A fixation device for securing a separated osteochondral fragment of a subject

Abstract

A fixation device (100) for securing one or more broken fragments (50a, 50b) of a subject. The device includes a first insertion member (40a) insertable through a central hole (60) defined through the one or more broken fragments (50a, 50b). Further the device includes a plurality of connection members (10a, 10b, 10c, 10d), each of the plurality of connection members defined with a first end (11) and a second end (12). Also, the device includes a suture ring (30) configured to encompass a portion of the plurality of connection members (10a,10b,10c,10d) and is slidably disposed between the first end (11) and the second end (12) of the plurality of connection members.

Description

[0001] A FIXATION DEVICE FOR SECURING A SEPARATED OSTEOCHONDRAL FRAGMENT OF A SUBJECT

[0002] TECHNICAL FIELD

[0003] Present disclosure generally relates to the field of medical devices. Particularly but not exclusively, the present disclosure relates to a fixation device for securing a separated osteochondral fragment of a subject.

[0004] BACKGROUND OF THE DISCLOSURE

[0005] A small broken piece of a bone or a loose fragment is separated from the bone or the joint surfaces due to accidents, falls or medical conditions, thereby resulting in patients being unable to move or perform regular activities for long duration before recovery. These smaller broken piece of bone or cartilage are different from major fractures or large fractures. Generally, such broken pieces or loose fragments are broken off from the bone end i.e. from the joint surfaces; and these fragments are very small measuring 1-4 cm2only. While, large and major fractures of the bones are treated by rods, nails, plates etc, the same would not be applicable for joining small pieces of broken bones. The small pieces of broken bones are generally secured using small metallic fixation devices like herbert screws, headless screws, k-wires etc. or are treated using bioabsorbable fixation devices like absorbable screws, bio-absorbable pins, darts etc. The use of metallic fixation device would necessitate leaving a metal implant inside the patient’s joint which must be removed at the later stage. As the metal implant is intra-articular, a second surgery is always necessary to remove the metal implant. If metal implants are left inside for a long duration, then there is high chance of articular surface erosion and development of arthritis.

[0006] Further, to overcome the deficiencies associated with the metal implants, the bio-absorbable devices are employed. However, the bio-absorbable implants pose very own set of challenges including difficultly in implanting and having limited fixation strength and may carry a huge risk of chemical reaction, more specifically in intra-articular locations. In addition to the described deficiencies, both the metal and bio-absorbable implant devices often fail to hold small fragments, as the small fragments develop a crack while using pins / screws / darts etc. These devices are also not good while fixing pure chondral loose piece or soft tissues. Furthermore, in conventional implants, while securing the broken bone during surgery, the conventional implants fail to uniformly distribute compressive force applied on the bone to ensure healing at predefined locations. Such non-uniform force distribution leads to improper healing of the bone or in some instances causes further damage to the bone.

[0007] The present disclosure is directed to overcome plurality limitations stated above or any other limitation associated with the conventional arts.

[0008] The information disclosed in this background of the disclosure section is only for enhancement of understanding of the general background of the invention and should not be taken as an acknowledgement or any form of suggestion that this information forms the prior art already known to a person skilled in the art.

[0009] SUMMARY OF THE DISCLOSURE

[0010] One or more shortcomings of the conventional systems are overcome by the device of the present disclosure.

[0011] In an non-limiting embodiment of the present disclosure, a fixation device for securing one or more broken fragments of a subject is disclosed. The device includes a first insertion member insertable through a central hole defined through the one or more broken fragments. Further, the device includes a plurality of connection members. Each of the plurality of connection members is defined with a first end and a second end. The first end of each of plurality of the connection members is connected to the first insertion member. Furthermore, the device includes a plurality of second insertion members. Each of the plurality of second insertion members being connected to corresponding second ends of the plurality of connection members. Also, the device includes a suture ring configured to encompass / host / house a portion of the plurality of connection members and is slidably disposed between the first end and the second end of the plurality of connection members.

[0012] In an embodiment of the present disclosure, the first insertion member and the plurality of second insertion members is one of a surgical needle or a thickened suture.

[0013] In an embodiment of the present disclosure, the plurality of connection members are at least one of a suture or a surgical tape.

[0014] In an embodiment of the present disclosure, the plurality of connection members are made of a bio-degradable or bio-compatible material. In an embodiment of the present disclosure, suture ring comprises one or more sutures braided / woven to form the suture ring.

[0015] In an embodiment of the present disclosure, the suture ring is made of a bio-degradable or biocompatible material.

[0016] In an embodiment of the present disclosure, the broken fragments being defined with a first portion and a second portion.

[0017] In an embodiment of the present disclosure, the second insertion members are insertable through a plurality of secondary holes defined around the central hole.

[0018] In a non-limiting embodiment of the present disclosure, a suture ring for a fixation device is disclosed.

[0019] In an embodiment of the present disclosure, the device includes one or more surgical strips braided with each other to form the suture ring and configured to distribute compression force uniformly over the one or more broken fragments to allow uniform healing of the bone.

[0020] In an embodiment of the present disclosure, the surgical strips are made of bioabsorbable material or biocompatible material.

[0021] It is to be understood that the aspects and embodiments of the disclosure described above may be used in any combination with each other. Several of the aspects and embodiments may be combined together to form a further embodiment of the disclosure.

[0022] The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description.

[0023] BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWING

[0024] The novel features and characteristic of the disclosure are set forth in the appended description. The disclosure itself, however, as well as a preferred mode of use, further objectives, and advantages thereof, will best be understood by reference to the following description of an illustrative embodiment when read in conjunction with the accompanying figures. One or more embodiments are now described, by way of example only, with reference to the accompanying figures wherein like reference numerals represent like elements and in which:

[0025] Fig. 1 illustrates a schematic view of a bone fixation device for suturing a loose piece or a fragment of a native bone, in accordance with an embodiment of the disclosure.

[0026] Fig. 2 illustrates a schematic view of a damaged bone which can be fixed by the device of Fig. 1, in accordance with an embodiment of the disclosure.

[0027] The figures depict embodiments of the disclosure for purposes of illustration only. One skilled in the art will readily recognize from the following description that alternative embodiments of the assembly illustrated herein may be employed without departing from the principles of the disclosure described herein.

[0028] DETAILED DESCRIPTION OF THE DISCLOUSRE

[0029] The foregoing description broadly outlines the features and technical advantages of the present disclosure in order that the description of the disclosure that follows may be better understood. Additional features and advantages of the disclosure will be described hereinafter which form the subject of the disclosure. It should be appreciated by those skilled in the art that the conception and specific embodiment disclosed may be readily utilized as a basis for modifying or designing other vehicles for carrying out the same purposes of the present disclosure. It should also be realized by those skilled in the art that such equivalent constructions do not depart from the scope of the disclosure. The novel features which are believed to be characteristic of the disclosure, as to its organization, together with further objects and advantages will be better understood from the following description when considered in connection with the accompanying figures. It is to be expressly understood, however, that each of the figures is provided for the purpose of illustration and description only and is not intended as a definition of the limits of the present disclosure.

[0030] In the present document, the word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment or implementation of the present subject matter described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments. While the disclosure is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and will be described below. It should be understood, however, that it is not intended to limit the disclosure to the particular forms disclosed, but on the contrary, the disclosure is to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure.

[0031] The term “subject” in the foregoing description may refer to human or an animal having bones and cartilages.

[0032] The term “osteochondral” refers to part of either a bone or a cartilage or both in a joint of the subject, while term “osteochondral fragment” refers to piece of either a bone or a cartilage or a combined piece.

[0033] The terms “comprises.. a”, “comprising”, or any other variations thereof, are intended to cover a non-exclusive inclusions, such that an assembly that comprises a list of components does not include only those components but may include other components not expressly listed or inherent to such assembly. In other words, one or more elements in the vehicle or assembly proceeded by “comprises... a” does not, without more constraints, preclude the existence of other elements or additional elements in the assembly.

[0034] In the following description of the embodiments of the disclosure, reference is made to the accompanying figure that form a part hereof, and in which are shown by way of illustration specific embodiments in which the disclosure may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the disclosure, and it is to be understood that other embodiments may be utilized and that changes may be made without departing from the scope of the present disclosure. The following description is, therefore, not to be taken in a limiting sense.

[0035] Fig. 1 illustrates a schematic representation of a fixation device (100) for securing a separated osteochondral fragment of a subject. In an embodiment, osteochondral fragment may correspond to a broken piece of the bone (50), a loose fragment of the bone (50), a damaged cartilage, an intra-articular or juxta- articular fragment of the bone (50) or an avulsed ligament of the bone (50). The device (100) comprises a first insertion member (40a) and a plurality of connection members (10a, 10b, 10c, lOd), where one end of the plurality of connection members (10a, 10b, 10c, lOd) are connectable to the first insertion member (40a). The first insertion member (40a) is defined with a length and width. The length and width of the first insertion member (40a) may vary depending upon type and size of the broken piece of the bone (50) or loose fragment of the bone (50) or damaged cartilage. The first insertion member (40a) is also defined with a stiffness for maintaining the structural integrity of the first insertion member (40a). In an embodiment, the first insertion member (40a) may be a needle of predefined length and diameter. In an embodiment, the first insertion member (40a) may be a thickened suture. The plurality of connection members (10a, 10b, 10c, lOd) are flexible elements of the device (100) defined with a length and stiffness. In an embodiment, the plurality of connection members (10a, 10b, 10c, lOd) may be at least one of a suture or a surgical tape.

[0036] The device (100) includes a fixation node (20) positioned along a length of the plurality of connection members (10a, 10b, 10c, lOd). In one instance, the plurality of connection members (10a, 10b, 10c, lOd) may be merged or fused to form the fixation node (20). Further, the device (100) may include a suture ring (30) positioned between the first end (11) of the plurality of connection members (10a, 10b, 10c, lOd) and the second end (12) of the plurality of connection members (10a, 10b, 10c, lOd) configured to accommodate the plurality of connection members (10a, 10b, 10c, lOd). The suture ring (30) hosts or houses the portion of the plurality of connection members (10a, 10b, 10c, lOd) maybe slidable along the length of the plurality of connecting members (10a, 10b, 10c, lOd). The suture ring (30) may include one or more surgical strips looped and braided with each other to form the surgical ring. The surgical strips may correspond to sutures, or strips made of biodegradable material or bioabsorbable material. Braiding the surgical strips provides structural strength to the suture ring (30). Furthermore, the device (100) includes a plurality of second insertion members (40b) which are connectable to the free end of the plurality of connection members (10a, 10b, 10c, lOd). The second insertion members (40b) are defined with a length and width. The second insertion members (40b) are also defined with a stiffness for maintaining the structural integrity of the second insertion members (40b). In an embodiment, the second insertion members (40b) may be a needle of predefined length and diameter. In another embodiment, the second insertion members (40b) may be a thickened suture.

[0037] In an embodiment, the device (100) may be used to suture a loose fragment. The expression “loose fragment” used hereinafter and above refers to either a loose small piece of the bone (50), or the piece of the bone (50) with cartilage on it or a pure cartilage piece or a piece of the bone (50) attached to an avulsed ligament, or a piece of fibrous tissues attached with an avulsed ligament etc.

[0038] The fixation device (100) also referred to as “device (100)”, is used for suturing a loose piece / fragment of a broken piece of the bone (50). In an operational embodiment as illustrated in Fig. 2, considering the bone (50) is broken into two fragments (50a, 50b) having a first portion (50a) and second portion (50b). The first portion (50a) may correspond to a piece of the bone (50) such as a patella bone with broken piece being a small loose fragment. Initially, the surgeon may drill a hole passing through the first portion (50a) of the bone (50) as shown in Fig 2, and also through the second portion (50b) from where the first portion (50a) has separated. The hole passing through these two portions of the bone (50) may be termed as central hole (60). Further, a plurality of holes (70a, 70b, 70c, 70d) may be drilled away from the central hole (60). The first insertion member (40a) may pass through the central hole (60) from a first portion (50a) to a second portion (50b) completely. The first insertion member (10) after passing though the central hole (60) may be separated from the plurality of connection members (10a, 10b, 10c, lOd) by cutting the connection members (10a, 10b, 10c, lOd). In an illustrative embodiment as shown in Fig. 1, the fixation device (100) may include but not limited to four second insertion members (40b). Further, at least one of the pluralities of second insertion members (40b) may pass through at least one of the plurality of holes (70a, 70b, 70c, 70d). At least one of the pluralities of second insertion members (40b) may initially pass through the first hole (70a) and further gets tied in form of a type of a surgical knot with the corresponding connection members (10a) at the end of the second portion (50b) of the bone (50). The next member of the plurality of second insertion members (40b) may pass through a second hole (70b) and further gets tied in form of a type of a surgical knot with the corresponding connection members (10b) at the end of the second portion (50b) of the bone (50). Further, next member of the plurality of second insertion members (40b) may then pass through a third hole (70c) and further gets tied in form of a type of a surgical knot with the corresponding next insertion member at the end of the second portion (50b) of the bone (50). In an embodiment, fourth member of the plurality of second insertion members (40b) may pass through a fourth hole (70d) and further pass through gets tied in form of a type of a surgical knot with the corresponding fourth insertion member at the end of the second portion (50b) of the bone (50). Each of the second insertion members (40b) tied with the plurality of connection members (10a, 10b, 10c, lOd) may be pulled to impart a cinching effect and thereby imparting a compressive action on the two portions of the broken piece of the bone (50). Such compressive action may assist in healing of the broken piece of the bone (50). Furthermore, the suture ring (30) is configured to distribute compression force uniformly along the smaller fractured fragment to allow uniform healing of the bone (50). Alternatively, the suture ring (30) may be configured to fanout the surgical strips in around the broken piece of the bone (50) to have a gripping effect on the broken piece of the bone (50).

[0039] The fixation device (100) is simple and cost effect device (100) for suturing the broken piece of the bone (50) to a native bone (50). The added compressive action due to the cinching force provided by the sequential tying of the knots and the compressive force provided by the suture ring (30) may assist in quick healing of the bone (50).

[0040] The fixation device (100) can be made of absorbable material for intra-articular locations which may eliminate complications associated with existing methods of metal screws / pin or bio-pins. While fixation device (100) is recommended to be made of absorbable suture materials for intra-articular locations, a non-absorbable suture material may be used for extra-articular locations.

[0041] The fixation device (100) along with the suture ring (30) when made of absorbable sutures is to be used in intra-articular locations where the whole device (100) may easily dissolve within a patient’s body and doesn’t require a separate operation to remove the sutures. Over a period of time, use of dissolvable suture materials results in dissolving of the whole fixation device (100) around the native bone (50) without any remnant of the fixation device (100) left inside the subject. However, at some crucial areas or in extra-articular locations, a non-absorbable suture might be needed. The fixation device (100) along with the suture ring (30) when made of non-absorbable suture is to be used in extra- articular locations where the primary aim is not to get the fixation device (100) fully absorbed but to provide a suture based device (100) to fix small fragments outside the joints such as avulsion fracture of ligaments.

[0042] With respect to the use of substantially any plural and / or singular terms herein, those having skill in the art can translate from the plural to the singular and / or from the singular to the plural as is appropriate to the context and / or application. The various singular / plural permutations may be expressly set forth herein for sake of clarity. While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purpose of illustration and are not intended to be limiting. REFERENCE NUMERALS EQUIVALENTS:

[0043] The embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practised and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.

[0044] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and / or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practised with modification within the spirit and scope of the embodiments as described herein.

[0045] Throughout this specification the word “comprise”, or variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

[0046] The use of the expression “at least” or “at least one” suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the disclosure to achieve one or more of the desired objects or results.

[0047] Any discussion of documents, acts, materials, devices, articles and the like that has been included in this specification is solely for the purpose of providing a context for the disclosure. It is not to be taken as an admission that any or all of these matters form a part of the prior art base or were common general knowledge in the field relevant to the disclosure as it existed anywhere before the priority date of this application. The numerical values mentioned for the various physical parameters, dimensions, or quantities are only approximations and it is envisaged that the values higher / lower than the numerical values assigned to the parameters, dimensions or quantities fall within the scope of the disclosure, unless there is a statement in the specification specific to the contrary.

[0048] While considerable emphasis has been placed herein on the particular features of this disclosure, it will be appreciated that various modifications can be made and that many changes can be made in the preferred embodiments without departing from the principles of the disclosure. These and other modifications in the nature of the disclosure or the preferred embodiments will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.

Claims

We Claim:

1. A fixation device (100) for securing one or more broken fragments (50a, 50b) of a subject comprising: a first insertion member (40a) insertable through a central hole (60) defined through the one or more broken fragments (50a, 50b); a plurality of connection members (10a, 10b, 10c, lOd), each of the plurality of connection members (10a, 10b, 10c, lOd) defined with a first end (11) and a second end (12), wherein the first end (11) of each of plurality of the connection members (10a, 10b, 10c, lOd) being connected to the first insertion member (40a); a plurality of second insertion members (40b), each of the plurality of second insertion members (40b) being connected to corresponding second end (12) of the plurality of connection members (10a, 10b, 10c, lOd); a suture ring (30) configured to encompass / host / house a portion of the plurality of connection members (10a, 10b, 10c, lOd) and is slidably disposed between the first end (11) and the second end (12) of the plurality of connection members (10a, 10b, 10c, lOd);2. The fixation device (100) as claimed in claim 1, wherein the first insertion member (40a) and the plurality of second insertion members (40b) is one of a surgical needle or a thickened suture.

3. The fixation device (100) as claimed in claim 1, wherein the plurality of connection members (10a, 10b, 10c, lOd) are at least one of a suture or a surgical tape.

4. The fixation device (100) as claimed in claims 1 and 3, wherein the plurality of connection members (10a, 10b, 10c, lOd) are made of a bio-degradable or bio-compatible material.

5. The fixation device (100) as claimed in claim 1, wherein the suture ring (30) comprises one or more sutures braided / woven to form the suture ring (30).

6. The fixation device (100) as claimed in claim 1, wherein the suture ring (30) is made of a bio-degradable or bio-compatible material.

7. The fixation device (100) as claimed in claim 1, wherein the broken fragments being defined with a first portion (50a) and a second portion (50b).

8. The fixation device (100) as claimed in claim 1, wherein the second insertion members (40b) are insertable through a plurality of holes (70a, 70b, 70c, 70d) defined around the central hole (60).

9. A suture ring (30) for a fixation device (100) as claimed in claim 1.

10. The suture ring (30) as claimed in claim 9 comprising one or more surgical strips braided with each other to form the suture ring and configured to distribute compression force uniformly over the one or more broken fragments (50a, 50b) to allow uniform healing of the bone (50).

11. The suture ring (30) as claimed in claim 9, wherein the surgical strips are made of bioabsorbable material or biocompatible material.

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