CATHETER SYSTEM TO FACILITATE BLOOD COLLECTION AND RELATED METHODS

Abstract

A catheter system may include a catheter adapter, which may include a distal end, a proximal end, a lumen extending through the distal end and the proximal end, and a side port in fluid communication with the lumen. A catheter may extend distally from the catheter adapter. A septum may be disposed within the lumen. The septum may include a first slit generally aligned with a longitudinal axis of the catheter and a second slit offset from the longitudinal axis of the catheter. An introducer needle may be secured within a needle hub and may extend through the catheter and the first slit of the septum. A winged needle set may include: a body; a needle extending distally from the body and through the second slit of the septum; an extension tube extending from the body; and a blood collection device coupled to the extension tube.

Claims

1. A catheter system, comprising: a catheter adapter, comprising a distal end, a proximal end, a lumen extending through the distal end and the proximal end, and a side port in fluid communication with the lumen; a catheter extending distally from the catheter adapter; a septum disposed within the lumen of the catheter adapter, wherein the septum comprises a first slit and a second slit generally parallel to the first slit, wherein the first slit is generally aligned with a longitudinal axis of the catheter, wherein the second slit is offset from the longitudinal axis of the catheter; a needle hub; and an introducer needle secured within the needle hub, wherein the introducer needle is aligned with a longitudinal axis of the catheter and extends through the catheter and the first slit of the septum.

2. The catheter system of claim 1, wherein the septum comprises a generally elliptical shape with a cut along a plane angled with respect to the longitudinal axis of the catheter.

3. The catheter system of claim 2, wherein the cut forms a first face at a distal end of the septum, wherein the distal end of the septum comprises the first face and a second face, wherein the second face is proximate the first face and generally perpendicular to the longitudinal axis of the catheter.

4. The catheter system of claim 3, wherein the septum comprises a tunnel extending along the first face, wherein the tunnel extends from the side port towards the longitudinal axis of the catheter.

5. The catheter system of claim 1, wherein the catheter adapter comprises a slot aligned with the second slit and extending from a proximal end of the catheter adapter.

6. The catheter system of claim 5, further comprising a winged needle set, comprising: a body; a tab extending outwardly from the body, wherein the tab is disposed within the slot; a needle extending distally from the body and through the second slit of the septum; an extension tube extending from the body.

7. The catheter system of claim 6, wherein the winged needle set further comprises: an adapter coupled to a proximal end of the extension tube; and a plug plugging a proximal end of the adapter, wherein the proximal end of the plug is configured to couple to a blood collection device, wherein the plug provides air venting of the winged needle set.

8. The catheter system of claim 6, wherein a distal end of the needle is blunt.

9. The catheter system of claim 6, wherein a distal end of the needle is sharp.

10. The catheter system of claim 1, wherein the proximal end of the catheter adapter comprises a proximal opening, wherein the longitudinal axis of the catheter is offset from a center of the proximal opening.

11. A method of collecting blood, comprising: priming a portion of a catheter system to a prime stop point, wherein the catheter system comprises: a catheter adapter, comprising a distal end, a proximal end, a lumen extending through the distal end and the proximal end, and a side port in fluid communication with the lumen, wherein the prime stop point is proximate the side port; a catheter extending distally from the catheter adapter; a septum disposed within the lumen of the catheter adapter, wherein the septum comprises a first slit and a second slit generally parallel to the first slit, wherein the first slit is generally aligned with a longitudinal axis of the catheter, wherein the second slit is offset from the longitudinal axis of the catheter; a needle hub; an introducer needle secured within the needle hub, wherein the introducer needle is aligned with a longitudinal axis of the catheter and extends through the catheter and the first slit of the septum; after priming the portion of the catheter system to the prime stop point, inserting the catheter system into vasculature of a patient; after inserting the catheter system into vasculature of the patient, removing the needle hub and introducer needle from the catheter system; after removing the needle hub and the introducer needle from the catheter system, collecting blood using a winged needle set, wherein the winged needle set comprises: a body; a needle extending distally from the body and through the second slit of the septum; an extension tube extending from the body; an adapter coupled to a proximal end of the extension tube; after collecting blood using the winged needle set, removing the winged needle set from the catheter system.

12. The method of claim 11, wherein when the winged needle set is removed from the catheter system, blood is disposed within the lumen distal to the septum and proximate the prime stop point.

13. The method of claim 11, wherein the septum comprises a generally elliptical shape with a cut along a plane angled with respect to the longitudinal axis of the catheter.

14. The method of claim 13, wherein the cut forms a first face at a distal end of the septum, wherein the distal end of the septum comprises the first face and a second face, wherein the second face is proximate the first face and generally perpendicular to the longitudinal axis of the catheter.

15. The method of claim 13, wherein the septum comprises a tunnel extending along the first face, wherein the tunnel extends from the side port towards the longitudinal axis of the catheter.

16. The method of claim 11, wherein the catheter adapter comprises a slot aligned with the second slit and extending from a proximal end of the catheter adapter, wherein the winged needle set further comprises a tab extending outwardly from the body, wherein the tab is disposed within the slot.

17. The method of claim 11, wherein the winged needle set further comprises a plug plugging a proximal end of the adapter, wherein the proximal end of the plug is configured to couple to a blood collection device, wherein the plug provides air venting of the winged needle set.

18. The method of claim 17, wherein a distal end of the needle is blunt.

19. The method of claim 17, wherein a distal end of the needle is sharp.

20. The method of claim 11, wherein the proximal end of the catheter adapter comprises a proximal opening, wherein the longitudinal axis of the catheter is offset from a center of the proximal opening.

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0014] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0015] FIG. 1A is an upper perspective view of an example catheter system, according to some embodiments;

[0016] FIG. 1B is an upper perspective view of the catheter system 1A with an example needle assembly and an example winged needle set removed, according to some embodiments;

[0017] FIG. 1C is an exploded view of the catheter system of FIG. 1A, according to some embodiments;

[0018] FIG. 2A is an enlarged upper perspective view of a portion of the catheter system of FIG. 1A, according to some embodiments;

[0019] FIG. 2B is an enlarged cross-sectional view of the portion of FIG. 2A, according to some embodiments;

[0020] FIG. 2C is another enlarged upper perspective view of a portion of the catheter system of FIG. 1A, illustrating an example catheter adapter removed for illustration purposes, according to some embodiments;

[0021] FIG. 2D is an upper perspective view of an example septum of the catheter system of FIG. 1A, according to some embodiments;

[0022] FIG. 2E is an upper perspective view of the catheter system of FIG. 1A, illustrating the needle assembly removed from the catheter system, according to some embodiments;

[0023] FIG. 2F is an upper perspective view of the catheter system of FIG. 1A, illustrating the needle assembly and the winged needle set removed from the catheter system after blood draw, according to some embodiments;

[0024] FIG. 3A is an upper perspective view of the winged needle set of the catheter system of FIG. 1A, according to some embodiments;

[0025] FIG. 3B is an upper perspective view of an example distal end of the winged needle set of the catheter system of FIG. 1A, according to some embodiments;

[0026] FIG. 3C is an upper perspective view of another example distal end of the winged needle set of the catheter system of FIG. 1A, according to some embodiments;

[0027] FIG. 4A is an upper perspective view of another catheter system, according to some embodiments;

[0028] FIG. 4B is an upper perspective view of the catheter system of FIG. 4A, illustrating an example needle assembly and example winged needle set removed, according to some embodiments;

[0029] FIG. 4C is an upper perspective view of another catheter system, according to some embodiments; and

[0030] FIG. 4D is an upper perspective view of the catheter system of FIG. 4C, illustrating an example plug replaced with an example needleless connector, according to some embodiments.

DESCRIPTION OF EMBODIMENTS

[0031] All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the invention and the concepts contributed by the inventor to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present inventions have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the invention.

[0032] Referring now to FIGS. 1A-1C, in some embodiments, a catheter system 10 may include a catheter adapter 12, which may include a distal end 14, a proximal end 16, a lumen 18 extending through the distal end 14 and the proximal end 16, and a side port 20 in fluid communication with the lumen 18. In some embodiments, the catheter system 10 may include a catheter 22 secured within the catheter adapter 12 and extending distally from the catheter adapter 12.

[0033] In some embodiments, the catheter system 10 may include a septum 24 disposed and secured within the lumen 18 of the catheter adapter 12. In some embodiments, the septum 24 may include a first slit 26 and/or a second slit 28, which may be generally parallel to the first slit 26. In some embodiments, the first slit 26 may be generally aligned with a longitudinal axis 30 of the catheter 22. In some embodiments, the second slit 28 may be offset from the longitudinal axis 30 of the catheter 22. In some embodiments, the proximal end 16 of the catheter adapter 12 may include a proximal opening 32. In some embodiments, the longitudinal axis 30 of the catheter 22 may be offset from a center of the proximal opening 32. In some embodiments, an outer surface of the catheter adapter 12 and/or the lumen 18 may include a generally elliptical shape.

[0034] In some embodiments, the catheter system 10 may include a needle assembly, which may include a needle hub 36 and an introducer needle 38 secured within the needle hub 36. In some embodiments, the introducer needle 38 may be aligned with the longitudinal axis 30 of the catheter 22. In some embodiments, the introducer needle 38 may extend through the catheter 22 and the first slit 26 of the septum 24. In some embodiments, the introducer needle 38 may extend distally beyond a distal end of the catheter 22. In some embodiments, the introducer needle 38 may include a sharp distal tip, which may be used to puncture vasculature of a patient.

[0035] In some embodiments, the catheter system 10 may include a winged needle set 40, which may include one or more of the following: a body 42; a tab 44 extending outwardly from the body 42; a needle 46 extending distally from the body 42 and through the second slit 28 of the septum 24; and an extension tube 48 extending from the body 42. In some embodiments, the catheter adapter 12 may include a slot 50 aligned with the second slit 28 and extending from the proximal end 16 of the catheter adapter 12. In some embodiments, the tab 44 may be disposed within the slot 50. In some embodiments, the slot 50 may help secure the tab 44 and the winged needle set 40 within the catheter adapter 12. In some embodiments, the tab 44 may facilitate removal of the winged needle set 40 from the catheter system 10 after blood is collected from the vasculature of the patient through the winged needle set 40.

[0036] In some embodiments, the winged needle set 40 may include an adapter 52, which may be coupled to a proximal end of the extension tube 48. In some embodiments, the proximal end of the extension tube 48 may be integrated into the adapter 52. In some embodiments, the adapter 52 may include a luer adapter, which may be straight, or another suitable adapter. In some embodiments, the winged needle set 40 may include a plug 54 plugging a proximal end of the adapter 52. In some embodiments, a proximal end of the plug 54 may be configured to couple to a blood collection device. In some embodiments, the plug 54 may include a BD VACUTAINER adapter. In some embodiments, the blood collection device may include a blood collection tube, a BD VACUTAINER tube or similar tube, which may include a hermetic seal at an open end and a vacuum.

[0037] In some embodiments, the proximal end of the plug 54 may include a cannula, which may extend in a proximal direction from the plug 54. In some embodiments, an elastomeric sheath 58 may be coupled to the plug 54, and a proximal end of the cannula may be enveloped within the elastomeric sheath 58. In some embodiments, the elastomeric sheath 58 may include an open distal end and a closed proximal end. In some embodiments, in response to the blood collection device pushing the elastomeric sheath 58 distally, the cannula may pierce the elastomeric sheath 58, and the cannula may insert into the blood collection device. In some embodiments, the plug 54 may include any suitable plug configured to couple to the blood collection device. In some embodiments, the adapter 52 may be coupled to the blood collection device via the plug 54.

[0038] In some embodiments, the plug 54 may provide air venting of the winged needle set 40 and the catheter system 10. In some embodiments, plug 54 may include a vent 56, which may include a porous membrane, microgroove, or any other suitable vent configured to pass air but not blood. In some embodiments, the vent 56 may be configured to provide continuous blood flashback due to air exiting the catheter system 10 at the vent 56.

[0039] In some embodiments, the introducer needle 38 may be constructed of metal or another suitable material. In some embodiments, the catheter 22 and/or the catheter adapter 12 may be constructed of constructed of polyisoprene, polyimide, latex, polyurethane, nylon, polyethylene, plastic, or another suitable material. In some embodiments, the septum 24 may be constructed of an elastomer. For example, the septum 24 may be constructed of silicon or another suitable material. In some embodiments, the septum 24 may be monolithically formed as a single unit.

[0040] In some embodiments, a distal end of an extension tube 60 may be integrated with the side port 20 of the catheter adapter 12. In some a proximal end of the extension tube 60 may be integrated with an adapter 62, which may include a luer adapter or another suitable adapter. In some embodiments, the adapter 62 may be coupled to a needleless connector 64 such as the BD SMARTSITE Needle-free Connector, the BD MAXZERO Needle-free Connector, or the BD Q-SYTE Needle-free Connector, for example. In some embodiments, a fluid infusion or priming device (such as, for example, a syringe) may be coupled to the needleless connector 64. In some embodiments, a pinch clamp 66 may be coupled to the extension tube 60 and configured to occlude or block fluid from flowing through the extension tube 60 in response to the pinch clamp 66 being in a clamped or closed position.

[0041] In some embodiments, a method of collecting blood may include priming a portion of the catheter system 10 to a prime stop point 68. In some embodiments, the prime stop point 68 may be proximate the side port 20. In some embodiments, the prime stop point 68 may be disposed outside the side port 20 and generally flush with an outer opening of the side port 20, such that the prime stop point 68 may be visible to a user.

[0042] In some embodiments, a priming device may be coupled to the needleless connector 64 and the catheter system 10 may be primed from the needleless connector 64 to the prime stop point 68. In some embodiments, in response to the catheter system 10 being primed from the needleless connector 64 to the prime stop point 68, the pinch clamp 66 may be moved to the closed position. In some embodiments, a priming solution 70 may include saline or another suitable material. In some embodiments, after priming the portion of the catheter system 10 to the prime stop point 68, the catheter system 10 may be inserted into vasculature of the patient. In particular, the catheter 22 and the introducer needle 38 may be inserted into the vasculature of the patient.

[0043] FIG. 1A illustrates the catheter system 10 after being primed to the prime stop point 68 and inserted into the vasculature of the patient, according to some embodiments. In some embodiments, the pinch clamp 66 may remain in the closed position during and/or after insertion of the catheter system 10 into the vasculature. In some embodiments, in response to inserting the catheter system 10 into the vasculature of the patient, blood 72 may flow through a notch in the introducer needle 38 or the catheter 22 into a space between the introducer needle 38 and the catheter 22. The blood 72 may then travel proximally into the lumen 18 distal to the septum 24. In some embodiments, the blood 72 may flow proximally to the prime stop point 68 and there may be some diffusion into the priming solution 70. In some embodiments, when the needle 46 of the winged needle set 40 extends through the septum 24, the blood 72 may flow through the winged needle set 40. In some embodiments, the blood 72 may correspond to blood flashback, indicating to the user presence of the catheter 22 within the vasculature.

[0044] In some embodiments, the needle assembly may be removed from the catheter system 10, which may facilitate more rapid blood collection through the catheter 22. In these embodiments, the blood 72 may flow through the catheter 22, which may not include the introducer needle 38 extending there through. In some embodiments, when the needle 46 of the winged needle set 40 extends through the septum 24, the blood 72 may flow through the winged needle set 40 and into the blood collection device.

[0045] As illustrated in FIG. 1B, for example, after inserting the catheter system 10 into vasculature of the patient, the needle hub 36 and the introducer needle 38 may be removed from the catheter system 10. In some embodiments, after removing the needle hub 36 and the introducer needle 38 from the catheter system 10, the blood 72 may be collected using the winged needle set 40. In some embodiments, after collecting the blood 72 using the winged needle set 40, the winged needle set 40 may be removed from the catheter system 10. In some embodiments, after collecting the blood 72 using the winged needle set 40, the winged needle set 40 may remain coupled to the catheter adapter 12, extending through the septum 34, for use in infusion. In some embodiments, when the winged needle set 40 is removed from the catheter system 10, blood may be disposed within the lumen 18 distal to the septum 24 and proximate the prime stop point 68.

[0046] Referring now to FIGS. 2A-2F, in some embodiments, the septum 24 may include a generally elliptical shape with a cut along a plane 74 angled with respect to the longitudinal axis 30 of the catheter 22. In some embodiments, the cut may form a first face 76 at a distal end 78 of the septum. In some embodiments, the distal end 78 of the septum 24 may include the first face 76 and a second face 80. In some embodiments, the second face 80 may be proximate the first face 76 and/or generally perpendicular to the longitudinal axis 30 of the catheter 22. In some embodiments, the first slit 26 and/or the second slit 28 may extend from a proximal end 82 of the septum 24. In some embodiments, the proximal end 82 may be generally oval-shaped.

[0047] In some embodiments, the septum 24 may include a groove or tunnel 84 extending along and/or through the first face 76. In some embodiments, the tunnel 84 may extend from the side port 20 towards the longitudinal axis 30 of the catheter. In some embodiments, the tunnel 84 may facilitate flow of fluid between the side port 20 and the lumen 18.

[0048] FIG. 2E illustrates the catheter system 10 after being primed to the prime stop point 68 and inserted into the vasculature of the patient, according to some embodiments. In some embodiments, as illustrated in FIG. 2F, after inserting the catheter system 10 into vasculature of the patient, the needle hub 36 and the introducer needle 38 may be removed from the catheter system 10. In some embodiments, when the winged needle set 40 is removed from the catheter system 10, the blood 72 may be disposed within the lumen 18 distal to the septum 24 and proximate the prime stop point 68.

[0049] Referring now to FIGS. 3A-3C, the winged needle set 40 is illustrated, according to some embodiments. In some embodiments, a distal end of the needle 46 may be blunt (as illustrated, for example, in FIG. 3B) or sharp (as illustrated, for example, in FIG. 3C). In some embodiments, the catheter system 10 may provide the freedom to use a needle 46 that has a larger size or gauge than the introducer needle 38, which in some cases may be restricted to 24g or 26g, depending on the application. Thus, the needle 46 may facilitate a higher flow rate and/or reduction in hemolysis. In some embodiments, the catheter system 10 may be preassembled with the winged needle set 40 extending through the septum 24, which may reduce potential contamination and/or increase user-friendliness.

[0050] Referring now to FIGS. 4A-4B, another catheter system 85 is illustrated, according to some embodiments. In some embodiments, the catheter system 85 may be similar or identical to the catheter system 10 described with respect to FIGS. 1-3 in terms of one or more included components and/or operation. In some embodiments, the winged needle set 40 may be inserted into another side port 86, which may be in fluid communication with the lumen 18. In some embodiments, the other side port 86 through which the winged needle set 40 may be inserted may facilitate flushing of residual blood after blood collection. In some embodiments, a septum 88 disposed within the other side port 86 and/or the lumen 18 may be configured such that the winged needle set 40 inserts through the septum to communicate with the lumen 18. In some embodiments, the introducer needle 38 may be inserted through the septum 88 or another septum disposed within the lumen 18.

[0051] Referring now to FIGS. 4C-4D, another catheter system 90 is illustrated, according to some embodiments. In some embodiments, the catheter system 90 may be similar or identical in terms of one or more included components and/or operation to the catheter system 10 described with respect to FIGS. 1-3 and/or the catheter system 85 described with respect to FIG. 4. In some embodiments, a distal end of the extension tube 48 may be integrated with the other side port 86. In FIG. 4D, the plug 54 is replaced with a needleless connector 64 after blood is drawn from the vasculature of the patient, which may facilitate flushing. In some embodiments, one or more of the needleless connectors 64 may be used to flush the catheter system 90. In some embodiments, the dual-extension tube configuration of the catheter system 90 may facilitate immediate blood collection upon catheter insertion into the vasculature and parallel drug delivery. In some embodiments, at any point during an indwell period of the catheter system 90, blood draw may be initiated by replacing one of the needleless connectors 64 with a plug 54.

[0052] The present invention may be embodied in other specific forms without departing from its structures, methods, or other essential characteristics as broadly described herein and claimed hereinafter. The described embodiments are to be considered in all respects only as illustrative, and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.