Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

1. TITLE OF THE INVENTION:
IMPLANT ASSIST DEVICE

2. APPLICANT:
Meril Healthcare Pvt. Ltd., an Indian company of the Survey No. 135/139, Bilakhia House, Muktanand Marg, Chala, Vapi- 396191, Gujarat, India.

The following specification particularly describes the invention and the manner in which it is to be performed:

FIELD OF INVENTION
[001] The present disclosure discloses a medical device. In particular, the present disclosure relates to an implant assist device.
BACKGROUND OF INVENTION
[002] Joint replacement is a surgical procedure in which a diseased joint or portions thereof are replaced with a prosthesis (or implant). These prostheses are specially designed to restore healthy movement/function of the diseased joint. During such surgical procedures, a stem-like prosthesis is inserted and fixed within a bone(s) adjacent to the joint being replaced.
[003] Often times, with time, the implanted prosthesis becomes loose and/or dislocated. The said phenomenon is most common with osteoporotic patients.
[004] Further, conventionally available implant assist device used to stabilize the implanted prosthesis, fail to provide modularity at the time of implantation. For example, basis the diameter of the bone canal, some implant assist devices are rendered outright incompatible. This phenomenon necessitates the physician to check multiple implant assist devices with varying diameters at their disposal to find the right fit which complicates the surgical procedure and increases surgical time.
[005] Thus, there arises a need for a device that overcomes the problems associated with the conventional implant assist device.
SUMMARY OF INVENTION
[006] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
[007] The present disclosure relates to a device having a proximal end, a distal end, a body and at least one wing. The body includes a cavity and at least one coupling section. The cavity extends axially from the proximal end towards the distal end. The cavity is configured to receive at least a portion of a stem-like prosthesis. The coupling section is provided in an outer surface of the body and towards the distal end. The wing has a distal portion. The distal portion of the wing is removably coupled to the coupling section of the body thereby enabling the wing to pivot in a to-and-fro motion with respect to the body.
BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS
[008] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[009] Fig. 1 depicts a device 100 along with a stem-like prosthesis 10 according to an embodiment of the present disclosure.
[010] Fig. 2 depicts the device 100 according to an embodiment of the present disclosure.
[011] Fig. 3 depicts a wing 130 of the device 100 according to an embodiment of the present disclosure.
[012] Fig. 4 depicts a coupling section 115 of a body 110 of the device 100 according to an embodiment of the present disclosure.
[013] Fig. 4a depicts an enlarged cross-sectional view of the body 110 of the device 100 according to an embodiment of the present disclosure.
Detailed Description of the Drawings
[014] Prior to describing the disclosure in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like. Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.
[015] Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment, but mean “one or more but not all embodiments” unless expressly specified otherwise. The terms “including,” “comprising,” “having,” and variations thereof mean “including but not limited to” unless expressly specified otherwise. An enumerated listing of items does not imply that any or all of the items are mutually exclusive and/or mutually inclusive, unless expressly specified otherwise. The terms “a,” “an,” and “the” also refer to “one or more” unless expressly specified otherwise.
[016] Although the operations of exemplary embodiments of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that the disclosed embodiments can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular embodiment are not limited to that embodiment, and may be applied to any embodiment disclosed herein. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses.
[017] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[018] The present disclosure discloses an implant assist device (or device). The device of the present disclosure is coupled to a distal end of a stem-like prosthesis to provide proper fixation during cemented fixation of the stem-like prosthesis. The stem-like prosthesis may be a stem prosthesis used in joint replacement surgical procedures, for example, total knee arthroplasty (TKA), total hip arthroplasty (THA) or total shoulder arthroplasty (TSA), etc.
[019] The device of the present disclosure is provided with a plurality of wings removably coupled to a body. The wings operatively engage an inner wall of the Intramedullary (IM) canal of the bone, enhancing stability and preventing prosthesis migration. The wings also promote uniform distribution of the cement mantle around both the stem-like prosthesis and the device. Uniform distribution of the cement mantle is essential for achieving robust cement fixation and ensuring long-term success of the prosthesis.
[020] The device provides modularity due to which the number of wings coupled to the device may either be increased or decreased depending on the diameter of a bone canal in which it is being implanted. For example, the device may be implanted with only one wing in small diameter bone canals or the device may be implanted with three wings in large diameter bone canals. Accordingly, multiple dies for manufacturing the implant assist devices with varying diameters is eliminated, enabling cost-effective production. Not only this provides economical production cost for the manufacturer, it makes the entire surgical procedure economical for the end user as well. Further, the removably coupled wings reduces the complexity of the surgical procedures as the medical practitioner is not required to check upon multiple devices of varying diameters to find the right fit and hence, it saves surgical time as well.
[021] Now referring to the figures, Fig. 1 depicts a device 100 coupled to a distal end of a stem-like prosthesis 10. The stem-like prosthesis 10 may be a stem prosthesis used in joint replacement surgical procedures, for example, total knee arthroplasty (TKA), total hip arthroplasty (THA) or total shoulder arthroplasty (TSA), etc. The device 100 is an implant assist device used to provide proper fixation of the stem-like prosthesis 10 during cemented fixation of the stem-like prosthesis 10 in a body (or bone) canal.
[022] Fig. 2 illustrates the device 100 according to an embodiment of the present disclosure. The device 100 provides precise implant placement and uniform cement distribution. The device 100 has a proximal end 100a and a distal end 100b. The device 100 includes at least a body 110, and a plurality of wings 130 removably coupled to the body 110. Removable coupling of the wings 130 to the body 110 enhances modularity of the device 100 and enables a medical practitioner to use the same device 100 in both small and large diameter body canals or the like for implantation of the stem-like prosthesis 10. For example, the device 100 may be used with only one wing 130 when implanted within small diameter canals or the like. Or, the device 100 may be used with three wings 130 when implanted within large diameter canals or the like. Further, a medical practitioner may at their will, decide the number of wings 130 required for implantation basis their judgement.
[023] The body 110 and the wings 130 may be made of a material including, but not limited to, polymethyl methacrylate (PMMA), ultra-high-molecular-weight polyethylene (UHMWPE), polyether ether ketone (PEEK), or other biocompatible materials, etc. In an exemplary embodiment, the body 110 and the wings 130 are made of PMMA and UHMWPE respectively.
[024] The body 110 may have a pre-defined shape including but not limited to cylindrical, conical, etc. In an exemplary embodiment, as shown in Fig. 2, the body 110 has a cylindrical shape with tapering distal portion. The body 110 may have a length and diameter depending upon a size of the stem-like prosthesis 10 and/or the anatomy of the implantation site. An outer surface of the body 110 provides stable cement bonding between the device 100 and the bone canal.
[025] The body 110 defines a cavity 111 extending axially from the proximal end 100a towards the distal end 100b of the device 100. The cavity 111 is configured to receive at least a portion of the distal end of a stem-like prosthesis 10 (as shown in Fig. 1) thereby, securing the stem-like prosthesis to the device 100. The cavity 111 may have dimensions reciprocating the dimensions of a portion of the stem-like prosthesis 10. In an exemplary embodiment, the dimensions of the cavity 111 reciprocates the dimensions of a distal portion of the stem-like prosthesis 10.
[026] In an exemplary embodiment, the cavity 111 is tapered from the proximal end 100a to the distal end 100b to provide a snug fit to the stem-like prosthesis 10. The said tapering of the cavity 111 allows the stem-like prosthesis 10 to gradually sink in, ensuring optimal engagement before being securely taper locked to the body 110.
[027] At the distal end 100b, the body 110 may include a rounded edge 113. The rounded edge 113 may either be integrally formed with the body 110 or removably coupled to the body 110. The rounded edge 113 may have a pre-defined shape including but not limited to hemispherical, conical, bullet shaped, etc. In an exemplary embodiment, as shown in Fig. 2, the rounded edge 113 is hemispherically shaped and forms an integral structure with the body 110. The rounded edge 113 provides even flow of the cement and enhances the distribution of the cement mantle during implantation. The rounded edge 113 confirms a firm and precise fit, minimizing potential prosthesis migration and ensures optimal alignment of the stem-like prosthesis 10.
[028] To the body 110, one or more wings 130 are attached. The body 110 includes a coupling section (depicted in Fig. 4 as 115) provided towards its distal end 100b. For example, coupling section 115 is provided in an outer surface of the body (110). The number of coupling sections correspond to the number of wings that can be coupled to the body 110. In an exemplary embodiment, the body 110 is provided with three coupling sections 115, each of which can be coupled to a respective wing 130 via a C-shaped section described below.
[029] Although the body 110 of the present disclosure is descried with only three coupling sections 115, the body 110can be manufacture with any number of coupling sections 115. Accordingly, the medical practitioner, at the time of implantation, will decide the number of wings 130 to be coupled to the body 110 and the same is within the scope of the teachings of the present disclosure.
[030] Alternatively or additionally, the body 110 is provided with a pre-defined number of wings 130 coupled to the body 110. Accordingly, the medical practitioner, at the time of implantation, will decide the number of wings 130 to be decoupled from the body 110 and the same is within the scope of the teachings of the present disclosure.
[031] In an embodiment, a wing 130 includes a proximal portion 131, a wing body 133, and a distal portion 135 (depicted in Fig. 3). The wing 130 helps to secure the stem-like prosthesis within the bone canal facilitating even cement distribution.
[032] The proximal portion 131 of the wing 130 may extend beyond the proximal edge of the body 110 providing enhanced range of flex for the wings 130 with respect to the body 110. The proximal portion 131 may have a pre-defined shape including, but not limited to, a semi-circular edge with a quadrangular shape, rectangular shape, etc. In an exemplary embodiment, the proximal portion 131 has a semi-circular edge with tapering body. The taper extends from the proximal to the distal end of the proximal portion 131. The proximal portion 131 may have a curved profile, i.e., an inner surface of the proximal portion 131 may be concave and an outer surface of the proximal portion 131 may be convex. The proximal portion 131 helps to easily slide the device 100 into the bone canal or the like.
[033] In an alternate embodiment, the proximal portion 131 may include one or more teeth rather than a smooth rounded edge. This may help to better fixation.
[034] The wing body 133 may have a pre-defined shape including but not limited to, triangular, rectangular, trapezoidal, etc. shapes. In an exemplary embodiment, as shown in Fig. 4, the wing body 133 is quadrangular shaped and corresponds to the contours of the outer surface of the body 110. The wing body 133 may be tapered as depicted or of constant width.
[035] The distal portion 135 removably couples the wings 130 to the body 110. In an exemplary embodiment, the distal portion 135 includes a C-shaped section defined by a first member 135a, a second member 135b and a strip 135c coupling the first member 135a to the second member 135b. The C-shaped section defines a groove 135d when viewed from the outer side of the distal portion 135.
[036] The C-shaped section may protrude towards the inner side (or towards the body 110) with respect to the plane defined by the wing body 133. The C-shaped section and the groove 135d therein, enable engagement of the wing 130 within the body 110.
[037] Referring to Fig. 4, the coupling section 115 includes at least a first window 115a, and a second window 115b. The second window 115b is disposed closer to the rounded edge 113 of the distal end 110b.
[038] The first window 115a and the second window 115b are provided in an axial direction and spaced from each other. For example, the first window 115a and the second window 115b may be separated by a bridge portion 115c defined in the body 110. A pre-defined length of the bridge portion 115c may correspond to the thickness of the groove 135d of the wing 130 as the groove 135d of the wing 130 is configured to mate with the bridge portion 115c to secure the wings 130 with the body 110.
[039] In an exemplary embodiment, the first window 115a, the second window 115b and the bridge portion 115c therebetween at least partially enable the wing 130 to pivot in a to-and-fro motion.
[040] The dimensions of the first window 115a correspond to the dimensions of the first member 135a of the wings 130. Similarly, the dimensions of the second window 115b correspond to the dimensions of the second member 135b of the wings 130. For instance, dimensions include the length and width of the respective component.
[041] An exemplary enlarged cross-sectional view of the first window 115a and the second window 115b is depicted in Fig. 4a. The first window 115a may be defined by a plurality of chamfered surfaces 115a1. The chamfered surfaces 115a1 ensures easy coupling of the wings 130 with the body 110. Optionally, the second window 115b may also be defined by a plurality of chamfered surfaces (not shown).
[042] A plurality of inclined surfaces 115b1 may be disposed within the cavity 111 of the body 110 such that at least one inclined surface 115b1 is disposed adjacent to the second window 115b. The inclined surface 115b1 may have a first edge 115b2 and a second edge 115b3. In an exemplary embodiment, as shown in Fig. 4a, the first edge 115b2 is an edge of the second window 115b towards the distal end 100b of the device 100. The inclined surface 115b1 helps to prevent the wings 130 from dislocating or loosening after the wings 130 are coupled to the body 110.
[043] The second edge 115b3 of the inclined surface 115b1 may be disposed relatively interior of the cavity 111 than the first edge 115b2, thus providing a pre-defined inclination to the inclined surface 115b1. An inclination angle defined between the second window 115b and the inclined surface 115b1 may correspond to the shape of the second block of the wings 130 (described later).
[044] Once a wing 130 is inserted in the coupling section 115, the distal portion 135 of the wing 130 is operationally coupled to the respective coupling section 115 of the body 110 to enable the wings 130 to pivot in a to-and-fro motion. Specifically, the first member 135a of the wing 130 is operationally coupled to the first window 115a of the body 110. The second member 135b may be operationally coupled to the second window 115b of the body 110. This manner of coupling enables swift and reliable attachment and detachment of the wings 130 with the body 110.
[045] The first member 135a of the wing 130 may be shaped and dimensioned corresponding to the first window 115a and the chamfered surfaces 115a1 of the body 110. Similarly, the second member 135b of the wing 130 may be shaped and dimensioned corresponding to the second window 115b and the inclined surface 115b1 of the body 110.
[046] The groove 135d of the wing 130 may be operationally coupled to the bridge portion 115c of the body 110. In an exemplary embodiment, the bridge portion 115c snap fits into the groove 135d of the wing 130. The bridge portion 115c of the body 110 acts as a fulcrum for the wing 130. The operational coupling between the groove 135d and the bridge portion 115c provides stability to the wing 130.
[047] The first member 135a, second member 135b and the groove 135d at least partially enable the wing 130 to pivot in a to-and-fro motion. The to-and-fro motion of the wings 130 with respect to the body 110 helps to align the device 100 with a central axis of the bone canal or the like.
[048] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:We claim,
1. A device (100) comprising:
a. a proximal end (100a) and a distal end (100b);
b. a body (110) including:
i. a cavity (111) extending axially from the proximal end (100a) towards the distal end (100b), the cavity (111) configured to receive at least a portion of a stem-like prosthesis (10), and
ii. at least one coupling section (115) provided in an outer surface of the body (110) and towards the distal end (100b); and
c. at least one wing (130) having a distal portion (135);
wherein, the distal portion (135) of the wing (130) is removably coupled to the coupling section (115) of the body (110) thereby enabling the wing (130) to pivot in a to-and-fro motion with respect to the body (110).
2. The device (100) as claimed in claim 1, wherein the coupling section (115) includes:
a. a first window (115a) disposed towards a distal portion of the body (110);
b. a second window (115b) disposed distal to the first window (115a) and axially aligned with the first window (115a); and
c. a bridge portion (115c) separating the first window (115a) and the second window (115b), the bridge portion (115c) having a predefined length.
3. The device (100) as claimed in claim 1, the wing (130) further includes:
a. a proximal portion (131) disposed towards the proximal end (100a), and
b. a wing body (133) disposed distal to the proximal portion (131).
4. The device (100) as claimed in claim 1, wherein the distal portion (135) of the wing (130) define a C-shaped section including:
a. a first member (135a) disposed towards the distal end (100b);
b. a second member (135b) being distal to the first member (135a);
c. a strip (135c) coupling the first member (135a) to the second member (135b); and
d. a groove (135d) disposed between the first member (135a) and the second member (135b).
5. The device (100) as claimed in claims 2 and 4, wherein:
a. the first member (135a) of the wing (130) is removably coupled to the first window (115a) of the body (110),
b. the second member (135b) of the wing (130) is removably coupled to the second window (115b) of the body (110), and
c. the groove (135d) of the wing (130) is removably coupled to the bridge portion (115c) of the body (110).
6. The device (100) as claimed in claim 1, wherein the body (110) and the wing (130) are made of a biocompatible material including at least one of polymethyl methacrylate (PMMA), ultra-high-molecular-weight polyethylene (UHMWPE), or polyether ether ketone (PEEK).
7. The device (100) as claimed in claim 1, wherein the cavity (111) is tapered from the proximal end (100a) to the distal end (100b).
8. The device (100) as claimed in claim 1, wherein the body (110) includes a rounded edge (113) at the distal end (100b).
9. The device (100) as claimed in claim 1, wherein body (110) is tapered towards the distal end (100b).
10. The device (100) as claimed in claim 1, wherein the first window (115a) and/or second window (115b) is defined by a plurality of chamfered surfaces.
11. The device (100) as claimed in claim 1, wherein at least one inclined surface (115b1) is disposed in the cavity (111) and adjacent to the second window (115b).
12. The device (100) as claimed in claim 1, wherein a proximal portion (131) of the wing (130) may extend beyond a proximal edge of the body (110).