1. Technical Field
The present disclosure relates to medical needles having structure to facilitate visualization of flashback. More specifically, the present disclosure relates to vented phlebotomy needles including structure to facilitate visualization of flashback.
2. Background of Related Art
Medical devices are well known for drawing blood from patients. These devices include standard needle-syringes, butterfly needle sets and phlebotomy needles. Typically, a butterfly needle set includes a hollow needle having a sharpened distal end and a proximal end which is secured to a needle hub. A proximal portion of the needle hub is connected to flexible tubing. The needle hub defines a fluid conduit communicating with the tubing and includes a pair of flexible, radially extending wings which facilitate grasping of the butterfly needle set by medical personnel. Generally, the flexible tubing is formed of a transparent material which allows medical personnel to visualize blood flow, i.e, flashback, through the tubing immediately proximal to the needle hub. Visualization of flashback allows medical personnel to confirm that the needle has been properly inserted into a patient.
Some clinicians utilize hypodermic needle-syringes with transparent needle hubs to obtain blood samples. During insertion, those clinicians typically observe flashback in the needle hubs.
Generally, phlebotomy needles have not included structure for visualizing flashback. Although the lack of structure for visualizing flashback in phlebotomy needles is not a major drawback for more experienced medical personnel, for those having little experience drawing blood with phlebotomy needles, the lack of any means to confirm that the needle has been properly positioned within a patient may increase the time required to draw blood and add to the discomfort of a patient.
In an attempt to overcome the above disadvantages, U.S. Pat. No. 5,450,856 to Norris discloses a phlebotomy needle which is attachable to a blood collection tube and includes an outboard needle, an inboard needle and a bulb therebetween. The bulb is clear and allows medical personnel to visualize blood within the bulb when the outboard needle has been properly positioned within the vein of a patient. The bulb also includes a button which can be depressed by medical personnel to vent air from within the needle. Air within the needle prevents blood from flowing through the needle and must be vented.
Although the Norris phlebotomy needle facilitates visualization of flashback, a less expensive, less complex phlebotomy needle which facilitates visualization of flashback is desired.
The present disclosure is directed to a phlebotomy needle which includes a distal needle portion having a sharpened distal end configured to pierce tissue, a proximal needle portion having a sharpened proximal end configured to pierce a stopper of a blood collection tube, and a central needle portion defining an opening. The distal needle portion, the proximal needle portion and the central needle portion define a fluid channel which communicates with the opening. A material is positioned adjacent the opening. The material is of a type to permit passage of air through the opening to exit the fluid channel while preventing passage of blood. In one embodiment, the material provides a visual indication of blood flow adjacent the opening, i.e., flashback.
In one embodiment, the material includes a hydrophobic material. In an alternate embodiment, the material includes a hydrophilic wicking material. In yet another embodiment, the material includes a hydrophobic plug. Alternately, the material can define a collar positioned about the opening.
In one embodiment, the opening is circular. Alternately, it is envisioned that the opening can assume a variety of configurations, e.g., rectangular or slot-shaped.
In one embodiment, a transparent housing is positioned about the opening to facilitate visualization of flashback. The housing can also be positioned to encompass the material and can include a vent for venting air from the needle.
In one embodiment, the phlebotomy needle includes engagement structure which is configured to engage a needle holder.
In one embodiment, a check valve is provided to inhibit passage of air through the opening into the fluid channel. In yet another embodiment, the phlebotomy needle includes a needle holder.
Embodiments of the presently disclosed vented phlebotomy needle with flashback chamber are disclosed herein with reference to the drawings, wherein:
Embodiments of the presently disclosed vented phlebotomy needle with flashback chamber will now be described in detail with reference to the drawings wherein like reference numerals designate identical or corresponding elements in each of the several views.
Needle holder 12 includes a substantially cylindrical body 30 having a distal end including engagement member 26 and a proximal end including a pair of flange members 32. Flange members 32 facilitate gripping and insertion of a blood collection tube 17 by medical personnel. Cylindrical body 30 defines a cavity 34 (
As shown in
Referring to
Referring to
Transparent housing 112 allows a medical practitioner to visualize the flow of blood through needle 100 when distal end 102 of needle 100 has been properly positioned within the vein of a patient, i.e., as blood flows through needle 100, air will be vented and blood will flow through opening 110 into reservoir 112a. This allows the medical practitioner to confirm that the distal end 102 of needle 100 has been properly positioned within a patient's vein to draw blood. This provides a great benefit to medical practitioners attempting to draw blood from a patient, especially those practitioners having a limited amount of experience drawing blood from a patient with a phlebotomy needle.
In an alternate embodiment also shown in
Although only hydrophilic and hydrophobic materials have been discussed herein, other materials which facilitate passage of air while preventing passage of blood and which provide an indication of blood flow can be used with the presently disclosed phlebotomy needle. The material can have other configurations not disclosed herein, e.g., the material may define a pad which covers the opening.
A stepped housing 408 has a distal portion 408a and a larger-diameter proximal portion 408b. Stepped housing 408 is supported on central portion 406. Distal portion 408a defines a throughbore 412 dimensioned to receive needle central portion 406. Distal portion 408a is sealingly secured to needle 400 using, for example, an adhesive 410. Alternately, other known techniques can be used to secure needle 400 to housing 408, e.g., crimping, clamps, screws, welding etc. Proximal portion 408b is formed of a transparent or translucent material to facilitate visualization within proximal portion 408b of housing 408. Proximal portion 408b also defines throughbore 414 which communicates with the throughbore 412 but is larger in diameter than throughbore 412. Proximal portion 408b defines an annular recess 416 between portion 408b and proximal end 404 of needle 400. Recess 416 is dimensioned to receive a hydrophilic material 418 and an inner fluted member 420. Inner fluted member 420 is positioned about proximal end 404 of needle 400 and defines a plurality of channels 422 which communicate with hydrophilic material 418. A vent opening 409 is provided through housing 408.
An elastomeric shield 428 is positioned over proximal end 404 of needle 400. As discussed above, elastomeric shield 428 is resilient and functions to seal proximal end 404 of needle 400 when proximal end 404 of needle 400 is not connected to a blood collection tube (not shown). Elastomeric shield 428 includes a closed proximal end 428a and an open distal end 428b. Open distal end 428b includes an annular flange 430 which is positioned adjacent material 418 within recess 416 of housing 408. Proximal portion 408b of housing 408 includes an inwardly extending annular rib 432 which is positioned to engage flange 430 of elastomeric shield 428 to retain distal end 428b of shield 428 within recess 416 of housing 408. As illustrated by arrows 434, a flow path 436 is defined between elastomeric shield 428 and proximal end 404 of needle 400. Flow path 436 directs blood from proximal end 404 of needle 400 into fluted channels 422 of fluted member 420 into contact with hydrophilic material 418. In use, when blood contacts material 418, material 418 provides a visual indication of blood flow which is visible through proximal portion 408b of housing 408.
The vent openings 113 defined in connection with filter 116,
It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
This application claims priority from U.S. provisional application Ser. No. 60/877,937, filed Dec. 29, 2006, the entirety of which is incorporated herein by reference.
Number | Date | Country | |
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60877937 | Dec 2006 | US |