Integrated Catheter System for Blood Draw at the Time of Placement and with Enabling Feature for Blood Draw During Indwell
20230210421 · 2023-07-06
Inventors
- Yiping Ma (Layton, UT, US)
- Jeff Charles O'Bryan (Murray, UT, US)
- Jonathan Karl Burkholz (Salt Lake City, UT, US)
- Curtis H. Blanchard (Herriman, UT, US)
Cpc classification
A61B5/15074
HUMAN NECESSITIES
A61M2039/1077
HUMAN NECESSITIES
A61B5/153
HUMAN NECESSITIES
A61B5/150389
HUMAN NECESSITIES
A61B5/150992
HUMAN NECESSITIES
A61M39/1011
HUMAN NECESSITIES
A61B5/155
HUMAN NECESSITIES
International classification
Abstract
An integrated peripheral intravenous (IV) catheter configured for blood draw both at the time of catheter placement and during catheter indwell. The peripheral IV catheter includes a catheter adapter having a catheter configured to be inserted into a patient's vasculature and a side inlet defining a fluid pathway into and out of the catheter. The peripheral IV catheter also includes a side port member having a main branch, the main branch including a distal end configured to couple the side port member to the side inlet of the catheter adapter and a connector portion accessible via a proximal end of the main branch. Additionally, the peripheral IV catheter includes a blood collection adapter removably and directly coupled to the connector portion of the side port member at the proximal end of the main branch. Furthermore, side pore member of the peripheral IV catheter may include a side branch.
Claims
1. An integrated peripheral intravenous (IV) catheter comprising: a catheter adapter comprising: a catheter configured to be inserted into a patient's vasculature, and a side inlet defining a fluid pathway into and out of the catheter; a side port member having a main branch, the main branch comprising a distal end configured to couple the side port member to the side inlet of the catheter adapter and a connector portion accessible via a proximal end of the main branch; and a blood collection adapter removably and directly coupled to the connector portion of the side port member at the proximal end of the main branch.
2. The integrated peripheral IV catheter of claim 1, further comprising a luer lock access device coupled to the blood collection adapter.
3. The integrated peripheral IV catheter of claim 2, wherein the luer lock access device comprises a needle assembly and blood collection container holder.
4. The integrated peripheral IV catheter of claim 1, wherein the connector portion is configured as a needle-free connector.
5. The integrated peripheral IV catheter of claim 1, wherein the connector portion is configured as a PRN connector.
6. The integrated peripheral IV catheter of claim 1, wherein the main branch of the side port member provides a fluid pathway for drawing blood from the patient's vasculature.
7. The integrated peripheral IV catheter of claim 1, wherein the side port member further comprises a side branch.
8. The integrated peripheral IV catheter of claim 7, further comprising an extension set coupled to the side port member via the side branch.
9. The integrated peripheral IV catheter of claim 8, wherein the main branch of the side port member provides a first fluid pathway for drawing blood from a patient's vasculature and the side branch of the side port member provides a second fluid pathway for injecting fluids into the patient's vasculature.
10. The integrated peripheral IV catheter of claim 1, wherein the blood collection adapter comprises a fluid pathway having a non-linear portion.
11. The integrated peripheral IV catheter of claim 10, wherein the non-linear portion is one of a coil shape or an S-shape.
12. The integrated peripheral IV catheter of claim 10, wherein the blood collection adapter is coupled to an extension tube and an access port.
13. The integrated peripheral IV catheter of claim 10, wherein the blood collection adapter is directly coupled to a blood collection device.
14. The integrated peripheral IV catheter of claim 13, wherein the blood collection device comprises a needle assembly having a needle configured to receive a blood collection container.
15. An integrated peripheral intravenous (IV) catheter comprising: a catheter adapter comprising: a catheter configured to be inserted into a patient's vasculature, and a side inlet defining a fluid pathway into and out of the catheter; a side port member comprising: a main branch having a distal end configured to couple the side port member to the side inlet of the catheter adapter and a connector portion accessible via a proximal end of the main branch, and a side branch; and a blood collection adapter directly coupled to the connector portion of the side port member at the proximal end of the main branch.
16. The integrated peripheral IV catheter of claim 15, wherein the main branch of the side port member provides a first fluid pathway for drawing blood from a patient's vasculature and the side branch of the side port member provides a second fluid pathway for injecting fluids into the patient's vasculature.
17. The integrated peripheral IV catheter of claim 15, wherein the blood collection adapter is configured to allow for drawing of blood from a patient's vasculature at the time of catheter placement.
18. The integrated peripheral IV catheter of claim 17, wherein the blood collection adapter is selectively removable from the connector portion of the main branch of the side port member.
19. The integrated peripheral IV catheter of claim 15, further comprising a luer lock access device coupled to the blood collection adapter.
20. The integrated peripheral IV catheter of claim 15, wherein the blood collection adapter comprises a fluid pathway having a non-linear portion.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0032]
[0033]
[0034]
[0035]
[0036]
[0037]
[0038]
DESCRIPTION OF PREFERRED EMBODIMENTS
[0039] The following description is provided to enable those skilled in the art to make and use the described aspects contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present disclosure.
[0040] For the purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawings. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the invention. Hence, specific dimensions and other physical characteristics related to the aspects disclosed herein are not to be considered as limiting.
[0041] Embodiments of the present disclosure will primarily be described in the context of integrated PIVCs. However, embodiments of the present disclosure equally extend to other integrated IV catheters. Accordingly, the techniques of the present disclosure can be applied to any type of integrated IV catheter. For purposes of the specification and the claims, an integrated IV catheter should be construed as an IV catheter that includes an integrated extension set.
[0042] Referring to
[0043] PIVC 100 also includes a side port member 130. The side port member 130 has two fluid pathways comprising a main branch 133 and a side branch 131. The main branch 133 is coupled to the side inlet 112 of catheter adapter 110 via intermediate tubing 113. However, in some embodiments, it is to be understood that main branch 133 may be coupled directly to side inlet 112, thereby obviating the need for intermediate tubing 113.
[0044] The side branch 131 is configured couple an extension set 140 with the side port member 130. As depicted, extension set 140 includes extension tubing 141 that extends between side branch 131 and an access port 143, and may include a pinch clamp 142 for occluding extension tubing 141. It is noted, however, that many different types and configurations of extension sets could be used. In this way, extension set 140 provides a means of fluid infusion via the PIVC 100.
[0045] Unlike side branch 131, main branch 133 of side port member 130 is not coupled to elongated extension tubing. Rather, main branch 133 incorporates a connector portion 134 configured as, e.g., a needle-free connector such as the SMARTSITE™ needle-free connector from Becton Dickinson & Company. However, it is to be understood that connector portion 134 may be any appropriate needle-free connector.
[0046] Referring still to
[0047] However, as noted above, the efficacy of blood collection via an indwelling catheter may diminish over time due to several factors such as, e.g., the possibility of catheter collapse, reduced blood flow due to debris built up on or within the catheter, etc. Thus, when it is desirable to draw blood via an indwelling catheter at any time other than immediately (or relatively soon) after catheter insertion, use of a device such as, e.g., a PIVO™ needle-less blood draw device is greatly beneficial, as it is configured to bypass any potential debris build up or other issues relating to the indwelling catheter.
[0048] As such, in accordance with an aspect of the present disclosure, not only is side port member 130 of PIVC 100 configured to allow for blood draw at the time of catheter insertion, as described above, but the connector portion 134 further allows for coupling to a device such as, e.g., a PIVO™ needle-less blood draw device for blood draw via the indwelling catheter at any time after catheter insertion. That is, the connector portion 134 of side port member 130 allows for the selective coupling and removal of various blood draw devices, not only including the blood collection adapter 135 and luer lock access device 137 as shown in
[0049] Referring now to
[0050] Next, referring to
[0051] PIVC 200 also includes a side port member 230. However, unlike side port member 130 of PIVC 100, side port member 230 has only a single fluid pathway comprising a branch 233. The branch 233 is coupled to the side inlet 112 of catheter adapter 110 via intermediate tubing 113. However, in some embodiments, it is to be understood that branch 233 may be coupled directly to side inlet 112, thereby obviating the need for intermediate tubing 113.
[0052] In one embodiment, branch 233 of side port member 230 incorporates a connector portion 234 configured as, e.g., a needle-free connector such as the SMARTSITE™ needle-free connector from Becton Dickinson & Company. However, it is to be understood that connector portion 234 may be any appropriate needle-free connector. The connector portion 234 is configured for direct coupling to a variety of devices utilized in blood draw via the PIVC 200. For example, as shown in
[0053] Furthermore, in addition to accommodating blood draw at the time of catheter insertion, the connector portion 234 also allows for coupling to a device such as, e.g., a PIVO™ needle-less blood draw device for blood draw via the indwelling catheter at any time after catheter insertion. That is, the connector portion 234 of side port member 230 allows for the selective coupling and removal of various blood draw devices, including the blood collection adapter 235 and luer lock access device 237 as shown in
[0054] Referring still to
[0055] Next, referring to
[0056] PIVC 300 also includes a side port member 330. The side port member 330 has two fluid pathways comprising a main branch 333 and a side branch 331. The main branch 333 is coupled to the side inlet 112 of catheter adapter 110 via intermediate tubing 113. However, in some embodiments, it is to be understood that main branch 333 may be coupled directly to side inlet 112, thereby obviating the need for intermediate tubing 113.
[0057] The side branch 331 is configured couple an extension set 140 with the side port member 330. As depicted, extension set 140 includes extension tubing 141 that extends between side branch 131 and an access port 143, and may include a pinch clamp 142 for occluding extension tubing 141. It is noted, however, that many different types and configurations of extension sets could be used. In this way, extension set 140 provides a means of fluid infusion via the PIVC 300.
[0058] Unlike side branch 331, main branch 333 of side port member 330 is not coupled to elongated extension tubing. Rather, main branch 333 incorporates a connector portion 334 configured as, e.g., a needle-free connector such as the SMARTSITE™ needle-free connector from Becton Dickinson & Company. However, it is to be understood that connector portion 334 may be any appropriate needle-free connector, a PRN connector, etc.
[0059] Referring still to
[0060] In some embodiments, the adapter 335 includes a distal end coupled to the connector portion 334 and a proximal end configured to couple to a blood collection device (not shown) via an extension tube 336 and access port 337. The adapter 335 includes a fluid pathway disposed between the distal end and the proximal end thereof, with the fluid pathway having a non-linear portion. Blood cells may experience shear stress as they flow through the fluid pathway of adapter 335. The maximum shear stress is along the wall of the blood cell, or wall shear stress. Wall shear stress on blood cells is considered a major source of mechanical damage to blood cells. In some embodiments, the non-linear portion of adapter 335 may facilitate increased flow resistance within the PIVC 300 to distribute the pressure differential and reduce shear stress experienced by red blood cells.
[0061] In some embodiments, the non-linear portion of adapter 335 may form a coil (or spiral) shape, an S-shape, or another suitable non-linear shape. Furthermore, in some embodiments, the non-linear portion may increase a length of the fluid pathway through the adapter 335, and thereby may increase flow resistance and decrease blood flow within the adapter 335. In these embodiments, a risk of hemolysis during blood collection may be reduced.
[0062] In some embodiments, the fluidic resistance may be provided through carefully selecting the length and diameter of the extension tube 336. The increased flow resistance would decrease the blood flow rate within the entire fluid path through the PIVC 300. In these embodiments, a risk of hemolysis during blood collection may be reduced.
[0063] The adapter 335, together with extension tube 336 and access port 337, may be removably coupled to the connector portion 334, with any appropriate blood collection device being couplable to access port 337 to allow for quick blood draw at the time of catheter placement. Furthermore, in addition to accommodating blood draw at the time of catheter insertion via the removable adapter 335, the connector portion 334 also allows for coupling to a device such as, e.g., a PIVO™ needle-less blood draw device for blood draw via the indwelling catheter at any time after catheter insertion. In the case of a PIVO™ needle-less blood draw device, which utilizes a flexible, internal flow tube configured to advance through the PIVC 300 and beyond the tip of catheter 111, the connection of the branch 333 of side port member 230 to the side inlet 112 of catheter adapter 110 via a short length of intermediate tubing 113 allows for effective passage the flexible, internal flow tube through the catheter 111.
[0064] Referring now to
[0065] PIVC 400 also includes a side port member 430. The side port member 430 has two fluid pathways comprising a main branch 433 and a side branch 431. The main branch 433 is coupled to the side inlet 112 of catheter adapter 110 via intermediate tubing 113. However, in some embodiments, it is to be understood that main branch 433 may be coupled directly to side inlet 112, thereby obviating the need for intermediate tubing 113.
[0066] The side branch 431 is configured couple an extension set 140 with the side port member 430. As depicted, extension set 140 includes extension tubing 141 that extends between side branch 131 and an access port 143, and may include a pinch clamp 142 for occluding extension tubing 141. It is noted, however, that many different types and configurations of extension sets could be used. In this way, extension set 140 provides a means of fluid infusion via the PIVC 400.
[0067] Unlike side branch 431, main branch 433 of side port member 430 is not coupled to elongated extension tubing. Instead, main branch 433 incorporates a connector portion 434 configured as, e.g., a needle-free connector such as the SMARTSITE™ needle-free connector from Becton Dickinson & Company. However, it is to be understood that connector portion 434 may be any appropriate needle-free connector, a PRN connector, etc.
[0068] Connector portion 434 is configured for direct coupling to a variety of devices utilized in blood draw via the PIVC 400. Similar to PIVC 300 described above with respect to
[0069] In some embodiments, the blood collection device 438 may include a needle assembly 437, which may include a needle configured to receive a blood collection container. In these and other embodiments, the blood collection container may include an evacuated blood collection tube. In some embodiments, the blood collection container may have all or a portion of air removed so pressure within the blood collection container is lower than ambient pressure.
[0070] In some embodiments, the blood collection device 438 may include or correspond to a luer lock access device, such as, e.g., the VACUTAINER® LUER-LOK™ Access Device from Becton, Dickinson and Company. Furthermore, in some embodiments, a proximal end of the needle assembly 437 may be enveloped within an elastomeric sheath. The elastomeric sheath may include an open distal end and a closed proximal end. In response to a blood collection container pushing the elastomeric sheath distally, the needle of needle assembly 437 may pierce the elastomeric sheath, and the needle may insert into a cavity of the blood collection container, drawing blood therein.
[0071] Similar to adapter 335 described above with respect to
[0072] Referring now to
[0073] PIVC 500 includes a blood draw adapter 501 and a luer lock access device 502, such as, e.g., the VACUTAINER® LUER-LOK™ Access Device from Becton, Dickinson and Company. The blood draw adapter 501 is configured to be coupled to the catheter adapter 110 in-line with the catheter 111 via tubing 504.
[0074] Additionally, in some embodiments, PIVC 500 may include an access port 506 having an air venting cap 508 located on a first branch and a connector 510 (e.g., a PRN, NAC, integrated connector, etc.), with the access port 506 being coupled to a side port of the catheter adapter 110 via tubing 508. While access port 506 is shown in
[0075] PIVC 500 enables blood draw at the time of placement of the catheter 111, with such blood draw being possible through the blood draw adapter 501 and luer lock access device 502, which are fluidly coupled with the catheter 111 at the time of placement. Conversely, during catheter indwell (i.e., after placement), the blood draw adapter 501 and luer lock access device 502 may be removed, thereby accommodating, e.g., a PIVO™ needle-less blood draw device for blood draw via the indwelling catheter at any time after catheter insertion. While not shown, the needle may be partially retracted within the catheter adapter 110 during catheter indwell.
[0076] Next, referring to
[0077] Like PIVC 500 described above with respect to
[0078] Additionally, in some embodiments, PIVC 600 may include an access port 606 having, e.g., an air venting cap located on a first branch and a connector (e.g., a PRN, NAC, integrated connector, etc.) on a second branch, with the access port 606 being coupled to a side port of the catheter adapter 110 via tubing 604.
[0079] PIVC 600 also enables blood draw at the time of placement of the catheter 111. After insertion of the catheter 111, the elongated needle (not shown) can be removed through the blood draw adapter 601, and the luer lock access device 602 may be coupled to the blood draw adapter 601 to allow for a blood draw at the time of catheter placement.
[0080] It is to be understood that the adapter(s) coupled to the side port member may be pre-attached and/or pre-packaged with the side port member in accordance with some embodiments of the present disclosure. However, in other embodiments, the side port member, adapter(s), and any other related componentry may be provided and/or packaged separately and attached by the end user.
[0081] While several embodiments of PIVCs capable of blood draw both at the time of catheter placement and during catheter indwell were described in the foregoing detailed description, those skilled in the art may make modifications and alterations to these embodiments without departing from the scope and spirit of the invention. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The invention described hereinabove is defined by the appended claims and all changes to the invention that fall within the meaning and the range of equivalency of the claims are embraced within their scope.