A knotless suture device

Abstract

Embodiments of the present disclosure relate to a knotless suture device. The knotless suture device includes a first suture holder (102) configured to operably grip a far end (114a) of a suture material (114) and a second suture holder (104) configured to receive and operably grip a near end (114b) of the suture material (114). Further, the first suture holder (102) and the second suture holder (104) may be two different components of the knotless suture device or may be aligned as a single component. Furthermore, the suture material (114) may be moveable bidirectionally through the first suture holder (102) and / or the second suture holder (104), until the suture material (114) is gripped by the first suture holder (102) and / or the second suture holder (104), respectively, using a corresponding gripping assembly.

Description

A KNOTLESS SUTURE DEVICETECHNICAL FIELD

[0001] The present disclosure generally relates to the field of medical devices. In particular, the present disclosure relates to knotless / knot-free suture devices.BACKGROUND

[0002] As conventionally known in the art, the suturing techniques generally involve manually tying knots using suture materials to secure the wound closure. While effective, these methods have several disadvantages.

[0003] Existing suturing solutions require the suture material to be tied in a knot. Knots in traditional sutures can create uneven tension along the wound, leading to tissue irritation, delayed healing, prolonged and increased pain & discomfort, increased scarring, and potential complications like infection, as the knots can trap bacteria.

[0004] Additionally, the process of tying knots is time-consuming and requires significant skill, which can prolong surgery and increase the likelihood of operator-dependent variability in the outcome. In confined or minimally invasive surgical settings, knot tying can be particularly challenging, further complicating the procedure, prolonging the suture placement, and increasing risk associated with procedure.

[0005] In contrast, knotless suturing eliminates these issues by providing uniform tension across the wound, reducing tissue irritation, and scarring, and lowering the risk of infection. The knotless approach also streamlines the surgical process, making it faster and more efficient while offering more consistent results regardless of the surgeon’s skill level.

[0006] However, existing knotless suture solutions use barbed sutures. Barbed sutures have restricted indications of use and safety issues associated with barbed edges, which have the potential to cause further abrasions / cuts during suture placement and removal thereof. The barbed edges may also pierce through otherwise healthy tissues, and cause discomfort to the patient. Further, barbed sutures are prohibitively expensive to manufacture have not gained traction in the market, a final vindication of their limitations. Also, current first aid options for fresh wound or injuries that need sutures are highly demanding and complicated in terms of self-application or for non- professional help. Furthermore, personnel from the armed forces, who are more susceptible to severe injuries, lack a field-friendly, "Do It Yourself suturing solution that is both simple and easy to use.

[0007] Therefore, there is a long pending need for an improved knotless suture device having minimal risk of infection and optimum suture closure characteristics, so that the healing time is reduced and healing efficacy is improved with minimal scarring.OBJECTS OF THE PRESENT DISCLOSURE

[0008] A general object of the present disclosure is to provide an efficient and improved knotless suture device that obviates the above-mentioned limitations of existing systems / devices.

[0009] Another object of the present disclosure is to provide a knotless suture device that facilitates optimum suture closure characteristics with reduced healing time.

[0010] Yet another object of the present disclosure is to provide a knotless suture device that uses suture holders to grip / hold the sutures, thereby reducing complications, reducing scarring, enhancing surgical efficiency, simplifying technique, ensuring consistency and reliability, minimizing operator dependency, reducing cost of surgery.SUMMARY

[0011] Aspects of the present disclosure generally relate to the field of medical devices. In particular, the present disclosure relates to knotless / knot-free suture devices.

[0012] In an aspect of the present disclosure, a knotless suture device includes a first suture holder configured to operably grip a far end of a suture material and a second suture holder configured to receive and operably grip a near end of the suture material.

[0013] In another aspect, the first suture holder and the second suture holder may be two different components of the knotless suture device or may be aligned as a single component.

[0014] In an aspect, the suture material may be moveable bidirectionally through the first suture holder and / or the second suture holder, until the suture material is gripped by the first suture holder and / or the second suture holder, respectively, using a corresponding gripping assembly.

[0015] In another aspect, the suture material may be moveable unidirectionally through the first suture holder and / or the second suture holder.

[0016] In a further aspect, the suture material may be moveable unidirectionally through the second suture holder, and bidirectionally through the first suture holder, until the far end of the suture material is gripped by the first suture holder using a first gripping assembly.

[0017] In another aspect, the suture material may be moveable unidirectionally through the first suture holder, and bidirectionally through the second suture holder, until the suture material is gripped by the second suture holder using a second gripping assembly.

[0018] In another aspect, the knotless suture device includes an interlinking element attached to the first suture holder and / or the second suture holder through a corresponding set of lock pins. The interlinking element may be configured to operably shift from a neutral position to a locking position with respect to the first suture holder and / or the second suture holder.

[0019] In an aspect, in the neutral position, the corresponding set of lock pins may separate the interlinking element from the first suture holder and / or the second suture holder by a predetermined distance, while in the locking position, an inner surface of the first suture holder and / or the second suture holder may be in engagement with an interior surface of the interlinking element, such that the corresponding set of lock pins may secure the engagement between the interlinking element and the first suture holder and / or the second suture holder.

[0020] In another aspect, the knotless suturing device may also include a corrugated (i.e., any shape not limited to flat, cylindrical, triangular, square, rectangular, and the like) suture material and a suture holder attached to a far end of the suture material. The suture material may further include a sharp end or a needle that may be moveable unidirectionally through the suture holder.

[0021] In another aspect, the knotless suture device may include grip facilitators for first and / or second suture holders, which may involve any mechanical grip facilitator option for holding a plain or corrugated suture material to replace necessity for knot in suturing.

[0022] Various objects, features, aspects, and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The accompanying drawings are included to provide a further understanding of the present disclosure, and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

[0024] FIGs. 1A-1C illustrate a schematic front view, top view, and isometric view of a first knotless suture device having a first suture holder and a second suture holder which are both bidirectional, in accordance with an embodiment of the present disclosure.

[0025] FIGs. 1D-1F illustrate a schematic representation of the first knotless suture device being used for suturing, in accordance with an embodiment of the present disclosure.

[0026] FIGs. 2A-2C illustrate a schematic front view, top view, and isometric view of a second knotless suture device having one unidirectional suture holder and one bidirectional suture holder, in accordance with an embodiment of the present disclosure.

[0027] FIGs. 2D-2F illustrate a schematic representation of the second knotless suture device being used for suturing, in accordance with an embodiment of the present disclosure.

[0028] FIG. 3A illustrates a schematic representation of a third knotless suture device being used for suturing, where the first suture holder is bidirectional and the second suture holder is unidirectional, in accordance with an embodiment of the present disclosure.

[0029] FIG. 3B illustrates a schematic representation of a fourth knotless suture device being used for suturing, where both the first suture holder and the second suture holder are unidirectional, in accordance with an embodiment of the present disclosure.

[0030] FIGs. 4A-4C illustrate a schematic front view, isometric view, and exploded view of a fifth knotless suture device having an interlinking element, in accordance with an embodiment of the present disclosure.

[0031] FIGs. 4D-4F illustrate a schematic representation of the fifth knotless suture device being used for suturing, in accordance with an embodiment of the present disclosure.

[0032] FIGs. 5A-5B illustrate a schematic front view, and an isometric view of a sixth knotless suture device having a cylindrical locking mechanism, in accordance with an embodiment of the present disclosure.

[0033] FIGs. 5C-5E illustrate a schematic representation of the sixth knotless suture device being used for suturing, in accordance with an embodiment of the present disclosure.

[0034] FIG. 6A illustrates a schematic view of a seventh knotless suture device, in accordance with an embodiment of the present disclosure.

[0035] FIG. 6B illustrates a schematic representation of the seventh knotless suture device being used for suturing, in accordance with an embodiment of the present disclosure.DETAILED DESCRIPTION

[0036] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the present disclosure as defined by the appended claims.

[0037] For the purpose of understanding the principles of the present disclosure, reference will now be made to the various embodiments and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the present disclosure is thereby intended, such alterations and further modifications in the illustrated system, and such further applications of the principles of the present disclosure as illustrated therein being contemplated as would normally occur to one skilled in the art to which the present disclosure relates.

[0038] It will be understood by those skilled in the art that the foregoing general description and the following detailed description are explanatory of the present disclosure and are not intended to be restrictive thereof.

[0039] Whether or not a certain feature or element was limited to being used only once, it may still be referred to as “one or more features” or “one or more elements” or “at least one feature” or “at least one element.” Furthermore, the use of the terms “one or more” or “at least one” feature or element does not preclude there being none of that feature or element, unless otherwise specified by limiting language including, but not limited to, “there needs to be one or more” or “one or more elements is required.”

[0040] Reference is made herein to some “embodiments.” It should be understood that an embodiment is an example of a possible implementation of any features and / or elements of the present disclosure. Some embodiments have been described for the purpose of explaining one or more of the potential ways in which the specific features and / or elements of the proposed disclosure fulfil the requirements of uniqueness, utility, and non-obviousness.

[0041] Use of the phrases and / or terms including, but not limited to, “a first embodiment,” “a further embodiment,” “an alternate embodiment,” “one embodiment,” “an embodiment,” “multiple embodiments,” “some embodiments,” “other embodiments,” “further embodiment”, “furthermore embodiment,” “additional embodiment” or other variants thereof do not necessarily refer to the same embodiments. Unless otherwise specified, one or more particular features and / or elements described in connection with one ormore embodiments may be found in one embodiment, or may be found in more than one embodiment, or may be found in all embodiments, or may be found in no embodiments. Although one or more features and / or elements may be described herein in the context of only a single embodiment, or in the context of more than one embodiment, or in the context of all embodiments, the features and / or elements may instead be provided separately or in any appropriate combination or not at all. Conversely, any features and / or elements described in the context of separate embodiments may alternatively be realized as existing together in the context of a single embodiment.

[0042] Any particular and all details set forth herein are used in the context of some embodiments and therefore should not necessarily be taken as limiting factors to the proposed disclosure.

[0043] The terms “comprise,” “comprising,” or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such process or method. Similarly, one or more devices or sub-systems or elements or structures or components proceeded by “comprises... a” does not, without more constraints, preclude the existence of other devices or other sub-systems or other elements or other structures or other components or additional devices or additional sub-systems or additional elements or additional structures or additional components.

[0044] In an embodiment, the present disclosure largely relates to the field of medical devices. In particular, the present disclosure relates to knotless / knot-free suture devices. Various embodiments of the present disclosure are described in detail in reference to FIGs. 1A to 6B.

[0045] Referring to FIGs. 1A-1C, schematic front view, top view, and isometric view of a first knotless suture device 100 having a first suture holder 102 and a second suture holder 104 are illustrated, respectively, in accordance with an embodiment of the present disclosure.

[0046] In some embodiments, the first and the second suture holders 102, 104 may include a housing 110 configured to receive and secure a cap 106 thereinto. In some embodiments, the first and the second suture holders 102, 104 may have a substantially cylindrical contour, however, the geometry and dimensions of the first and the second suture holders 102, 104 may be suitably modified based on requirements and / or constraints of the use case. In some embodiments, the first suture holder 102 and the second suture holder 104 may be the two different components of the knotless suture device 100. In otherembodiments, the first suture holder 102 and the second suture holder 104 may be attached together using a bridge 108 as a single component.

[0047] In an embodiment, the first suture holder 102 may be configured to operably grip a far end 114a of a suture material 114 (as shown in FIGs. ID to IF), and the second suture holder 104 is configured to receive and operably grip a near end 114b of the suture material 114. In some embodiments, the suture material 114 may be any one or a combination of natural sutures, synthetic absorbable sutures, synthetic non-absorbable sutures, and metal sutures, but not limited thereto. The suture material 114 may include a pointed end or a needle configured to bite / pierce / penetrate into tissues 116 (as shown in subsequent figures of the present disclosure). In some embodiments, the suture material 114 may have a geometric profile of a strand / filament / thread. In other embodiments, the suture material 114 may include a corrugated profile, as described subsequently in the present disclosure. Tensile strength, length, diameter / thickness, materials, and other properties of the suture materials 114 may be determined based on the requirements and / or constraints of the use case.

[0048] In some embodiments, the first and the second suture holders 102, 104 may include an orifice to allow the suture materials 114 to be passed / pushed / pulled therethrough. In some embodiments, the suture material 114 may be moveable bidirectionally through the first suture holder 102 and / or the second suture holder 104 (or the orifices thereof), until the suture material 114 is gripped by the first suture holder 102 and / or the second suture holder 104, respectively, using a corresponding gripping assembly. The gripping assembly may be any fastening means, such as interlocking elements, slide locking elements, rivets, press locking buttons, friction gripping means, and the like, but is not limited thereto.

[0049] In another embodiment, the first suture holder 102 and / or the second suture holder 104 may operably grip the suture material 114 using a corresponding gripping assembly that may further include a friction gripping means.

[0050] In some embodiments, the friction gripping means may include a set of protrusions 112 within the housing 110 arranged to form an orifice configured to allow the suture material 114 to be passed therethrough. In such embodiments, the orifice may have a diameter larger than that of the suture material 114. The set of protrusions 112 facilitates a ratchet grip either alone or with assistance from the cap 106, where the configurations can be altered accordingly. The first and the second suture holders 102, 104 may also include the cap 106 having a set of inclined surfaces and in a neutral position to link or assemble both the cap 106 and the suture holders 102 and / or 104. The inclined surfaces may be configured to abut the set of protrusions 112 when the cap 106 is slid / pushed into the housing 110. A surgeon ora user may press the cap 106 into the housing 110 to lock the position of the suture material 114 with respect to suture holders 102, 104. The abutting of the set of protrusions 112 causes the orifice to contract (i.e., reduce in diameter) and grip the suture material 114. Hence, when implementing the friction gripping means, the suture holders 102, 104 of the first knotless suture device 100 may allow the suture material 114 material to be pushed bidirectionally therethrough, as well as allow the suture material 114 to be operably locked. The locking of the suture material on the first and the second suture holders 102, 104 may enable the surgeon / user to suture tissues (such as tissues 116 shown in FIGs. ID to IF) or ligate tubular structures as needed. For example, tissues separated due to wounds, punctures, or incisions made during surgery, may be closed or ligatures to be placed on tubular structures like blood vessels, vas deferens, or the like, using the suture material 114, which may be secured without requiring knots using the (first) knotless suture device 100.

[0051] Further referring to FIGs. ID- IF, a schematic representation of the first knotless suture device 100 being used for suturing is depicted, in accordance with an embodiment of the present disclosure. As shown, for suturing the tissue 116, the first knotless suture device 100 may be used to secure the suture material 114, after the suture material 114 has been pierced through the tissue 116.

[0052] In some embodiments, the suture material 114 may include a second / distal / far end 114a and a first / proximal / near end 114b. In some embodiments, the near end 114b may include a pointed end or a needle configured to pierce through the tissue 116. The near end 114b may be pushed / passed / drawn through the first suture holder 102, as shown in FIG. ID. The suture material 114 may pass through the orifice formed between the protrusions 112, and a corresponding hole on the cap 106. Then, the cap 106 of first suture holder 102 is pressed to engage the lock to hold far end 114a of the suture material 114, thereby freeing the hand of the surgeon / user. The suture material 114 may then bite / penetrate into and through the tissue 116 using the near end 114b, as shown in FIG. IE. The suture material 114 may be bit into or pierced through the tissue 116 to form any desired suture pattern or ligation structure. Further, the near end 114b may be passed through or pushed through the second suture holder 104, for example through the orifice / hole thereof, as shown in FIG. IE. Since the first suture holder 102 and the second suture holder 104 may allow the suture material 114 to be moved bidirectionally therethrough, the surgeon / user may pull the suture material 114 in either direction with respect to the first and / or the second suture holders 102, 104, before the first and / or the second suture holders 102, 104 are locked. The bidirectional passage may enable the surgeon / user to pull the suture material 114 up to a desired length.Once the first suture holder 102 is locked, pulling on the suture material may enable the surgeon / user to achieve a desired tension or alignment. Further, the locking / gripping operation of the first suture holder 102 may free the hand of the surgeon, and enable them to use their hands or other tools (such as forceps) conveniently to pierce the suture material 114 through the tissue 116, passing the near end 114b through the second suture holder 104, and pulling the suture material 114 by the near end 114b provide the desired tension and alignment of the suture material 114.

[0053] Thereafter, the suture material 114 may be locked by pressing the cap 106 into the housing 110 of the second suture holder 104, as shown in FIG. IF. To summarize, the sequence is first the cap 106 is pressed on the first suture holder 102 with the near end 114b in position and take bite into tissues, pass the near end 114b through the second suture holder 104, press the cap 106 of the second suture holder 104 into the locked position after creating required apposition / alignment strength or reverse of the same starting with the second suture holder 104 then to the first suture holder 102. This process effectively eliminates the need for traditional knot-tying in the suturing procedure and reduces the risk of suture loosening or unravelling. The first knotless suture device 100 may further ensure the tension on the suture material 114 is consistent, and does not change during the healing process. The design of the first knotless suture device 100 ensures consistent and secure placement of the suture material, enhancing surgical efficiency and reliability. Such knotless suture device 100 is particularly beneficial in delicate procedures where precision and control are essential, as well as in minimally invasive surgeries where limited space complicates traditional suture methods.

[0054] While the aforementioned embodiments describe a knotless suture device 100 having two suture holders 102, 104 allowing bidirectional movement of the suture material 114 therethrough, in other embodiments, at least one of the suture holders 102, 104 may be unidirectional, as described in the forthcoming description.

[0055] Referring to FIGs. 2A-2C, a schematic front view, top view, and isometric view of a second knotless suture device 200 with one unidirectional suture holder (such as first suture holder 202) and one bidirectional suture holder (such as second suture holder 204), are illustrated, respectively, in accordance with an embodiment of the present disclosure.

[0056] In such embodiments, the suture material 114 may be moveable unidirectionally through the first suture holder 202. In some embodiments, the suture material 114 may include a linear ratchet rack (which provides the suture material 114 with a corrugated geometric profile), and the first suture holder 202 may include a pawl 214. The pawl 214 maybe configured to abut against the linear ratchet rack when the suture material 114 is moved / pushed in a first direction through the first suture holder 202, and slide over the linear ratchet rack when the suture material 114 is moved in a second direction through the first suture holder 202. The abutting of the pawl 214 against the linear ratchet rack may only allow unidirectional movement of the suture material 114 through the first suture holder 202. With respect to FIGs. 2D to 2F, the first direction may correspond to a direction towards the tissue 116 and the second direction may correspond to a direction opposite to the first direction.

[0057] Furthermore, the suture material 114 may be moveable bidirectionally through the second suture holder 204 (which may be implemented similarly to the second suture holder 104), until the suture material 114 is gripped / locked by the second suture holder 204 using the corresponding gripping assembly therein. In some embodiments, the gripping assembly may include a cap 206, which may be moved into a housing of the second suture holder 204 to lock the suture material 114 therein. In some embodiments, the first suture holder 202 and the second suture holder 204 may be integrally attached using a bridge 208.

[0058] FIGs. 2D-2F illustrate a schematic representation of the second knotless suture device 200 being used for suturing, in accordance with an embodiment of the present disclosure. As shown, the near end 114b of the suture material 114 may be inserted through the unidirectional first suture holder 202, which prevents backward slippage, as shown in FIG. 2D. The far end 114a is pushed in minimally to lock the grip at the first suture holder 202. The suture material 114 is then pierced through the tissue 116. Following this, the suture material 114 may be inserted through the second suture holder 204, as shown in FIG. 2E. The surgeon / user may then pull the suture material 114 through the second suture holder 204. Once the desired tension is achieved, the second holder 204 may be brought to the locked position by pressing its cap 206, as depicted in FIG. 2F, thereby ensuring a secure and precise closure of the tissue 116 without requiring knots.

[0059] Referring to FIG. 3A, a schematic representation of a third knotless suture device 300a is shown, in accordance with an embodiment of the present disclosure. As shown, the third knotless suture device 300a may include a first suture holder 302 which may allow the suture material 114 to be passed bidirectionally therethrough until the far end 114a of the suture material 114 is operably gripped by the first suture holder 302 using the corresponding gripping assembly, and a second suture holder 304 which may allow the suture material 114 to be moved unidirectionally therethrough. In such embodiments, the suture material 114 may be inserted through the bidirectional first suture holder 302, allowing movement in both directions for initial adjustments. Then, the far end 114a may be locked / gripped at the firstsuture holder 302 once the desired length of the suture material 114 has been pulled therethrough, whereafter a cap of the first suture holder 302 may be pressed into a housing thereof. By pressing the cap, the suture material 114 is locked securely in place, ensuring a firm closure without the need for knots. Subsequently, the near end 114b of the suture material 114 may be pierced through the tissue 116, and then inserted through the unidirectional second suture holder 304, where backward movement is restricted, thereby preventing slippages when the near end 114b of the suture material 114 is pulled therethrough.

[0060] Similar to the second knotless suture device 200, the third knotless suture device 300a maintains the efficiency of knotless closure with the added advantage of allowing initial bidirectional adjustments through the first suture holder 302. However, in the third knotless suture device 300a, the first direction corresponds to the movement against / opposite the tissue 116 through the second suture holder 304, and the second direction corresponds to the direction towards the tissue 116 where movement is restricted to prevent reversal, unlike in the second knotless suture device 200.

[0061] Now, referring to FIG. 3B, a schematic representation of a fourth knotless suture device 300b is shown, in accordance with an embodiment of the present disclosure. As shown, the fourth knotless suture device 300b may include a first suture holder 306 and a second suture holder 304, where both suture holders 306, 304 allow unidirectional passage or movement of the suture material 114 therethrough. In the fourth knotless suture device 300b, the suture material 114 may be initially inserted through the unidirectional first suture holder 306, then pierced through the tissue 116, and subsequently passed / threaded through the unidirectional second suture holder 304. The unidirectional nature of both suture holders 306, 304 may prevent any backward movement, ensuring the suture material 114 remains securely in place. Thereafter, the suture material 114 may be pulled, while holding at least one of the first or second suture holders 306, 304, thereby reducing the length of the suture material 114 between the suture holders 306, 304 to create the desired tension or compression to effectively hold the tissue 116, without requiring knots.

[0062] Referring to FIGs. 4A-4C, a schematic front view, isometric view, and exploded view of a fifth knotless suture device 400 having an interlinking element 408 are depicted, in accordance with an embodiment of the present disclosure. In an embodiment, the fifth knotless suture device 400 may further include an interlinking element 408 attached to the first suture holder 402 and / or the second suture holder 404 through a corresponding set of lock pins 410. The lock pins 410 may be configured to extend from the interlinking element408, and configured to fit into holes or provisions defined on the first and the second suture holders 402, 404. Each of the lock pins 410 may have a cylindrical or a prismatic contour with one or more protrusions (two shown in FIGs. 4A and 4B) along a length thereof, which may irreversibly engage with the holes / provisions and prevent the interlinking element 408 from being moved away from the first and / or second suture holders 402, 404.

[0063] Further, in some embodiments, the first and the second suture holders 402 and 404 may include a gap to allow the suture material 114 to be inserted therethrough.

[0064] In some embodiments, the interlinking element 408 may be further configured to operably shift from a neutral position (as shown in FIG. 4D) to a locking position with respect to the first suture holder 402 (as shown in FIG. 4E) and / or the second suture holder 404 (as shown in FIG. 4F).

[0065] In the neutral position, referring to FIG. 4D, the corresponding set of lock pins 410 may separate the interlinking element 408 from the first suture holder 402 and / or the second suture holder 404 by a predetermined distance / gap.

[0066] In the locking position, an inner surface of the first suture holder 402 and / or the second suture holder 404 may be engaged with an interior surface of the interlinking element 408 such that the corresponding set of lock pins 410 secure the engagement between the interlinking element 408 and the first suture holder 402 and / or the second suture holder 404.

[0067] Further, the inner surface and the interior surfaces of the first suture holder 402 and / or the second suture holder 404 may be corrugated, between which the suture material 114 may be locked and secured. In other embodiments, the inner surface and the interior surface may be straight or curved, based on requirements and / or constraints of the use case.

[0068] Referring to FIGs. 4D-4F, a schematic representation of the fifth knotless suture device 400 for suturing is illustrated, in accordance with an embodiment of the present disclosure.

[0069] As illustrated, for suturing the tissue 116, the fifth knotless suture device 400 may be used to secure the suture material 114, after the suture material 114 has been pierced through the tissue 116.

[0070] Further, the suture material 114 may include a second / distal / far end 114a and a first / proximal / near end 114b. In some embodiments, the near end 114b may include a pointed end or a needle configured to pierce through the tissue 116. The near end 114b may be passed / drawn through the gap formed between the interlinking element 408 and the first suture holder 402. Then, the suture material 114 may be locked by pressing the first suture holder 402, thereby locking the suture material 114 using the lock pins 410, and freeing thehands of the surgeon / user to pierce the suture material 114 through tissue 116 (either using bare hands or tools like forceps). The suture material 114 may then be pierced into and through the tissue 116 using the near end 114b. Further, the near end 114b may then be passed through or pushed through the gap formed between the interlinking element 408 and the second suture holder 404, as shown in FIG. 4E-4F. The surgeon / user may pull the suture material 114 in the second direction (i.e., the direction away from the tissue 116) with respect to the first and the second suture holders 402 and 404, up to a desired length to achieve the desired tension for alignment.

[0071] Thereafter, the suture material 114 may be locked by pressing the second suture holder 404 against the interlinking element 408 using the lock pins 410, as shown in FIGs. 4E-4F. The second suture holder 404 may then be employed to lock the near end 114b of the suture material 114, as shown in FIG. 4F, thereby completing the closure. This process effectively eliminates the need for traditional knot-tying in the suturing procedure and reduces the risk of suture loosening or unravelling. The fifth knotless suture device 400 may further ensure that the tension on the suture material 114 is consistent, and does not change during the healing process. The design of the fifth knotless suture device 400 further ensures consistent and secure placement of the suture material 114, enhancing surgical efficiency and reliability, while also being beneficial in delicate procedures where precision and control are essential, as well as in minimally invasive surgeries where limited space complicates traditional suture methods.

[0072] Referring to FIGs. 5A-5B, a schematic front view, and an isometric view of a sixth knotless suture device 500 including a cylindrical locking mechanism are illustrated, and referring to FIGs. 5C-5E, a schematic representation of the sixth knotless suture device 500 used for suturing is depicted, in accordance with an embodiment of the present disclosure. In an embodiment, the sixth knotless suture device 500 may include a suture holder 504 supporting one or more elongated cylinders (such as a first elongated cylinder 502-1 and a second elongated cylinder 502-2) that can abut the suture material 114 against an opposing structure within the suture holder 504 when brought to the locking position to prevent the suture material 114 from moving. In some embodiments, the opposing structure may further include a cavity (e.g., cavities 506-1 and 506-2 corresponding to the elongated cylinders 502-1, 502-2, respectively) such that the one or more elongated cylinders 502 may abut the suture material 114 against contours of the cavity 506. The suture holder 504 may include one or more openings (such as openings 508-1 and 508-2) configured to allow the suture material 114 to be passed therethrough. To lock the suture material 114, the suturematerial 114 may be passed through the openings 508, and the elongated cylinders 502 may be pushed into the suture holder 504 to the locking position such that the elongated cylinders 502 abut against the suture material 114. In some embodiments, the suture material 114 may be attached to a needle that can guide the suture material 114 through the tissue 116, and the suture holder 504. As depicted, for suturing the tissue 116, the sixth knotless suture device 500 as a single suture holder device may be used to secure the suture material 114, after the suture material 114 has been pierced through the tissue 116.

[0073] Referring to FIGs. 5C-5E, the sixth knotless suture device 500 may be configured to allow the near end 114b of the suture material 114 to be passed through one of the openings 508 (such as the opening 508-1). The near end 114b may be pulled up to a desired length, before the first elongated cylinder 502-1 is pushed into the suture holder 504 to lock the far end 114a of the suture material 114, as shown in FIG. 5C.

[0074] Once the far end 114a of the suture material 114 is locked by the first elongated cylinder 502-1, the surgeon / user may pierce the near end 114b of the suture material 114 through the tissue 116. The suture material 114 may be pulled further until the tissues 116 are drawn together to the desired tension or alignment. Then, the near end 114b may be passed through the opening 508-2 corresponding to the second elongated cylinder 502-2, as shown in FIG. 5D. The second elongated cylinder 502-2 may then be employed to lock the near end 114b of the suture material 114, as shown in FIG. 5E, thereby completing the closure. This process too effectively eliminates the need for traditional knot-tying in the suturing procedure and reduces the risk of suture loosening or unravelling. The sixth knotless suture device 500 may further ensure that the tension on the suture material 114 is consistent, and does not change during the healing process. The design of the sixth knotless suture device 500 further ensures consistent and secure placement of the suture material, enhancing surgical efficiency and reliability. Such knotless suturing devices are particularly beneficial in delicate procedures where precision and control are essential, as well as in minimally invasive surgeries where limited space complicates traditional suture methods.

[0075] While the aforementioned embodiments describe the sixth knotless suture device 500 having two elongated cylinders 502 allowing bidirectional movement of the suture material 114 through corresponding gaps / orifices thereof, in other embodiments, at least one of the elongated cylinders 502 may be adapted to allow for unidirectional movement through the gaps thereof.

[0076] In some embodiments, multiple knotless / knot-free suture devices may be arranged in an array. In such embodiments, the array may be made of any one or acombination of the first, second, third, fourth, fifth, or sixth knotless suture devices 100 to 500. In some embodiments, the array may be manufactured as a series of knotless suture devices physically connected by a link. The physical links may connect one suture holder of one knotless suture device to another suture holder of another knotless suture device. Each of the knotless suture devices may be arranged linearly, and up to a predetermined length. The surgeon or medical professional may cut a strip / array of the knotless suture devices for a desired length, based on length of the wound / tissue to be sutured, for example. In some embodiments, once the suture material is locked within one of the suture holders of the initial knotless suture devices, the suture holders may serve as anchors while staying in position with respect to the wounds / tissues, thereby freeing up one hand of the surgeon / medical practitioner which otherwise would have been required to hold the suture material in place to maintain suture pressure / force. Further, through use of arrays / series of the knotless suture devices, the surgeon / medical practitioner may be allowed to not only provide simple sutures, but also other suture patterns such as interrupted suture patterns.

[0077] In additional applications, the arrays / series of knotless suture devices may be arranged in a ring-like pattern or an annular pattern. Such arrangements may be useful in procedures such as anastomosis, where suturing needs to be performed circumferentially around the tissue (to join two tube-like structures, such as intestines or blood vessels). In such applications, the array / series of knotless suture devices arranged in the annular pattern may enable surgeons / medical practitioners to use knotless suture device strips of standardized lengths, and conveniently suture the tissues. Since the knotless suture holders may serve as an anchor once the suture materials are locked with respect to the suture holders (which may either allow unidirectional or bidirectional movement of the suture material therethrough until they are brought to the locked position), both hands of the surgeon may be freed for conveniently suturing the wound / tissues, thereby making the suturing process simple, accurate, and more consistent.

[0078] Further, the annular or linear strip of the knotless suture devices may include different types or a heterogenous set of the suture holders (100, 200, 300a, 300b, 400, 500) may be intermingled to achieve full thickness bites or angled to achieve partial bites, for example including serosa and submucosa layers and leaving mucosal layer by controlling the present suture entry and exit and spacing them alternatively between the suture bites. Further, between any two suture holders of the knotless suture device, any number and / or type of sutures may be run through the wounds.

[0079] This can be applied to one type of suturing pattern also. The purpose is to elevate standard of care, avoid leaks, and simplify the procedure and reduce complications. The knotless suture device may improve the standard of care provided to patients. For example, to suture a 3cm incision on patients of a certain demographic, if it is recommended that the suture material to bites at every 5mms, the arrays of the knotless suture holders may be arranged to enable the suture material to bite and lock position thereof every 5mm along the length of the incision / tissue. Since the arrays / strip of the knotless suture holders may be manufactured consistently and distributed across the globe, the same standard of care may be provided by all medical practitioners having access to the knotless suture device, thereby improving consistency, predictability, and safety, while also minimizing human errors. Given that the knotless suture devices reduce reliance on the skill of the surgeon / user by eliminating / minimizing actions to be performed by the surgeon / user, compliance to the standard of care (as determined from research) may be increased. Further, the knotless suture devices of the present disclosure ensure that the suturing process is executed in a highly standardized and controlled manner, thereby substantially eliminating variability and the potential for human error. The design of the knotless suture device inherently restricts the number of ways in which the suturing process can be performed, ensuring adherence to predefined procedural protocols and effectively removing opportunities for deviation or mistake. This design characteristic facilitates compliance with evidence-based standards of care and enhances procedural consistency across diverse medical practitioners and environments. Further, there is significant data already on superior standard of care recommendations that would benefit from automated labelling in favour of simplicity for compliance and elevation of the standard of care.

[0080] In another aspect, the knotless suture device may include grip facilitators for first and / or second suture holders, which may involve any mechanical grip facilitator option for holding a plain or corrugated suture material to replace necessity for knot in suturing. Additionally, once the suturing is complete, the needle may be removed and the excess suture material may be trimmed.

[0081] Further, referring to FIG. 6A, a schematic view of a seventh knotless suture device 600 is depicted, and referring to FIG. 6B, a schematic representation of the knotless suture device used for suturing is illustrated, in accordance with an embodiment of the present disclosure.

[0082] In an embodiment, the knotless suturing device 600 may include a corrugated suture material 602 and a suture holder 604. The suture holder 604 may be attached to a farend 602a of the suture material 602. The suture material 602 may further include a pointed end (at a near end 602b) and can be moveable unidirectionally through the suture holder 604. In some embodiments, the suture material 602 may be attached to a needle 606 on the near end 602b. The length and geometric dimensions of the seventh knotless suture device 600 may be suitably adapted based on the requirements and / or constraints of the use case.

[0083] Further, the suture material 602 may include a linear ratchet rack 602c and the suture holder 604 may include a pawl that may be configured to abut against the linear ratchet rack 602c when the near end 602b of the suture material 602 is pushed through the suture holder 604 in a first direction, and slide over the linear ratchet rack 602c when the suture material 602 is pulled through the suture holder 604 in a second direction, thereby allowing unidirectional movement / passage of the suture material 602 therethrough. The first direction may correspond to the direction from left to right and the second direction may correspond to right to left, from the perspective provided in FIG. 6B.

[0084] During operation, the near end 602b may be pierced through the tissue 116, and then inserted into the suture holder 604. The near end 602b may then be pulled by the surgeon / user, until a desired tension is achieved to hold the tissue 116. Since the suture holder 604 only allows unidirectional movement, the suture holder 604 may hold the suture material 602 (by engaging the pawl against the linear ratchet rack 602c) when the surgeon releases the near end 602b of the suture material 602, thereby securely holding the tension / compression created on the tissue 116.

[0085] Thus, the knotless suture device can be used to hold sutures in place inside and outside of the body of a patient, effectively replacing the knot of the suture. Multiple sutures can be placed with one suture pack.

[0086] Further, knotless suturing is a significant advancement in surgical techniques, addressing various challenges associated with traditional suturing methods that require knots to secure sutures.

[0087] The knotless suture devices of the present disclosure offer reduced complications. Traditional knots can be a nidus for infection because they can trap bacteria. Knotless sutures reduce the amount of foreign material left in the body, thereby decreasing infection risk. Further, knots can irritate surrounding tissues, causing inflammation or discomfort. Knotless sutures eliminate this problem by avoiding bulky knots, thereby promoting healing.

[0088] In an embodiment, the knotless suture devices of the present disclosure eliminate the need for suture knot(s), and is useful to reduce time, effort, surgery cost, pain and discomfort, healing time, and facilitate more attention on consistent apposition / pressure / tension, even placement without variability; and can be used wherever sutures are used including tubular component ligation. For example, the knotless / knot-free suture device of the present disclosure can be used for performing suturing of the various tubular components like vas deferens, blood vessel, etc.

[0089] Also, the knotless / knot-free suture device can comprise two components, one at each end for continuous suture patterns and by placing two bites instead of one before threading suture material through the knotless device.

[0090] Further, the knotless suture devices of the present disclosure provide uniform tension. Knotless suturing techniques allow for more even distribution of tension along the suture line, leading to better wound approximation and potentially faster healing. Also, the knotless suture devices of the present disclosure provide reduced scarring. By avoiding knots, the tension on the wound is more evenly distributed, which can reduce scarring and improve cosmetic outcomes.

[0091] The knotless suture devices of the present disclosure also enhance surgical efficiency and allow for faster procedures. Knotless suturing can be faster, as surgeons do not have to spend time tying knots, which can be particularly advantageous in time-sensitive or complex surgeries. Additionally, the knotless suture devices of the present disclosure simplify the suturing process, especially in minimally invasive or laparoscopic surgeries, where tying knots can be challenging due to limited space and visibility. Further, the knotless suture devices of the present disclosure reduce operator dependence, as the simplification of the process reduces chances of error.

[0092] Further, while embodiments of the present disclosure are described in the context of providing simply interrupted sutures, it may be appreciated by those skilled in the art that other types of suture patterns, such as including, but not limited to, continuous sutures, horizontal mattress sutures, vertical mattress sutures, cruciate sutures, buried sutures, tensionrelieving sutures, specialty sutures, and the like, may also be used along with the knotless / knot-free suture device of the present disclosure. Additionally for continuous suture patterns two or more sets of the knotless suture devices may be used where instead of one bite through the tissue or one round around the tubular structures, it would require mattresstype 2 bites through tissues or 2 rounds around tubular structure(s) to facilitate grip using one suture holder at each end. However, this would make far end grip only needed to prevent displacement of device.

[0093] In an embodiment, a long suture material makes it unwieldy and prone for contamination, and in tight places increases risk of injuries, but the knotless suturing deviceof the present disclosure enables reduction in suture material length by at least 50%, thereby enhancing the ease of use, while placing many knotless sutures using the devices as shown in FIGs. 1-6B. This length reduction in suture material length requirement does not reduce the number of sutures rather it actually increases the number of sutures the user / surgeon can place. The knotless suture device 600 is a single use device, with a suture material component as built-in offering agility where speed matters.

[0094] Additionally, the knotless suture devices of the present disclosure provide versatility, as knotless suturing is particularly useful in areas where it is difficult to tie knots, such as deep within the body or in confined spaces.

[0095] In this specification, unless specifically stated otherwise, the use of the singular includes the plural and the use of “or” means “and / or.” Furthermore, use of the terms “including” or “having” is not limiting. Any range described herein will be understood to include the endpoints and all values between the endpoints. Features of the disclosed embodiments may be combined, rearranged, omitted, etc., within the scope of the disclosure to produce additional embodiments. Furthermore, certain features may sometimes be used to advantage without a corresponding use of other features.

[0096] While the foregoing describes various embodiments of the disclosure, other and further embodiments of the disclosure may be devised without departing from the basic scope thereof. The scope of the disclosure is determined by the claims that follow. The disclosure is not limited to the described embodiments, versions, or examples, which are included to enable a person having ordinary skill in the art to make and use the disclosure when combined with information and knowledge available to the person having ordinary skill in the art.ADVANTAGES OF THE PRESENT DISCLOSURE

[0097] The present disclosure provides an efficient and improved knotless suture device that obviates the above-mentioned limitations of existing systems / devices.

[0098] The present disclosure provides a knotless suture device that facilitates optimum suture closure characteristics with reduced healing time.

[0099] The present disclosure provides reduced complications, reduced scarring, enhanced surgical efficiency, simplified technique, consistency and reliability, less operator dependency, and versatility.

[0100] The present disclosure provides the knotless suture device that replaces suture knot(s) and is useful to reduce time, effort, surgery cost, pain and discomfort, healing time,and facilitates more attention on consistent apposition / pressure / tension, even placement without variability; and can be used wherever sutures are used including tubular component ligation.

[0101] The present disclosure provides the knotless / knot-free suture device for performing suturing of the various tubular structures like vas deferens, blood vessels, etc.

[0102] The present disclosure provides the knotless / knot-free suture device that can perform all patterns of sutures.

[0103] The present disclosure provides the knotless / knot-free suture device with annular or linear strip of suture grip holders.

[0104] The present disclosure provides the knotless / knot-free suture device comprising of two components, one at each end for continuous sutures patterns and by placing two bites instead of one before threading suture material through the knotless device.

[0105] Other advantages of the present disclosure may be apparent from the detailed description.

Claims

We Claim:

1. A knotless suture device, comprising: a first suture holder (102) configured to operably grip a far end (114a) of a suture material (114); and a second suture holder (104) configured to receive and operably grip a near end (114b) of the suture material (114).

2. The knotless suture device as claimed in claim 1, wherein the first suture holder (102) and the second suture holder (104) are attached to form a single component.

3. The knotless suture device as claimed in claim 1, wherein the suture material (114) is moveable bidirectionally through the first suture holder (102) and / or the second suture holder (104), until the suture material (114) is gripped by the first suture holder (102) and / or the second suture holder (104), respectively, using a corresponding gripping assembly.

4. The knotless suture device as claimed in claim 1, wherein the suture material (114) is moveable unidirectionally through the first suture holder (102) and / or the second suture holder (104) to achieve a knotless binding when the force in the opposite direction is blocked.

5. The knotless suture device as claimed in claim 1, wherein the suture material (114) is moveable unidirectionally through the second suture holder (104), and wherein the suture material (114) is moveable bidirectionally through the first suture holder (102), until the far end (114a) of the suture material (114) is gripped by the first suture holder (102) using a first gripping assembly.

6. The knotless suture device as claimed in claim 1, wherein the suture material (114) is moveable unidirectionally through the first suture holder (102), and wherein the suture material (114) is moveable bidirectionally through the second suture holder (104), until the suture material (114) is gripped by the second suture holder (104) using a second gripping assembly.

7. The knotless suture device as claimed in claim 1, wherein, the suture material (114) comprises a linear ratchet rack, and the first suture holder (102) and / or the second suture holder (104) comprises a pawl (214) configured to:abut against the linear ratchet rack when the suture material (114) is moved in a first direction through the first suture holder (102) and / or the second suture holder (104), and slide over the linear ratchet rack when the suture material (114) is moved in a second direction through the first suture holder (102) and / or the second suture holder (104).

8. The knotless suture device as claimed in claim 1, wherein the first suture holder (102) and / or the second suture holder (104) are configured to operably grip the suture material (114) using a corresponding gripping assembly comprising a friction gripping means.

9. The knotless suture device as claimed in claim 8, wherein the friction gripping means comprises: a housing (110) having a set of protrusions (112) arranged to form an orifice, wherein the orifice is configured to allow the suture material (114) to be passed therethrough; and a cap (106) having a set of inclined surfaces configured to abut the set of protrusions (112) when the cap (106) is slid into the housing, wherein the abutting of the set of protrusions (112) causes the orifice to contract and grip the suture material (114).

10. The knotless suture device as claimed in claim 1, further comprises an interlinking element (408) attached to the first suture holder (102) and / or the second suture holder (104) through a corresponding set of lock pins (410), wherein the interlinking element (408) is configured to operably shift from a neutral position to a locking position with respect to the first suture holder (102) and / or the second suture holder (104), and wherein, in the neutral position, the corresponding set of lock pins (410) separate the interlinking element from the first suture holder (102) and / or the second suture holder (104) separated by a predetermined distance, and in the locking position, an inner surface of the first suture holder (102) and / or the second suture holder (104) is in engagement with an interior surface of the interlinking element, wherein the corresponding set of lock pins (410) is configured to secure the engagement between the interlinking element and the first suture holder (102) and / or the second suture holder (104).

11. The knotless suture device as claimed in claim 10, wherein the inner surface and the interior surfaces are corrugated.

12. The knotless suture device as claimed in claim 1, wherein the first suture holder (102) and / or the second suture holder (104) comprise one or more elongated cylinders (502) configured to abut the suture material (114) against an opposing structure within the first suture holder (102) and / or the second suture holder (104) when brought to the locking position to prevent the suture material (114) from moving.

13. The knotless suture device as claimed in claim 1, wherein the opposing structure comprises a cavity (506), and wherein the one or more elongated cylinders (502) abut the suture material (114) against contours of the cavity (506).

14. The knotless suture device as claimed in claim 1, wherein the suture material (114) is attached to a needle, wherein the needle is configured to guide the suture material (114) through a tissue (116), the first suture holder (102), and the second suture holder (104).

15. A knotless suturing device (600), comprising: a suture material (602); and a suture holder (604) attached to a far end (602a) of the suture material (602), wherein the suture material (602) comprises a pointed end and is moveable unidirectionally through the suture holder (604).

16. The knotless suturing device (600) as claimed in claim 15, wherein the suture material (602) is attached to a needle (606) on a near end (602b).

17. The knotless suturing device (600) as claimed in claim 15, wherein the suture material (602) comprises a linear ratchet rack (602c) and the suture holder (604) comprises a pawl configured to abut against the linear ratchet rack (602c) when a near end (602b) of the suture material (602) is pulled / threaded through the suture holder (604) suture material slides over the linear unidirectional ratchet rack (602c), and locks the suture material (602) at a position determined by surgeons.

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