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

TITLE OF THE INVENTION
MITRAL ANNULUS REMODELING IMPLANT

APPLICANT:
Meril Corporation (I) Private Limited, an Indian company of the address Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India.

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

FIELD OF INVENTION
[1] The present disclosure relates to a medical implant. More particularly, the present disclosure relates to a mitral annulus remodeling implant.
BACKGROUND OF INVENTION
[2] Mitral regurgitation is one of the most common conditions of a valvular heart disease causing malfunctioning of papillary muscles (shown as ‘A’ in Fig. 1), leaflet prolapse and/or stretching of the mitral valve annulus, resulting in abnormal backflow of blood from the left ventricle to the left atrium. In this condition, the blood backflow from the mitral valve to the aortic valve is uncontrolled due to which excessive blood flows back into the left atrium. This is referred to as mitral regurgitation.
[3] Most commonly, some of the prior techniques used for treating mitral regurgitation include stitching the portions of the native mitral valve leaflets directly to each other, or replacing the valve or repairing the valve. The repairing process includes leaflet and annulus remodeling.
[4] In recent years, various techniques have been introduced for repairing the defective heart valves to treat mitral regurgitation which are minimally invasive and do not require surgeries. These techniques involve deployment of implants into the great cardiac vein ‘A’ or the coronary sinus for remodeling the mitral annulus.
[5] Conventionally available implants may lack structural integrity and/or configuration needed to change the shape of the mitral annulus. The design of the conventional implant may also cause damage to the inner walls of the coronary sinus. Also due to a compact region inside the vessel, it becomes difficult for the surgeon to disengage the implant.
[6] Thus, there arises a need for an implant that overcomes the problems associated with the conventional implants.
SUMMARY OF INVENTION
[7] 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.
[8] The present disclosure relates to an implant. The implant includes a proximal portion and a distal portion. The proximal portion includes a first cone extending from the first end to the second end of the proximal portion, the cone has a tapering profile with at least one increasing or decreasing taper from the first end towards the second end. The distal portion includes a second cone which extends from a first end to a second end of the distal portion. The second cone has a tapering profile with at least one increasing or decreasing taper from the first end towards the second end. An undulating connecting portion is provided for connecting the proximal portion and the distal portion. The first end of the proximal portion defines an end point having a screw mechanism with external threads provided on the outer periphery of the end point to connect a delivery wire to facilitate easy detachment of the implant from the delivery wire and retrieval of the implant post deployment.
BRIEF DESCRIPTION OF DRAWINGS
[9] 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.
[10] Fig. 1. Depicts a condition of mitral regurgitation, according to an embodiment of the present disclosure.
[11] Fig. 2A.depicts an implant 200, according to an embodiment of the present disclosure.
[12] Fig. 2B.depicts a side view of the implant 200, according to an embodiment of the present disclosure.
[13] Fig. 2C.depicts a screw mechanism of the implant 200, according to an embodiment of the present disclosure.
[14] Fig. 3A.depicts an undeployed view of the implant 200, according to an embodiment of the present disclosure.
[15] Fig. 3B. depicts a deployed view of the implant 200, according to an embodiment of the present disclosure.
[16] Fig. 4A. depicts an implant 400, according to an embodiment of the present disclosure.
[17] Fig. 4B. depicts a side view of the implant 400,according to an embodiment of the present disclosure.
[18] Fig. 5A. depicts an undeployed view of the implant 400, according to an embodiment of the present disclosure.
[19] Fig. 5B depicts a deployed view of the implant 400, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[20] Prior to describing the invention 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.
[21] 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.
[22] 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.
[23] 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.
[24] The present disclosure relates to an implant. In an embodiment, the implant is placed in the great cardiac vein of the heart to treat conditions such as mitral regurgitation. The implant includes at least two cones in the shape of a hooper, conical, double inverted cones, hourglass, for at least a portion of the length of the implant. The cones could be a conical coils or it could be a solid conical body. In one embodiment, the cone is a conical coil. In another embodiment, the cone is a solid conical body made of a compressible material. The implant may be delivered to a targeted site via a transcatheter technique.
[25] Fig. 2A depicts an implant 200 in accordance with an embodiment of the present invention. The implant 200 has a proximal end 200a and a distal end 200b. The implant 200may be manufactured using a single wire200n or different wire segments welded together. The wire may have a pre-defined diameter ranging from 0.25mm to 0.65mm. In an embodiment, the wire has a diameter of 0.40mm.
[26] The implant200 may be made of a self-expandable material such as without limitation Nitinol, specialized stainless steel, polyurethane, foam, foam silicon, etc. In an embodiment, the implant200 is made up of Nitinol.
[27] The implant 200 includes three portions, a proximal portion 201, a distal portion 203 and a connecting portion 205.The implant 200 has a central axis defined by the proximal portion 201, the distal portion 203 and the connecting portion 205. The proximal portion 201 is situated towards the proximal end 200a and the distal portion 203 is situated towards the distal end 200b of the implant 200. The connecting portion 205 is provided to establish a connection between the proximal portion 201 and the distal portion 203.
[28] The proximal portion 201 has a first end201a and a second end 201b.The proximal portion 201includes a cone extending from the first end 201a to the second end 201b of the proximal portion 201.The cone of the proximal portion 201 may have a tapering profile with at least one increasing or decreasing taper from the first end 201a towards the second end 201b. In an embodiment, the proximal portion 201 has a continuous decreasing taper from the first end 201a towards the second end 201b. The cone may be arranged in shapes such as without limitation square, oval, circular, etc. In an embodiment, the cone of the proximal portion 201depicts a single conical coil as shown in Figs. 2A and 2B. The coil may include multiple spirals with a minimum of 7 spirals. The coil of the proximal portion 201 may include a pre-defined pitch ‘P’. The pitch ‘P’ of the proximal portion 201of the coil may range from 1 mm to5mm. In an embodiment, the pitch ‘P’ is 3mm.
[29] The proximal portion 201 may further define an end point 201c situated at the first end 201a. The end point 201c may be an extension of the wire at the proximal end 200a of the proximal portion 201. The end point 201c is provided with a detachment mechanism to detach the implant 200 from the sheath (as shown in Fig. 2A – 2C). In an embodiment, the end point 201c is provided with external threads on the outer periphery. In an embodiment, the end point 201c is provided with a screw mechanism. During the implantation procedure, the threads are connected to a delivery wire. Once the implant 200 is reached at its targeted location the delivery wire is rotated in a counter clockwise to disengage the implant 200 from the delivery wire. The separation of both the components is achieved through a twisting mechanism. The screw mechanism of the end point 201c facilitates easier detachment of implant 200, and simplifies retrieval after deployment.
[30] The proximal portion 201 may have a pre-defined length ranging from 20mm to30mm. In an embodiment, the proximal portion 201 has a length of 25 mm. The proximal portion 201 serves to exert a force on the inner wall of the coronary sinus. The proximal portion 201 helps in easy detachment and retrieval of the implant 200.
[31] The implant 200includes a distal portion 203 situated at the distal end 200b of the implant 200. The distal portion 203 has a first end 203a and a second end 203b. The distal portion 203includes a cone extending from the first end 203a to the second end 203b of the distal portion 203.The cone of the distal portion 203 may have a tapering profile with at least one increasing or decreasing taper from the first end 203a towards the second end 203b. In an embodiment, the distal portion 203 has a continuous decreasing taper from the second end 203b towards the first end 203a. The cone may be arranged in shapes such as without limitation square, oval, circular, etc. In an embodiment, the cone of the distal portion 203is arranged in a conical coil shape as shown in Fig. 2A and 2B. The coil of the distal portion 203 may include a pre-defined pitch ‘P’. The pitch ‘P’ of the distal portion 203 range from 1mm to 5mm. In an embodiment, the pitch “P” is 3mm.
[32] The distal portion 203 may have a pre-defined length ranging from 15mm to 25mm. In an embodiment, the distal portion 203 has a length of 20 mm.
[33] The distal portion 203 may further define an end point 203c situated at the second end 203b (as shown in Fig. 2A – 2C). The end point 203c may be smooth or rounded to avoid injury to the native tissues. The distal portion 203 serves to exert force on the inner wall of the great cardiac vein and used as an anchor of the implant 200.
[34] The dimensions (length and diameter) of the proximal portion 201 may vary from the dimensions of the distal portion 203. In an embodiment, the dimensions of the distal portion 203 is comparatively smaller than the dimensions of the proximal portion 201. Alternately, dimensions (length and diameter) of the proximal portion 201 and the distal portion 203 may be same.
[35] The proximal portion 201and the distal portion 203 of the implant 200are connected via the connecting portion205 (as shown in Fig. 2A and 2B). The connecting portion205 has a first end 205a and a second end 205b. The connecting portion 205 is situated between the proximal portion 201 and the distal portion 203 to establish a connection therebetween such that the first end205a of the connecting portion205 is connected to the second end201b of the proximal portion 201 and the second end205b of the connecting portion205 is connected to the first end203a of the distal portion 203. The connecting portion 205generally has a substantially undulating structure. The structure of the connecting portion 205 enhances grip and provides stability and strength to the proximal portion 201 and the distal portion 203.
[36] The connecting portion 205 may have shapes such as without limitation sine, spiral, wave, curve, bent, helix, etc. In an embodiment, the connecting portion 205 has a helix shape (shown in Fig. 2A) wound around the central axis of the implant 200.The helix shape of the connecting portion 205 is provided to surround the inner wall of the great cardiac vein and the coronary sinus. The connecting portion205 may have a pre-defined length ranging from 30mm to 40mm. In an embodiment, the connecting portion205 has a length of 35 mm.
[37] Figs. 3A and 3B depict the deployment of the implant 200 inside the body. ‘A’ indicates the great cardiac vein and ‘B’ indicates the coronary sinus. During a medical procedure, the implant 200 may be delivered to the targeted site via a minimally invasive procedure such as a transcatheter technique. The implant 200 being made of a self-expandable material is encapsulated inside a sheath ‘C’ for delivery inside a lumen, say the great cardiac vein. The implant 200 is pre-attached with a delivery wire ‘D’ and loaded on a loader (not shown). The loader is further attached to the proximal end of the sheath ‘C’. During implantation procedure, a guidewire (not shown) is reached to the targeted site and placed within the great cardiac vein. Once the guidewire is positioned, the sheath ‘C’ enclosing the implant, is mounted on the guidewire along with a dilator. During the procedure of implantation, the distal end of a delivery catheter is advanced inside the body. The sheath ‘C’ is first positioned inside the great cardiac vein ‘A’. After placement, the delivery wire ‘D’ is pushed and the implant 200 is pushed outside from the loader to the sheath ‘C’ which causes the implant 200 to be exposed and expand before being positioned inside the great cardiac vein ‘A’ from the distal end of the sheath ‘C’. The remaining portion of the implant 200 is then compressed and ultimately deployed inside the coronary sinus. The distal portion of the implant 200 is delivered first inside the great cardiac vein ‘A’ followed by the connecting portion and the proximal portion of the implant200. Once the implant 200 is delivered in the target site, it is detached from the end point 201c and the sheath ‘C’ along with the delivery wire ‘D’ is pulled out from the coronary sinus ‘B’. Post deployment of the implant 200 at the implantation site, the implant 200exerts a force on the inner wall of the great cardiac vein causing the valve to attain its original shape.
[38] Figs 2A-2B depict one embodiment of the implant 200 wherein the shape of proximal portion 201 and distal portion 203 includes a single cone made of a tapered coil, however, numerous other variations are possible. One such variation is depicted in Figs 4A – 4B.
[39] Fig. 4A depicts an implant 400. The implant 400 has a proximal end 400a and a distal end 400b. Between the proximal end 400a and the distal end 400b, three portions of the implant 400, a proximal portion 401, a distal portion 403 and a connecting portion 405 are defined. The implant 400 may be manufactured using a single wire or different wire segments welded together.
[40] The implant 400 differs from the implant 200 only with respect to the proximal portion 401 and the distal portion 403. Therefore, details of the connecting portion 405 can be referred from the details of the connecting portion 205 and not repeated for sake of brevity.
[41] The proximal portion 401 has a first end 401a and a second end 401b. The proximal portion 401 includes a cone extending from the first end 401a to the second end 401b. The cone of the proximal portion 401 includes a continuous decreasing taper from the first end 401a till a pre-defined length of the proximal portion 401followed by a continuous increasing taper from the pre-defined length towards the second end 401b of the proximal portion 401. That is, the proximal portion 401 can be shaped to resemble two conical coils connected at their tapered (namely, narrowed) ends. The pre-defined length of the proximal portion 401 is 25mm while the total length of the proximal portion 401 is also25mm. The pitch ‘P’ of the coil may range from 1mm to 3mm.
[42] The proximal portion 401 may further define an end point 401c situated at the first end 401a. The details of the end point 401c are similar to the end point 201c and can be referred therefrom.
[43] The distal portion 403 of the implant 400 is situated at the distal end 400b of the implant 400. The distal portion 403 has a first end 403a and a second end 403b. The distal portion 403 includes a cone extending from the first end 403a to the second end 403b of the distal portion 403. Similar to the proximal portion 401, the distal portion 403 includes a continuous decreasing taper from the first end 403a till a pre-defined length of the distal portion 403followed by a continuous increasing taper from the pre-defined length towards the second end 403b of the distal portion 403.That is, the distal portion 403 can be shaped to resemble two conical coils connected at their tapered (namely, narrowed) ends. The pre-defined length of the distal portion 403 is 20mm while the total length of the distal portion 403 is 20mm. The pitch ‘P’ of the coil may range from 1mm to 3mm.
[44] The dimensions of the proximal portion 401 may vary from the dimensions of the distal portion 403. In an embodiment, the dimensions of the distal portion 403are comparatively smaller than the dimensions of the proximal portion 401.
[45] The placement of the implant 400 may be as similar as described above with respect to the placement of the implant 200, hence, is not been repeated for the sake of brevity.
[46] 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. An implant (200, 400) comprising:
a. a proximal portion (201, 401)including a first cone extending from a first end (201a, 401a) to a second end (201b, 401b) of the proximal portion (201, 401), the first cone having a tapering profile with at least one increasing or decreasing taper from the first end (201a, 401a) towards the second end (201b, 401b);
b. a distal portion (203, 403)including a second cone extending from a first end (203a, 403a) to a second end (203b, 403b) of the distal portion (203, 403), the second cone having a tapering profile with at least one increasing or decreasing taper from the first end (203a, 403a) towards the second end (203b, 403b); and
c. an undulating connecting portion (205, 405) for connecting the proximal portion (201, 401) and the distal portion (203, 403);
wherein the first end (201a, 401a) of the proximal portion (201, 401)defines an end point (201c, 401c) having a screw mechanism with external threads provided on the outer periphery of the end point (201c, 401c) to connect a delivery wire to facilitate easy detachment of the implant (200, 400) from the delivery wire and retrieval of the implant (200, 400) post deployment.
2. The implant (200, 400) as claimed in claim 1, wherein the cone has a hooper, conical, double inverted cones and hourglass shape.
3. The implant (200) as claimed in claim 1, wherein the proximal portion (201) and the distal portion (203) include a single conical coil.
4. The implant (200) as claimed in claim 1, wherein the first coil and the second coil include pre-defined pitch ‘P’ ranging from 1mm to 5 mm.
5. The implant (400) as claimed in claim 1, wherein the first cone of the proximal portion (401) includes a continuous decreasing taper from the first end (401a) till a pre-defined length of the proximal portion (401) followed by a continuous increasing taper from the pre-defined length towards the second end (401b) of the proximal portion(401).
6. The implant (400) as claimed in claim 1, wherein the second cone of the distal portion (403) includes a continuous decreasing taper from the first end (403a) till a pre-defined length of the distal portion (403) followed by a continuous increasing taper from the pre-defined length towards the second end (403b) of the distal portion (403).
7. The implant (400) as claimed in claim 1, wherein the proximal portion (401) and the distal portion (403) resemble two conical coils connected at their tapered ends.
8. The implant (200, 400) as claimed in claim 1, wherein the undulating connecting element (205, 405) includes a helix shape wound around the central axis of the implant (200, 400).
9. The implant (200, 400) as claimed in claim 1, wherein the dimensions of the distal portion (203, 403) are comparatively smaller than the dimensions of the proximal portion (201, 401).