# Patent

## Title
Implant delivery system and method

## Abstract

An implant delivery system may comprise a catheter including at least one lumen, a guide wire configured to be received in the lumen, and an implant. The guide wire may comprise a clamping mechanism disposed about a distal end of the guide wire. The clamping mechanism may include a first and at least a second jaw wherein at least one of the jaws is configured to pivot between a closed position wherein the jaws define at least one internal cavity between the jaws configured to receive at least a portion of the implant and an open position configured to release the implant. The implant may be configured to be received in the lumen and may comprise a driver configured to be releasably received in the cavity of the clamping mechanism.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
The present application is a divisional of U.S. patent application Ser. No. 11/940,694, filed on Nov. 15, 2007, which is incorporated by reference herein in its entirety.


FIELD OF THE APPLICATION
The present disclosure relates to the repair and/or correction of dysfunctional heart valves, and more particularly pertains to heart valve implants and systems and methods for delivery and implementation of the same.
BACKGROUND
A human heart has four chambers, the left and right atrium and the left and right ventricles. The chambers of the heart alternately expand and contract to pump blood through the vessels of the body. The cycle of the heart includes the simultaneous contraction of the left and right atria, passing blood from the atria to the left and right ventricles. The left and right ventricles then simultaneously contract forcing blood from the heart and through the vessels of the body. In addition to the four chambers, the heart also includes a check valve at the upstream end of each chamber to ensure that blood flows in the correct direction through the body as the heart chambers expand and contract. These valves may become damaged, or otherwise fail to function properly, resulting in their inability to properly close when the downstream chamber contracts. Failure of the valves to properly close may allow blood to flow backward through the valve resulting in decreased blood flow and lower blood pressure.
Mitral regurgitation is a common variety of heart valve dysfunction or insufficiency. Mitral regurgitation occurs when the mitral valve separating the left coronary atrium and the left ventricle fails to properly close. As a result, upon contraction of the left ventricle blood may leak or flow from the left ventricle back into the left atrium, rather than being forced through the aorta. Any disorder that weakens or damages the mitral valve can prevent it from closing properly, thereby causing leakage or regurgitation. Mitral regurgitation is considered to be chronic when the condition persists rather than occurring for only a short period of time.
Regardless of the cause, mitral regurgitation may result in a decrease in blood flow through the body (cardiac output). Correction of mitral regurgitation typically requires surgical intervention. Surgical valve repair or replacement is carried out as an open heart procedure. The repair or replacement surgery may last in the range of about three to five hours, and is carried out with the patient under general anesthesia. The nature of the surgical procedure requires the patient to be placed on a heart-lung machine. Because of the severity/complexity/danger associated with open heart surgical procedures, corrective surgery for mitral regurgitation is typically not recommended until the patient's ejection fraction drops below 60% and/or the left ventricle is larger than 45 mm at rest.



BRIEF DESCRIPTION OF DRAWINGS
Features and advantage of the claimed subject matter will be apparent from the following description of embodiments consistent therewith, which description should be considered in conjunction with the accompanying drawings, wherein:
FIG. 1 is a perspective view of one embodiment of a mitral valve implant delivery system;
FIG. 2 depicts one embodiment of a clamping mechanism and driver in an open position;
FIG. 3 depicts one embodiment of a clamping mechanism and driver in a closed position;
FIG. 4 depicts another embodiment of a clamping mechanism and driver in an open position;
FIG. 5 depicts one embodiment of an implant and a guide wire including a clamping mechanism in the open position prior to loading into a catheter;
FIG. 6 depicts one embodiment of an implant disposed within a clamping mechanism prior to loading into a catheter;
FIG. 7 depicts one embodiment of an implant and guide wire partially disposed within a catheter for securing the implant within the heart; and
FIG. 8 depicts one embodiment of an implant and clamping mechanism disposed outside of the catheter.



DESCRIPTION
Referring to FIG. 1, a perspective view of one embodiment of a percutaneous delivery system 10 for delivering and/or recapturing a mitral valve implant 12 within the heart is shown. The delivery system 10 may include a mitral valve implant 12, a catheter 14 and a guide wire 16 having a clamping mechanism 18 configured to be releasably coupled to the mitral valve implant 12 as will be explained in greater detail hereinbelow.
As shown, the delivery system 10 may include a catheter 14 configured to be percutaneously introduced or inserted into one or more vessels of the body (e.g., one or more veins and/or arteries) and conveyed to the heart for delivery and/or recapture of the mitral valve implant 12. Conveyance of the catheter 14 and/or of the mitral valve implant 12 to the heart may be directed and/or assisted by monitoring the travel of the catheter 14, e.g., via radiographic and/or other imaging techniques and/or by passing the catheter 14 through another, larger catheter already in place (not shown). The catheter 14 may have a length and outer diameter configured to extend from the incision site in the patient's body through one or more veins and/or arteries to the desired location within the heart (e.g., the left ventricle). Additionally, the catheter 14 may define at least one lumen 20 having an internal diameter configured to receive and convey the guide wire 16, the clamping mechanism 18 and the implant 12 from a first end 60 of the catheter 14 to a second end 62 of the catheter 14. The catheter 14 may include a flexible material having sufficient rigidity, strength and inner lubricity to be guided through the blood vessels to the heart and to convey the implant 12. For example, the catheter 14 may include a combination or combinations of polymeric and/or metallic materials having an inner diameter of between 5 French size and 50 French size, an outer diameter of between 0.004 inches 0.250 inches larger than the corresponding inner diameter, and a length of between 10 centimeters and 200 centimeters.
The guide wire 16 may be configured to be disposed within the lumen 20 of the catheter 14 and may have a length greater than the length of the catheter 14. The guide wire 16 may include a flexible wire having sufficient strength and/or rigidity to convey and/or urge the implant 12 through the lumen 20 of the catheter 14. For example, the guide wire 16 may include a combination or combinations of polymeric and/or metallic materials having a diameter of between 0.004 inches and 0.060 inches and a length of between 100 centimeters and 500 centimeters.
A distal end of the guide wire 16 may include a clamping mechanism 18 configured to releasably engage a driver 26 of the mitral valve implant 12. Referring to FIGS. 2 and 3, a close up of the clamping mechanism 18 of FIG. 1 is shown in the open and closed positions, respectively. The clamping mechanism 18 may include a first and at least a second jaw 30, 32 pivotably disposed relative to each other, for example along a pivot point 34. The first and second jaws 30, 32 may form a clam shell arrangement that defines an internal cavity or region 36 between the jaws 30, 32 sized and shaped to receive the driver 26 of the implant 12 when in the closed position as shown in FIG. 3. Additionally, the clamping mechanism 18 may include at least one opening or aperture 37 when in the closed position configured to receive at least a portion of the implant 12, for example, the shaft 52. The opening 37 may be disposed through one or more of the jaws 30, 32.
According to one embodiment, the clamping mechanism 18 may include a lower jaw 32 fixedly coupled to the guide wire 16 and an upper jaw 30 pivotably coupled to the lower jaw 32 about a pivot point 34. The upper jaw 30 may include an opening 40 configured to receive at least a portion of the lower jaw 32 when the upper and lower jaws 30, 32 are in the closed position. While the clamping mechanism 18 is shown having two jaws 30, 32, the clamping mechanism 18 may include three of more jaws. Additionally, while the position of the lower jaw 30 is shown generally fixed relative to the guide wire 16, either or both of the jaws 30, 32 may be pivotably coupled relative to the guide wire 16.
As best seen in FIG. 2, one or more of the interiors of the jaws 30, 32 may include at least one chamfered region 42 which may be configured to engage a portion of the driver 26 to open the clamping mechanism 18 as will be explained further below. For example, the upper and lower jaws 30, 32 may each include one or more of the chamfered regions 42a, 42b disposed proximate a front or distal-most end of the jaws 30, 32. One or more of the chamfered regions 42a, 42b may be configured to cam open the jaws 30, 32.
Turning to FIG. 4, the clamping mechanism 18 may optionally include a biasing device 70 configured to urge the jaws 30, 32 towards the open position. The biasing device 70 may take the place of or be used in conjunction with the one or more of the chamfered regions 42a, 42b. According to one embodiment the biasing device 70 may include a spring or the like configured to urge the upper jaw 30 relative to the lower jaw 32. One or more of the jaws 30, 32 of the clamping mechanism 18 may optionally a shoulder region 72 configured to engage a portion of the driver 26. For example, a generally planar, upright or perpendicular shoulder region 72 may be configured to engage a generally planar, upright or perpendicular shoulder region 74 of the driver 26 when the clamping mechanism 18 is in the closed position preventing the driver 26 from being released from the clamping mechanism 18 as shown in FIG. 4. The shoulder region 72 may also be configured to engage one or more chamfered regions of the driver 26 as discussed below to facilitate opening of the clamping mechanism 18.
Turning now to FIGS. 1 and 5, the implant 12 may include any mitral valve implant such as, but not limited to, a mitral valve implant disclosed in U.S. patent application Ser. No. 11/258,828 filed Oct. 26, 2005 and entitled “Heart Valve Implant”, which is fully incorporated herein by reference. For example, the mitral valve implant 12 may include a spacer or valve body portion 50 (for example, a resiliently deformable spacer configured to be received in the lumen 20 of the catheter 14) which may be coupled to a shaft 52. The shaft 52 may be coupled to at least one anchor portion 54 configured to couple, attach, and/or otherwise secure the mitral valve implant 12 to native coronary tissue. According to one embodiment, at least a portion of the anchor portion 54 may include a generally helical screw or the like configured to be at least partially screwed into the native coronary tissue.
In general, the mitral valve implant 12 may be delivered within the heart and anchored to the native coronary tissue such that at least a portion of the spacer 50 is disposed proximate a mitral valve and the mitral valve implant 12 may interact and/or cooperate with at least a portion of the native mitral valve to reduce and/or eliminate excessive regurgitation. For example, at least a portion of one or more cusps of the heart valve may interact with, engage, and/or seal against at least a portion of the heart valve implant 12 when the heart valve is in a closed condition. The interaction, engagement and/or sealing between at least a portion of at least one cusp and at least a portion of the heart valve implant 12 may reduce and/or eliminate regurgitation in a heart valve, for example, providing insufficient sealing, including only a single cusp, e.g., following removal of a diseased and/or damaged cusp, and/or having a ruptured cordae. A heart valve implant 12 consistent with the present disclosure may be used in connection with various additional and/or alternative defects and/or deficiencies.
The implant 12 may also include at least one driver 26 configured to releasably engage the clamping mechanism 18 of the guide wire 16. The driver 26 may be coupled to at least a portion of the shaft 52. For example, the driver 26 may be rigidly or fixedly coupled about the distal end of the shaft 52 generally opposite the anchoring portion 54. According to one embodiment, the driver 26, FIG. 2, may be fixedly coupled to the distal end of the shaft 52 using at least one set screw 77 or the like extending through an aperture of the driver 26 configured to engage a portion of the shaft 52. According to another embodiment, the driver 26 may be welded or integrally formed with the shaft 52.
The driver 26 may be sized and shaped to be received in the cavity 36 defined by the clamping mechanism 18 such that a portion of the shaft 52 may extend out from the cavity 36 through the opening 37 of the clamping mechanism 18 when in the closed position. According to one embodiment, the driver 26 may include a non-circular shape configured to engage the cavity 36 of the clamping mechanism 18 to substantially prevent rotation of the driver 26 (and therefore the mitral valve implant 12) relative to the guide wire 16 when in the closed position. As shown, the driver 26 may have a generally rectangular shape.
The driver 26 may also include one or more chamfered regions 44 configured to engage one or more of the jaws 30, 32 to cam open the clamping mechanism 18. According to one embodiment, the driver 26 may include a first a second chamfered region 44a, 44b disposed about the upper and lower end regions of the driver 26 proximate the attachment point and/or interface between the driver 26 and the shaft 52. The chambered regions 44 may generally match or correspond to one or more chamfered regions 42 of the jaws 30, 32 and may facilitate opening of the clamping mechanism 18.
In use, the jaws 30, 32 of the clamping mechanism 18 may be placed in the open position as generally shown in FIG. 5 and the driver 26 of the implant 12 may be loaded into the cavity 36 defined by the clamping mechanism 18. The jaws 30, 32 may then be closed around the driver 26 as generally shown in FIG. 6 such that the driver 26 is received within the cavity 36 of the clamping mechanism 18 and at least a portion of the shaft 52 of the implant 12 extends through the opening 37 of the clamping mechanism 18. The guide wire 16 and the implant 12 may then be loaded into a first end 60 of the lumen 20 of catheter 14, with the anchor portion 54 of the implant 12 being loaded first. Once the guide wire 16 and the implant 12 are loaded into the lumen 20, the internal diameter of the lumen 20 may be small enough such that the internal surface of the lumen 20 prevents the jaws 30, 32 of the clamping mechanism 18 from opening and releasing the driver 26, for example, between 5 French size and 50 French size. As a result, the clamping mechanism 18 may engage the driver 26 such that the driver 26 may be substantially coupled to the guide wire 16 while in the lumen 20. At least a portion of the implant 12 (for example, the spacer 50) may be deformable to facilitate loading of the implant 12 within the lumen 20.
The guide wire 16 and implant 12 may then be conveyed through the lumen 20 of the catheter 14 (for example, by applying a force against the guide wire 16 to urge the guide wire 16 through the lumen 20) until at least a portion of the anchor portion 54 of the implant 12 extends outwardly beyond the second end 62 of the catheter 14 and the clamping mechanism 18 is at least partially received within the lumen 20 of the catheter 14 as generally shown in FIG. 7. Once the anchor portion 54 of the implant 12 is beyond the second end 62 of the catheter 14, the anchoring portion 54 of the implant 12 may be placed proximate the native coronary tissue and the guide wire 16 (and therefore the clamping mechanism 18) may be rotated within the catheter 14. According to one embodiment, the cavity 36 and the driver 26 may be configured such that the position of the driver 26 may be generally fixed within the cavity 36 of the clamping mechanism 18 as discussed above. As a result, rotation of the guide wire 14 may cause the implant 12 to rotate thereby causing the anchoring portion 54 to rotate and engage the native coronary tissue in the heart thus securing the implant 12 to the native coronary tissue in the heart.
Once the implant 12 is secured to the native coronary tissue in the heart, the catheter 14 may be pulled back generally away from the implant 12 in the direction of arrow A in FIG. 8 until the clamping mechanism 18 extends beyond the second end 62 of the catheter 14. Once the clamping mechanism 18 is exposed, the implant 12 may be released from the clamping mechanism 18. According to one embodiment, the implant 12 may be released from the clamping mechanism 18 by pulling the guide wire 16 generally away from the implant in the direction of arrow A. The chamfered regions 42 of the jaws 30, 32 may be configured to slide along the chamfered regions 44 of the driver 26 to cam open the jaws 30, 32 and release the driver 26 from the guide wire 16 as generally shown in FIG. 1. Alternatively (or in addition), the biasing device 70 of FIG. 4 may urge jaws 30, 32 open thereby releasing the implant 12 from the clamping mechanism 18 once the clamping mechanism 18 is outside of the catheter 14. In any event, once the implant 12 is released from the clamping mechanism 18, the guide wire 16 and clamping mechanism 18 may then be retracted back into the lumen 20 of the catheter 14 and the catheter 14 may be removed from the patient.
To recapture the implant 12, the catheter 14 may be placed proximate the implant 12. The guide wire 16 may be loaded into the catheter 13 and urged through the lumen 20 until the clamping mechanism 18 extends outwardly from the second end 62 of the catheter 14. With the clamping mechanism 18 in the open position as generally shown in FIG. 1, the jaws 30, 32 may be placed over the driver 26 and the catheter 14 may be slide over the clamping mechanism 18 causing the jaws 30, 32 to engage the driver 26 as generally shown in FIG. 7. The anchor portion 54 of the implant 12 may then be unscrewed by rotating the guide wire 14 and clamping mechanism 18. The implant 12 may then be repositioned within the heart or retracted into the catheter 14 by pulling the guide wire 16 in the direction of arrow A.
The implant 12 herein has been disclosed above in the context of a mitral valve implant. An implant 12 consistent with the present disclosure may also suitably be employed in other applications, e.g., as an implant associated with one of the other valves of the heart, etc. The present disclosure should not, therefore, be construed as being limited to use for reducing and/or preventing regurgitation of the mitral valve.
According to one aspect, the present disclosure features an implant delivery system comprising a catheter including at least one lumen, a guide wire configured to be received in the lumen, and an implant. The guide wire may comprise a clamping mechanism disposed about a distal end of the guide wire. The implant may be configured to be received in the lumen and may comprise a driver configured to be releasably received in the clamping mechanism of the guide wire.
According to another aspect, the present disclosure features a heart valve implant comprising a shaft, a spacer, at least one anchor coupled to a first end region of the shaft, and a driver. The spacer may be coupled to the shaft and may be configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through the heart valve in a closed position. The driver may be coupled to a second end region of the shaft generally opposite the first end region.
According to yet another aspect, the present disclosure features an implant delivery system for delivering an implant. The implant delivery system may comprise a catheter including at least one lumen and a guide wire configured to be received in the lumen. The guide wire may comprise a clamping mechanism disposed about a distal end of the guide wire. The clamping mechanism may also include a first and at least a second jaw wherein at least one of the jaws is configured to pivot between a closed position wherein the jaws define at least one internal cavity between the jaws configured to receive at least a portion of the implant and an open position configured to release the implant.
According to yet a further embodiment, the present disclosure features a method of delivering an implant within a heart using a guide wire. The implant may comprise a driver and the guide wire may comprise a clamping mechanism including a first and at least a second jaw. The method may comprise percutaneously delivering a catheter proximate the heart. The driver of the implant may be received within a cavity defined by the jaws of the clamping mechanism. The guide wire with the implant disposed within the cavity may be loaded into the catheter and conveyed through the catheter until an anchor portion of the implant extends outwardly beyond a distal end of the catheter and the clamping mechanism is still received within the catheter. The anchor portion of said implant may be secured within said heart. The guide wire may be conveyed through the catheter until the clamping mechanism and the implant are disposed outside of the catheter and the driver may be released from the clamping mechanism.
As mentioned above, the present disclosure is not intended to be limited to a system or method which must satisfy one or more of any stated or implied object or feature of the present disclosure and should not be limited to the preferred, exemplary, or primary embodiment(s) described herein. The foregoing description of a preferred embodiment of the present disclosure has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the present disclosure to the precise form disclosed. Obvious modifications or variations are possible in light of the above teachings. The embodiment was chosen and described to provide the best illustration of the principles of the present disclosure and its practical application to thereby enable one of ordinary skill in the art to utilize the present disclosure in various embodiments and with various modifications as is suited to the particular use contemplated. All such modifications and variations are within the scope of the present disclosure as determined by the claims when interpreted in accordance with breadth to which they are fairly, legally and equitably entitled.

## Claims

1. A heart valve implant comprising:
a shaft;
a spacer coupled to said shaft and configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through said heart valve in a closed position; and
a driver coupled to said shaft;
wherein said spacer is deformable between an extended position in which said spacer is configured to interact with at least said portion of said at least one cusp of said heart valve to at least partially restrict said flow of blood through said heart valve in said closed position and a deformed position in which said spacer is configured to be received in a lumen of a delivery catheter.

2. The heart valve implant of claim 1, wherein said shaft extends from a first end region to a second end region.

3. The heart valve implant of claim 2, wherein said driver is coupled to the second end region of said shaft.

4. The heart valve implant of claim 2, further comprising at least one anchor coupled to the first end region of said shaft.

5. The heart valve implant of claim 4, wherein at least a portion of said at least one anchor is configured to at least partially engage with native coronary tissue of said heart.

6. The heart valve implant of claim 5, wherein said at least one anchor comprises a generally helical screw.

7. The heart valve implant of claim 1, wherein said driver comprises a generally perpendicular shoulder region.

8. The heart valve implant of claim 1, wherein said driver comprises an upper end region and a lower end region.

9. The heart valve implant of claim 8, wherein the upper end region and the lower end region comprise at least one chamfered region.

10. The heart valve implant of claim 9, wherein said driver is configured to be received in a cavity defined by a clamping mechanism and wherein said at least one chamfered region is configured to cam open said clamping mechanism.

11. The heart valve implant of claim 1, wherein said driver comprises at least one set screw extending through an aperture of said driver configured to fixedly couple said driver to said second end region of said shaft.

12. The heart valve implant of claim 1, wherein said driver is welded with the second end region of said shaft.

13. A heart valve implant comprising:
a shaft having a first end region and a second end region;
a spacer coupled to said shaft and configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through said heart valve in a closed position;
an anchor coupled to a first end region of said shaft; and
a driver coupled to a second end region of said shaft generally opposite said first end region; wherein said driver comprises an upper end region and a lower end region configured to be received in a cavity defined by a clamping mechanism;
wherein said spacer is deformable between an extended position in which said spacer is configured to interact with at least said portion of said at least one cusp of said heart valve to at least partially restrict said flow of blood through said heart valve in said closed position and a deformed position in which said spacer is configured to be received in a lumen of a delivery catheter.

14. The heart valve implant of claim 13, wherein each of the upper end region and the lower end region comprises at least one chamfered region.

15. The heart valve implant of claim 14, wherein said driver is configured to be received in a cavity defined by a clamping mechanism and wherein said at least one chamfered region is configured to cam open said clamping mechanism.

16. The heart valve implant of claim 13, wherein said driver comprises at least one set screw extending through an aperture of said driver configured to fixedly couple said driver to said second end region of said shaft.

17. The heart valve implant of claim 13, wherein at least a portion of said at least one anchor is configured to at least partially engage with native coronary tissue of said heart.

18. The heart valve implant of claim 17, wherein said at least one anchor comprises a generally helical screw.