|Número de publicación||USRE39107 E1|
|Tipo de publicación||Concesión|
|Número de solicitud||US 09/665,634|
|Fecha de publicación||23 May 2006|
|Fecha de presentación||19 Sep 2000|
|Fecha de prioridad||23 May 1997|
|También publicado como||CA2291660A1, CA2291660C, DE69833428D1, DE69833428T2, DE69839928D1, EP0983100A1, EP0983100A4, EP0983100B1, EP1656962A2, EP1656962A3, EP1656962B1, US5810775, WO1998052630A1|
|Número de publicación||09665634, 665634, US RE39107 E1, US RE39107E1, US-E1-RE39107, USRE39107 E1, USRE39107E1|
|Inventores||Thomas J. Shaw|
|Cesionario original||Retractable Technologies, Inc.|
|Exportar cita||BiBTeX, EndNote, RefMan|
|Citas de patentes (66), Citada por (21), Clasificaciones (19), Eventos legales (3)|
|Enlaces externos: USPTO, Cesión de USPTO, Espacenet|
1. Field of the invention
The invention pertains to a retractable medical device which in the preferred embodiment is useful for collecting body fluids from a patient. It is primarily useful as a blood collection device.
2. Background of the Prior Art
Prevention of needle sticks has become a paramount concern of the healthcare industry because of serious and deadly risk factors associated with AIDS and other serious communication diseases. 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 potentially lethal.
Illustrative of the type of device used for blood sampling is a collection device sold under the trademark Vacutainer® by Becton Dickinson Corporation, which has been the conventional standard for this type of device. It 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 When a sufficient sample has been obtained, the collecting tube and the stopper are simply withdrawn from the tubular shell and sent to the laboratory.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.
Retractable medical devices which are used for collecting fluid samples from patients are known. While they offer retraction of the needle, they suffer from high manufacturing and assembly cost. They lack simplicity which results in a multiplicity of difficult to manufacture and assemble parts. An early example of such a device is Haber U.S. Pat. No. 4,813,426 which employs a mechanically translatable insert holding a double-ended needle. It has a position which compresses a spring portion of the holder. When buttons extending from opposite sides of the outer tube are compressed, the needle carrier can be mechanically moved to the position of us or to a rearward safe position. Allard U.S. Pat. No. 4,838,863 describes a spring loaded double ended needle carrier in a T-shaped housing having an opening behind for the sample tube. The needle holder is locked in a use position with a removable pin which is withdrawn to retract the needle. Alternately, breakable tabs on the needle holder extend laterally under a shelf with pins which may be pushed down when the sample tube is inserted to fracture the breakable tabs thereby releasing the needle holder which is withdrawn into the interior as the sample tube is removed. Subsequently, a cap is provided to close the back. Allard does not explain how one could assemble the device without making the outer body in two or more pieces.
In addition, a number of devices attach the double ended needle to a partially withdrawable plunger with an opening in back for the sample tube. Shaw U.S. Pat. No. 5,423,758 discloses a tubular outer body with a partially removable plunger. The plunger has a separable needle holding portion for a double ended needle and an opening in the back of the plunger for a sample tube. It utilizes a two position end cap from which the sample tube extends. The plunger is used to position and retract the needle assembly.
By in large, the prior art fails to take into account the need for a single one-handed required and controlled action that will simultaneously close the back of the main body of the device and initiate retraction of the exposed needle after the sample tube is removed. If the inner needle which punctures the collection tube is not covered with a rubber sheath, blood will continue to flow into the device. This blood provides a source of contamination during subsequent handling of the device. If the internal needle is covered with a rubber sheath to prevent the blood from continuing to flow after the collection tube is removed, the rubber sheath serves to hide a sharp needle which can result in unintended punctures. Since the sheathed needle looks safe, people tend to put their finger into the open end without thinking. Even if a cap were to be provided, it use requires a separate operation and it is easy to forget or simply fail to use it. Consequently, an improvement in safety is possible with a device that caps the back of the device while it is retracting.
The invention is a retractable medical device in the form of a blood sampler which can be operated by one hand without removing the device from the patient after one or more collection tubes are filled. While one hand holds a gauze pad over the puncture site, the other hand is used to manipulate a cap hingedly connected to the back of the device. As the cap is moved to the closed position, it moves a movable member forward releasing a retraction body with the needle which is retracted entirely within the walls of the now closed body. Once retracted, the sharp double ended needle is confined and cannot be used. Safety is assured because the act of closing the cap is the same act which causes retraction of the needle. It is the only way retraction can take place.
The cap operated retractable medical device includes a long thin walled tubular outer body having a back end with an opening and a front end which incorporates a centered hub which provides an opening for a needle holder. A long thin walled tubular movable member closely fits entirely within the outer body. The movable member has a back end with an opening and a front portion wherein the front portion has a radially enlarged inner surface and an outer surface. A retraction body having a disk-like laterally extending wall with an outwardly facing edge is releasably held within the movable member at a forward position by means of cooperation between the radially enlarged inner surface of the front portion of the movable member and the outwardly facing edge.
A thickened or stepped in portion of the wall of the outer body is provided for a short distance behind the front wall. The hub, preferably in the form of an annular ring, serves as a stop for the retraction body spaced behind the front wall of the outer body. It also serves to hold the front end of the compression spring which is placed between the front wall of the outer body and the retraction body. The movable member is held in position within the outer body, with the retraction body adjacent the hub, by means of a tight area created between the outer surface of the movable member and the stepped in or thickened inside surface of the wall of the outer body near its front end. The retraction body carries a double ended needle.
A cap which is hinged at the back end of the outer body is selectively movable between an open position and a closed position relative to the opening of the back of the outer body. The cap includes a cam surface configured to engage the back end of the movable member inside the outer body and move it forward as the cap is moved to the closed position. Closing the cap causes the movable member to move forward while the retraction body is restrained by the hub in the outer body thereby releasing the retraction body from the movable member. A spring compressed under the retraction body expands to drive the retraction body and double ended needle backward within the movable member just as the cap is fully closed. Another stepped in portion of the wall of the movable member near the back end catches the retraction body before the needle behind the retraction body can reach the area of the cap.
The tight area between the outer surface of the movable member and the inner surface of the outer body near the front of the device is in the nature of an interference fit which still allows the movable member to go forward when the cap is closed. Since the forwardly extending needle of the blood sampler does not need to puncture a rubber seal as does a syringe, the retraction body and movable member do not have to resist large forces before releasing. The rearward facing portion of the needle in the device does have to puncture the seal of a collection tube, but since the retraction body is positioned against a hub or stop at the front of the outer body and cannot move forward, impaling the collection tube on the interior end of the needle cannot disassociate the retraction body from the movable member.
The needle holder is carried by the retraction body with the needle extended in both directions. In the assembled condition, the conjunction of the retraction body and the hub provide a convenient means for installing the already assembled needle holder and needle through the opening in the front wall of the outer body. The needle holder is threaded into a centrally located opening in the retraction body. The centrally located opening of the retraction body has a forwardly extending tubular wall which cooperates with the hub to confine the spring between the hub and the retraction body. Since the spring closely circumscribes the tubular wall of the retraction body, it serves to stabilize the retraction body so that it tends to move straight back without tilting during its retraction.
The cap has an outer rim larger than the opening at the back of the outer body and an inner rim containing one or more camming protrusions which cam the back of the movable member when the cap is closed. The inner rim preferably comprises two camming protrusions which are spaced apart and positioned to enter the opening when the cap is moving to the closed position. The protrusions are oppositely positioned along the inner rim about half way from the hinged connection. The protrusions actually contact the back of the movable member before the cap is closed and continue moving the movable member until retraction occurs just as the cap is becoming fully closed.
A fail-safe design is provided. The needle can only retract when the cap is closed. Since the cap is hinged to the device, it cannot be lost or misplaced. There is little chance of premature retraction since retraction can only be initiated by closing the cap. Even if retraction is forced by pushing the needle against a solid object, the needle does not come out of the body. Once the cap is closed to retract the needle, no special handling is required. A sound is made when the retraction occurs. The fact that the cap is closed together with the sound assures that the needle is no longer exposed, even without looking. An additional visual indication is also provided by the clear plastic walls of the outer body and movable member which enables the user to visually observe the extended spring that proves retraction has occurred.
The parts are fewer in number than other retractable devices comprising only an outer body which can be molded as one together with the cap, the movable member, the retraction body and the needle assembly. Due to the fact that the movable member is contained entirely within the outer body, a more compact device is made possible, limited in length only by the space required to enclose the double ended needle. The parts are suitable for fabrication in multiple cavity high speed plastic injection molding machines. No special materials are utilized apart from the usual plastic materials employed in the syringe industry.
Assembly is simplified by sliding interference fitting of the parts in a straight line direction. First the retraction body is inserted from the rear of the movable member and moved forward to fit within its mouth. The back end of the compression spring is placed over the tubular extension and into a spring groove of the retraction body while the outer end is dropped into a hub at the front of the outer body as the movable member is moved forward to compress the spring. Then the movable member is moved forward until the front end slidingly engages the stepped in portion of the outer body which creates a tight area where the movable member is held and the retraction body is positioned just above the hub which serves as a stop. The needle assembly is then screwed into the retraction body through the opening in the front wall of the outer body. A removable protective cap can be placed over the exposed needle until the device is ready for use.
The medical device is generally referred to by the reference numeral 10 in FIG. 1. The device 10 is a fluid collection device, ore particularly a blood sampler. Device 10 has an elongated body 12 having a partially closed front 14 and an open back 16. There is an intermediate wall portion 18 connecting front 14 and back 16. Intermediate wall portion 18 has an outer wall surface 20 and an inner wall surface 22 which defines a hollow interior 24. Inner wall 22 together with open back 16 forms opening 26 at the back of outer body 12. A flange 17 is positioned at the back of outer body 12 to serve as a grip. It may be noted that flange 17 could be moved forward along body 12 if desired and is not necessarily located at the back of the body 12. In this regard, the forward direction is the direction in which the external needle 88 is extended.
Cap 30 is positionable between an open position as shown in FIG. 1 and
An elongated movable member generally designated 40 in
Referring now to
Retraction body 60 is best seen in
Retraction body 60 further includes a forwardly extending tubular wall 66 having a centrally located opening 68 which extends longitudinally along the central axis of the assembled device. Longitudinally extending opening 68 has an inner wall surface 70 which may have threads or a plurality of angularly spaced sets of radial protrusions 72. Radial protrusions 72 can serve as a thread substitute for securing a threaded needle holder 74 best seen in
The radially enlarged surface 58 of front end portion 54 of movable member 40 is slidably held by a portion of inner surface 22 of outer body 12 at a location spaced behind partially closed front wall 14 of the outer body. Intermediate wall 18 has a thickened portion 92 which extends a short distance behind front wall 14. This creates an inner surface portion 94 which extends radially inwardly from inner surface 22 of intermediate wall 18. This creates a constricted area in a band around the inside of outer body 12 adjacent front wall 14. A smooth ramp 96 leads into thickened area 92 whereby movable member 40 can be moved forwardly until outer surface 58 slidably engages surface 94 thereby creating a tight area in a band between surfaces 58, 94 which holds movable member 40 in the position shown in FIG. 1. The tight area is a sliding interference fit between the front portion of the movable member and the inner surface of the outer tube. Alternately, thickened area 92 could be a plurality of angularly arranged land areas which engage portions of outer surface 58. A great degree of holding force is not needed since the front portion of needle 88 is primarily designed to puncture skin and it not normally used to pass through rubber stoppers commonly used in vials.
Thickened area 92 may be regarded as creating a stepped in portion on the inner surface of body 12 which cooperates with outer surface 58 of the front portion of the movable member to create the tight area whereby the movable member is held in its forward position shown in FIG. 1. The stepped surface creates a smaller diameter for a short distance behind front wall 14 which clamps radially enlarged outer surface 58 when the movable member is introduced through opening 26 and moved forward until the cooperating surfaces 58 and 94 slidingly engage. Some compressive force is directed around the mouth of member 40 toward retraction body 60 which is held inside. The forwardly extending tubular wall 66 in cooperation with hub 28 serves to confine biasing spring 77 between the hub and the retraction body. The flanged wall portion 84 forms the opening 86 for needle holder 74 which is smaller than the diameter of the spring. Flanged portion 84 thus supports the spring at its forward end. In its use position in
Assembly of device 10 is simple and well suited for automated assembly. First retraction body 60 without the needle holder is pushed through the open back end of movable member and moved forward with a tool until cooperating edge 64 and inwardly facing surface 56 are engaged at the mouth of movable member 40. The back end of spring 77 is positioned circumscribing tubular wall 66 of retraction body 60 and the front of the movable member holding the retraction body and the spring are pushed into opening 26 at the back of outer body 12. The front end of spring 77 is seated into a well-like opening 104 within hub 28 at the front of the outer body. A tool may be inserted through opening 86 to serve as a guide for the spring as it moves forward and prevent lateral buckling of the spring as it is compressed. Movable member 40 is moved entirely within outer body 12 until the outwardly facing surface 58 engages the cooperating stepped in surface 94 and moved forward until surface 63 of the retraction body reaches stop 86. Threaded needle holder 74 together with needle 88 is then placed into opening 86 and turned to secure it in place in retraction body 60. Finally, a removable protective cap (not shown) is placed over the exposed portion of needle 88 and device 10 is ready for sterilization and packaging.
In operation, the cap operated retractable medical device is supplied as shown in
As cap 30 is pivoted into a blocking position with respect to the opening 26, protrusions 38 come in contact with back end 50. As the thumb pushed cap 30 further into cavity 24, movable member 40 moves forward along surface 94 toward front wall 14. An annular stop 86 prevents retraction body 60 from moving forward with movable member 40. Stop 86 disassociates retraction body 60 from the mouth of the movable member. Retraction body 60 is freed from front portion 54 of the movable member by relative movement between edge 64 and surface 56. When retraction body 60 comes free, spring 77 acting on retraction body 60 then drives retraction body 60 backward carrying needle 88 into outer body 12. Constriction 98 which constitutes a stepped in portion 100 of the wall of the movable member prevents retraction body from further rearward movement beyond the retracted position of FIG. 2. Cap 30 completely closes the back of the outer body 12 in a friction fit. Coil spring 77 which closely circumscribes the tubular wall 66 of retraction body 60 tends to stabilize the retraction body as it is retracting so that it moves straight back without tilting. In the retracted position of
In the best mode, it is anticipated that only about ⅛ of a pound needs to be generated by spring 77 in its fully compressed position since retraction body 60 is essentially free from restraint once it is dissociated from the mouth of the movable member. The outer body 12 in cap 30 can be molded as a single unit. Hinge 32 is preferably a so-called “living hinge” which is connected to the body 12 during the molding process. Body 12 would preferably come out of the mold with cap 30 in the orientation shown in FIG. 4.
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|Clasificación de EE.UU.||604/110, 600/576, 604/195|
|Clasificación internacional||A61M5/00, A61M5/31, A61M5/32, A61B5/15|
|Clasificación cooperativa||A61B5/150656, A61B5/154, A61M5/3232, A61B5/150389, A61B5/150496, A61B5/15003, A61B5/150572, A61B5/150351, A61B5/150732|
|Clasificación europea||A61B5/14B, A61B5/14B12, A61B5/14B12B|
|10 Oct 2000||CC||Certificate of correction|
|14 Ene 2009||AS||Assignment|
Owner name: RETRACTABLE TECHNOLOGIES, INC., TEXAS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SHAW, THOMAS J.;REEL/FRAME:022102/0876
Effective date: 19991110
|18 Mar 2010||FPAY||Fee payment|
Year of fee payment: 12