An apparatus for anchoring to biological tissue

Abstract

Disclosed is an apparatus 100 for anchoring to biological tissue. The apparatus 100 comprises a sleeve 110 configured to transition between a collapsed condition and an expanded condition. The sleeve 110 has a flexible body with an inner surface and an outer surface and a plurality of anchors integrally formed on the outer surface of the body. The 5 apparatus 110 further comprises an insert 120 that is configured to be at least partially inserted into the body of the sleeve 110 to transition the sleeve 110 from the collapsed condition to the expanded condition. In the collapsed condition, the sleeve 110 is configured for insertion through an incision 119. In the expanded condition, insertion of the insert 120 expands the body, thereby positioning the plurality of anchors in an outward, expanded 10 condition to exert pressure on surrounding biological tissue and anchor the sleeve 110 securely in place.

Description

[0001] An apparatus for anchoring to biological tissue FIELD OF THE INVENTION

[0002] The invention relates to an apparatus for anchoring to biological tissue. Especially, but not exclusively, the invention relates to an apparatus for anchoring and protecting biological tissue in minimally invasive surgical or other procedures.

[0003] BACKGROUND

[0004] In procedures such as liposuction and vaser-assisted liposuction, the insertion and repeated movement of cannulas through the incision can result in significant friction at the entry point. This friction can cause irritation, scarring, and, in patients with darker skin tones, hyperpigmentation. Over time, the repetitive trauma may also lead to the widening of the scar, complicating both the procedural outcome and post-operative recovery.

[0005] Beyond liposuction, the need for effective skin protection extends to chest tube insertions, where tubes are used to evacuate air, fluids, or pus from the pleural cavity following surgery or trauma. Chest tubes must be securely anchored to prevent dislodgement or migration during the patient’s movements or breathing. Traditionally, this is achieved by suturing the tube to the chest wall, a method that is time-consuming, prone to variability in fixation strength, and can increase the risk of infection or irritation at the suture site. Additionally, sutures introduce extra procedural steps and costs, making them less than ideal in emergency or resource-constrained scenarios.

[0006] In laparoscopic surgeries, stabilising access points for instruments presents another challenge. Devices may be employed to provide access to the abdominal cavity, but they require suturing to the abdominal wall for stability. This adds complexity and time to the procedure, increasing the risk of tissue damage or discomfort for the patient. Moreover, achieving a secure fixation while maintaining minimal invasiveness remains a persistent difficulty, particularly in surgical environments. A common issue across all these applications, whether as a skin protector, chest tube stabiliser, or surgical drain, is the secure and reliable anchoring of the apparatus to the tissue while minimising trauma. Any solutions require larger skin incisions to accommodate their anchoring mechanisms, can lead to greater tissue damage and extended recovery times. Improperly designed devices to minimise incision size may fail to provide sufficient anchoring strength, resulting in dislodgement or migration, compromising the efficacy of the procedure.

[0007] Furthermore, apparatus that rely on threaded features or similar, may increase friction during insertion and can exacerbate tissue irritation. Such apparatus may also be limited for use in specific procedure only, thus reducing their overall utility in diverse surgical or other medical settings.

[0008] OBJECT OF THE INVENTION

[0009] It is therefore an object of the present invention to provide an apparatus for anchoring to biological tissue and / or component(s) of such apparatus which overcomes or at least ameliorates some of the disadvantages described above, or which at least provides the public with a useful choice.

[0010] Additionally, or alternatively, it is an object of the present invention to provide a method of anchoring an apparatus or component(s) of the apparatus to biological tissue which overcomes or at least ameliorates some of the disadvantages described above, or which at least provides the public with a useful choice

[0011] BRIEF DESCRIPTION OF THE INVENTION

[0012] In a first aspect, the present invention resides in an apparatus for anchoring to biological tissue, the apparatus comprising:

[0013] a sleeve that is configured to transition between a collapsed condition and an expanded condition, the sleeve comprising a flexible (deformable) body having an inner surface and an outer surface, and a plurality of anchors integrally formed on the outer surface of the body; and

[0014] an insert that is configured to be at least partially inserted into the body of the sleeve to transition the sleeve from the collapsed condition to the expanded condition, wherein when in the collapsed condition the sleeve is configured for insertion through an incision and when in the expanded condition at least the plurality of anchors extends (i.e., expands) outwardly to exert pressure on surrounding tissue that is the biological tissue thereby anchoring the sleeve securely in place.

[0015] Preferably, the body of the sleeve is elastic or deformable, thereby allowing the body and the plurality of anchors to collapse inwardly during insertion through the incision and expand outwardly when acted upon by the insert.

[0016] Preferably, the incision is a skin incision.

[0017] Preferably, the insert is configured to apply a radial force to the inner surface of the flexible body, the radial force expanding the body so that the anchors move outward with the body into the expanded condition.

[0018] Preferably, the insert is configured to apply a radial force along the inner surface of the flexible body, causing the body to unfurl or stretch outwardly so that as the body expands, the plurality of anchors is drawn outward, transitioning to the expanded condition.

[0019] Preferably, the sleeve is made of an elastomeric material, a metallic material or a percaline.

[0020] Preferably, the sleeve is made of a silicone material.

[0021] Preferably, the plurality of anchors is made out of same material as the body. Preferably, a rigidity’ of the plurality of anchors is same as a rigidity’ of the body. Preferably, a rigidity of the plurality of anchors is less than a rigidity of the body. Preferably, the inner and outer surface are smooth or non-abrasive.

[0022] Preferably, the sleeve has no grooves and / or holes.

[0023] Preferably, the plurality of anchors is arranged the outer surface of the body to expand to a plurality of directions when in the expanded condition.

[0024] Preferably, the plurality of anchors comprises at least two flexible (deformable) anchors.

[0025] Preferably, the plurality of anchors comprises at least four flexible (deformable) anchors.

[0026] Preferably, the plurality of anchors is spaced apart from one another.

[0027] Preferably, each of the plurality of anchors has blunt edges or rounded comers for preventing tissue damage.

[0028] Preferably, each of the plurality of anchors has at least one blunt edge or rounded comer for preventing tissue damage.

[0029] Preferably, the body of the sleeve has at least one rounded comer (for preventing tissue damage).

[0030] Preferably, the body of the sleeve has rounded corners (for preventing tissue damage).

[0031] Preferably, each of the anchor is of substantially aerofoil shape.

[0032] Preferably, the plurality’ of anchors is in the form of a plurality of wings.

[0033] Preferably, the plurality of anchors is arranged symmetrically around the body. Preferably, the plurality’ of anchors is arranged symmetrically around the body in multiple directions Preferably, the plurality of anchors is arranged symmetrically around the body in at least four columns.

[0034] Preferably, the plurality of anchors is arranged symmetrically around the body in at least four directions.

[0035] Preferably, the body is a tubular, hollow cylindrical structure for receiving the insert when the insert is inserted into the body.

[0036] Preferably, the body is configured to flex to conform to the contours of surrounding tissue.

[0037] Preferably, the sleeve or the body of the sleeve is of a flexible (deformable) structure (e.g. balloon-like flexible / deformable structure) that is configured to take shape and rigidity upon insertion of the insert.

[0038] Preferably, the sleeve or the body of the sleeve is made of a flexible (deformable) material that is configured to adopt a predefined shape upon insertion of the insert, transitioning from the collapsed condition where the sleeve of the body of the sleeve is in a substantially flattened configuration to the expanded condition where the sleeve or the body of the sleeve is in a substantially tubular, expanded configuration with the plurality of anchors deployed outwardly for anchoring.

[0039] Preferably, the sleeve or the body of the sleeve is made of a flexible (deformable) material configured to assume a substantially tubular shape upon insertion of the insert, the sleeve or body being substantially flattened in the collapsed condition and the plurality of anchors being positioned outwardly in the expanded condition.

[0040] Preferably, the insert is shaped to progressively expand the plurality of anchors as the insert slides through the sleeve when inserted into the body of the sleeve.

[0041] Preferably, the insert is shaped so that, as the insert slides through the sleeve, the insert progressively expands the body of the sleeve, thereby positioning the plurality of anchors in their outward, expanded condition. Preferably, the plurality of anchors is configured to be and remain flush with the outer surface of the body in the collapsed condition to minimise the dimension for insertion through the incision.

[0042] Preferably, in the collapsed condition, plurality’ of anchors is configured to minimise friction during insertion through the incision.

[0043] Preferably, the body comprises a tapered tip or tip with bevelled edges (for facilitating insertion through the incision).

[0044] Preferably, the anchors are made of a flexible (deformable), shape memory material that transitions to the expanded condition upon release.

[0045] Preferably, when in the expanded condition, each of the plurality of anchors is configured to extend (expand) at an angle between substantially 70 degrees to substantially 90 degrees from the body.

[0046] Preferably, when in the expanded condition, each of the plurality of anchors is configured to extend (expand) at an angle of substantially 90 degrees from the body.

[0047] Preferably, in the collapsed condition, the body and the plurality of anchors is configured to collectively form a reduced profile for allowing insertion of the body and the plurality of anchors through the incision that is smaller than cross-sectional dimensions of the body and the plurality anchors in the expanded condition.

[0048] Preferably, the body is configured to extend (expand) longitudinally along a longitudinal axis and maximum cross-sectional dimension of the body and the plurality of anchors measured orthogonal to the longitudinal axis of the body and anchors in the collapsed condition is smaller than the maximum cross-sectional dimensions of the body and anchors in the expanded condition.

[0049] Preferably, the plurality of anchors is configured to anchor into subcutaneous tissue, the subcutaneous tissue being the biological tissue. Preferably, the sleeve is configured to be inserted into the biological tissue through the incision formed at a layer of skin.

[0050] Preferably, the apparatus is configured to be inserted into the biological tissue through the incision formed at a layer of skin.

[0051] Preferably, the insert is made of a rigid material.

[0052] Preferably, the insert is made of a material having the rigidity or hardness that is sufficient to provide consistent force to allow the sleeve to transition from the collapsed condition to the expanded condition.

[0053] Preferably, the insert is made out of a hard plastic or a metal.

[0054] Preferably, at least a portion of the insert is tapered to allow gradual expansion of the body and anchors as the insert is advanced within the body.

[0055] Preferably, the insert has a rigid construction with a smooth or non-abrasive outer surface.

[0056] Preferably, the insert comprises a cylindrical structure with a hollow interior for guiding and aligning the sleeve during deployment.

[0057] Preferably, the insert has smooth or non-abrasive edges to minimise friction during insertion into the sleeve.

[0058] Preferably, the insert has the rounded corners for preventing damage to the tissue or the sleeve.

[0059] Preferably, the insert has at least one rounded corner for preventing damage to the tissue or the sleeve.

[0060] Preferably, the insert comprises a gripping surface or texture on its flange. Preferably, the hollow interior of the insert is dimensioned or configured to allow at least one medical device (e.g., drainage tube(s), cannula(s) or surgical instrument(s)) inserted within the hollow interior.

[0061] Preferably, the insert and / or sleeve is made out of a reusable material.

[0062] Preferably, the sleeve comprises a flange preferably a substantially circular flange, at its base that is configured to abut to outside of the skin of the patient when in use, thereby preventing over-insertion of the sleeve inside the incision.

[0063] Preferably, the insert comprises a flange, preferably a substantially circular flange, at its base for preventing over-insertion into the sleeve.

[0064] Preferably, the flange of the sleeve comprises at least one first engagement member. and the flange of the insert comprises at least one second engagement member, wherein the first engagement member and the second engagement member are configured to engage with each other to lock, preferably temporarily lock, the insert within the sleeve when the insert is inserted into the body of the sleeve.

[0065] Preferably, the flange of the insert comprises engagement means for attachment to an external device.

[0066] Preferably, the cylindrical structure of the insert comprises a tapered region at or near an end that is distal from the flange of the insert (e.g., for allowing easy insertion into the body of the sleeve or to minimising resistance during insertion of the insert into the sleeve).

[0067] Preferably, the sleeve comprises a lid that is a removable or detachable, wherein the lid when in closed configuration is configured to conceal the hollow interior of the insert at its end that is proximal to the incision or proximal to the flange of the insert.

[0068] Preferably, the sleeve comprises a lid that is a removable or detachable, wherein the lid when in closed configuration is configured to conceal the hollow' interior of the insert or interior of the body of the sleeve at its end that is located proximal to the incision, or proximal to the flange of the insert or the flange of the sleeve. Preferably, the lid is hingedly mounted to the flange of the insert or to the flange of the sleeve.

[0069] Preferably, the apparatus further comprises an introducer for insertion and alignment of the sleeve and / or the insert into the incision when in use, the introducer comprising: an elongated cylindrical body extending longitudinally from a first end to a second end that is opposite the first end;

[0070] a first section extending longitudinally from the first end towards the second end, the first end suitable for providing grip and control of manual manipulation when the introducer is in use;

[0071] a second section extending longitudinally from the first section towards the second end, the second section suitable for guiding the sleeve and / or insert during insertion; and wherein, the diameter of the first section is larger than the diameter or the second section.

[0072] Preferably, the introducer comprises a bevelled transition between the first and second sections.

[0073] Preferably, at least the second end of tire introducer is rounded.

[0074] In a second aspect, the present invention resides in an apparatus for anchoring to biological tissue, the apparatus comprising:

[0075] a sleeve configured to transition between a collapsed condition and an expanded condition, the sleeve comprising a flexible (deformable) body having an inner surface and an outer surface, and a plurality of anchors integrally formed on the outer surface of the body and oriented to move radially outward when the body transitions to the expanded condition; and

[0076] an insert that is configured to be at least partially received within the body of the sleeve and configured to at least partially engage with the inner surface of the body thereby causing radial outward displacement of the body to transition the sleeve from the collapsed condition to the expanded condition,

[0077] wherein when in the collapsed condition the sleeve is sized for insertion through an incision, and wherein in the expanded condition the plurality of anchors are positioned outwardly relative to the sleeve.

[0078] Preferably, the incision is the skin incision.

[0079] Preferably, the sleeve is the sleeve of the apparatus as defined in any one of the statements of the first aspect.

[0080] In a third aspect, the present invention resides in a sleeve for use in anchoring to a biological tissue, the sleeve comprising:

[0081] a flexible (deformable) body comprising a plurality of anchors integrally formed on an outer surface of the body, wherein the sleeve is configured to transition between the collapsed condition and the expanded condition wherein in the collapsed condition sleeve is configured for insertion through an incision and wherein in the expanded condition, at least the plurality of anchors extend (expand) outwardly to exert pressure on surrounding tissue that is the biological tissue thereby anchoring the sleeve securely in place.

[0082] Preferably, in the collapsed condition, the body and the plurality of anchors are configured to collectively be smaller in size (or have a reduced profile) than their size or profile in the expanded condition, allowing insertion of the body and the plurality of anchors through an entry point or a skin entry point that is smaller than cross-sectional dimensions of the body and the plurality anchors in the expanded condition.

[0083] Preferably, the body is configured to extend longitudinally along a longitudinal axis and maximum cross-sectional dimension of the body and the plurality of anchors measured orthogonal to the longitudinal axis of the body and anchors in the collapsed condition is smaller than the maximum cross-sectional dimensions of the body and anchors in the expanded condition. Preferably, the sleeve is the sleeve of the apparatus as defined in any one of the statements of the first or second aspect. In a fourth aspect, the present invention resides in an insert that is configured to be used with a sleeve, the sleeve being an expandable sleeve that is configured to transition between a collapsed condition and an expanded condition, the sleeve comprising a flexible (deformable) body having an inner surface and an outer surface with a plurality of anchors integrally formed on the outer surface of the body, wherein the insert is configured to be at least partially inserted into the body of the sleeve to transition the sleeve from the collapsed condition to the expanded condition, wherein when in the collapsed condition the sleeve is configured for insertion through an incision and when in the expanded condition at least the plurality of anchors extend (expand) outwardly to exert pressure on surrounding tissue that is the biological tissue thereby anchoring the sleeve securely in place.

[0084] Preferably, the plurality of anchors is oriented to move radially outward when the body transitions to the expanded condition.

[0085] Preferably, the insert is shaped to progressively expand the plurality of anchors as it slides through the sleeve when inserted into the body of the sleeve.

[0086] Preferably, the insert is the insert of the apparatus as defined in any one of the statements of the first or second aspect.

[0087] In a fifth aspect, the present invention resides in an introducer for insertion and alignment of a sleeve and / or an insert into the incision when in use, the introducer comprising:

[0088] an elongated cylindrical body extending longitudinally from a first end to a second end that is opposite tire first end;

[0089] a first section extending longitudinally from the first end towards the second end, the first end suitable for providing grip and control of manual manipulation when the introducer is in use; a second section extending longitudinally from the first section towards the second end, the second section suitable for guiding the sleeve and / or the insert during insertion; and

[0090] wherein, the diameter of the first section is larger than the diameter or the second section.

[0091] Preferably, the introducer comprises a bevelled transition between the first and second sections.

[0092] Preferably, the second end is rounded.

[0093] Preferably, the introducer is made of a rigid material.

[0094] Preferably, the introducer is made out of a hard plastic or a metal.

[0095] Preferably, the introducer has a rigid construction with a smooth or non-abrasive outer surface.

[0096] Preferably, the introducer is the introducer of the apparatus as defined in any one of the statements of the first or the second aspect.

[0097] In a sixth aspect, the present invention resides in a kit set for an apparatus of any one of the statements above, comprising:

[0098] a sleeve that is configured, in use, to transition between a collapsed condition and an expanded condition, the sleeve comprising a flexible (deformable) body having an inner surface and an outer surface with a plurality of anchors integrally formed on the outer surface of the body; and

[0099] an insert that is configured, in use, to be at least partially inserted into the body of the sleeve to transition the sleeve from the collapsed condition to the expanded condition, wherein when in the collapsed condition the sleeve is configured for insertion through an incision and when in the expanded condition at least the plurality of anchors extend (expand) outwardly to exert pressure on surrounding tissue that is the biological tissue thereby anchoring the sleeve securely in place.

[0100] Preferably, the kit set further comprises an introducer for insertion and alignment of the sleeve and / or insert into the incision when in use, the introducer comprising: an elongated cylindrical body extending longitudinally from a first end to a second end that is opposite the first end; a first section extending longitudinally from the first end towards the second end, the first end suitable for providing grip and control of manual manipulation when the introducer is in use; a second section extending longitudinally from the first section towards the second end, the second section suitable for guiding the sleeve and / or the insert during insertion; and wherein, the diameter of the first section is larger than the diameter or the second section.

[0101] Preferably, the kit set is the kit set of the apparatus as defined in any one of the statements of the first or second aspect.

[0102] In a seventh aspect, the present invention resides in a method of anchoring a sleeve to biological tissue, the method comprising:

[0103] providing a sleeve in a collapsed condition, the sleeve comprising a flexible (deformable) body with a plurality of anchors integrally formed on an outer surface of the body;

[0104] inserting the sleeve in the collapsed condition through an incision into the biological tissue;

[0105] inserting an insert at least partially into the body of the sleeve thereby transitioning the sleeve to an expanded condition with the plurality of anchors extending (expanding) outwardly to exert pressure on the surrounding biological tissue, thereby anchoring the sleeve securely in place.

[0106] Preferably, the method comprises attaching the sleeve in a collapsed condition over an introducer and advancing the sleeve through the incision using the introducer. Preferably, the method comprises inserting the insert through the introducer to transition the sleeve from the collapsed condition to the expanded condition.

[0107] Preferably, the method comprises removing the introducer after tire sleeve is securely anchored in the biological tissue.

[0108] Preferably, the method comprises removing the introducer and the insert after the sleeve is securely anchored in the biological issue.

[0109] Preferably, the method is a method of using the apparatus as defined in any one of the statements of the first or second aspect.

[0110] Preferably, the sleeve is the sleeve as defined in any one of the above statements. Preferably, the insert is the insert as defined in any one of the above statements.

[0111] Preferably, the introducer is the one in defined in any one of the above statements. In an eighth aspect, the present invention resides in a use of apparatus as defined in any one of the statements of the first or second aspect.

[0112] In any of the above aspects, one or more statements relating to any one aspect may equally apply to any other aspect.

[0113] As used hereinbefore and hereinafter and unless stated otherwise, the word 'for is to be interpreted to mean only 'suitable for', and not for example, specifically 'adapted' or 'configured' for the purpose that is stated.

[0114] As used hereinbefore and hereinafter and unless stated otherwise ‘and / or’ means ‘and’ or ‘or’ or both.

[0115] As used hereinbefore and hereinafter and unless stated otherwise, “(s)”, following a noun means the plural and / or singular forms of the noun.

[0116] As used hereinbefore and hereinafter and unless stated otherwise, ‘mounted’ or ‘coupled’ means ‘directly or indirectly or detachably mounted’ or ‘directly or indirectly or detachably coupled’. For example, it may include directly mounted or coupled but may also include mounted or coupled using / through another member(s) or component(s) or detachably mounted or coupled.

[0117] As used hereinbefore and hereinafter and unless stated other “flexible” body includes a body that is deformable in a reversible manner sufficient to allow the sleeve to transition between its collapsed and expanded conditions. The terms “flexible,” “deformable,” “resilient,” and “compliant” may be used interchangeably herein unless otherwise specified.

[0118] For purposes of the description hereinafter, the terms "‘upper”, “lower”, ’‘right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal” and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following description are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.

[0119] It is acknowledged that the term ‘comprise’ may, under varying jurisdictions, be attributed with either an exclusive or an inclusive meaning. For the purpose of this specification, and unless otherwise noted, the term ‘comprise’ and variations such as ‘comprises', comprising’, comprised’, and the like shall have an inclusive meaning, that is, to include not only the features, elements, integers, or steps explicitly listed, but also others that do not preclude the presence of additional, unlisted features, elements, integers, or steps.

[0120] It is known to those with skill in the art of patenting, that the word ‘substantially’ can in some instances, be used to broaden a term. It should be stated that, in this specification, use of the word ‘substantially’ wath a term, to define a feature(s), gets all the benefit (i.e., the benefit of broadening) afforded by the use of the word ‘substantially’, and also includes within its scope feature(s) being that the term exactly (without broadening). For example, if a feature is described / defined in this specification as being ‘substantially vertical’, then that includes, within its scope, the feature being ‘close’ to vertical (in so far as the word ‘substantially’ is deemed to broaden the term ‘vertical’), and also includes within its scope the features being ‘exactly’ vertical.

[0121] 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 applicants reserve the right to challenge the accuracy and pertinency 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 form part of the common general knowledge in the art, in Australia or in any other country. BRIEF DESCRIPTION OF THE DRAWINGS

[0122] Further aspects of the present invention will become apparent from the following description which is given by way of example only and with reference to the accompanying drawings in which:

[0123] Figure 1 shows a sleeve of an apparatus according to a first example of the present invention in a collapsed condition.

[0124] Figure 2 shows the sleeve of the Figure 1 in an expanded condition.

[0125] Figure 3 shows an insert of the apparatus of the first example of the present invention.

[0126] Figure 4 shows an introducer of the apparatus of the first example of the present invention.

[0127] Figures 5A to 5D sequentially show the use of the apparatus of the first example of the present invention. Figure 6 shows an example of an example of apparatus according to second example of the present invention when in use

[0128] Figure 7 shows an end view of Figure 6.

[0129] Figure 8 shows a cross-sectional view of Figure 6 along longitudinal axis A-A. Figure 9 shows a sleeve of an apparatus according to a third example of the present invention.

[0130] Figure 10 shows an insert of the apparatus according to a third example of the present invention.

[0131] Figure 11 shows an introducer of the apparatus according to a third example of the present invention.

[0132] DETAILED DESCRIPTION

[0133] There is a need for an apparatus that integrates robust tissue anchoring with minimal invasiveness and versatility across multiple medical applications. Such an apparatus could simplify medical or laboratory procedures, reduce tissue trauma, and provide effective solutions for liposuction, chest tube insertion, laparoscopic surgeries, surgical drainage and / or many other surgical and / or medical procedures.

[0134] An example of an apparatus (100) according to the present invention will now be described with reference to Figures 1-4 and 5A-5D. The apparatus (100) may alternatively be referred to as an assembly.

[0135] The apparatus (100) is configured to anchor to organic tissue i.e., biological tissue. The biological tissue may be part of a subject, wherein the subject is preferably a human but may alternatively be a non-human animal. Non-human animals may include mammals, reptiles, or avian species (e.g., birds). In some embodiments, the biological tissue may be a biological sample in a laboratory or experimental setting. The apparatus (100) is suitable for use in vivo, where the biological tissue is within a living subject, or in vitro, where the biological tissue is part of an isolated biological sample in a laboratory or experimental setting.

[0136] The sleeve (110) is configured to transition between a collapsed condition as shown in Figure 1 and an expanded condition (i.e., fully expanded condition) as shown in Figure 2. The sleeve (110) comprises a flexible body (112) having an inner surface and an outer surface (116). The sleeve further comprises a plurality of anchors (118), most preferably in the form of wings. Anchors (118) are integrally formed on the outer surface (116) of the body (112). For the avoidance of doubt, a “flexible” body (112) includes a body that is deformable in a reversible manner sufficient to allow the sleeve to transition between its collapsed and expanded conditions. The terms “flexible,” “deformable,” “resilient,” and “compliant” may be used interchangeably herein unless otherwise specified.

[0137] An insert (120) is configured to be at least partially inserted into the body (112) of the sleeve (110) to transition the sleeve (110) from the collapsed condition as shown in Figure 1 to the expanded condition as shown in Figure 2. Removal of the insert (120) from the body (112) of the sleeve (110) may cause the sleeve (110) to transition from the expanded condition as shown in Figure 2 to the collapsed condition as shown in Figure 1. In the collapsed condition, the sleeve (110) is configured for insertion through the incision (119) formed on the skin of a patient. In the expanded condition, at least the anchors (118) extend / expand outwardly to exert pressure on surrounding tissue, i.e., the biological tissue thereby anchoring the sleeve (110) securely in place.

[0138] By integrating the flexible body (112) and anchors (118) into a unified structure, the apparatus (100) of the present invention allows an effective anchoring without the need for sutures or threaded components, which can cause tissue damage or increase complexity during medical procedure. Furthermore, the insert (120) can facilitate controlled expansion of the sleeve (110), by allowing that the anchoring anchors are deployed evenly and exert consistent pressure on the surrounding tissue.

[0139] As a skilled person will appreciate the insertion of the insert (120) into the sleeve (110) may allow the anchors (118) to expand by applying outward pressure to the inner surface of the flexible body, causing the anchors (118) to transition from their collapsed condition to the expanded condition.

[0140] In one example, the anchors (118) may expand through a mechanism wherein the flexible body of the sleeve ( 110) is inherently elastic or deformable, allowing it to collapse inwardly during insertion through the incision (119) and expand outwardly when acted upon by the insert (120). The insert (120) may apply a radial force along / to the inner surface (114) of the flexible body, causing it to unfurl or stretch outwardly. As the body (112) expands, the integrally formed anchors (118) may be drawn outward, transitioning to the expanded condition. This mechanism can allow the anchors to deploy smoothly and consistently thereby allowing for precise anchoring without requiring additional moving parts or complex deployment systems, thereby simplifying both the design and operation of the apparatus (100).

[0141] Therefore, it can be appreciated that the apparatus (100) may comprise a sleeve (110) and an insert (120). The sleeve (110) may be configured to transition between a collapsed condition and an expanded condition, The sleeve (110) may comprise a flexible body (112) having an inner surface and an outer surface, and a plurality of anchors (118) integrally formed on the outer surface of the body (112) and oriented to move radially outward when the body transitions to the expanded condition. The insert (120) may be configured to be at least partially received within the body (112) of the sleeve (110) and configured to at least partially engage with the inner surface of the body (112) thereby causing radial outward displacement of the body (112) to transition the sleeve (110) from the collapsed condition to the expanded condition, In the collapsed condition the sleeve (110) is sized for insertion through an incision, and in the expanded condition the anchors (118) are positioned outwardly relative to the sleeve.

[0142] In one example, the insert (120) may comprise protrusions or similar designed to engage with corresponding structures on the inner surface (114) of the sleeve (110), mechanically pushing the anchors outward upon insertion. In one example, the insert (120) may comprise / be of a tapered or conical shape that progressively increases in diameter, gradually forcing the flexible body (110) and anchors (118) outward as it is advanced.

[0143] The sleeve (110) may be made of an elastomeric material, metallic material / metal (e.g. aluminium), light weight cotton fabric (most preferably, percaline), silicone material / silicone or a combination thereof. The sleeve may be made from many other suitable material(s). Preferably, the anchors (118) are made from the same material as the body (112). Tire rigidity of the anchors (118) may be the same as the rigidity of the body (112) thereby simplifying the manufacturing process. Alternatively, the rigidity of the anchors (118) may be less than the rigidity of the body, thereby allowing the anchors to flex more easily during deployment and reducing the force required for expansion and minimising the risk of tissue damage during anchoring.

[0144] The sleeve (110) may have smooth or non-abrasive inner and outer surfaces tor thorough cleaning and sterilisation, making the apparatus suitable for reuse in multiple procedures. As a skilled person will appreciate, the smooth or non-abrasive surfaces can minimise the accumulation of any contaminants or other matter thereby reducing the risk of infection. Additionally, the sleeve (110) may not have any grooves and / or holes thereby further improving its sterilisability by eliminating areas where contaminants can become trapped and allows the sleeve (110) to be easily cleaned using conventional sterilisation techniques, such as autoclaving or chemical disinfection.

[0145] The anchors (118) may be arranged on the outer surface (116) of the body (112) to expand outwardly in multiple directions when in the expanded condition, providing secure anchoring from multiple areas. There may be at least two flexible anchors, or at least four flexible anchors. In some embodiments, there may be more than nine anchors. Tire anchors (118) may be spaced apart from one another thereby allowing the pressure to be distributed evenly on the surrounding tissue. The anchors (118) may be arranged on the body in four columns on four sides. This can allow anchoring in four different directions. Each of the anchors (118) may have blunt edge(s) / rounded comer(s). Having blunt edge(s) / rounded comer(s) as opposed to shaped edge(s) / comer(s) can prevent tissue damage during deployment thereby reducing injury to subjects. In one example, each of the anchors (118) may be of aerofoil shape for the same reason. The anchors (118) may be arranged symmetrically around the body (112) which can allow uniform anchoring.

[0146] The anchors (118) may rely solely on the pressure exerted by the insert to transition from the collapsed condition to the expanded condition, thereby removing the need for additional moving parts or complex mechanisms. The body (112) of the sleeve (110) may be a tubular, hollow cylindrical structure for receiving the insert (120), The body (112) may be configured. By being flexible, the body can conform to the contours of the surrounding tissue, allowing the sleeve to be used in different parts of body or anatomy of the patient. The sleeve (110) or the body (112) of the sleeve (110) may have a balloon-like flexible structure, which remains collapsed during insertion and takes a shape and rigidity when the insert is introduced.

[0147] The sleeve (110) or the body (112) of the sleeve may be made of a flexible material configured to adopt a predefined shape upon the insertion of the insert (120). In the collapsed condition, the sleeve (110) or the body (112) of the sleeve (110) may be in a substantially flattened configuration, thereby allowing for easy insertion through an incision (119) (e.g., skin incision) with minimal profile. Upon insertion of the insert. (130), the sleeve (110) or the body (112) may transition to an expanded condition, forming a substantially tubular, expanded configuration where the anchors (118) deploy outwardly from the outer surface of the body (110), providing anchoring by exerting pressure on the surrounding tissue. Thus, the sleeve (110) or the body (112) of the sleeve (110) may be made of a flexible material configured to form a substantially tubular shape upon insertion of the insert. The sleeve or body may be substantially flattened in the collapsed condition and the anchors (118) may be positioned outwardly in the expanded condition

[0148] The insert (120) may be shaped to progressively expand the anchors (118) or the body (112) and the anchors ( 118) as it slides through the sleeve (110) when inserted into the body (112) of the sleeve (110). In other words, the insert (120) may be shaped so that, as the insert (120) slides through the sleeve (110), the insert progressively expands the body of the sleeve, thereby positioning the anchors (118) in their outward, expanded condition. In one embodiment, the anchors (118) may flush or substantially flush with the outer surface of the body in the collapsed condition thereby minimising the dimension for insertion through the skin incision. This means the incision (119) can be much smaller.

[0149] In the collapsed condition, anchors (118) may be configured to minimise friction during insertion through the incision (119). Minimising the friction can lead to reduction in tissue trauma.

[0150] The body (112) may comprise a tapered tip or tip with bevelled edges for allowing easy insertion through tire skin incision. The anchors may be made of a flexible, shape memory material that transitions to the expanded condition upon release.

[0151] When in the expanded condition, each of the anchors (118) may be configured to extend outwardly from the body at an angle between substantially 70 degrees and substantially 90 degrees. This range allows the anchors to exert sufficient pressure on the surrounding tissue for secure anchoring. In a preferred embodiment, when in the expanded condition, each of the anchors (118) extends at substantially 90 degrees from the body.

[0152] In the collapsed condition, the body (112) and the anchors (118) may be configured to collectively form a reduced profile. This allows allowing insertion of the body (112) and the anchors (118) through a skin entry point, i.e., incision (119) that is smaller than cross- sectional dimensions of the body (112) and the anchors (118) in the expanded condition.

[0153] The body (112) may be configured to extend longitudinally along a longitudinal axis. " Die maximum cross-sectional dimension of the body (112) and the anchors (118) that is measured orthogonal to the longitudinal axis of the body (112) and anchors (118) in the collapsed condi tion may be smaller than the maximum cross-sectional dimensions of the body (112) and anchors (118) in the expanded condition.

[0154] The anchors (118) may be is configured to anchor into subcutaneous tissue.

[0155] Tire insert (120) may be made of a rigid material such as hard plastic or a metal. The insert (120) may be made of a material having the rigidity or hardness that is sufficient to provide consistent force to allow the sleeve to transition from the collapsed condition to the expanded condition.

[0156] At least a portion of the insert (120) may be tapered for allowing gradual expansion of the body (112) and anchors (118) as it is advanced. The insert (120) may comprise a tapered tip or tip with bevelled edges (124) for allowing easy insertion through the incision (108).

[0157] The insert (120) may have rigid construction with a smooth or non-abrasive outer surface. There may be no grooves, holes or similar. Having a smooth or non-abrasive surface can further help prevent damage to the inner surface (114) of the sleeve (110). Further, it may allow for reuse and easy sterilisation.

[0158] The insert (120) may comprise a cylindrical structure (122) with a hollow interior for guiding and align the sleeve during deployment. The insert (120) may have smooth or non- abrasive edges to minimise friction during insertion into the sleeve (110), more specifically, into the body (112) of the sleeve (110). 'The sleeve (110) may' be reusable, i.e., made out of a reusable material.

[0159] The insert (120) may comprise a gripping surface or texture on its flange (121). This can improve manual handling, particularly during the insertion and removal of the insert (120). The insert (120) may be reusable, i.e., made out of a reuseable material.

[0160] The hollow interior, which is the inner surface, of the insert (120) may be dimensioned or configured to allow medical devices such as but not limited to drainage tubes or surgical instruments to be inserted within the hollow interior. For example, in laparoscopic procedures, the hollow' interior may serve as a channel for introducing and aligning laparoscopic instruments, such as trocars, cannulas, cameras, or other surgical tools, into the surgical site. Additionally, the presence of the insert (120) minimises the risk of rubbing or injury' to the surrounding tissue during instrument insertion and manipulation. By¬ providing a smooth, protective pathway, the insert (120) prevents direct contact between the instruments and the tissue, reducing the chances of trauma, irritation, or damage, thereby providing a safer and more controlled surgical process. Additionally, use of such insert (12.0) can also prevent direct rubbing of instruments against the inner surface (114) of the sleeve (110) thereby reducing the risk of damage to the sleeve (110) during procedures. Also, by being located inside the body (112) of the sleeve (110), the insert (120) can function as a protective barrier between the instrument(s) and the sleeve (110) thereby minimising unnecessary' movement or deviation of mstrument(s) within the sleeve (110). In that way, the insert (120) can reduce the chances of instruments causing pressure, friction, or unintended trauma to the surrounding tissue during the procedure.

[0161] The sleeve (110) may comprise a flange (111) which may also be referred to as a sleeve flange (111). The flange (111) may be a substantially circular flange. The flange (111) may be located at the base of the sleeve (110). The flange (111) may be configured to abut the external surface of tire patient's skin (117) during use. This flange (117) limits the insertion depth of the sleeve (120) into the incision (U )), maintaining proper positioning of the sleeve (110).

[0162] Tire insert. (120) may comprise a flange (121) which may be a substantially circular flange. This flange (121) of the insert may also be referred to as an insert flange (121). This flange (121) may be located at the base of tire insert which may be configured to configure d to limit the depth of insertion of the insert (120) into the sleeve ( 110). The flange (121) may serve as a physical stop that prevents the insert from being pushed too far into the sleeve (110), maintaining proper insertion and functionality of the apparatus (100).

[0163] Hie flange (111) of the sleeve (100) may comprise at least one first engagement member, and the flange (121) of the insert (100) comprise at least one second engagement member. The first engagement member and the second engagement, member may be configured to engage with each other to lock, preferably temporarily lock, the insert (120) within the sleeve (100) when the insert (100) is inserted into the body (112) of the sleeve (100). Ihis can further prevent unintended movement of the insert (100) when positioned within the sleeve (100). For example, the first engagement member may be a groove, notch, clip or similar while the second engagement member may be a protrusion, tab, or complementary clip or similar. These features members may be configured to interlock or fit together when the insert (120) is positioned inside the body (112.) of the sleeve (110), creating a temporary' locking mechanism. In one example, a tab on the flange (121) of the insert (120) may snap into a groove on the flange (111) of the sleeve (110), holding the insert securely in place during deployment. Alternatively, the engagement members may involve friction fit or a twist-and-lock mechanism, where rotational motion secures the insert (120) within the sleeve (110). Many other suitable engagement members may be possible. It is to be noted that the engagement members are optional and the sleeve (110) may snugly receive the insert (120) within the body (112) and this may also facilitate unintentional movement of the insert (120) when positioned within the body (112) of the sleeve (110).

[0164] In one example, the flange (121) of the insert may comprise engagement means for attachment to an external device. One none limiting example of such external device may be a tube or reservoir such as ostomy pouch or surgical drains configured to manage bodily fluids or waste during medical procedures. Such engagement means may comprise snap-fit connector, adhesive surface or many other suitable means for engaging with external device.

[0165] " Die cylindrical structure (122) of the insert may comprise a tapered region at or near an end (124) that is distal from the flange (121) of the insert (120). Such a design can reduce resistance and friction during insertion thereby facilitating easy insertion of the cylindrical structure (122) into the sleeve (110)

[0166] Hie sleeve (110) or the insert (120) may comprise a lid that is removable or detachable. When in a closed configuration, the lid may be is configured to conceal the hollow interior of the insert (120) at its end (124) that is proximal to the incision (119) or proximal to the flange (121) of the insert (120). Tire lid may be hingedly mounted to the flange (121) of the insert (120) or the flange (111) of the sleeve (110), allowing the lid to pivot between an open and closed position.

[0167] In the closed configuration, the lid may provide a protective barrier that prevents the entry of contaminants, debris, or fluids into the hollow interior before or during the medical procedure. Similarly, depending upon the application, the lid can also prevent bodily fluids from egressing from the hollow interior. This feature can improve sterility and reduce the risk of infection. The hinge mechanism can allow for easy operation, allowing the lid to be opened when access to the hollow interior is required and closed again if needed. The removable or detachable nature of the lid provides additional flexibility, allowing it to be replaced or discarded depending on procedural requirements. Figure 6 show's an example of an apparatus (200) according to one example of the present invention with lid (225) located at the flange (211) of the sleeve (210). The embodiment of the sleeve (110) of Figure 1 may also have similar lid. Alternatively, the flange (221) of the insert (220) may- have such a lid.

[0168] In one example, the lid may be is configured to conceal the hollow' interior structure of body (112) at its end that is proximal to the incision (119) or proximal to the flange (111) of the sleeve (110).

[0169] The flange (111) of the sleeve (110) may be made from a flexible metallic material / metal (e.g. aluminium), light weight cotton fabric (most preferably, percaline), silicone material / silicone or a combination thereof or from many other suitable rnaterial(s) The apparatus (100) may further comprise an introducer (130) for the insertion and alignment of the sleeve into the incision (119) during use. The introducer (130) may comprise an elongated cylindrical body extending longitudinally from a first end (131) to a second end (133) that i s opposite the first end ( 131 ). The first section ( 132) of the introducer (130) may extend longitudinally from the first end (131) towards the second end (133) and may be designed with a larger diameter, making it suitable for providing grip and control or manual manipulation during use. This first section (132) may allow the user to handle the introducer (130) securely, providing stability and precision while guiding the sleeve (110) through the incision (119). The second section (134) of the introducer (130) may extend longitudinally from the first section (132) towards the second end (133) and may-have a smaller diameter than the first section (134). This smaller diameter may be specifically configured to guide the sleeve (110) during its insertion into the incision (119). The difference in diameters between the first section (132) and second sections (134) can prevent the sleeve (110) from being over-inserted and maintain alignment throughout the medical procedure. In addition, or alternative to guiding the sleeve (110), tire introducer (130) may also facilitate the insertion of the insert (120) into the sleeve (110) once the sleeve has been positioned within the incision (119). Preferably, the introducer may comprise a bevelled transition (136) between the first section (132) and second section (134). This bevelled transition (136) may be designed to provide a smooth sliding surface. Additionally, the second end (133) of the introducer (130) may be rounded, which may further reduce the risk of tissue trauma during insertion into the incision (119). This rounded end may allow for safer and more efficient handling of the introducer (133).

[0170] Hie introducer (130) may be made of a rigid material. Hie introducer (130) may be made out of a hard plastic or metal. The introducer (130) may have a smooth construction with a smooth / non-abrasive outer surface. There may be no grooves, holes or similar. Having a smooth surface can further help prevent damage to the inner surface (114) of the sleeve (120) or the hollow interior of the insert (114). Further, it may allow for reuse and easy sterilisation.

[0171] It can be appreciated that an introducer (130) may not be necessary as the sleeve (110) and insert (120) can be positioned and deployed manually by hand especially if a user prefers a tactile control. Alternatively, other tools such as clamps, forceps, or custom alignment aids may be used in place of an introducer (130) to guide the sleeve (110) and / or insert (120) into the incision (119). However, introducer (130) can still be useful and is most preferred and in some case even important, specifically in applications that demand extremely precise alignment and controlled insertion and placement of the sleeve (110) and / or insert (120) into the incision (119).

[0172] The present invention may also reside in a kit set or kit of parts comprising the sleeve (110) and tire insert (100) explained above. The introducer (130) may also be part of the kit.

[0173] A method of anchoring a sleeve (110) to biological tissue may involving multiple steps. The method may begin with providing a sleeve in a collapsed condition as shown in Figure 5A. where the sleeve (110). In this collapsed condition, the sleeve (110) may be inserted through an incision (119) and advanced into the biological tissue (in the direction of arrow A as shown in Figures 5A maintaining a low-profile design to minimise trauma and reduce the size of the incision required. Once inserted inside, the insert (120) may be inserted at least partially into the body (112) of the sleeve (110). The insert (110) may be inserted into the sleeve (130) through the introducer (130) to expand the sleeve. As shown in Figure 5B, the insert may be first received by the introducer (130) and caused to slide towards the direction of arrow B and C. Figure 5C shows the insert partially received within the body (112) of the sleeve (110) and Figure 5D shows the insert fully received within the body (112) of the sleeve. As it can be seen from Figures 5C and 5D, when at least partially or fully received within the body (110) of the sleeve (110), the sleeve transitions from its collapsed condition to an expanded condition, where the anchors extend outwardly to exert pressure on the surrounding biological tissue, securely anchoring the sleeve (110) in place.

[0174] Although, not shown in Figures 5A-5D, when inserting the sleeve (110) through the incision (119), the collapsed sleeve may be attached over an introducer (130), which can then be used to advance the sleeve (1 0) through the incision (110).

[0175] After the sleeve (110) is securely anchored, the method may comprise the removal of the introducer (130) by moving it towards the direction of arrows D and E.

[0176] In certain embodiments, both the introducer ( 130) and the insert ( 110) may be removed after anchoring is achieved, leaving only the sleeve (110) in place. However, it is most preferred that only introducer (130) is removed after anchoring is achieved, leaving the sleeve (110) in place with the insert (110) received into the body (112) of the sleeve (110) to maintain the anchoring.

[0177] Once the procedure is completed, the insert (120) may be removed from the sleeve (110). Tlris may cause the sleeve (110) to return to the collapsed condition facilitating its easy removal from the incision (110). lire components of the apparatus (100) may then be cleaned and sterilised for reuse. Aspects of the present invention have been described by way of example only and it should be appreciated that modifications and additions may be made thereto without departing from the scope thereof.

[0178] Figures 6-8 show an apparatus (200) according to another preferred embodiment of the present invention. The apparatus (200) of this example is similar in most aspects to the article (100) described above and the differences can be identified by comparing Figures 1 to 4 and 5A-5D with Figures 6-8, more particularly comparing Figure 5B with Figure 6.

[0179] In figures relating to the apparatus (200), the features that are similar to those shown in figures relating to apparatus (100) are identified with the same reference numeral, incremented by 100. Most of the description of the apparatus (100) of a preferred embodiment above, equally applies to the apparatus (100) and therefore need not be described again in too much detail. Mostly, only the main differences will be discussed.

[0180] Figure 7 is an end view of Figure 6. Figure 8 is a cross-sectional view' of Figure 6 along longitudinal axis A-A.

[0181] One main difference is in the sleeve (210) comprises a lid (225) located at the flange (211) of the sleeve (200). As already mentioned above, the embodiment of the sleeve (110) of Figure 1 may also have similar lid. Alternatively, the flange (221) of the insert (210) may have such a lid.

[0182] Other than the above-mentioned difference(s) and / or difference(s) that are obvious from the figures, all other features of the apparatus 200 including the features of the various components and methods of use may be same as that described above with reference to apparatus (100). One of more components of apparatus (100) namely sleeve (210), insert (220) and / or introducer (230) may be replaced with equivalent components namely, sleeve (110), insert (120) and introducer (130) respectively of this apparatus (200) and / or vice versa. The hollow interior (223) of the sleeve (210) is also shown in Figure 7, The sleeve (110) of previous embodiment described above may also have similar hollow interior as that of sleeve (210). Figures 9-11 show an apparatus according to another preferred embodiment of the present invention. More particularly. Figure 9 shows the sleeve (310) of this apparatus, Figure 10 show's the insert (320) ofthis apparatus, and Figure 11 shows an introducer (330) of this apparatus. The apparatus of this example is similar in most aspects to the article (100) described above and the differences can be identified by comparing Figures 1 to 4 and 5A-5D with Figures 9-11, more particularly comparing Figure 9 with Figure 1, Figure 10 with Figure 3 and Figure 11 with Figure 4. In figures relating to the apparatus of this embodiment, the features that are similar to those shown in figures relating to apparatus (100) are identified with the same reference numeral, incremented by 200. Most of the description of the apparatus (100) of a preferred embodiment above, equally applies to tlie apparatus of this example and therefore need not be described again in too much detail. Mostly, only the main differences will be discussed.

[0183] One main difference is in the shape of introducer (330) which has a flat first end (331 as compared to first end (131) of the apparatus (100) that is rounded.

[0184] Other difference main difference is positioning of the anchors (318) which are arranged on the body (312) in two separate groups. Also, the anchors (318) are only present in the region of the body that is proximal to the flange (311 ) and not throughout the body (312).

[0185] The insert (320) does not have bevelled or tapered edges.

[0186] Other than the above-mentioned difference(s) and / or difference(s) that are obvious from the figures, all other features of the apparatus ofthis embodiment including the features of the various components and methods of use may be same as that described above with reference to apparatus (100). One or more components of apparatus (100) such as sleeve (110), insert (120) and / or introducer (130) may be replaced with components of this apparatus namely, sleeve (310), insert (320) and introducer (330) respectively and / or vice versa. Similarly, the one or more components of apparatus (200) namely sleeve (210), insert (220) and / or introducer (230) may be replaced with equivalent components namely, sleeve (310), insert (320) and introducer (330) respectively of this apparatus and / or vice versa. ADVANTAGES

[0187] The present invention can reduce tissue damage through the use of blunt anchors and a smooth sleeve surface, allowing insertion through smaller skin incisions, thereby minimising trauma, reducing scarring, and accelerating healing. It may provide a secure anchoring mechanism through expandable anchors / wings that exert pressure on surrounding tissue to prevent dislodgement. The invention can eliminate the need for sutures, simplifying procedures and reducing time and complexity. The smooth, groove- free outer surface of the sleeve can allow easy sterilisation for reuse, offering a cost- effective and environmentally friendly solution. The invention can be applied in various clinical applications, such as but not limited to liposuction, laparoscopic surgery, chest tube anchoring, and surgical drainage. The collapsed anchors can reduce friction during insertion, allowing for atraumatic placement, while the anchoring mechanism may provide secure fixation at both skin and subcutaneous levels. The introducer can ensure precise alignment of the sleeve, and the ergonomic design may facilitate handling during deployment. Due to the ability to be easily sterilised the sleeve and / or insert can minimise the risk of infection.

[0188] Therefore, some of the non -limiting advantages of the present invention may include:

[0189] • Enabling smaller skin incisions to minimise tissue trauma and scarring.

[0190] ® Providing a secure anchoring mechanism without the need for sutures.

[0191] • Easily sterilisable surface for reuse, cost efficiency and reducing infection risks

[0192] ® Can be used for multiple purposes such as but not limited to liposuction, laparoscopic procedures, chest tube anchoring, and surgical drainage.

[0193] ® Reducing friction during insertion for atraumatic deployment.

[0194] ® Precise alignment and simplified handling with the use of introducer. « Quick and efficient deployment and anchoring

[0195] « Absence of threaded and sutured protectors for eliminating or significantly reducing risk of damage to the skin edges and subcutaneous tissues.

[0196] ® Avoiding the use of surgical sutures and reducing operative time, thereby minimising procedural costs

[0197] • Reducing scar widening and hyperpigmentation, particularly in darker-skinned patients, thereby improving long-term outcomes.

[0198] • Providing a faster, more efficient alternative for securing drainage and surgical tubes without additional hardware or complex techniques.

Claims

CLAIMS1. An apparatus for anchoring to biological tissue, the apparatus comprising:a sleeve that is configured to transition between a collapsed condition and an expanded condition, the sleeve comprising a flexible body having an inner surface and an outer surface, and a plurality of anchors integrally formed on the outer surface of the body; andan insert that is configured to be at least partially inserted into the body of the sleeve to transition the sleeve from the collapsed condition to the expanded condition, wherein when in the collapsed condition the sleeve is configured for insertion through an incision and when in the expanded condition at least the plurality of anchors extends outwardly to exert pressure on surrounding tissue that is the biological tissue thereby anchoring the sleeve securely in place.

2. An apparatus of claim 1, wherein the sleeve is made of an elastomeric material, a metal, or a percaline.

3. An apparatus as claimed in claim 1, wherein the sleeve is made of a silicone material.

4. An apparatus as claimed in any one of the preceding claims, wherein the plurality of anchors is made out of same material as the body.

5. An apparatus as claimed in any one of the preceding claims, wherein a rigidity of the plurality of anchors is same as a rigidity' of the body.

6. An apparatus as claimed in any one of claims 1 to 4, wherein a rigidity' of the plurality of anchors is less than a rigidity' of the body.

7. An apparatus as claimed in any one of claims 1 to 6, the inner and outer surface are smooth or non-abrasive.

8. An apparatus as claimed in any one of claims 1 to 7, wherein the sleeve has no grooves and / or holes at the body and the plurality of anchors.

9. An apparatus as claimed in any one of the preceding claims, wherein the plurality of anchors is arranged the outer surface of the body to expand to a plurality of directions when in the expanded condition.

10. An apparatus as claimed in any one of the preceding claims, wherein the plurality of anchors comprises at least two flexible anchors.

11. An apparatus as claimed in any one of the preceding claims 1 to 11, wherein the plurality of anchors comprises at least four flexible anchors.

12. An apparatus as claimed in any one of the preceding claims, wherein each of the plurality of anchors is spaced apart from one another.

13. An apparatus as claimed in any one of the preceding claims, wherein each of the plurality of anchors has one or more blunt edges or rounded corners for preventing tissue damage.

14. An apparatus as claim ed m any one of the preceding claim s, wherein the body of the sleeve has rounded comers.

15. An apparatus as claimed in any one of the preceding claims, wherein each of the plurality of anchors is of or substan tially aerofoil shape.

16. An apparatus as claimed in any one of the preceding claims, wherein the plurali ty of anchors is in the form of a plurality of wings.

17. An apparatus as claimed in any one of the preceding claims, wherein the plurality of anchors is arranged symmetrically around the body.

18. An apparatus as claimed in any one of the preceding claims, wherein the plurality of anchors is arranged symmetrically around the body in multiple directions.

19. An apparatus as claimed m any one of the preceding claims, wherein the plurality of anchors is arranged symmetrically around the body in at least four columns.

20. An apparatus as claimed in any one of the preceding claims, wherein the plurality of anchors is arranged symmetrically around the body in at least four directions, 21, An apparatus as claimed in any one of the preceding claims, wherein hollow cylindrical structure for receiving the insert when the insert is inserted into the body.

22. An apparatus as claimed in any one of the preceding claims, wherein the body is configured to flex to conform to the contours of surrounding tissue when in use.

23. An apparatus as claimed in any one of the preceding claims, wherein the sleeve or the body of the sleeve is of a flexible structure that is configured to take shape and rigidity upon insertion of the insert.

24. An apparatus as claimed in any one of the preceding claims, wherein the sleeve or the body of the sleeve is made of a flexible material that is configured to adopt a predefined shape upon insertion of the insert, transitioning from the collapsed condition where the sleeve of the body of the sleeve is in a substantially flattened configuration to the expanded condition where the sleeve or the body of the sleeve is in a substantially tubular, expanded configuration with the plurality of anchors deployed outwardly for anchoring.

25. An apparatus as claimed in any one of the preceding claims, wherein the insert is shaped to progressively expand the plurality of anchors as the sleeve slides through the sleeve when inserted into the body of the sleeve.

26. An apparatus as claimed in any one of the preceding claims, wherein the plurality of anchors is configured to be and remain flush or substantially flush with the outer surface of the body in the collapsed condition to minimise the dimension for insertion through the incision.

27. An apparatus as claimed in any one of tire preceding claims, wherein in the collapsed condition, plurality of anchors is configured to minimise friction during insertion through the skin incision.

28. An apparatus as claimed m any one of the preceding claims, wherein the body comprises a tapered tip or tip with bevelled edges.

29. An apparatus as claimed in any one of the preceding claims, wherein the anchors are made of a flexible, shape memory material that transitions to the expanded condition upon release.

30. An apparatus as claimed in any one of the preceding claims, wherein when in the expanded condition, each of the plurality of anchors is configured to extend at an angle between substantially 70 degrees to substantially 90 degrees from the body.

31. An apparatus as claimed in any one of claims 1 to 29, wherein when in the expanded condition, each of the plurality of anchors is configured to extend at substantially 90 degrees from the body.

32. An apparatus as claimed in any one of the preceding claims, wherein in the collapsed condition, the body and the plurality of anchors is configured to collectively form a reduced profile for allowing insertion of the body and the plurality’ of anchors through the incision that is smaller than cross-sectional dimensions of the body and the plurality anchors in the expanded condition.

33. An apparatus as claimed in any one of the claims 1 to 31, wherein the body is configured to extend longitudinally along a longitudinal axis and maximum cross- sectional dimension of the body and the plurality of anchors measured orthogonal to the longitudinal axis of the body and anchors in the collapsed condition is smaller than the maximum cross-sectional dimensions of the body and anchors in the expanded condition.

34. An apparatus as claimed m any one of the preceding claims, wherein the plurality of anchors is configured to anchor into subcutaneous tissue, the subcutaneous tissue bemg the bioiogical tissue.

35. An apparatus as claimed in any one of the preceding claims, wherein, the insert is made of a rigid material.

36. An apparatus as claimed in any one of the preceding claims, wherein the insert is made of a material having the rigidity or hardness that is sufficient to provide consistent force to allow the sleeve to transition from the collapsed condition to the expanded condition.

37. An apparatus as claimed in any one of the preceding claims, wherein the insert is made out of a hard plastic or a metal.

38. An apparatus as claimed in any one of the preceding claims, wherein at least a portion of the insert is tapered to allow' gradual expansion of the body and anchors as the insert is advanced within the body.

39. An apparatus as claimed in any one of the preceding claims, wherein the insert has a rigid construction with a smooth or non-abrasive outer surface.

40. An apparatus as claimed in any one of the preceding claims, wherein the insert comprises a cylindrical structure with a hollow interior for guiding and aligning the sleeve during deployment.

41. An apparatus as claimed in any one of the preceding claims, wherein the insert has smooth or non-abrasive edges to minimise friction during insertion into the sleeve.

42. An apparatus as claimed in any one of the preceding claims, wherein the insert has one or more rounded comers for preventing damage to the tissue or the sleeve.

43. An apparatus as claimed in any one of the preceding claims, wherein the insert comprises a gripping surface or texture on its flange.

44. An apparatus as claimed m claim 40, wherein the hollow interior of the insert is dimensioned or configured to allow drainage tube(s), cannula(s) and / or surgical instruments to be inserted within the hollow interior.

45. An apparatus as claimed in any one of the preceding claims, wherein the insert and / or sleeve is made out of a reusable material.

46. An apparatus as claimed in any one of the preceding claims, wherein the sleeve comprises a flange at its base that is configured to abut to outside of the skin of the patient when m use, thereby preventing over-insertion of the sleeve inside the skin incision.

47. An apparatus as claimed in any one of the preceding claims, wherein the insert comprises a flange, at its base for preventing over-insertion into the sleeve.

48. An apparatus as claimed in claims 46 or 47, wherein the flange of the sleeve comprises at least one first engagement member, and the flange of the insert comprises at least one second engagement member, wherein the first engagement member and the second engagement member are configured to engage with each other to lock, preferably temporarily lock, the insert within the sleeve when the insert is inserted into the body of the sleeve.

49. An apparatus as claimed in any one of the preceding claims, wherein the flange of the insert comprises engagement means for attachment to an external device.

50. An apparatus as claimed in any one of the preceding claims, wherein the cylindrical structure of the insert comprises a tapered region at or near an end that is distal from the flange of the insert.

51. An apparatus as claimed in any one of the preceding claims, wherein the insert comprises a lid that is a removable or detachable, wherein the lid when in closed configuration is configured to conceal the hollow' interior of the insert at its end that is proximal to the incision when in use and / or proximal to the flange of the insert.

52. An apparatus as claimed in any one of the preceding claims, wherein the sieeve comprises a lid that is a removable or detachable, wherein the lid when in closed configuration is configured to conceal the hollow interior of the insert or interior of the body of the sleeve at its end that is located proximal to the incision when in use, proximal to the flange of the insert and / or proximal to the flange of the sleeve.

53. An apparatus as claimed in any one claim 51 or 52, wherein the lid is hingedly mounted to the flange of the insert or to the flange of the sleeve,54. An apparatus as claimed in any one of the preceding claims, wherein the apparatus further comprises an introducer for insertion and alignment of the sleeve and / or the insert into the incision when in use, the introducer comprising:an elongated cylindrical body extending longitudinally from a first end to a second end that is opposite the first end;a first section extending longitudinally from the first end towards the second end, the first end suitable for providing grip and control of manual manipulation when the introducer is in use;a second section extending longitudinally from the first section towards the second end, the second section suitable for guiding the sleeve and / or insert during insertion; andwherein, the diameter of the first section is larger than the diameter or the second section, aspect55. An apparatus as claimed in claim 54, wherein the introducer comprises a bevelled transition between the first and second sections.

56. An apparatus as claimed in claim 55, wherein at least the second end of the introducer is rounded.

57. A sleeve of an apparatus as claimed in any one of claims 1 to 56, for use in anchoring to a biological tissue, the sleeve comprising:a flexible body comprising a plurality of anchors integrally formed on an outer surface of the body, wherein the sleeve is configured to transition between the collapsed condition and the expanded condition wherein in the collapsed condition sleeve is configured for insertion through an incision and wherein in the expanded condition, at least the plurality of anchors extend outwardly to exert pressure on surrounding tissue that is the biological tissue thereby anchoring the sleeve securely in place.

58. An insert of an apparatus as claimed in any one of claims 1 to 56, wherein the insert is configured to be used with a sleeve, the sleeve being an expandable sleeve that is configured to transition between a collapsed condition and an expanded condition, the sleeve comprising a flexible body having an inner surface and an outer surface with a. plurality of anchors integrally formed on the outer surface of the body, wherein the insert is configured to be at least partially inserted into the body of the sleeve to transition the sleeve from the collapsed condition to the expanded condition, wherein when in the collapsed condition the sleeve is configured for insertion through an incision and when in the expanded condition at least the plurality of anchors extend outwardly to exert pressure on surrounding tissue that is the biological tissue thereby anchoring the sleeve securely m place.

59. An introducer of or configured to be used with an apparatus as claimed in any one of claims 1 to 56, wherein for insertion and alignment of a sleeve and / or an insert into the incision when in use, the introducer comprising:an elongated cylindrical body extending longitudinally from a first end to a second end that is opposite the first end;a first section extending longitudinally from the first end towards the second end, the first end suitable for providing grip and control of manual manipulation when the introducer is in use;a second section extending longitudinally from the first section towards the second end, the second section suitable for guiding the sleeve and / or the insert during insertion; andwherein, the diameter of the first section is larger than the diameter of the second section.60, A kit set for an apparatus of any one of claims 1 to 56, the kit set comprising: a sleeve that is configured, m use, to transition between a collapsed condition and an expanded condition, the sleeve comprising a flexible body having an inner surface and an outer surface with a plurality of anchors integrally formed on the outer surface of the body; andan insert that is configured, in use, to be at least partially inserted into the body of the sleeve to transition the sleeve from the collapsed condition to the expanded condition, wherein when in the collapsed condition the sleeve is configured for insertion through an incision and when in the expanded condition at least the plurality of anchors extend outwardly to exert pressure on surrounding tissue that is the biological tissue thereby anchoring the sleeve securely in place.

61. A kit set as claimed in claim 60, wherein the kitset further comprises an introducer for insertion and alignment of the sleeve and / or insert into the incision when in use, the introducer comprising: an elongated cylindrical body extending longitudinally from a first end to a second end that is opposite the first end; a first section extending longitudinally from the first end towards the second end, the first end suitable for providing grip and control of manual manipulation when the introducer is in use; a second section extending longitudinally from the first section towards the second end, the second section suitable for guiding the sleeve and / or the insert during insertion; and wherein, the diameter of the first section is larger than the diameter or the second section.

62. A method of anchoring a sleeve to biological tissue, the method comprising: providing a sleeve in a collapsed condition, the sleeve comprising a flexible body with a plurality of anchors integrally formed on an outer surface of the body;inserting the sleeve in the collapsed condition through an incision into the biological tissue;inserting an insert at least partially into the body of the sleeve thereby transitioning the sleeve to an expanded condition with the plurality’ of anchors extending outwardly to exert pressure on the surrounding biological tissue, thereby anchoring the sleeve securely in place.

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