WO2014005058A1

WO2014005058A1 - Novel auto-aspirating syringe

Info

Publication number: WO2014005058A1
Application number: PCT/US2013/048645
Authority: WO
Inventors: Clark B. Foster; David J. Mishelevich
Original assignee: Aubrey Group, Inc.
Priority date: 2012-06-28
Filing date: 2013-06-28
Publication date: 2014-01-03

Abstract

Disclosed are devices for obtaining fluid samples from living creatures. The auto-aspirating syringes are configured with spring such as an elastic band acting as spring pulling back the syringe piston and creating a vacuum at the time of use to draw blood or other fluid into the syringe. Once the spring is energized by pressing the piston into the syringe or stretching it into a stretched state, movement is initiated by disengaging a catch on the piston from a catch pocket in the syringe cylinder wall. In one version the auto-aspirating device is used in conjunction with a holder with forward and reverse facing needles such that the device can be used either employing multiple single syringes to obtain fluid samples or a single syringe is used multiple times with transfer of fluid to other containers in between uses, auto-aspirating syringe vacuum level or additive contents can vary.

Description

TITLE

NOVEL AUTO-ASPIRATING SYRINGE

CROSS REFERENCE TO RELATED APPLICATIONS

United States provisional application number 61/665,806 dated June 28, 2012 the contents of which are hereby incorporated by reference.

INCORPORATION BY REFERENCE

All publications, including patents and patent applications, mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication was specifically and individually cited to be incorporated by reference.

FIELD OF THE INVENTION

Described herein are systems and methods for obtaining fluid samples from a patient.

BACKGROUND OF THE INVENTION

Vacutainer® systems for withdrawal of blood samples from patients have been effective for decades, the invention by Joseph Kleiner being patented in 1949 (U.S. Patent 2,460,641, "Blood Collecting Apparatus"). Sample containers with pre-established vacuum, however, are both costly and can potentially lose their vacuum over time. One device previously allowed generation of vacuum at the time of use (Haber, TM., Foster, CB, and WH Smedley, U.S. Patent 5,042,403, "Self-Contained. Safety Blood Collection System"), but the manually operated mechanism employed for generating the vacuum is complex requiring a number of parts and associated costs as well as being difficult for the user. It would be desirable to have an easy-to-use, inexpensive unit for drawing blood.

SUMMARY OF THE INVENTION

The invention is an auto-aspirating syringe with vacuum system for drawing fluids from humans or other animals in which the vacuum is easily generated just at the time of the blood drawing. The benefits of the invention are ability of the syringe to be available for operation over a long period of time without concern for leakage of pre-applied vacuum, lower draw rates to mitigate against vein collapse or hemolysis, and low cost. All embodiments can incorporate safety-needle protection although none are illustrated. The base embodiment configurations include (a) a single-use version in which one syringe volume of blood is drawn from the patient, and (b) a multiple-use version in which a double-ended needle is placed in venous communication and multiple containers of blood drawn from the patient are filled or a single auto-aspirating syringe repeatedly used with transfer of fluid to other containers in between uses. The same are applicable to other body fluids.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A, B, C illustrate a syringe with manual generation of vacuum with the elastic band pre-attached at both ends.

FIGS. 2A, B, C show a syringe with manual generation of vacuum with the elastic band only pre-attached at the stem plunger- seal end. FIGS. 3A, B, C, D, E, F, G illustrate a syringe configuration in which multiple vacuum syringes can be employed as sample receivers while only inserting a needle into the patient once or a single vacuum syringe used multiple times to collect fluid that is transferred to other containers.

DETAILED DESCRIPTION OF THE INVENTION

Considerations in making a convenient, inexpensive auto-aspirating syringe obtaining the benefits of vacuum operation are ease of generating the vacuum at the time when it is needed, ability to trigger the operation without disrupting the needle in the vein, and reliability achieved through simplicity.

While the invention relates to the withdrawal of blood, the invention covers other fluids (e.g., pericardial fluid, fluid from thoracentesis, or urine (e.g., from a urinary catheter)) as well. In addition non-medical applications needing such vacuum withdrawal are covered as well (e.g., sampling fluid in a rubber vessel by piercing its wall). The invention applies to any relevant living being, whether human or animal, and in certain

circumstances is applicable to non-living beings as well (e.g., during post-mortem examinations).

The approach is less costly and provides benefits (such as not being subject to vacuum loss during shipping and storage) over a pre-evacuated collection vessel. Also avoids costly double end needle and holder.

A table of figure-identification numbers follows for reference.

105 Needle

110 Needle Hub

115 Non-Pressurized Volume

120 Stem

125 Stem Plunger Seal

130 Stem Plate

135 Syringe Rim

140 Elastic Band, Fixed Version

150 Elastic Band-Plunger Attachment

155 Elastic Band-Syringe Body Attachment

160 Vacuum

165 Catch Mechanism

170 Stem Catch

175 Stem Catch Pocket

180 Catch-Release Force

185 Energizing Force

190 Vein

195 Blood

240 Elastic Band, Movable Version

250 Elastic Band Hook Loop

255 Elastic Band Pull Tab

257 Elastic Band-Syringe Body Hook Attachment 287 Pull-Tab Force

300 Double-Needle Assembly

305 Forward Needle

310 Reverse Needle

315 Elastomeric Shield Cap

317 Syringe without Needle Assembly

320 Syringe Body, Configuration without Needle

325 Check Valve Septum

335 Ridge Ring

340 Proximal Direction

FIGS. 1A, IB, and 1C illustrate an aspirating syringe with manual generation of vacuum by means of elastic band 140 pre-attached at both ends. The elastic bands disclosed herein act as a type of spring. As such, other types of springs such as those made out of metal, rubber, nitrile, elastomer, or polymer could be used in other embodiments of this invention. In a preferred embodiment the device includes syringe body 100 with syringe rim 135 with fluid aspiration occurring through needle 105 and needle hub 110. Within syringe body 100, is housed stem 120 with stem plunger seal 125 and stem plate 130. The mechanism for generating the vacuum includes catch mechanism 165, stem catch 170 and stem catch pocket 175 with stored energy provided by elastic bands 140, fixed version. Each elastic band 140, fixed version is attached at one end to elastic band- plunger attachment 150 and the other end by elastic band-syringe body attachment 155 that is incorporated in syringe rim 135. In terms of sequence of operation, FIG. 1A shows the as-shipped position, FIG. IB shows the energized mode, and FIG. 1C shows the aspiration of blood into the syringe body.

In FIG. 1A, the a preferred embodiment is shown in an as-shipped position. In some circumstances, depending on the situation, needle 105 would not be included in the as- shipped package but would be provided separately. Stem 120 is shown withdrawn from syringe body 100 (stem plunger seal 125 withdrawn so much closer to syringe rim 135) and each elastic band 140 would be in a relaxed state. With stem 120 withdrawn, and needle 105 not on syringe 100 or not in a vein, space 115 would be a non-pressurized volume. In an alternative embodiment only one elastic band 140 would be included. In FIG. IB, the syringe is shown in its energized position. Engaging Force 185 has been applied to stem plate 130 pressing the stem 120 with stem plunger seal 125 into syringe body 100 forcing air out of needle 105, stretching elastic band 140, fixed version (and its counterpart on the opposite side of the syringe (not fully shown)), compressing catch mechanism 165 as the stem moves distally with stem catch 170 moving into alignment with stem catch pocket 175 allowing stem catch 170 to be caught in stem catch pocket 175.

In FIG. 1C, needle 105 is then introduced through the skin and into fluid contact with the inside of vein 190. Catch release force 180 is then applied to stem catch 170 as shown in FIG. IB releasing it from catch pocket 175. Therefore vacuum 160 is created as stem plunger seal 125 is drawn back distally in syringe body 100 as previously stretched elastic bands 140, fixed version shorten. Catch pocket 175 is placed at a location so that during aspiration it will not provide an open communication between the fluid within syringe body 100 and the outside so that fluid would leak out of any version the auto- aspirating syringe. In practice, elastic bands 140, fixed version will not shorten enough that stem plunger seal 125 will move close enough to syringe rim 135 to allow syringe body 100, configuration with needle 105 to be completely filled with fluid, but catch pocket 175 can be moved closer to syringe rim 135 than shown in FIGS. 1. As with the traditional Vacutainer®, the operator manipulates the needle if necessary until the needle is in the vein, blood flows, and syringe body 100 is filled with the blood 195 sample. Note that if the operator is not able to successfully enter a vein and withdraw blood at that location, needle 105 can be withdrawn. When the device is energized and the tip of needle 105 is exposed to air, stem 120 will be withdrawn automatically from syringe body 100 because of the force of the elastic bands 140, fixed version. A benefit of this invention is that unlike a Vacutainer® that has lost its vacuum in such a situation (and thus must be thrown out and a new one used at the additional cost), the auto-aspirating syringe with its manually generated vacuum can be reenergized by applying energizing force 180 to stem plate 130 while holding syringe body 100 thus compressing catch mechanism 165 and moving stem 120 into syringe body 100 until stem catch 170 engages in stem catch pocket 175. The operator can then repeat the process by inserting needle 105 in alternative location to access a vessel.

In another embodiment there are two stem catch pockets instead of one. Moving the stem catch from the stem catch pocket that is closest to the needle end of the syringe to the one that is furthest from the needle end of the syringe. This allows a small vacuum to be generated to allow assessment of access in a satisfactory vein. The lower vacuum makes it less likely that the bevel of the needle will be sucked against the side of the vein and get occluded. FIGS. 2A, 2B, 2C show an alternative embodiment of the auto-aspirating syringe with manual generation of vacuum that incorporates an elastic band only pre-attached at the stem plunger seal end. In this embodiment, the unit is shipped with the stem 120 with stem plunger seal 125 inserted fully into syringe body 100 which has the benefit of having a significantly smaller shipping footprint.

In FIG. 2A, discloses the device in an as-shipped position. Again, in some

circumstances, depending on the situation, needle 105 would not be included in the as- shipped package but would be provided separately. Stem 120 with its stem plunger seal 125 is shown inserted into syringe body 100. Elastic band, movable version 240 is in a relaxed state with one end connected to plunger attachment 150, hook loop 250 not engaged, and pull tab 255 available at syringe rim 135. Stem 120 is fixed in position inside syringe body 100 because as shipped catch mechanism 165 with stem catch 170 engaged in stem catch pocket 175.

FIG. 2B discloses the device in an energized position. To reach this state from the as- shipped position, the operator pulls on pull tab 255 with pull tab force 287 as shown in FIG. 2A exposing hook loop 250 and draws elastic band 240 over a syringe body hook attachment 257 causing elastic band 240, movable version to be stretched. Because stem catch 170 is engaged in stem catch pocket 175, stem 120 remains inserted into syringe body 100 and the syringe is placed into an energized state.

In FIG. 2C, needle 105 is then introduced through the skin and in fluid contact with the inside of vein 190. Catch release force 180 is then applied to stem catch 170 as shown in FIG. 2B releasing it from catch pocket 175. Therefore vacuum 160 is created as stem plunger seal 125 is drawn back in syringe body 100 as the previously stretched elastic band, movable version 240 shortens. As with the traditional Vacutainer®, the operator manipulates the needle if necessary until the needle is in the vein, blood flows, and syringe body 100 is filled with the blood 195 sample. Note that if the operator is not able to successfully enter a vein and aspirate blood at that location, needle 105 can be withdrawn. When the tip of needle 105 is exposed to air in the energized state, stem 120 will be withdrawn automatically from syringe body 100 because of the force of the elastic band, movable version 240. A benefit of this invention is that unlike a Vacutainer® that has lost its vacuum in such a situation (and thus must be thrown out and a new one used at the additional cost), the auto-aspirating syringe with its manually generated vacuum can be reused by applying energizing force 185 to stem plate 130 while holding syringe body 100 thus compressing catch mechanism 165 and moving stem 120 into syringe body 100 until stem catch 170 engages in stem catch pocket 175. When elastic band hook loop 250 is already engaged with syringe body hook attachment 257 the operator can then repeat the process by inserting needle 105 in alternative location and into fluid communication with a vein.

In an alternative embodiment to the approach in FIG. 2, there could be two elastic bands instead of one. In an alternative embodiment to the approach in FIG. 2, there would be multiple hook loops in the elastic band. If there were, for example, two such hook loops, when only the first was hooked over the syringe body hook attachment 257 and the stem catch 170 were released from stem catch pocket 175, the elastic pull would be less and a lower vacuum created. The lower vacuum generated would avoid collapse of veins in older patients or patients with weaker vein walls. FIGS. 3A-3G illustrate preferred embodiments in which multiple vacuum syringes can be employed as sample acquirers and containers while only inserting a needle into the patient once. Alternatively, a single auto-aspirating syringe with its manually generated vacuum can be used to obtain the blood or other fluid and transfer it to other sample containers. This can be done repeatedly to fill multiple sample containers while only having inserted the needle into the patient once. Because the auto-aspirating syringe, unlike a Vacutainer®, can be reenergized, in an alternative embodiment, only one such syringe need be used to obtain multiple samples and discharge them into separate containers, even through multiple separate containers are used (except for the last sample for which the auto-aspirating syringe with its manually generated vacuum can serve, if desired), such containers would cost significantly less than Vacutainers®.

FIG. 3A illustrates the two-component system, the needle-containing syringe holder 300 and the needleless auto-aspirating syringe assembly 317. Note that while in FIGS. 3, the version of the syringe shown is the one with elastic bands 140, fixed version that is disclosed in FIGS. 1A-1C, an alternative embodiment is one using elastic bands 240, movable version as covered in FIGS. 2. The elements of needle-containing holder 300 include forward needle 305 and reverse needle 310 covered by elastomer shield cap 315. The as-shipped configuration of the needleless auto-aspirating syringe 317 is shown in FIG. 3B with syringe body 320, configuration without needle, containing stem 120 withdrawn from syringe body 320, configuration without needle, with catch mechanism 165 and stem catch 170, located outside syringe rim 135, with stem plate 130 at the proximal end of stem 120. Stem plunger seal 125 is located within syringe body, configuration without needle 320, close to syringe rim 135. Syringe body 320, configuration without needle, is shown with check valve septum 325 and stem catch pocket 175. In the as-shipped configuration shown in FIG. 3B, the elastic band 140, fixed version is attached to stem 120 at elastic band plunger attachment 150 at a distal end and elastic band syringe body attachment 155 part of syringe rim 135 at the proximal end, with elastic bands 140, fixed version relaxed. While in the as-shipped embodiment, the stem plunger seal 125 can be positioned such that stem catch pocket 175 is open to communication to where fluid would be inside syringe body, configuration without needle 320, this would not be true during aspiration. The same is true for the

embodiments in FIGS. 1 and 2.

FIG. 3C shows needleless auto-aspirating syringe with its manually generated vacuum in process of being energized. Energizing force 185 presses stem 120 into syringe body 320, configuration without needle,, stretching elastic bands 140, fixed version. As a result of stem plunger seal 125 moving into syringe body 320, configuration without needle,, air is forced out of check valve septum 325 the detail of which is shown in FIG. 3D. The air being discharged (as shown with the arrows) from syringe body 320, configuration without needle, distends check valve septum 325 away from normal sealing contact with ridge ring 335 as shown in FIG. 3E. Thus check valve septum 325 functions as a one-way valve for air. The relaxed-seal state of valve septum 325 is shown in FIG. 3D.

The fully energized configuration is shown in FIG. 3F. In this configuration, elastic bands 140, fixed version elastic bands 140, fixed version are fully stretched attached at one end at elastic band plunger attachment 150 and elastic band syringe body attachment 155 part of syringe rim 135 at the other. The tensions of elastic bands 140, fixed version are maintained because stem catch 170 is engaged in stem catch pocked 175. FIG. 3G shows aspiration of blood 195 with forward needle 305 of needle-containing holder 300 inserted into the vein 190 and reverse needle 310 (not shown) piercing elastomeric shield cap 315 and check valve septum 325 thus bringing vein 190 and syringe body 320, configuration without needle into fluid communication. Elastomeric shield cap 315 is compressed to expose reverse needle 310. To initiate aspiration, catch release force 180 had been pressed down on stem catch 170 that disengaged from stem catch pocket 175 and allowed stem 120, including now moved stem catch 170, to move in proximal direction 340 out of syringe body 320, configuration without needle, causing vacuum 160 drawing blood 195 into syringe, configuration without needle 320.

In alternative embodiment, the approach of the movable elastic band of the auto- aspirating syringe of FIG. 2 can be used instead of the fixed elastic band of the auto- aspirating syringe of FIG. 1. This would make the as-shipped configuration smaller since the plunger would be fully inserted into the syringe body.

For all the above, an alternative embodiment can be used where there are multiple catch pockets so if the stem catch were to move from a one closer to the needle to one further from the needle, but not released past the syringe rim the stretch in elastic bands will not fully released and the vacuum will be weaker. The lower vacuum generated would avoid collapse of veins in older patients or patients with weaker vein walls. For all of the above, an alternative embodiment can be used where the elastic bands are weaker so the vacuum generated will be lower to avoid collapse of veins in older patients or patients with weaker vein walls. For these alternative embodiments, the sample size obtained could be adjusted or adjustable as well, so either that amount of single sample would have to be sufficient or the multiple- sample approach of FIG. 3 employed.

The elastic bands disclosed herein could be made of rubber, latex, latex-free nitrile, hypo- allergenic materials disclosed in US Patent 5,580, 942 issued to Cornish, or shape memory polymers. The critical features of the material are non-immunogenic and elasticity to create vacuum pressure up to 500mmHg.

While the invention is most likely to be implemented in plastic, other materials (e.g., glass or metal) could be used. Using materials other than plastic would allow autoclaving of the device to facilitate reuse where such reprocessing is economically justified and the elastic bands not damaged during reprocessing. In some embodiments, elastic bands could be replaced if damaged by reprocessing or from repeated use.

In the various embodiments, auto-aspirating syringes with their manually generated vacuum can be coded by one or more of color, pattern, or text for various fluid- sample types such as done for Vacutainers® (e.g., sample containers containing coagulants such as gold or 'tiger' red/black top with additives for serum separation, red top plastic tubes containing a clot activator used when serum is needed, orange of grey /yellow 'tiger" top containing Thrombin, a rapid clot activator, for STAT serum testing, samples containing anticoagulants such as green for those containing Sodium or Lithium Heparin used for plasma determinations in clinical chemistry and purple or lavender containing EDTA, a strong anticoagulant used for Complete Blood Counts, and multiple other such color-coded tubes for various clinical applications). In some cases there can be a differentiation based on the material out of which the sample tube is made. For example, a red-top Vacutainers® plastic tube as noted above contains coagulants while a red top glass tube contains no additives and is used for testing for antibodies and drugs. In some embodiments, an added color strip could be incorporated and in others the auto-aspirating syringe could be made out of glass or other material to differentiate. Just as in Vacutainers®, to differentiate among auto-aspirating syringes having different characteristics such as having weaker vacuums, one or more coding elements such as color, pattern, text, or construction material could be applied to auto-aspirating syringes with their manually generated vacuum with weaker elastic bands to generate weaker vacuums.

For the embodiments shown in FIG. 3, a single auto-aspirating syringe with its manually generated vacuum could be used multiple times, each time expelling a sample into less expensive tubes or other containers. These containers could be filled with various additives such as coagulants or anti-coagulants as needed that could be less expensive than stocking a number of types of the syringes covered by this invention. These separate containers could be coded by one or more of color, pattern, text, material, or other means. It is to be noted that if blood (or other fluids, as applicable) were expelled through check valve septum 325, care in shape would be required to avoid hemolysis. Alternatively, a second double needle holder could be employed to engage check valve septum 325 in the same way as the one in the vein to accommodate discharge into the sample container.

The various embodiments described above are provided by way of illustration only and should not be construed to limit the invention. Based on the above discussion and illustrations, those skilled in the art will readily recognize that various modifications and changes may be made to the present invention without strictly following the exemplary embodiments and applications illustrated and described herein. Such modifications and changes do not depart from the true spirit and scope of the present invention.

Claims

What is claimed is:

1. A fluid sampling device comprising:

a stem (120) traveling in a syringe body (100), a needle (105) connected to the syringe body (100) and fluidly connected to a fluid source, the stem (120) moving under the force of at least one energized spring creating a vacuum (160), and;

the fluid being aspirated from the fluid source into the syringe body (100).

2. The device in claim 1 wherein the at least one spring has two ends and both ends are attached.

3. The device in claim 1 wherein one end of the spring is attached and the device is energized by pulling on an unattached end of the spring into an attached position.

4. The device in claim 1 wherein both ends of the spring are attached and the end of the stem is extended for a substantial portion of its length outside the syringe body for shipping.

5. The device in claim 1 wherein only one end of at least one spring is fixed and a

substantial portion of the length of the piston is inside the syringe body for shipping.

6. The device in claim 1 wherein the device is made from materials selected from the group consisting of rubber, polymer, plastic, glass, and metal.

7. The device in claim 1 wherein the syringe body may contain additive that is

designated to the operator by one of a plurality of indicators selected from the group consisting of color, opacity, pattern, symbol, and text .

8. The device of claim 1 wherein the level of vacuum contained is variable based on a mechanism selected from one or a plurality of the group consisting of spring strength, length of syringe body over which the stem will move, and number of springs.

9. The device of claim 1 wherein the syringe body is equipped with a resealable septum check valve.

10. The device of claim 1 wherein the cylinder syringe body is equipped with a rubber resealable septum check valve and configured with the end of the syringe body fit into a double needle assembly with a forward-facing needle in communication with the fluid source and a reverse-facing needle in communication with the syringe body to allow multiple aspirations without reintroducing the double needle assembly.

11. The device of claim 1 wherein the cylinder syringe body is equipped with a rubber resealable septum check valve and configured with the end of the syringe body fit into a double needle assembly with a forward-facing needle in communication with the fluid source and a reverse-facing needle in communication with the syringe body to allow multiple aspirations without reintroducing the double needle assembly and the mode of operation is selected from the group consisting of multiple single syringe bodies are used to obtain fluid samples and single syringe body is used multiple times with transfer of a fluid sample to a different storage container in between uses.