Blood Collection Device for Small Volume Sample Acquisition Through Peripheral Intravenous Catheters
20230277104 · 2023-09-07
Inventors
- Erica E. Neumann (Sandy, UT, US)
- John M. Lackey (West Valley City, UT, US)
- Benjamin P. Hopwood (Salt Lake City, UT, US)
- Jonathan Karl Burkholz (Salt Lake City, UT, US)
- Weston F. Harding (Lehi, UT)
- Shaun Lauer (Portland, OR, US)
Cpc classification
A61B5/150572
HUMAN NECESSITIES
A61B5/153
HUMAN NECESSITIES
A61M5/31513
HUMAN NECESSITIES
A61B5/150732
HUMAN NECESSITIES
A61B5/1545
HUMAN NECESSITIES
A61B5/150236
HUMAN NECESSITIES
A61B5/150992
HUMAN NECESSITIES
A61B5/150389
HUMAN NECESSITIES
A61B5/15074
HUMAN NECESSITIES
A61M25/0017
HUMAN NECESSITIES
A61B5/150755
HUMAN NECESSITIES
A61B5/150473
HUMAN NECESSITIES
A61B5/150259
HUMAN NECESSITIES
A61B5/150351
HUMAN NECESSITIES
International classification
A61M5/315
HUMAN NECESSITIES
Abstract
Provided herein is a blood collection device having a tube having a proximal end, a distal end, and a sidewall therebetween defining an interior, the interior configured to receive a blood sample through one or more openings at the distal end of the tube when the distal end of the tube is positioned in a blood vessel and an obturator slidably disposed relative to the tube and received within the interior of the tube.
Claims
1. A blood collection device comprising: a tube having a proximal end, a distal end, and a sidewall therebetween defining an interior, the interior configured to receive a blood sample through one or more openings at the distal end of the tube when the distal end of the tube is positioned in a blood vessel; and an obturator slidably disposed relative to the tube and received within the interior of the tube.
2. The blood collection device of claim 1, wherein the obturator is slidable relative to the tube between a retracted position, in which the obturator blocks the one or more openings at the distal end of the tube, and an extended position in which the one or more openings at the distal end of the tube are not blocked.
3. The blood collection device of claim 1, wherein the obturator is slidable relative to the tube between an extended position, in which the one or more openings at the distal end of the tube are not blocked, and an extended position in which the obturator blocks the one or more openings at the distal end of the tube.
4. The blood collection device of claim 1, wherein the obturator comprises a support wire.
5. The blood collection device of claim 1, further comprising a vent plug arranged within the tube interior, configured to allow air to pass therethrough.
6. The blood collection device of claim 1, wherein the obturator comprises a tip configured to prevent sample contamination within the interior of the tube.
7. The blood collection device of claim 1, wherein the tube comprises an opening at the proximal end, and wherein the obturator is configured to expel blood from the interior of the tube through the opening at the proximal end of the tube.
8. The blood collection device of claim 1, wherein the tube comprises a coil arranged at the distal end thereof.
9. A blood collection device comprising: an outer tube having a proximal end, a distal end, and a sidewall therebetween defining an interior configured to receive a blood sample when the distal end of the tube is positioned in a blood vessel; and an inner tube, received within the interior of the outer tube, and slidably and/or rotatably disposed relative to the outer tube, the inner tube comprising a proximal end, a distal end, and a sidewall therebetween, wherein the inner tube comprises one or more openings at the distal end thereof.
10. The blood collection device of claim 9, wherein the inner tube is slidable relative to the outer tube between a retracted position, in which the outer tube blocks the one or more openings at the distal end of the inner tube, and an extended position in which the one or more openings at the distal end of the inner tube are not blocked.
11. The blood collection device of claim 9, wherein the outer tube comprises one or more openings at the distal end thereof, and wherein the inner tube is rotatable relative to the outer tube between a first position, in which the one or more openings at the distal end of the outer tube are not aligned with the one or more openings at the distal end of the inner tube, and a second position in which the one or more openings at the distal end of the outer tube are aligned with the one or more opening at the distal end of the inner tube, thereby allowing blood to flow into the interior of the outer tube.
12. The blood collection device of claim 9, further comprising a vent plug arranged within the tube interior, configured to allow air to pass therethrough.
13. The blood collection device of claim 9, wherein the inner tube comprises a tip configured to prevent sample contamination within the interior of the tube.
14. The blood collection device of claim 9, wherein the outer tube and/or the inner tube comprises a coil arranged at the distal end thereof.
15. A blood collection device comprising: a syringe barrel having a proximal end, a distal end, and a sidewall therebetween defining an interior configured to receive a blood sample; a collection tube slidably received within the syringe barrel interior, the collection tube comprising a proximal end, a distal end having one or more openings therein, and a sidewall therebetween defining a collection tube interior in fluid communication with the interior of the syringe barrel and configured to receive blood therein when the distal end of the collection tube is positioned in a blood vessel; a tube plunger comprising a proximal end, a distal end, and a sidewall therebetween, the tube plunger being slidably received within the interior of the syringe barrel and coupled with the collection tube; and a sample plunger slidably received within the interior of the syringe barrel and configured to draw blood into the collection tube interior through the distal end of the collection tube.
16. The blood collection device of claim 15, wherein the proximal end of the syringe is configured to reversibly couple to an indwelling catheter.
17. The blood collection device of claim 15, wherein the proximal end of the syringe barrel comprises a luer connection.
18. The blood collection device of claim 15, wherein the tube plunger is coupled to the proximal end of the collection tube.
19. The blood collection tube of claim 15, wherein the collection tube and tube plunger are configured such that displacement of the tube plunger in a distal direction displaces the collection tube distally a corresponding distance.
20. The blood collection tube of claim 15, wherein the sample plunger is slidably received within the tube plunger interior.
21. The blood collection device of claim 15, wherein the sample plunger is configured such that displacement of the sample plunger in a proximal direction causes blood to be drawn through the collection tube into the syringe barrel interior.
22. The blood collection device of claim 15, wherein the collection tube comprises a plurality of openings at the distal end thereof.
23. The blood collection device of claim 15, further comprising a septum at the distal end of the syringe barrel.
24. The blood collection device of claim 15, wherein the tube plunger comprises one or more air vents at the distal end thereof.
25. The blood collection device of claim 15, wherein the collection tube comprises a coil arranged at the distal end thereof.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DESCRIPTION OF THE INVENTION
[0044] The following description is provided to enable those skilled in the art to make and use the described embodiments 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 invention.
[0045] For 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 drawing figures. 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 embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.
[0046] It should be understood that any numerical range recited herein is intended to include all values and sub-ranges subsumed therein. For example, a range of “1 to 10” is intended to include all sub-ranges between (and including) the recited minimum value of 1 and the recited maximum value of 10, that is, having a minimum value equal to or greater than 1 and a maximum value of equal to or less than 10.
[0047] Referring now to
[0048] In some non-limiting embodiments or aspects, the first catheter assembly 10 may include a first catheter 22 extending from the distal end 14. In some embodiments, the first catheter 22 may include a peripheral intravenous catheter, a midline catheter, or a peripherally-inserted central catheter. Catheter 22 may be formed of any suitable material and may be of any useful length, as known to those of skill in the art. In some non-limiting embodiments or aspects, the first catheter assembly 10 may include a first fluid conduit 24 extending from the side port 18. First fluid conduit 24 may be formed of any suitable material known to those of skill in the art, and may have a distal end 26 and a proximal end 28, and first fluid conduit 24 may be coupled, at distal end 26 thereof, to side port 18. In some non-limiting embodiments or aspects, a connector 30 may be coupled to a proximal end 28 of first fluid conduit 24. Connector 30 may be a t-connector (e.g., one side port arranged at a 90 degree angle relative to a longitudinal axis of connector 30), a y-connector (e.g., one side port arranged at a 25, 60, or 75 degree angle relative to a longitudinal axis of connector 30), or any other type of connector known in the art, and may include a second lumen therethrough, having any number of branches suitable for the type of connector.
[0049] In some non-limiting embodiments or aspects, catheter assembly 10 may include an extension set including a second fluid conduit 34. In non-limiting embodiments, connector 30 includes a side port to which an extension set (e.g., second fluid conduit 34) may be connected. Extension sets are known to those of skill in the art and are commercially available from, for example, Becton, Dickinson and Company under the tradenames MAXPLUS, MAXZERO, NEUTRACLEAR, Q-SYTE, and SMARTSITE. In some non-limiting embodiments or aspects, second fluid conduit 34 may include a luer connection 36 at an end thereof. In some non-limiting embodiments or aspects, the extension set may include a clamp 40, to allow for occlusion of second fluid conduit 34. Clamp 40 and second fluid conduit 34 may be formed of any suitable materials known to those of skill in the art. In non-limiting embodiments, second lumen 31 has an inner diameter that is substantially equivalent to an inner diameter of first fluid conduit 24 and/or second fluid conduit 34.
[0050] Catheter assembly 10 may include a needleless access connector 32 and/or a second fluid conduit 34. Needleless access connectors are known to those of skill in the art and are commercially available from, for example, Becton, Dickinson and Company under the tradenames SMARTSITE and Q-SYTE.
[0051] Blood collection devices and systems as described herein, and as exemplified in
[0052] Blood collection device 100 further includes an obturator 140. Obturator 140 may include a proximal end, a distal end, a tip 142 at the distal end, and a support wire 144 to assist in sliding obturator 140 relative to collection tube 110. Tip 142 of obturator 140 may be configured to aid in traversing blockages in a blood vessel into which blood collection device 100 is positioned, such as clots, thrombi, or the like. Tip 142 may also be configured, for example by the inclusion of one or more sealing members, to prevent contamination, for example to prevent contamination of a sample as blood collection device 100 is positioned within a blood vessel and a sample is obtained, as described below. Once positioned within a blood vessel, obturator 140 may be extended (
[0053] In non-limiting embodiments, collection tube 110 may include a vent plug 120, configured to allow air to be displaced out of interior 118, which may aid in causing blood to flow into interior 118, and/or pulling blood into interior 118, for example through application of a vacuum due to displacement of air out of interior 118. In non-limiting embodiments, vent plug 120 is liquid impermeable, such that blood cannot flow proximally out of collection tube 110. In this way, obturator 140 can be withdrawn, or extended, to provide a seal at distal end 114 of collection tube 110, allowing for removal of blood collection device 100 from the blood vessel, with a sample held in interior 118.
[0054] In non-limiting embodiments, blood collection device 100 is configured to expel the blood sample from the distal end 114 thereof. For example, a medical professional utilizing device 100 to withdraw a small-volume sample from an indwelling catheter, such as a PIVC, can then use obturator 140 as a plunger, similar to that of a standard syringe, to expel blood from the distal end 114 of collection tube 110. In this way, a liquid impermeable vent plug 120 may act as a stopper as typically included in standard syringes.
[0055] Turning to
[0056] In non-limiting embodiments, inner tube 240 and outer tube 210 may be slidable and/or rotatable relative to one another. In non-limiting embodiments, inner tube 240 is slidable relative to outer tube 210, such that when distal end 214 of outer tube is positioned in a blood vessel, inner tube 240 may be extended distally. In this way, the one or more openings 246 in inner tube 240 place interior 218 of outer tube 210 in fluid communication with the blood vessel, allowing blood to enter the interior 218.
[0057] In non-limiting embodiments, inner tube 240 may be rotatable relative to outer tube 210, and outer tube 210 may include one or more openings at or near distal end 214 thereof. Inner tube 240 may be rotatable between a first position, where one or more openings do not align with one or more openings in outer tube 210, thus blood is blocked from flowing into interior 218, to a second position, where one or more of openings 246 in inner tube 240 are aligned with one or more openings in outer tube 210, thereby placing interior 218 in fluid communication with the blood vessel, allowing blood to enter the interior 218.
[0058] Turning to
[0059] Collection tube 340 may be slidable relative to syringe barrel 310 between a retracted position, in which distal end 342 is within syringe barrel 310 or the distal end 314 of the syringe barrel 310, and an extended positon, in which distal end 342 of collection tube 340 extends beyond syringe barrel 310 or distal end 314 of the syringe barrel 310, for example into a blood vessel. Collection tube may include one or more openings 345 at or near distal end 342 thereof, as shown in
[0060] Device 300 further includes a tube plunger 320, received within syringe barrel interior 318. Tube plunger 320 may be coupled to collection tube 340 and slidable relative to syringe barrel 310, the tube plunger 320 having a proximal end 322, distal end 324, and sidewall 325 therebetween defining an interior 326. Tube plunger 320 may have one or more vents 321 arranged at or near distal end 324 thereof (
[0061] Device 300 may be utilized to collect small volume blood samples. When distal end 314 of syringe barrel 310 is connected to a catheter, such as one or more components of catheter assembly 10 shown in
[0062] With reference to
[0063] A blood stabilization device may be reversibly coupled to a vascular access device 450, such that a collection tube 420 carried by vascular access device 450 and is slidable relative thereto can be advanced into a blood vessel, for example by a user advancing tab 421 distally. As shown in
[0064] In non-limiting embodiments, device 400 includes one or more blood stabilization chemicals. Blood stabilization chemicals may be coated onto an interior surface of sidewall 415. In non-limiting embodiments, device 400 includes a porous substrate 418, such as an open-cell foam, arranged at or near distal end 414 of housing 410, into and/or onto which one or more blood stabilization chemicals are adhered and/or embedded, such that as a blood sample enters housing interior 422, it flows through the substrate, and the one or more chemicals are then mixed with the blood sample. In non-limiting embodiments, the one or more blood stabilization chemicals are dispersed within the cells of the open cell foam to promote the effectiveness of the flow-through mixing and blood stabilization chemical uptake. In non-limiting embodiments, the open cell foam may be a soft deformable open cell foam that is inert to blood, for example, a melamine foam, such as BASOTECT foam commercially available from BASF (Ludwigshafen, Germany), or may be formed of a formaldehyde-melamine-sodium bisulfite copolymer. The open cell foam may also be a flexible, hydrophilic open cell foam that is substantially resistant to heat and organic solvents. In one embodiment, the foam may include a sponge material. The one or more blood stabilization chemicals may be introduced into the open cell foam by soaking the foam in a liquid solution of the one or more blood stabilization chemicals and water, and subsequently evaporating the water, forming a dry additive powder finely distributed throughout the internal structure of the foam.
[0065] In non-limiting embodiments, for example as shown in
[0066] In non-limiting embodiments, one or more beads, coated and/or impregnated with one or more blood stabilization chemicals, can be included in housing interior 422, and can be mixed with a blood sample received therein. Suitable stabilization chemicals are known to those of skill in the art, and can include one or more of heparin, ethylenediaminetetraacetic acid (EDTA), and/or a citrate, such as sodium citrate.
[0067] With reference to
[0068] Although the present disclosure has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is solely for that purpose and that the present disclosure is not limited to the disclosed embodiments or aspects, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.