TECHNICAL FIELD

[0001] The present invention relates to a surgical tool for insertion of a medical implant.

[0002] In one aspect the present invention relates to a surgical tool comprising expandable blades used for insertion of a medical implant. In another aspect the present invention relates to a self-cutting surgical device with the blades comprising cutting edges.

BACKGROUND

[0003] 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.

[0004] 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.

[0005] 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.

[0006] The conventional microchips are implanted beneath the animal’s skin using a bore open needle with a plunger at the back. However, this process is not applicable for non-conventional chips of a relatively large size, in particular due to the relatively small bore diameter of the open needle. [0007] The needle/bore size is an “open” design permitting conventional microchips to pass though the needle for implantation of the microchips into the pets’ body. These types of devices are not applicable for relatively large non-conventional micro-chips because the needle point would introduce foreign material, such as hair and debris in though the surgical site, which is unwanted due to health reasons.

[0008] Other current devices make use of a stylet-type device adapted to pass through a bore of a cannula. However, this requires a minimum of two steps for implanting the micro-chip into the pet’s body. This increases human labour during implantation of the microchip.

[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 surgical tool for implanting an implant in a living body, the surgical tool comprising a body having a compartment for containment of the implant, transference means operatively connected to the compartment for moving of the implant for delivery of the implant into an incision of the living body, and delivery means operatively connected to the compartment and adapted to engage the incision for delivery of the implant into the living body through the incision.

[0012] Preferably, the implant comprises a device, and more preferably an electronic device.

[0013] Preferably, the living body comprises a body of an animal for use as a pet, working animal, or performance animal, as well as for use in research, sports and zoos, and the animal and human food industry.

[0014] Preferably, engagement between the delivery means and the incision comprises keeping the incision open whilst the implant is inserted in the living body. [0015] Preferably, the surgical tool comprises a cannula defining the compartment.

[0016] Preferably, the cannula comprises a proximal end adapted to receive the implant, and a distal end for receiving the delivery means.

[0017] Preferably, the delivery means comprises an insertion tip.

[0018] Preferably, the insertion tip is adapted to cut the incision in the living body.

[0019] In an alternative arrangement, the insertion tip is void of cutting edges adapted to cut the incision in the living body.

[0020] Preferably, the transference means comprise a plunger.

[0021] Preferably, the plunger is adapted to be received within the compartment, and more preferably the cannula when provided, and to selectively slide at least between a retracted condition and an extended condition for pushing or ejecting the implant from the surgical tool.

[0022] Preferably, the insertion tip comprises a plurality of blades adapted to selectively be displaced for locating the insertion tip in a closed condition and an open condition.

[0023] Preferably, the blades are located opposite to each other and their apexes being adapted to be joined together for defining the insertion tip.

[0024] Preferably, the blades are of triangular configuration having bases adapted to be attached to a distal end of the compartment, and more preferably the cannula when provided, and apexes adapted to be joined together to define the insertion tip.

[0025] The apexes may be joined touchingly together to define the insertion tip.

[0026] Preferably, the blades are cutting blades comprising cutting edges to define at least a relatively, and more preferably surgically, sharp pointed apex facilitating cutting of the incision into the living body.

[0027] In an alternative arrangement, the blades comprise blunt edges to define a non-cutting insertion tip. [0028] Preferably, the base of each blade is attached to the distal end of the compartment, and more preferably the cannula if provided, via a pivoting joint permitting each blade to be selectively moved in such a manner for locating, selectively, the insertion tip in a closed condition and an open condition.

[0029] Preferably, the pivot joint may be a self-retracting pivot joint.

[0030] In an alternative arrangement, the blades may be manufactured out of a resilient material and the attachment between the blade and the distal end of the compartment, and more preferably the cannula when provided, is void of a pivot joint.

[0031] Preferably, the surgical tool comprises means for indicating (to a user, such as a surgeon, for example), prior to insertion of the implant into the living body, the particular orientation that the implant has when located within the surgical tool.

[0032] Preferably, the cross-section along the transverse plane of the compartment, and more preferably the cannula when provided, is of polygonal configuration.

[0033] According to a second aspect of the invention, there is provided a method for implanting an implant in a living body through an incision made in the living body, the method comprising the steps of: engaging the incision with delivery means of a surgical tool comprising the implant to keep the incision open; and delivering the implant into the living body through the incision.

[0034] Preferably, the method comprises cutting the incision using the delivery means.

[0035] In alternative arrangement, the method comprises cutting the incision prior to engaging the incision with delivery means.

[0036] Preferably, the method comprises the step of moving the implant out of the surgical tool using transference means.

[0037] 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

[0038] 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 practise, preferred embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0039] Figure 1 is a cross-sectional side view of a particular arrangement of a surgical tool in accordance with an embodiment of the invention including an implant prior to exiting the insertion tip of the surgical tool;

[0040] Figure 2 is a cross-sectional side view of the insertion tip in closed condition prior the implant exiting the insertion tip;

[0041] Figure 3 is a cross-sectional side view of the insertion tip in semi-closed condition during the implant opening the insertion tip;

[0042] Figure 4 is a cross-sectional side view of the insertion tip in open condition during the implant exiting the insertion tip;

[0043] Figure 5 is a front view of the surgical tool;

[0044] Figure 6 is a cross-sectional plan view of the surgical tool shown in figure 1 comprising marking indicating orientation of the surgical tool; and

[0045] Figure 7 is a schematic perspective view of the surgical tool shown in figure 1 with the insertion tip removed.

DEFINITIONS

[0046] 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.

[0047] 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.

[0048] For the purposes of the present invention, the following terms are defined below.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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”.

[0053] 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.

[0054] 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.

[0055] 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.

[0056] 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.

[0057] 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.

[0058] 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.

[0059] 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.

[0060] 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

[0061 ] Embodiments of the invention relate to a surgical device or tool 10 for delivering implants 12 into a living body such as a body of an animal, that is a patient of a veterinary surgeon. The animal may be, for example: a pet; a working animal; a performance animal; or an animal for use in research, sports, and zoos, or the animal or human food industry.

[0062] The surgical tool 10 is adapted to contain an implant 12 to be inserted into the animal’s body, and to deliver the implant 12 into the animal’s body through an incision made in the animal’s skin.

[0063] In accordance with a first embodiment of the invention shown in figures 1 to 6, the surgical tool 10 is adapted to make the incision in the animal’s body. In accordance with alternative embodiments of the invention, the surgical tool 10 is void of cutting means for making an incision in the animal’s skin. Instead, the surgical tool 10 may comprise delivery assembly 14 which are adapted to selectively be opened and closed for delivery of the implant 12 into the animal’s body through an incision made in the animal’s skin. In these particular embodiments, the surgeon may use a scalpel blade independent from the surgical tool 10 for making the incision prior to delivery of implant 12.

[0064] The implant 12 may be a device, and preferably an electronic device containing 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. The electronic device may comprise a chip, and may be a subcutaneous biosensor device.

[0065] In accordance with the first embodiment, the surgical tool 10 comprises a body having a delivery assembly 14 and a compartment 16 for containment of the implant 12. Transference means 18 are included in the surgical tool 10 for moving the implant 12 from the compartment 16 into the animal’s body after a cutting tool part of the delivery assembly 14 has made an incision in the animal’s skin permitting locating the implant within the animal’s body.

[0066] The delivery means 14 are adapted to deliver the implant 12 through the incision into the animal’s body whilst engaging the incision to facilitate delivery of the implant into the animal’s body. Engagement between the delivery means 14 and the incision includes, for example, keeping the incision open to facilitate entrance of the implant 12 into the animal’s body through the incisions made in the animal’s skin.

[0067] In accordance with the first embodiment, the delivery means 14 comprises a cutting tool adapted to cut the incision in the living body. The second embodiment of the invention would be substantially the surgical tool 10 in accordance with the first embodiment of the invention but without the cutting tool of the delivery means 14.

[0068] Figures 1 and 2 show a particular arrangement of the surgical tool 10 in accordance with the first embodiment of the invention.

[0069] As shown in figure 1 , the surgical tool 10 comprises a cannula 20 defining the compartment 16 for containment of the implant 12. The cannula 20 comprises a proximal end 22 adapted to receive the implant 12, and a distal end 24 for receiving an insertion tip 26. The insertion tip 26 comprises the delivery means 14.

[0070] Further, the surgical tool 10 comprises a plunger 28 acting as the transference means 18 for moving the implant 12 out of the cannula 20 with the objective of implanting the implant 12 into the animal’s body. The plunger 28 is adapted to be received within the cannula 20 and to selectively slide, whilst being - at least partially - inserted in the cannula 20, at least between a retracted condition or position as shown in figure 1 and an extended condition or position as shown in figure 4. The sliding movement of the plunger 28 allows pushing or ejecting the implant 12 to deliver the implant 12 into the animal’s body. Figures 2 to 4 shows the process of moving the implant 12 out of the cannula 20.

[0071] The plunger 28 comprises a distal end 30 adapted to contact the implant 12 during delivery of the implant 12 into the animal’s body, and a proximal end 32 adapted to receive a pushing force generated by, for example, the surgeon during the implantation process of the implant 12. The proximal end 32 comprises a plunger flange 34 facilitating pushing of the plunger 28 as well as permitting pulling of the plunger out of the cannula 20 for inserting the implant 12 into the cannula 20.

[0072] As mentioned before, the proximal end 22 of the cannula 20 is adapted to receive the distal end 30 of the plunger 30. As shown in figure 1 , an opening is provided at the proximal end 22 of the cannula having a seal assembly 34. The seal assembly 34 seals the interior of the cannula 20 from the exterior of the cannula 20 as well as ensures that the plunger 28 is kept coaxially with respect to the longitudinal axis of the cannula 20 when the plunger is undergoing sliding movement. The seal assembly 34 acts as a valve allowing intake and exit of air during movement of the plunger 28.

[0073] Referring now to figures 2 to 5, figures 2 to 4 depict the process of moving the implant 12 out of the cannula 20 (not shown for illustration purposes) for insertion into the animal’s body. Figure 5 shows a front view of the insertion tip 26.

[0074] As shown in figure 2, at the initial stages of the process of ejecting the implant 12 from the surgical device 10, the implant 12, due the plunger 28 applying a pushing force, is moved towards the distal end 24 of the cannula 20 comprising the insertion tip 26.

[0075] The insertion tip 26 is adapted to permit exit of the implant 12 from the cannula 20. For this, the insertion tip 26 comprises a plurality of blades 38 opposite to each other in such a manner for defining the insertion tip 26.

[0076] The blades 38 are adapted to be selectively displaced or separated for locating the insertion tip 26 in a closed condition and an open condition. As will be described with reference to the method of operation of the surgical tool 10, in the closed condition, the insertion tip 26 is adapted to make the incision in the animal’s body by puncturing the skin of the animal, and in the open condition (where the blades 38 are separated) the insertion tip 26 is adapted to allow exit of the implant 12 as shown in figure 4. Exit of the implant 12 is facilitated by the blades 38 separating when pressure of the pushing force is applied against them by the implant 12 acted on by the plunger 28, as shown in figure 4. By application of the pushing force, the implant 12 is pushed out through an opening formed by the blades 38 separating, to ultimately embed within desired tissue under the skin of the animal.

[0077] Figure 5 shows a particular arrangement of the insertion tip 26 in accordance with the present embodiment of the invention in the closed condition. As shown in figure 5, the blades 38a and 38b are of triangular configuration with their bases 40 adapted to be attached to the distal end 24 of the cannula 20 and their apexes 42 adapted to be joined (touchingly in the embodiment) together to define the insertion tip 26, in particular, the cutting tool 14. The blades 38a and 38b are opposite to each other such that their apexes 42 abut each other defining a pointed apex 44 adapted to puncture the animal’s skin. The blades 38 are cutting blades comprising cutting side edges (meeting in the closed condition) to define a relatively, and preferably surgically, sharp pointed apex 44 facilitating cutting of the incision in the animal’s skin by presenting a unified cutting edge. Accordingly, in this arrangement, the surgical tool 10 may be said to be “self-cutting”, in that advantageously an additional tool or instrument (such as a scalpel) is not required for making the incision in the animal’s skin. In an alternative arrangement the blades comprise blunt edges to define a non-cutting insertion tip 26.

[0078] The base 40 of each blade 38 is attached to the distal end 24 of the cannula 20 via a pivoting joint permitting each blade 38 to be selectively moved in such a manner for locating, selectively, the insertion tip 26 in a closed condition and an open condition. The pivot joint may be a self-retracting pivot joint resulting in that the blades 38 return to the particular condition that defines the insertion tip 26 after the implant 12 has left the surgical tool 10.

[0079] The arrangement of the blade(s) 38 is not limited in this regard. For example, in alternative arrangements, the blades 38 may be manufactured out of a resilient material. For example, each resilient blade 38 may be attached to the distal end 24 of the cannula 20 with the blades 38 being deformed as the implant 12 exists the cannula 20. Once the implant 12 has exited the surgical tool 10, the blades 38, due to their resilient properties, return to the original condition locating the insertion tip 26 into the closed condition. In other embodiments, the blades may be hinged, or manufactured out of a strong, malleable metal or other material, as appropriate, and may be suitably pliable or flexible.

[0080] The surgical tool 10 as shown in figure 6 comprises means for indicating to the surgeon, prior to insertion of the implant 12 into the animal’s body, the particular orientation that the implant 12 has when located within the surgical tool 10. In this respect, particular implants 12 may need to be oriented in a particular manner within the animal’s body. For example, the implant 12 may have a particular face (for example, the “up” face, see figure 7) that needs to be facing the skin below which the implant 12 will be located. By, the surgical tool 10, having means that indicate the particular orientation that the implant 12 has when inside the surgical tool 10, the surgeon can gain an understanding of how the implant 12 is oriented within the cannula 20. In this manner, the surgeon may orient the surgical tool 10 in such a manner so as to ensure that the implant 12 will be inserted correctly under the animal’s skin, in particular for example, in such a manner that the “up” side of the implant (opposite to the “down” side of the implant) faces the lower surface of the animal’s skin. An example of the indication means may be a marking 29 on the plunger (see figure 6) visible to the surgeon prior to insertion of the implant 12. Alternatively, the marking 29 may be on the cannula 20. In an embodiment the indicating means may comprise a tag provided on the surgical tool 10 to indicate orientation of the implant 12.

[0081] In the particular arrangement shown in the figures, the cross-section along the transverse plane of the cannula 20 is of polygonal configuration permitting using the surgical tool 10 for implanting implants 12 with also a polygonal (e.g. rectangular) transverse cross-section. However, in alternative arrangements, the cross-section along the transverse plane of the cannula 20 may have any type of configuration. For example, the surgical tool 10 may take any transverse cross-section depending on the shape of the implant 12 to be implanted in the animal’s body.

[0082] In a particular arrangement, the surgical tool 10 is configured to accommodate a 20 mm x 20 mm implant 12, or alternatively a 20 mm x 10 mm implant 12. However, the surgical tool 10 is not limited in this regard and may take any size depending on the size and shape of the implant 12 to be implanted in the animal’s body, in embodiments.

[0083] Moreover, the surgical tool 10 shown in the figures has been described as having a cutting tool 14. In an alternative embodiment of the invention, the surgical tool 10 may not include the insertion tip 26 comprising cutting edges. Instead, a scalpel blade (independent from the surgical tool 10) may initially be used for making the incision in the animal’s skin, and subsequently, the surgical tool 10 not including the insertion tip 26, is used for implanting the implant 12.

[0084] In operation, the surgeon, prior making the incision in the animal’s skin for insertion of the implant 12, proceeds to insert the implant 12 into the cannula 20 via the opening at the proximal end 22 of the cannula 20 making sure (if applicable depending on the particular type of implant 12 used) that when inserting the implant 12, the implant 12 is properly oriented such that the “up” face of the implant 12 coincides with the marking 29 on the surgical tool 10 (as shown in figure 6) indicating to the surgeon which is the “up” side of the surgical tool 10.

[0085] Once, the implant 12 has been inserted into the surgical tool 10, the surgeon may proceed with making the incision in the animal’s skin for insertion of the implant 12. For this, the surgeon may either use the cutting tool of the insertion tip 26 of the surgical tool 10 for making the incision or, alternatively, in case the surgical tool 10 does not include the cutting tool of the insertion tip 26, the surgeon may use a scalpel blade to make the incision in the animal’s skin.

[0086] At this stage the implant 12 (already contained in the surgical tool 10) may be inserted through the incision made in the animal’s skin for locating the implant 12 below the animal’s skin. This is done by inserting at least a portion of the insertion tip 26 into the incision to ensure the implant 12 enters the incision. In case, it is essential to properly orient the implant 12 such that “up” face of the implant 12 faces the lower surface of the skin, the surgeon, needs to ensure that the “up” side of the surgical tool faces the surgeon when applying the surgical tool 10 to the animal’s skin. In this manner, the implant 12 will enter the animal’s body with the implant’s “up” face facing the lower surface of the animal’s skin.

[0087] The surgeon inserts the implant 12 into the incision by applying a manual pushing force to the plunger 28 for moving the implant 12 through the distal end 24 of the cannula 20 and the insertion tip 26 (as the blades 38 separate). Once the implant 12 has been properly implanted in the animal’s body, the surgeon may remove the surgical tool 10 and proceed to heal the wound in the animal’s skin being a product of having made the incision for insertion of the implant 12 into the animal’s body.

[0088] Subsequently, the surgical tool may be cleaned or discarded in case it is a non-reusable surgical tool 10.

[0089] The surgical tool 10 has been described with reference to implanting an implant in an animal body. However, the surgical tool may be used in respect of any living body such as a human body, and also a deceased body, in embodiments.

[0090] It should be noted in the preceding description that like or the same reference numerals in different embodiments denote the same or similar features.

[0091 ] It will be appreciated that the described embodiment of the invention provides several advantages as highlighted and described earlier herein.

[0092] 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.

[0093] The present application claims priority from Australian Provisional Patent Application No. 2022901417, the contents of which are incorporated herein by reference in their entirety.