Implantable devices for controlling the size and shape of an anatomical structure or lumen

An implantable device system for controlling the dimensions of internal anatomic passages corrects physiologic dysfunctions resulting from a structural lumen which is either too large or too small. Implantable devices are disclosed which employ various mechanisms for adjusting and maintaining the size of an orifice to which they are attached. Systems permit the implants to be implanted using minimally invasive procedures and permit final adjustments to the dimensions of the implants after the resumption of normal flow of anatomic fluids in situ.

STATEMENT REGARDING SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable.

REFERENCE TO SEQUENCE LISTING

Not Applicable.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to implantable devices for controlling at least one of shape and size of an anatomic structure or lumen.

2. Description of Related Art

There is often a need to reduce the internal circumference of an orifice or other open anatomic structure to narrow or increase the size of the orifice or opening to achieve a desired physiologic effect. Often, such surgical procedures require interruption in the normal physiologic flow of blood, other physiologic fluids, or other structural contents through the orifice or structure. The exact amount of the narrowing or widening required for the desired effect often cannot be fully appreciated until physiologic flow through the orifice or structure is resumed. It would be advantageous, therefore, to have an adjustable means of achieving the narrowing or widening effect, such that the degree of narrowing or widening could be changed after its implantation, and after the resumption of normal flow in situ.

One example of a dysfunction within an anatomic lumen is in the area of cardiac surgery, and specifically valvular repair. Approximately one million open heart surgical procedures are now performed annually in the United States, and twenty percent of these operations are related to cardiac valves.

The field of cardiac surgery was previously transformed by the introduction of the pump oxygenator, which allowed open heart surgery to be performed. Valvular heart surgery was made possible by the further introduction of the mechanical ball-valve prosthesis, and many modifications and different forms of prosthetic heart valves have since been developed. However, the ideal prosthetic valve has yet to be designed, which attests to the elegant form and function of the native heart valve.

As a result of the difficulties in engineering a perfect prosthetic heart valve, there has been growing interest in repairing a patient's native valve. These efforts have documented equal long-term durability to the use of mechanical prostheses, with added benefits of better ventricular performance due to preservation of the subvalvular mechanisms and obviation of the need for chronic anticoagulation. Mitral valve repair has become one of the most rapidly growing areas in adult cardiac surgery today.

Mitral valve disease can be subdivided into intrinsic valve disturbances and pathology extrinsic to the mitral valve ultimately affecting valvular function. Although these subdivisions exist, many of the repair techniques and overall operative approaches are similar in the various pathologies that exist.

Historically, most valvular pathology was secondary to rheumatic heart disease, a result of a streptococcal infection, most commonly affecting the mitral valve, followed by the aortic valve, and least often the pulmonic valve. The results of the infectious process are mitral stenosis and aortic stenosis, followed by mitral insufficiency and aortic insufficiency. With the advent of better antibiotic therapies, the incidence of rheumatic heart disease is on the decline, and accounts for a smaller percentage of valvular heart conditions in the developed world of the present day. Commissurotomy of rheumatic mitral stenosis was an early example of commonly practiced mitral valve repair outside of the realm of congenital heart defects. However, the repairs of rheumatic insufficient valves have not met with good results due to the underlying valve pathology and the progression of disease.

Most mitral valve disease other than rheumatic results in valvular insufficiency that is generally amenable to repair. Chordae rupture is a common cause of mitral insufficiency, resulting in a focal area of regurgitation. Classically, one of the first successful and accepted surgical repairs was for ruptured chordae of the posterior mitral leaflet. The technical feasibility of this repair, its reproducible good results, and its long-term durability led the pioneer surgeons in the field of mitral valve repair to attempt repairs of other valve pathologies.

Mitral valve prolapse is a fairly common condition that leads over time to valvular insufficiency. In this disease, the plane of coaptation of the anterior and posterior leaflets is “atrialized” relative to a normal valve. This problem may readily be repaired by restoring the plane of coaptation into the ventricle.

The papillary muscles within the left ventricle support the mitral valve and aid in its function. Papillary muscle dysfunction, whether due to infarction or ischemia from coronary artery disease, often leads to mitral insufficiency (commonly referred to as ischemic mitral insufficiency). Within the scope of mitral valve disease, this is the most rapidly growing area for valve repair. Historically, only patients with severe mitral insufficiency were repaired or replaced, but there is increasing support in the surgical literature to support valve repair in patients with moderate insufficiency that is attributable to ischemic mitral insufficiency. Early aggressive valve repair in this patient population has been shown to increase survival and improve long-term ventricular function.

In addition, in patients with dilated cardiomyopathy the etiology of mitral insufficiency is the lack of coaptation of the valve leaflets from a dilated ventricle. The resultant regurgitation is due to the lack of coaptation of the leaflets. There is a growing trend to repair these valves, thereby repairing the insufficiency and restoring ventricular geometry, thus improving overall ventricular function.

Two essential features of mitral valve repair are to fix primary valvular pathology (if present) and to support the annulus or reduce the annular dimension using a prosthesis that is commonly in the form of a ring or band. The problem encountered in mitral valve repair is the surgeon's inability to fully assess the effectiveness of the repair until the heart has been fully closed, and the patient is weaned off cardiopulmonary bypass. Once this has been achieved, valvular function can be assessed in the operating room using transesophageal echocardiography (TEE). If significant residual valvular insufficiency is then documented, the surgeon must re-arrest the heart, re-open the heart, and then re-repair or replace the valve. This increases overall operative, anesthesia, and bypass times, and therefore increases the overall operative risks.

If the prosthesis used to reduce the annulus is larger than the ideal size, mitral insufficiency may persist. If the prosthesis is too small, mitral stenosis may result.

The need exists, therefore, for an adjustable prosthesis that would allow a surgeon to adjust the annular dimension in situ in a beating heart under TEE guidance or other diagnostic modalities to achieve optimal valvular sufficiency and function.

Cardiac surgery is but one example of a setting in which adjustment of the annular dimension of an anatomic orifice in situ would be desirable. Another example is in the field of gastrointestinal surgery, where the Nissen fundoplication procedure has long been used to narrow the gastro-esophageal junction for relief of gastric reflux into the esophagus. In this setting, a surgeon is conventionally faced with the tension between creating sufficient narrowing to achieve reflux control, but avoiding excessive narrowing that may interfere with the passage of nutrient contents from the esophagus into the stomach. Again, it would be desirable to have a method and apparatus by which the extent to which the gastro-esophageal junction is narrowed could be adjusted in situ to achieve optimal balance between these two competing interests.

Aside from the problem of adjusting the internal circumference of body passages in situ, there is often a need in medicine and surgery to place a prosthetic implant at a desired recipient anatomic site. For example, existing methods proposed for percutaneous mitral repair include approaches through either the coronary sinus or percutaneous attempts to affix the anterior mitral leaflet to the posterior mitral leaflet. Significant clinical and logistical problems attend both of these existing technologies. In the case of the coronary sinus procedures, percutaneous access to the coronary sinus is technically difficult and time consuming to achieve, with procedures which may require several hours to properly access the coronary sinus. Moreover, these procedures employ incomplete annular rings, which compromise their physiologic effect. Such procedures are typically not effective for improving mitral regurgitation by more than one clinical grade. Finally, coronary sinus procedures carry the potentially disastrous risks of either fatal tears or catastrophic thrombosis of the coronary sinus.

Similarly, percutaneous procedures which employ sutures, clips, or other devices to affix the anterior mitral leaflets to the posterior mitral leaflets also have limited reparative capabilities. Such procedures are also typically ineffective in providing a complete repair of mitral regurgitation. Furthermore, surgical experience indicates that such methods are not durable, with likely separation of the affixed valve leaflets. These procedures also fail to address the pathophysiololgy of the dilated mitral annulus in ischemic heart disease. As a result of the residual anatomic pathology, no ventricular remodeling or improved ventricular function is likely with these procedures.

The need exists, therefore, for a delivery system and methods for its use that would avoid the need for open surgery in such exemplary circumstances, and allow delivery, placement, and adjustment of a prosthetic implant to reduce the diameter of such a mitral annulus in a percutaneous or other minimally invasive procedure, while still achieving clinical and physiologic results that are at least the equivalent of the yields of the best open surgical procedures for these same problems.

The preceding cardiac applications are only examples of some applications according to the present invention. Another exemplary application anticipated by the present invention is in the field of gastrointestinal surgery, where the aforementioned Nissen fundoplication procedure has long been used to narrow the gastro-esophageal junction for relief of gastric reflux into the esophagus. In this setting, a surgeon is conventionally faced with the tension between creating sufficient narrowing to achieve reflux control, but avoiding excessive narrowing that may interfere with the passage of nutrient contents from the esophagus into the stomach. Additionally, “gas bloat” may cause the inability to belch, a common complication of over-narrowing of the GE junction. An adjustable prosthetic implant according to the present invention could allow in situ adjustment in such a setting under physiologic assessment after primary surgical closure.

Such an adjustable prosthetic implant according to the present invention could be placed endoscopically, percutaneously, or with an endoscope placed within a body cavity or organ, or by trans-abdominal or trans-thoracic approaches. In addition, such an adjustable prosthetic implant according to the present invention could be coupled with an adjustment means capable of being placed in the subcutaneous or other anatomic tissues within the body, such that remote adjustments could be made to the implant during physiologic function of the implant. This adjustment means can also be contained within the implant and adjusted remotely, i.e. remote control adjustment. Such an adjustment means might be capable of removal from the body, or might be retained within the body indefinitely for later adjustment.

The present invention and the methods for its use anticipate many alternate embodiments in other potential applications in the broad fields of medicine and surgery. Among the other potential applications anticipated according to the present invention are adjustable implants for use in the treatment of morbid obesity, urinary incontinence, anastomotic strictures, arterial stenosis, urinary incontinence, cervical incompetence, ductal strictures, and anal incontinence. The preceding discussions are intended to be exemplary embodiments according to the present invention and should not be construed to limit the present invention and the methods for its use in any way.

SUMMARY OF THE INVENTION

Implantable devices, methods and systems for controlling at least one of shape and size of an anatomical structure or lumen, including minimally invasive implantable devices and methods are disclosed herein. In embodiments, an implantable device is provided that has a adjustable member configured to adjust the dimensions of the implantable device. A rotatable or torqueable adjustment tool is configured to provide adjustment of the dimensions of the implantable device. Such adjustments may be under the control of an operator, and may be effected my manual force alone or may be effected with the aid of gears, motors, or other mechanical, electrical, hydraulic or other aids. An adjustment tool is configured to engage with an implantable device in a non-planar orientation, so that at least a portion of the adjustment tool is non-planar with respect to the plane defined by the implantable device and/or tissue in contact with or adjacent to, the implantable device. For example, where the implantable device is in contact with, or adjacent to, a valve annulus, at least a portion of the adjustment tool is non-planar with respect to the valve annulus. Embodiments of the devices, systems and methods disclosed herein provide implantable devices and methods for controlling a perimeter of an anatomic orifice or lumen, including minimally invasive implantable devices and methods for controlling a perimeter of an anatomic orifice or lumen.

In embodiments of the present invention, an implantable device is provided for controlling at least one or more of a shape, a size, a configuration, or other attribute of an anatomical structure or lumen. An implantable device has an adjustable member configured to adjust the dimensions of the implantable device. An adjustment tool is configured to provide adjustment of the dimensions of the implantable device, the adjustment tool providing translated motion through rotation.

In embodiments of the present invention, having an implantable device for controlling at least one of shape and size of an anatomical structure or lumen, an adjustable member is provided that is configured to adjust a dimension of the implantable device. In embodiments, an adjustable member having features of the invention may include first and second bands, An adjustable member having features of the invention may be configured to adjust a dimension of an implantable device, the implantable device having an anterior portion, a posterior portion and dual threads that provide preferential adjustment of one side or the other of the implantable device:

Disclosed herein are methods, systems and devices for positioning an adjustable implant adjacent target tissue, and for attaching an adjustable implant device to target tissue. In embodiments of devices having features of the invention, a device for positioning an adjustable implant device adjacent to target tissue, includes an implant tool holding element configured to releasably hold the adjustable implant device; a tool holding element configured to hold an adjustment tool and to allow operation thereof while so held, the adjustment tool being configured to adjust the adjustable implant device; and an implant securing element having a configuration effective to secure the implant to the target tissue.

In embodiments of the devices having features of the invention, an implant securing element may have a first configuration adapted for penetrating tissue and a tip portion adapted for penetrating tissue, and a second configuration adapted for engaging tissue. In embodiments, an implant securing element in the second configuration may be adapted to engage tissue and to engage and adjustable implant device, effective to secure the adjustable implant device to tissue.

Methods, systems and devices having features of the invention may further include an implant positioning element that is configured to guide an adjustable implant device effective to properly orient the adjustable implant device adjacent target tissue for securing the implant device to target tissue. Such positioning may be effective to guide or orient, or both, the implant to a desired position or orientation, or both, within an anatomic orifice or lumen.

In embodiments, an implant securing element is configured to co-operate with an implant positioning element effective to secure the adjustable implant device to target tissue while the adjustable implant device is properly positioned adjacent the anatomic orifice or lumen. An implant positioning element may include an expansible portion adapted to assume a collapsed first configuration and to assume an expanded second configuration. An implant positioning element may be configured to allow fluid to pass therethough. In embodiments, am implant positioning element is configured to allow fluid to pass therethrough when disposed in a second configuration, or when disposed in a first configuration, or both. In embodiments, an implant positioning element may include a fenestrated surface; may include a mesh; and may include a plurality of elongated elements forming a whisk, the elongated elements may include flexible elements, which may include metal wires, an organic polymer material, or other flexible material.

In embodiments of the methods, systems, and devices having features of the invention, an adjustable implant may have an expansible internal perimeter, and an implant positioning element may be configured to expand as the internal perimeter of the adjustable implant is increased. In embodiments of the methods, systems and devices having features of the invention, and adjustable implant may have an expansible internal perimeter, and an implant positioning element may be configured toe expand so as to effect the increase of the internal perimeter of the adjustable implant device. In embodiments, an implant positioning element may be configures to contract, and may be configured toe reduce an internal perimeter of an adjustable implant device.

In embodiments of the methods, systems, and devices having features of the invention, an implant securing element may have a first configuration and a second configuration. A first configuration may be substantially straight configuration, and a second configuration may be a non-linear configuration. In embodiments, a second configuration may have one or more configurations elements, and may include a configuration element that is a curve, a loop, a coil, a spiral coil, a barb, a bifurcation, an anchor shape, or a combination thereof. In embodiments, an implant securing device may include at least two configurations elements selected from a curve, a loop, a coil, a spiral coil, a barb, a bifurcation, an anchor shape. Such configuration elements may be at least two of the same configuration element, or may be at least two different configuration elements.

In embodiments of the methods, systems, and devices having features of the invention, an implant securing element is configured toe engage an implant device and to engage tissue. Such an engagement may be effective to secure an adjustable implant device to tissue, such as tissue adjacent to an anatomical orifice or lumen. In embodiments, an implant securing element may be configured to engage tissue and to coil around at least a portion of an implant device; may be configured to engage tissue and to pass through at least a portion of an implant device; or may be otherwise configured to engage tissue and to engage an adjustable implant device, effective to secure an adjustable implant device to tissue. In embodiments, engagement of tissue may include penetration of tissue, anchoring within tissue, attaching to tissue, or other means of engaging tissue.

In embodiments of the methods, systems, and devices having features of the invention, an implant holding element may include a housing configured to house an implant securing element. A housing may be configured to allow egress of at least a portion of an implant securing element from the housing. An implant securing element may be configured to be housed or substantially contained within a housing in a first configuration. A housing may include a substantially linear portion, and an implant securing element first configuration may be linear, or substantially straight configuration. In embodiments, a housing may include a non-linear portion, and an implant securing element first configuration may include a non-linear configuration.

Embodiments of the methods, systems, and devices having features of the invention may include or be configured to cooperate or work with an adjustment tool that is configured to operably engage with an adjustable implant device having features of the invention, effective to adjust a dimension of the adjustable implant device.

Also discussed herein are methods of securing an adjustable implant device to target tissue. Target tissue may be, for example, tissue adjacent an anatomical orifice or lumen. A method of securing an adjustable implant device to target tissue having an anatomic orifice or lumen may have steps including: providing an adjustable implant having an expansible internal perimeter and configured for controlling the internal perimeter of an anatomic orifice or lumen; providing an adjustable implant holding element that is configured to releasably hold the adjustable implant; providing an implant securing element that is configured to assume at least a first configuration (adapted for penetrating tissue) and a second configuration (adapted for engaging tissue), where the implant securing element has a tip portion that is configured to penetrate tissue; placing the adjustable implant device at a desired location adjacent the target tissue near the adjustable implant device; advancing the implant securing element in a first configuration effective that the implant securing element tip portion penetrates tissue; engaging tissue with the implant securing element in a second configuration; and engaging the adjustable implant device with the implant securing element while the implant securing element secures the adjustable implant device to target tissue. An implant securing element may have a configuration that includes on or more of a curve, a loop, a coil, a spiral coil, a barb, a bifurcation, an anchor shape. An implant securing element may have more than one of the same configuration element.

Devices, systems and methods having features of the invention may include, provide, or use a housing for housing an implant securing element. In embodiments of methods having features of the invention, an advancing step may include a step of advancing at least a portion of an implant securing element outside the housing.

Methods having features of the invention may further include that a placing step includes placing the implant in contact with target tissue; that an advancing step includes moving the implant securing element tip portion, effective that the tip portion enters tissue at a location on a tissue surface; and that an engaging tissue step includes moving the tip portion effective that the tip portion exits tissue from a location on the tissue surface different than the entry location.

Methods of securing an adjustable implant device to target tissue having features of the invention may further include an engaging step where the engaging includes passing at least a portion of an implant securing element around at least a portion of the adjustable implant device, or may further include passing at least a portion of the implant securing element through at least a portion of the adjustable implant device. An adjustable implant device may include a material that is configured to hold the implant securing element and through which the implant securing element tip portion may pass. A material suitable for such methods may include a woven material. An adjustable implant device may have a passage that is configured to accept a portion of an implant securing element. In embodiments, a passage configured to accept a portion of an implant securing element may include a loop, and may include a hole providing a pathway completely through a portion of said adjustable implant device.

Embodiments of methods having features of the invention may further adjusting the internal perimeter of an adjustable implant device. An adjusting step may include adjusting a tool that is releasably coupled to an adjustable implant device; may further include, where an implant device is held by an implant holding element, releasing the adjustable implant device from the implant holding element.

Also provided are systems having features of the inventions. In embodiments, a system for controlling the internal perimeter of an anatomic orifice or lumen disposed adjacent target tissue may include: an adjustable implant device having an adjustable perimeter, a perimeter adjustment mechanism, and a docking element that is configured to operably engage an adjustment tool, where the perimeter adjustment mechanism is operably connected with the docking element; an adjustment tool that is configured to operably engage the docking element; and an implant placement device that includes an implant engagement element and an implant securing element that is configured to secure the implant to target tissue.

A system having features of the invention may also have an implant securing element that has a tip portion configured to penetrate tissue. An implant securing element tip portion configured to penetrate tissue may be configured to assume more than one configuration. Such configurations may include at least a first configuration and a second configuration, the first configuration being adapted for penetrating tissue, and the second configuration being adapted for engaging tissue. A second configuration adapted for engaging tissue may include a configuration element that is selected from a curve, a loop, a coil, a spiral coil, a barb, a bifurcation, and an anchor shape. An implant securing element tip portion configured to penetrate tissue may have at least two configuration elements, which may be at least two of the same configuration element, or may be at least two different configuration elements. In embodiments, an implant securing element tip portion configured to penetrate tissue may be configured to engage tissue and to engage an adjustable implant device, effective to secure an adjustable implant device to tissue.

A system having features of the invention may further include an implant positioning device that is configured to properly orient an adjustable implant device for securing the adjustable implant device to target tissue. An implant positioning device may be configured to guide an adjustable implant device effective to properly orient said adjustable implant device adjacent target tissue for securing to said target tissue. In embodiments, an implant positioning device may include a plurality of flexible elements. In embodiments, an implant positioning device may have a fenestrated surface, or a mesh, configured to allow fluid to pass therethrough.

In embodiments, a system having features of the invention may include an expansible element that is adapted to assume a collapsed first configuration and to assume an expanded second configuration. An expansible element may be configured to allow fluid to pass therethrough when disposed in a second configuration, or a first configuration, or both. In embodiments, the flexible elements may be or include elongated elements, such as metal wires. Flexible elements may be made of, or include, an organic polymer material.

In embodiments of systems having features of the invention, an implant positioning device may have a plurality of elongated elements forming a whisk. An implant positioning device may be configured to expand as the adjustable perimeter of the adjustable implant is increased, and may be configured to expand so as to effect the increase of the adjustable perimeter of the adjustable implant. In embodiments, an implant positioning device may be configured to contract, and may be configured to reduce an internal perimeter of an adjustable implant device.

Devices, systems and methods having features of the invention allow an operator, such as a surgeon, to adjust a dimension of an anatomical orifice or lumen in a patient, thereby providing for better operation and function of that anatomical orifice or lumen and improving the health and quality of life of that patient. The devices, systems and methods disclosed herein provide advantages over the prior art in that such adjustments may be made with less trauma to the patient, and such adjustments may be made, and re-made, to provide adjustments that are adapted to the individual patient and to changes in the physiology or function of the anatomical orifice or lumen over time or as a result of treatment. Where, for example, the anatomical orifice or lumen is a heart valve, the devices, systems and methods disclosed herein provide for repair of a heart valve while the heart remains beating, and for adjustment of the repair to accommodate changes to valve function under different conditions, as may be found following surgery, to provide adjustments tailored to the patient during recovery and to insure that the valvular adjustments are suited to the patients condition not just during surgery, but also after surgery.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings, in which like numerals indicate like elements throughout the several views, an exemplary implant10comprising an implant body15is shown inFIG. 1. The implant body may be provided in a shape and size determined by the anatomic needs of an intended native recipient anatomic site within a mammalian patient. Such a native recipient anatomic site may be, by way of illustration and not by way of limitation, a heart valve, the esophagus near the gastro-esophageal junction, the anus, or other anatomic sites within a mammalian body that are creating dysfunction that might be relieved by an implant capable of changing the size and shape of that site and maintaining a desired size and shape after surgery.

The implant10ofFIG. 1comprises a circular implant body15which is provided with adjustable corrugated sections20alternating with intervening grommet-like attachment means25having narrowed intermediate neck portions. As can be seen inFIGS. 2 and 3, the implant body15may be secured to the annulus of a heart valve30by a fixation means such as a suture35secured over or through the attachment means25. The corrugated sections20fold and unfold as the circumference of the implant body15shortens or lengthens. Adjustment of the implant10in situ may decrease the overall size of the heart valve30, increasing the coaptation of the valve leaflets40, and changing the configuration from that shown inFIG. 2to that shown inFIG. 3.

An additional exemplary embodiment100of the present invention is shown inFIGS. 4 and 5, with an open operative cardiac incision105in a heart110shown inFIG. 4, and closure of the cardiac incision105inFIG. 5. As shown inFIG. 4, the exemplary adjustable implant100according to the present invention comprises an implant body115with attachment means120that allows fixation to the annulus of a mitral valve125. The exemplary adjustable implant100is further provided with an adjustment means130that is controlled by an attached or coupled adjustment tool135. After closure of the myocardial incision105inFIG. 5, the adjustment tool135remains attached or coupled to the adjustment means130, so that the size and shape of the implant100may further be affected after physiologic flow through the heart110is resumed, but with the chest incision still open. Once the desired shape and function are achieved, the adjustment tool135may be disengaged from the adjustment means130and withdrawn from the myocardial incision105. In various embodiments according to the present invention, the adjustment means130may be configured and placed to allow retention by or re-introduction of the adjustment tool135for adjustment following closure of the chest incision.

To use the implant100ofFIGS. 4 and 5, the physician makes the open operative incision105in the heart110, as shown inFIG. 4, in the conventional manner. The implant100, mounted at the forward end of adjustment tool135, is then advanced through the incision105and sutured to the annulus of the mitral valve125. The adjustment tool135is then manipulated, e.g., rotated, depending upon the design of the adjustment means130, to cause the adjustment means to reduce the size of the implant body115, and hence the underlying mitral valve125to which it is sutured, to an approximate size. The myocardial incision105can now be closed, as shown inFIG. 5, leaving the adjustment tool extending through the incision for post-operative adjustment.

Once the patient has been taken “off pump” and normal flow of blood through the heart110has resumed, but before the chest incision has been closed, further adjustments to the size of the mitral valve125can be made by manipulating the adjustment tool135.

FIGS. 6-8show an exemplary adjustment means200for adjusting the circumference of an annular implant such as the implant100previously described. The adjustment means200comprises a rack and pinion system in which a first cam205with geared teeth210and an engagement coupler215turns on a first axel220. In this example, the first cam205engages a geared rack225on one or more surfaces of a first band230. The first band230passes between the first cam205and a second cam235that turns on a second axel240that is joined to a second band245. As shown inFIG. 8, the first and second axels220,240are maintained in suitable spaced-apart relation by means of a bracket250formed at the end of the second band245.

The adjustment means200is preferably set within a hollow annular implant100of the type previously described, though it is possible to use the adjustment means in a stand-alone configuration wherein the first and second bands230,245are opposing ends of the same continuous annular structure. In either event, to adjust the length of an implant comprising the adjustment means200, a tool such as a hex wrench engages the engagement coupler215on the first cam205and rotates the first cam in a counterclockwise direction as shown inFIG. 7, as indicated by the arrow255. Rotation of the first cam205causes the teeth210to drive the rack225to move the first band230toward the right, as indicated by the arrow260inFIG. 7. This movement of the first band tightens the circumference of the annular implant. If the physician inadvertently adjusts the implant too tight, reversing direction of the engagement coupler215will loosen the implant.

In various embodiments according to the present invention, the first and second bands230,245may be separate structures, or they may be opposing ends of the same continuous structure. In such an embodiment, when motion is imparted to the engagement coupler215, the first cam205is rotated, causing the geared teeth210to engage the geared rack225, and causing the first band230to move with respect to the second band245to adjust the circumference of an implant.

FIG. 9shows a somewhat different configuration of an exemplary engagement means300according to the present invention, in which there is no engagement coupler, and a bracket350is provided on both sides of the cams to maintain the first cam315and the second cam320in close approximation. In one proposed embodiment, the bracket is designed with close tolerances so as to press the first band330closely against the second band345, thereby to hold the bands in fixed relative position by friction. In another proposed embodiment, the brackets350are fabricated from an elastic material such that the cams315,320can be spread apart to insert the first band330between the cams, whereupon the cams are pulled back together with sufficient force to hold the bands330,345in fixed relative position by friction. In still another proposed embodiment involving an elastic mounting arrangement between the cams315,320, the lower edge of the first band330and the upper edge of the second band345have mating frictional or mechanical surfaces, whereby the cams315,320can be spread apart to permit relative movement between the bands or released to clamp the bands together in fixed relation.

FIG. 10shows an exemplary attachment means400for an implant according to the present invention. The attachment means400could be used, for example, in place of the attachment means25of the implant10. The attachment means400takes the form of a grommet410comprising a wall415defining a lumen420and an attachment surface425. Such an attachment means would be used with the implant body extending through the lumen420and with fixation devices such as sutures or wires either tied over or affixed through the attachment surface425.

FIG. 11shows another alternate embodiment of an attachment means500for an implant according to the present invention. The attachment means500could also be used, for example, in place of the attachment means25of the implant10.FIG. 11shows an attachment means500in the form of a hollow tube or tube segment510comprising a wall515defining a lumen520, an outer surface525, and an attachment tab530. Such an attachment means would be used with the implant body extending through the lumen520and with fixation devices such as sutures or wires either tied or otherwise affixed over or through the attachment tab530. Such fixation devices might be placed through holes535provided in the attachment tab530. Alternately a solid attachment tab530might be provided, and the fixation devices might be passed through the solid tab. Modifications of these attachment means may be used in conjunction with a sutureless attachment system.

FIGS. 12-18show another embodiment of a percutaneous annuloplasty device according to the present invention, in which an implant/delivery system array600includes a housing sheath605(not seen inFIG. 12), an actuating catheter610coaxially slidably mounted within the housing sheath605, and a core catheter615coaxially slidably mounted within the actuating catheter610. The core catheter has a central lumen616(FIG. 13). The actuating catheter610and core catheter615may be round tubular structures, or as shown inFIG. 13, either or both of the actuating and core catheters may be provided with one or more keyed ridges618,620respectively to be received by one or more reciprocal slots622,624within the inner lumen of either the housing sheath605or the actuating catheter610, respectively. Such keyed ridges618,620would limit internal rotation of an inner element within an outer element, should such restriction be desirable to maintain control of the inner contents from inadvertent displacement due to undersired rotational motion during use.

The implant/delivery system array600includes a distal tip625at the forward end of the core catheter615. One or more radial implant support arms630have their distal ends632pivotably or bendably mounted to the core catheter615adjacent its distal tip625. The proximal ends634of the radial implant support arms630normally extend along the core catheter615but are capable of being displaced outward away from the core catheter.

One or more radial support struts636have their proximal ends638pivotably or bendably mounted to the distal end of the actuating catheter610. The distal end640of each radial support strut is636pivotably or bendably attached to a midpoint of a corresponding radial implant support arm630. As the actuating catheter610is advanced with respect to the core catheter615, the radial support struts636force the radial implant support arms630upward and outward in the fashion of an umbrella frame. Thus the actuating catheter610, core catheter615, radial support struts636, and radial support arms630in combination form a deployment umbrella642.

A prosthetic implant645is releasably attached to the proximal ends634of the radial implant support arms630. Around the periphery of the prosthetic implant645and extending-proximally therefrom are a plurality of retention barbs646. In addition, one or more of the radial implant support arms630comprise touchdown sensors648whose proximal ends extend proximal to the implant645. Extending through the central lumen616(FIG. 13) of the core catheter615in the exemplary embodiment600and out lateral ports650(FIG. 12) spaced proximally from the distal tip625are one or more release elements660, which serve to release the implant645from the delivery system, and one or more adjustment elements665which serve to adjust the implant's deployed size and effect. Because the release elements660and adjustment elements665extend through the proximal end of the core catheter615, as seen inFIGS. 14-16, these elements can be directly or indirectly instrumented or manipulated by the physician. A delivery interface670(FIGS.12,16) is defined in this example by the interaction of the deployment umbrella642, the release elements660, and the implant645. In the disclosed embodiment, the release elements660may be a suture, fiber, or wire in a continuous loop that passes through laser-drilled bores in the implant645and in the radial implant support arms630, and then passes through the length of the core catheter615. In such an embodiment, the implant645may be released from the delivery system at a desired time by severing the release element660at its proximal end, outside the patient, and then withdrawing the free end of the release element660through the core catheter610.

FIGS. 14-16show the operation of the implant/delivery system array600, in which an umbrella-like expansion of the prosthetic implant645is achieved by sliding movement of the housing sheath605, the actuating catheter610, and the core catheter615. Referring first toFIG. 14, the housing sheath605is extended to cover the forward ends of the actuating catheter610and core catheter615for intravascular insertion of the implant/delivery system array600. From this starting position, the housing sheath605is retracted in the direction indicated by the arrows662. InFIG. 15the housing sheath605has been retracted to expose the forward end of the actuating catheter610and the collapsed deployment umbrella642. From this position the actuating catheter610is advanced in the direction indicated by the arrows664. This will cause the deployment umbrellas to expand in the directions indicated by the arrows666.FIG. 16shows the expansion of the deployment umbrella642produced by distal motion of the actuating catheter610relative to the core catheter615. After the implant645has been positioned and adjusted to the proper size, the housing sheath605is advanced in the direction indicated by the arrows668to collapse and to cover the deployment umbrella642for withdrawal of the device from the patient.

FIGS. 17 and 18are schematic views illustrating the radial implant support arms630and the radial support struts636of the implant/delivery system array600. InFIG. 17, a radial support strut636is pivotably attached at its proximal end638at a first pivotable joint670to the actuation catheter610. The radial support strut636is attached at its distal end640to a second pivotable joint672at an intermediate point of a corresponding radial implant support arm630. The radial implant support arm630is attached at its distal end632by a third pivotable joint674to the core catheter620.FIG. 17shows the assembly in a closed state. When the actuation catheter610is advanced distally over the core catheter615, as shown by the arrows676, the radial support strut636and the radial implant support arm630are extended by the motion at the first pivotable joint670, the second pivotable joint672, and the third pivotable joint674, as shown by the arrow678. This motion has the effect of expanding the deployment umbrella and folded implant (not shown inFIGS. 17 and 18), allowing it to achieve its greatest radial dimension, prior to engagement and implantation as previously discussed with reference toFIGS. 12-16.

FIGS. 19 and 20show further details of the touchdown sensors648shown previously inFIG. 12. The touchdown sensor648ofFIGS. 19 and 20includes a distal segment680, an intermediate segment682, and a proximal segment684. The distal segment680is spring-mounted, so that it is capable of slidable, telescoping displacement over the intermediate segment682to achieve a seamless junction with the proximal segment684upon maximal displacement. When the touchdown sensor648is in its normal condition, the spring extends the proximal segment such that the sensor assumes the orientation shown inFIG. 19. When the implant645(FIG. 12) is seated against the periphery of an anatomical opening, the proximal segment684of the sensor648is compressed against the distal segment680, as shown inFIG. 20. The distal segment680and the proximal segment684are both constructed of, are sheathed by, or otherwise covered with a radio-opaque material. However, the intermediate segment682is not constructed or coated with such a radio-opaque material. Therefore, when the distal segment680is at rest, it is fully extended from the proximal segment684, and the gap represented by the exposed intermediate segment682is visible on radiographic examination. However, when the distal segment680is brought to maximum closeness with the proximal segment684, no such radio-opaque gap is radiographically visible, and the touchdown sensor is said to be “activated”. This embodiment allows radiographic monitoring of the position of the touchdown sensor648with respect to the degree of extension of the distal catheter segment680. In the embodiment according to the present invention as shown, one or more touchdown detectors648are employed to ascertain that the delivery system for the prosthetic device is located in the proper position to deploy the implant into the mitral annulus. As this anatomic structure cannot be directly identified on fluoroscopy or standard radiographic procedures, such precise location could be otherwise difficult. At the same time, precise localization and engagement of the mitral annulus is critical for proper implant function and safety.

Touchdown detectors within the embodiments according to the present invention can have a multiplicity of forms, including the telescoping, spring-loaded, radio-opaque elements joined by a non-radio-opaque element as in the aforementioned examples. In embodiments employing magnetic resonance imaging, touchdown detectors according to the present invention may utilize metallic segments interposed by nonmetallic segments in a similar telescoping, spring-loaded array. Other embodiments include a visually-evident system with telescoping, spring-loaded elements with color-coded or other visual features for procedures in which direct or endoscopic observation would be possible. Still other embodiments of touchdown detectors according to the present invention include touchdown detectors provided with microswitches at their tips, such that momentary contact of sufficient pressure completes an electrical circuit and signals the activation of the touchdown detector to the operator. Still other touchdown detectors according to the present invention are provided with fiberoptic pathways for Rahmen laser spectroscopy or other spectral analytical techniques which are capable of detecting unique tissue qualities of the tissue at the desired site for implantation. In addition, still other embodiments according to the present invention include touchdown detectors containing electrodes or other electronic sensors capable of detecting and signaling the operator when a desired electrophysiologic, impedance, or other measurable quality of the desired tissue is detected for proper implantation. Such electrophysiologic touchdown detectors may include electrical circuits that produce visual, auditory, or other signals to the operator that the detectors are activated and that the implant is in the proper position for attachment.

In yet other embodiments according to the present invention, other intracardiac or extracardiac imaging techniques including, but not limited to, intravascular ultrasound, nuclear magnetic resonance, virtual anatomic positioning systems, or other imaging techniques may be employed to confirm proper positioning of the implant, obviating the need for the touchdown sensors as previously described.

FIGS. 21-24show an implant700according to one embodiment of the present invention. In this embodiment, the implant body705is bandlike and flexible. Through much of its length, the implant body705is provided with a series of retention barbs710which are oriented to facilitate placement, retention, and removal of the device. The implant body705is also provided with an adjustable section715, which is provided in this example with a series of adjustment stops720. The adjustment stops720may be slots, holes, detents, dimples, ridges, teeth, raised elements, or other mechanical features to allow measured adjustment of the implant700in use. In the embodiment shown inFIGS. 21-24, the adjustment stops720are engaged by a geared connector725.FIG. 21is an end view, showing the implant body705curved on itself, with the retention barbs710to the exterior, and with the adjustable section715passing through its engagement with the geared connector725and curving internally within the implant body705to form a closed, round structure.FIG. 23shows details of an exemplary geared connector725, in which a housing730is connected to the implant body705. The housing730contains and supports a mechanical worm740with an attached first geared head750which mates with a second geared head755. The second geared head755is attached to an adjustment stem760which is machined to receive a screwdriver-like adjustment element. The various embodiments according to the present invention may require a number of forms of adjustment elements. In the present example, the adjustment element is provided as a finely coiled wire with a distal tip machined to be received by a receiving slot in the adjustment stem760(not shown). The relationship between the distal tip of the adjustment element and the adjustment stem760is mechanically similar to a screwdriver bit and screwhead, such that torsion imparted to the adjustment means by the operator will result in the turning of the adjustment stem760and second geared head755allows motion of the first geared head750and worm740, which creates motion of the adjustable implant section715as the worm engages with the series of adjustment tops725. Excess length of the adjustable section715passes though a band slot735(FIG. 23), thus allowing the band to move concentrically inside the closed implant body705. The adjustment element in this embodiment may be designed to remain in place after the deployment umbrella has been retracted and withdrawn. The connection between the adjustment element's distal tip and the adjustment stem760may be a simple friction connection, a mechanical key/slot formation, or may be magnetically or electronically maintained.

As further shown inFIG. 21, the exemplary embodiment employs unidirectional retention barbs710which are attached to the outer perimeter of the implant body705. The retention barbs710are oriented in a consistent, tangential position with respect to the implant body705such that rotational motion of the implant body will either engage or release the retention barbs710upon contact with the desired tissue at the time of deployment. This positioning of the retention barbs710allows the operator to “screw in” the implant700by turning the implant700upon its axis, thus engaging the retention barbs710into the adjacent tissue. As shown inFIG. 24, the retention barbs710may each be further provided with a terminal hook775at the end which would allow for smooth passage through tissue when engaging the retention barbs710by rotating the implant700, without permitting the implant700to rotate in the opposite direction, because of the action of the terminal hooks775grasping the surrounding tissue (much like barbed fish hooks). The terminal hooks775thus ensure the seating of the implant700into the surrounding tissue.

FIGS. 25-27illustrate another embodiment of an implant800as contemplated according to the present invention. The implant800includes a band805(FIG. 27), but the retention barbs of the previous example have been eliminated in favor of an outer fabric implant sheath810. The fabric sheath810can be sutured or otherwise affixed to the anatomic tissue in a desired location. The circumference of the implant body800is adjusted through a geared connector825similar to the geared connector of the bandlike implant array shown inFIG. 23. More specifically, adjustment stops820on the band are engaged by a mechanical worm840with an attached first geared head850. The first geared head850mates with a second geared head855. The second geared head855is attached to an adjustment stem860which is machined to receive a screwdriver-like adjustment element.

FIG. 28illustrates an example of the method of use of an implant/delivery system array600for positioning an implant645in a patient with ischemic annular dilatation and mitral regurgitation. Peripheral arterial access is obtained via conventional cutdown, arterial puncture, or other standard access techniques. After access to the arterial system is attained, guidewire placement is performed and intravascular access to the heart900is obtained using fluoroscopic, ultrasound, three-dimension ultrasound, magnetic resonance, or other real-time imaging techniques. The guidewire, deployment device, and implant are passed through the aortic valve in a retrograde fashion into the left ventricle905and then into the left atrium910. At this point, the operator retracts the housing sheath605, thus unsheathing the collapsed deployment umbrella642and implant645. The deployment umbrella642is then distended by the distal motion of the actuation catheter, causing the radial support arms and struts to fully distend. At this point, the touchdown detectors648are not in contact with any solid structures, and are fully extended with their radiolucent gaps visible on the imaging system. Once the deployment umbrella is distended, the entire assembly is pulled back against the area of the mitral valve915. At least two touchdown detectors648are employed in a preferred embodiment according to the present invention. When all touchdown detectors show the disappearance of their intermediate, non-opaque, intermediate segments and are thus activated, then the deployment umbrella must be in contact with the solid tissue in the region of the mitral annulus/atrial tissue, and further implant deployment and adjustment may proceed. However, if any one touchdown sensor is not activated, and a radiolucent gap persists, then the device is not properly positioned, and must be repositioned before further deployment. Thus, the touchdown sensor system may assist in the deployment and adjustment of prosthetic devices by the delivery system according to the present invention. Once properly positioned, the operator rotates the actuation catheter in a prescribed clockwise or counterclockwise manner to engage the retention barbs on the implant into the tissue in the region of the mitral annulus/atrial tissue. Should re-positioning be required, a reverse motion would disengage the retention barbs from the annular/atrial tissue, and repositioning may be performed, again using the touchdown detectors for proper placement. Once firmly seated, the adjustment element(s) are operated to achieve the desired degree of annular reduction. Real-time trans esophageal echocardiography, intravascular echocardiography, intracardiac echocardiography, or other modalities for assessing mitral function may then be employed to assess the physiologic effect of the repair on mitral function, and additional adjustments may be performed. Once a desired result has been achieved, the release elements are activated to detach the implant from the deployment umbrella. The operator then retracts the actuation catheter and extends the housing sheath, collapsing the deployment umbrella and covering the components for a smooth and atraumatic withdrawal of the device from the heart and vascular system.

If desired, the adjustment elements may be left in position after the catheter components are withdrawn for further physiologic adjustment. In yet other embodiments according to the present invention, a catheter-based adjustment elements may subsequently be re-inserted though a percutaneous or other route. Such an adjustment element may be steerably operable by the operator, and may be provided with magnetic, electronic, electromagnetic, or laser-guided systems to allow docking of the adjustment element with the adjustable mechanism contained within the implant. In still other embodiments, the adjustment mechanism may be driven by implanted electromechanical motors or other systems, which may be remotely controlled by electronic flux or other remote transcutaneous or percutaneous methods.

In the case of pulmonic valve repair, initial catheter access is achieved through a peripheral or central vein. Access to the pulmonary valve is also achieved from below the valve once central venous access is achieved by traversing the right atrium, the tricuspid valve, the right ventricle, and subsequently reaching the pulmonic valve.

In yet other embodiments according to the present invention, catheter access to the left atrium can be achieved from cannulation of central or peripheral veins, thereby achieving access to the right atrium. Then a standard atrial trans-septal approach may be utilized to access the left atrium by creation of an iatrogenic atrial septal defect (ASD). In such a situation, the mitral valve may be accessed from above the valve, as opposed to the retrograde access described in Example 1. The implant and a reversed deployment umbrella may be utilized with implant placement in the atrial aspect of the mitral annulus, with the same repair technique described previously. The iatrogenic ASD may then be closed using standard device methods. Access to the aortic valve may also be achieved from above the aortic valve via arterial access in a similar retrograde fashion.

Other embodiments of the adjustable implant and methods according to the present invention include gastrointestinal disorders such as gastro-esophageal reflux disease (GERD), a condition in which the gastro-esophageal (GE) junction lacks adequate sphincter tone to prevent the reflux of stomach contents into the esophagus, causing classic heartburn or acid reflux. This not only results in discomfort, but may cause trauma to the lower esophagus over time that may lead to the development of pre-cancerous lesions (Barrett's esophagus) or adenocarcinoma of the esophagus at the GE junction. Surgical repair of the GE junction has historically been achieved with the Nissen Fundoplication, an operative procedure with generally good results. However, the Nissen procedure requires general anesthesia and a hospital stay. Utilizing the devices and methods according to the present invention, an adjustable implant would obviate the need for a hospital stay and be performed in a clinic or gastroenterologist's office. Referring now toFIGS. 29 and 30, an umbrella deployment device600with implant645is passed under guidance of an endoscope1000, through the patient's mouth, esophagus1005, and into the stomach1010, where the deployment device600is opened with expansion of the implant645and touchdown detectors648with a color-coded or otherwise visible gap. The touchdown detectors are then engaged onto the stomach around the gastroesophageal junction1015under direct endoscopic control until all touchdown detectors648are visually activated. The implant is then attached to the stomach wall,1020the umbrella642is released and withdrawn, leaving behind the implant645and the adjustment elements. The implant is then adjusted until the desired effect is achieved, i.e., minimal acid reflux either by patient symptoms, pH monitoring of the esophagus, imaging studies, or other diagnostic means. If the patient should suffer from gas bloat, a common complication of gastroesophageal junction repair in which the repair is too tight and the patient is unable to belch, the implant can be loosened until a more desirable effect is achieved.

In various embodiments anticipated by the present invention, the implant body may be straight, curved, circular, ovoid, polygonal, or some combination thereof. In various embodiments anticipated by the present invention the implant may be capable of providing a uniform or non-uniform adjustment of an orifice or lumen within the body. The implant body may further completely enclose the native recipient anatomic site, or it may be provided in an interrupted form that encloses only a portion of the native recipient anatomic site. In still other embodiments of the present invention, the implant body may be a solid structure, while in yet other embodiments the implant body may form a tubular or otherwise hollow structure. In one embodiment of the present invention, the body may further be a structure with an outer member, an inner member, and optional attachment members. In such an embodiment, the outer member of the implant body may serve as a covering for the implant, and is designed to facilitate and promote tissue ingrowth and biologic integration to the native recipient anatomic site. The outer member in such an embodiment may be fabricated of a biologically compatible material, such as Dacron, PTFE, malleable metals, other biologically compatible materials or a combination of such biologically compatible materials in a molded, woven, or non-woven configuration. The outer member in such an embodiment also serves to house the inner member. In this embodiment, the inner member provides an adjustment means that, when operated by an adjustment mechanism, is capable of altering the shape and/or size of the outer member in a defined manner.

In alternate embodiments according to the present invention, the adjustment means may be located external to or incorporated within the outer member. In yet additional alternate embodiments contemplated by the present invention, the implant body may consist of an adjustment means without a separate outer member covering said adjustment means.

In various embodiments according to the present invention, the adjustment means may include a mechanism which may be threaded or non-threaded, and which may be engaged by the action of a screw or worm screw, a friction mechanism, a friction-detent mechanism, a toothed mechanism, a ratchet mechanism, a rack and pinion mechanism, or such other devices to permit discreet adjustment and retention of desired size a desired position, once the proper size is determined.

In yet other embodiments according to the present invention, the adjustment means may comprise a snare or purse string-like mechanism in which a suture, a band, a wire or other fiber structure, braided or non-braided, monofilament or multifilament, is capable of affecting the anatomic and/or physiologic effects of the implant device on a native anatomic recipient site upon varying tension or motion imparted to said wire or fiber structure by a surgeon or other operator. Such an adjustment means may be provided as a circular or non-circular structure in various embodiments. Changes in tension or motion may change the size and/or shape of the implant.

In various embodiments according to the present invention, the adjustment means may be a metallic, plastic, synthetic, natural, biologic, or any other biologically-compatible material, or combination thereof. Such adjustment means may further be fabricated by extrusion or other molding techniques, machined, or woven. Furthermore, in various embodiments of the present invention, the adjustment means may be smooth or may include slots, beads, ridges, or any other smooth or textured surface.

In various embodiments of the present invention, the implant body may be provided with one or more attachment members such as grommets or openings or other attachment members to facilitate attachment of the implant to the native recipient site. In alternate embodiments, the implant body may attach to or incorporate a mechanical tissue interface system that allows a sutureless mechanical means of securing the implant at the native recipient site. In still other alternate embodiments, sutures or other attachment means may be secured around or through the implant body to affix the implant body to the native recipient site. In yet other embodiments of the present invention, mechanical means of securing the implant body to the native recipient site may be augmented or replaced by use of fibrin or other biologically-compatible tissue glues or similar adhesives.

In additional various embodiments according to the present invention, the adjustable implant may be employed to adjustably enlarge or maintain the circumference or other dimensions of an orifice, ostium, lumen, or anastomosis in which a disease process tends to narrow or constrict such circumference or other dimensions.

In various embodiments according to the present invention, an adjustment mechanism may be provided to interact with the adjustment means to achieve the desired alteration in the size and/or position of the adjustment means. Such an adjustment mechanism may include one or more screws, worm-screw arrays rollers, gears, frictional stops, a friction-detent system, ratchets, rack and pinion arrays, micro-electromechanical systems, other mechanical or electromechanical devices or some combination thereof.

In some embodiments as contemplated by the present invention, an adjustment tool may be removably or permanently attached to the adjustment mechanism and disposed to impart motion to the adjustment mechanism and, in turn, to the adjustment means to increase or decrease the anatomic effect of the implant on the native recipient site.

In alternate embodiments according to the present invention, micromotor arrays with one or more micro-electromechanical motor systems with related electronic control circuitry may be provided as an adjustment means, and may be activated by remote control through signals convey by electromagnetic radiation or by direct circuitry though electronic conduit leads which may be either permanently or removably attached to said micromotor arrays.

In still other various embodiments according to the present invention, the adjustment mechanism may be provided with a locking mechanism disposed to maintain the position of the adjustment means in a selected position upon achievement of the optimally desired anatomic and/or physiologic effect upon the native recipient site and the bodily organ to which it belongs. In other embodiments, no special locking mechanism may be necessary due to the nature of the adjustment means employed.

In yet other alternate embodiments according to the present invention, the adjustment means and/or the outer member structure may be a pliable synthetic material capable of rigidification upon exposure to electromagnetic radiation of selected wavelength, such as ultraviolet light. In such embodiments, exposure to the desired electromagnetic radiation may be achieved by external delivery of such radiation to the implant by the surgeon, or by internal delivery of such radiation within an outer implant member using fiberoptic carriers placed within said outer member and connected to an appropriate external radiation source. Such fiberoptic carriers may be disposed for their removal in whole or in part from the outer implant member after suitable radiation exposure and hardening of said adjustment means.

The present invention also provides methods of using an adjustable implant device to selectively alter the anatomic structure and/or physiologic effects of tissues forming a passageway for blood, other bodily fluids, nutrient fluids, semi-solids, or solids, or wastes within a mammalian body. Various embodiments for such uses of adjustable implants include, but are not limited to, open surgical placement of said adjustable implants at the native recipient site through an open surgical incision, percutaneous or intravascular placement of said implants under visual control employing fluoroscopic, ultrasound, magnetic resonance imaging, or other imaging technologies, placement of said implants through tissue structural walls, such as the coronary sinus or esophageal walls, or methods employing some combination of the above techniques. In various embodiments as contemplated by the present invention, adjustable implants may be placed and affixed in position in a native recipient anatomic site by trans-atrial, trans-ventricular, trans-arterial, trans-venous (i.e., via the pulmonary veins) or other routes during beating or non-beating cardiac surgical procedures or endoscopically or percutaneously in gastrointestinal surgery.

Furthermore, alternate methods for use of an adjustable implant device may provide for the periodic, post-implantation adjustment of the size of the anatomic structure receiving said implant device as needed to accommodate growth of the native recipient site in a juvenile patient or other changes in the physiologic needs of the recipient patient.

Adjustment of the adjustable implants and the methods for their use as disclosed herein contemplates the use by the surgeon or operator of diagnostic tools to provide an assessment of the nature of adjustment needed to achieve a desired effect. Such diagnostic tools include, but are not limited to, transesophageal echocardiography, echocardiography, diagnostic ultrasound, intravascular ultrasound, virtual anatomic positioning systems integrated with magnetic resonance, computerized tomographic, or other imaging technologies, endoscopy, mediastinoscopy, laparoscopy, thoracoscopy, radiography, fluoroscopy, magnetic resonance imaging, computerized tomographic imaging, intravascular flow sensors, thermal sensors or imaging, remote chemical or spectral analysis, or other imaging or quantitative or qualitative analytic systems.

In one aspect, the implant/delivery system of the present invention comprises a collapsible, compressible, or distensible prosthetic implant and a delivery interface for such a prosthetic implant that is capable of delivering the prosthetic implant to a desired anatomic recipient site in a collapsed, compressed, or non-distended state, and then allowing controlled expansion or distension and physical attachment of such a prosthetic implant by a user at the desired anatomic recipient site. Such a system permits the delivery system and prosthetic implant to be introduced percutaneously through a trocar, sheath, via Seldinger technique, needle, or endoscopically through a natural bodily orifice, body cavity, or region and maneuvered by the surgeon or operator to the desired anatomic recipient site, where the delivery system and prosthetic implant may be operably expanded for deployment. When desirable, the implant/delivery system according to the present invention is also capable of allowing the user to further adjust the size or shape of the prosthetic implant once it has been attached to the desired anatomic recipient site. The delivery system according to the present invention is then capable of detaching from its interface with the prosthetic implant and being removed from the anatomic site by the operator. The delivery system and prosthetic implant may be provided in a shape and size determined by the anatomic needs of an intended native recipient anatomic site within a mammalian patient. Such a native recipient anatomic site may be a heart valve, the esophagus near the gastro-esophageal junction, the anus, or other anatomic sites within a mammalian body that are creating dysfunction that might be relieved by an implant capable of changing the size and shape of that site and maintaining a desired size and shape after surgery.

In various embodiments contemplated by the present invention, the delivery system may be a catheter, wire, filament, rod, tube, endoscope, or other mechanism capable of reaching the desired recipient anatomic site through an incision, puncture, trocar, or through an anatomic passageway such as a vessel, orifice, or organ lumen, or trans-abdominally or trans-thoracically. In various embodiments according to the present invention, the delivery system may be steerable by the operator. The delivery system may further have a delivery interface that would retain and convey a prosthetic implant to the desired recipient anatomic site. Such a delivery interface may be operably capable of distending, reshaping, or allowing the independent distension or expansion of such a prosthetic implant at the desired recipient anatomic site. Furthermore, such a delivery interface may provide an operable means to adjust the distended or expanded size, shape, or physiologic effect of the prosthetic implant once said implant has been attached in situ at the desired recipient anatomic site. In various embodiments according to the present invention, such adjustment may be carried out during the procedure in which the implant is placed, or at a subsequent time. Depending upon the specific anatomic needs of a specific application, the delivery interface and the associated prosthetic implant may be straight, curved, circular, helical, tubular, ovoid, polygonal, or some combination thereof. In still other embodiments of the present invention, the prosthetic implant may be a solid structure, while in yet other embodiments the prosthetic implant may form a tubular, composite, or otherwise hollow structure. In one embodiment of the present invention, the prosthetic implant may further be a structure with an outer member, an inner member, and optional attachment members. In such an embodiment, the outer member of the prosthetic implant may serve as a covering for the implant, and is designed to facilitate and promote tissue ingrowth and biologic integration to the native recipient anatomic site. The outer member in such an embodiment may be fabricated of a biologically compatible material, such as Dacron, PTFE, malleable metals, other biologically compatible materials or a combination of such biologically compatible materials in a molded, woven, or non-woven configuration. The outer member in such an embodiment also serves to house the inner member. In this embodiment, the inner member provides an adjustment means that, when operated by an adjustment mechanism, is capable of altering the shape and/or size of the outer member in a defined manner.

In some embodiments according to the present invention, at least some portions of the adjustable inner or outer member may be elastic to provide an element of variable, artificial muscle tone to a valve, sphincter, orifice, or lumen in settings where such variability would be functionally valuable, such as in the treatment of rectal incontinence or vaginal prolapse. In various embodiments according to the present invention, the delivery interface would have an attachment means to retain and convey the prosthetic implant en route to the native anatomic recipient site and during any in situ adjustment of the prosthetic implant once it has been placed by the operator. Such an attachment means would be operably reversible to allow detachment of the prosthetic implant from the delivery interface once desired placement and adjustment of the prosthetic implant has been accomplished.

In one embodiment of the present invention, illustrated inFIG. 31, an implantable device system1000for controlling at least the size or shape of an anatomical structure or lumen includes an implantable device1002and an adjustment tool1006. The anatomical structure or lumen is an anatomic site with dysfunction that can be relieved by the implantable device1002to change a size or shape of the anatomic site.

FIG. 32Ais a schematic of the implant device1002without showing an optional flexible outer tube and fabric sheath.FIG. 32Bis a schematic of a disassembled portion of implantable device1002with retaining tube1015removed.

In another embodiment of the present invention, illustrated inFIGS. 33 through 36, the adjustable member1004provides translated motion through rotation.FIGS. 33 through 35illustrate a theory of operation of an embodiment of the present invention, whileFIG. 36shows details of the adjustment member1004.

FIG. 37provides a schematic view of portions of elements of a system1011having features of the invention including an adjustable implant tdevice1012, an adjustment tool,1014, and an adjustable implant device positioning element1016. As illustrated inFIG. 37, an adjustable implant device1012having features of the invention has an adjustment member1018configured to engage an adjustment too1014, the adjustment member1018having an adjustment tool coupler1019which serves as the interface between an adjustment tool1014and an adjustment member1018. An adjustment tool coupler1019may include a slot or other receptacle to receive an end of an adjustment tool1014, or may have a protuberance such as a ridge, a tee-shape, a hexagonal shape, or other engagement element configured to mate with and engage an adjustment tool1014. An adjustable implant device1012has a perimeter, such as a perimeter1021as indicated inFIG. 37, or other perimeter associated with a substantially circumferential dimension. A perimeter1021or other perimeter may be adjusted (e.g., increased or decreased in magnitude) by operation of an adjustment tool1014engaged with an adjustment tool coupler. It will be understood that an adjustable implant device1012has additional dimensions, configurations, and orientations, some or all of which may be adjusted or altered by an operator, such as by using an adjustment tool1014, during use of the device.

Also illustrated in the system1011shown schematically inFIG. 37is an adjustable implant device holding element1022, illustrated as a plurality of elongated structures1024which attach to the adjustable implant device1012(as indicated by small circles spaced around the adjustable implant device1012) effective to hold the adjustable implant device1012during its, and effective to release the adjustable implant device1012upon its fixation to target tissue. The elongated structures1024may be struts, or columns, or other supporting structures configured to move and guide an adjustable implant device1012to a desired location, preferably under the direction and control of an operator. The elongated structures1024may also serve as housings or guides for securing elements1026configured to attach and to hold an adjustable implant device1012to tissue. In the embodiment illustrated inFIG. 37, the adjustable implant device holding element1022, made up of a plurality of elongated structures1024, forms a virtual enclosure1028which surrounds an implant device positioning element1016, shown inFIG. 37as a whisk shape made up of a plurality of thin flexible elements1030, such as tines, wires or flexible rods. Each tine may be made with a compliant material that allows the structure to be easily collapsed to a contracted configuration, for example, under the influence of an external constraint or force, yet allows ready expansion to an expanded configuration when external constraint is removed.

In embodiments of systems1011having features of the invention, securing elements1026may be housed, during initial placement of an adjustable implant device1012, within elongated structures1024that are hollow, and then may be deployed from within the hollow elongated structures1024effective to secure the adjustable implant device1012to tissue. It will be understood that, in embodiments, a securing element1026may be disposed on, or around an adjustable implant holding element1022, and need not be housed within an adjustable implant holding element1022which serves as a securing element housing1024. Securing elements1026may engage an adjustable implant device1012by passing through the device1012(e.g., passing through a fabric coating of the device1012), or through elements of the device1012(e.g., passing through rings or eyelets of the device1012), or may enclose or compress a device1012in order to secure it to tissue. Securing elements1026may pass into tissue, and adhere to tissue by their shape, with barbs, or hooks, and may pass into and then out of tissue effective to adhere to, or attach to, tissue. Securing elements1026may be made of a single material or composition, such as a resilient material effective to pierce and penetrate tissue, and to assume a non-linear shape within tissue; may include a staple or hook portion; or may have separate elements, such as, for example, a needle or hook portion and a suture or thread portion. In embodiments of the systems, devices and methods having features of the invention, securing elements1026may assume shapes selected from a curve, a loop, a coil, a spiral coil, a barb, a bifurcation, and an anchor shape.

The virtual enclosure1028, made up of elongated structures1024, which surrounds an implant device positioning element1016, may have its shape maintained by an implant holding element guide1032. An implant holding element guide1032having features of the invention is configured to support and guide the elongated structures1024that are part of the adjustable implant holding element1022. An implant holding element guide1032may have an aperture1034for passage of a positioning element1016. As illustrated inFIG. 37, an adjustable implant holding element1022may have a handle1036for manipulation and control of the adjustable implant holding element1022and of the adjustable implant device1012.

An adjustment tool1014has a tool shaft1038for control of the adjustment tool1014by an operator or by operating machinery positioned at a distance from the adjustable implant device1012. An adjustable implant holding element1022may have a tool guide1040, for example, as illustrated in the embodiment shown inFIG. 37, a loop enclosing a portion of tool shaft1038to constrain movement of the tool shaft1038without constraining its rotation or ability to move or be displaces along longitudinal directions. A handle1042allows manipulation and control of an adjustment tool1014. A tool shaft1038may be solid, or may be hollow. A hollow tool shaft1038may enclose a tool internal element1044, which may be a rotary element, effective to allow rotation of a tool tip portion1046. A tool tip portion1046may be configured to engage with an adjustment member1018, for example by means of engaging with an adjustment tool coupler1019, and may have elements, or a shape, configured to engage complementary elements or shapes on an adjustment tool coupler1019. A tool internal element1044may include wires, cables, hydraulic, pneumatic, or other coupling elements effectivelo control a tool tip portion1046effective that the tip portion1046may cause or guide the operation of an adjustment tool coupler1019to effect the operation of an adjustment member1018effective to adjust an adjustable implant device1012.

In embodiments, an implant holding element1022may have a handle1036with a securing element control1048or a plurality of securing element controls1048. A securing element control1048may be configured, for example, to deploy a securing element1026from within a housing1024effective that the securing element1026secures an adjustable implant device1012to tissue. For example, as illustrated inFIG. 37, a securing element control1048may be a slider disposed on a handle1036and operably connected with an internal element1049effective to deploy a securing element1026. For example, an internal element1049may be a plunger, connected with control1048that may move longitudinally within a housing1024and push on a securing element1026housed within the housing1024. Such a securing element1026may be, for example, a stressed, pointed wire housed within housing1024which, upon exiting the housing1024penetrates tissue and assumes a coiled configuration effective to hold the tissue and to enclose an adjustable implant device1012, securing the adjustable implant device1012to the tissue.

A tool guide1040may be configurable between different configurations. For example, in embodiments, a tool guide1040may assume a holding position and may assume a releasing position. A tool guide control1050, which may be disposed on a handle1036as illustrated inFIG. 37, may be provided in order to control the configuration of a tool guide1040. A tool guide control1050may be operably connected with a tool guide1040effective to open or close a loop, where a tool guide1040includes a loop through which a tool shaft1038passes. In other embodiments, a tool guide control1050may be operably connected with an element, such as a magnetic element, where a tool guide1040comprises a coupling, such as a magnetic coupling, configured to guide a tool shaft1038, effective to engage or disengage the tool guide1040with the tool shaft1038.

An implant holding element guide1032having an aperture1034may be effective to guide and direct a positioning element1016during operation of the positioning element. A positioning element1016may be used to guide an adjustable implant device1012to a desired position adjacent an anatomical orifice or lumen. In embodiments, where, for example, a target anatomical orifice or lumen is a heart valve such as a mitral valve, an implant holding element guide1032may aid in directing the adjustable implant device1012to a position adjacent tissue surrounding the heart valve, such as the mitral valve, effective that the adjustable implant device1012may be secured to tissue adjacent the valve and effective that the adjustable implant device1012adjust and improve the function of the valve.

Operation of a handle1036to position, orient, or reconfigure an adjustable implant holding element1022and an adjustable implant holding element guide1032allows an operator to position an adjustable implant positioning element1016and so to position an adjustable implant device1012in desired orientations and positions. In embodiments, for example, a positioning element1016may be disposed to pass through an aperture1034in an implant holding element guide1032, the configuration of the aperture1034and the guide1032being effective to guide positioning element1016, and to constrain or direct its lateral (or radial) movement while allowing movement or displacement in a longitudinal direction. As is discussed in the following, longitudinal displacement of the positioning element1016distal to the adjustable implant device1012allows placement of a distal portion1017of a positioning element1016adjacent to, or within, an anatomical orifice or lumen. Such placement of a distal portion1017of a positioning element1016serves to guide subsequent placement of an adjustable implant device1012into proper position adjacent a target anatomical orifice or lumen, such as a heart valve, e.g., a mitral valve.

As shown inFIG. 37, a positioning element1016may have a whisk shape made up of a plurality of thin flexible elements1030, such as wires or flexible rods. In embodiments, a positioning element1016may have a fenestrated surface, such as a plurality of holes or apertures, or be made from a mesh, or made from an interlocking network of material. Such holes or apertures may include covers configured to allow fluid flow in at least one direction. Thus, in embodiments, a positioning element1016may be configured to allow passage of fluid, such as blood or other physiological fluid, including artificial physiological fluids, through the surface defined by the material making up positioning element1016. A positioning element1016is configured for placement at a desired location within a heart, a blood vessel, or other anatomical location in which fluid may flow, and may be configured to allow fluid flow while in place at that anatomical location. While allowing fluid flow, a positioning element1016may also configured to interact with tissue so as to guide the positioning of an adjustable implant device1012to a desired position adjacent a target anatomical orifice or lumen.

Thus, for example, a positioning element1016carrying an adjustable implant device1012, as illustrated inFIG. 37, may be positioned within a heart atrium, such as a left atrium; a distal portion1017of the positioning element1016may be placed within a heart valve, such as a mitral valve, displacing valve leaflets while allowing blood flow through the valve while the distal portion1017of the positioning element1016is in place within the valve. Interaction of such a positioning element1016with the valve and adjacent tissue is effective to position the adjustable implant device1012at a desired position in contact with valve tissue and/or tissue adjacent the valve. The placement of a distal portion1017of the positioning element1016may thus be effective to guide and position the adjustable implant device1012to a desired position effective that the adjustable implant device is positioned for repair or improvement of function of the valve. When so positioned, the adjustable implant device1012may be secured to tissue, may be adjusted for optimal improvement of valve function, and the positioning device1016and other elements of a system1011having features of the invention may be removed, leaving the adjustable implant device1012, securing elements1026, and optionally other elements in place effective to control the shape of the valve. Such control of the shape of the valve is effective to improve the operation and function of the valve, and, where necessary, to repair the valve to restore or improve its function. It will be understood that similar actions using systems1011having features of the invention may be performed with other valves, including valves not in the heart, and with other anatomical orifices and lumens, including anatomical orifices and lumens in the gastrointestinal system and in other organ systems.

In embodiments of devices1012and systems1011having features of the invention, a positioning element1016may be configured so that fluid flow itself may aid, guide, or control the positioning of a device1012to a desired position adjacent a target anatomical orifice or lumen. Thus, a positioning element1016may be configured so that flow or passage of fluid, such as blood or other physiological fluid, including artificial physiological fluids, towards or through the surface defined by the material making up positioning element1016is effective to urge, guide, or position a positioning element1016towards and/or at a desired location within a heart, a blood vessel, or other anatomical location in which fluid may flow. As discussed above, a positioning element1016may be configured to allow fluid flow while in place at that anatomical location. While allowing fluid flow, a positioning element1016may also configured to interact with tissue so as to guide the positioning of an adjustable implant device1012to a desired position adjacent a target anatomical orifice or lumen. Thus, a positioning element1016may be configured so that contact of the positioning element1016with tissue, or flow or passage of fluid, or both, may be effective to urge, guide, or position a positioning element1016towards and/or at a desired location within a heart, a blood vessel, or other anatomical location in which, or towards which, fluid may flow.

As illustrated inFIG. 38, an adjustable implant device1012disposed around a positioning element1016, and having an adjustment tool1014operably connected with the adjustment member1018of the adjustable implant device1012, may assume different configurations having different sizes. For example, as shown inFIG. 38, an adjustable implant device1012may assume a configuration with a reduced diameter and a reduced perimeter (e.g.,FIG. 38A) and may assume a configuration with an increased diameter and a increased perimeter (e.g.,FIG. 38B). As is also illustrated inFIGS. 38A, B, and C, an adjustable implant device1012disposed around a positioning element1016may be moved, or may assume different positions, along a longitudinal dimension of the positioning element1016. Longitudinal movement of the adjustable implant device1012is indicated inFIG. 38Bby straight arrows pointing to the right in the figure; radial increase in the size of the adjustable implant device1012is indicated by straight arrows pointing in vertical directions inFIG. 38C. It will be understood that longitudinal movement may be in the opposite direction as the direction shown inFIG. 38B, and that radial size changes may be to decrease the size of an adjustable implant1012, opposite to that illustrated inFIG. 38C. It will be further understood that an adjustable implant device1012having features of the invention may not have a circular configuration, but may have other shapes and orientations than the exemplary one illustrated in the figures, and that size changes may not be radial changes alone, but may include orientation, angular changes, non-planar changes, asymmetrical changes, breaks or discontinuities, and other alterations of the size, shape, orientation, and configuration of an adjustable implant device1012having features of the invention.

Operation of tool1014may be effective to adjust a size and/or a shape of the adjustable implant device1012. For example, operation of tool1014may be effective to adjust a size (e.g., the diameter and the perimeter) of the adjustable implant device1012. Operation of tool1014may be effective to adjust a shape of the adjustable implant device1012(e.g., asymmetric actions, such a reduction in a dimension so that one side and not the other side of the adjustable implant device1012is shortened, so that a perimeter is reduced while one side of the adjustable implant device1012is unchanged or changed by a lesser amount than the other side). In embodiments, adjustment of an adjustable implant device1012is effected by operation of a tool1014engaged with an adjustment member1018, typically via an adjustment tool coupler1019. Operation of tool1014is indicated by the curved arrow inFIG. 38C. A tool1014may have a shaft1038guided by a tool guide1040, as illustrated inFIGS. 38A, B, and C. In alternative embodiments, there is no tool guide1040. Operation of a tool1014may be by rotation, effective to rotate a shaft1038or an internal element1044, or may be by other means of effecting adjustment of an adjustable implant device1012.

An adjustable implant device1012may be secured to tissue by any suitable means, including by sutures, staples, clips, adhesives, grafts, or other attachment means. Any suitable means known in the art may be used to secure an adjustable implant device1012in place effective to adjust a dimension of an anatomic orifice or lumen. Examples of securing devices suitable for securing an adjustable implant device1012are shownFIG. 39. A securing element1026may have a tip portion1052, a medial portion1054and a proximal portion1056. A securing device1026may be configured to be delivered to an anatomic site by a system1011, such as, e.g., by being carried within a housing1024, or by being carried on a surface of a holding element1022. In embodiments, a securing element1026may assume a particular configuration within a housing1024, and may assume a different configuration outside of the housing1024. A securing element1026may include a resilient material and may assume a first configuration, such as a substantially linear configuration, within a housing due to the physical constraint of the housing1024, and may assume an unstrained, non-linear second configuration when disposed outside of the housing1024. In embodiments of securing elements1026having features of the invention, a securing element1026may include shape memory materials, or composites such as bimetallic strips, that alter shape upon changes in environmental conditions.

For example, in embodiments, a securing element1026may be constrained into a straight configuration within a housing1024, as illustrated inFIG. 39A, and may be configured to assume a curved configuration outside of the housing1024, as illustrated inFIG. 39B. For example, a securing element1026may be a spring clip or other deformable holding element, which may be loaded within a housing1024and ejected from a housing1024by a pushrod or plunger1049. Such a securing element1026may be pre-shaped to have a curved, coiled, barbed, or other shape when free of constraint, and may be able to assume a straight or other shape suitable for placement within a housing1024. As illustrated in the examples shown inFIGS. 39A and 39B, a securing element1026may be disposed within a distal portion of a housing1024, and may be displaced outwardly of a port1051from the housing1024by action an internal element1049(shown here as a plunger1049). In embodiments, an internal element1049within a housing1024contacts a proximal portion1056of a securing element1026and pushes it longitudinally effective to cause the tip portion1052to exit the port1051. As indicated inFIG. 39B, tip portion1052may assume a non-linear configuration after exiting port1051. Further longitudinal displacement of a plunger1049causes further longitudinal displacement of the securing element1026, and a greater amount of the securing element1026, including a medial portion1054as well as tip portion1052, emerges from port1051, and the securing element1026assumes further curvature, as illustrated in the example shown inFIG. 39C. As illustrated in the example ofFIG. 39D, further longitudinal advancement of plunger1049causes further longitudinal displacement of the securing element1026, so that the entire securing element1026, including proximal portion1056, is pushed out of port1051, fully deploying the securing element1026, which is shown having assumed the configuration of a substantially closed curve (e.g., a substantially closed ring).

In embodiments, a tip portion1052includes a sharp portion suitable for penetrating tissue. As a securing element1026is displaced longitudinally from a housing1024, a tip portion1052may penetrate tissue. In embodiments, as a securing element1026is displaced longitudinally from a housing1024, a tip portion1052may pass through or penetrate at least a portion of an adjustable implant device1012. In embodiments, as a securing element1026is displaced longitudinally from a housing1024, a tip portion1052may pass through or penetrate at least a portion of an adjustable implant device1012and may penetrate tissue.

It will be understood that a securing element1026may assume any configuration suitable for attaching to tissue, including, for example, needles, needles with suture, barbs, hooks, and other penetrating and attaching shapes. Examples of configurations of a securing element1026having features of the invention and suitable for attaching to tissue include curved, looped, spiral coiled, barbed, bifurcated, hooked, and anchor-shaped configurations. A securing element1026having features of the invention may have any suitable cross-sectional configuration. As illustrated inFIGS. 39L, M and N, which provide partial cross-sectional views of housings1024and securing elements1026, and showing the securing elements1026within the housings1024, the cross-sectional shape of a securing element1026(as taken along the line LMN-LMN shown inFIG. 39A) may be, e.g., circular, square, or triangular. Other cross-sectional shapes, including oval, ridged, clover-shaped, or other shapes may also be used for securing elements1026having features of the invention. The cross-sectional shape may aid the securing element1026to assume the proper configuration upon exit from the housing1024, and may aid in orienting the securing element1026in proper position or orientation upon exit from the housing1024. Securing elements1026may be made of any suitable material, including, for example, metal, composite, plastic, shape-memory material such as a shape-memory metal (e.g., nitinol), or mixtures, alloys and combinations thereof.

FIGS. 40A-Gillustrate one method of attachment of an adjustable implant device1012to tissue1058. These figures show penetration by a securing element1026of a portion of adjustable implant device1012, of tissue surface1072and advancement into adjacent tissue1058(FIGS. 40A-D). Note the curvature of the securing element1026within the tissue1058shown in these figures. Further advancement of the securing element1026through the adjustable implant device1012and tissue1058, and further curvature of the securing element1026, leads to exit of tip portion1052from tissue surface1072, as illustrated inFIG. 40E. Due to its curvature, tip portion1052exits tissue1058from the same tissue surface1072through which it entered tissue1058. Still further advancement of the securing element1026through the adjustable implant device1012and tissue1058, and further curvature of the securing element1026, leads to additional contact with, and penetration of, the adjustable implant device1012, as illustrated inFIGS. 40Fand G. Note that a smaller and smaller portion of the securing element1026remains within housing1024as plunger1049advances to push securing element1026in a distal direction. As indicated inFIGS. 40Fand G, advancement of plunger1049may be effective to push securing element1026completely out of housing1024and to deploy securing element1026. In the configuration shown inFIG. 40G, securing element1026is deployed from the housing1024, and is thus free of the adjustable implant holding element1022, and is configured effective to secure the adjustable implant device1012to tissue1058. As indicated byFIG. 40F, a securing element1026may include a tip portion1052that may curve back sufficiently to approach the surface of an adjustable implant device1012after having penetrated the adjustable implant device1012and tissue1058to secure the adjustable implant device1012to the tissue1058. As indicated byFIG. 40G, a securing element1026may include a tip portion1052that may curve back even further than as shown inFIG. 40F, so as to re-enter the surface of an adjustable implant device1012after having penetrated the adjustable implant device1012and tissue1058to secure the adjustable implant device1012to the tissue1058. Either configuration is effective to secure an adjustable implant device1012to the tissue1058.

An adjustable implant device1012may be configured for penetration by a securing element1026. For example, an adjustable implant device1012may have a passage element1060configured to accept a securing element1026and allow its passage therethrough, while retaining the securing element1026effective that the securing element1026is attached to the adjustable implant device1012. A passage element1060may be, for example, an eyelet, loop, hook, grommet, or other passage element1060. An adjustable implant device1012may be configured for penetration by a securing element1026and have an outer portion1062and an inner portion1064, where the outer portion1062is configured to accept passage of a securing element1026while remaining attached to inner portion1064. An adjustable implant device1012may be configured for penetration by a securing element1026by being made of a suitable material, such as a soft or spongy material or composition able to be penetrated without minimal or localized breakage or tearing due to the penetration, and may be made of a resilient material that adheres or regains shape to closely adhere to penetrating material. For example, a soft rubber or plastic material that encloses or accompanies wire, fabric, plastic threads or fibers, or any suitable circumferential elements may be able to be penetrated yet maintain physical properties such as its shape and strength. In embodiments, an adjustable implant device1012may be configured for penetration by a securing element1026by having a coating of, or being enclosed by, cloth, fabric, mesh, netting, web, coils, threads, or other material or materials able to be penetrated by a securing element1026while retaining their hold or their enclosure of the adjustable implant device1012. In embodiments, an adjustable implant device1012may have passages, or loops, or eyelets, or other elements configured to allow passage of a securing element1026and to allow the securing element1026to secure the adjustable implant device1012to tissue1058.

As discussed above, an adjustable implant device1012may include a mesh, fabric, net, knit, woven, or other coating or outer layer. Such a coating or outer layer may be suitable for passage of a securing element1026effective that the securing element pass though the coating or outer layer and engage the adjustable implant device1012effective to secure the adjustable implant device1012to tissue when the securing device1026is engaged with tissue. Suitable materials for a coating or outer layer include, for example, e.g., polyethylene, polyester, polyethylene terephthalate, polyolefin, nylon, Dacron®, Teflon®, and other biocompatible materials, and may include biologically compatible fabric, biologically compatible mesh, biologically compatible knit, biologically compatible netting, or other materials or compositions. In embodiments, materials and coatings include materials and coatings that allow or enhance tissue overgrowth after placement of the device in a patient's body. In embodiments, materials and coatings include anti-thrombogenic materials and coatings that decrease risk of thrombosis after placement of the device in a patient's body.

In embodiments of adjustable implant devices1012having features of the invention, an adjustable implant device1012may have an outer polyester coating, such as an outer polyester sewing cuff, that allows easy tissue overgrowth after placement of the device in a patient's body. Underneath the outer polyester coating may be, for example, an optional silicone sheath or layer that provides purchase for the physician as the physician applies suture or as the securing elements1026are applied. In embodiments, a silicone sheath or layer may be made with a silicone that is adapted to allow a securing element1026to properly recover its original (curved) shape, such as a soft silicone. A soft silicone sheath or layer further provides the advantage of allowing greater flexure of the securing element1026within the adjustable implant device1012. In further embodiments, there is no silicone sheath or layer.

FIGS. 41A-Dare sequential illustrations of another method of securing an adjustable implant device1012to tissue1058. As illustrated in these figures, in this method a securing element1026penetrates tissue1058, and curves within tissue1058, but does not penetrate an adjustable implant device1012. Instead, a securing element1026curves around an adjustable implant device1012, encircling and holding the adjustable implant device1012effective to secure it to the tissue1058. A securing element1026having features of the invention as illustrated inFIGS. 41A-Dcurves around an adjustable implant device1012in order to secure the adjustable implant device1012. Increasing amounts of advancement of the securing element1026out of housing1024lead to increasing amounts of curvature of the securing element1026. As indicated inFIG. 41D, advancement of plunger1049may be effective to push securing element1026completely out of housing1024and to deploy securing element1026, effective to secure the adjustable implant device1012to tissue1058. It will be understood that either one, or both, of the methods illustrated inFIG. 40andFIG. 41may be used to secure an adjustable implant device1012to tissue1058.

FIGS. 42A-Iare a series of schematic partial cross-sectional illustrations showing deployment of a securing element1026from a housing1024to secure an adjustable implant device1012to tissue1058.FIGS. 42A-Iare similar toFIGS. 40A-G, in that these figures show penetration by a securing element1026of a portion of adjustable implant device1012, advancement of the securing element1026into adjacent tissue1058with increasing amounts of curvature of the securing element1026within the tissue1058as it advances. Further advancement and further curvature leads to exit of tip portion1052from tissue surface1072, and additional penetration of the adjustable implant device1012, securing the adjustable implant device1012to tissue. However,FIGS. 42A-Iinclude additional elements, including a housing retention device1066. Housing retention device1066is illustrated inFIGS. 42A-Ias an anchor-shaped hook, however it will be understood that any suitable retention device1066effective to maintain contact between implant holding element1022(e.g., housing1024) and adjustable implant device1012during securing of the adjustable implant device1012to tissue1058, yet to allow separation of holding element1022(e.g., housing1024) from the adjustable implant device1012once the adjustable implant device1012has been secured to tissue1058may be used in the systems, devices and methods having features of the invention.

As shown inFIG. 42Aan adjustable implant holding element1022(that is also a securing element housing1024), having a securing element1026disposed within the housing1024, may also have a retention element1066having grasping elements1068(shown here as retention element hooks1068) which releasably secure the housing1024to the adjustable implant device1012.FIGS. 42B and 42C show penetration of the implant device1012by the securing element1026, andFIGS. 42D, E, and F show penetration of tissue1058by the securing element1026, which curves as it advances, effective to secure the implant device1012to tissue1058. As illustrated inFIG. 42F, securing element1026may curve sufficiently to exit tissue1058from the same tissue surface1072through which it initially entered tissue1058, and re-connect with implant device1012, strongly securing implant device1012to tissue1058.

FIGS. 42G, H, and I are sequential illustrations showing further steps in which the housing1024is retracted from the implant device1012, the retention element1066deforming as the housing1024is retracted, allowing the housing1024to separate from the implant device1012effective to deploy the implant device1012and leave it secured to tissue1058by securing element1026and free of holding element1022(housing1024). An operator may control such operations by hand, using handles1036, or other control elements. For example, retraction of retention element hooks1068may be controlled by a manually operated handle. In further embodiments, retention element hooks1068are resilient, and deform and release under sufficient force; or may release upon rotation but not upon longitudinal stress; may be made with shape memory materials; may be magnetic; may be configured to release with heat, applied electricity, or other signal; or may be otherwise configured to maintain connection between an adjustable implant device1012and a holding element1022.

FIGS. 43A-Dprovide a partial schematic side-view of an implant device positioning element1016and its use within a heart valve. As shown in these figures, an implant positioning device1016may be in the configuration of a whisk1016. Such a whisk1016may be made up of several strands of flexible material, such as flexible wire-shaped material, including flexible metal wires, flexible plastic wires, flexible polymer wires, flexible carbon fiber wires, or other suitable materials. A schematic side view of portions of an exemplary whisk-shaped implant positioning device1016is shown inFIG. 43Awith the distal portion1017in an expanded configuration. As indicated inFIG. 43B, a distal portion1017of an implant positioning device1016may also assume a contracted or compressed configuration. The implant positioning device1016shown inFIG. 43Bis shown in cross-section disposed within a trocar1074suitable for delivery of an implant positioning device1016to a position near a target anatomical orifice or lumen, and near target tissue. The implant positioning device1016shown inFIG. 43Bis shown in a contracted configuration. The implant positioning device1016shown inFIG. 43Cis shown in an expanded configuration. The vertical arrows inFIG. 43Cindicate radial expansion directions.

An implant positioning device1016may be resilient, and may expand upon exit from a trocar1074without further action or control. Thus, for example, an implant positioning element1016may expand from a contracted configuration assumed within a trocar1074to an expanded configuration (for the portion outside a trocar1074) when advanced so that a distal portion1017as a result of the resiliency of the materials with which the implant positioning element1016is made. In embodiments, an implant positioning device1016may expand only under the control of an operator, or an automatic control mechanism. For example, an implant positioning device1016may be resilient, yet may include a stop or control effective to maintain the implant positioning device1016in a contracted configuration even when a portion or when all of an implant positioning device1016is disposed outside a trocar1074or other housing or delivery device. Alternatively, an adjustable implant device1016may be made of materials which would not normally expand into an expanded configuration after having been compressed or constrained, but may be configured with expansion mechanisms, such as gears, levers, springs, slides, or other mechanical, hydraulic, pneumatic, electric, magnetic, or other expansion elements. Upon release of such a stop, or activation of such a control, an implant positioning device1016, or a distal portion of an implant positioning device1017, may then assume an expanded configuration.

Thus, in embodiments of the systems, devices and methods having features of the invention, an implant positioning device1016may be made of a spring material, or other resilient material effective that it may collapse upon placement within a trocar1074, but will rebound to expand to a larger diameter shape upon release from within the trocar1074. In other embodiments, an implant positioning device1016may be made of any material, including non-resilient materials, that will allow it to be collapsed and place within a trocar1074, and will allow it to be expanded to a larger diameter shape upon exit from within the trocar1074, but such expansion may be achieved with the aid of external force or operation of additional tools or mechanisms, and need not be due to the resiliency of the material. For example, an implant positioning device1016may be operably connected to an adjustable implant device1012, and its connection to the adjustable implant device1012may result in adjustment of the diameter of the positioning device1016in concert with, and due to, the adjustment of the diameter of the adjustable implant device1012.

A schematic example of the operation of an implant positioning device1016is shown in a partial schematic cross-sectional side view inFIG. 43D. In that figure, a schematic representation of a cross-section of a human mitral valve1076is shown with portions of a left atrium1078and of a left ventricle1080adjacent the valve1076. The tissue1058immediately adjacent the human mitral valve1076is the mitral valve annulus1086, which defines a valve plane1088substantially perpendicular to the flow path of blood through the valve1076. The figure shows the mitral valve leaflets1082displaced by the implant device positioning element1016which is shown with a distal portion1017disposed within the valve orifice1084. The distal portion1017of the implant device positioning element1016has expanded to substantially fill the valve orifice1084effective to substantially center the implant device positioning element1016within the mitral valve1076. Placement of a distal portion1017of an implant device positioning element1016within a valve1076is also effective to displace valve leaflets1082away from tissue1058so that valve leaflets1082will not be in the way, and will not be injured during placement and securing of an adjustable implant device1012to tissue1058adjacent a valve1076. In addition, placement of a distal portion1017of an implant device positioning element1016within a valve1076and displacement of valve leaflets1082away from tissue1058also insures that valve leaflets1082will not be secured to tissue, or trapped by, an adjustable implant device1012due to securing an adjustable implant device1012to tissue1058adjacent a valve1076. The implant device positioning element1016has sufficient open space to allow blood flow through the implant device positioning element1016and through the valve1076while the implant device positioning element1016is in place within a valve1076.

In embodiments of the methods of using the systems and devices disclosed herein, an adjustable implant device1012may be mounted on, attached to, or otherwise carried with an implant positioning element1016, as shown, for example, inFIG. 44A. In that figure, showing cross-sectional views, an implant device positioning element1-16is shown in the whisk embodiment, such as a whisk-shape made of flexible wire-shaped material, and carrying an adjustable implant device1012. A similar view of these elements is provided inFIG. 44B, showing the implant device positioning element1016and the adjustable implant device1012disposed adjacent a human mitral valve1076within a left atrium1078(shown in schematic cross-sectional view). The left ventricle1080is shown at the right inFIGS. 44B and 44C. The implant device positioning element1016carrying the adjustable implant device1012is advanced towards the mitral valve1076(as indicated by the rightwardly pointing arrow) and into the valve1076as shown inFIG. 44C. The implant device positioning element1016seats within the orifice1084of the valve1076, displacing leaflets1082and bringing the adjustable implant device1012into contact with tissue1058adjacent mitral valve1076. In its expanded configuration, as shown in these figures, implant device positioning element1016centers within the valve1076and effectively guides the adjustable implant device1012into proper position around and adjacent the human mitral valve1076in contact with the mitral valve annulus1086. Thus, the implant device positioning element1016is effective to direct the adjustable implant device1012into proper position in contact with the mitral valve annulus1086, and to orient the adjustable implant device1012substantially along valve plane1088(which is substantially perpendicular to the path of blood flow through the valve1076) for proper placement for attachment to the mitral valve annulus1086for repair or adjustment of a human mitral valve1076. For example, such repair or adjustment of a human mitral valve1076may be accomplished by adjusting a dimension of an adjustable implant device1012, such as a perimeter1021of the adjustable implant device1012, effective to adjust a size or perimeter of the valve1076to effect a repair of the valve1076.

A similar sequence is presented inFIGS. 45A-45G, showing an adjustable implant device1012, an implant device positioning element1016and a tool1014operably connected with an adjustment member1018via an adjustment coupler1019. InFIG. 45A, an implant device positioning element1016is shown in partial schematic side-view, and shown as a whisk of flexible wire-shaped material, carrying an adjustable implant device1012having features of the invention and shown in schematic cross-sectional view. The tool1014is disposed in a non-planar configuration with respect to the adjustable implant device1012. The adjustable implant device1012is illustrated in a reduced diameter configuration inFIG. 45A, and in an expanded diameter inFIG. 45B. The adjustable implant device1012is placed in its expanded configuration by action of the adjustment tool1014being operated (indicated by the curved arrow inFIG. 45B) to expand a perimeter1021of the adjustable implant device1012. Expansion of the adjustable implant device1012is indicated by the vertical arrows inFIG. 45B. As the adjustable implant device1012expands, the implant positioning element1016may expand due to release of constraint, where the implant positioning element1016is resilient or otherwise under tension in a contracted configuration. In embodiments, the implant positioning element1016may expand by direct action of the expansion of the adjustable implant device1012where the implant positioning element1016is attached, fastened, or otherwise linked to the adjustable implant device1012.

Placement of an adjustable implant device1012adjacent a mitral valve annulus1086with a system1011having features of the invention is shown inFIGS. 45C, D and E.FIG. 45Cprovides a schematic partial cross-sectional side view showing distal portions of an implant device positioning element1016carrying an adjustable implant device1012and having an adjustment tool1014operably connected to the adjustable implant device1012via adjustment member1018and adjustment tool coupler1019. Mitral valve1076, mitral valve annulus1086, and leaflets1082are shown in these figures. As the assembly including an implant device positioning element1016, adjustable implant device1012and adjustment tool1014approaches the mitral valve annulus1086, the adjustable implant device1012(which substantially defines a plane) is disposed in an orientation with its plane substantially coplanar with the mitral valve annulus1086, and the tool1014is disposed in an orientation in which its longitudinal axis is substantially non-planar with the plane of the mitral valve annulus1086and with the plane of the adjustable implant device1012.

The assembly including an implant device positioning element1016, adjustable implant device1012and adjustment tool1014is shown inFIG. 45Cwith the implant device positioning element1016in a contracted configuration within a left atrium1078. Operation of adjustment tool1014, as indicated by the curved arrow inFIG. 45D, expands adjustable implant device1012and expands (or allows expansion of) implant device positioning element1016. Expanded adjustable implant device1012better approximates the proper size for placement on mitral valve annulus1086. Advancement of assembly that includes implant device positioning element1016, adjustable implant device1012and adjustment tool1014, with the adjustable implant device1012and implant device positioning element1016in expanded configurations, as shown inFIG. 45E, displaces leaflets1082and places adjustable implant device1012in position in contact with mitral valve annulus1086and ready for securing to the annulus1086. As is shown in these figures, implant device positioning element1016is effective to properly position an adjustable implant device1012, by properly centering the device so that it does not overlap the valve orifice1084(occupied by the implant positioning element1016) and is in contact with the valve annulus1086. Blood flow is not blocked by these devices and methods, and damage or improper placement of valve leaflets1082is also avoided using these devices and methods.

An adjustable implant device having features of the invention may include an adjustable perimeter or shape, and a perimeter or shape adjustment mechanism that is operably connected with a docking element. A docking element may be configured to operably engage an adjustment tool. An adjustment tool may be configured to operate with the docking element effective to adjust a perimeter or shape of the adjustable implant device.

An adjustable implant device having features of the invention is shown inFIGS. 46A,46B and46C. These figures provide three related views of an implant device having features of the invention: a schematic side view of such a device (FIG. 46A), a cross-section through the device crossing the docking element and adjustment mechanism, along a plane parallel to a longitudinal axis of a cylinder oriented to pass through the inner space defined by the ring of the implant device (FIG. 46B); and a cross-sectional view taken along a plane through the device in a plane perpendicular to a longitudinal axis of a cylinder oriented to pass through the inner space defined by the ring of the implant device (FIG. 46C). The plane of the cross-section illustrated inFIG. 46Cis parallel to a plane of tissue that would be found when the device was in place on a heart valve annulus.

As shown inFIG. 46A, an implant device1100having features of the invention includes an annular body1102and an adjustment mechanism1104. An annular body1104may have a substantially circular shape, or an oval shape, or a rounded trapezoidal shape (as illustrated, for example, inFIG. 46C), or any suitable shape. Such a suitable shape may be a closed curve, as illustrated inFIG. 46C, or may be an open curve.

It will be understood that, in embodiments, a suitable shape may be an open shape, in which an annular body1102has an elongated body portion having two free ends. In embodiments having an annular body1102having two free ends, an elongated body portion may be curved, and the free ends may be disposed near to each other. In embodiments having a curved annular body1102having two free ends disposed near to each other, the device1100may be configured to adjust the distance between the free ends (e.g., a ribbon or thread of material may connect the free ends, and may be configured to draw the free ends towards each other).

For example, as illustrated inFIG. 46D, an annular body1102of an adjustable implant device1100having features of the invention may not form a closed loop, but may instead be configured with two free ends1103instead of forming a continuous, closed loop structure. The configuration of such a device, including the closeness and angle of approach of the two free ends1103to each other, may be adjusted and controlled and serve to adjust a size and/or a shape of an adjustable implant device1100and to adjust a size and/or a shape of an anatomical orifice or lumen to which such an adjustable implant device1100is attached. An adjustment mechanism1104may be used to make such adjustments in a size and/or a shape of an adjustable implant device1100. For example, an adjustment mechanism1104may be operably connected with internal guides, cables, slides, wires, and/or other elements effective to adjust the position, orientation, and placement of an end1103or of both ends1103, and of other portions or elements of an annulur body1102and of an adjustable plant device1100as a whole.

As illustrated inFIG. 46E, such free ends1103may be connected by a connecting element1105. Such a connecting element1105may be, for example, a thread, suture, ribbon, cable, filament, wire, braided wire, bar, threaded bar, or other element. The connecting element1105is illustrated inFIG. 46Das a thread. In embodiments having features of the invention, the connecting element1105may be very flexible, may be somewhat flexible, may be barely flexible, and may be substantially inflexible. An adjustment mechanism1104may be used to make such adjustments in a size and/or a shape of an adjustable implant device1100. For example, an adjustment mechanism1104may be operably connected with such a thread effective to adjust the position, orientation, and placement of an end1103or of both ends1103and of other portions or elements of an annulur body1102and of an adjustable plant device1100as a whole.

An illustration of a further embodiment of an adjustable implant device1100having features of the invention is shown inFIG. 46F. An adjustable implant device1100having features of the invention that does not form a closed loop, and having free ends1103, may have an elongated connecting element1105that extends away from the adjustable implant device1100in two places. One or both of the ends1107may be suitable for manipulation by an operator, such as a surgeon. For example, pulling on an elongated connecting element1105configured as illustrated inFIG. 46Fmay pull on connected portions of the elongated connecting element1105, effective to contract a portion of, or structure on or within, a portion of annular body1102of an adjustable implant device1100, and may alter a size and/or shape of the adjustable implant device1100.

In further embodiments, as illustrated, for example, inFIG. 46G, an adjustable implant device1100having features of the invention and having two free ends1103may have free ends1103connected to each other by a connecting element1105. The connecting element1105may itself have ends1107which extend away from the adjustable implant device1100. One or both of the ends1107may be suitable for manipulation by an operator, such as a surgeon. For example, pulling on an elongated connecting element1105configured as illustrated inFIG. 46Gmay be effective to draw ends1107closer together, and so to alter a size and/or shape of the adjustable implant device1100.

FIG. 46Hprovides a schematic view of an embodiment of an adjustable implant device having features of the invention that does form a closed loop, and that has an elongated connecting element1105(shown here as a thread) that, in two places, extends away from the body of the adjustable implant device. One or both of the ends1107may be suitable for manipulation by an operator, such as a surgeon. For example, pulling on an elongated connecting element1105configured as illustrated inFIG. 46Hmay pull on connected portions of the elongated connecting element1105, effective to contract a portion of, or structure on or within, a portion of annular body1102of an adjustable implant device1100, and may alter a size and/or shape of the adjustable implant device1100.

FIG. 46Iprovides a schematic view of an embodiment of an adjustable implant device having features of the invention that does form a closed loop, and that has an elongated connecting element1105(shown here as a thread) that, in one place, extends away from the body of the adjustable implant device. Such an end1107may be suitable for manipulation by an operator, such as a surgeon. For example, pulling on the elongated connecting element1105configured as illustrated inFIG. 46Imay pull on connected portions of the elongated connecting element1105, effective to contract a portion of, or structure on or within, a portion of annular body1102of an adjustable implant device1100, and may alter a size and/or shape of the adjustable implant device1100.

An adjustable implant device having features of the invention may include an adjustable perimeter or shape, and a perimeter or shape adjustment mechanism that is operably connected with a docking element. A docking element may be configured to operably engage an adjustment tool. An adjustment tool may be configured to operate with the docking element effective to adjust a perimeter or shape of the adjustable implant device.

Although discussed with respect to devices1100having an annular body1102that is a closed annular body1102, elements of a device1100discussed herein may be similar and may operate in similar ways for devices1100that have open annular bodies1102and for devices1100that have closed annular bodies1102. Thus, although the following discussion is with respect toFIGS. 46A,46B, and46C which show an implant device1100having a closed annular body1102, it will be understood that the discussion also relates to an implant device1100having an open annular body1102.

A device1100has an adjustment mechanism1104that includes a drive gear1106that is operably engaged with a driven gear1108or gears1108. Rotation of drive gear1106is effective to rotate a driven gear1108. In the embodiment shown inFIGS. 46B and 46C, a single drive gear1106engages two driven gears1108effective to adjust a size and/or shape of the device1100. As illustrated inFIGS. 46B and 46C, gears1106and1108may be beveled gears, and may be, for example, worm gears or other gears configured to engage each other with non-parallel axes of rotation.FIG. 46Cshows top thrust bushing1110, against which drive gear1106may push, and also shows side thrust bushings1112in contact with driven gears1108. Gear1106and gears1108are shown disposed within a housing formed from a top gear housing1114and a bottom gear housing1116. Gear1106rotates around pin1118within the housing. A pin1118may be held in place by, for example, a threaded insert1120. It will be understood that a drive gear1106is configured to engage with an adjustment tool, such as an adjustment tool1014as illustrated inFIG. 45, or other adjustment tool having features of the invention. Operation of such an adjustment tool is effective to initiate and control the movement of a drive gear1106effective to drive driven gears1108and to adjust a size and/or shape of a device1100.

Several components are disposed inside the annular body1102of the device1100. For example, threaded spars1122help to provide form and support to the annular body1102, and (as described in more detail below) help couple rotary motion of the gears1108to a change in size and/or shape of the device1100. Gearbox sleeves1124also help to provide form and support to the annular body1102, and provide strength and stability to the interface between the annular ring1102and the adjustment mechanism1104of the device1100.

Guide tube coil1126within annular body1102contains at least two elements, the outer drive coil1128and the inner drive coil1130, which translate rotation of the driven gears1108into rotation of the screws1132within threaded spars1124. Rotation of the screws1132causes movement of the sleeve screws1132within the threaded spars1124and spar sleeves1134, changing a size and/or shape of the annular body1102. For example, rotation of the screws1132causing axial movement of screws1132within threaded spars1124and spar sleeves1134effective that screws1132come closer to each other within spar sleeves1134will cause the perimeter of annular body1102to shrink, so as to change the shape and size of the annular body1102effective that the annular body1102has a smaller internal bore1135. In a further example, rotation of the screws1132causing axial movement of screws1132within threaded spars1124and spar sleeves1134effective that screws1132become farther away from each other within spar sleeves1134will cause the perimeter of annular body1102to enlarge, so as to change the shape and size of the annular body1102effective that the annular body1102has a larger internal bore1135.

A sheath1136, which may comprise, for example, a silicone tube, encloses internal elements of an annular body1102. For example, as shown inFIGS. 46B and 46C, a sheath1136may enclose a gearbox sleeve1124; a coil guide1126and outer and inner drive cQils1128and1130within the coil guide1126; threaded spars1122and sleeves1134; and may enclose other elements. For example, a stop screw1138configured to prevent excessive interaction between screws1132if screws1132are moved to the ends of their travel within threaded spars1122and sleeves1134may also be disposed within a sheath1136.

A seal jacket1140may join with sheath1136to form an enclosure1141. An enclosure1141comprising a seal jacket1140joined with a sheath1136may enclose an adjustment mechanism1104, including elements of the adjustment mechanism gears1106and1108, pin1118and threaded insert1120; bushings1110and1112; top housing1114and bottom housing1116; and may enclose other elements. Seal jacket1140together with sheath1136may enclose many or all of the working elements required for adjusting a size and/or a shape of a device1100having features of the invention. In embodiments, further elements may be disposed, at least in part, on, around, or otherwise outside an enclosure formed by a seal jacket1140joined with sheath1136.

For example, a sewing cuff1142may be disposed around an enclosure1141effective to provide material to which sutures or other securing agents may be attached to a device1100having features of the invention to enable or aid in the attachment of the device1100to tissue. In embodiments, a sewing cuff1142surrounds the entire enclosure1141. However, a sewing cuff1142may enclose only a portion of a device1100; for example, a sewing cuff1142may enclose only a sheath1136, or may only enclose a seal jacket1140. In alternative embodiments, a sewing cuff1142surrounds only a portion of a sheath1136or surrounds only a portion of a seal jacket1140.

Similarly, a suture cuff1144may be disposed on or around a device1100having features of the invention. As shown inFIG. 46C, a suture cuff1144may be disposed on a surface of a device1100effective to provide a location suitable for receiving a suture and for securing the device1100to tissue. In embodiments, a suture cuff1144may surround a portion of the adjustment device1104; or may surround all of, or a portion of the sheath1136; or may surround all of, or a portion of, a seal jacket1140; or may surround all of, or a portion of, the entire enclosure1141. However, a sewing cuff1142may enclose only a portion of a device1100; for example, a sewing cuff1142may enclose only a sheath1136, or may only enclose a seal jacket1140. In alternative embodiments, a sewing cuff1142may surround only a portion of a sheath1136or may surround only a portion of a seal jacket1140.

A sewing cuff1142and/or a suture cuff1144may be made with a material having properties suitable for receiving and retaining sewing materials, such as a needle, thread, suture, cord, wire, or other material suitable for engaging and retaining a device1100to tissue. For example, such materials may include woven materials including fabrics, cloth, woven polymer, woven metal, and other woven materials; mesh, including metal mesh, polymer mesh, fabric mesh, and other mesh; netting, including metal netting, polymer netting, fabric netting, and other netting; and other materials through which a needle or other guide may pass, yet which are strong enough to retain elements which pass through these materials. A sewing cuff1142and/or a suture cuff1144may include elements such as, for example, rings, loops, hoops, coils, and other shapes useful for engaging and retaining elements which pass through such rings, loops, hoops, coils, and other shapes.

As shown inFIGS. 46A and 46C, an implant device1100may include a marker1146. A marker1146may be configured to aid an operator, such as a surgeon, in properly orienting an implant device1100during placement of the device. A marker1146may be configured to aid an operator, such as a surgeon, in properly orienting a suture, clip, or other securing device or securing aid, during placement and/or securing of the device1100at a desired location adjacent tissue. In embodiments, a marker1146may be disposed on an outside surface of a device1100, as shown inFIGS. 46A and 46C. In embodiments, a device1100may carry multiple markers1146.

A marker1146may be perceptible to the unaided eye in normal light, and may be perceptible by a human observer with technical aid. A marker1146may be detectable by other means than by observation by a human observer. For example, a marker1146may be perceptible or identifiable with the aid of particular illumination or of a visualization device. Particular illumination may aid the visualization of a marker1146where, for example, such illumination includes ultraviolet radiation, and the marker1146is configured to reflect or emit visible light during or following illumination by ultraviolet light. Particular illumination and visualization devices may aid the visualization of a marker1146where, for example, the marker is radio-opaque, and the marker is subjected to illumination by radiation (e.g., by X-rays) effective that an image may be obtained showing the approximate location of the device1100.

A marker1146may be disposed on an outside surface of a device1100, as shown inFIGS. 46A and 46C. In embodiments, a marker1146may be disposed within a device1100. A marker1146disposed within a device1100may be detected, for example, where penetrating illumination such as X-ray illumination is used to aid in detection or visualization of the marker. In embodiments, some or all of markers1146carried by a device1100may be disposed on an outer surface of a device1100, and some or all of such markers1146may be disposed within a device1100.

FIG. 47Aprovides a side schematic view of an adjustment tool1150having features of the invention, showing, for example, a handle portion1152, a shaft portion1154, and a distal tip portion1156having an engagement element1158configured to operably engage an adjustment mechanism such as an adjustment mechanism1104illustrated inFIGS. 46A, B and C.FIG. 47Bprovides a face-on schematic view of distal tip portion1156of the adjustment tool1150shown inFIG. 47A.FIG. 47Cprovides an end-on schematic view of the handle portion1154of the adjustment tool1150shown inFIG. 47A.FIG. 47Dprovides a side cross-sectional view of the adjustment tool1150, the cross-section being taken along a plane passing through a longitudinal axis1160of the adjustment tool1150(the cross-section taken along line DD shown inFIG. 47A). A handle portion1152may have more than one portion. As indicated inFIGS. 47A and 47D, a handle portion1152may include a proximal handle portion1162and a distal handle portion1164. Different handle portions may move (e.g., may rotate) independently of the other portion(s). However, in embodiments of the adjustment tools1150having features of the invention, different handle portions may be configured to move together, or to be constrained in their movements, or to be restrained from moving, relative to each other. For example, an adjustment tool1150having features of the invention may include a stop1166or other element configured to brake the movement of one handle portion with respect to another handle portion.

As illustrated in the embodiment shown inFIGS. 47A, B, and C, distal handle portion1164may be fixedly attached to shaft1154, so that rotation of distal handle portion1164rotates shaft1154. In embodiments, such as the embodiment illustrated inFIGS. 47A, B, and C, rotation of inner axle1168rotates distal tip portion1156and rotates engagement element1158. Thus, an operator may hold or manipulate distal handle portion1164to control the position and orientation of an adjustment tool1150, and may also rotate, if desired, proximal handle portion1162effective to control the position and/or orientation of distal tip portion1156and of engagement element1158.

As shown in the embodiment shown inFIGS. 47A, B, and C, a proximal handle portion1162may be configured to be able to rotate with respect to distal handle portion1164, so that rotation of proximal handle portion1162does not cause rotation of shaft1154. However, proximal handle portion1162may be attached to an inner axle1168effective that rotation of proximal handle portion1162causes rotation of inner axle1168while not significantly affecting shaft1154. This allows operation of an adjustment tool1150without damage to tissue that might be caused by rotation of a shaft, and provides for control and guidance of an adjustment tool1150, e.g., by gripping or guiding a shaft1154, while allowing rotation of inner axle1168at the same time. Thus, providing a shaft1154having a rotatable inner axle1168(and handle portions1162and1164for controlling a shaft1154and a rotatable inner axle1168) allows for stable operation of an adjustment tool1150and minimizes the possibility of tissue damage.

An engagement element1158may be secured to an inner axle1168by a connector1170, which may be, for example, a threaded connector1170, and/or may comprise a glue or a weld to secure an engagement element1158to an inner axle1168. As mentioned above, rotation of inner axle1168rotates distal tip portion1156and engagement element1158. For example, rotation of inner axle1168rotates distal tip portion1156having an engagement element1158configured to operably engage an adjustment mechanism such as an adjustment mechanism1104illustrated inFIGS. 46A, B and C. However, when desired, stop1166may be engaged effective to lock a handle portion1162to a handle portion1164so that proximal handle portion1162does not rotate with respect to handle portion1164. For example, during placement of an adjustment tool1150, it may be desirable that proximal handle portion1162not rotate with respect to handle portion1164, or that distal tip portion1156not rotate with respect to shaft1154. Once an adjustment tool1150is in place, with distal tip1156in correct position with respect to an adjustment mechanism1104, and engagement element1158engaged with elements of an adjustment mechanism1104, e.g., effective to operate a drive gear1106, a stop1166may be disengaged to allow free rotation of distal tip portion1156and engagement element1158with respect to shaft1154.

A shaft1154may be made from materials in such a way that the physical properties of the shaft may vary along its length. For example, a shaft1154may be configured to be stiffer at one end as compared to the other end; to be more flexible in a region or location, as compared with other regions or locations along the shaft1154; or to have other varying physical properties. In embodiments, a shaft1154may have a proximal shaft portion1172, a medial shaft portion1174, and a distal shaft portion1176. Shaft portions1172,1174, and1176may have different physical properties, and may be configured to provide, for example, a shaft1154that is flexible; a shaft1154that is strong; a shaft1154that is sterilizable; a shaft1154that is resistant to corrosion; a shaft1154that has shape memory properties; a shaft1154that may be bent, and retain the bent shape; a shaft1154that may be bent, retain the bent shape, and allow rotation of an engagement element at a distal portion of the shaft1154; or combinations of some or all of these and other properties.

For example, a shaft1154may be made of a single material, compound or composite, or may be made with different components operably joined together. A shaft1154may be flexible, and may include curves, bends, or other shapes, while still allowing rotation of an inner axle1168. A shaft1154and an inner axle1168may be made with, for example, e.g., a metal, such as, e.g., stainless steel; a plastic, such as, for example; a polymer, such as, e.g., polyethylene, polycarbonate, polyurethane, or other polymer; a polyether block amide (PEbax); metal tube or tubes; an alloy, such as, e.g., a nickel titanium alloy such as nitinol; an organic fiber, such as carbon fiber; metal or carbon fiber braid; a polymer including metal or carbon fiber braid; or other material or combinations and mixtures of materials.

In such embodiments, where a proximal portion1172comprises high density polyethylene (HDPE), a medial portion1174comprises composite PEbax with stainless steel braid, and a distal portion1176comprises composite PEbax with stainless steel braid, the distal portion1176having less dense PEbax than the medial portion1174, the shaft1154is flexible yet strong, and can be bent or curved during use without breaking and without destroying its ability to guide and rotate inner axle1168effective to operably control an adjustment mechanism1104, such as to rotate a drive gear1106effective to change a size and/or shape of an adjustable implant device having features of the invention (e.g., an adjustable implant device1100).

In embodiments of adjustment tools1150having features of the invention, a proximal shaft portion1172may be made with HDPE tubing; and a medial shaft portion1174and a distal shaft portion1176may be made with a composite material comprising Polyether block amide (PEbax) and stainless steel braid. In embodiments, medial shaft portion1174may be made with a composite material comprising 72D PEbax and 0.002 inch stainless steel braid. In embodiments, distal shaft portion1176may be made with a composite material comprising 55D PEbax and 0.002 inch stainless steel braid. In such embodiments, where a proximal portion1172comprises HDPE, a medial portion1174comprises composite PEbax with stainless steel braid, and a distal portion1176comprises composite PEbax with stainless steel braid, the distal portion1176having less dense PEbax than the medial portion1174, the shaft1154is flexible yet strong, and can be bent or curved during use without breaking and without destroying its ability to guide and rotate inner axle1168effective to operably control an adjustment mechanism1104, such as to rotate a drive gear1106effective to change a size and/or shape of an adjustable implant device having features of the invention (e.g., an adjustable implant device1100).

Thus, the methods, devices and systems disclosed herein provide advantages over the prior art, and provide means for repair and adjustment of anatomical orifices and lumens, such as a mitral valve, that are needed in the art. It will be understood that features disclosed and described with respect to one exemplary embodiment disclosed herein may also be combined with features disclosed and described with respect to any other exemplary embodiment or embodiments disclosed herein. Materials disclosed and described as being suitable for use with respect to one exemplary embodiment disclosed herein may also be used respect to other exemplary embodiments, and may be used with other materials disclosed and described with respect to any other exemplary embodiment or embodiments disclosed herein.

Further, it should be apparent to those skilled in the art that various changes in form and details of the invention as shown and described may be made. It is intended that such changes be included within the spirit and scope of the claims appended hereto.