1. Field of the Invention
This invention relates generally to devices used to collect fluid samples from and/or inject fluids into patients. More specifically, this invention relates to a device which utilizes a holder utilizing a double-ended needle that can be released, retracted or removed from the holder in a more safe and easy manner. The device can be a single-use device or multi-use device. The invention also relates to a method of collecting a fluid sample with the device as well as a method of making the device. The invention also relates to a blood sample collection device that is easier to use, is less costly to produce, is safer to use, and/or is easier to manufacture.
2. Discussion of Background Information
Prevention of needle sticks is of paramount concern in the healthcare industry because of serious and deadly risk factors associated with AIDS and other serious communicable diseases. Typical blood collection devices utilize a needle inserted into a patient's vein so as to draw blood through the needle into an associated separate collection reservoir. Accidental needle sticks from previously used needles can occur during the fluid withdrawing process and subsequent handling and disposal operation. Until such used medical devices are destroyed, they remain a risk to those handling them.
Devices used for blood sampling are well know and include a collection device sold under the trademark Vacutainer® by Becton Dickinson Corporation. This device has a tubular syringe-like body with a needle in the front end, part of which extends back into a tubular syringe-like shell. Part of the needle extends externally for punching the skin. An evacuated collection tube with a rubber stopper is placed into the open back of the syringe-like shell with the rubber stopper against the internal end of the needle. After the skin is punctured, the collection tube is pushed forward to cause the needle to enter the evacuated tube. Vacuum helps draw blood into the collecting tube. When a sufficient sample has been obtained, the collecting tube and the stopper are simply withdrawn from the tubular shell and sent to the laboratory. This particular device has a permanently extended needle and an opening in the back for the collection tube which remains open after the collection tube is removed, leaving small quantities of blood and an internally exposed needle.
Medical devices which are used for collecting fluid samples from patients which have quick release needle systems are also known. Such devices include: U.S. Pat. No. 5,797,490 to FUJI et al; U.S. Pat. No. 5,755,673 to KINSEY; U.S. Pat. No. 4,822,343 to BEISER; U.S. Pat. No. 4,984,580 WANAMAKER; U.S. Re. 38,964 to SHILLINGTON; U.S. Pat. No. 5,616,136 to SHILLINGTON et al.; U.S. Pat. No. 5,637,101 to SHILLINGTON; U.S. Pat. No. 5,117,837 to WANAMAKER et al.; U.S. Pat. No. 4,907,600 to SPENCER; U.S. Pat. No. 4,993,426 to SPENCER; U.S. Pat. No. 4,904,244 to HARSH et al.; U.S. Pat. No. 4,490,142 to SILVERN. The disclosures of each of these documents is expressly incorporated by reference herein in their entireties.
Medical devices which are used for collecting fluid samples from patients which can benefit from the improvement offered by the instant invention include: U.S. 2010/0286558 to SCHRAGA; U.S. 2008/0262421 to SCHRAGA; U.S. Ser. No. 12/974,908 to SCHRAGA filed on Dec. 21, 2010; and U.S. 61/480,787 to SCHRAGA filed on Apr. 29, 2011. The disclosures of each of these documents is expressly incorporated by reference herein in their entireties.
The invention aims to improve devices of the type described above by making a needle assembly for a fluid collection device which includes a standard interface needle. The device is also believed to be as safe or safer to use and/or dispose-of than the above-noted devices.
According to one non-limiting aspect of the invention there is provided a fluid collection/injection device including one or more features shown herein in combination with one or more devices disclosed above. In embodiments, there is provided a fluid collection/injection device including one or more features shown herein in combination with one or more devices disclosed in U.S. 2010/0286558 to SCHRAGA; U.S. 2008/0262421 to SCHRAGA; U.S. Ser. No. 12/974,908 to SCHRAGA filed on Dec. 21, 2010; and U.S. 61/480,787 to SCHRAGA filed on Apr. 29, 2011. The disclosures of each of these documents is expressly incorporated by reference herein in their entireties.
The invention provide for a fluid collection device comprising a body having a front end and a back end. The back end that is at least one of open and sized and configured to receive therein a receptacle. A needle holding member is arranged in an area of the front end of the body. A needle holding member comprising a needle connecting interface adapted to mate with a needle interface.
The needle holding member may be a spring biased member that is movable from an initial position to a retracted position within the body.
The needle connecting interface may be a luer-lock interface, a standard interface and/or a universal interface.
The fluid collection device may further comprise a spring structured and arranged to move the needle holding member to a retracted position within the body when a movable member arranged with the body experiences at least one of: a front end of the movable member is caused to expand generally radially; a back end of the movable member is caused to contract generally radially; a front end of the movable member is caused to expand generally radially when a back end of the movable member is caused to contract generally radially; axial movement caused by a cap closing off the back end of the body, wherein, during the closing off of the back end of the body, a tapered surface of a back end of the movable member is contacted by a portion of the cap; circumferential portions of a front end of the movable member are caused to expand outwardly or generally radially so as to allow the needle holding member to disengage from the front end of the movable member; and portions of a front end of the movable member separated by slots are caused to expand outwardly or generally radially so as to allow the needle holding member to disengage from the front end of the movable member.
The invention also provides for a fluid collection/injection device comprising a body having a front end, a back end, and a main hollow section arranged between the front and back ends. A needle hub securing section is arranged on the front end and being structured and arranged to receive therein a needle member. The needle hub securing section comprises a fixed part and a movable part. A needle holding member is connectable to the needle hub securing section. The needle holding member comprising a needle connecting interface adapted to mate with a needle interface. The fixed part is integrally formed with the front end and the movable part is arranged on a member that has one end which is one of: fixed to a portion of the main hollow section; connected to a portion of the main hollow section via a living hinge; removably connected to a portion of the main hollow section; and integrally formed with the main hollow section.
The body may be one of generally cylindrical and generally tubular.
The fixed part and the movable part may form a generally cylindrical section which the movable part is in an initial position.
The fixed part and the movable part may each generally comprise one-half of an internal locking thread structured and arranged to engage with an external thread of the needle member.
The member may have one end which is fixed to the portion of the main hollow section.
The member may have one end which is removably connected to the portion of the main hollow section.
The invention also provides for a retractable medical device comprising a body having and a back end that is at least one of open and sized and configured to receive therein a receptacle, a movable member arranged within the body, the movable member having a back end and a front end, a movable holding member arranged in an area of the front end of the movable member, a needle connecting interface adapted to mate with a needle interface and being movable with the movable holding member, and a spring structured and arranged to move the movable holding member to a retracted position within the movable member when the movable member experiences at least one of: the front end of the movable member is caused to expand generally radially; the back end of the movable member is caused to contract generally radially; the front end of the movable member is caused to expand generally radially when the back end of the movable member is caused to contract generally radially; axial movement caused by a cap closing off the back end of the body, wherein, during the closing off of the back end of the body, a tapered surface of the back end of the movable member is contacted by a portion of the cap; circumferential portions of the front end of the movable member are caused to expand outwardly or generally radially so as to allow the needle holding member to disengage from the front end of the movable member; and portions of the front end of the movable member separated by slots are caused to expand outwardly or generally radially so as to allow the needle holding member to disengage from the front end of the movable member.
The needle connecting interface may be a luer-lock interface, a standard interface and/or a universal interface.
The invention also provides for a fluid collection/injection device comprising a body having a front end, a back end, and a main hollow section arranged between the front and back ends, a needle hub securing section arranged on the front end, a needle receiving member having a needle connecting interface, and the fluid collection/injection device is structured and arranged to utilize at least an operational mode, an operational mode, and a post-use mode, in the installation mode, the needle receiving member being coupled to the body via the needle hub securing section, in the operational mode, fluid passing through the needle receiving member and into or out of a receptacle inserted into the main hollow section; and in the post-use mode, a safety cover at least one of; prevents re-use of the fluid collection/injection device; prevents removal of the needle receiving member from the fluid collection/injection device; prevents removal of the needle receiving member from the needle hub securing section; locks in a covering position and prevents removal of a needle from the needle receiving member; activates release of the needle receiving member from the body such that when the safety cover is in a position covering a needle of the needle receiving member, the needle receiving member can fall out of the needle hub securing section; activates release of the needle receiving member from the body such that when the safety cover is in a position covering a needle of the needle receiving member, the needle receiving member is no longer securely retained to the needle hub securing section; releases a securing engagement between the needle receiving member and the needle hub securing section; unlocks a locking connection between the needle receiving member and the needle hub securing section; and moves a mechanism arranged in an area of the needle hub securing section which releases a connection between the needle receiving member and the needle hub securing section.
The needle connecting interface is a luer-lock interface, a standard interface and/or a universal interface.
The invention also provides for a method drawing fluid using the device of any of the types disclosed herein, wherein the method comprises installing the needle connecting interface and thereafter installing a needle having a standard interface on the needle connecting interface.
The invention also provides for a method drawing fluid using the device of any of the types disclosed herein, wherein the method comprises installing a needle having a standard interface on the needle connecting interface of the needle holding member so as to form a needle assembly and thereafter installing the needle assembly on the body.
The invention also provides for a method drawing fluid using the device of any of the types disclosed herein, wherein the method comprises installing a needle having a standard interface on the needle connecting interface and one of injecting fluid through the needle and withdrawing fluid into a container installed in the body via the needle.
The invention also provides for a needle assembly for a fluid collection device comprising a needle holding member installable on a fluid collection device, a needle connecting interface arranged on one end of the needle holding member, and a needle having a needle interface, wherein the needle is at least one of installable on the needle holding member such that the needle is in fluid communication with another needle arranged on the needle holding member and removably installable on the needle holding member.
The invention also provides for a double-ended needle assembly comprising a needle holding member installable on a fluid collection device and comprising a needle connecting interface arranged on one end of the needle holding member and a needle arranged on another end and a needle having a standard needle interface compatible with the needle connecting interface of the needle holding member.
The needle may be at least one of installable on the needle holding member such that the needle is in fluid communication with the needle arranged on the needle holding member and removably installable on the needle holding member.
Other exemplary embodiments and advantages of the present invention may be ascertained by reviewing the present disclosure and the accompanying drawing.
The present invention is further described in the detailed description which follows, in reference to the noted plurality of drawings by way of non-limiting examples of exemplary embodiments of the present invention, in which like reference numerals represent similar parts throughout the several views of the drawings, and wherein:
In
In
According to one non-limiting example, a user can connect these components while the cover 30 is installed to make for a more safe assembly of the assembly NA. Assembly of these components can also occur in a factory setting so that the assembly NA shown in
In
The devices described herein can also utilize one or more features disclosed in the documents expressly incorporated by reference herein. Furthermore, one or more of the various parts of the device can preferably be made as one-piece structures by e.g., injection molding, when doing so reduces costs of manufacture. Non-limiting materials for most of the parts include synthetic resins such as those approved for syringes, blood collection devices, or other medical devices. Furthermore, the invention also contemplates that any or all disclosed features of one embodiment may be used on other disclosed embodiments, to the extent such modifications function for their intended purpose.
It is noted that the foregoing examples have been provided merely for the purpose of explanation and are in no way to be construed as limiting of the present invention. While the present invention has been described with reference to an exemplary embodiment, it is understood that the words which have been used herein are words of description and illustration, rather than words of limitation. Changes may be made, within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the present invention in its aspects. Although the present invention has been described herein with reference to particular means, materials and embodiments, the present invention is not intended to be limited to the particulars disclosed herein; rather, the present invention extends to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims.
The instant application is a U.S. non-provisional Application that is based on and claims the benefit of U.S. provisional application No. 61/498,133, filed Jun. 17, 2011, the disclosure of which is hereby expressly incorporated by reference thereto in its entirety.
Number | Date | Country | |
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61498133 | Jun 2011 | US |