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:
ANNULOPASTY DEVICE
2. 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 the manner in which it is to be performed:

FIELD OF INVENTION
[001] The present disclosure relates to a bio-medical device. More specifically, the present disclosure relates to an annuloplasty device.
BACKGROUND OF INVENTION
[002] The mitral valve, ensures that blood flows from the left atrium to the left ventricle and not the other way round. The mitral valve is provided with leaflets that close by at least partially overlapping on each other thereby, preventing any back flow of blood from the left ventricle to the left atrium. However, with age, the leaflets of the mitral valve do not close properly due to dilation of the mitral valve annulus. The dilated annulus of the mitral valve allows blood to leak back from the left ventricle to the left atrium. This condition of the mitral valve is called mitral valve regurgitation.
[003] Apart from age, other common causes of mitral valve regurgitation include medical conditions such as endocarditis, rheumatic fever, valve prolapse, abnormality of heart muscles, damaged tissue cord(s) or combinations thereof. A patient suffering from mitral regurgitation may have symptoms such as shortness of breath, pulmonary edema, orthopnoea, paroxysmal nocturnal dyspnoea, and/or congestive heart failure.
[004] A patient suffering from mitral valve regurgitation may be prescribed one or more treatment courses depending on the severity of the condition. In mild cases, the patients may be prescribed to undergo monitoring along with medication. In severe cases, a surgery may be suggested to fix or replace the mitral valve.
[005] Mitral valve annuloplasty is a surgical procedure to treat mitral valve regurgitation by replacing or repairing the mitral valve. Generally, the mitral annuloplasty procedure includes at least one of an open-heart surgery or a percutaneous approach. The open-heart surgery is an invasive procedure performed on a patient to constrict the mitral valve by replacing, repairing, or resizing the mitral valve annulus. The percutaneous approach is a minimally invasive procedure in which a catheter is percutaneously inserted through the vasculature to the heart and the mitral valve annulus is constricted using an implant coupled to a distal end of the catheter.
[006] Few of the conventionally available implants, used for minimally invasive mitral valve annuloplasty, may include multiple legs that anchor at multiple points around the annulus of the mitral valve. These implants require an actuating device for individually anchoring the legs of the implant around the annulus of the mitral valve. Further, the actuating device is required for radially collapsing the legs of the implant to constrict the annulus of the mitral valve. Thus, individually actuating each of the legs of the implant for anchorage and then actuating the legs of the implant to radially collapse increases the overall time of the surgical procedure, is cumbersome to follow through for the medical practitioner and results in prolonged trauma for the patient.
[007] Hence, there arises a need for a device that overcomes these and other shortcomings related to actuating devices known in the art.
SUMMARY OF INVENTION
[008] 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.
[009] The present disclosure relates to a device for deploying an implant. The device includes at least two triggering mechanisms, an anchoring mechanism, and an actuating mechanism. The at least two triggering mechanisms includes a first triggering mechanism and a second triggering mechanism. The anchoring mechanism includes a plurality of anchoring shafts operationally coupled to the first triggering mechanism. Each of the anchoring shaft includes a proximal end and a distal end. The distal end of the anchoring shaft is removably coupled to an implant. The actuating mechanism includes at least one actuating shaft operationally coupled to the second triggering mechanism. The actuating shaft includes a proximal end and a distal end. The distal end of the actuating shaft is removably coupled to the implant. The at least two triggering mechanisms are configured to trigger one of the anchoring mechanism and the actuating mechanism at a time to anchor and radially collapse the implant, respectively. The first triggering mechanism configures all the anchoring shafts simultaneously to anchor the implant.
BRIEF DESCRIPTION OF DRAWINGS
[0010] 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.
[0011] Fig. 1 depicts an annuloplasty device 100 and an implant 10, in accordance with an embodiment of the present disclosure.
[0012] Fig. 2a depicts an isometric view of the annuloplasty device 100, in accordance with an embodiment of the present disclosure.
[0013] Fig. 2b depicts a lateral cross-sectional view of a sheath 103 of the annuloplasty device 100, in accordance with an embodiment of the present disclosure
[0014] Fig. 3a depicts a longitudinal cross-sectional view of the annuloplasty device 100, in accordance with an embodiment of the present disclosure.
[0015] Fig. 3b depicts an enlarged view of a second gear 117 of the annuloplasty device 100, in accordance with an embodiment of the present disclosure.
[0016] Fig. 3c depicts a distal view of an actuating head 131 of the annuloplasty device 100, in accordance with an embodiment of the present disclosure.
[0017] Fig. 3d depicts a distal view of an anchoring head 111 of the annuloplasty device 100, in accordance with an embodiment of the present disclosure.
[0018] Fig. 4a depicts a first position of an introducer 151 with respect to the annuloplasty device 100, in accordance with an embodiment of the present disclosure.
[0019] Fig. 4b depicts a second position of the introducer 151 with respect to the annuloplasty device 100, in accordance with an embodiment of the present disclosure.
[0020] Fig. 5 depicts an exemplary method 500 to deploy the implant 10 using the annuloplasty device 100, in accordance with an embodiment of the present disclosure.
[0021] Fig. 5a depicts a radially expanded (or unactuated) configuration of the implant 10 attached to the annuloplasty device 100, in accordance with an embodiment of the present disclosure.
[0022] Fig. 5b depicts a radially collapsed (or actuated) configuration of the implant 10 attached to the annuloplasty device 100, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF ACCOMPANYING DRAWINGS
[0023] 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.
[0024] 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.
[0025] 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.
[0026] 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.
[0027] The present disclosure relates to an annuloplasty device (or device) used to deploy an implant. The implant may be used in surgical procedures including, but not limited to, mitral annuloplasty, structural heart, and the like.
[0028] The device of the present disclosure helps to deploy the implant at for example, the mitral valve of the heart. The implant is provided with a plurality of legs. The device helps to anchor the legs of the implant on the annulus of the mitral valve (or valve anulus) and thereafter, radially collapse the legs of the implant simultaneously to constrict the valve annulus. Constricting the valve annulus via the implant increases the overlap of the leaflets of the mitral valve and reduces valve regurgitation.
[0029] The device of the present disclosure includes an anchoring mechanism for simultaneously anchoring all the legs of the implant at the valve annulus. The device further includes an actuation mechanism for radially collapsing the legs of the implant to constrict the valve annulus. Having both mechanisms, the anchoring mechanism as well as the actuating mechanism, the device reduces the time required to complete the surgical procedure of deploying the implant at the valve annulus and constricting the valve annulus to reduce valve regurgitation. The device also makes the surgical procedure very easy to follow through, for the medical practitioner.
[0030] The device includes at least a first triggering mechanism and a second triggering mechanism to control the anchoring mechanism and the actuation mechanism of the device, respectively. For example, the device includes two knobs namely an anchoring knob (i.e., the first triggering mechanism) and an actuating knob (i.e., the second triggering mechanism). The anchoring knob is used to control the anchoring mechanism of the device, thus facilitating anchorage of the legs of the implant at the valve annulus. The actuating knob is used to control the actuation mechanism of the device, thus facilitating the legs of the implant to be radially collapsed to constrict the valve annulus.
[0031] The device is provided with an introducer that is movably disposed around the implant. The introducer helps to constrain the implant in a radially collapsed state to allow the implant to be percutaneously advanced to the valve anulus and positioned for deployment. Before deploying the implant, the introducer is retracted from over the implant causing the implant to self-expand compared to the radially collapsed state of the implant within the introducer. The introducer also allows to re-constrain the implant to reposition the device and/or the implant, if desired by the medical practitioner.
[0032] Now referring to the figures, Fig. 1 depicts an assembly of a device 100 and implant 10 while Fig. 2a depicts an exemplary detailed view of the device 100. The device 100 is defined by at least two opposite ends. The two ends include a proximal end and a distal end. The annuloplasty device 100 includes at least a handle 101, a sheath 103, a plurality of anchoring shafts 110, and an actuating shaft 130. The handle 101 is disposed at the proximal end. The sheath 103 is disposed adjacent to the distal end of the handle 101, extending away from the handle 101. The anchoring shafts 110 and the actuating shaft 130 extend from the proximal portion of the device to the distal portion and are at least partially disposed within the handle 101 and the sheath 103.
[0033] The implant 10 is removably coupled to the distal end of the device 100. The implant 10 in accordance with an embodiment of the present disclosure has a plurality of legs 13 and an actuator member 11 operationally coupled to the legs 13. The legs 13 of the implant 10 may be radially collapsed by constraining within a sheath or the like. Accordingly, when the constrain is removed from around the legs 13 of the implant 10, the implant may self-expand. Each of the legs 13 of the implant 10 may include an anchoring member 13a towards its distal end. The anchoring members 13a are configured to anchor the implant 10 at an implantation site, i.e., a valve annulus. The actuator member 11 of the implant 10 is used to radially collapse or expand the legs (and the anchoring members 13a along with the valve annulus) of the implant 10. The implant 10 is removably coupled to the device 100 via the plurality of anchoring shafts 110 and the actuating shaft 130.
[0034] Each of the legs (having the anchoring member) of the implant 10 is removably coupled to a respective anchoring shaft 110 of the device 100. The anchoring shafts 110 of the device 100 simultaneously drives respective anchoring members of the legs for anchoring the implant 10 at the valve annulus.
[0035] The actuator of the implant 10 is removably coupled to the actuating shaft 130 of the device 100. The actuating shaft 130 of the device 100 drives the actuator of the implant 10 thereby facilitating radial collapse and/or expansion of the legs of the implant 10.
[0036] The distal end of the handle 101 is either fixedly or removably coupled to the proximal end of the sheath 103 via at least one of UV bonding, medical adhesive, etc. In an exemplary embodiment, the handle 101 is fixedly coupled to the sheath 103 via UV bonding. The handle 101 of the device 100 may be a hollow longitudinal structure with a pre-defined shape/cross-section including, but not limited to oval, rectangle, square, drop shape, and the like. In an exemplary embodiment, the handle 101 of the device 100 has a drop shape. The handle 101 may have a predefined length ranging from 150 mm to 350 mm. In an exemplary embodiment, the length of the handle 101 is 200 mm. The handle 101 may be made up of one or more materials including, but not limited to, Acrylonitrile butadiene styrene (ABS), photo polymer, High Density Polyethylene (HDPE), and the like. In an exemplary embodiment, the handle 101 is made of ABS. The handle 101 helps the medical practitioner to hold and use the device 100 to deploy the implant 10.
[0037] An outer surface of the handle 101 is provided with at least two openings 101a, 101b for seating respective knobs (explained later). The knobs in an exemplary embodiment control the anchoring shafts 110 and the actuating shafts 130 respectively. The shape of the openings 101a, 101b corresponds to the shape of the knobs, which may include rectangle, square, oval, triangle or a combination thereof. In an exemplary embodiment, as shown in Fig. 2, the shape of the openings 101b is rectangle. The openings 101b allows a medical practitioner to interact with a portion of the knobs disposed at least partially within the handle 101.
[0038] The handle 101 houses a plurality of components of the device 100 including, but not limited to, a first gear 115, a second gear 117, a plurality of pinions 119, and at least two triggering mechanisms, shown in Fig. 3a. The at least two triggering mechanisms include a first triggering mechanism to control the anchoring mechanism and a second triggering mechanism to control the actuation mechanism of the device 100. In an exemplary embodiment, the first triggering mechanism includes an anchoring knob 113 and the second triggering mechanism includes an actuating knob 133. The anchoring knob 113 is used to impart rotational motion to the anchoring shaft 110. The actuating knob 133 is used to impart rotational motion to the actuating shaft 130. Other functionally equivalent triggering mechanism to control the anchoring mechanism and the actuation mechanism of the device 100, such as, rollers, sliders, pushing mechanism, pulling mechanism, or the like are within the scope of the teachings of the present disclosure.
[0039] The first gear 115, the second gear 117, the anchoring knob 113, the plurality of pinions 119, and the actuating knob 133 are operationally coupled to the handle 101 such that they are allowed to freely rotate with respect to the handle 101. The handle 101 also at least partially houses the anchoring shafts 110 and the actuating shaft 130.
[0040] The anchoring knob 113 at least partially protrudes out of the opening 101a and is operationally coupled to the proximal end of the anchoring shaft (110). The anchoring knob 113 is used to control the plurality of anchoring shafts 110 via the first gear 115, the second gear 117 and the plurality of pinions 119. The actuating knob 133 at least partially protrudes out of the opening 101b. The actuating knob 133 is used to control the actuating shaft 130. Although the present disclosure describes the control of the anchoring shafts 110 via the first gear 115, the second gear 117 and the plurality of pinions 119, other functionally equivalent structures/mechanisms are within the scope of the teachings of the present disclosure.
[0041] The sheath 103 at least partially encloses the anchoring shafts 110 and the actuating shaft 130. The sheath 103 may be made up of one or more materials including, but not limited to, pebax, nylon, polyurethane, and the like. In an exemplary embodiment, the sheath 103 is made of pebax. In an embodiment, the sheath 103 has a cylindrical shape. Other shapes of the sheath are also within the scope of the teachings of the present disclosure. The sheath 103 of the annuloplasty device 100 may have a pre-defined diameter ranging from 14 Fr to 28 Fr. The sheath 103 may have a pre-defined length ranging from 1000 mm to 1250 mm. In an exemplary embodiment, the length and diameter of the sheath 103 is 1100 mm and 24 Fr, respectively.
[0042] In an exemplary embodiment, as shown in Fig. 2b, the sheath 103 is solid defining a plurality of conduits. For example, the sheath 103 includes a plurality of first conduits 103a corresponding to the number of anchoring shafts 110 and a second conduit 103b corresponding to the actuating shaft 130. The first conduits 103a and the second conduit 103b of the sheath 103 extend from the proximal end to the distal end of the sheath 103.
[0043] In an alternate embodiment, not shown, the sheath 103 is completely hollow thereby defining a single conduit for at least partially housing the anchoring shafts 110 and the actuating shaft 130.
[0044] In yet another embodiment, not shown, the sheath 103 includes the first conduits 103a and the second conduit 103b extending along at least a portion of the sheath 103 and a single conduit extending along the remaining portion of the sheath 103.
[0045] In the depicted embodiment of Fig. 2b, the second conduit 103b is disposed at a center of the sheath 103. The first conduits 103a are disposed circumferentially and equidistantly around the second conduit 103b of the sheath 103. In an embodiment, the first conduits 103a and the second conduit 103b of the sheath 103 have a circular cross section. Other cross-sectional shape of the conduits 103a, 103b are within the scope of the teachings of the present disclosure. Further, Fig. 2b depicts an exemplary relative arrangement of the first conduits 103a and the second conduit 103b. Other functionally equivalent arrangements of the conduits based on the position of the actuator and/or the legs of the implant 10 are within the scope of the teachings of the present disclosure.
[0046] Each of the first conduits 103a at least partially encloses a respective anchoring shaft 110. The first conduits 103a may have a pre-defined inner diameter, corresponding to the diameter of the anchoring shafts 110, ranging from 1 mm to 3 mm. In an exemplary embodiment, the inner diameter of the first conduits 103a is 1.5 mm.
[0047] The second conduit 103b at least partially receives the actuating shaft 130. The inner diameter of the second conduit 103b corresponds to the diameter of the actuating shaft 130, ranging from 2 mm to 5 mm. In an exemplary embodiment, the inner diameter of the second conduit 103b is 3.5 mm.
[0048] The number of the anchoring shafts 110 may correspond to the number of anchoring members 13a of the implant 10. In an exemplary embodiment, there are four anchoring shafts 110, each extending from the handle 101 and through a respective first conduit 103a of the sheath 103. The anchoring shafts 110 may either be flexible or rigid. In an exemplary embodiment, the anchoring shafts 110 are flexible. All the anchoring shafts 110 are structurally and functionally identical. In an exemplary embodiment, the proximal end of each of the anchoring shafts 110 is coupled to a respective pinion 119 disposed within the handle 101(described later). The anchoring shaft 110 is coupled to the pinion 119 via at least one of laser welding, soldering, brazing, welding, and so forth. In an embodiment, the anchoring shaft 110 is coupled to the pinion 119 using laser welding.
[0049] The length of the anchoring shafts 110 may range from 1200 mm to 1350 mm. A cross-section of the anchoring shaft 110 is at least one of circular, oval, square, triangle, pentagonal, heptagonal, etc. In an exemplary embodiment, the length of the anchoring shaft having a circular cross-section is 1300 mm. The anchoring shaft 110 may be made of one or more materials including, but not limited to, stainless steel, nickel titanium alloy (nitinol, Ni-Ti), titanium, cobalt-chromium (Co-Cr), and the like. In an embodiment, the anchoring shaft 110 is made up of stainless steel.
[0050] As shown in Fig. 3a, an anchoring head 111 is provided at the distal end of the anchoring shaft 110. The anchoring head 111 may be either aligned with the respective anchoring shaft 110 or may be at an offset from the respective anchoring shaft 110 depending upon the required amount of radial collapse of the leg 13 of the implant 10. The anchoring head 111 may have a first cavity 111a (as shown in Fig. 3d) configured to receive at least one of the anchoring members 13a of the implant 10. The shape of the first cavity 111a of the anchoring head 111 corresponds to the shape of the anchoring member 13a of the implant 10. The first cavity 111a may have a shape including, but not limited to, pentagon, hexagon, octagon, triangle, square and the like. In an exemplary embodiment, as shown in Fig. 3d, the first cavity 111a is pentagon shaped.
[0051] The anchoring shaft 110 (along with the anchoring head 111) is configured to rotate upon rotation of the anchoring knob 113 thereby at least rotating the anchoring member 13a of the implant 10. The anchoring members 13a, upon rotation, pierce the tissue of the valve annulus and anchor the implant 10 at the valve annulus.
[0052] The anchoring knob 113 is disposed within the handle 101, at least protruding out of the openings 101a of the handle 101. The anchoring knob 113 may be made of one or more materials including but not limited to stainless steel, ABS, photo polymer, nitinol, titanium, and the like. In an exemplary embodiment, not shown, an outer surface of the anchoring knob 113 is provided with a plurality of ridges/grooves for the medical practitioner to easily and controllably rotate the anchoring knob 113.
[0053] The first gear 115 is disposed distal to the anchoring knob 113 and coupled thereto via an elongate member 115a. In an exemplary embodiment, as shown in Fig. 3a, the first gear 115 is disposed concentric to the anchoring knob 113. The elongate member 115a helps to transfer the rotational motion of the anchoring knob 113 (imparted by the medical practitioner) to the first gear 115. The elongate member 115a is coupled to the anchoring knob 113 and the first gear by at least one of welding, laser welding, soldering, brazing, and so forth. In an exemplary embodiment, the elongate member 115a is coupled to the anchoring knob 113 and the first gear 115 via laser welding.
[0054] The diameter of the first gear 115 may range from 7 mm to 12 mm. In an exemplary embodiment, the first gear 115 is a spur gear having a diameter of 10 mm. The first gear 115 is configured to be operationally coupled to the second gear 117 and transfers the rotational motion of the anchoring knob 113 to the second gear 117. Although the first gear 115 is described with the example of the spur gear, other functionally equivalent gears are within the scope of the teachings of the present disclosure.
[0055] At least a portion of the second gear 117 is disposed close to the first gear 115 within the handle 101. In an exemplary embodiment, as shown in Fig. 3b, the second gear 117 is a double spur gear, having two sections namely a driven gear 117a and a driving gear 117b. The two sections of the second gear 117 are concentric and are connected through a hollow shaft 117c (as shown in Fig. 3b). The hollow shaft 117c may define a through lumen extending across the entire length of the second gear 117. The lumen of the hollow shaft 117c (and the second gear 117) is configured to at least partially receive the actuating shaft 130.
[0056] The driven gear 117a may have a pre-defined diameter ranging from 6 mm to 10 mm. The driving gear 117b may have a pre-defined diameter ranging from 7 mm to 13 mm. In an exemplary embodiment, the diameter of the driven gear 117a and the driving gear 117b is 8 mm and 11 mm, respectively. The hollow shaft 117c (and the second gear 117) may have a pre-defined length ranging from 12 mm to 18 mm. In an exemplary embodiment, the length of the hollow shaft 117c is 15 mm. The diameter of the hollow shaft 117c corresponds to the diameter of the actuating shaft 130. The driven gear 117a is operationally coupled to the first gear 115, thereby mimicking the rotational motion of the first gear 115. The driving gear 117b is configured to mate with the plurality of pinions 119.The hollow shaft 117c transfers the rotational motion of the driven gear 117a to the driving gear 117b.
[0057] In an alternate embodiment, the second gear 117 has two individual gears connected to form a double spur gear. Other functionally and structurally equivalent structures of the second gear 117 are within the scope of the teachings of the present disclosure.
[0058] The pinions 119 are disposed circumferentially around the driving gear 117b within the handle 101, basis the arrangement of the anchoring shafts 110. The driving gear 117b imparts rotational motion to the pinions 119 basis the rotational motion of the anchoring knob 113. A distal end of each of the anchoring shafts is coupled to a respective pinion 119. Thus, the number of the pinions 119 corresponds to the number of the anchoring shafts 110. In an embodiment, there are four pinions 119 and four anchoring shafts 110. The diameter of the pinion 119 ranges from 5 mm to 10 mm. In an exemplary embodiment, the diameter of each pinion 119 is 7 mm. The pinion 119 transfers the rotational motion of the second gear 117 to the anchoring shafts 110.
[0059] A proximal end of the actuating shaft 130 of the device 100 is coupled to the actuating knob 133. The actuating shaft 130 then passes through the lumen of the second gear 117 and the second conduit 103b of the sheath 103. A distal end of the actuating shaft 130 protrudes out of the sheath 103. The rotational motion imparted to the actuating knob 133 by the medical practitioner is transferred to the actuating shaft 130. The actuating shaft 130 may either be flexible or rigid. In an exemplary embodiment, the actuating shaft 130 is flexible. The actuating shaft 130 may be made of one or more materials including, but not limited to, stainless steel, nitinol, titanium, cobalt chromium, and the like. In an embodiment, the actuating shaft 130 is made of stainless steel.
[0060] The distal end of the actuating shaft 130 is provided with an actuating head 131. The actuating head 131 is provided with a second cavity 131a (as shown in Fig. 3c) to removably receive the actuating member 11 of the implant 10. The shape of the second cavity 131a corresponds to the shape of the actuating member 11 of the implant 10. The shape of the second cavity 131a of the actuating head 131 may include, not limited to, pentagon, hexagon, heptagon, triangle, square, and the like. In an exemplary embodiment, as shown in Fig. 3c, the second cavity 131a has a hexagonal shape.
[0061] As shown in Fig. 4a, the device 100 is optionally provided with an introducer 151. The introducer 151 is movably disposed around the at least a portion of the sheath 103 and the implant 10. The introducer 151 is made of one or more materials including, but not limited to, pebax, nylon, polytetrafluoroethylene (PTFE), nylon with PTFE liner, etc. In an exemplary embodiment, the introducer 151 is made of nylon with PTFE liner. In an exemplary embodiment, as shown in Fig. 4a, the introducer 151 has a hollow tubular structure. Other functionally equivalent structure of the introducer is within the scope of the teachings of the present disclosure.
[0062] A proximal end of the introducer 151 is provided with one or more projections 153. The projection 153 may be used to move the introducer 151 with respect to the sheath 103 (and the device 100).
[0063] The introducer 151, in a first position, is configured to constrain the implant 10 in its radially collapsed state (as shown in Fig. 4) while the device 100 is used to position the implant 10 at the valve annulus.
[0064] Before deploying the implant 10 at the valve annulus, the introducer 151 is retracted over the sheath from its first position to a second position as shown in Fig. 4b. In the second position of the introducer 151, the introducer 151 is disposed only around the sheath 103 allowing the implant 10 to self-expand. After the introducer 151 is moved to its second position, the implant 10 is coupled at the valve annulus via the anchoring knob 113 of the device 100 and the valve annulus is constrained using the actuating knob 133 of the device 100.
[0065] The introducer 151 is toggled between its first position and the second position by pushing or pulling the introducer 151 relative to the device 100. The introducer 151, if required by the medical practitioner, may be used to re-constrain the implant 10 by toggling the introducer from its second position to its first position. Re-constraining the implant 10 helps the medical practitioner to reposition the implant 10, if required.
[0066] Fig. 5 depicts an exemplary method 500 of deploying the implant 10 using the device 100.
[0067] The method 500 commences at step 501 by removably coupling the implant 10 to the device 100. Each of the anchoring head 111 of the anchoring shaft 110 is removably coupled to the respective anchoring member 13a of the implant 10. The actuating head 131 of the actuating shaft 130 is engaged with the actuating member 11 of the implant 10.
[0068] At an optional step 503, the introducer 151 is slidably moved to the first position thereby constraining the implant 10 in its radially collapsed state (as shown in Fig. 4a). The introducer 151 helps to percutaneously advance and position the implant 10 using the device 100 without causing any trauma to the surrounding tissue of the vasculature.
[0069] At step 505, the implant 10 is percutaneously advanced to the valve annulus using the device 100 through the vasculature tissue. Apart from the vasculature, other ways of advancing the implant 10 to the valve annulus, such as via explorative surgeries or the like, are within the scope of the teachings of the present disclosure and is at the discretion of the medical practitioner.
[0070] At an optional step 507, the introducer 151 is toggled to its second position from its first position to reveal the implant 10. Upon removal of the introducer 151 from around the implant 10, the implant 10 self-expands (as shown in Fig. 4b).
[0071] At step 509, the anchoring members 13a of the implant 10 (provided with each of the legs of the implant 10) are anchored at the valve annulus by imparting a rotational motion to the anchoring members 13a via the first triggering mechanism, such as the anchoring knob 113 of the device 100. The anchoring knob 113 triggers the first gear 115 to rotate via the movement of the elongate member 115a. The rotational motion to the first gear 115 causes the driven gear 117a of the second gear 117 to rotate. The driving gear 117b mimics the rotational motion of the driven gear 117a through the hollow shaft 117c. The rotational motion of the driving gear 117b is transferred to the anchoring shafts 110 via the respective pinions 119. The anchoring shafts 110 at least partially rotate the respective anchoring members 13a of the implant 10 thereby enabling the anchoring members 13a to pierce the tissue of the valve annulus. This leads to coupling of the implant 10 at the valve annulus.
[0072] At step 511, the implant 10 (and the legs thereof) is radially collapsed using the device 100 (as shown in Figs. 5a and 5b) to constrict the valve annulus. Since the anchoring members 13a are coupled at the valve annulus, radially collapsing the legs of the implant 10 radially constricts the valve annulus along with the legs of the implant 10. The amount of radial collapse is controlled by imparting a pre-defined amount of rotational motion to the second triggering mechanism, such as the actuating knob 133 of the device 100. The actuating knob 133 triggers the actuating shaft 130 to rotate. The actuating shaft 130 actuates the actuating member 11 of the implant 10, which radially collapses the legs 13 (and the anchoring members 13a along with the valve annulus) of the implant 10 (as shown in Fig. 5b). Constricting the valve annulus by radially collapsing the legs 13 of the implant 10 restores the healthy physiological functioning of the valve and minimizes valve regurgitation.
[0073] At step 513, the device 100 is detached from the implant 10 and withdrawn from the vasculature.
[0074] 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. , C , Claims:WE CLAIM
1. A device (100) for deploying an implant (10), the device (100) comprising:
a. at least two triggering mechanisms including a first triggering mechanism and a second triggering mechanism;
b. an anchoring mechanism including a plurality of anchoring shafts (110) operationally coupled to the first triggering mechanism, each of the anchoring shaft (110) including a proximal end and a distal end, the distal end of the anchoring shaft (110) is removably coupled to an implant (10);
c. an actuating mechanism including at least one actuating shaft (130) operationally coupled to the second triggering mechanism, the actuating shaft (130) including a proximal end and a distal end, the distal end of the actuating shaft (130) is removably coupled to the implant (10);
wherein, the at least two triggering mechanisms are configured to trigger one of the anchoring mechanism and the actuating mechanism at a time to anchor and radially collapse the implant (10), respectively,
wherein, the first triggering mechanism configures all the anchoring shafts (110) simultaneously to anchor the implant (10).
2. The device (100) as claimed in claim 1, wherein the at least one of the anchoring shafts (110) and the actuating shaft (130) is either flexible or rigid.
3. The device (100) as claimed in claim 1, wherein the first triggering mechanism includes an anchoring knob (113) disposed within a handle (101) and at least partially protruding out of an opening (101a) of the handle (101).
4. The device (100) as claimed in claim 1, wherein the second triggering mechanism includes an actuating knob (133) disposed within a handle (101) and at least partially protruding out of an opening (101b) of the handle (101).
5. The device (100) as claimed in claim 1, wherein the proximal end of each of the anchoring shaft (110) is operationally coupled to the first triggering mechanism via a first gear (115), a second gear (117), and a respective pinion (119).
6. The device (100) as claimed in claim 1, wherein the first triggering mechanism is coupled to a first gear (115) via an elongate member (115a).
7. The device (100) as claimed in claim 1, wherein the first triggering mechanism is configured to rotate a plurality of pinions (119) coupled to the respective anchoring shaft (110) via a second gear (117).
8. The device (100) as claimed in claim 7, wherein the second gear (117) defines a lumen configured to at least partially receive the actuating shaft (130).
9. The device (100) as claimed in claim 1, wherein the distal end of each of the anchoring shafts (110) is provided with an anchoring head (111) having a first cavity (111a) to removably receive an anchoring member (13a) of the implant (10).
10. The device (100) as claimed in claim 1, wherein the distal end of the actuating shaft (130) is provided with an actuating head (131) having a second cavity (131a) to removably receive an actuating member (11) of the implant (10).
11. The device (100) as claimed in claim 1, wherein the anchoring shafts (110) and the actuating shaft (130) are at least partially disposed within a sheath (103).
12. The device (100) as claimed in claim 1, wherein the device (100) includes a sheath (103) and the implant (10) which is at least partially disposed within an introducer (151).
13. The device (100) as claimed in claim 1, wherein the anchoring shafts (110) are circumferentially arranged around the actuating shaft (130).
14. The device (100) as claimed in claim 1, wherein the anchoring shafts (110) and the actuating shaft (130) is made with at least one of stainless steel, nickel titanium alloy (nitinol, Ni-Ti), titanium, and cobalt-chromium (Co-Cr).
15. The device (100) as claimed in claim 1, wherein the device (100) includes a sheath (103) at least partially enclosing the anchoring shafts (110) and the actuating shaft (130), and defining a plurality of first conduits (103a) for the respective anchoring shafts (110) and at least one second conduit (103b) for the actuating shaft (130).