Non-reusable collection device for bodily fluids

Non-reusable collection device for body fluids

Cross reference of related applications

This application is the U.S. Patent Part Continuation Application No. 12/846,402 filed on July 29, 2010, which is the U.S. Patent Part Continuation Application No. 12/ in the application filed on June 10, 2008 Part of the continued application under No. 136,462.

The present invention relates to medical devices for collecting body fluids from patients, and more particularly, for example, a vascular blood collection device, which is not reusable and provides protection from accidental needle sticks.

Conventional devices for drawing blood vessels or other body fluids from the patient have the needle exposed when they are withdrawn from the patient, thereby exposing the user of the device to possible needle sticks and being contaminated by contact with pathogens in the fluid. There is a need for a device that provides greater protection to both the user and the patient, is not easy to be reused by other patients, is easy to use, can be used, for example, with a conventional blood collection tube, and can be reliably manufactured in large quantities at a relatively low cost . Such a device is disclosed in this application.

The present invention discloses a medical device, which can be used in a conventional collection tube with elasticity at one end, usually a rubber stopper, to draw blood or other body fluids from patients or animals. The forwardly extending end of the device should preferably have a sharp needle that can be inserted into a patient's vein, for example. The rear end of the needle should also have a sharp needle, which can be inserted through the elastic closure, usually a rubber stopper, to seal the open end of the blood collection tube. The rear end of the needle is initially covered with a flexible elastic sheath, which can be pierced by extending the needle backwards, and then pushed forward and folded. This is because the needle also pierces the closure to establish the patients vein and blood collection tube through the needle Between the fluid flow. The collapsible elastic sheath covering the rearward needle also prevents fluid from escaping from the back of the needle before the needle is inserted into the blood collection tube. Once the desired amount of liquid has been collected, and when the collection tube is withdrawn from contact with the needle, the folded elastic sheath simultaneously expands to cover the original position of the needle. This prevents any blood remaining in the needle from escaping the needle or the back of the device before being retracted.

Another desirable feature of the present invention is that the extended needle can be retracted into the body of the device to prevent accidental needle sticks. This retraction is preferably started without removing the needle from the patient's body by pressing a trigger hinged near the back of the device. When the front end of the trigger is pressed against the body of the device, the backward extension needle is pushed into the trigger by the compression and retraction spring. After the retraction spring expands during needle retraction, the front needle remains inside the body of the device.

Another desirable feature of the present invention is the release mechanism used to activate needle retraction. Before being retracted, the needle is attached to a needle holder, which is biased backward by a compression and retraction spring, and is held in this position by a protruding earring rotatably installed inside the body of the device. When the front end of the trigger is pressed to initiate the retraction of the needle after body fluid collection, the trigger contacts the lug radially protruding from the lug, causing the lug to rotate into the body of the device. Due to the rotation of the lug earring, the aperture of the ring is moved to align with the co-formed lateral flange of the needle holder, thereby allowing the previously constrained needle holder to pass through the aperture. When the lateral flange passes through the aperture in the lug ear, the compression and retraction spring is released to drive the needle holder backward into the retraction cavity inside the trigger. It is believed that the rotary release mechanism is not like the one used to release the retracting spring in any conventional device with retractable needles, and combines reliable clamping and smooth operation release action. This smooth operation release action must be used by the clinician. Apply a relatively low trigger force.

According to a preferred embodiment of the present invention, a non-reusable device for collecting body fluids such as blood vessels from patients is disclosed. The device is configured to contain, for example, a blood collection tube and has a needle holder attached to a backward bias. Before the needle is retracted, the needle holder is constrained by the rotatably mounted lug earring, and during the retraction period, the lug earring is rotated by pressing the trigger pivotally connected to the body of the device. Release, so that the needle holder is driven into the retraction cavity provided inside the trigger, and the needle is held inside the body of the device before the needle.

The device of the present invention further refers to the description and explanation of the following drawings.

The same component symbols are used to illustrate the same parts in all figures in the drawings.

As shown in all or part of the drawings, the device 20 should be configured to facilitate the collection of body fluids from the patient, and preferably blood vessels. The device 20 is usually used in conjunction with, for example, the blood collection tube shown in Figures 7 and 8, which will be discussed further below with reference to these figures. The device 20 preferably includes a needle with two pointed ends connected by a common lumen. The common lumen makes it fluid so that any fluid flowing into the front end can flow out of the back end, for example, unless it is prevented from doing so. The needle should be supported inside the device 20 by a needle holder. The rearward tip of the needle should be covered with a flexible rubber sheath, which is fixed to the rear end of the needle holder by friction, adhesive, etc.

During a clinical procedure in which a sample of body fluid such as blood vessel blood is intended to be drawn from the patient, the forward protruding end of the needle is inserted into the patient's vein or artery. The device 20 is provided with a textured grip surface to facilitate this purpose, and the underside of the device 20 should be generally flat to allow the needle to be inserted at an almost flat angle relative to the patient's body. The fluid collection tube with a rubber stopper should be inserted into the device 20 through the opening at the rear and moved forward into the device 20 until the rubber at the rear end of the needle meets the resistance of the rubber stopper. When this happens, since the rubber sheath is usually more flexible than the rubber stopper, the needle pierces the sheath, the sheath is folded around the needle, and the needle advances through the stopper. Once the needle has penetrated the plug of the fluid collection tube toward the rear, the body fluid flowing into the needle from the patient at the front end can flow through the needle and into the fluid collection tube. The fluid collection pipe is usually discharged sufficiently so that the fluid does not flow out and flows into the pipe. When the desired amount of fluid has been collected, the tube is withdrawn from the device 20, and when the needle exits the plug toward the rear, the rubber sheath expands downward again to cover the currently exposed needle. The rubber used to make the rubber sheath should have sufficient elasticity so that when the needle is withdrawn, the hole pierced by the needle is closed, thereby preventing fluid from accidentally flowing out of the back of the needle when the needle is still inserted into the patient.

In this stage of using the conventional device to withdraw clinical vascular fluid, the front needle is withdrawn from the patients vein or artery, and the naked needle that may be contaminated by blood-borne pathogens will be used by the clinician before being disposed of in an approved sharps container, etc. Bring risks. In many cases, this occurs during accidental needle sticks and infections. For this reason, the device 20 is specially modified and configured to withdraw the front needle from the patient and allow it to enter the body of the device 20 to greatly reduce any accidental needle sticks or any contamination caused by direct contact with the needle or the carrier fluid on it. opportunity.

Referring to FIGS. 1-2, the device 20 preferably includes a body 22, an elongated trigger 24, a needle holder 50, and a retractable needle 28. The body 22 preferably further includes a front opening at the front end of the nose 40, a rear opening 34, a flange member 38 protruding outward, and finger grips 30 arranged on each side. The finger grip 32 should also be present at the upper end of the trigger 24 opposite to the hinge support 36 of the main body 22, and the trigger 24 is pivotally connected to it. Before attaching the needle holder 50 of the retractable needle 28, the needle 26 should pass through the front opening of the nose 40 not shown in FIGS. 1-2, and extend slightly through the nose 40 of the body 22.

The structure and assembly of the device 20 are further explained and explained with reference to Figs. 1-7. The trigger 24 is preferably an elongated member, generally shaped like an inverted U, with a forward open end 96 (Figure 7), and a closed end disposed opposite each other. The closed end includes two opposite laterally protruding protrusions 44 (second , 4 and 5). In this embodiment of the present invention, the raised surface 44 is used as a hinge pin, which engages with the hinge support 36 on the body 22 during the assembly of the device 20, although other similar effective structures can also be used to pivot the trigger 24. The rear part to the body 22. The frictional engagement between the protruding surface 44 and the hinge support 36 should be sufficient to prevent the trigger 24 from accidentally detaching from the body 22 during the use of the device 20, but it should not be so large that the cooperating cavity of the protruding surface 44 in the hinge support 36 after assembly The internal rotation provides significant resistance. Preferably, a rearwardly protruding stop member 46 is provided to limit the upward rotation of the trigger 24 relative to the body 22 during the use of the device 20. Preferably, the lower side of the trigger 24 (orientated as shown in Figure 7) is opened up to the main part of its length, and the bottom wall 47 is provided near the rear. As will be discussed in more detail below, the interior space of the trigger 24 is used as a retraction chamber 90. During the retraction after body fluid collection, the main part of the retractable needle 28 and the other parts of the needle retraction assembly are retracted into the retraction chamber. Back to cavity 90. For example, a textured finger grip surface including a plurality of laterally arranged ridges 32 is preferably provided on the top surface of the trigger 24 adjacent to the free open end 96. Referring to FIG. 7, the contact surface 94 of the chamfered lug generally facing downward relative to the main body 22 is also suitable to be disposed adjacent to the open end 96. The function of the lug contact surface 94 is further explained below.

As shown in Figures 6 and 7, the body 22 has a substantially tubular side wall defining an inner cavity 92. In the preferred embodiment, the inner cavity 92 has a diameter sufficient to accommodate a conventional fluid container such as a blood collection tube 76. The container can be slidably inserted through the rear opening 34. The side wall of the body 22 is preferably used as a guide to keep the blood collection tube 76 approximately coaxially aligned with the body 22 and the needle 28 during the use of the device 20, and the length of the body 22 should be set as a part of the tube 76 for easy maintenance It is grasped by the clinician to facilitate the removal of the tube 76 in the body fluid collection. Referring to FIGS. 1-5, finger grips 30 including, for example, a plurality of closely spaced ridges, texture surface portions are preferably provided on each side of the body 22 to assist the clinician in holding the body 22 during use of the device 20.

In particular, referring to Figures 2-4, 6 and 7, the body 22 preferably further includes an elongated, longitudinally extending, upwardly long slot 72 that is sized and configured to act as the open end 96 of the trigger 24 from the hinge When the support 36 pivots downward relative to the main body 22, the front part of the trigger 24 is received into the long slot 72. The recessed front portion 42 on the side and front of the slot 72 helps the trigger 24 move down into the slot 72. The front end of the body 22 preferably includes: a tapered nose 40 having an inwardly tapering diameter; and a front opening having an inner diameter slightly larger than the outer diameter of the needle 26 before the needle holder 50. With reference to Figures 1 and 7, the length of the nose 40 should be fixed. Before the needle holder 50, the needle 26 slightly extends beyond the nose to help the needle holder 50 be inserted into the body 22 as needed, and the needle 28 is attached. To the needle holder 50.

In particular, referring to FIGS. 2 and 7, the needle retracting assembly, which preferably includes the protruding earring 62, the needle holder 50, and the compressible retractable spring 70, is preferably placed in the front portion of the body 22. Although it is known that other similarly effective structures can also be used to retract the needle into the front part of the body 22, a satisfactory structure includes a plurality of circumferentially spaced hooks or arc-shaped sections 104, 106, and these sections are configured It has sufficient flexibility to allow the earring 62 to pass in the forward direction during installation, but it is configured to be rigid enough to resist the biasing force of the compression spring 70 and keep the needle retracted before being retracted. The return assembly is in the axial position shown in Figure 7. When seated and supported in the body 22 in this way, the lug earring 62 can rotate around the longitudinal axis of the device 20, but as described below with reference to Figures 10-14, this rotational movement is restricted by other structures. The needle holder 50 preferably includes a longitudinal lumen disposed in the center, which is sized and configured to allow the needle 28 to pass through the longitudinal lumen. The lateral flange 52 is preferably provided on the outside of the needle holder 50. The lateral flange 52 is preferably sized and configured to keep the compression and retraction spring 70 disposed in the nose 40 and around the needle holder 50. The forward end of the spring 70 should preferably abut the annular shoulder just behind the front opening of the nose 40.

During the assembly of the device 20, the flexible elastic sheath 56 with the open end 58 and the closed end 74 is preferably attached to the head 54 and the neck 60 of the needle holder 50 as if by friction engagement. The protruding earring 62 is placed above the sheath 56 and the head 54 of the needle holder 50. Before the needle holder 50, the needle 26 is inserted into the spring 70, and the assembly is inserted into the body 22, the lug 62 is positioned so that the aperture 102 (for example, visible in Figures 10 and 14) provided in the center of the lug 62 is not aligned This allows the lateral flange 52 (visible in FIG. 12) of the needle holder 50 to pass through the aperture 102. When the lug earring 62 is arranged in this manner, the needle holder 50 is preferably held in the position shown in Figures 6 and 7 before the needle is retracted. As shown, for example, in Figures 10-14 and discussed in more detail below, the lug 62 preferably further includes at least one lug 64 that protrudes outwardly. After the needle is retracted into the body 22, the needle 68 can be inserted behind the needle 28, pass the needle holder 50 before the needle 26, and advance backward until the rear needle 68 approaches but does not touch the flexible elastic sheath 56 To the closed end 74 (Figure 2). When properly positioned relative to the needle holder 50, it is preferable to use an appropriate conventional mechanism, such as adhesive laser welding, etc., to attach the needle 28 to the needle holder 50. As shown, for example, in FIGS. 2 and 7, the needle 28 preferably has an upward slope at the front needle 66 and a reverse slope at the rear needle 68.

Referring to Figures 1-5, the body 22, the trigger 24, the earring 62, and the needle holder 50 are preferably made of injection-molded polymer resin generally used for manufacturing similar medical devices, but polymer materials are not required. In the case of using polymer materials, all parts do not need to be made of the same polymer material.

Referring to Figure 6, a preferred embodiment of the device 20 described herein is shown in its pre-use configuration. Although it can be seen that even if the device 20 should be transported inside a sterile package, it can still be protected by a needle cover (not shown) before use. Front needle 66. In the pre-use position, the front part of the trigger 24 can be pivoted downwards into the rest position inside the upward long groove of the main body 22 as shown in the figure. As indicated by the arrow 84, the fluid collection tube 76 enters the body 22 forward through the rear opening 34. Therefore, the top of the rubber plug 80 contacts the lower side of the trigger 24 and causes the front end of the trigger 24 to rotate upward relative to the body 22. The position shown in Figure 7. When the trigger 24 is in the position shown in FIG. 7, the rearward projection 46 of the trigger 24 contacts and abuts against the bottom of the recess 48 (visible in FIG. 2) to limit the movement of the trigger 24 relative to the body 22. When the fluid collection tube 76 (FIG. 6) is advanced, the rear needle 68 pierces the elastic sheath 56 and then the rubber plug 80 to establish fluid communication with the interior 92 of the tube member 78. When this happens (shown most clearly in Figure 15 taken from Figure 7), the elastic sheath 56 is folded into the annular space around the needle 28 in front of the rubber stopper 80.

With reference to Figures 10 and 11, the lugs 64 preferably protruding outward from the lug 62 should be positioned in the non-return claws of the smoothly arranged lug 100, which is opposite to the lug 64 from the body 22 The part protrudes inward. The protruding surface 100 prevents the protruding earring 62 from rotating relative to the body 22 and the lateral flange 52 of the needle holder 50 before the needle is retracted. When the earring 62 is positioned as shown in FIGS. 10 and 11, the lateral flange 52 of the needle holder cannot pass through the aperture 102 of the earring 62. The biasing force of the spring 70 (FIG. 7) applied against the front surface of the lateral flange 52 is restricted by the lug 62 until the lug 62 is rotatably repositioned inside the body 22. Reading this disclosure, it should be understood that the lateral flange 52 and the aperture 102 can each have an unlimited number of different shapes, but the premise is that the lateral flange 52 and the aperture 102 are restricted only in the lug earring 62 as shown in Figs. 10-11. When the position is rotated to the unconstrained position shown in FIGS. 12-14, the transverse flange 52 can pass through the aperture 102.

Referring to FIG. 8, after the fluid collection tube has been filled to the desired level after the body fluid is withdrawn from the patient, the clinician using the device 20 will hold and withdraw the collection tube 76 from the cavity 86 as indicated by the arrow 87. When this happens, the rubber stopper 80 seals the tube 76 to prevent fluid from leaking from the tube, and the rubber sheath expands backward to cover the rear needle 68 to prevent any body fluids still contained in the needle 28 from leaking out of the rear of the body 22 . Then, the needle 28 can be directly retracted from the patient by pressing the free end of the trigger 24 into the upward long groove of the main body 22, passing the rest position shown in Figure 6 to the point where the needle retraction occurs.

Referring to Figures 12-14, when the front end of the trigger 24 is pressed into the body 22, the downward contact surface 94 of the trigger 24 contacts the opposite, upward surface of the lug 64 of the lug 62, thereby forcing the lug The ear 64 passes through the protrusion 100 of the body 22, and at the same time, as shown by arrow 65 (Figure 13), rotate the lug 62 until the horizontal flange 52 and the aperture 102 are aligned at the position where the transverse flange 52 is no longer restricted by the lug 62 . Referring again to Figure 8, when the protruding earring 62 reaches the position where the needle holder 50 is released, the spring 70 rapidly expands and acts on the front surface of the lateral flange 52 of the needle holder 50 to drive backward and attach the elastic The sheath 56 and the needle holder 50 of the needle 28 enter the retracting cavity 90 of the trigger 24. When this happens, the protruding earring 62 and the protruding ear 64 remain in the position shown in Figure 12, the needle 28 is inclined upward, and the needle 66 before the needle 28 is retracted into the nose 40 of the body 22 to anyone, whether it is Patients, clinicians or other bystanders are then faced with the possibility of potentially contaminated needles, accidental needle stick injuries and/or infection. Since the needle 28 is then grabbed into the inside of the device 20, the possibility of reuse of the device 20 is also eliminated.

With reference to Figures 16-21, another embodiment 200 of the present invention is substantially the same as the foregoing, except that the cross bar 220 is provided between the upright and opposed hinge supports 213, 214 to limit the trigger during needle retraction. Before and after the forward extending end of 212 is pressed relative to the main body 210, the rearwardly protruding stop member 222 moves or moves upstream relative to the main body 210 (shown most clearly in Figures 18 and 21). Figures 16-18 show the rest position of the trigger 212 relative to the body 210 before the needle is retracted, and Figures 19-21 show the rest position of the trigger 212 relative to the body 210 after the needle is retracted. The raised position of the trigger 212 with respect to the main body 210 facilitated by the crossbar 220 before the retraction indicates that the needle has not retracted, and also helps to protect from premature retraction during shipment.

During the retraction of the needle, when the front part of the trigger 212 is pressed into the body 210, the rearwardly protruding stop member 222 rises away from the notch 224 and engages with the lower side of the cross bar 220. Depending on the thickness and the material of the crossbar 220, the trigger 212 will be pressed into the main body 210 to initiate the retraction, and will bend or bend upward to a greater or lesser degree. When in a bent or flexed position (not shown) relative to the main body 210, the cross bar 220 limits the degree of downstream movement of the front portion of the trigger 212 relative to the front portion of the main body 2010.

After the user has retracted the needle and after the user no longer presses the trigger 212 down, the natural elasticity of the material used to make the crossbar 220 allows it to roughly return to the pre-retracted position relative to the main body 210, but More generally, due to some upward bending or deformation of the crossbar 220 after retraction, relative to the front surface of the main body 210, the retracted rest position of the front surface of the trigger 212 is lower than the retracted front position. For example, Figures 19-21 show the change in resting position after retraction. Although the crossbar 220 can be manufactured separately and then attached to the opposite hinge supports 213, 214 using any suitable fasteners or adhesive welding technique, the crossbar 220 is preferably formed as a part of the body 210 and/or hinge Support 213,214.

Refer to the description based on the accompanying drawings, those skilled in the art should also be aware of other changes and modifications of the present invention, and the scope of the invention disclosed here is intended to be limited to the broadest interpretation of the scope of the attached application specific examples that the inventor legally possesses.

<p>20. . . Device</p><p>twenty two. . . Ontology</p><p>twenty four. . . trigger</p><p>26. . . Front needle</p><p>28. . . Retractable needle</p><p>30. . . Finger grip</p><p>32. . . Finger grip</p><p>34. . . Back opening</p><p>36. . . Hinge support</p><p>38. . . Picture edge component</p><p>40. . . Nose</p><p>42. . . Front part</p><p>44. . . Raised face</p><p>46. . . Protruding</p><p>47. . . Bottom wall</p><p>48. . . Notch</p><p>50. . . Needle holder</p><p>52. . . Cross flange</p><p>54. . . head</p><p>56. . . jacket</p><p>58. . . Open end</p><p>60. . . neck</p><p>62. . . Stud earrings</p><p>64. . . Lugs</p><p>66. . . Front needle</p><p>68. . . Back needle</p><p>70. . . spring</p><p>72. . . Long slot</p><p>74. . . Closed end</p><p>76. . . (Fluid) blood collection tube</p><p>80. . . Stuffed</p><p>86. . . Cavity</p><p>90. . . Retraction cavity</p><p>92. . . Lumen</p><p>94. . . Lug contact surface</p><p>96. . . Open end</p><p>100. . . Raised face</p><p>102. . . Porosity</p><p>104,106. . . Arc segment</p><p>200. . . Another embodiment</p><p>210. . . Ontology</p><p>212. . . trigger</p><p>213,214. . . Hinge support</p><p>220. . . Crossbar</p><p>222. . . Stop member</p><p>224. . . Notch</p>

Figure 1 is a simplified perspective view of a device used to collect body fluids such as blood, in which the device is roughly oriented in a vertical position, and the forward extension of the device generally points in a downward direction;

Figure 2 is an exploded exploded view of the device in Figure 1;

Figure 3 is a top view of the device in Figure 1 when it is oriented in a horizontal position;

Figure 4 is a side view of the device in Figure 1 when it is oriented as shown in Figure 2;

Figure 5 is the left end view of the device of Figure 1 when it is oriented as shown in Figure 4;

Figure 6 is a cross-sectional view taken along line 6-6 of the device in Figure 3, which shows the pre-use configuration of the fluid collection tube inserted into the device;

Figure 7 is a cross-sectional view of the device of Figure 6 after the fluid collection tube is inserted into the device;

Figure 8 is a cross-sectional view of the configuration of the device in Figure 6 after use and before being retracted, the retracting spring expands, and the front needle is retracted into the body of the device;

Figure 9 is a simplified and reduced view of Figure 4, and the section line shows the position and direction taken along line 10-10 of Figure 9;

Figure 10 shows a simplified cross-sectional view taken along line 10-10 of Figure 9;

Figure 11 is an enlarged detailed view taken from the cross-sectional view of Figure 10, showing the lugs, lugs and contact surfaces of the trigger before use and retracted positions;

Figure 12 is the device shown in Figure 10, but the trigger is pressed against the body, and the lugs and lugs are rotated to the retracted position;

Figure 13 is an enlarged detailed view taken from the cross-sectional view of Figure 10, showing the lug, lug and contact surface of the trigger in the retracted position;

Figure 14 is the device after retracted as shown in Figure 12;

Figure 15 is an enlarged detailed view taken along Figure 7;

Figure 16 is a simplified top and rear perspective view of another preferred embodiment of the device for collecting body fluids such as blood, in which the needle and the trigger (or pivotable actuator) are arranged in the protruding and retracting front positions, And wherein, the body of the device is provided with a cross bar, which limits the upward pivoting movement of the rear part of the trigger relative to the rear part of the body after the needle is retracted;

Figure 17 is a detailed drawing taken from Figure 16;

Figure 18 is a cross-sectional front view taken along line 18-18 of Figure 17;

Figure 19 is a simplified top and rear perspective view of another preferred embodiment of Figure 16, in which the needle is retracted, and the trigger is arranged in the retracted position, and wherein the body of the device is provided with a cross bar, which is in the needle After retracting, restrict the upward pivoting movement of the rear of the trigger relative to the rear of the body;

Figure 20 is a detailed drawing taken from Figure 19; and

Figure 21 is a cross-sectional front view taken along line 21-21 of Figure 20.