AU611003B2 - Swab transport apparatus - Google Patents

Description

AUSTRALIA

Patents Act COMPLETE SPECIFICATION 6 (0 3

(ORIGINAL)

Class Int. Class Application Number: Lodged: Complete Specification Lodged: Accepted: Published: Priority SRelated Art: i o p APPLICANT'S REFERENCE: St.Amand 9A,9B OM Name(s) of Applicant(s): SAINT AMAND MANUFACTURING, INC.

Address(es) of Applicant(s): San Fernando, California United States of America Address for Service is: PHILLIPS ORMONDE FITZPATRICK Patent and Trade Mark Attorneys 367 Collins Street Melbourne 3000 AUSTRALIA Complete Specification for the invention entitled: SWAB TRANSPORT APPARATUS Our Ref 126690 POF Code: 1602/1602 The following statement is a full description of this invention, including the best method of performing it known to applicant(s): 6003q/1 1 St. Amand 9A,9B Omnibus 1A t lA SWAB TRANSPORT APPARATUS The present invention relates generally to a disposable swab transport apparatus. More particularly, 00oo 0 o o00o the invention concerns an apparatus for obtaining a sample o o 0000 00000 or organisms, such as bacteria, which may be present in or :00 on various parts of the body and preserving the same by 0000 S immersing it within a selected transport medium during 0ooooo 5 0 0 o* 00 transport of the sample to a clinical laboratory for o 0 testing. The transport medium can be added to the apparatus at time of manufacture or, alternatively, "an .000 conveniently be added to the apparatus shortly prir to o o use.

0 10 o 00 0 0.0 Discussion of the Prior Art 0 0 It is frequently necessary for a physician to obtain a o 00 sample of an organism from a patient. As a general rule, 0 15 50 the physician removes a sterile swab from its supply 0 4 package, contacts the area from which the specimen is to be taken and then forwards the swab to a laboratory for testing. Without the exercise of great care during transport, the specimen can become contaminated with foreign particles or organisms and the swab, itself can undesirably spread contamination on route to the laboratory. Further, unless the specimen is maintained in a viable state, such as by treatment of the swab with an appropriate preservative medium, an accurate analysis cannot be obtained.

-2- In the past efforts have been made to provide a disposable swab container within which the transport medium is prepackaged. One such prior art apparatus consists of a two section tube having a swab in one section and a supply of transport medium i the other section. A slotted valve is provided between the two sections to permit the swab to be exposed to the transport medium. Another device consists of a flexible tube having a frangible ampoule in one end, absorbent material adjacent the ampoule and a swab disposed in contact with the absorbent material. In using this device a sample is taken with the swab, the swab is inserted into the flexible walled container and the area 00 oo0 o 'a containing the ampoule is squeezed to break the ampoule.

o0oo 0084 The medium contacts the absorbent material which then 0 0 15 moistens the tip of the swab in contact with the absorbent oooo 0 000 material.

00o Still another prior art device provides a flexible o o 0 0 walled swab enclosure and a closure cap carrying a hollow stemmed swab. A frangible, medium containing ampoule is ooO0 20 mounted in the housing. With this device, after the sample .0 o 00 0 0 is taken, the physician squeezes the housing to fracture the ampoule. The initial squeezing of the housing followed a o°0 by repeated squeezing of the housing pumps the medium in the swab tip. This latter described device is more fully discussed in U.S. Patent No. 3,918,435, issued to Beall et Oo al. Other prior art apparatus for transporting swabs and o specimens is described in U.S. Patent Nos. 3,163,160, 3,282,114, 3,616,265 and 3,674,004.

In most, if not all, of the prior art devices the transport medium is prepackaged within the apparatus, as sold. Accordingly, if different types of transport mediums are required for preserving the different specimens which are to be taken, different apparatus must be purchased and maintained in inventory. Another drawback of the prior art swab transport devices which carry the transport medium during transport and storage is the potential for leakage of the medium from the device and the potential for 3 accidental exposure of the sterile swab to the transport medium prior to the specimen being taken. In either case, the often costly apparatus must be discarded.

The drawbacks of the prior art swab transport devices are uniquely overcome by the apparatus of the present invention which is designed to permit addition of an appropriate transport medium to the apparatus either at time of manufacture or immediately prior to using the apparatus. Further, the apparatus of the invention is uniquely constructed to positively prevent accidental premature exposure of the swab to the transport medium.

00 0 0oo Summary of the Invention 0000 0 0 oooo o 15 It is an object of the present invention to provide a S novel disposable, blow molded swab transport apparatus oo0 having a flexible walled first chamber within which the 00 00 0 0o swab is maintained in a sterile condition and a second chamber in communication with the first chamber which 20 carries the selected transport medium.

Another object of the invention is to provide an o o0 apparatus of the aforementioned character, in which the 0 transport medium is introduced into the swab storage 0 chamber via a circuitous flow path thereby preventing accidental exposure of the swab to the transport medium as o 00o a result of handling and transport of the apparatus.

000 Still another object of the invention is to provide a oO swab transport apparatus as described in the preceding paragraphs in which a specimen of the transport fluid which has been exposed to the contaminated swab can be obtained and separately transported to the laboratory for testing.

A further object of the invention is to provide a swab transport apparatus which includes a swab; a blow molded container having a swab chamber and a transport medium chamber; and a closure cap all of which can be inexpensively manufactured and then assembled together into il 4 a highly compact subassembly which can be easily packaged, used, transported and stored.

Yet another object of the invention is to provide a swab transport apparatus of the class described in which the blow molded container is provided with one or more longitudinally extending flat surfaces which provide a writing surface for inscribing appropriate identification data directly on the device at the time a specimen is taken.

Brief Description of the Drawings 0 0 0 Figure 1 is a front view of one form of the swab 0 0 transport apparatus of the present invention.

00 15 Figure 2 is a side elevational view of the apparatus.

.c0. Figure 3 is a cross-sectional view taken along lines 0 0 0 o°0 3-3 of Figure 1.

Figure 4 is a cross-sectional view taken along lines 4-4 of Figure 2.

20 Figure 5 is a cross-sectional view taken along lines 5-5 of Figure 4. Figure 6 is a cross-sectional view taken along lines oo o 00 o 6-6 of Figure 4.

Figure 7 is a cross-sectional view taken along lines 7-7 of Figure 4.

Figure 7a is a fragmentary view of one end of the apparatus shown in Figure 3 illustrating the appearance of t the device following sealing of the inlet fill tube.

Figure 8 is a front view of another embodiment of the swab transport apparatus of the present invention.

Figure 9 is a side elevational view of the apparatus of Figure 8.

Figure 10 is a cross-sectional view taken along lines 10-10 of Figure 9.

Figure 11 is a cross-sectional view taken along lines 11-11 of Figure ik 5 Figure 12 is a cross-sectional view taken along lines 12-12 of Figure Figure 13 is a front view of still another form of swab transport apparatus of the present invention.

Figure 14 is a side elevational view of the apparatus shown in Figure 13.

Figure 15 is a cross-sectional view taken along lines 15-15 of Figure 14.

Figure 16 is a cross-sectional view taken along lines 16-16 of Figure Figure 17 is a cross-sectional view taken along lines 17-17 of Figure Figure 18 is a cross-sectional view taken along lines 18-18 of Figure 15 Figure 19 is a front view of yet another embodiment of the apparatus of the present invention.

Figure 20 is a side elevational of the apparatus shown in Figure 19.

00 0 0 0 0 0 a a o o o o 0 0 0 000a 0oo0 00o0 0 0oooo 0 00000 0 0 oo 00oo 0 0 o 0 0000 0 0 0 0 0 0 00 0 0 0 0 0 00 00 o oo o o00 Ca0 o ao Figure 21 is a 20 21-21 of Figure Figure 22 is a 22-22 of Figure 21.

Figure 23 is a 23-23 of Figure 21.

Figure 24 is a 24-24 of Figure 21.

Figure 25 is a of the apparatus of Figure 26 is a shown in Figure Figure 27 is a 27-27 of Figure 26.

Figure 28 is a 28028 of Figure 27.

Figure 29 is a 29-29 of Figure 27.

cross-sectional view taken along lines cross-sectional view taken along lines cross-sectional view taken along lines cross-sectional view taken along lines front view of still another embodiment the present invention.

side elevational view of the apparatus cross-sectional view taken along lines cross-sectional vi.-w taken along lines cross-sectional view taken along lines 6 Figure 30 is a cross-sectional view taken along lines 30-30 of Figure 27.

Figure 31 is a front view of yet another embodiment of the apparatus of the present invention.

Figure 32 is a side elevational of the apparatus shown in Figure 31.

Figure 33 is a cross-sectional view taken along lines 33-33 of Figure 32.

Figure 34 is a cross-sectional view taken along lines 34-34 of Figure 33 Figure 35 is a cross-sectional taken along lines 35-35 oo o of Figure 33.

o o0 Figure 36 is a cross-sectional view of another 00oo00 0oo 0 embodiment of the apparatus of the invention wherein the 0~0 15 lower fluid chamber is axially off-set from the chamber 0 oo«o which receives the swab.

0 0 Figure 37 is a cross-sectional view taken along lines o o 37-37 of Figure 36.

Figure 38 is a fragmentary, cross-sectional view of an 00 20 apparatus similar to that shown in Figure 36, but embodying a novel fluid passageway closing mechanism.

0 00 Figure 39 is a fragmentary, cross-sectional view 00 similar to Figure 38, but showing the fluid passageway closing mechanism in a closed configuration.

0 o°o Description of the Invention Goo.00 C 0 Referring to the drawings and particularly to Figures 1 through 7, one form of the swab transport apparatus of the present invention is thereshown and generally designated by the numeral 50. The apparatus of this form of the invention is used for transporting a swab 52 of the character having an elongated stem 54 and a bibulous swab material 56 carried proximate one end of the stem. As best seen by referring to Figures 3 and 4, the apparatus comprises an elon-ited plastic body 58 having resiliently deformable side walls and first and second end portions

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It-- 7 and 61. Body 58 is open proximate its first or upper end and includes a first elongated chamber 62 communicating with the open end for receiving the swab 52.

Body 58 also includes a second chamber 64 having resiliently deformable side walls for containing a fluid therewithin. Second chamber 64 functions as a squeeze bulb, is axially aligned with chamber 62 and is longitudinally spaced therefrom. Disposed intermediate chambers 62 and 64 is a reduced diameter portion 66 which includes a communication path between first and second chambers 62 and 64 provided here as an axially extending passageway 67. Disposed proximate second end 61 of the o00 0 0 0 plastic body is a tubular shaped segment 68 having a fluid 000 passageway 70 therethrough for interconnecting second o 15 chamber 64 with atmosphere.

A removable first cover means is provided for sealably 000000 o0o 0 closing the open first end of body 58. This cover means is 0 0 0 0 0 here provided as a plastic, cup-shaped member 72 having downwardly depending flexible, skirt like, side walls 73 20 adapted to sealably engage the side walls of tubular body 0 0 00o 58 proximate the open upper end 60 thereof. Cap 72 S° includes a central portion 73a which is provided with an axially extending central bore 74 adapted to closely receive the upper end of elongated stem 54 of swab 52.

With this construction, the swab can be removed from the 0° apparatus by gripping the cap member 72 and simultaneously 000- 0 withdrawing the cap and the swab from the body portion 58 oore a 0 in the manner indicated by the phantom lines in Figure 3.

In this way, the sample can be taken without the physician touching any part of the swab itself. After the specimen has been taken, the swab can be reinserted into body 58, once again by handling only cap 72. A downward pressure exerted on cap 72 will cause the skirt, or wall portions, 7? to be received over and closely seal about the walls proximate the open first end 60 of the plastic body 58.

In the embodiment of the invention shown in Figures 3 and 4, it can be seen that body 58 further includes a

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21 n h' safely transported to the clinical nYrug---"llll 8 generally frustoconical shape transition portion 76 disposed intermediate first chamber 62 and reduced diameter portion 66. The lower end of swab portion 56 is partially receivable within this transition portion when cap 72 is fully seated.

In using the apparatus illustrated in Figures 1 through 7, a fluid, such as a transport medium 65 can be added to chamber 64 at the time of manufacture via the open end of body 58 or through use of a syringe assembly with a needle adapted to penetrate the side walls of chamber 64.

Alternatively, the transport medium 65 can be drawn into chamber 64 at any time prior to use by inserting tubular 0 0 0 0 0 segment 6L into a vial containing the fluid, squeezing the 0 C' flexible walls of chamber 64 and then releasing them to 0000 cog, 15 cause the fluid 65 to be drawn into chamber 64 in the 000a 0 manner shown in Figures 3 and 4. Once the transport medium 0 00 t 0 0 most appropriate for use in connection with preserving the 00 0 0 00 0 oo o 0 culture to be taken using the swab 52 is added to chamber 64, tubular segment 68 can be crimped and heat sealed in 0000 20 the manner shown in Figure 7a. This heat sealing step can oo o 0 be accomplished in various ways understood by those skilled 0 0 0 00 in the art and effectively closes off passageway 70 thereby preventing fluid flow through the passageway to the 0 exterior of the apparatus.

After the specimen has been taken by the physician and 0 og the swab re-inserted into the apparatus in the manner shown S in Figures 3 and 4 and with the tube segment 68 sealed in 0 the manner shown in Figure 7a, squeezing the yieldable side i walls of chamber 64 will cause the transport fluid to be injected into the bottom portion of first chamber 62 via passageway 67. Chamber 64 is of a volume such that when the fluid is transferred from chamber 64 into chamber 62, the fluid will substantially encapsulate the bibulous swab material 56 carried by the swab. With the fluid transport medium saturating the bibulous swab material, the entire apparatus can be safely transported to the clinical laboratory for testing.

9 The ability to add the transfer medium to chamber 64 of the apparatus of the invention as depicted in Figures 1 through 7 via tubular segment 68 is particularly important when the selected transfer medium comprises a viscous liquid such as a gel. When such a medium is used it is virtually impossible to add the medium to chamber 64 via the open upper end 58.

Another useful feature of the apparatus of the invention shown in Figures 1 through 7 comprises the provision of a flat portion, or surface, 80 on the body portion 58. As best seen by referring to Figures 1, 2 and portion 80 provides a convenient, smooth writing surface o0 0 for inscribing thereupon appropriate identification data 0 0° 00°° regarding the specimen taken and carried by the swab 52.

1..15 As indicated in the Figures 5, 6 and 7, plastic body oo portion 58 of the apparatus is substantially circular in 000 of oo4 cross-section at any point. As best seen in Figure 6, oo o00 1 reduced diameter portion 66 of the apparatus is reinforced through the provision of transversely spaced, 20 longitudinally extending web portions 69.

Turning now to Figures 8 through 12, another form of 0 00 0 oo the transport apparatus of the present invention is there 00 0shown and generally designated by the numeral 84. The o 0 Sz apparatus of this form of the invention is used for transporting an identically configured swab 52 of the character previously described having an elongated stem 54 and a bibulous swab material 56 carried proximate one end aaao o0 of the stem. As best seen by referring to Figure 10, the apparatus comprises an elongated plastic body 86 having yieldably deformable sidewalls and first and second end portions 88 an d 90. Body 86 is open proximate its first or upper end 88 and includes the first elongated longitudinally extending chamber 92, communicating with the open end for receiving the swab 52.

Body 86 also includes a second chamber 94 having yieldable sidewalls for containing a fluid 65 therewithin.

As best seen by referring to Figure 9, second chamber 94 I i' ill~ IsY.L 10 functions as a squeeze bulb, is axially aligned with chamber 92 and is longitudinally spaced therefrom. Deposed intermediate chambers 92 and 94, is a reduced diameter portion shown here as an intermediate chamber 96. Chamber 96 has flexible side walls and is in communication with chambers 92 and 94 via uniquely arranged fluid passageways presently to be described.

Disposed proximate second end 90 of the plastic body is a tubular shaped segment 98 having a passage way 100 therethrough for interconnecting second chamber 94 with atmosphere. In the drawings illustrating this second embodiment of the invention, tubular segment 98 is shown in 00 o a crimped or sealed configuration. In using the apparatus, 0P0a chamber 94 is filled with an appropriate transfer medium 00 a a prior to the sealing step by placing tubular segment 98 oooo into a reservoir of the selected transport medium and then oooo P o 0 squeezing squeeze bulb or chamber 94 to draw the transport n oo00 0 0 fluid into chamber 94. Once the transport fluid has been drawn into the apparatus, tubular segment 98 is sealed in 000 20 the manner shown in the drawings. It is to be understood 0 0 that, instead of sealing the tubular segment 98, as by heat oo 0 0 DO sealing, segment 98 can be sealed using any type of 00 suitable mechanical clamping device.

o o o 0 A removable first cover means having a configuration identical to that previously described is also provided for 0 00 use in connection with the apparatus of the present form of oO 0 the invention. This cover means, like that of the 0 0VO o 0 previously described embodiment of the invention, comprises a plastic cup-shaped member 72 having downwardly depending flexible sidewalls 73 adapted to sealably engage the sidewalls of tubular body 86 proximate the open upper end 88 thereof. Cap 72 includes the central portion 73 which is provided with an axially extending central bore 74 adapted to closely receive the upper end of the elonateLd stem 54 of the swab 52. With the construction thus described, the swab can be removed, the specimen taken and

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11 the swab reinserted in the manner described in connection with the previous embodiment of the invention.

An important feature of the apparatus of the invention shown in Figure 10 resides in the provision of a circuitous fluid flow path interconnecting intermediate chamber 96 with chamber 94. In the present embodiment of the invention this circuitous fluid flow path comprises transversely spaced, longitudinally extending fluid passageways 102 disposed on opposite sides of chambers 96 and 94 (Figure 10). Proximate the lower extremities of passageways 102 are perpendicularly extending legs or passageways 104 which communicate with the lower extremity S0 of chamber 94. Provided proximate the upper extremities of ~o00 passageways 102, are vertically extending legs or short oo0 15 passageways 106 which communicate with chamber 96 proximate the upper end thereof. As indicated in Figure 10, chamber o0 C 96 communicates with chamber 92 via a centrally disposed 0oo 00 0 axially extending opening 105. With this arrangement, when swab assembly 52 is in position within the apparatus, oo 20 bibulous portion 56 of the swab is received within chamber 0°0 96 and is positioned at a location below the transversely extending passageways 106.

000 In using the apparatus illustrated in Figure 8 through 0~ 12 a fluid such as transport medium 65, if not added at time of manufacture, is drawn into chamber 94 in the manner o oprevious described. Once the transport medium most 00 appropriate for use in connection with preserving the culture to be taken is in place within chamber 94, tubular segment 98 is crimped and heat-sealed as depicted in the drawings. After the specimen has been taken by the physician and the swab is reinserted into the apparatus, squeezing the yieldable sidewalls of chamber 94 will cause the fluid within chamber 94 to be forced through fluid passageways 104 and 102 in the direction shown by the arrows in Figure 10. The fluid will enter chamber 96 via transversely extending legs portions 106 and will saturate the bibulous portion 56 of the swab. It is to be portion being in communication with both said first and second chambers; and -/2 2 12 understood that chamber 94 is of a volume sufficiently large so that the transport medium contained therein can be injected into chamber 96 to substantially fill the chamber so as to completely saturate the bibulous portion 56 of the swab during the time the apparatus is being transported to the laboratory for testing.

As indicated in Figures 11 and 12, chambers 94 and 96 are substantially circular in cross section with longitudinally extending passageways 102 being spaced apart from the axially centerline of the chamber and being carried within transversely extending weblike plastic portions 107 (Figures 8 and :As was the case with the earlier desc::ibed embodiment of the invention, body portion 86 along with tubular 4111 segment 98 is integrally formed by means of a blow molding process using, for example, a suitable blow-moldable plastic material selected from the olefin group.

C.1 0 Turning now to Figures 13 through 18, still another embodiment of the apparatus of the invention is there o 20 shown. Many portions of the apparatus of this form of the a invention are identical to those previously described and the same reference numbers are used to identify components of like construction. For example, as indicated in Figure the cap portion 72 and the swab assembly 52 are of identical construction to that previously described herein save for the fact that swab 52 is provided with a slightly shorter stem and cap 72 is of a slightly larger diameter so as to seaiably engage with the sidewalls of the body portion 110 which also is of a slightly larger diameter than the body portion of the transfer apnaratus previously described.

The apparatus of this further form of the invention includes a longitudinally extending chamber 112 which is in communication with the upper open end portion 114 of body portion 110. Formed proximate the lower portion 116 of the body portion, is a tubular shaped segment 118 which is used to draw an appropriate transport fluid into a second 1 13 chamber 120 of this embodiment of the invention. The tubular segment is then sealed in the manner shown in the drawing. The sidewalls of chambers 112 and 120 are yieldably deformable and function as squeeze bulbs.

Disposed intermediate chambers 112 and 120 is a reduced diameter portion including a third chamber comprising squeezably deformable bulb 122. As best seen in Figure 15, in this form of the invention, chambers 112, 120 and 122 are all axially aligned and are in communication i0 with one another via uniquely arranged fluid passageways of a character presently to be described.

Once again, an important aspect of the apparatus of

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this later form of the invention resides in the provision of a circuitous fluid flow path between chambers 120 and 122. This circuitous flow path prevents the inadvertent premature transfer of the fluid medium 65 from chamber 120 into the swab enclosing intermediate chamber 122 as might

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occur during handling or vibration of the apparatus.

As indicated in Figure 15, the fluid flow path of the device this embodiment of the invention comprises an S axially aligned fluid passageway 124 one end of which communicates with chamber 120 and the other end of which intersects a transversely extending passageway 126. At either end of passageway 126 there is provided longitudinally extending passageways 128 which are located on opposite sides of squeeze bulb 122. Longitudinally extending passageways 128 communicate proximate their upper ends with transversely extending passageway segments 130 which, in turn, communicate with chamber or squeeze bulb 122 proximate the upper end thereof.

In using this latest described form of the apparatus, a fluid such as transport medium 65 is prepackaged with the device, or is drawn into chamber 120 in the manner previously described and tubular segment 118 sealed as shown in the drawings. After the specimen has been taken by the physician and the swab reinserted into the apparatus in the manner shown in Figure 15, squeezing the yieldable r L i r 6003q/1 1 I ii -~rrrrr~ 14 sidewalls of squeeze bulb or chamber 120 will cause the transport fluid to be injected into chamber 122 via passageways 124, 126, 128 and 130. Chamber 120 is of such a volume that when the fluid is transferred from chamber 120 into chamber 122, the fluid will substantially encapsulate bibulous swab material 56 which is disposed within chamber 122. With the fluid transport medium having saturated the bibulous swab material, the entire apparatus can be safely transported to the clinical laboratory for testing.

As indicated in Figures 16, 17 and 18, once again the plastic body portion 110 of the apparatus is shown in these drawings is substantially circular in cross section at any point. It is to be noted that fluid passageways 128 are 15 disposed on opposite sides of chamber 122 and are carried by means of a plastic, flange-like reinforcement 132 I (Figures 13, 15, 17 and 18).

Turning now to Figures 19 through 24, still another 0 form of the apparatus of the invention is there shown.

20 Once again, this form of the apparatus is similar in many 00 0a o0 respects to the apparatus described in the preceding C. 4 ao paragraphs and like numbers are used in the drawings to identify like components. The apparatus here shown 4 comprises an elongated plastic body 140 including longitudinally spaced apart first and second chambers 142 and 144. Plastic body 140 is open proximate its upper end 146 and is provided with a tubular shaped segment 148 proximate its lower extremity 150. Tubular extremity 148 has a fluid passageway 152 which enables communication between 144 and atmosphere.

In the instant form of the invention, tubular section 148, the passageway of which can be sealed by crimping or heat sealing, functions to hold a second cap, or safety shield, 156 in position about the lower squeeze bulb or chamber 144. With this unique construction, when the closure cap 156 is moved from the position shown in the phantom lines in Figure 21 into the position shown in the i.

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001 o 00 o 00 OU 00 O 0 0 Cr000) .04000 0 0 solid lines, tubular section 148 is closely receivable within a centrally disposed aperture 157 formed in safety shield member 156. As the member 156 is snapped into position about the lower end of the apparatus, its upstanding walls surround the squeeze bulb or chamber 144 thereby serving to positively preclude any inadvertent squeezing of the chamber and the resulting accidental injection of the transport medium intu chamber 158.

In using this latter form of the apparatus safety cap 156 is removed, and the appropriate transport fluid drawn into chamber 144 through open passageway 152. After the chamber has been filled and passageway 152 appropriately sealed, safety member or cap 156 is snapped in place thereby surrounding chamber 144 in the manner illustrated in the solid lines of Figure 21.

As was the case with the earlier described embodiments of the invention, this form of the invention also includes an intermediate reduced-diameter portion shown here in the form of a third squeeze bulb or chamber 158. As best seen in Figure 21, chamber 158 is axially off-set and is in communication with first and second chambers 142 and 144 by means of a novel circuitous fluid flow path of a character presently to be described.

Contained within the apparatus of the invention is a 25 removable swab assembly 52 of a configuration virtually identical to that previously described. The upper extremity of swab assembly 52 is receivable within a bore formed in a cap 72 which cap is also of virtually identical construction to the cap used in connection with the previously described embodiments of the invention.

After the specimen has been taken by the physician and the swab reinserted into the apparatus in the manner shown in Figures 19 and 21 and with the cap member 156 closing off passageway 152, squeezing the deformable side walls of chamber 144 will cause the transport fluid 65 to be injected into axially offset chamber 158 via the circuitous fluid path now to be described. Referring to Figure 21, i 16 this circuitous fluid flow path can be seen to comprise a first longitudinally extending fluid passageway 160 which intersects a transversely extending passageway leg 162.

Passageway 162 in turn communicates with a longitudinally extending passageway 164 which communicates proximate its upper end with a short transversely extending passageway leg 166. Passageway 166 terminates at the upper portion of chamber 158. With this construction when the flexible side walls of chamber 144 are squeezed, fluid will be injected into chamber 158 via the circuitous passageway thus described following the path indicated by the arrows in Figure 21. Once again chamber 144 is of a sufficient volume to insure that the bibulous portion of the swab 52 will be fully saturated with the transport medium prior to transport of the apparatus to the clinical laboratory for testing. As was the case with the previous described embodiments of the invention, the unique circuitous fluid o flow path between chambers 144 and 158 prevents accidental transfer of the transport fluid into the swab containing chamber through vibration, shaking or rough handling of the apparatus.

o 0 As indicated in Figures 22, 23 and 24, plastic body 140 is of generally circular cross section at any point.

0 Chamber 158 is also of circular cross section but is axially displaced as indicated in Figure 22. This axially displacement permits the formation of the circuitous passageway with leg 164 of the passageway being .o structurally supported by the transversely extending web 167 (Figures 21 and 23). Lower chamber 144 is also circular in cross section at any point as is second closure cap 156.

Referring now to Figures 25 through 30, yet another form of the swab form apparatus of the present invention is there shown and generally designated with the numeral 170.

The apparatus of this form of the invention is similar in many respects to the embodiments previously described and once again like numbers are used in the drawings to 17 identify like components. The apparatus is used for transporting a swab 52, the stem of which is closely received within a bore formed in a closure cap 72 of a construction identical to that previously described herain.

The apparatus comprises an elongated plasti.c body 172 having an open end portion 174 which is closed by closire cap 72 and a lower portion 176. Body 172 includes a upper elongated flexible-walled chamber 178 and a lower flexible-walled chamber 180. Disposed intermediate chambers 178 and 180 is a reduced diameter portion provided here in the form of a third flexible-walled chamber 182.

Disposed proximate the second end 176 of the plastic body of a tubular shaped. segment 184 having a fluid 0, passageway 186. In the drawings passageway 186 is shown in a sealed condition, segment 184 having been crimped and heat-sealed in a manner previously described. Once again, if desired, a mechanical clamping means can be used to sealably close segment 134.

Chambers 180 and 182 are in fluid communication via a o 20 circuitous fluid path comprising z& longitudinally extending oo elongated fluid passageway 188. Passageway 1.88 is oo 0 4 connected proximate its lower end with a transversely Q0 04 extending passageway 190 which communicates with chamber 0 0 4 S0 180 proximate its lower end. Passageway 188 communicates proximate its upper or opposite end with a transversely extending passageway 192 which in turn communicates with chamber 182 proximate the upper end of this chamber.

o•A highly novel feature of the apparatus of the invention as shown in Figure 27 comprises the provision of a fourth chamber 194. Fourth chamber 19, is in communication with chamber 182 via a fluid passageway comprising a longitudinally extending passageway 196 and a transversely extending passageway 198 which communicates with chamber 182 proximate its lower end. In the present form of the invention, fourth chamber 194 is provided with flexible side walls and is disposed on one side of and in close proximity with chamber 180.

i 18 As best seen by referring to Figures 28, 29 and chambers 178, 180, 182 and 194 are all circular in cross section at any point. Passageway 188 is supported by structural reinforcing web 200.

In using the apparatus illustrated in Figures through 30, a fluid such as a transport medium 65, can be drawn into chamber 180 by inserting tubular segment 184 into a vial containing the fluid, squeezing the walls of flexible chamber 180 and then releasing them to cause the fluid 65 to be drawn into chamber 180 in the manner shown in Figure 27. Once the transport medium most appropriate for use in connection with the culture to be taken is drawn 00 into chamber 180, passageway 186 of tubular segment 184 can 0 40 1 be heat-sealed in the manner previously described so as to 0.t 15 assume the configuration shown in the drawings.

o After the specimen has been taken by the physician and o the swab reinserted into the apparatus in the manner shown 0 in Figure 27, squeezing the yieldable side walls of chamber 180 will cause the transport fluid to be injected into no 20 chamber 182 via passageways 188, 190 and 192. Chamber 180 o o is of a volume such that when the fluid is transferred from o0 0 chamber 180 into chamber 182 the fluid will substantially a encapsulate the bibulous swab material 56 carried by the 0 swab 52. Once the transport fluid has been injected into chamber 182 a small portion of the culture or specimen residing on the swab material will normally be transferred to the fluid transport medium. By squeezing and then releasing the flexible side walls of chamber 194, a part of the transport fluid now contaminated with the specimen will be drawn into chamber 194 via passageways 196 and 198. By severing the length of tube 197 which interconnects chambers 182 and 194, the contaminated transport fluid contained within chamber 194 and designated in Figure 27 by the numeral 65a can be readily separated from the apparatus. After severing tubular segment 197, chamber 194 can be sealed by heat-sealing or otherwise closing passageway 196 of tubular segment 197. Alternatively, 19 segment 197 can first be heat sealed along a portion of its length and then cut through the sealed portion to separate chamber 194 from the device. This sealing and cutting operation can be accomplished in either one or two steps as desired. The contaminated transport fluid contained within chamber 194 can then be safely transported to the clinical laboratory for testing. This unique feature of the apparatus permits clinical testing of the contaminated transport fluid 65a as well as separate clinical analysis of the contaminated swab 52. Testing of the contaminated fluid 65a may be preliminary to testing of the swab or may allow testing of the specimen by a different method.

oTurning finally to Figures 31 through 35, a last Ie 1 embodiment of the invention is thereshown. Many portions of the apparatus of this form of the invention are similar to those described in connection with the apparatus described Figures 13 through 15. However, the relative o. a positioning of the various fluid chambers of the apparatus 4 is somewhat different. The apparatus of this last form of the invention comprises an elongated plastic body portion o o 201 having a longitudinally extending first or upper o a4o chamber 202 and a second longitudinally spaced chamber 204.

Chamber 202 is open proximate its upper end and is adapted 00 to sealably receive a closure member or cap 72 carrying a swab assembly 52 of the character previously described.

Formed proximate the lower portion 206 of body 200 is a tubular shaped segment 208 having a fluid passageway 210 40.4 through which transport fluid can be drawn to fill lower chamber 204. After chamber 204 has been filed with the selected transport fluid medium, tubular segment 208 is heat-sealed in the manner previously described and as indicated in the drawings. Segment 208 can also be sealed using a mechanical clamp if so desired.

Disposed intermediate chambers 202 and 204 is a reduced diameter portion comprising a third flexible-walled elongated chamber 212. As indicated in Figure 33, chambers 202, 204 and 212 are all axially aligned and are in -i ideformable side walls and first and second end portions communication with one another via a novel arrangement of fluid passageways of a character presently to be described.

As best seen by referring to Figures 33 through passageway 210 of tubular segment 208 communicates with chamber 204 via an elongated axially extending fluid passageway 214. Intersecting passageway 214 is a transversely extending passageway 216 which communicates at its outer end with an elongated, longitudinally extending passageway 218 which passageway extends on side of chambers 204 and 212. Proximate the upper extremity of passageway 218 is a transversely extending sub-passageway 220 which communicate with chamber 212 proximate its upper end. In the form of the invention shown in Figure 33, a second, longitudinally spaced sub-passageway 222 is also provided.

This passageway communicates with chamber 212 proximate the oa°f central section thereof. With this arrangement fluid flowing through passageway 218 can enter chamber 212 through sub-passageway 220 as well as through sub-passageway 222. Once again, as indicated in Figures 31 and 33, passageway 218 is structurally supported by a o reinforcing web 224.

o In using this last form of the apparatus, a fluid such as an appropriate transport medium is either prepackaged o with the device or is drawn into chamber 204 in the manner previously described and tubular segments 208 is then clamped or sealed as shown in the drawing. After the 0 specimen has been taken by the physician and the swab o reinserted into the apparatus in the manner shown in Figures 31 and 33, squeezing the yieldable side walls of the squeeze bulb or chamber 204 will cause the transport fluid to be injected into chamber 212 via passageways 216, 218, 220 and 222. Chamber 204 is of such a volume that when the fluid is transferred into chamber 212 the fluid will substantially encapsulate the bibulous swab material 56 of swab 52 which is disposed proximate the lower extremity of chamber 212. With the fluid transport medium having saturated the bibulous swab material, the entire S, L ue seen tnat IDody 58 further includes a "I i I -li yly-r L 21 apparatus can be safely transported to the clinical laboratory for testing.

As indicated in Figures 34 and 35, once again plastic body 200 of the apparatus is substantially circular in cross section at any point as are chambers 204 and 212.

A particular advantage of this last to be described embodiment of the invention resides in the placement of chambers 212 and 204 and their interconnection through the novel circuitous flow path defined by passageways 214, 216, 218, 220 and 222. The location of chambers 204 and 212, coupled with the configuration of the circuitous flow path, positively precludes accidental transfer of the fluid medium from chamber 204 into 212 as a result of handling, shock or vibration of the apparatus of the invention. For example, even through violet shaking of the apparatus of this last form of the invention, the fluid in chamber 204 cannot reach chamber 212. Rather, the transfer of fluid :0'o0 can be accomplished only by positive manipulation of the o 0 flexible outer walls of chambers 204 and 212.

20 Turning to Figures 36 and 37, a further embodiment of 0000 o o the invention is thereshown. Many portions of the 00 0 o 0apparatus of this form of the invention are similar to those described in connection with the apparatus described 2 in Figures 31 through 39. However, the relative positioning of the various fluid chambers of the apparatus is somewhat different. The apparatus of this further form of the invention comprises an elongated plastic body I portion 230 having a longitudinal axis, a longitudinally extending first or upper chamber 232 and a second longitudinally spaced chamber 234. Chamber 232 is open proximate its upper end and is adapted to sealably receive a closure member or cap 72 carrying a swab assembly 52 of the character previously described. It is to be observed that chamber 234 is axially offset from the longitudinal axis of 'chamber 232. Formed proximate the lower portion 236 of body 230 is a tubular shaped segment 238 having a fluid passageway 240 through which transport fluid can be i±aoratory tor testing.

22 drawn to fill lower chamber 234. After chamber 234 has beein filled with the selected transport fluid medium, tubular segment 238 is heat-sealed in the manner previously described. Segment 238 can also be sealed using a mechanical clamp if so desired.

Disposed intermediate chambers 232 and 234 is a reduced diameter portion comprising a third flexible-walled elongated chamber 242. As indicated in Figure 36, chambers 232 and 242 are axially aligned and are in communication with orle another via the open juncture 243 of the chambers.

As best seen by referring to Figure 36, passageway 240 of tubular segment 238 communicates with chamber 234 via an elongated axially extending first fluid passageway 244.

Intersecting passageway 244 is a 'first transversely extending passageway 246 which communicates at its outer .Ogg end with an elongated, longitudinally extending second passageway 248 which passageway extends on the right side oof chamber 234 as viewed in Figure 36. Passageway 248 connects with a second transverse passageway 250 which, in turn, connects with a third longitudinally extending passageway 252, which passageway extends on the left side S.o 00 of chamber 242 as viewed in Figure 36. Proximate the upper extremity of passageway 252 is a third transversely 00 04 o extending passageway 254 which communicates with chamber 242 proximate its upper end. In the form of the invention shown in Figure 36, a fourth transversely extending 0. passageway 256 is also provided. Thi.s passageway communicates with chamber 242 proximate the central section thereof. With this arrangement fluid flowing through A1f 30 passageway 252 can enter chamber 242 through passageway 254 as well as through passageway 256. As indicated in Figures 36 and 37, passageway 248 and 252 are structurally supported by a reinforcing web 258.

The form of the apparatus described in the preceding paragraphs is used in substantially the same manner as the embodiment of the invention shown in Figures 31 through Referring now to Figures 38 and 39, yet another embodiment AS Dest seen Dy reterring to Figure 9, second chamber 94 -23of the apparatus of the invention is there illustrated.

This embodiment of the apparatus is similar in most respects to the apparatus shown in Figures 33 through and only the lower most portions of the apparatus are illustrated in Figures 38 and 39. However, it is to be understood that this form of the invention includes an elongated plastic body portion 201 having a longitudinal axis, a longitudinally extending first or upper chamber 202 and a second longitudinally spaced chamber 204. Chamber 202 is open proximate its upper end and is adapted to sealably receive a closure member or cap 72 carrying a swab assembly 52 of the character previously described (see Figure 33).

Form proximate the lower portion 206 of body 201 is a tubular shaped segment having a fluid passageway 262 therethrough. Integrally formed with segments 260 is the unique closure means of the present invention for blocking 4 flow of fluid from chamber 204 through passageway 216. The details of this closure means will presently be described.

20 Disposed intermediate chambers 202 and 204 is a .Oct o, reduced diameter portion comprising a third flexible walled o0 4 elongated chamber 212 (Figure 33). Chambers 202 and 212 are in communication with one another via the open juncture CO 44 of the chambers.

As best seen by referring to Figures 33 and 38, passageway 262 of tubular segment 260 communicates with chamber 212 via a transversely extending passageway 216 and 0040': a laterally extending passageway 218 (Figure 33).

The closure means of this last embodiment of the apparatus of the invention functions to block the view of fluid from chamber 204 through passageways 262, 216 and 218 toward chamber 212. In the present form of the invention, this closure means comprises a collapsible bellows 264 having a chamber 266 in communication with passageway 262 of tubular segment 260. Bellows 264 includes an upper portion having outwardly sloping first side walls 268 terminating in a generally annular shaped portion 270.

24 Bellows 264 also includes a lower portion having outwardly sloping second side walls 272 terminating in a generally annular shaped portion interconnecting with said first generally annular shaped portion defined by upper walls 268.

Second side walls 272 have an aperture 274 formed therein.

As illustrated in Figures 38 and 39, bellows 264 is movable from a first expanded position as shown in Figures 38 to a second collapsed position as shown in Figure 9 wherein second walls 272 are moved into close proximity with first walls 268.

Also forming a part of the closure means of this embodiment of the invention is an elongated closure plug 276 having first and second ends 278 and 280 respectively.

Plug 276 is removably receivable within aperture 274 of the second side walls of the bellows and is also S, slidably receivable within passageway 262 of tubular segment 260. When plug 276 is removed from the bellows 20 structure as indicated by the phantom lines in Figure 38, o chamber 204 can be filled with a selected transport fluid 0 06 medium. This done, plug 276 is inserted into the bellows assembly in the manner shown in Figure 38 and bonded in a place either by an adhesive or by heat sealing walls 272 in the area of aperture 274. With plug 276 affixed in place within aperture 274, movement of the bellows from the expanded position shown in Figure 238 to the compressed position shown in Figure 39 will cause second end 280 of plug 276 to move upwardly within passageway 262 to a position wherein transverse passageway 216 is blocked so that fluid within chamber 204 cannot flow toward chamber 212.

In using the swab transport device of this latter form of the invention, once the fluid transport medium is added to chamber 204, the bellows can be compressed in the manner shown in Figure 39 moving plug 276 into a position wherein fluid flow through the circuitous passageway leading to 212 25 is positively blocked. With the plug in this position accidental transfer of fluid from chamber 204 to chamber 212 is rendered virtually impossible. When it is desired to positively transfer fluid from chamber 204 through the circuitous pathway into chamber 212 the bellows assembly can once again be expanded to the position shown in Figure 38, and the chambers appropriately manipulated to cause positive f±ow of fluid from chamber 204 into chamber 212 thereby saturating swab 256.

In the preferred form of the invention, the body portion 201, the tubular body segment 260 and the bellows construction are all integrally formed, e.g. of an unsaturated hydrocarbon material selected from the polyolefin group.

Having now described the invention in detail in accordance with the requirements of the patent statutes, those skilled in this art will have no difficulty in making o ochanges and modifications in the individual parts of their O 4 relative assembly in order to meet specific requirements or 20 conditions. Such changes and modifications may be made 0000 without departing from the scope and spirit of the 00 o°0 invention, as set forth in the following claims.

O 0 g _1

Claims (6)

1. 3. Apparatus as in claim i, in which said first and third chambers are axially aligned, and said second chamber is axially offset from said first chamber. L I~L 27
2. 4. Apparatus as in claim 2, in which said first and second chambers are axially aligned and in which said third chamber is axially offset with respect to said first and second chamber. Apparatus as in any one of claims 1-4, further comprising a removable first cover means for sealably closing said open first end of said tube, said first cover means including an axially extending bore for closely receiving a portion of the elongated stem of the swab; and a removable second cover means carried by said tubular segment for surrounding said second chamber to prevent inadvertent deformation of the side walls thereof.
3. 6. Apparatus as in claim 5, in which said second cover means comprises a cup shaped member having curved outer walls and an aperture formed in said walls for closely receiving said tubular segment. 20 7. Apparatus as in claim 2, 4, 5 or 6, in which said second chamber is in communication with said first fluid passageway of said tubular segment and in which said third chamber is in communication with said second chamber via a circuitous passageway having a first transversely extending leg, a second longitudinally extending leg, a second transversely extending leg, a third longitudinally extending leg and a third transversely extending leg, said passageway defining a circuitous fluid flow path. 30 8. Apparatus as in claim 7 in which said circuitous passageway also includes a fourth transversely extending leg in communication with said third longitudinally extending leg.
4. 9. Apparatus as in claim 7 or 8, in which said second transversely extending leg is disposed intermediate said second and third chambers. rll 28 Apparatus as in claim 2, 4, 5 or 6, in which a portion of said circuitous fluid flow path extends parallel to the longitudinal axis of said third chamber and a portion of said circuitous fluid flow path extends perpendicular to the axis of said third chamber.
5. 11. Apparatus as in claim 7, 8, 9 or 10 further comprising closure means carried by said body for closing said circuitous passageway, said closure means comprising: a collapsible bellows having a chamber in communication with said passageway of said tubular segment, said bellows including an upper portion having outwardly So T sloping first side walls terminating in a generally annular 4 shaped portion, and a lower portion having outwardly sloping second side walls terminating in a generally annular shaped port interconnected with said first generally annularly shaped portion of said upper portion, °1 said second side wall having an aperture therethrough, said bellows being movable from a first expanded position wherein said outwardly sloping first walls of said upper o 20 portion are spaced apart from said outwardly sloping second o walls of said lower portion to a second collapsed position wherein said second walls are proximate said first walls; 'J (4 3 and (ii) an elongated plug removably receivable within 25 said aperture of said second side walls of said bellows one 0 end of said plug being slidably receivable within said passageway of said segment and being movable from a first position spaced apart from said circuitous passageway to a second position blocking said circuitous passageway.
6. 12. Apparatus as in claim 11 in which said tubular body segment and said collapsible bellows are integrally formed of an unsaturated hydrocarbon material selected from the polyolefin group. DATED: 16 March, 1989 PHILLIPS ORMONDE FITZPATRICK Attorneys for: SAINT AMAND MANUFACTUNG, INC.y I