WO2023230645A1

WO2023230645A1 - Implant casing

Info

Publication number: WO2023230645A1
Application number: PCT/AU2023/050423
Authority: WO
Inventors: Dilesh WADIA
Original assignee: Apsyrtus Biotechnology Pty Ltd
Priority date: 2022-05-31
Filing date: 2023-05-18
Publication date: 2023-12-07

Abstract

In one aspect, a casing (10) for implantation under a skin portion of a living body (of an animal, such as a pet) is disclosed. In one arrangement and embodiment, the casing (10) comprises a body having a front end (12) and a rear end (14), the front end (12) being adapted to be received by an incision made in the skin portion and the rear end (14) comprising a first cavity, wherein the body of the casing (10) comprises at least one flat surface for resting on a surface below the skin portion.

Description

IMPLANT CASING

TECHNICAL FIELD

[0001] The present invention relates to a casing for a medical implant.

BACKGROUND

[0002] Any discussion of the background art throughout the specification should in no way be considered as an admission that such background art is prior art, nor that such background art is widely known or forms part of the common general knowledge in the field in Australia or worldwide.

[0001] All references, including any patents or patent applications, cited in this specification are hereby incorporated by reference. No admission is made that any reference constitutes prior art. The discussion of the references states what their authors assert, and the Applicant reserves the right to challenge the accuracy and pertinence of the cited documents. It will be clearly understood that, although a number of prior art publications may be referred to herein, this reference does not constitute an admission that any of these documents forms part of the common general knowledge in the art, in Australia or in any other country.

[0003] It has been common practice to introduce electronic devices such as microchips below pet’s skin in order to, for example, be able to identify the name of the pet in case the pet gets lost, and more importantly to identify the details of pet’s owner with the objective of returning the pet to its rightful owner.

[0004] In particular applications, the electronic devices are incorporated in casings with the intention to implant the electronic devices (whilst being located within these casings) into living bodies such as animal or human bodies.

[0005] The conventional casings for containment of microchips are not of a size that would permit containment of non-conventional chips of a relatively large size, in particular due to the relatively small diameter of the conventional casing.

[0006] Moreover, conventional casings are cylindrical. There are several drawbacks of using cylindrical casings. Cylindrical casings should have a relatively small diameter to avoid that the casings create an easily noticeable lump in the living bodies’ skin when the casings are implanted in the living bodies. This has as a consequence that non- conventional microchips cannot be implanted in the living body using the conventional casings. An obvious option would be to increase the diameter of the convention casing to be able to fit a non-conventional microchip. However, this not an option because, when implanting the conventional casing (of increased diameter) under the skin of the living body, a lump would form that can be easily noticed and may present a health risk to the living body.

[0007] A further drawback is that the curved surfaces of the cylindrical casings typically cause reflection of light impacting onboard optical sensors on the implant. This is particularly if the microchips within the casings are adapted to use such optical sensors to, for example, measure heart rate and saturation of peripheral oxygen of the living bodies that incorporate the casings.

[0008] Another drawback is that cylindrical casings, due to their circular crosssection may easily rotate about their longitudinal axis. Thus, the orientation of the microchip, contained in a rotated casing, will vary resulting in that the microchip typically becomes inoperative. This will require reorientation of the casing, which only can be done with invasive procedures comprising: (1) piercing the skin of the living body; and (2) removing and repositioning the casing from under the skin of the living body in order to return the casing to its original orientation so that the microchip may become once again operative.

[0009] It is against this background that the present invention has been developed.

SUMMARY OF INVENTION

[0010] It is an object of the present invention to overcome or ameliorate at least one or more of the disadvantages of the prior art, to provide a useful alternative, and/or to provide consumers with a commercial choice.

[0011 ] According to a first aspect of the invention, there is provided a casing for implantation under a skin portion of a living body, the casing comprising a body having a front end and a rear end, the front end being adapted to be received by an incision made in the skin portion and the rear end comprising a first cavity, wherein the body of the casing comprises at least one flat surface for resting on a surface below the skin portion.

[0012] Preferably, the front end comprises a second cavity in communication with the first cavity of the rear end defining a main cavity located within the casing.

[0013] Preferably, the rear end comprises the at least one flat surface.

[0014] Preferably, the rear end comprises a flat bottom defining the flat surface.

[0015] Preferably, the rear end comprises an open end in communication with the first cavity, adapted to receive a device for containment within the casing, and preferably within the main cavity.

[0016] Preferably, the open end is adapted to receive a material, preferably a resin, for embedding the device within casing, and preferably within the main cavity.

[0017] Preferably, the resin seals the open end once the resin has been cured.

[0018] Preferably, the resin is biomedical grade resin.

[0019] Preferably, the device comprises an electronic device.

[0020] Preferably, the body of the casing comprises a flat top.

[0021] In an arrangement, the body of the casing is configured as a parallelepiped.

[0022] Preferably, the parallelepiped is of rectangular configuration.

[0023] Preferably, the body of the casing comprises round corners.

[0024] Preferably, the front end is of tapered configuration defining a tapered end adapted to be received by the incision made in the skin portion.

[0025] Preferably, the front end comprises tapered sides and a tapered top and a horizontal front bottom and a straight front wall joining together the end edges of the sides and the top and the bottom.

[0026] Preferably, the bottom of the front end comprises a horizontal surface. [0027] Preferably, the flat surface of the casing is defined by the flat bottoms of the front end and rear end.

[0028] Preferably, the body of the casing comprises biomedical grade glass.

[0029] According to a second aspect of the invention, there is provided a casing in accordance with the first aspect of the invention comprising a device, preferably an electronic device contained within the casing, and preferably within the main cavity of the casing.

[0030] According to a third aspect of the invention, there is provided a mould for manufacturing a casing in accordance with the first aspect of the invention, the mould comprising a body having inner surfaces configured for defining the casing in accordance with the first aspect of the invention, and spacing means for keeping centred a device, preferably an electronic device, within the casing.

[0031] According to a fourth aspect of the invention, there is provided a method for implantation of an electronic device under a skin portion of a living body, the method comprising the steps of: provision of a casing comprising the electronic device, the casing having at least one flat surface; and implanting the casing under the skin portion of a living body such that the flat surface abuts a portion of the living body located under the skin portion of the living body.

[0032] According to a fifth aspect of the invention, there is provided a method for manufacturing a casing in accordance with the first aspect of the invention, the method comprising the steps of: provision of a mould comprising a body having inner surfaces configured for defining the casing in accordance with the first aspect of the invention; defining spacing means within the mould for keeping centred an electronic device within the casing; and inserting the electronic device within the mould such that the electronic device is centred within the casing via the spacing means.

[0033] Other objects and advantages of the present invention will become apparent from the following description, taken in connection with the accompanying drawings, wherein, by way of illustration and example, at least one preferred embodiment of the present invention is disclosed.

BRIEF DESCRIPTION OF DRAWINGS

[0034] Notwithstanding any other forms which may fall within the scope of the present invention, in order that the invention may be more fully understood and put into practice, preferred embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0035] Figure 1 is a side view of a particular arrangement of a casing in accordance with a particular embodiment of the invention;

[0036] Figure 2 is a top view of the casing shown in figure 1 ;

[0037] Figure 3 is a front view of the casing shown in figure 1 ; and

[0038] Figure 4 is a rear view of the front end of the casing shown in figure 1.

DEFINITIONS

[0039] The following definitions are provided as general definitions and should in no way limit the scope of the present invention to those terms alone, but are put forth for a better understanding of the following description.

[0040] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the invention belongs. It will be further understood that terms used herein should be interpreted as having a meaning that is consistent with their meaning in the context of this specification and the relevant art and will not be interpreted in an idealised or overly formal sense unless expressly so defined herein. For the purposes of the present invention, additional terms are defined below. Furthermore, all definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms unless there is doubt as to the meaning of a particular term, in which case the common dictionary definition and/or common usage of the term will prevail. [0041] For the purposes of the present invention, the following terms are defined below.

[0042] The articles “a” and “an” are used herein to refer to one or to more than one

(i.e. to at least one) of the grammatical object of the article. By way of example, "an element" refers to one element or more than one element.

[0043] The term “about” is used herein to refer to quantities that vary by as much as 30%, preferably by as much as 20%, and more preferably by as much as 10% to a reference quantity. The use of the word ‘about’ to qualify a number is merely an express indication that the number is not to be construed as a precise value.

[0044] Throughout this specification, unless the context requires otherwise, the words “comprise”, “comprises” and “comprising” will be understood to imply the inclusion of a stated step or element or group of steps or elements but not the exclusion of any other step or element or group of steps or elements.

[0045] Any one of the terms: “including” or “which includes” or “that includes” as used herein is also an open term that also means including at least the elements/features that follow the term, but not excluding others. Thus, “including” is synonymous with and means “comprising”.

[0046] In the claims, as well as in the summary above and the description below, all transitional phrases such as “comprising”, “including”, “carrying”, “having”, “containing”, “involving”, “holding”, “composed of, and the like are to be understood to be open- ended, i.e. to mean “including but not limited to”. Only the transitional phrases “consisting of and “consisting essentially of alone shall be closed or semi-closed transitional phrases, respectively.

[0047] Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, preferred methods and materials are described. It will be appreciated that the methods, apparatus and systems described herein may be implemented in a variety of ways and for a variety of purposes. The description here is by way of example only.

[0048] As used herein, the term “exemplary” is used in the sense of providing examples, as opposed to indicating quality. That is, an “exemplary embodiment” is an embodiment provided as an example, as opposed to necessarily being an embodiment of exemplary quality for example serving as a desirable model or representing the best of its kind.

[0049] Also, various inventive concepts may be embodied as one or more methods, of which an example has been provided. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.

[0050] The phrase “and/or”, as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e. elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and/or” should be construed in the same fashion, i.e. “one or more" of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and/or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to “A and/or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.

[0051] As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and/or” as defined above. For example, when separating items in a list, “or” or “and/or" shall be interpreted as being inclusive, i.e. the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of” or “exactly one of’, or, when used in the claims, “consisting of” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e. “one or the other but not both”) when preceded by terms of exclusivity, such as “either”, “one of, “only one of, or “exactly one of. “Consisting essentially of, when used in the claims, shall have its ordinary meaning as used in the field of patent law.

[0052] As used herein in the specification and in the claims, the phrase “at least one”, in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, “at least one of A and B” (or, equivalently, “at least one of A or B”, or, equivalently “at least one of A and/or B”) can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.

[0053] For the purpose of this specification, where method steps are described in sequence, the sequence does not necessarily mean that the steps are to be carried out in chronological order in that sequence, unless there is no other logical manner of interpreting the sequence.

DESCRIPTION OF EMBODIMENTS

[0054] Figures 1 and 2 show a particular arrangement of a casing 10 (which may also be referred to as a shell) in accordance with the present embodiment of the invention. The casing 10 is adapted to be implanted within, for example, a living body of an animal for monitoring, for example particular vital signs of the animal (as a patient).

[0055] The casing 10 comprises a body having a front end 12 and a rear end 14. The front end 12 is configurated in such a manner to facilitate implantation of the casing 10 into an animal's body, in particular, under the skin of the animal. The rear end 14 is adapted to receive a device, and particularly an electronic device in the embodiment. [0056] As shown in figures 3 and 4, the front end 12 comprises tapered sides 16, a tapered top 18, a horizontal front bottom 20, and a straight front wall 22 joining together the sides 16 and top 18 and bottom 20.

[0057] The front bottom 20 is flat (i.e. non-tapered). In this manner, the front end 12 is configured as a tapered nose-like end facilitating insertion of the casing 10 into the animal’s body. In particular, the tapered configuration of the front end 12 allows for a smaller incision to be made in the animal’s skin for implanting the casing 10 under the animal’s skin. This is particularly true due to the elasticity properties of animal skin such as in dogs and cats.

[0058] The front end comprises a cavity 34 (the second cavity) which together with a cavity within the rear end 14 define a main cavity within the casing 10.

[0059] Further, referring now to figures 1 and 2, the rear end 14 comprises a rear top 28, a rear bottom 30, and side walls 32a and 32b.

[0060] The rear end 14 of the body of the casing 10 is configured as a parallelepiped having an end 24 and an open end 26. The open end 26 is adapted (as will be described below in relation to the method of operation of the casing 10) to receive the electronic device (such as a microchip) to be contained in the casing 10 and subsequently introduced within the animal’s body when implanting the casing 10 into the animal’s body.

[0061 ] Furthermore, as shown in figure 1 , the body of the casing 10 comprises a bottom 21 having at least one flat surface defined by the front bottom 20 and the rear bottom 30. The fact the bottom 21 of the casing 10 is configured as a flat surface is particularly useful because it ensures (or at least mitigates) that the casing 10 is not pushed upwards during the implantation process, reduces tension on the animal's skin, and also causes the casing 10 to rest at a reduced height with respect to the surface below animal’s skin. By being at a reduced height, the casing 10 appears to be of reduced size whilst being under the animal’s skin; thus, a noticeable lump will not be formed protruding skin of the body.

[0062] The rear end comprises a cavity (the first cavity) accessible through the open end 26 of the rear end 14. This first cavity together with the second cavity of the front end 12 define the main cavity of the casing 10 for receiving, for example, an electronic device as will be discussed below.

[0063] A particular application of the casing 10 is for containment of electronic devices such as microchips adapted to detect particular vital signs of the animal and generating electric signals representative of these particular vital signs of the animal. Examples of particular vital signs can be heart rate (HR) and saturation of peripheral oxygen ( SpO₂). The electronic devices may also be adapted to store information related to the animal (such as name, name and address of the rightful owner, vaccination status, amongst others) and/or comprising means for finding the animal in case the animal gets lost.

[0064] The casing 10 is adapted to receive the electronic device for containment within the casing 10 allowing locating the electronic device under the skin of the animal. This allows, for example, for monitoring of the animal’s health by continuous measurement of the animal’s particular vital signs such as HR as well as measuring the SpO₂ levels.

[0065] In operation, the electronic device is placed into the casing 10 via the open end 26 of the rear end 14. Subsequently, a material, preferably a resin and in particular biomedical grade resin in the embodiment, is poured into the casing 10, through the open end 26, in such a quantity to fully embed the electronic device within the resin and ensuring that the open end 26 is completely closed due to the presence of the resin within the casing 10. Upon completion of the curing process of the resin within the casing 10, the casing 10, containing the electronic device, may be implanted within the animal's body. Implantation of the casing 10 may be done with implantation tools specifically designed for delivering the casing 10 below the animal’s skin.

[0066] It will be appreciated that the embedding and sealing material is not limited to resin or biomedical grade resin, and in alternative embodiments of the invention other, additional, or alternative, suitable material(s) may be used for this purpose.

[0067] In a particular arrangement, the casing 10 is made from biomedical grade glass tube stock. In accordance with the arrangement shown in the figures, the glass tube has a rectangular cross-section perpendicular to the longitudinal axis of the glass tube. The glass tube may have curved edges. It is particularly useful that the glass tube has round edges because this causes the casings 10, made out of the glass tube, to be less noticeable when implanted below animal’s skin.

[0068] The glass tube stock is reformed to have the desired overall dimension, and, it is cut to produce a plurality of glass tube sections to manufacture a plurality of casings 10 of the desired length. Each glass section is then reformed to define the tapered front end 12. Subsequently, each glass tube section is fire polished.

[0069] The casing 10 comprises a single piece (of formed glass), in the embodiment.

[0070] It will be appreciated that the casing is not limited to being made from biomedical grade glass tube stock, and in alternative embodiments of the invention the casing may be made from other, additional, or alternative, suitable material(s).

[0071] It will be appreciated that the described embodiment of the invention provides several advantages as highlighted and described earlier herein.

[0072] In fact, the casing 10 according to the present embodiment of the invention is particularly advantageous because, for example, the tapered front end permits cutting a smaller incision in the animal’s skin and a smaller tunnelled cavity below the skin for containment of the casing 10. This allows for a quicker healing after completion of the implantation process. Also, the fact that the bottom of the casing 10 is flat ensures that the casing 10 is kept in the originally implanted condition, or at least mitigates the casing 10 moving from the originally implanted condition.

[0073] It will be appreciated by those skilled in the art that variations and modifications to the invention described herein will be apparent without departing from the spirit and scope thereof. The variations and modifications as would be apparent to persons skilled in the art are deemed to fall within the broad scope and ambit of the invention as herein set forth.

[0074] For example, in alternative arrangements of the present embodiment of the invention the casing 10 may be configured as having different shapes and dimensions (compared to the casing 10 depicted in figures 1 and 2) to permit containment of electronic devices of larger size due to, for example, requiring relatively larger batteries and different orientation of parts.

[0075] The casing 10 has been described with reference to as being implanted in an animal body. However, the casing 10 may be implanted in any living body such as a human body.

[0076] Moreover, in accordance with an alternative embodiment of the invention, instead of defining the casing 10 using a glass shell, a mould may be configured for casting, using biomedical grade resin (or other suitable material), the casing 10. The mould comprises a body having inner surfaces configured for defining the external appearance of the casing 10 such as, for example, the one depicted in figures 1 to 4. The mould comprises spacing means for keeping centred the electronic device within the mould for casting of the casing 10 incorporating the electronic device with the casing 10. In an arrangement, the electronic device may be potted in the mould comprising the resin for manufacturing a casted casing 10 having embedded therein the electronic device.

[0077] The present application claims priority from Australian Provisional Patent Application No. 2022901477, the contents of which are incorporated herein by reference in their entirety.

Claims

CLAIMS The claims defining the invention are as follows:

1. A casing for implantation under a skin portion of a living body, the casing comprising a body having a front end and a rear end, the front end being adapted to be received by an incision made in the skin portion and the rear end comprising a first cavity, wherein the body of the casing comprises at least one flat surface for resting on a surface below the skin portion.

2. A casing according to claim 1 , wherein the front end comprises a second cavity in communication with the first cavity of the rear end defining a main cavity located within the casing.

3. A casing according to claim 1 or 2, wherein the rear end comprises the at least one flat surface.

4. A casing according to claim 3, wherein the rear end comprises a flat bottom defining the flat surface.

5. A casing according to any one of the preceding claims, wherein the rear end comprises an open end in communication with the first cavity, adapted to receive a device for containment within the casing.

6. A casing according to claim 5, wherein the open end is adapted to receive a material for embedding the device within the casing.

7. A casing according to claim 6, wherein the material comprises a resin.

8. A casing according to claim 7, wherein the resin seals the open end once the resin has been cured.

9. A casing according to claim 7 or 8, wherein the resin is biomedical grade resin.

10. A casing according to any one of claims 5 to 9, wherein the device comprises an electronic device.

11. A casing according to any one of the preceding claims, wherein the body of the casing comprises a flat top.

12. A casing according to any one of the preceding claims, wherein the body of the casing is configured as a parallelepiped.

13. A casing according to claim 12, wherein the parallelepiped is of rectangular configuration.

14. A casing according to any one of the preceding claims, wherein the body of the casing comprises round comers.

15. A casing according to any one of the preceding claims, wherein the front end is of tapered configuration defining a tapered end adapted to be received by the incision made in the skin portion.

16. A casing according to claim 15, wherein the front end comprises tapered sides and a tapered top and a horizontal front bottom and a straight front wall joining together the end edges of the sides and the top and the bottom.

17. A casing according to claim 16, wherein the bottom of the front end comprises a horizontal surface.

18. A casing according to claim 16, when dependent on claim 4, wherein the flat bottom of the casing is defined by the flat bottoms of the front end and rear end.

19. A casing according to any one of the preceding claims, wherein the body of the casing comprises biomedical grade glass.

20. A casing according to any one of the preceding claims, comprising a device contained within the casing.

21 . A mould for manufacturing a casing in accordance with any one of the preceding claims, the mould comprising a body having inner surfaces configured for defining the casing in accordance with any one of the preceding claims, and spacing means for keeping centred a device within the casing.

22. A method for implantation of an electronic device under a skin portion of a living body, the method comprising the steps of: provision of a casing comprising the electronic device, the casing having at least one flat surface; and implanting the casing under the skin portion of a living body such that the flat surface abuts a portion of the living body located under the skin portion of the living body.

23. A method for manufacturing a casing in accordance with any one of claims 1 to 20, the method comprising the steps of: provision of a mould comprising a body having inner surfaces configured for defining the casing in accordance with any one of claims 1 to 20; defining spacing means within the mould for keeping centred an electronic device within the casing; and inserting the electronic device within the mould such that the electronic device is centred within the casing via the spacing means.