US20090156963A1 - Blood Collection Device with Tube Retaining Structure - Google Patents

Abstract

A blood collection device is disclosed which includes a body defining a receptacle dimensioned to receive a blood collection tube. The body has a first open end and a second end supporting a needle having a proximal end extending into the receptacle and a distal end extending distally of the body. Retaining structure is supported on the body. The retaining structure extends into the receptacle and is configured to releasably retain the blood collection tube within the receptacle.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• The present application claims the benefit of and priority to U.S. Provisional Patent Application No. 61/007,639, filed on Dec. 14, 2007, which is incorporated herein by reference in its entirety.
BACKGROUND
• 1. Technical Field
• The present disclosure relates to the field of medical fluid transfer devices and, more particularly, to devices for safely transferring bodily fluids to a receptacle.
• 2. Description of Related Art
• In the medical field, fluid transfer devices, particularly, blood collection devices are used to draw blood from patients for blood tests and other medical procedures. At all times, phlebotomists have to be careful of the being exposed to life-threatening bloodborne pathogens (BBP) such as HIV and hepatitis.
• Blood collection devices are well known in the medical field and typically include a body defining a receptacle which is dimensioned to receive a blood collection tube. The body includes an open proximal end and a distal end, which supports a needle. The needle has a distal end extending from the distal end of the body and a proximal end extending into the receptacle. The proximal end of the needle positioned within the receptacle is covered by a flexible valve member which is provided to reseal the proximal end of the needle after a blood collection tube has been removed from the receptacle.
• In use during a blood draw procedure, a phlebotomist will insert the distal end of the needle into a patient's vein. Thereafter, the phlebotomist will insert a blood collection tube into the receptacle of the blood collection device. Generally, the blood collection tube includes a pierceable septum such that when the tube is inserted into the receptacle, the proximal end of the needle will engage the septum and pierce both the valve member and the septum. As the tube is pressed into the receptacle, the valve member is compressed distally about the needle.
• The valve member is formed from a resilient material, which will return to a position to seal the proximal end of the needle when the blood collection tube is removed from the receptacle. When the valve member is in a compressed state, the valve member tends to urge the blood collection tube from the receptacle of the blood collection device, which results in slowing or stopping the blood flow into the blood collection tube. To prevent or ensure that a blood collection tube is not pushed from the valve member, medical personnel may have to grip the blood collection tube while holding the blood collection device in position. If a blood collection tube were to become disengaged from a blood collection device, it is likely that the tube would break and blood would be spilled exposing medical personnel to the dangers of BBP's and also broken glass.
• Accordingly, it would be useful and beneficial, in the art of medical devices, for an inexpensive, simple device capable of securing and holding a blood collection tube, or the like, within the receptacle of a blood collection device.
SUMMARY
• A blood collection device is disclosed which includes a body defining a receptacle dimensioned to receive a blood collection tube. The body has a first open end and a second end supporting a needle having a proximal end extending into the receptacle and a distal end extending distally of the body. Retaining structure is supported on the body. The retaining structure extends into the receptacle and is configured to releasably retain the blood collection tube within the receptacle. In one embodiment, the retaining structure is integrally formed with the body defining the receptacle and includes at least one arm pivotally supported on the body and configured to engage a blood collection tube positioned within the receptacle. The at least one arm may include a pair of spaced arms. In one embodiment, each of the at least one arms includes a surface positioned to engage a blood collection tube which is slip-resistant. The slip-resistant surface may be textured, e.g., ratchet teeth, granules, serrations, knurling, etc. Alternately, the slip-resistant surface may include an elastomeric layer of material.
• In one embodiment, the retaining structure includes at least one finger nub. Each of the at least one finger nubs is connected to one of the at least one arms by a pivot member and is actuable to disengage the at least one arm from engagement with a blood collection tube positioned within the receptacle of the body. The retaining structure may include one or more teeth which are configured to engage the blood collection tube.
• In one embodiment, the retaining structure is supported on an inner surface of the body defining the receptacle. The retaining structure may include at least one resilient biasing member disposed on an inner surface of the body. The at least one resilient biasing member has first and second ends secured to the inner surface of the body such that a central portion of the at least one resilient biasing member bows inwardly from the inner surface of the body into the receptacle.
BRIEF DESCRIPTION OF THE DRAWINGS
• Various embodiments of the presently disclosed medical access device are disclosed herein with reference to the drawings, wherein:
• FIG. 1 is a perspective view of one embodiment of the presently disclosed blood collection device;
• FIG. 2 is a perspective view of the blood collection device shown inFIG. 1 with a blood collection tube inserted therein;
• FIG. 3 is a side cross-sectional view of the blood collection device shown inFIG. 1 taken along section lines3-3;
• FIG. 4 is a side cross-sectional view of the blood collection device shown inFIG. 2 with the blood collection tube inserted therein;
• FIG. 5 is a side cross-sectional view of the blood collection device shown inFIG. 2 as the blood collection tube is removed therefrom;
• FIG. 6 is a side cross-sectional view of another embodiment of the presently disclosed blood collection device;
• FIG. 7 is a side cross-sectional view of the blood collection device shown inFIG. 6 with a blood collection tube inserted therein;
• FIG. 8 is a perspective view of another embodiment of the presently disclosed blood collection device with a blood collection tube inserted therein;
• FIG. 9 is a side cross-sectional view of the blood collection device shown inFIG. 8 with the blood collection tube removed;
• FIG. 10 is a side cross-sectional view of the blood collection device shown inFIG. 8 with the blood collection tube inserted therein;
• FIG. 11 is a side cross-sectional view of yet another embodiment of the presently disclosed blood collection device; and
• FIG. 12 is a side cross-sectional view of the blood collection device shown inFIG. 11 with a blood collection tube inserted therein.
DETAILED DESCRIPTION
• Embodiments of the presently disclosed medical device 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. In the discussion that follows, the term “proximal” refers to a portion of a structure that is closer to a user, and the term “distal” refers to a portion that is further from the user.
• Referring initially toFIGS. 1-5, a medical blood collector is provided, which includes ablood collection device10 having a substantiallytubular housing2 defining areceptacle11.Housing2 includes a proximal open end4 and adistal end6 having ahub14 disposed thereon. Afinger flange12 is provided on the proximal end4 ofhousing2 to facilitate insertion of ablood collection tube30 intoreceptacle11. Proximal open end4 is configured and dimensioned to allow ablood collection tube30 to be inserted therethrough.
• Hub14 defines a channel (not shown) for receiving and securing atransfer needle34 andpatient needle16 to housing2 ofblood collection device10.Transfer needle34 extends proximally fromhub14 intoreceptacle11.Patient needle16 extends distally fromhub14 to a location distally ofhousing2. In one embodiment,transfer needle34 andpatient needle16 are manufactured in a one-piece configuration as a double-ended needle. Alternatively, transferneedle34 andpatient needle16 may be manufactured in a multiple-piece construction and maintained in fluid communication with each other throughhub14. It is also contemplated thattransfer needle34 andpatient needle16 or the one-piece needle equivalent may be secured to a needle hub which is received by and attached tohub14.
• Aresealable valve member36 is positioned overtransfer needle34 to sealtransfer needle34 when ablood collection tube30 is not positioned withinreceptacle11.Resealable valve member36 is formed from a resilient, pierceable material.
• Patient needle16 is configured to pierce through a patient's blood vessel to perform a blood draw procedure.Transfer needle34 andpatient needle16 are in fluid communication to allow blood flow from the patient's blood vessel to transferneedle34. Whenblood collection tube30 is longitudinally inserted into proximal end4 ofhousing2 towards distalclosed end6 ofhousing2,transfer needle34, which has a sharpenedproximal end34a, pierces apierceable septum32 ofblood collection tube30 to allow blood to flow fromtransfer needle34 intoblood collection tube30.
• Referring also toFIGS. 3-5,blood collection device10 includes retainingstructure20. Embodiments of the presently disclosedblood collection device10 include one or more substantially identical retaining structures. For purposes of brevity, only one retaining structure will be explained in detail.
• Retainingstructure20 is configured and dimensioned to releasably retain ablood collection tube30 withinreceptacle11 ofblood collection device10. Retainingstructure20 includes a retainingarm22 and a finger actuation member ornub24, which are integrally formed withreceptacle11. Retainingarm22 andfinger nub24 are pivotably connected at apivot member26, which is also integrally formed withreceptacle11. Retainingarm22 includes aninner surface28 which defines a portion of a wall ofreceptacle11 and is configured to retainblood collection tube30 withinreceptacle11.Inner surface28 of retainingarm22 may be constructed from any type of suitable gripping surface, e.g., ratchet teeth, elastomeric material, granular material, etc., suitable to retain and/or engage ablood collection tube30.
• As depicted inFIGS. 3-5, one ormore ratchet teeth28aare disposed oninner surface28 of retainingarm22 and are configured to allow substantially non-resistive movement in the insertion direction, but prevent movement in the removal direction. Ratchetteeth28amay have a different slope on proximal and distal sides of each tooth to effect this result. Retainingarm22 is configured to be biased in an inward direction towards longitudinal axis “A” ofreceptacle11 such that ratchetteeth28aengageblood collection tube30 to retaintube30 within receptacle11 (FIG. 4).Arms22 may be biased inwardly due to the natural resilience of the material used to constructarms22, e.g., plastic, or alternatively, a biasing member, e.g., spring steel, may be secured toarms22 to provide a biasing force. When medical personnel desire to removetube30 fromreceptacle11,finger nub24 can be pressed inwardly to pivot retainingarm22 aboutpivot member26 outwardly out of engagement with tube30 (FIG. 5).
• In summary, asblood collection tube30 is inserted intoreceptacle11 ofdevice10,transfer needle34 piercesvalve member36 andpierceable septum32 ofblood collection tube30. Asblood collection tube30 is longitudinally moved towardsdistal end6 ofreceptacle11,valve member36 compresses and creates a biasing effect, thus urgingblood collection tube30 out ofreceptacle11. Ratchetteeth28aof retainingstructure20 are dimensioned and configured to engage and retainblood collection tube30 withinreceptacle11 ofdevice10.
• As mentioned above,blood collection tube30 is removed fromreceptacle11, as shown inFIG. 5, by pushingfinger nub24 inwards towards the longitudinal axis ofdevice10. When this occurs, retainingarm22 is pivoted about livinghinge26 to pivot retainingarm22 outwardly to disengage ratchetteeth28afromblood collection tube30. As this occurs, the user can pull on theblood collection tube30 to removetube30 fromreceptacle11.
• FIGS. 6 and 7 illustrate another embodiment of the presently disclosed blood collection device shown generally as100.Blood collection device100 defines areceptacle111 and includes atransfer needle134 and avalve member136, which function in the same manner as the like elements described above.Collection device100 also includes a patient needle (not shown) which can be fixedly secured todevice100, removably secured todevice100 using, for example, a luer type connector, or otherwise attached todevice100 in combination withtransfer needle134 as described previously. Retainingstructure120 includes a biasingmember122 disposed oninner surface113 ofreceptacle111.Biasing member122 may be composed of a resilient metal strip, or any suitable biasing material known in the art.Biasing member122 includes afirst end124 and asecond end126. First and second ends,124 and126, respectively, are secured to aside wall113 ofreceptacle111 such that a central portion ofmember122 bows intoreceptacle111. It is also contemplated that biasingmember122 may be secured toside wall113 by onlyfirst end124 orsecond end126 of biasingmember122.
• In use, as shown inFIG. 7,blood collection tube130 is inserted longitudinally intoreceptacle111. Biasingmembers122 of retainingstructure120 are configured to provide a smaller diameter to engage and retaintube130 withinreceptacle111. A tube engaging surface of retainingstructure120 may comprise a textured surface (e.g., serrated, granular, tacky, etc.) to more securely engagetube130 and prevent slippage oftube130 in relation to biasingmembers122. Retainingstructure120 may also be configured and adapted to retain different shapes and sizes of blood collection tubes withinreceptacle111, i.e., retainingmembers122 may be dimensioned and configured to retain tubes having a variety of different shapes withinreceptacle111 ofdevice100.
• As shown inFIGS. 8-10, in another embodiment ofblood collection device200retaining structure220 defines one or more resilient bump-like raised inner wall portions222 (i.e., one, two, three, four, etc.) alongsideinner wall224 ofdevice200. Retainingstructure220 provides a smaller inner diameter ofreceptacle211 to secure ablood collection tube230 withinreceptacle211. The wall thickness of raisedwall222 may be thinner than surroundinginner wall224 to facilitate engagement withblood tube230. The raisedwall222 may be formed during a forming process (e.g., an injection molding process or a deformation process) and/or by a forming device.
• In one embodiment, the forming device may be a heating element (not shown) that is configured to heat theoutside wall226 ofreceptacle211 to form indentations inoutside wall226 ofreceptacle211 and thus, form raised-wall222 along the internal wall ofdevice200. In other embodiments, the forming device may be a roller-type element (not shown) having, for example, a star-shaped element. Alternatively, the forming device may be a collet (not shown) with forming detents on an inner diameter of the collet.
• FIGS. 11 and 12 illustrate another embodiment of the presently disclosed blood collection device shown generally as300.Blood collection device300 includes a tubular shapedbody302 defining areceptacle311 having a proximal anddistal ends304 and306, respectively.Body302 includes a retainingstructure320 having a retainingarm322 and finger member ornub324. Retainingarm322 andfinger nub324 are pivotably connected tobody302 at aliving hinge326, which is located onproximal side304 ofbody302.
• Blood collection tube330 is retained within thereceptacle311 by retainingarms322 of retainingstructure320. Retainingarms322 include an elastomeric coating on aninner surface328 of retainingarms322 positioned to frictionally engageblood collection tube330 located withinreceptacle311. The elastomeric coating oninner surface328 provides a tight, non-slip surface for releasably retainingblood collection tube330 within receptacle311 (FIG. 12). In one embodiment, the elastomeric coating is overmolded ontoarms322. Alternately, other techniques can be used to secure the elastomeric coating to thearms322 of retainingstructure320.
• While several embodiments of the disclosure have been shown in the drawings and/or discussed herein, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Claims (16)

1. A blood collection device comprising:

a body defining a receptacle dimensioned to receive a blood collection tube, the body having a first open end and a second end supporting a needle, the needle having a proximal end extending into the receptacle, and a retaining structure extending into the receptacle configured to releasably retain the blood collection tube within the receptacle.

2. The blood collection device according toclaim 1, wherein the needle further comprises a distal end extending distally of the body.

3. The blood collection device according toclaim 1, wherein the retaining structure is integrally formed with the body defining the receptacle.

4. The blood collection device according toclaim 1, wherein the retaining structure defines one or more teeth which are configured to engage the blood collection tube.

5. The blood collection device according toclaim 1, wherein the retaining structure is supported on an inner surface of the body defining the receptacle.

6. The blood collection device according toclaim 1, wherein the retaining structure includes at least one arm pivotally supported on the body and configured to engage a blood collection tube positioned within the receptacle.

7. The blood collection device according toclaim 6, wherein the at least one arm includes a pair of spaced arms.

8. The blood collection device according toclaim 6, wherein the at least one arm includes a surface positioned to engage a blood collection tube which is slip-resistant.

9. The blood collection device according toclaim 8, wherein the slip-resistant surface is textured.

10. The blood collection device according toclaim 9, wherein the textured surface is selected from the group consisting of ratchet teeth, granules, serrations and knurling.

11. The blood collection device according toclaim 8, wherein the slip-resistant surface includes an elastomeric layer of material.

12. The blood collection device according toclaim 6, wherein the retaining structure includes at least one finger nub, each of the at least one finger nubs being connected to one of the at least one arms by a pivot member, the at least one finger nubs being actuable to disengage the at least one arm from engagement with the blood collection tube positioned within the receptacle of the body.

13. The blood collection device according toclaim 1, wherein the retaining structure includes at least one resilient biasing member disposed on an inner surface of the body, the at least one resilient biasing member having first and second ends, wherein at least one of the first and second ends is secured to the inner surface of the body such that a central portion of the at least one resilient biasing member bows inwardly from the inner surface into the receptacle.

14. A blood collection device comprising:

a body defining a receptacle dimensioned to receive a blood collection tube, the body having a first open end and a second end supporting a needle, the needle having a proximal end extending into the receptacle, and a retaining structure extending into the receptacle configured to releasably retain the blood collection tube within the receptacle, wherein the retaining structure includes a pair of spaced arms, each of the pair of spaced arms being pivotally supported on the body and configured to engage a blood collection tube positioned within the receptacle and, wherein each of the pair of spaced arms includes a surface positioned to engage a blood collection tube which is slip-resistant.

15. The blood collection device according toclaim 14, wherein the needle further comprises a distal end extending distally of the body.

16. The blood collection device according toclaim 14, wherein the retaining structure includes at least one finger nub, each of the at least one finger nubs being connected to one of the pair of arms by a pivot member, the at least one finger nub being actuable to disengage a respective one of the pair of arms from engagement with the blood collection tube positioned within the receptacle of the body.

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