WO2025111656A1

WO2025111656A1 - Tissue sampling device

Info

Publication number: WO2025111656A1
Application number: PCT/AU2024/051278
Authority: WO
Inventors: Morris RITZ
Original assignee: Ritz Labs Pty Ltd
Current assignee: Ritz Labs Pty Ltd
Priority date: 2023-11-30
Filing date: 2024-11-29
Publication date: 2025-06-05
Anticipated expiration: 2026-05-30

Abstract

A tissue sampling device for collecting a tissue sample comprising: a body configured to be positioned in a hand of a user, the body having a first and an opposed second end; a blade member projecting from a first end of the body, the blade comprising a cutting blade having a substantially elliptical configuration defining a substantially elliptical space for cutting the tissue sample; and a set of forceps mounted at the opposed second end of the body for removing the tissue sample following cutting by the blade member; a plunger located within the body and controllable to extend into and out of the substantially elliptical space defined by the cutting blade to eject the tissue sample therefrom in the event that the tissue sample becomes lodged in the substantially elliptical space.

Description

TISSUE SAMPLING DEVICE

RELATED APPLICATION(S)

The present application claims priority from Australian Provisional Patent Application No. 2023903876, filed 30 November 2023, the entire contents of which are incorporated herein by reference.

FIELD OF INVENTION

The present invention relates generally to a handheld device for obtaining a tissue sample from a test subject, and in particular, to a biopsy punch for obtaining a skin tissue sample from a patient in an efficient and expedient manner.

BACKGROUND OF THE INVENTION

In medical applications, particularly in both dermatology and plastic surgery, there is often a need to obtain a sample of an individual’s skin tissue for further analysis. This may be necessary for annual testing of individuals with abnormal skin growths or those who may have a history of cancers, including melanoma, basal cell, squamous cell, and other types of skin cancers.

Typically, in order to take a sample of tissue or take out a small mole or lesion, a biopsy punch is used, which traditionally comprises a round circular cutting blade that fits over the region of tissue and is pushed into the skin to punch out the lesion. The blade may be rotated to penetrate into the skin where the patch of skin is then removed as required. Such a flat, circular blade is difficult to efficiently penetrate the skin of the patient as it can create more trauma at the site.

Another problem with such a device is that the wound created upon removal of the patch of skin is difficult to close without causing a scar. As the wound is circular, the edges of the wound may curl up when sutured, leaving a partially open wound that may take longer to heal and leave a scar with an uneven skin edge.

Thus, there is a need to provide an improved device for taking a skin tissue sample that minimises trauma at the site and which forms a wound that is easier to close with a suture or stitch and less likely to leave a scar after healing.

The above references to and descriptions of prior proposals or products are not intended to be, and are not to be construed as, statements or admissions of common general knowledge in the art. In particular, the above prior art discussion does not relate to what is commonly or well known by the person skilled in the art, but assists in the understanding of the inventive step of the present invention of which the identification of pertinent prior art proposals is but one part.

STATEMENT OF INVENTION

The invention according to one or more aspects is as defined in the independent claims. Some optional and/or preferred features of the invention are defined in the dependent claims.

Accordingly, in one aspect of the invention there is provided a tissue sampling device for collecting a tissue sample comprising: a body configured to be positioned in a hand of a user, the body having a first and an opposed second end; a blade member projecting from a first end of the body, the blade comprising a cutting blade having a substantially elliptical configuration defining a substantially elliptical space for cutting the tissue sample; and a set of forceps mounted at the opposed second end of the body for removing the tissue sample following cutting by the blade member; a plunger located within the body and controllable to extend into and out of the substantially elliptical space defined by the cutting blade to eject the tissue sample therefrom in the event that the tissue sample becomes lodged in the substantially elliptical space.

In one embodiment of the present invention, the set of forceps may be formed on the opposed second end of the body. A cap member may be configured to fit over the set of forceps formed on the second end of the body when the set of forceps are not in use.

In another embodiment of the present invention, the set of forceps may be mounted on the opposed second end of the body so as to be removable therefrom for use. The set of forceps may be mounted within a shaped recess formed on the opposed second end of the body.

The blade member may have a V-shaped end profile. The blade member may comprise an upper blade portion and a lower blade portion and each of the upper blade portion and the lower blade portion may have a V-shaped side profile that comes to a point at a central region thereof.

The ends of the upper blade portion and the lower blade portion may be honed or sharpened to facilitate smooth cutting of the tissue.

The plunger may have a substantially elliptical shape that conforms to the substantially elliptical space of the blade member.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be better understood from the following non-limiting description of preferred embodiments, in which:

Fig. 1 is a perspective view of a tissue sampling device in accordance with an embodiment of the present invention;

Fig. 2 is a perspective view of the device of Fig. 1 with the cap removed;

Fig. 3 is a front end perspective view of the device of Fig. 1;

Fig. 4 is a front end view of the blade member of the device of Fig. 1;

Fig. 5 is a perspective view of the blade member of Fig. 4;

Fig. 6 is a side view of the blade member of Fig. 4;

Fig. 7 - Fig. 10 are side views depicting how the device of Fig. 1 is used to collect a tissue sample for testing;

Fig. 11 is a perspective view of a tissue sampling device in accordance with another embodiment of the present invention; and

Fig. 12 is a perspective view of the device of Fig. 11 with the forceps/tweezers removed.

DETAILED DESCRIPTION OF THE DRAWINGS

Preferred features of the present invention will now be described with particular reference to the accompanying drawings. However, it is to be understood that the features illustrated in and described with reference to the drawings are not to be construed as limiting on the scope of the invention. The device of the present invention will be described below in relation to a disposable handheld biopsy punch. However, it will be appreciated that the device of the present invention may take a variety of forms and configurations and may be re-usable and capable of taking skin samples from human as well as animal subjects and still fall within the scope of the present invention.

Referring to Fig. 1 and Fig. 2, the device 10 of the present invention is depicted. The device 10 generally comprises a body 12 having a first end 11 and a second end 13 opposed to the first end 11. The body 12 is configured to be positioned in a hand of a user and has an elongate shape contoured to fit in the user’s hand like a pen or similar device.

The first end 11 has a blade member 14 extending therefrom. The blade member 14 will be described in more detail below but is configured to penetrate a surface of the skin of a subject to form a skin sample for removal as required. The blade member projects from the first end 11 so as to be positioned above the region of skin to be removed, such that as the blade member 14 is forced into the subject’s skin, it creates a sample for removal.

The second end 13 of the body 12 has forceps or tweezers 16 formed therein which are covered by a cap member 18 when not in use. The forceps or tweezers 16 can be used by the user of the device 10 to remove the sample created by the blade member 14 following cutting. In this regard, the user can simply rotate the device 10 in their hand to access the tweezers or forceps 16 which can then be manipulated to grip and remove the sample, as will be described in more detail below.

As is shown more clearly in Fig. 3, a plunger 20 is located centrally within the body 12 of the device 10 to move axially within the body 12. An end of the plunger 20 is located within the central opening 14a of the blade member 14 and axial movement of the plunger 20 is performed by movement of the slide member 15 along a slot 17 formed in the surface of the body 12, in the direction of the arrows. In this regard, should the skin sample formed by the blade member 14 become captured in the blade member 14 following the cutting step, the user of the device 10 can employ the plunger 20 to move within the central opening 14a of the blade member 14 to expel the tissue sample from the blade member 14, for collection. The user can simply position their finger on the slide member 15 to control the plunger 20 to perform such a function.

As is shown in Fig. 4, the end view of the blade member 14 is depicted. The blade member 14 comprises an upper blade 14b and a lower blade 14c that are arranged to form an overall elliptical or ovate shape with the central opening 14a formed therebetween. Each of the upper blade 14b and lower blade 14a have a substantially complementary curved shape and are formed from a metal such as stainless steel. This ensures that the wound formed from taking the sample will have a substantially elliptical shape to enable the wound to be stitched closed to form a more flattened scar that will heal in a more uniform manner. In this regard, as is depicted in Fig. 3, the plunger 20 may also have an elliptical or ovate shape that is complimentary to the opening 14a of the blade member 14.

As is shown in Fig. 5 and Fig. 6, the blade member 14 also has a V-shaped side profile, rather than a conventional flat blade. In this regard, each of the upper blade 14b and lower blade 14c have a V-shaped side profile that comes to a point at a central region thereof. Such a shaped blade member 14 has been found to cut better into the tissue to minimize bruising and trauma at the wound site. The ends of the upper blade 14b and lower blade 14c may be honed or sharpened to further facilitate smooth cutting of the tissue.

A manner in which a tissue sample 5 may be taken from a subject’s tissue 6 will be described below in relation to Fig. 7 - Fig. 10.

As shown in Fig. 7, to start the procedure, the device 10 is brought into contact with the subject’s tissue 6 at the site upon which the sample is to be taken. The blade member 14 is positioned over the surface of the skin, which may include a mole or growth that the sample is to test.

As shown in Fig. 8, to obtain the sample the blade member 14 is inserted into the surface of the tissue such that the upper blade 14b and lower blade 14c penetrate the tissue 6 with the V-shaped blades performing the initial insertion. The device 10 is then pushed into the tissue 6 such that the end 11 of the body 12 of the device 10 becomes in contact wit the surface of the tissue 6, as shown. In this position, the sample to be taken is present in the opening 14a of the blade member 14, with the upper blade 14b and lower blade 14c forming an elliptical cut around the sample of tissue to be taken for testing.

The device 10 is withdrawn from the tissue surface 6 in the manner as depicted in Fig. 9. As the blade member 14 is withdrawn, it is possible that the sample 5 may become stuck within the opening 14a of the blade member 14. To prevent this, the plunger 20 may be employed by the user of the device 10 to apply a pressure against the sample 5 present in the opening 14a of the blade member 14. This will resist the sample 5 becoming captured within the blade member upon withdrawal such that the sample 5 is retained with the tissue 6. As is shown in Fig. 10, upon the complete withdrawal of the blade member 14 from the tissue 6, the device 10 is rotated 180° such that the user can access the forceps/tweezers 16. The user can then use the forceps/tweezers 16 to collect the sample for testing as required. This can be achieved without requiring a separate tool as the tweezers/forceps 16 are part of the device 10.

Upon formation and collection of the sample, the device 10 can be disposed by placing the device 10 into a receptacle for collection and disposal in a safe manner.

An alternative embodiment of the present invention is depicted in Fig. 11 and Fig. 12 as device 30. Device 30 functions in substantially the same manner as device 10 described above, and the same reference numerals have been used to refer to the same features as described above in relation to device 10.

Device 30 comprises a body 12 that is to be held in a hand of a user for taking a tissue sample. The first end 11 of the body 12 has a blade member 14 to be manipulated by the user of the device 30 to form the sample, A plunger (not shown) is provided in the body 12 to eject the sample from the blade member 14 in the manner as described above, and a slide member 15 is movable within a slot 17 to control movement of the plunger (not shown).

The main difference between device 30 and device 10, is that rather than the second end 13 of the device 30 being formed as forceps/tweezers, the second end 13 of device 30 is configured to contain a removable pair of forceps/tweezers 32 for separate use by the operator of the device 30. In this regard, as is more clearly shown in Fig. 12, the second end 13 of the device 30 has a shaped groove 34 formed there in that is complementary to the shape of the tweezers/forceps 32, such that the tweezers/forceps 32 can simply slide out of the groove 34 for use. In this arrangement, after using the device 30 to cut the sample, the user can simply collect the sample from the subject tissue by removing the tweezers/forceps 32 and collecting the sample for testing.

It will be appreciated that the device 10, 30 provides a simple tool that can be used by a user to take and collect a tissue sample for testing without the need to use multiple devices to perform the procedure.

Throughout the specification and claims the word “comprise” and its derivatives are intended to have an inclusive rather than exclusive meaning unless the contrary is expressly stated or the context requires otherwise. That is, the word “comprise” and its derivatives will be taken to indicate the inclusion of not only the listed components, steps or features that it directly references, but also other components, steps or features not specifically listed, unless the contrary is expressly stated or the context requires otherwise.

It will be appreciated by those skilled in the art that many modifications and variations may be made to the methods of the invention described herein without departing from the spirit and scope of the invention.

Claims

The claims defining the invention are as follows:

1. A tissue sampling device for collecting a tissue sample comprising: a body configured to be positioned in a hand of a user, the body having a first and an opposed second end; a blade member projecting from a first end of the body, the blade comprising a cutting blade having a substantially elliptical configuration defining a substantially elliptical space for cutting the tissue sample; and a set of forceps located at the opposed second end of the body for removing the tissue sample following cutting by the blade member; and a plunger located within the body and controllable to extend into and out of the substantially elliptical space defined by the cutting blade to eject the tissue sample therefrom in the event that the tissue sample becomes lodged in the substantially elliptical space.

2. A tissue sampling device according to claim 1, wherein the set of forceps is formed on the opposed second end of the body.

3. A tissue sampling device according to claim 2, wherein a cap member is configured to fit over the set of forceps formed on the second end of the body when the set of forceps are not in use.

4. A tissue sampling device according to claim 1, wherein the set of forceps is mounted on the opposed second end of the body so as to be removable therefrom for use.

5. A tissue sampling device according to claim 4, wherein the set of forceps is mounted within a shaped recess formed on the opposed second end of the body.

6. A tissue sampling device according to claim 1, wherein the blade member has a V-shaped end profile.

7. A tissue sampling device according to claim 6, wherein the blade member comprises an upper blade portion and a lower blade portion and each of the upper blade portion and the lower blade portion have a V-shaped side profile that comes to a point at a central region thereof.

8. A tissue sampling device according to claim 7, wherein the ends of the upper blade portion and the lower blade portion are honed or sharpened to facilitate smooth cutting of the tissue.

9. A tissue sampling device according to any one of the preceding claims, wherein the plunger has a substantially elliptical shape that conforms to the substantially elliptical space of the blade member.