WO1995015717A1

WO1995015717A1 - Device for diagnosis and application of pharmaceuticals

Info

Publication number: WO1995015717A1
Application number: PCT/US1993/011803
Authority: WO
Inventors: Linda Zango-Haley
Original assignee: Zango Haley Linda
Priority date: 1993-12-07
Filing date: 1993-12-07
Publication date: 1995-06-15

Abstract

A device for medical diagnostic testing and application of pharmaceuticals such as topical application or supplying measured doses for ingestion includes an elongated stem member (12) with a removable cover (14) enclosing a part of the length of the stem member. The end (24) of the stem member within the cover can be used as a diagnostic testing element or as a pharmaceutical applicator. A seal member (16) on the stem member can maintain the interior of the cover under sterile conditions.

Description

DEVICE FOR DIAGNOSIS AND APPLICATION OF PHARMACEUTICALS

BACKGROUND OF THE INVENTION

The present invention is directed to a device for medical diagnostic testing and for the application of pharmaceuticals, especially topical application. The device includes a stem member, a cover enclosing a part of the stem member and means on the stem member enclosed by the cover for effecting diagnostic testing or the application of pharmaceuticals.

One of the problems with diagnostic testing devices is maintaining the device in a sterile condition until the device is ready for use. After use, if a body fluid or tissue is being tested, the material must be placed in a container and then transported to another location for the actual testing. This requires a multiple number of steps and a multiple number of different elements.

In the topical application and measured dosage of pharmaceuticals it is often necessary to use an applicator to remove the pharmaceutical from a container and then apply it . There is a problem in applying the proper amount and in maintaining the material being applied free of deterioration and contamination. Further, the applicator may not be sterile and may need a considerable amount of work to put it in condition for reuse.

SUMMARY OF THE INVENTION

Therefore, the primary object of the present invention is to provide a simple device for medical diagnostic testing or the application of pharmaceuticals, such as topical application and measured doses, where the device is easy to handle, inexpensive and capable of being maintained in sterile condition until it is ready to be used. Where the invention is employed for diagnostic testing the device can be utilized as a container for the tissue, cells or body fluid to be tested. Further, the device can be structured to carry out the testing procedure.

In accordance with the present invention the device includes an elongated stem member and a cover enclosing a part of the stem member. The cover can be placed in sealed engagement with the stem member with the interior of the cover member providing a sterile environment.

The end of the stem member within the cover can be shaped or formed to carry out the diagnostic testing. The cover can be arranged to contain materials for performing the testing.

For use as a topical applicator, depending on the substance to be applied, a variety of applicator surfaces can be employed on the end of the stem member enclosed by the cover. The substance to be applied can be incorporated in the surface of the applicator or it can be held within the cover and dispensed by the end of the stem member. Though intended primarily for topical application, the applicator can also be used for supplying measured doses of pharmaceuticals for ingestion, such as for children.

In a diagnostic testing device an abrasive surface can be provided on the end of the stem member for removing body tissue to be tested. In addition, a material such as an absorbent material can be secured to the end of the stem member within the cover for taking samples of body fluids to be tested.

The stem member can be shaped to receive an applicator or a testing strip. The testing strip can be formed to carry out fertility tests, for communicable and infectious diseases tests, for drugs of abuse tests, and for environmental tests. Testing strips are formed of a relatively rigid base or support strip, such as a mylar strip on which a membrane tissue containing the testing substance is superposed. Depending on the particular test being performed, the membrane tissue may extend for the full length or for a portion of the length of the mylar strip. In place of the mylar strip, other support materials can be used as long as they are compatible with the testing materials.

Because it is inexpensive to fabricate, the device can be disposable and recyclable.

The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, and the operating advantages attained by its use, reference should be had to the drawing and description matter in which there are illustrated and described preferred embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWING

In the drawing:

Fig. 1 is an elevational view of a diagnostic testing device embodying the present invention;

Fig. 2 is a sectional view of a cover forming a part of the device in Fig. 1;

Fig. 3 is an elevational view of a stem member forming a part of the device in Fig. 1;

Fig. 4 is an elevational view of the stem member of Fig. 3 rotated 90 degrees; Fig. 5 is another embodiment of the stem member of Figs. 3 and 4 to be used as a diagnostic testing device or as a topical applicator;

Fig. 6 is yet another embodiment of the stem member in Fig. 3;

Fig. 7 is a further embodiment of the stem member arranged to receive an insert for use as a diagnostic testing device or as a topical applicator;

Fig. 7a is a perspective view of an insert for use with the stem member of Fig. 7;

Fig. 8 is a seal member forming a part of the stem member illustrated in Fig. 3;

Fig. 9 is an end view of the seal member displayed in Fig. 8 viewed in the direction of the arrow;

Fig. 10 is a sectional view of a wiper useful in a topical applicator; and

Fig. 11 is an end view of the wiper shown in Fig. 10 viewed in the direction of the arrow.

DETAILED DESCRIPTION OF THE INVENTION

A diagnostic testing device 10 is shown in Fig. 1 formed of an elongated stem member 12 and a cover 14 enclosing an elongated part of the stem member 12. The cover member 14 fits in sealed engagement with a seal member 16 on the stem member 12, note Fig. 3.

In the length direction, the elongated stem member 12 is formed of a first section 18 located outside the cover member 14 in Fig. 1 and a second section 20 enclosed within the cover member. The first section 18 acts as a handle for manipulating the stem member and has two flat surfaces 22 for ease in gripping the handle.

Located at the end of the second section 20, adjacent the first section 18, is the seal member 16 shown in more detail in Figs. 8 and 9 and described later. From the seal member 16 to the end 23 thereof remote from the first section, the second section 20 has a reduced diameter and gradually converges to a pair of generally flat sides 24. At least one of the flat sides 24 can be used to support a testing strip, such as a pregnancy test member.

Alternatively, at least one of the flat sides 24 can be provided with a roughened or abrasive surface, such as for removing a tissue specimen from the mouth or from the skin as a dermatological specimen.

Fig. 5 is another embodiment of a stem member 112, such as shown in Figs. 3 and 4, however, with a shorter second section 120. A topical applicator 126 is located on the second section 120 spaced from the seal member 116. The topical applicator 126 can be formed of a foamed plastics material or of an absorbent material for retaining a measured dose of a topical pharmaceutical. Initially, the second section 120 is sealed within the cover, not shown, in a sterile condition assuring the integrity of the topical substance until it is ready to be used. The length of the second section 120 depends on the length required to conveniently apply the topical substance. The applicator can also be used for other than topical application of pharmaceuticals, such as measured doses of a pharmaceutical to be ingested. The applicator can also be used in dentistry, such as for temporary fillings or the application of coating materials for the teeth.

To sterilize the device it can be irradiated, placed in an autoclave, or some other conventional sterilizing means can be used. It can be sterlized before use or, if necessary, after use. In Fig. 6 still another member 212 is displayed having a length dimension similar to the stem member 12 in Figs. 3 and 4. A flocked surface 226 is formed on the end of the second section 220 spaced from the seal member 216. The flocked surface can be used as a topical applicator containing a measured amount of a topical substance. As an alternative the flocked surface 226 could be replaced with an abrasive surface for removing a tissue or cell specimen.

As viewed in Figs. 3, 4 and 6, the device including the stem member and cover may have an overall length of about three inches with the first section being about one-third and the second section being about two-thirds of the length of the stem member. It can be appreciated that the length of the device depends on its intended use, particularly the length of the second section of the stem member for reaching the point of testing or of applying the pharmaceutical.

In Fig. 7 a stem member 312 is illustrated for receiving an insert 340. The insert, forming the second section of the stem member, can be a flat sided member as shown generally in Figs. 3 and 4 for supporting a test strip, such as a fertility or pregnancy test strip and the like. More specifically, as shown in Fig. 7a, the insert 340 includes a base strip, such as a thin relatively rigid mylar strip 342. A membrane tissue 344 is superposed on the strip 342 and contains the testing material. The membrane tissue 344 can extend for the full length of the base strip 342 or it may extend for a part of the length of the base strip from the end remote from the first section of the stem member.

The stem member 312 has a first section 318 forming a handle and a second section 320 including a seal member 316 and an insert holder 330 located within the seal member. A cover member, not shown, would fit over the seal member 316 and have a length sufficient to enclose the insert when it is placed within the holder 330. The insert 340 is fitted into the insert holder 330. After the testing step is completed,

«£CTIFEDSHEET(BULEg,, the cover is placed over the insert, protecting it. In some instances, the testing strip will provide an indication of the test and the test results can be viewed through the cover. In other instances, the device, with the cover enclosing the testing strip, can be sent to a laboratory to complete the test. The combination of the base strip 342 and the membrane tissue 344 can have a thickness in the range of 0.021 inches. The outside surface of the cover can be used to identify the person being tested and any other required information.

As shown in Figs. 3, 4, 5, 6 and 7 the stem member 12, 112, 212, 312 has an annular shoulder 40, 140, 240, 340 forming a bearing surface for the open end 14a of the cover member 14, see Fig. 2. The cover member 14 has an increased diameter section 14b extending in the length direction from the open end 14a. The transition from increased diameter section 14b to a reduced diameter section 14c forms a shoulder 14d arranged to bear against a circumferential edge of the seal member 16f spaced from the first section 18, note Fig. 8.

As illustrated in Fig. 2 at the opposite end 14e from the open end 14a, the cover is closed and has a rounded surface. The opposite end 14e could be flat rather than rounde .

The inside of the cover 14 is dimensioned so that it does not contact the second section of or the insert in the stem member. A testing fluid, topical pharmaceutical, or other type of pharmaceutical can be retained in the cover.

In Figs. 8 and 9 the seal member 16 is displayed on an enlarged scale. Seal member 16 is formed of an elastomeric material so that when the cover 14 is press fitted onto it, the radially outer annular wall 16a forms a seal with increased diameter section 14b of the cover 14. The seal member 16 has a radially inner annular wall 16b joined to the outer wall 16a by an annular disc-like wall 16c extending perpendicularly of the length direction. The disc-like wall 16c is located remote from the first section 18 of the stem member 12. The outer wall 16a is joined to the disc-like wall 16c by a reduced thickness part 16d of the disc-like wall 16c. As a result, the outer wall 16a can pivot or flex inwardly at the part 16d to facilitate the entry of the stem member 12 into the cover 14. In addition, the outer wall 16a tapers slightly outwardly from the disc-like wall 16c to the opposite end 16e of the seal member. The inner wall 16b is open at its opposite ends. The stem member extends through and is sealed by the annular inner wall 16b. In Fig. 9 the seal member 16 is viewed in the direction of arrow A in Fig. 8.

A wiper member 50 is shown in Figs. 10 and 11. It would be located within the cover member 14 inwardly of the shoulder 14d. The wiper member is used with a applicator to wipe excess substance from the applicator or second section of the stem member.

The topical applicator can incorporate the topical substance in an absorbent material or the substance can be filled in the cover. When the topical substance is present in the cover, care must be exercised to hold the cover in a downward position when removing the stem member to avoid loss of the topical substance.

The insert 340 used in the stem member 312 of Fig. 7 can form a curette or scraper at the end spaced from the insert holder 330 for use in taking skin specimens .

A mitt formed of an absorbent material or of brush-like filaments could be fitted onto the end of the second section of the stem member spaced from the first section. The mitt could function as a topical applicator or as a holder of a measured dose of pharmaceutical. To insure the integrity of the seal, before the device is used, a security band could be shrunk fit about the cover 14 and the handle at the transition from the first section 18 to the second section 20 of the stem member 12 to assure that there has been no tampering with the device.

The topical substance or other pharmaceutical can be in liquid, powder, gel or other form.

A sterilizing substance can be incorporated into the cover to insure the interior of the cover remains sterile after a specimen is taken by the stem member and is inserted into the cover.

Though a preferred use of the device is as a topical applicator for pharmaceuticals, persons skilled in the art will appreciate that it can be used as an applicator not limited to topical application.

While specific embodiments of the invention have been shown and described in detail to illustrate the inventive principles, it will be understood that the invention may be embodied otherwise without departing from such principles.

Claims

CLAIMS:

Claim 1. A device for medical diagnostic testing and application of pharmaceuticals including topical application comprising a stem member having a first end and a second end spaced in a length direction of said stem member from said first end, a cover enclosing a part of the length direction of said stem member from the second end to an intermediate location spaced from and between said first and second ends, sealing means located at said intermediate location for providing a seal between said cover and said stem member for maintaining controlled conditions within said cover about the second section of said stem member, said stem member forming a handle part extending from the first end thereof towards said intermediate location for gripping said stem member by a user of the device, one of a diagnostic testing element and a pharmaceutical applicator on the second end of said stem member spaced in the length direction from the intermediate location and being accessible for use only after opening said sealing means and removing said cover.

Claim 2. A device, as set forth in claim 1, wherein said sealing means comprises a seal member positioned on said second section of said stem member at an end thereof abutting said first section, said seal member comprises an annular flexible wall arranged to sealingly contact an inner surface of said cover for a dimension in the length direction, and said flexible wall spaced from the one of said diagnostic testing element and pharmaceutical applicator.

Claim 3. A device, as set forth in claim 2, wherein said flexible wall of said seal member is spaced radially outwardly from an inner annular wall extending generally parallel to said flexible wall, and a connecting wall extending transversely of and interconnecting said flexible wall and inner wall and located at an end of said flexible wall and inner wall, with said stem member extending through said inner wall.

Claim 4. A device, as set forth in Claim 1, wherein said second section of said stem member has a flat surface extending in the length direction at an end thereof remote from said first section.

Claim 5. A device, as set forth in Claim 4, wherein said flat surface is an abrasive surface for use as a diagnostic testing element for removing body tissue to be tested.

Claim 6. A device, as set forth in Claim 4, wherein an absorbent material is deposited on said flat surface for use as a topical applicator.

Claim 7. A device, as set forth in Claim 1, wherein a mitt is fitted on an end of said second section remote from said first section for use as one of a diagnostic testing element and pharmaceutical applicator.

Claim 8. A device, as set forth in Claim 7, wherein said mitt is formed of an absorbent material.

Claim 9. A device, as set forth in Claim 7, wherein said mitt is formed of a brush-like material.

Claim 10. A device, as set forth in Claim 7, wherein said mitt is formed of an abrasive material.

Claim 11. A device, as set forth in Claim 1, wherein said second section comprises a first part forming an insert holder with a recess therein, and a removable insert extending in the length direction with one end fitted into said recess in said insert holder and another end spaced from said insert holder and forming one of a diagnostic testing element and a pharmaceutical applicator.

Claim 12. A device, as set forth in Claim 11, wherein said insert comprises an elongated base strip engageable in said insert holder and a testing strip located on said base strip and extending at least from an end of said base strip remote from the insert holder towards said insert holder.

Claim 13. A device, as set forth in Claim 2, wherein a wiper member is located within said cover and is arranged to be contiguous to said sealing means for wiping an end of said second section of said stem member when said stem member is used as a pharmaceutical applicator.