generally relates to devices, systems, and methods for facilitating blood sampling. In some embodiments, a catheter system may include a catheter assembly, which may include a catheter adapter and a catheter. In some embodiments, the catheter adapter may include a distal portion, a proximal portion, and a lumen extending through the distal portion and the proximal portion of the catheter adapter. In some embodiments, the catheter may be secured within the catheter adapter and may extend distally from the distal portion of the catheter adapter.

[0007] In some embodiments, the catheter system can include a needle assembly, the needle assembly can include a needle hub, and the needle hub can include a distal portion coupled to the proximal portion of the catheter adapter. In some embodiments, the needle hub can include a proximal portion and a blood flashback chamber extending through the proximal portion of the needle hub. In some embodiments, the needle hub can include a through hole disposed at the distal portion of the blood flashback chamber. In some embodiments, the introducer needle can be press-fitted into the through hole.

[0008] In some embodiments, the catheter system may include a stopper coupled to the proximal end of the needle hub. In some embodiments, the stopper may block the proximal opening of the blood flashback chamber and provide venting of the blood flashback chamber. In some embodiments, the stopper may include a distal end, a proximal end, an inner cavity extending through the distal end and the proximal end of the stopper, and a tubular section disposed between the distal end and the proximal end of the stopper. In some embodiments, the distal end of the stopper may include a neck portion and a skirt portion, each of which may extend from the tubular section to define an annular channel between the skirt portion and the neck portion.

[0009] In some embodiments, the neck portion can be inserted into the proximal portion of the needle hub. In some embodiments, the outer surface of the neck portion can include one or more vent channels that can be configured to provide venting of the blood flashback chamber. In some embodiments, the proximal portion of the stopper can include a Luer adapter. In some embodiments, the proximal portion of the stopper can include a septum that can be positioned within the Luer adapter.

[0010] In some embodiments, the diaphragm may include an elastically deformable piston element. In some embodiments, the piston element may include a piston head coupled to one or more bellows. In some embodiments, the piston head may include a slit or hole.

[0011] In some embodiments, the septum can include a proximal portion that can be positioned on the exterior of the Luer adapter. In some embodiments, the septum can include a distal portion that can extend across the tubular segment. In some embodiments, the septum can include a middle portion that can be positioned between the proximal portion and the distal portion. In some embodiments, the septum can include a slit that can extend longitudinally through the proximal portion, the distal portion, and the middle portion. In some embodiments, the cross-sections of the proximal portion, the distal portion, and the middle portion can form a generally H-shape.

[0012] In some embodiments, a portion of the wall of the tubular section can include an aperture extending through the wall. In some embodiments, a hydrophobic membrane can be positioned within the aperture toward the exterior of the stopper. In some embodiments, a hydrophilic membrane can be positioned within the aperture toward the interior of the stopper and / or adjacent to the hydrophobic membrane. In some embodiments, the hydrophilic membrane can prevent fluid from leaking through the aperture, and the hydrophobic membrane can provide venting of the blood flashback chamber. In some embodiments, the aperture can be distal to the distal portion of the septum.

[0013] In some embodiments, as an alternative to the hydrophobic membrane and the hydrophilic membrane, a porous membrane can be disposed within the pore. In some embodiments, the porous membrane can be configured to allow air to pass through but not blood to pass through.

[0014] In some embodiments, the distal end of the catheter can include a notch configured to receive blood. In some embodiments, the notch can be in fluid communication with a blood flashback chamber. In some embodiments, the needle assembly can include a grip extending outwardly from the needle hub and distal to the distal end of the needle hub. In some embodiments, the introducer needle can include multiple inner diameters.

[0015] In some embodiments, a method of sampling or collecting blood may include inserting a catheter system into a patient's vasculature. In some embodiments, the method may include coupling a blood collection device to a proximal portion of a stopper. In some embodiments, the method may include collecting blood from the vasculature within the blood collection device. In some embodiments, the method may include priming the catheter system prior to inserting the catheter system into the vasculature. In some embodiments, the distal portion of the catheter may include a notch in fluid communication with a blood flashback chamber, and blood from the vasculature may be collected within the blood collection device without discarding a blood sample.

[0016] It should be understood that the above summary and the following detailed description are merely exemplary and illustrative and do not limit the invention protected by the claims. It should be understood that the various embodiments are not limited to the arrangements and means shown in the drawings. It should also be understood that the embodiments may be combined, other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the present invention, unless otherwise protected by the claims. Therefore, the following detailed description should not be considered limiting. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The exemplary embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0018] Figure 1A is an upper perspective view of an exemplary catheter system in an insertion configuration ready for insertion into a patient, according to some embodiments;

[0019] Figure 1B is an upper perspective view of an exemplary needle hub according to some embodiments, with an exemplary introducer needle removed;

[0020] Figure 1C According to some embodiments Figure 1B A cross-sectional view of a needle seat;

[0021] Figure 1D According to some embodiments Figure 1B a cross-sectional view of a needle hub showing an introducer needle press-fitted within an exemplary through-hole of the needle hub;

[0022] Figure 1E is an upper perspective view of an exemplary stopper according to some embodiments;

[0023] Figure 1F is coupled to Figure 1B The needle holder Figure 1E A cross-sectional view of the plug;

[0024] Figure 2A According to some embodiments Figure 1E a lower perspective view of the plug showing an exemplary vent;

[0025] Figure 2B According to some embodiments Figure 2A a cross-sectional view of a plug;

[0026] Figure 3A According to some embodiments Figure 1E A lower perspective view of the plug showing another exemplary vent;

[0027] Figure 3B According to some embodiments Figure 3A a cross-sectional view of a plug;

[0028] Figure 4A is an upper perspective view of another exemplary catheter system in an insertion configuration ready for insertion into a patient, according to some embodiments;

[0029] Figure 4B is an upper perspective view of another exemplary needle hub according to some embodiments, with an exemplary introducer needle removed;

[0030] Figure 4C According to some embodiments Figure 4B A cross-sectional view of a needle seat;

[0031] Figure 4D According to some embodiments Figure 4B a cross-sectional view of a needle hub showing an introducer needle press-fitted within an exemplary through-hole of the needle hub;

[0032] Figure 4E is an upper perspective view of another exemplary stopper according to some embodiments;

[0033] Figure 4F is coupled to Figure 4B The needle holder Figure 4E A cross-sectional view of the plug;

[0034] Figure 5A is a cross-sectional view of an exemplary catheter according to some embodiments;

[0035] Figure 5B According to some embodiments Figure 5B a top view of the catheter; and

[0036] Figure 6 is a cross-sectional view of an exemplary introducer needle according to some embodiments. DETAILED DESCRIPTION

[0037] All examples and conditional language described herein are intended to be used for teaching purposes to help readers understand the present invention and the concepts contributed by the inventor to facilitate this field, and are to be interpreted as not being limited to such specific examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and modifications may be made thereto without departing from the spirit and scope of the present invention.

[0038] Now refer to Figure 1A In some embodiments, the catheter system 10 can include a catheter assembly 12, which can include a catheter adapter 14 and a catheter 16. In some embodiments, the catheter adapter 14 can include a distal portion 18, a proximal portion 20, and a lumen extending through the distal portion 18 and the proximal portion 20. In some embodiments, the catheter 16 can be secured within the catheter adapter 14 and can extend distally from the distal portion 18 of the catheter adapter 14.

[0039] In some embodiments, the catheter system 10 can include a needle assembly 22, which can include a needle hub 24. In some embodiments, the needle hub 24 can include a distal portion coupled to the proximal portion 20 of the catheter adapter 14. In some embodiments, the needle assembly 22 can include an introducer needle 25 that can extend through the catheter 16 when the catheter system 10 is in the insertion configuration, ready for insertion into the patient's vasculature.

[0040] In some embodiments, the introducer needle 25 may include a sharp distal tip that can assist in penetrating the vasculature. In some embodiments, the catheter system 10 may include a stopper 26 coupled to the proximal end of the needle hub 24. In some embodiments, the needle assembly 22 may include a grip 28 that can extend outwardly from the needle hub 24 to the distal end of the needle hub 24.

[0041] In some embodiments, the catheter system 10 may include a peripheral intravenous catheter system ("PIVC"), such as a BDNEXIVA TM Closed venous catheter system, BD CATHENA TM Catheter system, BD VENFLON TM Pro safety protection intravenous catheter system, BD NEOFLON TM Intravenous cannula system, BD INSYTE TM AUTOGUARD TM BC guard intravenous catheter system or another suitable peripheral intravenous catheter system.In some embodiments, the catheter system 10 can include a peripherally inserted central catheter ("PICC") system or a midline catheter system.

[0042] Now refer to Figures 1B to 1F In some embodiments, the needle hub 24 may include a proximal portion 30. In some embodiments, the needle hub 24 may include a wall 32, which may be disposed at the distal portion 34 of the needle hub 24 or between the distal portion 34 of the needle hub 24 and the proximal portion 30 of the needle hub 24. In some embodiments, the needle hub 24 may include a through hole 36. In some embodiments, the needle hub 24 may include a blood flashback chamber 38 that may extend through the proximal portion 30 of the needle hub 24. In some embodiments, the through hole 36 may be disposed at the distal end of the blood flashback chamber 38. In some embodiments, the wall 32 may include the through hole 36. In some embodiments, the blood flashback chamber 38 may be proximal to the wall 32. In some embodiments, the needle hub 24 may be transparent, which may allow visualization of blood within the blood flashback chamber 38.

[0043] In some embodiments, the introducer needle 25 can be press-fitted into the through-hole 36. More specifically, in some embodiments, the outer diameter of the proximal portion of the introducer needle 25 can be slightly larger than the diameter of the through-hole 36 so that the introducer needle 25 and the through-hole 36 interfere with each other. In some embodiments, the proximal portion of the introducer needle 25 can be disposed within a flashback chamber 38 such that, in response to the introducer needle 25 being inserted into the patient's vasculature, blood can flow through the introducer needle 25 and into the flashback chamber 38, where the blood is visible to the user.

[0044] In some embodiments, the plug 26 can plug the proximal opening 40 of the blood flashback chamber 38 and provide venting of the blood flashback chamber 38. In some embodiments, the plug 26 can include a distal portion 42, a proximal portion 44, a lumen 46 extending through the distal portion 42 of the plug 26 and the proximal portion 44 of the plug 26, and a tubular section 48 disposed between the distal portion 42 of the plug 26 and the proximal portion 44 of the plug 26. In some embodiments, the distal portion 42 of the plug 26 can include a neck portion 50 and / or a skirt portion 52, each of which can extend from the tubular section 48 to define an annular channel 54 between the skirt portion 52 and the neck portion 50.

[0045] In some embodiments, the neck portion 50 can be inserted into the proximal end portion 30 of the needle hub 24 and can be securely fitted within the proximal end portion 30 of the needle hub 24. In some embodiments, the outer surface of the neck portion 50 can include one or more vent channels 56 that can be configured to provide venting of the blood flashback chamber 38. In some embodiments, the vent channels 56 can be configured to allow air to pass through, but not blood to pass through.

[0046] In some embodiments, the proximal portion 44 of the stopper 26 can include a luer adapter 58. In some embodiments, the proximal portion 44 of the stopper 26 can include a septum 60 that can be disposed within the luer adapter 58. In some embodiments, the vent channel 56 can facilitate the flow of blood through the introducer needle and into the blood flashback chamber and the stopper 26. In some embodiments, the stopper 26 can facilitate the collection of blood from the blood flashback chamber via a blood collection device that can be connected to the luer adapter 58.

[0047] In some embodiments, a method of drawing or collecting blood can include inserting the catheter system 10 into the patient's vasculature. In some embodiments, the method can include coupling a blood collection device to the proximal end 44 of the plug 26. In some embodiments, the method can include collecting blood from the vasculature within the blood collection device. In some embodiments, the method can include infusing the catheter system 10 prior to inserting the catheter system 10 into the vasculature.

[0048] In some embodiments, the septum 60 can include a proximal portion 62 that can be positioned externally to the luer adapter 58. In some embodiments, the septum 60 can include a distal portion 64 that can extend across the tubular segment 48. In some embodiments, the septum 60 can include a middle portion 66 that can be positioned between the proximal portion 62 and the distal portion 64. In some embodiments, the septum 60 can include a slit 68 that can extend longitudinally through the proximal portion 62, the distal portion 64, and the middle portion 66. In some embodiments, the cross-sections of the proximal portion 62, the distal portion 64, and the middle portion 66 can form a generally H-shape. In some embodiments, the distal portion 64 can be clamped within the plug 26 to secure the septum 60 within the plug 26, but it should be understood that the septum 60 can be secured within the plug 26 by other means.

[0049] Now refer to Figures 2A to 2B In some embodiments, a portion of the wall of the tubular section 48 can include an aperture 70 extending through the wall. In some embodiments, a hydrophobic membrane 72 can be disposed within the aperture 70 toward the exterior of the plug 26. In some embodiments, a hydrophilic membrane 74 can be disposed within the aperture 70 toward the interior of the plug 26 and / or adjacent to the hydrophobic membrane 72. In some embodiments, the hydrophilic membrane 74 can prevent fluid from leaking through the aperture 70, and the hydrophobic membrane 72 can provide venting of the blood return chamber. In some embodiments, after the hydrophobic membrane 72 is wetted by blood, the hydrophobic membrane 72 loses its ability to vent air and acts as a barrier to prevent ambient air from entering the plug 26. When negative pressure is applied, blood can then be collected using a blood collection device such as a tube or syringe.

[0050] In some embodiments, the aperture 70 can be distal to the distal portion 64 of the septum 60. In some embodiments, the aperture 70 can be elongated and / or curved along the shape of the flange of the tubular section 48. In some embodiments, the aperture 70 can be another suitable shape. In some embodiments, the hydrophobic membrane 72 can facilitate blood flow through the introducer needle and into the blood flashback chamber and the plug 26.

[0051] Now refer to Figures 3A to 3B , in some embodiments, as relative to Figures 2A to 2B Instead of the hydrophobic membrane and the hydrophilic membrane, a porous membrane 76 can be disposed within the hole 70. In some embodiments, the porous membrane 76 can be configured to allow air to pass through but not blood to pass through. In some embodiments, the porous membrane 76 can facilitate blood flow through the introducer needle 25 and into the blood flashback chamber and the plug 26.

[0052] Now refer to Figures 4A to 4D , in terms of one or more of the included components and / or operations, the catheter system 78 may be similar to that of the Figures 1A to 3BIn some embodiments, the catheter system 78 can include a plug 80. In some embodiments, the plug 80 can be similar to or identical to the catheter system 10 described above. Figures 1A to 3B The stopper 26 is similar or identical to that described above. In some embodiments, the needle hub 24 can be configured to be inserted into the catheter adapter 14, such as Figures 1B to 1D In other embodiments, the catheter adapter 14 can be configured to be inserted into the distal cavity 82 of the needle hub 24, such as, for example Figures 4B to 4D shown.

[0053] Now refer to Figures 4E to 4F In some embodiments, the diaphragm 60 of the stopper 80 can include an elastically deformable piston element. In some embodiments, the piston element includes a piston head 84 coupled to one or more bellows 86, which can form an accordion shape. In some embodiments, the piston head 84 can include a slit or hole. In some embodiments, in response to the blood collection device being coupled to the Luer adapter 58, the piston head 84 can move distally and the bellows 86 can compress. In some embodiments, in response to the compression of the bellows 86, the diaphragm 60 can open to allow blood to flow through the diaphragm 60 and into the blood collection device.

[0054] Now refer to Figures 5A to 5B In some embodiments, the distal end of the catheter 16 can include a hole or notch 88 configured to receive blood in response to inserting the distal end of the catheter 16 into the patient's vasculature. In some embodiments, the catheter system 10 and / or the catheter system 78 can include a catheter 16 having a notch 88. In some embodiments, the notch 88 can be in fluid communication with a blood flashback chamber. In more detail, in some embodiments, blood can flow into the notch 88 in a proximal direction and flow between the inner surface of the catheter 16 and the introducer needle. The blood can exit the proximal end of the introducer needle, flow into the blood flashback chamber, and then flow into the blood flashback chamber relative to the catheter 16. Figures 1A to 3B The plug 26 or relative to Figures 4A to 4F In the plug 80.

[0055] In some embodiments, the distal end of the catheter 16 may include a notch 88 in fluid communication with a blood flashback chamber, and blood from the vasculature may be collected within a blood collection device without discarding a blood sample. In some embodiments, a discarded blood sample may not be necessary because the notch 88 is located in the catheter 16 rather than on the introducer needle, and thus the infusion solution may not enter the introducer needle.

[0056] Now refer to Figure 6In some embodiments, the introducer needle 25 can include multiple inner diameters. In some embodiments, the inner surface of the introducer needle 25 can include one or more stepped portions 90, where the inner diameter of the introducer needle 25 can increase. In some embodiments, the stepped portion 90 can facilitate increased blood flow through the introducer needle 25. In some embodiments, the catheter system 10 and / or the catheter system 78 can include an introducer needle 25 having a stepped portion 90.

[0057] The present invention may be embodied in other specific forms without departing from the structure, method or other essential characteristics as broadly described herein and claimed hereinafter. The described embodiments are to be considered in all respects as illustrative only and not restrictive. The scope of the present invention is therefore indicated by the appended claims rather than the foregoing description. All variations within the meaning and range of equivalents of the claims are intended to be included within their scope.

Claims

1. A catheter system, comprising: A catheter assembly, comprising: a catheter adapter comprising a distal end, a proximal end, and a lumen extending through the distal end and the proximal end of the catheter adapter; and a catheter secured within the catheter adapter and extending distally from a distal end portion of the catheter adapter; and A needle assembly, the needle assembly comprising: A needle hub, comprising: a distal portion, the distal portion of the needle hub being coupled to the proximal portion of the catheter adapter; proximal end; a wall extending between a distal end of the hub and a proximal end of the hub; a flashback chamber proximate the wall and extending through a proximal end of the needle hub; and a through hole provided at a distal end of the blood flashback chamber and located within the wall; and an introducer needle comprising a proximal portion having an outer diameter greater than a diameter of the through hole, wherein the introducer needle is press-fitted into the through hole; a stopper coupled to a proximal end of the needle hub, wherein the stopper blocks a proximal opening of the blood flashback chamber and provides venting of the blood flashback chamber, wherein the stopper comprises a distal end, a proximal end, and a lumen extending through the distal end and the proximal end of the stopper, wherein the proximal end of the stopper comprises a Luer adapter and a septum disposed within the Luer adapter, wherein, in response to a blood collection device being coupled to the Luer adapter, the septum opens to allow blood to flow through the septum and into the blood collection device.

2. The catheter system according to claim 1, wherein The stopper includes a tubular section disposed between a distal end portion of the stopper and a proximal end portion of the stopper, wherein the distal end portion of the stopper includes a neck portion extending from the tubular section and a skirt extending from the tubular section to define an annular channel between the skirt and the neck portion, wherein the neck portion is inserted into the proximal end portion of the needle holder, and wherein an outer surface of the neck portion includes a plurality of exhaust channels configured to provide exhaust of the blood flashback chamber.

3. The catheter system of claim 2, wherein: The diaphragm includes an elastically deformable piston element, wherein the piston element includes a piston head coupled to a plurality of bellows, wherein the piston head includes a slit or aperture.

4. The catheter system of claim 1 , wherein: The stopper further comprises a tubular section disposed between a distal end portion of the stopper and a proximal end portion of the stopper, wherein the distal end portion of the stopper comprises a neck portion extending from the tubular section and a skirt portion extending from the tubular section to define an annular channel between the skirt portion and the neck portion, wherein the neck portion is inserted into the proximal end portion of the needle holder, wherein a portion of a wall of the tubular section comprises a hole, a hydrophobic membrane disposed within the hole facing the outside of the stopper, and a hydrophilic membrane disposed within the hole facing the inside of the stopper, wherein the hydrophilic membrane prevents fluid from leaking through the hole, and wherein the hydrophobic membrane provides venting of the blood flashback chamber.

5. The catheter system of claim 4, wherein: The septum includes a proximal portion disposed on the exterior of the Luer adapter, a distal portion extending across the tubular section, an intermediate portion between the proximal and distal portions, and a slit extending longitudinally through the proximal, distal, and intermediate portions, wherein the proximal, distal, and intermediate portions form a generally H-shape in cross-section, and wherein the aperture is distal to the distal portion of the septum.

6. The catheter system of claim 1, wherein: The stopper further comprises a tubular section disposed between a distal end portion of the stopper and a proximal end portion of the stopper, wherein the distal end portion of the stopper comprises a neck portion extending from the tubular section and a skirt extending from the tubular section to define an annular channel between the skirt and the neck portion, wherein the neck portion is inserted into the proximal end portion of the needle hub, wherein a portion of a wall of the tubular section comprises a hole, wherein a porous membrane is disposed within the hole, wherein the porous membrane is configured to allow air to pass therethrough but not blood to pass therethrough.

7. The catheter system of claim 6, wherein: The septum includes a proximal portion disposed on the exterior of the Luer adapter, a distal portion extending across the tubular section, an intermediate portion between the proximal and distal portions, and a slit extending longitudinally through the proximal, distal, and intermediate portions, wherein the proximal, distal, and intermediate portions form a generally H-shape in cross-section, and wherein the aperture is distal to the distal portion of the septum.

8. The catheter system of claim 1, wherein: The distal end of the catheter includes a notch, wherein the notch is in fluid communication with the blood flashback chamber.

9. The catheter system of claim 1 , wherein: The needle assembly also includes a grip extending outwardly from the needle hub to a distal side of the distal end of the needle hub.

10. The catheter system of claim 1, wherein: The introducer needle includes multiple inner diameters.

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