Needle assembly and blood leakage prevention process

专利摘要:
RETURN BLOOD COLLECTION NEEDLE. A needle assembly includes a clear or translucent housing with a fluid inlet and outlet end, a return chamber, and a venting mechanism therebetween. The vent mechanism includes a blocking member to control the flow of fluid in the vent mechanism so that it flows along the longest path through the vent. Substantially axially aligned inlet and outlet cannulas extend from the housing and communicate with the chamber. A sealable sleeve covers the outer end of the outlet cannula. Relative volumes of the cannula, chamber, and sleeve are selected to provide rapid, reliable return indicative of venous entry with an internal vent positioned within the housing to divide the interior into first and second chambers, with the second chamber being adapted to hold there a negative pressure with respect to the external environment so as to inhibit blood leakage from the needle tip with withdrawal from the patient.
公开号:BR112013019708B1
申请号:R112013019708-0
申请日:2011-02-02
公开日:2022-02-01
发明作者:Chee Leong Alvin Tan；Tiong Yee Sim；Yaohan Jon Moh
申请人:Becton, Dickinson And Company；
IPC主号:

专利说明:

Background of the Invention
[001] The present patent application is a continuation-in-part patent application based on the U.S. 12/206273, filed September 8, 2008, titled “Return Blood Collection Needle” which is a continuation-in-part of a patent application based on a U.S. 12/044 354 filed March 7, 2008, also titled “Return Blood Collection Needle”, the entire expositions of each of which are incorporated herein by reference. Field of Invention
[002] The present invention relates to a device for collecting blood samples by performing venipuncture on a patient. More particularly, the present invention relates to a needle assembly for multiple blood sampling which enables a phlebotomist to determine whether vein entry has occurred when collecting a blood sample from a patient into a blood collection tube. evacuated blood. Related Technique Description
[003] Venopuncture is the primary process used to acquire blood samples for laboratory testing. In performing venipuncture procedures, a phlebotomist has to follow several steps simultaneously. Such steps include assessment of the patient's total psychological and physical condition in order to properly select a venipuncture site and technique. The phlebotomist also has to select the corresponding equipment itself, perform the technique to control bleeding, and properly collect and identify fluid specimens for testing. The phlebotomist has to determine all these coincident factors, as such factors can adversely affect the distention of the vein and the length of the venipuncture procedure.
[004] Several venipuncture devices have been developed to address the problems described above. These devices include products intended to assist the phlebotomist in confirming that a vein entry has been made, see, for example, US Patent Nos. 5,222,502 and 5,303,713. Such a device contains a needle assembly with a housing defining a chamber therein. A single cannula pointed at both ends is affixed to the housing. The intravenous (IV) end of the cannula is adapted for penetration into a patient's vein. The non-patient end of the cannula has a sealable sleeve and is adapted for penetration of a penetrable cap positioned within an evacuated container.
[005] Upon entry into a vein with the intravenous end of the cannula, blood will flow through the cannula, into the sealable sleeve and into the housing chamber, which is clear or translucent for viewing (“return”) (“flashback”). Once air is vented from the flashback chamber, the blood there is pressurized each time the sealable sleeve is pushed towards the envelope chamber with activation of an evacuated container.
[006] Due to the length of time between vein entry and flashback, the phlebotomist may erroneously believe that satisfactory vein entry has not been obtained since there is no immediate indication of vein entry in the see-through chamber. The phlebotomist may needlessly repeat the venipuncture procedure, requiring replacement of the evacuated container and/or the needle assembly itself. Such a repetitive process prolongs the physical and emotional discomfort borne by the patient. In such cases, a phlebotomist may use a blood collection set to provide some indication of entry, and will then incur the cost of the blood collection set, as well as the cost of a waste tube.
[007] It may therefore be desirable to provide an improved blood collection device that allows blood flow through a relatively short flow path directly into a flashback chamber, thereby providing immediate indication of successful vein entry. . Summary of the Invention
[008] The invention provides a needle assembly for extracting at least one fluid sample in an evacuated container for laboratory testing. The needle assembly provides a clear or translucent housing with sufficient dead space for blood to flow into a flashback chamber for viewing by the user to confirm successful vein entry, with an internal ventilation mechanism.
[009] In one embodiment, the invention relates to a needle assembly comprising a housing defining a housing interior, a cannula having a patient piercing tip extending from a first end of the housing, and a piercing tip of non-patient extending from a second end of the housing. The non-patient piercing tip and the patient piercing tip are in fluid communication with each other through cannula, so the only communication path between the housing interior and the external environment is through the piercing tip. of patient. A porous vent is positioned within the housing interior to separate the housing interior into a first chamber and a second chamber, with the cannula being in fluid communication with the first chamber. Porous ventilation includes pores for the passage of blood therethrough from the first chamber to the second chamber. The first chamber and the second chamber are configured so that upon insertion of the patient needle tip into a patient, blood flows through the cannula and into the first chamber without porous ventilation sealing. At this point in the process, the “flashback” of blood can be visualized in the first chamber. Upon application of an evacuated container to the non-patient piercing tip, blood is withdrawn from the first chamber and air is withdrawn from the second chamber, thereby establishing a negative pressure within the second chamber with respect to an external environment of the needle assembly. Blood can then be drawn into the first chamber and through porous ventilation, with a negative pressure maintained in the second chamber.
[010] In one embodiment, the cannula includes a first end comprising the patient piercing tip and a second end comprising the non-patient piercing tip, with an opening between the first end and the second end providing fluid communication between the cannula and the first housing chamber. In an alternative embodiment, the cannula comprises a first cannula having a patient piercing tip, with the needle assembly further comprising a second cannula including the non-patient piercing tip, with the first cannula and second cannula aligned substantially axially. and separated by a gap in fluid communication with the first chamber of the housing. A sleeve may also extend around a non-patient piercing tip.
[011] In one embodiment, the second chamber may include multiple interior regions in fluid communication, such as a first interior region and a second interior region. The first and second inner regions of the second chamber are in fluid communication with each other through porous ventilation.
[012] In a particular embodiment, the first end of the housing comprises a first elongated longitudinal portion having a first diameter and a second end of the housing comprises a second portion having a second diameter greater than the first diameter of the first portion. In such an embodiment, the porous vent may be positioned within the housing interior between the first portion having a first diameter and the second portion having a second diameter. Alternatively, the porous vent may be positioned within the housing interior at a location extending the transition between the first diameter of the first portion and the second diameter of the second portion. In embodiments where the second chamber includes multiple interior regions, such as a first interior region and a second interior region, the first chamber may extend along a portion of the first longitudinal portion, with at least one of the interior regions, such as the second interior region of the second chamber extending concentrically longitudinally around the first chamber. In this way, the outer diameter, and thus the outer profile of the needle assembly, can be decreased.
[013] Still in one embodiment, a method of preventing leakage, such as, for example, blood droplets, at the patient piercing tip in a needle assembly is provided. The method involves receiving blood through a patient piercing tip into a first chamber of a needle assembly, with the needle assembly including a needle housing defining a housing interior; a cannula having the patient piercing tip extending from a first end of the needle housing; a non-patient piercing tip extending from a second end of the needle housing, the non-patient piercing tip and the patient piercing tip being in fluid communication with each other via the cannula; and a porous vent positioned within the housing interior and separating the housing interior into a first chamber and a second chamber. The cannula is in fluid communication with the first chamber so that the only communication path between the housing interior and the external environment is through the patient's piercing tip, and the porous vent includes pores for blood passage therethrough. from the first chamber into the second chamber. Fluid communication is established between the non-patient piercing tip and an evacuated collection vessel, so that blood contained within the first chamber is withdrawn into the evacuated collection vessel and air is withdrawn from the second chamber through porous ventilation. As such, a negative pressure is established within the second chamber relative to the external environment of the needle assembly, so that blood flows through the cannula in the first chamber and contacts porous ventilation. Blood is then drawn through the pores of the porous vent towards the second chamber so that upon removal of the patient piercing tip from the patient's vasculature any blood contained within the cannula is displaced away from the patient piercing tip towards the second chamber. based on the negative pressure established within the second chamber.
[014] Additionally, a further step may include establishing fluid communication between the non-patient piercing tip and a second evacuated collection container prior to drawing blood through the patient piercing tip and through the cannula in the second. evacuated collection vessel, followed by release of fluid communication between the non-patient piercing tip and the second evacuated collection vessel.
[015] Still in one embodiment, the invention is directed to a process of collecting a sample of blood from a patient into an evacuated blood collection tube using a blood collection assembly having a patient needle tip and a non-patient needle tip. patient needle tip and a housing having a return viewing chamber. The method involves use of a needle assembly comprising a housing having a porous vent positioned therein to separate an interior of the housing into a first chamber forming the return viewing chamber and a second chamber, the first chamber and second chamber being configured so that which air is drawn from the second chamber through porous ventilation and into the blood collection tube evacuated along with the blood sample, thereby establishing a negative pressure within the second chamber. Negative pressure causes blood to be drawn into the first chamber and contact porous ventilation, whereby after the patient needle tip is removed from the patient, the negative pressure within the second chamber pulls blood from the patient needle tip towards second chamber, thereby preventing blood leakage from patient needle tip after patient removal.
[016] In another embodiment, the invention relates to a needle assembly having a housing defining a housing interior where the housing comprises at least one cannula having a patient piercing tip extending from a first end of the housing and a non-patient piercing point extending from a second end of the housing. The non-patient piercing tip and the patient piercing tip are in fluid communication with each other within the housing interior. The assembly also includes a porous vent positioned within the housing interior separating the housing interior into a first chamber and a second chamber within the housing interior. The porous vent may comprise a tubular member including an axial orifice that surrounds at least a portion of the at least one cannula. A blocking member is located adjacent to, or within the axilla orifice of the porous vent and controls fluid flow through the vent so that the fluid flows along the longest path through the porous vent. This longer path depends on the form of porous ventilation. In an embodiment where the porous vent is cylindrical or tubular in shape having a length greater than the circumference, the flow may be in an axial direction along a longitudinal path through the porous vent. In another embodiment where the porous plug is washer shaped having a circumference that is greater than its length, the flow having the longest path may be in the radial direction. Porous venting with the blocking member reduces or eliminates the amount of uncontrolled fluid flow through porous venting along the shortest path or the path of least resistance. The only communication path between the housing interior and the external environment is via the patient piercing tip. The porous vent has a first end face, a second end face, and a central portion extending between the first end face and the second end face. In one embodiment, the porous vent is configured to cause fluid to flow along a controlled longitudinal path from the first end face to the central portion or second end face of the porous vent and subsequently through an opening. center between the first and second chambers. This central opening may be located adjacent to the central portion of the porous vent. In accordance with another embodiment, the porous vent may be configured to cause fluid to flow along a controlled longitudinal path from the first end face to the second end face and subsequently into the second chamber through the first end face. end face and/or the second end face. In accordance with yet another embodiment, the porous vent may be of a washer shape having the first end face and the second end face locked to cause fluid to flow along a controlled radial path from an inner portion. from the porous vent to the outer circumferential end face of the porous vent and into the second chamber.
[017] The blocking member is configured to block at least a portion of the porous vent to make that portion of the vent non-porous to control fluid flow therethrough. The locking member may block at least a portion of an inner surface of the axial orifice surrounding at least a portion of the cannula. According to one embodiment, the blocking member comprises a pressure-adapted non-porous bushing on the inner surface of the porous vent. This bushing may comprise steel or any other type of metal cannula, an extruded plastic tube, a tubular molded part, and the like. The bushing may have a length that is substantially equal to a length of the porous vent. In another embodiment, the blocking member may comprise an adhesive or sealant located in a space between an inner surface of the porous vent and an outer diameter of the cannula. In accordance with another embodiment, the rear end surface of the porous member may be blocked with an adhesive material to control the flow of fluid through the porous vent. In accordance with yet another embodiment, the blocking member may be formed by melting the internal diameter surface portion of the porous vent. In accordance with another embodiment, the blocking member may be a separate member, such as a tubular plastic or cylindrical member, which is placed in adjacent relationship to the inner surface of the porous vent. This cylindrical member may extend from a portion of the housing.
[018] According to one project, the at least one cannula may comprise a simple cannula extending through the housing. The single cannula may include a lumen extending therethrough, a first end comprising the patient piercing tip, a second end comprising the non-patient piercing tip, and a cannulated opening in the lumen. at a location between the first end and the second end providing fluid communication between the lumen of the cannula and the first chamber of the housing. According to another embodiment, the at least one cannula may comprise a first cannula extending from the housing and comprising the patient piercing tip, and a second cannula extending from the housing and comprising the tip. of non-patient perforation. The first cannula and the second cannula are substantially axially aligned with the housing interior and separated from each other by a gap in fluid communication with the first housing chamber. The first chamber and the second chamber are configured so that with insertion of the patient piercing tip into a patient, blood flows into the first chamber without porous ventilation sealing, and with application of a negative pressure source to the non-porous piercing tip. - patient, blood and air are withdrawn from the first chamber and air is withdrawn from the second chamber, thereby establishing a negative pressure within the second chamber with respect to an external environment of the needle assembly. Upon removal of the patient piercing tip from the patient, negative pressure within the second chamber draws blood from the patient needle tip towards the second chamber to prevent blood droplets from being present in the patient piercing tip.
[019] In yet another embodiment, the invention relates to a needle assembly comprising a housing defining a housing interior. The housing comprises at least one cannula having a patient piercing tip extending from a first end of the housing and a non-patient piercing tip extending from a second end of the housing. The non-patient piercing tip and the patient piercing tip are in fluid communication with each other within the housing interior. A porous vent is positioned within the housing interior to separate the housing interior into a first chamber and a second chamber. The porous vent includes pores for passing fluid therethrough from the first chamber to the second chamber. The porous vent is configured to control fluid flow so that fluid flows along the longest path through it. The needle assembly is designed so that the only communication path between the housing interior and the external environment is via the patient piercing tip and the first end of the housing comprises a first elongated longitudinal portion having a first diameter and the second end of the housing comprises a second portion having a second diameter greater than the first diameter of the first portion. The porous vent is positioned within the housing interior between the first portion having a first diameter and the second portion having a second diameter at a location extending a transition point between the first diameter of the first portion and the second diameter of the second portion. . The porous vent may comprise a tubular member having a first end face, a second end face, and a central portion located between the first end face and the second end face. The tubular member further includes an axial hole configured to surround at least a portion of the cannula. The axial hole defines an inner surface of the porous vent and the assembly further includes a blocking member on the inner surface of the axial hole for blocking at least a portion of the porous vent to make that portion of the vent non-porous to cause fluid to flow. along a controlled longitudinal path from the first end face to either the central location or the second end face and subsequently through a central opening between the first chamber and the second chamber. The blocking member may be a non-porous padding fitted with pressure on the inner surface of the porous vent or an adhesive located between an inner surface of the porous vent and an outer diameter of the cannula. Alternatively, the inner portion of the porous vent may be made non-porous by melting this inner surface portion of the porous vent. In accordance with another embodiment, the blocking member may be a separate member, such as a cylindrical or plastic tubular member, which is placed in adjacent relationship to the inner surface of the porous vent. This cylindrical member may extend from a portion of the housing.
[020] In another embodiment, the invention relates to a needle assembly comprising a housing defining a housing interior. The housing comprises at least one cannula having a patient piercing tip extending from a first end of the housing and a non-patient piercing tip extending from a second end of the housing. The non-patient piercing tip and the patient piercing tip are in fluid communication with each other within the housing interior. A porous vent is positioned within the housing interior separating the housing interior into a first chamber and a second chamber. The porous vent includes pores for passing fluid therethrough from the first chamber to the second chamber. The porous vent is configured to control fluid flow so that fluid flows in an axial direction through it. The housing includes a rear hub that can block a rear end face of the porous vent. Alternatively, the rear hub may leave a portion of the second end face exposed. The rear hub includes a cylindrical portion extending therefrom. This cylindrical portion extends in the first chamber towards the first end of the housing to define a portion of the first chamber. The needle assembly is designed so that the only communication path between the housing interior and the external environment is via the patient piercing tip. The porous vent comprises a tubular member having a first end face, a second end face, and a central portion extending between the first end face and the second end face. The tubular member further includes an axial hole configured to encircle at least a portion of the cylindrical portion extending from the rear hub. The at least one cannula is located within at least a portion of the cylindrical portion. The cylindrical portion extending from the rear hub into the axial hole of the porous vent abuts against the inner surface of the porous vent to act as a blocking member to render a portion of the vent non-porous and to cause fluid to flow along. of a controlled longitudinal path and consequently through either a central opening between the first and second chambers or through the first end face or the second end face of the porous vent. An adhesive may be located between an inner surface of the porous vent and an outer diameter of the cannula and/or the cylindrical portion or the inner surface portion of the porous vent may be fused to render this portion non-porous to aid in flow control. of fluid through porous ventilation.
[021] According to yet another embodiment, the invention relates to a method of preventing leakage of a droplet of blood from a patient piercing tip of a needle assembly. The method includes: a) receiving blood through a patient piercing tip and into a first needle assembly chamber, the needle assembly comprising: i) a needle housing defining a housing interior, the housing comprising at least a cannula having a patient piercing tip extending from a first end of the housing and a non-patient piercing tip extending from a second end of the housing; and ii) a porous vent positioned within the housing interior and separating the housing interior into a first chamber and a second chamber, with the non-patient piercing tip and the patient piercing tip being in fluid communication with one another. with the other inside the first chamber so that the only communication path between the housing interior and the external environment is via the patient piercing tip. Porous ventilation includes pores for passing blood and air therethrough from the first chamber into the second chamber and porous ventilation is configured to control the flow of blood and air so that blood and air flow along the longest path. through it. The process further includes: b) establishing fluid communication between the non-patient piercing tip and a source of negative pressure so that blood contained within the first chamber is withdrawn from the non-patient piercing tip and air is withdrawn from the second chamber through porous ventilation, whereby establishing a negative pressure within the second chamber with respect to the external environment of the needle assembly so that blood flows through the cannula in the first chamber and contacts the porous ventilation; and c) drawing blood and air through pores of the porous ventilation towards the second chamber based on the negative pressure established within the second chamber so that blood contained within a lumen of the patient piercing tip is displaced away from the piercing tip. patient perforation and in the direction of the second chamber. The process is such that the receiving step a) comprises receiving blood through the lumen of the patient piercing tip from a patient's blood stream, and the withdrawing step c) displacing blood away from the piercing tip of patient after removal of the patient piercing tip from the blood source, such as, for example, from a vein. The process further includes the step after step b) and before step c), releasing fluid communication between the non-patient drill bit and the negative pressure source. The porous vent may comprise a tubular member having a first end face and a second end face and wherein the tubular member further includes an axial hole configured to surround at least a portion of the cannula. The method includes making the inner surface of the axial orifice non-porous to cause the fluid to flow along the longer path through the porous vent and subsequently into the second chamber. Depending on the shape of the porous ventilation, this longest path can be either a longitudinal path or a radial path. A blocking member may be provided to render the inner surface of the axial orifice non-porous. This blocking member may be a bushing formed of a non-porous metal or plastic material fitted with pressure on the inner surface of the porous vent, an adhesive located between an inner surface of the porous vent and an outer diameter of the cannula, a portion of fused inner surface of the porous vent, and/or a separate member that is placed in adjacent relationship with respect to the inner surface of the porous vent. Description of Drawings Fig. 1 is a cross-sectional view of a typical needle assembly embodiment of the present invention. Fig. 2 is a cross-sectional view of a second embodiment. Fig. 3 is a cross-sectional view of a third embodiment. Fig. 4 is a cross-sectional view of a fourth embodiment. Fig. 5 is a schematic view of the needle assembly of Fig. 1 before use. Fig. 6 is a schematic view similar to Fig. 5, but showing the first venous entry signal. Fig. 7 is a schematic view of a fifth embodiment. Fig. 8 is a perspective view of a needle assembly having a flash chamber still in one embodiment. Fig. 9 is a rear perspective view of the needle assembly having a flash chamber of Fig. 8. Fig. 10 is an exploded view of the needle assembly having a flash chamber of Fig. 8. Fig. 11A is a cross-sectional view of the needle assembly having a flash chamber of Fig. 8. Fig. 11B is an enlarged cross-sectional view of a portion of the needle assembly of Fig. 11A.A Fig. 12A is a cross-sectional view of a needle assembly having a flash chamber used in connection with a blood collection assembly in still one embodiment. Fig. 12B is an enlarged sectional view of a portion of the needle assembly of Fig. 12A.A Fig. 13A is a cross-sectional view of a needle assembly having a flash chamber used in connection with a blood collection assembly in still one embodiment. Fig. 13B is an enlarged sectional view of a portion of the needle assembly of Fig. 13A.A Fig. 13C is an enlarged sectional view of a portion of the needle assembly of Fig. 13B.A Fig. 14 is a perspective view of the needle assembly of Fig. 13A shown in combination with a blood collection fixture, with a needle guard in a protective position. Fig. 15 is a side view of the needle assembly of Fig. 14. Fig. 16 is an enlarged side sectional view of the needle assembly of Fig. 15 without the cannula. Fig. 17 shows a cross-sectional view of the needle assembly of the invention, without the cannula, according to a drawing including a blocking member located within the porous vent. Fig. 18 shows a perspective view of the porous ventilation shown in Fig. 17. Fig. 19 shows a cross-sectional view of porous ventilation along line XIX-XIX of Fig. 18. Fig. 20 is a cross-sectional view of the needle assembly using a porous vent without a blocking member showing the uncontrolled radial flow of fluid along the shortest path through the porous member. Fig. 21 is a non-cross-sectional view of the needle assembly of the invention including the locking member of the invention and showing an embodiment of controlled fluid flow along the longest path through porous ventilation where the longest path is in the longitudinal direction. Fig. 22A shows a cross-sectional view of the needle assembly according to an alternative design of the invention. Fig. 22B shows a cross-sectional view of the needle assembly according to another drawing of the invention. Fig. 22C shows a cross-sectional view of the needle assembly according to yet another drawing of the invention. Fig. 22D shows a cross-sectional view of the needle assembly in accordance with yet another drawing of the invention. Fig. 23A shows a cross-sectional perspective view of the needle assembly of the invention according to another drawing. Fig. 23B shows a close-up cross-sectional perspective view of the porous ventilation and chamber arrangements of Fig. 23A.A Fig. 24 shows a cross-sectional view of the needle assembly of the invention according to another drawing. Fig. 25 is a cross-sectional view of the needle assembly of the invention including the locking member of the invention and showing another embodiment of controlled fluid flow along the longest path through porous ventilation where the longest path is in a radial direction. Detailed Description
[022] One embodiment of the invention provides a blood collection needle assembly that provides a visual indication of vein entry ("return") with blood or other fluid sample collection from a patient in one or more blood collection tubes. evacuated and inhibits leakage of blood or fluid sample from the IV cannula with patient removal.
[023] Various embodiments of the present invention are shown in the Figures. Referring to Figures 1-6, this embodiment is directed to a needle assembly 210 with a housing 212 having a fluid inlet end 214, a fluid outlet end 216, and a trunk-shaped outer wall 218 extending between the ends. Outer wall 218 defines housing interior 220.
[024] Housing 212 further includes a cylindrical inner wall 224 that extends into housing 220 from a fluid inlet end 214 substantially concentrically with cylindrical outer wall 218 to a vent plug 900. The cylindrical inner wall 224 and vent plug 900 define a flashback chamber 226.
[025] Needle assembly 210 also includes a fluid inlet cannula 236 having an outer end defining a tapered bevel and an inner end 244 which is fixedly mounted to fluid inlet end 214 of housing 212. Fluid inlet cannula 236 is further characterized by a substantially cylindrical lumen extending between the ends and communicating with the interior of housing 212.
[026] The needle assembly 210 further includes a fluid outlet cannula 252. Referring to Figs. 5-6 , outlet cannula 252 terminates in a blunt inner end 254, an outer end defining a tapered bevel, and a substantially cylindrical lumen extending between the ends. Exit cannula portions 252 between the ends are securely affixed to outlet end 216 of housing 212. Exit cannula 252 is mounted so that inner end 254 passes substantially coaxially with inner wall 224 and so that inner end 254 of cannula outlet 252 aligns substantially axially with inner end 244 of inlet cannula 236. Additionally, inner end 254 of outlet cannula 252 is spaced only a short distance from inner end 244 of inlet cannula 236. An axial clearance between inner end 252 is spaced only a short distance from inner end 244 of inlet cannula 236. 254 of outlet cannula 252 and inner end 244 of inlet cannula 236 that is less than 0.5 mm can result in a return that is inconsistent.
[027] Cylindrical inner wall 224 is sized relative to outlet cannula 252 to obtain both desirable blood flow through assembly 210 and to obtain effective return indication. In particular, cylindrical inner wall 224 is preferably sized to provide a radial clearance around outlet cannula 252 of about 0.2 mm, as indicated by dimension "c" in Fig. 1. This clearance achieves substantially laminar blood flow within return chamber 226 and prevents blood hemolysis. Additionally, the small radial clearance between cylindrical inner wall 224 and outlet cannula 252 allows a drop of blood to be spread thinly through the radial clearance in return chamber 226 to provide an increased return indication with a very small blood volume. Thus, an easily visualized return indication is quickly obtained at the first appearance of blood from inner end 244 of inlet cannula 236.
[028] Needle assembly 210 further includes a sealable sleeve 261 mounted to fluid outlet end 216 of housing 212 and outer end cap 258 of outlet cannula 252 when sealable sleeve 261 is in a non-slanting condition. However, sealable sleeve 261 may collapse in response to pressure exerted by the cap of an evacuated tube to push outer end 260 of outlet cannula 252 through both the sealable sleeve 261 and cap of an evacuated tube, as is known in the art.
[029] The above realization is described in terms of a vent plug. However, any ventilation mechanism is suitable. The venting mechanism may be, for example, a porous vent plug formed from a matrix or carrier material, typically hydrophobic, that is coated with, impregnated with, or otherwise contains a hydrophilic material that swells with contact with water-containing or aqueous substances. The hydrophobic carrier material may be, but is not limited to, high density polyethylene, polytetrafluor ethylene, ultra high molecular hair polyethylene, Nylon 6, polypropylene, polyvinylidene fluoride and polyether sulfone. The swellable nature of the hydrophilic material therefore provides a sealing function in blood contact ventilation. It is also possible to use a porous ventilation plug that becomes sealed upon contact with blood using biological phenomena, for example, through coagulation and/or agglutination of cells blocking ventilation; a superabsorbent material for sealing the swelling vent on contact with an aqueous fluid; a porous vent configured to form a tortuous path for fluid movement therethrough; or a one-way valve (e.g., a thin flap such as plastic film covering a vent, a collapsible seal such as a rubber or plastic duckbill valve, or a collapsible wrap over a vent). It should be noted that any combination of these various mechanisms is also possible.
[030] Figs. 2-4 show realizations with variable vent plugs. Fig. 2 shows a ventilation plug 900a which is located at the end of the cylindrical inner wall 224a and fitted into a recess 301 in the non-patient inner wall of the housing 300. Fig. 3 shows a vent plug in a location similar to that in Fig. 2, meanwhile, vent plug 900b has a shoulder 901b. Fig. 4 shows a vent plug 900c which is located within cylindrical interior wall 224c and recess 301 in housing interior non-patient wall 300, and has a shoulder 901c. The location of the vent plug in each of these embodiments is such that no air can flow out of the return chamber 226 within the housing 220 without passing through the vent mechanism (900 a,b,c).
[031] Figs. 5 and 6 provide schematic representations of the needle assembly 210 of Fig. 1 before and after a conventional venipuncture, in which the needle assembly 210 is connected to a retainer (not shown) and pierces the patient's skin to make a vein entry. With vein entry, blood enters the IV cannula 236 and flows toward the return chamber 226. Blood flows from the inlet cannula 252 into the space between the inlet and outlet cannula, so that blood flows in the outlet cannula 252 and the return chamber 226. At this time point, return chamber 226, indicates successful vein entry and reduces the volume of air present in sheath 212 shown in Fig. 6. Air that was at atmospheric pressure within lumen of IV cannula 248, return chamber 226, interior of sheath 220, and lumen of non-patient cannula 262 prior to vein entry, thus experiencing compression due to the influence of venous pressure and this air is therefore forced through the IV cannula 236 shown in Fig. 6 into the return chamber 226 and through vent plug 900 into chamber 220. Blood flow within housing 220 is prevented by vent plug 900, which allows pressurized air to flow therethrough, but seals, and sometimes it seals completely, in contact with blood, thereby drawing compressed air (at venous pressure) within housing 220. Blood flow in the entire needle assembly ceases once the pressure within chamber 226 and venous pressure are equal.
[032] Once the steps shown in the previous paragraph have taken place, and venous entry is visually confirmed by the phlebotomist, an evacuated container (not shown), is then inserted into the retainer so that the outer end 260 of the second cannula 252 penetrates the cap of the container. , as known in the art. With penetration of the cap by second cannula 252, a negative pressure gradient is transmitted to chamber 226, causing blood to flow from chamber 226 into the container.
[033] The needle assemblies described above should desirably be small for convenient use, but should be constructed to ensure reliable and fast flashback. The return occurrence in the needle assemblies described and illustrated above operates according to the ideal gas law. In particular, at very low densities all gases and vapors approach ideal gas behavior and closely follow Boyle and Charles laws given by:P1V1 = P2V2where:P1 represents the air pressure inside needle assembly before needle insertion ;P2 represents the air pressure inside the needle assembly after entry into a vein; V1 represents the volume of air inside the needle assembly before entering the vein; eV2 represents the volume of air inside the needle assembly after vein entry.
[034] Design parameters should keep the needle device as small as possible for ease of use, while ensuring an appropriate volume as specified by the preceding equation. Figs. 5 and 6 provide schematic representations of the needle assembly 210 of Fig. 1 for purposes of representing ideal gas law enforcement. In this sense, A identifies the volume of lumen 248 through inlet cannula 236. B represents the total volume of the interior of housing 220, return chamber 226, lumen 242 through outlet cannula 252 and sealable sleeve 261. Referring again to the above equation, P1 is the pressure within the needle assembly 210 before use, and therefore substantially equal to atmospheric pressure. Atmospheric pressure will vary slightly from time to time and from location to location. However, for the purposes of this analysis, atmospheric pressure P1 will be assumed to be 760 mm of Hg. P2 in the above equation is the volume of dead space in needle assembly 210 after vein entry. More particularly, after vein entry, blood will fill lumen 248 of inlet cannula 236, thereby reducing the volume to be occupied by gas in remaining needle assembly portions 210 and therefore increasing air pressure in the remaining needle assembly portion 210. needle 210. A needle assembly with dimensions approximately as shown in Fig. 1 will have a P2 pressure of about 790 mmHg in venous pressure (with tourniquet). V1 in the above equation defines the total dead space volume in needle assembly 210 before use, and therefore will equal A+B as shown in Fig. 5. V2 defines the dead space in the device after vein entry, and with inlet cannula lumen 248 236 filled with blood. Therefore, V2 in the above equation will equal B. These input parameters can be used to define a minimum desired size for the respective needle assembly components 200 as shown in the following application of the ideal gas law equation. P1V1=P2V2P1/P2 = V2/V1760/790 = B/(A+B)0.962 = B/(A+B)0.962(A+B) = B0.038B = 0.962AB=25.3A
[035] Therefore, dead space in housing 212, outlet cannula 252 and sleeve 261 is advantageously at least 25.3 times the volume defined by lumen 248 through inlet cannula 236 and more advantageously is about 26 times the volume of 248 lumen. However, other configurations are possible and will work as described here.
[036] The immediate response when an evacuated tube is placed in communication with the outlet cannula 252 is to draw blood from the vein in the tube (not shown).
[037] The highest pressure gradient is always maintained between the vein and the evacuated tube. An axially aligned inlet cannula 236 and outlet cannula 252 therefore provide an unobstructed path for blood flow from the vein in the evacuated tube.
[038] When the required tubes are filled with blood, the needle assembly is removed from the vein. The sealed nature of vent plug 900 inhibits pressurized air within housing interior 220 from then moving into return chamber 226 and inlet cannula 236, which can promote dripping of blood from the IV cannula tip.
[039] The preceding realizations show structurally separate inlet and outlet cannulas that are axially aligned with each other and placed in close end-to-end relationship with each other. However, the principles of the invention described above can also be achieved with a single cannula formed with a slit or transverse opening within the return chamber. For example, Fig. 7 schematically shows a needle assembly 310 with a housing 312 and housing interior 320 that is substantially identical to housing 212 described and illustrated above. Needle assembly 310 differs from needle assembly 210 in that a single double ended needle cannula 336 is provided and passes entirely through housing 312. More particularly, needle cannula 336 includes a venous inlet end 338, a patient 340 and a lumen 342 extending therebetween. Cannula portions 336 within inner wall 324 include a slit or opening 344 to provide communication between lumen 342 and return chamber 326 within inner wall 324. Needle assembly 310 functions in substantially the same manner as needle assembly 210 described and illustrated above. .
[040] Figs. 8-10, 11A, and 11B show a needle assembly further in one embodiment of the invention. In certain embodiments of the needle assembly described with reference to Figs. 1-7, the housing interior includes a vent plug 900, which seals the 226/326 return chamber from the 220/320 housing interior. In such previously described embodiments, the vent plug is described as sealing with blood flow in the return chamber, thereby inhibiting any pressurized air that may develop within the 220/320 housing chamber (such as with air displacement from return chamber 226/326 in housing chamber 220/320 during the initial flash procedure) from moving in a reverse direction towards the inlet cannula. In carrying out Figs. 8-10, 11A and 11B, a porous vent is positioned within the housing at a location such that the vent divides the housing into two chambers having sizes and dimensions for establishing predetermined volumes therein. In addition, porous ventilation remains porous to blood and does not seal in contact with blood. Desirably the blood does not contact the porous vent at the initial flash indication, but such contact occurs at a later point during use of the mount, as will be described in more detail here.
[041] For example, Figs. 8-10, 11A, and 11B show a needle assembly 410 similar to that described in connection with Figs. 1-6 above. As shown in Figs. 8-10, 11A, and 11B, needle assembly 410 includes a housing 412 having a fluid inlet end or first end 414 and a fluid outlet end or second end 416. Needle assembly 410 includes exterior wall 418 defining the interior of wrapper. Outer wall 418 extends generally longitudinally at first end 414 forming a first elongated longitudinal portion 419 having a first diameter. At second end 416, outer wall 418 forms a second portion 421 that has a second diameter that is generally larger than the first diameter of the first portion 419. Likewise, housing 412 can form a structure having a generally T-shaped cross section. Outer wall 418 at second end 416 may be a separate element 428 that can be attached to main body portion 430 forming housing 412, thereby aiding in fabrication and assembly of needle assembly 410. First portion 419 and second portion 421 may be arranged relative to one another in a variety of arrangements, as far as they are capable of functioning to transport air therebetween as discussed herein.
[042] Needle assembly 410 further includes a fluid inlet cannula 436 extending from first end 414 of housing 412. Fluid inlet cannula 436 includes an outer end defining a first piercing point such as a chamfer tapered into patient piercing tip 438, and extends into first end 414 of housing 412 into open end 429, and may be fixedly mounted thereto. Fluid inlet cannula 436 is further characterized by a substantially cylindrical lumen extending between the ends and communicating with the interior of the housing 412.
[043] Needle assembly 410 also includes a second piercing tip such as non-patient piercing tip 462 extending from second end 416 of housing 412. As seen in Fig. 10, this may be accomplished by providing needle assembly 410 with a second cannula in the form of a fluid outlet cannula 452. In particular, the fluid outlet cannula end 452 can define a tapered chamfer forming a piercing tip. of non-patient 462. Fluid outlet cannula 452 extends within second end 416 of housing 412, and may be fixedly mounted thereto. Fluid outlet cannula 452 is further characterized by a substantially cylindrical lumen communicating with the interior of housing 412. Outlet cannula 452 is mounted within housing 412 such that an inner end 464 passes substantially coaxially therein so that the fluid cannula 452 is mounted within housing 412. outlet 452 substantially aligns with the inner end of inlet cannula 436. Desirably, this is achieved by mounting outlet cannula 452 at a location adjacent to second end 416 of housing 412, such that inner end 464 outlet cannula 452 extends within housing 412 to a location adjacent to inner end 439 of inlet cannula 436. As seen in Fig. 11B, the inner end 464 of the outlet cannula 452 is spaced only a short distance from the inner end 439 of the inlet cannula 436, thereby forming an axial clearance therebetween for blood flow in the return chamber (flashback) 426 around of outlet cannula 452. The distance between the inner end 464 of outlet cannula 452 and the inner end 439 of outlet cannula 436 forming the axial clearance is sufficient to provide blood flow in the flashback chamber 426, based on the patient's blood pressure after venipuncture. In certain embodiments, an axial clearance that is less than 0.5 mm can result in a return that is inconsistent.
[044] As seen in Fig. 11B, fluid inlet cannula 436 and fluid outlet cannula 452 are positioned and sized within housing 412 so as to obtain both desirable blood flow through assembly 410 and to obtain effective return indication. In particular, wall 418 of housing 412 is sized to provide a radial clearance around outlet cannula 452 of about 0.2mm in an area surrounding its inner end 464. This clearance achieves substantially laminar blood flow within the delivery chamber. return 426 and prevents blood hemolysis. Additionally, the small radial clearance between inner wall surface 418 and outlet cannula 452 in the area surrounding inner end 464 allows a drop of blood to be finely spread through radial clearance in return chamber 426 to provide an increased return indication with a very small volume of blood. Thus, an easily visualized return indication is quickly obtained at the first appearance of blood within return chamber 426. It is contemplated that inner end 464 of outlet cannula 452 may be partially supported within housing 412 as far as blood flow in the chamber return 426 is obtained around inner edge 464.
[045] In an alternative arrangement, a single cannula is provided, similar to that embodiment discussed in connection with Fig. 7. Such an arrangement is shown in the realization of FIG. 12A and 12B (shown in connection with a blood collection assembly as will be described in more detail herein). In such an arrangement, the fluid inlet cannula and the fluid outlet cannula represent a single cannula 470, having a patient piercing tip 438, a non-patient piercing tip 462, and a lumen 442 extending therebetween, and with cannula body 470 being fixedly attached to a housing portion 412 and passing entirely through housing 412. A cannula portion 470 extending through housing 412 includes one or more openings such as a slit or opening 444 to provide communication between lumen 442 and return chamber 436 within housing 412. In the embodiment seen in Figs. 12A and 12B, two semi-circular cuts forming the opening are shown as opposite sides of cannula 470, although it is contemplated that any number of such openings may be included for providing blood flow in the return chamber 426.
[046] Returning to the realization of Figs. 8-10, 11A, and 11B, needle assembly 410 further includes a sealable sleeve 461 mounted over fluid outlet end 416 of housing 412. This may be accomplished by providing a mounting boss 429 on second end 416 of housing 412, such as element 428, with sealable sleeve 461 representing an elastomeric element that can be frictionally fitted or otherwise affixed over protuberance 429. Sealable sleeve 461 covers non-patient piercing tip 462 at the outer end outlet cannula 452 when sealable sleeve 461 is in a non-slanting condition. However, sealable sleeve 461 may collapse in response to pressure exerted by the cap of an evacuated tube to push outer end 462 of outlet cannula 452 through both the sealable sleeve 461 and the cap of an evacuated tube, as is known in the art.
[047] The realization of Figs. 8-10, 11A, and 11B further includes a porous vent 910 positioned within housing 412. Porous vent 910 is positioned within housing 412 to divide housing 412 into two distinct chambers, e.g., a first chamber represented by a return chamber 426 and a second chamber represented by secondary chamber 427. Porous vent 910 may be constructed of a suitable material as described above with respect to vent plug 900, albeit without the hydrophilic material that swells on contact. In this manner, porous vent 910 is adapted to vent air therethrough, and represents a porous structure including a plurality of pores that allow blood to pass therethrough without sealing the flow of fluid therethrough with blood contact, as is known in the art with vent plugs including a hydrophilic material. As discussed in more detail herein, during use of needle assembly 410, the internal pores within porous vent 910 will fill at least partially with blood due to the negative pressure established within secondary chamber 427. Such pores filled in combination with the pressure negative pressure within secondary chamber 427 prevent airflow between secondary chamber 427 and return chamber 426, and provide fluid resistance to blood flow through porous ventilation 910 as will be further described in detail.
[048] Desirably, porous vent 910 is positioned within housing 412 between first portion 419 and second portion 421. In this manner, first portion 419 of housing 412 essentially defines return chamber 426, and second portion 421 of housing 412 essentially defines secondary chamber 427. Alternatively, porous vent 910 may be positioned within housing 412 at a location extending the transition between the first diameter of the first portion 419 and the second diameter of the second portion 421, as shown in the embodiment of Figs. 12A and 12B. In either case, porous vent 910 is generally a cylindrical shaped member with a central opening therein axially circulating a portion of the cannula, particularly fluid outlet cannula 452.
[049] The interior volume of housing 412 is defined by the sum of the volumes of the return chamber 426 and secondary chamber 427 as well as the volume represented by the porous ventilation pores 910. Such interior volume is configured in order to provide certain attributes for the assembly. nozzle 410, in particular with respect to the ability of the secondary chamber 427 to be at least partially evacuated of a portion of the air to establish a negative pressure therein by applying an evacuated tube to the needle assembly 410 during its use. Such negative pressure within secondary chamber 427 draws blood through vent pores 910 based on when blood contacts vent vent 910 and partially fills its pores. In a particular embodiment of the invention, the total interior volume of housing 412 can be from about 300 mm3 to about 400 mm3. Such a volume is particularly useful for the intended use of needle assembly 410 for conventional venipuncture for withdrawing a blood sample from a patient using a needle cannula having a conventional measurement for venipuncture as is known in the art. Such a volume also allows the needle assembly to be particularly useful with patients having a relatively low blood pressure, where the interior volume of the housing 412 is sufficient to allow adequate displacement of air so that blood will travel the full length of the cannula. fluid inlet 436 and return chamber 426.
[050] Porous vent 910 is desirably positioned within housing so as to define a return chamber 426 as having a volume representing from about 5 percent to about 20 percent of the total volume of housing 412, desirably of about 7 percent to about 12 percent of the total volume of housing 412, including secondary chamber volume 427 and the volume of pores within porous vent 910. In this manner, the remaining internal volume of housing 412, defined by the positioned internal volume downstream of the porous vent interface 910 and return chamber 426, including the porous vent internal pores 910 and the secondary chamber volume 427, represents a significant portion of the housing internal volume 412. Such a ratio of the return chamber 426 to the The total volume of sheath 412 ensures that the return chamber 426 has sufficient volume for adequate visualization of the initial flash, desirably while preventing blood from contacting the entire body. Use porous ventilation 910 in initial venipuncture, based on the initial development of pressure within the secondary chamber 427 caused by venous pressure forcing blood into the return chamber 426. Such volume ratios are effective for the intended use as further described herein in details, where blood flowing in return chamber 426 with initial venipuncture does not entirely contact porous vent 910, and desirably does not contact porous vent 910, and where at least a portion of the air is withdrawn
[051] of the secondary chamber 427 based on the application of an evacuated blood collection tube to the needle assembly 410. In this way, secondary chamber 427 can effectively draw blood from within the return chamber 426 and from within the inlet cannula 427. fluid 426 towards secondary chamber 427, such as in and through, porous vent 910, so that when patient piercing tip 438 is removed from the patient and exposed to the external environment, blood is drawn from piercing tip 438 , preventing leakage of blood droplets from the piercing tip 438. In a particular embodiment, the total interior volume of the housing 412 is about 380 mm 3 , with the return chamber 426 having a volume of about 30 mm3, the secondary chamber 427 having a volume of about 300 mm3, and the pores of the porous vent 910 representing a volume of about 50 mm3.
[052] Needle assembly 410 can be assembled as follows. Fluid inlet cannula 436 is positioned through first end 414 of housing 412 such that open inner end 439 is positioned within an interior portion of housing 412 in first portion 419 and patient piercing tip 438 extends externally from first end 414. Fluid outlet cannula 452 is positioned within housing 412 through opposite end, such that open inner end 464 is positioned within an interior portion of housing 412 in a first portion 419 adjacent inner cannula end 439 fluid inlet nozzle 436, with a slight gap therebetween, and with non-patient piercing tip extending externally from second end 416. Fluid inlet cannula 436 and fluid outlet cannula 452 may be affixed thereto in in a known manner, desirably via a medical grade adhesive.
[053] In alternative embodiments including only a single cannula 470, such cannula 470 is affixed within housing 412 so that opening 444 is positioned within housing 412 in first portion 419, with patient piercing tip 438 extending externally from first end 414 and non-patient piercing tip 462 extending externally from second end 416.
[054] Porous vent 910 is then inserted into housing 412 and positioned over fluid outlet cannula 454 (or single cannula 470), and element 428 is then affixed to second end 416, enclosing the housing interior. 412. Sealable sleeve 461 is then affixed over protuberance 429. As such, the interior of housing 412 is closed off from the external environment, as the only path for fluid communication between the interior of housing 412 and the external environment being provided through a tip. patient perforation 438.
[055] Needle assembly 410 assembled as such may be used in connection with a blood collection tube retainer 800, as shown in the embodiment shown in Figs. 12A and 12B. Such an assembly may be accomplished through an open rear end of blood collection tube retainer 800, such that the entire needle assembly 410 is inserted into a portion where at least a patient piercing tip 438 and at least a portion of inlet cannula 436 extends through front end of blood collection tube retainer 800. In embodiments where second needle mounting portion 421 410 is radially larger than first portion 419, such an insertion and arrangement allows the chamber secondary 427 is entirely contained within internal space within collection tube retainer 800, and with return chamber 426 extending outwardly from a front end thereof.
[056] In use, needle assembly 410 may be provided with collection tube retainer 800 attached thereto. Patient piercing tip 438 is inserted through a patient's skin and into the patient's vasculature, desirably into a vein. With venipuncture, a closed environment is obtained within housing 412, since housing 412 is an entirely closed structure, and since sealable sleeve 461 closes off the single housing outlet 412 (i.e., fluid outlet cannula 452). Patient blood pressure causes blood to flow through patient piercing tip 438, into fluid inlet cannula 436, and out of inner end 439 (or through opening 444 in the embodiment of Figs. 12A and 12B), into the delivery chamber. return 426 surrounding inner end 464 of outlet cannula 452. The transparent or translucent nature of housing 412 allows visualization of blood within return chamber 426, providing an indication that venipuncture is obtained.
[057] Since the interior of housing 412 is a closed environment, the flow of blood in the return chamber 426 causes air to be entrained within the housing, including the inside of the return chamber 426, porous vent 910 and secondary chamber 427 , as well as inside the fluid outlet cannula 452, causing such entrained air to be slightly pressurized there. Return chamber 426 and secondary chamber 427 are configured through their sizes and dimensions so that their volumes allow blood flow in return chamber 426 in this initial venipuncture, but air pressure develops within porous ventilation pores 910 and within chamber 427 prevents blood from contacting the porous vent 910 entirely, and desirably prevents blood from even partially contacting the porous vent 910 at the initial venipuncture.
[058] After such initial venipuncture and flash visualization, a sample collection container having a negative pressure therein, such as an evacuated blood collection tube (not shown) as is commonly known in the art, is inserted into the tube retainer. 800. The cap (not shown) of such an evacuated container contacts and displaces sealable sleeve 461, causing the non-patient piercing tip 462 to pierce through sealable sleeve 461 and through the cap of the evacuated container. At this point, fluid communication is established between the non-patient piercing tip 462 and the interior of the evacuated collection vessel. Negative pressure within the evacuated collection container draws blood that has collected into the return chamber 426 in the fluid outlet cannula 452 and into the evacuated collection container. Along with the blood within the return chamber 426, the negative pressure within the evacuated collection container will also draw at least a portion of the air out of the return chamber 426 and out of the secondary chamber 427 through porous vent pores 910, in the direction from and into the evacuated collection container. In addition, the proximity and alignment of fluid inlet cannula 452 and fluid inlet cannula 436 causes blood to be withdrawn from fluid inlet cannula 436 and from the patient, simultaneously with such air being withdrawn from the return chamber. 426 and secondary camera 427.
[059] Such air withdrawal reduces the pressure inside the return chamber 426 and the secondary chamber 427, establishing there a negative pressure with respect to the patient's bloodstream and with respect to the external environment. This negative pressure, which has been established within housing 412, and specifically within return chamber 426 and secondary chamber 427, draws additional blood from within fluid inlet cannula 436 and from the patient into return chamber 426, with the blood contacting ventilation. porous vent 910. With such blood filling return chamber 426, the blood entirely contacts the porous vent surface 910 which extends into return chamber 426, and begins to fill the porous vent pores 910. Such porous vent pore filling 910 910 that are directly at the porous vent interface 910 and return chamber 426 shut off the flow of air through the porous vent, but not entirely act as a seal, in that blood does not cause the porous vent material to swell or close the airflow, but instead merely physically fills the voids within porous ventilation. Furthermore, since a portion of the air within secondary chamber 427 has been withdrawn from secondary chamber 427, secondary chamber 427 represents a closed chamber with negative pressure relative to the external environment. Since the volume of secondary chamber 427 represents a substantial portion of the total interior volume of housing 412, a significant portion of the interior volume of housing 412 downstream of the filled pores at the porous vent interface 910 and return chamber 426 remains at a pressure negative with respect to the rest of the interior volume.
[060] Secondary chamber 427 will therefore continue to have an effect drawing blood from within vent pores 910 and from within return chamber 426 through porous vent pores 910 towards secondary chamber 427, without releasing any air from the secondary chamber 427 in the opposite direction due to the porous vent pores 910 at the return chamber interface 426 being filled with blood, thereby effectively preventing air flow through the porous vent 910 due to clogged pores. The withdrawal created by the negative pressure within the secondary chamber 427 has a fluid resistance based on the blood filling the vent pores 910 and based on the tortuous path created by the vent pores 910, and therefore is a gradual withdrawal with reduced movement of air. fluid.
[061] At this point, the evacuated collection vessel and the secondary chamber 427 are both in negative pressure with respect to the external environment (and with respect to the patient's bloodstream), and therefore both effect a withdrawal from the blood cannula. fluid inlet 436. This mutual withdrawal effect can essentially establish a balance within return chamber 426, so that blood contained within return chamber 426 is not withdrawn toward or into secondary chamber 427 through vent pores. porous 910 or in the collection vessel evacuated through fluid inlet cannula 436, but instead essentially remains within return chamber 426 in a steady state. The negative pressure of the evacuated collection vessel draws blood directly from the patient through the fluid inlet cannula 436, due to the proximity and alignment of the fluid outlet cannula 452 and the fluid inlet cannula 436, as well as the balance established within the chamber. 426 (based on opposing withdrawal forces between the evacuated collection vessel and the evacuated secondary chamber 427). The continuous withdrawal of blood in the evacuated collection container gradually causes the pressure inside the collection container to increase.
[062] Once the evacuated collection container is filled with the desired amount of blood, the container is removed from the non-patient piercing tip 462, thereby releasing fluid communication between the non-patient piercing tip 462 and the evacuated collection vessel, with sealable sleeve 461 then covering and closing the non-patient piercing tip 462. Absent such withdrawal from the negative pressure of the evacuated collection tube, the negative pressure within secondary chamber 427 effects a slight withdrawal on blood into return chamber 426 through porous ventilation pores 910. Such withdrawal, however, is slow and gradual, due to the tortuous path of blood flow through porous ventilation pores 910.
[063] Additional evacuated collection containers can then be inserted into the tube retainer 800 and used for sample collection through the non-patient piercing tip 462 as described above, by placing a second evacuated collection container inside retainer 800 and establishing fluid communication between the non-patient piercing tip 462 and the interior of the collection container evacuated via cap piercing, as discussed. Yet in such sampling, the evacuated collection vessel and secondary chamber 427 are both at negative pressure, and therefore both effect a withdrawal from the fluid inlet cannula. As above, this effect essentially balances within return chamber 426, thereby preventing contaminated blood within return chamber 426 from being drawn toward or into secondary chamber 427 (through porous vent 910). The negative pressure of the evacuated collection vessel draws blood directly from the patient through fluid inlet cannula 436 as discussed above, due to the proximity and alignment of fluid outlet cannula 452 and fluid inlet cannula 436. Once any additional containers evacuated collection points are filled with the desired amount of blood, the container is removed from the non-patient piercing tip 462, thereby releasing fluid communication between the non-patient piercing tip 462 and the evacuated collection container, with sealable sleeve 461 then covering and closing non-patient piercing tip 462.
[064] Once all the desired blood samples have been taken in this manner, patient piercing tip 438 is removed from the patient's vasculature (i.e., bloodstream), thereby exposing the patient piercing tip opening 438 to the external environment. Since the only communication path between the interior of the housing and the external environment is through the patient piercing tip 438, the negative pressure established within the secondary chamber 427 in relation to the external environment will affect the gradual withdrawal of blood contained in the chamber. 426 and into fluid inlet cannula 436 towards and through porous vent 910. Such withdrawal effect will displace and move any blood contained in fluid inlet cannula 436 away from patient piercing tip 438, in secondary chamber direction 427, thereby preventing any blood from leaking from patient piercing tip 438 out of fluid inlet cannula 436. Such negative pressure within secondary chamber 427 may continue to have a gradual withdrawal effect through ventilation porous 910 for an extended period of time after patient piercing tip 438 is removed from the patient, and can withdraw all remaining blood containing fluid inlet cannula 436 and return chamber 426 through porous vent 910 and/or secondary chamber 427. Needle assembly 410 may then be properly arranged in a known manner.
[065] Figs. 13A, 13B, and 13C further show an embodiment of a needle assembly. The needle assembly shown in Figs. 13A-13C is similar to the assembly described above in connection with Figs. 8-10, 11A, and 11B, although with the secondary chamber still comprising a plurality of interior regions that are in fluid communication with each other, and desirably gas-vented fluid communication, to define the interior volume of the secondary chamber.
[066] In particular, as shown in Fig. 13A, a needle assembly 510 includes a housing 512 having a fluid inlet end or first end 514 and a fluid outlet end or second end 516. Needle assembly 510 further includes a fluid inlet cannula 536 extending extends from first end 514 of housing 512. Fluid inlet cannula 536 extends between an outer end defining a first piercing point such as a tapered bevel in patient piercing point 538, and an inner open end 539 extending inside first end 514 of housing 512, and can be fixedly mounted therein. Fluid inlet cannula 536 is further characterized by a substantially cylindrical lumen extending between the ends and communicating with the interior of housing 512.
[067] Needle assembly 510 also includes a second piercing tip such as a non-patient piercing tip extending from second end 516 of housing 512, such as through a second cannula-shaped cannula outlet 552. In particular, fluid outlet cannula end 552 may define a tapered bevel forming non-patient piercing tip 562. Fluid outlet cannula 552 extends into second end 516 of housing 512, and can be fixedly mounted there. Fluid outlet cannula 552 is further characterized by a substantially cylindrical lumen communicating with the interior of housing 512. Outlet cannula 552 is mounted within housing 512 such that an inner end 564 passes substantially coaxially therein so that the fluid cannula 552 is mounted within housing 512. outlet 552 substantially axially aligns with the inner end of inlet cannula 536, in a similar manner as discussed in connection with the embodiment shown in Figs. 8-10, 11A, and 11B described above. For example, the inner end 564 of outlet cannula 552 may be spaced only a short distance from the inner end 539 of inlet cannula 536, thereby forming an axial clearance therebetween for blood flow in the return chamber 526 around outlet cannula 552 as shown in Fig. 13C, or it may be a single cannula having an opening therein, as described in connection with the embodiment of Figs. 12A-12B.
[068] As shown in Figs. 13A-13C, needle assembly 510 includes a generally elongated longitudinal portion at first end 514, which generally includes an inner wall 515 and an outer wall 517. Inner wall 515 extends generally longitudinally within housing 512, with a first diameter defining an inner chamber in the form of a return chamber 526. Second end 516 defines a second portion having a second diameter that is generally larger than the first diameter of inner wall 515. Inner wall 515 is sized to provide a radial clearance around the cannula. outlet 552 of about 0.2 mm in an area surrounding its inner end 564, thereby obtaining substantially laminar blood flow within return chamber 526, as discussed above. Inner end 564 of outlet cannula 552 may be supported within housing 512, as in the embodiment discussed above. Needle assembly 510 may further include a sealable sleeve 561 mounted to fluid outlet end 516 of housing 512, such as through a mounting boss 529, as discussed above.
[069] As with the realization of Figs. 8-10, 11A, and 11B, needle assembly 510 further includes a porous vent 910a positioned within housing 512. Porous vent 910a is generally a cylindrical member with a central opening axially spaced therefrom and encircling a portion of the cannula, particularly the cannula. fluid outlet 552. Porous vent 910a may be constructed of any suitable material as described above in connection with the embodiment of Figs. 8-10, 11A, and 11B. Porous vent 910a is positioned within housing 512 in a manner such that housing 512 is divided into at least two distinct chambers, e.g. a first chamber represented by return chamber 526 and a second chamber representing the total internal volume of housing 512 which is positioned downstream of porous vent 910a. The term downstream is used herein to represent location with respect to the intended flow of blood through needle assembly housing 512 510, i.e., blood flows through housing 512 from patient piercing tip 538 into needle cannula. fluid inlet 536, through open end 539, into the return chamber 526, into the porous vent 910a, and into the secondary chamber.
[070] Porous vent 910a may be positioned within housing 512 at a location extending the transition between the first end 514 and second end 516. The interior volume of housing 512 is defined by the sum of the volumes of the return chamber and the secondary chamber as well as the volume represented by the porous ventilation pores 910a. Such an interior volume is configured so as to provide certain attributes for the needle assembly 510, in particular with respect to the ability of the secondary chamber to be at least partially evacuated of a portion of the air contained therein to establish a negative pressure therein with application of a evacuated tube to the needle assembly 510 during its use, as described in connection with the embodiments shown above. Such negative pressure within the secondary chamber draws blood into the vent pores 910a based on when blood contacts the vent vent 910a at the vent vent 910a interface and return chamber 526 and partially fills its pores.
[071] In the realization of Figs. 13A-13C, the secondary chamber comprises a plurality of distinct interior regions, such as a first interior region 527a and a second interior region 527b. In particular, in carrying out Figs. 8-10, 11A, and 11B, secondary chamber 427 represents a radially enlarged portion at second end 416 of housing 412, which enlarged portion accommodates the proper size of porous vent 910 and adequate internal volume required for secondary chamber 427 to function in the manner intended (i.e., to represent a substantial volume of the total interior volume of housing 512 so as to be able to establish negative pressure therein during use, as described above). When used in connection with traditional blood collection needle assemblies, it is desirable to maintain a low profile for the assembly. This can be accomplished by providing a reduced overall profile, and in particular a reduced overall diameter, of the secondary chamber.
[072] In order to maintain the appropriate secondary chamber volume for the intended use, the secondary chamber may extend longitudinally along the housing 510. It is important, however, to ensure that there is sufficient volume between the secondary chamber and the vent pores. porous 910a in order to ensure a sufficient withdrawal effect once the secondary chamber is evacuated to its intended use. Likewise, the secondary chamber can be divided into a plurality of regions, as in the embodiment of Figs. 13A-13C, in which the secondary chamber includes first interior region 527a and second interior region 527b, with first and second interior regions 527a, 527b in fluid communication with each other through porous ventilation 910a, and also in fluid communication with respect to the return chamber 526 downstream of return chamber 526. In this way, the total volume of the secondary chamber downstream of the return chamber, which is constituted by a plurality of interior regions separated by porous ventilation, is sufficient to obtain the intended use of the return chamber. device described herein, by maintaining the secondary chamber as a significant amount of the total volume of the needle housing.
[073] While the present embodiment shows two interior regions 527a and 527b, it is contemplated that the number of interior regions can be any number as far as the total interior volume of the secondary chamber (represented by the total volume of the combined interior regions downstream of the vent porosa 910a), define a downstream secondary chamber volume corresponding to the volume and ratios described above with respect to the realization of Figs. 8-10, 11A, and 11B.
[074] The first interior region 527a of the secondary chamber may be generally located adjacent to the second end 516 of housing 512, while the second interior region 527b of the secondary chamber may be generally concentrically positioned around a portion of the return chamber 526 This may be accomplished by providing housing 512 as a two-part housing, with first end 514 representing a main body portion 530 of the housing, and second end 515 representing a separate body portion 528 of the housing that can be attached to the housing. main body portion 530 forming housing 512. For example, main body portion 530 of housing may include inner wall 515 defining return chamber 526 and outer wall 517 defining second interior region 527b. Main body portion 530 extends generally along axis defining needle assembly 510 to define an elongate longitudinal portion, with interior wall 515 defining a first diameter for return chamber 526, and exterior wall m517 defining a second diameter for second interior region 527b. Separate body portion exterior wall 528 at second end 516 of housing 512 generally defines first interior region 527a, and exterior wall 517 of main body portion 530 of housing 512 generally defines second interior region 527b. In this manner, the second interior region 527b extends distally from the porous vent 910a longitudinally and annularly surrounding a return chamber portion 526. Desirably, interior wall 515 and exterior wall 517 are transparent or translucent, so that the return chamber contents 526 (such as a blood flow therein) may be visible through second interior region 527b and/or through first interior region 527a.
[075] The outer wall 517 of housing 512 generally tapers from a larger diameter to a smaller diameter in the direction of the first end 514. An outer wall portion 517 shown in Fig. 13B in portion 517p may include a substantially constant diameter for accommodating porous ventilation 910a therein in a hermetically sealed arrangement. Alternatively, porous vent 910a may include dimensions that taper to match the interior wall surface along the tapered exterior wall 517.
[076] Figs. 14-16 further show an embodiment, in which needle assembly 510 is shown in use in connection with a secure blood collection needle assembly, including tube retainer 810 for accommodating an evacuated blood collection tube (not shown) during a standard blood collection procedure in a known manner, and an 812 pivot safety shield for needle protection after use of the blood collection needle assembly.
[077] In use, needle assembly 510 works in substantially the same manner as needle assembly 410 described above in connection with Figs. 8-10, 11A, 11B, 12A, and 12B, with first and second interior regions 527a, 527b acting in the same manner as the secondary chamber 427 described in the previous embodiment. In particular, needle assembly 510 is provided in combination with a tube retainer, such as tube retainer 810. With fluid inlet cannula venipuncture 536 with a patient, blood flows into fluid inlet cannula 536 based on the pressure of patient's blood and out of its open end 539 into the return chamber 526, as shown in Fig. 13A, for visualization of blood flow, but does not fully contact the porous ventilation pores 910a. After flash visualization, an evacuated blood collection container is inserted into the tube retainer 810 for piercing by the non-patient piercing tip 562 of fluid outlet cannula 552, which draws blood from return chamber 526 and draws air from the first and second interior regions 527a, 527b, thereby reducing pressure within return chamber 526 and first and second interior regions 527a, 527b, in a manner as described above. Next, negative pressure within return chamber 526 and first and second interior regions 527a, 527b draws blood from the patient through fluid inlet cannula 536, fully contacting porous vent surface 910a at porous vent interface 910a and chamber return 526 to fill your pores. Once the interior volume within first and second interior regions 527a, 527b has been evacuated, first and second interior regions 527a, 527b represent a closed environment with a negative pressure there, and therefore continue to have a withdrawal effect on the blood. within porous ventilation filled pores 910a and within return chamber 526, as discussed above. Once all tubes are filled and removed, negative pressure is maintained within the first and second interior regions 527a, 527b because the porous ventilation filled pores 910a seal off the first and second interior regions 527a, 527b from the external environment, and such negative pressure within first and second interior regions 527a, 527b continues to effect a gradual withdrawal over blood contained within porous vent pores 910a and return chamber 526 and within fluid inlet cannula 536 away from patient piercing tip 538, thereby preventing any leakage of blood from the patient piercing tip 538. Such continuous withdrawal may cause blood to flow completely through porous ventilation pores 910a and into one or both of the first and second interior regions 527a, 527b.
[078] Reference is now made to Figs. 17 and 21 showing a cross-sectional view of the needle assembly of the invention in accordance with another design, generally denoted 610, and having a porous vent 920 including a blocking member 925 located within a porous vent 920. In this needle design, the needle assembly 610 includes a housing 612 defining an interior of housing 620. The housing includes a first fluid inlet end 614, a second fluid outlet end 616, and an outer wall 618 extending between ends 614 and 616. Housing 612 includes a cylindrical inner wall 624 that extends into housing 620. Outer wall 618 includes a frusto-conical shaped portion 618a that extends toward the first fluid inlet end 614. This frusto-conical shaped portion 618a, the porous vent 920, and the cylindrical inner wall 624 define a return chamber or first chamber 626. The inner wall 624, outer wall 618 of the housing, and a portion of the second fluid outlet end 616 define a second chamber 627. The first chamber 626 and the second chamber 627 are separated by a central opening 628. The housing comprises at least a cannula 632a, 632b, as shown in Fig. 21 having a patient piercing tip 638 extending from a first end 614 of housing 612 and a non-patient piercing tip 662 extending from a second end 616 of housing 612. The non-patient piercing tip 662 extending from a second end 616 of housing 612. -patient 662 and patient piercing tip 638 are in fluid communication with each other within housing 620.
[079] Needle assembly 610 can be assembled according to a drawing as follows. Fluid inlet cannula 632 is positioned through first end 614 of housing 612 so that open inner end 639 is positioned within an interior portion of housing 612 and patient piercing tip 638 extends externally from first end 614. Cannula outlet 652 is positioned within housing 612 through opposite end, so that open inner end 664 is positioned within an inner portion of housing 612 adjacent inner end 639 of fluid inlet cannula 632, with slight clearance therebetween, and with non-patient piercing tip extending externally from second end 616. Fluid inlet cannula 632 and fluid outlet cannula 652 may be affixed thereto in any known manner, desirably through a grade adhesive. medicinal.
[080] This type of needle design assembly is also shown in Figs. 13A-13C showing a first fluid inlet cannula 536 extending from housing 512, comprising the tip
[081] patient piercing tip 538 and a second fluid outlet cannula 552 extending from housing 512, comprising the non-patient piercing tip 562. the first cannula 536 and second cannula 552 are substantially axially aligned within housing 520 and separated from each other by a gap between an inner end 539 of the first inlet cannula 536 and an inner end 564 of the second outlet cannula 552, the gap being in fluid communication with the first chamber 526 of the housing.
[082] It can be appreciated that the alternative design, as discussed in relation to Figs. 12A-12B can be used for the needle assembly shown in Figs. 17 and 21 where a single cannula is secured within housing 612 such that an opening is positioned within housing 612, with patient piercing tip 638 extending externally to first end 614 and non-patient piercing tip 614 662 extends externally to second end 616.
[083] Porous vent 920 is positioned within housing 620 to separate the interior of housing 620 into first chamber 626 and second chamber 627. Porous vent 920 includes pores for passing fluid therethrough from first chamber 626 to the second chamber 627 and the only communication path between the housing interior 620 and the external environment is via the patient piercing tip 638.
[084] The porous vent 920 of the present invention is configured to control the flow of fluid so that fluid flows through it in an axial direction, as specifically shown in Fig. 21. Porous vent 920, as shown in Figs. 18-19, comprises a tubular member having a first end face 930, a second end face 932, and a central portion 934 extending between the first end face 930 and the second end face 932. The tubular member includes an axial orifice 936 configured to surround at least a portion 632b of the at least one cannula 632a, 632b and the blocking member 925 causes fluid (air and blood) to flow along a controlled longitudinal path from the first face of end 930 to central portion 934 along a length L, as shown in Fig. 21, and/or to the second end face 932 of the porous vent 920 and, according to the design shown in Figs. 17 and 21, through a central opening 628 between the first chamber 626 and the second chamber 627 where the central opening 628 is located adjacent the central portion 934 of the porous vent 920.
[085] As illustrated in Fig. 20, when using a porous vent 920a' without the blocking member 925 of the present invention, fluid (air and blood) may enter the porous vent 920a' through either or both of the first end faces 930a' and/or a second end face 932a' of porous vent 920a' and through surface of plug hole and flow out through porous means towards second chamber 627a' along a plurality of radial paths in a random manner along the way of lower strength and subsequently through central opening 628a' separating the first chamber 626a' from the second chamber 627a'. Alternatively, fluid may flow at the seal interface with the plastic hub housings 612a'. The low strength of the porous ventilation means 920a' can result in blood pooling in the second chamber 627a' which exhausts the pressure differential between the interior of housing 620a' and the atmosphere. Consequently, this depleted pressure differential can result in a droplet of blood being expelled from the patient piercing tip (not shown) when an evacuated tube is removed from the non-patient piercing tip (not shown) and the needle cannula 632a' is removed from the patient and exposed to atmospheric pressure due to the greater pressure being present in the hub.
[086] The addition of blocking member 925 to the inside diameter and/or along axial orifice 936 of porous vent 920, in accordance with the present invention and shown in Figs. 18 and 19, prevents fluid from moving radially along the shortest path from the inner diameter to the outer diameter of the porous vent 920. In particular, the present invention causes fluid (blood and air) to flow axially or along the longest path through porous ventilation 920, as shown in Fig. 21, through a controlled length of porous vent means 920 from end faces 930, 932 toward center opening 628 in second chamber 627. Added blocking member 925 creates a longer and more tortuous path through means that improves fluid resistance and helps retain vacuum differential in second chamber 627.
[087] Referring again to Figs. 17-19, the blocking member 925 may comprise a bushing fitted with pressure on the inner surface 938 of the porous vent 920. According to one drawing, the bushing may be a stainless steel cannula cut to the length of the porous vent 920. A example may include a 302 stainless steel cannula of cut gauge 17 press fit as a bushing on the inside diameter of a sintered polyethylene cylindrical porous vent having a pore size range of 7-12 microns. This particular arrangement has been found to have less vacuum decay within the second chamber even after multiple tube withdrawals, reduced blood pooling in the second chamber, reduced bubbling in the return chamber, and reduced blood droplet occurrences. Other examples of bushings include extruded plastic tubes and tubular molded parts. Other blocking members for 925 may include potting an annular space between the porous vent 920 and the at least one cannula 632 with an adhesive or sealant or blocking an end face 930, 932 of the porous vent 920 or any other location of porous vent 920 to limit the fluid flow path from first chamber 626 to second chamber 627 and maximize tortuous flow length and vent resistance. In accordance with yet another design, the blocking member 925 may be formed by melting a portion of the porous vent 920 over the inner surface portion 938 to render this portion non-porous. Fusing the vent 920 may be achieved by heat or ultrasonic friction to the inner diameter portion 938 of the vent 920. In yet another design, the blocking member 925 may be a separate member, such as a plastic tubular member, which is placed in adjacent relationship to the inner surface 938 of the porous vent 920.
[088] Referring again to Figs. 12A-12B and previously discussed in connection with Fig. 21, first and second cannulas 632, 652 may be replaced with a single cannula design. As shown in Figs. 12A-12B , a single cannula 470 extends through housing 412 where the single cannula 470 includes a lumen extending therethrough, a first end comprising the patient piercing tip, a second end comprising the non -patient, and an opening 444 through cannula 470 in the lumen at a location between the first end and the second end providing fluid communication between the cannula lumen 470 and the first chamber 426 of the housing.
[089] With continuous reference to Figs. 12A-12B, the porous vent 910 may be replaced with the porous vent 920 of the invention, including blocking member 925, and may be used in this needle assembly 410. This needle assembly 410 has a housing design 412 where the first end 414 of the housing comprises a first elongated longitudinal portion 419 having a first diameter and the second end of the housing 416 comprises a second portion 421 having a second diameter greater than the first diameter of the first portion 419. In this manner, the first portion 419 of the housing Housing 412 essentially defines first or return chamber 426, and second portion 421 of housing 412 essentially defines secondary chamber 427. The porous vent 920 of the invention may be positioned within housing 412 at a location extending the transition between the first diameter of the first portion 419 and the second diameter of the second portion 421. The porous vent 920 including the blocking member 925 of the The invention causes fluid to flow along a controlled longitudinal path from first end face 930 to one of central location 934 and second end face 932 and subsequently through a central opening 428 opening between first chamber 426 and the second chamber 427.
[090] Referring now to Figs. 22A-22D, the porous vent 920a, 920b, 920c, and 920d, can be used in needle assemblies to separate first chamber 626a, 626b, 626c, and 626d from second chamber 627a, 627b, 627c, and 627d where fluid flows through the first or second end face. In particular, as shown in Fig. 22A, the second end face 932a of the porous vent 920a is blocked so that fluid flows from the first chamber 626a to the rear end of the inner cylindrical wall 624a and from this second end face 932a, through the porous vent 920a and out through first end face 930a into second chamber 627a. In Fig. 22A, housing 612a includes a cylindrical interior wall portion 628a that extends into the axial hole of porous vent 920a in adjacent relationship with the inner surface 938a of porous vent 920a. This cylindrical portion 628a functions as the blocking member to control the flow of fluid within the porous vent 920a. In Figs. 22B-22D, fluid flows from first end face 930b, 930c, 930d along a longitudinal path to second end face 932b, 932c, 932d and exits through this second end face into second chamber 627b, 627c , 627d.
[091] In the drawings shown in Figs. 22B-22D, the housing 612b, 612c, 612d includes a rear hub 680b, 680c, 680d having a cylindrical portion 682b, 682c, 682d in adjacent relationship with respect to the inner surface 938b, 038c, 938d of the porous vent 920b, 920c, 920d. This cylindrical portion 682b, 682c, 682d functions as the blocking member to control the flow of fluid within porous vents 920b, 920c, 920d.
[092] Referring now to Figs. 23A-23B there is shown a needle assembly, generally denoted 710 comprising a housing 712 defining a housing interior 720. The housing comprises at least one cannula 732 having a patient piercing tip 738 extending from a first end. fluid inlet 714 of housing 712 and a non-patient piercing tip n762 extending from a second fluid outlet end 716 of housing 712. The non-patient piercing tip 762 and patient piercing holes 738 are in fluid communication with each other within housing interior 720. Porous vent 920 is positioned within housing 720 separating the housing interior into a first chamber 726 and a second chamber 727. Porous vent includes pores for passage of fluid therethrough from the first chamber 726 to the second chamber 727 and the porous vent 920 is configured to control fluid flow so that the fluid flows in an axial direction through the vent. In this drawing, the housing 712 includes a rear hub 780 having a cylindrical portion 782 extending therefrom and in the first chamber 726 towards the first end 714 of the housing 712 to define a portion of the first chamber 726. communication between the housing interior 720 and the external environment is via the patient piercing tip 738. As discussed in detail above, the porous vent 920 comprises a tubular member having a first end face 930, a second end face 932, and a central portion 934 extending between the first end face 930 and the second end face 932. The tubular member includes an axial hole 936, as shown in Figs. 18, 19, and 23B, configured to encircle at least a portion of the cylindrical portion 782 extending from the rear hub 780. The at least one cannula 732 is located within at least a portion of the cylindrical portion 782. The cylindrical portion 782 extends into porous vent 920 and abuts against inner surface 938, as shown in Figs. 18, 19, and 23B of porous vent 920. This cylindrical portion 782 functions as the blocking member 925 to control the flow of fluid so that it flows along a controlled longitudinal path and subsequently through a central opening 628 between the first member 726 and the second chamber 727. In the drawing shown in Figs. 23A-23B, rear hub 780 and cylindrical portion 782 extending therefrom also block second end face 932 of porous vent 920 to prevent fluid flow through second end face 932.
[093] According to an alternative design, as shown in Fig. 24, rear hub 780a may include a tapered cylindrical member 782a that extends from first chamber 726 toward first end 714 of housing 712 to define a portion of first chamber 726. Fluid, in the form of liquid, and air enters the porous vent. 920 from first end face 930, flows along a longitudinal path therethrough due to the presence of blocking member 925, and exits in second chamber 727 through second end face 932.
[094] It can be appreciated that the needle assemblies shown in Figs. 22A-22D, 23A-23B, and 24 can be used with a single-cannula design, as described above with respect to Figs. 12A-12B, or with a pair of cannulas including a gap between the inner blunt ends as described above with respect to Figs. 13A-13C.
[095] Blocking member 925 may be formed from a variety of processes and/or devices as discussed in detail above, such as from a pressure-fitted bushing on the inner surface of the porous vent, an adhesive located between a inner surface of the porous vent and an outer diameter surface of the cylindrical member 782, 782a, a cast inner surface portion of the porous vent 920, a separate member, such as a plastic member or a wall portion of the housing in adjacent relationship with respect to the inner surface of the porous vent, or any other techniques previously shown for rendering a portion of the porous vent non-porous to control the axial flow of fluid therethrough and to reduce random radial movement of the fluid.
[096] The porous vent and blocking member of the present invention causing fluid to flow along a controlled path through porous venting along a longer path, depending on the form of the porous vent, results in slower vacuum decrease within seconds. needle assembly chamber even after multiple tube withdrawals, reducing blood accumulation in the second chamber, and reduced blood droplet occurrences.
[097] Fig. 25 shows a cross-sectional view of the needle assembly of the invention including the locking member of the invention and showing another embodiment of controlled flow of fluid along the longest path through porous vent 920 where the longest path is in one direction. radial. The needle assembly, generally denoted 1010, includes a housing 1012 having a fluid inlet end or first end 1014 and a fluid outlet end or second end 1016. Needle assembly 1010 includes an outer wall 1018 defining the interior of housing. . Outer wall 1018 extends generally longitudinally at first end 1014 forming a first elongated longitudinal portion 1019 having a first diameter. At the second end 1016, exterior wall 1018 forms a second portion 1021 that has a second diameter that is generally larger than the first diameter of the first portion 1019. The first portion 1019 and the second portion 1021 can be arranged relative to each other in a variety of arrangements as far as they are able to function to transport air therebetween as discussed herein. Needle assembly 1010 further includes a fluid inlet cannula 1036 extending from first end 1014 of housing 1012. Fluid inlet cannula 1036 includes an outer end 1042 that defines a first piercing point such as a tapered bevel in patient piercing tip 1038, and extends into first end 1014 of housing 1012 and can be fixedly mounted thereto. Fluid inlet cannula 1036 is further characterized by a substantially cylindrical lumen extending between the ends and communicating with the interior of housing 1012.
[098] Needle assembly 1010 also includes a second piercing tip such as a non-patient piercing tip 1062 extending from second end 1016 of housing 1012. Fluid outlet cannula 1052 extends within second end 1016 of housing 1012, and may be fixedly mounted therein. Fluid outlet cannula 1052 is further characterized by a substantially cylindrical lumen communicating with the interior of housing 1012. Outlet cannula 1052 is mounted within housing 1012 such that an inner end 1064 passes substantially coaxially therein so that the fluid cannula 1052 is mounted within housing 1012. outlet 1052 aligns substantially axially with the inner end of inlet cannula 1036. The inner end 1064 of outlet cannula 1052 is spaced only a short distance from the inner end 1039 of inlet cannula 1036, thereby forming an axial gap therebetween to blood flow in return chamber 1026 around outlet cannula 1052.
[099] Porous ventilation 920 of Fig. 25 is washer-shaped, so the longest path extends in the radial direction. The first porous vent face 930 and second face 932 920 are arranged to limit the inner surfaces of the first portion 1019 and second portion 1021. The first portion 1019 and second portion 1021 adjacent the porous vent function as the blocking member to control the flow of air. fluid (blood and air) so that it moves along the longest path, which is in a controlled radial direction from an inner portion of the porous vent to the outer circumferential end surface 933 of the porous vent 920, and out in secondary chamber 1027.
[0100] Relative dimensional calculations, volumes and pressures are applied to both illustrated and non-illustrated embodiments of the invention. Likewise, the scope of the invention as defined by the appended claims is not limited to the specific illustrated embodiments. Various other changes and modifications may be made therein by those skilled in the art without departing from the scope or spirit of the invention, and it is intended to claim all such changes and modifications to fall within the scope of the invention.

权利要求:
Claims (27)
[0001]
1. Needle assembly CHARACTERIZED in that it comprises: a housing (212, 312, 412, 512, 612, 712, 1012) defining a housing interior (220, 320, 520, 620, 720), said housing (212 , 312, 412, 512, 612, 712, 1012) comprising at least one cannula (236, 336, 436, 536, 632, 732, 1036) having a patient piercing tip (438, 538, 638, 738, 1038 ) extending from a first end (214, 414, 514, 614, 714, 1014) of the housing (212, 312, 412, 512, 612, 712, 1012) and a non-patient piercing tip ( 462, 562, 662, 762, 1062) extending from a second end (216, 416, 516, 616, 716, 1016) of the housing (212, 312, 412, 512, 612, 712, 1012), the non-patient piercing tip (462, 562, 662, 762, 1062) and the patient piercing tip (438, 538, 638, 738, 1038) being in fluid communication with each other within the housing interior (220, 320, 520, 620, 720); and a porous vent (900, 910, 920) positioned within the housing interior (220, 320, 520, 620, 720) separating the housing interior (220, 320, 520, 620, 720) into a first chamber (226, 720). 326, 426, 526, 626, 726, 1026) and a second chamber (427, 527, 627, 727, 1027), the porous vent (900, 910, 920) including pores for fluid passage therethrough from the first chamber (226, 326, 426, 526, 626, 726, 1026) to the second chamber (427, 527, 627, 727, 1027), said porous vent (900, 910, 920) including a blocking member ( 925) to control fluid flow through porous ventilation (900, 910, 920), wherein the only communication path between the housing interior (220, 320, 520, 620, 720) and the external environment is via the patient piercing tip (438, 538, 638, 738, 1038).
[0002]
2. Needle assembly according to claim 1, CHARACTERIZED in that the porous vent (900, 910, 920) is configured to reduce fluid flow along the shortest and least resistant paths through porous vent ( 900, 910, 920).
[0003]
3. Needle assembly according to claim 1, CHARACTERIZED in that the porous vent (900, 910, 920) comprises a tubular member having a first end face (930), a second end face (932) , and a central portion extending between the first end face (930) and the second end face (930), the tubular member having an axial hole (936) configured to surround at least a portion of the at least one cannula ( 236, 336, 436, 536, 632, 732, 1036).
[0004]
4. Needle assembly, according to claim 3, CHARACTERIZED in that the porous vent (900, 910, 920) is configured to cause said fluid to flow along a controlled longitudinal path from the first face (930) to one of the central portion and the second end face (932) of the porous vent (900, 910, 920) and through a central opening between the first and second chambers (427, 527, 627, 727, 1027) wherein said central opening is located adjacent said central portion of the porous vent (900, 910, 920).
[0005]
5. Needle assembly according to claim 1, CHARACTERIZED in that the porous vent (900, 910, 920) comprises a tubular member having a first end face (930) and a second end face (932) , the tubular member having an axial orifice (936) configured to surround at least a portion of the at least one cannula (236, 336, 436, 536, 632, 732, 1036) and wherein the porous vent (900, 910, 920) ) is configured to cause said fluid to flow along a controlled longitudinal path from the first end face (930) to the second end face (932) in the second chamber (427, 527, 627, 727, 1027). ) through one of the first end face (930) and/or the second end face (932).
[0006]
6. Needle assembly, according to claim 1, CHARACTERIZED in that the porous vent (900, 910, 920) is configured to cause said fluid to flow along a controlled radial path from the first chamber (226, 326, 426, 526, 626, 726, 1026) and an inner surface of the porous vent (900, 910, 920) and out through a circumferential end surface of the porous vent (900, 910, 920) to the second chamber (427, 527, 627, 727, 1027).
[0007]
A needle assembly according to claim 1, CHARACTERIZED in that the blocking member (925) blocks at least a portion of the porous vent (900, 910, 920) to render this portion of the vent non-porous to control the fluid flow through it.
[0008]
A needle assembly according to claim 7, CHARACTERIZED in that the locking member blocks (925) at least a portion of an inner surface (938) of the axial hole (936) surrounding at least a portion of the cannula (236, 336, 436, 536, 632, 732, 1036).
[0009]
9. Needle assembly, according to claim 8, CHARACTERIZED in that the blocking member (925) comprises a pressure-adapted bushing on the inner surface (938) of the porous vent (900, 910, 920) and wherein the bushing comprises one of a steel cannula, an extruded plastic tube, and a tubular molded part having a length substantially equal to a length of the porous vent (900, 910, 920).
[0010]
10. Needle assembly according to claim 8, CHARACTERIZED in that the blocking member (925) comprises one of an adhesive or sealant located between an inner surface (938) of the porous vent (900, 910, 920) and an outer diameter of the cannula (236, 336, 436, 536, 632, 732, 1036) or a member supported against the inner surface (938) of the porous vent (900, 910, 920).
[0011]
11. Needle assembly according to claim 10, CHARACTERIZED in that an end surface of the porous member (900, 910, 920) or a central portion of the porous member (900, 910, 920) is locked with a adhesive material to control fluid flow through porous ventilation (900, 910, 920).
[0012]
A needle assembly according to claim 8, CHARACTERIZED in that the blocking member (925) comprises a molten or molten inner surface portion of the porous vent (900, 910, 920).
[0013]
13. Needle assembly according to claim 1, CHARACTERIZED in that the at least one cannula (236, 336, 436, 536, 632, 732, 1036) comprises a single cannula (336, 470) extending through (212, 312, 412, 512, 612, 712, 1012), said single cannula (336, 470) including a lumen extending therethrough, a first end (214, 414, 514, 614, 714 , 1014) comprising the patient piercing tip (438, 538, 638, 738, 1038), a second end (216, 416, 516, 616, 716, 1016) comprising the non-patient piercing tip (462, 562, 662, 762, 1062), and an opening through the cannula (236, 336, 436, 536, 632, 732, 1036) into the lumen at a location between the first end (214, 414, 514, 614, 714 , 1014) and the second end (216, 416, 516, 616, 716, 1016) providing fluid communication between the cannula lumen (236, 336, 436, 536, 632, 732, 1036) and the first chamber (226, 1036). 326, 426, 526, 626, 726, 1026) of the housing (226, 32 6, 426, 526, 626, 726, 1026), or wherein the at least one cannula (236, 336, 436, 536, 632, 732, 1036) comprises a first cannula (236, 336, 436, 536, 632 , 732, 1036) extending from the housing (212, 312, 412, 512, 612, 712, 1012) and comprising the patient piercing tip (438, 538, 638, 738, 1038), and a second cannula (236, 336, 436, 536, 632, 732, 1036) extending from the housing (212, 312, 412, 512, 612, 712, 1012) and comprising the non-patient piercing tip (462, 562, 662, 762, 1062), the first cannula (236, 336, 436, 536, 632, 732, 1036) and the second cannula (236, 336, 436, 536, 632, 732, 1036) being aligned substantially in axially within said housing interior (220, 320, 520, 620, 720) and separated from each other by a gap in fluid communication with the first chamber (226, 326, 426, 526, 626, 726, 1026) of the housing (212, 312, 412, 512, 612, 712, 1012).
[0014]
14. Needle assembly, according to claim 1, CHARACTERIZED by the fact that the first chamber (226, 326, 426, 526, 626, 726, 1026) and the second chamber (427, 527, 627, 727, 1027 ) are configured such that upon insertion of the patient piercing tip (438, 538, 638, 738, 1038) into a patient to cause blood flow to the first chamber (226, 326, 426, 526, 626 , 726, 1026) without sealing the porous vent (900, 910, 920), and with the application of a source of negative pressure to said non-patient piercing tip (462, 562, 662, 762, 1062), blood and air are drawn from the first chamber (226, 326, 426, 526, 626, 726, 1026) and air is drawn from said second chamber (427, 527, 627, 727, 1027), thereby establishing a negative pressure within said second chamber with respect to an external environment of the needle assembly and wherein upon removal of the patient piercing tip (438, 538, 638, 738, 1038) from the patient, the negative pressure within the second chamber (427, 527, 627, 727, 1027) is sufficient to prevent blood droplets from being present at the patient piercing tip (438, 538, 638, 738, 1038).
[0015]
15. Needle assembly according to claim 1, CHARACTERIZED in that the blocking member (925) controls the flow of fluid through the porous vent (900, 910, 920) so that the fluid flows in one direction axially through the porous vent (900, 910, 920), wherein the first end (214, 414, 514, 614, 714, 1014) of the housing (212, 312, 412, 512, 612, 712, 1012) comprises a first elongated longitudinal portion having a first diameter and the second end (216, 416, 516, 616, 716, 1016) of the housing (212, 312, 412, 512, 612, 712, 1012) comprises a second portion having a second diameter greater than the first diameter of the first portion.
[0016]
16. Needle assembly, according to claim 15, CHARACTERIZED by the fact that the porous vent (900, 910, 920) is positioned inside the housing interior (220, 320, 520, 620, 720) between the first portion having a first diameter and the second portion having a second diameter at a location spanning a transition point between the first diameter of the first position and the second diameter of the second position.
[0017]
17. Needle assembly according to claim 16, CHARACTERIZED in that the porous vent (900, 910, 920) comprises a tubular member having a first end face (930), a second end face (932) , and a central portion located between the first end face (930) and the second end face (932), the tubular member further including an axial hole (936) configured to surround at least a portion of the cannula, said axial hole (936) defining an inner surface (938), the blocking member (925) being located on the inner surface (938) of the axial hole (936) to block at least a portion of the porous vent (900, 910, 920) to render This portion of the vent is non-porous to cause fluid to flow along a controlled longitudinal path from the first end face (930) to one of the central locations and the second end face (932) and subsequently through a for central aperture seal between the first chamber (226, 326, 426, 526, 626, 726, 1026) and the second chamber (427, 527, 627, 727, 1027).
[0018]
18. Needle assembly according to claim 17, CHARACTERIZED in that the blocking member (925) is selected from the group consisting of a pressure-adapted bushing on the inner surface (938) of the porous vent (900, 910, 920); an adhesive or sealant located between an inner surface (938) of the porous vent (900, 910, 920) and an outer diameter of the cannula (236, 336, 436, 536, 632, 732, 1036); a fused inner surface portion of the porous vent (900, 910, 920); and a member positioned adjacent the inner surface (938) of the porous vent (900, 910, 920).
[0019]
19. Needle assembly according to claim 1, CHARACTERIZED in that a porous vent (900, 910, 920) includes an axial hole that is positioned within the housing interior (220, 320, 520, 620, 720 ) separating the housing interior (220, 320, 520, 620, 720) into a first chamber (226, 326, 426, 526, 626, 726, 1026) and a second chamber, wherein the axial hole surrounds at least one portion of the at least one cannula (236, 336, 436, 536, 632, 732, 1036), the porous vent (900, 910, 920) including pores for passing fluid therethrough from the first chamber (226, 326 , 426, 526, 626, 726, 1026) for the second chamber, wherein the axial hole (936) surrounds at least a portion of the at least one cannula (236, 336, 436, 536, 632, 732, 1036), the porous vent (900, 910, 920) including pores for passage of fluid therethrough from the first chamber (226, 326, 426, 526, 626, 726, 1026) to the second chamber (427, 527, 627, 727, 1027) ; and a blocking member (925) located adjacent to or within the axial orifice (936) of said porous vent (900, 910, 920), said blocking member (925) is configured to control fluid flow so that fluid flows in an axial direction along a longitudinal path through porous ventilation (900, 910, 920).
[0020]
20. Needle assembly according to claim 19, CHARACTERIZED in that the blocking member (925) is selected from the group consisting of a pressure-adapted bushing for the inner surface (938) of the porous vent (900, 910) , 920), an adhesive located between an inner surface (938) of the porous vent (900, 910, 920) and an outer diameter of the cannula (236, 336, 436, 536, 632, 732, 1036), a surface portion fused inner surface of the porous vent (900, 910, 920), and a member positioned adjacent to the inner surface (938) of the porous vent (900, 910, 920).
[0021]
21. Needle assembly, according to claim 19, CHARACTERIZED in that the locking member (925) comprises a pressure-adapted bushing within the axial orifice of the porous vent (900, 910, 920) and wherein the bushing is formed from a material selected from the group consisting of metal, plastic, composite, and a combination thereof, or wherein the locking member (925) comprises a cylindrical member extending from a portion of the housing (212, 312) , 412, 512, 612, 712, 1012) for the porous vent (900, 910, 920) and adjacent to the inner surface (938) of the porous vent (900, 910, 920).
[0022]
22. Process of preventing blood leakage from a patient needle tip in a needle assembly CHARACTERIZED in that it comprises: a) receiving blood through a patient piercing tip (438, 538, 638, 738, 1038) and to a first chamber (226, 326, 426, 526, 626, 726, 1026) of a needle assembly, the needle assembly comprising: i) a needle housing (212, 312, 412, 512, 612 , 712, 1012) defining a housing interior (220, 320, 520, 620, 720), said housing (212, 312, 412, 512, 612, 712, 1012) comprising at least one cannula (236, 336, 436, 536, 632, 732, 1036) having a patient piercing tip (438, 538, 638, 738, 1038) extending from a first end (214, 414, 514, 614, 714, 1014) of the housing (212, 312, 412, 512, 612, 712, 1012) and a non-patient piercing tip (462, 562, 662, 762, 1062) extending from a second end (216, 416, 516 , 616, 716, 1016) of the housing (212, 312, 412, 512, 12, 712, 1012); eii) a porous vent (900, 910, 920) positioned within the housing interior (220, 320, 520, 620, 720) and separating the housing interior (220, 320, 520, 620, 720) in a first chamber (226, 326, 426, 526, 626, 726, 1026) and a second chamber (427, 527, 627, 727, 1027), with the non-patient piercing tip (462, 562, 662, 762, 1062 ) and the patient piercing tip (438, 538, 638, 738, 1038) being in fluid communication with each other within the first chamber (226, 326, 426, 526, 626, 726, 1026) so that the only communication path between the housing interior (220, 320, 520, 620, 720) and the external environment is through the patient tip piercing tip (438, 538, 638, 738, 1038), the porous ventilation ( 900, 910, 920) including pores for passing blood and air therethrough from the first chamber (226, 326, 426, 526, 626, 726, 1026) to the second chamber (427, 527, 627, 727, 1027), said porous ventilation (900, 910, 920) including a member (925) to control the flow of blood and air through the porous ventilation (900, 910, 920); b) establish fluid communication between the non-patient piercing tip (462, 562, 662, 762, 1062) and a source of negative pressure so that blood contained within the first chamber (226, 326, 426, 526, 626, 726, 1026) is withdrawn from the non-patient piercing tip (462, 562, 662, 762, 1062). ) and air is drawn from the second chamber (427, 527, 627, 727, 1027) through the porous vent (900, 910, 920), thus establishing a negative pressure within the second chamber (427, 527, 627, 727). , 1027) in relation to the external environment of the needle assembly so that blood flows through the cannula (236, 336, 436, 536, 632, 732, 1036) into the first chamber (226, 326, 426, 526, 626, 726, 1026) and contact porous ventilation (900, 910, 920); and c) drawing blood and air through the pores of the porous ventilation (900, 910, 920) towards the second chamber (427, 527, 627, 727, 1027) based on the negative pressure established within the second chamber (427, 527, 627, 727, 1027) so that blood contained within a lumen of the patient piercing tip (438, 538, 638, 738, 1038) is displaced away from the patient piercing tip (438, 538, 638, 738, 1038) and towards the second chamber (427, 527, 627, 727, 1027) to prevent blood droplets from being present at the patient piercing tip (438, 538, 638, 738, 1038).
[0023]
23. Process, according to claim 22, CHARACTERIZED by the fact that the reception step a) comprises receiving blood through the patient perforation tip lumen (438, 538, 638, 738, 1038) from a current patient blood, and the withdrawal step c) displaces the blood away from the patient piercing tip (438, 538, 638, 738, 1038) after removing the patient piercing tip (438, 538, 638). , 738, 1038) from the patient's bloodstream, the process including an additional step after step b) and before step c) comprising releasing fluid communication between the non-patient piercing tip (462, 562, 662, 762). , 1062) and the negative pressure source.
[0024]
24. Process according to claim 22, CHARACTERIZED in that the porous vent (900, 910, 920) comprises a tubular member having a first end face (930) and a second end face (932), the tubular member further including an axial hole (936) configured to surround at least a portion of the cannula (236, 336, 436, 536, 632, 732, 1036), said method including rendering the inner surface (938) of the hole non-porous (936) to cause fluid to flow along a controlled longitudinal path through the porous vent (900, 910, 920) and subsequently to the second chamber (427, 527, 627, 727, 1027).
[0025]
25. Process according to claim 22, CHARACTERIZED in that the porous vent (900, 910, 920) is configured to cause said fluid to flow along a controlled radial path from the first chamber (226 , 326, 426, 526, 626, 726, 1026) and an inner surface of the porous vent (900, 910, 920) and out through a circumferential end surface of the porous vent (900, 910, 920) to the second chamber (427, 527, 627, 727, 1027).
[0026]
26. Process according to claim 23, CHARACTERIZED in that it includes positioning said locking member (925) within the inner surface (938) of the axial hole (936) to render this inner surface non-porous.
[0027]
27. Process according to claim 26, CHARACTERIZED in that the blocking member (925) is selected from the group consisting of a pressure-adapted bushing for the inner surface (938) of the porous ventilation (900, 910, 920). ), an adhesive or sealant located between an inner surface (938) of the porous vent (900, 910, 920), an outer diameter of the cannula (236, 336, 436, 536, 632, 732, 1036), a surface portion fused inner surface of the porous vent (900, 910, 920), and a separate member positioned adjacent to the inner surface (938) of the porous vent (900, 910, 920).

类似技术:

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EP2921112B1|2018-06-13|

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JP5687775B2|2015-03-18|

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EP2716218A1|2014-04-09|

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CN103402429A|2013-11-20|

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WO2012105968A1|2012-08-09|

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US20140052022A1|2014-02-20|

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AU2011357736B2|2015-04-02|

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EP2670306B1|2014-11-12|

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JP2014507220A|2014-03-27|

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CA2826064A1|2012-08-09|

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CN103402429B|2015-07-29|

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ES2529773T3|2015-02-25|

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US8603009B2|2013-12-10|

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EP2716218B1|2015-05-20|

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BR112013019708A2|2016-10-18|

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RU2581716C2|2016-04-20|

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EP2921112A1|2015-09-23|

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EP2670306A1|2013-12-11|

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US9167996B2|2015-10-27|

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RU2013140282A|2015-03-10|

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ES2545409T3|2015-09-10|

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MX2013008841A|2014-08-01|

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BR122014002630B1|2021-08-10|

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US20110178427A1|2011-07-21|

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ES2687192T3|2018-10-24|

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法律状态:
2017-02-07| B08F| Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]|

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2017-05-09| B08G| Application fees: restoration [chapter 8.7 patent gazette]|

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2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-12-03| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-07-06| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|

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2021-11-23| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2022-02-01| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 02/02/2011, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO. |

优先权:

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申请号 | 申请日 | 专利标题

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US13/018,740|2011-02-01|

---

US13/018,740|US8603009B2|2008-03-07|2011-02-01|Flashback blood collection needle|

---

PCT/US2011/023423|WO2012105968A1|2011-02-01|2011-02-02|Flashback blood collection needle|BR122014002630-7A| BR122014002630B1|2011-02-01|2011-02-02|NEEDLE ASSEMBLY|