STERILE SAMPLE INJECTOR AND METHOD
20180164190 ยท 2018-06-14
Inventors
- Amir HADAYER (Beit Hashmonai, IL)
- Noa Hana HADAYER (Beit Hashmonai, IL)
- Arie Leonid MARCOVICH (Rehovot, IL)
Cpc classification
International classification
Abstract
A sterile injector comprises a body having a cavity, a hollow needle positionable at a distal end of the injector, a probe holder receivable within the needle, a probe connected to a distal end of the holder, and a driving element axially displaceable within the cavity, for causing relative motion between the probe and the needle upon displacement of the driving element. A sample is injected into a sealed container by displacing the driving element to a first position causing the probe to extend from the needle, applying the extended probe with a sample, displacing the driving element to a second position causing the sample laden probe to be retracted within the needle, piercing a seal of a sealed container with the needle, and displacing the driving element to a third position distally spaced from the first position, after which the probe is injected into the container interior.
Claims
1. A sterile sample injector for collecting a sample and injecting the same into a sealed container, comprising: a) an injector body having an axially extending cavity; b) a hollow needle with a pointed end which is positionable at a distal end of the injector and configured to pierce a seal of a container; c) a probe and a probe holder which are connected to each other, the probe holder and the probe being receivable within the hollow needle; d) a driving element which is axially displaceable within the axially extending cavity, for causing relative motion between the probe and the hollow needle upon axial displacement of the driving element; wherein the probe is selectively extendable from and retractable into the hollow needle; wherein the injector is configured such that at least the probe is irreversibly ejectable into the container; and wherein the probe is detachably connected to the probe holder or to an extension thereof by one or more engagement elements which are configured such that the probe detaches from the probe holder when the probe holder is distally separated from the pointed end of the hollow needle.
2. The injector according to claim 1, wherein the probe is completely unrestrained by a wall of the hollow needle when the driving element is distally separated from the pointed end of the hollow needle, thereby causing the probe to detach from the probe holder.
3. The injector according to claim 1, wherein the engagement elements comprise one of the following: interengageable hook elements, a concave element in releasable engagement with a circular or spherical element, a tong member, a straight element in releasable engageable with an arcuate hook element, a filament detachably connected to a pin, and an adhesive, or any combination of the aforesaid.
4. The injector according to claim 2, wherein the two interengeageable hook elements comprise a thin element and a terminal element perpendicularly extending from said thin element and arranged such that the thin element of a first hook element is maintained in abutting relation with the terminal element of a second element by a wall of the hollow needle.
5. The injector according to claim 1, wherein the probe is configured to be retractable into the hollow needle.
6. The injector according to claim 1, wherein the probe comprises fluid-absorbable material.
7. The injector according to claim 1, wherein the probe is made of compressible material such to be retractable into the hollow needle and expandable to a thickness greater than the outer diameter of the needle when extending from the hollow needle.
8. The injector according to claim 1, further comprising a manual actuator connected with the driving element for controlling the relative motion between said probe and said hollow needle upon axial displacement of said driving element.
9. The injector according to claim 1, wherein the manual actuator comprises a pin extending into an angled groove formed in a central peripheral portion of the injector body, the pin being guidable within said groove to define a desired axial position of the probe relative to the hollow needle.
10. The injector according to claim 1, further comprising a needle cover which is releasably engageable with the injector body.
11. The injector according to claim 1, wherein the injector body is a hollow cylinder and the driving element is a piston which is axially displaceable within the cylinder, wherein one of the hollow needle and probe holder is attached to the cylinder and one of the hollow needle and probe holder is attached to the piston to cause relative motion between the probe and the needle upon axial displacement of said piston.
12. The injector according to claim 10, wherein the probe holder is attached to a distal end of the piston, the hollow needle is attached to the cylinder, and the pin radially extends from the piston through the groove; or the hollow needle is attached to a distal end of the piston, the probe holder is attached to the cylinder, and the pin radially extends from the hollow needle through the groove.
13. The injector according to claim 1, further comprising a first extension connected to the driving element and a second extension connected to the probe holder.
14. The injector according to claim 1, wherein the probe is detachably connected to the probe holder by a filament which is configured to be torn when the probe holder retracts through a seal of the sealed container.
15. A method for injecting a sample into a sealed container, comprising: axially displacing a driving element within a cavity of an injector body to a first position, thereby causing a probe disposed within a hollow needle to at least partially extend from a pointed end of the needle; applying a portion of the probe which extends from the pointed end with a sample; axially displacing the driving element to a second position, causing the sample laden probe to be retracted within the needle; piercing a seal of a sealed container with the needle; and axially displacing the driving element to a third position distally spaced from the first position and in which third position the probe holder is distally separated from the pointed end of the hollow needle, such that the probe detaches from the sample holder.
16. The method of claim 15, further comprising removing a needle cover from the injector in preparation of transfer of the sample to a culture bottle, wherein removal of the needle cover allows the piercing pierce and penetration of a rubber membrane of the culture bottle for introducing the probe into the culture bottle interior.
17. The method of claim 15, wherein the probe is completely unrestrained by a wall of the hollow needle when the driving element is positioned at the third position, causing the probe to detach from the probe holder.
18. The method of claim 15, comprising prior to axially displacing a driving element within a cavity of an injector body to a first position, taking, with the probe, a biological sample associated with tissue from a living or formerly living entity.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0043] In the drawings:
[0044]
[0045]
[0046]
[0047]
[0048]
[0049]
[0050]
[0051]
[0052]
[0053]
[0054]
[0055]
[0056]
[0057]
[0058]
[0059]
[0060]
[0061]
[0062]
[0063]
[0064]
[0065]
[0066]
[0067]
[0068]
[0069]
[0070]
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0071] Prior art syringe-type injectors allow liquids to be transferred and injected but are unable to reliably transfer non-liquid samples, e.g. for use in microbiological studies. The inability of non-liquid samples to be transferred into a sealed container can be attributed to many factors including, without being bound to any theory, the lack of plasticity of many non-liquid materials that would be needed to induce flowability during air assisted injection, poor sealing and usually increased contamination when a solid sample is desired to be injected since the sealing elements is provided with a standard configuration and will usually not sealingly engage the solid sample, the coalescency of powder samples that would resist flowability during injection, and the increased subatmospheric pressure that needs to be generated in order to draw the sample into the injector.
[0072] The novel injector of the present invention employs an extendable and retractable probe for absorbing a sample and retaining it without contamination prior to being transferred to a culture bottle or any other sealed container.
[0073]
[0074] Probe 16 made of an absorbent or porous material, which also may be a compressible material, is shown to be protruding from needle cover 12 in
[0075]
[0076] The groove formed in the periphery of cylinder 5 has an axially extending portion 6a which extends from a retract position R to an eject position E, an oblique portion distally extending from retract position R, and a transverse portion 6c extending from one end of oblique portion 6b to start position S located between retract position R and eject position E. When actuator pin 7 is guided to one of the positions S, R or E, piston 9 is caused to be correspondingly displaced axially in order to control movement of the probe, as will be described hereinafter.
[0077]
[0078]
[0079] A hollow mounting element 21 having an inwardly sloping wall with a circular cross section extends distally from a central region of distal end 8 of cylinder 5. The inner surface 29 of abutment element 17 is adapted to contact, and to be attached to, the outer surface 31 of mounting element 21 by any suitable attachment means well known to those skilled in the art, including threaded attachment and adhesion. An interface element 33 at the distal end of abutment element 17 is connected to, or integrally formed with, the proximal end of needle 14, and is axially spaced from the distal end 35 of mounting element 21 due to the slope of abutment element 17 and mounting element 21.
[0080]
[0081] Needle cover 12 comprises elongated element 41 adapted to surround needle 14 and to prevent injury as a result of contact with its pointed end, an abutment element enclosure 43, and a thickened portion 44 for engagement with coupling element 19 of cylinder 5, which may be formed with a circumferential recessed shoulder 46. Thickened portion 44 may also be formed with a concave recess 47 for engagement with a convex protrusion 49 at the proximal end of abutment element 17. Abutment element 17 is preferably made of flexible material such as rubber to facilitate engagement with convex protrusion 49. Circumferentially extending elements 18 increase the frictional contact between abutment element 17 and enclosure 43 of cover 12.
[0082] In operation, actuator pin 7 is first set to start position S while needle cover 12 is engaged to abutment element 17, as shown in
[0083] In a second step for transferring a sample, actuator pin 7 is set to retract position R, and the probe is caused to be retracted into the hollow needle, as shown in
[0084] While actuator pin 7 remains at retract position R, the needle cover is then removed from injector 10 in preparation of transfer of the sample to culture bottle 52, as shown in
[0085] In a third step shown in
[0086] In a fourth step shown in
[0087] The detached probe 16 therefore remains in culture bottle 52, as shown in
[0088] In another embodiment of the invention schematically illustrated in
[0089] Injector 60 comprises a probe holder 63 that is fixed to cylinder 65 and releasably connected to probe 66. Probe 66 is received within the interior of hollow needle 64. Elongated hollow needle 64 is positioned by a tight fit within cylinder 65, while allowing relative axial motion relative to the same by means of mode selector actuator pin 67, which is radially connected to the piston, or any other driving element. Mode selector actuator pin 67 radially protrudes from the periphery of hollow needle 64, and is guidable within an angled groove formed within the periphery of cylinder 65. Actuator pin 67 is set to a different position during each step for transferring a sample by means of injector 60, causing relative axial motion between hollow needle 64 and probe 66. Axial displacement of hollow needle 64 therefore causes probe 66 to be positioned distally with respect to pointed end 69 of needle 64, in order to be applied with a sample or to be detached from probe holder 63 within the culture bottle. When it is desired to cause probe 66 to be detached from probe holder 63, needle 64 is proximally displaced to a fullest extent and the probe is caused to contact the culture bottle membrane.
[0090] Injector 60 may also comprise a safety device well known to those skilled in the art to prevent inadvertent axial displacement of hollow needle 64.
[0091]
[0092] Each hook element comprises a thickened connecting portion 81, a relatively thin central portion 82 axially extending from connecting portion 81, and a trapezoidal terminal portion 85 which is laterally and axially spaced from central portion 82. A thickened abutment portion 87 is formed at the end of central portion 82, and a substantially planar surface 88 at the axial end of the hook element laterally extends from abutment portion 87 to terminal portion 85. While an outwardly facing surface 79 of the hook element is substantially straight, an inwardly facing surface 80 thereof is concave and serves as a camming surface with which terminal portion 85 of the other hook element is frictionally engageable. Inwardly facing concave surface 80 extends from connecting portion 81 to the outward end of terminal portion 85 to define a seat 89 for engaging the terminal portion of the other hook element.
[0093] Connecting portion 81 of hook element 71 is attached to the distal end of probe holder 73 and connecting portion 81 of hook element 72 is attached to the proximal end of probe 76. Thus when the piston to which probe holder 73 is attached is proximally displaced, the two hook elements 71 and 72 become interengaged when each terminal portion 85 becomes engaged with the seat 89 of the other hook element, causing probe 76 to be also proximally displaced.
[0094] When probe holder 73 is distally displaced, the two terminal portions 85 become separated as shown. Due to the frictional engagement of terminal portion 85 of hook element 71 with concave surface 80 of hook element 72, the distal displacement of probe holder 73 causes probe 76 to be distally displaced as well. Despite the frictional engagement between terminal portion 85 of hook element 71 with concave surface 80 of hook element 72, terminal portion 85 of hook element 71 is displaced along concave surface 80 of hook element 72 while being increasingly spaced from terminal portion 85 of hook element 72. Abutment portion 87 of hook element 71 is consequently caused to be vertically displaced as a result of the contact of the corresponding terminal portion with upwardly sloping surface 80 of hook element 72. The vertical displacement of abutment portion 87 of hook element 71, as well as that of abutment portion 87 of hook element 72 caused by the proximal displacement of terminal portion 85 of hook element 72 along concave surface 80 of hook element 71, is limited when contacting the inner surface of needle wall 25.
[0095] When probe holder 73 is distally displaced to a fullest extent after needle 14 has been injected into the culture bottle, the abutment portion of hook elements 71 and 72 cease to be confined by needle wall 25. The terminal portions of hook elements 71 and 72 are therefore sufficiently separated to cause probe 76 to be disengaged from probe holder 73.
[0096] Other arrangements for causing the probe to be detached from the injector are also in the scope of the invention. For example, the probe may be adhesively attached to the probe holder by a weak bond which is easily detachable when the probe contacts the culture bottle membrane or seal when the hollow needle is being removed from the culture bottle.
[0097] It will be appreciated that other types of probes may be employed, for example one comprising a plurality of filaments, each of which is made of absorbent or porous material for absorbing the sample, e.g. a biological sample.
[0098]
[0099]
[0100] As shown in
[0101] With reference to
[0102] Groove 115 is provided with three axially separated seats 103, 104 and 105, in each of which actuator 117 is receivable, in order to select a different mode of operation. Actuator 117 is received in seat 104 when displaced to an intermediate position, causing filament 109 to be extended outwardly from needle protector 131. When actuator 117 is received in seat 103 as shown in
[0103] Many other means for releasing a probe into the container are within the scope of the present invention.
[0104] In
[0105] It will be appreciated that the probe may be releasably connected to the probe holder by means of hook elements 138 and 139.
[0106] In
[0107] In
[0108] In
[0109] In
[0110] In
[0111] In
[0112] In another embodiment of the invention shown in
[0113] While some embodiments of the invention have been described by way of illustration, it will be apparent that the invention can be carried out with many modifications, variations and adaptations, and with the use of numerous equivalents or alternative solutions that are within the scope of persons skilled in the art, without departing from the spirit of the invention or exceeding the scope of the claims.