Adjustment assembly for an adjustable prosthetic valve device

An adjustment assembly for an adjustable prosthetic valve device includes a gearbox housing formed from two gearbox shells coupled to one another and held together by two gearbox sleeves each having an internal cavity adapted to accommodate respective lateral portions of the gearbox shells when the gearbox shells are coupled to one another. A gear assembly, including a center gear and two driven gears, is supported within the gearbox housing. Gear teeth of each of the driven gears engage gear teeth of the center gear such that rotation of the center gear causes rotation of the driven gears. At least one of the driven gears is adapted to engage a transmission mechanism that transmits the rotation thereof to another part of the adjustable prosthetic valve device to accomplish an adjustment to the size and/or shape of the adjustable prosthetic valve device.

BACKGROUND OF THE INVENTION

The present invention broadly relates generally to an adjustable prosthetic anatomical device for adjusting the size and/or shape of an anatomic orifice or lumen. More particularly, the present invention relates to an adjustment assembly for an adjustable annuloplasty ring for repairing a valve such as a mitral valve in a human patient.

Heart valve disease is a condition in which one or more valves of the heart fail to function properly. Diseased heart valves may be categorized as either stenotic, wherein the valve does not open sufficiently to allow adequate forward flow of blood through the valve, or incompetent, wherein the valve does not close completely causing excessive backward flow of blood through the valve when the valve is closed.

By way of one specific example, the mitral valve is the inflow valve for the left side of the heart. Blood flows from the lungs, where it picks up oxygen, through the pulmonary veins, to the left atrium of the heart. After the left atrium fills with blood, the mitral valve allows blood to flow from the left atrium into the heart's main pumping chamber called the left ventricle. It then closes to keep blood from leaking back into the left atrium or lungs when the left ventricle contracts to push blood out to the body.

Valve disease relating to the mitral valve often involves secondary mitral regurgitation which is the backward flow of blood from the left ventricle to the left atrium resulting from imperfections in the mitral valve. One repair technique for treating regurgitation is called annuloplasty, in which the size and/or shape of the valve annulus is modified by securing a prosthetic adjustable annuloplasty ring to an interior wall of the heart around the valve annulus. The size and/or shape of the annuloplasty ring is adjusted in situ for maintaining coaptation to prevent reversed blood flow.

Examples of an adjustable annuloplasty ring are disclosed in United States Patent Application Publication No. 2011/0066231, the entire disclosure of which is incorporated herein by reference. The disclosed annuloplasty ring includes an adjustment assembly for expanding or contracting the size and/or shape of the ring and of the opening formed by the ring.

BRIEF SUMMARY OF THE INVENTION

The present invention broadly relates generally to an adjustable prosthetic valve device for adjusting the size and/or shape of an anatomic orifice or lumen, and more particularly to an adjustment assembly for use in an adjustable prosthetic valve device.

According to one embodiment, an adjustment assembly for an adjustable prosthetic valve device includes a first gearbox sleeve and a second gearbox sleeve, each gearbox sleeve forming an internal cavity therein, the first and second gearbox sleeves each having at least one opening adjacent a first end thereof. The adjustment assembly also includes a gearbox housing comprising a first gearbox shell and a second gearbox shell adapted to at least partially interlock with one another. The first and second gearbox shells each comprise a center portion having an opening therein, each gearbox shell having a first lateral portion and a second lateral portion. At least one of the first and second lateral portions of each gearbox shell has a projection on an exterior surface thereof, each projection adapted to engage a respective opening formed adjacent the first end of one of the gearbox sleeves when the first and second lateral portions are at least partially inserted within the internal cavities of the first and second gearbox sleeves, whereby the first and second gearbox shells are prevented from separating from one another. The adjustment assembly includes a center gear arranged at least partially within the gearbox housing. The center gear comprises a gear portion and a shaft portion, the shaft portion being adapted to engage an adjustment tool inserted through one of the openings in the gearbox housing. The adjustment assembly further includes a first driven gear and a second driven gear each arranged at least partially within the gearbox housing. The first and second driven gears each comprise a gear portion that engages the gear portion of the center gear, and a shaft portion. The shaft portion of the first driven gear extends at least partially within an opening formed by the first lateral portions of the gearbox shells and the shaft portion of the second driven gear extends at least partially within an opening formed by the second lateral portions of the gearbox shells.

In accordance with the above embodiment, at least one of the first gearbox sleeve and the second gearbox sleeve is integrally molded. The gear portion of the center gear and the shaft portion of the center gear are integrally molded with one another. The gear portion and the shaft portion of at least one of the driven gears are integrally molded with one another. The center gear includes a set of internal threads along at least part of a length of a bore formed therein. The center gear includes a hole having a shape adapted to engage an adjustment mechanism of an adjustment tool.

According to another embodiment, an adjustment assembly for an adjustable prosthetic valve device comprises a first gearbox sleeve having a first end and a second end, and forming a cavity therein, a second gearbox sleeve having a first end and a second end, and forming a cavity therein, and a gearbox housing comprising a first gearbox shell and a second gearbox shell. The first and second gearbox shells each comprise a center portion and two lateral portions extending from opposite sides of the center portion. At least one of the lateral portions of each gearbox shell has a projection on an exterior surface thereof. A first end of each gearbox sleeve includes at least one opening adapted to engage a corresponding projection formed on one of the gearbox shells, whereby the gearbox shells are held together to form a gearbox housing. The gearbox housing is adapted to support a gear assembly therein. The gear assembly comprises a center gear and two driven gears, each of the gears comprising a shaft portion and a gear portion. The gear portion of the center gear engages the gear portions of each of the driven gears. An interior surface of each lateral portion of the gearbox shells provides a bearing surface for the shaft portion of a corresponding one of the driven gears. The center portion of each gearbox shell includes an opening adapted to accommodate an end of the shaft portion of the center gear.

In accordance with this embodiment, at least one of the first gearbox sleeve and the second gearbox sleeve is integrally molded. The shaft portion of the center gear and the gear portion of the center gear are integrally molded with one another. The shaft portion and the gear portion of at least one of the driven gears are integrally molded with one another. The center gear includes a set of internal threads along at least part of a length of a bore formed therein. The center gear includes a hole having a shape adapted to engage an adjustment mechanism of an adjustment tool.

According to a further embodiment, a gearbox sleeve for an adjustable prosthetic valve device comprises a first end forming an internal cavity therein, a second end adapted to engage a spar of the adjustable prosthetic valve device, and at least one opening formed adjacent the first end. The internal cavity is adapted for accommodating portions of at least two gearbox shells therein to hold the at least two gearbox shells together. The at least one opening is adapted to engage a projection formed on an exterior surface of at least one gearbox shell.

In accordance with this embodiment, the gearbox sleeve is integrally molded from a single piece of material.

In a still further embodiment, a gearbox for an adjustable prosthetic valve device comprises a gearbox housing comprising a first gearbox shell and a second gearbox shell adapted to at least partially interlock with one another. The first and second gearbox shells each comprise a center portion having an opening therein. Each gearbox shell has a first lateral portion and a second lateral portion. At least one of the first lateral portion and the second lateral portion of each gearbox shell have a projection on an exterior surface thereof. A center gear is arranged at least partially within the gearbox housing. The center gear comprises a gear portion and a shaft portion, the shaft portion adapted to engage an adjustment tool inserted through one of the openings in the gearbox housing. A first driven gear and a second driven gear are each arranged at least partially within the gearbox housing, the first and second driven gears each comprising a gear portion that engages the gear portion of the center gear and a shaft portion. The shaft portion of the first driven gear extends at least partially within an opening formed by the first lateral portions of the gearbox shells. The shaft portion of the second driven gear extends at least partially within an opening formed by the second lateral portions of the gearbox shells.

In accordance with the above embodiment, the gear portion of the center gear and the shaft portion of the center gear are integrally molded with one another. The gear portion and the shaft portion of at least one of the driven gears are integrally molded with one another. The center gear includes a set of internal threads along at least part of a length of a bore formed therein. The center gear includes a hole having a shape adapted to engage an adjustment mechanism of an adjustment tool.

According to a still further embodiment, a housing for an adjustment assembly for an adjustable prosthetic valve device comprises a first gearbox sleeve and a second gearbox sleeve, each gearbox sleeve forming an internal cavity therein. The first and second gearbox sleeves each have at least one opening adjacent a first end thereof. The housing also includes a gearbox housing comprising a first gearbox shell and a second gearbox shell adapted to at least partially interlock with one another. The first and second gearbox shells each comprise a center portion having an opening therein, each gearbox shell having a first lateral portion and a second lateral portion, wherein at least one of the first and second lateral portions of each gearbox shell has a projection on an exterior surface thereof, each projection adapted to engage a respective opening formed adjacent the first end of one of the gearbox sleeves when the first and second lateral portions are at least partially inserted within the internal cavities of the first and second gearbox sleeves, whereby the first and second gearbox shells are prevented from separating from one another.

In accordance with the above embodiment, at least one of the first gearbox sleeve and the second gearbox sleeve is integrally molded. The gear portion of the center gear and the shaft portion of the center gear are integrally molded with one another.

According to a further embodiment, an adjustment assembly for an adjustable prosthetic valve device is provided as shown and described herein.

DETAILED DESCRIPTION

In describing the preferred embodiments of the subject illustrated and to be described with respect to the drawings, specific terminology will be used for the sake of clarity. However, the invention is not intended to be limited to any specific terms used herein, and it is to be understood that each specific term includes all technical equivalents that operate in a similar manner to accomplish a similar purpose.

FIG. 1shows a perspective view of an adjustable prosthetic anatomical device10, for example, an adjustable annuloplasty ring, which includes an adjustment assembly20according to an exemplary embodiment of the present invention.

InFIG. 2A, a close-up view of adjustment assembly20according to one embodiment is shown, including a gearbox housing100comprised of a first gearbox shell102A and a second gearbox shell102B. As discussed in further detail below, first gearbox shell102A and second gearbox shell102B are held together by a first gearbox sleeve200A and a second gearbox sleeve200B. First gearbox sleeve200A includes a first end204A and a second end208A. Second gearbox sleeve200B includes a first end204B and a second end208B. In this embodiment, first and second gearbox shells102A,102B are generally similar in construction to one another. Accordingly, like reference numerals, appended by ‘A’ or ‘B,’ are used herein to designate similar features of first and second gearbox shells102A,102B, respectively. For example, reference numeral104A designates a center portion of first gearbox shell102A, while reference numeral104B designates a center portion of second gearbox shell102B.

Referring toFIG. 2B, an exploded view of gearbox housing100according to one illustrative embodiment of the present adjustment assembly is shown. First gearbox shell102A includes a center portion104A with a first lateral portion106A and a second lateral portion108A respectively extending from opposite sides thereof. A substantially hollow cavity110A is formed within center portion104A. Second gearbox shell102B includes a center portion104B with a first lateral portion106B and a second lateral portion108B respectively extending from opposite sides thereof. Center portion104B includes an opening116B having an inner surface118B formed therein. A first projection107B is included on an exterior surface of first lateral portion106B and a second projection109B is included on an exterior surface of second lateral portion108B.

In the embodiment shown, first gearbox shell102A and second gearbox shell102B are generally similar in construction to one another and are made from the same material. For example, first gearbox shell102A also includes an opening116A (seeFIG. 5A) in center portion104A that is generally similar to opening116B in center portion104B of second gearbox shell102B. Opening116A in center portion104A includes an inner surface118A similar to inner surface118B of opening116B. Similarly, first gearbox shell102A includes first and second projections107A,109A on first and second lateral portions106A,108A, respectively, which projections107A,109A are generally similar to projections107B,109B, respectively. Center portion104B of second gearbox shell102B also forms a substantially hollow cavity110B therein, which cavity110B is generally similar to cavity110A formed by center portion104A of first gearbox shell102A.

Still with reference toFIG. 2B, first gearbox shell102A includes a set of tabs120A,121A,122A and a set of recesses123A,124A,125A. In this embodiment, second gearbox shell102B includes a corresponding set of tabs120B,121B,122B, which is generally similar to the set of tabs120A,121A,122A of first gearbox shell102A, and a set of recesses123B,124B,125B, which is generally similar to the set of recesses123A,124A,125A of first gearbox shell102A. Tabs120B,121B, and122B are adapted to respectively interlock with recesses123A,124A, and125A, and tabs120A,121A,122A are adapted to respectively interlock with recesses123B,124B, and125B to couple first gearbox shell102A to second gearbox shell102B, forming gearbox housing100. In this embodiment, tab120A is adapted to interlock with recess123B, tab121A is adapted to interlock with recess124B, and tab122A is adapted to interlock with recess125B. Likewise, tab120B is adapted to interlock with recess123A, tab121B is adapted to interlock with recess124A, and tab122B is adapted to interlock with recess125A. This interlocking of tabs120A-122A with recesses123B-125B and tabs120B-122B with recesses123A-125A can enhance the reliability of the engagement between first and second gearbox shells102A,102B when first and second gearbox shells102A,102B are coupled to one another to form gearbox housing100. As discussed in further detail below, a set of gears, or gear assembly, is provided within gearbox housing100, including a center gear150, a first driven gear180A, and a second driven gear180B. By making the gearbox shells102A,102B generally similar to one another in construction, increased efficiency in manufacturing gearbox shells102A,102B can be achieved, for example, with regard to the time and/or cost required to manufacture or mass-produce the gearbox shells. This construction can also facilitate a more reliable engagement between the gearbox shells102A,102B when coupled to one another to form gearbox housing100. However, the gearbox shells102A,102B may be of different constructions and/or made of different materials from one another as desired.

FIG. 2Cprovides a close-up view of an exemplary embodiment of adjustment assembly20with one gearbox shell removed for clarity of illustration. In this embodiment, the gear assembly includes center gear150, first driven gear180A, and second driven gear180B, each disposed at least partially within gearbox housing100. As discussed in further detail below, center gear150engages each of first driven gear180A and second driven gear180B, such that when center gear150is rotated, for example by an external adjustment tool300(seeFIG. 3E), first and second driven gears180A,180B are rotated by center gear150.

Referring toFIGS. 3A-3E, center gear150includes a shaft portion152and a gear portion154. Gear portion154includes gear teeth156surrounding the shaft portion152. Shaft portion152includes a top portion158and a bottom portion160. A shaped hole165is formed in top portion158. As discussed in further detail below, the hole165may include a hexagonal shape as shown, or any other shape suitable for engaging an adjustment mechanism302having a corresponding shape, such that the adjustment mechanism302is substantially incapable of rotating with respect to center gear150while engaging hole165. In one embodiment, a hollow internal cavity162is formed within center gear150in communication with hole165.

Center gear150also includes a threaded insert166including a threaded bore170formed therein. A set of internal threads168is formed along at least a portion of the length of threaded bore170. In the embodiment shown, threaded insert166and bottom portion160are welded to one another by one or more weld joints172therebetween. In some embodiments, one or more weld joints172may be provided, and/or may extend along all or a part of the area of engagement between bottom portion160and threaded insert166.

Threads168of insert166are adapted to engage an engagement element304of adjustment tool300(seeFIG. 3E) used to rotate center gear150to adjust the size and/or shape of adjustable prosthetic anatomical device10. By engaging the engagement element304of the adjustment tool300, threads168of threaded insert166can provide a more reliable engagement between the adjustment tool300and the adjustable device10during a surgical procedure in which the size and/or shape of an anatomic orifice or lumen is changed using the adjustment tool300. Examples of suitable adjustment tools and engagement elements are provided in U.S. Provisional Patent Application Ser. Nos. 60/878,068 and 61/527,801 and in United States Patent Application Publication No. 2011/0066231, the entire disclosures of which are each incorporated herein by reference.

In the illustrative embodiment shown, threads168are provided in insert166, which is a separate piece welded to shaft portion152at one or more weld joints172. However, in other embodiments, threads168may be incorporated directly into center gear150as an integral one-piece construction, such that there is no need for a separate piece and, therefore, no need for a weld joint. Such an integral one-piece construction can advantageously reduce the time and/or cost of manufacturing or mass-producing center gear150, as well as facilitate a more reliable engagement with the adjustment tool300.

In a preferred embodiment, shaft portion152and gear portion154of center gear150are integrally molded with one another as a single part, such that it is not necessary to include a connection (such as a weld joint) connecting gear portion154to shaft portion152.

As discussed in further detail below, gear teeth156are adapted to engage gear teeth of driven gears180A,180B such that the rotation of center gear150is transmitted via driven gears180A,180B to another part of adjustable prosthetic anatomical device10to adjust the size and/or shape of the device. Accordingly, center gear150is rotated by a user applying a rotational force to the adjustment tool300while an adjustment mechanism302of the adjustment tool300is in engagement with hole165of center gear150. In this regard, hole165of center gear150is shaped to engage adjustment mechanism302such that adjustment mechanism302is substantially incapable of rotating with respect to center gear150when the adjustment mechanism302is in engagement with hole165. (SeeFIG. 3E.) For example, in the embodiment shown, hole165includes a hexagonal shape, which is adapted to engage a similarly hexagonally shaped adjustment mechanism. However, hole165may include another shape, such as a square, rectangle, hexagon, pentagon, other quadrilateral, polygonal, or multilateral shape, one or a plurality of teeth, ridges, or engagement protrusions and/or recesses extending radially outward or inward, common or custom-made screwdriver head shapes, other similar and appropriate shapes, or any combination thereof. Alternatively, hole165may include a different shape adapted to engage one or more different types of adjustment mechanisms.

The rotational force applied to the adjustment tool300while the adjustment tool300is in engagement with center gear150via hole165(seeFIG. 3E) is in turn transmitted from shaft portion152to gear portion154for transmission to driven gears180A,180B by virtue of the engagement between gear portion154and the gear portions of driven gears180A,180B. Therefore, a weld joint between shaft portion152and gear portion154would be directly in the load path of the above-described force transmission, requiring the adjusting force to be applied to the weld joint and making that weld joint vulnerable to breaking during the adjustment procedure. Such vulnerability would create a point of potential failure in adjustment assembly20.

Advantageously, in this embodiment of the present adjustment assembly, shaft portion152and gear portion154of center gear150are integrally molded with one another as a single part, such that it is not necessary to include a weld joint therebetween. This construction can lead to increased efficiency in the production of center gear150. As discussed in further detail below, the same is true of driven gears180A,180B according to an embodiment of the present adjustment assembly. Eliminating the weld joints between the gear portions and the shaft portions of the respective gears also advantageously removes points of potential failure from the adjustment assembly, thus reducing the likelihood of a failure or breakage in the adjustment assembly.

FIG. 3Bshows a cross-sectional view of center gear150according to another embodiment, in which shaft portion152and gear portion154are formed together as a single, integrally molded part with one another. Internal cavity162extends within center gear150over the length of shaft portion152, and is in communication with threaded bore170of insert166. Accordingly, as shown inFIG. 3E, when adjustment mechanism302of adjustment tool300is inserted into cavity162through hole165, engagement element304of the adjustment mechanism302can readily engage threads168of threaded insert166to couple adjustment tool300to adjustment assembly20. In the embodiment shown, engagement element304includes a set of threads306adapted to engage threads of threaded insert166. In other embodiments, another suitable and appropriate engagement element could be used.

InFIG. 3C, a top view of center gear150is shown, with hole165formed in top portion158of shaft portion152. Hole165is in communication with a top end of cavity162, while a bottom end of cavity162communicates with bore170of insert166. Hole165may include any shape that is adapted to engage an adjustment mechanism having a corresponding shape, such as adjustment mechanism302of adjustment tool300. For example, hole165may include any such shape, such as a square, rectangle, other quadrilateral, polygon, pentagon, hexagon, or multilateral shape, one or a plurality of teeth, ridges, or engagement protrusions and/or recesses extending radially outward or inward, common or custom-made screwdriver head shapes, other similar and appropriate shapes, or any combination thereof. In the embodiment shown, hole165is shaped as a hexagon, such that hole165can be engaged by a correspondingly hexagonally shaped adjustment mechanism of an adjustment tool. (See also,FIGS. 2C, 3E.) Alternatively, hole165may include a different shape adapted to engage one or more different types of adjustment mechanisms.

In the illustrative embodiment shown inFIGS. 3A-3E, by virtue of the hexagonal shape of hole165, adjustment mechanism302of adjustment tool300is adapted to engage hole165such that adjustment mechanism302is substantially incapable of rotating relative to center gear150while the adjustment mechanism302is inserted within the hexagonal hole165. Therefore, with reference toFIG. 3E, to rotate center gear150, a user can insert adjustment mechanism302having a shape corresponding to the shape of hole165into hole165and subsequently manipulate the adjustment tool300to rotate the adjustment mechanism302relative to an axis151of center gear150. This rotation of the adjustment mechanism302while in engagement with hole165rotates center gear150relative to axis151, which rotation is in turn transmitted to driven gears180A,180B by virtue of the engagement between gear teeth156of gear portion154and gear teeth186A,186B of the gear portions184A,184B of driven gears180A,180B. The arrangement of center gear150and driven gears180A,180B in gearbox housing100, as well as the engagement of center gear150with each of driven gears180A,180B, during this process is also depicted, for example, inFIG. 2C.

FIG. 3Dprovides a bottom plan view of center gear150, including insert166joined to shaft portion152. Bore170of insert166, including threads168formed therein, is also shown. In the embodiment shown, gear portion154is formed as a bevel gear, with gear teeth156thereof arranged at an angle with respect to axis151and adapted to engage gear teeth arranged at an angle to their own longitudinal axis. However, other embodiments may include other types of gears or gear teeth arrangements, such as a worm and worm gear arrangement and/or one or more spur gears.

In this embodiment, gear portion154is located adjacent top portion158of shaft portion152, such that space is provided below gear portion154for the gear portions of driven gears180A,180B to be arranged. Accordingly, this embodiment includes gear teeth156of gear portion154angled downward, i.e., toward bottom portion160of shaft portion152. However, in other embodiments, gear portion154may be arranged differently. For example, gear portion154could be arranged at or adjacent to lower portion160of shaft152, such that space for the gear portions of driven gears180A,180B to be arranged is provided above gear portion154. In such an embodiment, gear teeth156of gear portion154would angle upward, i.e., toward top portion158of shaft portion152, to engage the gear teeth186A,186B of the gear portions184A,184B of driven gears180A,180B.

InFIGS. 4A-4D, a representative driven gear180is shown, which represents the features of driven gears180A,180B according to one exemplary embodiment in which driven gears180A,180B are generally similar in construction to one another. Accordingly, common reference numerals are used herein to designate the features of first driven gear180A and second driven gear180B, appended by characters ‘A’ and ‘B’, respectively. For example, reference numeral182designates a shaft portion of representative driven gear180, with reference numeral182A designating a shaft portion of first driven gear180A and reference numeral182B designating a shaft portion of second driven gear180B. The present description of representative driven gear180is equally applicable to each of first and second driven gears180A,180B.

Representative driven gear180includes shaft portion182and a gear portion184. Gear portion184includes gear teeth186, which are adapted to engage gear teeth156of center gear150. As best shown in the cross-sectional view of driven gear180depicted inFIG. 4B, driven gear180is preferably, though not necessarily, formed as an integrally molded part, such that shaft portion182and gear portion184are formed from a single, contiguous piece of material with one another. Preferably, center gear150and driven gears180A,180B are each manufactured by a metal injection molding (MIM) process, which can advantageously reduce the time and cost associated with the manufacturing thereof. However, center gear150and/or one or both of driven gears180A,180B may alternatively be made from a different manufacturing process, such as milling, casting, or other suitable manufacturing processes, or a combination thereof. Gear portion184is preferably, but not necessarily, arranged to substantially align with a first end181of shaft portion182, such that a first end185of gear portion184substantially coincides with first end181of shaft portion182. As discussed in detail above with respect to center gear150, forming driven gear180as an integrally molded part removes the need for a weld joint or other type of joint connecting gear portion184to shaft portion182, which joint would otherwise be directly in the load path of the force transmission from center gear150to driven gears180A,180B. Advantageously, removing the need for such a joint removes a point of potential failure in adjustment assembly20, which reduces the likelihood of failure or breakage in adjustment assembly20. This embodiment also includes a substantially hollow cavity188formed within driven gear180.

A gradual transition190is included around a periphery of second end183of driven gear180. For example, gradual transition190is shown as a chamfer cut. However, in other embodiments, gradual transition190may include one or more miter cuts, beveled surfaces, rounded edges, other appropriate transitions, or a combination thereof. In still further embodiments, gradual transition190may be omitted, such that a corner or other substantially abrupt transition (not shown) is formed at second end183. Gradual transition190can provide various advantages, such as avoiding stress concentrations in driven gear180and/or the transmission mechanism. Including gradual transition190can also lead to reductions in the time and/or cost of manufacturing and/or mass-producing driven gear180. Additionally, gradual transition190can facilitate a more reliable engagement between driven gears180A,180B and a transmission mechanism (not shown). For example, gradual transition190can facilitate and enhance the speed and simplicity of an assembly process in which the transmission mechanism is accommodated within the inner diameter of cavity188. In one embodiment, the transmission mechanism can comprise a drive cable. As discussed in further detail below, the transmission mechanism can be provided to transmit the rotation of driven gears180A,180B to another part of adjustable prosthetic anatomical device10.

In the illustrative embodiment shown, cavity188is substantially cylindrical and extends along the entire length of shaft portion182to form a first opening187at first end181and a second opening189at second end183of driven gear180. Cavity188can be designed to interact with a transmission mechanism (not shown), such as a cable, rod, wire, or other similar and appropriate transmission mechanism, such that the transmission mechanism transmits the rotation of driven gear180to another part, device, assembly, or mechanism of adjustable prosthetic anatomical device10to accomplish the adjustment to the size and/or shape of the device. U.S. Provisional Patent Application Ser. No. 60/878,068 and United States Patent Application Publication No. 2011/0066231 each provide illustrative examples of suitable transmission mechanisms.

In other embodiments, one or both of first and second ends181,183may be entirely or partially closed, such as by one or more sheets, plates, or surfaces (not shown) extending over first end181and/or second end183. In addition, cavity188may extend over only one or more portions of the length of shaft portion182, rather than the entire length thereof. In still further embodiments, shaft portion182may be formed as a substantially solid part, such that all or part of cavity188is not formed therein.

FIG. 4Cshows driven gear180as viewed along a longitudinal axis191thereof from first end181, such that gear teeth186of gear portion184are shown. As discussed previously, gear teeth186are adapted to engage gear teeth156of center gear150such that rotation of center gear150causes driven gear180to rotate therewith. In turn, the rotation of driven gear180is transmitted by the transmission mechanism to another part of adjustable prosthetic anatomical device10to adjust the size and/or shape of the adjustable prosthetic anatomical device. Preferably, gear portion184is formed as a bevel gear, such that gear teeth186are formed at an angle with respect to longitudinal axis191and adapted to engage gear teeth formed at an angle to their own longitudinal axis. However, in other embodiments, gear portion184may be formed differently, such as including a worm or worm gear arrangement, spur gear, or other appropriate force transmission arrangement.

Referring toFIG. 4D, driven gear180is shown according to a view along longitudinal axis191thereof from second end183. Gradual transition190is formed at second end183. Second opening189is formed at second end183, with cavity188extending along the entire length of driven gear180.

InFIG. 5A, gearbox housing100is shown, formed by first and second gearbox shells102A,102B coupled to one another and held together by first gearbox sleeve200A and second gearbox sleeve200B. In this illustrative embodiment, first and second gearbox sleeves200A,200B are generally similar in construction to one another. Accordingly, common reference numerals are used herein to designate the features of first gearbox sleeve200A and second gearbox sleeve200B, appended by characters ‘A’ and ‘B’, respectively. For example, reference numeral204A designates a first end of first gearbox sleeve200A, while reference numeral204B designates a first end of second gearbox sleeve200B. Additionally,FIGS. 5B-5Ddepict various views of a representative gearbox sleeve200, the present description of which is equally applicable to each of first and second gearbox sleeves200A,200B. In such figures, like reference numerals are used to designate the features of the representative gearbox sleeve200corresponding to the features of first and second gearbox sleeves200A,200B. For example, inFIGS. 5B-5D, reference numeral204designates a first end of representative gearbox sleeve200, the description of which is equally applicable to first ends204A,204B of first and second gearbox sleeves200A,200B, respectively.

First gearbox sleeve200A includes first end204A and a second end208A. Second gearbox sleeve200B includes a first end204B and a second end208B. Second ends208A,208B are each adapted to act as a rail to accommodate another portion of adjustable prosthetic anatomical device10adapted to slide along second ends208A,208B. For example, in one embodiment, second ends208A,208B are adapted to accommodate a spar of an adjustable prosthetic anatomical device, such as an adjustable annuloplasty ring or other adjustable prosthetic anatomic valve device, such that first and second gearbox sleeves200A,200B join gearbox housing100to the spar of the adjustable prosthetic anatomical device.

FIG. 5Bshows a side elevational view of representative gearbox sleeve200, including a first end204and a second end208. In this view, gearbox sleeve200is shown as being substantially straight. However, when used to assemble adjustable prosthetic device10, gearbox sleeve200may include one or more bends, curves, joints, elbows, vertices, undulations, or other similar arrangements provided along the length thereof as desired. (See, e.g.,FIG. 2A).

InFIG. 5C, a cross-sectional view of gearbox sleeve200is shown, taken along section5C-5C ofFIG. 5B. In the embodiment shown, gearbox sleeve200is an integrally molded part formed by injection molding into a single piece of material. In this regard, gearbox sleeve200may be made from any suitable polymer, plastic, metal, or other similar and appropriate material, or a combination thereof. In other embodiments, gearbox sleeve200may be made from multiple subparts combined to one another, some or all of which may be made by other machining or manufacturing processes, such as casting, milling, drilling, lathing, sanding, any other suitable machining or manufacturing process, or a combination thereof.

Still with reference toFIG. 5C, at first end204, a substantially hollow internal cavity210is formed within first end204of gearbox sleeve200.FIG. 5Dshows an enlarged view of first end204of gearbox sleeve200, including cavity210formed therein and having an inner surface206. First end204also includes an outer surface207. Cavity210is designed to accommodate corresponding lateral portions of first and second gearbox shells102A,102B therein when first and second gearbox shells102A,102B are coupled to one another. For example, and as best shown inFIG. 2A, when first and second gearbox shells102A,102B are coupled together to form gearbox housing100, first lateral portions106A,106B of first and second gearbox shells102A,102B, respectively, are coupled to one another, and can be accommodated together within a cavity210A formed in first end204A of first gearbox sleeve200A to hold gearbox shells102A,102B together. Similarly, second lateral portions108A,108B of first and second gearbox shells102A,102B, respectively, are coupled to one another, and can be accommodated together within a cavity210B formed in first end204B of second gearbox sleeve200B.

Referring again toFIG. 5C, a substantially hollow channel212is included within gearbox sleeve200. In the exemplary embodiment shown, channel212is in communication with cavity210and extends along the entire length of gearbox sleeve200to second end208, such that an opening214is formed at second end208. Channel212is designed to accommodate a transmission mechanism (not shown) that interacts with at least one of driven gears180A,180B to transmit the rotation thereof to another part of adjustable prosthetic anatomical device10to actuate that other part to accomplish the adjustment to the size and/or shape of the adjustable prosthetic anatomical device10.

With reference again toFIG. 5A, first gearbox sleeve200A includes an opening202A adjacent first end204A thereof and second gearbox sleeve200B includes an opening202B adjacent first end204B thereof. As shown inFIGS. 5C-5D, representative gearbox sleeve200also includes a second opening203adjacent first end204thereof, which represents second openings203A,203B formed adjacent first ends204A,204B and opposite first slots202A,202B, respectively. Although openings202A,202B,203A,203B are depicted as slots in the embodiment shown, one or more of such openings may, in other embodiments, include another type of opening, for example, a bore, an orifice, an aperture, a hole, or any other suitable and appropriate type of opening adapted to engage a respective projection of a gearbox shell.

In the embodiment shown, openings202and203are each arranged and designed to accommodate a respective one of the projections of first or second gearbox shells102A,102B (seeFIG. 2A), which can provide increased reliability and security in the engagement between gearbox housing100and first and second gearbox sleeves200A,200B. For example, as best shown inFIG. 5A, first and second projections107A,109A of first gearbox shell102A respectively engage first opening202A of first gearbox sleeve200A and first opening202B of second gearbox sleeve200B. Likewise, although not shown in detail, first and second projections107B,109B of second gearbox shell102B respectively engage second opening203A of first gearbox sleeve200A and second opening203B of second gearbox sleeve200B.

In the embodiment shown, openings202and203each extend through the entire thickness of first end204, from inner surface206of cavity210to outer surface207. However, in other embodiments, one or more of openings202and/or203may only extend from inner surface206partially through the thickness of first end204, to instead form a recess, dimple, depression, impression, indentation, or other similar void adapted to accommodate a corresponding one of projections107A,107B,109A,109B.

In a preferred embodiment, the engagements between gearbox housing100and first and second gearbox sleeves200A,200B are provided by virtue of an interference fit between the respective lateral portions of gearbox housing100and cavities210A,210B of first and second gearbox sleeves200A,200B. Thus, when first lateral portions106A,106B are coupled to one another and inserted into cavity210A, first end204A of first gearbox sleeve200A temporarily stretches to allow first lateral portions106A,106B to be inserted far enough to position and align projections107A,107B to engage openings202A,203A, respectively. When projections107A,107B are positioned and aligned to respectively engage openings202A,203A, first end204A is restored to its undeformed size and shape. In this illustrative embodiment, lateral portions108A,108B are similarly accommodated within cavity210B of second gearbox sleeve200B, such that projections109A,109B respectively engage openings202B,203B of second gearbox sleeve200B.

Gearbox sleeves200A,200B are made of a material having sufficient resilience to allow their first ends204A,204B to deform and restore to their natural shape to accommodate first lateral portions106A,106B in first end204A and to accommodate second lateral portions108A,108B in first end204B. For example, as discussed above, gearbox sleeves200A,200B may be made from any suitable polymer, plastic, metal, or other similar and appropriate material, or a combination thereof. Preferably, gearbox sleeves200A,200B are each made from the same material. Other embodiments may include gearbox sleeves200A,200B being made from different materials. While gearbox sleeves200A,200B are each preferably integrally formed from a single, contiguous piece of material, other embodiments may include either or both of gearbox sleeves200A,200B being made of multiple parts joined to one another, which parts may be made of the same or different materials as one another. Further embodiments may only include first ends204A,204B having sufficient resilience to stretch and restore to their undeformed size and shape.

When the lateral portions of gearbox shells102A,102B of gearbox housing100are accommodated within cavities210A,210B of first and second gearbox sleeves200A,200B, respectively, center gear150and first and second driven gears180A,180B are rotatably supported within gearbox housing100. As best shown inFIG. 2C, center gear150and first and second driven gears180A,180B are each rotatably supported within gearbox housing100and are arranged such that gear portions184A,184B of first and second driven gears180A,180B, respectively, each engage gear portion154of center gear150. For clarity of illustration, one gearbox shell102A is not shown inFIG. 2C. In this embodiment, shaft portion182A of first driven gear180A is rotatably accommodated within first lateral portions106A,106B of first and second gearbox shells102A,102B, respectively. Shaft portion182B of second driven gear180B is similarly rotatably accommodated within second lateral portions108A,108B of first and second gearbox shells102A,102B, respectively. Accordingly, shaft portions182A,182B extend at least partially into cavities210A,210B, respectively. Although first and second driven gears180A,180B are shown in this embodiment as being arranged substantially coaxially with one another with their common longitudinal axis191substantially perpendicular to the rotational axis151of center gear150, one or both of first and second driven gears180A,180B may, in other embodiments, be arranged differently in other embodiments, such as being arranged along different longitudinal axes, which axes may be parallel to one another, angled with respect to one another, intersecting, non-intersecting, and/or may be disposed in the same plane or in different planes.

Referring toFIG. 2B, a first surface112A is formed on an inside surface of first lateral portion106A of first gearbox shell102A. An inside surface of second lateral portion108A of first gearbox shell102A includes a second surface114A. Similarly, first lateral portion106B and second lateral portion108B of second gearbox shell102B respectively include a first surface112B and a second surface114B formed on the insides thereof. During use of adjustment assembly20, first surfaces112A and112B cooperate to provide a bearing surface for rotatably supporting driven gear180A during rotation thereof. Likewise, second surfaces114A and114B cooperate to provide a bearing surface for rotatably supporting driven gear180B during rotation thereof. Accordingly, driven gears180A,180B are each securely and reliably arranged and supported within gearbox housing100while being capable of rotation therein.

As best shown inFIGS. 2A, 2B, and 5A, according to one embodiment, opening116A in first gearbox shell102A includes inner surface118A, while opening116B in second gearbox shell102B includes inner surface118B. When center gear150is accommodated within gearbox housing100, inner surfaces118A and118B provide bearing surfaces to rotatably support center gear150. In the embodiment shown, top portion158of shaft portion152is rotatably accommodated by inner surface118A of first gearbox shell102A, while part or all of insert166of center gear150is accommodated by inner surface118B of second gearbox shell102B. In one embodiment, insert166is joined to shaft portion152by one or more weld joints172for rotation with shaft portion152, such that rotatably accommodating insert166within opening116B also rotatably supports center gear150. In another embodiment in which the threaded portion of center gear150is formed as an integral part of shaft portion152, lower portion160of shaft portion152is rotatably accommodated within opening116B.

Referring toFIG. 3E, during operation of adjustment assembly20according to one embodiment, center gear150is engaged by adjustment tool300including engagement mechanism304adapted to engage threads168of threaded insert166and adjustment mechanism302adapted to engage hole165in top portion158of center gear150. While engagement mechanism304engages threads168and adjustment mechanism302engages hole165of center gear150, adjustment tool300is manipulated by a user (e.g., a surgeon) to rotate center gear150within gearbox housing100. Gear teeth156of center gear150are in meshed engagement with gear teeth186A of first driven gear180A and with gear teeth186B of second driven gear180B. Therefore, when center gear150is rotated by the adjustment tool300, first and second driven gears180A,180B are rotated by center gear150. As discussed above, in one embodiment, at least one of first and second driven gears180A,180B is coupled to a transmission mechanism (not shown) that transmits the rotation of first driven gear180A and/or of second driven gear180B to another part of adjustable prosthetic anatomical device10for rotation therewith, which accomplishes the adjustment to the size and/or shape of the device. In this way, adjustment assembly20can be used to adjust the size and/or shape of an adjustable annuloplasty ring. In a preferred embodiment, this adjustment to the size and/or shape of an adjustable annuloplasty ring is performed in situ, i.e., after the adjustable annuloplasty ring is implanted in a patient (not shown), which can facilitate a more reliable and accurate fit between the particular annuloplasty ring size and/or shape required by the individual patient and the size and/or shape of the adjustable annuloplasty ring. However, in other embodiments, it is also possible to adjust the size and/or shape of an adjustable annuloplasty ring prior to or during the implantation thereof into the patient, in addition to or instead of adjusting the size and/or shape in situ.

In addition to adjustable annuloplasty rings for replacing a mitral valve, the present adjustment assembly is not intended to be so limited, and is also suitable for use in various other prosthetic anatomical devices for use in other types of heart valves, blood vessels, other anatomic orifices, lumens, or openings. For example, an adjustment assembly as described herein could be implemented in gastrointestinal surgery, such as in an adjustable prosthetic device for adjusting the size of a gastroesophageal junction to relieve gastric reflux into a patient's esophagus. Further examples of suitable uses for the present adjustment assembly include, without limitation, implementation in adjustable prosthetic devices for urinary or anal incontinence, anastomotic or ductal strictures, arterial stenosis, cervical incompetence, and/or treatment of morbid obesity. One skilled in the art will also appreciate that other appropriate uses of such an adjustment assembly are also possible.