AUTO-RETRACLE BLE MEDICAL NEEDLE APPARATUS AND METHODS DESCRIPTION OF THE INVENTION This invention relates generally to medical needle devices and methods and in particular to devices comprising medical needles, which are self-retractable from a fully extended position during use. to a retracted position where the needle is fully stored and covered within a housing for safe disposal. On the other hand, the invention relates to medical products which can only be used once to eliminate cross contamination from one patient to another and those medical products, which have inherent sterile parts protected from contamination without the need for packaging additional. The problems associated with needle holder neglect are well known in the art of blood drawing, transdermal injection of drugs, catheter placement and other medical procedures using medical needles. Significant attention is paid to needle problems due to the current probability of being exposed to AIDS and Hepatitis. | Procedures involving the removal of the needle normally require a specialist to use aI hand to place pressure in the place of the wound where the! needle is being removed, while removing the device! of needle with the other hand. The tendency of specialists'It is usually to give more priority to wound careI I give it to the waste of the needle. This priority requires t either from a sharps container available toshort reach or other means of safe disposal without moving awayOn the patient's side. By providing proper care-it is1 often aggravated by the condition of the patient and mental state, for example, in burn care units and psychiatric ward. Proper disposal of a used or exposed needle, while taking care of a patient, is sometimes very difficult, if not impossible, under these conditions. : The widespread knowledge and associated history! with the care of needles and their waste problems have resulted in the conception and description of a large number of devices. Although some devices describe the application in the blood collection area, most contemporary related techniques are directed toward syringes and similar devices. The related technique j can be broadly classified into two categories,I 20 devices which operate manually, and devices i which comprise the retraction of a stand-alone needle. Manual removal is usually a procedure with two, hands, making wound care a secondary step or requiring an additional medical specialist. A known self-retracting syringe I 25 results from a vacuum force,while others generally involve the self-retraction that results from the release of a centered or off-center spring. ! There remains a needle to provide amost satisfactory solution to the techniques of the devicesI! of self-retractable needle. 1 The present invention dramatically decreases theI, dangers that result from needle-carrier related injuries that occur after insertion procedures! 0 of needles in patients. More specifically, the apparatus and method of this invention, constitute an important basis in1 the technique of self-retractable needle devices, as evidenced by the following objects and advantages realized by the invention over the prior art. 5? An object of the present invention is to provide!; an improved and novel medical retractable needle device, which protects the integrity of the tip and sterility of the! medical needle and other internal parts of the device until itsI use and which automatically retracts the needle i 0 'inside the housing after use. Another object of the present invention is, Provide a retractable medical needle device whichI is autonomous and does not require an additional container for your1 transport.
'Additionally, it is an object of this, invention provide a retractable needle device, medical where the needle retraction portion is in itsBeen relaxed before use, thereby extending theProduct life - - - 'Yet another object of the present invention is] provide a needle safety device for extracting blood with a barrel attached to a vacuum tube for1 blood acquisition, as is a collection tubeVACUTAINER blood "manufactured by Becton, Dickinson andCompany Another object of the present invention isI provide a needle cover for the device, theWhich is releasably attached to the housing during thetransport and storage of the device, but which can be fragilely detachable from the housing. I Another object of the present invention is! provide a means to release a needle assembly', assembled by distorting a portion of the housing instead ofrequire a button or other mechanical device to project through the wall of the housing. A further object of the present invention is to provide protection for the portion which is distorted so that it is not negligently deformed during the insertion and use of the needle and to remove the protection witha single digital movement immediately before - to retract the needle. Another object of the present invention is that it is useful only once to ensure that the needle is securely enclosed when retracted. Still another object of the present invention is to limit the number of injection molded parts for ease of manufacture. Additionally, it is an object of the present invention to provide an element ------ storage of force storage, which stores energy as the needle assembly of the apparatus is extended for use and the which provides the retraction force of the needle when releasing the needle assembly. A further object of the present invention is to provide a memory element which comprises a path i covered with fluid flow for the extracted blood. - - I Also, it is an object of the present invention to, canceling forces within the apparatus, which causes a regurgitant flow when the needle retracts. It is still another object of the present inventionI provide an improved IV catheter insertion apparatus andI novelty comprising an accommodation which maintains the! sterility of the medical needle, a catheter and other parts'25 internal of the device until its use and which -automaticallyin its entirety it retracts the needle inside the housingI after use. Another object of the present invention is to provide a means for viewing a "retrospective" of blood i within the IV catheter device as blood and affluent enters the device from a blood vessel.
! Perforated. - Additionally, it is an object of this! invention provide a method for using a syringefilled in where the firing force for the retraction of the needle is applied transversely to the axis of the medical needle. A further object of the present invention is to provide a syringe and a combination of apparatus formedical needle, where the syringe is filled before the! transport to a user and the medical needle assembly is extendable for use with the medical needle and is retractable for1 safe storage of the needle after use. I I Another object of the present invention isI? 20 provide a needle removal device _ withI energy in which a disposeror energy element is a compressible elastic tube i j. Still another object of the present invention isProvide a needle removal device, whereI '25 the tip of the needle used to make a percutaneous punctureIn the skin, it passes only once through a hole associated with the safe containment of the needle after use, the passage occurs only in the retraction of the needle. Yet another object is to provide a "quick release needle extension mechanism." Further objects and advantages of the invention will be apparent from the following description, or may be learned by practice of the invention, "Briefly summarized, the objects above.0. The aforementioned are achieved by an apparatus which comprises a retractable and retractable medical needle device, adapted for use in fluid collection and dispensing procedures, the device comprises a housing, a medical needle at least partially disposed within thehousing, an extension assembly for extending the needle from the housing to an extended state for use in a medical procedure and a release mechanism disposed in the housing to release the retention mechanism of its retained state, thereby causing that the member ofenergy storage retract the needle inside theI accommodation. The extension assembly comprises a coverIn order to protect the needle, an energy storage member disposed between the container and the needle in such a way that the energy storage member stores "energy as the needle is arranged to be used and aRetention mechanism by which the needle is retained to the housing in the extended state for use in aI medical procedure. It is notable that both of the energy storage member and the retention mechanism areI 5 arranged in an unstressed state prior to the extension of the needle and placing the device in the state of i retention. The method for using the retractable and extensible medical needle device comprises the steps of storing the 10 energy storage member and retention mechanism. in an unstressed state during a period prior to the preparation of the needle for use, extending the needle! from the housing, and releasing the retention mechanism and retracting the needle by means of the force of the energy I stored in the energy storage member,! after using the medical needle in a medical procedure.
II It should be noted that the direction of force to release the retention mechanism is generally normal along the length of the needle. 120 BRIEF DESCRIPTION OF THE DRAWINGS i In order to fully understand the manner in which the advantages and objects of the invention and above are obtained, a more particular description of the invention will be given by reference to "T-" the specific modalities of it, which are illustrated in thei attached drawings. It will be understood that these drawings representOnly the typical embodiments of the invention and which therefore should not be considered as "limiting in the scope, the current preferred embodiments and the best current understood form of the invention, will be described withAdditional details through the use of the attached drawings] in which: Figure 1 is a perspective view of a sealed device - for drawing blood, showing theJLO exterior of the device housing. Figure 2 is a perspective view of theThe blood collection device seen in Figure 1 of which a needle cover and associated needle (not shown) have been removed by first brittlely breaking the needle cover from a portion of the housing. Figure -3 is a perspective view of the blood collection device seen in Figure 2 showing a needle uncovered by the removal of the cover and a partially removed seal which covers and protects the inner portion of a barrel from the tube. vacuum to draw blood, in relation to the needle. Figure 4 is a perspective view of the device for drawing blood, showing the displacement of a lid, seen in its place in Figure 3, thisdisplacement allows one area of accommodationPreviously under the lid is distorted, this distortion results in retraction of the needle inside the housing. I Figure 5 is a perspective view widelyI 5 amplified from a medical needle having a portion of the! needle treated with a release mold. Figure 6 is an exploded side view of a device for drawing blood with some portions' segmented and other portions removed for your bestpresentation. Figure 7 is a side elevation of the needle / punch assembly which initially resides within the housing and is detachably attached to the cover. 1 Figure 8 is a top elevation view of the• 15 needle / punch assembly seen in Figure 7.; Figure 9 is a lower elevation view of theNeedle / punch assembly seen in Figure 7. Figure 10 is an exploded perspective view of a section of the needle / punch assembly seen in FIG.! 20 FIGS. 7-9 and a lamella valve which is used to restrict the regurgitant flow of the device. Figure 10A is a perspective view of a section of the needle / punch assembly showing a lamellated valve attached by molding it to the needle / punch assembly a| 25 through a maintenance hinge. IFigure 11 is an exploded view of theI device of Figure 6 with a first assembly step completed. ! Figure 12 is an exploded view of theis a device of Figure 7 with a second step of assembly, comprising the joining of an elastic tube, completed. Figure 13 is an exploded view of the device of Figure 7 with a third mounting step1 joining the elastic tube to the barrel part. (Note thata perspective of a fully assembled device isI | you can see in Figure 1). Figure 14 is a sectional view of a device used before retracting the needle. Figure 14A is a perspective view of aneedle / punch assembly with portions removed to give more clarity to the presentation. Figure 15 is a side elevation view of| a stressed elastic tube between barrel punches and the needle / punch mounting parts. Figure 16 is an elevational view of an alternative embodiment of a needle / punch assembly showing a first part which is molded and securely attached to the needle and a second part to the needle. which is molded to the needle but which is free to slidelongitudinally along the needle. IFigure 17 is an elevation view of the embodiment seen in Figure 16 with the slidable part moved to an attached position relative to the first, part. | 5 Figure 18 is a sectional view "longitudinal! of a portion of the device that shows the modality! needle / punch alternative in three different positions on the device. Figure 19 is a sectional view similar to the[LO section seen in Figure 18, but rotated 90 °. Figure 20 is a perspective view withSome of the parts removed to give clarity to theBarrel section associated with the embodiment seen in FIGS. 16 to 20. FIG. 21 is an exploded perspective view of the device comprising the embodiment1 needle / punch alternative. Figure 22 is a perspective view of an alternative embodiment of the invention showing an assembly ofI inserted IV IV catheter completely covered. Figure 23 is a longitudinal section of the assembly seen in Figure 22. Figure 24 is a perspective view of a 3 cc syringe which is currently commercially available.
Figure 25 is a perspective view of a retractable medical needle with a removed back cover for easy connection of a medical syringe, as is the syringe seen in Figure 24. Figures 26A-D are perspective views of the needle assembly medical retractable in various stages of use. Figure 27 is an enlarged lateral "elevated" section of the medical needle assembly, and Figure 28 is an elevated sectional view.side of the assembly seen in Figure 27, but "in some manner reduced in size having an extended medical needle I for use." Figure 29 is an exploded view of the retractable medical needle assembly. Figures 30A-C are perspective views of the molded parts of the elastic tube - Figure 31 is a perspective view of another device for drawing blood, showing the exterior of theI | Device hosting. ? 20 Figure 32 is a cross-sectional view of whatI along the lines F32 / F32 of the device for extracting blood as seen in Figure 31. Figure 33 is a cross-sectional view of theI device to draw blood from Figure- 31, in a state125 assembled and ready for use in a medical procedure. IFigure 33A is a side elevational view of the needle cover which has been removed in Figure 33. Figure 33B is a cross-sectional distance of a tensioned elastic tube. Figure 33C is a cross-sectional view of the tensioned elastic tube seen in Figure 33b, but I being distorted by a plastic section to obtain a more circular geometry seen in Figure 33B. Figure 34 is an exploded view of the parts seen in Figures 32 and 33. Figure 35 is a perspective view of the needle removal device "which is centered by extending an outer cover slidable away from the cover. Figure 36 is a perspective view of a catheter version of the needle removal device seen in Figure 35, with the outer cover slidable-disposed away from the medical needle to thereby center the device for automatic retraction of the needle Figure 37 is a cross-sectional view of the catheter version seen in Figure 36. Figure 38 is a cross-sectional view of a ii = positive needle removal disposed in a stateneedle or rest transportation and having another I i modality of an elastic tube distortion apparatus. | Figure 39 is a rear elevation view j of the needle removal device seen in Figure 38.
Figure 40 is a cross-sectional view of theHole removal device seen in Figure 38,; but arranged in a ready or mounted state where a medical needle is ready to be used. Figure 41 is a cross-sectional viewamplified along the lines 41-41 'of Figure 38, wherein a non-elongated elastic tube is disposed between a pair of tube distortion clips. Figure 42 is an enlarged cross-sectional view taken along lines 42-42 of theFigure 40 of the elastic tube and the clips seen in the Figure38, the tube is tensioned and the clips are provided along the tube to distort it from its round geometry. Figure 43 is a perspective view of an elastic tube with a propeller member wrapped around the120 tub-o. Figure 44 is a cross section of the plastic tube and the propeller member seen in Figure 43. Figure 45 is a perspective view of the tubeElastic of Figure 43 stressed and the propeller memberI\ also elongated to tightly close the elastic tube i] to distort the tube of its round geometry.; Figure 46 is a cross-sectional view of theElastic tube and the propeller member seen in Figure 45.
Figure 47 is a perspective view of a two part medical needle / punch apparatus. | Figure 48 is a view in upper elevation "of the, medical device / two-part punch seen in Figure 47,| with a separate part of the other party. LO Figure 49 is a perspective view of a; combination syringe and medical needle device. I Figure 50 is a cross-sectional view ofI a lateral elevation of the combination seen in the Figure'49. Figure 51 is a cross-sectional view of a side elevation or combination seen in Figure 49,| but with a rotation of 90 ° in relation to that view in! Figure 50. i Figure 52 is a sectional section viewcross section of an elastic tube and slot valveSeen in the cross section in Figures 50 and 51. j Figure 53 is a cross-sectional section ofAn elastic tube and a slotted valve seen in Figure i 52 with the elongated elastic tube to open the valveE5 slot.
Figure 54 is a cross-sectional view of the combination in an axial orientation as seen in Figure 51, but with a barrel section extending outwardly I from a piston section. I 5 Figure 55 is a cross-sectional view inI lateral elevation of the combination in the orientation seen in Figure 50, but with the device and the medical needle? extended to dispose the needle to be used and with a needle cover removed, i Figure 10a is a side elevation of the needle cover removed from the combination seen in FIG.
! Figure 55. Figure 56 is a cross-sectional view of a punch part of a medical needle device connected by means of a luer lock fitting to a part used as an extractor to extend the medical needle apparatus. Figure 57 is a cross-sectional segment of a vertically oriented medical needle / syringe apparatus combination having a filling orifice 20 disposed below a filling nozzle for the purpose of filling the syringe with a medical fluid. ---- Figure 58 is a hop-oriented segment of a cross section of the medical needle / eringa apparatus combination seen in Figure 57 with a plug placed in the filling orifice.
Figure 59 is an exploded view of the combination seen in Figure 49 with only the complete assembly step for attaching a medical needle to a punch. Figure 60 is a cross section of aside elevation similar to the combination seen in theFigure 50, but with a plug disposed in a protector i located on and protecting a pressure and distortion section of the piston section. Figure 60A is a cross-sectional view taken along lines 60A-60A in Figure 60. Figure 61 is a cross-sectional view of the side elevation of Figure 60, rotating the guard to join the plug inside the piston section. Figure 62 is a cross-sectional view of the central portion of a combination, similar to the combination seen in Figure 49, showing hooking and bolts used to limit the use of the combination forcing the needle cover far in in the piston part. Figure 63 is a perspective view of a safety apparatus for replacing needles for a medical phlebotomy procedure. Figure 64 is a cross-sectional view of the apparatus seen in Figure 63.
| Figure 65 is a perspective view of a lidI dorsal of the apparatus seen in Figure 63. -. Figure 66 is a perspective view of a front cover of the apparatus seen in Figure 63. Figure 67 is a front perspective view of a forward needle punch seen in cross section in Figure 64. Figure 67A is a view in "rear perspective of the forward needle punch seen in theFigure 67. Figure 67B is a front elevation view of the forward needle punch seen in Figure 67. Figure 67C is a rear elevation viewI of the forward needle punch seen in Figure 67. Figure 68 is a perspective view of a double ended needle of the type generally used in medical phlebotomy procedures and seen in Figure 64. I j Figure 69 is a perspective view of a! needle punch back seen in cross section of theFigure 64. Figure 70 is a perspective view of an elastic tube seen in Figure 64. Figure 71 is a perspective view of a shock absorber of the type generally used in needle devices.for phlebotomy and seen in Figure 64.
, Figure 72 is a front perspective view of! a combination comprising the medical needle seen in theFigure 68 attached to the needle punch back seen in theFigure 69. 5 5 Figure 72A is a rear perspective view of the combination seen in Figure 72. Figure 72B is a rear elevation view of the combination seen in Figure 72. i Figure 72C is a view in rear elevationof the combination seen in Figure 72. j Figure 73 is a front perspective view i of a shield which protects a posterior portion of the medical needle seen in Figure 68. i Figure 73A is a perspective view of the first embodiment of the invention. .5 posterior of the protector seen in Figure 73. Figure 74 is an exploded perspective of the components of the needle for the phlebotomy seen in the! Figure 64. i Figure 75 is a molded perspective viewof a barrel for phlebotomy used with the medical needle device for phlebotomy. Figure 76 is a perspective view of the phlebotomy barrel seen in Figure 75 with a portion I of the barrel bent in a position for use.
Figure 77 is a cross-sectional view taken along lines 77-77 in Figure 76. Figure 78 is a perspective view of the apparatus of Figure 63 with the dorsal lid seen in Figure 65 removed to be list, an insertable portion of the safety needle apparatus for insertion into the barrel for subsequent use. Figure 79 is a perspective view of the insertable portion of the needle safety apparatus in aIT was after insertion into the barrel. Figure 80 is a cross-sectional view of the needle security apparatus disposed in the barrel. 1 Figure 81 is a perspective view of the| needle safety device arranged in the barrel with the 15 phlebotomy needle uncovered and ready for use. Figure 82 is a perspective view of the barrel. and the needle safety apparatus after the needle has been retracted into the safety container inside the. barrel. 20-_ - Figure 83 is a cross-sectional view taken along lines 83-83 of Figure 82. Figure 84 is a perspective view of the needle safety apparatus with both end of the needle contained and protected for safe disposal.
Figure 85 is a perspective view comprising a mode of a rear water punch which includes a lock feature which prevents forward movement of a liner (not shown). Figure 86 is a cross-sectional view of the rear needle punch seen in Figure 85. Figure 87 is a cross-sectional view of an oil canning mode of a forward punch with an oil canning disposed of wayWHAT a portion of the needle extends forward of the punch. Figure 88 is a cross-sectional view of the forward punch embodiment of Figure 87, but with an oil canning arranged in a convex mode of suchso that the needle is disposed towards the back of the punch. Figure 89 is a cross-sectional view ofA segment of a front punch comprising a stopper and orifice filler to prevent the forward-facing needle from traveling after or moving after theretraction of the needle. j Figure 90 is a cross-sectional view of the. segment of Figure 89 after the retraction of | needle. Figure 91 is a cross-sectional view of an extendable medical catheter apparatus.
Figure 92 is a perspective view of an elongated cylinder which forms a backward portion of theI catheter apparatus of Figure 91. I i Figure 93 is a perspective view of aforwardly disposed needle cap of the extendable medical catheter apparatus of Figure 91. Figure 94 is a perspective view of a needle punch of the catheter apparatus seen in Figure 91.
Figure 95 is a perspective view of acombination of sections of the cover of Figure 93 and the, punch of Figure 94. ', Figure 96 is a cross-sectional view of the| catheter apparatus of Figure 91 comprising a needle,| a catheter and an extended needle cover for use. ? l5 Figure 97 is a perspective view of a1 medical needle device for autonomous phlebotomy containing a barrel and a needle safety deviceI medical as an integral unit. I; Figure 98 is a cross-sectional view of thedevice of Figure 97.! Figure 99 is a cross-sectional view of the1 device of Figure 97 with the medical needle extended andThe cover removed and ready to be used.
Figure 100 is a sectional view of a rear needle puncture of the device seen in the Figure97. Figure 101 is a sectional view of a central portion of the forward punch showing an asymmetric pipe connection mode, which causes the retracted needle to retract so that the needle re-enters the path hole. in the punch forward. Figure 102 is an exploded perspective view of a forward needle punch assembly, comprising a metal needle retainer. Figure 103 is a side elevation view of a portion of the forward needle punch assembly ofFigure 102 with an inserted needle, the retainer mounted to the rest of the punch and the proximal portions of the punch are seen in cross section for better presentation of those portions of this forward needle punch compared to the punch seen in the previous figures . In this description, unless reference is made to a specific object, the close term is used to indicate the segment of a device normally closer to the patient when it is being used. In a similar way, the term distal refers to "the other extreme (far from the patient).illustrated in the figures numbered above, wherein similar numbers are used to designate similar parts therethrough. In some cases, parts that have similar shapes and functions to the aforementioned parties are numbered with prime numbers of the parties cited above. Different embodiments of the invention can be applied through the general field. of phlebotomy (blood sample), syringes, catheters and butterfly devices. The Modalities of Phlebotomy (blood sample) | ! Reference is now made to Figure 1, where; observe an embodiment according to the invention of a device for drawing blood 10. As seen in t Figure 1, the device 10 comprises a barrel sectionL5 20 and a needle container section 30. In a fully assembled device, the section 20 securely attaches to the section 30 along the circular line 32 forI provide protection of the device content from environmental damage and pollution. The "barrel" section 20 comprises a flat seal 40 i and a pair of left or right lugs or parts of the handle, i designated 50 and 60, respectively, and a hollow barrel 70. The flat seal 40 is adhesively bonded to the section from barrel, 20 within an area of the plane defined by the continuous line72 in such a way that the hollow barrel 70 is maintained in aSterile condition before use. To use the device 10, the seal 40 is manually removed. Of course, a different type of stamp can be used, such as a pressurized part, which can be molded as a captive-fixed part of the section 20. No part is shown under pressure, but the production of the parts is well known in the art. A more detailed description of the internal parts of the barrel 70 is provided hereinafter. The section of the needle container 30 comprises an elongated tube 80, a cover 90, a proximal plate facing the front face 100 and an extractor ring 110. The extractor ring 110 is separable from the front face plate 100 in a segment fragilely releasable 112, which is described in more detail below. The related steps to use the deviceare seen in Figures 2-4. In Figure 2, the extractor ring 110 has been detached from the front face plate| 100. The detachment of segment 112 produces a collarroughly 114. As the pull ring 110 is advanced from the front face plate 100, a needle cover 120, which is firmly attached and integrally molded with the pull ring 110, appears through a hole created by the removal of the collar 114. Once Z5 the extractor ring 110 is fully extended, aIThe fork 130 is put into place by means of pressure in the hole "produced by the removal of the collar 114. TheI structure of the horsuilla 130 and its related parts areI described in greater detail later, i 5 The next step is to remove the seal 40 from the barrel section 20. Figure 3 illustrates the seal 40 in the process of being removed. In the next step, the extractor ring and the needle cover 120 are "removed" from the device 10. The needle cover 120 is preferablyattached to a punch 132 by means of a rotating connectorI removable, as it is by means of a type I bayonet connector. In any case, the connection connection between the punch 132 and the cover 120 must be able to support aI extraction force at least as big as a forceof delay imposed on the address imposed by a mechanism] of retraction which is energized by the extraction ofExtended cover 120 until clutch 130 is engaged.
I As seen in Figure 3, a hollow medical needle 140 is! uncovered upon removing the cover 120. "--- 20 As seen in Figure 4, a cover 90 comprises a maintenance hinge connection 142 to the elongated tube i. The lid 90 also comprises a hook retainer.144 which is normally engaged in a slot 146 'proximally disposed in the tube 80. Located in the lid 90,? 25 when arranged in the slot 146, is an areaI I deformable 148 of the tube 80. While the lid 90 is disposed and engaged within the groove 146, the area 148I is totally protected from any deformation. ThisI way, during a medical procedure of extraction ofblood, the cap 90 is hooked to the slot 146. Once the blood acquisition has been completed, there is a rotation of the cap 90 by single-digit action after which! the needle 140 can be retracted by pressing the area 148. The retraction places the needle 140 securely inside the[LO tube 80. The only access inside tube 80 and needle 140 is! a hole 150 in the punch 132, which essentially hasThe same diameter as the cross section diameter of theNeedle 140. In addition, as will be explained later, the needle 140 j is held securely away from the hole 150.
I 15 retraction mechanisms for the needle 140 are described in! 1 detail later. I Also, seen in Figure 4, is a cover toI | pressure 151 attached by a captive 152 to the handle 60. The cover151 is an alternative modality to seal 40. Cover 151has the advantage of not requiring a part of the cover forBe made separately from the barrel section 20. However, to provide assurance that the cover151 has not been previously opened to the procedure to which the device 10 is solely dedicated, an additional seal,as is a hot coating, on the edgesIexterior of cover 151 and related parts of handles 50 and 60 and tube 80 should be used. The manufacture of parts used by the captive is well known in the art. Reference is now made to Figure 6 wherein an exploded view of one embodiment of the device 10 comprises a needle-containing section 30, a part of| needle-punch 16O, a disc valve 170, an elastic tube180 and a barrel section 20. First, attention is fixedLO to the needle / punch part 160, which is shown extensively for more clarity of the details in the Figures7-9. I! The part 160 comprises a medical needle 140, aI anterior part 190 near the sharp end of the needleI-LS 140, a central part 192, and a "rear" part 194.
| Normally, unseen extensions of needle 140 through i of part 160 are indicated by double dotted lines 196I and 198 for clarity of needle extension 140Going through part 160. The previous part 190 p? comprises the fork 130, the punch 132, an annular groove! 200, an annular retainer 202, and a cone-shaped extension| 204, which comprises a part extending outwards206. The central portion 192 comprises a brittle bridge 208 and a support 210-- The rear portion 194 comprises a short arrow 212 and a tube punch -214. Part 160 ispreferably molded as a single part with end-to-end continuity between the parts 190, 192 and 194.
The back 160 is firmly and securely attached to the needle 140, while the front 190 onlyis slidably and otherwise freely attached to move along the needle 140 when the bridge 208 is brittle. TheBack 160 can be adhesively bonded by methods 1 that are well known in the art. The punch 132 comprises a releasable connector component 10 which may be in the form of a surface | woven 216 as seen in Figures 7-9. The fork 130 i comprises an inclined annular face 218 and a ring of! transverse engaging surface 220 distal and juxtaposed to face 218. Slot 200 is interposed between and contiguously with ring 220 and retainer 202. Function and, use of fork 130, slot 200 and retainer 202 they are I described in detail later. As best seen in Figure 7, an extension 204 protrudes distally from the retainer 202 via 20 of a side bar 222 to a bend 224 where the extension 204 makes an orthogonal fold to form a part extending outwardly and toward up 206. The bridge 208 is a narrow part in both transverse dimensions to govern the degree of pressure required by the upper bridge 208 of theextended part 204. One of the surprising aspects of the; instantaneous invention is the force that can be placed on the bridge 208 when pulled against a force i retaining memory elements used in the retracted needle 140 without breaking the bridge 208 away from the extension204. Clearly, if even a nominal torque is placed on the bridge 208 during a pull, the bridge 208 may break. Close tolerances should be maintained between the needle 140 and the front 190- to reduce and maintain the torque to a level which does not cause the bridgeÍ0 208 breaks while the needle 140 is being pulled1 forward. The method for achieving close tolerances i between the needle 140 and the anterior part 190 is explained further ahead. The bridge 208 is contiguous with a support 210-arrow 212 is moderately arranged around the needle140 and distally connected to support 210. The punch of the! tube 214, is connected to arrow 212, which provides a lamella valve holding basket 226, where aI one-way laminar valve can be placed and f-0 trapped by a tube mounted on punch 214. Basket 226! is best seen in Figure 10. Basket 226 comprises a! slit formed on one side with distal view 228 and one sideWith proximal view 230, the two sides are connected by a bottom plate 232 and two side members 234 and 236. iThe side 228 is a smooth flat face comprising a non-protruding rounded end 238 of the needle 140.
Also shown in Figure 10 is a lamella valve disk 240. The disk 240 is made of a resin materialmalleable synthetic which, under pressure, deforms to seal the end 238 of the needle 140 against the regurgitant flow when the downstream pressure of the needle140 is greater than the upstream pressure. This seal is very important to contain the blood inside the needle 140 0 in the retraction of the needle 140. To ensure a lowResistance to flow of needle 140, disc 240 comprises| a plurality of raised feet, which give space to the distal side of the disc valve 240 away from the side 230.
This spacing and several cuts, designated 242, 244, 246 5 and 248 at the distal end 250 and a rear portion 194 provide a low resistance path for the effluent flow of a patient. Care must be taken that the diameter, 1 designated by the arrows A, of the disk 240 is less than the sum of the distances indicated by the arrows B and C, but greater than B plus the diameter of the end of the needle 238 for'ensure that the regurgitant flow is always retained. However, disc 240 should not be inadvertently maintained in an open condition by an elongated tube onI 25 the punch 214.
Another embodiment of a one-way valve is seen in Figure 10A. If the punch 214 is made of a malleable and sufficiently elastic material, a lamella valve can be integrally molded at the enddistal of the punch. In the embodiment of Figure 10A, a thin flat bar 252 is integrally connected to the punch 214 '(which is otherwise similar to punch 214) by means of a maintenance hinge to stop the flow near through the needle 140 to one end 238 0 while allowing a distal effluent flow. In the modality seen in Figure 6, the forceRefractive is arranged by a tensioned tube. For this one1 purpose, the tube 180 is cut to a predetermined length1 allowing the displacement of a distal and proximal punchby a length of tube which has been tensioned when the device 10 is centered as the needle 140 isI! pulled out for use. The tube 180 comprises aProximal end 254 and distal end 256. Tube 180 may be made of any elastic material which iseffectively inert to the blood and which can provideA sufficient return force to retract a needle i | directly from the patient to a safe container. (An elastic force in the range of two to four pounds is recommended, although a return force has been found in the range ofone pound is adequate to remove the needle 140 from a patient and retract it towards the housing). The tube should preferably be capable of being elongated to at least a length of four times its resistance. However, the material currently preferred! is Krayton, a material of the -property of Shell Chemical-I Co., available from the GLS Corp., Thermoplastic Elasto ersDivision, 740 Industrial Drive, Cary, III. 60013-1962. It is observed that a needle one inch long should require a tube no longer than at least a half inch. The barrel section 20 comprises a plurality of internally arranged parts, generally designated 258.
The parts 258 comprise an elongated stabilizer key260, a distal tube punch 262, a mounting plate 264,a subsequent delivery needle 266, and a needle cover268. I The stabilizer key 260 is a rodI elongated, which is tensioned from the mounting plate 264 to beyond the retainer 202 when the device 10 is mountedand the tube 180 is relaxed. The punch 262 is formed from the needle 266 to provide an entry | perforated to a low pressure collection tube (not1 sample), as are the blood collection tubesVACUTAINER "(manufactured and distributed by Becton, Dickinsonand Company of Franklin Lakes, New Jersey.) As is standardin practice in apparatuses which are used to provide low pressure inlet of collecting tubes, a pierceable needle cover 268 is arranged to prevent leakage as the collection tubes arereplaced. Figures 6, 11, 12, 13 and 14 demonstrate the simplicity of the assembly of the device 10. Figure 6 is representative of the parts in a preassembled configuration.
Step one in the assembly comprises the insertion of the 0 valve disc 170 into a valve holding basket 226, as1 is seen in Figure 11. Step one is not required when a foil valve such as a valve formed by a pad 252 is an integral part of a tube punch 214 '. The connection of the tube 180 to the punch 214 (or the punch214 'in the case of the modality seen in Figure 10A) is1 seen in Figure 12. To ensure that the tube 180 is inWith secure form attached to the punch 214 (or 214 ') it is recommended that an adhesive be applied to a proximal portion of the punch 214 j (or 214'). Immediately before connecting the tube 180.
A suitable adhesive material should be used and care should be taken to ensure that no inappropriate blood reactive material is allowed to contact the areasWhere the blood can flow. An adhesive which has been; arranged as satisfactory in models of the invention the--5 which have been reduced to practice is the Super DuroGlue, manufactured and distributed by Loctite Corporation,Cleveland, Ohio 44128, commonly known as Super Glue,Although other adhesive materials known in the art can also be used within the scope of the invention.
All adhesives must be qualified to be compatible with the use in the medical application. The termination of the flow path of aFluid from a needle 140 is seen in Figure 13. The tube; 180 is connected at the far end! 256 to punch 262. AlAt the same time, the stabilizer key 260 is engaged in the latch slot 270 (see Fig. 14A) disposed in the annular retainer 202. The key 260 is formed to run laterally in and out of the slit 270 and fit snugly inside. of this when tube 180 isrelaxed (that is, during assembly). In this way, no undue torque or rotation stress is placed on the tangible bridge 208 during assembly. To provide a path for the 260 key by passing the! support 210, a material release plane 272 is formed aslong of the plane of the trip of the key 260 in the support 210.
| As a next step, the needle container section 30 is disposed on the assembled parts. The cover of1 needle 120 comprises a female connection segment 274 the, which is complementary to the male connector provided bythe punch 216. The cover 120 is preferably joined bya rotation section 30 relative to the punch 216, although the pressure connections, which can withstand withdrawal forces exerted by an elongated tube or a spring or the like, can also be used. As theneedle cover 120 is connected to punch 216, tube 80 of section 30 is engaged with mounting plate 264.1 tube 80 is securely attached to the mounting plate 264 by an adhesive or an ultrasonic welding process, which are well known in the plastics assembly art. In this way, a joint is provided to protect the needle140. As such, the sections 20 and 30 in combination provide a housing for the needle 140, which canBe used without additional packaging for transportation. Now attention is fixed to a face platefront 100 of the section 30. The face plate 100 comprisesA nearby surface 276 and a flat surfaceI substantially distal 278. Arranged on the surface 278There is an annular slot 280. Slot 280 completelyCirculate the area where the cover area 120 integrallyconnects to the plate 100 and the ring punch 282, theWhich one is integrated with the near end of the cover120. The punch 282 also integrally connects the ring110 to section 30. Slot 280 has a depth! enough on plate 100 to allow brittle separationand easy by a shot, turn or positive pull on the110 ring, while maintaining enough material to provide a sealed container and a strong and safe transport container. Products that have such stamps are commercially available. The frangibly detachable ring 110 and the "cover 120" of the section 30, as seen in Figure 2, causes the tube 180 to be tensioned between the separate punches 214 and262 as seen in Figure 15. The needle punch part 160 and, in particular, the safety slot 270 are removed 0 away from the key 260 by the same action. For this reason, it is recommended to make a slot 280 and a cover 120 of someAsymmetric way to minimize rotation during the, extension of the tube. One of the attributes of the material which allows the tube 180 to be used to store energy to retract the needle 140 and to act as a path for theFluid communication between needle 140 and needle 266, is! that the internal lumen of the tube remains patent whenStress The diameter of the lumen is reduced, but it does not close as the tube lengthens. When the ring 110 and the cover 120 are separated from the section 30 by the brittle plate 100 in the groove 280, an annular hole 284 is created in the plate 100. As seen in Figure 14, when the needle part / awlI 160 is pulled proximally, cover 120 and then the£ 5 fork 130 are pulled through hole 284. Thebiased annular surface 218 of the yoke 130 as seen best in Figures 7-9, comprise a diameter near theWhich is smaller than the diameter of the hole 284 and a distal diameter which is greater than the hole 284. However, the.5 distal diameter is such that the fork 130 passes through the1 hole 284, due to the "donation" of the material of which section 30 is made. Slot 200 has uh width whichAllows plate 100 to clutch inside it after1 the fork 130 is pulled through the hole 284. The proximal face of the retainer 202 has a diameter which is larger than| the hole 284 causing part 160 to be firmly: attached to the plate 100 when the fork 130 passes through! of the hole 284, as seen in Figure 14. Once the procedure 5 is completed involving the needles 140, and preferably while i i the needle 140 is still disposed in the blood vessel of the patient.! patient, the needle 140 is automatically retracted. HeThe retraction process involves (1) the protective hinge relocation cover 90 (as seen in Figure 4) and(2) applying the pressure in part 206 through area 148 of tube 80 to fragilely separate the anterior part 190 from the rear part 192 by breaking the bridge208 of the needle / punch part 160. The cap 90 is commonly released from its attachment to thetube 80 in groove 146 by inserting the thumb or a low finger(a portion of the cover 90 and opening it) The bridge 208: then it is broken by applying pressure, preferably between the thumb and the index finger, "in the direction of the arrows 284 and286. Fragile forces (ie, breaking forces) arethen applied throughout the area 148 to part 206 and the1 inner portion of the tube 80 to the support 210. Substantially, i all the other forces applied to the bridge 208 are those of tension caused by the longitudinal elongation of the tube 180. For this reason, the bridge 208 comprises a shapegeometric, which leads to the break when it is imposedI to the breaking forces, but able to withstand large amounts of tension. I! One of the most important reasons thatI substantially all the forces placed on the bridge208 during the extension and retraction mechanism, is aI close tolerance maintained between the needle 140 and the part, above 190. As mentioned previously, part 190 is made to be free of needle 140, so that I can slide on it. To maintain the narrow tolerance and to provide a cheap method for manufacturing the part 160, the needle / punch part 160 is preferably molded as a needle unit 140. The part 160 is preferably injection molded.; To allow the previous part 190 to bemolded on the needle 140, still slidably remaining ¡¡I free, a thin layer of mold release is applied to the needle 140 before molding. By applying a mold release layer 288 (see Figure 5) in an area where the anterior part 190 is molded, the anterior part 190remains only in slidable form attached to the needle140. Of course, at its distal end 290 (see Figure 5) of; the needle, the back part 194 is firm and securely joined by the molding process causing the needle 140 to be retracted when the tube 140, fixed to the rear part 194,its contraction is allowed. When the needle 140 is retracted to1 through fork 130 and punch 132, the only access1 of tube 80 is through hole 150, which has1 substantially the same diameter as the needle 140. Of course, once the needle 140 retracts, it remainsirretrievably within the tube 80 by a relaxed tube 180. Except for the needle 140, which is made of medical grade steel, the needle / punch part 160 isMade of a mouldable material having tensile strength, sufficient to withstand pressures of extraction ofI device 10, however, still easily separable in bridge i 208. As such, part 160 is preferably aSynthetic resin material such as polyurethane,| polypropylene or polyethylene. For a deviceI | experimental, the synthetic resin material used waspolyurethane "sold by Quik Cast distributed by TAPPlastics, Dublin, California 94568. However, many commercially available materials may be used within the scope of the invention. The barrel section 20 is also preferably made of synthetic resin material. The barrel section 20 is also preferably molded from a subsequent delivery needle 266. The same material which is used in barrels - commercially available for vacuum-based blood collection tubes (e.g., tubesVACUTAINER blood collectors ") may be used The needle cover 268 may be one of the same as are the commonly used VACUTAINERR blood collection tube barrel needle covers. isL5 preferably made by a single molding process. The molding material should be selected in such a way that! provide sufficient material strength to engage and1 keep the punch 132 connected through the extraction processes, sufficiently flexible when done asa thin membrane to allow sufficient distortion to break the bridge 208, and brittle to facilitate the opening j as in the slot 280. The material is preferably a synthetic resin material and can be 'polyethylene, although other materials that comply with theFlexibility, medical compatibility and sealing requirements can be used. 1 Reference is now made to Figures 16-20,! which are related to another embodiment of the invention.
This modality is similar to the modality seen in the Figures6-14 in general form and function, but do not depend on a fragile part to release and retract the needle. As seen in Figure 16, a needle / punch assembly 300 comprises two i parts, the designated front 302 and the back304, which are formed on needle 140. The parts! 302"and 304 can be molded into the needle 140 simultaneously, part 302 is preferably molded intoI a segment of the needle 140 to which a mold release'has been applied, as described above (see Figure i 15 5). I The front part 302 comprises a central body306 and a pair "of outwardly extending, individually designated arms 308, 310. Each arm 308, 310 is connected to the central body 306 by a biased hinge 312 andÍ20 314, respectively. The bias of hinge 312 and 314 is! preferably formed as part of the molding process. Such hinges are well known in the art (as a. example, the hinges on telephone connections). Each arm 308", 310 is -used to extend outward from thecentral body 306"a predetermined distance.
At an outer end 318, 320 of each arm 308, 310, respectively, is an engaging end projecting inwardly 322, 324. The central body 306 comprises a punch withconnection cover 132 ', which is similar in shape and function to the punch 132. A portion 316 is disposed remote from the punch 132', where the hinges 312 and 314 are joined. The rear portion 304 comprises a central body portion 326, a pair of wings-or skewed armsExtending outwards 328 and 330 and a tube punch 332.
! The wing 330 comprises a pole projecting inwardly i 334, the ends of which are on the fastening face 336.! opposite way, the wing 328 comprises a claw projectinginwards 338. The function and use of various parts of theI, front part 302 and back 304 are described in detail later. I! As mentioned above, the previous part302 is preferably molded in needle 140, but not 0 fixed thereto, except for the disposed natural gearMaterially covering the circumference of a portion ofthe needle. This allows rotation of the previous part| 302 to 90 ° and moved to a close proximity with the part! 'posterior 304 as seen in Figure 17.
The parts contained in this second modality -del! blood collection device 10 is best seen in theFigure 21. The second embodiment comprises a barrel section 20 ', tube 180, a needle / punch assembly 300 and aneedle container section 30. The barrel section 20 'is substantially the same as the barrel section 20, except for the replacement of a hook guide cylinder 340 integrally and disposed intermediate a portion anterior to the section of barrel.
IO barrel 20 'instead of a stabilizer key equally disposed within the barrel section 20-, 1 The hook guide cylinder 340 is best seen in theFigure 20. As seen in this, the barrel 20 'comprises the barrel 70, a closed front face substantially 342 of theL5 barrel 70, a distal needle punch 262 providing access to needle 266, and a hook guide cylinder 340.
The hook guide cylinder 340 is mediated, arranged inI face 342 and extends in an elongated fashion in line with needle 140 (not shown in Figure 20). The punch 262"is moderately disposed within the cylinder 340 along the same line, the cylinder 340 comprises a plurality of slits which provide relief for" the outwardly biased members of the parts 302 --- and "304; travel guide for assembly 300 and hook seals whichselectively they hold the mounting parts 300 in a proximal position while the needle is in use. A first slit 346, arranged to act as a guide, extends along the cylinder 340. In this embodiment, the device 10 is mounted to provide a portion of. wing 330 in slit 346. Arranged at its distal end, cylinder 340It comprises a second slit 348 out of place at 90 ° to the'slit 346 and has a length which is suitable for relievingthe compression of the wing 308, when the assembly 300 is disposed distally before use. In the same way, theCylinder 340 comprises a third slit 350 similar to slit 348 and juxtaposed 180 ° thereof, to provideI compression relief of wing 310. A fourth slit 352of the cylinder 340 is distally disposed at 180 ° of the| slit 346 and provides relief before the use of the1 compression of the wing 328. If an outwardly skewed material is used in the manufacture of the assembly 300 from which it does not take aAssembly after the time between assembly and use, it is not'20 necessary to provide the slits 348, 350 and 352. The cylinder 340 provides openings for four'slits at its proximal end 353, that is, slits 346,354, 356 and 358. As mentioned above, the slit346 provides a guide for mounting 300 when containing thewing 300. The longitudinal slits 354 and 356 arei respectively aligned with the slits 348 and 350. The slits 354 comprise a hook edge 360 for the end 318 of the flange 308, while the slit 356Comprises a hook edge 362 for wing end 320310. The slit 358 is aligned with the slit 352 and provides a hook edge 364 for the flange 328, as described in detail below. Each slot has a depth such that in combination with the hook portions of the wings 308, 310 and 328 occur "substantiallysimultaneously. The retention operation of the elements of assembly 300 is best seen in Figures 18 and 19. Each of Figures 18 and 19 are divided by dotted lines into three sections (A, B and C) to demonstrate the operations ofthe front 302 and the rear 304- of the assembly 300 at different positions along the length of the cylinder 340. It is seen that the wings 328 and 330 are arranged vertically in Figure 18. The wings 308 and 310 are vertically oriented in Figure 19, as partof the assembly 300 in Figure 19 there is a rotation of 90 ° relative to the parts in Figure 18. It is of particular importance to note that the flange 328, as seen in Figure 18A and 18C, extends in an upper the central body part 326 along the'25 line 366 to properly pivot up an arc! 368 to join an upper line 370. In addition, line 370 ends at the point of hook 372. From the hook point372, the shape of the wing 328 is further defined by a 374 inward progression line and a sharply connected line376, which, in combination, demarcate the claw 338. As seen in Figure 18A, the assembly 300 resides distally inside the cylinder 340 and the tube 80, and the wing 330 is free to move in the longitudinal direction of the needle 140 guided by slot 346. In the samemounting position 300, the wing 328 is "" arranged in a! relaxed or uncompressed state within the slit 352.
When the assembly 300 is pulled proximally to a mounted or useful state as seen in Figure 18B, the assembly 300! it passes through an intermediate state seen in Figure 18B.
As the assembly 300 moves proximally of the state seen in Figure 18A, the shape of the flange 328 is formed along the arcuate line 368 allowing the flange 328 to collapse, such that the line 370 of the wing 328 matches the cylindrical internal surface of cylinder 340.this way, "the rear 304 of the assembly 300 easily allows it to move through the cylinder 340- The compression of the flange 328, as seen in Figure 18B, causes the claw 338 to compressively retract the tube 180, thereby which -detains any flow of the liquid through it, while the wing 328 is between theI slits 352 and 358. The moveable assembly 300 proximally in the position seen in Figure 18C, allows the wing 328 to once again be aligned as it is biased to enter the slot 358. Once there, a hook formed at the pointhook 372 and along line 374 is caught by the1 edge 364, firmly retaining assembly 300 with the tube180 in the elongated condition. Referring now to Figure 19, the [device 10 has a rotation of 90 ° in the direction of theclock hands in view of the end of the needle 140 of the device - In Figure 19, the wings 308 and310 are vertically oriented. Each arm 308, 310 resides in an uncompressed state in the slits 348 and 350, i | respectively. The arm 308 comprises a surfacearched 378, similar to the arched surface of wing 328 aI along the line 368, which provides an easy release of the slit 348. The arm 320 comprises a similar surface 380 for easy release of the slit 350- "-" 20 As the assembly 300"" pulls proximally from the state seen in Figure 19A to the state seen in theFigure 19B, arms 308 and 310 are "compressed in. Each arm 308 and 310 comprise a hook foot, respectively designated 382 and 384, which engages and takesa distal annular surface 386 of the central body 326.
I Ithis way, the front part 302 is releasably attached to the rear part 304, while the assembly 300 is pulled forward to a centering position. In its closest position, arms 308 and 310 are biased outwardly to slots 354 and 356 respectively. In this position, foot 382 and 384 are engaged against edges 360-and 362 to form a permanent latch between these . It is noted that the outward bias of the arms 308 and 310 release the socket 382 and 384 against the surface 386, whereby the toe of the rear 304 is released by the front 302. When the The rear outlet 304 is thus released, the needle 140 is released from the proximal container in the tube 80 when the rear part 3Q4 is activated to a releasable state to be -distallly-displaced in contraction of the tube 180. Referring once again to Figure 18C, the rear portion 304 is released from the centered state by depressing the area 148 in the direction of the arrow 388. Such depression forces the wing 328 to move inwardly until the wing portion 328 along the line 374 and the hook point 372 stick the edge 364- The contraction of the elastic tube 180 retracts the "back 304 and the needle 140, to which the back part is attached securely, to the distal section of tube 80 seen in Figure 18A The previous part 30 -, remains proximal in the tube 80 to effectively connect the hole formed by the removal of the punch 282 and the collar 114. It is noted that the anterior portion 302 comprises a woven punch 132 ', similar to the punch 132. = ~With reference now to Figure 21, showing a: exploded view of the parts which are included in the alternative embodiment seen in Figures 16-20. "Parts of the alternative embodiment comprise the barrel section 20 ', the tube 180, the needle / punch assembly. 300 and the 10 needle container section 30. The assembly of the parts seen in Figure 21 to form a complete needle retraction device', which is functionally equivalent to device 10, involves the following steps: 1. Tube 180 is attached to punch 332; 2. By biasing the wings 308, 310 and 328 inwardly and running the assembly within the cylinder 340 to engage it with the slits 348, 350 and 352, respectively; 3. Joining the tube 180 to the punch 262. It is noted that access to the punch 262 is disposed through the slit 346; 4. The section 30 is displaced laterally so that the tissue connecting segment 274 of the needle cover 12J- engages the punch 132 ';. the rotational servo 30 joins the pin 132 'with the needle cover 120 (the assembly 300 is restrained from rotating e-jidc to which the wing 330 is disposed in the slit 346, a bcs during the assembly and method of centering 6. "section 30 to section 20 ', preferably by applying adhesives or byUltrasonic welding to form a package ermétic --- sealed in the sgur 14- -I 1C A Catheter Modality Reference is now made to Figures 22 and 23 illustrating an insertion catheter 400, which is another modality of the invention. Jn closed transportable package of apparatus 400 can be seen in Figure 22.
On the outside, it can be seen that the apparatus 400 comprises an extractor ring 110 '-mido and integrated with the front face plate 100', which is similar to the face 100. The plate layer 10C is integrated with a tube 50 ', the cuai is also similar in shape and function to the tube 80. The plateface 100 'also comprises a fragile annular segment 112', the fourth allowing the ring 110 '"and ur-a collar portion 114' to the plate 100 'to be fragilely separated from the plate 100' when the needle assembly is pulled proximally from the tube 80 'for use.
The tuhe 80 'comprises a cap 90' similar to the function 9 / to the cover 9C, which is releasably attached to the groove 146 'and an opposite end --- nested to a maintenance hinge 142' to the tube 80 '. The tube 80 'is fully elongate 5 to contain a needle 140' used in the insertion of the catheter and a needle removal mechanism 402, which is seen in Figure 23. At its distal end, the tube 80 'comprises '- a section increases annular 434, which acts as ------- handleLC during the procedure of pulling the needle. In addition, the apparatus 400 comprises a distal piaca 406- ^ which securely attaches to the distal end! 408 of the tube 80 'for sealing and sealing the needle 140' and the extraction mechanism 402 center of the tube 80 '. L5 The extraction mechanism 402 comprises a water portion; a / puncture 160 ', which is similar to part 160 in form and function. The basic shapes in which part 160 'moves away from the shape of part 160 are in the distal and proximal segments of part 1-6C.
ZZ -Proximate-entity, part 160 'comprises a secondary connection 412 face transcutaneous catheter 410. - Such catheters and catheter connections are well known in the art of transcatheter catheters. Also, acute uses with transcutaneous catheters are easily23 available, A common source is 3ecton7 Dickinson andempaty from Franklin Lai-es, New Jersey 07417-1863. a current source for catheters is Abbct Hospitals, Inc., North Chicago, 111. 60C54. The material from which the BC tube and the piaca 406 are made is similar to the materials described above for tube 80. 7 The distal part! 160 'comprises a connection 414- by which an energy storage component 416 is attached to the punch portion 416 of the part 160'. As can be seen in Figure 23, part 160 'comprises a catheter needle 140', an anterior portion -.19C proximate-to the piercing end of needle 140 ', a central part 192', and a posterior part 194 ' . With the exceptions of the distal and proximal connections of the mechanisms 402, the parts 190 ', 192' and 194 'are substantially the same in form and function to the parts 190, 192 and 194. A part? E bridge 208' and a portion extending upwardly 206 ', each being respectively similar in shape and function to the bridge 208 and the part 206, are similarly disposed toward the compressible access perimeter to an oppressive area 143' of the tube 60 '. Marked differently, although within the scope of the invention, there is a storage component for return energy 416. Component 416 comprises a plurality of piston head portions 420, 422 and 424, which communicate with an internal tube 426 90 'foreffectively; = iar and retain vacuum as the mecs-ti-smo moves proximally. The empty content in the 80 'provides the force which retracts the water to 140' when the bridge 208 is fragilely broken. To providea suitable retraction force, the parts 420, 422 and 424 stop creating a sufficient differential force to withstand forces of aesthetic adhesion on both sides of the needle and other retraction mechanisms. For the device 400 to have a universally universal use, an atmospheric pressureThe minimum of ten pounds per square inch is assumed, for example, for a minimum pressure of four pounds obtained from an atmospheric pressure of ten pounds per square inch, each part 420, 422 and 424 must have a minimum area of four. tenths of an inch square.the parts 420, 422 and 424 are essentially flatCircular, the diameter should be a minimum of 0.36 inches i (0.9 centimeters). However, for some retraction pistons, only in the order of two pounds of force have been required. In such cases, in which the_ requirement ofThe force is lower, a reduction arranged in the size of the parts 420, 422 and 424 is possible. The parts 420, 422 and -424 are securely attached to a moderately disposed piston punch 428, which is in the same manner attached to the mechanism 416 through the medium.of ma back 194 '. As indicated by the lines43C, the needle 140 'co uni-ca with ßl punch 42B by (means part 194'.? punch 425 is a hollow container and which is completely sealed, except for a plug of 1 communication? e gas 432 arranged next to part 424.
? "The plug 432 is made of a hydrophobic material, which allows the passage of gas (air), perc slows the flow of water-based liquids (with blood). The preferred material is ultra-high molecular weight polystyrene, -rué has a particle size in The order of1 10 10 icrones, which is a material available from POR? XI Technologies, 500 Bohann.on Road, Fairburn, GA 30213. The stopper| 432 is securely attached to the punch 428 to provide a path for the gas to relieve pressure as the blood communicates within the punch 428 throughthe needle 140 '. The punch 428 is already made of transparent or translucent materials through which it can beI see the blood. I.e this way, when providing the pathI of the needle 140 'inside the punch 428 and allow the air I 20 to escape from the pin 428, as the affluent blood arrives, the punch 425 provides a "retrospect" visuallyDeterminable per blood, which is commonly used for1 securing the entrance of the needle 140 'in a blood vessel- To use the apparatus 400, a ring 110' and an i 25"collar 114 'are fragilely separated from the plate 100'.needle cover 120 ', needle 140' and catheter 410 are pulled-out of tube 80 ', until mechanism 402 is firmly fixed to plate 100'- By this action, vacuum ----- created in the portion of the tube 80 'the cuai is distal to the part 420. The cover 120' is removed and the needle 140 '- and the catheter 410 are subsequently inserted - inserted inside. "of the patient following the good practices When the needle 140 'enters a blood vessel, the blood is communicated to the punch 423 through a "" retrospection "of the blood indicating the attending specialist that it has entered the vessel. At this point, the lid 90 'is raised to provide access to the area 148'. A portion of the area 148 '1 is oppressed to fragilely break the bridge 208 ', which releases the rear portion 194' of the mechanism 402 to beretracted by the force stored by means of the partsI 420, 422 and 424 in cooperation with tube 80 '. the needle "140" is therefore extracted, the only trajectory through iaWhich blood can be communicated by removing the needle 140 ',It is inside tube 80 '. This limitation in the extraction ofthe needle is a definite advantage over non-needle systems, = uto-retractable currently in use. Lower appropriately controlled conditions, catheter 410 is removed for the application of other medical devices.
Vr-a -Legality? E Syringe With reference now to Figures 24 and 25 where - to sr? R.ga ce 3 cc standard, --- om-ercial-r-dispos available 500 is shown in Figure 24 and a self-retractable medical needle assembly 510 is seen in Figure 25. The syringe 500 comprises a male luer fit 512 and a female iuer safety socket 514 disposed at one end of the elongated syringe barrel 516. The male 512 fit. It comprises a flow lumen 318, through which the fluid is communicated between the barrel 516 and a medical needle. The assembly 510 comprises a housing 520, a female luer lock connector 522 and a needle cover 524 extending outwardly from the housing 520 toward an end of the housing 520, which is spaced apart from the housing 520. of the luer lock connector 522. The cover 524 comprises a fluffed section 526 and an elongate end 528, which, in combination, provides a section which can be easily taken between the thumb and the index finger to pull the cover 524 of the housing 520. The steps involved in using assembly 10 are best seen in Figures 26A-D. A "stock" mode of assembly 510, with a rear portion covered by a cover 330, is seen in Figure 26A. "cap 330 preferably comprises a male luer lock wire similar to the female luer lock 514, to ensurethe use of the insurance connector luer_522? the housing 52C. In the transport, the cover 330 is also fragilely connected to the ale; 510, preferably by a connection process known in the art of molding plastics eats the heat buildup. In the same way, the eu-overa 524 is preferably and brittlely connected to the alloy 520 per heat accumulation. After the assembly 510 is connected to a syringe, partly seen by a section of the secure female luer connector 514, in Figure 26B, the cover 524 and the medical needle 540 (seen in Figure 2STC) are jalaia housing 510. Cover 524 is preferably brittle separate from housing 510 to allow cover 524 and needle 540 to extend. Cerno can be seen in Figure 26C, cover 524 is removed (preferably by a turn of a quarter turn) to expose medical needle 540. Also exposed is a first punch 550 which is transported to a 540 needle, but which is slidably free of the needle 540 when the needle 54; it retracts After a medical procedure, a medical needle 540 retracts, releasing a latch hook 'described in detail below), back into the housing 510-? Lumen 552, through which the needle 540 retraceably travels. , is the only opening, which remainsat the front end of the housing 510 when the water is retracted; to. After retraction, medical needle 540 is complete and securely contained within housing 510, thereby allowing simple procedures for safe disposal. With reference now to Figure 27 in which a syringe needle mounting embodiment 510 is seen in cross section, widely amplified. A syringe 500 is attached to a mount 510 by means of a female Luer lock connector 514. As described above, the female connector 522 is woven within the luer lock connector 514 to firmly but releasably attach the assembly 510 to the syringe 500. In addition to the cover 524 and the housing 520, the assembly 510 comprises a medical needle punch assembly 560, an elastic tube member 370 and an inner housing member 580. As described so far, the cover 524 comprises a thin section 526, which provides for the cover 524 to easily adhere to pull it and the needle 540 of the housing 520. The cover 524 also comprises an elongated hollow barrel section 582 in which the needle 540 is enclosed with protection Before its use. At an end 584 the cuai is distally disposed of the thin section 326, the cover 524It comprises a coupler 334 which is releasably secured to the punch 550. Such a fixture is preferably "woven." The housing 520 comprises a barrel with elongated cylindrical shape 586, and a hole 5-88 disposed a the outlet of the needle and at the inlet end 590 of the barrel 586. At one end 592, which is distal from the end 590, the barrel 586 comprises a transverse-round termination arranged near the exit end and re-entry 590 is a deformable area 148 '(similar in shape and function to the area 148, described hitherto) To achieve the function of the area 148', the housing 520, the cover 524 and the inner housing member 580 are made of a moldable plastic material since it is not seen in Figures 25-28, one should understand that a lid assigned to the lid 90 can be added to the shelter 520 to protect the area 148 'so that it is not inadvertently pressed prematurely. mount d The medical needle punch 360 comprises a medical needle 540, an anterior punch part 302 'and a posterior punch part 304'. Punch parts 302 'and 304' are similar in shape and function to parts 302 and 304, respectively, and are therefore indicated by premiums of the aforementioned punch parts. Parts 302 'and 304' essentially comprise all the features of parts 302 and 304. The biggest differencebetween each part 302, 304 and 302 ', 304', respectively, is the size. The parts 302 'and 304' are much smaller than the respective portions 302 and 304 to allow the size of the assembly 510 to be compacted to a diameter which is consistent with the radial diameter of the connector 514- the assembly 560 also comprises an elastic tube punch 594 disposed at one end of the needle 540 distal of its dotted end Similar to the parts 302 and 304, the parts 302 'and 304' are preferably made of a resilient synthetic resin material. of using separate parts, such as the parts 302 ', 304' a medical needle punch assembly 560 may comprise a single punch similar to the needle / punch part 160 or 160 '. In such a case, the punch similar to the part needle / punch 160 or 160 'is fragilely separated to retract the needle 540 into the housing 520. The inner housing member 580 is similar in shape and function to the cylinder 340 relative to the proportion of forward bolts for the parts 302 'and 304' The inner housing member 580 comprises bolts for the wings of the parts 302 'and 304' and the back plate 396. As can be seen in Figure 29, the back plate 596 comprises an annular groove or cavity. 598, which forms "a closure for a circular projection 604 of the elastic tube 570. A latch edge 360 ', similar to the edge 360, which formsa cylinder lock 3-40, forms a bolt for an aia of part 302 '. A similar lock is on the other side of the inner housing 580, but is not shown in Figure 29. Referring now to Figures 27-30A-C; wherein the elastic tube member 570 can be "seen" elastic tube member 570 may be made of medical grade latex, silicone rubber or other elastic tubular material which is reasonably inert and does not contaminate the blood. In such materials, the elastic tube member 570 can be manufactured by molding, extrusion or immersion methods which are well known in the manufacture of elastic parts. As seen in Figure 27, the tube member 570 comprises an inner surface 600 - which conformably but relatively loosely fits over the male luer fit 512. It is preferable for the fit 512 to somehow fit snugly to surface 600 to allow room for fluid to be drawn inward through needle 540 when retraction of the needle is carried out. However, it should be especially noted that the surface 600 should be constrained to a tight seal in the adjustment 512 when the needle 540 is extended outwardly from the housing 520 as seen in Figure 28. This constriction secures a tight seal between the 570 tube and the 512 adjustment when iAssembly 510 is in use. Pulling the punch assembly of the medical needle 560 out of the housing 520, which results in elongation of the tube 570 in the seal fitting 512, is best seen in Figure 28. At one end near the needle 540, the Tubes 570 comprise an interior surface 602 which is sized to fit snugly over the tube punch 594. In view of simplicity for manufacture, it is preferred to provide an adjustment which causes the tube 570 to adhere to the punch 594 , without adhesive. However, it is within the scope of the invention to adhesively secure the tube 570 to the punch 594 to ensure the total reliability of the connection. At one end of the tube 570 close to the surface 600, the tube 570 comprises an annular projection 604, better seen in Figures 30A-C. As seen in Figures 30A-C, the tube 570 comprises a generally frusto-conical shape, which is somewhat elongated within the region of the inner surface 602. While a frusto-conical shape is preferred, a long tubular shape may be used. of a substantially constant radius. However, if the tube 570 is made by dipping or molding, additional features may be incorporated which may include an O-shaped ring 606, seen in Figure_30A,arranged as an internally directed elevated feature which acts to closely match an adjustment 512 whereby it can clean the adjust 512 when it is uncoupled from the tube 570. Also, a "plurality of ribs 608, seen in Figure 3CC arranged at The length of the interior surface 600 causes a space to be removed when the tube 570 is tensioned and to be recreated when the tube 570 is allowed to re-compress to a state of rest while the needle 540 is retracted. The additional space creates a negative pressure which draws the fluid into the needle 540 as it retracts to minimize regurgitation of the fluid when the needle retraction occurs The projection 604 comprises an annular hook which holds the tube 570 in place in the slot 598 when the adjustment 512 is inserted into the assembly 510. Preferably, the projection 604 is adhesively fixed to the back plate 596 to allow the The adjustment 512 can be disconnected and removed without disassembling the tube 570 of the back plate 5961 As can be seen in Figure 29, the assembly 510 is directly adaptable to an automatic construction - the housing 520, the cover 524, the parts 302 ' 304 ', the inner housing 580 and the cap 530 are preferably all injection molded parts. The 570 tubeit is preferably produced in mass by extrusion, molding or immersion. The needle 540 is preferably made of medical grade needle, and punctured to a needle point by methods currently well known in the medical needle art. 5 Assembly 510 is designed to be automatically assembled. The first portions 302 'and 304' are slidably attached to the needle 540 by inserting the needle: 540 through the axial holes in each of the parts 302 'and 304'. Part 304 'is much better attached to the needle540 per one adhesive (preferably epoxy). The cover 524 is freely attached to the punch 550. The tube 570"is disposed through the dorsal plate 596 and the projection 604 is preferably in adhesive form attached to the slot 598. The inner surface 602 is disposed on the punch 594 Y,if necessary to ensure secure connection, attached to the e. The housing 520 is disposed in the inner housing 580 and the cover 524, such that the thin section 526 is disposed outside the end of the inlet and outlet 590. A wing of the part 304 'is aligned with the areadistersionable 148 '. The housing 520 and the rounded end 592 are juxtaposed against the back plate 596 and securely attached thereto, preferably by ultrasonic bonding. The cover 530 is releasably attached to the back plate 596 by a knitted connection. To provide the guaranteeof alteration, the cap 530 is preferably sealed byheat to the housing 520 and the housing 520 is heat sealed to the cover 524. Another Phlebotomy Mechall Another embodiment of phlebotomy of the invention is seen in Figure 31. The embodiment of Figure 32 comprises a 610 device which is similar in form and function to the device 10 seen in Figures 1-4. As seen in Figure 31, the device 610 comprises a barrel section 620 and a needle-holding section 630. In a fully assembled device, the section 620 securely attaches to the section 630 along the circular line 632 to provide protection of the contents of the device from environmental damage and pollution. As seen in Figures 32 and 33, the barrel section 620 and the needle container section 30 may preferably be molded as one part to reduce the number of molded parts. The barrel section 620 comprises a flat seal 40 and a pair of left or right lugs or parts ~ of the handle, designated 50 and 60 respectively, and a hollow barrel 70. The flat seal 40 is preferably in adhesive form attached to the barrel section 620 within a flat area defined by continuous line 72, such that the hollow barrel 70 is maintained in a sterile condition before use. To use the 610 device, the seal 40 is manually removed- Of course, a different type ofseal, as it is a pressure-seated part, which can be molded as a captive-attached part of section 620. The part placed under pressure is not shown in Figure 31, but the manufacture of such parts is well known in the art. technique. A more detailed description of the internal parts of the barrel 70 is provided hereinafter. The needle-holding section 630 comprises an elongated tube 130, a cap 690, a face plate facing the proximal front 700 and a needle cover 720 partially externally disposed before use. The needle cover 720 is detachable from the front face plate 700 by means of a frangibly peelable cylindrical segment 712 of the needle containing section 630, which is described in more detail below. The related steps for using the device 610 are similar to those described for the device 10 in Figures 2-4. However, the needle cover 720 is preferably attached to the cylindrical segment 712 by heat bonding or ultrasonic welding. Therefore, the needle cover 720 is torn off by breaking the heat-bonding or ultrasonic welding bond and pulling the needle cover 720 and its associated medical needles, generally numbered 140, out of the needle-containing section 630- A once the needle cover 720 and the medical needle 140 are fully extended, a hook is hookedin a bolt retaining the needle cover 720 and the medical needle 140 in position just before use. the structure for the examples of the bolt, a hook and the operation of other parts disposed within the water-containing section 630 are described in more detail below. As the device 10 the seal 40 is removed from the barrel section 620. In a next step, the needle cover 720 is removed from the device 610. The needle cover 720 is preferably attached to the punch 732 by a removable, rotatable coupler, as is by a bayonet connector or frictionally held or woven. In any case, the coupling connection between the punch 732 and the cover 720 must be able to withstand a pulling force of at least as great as a retarding force imposed in the opposite direction by a retraction mechanism which is energized by the cover extending by pull 720 until the aforementioned bolt is engaged with the hook. As can be seen in Figure 33, the hollow medical needle 140 is discovered upon removal of the cover 720. Similar to the cover 90, the cover 690 comprises a maintenance hinge connection 742 to the needle containment section 630. Different from the - lid 90, lid 690 does not comprise the retaining hook normally engaged in the slot, but is preferably molded to be in a skewed position in tube 80. However, lid 690,With lid 90, it is easily lifted from its biased position to allow access to the distorted section disposed below and protected by lid 690. In this way, during the medical procedure of blood extraction, lid £ 90 is provided with protection . Once the blood acquisition has been completed, the cap 690 is raised by single-digit operation after which the needle 140 can be retracted by pressing an area 778, which is made and positioned to act in the same manner that the area 148. The retraction places the needle 140 securely inside the tube 80. The only access within the tube 80 and the needle 140 is a hole 750 through which the cover of the needle 720 was removed to expose the needle 140. The retraction mechanisms for the device 610 are generally the same as those described for the device 10. However, there are some differences in internal mechanisms of the two devices which are described in detail below. It might be preferable to protect the area 778 by means of an increased edge (not shown) instead of by means of a £ 90 cap to minimize the training required by the user- In such a case, the raised edge should provide tactile feedback- prevent inadvertent depression of area 778.
Now attention is drawn to Figure 32, where the 610 device is observed to comprise a numberReduced parts compared to the number of parts shown for the device seen in Figures 16-21- The device 610 comprises a cylindrical part 752, which is molded as a single part and comprises the cylindrical portions 5 of the needle container section 630 and the barrel section 620. In addition, the device 610 comprises a dorsal mounting pin 754, which is similar in form and function to the mounting plate 264, except that there is no part which is equivalent to the key 260 in the piaca 754.
The device 610 also comprises a single punch 756 with; an elastic tube 180 and a front plate 758. Similar to the mounting plate 264, the mounting plate 754 comprises a damper 268 and a dorsal needle 266 for piercing a vacuum tube for blood collection. 15 Next to the elastic tube 180, the mounting plate 754 comprises a punch connection 760 for the connecting pin 754 to the tube 180. Circumferentially, the plate 754 comprises an outer edge 762, which has a size so that by compression it fits inside of the inner wall 764 ofthe barrel portion 620. Preferably, the inner wall 764 also comprises a plurality of raised beads or an enlarged inner ring 766 in which the outer edge 762 is "press-fitted" for a firm hold. However, the outer edge 762 can be maintained in its• 25 place by bonding an adhesive or ultrasonic welding,both of which are well known in the art - to join the plastic part with another. The punch 756 is used to interconnect a medical needle 140 to the tube 180 and to provide a tube distortion portion 768 and a wing attachment 770, which is "arranged to engage the lock 772 when the needle 14-0 extends. In addition, the punch 756 comprises a woven portion 773, which is proximate the pointed end of the needle and used to firmly, but releasably connect the cover of the needle 720. As described above, an adjustment of friction or a bayonet coupler or other equivalent connector may be used within the scope of the invention in place of the portion 773. Disposed distally of the punch 732, is a cylindrical shoulder 774, which fills a cylindrical hole 776 in the faceplate 758 through which the needle cover 720 and the needle 140 are pulled to use the needle 140-? The shoulder 774 should be sized to fit within the hole 776 to provide axial support for the needle 140. The punch 756 may or may not use a tube distortion part as part 768, within the scope of the invention. In this way, the hole through which the sheet 140 retracts for its secure containment within the tube 30 is the orifice 776. For this reason, the orifice 776It must be made small enough so that human limbs or other parts can not access it. It is also noted that the device 610- contains only five parts, which are preferably made by1 5 injection molding. It is also noted that by making the section 630 of the same internal diameter as required by the hole 776 for digital security, the device 610 can be made without face plate 758, thus reducing the number of injection molded parts toonly four. These parts are the needle cover 720, the cylindrical part 752, the plate 754, the punch 756 and the front lacquer 758. The only punch 756 provides the opportunity for this limited number of parts to exist. that fewer parts can be used in the construction of the device 610 by combining one or more of the five parts, however, based on current assembly and molding considerations related to the cost of the device, this number of parts is currently preferred for this mode 20 Now pay attention to the punch 756. Similar to the parts 302 and 302 ', the punch 756 comprises a wing hook 770, which is designed to close a bolt 772. As previously described for previous embodiments, the cylindrical part 752 comprises a distorted section778, this distortion releases the hook "770 from bolt 772,to allow the elastic contraction of the tube 180 to retract the needle 140 in the needle-holding section 630. The punch 756 also comprises a tube distortion part 768 which is the key to providethe control of the regurgitant fluid without requiring a check valve. It is noted that when the punch 756 is pulled forward in the needle-holding section 630, an inclined ramp portion 780, preferably molded as a part of the front plate "768, causes a segmentincreased 782 of the distortion portion of the tube 768 so that a section of tube 180 is engaged and distorted. Reference is made to FIG. 33B where an undistorted tube is seen to have a substantially circular cross section. However, in a region or section of tube 180,'15 which is distorted by part 768 (segment 782), as seen in Figure 33C, the circular cross section is pressed on one side to reduce the internal cross sectional area of tube 180. This flattening produces a reduced volume of the tube 180 in the affected section.
To understand the need for such a reduction when the needle 140 is extended and the device 610 is mounted for retraction of the needle, one must understand the general dynamics of the changes in the contents of the inner tube as the tube is elongated between the'25 two punches to which the tube joins. Generally, if thefluid is captured as a bolus of continuous noise, between, but not in contact with, the connecting punches, and a mark is placed on each end of the bolus, as the tube is elongated, the ends of the fluid bolus are maintained substantially in the brand. However, if the fluid within the tube is increased to reside within the connection punches as well as the volume, for the containment of the fluid within the tube between the punches, it increases mainly due to the effects of the ends? connection in the punches. Such an increase in volume within the tube 180 in an elongated condition relative to the volume within the tube 180 in a relaxed condition causes an excess of fluid containment which is regurgitated or pumped the tube 180, usually through the needle 140 when the needle 140 retracts as tube 180 is allowed to contract. It has been found through experimental studies that the size of the punch is an important factor in controlling the amount of volume increase. However, a complete control can not be achieved by the simple design of the punch. Therefore, a distortion of the tube 180, when in an elongated condition, provides a significant method for reducing the internal volume of the elongated tube 180 to be less than the relaxed volume of the tube 180.
The fluid dynamics associated with breaking a rapidly retracted needle and the tube) can also contribute to fluid regurgitation. For this reason, it is recommended that the final retraction speed be maintained at the lowest possible 5 speed. It is for this purpose that a rearwardly arranged ramp 784 provides a frictional contact between the tube -180 and the part 68 at the end of the travel of the retraction of the needle. In this embodiment, it is preferred that the ramp 784 be molded with a part of the plate 754.
While it has been seen that this method of fluid control is applied in the embodiment seen in Figures 31-33c, one who is skilled in the art of fluid retraction and control systems may understand that this method or others methods disclosed so far can be applied to other 15 needle retraction modalities disclosed herein. The use of the 610 device is similar in functional steps to the devices described above. The needle 140 and the needle cover 720 are extended from the rest of the device 610 as seen in Figure 33, with the coverneedle removed as shown in Figure 33A. The needle is used in a medical procedure after which the protective lid (cover) 690 is raised, preferably by a finger or thumb, to provide access to the distorted section 78. The section 778 is distorted tocause the hook 770 to disengage from the 772 lock.
Released punch 735, needle 140, and shrink tube 180 are then fully retracted within the "container" section of needle 630 for safe retraction and storage of needle 140. Of course, so that -the device 610 can To compete with current needle devices, the assembly should be easily operable The simple linear assembly procedure for the device 610 is shown schematically in Figure 34. The needle 140 is securely attached to the punch 756 (preferably by epoxy), and the cover 720 is securely, but releasably attached to the punch 756 to protect the needle 140. The tube 180 is attached to the connection punches 760 and 786. Methods for securely securing the tube 180 are well known in the state The technique of connection of elastic tubes to plastic punches and varies from the use of connection by means of physical punch design alone to the use of adhesives and solvents. Since the tube material 180 and the punch 756 and the back plate have been selected, the appropriate type of connection method can be determined by current standard procedures and materials. The needle 140, in this manner clamped, and other joined parts are introduced into the barrel portion 620 until the needle cover 720 is exposed to a proximal end 788. The complete assembly of the device 610, thehole 776 and front plate 758 is fitted over needle cover 720 and firmly attached to part 620, preferably by heat ion, although other connection techniques such as mechanical interconnections and adhesive bonds can be used. Also, either the mechanical attachment of the dorsal plate 754 is preferred in its place (as is an internally disposed container ring 790 as can be seen in the barrel portion 620) or by heat bonding or ultrasonic welding. Another Catheter Mode Another catheter embodiment of the invention which employs a permanent latch and a separate hook release mechanism is seen in FIGS. 35-37. This construction is best applied to the needle retraction devices most closely related to the catheter and syringe modes due to the mounting constraints of the embodiments having large backs, such as the barrel portion of a blood collection device. The embodiment of Figures 35-37 is a device800 which comprises a backward extendable cover section 802 and a forward extendable needle cover 804. As can be seen in Figure 36, the cover section 802 extends rearwardly relative to the needle 140 '(as a example, a catheter needle and acatheter configuration), to allow the needle 140 'to be exposed for use. As can be seen in Figure 367 in addition to the cover section 802, and the needle cover 804, the device 800 comprises a pre-formed insertion handle section 8-06 and a 410 catheter. Section 806 It comprises a thin section 808, which provides for easy catheter insertion, and a distortionable section 810 by means of a width and a release - the latch is made to retract the needle 140. In cross section shown in Figure 37, section 800 is viewed to comprise an annular bolt 812 for permanently securing a corresponding annular hook 814 of the cover section 812. In this embodiment, a punch hook 81 &is secured against bolt 818 when The tube 180 is elongated - to provide a retraction force by the backward extension of the section 802. To retract the needle 140 ', secure containment within the combined internal volumes of the sec- Ions 802 and 806, the distorted section 810 is compressed to release the hook 816 of the bolt 818. Fluid Control for Phlebotomy and other Applications Referring now to Figures 38-42, where another apparatus and method is observed to constrict the internal volume of an elongated tube 180 relative to the elongated tube180. In this modality, a device 820 is observed in cross section. In most of the time, the device 820 is similar in shape and function to the device 610. Most of the differences include the elimination of ramps 780 and 784 in the device 820. Instead of the ramp 780, a cylindrical section inclined 622 is used instead of section 630 to perform the ramp function of ramp 780. The other important difference is the shape and function of forward punch 824. It is noted that punch 624 is the only punch surrounding the needle 140. The punch 824 comprises a segment 826 to which a needle cover 720 ', like the needle cover 720, is fastened for the purpose of protecting the needle 140 and pulling the needle 140 and punch 824 to extend the needle 140 for use. in the medical procedure. Similar to section 630, device 820 comprises a latch 828 and an associated hook 830 which engages to retain punch 824 and needle 140 in an extended state. The release of the hook 830 from the latch 824 is preferably caused by the distortion of an istorsionable portion 832 of the inclined cylindrical section 822. Distal to the segment 826, the punch "824 comprises a pair of the wings 834 and 836, which They form a clamp in the tube 180 when the punch 824 moves forward to extend the needle 140 for use.
Figures 41 - and 42, each wing portion 834 and 836 comprise a U-shaped gripper surface 838 and 8"40, respectively When tube 180 is in its relaxed position, clamp surfaces 838 and 840 otherwise they do not distort the circular cross section of the interposed tube 180. However, when the tube 180 is elongated by extension of the needle 140, the inclination of the cylindrical section 822 causes the wing portions 834 and 836 to be placed by means of the tweezers in the tube 180. The distortion reduces the cross section and therefore the internal volume of the elongate tube 180, thereby causing the tube 180 to have a smaller internal volume when it is elongated than when it is relaxed. Such a condition substantially eliminates any opportunity for regurgitation of the fluid when the needle 140 is retracted. Another apparatus and methods may be used within the scope of the invention to reduce the volume of the elongate tube 180 to be less than the relaxed tube 180. An example of Another method is described later. The opening between the surfaces of "820 and 840", when the needle 140 is extended, determines the amount of flattening of the tube 180 and, thus, the amount of volumetric reduction within it. exemplary showing the amount of volumetric reduction that is capable of being achieved is provided as follows:If D is the internal diameter of an irrigated tube, and d is the internal diameter of an elongated tube, at three times its normal length, then it is well known in the art that D 'is approximately equal to three times d2. In a flattened and elongated tube, the internal height of the tube can be represented by h, as seen in Figure 42. It is noted that the circumference! C) of the elongated tube is larger than the elongated tube area. p vecss d2 / 4. However, the cross-sectional area (A) of a flattened portion of the elongated tube is given by: A = -ph2 / 4 + (C - ph) h / 2 Equation 1 For the case where h = 0.46 mm and d is 0.92 mm, A is equal to 0.50 mur. The cross sectional area of an elongated but not flattened tube is 0.66 mm2, providing a reduction in the area of 0.16 m2 or a volume reduction of approximately 0.16 mmJ for each mm of tube that has been placed between the clamps. If the tube is placed between the clamps 19 mm, the exemplary reduction is approximately 3.0 mnr. Since it is important that the hook 830 aligns with the bolt 828 when the needle 140 is extended, the inclined cylindrical section 822 preferably comprises guides to ensure correct travel of the punch 824. Distantly, the device 820 is seen in FIGS. and 40 to understand a barrel section 842.? -n its enddorsal, section 842, comprises an opening 344 and a captive cover 846, which is used to provide protection for a back needle 266 described above. The cover 846 is similar in shape and function to the cover 151 described above. As best seen in Figure 39, the segment 822 comprises a pair of rail guides 348 and 850. A lower segment 852 of the wing 836 is arranged to travel between the rails 848 and 850 to maintain the hook 830 in a desired position with relation to bolt 828 and distortion -832. Another embodiment, which constrains the volume of a constricted tube 180 to be less than the volume of the tube 180 in a relaxed state is seen in Figures 43-46. Figures 43 and 44 show the tube 180 in a relaxed state. Figures 45 and 46 show the tube 180 in an elongated state. In simpler terms, the tube 130 is observed to be arranged within a helical sheath 854 to form a combination 856. As is well known in the art, if the sheath 854 is a relatively inelastic, extending sheath 854, approaching its resting length will cause the envelope 854 to become approximately a straight line. As the cross-sectional area of an elastic tube decreases by approximately the power of the number of the other lengths that the tube is stressed, one that is experienced in the art ofpropeller formation and elastic tube dynamics, understands that there is a critical helix point beyond which the internal volume of the helix decreases more rapidly at the time of extension than the internal volume of an interposed tube, such as a tube 180 The calculation of the critical point is relatively simple, as shown in the following example. The general equations of Cartesian coordinate for a helix are: x = - a eos? = A eos ns Equation 2 y = a sin? = A sin ns Equation 3 z = -1 Equation 4 where: • a is the radius of the propeller • • is the angle of rotation of the propeller along its long axis • s is the distance along the propeller • 1 is the distance along the long axis (z) of the propeller • n is the angular degree of change of? As a function of 1. An equation for the length of a segment along the helix is given by: - - ds = sqrt (dx2 + dy2 + dz2) Equation 5The differentiation between Equations 2, 3 and 4, with respect to y 1 and the substitution to Equation 5: ds = sqrt (a2n2 sentns ds ~ + a2n2 cos ^ ns "ds * + di2) Equation 6 Which reduces to: ds = sqrt (a: n2ds2 + di2) Equation 7 o: ds2 (1 - a2n2) = di2 Integrating on the length (S) of the helix and a distance (L), to which the helix is scattered, the relationship between ayn is given by: S = L / sqrt The value of n can be given as: n = 2p N / S Equation 9 where is the total number of turns in the long S of the helix, the substitution for n and taking the square root out on both sides of the equation and solving for the radius a:? = L / sqrt (l - a2 [2pN / S] 2 liquation 10 o: S2 = S2L2 / (S2 - a2 [2pN] 2 Equation 11 what produces: L2 =; s2- a2 [2pN] 2 Equation 12 Solving for a: a = Sqrt (S2- L2) / 2pN Equation 13-Resolving for N:N =? QrtlS ^ - L £) / 2pa Equation 14 Through the experiment, it has been found that the change in "" the internal volume of a tensioned tube between two known points along a length of the tube (not comprising the end tubes, where the tube is connected to a punch or the like), does not change substantially by the tensioning. Therefore, the following relations apply ^ V = 2pa2 1 'Equation 15 where: 1' is also the length of the section between two known points. It is observed that V is a constant: a is substantially equivalent to the sqrt (K / J ') where K is an easily derived constant- It has also been experimentally determined ^ ze the total internal volume (V) of an elastic tube does not vary due to at least the volumetric variations in two ends of a tube where the joints are made - by connection punches. This variation generally causes the volume of a tensioned tube to be greater than the volume of the same unstressed tube. This change in volume results in a regurgitation of fluid when the tube is used as a retraction mechanism and concurrently as a container. and transport path for a fluidreceived from a medical needle. It is for this reason that the use of a helical casing (such as the casing 354) is preferably used to reduce or restrict an increase in volume of the tensioned tube. An example of a method of design and use of a volume restriction propeller is given below: Using a plastic tube instead of the median needle to allow visual observation of the increase in volume due to tensioning of a tube elastic at a length of three times its length at rest, the increase; dV) in volume was observed as: dV '= 6.5 micrometers (μl) in an elastic tube having the following dimensions of its resting state: OD, " «P -, -, 0 = 3.18 -------- I. D.er. "Poso = 1.59 m Length, -, repos = 19.1 m Internal volume, -, -repos = 38 μl and having the following tensioned dimensions: Nominal O. D .-, -, canvas < .a = 1.83 mm Calculated 1.3. te-isionado - - 92 mm Length t-ns, ------ * = 57.2 --------- Internal volume t ---- s -.o - a.-o = 45 μl Nominal OD tube volume - < .n -.-- or ---- e--. = 150 μlAssuming that the compression reduction in the total tube volume (including the tube itself) would result in a reduction in the internal volume of substantially the same amount, a reduction in volume OD to approximately 143 μl, when the tube is Stressing requires the compression of the outside of the tube to an equivalent average diameter of approximately 1.78 mm. Because the number of turns of a propeller is not allowed to change when the propeller is lengthened from its resting state to a stressed state of the tube 180 in this application, Equation 14 (reproduced below) can be used to evaluate the long S and the number of turns N of the helix N = 3qrt (S2 - L2) / 2pa Equation 14 Taking the values for the rest of the state not stressed (r), Equation 14 becomes: N = Sqrt (S2 - L, 2) / 2pac Equation 14r Likewise, taking the values for the stressed state (s), Equation 14 becomes: N = Ssrt ( S2 - L., 2) / 2pa s Equation 14s y: Sqrt .S2 - Lr) / 2par = Sqrt (S2- L.2) / 2ita3 putting the square roots and multiplying crosswise: (S2 - hr2) (2pa3) 2 = (S2- L = 2) ( 2par) "solving for S: S = (Lr2a - L52a -) / (a, 2 - a-2) For the example given above: S = 68 m Evaluating N; number of turns) of equation 14s: N = 6.6 turns However, as seen in Figures 45 and 46, wrappers 354 do not completely enclose tube 180 and, therefore, tube 130 is periodically free to expand outward from the constriction of envelope 854 in the spaces between the constriction of the propeller. For this reason, the number of current rounds (N.) should be less than the predicted value of N, above. Even so, a more desired value of N-, can be achieved without improper experimentation by a person experienced in the fluid dynamics technique. It is well known in the extrusion technique? Elastic tube, to enclose one or more helically wound coils to support the material in the wall of the extruded tubes. Such enclosed coils are most often used to increase the strength of the tube to withstand the tube against inadvertent collapse or to withstand high pressures, a process similar to the extrusion process can be used to make a combination 856 by control suitable from a point and using the coil not to support the tube against acollapse, but to constrict the tube when it is stressed with a predetermined point of the propeller. Interlocked Punch Modality With reference to Figures 47 and 48, where another part of the punch 900 is observed. Except for the apparatus and method related to the hook portion 900 and releasing a portion of the portion 900 to retract a needle 140, the part 900 is similar in shape and function to the needle / punch part 160. The part 900 comprises two separable components, a forward component 902 and a posterior component 904. The forward component 902 comprises a section 906, which comprises a woven segment -908 and a cylindrical segment 910, which are similar in shape and function to the woven portion 776 and the cylindrical shoulder "774, respectively, attached to the segment 910 is the elongated cylindrical body 912, which comprises a pair of wing hooks 914 and 914. In Figure 47, only a portion of a wing hook, hook 914 ', is observed mostly removed for a better presentation of the rest of the forward component 90 2. A portion of the cylindrical segment 910 is removed to provide a "1" shaped surface 916, the purpose of which is described in detail below. In addition, component 902 comprises a postelongate 318, securely attached to the end 920 to 1 = superfiece 91 £, as seen in Figure 477? pest 918 comprises a hook member 922 prepor- ported in the extremity cher 924.? l member of hook 922 comprises a hook 926, which firmly, freely, joins the forward component 902 to the rearward component 904 along the surface 328"" of the 3-M header 3. The surface 928 is preferably orthogonal to the end portion 902. e of the needle 140. The component 904 comprises a main body section 93C, the four of which comprises a flattened portion 932, juxtaposed to an overlapped part of the post 918, as seen in Figure 47. The portion 932 is raised on a portion 934? and the "L" shaped surface 916, which is parallel to portion 932. In combination, post 913, portion 934 and apiary portion 932 define a substantially rectangular aperture 936, in which The 913 post can be bent to release the hook member 922? E surface 928. A-untrue is not shown, it should be understood that part 900 -is used within an elongated cylinder in a manner similar to that of "needle part / punch 160." In this manner, the - forward component 932 comprises a push button 933, which is lifted from the SIS pole to communicate with an internal surface of a membrane? istorsionable, is a diaphragm seen in Figure 32. Cen ia? lsterssion of the membrane and communication? e compression with the button 938, the post "916T over the opening 936 may cause the post 918 to bend towards the surface of the portion 934, so that the member? o hook 922 is released from the surface 928. The forward component 902 further comprises a stabilizing leg 940, which is designed to communicate on the inner surface of the cylinder. elongate mentioned above, which is in juxtaposition with the distortionable membrane to provide stability to the needle 140. Also, the component 902 comprises an arc-shaped part 942, which provides a support axially provided to the central component 904 while it is joins with the forward component 902. As in the case of the anterior part 190 seen in Figure 7, the forward component 902 is desirably attached to the needle 140. El- - rear component 904 further comprises a secure connection to needle 140-, a punch 944 to which an elastic tube 180 is attached. Proximal to the pointed end of the needle 140 is a convex conical surface 946, which is formed to mate with a concave conical surface 948 provided inward of the line 948 'in a cylindrical body 912 to provide a sterility barrierfor the needle 140 while the component 302 joins the component 904. The needle 40 extends for use when pulling the needle cover attached to the tissue segment 908 as previously described. In a state of rest before use, the component 904 is attached to the component 902 with a hook member 922 during the manufacture of the part 900. When the part 900 is driven forward to extend the needle 140 for use, the Hooks 914 and 914 'are caught in the locks (not shown) to secure and permanently join the component 902 in a forward position. At the end of the medical procedure when it is desired to retract the needle 140 for secure containment, the button 938 is obtained through a distorted membrane to bend the post -918 in the opening 936, the hook member and the edge 922 away from the surface 328, and thereby release the component 904 and the associated needle 140 for retraction by means of the force of the energy contained in the elastic tube 180. Similar to other punches and needle-related parts, both components 902 and 904 are preferably injection molded of synthetic resin materials. The materials, which are compatible for the requirements for components 302 and 904 are well known in the manufacturing technique of plinzches and needles.ae --oaa__aades er -? ngas stánaar and re-filled syringes stuck reference to Figure 49 is made in one moaaiiaad dohae ae according to the invention one ae eombiración apparatus ce medical needle / syringe is ebserra ICIO. As -lustra in Figure 49, combination 1010 eo prenae a rail syringe 1020 and 1030. The piston portion 1020 comprises a barrel member Tano alargeao hole 1040 and a distal end 1050, which is? Sp_esto transversai the body member 1040. preferably, the section 1060 at distal end 1050 has a larger curvature ae generalment radie the curvature ael míemete 1040 to permit barrel 1020 is easily- tomace and moved relative to part 1030. Preximalmente, one end 1062 provides an inlet and saline for 1064 of the piston 1030. - the dei part piston 1030 tamoién eemprenae _n aiargaao miemcre of hollow tube 1070, which has a size that fits without touching the inner member 1040 .
Extena accord ng radia_.mer.te-out member 1070 is surely attached an appendage 1072, which is arranged to be close, but not touching, the end Ee 1062. Preferably the apenaice 1072 comprises a prcximal face 1074, the which is generally sufficient to be treated with a prior art and an index for use in a syringe manipulation of a mania.
Extending distally? Ei Appen? Ice 1172 ai juxtaposed member 1040 are a pair of opposing members 1075 and 1C76, which will end abruptly in -tanges distended out 1078 and 1C50, respecti ely. The large of the members 1075 and 1076 depend on the length of the 1020 barrel and are adjusted to provide easy one-hand syringe handling.Such adjustments are well known in the syringe design technique. The handles 1073 and 1080 should "be sufficient to provide digital control using the index finger and the middle fingers. The proximal fin portion 1030 terminates in a cone of the hollow frushing cone 1082 to which a shield 1034 is attached. The purpose and function of guard 1084 is described in detail below. The cone of the nose 1082 comprises an axially provided hole 1086 through which a medical device squeegee 1090 is operative to extend the medical needle 1100, an example of which is seen in transverse form. in Figure 50. Referring to Figure 50, the medical needle device 1100 is seen to comprise a stretchable and flexible elastic component 1110, a punch element 1120 and a hollow medical needle 1140- while the component ~ 111! can be done as a number of separate parts, it is currently preferred that component 1110 comprises partsFully supported and formed which functionally work as a seal 1150, a normally closed valve 1160, an interface surface 1170"to a ventral surface, a rear portion of the rail 1020 and an elastic tube 1180. In the embodiment of Figures 49 and 50, valve 1160 is a foil valve, which is common with contemporary standard disposable syringes, member 1040 -comprises an opening 1064, a frustcconic shape comprising the valve 10 being conductive to seal passage 1150. In this case, the squeegee 1090 is a cover needle 1190, which physically and aseptically protects the needle 11 1140. to portion 1192 of the needle 1090, but unfavorably releases the seal 1150 of the member 1040. the cover 1190 is externally accessible through the hole 1086T In Figure 51, the device 1010 is observed in a cross section with rotation e 9-0 ° along? the long axis of the needle 1140. This rotation gives visibility to the opposite members 1075 and 1076. The rotation also gives visibility to the flat face 1194 of the lamella valve 1160. Referring now to FIGS. 50 and 51, in combination, the punch element 1120 is observed forcomprising a part of upper wing 1200, a part of aiabottom, 1202 and a pair side supports _ 1204 and 1-206. Each part of aia 12C0 and 1202 and each lateral support 1204 and 1206 are designed to run to the internal surface 1210 of the hollow elongate tube member 10.70, thereby providing support stability for the punch member 1120 and the needle apparatus. 1100. At a proximal end 1212, the punch element 1120 comprises a releasable connector such as tissue 1216 for a secure connection, per- misbly attached to the squeegee 1090. ------- an endpiece 1218, the element of punch 1120 comprises a punch member taking tube 1120 to attach to elastic tube 1180. While it may be necessary "for some materials used in the manufacture of tube 1130 to use an adhesive to hold punch member 1220, the proper joint has been achieved by physically lengthening the tube 1180 on a slightly larger punch member 1220. Figures 53, 54 and 55 illustrate apparatuses and methods for extending the needle device. dica 1100 to a position where the needle 1140 is disposed for use, and by which the valve 1160 is opened to allow deflowed flow through it, it can be seen. In Figure 55, the medical needle apparatus 1100, with the "medical needle" 1140 securely attached to the punch member 1120, extends to provide the needle 1140 in a position forits use in a medical procedure. The needle cover 1190 by which the medical needle apparatus 1100 was extended and then removed is shown in Figure 55A. The elastic tube 1180 is tensioned as the device 1100 is extended to store the retraction energy and to return the needle 1140 within the protective cover to the medical procedure. The elongation of the tube 1180 not only provides a flow path for the fluid to pass from and to the needle 1180, but also to store the retractor force for the device 1100, it also normally opens the closed valve 1160. As seen in FIG. Figure 52, the tube 1180 comprises junctions 1222 and 1224, which are integrally attached to the leaf valve 1160. The thickness of the joints 1220 and 1224 depend on the size of the inner diameter of the tube 1180 and the long and gro face 1194 (one opposite face 1194 '), of the lamella valve 1160. Such thickness can be determined without undue experimentation. As can be seen in Figure 53, the elongated tube 1130 decreases the diameter of the tube 1180 and distorts the lamella valve 1160 to the opposite sides of the faces 1194 and 1194 ', thereby opening the valve 1160. While there is Other devices and methods for achieving the opening of a normally closed valve as tube 1180 is stressed, this particular mode is preferred becausethe valve 1150 and the tube 1160 are made of a single part. In some cases, it may be convenient to select a medical needle determined by the situation and procedure-instead of having a needle given as "a predetermined element of a syringe." For this purpose, it can be used instead of providing a needle cover 1190, a pull 1190 'has a punch device connection -co or is that seen in the Example in Figure 56. A medical needle apparatus 1100' comprising a punch element 1120 'is used. , instead of the medical needle apparatus 1100 and the associated punch member 1120. The biggest difference is in the punch elements and particularly in the connection of the used jaws.In the case of the embodiment of Figure 56, the jala? or 1190 'comprises a female luer lock 1230, the punch member 1120' comprises a supplementary male luer lock 1232. The use of a luer fit provides an excellent seilo to close any path within a luer element. punch 1120 ', even if a compatible connector for adjusting a medical needle to an element? punch 1120' is provided after a medical needle device 1100 'has been extended for its use.
Generally, the device 1010 may already be used as a standard syringe or a pre-filled syringe. If the 1010 device is simpiemer.te used as a syringestandard; There is no need to provide access to fill the syringe, you put it through the medical needle. Also, in this case, there would be no need to provide a normally closed valve, such as ia-valve 1160. In any case, barrel 1020 and interface surface 1170 combine to define a space 1240 where the medical fluid Biological resides either before or after the medical procedure. Although not absolutely necessary, it is preferred that the barrel 1020 at the end 1050 comprises a generally frusteconical lower surface 1242, and that the inferred surface 1170 be juxtaposed with the inner surface 1242, having a complementary shape to facilitate the ejection of gas from space 1240. In the case of the application of the simple syringe, the surface 1242 is formed as an integral "continuous element forming part of the barrel 1020. To increase the filling space 1240 with a medical fluid, as is a liquid 1244, in Figure 57, an orifice is provided, such an orifice 1246 seen in Figures 57 and 38. A preferred method for filling the device 1010 is to orient the device 1010 vertically in the proxi- mal portion provided below. "Jna Flexible nozzle, such as a nozzle 1250 in Figure 57, is setably provided against the end1150 and the orifice 1246. As long as the surface il ": is in contact with the surface 1242, a connection to a vacuum is roofed through the nozzle 1250 to evacuate the gas from the space 1240. Subsequently, a connection is made with a vessel containing the liquid to be stored in the insulator 1010 through a path of low resistance via the nozzle 1250. The piston portion 1030 is moved downward to draw liquid 1244 center from the 1240 space. There is no other way exhaust that access through the hole 1246, for the liquid of the device 1010 until the valve 1160 is opened.Also a secondary seal can be provided, as it is by means of luer lock adjustment 1230 and 1232 to prevent leakage The liquid via evaporation Once the space 1240 is filled with a pre-ether volume of liquid 1244, a stopper is the plug 1260 seen in Figure 58) is used to seal the orifice. Step 1246 so that no more fluid flows. As one skilled in the art of filling and sealing medical pathways, it could be understood, this filling and sealing method is only one of many methods that can be isolated in the art. Other such methods may be used within the scope of this invention to safely and effectively fill and enlist a 1010 is useful for use as a pre-filled syringe.
With the exception of the extension and retraction of a medical needle device 1100 and 1100, the device 1010 is generally used as a standard medical syringe, requiring only a minimum of training-generally, the jaw 1090 is pulled out of the piston portion 1030 for extending the medical needle apparatus 110C or 1100 'for use As shown in Figure 55 (see also Figures 30, 51, 54, 59, "60 and 61), the puncture element 1120 (and 1120 ') a portion of aia 1200 which extends outward toward the inner surface 1210 is preferably formed. Preferably, the wing portion 1200 is slightly compressed within the piston portion 1030 to retain moderate pressure outwardly against the surface 121C. The wing portion 1200 comprises a distal rounded end 1270, especially formed to provide a contact and engagement. As the medical device 1100 (1100 ') is drawn out of the piston portion 1030 to a position where the medical 1141 is ready for use, the 1270 end is brought to contact the hook. with a protrusion 1230 on the inner surface 1210. The profusion 1280 acts as a latch for the end 1270. A thin oppositible section 1290 is in the area of the piston portion 1030 immediately next to the profusion 1280. The section 1290 is sufficiently thinnedto facilitate the oppression in a way and with forces ccisterister by pressing a key on a keyboard of memerana. With such oppression, the wing portion 1230 at the end 1270 (acting as a hook) is released by the profusion 120 (a bolt ,. The energy stored in the extended tube 1180 automatically causes the retraction of the 1100 mire needle apparatus. 1100 ') to remove the medical needle 1140 from within the hollow-bore 1070. Such a retracted needle 1140 is shown in Figures £ 0 and 61. The dangerous problems of the related slides With the recovery of uncovered medical needles, they have resulted in rules that are necessary and imposed, which prohibit the recovery of medical needles when special conditions or equipment make recovery safe, both for the prevention of care and for the patient. However, there are many reasons why it would be wise to recover medical needles so that they can be used a plurality of times, the reasons include the use of a medical needle to pre-fill a syringe through a medical syringe in the same place as the medical syringe. patient and then transporting the filled eringa for delivery to the patient, and also transferring the medication from the same syringe to the same patient after a procedure comprising passes inEr. Each one of the above cases, the medical needle must be retrieved provisionally before a subsequent use.For greater safety the medical needle must be retracted within its "safe, as it is inside" and the hollow part of the medical part. piston 1030 immediately after each use and, in fact, directly from the patient, as is possible with this novel invention. For greater safety, the medical needle should only be discovered immediately prior to its use and immediately covered after it. To safely provide and recover the needle, the retracted needle is retrieved by the following inventive method using the device 1010. In FIG. 60, a medical needle 1140 and a punch element 1120 are retracted to return the needle 1140 to its coated condition securely. As seen in FIG. 0A, the elongated tube member 1070 of the piston paste 103C comprises a plurality of ribs provided in the direction of 1292, 1294, 1296, and 1298. The outwardly extending portions of the punch element. 1120, the wing portions 1200 and 1202 and the side supports 1204 and 1206 are constrained from axial displacement by the ribs 1292, 1294, 1296 and 1293. The wing portions 1200 are eanstre-Eid ---- by the ribs 1292 and 1298, the wing part 1232 by the ribs1234 and 1296 and the lateral support 1204 for the ribs 1293 and 1296"and the lateral support 1206 for the ribs 1292 and 1234. The inward displacements of the ribs 1232, 1294, 1296 and 1298 are arranged to centrally constrict, but allow the linear displacement of the punch element 1120 and the needle cover 1190. In addition, the wing portions 1202 and 1204 and the side supports 1204 and 12C are commuted to restrict the needle 1140 in a substantially coaxial direction relative to the axis length of tube member 1370. With needle 1140, wing portions 1202 and 1204, and side supports 1204 and 1206 thus constricted, needle cover 1190 can be safely and effectively re-inserted through the hole 1086, with rotation to re-engage the connector 1216 and therefore be re-positioned to re-extend the needle 1140 for consecutive use.Two conditions necessary to effectively and safely recover the needle 114 0 with the needle cover 1190 are fulfilled as, first, the needle is securely covered while the act of recovery is achieved and, eesunao, the cover 1190 is biased away from contact with the needle 1140 to protect the sterility of the needle. 1140 needle during the recovery process. Of course, the parts of the needle cover 1130, which may come into contact with the needle 1140,When the 1193 cover is removed after the 1140 extended needle, it should be designed to "remain clean and contaminated while the 1190 is removed." One skilled in the roofing technique is an expert. Needle very well understands, there are procedures currently known in the art to handle and protect the needle covers removed in such circumstances. As it is also known in the art to use and remove medical needles, it is often convenient to remove the option of subsequent use of a medical needle after a medical procedure is completed. In these cases, where the needles are added to the syringe before retraction, a needle cover "1190 or - jaladcr 1190" can not be reconnected to the punch element.In this case, the needle is surely retained and It can not be reused, but in the case of a syringe designed for the re-use of a needle previously described, another element must be added to eradicate re-use options. Three different modalities, which can be "used to subsequently destroy the capacity and operation of the device 1010 are revealed below." First, attention is drawn to Figure 2, "in which only the necessary parts are shown to describe a way to closepermanently covering the needle 1190 on the member? e tube 1370. As illustrated in FIG. 62, the cone of the nose 1082 comprises an annular horn provided inwards 1300, the surface of which is transverse to the long axis of the needle. the needle 1140 and the tube member 1070. As described above, the travel of the needle cover 1190 is constrained to pass along the long axis of the needle 1140. The needle cover 1190 comprises an enlarged shoulder 1302 which incorporates a pro-ciraally provided transverse face 1304. Because the tube 1180 will be buckled when compressively forced and the cone material of the 1082 warhead will yield sufficiently when the needle cover 1190 is forcibly pushed into the tube member 1070, said Inward movement will ultimately cause the hopbro 1300 to secure against the face 1304, thereby sealing the 1010 device against subsequent use. The elements used in a second method to eradicate the possibility of subsequent use after completing a medical procedure are shown in Figure 50. Sections disposed proximally of the wing portions 1200 and 1 --- 0 ---, each comprising a latching segment arranged transversely between 1310 and 1312, respectively. Complementary bolts 1314 and 1316 are disposed on the inner surface 1210 of the tube member 1070. These latches and hooks are positioned in such a way as to force the needle cover 1190 inwardly within the tube member.1070 with sufficient force and displacement to cause the locks 1314 and 1316 to engage the hooks 1310 and 1312, respectively, presumably constricting the needle 1114 within the tube member 1070, thereby denying subsequent use. , added to shield 1084 (to form shield 1084 ') is seen in Figures 60 and 61 to provide a third method for sealing device 1010 against subsequent use As seen in Figure 60, shield 1084' comprises a cap 1320 disposed vertically and outwardly such that after the needle 1140 is finally retracted by raising the shield 1084 'to give access to the section 1290 to cause retraction, the plug 1320 rotates approximately 90 * being forced into of the tube member 1070. The plug 1320 comprises complementary surfaces "for hooking the surface, as is the shoulder 1300, to securely attach the cap 13 0 and close the 1010 device against subsequent use. Of particular importance is the use of the 1010 device as a pre-filled syringe. The sealed parts must be tightly closed to maintain the effectiveness of the medical fluids contained within the 1240 space. (See Figure 57.) The plug 1260, the slidable seal 1150, the valve 1160, the cover 1190, and the jaber 1190 ' are connections to the medical needle apparatus 1100 which should all provide a substantially closed environment for the medical fluid contained in the pre-filled syringe.
Only when the needle device 1100 is extended for use should the valve 1160 open. It is also preferred that the medical fluid be exposed to an external environment only when the squeegee 1190 'ti- the cover 1190 is removed. To ready the device 1013 for "use", the medical device 1100 is extended by pulling either the cover 1190 or the jamb 1190 'until the hook 1270 is engaged by the bolt 1280, with which valve 1160 is opened. either the cover 1190 or the "squeegee 1190" is then removed. If the squeegee 1190 'is used, a medical needle having a luer fit is connected to the medical needle apparatus 1100. As is common in medical injections, all gas is purged from the pathway and fluid vertically providing the device. 1010 with medical needle 1140 pointing upward, and decreasing volume 1244 until the medical fluid can be seen to escape from needle 1140. A predetermined volume, not necessarily -all volume maintained in space 1240, is dispensed. . Upon completion of this segment of the procedure the medical needle 1140 is retracted by depressing section 1290. As previously described, the needle cover 1190, being protected from unacceptable contamination, may be reinserted and xecected to recover the medical needle device. 1100 for useSubsequent "pre-filled" syringe Upon arriving at the last: To use the device 1010, the cover 119C is forcibly inserted into the shroud of the tube 1070 to secure the needle 1140 for subsequent use. It joins securely into the hole 1386. Referring now to Figure 59, the steps of mounting the 1010 device (of course all fabrication and assembly should be done under properly clean conditions) are seen to comprise: 1. Manufacturing by injection molding or other high volume process, and low cost of punch 1120 -or 1120 '.) It is preferred to make a medical punch 1120 of a synthetic resin material which has a flexibility and sufficient strength to- that the parts that extend? i200 and 1202 'can be used as hooks, while no part of the punch element 1120 should contact the medical fluid, it is preferred The selected material is inert for body fluids as well as for medically injectable fluids. Such material can be selected from an appropriate grade of polyurethane, polypropylene and polyethylene. 2. The medical-grade sidewalk, such as the steel currently used in disposable medical needles, should be used for needle 1140. When the medical guide 1140As an integral part of the punch body 1120 is provided, the needle 1140 is preferably securely attached to the punch member 1220 by means of adhesives currently well known in the art of needle manufacture. When the medical needle comes after the extension of the apparatus 1100, the "punch element 1123" comprises a secure luer adjustment to be connected initially to the squeegee 1190 '. 3. The functions of the component 1110 can, with the The component 1110 is made of a single, generally cylindrical integral part, comprises a seal 1150, a normally closed valve 1160, an interfacing surface 1170 to a ventral surface of a rear portion of the barrel.1020 and an elastic tube 1180. Starting from the proximal end, the elastic tube 1180 is normally closed-unless the tube 1180 is tensioned-by the valve 1160. "the valve 1160 opens on a side distal to the surface, ee interface 1170, which extends? istally to formthe seal 11-50. The operation of seal 1150 as a fluid control device has been described above-and will not be repeated here. The tube 1180 also functions as a fluid regurgitation control device using the processes described in detail below.
The compiler 1110 can be made of a plurality?Currently available products such as a medical grade latex and a silicone rubber. However, nines and higher products are continuously introduced to the market. The material must have the following characteristics: inert 5 effectively "to both body fluids" which can make contact; extendable to a length which allows the latch 1100 to be in a forward condition and in which the length will retract an inserted needle 1140; and able to form an effective seal for the 1150 seal and valve1160. The component 1110 is attached = 1 punch element 1120 (or 1120 ') by means of the punch member 1220. 4. The attached combination of the apparatus 1100 and the component 1110 is then inserted into the recess? 1070 tube, with the wing parts and bracketsof the apparatus 1100 arranged as previously described. As shown in Figure 59, the tube member 1070 comprises an annular groove 1330, The section 1332 of the component 1110 comprises the seal 1150"with an annular slit member 1340 (an o-shaped or integral ring) which iscomplementary to the slot 1330. Also, the section 1332 comprises a thinned annular doubling region 1342 which allows the section 1332 to be bent so that it can be bent on the outer surface of the tube member 1070. The component 1110 is bonded in the form secure in the -tubo member1070 with member 1340 residing in slot 1330 faceform the 1130 stamp on this. Composer 1113 comprises a series of annular rings 1344 to improve seal performance 115C. 5. Once the component 1110 is attached to the tube member 10-70, the needle cover 1190 (or the squeegee 1190 'is attached to the punch member 1120 (or 1120'). 6. Finally, the portion of the seal 1150 of the component 1110 and the tube member 1070 is also forced through the opening 1064 to complete the assembly of the device 1310. The barrel 1020 is shown in Figure 59 as a barrel having a closed distal end. Of course, the barrel 1020 may also have an open but distally closed end, as described above.Although other materials may be used, the needle cover 1190 (squeegee 1190 ') is preferably made of medical grade polypropylene. Similarly, the piston portion 1030 is preferably made of medical grade polypropylene to which other materials which have similar thin-limb tightness qualities can also be used within the scope of the invention. In Figure 62, the piston portion 1030 may be made of two separate injection molded parts and then joined together later. Ultrasonic bonding is preferred, the selection of materials for the barrel 1020 depends strongly on the fluids stored inside it in the applicationere-íleñada. The materials can vary from a synthetic material to a rr-é? Icc grade glass. If a material is not used the material is not absolutely unbreakable, at least one protective cover should be placed over section 1060 at the 1050 isal end. (Not shown!) 7. In a fully assembled device, it is physically preferable. securing the cover 1190 (or pull 1990) to the cone 1082 by "means" of bonding by holes to provide a sterility barrier, a method to restrict the volume of an elongated cube 1180 so that is less than the volume of tube 1130 in its relaxed state was previously discussed in the detailed description of Figures 43-46, exposing Equations 2-14 (the previous reference was made to tube 180.) Additional Modality of Phlebotomy is made now reference to Figure 63 where a modality of a disposable self-piercing needle assembly for phlebotomy 2010 is observed. As fabricated and transported, the 2010 assembly comprises a distal dorsal cover provided to back 2020. "Oh seal 2030 (see separate for the clarity of the presentation), a punch provided forward and front 2040 and a front cover forward or forward 2030. Other parts, hidden inside the assembly" 2010 see " in the cross section in Figure 64. These internal partsthey are provided with a punch provided backwards or backwards 2060", a phlebotomy needle 2070 attached securely to the punch 2060, an elastic tube provided in the needle -2070 and securely attached to the punches 2040 and 2063, a cushion 2080 provided in a pointed tip 2382 of the needle 2070 and a liner 2090 in the protective form encloses the shock absorber 2080 and the end 2082. Each of the parts mentioned above, the assembly 2010 are seen as individual components in Figures 65 to 73 and a schematic view of all the parts in the schematic configuration. It is shown in Figure "4. Referring to Figure 65, the dorsal cover 2020 comprises an elongated cylindrical housing having a rounded distal end 2092 attached and secured to the enlarged portion 2094 by an elongated cylindrical section 2096. The cover 2020 further comprises a "hollow interior surface 2098, shown in Figure 64. Next, cover 2020 runs downward toward the hollow cylindrical section 2100 of a radius meter to portion 2094. The purpose and function of section 2100 are described "- below. preferably of a structurally sound synthetic resonant resonant material- For example, the "medical grade" polypropylene canIn addition, plastic materials such as acrylics and polycarbonates can be used when the economy of the cost of the material is compatible with the cost of the resulting parts. Figure 66 is a perspective view of the front cover 2050. The cover 2050 comprises a closed proximal end 2102 which is joined to the hollow cylindrical section 2104. istal of the section 2104, the cover 2050 is divided into a pair of elongate legs 210"6" "and 2108, each mating comprising rounded distal ends 2110 and 2112, respectively - the front cover 2050 is also preferably made of polypropylene, however, as in the case of the back cover 2020, others Stable restructured synthetic resin materials can be used One embodiment of the 2040 front punch is seen in Figures c "and 67A-C. To be shown in oblique perspective in Figure 67 is the proximal end of punch 204O which "comprises an upper arched slit 2114 and a lower arched slit 2116 surrounding a front punch segment 2113. The section 2118 joins the slits 2114 and 2116 on a front face flat 2120. As best seen in a combination? in Figures 64, £ 7, 673 and 67C, the front punch Sel segment 2113- is a closed hollow cylinder proximate a fissure end? or 2122-.? end 2122 comprises an "X" cut 2124 which provides a closing path through thewhich the needle 2370 is retracted in the contenetor eegure. It is important to note that other types of partial closures can be used to block the re-extension of the 2073 needle through one end, such as the 2122 end. Zn example of another modality is described in? etalle further . Figure 67A shows an oblique perspective of the punch 2040 being born rotation about 90 ° - from the angle of the punch 2340 seen in Figure 67, making the surface and rearwardly or distally 2126 of the visible punch 2040. From the rear, punch 2040 is observed to comprise a tube coupler 2128 in the form of an augmenting or hollow cylindrical "for clamping the tube 2072 to the punch 2040. Preferably, the coupler 2128 comprises an internally provided surface of 2130 which is The same diameter as the outer surface of the tube 2072. The tube 2072 xeside inside the surface 2130 as seen in Figures 64 and 67. C. Also, the material from which the punch 2040 and the tube 2072 are made. they should allow easy adhesion of the tube 2072 to the surface 2130. Other methods and methods for connecting the tube 2072 to the punch 2040 are within the scope of the invention. Extending-istally to the glass end 2132 and the coupler 2128 is a tab. 2134, shown in theFigure 67A. The "function and purpose of the tongue 2134 are fully described below." Half and proximally disposed relative to the surface 2126 is a cylindrical surface 2136 which comprises a fabric pattern 2138 for securely connecting to the barrel. The connection ethic is revealed in detail later on. - Punzen 2040 is made preferably from a medical grade polypropylene, although other materials may be used "which are adhered to tube 2072 and which can have good structural integrity with r-elaci ------ "to the resistance against piercing the needle.The needle 2073 is preferably made of a medical-grade stainless steel cannula with a percutaneous sharp point at the proximal end 2140 and a sharp unformed tip 2142 at distal end 2082. The needle 2070 must comprise a diameter consistent with the diameters? The contemporary needles for phlebotomy and should have a rge sufficient to provide a desired insertion length - (usually one to one and a half inches (25 to 38 millimeters) ', measured as the length extending approximately from a barrel and to provide a desired length of service (approximately .4 inches (10 mm) inside the barrel for introduction into a vacuum tube for sampling. -An oblique perspective of the rear punch 206C is seen in Figure 69. As seen in Figure 69, the punch 2060 comprises an essentially hollow cylindrical body 2148 partially closed at one end by a flat surface 2150. The surface 2150 comprises a pair of arched slits 2152 and 2154 through which the portions of the lining 2090 pass to allow compression of the damper 2080 and give access to the end 2082 and the sharp tip 2142. Generally, the punch 2060 also comprises a needle punch arranged centrally -2156 extended axially outwardly to support the needle 2070. A sub-assembly comprising a needle 2070 -and a punch 206 is seen in Figures 72 and 72A-C. As seen in Figures 72 and 72A, the cylindrical body 2148 comprises a proximal opening slit 2158. The slit 2158 has such a size and position to receive the tongue 2134 when the punches 2040 and 2060 are aligned and arranged in contact with each other. yes. When the tongue 2134 is inserted into the slot 2158, an axial latch is created, which causes the punches 2040 and 2060 to rotate together when either of the punches is moved. In a device mentioned, the needle 2070 is securely attached to the punch 2062, preferably by an adhesive.
As best seen in Figure ~ 2C, the punch 2060 comprises a small punch disposed proximally and centrally 2159, the one providing a mount for the distally disposed end of the tube 2072. The tube 2072 is securely attached to one end of the punch 2159 and on the other end of the coupler 2128. Preferably, the tube 2072 is joined by adhesives which are easily and commercially available. Reference is now made to Figure 70, where tube 2072 is observed. Tube 2072 is preferably a thin walled, relatively high durometer tube. Although a large range of durometers can be used, the preferred range is between 35 and 50 durometers. Unless other diameters can be used, the currently preferred diameter is 0.100 inches (2.54 mm). The length of tube 2072 should be sufficient to completely enclose needle portion 2070 which extends proximally from punch 2060. Currently, the preferred wall thickness of tube 2072 is 0.02O inches (0.51). The tube 2072 can be made from Kraton, a product of Shell Corporation and available through Shell Chemical Company, 4225 Naperville Road, Suite 375, Lisie Illinois 60532-3660- As the 2072 tube is used both as a means to enhance energy as a retractable 2070 needle and as the structural member limiting the lengthWhen the needle 207C is retracted, a non-elastic member 2160 is applied substantially for the total or sufficient length of the tube length 2072. The member 2160 prevents tensioning of the tube 2072, especially after the needle 2070 be retracted. By these means, when the needle tip 2140 is captured "within the punch 2040 after its retraction, the tube 2072 can not be further lengthened to allow access to the tip 2140, which can result in an inadvertent injury. The member 2150 can be any flexing material which follows the changes in the contour of the tube 2072 as the tube 2072 is compressed and which has sufficient tensile power to retard the tensioning under manually applied stress As an example, the thread Nylon can be used An oblique perspective of the damper 2080 is shown in Figure 71. The damper 2080 comprises a proximal open end 2162 and a distal end 2164. In an end 2162, the damper 2080 is securely attached to the punch 206J3 in a smaller punch 2156. End 2164 closes, but is thin enough to allow penetration of tip 2142 through it- Generally, tip 2142 is subject to an unshaped configuration to limit sample contamination which may otherwise result from the passage of tip 2142 tothrough end 2164. Generally, such dampers are currently available in the vacuum-based vacuum extraction technique. It is important that the damper 2080 be made of an elastic material having a durometer which provides sufficient memory as it deforms to substantially recover its original shape after the blood collection tube is moved after the shock absorber 2080 has collapsed. in the case of the 2072 tube, the preferred durometer range for the 2080 amotiguador is 35 to 50, although other durometer values can be used. The liner 2090 provides a motionless protective cover over the cushion 2080 before and after the removal of a sample. During the process of sample extraction, liner 2090 can move freely to provide access to the interface between needle 2070 and the sample collection tube. The liner 2090 comprises an elongated hollow cylindrical shape closed at a distal end 216 except for a hole 2168 through which the tip 2142 traverses to interfere with the sample collection tube. At a proximal end, the liner 2090 comprises a rounded end 2170"and a pair of leg portions 2174 and 2176. The leg portions 2174 and 2176 each comprise a retainer 2180. The leg portion 2176 also comprises a hook 2182. The purpose and function ofleg portions 2174 and 2176 and the associated retainers 2180 are fully described below. Lock 2182 is designed for sex forcibly inserted within a slit, such as a slit 2152 in a punch 2060, for securely but slidably, joining the liner 2090 to the punch 2060. Then, the liner 2090 is prevented from separating the punch 2060 without breaking either the liner 2090 or the punch 2060. Limes connections of injection molded parts are well known in the plastics arts. 2090 is preferably made of polypropylene, although other structurally strong, but flexible materials may be used.
Reference is made to Figure 74 for the description of the construction section of a preferred assembly 2010. Although not necessary within the scope of the invention, it is recommended that the 2010 assembly be attached in the following sequence: 1. Unix the tube 2072 to punch 2040 in the coupling2128. 2. Join the tube 2072 to the punch 2060 in the punch 2159. 3. Insert the tip 2142 of the needle 2070 through the cut "X" -2124 into a proximal punch segment 2118 of the punch 2040. 4. Carefully insert the needle 2070 through tube 2072 and punch 2060, taking care to protectthe tip of the needle 2142 from the unnoticed contact with the portions of either tube 2-072 or punch 2060. Caution: Do not allow tip 2140 to pass through cut "X" 2124, as this could impede percutaneous performance of the needle 2070 and would surely give as-result a useless assembly 2010. 5. Securely link needle 2070 to punch 2060 while maintaining the needle tip position 2140 next to cut "X" 2124. 6. Insert the leg portions of cover 2050 through slots 2114 and 2116 up that are provided relative to the punch 2060 as seen in Figure 64. The apparatus and method for intertracking the cover 2050 with the punch 2060 to maintain the tip of the needle 2140 proximate the punch 2040 is described below. 7. Attach damper 2080 to punch 2050. 8. Attach liner 2090 on damper 2380 to punch 2060. 9. Distally provide dorsal shroud 2020 over distally provided parts of assembly 2010 as seen in Figure 64. 10 Attach a 2030 seal (preferably paper) to the inferred portions of punch 2040 and cover 2020 also seen in Figure 64.11. - In order to maintain intra-packing sterility, an adjustment between the punch segment 2118 and the portion proximate the cover 2050 is sufficiently tight to provide a sterile barrier, and a punch segment 2118 and cover 2050 are bonded together to secure the maintenance of the estexilidad before the use. In this way, assembly 2010 is completed and ready for transport to the place of use. In sampling procedures for blood, the 2013 assembly is used with a 2200 barrel, seen in Figures 5 to 77. Barrel 2200 is preferably made as a single injection molded part. polypropylene As seen in Figure 75, barrel 2200 comprises a barrel portion 2202, an elongated neck segment 2204 and an extended hook and an activation band 2206. Barrel 2200 is similar in shape and function to the barrels used. with the blood collection tubes VacutainersS (Becton blood sampling tubes, Dici-inson and Company of FranJ-iin La, New Jersey). The 2200 barrel further comprises a distal sampling tube access end 2208 and a slit 2210 used in combination with a tab 2212 which is an integral part of band 2206 for detecting the presence of a sampling tube in part 2202 and thus preventing the activation ofretraction of needle 2070, as it is "more fully described below." Slit 2210 and tab 2212 are optional, since such impedance is not specifically required within the field of use of the invention. you see in theFigure 75 or in other modes as determined by the constraints of molding. The band 2206 can also be molded as a separate part and clamped during barrel assembly 2200; however, it is currently preferred to mold the 2200 barrel in total as a unit. The band 2206 comprises a plurality of maintenance hinges (of which the hinges 2214, 2216 and 2218 are examples). The band 2206 also comprises an opening 2220 (seen as a key opening therethrough in Figure 75). Inferiorly provided to a superiorly rounded extremity 2222. The opening 2220 comprises a substantially circular portion 2224, which is of. sufficient diameter to pass the back punch 2060 and the tube 2072. Above the opening 2220, the band 2206 comprises a pair of legs 2226 and 2228 to define a rectangular opening 2230 through which the punch 2060 can not pass. Segment 2004 comprises a proximally arranged thread 2232, which is used in combination with a fabric pattern 2138 to form a secure but releasable connection between segment 2204 and punch 2040-?segment 2204 also comprises a proximal orifice 2234, which provides access to an elongated cylindrical internal surface 2236, "In addition, segment 2204 is integrally connected to barrel portion 2202 at an interface 2238 by a pair indicated by bridges 2240. ( A lower bridge 2240 is not shown in Figure 75.) Juxtaposed with the bridges 2240 are a pair of slits 2242 and 2244, with each slit having a width that is suitable for a portion of the band 2206 to pass through. As a final step in the barrel assembly 2200, the hinges 2214, 2216 and 2218 of the band 2206 are bent and one end 2222 and legs 2226 and 2228 are inserted into the respective slots 2244 and 2242. As seen in Figure 76, the band 2206 , already bent and inserted into the slits 2242 and 2244, there is a spring biased in such a way that the circular portion 2224, which can pass through the punch 2060 is superiorly disposed to a path defined by a cylindrical surface 2236. Reference is made to Figure 77 where, in a cross-section, blocking the path between the cylindrical supexficia 2236 and the intemal cavity 2246 of the barrel pawl 2202 is achieved by the legs 2226 and 2228. The barrel portion 2202 comprises an access hole 2248 distal! to the plane defined by legs 2226 and 2223.
To prepare the 2010 assembly for use with the baxxil 2200, the rear cover 2020 is removed from a remaining portion 225C of the 2010 assembly, as shown in Figure 78, after breaking the seal 2030 which is not shown to give clarity to Then, the 2250 portion is inserted through the hole 2234 between the baxxil 2204 segment with the 209-0 liner being inserted first, as shown in Figure 79, the 2226 and 2228 legs -showed by the lines. stitches) block further insertion, thereby causing punch 2040 to be pushed to contact punch 2060 and tab 2134 to be engaged in slit 2158. This engagement is important for a large number of reasons, but mainly to ensure that the angular arrangement of punch 2060- in relation to punch 2040 is controlled and known. It is considered critical by many medical technicians that the needle tip 2140 is in a predetermined orientation for use. Pushing the punch 2040 to make contact with the punch 2060 results in a compunction of the tube 2072 as shown in Figure 80. The punch 2040 is surely but releasably attached to the barrel segment 2204 by woven members 2138 and 2232. Since it is important that the axial orientation of the needle tip 2140 be known and controlled, it must be taken into account to ensurethe suitable orientation of the punch 2040 in relation to the barrel 2200 when the punch 2040 is finally joined to the segment 220. For this reason, it may be preferred that the slide or bayonet bolt connections connect with the punch 2040 to the segment 2204. When the punch 2060 is pressed hard, it enters the legs 2226 and 2228, the detents 2180 are pressed inwardly by the legs 2226 and 2223 allowing the leg parts 2174 and 2176 of the -forre 2090 to runfreely through the slots 2152 and 2154, respectively, of the punch 2060. In this manner, the liner 2090 moves freely through a sample collection tube and a needle tip 2142 finds a passage through the hole-2168, while the lining 2090 isclutch between the legs 2226 and 2228. However, the liner 2090 is secured in place providing secure protection for the tip of the needle 2142 when the liner is not engaged. After connecting the punch 2040 to the segment2204, the cover 2050 is removed to reveal the tip of the needle 2140 as seen in Figure 80. With the cover 2050- removed from the portion 2250, a waste disposable 2280 joins securely but unequally to the 2200 barrel. A 2200 barrel eersoectiva with the 2260 disposable-olewith the needle tip 2140 uncovered is seen in Figure 81. "At the end of a medical procedure, the band portion 2206 is depressed to align the circular portion 2224 with the punch 2060 thereby releasing the punch 2060 from the container by of the legs 2226 and 2228. As a result the energy stored in the compressed tube 2072 causes the punch 2060 in the associated parts of the disposable 2260 to be displaced distantly within the barrel 2200. When the punch 2060 is displaced from this way, the tip of the needle 2140 retracts within the container securely within the confines of the punch 2040. This condition of the disposable 2260 is best seen in Figures 82 and 83. The "detents 2180 are engaged against the 2060 punch to prevent travel. next to the liner 2090 and thereby protecting the tip of the needle 2142 from the exposure through the hole 2168. The tube 2072 acts to fully cover and enclose a deep portion a of the needle 2070 and the tip of the needle "2142. The tip of the needle 2142 will also be captured within the punch 2040. The disposable 2260 is converted to a relatively rigid structure by means of the clutch of the detents 2180 and the needle 2070 being trapped inside the punch 2040. The integrity of the disposable 2260 is further enhanced by the inelasticity of the member 2160 which restricts further elongation of the tube 2072.
As the hinges 2214, 2216 and 2218 can activate the band 2206 by means of the spring to return to a preactivation state after the retraction of the needle 2070, it is necessary to press the band 2206 once more to remove the disposable 2270 barrel 2200. The elongate 2260 is removed from the barrel 2200 by unscrewing the punch 2040 (when a screw connection is used) of the segment 2204, pressing the band 2206, if necessary and pulling the disposable 2260 proximally through the hole 2234. The shape of the disposable 2260 removed from barrel 2200 is shown in Figure 84. Both needle tips are protective and securely covered for safe disposal. An example of an alternative embodiment of a back punch 2060 'comprises another method to prevent free movement of the liner 2090, when tube 2372 is not compressed (and needle 2070 is not provided for use in the medical procedure), is illustrated in - Figures 85 and 86. A punch 2060 and 2060 'are substantially the same in form and function except that the "punch 2060" comprises an inwardly shifted lug 2270, which is engageable with the distal portion 2272 of the punch 2060 'a proximal end 2274 of the lug 2270 is biased to be set in the middle part against the tube 2072 when the tube 2072 is not compressed in such a manner,that when the tube 2072 is compressed as described above, the proximal end 2274 moves outward, away from the needle 2070. While this happens, the proximal end 2274 is clutched against the punch 2040 v captured therein. - The lug 2270 comprises a lower side 2276 and a bolt 2278 disposed therein. The bolt is arranged to act against the edge of the proximal end 2170 and to stop the lining 2090 so that it does not "travel proximately" (see Figure 73 and 73A), only when the tube 2072 is compressed and the end 2274 is engaged against the punch 2040, liner 2090 is released to travel proximally. This is the condition when the medical needle 2070 is provided for use and when a sampling tube is arranged for use in the baxil 2200. Reference is made to Figures 87 and 88- where an alternative punch shape 2040 'of the punch 2040 shown-Punch shape 2040 'is similar in shape and function to punch 2040, except that when a punch 2040 is used, the tip of needle 2140 is necessarily constrained from passing distally through any front barrier of punch 2040 pox means a connection between the cover 2030 and the punch 2060 and another connection between the cover 2050 and the punch 2040. These two constraints allow the tube 2072 to be slightly compressed until both connections arebreak as a result of inserting the 2010 assembly the 2250 portion within the 2200 barrel, whereby the needle tip 2140 is biased phoxically and the tip 2140 is recessed within the punch 2040. To eliminate the need to slightly compress the 2072 tube , the punch 2040 'comprises a proximal face 2280, which has two stable positions- A first position comprising a concave state proximal of the face 2280 is "seen in Figure" 87. A second position comprising a convex state close to the face 2280 is seen in Figure 88. When not attached to the barrel 2200, the convex face 2280 is distally depressed towards the punch 2060, with "which shortens the effective distance between the face 2280 and the punch 2060 and causing the tip of needle 2140 is proximately provided relative to face 2280. When punch 2040 'is connected to segment 2204 as described above to connect punch 2040 ai s eg 2204, face 2280 is "forced to its" convex state. The change of state does not occur - until the punch 2040 'moves to make contact with the segment 2204 and, therefore, the tip of the needle 214-0 is already extended proximally beyond the face 22H0. However, when the needle 2070 retracted into the barrel -2,200, as it is through the hole 2282, the needle tip is captured inside the punch 2040 'as seen in Figure 88. The use of thepunch 2040 'eliminates any need to lightly squeeze tube 2372 prior to insertion of portion 2250 into barrel 2200. The lock of needle tip 2140 may be cured by many different ways within the scope of the invention. As examples, by retracting the tip of the needle 2140 through a self-locking element (such as the "X" cut 2124 previously described) or by creating a curved relax tube 2072 through a biased shortening of an inelastic member 2160, or by an internal compressor housed within segment 2204 which biases needle 2070 and, therefore, the tip of needle 2140 towards an inner wall of punch 2040. A mechanism for positively preventing leakage of the tip of the needle 2140 of a front punch (as is a punch 2040), after retraction of the needle 2070, a part is interposed between the tip of the needle 2140 and an exit hole 2290 as seen in the Figure 90. A front punch 2040", which is similar in shape and function to punch 2040, except that the" X "cut 2124 is replaced with a plug selective element, such as element 2292, is seen in Figures 89 and 90. In this case, element 2292 is formed fragilizand or the majority of the initial portion of a cap molded into the punch 204C covering an entire space which will be opened to provide access to the needle 2070 of the hole 2290-As best seen in Figure 39, sufficient material is left after fragmentation to allow the element 2292 to remain attached by means of hinges to punch 2040"in a hole 2290 and to remain biased against the needle 2070 all However, after the retraction of the needle 2070, the element 2292 responds to the inherent pre-swellable memory for moving the middle of the hinges at least partially through the orifice of the needle 2070. of stopper 2290 and prevent another proximal travel of needle 2070, such that the tip of needle 2140 is securely held distal to port 2290. Additional Catheter Modality _ Attention is now fixed to Figures 91-96 where observes a modality of a retractable and retractable IV catheter device.The IV catheter device derives energy from the retraction by means of a vacuum pulled as the acicular needle Teter is extended for use. This embodiment comprises a quick-release cover which is used to extend the needle and pads a trigger libbed button with bracket which is activated to retract the catheter needle. As seen in Figure 91, a 2300 catheter device requires only 4 injection molded parts. The parts comprise an elongated barrel 2302 of which acatheter 2310 and a catheter needle 2320 are extended for use and within which the catheter needle 2320"retracts for safe disposal, a dorsal disc 2330 which cours a back portion of barrel 2302 in such a manner that an empty can be created therein when a piston through the barrel 2302, a releasable hook and a needle punch 2340, and a cover 2350 which is used "to extend the catheter 2310 and the needle 2320 of the barrel 2302 to prepare The use of the device 2300 catheter 2300. The device 2300 also comprises a piston 2351, which is similar to the piston for a disposable syringe and which is attached securely to the needle punch 2340. The barrel 2302, closed at its end Dista! 2352 by ----- disc 2330, is seen in Figure 92. Both barrel 2302 and disc 2330 can be made of polycarbonate, although other materials can also be used, which have sufficient structural integrity to combine with the piston 2351 to produce a vacuum within barrel 2302, as the piston pulls into barrel 2302 and for sopoxtax the environmental forces associated with the vacuum. The disk 2330 is preferably bonded by means of adhesive to barrel 2302. The adhesives for diches purposes are well known in the art. Also, as can be seen in Figure 92, the barrel 2302 comprises a trigger releasing batch with bracket 2354, thepreposition and function of which are described later. The button 2354 is molded as an integral part of the baxxil 2302. The baxxii 2302 also comprises several rails 2356 and 2358 and lateral indentations 2360 and 2362, which reliably support the operation of the device 2300. A perspective of the cover 2350 is observed in Figure 93. the cover 2350 comprises an elongated hollow cylinder 2364, which covers and protects before and during elongation "the device 2300" before "its use.Although distal end 2366, the cover 2350 comprises 3 legs, indicated as 2368, 2370 and 2372. The legs 2368 and 2370 are simple extensions which provide axial support until the cover 2350 is removed after the extension of the device 2300. However, the leg 2372 comprises a raised hook element 2374, the purpose and function of which are described below The cover 2350 can be made of polypropylene As seen in Figure 94, the punch 2340 comprises a hook part 2376, discs stabilizers 2378 and 2380 for lateral support of the punch 2340 inside the barrel 2302 and a piston connecting punch 2382. Also, the punch 2340 comprises a cylindrical hole 2384 (see Figure 91) with a size to accept the catheter needle 2320 and a proximal punch 2386 in which the IV 2310 catheter is connected loberably for transport and anterior to theseparation of the punch 2386 after the retraction of the needle 2320. Immediately disposed distally and inferiorly to the punch 23B6 is an overhanging partial lock 2388, the purpose and function of which is further described below. The punch 2382 also comprises a filter (It is not shown which selectively passes gas, but is impervious to liquids, and a trajectory of the needle 2320 towards the filter. These filters are available from Paras.
Corporation. In addition, another trajectory (not shown) is provided from the filter to the atmosphere such that the air resident in the needle 2320 at the beginning of a process escapes through the filter thereby allowing the flow of the fluid to the filter at through the needle2320. Said fluid, when the catheter is placed in a patient's cup, provides a red "signa-1" of which the needle 2320 has entered the vessel. The punch 2382 comprises an outer surface contour 2390 comprising a piston disconnect part, 2392 and a depressed piston anchor portion 2394 for anchoring the piston 2351. Such connection parts are well known in the production of disposable syringes. Reference is now made to Figure 95, in -wherea connection is observed between punch 2340 and the portion ofcover 2350. legs 2368, 2370 and 2372 are engaged in punch 2386 and other portions of punch 2340. Latch member 2374 is selectively engaged in projecting bolt 2388, which causes cover 2350 to be firmly attached to the punch 2340 along the engaging element 2374 and the associated leg 2372 is "confined" within the catheter barrel 2302. However, after the engaging element 2374 is released from the barrel 2302, the rotation of the cover 2350 releases the hook element 2374 of bolt 2388, thereby allowing cover 2350 to be removed from punch 2340 and, therefore, device 2300- In Figure 96, device 23-0-0 is shown with needle 2320 and the 2310 catheter extended. As the cover 2350 is used to pull the punch 2340 outwardly, the barrel 2302 to extend the needle 2320 and the catheter 2310 for use in the medical procedure, a vacuum is pulled into the barrel 2302 by the interaction of the piston 2351, the barrel 2302 and the barrel end closing disc 2330. When the needle 2320 and the catheter 2310 are properly extended and before the cover 2350 is released, the hook 2376 engages in the bolt 2395 disposed distal to the button 2354. To retract the needle 2320, the bracket button 2354 is pressed against the hook 2376 to release the punch "2350. The energy stored by the vacuum thenresident in the volume defined by barrel 2302, disc 2330 and piston 2361, cause "needle 2320 to be moved distally of the enclosure by catheter 2310 and within safe containment of barrel 2302. Another embodiment of a retraction device and needle extension 2400 is illustrated in Figures 97 and 98. Device 2400 comprises a barrel 2402, which is similar to barrel 2202 but does not contain the optional slit 2210), and a segment 2404 which is similar to segment 2204- The segment 2404 also comprises an activating band 2406, which is similar in function to the band 2206 with a pair of legs 2408 and 2410, which are comparable to the legs 2226 and 22:28 The band 2406 also comprises an opening circular 2412 similar to the circular portion 2224, which allows the passage of a rear punch 2414, in a manner in which the rear punch 2060 is allowed to pass through the portion 2224. However, in operation, the p Rear baffle 2414 passes through opening 2412 as needle 2070 is extended for use and then once again as needle 2070 retracts "for secure containment. In Figures 97 and 98, the device 2400 is in its pre-use state. In Figure 93, the device 2400 is shown to further comprise a liner 2416 (which is similar in shape and function to the liner 2090), a damper 2080, a tube 2072, and a front cover2418 (which is similar in form and function to 2050). When the design considerations for the combined barrel 2200, assembly 201C and device 2400 are properly met, three injection molded parts, comprising the liner, the rear punches, and the combined barrel covers 2200, assembly 2010 and the device 2400 can be the same parts. The only other injection molded part of the 2400 device is barrel 2402. A spring can be used in either the 2010 assembly or the 2400 device as an energy storage element. However, a spring is better used in the device 2400 because a retracted needle is completely covered by the barrel portions 2402 and 2404. The most important differences between the parts of the 2010 assembly and the 2400 device are found in the barrel design. The barrel portion 2402 is designed to be an integral part and a part which is deposed with other parts of the 2400 device. For this reason, it is convenient to add a removable label, such as the 2420 label seen in Figure 97, to the cover and the protective die opening 2424 of the barrel part 2402 before use. The device 2400 does not comprise a front punch. Instead of the front punch there is an integrally molded proximal or front part 2426. The integrally molded punch 2426 comprises an orifice for the passage of theneedle 2070, an insertion tongue 2423, viewed as an inner section 2430 of a segment 2404, seen in Figures 98 and 99, because the outer portion of segment 2404 is removed for clarity of presentation and a retainer 2429 annular. To prepare the device 2400 for use in a medical procedure, the hub 2418 is pulled phoximally. As seen in Fig. 98, the cover "2418 comprises a release tab disposed distantly2432, which is inserted through the slit (not shown) in the rear punch 2414 and engaged in the distal face 2434 of the punch 2414. The release tab 2432 is designed to be released by an upward movement in relation with punch 2414. In this way, whenthe cover 2418 is pulled proximally, the tube 2072 is compressed, the punch 2414 is pulled by the tongue 2432 and the liner 2416, the cushion 2080 are in the same way brought forward inside the barrel part 2402 and the segment 2404 20 Three things happen as needle 2070 and punch 2414 are moved in a position for use of the 2400 device. In sequence, the following events prepare the 2400 device for use: 1. A near face surface !, void 2436 ofpunch 2414 is brought into contact with a tongue 2438. Thetab 243B comprises a cam-shaped surface 2440 which, in combination with a proximal movable punch !, 2414, forces the activation band 2406 upward as punch 2414 approaches retainer 2429-2. punch 2414 has passed through "hole 2412, a lower segment"? band 2406 comprises opening 2412 and leg 2410 is free to move upwardly, leg 2410 comprises a foot extending inward 2442 (see FIG. ) the fourth is arranged to come into contact with the tongue 2432 when the punch 2414 is arranged 3. The continuous upward movement of the tongue 2432 discharges the tongue 2432 to prevent engagement on the surface 2434, and the shell 2418 is by thus released to be extracted from the device 2400 to uncover the needle 2070 for use.The downward compression of the web 2406 again places the openings 2412 in the path of the punch 2414 and gives as a The shrinkage of the 2070 needle within a secure containment has occurred. The tip of the needle 2140 should be retained in a secure arrangement proximate the proximal face of the molded punch 2426 before use. A marked difference between the posterior punch 2414 of the 2400 die and the 2060 rear punch mount 2400 is a combination of 2450 slits and the armHook 2452, which are partially illustrated in Figures 98 and 99. The hook arm 2452 comprises an elongated arched extension 2454 engaged by "hinge" means to a side member 2456 of punch 2414 by means of a hinge. 2458. The extension 2454 comprises an extexiox surface 2470, which has an outline essentially equal to the outer surface of the remainder of the punch 2414. As seen in Figure 100, the extension 2454 comprises a pump disposed at a lower position.2472. When the extension 2454 and therefore the pump 2472 are arranged moderately as seen in Figure 98, the pump 2472 acts as a retainer or bolt which prevents the proximal movement of the liner 2416 as well as the retainer 2180 prevents lining 2090. However, pump 2472 is removedcausing the extension 2454 to laterally oscillate out of the passage of the liner 2416 when the tongue 2428 is engaged with the punch 2414, as the needle 2070 is moved proximally by the cover 2418. As seen in Figure 99, the clutch tongue 2428"with punch 2414(and extension 2454) causes extension 2454 to oscillate laterally on piston 3458. Lateral oscillation removes pump 2472 from liner path 2416, allowing liner 2416 to move freely until punch 2414 is disengaged from the segment 2404.? Lclutch disengagement 2414 is caused by pressing the band2406 against the segment 24C4 which, in turn, moves the opening 2412 in an alignment with the punch 2414 releasing the energy stored in the tube 2072 for the punch 2414 and the associated parts di- ately towards and outside the part. on barrel 2402. The securing of the true capture of the 2070 needle in its retraction should be taken into consideration in any of the modalities. Examples of aparates to prevent outward passage of needle tip 2140 have been described above. Another example, seen in Figure 101, is a section of a central portion of a forward punch (designated 2500) showing a symmetrical pipe connection pattern 2502, which retards the re-entry of a retracted needle 2070 into the orifice. of the needle path 2504 in the forward punch 2500. In combination, the tube 207-2 and the hub connection 2502 act to allow the needle 2070 to be retracted through the hole 2504, but allows the needle nose to be biased 2140 comes into contact with an inner face 2506 of the punch 2500 after the needle tip 2140 is fully retracted within the punch 2500. This is achieved by providing a discontinuity 2508 in the wall of the pipe connection 2502. The discontinuity 2508 allows that a section 2510 of the tube 2072 is distorted by the needle 2070 until the needle 2070 is retracted. Nevertheless.after retraction the section 2513 of the tube 2072 relaxes an apposition indicated by the dotted lines 2512 and partially closes the hole of the needle inlet. In this manner, the needle tip 2140 and the needle 2070 are securely trapped within the front punch 2500. The face plate which comprises the inner face 2506 should be puncture-proof or at least resistant to punctures to xaxonable latex forces. placed on the needle 2070 in the direction of the face 2506. In those cases where a front piaca or other needle point 2140 containing parts that are made of the material which is not puncture-proof or not even sufficiently puncture resistant, an airtight needle material should be used to effectively capture and prevent needle tip 2140 from coming out of the punch forward, thereby creating an unsafe condition. Reference is made to Figures 102 and 103 where a forward punch assembly 2600 is observed. The punch assembly 2600 comprises a movable part 2602 (which may be made of a synthetic resin material such as polypropylene). and a spring part 2604-Other than structural differences, which allow part 2604 to be mounted to part 2062, the forward punch assembly 2600 is similar in shape and function to theforward punch 2040 and other similar punches described above. The oldeabie part of the punch 2502 comprises an elongated proximal cylindrical housing segment 2606 and a pair of slots 2114 and 2116 provided in a cylindrical connector portion 2608. The segment 2606- comprises a forwardly rounded end 2610 and a passage of internal cylindrical needle 2612. Sandwiched within an outer surface 2614, is a depression 2616. The depression 2616 comprises a shape easily about insertion of the spring portion 2604. Arranged within the depression 2616 is a latch 2618 and a tongue 2620. The spring portion 2604 is preferably made of a spring steel, although any material, which provides a secure barrier preventing the escape of the needle tip 2142 after the needle 2070 is retracted, may be used. The spring portion 2604 comprises an elongated rod 2622 and a retainer segment 2624, which is essentially at a right angle to the band 2622 to allow insertion of the segment 2624 through the slit 2618 and further the insertion of the segment 2624 through of the slit 2618 within the needle tip 2140 obstructing the position after the needle 2070 retracts. In addition, a support mount -connectable must be used toproviding a secure connection of the spring portion 2534 to the segment 2606 As can be seen in Figures 102 and 103, the spring portion 2504 comprises a mounting hole 2630, which is securely attached to the tongue 2-623, preferably by a pressure adjustment. Such connections are common in the assembly of plastic parts to other parts such as parts made of metal. Once the spring portion 2604 is attached to the punch part 2602, a combination of latch lock connection 2620 in the hole 2630 and the geometry of the interleaver 2616 relative to the spring portion 2605 maintains the structural integrity of assembly 2600. As seen in Figure 103, when needle 2070 is in its pre-use state with needle tip 2140 provided proximate end 2610, segment 2624 rests on needle 2070 through slit 2618 When the needle tip 2140 'is retracted beyond the slit 2618 and the segment 2524 (not shown), the tension of the spring retained in the band 2622 discharges the segment 2624 further into the needle passage 2612 to form a retainer effective and secure. In short, the apparatus and method described herein is a significant improvement of the present state of the art of medical needle devices, self-retractable.
The inventions described herein can be exemplified in other "specific forms without departing from the essential spirit or features.The described embodiments should be considered in all respects only as illustrative and not restrictive.The scope of the invention is, therefore, indicated by the appended claims in lieu of the above descriptions.All changes that may fall within the meaning and range of equivalency of the claims should be encompassed within their scope- What is claimed and is desired to be secured by the Patent of the United States is: